Federal Register Vol. 82, No.150,

Federal Register Volume 82, Issue 150 (August 7, 2017)

Page Range36687-36989
FR Document

82_FR_150
Current View
Page and SubjectPDF
82 FR 36848 - CSX Transportation, Inc.-Abandonment Exemption-in Harlan County, KYPDF
82 FR 36834 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Revision of a Currently Approved Collection; Final Disposition Report (R-84)PDF
82 FR 36733 - Meeting of the President's Advisory Council on Doing Business in Africa (PAC-DBIA)PDF
82 FR 36849 - Noise Exposure Map Determination, Centennial Airport, Englewood, COPDF
82 FR 36805 - Announcement of Meeting of the Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2030PDF
82 FR 36799 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prescription Drug AdvertisementsPDF
82 FR 36769 - Agency Information Collection Activities: 60-Day Public Comment RequestPDF
82 FR 36728 - Proposed Information Collection; Comment Request; Annual Business Survey (ABS)PDF
82 FR 36827 - Call for Nominations and Comments for the National Petroleum Reserve in Alaska Oil and Gas Lease SalePDF
82 FR 36756 - Arms Sales NotificationPDF
82 FR 36771 - Formations of, Acquisitions by, and Mergers of Bank Holding CompaniesPDF
82 FR 36770 - Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding CompanyPDF
82 FR 36760 - Notice of Availability of The Great Lakes and Mississippi River Interbasin Study-Brandon Road Draft Integrated Feasibility Study and Environmental Impact Statement-Will County, IllinoisPDF
82 FR 36835 - New Postal ProductsPDF
82 FR 36758 - Arms Sales NotificationPDF
82 FR 36854 - Open Meeting of the Taxpayer Advocacy Panel Notices and Correspondence Project CommitteePDF
82 FR 36855 - Open Meeting of the Taxpayer Advocacy Panel Tax Forms and Publications Project CommitteePDF
82 FR 36854 - Open Meeting of the Taxpayer Advocacy Panel Taxpayer Assistance Center Improvements Project CommitteePDF
82 FR 36854 - Open Meeting of the Taxpayer Advocacy Panel Joint CommitteePDF
82 FR 36855 - Open Meeting of the Taxpayer Advocacy Panel Special Projects CommitteePDF
82 FR 36856 - Advisory Committee on Disability Compensation, Notice of MeetingPDF
82 FR 36705 - Products Containing Organohalogen Flame Retardants; Notice of Opportunity for Oral Presentation of CommentsPDF
82 FR 36755 - Uniform Formulary Beneficiary Advisory Panel; Notice of Federal Advisory Committee MeetingPDF
82 FR 36855 - Open Meeting of the Taxpayer Advocacy Panel Taxpayer Communications Project CommitteePDF
82 FR 36854 - Open Meeting of the Taxpayer Advocacy Panel Toll-Free Phone Line Project CommitteePDF
82 FR 36802 - National Vaccine Injury Compensation Program; List of Petitions ReceivedPDF
82 FR 36689 - Atlantic Highly Migratory Species; Atlantic Bluefin Tuna FisheriesPDF
82 FR 36805 - Meeting of the Advisory Commission on Childhood VaccinesPDF
82 FR 36792 - Product-Specific Guidances; Final Guidances for Industry; AvailabilityPDF
82 FR 36795 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry-User Fee Waivers, Reductions, and Refunds for Drug and Biological ProductsPDF
82 FR 36737 - Certain Pasta From Turkey: Preliminary Results of Antidumping Duty Administrative ReviewPDF
82 FR 36730 - Monosodium Glutamate From the People's Republic of China: Preliminary Results of the Antidumping Duty Administrative Review; 2015-2016PDF
82 FR 36752 - Fresh Garlic From the People's Republic of China: Final Results of Fourth Expedited Sunset Review of the Antidumping Duty OrderPDF
82 FR 36746 - Xanthan Gum From the People's Republic of China: Preliminary Results of the Antidumping Duty Administrative Review and Preliminary Determination of No Shipments; 2015-2016PDF
82 FR 36732 - Certain Stilbenic Optical Brightening Agents From the People's Republic of China and Taiwan: Final Results of the Expedited Sunset Reviews of the Antidumping Duty OrdersPDF
82 FR 36734 - Drawn Stainless Steel Sinks From the People's Republic of China: Notice of Rescission of Countervailing Duty Administrative Review, 2016PDF
82 FR 36934 - Repeal of Consolidated Federal Oil & Gas and Federal & Indian Coal Valuation ReformPDF
82 FR 36755 - Submission for OMB Review; Comment RequestPDF
82 FR 36765 - Information Collection Being Reviewed by the Federal Communications CommissionPDF
82 FR 36766 - Information Collection Being Reviewed by the Federal Communications Commission Under Delegated AuthorityPDF
82 FR 36797 - Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed BiologicsPDF
82 FR 36768 - Information Collection Being Reviewed by the Federal Communications CommissionPDF
82 FR 36767 - Information Collections Being Submitted for Review and Approval to the Office of Management and BudgetPDF
82 FR 36792 - Agency Information Collection Activities; Proposed Collection; Comment Request; Safety Assurance Case; Withdrawal of NoticePDF
82 FR 36762 - Notice of Availability of Guidance and Application for Hydroelectric Incentive ProgramPDF
82 FR 36692 - Proprietary Trading and Certain Interests in and Relationships With Covered Funds (Volcker Rule); Request for Public InputPDF
82 FR 36827 - Notice of Filing of Plats of Survey, ColoradoPDF
82 FR 36828 - Certain Shielded Electrical Ribbon Cables and Products Containing the Same; Institution of InvestigationPDF
82 FR 36848 - Notice of Determinations; Culturally Significant Objects Imported for Exhibition Determinations: “Technologies of the Image: Art in 19th-Century Iran” ExhibitionPDF
82 FR 36847 - Notice of Determinations; Culturally Significant Objects Imported for Exhibition Determinations: “Things of Beauty Growing: British Studio Pottery” ExhibitionPDF
82 FR 36749 - Certain Steel Nails From the Republic of Korea: Preliminary Results of Antidumping Duty Administrative Review and Partial Rescission of Antidumping Duty Administrative Review; 2014-2016PDF
82 FR 36846 - Presidential Declaration of a Major Disaster for Public Assistance Only for the State of NebraskaPDF
82 FR 36764 - Dosch, Theodore A.; Notice of FilingPDF
82 FR 36763 - Exelon FitzPatrick, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 AuthorizationPDF
82 FR 36763 - Combined Notice of Filings #2PDF
82 FR 36764 - Combined Notice of Filings #1PDF
82 FR 36728 - Submission for OMB Review; Comment RequestPDF
82 FR 36705 - Periodic ReportingPDF
82 FR 36761 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; U.S. Department of Education Supplemental Information for the SF-424 FormPDF
82 FR 36827 - Agency Notice of Webinar; Announcement of U.S. Geological Survey (USGS), National Geospatial Program (NGP) 3D Elevation Program (3DEP) FY17 Informational Training Webinars in Preparation for the Upcoming Release of the USGS Broad Agency Announcement (BAA) for 3D Elevation Program (3DEP)PDF
82 FR 36826 - Foreign Endangered Species; Issuance of PermitsPDF
82 FR 36846 - Administrative Declaration of a Disaster for the State of AlabamaPDF
82 FR 36847 - Administrative Declaration of a Disaster for the State of California.PDF
82 FR 36845 - Administrative Declaration of a Disaster for the State of TexasPDF
82 FR 36846 - Administrative Declaration of a Disaster for the State of CaliforniaPDF
82 FR 36807 - National Institute of Biomedical Imaging and Bioengineering; Notice of Closed MeetingPDF
82 FR 36853 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel SERENDIPITY; Invitation for Public CommentsPDF
82 FR 36851 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel REHAB; Invitation for Public CommentsPDF
82 FR 36850 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel MEDORA; Invitation for Public CommentsPDF
82 FR 36851 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel LUNA; Invitation for Public CommentsPDF
82 FR 36852 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel LANIKAI; Invitation for Public CommentsPDF
82 FR 36850 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel BELLA VIT; Invitation for Public CommentsPDF
82 FR 36852 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel ALICE ANNE; Invitation for Public CommentsPDF
82 FR 36808 - Prospective Grant of Exclusive Patent License: The Development of a Bispecific, Biparatopic Antibody-Drug Conjugate to GPC3 for the Treatment of Human Liver CancersPDF
82 FR 36809 - Prospective Grant of Exclusive Patent License: MicroRNA Therapeutics for Treating Squamous Cell CarcinomasPDF
82 FR 36807 - National Institute of Allergy and Infectious Diseases; Notice of Closed MeetingPDF
82 FR 36809 - National Institute on Aging; Notice of Closed MeetingPDF
82 FR 36806 - Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Notice of MeetingPDF
82 FR 36796 - Vaccines and Related Biological Products Advisory Committee; Notice of MeetingPDF
82 FR 36789 - Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for CommentsPDF
82 FR 36706 - Periodic ReportingPDF
82 FR 36790 - Determination of Regulatory Review Period for Purposes of Patent Extension; CINQAIRPDF
82 FR 36794 - Determination of Regulatory Review Period for Purposes of Patent Extension; VONVENDIPDF
82 FR 36836 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Designation of a Longer Period for Commission Action on a Proposed Rule Change To Adopt FINRA Rule 6898 (Consolidated Audit Trail-Fee Dispute Resolution)PDF
82 FR 36837 - Self-Regulatory Organizations; Investors Exchange LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Adopt a Policy Relating to Its Treatment of Trade Reports That It Determines To Be Inconsistent With the Prevailing MarketPDF
82 FR 36771 - Formations of, Acquisitions by, and Mergers of Savings and Loan Holding CompaniesPDF
82 FR 36844 - Northern Lights Fund Trust and Toews CorporationPDF
82 FR 36839 - MVC Capital, Inc., et al.PDF
82 FR 36687 - Drawbridge Operation Regulation; Lake Washington Ship Canal, Seattle, WAPDF
82 FR 36856 - Advisory Committee on Prosthetics and Special-Disabilities Programs; Notice of MeetingPDF
82 FR 36688 - Safety Zone; North Atlantic Ocean, Ocean City, NJPDF
82 FR 36812 - Information Collection Request to Office of Management and Budget; OMB Control Number: 1625-0057PDF
82 FR 36811 - Collection of Information Under Review by Office of Management and Budget; OMB Control Number: 1625-0074PDF
82 FR 36810 - Information Collection Request to Office of Management and Budget; OMB Control Number: 1625-0062PDF
82 FR 36735 - Polyethylene Terephthalate Film, Sheet, and Strip From India: Preliminary Results and Partial Rescission of Antidumping Duty Administrative Review; 2015-2016PDF
82 FR 36731 - Certain Steel Nails From the United Arab Emirates: Final Results of the Expedited First Sunset Review of the Antidumping Duty OrderPDF
82 FR 36744 - Certain Steel Nails From Taiwan: Preliminary Results of Antidumping Duty Administrative Review and Partial Rescission of Administrative Review; 2015-2016PDF
82 FR 36738 - Certain Steel Nails From the Sultanate of Oman: Preliminary Results of Antidumping Duty Administrative Review and Partial Rescission of Antidumping Duty Administrative Review; 2014-2016PDF
82 FR 36741 - Certain Steel Nails From Malaysia: Preliminary Results and Partial Rescission of Antidumping Duty Administrative Review; 2014-2016PDF
82 FR 36801 - Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Information Collection Request Title: AIDS Drug Assistance Program Data Report, OMB No. 0915-0345-ExtensionPDF
82 FR 36713 - National Emission Standards for Hazardous Air Pollutants: Off-Site Waste and Recovery OperationsPDF
82 FR 36688 - Revisions to Test Methods, Performance Specifications, and Testing Regulations for Air Emission Sources; Technical CorrectionPDF
82 FR 36707 - Air Plan Approval; Kentucky; Regional Haze Progress ReportPDF
82 FR 36829 - Steel Concrete Reinforcing Bar From Taiwan; Supplemental Schedule for the Subject InvestigationPDF
82 FR 36754 - Procurement List: AdditionPDF
82 FR 36753 - Procurement List; Proposed Additions and DeletionsPDF
82 FR 36719 - Rulemaking Procedures UpdatePDF
82 FR 36724 - International Fisheries; Pacific Tuna Fisheries; Restrictions on Fishing for Sharks in the Eastern Pacific OceanPDF
82 FR 36830 - Proposed Aggregate Production Quotas for Schedule I and II Controlled Substances and Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2018PDF
82 FR 36771 - Medicare Program; FY 2018 Inpatient Psychiatric Facilities Prospective Payment System-Rate UpdatePDF
82 FR 36812 - Allocations, Common Application, Waivers, and Alternative Requirements for Community Development Block Grant Disaster Recovery GranteesPDF
82 FR 36835 - Advisory Board; Notice of MeetingPDF
82 FR 36697 - Use of Automatic Dependent Surveillance-Broadcast (ADS-B) Out in Support of Reduced Vertical Separation Minimum (RVSM) OperationsPDF
82 FR 36858 - Energy Conservation Program: Test Procedure for Dedicated-Purpose Pool PumpsPDF

Issue

82 150 Monday, August 7, 2017 Contents Agriculture Agriculture Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 36728 2017-16544 Census Bureau Census Bureau NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Annual Business Survey, 36728-36730 2017-16605 Centers Medicare Centers for Medicare & Medicaid Services NOTICES Medicare Program: FY 2018 Inpatient Psychiatric Facilities Prospective Payment System—Rate Update, 36771-36789 2017-16430 Coast Guard Coast Guard RULES Drawbridge Operations: Lake Washington Ship Canal, Seattle, WA, 36687-36688 2017-16502 2017-16508 Safety Zones: North Atlantic Ocean, Ocean City, NJ, 36688 2017-16506 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 36810-36812 2017-16505 2017-16503 2017-16504 Commerce Commerce Department See

Census Bureau

See

International Trade Administration

See

National Oceanic and Atmospheric Administration

Committee for Purchase Committee for Purchase From People Who Are Blind or Severely Disabled NOTICES Procurement List; Additions and Deletions, 36753-36755 2017-16472 2017-16473 Comptroller Comptroller of the Currency PROPOSED RULES Proprietary Trading and Certain Interests in and Relationships with Covered Funds (Volcker Rule), 36692-36697 2017-16556 Consumer Product Consumer Product Safety Commission PROPOSED RULES Products Containing Organohalogen Flame Retardants, 36705 2017-16588 Defense Department Defense Department See

Engineers Corps

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 36755-36756 2017-16567 Arms Sales, 36756-36760 2017-16595 2017-16603 Meetings: Uniform Formulary Beneficiary Advisory Panel, 36755 2017-16587
Drug Drug Enforcement Administration NOTICES Established Aggregate Production Quotas for Schedule I and II Controlled Substances: Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2018, 36830-36834 2017-16439 Education Department Education Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Supplemental Information for the SF-424 form, 36761-36762 2017-16542 Energy Department Energy Department See

Energy Efficiency and Renewable Energy Office

See

Federal Energy Regulatory Commission

RULES Energy Conservation Program: Test Procedure for Dedicated-Purpose Pool Pumps, 36858-36931 2017-15464
Energy Efficiency Energy Efficiency and Renewable Energy Office NOTICES Guidance: Hydroelectric Incentive Program, 36762-36763 2017-16559 Engineers Engineers Corps NOTICES Environmental Impact Statements; Availability, etc.: Great Lakes and Mississippi River Interbasin Study: Brandon Road Draft Feasibility Study, Will County, IL, 36760-36761 2017-16597 Environmental Protection Environmental Protection Agency RULES Revisions to Test Methods, Performance Specifications, and Testing Regulations for Air Emission Sources; Technical Correction, 36688-36689 2017-16493 PROPOSED RULES Air Quality State Implementation Plans; Approvals and Promulgations: Kentucky; Regional Haze Progress Report, 36707-36713 2017-16484 National Emission Standards for Hazardous Air Pollutants: Off-Site Waste and Recovery Operations, 36713-36719 2017-16494 Federal Aviation Federal Aviation Administration PROPOSED RULES Use of Automatic Dependent Surveillance-Broadcast (ADS-B) Out in Support of Reduced Vertical Separation Minimum (RVSM) Operations, 36697-36705 2017-16197 NOTICES Noise Exposure Map Determinations: Centennial Airport, Englewood, CO, 36849 2017-16609 Federal Communications Federal Communications Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 36765-36769 2017-16562 2017-16563 2017-16565 2017-16566 Federal Energy Federal Energy Regulatory Commission NOTICES Combined Filings, 36763-36765 2017-16545 2017-16546 Filings: Theodore A. Dosch, 36764 2017-16548 Initial Market-Based Rate Filings Including Requests for Blanket Section 204 Authorizations: Exelon FitzPatrick, LLC, 36763 2017-16547 Federal Maritime Federal Maritime Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 36769-36770 2017-16606 Federal Motor Federal Motor Carrier Safety Administration PROPOSED RULES Rulemaking Procedures Update, 36719-36724 2017-16452 Federal Reserve Federal Reserve System NOTICES Changes in Bank Control: Acquisitions of Shares of a Bank or Bank Holding Company, 36770-36771 2017-16600 Formations of, Acquisitions by, and Mergers of Bank Holding Companies, 36771 2017-16601 Formations of, Acquisitions by, and Mergers of Savings and Loan Holding Companies, 36771 2017-16512 Fish Fish and Wildlife Service NOTICES Foreign Endangered Species Permits, 36826-36827 2017-16540 Food and Drug Food and Drug Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Guidance for Industry—User Fee Waivers, Reductions, and Refunds for Drug and Biological Products, 36795-36796 2017-16580 Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics, 36797-36799 2017-16564 Prescription Drug Advertisements, 36799-36801 2017-16607 Safety Assurance Case; Withdrawal, 36792 2017-16561 Guidance: Product-Specific Guidances, 36792-36794 2017-16581 Meetings: Oncologic Drugs Advisory Committee, 36789-36790 2017-16518 Vaccines and Related Biological Products Advisory Committee, 36796-36797 2017-16519 Regulatory Review Period for Patent Extensions: CINQAIR, 36790-36792 2017-16516 VONVENDI, 36794-36795 2017-16515 Geological Geological Survey NOTICES Meetings: National Geospatial Program 3D Elevation Program FY17 Informational Training Webinars, 36827 2017-16541 Health and Human Health and Human Services Department See

Centers for Medicare & Medicaid Services

See

Food and Drug Administration

See

Health Resources and Services Administration

See

National Institutes of Health

NOTICES Meetings: Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2030, 36805-36806 2017-16608
Health Resources Health Resources and Services Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: AIDS Drug Assistance Program Data Report, 36801-36802 2017-16495 Meetings: Advisory Commission on Childhood Vaccines, 36805 2017-16582 National Vaccine Injury Compensation Program Petitions:, 36802-36804 2017-16584 Homeland Homeland Security Department See

Coast Guard

Housing Housing and Urban Development Department NOTICES Community Development Block Grants: Allocations, Common Application, Waivers, and Alternative Requirements for Disaster Recovery Grantees, 36812-36826 2017-16411 Interior Interior Department See

Fish and Wildlife Service

See

Geological Survey

See

Land Management Bureau

See

Office of Natural Resources Revenue

Internal Revenue Internal Revenue Service NOTICES Meetings: Taxpayer Advocacy Panel Joint Committee, 36854 2017-16591 Taxpayer Advocacy Panel Notices and Correspondence Project Committee, 36854 2017-16594 Taxpayer Advocacy Panel Special Projects Committee, 36855 2017-16590 Taxpayer Advocacy Panel Tax Forms and Publications Project Committee, 36855 2017-16593 Taxpayer Advocacy Panel Taxpayer Assistance Center Improvements Project Committee, 36854 2017-16592 Taxpayer Advocacy Panel Taxpayer Communications Project Committee, 36855 2017-16586 Taxpayer Advocacy Panel Toll-Free Phone Line Project Committee, 36854-36855 2017-16585 International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Certain Pasta from Turkey, 36737-36738 2017-16577 Certain Steel Nails from Malaysia, 36741-36744 2017-16496 Certain Steel Nails from Taiwan, 36744-36746 2017-16498 Certain Steel Nails from the Republic of Korea, 36749-36752 2017-16551 Certain Steel Nails from the Sultanate of Oman, 36738-36741 2017-16497 Certain Steel Nails from the United Arab Emirates, 36731-36732 2017-16500 Certain Stilbenic Optical Brightening Agents from the People's Republic of China and Taiwan, 36732-36733 2017-16573 Drawn Stainless Steel Sinks from the People's Republic of China, 36734-36735 2017-16572 Fresh Garlic from the People's Republic of China, 36752-36753 2017-16575 Monosodium Glutamate from the People's Republic of China, 36730-36731 2017-16576 Polyethylene Terephthalate Film, Sheet, and Strip from India, 36735-36736 2017-16501 Xanthan Gum from the People's Republic of China, 36746-36749 2017-16574 Meetings: President's Advisory Council on Doing Business in Africa, 36733-36734 2017-16610 International Trade Com International Trade Commission NOTICES Investigations; Determinations, Modifications, and Rulings, etc.: Certain Shielded Electrical Ribbon Cables and Products Containing the Same, 36828-36829 2017-16554 Steel Concrete Reinforcing Bar from Taiwan, 36829 2017-16480 Justice Department Justice Department See

Drug Enforcement Administration

See

National Institute of Corrections

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Final Disposition Report, 36834-36835 2017-16613
Land Land Management Bureau NOTICES Plats of Survey: Colorado, 36827-36828 2017-16555 Requests for Nominations: National Petroleum Reserve in Alaska Oil and Gas Lease Sale, 36827 2017-16604 Maritime Maritime Administration NOTICES Requests for Administrative Waivers of the Coastwise Trade Laws: Vessel ALICE ANNE, 36852-36853 2017-16526 Vessel BELLA VIT, 36850-36851 2017-16527 Vessel LANIKAI, 36852 2017-16528 Vessel LUNA, 36851-36852 2017-16529 Vessel MEDORA, 36850 2017-16530 Vessel REHAB, 36851 2017-16531 Vessel SERENDIPITY, 36853-36854 2017-16532 National Institute Corrections National Institute of Corrections NOTICES Meetings: Advisory Board, 36835 2017-16382 National Institute National Institutes of Health NOTICES Exclusive Patent Licenses: Development of a Bispecific, Biparatopic Antibody-Drug Conjugate to GPC3 for the Treatment of Human Liver Cancers, 36808-36809 2017-16525 MicroRNA Therapeutics For Treating Squamous Cell Carcinomas, 36809-36810 2017-16524 Meetings: Eunice Kenney Shriver National Institute of Child Health and Human Development, 36806-36807 2017-16520 National Institute of Allergy and Infectious Diseases, 36807-36808 2017-16522 2017-16523 National Institute of Biomedical Imaging and Bioengineering, 36807 2017-16533 National Institute on Aging, 36809 2017-16521 National Oceanic National Oceanic and Atmospheric Administration RULES Atlantic Highly Migratory Species: Atlantic Bluefin Tuna Fisheries, 36689-36691 2017-16583 PROPOSED RULES International Fisheries: Pacific Tuna Fisheries; Restrictions on Fishing for Sharks in the Eastern Pacific Ocean, 36724-36727 2017-16448 Natural Resources Office of Natural Resources Revenue RULES Repeal of Consolidated Federal Oil & Gas and Federal & Indian Coal Valuation Reform, 36934-36989 2017-16571 Postal Regulatory Postal Regulatory Commission PROPOSED RULES Periodic Reporting, 36705-36707 2017-16517 2017-16543 NOTICES New Postal Products, 36835-36836 2017-16596 Securities Securities and Exchange Commission NOTICES Applications: MVC Capital, Inc., et al., 36839-36843 2017-16510 Northern Lights Fund Trust and Toews Corp., 36844-36845 2017-16511 Self-Regulatory Organizations; Proposed Rule Changes: Financial Industry Regulatory Authority, Inc., 36836-36837 2017-16514 Investors Exchange, LLC, 36837-36839 2017-16513 Small Business Small Business Administration NOTICES Disaster Declarations: Alabama, 36846 2017-16539 California, 36846-36847 2017-16535 2017-16538 Nebraska, 36846 2017-16549 Texas, 36845-36846 2017-16537 State Department State Department NOTICES Culturally Significant Objects Imported for Exhibition: Technologies of the Image—Art in 19th-Century Iran, 36848 2017-16553 Things of Beauty Growing—British Studio Pottery, 36847-36848 2017-16552 Surface Transportation Surface Transportation Board NOTICES Abandonment Exemptions: CSX Transportation, Inc., Harlan County, KY, 36848 2017-16654 Transportation Department Transportation Department See

Federal Aviation Administration

See

Federal Motor Carrier Safety Administration

See

Maritime Administration

Treasury Treasury Department See

Comptroller of the Currency

See

Internal Revenue Service

Veteran Affairs Veterans Affairs Department NOTICES Meetings: Advisory Committee on Disability Compensation, 36856 2017-16589 Advisory Committee on Prosthetics and Special-Disabilities Programs, 36856 2017-16507 Separate Parts In This Issue Part II Energy Department, 36858-36931 2017-15464 Part III Interior Department, Office of Natural Resources Revenue, 36934-36989 2017-16571 Reader Aids

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

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82 150 Monday, August 7, 2017 Rules and Regulations DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 117 [Docket No. USCG-2017-0721] Drawbridge Operation Regulation; Lake Washington Ship Canal, Seattle, WA AGENCY:

Coast Guard, DHS.

ACTION:

Notice of deviation from drawbridge regulation.

SUMMARY:

The Coast Guard has issued a temporary deviation from the operating schedule that governs the University Bridge across the Lake Washington Ship Canal, mile 4.3, at Seattle, WA. The deviation is necessary to accommodate drawspan inspections. This deviation allows the bridge to operate in single leaf (half span) during inspections.

DATES:

This deviation is effective from 9 a.m. on August 9, 2017, to 3 p.m. on August 10, 2017.

ADDRESSES:

The docket for this deviation, USCG-2017-0721 is available at http://www.regulations.gov. Type the docket number in the “SEARCH” box and click “SEARCH.” Click on Open Docket Folder on the line associated with this deviation.

FOR FURTHER INFORMATION CONTACT:

If you have questions on this temporary deviation, call or email Mr. Danny McReynolds, Bridge Management Specialist, Thirteenth Coast Guard District; telephone 206-220-7234, email: [email protected]

SUPPLEMENTARY INFORMATION:

Seattle Department of Transportation, bridge owner, requested a temporary deviation from the operating schedule for the University Bridge across the Lake Washington Ship Canal, mile 4.3, at Seattle, WA, to allow safe inspections of each leaf of the double bascule drawspan. The University Bridge provides a vertical clearance of 30 feet in the closed-to-navigation position. Vertical clearances are referenced to the Mean Water Level of Lake Washington. While the bridge operates in single leaf (half span) mode, a horizontal clearance of 75 feet is provided. The normal operating schedule for the three subject bridge is in 33 CFR 117.1051. During this deviation period, the University Bridge is authorized to open half the drawspan to marine vessels from 9 a.m. on August 9, 2017, to 3 p.m. on August 9, 2017, and from 9 a.m. on August 10, 2017, to 3 p.m. on August 10, 2017.

Waterway usage on Lake Washington Ship Canal ranges from commercial tug and barge to small pleasure craft. Vessels able to pass under the bridge in the closed-to-navigation position may do so at anytime. The subject bridge will only be able to open the drawspan in single leaf for emergencies during this period, and there is no immediate alternate route for vessels to pass. The Coast Guard will also inform the users of the waterways through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge so that vessel operators can arrange their transits to minimize any impact caused by the temporary deviation.

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

Dated: July 31, 2017. Steven Michael Fischer, Bridge Administrator, Thirteenth Coast Guard District.
[FR Doc. 2017-16508 Filed 8-4-17; 8:45 am] BILLING CODE 9110-04-P
DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 117 [Docket No. USCG-2017-0732] Drawbridge Operation Regulation; Lake Washington Ship Canal, Seattle, WA AGENCY:

Coast Guard, DHS.

ACTION:

Notice of deviation from drawbridge regulation.

SUMMARY:

The Coast Guard has issued a temporary deviation from the operating schedule that governs the Montlake Bridge, across the Lake Washington Ship Canal, mile 5.2, at Seattle, WA. The deviation is necessary to accommodate vehicular traffic attending football games at Husky Stadium at the University of Washington, Seattle, WA. The deviation is necessary to allow the bridge to remain in the closed-to-navigation position two and a half hours before and two and a half hours after each game. The game times for five of the seven games scheduled for Husky Stadium have not yet been determined due to NCAA television scheduling.

DATES:

This deviation is effective from 2:30 p.m. on September 9, 2017 through 11 p.m. on November 25, 2017.

ADDRESSES:

The docket for this deviation, USCG-2017-0732 is available at http://www.regulations.gov. Type the docket number in the “SEARCH” box and click “SEARCH.” Click on Open Docket Folder on the line associated with this deviation.

FOR FURTHER INFORMATION CONTACT:

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

SUPPLEMENTARY INFORMATION:

The Washington State Department of Transportation (the bridge owner), on behalf of the University of Washington Police Department, has requested that the Montlake Bridge bascule span remain in the closed-to-navigation position, and need not open to vessel traffic to facilitate timely movement of pre-game and post game football traffic at Husky Stadium at the University of Washington, Seattle, WA. The Montlake Bridge crosses the Lake Washington Ship Canal at mile 5.2; and in the closed-to-navigation position provides 30 feet of vertical clearance throughout the navigation channel and 46 feet of vertical clearance throughout the center 60-feet of the bridge. These vertical clearances are made in reference to the Mean Water Level of Lake Washington. The normal operating schedule for Montlake Bridge operates in accordance with 33 CFR 117.1051(e).

The deviation period will cover the following dates:

Time/date start Time/date end Action 2:30 a.m. Sep 9, 2017 5 p.m. Sep 9, 2017 span in the closed-to-navigation position. 8:30 p.m. Sep 9, 2017 11 p.m. Sep 9, 2017 span in the closed-to-navigation position. 4 p.m. Sep 16, 2017 6:30 p.m. Sep 16, 2017 span in the closed-to-navigation position. 9:30 p.m. Sep 16, 2017 11:59 p.m. Sep 16, 2017 span in the closed-to-navigation position. TBA Oct 7, 2017 TBA Oct 7, 2017 span in the closed-to-navigation position. TBA Oct 28, 2017 TBA Oct 28, 2017 span in the closed-to-navigation position. TBA Nov 4, 2017 TBA Nov 4, 2017 span in the closed-to-navigation position. TBA Nov 18, 2017 TBA Nov 18, 2017 span in the closed-to-navigation position. TBA Nov 25, 2017 TBA Nov 25, 2017 span in the closed-to-navigation position.

The times for the closures on the dates with TBA (Time to Be Announced) will be determined, and announced in the Coast Guard's Local Notice to Mariners and Broadcast Notice to Mariners as they become available. Due to NCAA television scheduling, the times for the games are not currently available. The bridge shall operate in accordance to 33 CFR 117.1051(e) at all other times. Waterway usage on the Lake Washington Ship Canal ranges from commercial tug and barge to small pleasure craft. Vessels able to pass through the bridge in the closed-to-navigation position may do so at anytime. The bridge will be able to open for emergencies and there is no immediate alternate route for vessels to pass.

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

Dated: July 31, 2017. Steven Michael Fischer, Bridge Administrator, Thirteenth Coast Guard District.
[FR Doc. 2017-16502 Filed 8-4-17; 8:45 am] BILLING CODE 9110-04-P
DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket No. USCG-2017-0679] Safety Zone; North Atlantic Ocean, Ocean City, NJ AGENCY:

Coast Guard, DHS.

ACTION:

Notice of enforcement of regulation.

SUMMARY:

The Coast Guard will enforce the North Atlantic Ocean, Ocean City, NJ, safety zone from 9:00 p.m. through 11:59 p.m. on October 10, 2017. This action is necessary to ensure safety of life on the navigable waters of the United States immediately prior to, during, and immediately after a fireworks display event. During the enforcement period, and in accordance with the safety zone, no vessel or person may enter, transit through, anchor in, or remain within the regulated area unless authorized by the Captain of the Port Delaware Bay or a designated representative.

DATES:

The regulations in 33 CFR 165.506 will be enforced from 9:00 p.m. to 11:59 p.m. on October 10, 2017, for the safety zone listed as (a.)11 in the Table to § 165.506.

FOR FURTHER INFORMATION CONTACT:

If you have questions about this notice of enforcement, you may call or email MST2 Amanda Boone, Sector Delaware Bay Waterways Management Division, U.S. Coast Guard; telephone 215-271-4889, email [email protected]

SUPPLEMENTARY INFORMATION:

The Coast Guard will enforce the safety zone at 33 CFR 165.506, Table to § 165.506, (a.)11 for the regulated area located on the North Atlantic Ocean near Ocean City, NJ, from 9:00 p.m. to 11:59 p.m. on October 10, 2017. This action is necessary to ensure safety of life on U.S. navigable waterways during a fireworks display.

Coast Guard regulations for recurring fireworks displays within Captain of the Port Delaware Bay Zone appear in § 165.506, Safety Zones; Fireworks Displays in the Fifth Coast Guard District, which specifies the location for this regulated area as all waters of the North Atlantic Ocean within a 500 yard radius of the fireworks barge in approximate location latitude 39°16′22″ N., longitude 074°33′54″ W., in the vicinity of the shoreline at Ocean City, NJ.

As specified in §  165.506, during the enforcement period, no vessel or person may enter, transit through, anchor in, or remain within the regulated area unless authorized by the Captain of the Port Delaware Bay or a designated representative. If permission is granted, all persons and vessels shall comply with the instructions of the COTP, designated representative or Patrol Commander.

This notice of enforcement is issued under authority of 33 CFR 165.506 and 33 U.S.C. 1233. The Coast Guard will provide the maritime community with advanced notice of enforcement of regulation by Broadcast Notice to Mariners (BNM), Local Notice to Mariners and on-scene notice by a designated representative.

In the event the Captain of the Port, Delaware Bay determines that it's not necessary to enforce the regulated area for the entire duration of the enforcement period, a BNM will be issued to authorize general permission to enter the regulated area.

Dated: August 1, 2017. Scott E. Anderson, Captain, U.S. Coast Guard, Captain of the Port Delaware Bay.
[FR Doc. 2017-16506 Filed 8-4-17; 8:45 am] BILLING CODE 9110-04-P
ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 60 [EPA-HQ-OAR-2014-0292; FRL-9965-63-OAR] Revisions to Test Methods, Performance Specifications, and Testing Regulations for Air Emission Sources; Technical Correction AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Final rule; technical correction.

SUMMARY:

The Environmental Protection Agency (EPA) is taking action to correct an omission in revisions requested to Performance Specification 2 in the “revisions” rule published August 30, 2016.

DATES:

Effective: August 7, 2017.

FOR FURTHER INFORMATION CONTACT:

Mrs. Lula H. Melton, Air Quality Assessment Division, Office of Air Quality Planning and Standards (E143-02), Environmental Protection Agency, Research Triangle Park, NC 27711; telephone number: (919) 541-2910; fax number: (919) 541-0516; email address: [email protected].

SUPPLEMENTARY INFORMATION:

This action removes subparagraphs 6.1.1.1, 6.1.1.2, 6.1.1.3, and 6.1.1.4 in Performance Specification 2. These four subparagraphs are no longer necessary due to revisions that were made to paragraph 6.1.1 in the final “revisions” rule dated August 30, 2016 (81 FR 59800).

Section 553 of the Administrative Procedure Act (APA), 5 U.S.C. 553(b)(3)(B), provides that, when an agency for good cause finds that notice and public procedure are impracticable, unnecessary, or contrary to the public interest, the agency may issue a rule without providing notice and an opportunity for public comment. We have determined that there is good cause for making this technical amendment final without prior proposal and opportunity for public amendment because only simple publication errors are being corrected that do not substantially change the agency actions taken in the final rule. Thus, notice and public procedure are unnecessary. (See also the final sentence of section 307(d)(1) of the Clean Air Act (CAA), 42 U.S.C. 307(d)(1), indicating that the good cause provisions in subsection 553(b) of the APA continue to apply to this type of rulemaking under section 307(d) of the CAA.)

List of Subjects in 40 CFR Part 60

Environmental protection, Administrative practice and procedure, Air pollution control.

Dated: July 25, 2017. Sarah Dunham, Acting Assistant Administrator.

For the reasons stated in the preamble, the Environmental Protection Agency corrects title 40, chapter I of the Code of Federal Regulations as follows:

PART 60—STANDARDS OF PERFORMANCE FOR NEW STATIONARY SOURCES 1. The authority citation for part 60 continues to read as follows: Authority:

42 U.S.C. 7401 et. seq.

Appendix B to Part 60 [Corrected]
2. In appendix B to part 60, in “Performance Specification 2-Specifications and Test Procedures for SO2 and NOX Continuous Emission Monitoring Systems in Stationary Sources” remove sections 6.1.1.1, 6.1.1.2, 6.1.1.3, and 6.1.1.4.
[FR Doc. 2017-16493 Filed 8-4-17; 8:45 am] BILLING CODE 6560-50-P
DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 635 [Docket No. 150121066-5717-02] RIN 0648-XF577 Atlantic Highly Migratory Species; Atlantic Bluefin Tuna Fisheries AGENCY:

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

ACTION:

Temporary rule; inseason General category retention limit adjustment.

SUMMARY:

NMFS is adjusting the Atlantic bluefin tuna (BFT) General category daily retention limit from four large medium or giant BFT per vessel per day/trip to two large medium or giant BFT per vessel per day/trip for the remainder of the 2017 fishing year. This action is based on consideration of the regulatory determination criteria regarding inseason adjustments, and applies to Atlantic Tunas General category (commercial) permitted vessels and Highly Migratory Species (HMS) Charter/Headboat category permitted vessels when fishing commercially for BFT.

DATES:

Effective August 5, 2017, through December 31, 2017.

FOR FURTHER INFORMATION CONTACT:

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

SUPPLEMENTARY INFORMATION:

Regulations implemented under the authority of the Atlantic Tunas Convention Act (ATCA; 16 U.S.C. 971 et seq.) and the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act; 16 U.S.C. 1801 et seq.) governing the harvest of BFT by persons and vessels subject to U.S. jurisdiction are found at 50 CFR part 635. Section 635.27 subdivides the U.S. BFT quota recommended by the International Commission for the Conservation of Atlantic Tunas (ICCAT) among the various domestic fishing categories, per the allocations established in the 2006 Atlantic Consolidated Highly Migratory Species Fishery Management Plan (2006 Consolidated HMS FMP) (71 FR 58058, October 2, 2006), as amended by Amendment 7 to the 2006 Consolidated HMS FMP (Amendment 7) (79 FR 71510, December 2, 2014), and in accordance with implementing regulations. NMFS is required under ATCA and the Magnuson-Stevens Act to provide U.S. fishing vessels with a reasonable opportunity to harvest the ICCAT-recommended quota.

The base quota for the General category is 466.7 mt. See § 635.27(a). Each of the General category time periods (January, June through August, September, October through November, and December) is allocated a “subquota” or portion of the annual General category quota. Although it is called the “January” subquota, the regulations allow the General category fishery under this quota to continue until the subquota is reached or March 31, whichever comes first. The subquotas for each time period are as follows: 24.7 mt for January; 233.3 mt for June through August; 123.7 mt for September; 60.7 mt for October through November; and 24.3 mt for December. Any unused General category quota rolls forward within the fishing year, which coincides with the calendar year, from one time period to the next, and is available for use in subsequent time periods. On December 19, 2016, NMFS published an inseason action transferring 16.3 mt of BFT quota from the December 2017 subquota to the January 2017 subquota period (81 FR 91873). For 2017, NMFS also transferred 40 mt from the Reserve to the General category effective March 2, resulting in an adjusted General category quota of 506.7 mt (82 FR 12747, March 7, 2017).

Adjustment of General Category Daily Retention Limit

The default General category retention limit is one large medium or giant BFT (measuring 73 inches (185 cm) curved fork length (CFL) or greater) per vessel per day/trip (§ 635.23(a)(2)).

Thus far this year, NMFS adjusted the daily retention limit for the 2017 January subquota period from the default level of one large medium or giant BFT to three large medium (81 FR 91873, December 19, 2016). NMFS closed the January 2017 fishery on March 29 (82 FR 16136, April 3, 2017). NMFS adjusted the daily retention limit from the default level of one large medium or giant BFT to four large medium or giant BFT for the June through August 2017 subquota period (82 FR 22616, May 17, 2017).

Under § 635.23(a)(4), NMFS may increase or decrease the daily retention limit of large medium and giant BFT over a range of zero to a maximum of five per vessel based on consideration of the relevant criteria provided under § 635.27(a)(8). NMFS has considered the relevant regulatory determination criteria and their applicability to the General category BFT retention limit for the remainder of the June through August 2017 subquota time period. In addition, because NMFS normally prepares a Federal Register notice to adjust the daily retention limit for the remainder of the year in early August, NMFS simultaneously is taking action to adjust the retention limit for the September, October through November, and December subquota time periods from the default level that would otherwise take effect September 1, 2017. These considerations include, but are not limited to, the following:

NMFS considered the catches of the General category quota to date (including during the summer/fall and winter fisheries in the last several years), and the likelihood of closure of that segment of the fishery if no adjustment is made (§ 635.27(a)(8)(ii) and (ix)). Commercial-size BFT are currently readily available to vessels fishing under the General category quota. As of July 31, 2017, the General category has landed approximately 268.3 mt, which is 57 and 53 percent of the annual base and adjusted 2017 General category quotas, respectively. Landings since June 1, 2017, are 160.6 mt, representing 69 percent of the General category subquota for the June 1 through August 31 period. If current catch rates continue with the four-fish daily limit, the available subquota for June 1 through August 31 period could be reached or exceeded, and NMFS would need to close the fishery earlier than otherwise would be necessary under a lower limit.

Regarding the usefulness of information obtained from catches in the particular category for biological sampling and monitoring of the status of the stock (§ 635.27(a)(8)(i)), biological samples collected from BFT landed by General category fishermen and provided by BFT dealers continue to provide NMFS with valuable data for ongoing scientific studies of BFT age and growth, migration, and reproductive status. Prolonged opportunities to land BFT over the longest time-period allowable would support the collection of a broad range of data for these studies and for stock monitoring purposes.

NMFS also considered the effects of the adjustment on BFT rebuilding and overfishing and the effects of the adjustment on accomplishing the objectives of the FMP (§ 635.27(a)(8)(v) and (vi)). The adjusted retention limit would be consistent with the quotas established and analyzed in the BFT quota final rule (80 FR 52198, August 28, 2015), and with objectives of the 2006 Consolidated HMS FMP and amendments, and is not expected to negatively impact stock health or to affect the stock in ways not already analyzed in those documents. It is also important that NMFS limit landings to the subquotas both to adhere to the FMP quota allocations and to ensure that landings are as consistent as possible with the pattern of fishing mortality (e.g., fish caught at each age) that was assumed in the projections of stock rebuilding.

Another relevant criterion is the effects of catch rates in one area precluding vessels in another area from having a reasonable opportunity to harvest a portion of the category's quota (§ 635.27(a)(8)(viii)). NMFS anticipates that some underharvest of the 2016 adjusted U.S. BFT quota will be carried forward to 2017 to the Reserve category, in accordance with the regulations, later this summer when complete BFT catch information for 2016 is available and finalized. This increases the likelihood that General category quota will remain available through the end of 2017, provided retention limits are managed accordingly. Last fall, General category landings were relatively high due to a combination of fish availability, favorable fishing conditions, and higher daily retention limits (five fish per day for June 1 through October 8, four fish effective October 9 through October 16, and two fish effective October 17 through November 3). Given these conditions, NMFS transferred 125 mt from the Reserve category (81 FR 70369, October 12, 2016) and later transferred another 85 mt (18 mt from the Harpoon category and 67 mt from the Reserve category) (81 FR 71639, October 18, 2016). Nevertheless, NMFS had to close the 2016 General category fishery effective November 4 to prevent further overharvest of the adjusted General category quota. For 2017, NMFS again intends to provide General category participants in all areas and time periods opportunities to harvest the General category quota without exceeding it, through active inseason management such as retention limit adjustments and/or the timing and amount of quota transfers (based on consideration of the determination criteria regarding inseason adjustments), while extending the season as long as practicable.

Another principal consideration in setting the retention limit is the objective of providing opportunities to harvest the full General category quota without exceeding it based on the goals of the 2006 Consolidated HMS FMP and amendments, including to achieve optimum yield on a continuing basis and to optimize the ability of all permit categories to harvest their full BFT quota allocations (related to § 635.27(a)(8)(x)).

Based on these considerations, NMFS has determined that a two-fish General category retention limit is warranted for the remainder of the year. It would provide a reasonable opportunity to harvest the U.S. quota of BFT without exceeding it, while maintaining an equitable distribution of fishing opportunities, help optimize the ability of the General category to harvest its available quota, allow collection of a broad range of data for stock monitoring purposes, and be consistent with the objectives of the 2006 Consolidated HMS FMP and amendments. Therefore, NMFS adjusts the General category retention limit from four to two large medium or giant BFT per vessel per day/trip, effective August 5, 2017, through December 31, 2017. Depending on the level of fishing effort and catch rates of BFT, NMFS may determine that additional adjustments are necessary to ensure available quota is not exceeded or to enhance scientific data collection from, and fishing opportunities in, all geographic areas.

Regardless of the duration of a fishing trip, no more than a single day's retention limit may be possessed, retained, or landed. For example (and specific to the limit that will apply through the end of the year), whether a vessel fishing under the General category limit takes a two-day trip or makes two trips in one day, the daily limit of two fish may not be exceeded upon landing. This General category retention limit is effective in all areas, except for the Gulf of Mexico, where NMFS prohibits targeting fishing for BFT, and applies to those vessels permitted in the General category, as well as to those HMS Charter/Headboat permitted vessels fishing commercially for BFT.

Monitoring and Reporting

NMFS will continue to monitor the BFT fishery closely. Dealers are required to submit landing reports within 24 hours of a dealer receiving BFT. General and HMS Charter/Headboat vessel owners are required to report the catch of all BFT retained or discarded dead, within 24 hours of the landing(s) or end of each trip, by accessing hmspermits.noaa.gov or by using the HMS Catch Reporting App. If needed, subsequent adjustments will be published in the Federal Register. In addition, fishermen may call the Atlantic Tunas Information Line at (978) 281-9260, or access hmspermits.noaa.gov, for updates on quota monitoring and inseason adjustments.

Classification

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

Prior notice and an opportunity for public comment is impracticable because the regulations implementing the 2006 Consolidated HMS FMP, as amended, intended that inseason retention limit adjustments would allow the agency to respond quickly to the unpredictable nature of BFT availability on the fishing grounds, the migratory nature of this species, and the regional variations in the BFT fishery. Based on available BFT quotas, fishery performance in recent years, and the availability of BFT on the fishing grounds, adjustment to the General category BFT daily retention limit from the default level is warranted.

Delays in adjusting the retention limit may result in the available June 1 through August 31 subquota being reached or exceeded and NMFS needing to close the fishery earlier than otherwise would be necessary under the lower limit being set for this period. Such delays could adversely affect those General and HMS Charter/Headboat category vessels that would otherwise have an opportunity to harvest BFT if the fishery were to remain open for the duration of the subquota period. Limited opportunities to harvest the respective quotas may have negative social and economic impacts for U.S. fishermen that depend upon catching the available quota within the time periods designated in the 2006 Consolidated HMS FMP, as amended. Adjustment of the retention limit needs to be effective as soon as possible to extend fishing opportunities for fishermen in geographic areas with access to the fishery only during this time period.

Prior notice and an opportunity for public comment is also impracticable for the retention limit adjustment to two-fish for the September-December subquota periods. By adopting the two-fish limit for the remainder of the year through this action, NMFS avoids confusion that would arise for the regulated community from two inseason actions adopting the same limit. Delaying implementation of the two-fish retention limit for the September-December subquota periods could also result in temporary reversion to a one-fish limit under the default regulatory provisions, which would further confuse the regulated community. Avoiding delay in implementation will also allow fishermen to take advantage of the availability of fish on the fishing grounds and of quota. Therefore, the AA finds good cause under 5 U.S.C. 553(b)(B) to waive prior notice and the opportunity for public comment. For these reasons, there is good cause under 5 U.S.C. 553(d) to waive the 30-day delay in effectiveness.

This action is being taken under §§ 635.23(a)(4) and 635.27(a)(9), and is exempt from review under Executive Order 12866.

Authority:

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

Dated: August 2, 2017. Alan D. Risenhoover, Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
[FR Doc. 2017-16583 Filed 8-2-17; 4:15 pm] BILLING CODE 3510-22-P
82 150 Monday, August 7, 2017 Proposed Rules DEPARTMENT OF THE TREASURY Office of the Comptroller of the Currency 12 CFR Part 44 [Docket ID OCC-2017-0014] Proprietary Trading and Certain Interests in and Relationships With Covered Funds (Volcker Rule); Request for Public Input AGENCY:

Office of the Comptroller of the Currency (OCC), Treasury.

ACTION:

Request for information.

SUMMARY:

The OCC is seeking the public's input with this request for information to assist in determining how the final rule implementing section 13 of the Bank Holding Company Act (commonly referred to as the “Volcker Rule”) should be revised to better accomplish the purposes of the statute. The OCC also solicits comments suggesting improvements in the ways in which the final rule has been applied and administered to date. This OCC request is limited to regulatory actions that may be undertaken to achieve these objectives. The OCC is not requesting comment on changes to the underlying Volcker statute. The OCC recognizes that any revision to the final rule or the administration of that rule must be done consistent with the constraints of the statute and requests that commenters provide input that fits within the contours of that structure.

DATES:

Comments should be submitted by September 21, 2017.

ADDRESSES:

You may submit comments to the OCC by any of the methods set forth below. Because paper mail in the Washington, DC area and at the OCC is subject to delay, commenters are encouraged to submit comments through the Federal eRulemaking Portal or email, if possible. Please use the title “Volcker Rule; Request for Information” to facilitate the organization and distribution of the comments. You may submit comments by any of the following methods:

Federal eRulemaking Portal—“Regulations.gov”: Go to www.regulations.gov. Enter “Docket ID OCC-2017-0014” in the Search Box and click “Search.” Click on “Comment Now” to submit public comments.

• Click on the “Help” tab on the Regulations.gov home page to get information on using Regulations.gov, including instructions for submitting public comments.

Email: [email protected]

Mail: Legislative and Regulatory Activities Division, Office of the Comptroller of the Currency, 400 7th Street SW., Suite 3E-218, Washington, DC 20219.

Hand Delivery/Courier: 400 7th Street SW., Suite 3E-218, Washington, DC 20219.

Fax: (571) 465-4326.

Instructions: You must include “OCC” as the agency name and “Docket ID OCC-2017-0014” in your comment. In general, the OCC will enter all comments received into the docket and publish them on the Regulations.gov Web site without change, including any business or personal information that you provide such as name and address information, email addresses, or phone numbers. Comments received, including attachments and other supporting materials, are part of the public record and subject to public disclosure. Do not include any information in your comment or supporting materials that you consider confidential or inappropriate for public disclosure.

You may review comments and other related materials that pertain to this request for information by any of the following methods:

Viewing Comments Electronically: Go to www.regulations.gov. Enter “Docket ID OCC-2017-0014” in the Search box and click “Search.” Click on “Open Docket Folder” on the right side of the screen. Comments and supporting materials can be filtered by clicking on “View all documents and comments in this docket” and then using the filtering tools on the left side of the screen.

• Click on the “Help” tab on the Regulations.gov home page to get information on using Regulations.gov. The docket may be viewed after the close of the comment period in the same manner as during the comment period.

Viewing Comments Personally: You may personally inspect and photocopy comments at the OCC, 400 7th Street SW., Washington, DC. For security reasons, the OCC requires that visitors make an appointment to inspect comments. You may do so by calling (202) 649-6700 or, for persons who are deaf or hard of hearing, TTY, (202) 649-5597. Upon arrival, visitors will be required to present valid government-issued photo identification and submit to security screening in order to inspect and photocopy comments.

FOR FURTHER INFORMATION CONTACT:

Ted Dowd, Director; Suzette Greco, Assistant Director; Tabitha Edgens, Senior Attorney; Mark O'Horo, Attorney, Securities and Corporate Practices Division, (202) 649-5510; Patrick Tierney, Assistant Director, Legislative and Regulatory Activities Division, (202) 649-5490, 400 7th Street SW., Washington, DC 20219.

SUPPLEMENTARY INFORMATION:

The OCC gives notice that it is seeking the public's input to assist in determining how the final rule implementing section 13 of the Bank Holding Company Act 1 (the “final rule”) should be revised to better accomplish the purposes of the statute. The OCC also solicits comments suggesting improvements in the ways the final rule has been applied and administered to date. The request for information published here also is available on the OCC's Web site.

1 12 CFR part 44 (OCC); 12 CFR part 248 (Board); 12 CFR part 351 (FDIC); 17 CFR part 75 (CFTC); 17 CFR part 255 (SEC).

As this request for information describes, there is broad recognition that the final rule should be improved both in design and in application. A report recently issued by the Department of the Treasury 2 (“Treasury Report”) identifies problems with the design of the final rule—the inclusion of a “purpose” test for defining proprietary trading, for example. The report also contains recommendations for revisions to the final rule. The OCC's objective in issuing this request for information is to gather additional, more specific information that could provide focused support for any reconsideration of the final rule that the rulewriting agencies may undertake and contribute to the development of the bases for particular changes that may be proposed.

2 U.S. Department of the Treasury Report, A Financial System that Creates Economic Opportunities: Banks and Credit Unions (2017), pp. 71-78, 132-133.

The information that the OCC is soliciting could support the revisions to the final rule advanced in the Treasury Report and elsewhere; it also may support additional revisions that are consistent with the spirit of the Treasury Report. In any case, the OCC and the other Volcker rulewriting agencies will need to explain the basis for any changes to the current rule that may be proposed. The OCC recognizes that revisions to the current rule must be undertaken jointly by the OCC, the Board of Governors of the Federal Reserve System, and the Federal Deposit Insurance Corporation and in consultation and coordination with the Securities and Exchange Commission and the Commodity Futures Trading Commission. The OCC anticipates that the information solicited here—that is, information and data describing with specificity any burdens or inefficiencies resulting from the current rule and explaining how particular revisions would alleviate those burdens or inefficiencies—would be useful to inform the drafting of a proposed rule.

Seeking Public Input on the Volcker Rule I. Background

Section 619 of the Dodd-Frank Wall Street Reform and Consumer Protection Act (“Dodd-Frank Act”) created a new section 13 of the Bank Holding Company Act (“BHC Act”), which generally prohibits “banking entities” (e.g., insured depository institutions, companies that control an insured depository institution, and their affiliates and subsidiaries) from engaging in proprietary trading and from holding an ownership interest in, sponsoring, or having certain relationships with hedge fund and private equity funds.3 Section 13 of the BHC Act authorized the Office of the Comptroller of the Currency (“OCC”), Board of Governors of the Federal Reserve System (the “Board”), Federal Deposit Insurance Corporation (“FDIC”), Commodity Futures Trading Commission (“CFTC”), and Securities and Exchange Commission (“SEC”) (together, the “Agencies”) to issue implementing regulations.4 The Agencies issued final regulations implementing section 13 in December 2013, with an effective date of April 1, 2014.5 Banking entities were generally required to conform their proprietary trading activities and investments to the requirements of section 13 and the final rule (together, the “Volcker Rule”) by July 21, 2015.6

3See 12 U.S.C. 1851.

4 The federal banking agencies (i.e., the OCC, the Board, and the FDIC) must act jointly to issue final regulations with respect to insured depository institutions. 12 U.S.C. 1851(b)(2)(B)(i)(I). The five Agencies, in developing and issuing final rules, must consult and coordinate with each other, as appropriate, for the purposes of assuring, to the extent possible, that such rules are comparable and provide for consistent application and implementation of the applicable provisions of Section 13. 12 U.S.C. 1851(b)(2)(B)(ii).

5 12 CFR part 44 (OCC); 12 CFR part 248 (Board); 12 CFR part 351 (FDIC); 17 CFR part 75 (CFTC); 17 CFR part 255 (SEC).

6See Board Order Approving Extension of Conformance Period (Dec. 31, 2014). The Board also granted two additional one-year extensions (until July 21, 2017) for “legacy” covered funds (i.e., covered fund relationships and investments that were in place prior to December 31, 2013). See Board Order Approving Extension of Conformance Period Under Section 13 of the Bank Holding Company Act (Dec. 18, 2014); Board Order Approving Extension of Conformance Period Under Section 13 of the Bank Holding Company Act (July 6, 2016). In 2017, the Board approved banking entity applications for additional transition periods of up to five years for specified legacy “illiquid funds.”

The final rule's proprietary trading provisions generally prohibit banking entities from engaging, as principal, in short-term trading of certain securities, derivatives, commodity futures and options on these instruments.7 The final rule's covered funds provisions generally prohibit banking entities from acquiring or retaining an ownership interest in, sponsoring, or having certain relationships with a hedge fund or private equity fund (“covered fund”). The final rule defines the term covered fund to include any issuer that would be an investment company under the Investment Company Act of 1940 if it were not otherwise excluded by sections 3(c)(1) or 3(c)(7) of that Act, as well as certain foreign funds and commodity pools.8 The proprietary trading prohibition and the covered funds prohibition are subject to a number of exclusions and exemptions. Banking entities of all sizes are subject to the Volcker Rule and are generally required to establish an internal compliance program reasonably designed to ensure and monitor compliance with the Volcker Rule.9

7See 12 CFR part 44, subpart B.

8See 12 CFR part 44, subpart C.

9See 12 CFR part 44, subpart D. See section titled “Compliance Program and Metrics Reporting Requirements” below for additional background on the Volcker Rule compliance program requirements.

The Volcker Rule was intended to promote the safety and soundness of banking entities and prevent taxpayer bailouts by minimizing bank exposure to certain proprietary trading and fund activities that could involve undue risk. At the same time, the Volcker Rule was designed to permit banking entities to continue providing client-oriented financial services that are critical to capital generation and that facilitate liquid markets.10 Some have asserted that the Volcker Rule has succeeded in accomplishing these goals in some respects.11 However, others have identified difficulties in interpreting and applying some of the final rule's provisions.12 Many have argued that the final rule is overly complex and vague.13 Banking entities in particular have suggested that, despite their best efforts, they sometimes are not able to distinguish permissible from prohibited activities.14 Banking entities also have suggested that the Volcker Rule is overbroad and restricts a number of essential financial functions, potentially restricting activities that could spur economic growth. In particular, firms have suggested that they have been forced to curtail economically useful market-making, hedging, and asset-liability management to avoid violating the proprietary trading prohibition. 15 The covered funds prohibition has also been criticized for capturing investment vehicles that facilitate lending activity and capital formation, even though they may not be equivalent to traditional private equity funds or hedge funds.16

10See 79 FR 5535, 5541.

11See, e.g., Marc Jarsulic, Vice President, Economic Policy, Center for American Progress, Testimony before the House Committee on Financial Services, Subcommittee on Capital Markets, Securities, and Investment, U.S. House of Representatives (Mar. 29, 2017), (arguing the Volcker Rule has caused banks to exit proprietary trading activities but has not caused a significant impact on corporate bond market liquidity).

12See, e.g., Daniel K. Tarullo, Governor of the Federal Reserve System, Departing Thoughts at the Woodrow Wilson School, Princeton University (April 4, 2017) (“Departing Thoughts”); William C. Dudley, President and Chief Executive Officer of the Federal Reserve Bank of New York, Remarks at the Princeton Club of New York (April 7, 2017) (“Princeton Club”); Examining the Impact of the Volcker Rule on the Markets, Businesses, Investors, and Job Creators: Hearing on the Volcker Rule Before the Subcomm. On Capital Markets, Securities, and Investment of the House Comm. On Financial Services, 115th Cong. (2017); American Bankers Association, The Volcker Rule: Islands of Permission in a Sea of Prohibition (2017); Institute of International Bankers, U.S. Supervision and Regulation of International Banks: Recommendations for the Report of the Treasury Secretary (2017); Financial Services Roundtable, FSR Recommendations for Aligning Financial Regulation With Core Principles (2017); The Clearing House, Submission to the U.S. Treasury Department: Aligning the U.S. Bank Regulatory Framework with the Core Principles of Financial Regulation (2017).

13See, e.g., U.S. Department of the Treasury Report, A Financial System that Creates Economic Opportunities: Banks and Credit Unions (2017) (“The rule has spawned an extraordinarily complex and burdensome compliance regime due to a combination of factors . . .”); Tarullo, Departing Thoughts; American Bankers Association.

14See, e.g., American Bankers Association (“. . . in many cases, a bank may not know whether it is engaged in impermissible activities until it is notified in the course of a bank examination.”).

15See, e.g., American Bankers Association (“The goal should be to provide certainty that the rules will not impede banks from engaging in bona fide market-making, asset liability management, hedging, and other trading activities. . . .”); Financial Services Roundtable (“For example, the bank issues public debt for funding purposes and then swaps the payments to fixed for floating through a plain-vanilla interest-rate swap in order to meet its asset-liability management objectives. Again, this is not an activity, that we believe the architects of the Volcker Rule envisioned including within the Rule's restrictions, but resident examiners and their legal departments have interpreted it as such.”).

16See, e.g., Institute of International Bankers (“The Agencies' approach has therefore resulted in an overly broad definition of covered fund that goes well beyond the original intent to capture private equity funds and hedge funds, and the list of enumerated exclusions fails to exclude many vehicles that are not equivalent to traditional private equity funds or hedge funds.”); Financial Services Roundtable (“This approach, however, remains overly broad. For example, it captures funds that invest solely in funds that are otherwise excluded funds, some plain-vanilla securitizations, and re-REMICs.”).

The OCC is seeking the public's input on whether aspects of the final rule and its implementation should be revised to better accomplish the purposes of section 13 of the BHC Act while decreasing the compliance burden on banking entities and fostering economic growth. In particular, the OCC is inviting input on ways to tailor further the rule's requirements and clarify key provisions that define prohibited and permissible activities. The OCC is also inviting input on how the existing rule could be implemented more effectively without revising the regulation. The OCC encourages the public to submit data addressing the effectiveness of the rule and its implementation, the current compliance burden, and any need for additional guidance and/or proposed revisions to the rule.

The OCC recognizes that any revisions to the final rule would need to be undertaken together with the other Agencies. Revisions would require the Agencies to articulate a reasoned basis for the changes, so it is especially important for those commenting to provide evidence demonstrating the nature and scope of the problems they identify and the likely efficacy of any solutions they propose. The OCC believes the information gathered in response to this request for information would be helpful in that regard.

This request for information identifies four broad areas for the public's consideration: (1) The scope of entities to which the final rule applies; (2) the proprietary trading restrictions; (3) the covered fund restrictions; and (4) the compliance program and metrics reporting requirements. However, the OCC is inviting comments on all aspects of the final rule and its administration. The request for information is limited to regulatory actions that may be undertaken to better accomplish the purpose of the statute and improve the way the final rule has been applied and administered to date. The OCC is not requesting comment on changes to the underlying Volcker statute. Regulatory actions that may be undertaken to achieve these objectives will be subject to the constraints of the statute. For instance, activity the Agencies may permit under the market-making or risk mitigating hedging exceptions to the general proprietary trading prohibition are subject to statutory safety and soundness and financial stability backstops, as well as other conditions.

II. Topics and Questions

The OCC is particularly interested in receiving comments and supporting data on the following topics and questions: 17

17 For purposes of this information request, “data” includes both quantitative and qualitative information, as well as other verifiable evidence supporting respondents' comments and suggestions.

Scope of Entities Subject to the Rule

The Volcker Rule's statutory prohibition applies to any “banking entity,” 18 a term that is defined to include any insured depository institution, any company that controls an insured depository institution, or that is treated as a bank holding company for purposes of section 8 of the International Banking Act of 1978, and any affiliate or subsidiary of such entity.19 The Agencies adopted this definition in the final rule and provided a limited number of specific exclusions.20

18 12 U.S.C. 1851(a)(1).

19 12 U.S.C. 1851(h)(1).

20 The final rule excludes from the definition of “banking entity” (i) a covered fund that does not itself meet the definition of banking entity, (ii) a portfolio company held under the authority of section 4(k)(4)(H) or (I) of the BHC Act or any portfolio concern defined under 13 CFR 107.50 that is controlled by a small business investment company, and (iii) the FDIC acting in its corporate capacity or as a conservator or receiver under the Federal Deposit Insurance Act or Title II of the Dodd-Frank Act. 12 CFR 44.2(c).

As a result of this definition, the Volcker Rule prohibitions and compliance program requirements apply to many entities that may not pose systemic risk concerns, such as small community banks engaged primarily in traditional banking activities and other banks that do not engage in the type of activities, or in activities that present the type of risk, that the Volcker Rule was designed to restrict. For example, banks with minimal or no proprietary trading activities are subject to the final rule. Many of these institutions have reported experiencing a significant regulatory burden. The final rule's tailored compliance program requirements were intended to reduce the Volcker Rule's economic impact on small banking entities,21 but even determining whether an entity is eligible for the simplified program can pose a significant burden for small banks.22 In addition, certain activities of small banks have been caught up in the proprietary trading prohibition. Exempting small banking entities and other banking entities without substantial trading activities would enable them to reduce their compliance costs and devote more resources to local lending without materially increasing risk to the financial system.23

21 The OCC, Board, and FDIC statement on the Volcker Rule's applicability to community banks, released concurrently with the final rule, recognized that “the vast majority of these community banks have little or no involvement in prohibited proprietary trading or investment activities in covered funds. Accordingly, community banks do not have any compliance obligations under the final rule if they do not engage in any covered activities other than trading in certain government, agency, State or municipal obligations.” Board, FDIC, and OCC, The Volcker Rule: Community Bank Applicability (Dec. 10, 2013).

22 Toney Bland, Senior Deputy Comptroller for Midsize and Community Bank Supervision, OCC, Testimony before the House Committee on Financial Services, Subcommittee on Financial Institutions and Consumer Credit (Apr. 23, 2015), (“[C]ommunity banks need to ascertain whether their activities are covered by the Volcker Rule in order to understand whether they have any compliance obligations. Making this determination may require them to expend money and resources—for example, by hiring attorneys and consultants. This regulatory burden is not justified by the risk these institutions present.”). See also, Tarullo, Departing Thoughts.

23 Acting Comptroller of the Currency Keith Noreika, Testimony before the Senate Banking Committee (Jun. 22, 2017) (“Applying the Rule to community banks engaged primarily in traditional banking activities or to institutions that are not materially engaged in risky trading activities does not further the statutory purpose. Exempting community banks and providing an off-ramp for larger institutions depending on the nature and scope of their trading activities would reduce complexity, cost, and burden associated with the Volcker Rule by providing a tailored approach to addressing the risks the Rule was designed to contain.”). See also, Dudley, Princeton Club (“For smaller institutions, the regulatory and compliance burdens can be considerably lighter because the failure of such a firm will not impose large costs or stress on the broader financial system. Also, we must recognize that smaller firms have less ability to spread added compliance costs across their business. All else equal, an increase in compliance burden can create an unintended competitive advantage for larger institutions. We should also recognize the important role that smaller banking institutions have in supporting local communities around the country.”).

The banking entity definition also extends to foreign subsidiaries of foreign banking organizations acting outside of the United States. In particular, foreign banking organizations have raised questions regarding non-U.S. entities that are not covered funds under section 10(b)(iii) of the final rule (“foreign excluded funds”) and whether such funds may become banking entities if they are “controlled” by a banking entity.24 Foreign banking entities that sponsor foreign non-covered funds in some foreign jurisdictions may, by virtue of typical corporate governance structures for funds in these jurisdictions, be deemed to “control” a foreign non-covered fund for purposes of the BHC Act.25 These corporate governance structures have raised questions regarding whether foreign non-covered funds that are sponsored by foreign banking entities and offered solely outside the U.S. and in accordance with foreign laws are banking entities under the final rule. The OCC, Board, and FDIC, in consultation with the SEC and CFTC, issued a statement of policy on July 21, 2017, announcing that the three Federal banking agencies are coordinating review of the treatment of these funds under the final rule and providing that they would not propose to take action with respect to such foreign funds during the one-year period prior to July 21, 2018, if they meet the criteria specified in the statement of policy.

24See Board, FDIC, and OCC, Statement regarding Treatment of Certain Foreign Funds under the Rules Implementing Section 13 of the Bank Holding Company Act (July 21, 2017); Board, CFTC, FDIC, OCC, and SEC, Joint Release, Federal Regulatory Agencies Announce Coordination of Reviews for Certain Foreign Funds under “Volcker Rule” (July 21, 2017).

25 For example, sponsors of foreign funds in some foreign jurisdictions may select the majority of the fund's directors or trustees, or otherwise control the fund for purposes of the BHC Act by contract or through a controlled corporate director.

Questions on Scope of Entities Subject to the Rule

1. What evidence is there that the scope of the final rule is too broad?

2. How could the final rule be revised to appropriately narrow its scope of application and reduce any unnecessary compliance burden? What criteria could be used to determine the types of entities or activities that should be excluded? Please provide supporting data or other appropriate information.

3. How would an exemption for the activities of these banking entities be consistent with the purposes of the Volcker Rule and not compromise safety and soundness and financial stability? Please include supporting data or other appropriate information.

4. How could the rule provide a carve-out from the banking entity definition for certain controlled foreign excluded funds? How could the rule be tailored further to focus on activities with a U.S. nexus?

5. Are there other issues related to the scope of the final rule's application that could be addressed by regulatory action?

Proprietary Trading Prohibition

The final rule, like the statute, defines proprietary trading as engaging as principal for the trading account of the banking entity in any purchase or sale of one or more financial instruments. Building upon the statutory definition,26 the final rule adopted a three pronged definition of “trading account.” The first prong includes within the definition any account used by a banking entity to purchase or sell one or more financial instruments principally for the purpose of (a) short-term resale, (b) benefitting from short-term price movements, (c) realizing short-term arbitrage profits or (d) hedging any of the foregoing.27 Banking entities and commentators have asserted that this prong of the definition imposes a significant compliance burden because it requires determining the intent associated with each trade.

26 12 U.S.C. 1851(h)(6) (defining “trading account”).

27 12 CFR 44.3(b)(1)(i). The other two prongs of the trading account definition are the “market risk capital prong,” which applies to the purchase or sale of financial instruments that are both market risk capital rule covered positions and trading positions, and the “dealer prong,” which applies to the purchase or sale of financial instruments by a banking entity that is licensed or registered, or required to be licensed or registered, as a dealer, swap dealer, or security-based swap dealer, to the extent the instrument is purchased or sold in connection with the activities that require the banking entity to be licensed or registered as such. 12 CFR 44.3(b)(1)(ii) and (iii).

In addition, the final rule provides that the purchase or sale of a financial instrument will be presumed to be for the trading account under the first prong of the trading account definition if the banking entity holds the financial instrument for fewer than 60 days or substantially transfers the risk of the position within 60 days.28 If a banking entity sells or transfers the risk of a position within 60 days, it must be able to demonstrate that it did not purchase or sell the instrument for short-term trading purposes. Some banking entities have said that many transactions are presumed to be proprietary trading as a result of this provision, including transactions that were not the intended target of the proprietary trading restriction.

28 12 CFR 44.3(b)(2).

The Volcker statute and the final rule provide several exclusions and exemptions from the proprietary trading prohibition.29 However, banking entities have reported that complying with these exclusions and exemptions is unduly burdensome and the final rule's requirements may result in banking entities underutilizing them. In particular, industry groups, members of Congress, and others have argued that the rule does not provide sufficient latitude for banking entities to engage in market-making, which they have argued may have a negative impact on some measures of market liquidity.30

29 12 U.S.C. 1851(d); 12 CFR 44.3(d), 44.4, 44.5, 44.6.

30See, e.g., Thomas Quaadman, Executive Vice President, Center for Capital Markets Competitiveness, U.S. Chamber of Commerce, Statement to House Committee on Financial Services, Subcommittee on Capital Markets, Securities, and Investment, U.S. House of Representatives (Mar. 29, 2017) (“It is very difficult to distinguish between market making and proprietary trading without arbitrarily imposing a demarcation. The Volcker Rule significantly constrains their ability by dictating how banks should manage their inventory. This will reduce the depth and liquidity of our capital markets.”); Tarullo, Departing Thoughts (“Achieving compliance under the current approach would consume too many supervisory, as well as bank, resources relative to the implementation and oversight of other prudential standards. And although the evidence is still more anecdotal than systematic, it may be having a deleterious effect on market making, particularly for some less liquid issues.”).

Questions on the Proprietary Trading Prohibition

1. What evidence is there that the proprietary trading prohibition has been effective or ineffective in limiting banking entities' risk-taking and reducing the likelihood of taxpayer bailouts? What evidence is there that the proprietary trading prohibition does or does not have a negative impact on market liquidity?

2. What type of objective factors could be used to define proprietary trading?

3. Should the rebuttable presumption provision be revised, whether by elimination, narrowing, or introduction of a reverse presumption that presumes activities are not proprietary trading? Are there activities for which rebuttal should not be available? Should rebuttal be available for specified categories of activity? Could the rebuttable presumption provision be implemented in a way that decreases the compliance burden for banking entities?

4. What additional activities, if any, should be permitted under the proprietary trading provisions? Please provide a description of the activity and discuss why it would be appropriate to permit the activity, including supporting data or other appropriate information.

5. How could the existing exclusions and exemptions from the proprietary trading prohibition—including the requirements for permissible market-making and risk mitigating hedging activities—be streamlined and simplified? For example, does the distinction between “market-maker inventory” and “financial exposure” help ensure that trading desks using the market-making exemption are providing liquidity or otherwise functioning as market makers?

6. How could additional guidance or adjusted implementation of the existing proprietary trading provisions help to distinguish more clearly between permissible and impermissible activities?

7. Are there any other issues related to the proprietary trading prohibition that should be addressed by regulatory action?

Covered Funds Prohibition

Section 13 of the BHC Act generally prohibits banking entities from acquiring or holding an ownership in or sponsoring any private equity fund or hedge fund.31 Section 13 defines a hedge fund or private equity fund as an issuer that would be an investment company, as defined in the Investment Company Act of 1940 but for section 3(c)(1) or 3(c)(7) of that Act, or such similar funds as the Agencies may, by rule, determine. The Agencies adopted the definition referencing sections 3(c)(1) and 3(c)(7) of the Investment Company Act in the final rule and also included certain commodity pools and foreign funds in the covered fund definition.32 Recognizing that this definition may apply more broadly than necessary to achieve the Volcker Rule's purposes, the Agencies excluded several categories of issuers from the definition of covered fund in the final rule and established requirements for certain permitted covered fund activities, such as organizing and offering a covered fund,33 market making in covered fund interests,34 and covered fund activities and investments outside of the United States.35 Some have suggested that, notwithstanding the exclusions currently provided, the statutory definition referencing sections 3(c)(1) and 3(c)(7) of the Investment Company Act continues to include within its scope many issuers that were not intended to be covered by section 13.36

31 12 U.S.C. 1851(a)(1)(B).

32 12 CFR 44.10(b)(1)(ii) and (iii).

33 12 CFR 44.11(a).

34 12 CFR 44.11(c).

35 12 CFR 44.13(b).

36See American Bankers Association (“[T]he Volcker Rule regulations should apply only to those hedge funds and private equity funds that engage primarily in proprietary trading for near-term investment gains, thereby excluding funds (such as venture capital funds) . . . that do not raise the risks the Volcker Rule is intended to address.”); The Clearing House (“While the Agencies must implement the statute as Congress has enacted it, they have extended its reach to numerous other types of funds that bear little in relation to either private equity or hedge funds.”).

The final rule also implements section 13's restrictions on relationships with hedge funds and private equity funds.37 The so-called “Super 23A” provision prohibits a banking entity that serves as investment manager, adviser, or sponsor to a covered fund from entering into a transaction with the covered fund (or any other covered fund controlled by the covered fund) if the transaction would be a covered transaction as defined in section 23A of the Federal Reserve Act.38

37 12 U.S.C. 1851(f).

38 12 U.S.C. 371c; 12 CFR 44.14; 12 CFR part 223.

Questions on the Covered Funds Prohibition

1. What evidence is there that the final rule has been effective or ineffective in limiting banking entity exposure to private equity funds and hedge funds? What evidence is there that the covered fund definition is too broad in practice?

2. Would replacing the current covered fund definition that references sections 3(c)(1) and 3(c)(7) of the Investment Company Act of 1940 with a definition that references characteristics of the fund, such as investment strategy, fee structure, etc., reduce the compliance burden associated with the covered fund provisions? If so, what specific characteristics could be used to narrow the covered fund definition? Does data or other appropriate information support the use of a characteristics-based approach to fund investments?

3. What types of additional activities and investments, if any, should be permitted or excluded under the covered funds provisions? Please provide a description of the activity or investment and discuss why it would be appropriate to permit the activity or investment, including supporting data or other appropriate information.

4. Is section 14 of the final rule (the “Super 23A” provision) effective at limiting bank exposure to covered funds? Are there additional categories of transactions and relationships that should be permitted under this section?

5. How could additional guidance or adjusted implementation of the existing covered fund provisions help to distinguish more clearly between permissible and impermissible activities? For example, should the final rule be revised to clarify how the definition of “ownership interest” applies to securitizations?

6. Are there any other issues related to the covered funds prohibition that could be addressed by regulatory action?

Compliance Program and Metrics Reporting Requirements

The final rule adopted a tiered compliance program requirement based on the size, complexity, and type of activity conducted by each banking entity. Banking entities that do not engage in activities covered by the final rule other than trading in government obligations are not required to establish a compliance program unless they become engaged in covered activities.39 Banking entities with assets of $10 billion or less are eligible for a simplified compliance program.40 Nonetheless, banking entities have reported that the compliance program requirements in the final rule present a compliance burden, especially for small institutions that are not engaged in significant levels of proprietary trading and covered fund activities. Section 20 and Appendix A of the final rule require certain of the largest banking entities engaged in significant trading activities to collect, evaluate, and furnish data regarding covered trading activities as an indicator of areas meriting additional attention by the banking entity and relevant Agency.41

39 12 CFR 44.20(f)(1).

40 12 CFR 44.20(f)(2).

41 79 FR 5535, 5540.

Questions on the Compliance Program, Metrics Reporting Requirements, and Additional Issues

1. What evidence is there that the compliance program and metrics reporting requirements have facilitated banking entity compliance with the substantive provisions of the Volcker Rule? What evidence is there that the compliance program and metrics reporting requirements present a disproportionate or undue burden on banking entities?

2. How could the final rule be revised to reduce burden associated with the compliance program and reporting requirements? Responses should include supporting data or other appropriate information.

3. Are there categories of entities for which compliance program requirements should be reduced or eliminated? If so, please describe and include supporting data or other appropriate information.

4. How effective are the quantitative measurements currently required by the final rule? Are any of the measurements unnecessary to evaluate Volcker Rule compliance? Are there other measurements that would be more useful in evaluating Volcker Rule compliance?

5. How could additional guidance or adjusted implementation of the existing compliance program and metrics reporting provisions reduce the compliance burden? For example, should the rule permit banking entities to self-define their trading desks, subject to supervisory approval, so that banking entities report metrics on the most meaningful units of organization?

6. How could the final rule be revised to enable banking entities to incorporate technology-based systems when fulfilling their compliance obligations under the Volcker Rule? Could banking entities implement technology-based compliance systems that allow banking entities and regulators to more objectively evaluate compliance with the final rule? What are the advantages and disadvantages of using technology-based compliance systems when establishing and maintaining reasonably designed compliance programs?

7. What additional changes could be made to any other aspect of the final rule to provide additional clarity, remove unnecessary burden, or address any other issues?

Dated: August 1, 2017. Keith A. Noreika, Acting Comptroller of the Currency.
[FR Doc. 2017-16556 Filed 8-4-17; 8:45 am] BILLING CODE 4810-33-P
DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 91 [Docket No.: FAA-2017-0782; Notice No. 91-348] RIN 2120-AK87 Use of Automatic Dependent Surveillance-Broadcast (ADS-B) Out in Support of Reduced Vertical Separation Minimum (RVSM) Operations AGENCY:

Federal Aviation Administration (FAA), Department of Transportation (DOT).

ACTION:

Notice of proposed rulemaking (NPRM).

SUMMARY:

This proposal would revise the FAA's requirements for application to operate in RVSM airspace. The proposal would eliminate the requirement for operators to apply for an RVSM authorization when their aircraft are equipped with qualified ADS-B Out systems and meet specific altitude keeping equipment requirements for operations in RVSM airspace. This proposal recognizes the enhancements in aircraft monitoring resulting from the use of ADS-B Out systems and responds to requests to eliminate the burden and expense of the current RVSM application process for operators of aircraft equipped with qualified ADS-B Out systems.

DATES:

Send comments on or before September 6, 2017.

ADDRESSES:

Send comments identified by docket number FAA-2017-0782 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, 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 20590-0001, 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 www.regulations.gov, as described in the system of records notice (DOT/ALL-14 FDMS), which can be reviewed at 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 20590-0001, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT:

For technical questions concerning this action, contact Madison Walton, Aviation Safety Inspector, Flight Technologies and Procedures Division, Flight Standards Services, AFS-400, Federal Aviation Administration, 470 L'Enfant Plaza, Suite 4102, Washington, DC 20024, Federal Aviation Administration, 800 Independence Avenue SW., Washington, DC 20591; telephone (202) 267-8850; email [email protected]

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

The FAA's authority to issue rules with respect to aviation safety is found in Title 49, United States Code (49 U.S.C.). Sections 106(f), 40113(a), and 44701(a) authorize the FAA Administrator to prescribe regulations necessary for aviation safety. Under Section 40103(b), the FAA is charged with prescribing regulations to enhance the efficiency of the national airspace. This proposed rulemaking is within the scope of these authorities as it removes regulatory requirements that the FAA no longer finds necessary for safe operations in RVSM airspace and establishes requirements for the use of qualified ADS-B Out systems to facilitate operations in that airspace.

I. Executive Summary A. Summary of the Proposed Rule

This proposal would permit an operator of an aircraft equipped with a qualified ADS-B Out system meeting altitude keeping equipment performance requirements for operations in RVSM airspace to operate in that airspace without requiring a specific authorization. Under this proposal the FAA would consider a qualified ADS-B Out system to be one that meets the requirements of § 91.227 of Title 14, Code of Federal Regulations (14 CFR).

The requirement for operators to obtain a specific RVSM authorization was first promulgated in 1997 when most aircraft required significant design changes to qualify for an authorization. At that time, operators lacked familiarity with RVSM operations and were required to submit a detailed application to the FAA for review to obtain an RVSM authorization. This application included information on the operator's compliance with RVSM equipment standards, a description of the operator's RVSM maintenance program, and evidence of initial and recurrent pilot training. Since then, operators have become more familiar with RVSM operations, requirements, and procedures. Additionally, the height-keeping performance of aircraft equipped with ADS-B Out systems can be continually monitored to confirm that these aircraft are meeting RVSM performance standards. Based on the technological advances provided by ADS-B Out systems, detailed applications and specific authorizations for operators of these aircraft to conduct operations in RVSM airspace is no longer required.

Accordingly, under this proposal, the requirement to submit applications for RVSM authorization would no longer be applied to operators of aircraft that are equipped with qualified ADS-B Out systems and meet altitude-keeping equipment performance requirements for operations in RVSM airspace. By eliminating this application requirement, the proposal would reduce both operators' costs and FAA workload, while maintaining the existing level of safety. Additionally, since RVSM airspace has been implemented worldwide, the proposal would also remove the detailed designations of where RVSM may be applied that are currently found in Appendix G of part 91.

B. Summary of Costs and Benefits

This proposal would not impose any costs on regulated entities. The FAA estimates that the proposal would result in approximately $35 million (30.8 million of 7% present value) in cost savings during the first 5 years of the rule's implementation primarily resulting from the ability of operators to operate their aircraft at more fuel efficient RVSM altitudes. The FAA estimates that this proposed rulemaking would save each affected small entity operating aircraft equipped with qualified ADS-B Out systems under parts 91 and 135 a total of $1,630. Savings would result from the benefit of not having to apply for RVSM authorizations and from reduced fuel costs associated with not being restricted from RVSM operations while the authorization is processed.

II. Background A. Statement of the Problem

The current process for obtaining RVSM authorizations was developed when RVSM airspace was initially implemented in 1997 (62 FR 17487; Apr. 9, 1997). At that time, most aircraft were not manufactured to comply with RVSM performance requirements and needed significant modifications to meet the altimetry system performance requirements necessary for flight in RVSM airspace. Since the reduced vertical separation standards employed in RVSM airspace were new to most pilots and air traffic controllers, validation of operational policies and procedures to operate in that airspace was necessary to ensure effective implementation of these reduced vertical separation standards. To assist in accomplishing this task, the FAA established systems to provide height-keeping performance monitoring with the overall goal to ensure that aircraft airworthiness, maintenance, and operational approval requirements resulted in the level of safety and system performance necessary to operate in this airspace on a continuing basis. The technology originally used to monitor an aircraft's performance was limited and capable of only a small number of aircraft observations during a flight.

Since that time, RVSM technology has matured and most aircraft manufactured today that are capable of operating in RVSM airspace are delivered from the manufacturer as RVSM compliant. RVSM airspace has been implemented worldwide, familiarity with operational policy and procedures has significantly increased, and the vast majority of the RVSM capable fleet demonstrates excellent altimetry system performance.1 Additionally, the increasing equipage of aircraft with ADS-B Out systems makes the current process of obtaining RVSM authorizations for operation of those aircraft in RVSM airspace unnecessary, as ADS-B Out enables continual monitoring of aircraft height-keeping performance and rapid notification of altimetry system error (ASE).

1 FAA analysis of 22,154 U.S. registered RVSM approved airplanes estimates that 99.9% of those aircraft operate within the ASE containment standards specified in part 91, Appendix G of part 91. The RVSM target level of safety in the national airspace has been met every year since 2003 when RVSM operations started.

B. History of Vertical Separation Standards

Vertical separation standards establish the minimum vertical distance between aircraft routes in the national airspace system. In the early 1970's, increasing air-traffic volume and fuel costs sparked an interest in reducing vertical separation standards for aircraft operating above Flight Level (FL)290.2 At the time, the FAA required aircraft operating above FL290 to maintain a minimum of 2,000 feet of vertical separation between routes. Use of these high-altitude routes was desirable because the diminished atmospheric drag at high altitudes results in a corresponding increase in aircraft fuel efficiency. Operators sought, and continue to seek, not only the most direct routes, but also the most efficient altitudes for their aircraft. Increased demand for these high-altitude routes, however, has resulted in greater aircraft congestion in this airspace.

2 Above 18,000 feet, FL are a measure of altitude assigned in 500-foot. increments; FL290 represents an altitude of 29,000 feet with standard atmospheric pressure of 29.92 inches in mercury (Hg).

In 1973, the Air Transport Association of America petitioned the FAA to reduce the vertical separation of high altitude routes from 2,000 feet to 1,000 feet. The FAA denied the petition in 1977, in part because the technology to meet these more rigorous separation standards was neither generally available nor proven. Deficiencies included insufficient aircraft altitude-keeping standards, lack of maintenance and operational standards, and limited altitude correction technology.

In mid-1981, the FAA initiated the Vertical Studies Program. This program, in conjunction with RTCA (formerly the Radio Technical Commission for Aeronautics) Special Committee (SC)-150 and the International Civil Aviation Organization (ICAO) Review of General Concept of Separation Panel (RGCSP), determined:

• RVSM is “technically feasible without imposing unreasonably demanding technical requirements on the equipment.”

• RVSM could provide “significant benefits in terms of economy and en-route airspace capacity.”

• Implementation of RVSM would require “sound operational judgment supported by an assessment of system performance based on: aircraft altitude-keeping capability, operational considerations, system performance monitoring, and risk assessment.”

Following these determinations, the FAA began a two-phase implementation process for RVSM operations for aircraft registered in the United States (U.S.). During the first phase in 1997, the FAA added § 91.706 (Operations within airspace designed as RVSM Airspace) and Appendix G (Operations in RVSM Airspace) to part 91 (62 FR 17487; Apr. 9, 1997). Section 91.706 permits operators of U.S.-registered aircraft to operate in RVSM airspace outside of the U.S. in accordance with the provisions of Appendix G. Appendix G contains a set of operational, design, maintenance, and other standards applicable to operators seeking to operate in RVSM airspace. It specifies a detailed application process that requires operators to provide evidence that the operator's aircraft design satisfies RVSM performance requirements and has policies and procedures for the safe conduct of RVSM operations. Until recently, it also required that the operator have a specific program for the maintenance of RVSM systems and equipment. The FAA reviews the applications and grants authorizations to operate in RVSM airspace after finding that the applicable requirements are met.

The second phase of RVSM implementation occurred in October 2003, with a second RVSM-related rulemaking action (68 FR 61304; Oct. 27, 2003). This rule introduced RVSM airspace in the U.S. and used the same authorization process previously established under Appendix G to part 91. As established in 2003, the FAA's RVSM program allows for 1,000 feet of vertical separation for aircraft between FL290 and FL410. Before this final rule, air traffic controllers could only assign aircraft operating under Instrument Flight Rules (IFR) flying at FL290 and above to FL290, 310, 330, 350, 370, 390, and 410 since the existing vertical separation standard was 2,000 feet. After the rule changes went into effect, IFR aircraft could also fly at FL300, 320, 340, 360, 380, and 400—nearly doubling capacity within this particular segment of airspace.

The FAA also implemented a performance monitoring program to support implementation of RVSM. This program includes Global Positioning System (GPS)-based height-keeping monitoring units (GMUs) capable of being deployed onboard aircraft during individual RVSM flights. Later, in 2005, the FAA deployed the first of five passive ground-based aircraft geometric height measurement element (AGHME) sites in the continental U.S. to conduct height-keeping performance monitoring of aircraft passing over each site. Other civil aviation authorities throughout the world have also developed similar height monitoring sites.

In 2008, the FAA reviewed its RVSM program and operator authorization policies. At that time, there were more than 7,000 active RVSM authorizations, covering in excess of 15,000 U.S.-registered aircraft. The FAA's evaluation found the existing processes ensured compliance with the RVSM operating requirements. At the same time however, FAA representatives began meeting with the National Business Aviation Association (NBAA) to develop ways to streamline the RVSM application process to lower the burden on operators to obtain RVSM authorizations and reduce the FAA's workload associated with processing and granting these authorizations. The parties formed the RVSM Process Enhancement Team (PET) within the Performance based Aviation Rulemaking Committee. The PET submitted its final recommendations to the FAA in 2013. As a result the FAA revised existing policies and guidance to facilitate more efficient processing of requests to change existing authorizations and created a job aid to assist inspectors in standardizing review of operator applications.

The FAA also completed rulemaking in 2016 to further reduce the burden on applicants by eliminating the requirement that RVSM applicants include an approved RVSM maintenance program as part of an application for an RVSM authorization. (81 FR 47009, Jul. 20, 2016)

III. Discussion of the Proposal

This proposed rulemaking would permit operators of qualified ADS-B Out equipped aircraft to operate without submitting an application for an RVSM authorization when operating where the FAA has ADS-B coverage sufficient to confirm RVSM height-keeping performance. The proposal would eliminate this process for aircraft equipped with qualified ADS-B Out systems as a result of the agency's ability to effectively and continually monitor the height-keeping performance of these aircraft.

A. Specific Requirements for Aircraft Equipped With Qualified ADS-B Out Systems

This proposal would add a new Section 9 (Aircraft Equipped with Automatic Dependent Surveillance-Broadcast Out) to Appendix G of part 91. The proposal would authorize operators of aircraft, equipped with qualified ADS-B Out systems, (i.e. systems that meet the requirements of 14 CFR 91.227) that can be monitored by the FAA to conduct RVSM operations without submitting an application for an authorization to operate in RVSM airspace. The height-keeping performance of these aircraft would be required to be equivalent to that achieved by individual aircraft approved under current provisions of Section 2 of Appendix G.

To be eligible for operations in RVSM airspace an operator's aircraft must meet strict height-keeping performance standards. Under this proposal, an operator would be authorized to conduct flight in airspace in which RVSM is applied when the operator's aircraft complies with the provisions proposed in Section 9. These operations would be conducted in airspace where the FAA has ADS-B coverage sufficient to confirm RVSM height-keeping performance.3 No specific authorization would be necessary. However, an operator could still operate with an authorization issued under the provisions of Section 3 of Appendix G if its aircraft are not equipped with a qualified ADS-B Out system. The FAA also notes that if a foreign country requires a specific authorization to operate in RVSM airspace an operator may need to seek authorization under the provisions of Section 3, even if it meets the provisions of proposed Section 9.

3 Airspace where the FAA has ADS-B coverage sufficient to confirm RVSM height-keeping performance is depicted at https://www.faa.gov/nextgen/programs/adsb/coveragemap. This coverage area may include airspace in which ADS-B equipage is not required.

When RVSM was first established, the FAA and other international air traffic service organizations developed systems for monitoring aircraft altitude-keeping performance. The systems are used to measure Total Vertical Error (TVE), including ASE. The overall goal of height-keeping performance monitoring is to ensure that airworthiness, maintenance and operational approval requirements result in required system performance and level of safety in the flight environment on an ongoing basis. Aircraft equipped with qualified ADS-B Out systems continuously transmit aircraft geometric position information used to calculate their height-keeping performance.

Operators wishing to take advantage of proposed Section 9's provisions would be required to operate aircraft equipped with a qualified ADS-B Out system installed as specified in proposed Section 9(a)(5) which would allow the FAA to monitor the aircraft height-keeping performance in RVSM airspace where the FAA has ADS-B coverage. This monitoring capability enables the FAA to eliminate the application process for RVSM authorization. The ADS-B Out equipment requirement in proposed Section 9(a)(5) is necessary for aircraft height-keeping performance monitoring, but not for aircraft height-keeping capability. Accordingly, as proposed in Section 9(a)(5), an aircraft that the FAA has previously been found to be operating within required height-keeping performance parameters may be authorized to operate in RVSM airspace when ADS-B Out is inoperable for a specific flight.

The proposal also specifies, in Section 9(a), the essential aircraft equipment and capabilities, including altitude measurement systems; altitude control systems; and altitude alert systems, required to be operational for the aircraft to be eligible for RVSM. The proposed RVSM height-keeping equipment requirements in Section 9(a) are the same as those for non-ADS-B Out equipped aircraft in paragraph (c) of Section 2 of Appendix G. The FAA has determined the current fleet of RVSM approved aircraft consistently meet FAA established safety standards and accordingly has not proposed any changes to the current RVSM equipment standards for ADS-B Out equipped aircraft.4

4 The RVSM target level of safety in the national airspace has been met every year since 2003 when RVSM operations started.

The FAA notes that a Traffic Collision Avoidance Alert System (TCAS) is not specifically required for RVSM operations. Other FAA regulations specify when an aircraft must be equipped with a collision avoidance system. However, for operations in RVSM airspace, aircraft that are equipped with TCAS II must meet Technical Standards Order (TSO) C-119b and be modified to incorporate software Version 7.0, or a later version. This requirement is specified as an aircraft approval requirement in current paragraph (g) of Section 2 of Appendix G. The proposed requirement for operators of ADS-B Out equipped aircraft seeking to operate in RVSM airspace that are also equipped with TCAS II must meet TSO C-119b (Version 7.0), or later, is necessary because earlier TCAS software versions did not incorporate revised alert thresholds for traffic alerts (TA) and resolution advisories (RA) for FL300 through FL420 that are compatible with RVSM operations. These provisions for TCAS II equipped aircraft in paragraph (a)(4) of proposed Section 9 are identical to current provisions for existing RVSM aircraft approval under Section 2 of Appendix G.

Additionally, the FAA also proposes a single ASE containment requirement for aircraft equipped with ADS-B Out in proposed Section 9(b). This requirement corresponds to limits for ASE containment when RVSM was first established and is consistent with RVSM performance criteria used for aircraft approval in Section 2 of Appendix G. It allows performance monitoring to be applied to each aircraft without relying on aggregated data collected from many aircraft of the same RVSM monitoring group. For these operations, the FAA can rapidly detect when individual aircraft performance has deteriorated outside the proposed ASE tolerance. The proposal would require that aircraft continually meet this requirement to be eligible for RVSM operations under the provisions of this proposed section.

B. Removal of Specific Airspace Designations

As discussed in the “Background” section of this document, RVSM was implemented regionally in a phased approach. Section 8 (Airspace Designation) of Appendix G was initially designed to be updated whenever regions added RVSM airspace. The inability to rapidly update these designations caused discrepancies between the airspace listed in Section 8 of Appendix G and the airspace in which RVSM had been applied. Today, however, RVSM has been established between FL290 and FL410 in all flight information regions (FIRs) 5 and requirements have been harmonized throughout ICAO member States. Accordingly, there is no longer a need to update the airspace designations listed in Section 8. The proposed amendment to this section acknowledges RVSM is now applied worldwide 6 and removes the detailed RVSM airspace designations from that section.

5 A FIR is airspace of defined dimensions within which Flight Information Service and Alerting Service are provided. All U.S. airspace is contained with designated FIRs.

6 An operator may choose to review a State's AIP for individual areas where RVSM is applied.

C. Conforming Amendments

Additional amendments to Appendix G to part 91 are proposed to facilitate the addition of the approval requirements specified in Section 9 for ADS-B Out equipped aircraft.

The proposed changes to Section 1 (RVSM definition), recognize that RVSM is no longer a new concept and that RVSM operations have become a standard operation between FL290 and FL410. Accordingly, the proposed changes to this section would remove the “special qualification” designation for RVSM airspace and references referring to operator specific approvals. Since RVSM has now been implemented worldwide, a reference to RVSM airspace identified in Section 8 is no longer needed and would be removed.

The proposed changes in Section 2 (Aircraft Approval) and Section 3 (Operator Authorization) recognize that aircraft operators may either, use the current aircraft approval process specified in Section 2 and the operator authorization process specified in Section 3, or the authorization process proposed in new Section 9 for aircraft equipped with qualified ADS-B Out systems to obtain authorization to conduct RVSM operations.

Proposed changes to paragraphs (a), (b), and (c) in Section 3 (Operator Authorization) would not only allow for an operator to be authorized to conduct flight in airspace where RVSM is applied under the provisions of this section as is currently permitted but would also recognize that operators would be authorized to conduct RVSM operations under the provisions of proposed Section 9.

Additionally, under the provisions of current Section 3 (Operator Authorization), each operator must provide evidence that each of its pilots has adequate knowledge of RVSM requirements, policies, and procedures when applying for an RVSM authorization. To better clarify the intent of the rule, current Section (3)(c) would be revised to state that “each pilot has knowledge of RVSM requirements, policies, and procedures sufficient for the conduct operations in RVSM airspace”.

To ensure the pilots of aircraft of operators who have been authorized to conduct RVSM operations in accordance with proposed Section 9 have knowledge of the requirements, policies, and procedures sufficient for the conduct operations in RVSM airspace, proposed paragraph (b)(3) would be added to Section 4 (RVSM Operations). The new provision is identical to revised Section 3(c)(2). Knowledge sufficient to conduct RVSM operations includes, but is not limited to; RVSM FL protocols, flight planning requirements, inflight procedures, and contingency procedures for areas of intended operation. The FAA publishes applicable guidance material in the Aeronautical Information Manual (AIM), Aeronautical Information Publication (AIP), and Advisory Circular (AC) 91-85. Proposed Section 4 has also been revised to specify that an operator may be authorized to conduct RVSM operations under the provisions of Section 3 (as is currently stated) or under proposed Section 9.

Section 5 (Deviation Authority Approval) would be revised to eliminate the specific references to Section 3 since the Administrator may authorize deviations from the requirements in § 91.180 and § 91.706 for a specific flight in RVSM airspace for operators who may not meet the provisions of current Section 3 or proposed Section 9. This section would be revised to address the inclusion of proposed Section 9 in Appendix G.

Currently Section 7 (Removal or Amendment of Authority) states that the Administrator may revoke or restrict an RVSM authorization or RVSM letter of authorization. This section would be revised to eliminate specific references to the revocation or restriction of RVSM authorizations and letters of authorization and replace those provisions with a more general provision stating that the Administrator may prohibit or restrict operation in RVSM airspace if an operator fails to comply with certain specified provisions. This revision is necessary as the current section only addresses the removal or amendment of authority through operations specifications, management specifications, and letters of authorization. As the proposal would permit RVSM operations to be conducted without a specific authorization document issued by the Administrator, this section has been revised to indicate that the Administrator may prohibit or restrict an operator's ability to operate in RVSM airspace even if that authorization is not specified in operations specifications, management specifications, or a letter of authorization.

D. Implementing Information

The FAA would perform height-keeping performance monitoring on ADS-B Out equipped flights operating at RVSM altitudes for all airspace defined in § 91.225. This monitoring capability is the result of the FAA having access to ADS-B data from flights in RVSM airspace which would be obtained during normal operations. ADS-B Out systems, meeting the performance requirements of § 91.227, transmit the necessary aircraft position information to allow the FAA to perform height-keeping performance monitoring on a continual basis. This level of monitoring was not previously available due to the limited number and range of AGHME systems or special effort required to fly with a GPS-based monitoring unit (GMU) on board an aircraft for an individual flight. The continual monitoring enabled by ADS-B Out provides increased height-keeping performance data on an individual aircraft basis and enables the FAA to identify poor ASE performance sooner, allowing quicker mitigation of any risk posed by poor performing aircraft. Additionally, in airspace where the U.S. performs ADS-B monitoring, operators of ADS-B Out aircraft would be able to begin RVSM operations immediately. This ability to operate immediately would lower costs and eliminate the delay caused during the processing of an application for authorization.

For operations outside U.S. airspace, where ADS-B height monitoring may not be available, an aircraft that has recently been monitored by the FAA and found to be operating normally could be safely operated outside of FAA-monitored airspace with a high degree of confidence that the performance requirements would continue to be met.

The FAA has developed and maintains guidance for operators, based on statistical performance analysis, on the time interval that aircraft should return to airspace with FAA ADS-B monitoring capability or obtain a traditional RVSM approval to ensure that the aircraft meets applicable performance requirements. Advisory Circular AC 91-85, Authorization of Aircraft and Operators for Flight in Reduced Vertical Separation Minimum (RVSM) Airspace, includes the initial criteria which would be revised with ongoing monitoring experience. The FAA may also expand the airspace in which we collect ADS-B data, through collaboration with other air navigation service providers or operators.

The FAA will maintain a database of aircraft that have been monitored and are performing within the required performance as specified in proposed Section 9. When a new aircraft is entered into service, the operator must have the initial flight in airspace that can be monitored by the FAA in order to take advantage of proposed Section 9. For a new aircraft that is entered into service and cannot be monitored by the FAA (such as manufactured and delivered outside the U.S.), the operator should obtain an approval in accordance with section 3 before operating in RVSM airspace.

In addition, the FAA intends to transition current approvals, issued under section 3, to monitored operations under the provisions of section 9, in order to reduce the operator and FAA administrative burden of maintaining the section 3 approval. Once an operator's fleet of aircraft have been monitored, the FAA intends to notify the operator that the section 3 approval will be terminated and their authority to operate in RVSM transferred to the provisions of section 9. The FAA will allow operators to maintain their section 3 approval if the operator notifies the FAA that a specific authorization is required for operations in another country.

The FAA also plans to share ADS-B performance concepts and monitoring techniques with ICAO, so that other States can perform their own RVSM performance monitoring.7 The FAA would publish guidance material addressing the frequency, durability, and coverage of our ADS-B monitoring that we find acceptable and work with ICAO to develop guidance applicable to RVSM capable aircraft equipped with ADS-B Out systems. The FAA would make aircraft performance summaries available to operators to assist them in assuring compliance with the RVSM performance requirements. The FAA believes that the implementing actions described in this proposal would reduce operator and FAA workload and expense, with no additional risk.

7 Currently Australia, Thailand, China, and Hong Kong utilize ADS-B Out for RVSM height-keeping performance monitoring. Eurocontrol, Japan, Russia, and other States are considering its use.

IV. Regulatory Notices and Analyses A. Regulatory Evaluation

Changes to Federal regulations must undergo several economic analyses. First, Executive Order 12866 and Executive Order 13563 direct that each Federal agency shall propose or adopt a regulation only upon a reasoned determination that the benefits of the intended regulation justify its costs. Second, the Regulatory Flexibility Act of 1980 (Pub. L. 96-354) requires agencies to analyze the economic impact of regulatory changes on small entities. Third, the Trade Agreements Act (Pub. L. 96-39) prohibits agencies from setting standards that create unnecessary obstacles to the foreign commerce of the United States. In developing U.S. standards, this Trade Act requires agencies to consider international standards and, where appropriate, that they be the basis of U.S. standards. Fourth, the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) requires agencies to prepare a written assessment of the costs, benefits, and other effects of proposed or final rules that include a Federal mandate likely to result in the expenditure by State, local, or tribal governments, in the aggregate, or by the private sector, of $100 million or more annually (adjusted for inflation with base year of 1995; current value is $155 million). This portion of the preamble summarizes the FAA's analysis of the economic impacts of this proposed rule. We suggest readers seeking greater detail read the full regulatory evaluation, a copy of which we have placed in the docket for this rulemaking.

In conducting these analyses, the FAA has determined that this proposed rule: (1) Has benefits that justify its costs, (2) is not an economically “significant regulatory action” as defined in Section 3(f) of Executive Order 12866, (3) is “nonsignificant” as defined in DOT's Regulatory Policies and Procedures; (4) would not have a significant economic impact on small entities; (5) would not create unnecessary obstacles to the foreign commerce of the U.S.; and (6) would not impose an unfunded mandate on state, local, or tribal governments, or on the private sector by exceeding the threshold identified above. These analyses are summarized below.

i. Who is potentially affected by this rule?

All operators intending to conduct operations between FL290 and FL410 (RVSM designated Airspace) and have 1,000 feet vertical separation applied. This applies to operations conducted under parts 91, 91K, 121, 125, and 135.

ii. Assumptions

• Present value estimates based on OMB guidance using a 7% discount rate.

• This proposed rule would become effective in 2018.

• The analysis period is 5 years from 2018 to 2022.

The average equipage rate of ADS-B Out in RVSM airspace will be 83% in 2018, 95% in 2019, and reach 100% on January 1, 2020.

iii. Benefits and Cost Savings of This Rule

The proposal would permit an operator of an aircraft meeting equipment requirements for operations in RVSM airspace and equipped with a qualified ADS-B Out system to operate in RVSM airspace without requiring application for a specific authorization. This rulemaking proposes to eliminate this application requirement, thereby reducing both operators' costs and FAA workload, while maintaining the existing level of safety. The biggest savings comes not from the paperwork savings but from fuel savings. Currently operators without RVSM approval must operate their airplane at lower altitudes.

Total savings during the first 5 years of the rule's implementation would be approximately $35.3 million ($30.8 million present value at 7%).

B. Regulatory Flexibility Determination

The Regulatory Flexibility Act of 1980 (Pub. L. 96-354) (RFA) establishes “as a principle of regulatory issuance that agencies shall endeavor, consistent with the objectives of the rule and of applicable statutes, to fit regulatory and informational requirements to the scale of the businesses, organizations, and governmental jurisdictions subject to regulation.” To achieve this principle, agencies are required to solicit and consider flexible regulatory proposals and to explain the rationale for their actions to assure that such proposals are given serious consideration. The RFA covers a wide-range of small entities, including small businesses, not-for-profit organizations, and small governmental jurisdictions.

Agencies must perform a review to determine whether a rule would have a significant economic impact on a substantial number of small entities. If the agency determines that it would, the agency must prepare a regulatory flexibility analysis as described in the RFA.

However, if an agency determines that a rule is not expected to have a significant economic impact on a substantial number of small entities, Section 605(b) of the RFA provides that the head of the agency may so certify and a regulatory flexibility analysis is not required. The certification must include a statement providing the factual basis for this determination, and the reasoning should be clear. The FAA estimates that this proposed rulemaking would save each affected small entity operating aircraft equipped with qualified ADS-B Out systems under Part 91 and Part 135 $1,630 8 from not having to apply for an RVSM authorization and from reduced fuel cost associated with not being restricted from RVSM operations while the authorization is processed. The FAA then compared this cost saving with a weighted average aircraft value of representative aircraft that would potentially be affected by this rule (See following table).

8 Total relief of $1,630 for each Part 91 and Part 135 aircraft seeking authorization equipped with ADS-B Out is the sum of the estimated $214 per application preparation relief, plus the per aircraft fuel savings estimate of $1,416.

EP07AU17.022

Owners of new turbojet or turboprop airplanes would receive a benefit of $1,630 per new airplane. But, for new turbojet or turboprop airplanes whose value exceeds $3 million, the cost savings of less than $2,000 is not economically significant. If an agency determines that a rulemaking will not result in a significant economic impact on a substantial number of small entities, the head of the agency may so certify under Section 605(b) of the RFA. Therefore, as provided in Section 605(b), the head of the FAA certifies that this rulemaking will not result in a significant economic impact on a substantial number of small entities.

C. International Trade Impact Assessment

The Trade Agreements Act of 1979 (Pub. L. 96-39), as amended by the Uruguay Round Agreements Act (Pub. L. 103-465), prohibits Federal agencies from establishing standards or engaging in related activities that create unnecessary obstacles to the foreign commerce of the United States. Pursuant to these Acts, the establishment of standards is not considered an unnecessary obstacle to the foreign commerce of the U.S., so long as the standard has a legitimate domestic objective, such as the protection of safety, and does not operate in a manner that excludes imports that meet this objective. The statute also requires consideration of international standards, and where appropriate, that they be the basis for U.S. standards. The FAA has assessed the potential effect of this proposed rule and determined that it would have the same impact on domestic and international entities and thus has a neutral trade impact.

D. Unfunded Mandates Assessment

Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) requires each Federal agency to prepare a written statement assessing the effects of any Federal mandate in a proposed or final agency rule that may result in an expenditure of $100 million or more (in 1995 dollars) in any 1 year by State, local, and tribal governments, in the aggregate, or by the private sector; such a mandate is deemed to be a “significant regulatory action.” The FAA currently uses an inflation-adjusted value of $155 million in lieu of $100 million. This proposed rule does not contain such a mandate; therefore, the requirements of Title II of the Act do not apply.

E. Paperwork Reduction Act

The Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) requires that the FAA consider the impact of paperwork and other information collection burdens imposed on the public. The FAA has determined that there is no new requirement for information collection associated with this proposed rule.

F. International Compatibility

In keeping with U.S. obligations under the Convention on International Civil Aviation, it is FAA policy to conform to ICAO Standards and Recommended Practices to the maximum extent practicable. The FAA has reviewed the corresponding ICAO Standards and Recommended Practices and has identified no differences with these proposed regulations.

G. Environmental Analysis

FAA Order 1050.1F identifies FAA actions that are categorically excluded from preparation of an environmental assessment or environmental impact statement under the National Environmental Policy Act in the absence of extraordinary circumstances. The FAA has determined this rulemaking action qualifies for the categorical exclusion identified in paragraph 5-6.6 and involves no extraordinary circumstances.

V. Executive Order Determinations A. Executive Order 13771, Reducing Regulation and Controlling Regulatory Costs

Executive Order 13771 titled “Reducing Regulation and Controlling Regulatory Costs,” directs that, unless prohibited by law, whenever an executive department or agency publicly proposes for notice and comment or otherwise promulgates a new regulation, it shall identify at least two existing regulations to be repealed. In addition, any new incremental costs associated with new regulations shall, to the extent permitted by law, be offset by the elimination of existing costs. Only those rules deemed significant under section 3(f) of Executive Order 12866, “Regulatory Planning and Review,” are subject to these requirements.

This proposed rule is expected to be an E.O. 13771 deregulatory action. Details on the estimated costs savings of this proposed rule can be found in the rule's economic analysis.

B. Executive Order 13132, Federalism

The FAA has analyzed this proposed rule under the principles and criteria of Executive Order 13132, Federalism. The agency has determined that this action would not have a substantial direct effect on the States, or the relationship between the Federal Government and the States, or on the distribution of power and responsibilities among the various levels of government, and, therefore, would not have Federalism implications.

C. Executive Order 13211, Regulations That Significantly Affect Energy Supply, Distribution, or Use

The FAA analyzed this proposed rule under Executive Order 13211, Actions Concerning Regulations that Significantly Affect Energy Supply, Distribution, or Use (May 18, 2001). The agency has determined that it would not be a “significant energy action” under the executive order and would not be likely to have a significant adverse effect on the supply, distribution, or use of energy.

VI. Additional Information A. Comments Invited

The FAA invites interested persons to participate in this rulemaking by submitting written comments, data, or views. The agency also invites comments relating to the economic, environmental, energy, or federalism impacts that might result from adopting the proposals in this document. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. To ensure the docket does not contain duplicate comments, commenters should send only one copy of written comments, or if comments are filed electronically, commenters should submit only one time.

The FAA will file in the docket all comments it receives, as well as a report summarizing each substantive public contact with FAA personnel concerning this proposed rulemaking. Before acting on this proposal, the FAA will consider all comments it receives on or before the closing date for comments. The FAA will consider comments filed after the comment period has closed if it is possible to do so without incurring expense or delay. The agency may change this proposal in light of the comments it receives.

Proprietary or Confidential Business Information: Commenters should not file proprietary or confidential business information in the docket. Such information must be sent or delivered directly to the person identified in the FOR FURTHER INFORMATION CONTACT section of this document, and marked as proprietary or confidential. If submitting information on a disk or CD ROM, mark the outside of the disk or CD ROM, and identify electronically within the disk or CD ROM the specific information that is proprietary or confidential.

B. Availability of Rulemaking Documents

An electronic copy of rulemaking documents may be obtained from the Internet by—

1. Searching the Federal eRulemaking Portal (http://www.regulations.gov);

2. Visiting the FAA's Regulations and Policies Web page at http://www.faa.gov/regulations_policies or

3. Accessing the Government Printing Office's Web page at http://www.thefederalregister.org/fdsys/.

Copies may also be obtained by sending a request to the Federal Aviation Administration, Office of Rulemaking, ARM-1, 800 Independence Avenue SW., Washington, DC 20591, or by calling (202) 267-9677. Commenters must identify the docket or notice number of this rulemaking.

All documents the FAA considered in developing this proposed rule, including economic analyses and technical reports, may be accessed from the Internet through the Federal eRulemaking Portal referenced in item (1) above.

List of Subjects in 14 CFR Part 91

Aircraft, Air traffic control, Aviation safety.

The Proposed Amendment

In consideration of the foregoing, the FAA proposes to amend Chapter I of title 14, Code of Federal Regulations as follows:

PART 91—OPERATION AND FLIGHT RULES GENERAL 1. The authority citation for part 91 continues to read as follows: Authority:

49 U.S.C. 106(f), 106(g), 1155, 40101, 40103, 40105, 40113, 40120, 44101, 44111, 44701, 44704, 44709, 44711, 44712, 44715, 44716, 44717, 44722, 46306, 46315, 46316, 46504, 46506-46507, 47122, 47508, 47528-47531, 47534, articles 12 and 29 of the Convention on International Civil Aviation (61 Stat. 1180), (126 Stat. 11)

2. Amend Appendix G to part 91 by: a. Revising the definition of Reduced Vertical Separation Minimum (RVSM) Airspace in Section 1; b. Revise paragraph 2(a) in Section 2; c. Revise paragraphs 3(a), 3(b) introductory text, 3(c) introductory text, and 3(c)(2) in Section 3; d. Revise paragraphs 4(b)(1) and 4(b)(2) and add paragraph 4(b)(3) in Section 4; e. Revise the introductory text and paragraph 5(b) in Section 5; f. Revise the introductory text in Section 7; g. Revise Section 8; h. Add Section 9.

The revisions and additions read as follows:

Section 1. Definitions

Reduced Vertical Separation Minimum (RVSM) Airspace. Within RVSM airspace, air traffic control (ATC) separates aircraft by a minimum of 1,000 feet vertically between FL 290 and FL 410 inclusive. Air-traffic control notifies operators of RVSM airspace by providing route planning information.

Section 2. Aircraft Approval

(a) Except as specified in Section 9 of this appendix, an operator may be authorized to conduct RVSM operations if the Administrator finds that its aircraft comply with this section.

Section 3. Operator Authorization

(a) Except as specified in Section 9 of this appendix, authority for an operator to conduct flight in airspace where RVSM is applied is issued in operations specifications, a Letter of Authorization, or management specifications issued under subpart K of this part, as appropriate. To issue an RVSM authorization under this section, the Administrator must find that the operator's aircraft have been approved in accordance with Section 2 of this appendix and the operator complies with this section.

(b) Except as specified in Section 9 of this appendix, an applicant seeking authorization to operate within RVSM airspace must apply in a form and manner prescribed by the Administrator. The application must include the following:

(1) * * *

(2) * * *

(3) * * *

(c) In a manner prescribed by the Administrator, an operator seeking authorization under this section must provide evidence that:

(1) * * *

(2) Each pilot has knowledge of RVSM requirements, policies, and procedures sufficient for the conduct of operations in RVSM airspace.

Section 4. RVSM Operations

(a) * * *

(b) * * *

(1) The operator is authorized by the Administrator to perform such operations in accordance with Section 3 or Section 9 of this appendix, as applicable.

(2) The aircraft—

(i) Has been approved and complies with Section 2 of this appendix; or

(ii) Complies with Section 9 of this appendix.

(3) Each pilot has knowledge of RVSM requirements, policies, and procedures sufficient for the conduct of operations in RVSM airspace.

Section 5. Deviation Authority Approval

The Administrator may authorize an aircraft operator to deviate from the requirements of § 91.180 or § 91.706 for a specific flight in RVSM airspace if—

(a) * * *

(b) At the time of filing the flight plan for that flight, ATC determines that the aircraft may be provided appropriate separation and that the flight will not interfere with, or impose a burden on, RVSM operations.

Section 7. Removal or Amendment of Authority

The Administrator may prohibit or restrict an operator from conducting operations in RVSM airspace, if the Administrator determines that the operator is not complying, or is unable to comply, with this appendix or subpart H of this part. Examples of reasons for amendment, revocation, or restriction include, but are not limited to, an operator's:

Section 8. Airspace Designation

RVSM may be applied in all ICAO Flight Information Regions (FIRs).

Section 9. Aircraft Equipped With Automatic Dependent Surveillance—Broadcast Out

An operator is authorized to conduct flight in airspace in which RVSM is applied provided:

(a) The aircraft is equipped with the following:

(1) Two operational independent altitude measurement systems.

(2) At least one automatic altitude control system that controls the aircraft altitude—

(i) Within a tolerance band of ±65 feet about an acquired altitude when the aircraft is operated in straight and level flight under nonturbulent, nongust conditions; or

(ii) Within a tolerance band of ±130 feet under nonturbulent, nongust conditions for aircraft for which application for type certification occurred on or before April 9, 1997 that are equipped with an automatic altitude control system with flight management/performance system inputs.

(3) An altitude alert system that signals an alert when the altitude displayed to the flight crew deviates from the selected altitude by more than—

(i) ±300 feet for aircraft for which application for type certification was made on or before April 9, 1997; or

(ii) ±200 feet for aircraft for which application for type certification is made after April 9, 1997.

(4) A TCAS II that meets TSO C-119b (Version 7.0), or a later version, if equipped with TCAS II, unless otherwise authorized by the Administrator.

(5) Unless authorized by ATC or the foreign country where the aircraft is operated, an ADS-B Out system that meets the equipment performance requirements of § 91.227 of this part. The aircraft must have its height-keeping performance monitored in a form and manner acceptable to the Administrator.

(b) The altimetry system error (ASE) of the aircraft does not exceed 200 feet when operating in RVSM airspace.

Issued under authority provided by 49 U.S.C. 106(f), 40103(b), 40113(a), and 44701(a) in Washington, DC, on July 26, 2017. John Barbagallo, Deputy Director, Flight Standards Service.
[FR Doc. 2017-16197 Filed 8-4-17; 8:45 am] BILLING CODE 4910-13-P
CONSUMER PRODUCT SAFETY COMMISSION 16 CFR Chapter II [CPSC Docket No. CPSC-2015-0022] Products Containing Organohalogen Flame Retardants; Notice of Opportunity for Oral Presentation of Comments AGENCY:

Consumer Product Safety Commission.

ACTION:

Notice of opportunity for oral presentation of comments.

SUMMARY:

The Consumer Product Safety Commission (CPSC or Commission) announces that there will be an opportunity for interested persons to present oral comments on the petition requesting that the Commission initiate rulemaking under the Federal Hazardous Substances Act (FHSA) to declare several categories of products containing additive organohalogen flame retardants to be “banned hazardous substances.”

DATES:

The meeting will begin at 10 a.m., September 14, 2017. Requests to make oral presentations and the written text of any oral presentations must be received by the Office of the Secretary not later than 5 p.m. Eastern Daylight Time (EDT) on August 31, 2017.

ADDRESSES:

The meeting will be held at 4330 East West Highway, Bethesda, MD 20814. Requests to make oral presentations, and texts of oral presentations, should be captioned: “Organohalogen Flame Retardants Petition; Oral Presentation” and submitted by email to [email protected], or mailed or delivered to the Office of the Secretary, Consumer Product Safety Commission, 4330 East West Highway, Bethesda, MD 20814, not later than 5 p.m. EDT on August 31, 2017.

FOR FURTHER INFORMATION CONTACT:

For information about the purpose or subject matter of this meeting, contact Michael Babich, Division of Toxicology & Risk Assessment, U.S. Consumer Product Safety Commission, 5 Research Place, Rockville, MD 20850; telephone (301) 987-2606. For information about the procedure to make an oral presentation, contact Rockelle Hammond, Office of the Secretary, Consumer Product Safety Commission, 4330 East West Highway, Bethesda, MD 20814; telephone (301) 504-7923.

SUPPLEMENTARY INFORMATION: A. Background

On July 1, 2015, the Commission received a petition requesting that the Commission initiate rulemaking under the FHSA to declare several categories of products containing additive organohalogen flame retardants to be “banned hazardous substances.” The petition was filed by Earthjustice and the Consumer Federation of America, which are joined by American Academy of Pediatrics, American Medical Women's Association, Consumers Union, Green Science Policy Institute, International Association of Fire Fighters, Kids in Danger, Philip Landrigan, M.D., M.P.H., League of United Latin American Citizens, Learning Disabilities Association of America, and Worksafe. CPSC staff has prepared a briefing package in response to the petition; the briefing package, which includes the petition in its entirety, is available at https://www.cpsc.gov/s3fs-public/PetitionHP15-1RequestingRulemakingonCertainProductsContainingOrganohalogenFlameRetardants.pdf?aTsa_sSaCiSMf1Z_2CfvISjMHFEdWKZ7.

B. The Public Meeting

The Commission is providing this forum for oral presentations concerning the petition. See the information under the headings DATES and ADDRESSES at the beginning of this notice for information on making requests to give oral presentations at the meeting.

Participants should limit their presentations to approximately 10 minutes, exclusive of any periods of questioning by the Commissioners. To prevent duplicative presentations, groups will be directed to designate a spokesperson. The Commission reserves the right to limit the time further for any presentation and impose restrictions to avoid excessive duplication of presentations.

Dated: August 2, 2017. Todd A. Stevenson, Secretary, U.S. Consumer Product Safety Commission.
[FR Doc. 2017-16588 Filed 8-4-17; 8:45 am] BILLING CODE 6355-01-P
POSTAL REGULATORY COMMISSION 39 CFR part 3050 [Docket No. RM2017-11; Order No. 4024] Periodic Reporting AGENCY:

Postal Regulatory Commission.

ACTION:

Notice of proposed rulemaking.

SUMMARY:

The Commission is announcing a recent filing requesting that the Commission initiate an informal rulemaking proceeding to consider changes to an analytical method for use in periodic reporting (Proposal Seven). This document informs the public of the filing, invites public comment, and takes other administrative steps.

DATES:

Comments are due: September 15, 2017.

ADDRESSES:

Submit comments electronically via the Commission's Filing Online system at http://www.prc.gov. Those who cannot submit comments electronically should contact the person identified in the FOR FURTHER INFORMATION CONTACT section by telephone for advice on filing alternatives.

FOR FURTHER INFORMATION CONTACT:

David A. Trissell, General Counsel, at 202-789-6820.

SUPPLEMENTARY INFORMATION: Table of Contents I. Introduction II. Proposal Seven III. Notice and Comment IV. Ordering Paragraphs I. Introduction

On July 28, 2017, the Postal Service filed a petition pursuant to 39 CFR 3050.11 requesting that the Commission initiate an informal rulemaking proceeding to consider changes to an analytical method relating to periodic reports.1 The Petition identifies the proposed analytical method changes filed in this docket as Proposal Seven.

1 Petition of the United States Postal Service for the Initiation of a Proceeding to Consider Proposed Changes in Analytical Principles (Proposal Seven), July 28, 2017 (Petition).

II. Proposal Seven

The Postal Service explains that for many years it has calculated the “USPS Marketing Mail” dropship passthroughs for flats and parcels rate categories only with reference to the per-pound price element above the piece-pound breakpoint. For greater accuracy it proposes to include the per-piece price element below the breakpoint in the calculation. Petition, Proposal Seven at 1.

Background. As currently calculated, the traditional passthrough for “USPS Marketing Mail” flats and parcels divides the discount by the avoided cost as shown in Table 1 attached to the Petition.2 The numerator is the per-pound discount above the breakpoint, for pieces above the breakpoint, versus origin-entered. The denominator is the average avoided cost per pound for all volume, both above and below the breakpoint, versus origin-entered. Petition, Proposal Seven at 1. The Postal Service states this has two shortcomings. The numerator does not include the other price element that varies by depth of entry, the per-piece price element below the breakpoint. Id. Second, the numerator and denominator are mismatched; the numerator represents volume above the breakpoint while the denominator represents volume both above and below the breakpoint. Id. at 1-2.

2 Petition, Excel file “Prop.7.Dropship_Passthroughs.xlsx,” column (h).

Proposal. The Postal Service proposes to calculate dropship passthroughs of “USPS Marketing Mail” flats and parcels rate categories to reflect both price elements that vary by depth of entry (per-pound above the breakpoint and per-piece below the breakpoint) as shown in column (i) of Table 1. Id. at 2. The Postal Service says this calculation now divides the entire value of the dropship discount, both per piece and per pound, by the total avoided cost. While the denominator can be expressed as either the total avoided cost per piece times the total number of pieces or the total avoided cost per pound times the total number of pounds, Table 1 opts for the former alternative, cost per piece times the total number of pieces [(f) × [(a) + (b)]]. Id.

Impacts. The Postal Service states that the proposed methodology could provide a more accurate representation of passthroughs to ensure discounts do not exceed the Postal Service cost avoided as a result of dropshipping. Id. Under the proposal, one passthrough reported in the FY 2016 Annual Compliance Report would have increased from 75.7 percent to 111.0 percent.3 If adopted, the Postal Service would seek to reset the passthrough at 100 percent or less in the next market dominant price adjustment proceeding or cite a statutory exception. Petition, Proposal Seven at 2-3.

3Id.; see Petition, Excel file “Prop.7.Dropship_Passthroughs.xlsx,” columns (h) and (i).

III. Notice and Comment

The Commission establishes Docket No. RM2017-11 for consideration of matters raised by the Petition. More information on the Petition may be accessed via the Commission's Web site at http://www.prc.gov. Interested persons may submit comments on the Petition and Proposal Seven no later than September 15, 2017. Pursuant to 39 U.S.C. 505, Katalin K. Clendenin is designated as officer of the Commission (Public Representative) to represent the interests of the general public in this proceeding.

IV. Ordering Paragraphs

It is ordered:

1. The Commission establishes Docket No. RM2017-11 for consideration of the matters raised by the Petition of the United States Postal Service for the Initiation of a Proceeding to Consider Proposed Changes in Analytical Principles (Proposal Seven), filed July 28, 2017.

2. Comments by interested persons in this proceeding are due no later than September 15, 2017.

3. Pursuant to 39 U.S.C. 505, the Commission appoints Katalin K. Clendenin to serve as an officer of the Commission (Public Representative) to represent the interests of the general public in this docket.

4. The Secretary shall arrange for publication of this order in the Federal Register.

By the Commission.

Stacy L. Ruble, Secretary.
[FR Doc. 2017-16543 Filed 8-4-17; 8:45 am] BILLING CODE 7710-FW-P
POSTAL REGULATORY COMMISSION 39 CFR part 3050 [Docket No. RM2017-10; Order No. 4023] Periodic Reporting AGENCY:

Postal Regulatory Commission.

ACTION:

Notice of proposed rulemaking.

SUMMARY:

The Commission is announcing a recent filing requesting that the Commission initiate an informal rulemaking proceeding to consider changes to an analytical method for use in periodic reporting (Proposal Six). This document informs the public of the filing, invites public comment, and takes other administrative steps.

DATES:

Comments are due: September 15, 2017.

ADDRESSES:

Submit comments electronically via the Commission's Filing Online system at http://www.prc.gov. Those who cannot submit comments electronically should contact the person identified in the FOR FURTHER INFORMATION CONTACT section by telephone for advice on filing alternatives.

FOR FURTHER INFORMATION CONTACT:

David A. Trissell, General Counsel, at 202-789-6820.

SUPPLEMENTARY INFORMATION: Table of Contents I. Introduction II. Proposal Six III. Notice and Comment IV. Ordering Paragraphs I. Introduction

On July 28, 2017, the Postal Service filed a petition pursuant to 39 CFR 3050.11 requesting the Commission to initiate an informal rulemaking proceeding to consider proposed changes to an analytical method related to periodic reports.1 The Petition identifies the proposed analytical method changes filed in this docket as Proposal Six.

1 Petition of the United States Postal Service for the Initiation of a Proceeding to Consider Proposed Changes in Analytical Principles (Proposal Six), July 28, 2017 (Petition).

II. Proposal Six

Background. In January 2016, the Postal Service removed the originating network distribution center and network distribution center presort price categories for Parcel Select and the return network distribution center price category for Parcel Return Service (PRS). Petition, Proposal Six at 1. The Postal Service states that “[d]uring the process of modifying these models to remove the portions of the cost studies related to the discontinued price categories, the Postal Service detected some minor errors that required correction.” Id. The Postal Service conducted a review of these models to “ensure that they reflected current processing methods” and determine if new data could be incorporated. Id.

Proposal. The Postal Service seeks to revise the mail processing and transportation cost models for Parcel Select and PRS mail. The proposed changes update the cost models, correct errors, incorporate new data, and re-evaluate some assumptions and methodologies.

Impact. The Postal Service estimates that its proposed changes will result in adjustments to both its mail processing and transportation models for Parcel Select and PRS mail.

For mail processing costs, the revisions will decrease Parcel Select Ground Machinable unit cost estimates by 3.4 percent. Petition, Proposal Six at 15, 18. The proposed changes will result in six adjustments to PRS mail processing costs, including a decrease of more than 30 percent in return delivery unit oversize costs. Id.

The transportation cost adjustments incorporate methodology changes approved by the Commission in Order No. 3973 2 with the cost model changes the Postal Service proposes in this docket. The resulting Parcel Select cost decreases range from 6.4 to 94.6 percent. Petition, Proposal Six at 15-16, 19. Additionally, the transportation cost for destination sectional center facility rates will increase by 193 percent. Id. at 16, 19. The PRS costs for return sectional center facility will decrease by almost 26 percent. Id.

2 Docket No. RM2016-12, Order on Analytical Principles Used in Periodic Reporting (Proposal Four), June 22, 2017 (Order No. 3973).

III. Notice and Comment

The Commission establishes Docket No. RM2017-10 for consideration of matters raised by the Petition. More information on the Petition may be accessed via the Commission's Web site at http://www.prc.gov. Interested persons may submit comments on the Petition and Proposal Six no later than September 15, 2017. Pursuant to 39 U.S.C. 505, Lyudmila Y. Bzhilyanskaya is designated as officer of the Commission (Public Representative) to represent the interests of the general public in this proceeding.

IV. Ordering Paragraphs

It is ordered:

1. The Commission establishes Docket No. RM2017-10 for consideration of the matters raised by the Petition of the United States Postal Service for the Initiation of a Proceeding to Consider Proposed Changes in Analytical Principles (Proposal Six), filed July 28, 2017.

2. Comments by interested persons in this proceeding are due no later than September 15, 2017.

3. Pursuant to 39 U.S.C. 505, the Commission appoints Lyudmila Y. Bzhilyanskaya to serve as an officer of the Commission (Public Representative) to represent the interests of the general public in this docket.

4. The Secretary shall arrange for publication of this order in the Federal Register.

By the Commission.

Stacy L. Ruble, Secretary.
[FR Doc. 2017-16517 Filed 8-4-17; 8:45 am] BILLING CODE 7710-FW-P
ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R04-OAR-2016-0462; FRL-9965-68-Region 4] Air Plan Approval; Kentucky; Regional Haze Progress Report AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Proposed rule.

SUMMARY:

The Environmental Protection Agency (EPA) is proposing to approve a State Implementation Plan (SIP) revision submitted by the Commonwealth of Kentucky through the Kentucky Energy and Environment Cabinet, Division of Air Quality (KDAQ) on September 17, 2014. Kentucky's September 17, 2014, SIP revision (Progress Report) addresses requirements of the Clean Air Act (CAA or Act) and EPA's rules that require each state to submit periodic reports describing progress towards reasonable progress goals (RPGs) established for regional haze and a determination of the adequacy of the state's existing SIP addressing regional haze (regional haze plan). EPA is proposing to approve Kentucky's determination that the Commonwealth's regional haze plan is adequate to meet these RPGs for the first implementation period covering through 2018 and requires no substantive revision at this time.

DATE:

Comments must be received on or before September 6, 2017.

ADDRESSES:

Submit your comments, identified by Docket ID No. EPA-R04-OAR-2016-0462 at http://www.regulations.gov. Follow the online instructions for submitting comments. Once submitted, comments cannot be edited or removed from Regulations.gov. EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. EPA will generally not consider comments or comment contents located outside of the primary submission (i.e., on the web, cloud, or other file sharing system). For additional submission methods, 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:

Michele Notarianni, Air Regulatory Management Section, Air Planning and Implementation Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia 30303-8960. Ms. Notarianni can be reached by phone at (404) 562-9031 and via electronic mail at [email protected]

SUPPLEMENTARY INFORMATION:

I. Background

States are required to submit a progress report in the form of a SIP revision that evaluates progress towards the RPGs for each mandatory Class I federal area 1 (Class I area) within the state and for each Class I area outside the state which may be affected by emissions from within the state. 40 CFR 51.308(g). In addition, the provisions of 40 CFR 51.308(h) require states to submit, at the same time as the 40 CFR 51.308(g) progress report, a determination of the adequacy of the state's existing regional haze plan. The progress report is due five years after submittal of the initial regional haze plan. Kentucky submitted its regional haze plan on June 25, 2008, as later amended in a SIP revision submitted on May 28, 2010.2

1 Areas designated as mandatory Class I federal areas consist of national parks exceeding 6000 acres, wilderness areas and national memorial parks exceeding 5000 acres, and all international parks that were in existence on August 7, 1977 (42 U.S.C. 7472(a)). Listed at 40 CFR part 81 Subpart D.

2 Throughout this document, references to Kentucky's “regional haze plan” refer to Kentucky's original June 25, 2008, regional haze SIP submittal, as later amended in a SIP revision submitted on May 28, 2010.

Like many other states subject to the Clean Air Interstate Rule (CAIR), Kentucky relied on CAIR in its regional haze plan to meet certain requirements of EPA's Regional Haze Rule, including best available retrofit technology (BART) requirements for emissions of sulfur dioxide (SO2) and nitrogen oxides (NOX) from certain electric generating units (EGUs) in the Commonwealth.3 This reliance was consistent with EPA's regulations at the time that Kentucky developed its regional haze plan. See 70 FR 39104 (July 6, 2005). However, in 2008, the United States Court of Appeals for the District of Columbia Circuit (D.C. Circuit) remanded CAIR to EPA without vacatur to preserve the environmental benefits provided by CAIR. North Carolina v. EPA, 550 F.3d 1176, 1178 (D.C. Cir. 2008). On August 8, 2011 (76 FR 48208), acting on the D.C. Circuit's remand, EPA promulgated the Cross-State Air Pollution Rule (CSAPR) to replace CAIR and issued Federal Implementation Plans (FIPs) to implement the rule in CSAPR-subject states.4 Implementation of CSAPR was scheduled to begin on January 1, 2012, when CSAPR would have superseded the CAIR program. However, numerous parties filed petitions for review of CSAPR, and at the end of 2011, the D.C. Circuit issued an order staying CSAPR pending resolution of the petitions and directing EPA to continue to administer CAIR. Order of December 30, 2011, in EME Homer City Generation, L.P. v. EPA, D.C. Cir. No. 11-1302.

3 CAIR required certain states, including Kentucky, to reduce emissions of SO2 and NOX that significantly contribute to downwind nonattainment of the 1997 National Ambient Air Quality Standard (NAAQS) for fine particulate matter (PM2.5) and ozone. See 70 FR 25162 (May 12, 2005).

4 CSAPR requires substantial reductions of SO2 and NOX emissions from EGUs in 28 states in the Eastern United States that significantly contribute to downwind nonattainment of the 1997 PM2.5 and ozone NAAQS and 2006 PM2.5 NAAQS.

On March 30, 2012, EPA finalized a limited approval of Kentucky's regional haze plan as meeting some of the applicable regional haze requirements as set forth in sections 169A and 169B of the CAA and in 40 CFR 51.300-308. Also in this March 30, 2012, action, EPA finalized a limited disapproval of Kentucky's regional haze plan because of deficiencies arising from the Commonwealth's reliance on CAIR to satisfy certain regional haze requirements. See 77 FR 19098. On June 7, 2012, EPA promulgated FIPs to replace reliance on CAIR with reliance on CSAPR to address deficiencies in CAIR-dependent regional haze plans of several states, including Kentucky's regional haze plan. See 77 FR 33642. Following additional litigation and the lifting of the stay, EPA began implementation of CSAPR on January 1, 2015.

On September 17, 2014, Kentucky submitted its Progress Report which, among other things, detailed the progress made in the first period toward implementation of the long term strategy outlined in the Commonwealth's regional haze plan; the visibility improvement measured at Mammoth Cave National Park (Mammoth Cave), the only Class I area within Kentucky, and at Class I areas outside of the Commonwealth potentially impacted by emissions from Kentucky; and a determination of the adequacy of the Commonwealth's existing regional haze plan. EPA is proposing to approve Kentucky's September 17, 2014, Progress Report for the reasons discussed below.

II. EPA's Evaluation of Kentucky's Progress Report and Adequacy Determination A. Regional Haze Progress Report

This section includes EPA's analysis of Kentucky's Progress Report, and an explanation of the basis for the Agency's proposed approval.

1. Control Measures

In its Progress Report, Kentucky summarizes the status of the emissions reduction measures that were relied upon by Kentucky in its regional haze plan and included in the final iteration of the Visibility Improvement State and Tribal Association of the Southeast (VISTAS) regional haze emissions inventory and RPG modeling used by the Commonwealth in developing its regional haze plan. The measures include, among other things, applicable Federal programs (e.g., mobile source rules, Maximum Achievable Control Technology standards), Federal consent agreements, and Federal control strategies for EGUs. Kentucky also reviewed the status of BART requirements for the five BART-subject sources for particulate matter (PM) in the Commonwealth—American Electric Power (AEP) Big Sandy Plant, E.ON U.S Mill Creek Station, East Kentucky Power Cooperative (EKPC) Cooper Station, EKPC Spurlock Station, and Tennessee Valley Authority (TVA) Paradise Plant—and described the court decisions addressing CAIR and CSAPR at the time of progress report development.5

5 Kentucky Progress Report, pp. 33-35.

As discussed above, a number of states, including Kentucky, submitted regional haze SIPs that relied on CAIR to meet certain regional haze requirements. EPA finalized a limited disapproval of Kentucky's regional haze plan due to this reliance and promulgated a FIP to replace the Commonwealth's reliance on CAIR with reliance on CSAPR. Although a number of parties challenged the legality of CSAPR and the D.C. Circuit initially vacated and remanded CSAPR to EPA in EME Homer City Generation, L.P. v. EPA, 696 F.3d 7 (D.C. Cir. 2012), the United States Supreme Court reversed the D.C. Circuit's decision on April 29, 2014, and remanded the case to the D.C. Circuit to resolve remaining issues in accordance with the high court's ruling. EPA v. EME Homer City Generation, L.P., 134 S. Ct. 1584 (2014). On remand, the D.C. Circuit affirmed CSAPR in most respects, and CSAPR is now in effect. EME Homer City Generation, L.P. v. EPA, 795 F.3d 118 (D.C. Cir. 2015). Kentucky notes in its Progress Report that it has an EPA-approved CAIR SIP and that CAIR was in effect at the time of Progress Report submittal due to the 2011 CSAPR stay. Because CSAPR should result in greater emissions reductions of SO2 and NOX than CAIR throughout the affected region, EPA expects Kentucky to maintain and continue its progress towards its RPGs for 2018 through continued, and additional, SO2 and NOX reductions. See generally 76 FR 48208 (August 8, 2011).

The Commonwealth also discusses in its Progress Report the status of several measures that were not included in the final VISTAS emissions inventory and were not relied upon in the initial regional haze plan to meet RPGs. These measures include EPA's Mercury and Air Toxics Rule, three Federal consent decrees, and planned retirements and fuel switching at several EGUs in Kentucky. The Commonwealth notes that the emissions reductions from these measures will help ensure that Class I areas impacted by Kentucky sources achieve their RPGs.

In its regional haze plan and Progress Report, Kentucky focuses its assessment on SO2 emissions from EGUs because of VISTAS' findings that ammonium sulfate accounted for 69-87 percent of the visibility-impairing pollution in the VISTAS states and roughly 82 percent of the visibility-impairing pollution at Mammoth Cave National Park on the 20 percent worst visibility days. Although Kentucky determined in its regional haze plan that no additional controls for sources in the Commonwealth were needed to make reasonable progress for SO2 during the first implementation period,6 Kentucky's Progress Report identifies the control status of eight out-of-state EGUs, six from Indiana and two from Tennessee, located in the area of influence of Kentucky's Class I area using the Commonwealth's methodology for determining sources eligible for a reasonable progress control determination. Because these eight EGUs were subject to CAIR and Mammoth Cave National Park was projected to exceed the uniform rate of progress during the first implementation period, KDAQ opted not to request from Indiana and Tennessee any additional emissions reductions for reasonable progress for the first implementation period.7 Kentucky's Progress Report indicates that SO2 emissions from these eight out-of-state EGUs have decreased by nearly 50 percent from 2002 to 2012.

6See 76 FR 78204.

7See 76 FR 78213 and Kentucky Progress Report, p. 37.

In addition, the Commonwealth provides an update on the control status of EGUs in Kentucky identified by Maine, New Jersey, New Hampshire, and Vermont as contributing to visibility impairment at Class I areas located in those states based on 2002 emissions. These states are members of the Mid-Atlantic/Northeast Visibility Union (MANE-VU), which identified 167 EGU “stacks,” 10 of which are in Kentucky, as contributing significantly to visibility impairment at MANE-VU Class I areas in 2002. The 10 EGU stacks are located at: Duke Energy's East Bend plant; EKPC's Cooper and Spurlock plants; AEP Big Sandy plant; E.ON U.S. E.W. Brown, Ghent, and Mill Creek plants; and TVA Paradise. MANE-VU asked Kentucky to control the SO2 emissions from these EGUs with a 90 percent control efficiency and to adopt a control strategy to provide a 28 percent reduction in SO2 emissions from non-EGU emission sources that would be equivalent to MANE-VU's proposed low sulfur residential fuel oil strategy.

In its Progress Report, the Commonwealth notes that the Kentucky EGUs identified by MANE-VU either have or will have scrubbers with a minimum SO2 control efficiency of 90 percent or are scheduled for retirement by 2018. Kentucky also notes that there was a decrease of 196,753 tons in SO2 emissions from 2002 to 2012 8 at these EGUs and that planned retirements at these EGUs will result in an additional SO2 emissions decrease of 30,845 tons by 2018 from these units.

8 Kentucky Progress Report, Table 15, pp.62-65. The emissions reductions are based on data from EPA's Clean Air Markets Division provided in the Progress Report.

EPA proposes to find that Kentucky has adequately addressed the applicable provisions under 40 CFR 51.308(g) regarding the implementation status of control measures because the Commonwealth described the implementation of measures within Kentucky, including BART at BART-subject sources for PM.

2. Emissions Reductions

As discussed above, Kentucky focused its assessment in its regional haze plan and Progress Report on SO2 emissions from EGUs because of VISTAS' findings that ammonium sulfate is the primary component of visibility-impairing pollution in the VISTAS states. In its Progress Report, Kentucky provides SO2 emissions data from EPA's Clean Air Markets Division (CAMD) for each coal-fired EGU in the Commonwealth. Actual SO2 emissions reductions from 2002 to 2012 for these Kentucky EGUs (300,335 tons) have already exceeded the projected SO2 emissions reductions from 2002 to 2018 estimated in Kentucky's regional haze plan for these EGUs (261,234 tons).9 Kentucky also includes cumulative SO2 and NOX CAMD emissions data from 2002-2012 for EGUs in the Commonwealth subject to reporting under the Acid Rain Program. This data shows a decline in these emissions over this time period and shows that the SO2 reductions are greater than those estimated for these units between 2002-2018 in the Commonwealth's regional haze plan. The emissions reductions identified by Kentucky are due, in part, to the implemenation of measures included in the Commonwealth's regional haze plan (e.g., CAIR).

9 Kentucky Progress Report, Table 14, pp. 53-60.

EPA proposes to find that Kentucky has adequately addressed the applicable provisions of 40 CFR 51.308(g) regarding emissions reductions because the Commonwealth identifies SO2 emissions reductions from EGUs in Kentucky, the largest sources of SO2 emissions in the Commonwealth.

3. Visibility Conditions

The provisions under 40 CFR 51.308(g) require that states with Class I areas within their borders provide information on current visibility conditions and the difference between current visibility conditions and baseline visibility conditions expressed in terms of five-year averages of these annual values.

Kentucky's Progress Report provides figures with visibility monitoring data for Mammoth Cave. Kentucky reported current visibility conditions as both the 2006-2010 and 2009-2013 five-year time periods and used the 2000-2004 baseline period for its Class I area.10 Table 1, below, shows the visibility conditions for both the 2006-2010 and 2009-2013 five-year time periods and the difference between these current visibility conditions and baseline visibility conditions.

10 For the first regional haze plans, “baseline” conditions were represented by the 2000-2004 time period. See 64 FR 35730 (July 1, 1999).

Table 1—Baseline Visibility, Current Visibility, and Visibility Changes in Kentucky's Class I Area [deciviews] Class I area Baseline
  • (2000-2004)
  • Current
  • (2006-2010)
  • Difference More current
  • (2009-2013)
  • Difference
    20% Worst Days Mammoth Cave National Park 31.37 29.09 −2.28 25.09 −6.28 20% Best Days Mammoth Cave National Park 16.51 15.41 −1.10 13.69 −2.82

    As shown in Table 1, Mammoth Cave saw an improvement in visibility between baseline and the 2006-2010 and 2009-2013 time periods.11 Kentucky also reported 20 percent worst day and 20 percent best day visibility data for Mammoth Cave from 2006-2013 for each year in terms of five-year averages.12 This data shows an improvement in visibility at Mammoth Cave on the 20 percent best days from 2006-2013 and on the 20 percent worst days from 2007-2013.

    11 Kentucky Progress Report, Tables 17 and 18, pp. 67-68.

    12 Kentucky Progress Report, Table 18, p.68.

    EPA notes that Kentucky's original RPGs were based on the VISTAS modeling run available at the time of Kentucky's June 25, 2008, regional haze plan. In 2008, VISTAS provided updated modeling results that changed the modeled progress for Kentucky's Class I area. Table 2 identifies the RPGs for Mammoth Cave in the Commonwealth's regional haze plan and provides, for comparison purposes only, the updated RPGs provided by VISTAS.13

    13 Kentucky Progress Report, Table 16, p. 66.

    Table 2—Updated RPGs for Kentucky's Class I Area [deciviews] Class I area Mammoth Cave National Park RPG 20% worst days RPG 20% best days Original RPGs 25.56 15.57 Updated RPGs 25.40 15.42

    EPA proposes to find that Kentucky has adequately addressed the applicable provisions under 40 CFR 51.308(g) regarding visibility conditions because the Commonwealth provided baseline visibility conditions (2000-2004), current conditions based on the most recently available visibility monitoring data available at the time of Progress Report development, the difference between these current sets of visibility conditions and baseline visibility conditions, and the change in visibility impairment from 2006-2013.

    4. Emissions Tracking

    In its Progress Report, Kentucky presents data from a statewide actual emissions inventory for 2007 and compares this data to the baseline emissions inventory for 2002 (actual and typical emissions).14 The pollutants inventoried include VOC, NH3, NOX, PM2.5, coarse particulate matter (PM10), and SO2. The emissions inventories include the following source classifications: point, area, fires, non-road mobile, and on-road mobile sources. As discussed in Section II.A.2, above, Kentucky also presented NOX and SO2 data from 2002-2012 for EGUs in Kentucky.

    14 For the typical 2002 stationary point source emissions inventory, the EGU emissions are adjusted for a typical year so that if sources were shut down or are operating above or below normal, the emissions are normalized to a typical emissions inventory year. The typical year data is used to develop projected typical future year emissions inventories.

    Kentucky estimated on-road mobile source emissions in the 2007 inventory using EPA's MOVES model. This model tends to estimate higher emissions for NOX and PM than its previous counterpart, EPA's MOBILE6.2 model, used by the Commonwealth to estimate on-road mobile source emissions for the 2002 inventories. Despite the change in methodology, with the exception of a slight increase in PM2.5 and PM10, 2007 actual emissions are lower for all inventoried emissions than both the actual and typical 2002 emissions, as can be seen when comparing Tables 3 and 4 to Table 5.

    Table 3—2002 Actual Emissions Inventory Summary for Kentucky [tpy] Source category NH 3 NOX PM10 PM2.5 SO2 VOC Point 1,000 237,209 21,326 14,173 518,086 46,321 Area 51,135 39,507 233,559 45,453 41,805 95,375 On-Road Mobile 5,055 156,417 3,723 2,697 6,308 103,503 Non-Road Mobile 31 104,571 6,425 6,046 14,043 44,805 Fires 44 1,142 5,226 5,074 49 2,640 Total 57,265 538,846 270,259 73,443 580,291 292,644 Table 4—2002 Typical Emissions Inventory Summary for Kentucky [tpy] Source category NH 3 NOX PM10 PM2.5 SO2 VOC Point 995 240,362 21,421 14,219 529,182 46,315 Area 51,135 39,507 233,559 45,453 41,805 95,375 On-Road Mobile 5,055 156,417 3,723 2,697 6,308 103,503 Non-Road Mobile 31 104,517 6,425 6,046 14,043 44,805 Fires 110 1,460 6,667 6,310 136 3,338 Total 57,326 542,317 271,795 74,725 591,474 293,336 Table 5—2007 Actual Emissions Inventory Summary for Kentucky [tpy] Source category  NH3 NOX PM10 PM2.5 SO2 VOC Point 113 210,213 30,678 21,110 410,413 47,679 Area 52,332 12,693 226,829 40,341 15,590 75,100 On-Road Mobile 2,172 133,425 5,524 4,363 1,022 55,883 Non-Road Mobile 46 63,454 4,207 3,969 3,037 38,785 Fires 138 1,377 5,016 4,678 180 2,939 Total 54,801 421,163 272,254 74,461 430,242 220,386

    EPA is proposing to find that Kentucky adequately addressed the provisions of 40 CFR 51.308(g) regarding emissions tracking because the Commonwealth compared the most recent updated emission inventory data available at the time of Progress Report development with the baseline emissions used in the modeling for the regional haze plan. Furthermore, Kentucky evaluated available CAMD SO2 emissions data from 2002 to 2012 for Kentucky EGUs because this data was available at the time of Progress Report development, ammonium sulfate is the primary component of visibility-impairing pollution in the VISTAS states, and EGUs are the largest source of SO2 in the Commonwealth.

    5. Assessment of Changes Impeding Visibility Progress

    In its Progress Report, Kentucky documented that sulfates, which are formed from SO2 emissions, continue to be the biggest single contributor to regional haze for Class I areas in the Commonwealth and therefore focused its analysis on large SO2 emissions from point sources. In addressing the requirements at 40 CFR 51.308(g)(5), Kentucky demonstrates that sulfate contributions to visibility impairment have decreased overall from 2000 to 2013 15 along with an improvement in visibility, and examines other potential pollutants of concern affecting visibility at Mammoth Cave. The Commonwealth presents data for the 20 percent worst days showing that ammonium sulfate is responsible for 79.6 and 67.8 percent of the regional haze at Mammoth Cave for the periods 2006-2010 and 2009-2013, respectively. For 2006-2010, primary organic matter is the next largest contributor at 9.3 percent whereas for 2009-2013, the next largest contributor to regional haze is ammonium nitrate at 13.9 percent, followed by primary organic matter at 11.7 percent. Furthermore, the Progress Report shows that the Commonwealth is on track to meeting its 2018 RPGs for Mammoth Cave and that SO2 emissions reductions from 2002-2012 for EGUs in Kentucky have exceeded the projected reductions from 2002-2018 in the regional haze plan.

    15 Kentucky Progress Report, Figures 21 and 22, p. 80.

    EPA proposes to find that Kentucky has adequately addressed the provisions of 40 CFR 51.308(g) regarding an assessment of significant changes in anthropogenic emissions. EPA preliminarily agrees with Kentucky's conclusion that there have been no significant changes in emissions of visibility-impairing pollutants which have limited or impeded progress in reducing emissions and improving visibility in Class I areas impacted by the Commonwealth's sources.

    6. Assessment of Current Strategy

    The Commonwealth believes that it is on track to meet the 2018 RPGs for Mammoth Cave and will not impede Class I areas outside of Kentucky from meeting their RPGs based on the trends in visibility and emissions presented in its Progress Report. Kentucky notes that the IMPROVE visibility readings for 2009-2013 already show greater improvments in visibility than projected by Kentucky in establishing the 2018 RPGs for Mammoth Cave and that SO2 emissions from coal-fired EGUs in the Commonwealth have fallen from 2002 to 2012 by more than than the predicted decline in SO2 emissions from these sources for the first planning period in Kentucky's regional haze plan. Kentucky expects that these emissions will continue to decrease through the first regional haze implementation period. The Commonwealth identifies additional SO2 reductions of 49,649 tpy from Kentucky EGUs that are retiring or converting to natural gas which were not accounted for in the original 2018 emissions projections in its regional haze plan.16 Kentucky also provides data showing that SO2 emissions from 2002 to 2012 from EGUs outside of the Commonwealth impacting visibility at Mammoth Cave have decreased by nearly 49 percent (65,416 tpy). In addition, the Commonwealth provides emissions data in Table 13 and in Figures 10 and 12 of its Progress Report showing a declining trend in SO2 and NOX emissions from 2002 to 2012 for EGUs in Kentucky and the VISTAS states.

    16 Kentucky Progress Report, Table 11, pp. 42-43.

    Kentucky also provides updated visibility analyses for Mammoth Cave and the Class I areas outside the Commonwealth potentially impacted by sources in Kentucky (Great Smoky Mountains National Park in North Carolina and Tennessee, James River Face Wilderness Area and Shenandoah National Park in Virginia, Linville Gorge Wilderness Area in North Carolina, and Dolly Sods Wilderness Area in West Virginia), and notes that these analyses show that these areas are on track to achieve their RPGs by 2018.17

    17 Kentucky Progress Report, Table 26, p. 87; Figures 23-32, pp. 82-86; Figures 14 and 15, pp. 69-70.

    As discussed in Section II.A.1, above, CAIR was implemented during the time period evaluated by Kentucky for its Progress Report, but has now been replaced by CSAPR. At the present time, the requirements of CSAPR apply to sources in Kentucky under the terms of a FIP because Kentucky has not, to date, incorporated the CSAPR requirements into its SIP. Kentuky's regional haze plan accordingly does not contain sufficient provisions to ensure that the RPGs of Class I areas in nearby states will be achieved. The term “implementation plan,” however, is defined for purposes of the Regional Haze Rule to mean “any [SIP], [FIP], or Tribal Implementation Plan.” 40 CFR 51.301. Measures in any issued FIP, as well as those in a state's regional haze SIP, may therefore be considered in assessing the adequacy of the “existing implementation plan.”

    EPA proposes to find that Kentucky has adequately addressed the provisions of 40 CFR 51.308(g) regarding the strategy assessment. In its Progress Report, Kentucky described the improving visibility trends using data from the IMPROVE network and the downward emissions trends in key pollutants, with a focus on SO2 emissions from EGUs in the Commonwealth. Kentucky determined that its regional haze plan is sufficient to meet the RPGs for its own Class I area and the Class I areas outside the Commonwealth potentially impacted by the emissions from Kentucky. EPA finds that Kentucky's conclusion regarding the sufficiency of its regional haze plan is appropriate because CAIR was in effect in Kentucky through 2014, providing the emission reductions relied upon in Kentucky's regional haze plan through that date. CSAPR is now being implemented, and by 2018, the end of the first regional haze implementation period, CSAPR will reduce emissions of SO2 and NOX from EGUs in Kentucky by the same amount assumed by EPA when it issued the FIP for the Commonwealth in June 2012 replacing reliance on CAIR with reliance on CSAPR. Because CSAPR will ensure the control of SO2 and NOX emissions reductions relied upon by Kentucky and other states in setting their RPGs beginning in January 2015 at least through the remainder of the first implementation period in 2018, EPA is proposing to approve Kentucky's finding that the plan elements and strategies in its implementation plan are sufficient to achieve the RPGs for the Class I area in the Commonwealth and for Class I areas in nearby states potentially impacted by sources in the Commonwealth.

    7. Review of Current Monitoring Strategy

    In its Progress Report, Kentucky summarizes the existing monitoring network in Kentucky to monitor visibility at Mammoth Cave and concludes that no modifications to the existing visibility monitoring strategy are necessary. The primary monitoring network for regional haze, both nationwide and in Kentucky, is the Interagency Monitoring of Protected Visual Environments (IMPROVE) network. There is currently one IMPROVE site located in Mammoth Cave National Park.

    The Commonwealth also explains the importance of the IMPROVE monitoring network for tracking visibility trends at the Class I area in Kentucky. Kentucky states that data produced by the IMPROVE monitoring network will be used nearly continuously for preparing the regional haze progress reports and SIP revisions, and thus, the monitoring data from the IMPROVE sites needs to be readily accessible and to be kept up to date. The Visibility Information Exchange Web System Web site has been maintained by VISTAS and the other Regional Planning Organizations to provide ready access to the IMPROVE data and data analysis tools.

    In addition to the IMPROVE measurements, some ongoing long-term limited monitoring supported by Federal Land Managers provides additional insight into progress toward regional haze goals. Kentucky benefits from the data from these measurements, but is not responsible for associated funding decisions to maintain these measurements into the future.

    In addition, KDAQ operates a PM2.5 network of filter-based Federal reference method monitors and filter-based speciation monitors. These PM2.5 measurements help the KDAQ characterize air pollution levels in areas across the Commonwealth, and therefore aid in the analysis of visibility improvement in and near Mammoth Cave.

    EPA proposes to find that Kentucky has adequately addressed the applicable provisions of 40 CFR 51.308(g) regarding monitoring strategy because the Commonwealth reviewed its visibility monitoring strategy and determined that no further modifications to the strategy are necessary.

    B. Determination of Adequacy of the Existing Regional Haze Plan

    In its Progress Report, Kentucky submitted a negative declaration to EPA regarding the need for additional actions or emissions reductions in Kentucky beyond those already in place and those to be implemented by 2018 according to Kentucky's regional haze plan. Kentucky determined that the existing regional haze plan requires no further substantive revision at this time to achieve the RPGs for Class I areas affected by the Commonwealth's sources. The Commonwealth's negative declaration is based on the findings from the Progress Report, including the findings that: visibility has already improved at Mammoth Cave in Kentucky such that monitored 2009-2013 visibility readings show that the Class I area has already met its RPGs for 2018; actual SO2 emissions reductions from coal-fired EGUs in Kentucky exceed the predicted reductions in Kentucky's regional haze plan; additional EGU control measures not relied upon in the Commonwealth's regional haze plan have occurred or will occur during the first implementation period that will further reduce SO2 emissions; and emissions of SO2 from EGUs in Kentucky and the surrounding VISTAS states are expected to continue to trend downward.

    EPA proposes to conclude that Kentucky has adequately addressed 40 CFR 51.308(h) because the visibility trends at Mammoth Cave and at Class I areas outside of the Commonwealth potentially impacted by sources within Kentucky and the emissions trends of the largest emitters of visibility-impairing pollutants in the Commonwealth indicate that the relevant RPGs will be met.

    III. Proposed Action

    EPA is proposing to approve Kentucky's September 17, 2014, Regional Haze Progress Report as meeting the applicable regional haze requirements set forth in 40 CFR 51.308(g) and 51.308(h).

    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 Act and applicable federal regulations. See 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 proposed action merely proposes to approve state law as meeting federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this proposed action:

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

    • 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).

    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 as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it impose substantial direct costs on tribal governments or preempt tribal law.

    List of Subjects in 40 CFR Part 52

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

    Authority:

    42 U.S.C. 7401 et seq.

    Dated: July 25, 2017. V. Anne Heard, Acting Regional Administrator, Region 4.
    [FR Doc. 2017-16484 Filed 8-4-17; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 63 [EPA-HQ-OAR-2012-0360; FRL-9965-18-OAR] RIN 2060-AT48 National Emission Standards for Hazardous Air Pollutants: Off-Site Waste and Recovery Operations AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Proposed rule.

    SUMMARY:

    This action proposes amendments to the National Emission Standards for Hazardous Air Pollutants (NESHAP) for Off-Site Waste and Recovery Operations (OSWRO). The proposed amendments address an issue related to monitoring pressure relief devices (PRDs) on containers. This issue was raised in a petition for reconsideration of the amendments to the OSWRO NESHAP finalized in 2015 based on the residual risk and technology review (RTR). Among other things, the 2015 amendments established additional monitoring requirements for all PRDs, including PRDs on containers. For PRDs on containers, these monitoring requirements were in addition to the inspection and monitoring requirements for containers and their closure devices, which include PRDs that were already required by the OSWRO NESHAP. This proposed action would remove the additional monitoring requirements for PRDs on containers that resulted from the 2015 amendments because we have determined that they are not necessary. This action, if finalized as proposed, would not substantially change the level of environmental protection provided under the OSWRO NESHAP. The proposed amendments would reduce capital costs related to compliance to this industry by $28 million compared to the current rule. Total annualized costs, at an interest rate of 7 percent, would be reduced by $4.2 million per year. These costs are associated with a present value of $39 million dollars, discounted at 7 percent over 15 years.

    DATES:

    Comments. Comments must be received on or before September 21, 2017.

    Public Hearing. If a public hearing is requested by August 14, 2017, then we will hold a public hearing on August 22, 2017 at the location described in the ADDRESSES section. The last day to pre-register in advance to speak at the public hearing will be August 21, 2017.

    ADDRESSES:

    Comments. Submit your comments, identified by Docket ID No. EPA-HQ-OAR-2012-0360 at http://www.regulations.gov. Follow the online instructions for submitting comments. Once submitted, comments cannot be edited or removed from http://www.regulations.gov. The U.S. Environmental Protection Agency (EPA) may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission (i.e., on the Web, cloud, or other file sharing system). For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit http://www.epa.gov/dockets/commenting-epa-dockets.

    Public Hearing. If a public hearing is requested, it will be held at EPA Headquarters, William Jefferson Clinton East Building, 1201 Constitution Avenue NW., Washington, DC 20004. If a public hearing is requested, then we will provide details about the public hearing on our Web site at: https://www.epa.gov/stationary-sources-air-pollution/site-waste-and-recovery-operations-oswro-national-emission. The EPA does not intend to publish another document in the Federal Register announcing any updates on the request for a public hearing. Please contact Ms. Virginia Hunt at (919) 541-0832 or by email at [email protected] to request a public hearing, to register to speak at the public hearing, or to inquire as to whether a public hearing will be held.

    FOR FURTHER INFORMATION CONTACT:

    For questions about this proposed action, please contact Ms. Angie Carey, Sector Policies and Programs Division (E143-01), Office of Air Quality Planning and Standards, U.S. Environmental Protection Agency, Research Triangle Park, North Carolina 27711; telephone number: (919) 541-2187; fax number: (919) 541-0246; email address: [email protected] For information about the applicability of the NESHAP to a particular entity, contact Ms. Marcia Mia, Office of Enforcement and Compliance Assurance, U.S. Environmental Protection Agency, EPA WJC South Building, Mail Code 2227A, 1200 Pennsylvania Avenue NW., Washington, DC 20460; telephone number: (202) 564-7042; fax number: (202) 564-0050; and email address: [email protected]

    SUPPLEMENTARY INFORMATION:

    Docket. The EPA has established a docket for this rulemaking under Docket ID No. EPA-HQ-OAR-2012-0360. All documents in the docket are listed in the http://www.regulations.gov index. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy. Publicly available docket materials are available either electronically in http://www.regulations.gov or in hard copy at the EPA Docket Center, Room 3334, EPA WJC West Building, 1301 Constitution Avenue NW., Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the EPA Docket Center is (202) 566-1742.

    Instructions: Direct your comments to Docket ID No. EPA-HQ-OAR-2012-0360. The EPA's policy is that all comments received will be included in the public docket without change and will be made available online at http://www.regulations.gov, including any personal information provided, unless the comment includes information claimed to be CBI or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through http://www.regulations.gov or email. Send or deliver information identified as CBI only to the following address: OAQPS Document Control Officer (C404-02), Office of Air Quality Planning and Standards, U.S. EPA, Research Triangle Park, North Carolina 27711, Attention Docket ID No. EPA-HQ-OAR-2012-0360. Clearly mark the part or all of the information that you claim to be CBI. For CBI information on a disk or CD-ROM that you mail to the EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information you claim as CBI. In addition to one complete version of the comment that includes information claimed as CBI, you must submit a copy of the comment that does not contain the information claimed as CBI for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in the Code of Federal Regulations (CFR) at 40 CFR part 2.

    The http://www.regulations.gov Web site is an “anonymous access” system, which means the EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an email comment directly to the EPA without going through http://www.regulations.gov, your email address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, the EPA recommends that you include your name and other contact information in the body of your comment and with any electronic storage media you submit. If the EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, the EPA may not be able to consider your comment. Electronic files should avoid the use of special characters or any form of encryption and be free of any defects or viruses. For additional information about the EPA's public docket, visit the EPA Docket Center homepage at http://www.epa.gov/dockets.

    Preamble Acronyms and Abbreviations. Multiple acronyms and terms are used in this preamble. While this list may not be exhaustive, to ease the reading of this preamble and for reference purposes, the EPA defines the following terms and acronyms here:

    ACC American Chemistry Council CAA Clean Air Act CBI Confidential Business Information CFR Code of Federal Regulations DOT Department of Transportation EPA Environmental Protection Agency ETC Environmental Technology Council FR Federal Register HAP Hazardous air pollutants MACT Maximum achievable control technology NESHAP National emissions standards for hazardous air pollutants OAQPS Office of Air Quality Planning and Standards OMB Office of Management and Budget OSWRO Off-site waste and recovery operations PRD Pressure relief device RCRA Resource Conservation and Recovery Act RTR Residual risk and technology review TSDF Treatment, storage and disposal facilities

    Organization of this Document. The information in this preamble is organized as follows:

    I. General Information A. What is the source of authority for the reconsideration action? B. Does this action apply to me? C. Where can I get a copy of this document and other related information? II. Background III. Proposed Revisions to PRD Requirements IV. Summary of Cost, Environmental, and Economic Impacts A. What are the affected sources? B. What are the air quality impacts? C. What are the cost impacts? D. What are the economic impacts? E. What are the benefits? V. Statutory and Executive Order Reviews A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review B. Paperwork Reduction Act (PRA) C. Regulatory Flexibility Act (RFA) D. Unfunded Mandates Reform Act (UMRA) E. Executive Order 13132: Federalism F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments G. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks H. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use I. National Technology Transfer and Advancement Act (NTTAA) J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations I. General Information A. What is the source of authority for the reconsideration action?

    The statutory authority for this action is provided by sections 112 and 307(d)(7)(B) of the Clean Air Act (CAA) (42 U.S.C. 7412 and 7607(d)(7)(B)).

    B. Does this action apply to me?

    Categories and entities potentially regulated by this action include, but are not limited to, businesses or government agencies that operate any of the following: Hazardous waste treatment, treatment storage and disposal facilities (TSDF); Resource Conservation and Recovery Act (RCRA) exempt hazardous wastewater treatment facilities; nonhazardous wastewater treatment facilities other than publicly-owned treatment works; used solvent recovery plants; RCRA exempt hazardous waste recycling operations; and used oil re-refineries.

    To determine whether your facility is affected, you should examine the applicability criteria in 40 CFR 63.680 of subpart DD. If you have any questions regarding the applicability of any aspect of these NESHAP, please contact the appropriate person listed in the preceding FOR FURTHER INFORMATION CONTACT section of this preamble.

    C. Where can I get a copy of this document and other related information?

    In addition to being available in the docket, an electronic copy of this action is available on the Internet. A redline version of the regulatory language that incorporates the proposed changes in this action is available in the docket for this action (Docket ID No. EPA-HQ-OAR-2012-0360). Following signature by the EPA Administrator, the EPA will post a copy of this proposed action at https://www.epa.gov/stationary-sources-air-pollution/site-waste-and-recovery-operations-oswro-national-emission. Following publication in the Federal Register, the EPA will post the Federal Register version of the proposed action at this same Web site. Other key technical documents related to this proposal will be available in the docket when the Federal Register version of the proposal is posted to the docket. Only the version as published in the Federal Register will represent the official EPA proposal.

    II. Background

    On March 18, 2015, the EPA promulgated a final rule amending the OSWRO NESHAP based on the RTR conducted for the OSWRO source category (80 FR 14248). In that final rule, the EPA amended the OSWRO NESHAP to revise provisions related to emissions during periods of startup, shutdown, and malfunction; to add requirements for electronic reporting of performance testing; to add monitoring requirements for PRDs; to revise routine maintenance provisions; to clarify provisions for open-ended valves and lines and for some performance test methods and procedures; and to make several minor clarifications and corrections. After publication of the final rule, the EPA received a petition for reconsideration submitted jointly by Eastman Chemical Company and the American Chemical Council (ACC) (dated May 18, 2015). This petition sought reconsideration of two of the amended provisions of the OSWRO NESHAP: (1) The equipment leak provisions for connectors, and (2) the requirement to monitor PRDs on containers. The EPA considered the petition and supporting information along with information contained in the OSWRO NESHAP amendment rulemaking docket (Docket ID No. EPA-HQ-OAR-2012-0360) in reaching a decision on the petition. The Agency granted reconsideration of the PRD monitoring requirement in letters to the petitioners dated February 8, 2016. In separate letters to the petitioners dated May 5, 2016, the Administrator denied reconsideration of the equipment leak provisions for connectors and explained the reasons for the denial in these letters. These letters are available in the OSWRO NESHAP amendment rulemaking docket. The EPA also published a Federal Register notice on May 16, 2016 (81 FR 30182), informing the public of these responses to the petition. On May 18, 2015, ACC filed a petition for judicial review of the OSWRO NESHAP RTR 1 challenging numerous provisions in the final rule, including the issues identified in the petition for administrative reconsideration. In 2016, the EPA and ACC reached an agreement to resolve that case. Specifically, the parties agreed to a settlement under which ACC agrees to dismiss its petition for review of the 2015 final rule if the EPA completes its reconsideration of certain PRD provisions in accordance with an agreed-upon schedule.2

    1 United States Court of Appeals for the District of Columbia Circuit, Case Number 15-1146. Eastman Chemical Company also filed a petition for judicial review of the OSWRO NESHAP RTR, but sought and was granted voluntary dismissal in September 2016.

    2 In accordance with section 113(g) of the CAA (42 U.S.C. 7413(g)), the EPA provided notice and the opportunity for comment on the settlement by publishing a notice in the Federal Register on December 19, 2016 (81 FR 91931). The settlement agreement was finalized on June 15, 2017.

    As a result of our reconsideration, the Agency is proposing revised monitoring requirements for PRDs on containers. The EPA is requesting public comments on these proposed revisions.

    III. Proposed Revisions to PRD Requirements

    In October 2016, two industry trade groups, ACC and the Environmental Technology Council (ETC), gathered and provided the EPA with data related to stationary process PRDs and PRDs on containers for 19 facilities owned by eight companies. The provided data cover calendar years 2013-2015 and include general PRD information, such as the number of PRDs at the facility, the PRDs' set pressure, and the type of equipment the PRDs are on (i.e., stationary equipment or containers). For containers, additional information was provided, including the type and size of the container and the average length of time the containers are onsite before they are emptied. The data also include PRD release information, such as the number of release events that occurred from 2013-2015 and the quantity of emissions from each release event. The companies also identified methods employed to monitor PRD releases, to prevent and control PRD releases, and the perceived effectiveness of these methods. Other data were also provided about the costs to control PRD releases, the impact of force majeure events on PRD releases, types of root cause analyses conducted after a PRD release occurs, PRD inspection frequency, and existing regulations that currently apply to PRDs at OSWRO facilities. The data provided to the EPA by ACC and ETC are available in the docket for this action.

    The March 18, 2015, final amendments to the OSWRO NESHAP include requirements for facilities to monitor PRDs, and since the rule does not distinguish between PRDs on stationary process equipment and those on containers, the monitoring requirements apply to all PRDs. The rule requires a monitoring system capable of: (1) Identifying a pressure release, (2) recording the time and duration of each pressure release, and (3) immediately notifying operators that a pressure release is occurring. Containers used in OSWRO operations include small containers, such as pressurized cylinders and 55-gallon drums, and large containers, such as railcars and over-the-road tanker vehicles. The petition for reconsideration identified concerns regarding the monitoring requirements as they pertain to PRDs on containers and stated that, because containers are frequently moved around the facility and are received from many different off-site locations, it would be difficult, if not impossible, to design and implement a monitoring system for containers that would meet the 2015 rule requirements.

    In reevaluating the PRD monitoring requirements in the 2015 rule as they pertain to containers, we considered what other requirements pertain to these containers and the PRDs on them and the data submitted by ACC and ETC. First, we reviewed the OSWRO NESHAP requirements for containers at 40 CFR 63.688. Depending on the size of the container, the vapor pressure of the container contents, and how the container is used (i.e., for temporary storage and/or transport of the material versus waste stabilization), the rule requires the OSWRO owners and operators to follow the requirements for either Container Level 1, 2, or 3 control requirements as specified in the Container NESHAP at 40 CFR part 63, subpart PP. Each control level specifies requirements to ensure the integrity of the container and its ability to contain its contents (e.g., requirements to meet U.S. Department of Transportation (DOT) regulations on packaging hazardous materials for transportation, or vapor tightness as determined by EPA Method 21, or no detectable leaks as determined by EPA Method 27); requirements for covers and closure devices (which include pressure relief valves as that term is defined in the Container NESHAP at 40 CFR 63.921); and inspection and monitoring requirements for containers and their covers and closure devices pursuant to the Container NESHAP at 40 CFR 63.926. The inspection and monitoring requirements for containers at 40 CFR 63.926, which are already incorporated into the OSWRO NESHAP by 40 CFR 63.688, require that unless the container is emptied within 24 hours of its receipt at the OSWRO facility, the OSWRO owner/operator is required on or before they sign the shipping manifest accepting a container to visually inspect the container and its cover and closure devices (which include PRDs). If a defect of the container, cover, or closure device is identified, the Container NESHAP specify the time period within which the container must be either emptied or repaired. The Container NESHAP require subsequent annual inspection of the container, its cover, and closure devices in the case where a container remains at the facility and has been unopened for a period of 1 year or more. Therefore, the PRD continuous monitoring requirements in the 2015 OSWRO NESHAP at 40 CFR 63.691(c)(3)(i) are in addition to PRD monitoring requirements (as closure devices) already in the OSWRO NESHAP per the Container requirements at 40 CFR 63.688, which incorporate the inspection and monitoring requirements of the subpart PP Container NESHAP. In addition, nearly all OSWRO containers are subject to DOT regulatory requirements to ensure their safe design, construction, and operation while in transport. The DOT regulations at 49 CFR part 178, Specifications for Packagings or 49 CFR part 179, Specifications for Tank Cars, prescribe specific design, manufacturing, and testing requirements for containers that will be transported by motor vehicles. In addition, 49 CFR part 180, Continuing Qualification and Maintenance of Packagings, requires periodic inspections, testing, and repair of containers, which would minimize the chance of an atmospheric release from a PRD.

    Second, we reviewed the dataset provided by ACC and ETC for PRDs on containers includes information for 19 facilities. The types of containers identified in this dataset include pressurized cylinders, drums, tote-tanks, cargo tanks, isotainers, railcars, and tank vehicles, and the containers with PRDs onsite at any one time can be zero or several hundred. The data from ACC and ETC show that containers with PRDs can range in size from a few hundred gallons to up to 25,000 gallons for rail cars, with set pressures (i.e., the pressure at which the PRD is designed to open to relieve excess pressure in the container) varying between 2.5 and 100 pounds per square inch. For OSWRO, the information the EPA reviewed shows that containers remain onsite until the contents can be unloaded, which can vary depending on the operational activities at the facility, and based on the data provided by ACC and ETC, is generally less than 2 weeks. In addition, the data reviewed by the EPA indicate that OSWRO containers are constantly changing (i.e., moving in and out of inventory), and they are frequently moved around the site, depending on storage area capacity and the queue for offloading. Due to the transitory nature of these containers, it would be difficult to design and implement a system to monitor each individual container PRD. These facilities had an annual average of 229 containers with PRDs at the facility site for some period of time during the year. The 3 years of data we received show that there was only one PRD on a container that had an emissions release event. The relief event that occurred was while nitrogen pressure was being applied to a tank truck to off-load waste material. The leak resulted in approximately 40 pounds of volatile organic compounds, of which about 0.4 pounds was an OSWRO NESHAP Table 1, hazardous air pollutant (HAP), over a duration of about 8.5 hours.

    Besides this one PRD release event, no other facilities reported a PRD release in the data provided to the EPA. The one reported release was due to pressure being applied to the tank during material off-loading. No facility reported releases that occurred during storage or transport of the container within the facility. All of these facilities are subject to the subpart PP Container NESHAP inspection requirements, as described above, and did not report detecting any PRD releases or defective conditions during these inspections. An open or defective PRD would be detected by the subpart PP inspection requirements. The EPA's understanding, based substantially on its review of the data provided by ACC and ETC, is that PRD releases from containers are rare, the emissions potential from PRDs on these containers is low, and the additional monitoring requirements for PRDs on the containers that would be required under the 2015 OSWRO NESHAP would be difficult. In addition, the costs for the continuous monitoring requirements in the 2015 rule for PRDs on containers would be very high relative to the low emissions potential. See section IV.C of this preamble for a discussion on the projected costs for a facility to comply with the PRD continuous monitoring requirements on containers in the 2015 OSWRO NESHAP.

    Based on the above considerations, we have determined that the PRD inspection and monitoring requirements in the Container NESHAP that are already incorporated into the container requirements of the OSWRO NESHAP are effective and sufficient given the high cost and difficulty of conducting continuous monitoring as contemplated by 40 CFR 63.691(c)(3)(i) and the low emissions potential from containers at OSWRO facilities. Therefore, we are proposing that PRDs on OSWRO containers will not be subject to the monitoring requirements at 40 CFR 63.691(c)(3)(i), and we are soliciting comment on our assessment and proposal regarding these PRD monitoring requirements.

    The EPA is also soliciting comment on whether to impose more frequent inspections for any filled or partially-filled OSWRO container that remains onsite longer than 60 days. Although the data reviewed show that typically most containers are onsite for less than 2 weeks, there may be instances when, due to facility operations, containers remain onsite and filled or partially-filled for a longer period of time. The EPA is soliciting comment on whether a container that remains onsite for a longer period of time should be required to be visually inspected at a set time, and on an established timeframe thereafter, as long as it remains filled, or partially-filled and onsite. Additionally, the EPA is accepting comment on whether any additional inspection requirements should apply to all containers or only apply to larger containers. Finally, the EPA is also accepting comment on whether to also incorporate the RCRA subpart BB (Air Emission Standards for Equipment Leaks) and subpart CC (Air Emission Standards for Tanks, Surface Impoundments, and Containers) of 40 CFR part 264 and 265 inspection requirements for RCRA permitted and interim status facilities, as these weekly inspections could help facilities identify leaking and or deteriorating containers or cover and closure devices and could help identify any PRD leaks. If the EPA incorporates additional inspection or monitoring requirements as outlined above, we are also soliciting comment on whether to require associated recordkeeping and reporting obligations.

    We are not proposing any other amendments to the OSWRO NESHAP as it pertains to PRDs on containers. Specifically, we are not proposing to alter the requirement that PRDs on containers not release HAP emissions directly to the atmosphere. If a PRD release occurs as a result of a defect of the container, cover, or closure device (which includes PRDs), the owner or operator would be subject to the requirements in the Container NESHAP at 40 CFR 63.926(a)(3), as referenced from the OSWRO NESHAP at 63.688, that require emptying of the container or repair within a specified time period. Further, if a PRD fails to re-seat itself, this would also likely be considered a defect in the PRD and, therefore, would be subject to the same requirements in the Container NESHAP at 63.926(a)(3).

    We are also not proposing any changes to the requirements for owners and operators to quantify the amount of Table 1 HAP emissions associated with a release from a PRD as those requirements at 40 CFR 63.691(c)(3)(ii) apply to PRDs on containers or to the requirements to report such releases at 63.697(b)(5). We are not proposing changes to these requirements since they allow calculations based on process knowledge, and do not require that calculations be based on monitoring conducted pursuant at 63.691(c)(3)(i).

    IV. Summary of Cost, Environmental, and Economic Impacts A. What are the affected sources?

    We estimate that 49 existing sources would be affected by the revised monitoring requirements being proposed in this action.

    B. What are the air quality impacts?

    We are proposing revised requirements for PRD monitoring on containers on the basis that the inspection and monitoring requirements in 40 CFR part 63, subpart PP incorporated into the OSWRO NESHAP are sufficient. We project that the proposed standard would not result in any change in emissions compared to the existing OSWRO NESHAP.

    C. What are the cost impacts?

    When the OSWRO NESHAP were finalized in 2015, the EPA was not aware of equipment meeting the definition of a PRD on containers in the OSWRO industry, and costs associated with the PRD release event prohibition and monitoring requirements were not estimated for this equipment. Therefore, the capital and annualized costs in the 2015 final rule were underestimated, as these costs were not included. To determine the impacts of the 2015 final rule, considering the monitoring requirements for PRDs on containers based on the data now available to the EPA from ACC and ETC, we have estimated the costs and the potential emission reductions associated with wireless PRD monitors for containers. Using vendor estimates for wireless PRD monitor costs, we estimate that the capital costs per facility with the average number of containers with PRDs would be approximately $570,000, and the capital costs for the industry (49 facilities) would be approximately $28 million. The total annualized costs per facility (assuming a 15-year equipment life and a 7- percent interest rate) are estimated to be approximately $85,000 and approximately $4.2 million for the industry. Therefore, by removing the requirement to monitor PRDs on containers, we estimate the impact of our proposal to be an annual reduction of $4.2 million. Cost information, including wireless PRD monitor costs, is available in the docket for this action.

    D. What are the economic impacts?

    We performed a national economic impact analysis for the 49 OSWRO facilities affected by this proposed rule. The updated national costs under this reconsideration, accounting for the data provided by ACC and the ETC, are $1.3 million in capital costs in 2018, or $200,000 in total annualized costs under a 7-percent interest rate ($170,000 million in total annualized costs under a 3-percent interest rate).3 After updating the baseline costs of the PRD monitoring requirements as written in the 2015 rule, in consideration of the data provided by ACC and the ETC, this reconsideration constitutes a $28 million reduction in the capital cost or a $4.2 million reduction in annualized costs assuming an interest rate of 7-percent ($3.4 million reduction in annualized costs assuming an interest rate of 3-percent). These costs can be seen in Table 1.

    3 We assume affected facilities will start incurring costs in 2018, after the final rule is finalized.

    Table 1—Re-Estimated Cost and Reconsideration Cost [$2016, millions] Capital costs Total annualized costs 7% 3% Re-estimated Cost (New Baseline) 29 4.4 3.6 Reconsidered Cost 1.3 0.20 0.17 Burden Reduction 28 4.2 3.4 Note: Estimates rounded to 2 significant figures. Totals may not sum due to rounding.

    In terms of the present value of the costs, the reconsidered requirements compared to the re-estimated costs of the promulgated rule (the new baseline) constitute a decrease of $39 million under a 7-percent discount rate ($42 million under a 3-percent discount rate). In terms of the equivalent annualized values, this reconsideration constitutes $4.3 million dollars annually at a 7-percent discount rate ($3.5 million annually at a 3-percent discount rate) in reduced compliance costs compared to the new baseline estimation.4 These values can be seen in Table 2, below.

    4 The equivalent annualized value represents the even flow of the present value of costs over the technical life of the monitors.

    Table 2—Re-Estimated PRD Promulgated Cost and Reconsideration Cost [$2016, millions] Re-estimated cost
  • (new baseline)
  • 7% 3% Reconsidered cost 7% 3% Burden reduction 7% 3%
    Present Value $41 $44 $1.9 $2.0 −$39 −$42 Equivalent Annualized Value 4.5 3.7 0.20 0.17 −4.3 −3.5 Note: These values are estimated over 15 years. Totals may not sum due to rounding.

    More information and details of this analysis, including the conclusions stated above, are provided in the technical document, “Economic Impact Analysis for the Proposed Reconsideration of the 2015 NESHAP: Off-Site Waste and Recovery Operations,” which is available in the rulemaking docket.

    E. What are the benefits?

    We project that the proposed standard would not result in any change in emissions compared to the existing OSWRO NESHAP.

    V. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive Orders can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.

    A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review

    This action is not a significant regulatory action and was, therefore, not submitted to the Office of Management and Budget (OMB) for review.

    B. Paperwork Reduction Act (PRA)

    This action does not impose any new information collection burden under the PRA. OMB has previously approved the information collection activities contained in the existing regulations at 40 CFR part 63, subpart DD under the provisions of the PRA, 44 U.S.C. 3501 et seq. and has assigned OMB control number 1717.11. The proposed amendments removed monitoring requirements for PRDs on containers, and these proposed amendments do not affect the estimated information collection burden of the existing rule. You can find a copy of the Information Collection Request in the docket at Docket ID No. EPA-HQ-OAR-2012-0360 for this rule.

    C. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. In making this determination, the impact of concern is any significant adverse economic impact on small entities. An agency may certify that a rule will not have a significant economic impact on a substantial number of small entities if the rule relieves regulatory burden, has no net burden, or otherwise has a positive economic effect on the small entities subject to the rule. This rule relieves regulatory burden by reducing compliance costs associated with monitoring PRDs on containers. The Agency has determined that of the 28 firms that own the 49 facilities in the OSWRO source category, two firms, or 7 percent, can be classified as small firms. The cost to sales ratio of the reconsidered cost of the monitoring requirements for these two firms is significantly less than 1 percent. In addition, this action constitutes a burden reduction compared to the re-estimated costs of the 2015 rule as promulgated. We have, therefore, concluded that this action does not have a significant impact on a substantial number of small entities. For more information, see the “Economic Impact Analysis for the Proposed Reconsideration of the 2015 NESHAP: Off-Site Waste and Recovery Operations,” which is available in the rulemaking docket.

    D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain an unfunded mandate of $100 million or more as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The action imposes no enforceable duty on any state, local, tribal governments, or the private sector.

    E. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.

    F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments

    This action does not have tribal implications as specified in Executive Order 13175. This action will not have substantial direct effects on tribal governments, on the relationship between the federal government and Indian tribes, or on the distribution of power and responsibilities between the federal government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this action.

    G. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks

    This action is not subject to Executive Order 13045 because it is not economically significant as defined in Executive Order 12866, and because the EPA does not believe the environmental health or safety risks addressed by this action present a disproportionate risk to children. The EPA's risk assessments for the 2015 final rule (Docket ID No. EPA-HQ-OAR-2012-0360) demonstrate that the current regulations are associated with an acceptable level of risk and provide an ample margin of safety to protect public health and prevent adverse environmental effects. This proposed action would not alter those conclusions.

    H. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use

    This action is not subject to Executive Order 13211 because it is not a significant regulatory action under Executive Order 12866.

    I. National Technology Transfer and Advancement Act (NTTAA)

    This rulemaking does not involve technical standards.

    J. Executive Order 12898: Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations

    The EPA believes that this action does not have disproportionately high and adverse human health or environmental effects on minority populations, low-income populations, and/or indigenous peoples, as specified in Executive Order 12898 (59 FR 7629, February 16, 1994).

    In the 2015 final rule, the EPA determined that the current health risks posed by emissions from this source category are acceptable and provide an ample margin of safety to protect public health and prevent adverse environmental effects. To gain a better understanding of the source category and near source populations, the EPA conducted a proximity analysis for OSWRO facilities prior to proposal in 2014 to identify any overrepresentation of minority, low income, or indigenous populations. This analysis gave an indication of the prevalence of sub-populations that might be exposed to air pollution from the sources. We revised this analysis to include four additional OSWRO facilities that the EPA learned about after proposal for the 2015 rule. The EPA determined that the final rule would not have disproportionately high and adverse human health or environmental effects on minority, low income, or indigenous populations. The revised proximity analysis results and the details concerning its development are presented in the memorandum titled, Updated Environmental Justice Review: Off-Site Waste and Recovery Operations RTR, available in the docket for this action (Docket Document ID No. EPA-HQ-OAR-2012-0360-0109). This proposed action would not alter the conclusions made in the 2015 final rule regarding this analysis.

    List of Subjects in 40 CFR Part 63

    Environmental protection, Administrative practice and procedure, Air pollution control, Hazardous substances, Intergovernmental relations, Reporting and recordkeeping requirements.

    Dated: July 27, 2017. E. Scott Pruitt, Administrator.

    For the reasons set forth in the preamble, title 40, chapter I of the Code of Federal Regulations is proposed to be amended as follows:

    PART 63—NATIONAL EMISSION STANDARDS FOR HAZARDOUS AIR POLLUTANTS FOR SOURCE CATEGORIES 1. The authority citation for part 63 continues to read as follows: Authority:

    42 U.S.C. 7401, et seq.

    Subpart DD—National Emission Standards for Hazardous Air Pollutants for Hazardous Air Pollutants from Off-Site Waste and Recovery Operations 2. Section 63.691 is amended by revising paragraph (c)(3) introductory text to read as follows:
    § 63.691 Standards: Equipment leaks.

    (c) * * *

    (3) Pressure release management. Except as provided in paragraph (c)(4) of this section, emissions of HAP listed in Table 1 of this subpart may not be discharged directly to the atmosphere from pressure relief devices in off-site material service, and according to the date an affected source commenced construction or reconstruction and the date an affected source receives off-site material for the first time, as established in § 63.680(e)(i) through (iii), the owner or operator must comply with the requirements specified in paragraphs (c)(3)(i) and (ii) of this section for all pressure relief devices in off-site material service, except that containers are not subject to the obligations in (c)(3)(i) of this section.

    [FR Doc. 2017-16494 Filed 8-4-17; 8:45 a.m.] BILLING CODE 6560-50-P
    DEPARTMENT OF TRANSPORTATION Federal Motor Carrier Safety Administration 49 CFR Part 389 [Docket No. FMCSA-2016-0341] RIN 2126-AB96 Rulemaking Procedures Update AGENCY:

    Federal Motor Carrier Safety Administration (FMCSA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    FMCSA proposes to amend its rulemaking procedures by revising the process for preparing and adopting rules, petitions, and direct final rules. Also, the Agency adds new definitions, and makes general administrative corrections throughout its rulemaking procedures. These proposed actions are authorized under the Fixing America's Surface Transportation (FAST) Act and the Administrative Procedure Act (APA).

    DATES:

    Comments on this document must be received on or before October 6, 2017.

    ADDRESSES:

    You may submit comments identified by Docket Number FMCSA-2016-0341 using any of the following methods:

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

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

    Hand Delivery or Courier: West Building, Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

    Fax: 202-493-2251.

    To avoid duplication, please use only one of these four methods. See the “Public Participation and Request for Comments” portion of the SUPPLEMENTARY INFORMATION section for instructions on submitting comments.

    FOR FURTHER INFORMATION CONTACT:

    Mr. Bivan R. Patnaik, Chief, Regulatory Development Division, Federal Motor Carrier Safety Administration, 1200 New Jersey Avenue SE., Washington, DC 20590-0001 or by telephone at 202-366-8092 or [email protected] If you have questions on viewing or submitting material to the docket, contact Docket Services, telephone (202) 366-9826.

    SUPPLEMENTARY INFORMATION:

    This NPRM is organized as follows:

    I. Public Participation and Request for Comments A. Submitting Comments B. Viewing Comments and Documents C. Privacy Act D. Waiver of Advance Notice of Proposed Rulemaking II. Legal Basis for the Rulemaking III. Discussion of Proposed Rulemaking IV. International Impacts V. Section-by-Section Analysis VI. Regulatory Analyses A. E.O. 12866 (Regulatory Planning and Review and DOT Regulatory Policies and Procedures as Supplemented by E.O. 13563) B. Regulatory Flexibility Act (Small Entities) C. Assistance for Small Entities D. Unfunded Mandates Reform Act of 1995 E. Paperwork Reduction Act (Collection of Information) F. E.O. 13132 (Federalism) G. E.O. 12988 (Civil Justice Reform) H. E.O. 13045 (Protection of Children) I. E.O. 12630 (Taking of Private Property) J. Privacy K. E.O. 12372 (Intergovermental Review) L. E.O. 13211 (Energy Supply, Distribution, or Use) M. E.O. 13175 (Indian Tribal Governments) N. National Technology Transfer and Advancement Act (Technical Standards) O. Environment (NEPA, CAA, Environmental Justice) I. Public Participation and Request for Comments A. Submitting Comments

    If you submit a comment, please include the docket number for this NPRM (Docket No. FMCSA-2016-0341), indicate the specific section of this document to which each section of your comment applies, and provide a reason for each suggestion or recommendation. You may submit your comments and material online or by fax, mail, or hand delivery, but please use only one of these means. FMCSA recommends that you include your name and a mailing address, an email address, or a phone number in the body of your document so that FMCSA can contact you if there are questions regarding your submission.

    To submit your comment online, go to http://www.regulations.gov, put the docket number, FMCSA-2016-0341, in the keyword box, and click “Search.” When the new screen appears, click on the “Comment Now!” button and type your comment into the text box on the following screen. Choose whether you are submitting your comment as an individual or on behalf of a third party and then submit.

    If you submit your comments by mail or hand delivery, submit them in an unbound format, no larger than 81/2 by 11 inches, suitable for copying and electronic filing. If you submit comments by mail and would like to know that they reached the facility, please enclose a stamped, self-addressed postcard or envelope.

    FMCSA will consider all comments and material received during the comment period and may change this proposed rule based on your comments. FMCSA may issue a final rule at any time after the close of the comment period.

    B. Viewing Comments and Documents

    To view comments, as well as any documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov. Insert the docket number, FMCSA-2016-0341, in the keyword box, and click “Search.” Next, click the “Open Docket Folder” button and choose the document to review. If you do not have access to the Internet, you may view the docket online by visiting the Docket Management Facility in Room W12-140 on the ground floor of the DOT West Building, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

    C. Privacy Act

    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 www.regulations.gov, as described in the system of records notice (DOT/ALL-14 FDMS), which can be reviewed at www.dot.gov/privacy.

    D. Waiver of Advance Notice of Proposed Rulemaking

    Under section 5202 of the FAST Act (Pub. L. 114-94, 129 Stat. 1312, 1534, December 4, 2015; 49 U.S.C. 31136(g)), if a proposed rule regarding commercial motor vehicle safety is likely to lead to the promulgation of a major rule, FMCSA is required to publish an advance notice of proposed rulemaking (ANPRM), or proceed with a negotiated rulemaking, unless the Agency finds good cause that both would be impracticable, unnecessary, or contrary to the public interest. As today's NPRM is not proposing any requirements regarding commercial motor vehicle safety and would not lead to promulgation of a major rule, FMCSA finds that publication of an ANPRM or proceeding with a negotiated rulemaking are unnecessary and contrary to the public interest in this case.

    II. Legal Basis for the Rulemaking

    The FAST Act requires FMCSA to address its rulemaking and petitions procedures. Specifically, section 5202 provides requirements for the Agency to follow regarding the development of proposed rulemakings [49 U.S.C. 31136(f)-(h)]. Section 5204 also directs the Agency to be more transparent to the public regarding how FMCSA prioritizes and defines petitions.

    The APA (5 U.S.C. 551-706) established procedures for all Federal agencies to use in developing rules and regulations. It also established the standards that allow the public to participate in a rulemaking as well as the opportunity to petition the Federal government for the issuance, amendment, or repeal or a rule. The APA authorizes those proposed changes to Part 389, beyond what is required by the FAST Act.

    III. Discussion of Proposed Rulemaking

    FMCSA proposes several changes to the regulatory procedural requirements found in 49 CFR part 389. These changes fall into the three general categories outlined below, and are explained in further detail in the section-by-section analysis.

    A. Advance Rulemaking Procedures Required

    FMCSA proposes new rulemaking provisions required by the FAST Act where the Agency must consider undertaking a negotiated rulemaking or an ANPRM for all major rules regarding commercial motor vehicle safety. However, the FAST Act allows the Administrator to waive this requirement in instances where those tools would be impracticable, unnecessary, or contrary to the public interest. Additionally, the NPRM proposes a definition of a “major rule” as defined in the Congressional Review Act (5 U.S.C. 801). FMCSA would use this definition to determine whether an ANPRM or negotiated rulemaking process is necessary.

    B. Definition and Processing of a Petition

    Under the current FMSA regulations (49 CFR part 389) for submitting petitions, there is no regulatory definition of a petition. However, section 5204 of the FAST Act clearly defines the term “petition.” It includes requests for: A new regulation; a regulatory interpretation or clarification; or a determination by FMCSA that a regulation should be modified or eliminated for one of several enumerated reasons prescribed in section 5204. FMCSA proposes to include this definition in part 389.

    Additionally, under this proposal, part 389 would be revised to include a new process for filing and addressing petitions. These changes are being proposed in order to clarify FMCSA's procedures for rulemaking, and to make editorial changes.

    Finally, FMCSA proposes to define what “written or in writing” means to include electronic documentation.

    C. Direct Final Rulemaking Procedures

    Under FMCSA's current direct final rulemaking (DFR) procedures, if the Agency receives a notice of intent (NOI) to file an adverse comment, the DFR will be withdrawn, even if the comment that is eventually filed does not meet the definition of an adverse comment found in 49 CFR 389.39(b). FMCSA proposes to change this requirement. Upon receiving an NOI to file an adverse comment, the Agency would extend the comment period rather than withdraw the DFR, allowing the commenter additional time to file. Once FMCSA receives the comment, the Agency would determine whether it is adverse. If it is an adverse comment, FMCSA would withdraw the DFR; however, if it does not meet the definition in § 389.39(b), the Agency would move forward with the DFR. If the same or another commenter submits an NOI at the end of the extended comment period, FMCSA will determine, on a case-by-case basis, whether to extend the comment period again, withdraw the DFR, or proceed with the DFR using only the comments already received.

    IV. International Impacts

    The FMCSRs, and any exceptions to the FMCSRs, apply only within the United States (and, in some cases, United States territories). Motor carriers and drivers are subject to the laws and regulations of the countries that they operate in, unless an international agreement states otherwise. Drivers and carriers should be aware of the regulatory differences amongst nations.

    V. Section-by-Section Analysis

    Throughout part 389, FMCSA would change the term “rule making” to “rulemaking” for consistency.

    Section 389.3 Definitions

    FMCSA would add new definitions of “major rule,” “petitions,” and “written or in writing” to § 389.3.

    Section 389.13 Initiation of Rulemaking

    In § 389.13, FMCSA would redesignate the existing text into paragraph (a) and would add paragraphs (b)(1) through (b)(3).

    Proposed paragraph (b) of section 389.13 and its subparagraphs include the advanced public participation requirements from section 5202 of the FAST Act.

    Section 389.15 Contents of Notices of Proposed Rulemaking

    The title of § 389.15 is changed by removing the space between “rule” and “making.”

    Section 389.21 Submission of Written Comments

    FMCSA proposes revising § 389.21 to include direction on how comments should be submitted. The Agency would remove the text regarding incorporation by reference, as it is not relevant to the topic of comment submission. FMCSA also proposes renaming the section heading to “Submission of written comments” to reflect this change.

    Section 389.29 Adoption of Final Rules

    In § 389.29, FMCSA makes minor changes to the text to clarify the procedure followed when the Agency finalizes a rule.

    Section 389.31 Petitions for Rulemaking

    In § 389.31(a) the word “repeal” would be replaced with “withdraw” to more accurately describe the removal of a regulation. In paragraph (b)(1) the word “duplicate” would be replaced with “writing” to make use of and follow the definition of this term, proposed in § 389.3. This proposed change would also reflect that the Agency no longer requires duplicate submissions.

    Section 389.39 Direct Final Rulemaking Procedures

    In § 389.39, FMCSA would remove language regarding the withdrawal of a DFR if the Agency receives an NOI to submit an adverse comment. Upon receipt of an NOI, the Agency would extend the comment period to give the submitter additional time to file the comment. Once submitted, the comment would be reviewed to determine if it is an adverse comment, and proceed according to the results of that analysis (either to withdraw the DFR if the comment is adverse, or to move forward with the DFR if it is not).

    VI. Regulatory Analyses A. E.O. 12866 (Regulatory Planning and Review and DOT Regulatory Policies and Procedures as Supplemented by E.O. 13563)

    This NPRM is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, as supplemented by E.O. 13563 (76 FR 3821, January 21, 2011), and is also not significant within the meaning of DOT regulatory policies and procedures (DOT Order 2100.5 dated May 22, 1980; 44 FR 11034, February 26, 1979) and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order.

    This rule is procedural in nature, primarily impacting FMCSA's process for promulgation of regulations. As a result, there would be no costs associated with this NPRM.

    B. Regulatory Flexibility Act (Small Entities)

    The Regulatory Flexibility Act of 1980 (5 U.S.C. 601 et seq.) requires Federal agencies to consider the effects of the regulatory action on small business and other small entities and to minimize any significant economic impact. The term “small entities” comprises small businesses and not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.1 Accordingly, DOT policy requires an analysis of the impact of all regulations on small entities, and mandates that agencies strive to lessen any adverse effects on these businesses.

    1 Regulatory Flexibility Act (5 U.S.C. 601 et seq.) see National Archives at http://www.archives.gov/federal-register/laws/regulaotry-flexibility/601.html.

    FMCSA does not expect this NPRM to have a significant economic impact on a substantial number of small entities. Consequently, I certify that the action would not have a significant economic impact on a substantial number of small entities. FMCSA invites comment from members of the public who believe there will be a significant impact either on small businesses or on governmental jurisdictions with a population of less than 50,000.

    C. Assistance for Small Entities

    In accordance with section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996, FMCSA wants to assist small entities in understanding this NPRM so that they can better evaluate its effects on themselves and participate in the rulemaking initiative. If the NPRM will affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance; please consult the FMCSA point of contact, Mr. Bivan Patnaik, listed in the FOR FURTHER INFORMATION CONTACT section of this NPRM.

    Small businesses may send comments on the actions of Federal employees who enforce or otherwise determine compliance with Federal regulations to the Small Business Administration's Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of FMCSA, call 1-888-REG-FAIR (1-888-734-3247). DOT has a policy regarding the rights of small entities to regulatory enforcement fairness and an explicit policy against retaliation for exercising these rights.

    D. Unfunded Mandates Reform Act of 1995

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $156 million (which is the value equivalent of $100,000,000 in 1995, adjusted for inflation to 2015 levels) or more in any one year. As the proposed rule is procedural in nature and is not expected to result in any costs at the societal level, it would likewise not impose costs to State, local, or tribal governments.

    E. Paperwork Reduction Act (Collection of Information)

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

    F. E.O. 13132 (Federalism)

    A rule has implications for Federalism under Section 1(a) of Executive Order 13132 if it has “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” FMCSA has determined that this NPRM would not have substantial direct costs on or for States, nor would it limit the policymaking discretion of States. Nothing in this document preempts any State law or regulation. Therefore, this NPRM does not have sufficient Federalism implications to warrant the preparation of a Federalism Impact Statement.

    G. E.O. 12988 (Civil Justice Reform)

    This NPRM meets applicable standards in sections 3(a) and 3(b) (2) of E.O. 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.

    H. E.O. 13045 (Protection of Children)

    E.O. 13045, Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, Apr. 23, 1997), requires agencies issuing “economically significant” rules, if the regulation also concerns an environmental health or safety risk that an agency has reason to believe may disproportionately affect children, to include an evaluation of the regulation's environmental health and safety effects on children. The Agency determined this NPRM is not economically significant. Therefore, no analysis of the impacts on children is required. In any event, the Agency does not anticipate that this regulatory action would in any respect present an environmental or safety risk that could disproportionately affect children.

    I. E.O. 12630 (Taking of Private Property)

    FMCSA reviewed this NPRM in accordance with E.O. 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights, and has determined it will not effect a taking of private property or otherwise have taking implications.

    J. Privacy

    Section 522 of title I of division H of the Consolidated Appropriations Act, 2005, enacted December 8, 2004 (Pub. L. 108-447, 118 Stat. 2809, 3268, 5 U.S.C. 552a note), requires the Agency to conduct a privacy impact assessment (PIA) of a regulation that will affect the privacy of individuals. This NPRM does not require the collection of personally identifiable information (PII).

    The Privacy Act (5 U.S.C. 552a) applies only to Federal agencies and any non-Federal agency which receives records contained in a system of records from a Federal agency for use in a matching program.

    The E-Government Act of 2002, Public Law 107-347, 208, 116 Stat. 2899, 2921 (Dec. 17, 2002), requires Federal agencies to conduct PIA for new or substantially changed technology that collects, maintains, or disseminates information in an identifiable form.

    No new or substantially changed technology would collect, maintain, or disseminate information as a result of this NPRM. As a result, FMCSA has not conducted a privacy impact assessment.

    K. E.O. 12372 (Intergovernmental Review)

    The regulations implementing E.O. 12372 regarding intergovernmental consultation on Federal programs and activities do not apply to this NPRM.

    L. E.O. 13211 (Energy Supply, Distribution, or Use)

    FMCSA has analyzed this NPRM under E.O. 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. The Agency has determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” likely to have a significant adverse effect on the supply, distribution, or use of energy. Therefore, it does not require a Statement of Energy Effects under E.O. 13211. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.

    M. E.O. 13175 (Indian Tribal Governments)

    This NPRM does not have tribal implications under E.O. 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

    N. National Technology Transfer and Advancement Act (Technical Standards)

    The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through OMB, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards (e.g., specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) are standards that are developed or adopted by voluntary consensus standards bodies. This NPRM does not use technical standards. Therefore, FMCSA did not consider the use of voluntary consensus standards.

    O. Environment (NEPA, CAA, Environmental Justice)

    FMCSA analyzed this rule for the purpose of the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq.) and determined this action is categorically excluded from further analysis and documentation in an environmental assessment or environmental impact statement under FMCSA Order 5610.1 (69 FR 9680, March 1, 2004), Appendix 2, paragraph 6.x. The Categorical Exclusion (CE) in paragraph 6.x. addresses regulations implementing procedures for the issuance, amendment, revision and rescission of Federal motor carrier regulations (e.g., the establishment of procedural rules that would provide general guidance on how the agency manages its notice-and-comment rulemaking proceedings, including the handling of petitions for rulemakings, waivers, exemptions, and reconsiderations, and how it manages delegations of authority to carry out certain rulemaking functions.). The content in this rule is covered by this CE and the proposed action would not have any effect on the quality of the environment. The CE determination is available for inspection or copying in the Federal eRulemaking Portal: http://www.regulations.gov.

    FMCSA also analyzed this rule under the Clean Air Act, as amended (CAA), section 176(c) (42 U.S.C. 7401 et seq.), and implementing regulations promulgated by the Environmental Protection Agency. Approval of this action is exempt from the CAA's general conformity requirement since it does not affect direct or indirect emissions of criteria pollutants.

    Under E.O. 12898, each Federal agency must identify and address, as appropriate, “disproportionately high and adverse human health or environmental effects of its programs, policies, and activities on minority populations and low-income populations” in the United States, its possessions, and territories. FMCSA evaluated the environmental justice effects of this proposed rule in accordance with the E.O., and has determined that no environmental justice issue is associated with this proposed rule, nor is there any collective environmental impact that would result from its promulgation.

    List of Subjects in 49 CFR Part 389

    Administrative practice and procedure, Highway safety, Motor carriers, Motor vehicle safety.

    In consideration of the foregoing, FMCSA proposes to amend 49 CFR chapter III, part 389 to read as follows:

    PART 389—RULEMAKING PROCEDURES—FEDERAL MOTOR CARRIER SAFETY REGULATIONS 1. The authority citation for part 389 is revised to read as follows: Authority:

    Authority: 49 U.S.C. 113, 501 et seq., subchapters I and III of chapter 311, chapter 313, and 31502; sec. 5204 of Pub. L. 114-94, 129 Stat. 1312. 1536, 42 U.S.C. 4917; and 49 CFR 1.87.

    2. Amend § 389.3 by adding definitions of Major rule, Petition, and Written or in writing in alphabetical order to read as follows:
    § 389.3 Definitions.

    Major rule means:

    (1) Any rule that the Administrator of the Office of Information and Regulatory Affairs of the Office of Management and Budget finds has resulted in or is likely to result in:

    (i) An annual effect on the economy of $100,000,000 or more;

    (ii) A major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions; or

    (iii) Significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based enterprises to compete with foreign-based enterprises in domestic and export markets.

    (2) The term does not include any rule promulgated under the Telecommunications Act of 1996 and the amendments made by that Act.

    Petition means a request for:

    (1) A new regulation;

    (2) A regulatory interpretation or clarification; or

    (3) A determination made by the Administrator that a regulation should be modified or eliminated because it is:

    (i) No longer:

    (A) Consistent and clear;

    (B) Current with the operational realities of the motor carrier industry; or

    (C) Uniformly enforced.

    (ii) Ineffective; or

    (iii) Overly burdensome.

    Written or in writing means printed, handwritten, typewritten either on paper or other tangible medium, or by any method of electronic documentation such as electronic mail.

    § 389.7 [Amended]
    3. Amend § 389.7 by removing the term “rule making” and add the term “rulemaking” in its place. 4. Revise § 389.13 to read as follows:
    § 389.13 Initiation of rulemaking

    (a) The Administrator initiates rulemaking on his/her own motion. However, in so doing, he/she may, in his/her discretion, consider the recommendations of his/her staff or other agencies of the United States or of other interested persons.

    (b) If a proposed rule regarding commercial motor vehicle safety is likely to lead to the promulgation of a major rule, the Administrator, before publishing such proposed rule, shall—

    (1) Issue an advance notice of proposed rulemaking that:

    (i) Identifies the need for a potential regulatory action;

    (ii) Identifies and requests public comment on the best available science or technical information relevant to analyzing potential regulatory alternatives;

    (iii) Requests public comment on the available data and costs with respect to regulatory alternatives reasonably likely to be considered as part of the rulemaking; and

    (iv) Requests public comment on available alternatives to regulation; or

    (2) Proceed with a negotiated rulemaking.

    (3) This paragraph does not apply to a proposed rule if the Administrator, for good cause, finds (and incorporates the finding and a brief statement of reasons for such finding in the proposed or final rule) that an advance notice of proposed rulemaking is impracticable, unnecessary, or contrary to the public interest.

    § 389.15 [Amended]
    5. In § 389.15, paragraph (a), remove the term “rule making” and add the term “rulemaking” in its place. 6. Revise § 389.21 to read as follows:
    § 389.21 Submission of written comments.

    (a) You may submit comments identified by the docket number provided in the rulemaking document using any of the following methods. To avoid duplication, please use only one of these four methods.

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

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

    (3) Hand Delivery or Courier: West Building, Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

    (4) Fax: 202-493-2251.

    (b) All written comments must be submitted in English and include copies of any material that the commenter refers to within the comment.

    7. Revise § 389.29 to read as follows:
    § 389.29 Adoption of final rules.

    Final rules are prepared by representatives from all relevant offices of FMCSA. The final rule is then submitted to the Administrator for his/her consideration. If the Administrator adopts the rule, and once approved by the Office of the Management and Budget, if necessary, the final rule is published in the Federal Register, unless all persons subject to the final rule are named and personally served with a copy of it.

    8. Revise § 389.31 to read as follows:
    § 389.31 Petitions for rulemaking.

    (a) Any interested person may petition the Administrator to establish, amend, or withdraw a rule.

    (b) Each petition filed under this section must:

    (1) Be submitted in writing to the Administrator, Federal Motor Carrier Safety Administration, 1200 New Jersey Ave. SE., Washington, DC 20590-0001;

    (2) Set forth the text or substance of the rule or amendment proposed, or specify the rule that the petitioner seeks to have repealed, as the case may be;

    (3) Explain the interest of the petitioner in the action requested;

    (4) Contain any information, data, research studies, and arguments available to the petitioner to support the action sought.

    9. In § 389.39, redesignate paragraphs (c) and (d) as paragraphs (d) and (e), respectively, add new paragraph (c), and revise newly redesignated paragraphs (d) and (e) to read as follows:
    § 389.39 Direct final rulemaking procedures.

    (c) Extension of comment period. FMCSA will extend the comment period for a direct final rule if it receives a notice of intent to submit an adverse comment. Upon receipt of the comment, FMCSA will determine if it is an adverse comment or not.

    (d) Confirmation of effective date. FMCSA will publish a confirmation rule document in the Federal Register, if it has not received an adverse comment by the specified date in the direct final rule or any comment extension document. The confirmation rule document tells the public the effective date of the rule.

    (e) Withdrawal of a direct final rule. (1) If FMCSA receives an adverse comment within the original or extended comment period, it will publish a rule document in the Federal Register before the effective date of the direct final rule advising the public and withdrawing the direct final rule.

    (2) If FMCSA withdraws a direct final rule because of an adverse comment, the Agency may issue a notice of proposed rulemaking if it decides to pursue the rulemaking.

    Issued under authority delegated in 49 CFR 1.87 on: July 31, 2017. Daphne Y. Jefferson, Deputy Administrator.
    [FR Doc. 2017-16452 Filed 8-4-17; 8:45 am] BILLING CODE 4910-EX-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 300 [Docket No. 170712657-7659-01] RIN 0648-BG85 International Fisheries; Pacific Tuna Fisheries; Restrictions on Fishing for Sharks in the Eastern Pacific Ocean AGENCY:

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

    ACTION:

    Proposed rule; request for comments.

    SUMMARY:

    NMFS proposes regulations under the Tuna Conventions Act to implement Resolution C-16-05 (Resolution on the Management of Shark Species) of the Inter-American Tropical Tuna Commission (IATTC) adopted in July 2016. Per the Resolution, this proposed rule would require purse seine vessel owners, operators, and crew to follow specified release requirements for sharks in the eastern Pacific Ocean (EPO). The rule would also prohibit longline vessels targeting tuna or swordfish in the EPO from using “shark lines” (a type of fishing gear used on longline vessels to target sharks). This proposed rule is necessary for the United States to satisfy its obligations as a member of the IATTC.

    DATES:

    Comments on the proposed rule and supporting documents must be submitted in writing by September 6, 2017.

    ADDRESSES:

    You may submit comments on this document, identified by NOAA-NMFS-2017-0068, by any of the following methods:

    Electronic Submission: Submit all electronic public comments via the Federal e-Rulemaking Portal. Go to http://www.regulations.gov/#!docketDetail;D=NOAA-NMFS-2017-0068, click the “Comment Now!” icon, complete the required fields, and enter or attach your comments.

    Mail: Submit written comments to Daniel Studt, NMFS West Coast Region Long Beach Office, 501 W. Ocean Blvd., Suite 4200, Long Beach, CA 90802. Include the identifier “NOAA-NMFS-2017-0068” in the comments.

    Instructions: Comments must be submitted by one of the above methods to ensure they are received, documented, and considered by NMFS. 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. All comments received are a part of the public record and will generally be posted for public viewing on www.regulations.gov without change. All personal identifying information (e.g., name, address, etc.) submitted voluntarily by the sender will be publicly accessible. Do not submit confidential business information, or otherwise sensitive or protected information. NMFS will accept anonymous comments (enter “N/A” in the required fields if you wish to remain anonymous).

    Copies of the draft Regulatory Impact Review and other supporting documents are available via the Federal eRulemaking Portal: http://www.regulations.gov, docket NOAA-NMFS-2017-0068, or by contacting the Regional Administrator, Barry A. Thom, NMFS West Coast Region, 1201 NE Lloyd Boulevard, Suite 1100, Portland, OR 97232-1274, or [email protected]

    FOR FURTHER INFORMATION CONTACT:

    Daniel Studt, NMFS, West Coast Region, 562-980-4073.

    SUPPLEMENTARY INFORMATION:

    Background on the IATTC

    The United States is a member of the IATTC, which was established under the 1949 Convention for the Establishment of an Inter-American Tropical Tuna Commission. In 2003, the IATTC adopted the Convention for the Strengthening of the IATTC Established by the 1949 Convention between the United States of America and the Republic of Costa Rica (Antigua Convention). The Antigua Convention entered into force in 2010. The United States acceded to the Antigua Convention on February 24, 2016. The full text of the Antigua Convention is available at: https://www.iattc.org/PDFFiles2/Antigua_Convention_Jun_2003.pdf.

    The IATTC consists of 21 member nations and four cooperating non-member nations and facilitates scientific research into, as well as the conservation and management of, tuna and tuna-like species in the IATTC Convention Area. The IATTC Convention Area is defined as waters of the EPO within the area bounded by the west coast of the Americas and by 50° N. latitude, 150° W. longitude, and 50° S. latitude. The IATTC maintains a scientific research and fishery monitoring program and regularly assesses the status of tuna, shark, and billfish stocks in the EPO to determine appropriate catch limits and other measures deemed necessary to promote sustainable fisheries and prevent the overexploitation of these stocks.

    International Obligations of the United States Under the Antigua Convention

    As a Party to the Antigua Convention and a member of the IATTC, the United States is legally bound to implement certain decisions of the IATTC. The Tuna Conventions Act (16 U.S.C. 951 et seq.), as amended on November 5, 2015, by Title II of Public Law 114-81, directs that the Secretary of Commerce, in consultation with the Secretary of State and, with respect to enforcement measures, the Secretary of the Department of Homeland Security, may promulgate such regulations as may be necessary to carry out the United States' international obligations under the Antigua Convention, including recommendations and decisions adopted by the IATTC. The Secretary of Commerce's authority to promulgate such regulations has been delegated to NMFS.

    Resolution on the Management of Shark Species

    The IATTC adopted Resolution C-16-05 by consensus at its 90th meeting in July 2016 in response to the IATTC scientific staff's conservation recommendations to adopt release requirements for sharks caught by purse seine vessels and to prohibit the use of shark lines by longline vessels. The main objective of Resolution C-16-05 is to promote the conservation of shark species in the EPO by reducing incidental catch mortalities in IATTC fisheries. Although U.S. commercial fishing vessels in the EPO do not target sharks, some are caught incidentally.

    The resolution includes release requirements for sharks caught on purse seine vessels, which is expected to increase the chance of survival. Based on summarized catch data from the IATTC, silky shark (Carcharhinus falcifornmis) and hammerhead shark (Sphyrna spp.) are among the shark species most frequently caught by purse seine vessels fishing for tuna in the IATTC Convention Area. Global concern for these species of sharks has increased in recent years as evidenced by the listing of scalloped hammerhead shark (Sphyrna lewini) in Appendix II of the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) in September 2014 and the future listing of silky shark in Appendix II in October 2017. In addition, NMFS designated the Eastern Pacific ocean distinct population segment of scalloped hammerhead shark as endangered under the Endangered Species Act (79 FR 38213; July 2014), and it is this population that is incidentally caught by tuna fishing vessels in the IATTC Convention Area.

    Resolution C-16-05 includes two components that need to be implemented through rulemaking: (1) Release requirements for sharks caught by purse seine vessels, and (2) prohibiting the use of “shark lines” on longline vessels fishing in the IATTC Convention Area.

    The first component of the Resolution calls for IATTC members and cooperating non-members (CPCs) to require purse seine vessels to follow requirements for the release of sharks caught in the IATTC Convention Area. Per the Resolution, any shark caught on a purse seine vessel in the IATTC Convention Area, whether live or dead, and that is not retained, must be promptly released unharmed, to the extent practicable, as soon as it is seen in the net or on the deck, without compromising the safety of any persons. If a shark is live when caught, the shark must be released out of the net by directly releasing it from the brailer into the ocean. Sharks that cannot be released without compromising the safety of persons or the sharks before being landed on deck must be returned to the water as soon as possible, either utilizing a ramp from the deck connecting to an opening on the side of the vessel, or through escape hatches. If ramps or escape hatches are not available, the sharks must be lowered with a sling or cargo net, using a crane or similar equipment, if available. The Resolution also includes provisions that prohibit the use of gaffs, hooks, or similar instruments in the handling of sharks, the lifting of sharks by the head, tail, gill slits, or spiracles, or by using bind wire against or inserted through the body, punching holes through the bodies of sharks (e.g., to pass a cable through for lifting the shark). In addition, the proposed rule would prohibit the towing of a whale shark (Rhincondon typus) out of a purse seine net (e.g., using towing ropes).

    The second component of the Resolution prohibits longline vessels targeting tuna or swordfish in the IATTC Convention Area from using “shark lines.” Shark lines are a type of fishing gear used to target sharks and consist of an individual hooked line or hooked lines attached to the floatline, or directly to the floats of longline gear, and deployed in the water column at depths shallower than the mainline.

    Proposed Regulations for Sharks

    This proposed rule would implement the two provisions of Resolution C-16-05, as described above, for U.S. commercial fishing vessels fishing for tuna or tuna-like species in the IATTC Convention Area. In addition, this proposed rule would also revise related regulations for accuracy and clarification purposes.

    NMFS regulations already include fishing restrictions for shark species in the IATTC Convention Area. For example, NMFS regulations already require U.S. purse seine vessels fishing for tuna or tuna-like species to release all sharks, except those being retained for consumption aboard the vessel, as soon as practicable after being identified on board the vessel during the brailing operation. In addition, regulations at 50 CFR 300.27 already require U.S. purse seine vessels to ensure reasonable steps are taken to ensure safe release of any whale shark that is encircled in a purse seine net in the IATTC Convention Area.

    This proposed rule would revise regulations at 50 CFR 300.27 to include more specific release requirements for sharks on purse seine vessels. The proposed regulations would require that any shark caught on a purse seine vessel in the IATTC Convention Area, whether live or dead, be promptly released unharmed, to the extent practicable, as soon as it is seen in the net or on the deck, without compromising the safety of any persons. The proposed regulations also include specific requirements for the release of live sharks when caught in the IATTC, as described above.

    In addition, this proposed rule would prohibit U.S. commercial longline vessels fishing for tuna or swordfish from using “shark lines” in the IATTC Convention Area. Shark lines are defined as a type of fishing gear consisting of an individual line or lines attached to the floatline or directly to the floats of longline gear and are typically used to target sharks. Although U.S. longline vessels do not use shark lines when fishing in the IATTC Convention Area, this provision of the Resolution was intended to prohibit this gear in the EPO for all IATTC CPCs.

    Classification

    The NMFS Assistant Administrator has preliminarily determined that this proposed rule is consistent with the Tuna Conventions Act and other applicable laws, subject to further consideration after public comment.

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

    There are no new collection-of-information requirements associated with this action that are subject to the Paperwork Reduction Act (PRA), and existing collection-of-information requirements still apply under the following Control Numbers: 0648-0148, 0648-0214, and 0648-0593. Notwithstanding any other provision of the law, no person is required to respond to, and no person shall be subject to penalty for failure to comply with, a collection-of-information subject to the requirements of the PRA, unless that collection-of-information displays a currently valid Office of Management and Budget control number.

    Pursuant to the Regulatory Flexibility Act, 5 U.S.C. 605(b), 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 rationale for the certification is provided in the following paragraphs.

    As described previously in the SUPPLEMENTARY INFORMATION section, the proposed regulations would implement IATTC Resolution C-16-05, which would establish fishing restrictions on U.S. purse seine and longline vessels fishing in the IATTC Convention Area.

    The United States Small Business Administration (SBA) defines a “small business” (or “small entity”) as one with annual revenue that meets or is below an established size standard. On December 29, 2015, NMFS issued a final rule establishing a small business size standard of $11 million in annual gross receipts for all businesses primarily engaged in the commercial fishing industry (NAICS 11411) for Regulatory Flexibility Act (RFA) compliance purposes only (80 FR 81194, December 29, 2015). The $11 million standard became effective on July 1, 2016, and is to be used in place of the U.S. SBA current standards of $20.5 million, $5.5 million, and $7.5 million for the finfish (NAICS 114111), shellfish (NAICS 114112), and other marine fishing (NAICS 114119) sectors of the U.S. commercial fishing industry in all NMFS rules subject to the RFA after July 1, 2016. Id. at 81194. The new standard results in fewer commercial finfish businesses being considered small.

    NMFS prepared analyses for this regulatory action in light of the new size standard. All of the entities directly regulated by this regulatory action are commercial finfish fishing businesses. Under the new size standards, the action on purse seine restriction on sharks would affect both large and small businesses, but the affected longline vessels are all considered to be small businesses.

    There are two components to the U.S. tuna purse seine fishery in the EPO: (1) Purse seine vessels with at least 363 metric tons (mt) of fish hold volume (size class 6 vessels) that typically have been based in the western and central Pacific Ocean (WCPO), and (2) coastal purse seine vessels with smaller fish hold volume that are based on the U.S. West Coast. Because this regulation would apply to purse seine vessels that catch shark, and there is no record of the coastal purse seine vessels catching shark, NMFS does not expect these regulations to impact the smaller coastal purse seine vessels.

    As of May 4, 2017, there are 17 size class 6 purse seine vessels on the IATTC Regional Vessel Register. The number of size class 6 purse seine vessels on the IATTC Regional Vessel Register has increased substantially in the past three years, due in part to uncertainty regarding fishing access pursuant to the Treaty on Fisheries between the Governments of Certain Pacific Island States and the Government of the United States of America (aka the South Pacific Tuna Treaty), for which negotiations were concluded in 2016. Size class 6 purse seine vessels land most of the yellowfin, skipjack, and bigeye tuna catch in the EPO. Ex-vessel price information for class size 6 purse seine vessels that fished exclusively in the EPO in 2015 and 2016 specific to the individual vessels are not available to NMFS because these vessels did not land on the U.S. West Coast, and the cannery receipts are not available through the IATTC. However, estimates for large purse seine vessels based in the WCPO that fish in both the EPO and WCPO may be used as a proxy for U.S. large purse seine vessels. The number of these U.S. purse seine vessels is approximated by the number with Western and Central Pacific Fisheries Commission (WCPFC) Area Endorsements, which are the NMFS-issued authorizations required to fish commercially for highly migratory species (HMS) on the high seas in the WCPFC Convention Area. As of May 2017, the number of purse seine vessels with WCPFC Area Endorsements was 37. Neither gross receipts nor ex-vessel price information specific to individual fishing vessels are available to NMFS, so NMFS applied indicative regional cannery prices—as approximations of ex-vessel prices—to annual catches of individual vessels to estimate their annual receipts. Indicative regional cannery prices are available through 2014 (developed by the Pacific Islands Forum Fisheries Agency; available at https://www.ffa.int/node/425). Using this approach, NMFS estimates that among the affected vessels, the range in annual average receipts in 2012 through 2014 was $3 million to $20 million and the median was about $13 million.

    U.S. purse seine vessels fishing in the IATTC Convention Area incidentally catch a relatively small number of sharks. Since at least 2005, the observer coverage rates in the EPO on class size 6 purse seine vessels have been at 100 percent. Logbook data from 2015 and 2016 recorded a total of 3,960 sharks incidentally caught by size class 6 purse seine vessels operating in the IATTC Convention Area, which were released alive or discarded. This resulted in an average of roughly 2.29 sharks per fishing set caught and discarded or released alive by size class 6 purse seine vessels operating in the IATTC Convention area in 2015 and 2016. The proposed regulations for shark release requirements on purse seine vessels may slow fishing operations of some purse seine vessels that incidentally catch sharks due to additional time burden for releasing them by implementing the release requirements. In addition to the additional time burden for releasing sharks, some tuna may be incidentally released when sharks are directly released out of the brailer into the ocean, if any tuna are also scooped up into the brailer along with sharks during the process. The amount of tuna incidentally released would vary depending on the position of the shark in the net in relation to the tuna, accuracy of the crew member in targeting the shark with the brailer, and how large a brailer is being used, among others factors. In addition, some large purse seine vessels may already be voluntarily following some of these release procedures, such as the best practices for release established by the International Seafood Sustainability Foundation, in the IATTC Convention Area.

    U.S. West Coast vessels with deep-set longline gear primarily target tuna species with a small percentage of swordfish and other highly migratory species taken incidentally. U.S. West Coast-based longline vessels fish primarily in the EPO and are currently restricted to fishing with deep-set longline gear outside of the U.S. West Coast EEZ. Recently, the number of Hawaii-permitted longline vessels that have landed in U.S. West Coast ports has increased from one vessel in 2006 to 18 vessels in 2016. In 2016, 931 mt of highly migratory species were landed by Hawaii permitted longline vessels with an average ex-vessel revenue of approximately $303,287 per vessel. Since at least 2005, the observer coverage rates in the EPO on deep-set longline vessels have been a minimum of 20 percent. While some sharks are caught incidentally, U.S. commercial longline vessels do not use shark lines while fishing in the EPO. As such, this proposed rule is not expected to affect these small entities.

    The proposed regulation is not expected to have a significant economic impact on a substantial number of small entities. Only some of the entities for which these proposed regulations would apply are considered small businesses; however, disproportional economic effects are not expected between affected small and large businesses. Regulations at 50 CFR 300.27 already require purse seine vessels to release all sharks, except those being retained for consumption aboard the vessel, as soon as practicable after being identified on board the vessel during the brailing operation. In addition, regulations at 50 CFR 300.27 already require purse seine vessels to ensure reasonable steps are taken to ensure safe release of any whale shark that is encircled in a purse seine net. This proposed rule would revise regulations at 50 CFR 300.27 to specify the release requirements for sharks. As stated above, U.S. longline vessels do not use shark lines while fishing for tuna or swordfish in the EPO. Therefore, the proposed regulation is not expected to impact these small entities.

    The proposed actions are not expected to substantially change the typical fishing practices of affected vessels, and any impact to the income of U.S. vessels would be minor. As a result, an Initial Regulatory Flexibility Analysis is not required, and one was not prepared for this proposed rule.

    List of Subjects in 50 CFR Part 300

    Fish, Fisheries, Fishing, Fishing vessels, International organizations, Marine resources, Reporting and recordkeeping requirements, Treaties.

    Dated: August 1, 2017. Samuel D. Rauch, III, Deputy Assistant Administrator for Regulatory Programs, National Marine Fisheries Service.

    For the reasons set out in the preamble, 50 CFR part 300 is proposed to be amended as follows:

    PART 300—INTERNATIONAL FISHERIES REGULATIONS Subpart C—Eastern Pacific Tuna Fisheries 1. The authority citation for part 300, subpart C, continues to read as follows: Authority:

    16 U.S.C. 951 et seq.

    2. In § 300.21, add a definition for “Shark line” in alphabetical order to read as follows:
    § 300.21 Definitions.

    Shark line means: A type of fishing gear used to target sharks and consisting of an individual hooked line or hooked lines attached to the floatline or directly to the floats of longline gear and deployed in the water column at depths shallower than the mainline.

    3. In § 300.24, revise paragraphs (w), (x), (cc), and (dd), and add paragraphs (jj) through (kk) to read as follows:
    § 300.24 Prohibitions.

    (w) Set or attempt to set a purse seine on or around a whale shark (Rhincodon typus) in contravention of § 300.27(g).

    (x) Fail to release a whale shark encircled in a purse seine net of a fishing vessel as required in § 300.27(h).

    (cc) To retain on board, transship, store, land, sell, or offer for sale any part or whole carcass of a mobulid ray, as described in § 300.27(i).

    (dd) Fail to handle or release a mobulid ray as required in § 300.27(j).

    (jj) Fail to handle or release a shark as required in § 300.27(k).

    (kk) Use a shark line in contravention of § 300.27(l).

    4. In § 300.27, revise paragraphs (b) and (h), and add paragraphs (k) and (l) to read as follows:
    § 300.27 Incidental catch and tuna retention requirements.

    (b) Release requirements for non-tuna species on purse seine vessels. All purse seine vessels must release all billfish, ray (not including mobulid rays, which are subject to paragraph (i) of this section), dorado (Coryphaena hippurus), and other non-tuna fish species, except those being retained for consumption aboard the vessel, as soon as practicable after being identified on board the vessel during the brailing operation. Sharks caught in the IATTC Convention Area and that are not retained for consumption aboard the vessel (other than silky shark, oceanic whitetip shark, and whale shark, which may not be retained for consumption) must be released according to the requirements in paragraph (k) of this section.

    (h) Whale shark release. The crew, operator, and owner of a fishing vessel of the United States commercially fishing for tuna in the Convention Area must release as soon as possible, any whale shark that is encircled in a purse seine net, and must ensure that all reasonable steps are taken to ensure its safe release. No whale shark may be towed out of a purse seine net (e.g., using towing ropes).

    (k) Shark handling and release requirements for purse seine vessels. The crew, operator, and owner of a U.S. commercial purse seine fishing vessel must promptly release unharmed, to the extent practicable, any shark (whether live or dead) caught in the IATTC Convention Area, as soon as it is seen in the net or on the deck, without compromising the safety of any persons. If a shark is live when caught, the crew, operator, or owner must follow release procedures in the following two paragraphs.

    (1) Sharks must be released out of the purse seine net by directly releasing the shark from the brailer into the ocean. Sharks that cannot be released without compromising the safety of persons or the sharks before being landed on deck must be returned to the water as soon as possible, either utilizing a ramp from the deck connecting to an opening on the side of the boat, or through escape hatches. If ramps or escape hatches are not available, the sharks must be lowered with a sling or cargo net, using a crane or similar equipment, if available.

    (2) No shark may be gaffed or hooked, lifted by the head, tail, gill slits or spiracles, or lifted by using bind wire against or inserted through the body, and no holes may be punched through the bodies of sharks (e.g., to pass a cable through for lifting the shark).

    (l) Shark line prohibition for longline vessels. Any U.S. longline vessel used to fish for tuna or swordfish is prohibited from using any shark line in the IATTC Convention Area.

    [FR Doc. 2017-16448 Filed 8-4-17; 8:45 am] BILLING CODE 3510-22-P
    82 150 Monday, August 7, 2017 Notices DEPARTMENT OF AGRICULTURE Submission for OMB Review; Comment Request August 2, 2017.

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

    Comments regarding this information collection received by September 6, 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.

    Office of Advocacy and Outreach

    Title: USDA/HSI Scholars Program Applications.

    OMB Control Number: 0503-New.

    Summary of Collection: The purpose of the U.S. Department of Agriculture (USDA) Hispanic-Serving Institutions (HSI) Scholars Program is to strengthen the long-term partnership between USDA and the HSIs; to increase the number of students studying and graduating in food, agriculture, natural resources, and other related fields of study, to develop a pool of scientists and professionals to fill jobs in the food, agricultural, natural resources system; and to create a talent pipeline for USDA. The USDA/HSI Scholars Program is a joint human capital initiative between the USDA and Hispanic-Serving Institutions. Through the program, USDA will offer scholarships to high school and college students who are seeking a bachelor's degree in the field of agriculture, food, or natural resource sciences and related disciplines at Hispanic-Serving Institutions. The USDA/HSI Scholars Program will offer scholarships and internships for a period of up to 4 years. The authority to collect this information is under 5 CFR 213.3102(r).

    Need and Use of the Information: Information will be collected to determine the eligibility of applicants to the USDA/HSI Scholars Program. Each applicant to the program will be required to apply to announcements of the USDA/HSI Scholars Program and submit an application with required documentation. The required documentation will include: (1) A resume; (2) Proof of acceptance or enrollment in school, a letter of acceptance, or proof of registration, or letter from school official on official letterhead; (3) A copy of the last high school or college transcript; and (4) Two letters of recommendation. The collected information is needed to review all components of the application for completeness; and determine if the application meets the minimum eligibility requirements to be considered for the USDA/HSI Scholars Program. Also the collected information will be used to determine if the applicants are a good fit for the university and agency based on their proposed major, interest, future academic/professional goals, and grade point average. Without the information the USDA/HSI Scholars Program would not be able to function consistently.

    Description of Respondents: Individuals or households.

    Number of Respondents: 600.

    Frequency of Responses: Reporting: Annually.

    Total Burden Hours: 600.

    Ruth Brown, Departmental Information Collection Clearance Officer.
    [FR Doc. 2017-16544 Filed 8-4-17; 8:45 am] BILLING CODE 3412-88-P
    DEPARTMENT OF COMMERCE U.S. Census Bureau Proposed Information Collection; Comment Request; Annual Business Survey (ABS) 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 October 6, 2017.

    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 Patrice Norman, U.S. Census Bureau, EWD, 8K151, Washington, DC 20233-6600, (301) 763-7198, [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Abstract

    The U.S. Census Bureau, with support from the National Science Foundation (NSF), plans to conduct the Annual Business Survey (ABS) for the 2017-2021 survey years. The ABS is a new survey designed to combine Census Bureau firm-level collections to reduce respondent burden, increase data quality, reduce operational costs, and operate more efficiently. The ABS replaces the five-year Survey of Business Owners (SBO) for employer businesses, the Annual Survey of Entrepreneurs (ASE), and the Business R&D and Innovation for Microbusinesses (BRDI-M) surveys. The Survey of Business Owners has been conducted as part of the economic census every five years since 1972 to collect selected economic and demographic characteristics for businesses and business owners by gender, ethnicity, race, and veteran status for both employer and nonemployer businesses. The Annual Survey of Entrepreneurs was conducted for three reference years (2014, 2015, and 2016) as a supplement to the SBO to provide more frequent data on economic and demographic characteristics for businesses and business owners by gender, ethnicity, race, and veteran status for employer businesses. The Business R&D and Innovation for Microbusinesses survey was first fielded in 2016 as an expansion to the Business R&D and Innovation Survey (BRDI-S) to measure firm innovation and investigate the incidence of R&D activities in growing sectors, such as small business enterprises not covered by BRDIS. Detailed R&D information for businesses with 10 or more employees will continue to be collected separately on the BRDIS. Statistics from the new ABS will be used by government program officials, industry organization leaders, economic and social analysts, business entrepreneurs, and domestic and foreign researchers in academia, business, and government. Estimates produced on owner demographic data may be used to assess business assistance needs, allocate available program resources, and create a framework for planning, directing, and assessing programs that promote the activities of disadvantaged groups; to assess minority-owned businesses by industry and area and to educate industry associations, corporations, and government entities; to analyze business operations in comparison to similar firms, compute market share, and assess business growth and future prospects. Estimates produced on research and development and innovation may be used to compare R&D costs across industries, determine where R&D activity is conducted geographically, and identify the types of businesses with R&D; to contribute to the Bureau of Economic Analysis (BEA) system of national accounts; to increase investments in research and development, strengthen education, and encourage entrepreneurship; and to compare business innovation in the United States to that of other countries.

    The ABS covers all domestic, nonfarm employer businesses with operations during the survey year. The ABS will provide the only comprehensive data on business owner demographics and business characteristics, including financing, research and development (for microbusinesses), and innovation. Nonemployer businesses are not in scope for the ABS. The Census Bureau will submit a separate clearance for approval to collect business and owner characteristics from nonemployer businesses if it is determined that a collection is needed to produce those estimates. The ABS will collect the following information from employer businesses:

    • Owner characteristics, including the gender, ethnicity, race, and veteran status of the principal owner(s) from all firms in the sample

    • Various business characteristics, including financing from all firms in the sample

    • Research and development activity and costs from firms with less than 10 employees

    • Innovation practices from all firms in the sample

    Additional owner topics include military service, owner acquisition, job functions, number of hours worked, primary income, prior business ownership, age of owner, education and field of degree, citizenship and place of birth, and owner's reason for owning the business. Other business topics include number of owners and percent ownership, family owned and operated, business aspirations, funding sources, profitability, types of customers, types of workers, employee benefits, home operation, Web site use, and business activity. Starting with the 2018 survey, the ABS may include new module questions each year based on relevant business topics. Potential topics include technological advances, Internet usage, management and business practices, exporting practices, and globalization.

    The draft content for the ABS will be cognitively tested with approximately 20 businesses under a separate OMB generic clearance. The questionnaire and interview protocol will be used to assess the feasibility and merit of suggested changes that arise from the testing.

    The 2017 ABS will sample approximately 850,000 employer businesses to produce more detailed statistics. Annually from 2018-2021, the survey sample will be reduced to approximately 300,000 businesses to reduce respondent burden. Businesses that reported business activity on Internal Revenue Service tax forms 941, “Employer's Quarterly Federal Tax Return”; 944, “Employer's Annual Federal Tax Return”; or any one of the 1120 corporate tax forms will be eligible for selection.

    II. Method of Collection

    The ABS will be collected using only electronic instruments. Respondents will receive a letter notifying them of their requirement to respond and how to access the survey. Letters will be mailed from the Census Bureau's National Processing Center in Jeffersonville, Indiana. Responses will be due approximately 30 days from receipt. Select businesses will receive a due date reminder via a letter prior to the due date. Additionally, two mail follow-ups to nonrespondents will be conducted at approximately one-month intervals. Select nonrespondents will receive a certified mailing for the second follow-up if needed.

    III. Data

    OMB Control Number: 0607-XXXX.

    Form Number(s): This electronic-only collection will not utilize paper forms.

    Type of Review: Regular submission.

    Affected Public: Large and small employer businesses.

    Estimated Number of Respondents: 850,000 employer businesses for 2017; 300,000 employer businesses for 2018-2021.

    Estimated Time per Response: 35 minutes.

    Estimated Total Annual Burden Hours: 495,833 for 2017; 175,000 for 2018-2021.

    Estimated Total Annual Cost to Public: $0.

    Respondent's Obligation: Mandatory.

    Legal Authority: Title 13, United States Code, Sections 8(b), 131, and 182; and Title 42, United States Code, Sections 1861-76 (National Science Foundation Act of 1950, as amended).

    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. 2017-16605 Filed 8-4-17; 8:45 am] BILLING CODE 3510-07-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-570-992] Monosodium Glutamate From the People's Republic of China: Preliminary Results of the Antidumping Duty Administrative Review; 2015-2016 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 monosodium glutamate (MSG) from the People's Republic of China (PRC) covering the period of review (POR) November 1, 2015, through October 31, 2016. This review covers 27 manufacturers/exporters (the companies) of the subject merchandise. Because none of these companies filed a separate rate application (SRA) and/or a separate rate certification (SRC), the Department preliminarily finds that the companies are part of the PRC-wide entity. We invite interested parties to comment on these preliminary results.

    DATES:

    Applicable August 7, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Chien-Min Yang, AD/CVD Operations, Office VII, Enforcement and Compliance, International Trade Administration, Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone at (202) 482-5484.

    SUPPLEMENTARY INFORMATION: Background

    On November 4, 2016, the Department published a notice of opportunity to request an administrative review of the antidumping duty order on MSG from the PRC.1 In response, on November 29, 2016, Ajinomoto North America, Inc. (the petitioner) requested a review of 27 companies.2 The Department initiated a review of all 27 companies on January 13, 2017.3 For a list of these companies, please see Appendix I. The deadline for interested parties to submit an SRA or an SRC was February 13, 2017.4 No party timely submitted an SRA or an SRC. Thereafter, the petitioner submitted comments on the Department's selection of respondents, encouraging the Department to employ its customary policy to treat companies as a part of the country-wide entity in reviews where no party submits an SRA or SRC.5

    1See Antidumping or Countervailing Duty Order, Finding, or Suspended Investigation; Opportunity To Request Administrative Review, 81 FR 76920 (November 4, 2016).

    2See Ajinomoto's letter, “Monosodium Glutamate from China: Request for Administrative Review,” (November 29, 2016), at attachment 1 which lists 27 companies for which Ajinomoto sought a review.

    3See Initiation of Antidumping and Countervailing Duty Administrative Reviews, 82 FR 4294 (January 13, 2017) (Initiation Notice).

    4See Initiation Notice.

    5See Ajinomoto's letter, “MSG from China: Comments on Respondent Selection,” (February 15, 2017).

    Scope of the Order

    The product covered by this order is MSG, whether or not blended or in solution with other products. Specifically, MSG that has been blended or is in solution with other product(s) is included in this scope when the resulting mix contains 15 percent or more of MSG by dry weight. Products with which MSG may be blended include, but are not limited to, salts, sugars, starches, maltodextrins, and various seasonings. Further, MSG is included in this order regardless of physical form (including, but not limited to, in monohydrate or anhydrous form, or as substrates, solutions, dry powders of any particle size, or unfinished forms such as MSG slurry), end-use application, or packaging. MSG in monohydrate form has a molecular formula of C5H8NO4Na-H2O, a Chemical Abstract Service (CAS) registry number of 6106-04-3, and a Unique Ingredient Identifier (UNII) number of W81N5U6R6U. MSG in anhydrous form has a molecular formula of C5H8NO4Na, a CAS registry number of l42-47-2, and a UNII number of C3C196L9FG. Merchandise covered by the scope of this order is currently classified in the Harmonized Tariff Schedule of the United States (HTSUS) at subheading 2922.42.10.00. Merchandise subject to the order may also enter under HTS subheadings 2922.42.50.00, 2103.90.72.00, 2103.90.74.00, 2103.90.78.00, 2103.90.80.00, and 2103.90.90.91. The tariff classifications, CAS registry numbers, and UNII numbers are provided for convenience and customs purposes; however, the written description of the scope is dispositive.6

    6See Monosodium Glutamate from the People's Republic of China: Second Amended Final Determination of Sales at Less Than Fair Value and Amended Antidumping Order, 80 FR 487 (January 6, 2015).

    Methodology

    The Department is conducting this review in accordance with section 751(a)(1)(B) of the Tariff Act of 1930, as amended (the Act), and 19 CFR 351.213.

    Preliminary Results of Review

    The Department's policy regarding conditional review of the PRC-wide entity applies to this administrative review.7 Under this policy, the PRC-wide entity will not be under review unless a party specifically requests, or the Department self-initiates, a review of the entity. The Department preliminarily determines that the 27 companies subject to review are part of the PRC-wide entity. None of the 27 companies filed an SRA or an SRC. No review has been requested for the PRC-wide entity. Therefore, the Department preliminarily determines that these companies have not demonstrated their eligibility for separate rate status and are part of the PRC-wide entity. The PRC-wide entity rate is 40.41 percent.8

    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, 65970 (November 4, 2013).

    8See Monosodium Glutamate from the People's Republic of China: Second Amended Final Determination of Sales at Less Than Fair Value and Amended Antidumping Duty Order, 80 FR 487 (January 6, 2015).

    Public Comment

    Interested parties are invited to comment on the preliminary results and may submit case briefs and/or written comments, filed electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS), within 30 days after the date of publication of these preliminary results of review.9 ACCESS is available to registered users at http://access.trade.gov and is available to all parties in the Central Records Unit in Room B8024 of the main Commerce building. Rebuttal briefs, limited to issues raised in the case briefs, must be filed within five days after the time limit for filing case briefs.10 Parties who submit case or rebuttal briefs in this proceeding are requested to submit with each argument a statement of the issue, a brief summary of the argument, and a table of authorities.11

    9See 19 CFR 351.309(c)(1)(ii).

    10See 19 CFR 351.309(d)(1) and (2).

    11See 19 CFR 351.309(c) and (d); see also 19 CFR 351.303 (for general filing requirements).

    Interested parties who wish to request a hearing, or to participate if one is requested, must submit a written request to the Department within 30 days of the date of publication of this notice.12 Requests should contain: (1) The party's name, address and telephone number; (2) The number of participants; and (3) a list of issues to be discussed. 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, 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 20230.13 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, unless extended, pursuant to section 751(a)(3)(A) of the Act.

    12See 19 CFR 351.310(c)

    13See 19 CFR 310(d).

    Assessment Rates

    Upon issuance of the final results of this review, the Department will determine, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries of subject merchandise covered by this review.14 We intend to instruct CBP to liquidate entries containing subject merchandise exported by the companies under review that we determine in the final results to be part of the PRC-wide entity at the PRC-wide rate of 40.41 percent. The Department intends to issue assessment instructions to CBP 15 days after the date of publication of this review in the Federal Register.15

    14See 19 CFR 351.212(b)(1).

    15 For a full discussion of this practice, see Non-Market Economy Antidumping Proceedings: Assessment of Antidumping Duties, 76 FR 65694 (October 24, 2011).

    Cash Deposit Requirements

    The following cash deposit requirements will be effective upon publication of the final results of this review for shipments of the subject merchandise from the PRC entered, or withdrawn from warehouse, for consumption on or after the publication date, as provided by sections 751(a)(2)(C) of the Act: (1) For companies that have a separate rate, 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); (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; (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 that for the PRC-wide entity (i.e., 40.41 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 reminder to importers of their responsibility under 19 CFR 315.402(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 preliminary results in accordance with sections 751(a)(1) and 777(i) of the Act, and 19 CFR 351.213(h) and 351.221(b)(4).

    Dated: August 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

    List of Companies Covered by This Review 1. Anhui Fresh Taste International Trade Co., Ltd. 2. Baoji Fufeng Biotechnologies Co., Ltd. 3. Blu Logistics (China) Co., Ltd. 4. Bonroy Group Limited 5. Forehigh Trade and Industry Co., Ltd. 6. Fujian Province Jianyang Wuyi MSG Co., Ltd. 7. Golden Banyan Foodstuffs Industry Co., Ltd. 8. Henan Lotus Flower Gourmet Powder Co. 9. Hong Kong Sungiven International Food Co., Limited 10. Hulunbeier Northeast Fufeng Biotechnologies Co., Ltd. 11. K&S Industry Limited 12. King Cheong Hong International 13. Langfang Meihua Bio-Technology Co., Ltd. 14. Liangshan Linghua Biotechnology Co., Ltd. 15. Lotus Health Industry Holding Group 16. Meihua Group International Trading (Hong Kong) Limited 17. Meihua Holdings Group Co., Ltd., Bazhou Branch 18. Neimenggu Fufeng Biotechnologies Co., Ltd. 19. Pudong Prime Int'l Logistics, Inc. 20. Qinhuangdao Xingtai Trade Co., Ltd. 21. S.D. Linghua M.S.G. Incorporated Co. 22. Shandong Linghua Monosodium Glutamate Incorporated Company 23. Shanghai Totole Food Ltd. 24. Shijiazhuang Standard Imp & Exp Co., Ltd. 25. Sunrise (HK) International Enterprise Limited 26. Tongliao Meihua Biological Sci-Tech Co., Ltd. 27. Zhejiang Medicines & Health [FR Doc. 2017-16576 Filed 8-4-17; 8:45 am] BILLING CODE 3510-DS-P DEPARTMENT OF COMMERCE International Trade Administration [A-520-804] Certain Steel Nails From the United Arab Emirates: 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 certain steel nails from the United Arab Emirates (UAE) would be likely to lead to continuation or recurrence of dumping at the levels indicated in the “Final Results of Review” section of this notice.

    DATES:

    Applicable August 7, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Annathea Cook, AD/CVD Operations, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-0250.

    SUPPLEMENTARY INFORMATION:

    On April 27, 2011, the Department of Commerce (Department) published the notice of the AD Order on nails from the UAE.1 On April 3, 2017, the Department published the notice of initiation of the first sunset review of the AD Order, pursuant to section 751(c) of the Tariff Act of 1930, as amended (Act).2 On April 4, 2017, the Department received a notice of intent to participate from one domestic interested party: Mid Continent Steel & Wire, Inc. (Mid Continent) within the deadline specified in 19 CFR 351.218(d)(1)(i).3 Mid Continent claimed interested party status under section 771(9)(C) of the Act, as a manufacturer in the United States of a domestic like product. On May 4, 2017, the Department received a complete and adequate substantive response from Mid Continent within the 30-day deadline specified in 19 CFR 351.218(d)(3)(i).4 The Department received no substantive responses from respondent interested parties. 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 sunset review of the AD Order.

    1See Certain Steel Nails from the United Arab Emirates: Amended Final Determination of Sales at Less Than Fair Value and Antidumping Duty Order, 77 FR 27421 (May 10, 2012) (AD Order).

    2See Initiation of Five-Year (Sunset) Reviews, 82 FR 16159 (April 3, 2017) (Notice of Initiation).

    3See Mid Continent's submission “Re: Steel Nails from the United Arab Emirates: Entry of Appearance, Notice of Intent to Participate in Review, and APO Application” (April 4 2017).

    4See Mid Continent's submission “Re: Certain Steel Nails from the United Arab Emirates: Substantive Response to Notice of Initiation of Sunset review” (May 3, 2017).

    Scope of the Order

    The merchandise covered by this order includes certain steel nails having a shaft length up to 12 inches. These imports are currently classified under subheadings 7317.00.55, 7317.00.65, and 7317.00.75 of the Harmonized Tariff Schedule of the United States (HTSUS). The HTSUS subheading is provided for convenience and customs purposes. The written product description remains dispositive.5

    5 For a full description of the scope of the AD Order, see Memorandum to Ronald K. Lorentzen, Acting Assistant Secretary for Enforcement and Compliance, from Gary Taverman, Assistant Secretary for Enforcement and Compliance for Antidumping and Countervailing Duty Operations, “First Expedited Sunset Review of the Antidumping Duty Order on Certain Steel Nails from the United Arab Emirates: Issues and Decision Memorandum for the Final Results,” dated concurrently with, and adopted by, this notice (Issues and Decision Memorandum).

    Analysis of Comments Received

    A complete discussion of all issues raised in this sunset review, including the likelihood of continuation or recurrence of dumping in the event of revocation of the AD Order and the magnitude of the margins likely to prevail if the order were revoked, is provided in the Issues and Decision Memorandum, which is hereby adopted by this notice.6 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 Services System (ACCESS). ACCESS is available to registered users at http://access.trade.gov and to all parties in the Central Records Unit, room B0824 of the main Department of Commerce building. In addition, a complete version of the Issues and Decision Memorandum can be accessed 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.

    6See Issues and Decision Memorandum.

    Final Results of Sunset Review

    Pursuant to section 751(c)(1) and 752(c)(1) and (3) of the Act, the Department determines that revocation of the AD Order 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 184.41 percent.

    Notification to Interested Parties

    This notice serves as the only reminder to parties subject to administrative protective order (APO) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305. Timely 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, 19 CFR 351.218, and 19 CFR 351.221(c)(5)(ii).

    Dated: July 28, 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 Review VIII. Recommendation
    [FR Doc. 2017-16500 Filed 8-4-17; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-570-972; A-583-848] Certain Stilbenic Optical Brightening Agents From the People's Republic of China and Taiwan: Final Results of the Expedited Sunset Reviews of the Antidumping Duty Orders AGENCY:

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

    SUMMARY:

    As a result of these sunset reviews, the Department of Commerce (the Department) finds that revocation of the antidumping duty orders on stilbenic optical brightening agents (stilbenic OBAs) from the People's Republic of China (PRC) and Taiwan would likely lead to continuation or recurrence of dumping, at the levels indicated in the “Final Results of Sunset Reviews” section of this notice.

    DATES:

    Effective August 7, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Eli Lovely, AD/CVD Operations, Office IV, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-1593.

    SUPPLEMENTARY INFORMATION:

    Background

    On May 10, 2012, the Department published the antidumping duty orders on stilbenic OBAs from the PRC and Taiwan.1 On April 3, 2017, the Department initiated the first sunset reviews of the antidumping duty orders on stilbenic OBAs from the PRC and Taiwan pursuant to section 751(c) of the Tariff Act of 1930, as amended (the Act).2 On April 18, 2017, the Department received a timely notice of intent to participate in the sunset reviews from Archroma, U.S., Inc. (Archroma), the descendant company of the petitioner in the original investigation, within the 15-day period specified in 19 CFR 351.218(d)(1)(i).3 On May 3, 2017, domestic interested parties filed a timely substantive response with the Department pursuant to 19 CFR 351.218(d)(3)(i).4 The Department did not receive a substantive response from any respondent interested party. 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 expedited (120-day) sunset reviews of the Orders.

    1See Certain Stilbenic Optical Brightening Agents From the People's Republic of China: Amended Final Determination of Sales at Less Than Fair Value and Antidumping Duty Order, 77 FR 27423 (May 10, 2012); and Certain Stilbenic Optical Brightening Agents From Taiwan: Amended Final Determination of Sales at Less Than Fair Value and Antidumping Duty Order, 77 FR 27419 (May 10, 2012) (Orders).

    2See Initiation of Five-Year (Sunset) Reviews, 82 FR 16159 (April 3, 2017).

    3 Berwick Offray LLC claimed interested party status as a manufacturer of the domestic like product, pursuant to section 771(9)(C) of the Act.

    4See Certain Stilbenic Optical Brightening Agents from China. Case No. A-570-972—Petitioner's Substantive Response, (May 3, 2017), and Certain Stilbenic Optical Brightening Agents from Taiwan, Case No. A-583-848—Petitioner's Substantive Response, (May 3, 2017).

    Scope of the Orders

    The merchandise subject to these Orders is final stilbenic OBA products, as well as intermediate products that are themselves triazinylaminostilbenes produced during the synthesis of stilbenic OBA products. These stilbenic OBAs are classifiable under subheading 3204.20.8000 of the Harmonized Tariff Schedule of the United States (HTS US), but they may also enter under subheadings 2933.69.6050, 2921.59.4000 and 2921.59.8090. The Decision Memorandum, which is hereby adopted by this notice, provides a full description of the scope of the Orders. 5

    5See the “Issues and Decision Memorandum for the Expedited Sunset Review of the Antidumping Duty Order on Certain Stilbenic Optical Brightening Agents from the People's Republic of China and Taiwan” from Abdelali Elouaradia, Director, Office IV, Antidumping and Countervailing Duty Operations, to Gary Taverman Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, dated concurrently with, and hereby adopted by, this notice (Decision Memorandum).

    Analysis of Comments Received

    All issues raised in these sunset reviews are addressed in the Decision Memorandum. The issues discussed in the Decision Memorandum include the likelihood of continuation or recurrence of dumping and the magnitude of the margins likely to prevail if the Orders were to be revoked.

    The 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 Decision Memorandum can be accessed at http://enforcement.trade.gov/frn/. The signed Decision Memorandum and the electronic version of the Decision Memorandum are identical in content.

    Final Results of Sunset Reviews

    Pursuant to sections 751(c)(1) and 752(c)(1) and (3) of the Act, the Department determines that revocation of the Orders would likely lead to continuation or recurrence of dumping, and that the magnitude of the margin of dumping likely to prevail if the Orders are revoked would be up to 106.17 percent for the PRC and up to 6.19 percent for Taiwan.

    Notification Regarding Administrative Protective Orders

    This notice also serves as the only reminder to parties subject to administrative protective order (APO) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305. Timely notification of the return or destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.

    Notification to Interested Parties

    We are issuing and publishing these final results and notice in accordance with sections 751(c), 752(c), and 777(i)(1) of the Act and 19 CFR 351.218 and 19 CFR 351.221(c)(5)(ii).

    Dated: August 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—List of Topics Discussed in the Issues and Decision Memorandum I. Summary II. Background III. Scope of the Orders IV. History of the Orders 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 Reviews VIII. Recommendation
    [FR Doc. 2017-16573 Filed 8-4-17; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration Meeting of the President's Advisory Council on Doing Business in Africa (PAC-DBIA) AGENCY:

    International Trade Administration, U.S. Department of Commerce.

    ACTION:

    Notice of an Open Meeting of the President's Advisory Council on Doing Business in Africa (PAC-DBIA).

    SUMMARY:

    The President's Advisory Council on Doing Business in Africa (Council) will hold a meeting via teleconference, during which the Secretary of Commerce will provide feedback on the Council's introductory letter to the President, submitted in February 2017, and published at http://trade.gov/pac-dbia/recmeet.asp. The Secretary will also provide formal direction to the Council for the next phase of analysis and recommendations to be requested on behalf of the President. The final agenda for the meeting will be posted at least one week in advance of the meeting on the Council's Web site at http://trade.gov/pac-dbia.

    DATES:

    This teleconference will be held on August 22, 2017, 2:00-3:00 p.m. (EDT). The deadline for members of the public to register to join the meeting in listen mode or to submit comments for consideration at the meeting is 5:00 p.m. (EDT), August 15, 2017.

    ADDRESSES:

    The meeting will be held by conference call. The call-in number and passcode will be provided by email to registrants. Requests to register (including for auxiliary aids) and any written comments should be submitted by the deadline to: President's Advisory Council on Doing Business in Africa, U.S. Department of Commerce, Room 22004, 1401 Constitution Avenue NW., Washington, DC 20230, or by email to [email protected] Members of the public are encouraged to submit registration requests and written comments via email to ensure timely receipt.

    FOR FURTHER INFORMATION CONTACT:

    Giancarlo Cavallo or Ashley Bubna, Designated Federal Officers, President's Advisory Council on Doing Business in Africa, Department of Commerce, 1401 Constitution Ave. NW., Room 22004, Washington, DC 20230 telephone: 202-482-2091, email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Background: The President's Advisory Council on Doing Business in Africa was established on November 4, 2014, to advise the President, through the Secretary of Commerce, on strengthening commercial engagement between the United States and Africa. The Council's charter was renewed for a second, two-year term in September 2016. This Council is established in accordance with the provisions of the Federal Advisory Committee Act (FACA), as amended, 5 U.S.C. App.

    Public Submissions: The public is invited to submit written statements to the Council. Statements must be received by 5:00 p.m. August 15, 2017 by either of the following methods:

    a. Electronic Submissions

    Submit statements electronically to Giancarlo Cavallo and Ashley Bubna, Designated Federal Officers, President's Advisory Council on Doing Business in Africa, via email: [email protected]

    b. Paper Submissions

    Send paper statements to Giancarlo Cavallo and Ashley Bubna, Designated Federal Officers, President's Advisory Council on Doing Business in Africa, Department of Commerce, 1401 Constitution Ave. NW., Room 22004, Washington, DC 20230.

    Statements will be provided to the members in advance of the meeting for consideration and also will be posted on the President's Advisory Council on Doing Business in Africa Web site (http://trade.gov/pac-dbia) without change, including any business or personal information provided such as names, addresses, email addresses, or telephone numbers. All statements received, including attachments and other supporting materials, are part of the public record and subject to public disclosure. You should submit only information that you wish to make publicly available.

    Meeting minutes: Copies of the Council's meeting minutes will be available within ninety (90) days of the meeting on the Council's Web site at http://trade.gov/pac-dbia.

    Dated: August 2, 2017. Fred Stewart, Director, Office of Africa.
    [FR Doc. 2017-16610 Filed 8-4-17; 8:45 am] BILLING CODE 3510-DR-P
    DEPARTMENT OF COMMERCE International Trade Administration [C-570-984] Drawn Stainless Steel Sinks From the People's Republic of China: Notice of Rescission of Countervailing Duty Administrative Review, 2016 AGENCY:

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

    SUMMARY:

    The Department of Commerce (the Department) is rescinding the administrative review of the countervailing duty (CVD) order on drawn stainless steel sinks (sinks) from the People's Republic of China (PRC) for the period January 1, 2016, through December 31, 2016, based on the timely withdrawal of the request for review.

    DATES:

    Applicable August 7, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Andrew Medley, AD/CVD Operations, Office II, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-4987.

    SUPPLEMENTARY INFORMATION:

    Background

    On April 3, 2017, the Department published in the Federal Register a notice of opportunity to request an administrative review of the CVD order on sinks from the PRC for the period January 1, 2016, through December 31, 2016.1 On April 28, 2017, the Department received a timely request, in accordance with section 751(a) of the Tariff Act of 1930, as amended (the Act), from Zhongshan Superte Kitchenware Co., Ltd. (Superte), an exporter of subject merchandise, to conduct an administrative review of this CVD order.2 Based upon this request, on June 7, 2017, in accordance with section 751(a) of the Act, the Department published in the Federal Register a notice of initiation of administrative review for this CVD order with respect to Superte.3 On June 26, 2017, Superte timely withdrew its request for an administrative review.4

    1See Antidumping or Countervailing Duty Order, Finding, or Suspended Investigation; Opportunity to Request Administrative Review, 82 FR 16163 (April 3, 2017).

    2See Superte's April 28, 2017, Request for CVD Administrative Review.

    3See Initiation of Antidumping and Countervailing Duty Administrative Reviews, 82 FR 26444 (June 7, 2017) (Initiation Notice).

    4See Superte's June 26, 2017, Withdrawal of Administrative Review Request.

    Rescission Review

    Pursuant to 19 CFR 351.213(d)(1), the Secretary will rescind an administrative review, in whole or in part, if a party who requested the review withdraws the request within 90 days of the date of publication of the notice of initiation of the requested review. As noted above, Superte withdrew its request for review by the 90-day deadline. No other party requested an administrative review of Superte. Accordingly, we are rescinding the administrative review of the CVD order on sinks from the PRC covering the period January 1, 2016, through December 31, 2016.

    Assessment

    The Department will instruct Customs and Border Protection (CBP) to assess countervailing duties on all appropriate entries at a rate equal to the cash deposit of estimated countervailing duties required at the time of entry, or withdrawal from warehouse, for consumption, during the period January 1, 2016, through December 31, 2016, in accordance with 19 CFR 351.212(c)(1)(i). The Department intends to issue appropriate assessment instructions directly to CBP 15 days after publication of this notice in the Federal Register.

    Notification Regarding Administrative Protective Order

    This notice serves as a reminder to parties subject to administrative protective order (APO) of their responsibility concerning the return or destruction of proprietary information disclosed under an APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of the return/destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.

    This notice is issued and published in accordance with sections 751 of the Act and 19 CFR 351.213(d)(4).

    Dated: August 1, 2017 James Maeder, Senior Director performing the duties of Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations.
    [FR Doc. 2017-16572 Filed 8-4-17; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-533-824] Polyethylene Terephthalate Film, Sheet, and Strip From India: Preliminary Results and Partial Rescission of Antidumping Duty Administrative Review; 2015-2016 AGENCY:

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

    SUMMARY:

    The Department of Commerce (the Department) is conducting an administrative review of the antidumping duty (AD) order on polyethylene terephthalate film, sheet, and strip (PET Film) from India. The period of review (POR) is July 1, 2015, through June 30, 2016. The Department preliminarily determines that Jindal Poly Films Limited of India did, but that SRF Limited did not, make sales of subject merchandise at prices below normal value (NV) during the POR. The preliminary results are listed below in the section titled “Preliminary Results of Review.” Interested parties are invited to comment on these preliminary results.

    DATES:

    Applicable August 7, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Jacqueline Arrowsmith; AD/CVD Operations, Office VII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-5255.

    SUPPLEMENTARY INFORMATION:

    Scope of the Order

    The products covered by this order are all gauges of raw, pretreated, or primed polyethylene terephthalate film, sheet and strip, whether extruded or coextruded. Excluded are metallized films and other finished films that have had at least one of their surfaces modified by the application of a performance-enhancing resinous or inorganic layer of more than 0.00001 inches thick. Imports of PET film are classifiable in the Harmonized Tariff Schedule of the United States (HTSUS) under item number 3920.62.00.90. HTSUS subheadings are provided for convenience and customs purposes. The written description of the scope of the order is dispositive.

    Background

    DuPont Teijin Films, Mitsubishi Polyester Film Inc., and SKC, Inc. (the petitioners) requested reviews of Ester Industries Limited (Ester), Garware Polyester Ltd. (Garware), Polyplex Corporation Ltd. (Polyplex Ltd.), SRF Limited (SRF), Jindal Poly Films Limited of lndia (Jindal),1 and Vacmet.2 Polyplex USA and Flex USA requested reviews of SRF, Jindal, Garware, Ester, MTZ Polyesters Ltd. (MTZ), Vacmet India Limited, Uflex Ltd. and Polyplex Ltd.3 Jindal and SRF each self-requested.4 Based on these timely requests, the Department initiated a review of ten companies in this proceeding.5

    1 On May 23, 2017, the Department sent Jindal Poly Films Ltd. (India) a supplemental questionnaire requesting clarification of its name. See Department Letter re: Jindal Poly Films Ltd. (India)'s Name, dated May 23, 2017. Based on Jindal Poly Films Ltd. (India)'s response, we have determined that it is the same company as Jindal Poly Films of India. See Jindal Poly Films Ltd. (India)'s May 25, 2017 Response. Accordingly, Jindal Poly Films Ltd. (India) and Jindal Poly Films of India will be referred to as “Jindal” for the remainder of this notice.

    2See Petitioners' Letter, “Polyethylene Terephthalate (PET) Film, Sheet, and Strip from India: Request for Antidumping Duty Administrative Review,” dated August 1, 2016.

    3See Polyplex USA and Flex USA's Letter, “Request for Administrative Review,” dated July 29, 2016.

    4See Jindal Poly Films Ltd. (India)'s Letter, “Polyethylene Terephthalate (PET) Film from India: Requests for Administrative Review of the Antidumping Duty Order and Countervailing Duty Order,” dated July 29, 2016; see also SRF Limited of India's Letter, “Polyethylene Terephthalate (PET) Film from India/Request for Antidumping Admin Review/SRF Limited,” dated July 30, 2016; see also SRF's Letter, “Polyethylene Terephthalate (PET) Film from India/Withdrawal of Request for Antidumping Admin Review/SRF Limited,” dated December 9, 2016.

    5 These companies were Ester, Garware, Jindal Poly Films Limited of India, Jindal Poly Films Ltd. (India), MTZ, Polyplex Corporation, SRF, Uflex Ltd., Vacmet, and Vacmet India Limited. See Initiation of Antidumping and Countervailing Duty Administrative Reviews, 81 FR 62720, (September 12, 2016) (Initiation Notice).

    On November 2, 2016, the Department selected Jindal and SRF as mandatory respondents.6 On December 9, 2016, Jindal and SRF each separately withdrew their self-requests for review.7 On December 12, 2016, the petitioners withdrew their requests for Ester, Garware, Polyplex and Vacmet.8 Also on December 12, 2016, Polyplex USA and Flex USA withdrew their requests for SRF, Jindal, Garware, Ester, MTZ, Vacmet India Limited, Uflex Ltd., and Polyplex Corporation.9

    6See Memorandum, “Administrative Review of the Antidumping Duty Order on Polyethylene Terephthalate Film, Sheet, and Strip from India: Selection of Respondents for Individual Examination,” dated November 2, 2016.

    7See Jindal's Letter, “Polyethylene Terephthalate (PET) Film from India: Withdrawal of Requests for Administrative Review of the Antidumping Duty Order and Countervailing Duty Order,” dated December 9, 2016; see also SRF's Letter, “Polyethylene Terephthalate (PET) Film from India/Withdrawal of Request for Antidumping Admin Review/SRF Limited,” dated December 9, 2016.

    8See Petitioners' Letter, “Polyethylene Terephthalate (PET) Film, Sheet, and Strip from India: Withdrawal of Request for Antidumping Duty Administrative Review,” dated December 12, 2016.

    9See Polyplex's Letter, “Polyethylene Terephthalate (PET) Film, Sheet, and Strip from India: Request for Withdrawal of Administrative Review,” dated December 12, 2016.

    Partial Rescission of Administrative Review

    Pursuant to 19 CFR 351.213(d)(1), based on the timely withdrawal of the requests for review, we are rescinding this administrative review with respect to the following companies named in the Initiation Notice: Ester, Garware, MTZ, Polyplex Ltd., Uflex Ltd., Vacmet, and Vacmet India Limited.

    Methodology

    The Department is conducting this review in accordance with section 751(a)(2) of the Tariff Act of 1930, as amended (the Act). Export price is calculated in accordance with section 772 of the Act. NV is calculated in accordance with section 773 of the Act.

    For a full description of the methodology underlying our conclusions, see the Preliminary Decision Memorandum. A list of topics discussed in the Preliminary Decision Memorandum is attached as an Appendix to this notice.

    The Preliminary Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at https://access.trade.gov/login.aspx and it is available to all parties in the Central Records Unit, Room B8024 of the main Department of Commerce building. In addition, a complete version of the Preliminary Decision Memorandum can be accessed directly on the Internet at http://enforcement.trade.gov/frn/. The signed Preliminary Decision Memorandum and the electronic versions of the Preliminary Decision Memorandum are identical in content.

    Preliminary Results of Review

    As a result of this review, we preliminarily determine the following weighted-average dumping margins for the period July 1, 2015, through June 30, 2016.

    10 The Initiation Notice also lists the company as Jindal Poly Films Ltd. (India). As noted in Decision Memoranda, dated concurrently with this notice, the Department has determined that Jindal Poly Films Limited of India is the same company as Jindal Poly Films Ltd. (India).

    Manufacturer/exporter Weighted-average
  • dumping margins
  • (percent)
  • Jindal Poly Films Limited of India 10 2.34 SRF Limited 0.00
    Disclosure and Public Comment

    The Department will disclose to interested parties the calculations performed in connection with these preliminary results within five days of the date of publication of this notice.11 Pursuant to 19 CFR 351.309(c), interested parties may submit cases briefs no later than 30 days after the date of publication of this notice.12 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.13 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.14 Case and rebuttal briefs should be filed using the Department's electronic filing system, ACCESS.15 In order to be properly filed, ACCESS must successfully receive an electronically-filed document in its entirety by 5:00 p.m. Eastern Time.

    11See 19 CFR 351.224(b).

    12See 19 CFR 351.309(c)(ii).

    13See 19 CFR 351.309(d).

    14See 19 CFR 351.309(c)(2) and (d)(2).

    15See 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, filed electronically via ACCESS, within 30 days after the date of publication of this notice.16 Requests should contain: (1) The party's name, address, and telephone number; (2) the number of participants; and (3) a list of issues to be discussed. Issues raised in the hearing will be limited to those raised in the respective case 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 20230.17

    16See 19 CFR 351.310(c).

    17See 19 CFR 351.310(d).

    The Department will issue the results of this administrative review, including the results of its analysis of the issues raised in any written briefs, not later than 120 days after the date of publication of this notice in the Federal Register, pursuant to section 751(a)(3)(A) of the Act, unless that time is extended.

    Assessment Rates

    Upon completion of the administrative review, the Department shall determine, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries in accordance with 19 CFR 351.212(b)(1). We will instruct CBP to liquidate entries of merchandise produced and/or exported by respondent companies. We intend to issue instructions to CBP 15 days after the date of publication of the results of this review.

    For the individually examined respondents Jindal and SRF, if the weighted-average dumping margins are not zero or de minimis (i.e., less than 0.5 percent) in the final results of this review, we will calculate importer-specific (or customer-specific) ad valorem assessment rates on the basis of the ratio of the total amount of dumping calculated for the importer's examined sales and the total entered value of the sales in accordance with 19 CFR 351.212(b)(1). However, where the respondent did not report the entered value for its sales, we will calculate importer-specific (or customer-specific) per-unit duty assessment rates. Where a respondent's weighted-average dumping margin is zero or de minimis, or an importer-specific assessment rate is zero or de minimis, we will instruct CBP to liquidate the appropriate entries without regard to antidumping duties.

    Cash Deposit Requirements

    The following cash deposit requirements will be effective for all shipments of PET Film from India entered, or withdrawn from warehouse, for consumption on or after the date of publication of the final results of this administrative review, as provided for by section 751(a)(2)(C) of the Act: (1) The cash deposit rate for the company under review will be the rate established in the final results of this review (except, if the rate is zero or de minimis, i.e., less than 0.5 percent, no cash deposit will be required); (2) for previously reviewed or investigated companies not listed above, the cash deposit rate will continue to be the company-specific rate published for the most recent period; (3) if the exporter is not a firm covered in this review, a prior review, or the less-than-fair-value investigation, but the manufacturer is, the cash deposit rate will be the rate established for the most recent period for the manufacturer of the merchandise; and (4) if neither the exporter nor the manufacturer is a firm covered in this or any previous review, the cash deposit rate will be the all others rate for this proceeding, 5.71 percent. These deposit requirements, when imposed, shall remain in effect until further notice.

    Notification to Interested Parties

    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 and/or countervailing duties prior to liquidation of the relevant entries during this POR. Failure to comply with this requirement could result in the Secretary's presumption that reimbursement of antidumping duties and/or countervailing duties occurred and the subsequent assessment of doubled 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(h)(1) and 351.221(b)(4).

    Dated: July 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. Partial Rescission 4. Scope of the Order 5. Comparisons to Normal Value 6. Product Comparisons 7. Date of Sale 8. Export Price 9. Normal Value 10. Currency Conversion 11. Recommendation
    [FR Doc. 2017-16501 Filed 8-4-17; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-489-805] Certain Pasta From Turkey: Preliminary Results of Antidumping Duty Administrative Review 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 certain pasta (pasta) from Turkey. The review covers one exporter and producer of subject merchandise, Mutlu Makarnacilik Sanayi ve Ticaret A.S. (Mutlu). The period of review (POR) is July 1, 2015 through June 30, 2016. The Department preliminarily determines that Mutlu did not make a bona fide sale during the POR; therefore, we are preliminarily rescinding this administrative review. Interested parties are invited to comment on the preliminary results of this review.

    DATES:

    Applicable August 7, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Fred Baker, AD/CVD Operations, Office VI, Enforcement and Compliance, International Trade Administration, Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-2924.

    SUPPLEMENTARY INFORMATION:

    Background

    On July 24, 1996, the Department published the antidumping duty order on pasta from Turkey.1 On July 5, 2016, the Department published a notice of an opportunity for interested parties to request an administrative review of the antidumping duty order on pasta from Turkey.2 On July 29, 2016, the Department received a timely request for review of the order from Mutlu.3 Accordingly, on September 12, 2016, the Department published a notice of initiation of administrative review of the antidumping duty order on pasta from Turkey, covering the period July 1, 2015, through June 30, 2016.4 The Department subsequently issued initial and supplemental questionnaires to Mutlu, including an importer questionnaire to which we requested that Mutlu respond, if necessary, in collaboration with its importer.5 We received timely responses to these questionnaires. On April 3, 2017, and again on May 31, 2017, the Department extended the preliminary results of this review.6

    1See Notice of Antidumping Duty Order and Amended Final Determination of Sales at Less than Fair Value: Certain Pasta from Turkey, 61 FR 38545 (July 24, 1996).

    2See Antidumping or Countervailing Duty Order, Finding, or Suspended Investigation; Opportunity to Request Administrative Review, 81 FR 43584 (July 5, 2016).

    3See Letter from Mutlu, “Request for Administrative Review; Antidumping Duty Order Involving Certain Pasta from Turkey,” dated July 29, 2016.

    4See Initiation of Antidumping and Countervailing Duty Administrative Reviews, 81 FR 62720 (September 12, 2016) (Initiation Notice).

    5See Department Letter to Mutlu, dated June 19, 2017 (importer questionnaire).

    6See Memorandum, “Certain Pasta from Turkey: Extension of Deadline for Preliminary Results of Antidumping Duty Administrative Review,” dated April 3, 2017; see also Memorandum, “Certain Pasta from Turkey: Extension of Deadline for Preliminary Results of Antidumping Duty Administrative Review,” dated May 31, 2017 (extending the deadline until July 31, 2017).

    Scope of the Order

    Imports covered by this order are shipments of certain non-egg dry pasta in packages of five pounds four ounces or less, whether or not enriched or fortified or containing milk or other optional ingredients such as chopped vegetables, vegetable purees, milk, gluten, diastases, vitamins, coloring and flavorings, and up to two percent egg white.

    For a full description of the scope of the order, see the Preliminary Decision Memorandum, (Preliminary Decision Memorandum).7

    7See “Decision Memorandum for the Preliminary Results of the Antidumping Duty Administrative Review of Certain Pasta from Turkey,” dated July 31, 2017. A list of the topics discussed in the Preliminary Decision Memorandum appears in Appendix I of this notice.

    Methodology

    The Department is conducting this review in accordance with section 751(a)(1)(B) and (2) of the Tariff Act of 1930, as amended (the Act). For a full description of the methodology underlying our conclusions, see the Preliminary Decision Memorandum, which is hereby adopted by this notice. 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 is available 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 at http://enforcement.trade.gov/frn/. The signed Preliminary Decision Memorandum and the electronic version of the Preliminary Decision Memorandum are identical in content.

    Preliminary Rescission of the Antidumping Administrative Review of Mutlu

    As discussed in the Bona Fide Sales Analysis Memorandum,8 the Department preliminarily finds that the sale made by Mutlu serving as the basis for this review is not a bona fide sale. Limited information is on the record of this review, due to Mutlu's importer's failure to respond to the importer questionnaire. Nonetheless, the Department reached this conclusion based on the totality of the record information surrounding Mutlu's reported sales, including those sales prices and quantities and the limited number of sales (i.e., one sale) that Mutlu reported during the POR.

    8See Memorandum, “2015-2016 Antidumping Duty Administrative Review of Certain Pasta from Turkey: Preliminary Bona Fide Sales Analysis for Mutlu Makarnacilik Sanayi ve Ticaret A.S.,” (Bona Fide Sales Analysis Memorandum) dated concurrently with, and hereby adopted by, this notice.

    Because the non-bona fide sale was the only reported sale of subject merchandise during the POR, we find that Mutlu had no reviewable transactions during this POR. Accordingly, we are preliminarily rescinding this administrative review.9 Given that the factual information used in our bona fides analysis of Mutlu's sale involves business proprietary information, see the Bona Fide Sales Analysis Memorandum for a full discussion of the basis for our preliminary determination.

    9See 19 CFR 351.213(d)(3).

    Public Comment

    Interested parties may submit case briefs no later than 30 days after the date of publication of the preliminary results of review.10 Rebuttals to case briefs may be filed no later than five days after the briefs are filed.11 All rebuttal comments must be limited to comments raised in the case briefs.12

    10See 19 CFR 351.309(c).

    11See 19 CFR 351.309(d)(1).

    12See 19 CFR 351.309(d)(2).

    Interested parties who wish to request a hearing must submit a written request to the Assistant Secretary for Enforcement & Compliance, U.S. Department of Commerce, within 30 days after the date of publication of this notice.13 Requests should contain the party's name, address, and telephone number, the number of participants, and a list of the issues to be discussed. Oral argument presentations will be limited to issues raised in the 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.14 Parties should confirm by telephone the date, time, and location of the hearing two days before the scheduled date.

    13See 19 CFR 351.310(c).

    14See 19 CFR 351.310(d).

    All submissions, with limited exceptions, must be filed electronically using ACCESS. An electronically filed document must be received successfully in its entirety by the Department's electronic records system, ACCESS, by 5 p.m. Eastern Time (ET) on the due date. Documents excepted from the electronic submission requirements must be filed manually (i.e., in paper form) with the APO/Dockets Unit in Room 18022, and stamped with the date and time of receipt by 5 p.m. ET on the due date.15

    15See Antidumping and Countervailing Duty Proceedings: Electronic Filing Procedures; Administrative Protective Order Procedures, 76 FR 39263 (July 6, 2011).

    The Department intends to issue the final results of this administrative review, which will include the results of its analysis of issues raised in any briefs received, no later than 90 days after the date these preliminary results of review are issued, pursuant to section 751(a)(2)(B) of the Act.

    Assessment Rates

    If the Department proceeds to a final rescission of this administrative review, the assessment rate to which Mutlu's shipments will be subject will not be affected by this review. If the Department does not proceed to a final rescission of this administrative review, pursuant to 19 CFR 351.212(b)(1), we will calculate importer-specific (or customer-specific) assessment rates based on the final results of this review.

    Cash Deposit Requirements

    If the Department proceeds to a final rescission of this administrative review, Mutlu's cash deposit rate will continue to be the all-others rate. If the Department issues final results for this administrative review, the Department will instruct CBP to collect cash deposits, effective upon the publication of the final results, at the rates established therein.

    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)(2)(B) and 777(i)(1) of the Act.

    Dated: July 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 I

    List of Sections in the Preliminary Decision Memorandum 1. Summary 2. Background 3. Scope of the Order 4. Discussion of the Methodology 5. Conclusion [FR Doc. 2017-16577 Filed 8-4-17; 8:45 am] BILLING CODE 3510-DS-P DEPARTMENT OF COMMERCE International Trade Administration [A-523-808] Certain Steel Nails From the Sultanate of Oman: Preliminary Results of Antidumping Duty Administrative Review and Partial Rescission of Antidumping Duty Administrative Review; 2014-2016 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 (AD) order on certain steel nails (nails) from the Sultanate of Oman (Oman). The period of review (POR) is December 29, 2014, through June 30, 2016. This administrative review covers two exporters of the subject merchandise, both of which were selected as mandatory respondents, Oman Fasteners LLC (Oman Fasteners) and Overseas International Steel Industry LLC (OISI). The Department preliminarily determines Oman Fasteners and OISI made sales of subject merchandise at less than normal value during the POR. Additionally, we are rescinding this administrative review, in part, with respect to 12 companies, based on the timely withdrawal of Mid Continent Steel & Wire, Inc.'s (the petitioner) request for administrative review. Interested parties are invited to comment on these preliminary results.

    DATES:

    Applicable August 7, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Lilit Astvatsatrian or Thomas Martin, AD/CVD Operations, Office IV, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-6412 or (202) 482-3936, respectively.

    SUPPLEMENTARY INFORMATION:

    On July 13, 2015, the Department published in the Federal Register an AD order on nails from Oman.1 On July 5, 2016, the Department notified interested parties of the opportunity to request an administrative review of orders, findings, or suspended investigations with anniversaries in July 2016, including the AD order on nails from Oman. The Department received timely requests from Oman Fasteners, OISI, and the petitioner to conduct an administrative review of certain exporters covering the POR. On September 12, 2016, the Department published a notice initiating an AD administrative review of nails from Oman covering 15 companies for the POR.2

    1See Certain Steel Nails from the Republic of Korea, Malaysia, the Sultanate of Oman, Taiwan, and the Socialist Republic of Vietnam: Antidumping Duty Orders, 80 FR 39994 (July 13, 2015) (Order).

    2See Initiation of Antidumping and Countervailing Duty Administrative Reviews, 81 FR 62720 (September 12, 2016) (Initiation Notice).

    In the Initiation Notice, the Department indicated that, in the event that we would limit the respondents selected for individual examination in accordance with section 777A(c)(2) of the Tariff Act of 1930, as amended (the Act), we would select mandatory respondents for individual examination based upon U.S. Customs and Border Protection (CBP) entry data.3 On November 9, 2016, after considering the large number of potential producers/exporters involved in this administrative review, and the resources available to the Department, we determined that it was not practicable to examine all exporters/producers of subject merchandise for which a review was requested.4 As a result, pursuant to section 777A(c)(2)(B) of the Act, we determined that we could reasonably individually examine only the two largest producers/exporters of nails from Oman by U.S. entry volume during the POR (i.e., Oman Fasteners and OISI).5 Accordingly, we issued the AD questionnaire to these companies, Oman Fasteners and OISI, the two mandatory respondents.6 On December 12, 2016, the petitioner timely withdrew its request for administrative review, pursuant to 19 CFR 351.213(d)(1), of all the producers and exporters except for Oman Fasteners, OISI, and Overseas Distribution Services Inc. (ODS).7

    3See Initiation Notice, 81 FR at 62720.

    4See Memorandum entitled, “Respondent Selection in the first Antidumping Duty Administrative Review of Certain Steel Nails from Oman,” dated November 9, 2016 (Respondent Selection Memorandum).

    5See Respondent Selection Memorandum.

    6See Department Letter, “Administrative Review of Certain Steel Nails from Oman: Antidumping Duty Questionnaire,” dated November 9, 2016.

    7See Letter from the petitioner, “Certain Steel Nails from Oman: Withdrawal of Request for Administrative Review, dated December 12, 2016.

    On March 23, 2017, the Department extended the preliminary results in this review to no later than July 31, 2017.8

    8See Memorandum, “Certain Steel Nails from the Sultanate of Oman: Extension of Deadline for Preliminary Results of Antidumping Duty Administrative Review,” dated March 23, 2017.

    Partial Rescission of Administrative Review

    The Department received timely requests to conduct an administrative review of certain exporters covering the POR. Because the petitioner timely withdrew its requests for review of all of the companies listed in the Initiation Notice, with the exception of Oman Fasteners, OISI, and ODS, we are rescinding the administrative review with respect to those 12 companies, pursuant to 19 351.213(d)(1). The Department has rescinded the administrative review with respect to the remaining 12 companies on which we initiated this review pursuant to 19 CFR 351.213(d)(1).9 Accordingly, the remaining companies subject to the instant review are: Oman Fasteners, OISI, and ODS.

    9 Astrotech Steels Private Ltd, Consolidated Shipping services LLC, Damco India Private Ltd., Flyjac Logistics Private Ltd., International Maritime & Aviation LLC, Liladhar Pasoo India Logistics Private Ltd., Ivk Manuport Logistics LLC, Raajratna Metal Industries Ltd., Shanxi Tianli Industries Co. Ltd., Swift Freight India Private Ltd., United Building Material Factory, Uniworld Logistics Pvt Ltd.

    Scope of the Order

    The merchandise covered by this order is nails having a nominal shaft length not exceeding 12 inches.10 Merchandise covered by the order is currently classified under the Harmonized Tariff Schedule of the United States (HTSUS) subheadings 7317.00.55.02, 7317.00.55.03, 7317.00.55.05, 7317.00.55.07, 7317.00.55.08, 7317.00.55.11, 7317.00.55.18, 7317.00.55.19, 7317.00.55.20, 7317.00.55.30, 7317.00.55.40, 7317.00.55.50, 7317.00.55.60, 7317.00.55.70, 7317.00.55.80, 7317.00.55.90, 7317.00.65.30, 7317.00.65.60 and 7317.00.75.00. Nails subject to this order also may be classified under HTSUS subheadings 7907.00.60.00, 8206.00.00.00 or other HTSUS subheadings. While the HTSUS subheadings are provided for convenience and customs purposes, the written description of the scope of this order is dispositive. For a complete description of the scope of the order, see the Preliminary Decision Memorandum.11

    10 The shaft length of certain steel nails with flat heads or parallel shoulders under the head shall be measured from under the head or shoulder to the tip of the point. The shaft length of all other certain steel nails shall be measured overall.

    11See Memorandum, “Decision Memorandum for Preliminary Results of the 2014-2016 Antidumping Duty Administrative Review of Certain Steel Nails from the Sultanate of Oman,” dated concurrently with, and hereby adopted by this notice (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 available to all parties in the Central Records Unit, room B8024 of the main Department of Commerce building. In addition, a complete version of the Preliminary Decision Memorandum can be accessed directly on the Internet at http://enforcement.trade.gov/frn/. The signed and electronic versions of the Preliminary Decision Memorandum are identical in content.

    Methodology

    The Department is conducting this review in accordance with section 751(a) of the Tariff Act of 1930, as amended (the Act). Export price and constructed export price are calculated in accordance with section 772 of the Act. Normal value is calculated in accordance with section 773 of the Act.

    For a full description of the methodology underlying our conclusions, see the Preliminary Decision Memorandum.12 A list of topics included in the Preliminary Decision Memorandum is included as an Appendix to this notice.

    12See Preliminary Decision Memorandum.

    Adverse Facts Available

    Section 776(a) of the Act provides that the Department shall, subject to section 782(d) of the Act, use “facts otherwise available” if: (1) Necessary information is not on the record; or (2) an interested party or any other person: (A) Withholds information that has been requested; (B) fails to provide information within the deadlines established, or in the form and manner requested by the Department, subject to subsections (c)(1) and (e) of section 782 of the Act; (C) significantly impedes a proceeding; or (D) provides information that cannot be verified as provided by section 782(i) of the Act.

    Section 776(b) of the Act provides that the Department may use an adverse inference in applying the facts otherwise available when a party fails to cooperate by not acting to the best of its ability to comply with a request for information (i.e., adverse facts available, or AFA). In doing so, and under the Trade Preferences Extension Act of 2015 (TPEA), the Department is not required to determine, or make any adjustments to, a weighted-average dumping margin based on any assumptions about information an interested party would have provided if the interested party had complied with the request for information. Further, section 776(b)(2) of the Act states that an adverse inference may include reliance on information derived from the petition, the final determination from the less than fair value investigation, a previous administrative review, or other information placed on the record.

    Section 776(c) of the Act provides that, in general, when the Department relies on secondary information rather than on information obtained in the course of an investigation, it shall, to the extent practicable, corroborate that information from independent sources that are reasonably at its disposal. Secondary information is defined as information derived from the petition that gave rise to the investigation, the final determination concerning the subject merchandise, or any previous review under section 751 of the Act concerning the subject merchandise. However, the Department is not required to corroborate any dumping margin applied in a separate segment of the same proceeding.

    Under section 776(d) of the Act, the Department may use any dumping margin from any segment of a proceeding under an AD order when applying an adverse inference, including the highest of such margins. The TPEA also makes clear that when selecting an AFA margin, the Department is not required to estimate what the dumping margin would have been if the interested party failing to cooperate had cooperated or to demonstrate that the dumping margin reflects an “alleged commercial reality” of the interested party.

    In accordance with section 776 of the Act, the Department preliminarily determines that the application of facts available is warranted for OISI because OISI has not provided the necessary information on the record, pursuant to section 776(a)(1) of the Act. Specifically, OISI reported that ODS was its affiliate in the United Arab Emirates, but failed to provide adequate information regarding its relationship with ODS. OISI also failed to provide adequate information regarding its U.S. sales data, such that the Department could not use the data in its calculations. Furthermore, OISI has withheld requested information, failed to provide such information in the form and manner required, impeded this review, and reported information that could not be verified, the use of facts available for the preliminary results is warranted, pursuant to sections 776(a)(2)(A), (B), (C), and (D) of the Act. For a full discussion, see the Preliminary Decision Memorandum.

    Furthermore, by withholding requested information, failing to provide such information in the manner and form required, impeding this review, and reporting information that could not be verified, OISI failed to cooperate with the Department by not acting to the best of its ability to comply with a request for information by the Department, pursuant to section 776(b)(1) of the Act. Accordingly, we preliminarily determine to apply adverse facts available (AFA) to OISI, in accordance with sections 776(a) and (b) of the Act and 19 CFR 351.308. Record information indicates that OISI and ODS are affiliated and may meet our criteria for collapsing, due to OISI's reported shared ownership and intertwined operations with ODS. Because OISI did not answer our supplemental questionnaire, we do not have all of the information we need on the record in order to conduct a collapsing analysis. Accordingly, we have applied an adverse inference to the factual information on the record, and have, as AFA, collapsed OISI and ODS into a single entity. Furthermore, as we do not have adequate information on the record to calculate a margin for OISI, we have calculated its margin based on total AFA. Specifically, we are applying a rate of 154.33 percent, which was calculated by Petitioner in the petition in this investigation.13 We have corroborated this rate with information obtained in the course of this administrative review, consistent with section 776(c)(1) of the Act. For further discussion, see the Preliminary Decision Memorandum.

    13 Letter from the Department, “Certain Steel Nails India, the Republic of Korea, the Sultanate of Oman, Malaysia, Taiwan, the Republic of Turkey, and the Socialist Republic of Vietnam,” dated May 29, 2014 (Petition). See also section 776(b)(2)(A) (stating that the petition is a potential source of information for the application of adverse facts available).

    Preliminary Results of Review

    As a result of this review, we preliminarily determine the following weighted-average dumping margins for the period December 29, 2014 through June 30, 2016:

    Exporter/producer Weighted-
  • average dumping
  • margins
  • (percent)
  • Oman Fasteners LLC 99.88 Overseas International Steel Industry LLC/Overseas Distribution Services Inc14 154.33
    Assessment Rates

    14 ODS was initially a non-selected respondent subject to this administrative review; however, because we have, as AFA, collapsed ODS with mandatory respondent OISI, we are assigning both the same AFA margin.

    Upon completion of the administrative review, the Department shall determine, and CBP shall assess, antidumping duties on all appropriate entries. The Department intends to issue assessment instructions to CBP 15 days after the date of publication of the final results of this review.

    For any individually examined respondents whose weighted-average dumping margin is above de minimis (i.e., 0.50 percent), we will calculate importer-specific ad valorem duty assessment rates based on the ratio of the total amount of dumping calculated for the importer's examined sales to the total entered value of those same sales in accordance with 19 CFR 351.212(b)(1).15 For entries of subject merchandise during the POR produced by each respondent for which it did not know its merchandise was destined for the United States, we will instruct CBP to liquidate un-reviewed entries at the all-others rate if there is no rate for the intermediate company involved in the transaction.16 We will instruct CBP to assess antidumping duties on all appropriate entries covered by this review when the importer-specific assessment rate calculated in the final results of this review is above de minimis. Where either the respondent's weighted-average dumping margin is zero or de minimis, or an importer-specific assessment rate is zero or de minimis, we will instruct CBP to liquidate the appropriate entries without regard to antidumping duties.

    15 In these preliminary results, the Department applied the assessment rate calculation methodology adopted in Antidumping Proceedings: Calculation of the Weighted-Average Dumping Margin and Assessment Rate in Certain Antidumping Proceedings: Final Modification, 77 FR 8101 (February 14, 2012).

    16See Antidumping and Countervailing Duty Proceedings: Assessment of Antidumping Duties, 68 FR 23954 (May 6, 2003).

    For the twelve companies for which this review is rescinded, antidumping duties will be assessed at rates equal to the cash deposit of estimated antidumping duties required at the time of entry, or withdrawn from warehouse, for consumption, in accordance with 19 CFR 351.212(c)(1)(i). The Department intends to issue appropriate assessment instructions directly to CBP 15 days after publication of this notice. The final results of this review shall be the basis for the assessment of antidumping duties on entries of merchandise covered by the final results of this review and for future deposits of estimated duties, where applicable.

    Cash Deposit Requirement

    The following deposit requirements will be effective upon publication of the notice of the final results of administrative review for all shipments of nails from Oman entered, or withdrawn from warehouse, for consumption on or after the date of publication of the final results of this administrative review, as provided by section 751(a)(2)(C) of the Act: (1) The cash deposit rate for the companies under review will be the rate established in the final results of this review (except, if the rate is zero or de minimis, no cash deposit will be required); (2) for merchandise exported by manufacturers or exporters not covered in this review but covered in a prior segment of the proceeding, the cash deposit rate will continue to be the company-specific rate published for the most recently completed segment of this proceeding in which the manufacturer or exporter participated; (3) if the exporter is not a firm covered in this review, a prior review, or the less-than-fair-value investigation, but the manufacturer is, the cash deposit rate will be the rate established for the most recently completed segment of the proceeding for the manufacturer of the merchandise; and (4) the cash deposit rate for all other manufacturers or exporters will continue to be 9.10 percent ad valorem, the all-others rate established in the less-than-fair value investigation.17

    17See Certain Steel Nails from the Republic of Oman: Final Determination of Sales at Less Than Fair Value, 80 FR 28955 (May 20, 2015).

    Disclosure and Public Comment

    The Department intends to disclose the calculations used in our analysis to interested parties in this review within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b). Interested parties are invited to comment on the preliminary results of this review. Pursuant to 19 CFR 351.309(c)(1)(ii), interested parties may submit case briefs no later than 30 days after the date of publication of this notice. Rebuttal briefs, limited to issues raised in the case briefs, may be filed no later than five days after the time limit for filing case briefs.18 Parties who submit case briefs or rebuttal briefs in this proceeding are requested to submit with each brief: (1) A statement of the issue, (2) a brief summary of the argument, and (3) a table of authorities.19 Executive summaries should be limited to five pages total, including footnotes.20 Case and rebuttal briefs should be filed using ACCESS.21

    18See 19 CFR 351.309(d)(1).

    19See 19 CFR 351.309(c)(2) and (d)(2).

    20Id.

    21See 19 CFR 351.303.

    Pursuant to 19 CFR 351.310(c), any interested party may request a hearing within 30 days of the publication of this notice in the Federal Register. If a hearing is requested, the Department will notify interested parties of the hearing schedule. Interested parties who wish to request a hearing, or to participate if one is requested, must submit a written request to the Assistant Secretary for Enforcement and Compliance, filed electronically via ACCESS within 30 days after the date of publication of this notice. Requests should contain: (1) The party's name, address, and telephone number; (2) the number of participants; and (3) a list of the issues to be discussed. Issues raised in the hearing will be limited to those raised in the respective case and rebuttal briefs.

    We intend to issue the final results of this administrative review, including the results of our analysis of issues raised by the parties in the written comments, within 120 days of publication of these preliminary results in the Federal Register, unless otherwise extended.22

    22See section 751(a)(3)(A) of the Act.

    Notification to Importers

    This notice also serves as a preliminary reminder to importers of their responsibility under 19 CFR 351.402(f) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the Department's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.

    These preliminary results and partial rescission of administrative review are issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Act and 19 CFR 351.213(h)(1).

    Dated: July 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 I. Summary II. Background III. Scope of the Order IV. Affiliation V. Use of Facts Otherwise Available and Adverse Interferences VI. Discussion of the Methodology VII. Recommendation
    [FR Doc. 2017-16497 Filed 8-4-17; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-557-816] Certain Steel Nails From Malaysia: Preliminary Results and Partial Rescission of Antidumping Duty Administrative Review; 2014-2016 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 certain steel nails from Malaysia. The period of review covers December 29, 2014, through June 30, 2016. The review covers three producers/exporters of the subject merchandise. We preliminarily determine that sales of subject merchandise by the collapsed entities Inmax and Region, both of which were selected for individual examination, were made at less than normal value during the period of review. We are rescinding the review with respect to 16 companies for which the request for review was timely withdrawn. Interested parties are invited to comment on these preliminary results.

    DATES:

    Applicable August 7, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Edythe Artman or Madeline Heeren, 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) 482-3931 or (202) 482-9179, respectively.

    SUPPLEMENTARY INFORMATION: Background

    These preliminary results of review are made in accordance with section 751 of the Tariff Act of 1930, as amended (the Act). On September 12, 2016, the Department published the notice of initiation for the administrative review.1 For a complete description of the events that followed the initiation of the review, see the Preliminary Decision Memorandum.2 A list of topics included in the Preliminary Decision Memorandum is included as Appendix II to this notice. The Preliminary Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at https://access.trade.gov and to all parties in the Central Records Unit, located in Room B8094 of the main Department of Commerce building. In addition, a complete version of the Preliminary Decision Memorandum can be accessed directly at http://enforcement.trade.gov/frn/. The signed and the electronic versions of the Preliminary Decision Memorandum are identical in content.

    1See Initiation of Antidumping and Countervailing Duty Administrative Reviews, 81 FR 62720 (September 12, 2016) (Initiation Notice).

    2See Memorandum, “Decision Memorandum for Preliminary Results of Antidumping Duty Administrative Review and Intent to Rescind in Part: Certain Steel Nails from Malaysia; 2014-2016”, dated concurrently with this notice.

    Scope of the Order

    The products covered by the scope of the order are certain steel nails from Malaysia. For a complete description of the scope, see Appendix I of this notice.

    Partial Rescission of Administrative Review

    In the Initiation Notice, we initiated a review of 19 companies. However, the petitioner, Mid Continent Steel & Wire, Inc., withdrew its request for review of 16 of the companies on December 12, 2016. No other parties had requested a review of these companies. Thus, in response to the petitioner's timely filed withdrawal request and pursuant to 19 CFR 351.213(d)(1), we are rescinding this administrative review for the following companies: Apex Container Line (M) Sdn Bhd; Astrotech Steels Private Ltd.; C.H. Robinson Freight Services Ltd.; Caribbean International Co. Ltd.; Chia Pao Metal Co. Ltd.; Expeditors (Malaysia) Sdn Bhd; Flyjac Logistics Private Ltd.; Hanjin Logistics India Private Ltd.; Hecny Transportation (M) Sdn Bhd; Honour Lane Logistics Sdn Bhd; Jinhai Hardware Co. Ltd.; Nora Freight Services Sdn Bhd; Orient Containers Sdn Bhd; Orient Star Transport Sdn Bhd; Sino Connections Logistics Co. Ltd.; and Swift Freight Private Ltd.

    Methodology

    The Department is conducting this review in accordance with section 751(a)(1)(B) of the Act. For a full description of the methodology underlying the preliminary results, see the Preliminary Decision Memorandum.

    Preliminary Results of Review

    We preliminarily determine that, for the period December 29, 2014, through June 30, 2016, the following weighted-average dumping margins exist: 34

    3 The Department has preliminarily determined to collapse, and treat as a single entity, affiliates Inmax Sdn. Bhd. and Inmax Industries Sdn. Bhd. (collectively, Inmax) and Region International Co. Ltd. and Region System Sdn. Bhd. (collectively Region). For our analysis of the collapsing criteria, see the company-specific analysis memorandum, dated concurrently with this notice.

    4 As we did not have a publicly-ranged total U.S. sales value for Region for the period December 29, 2014, through June 30, 2016, to calculate a weighted-average dumping margin for the non-examined company, Tag Fasteners, the rate applied to this company is a simple average of the weighted-average dumping margins calculated for Inmax and Region.

    Producer or exporter Weighted-
  • average
  • dumping
  • margin
  • (percent)
  • Inmax Sdn. Bhd. and Inmax Industries Sdn. Bhd 1.03 Region International Co. Ltd. and Region System Sdn. Bhd 2.56 Tag Fasteners Sdn. Bhd 1.80
    Disclosure and Public Comment

    The Department will disclose to parties to the proceeding any calculations performed in connection with these preliminary results of review within five days after the date of publication of this notice.5 Interested parties may submit case briefs not later than 30 days after the date of publication of this notice in the Federal Register.6 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.7 Parties who submit case 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.8 Case and rebuttal briefs should be filed using ACCESS.9

    5See 19 CFR 351.224(b).

    6See 19 CFR 351.309(c)(1)(ii).

    7See 19 CFR 351.309(d)(1).

    8See 19 CFR 351.309(c)(2) and (d)(2).

    9See 19 CFR 351.303.

    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.10 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.11 Parties should confirm by telephone the date, time, and location of the hearing two days before the scheduled date.

    10See 19 CFR 351.310(c).

    11See 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

    Upon issuance of the final results, the Department will determine, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries covered by this review.12 If a respondent's weighted-average dumping margin is not zero or de minimis in the final results of this review and the respondent reported reliable entered values, we will calculate importer-specific ad valorem assessment rates for the merchandise based on the ratio of the total amount of dumping calculated for the examined sales made during the period of review to each importer to the total entered value of those same sales in accordance with 19 CFR 351.212(b)(1). If the respondent has not reported reliable entered values, we will calculate a per-unit assessment rate for each importer by dividing the total amount of dumping for the examined sales made during the period of review to that importer by the total sales quantity associated with those transactions. Where an importer-specific ad valorem assessment rate is zero or de minimis, we will instruct CBP to liquidate the appropriate entries without regard to antidumping duties in accordance with 19 CFR 351.106(c)(2). If the respondent's weighted-average dumping margin is zero or de minimis in the final results of review, we will instruct CBP not to assess duties on any of its entries in accordance with the Final Modification for Reviews, i.e., “{w}here the weighted-average margin of dumping for the exporter is determined to be zero or de minimis, no antidumping duties will be assessed.” 13

    12See 19 CFR 351.212(b)(1).

    13See Antidumping Proceedings: Calculation of the Weighted-Average Dumping Margin and Assessment Rate in Certain Antidumping Proceedings: Final Modification, 77 FR 8101, 8102 (February 14, 2012) (Final Modification for Reviews).

    Regarding entries of subject merchandise during the period of review that were produced by Inmax and Region and for which they did not know that the merchandise was destined for the United States, we will instruct CBP to liquidate un-reviewed entries at the all-others rate of 2.66 percent, as established in the less-than-fair-value investigation of the order, if there is no rate for the intermediate company(ies) involved in the transaction.14 For a full discussion of this matter, see Assessment Policy Notice. 15

    14See Certain Steel Nails from the Republic of Korea, Malaysia, the Sultanate of Oman, Taiwan, and the Socialist Republic of Vietnam: Antidumping Duty Orders, 80 FR 39994 (July 13, 2015).

    15See Antidumping and Countervailing Duty Proceedings: Assessment of Antidumping Duties, 68 FR 23954 (May 6, 2003) (Assessment Policy Notice).

    For the firms covered by this review, we intend to issue liquidation instructions to CBP 15 days after publication of the final results of this review. For the non-reviewed firms for which we are rescinding this administrative review, the Department intends to instruct CBP 15 days after publication of these preliminary results of review to assess antidumping duties at rates equal to the rates of cash deposits for estimated antidumping duties required at the time of entry, or withdrawn from warehouse, for consumption, during the period December 29, 2014, through June 30, 2016, in accordance with 19 CFR 351.212(c)(2).

    Cash Deposit Requirements

    The following cash deposit requirements will be effective upon publication of the final results of this administrative review for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date 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 Inmax and Region and other companies listed above will be equal to the weighted-average dumping margin established in the final results of this administrative review; (2) for previously reviewed or investigated companies not listed above, the cash deposit rate will continue to be the company-specific rate published for the most recently completed segment of this proceeding in which they were reviewed; (3) if the exporter is not a firm covered in this review, a prior review, or in the investigation but the producer is, the cash deposit rate will be the rate established for the most recently completed segment of this proceeding for the producer of the merchandise; and (4) the cash deposit rate for all other producers or exporters will continue to be the all-others rate of 2.66 percent. These cash deposit requirements, when imposed, shall remain in effect until further notice.

    Notification to Importers

    This notice also serves as a 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.

    Notification to Interested Parties

    We are issuing and publishing this notice in accordance with sections 751(a)(1) and 777(i)(1) of the Act and 19 CFR 351.221(b)(4).

    Dated: July 28, 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 Scope of the Order

    The merchandise covered by the antidumping duty order is certain steel nails having a nominal shaft length not exceeding 12 inches.16 Certain steel nails include, but are not limited to, nails made from round wire and nails that are cut from flat-rolled steel. Certain steel nails may be of one piece construction or constructed of two or more pieces. Certain steel nails may be produced from any type of steel, and may have any type of surface finish, head type, shank, point type and shaft diameter. Finishes include, but are not limited to, coating in vinyl, zinc (galvanized, including but not limited to electroplating or hot dipping one or more times), phosphate, cement, and paint. Certain steel nails may have one or more surface finishes. Head styles include, but are not limited to, flat, projection, cupped, oval, brad, headless, double, countersunk, and sinker. Shank styles include, but are not limited to, smooth, barbed, screw threaded, ring shank and fluted. Screw-threaded nails subject to this proceeding are driven using direct force and not by turning the nail using a tool that engages with the head. Point styles include, but are not limited to, diamond, needle, chisel and blunt or no point. Certain steel nails may be sold in bulk, or they may be collated in any manner using any material.

    16 The shaft length of certain steel nails with flat heads or parallel shoulders under the head shall be measured from under the head or shoulder to the tip of the point. The shaft length of all other certain steel nails shall be measured overall.

    Excluded from the scope of this order are certain steel nails packaged in combination with one or more non-subject articles, if the total number of nails of all types, in aggregate regardless of size, is less than 25. If packaged in combination with one or more non-subject articles, certain steel nails remain subject merchandise if the total number of nails of all types, in aggregate regardless of size, is equal to or greater than 25, unless otherwise excluded based on the other exclusions below.

    Also excluded from the scope are certain steel nails with a nominal shaft length of one inch or less that are (a) a component of an unassembled article, (b) the total number of nails is sixty (60) or less, and (c) the imported unassembled article falls into one of the following eight groupings: (1) Builders' joinery and carpentry of wood that are classifiable as windows, French-windows and their frames; (2) builders' joinery and carpentry of wood that are classifiable as doors and their frames and thresholds; (3) swivel seats with variable height adjustment; (4) seats that are convertible into beds (with the exception of those classifiable as garden seats or camping equipment); (5) seats of cane, osier, bamboo or similar materials; (6) other seats with wooden frames (with the exception of seats of a kind used for aircraft or motor vehicles); (7) furniture (other than seats) of wood (with the exception of (i) medical, surgical, dental or veterinary furniture; and (ii) barbers' chairs and similar chairs, having rotating as well as both reclining and elevating movements); or (8) furniture (other than seats) of materials other than wood, metal, or plastics (e.g., furniture of cane, osier, bamboo or similar materials). The aforementioned imported unassembled articles are currently classified under the following Harmonized Tariff Schedule of the United States (HTSUS) subheadings: 4418.10, 4418.20, 9401.30, 9401.40, 9401.51, 9401.59, 9401.61, 9401.69, 9403.30, 9403.40, 9403.50, 9403.60, 9403.81 or 9403.89.

    Also excluded from the scope of this order are steel nails that meet the specifications of Type I, Style 20 nails as identified in Tables 29 through 33 of ASTM Standard F1667 (2013 revision).

    Also excluded from the scope of this order are nails suitable for use in powder-actuated hand tools, whether or not threaded, which are currently classified under HTSUS subheadings 7317.00.20.00 and 7317.00.30.00.

    Also excluded from the scope of this order are nails having a case hardness greater than or equal to 50 on the Rockwell Hardness C scale (HRC), a carbon content greater than or equal to 0.5 percent, a round head, a secondary reduced-diameter raised head section, a centered shank, and a smooth symmetrical point, suitable for use in gas-actuated hand tools.

    Also excluded from the scope of this order are corrugated nails. A corrugated nail is made up of a small strip of corrugated steel with sharp points on one side.

    Also excluded from the scope of this order are thumb tacks, which are currently classified under HTSUS subheading 7317.00.10.00.

    Certain steel nails subject to this order are currently classified under HTSUS subheadings 7317.00.55.02, 7317.00.55.03, 7317.00.55.05, 7317.00.55.07, 7317.00.55.08, 7317.00.55.11, 7317.00.55.18, 7317.00.55.19, 7317.00.55.20, 7317.00.55.30, 7317.00.55.40, 7317.00.55.50, 7317.00.55.60, 7317.00.55.70, 7317.00.55.80, 7317.00.55.90, 7317.00.65.30, 7317.00.65.60 and 7317.00.75.00. Certain steel nails subject to this order also may be classified under HTSUS subheadings 7907.00.60.00, 7806.00.80.00, 7318.29.00.00, 8206.00.00.00 or other HTSUS subheadings.

    While the HTSUS subheadings are provided for convenience and customs purposes, the written description of the scope of this order is dispositive.

    Appendix II List of Topics Discussed in the Preliminary Decision Memorandum 1. Background 2. Scope of the Order 3. Partial Rescission of Administrative Review 4. Company Not Selected for Individual Examination 5. Collapsing of Affiliated Companies 6. Date of Sale 7. Comparisons to Normal Value A. Determination of Comparison Method B. Results of the Differential Pricing Analysis 8. Product Comparisons 9. Export Price 10. Normal Value A. Home Market Viability as Comparison Market B. Level of Trade C. Sales to Affiliates D. Cost of Production 1. Calculation of Cost of Production 2. Test of Comparison Market Sales Prices 3. Results of the Cost of Production Test E. Calculation of Normal Value Based on Comparison Market Prices F. Price-to-Constructed Value Comparison 11. Currency Conversion 12. Recommendation
    [FR Doc. 2017-16496 Filed 8-4-17; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-583-854] Certain Steel Nails From Taiwan: Preliminary Results of Antidumping Duty Administrative Review and Partial Rescission of Administrative Review; 2015-2016 AGENCY:

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

    SUMMARY:

    The Department of Commerce (the Department) is conducting an administrative review of the antidumping duty order on certain steel nails from Taiwan. The period of review (POR) is May 20, 2015, through June 30, 2016. This review covers Bonuts Logistics Co., LLC (Bonuts); Hor Liang Industrial Corp.; Romp Coil Nails Industries Inc.; PT Enterprise, Inc. (PT Enterprise) and its affiliated producer Pro-Team Coil Nail Enterprise, Inc. (Pro-Team) (collectively, PT); and Unicatch Industrial Co. Ltd. and its affiliated U.S. reseller, TC International, Inc. (collectively, Unicatch). The Department preliminarily determines that Bonuts, Hor Liang Industrial Corp., Romp Coil Nails Industries Inc., PT, and Unicatch made U.S. sales of subject merchandise below normal value. The preliminary results are listed below in the section titled “Preliminary Results of Review.” We are rescinding the review with respect to 79 companies for which the request for review was timely withdrawn. Interested parties are invited to comment on these preliminary results.

    DATES:

    Applicable August 7, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Scott Hoefke or Victoria Cho, 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) 482-4947 or (202) 482-5075, respectively.

    SUPPLEMENTARY INFORMATION:

    Scope of the Order 1

    1See Certain Steel Nails from the Republic of Korea, Malaysia, the Sultanate of Oman, Taiwan, and the Socialist Republic of Vietnam: Antidumping Duty Orders, 80 FR 39994 (July 13, 2015) (the Order).

    The merchandise covered by this order is certain steel nails. The certain steel nails subject to the order are currently classifiable under HTSUS subheadings 7317.00.55.02, 7317.00.55.03, 7317.00.55.05, 7317.00.55.07, 7317.00.55.08, 7317.00.55.11, 7317.00.55.18, 7317.00.55.19, 7317.00.55.20, 7317.00.55.30, 7317.00.55.40, 7317.00.55.50, 7317.00.55.60, 7317.00.55.70, 7317.00.55.80, 7317.00.55.90, 7317.00.65.30, 7317.00.65.60 and 7317.00.75.00. Certain steel nails subject to these orders also may be classified under HTSUS subheadings 7907.00.60.00, 8206.00.00.00 or other HTSUS subheadings.

    The full description of the scope of the order is contained in the memorandum, “Decision Memorandum for Preliminary Results of Antidumping Duty Administrative Review: Certain Steel Nails from Taiwan; 2015-2016” (Preliminary Decision Memorandum), which is hereby adopted by this notice. The written description of the scope of the order is dispositive.

    Methodology

    For Unicatch, the Department has conducted this review in accordance with section 751(a)(1) of the Tariff Act of 1930, as amended (the Act). Normal value (NV) is calculated in accordance with section 773(e) of the Act. Constructed export price or export price is calculated in accordance with section 773(a) of the Act.

    For a full description of the methodology underlying our conclusions, see the Preliminary Decision Memorandum. The Preliminary Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at http://access.trade.gov and is available to all parties in the Central Records Unit, room B-8024 of the main Department of Commerce building. In addition, a complete version of the Preliminary Decision Memorandum can be accessed directly at http://enforcement.trade.gov/frn/index.html. The signed Preliminary Decision Memorandum and the electronic version of the Preliminary Decision Memorandum are identical in content. A list of the topics discussed in the Preliminary Decision Memorandum is attached as the Appendix to this notice.

    Application of Facts Available and Adverse Facts Available

    We preliminarily determine that PT and Bonuts failed to cooperate to the best of their ability in participating in the review, warranting the application of facts otherwise available with adverse inferences, pursuant to section 776(a)-(b) of the Act. For a full description of the methodology and rationale underlying our conclusions, see the Preliminary Decision Memorandum.

    Rate for Non-Examined Companies

    The statute and the Department's regulations do not address the establishment of a rate to be applied to companies not selected for examination when the Department limits its examination in an administrative review pursuant to section 777A(c)(2) 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 a market economy investigation, for guidance when calculating the rate for companies which were not selected for individual review in an administrative review. Under section 735(c)(5)(A) of the Act, the all-others rate is normally “an amount equal to the weighted average of the estimated weighted average dumping margins established for exporters and producers individually investigated, excluding any zero or de minimis margins, and any margins determined entirely {on the basis of facts available}.” In this review, we calculated a weighted-average dumping margin for Unicatch that is not zero, de minimis, or determined entirely on the basis of facts available. Accordingly, the Department assigned Hor Liang Industrial Corp., and Romp Coil Nails Industries Inc. a margin of 34.20 percent, which is Unicatch's calculated weighted-average dumping margin.

    Partial Rescission of Review

    On December 12, 2016, Mid Continent Steel & Wire, Inc. (Mid Continent), a domestic producer and interested party, timely withdrew its review requests for certain companies.2 Pursuant to 19 CFR 351.213(d)(1), the Department will rescind an administrative review, in whole or in part, if the party that requested the review withdraws its request within 90 days of the date of publication of the notice of initiation of the requested review. For a full description of the methodology and rationale underlying our conclusions, see the Preliminary Decision Memorandum.

    2 ABF Freight International Private Ltd., Astrotech Steels Private Ltd., Air Sea Transport, Inc., Basso Industry Corporation, Apex Maritime (Fuzhou) Co., Ltd., Blue Moon Logistics Private Ltd., Apex Maritime (Shenzhen) Co., Ltd., Aplus Pneumatic Corp., Bollore Logistics (Taiwan) Ltd., Bollore Logistics (Vietnam) Co. Ltd., Dahnay Logistics Private Ltd., C.H. Robinson Freight Services, DIFS Logistics Co. Ltd., Certified Products Taiwan Inc., Eagre International Trade Co., Ltd., Challenge Industrial Co., Ltd., Easylink Industrial Co., Ltd., Chia Pao Metal Co. Ltd., Encore Green Co., Ltd., China Staple Enterprise Corporation, Everise Global Logistics Co., Ltd., Chite Enterprises Co., Ltd., Faithful Engineering Products Co. Ltd., Crown Run Industrial Corp., Fastenal Asia Pacific Ltd., Freight Links International Ltd., Honour Lane Logistics Co., Ltd., General Merchandise Consolidators, Ginfa World Co. Ltd., HWA Hsing Screw Industry Co. Ltd., Gloex Company, Inmax Industries Sdn Bhd, Hariharan Logistics, Integral Building Products Inc., Hecny Group, Interactive Corporation, Hi-Sharp Industrial Corp. Ltd., Jade Shuttle Enterprise Co., Ltd., Home Value Co., Ltd., Jau Yeou Industry Co. Ltd., Jinhai Hardware Co., Ltd., Nora Freight Services Sdn Bhd, K Win Fasteners Inc., Orient Express Container Co., Ltd., King Freight International Corporation, Orient Star Transport International Ltd., Kuan Hsin Screw Industry Co., Ltd., Pacific Concord International Ltd., Liang Chyuan Industrial Co., Ltd., Patek Tool Co., Ltd., Linkwell Industry Co. Ltd., Pneumax Corp., ML Global Ltd., President Industrial Inc., Maytrans International Corp., Newrex Screw Corporation, Qi Ding Enterprise Co. Ltd., T.H.I. Logistics Co. Ltd., Quick Advance Inc., Tag Fasteners Sdn Bhd, Ray Fu Enterprise Co., Ltd., Taiwan Wakisangyo Co. Ltd., Region Systen Sdn Bhd, Tianjin Jinchi Metal Products Co. Ltd., TK Logistics International Co. Ltd., Schenker (H.K.) Ltd. Taiwan Branch, Topocean Consolidation Service Ltd., Shang Jeng Nail Co., Ltd., Transworld Transportation Co. Ltd., Suntec Industries Co., Ltd., Unicom International Tower, Trim International Inc., Tsi-Translink (Taiwan) Co. Ltd., WTA International Co. Ltd., U-Can-Do Hardware Corp., Yeun Chang Hardware Tool Co. Ltd., United Nail Products Co. Ltd., Yu Tai World Co., Ltd., UPS Supply Chain Solutions, and Zon Mon Co. Ltd.

    Preliminary Results of the Review

    As a result of this review, we preliminarily determine that the following weighted-average dumping margins exist:

    Producer/exporter Dumping margin (percent) Bonuts Logistics Co., LLC 78.17 PT Enterprise, Inc./Pro-Team Coil Nail Enterprise, Inc 78.17 Unicatch Industrial Co. Ltd 34.20 Non-Examined Companies 3 34.20 Disclosure and Public Comment

    The Department intends to disclose to interested parties the calculations performed in connection with these preliminary results within five days of the date of publication of this notice.4 Interested parties may submit cases briefs no later than 30 days after the date of publication of this notice.5 Rebuttal briefs, limited to issues raised in the case briefs, may be filed not later than five days after the due date for filing case briefs.6 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.7 Case and rebuttal briefs should be filed using ACCESS.8 In order to be properly filed, ACCESS must successfully receive an electronically filed document in its entirety by 5 p.m. Eastern Time.

    3 The non-examined companies are Hor Liang Industrial Corp., and Romp Coil Nails Industries Inc.

    4See 19 CFR 351.224(b).

    5See 19 CFR 351.309(c)(1)(ii).

    6See 19 CFR 351.309(d).

    7See 19 CFR 351.309(c)(2) and (d)(2).

    8See 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, filed electronically via ACCESS, within 30 days after the date of publication of this notice.9 Requests should contain: (1) The party's name, address, and telephone number; (2) the number of participants; and (3) a list of issues to be discussed. Issues raised in the hearing will be limited to those raised in the respective case and rebuttal briefs.

    9See 19 CFR 351.310(c).

    Unless otherwise extended, the Department intends to issue the final results of this administrative review, including the results of its analysis of the issues raised in any written briefs, not later than 120 days after the date of publication of this notice, pursuant to section 751(a)(3)(A) of the Act.

    Assessment Rates

    Upon completion of the administrative review, the Department shall determine, and CBP shall assess, antidumping duties on all appropriate entries in accordance with 19 CFR 351.212(b)(1). We intend to issue instructions to CBP 15 days after the date of publication of the final results of this 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).10 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- (or customer-) specific assessment rates based on the resulting per-unit rates.11 Where an importer- (or customer-) specific ad valorem or per-unit rate is greater than de minimis (i.e., 0.50 percent), the Department will instruct CBP to collect the appropriate duties at the time of liquidation.12 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.13

    10See 19 CFR 351.212(b)(1).

    11Id.

    12Id.

    13See 19 CFR 351.106(c)(2).

    For the companies which were not selected for individual review, we will assign an assessment rate based on the methodology described in the “Rates for Non-Examined Companies” section, above.

    Consistent with the Department's assessment practice, for entries of subject merchandise during the POR produced by Bonuts, PT, Unicatch, or the non-examined companies, for which the producer did not know that its merchandise was destined for the United States, we will instruct CBP to liquidate unreviewed entries at the all-others rate if there is no rate for the intermediate company(ies) involved in the transaction.14

    14 For a full discussion of this practice, see Antidumping and Countervailing Duty Proceedings: Assessment of Antidumping Duties, 68 FR 23954 (May 6, 2003).

    For the firms covered by this review, we intend to issue liquidation instructions to CBP 15 days after publication of the final results of this review. For the non-reviewed firms for which we are rescinding this administrative review, the Department intends to instruct CBP 15 days after publication of these preliminary results of review to assess antidumping duties at rates equal to the rates of cash deposits for estimated antidumping duties required at the time of entry, or withdrawn from warehouse, for consumption, during the period May 20, 2015, through June 30, 2016, in accordance with 19 CFR 351.212(c)(2).

    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 Bonuts, PT, and Unicatch will be equal to the weighted-average dumping margin established in the final results of this review, except if the rate is zero or de minimis within the meaning of 19 CFR 351.106(c)(1), in which case the cash deposit rate will be zero; (2) for other manufacturers 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 most recently completed segment of this proceeding in which that manufacturer or exporter participated; (3) if the exporter is not a firm covered in this review, a prior review, or the original less-than-fair-value (LTFV) investigation, but the manufacturer is, then the cash deposit rate will be the rate established for the most recently completed segment of this proceeding for the manufacturer of subject merchandise; and (4) the cash deposit rate for all other manufacturers or exporters will continue to be 2.24 percent, the all-others rate in the LTFV investigation.15 These cash deposit requirements, when imposed, shall remain in effect until further notice.

    15See Certain Steel Nails from Taiwan: Final Determination of Sales at Less Than Fair Value, 80 FR 28959 (May 20, 2015).

    Notifications

    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 Secretary'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.

    Dated: July 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. Preliminary Determination of No Shipments 5. Affiliation and Collapsing 6. Adverse Facts Available 7. Comparisons to Normal Value 8. Date of Sale 9. Export Price and Constructed Export Price 10. Normal Value 11. Currency Conversion 12. Recommendation
    [FR Doc. 2017-16498 Filed 8-4-17; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-570-985] Xanthan Gum From the People's Republic of China: Preliminary Results of the Antidumping Duty Administrative Review and Preliminary Determination of No Shipments; 2015-2016 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 xanthan gum from the People's Republic of China (PRC). The period of review (POR) is July 1, 2015, through June 30, 2016. The review covers two mandatory respondents, Fufeng (which includes Neimenggu Fufeng Biotechnologies Co., Ltd. (a.k.a., Inner Mongolia Fufeng Biotechnologies Co., Ltd.), Xinjiang Fufeng Biotechnologies Co., Ltd., and Shandong Fufeng Fermentation Co., Ltd.) and Deosen (which includes Deosen Biochemical Ltd. and Deosen Biochemical (Ordos) Ltd.).

    We preliminarily determine that sales of subject merchandise by Deosen have been made at prices below normal value (NV), and that sales of subject merchandise by Fufeng have not. We also preliminarily grant separate rates to four exporter groupings listed in the “Preliminary Results of Review” section of this notice and included Hebei Xinhe Biochemical Co., Ltd. as part of the PRC-wide entity. Finally, we preliminarily find that A.H.A. International Co., Ltd. (AHA) made no shipments of subject merchandise during the POR. We invite interested parties to comment on these preliminary results.

    DATES:

    Applicable August 7, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Brian Smith, Jesus Saenz, or Michael Bowen, AD/CVD Operations, Office VIII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-1766, (202) 482-8184, and (202) 482-0768, respectively.

    SUPPLEMENTARY INFORMATION:

    Scope of the Order

    The product covered by the order includes dry xanthan gum, whether or not coated or blended with other products. Xanthan gum is included in this order regardless of physical form, including, but not limited to, solutions, slurries, dry powders of any particle size, or unground fiber.

    Merchandise covered by the scope of the order is classified in the Harmonized Tariff Schedule of the United States at subheading 3913.90.20. This tariff classification is provided for convenience and customs purposes; however, the written description of the scope is dispositive. A full description of the scope of the order is contained in the Preliminary Decision Memorandum.1

    1 For a complete description of the Scope of the Order, see “Decision Memorandum for the Preliminary Results of Antidumping Duty Administrative Review: Xanthan Gum from the People's Republic of China; 2015-2016,” (Preliminary Decision Memorandum) from James P. Maeder, Jr., 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, dated concurrently with, and hereby adopted by, this notice.

    Preliminary Determination of No Shipments

    On October 19, 2016, AHA submitted a timely filed certification that it had no exports, sales, or entries of subject merchandise during the POR.2 Based on an analysis of U.S. Customs and Border Protection (CBP) information and AHA's no shipment certification, the Department preliminarily determines that AHA had no shipments, and, therefore, no reviewable transactions, during the POR. For additional information regarding this determination, see the Preliminary Decision Memorandum.

    2See letter from AHA, “Xanthan Gum from the People's Republic of China Separate Rate Certification of AHA,” dated October 19, 2016.

    Consistent with our practice in non-market economy (NME) cases, the Department is not rescinding this administrative review with respect to AHA, for which it has preliminarily found no shipments during the POR, but intends to complete the review, and issue appropriate instructions to CBP based on the final results of the review.3

    3See Non-Market Economy Antidumping Proceedings: Assessment of Antidumping Duties, 76 FR 65694, 65694-95 (October 24, 2011) (NME AD Assessment) and the “Assessment Rates” section, below.

    Methodology

    The Department is conducting this review in accordance with section 751(a)(1)(B) of the Tariff Act of 1930, as amended (the Act). We calculated, where applicable, export price and constructed export price for the mandatory respondents, Deosen and Fufeng, in accordance with section 772 of the Act. Because the PRC is a NME within the meaning of section 771(18) of the Act, we calculated NV in accordance with section 773(c) of the Act.

    For a full description of the methodology underlying our conclusions, see the Preliminary Decision Memorandum, which is hereby adopted by this notice. The Preliminary Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at https://access.trade.gov, and to all parties in the Central Records Unit, Room B8024 of the main Department of Commerce building. In addition, a complete version of the Preliminary Decision Memorandum can be accessed directly at http://enforcement.trade.gov/frn/. The signed Preliminary Decision Memorandum and the electronic version of the Preliminary Decision Memorandum are identical in content. A list of topics included in the Preliminary Decision Memorandum is provided as an appendix to this notice.

    Verification

    As provided in sections 782(i)(3)(A) and (B) of the Act, we conducted verification of the information upon which we relied in determining the preliminary results of review with respect to the two mandatory respondents, Deosen and Fufeng.

    Preliminary Results of Review

    Based on record evidence, the Department preliminarily continues to treat Deosen Biochemical Ltd. and Deosen Biochemical (Ordos) Ltd. as a single entity for AD purposes. Furthermore, based on record evidence, the Department preliminarily finds that Neimenggu Fufeng Biotechnologies Co., Ltd. (aka Inner Mongolia Fufeng Biotechnologies Co., Ltd.), Shandong Fufeng Fermentation Co. Ltd., and Xinjiang Fufeng Biotechnologies Co., Ltd. are affiliated and should be treated as a single entity for AD purposes. For additional information, see the Preliminary Decision Memorandum. The Department preliminarily finds that one company, Hebei Xinhe Biochemical Co., Ltd., for which a review was requested, did not establish eligibility for a separate rate because it failed to provide a separate rate certification. As such, we preliminarily find that this company is part of the PRC-wide entity.4

    4 Because no interested 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, we did not conduct a review of the PRC-wide entity. Thus, the rate for the PRC-wide entity is not subject to change as a result of this review and remains at 154.07 percent. See Antidumping Proceedings: Announcement of Change in Department Practice for Respondent Selection in Antidumping Duty Proceedings and Conditional Review of the Nonmarket Economy Entity in NME Antidumping Duty Proceedings, 78 FR 65963, 65969-70 (November 4, 2013).

    In addition to the mandatory respondents, we preliminarily determine that CP Kelco (Shandong) Biological Company Limited, Jianlong Biotechnology Co., Ltd. (a.k.a. Inner Mongolia Jianlong Biochemical Co., Ltd.), Meihua Group International Trading (Hong Kong) Limited/Xinjiang Meihua Amino Acid Co., Ltd./Langfang Meihua Bio-Technology Co., Ltd. (“collectively” Meihua), and Shanghai Smart Chemicals Co., Ltd., also demonstrated their eligibility for a separate rate in this administrative review. Consistent with the Department's practice, we preliminarily assigned these companies a rate equal to the weighted-average dumping margin assigned to Deosen in this review. We preliminarily determine that Deosen did not cooperate to the best of its ability in this administrative review with regards to a portion of its sales to AHA, and as a result, we have based its dumping margin for those sales on adverse facts available for these preliminary results.5 For companies subject to this review that have established their eligibility for a separate rate, the Department preliminarily determines that the following weighted-average dumping margins exist for the period July 1, 2015, through June 30, 2016:

    5See Preliminary Decision Memorandum.

    6See Stainless Steel Bar From India: Final Results of the Antidumping Duty Administrative Review, 77 FR 39467 (July 3, 2012) and accompanying Issues and Decision Memorandum at 12.

    Exporters Weighted-
  • average
  • dumping
  • margin
  • (percent)
  • Deosen Biochemical Ltd./Deosen Biochemical (Ordos) Ltd 9.30 Neimenggu Fufeng Biotechnologies Co., Ltd. (aka Inner Mongolia Fufeng Biotechnologies Co., Ltd.)/Shandong Fufeng Fermentation Co., Ltd./Xinjiang Fufeng Biotechnologies Co., Ltd 0.00 CP Kelco (Shandong) Biological Company Limited * 9.30 Jianlong Biotechnology Co., Ltd. (aka Inner Mongolia Jianlong Biochemical Co., Ltd.) * 9.30 Meihua Group International Trading (Hong Kong) Limited/Langfang Meihua Bio-Technology Co., Ltd./Xinjiang Meihua Amino Acid Co., Ltd * 9.30 Shanghai Smart Chemicals Co., Ltd. (Shanghai Smart) * 9.30 * This company demonstrated that it qualified for a separate rate in this administrative review. Consistent with the Department's practice, we preliminarily assigned this company a weighted-average dumping margin of 9.30 percent—the rate calculated for the mandatory respondent Deosen in this review.6 See the Preliminary Decision Memorandum.
    Disclosure

    The Department intends to disclose to the parties the calculations performed for these preliminary results within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b). Interested parties may submit case briefs no later than 30 days after the date of publication of these preliminary results of review.7 Rebuttals to case briefs may be filed no later than five days after the written comments are filed, and all rebuttal comments must be limited to comments raised in the case briefs.8

    7See 19 CFR 351.309(c).

    8See 19 CFR 351.309(d).

    Public Comment

    Case briefs or other written comments may be submitted to the Assistant Secretary for Enforcement and Compliance no later than 30 days after the publication of these preliminary results, unless the Secretary alters the time limit. Rebuttal briefs, limited to issues raised in case briefs, may be submitted no later than five days after the deadline date for case briefs.9 Pursuant to 19 CFR 351.309(c)(2) and (d)(2), parties who submit case briefs or rebuttal briefs in this review 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.

    9See 19 CFR 351.309; see also 19 CFR 351.303 (for general filing requirements).

    Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing, limited to issues raised in the case and rebuttal briefs, must submit a written request to the Assistant Secretary for Enforcement and Compliance, U.S. Department of Commerce, within 30 days after the date of publication of this notice. Requests should contain the party's name, address, and telephone number, the number of participants, whether any participant is a foreign national, and a list of the issues to be discussed. 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 time and date to be determined. Parties should confirm by telephone the date, time, and location of the hearing two days before the scheduled date.

    Unless otherwise extended, the Department intends to issue the final results of this administrative review, which will include the results of our analysis of the 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

    Upon issuance of the final results, the Department will determine, and CBP shall assess, antidumping duties on all appropriate entries covered by this review.10 The Department intends to issue appropriate assessment instructions to CBP 15 days after the publication of the final results of this review.

    10See 19 CFR 351.212(b)(1).

    For each individually-examined respondent in this review, if we continue to calculate a weighted-average dumping margin that is not zero or de minimis (i.e., less than 0.5 percent) in the final results, we will calculate importer-specific assessment rates based on the ratio of the total amount of dumping calculated for the importer's examined sales and the total entered value of those sales, in accordance with 19 CFR 351.212(b)(1).11 We will instruct CBP to assess antidumping duties on all appropriate entries covered by this review when the importer-specific ad valorem assessment rate calculated in the final results of this review is not zero or de minimis. Where either the respondent's ad valorem weighted-average dumping margin is zero or de minimis, or an importer-specific ad valorem assessment rate is zero or de minimis, 12 we will instruct CBP to liquidate the appropriate entries without regard to antidumping duties.

    11 In these preliminary results, the Department applied the assessment rate calculation method adopted in Antidumping Proceedings: Calculation of the Weighted-Average Dumping Margin and Assessment Rate in Certain Antidumping Proceedings: Final Modification, 77 FR 8101 (February 14, 2012).

    12See 19 CFR 351.106(c)(2).

    For the respondents that were not selected for individual examination in this administrative review but qualified for a separate rate, the assessment rate will be equal to the weighted-average dumping margin assigned to Deosen in the final results of this review.13

    13See Drawn Stainless Steel Sinks from the People's Republic of China: Preliminary Results of the Antidumping Duty Administrative Review and Preliminary Determination of No Shipments: 2014-2015, 81 FR 29528 (May 12, 2016) and accompanying Decision Memorandum at 10-11; unchanged in Drawn Stainless Steel Sinks from the People's Republic of China: Final Results of Antidumping Duty Administrative Review; Final Determination of No Shipments; 2014-2015, 81 FR 54042 (August 15, 2016).

    For entries that were not reported in the U.S. sales databases submitted by the companies individually examined during this review, the Department will instruct CBP to liquidate such entries at the PRC-wide rate. In addition, if we continue to find that AHA had no shipments of the subject merchandise, any suspended entries of subject merchandise from AHA will be liquidated at the PRC-wide rate.14

    14 For a full discussion of this practice, see NME AD Assessment.

    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 companies listed above that have a separate rate, the cash deposit rate will be that rate established in the final results of this review (except, if the rate is zero or de minimis, then a cash deposit rate of zero will be required); (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; (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 rate for the PRC-wide entity, which is 154.07 percent; and (4) for all non-PRC exporters of subject merchandise that have not received their own rate, the cash deposit rate will be the rate applicable to the PRC exporter(s) 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) to file a certificate regarding the reimbursement of antidumping and/or countervailing 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 and/or countervailing duties occurred and the subsequent assessment of double antidumping duties.

    We are issuing and publishing these preliminary results of review in accordance with sections 751(a)(l) and 777(i)(l) of the Act and 19 CFR 351.213.

    Dated: July 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

    I. Summary II. Background III. Period of Review IV. Scope of the Order V. Selection of Respondents VI. Preliminary Determination of No Shipments VII. Application of Partial Adverse Facts Available and Selection of Adverse Facts Available Rate VIII. Single Entity Treatment IX. Discussion of the Methodology A. Non-Market Economy Country Status B. Separate Rates Determination 1. Absence of De Jure Control 2. Absence of De Facto Control C. Weighted-Average Dumping Margin for Non-Examined Separate-Rate Companies D. Surrogate Country and Surrogate Value Data 1. Surrogate Country Selection 2. Economic Comparability 3. Significant Producer of Comparable Merchandise 4. Data Availability E. Date of Sale F. Comparisons to Normal Value 1. Determination of Comparison Method 2. Results of the Differential Pricing Analysis G. U.S. Price 1. Export Price 2. Constructed Export Price 3. Value-Added Tax H. Normal Value 1. Factor Valuation Methodology I. Currency Conversion X. Recommendation [FR Doc. 2017-16574 Filed 8-4-17; 8:45 am] BILLING CODE 3510-DS-P DEPARTMENT OF COMMERCE International Trade Administration [A-580-874] Certain Steel Nails From the Republic of Korea: Preliminary Results of Antidumping Duty Administrative Review and Partial Rescission of Antidumping Duty Administrative Review; 2014-2016 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 certain steel nails (steel nails) from the Republic of Korea (Korea). The period of review (POR) is December 29, 2014, through June 30, 2016. This administrative review covers three exporters of the subject merchandise, including two mandatory respondents, Daejin Steel Co. (Daejin) and Korea Wire Co., Ltd. (Kowire). The Department preliminarily determines Daejin sold subject merchandise at less than normal value during the POR and that Kowire did not. The Department is rescinding this administrative review, in part, with respect to 208 companies, based on the timely withdrawal of Mid Continent Steel & Wire, Inc.'s (the petitioner) request for administrative review. Interested parties are invited to comment on these preliminary results.

    DATES:

    Applicable August 7, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Robert Galantucci or Trisha Tran, AD/CVD Operations, Office IV, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-2923 or (202) 482-4852, respectively.

    SUPPLEMENTARY INFORMATION: Background

    On July 5, 2016, the Department notified interested parties of the opportunity to request an administrative review of orders, findings, or suspended investigations with anniversaries in July 2016, including the antidumping duty (AD) order on steel nails from Korea.1 The Department received timely requests from Je-il Wire Production Co., Ltd. (Je-il),2 Daejin,3 Kowire,4 and the petitioner 5 to conduct an administrative review of certain exporters during the POR. On September 12, 2016, the Department published a notice initiating an AD administrative review of steel nails from Korea covering 211 companies for the POR.6

    1See Antidumping or Countervailing Duty Order, Finding, or Suspended Investigation; Opportunity to Request Administrative Review, 81 FR 43584 (July 5, 2016).

    2 See Letter from Je-il, “Certain Steel Nails from the Republic of Korea: Request for Administrative Review,” dated July 22, 2016.

    3See Letter from Daejin, “Certain Steel Nails from the Republic of Korea: Request for Administrative Review,” dated July 28, 2016.

    4See Letter from Kowire, “Steel Nails from the Republic of Korea: Request for Administrative Review,” dated July 29, 2016.

    5See Letter from the petitioner, “Certain Steel Nails from the Republic of Korea: Request for Administrative Reviews,” dated August 1, 2016.

    6See Initiation of Antidumping and Countervailing Duty Administrative Reviews, 81 FR 62720 (September 12, 2016) (Initiation Notice).

    In the Initiation Notice, the Department indicated that, in the event that we limited the respondents selected for individual examination in accordance with section 777A(c)(2) of the Tariff Act of 1930, as amended (the Act), we would select mandatory respondents for individual examination based on U.S. Customers and Border Protection (CBP) entry data.7 On November 7, 2016, after considering the large number of potential producers/exporters involved in this administrative review, and the resources available to the Department, we determined that it was not practicable to examine all exporters/producers of subject merchandise for which a review was requested.8 As a result, pursuant to section 777A(c)(2)(B) of the Act, we determined that we could reasonably individually examine only the two largest producers/exporters of steel nails from Korea by U.S. entry volume during the POR (i.e., Daejin and Kowire).9 Accordingly, we issued the AD questionnaire to Daejin and Kowire, the two companies selected as mandatory respondents.10 On December 12, 2016, the petitioner timely withdrew its request for administrative review pursuant to 19 CFR 351.213(d)(1) of all previously-identified producers and exporters of steel nails from Korea except for Je-il, Daejin, and Kowire.11

    7Id.

    8See Memorandum, “Antidumping Duty Administrative Review of Certain Steel Nails from the Republic of Korea: Respondent Selection,” dated November 7, 2016 (Respondent Selection Memorandum).

    9See Respondent Selection Memorandum.

    10See Department Letter, “Administrative Review of Certain Steel Nails from Korea: Antidumping Duty Questionnaire,” dated November 8, 2016.

    11See Letter from the petitioner, “Certain Steel Nails from the Republic of Korea: Withdrawal of Request for Administrative Review,” dated December 12, 2016.

    Partial Rescission of Administrative Review

    The Department received timely requests to conduct an administrative review of certain exporters covering the POR. Because the petitioner timely withdrew its requests for review of all of the companies listed in the Initiation Notice, with the exception of Daejin, Je-il, and Kowire, we are rescinding the administrative review with respect to the remaining 208 companies on which we initiated this review pursuant to 19 CFR 351.213(d)(1). For a list of the 208 companies for which we are rescinding this review, see Appendix II to this notice. Accordingly, the remaining three companies subject to the instant review are: Daejin, Je-il, and Kowire.

    Scope of the Order

    The merchandise covered by this order is certain steel nails having a nominal shaft length not exceeding 12 inches.12 Merchandise covered by the order is currently classified under the Harmonized Tariff Schedule of the United States (HTSUS) subheadings 7317.00.55.02, 7317.00.55.03, 7317.00.55.05, 7317.00.55.07, 7317.00.55.08, 7317.00.55.11, 7317.00.55.18, 7317.00.55.19, 7317.00.55.20, 7317.00.55.30, 7317.00.55.40, 7317.00.55.50, 7317.00.55.60, 7317.00.55.70, 7317.00.55.80, 7317.00.55.90, 7317.00.65.30, 7317.00.65.60 and 7317.00.75.00. Certain steel nails subject to this order also may be classified under HTSUS subheadings 7907.00.60.00, 8206.00.00.00 or other HTSUS subheadings. While the HTSUS subheadings are provided for convenience and customs purposes, the written description of the scope of this order is dispositive. For a full description of the scope of the order, see the Preliminary Decision Memorandum.13

    12 The shaft length of certain steel nails with flat heads or parallel shoulders under the head shall be measured from under the head or shoulder to the tip of the point. The shaft length of all other certain steel nails shall be measured overall.

    13 For a complete description of the scope of the products under review, see Memorandum, “Decision Memorandum for Preliminary Results of the 2014-2016 Antidumping Duty Administrative Review of Certain Steel Nails from the Republic of Korea,” dated concurrently with, and hereby adopted by this notice (Preliminary Decision Memorandum). The Preliminary Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at http://access.trade.gov and available to all parties in the Central Records Unit, Room B8024 of the main Department of Commerce building. In addition, a complete version of the Preliminary Decision Memorandum can be accessed directly on the Internet at http://enforcement.trade.gov/frn/. The signed and electronic versions of the Preliminary Decision Memorandum are identical in content.

    Allegations of a Particular Market Situation

    On June 8, 2017, the petitioner submitted a “particular market situation” allegation with respect to the production of steel nails in Korea.14 In light of the timing of the filing of this allegation, the Department did not have the opportunity to consider it for purposes of these preliminary results. We intend to issue our preliminary analysis of the PMS allegation so that parties will have an opportunity to comment prior to the issuance of the final results of this review.

    14See Letter from the petitioner, “Certain Steel Nails from Korea: Particular Market Situation Allegation,” dated June 8, 2017 (PMS Allegation).

    Methodology

    The Department is conducting this review in accordance with section 751(a) of the Act. Export price is calculated in accordance with section 772 of the Act. Normal value is calculated in accordance with section 773 of the Act.

    For a full description of the methodology underlying our conclusions, see the Preliminary Decision Memorandum.15 A list of topics included in the Preliminary Decision Memorandum is included as an Appendix I to this notice.

    15See Preliminary Decision Memorandum.

    Preliminary Results of Review

    As a result of this review, we preliminarily determine the following weighted-average dumping margins for the period December 29, 2014 through June 30, 2016:

    16 This rate is based on the rates for the respondents that were selected for individual review, excluding rates that are zero, de minimis or based entirely on facts available. See section 735(c)(5)(A) of the Act.

    Exporter/producer Weighted-average dumping margin
  • (percent)
  • Daejin Steel Co 2.14 Korea Wire Co., Ltd * 0.16 Je-il Wire Production Co., Ltd 16 2.14 * (de minimis).
    Assessment Rates

    Upon completion of the administrative review, the Department shall determine, and CBP shall assess, antidumping duties on all appropriate entries. The Department intends to issue assessment instructions to CBP 15 days after the date of publication of the final results of this review.

    For any individually examined respondents whose weighted-average dumping margin is above de minimis (i.e., 0.50 percent), we will calculate importer-specific ad valorem duty assessment rates based on the ratio of the total amount of dumping calculated for the importer's examined sales to the total entered value of those same sales in accordance with 19 CFR 351.212(b)(1).17 For entries of subject merchandise during the POR produced by each respondent for which it did not know its merchandise was destined for the United States, we will instruct CBP to liquidate un-reviewed entries at the all-others rate if there is no rate for the intermediate company involved in the transaction.18 We will instruct CBP to assess antidumping duties on all appropriate entries covered by this review when the importer-specific assessment rate calculated in the final results of this review is above de minimis. Where either the respondent's weighted-average dumping margin is zero or de minimis, or an importer-specific assessment rate is zero or de minimis, we will instruct CBP to liquidate the appropriate entries without regard to antidumping duties.

    17 In these preliminary results, the Department applied the assessment rate calculation methodology adopted in Antidumping Proceedings: Calculation of the Weighted-Average Dumping Margin and Assessment Rate in Certain Antidumping Proceedings: Final Modification, 77 FR 8101 (February 14, 2012).

    18See Antidumping and Countervailing Duty Proceedings: Assessment of Antidumping Duties, 68 FR 23954 (May 6, 2003).

    For the 208 companies for which this review is rescinded, antidumping duties will be assessed at rates equal to the cash deposit of estimated antidumping duties required at the time of entry, or withdrawn from warehouse, for consumption, in accordance with 19 CFR 351.212(c)(1)(i). The Department intends to issue appropriate assessment instructions directly to CBP 15 days after publication of this notice. The final results of this review shall be the basis for the assessment of antidumping duties on entries of merchandise covered by the final results of this review and for future deposits of estimated duties, where applicable.

    Cash Deposit Requirement

    The following deposit requirements will be effective upon publication of the notice of the final results of administrative review for all shipments of steel nails from Korea entered, or withdrawn from warehouse, for consumption on or after the date of publication of the final results of this administrative review, as provided by section 751(a)(2)(C) of the Act: (1) The cash deposit rate for the companies under review will be the rate established in the final results of this review (except, if the rate is zero or de minimis, no cash deposit will be required); (2) for merchandise exported by manufacturers or exporters not covered in this review but covered in a prior segment of the proceeding, the cash deposit rate will continue to be the company-specific rate published for the most recently completed segment of this proceeding in which the manufacturer or exporter participated; (3) if the exporter is not a firm covered in this review, a prior review, or the less-than-fair-value investigation, but the manufacturer is, the cash deposit rate will be the rate established for the most recently completed segment of the proceeding for the manufacturer of the merchandise; and (4) the cash deposit rate for all other manufacturers or exporters will continue to be 11.80 percent ad valorem, the all-others rate established in the less-than-fair value investigation.19

    19See Certain Steel Nails from the Republic of Korea: Final Determination of Sales at Less Than Fair Value, 80 FR 28955 (May 20, 2015).

    Disclosure and Public Comment

    The Department intends to disclose the calculations used in our analysis to interested parties in this review within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b). Interested parties are invited to comment on the preliminary results of this review. Pursuant to 19 CFR 351.309(c)(1)(ii), interested parties may submit case briefs no later than 30 days after the date of publication of this notice. Rebuttal briefs, limited to issues raised in the case briefs, may be filed no later than five days after the time limit for filing case briefs.20 Parties who submit case briefs or rebuttal briefs in this proceeding are requested to submit with each brief: (1) A statement of the issue, (2) a brief summary of the argument, and (3) a table of authorities.21 Executive summaries should be limited to five pages total, including footnotes.22 Case and rebuttal briefs should be filed using ACCESS.23

    20See 19 CFR 351.309(d)(1).

    21See 19 CFR 351.309(c)(2) and (d)(2).

    22Id.

    23See 19 CFR 351.303.

    Pursuant to 19 CFR 351.310(c), any interested party may request a hearing within 30 days of the publication of this notice in the Federal Register. If a hearing is requested, the Department will notify interested parties of the hearing schedule. Interested parties who wish to request a hearing, or to participate if one is requested, must submit a written request to the Assistant Secretary for Enforcement and Compliance, filed electronically via ACCESS within 30 days after the date of publication of this notice. Requests should contain: (1) The party's name, address, and telephone number; (2) the number of participants; and (3) a list of the issues to be discussed. Issues raised in the hearing will be limited to those raised in the respective case and rebuttal briefs.

    We intend to issue the final results of this administrative review, including the results of our analysis of issues raised by the parties in the written comments, within 120 days of publication of these preliminary results in the Federal Register, unless otherwise extended.24

    24See section 751(a)(3)(A) of the Act.

    Notification To Importers

    This notice also serves as a preliminary reminder to importers of their responsibility under 19 CFR 351.402(f) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the Department's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.

    Notification To Interested Parties

    We are issuing and publishing this notice in accordance with sections 751(a)(1) and 777(i)(1) of the Act and 19 CFR 351.221(b)(4).

    Dated: July 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 I List of Topics Discussed in the Preliminary Decision Memorandum I. Summary II. Background III. Scope of the Order IV. Rescission In Part V. Non-Selected Respondent Rate VI. Affiliation VII. Discussion of the Methodology A. Determination of Comparison Method B. Results of Differential Pricing Analysis C. Product Comparisons D. Date of Sale E. Export Price F. Normal Value G. Currency Conversions VIII. Recommendation Appendix II 1. AOT Japan Ltd 2. ABF Freight International Private Ltd 3. ABN Fasteners Co. Ltd. 4. Ace Logistics Co., Ltd. (Tianjin Branch) 5. Air Sea Transport Inc. 6. Air Sea Worldwide Logistics Ltd. 7. Alpha Forwarding Co. Ltd. 8. Apex Maritime Co., Inc. (Dalian) 9. Apex Maritime Co. Ltd. (Korea) 10. Apex Maritime (Tianjin) Co., Ltd. 11. Astrotech Steels Private Limited 12. Baoding Jieboshun Trading Corp. Ltd. 13. Beijing Jin Heung Co. Ltd. 14. Beijing Kang Jie Kong Int'l Cargo Co. Ltd. 15. Beijing Qin Li Jeff Trading Co., Ltd. 16. Ben Line Agencies—Tianjin 17. Berry Clark & Co. Ltd. 18. Bipex Co., Ltd. 19. BK Fasteners Co. 20. Blu Logistics (China) Co., Ltd. 21. Bollore Logistics China Co., Ltd 22. Bolung International Trading Co., Ltd. 23. Bon Voyage Logistics Inc. 24. Brilliant Group Logistics Corp. 25. BYK Lines, Incorporated 26. C.H. Robinson Freight Services Ltd. 27. Caesar International Logistics Co. Ltd. 28. Cangzhou Xinqiao Int'l Trade Co. Ltd. 29. Capital Freight Management Inc. 30. Casia Global Logistics Co Ltd 31. Certified Products International Inc. 32. China Abrasives Industry 33. China Staple Enterprise (Tianjin) Co. Ltd 34. CJ Korea Express Co., Ltd. 35. CMS Logistics, Inc. 36. CN Worldwide International Freight 37. Concord Freight System Co., Ltd. 38. Consolidated Shipping Services L.L.C. 39. Cyber Express Corporation 40. D&F Material Products Ltd 41. DCS Dah Star Logistics Co., Ltd. 42. Dahnay Logistics Private Ltd. 43. Daijin Express Co., Ltd. 44. Dingzhou Derunda Material and Trade Co., Ltd. 45. Deugro Emirates Shipping Co. 46. Dezhou Hualude Hardware Products Co., Ltd. 47. Eco Steel Co., Ltd. 48. Duo-Fast Korea Co., Ltd. 49. Easylink Industrial Co., Ltd. 50. Family Express Company Limited 51. Ejem Brothers Limited 52. Euroline Global Co., Ltd. 53. G Link Express Logistics (Korea) Ltd 54. FG International Logistic Ltd 55. Foshan Sanden Enterprise Co., Ltd. 56. Grandlink Logistics Co., Ltd. 57. Global Container Line, Inc. 58. Goodgood Manufacturers 59. Hanbit Logistics Co., Ltd. 60. Grubville Enterprises Corporation 61. Han Duk Industrial Co., Ltd. 62. Hariharan Logistics 63. Hanjin Logistics India Private Ltd. 64. Hanmi Staple Co., Ltd. 65. Hecny Shipping Ltd. 66. Hebei Minmetals Co., Ltd. 67. Hecny Transportation Ltd. 68. High Link Line Inc. 69. Hellmann Worldwide Logistics Inc. 70. Hengtuo Metal Products Co Ltd 71. Huanghua Lianqing Hardware Products 72. Hongyi HK Hardware Products Co. 73. Honour Lane Logistics Sdn Bhd 74. Huanghua Yiqihe Imp. & Exp. Co, Ltd. 75. Huanghua Ruisheng Hardware Products 76. Huanghua Yingjin Hardware Products Co., Ltd. 77. I B International Co., Ltd. 78. Huasheng Yida Tianjin International Trading Co. Ltd. 79. Huazan Metal Wire Mesh Manufacture Co. Ltd. 80. International Maritime and Aviation LLC 81. Inmax Industries Sdn Bhd 82. Inno International 83. Jas Forwarding (Korea) Co. Ltd. 84. Ivk Manuport Logistics LLC 85. J Consol Line Co., Ltd. 86. Jiangsu Globe Logistics Co., Ltd. 87. Jail Tacker Co., Ltd. 88. Jinhai Hardware Co., Ltd. 89. Jinheung Steel Corporation 90. Jiaozuo Deled Hardware Manufacturing Co., Ltd. 91. Jinzhou Yihe Metal Products Co., Ltd. 92. Joo Sung Sea Air Co., Ltd. 93. Jinsco International Corp. 94. Kase Logistics International 95. Kasy Logistics (Tianjin) Co., Ltd. 96. K Logistics Corp. (Korea) 97. King Shipping Company 98. Kongo Special Nail Mfg. Co., Ltd. 99. King Freight International Corp. 100. Koram Steel Co., Ltd. 101. Laapraa Shipping Private Ltd. 102. Koram Inc. 103. Kyungjoo Sejung Corporation 104. Linyi Flying Arrow Imp. & Exp. Ltd. 105. Kuehne Nagel Ltd. (Tianjin Branch) 106. Linyi Double Moon Hardware Products Co., Ltd. 107. Mingguang Ruifeng Hardware Products Co., Ltd. 108. Liaocheng Minghui Hardware Products 109. Micasa Corporation Osaka Japan 110. Neo Gls 111. Liladhar Pasoo India Logistics Private Ltd. 112. Nanjing Caiqing Hardware Co., Ltd. 113. Ocean King Industries Limited 114. Nailtech Co. Ltd. 115. Nippon Seisen Co., Ltd. 116. Oman Fasteners LLC 117. Ningbo Port Southeast Logistics Group Co., Ltd. 118. OEC Logistics Co., Ltd. 119. Overseas Distribution Services Inc. 120. OEC Freight Worldwide Korea Co. Ltd. 121. Orient Express Container Co., Ltd. 122. Panalpina World Transport (PRC) Ltd. 123. On Time Worldwide Logistics Ltd. 124. Pacific Global Logistics Co., Ltd. 125. Prime Global Products Inc. 126. Overseas International Steel Industry 127. Peace Korea Co., Ltd. 128. Pudong Prime International Logistics, Inc. 129. Paslode Fasteners (Shanghai) Co. Ltd. 130. Promising Way (Hong Kong) Limited 131. Qingdao Golden Sunshine Metal Products Co., Ltd. 132. Prime Shipping International Inc. 133. Qingdao Gold-Dragon Co. Ltd. 134. Qingdao Mst Industry and Commerce Co., Ltd. 135. Qingdao D&L Group Ltd. 136. Qingdao Meijialucky Industry and Commerce Co., Ltd. 137. Ramses Logistics Company Limited 138. Qingdao Master Metal Products Co. Ltd. 139. Qingdao Uni-Trend International Limited 140. Romp Coil Nail Industries Inc. 141. Qingdao Tiger Hardware Co., Ltd. 142. Ricoh Logistics System Co., Ltd. 143. SDC International Australia PTY Ltd. 144. Regency Global Logistics (Shanghai) Co., Ltd. 145. Scanwell Container Line Ltd. 146. Sea Master Logistics Ltd. 147. Romp (Tianjin) Hardware Co. Ltd. 148. SDV Vietnam Co. Ltd. 149. Shandong Oriental Cherry Hardware Group 150. SDV PRC International Freight Forwarding Co. Ltd. 151. Shandong Liaocheng Minghua Metal PR 152. Shanghai Kaijun Logistics Co., Ltd. 153. Sejung (China) Sea & Air Co., Ltd. 154. Shanghai Jade Shuttle Hardware Tools Co., Ltd. 155. Shanxi Hairui Trade Co., Ltd. 156. Shanghai Curvet Hardware Products Co., Ltd. 157. Shanghai Pudong International Transportation 158. Shenzhen Syntrans International Logistics Co., Ltd. 159. Shanghai Pinnacle International Trading Co., Ltd. 160. Shanxi Tianli Industries Co., Ltd. 161. Sirius Global Logistics Co. Ltd. 162. Shanxi Pioneer Hardware Industry Co., Ltd. 163. Shipping Imperial Co., Ltd. 164. Suntec Industries Co., Ltd. 165. Shine International Transportation Ltd. 166. S-Mart (Tianjin) Technology Development Co., Ltd. 167. T.H.I. Group (Shanghai) Ltd. 168. Smart Logistics Co., Ltd. 169. Swift Freight (India) Pvt Ltd. 170. Tianjin Bluekin Industries Limited 171. Sunworld Industry Company Limited 172. The Stanley Works (Langfang) Fastening System Co., Ltd. 173. Tianjin Huixinshangmao Co. Ltd. 174. TCW Line Co., Ltd. 175. Tianjin Hongli Qiangsheng Imp. Exp. 176. Tianjin Juxiang Metal Products Co. Ltd. 177. Tianjin Coways Metal Products Co. 178. Tianjin Jinghai County Hongli Industry 179. Tianjin M&C Electronics Co., Ltd. 180. Tianjin Jinchi Metal Products Co., Ltd. 181. Tianjin Lituo Imp. Exp. Co. Ltd. 182. Tianjin Zhonglian Times Technology 183. Tianijn Lianda Group Co., Ltd. 184. Tianjin Zhonglian Metals Ware Co. Ltd. 185. Top Ocean Consolidated Service Ltd. 186. Tianjin Universal Machinery Imp. & Exp. Corp. 187. Top Ocean Korea Limited 188. Trans Wagon Int'l Co., Ltd. 189. Toll Global Forwarding (Beijing) Ltd. 190. Trans Knights, Inc. 191. United Nail Products Co., Ltd. 192. TP Steel Co. Ltd. 193. Unicorn (Tianjin) Fasteners Co., Ltd. 194. V-Line Shipping Co., Ltd. 195. Translink Shipping, Inc. 196. UPS SCS (China) Limited 197. Weifang United Laisee International Trade Co. Ltd. 198. Universal Sea & Air Co., Ltd. 199. Wah Shing Trading Flat RM G 200. Xuzhou CIP International Group Co. Ltd. 201. W&K Corporation Limited 202. Xinjiayuan Trading Co., Limited 203. You-One Fastening Systems 204. Xi'an Metals and Minerals Imp. Exp. Co. 205. Youngwoo Fasteners Co., Ltd. 206. Yicheng Logistics 207. Zhejiang Best Nail Industry Co., Ltd. 208. Zen Continental (Tianjin) Enterprises
    [FR Doc. 2017-16551 Filed 8-4-17; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-570-831] Fresh Garlic From the People's Republic of China: Final Results of Fourth Expedited 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 finds that revocation of the antidumping duty order on fresh garlic would be likely to lead to continuation or recurrence of dumping. The magnitude of the dumping margin likely to prevail is indicated in the “Final Results of Sunset Review” section of this notice.

    DATES:

    Applicable August 7, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Jacqueline Arrowsmith, AD/CVD Operations, Office VII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone 202-482-5255.

    SUPPLEMENTARY INFORMATION: Background

    On April 3, 2017, the Department published the notice of initiation of the fourth sunset review of the antidumping duty order on fresh garlic from the PRC pursuant to section 751(c) of the Tariff Act of 1930, as amended (the Act).1 The Department received a notice of intent to participate from the Fresh Garlic Producers Association and its individual members: Christopher Ranch LLC; The Garlic Company; Valley Garlic, Inc.; and Vessey and Company, Inc. (collectively, the domestic interested parties), within the deadline specified in 19 CFR 351.218(d)(1)(i). The domestic interested parties claimed interested party status under section 771(9)(C) of the Act as domestic producers and packagers of fresh garlic and a trade association whose members produce and process a domestic like product in the United States. The Department received an adequate substantive response to the notice of initiation from the domestic interested parties within the 30-day deadline specified in 19 CFR 351.218(d)(3)(i). We received no responses from the respondent interested parties. 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.

    1See Initiation of Five-Year (“Sunset”) Reviews, 82 FR 16159 (April 3, 2017).

    Scope of the Order

    The products subject to the antidumping duty order are all grades of garlic, whole or separated into constituent cloves, whether or not peeled, fresh, chilled, frozen, provisionally preserved, or packed in water or other neutral substance, but not prepared or preserved by the addition of other ingredients or heat processing. The differences between grades are based on color, size, sheathing, and level of decay.

    The scope of the order does not include the following: (a) Garlic that has been mechanically harvested and that is primarily, but not exclusively, destined for non-fresh use; or (b) garlic that has been specially prepared and cultivated prior to planting and then harvested and otherwise prepared for use as seed.

    The subject merchandise is used principally as a food product and for seasoning. The subject garlic is currently classifiable under subheadings 0703.20.0000, 0703.20.0005, 0703.20.0015, 0703.20,0010, 0703.20.0020, 0703.20.0090, 0710.80.7060, 0710.80.9750, 0711.90.6000, 0711.90.6500, 2005.90.9500, 2005.90.9700 and 2005.99.9700 of the Harmonized Tariff Schedule of the United States (HTSUS). Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of the scope of the order is dispositive. In order to be excluded from the antidumping duty order, garlic entered under the HTSUS subheadings listed above that is (1) mechanically harvested and primarily, but not exclusively, destined for non-fresh use or (2) specially prepared and cultivated prior to planting and then harvested and otherwise prepared for use as seed must be accompanied by declarations to U.S. Customs and Border Protection to that effect.

    Analysis of Comments Received

    All issues raised in this review are addressed in the Issues and Decision Memorandum,2 the likelihood of continuation or recurrence of dumping and the magnitude of the margins likely to prevail if the order is revoked. Parties can find a complete discussion of all issues raised in this review and corresponding recommendations in the Issues and Decision Memorandum, which is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Services System (ACCESS). ACCESS is available to registered users at https://access.trade.gov/login.aspx 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 versions of the Issues and Decision Memorandum are identical in content.

    2See “Issues and Decision Memorandum: Final Results of Expedited Fourth Sunset Review of the Antidumping Duty Order on Fresh Garlic from the People's Republic of China,” from 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, to James Maeder, Senior Director performing the duties of the Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, which is dated concurrently with this Federal Register notice (Issues and Decision Memorandum).

    Final Results of Review

    We determine that revocation of the antidumping duty order on fresh garlic from the PRC would be likely to lead to continuation or recurrence of dumping. We determine that the weighted-average dumping margin likely to prevail is a margin up to 376.67 percent.

    This notice also serves as the only reminder to parties subject to administrative protective order (APO) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305. Timely notification of the return or destruction of APO materials or conversion to judicial protective orders 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.

    Dated: August 1, 2017. Gary Taverman, Deputy Assistant Secretary, performing the non-exclusive functions and duties of the Assistant Secretary for Enforcement and Compliance.
    [FR Doc. 2017-16575 Filed 8-4-17; 8:45 am] BILLING CODE 3510-DS-P
    COMMITTEE FOR PURCHASE FROM PEOPLE WHO ARE BLIND OR SEVERELY DISABLED Procurement List; Proposed Additions and Deletions AGENCY:

    Committee for Purchase From People Who Are Blind or Severely Disabled.

    ACTION:

    Proposed additions to and deletions from the Procurement List.

    SUMMARY:

    The Committee is proposing to add products to the Procurement List that will be furnished by a nonprofit agency employing persons who are blind or have other severe disabilities, and deletes products and services previously furnished by such agencies.

    DATES:

    Comments must be received on or before September 3, 2017.

    ADDRESSES:

    Committee for Purchase from People Who are Blind or Severely Disabled, 1401 S. Clark Street, Suite 715, Arlington, Virginia 22202-4149.

    FOR FURTHER INFORMATION CONTACT:

    For further information or to submit comments contact: Amy B. Jensen, Telephone: (703) 603-7740, Fax: (703) 603-0655, or email [email protected].

    SUPPLEMENTARY INFORMATION:

    This notice is published pursuant to 41 U.S.C. 8503 (a)(2) and 41 CFR 51-2.3. Its purpose is to provide interested persons an opportunity to submit comments on the proposed actions.

    Additions

    If the Committee approves the proposed additions, the entities of the Federal Government identified in this notice will be required to procure the products listed below from the nonprofit agency employing persons who are blind or have other severe disabilities.

    The following products are proposed for addition to the Procurement List for production by the nonprofit agency listed:

    Products NSN(s)—Product Name(s): 7125-00-NIB-0006—Cabinet, Storage, Blow-Molded, 46″, Black 7125-00-NIB-0007—Cabinet, Storage, Blow-Molded, 46″, Platinum 7125-00-NIB-0008—Cabinet, Storage, Blow-Molded, 66″, Black 7125-00-NIB-0009—Cabinet, Storage, Blow-Molded, 66″, Platinum 7125-00-NIB-0010—Cabinet, Storage, Blow-Molded, 72″, Black 7125-00-NIB-0011—Cabinet, Storage, Blow-Molded, 72″, Platinum 7125-00-NIB-0012—Shelf, Open Storage, 4 Shelves, 54″, Platinum 7125-00-NIB-0013—Shelf, Open Storage, 4 Shelves, 54″, Charcoal 7125-00-NIB-0014—Shelf, Open Storage, 4 Shelves, 54″, Black 7125-00-NIB-0015—Shelf, Open Storage, 5 Shelves, 74″, Platinum 7125-00-NIB-0016—Shelf, Open Storage, 5 Shelves, 74″, Charcoal 7125-00-NIB-0017—Shelf, Open Storage, 5 Shelves, 74″, Black Mandatory for: Broad Government Requirement Mandatory Source(s) of Supply: MidWest Enterprises for the Blind, Inc., Kalamazoo, MI Contracting Activity: General Services Administration, Philadelphia, PA Distribution: B-List Deletions

    The following products and services are proposed for deletion from the Procurement List:

    Products NSN(s)—Product Name(s): 6920-01-NSH-9023—Target 6920-01-NSH-9025—Target 6920-01-NSH-9026—Target 6920-01-NSH-9027—Target 6920-01-NSH-9028—Target 6920-01-NSH-9029—Target 6920-01-NSH-9031—Target 6920-01-NSH-9035—Target 6920-01-NSH-9036—Target 6920-01-NSH-9030—Target Mandatory Source(s) of Supply: Walterboro Vocational Rehabilitation Center, Walterboro, SC Contracting Activity: W6QM MICC-FT STEWART, Fort Stewart, GA NSN(s)—Product Name(s): 8410-01-474-6871—Slacks, Dress, Belted, Navy, Women's, White, 20WR 8410-01-474-6872—Slacks, Dress, Belted, Navy, Women's, White, 20WR Mandatory Source(s) of Supply: Goodwill Industries of South Florida, Inc., Miami, FL Contracting Activity: Defense Logistics Agency Troop Support NSN(s)—Product Name(s): 8405-00-NSH-1415—XXX Large Tall 8405-00-NSH-1407—Medium Tall 8405-00-NSH-1409—Large Tall 8405-00-NSH-1411—X Large Tall 8405-00-NSH-1413—XX Large Tall Mandatory Source(s) of Supply: Human Technologies Corporation, Utica, NY Contracting Activity: USDA APHIS MRPBS, Minneapolis, MN NSN(s)—Product Name(s): 8410-00-NSH-6328—size 2 8410-00-NSH-6357—XXXX Large 8410-00-NSH-6383—XXXX Large Tall 8410-00-NSH-6364—XXXX Large 8410-00-NSH-6390—XXXX Large Tall 8410-00-NSH-6403—XXXX Large 8410-00-NSH-6404—XXXX Large Tall 8405-00-NSH-1332—Medium Tall 8405-00-NSH-1333—Large Tall 8405-00-NSH-1334—X Large Tall 8405-00-NSH-1335—XX Large Tall 8405-00-NSH-1336—XXX Large Tall 8405-00-NSH-1337—Medium Tall 8405-00-NSH-1338—Large Tall 8405-00-NSH-1339—X Large Tall 8405-00-NSH-1340—XX Large Tall 8405-00-NSH-1341—XXX Large Tall 8405-00-NSH-1342—Medium Tall 8405-00-NSH-1387—Medium Tall 8405-00-NSH-1389—Large Tall 8405-00-NSH-1391—X Large Tall 8405-00-NSH-1393—XX Large Tall 8405-00-NSH-1395—XXX Large Tall 8405-00-NSH-1397—Medium Tall 8405-00-NSH-1399—Large Tall 8405-00-NSH-1401—X Large Tall 8405-00-NSH-1403—XX Large Tall 8405-00-NSH-1405—XXX Large Tall 8405-00-NSH-1417—Medium Tall 8405-00-NSH-1419—Large Tall 8405-00-NSH-1421—X Large Tall 8405-00-NSH-1423—XX Large Tall 8405-00-NSH-1425—XXX Large Tall Mandatory Source(s) of Supply: Human Technologies Corporation, Utica, NY Contracting Activity: AMS 31C3, Washington, DC Services Service Type: Janitorial/Custodial Service Mandatory for: NAVFAC Southwest, Marine Corps Reserve Center Bakersfield, CA Mandatory Source(s) of Supply: Bakersfield Arc, Inc., Bakersfield, CA Contracting Activity: DEPT OF THE NAVY, NAVFAC SOUTHWEST Service Type: Janitorial/Custodial Service Mandatory for: Naval & Marine Corps Reserve Center, Mobile, AL Mandatory Source(s) of Supply: GWI Services, Inc., Mobile, AL Contracting Activity: DEPT OF THE NAVY, NAVY FACILITIES ENGINEERING COMMAND Service Type: Grounds Maintenance Service Mandatory for: Naval Air Station, Joint Reserve Base, Fort Worth, TX Mandatory Source(s) of Supply: Trace, Inc., Boise, ID Contracting Activity: DEPT OF THE NAVY, US FLEET FORCES COMMAND Service Type: Facilities Maintenance Service Mandatory for: Greater Louisville Technology Park: Port Hueneme Detachment & Navy Caretaker Site Off, Louisville, KY Mandatory Source(s) of Supply: Employment Source, Inc., Fayetteville, NC Contracting Activity: DEPT OF THE NAVY, NAVAL FAC ENGINEEERING CMD MIDWEST Amy B. Jensen, Director, Business Operations.
    [FR Doc. 2017-16472 Filed 8-4-17; 8:45 am] BILLING CODE 6353-01-P
    COMMITTEE FOR PURCHASE FROM PEOPLE WHO ARE BLIND OR SEVERELY DISABLED Procurement List: Addition AGENCY:

    Committee for Purchase from People Who are Blind or Severely Disabled.

    ACTION:

    Addition to the Procurement List.

    SUMMARY:

    This action adds a service to the Procurement List that will be provided by a nonprofit agency employing persons who are blind or have other severe disabilities.

    DATES:

    Date added to the Procurement List: September 3, 2017.

    ADDRESSES:

    Committee for Purchase from People Who are Blind or Severely Disabled, 1401 S. Clark Street, Suite 715, Arlington, Virginia 22202-4149.

    FOR FURTHER INFORMATION CONTACT:

    Amy B. Jensen, Telephone: (703) 603-7740, Fax: (703) 603-0655, or email [email protected]

    SUPPLEMENTARY INFORMATION:

    Addition

    On 6/30/2017 (82 FR 29852), the Committee for Purchase from People Who are Blind or Severely Disabled published notice of proposed addition to the Procurement List.

    After consideration of the material presented to it concerning capability of qualified nonprofit agency to provide the service and impact of the addition on the current or most recent contractor, the Committee has determined that the service listed below is suitable for procurement by the Federal Government under 41 U.S.C. 8501-8506 and 41 CFR 51-2.4.

    Regulatory Flexibility Act Certification

    I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:

    1. The action will not result in any additional reporting, recordkeeping or other compliance requirements for small entities other than the small organization that will provide the service to the Government.

    2. The action will result in authorizing small entities to provide the service to the Government.

    3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 8501-8506) in connection with the service proposed for addition to the Procurement List.

    End of Certification

    Accordingly, the following service is added to the Procurement List:

    Service Service Type: Base Supply Center Service Mandatory for: US Air Force, Robins Air Force Base, 375 Perry Street, Robins AFB, GA Mandatory Source(s) of Supply: Alabama Industries for the Blind, Talladega, AL Contracting Activity: Dept of the Air Force, FA8501 AFSC PZIO. Amy B. Jensen, Director, Business Operations.
    [FR Doc. 2017-16473 Filed 8-4-17; 8:45 am] BILLING CODE 6353-01-P
    DEPARTMENT OF DEFENSE Office of the Secretary Uniform Formulary Beneficiary Advisory Panel; Notice of Federal Advisory Committee Meeting AGENCY:

    Under Secretary of Defense for Personnel and Readiness, Department of Defense.

    ACTION:

    Notice of Federal Advisory Committee meeting.

    SUMMARY:

    The Department of Defense (DoD) is publishing this notice to announce that the following Federal Advisory Committee meeting of the Uniform Formulary Beneficiary Advisory Panel will take place.

    DATES:

    Open to the public Thursday, September 21, 2017 from 9:00 a.m. to 12:00 p.m.

    ADDRESSES:

    The address of the open meeting is the Naval Heritage Center Theater, 701 Pennsylvania Avenue NW., Washington, DC 20004.

    FOR FURTHER INFORMATION CONTACT:

    Edward Norton, 703-681-2890 (Voice), 703-681-1940 (Facsimile), [email protected] (Email). Mailing address is 7700 Arlington Boulevard, Suite 5101, Falls Church, VA 22042-5101. Web site: http://www.health.mil/About-MHS/Other-MHS-Organizations/Beneficiary-Advisory-Panel. The most up-to-date changes to the meeting agenda can be found on the Web site.

    SUPPLEMENTARY INFORMATION:

    This meeting is being held under the provisions of the Federal Advisory Committee Act (FACA) of 1972 (5 U.S.C., Appendix, as amended), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended), and 41 CFR 102-3.140 and 102-3.150.

    Administrative Work Meeting: Prior to the public meeting, the Panel will conduct an Administrative Work Meeting from 8:30 a.m. to 9:00 a.m. to discuss administrative matters of the Panel. The Administrative Work Meeting will be held at the Naval Heritage Center, 701 Pennsylvania Avenue NW., Washington, DC 20004. Pursuant to 41 CFR 102-3.160, the Administrative Work Meeting will be closed to the public.

    Purpose of the Meeting: Summary: The Department of Defense is publishing this notice to announce a Federal Advisory Committee meeting of the Uniform Formulary Beneficiary Advisory Panel (hereafter referred to as the Panel). Purpose: The Panel will review and comment on recommendations made to the Director of the Defense Health Agency, by the Pharmacy and Therapeutics Committee, regarding the Uniform Formulary.

    Agenda: Meeting Agenda: 1. Sign-In 2. Welcome and Opening Remarks 3. Public Citizen Comments 4. Scheduled Therapeutic Class Reviews (Comments will follow each agenda item) a. HIV Antiretroviral Agents. b. Basal Insulin Agents. c. Hereditary Angioedema Agents. 5. Newly Approved Drugs Review. 6. Pertinent Utilization Management Issues. 7. Panel Discussions and Vote.

    Meeting Accessibility: Pursuant to 5 U.S.C. 552b, as amended, and 41 Code of Federal Regulations (CFR) 102-3.140 through 102-3.165, and the availability of space, this meeting is open to the public. Seating is limited and will be provided only to the first 220 people signing-in. All persons must sign-in legibly.

    Written Statements: Pursuant to 41 CFR 102-3.140, the public or interested organizations may submit written statements to the membership of the Panel at any time or in response to the stated agenda of a planned meeting. Written statements should be submitted to the Panel's Designated Federal Officer (DFO). The DFO's contact information can be obtained from the General Services Administration's Federal Advisory Committee Act Database at http://facadatabase.gov/. Written statements that do not pertain to the scheduled meeting of the Panel may be submitted at any time. However, if individual comments pertain to a specific topic being discussed at a planned meeting, then these statements must be submitted no later than 5 business days prior to the meeting in question. The DFO will review all submitted written statements and provide copies to all the committee members.

    Public Comments: In addition to written statements, the Panel will set aside 1 hour for individuals or interested groups to address the Panel. To ensure consideration of their comments, individuals and interested groups should submit written statements as outlined in this notice; but if they still want to address the Panel, then they will be afforded the opportunity to register to address the Panel. The Panel's DFO will have a “Sign-Up Roster” available at the Panel meeting for registration on a first-come, first-serve basis. Those wishing to address the Panel will be given no more than 5 minutes to present their comments, and at the end of the 1-hour time period, no further public comments will be accepted. Anyone who signs-up to address the Panel, but is unable to do so due to the time limitation, may submit their comments in writing; however, they must understand that their written comments may not be reviewed prior to the Panel's deliberation.

    Dated: August 2, 2017. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense.
    [FR Doc. 2017-16587 Filed 8-4-17; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF DEFENSE Office of the Secretary [Docket ID: DOD-2016-OS-0069] Submission for OMB Review; Comment Request AGENCY:

    Office of the Under Secretary of Defense for Acquisition, Technology and Logistics, DoD.

    ACTION:

    30-Day information collection notice.

    SUMMARY:

    The Department of Defense has submitted to OMB for clearance, the following proposal for collection of information under the provisions of the Paperwork Reduction Act.

    DATES:

    Consideration will be given to all comments received by September 6, 2017.

    ADDRESSES:

    Comments and recommendations on the proposed information collection should be emailed to Ms. Jasmeet Seehra, DoD Desk Officer, at [email protected] Please identify the proposed information collection by DoD Desk Officer and the Docket ID number and title of the information collection.

    FOR FURTHER INFORMATION CONTACT:

    Fred Licari, 571-372-0493, or [email protected]

    SUPPLEMENTARY INFORMATION:

    Title, Associated Form and OMB Number: Revitalizing Base Closure Communities, Economic Development Conveyance Annual Financial Statement; OMB Control Number 0790-0004.

    Type of Request: Reinstatement with change.

    Number of Respondents: 29.

    Responses per Respondent: 1.

    Annual Responses: 29.

    Average Burden per Response: 40 hours.

    Annual Burden Hours: 1,160 hours.

    Needs and Uses: The information collection requirement is necessary to verify that Local Redevelopment Authority (LRA) recipients of Economic Development Conveyances (EDCs) are in compliance with the requirement that the LRA reinvest proceeds from the use of EDC property for seven years.

    Affected Public: State, local, or tribal governments.

    Frequency: Annually.

    Respondent’s Obligation: Voluntary.

    OMB Desk Officer: Ms. Jasmeet Seehra.

    You may also submit comments and recommendations, identified by Docket ID number and title, by the following method:

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

    Instructions: All submissions received must include the agency name, Docket ID number and title for this Federal Register document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the Internet at http://www.regulations.gov as they are received without change, including any personal identifiers or contact information.

    DOD Clearance Officer: Mr. Frederick Licari.

    Written requests for copies of the information collection proposal should be sent to Mr. Licari at WHS/ESD Directives Division, 4800 Mark Center Drive, East Tower, Suite 03F09, Alexandria, VA 22350-3100.

    Dated: August 2, 2017. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense.
    [FR Doc. 2017-16567 Filed 8-4-17; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF DEFENSE Office of the Secretary [Transmittal No. 17-31] Arms Sales Notification AGENCY:

    Defense Security Cooperation Agency, Department of Defense.

    ACTION:

    Arms sales notice.

    SUMMARY:

    The Department of Defense is publishing the unclassified text of a section 36(b)(1) arms sales notification.

    FOR FURTHER INFORMATION CONTACT:

    Pamela Young, (703) 697-9107, [email protected] or Kathy Valadez, (703) 697-9217, [email protected]; DSCA/DSA-RAN.

    SUPPLEMENTARY INFORMATION:

    This 36(b)(1) arms sales notification is published to fulfill the requirements of section 155 of Public Law 104-164 dated July 21, 1996. The following is a copy of a letter to the Speaker of the House of Representatives, Transmittal 17-31 with attached Policy Justification.

    Dated: August 2, 2017. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense. BILLING CODE 5001-06-P EN07AU17.025 Transmittal No. 17-31 Notice of Proposed Issuance of Letter of Offer Pursuant to Section 36(b)(1) of the Arms Export Control Act, as amended

    (i) Prospective Purchaser: Government of Australia

    (ii) Total Estimated Value:

    Major Defense Equipment * $49 million Other $ 1 million Total $50 million

    (iii) Description and Quantity or Quantities of Articles or Services under Consideration for Purchase:

    Major Defense Equipment (MDE):

    Six thousand thirty (6,030) rounds of M865 120mm Target Practice Cone Stabilized Discarding Sabot-Tracer (TPCSDS-T) Tank Projectiles Eight thousand six hundred ten (8,610) rounds of M1002 120mm Target Practice Multipurpose Tracer (TPMP-T) Tank Projectiles

    Non-MDE includes: Also included are U.S. Government technical assistance, technical data, and other related elements of logistical and program support.

    (iv) Military Department: Army (XX-B-UJL)

    (v) Prior Related Cases, if any: AT-B-UGR

    (vi) Sales Commission, Fee, etc., Paid, Offered, or Agreed to be Paid: None

    (vii) Sensitivity of Technology Contained in the Defense Article or Defense Services Proposed to be Sold: None

    (viii) Date Report Delivered to Congress: July 10, 2017

    * As defined in Section 47(6) of the Arms Export Control Act.

    POLICY JUSTIFICATION Australia—120MM Tank Ammunition and Related Support Services

    The Government of Australia has requested the possible sale of six thousand thirty (6,030) rounds of M865 120mm Target Practice Cone Stabilized Discarding Sabot-Tracer (TPCSDS-T) Tank Projectiles and eight thousand six hundred ten (8,610) rounds of M1002 120mm Target Practice Multipurpose Tracer (TPMP-T) Tank Projectiles. Also included are U.S. Government technical services, technical data, and other related elements of logistical and program support. The total estimated program cost is $50 million.

    This sale will contribute to the foreign policy and national security of the United States by helping to improve the security of a major contributor to political stability, security, and economic development in the Western Pacific. Australia is an important Major non-NATO Ally and partner that contributes significantly to peacekeeping and humanitarian operations around the world. It is vital to the U.S. national interest to assist our ally in developing and maintaining a strong and ready self-defense capability.

    The proposed sale of 120mm tank ammunition will improve Australia's capability to meet out-year operational readiness and training requirements. Australia will use this ammunition to help sustain necessary training levels for its tank operators. Australia will have no difficulty absorbing this equipment into its armed forces.

    The proposed sale of this equipment and support will not alter the basic military balance in the region.

    This requirement will be provided from U.S. Army inventory. There are no known offset agreements proposed in connection with this potential sale.

    Implementation of this proposed sale will not require the assignment of any additional U.S. or contractor representatives to Australia.

    There will be no adverse impact on U.S. defense readiness as a result of this proposed sale.

    [FR Doc. 2017-16603 Filed 8-4-17; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF DEFENSE Office of the Secretary [Transmittal No. 17-23] Arms Sales Notification AGENCY:

    Defense Security Cooperation Agency, Department of Defense.

    ACTION:

    Arms sales notice.

    SUMMARY:

    The Department of Defense is publishing the unclassified text of a section 36(b)(1) arms sales notification.

    FOR FURTHER INFORMATION CONTACT:

    Pamela Young, (703) 697-9107, [email protected] or Kathy Valadez, (703) 697-9217, kathy.a.vala[email protected]; DSCA/DSA-RAN.

    SUPPLEMENTARY INFORMATION:

    This 36(b)(1) arms sales notification is published to fulfill the requirements of section 155 of Public Law 104-164 dated July 21, 1996. The following is a copy of a letter to the Speaker of the House of Representatives, Transmittal 17-23 with attached Policy Justification and Sensitivity of Technology.

    Dated: August 2, 2017. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense. EN07AU17.024 BILLING CODE 5001-06-C Transmittal No. 17-23 Notice of Proposed Issuance of Letter of Offer Pursuant to Section 36(b)(1) of the Arms Export Control Act, as amended

    (i) Prospective Purchaser: United Kingdom

    (ii) Total Estimated Value:

    Major Defense Equipment* $887 million Other $148 million Total $1.035 billion

    (iii) Description and Quantity or Quantities of Articles or Services under Consideration for Purchase:

    Major Defense Equipment (MDE): Two thousand seven hundred forty-seven (2,747) Joint Light Tactical Vehicles (JLTV)

    Non-MDE: Also included with this request are baseline integration kits, basic issue item kits, B-kit armor, engine arctic kits, fording kits, run-flat kits, spare tire kits, silent watch kits, power expansion kits cargo cover kits, maintainer and operator training, U.S. government technical assistance and logistics support services, and other related elements of logistics and program support.

    (iv) Military Department: Army

    (v) Prior Related Cases, if any: None

    (vi) Sales Commission, Fee, etc., Paid, Offered, or Agreed to be Paid: None

    (vii) Sensitivity of Technology Contained in the Defense Article or Defense Services Proposed to be Sold: See Attached Annex

    (viii) Date Report Delivered to Congress: July 10, 2017

    *As defined in Section 47(6) of the Arms Export Control Act.

    POLICY JUSTIFICATION United Kingdom—Joint Light Tactical Vehicles (JLTV) and Accessories

    The Government of the United Kingdom (UK) has requested a possible sale of up to two thousand seven hundred forty-seven (2,747) Joint Light Tactical Vehicles (JLTV). This possible sale also includes baseline integration kits, basic issue item kits, B-kit armor, engine arctic kits, fording kits, run-flat kits, spare tire kits, silent watch kits, power expansion kits cargo cover kits, maintainer and operator training, U.S. government technical assistance and logistics support services, and other related elements of logistics and program support. Total estimated cost is $1.035 billion.

    This proposed sale supports the foreign policy and national security policies of the United States by helping to improve the security of a NATO ally which has been, and continues to be, an important partner on critical foreign policy and defense issues.

    The proposed sale will help improve the UK's Light Tactical Vehicle Fleet and enhance its ability to meet current and future threats. The UK will have no difficulty absorbing this equipment into its armed forces.

    The proposed sale will not alter the basic military balance in the region.

    The principal contractor of this sale will be Oshkosh Defense, LLC, Oshkosh, Wisconsin. The procured items will require minimum contractor support until the foreign customer can eventually transition to internal organic support. There is no known offset agreement associated with this proposed sale.

    There will be no adverse impact on U.S. defense readiness as a result of this proposed sale.

    Transmittal No. 17-23 Notice of Proposed Issuance of Letter of Offer Pursuant to Section 36(b)(1) of the Arms Export Control Act, as amended Annex Item No. vii

    (vii) Sensitivity of Technology:

    1. This sale will involve the release of sensitive technology to the Government of the United Kingdom. The Joint Light Tactical Vehicle platform is classified as SECRET. The Joint Light Tactical Vehicle fleet will incorporate ballistic armor kits for protection from improvised explosive devices.

    2. Sensitive and/or classified (up to SECRET) elements of the proposed Joint Light Tactical Vehicle include hardware and accessories, components and associated software: baseline integration kits, basic issue items, ballistic-kit armor, engine arctic kits, fording kits, run-flat kits, silent watch energy kits, power expansion kits and cargo covering kits.

    3. A determination has been made that the United Kingdom can provide substantially the same degree of protection for this technology as the U.S. Government. This proposed sale is necessary in furtherance of U.S. foreign policy and national security objectives outlined in the Policy Justification.

    4. All defense articles and services listed in this transmittal have been authorized for release and export to the Government of the UK.

    [FR Doc. 2017-16595 Filed 8-4-17; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF DEFENSE Department of the Army, U.S. Army Corps of Engineers Notice of Availability of The Great Lakes and Mississippi River Interbasin Study—Brandon Road Draft Integrated Feasibility Study and Environmental Impact Statement—Will County, Illinois AGENCY:

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

    ACTION:

    Notice of availability.

    SUMMARY:

    The U.S. Army Corps of Engineers (USACE) has posted The Great Lakes and Mississippi River Interbasin Study—Brandon Road Draft Integrated Feasibility Study and Environmental Impact Statement—Will County, Illinois (GLMRIS-Brandon Road Report) on http://glmris.anl.gov. The GLMRIS—Brandon Road Report presents a plan to address the transfer of aquatic nuisance species (ANS) from the Mississippi River Basin to the Great Lakes Basin through an aquatic connection in the Chicago Area Waterway System. The purpose of this study is to evaluate structural and nonstructural options and technologies near the Brandon Road Lock and Dam to prevent the upstream transfer of ANS. USACE analyzed and evaluated available controls to address ANS of concern and formulated alternatives specifically for the Brandon Road site. USACE also evaluated the potential impacts of the alternatives and ways to minimize such impacts.

    USACE conducted the GLMRIS-Brandon Road Study in consultation with other Federal agencies, Native American tribes, state agencies, local governments, non-governmental organizations, and industry.

    DATES:

    There will be a 45-day public review period for comments on this document beginning Monday August 7, 2017, through Thursday September 21, 2017. Comments will be accepted through the GLMRIS project Web site at http://glmris.anl.gov, by letter and at public meetings. Public meeting dates and locations are to be determined. See SUPPLEMENTARY INFORMATION section for instructions on how to submit public comments.

    FOR FURTHER INFORMATION CONTACT:

    For further information and/or questions about GLMRIS-Brandon Road, please contact Andrew Leichty, Program Manager, by mail: U.S. Army Corps of Engineers, Rock Island District, Clock Tower Building (ATTN: Leichty), P.O. Box 2004, Rock Island, IL 61204-2004, by phone: 309-794-5399; or by email: [email protected]

    For media inquiries, please contact Allen Marshall, District Spokesperson, by mail: U.S. Army Corps of Engineers, Rock Island District, Clock Tower Building (ATTN: Marshall), P.O. Box 2004, Rock Island, IL 61204-2004, by phone: 309-794-5204; or by email: [email protected]

    SUPPLEMENTARY INFORMATION:

    1. Background

    The GLMRIS authority directed USACE to identify the range of options and technologies available to prevent the spread of ANS between the Great Lakes and Mississippi River Basins through the Chicago Sanitary and Ship Canal and other aquatic pathways. The goal of the GLMRIS-Brandon Road Study is to prevent the upstream transfer of ANS while minimizing impacts to existing waterways uses and users. USACE conducted the GLMRIS-Brandon Road Study in consultation with other Federal agencies, Native American tribes, state agencies, local governments, non-governmental organizations, and industry.

    2. The GLMRIS-Brandon Road Report

    The GLMRIS-Brandon Road Report identified six potential alternatives including no new action (continuing current efforts), a nonstructural alternative, three technology alternatives using an electric barrier and/or complex noise, and lock closure. The effectiveness of these alternatives was considered against the three different modes of ANS transport—swimming, floating, and hitchhiking. Selection of the Tentatively Selected Plan (TSP) required careful evaluation of each alternative's 1. reduction in the probability of establishment in the Great Lakes Basin; 2. life safety risk; 3. system performance robustness; and 4. costs, which include construction, mitigation, operation and maintenance, repair, replacement and rehabilitation, and navigation impacts. The evaluation also included careful consideration of cost effectiveness and incremental cost analyses; significance of the Great Lakes Basin ecosystem; and acceptability, completeness, efficiency, and effectiveness. The GLMRIS-Brandon Road Report identifies potential adverse impacts that alternatives may have on existing uses and users of the waterways. Based on the results of the evaluation and comparison of the alternatives, the TSP is the Technology Alternative—Complex Noise with Electric Barrier, which includes the following measures: Nonstructural measures, complex noise, water jets, engineered channel, electric barrier, flushing lock, boat ramps, and mooring area.

    3. Public Participation

    USACE will accept comments related to the GLMRIS-Brandon Road Report until September 21, 2017. Comments may be submitted in the following ways:

    GLMRIS Project Web site: Use the web comment function found at http://glmris.anl.gov.

    Mail: Send comments to U.S. Army Corps of Engineers, Chicago District, ATTN: GLMRIS-Brandon Road Comments, 231 S. LaSalle St., Suite 1500, Chicago, IL 60604. Comments must be postmarked by September 21, 2017.

    Public Meetings: Public meeting dates, times and locations are to be determined; USACE asks those wanting to make oral comments to register on the GLMRIS project Web site at http://glmris.anl.gov. Each individual wishing to make oral comments shall be given three (3) minutes, and a stenographer will document oral comments.

    Public meetings will begin with a brief presentation regarding the study and the formulated alternatives followed by an oral comment period. During each meeting, USACE personnel will also collect written comments on comment cards. Additional information about public meetings including dates, times and locations will be posted on the GLMRIS project Web site at http://glmris.anl.gov as soon as that information is available.

    Comments, including the names and addresses of those that comment, received during the comment period will be posted on the GLMRIS project Web site. Comments submitted anonymously will be accepted, considered, and posted. Commenters may indicate that they do not wish to have their name or other personal information made available on the Web site. However, USACE cannot guarantee that information withheld from the Web site will be maintained as confidential. Persons requesting confidentially should be aware that, under the Freedom of Information Act, confidentiality may be granted in only limited circumstances.

    4. Authority

    This action is being undertaken pursuant to the Water Resources and Development Act of 2007, Section 3061(d), Public Law 110-114, and the National Environmental Policy Act of 1969 (NEPA), 42 U.S.C. 4321, et seq., as amended.

    Dated: July 28, 2017. Dennis W. Hamilton, Chief, Programs and Project Management Division.
    [FR Doc. 2017-16597 Filed 8-4-17; 8:45 am] BILLING CODE 3720-58-P
    DEPARTMENT OF EDUCATION [Docket No.: ED-2017-ICCD-0075] Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; U.S. Department of Education Supplemental Information for the SF-424 Form AGENCY:

    Office of the Secretary (OS), Department of Education (ED).

    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 September 6, 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-0075. 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 216-32, Washington, DC 20202-4537.

    FOR FURTHER INFORMATION CONTACT:

    For specific questions related to collection activities, please contact Alfreida Pettiford, 202-245-6110.

    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: U.S. Department of Education Supplemental Information for the SF-424 form.

    OMB Control Number: 1894-0007.

    Type of Review: An extension of an existing information collection.

    Respondents/Affected Public: Private Sector.

    Total Estimated Number of Annual Responses: 8,078.

    Total Estimated Number of Annual Burden Hours: 2,666.

    Abstract: The U.S. Department of Education Supplemental Information form for the SF-424 is used together with the SF-424, Application for Federal Assistance. ED made a policy decision to switch to the SF-424 in keeping with Federal-wide forms standardization and streamlining efforts, especially with widespread agency use of Grants.gov.

    The questions on this form deal with the following areas: Project Director identifying and contact information; Novice Applicants; and Human Subjects Research. The ED supplemental information form could be used with any of the SF-424 forms in the SF-424 forms family, as applicable.

    Dated: August 2, 2017. Stephanie Valentine, Acting Director, Information Collection Clearance Division, Office of the Chief Privacy Officer, Office of Management.
    [FR Doc. 2017-16542 Filed 8-4-17; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF ENERGY Office of Energy Efficiency and Renewable Energy Notice of Availability of Guidance and Application for Hydroelectric Incentive Program AGENCY:

    Water Power Technologies Office, Office of Energy Efficiency and Renewable Energy, Department of Energy.

    ACTION:

    Notice of availability of guidance and open application period.

    SUMMARY:

    The U.S. Department of Energy (DOE) gives notice of updated guidance for the Energy Policy Act of 2005 program. The guidance describes the hydroelectric incentive payment requirements and explains the type of information that owners or authorized operators of qualified hydroelectric facilities must provide DOE when applying for hydroelectric incentive payments. This incentive is available for electric energy generated and sold for a specified 10-year period as authorized under the Energy Policy Act of 2005. In Congressional appropriations for Federal fiscal year 2017, DOE received funds to support this hydroelectric incentive program. At this time, DOE is only accepting applications from owners and authorized operators of qualified hydroelectric facilities for hydroelectricity generated and sold in calendar year 2016.

    DATES:

    DOE is currently accepting applications from August 7, 2017 through September 6, 2017. Applications must be sent to [email protected] by midnight EDT, September 6, 2017, or they will not be considered timely filed for calendar year 2016 incentive payments.

    ADDRESSES:

    DOE's guidance is available at: https://energy.gov/eere/water/downloads/federal-register-notice-epact-2005-section-242-hydroelectric-incentive-0. Written correspondence may be sent to the Office of Energy Efficiency and Renewable Energy (EE-4W), by email at [email protected].

    FOR FURTHER INFORMATION CONTACT:

    Requests for additional information should be directed to Mr. Timothy Welch, Office of Energy Efficiency and Renewable Energy (EE-4W), U.S. Department of Energy, 1000 Independence Avenue SW., Washington, DC 20585-0121, (202) 586-7055 or by email at [email protected]. Electronic communications are recommended for correspondence and required for submission of application information.

    SUPPLEMENTARY INFORMATION:

    In the Energy Policy Act of 2005 (EPAct 2005; Pub. L. 109-58), Congress established a new program to support the expansion of hydropower energy development at existing dams and impoundments through an incentive payment procedure. Under Section 242 of EPAct 2005, the Secretary of Energy is directed to provide incentive payments to the owner or authorized operator of qualified hydroelectric facilities for energy generated and sold by a qualified hydroelectric facility for a specified 10-year period (See 42 U.S.C. 15881). The Consolidated Appropriations Act, 2017 authorized funding for the Section 242 program for conventional hydropower under EPAct 2005. In FY2017 DOE allocated $6.6M for this purpose.

    Recently DOE made a minor update to its Guidance for the Energy Policy Act of 2005 Section 242. The final guidance is available at: https://energy.gov/eere/water/downloads/federal-register-notice-epact-2005-section-242-hydroelectric-incentive-0. Each application will be reviewed based on the Guidance. DOE has updated its Guidance by requesting a statement from the owner or authorized operator indicating what the incentive has been used for in previous years and, if awarded, what the incentive will be used for in the upcoming year. The response will not affect the eligibility decision or the amount of the incentive to be received. DOE notes that applicants that received incentive payments for prior calendar years must submit a full application addressing all eligibility requirements for hydroelectricity generated and sold in calendar year 2016. As authorized under Section 242 of EPAct 2005, and as explained in the Guidance, DOE also notes that it will only accept applications from qualified hydroelectric facilities that began operations at an existing dam or conduit during the inclusive period beginning October 1, 2005, and ending on September 30, 2015. Therefore, although DOE is accepting applications for full calendar year 2016 production, the qualified hydroelectric facility must have begun operations starting October 1, 2005, through September 30, 2015, for DOE to consider the application.

    When submitting information to DOE for Section 242 program, it is recommended that applicants carefully read and review the completed content of the Guidance for this process. When reviewing applications, DOE may corroborate the information provided with information that DOE finds through FERC e-filings, contact with power off-taker, and other due diligence measure carried out by reviewing officials. DOE may require the applicant to conduct and submit an independent audit at its own expense, or DOE may conduct an audit to verify the number of kilowatt-hours claimed to have been generated and sold by the qualified hydroelectric facility and for which an incentive payment has been requested or made.

    Issued in Washington, DC, on August 1, 2017. Timothy Unruh, Deputy Assistant Secretary for Renewable Power, Energy Efficiency and Renewable Energy.
    [FR Doc. 2017-16559 Filed 8-4-17; 8:45 am] BILLING CODE P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. ER17-2201-000] Exelon FitzPatrick, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization

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

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

    Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is August 21, 2017.

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

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

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

    Dated: August 1, 2017. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2017-16547 Filed 8-4-17; 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: EC17-145-000.

    Applicants: Cimarron Windpower II, LLC.

    Description: Application for Authorization Under Section 203 of the Federal Power Act of Cimarron Windpower II, LLC.

    Filed Date: 8/1/17.

    Accession Number: 20170801-5117.

    Comments Due: 5 p.m. ET 8/22/17.

    Docket Numbers: EC17-146-000.

    Applicants: Dighton Power, LLC, Milford Power, LLC, Marco DM Holdings, L.L.C.

    Description: Joint Application for Authorization under Section 203 of the Federal Power Act of Dighton Power, LLC, et al.

    Filed Date: 8/1/17.

    Accession Number: 20170801-5176.

    Comments Due: 5 p.m. ET 8/22/17.

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

    Docket Numbers: ER17-2214-000.

    Applicants: Great Valley Solar 2, LLC.

    Description: Initial rate filing: Great Valley Solar 2, LLC Certificate of Concurrence to Shared Facilities Agmt to be effective 10/1/2017.

    Filed Date: 8/1/17.

    Accession Number: 20170801-5106.

    Comments Due: 5 p.m. ET 8/22/17.

    Docket Numbers: ER17-2215-000.

    Applicants: Great Valley Solar 2, LLC.

    Description: Initial rate filing: Great Valley Solar 2, LLC Certificate of Concurrence to LGIA Co-Tenancy Agmt to be effective 10/1/2017.

    Filed Date: 8/1/17.

    Accession Number: 20170801-5108.

    Comments Due: 5 p.m. ET 8/22/17.

    Docket Numbers: ER17-2216-000.

    Applicants: Southwest Power Pool, Inc.

    Description: § 205(d) Rate Filing: 2014 Southwestern Power Administration Amendatory Agreement Seventh Extension to be effective 10/1/2017.

    Filed Date: 8/1/17.

    Accession Number: 20170801-5157.

    Comments Due: 5 p.m. ET 8/22/17.

    Docket Numbers: ER17-2217-000.

    Applicants: PJM Interconnection, L.L.C.

    Description: Tariff Cancellation: Notice of Cancellation of Original Service Agreement No. 4695, Queue No. AB2-061 to be effective 7/11/2017.

    Filed Date: 8/1/17.

    Accession Number: 20170801-5172.

    Comments Due: 5 p.m. ET 8/22/17.

    Take notice that the Commission received the following foreign utility company status filings:

    Docket Numbers: FC17-5-000.

    Applicants: Aspa Energias Renovables, S.L.U.

    Description: Self-Certification of FC of Aspa Energias Renovables, S.L.U., et al.

    Filed Date: 8/1/17.

    Accession Number: 20170801-5148.

    Comments Due: 5 p.m. ET 8/22/17.

    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: August 1, 2017. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2017-16546 Filed 8-4-17; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. ID-8260-000] Dosch, Theodore A.; Notice of Filing

    Take notice that on August 1, 2017, Theodore A. Dosch, submitted for filing an application for authority to hold interlocking positions, pursuant to section 305(b) of the Federal Power Act, 16 U.S.C. 825d(b), and Part 45 of the Federal Energy Regulatory Commission's (Commission) Rules of Practice and Procedure, 18 CFR part 45.

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

    The Commission encourages electronic submission of protests and interventions in lieu of paper using the eFiling link at http://www.ferc.gov. Persons unable to file electronically should submit an original and 5 copies of the protest or intervention to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.

    This filing is accessible on-line at http://www.ferc.gov, using the eLibrary link and is available for 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 August 22, 2017.

    Dated: August 1, 2017. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2017-16548 Filed 8-4-17; 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: EC17-143-000.

    Applicants: Great Valley Solar 1, LLC, Great Valley Solar 2, LLC.

    Description: Application for Authorization of Transaction Pursuant to Section 203 of the Federal Power Act of Great Valley Solar 1, LLC, et al.

    Filed Date: 7/31/17.

    Accession Number: 20170731-5316.

    Comments Due: 5 p.m. ET 8/21/17.

    Docket Numbers: EC17-144-000.

    Applicants: Noble Americas Gas & Power Corp., Mercuria Energy America, Inc.

    Description: Joint Application for Authorization under Section 203 of the Federal Power Act of Noble Americas Gas & Power Corp., et al.

    Filed Date: 7/31/17.

    Accession Number: 20170731-5318.

    Comments Due: 5 p.m. ET 8/21/17.

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

    Docket Numbers: ER10-2906-010; ER10-2908-010; ER10-2910-010; ER11-4666-003; ER11-4667-003; ER12-295-002; ER11-4669-004; ER11-4670-004; ER12-709-003.

    Applicants: Morgan Stanley Capitol Group Inc., MS Solar Solutions Corp., Power Contract Financing II, L.L.C., NaturEner Glacier Wind Energy 1, LLC, NaturEner Glacier Wind Energy 2, LLC, NaturEner Rim Rock Wind Energy, LLC, Naturener Montana Wind Energy, LLC, NaturEner Power Watch, LLC, NaturEner Wind Watch, LLC.

    Description: Notice of Change in Status of the Morgan Stanley Public Utilities, et al.

    Filed Date: 7/31/17.

    Accession Number: 20170731-5325.

    Comments Due: 5 p.m. ET 8/21/17.

    Docket Numbers: ER17-1357-001.

    Applicants: Duke Energy Progress, LLC, Duke Energy Carolinas, LLC.

    Description: Report Filing: Errata to June 27 Filing (Loss Factors) to be effective N/A.

    Filed Date: 7/31/17.

    Accession Number: 20170731-5138.

    Comments Due: 5 p.m. ET 8/21/17.

    Docket Numbers: ER17-2201-000.

    Applicants: Exelon FitzPatrick, LLC.

    Description: Baseline eTariff Filing: Exelon Fitzpatrick MBR Application to be effective 9/29/2017.

    Filed Date: 7/31/17.

    Accession Number: 20170731-5242.

    Comments Due: 5 p.m. ET 8/21/17.

    Docket Numbers: ER17-2202-000.

    Applicants: PJM Interconnection, L.L.C.

    Description: § 205(d) Rate Filing: Queue Nos. Y3-051/Z1-058/Z1-059/Z2-002, Third Rev. Service Agreement No. 3669 to be effective 8/29/2016.

    Filed Date: 7/31/17.

    Accession Number: 20170731-5244.

    Comments Due: 5 p.m. ET 8/21/17.

    Docket Numbers: ER17-2203-000.

    Applicants: Arizona Public Service Company.

    Description: § 205(d) Rate Filing: Mead Service Agreement Nos. 218 and 335 to be effective 7/1/2017.

    Filed Date: 7/31/17.

    Accession Number: 20170731-5290.

    Comments Due: 5 p.m. ET 8/21/17.

    Docket Numbers: ER17-2204-000.

    Applicants: Pacific Gas and Electric Company.

    Description: § 205(d) Rate Filing: 7-31-17 Unexecuted Agreement, City and County of San Francisco WDT (SA 275) to be effective 8/1/2017.

    Filed Date: 7/31/17.

    Accession Number: 20170731-5293.

    Comments Due: 5 p.m. ET 8/21/17.

    Docket Numbers: ER17-2205-000.

    Applicants: PJM Interconnection, L.L.C.

    Description: § 205(d) Rate Filing: Interconnection Service Agreement No. 4761; Queue NQ147 to be effective 8/1/2017.

    Filed Date: 7/31/17.

    Accession Number: 20170731-5299.

    Comments Due: 5 p.m. ET 8/21/17.

    Docket Numbers: ER17-2206-000.

    Applicants: Alabama Power Company.

    Description: § 205(d) Rate Filing: SWE (Hartford) NITSA Amendment Filing to be effective 7/1/2017.

    Filed Date: 7/31/17.

    Accession Number: 20170731-5310.

    Comments Due: 5 p.m. ET 8/21/17.

    Docket Numbers: ER17-2207-000.

    Applicants: Entergy Texas, Inc.

    Description: § 205(d) Rate Filing: Coordination Services Agreement to be effective 8/1/2017.

    Filed Date: 8/1/17.

    Accession Number: 20170801-5004.

    Comments Due: 5 p.m. ET 8/22/17.

    Docket Numbers: ER17-2208-000.

    Applicants: Entergy Arkansas, Inc., Entergy Louisiana, LLC, Entergy Mississippi, Inc., Entergy New Orleans, Inc., Entergy Texas, Inc.

    Description: § 205(d) Rate Filing: Entergy OpCos Reactive Power Update to be effective 8/1/2017.

    Filed Date: 8/1/17.

    Accession Number: 20170801-5005.

    Comments Due: 5 p.m. ET 8/22/17.

    Docket Numbers: ER17-2209-000.

    Applicants: Duke Energy Progress, LLC.

    Description: § 205(d) Rate Filing: Filing of Vepco Faciliities Agreement RS 203 to be effective 10/2/2017.

    Filed Date: 8/1/17.

    Accession Number: 20170801-5025.

    Comments Due: 5 p.m. ET 8/22/17.

    Docket Numbers: ER17-2209-000.

    Applicants: Duke Energy Progress, LLC.

    Description: Report Filing: Refund Report Vepco Facilities Agreement to be effective N/A.

    Filed Date: 8/1/17.

    Accession Number: 20170801-5026.

    Comments Due: 5 p.m. ET 8/22/17.

    Docket Numbers: ER17-2210-000.

    Applicants: Duke Energy Carolinas, LLC.

    Description: § 205(d) Rate Filing: SCE&G Metering Agreement RS 349 to be effective 10/2/2017.

    Filed Date: 8/1/17.

    Accession Number: 20170801-5046.

    Comments Due: 5 p.m. ET 8/22/17.

    Docket Numbers: ER17-2211-000.

    Applicants: Duke Energy Ohio, Inc.

    Description: § 205(d) Rate Filing: Hamilton Joint Use Pole Agreement to be effective 10/2/2017.

    Filed Date: 8/1/17.

    Accession Number: 20170801-5071.

    Comments Due: 5 p.m. ET 8/22/17.

    Docket Numbers: ER17-2212-000.

    Applicants: Duke Energy Ohio, Inc.

    Description: § 205(d) Rate Filing: Bio Energy GIA Filing to be effective 10/2/2017.

    Filed Date: 8/1/17.

    Accession Number: 20170801-5093.

    Comments Due: 5 p.m. ET 8/22/17.

    Docket Numbers: ER17-2212-000.

    Applicants: Duke Energy Ohio, Inc.

    Description: Report Filing: Bio Energy Refund Report to be effective N/A.

    Filed Date: 8/1/17.

    Accession Number: 20170801-5098.

    Comments Due: 5 p.m. ET 8/22/17.

    Docket Numbers: ER17-2213-000.

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

    Description: § 205(d) Rate Filing: NMPC 205 CRA No. 2357 with NYSEG for Silver Creek Substation to be effective 5/3/2017.

    Filed Date: 8/1/17.

    Accession Number: 20170801-5097.

    Comments Due: 5 p.m. ET 8/22/17.

    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: August 1, 2017. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2017-16545 Filed 8-4-17; 8:45 am] BILLING CODE 6717-01-P
    FEDERAL COMMUNICATIONS COMMISSION [OMB 3060-XXXX] Information Collection Being Reviewed by the Federal Communications Commission AGENCY:

    Federal Communications Commission.

    ACTION:

    Notice and request for comments.

    SUMMARY:

    As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act of 1995 (PRA), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.

    The FCC may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.

    DATES:

    Written comments should be submitted on or before October 6, 2017. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contacts below as soon as possible.

    ADDRESSES:

    Direct all PRA comments to Cathy Williams, FCC, via email: [email protected] and to [email protected]

    FOR FURTHER INFORMATION CONTACT:

    For additional information about the information collection, contact Cathy Williams at (202) 418-2918.

    SUPPLEMENTARY INFORMATION:

    As part of its continuing effort to reduce paperwork burdens, and as required by the PRA, 44 U.S.C. 3501-3520, the FCC invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.

    OMB Control Number: 3060-XXXX.

    Title: Transition from TTY to Real-Time Text Technology, CG Docket No. 16-145 and GN Docket No. 15-178.

    Form Number: N/A.

    Type of Review: New collection.

    Respondents: Businesses or other for-profit entities.

    Number of Respondents and Responses: 967 respondents; 5,557 responses.

    Estimated Time per Response: 0.2 hours (12 minutes) to 60 hours.

    Frequency of Response: Annual, ongoing, one-time, and semiannual reporting requirements; recordkeeping requirement.

    Obligation To Respond: Required to obtain or retain benefit. The statutory authority can be found at sections 4(i), 225, 255, 301, 303(r), 316, 403, 715, and 716 of the Communications Act of 1934, as amended, and section 106 of the Twenty-First Century Communications and Video Accessibility Act of 2010, 47 U.S.C. 154(i), 225, 255, 301, 303(r), 316, 403, 615c, 616, 617; Public Law 111-260, 106, 124 Stat. 2751, 2763 (2010).

    Total Annual Burden: 127,360 hours.

    Total Annual Cost: No cost.

    Nature and Extent of Confidentiality: There is no need for confidentiality with this collection of information.

    Privacy Impact Assessment: This information collection does not affect individuals or households; therefore, the Privacy Act is not impacted.

    Needs and Uses: TTY technology provides the primary means for people with disabilities to send and receive text communications over the public switched telephone network (PSTN). Changes to communications networks, particularly ongoing technology transitions from circuit switched to IP-based networks and from copper to wireless and fiber infrastructure, have affected the quality and utility of TTY technology, prompting discussions on transitioning to an alternative advanced communications technology for text communications. Accordingly, on December 16, 2016, the Commission released Transition from TTY to Real-Time Text Technology, Report and Order, document FCC 16-169, 82 FR 7699, January 23, 2017, amending its rules that govern the obligations of wireless service providers and manufacturers to support TTY technology to permit such providers and manufacturers to provide support for real-time text (RTT) over wireless IP-based networks to facilitate an effective and seamless transition to RTT in lieu of continuing to support TTY technology.

    In document FCC 16-169, the Commission adopted measures requiring the following:

    (a) Each wireless provider and manufacturer that voluntarily transitions from TTY technology to RTT over wireless IP-based networks and services is encouraged to develop consumer and education efforts that include (1) the development and dissemination of educational materials that contain information pertinent to the nature, purpose, and timelines of the RTT transition; (2) Internet postings, in an accessible format, of information about the TTY to RTT transition on the Web sites of covered entities; (3) the creation of a telephone hotline and an online interactive and accessible service that can answer consumer questions about RTT; and (4) appropriate training of staff to effectively respond to consumer questions. All consumer outreach and education should be provided in accessible formats including, but not limited to, large print, Braille, videos in American Sign Language and that are captioned and video described, emails to consumers who have opted to receive notices in this manner, and printed materials. Service providers and manufacturers are also encouraged to coordinate with consumer, public safety, and industry stakeholders to develop and distribute education and outreach materials. The information will inform consumers of alternative accessible technology available to replace TTY technology that may no longer be available to the consumer through their provider or on their device.

    (b) Each wireless provider that requested or will request and receives a waiver of the requirement to support TTY technology over wireless IP-based networks and services must apprise their customers, through effective and accessible channels of communication, that (1) until TTY is sunset, TTY technology will not be supported for calls to 911 services over IP-based wireless services, and (2) there are alternative PSTN-based and IP-based accessibility solutions for people with disabilities to reach 911 services. These notices must be developed in coordination with PSAPs and national consumer organizations, and include a listing of text-based alternatives to 911, including, but not limited to, TTY capability over the PSTN, various forms of PSTN-based and IP-based TRS, and text-to-911 (where available). The notices will inform consumers on the loss of the use of TTY for completing 911 calls over the provider's network and alert them to alternatives service for which TTY may be used.

    (c) Once every six months, each wireless provider that requests and receives a waiver of the requirement to support TTY technology must file a report with the Commission and inform its customers regarding its progress toward and the status of the availability of new IP-based accessibility solutions. Such reports must include (1) information on the interoperability of the provider's selected accessibility solution with the technologies deployed or to be deployed by other carriers and service providers, (2) the backward compatibility of such solution with TTYs, (3) a showing of the provider's efforts to ensure delivery of 911 calls to the appropriate PSAP, (4) a description of any obstacles incurred towards achieving interoperability and steps taken to overcome such obstacles, and (5) an estimated timetable for the deployment of accessibility solutions. The information will inform consumers of the progress towards the availability of alternative accessible means to replace TTY, and the Commission will be able to evaluate the reports to determine if any changes to the waivers are warranted or of any impediments to progress that it may be in a position to resolve.

    Federal Communications Commission. Marlene H. Dortch, <E T="03">Secretary.</E>
    [FR Doc. 2017-16566 Filed 8-4-17; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL COMMUNICATIONS COMMISSION [OMB 3060-1015] Information Collection Being Reviewed by the Federal Communications Commission Under Delegated Authority AGENCY:

    Federal Communications Commission.

    ACTION:

    Notice and request for comments.

    SUMMARY:

    As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995, the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid Office of Management and Budget (OMB) control number.

    DATES:

    Written PRA comments should be submitted on or before October 6, 2017. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.

    ADDRESSES:

    Direct all PRA comments to Nicole Ongele, FCC, via email [email protected] and to [email protected]

    FOR FURTHER INFORMATION CONTACT:

    For additional information about the information collection, contact Nicole Ongele at (202) 418-2991.

    SUPPLEMENTARY INFORMATION:

    As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.

    OMB Control Number: 3060-1015.

    Title: Section 15.525—Ultra Wideband Transmission Systems Operating Under Part 15.

    Form Number: N/A.

    Type of Review: Extension of a currently approved collection.

    Respondents: Business or other for-profit; Not-for-profit institutions.

    Number of Respondents and Responses: 50 respondents; 50 responses.

    Estimated Time per Response: 1 hour.

    Frequency of Response: One-time, on occasion reporting requirements; and third party disclosure requirement.

    Obligation To Respond: Required to obtain or retain benefits. 47 U.S.C. 154, 302a, 303, 304, 307, 336, 544a. and 549.

    Total Annual Burden: 50 hours.

    Total Annual Cost: $2,500.

    Privacy Impact Assessment: No impact(s).

    Nature and Extent of Confidentiality: There is no need for confidentiality.

    Needs and Uses: This collection will be submitted as an extension after this 60 day comment period to the Office of Management and Budget (OMB) in order to obtain the full three year clearance. The Commission rules in 47 CFR part 15, § 15.525 requires operators of the Ultra Wideband (UWB) imaging systems to coordinate with other Federal agencies via the FCC and to obtain approval before the UWB equipment may be used. Initial operation in a particular area may not commence until the information has been sent to the Commission and no prior approval is required. The information will be used to coordinate the operation of the Ultra Wideband transmission systems in order to avoid interference with sensitive U.S. government radio systems. The UWB operators will be required to provide name, address and other pertinent contact information of the user, the desired geographical area of operation, and the FCC ID number, and other nomenclature of the UWB device. This information will be collected by the Commission and forwarded to the National Telecommunications and Information Administration (NTIA) under the U.S. Department of Commerce. This information collection is essential to controlling potential interference to Federal radio communications. Since initial operation in a particular area does not require approval from the FCC to operate the equipment.

    Federal Communications Commission. Marlene H. Dortch, Secretary, Office of the Secretary.
    [FR Doc. 2017-16565 Filed 8-4-17; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL COMMUNICATIONS COMMISSION [OMB 3060-0906 and 3060-xxxx] Information Collections Being Submitted for Review and Approval to the Office of Management and Budget AGENCY:

    Federal Communications Commission.

    ACTION:

    Notice and request for comments.

    SUMMARY:

    As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995, the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.

    The Commission may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.

    DATES:

    Written comments should be submitted on or before September 6, 2017. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contacts listed below as soon as possible.

    ADDRESSES:

    Direct all PRA comments to Nicholas A. Fraser, OMB, via email [email protected]; and to Cathy Williams, FCC, via email [email protected] and to [email protected] Include in the comments the OMB control number as shown in the SUPPLEMENTARY INFORMATION below.

    FOR FURTHER INFORMATION CONTACT:

    For additional information or copies of the information collection, contact Cathy Williams at (202) 418-2918. To view a copy of this information collection request (ICR) submitted to OMB: (1) Go to the Web page http://www.reginfo.gov/public/do/PRAMain, (2) look for the section of the Web page called “Currently Under Review,” (3) click on the downward-pointing arrow in the “Select Agency” box below the “Currently Under Review” heading, (4) select “Federal Communications Commission” from the list of agencies presented in the “Select Agency” box, (5) click the “Submit” button to the right of the “Select Agency” box, (6) when the list of FCC ICRs currently under review appears, look for the OMB control number of this ICR and then click on the ICR Reference Number. A copy of the FCC submission to OMB will be displayed.

    SUPPLEMENTARY INFORMATION:

    As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.

    OMB Control Number: 3060-0906.

    Title: Annual DTV Ancillary/Supplemental Services Report for DTV Stations, FCC Form 317; 47 CFR 73.624(g).

    Form Number: FCC Form 317.

    Type of Review: Extension of a currently approved collection.

    Respondents: Business or other for-profit entities; Not-for-profit institutions.

    Number of Respondents and Responses: 9,391 respondents, 18,782 responses.

    Frequency of Response: Recordkeeping requirement, annual reporting requirement.

    Obligation To Respond: Required to obtain benefits—Statutory authority for this collection of information is contained in Sections 154(i), 303, 336 and 403 of the Communications Act of 1934, as amended.

    Estimated Time per Response: 2-4 hours.

    Total Annual Burden: 56,346 hours.

    Total Annual Cost: $1,408,650.

    Nature and Extent of Confidentiality: There is no need for confidentiality required with this collection of information.

    Privacy Impact Assessment: No impact(s).

    Needs and Uses: Each licensee/permittee of a digital television (DTV) station must file on an annual basis FCC Form 317. Specifically, required filers include the following (but we generally refer to all such entities herein as a “DTV licensee/permittee”): A licensee of a digital commercial or noncommercial educational (NCE) full power television (TV) station, low power television (LPTV) station, TV translator or Class A TV station.

    A permittee operating pursuant to digital special temporary authority (STA) of a commercial or NCE full power TV station, LPTV station, TV translator or Class A TV station.

    Each DTV licensee/permittee must report whether they provided ancillary or supplementary services at any time during the reporting cycle. Each DTV licensee/permittee is required to retain the records supporting the calculation of the fees due for three years from the date of remittance of fees. Each NCE licensee/permittee must also retain for eight years documentation sufficient to show that its entire bitstream was used “primarily” for NCE broadcast services on a weekly basis.

    OMB Control Number: 30600-xxxx.

    Title: FCC Form 2100, Application for Media Bureau Video Service Authorization, Schedule 387 (Transition Progress Report).

    Form Number: FCC Form 2100, Schedule 387 (Transition Progress Report Form).

    Type of Review: New collection.

    Respondents: Business or other for-profit entities; not-for-profit institutions.

    Number of Respondents and Responses: 1,000 respondents; 3,333 responses.

    Estimated Time per Response: 2 hours (1 hour to complete the form, 1 hour to respond to technical questions).

    Frequency of Response: On occasion reporting requirement.

    Total Annual Burden: 6,666 hours.

    Total Annual Costs: $260,241.

    Obligation To Respond: Required to obtain or retain benefits. The statutory authority for this collection is contained in Public Law 112-96, 6402 (codified at 47 U.S.C. 309(j)(8)(G)), 6403 (codified at 47 U.S.C. 1452), 126 Stat. 156 (2012) (Spectrum Act).

    Nature and Extent of Confidentiality: There is no need for confidentiality with this collection of information.

    Privacy Impact Assessment(s): No impact(s).

    Needs and Uses: By Public Notice released January 10, 2017, The Incentive Auction Task Force and Media Bureau Release Transition Progress Report Form and Filing Requirements for Stations Eligible for Reimbursement from the TV Broadcast Relocation Fund and Seek Comment on the Filing of the Report by Non-Reimbursable Stations, MB Docket No. 16-306, Public Notice, 32 FCC Rcd 256 (IATF/Med. Bur. 2017). The Incentive Auction Task Force and Media Bureau described the information that must be provided in the adopted FCC Form 2100, Schedule 387 (Transition Progress Report Form) to be filed by Reimbursable Stations and when and how the Transition Progress Reports must be filed. We also proposed to require broadcast television stations that are not eligible to receive reimbursement of associated expenses from the Reimbursement Fund (Non-Reimbursable Stations), but must transition to new channels as part of the Commission's channel reassignment plan, to file progress reports in the same manner and on the same schedule as Reimbursable Stations, and sought comment on that proposal. By Public Notice released May 18, 2017. The Incentive Auction Task Force and Media Bureau Adopt Filing Requirements for the Transition Progress Report Form by Stations That Are Not Eligible for Reimbursement from the TV Broadcast Relocation Fund, MB Docket No. 16-306, Public Notice, DA 17-484 (rel. May 18, 2017) (referred to collectively with Public Notice cited above as Transition Progress Report Public Notices). We concluded that Non-Reimbursable Stations will be required to file Transition Progress Reports following the filing procedures adopted for Reimbursable Stations.

    The Commission is seeking from the Office of Management and Budget (OMB) approval for FCC Form 2100, Schedule 387 (Transition Progress Report).

    Federal Communications Commission. Katura Jackson, Federal Register Liaison Officer, Office of the Secretary.
    [FR Doc. 2017-16562 Filed 8-4-17; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL COMMUNICATIONS COMMISSION [OMB 3060-0761] Information Collection Being Reviewed by the Federal Communications Commission AGENCY:

    Federal Communications Commission.

    ACTION:

    Notice and request for comments.

    SUMMARY:

    As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.

    DATES:

    Written comments should be submitted on or before October 6, 2017. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contacts below as soon as possible.

    ADDRESSES:

    Direct all PRA comments to Cathy Williams, FCC, via email [email protected] and to [email protected]

    FOR FURTHER INFORMATION CONTACT:

    For additional information about the information collection, contact Cathy Williams at (202) 418-2918.

    SUPPLEMENTARY INFORMATION:

    As part of its continuing effort to reduce paperwork burdens, and as required by the PRA of 1995 (44 U.S.C. 3501-3520), the FCC invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.

    OMB Control Number: 3060-0761.

    Title: Section 79.1, Closed Captioning of Video Programming, CG Docket No. 05-231.

    Form No.: N/A.

    Type of Review: Revision of a currently approved collection.

    Respondents: Business or other for-profit entities; Individuals or households; and Not-for-profit entities.

    Number of Respondents and Responses: 59,995 respondents; 512,831 responses.

    Estimated Time per Response: 0.25 (15 minutes) to 60 hours.

    Frequency of Response: Annual reporting requirements; Third party disclosure requirement; Recordkeeping requirement.

    Obligation To Respond: Required to obtain or retain benefits. The statutory authority for this obligation is found at section 713 of the Communications Act of 1934, as amended, 47 U.S.C. 613, and implemented at 47 CFR 79.1.

    Total Annual Burden: 702,562 hours.

    Annual Cost Burden: $35,638,596.

    Nature and Extent of Confidentiality: Confidentiality is an issue to the extent that individuals and households provide personally identifiable information, which is covered under the FCC's system of records notice (SORN), FCC/CGB-1, “Informal Complaints, Inquiries, and Requests for Dispute Assistance.” As required by the Privacy Act, 5 U.S.C. 552a, the Commission also published a SORN, FCC/CGB-1 “Informal Complaints, Inquiries, and Requests for Dispute Assistance” in the Federal Register on August 15, 2014, published at 79 FR 48152, which became effective on September 24, 2014.

    Privacy Act Impact Assessment: Yes.

    Needs and Uses: The Commission seeks to extend existing information collection requirements in its closed captioning rules (47 CFR 79.1), which require that, with some exceptions, all new video programming, and 75 percent of ”pre-rule” programming, be closed captioned. The existing collections include petitions by video programming providers, producers, and owners for exemptions from the closed captioning rules, responses by commenters, and replies; complaints by viewers alleging violations of the closed captioning rules, responses by video programming distributors (VPDs) and video programmers, recordkeeping in support of complaint responses, and compliance ladder obligations in the event of a pattern or trend of violations; records of monitoring and maintenance activities; caption quality best practices procedures; making video programming distributor contact information available to viewers in phone directories, on the Commission's Web site and the Web sites of video programming distributors (if they have them), and in billing statements (to the extent video programming distributors issue them); and video programmers filing contact information and compliance certifications with the Commission.

    On February 19, 2016, the Commission adopted the Closed Captioning Quality Second Report and Order, published at 81 FR 57473, August 23, 2016, amending its rules to allocate the responsibilities of VPDs and video programmers with respect to the provision and quality of closed captioning. The Commission took the following actions, among others:

    (a) Required video programmers to file certifications with the Commission that (1) the video programmer (i) is in compliance with the rules requiring the inclusion of closed captions, and (ii) either is in compliance with the captioning quality standards or has adopted and is following related Best Practices; or (2) is exempt from the captioning obligation and specifies the exemption claimed.

    (b) Revised the procedures for receiving, serving, and addressing television closed captioning complaints in accordance with a burden-shifting compliance model.

    (c) Established a compliance ladder for the Commission's television closed captioning quality requirements.

    (d) Required VPDs to use the Commission's web form when providing contact information to the VPD registry.

    (e) Required video programmers to register their contact information with the Commission for the receipt and handling of written closed captioning complaints.

    Federal Communications Commission. Katura Jackson, Federal Register Liaison Officer, Office of the Secretary.
    [FR Doc. 2017-16563 Filed 8-4-17; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL MARITIME COMMISSION Agency Information Collection Activities: 60-Day Public Comment Request AGENCY:

    Federal Maritime Commission.

    ACTION:

    Notice and request for comments.

    SUMMARY:

    As part of our continuing effort to reduce paperwork and respondent burden, and as required by the Paperwork Reduction Act of 1995, the Federal Maritime Commission (Commission) invites comments on the continuing information collection (extension with no changes) listed below in this notice.

    DATES:

    Written comments must be submitted on or before October 6, 2017.

    ADDRESSES:

    Address all comments to: Karen V. Gregory, Managing Director, Office of the Managing Director, Federal Maritime Commission, 800 North Capitol Street NW., Washington, DC 20573, Phone: (202) 523-5800, Email: [email protected]

    FOR FURTHER INFORMATION CONTACT:

    Copies of the information collections and instructions, or copies of any comments received, may be obtained by contacting Donna Lee by phone at (202) 523-5800 or email at [email protected]

    SUPPLEMENTARY INFORMATION:

    Request for Comments

    The Commission, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to comment on the continuing information collection listed in this notice, as required by the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

    Comments submitted in response to this notice will be included or summarized in our request for Office of Management and Budget (OMB) approval of the relevant information collection. All comments are part of the public record and subject to disclosure. Please do not include any confidential or inappropriate material in your comments. We invite comments on: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

    Information Collection Open for Comment

    Title: 46 CFR part 565—Controlled Carriers.

    OMB Approval Number: 3072-0060 (Expires December 31, 2017).

    Abstract: Section 9 of the Shipping Act of 1984, 46 U.S.C. 40701-40706, requires that the Commission monitor the practices of controlled carriers to ensure that they do not maintain rates or charges in their tariffs and service contracts that are below a level that is just and reasonable; nor establish, maintain or enforce unjust or unreasonable classifications, rules or regulations in those tariffs or service contracts which result or are likely to result in the carriage or handling of cargo at rates or charges that are below a just and reasonable level. 46 CFR part 565 establishes the method by which the Commission determines whether a particular ocean common carrier is a controlled carrier subject to section 9 of the Shipping Act of 1984. When a government acquires a controlling interest in an ocean common carrier, or when a controlled carrier newly enters a United States trade, the Commission's rules require that such a carrier notify the Commission of these events.

    Current Actions: There are no changes to this information collection, and it is being submitted for extension purposes only.

    Type of Review: Extension.

    Needs and Uses: The Commission uses these notifications in order to effectively discharge its statutory duty to determine whether a particular ocean common carrier is a controlled carrier and therefore subject to the requirements of section 9 of the Shipping Act of 1984.

    Frequency: The submission of notifications from controlled carriers is not assigned to a specific time frame by the Commission; they are submitted as circumstances warrant. The Commission only requires notification when a majority portion of an ocean common carrier becomes owned or controlled by a government, or when a controlled carrier newly begins operation in any United States trade.

    Type of Respondents: Controlled carriers are ocean common carriers which are owned or controlled by a government.

    Number of Annual Respondents: The Commission cannot anticipate when a new controlled carrier may enter the United States trade or when ownership or control of a carrier will change so that notification is required. Over the past three years, the Commission has received, on average, one notification per year.

    Estimated Time per Response: The estimated time for each notification is 2 hours, and multiple responses may be filed each year.

    Total Annual Burden: For purposes of calculating total annual burden, the Commission assumes one response annually. The Commission thus estimates the total annual burden to be 2 hours (1 response × 2 hours per response).

    Rachel E. Dickon, Assistant Secretary.
    [FR Doc. 2017-16606 Filed 8-4-17; 8:45 am] BILLING CODE 6731-AA-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 August 22, 2017.

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

    1. GGC, LLP, an Iowa Limited Partnership, Council Bluffs, Iowa; Richard Gibson, Kim Gibson, and Tracy Connealy, all of Council Bluffs, Iowa; as a group acting in concert, to retain and acquire additional voting shares of TS Contrarian Bancshares, Inc., Treynor, Iowa and thereby indirectly acquire voting shares of The Bank of Tioga, Tioga, North Dakota and First National Bank & Trust Company, Clinton, Illinois.

    B. Federal Reserve Bank of St. Louis (David L. Hubbard, Senior Manager) P.O. Box 442, St. Louis, Missouri 63166-2034. Comments can also be sent electronically to [email protected]:

    1. Nancy Toler Grigsby, individually and as trustee of the Nancy Toler Grigsby Trust UTA 11/22/2010, the Cynthia Toler Hale Trust UTA 11/22/2010, and the John A. Grigsby Trust A, and as a family control group that also includes Cynthia Toler Hale; to retain voting shares of MNB Bancshares, Inc., and thereby retain shares of The Malvern National Bank, all of Malvern, Arkansas.

    Board of Governors of the Federal Reserve System, August 2, 2017. Yao-Chin Chao, Assistant Secretary of the Board.
    [FR Doc. 2017-16600 Filed 8-4-17; 8:45 am] BILLING CODE 6210-01-P
    FEDERAL RESERVE SYSTEM Formations of, Acquisitions by, and Mergers of Savings and Loan Holding Companies

    The companies listed in this notice have applied to the Board for approval, pursuant to the Home Owners' Loan Act (12 U.S.C. 1461 et seq.) (HOLA), Regulation LL (12 CFR part 238), and Regulation MM (12 CFR part 239), and all other applicable statutes and regulations to become a savings and loan holding company and/or to acquire the assets or the ownership of, control of, or the power to vote shares of a savings association and nonbanking companies owned by the savings and loan 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 application also will 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 HOLA (12 U.S.C. 1467a(e)). 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 10(c)(4)(B) of the HOLA (12 U.S.C. 1467a(c)(4)(B)). Unless otherwise noted, nonbanking activities will be conducted throughout the United States.

    Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than August 31, 2017.

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

    1. Pedcor Capital, LLC, Pedcor Bancorp, and American Capital Bancorp, of Carmel, Indiana; to become a savings and loan holding company upon the conversion of International City Bank, Long Beach, California, to a federal savings bank.

    Board of Governors of the Federal Reserve System, August 1, 2017. Yao-Chin Chao, Assistant Secretary of the Board.
    [FR Doc. 2017-16512 Filed 8-4-17; 8:45 am] BILLING CODE P
    FEDERAL RESERVE SYSTEM Formations of, Acquisitions by, and Mergers of Bank Holding Companies

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

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

    Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than September 1, 2017.

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

    1. Hometown Community Bancorp, Inc. and Hometown Community Bancorp, Inc. ESOP, both of Morton, Illinois; to acquire 100 percent of the voting shares of Arthur Bancshares Corp. and thereby indirectly acquire State Bank of Arthur, both of Arthur, Illinois.

    Board of Governors of the Federal Reserve System, August 2, 2017. Yao-Chin Chao, Assistant Secretary of the Board. [FR Doc. 2017-16601 Filed 8-4-17; 8:45 am] BILLING CODE 6210-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-1673-NC] RIN 0938-AS97 Medicare Program; FY 2018 Inpatient Psychiatric Facilities Prospective Payment System—Rate Update AGENCY:

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

    ACTION:

    Notice with comment period.

    SUMMARY:

    This notice with comment period updates the prospective payment rates for Medicare inpatient hospital services provided by inpatient psychiatric facilities (IPFs), which include freestanding IPFs and psychiatric units of an acute care hospital or critical access hospital. These changes are applicable to IPF discharges occurring during the fiscal year (FY) beginning October 1, 2017 through September 30, 2018 (FY 2018).

    DATES:

    The updated IPF prospective payment rates are effective for discharges occurring on or after October 1, 2017 through September 30, 2018.

    Comment Date: To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on October 6, 2017.

    ADDRESSES:

    In commenting, refer to file code CMS-1673-NC. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.

    You may submit comments in one of four ways (please choose only one of the ways listed):

    1. Electronically. You may submit electronic comments on this regulation to http://www.regulations.gov. Follow the “Submit a comment” instructions.

    2. By regular mail. You may mail written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-1673-NC, P.O. Box 8010, Baltimore, MD 21244-1850.

    Please allow sufficient time for mailed comments to be received before the close of the comment period.

    3. By express or overnight mail. You may send written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-1673-NC, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.

    4. By hand or courier. Alternatively, you may deliver (by hand or courier) your written comments ONLY to the following addresses:

    a. For delivery in Washington, DC—Centers for Medicare & Medicaid Services, Department of Health and Human Services, Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue SW., Washington, DC 20201.

    (Because access to the interior of the Hubert H. Humphrey Building is not readily available to persons without Federal government identification, commenters are encouraged to leave their comments in the CMS drop slots located in the main lobby of the building. A stamp-in clock is available for persons wishing to retain a proof of filing by stamping in and retaining an extra copy of the comments being filed.)

    b. For delivery in Baltimore, MD—Centers for Medicare & Medicaid Services, Department of Health and Human Services, 7500 Security Boulevard, Baltimore, MD 21244-1850.

    If you intend to deliver your comments to the Baltimore address, call telephone number (410) 786-9994 in advance to schedule your arrival with one of our staff members.

    Comments erroneously mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period. For information on viewing public comments, see the beginning of the SUPPLEMENTARY INFORMATION section.

    FOR FURTHER INFORMATION CONTACT:

    The IPF Payment Policy mailbox at [email protected] for general information. Theresa Bean (410) 786-2287 or James Hardesty (410) 786-2629 for information regarding the regulatory impact analysis.

    SUPPLEMENTARY INFORMATION:

    Inspection of Public Comments: All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following Web site as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that Web site to view public comments.

    Comments received timely will also be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, phone 1-800-743-3951.

    Availability of Certain Tables Exclusively Through the Internet on the CMS Web site

    Tables setting forth the fiscal year (FY) 2018 Wage Index for Urban Areas Based on Core-Based Statistical Area (CBSA) Labor Market Areas and the Wage Index Based on CBSA Labor Market Areas for Rural Areas are available exclusively through the Internet, on the CMS Web site at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/IPFPPS/WageIndex.html.

    In addition, tables showing the complete listing of ICD-10 Clinical Modification (CM) and Procedure Coding System (PCS) codes underlying the FY 2018 Inpatient Psychiatric Facilities (IPF) Prospective Payment System (PPS) for comorbidity adjustment, code first, and Electroconvulsive Therapy (ECT) are available online at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientPsychFacilPPS/tools.html. Addendum B to this notice with comment period only shows the table of changes to the ICD-10-CM/PCS codes which affect FY 2018 IPF PPS comorbidity categories.

    To assist readers in referencing sections contained in this document, we are providing the following table of contents.

    Table of Contents I. Executive Summary A. Purpose B. Summary of the Major Provisions C. Summary of Impacts II. Background A. Overview of the Legislative Requirements of the IPF PPS B. Overview of the IPF PPS C. Annual Requirements for Updating the IPF PPS III. Provisions of the FY 2018 IPF PPS Notice A. Updated FY 2018 Market Basket for the IPF PPS 1. Background 2. FY 2018 IPF Market Basket Update 3. IPF Labor-Related Share B. Updates to the IPF PPS Rates for FY Beginning October 1, 2017 1. Determining the Standardized Budget-Neutral Federal Per Diem Base Rate 2. Update of the Federal Per Diem Base Rate and Electroconvulsive Therapy Payment per Treatment C. Updates to the IPF PPS Patient-Level Adjustment Factors 1. Overview of the IPF PPS Adjustment Factors 2. IPF-PPS Patient-Level Adjustments a. MS-DRG Assignment • Code First b. Payment for Comorbid Conditions 3. Patient Age Adjustments 4. Variable Per Diem Adjustments D. Updates to the IPF PPS Facility-Level Adjustments 1. Wage Index Adjustment a. Background b. Updated Wage Index for FY 2018 c. OMB Bulletins d. Adjustment for Rural Location e. Budget Neutrality Adjustment 2. Teaching Adjustment 3. Cost of Living Adjustment for IPFs Located in Alaska and Hawaii 4. Adjustment for IPFs with a Qualifying Emergency Department (ED) E. Other Payment Adjustments and Policies 1. Outlier Payment Overview 2. Update to the Outlier Fixed Dollar Loss Threshold Amount 3. Update to IPF Cost-to-Charge Ratio Ceilings IV. Update on IPF PPS Refinements V. Waiver of Notice and Comment VI. Request for Information on CMS Flexibilities and Efficiencies VII. Collection of Information Requirements VIII. Response to Comments IX. Regulatory Impact Analysis A. Statement of Need B. Overall Impact C. Anticipated Effects 1. Budgetary Impact 2. Impact on Providers 3. Results 4. Effect on Beneficiaries 5. Regulatory Review Costs 6. Reducing Regulation and Controlling Regulatory Costs D. Alternatives Considered E. Accounting Statement Addendum A—IPF PPS FY 2018 Rates and Adjustment Factors Addendum B—Changes to the FY 2018 ICD-10-CM/PCS Code Sets Which Affect the FY 2018 IPF PPS Comorbidity Categories and the Code First List Acronyms

    Because of the many terms to which we refer by acronym in this notice with comment period, we are listing the acronyms used and their corresponding meanings in alphabetical order below:

     ADC Average Daily Census  BBRA Medicare, Medicaid and SCHIP [State Children's Health Insurance Program] Balanced Budget Refinement Act of 1999 (Pub. L. 106-113)  BLS Bureau of Labor Statistics  CAH Critical Access Hospital  CBSA Core-Based Statistical Area  CCR Cost-to-Charge Ratio  CPI Consumer Price Index  CPI-U Consumer Price Index for all Urban Consumers  CY Calendar Year  DRGs Diagnosis-Related Groups  ECT Electroconvulsive Therapy  ESRD End State Renal Disease  FR Federal Register  FTE Full-time equivalent  FY Federal Fiscal Year (October 1 through September 30)  GDP Gross Domestic Product  GME Graduate Medical Education  HCRIS Healthcare Cost Report Information System  ICD-9-CM International Classification of Diseases, 9th Revision, Clinical Modification  ICD-10-CM International Classification of Diseases, 10th Revision, Clinical Modification  ICD-10-PCS International Classification of Diseases, 10th Revision, Procedure Coding System  IGI IHS Global, Inc.  IPF Inpatient Psychiatric Facility  IPFQR Inpatient Psychiatric Facilities Quality Reporting  IPPS Inpatient Prospective Payment System  IRFs Inpatient Rehabilitation Facilities  LOS Length of Stay  LRS Labor-related Share  LTCHs Long-Term Care Hospitals  MAC Medicare Administrative Contractor  MedPAR Medicare Provider Analysis and Review File  MFP Multifactor Productivity  MMA Medicare Prescription Drug, Improvement, and Modernization Act of 2003  MSA Metropolitan Statistical Area  MS-DRG Medicare Severity-Diagnosis Related Group  NDAA National Defense Authorization Act  NQF National Quality Forum  OMB Office of Management and Budget  OPPS Outpatient Prospective Payment System  POS Provider of Services  PPS Prospective Payment System  RFA Regulatory Flexibility Act  RFI Request for Information  RPL Rehabilitation, Psychiatric, and Long-Term Care  RY Rate Year  SBA Small Business Administration  SCHIP State Children's Health Insurance Program  SNF Skilled Nursing Facility  TEFRA Tax Equity and Fiscal Responsibility Act of 1982 (Pub. L. 97-248) I. Executive Summary A. Purpose

    This notice with comment period updates the prospective payment rates, the outlier threshold, and the wage index for Medicare inpatient hospital services provided by IPFs for discharges occurring during the FY beginning October 1, 2017 through September 30, 2018.

    B. Summary of the Major Provisions

    In this notice with comment period, we are updating the IPF Prospective Payment System (PPS), as specified in 42 CFR 412.428. The updates include the following:

    • For FY 2018, we adjusted the 2012-based IPF market basket update (2.6 percent) by a reduction for economy-wide productivity (0.6 percentage point) as required by section 1886(s)(2)(A)(i) of the Social Security Act (the Act). We further reduced the 2012-based IPF market basket update by 0.75 percentage point as required by section 1886(s)(2)(A)(ii) of the Act, resulting in an estimated IPF payment rate update of 1.25 percent for FY 2018.

    • The 2012-based IPF market basket resulted in a labor-related share of 75.0 percent for FY 2018.

    • We updated the IPF PPS per diem rate from $761.37 to $771.35. Providers that failed to report quality data for FY 2018 payment will receive a FY 2018 per diem rate of $756.11.

    • We updated the ECT payment per treatment from $327.78 to $332.08. Providers that failed to report quality data for FY 2018 payment will receive a FY 2018 ECT payment per treatment of $325.52.

    • We used the updated labor-related share of 75.0 percent (based on the 2012-based IPF market basket) and CBSA rural and urban wage indices for FY 2018, and established a wage index budget-neutrality adjustment of 1.0006. The FY 2018 IPF wage index includes minor updates to a few CBSA delineations based upon a July 15, 2015 OMB Bulletin.

    • We updated the fixed dollar loss threshold amount from $10,120 to $11,425 in order to maintain estimated outlier payments at 2 percent of total estimated aggregate IPF PPS payments.

    C. Summary of Impacts Provision description Total transfers FY 2018 IPF PPS payment update The overall economic impact of this notice with comment period is an estimated $45 million in increased payments to IPFs during FY 2018. II. Background A. Overview of the Legislative Requirements for the IPF PPS

    Section 124 of the Medicare, Medicaid, and SCHIP (State Children's Health Insurance Program) Balanced Budget Refinement Act of 1999 (BBRA) (Pub. L. 106-113) required the establishment and implementation of an IPF PPS. Specifically, section 124 of the BBRA mandated that the Secretary of the Department of Health and Human Services (the Secretary) develop a per diem PPS for inpatient hospital services furnished in psychiatric hospitals and certified psychiatric units including an adequate patient classification system that reflects the differences in patient resource use and costs among psychiatric hospitals and psychiatric units.

    Section 405(g)(2) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173) extended the IPF PPS to distinct part psychiatric units of critical access hospitals (CAHs).

    Sections 3401(f) and 10322 of the Patient Protection and Affordable Care Act (Pub. L. 111-148) as amended by section 10319(e) of that Act and by section 1105(d) of the Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152) (hereafter referred to jointly as “the Affordable Care Act”) added subsection (s) to section 1886 of the Act.

    Section 1886(s)(1) of the Act titled “Reference to Establishment and Implementation of System,” refers to section 124 of the BBRA, which relates to the establishment of the IPF PPS.

    Section 1886(s)(2)(A)(i) of the Act requires the application of the productivity adjustment described in section 1886(b)(3)(B)(xi)(II) of the Act to the IPF PPS for the Rate Year (RY) beginning in 2012 (that is, a RY that coincides with a FY) and each subsequent RY. As noted in our previous IPF PPS notice (the FY 2017 IPF PPS notice), for the RY beginning in 2016 (that is, FY 2017), the productivity adjustment currently in place is equal to 0.3 percent.

    Section 1886(s)(2)(A)(ii) of the Act requires the application of an “other adjustment” that reduces any update to an IPF PPS base rate by percentages specified in section 1886(s)(3) of the Act for the RY beginning in 2010 through the RY beginning in 2019. As noted in our previous (FY 2017) IPF PPS notice, for the RY beginning in 2016 (that is, FY 2017), section 1886(s)(3)(D) of the Act requires that the reduction currently in place be equal to 0.2 percentage point.

    Sections 1886(s)(4)(A) and 1886(s)(4)(B) of the Act require that for RY 2014 and each subsequent rate year, IPFs that fail to report required quality data with respect to such a rate year shall have their annual update to a standard federal rate for discharges reduced by 2.0 percentage points. This may result in an annual update being less than 0.0 for a rate year, and may result in payment rates for the upcoming rate year being less than such payment rates for the preceding rate year. Any reduction for failure to report required quality data shall apply only to the rate year involved, and the Secretary shall not take into account such reduction in computing the payment amount for a subsequent rate year. More information about the IPF Quality Reporting Program is available in the August 22, 2016 FY 2017 Hospital IPPS for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System final rule (81 FR 57236 through 57249) and the FY 2018 Hospital IPPS for Acute Care Hospitals and the Long-Term Care Hospital PPS proposed rule (82 FR 20120 through 20130).

    To implement and periodically update these provisions, we have published various proposed and final rules and notices in the Federal Register. For more information regarding these documents, see the CMS Web site at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientPsychFacilPPS/index.html?redirect=/InpatientPsychFacilPPS/.

    B. Overview of the IPF PPS

    The November 2004 IPF PPS final rule (69 FR 66922) established the IPF PPS, as required by section 124 of the BBRA and codified at subpart N of part 412 of the Medicare regulations. The November 2004 IPF PPS final rule set forth the per diem federal rates for the implementation year (the 18-month period from January 1, 2005 through June 30, 2006), and provided payment for the inpatient operating and capital costs to IPFs for covered psychiatric services they furnish (that is, routine, ancillary, and capital costs, but not costs of approved educational activities, bad debts, and other services or items that are outside the scope of the IPF PPS). Covered psychiatric services include services for which benefits are provided under the fee-for-service Part A (Hospital Insurance Program) of the Medicare program.

    The IPF PPS established the federal per diem base rate for each patient day in an IPF derived from the national average daily routine operating, ancillary, and capital costs in IPFs in FY 2002. The average per diem cost was updated to the midpoint of the first year under the IPF PPS, standardized to account for the overall positive effects of the IPF PPS payment adjustments, and adjusted for budget-neutrality.

    The federal per diem payment under the IPF PPS is comprised of the federal per diem base rate described previously and certain patient- and facility-level payment adjustments that were found in the regression analysis to be associated with statistically significant per diem cost differences.

    The patient-level adjustments include age, Diagnosis-Related Group (DRG) assignment, comorbidities; additionally, there are variable per diem adjustments to reflect higher per diem costs at the beginning of a patient's IPF stay. Facility-level adjustments include adjustments for the IPF's wage index, rural location, teaching status, a cost-of-living adjustment for IPFs located in Alaska and Hawaii, and an adjustment for the presence of a qualifying Emergency Department (ED).

    The IPF PPS provides additional payment policies for: Outlier cases; interrupted stays; and a per treatment payment for patients who undergo ECT. During the IPF PPS mandatory 3-year transition period, stop-loss payments were also provided; however, since the transition ended in 2008, these payments are no longer available.

    A complete discussion of the regression analysis that established the IPF PPS adjustment factors appears in the November 2004 IPF PPS final rule (69 FR 66933 through 66936).

    Section 124 of the BBRA did not specify an annual rate update strategy for the IPF PPS and was broadly written to give the Secretary discretion in establishing an update methodology. Therefore, in the November 2004 IPF PPS final rule, we implemented the IPF PPS using the following update strategy:

    • Calculate the final federal per diem base rate to be budget-neutral for the 18-month period of January 1, 2005 through June 30, 2006.

    • Use a July 1 through June 30 annual update cycle.

    • Allow the IPF PPS first update to be effective for discharges on or after July 1, 2006 through June 30, 2007.

    In RY 2012, we proposed and finalized switching the IPF PPS payment rate update from a rate year that begins on July 1 and ends on June 30 to one that coincides with the federal FY that begins October 1 and ends on September 30. In order to transition from one timeframe to another, the RY 2012 IPF PPS covered a 15-month period from July 1, 2011 through September 30, 2012. For further discussion of the 15-month market basket update for RY 2012 and changing the payment rate update period to coincide with a FY period, we refer readers to the RY 2012 IPF PPS proposed rule (76 FR 4998) and the RY 2012 IPF PPS final rule (76 FR 26432).

    C. Annual Requirements for Updating the IPF PPS

    In November 2004, we implemented the IPF PPS in a final rule that appeared in the November 15, 2004 Federal Register (69 FR 66922). In developing the IPF PPS, to ensure that the IPF PPS is able to account adequately for each IPF's case-mix, we performed an extensive regression analysis of the relationship between the per diem costs and certain patient and facility characteristics to determine those characteristics associated with statistically significant cost differences on a per diem basis. For characteristics with statistically significant cost differences, we used the regression coefficients of those variables to determine the size of the corresponding payment adjustments.

    In that final rule, we explained the reasons for delaying an update to the adjustment factors, derived from the regression analysis, until we have IPF PPS data that include as much information as possible regarding the patient-level characteristics of the population that each IPF serves. We indicated that we did not intend to update the regression analysis and the patient-level and facility-level adjustments until we complete that analysis. Until that analysis is complete, we stated our intention to publish a notice in the Federal Register each spring to update the IPF PPS (71 FR 27041).

    In the May 6, 2011 IPF PPS final rule (76 FR 26432), we changed the payment rate update period to a RY that coincides with a FY update. Therefore, update notices are now published in the Federal Register in the summer to be effective on October 1. When proposing changes in IPF payment policy, a proposed rule would be issued in the spring and the final rule in the summer in order to be effective on October 1. For further discussion on changing the IPF PPS payment rate update period to a RY that coincides with a FY, see the IPF PPS final rule published in the Federal Register on May 6, 2011 (76 FR 26434 through 26435). For a detailed list of updates to the IPF PPS, see 42 CFR 412.428.

    Our most recent IPF PPS annual update occurred in an August 1, 2016, Federal Register notice (81 FR 50502) (hereinafter referred to as the August 2016 IPF PPS notice), which updated the IPF PPS payment rates for FY 2017. That notice updated the IPF PPS per diem payment rates that were published in the August 2015 IPF PPS final rule (80 FR 46652) in accordance with our established policies.

    III. Provisions of the FY 2018 IPF PPS Notice A. Updated FY 2018 Market Basket for the IPF PPS 1. Background

    The input price index that was used to develop the IPF PPS was the “Excluded Hospital with Capital” market basket. This market basket was based on 1997 Medicare cost reports for Medicare participating inpatient rehabilitation facilities (IRFs), IPFs, long-term care hospitals (LTCHs), cancer hospitals, and children's hospitals. Although “market basket” technically describes the mix of goods and services used in providing health care at a given point in time, this term is also commonly used to denote the input price index (that is, cost category weights and price proxies) derived from that market basket. Accordingly, the term “market basket,” as used in this document, refers to an input price index.

    Beginning with the May 2006 IPF PPS final rule (71 FR 27046 through 27054), IPF PPS payments were updated using a 2002-based rehabilitation, psychiatric, and long-term care (RPL) market basket reflecting the operating and capital cost structures for freestanding IRFs, freestanding IPFs, and LTCHs. Cancer and children's hospitals were excluded from the RPL market basket because their payments are based entirely on reasonable costs subject to rate-of-increase limits established under the authority of section 1886(b) of the Act and not through a PPS. Also, the 2002 cost structures for cancer and children's hospitals are noticeably different than the cost structures of freestanding IRFs, freestanding IPFs, and LTCHs. See the May 2006 IPF PPS final rule (71 FR 27046 through 27054) for a complete discussion of the 2002-based RPL market basket.

    Beginning with the RY 2012 IPF PPS final rule (76 FR 26432), IPF PPS payments were updated using a 2008-based RPL market basket reflecting the operating and capital cost structures for freestanding IRFs, freestanding IPFs, and LTCHs. The major changes for RY 2012 included: Updating the base year from FY 2002 to FY 2008; using a more specific composite chemical price proxy; breaking the professional fees cost category into two separate categories (Labor-related and Non-labor-related); and adding two additional cost categories (Administrative and Facilities Support Services, and Financial Services), which were previously included in the residual All Other Services cost categories. The RY 2012 IPF PPS proposed rule (76 FR 4998) and RY 2012 final rule (76 FR 26432) contain a complete discussion of the development of the 2008-based RPL market basket.

    In the FY 2016 IPF PPS proposed rule, we proposed to create a 2012-based IPF market basket, using Medicare cost report data for both freestanding and hospital-based IPFs. We first expressed our interest in exploring the possibility of creating a stand-alone IPF market basket in the May 1, 2009 IPF PPS notice (74 FR 20376). In the FY 2016 PPS proposed rule, we solicited comments on the 2012-based IPF market basket. After consideration of these public comments, we finalized the creation and adoption of a 2012-based IPF market basket with a modification to the Wages and Salaries and Employee Benefits cost methodologies based on public comments. We believe that the use of the 2012-based IPF market basket to update IPF PPS payments is a technical improvement as it is based on Medicare Cost Report data from both freestanding and hospital-based IPFs. Furthermore, the 2012-based IPF market basket does not include costs from either IRF or LTCH providers, which were included in the 2008-based RPL market basket. We refer readers to the FY 2016 IPF PPS final rule for a detailed discussion of the 2012-based IPF PPS Market Basket and its development (80 FR46656 through 46679).

    2. FY 2018 IPF Market Basket Update

    For FY 2018 (beginning October 1, 2017 and ending September 30, 2018), we use an estimate of the 2012-based IPF market basket increase factor to update the IPF PPS base payment rate. Consistent with historical practice, we estimate the market basket update for the IPF PPS based on IHS Global, Inc.'s (IGI) forecast. IGI is a nationally recognized economic and financial forecasting firm that contracts with the CMS to forecast the components of the market baskets and multifactor productivity (MFP). Based on IGI's second quarter 2017 forecast with historical data through the first quarter of 2017, the 2012-based IPF market basket increase factor for FY 2018 is 2.6 percent.

    Section 1886(s)(2)(A)(i) of the Act requires the application of the productivity adjustment described in section 1886(b)(3)(B)(xi)(II) of the Act to the IPF PPS for the RY beginning in 2012 (a RY that coincides with a FY) and each subsequent RY. For this FY 2018 IPF PPS Notice, based on IGI's second quarter 2017 forecast, the MFP adjustment for FY 2018 (the 10-year moving average of MFP for the period ending FY 2018) is projected to be 0.6 percent. We reduced the 2.6 percent IPF market basket update by this 0.6 percentage point productivity adjustment, as mandated by the Act. For more information on the productivity adjustment, please see the discussion in the FY 2016 IPF PPS final rule (80 FR 46675).

    In addition, for FY 2018 the 2012-based IPF PPS market basket update is further reduced by 0.75 percentage point as required by sections 1886(s)(2)(A)(ii) and 1886(s)(3)(E) of the Act. This results in an estimated FY 2018 IPF PPS payment rate update of 1.25 percent (2.6−0.6−0.75 = 1.25).

    3. IPF Labor-Related Share

    Due to variations in geographic wage levels and other labor-related costs, we believe that payment rates under the IPF PPS should continue to be adjusted by a geographic wage index, which would apply to the labor-related portion of the federal per diem base rate (hereafter referred to as the labor-related share).

    The labor-related share is determined by identifying the national average proportion of total costs that are related to, influenced by, or vary with the local labor market. We continue to classify a cost category as labor-related if the costs are labor-intensive and vary with the local labor market.

    Based on our definition of the labor-related share and the cost categories in the 2012-based IPF market basket, we are continuing to include in the labor-related share the sum of the relative importance of Wages and Salaries; Employee Benefits; Professional Fees: Labor-Related; Administrative and Facilities Support Services; Installation, Maintenance, and Repair; All Other: Labor-related Services; and a portion (46 percent) of the Capital-Related cost weight from the 2012-based IPF market basket. The relative importance reflects the different rates of price change for these cost categories between the base year (FY 2012) and FY 2018. Using IGI's second quarter 2017 forecast for the 2012-based IPF market basket, the IPF labor-related share for FY 2018 is the sum of the FY 2018 relative importance of each labor-related cost category. Please see the FY 2016 IPF PPS final rule for more information on the labor-related share and its calculation (80 FR 46676 through 46679). For FY 2018, the updated labor-related share based on IGI's second quarter 2017 forecast of the 2012-based IPF PPS market basket is 75.0 percent.

    B. Updates to the IPF PPS Rates for FY Beginning October 1, 2017

    The IPF PPS is based on a standardized federal per diem base rate calculated from the IPF average per diem costs and adjusted for budget-neutrality in the implementation year. The federal per diem base rate is used as the standard payment per day under the IPF PPS and is adjusted by the patient-level and facility-level adjustments that are applicable to the IPF stay. A detailed explanation of how we calculated the average per diem cost appears in the November 2004 IPF PPS final rule (69 FR 66926).

    1. Determining the Standardized Budget-Neutral Federal Per Diem Base Rate

    Section 124(a)(1) of the BBRA required that we implement the IPF PPS in a budget-neutral manner. In other words, the amount of total payments under the IPF PPS, including any payment adjustments, must be projected to be equal to the amount of total payments that would have been made if the IPF PPS were not implemented. Therefore, we calculated the budget-neutrality factor by setting the total estimated IPF PPS payments to be equal to the total estimated payments that would have been made under the Tax Equity and Fiscal Responsibility Act of 1982 (TEFRA) (Pub. L. 97-248) methodology had the IPF PPS not been implemented. A step-by-step description of the methodology used to estimate payments under the TEFRA payment system appears in the November 2004 IPF PPS final rule (69 FR 66926).

    Under the IPF PPS methodology, we calculated the final federal per diem base rate to be budget-neutral during the IPF PPS implementation period (that is, the 18-month period from January 1, 2005 through June 30, 2006) using a July 1 update cycle. We updated the average cost per day to the midpoint of the IPF PPS implementation period (October 1, 2005), and this amount was used in the payment model to establish the budget-neutrality adjustment.

    Next, we standardized the IPF PPS federal per diem base rate to account for the overall positive effects of the IPF PPS payment adjustment factors by dividing total estimated payments under the TEFRA payment system by estimated payments under the IPF PPS. Additional information concerning this standardization can be found in the November 2004 IPF PPS final rule (69 FR 66932) and the RY 2006 IPF PPS final rule (71 FR 27045). We then reduced the standardized federal per diem base rate to account for the outlier policy, the stop loss provision, and anticipated behavioral changes. A complete discussion of how we calculated each component of the budget-neutrality adjustment appears in the November 2004 IPF PPS final rule (69 FR 66932 through 66933) and in the May 2006 IPF PPS final rule (71 FR 27044 through 27046). The final standardized budget-neutral federal per diem base rate established for cost reporting periods beginning on or after January 1, 2005 was calculated to be $575.95.

    The federal per diem base rate has been updated in accordance with applicable statutory requirements and § 412.428 through publication of annual notices or proposed and final rules. A detailed discussion on the standardized budget-neutral federal per diem base rate and the electroconvulsive therapy (ECT) payment per treatment appears in the August 2013 IPF PPS update notice (78 FR 46738 through 46739). These documents are available on the CMS Web site at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientPsychFacilPPS/index.html.

    IPFs must include a valid procedure code for ECT services provided to IPF beneficiaries in order to bill for ECT services, as described in our Medicare Claims Processing Manual, Chapter 3, Section 190.7.3 (available at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c03.pdf.) There were no changes to the ECT procedure codes used on IPF claims as a result of the update to the ICD-10-PCS code set for FY 2018.

    2. Update of the Federal per Diem Base Rate and Electroconvulsive Therapy Payment per Treatment

    The current (FY 2017) federal per diem base rate is $761.37 and the ECT payment per treatment is $327.78. For FY 2018, we applied a payment rate update of 1.25 percent (that is, the 2012-based IPF market basket increase for FY 2018 of 2.6 percent less the productivity adjustment of 0.6 percentage point, and further reduced by the 0.75 percentage point required under section 1886(s)(3)(E) of the Act), and the wage index budget-neutrality factor of 1.0006 (as discussed in section III.D.1.e of this notice with comment period) to the FY 2017 federal per diem base rate of $761.37, yielding a federal per diem base rate of $771.35 for FY 2018. Similarly, we applied the 1.25 percent payment rate update and the 1.0006 wage index budget-neutrality factor to the FY 2017 ECT payment per treatment, yielding an ECT payment per treatment of $332.08 for FY 2018.

    Section 1886(s)(4)(A)(i) of the Act requires that, for RY 2014 and each subsequent RY, in the case of an IPF that fails to report required quality data with respect to such rate year, the Secretary shall reduce any annual update to a standard federal rate for discharges during the RY by 2.0 percentage points. Therefore, we are applying a 2.0 percentage point reduction to the federal per diem base rate and the ECT payment per treatment as follows: For IPFs that failed to submit quality reporting data under the Inpatient Psychiatric Facilities Quality Reporting (IPFQR) Program, we are applying a −0.75 percent payment rate update (that is, 1.25 percent reduced by 2 percentage points in accordance with section 1886(s)(4)(A)(ii) of the Act, which results in a negative update percentage) and the wage index budget-neutrality factor of 1.0006 to the FY 2017 federal per diem base rate of $761.37, yielding a federal per diem base rate of $756.11 for FY 2018. Similarly, for IPFs that failed to submit quality reporting data under the IPFQR Program, we are applying the −0.75 percent annual payment rate update and the 1.0006 wage index budget-neutrality factor to the FY 2017 ECT payment per treatment of $327.78, yielding an ECT payment per treatment of $325.52 for FY 2018.

    C. Updates to the IPF PPS Patient-Level Adjustment Factors 1. Overview of the IPF PPS Adjustment Factors

    The IPF PPS payment adjustments were derived from a regression analysis of 100 percent of the FY 2002 MedPAR data file, which contained 483,038 cases. For a more detailed description of the data file used for the regression analysis, see the November 2004 IPF PPS final rule (69 FR 66935 through 66936). We continue to use the existing regression-derived adjustment factors established in 2005 for FY 2018. However, we have used more recent claims data to simulate payments to set the outlier fixed dollar loss threshold amount and to assess the impact of the IPF PPS updates.

    2. IPF-PPS Patient-Level Adjustments

    The IPF PPS includes payment adjustments for the following patient-level characteristics: Medicare Severity Diagnosis Related Groups (MS-DRGs) assignment of the patient's principal diagnosis, selected comorbidities, patient age, and the variable per diem adjustments.

    a. MS-DRG Assignment

    We believe it is important to maintain the same diagnostic coding and DRG classification for IPFs that are used under the Inpatient Prospective Payment System (IPPS) for providing psychiatric care. For this reason, when the IPF PPS was implemented for cost reporting periods beginning on or after January 1, 2005, we adopted the same diagnostic code set (ICD-9-CM) and DRG patient classification system (CMS DRGs) that were utilized at the time under the IPPS. In the May 2008 IPF PPS notice (73 FR 25709), we discussed CMS' effort to better recognize resource use and the severity of illness among patients. CMS adopted the new MS-DRGs for the IPPS in the FY 2008 IPPS final rule with comment period (72 FR 47130). In the 2008 IPF PPS notice (73 FR 25716), we provided a crosswalk to reflect changes that were made under the IPF PPS to adopt the new MS-DRGs. For a detailed description of the mapping changes from the original DRG adjustment categories to the current MS-DRG adjustment categories, we refer readers to the May 2008 IPF PPS notice (73 FR 25714).

    The IPF PPS includes payment adjustments for designated psychiatric DRGs assigned to the claim based on the patient's principal diagnosis. The DRG adjustment factors were expressed relative to the most frequently reported psychiatric DRG in FY 2002, that is, DRG 430 (psychoses). The coefficient values and adjustment factors were derived from the regression analysis. Mapping the DRGs to the MS-DRGs resulted in the current 17 IPF MS-DRGs, instead of the original 15 DRGs, for which the IPF PPS provides an adjustment. For the FY 2018 update, we are not making any changes to the IPF MS-DRG adjustment factors.

    In FY 2015 rulemaking (79 FR 45945 through 45947), we proposed and finalized conversions of the ICD-9-CM-based MS-DRGs to ICD-10-CM/PCS-based MS-DRGs, which were implemented on October 1, 2015. Further information on the ICD-10-CM/PCS MS-DRG conversion project can be found on the CMS ICD-10-CM Web site at https://www.cms.gov/Medicare/Coding/ICD10/ICD-10-MS-DRG-Conversion-Project.html.

    For FY 2018, we will continue to make a payment adjustment for psychiatric diagnoses that group to one of the existing 17 IPF MS-DRGs listed in Addendum A of this notice with comment period. Psychiatric principal diagnoses that do not group to one of the 17 designated DRGs will still receive the federal per diem base rate and all other applicable adjustments, but the payment would not include a DRG adjustment.

    The diagnoses for each IPF MS-DRG will be updated as of October 1, 2017, using the final FY 2018 ICD-10-CM/PCS code sets. The FY 2018 IPPS Final Rule with comment period includes tables of the changes to the ICD-10-CM/PCS code sets which underlie the FY 2018 IPF MS-DRGs. Both the FY 2018 IPPS final rule and the tables of changes to the ICD-10-CM/PCS code sets which underlie the FY 2018 MS-DRGs are available on the IPPS Web site at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html.

    Code First

    As discussed in the ICD-10-CM Official Guidelines for Coding and Reporting, certain conditions have both an underlying etiology and multiple body system manifestations due to the underlying etiology. For such conditions, the ICD-10-CM has a coding convention that requires the underlying condition be sequenced first followed by the manifestation. Wherever such a combination exists, there is a “use additional code” note at the etiology code, and a “code first” note at the manifestation code. These instructional notes indicate the proper sequencing order of the codes (etiology followed by manifestation). In accordance with the ICD-10-CM Official Guidelines for Coding and Reporting, when a primary (psychiatric) diagnosis code has a “code first” note, the provider would follow the instructions in the ICD-10-CM text. The submitted claim goes through the CMS processing system, which will identify the primary diagnosis code as non-psychiatric and search the secondary codes for a psychiatric code to assign a DRG code for adjustment. The system will continue to search the secondary codes for those that are appropriate for comorbidity adjustment.

    For more information on “code first” policy, please see the November 2004 IPF PPS final rule (69 FR 66945). In the FY 2015 IPF PPS final rule, we provided a “code first” table for reference that highlights the same or similar manifestation codes where the “code first” instructions apply in ICD-10-CM that were present in ICD-9-CM (79 FR 46009). In the FY 2018 update to the ICD-10-CM/PCS code sets, there were a number of codes deleted from the IPF Code First list for diagnosis codes F0280 and F0281. These changes are shown in Addendum B of this notice with comment period.

    b. Payment for Comorbid Conditions

    The intent of the comorbidity adjustments is to recognize the increased costs associated with comorbid conditions by providing additional payments for certain existing medical or psychiatric conditions that are expensive to treat. In the May 2011 IPF PPS final rule (76 FR 26451 through 26452), we explained that the IPF PPS includes 17 comorbidity categories and identified the new, revised, and deleted ICD-9-CM diagnosis codes that generate a comorbid condition payment adjustment under the IPF PPS for RY 2012 (76 FR 26451).

    Comorbidities are specific patient conditions that are secondary to the patient's principal diagnosis and that require treatment during the stay. Diagnoses that relate to an earlier episode of care and have no bearing on the current hospital stay are excluded and must not be reported on IPF claims. Comorbid conditions must exist at the time of admission or develop subsequently, and affect the treatment received, length of stay (LOS), or both treatment and LOS.

    For each claim, an IPF may receive only one comorbidity adjustment within a comorbidity category, but it may receive an adjustment for more than one comorbidity category. Current billing instructions for discharge claims, on or after October 1, 2015, require IPFs to enter the complete ICD-10-CM codes for up to 24 additional diagnoses if they co-exist at the time of admission, or develop subsequently and impact the treatment provided.

    The comorbidity adjustments were determined based on the regression analysis using the diagnoses reported by IPFs in FY 2002. The principal diagnoses were used to establish the DRG adjustments and were not accounted for in establishing the comorbidity category adjustments, except where ICD-9-CM “code first” instructions apply. In a “code first” situation, the submitted claim goes through the CMS processing system, which will identify the primary diagnosis code as non-psychiatric and search the secondary codes for a psychiatric code to assign a DRG code for adjustment. The system will continue to search the secondary codes for those that are appropriate for comorbidity adjustment.

    As noted previously, it is our policy to maintain the same diagnostic coding set for IPFs that is used under the IPPS for providing the same psychiatric care. The 17 comorbidity categories formerly defined using ICD-9-CM codes were converted to ICD-10-CM/PCS in the FY 2015 IPF PPS final rule (79 FR 45947 through 45955). The goal for converting the comorbidity categories is referred to as replication, meaning that the payment adjustment for a given patient encounter is the same after ICD-10-CM implementation as it would be if the same record had been coded in ICD-9-CM and submitted prior to ICD-10-CM/PCS implementation on October 1, 2015. All conversion efforts were made with the intent of achieving this goal. For FY 2018, we will use the same comorbidity adjustment factors in effect in FY 2017, which are found in Addendum A of this notice with comment period.

    We have updated the ICD-10-CM/PCS codes which are associated with the existing IPF PPS comorbidity categories, based upon the FY 2018 update to the ICD-10-CM/PCS code set. The FY 2018 ICD-10-CM/PCS updates included additions or deletions which affected the comorbidity categories for Oncology (both the Treatment and Procedures lists). These updates are detailed in Addendum B of this notice.

    In accordance with the policy established in the FY 2015 IPF PPS final rule (79 FR 45949 through 45952), we reviewed all new FY 2018 ICD-10-CM codes to remove site unspecified codes from the new FY 2018 ICD-10-CM/PCS codes in instances where more specific codes are available. There were no new FY 2018 ICD-10-CM/PCS codes that were site unspecified. Please see Addendum B of this notice with comment period for a table of changes to the ICD-10-CM/PCS codes which affect FY 2018 IPF PPS comorbidity categories.

    3. Patient Age Adjustments

    As explained in the November 2004 IPF PPS final rule (69 FR 66922), we analyzed the impact of age on per diem cost by examining the age variable (range of ages) for payment adjustments. In general, we found that the cost per day increases with age. The older age groups are more costly than the under 45 age group, the differences in per diem cost increase for each successive age group, and the differences are statistically significant. For FY 2018, we will use the patient age adjustments currently in effect in FY 2017, as shown in Addendum A of this notice with comment period.

    4. Variable per Diem Adjustments

    We explained in the November 2004 IPF PPS final rule (69 FR 66946) that the regression analysis indicated that per diem cost declines as the LOS increases. The variable per diem adjustments to the federal per diem base rate account for ancillary and administrative costs that occur disproportionately in the first days after admission to an IPF. We used a regression analysis to estimate the average differences in per diem cost among stays of different lengths. As a result of this analysis, we established variable per diem adjustments that begin on day 1 and decline gradually until day 21 of a patient's stay. For day 22 and thereafter, the variable per diem adjustment remains the same each day for the remainder of the stay. However, the adjustment applied to day 1 depends upon whether the IPF has a qualifying ED. If an IPF has a qualifying ED, it receives a 1.31 adjustment factor for day 1 of each stay. If an IPF does not have a qualifying ED, it receives a 1.19 adjustment factor for day 1 of the stay. The ED adjustment is explained in more detail in section III.D.4 of this notice with comment period.

    For FY 2018, we will use the variable per diem adjustment factors currently in effect as shown in Addendum A of this notice with comment period. A complete discussion of the variable per diem adjustments appears in the November 2004 IPF PPS final rule (69 FR 66946).

    D. Updates to the IPF PPS Facility-Level Adjustments

    The IPF PPS includes facility-level adjustments for the wage index, IPFs located in rural areas, teaching IPFs, cost of living adjustments for IPFs located in Alaska and Hawaii, and IPFs with a qualifying ED.

    1. Wage Index Adjustment a. Background

    As discussed in the May 2006 IPF PPS final rule (71 FR 27061) and in the May 2008 (73 FR 25719) and May 2009 (74 FR 20373) IPF PPS notices, in order to provide an adjustment for geographic wage levels, the labor-related portion of an IPF's payment is adjusted using an appropriate wage index. Currently, an IPF's geographic wage index value is determined based on the actual location of the IPF in an urban or rural area, as defined in § 412.64(b)(1)(ii)(A) and (C).

    b. Updated Wage Index for FY 2018

    Since the inception of the IPF PPS, we have used the pre-floor, pre-reclassified acute care hospital wage index in developing a wage index to be applied to IPFs, because there is not an IPF-specific wage index available. We believe that IPFs compete in the same labor markets as acute care hospitals, so the pre-floor, pre-reclassified hospital wage index should reflect IPF labor costs. As discussed in the May 2006 IPF PPS final rule for FY 2007 (71 FR 27061 through 27067), under the IPF PPS, the wage index is calculated using the IPPS wage index for the labor market area in which the IPF is located, without taking into account geographic reclassifications, floors, and other adjustments made to the wage index under the IPPS. For a complete description of these IPPS wage index adjustments, please see the CY 2013 IPPS/LTCH PPS final rule (77 FR 53365 through 53374). For FY 2018, we will continue to apply the most recent hospital wage index (the FY 2017 pre-floor, pre-reclassified hospital wage index, which is the most appropriate index as it best reflects the variation in local labor costs of IPFs in the various geographic areas) using the most recent hospital wage data (data from hospital cost reports for the cost reporting period beginning during FY 2013) without any geographic reclassifications, floors, or other adjustments. We apply the FY 2018 IPF PPS wage index to payments beginning October 1, 2017.

    We apply the wage index adjustment to the labor-related portion of the federal rate, which changed from 75.1 percent in FY 2017 to 75.0 percent in FY 2018. This percentage reflects the labor-related share of the 2012-based IPF market basket for FY 2018 (see section III.A.3 of this notice with comment period).

    c. OMB Bulletins

    OMB publishes bulletins regarding Core-Based Statistical Area (CBSA) changes, including changes to CBSA numbers and titles. In the May 2006 IPF PPS final rule for RY 2007 (71 FR 27061 through 27067), we adopted the changes discussed in the Office of Management and Budget (OMB) Bulletin No. 03-04 (June 6, 2003), which announced revised definitions for Metropolitan Statistical Areas (MSAs), and the creation of Micropolitan Statistical Areas and Combined Statistical Areas. In adopting the OMB CBSA geographic designations in RY 2007, we did not provide a separate transition for the CBSA-based wage index since the IPF PPS was already in a transition period from TEFRA payments to PPS payments.

    In the May 2008 IPF PPS notice, we incorporated the CBSA nomenclature changes published in the most recent OMB bulletin that applies to the hospital wage index used to determine the current IPF PPS wage index and stated that we expect to continue to do the same for all the OMB CBSA nomenclature changes in future IPF PPS rules and notices, as necessary (73 FR 25721). The OMB bulletins may be accessed online at https://www.whitehouse.gov/omb/bulletins_default/.

    In accordance with our established methodology, we have historically adopted any CBSA changes that are published in the OMB bulletin that corresponds with the hospital wage index used to determine the IPF PPS wage index. For the FY 2015 IPF wage index, we used the FY 2014 pre-floor, pre-reclassified hospital wage index to adjust the IPF PPS payments. On February 28, 2013, OMB issued OMB Bulletin No. 13-01, which established revised delineations for MSAs, Micropolitan Statistical Areas, and Combined Statistical Areas, and provided guidance on the use of the delineations of these statistical areas. A copy of this bulletin may be obtained at https://www.whitehouse.gov/omb/information-for-agencies/bulletins.

    Because the FY 2014 pre-floor, pre-reclassified hospital wage index was finalized prior to the issuance of this Bulletin, the FY 2015 IPF PPS wage index, which was based on the FY 2014 pre-floor, pre-reclassified hospital wage index, did not reflect OMB's new area delineations based on the 2010 Census. According to OMB, “[t]his bulletin provides the delineations of all Metropolitan Statistical Areas, Metropolitan Divisions, Micropolitan Statistical Areas, Combined Statistical Areas, and New England City and Town Areas in the United States and Puerto Rico based on the standards published on June 28, 2010, in the Federal Register (75 FR 37246 through 37252) and Census Bureau data.” These OMB Bulletin changes are reflected in the FY 2015 pre-floor, pre-reclassified hospital wage index, upon which the FY 2016 IPF wage index was based. We adopted these new OMB CBSA delineations in the FY 2016 IPF PPS wage index and subsequent IPF wage indexes.

    Generally, OMB issues major revisions to statistical areas every 10 years, based on the results of the decennial census. However, OMB occasionally issues minor updates and revisions to statistical areas in the years between the decennial censuses. On July 15, 2015, OMB issued OMB Bulletin No. 15-01, which provides minor updates to, and supersedes, OMB Bulletin No. 13-01 that was issued on February 28, 2013. The attachment to OMB Bulletin No. 15-01 provides detailed information on the update to statistical areas since February 28, 2013. The updates provided in the attachment to OMB Bulletin No. 15-01 are based on the application of the 2010 Standards for Delineating Metropolitan and Micropolitan Statistical Areas to Census Bureau population estimates for July 1, 2012 and July 1, 2013. The complete list of statistical areas incorporating these changes is provided in OMB Bulletin No. 15-01. A copy of this bulletin may be obtained at https://www.whitehouse.gov/omb/information-for-agencies/bulletins.

    The bulletin establishes revised delineations for the Nation's Metropolitan Statistical Areas, Micropolitan Statistical Areas, and Combined Statistical Areas. The bulletin also provides delineations of Metropolitan Divisions as well as delineations of New England City and Town Areas. OMB Bulletin No. 15-01 made the following changes that are relevant to the FY 2018 IPF wage index:

    • Garfield County, OK, with principal city Enid, OK, which was a Micropolitan (geographically rural) area, now qualifies as an urban new CBSA 21420 called Enid, OK.

    • The county of Bedford City, VA, a component of the Lynchburg, VA CBSA 31340, changed to town status and is added to Bedford County. Therefore, the county of Bedford City (SSA State county code 49088, FIPS State County Code 51515) is now part of the county of Bedford, VA (SSA State county code 49090, FIPS State County Code 51019). However, the CBSA remains Lynchburg, VA, 31340.

    • The name of Macon, GA, CBSA 31420, as well as a principal city of the Macon-Warner Robins, GA combined statistical area, is now Macon-Bibb County, GA. The CBSA code remains as 31420.

    In accordance with our longstanding policy, the IPF PPS continues to use the latest labor market area delineations available as soon as is reasonably possible to maintain a more accurate and up-to-date payment system that reflects the reality of population shifts and labor market conditions. As discussed in the FY 2017 IPPS and Long-Term Care Hospital (LTCH) PPS final rule (81 FR 56913), these updated labor market area definitions from OMB Bulletin 15-01 were implemented under the IPPS beginning on October 1, 2016 (FY 2017). Therefore, we are implementing these revisions for the IPF PPS beginning October 1, 2017 (FY 2018), consistent with our historical practice of modeling IPF PPS adoption of the labor market area delineations after IPPS adoption of these delineations.

    In FY 2016, we applied a 1-year transition period when implementing the OMB delineations described in the February 28, 2013 OMB Bulletin No. 13-01, as this bulletin contained a number of significant changes that resulted in substantial payment implications for some IPF providers. That 1-year transition consisted of a blended wage index for all providers, consisting of a blend of fifty percent of the FY 2016 IPF wage index using the existing OMB delineations and fifty percent of the FY 2016 IPF wage index using the updated OMB delineations from the February 28, 2013 OMB Bulletin (80 FR 46682 through 46689). For FY 2018, we are incorporating the CBSA changes published in the July 15, 2015 OMB Bulletin No. 15-01 into the FY 2018 IPF wage index without a transition period, as we anticipate that these changes will affect a single IPF provider located in Garfield County, OK, and will increase this provider's wage index value by almost 14 percent.

    In summary, as the changes made in the July 15, 2015 OMB Bulletin 15-01 are minor and do not have a large effect on a substantial number of providers, we are adopting these updates without any transition period. Therefore, the FY 2018 IPF wage index and subsequent IPF wage indices will be based solely on the new OMB CBSA delineations in OMB Bulletin No. 15-01, without any transitions. The final FY 2018 IPF wage index is located on the CMS Web site at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientPsychFacilPPS/WageIndex.html.

    d. Adjustment for Rural Location

    In the November 2004 IPF PPS final rule, we provided a 17 percent payment adjustment for IPFs located in a rural area. This adjustment was based on the regression analysis, which indicated that the per diem cost of rural facilities was 17 percent higher than that of urban facilities after accounting for the influence of the other variables included in the regression. For FY 2018, we will continue to apply a 17 percent payment adjustment for IPFs located in a rural area as defined at § 412.64(b)(1)(ii)(C). A complete discussion of the adjustment for rural locations appears in the November 2004 IPF PPS final rule (69 FR 66954).

    As noted in section III.D.1.c of this notice with comment period, we adopted the February 28, 2013 OMB updates to CBSA delineations in the FY 2016 IPF PPS transitional wage index. Adoption of the updated CBSAs changed the status of 37 IPF providers designated as “rural” in FY 2015 to “urban” for FY 2016 and subsequent FYs. As such, these 37 newly urban providers no longer receive the 17 percent rural adjustment.

    In the FY 2016 IPF PPS final rule, we implemented a budget-neutral 3-year phase-out of the rural adjustment for the existing FY 2015 rural IPFs that became urban in FY 2016 and that experienced a loss in payments due to changes from the new CBSA delineations (80 FR 46689 to 46690). This policy allowed rural IPFs that were classified as urban in FY 2016 to receive two-thirds of the IPF PPS rural adjustment for FY 2016. For FY 2017, these IPFs will receive one-third of the IPF PPS rural adjustment. For FY 2018 (and subsequent years), these IPFs will not receive any rural adjustment. FY 2018 is the third year of the 3-year rural adjustment phase-out. Therefore, these IPFs that were classified as rural in FY 2015, but were changed to urban in FY 2016 as a result of the February 28, 2013 OMB CBSA changes, will receive no rural adjustment in FY 2018 or subsequent years.

    Additionally, as noted previously in section III.D.1.c. of this notice with comment period, the July 15, 2015 OMB Bulletin No. 15-01 changed Garfield County, Oklahoma from rural status to urban status, under new CBSA 21420. There is a single IPF in this county, which will lose the 17 percent rural adjustment in FY 2018. However, as noted in section III.D.1.c of this notice with comment period, this provider will experience an increase of nearly 14 percent in their FY 2018 wage index value. As this provider is not expected to experience as steep of a reduction in payments as did the majority of IPFs for which a phase-out of the rural adjustment was implemented in FY 2016 (80 FR 43689 through 46690), we do not believe it is appropriate or necessary to adopt a rural phase-out policy for this provider.

    e. Budget Neutrality Adjustment

    Changes to the wage index are made in a budget-neutral manner so that updates do not increase expenditures. Therefore, for FY 2018, we will continue to apply a budget-neutrality adjustment in accordance with our existing budget-neutrality policy. This policy requires us to update the wage index in such a way that total estimated payments to IPFs for FY 2018 are the same with or without the changes (that is, in a budget-neutral manner) by applying a budget neutrality factor to the IPF PPS rates. We use the following steps to ensure that the rates reflect the update to the wage indexes (based on the FY 2013 hospital cost report data) and the labor-related share in a budget-neutral manner:

    Step 1. Simulate estimated IPF PPS payments, using the FY 2017 IPF wage index values (available on the CMS Web site) and labor-related share (as published in the FY 2017 IPF PPS notice (81 FR 50506, and 50508 to 50509)).

    Step 2. Simulate estimated IPF PPS payments using the FY 2018 IPF wage index values (available on the CMS Web site) and labor-related share (based on the latest available data as discussed previously).

    Step 3. Divide the amount calculated in step 1 by the amount calculated in step 2. The resulting quotient is the FY 2018 budget-neutral wage adjustment factor of 1.0006.

    Step 4. Apply the FY 2018 budget-neutral wage adjustment factor from step 3 to the FY 2017 IPF PPS per diem rate after the application of the market basket update described in section III.A.2 of this notice with comment period, to determine the FY 2018 IPF PPS per diem rate.

    2. Teaching Adjustment

    In the November 2004 IPF PPS final rule, we implemented regulations at § 412.424(d)(1)(iii) to establish a facility-level adjustment for IPFs that are, or are part of, teaching hospitals. The teaching adjustment accounts for the higher indirect operating costs experienced by hospitals that participate in graduate medical education (GME) programs. The payment adjustments are made based on the ratio of the number of full-time equivalent (FTE) interns and residents training in the IPF and the IPF's average daily census (ADC).

    Medicare makes direct GME payments (for direct costs such as resident and teaching physician salaries, and other direct teaching costs) to all teaching hospitals including those paid under a PPS, and those paid under the TEFRA rate-of-increase limits. These direct GME payments are made separately from payments for hospital operating costs and are not part of the IPF PPS. The direct GME payments do not address the estimated higher indirect operating costs teaching hospitals may face.

    The results of the regression analysis of FY 2002 IPF data established the basis for the payment adjustments included in the November 2004 IPF PPS final rule. The results showed that the indirect teaching cost variable is significant in explaining the higher costs of IPFs that have teaching programs. We calculated the teaching adjustment based on the IPF's “teaching variable,” which is one plus the ratio of the number of FTE residents training in the IPF (subject to limitations described below) to the IPF's ADC.

    We established the teaching adjustment in a manner that limited the incentives for IPFs to add FTE residents for the purpose of increasing their teaching adjustment. We imposed a cap on the number of FTE residents that may be counted for purposes of calculating the teaching adjustment. The cap limits the number of FTE residents that teaching IPFs may count for the purpose of calculating the IPF PPS teaching adjustment, not the number of residents teaching institutions can hire or train. We calculated the number of FTE residents that trained in the IPF during a “base year” and used that FTE resident number as the cap. An IPF's FTE resident cap is ultimately determined based on the final settlement of the IPF's most recent cost report filed before November 15, 2004 (publication date of the IPF PPS final rule). A complete discussion of the temporary adjustment to the FTE cap to reflect residents added due to hospital closure and by residency program appears in the January 27, 2011 IPF PPS proposed rule (76 FR 5018 through 5020) and the May 6, 2011 IPF PPS final rule (76 FR 26453 through 26456).

    In the regression analysis, the logarithm of the teaching variable had a coefficient value of 0.5150. We converted this cost effect to a teaching payment adjustment by treating the regression coefficient as an exponent and raising the teaching variable to a power equal to the coefficient value. We note that the coefficient value of 0.5150 was based on the regression analysis holding all other components of the payment system constant. A complete discussion of how the teaching adjustment was calculated appears in the November 2004 IPF PPS final rule (69 FR 66954 through 66957) and the May 2008 IPF PPS notice (73 FR 25721). As with other adjustment factors derived through the regression analysis, we do not plan to rerun the teaching adjustment factors in the regression analysis until we more fully analyze IPF PPS data. Therefore, in this FY 2018 notice, we will continue to retain the coefficient value of 0.5150 for the teaching adjustment to the federal per diem base rate.

    3. Cost of Living Adjustment for IPFs Located in Alaska and Hawaii

    The IPF PPS includes a payment adjustment for IPFs located in Alaska and Hawaii based upon the county in which the IPF is located. As we explained in the November 2004 IPF PPS final rule, the FY 2002 data demonstrated that IPFs in Alaska and Hawaii had per diem costs that were disproportionately higher than other IPFs. Other Medicare prospective payment systems (for example: The IPPS and LTCH PPS) adopted a cost of living adjustment (COLA) to account for the cost differential of care furnished in Alaska and Hawaii.

    We analyzed the effect of applying a COLA to payments for IPFs located in Alaska and Hawaii. The results of our analysis demonstrated that a COLA for IPFs located in Alaska and Hawaii would improve payment equity for these facilities. As a result of this analysis, we provided a COLA in the November 2004 IPF PPS final rule.

    A COLA for IPFs located in Alaska and Hawaii is made by multiplying the non-labor-related portion of the federal per diem base rate by the applicable COLA factor based on the COLA area in which the IPF is located.

    The COLA factors through 2009 (before being reduced by locality payments) are published on the Office of Personnel Management (OPM) Web site (https://www.opm.gov/oca/cola/rates.asp).

    We note that the COLA areas for Alaska are not defined by county as are the COLA areas for Hawaii. In 5 CFR 591.207, the OPM established the following COLA areas:

    • City of Anchorage, and 80-kilometer (50-mile) radius by road, as measured from the federal courthouse.

    • City of Fairbanks, and 80-kilometer (50-mile) radius by road, as measured from the federal courthouse.

    • City of Juneau, and 80-kilometer (50-mile) radius by road, as measured from the federal courthouse.

    • Rest of the State of Alaska.

    As stated in the November 2004 IPF PPS final rule, we update the COLA factors according to updates established by the OPM. However, sections 1911 through 1919 of the Nonforeign Area Retirement Equity Assurance Act, as contained in subtitle B of title XIX of the National Defense Authorization Act (NDAA) for FY 2010 (Pub. L. 111-84, October 28, 2009), transitions the Alaska and Hawaii COLAs to locality pay. Under section 1914 of NDAA, locality pay was phased in over a 3-year period beginning in January 2010, with COLA rates frozen as of the date of enactment, October 28, 2009, and then proportionately reduced to reflect the phase-in of locality pay.

    When we published the proposed COLA factors in the January 2011 IPF PPS proposed rule (76 FR 4998), we inadvertently selected the FY 2010 COLA rates, which had been reduced to account for the phase-in of locality pay. We did not intend to propose the reduced COLA rates because that would have understated the adjustment. Since the 2009 COLA rates did not reflect the phase-in of locality pay, we finalized the FY 2009 COLA rates for RY 2010 through RY 2014.

    In the FY 2013 IPPS/LTCH final rule (77 FR 53700 through 53701), we established a new methodology to update the COLA factors for Alaska and Hawaii, and adopted this methodology for the IPF PPS in the FY 2015 IPF final rule (79 FR 45958 through 45960). We adopted this new COLA methodology for the IPF PPS because IPFs are hospitals with a similar mix of commodities and services. We think it is appropriate to have a consistent policy approach with that of other hospitals in Alaska and Hawaii. Therefore, the IPF COLAs for FY 2015 through FY 2017 were the same as those applied under the IPPS in those years. For the FY 2018 IPF COLAs, we are continuing to adopt the COLA factors implemented in the FY 2018 IPPS/LTCH PPS final rule using the methodology finalized in the FY 2013 IPPS/LTCH final rule and implemented for the FY 2014 IPPS update. Also, as finalized in the FY 2013 IPPS/LTCH PPS final rule (77 FR 53700 and 53701), the COLA updates are determined every four years, when the IPPS market basket labor-related share is updated during rebasing. Because the labor-related share of the IPPS market basket is being updated for FY 2018, the COLA factors are being updated in FY 2018 IPPS/LTCH rulemaking. As such, we are also updating the IPF PPS COLA factors for FY 2018.

    Specifically, the FY 2018 IPPS/LTCH PPS final rule updates the 2009 OPM COLA factors (as these are the last COLA factors OPM published prior to transitioning from COLAs to locality pay) by a comparison of the growth in the Consumer Price Indices (CPIs) for Anchorage, AK and Honolulu, HI relative to the growth in the CPI for the average U.S. city as published by the Bureau of Labor Statistics (BLS). Because BLS publishes CPI data for only Anchorage and Honolulu, using the methodology we finalized in the FY 2013 IPPS/LTCH PPS final rule, we use the comparison of the growth in the overall CPI relative to the growth in the CPI for those cities to update the COLA factors for all areas in Alaska and Hawaii, respectively. We believe that the relative price differences between these cities and the United States (as measured by the CPIs mentioned previously) are appropriate proxies for the relative price differences between the “other areas” of Alaska and Hawaii and the United States.

    BLS publishes the CPI for All Items for Anchorage, Honolulu, and for the average U.S. city. However, consistent with the methodology finalized in the FY 2013 IPPS/LTCH PPS final rule, in the FY 2018 IPPS/LTCH PPS final rule, reweighted CPIs were created for each of the respective areas to reflect the underlying composition of the IPPS market basket nonlabor-related share. The current composition of the CPI for All Items for all of the respective areas is approximately 40 percent commodities and 60 percent services. However, the IPPS nonlabor-related share is comprised of a different mix of commodities and services. Therefore, reweighted indexes were created for Anchorage, Honolulu, and the average U.S. city and use the respective CPI commodities index and CPI services index using the approximate 55 percent commodities/45 percent services shares obtained from the updated 2014-based IPPS market basket.

    Reweighted indexes were created using BLS data for 2009 through 2016, which is the most recent data available at the time of the FY 2018 IPPS/LTCH final rule. In the FY 2014 IPPS/LTCH PPS final rule (78 FR 50985 through 50987), reweighted indexes were created based on the FY 2010-based IPPS market basket (which was adopted for the FY 2014 IPPS update) and BLS data for 2009 through 2012 (the most recent BLS data at the time of the FY 2014 IPPS/LTCH PPS rulemaking). We continue to believe this methodology is appropriate for IPFs because we continue to make a COLA for IPFs located in Alaska and Hawaii by multiplying the nonlabor-related portion of the per diem amount by a COLA factor.

    Under the COLA factor update methodology established in the FY 2013 IPPS/LTCH final rule, CMS exercised its discretionary authority to adjust payments to hospitals located in Alaska and Hawaii by incorporating a 25 percent cap on the CPI-updated COLA factors. We note that OPM's COLA factors were calculated with a statutorily mandated cap of 25 percent, and the IPPS has exercised discretionary authority to adjust Alaska and Hawaii payments by incorporating this cap. Because the IPF PPS adopted the IPPS COLA factor update methodology in FY 2015 rulemaking, the IPF PPS also continues to use such a cap for FY 2018.

    The COLA factors that we are establishing for FY 2018 to adjust the nonlabor-related portion of the per diem amount for IPFs located in Alaska and Hawaii are shown in Table 1. For comparison purposes, we also are showing the FY 2015 through FY 2017 COLA factors.

    Table 1—Comparison of IPF PPS Cost-of-Living Adjustment Factors: IPFs Located in Alaska and Hawaii Area FY 2015 through 2017 FY 2018 Alaska: City of Anchorage and 80-kilometer (50-mile) radius by road 1.23 1.25 City of Fairbanks and 80-kilometer (50-mile) radius by road 1.23 1.25 City of Juneau and 80-kilometer (50-mile) radius by road 1.23 1.25 Rest of Alaska 1.25 1.25 Hawaii: City and County of Honolulu 1.25 1.25 County of Hawaii 1.19 1.21 County of Kauai 1.25 1.25 County of Maui and County of Kalawao 1.25 1.25

    As noted in the FY 2018 IPPS/LTCH PPS final rule, the reweighted CPI for Anchorage, AK grew faster than the reweighted CPI for the average U.S. city over the 2009 to 2016 time period, at 12.4 percent and 10.5 percent, respectively. As a result, for FY 2018, COLA factors for the City of Anchorage, City of Fairbanks, and City of Juneau were calculated to be 1.25 compared to the FY 2017 COLA factor of 1.23. For FY 2018, a COLA factor of 1.27 was calculated for the Rest of Alaska compared to the FY 2017 COLA factor of 1.25. However, as stated previously, we are applying the methodology finalized in the FY 2013 IPPS/LTCH final rule and adopted in IPF PPS FY 2015 rulemaking to incorporate a cap of 1.25 for the rest of Alaska.

    Similarly, the reweighted CPI for Honolulu, HI grew faster than the reweighted CPI for the average U.S. city over the 2009 to 2016 time period, at 13.7 percent and 10.5 percent, respectively. As a result, for FY 2018, COLA factors were calculated for the City and County of Honolulu, County of Kauai, County of Maui, and County of Kalawao to be 1.29, compared to the FY 2017 COLA factor of 1.25 (which was based on OPM's published COLA factors for 2009, as described previously). However, as stated previously, we are applying the methodology finalized in the FY 2013 IPPS/LTCH PPS final rule and adopted in IPF PPS FY 2015 rulemaking to incorporate a cap of 1.25 for these areas. In addition, the COLA factor for the County of Hawaii for FY 2018 was calculated to be 1.21 compared to the FY 2017 COLA factor of 1.19.

    The IPF PPS COLA factors for FY 2018 are also shown in Addendum A of this notice with comment period.

    4. Adjustment for IPFs With a Qualifying Emergency Department (ED)

    The IPF PPS includes a facility-level adjustment for IPFs with qualifying EDs. We provide an adjustment to the federal per diem base rate to account for the costs associated with maintaining a full-service ED. The adjustment is intended to account for ED costs incurred by a freestanding psychiatric hospital with a qualifying ED or a distinct part psychiatric unit of an acute care hospital or a CAH, for preadmission services otherwise payable under the Medicare Outpatient Prospective Payment System (OPPS), furnished to a beneficiary on the date of the beneficiary's admission to the hospital and during the day immediately preceding the date of admission to the IPF (see § 413.40(c)(2)), and the overhead cost of maintaining the ED. This payment is a facility-level adjustment that applies to all IPF admissions (with one exception described below), regardless of whether a particular patient receives preadmission services in the hospital's ED.

    The ED adjustment is incorporated into the variable per diem adjustment for the first day of each stay for IPFs with a qualifying ED. Those IPFs with a qualifying ED receive an adjustment factor of 1.31 as the variable per diem adjustment for day 1 of each patient stay. If an IPF does not have a qualifying ED, it receives an adjustment factor of 1.19 as the variable per diem adjustment for day 1 of each patient stay.

    The ED adjustment is made on every qualifying claim except as described below. As specified in § 412.424(d)(1)(v)(B), the ED adjustment is not made when a patient is discharged from an acute care hospital or CAH and admitted to the same hospital's or CAH's psychiatric unit. We clarified in the November 2004 IPF PPS final rule (69 FR 66960) that an ED adjustment is not made in this case because the costs associated with ED services are reflected in the DRG payment to the acute care hospital or through the reasonable cost payment made to the CAH.

    Therefore, when patients are discharged from an acute care hospital or CAH and admitted to the same hospital or CAH's psychiatric unit, the IPF receives the 1.19 adjustment factor as the variable per diem adjustment for the first day of the patient's stay in the IPF. For FY 2018, we will continue to retain the 1.31 adjustment factor for IPFs with qualifying EDs. A complete discussion of the steps involved in the calculation of the ED adjustment factor appears in the November 2004 IPF PPS final rule (69 FR 66959 through 66960) and the May 2006 IPF PPS final rule (71 FR 27070 through 27072).

    E. Other Payment Adjustments and Policies 1. Outlier Payment Overview

    The IPF PPS includes an outlier adjustment to promote access to IPF care for those patients who require expensive care and to limit the financial risk of IPFs treating unusually costly patients. In the November 2004 IPF PPS final rule, we implemented regulations at § 412.424(d)(3)(i) to provide a per-case payment for IPF stays that are extraordinarily costly. Providing additional payments to IPFs for extremely costly cases strongly improves the accuracy of the IPF PPS in determining resource costs at the patient and facility level. These additional payments reduce the financial losses that would otherwise be incurred in treating patients who require more costly care and, therefore, reduce the incentives for IPFs to under-serve these patients.

    We make outlier payments for discharges in which an IPF's estimated total cost for a case exceeds a fixed dollar loss threshold amount (multiplied by the IPF's facility-level adjustments) plus the federal per diem payment amount for the case.

    In instances when the case qualifies for an outlier payment, we pay 80 percent of the difference between the estimated cost for the case and the adjusted threshold amount for days 1 through 9 of the stay (consistent with the median LOS for IPFs in FY 2002), and 60 percent of the difference for day 10 and thereafter. We established the 80 percent and 60 percent loss sharing ratios because we were concerned that a single ratio established at 80 percent (like other Medicare PPSs) might provide an incentive under the IPF per diem payment system to increase LOS in order to receive additional payments.

    After establishing the loss sharing ratios, we determined the current fixed dollar loss threshold amount through payment simulations designed to compute a dollar loss beyond which payments are estimated to meet the 2 percent outlier spending target. Each year when we update the IPF PPS, we simulate payments using the latest available data to compute the fixed dollar loss threshold so that outlier payments represent 2 percent of total projected IPF PPS payments.

    2. Update to the Outlier Fixed Dollar Loss Threshold Amount

    In accordance with the update methodology described in § 412.428(d), we are updating the fixed dollar loss threshold amount used under the IPF PPS outlier policy. Based on the regression analysis and payment simulations used to develop the IPF PPS, we established a 2 percent outlier policy, which strikes an appropriate balance between protecting IPFs from extraordinarily costly cases while ensuring the adequacy of the federal per diem base rate for all other cases that are not outlier cases.

    Based on an analysis of the latest available data (the December 2016 update of FY 2016 IPF claims) and rate increases, we believe it is necessary to update the fixed dollar loss threshold amount in order to maintain an outlier percentage that equals 2 percent of total estimated IPF PPS payments. To update the IPF outlier threshold amount for FY 2018, we used FY 2016 claims data and the same methodology that we used to set the initial outlier threshold amount in the May 2006 IPF PPS final rule (71 FR 27072 and 27073), which is also the same methodology that we used to update the outlier threshold amounts for years 2008 through 2017. Based on an analysis of these updated data, we estimate that IPF outlier payments as a percentage of total estimated payments are approximately 2.26 percent in FY 2017. Therefore, we will update the outlier threshold amount to $11,425 to maintain estimated outlier payments at 2 percent of total estimated aggregate IPF payments for FY 2018.

    3. Update to IPF Cost-to-Charge Ratio Ceilings

    Under the IPF PPS, an outlier payment is made if an IPF's cost for a stay exceeds a fixed dollar loss threshold amount plus the IPF PPS amount. In order to establish an IPF's cost for a particular case, we multiply the IPF's reported charges on the discharge bill by its overall cost-to-charge ratio (CCR). This approach to determining an IPF's cost is consistent with the approach used under the IPPS and other PPSs. In the June 2003 IPPS final rule (68 FR 34494), we implemented changes to the IPPS policy used to determine CCRs for acute care hospitals, because we became aware that payment vulnerabilities resulted in inappropriate outlier payments. Under the IPPS, we established a statistical measure of accuracy for CCRs in order to ensure that aberrant CCR data did not result in inappropriate outlier payments.

    As we indicated in the November 2004 IPF PPS final rule (69 FR 66961), because we believe that the IPF outlier policy is susceptible to the same payment vulnerabilities as the IPPS, we adopted a method to ensure the statistical accuracy of CCRs under the IPF PPS. Specifically, we adopted the following procedure in the November 2004 IPF PPS final rule: We calculated two national ceilings, one for IPFs located in rural areas and one for IPFs located in urban areas. We computed the ceilings by first calculating the national average and the standard deviation of the CCR for both urban and rural IPFs using the most recent CCRs entered in the CY 2017 Provider Specific File.

    To determine the rural and urban ceilings, we multiplied each of the standard deviations by 3 and added the result to the appropriate national CCR average (either rural or urban). The upper threshold CCR for IPFs in FY 2018 is 1.9634 for rural IPFs, and 1.7071 for urban IPFs, based on CBSA-based geographic designations. If an IPF's CCR is above the applicable ceiling, the ratio is considered statistically inaccurate, and we assign the appropriate national (either rural or urban) median CCR to the IPF.

    We apply the national CCRs to the following situations:

    • New IPFs that have not yet submitted their first Medicare cost report. We continue to use these national CCRs until the facility's actual CCR can be computed using the first tentatively or final settled cost report.

    • IPFs whose overall CCR is in excess of three standard deviations above the corresponding national geometric mean (that is, above the ceiling).

    • Other IPFs for which the Medicare Administrative Contractor (MAC) obtains inaccurate or incomplete data with which to calculate a CCR.

    We are updating the FY 2018 national median and ceiling CCRs for urban and rural IPFs based on the CCRs entered in the latest available IPF PPS Provider Specific File. Specifically, for FY 2018, to be used in each of the three situations listed previously, using the most recent CCRs entered in the CY 2017 Provider Specific File, we estimate a national median CCR of 0.5930 for rural IPFs and a national median CCR of 0.4420 for urban IPFs. These calculations are based on the IPF's location (either urban or rural) using the CBSA-based geographic designations.

    A complete discussion regarding the national median CCRs appears in the November 2004 IPF PPS final rule (69 FR 66961 through 66964).

    IV. Update on IPF PPS Refinements

    For RY 2012, we identified several areas of concern for future refinement, and we invited comments on these issues in our RY 2012 proposed and final rules. For further discussion of these issues and to review the public comments, we refer readers to the RY 2012 IPF PPS proposed rule (76 FR 4998) and final rule (76 FR 26432).

    We have delayed making refinements to the IPF PPS until we have completed a thorough analysis of IPF PPS data on which to base those refinements. Specifically, we will delay updating the adjustment factors derived from the regression analysis until we have IPF PPS data that include as much information as possible regarding the patient-level characteristics of the population that each IPF serves. We have begun and will continue the necessary analysis to better understand IPF industry practices so that we may refine the IPF PPS in the future, as appropriate.

    As we noted in the FY 2016 IPF PPS final rule (80 FR 46693 to 46694), our preliminary analysis of 2012 to 2013 IPF data found that over 20 percent of IPF stays reported no ancillary costs, such as laboratory and drug costs, in their cost reports, or laboratory or drug charges on their claims. Because we expect that most patients requiring hospitalization for active psychiatric treatment will need drugs and laboratory services, we again remind providers that the IPF PPS per diem payment rate includes the cost of all ancillary services, including drugs and laboratory services. We pay only the IPF for services furnished to a Medicare beneficiary who is an inpatient of that IPF, except for certain professional services, and payments are considered to be payments in full for all inpatient hospital services provided directly or under arrangement (see 42 CFR 412.404(d)), as specified in 42 CFR 409.10.

    We are continuing to analyze data from claims and cost reports that do not include ancillary charges or costs, and will be sharing our findings with the Center for Program Integrity and the Office of Financial Management for further investigation, as the results warrant. Our refinement analysis is dependent on recent precise data for costs, including ancillary costs. We will continue to collect these data and analyze them for both timeliness and accuracy with the expectation that these data will be used in a future refinement. Since we are not making refinements for FY 2018, we will continue to use the existing adjustment factors.

    V. Waiver of Notice and Comment

    We ordinarily publish a notice of proposed rulemaking in the Federal Register to provide a period for public comment before the provisions of a rule take effect. We can waive this procedure, however, if we find good cause that notice and comment procedures are impracticable, unnecessary, or contrary to the public interest and we incorporate a statement of finding and its reasons in the notice.

    We find it is unnecessary to undertake notice and comment rulemaking for this action because the updates in this notice with comment period do not reflect any substantive changes in policy, but merely reflect the application of previously established methodologies. Therefore, under 5 U.S.C 553(b)(3)(B), for good cause, we waive notice and comment procedures.

    VI. Request for Information on CMS Flexibilities and Efficiencies

    CMS is committed to transforming the health care delivery system—and the Medicare program—by putting an additional focus on patient-centered care and working with providers, physicians, and patients to improve outcomes. We seek to reduce burdens for hospitals, physicians, and patients, improve the quality of care, decrease costs, and ensure that patients and their providers and physicians are making the best health care choices possible. These are the reasons we are including this Request for Information in this notice with comment period.

    As we work to maintain flexibility and efficiency throughout the Medicare program, we would like to start a national conversation about improvements that can be made to the health care delivery system that reduce unnecessary burdens for clinicians, other providers, and patients and their families. We aim to increase quality of care, lower costs improve program integrity, and make the health care system more effective, simple and accessible.

    We would like to take this opportunity to invite the public to submit their ideas for regulatory, subregulatory, policy, practice, and procedural changes to better accomplish these goals. Ideas could include payment system redesign, elimination or streamlining of reporting, monitoring and documentation requirements, aligning Medicare requirements and processes with those from Medicaid and other payers, operational flexibility, feedback mechanisms and data sharing that would enhance patient care, support of the physician-patient relationship in care delivery, and facilitation of individual preferences. Responses to this Request for Information could also include recommendations regarding when and how CMS issues regulations and policies and how CMS can simplify rules and policies for beneficiaries, clinicians, physicians, providers, and suppliers. Where practicable, data and specific examples would be helpful. If the proposals involve novel legal questions, analysis regarding CMS' authority is welcome for CMS' consideration. We are particularly interested in ideas for incentivizing organizations and the full range of relevant professionals and paraprofessionals to provide screening, assessment and evidence-based treatment for individuals with opioid use disorder and other substance use disorders, including reimbursement methodologies, care coordination, systems and services integration, use of paraprofessionals including community paramedics and other strategies. We are requesting commenters to provide clear and concise proposals that include data and specific examples that could be implemented within the law.

    We note that this is a Request for Information only. Respondents are encouraged to provide complete but concise responses. This Request for Information is issued solely for information and planning purposes; it does not constitute a Request for Proposal (RFP), applications, proposal abstracts, or quotations. This Request for Information does not commit the U.S. Government to contract for any supplies or services or make a grant award. Further, CMS is not seeking proposals through this Request for Information and will not accept unsolicited proposals. Responders are advised that the U.S. Government will not pay for any information or administrative costs incurred in response to this Request for Information; all costs associated with responding to this Request for Information will be solely at the interested party's expense. We note that not responding to this Request for Information does not preclude participation in any future procurement, if conducted. It is the responsibility of the potential responders to monitor this Request for Information announcement for additional information pertaining to this request. In addition, we note that CMS will not respond to questions about the policy issues raised in this Request for Information. CMS will not respond to comment submissions in response to this Request for Information in the FY 2018 Inpatient Psychiatric Facilities Prospective Payment System—Rate Update notice with comment period. Rather, CMS will actively consider all input as we develop future regulatory proposals or future subregulatory policy guidance. CMS may or may not choose to contact individual responders. Such communications would be for the sole purpose of clarifying statements in the responders' written responses. Contractor support personnel may be used to review responses to this Request for Information. Responses to this notice with comment period are not offers and cannot be accepted by the Government to form a binding contract or issue a grant. Information obtained as a result of this Request for Information may be used by the Government for program planning on a nonattribution basis. Respondents should not include any information that might be considered proprietary or confidential. This Request for Information should not be construed as a commitment or authorization to incur cost for which reimbursement would be required or sought. All submissions become U.S. Government property and will not be returned. CMS may publicly post the public comments received, or a summary of those public comments.

    VII. Collection of Information Requirements

    This notice does not impose any new or revised information collection requirements or burden pertaining to collecting, reporting, recordkeeping, or disclosing information. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

    VIII. Response to Comments

    Because of the large number of public comments we normally receive on Federal Register documents, we are not able to acknowledge or respond to them individually. We will consider all comments we receive by the date and time specified in the “DATES” section of this preamble, and, when we proceed with a subsequent document, we will respond to the comments in the preamble to that document.

    IX. Regulatory Impact Analysis A. Statement of Need

    This notice with comment period updates the prospective payment rates for Medicare inpatient hospital services provided by IPFs for discharges occurring during FY 2018 (October 1, 2017 through September 30, 2018). We are applying the 2012-based IPF market basket increase of 2.6 percent, less the productivity adjustment of 0.6 percentage point as required by 1886(s)(2)(A)(i) of the Act, and further reduced by 0.75 percentage point as required by sections 1886(s)(2)(A)(ii) and 1886(s)(3)(E) of the Act, for a total FY 2018 payment rate update of 1.25 percent. In this notice with comment period, we are also updating the IPF labor-related share and updating the IPF wage index for FY 2018. The rural adjustment phase-out for the small number of rural providers which became urban providers in FY 2016 as a result of FY 2016 changes to CBSA delineations is now in its third and final year, and results in no rural adjustment for the affected providers in FY 2018, or in subsequent years.

    B. Overall Impact

    We have examined the impacts of this notice with comment period as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96 354), section 1102(b) of the Social Security Act, section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 1999), the Congressional Review Act (5 U.S.C. 804(2)) and Executive Order 13771 on Reducing Regulation and Controlling Regulatory Costs (January 30, 2017).

    Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action that is likely to result in a rule: (1) Having an annual effect on the economy of $100 million or more in any 1 year, or adversely and materially affecting a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or state, local or tribal governments or communities (also referred to as “economically significant”); (2) creating a serious inconsistency or otherwise interfering with an action taken or planned by another agency; (3) materially altering the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raising novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order. This notice with comment period is not designated as economically “significant” under section 3(f)(1) of Executive Order 12866.

    We estimate that the total impact of these changes for FY 2018 payments compared to FY 2017 payments will be a net increase of approximately $45 million. This reflects a $55 million increase from the update to the payment rates (+$115 million from the unadjusted second quarter 2017 IGI forecast of the 2012-based IPF market basket of 2.6 percent, -$25 million for the productivity adjustment of 0.6 percentage point, and -$35 million for the other adjustment of 0.75 percentage point), as well as a $10 million decrease as a result of the update to the outlier threshold amount. Outlier payments are estimated to decrease from 2.26 percent in FY 2017 to 2.0 percent of total estimated IPF payments in FY 2018.

    The RFA requires agencies to analyze options for regulatory relief of small entities if a rule has a significant impact on a substantial number of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. Most IPFs and most other providers and suppliers are small entities, either by nonprofit status or having revenues of $7.5 million to $38.5 million or less in any 1 year, depending on industry classification (for details, refer to the SBA Small Business Size Standards found at http://www.sba.gov/sites/default/files/files/Size_Standards_Table.pdf).

    Because we lack data on individual hospital receipts, we cannot determine the number of small proprietary IPFs or the proportion of IPFs' revenue derived from Medicare payments. Therefore, we assume that all IPFs are considered small entities. The Department of Health and Human Services generally uses a revenue impact of 3 to 5 percent as a significance threshold under the RFA.

    As shown in Table 2, we estimate that the overall revenue impact of this notice with comment period on all IPFs is to increase Medicare payments by approximately 0.99 percent. As a result, since the estimated impact of this notice with comment period is a net increase in revenue across almost all categories of IPFs, the Secretary has determined that this notice with comment period will have a positive revenue impact on a substantial number of small entities. MACs are not considered to be small entities. Individuals and states are not included in the definition of a small entity.

    In addition, section 1102(b) of the Social Security Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 604 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a metropolitan statistical area and has fewer than 100 beds. As discussed in detail below, the rates and policies set forth in this notice with comment period will not have an adverse impact on the rural hospitals based on the data of the 277 rural units and 67 rural hospitals in our database of 1,621 IPFs for which data were available. Therefore, the Secretary has determined that this notice with comment period will not have a significant impact on the operations of a substantial number of small rural hospitals.

    Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2017, that threshold is approximately $148 million. This notice with comment period will not impose spending costs on state, local, or tribal governments in the aggregate, or by the private sector of $148 million or more.

    Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on state and local governments, preempts state law, or otherwise has Federalism implications. As stated previously, this notice with comment period will not have a substantial effect on state and local governments.

    C. Anticipated Effects

    In this section, we discuss the historical background of the IPF PPS and the impact of this notice with comment period on the Federal Medicare budget and on IPFs.

    1. Budgetary Impact

    As discussed in the November 2004 and May 2006 IPF PPS final rules, we applied a budget neutrality factor to the federal per diem base rate and ECT payment per treatment to ensure that total estimated payments under the IPF PPS in the implementation period would equal the amount that would have been paid if the IPF PPS had not been implemented. The budget neutrality factor includes the following components: outlier adjustment, stop-loss adjustment, and the behavioral offset. As discussed in the May 2008 IPF PPS notice (73 FR 25711), the stop-loss adjustment is no longer applicable under the IPF PPS.

    As discussed in section III.D.1 of this notice with comment period, we are using the wage index and labor-related share in a budget neutral manner by applying a wage index budget neutrality factor to the federal per diem base rate and ECT payment per treatment. Therefore, the budgetary impact to the Medicare program of this notice with comment period will be due to the market basket update for FY 2018 of 2.6 percent (see section III.A.2 of this notice with comment period) less the productivity adjustment of 0.6 percentage point required by section 1886(s)(2)(A)(i) of the Act; further reduced by the “other adjustment” of 0.75 percentage point under sections 1886(s)(2)(A)(ii) and 1886 (s)(3)(E) of the Act; and the update to the outlier fixed dollar loss threshold amount.

    We estimate that the FY 2018 impact will be a net increase of $45 million in payments to IPF providers. This reflects an estimated $55 million increase from the update to the payment rates and a $10 million decrease due to the update to the outlier threshold amount to set total estimated outlier payments at 2.0 percent of total estimated payments in FY 2018. This estimate does not include the implementation of the required 2.0 percentage point reduction of the market basket increase factor for any IPF that fails to meet the IPF quality reporting requirements (as discussed in section III.B.2 of this notice with comment period).

    2. Impact on Providers

    To show the impact on providers of the changes to the IPF PPS discussed in this notice with comment period, we compare estimated payments under the IPF PPS rates and factors for FY 2018 versus those under FY 2017. We determined the percent change of estimated FY 2018 IPF PPS payments compared to FY 2017 IPF PPS payments for each category of IPFs. In addition, for each category of IPFs, we have included the estimated percent change in payments resulting from the update to the outlier fixed dollar loss threshold amount; the updated wage index data including the updated labor-related share; and the market basket update for FY 2018, as adjusted by the productivity adjustment according to section 1886(s)(2)(A)(i) of the Act, and the “other adjustment” according to sections 1886(s)(2)(A)(ii) and 1886(s)(3)(E) of the Act.

    To illustrate the impacts of the FY 2018 changes in this notice with comment period, our analysis begins with a FY 2017 baseline simulation model based on FY 2016 IPF payments inflated to the midpoint of FY 2017 using IHS Global Inc.'s most recent forecast of the market basket update (see section III.A.2. of this notice with comment period); the estimated outlier payments in FY 2017; the FY 2016 pre-floor, pre-reclassified hospital wage index; the FY 2017 labor-related share; and the FY 2017 percentage amount of the rural adjustment. During the simulation, total outlier payments are maintained at 2 percent of total estimated IPF PPS payments.

    Each of the following changes is added incrementally to this baseline model in order for us to isolate the effects of each change:

    • The update to the outlier fixed dollar loss threshold amount.

    • The FY 2017 pre-floor, pre-reclassified hospital wage index.

    • The FY 2018 labor-related share.

    • The market basket update for FY 2018 of 2.6 percent less the productivity adjustment of 0.6 percentage point in accordance with section 1886(s)(2)(A)(i) of the Act and further reduced by the “other adjustment” of 0.75 percentage point in accordance with sections 1886(s)(2)(A)(ii) and 1886(s)(3)(E) of the Act, for a payment rate update of 1.25 percent.

    Our final column comparison illustrates the percent change in payments from FY 2017 (that is, October 1, 2016, to September 30, 2017) to FY 2018 (that is, October 1, 2017, to September 30, 2018) including all the changes in this notice with comment period.

    Table 2—IPF PPS Impacts for FY 2018 [Percent change in columns 3 through 6] Facility by type Number of
  • facilities
  • Outlier CBSA wage index and
  • labor share
  • Payment
  • update 1
  • Total percent change 2
    (1) (2) (3) (4) (5) (6) All Facilities 1,621 −0.26 0.00 1.25 0.99 Total Urban 1,277 −0.26 −0.06 1.25 0.93 Total Rural 344 −0.26 0.38 1.25 1.37 Urban unit 827 −0.38 −0.20 1.25 0.67 Urban hospital 450 −0.09 0.13 1.25 1.29 Rural unit 277 −0.31 0.39 1.25 1.33 Rural hospital 67 −0.14 0.34 1.25 1.45 By Type of Ownership: Freestanding IPFs:  Urban Psychiatric Hospitals: Government 121 −0.32 −0.09 1.25 0.83 Non-Profit 97 −0.13 0.49 1.25 1.61 For-Profit 232 −0.03 0.04 1.25 1.26  Rural Psychiatric Hospitals: Government 33 −0.14 0.90 1.25 2.02 Non-Profit 13 −0.12 −0.26 1.25 0.87 For-Profit 21 −0.14 0.11 1.25 1.22 IPF Units:  Urban: Government 118 −0.61 −0.36 1.25 0.27 Non-Profit 535 −0.38 −0.29 1.25 0.57 For-Profit 174 −0.19 0.17 1.25 1.22  Rural: Government 68 −0.31 0.35 1.25 1.29 Non-Profit 147 −0.31 0.50 1.25 1.44 For-Profit 62 −0.30 0.19 1.25 1.14 By Teaching Status: Non-teaching 1,436 −0.22 0.04 1.25 1.06 Less than 10% interns and residents to beds 104 −0.37 −0.12 1.25 0.75 10% to 30% interns and residents to beds 60 −0.54 −0.39 1.25 0.31 More than 30% interns and residents to beds 21 −0.49 0.17 1.25 0.93 By Region: New England 106 −0.31 −0.46 1.25 0.47 Mid-Atlantic 233 −0.34 0.04 1.25 0.94 South Atlantic 240 −0.15 −0.25 1.25 0.85 East North Central 269 −0.23 −0.03 1.25 0.99 East South Central 165 −0.24 −0.08 1.25 0.93 West North Central 133 −0.34 −0.05 1.25 0.85 West South Central 244 −0.20 0.13 1.25 1.18 Mountain 105 −0.16 0.17 1.25 1.25 Pacific 126 −0.37 0.62 1.25 1.50 By Bed Size:  Psychiatric Hospitals Beds: 0-24 86 −0.09 0.27 1.25 1.43 Beds: 25-49 74 −0.12 −0.04 1.25 1.09 Beds: 50-75 88 −0.14 0.24 1.25 1.35 Beds: 76+ 269 −0.08 0.15 1.25 1.32  Psychiatric Units Beds: 0-24 640 −0.40 −0.01 1.25 0.83 Beds: 25-49 288 −0.34 −0.12 1.25 0.78 Beds: 50-75 112 −0.35 −0.30 1.25 0.60 Beds: 76+ 64 −0.32 −0.08 1.25 0.84 1 This column reflects the payment update impact of the IPF market basket update for FY 2018 of 2.6 percent, a 0.6 percentage point reduction for the productivity adjustment as required by section 1886(s)(2)(A)(i) of the Act, and a 0.75 percentage point reduction in accordance with sections 1886(s)(2)(A)(ii) and 1886(s)(3)(E) of the Act. 2 Percent changes in estimated payments from FY 2017 to FY 2018 include all of the changes presented in this notice. Note, the products of these impacts may be different from the percentage changes shown here due to rounding effects.
    3. Results

    Table 2 displays the results of our analysis. The table groups IPFs into the categories listed below based on characteristics provided in the Provider of Services (POS) file, the IPF provider specific file, and cost report data from the Healthcare Cost Report Information System:

    • Facility Type • Location • Teaching Status Adjustment • Census Region • Size

    The top row of the table shows the overall impact on the 1,621 IPFs included in this analysis. In column 3, we present the effects of the update to the outlier fixed dollar loss threshold amount. We estimate that IPF outlier payments as a percentage of total IPF payments are 2.26 percent in FY 2017. Thus, we are adjusting the outlier threshold amount in this notice with comment period to set total estimated outlier payments equal to 2 percent of total payments in FY 2018. The estimated change in total IPF payments for FY 2018, therefore, includes an approximate 0.26 percent decrease in payments because the outlier portion of total payments is expected to decrease from approximately 2.26 percent to 2.0 percent.

    The overall impact of this outlier adjustment update (as shown in column 3 of Table 2), across all hospital groups, is to decrease total estimated payments to IPFs by 0.26 percent. The largest decrease in payments is estimated to be a 0.61 percent decrease in payments for urban government IPF units.

    In column 4, we present the effects of the budget-neutral update to the IPF wage index and the Labor-Related Share (LRS). This represents the effect of using the most recent wage data available and taking into account the updated OMB delineations. That is, the impact represented in this column reflects the update from the FY 2017 IPF wage index to the FY 2018 IPF wage index, which includes the LRS update from 75.1 percent in FY 2017 to 75.0 percent in FY 2018. We note that there is no projected change in aggregate payments to IPFs, as indicated in the first row of column 4, however, there will be distributional effects among different categories of IPFs. For example, we estimate the largest increase in payments to be 0.90 percent for rural government psychiatric hospitals, and the largest decrease in payments to be 0.46 percent for New England IPFs.

    In column 5, we present the estimated effects of the update to the IPF PPS payment rates of 1.25 percent, which are based on the 2012-based IPF market basket update of 2.6 percent, less the productivity adjustment of 0.6 percentage point in accordance with section 1886(s)(2)(A)(i) of the Act, and further reduced by 0.75 percentage point in accordance with sections 1886(s)(2)(A)(ii) and 1886(s)(3)(E) of the Act.

    Finally, column 6 compares our estimates of the total changes reflected in this notice with comment period for FY 2018 to the estimates for FY 2017 (without these changes). The average estimated increase for all IPFs is approximately 0.99 percent. This estimated net increase includes the effects of the 2.6 percent market basket update reduced by the productivity adjustment of 0.6 percentage point, as required by section 1886(s)(2)(A)(i) of the Act and further reduced by the “other adjustment” of 0.75 percentage point, as required by sections 1886(s)(2)(A)(ii) and 1886(s)(3)(E) of the Act. It also includes the overall estimated 0.26 percent decrease in estimated IPF outlier payments as a percent of total payments from the update to the outlier fixed dollar loss threshold amount.

    IPF payments are estimated to increase by 0.93 percent in urban areas and 1.37 percent in rural areas. Overall, IPFs are estimated to experience a net increase in payments as a result of the updates in this notice with comment period. The largest payment increase is estimated at 2.02 percent for rural government psychiatric hospitals.

    4. Effect on Beneficiaries

    Under the IPF PPS, IPFs will receive payment based on the average resources consumed by patients for each day. We do not expect changes in the quality of care or access to services for Medicare beneficiaries under the FY 2018 IPF PPS, but we continue to expect that paying prospectively for IPF services will enhance the efficiency of the Medicare program.

    5. Regulatory Review Costs

    If regulations impose administrative costs on private entities, such as the time needed to read and interpret this notice with comment period, we should estimate the cost associated with regulatory review. Due to the uncertainty involved with accurately quantifying the number of entities that will review the notice with comment period, we assume that the total number of unique commenters on the most recent IPF proposed rule from FY 2016 will be the number of reviewers of this notice with comment period. We acknowledge that this assumption may understate or overstate the costs of reviewing this notice with comment period. It is possible that not all commenters reviewed the FY 2016 IPF proposed rule in detail, and it is also possible that some reviewers chose not to comment on that proposed rule. For these reasons we thought that the number of past commenters would be a fair estimate of the number of reviewers of this notice with comment period. We welcome any comments on the approach in estimating the number of entities which will review this notice with comment period.

    We also recognize that different types of entities are in many cases affected by mutually exclusive sections of this notice with comment period, and therefore for the purposes of our estimate we assume that each reviewer reads approximately 50 percent of the notice with comment period. We seek comments on this assumption.

    Using the wage information from the BLS for medical and health service managers (Code 11-9111), we estimate that the cost of reviewing this notice with comment period is $105.16 per hour, including overhead and fringe benefits (https://www.bls.gov/oes/current/oes_nat.htm). Assuming an average reading speed, we estimate that it would take approximately 0.62 hours for the staff to review half of this notice with comment period. For each IPF that reviews the notice with comment period, the estimated cost is $65.20 (0.62 hours × $105.16). Therefore, we estimate that the total cost of reviewing this notice with comment period is $4,955.20 ($65.20 × 76 reviewers).

    6. Reducing Regulation and Controlling Regulatory Costs

    Executive Order 13771, titled “Reducing Regulation and Controlling Regulatory Costs,” was issued on January 30, 2017 (82 FR 9339, February 3, 2017). It has been determined that this notice with comment period is a transfer notice that does not impose more than de minimis costs and thus is not a regulatory action for the purposes of E.O. 13771.

    D. Alternatives Considered

    The statute does not specify an update strategy for the IPF PPS and is broadly written to give the Secretary discretion in establishing an update methodology. Therefore, we are updating the IPF PPS using the methodology published in the November 2004 IPF PPS final rule; applying the FY 2018 2012-based IPF PPS market basket update of 2.6 percent, reduced by the statutorily required multifactor productivity adjustment of 0.6 percentage point and the other adjustment of 0.75 percentage point, along with the wage index budget neutrality adjustment to update the payment rates; finalizing a FY 2018 IPF PPS wage index which is fully based upon the OMB CBSA designations found in OMB Bulletin 15-01; and continuing with the third and final year of the 3-year phase-out of the rural adjustment for IPF providers which changed from rural to urban status in FY 2016 as a result of adopting the updated OMB CBSA delineations from OMB Bulletin 13-01, which were used in the FY 2016 IPF PPS transitional wage index.

    E. Accounting Statement

    As required by OMB Circular A-4 (available at www.whitehouse.gov/sites/whitehouse.gov/files/omb/circulars/A4/a-4.pdf), in Table 3, we have prepared an accounting statement showing the classification of the expenditures associated with the updates to the IPF PPS wage index and payment rates in this notice with comment period. This table provides our best estimate of the increase in Medicare payments under the IPF PPS as a result of the changes presented in this notice with comment period and based on the data for 1,621 IPFs in our database.

    Table 3—Accounting Statement: Classification of Estimated Expenditures Category Transfers Change in Estimated Transfers from FY 2017 IPF PPS to FY 2018 IPF PPS Annualized Monetized Transfers $45 million. From Whom to Whom? Federal Government to IPF Medicare Providers.

    In accordance with the provisions of Executive Order 12866, this notice with comment period was reviewed by the Office of Management and Budget.

    Dated: July 21, 2017. Seema Verma, Administrator, Centers for Medicare & Medicaid Services. Dated: July 24, 2017. Thomas E. Price, Secretary, Department of Health and Human Services.
    [FR Doc. 2017-16430 Filed 8-2-17; 4:15 pm] BILLING CODE 4120-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-1063] Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice; establishment of a public docket; request for comments.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Oncologic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

    DATES:

    The public meeting will be held on September 19, 2017, from 8:30 a.m. to 1 p.m.

    ADDRESSES:

    FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-0002. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.

    FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2017-N-1063. The docket will close on September 18, 2017. Submit either electronic or written comments on this public meeting by September 18, 2017.

    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 September 18, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of September 18, 2017. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

    Comments received on or before September 5, 2017, will be provided to the committee. Comments received after that date will be taken into consideration by the Agency.

    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-1063 for “Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; 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:

    Cindy Chee, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001, FAX: 301-847-8533, email: [email protected], or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency's Web site at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting.

    SUPPLEMENTARY INFORMATION:

    Agenda: The committee will discuss supplemental new drug application (sNDA) 021938/033 SUTENT (sunitinib malate) oral capsules, submitted by C.P. Pharmaceuticals International C.V., represented by Pfizer, Inc. (authorized U.S. agent). The proposed indication (use) for this product is for the adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma following nephrectomy.

    FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting link.

    Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. All electronic and written submissions submitted to the docket (see ADDRESSES) on or before September 5, 2017, will be provided to the committee. Oral presentations from the public will be scheduled between approximately 11 a.m. and noon. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before August 25, 2017. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by August 28, 2017.

    Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets.

    FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require special accommodations due to a disability, please contact Cindy Chee at least 7 days in advance of the meeting.

    FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct during advisory committee meetings.

    Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).

    Dated: August 1, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
    [FR Doc. 2017-16518 Filed 8-4-17; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-E-2531] Determination of Regulatory Review Period for Purposes of Patent Extension; CINQAIR AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for CINQAIR and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.

    DATES:

    Anyone with knowledge that any of the dates as published (in the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by October 6, 2017. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by February 5, 2018. See “Petitions” in the SUPPLEMENTARY INFORMATION section for more information.

    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 October 6, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of October 6, 2017. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

    Electronic Submissions

    Submit electronic comments in the following way:

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

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

    Written/Paper Submissions

    Submit written/paper submissions as follows:

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

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

    Instructions: All submissions received must include the Docket No. FDA-2016-E-2531 for “Determination of Regulatory Review Period for Purposes of Patent Extension; CINQAIR.” 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:

    Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.

    SUPPLEMENTARY INFORMATION:

    I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.

    A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human biological products, the testing phase begins when the exemption to permit the clinical investigations of the biological product becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human biological product and continues until FDA grants permission to market the biological product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human biological product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).

    FDA has approved for marketing the human biologic product CINQAIR (reslizumab). CINQAIR is indicated for add-on maintenance treatment of patients with severe asthma aged 18 years and older, and with an eosinophilic phenotype. Subsequent to this approval, the USPTO received a patent term restoration application for CINQAIR (U.S. Patent No. RE39,548) from UCB Celltech, and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated September 26, 2016, FDA advised the USPTO that this human biological product had undergone a regulatory review period and that the approval of CINQAIR represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.

    II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for CINQAIR is 5,685 days. Of this time, 5,325 days occurred during the testing phase of the regulatory review period, while 360 days occurred during the approval phase. These periods of time were derived from the following dates:

    1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: August 31, 2000. The applicant claims February 15, 2008, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was August 31, 2000, which was 30 days after FDA receipt of the first IND.

    2. The date the application was initially submitted with respect to the human biological product under section 351 of the Public Health Service Act (42 U.S.C. 262): March 30, 2015. FDA has verified the applicant's claim that the biologics license application (BLA) for CINQAIR (BLA 761033) was initially submitted on March 30, 2015.

    3. The date the application was approved: March 23, 2016. FDA has verified the applicant's claim that BLA 761033 was approved on March 23, 2016.

    This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,660 days of patent term extension.

    III. Petitions

    Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as specified in 21 CFR 60.30, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must be timely (see DATES) and contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30.

    Submit petitions electronically to http://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: August 1, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
    [FR Doc. 2017-16516 Filed 8-4-17; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-0041] Agency Information Collection Activities; Proposed Collection; Comment Request; Safety Assurance Case; Withdrawal of Notice AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice; withdrawal.

    SUMMARY:

    The Food and Drug Administration (FDA) is announcing the withdrawal of a notice that was published in the Federal Register of March 15, 2017.

    DATES:

    August 7, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, [email protected]

    SUPPLEMENTARY INFORMATION:

    In a notice published in the Federal Register of March 15, 2017 (82 FR 13817), “Agency Information Collection Activities; Proposed Collection; Comment Request; Safety Assurance Case,” FDA requested comment on the information collection associated with safety assurance cases (SACs).

    Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice.

    In the March 15, 2017, Federal Register notice, FDA proposed to extend the information collection related to SACs (OMB control number 0910-0766). However, we are withdrawing the notice because, upon further review of the information collection request (ICR) associated with the notice and comments received on the information collection, we have determined that the estimated burden expressed in the SAC ICR is included as part of the estimated burden for the information collections in the premarket notification (510(k)) ICR (OMB control number 0910-0120).

    Because the information collected for safety assurance cases is already included under another information collection approval, we have discontinued the ICR and we are withdrawing the March 15, 2017, notice requesting comment on the information collection.

    The guidance entitled “Infusion Pumps Total Product Life Cycle; Guidance for Industry and FDA Staff” (https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm209337.pdf), which provides recommendations on the inclusion of safety assurance cases as part of the premarket submissions for new, changed, or modified infusion pumps submitted by device manufacturers, continues to provide the Agency's current thinking on this topic.

    Dated: August 2, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
    [FR Doc. 2017-16561 Filed 8-4-17; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0369] Product-Specific Guidances; Final Guidances 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 final product-specific guidances. The guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled “Bioequivalence Recommendations for Specific Products” that explained the process that would be used to make product-specific BE recommendations available to the public on FDA's Web site. The product-specific guidances identified in this notice were developed using the process described in that guidance.

    DATES:

    Submit either electronic or written comments on Agency guidances at any time.

    ADDRESSES:

    You may submit comments as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

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

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

    Written/Paper Submissions

    Submit written/paper submissions as follows:

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

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

    Instructions: All submissions received must include the Docket No. FDA-2007-D-0369 for “Product-Specific Guidances; Final Guidances 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.

    Submit written requests for single copies of a final 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 a final guidance document.

    FOR FURTHER INFORMATION CONTACT:

    Xiaoqiu Tang, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4730, Silver Spring, MD 20993-0002, 301-796-5850.

    SUPPLEMENTARY INFORMATION:

    I. Background

    In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the availability of a guidance for industry entitled “Bioequivalence Recommendations for Specific Products” that explained the process that would be used to make product-specific guidances available to the public on FDA's Web site at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.

    As described in that guidance, FDA adopted this process as a means to develop and disseminate product-specific guidances and provide a meaningful opportunity for the public to consider and comment on those guidances. Under that process, draft guidances are posted on FDA's Web site and announced periodically in the Federal Register. The public is encouraged to submit comments on those recommendations within 60 days of their announcement in the Federal Register. FDA considers any comments received and either publishes final guidances or publishes revised draft guidances for comment. Final product-specific guidances were last announced in the Federal Register on September 21, 2015 (80 FR 57000). This notice announces final product-specific guidances that are posted on FDA's Web site.

    II. Drug Products For Which Final Product-Specific Guidances Are Available

    FDA is announcing the availability of final product-specific guidances for industry for drug products containing the following active ingredients:

    Table 1—Final Product-Specific Guidances for Drug Products Acarbose. Acetaminophen; Aspirin, Caffeine. Acetaminophen; Butalbital; Caffeine; Codeine phosphate. Acitretin. Amoxicillin (multiple reference listed drugs). Amoxicillin; Clavulanate potassium. Aspirin; Butalbital; Caffeine (multiple reference listed drugs). Aspirin; Butalbital; Caffeine; Codeine Phosphate. Atenolol. Atenolol and Chlorthalidone. Cetirizine HCl. Chlorthalidone. Citalopram HBr. Citalopram hydrobromide. Clarithromycin. Clindamycin HCl. Clomiphene Citrate. Clonazepam. Clozapine. Cyclobenzaprine HCL. Cycloserine. Dapsone. Desipramine HCl. Desmopressin Acetate. Diflunisal. Diphenhydramine HCl. Dipyridamole. Disulfiram. Donepezil HCl. Doxazosin mesylate. Doxepin HCl. Doxercalciferol. Eprosartan Mesylate. Ethambutol HCl. Hydrochlorothiazide; Losartan Potassium. Hydrochlorothiazide; Triamterene. Hydrochlorothiazide; Valsartan. Hydrocodone bitartrate; Ibuprofen. Hydrocortisone. Hydromorphone HCl. Selegiline hydrochloride. Sotalol HCl. Tenofovir Disoproxil Fumarate. Tiagabine HCl. Valproic acid. Verapamil HCl.

    For a complete history of previously published Federal Register notices related to product-specific guidances, go to https://www.regulations.gov and enter Docket No. FDA-2007-D-0369.

    These final guidances are being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). These guidances represent the current thinking of FDA on, among other things, the product-specific design of BE studies to support ANDAs. They do not establish any rights for any person and are not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

    III. Electronic Access

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

    Dated: August 2, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
    [FR Doc. 2017-16581 Filed 8-4-17; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2016-E-2171, FDA-2016-E-2169, and FDA-2016-E-2170] Determination of Regulatory Review Period for Purposes of Patent Extension; VONVENDI AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for VONVENDI and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.

    DATES:

    Anyone with knowledge that any of the dates as published (in the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by October 6, 2017. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by February 5, 2018. See “Petitions” in the SUPPLEMENTARY INFORMATION section for more information.

    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 October 6, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of October 6, 2017. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

    Electronic Submissions

    Submit electronic comments in the following way:

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

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

    Written/Paper Submissions

    Submit written/paper submissions as follows:

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

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

    Instructions: All submissions received must include the Docket Nos. FDA-2016-E-2171, FDA-2016-E-2169, and FDA-2016-E-2170 for “Determination of Regulatory Review Period for Purposes of Patent Extension; VONVENDI.” 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:

    Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.

    SUPPLEMENTARY INFORMATION:

    I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.

    A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human biological products, the testing phase begins when the exemption to permit the clinical investigations of the biological product becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human biological product and continues until FDA grants permission to market the biological product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human biological product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).

    FDA has approved for marketing the human biologic product VONVENDI (von Willebrand Factor (Recombinant)). VONVENDI is indicated for on-demand treatment and control of bleeding episodes in adults diagnosed with von Willebrand disease. Subsequent to this approval, the USPTO received patent term restoration applications for VONVENDI (U.S. Patent Nos. 6,465,624; 6,531,577; and 6,579,723) from Baxalta GmbH and Baxalta Inc., and the USPTO requested FDA's assistance in determining the patents' eligibility for patent term restoration. In a letter dated September 1, 2016, FDA advised the USPTO that this human biological product had undergone a regulatory review period and that the approval of VONVENDI represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.

    II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for VONVENDI is 2,690 days. Of this time, 2,335 days occurred during the testing phase of the regulatory review period, while 355 days occurred during the approval phase. These periods of time were derived from the following dates:

    1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: July 29, 2008. The applicants claim July 30, 2008, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was July 29, 2008, which was 30 days after FDA receipt of the IND.

    2. The date the application was initially submitted with respect to the human biological product under section 351 of the Public Health Service Act (42 U.S.C. 262): December 19, 2014. FDA has verified the applicant's claim that the biologics license application (BLA) for VONVENDI (BLA 125577) was initially submitted on December 19, 2014.

    3. The date the application was approved: December 8, 2015. FDA has verified the applicant's claim that BLA 125577 was approved on December 8, 2015.

    This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In the applications for patent extension, these applicants seek 1,521 days of patent term extension.

    III. Petitions

    Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as specified in 21 CFR 60.30, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must be timely (see DATES) and contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30.

    Submit petitions electronically to https://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: August 1, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
    [FR Doc. 2017-16515 Filed 8-4-17; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-N-0222] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry—User Fee Waivers, Reductions, and Refunds for Drug and Biological Products AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA, Agency or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

    DATES:

    Fax written comments on the collection of information by September 6, 2017.

    ADDRESSES:

    To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to [email protected]. All comments should be identified with the OMB control number 0910-0693. Also include the FDA docket number found in brackets in the heading of this document.

    FOR FURTHER INFORMATION CONTACT:

    Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, [email protected].

    SUPPLEMENTARY INFORMATION:

    In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

    Guidance for Industry—User Fee Waivers, Reductions, and Refunds for Drug and Biological Products OMB Control Number 0910-0693—Extension

    The guidance provides recommendations for applicants planning to request waivers or reductions in prescription drug user fees assessed under sections 735 and 736 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g and 21 U.S.C. 379h) (the FD&C Act). The guidance describes the types of waivers and reductions permitted under the prescription drug user fee provisions of the FD&C Act, and the procedures for submitting requests for waivers or reductions. It also includes recommendations for submitting information for requests for reconsideration of denials of waiver or reduction requests, and for requests for appeals. The guidance also provides clarification on related issues such as user fee exemptions for orphan drugs.

    Based on Agency records, we estimate that the total annual number of waiver requests submitted for all of these categories will be 150, submitted by 115 different applicants. We estimate that the average burden hours for preparation of a submission will total 16 hours. Because FDA may request additional information from the applicant during the review period, we have also included in this estimate time to prepare any additional information. We have included in the burden estimate the preparation and submission of application fee waivers for small businesses, because small businesses requesting a waiver must submit documentation to FDA on the number of their employees and must include the information that the application is the first human drug application, within the meaning of the FD&C Act, to be submitted to the Agency for approval.

    Previously, after receipt of a small business waiver request, FDA would request a small business size determination from the Small Business Administration (SBA). Waiver applicants would submit their supporting documentation directly to SBA for evaluation and after completing their review, SBA provided FDA with a determination whether a waiver applicant qualified as a small business for purposes of evaluating user fee waivers. The burden for submission of this information to SBA is approved under OMB control number 3245-0101.

    Beginning fiscal year 2015, the SBA declined to conduct further size determinations for evaluation of small business user fee waivers and as a result, a processing change at FDA occurred. The new FDA process requires waiver applicants to submit documentation directly to FDA. In addition, fewer supporting documents than previously requested by SBA are required. As a result, we estimate that the 4 burden hours per small business waiver previously attributed to SBA and approved under OMB control number 3245-0101, should now be attributed to FDA because SBA is no longer conducting size determinations for FDA. Also, because FDA is asking that applicants submit fewer supporting documents, we estimate that these burden hours should be reduced to 2 hours instead of 4 hours. We understand that SBA plans to submit a revised burden estimate to OMB control number 3245-0101 to account for this redistribution.

    The reconsideration and appeal requests are not addressed in the FD&C Act, but are discussed in the guidance. We estimate that we will receive seven requests for reconsideration annually, and that the total average burden hours for a reconsideration request will be 24 hours. In addition, we estimate that we will receive one request annually for an appeal of a user fee waiver determination, and that the time needed to prepare an appeal would be approximately 12 hours. We have included in this estimate both the time needed to prepare the request for appeal to the Chief Scientist, User Fee Appeals Officer, Office of the Commissioner, and the time needed to create and send a copy of the request for an appeal to the Director, Division of User Fee Management, Office of Management, Center for Drug Evaluation and Research.

    The burden for completing and submitting Form FDA 3397 (Prescription Drug User Fee Coversheet) is not included in this analysis as the burden is included under OMB control number 0910-0297. The collections of information associated with submission of a new drug application or biologics license application are approved under OMB control numbers 0910-0001 and 0910-0338, respectively.

    In the Federal Register of May 23, 2017 (82 FR 23581), FDA published a 60-day notice requesting public comment on the proposed extension of this collection of information. No comments were received.

    FDA estimates the burden of this collection of information as follows:

    Table 1—Estimated Annual Reporting Burden 1 User fee waivers, reductions, & refunds for
  • drug & biological products
  • Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Total annual responses Average
  • burden per
  • response
  • Total hours
    FD&C Act sections 735 and 736 115 1.3 150 16 2,400 FD&C Act section 736(d)(1)(D)(4) 25 1 25 2 50 Reconsideration requests 7 1 7 24 168 Appeal requests 1 1 1 12 12 Total 2,630 1 There are no capital costs or operating and maintenance costs associated with this collection of information.
    Dated: August 2, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
    [FR Doc. 2017-16580 Filed 8-4-17; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-0001] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA or the Agency) announces a forthcoming public advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC). The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.

    DATES:

    The meeting will be held on September 13, 2017, from 8:30 a.m. to 5 p.m.

    ADDRESSES:

    FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-0002. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.

    FOR FURTHER INFORMATION CONTACT:

    Serina Hunter-Thomas or Rosanna Harvey, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6307C, Silver Spring, MD 20993-0002; 240-402-5771, [email protected] and 240-402-8072, [email protected]; or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency's Web site at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting.

    SUPPLEMENTARY INFORMATION:

    Agenda: On September 13, 2017, the VRBPAC will meet in an open session to discuss and make recommendations on the safety and effectiveness of Zoster Vaccine Recombinant, Adjuvanted, manufactured by GlaxoSmithKline Biologicals. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting link.

    Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before September 6, 2017. Oral presentations from the public will be scheduled between approximately 1:30 p.m. and 2:30 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before August 29, 2017. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by August 30, 2017.

    Web cast: For those unable to attend in person, the meeting will also be web cast and will be available at the following link: https://collaboration.fda.gov/vrbpac0917/.

    Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets.

    FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Serina Hunter-Thomas at least 7 days in advance of the meeting.

    FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct during advisory committee meetings.

    Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).

    Dated: August 1, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
    [FR Doc. 2017-16519 Filed 8-4-17; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0085] Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the proposed extension of the collection of information concerning cooperative manufacturing arrangements for licensed biologics.

    DATES:

    Submit either electronic or written comments on the collection of information by October 6, 2017.

    ADDRESSES:

    You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before October 6, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of October 6, 2017. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

    Electronic Submissions

    Submit electronic comments in the following way:

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

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

    Written/Paper Submissions

    Submit written/paper submissions as follows:

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

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

    Instructions: All submissions received must include the Docket No. FDA-2011-N-0085 for “Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics.” Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

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

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

    FOR FURTHER INFORMATION CONTACT:

    Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3850, [email protected]

    SUPPLEMENTARY INFORMATION:

    Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

    With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

    Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics OMB Control Number 0910-0629—Extension

    This information collection supports the Agency guidance document entitled, “Guidance for Industry: Cooperative Manufacturing for Licensed Biologics.” The guidance document provides information concerning cooperative manufacturing arrangements applicable to biological products subject to licensure under section 351 of the Public Health Service Act (42 U.S.C. 262). The guidance addresses several types of manufacturing arrangements (i.e., short supply arrangements, divided manufacturing arrangements, shared manufacturing arrangements, and contract manufacturing arrangements) and describes certain reporting and recordkeeping responsibilities associated with these arrangements, including the following: (1) Notification of all important proposed changes to production and facilities; (2) notification of results of tests and investigations regarding or possibly impacting the product; (3) notification of products manufactured in a contract facility; and (4) standard operating procedures.

    1. Notification of All Important Proposed Changes to Production and Facilities

    Each licensed manufacturer in a divided manufacturing arrangement or shared manufacturing arrangement must notify the appropriate FDA Center regarding proposed changes in the manufacture, testing, or specifications of its product, in accordance with § 601.12 (21 CFR 601.12). In the guidance, we recommend that each licensed manufacturer that proposes such a change should also inform other participating licensed manufacturer(s) of the proposed change.

    For contract manufacturing arrangements, we recommend that the contract manufacturer should share with the license manufacturer all important proposed changes to production and facilities (including introduction of new products or at inspection). The license holder is responsible for reporting these changes to FDA (21 CFR 601.12).

    2. Notification of Results of Tests and Investigations Regarding or Possibly Impacting the Product

    In the guidance, we recommend the following for contract manufacturing arrangements:

    • The contract manufacturer should fully inform the license manufacturer of the results of all tests and investigations regarding or possibly having an impact on the product; and

    • The license manufacturer should obtain assurance from the contractor that any FDA list of inspectional observations will be shared with the license manufacturer to allow evaluation of its impact on the purity, potency, and safety of the license manufacturer's product.

    3. Notification of Products Manufactured in a Contract Facility

    In the guidance, we recommend for contract manufacturing arrangements that a license manufacturer cross reference a contract manufacturing facility's master files only in circumstances involving certain proprietary information of the contract manufacturer, such as a list of all products manufactured in a contract facility. In this situation, the license manufacturer should be kept informed of the types or categories of all products manufactured in the contract facility.

    4. Standard Operating Procedures

    In the guidance, we remind the license manufacturer that the license manufacturer assumes responsibility for compliance with the applicable product and establishment standards (21 CFR 600.3(t)). Therefore, if the license manufacturer enters into an agreement with a contract manufacturing facility, the license manufacturer must ensure that the facility complies with the applicable standards. An agreement between a license manufacturer and a contract manufacturing facility normally includes procedures to regularly assess the contract manufacturing facility's compliance. These procedures may include, but are not limited to, review of records and manufacturing deviations and defects, and periodic audits.

    For shared manufacturing arrangements, each manufacturer must submit a separate biologics license application describing the manufacturing facilities and operations applicable to the preparation of that manufacturer's biological substance or product (§ 601.2(a)). In the guidance, we state that we expect the manufacturer that prepares, or is responsible for the preparation of, the product in final form for commercial distribution to assume primary responsibility for providing data demonstrating the safety, purity, and potency of the final product. We also state that we expect the licensed finished product manufacturer to be primarily responsible for any postapproval obligations, such as postmarketing clinical trials, additional product stability studies, complaint handling, recalls, postmarket reporting of the dissemination of advertising and promotional labeling materials as required under § 601.12(f)(4), and adverse experience reporting. We recommend that the final product manufacturer establish a procedure with the other participating manufacturer(s) to obtain information in these areas.

    Description of Respondents: Respondents to the information collection are participating licensed manufacturers, final product manufacturers, and contract manufacturers associated with cooperative manufacturing arrangements subject to the associated regulations discussed in the guidance.

    Burden Estimate: We believe that the information collection provisions in the guidance do not create a new burden for respondents. We believe the reporting and recordkeeping provisions are part of usual and customary business practices. Licensed manufacturers would have contractual agreements with participating licensed manufacturers, final product manufacturers, and contract manufacturers, as applicable for the type of cooperative manufacturing arrangement, to address all these information collection provisions.

    The guidance also refers to previously approved collections of information found in FDA regulations at parts 201, 207, 211, 600, 601, 606, 607, 610, 660, 801, 803, 807, 809, and 820 (21 CFR parts 201, 207, 211, 600, 601, 606, 607, 610, 660, 801, 803, 807, 809, and 820). The collections of information in parts 606 and 610 have been approved under OMB control numbers 0910-0116, 0910-0458, and 0910-0206; part 600 has been approved under OMB control numbers 0910-0308 and 0910-0458; parts 601 and 660 have been approved under OMB control number 0910-0338; part 803 has been approved under OMB control number 0910-0437; part 211 has been approved under OMB control number 0910-0139; part 820 has been approved under OMB control number 0910-0073; parts 207, 607, and 807 have been approved under OMB control numbers 0910-0045, 0910-0052, and 0910-0625; and parts 201, 801, and 809 have been approved under OMB control numbers 0910-0537, 0910-0572, and 0910-0485.

    Dated: August 2, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
    [FR Doc. 2017-16564 Filed 8-4-17; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0110] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prescription Drug Advertisements AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

    DATES:

    Fax written comments on the collection of information by September 6, 2017.

    ADDRESSES:

    To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to [email protected] All comments should be identified with the OMB control number 0910-0686. Also include the FDA docket number found in brackets in the heading of this document.

    FOR FURTHER INFORMATION CONTACT:

    Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, [email protected]

    SUPPLEMENTARY INFORMATION:

    In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

    Prescription Drug Advertisements (OMB Control Number 0910-0686—Extension)

    This information collection supports Agency regulations. Section 502(n) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 352(n)) requires that manufacturers, packers, and distributors (sponsors) who advertise prescription human and animal drugs, including biological products for humans, disclose in advertisements certain information about the advertised product's uses and risks. For prescription drugs and biologics, section 502(n) of the FD&C Act requires advertisements to contain “a true statement . . .” of certain information including “. . . information in brief summary relating to side effects, contraindications, and effectiveness . . .” as required by regulations issued by FDA.

    FDA's prescription drug advertising regulations at § 202.1 (21 CFR 202.1) describe requirements and standards for print and broadcast advertisements. Section 202.1 applies to advertisements published in journals, magazines, other periodicals, and newspapers, and advertisements broadcast through media such as radio, television, and telephone communication systems. Print advertisements must include a brief summary of each of the risk concepts from the product's approved package labeling (§ 202.1(e)(1)). Advertisements that are broadcast through media such as television, radio, or telephone communications systems must disclose the major risks from the product's package labeling in either the audio or audio and visual parts of the presentation (§ 202.1(e)(1)); this disclosure is known as the “major statement.” If a broadcast advertisement omits the major statement, or if the major statement minimizes the risks associated with the use of the drug, the advertisement could render the drug misbranded in violation of section 502(n) of the FD&C Act, section 201(n) of the FD&C Act (21 U.S.C. 321(n)), and FDA's implementing regulations at § 202.1(e).

    Advertisements subject to the requirements at § 202.1 are subject to the PRA because these advertisements disclose information to the public. In addition, § 202.1(e)(6) and (j) include provisions that are subject to OMB approval under the PRA.

    Reporting to FDA

    Section 202.1(e)(6) permits a person who would be adversely affected by the enforcement of a provision of § 202.1(e)(6) to request a waiver from FDA for that provision. The waiver request must set forth clearly and concisely the petitioner's interest in the advertisement, the specific provision of § 202.1(e)(6) from which a waiver is sought, a complete copy of the advertisement, and a showing that the advertisement is not false, lacking in fair balance, misleading, or otherwise violative of section 502(n) of the FD&C Act.

    Section 202.1(j), which sets forth requirements for the dissemination of advertisements subject to the standards in § 202.1(e), contains the following information collection that is subject to the PRA:

    Under § 202.1(j)(1), a sponsor must submit advertisements to FDA for prior approval before dissemination if: (1) The sponsor or FDA has received information that has not been widely publicized in medical literature that the use of the drug may cause fatalities or serious damage; (2) FDA has notified the sponsor that the information must be part of the advertisements for the drug; and (3) the sponsor has failed to present to FDA a program for assuring that such information will be publicized promptly and adequately to the medical profession in subsequent advertisements, or if such a program has been presented to FDA but is not being followed by the sponsor.

    Under § 202.1(j)(1)(iii), a sponsor must provide to FDA a program for assuring that significant new adverse information about the drug that becomes known (i.e., use of drug may cause fatalities or serious damage) will be publicized promptly and adequately to the medical profession in any subsequent advertisements.

    Under § 202.1(j)(4), a sponsor may voluntarily submit advertisements to FDA for comment prior to publication.

    Disclosures to the Public

    Under § 202.1, advertisements for human and animal prescription drug and biological products must comply with the standards described in that section.

    Under § 202.1(j)(1), if information that the use of a prescription drug may cause fatalities or serious damage has not been widely publicized in the medical literature, a sponsor must include such information in the advertisements for that drug.

    In the Federal Register of May 23, 2017 (82 FR 23574), we published a 60-day notice requesting public comment on the proposed extension of this collection of information. One comment was received but did not respond to the information collection topics solicited in the notice and therefore we do not discuss it here.

    FDA estimates the burden of this collection of information as follows:

    Table 1—Estimated Annual Reporting Burden 1 21 CFR section or activity Number of
  • respondents
  • Number of
  • responses
  • per
  • respondent
  • Total annual
  • responses
  • Hours per
  • response
  • Total
  • hours
  • CDER 202.1(e)(6); waiver request 1 1 1 12 12 202.1(j)(1); submission of advertisement 1 1 1 2 2 202.1(j)(1)(iii); assuring that adverse information be publicized 1 1 1 12 12 202.1(j)(4); voluntary submission of ad to FDA 71 6.97 495 20 9,900 CBER 202.1(e)(6); waiver request 0 0 0 12 0 202.1(j)(1); submission of advertisement 0 0 0 2 0 202.1(j)(1)(iii); assuring that adverse information be publicized 0 0 0 12 0 202.1(j)(4); voluntary submission of ad to FDA 9 8 72 20 1,440 CVM 202.1(e)(6); waiver request 0 0 0 12 0 202.1(j)(1); submission of advertisement 0 0 0 2 0 202.1(j)(1)(iii); assuring that adverse information be publicized 0 0 0 12 0 202.1(j)(4); voluntary submission of ad to FDA 5 1 5 20 100 Total 11,466 1 There are no capital costs or operating and maintenance costs associated with this collection.
    Table 2—Estimated Annual Third-Party Disclosure Burden 1 21 CFR section or activity Number of
  • respondents
  • Number of
  • disclosures
  • per
  • respondent
  • Total annual
  • disclosures
  • Average
  • burden per
  • disclosure
  • Total
  • hours
  • CDER 202.1; ad prepared in accordance with part 202 394 105.3 41,494 400 16,597,600 202.1(j)(1); info. included re. fatalities or serious damage 1 1 1 40 40 CBER 202.1; ad prepared in accordance with part 202 47 63.4 2,984 400 1,193,600 202.1(j)(1); info. included re. fatalities or serious damage 0 0 0 40 0 CVM 202.1; ad prepared in accordance with part 202 25 36 900 400 360,000 202.1(j)(1); info. included re. fatalities or serious damage 0 0 0 40 0 Total 18,151,240 1 There are no capital costs or operating and maintenance costs associated with this collection.
    Dated: August 2, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
    [FR Doc. 2017-16607 Filed 8-4-17; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Information Collection Request Title: AIDS Drug Assistance Program Data Report, OMB No. 0915-0345—Extension AGENCY:

    Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS).

    ACTION:

    Notice

    SUMMARY:

    In compliance with the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.

    DATES:

    Comments on this ICR should be received no later than September 6, 2017.

    ADDRESSES:

    Submit your comments, including the ICR Title, to the desk officer for HRSA, either by email to [email protected] or by fax to 202-395-5806.

    FOR FURTHER INFORMATION CONTACT:

    To request a copy of the clearance requests submitted to OMB for review, email the HRSA Information Collection Clearance Officer at [email protected] or call (301) 443-1984.

    SUPPLEMENTARY INFORMATION:

    When submitting comments or requesting information, please include the information request collection title for reference, in compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995.

    Information Collection Request Title: AIDS Drug Assistance Program Data Report OMB No. 0915-0345—Extension.

    Abstract: HRSA's AIDS Drug Assistance Program (ADAP) is funded through the Ryan White HIV/AIDS Program (RWHAP), Part B, Title XXVI of the Public Health Service Act, which provides grants to states and territories. The ADAP provides medications for the treatment of HIV. Program funds may also be used to purchase health insurance for eligible clients and for services that enhance access, adherence, and monitoring of HIV drug treatments. The following states, territories, and Pacific Island jurisdictions are eligible to apply for RWHAP ADAP funding: All 50 states, the District of Columbia, the Commonwealth of Puerto Rico, the U.S. Virgin Islands, Guam, American Samoa, the Commonwealth of the Northern Mariana Islands, the Republic of Palau, the Federated States of Micronesia, and the Republic of the Marshall Islands. As part of the funding requirements, ADAP grant recipients submit reports concerning information on patients served, eligibility requirements, pharmaceuticals prescribed, pricing and other sources of support to provide HIV medication treatment, cost data, and coordination with Medicaid. The ADAP Data Report (ADR) will be submitted annually and consists of a Grantee Report and a client-level data file. HRSA is requesting an extension of the ADR with minor revisions to patient/client eligibility requirements, which will align data reporting with the Ryan White HIV/AIDS Services Report. Specifically, within Client Variables in the client-level data file:

    • Deletion of variable ID 7, “Transgender” • Addition of “Transgender Male to Female”, “Transgender Female to Male”, and “Transgender Other” as response options for variable ID 6, “Gender”

    Need and Proposed Use of the Information: The RWHAP requires the submission of annual reports by the Secretary of Department of Health and Human Services (HHS) to the appropriate committees of Congress. The collection of recipient-level and client level data enables HRSA to more effectively respond to requests from the Secretary of HHS. In addition, client-level information is needed by HRSA to review program performance and inform strategic planning. Client-level data is also needed to support the monitoring of national goals to end the HIV epidemic: Reduce new HIV infections; increase access to care and optimize health outcomes for people living with HIV; reduce HIV-related health disparities and health inequities; and achieve a more coordinated national response to the HIV epidemic.

    Likely Respondents: State ADAP grant recipients of Ryan White HIV/AIDS Program Part B funding.

    Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose or provide the information requested. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information; to search data sources; to complete and review the collection of information; and to transmit or otherwise disclose the information. The total annual burden hours estimated for this ICR are summarized in the table below.

    Total Estimated Annualized Burden—Hours Form name Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Total
  • responses
  • Average
  • burden per
  • response
  • (in hours)
  • Total burden
  • hours
  • Grantee Report 54 1 54 6 324 Client-level File 54 1 54 81 4,374 Total * 54 54 4,698 * The same respondents complete the Grantee Report and the Client-level Report.
    Amy McNulty, Acting Director, Division of the Executive Secretariat.
    [FR Doc. 2017-16495 Filed 8-4-17; 8:45 am] BILLING CODE 4165-15-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration National Vaccine Injury Compensation Program; List of Petitions Received AGENCY:

    Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS).

    ACTION:

    Notice.

    SUMMARY:

    HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.

    FOR FURTHER INFORMATION CONTACT:

    For information about requirements for filing petitions, and the program in general, contact Lisa L. Reyes, Acting Clerk, United States Court of Federal Claims, 717 Madison Place NW., Washington, DC 20005, (202) 357-6400. For information on HRSA's role in the program, contact the Director, National Vaccine Injury Compensation Program, 5600 Fishers Lane, Rm. 08N146B, Rockville, MD 20857; (301) 443-6593, or visit our Web site at: http://www.hrsa.gov/vaccinecompensation/index.html.

    SUPPLEMENTARY INFORMATION:

    The program provides a system of no-fault compensation for certain individuals who have been injured by specified childhood vaccines. Subtitle 2 of Title XXI of the PHS Act, 42 U.S.C. 300aa-10 et seq., provides that those seeking compensation are to file a petition with the U.S. Court of Federal Claims and to serve a copy of the petition on the Secretary of HHS, who is named as the respondent in each proceeding. The Secretary has delegated this responsibility under the Program to HRSA. The Court is directed by statute to appoint special masters who take evidence, conduct hearings as appropriate, and make initial decisions as to eligibility for, and amount of, compensation.

    A petition may be filed with respect to injuries, disabilities, illnesses, conditions, and deaths resulting from vaccines described in the Vaccine Injury Table (the table) set forth at 42 CFR 100.3. This Table lists for each covered childhood vaccine the conditions that may lead to compensation and, for each condition, the time period for occurrence of the first symptom or manifestation of onset or of significant aggravation after vaccine administration. Compensation may also be awarded for conditions not listed in the table and for conditions that are manifested outside the time periods specified in the table, but only if the petitioner shows that the condition was caused by one of the listed vaccines.

    Section 2112(b)(2) of the PHS Act, 42 U.S.C. 300aa-12(b)(2), requires that “[w]ithin 30 days after the Secretary receives service of any petition filed under section 2111 the Secretary shall publish notice of such petition in the Federal Register.” Set forth below is a list of petitions received by HRSA on June 1, 2017, through June 30, 2017. This list provides the name of petitioner, city and state of vaccination (if unknown then city and state of person or attorney filing claim), and case number. In cases where the Court has redacted the name of a petitioner and/or the case number, the list reflects such redaction.

    Section 2112(b)(2) also provides that the special master “shall afford all interested persons an opportunity to submit relevant, written information” relating to the following:

    1. The existence of evidence “that there is not a preponderance of the evidence that the illness, disability, injury, condition, or death described in the petition is due to factors unrelated to the administration of the vaccine described in the petition,” and

    2. Any allegation in a petition that the petitioner either:

    a. “[S]ustained, or had significantly aggravated, any illness, disability, injury, or condition not set forth in the Vaccine Injury Table but which was caused by” one of the vaccines referred to in the table, or

    b. “[S]ustained, or had significantly aggravated, any illness, disability, injury, or condition set forth in the Vaccine Injury Table the first symptom or manifestation of the onset or significant aggravation of which did not occur within the time period set forth in the table but which was caused by a vaccine” referred to in the table.

    In accordance with Section 2112(b)(2), all interested persons may submit written information relevant to the issues described above in the case of the petitions listed below. Any person choosing to do so should file an original and three (3) copies of the information with the Clerk of the U.S. Court of Federal Claims at the address listed above (under the heading For Further Information Contact), with a copy to HRSA addressed to Director, Division of Injury Compensation Programs, Healthcare Systems Bureau, 5600 Fishers Lane, 08N146B, Rockville, MD 20857. The Court's caption (Petitioner's Name v. Secretary of HHS) and the docket number assigned to the petition should be used as the caption for the written submission. Chapter 35 of title 44, United States Code, related to paperwork reduction, does not apply to information required for purposes of carrying out the Program.

    Dated: July 26, 2017. George Sigounas, Administrator. List of Petitions Filed 1. Sean Oberheim, Littleton, Colorado, Court of Federal Claims No: 17-0725V 2. Alexander M. Beiting, Omaha, Nebraska, Court of Federal Claims No: 17-0726V 3. Ling Chen, Rosedale, Maryland, Court of Federal Claims No: 17-0728V 4. Gerardo Cabello, Los Ranchos de Albuquerque, New Mexico, Court of Federal Claims No: 17-0730V 5. Thomas Hettenbach, Orlando, Florida, Court of Federal Claims No: 17-0731V 6. Alan Peterson, La Crosse, Wisconsin, Court of Federal Claims No: 17-0732V 7. Christopher Hill, San Diego, California, Court of Federal Claims No: 17-0734V 8. Kebba Dampha, East Lansing, Michigan, Court of Federal Claims No: 17-0735V 9. Carolyn Orrell, Charlotte, North Carolina, Court of Federal Claims No: 17-0736V 10. Rachel Knura on behalf of Kole Knura, Munster, Indiana, Court of Federal Claims No: 17-0737V 11. Jennifer Kreger, Zimmerman, Minnesota, Court of Federal Claims No: 17-0742V 12. Michael J. Gordon on behalf of J.M.G., Santa Monica, California, Court of Federal Claims No: 17-0743V 13. Cafilliar Perdue, Jackson, Mississippi, Court of Federal Claims No: 17-0746V 14. Jasmin A. Lopez, Rockville, Connecticut, Court of Federal Claims No: 17-0748V 15. Ann E. Kleva, Notre Dame, Indiana, Court of Federal Claims No: 17-0749V 16. Penny Lynn Burke, North Bend, Washington, Court of Federal Claims No: 17-0750V 17. Katherine Tierney and Kevin Tierney on behalf of C. T., Brighton, Michigan, Court of Federal Claims No: 17-0751V 18. Selena Despotovic, St. Petersburg, Florida, Court of Federal Claims No: 17-0752V 19. Agnes Johns, St. Petersburg, Florida, Court of Federal Claims No: 17-0753V 20. Ronald Devingo, Toms River, New Jersey, Court of Federal Claims No: 17-0754V 21. Joseph Baldwin, Franklin, Tennessee, Court of Federal Claims No: 17-0756V 22. Tracy Middlebrooks, Scottsboro, Alabama, Court of Federal Claims No: 17-0757V 23. Stephen Waldorf, Washington, District of Columbia, Court of Federal Claims No: 17-0758V 24. Nicholas Gallelli, East Orange, New Jersey, Court of Federal Claims No: 17-0759V 25. Dorothy Rowan, Boise, Idaho, Court of Federal Claims No: 17-0760V 26. Lisa Knapp, Wichita Falls, Texas, Court of Federal Claims No: 17-0764V 27. Barbara Wellen, Port Orange, Florida, Court of Federal Claims No: 17-0767V 28. Mark Simmer, Washington, District of Columbia, Court of Federal Claims No: 17-0769V 29. Hedy Glover, St. Louis, Missouri, Court of Federal Claims No: 17-0770V 30. Tammy L. Douse, Kettle Falls, Washington, Court of Federal Claims No: 17-0771V 31. Rebecca DeRitis on behalf of B.D., New York, New York, Court of Federal Claims No: 17-0772V 32. Carlos Orduz, Yonkers, New York, Court of Federal Claims No: 17-0773V 33. Amy NMN Hayes on behalf of A. T. A., Angier, North Carolina, Court of Federal Claims No: 17-0774V 34. Richard Scott, Indianapolis, Indiana, Court of Federal Claims No: 17-0775V 35. Diane Fedorchak, Washington, District of Columbia, Court of Federal Claims No: 17-0776V 36. Constance J. Sabins, Harrisburg, North Carolina, Court of Federal Claims No: 17-0778V 37. Jerry Sanders, Ozark, Alabama, Court of Federal Claims No: 17-0779V 38. Robert Sauer, Pennington, New Jersey, Court of Federal Claims No: 17-0780V 39. Pamela Kirby, Washington, District of Columbia, Court of Federal Claims No: 17-0782V 40. Dionni De La Cruz, Washington, District of Columbia, Court of Federal Claims No: 17-0783V 41. Ashley Potts, Jacksonville, Florida, Court of Federal Claims No: 17-0784V 42. John Colapietro, Cocoa Beach, Florida, Court of Federal Claims No: 17-0785V 43. Valisha Carrington, San Antonio, Texas, Court of Federal Claims No: 17-0786V 44. Kristi Arrant, Lake Charles, Louisiana, Court of Federal Claims No: 17-0788V 45. Jason Kahn, West Lafayette, Indiana, Court of Federal Claims No: 17-0789V 46. Anna Ballard, Macon, Georgia, Court of Federal Claims No: 17-0790V 47. Karen Williams, Winfield, Alabama, Court of Federal Claims No: 17-0791V 48. Laura Kalajdzic and Bojan Kalajdzic on behalf of A. K., Aurora, Colorado, Court of Federal Claims No: 17-0792V 49. Kathleen Knox, Lancaster, South Carolina, Court of Federal Claims No: 17-0794V 50. Deloris Harrell, Montgomery, Alabama, Court of Federal Claims No: 17-0795V 51. Leo Cahill on behalf of Valena Yvonne Cahill, Washington, District of Columbia, Court of Federal Claims No: 17-0796V 52. Samuel Hutchens, Scottsdale, Arizona, Court of Federal Claims No: 17-0797V 53. Ashok Pahwa, Rye Brook, New York, Court of Federal Claims No: 17-0799V 54. Daron Nelson, Layton, Utah, Court of Federal Claims No: 17-0800V 55. Jodie L. Paschall-Majerus, Vancouver, Washington, Court of Federal Claims No: 17-0801V 56. Charlotte Porch, Houston, Texas, Court of Federal Claims No: 17-0802V 57. Charles Randall, Hillsdale, Michigan, Court of Federal Claims No: 17-0803V 58. Julia Hayes, West Chester, Pennsylvania, Court of Federal Claims No: 17-0804V 59. Suzanne Dyer, Little River, South Carolina, Court of Federal Claims No: 17-0805V 60. William Fuller, Summerville, South Carolina, Court of Federal Claims No: 17-0806V 61. Teresa Fowler, Boston, Massachusetts, Court of Federal Claims No: 17-0809V 62. Alyssa Hilt, Dresher, Pennsylvania, Court of Federal Claims No: 17-0810V 63. Catherine Fry, Greenbelt, Maryland, Court of Federal Claims No: 17-0811V 64. Lynette Pestel, Springfield, Illinois, Court of Federal Claims No: 17-0814V 65. Shirley Garrett, Pidgeon Forge, Tennessee, Court of Federal Claims No: 17-0815V 66. Lilia Tellez-Garcia, Dresher, Pennsylvania, Court of Federal Claims No: 17-0816V 67. Christopher O'Hern, Washington, District of Columbia, Court of Federal Claims No: 17-0818V 68. Cherlanda Sheppard, Detroit, Michigan, Court of Federal Claims No: 17-0819V 69. Heidi Theis, Ephrata, Pennsylvania, Court of Federal Claims No: 17-0820V 70. Karen Hopseker, Rochester, New York, Court of Federal Claims No: 17-0821V 71. Felica Thomas on behalf of Zaire Corvell Thomas, Deceased, Madison, Wisconsin, Court of Federal Claims No: 17-0822V 72. Deanna Williams, San Jose, California, Court of Federal Claims No: 17-0830V 73. Deborah Forbes, Arlington, Texas, Court of Federal Claims No: 17-0832V 74. Audrey Rebollo, Norristown, Pennsylvania, Court of Federal Claims No: 17-0833V 75. Kendra Calvert on behalf of S. C., Fort Worth, Texas, Court of Federal Claims No: 17-0834V 76. Brent Langley, Mechanicsburg, Pennsylvania, Court of Federal Claims No: 17-0837V 77. Judy Echols, Birmingham, Alabama, Court of Federal Claims No: 17-0838V 78. Connie Osborn, Washington, District of Columbia, Court of Federal Claims No: 17-0839V 79. Patricia M. Browne, Rincon, Georgia, Court of Federal Claims No: 17-0840V 80. Timothy McClusky, Boston, Massachusetts, Court of Federal Claims No: 17-0841V 81. Michael Goodin, Portsmouth, New Hampshire, Court of Federal Claims No: 17-0844V 82. Bambi Pascuzzi, Trafford, Pennsylvania, Court of Federal Claims No: 17-0846V 83. Zachary Childree and Megan Akers on behalf of B. C., Milton, Florida, Court of Federal Claims No: 17-0848V 84. Patricia Dillon, San Francisco, Alaska, Court of Federal Claims No: 17-0849V 85. Joshua Yeargin and Sheri Yeargin on behalf of A Y, Washington, District of Columbia, Court of Federal Claims No: 17-0850V 86. Jeffrey Levine and Toni Ann Levine on behalf of A. L., Clifton, New Jersey, Court of Federal Claims No: 17-0851V 87. Roseanna Johnson, Little Rock, Arkansas, Court of Federal Claims No: 17-0852V 88. Chelsie Decker, Indianapolis, Indiana, Court of Federal Claims No: 17-0853V 89. Reynaldo Belmonte, Jr., North Bend, Washington, Court of Federal Claims No: 17-0856V 90. Erwin Mansilla, Gardena, California, Court of Federal Claims No: 17-0861V 91. Nicole Carion, Washington, District of Columbia, Court of Federal Claims No: 17-0862V 92. Ashley Scott, Washington, District of Columbia, Court of Federal Claims No: 17-0863V 93. Lindsey Kueng, Washington, District of Columbia, Court of Federal Claims No: 17-0864V 94. Billy R. Dehart, Leesville, Louisiana, Court of Federal Claims No: 17-0870V 95. Katie Wiggins, Washington, District of Columbia, Court of Federal Claims No: 17-0871V 96. Stephanie Easterling on behalf of G. E., New York, New York, Court of Federal Claims No: 17-0872V 97. Benita Goldstein on behalf of Stewart G. Goldstein, Deceased, West Palm Beach, Florida, Court of Federal Claims No: 17-0873V 98. Thomas Zerwas, Elk River, Minnesota, Court of Federal Claims No: 17-0874V 99. Brandy McCoy on behalf of E. M., Mooresville, North Carolina, Court of Federal Claims No: 17-0875V 100. Virginia Lara, Choctaw, Oklahoma, Court of Federal Claims No: 17-0880V 101. Jodi Eads, Decatur, Indiana, Court of Federal Claims No: 17-0881V 102. Deanne Doane, Houston, Texas, Court of Federal Claims No: 17-0882V 103. Gladys Highfield, Dongola, Illinois, Court of Federal Claims No: 17-0883V 104. Martha Tapia, Rialto, California, Court of Federal Claims No: 17-0884V 105. Carroll Spicer, Eugene, Oregon, Court of Federal Claims No: 17-0885V 106. Christina Nelson, Manhattan, Kansas, Court of Federal Claims No: 17-0886V 107. Michael L. Winters, Knoxville, Tennessee, Court of Federal Claims No: 17-0887V 108. Juanita Cruey, Kenosha, Wisconsin, Court of Federal Claims No: 17-0888V 109. Jackie Dwayne Damron on behalf of Jack Damron, Deceased, Hendersonville, Tennessee, Court of Federal Claims No: 17-0890V 110. Rochelle Belt, Philadelphia, Pennsylvania, Court of Federal Claims No: 17-0891V 111. Barbara Fantell and Scott Fantell on behalf of H. F., Cape Coral, Florida, Court of Federal Claims No: 17-0892V 112. Katie R. Peterson, Salt Lake City, Utah, Court of Federal Claims No: 17-0893V 113. Derek Molina, Mt. Pleasant, Texas, Court of Federal Claims No: 17-0895V 114. Destiny Duncan, Bluffton, South Carolina, Court of Federal Claims No: 17-0896V 115. Timothy Woods, Anamosa, Iowa, Court of Federal Claims No: 17-0897V
    [FR Doc. 2017-16584 Filed 8-4-17; 8:45 am] BILLING CODE 4165-15-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Meeting of the Advisory Commission on Childhood Vaccines AGENCY:

    Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS).

    ACTION:

    Notice of meeting.

    SUMMARY:

    In accordance with section 10(a)(2) of the Federal Advisory Committee Act, notice is hereby given that a meeting is scheduled for the Advisory Commission on Childhood Vaccines (ACCV). This meeting will be open to the public. Information about the ACCV and the agenda for this meeting can be obtained by accessing the following Web site: http://www.hrsa.gov/advisorycommittees/childhoodvaccines/index.html.

    DATES:

    The meeting will be held on September 8, 2017, at 10:00 a.m. EDT.

    ADDRESSES:

    The address for the meeting is 5600 Fishers Lane, Rockville, MD, Conference Room 5N54. The public can join the meeting by:

    1. (In Person) Persons interested in attending the meeting in person are encouraged to submit a written notification to: Annie Herzog, Division of Injury Compensation Programs (DICP), Healthcare Systems Bureau (HSB), HRSA, Rm. 8N146B, 5600 Fishers Lane, Rockville, Maryland 20857 or email: [email protected] Since this meeting is held in a federal government building, attendees will need to go through a security check to enter the building and participate in the meeting. This written notification is encouraged so that a list of attendees can be provided to make entry through security quicker. Persons may attend in person without providing written notification, but their entry into the building may be delayed due to security checks and the requirement to be escorted to the meeting by a federal government employee. To request an escort to the meeting after entering the building, call Amber Johnson at (301) 443-0129.

    2. (Audio Portion) Call the conference phone number (800) 369-1833 and providing the following information:

    Leader Name: Dr. Narayan Nair

    Password: 6706374

    3. (Visual Portion) Connect to the ACCV Adobe Connect Pro Meeting using the following URL: https://hrsa.connectsolutions.com/accv/. Participants should call and connect 15 minutes prior to the meeting to allow time for the logistics to be set-up. If you have never attended an Adobe Connect meeting, please test your connection using the following URL: https://hrsa.connectsolutions.com/common/help/en/support/meeting_test.htm.

    Get a quick overview of the software at: http://www.adobe.com/go/connectpro_overview.

    FOR FURTHER INFORMATION CONTACT:

    Anyone requesting information regarding the ACCV should contact Annie Herzog, Program Analyst, DICP, HRSA in one of three ways: (1) Send a request to the following address: Annie Herzog, Program Analyst, DICP, HRSA, 5600 Fishers Lane, 8N146B, Rockville, Maryland 20857; (2) call (301) 443-6593; or (3) send an email to [email protected]

    The ACCV will meet on Friday, September 8, 2017, beginning at 10:00 a.m. in the 5600 Fishers Lane Building, Rockville, Maryland 20857; however, meeting times and locations could change. For the latest information regarding meeting start time and location, please check the ACCV Web site: http://www.hrsa.gov/advisorycommittees/childhoodvaccines/index.html.

    SUPPLEMENTARY INFORMATION:

    The ACCV was established by section 2119 of the Public Health Service Act (the Act) (42 U.S.C. 300aa-19), as enacted by Public Law (Pub. L.) 99-660, and as subsequently amended, and advises the Secretary of HHS (the Secretary) on issues related to implementation of the National Vaccine Injury Compensation Program (VICP).

    Activities of the ACCV also include: Recommending changes to the Vaccine Injury Table on its own initiative or as the result of the filing of a petition; advising the Secretary in implementing section 2127 of the Act regarding the need for childhood vaccination products that result in fewer or no significant adverse reactions; surveying federal, state, and local programs and activities related to gathering information on injuries associated with the administration of childhood vaccines, including the adverse reaction reporting requirements of section 2125(b) of the Act; advising the Secretary on the methods of obtaining, compiling, publishing, and using credible data related to the frequency and severity of adverse reactions associated with childhood vaccines; consulting on the development or revision of Vaccine Information Statements; and recommending to the Director of the National Vaccine Program research related to vaccine injuries which should be conducted to carry out the VICP.

    The agenda items for the meeting will include, but are not limited to, updates from DICP, Department of Justice, National Vaccine Program Office, Immunization Safety Office (Centers for Disease Control and Prevention), National Institute of Allergy and Infectious Diseases (National Institutes of Health) and Center for Biologics, Evaluation and Research (Food and Drug Administration). A draft agenda and additional meeting materials will be posted on the ACCV Web site (http://www.hrsa.gov/advisorycommittees/childhoodvaccines/index.html) prior to the meeting. Agenda items are subject to change as priorities dictate.

    Members of the public will have the opportunity to provide comments. Oral comments will be honored in the order they are requested and may be limited as time allows. Requests to make oral comments or provide written comments to the ACCV should be sent to Annie Herzog using the address and phone number above by September 4, 2017. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify Annie Herzog, using the address and phone number above at least 10 days prior to the meeting.

    Amy McNulty, Acting Director, Division of the Executive Secretariat.
    [FR Doc. 2017-16582 Filed 8-4-17; 8:45 am] BILLING CODE 4165-15-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Announcement of Meeting of the Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2030 AGENCY:

    Office of Disease Prevention and Health Promotion, Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services.

    ACTION:

    Notice.

    SUMMARY:

    The U.S. Department of Health and Human Services (HHS) announces the next meeting of the Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2030 (Committee). The meeting is open to the public and will be held in the Washington, DC metropolitan area. The Committee is working to accomplish its mission to provide independent advice based on current scientific evidence for use by the Secretary of the U.S. Department of Health and Human Services or a designated representative in the development of Healthy People 2030.

    DATES:

    The Committee will meet on September 6, 2017, from 8:30 a.m. to 5:00 p.m. Eastern Time (ET), and September 7, 2017, from 8:30 a.m. to 2:30 p.m. ET.

    ADDRESSES:

    The meeting will be held at the 20 F Street NW. Conference Center, located at 20th F Street NW., Washington, DC 20001. To register to attend the meeting or deliver oral public testimony, please visit the Healthy People Web site at https://www.healthypeople.gov.

    FOR FURTHER INFORMATION CONTACT:

    Emmeline Ochiai, Designated Federal Officer, Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2030, U.S. Department of Health and Human Services, Office of the Assistant Secretary for Health, Office of Disease Prevention and Health Promotion, 1101 Wootton Parkway, Rm. LL-100, Rockville, MD 20852, (240) 453-8280 (telephone), (240) 453-8281 (fax). Additional information is available on the Healthy People Web site at https://www.healthypeople.gov.

    SUPPLEMENTARY INFORMATION:

    Appointed Committee Members: The names and biographies of the appointed Committee members are available at https://www.healthypeople.gov/2020/about/history-development/healthy-people-2030-advisory-committee.

    Purpose of Meeting: In accordance with Federal Advisory Committee Act and to promote transparency of the process, deliberations of the Committee will occur in a public forum. At this meeting, the Committee will continue its deliberations from the last public meeting.

    Background: The Committee, a federal advisory committee, is charged with issuing recommendations for the Secretary regarding the development and implementation of national health promotion and disease prevention objectives for 2030. The Committee will discuss the nation's health promotion and disease prevention objectives and will provide recommendations to improve health status and reduce health risks for the nation by the year 2030. The Committee will develop recommendations regarding the criteria for identifying a more focused set of measurable, nationally representative objectives for improving the health of the nation by the year 2030 and recommendations for engaging stakeholders in the implementation and achievement of the objectives. The Committee's advice must assist the Secretary in reducing the number of objectives, while ensuring that the selection criteria identifies the most critical public health issues that are high-impact priorities supported by current national data. Through the Healthy People initiative, HHS leverages scientific insights and lessons from the past decade, along with new knowledge of current data, trends, and innovations, to develop the next iteration of national health promotion and disease prevention objectives. Healthy People provides science-based, 10-year national objectives for promoting health and preventing disease. Since 1979, Healthy People has set and monitored national health objectives that meet a broad range of health needs, encourage collaboration across sectors, guide individuals toward making informed health decisions, and measure the impact of our prevention and health promotion activities. Healthy People 2030 health objectives will reflect assessments of major risks to health and wellness, changing public health priorities, and emerging technologies related to our nation's health preparedness and prevention.

    Meeting Agenda: The meeting agenda will include (a) opportunity for the public to give oral testimony, (b) review of Committee work since the last public meeting, and (c) plans for future Committee work.

    Public Participation at Meeting: Members of the public are invited to attend the Committee meeting. To attend the Committee meeting, individuals must pre-register at the Healthy People Web site at http://www.healthypeople.gov. Registrations must be completed by 5:00 p.m. ET on September 1, 2017. Space for the meeting is limited and registration will be accepted until maximum room capacity is reached. A waiting list will be maintained should registrations exceed room capacity. Individuals on the waiting list will be contacted as additional space for the meeting becomes available. Registration questions may be directed to: Jim Nakayama at [email protected], or (240) 672-4011.

    Public Comments and Meeting Documents: An opportunity to present to the Committee oral comments regarding the proposed Healthy People 2030 vision, mission, overarching goals, foundational principles, and plan of action will be provided at this meeting. Those wishing to present oral comment must pre-register at the Healthy People Web site at www.healthypeople.gov by 5:00 p.m. ET, on August 21, 2017, and must submit a written copy of their oral testimony by 5:00 p.m. ET, on August 30, 2017, to Jim Nakayama at [email protected]. The opportunity to deliver oral testimony is limited. Those presenting oral comments will have two (2) minutes to address the Committee. Guidelines for public comment submissions can be viewed at https://www.healthypeople.gov/2020/About-Healthy-People/Development-Healthy-People-2030/Public-Comment. Written public comments can be submitted and/or viewed at https://www.healthypeople.gov/2020/About-Healthy-People/Development-Healthy-People-2030/Public-Comment/Items-for-comment. Documents pertaining to Committee deliberations, including meeting agendas and summaries are available at https://www.healthypeople.gov/2020/About-Healthy-People/Development-Healthy-People-2030/Committee-Meetings. Questions regarding public comment may be directed to: Jim Nakayama at [email protected] or (240) 672-4011.

    Authority: 42 U.S.C. 217a. The Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2030 is governed by provisions of the Federal Advisory Committee Act (FACA), Public Law 92-463, as amended (5 U.S.C., App.) which sets forth standards for the formation and use of federal advisory committees.

    Dated: August 2, 2017. Don Wright, Deputy Assistant Secretary for Health (Disease Prevention and Health Promotion).
    [FR Doc. 2017-16608 Filed 8-4-17; 8:45 am] BILLING CODE 4150-32-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Notice of Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the National Advisory Child Health and Human Development Council.

    The meeting will be open to the public as indicated below, with attendance limited to space available. A portion of this 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 for the review and discussion of grant applications. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the contact person listed below in advance of the meeting.

    Name of Committee: National Advisory Child Health and Human Development Council.

    Date: September 14, 2017.

    Open: September 14, 2017.

    Time: 8:00 a.m. to 12:00 p.m.

    Agenda: The agenda will include opening remarks, administrative matters, Director's Report, Division of Extramural Research Report and, other business of the Council.

    Place: National Institutes of Health, Building 31, C-Wing, Conference Room 6, 9000 Rockville Pike, Bethesda, MD 20892.

    Closed: September 14, 2017.

    Time: 1:00 p.m. to Adjournment.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, Building 31, C-Wing, Conference Room 6, 9000 Rockville Pike, Bethesda, MD 20892.

    Contact Person: Della Hann, Ph.D., Director, Division of Extramural Research, Eunice Kenney Shriver, National Institute of Child Health and Human Development, NIH, 6710 Rockledge Blvd., MSC 7002, Bethesda, MD 20892, 301-496-8535.

    Any interested person may file written comments with the committee by forwarding the statement to the contact person listed on this notice. The statement should include the name, address, telephone number, and when applicable, the business or professional affiliation of the interested person.

    In the interest of security, NIH has instituted stringent procedures for entrance onto the NIH campus. All visitor vehicles, including taxis, hotel, and airport shuttles, will be inspected before being allowed on campus. Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver's license, or passport) and to state the purpose of their visit.

    In order to facilitate public attendance at the open session of Council in the main meeting room, Conference Room 6, please contact Ms. Lisa Kaeser, Program and Public Liaison Office, NICHD, at 301-496-0536 to make your reservation, additional seating will be available in the meeting overflow rooms, Conference Rooms 7 and 8. Individuals will also be able to view the meeting via NIH Videocast. Please go to the following link for Videocast access instructions at: http://www.nichd.nih.gov/about/advisory/nachhd/Pages/virtual-meeting.aspx.

    (Catalogue of Federal Domestic Assistance Program Nos. 93.864, Population Research; 93.865, Research for Mothers and Children; 93.929, Center for Medical Rehabilitation Research; 93.209, Contraception and Infertility Loan Repayment program, National Institutes of Health, HHS).
    Dated: August 1, 2017. Michelle Trout, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2017-16520 Filed 8-4-17; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting

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

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

    Name of Committee: National Institute of Biomedical Imaging and Bioengineering Special Emphasis Panel; JHU Translational Immuno-Engineering BTRC (2018/01).

    Date: September 26, 2017.

    Time: 09:00 a.m. to 8:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, Two Democracy Plaza, Suite 920, 6707 Democracy Boulevard, Bethesda, MD 20892 (Virtual Meeting).

    Contact Person: John K. Hayes, Ph.D., Scientific Review Officer, 6707 Democracy Blvd., Suite 959, Democracy Two, Bethesda, MD 20892, (301) 451-3398, [email protected]

    Dated: August 1, 2017. David Clary, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2017-16533 Filed 8-4-17; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting

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

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

    Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel; Pilot Clinical Trials Targeting HIV-1 Reservoirs in Children (U01).

    Date: August 23, 2017.

    Time: 11:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 5601 Fishers Lane, Rockville, MD 20892 (Telephone Conference Call).

    Contact Person: J. Bruce Sundstrom, Ph.D., Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, Rm. 3G11A, National Institutes of Health/NIAID, 5601 Fishers Lane, MSC 9823, Bethesda, MD 20892-9823, 240-669-5045, [email protected]

    (Catalogue of Federal Domestic Assistance Program Nos. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, Microbiology and Infectious Diseases Research, National Institutes of Health, HHS)
    Dated: August 1, 2017. Sylvia L. Neal, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2017-16523 Filed 8-4-17; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting

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

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

    Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel; Asthma and Allergic Diseases Cooperative Research Centers.

    Date: September 7-14, 2017.

    Time: 12:00 p.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: The William F. Bolger Center, 9600 Newbridge Drive, Potomac, MD 20854.

    Contact Person: Paul A. Amstad, Ph.D., Scientific Review Officer, Scientific Review Program, NIAID/NIH/DHHS, Division of Extramural Activities, Room 3G41, 5601 Fishers Lane, Bethesda, MD 20892-7616, 240-669-5067, [email protected]

    (Catalogue of Federal Domestic Assistance Program Nos. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, Microbiology and Infectious Diseases Research, National Institutes of Health, HHS)
    Dated: August 1, 2017. Sylvia L. Neal, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2017-16522 Filed 8-4-17; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive Patent License: The Development of a Bispecific, Biparatopic Antibody-Drug Conjugate to GPC3 for the Treatment of Human Liver Cancers AGENCY:

    National Institutes of Health, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The National Cancer Institute, National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to Salubris Biotherapeutics, Inc. (Salubris), located in Gaithersburg, Maryland, to practice the inventions embodied in the patent applications listed in the SUPPLEMENTARY INFORMATION section of this notice.

    DATES:

    Only written comments and/or applications for a license which are received by the NCI Technology Transfer Center on or before August 22, 2017 will be considered.

    ADDRESSES:

    Requests for copies of the patent applications, inquiries, and comments relating to the contemplated Exclusive Patent License should be directed to: David A. Lambertson, Ph.D., Senior Licensing and Patenting Manager, NCI Technology Transfer Center, 9609 Medical Center Drive, RM 1E530 MSC 9702, Bethesda, MD 20892-9702 (for business mail), Rockville, MD 20850-9702; Telephone: (240) 276-6467; Email: [email protected]

    SUPPLEMENTARY INFORMATION:

    The following represents the intellectual property to be licensed under the prospective agreement: (A) U.S. Provisional Patent Application 61/654,232 entitled “High-affinity Monoclonal Antibodies To Glypican-3 And Use Thereof” [HHS Ref. E-136-2012/0-US-01], PCT Patent Application PCT/US2013/043633 entitled “High-affinity Monoclonal Antibodies To Glypican-3 And Use Thereof” [HHS Ref. E-136-2012/0-PCT-02], Chinese Patent Application 201380039993.7 entitled “High-affinity Monoclonal Antibodies To Glypican-3 And Use Thereof” [HHS Ref. E-136-2012/0-CN-03], Japanese Patent Application 2015-515243 entitled “High-affinity Monoclonal Antibodies To Glypican-3 And Use Thereof” [HHS Ref. E-136-2012/0-JP-04], South Korean Patent Application 10-2014-7037046 entitled “High-affinity Monoclonal Antibodies To Glypican-3 And Use Thereof” [HHS Ref. E-136-2012/0-KR-05], Singapore Patent Application 11201407972R entitled “High-affinity Monoclonal Antibodies To Glypican-3 And Use Thereof” [HHS Ref. E-136-2012/0-SG-06], and United States Patent 9,409,994 entitled “High-affinity Monoclonal Antibodies To Glypican-3 And Use Thereof” [HHS Ref. E-136-2012/0-US-07], and all continuing U.S. and foreign patents/patent applications for the technology family; and (B) U.S. Provisional Patent Application 61/477,020 entitled “Human Monoclonal Antibody Specific for Glypican-3 And Use Thereof” [HHS Ref. E-130-2011/0-US-01], PCT Patent Application PCT/US2012/034186 entitled “Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof” [HHS Ref. E-130-2011/0-PCT-02], Chinese Patent 201280029201.3 entitled “Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof” [HHS Ref. E-130-2011/0-CN-03], European Patent 2699603 entitled “Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof” [HHS Ref. E-130-2011/0-EP-04], and validated in France [HHS Ref. E-130-2011/0-FR-09], Germany [HHS Ref. E-130-2011/0-DE-08] and the United Kingdom [HHS Ref. E-130-2011/0-GB-10] and lodged in Hong Kong [HHS Ref. E-130-2011/0-HK-11], United States Patent 9,206,257 entitled “Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof” [HHS Ref. E-130-2011/0-US-05], United States Patent 9,394,364, entitled “Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof” [HHS Ref. E-130-2011/0-US-06], European Patent Application 15188264.4 entitled “Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof” [HHS Ref. E-130-2011/0-EP-07], United States Patent Application 15/090,873 entitled “Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof” [HHS Ref. E-130-2011/0-US-12], Chinese Patent Application 201610290837.3 entitled “Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof” [HHS Ref. E-130-2011/0-CN-13], European Patent Application 16166924.7 entitled “Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof” [HHS Ref. E-130-2011/0-EP-14], and all continuing U.S. and foreign patents/patent applications for the technology family, to Salubris. The patent rights in these inventions have been assigned to and/or exclusively licensed to the Government of the United States of America.

    With respect to persons who have an obligation to assign their right, title and interest to the Government of the United States of America, the patent rights in these inventions have been assigned to the Government of the United States of America.

    The prospective Exclusive Patent License territory may be worldwide for the following field of use:

    The development and commercialization of a bispecific, biparatopic antibody-drug conjugate (ADC) having:

    (1) The CDR sequences of both the hYP7 and HN3 anti-GPC3 monoclonal antibodies; and

    (2) a microtubule inhibitor payload including, but not limited to, auristatin and mertansine;

    for the treatment of human liver cancer. The licensed field of use excludes any (a) non-specified immunoconjugates, including, but not limited to, chimeric antigen receptors (CARs) and variants thereof, immunotoxins, ADCs with payloads that are not microtubule inhibitors, and monospecific versions of the aforementioned immunoconjugates, and (b) unconjugated antibodies.

    The present inventions to be licensed concern monoclonal antibodies that are specific for the cell surface domain of GPC3: HN3 and hYP7. These antibodies can potentially be used for the treatment of GPC3-expressing cancers such as HCC. In the subject situation, the antibodies can be used in conjunction to target a toxic payload specifically to GPC3-expressing cells, leading to the selective destruction of the cancerous cells.

    This notice is made in accordance with 35 U.S.C. 209 and 37 CFR part 404. The prospective Exclusive Patent License will be royalty bearing and may be granted unless within fifteen (15) days from the date of this published notice, the National Cancer Institute receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404.

    Complete applications for a license in the prospective field of use that are timely filed in response to this notice will be treated as objections to the grant of the contemplated Exclusive Patent License. Comments and objections submitted to this notice will not be made available for public inspection and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552.

    Dated: July 25, 2017. Richard U. Rodriguez, Associate Director, Technology Transfer Center, National Cancer Institute.
    [FR Doc. 2017-16525 Filed 8-4-17; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Aging; Notice of Closed Meeting

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

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

    Name of Committee: National Institute on Aging Special Emphasis Panel; Drugs Targeting Pathways of Aging.

    Date: September 13, 2017.

    Time: 3:00 p.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institute on Aging, Gateway Building, 2W200, 7201 Wisconsin Avenue, Bethesda, MD 20892 (Telephone Conference Call).

    Contact Person: Anita H. Undale, Ph.D., MD, Scientific Review Branch, National Institute on Aging, Gateway Building, Suite 2W200, 7201 Wisconsin Avenue, Bethesda, MD 20892, 240-747-7825, [email protected]

    (Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging Research, National Institutes of Health, HHS)
    Dated: August 1, 2017. David Clary, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2017-16521 Filed 8-4-17; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive Patent License: MicroRNA Therapeutics for Treating Squamous Cell Carcinomas AGENCY:

    National Institutes of Health, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The National Heart, Lung and Blood Institute (NHLBI), National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to MiRecule, Inc., located in Rockville, Maryland, to practice the inventions embodied in the patent applications listed in the SUPPLEMENTARY INFORMATION section of this notice.

    DATES:

    Only written comments and/or applications for a license which are received by the NHLBI Office of Technology Transfer and Development August 22, 2017 will be considered.

    ADDRESSES:

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

    SUPPLEMENTARY INFORMATION:

    The following represents the intellectual property to be licensed under the prospective agreement: HHS Ref. No. E-043-2016/0, including provisional patent application 62/304,844 filed March 7, 2016 and International Patent Application PCT/US2017/021178 filed March 7, 2017 both entitled “MicroRNAs And Methods Of Their Use,” and all continuing U.S. and foreign patents/patent applications for the technology family, to MiRecule. The patent rights in these inventions have been assigned to and/or exclusively licensed to the Government of the United States of America.

    With respect to persons who have an obligation to assign their right, title and interest to the Government of the United States of America, the patent rights in these inventions have been assigned to the Government of the United States of America.

    The prospective Exclusive Patent License territory may be worldwide for the following field of use: MicroRNA therapeutics for squamous cell carcinomas.

    The invention relates to the use of microRNAs (miRs), miR mimics, miR mimetics, and a combination thereof as anti-proliferative cancer therapeutics. In this case, miRs will be administered in a form complexed with nanoparticles in the form of liposomes decorated with anti-transferrin receptor (TfR) scFv fragments. Generally, miRs are a highly conserved class of small RNA molecules (about 18-24bp) that primarily bind the 3'-UTR region of mRNA molecules and either block translation or promote nuclease mediated degradation. The inventors found that mimics or mimetics derived from several members of the miR-30-5p family; and miR-30a-5p and miR-30e-5p, have potential as anti-proliferative therapeutics in cancers including but not limited to squamous cell carcinomas and currently have a CRADA with NIDCD exploring their uses in treating head and neck squamous cell carcinoma (HNSSC). In an in vivo proof-of-concept using a murine xenograft tumor model for HNSSC, the inventors demonstrated that intraperitoneal administration of a nanoliposome formulated with an anti-transferrin receptor antibody fragment and a synthetic miR-30a-5p mimic strongly delayed tumor growth. Other anti-cancer miR therapeutic mimics can be combines with miR-30 including miR-145-5p, miR-26a-5p, miR-26b-5p, miR-375-5p, miR-30b-5p, miR-30d-5p, or miR-338-3p. Modes of administration can be by intravenous injection, intraperitoneal injection, subcutaneous injection, or intratumoral injection. Therapeutic design employing miR mimicry focuses on nucleic acid modifications that exhibit better cytotoxicity than unmodified miRs or commercially available mimics. For example, it is accepted that modification of the 2' position of individual nucleic acids in an oligonucleotide can improve affinity to complementary strands and confer resistance to nucleases and reduce adverse immunogenic reactions. By way of another example, bases 1, 6, and 20 of a passenger strand miR can be mutated to increase the stability of the resulting duplex; however, these mutation sites may differ from one therapeutic miR to another. Tumor suppressing miR mimics can be synergistically combined with standard chemo- and radiation therapies in an anti-cancer regimen.

    This notice is made in accordance with 35 U.S.C. 209 and 37 CFR part 404. The prospective Exclusive Patent License will be royalty bearing and may be granted unless within fifteen (15) days from the date of this published notice, the NHLBI receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404.

    Complete applications for a license in the prospective field of use that are timely filed in response to this notice will be treated as objections to the grant of the contemplated Exclusive Patent License. Comments and objections submitted to this notice will not be made available for public inspection and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552.

    Dated: July 25, 2017. Michael Shmilovich, Senior Licensing and Patenting Manager, NHLBI Office of Technology Transfer and Development.
    [FR Doc. 2017-16524 Filed 8-4-17; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard [Docket No. USCG-2017-0114] Information Collection Request to Office of Management and Budget; OMB Control Number: 1625-0062 AGENCY:

    Coast Guard, DHS.

    ACTION:

    Sixty-day notice requesting comments.

    SUMMARY:

    In compliance with the Paperwork Reduction Act of 1995, the U.S. Coast Guard intends to submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB), Office of Information and Regulatory Affairs (OIRA), requesting a Reinstatement, without change, of a previously approved collection for which approval has expired for the following collection of information: 1625-0062, Approval of Alterations to Marine Portable Tanks; Approval of Non-Specification Portable Tanks without change. Our ICR describes the information we seek to collect from the public. Before submitting this ICR to OIRA, the Coast Guard is inviting comments as described below.

    DATES:

    Comments must reach the Coast Guard on or before October 6, 2017.

    ADDRESSES:

    You may submit comments identified by Coast Guard docket number [USCG-2017-0114] to the Coast Guard using the Federal eRulemaking Portal at http://www.regulations.gov. See the “Public participation and request for comments” portion of the SUPPLEMENTARY INFORMATION section for further instructions on submitting comments.

    A copy of the ICR is available through the docket on the Internet at http://www.regulations.gov. Additionally, copies are available from: Commandant (CG-612), Attn: Paperwork Reduction Act Manager, U.S. Coast Guard, 2703 Martin Luther King Jr. Ave. SE., Stop 7710, Washington, DC 20593-7710.

    FOR FURTHER INFORMATION CONTACT:

    Mr. Anthony Smith, Office of Information Management, telephone 202-475-3532, or fax 202-372-8405, for questions on these documents.

    SUPPLEMENTARY INFORMATION: Public Participation and Request for Comments

    This Notice relies on the authority of the Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to OIRA seeking the approval, extension, or renewal of a Coast Guard collection of information (Collection). The ICR contains information describing the Collection's purpose, the Collection's likely burden on the affected public, an explanation of the necessity of the Collection, and other important information describing the Collection. There is one ICR for each Collection.

    The Coast Guard invites comments on whether this ICR should be granted based on the Collection being necessary for the proper performance of Departmental functions. In particular, the Coast Guard would appreciate comments addressing: (1) The practical utility of the Collection; (2) the accuracy of the estimated burden of the Collection; (3) ways to enhance the quality, utility, and clarity of information subject to the Collection; and (4) ways to minimize the burden of the Collection on respondents, including the use of automated collection techniques or other forms of information technology. In response to your comments, we may revise this ICR or decide not to seek an extension of approval for the Collection. We will consider all comments and material received during the comment period.

    We encourage you to respond to this request by submitting comments and related materials. Comments must contain the OMB Control Number of the ICR and the docket number of this request, [USCG-2017-0114], and must be received by October 6, 2017.

    Submitting Comments

    We encourage you to submit comments through the Federal eRulemaking Portal at http://www.regulations.gov. If your material cannot be submitted using http://www.regulations.gov, contact the person in the FOR FURTHER INFORMATION CONTACT section of this document for alternate instructions. Documents mentioned in this notice, and all public comments, are in our online docket at http://www.regulations.gov and can be viewed by following that Web site's instructions. Additionally, if you go to the online docket and sign up for email alerts, you will be notified when comments are posted.

    We accept anonymous comments. All comments received will be posted without change to http://www.regulations.gov and will include any personal information you have provided. For more about privacy and the docket, you may review a Privacy Act notice regarding the Federal Docket Management System in the March 24, 2005, issue of the Federal Register (70 FR 15086).

    Information Collection Request

    Title: Approval of Alterations to Marine Portable Tanks; Approval of Non-Specification Portable Tanks.

    OMB Control Number: 1625-0062.

    Summary: The information will be used to evaluate the safety of proposed alterations to marine portable tanks and non-specification portable tank designs used to transfer hazardous materials during offshore operations.

    Need: Approval by the Coast Guard of alterations to marine portable tanks under 46 CFR part 64 ensures that the altered tank retains the level of safety to which it was originally designed.

    Forms: Not applicable.

    Respondents: Owners of marine portable tanks and owners/designers of non-specification portable tanks.

    Frequency: On occasion.

    Hour Burden Estimate: The estimated annual burden remains 18 hours a year.

    Authority:

    The Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended.

    Dated: August 1, 2017. Marilyn L. Scott-Perez, U.S. Coast Guard, Chief, Office of Information Management.
    [FR Doc. 2017-16503 Filed 8-4-17; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard [Docket No. USCG-2016-0938] Collection of Information Under Review by Office of Management and Budget; OMB Control Number: 1625-0074 AGENCY:

    Coast Guard, DHS.

    ACTION:

    Thirty-day notice requesting comments.

    SUMMARY:

    In compliance with the Paperwork Reduction Act of 1995 the U.S. Coast Guard is forwarding an Information Collection Request (ICR), abstracted below, to the Office of Management and Budget (OMB), Office of Information and Regulatory Affairs (OIRA), requesting approval for reinstatement, without change, of the following collection of information: 1625-0074, Direct User Fees for Inspection or Examination of U.S. and Foreign Commercial Vessels. Our ICR describes the information we seek to collect from the public. Review and comments by OIRA ensure we only impose paperwork burdens commensurate with our performance of duties.

    DATES:

    Comments must reach the Coast Guard and OIRA on or before September 6, 2017

    ADDRESSES:

    You may submit comments identified by Coast Guard docket number [USCG-2016-0938] to the Coast Guard using the Federal eRulemaking Portal at http://www.regulations.gov. Alternatively, you may submit comments to OIRA using one of the following means:

    (1) Email: [email protected]

    (2) Mail: OIRA, 725 17th Street NW., Washington, DC 20503, attention Desk Officer for the Coast Guard.

    A copy of the ICR is available through the docket on the Internet at http://www.regulations.gov. Additionally, copies are available from: Commandant (CG-612), Attn: Paperwork Reduction Act Manager, U.S. Coast Guard, 2703 Martin Luther King Jr. Ave. SE., STOP 7710, Washington, DC 20593-7710.

    FOR FURTHER INFORMATION CONTACT:

    Mr. Anthony Smith, Office of Information Management, telephone 202-475-3532, or fax 202-372-8405, for questions on these documents.

    SUPPLEMENTARY INFORMATION: Public Participation and Request for Comments

    This Notice relies on the authority of the Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to OIRA seeking the approval, extension, or renewal of a Coast Guard collection of information (Collection). The ICR contains information describing the Collection's purpose, the Collection's likely burden on the affected public, an explanation of the necessity of the Collection, and other important information describing the Collection. There is one ICR for each Collection. The Coast Guard invites comments on whether this ICR should be granted based on the Collection being necessary for the proper performance of Departmental functions. In particular, the Coast Guard would appreciate comments addressing: (1) The practical utility of the Collection; (2) the accuracy of the estimated burden of the Collection; (3) ways to enhance the quality, utility, and clarity of information subject to the Collection; and (4) ways to minimize the burden of the Collection on respondents, including the use of automated collection techniques or other forms of information technology. These comments will help OIRA determine whether to approve the ICR referred to in this Notice.

    We encourage you to respond to this request by submitting comments and related materials. Comments to Coast Guard or OIRA must contain the OMB Control Number of the ICR. They must also contain the docket number of this request, [USCG-2016-0938], and must be received by September 5, 2017.

    Submitting Comments

    We encourage you to submit comments through the Federal eRulemaking Portal at http://www.regulations.gov. If your material cannot be submitted using http://www.regulations.gov, contact the person in the FOR FURTHER INFORMATION CONTACT section of this document for alternate instructions. Documents mentioned in this notice, and all public comments, are in our online docket at http://www.regulations.gov and can be viewed by following that Web site's instructions. Additionally, if you go to the online docket and sign up for email alerts, you will be notified when comments are posted.

    We accept anonymous comments. All comments received will be posted without change to http://www.regulations.gov and will include any personal information you have provided. For more about privacy and the docket, you may review a Privacy Act notice regarding the Federal Docket Management System in the March 24, 2005, issue of the Federal Register (70 FR 15086).

    OIRA posts its decisions on ICRs online at http://www.reginfo.gov/public/do/PRAMain after the comment period for each ICR. An OMB Notice of Action on each ICR will become available via a hyperlink in the OMB Control Number: 1625-0074.

    Previous Request for Comments

    This request provides a 30-day comment period required by OIRA. The Coast Guard has published the 60-day notice (81 FR 95155, December 27, 2016) required by 44 U.S.C. 3506(c)(2). That Notice elicited no comments. Accordingly, no changes have been made to the Collections.

    Information Collection Request

    Title: Direct User Fees for Inspection or Examination of U.S. and Foreign Commercial Vessels.

    OMB Control Number: 1625-0074.

    Summary: This collection requires the submission of identifying information such as a vessel's name and identification number, and of the owner's choice whether or not to pay fees for future years. A written request to the Coast Guard is necessary.

    Need: The Omnibus Budget Reconciliation Act of 1990 [Pub. L. 101-508], which amended 46 U.S.C. 2110, requires the Coast Guard to collect user fees from inspected vessels. To properly collect and mange these fees, the Coast Guard must have current information on identification. This collection helps to ensure that we get that information and manage it efficiently.

    Forms: None.

    Respondents: Owners of vessels.

    Frequency: Annually.

    Hour Burden Estimate: The estimated burden has increased from 2,783 hours to 2,999 hours a year due to an increase in the estimated annual number of responses.

    Authority: The Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended.

    Dated: August 1, 2017. Marilyn L. Scott-Perez, U.S. Coast Guard, Chief, Office of Information Management.
    [FR Doc. 2017-16504 Filed 8-4-17; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard [Docket No. USCG-2017-0124] Information Collection Request to Office of Management and Budget; OMB Control Number: 1625-0057 AGENCY:

    Coast Guard, DHS.

    ACTION:

    Sixty-day notice requesting comments.

    SUMMARY:

    In compliance with the Paperwork Reduction Act of 1995, the U.S. Coast Guard intends to submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB), Office of Information and Regulatory Affairs (OIRA), requesting a Reinstatement, without change, of a previously approved collection for which approval has expired for the following collection of information: 1625-0057, Small Passenger Vessels—Title 46 Subchapters K and T without change. Our ICR describes the information we seek to collect from the public. Before submitting this ICR to OIRA, the Coast Guard is inviting comments as described below.

    DATES:

    Comments must reach the Coast Guard on or before October 6, 2017.

    ADDRESSES:

    You may submit comments identified by Coast Guard docket number [USCG-2017-0124] to the Coast Guard using the Federal eRulemaking Portal at http://www.regulations.gov. See the “Public participation and request for comments” portion of the SUPPLEMENTARY INFORMATION section for further instructions on submitting comments.

    A copy of the ICR is available through the docket on the Internet at http://www.regulations.gov. Additionally, copies are available from: Commandant (CG-612), Attn: Paperwork Reduction Act Manager, U.S. Coast Guard, 2703 Martin Luther King Jr. Ave. SE., Stop 7710, Washington, DC 20593-7710.

    FOR FURTHER INFORMATION CONTACT:

    Contact Mr. Anthony Smith, Office of Information Management, telephone 202-475-3532, or fax 202-372-8405, for questions on these documents.

    SUPPLEMENTARY INFORMATION:

    Public Participation and Request for Comments

    This Notice relies on the authority of the Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to OIRA seeking the approval, extension, or renewal of a Coast Guard collection of information (Collection). The ICR contains information describing the Collection's purpose, the Collection's likely burden on the affected public, an explanation of the necessity of the Collection, and other important information describing the Collection. There is one ICR for each Collection.

    The Coast Guard invites comments on whether this ICR should be granted based on the Collection being necessary for the proper performance of Departmental functions. In particular, the Coast Guard would appreciate comments addressing: (1) The practical utility of the Collection; (2) the accuracy of the estimated burden of the Collection; (3) ways to enhance the quality, utility, and clarity of information subject to the Collection; and (4) ways to minimize the burden of the Collection on respondents, including the use of automated collection techniques or other forms of information technology. In response to your comments, we may revise this ICR or decide not to seek an extension of approval for the Collection. We will consider all comments and material received during the comment period.

    We encourage you to respond to this request by submitting comments and related materials. Comments must contain the OMB Control Number of the ICR and the docket number of this request, [USCG-2017-0124], and must be received by October 6, 2017.

    Submitting Comments

    We encourage you to submit comments through the Federal eRulemaking Portal at http://www.regulations.gov. If your material cannot be submitted using http://www.regulations.gov, contact the person in the FOR FURTHER INFORMATION CONTACT section of this document for alternate instructions. Documents mentioned in this notice, and all public comments, are in our online docket at http://www.regulations.gov and can be viewed by following that Web site's instructions. Additionally, if you go to the online docket and sign up for email alerts, you will be notified when comments are posted.

    We accept anonymous comments. All comments received will be posted without change to http://www.regulations.gov and will include any personal information you have provided. For more about privacy and the docket, you may review a Privacy Act notice regarding the Federal Docket Management System in the March 24, 2005, issue of the Federal Register (70 FR 15086).

    Information Collection Request

    Title: Small Passenger Vessels—Title 46 Subchapters K and T.

    OMB Control Number: 1625-0057.

    Summary: The information requirements are necessary for the proper administration and enforcement of the program on safety of commercial vessels as it affects small passenger vessels. The requirements affect small passenger vessels (under 100 gross tons) that carry more than 6 passengers.

    Need: Under the authority of 46 U.S.C. 3305 and 3306, the Coast Guard prescribed regulations for the design, construction, alteration, repair and operation of small passenger vessels to secure the safety of individuals and property on board. The Coast Guard uses the information in this collection to ensure compliance with the requirements.

    Forms: CG-841, Certificate of Inspection; CG-854, Temporary Certificate of Inspection; CG-948, Permit to Proceed to Another Port for Repairs; CG-949, Permit to Carry Excursion Party; CG-3752, Application for Inspection of U.S. Vessel; CG-5256, U.S. Coast Guard Inspected Small Passenger Vessel.

    Respondents: Owners and operators of small passenger vessels.

    Frequency: On occasion.

    Hour Burden Estimate: The estimated burden has decreased from 399,420 hours to 397,124 hours a year due to a decrease in the estimated annual number of respondents.

    Authority:

    The Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended.

    Dated: August 1, 2017. Marilyn L. Scott-Perez, U.S. Coast Guard, Chief, Office of Information Management.
    [FR Doc. 2017-16505 Filed 8-4-17; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR-6039-N-01] Allocations, Common Application, Waivers, and Alternative Requirements for Community Development Block Grant Disaster Recovery Grantees AGENCY:

    Office of the Assistant Secretary for Community Planning and Development, HUD.

    ACTION:

    Notice.

    SUMMARY:

    This notice provides guidance on issues arising from Community Development Block Grant disaster recovery (CDBG-DR) funds. Specifically, this notice allocates additional funds for 2015 and 2016 disasters; establishes an allocation framework for disasters that occur in 2017 and later; provides waivers for previously funded National Disaster Resilience Competition grants and for grantees that received certain CDBG-DR funding; provides a waiver for Rebuild By Design activities; and establishes an alternative requirement that creates new national objective criteria for grantees undertaking CDBG-DR buyouts and housing incentives.

    DATES:

    This notice will apply on: August 14, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Stan Gimont, Director, Office of Block Grant Assistance, Department of Housing and Urban Development, 451 7th Street SW., Room 7286, Washington, DC 20410, telephone number (202) 708-3587. Persons with hearing or speech impairments may access this number via TTY by calling the Federal Relay Service at (800) 877-8339. Facsimile inquiries may be sent to Mr. Gimont at (202) 401-2044. (Except for the “800” number, these telephone numbers are not toll-free.) Email inquiries may be sent to [email protected]

    SUPPLEMENTARY INFORMATION: Table of Contents I. 2015 and 2016 Allocations A. Background B. Use of Funds C. Grant Amendment Process D. Applicable Rules, Statutes, Waivers, and Alternative Requirements E. Duration of Funding II. Waivers and Alternative Requirements for CDBG-DR Funds Appropriated by Public Law 114-223, 114-254 and 115-31 (Applicable only to the State of Louisiana) III. Allocation Framework for Disasters in 2017 or Later A. Background B. Use of Funds IV. Public Law 113-2 Waivers and Alternative Requirements A. Background B. Applicable Rules, Statutes, Waivers, and Alternative Requirements V. New LMI National Objective Criteria for Buyouts and Housing Incentives (Applicable to Multiple Appropriations) VI. Catalog of Federal Domestic Assistance VII. Finding of No Significant Impact Appendix A: Allocation Methodology I. 2015 and 2016 Allocations A. Background

    Since December 2015, four different public laws have been enacted that have provided CDBG-DR appropriations to address major declared disasters that occurred in 2015, 2016, 2017, and later. Table 1 lists these various public laws, the related Federal Register notices that govern the funds, grantees that have received allocations, and amounts provided to those grantees.

    EN07AU17.021

    Each of the public laws identified above provides CDBG-DR funds for necessary expenses for activities authorized under title I of the Housing and Community Development Act of 1974 (HCDA) related to disaster relief, long-term recovery, restoration of infrastructure and housing, and economic revitalization in the most impacted and distressed areas resulting from a qualifying major disaster declared by the President pursuant to the Robert T. Stafford Disaster Relief and Emergency Assistance Act of 1974 (Stafford Act) (42 U.S.C. 5121 et seq.).

    CDBG-DR grants under each appropriation are governed by one or more Federal Register notices that contain the requirements, applicable waivers, and alternative requirements that apply to the use of the funds. Congress requires that HUD publish waivers and alternative requirements in the Federal Register.

    This Federal Register notice sets out the requirements, waivers, and alternative requirements that govern the funds appropriated under Public Law 115-31. Throughout this notice, references to Federal Register notices will be to the date the notices were published as noted in Table 1.

    Under Public Law 115-31, Congress appropriated $400 million in CDBG-DR funding to address remaining unmet needs (as defined by HUD) arising from qualifying major disasters that occurred in 2015 and 2016, and for qualifying major disasters that occur in 2017 or later, until the funds are fully allocated. Congress required that HUD, in distributing the $400 million, use the allocation methodologies identified in June 17, 2016, and January 18, 2017, Federal Register notices for disasters occurring in 2015 and 2016, respectively.

    Table 1, under the column labeled Public Law 115-31, reflects the allocation of funds appropriated by that act for qualifying disasters in 2015 and 2016 (inclusive of the amounts announced on May 18, 2017). In HUD's June 17, 2016, Federal Register notice, HUD described the allocation and applicable waivers and alternative requirements, relevant statutory and regulatory requirements, grant award process, criteria for Action Plan approval, and eligible disaster recovery activities for the qualifying 2015 disasters. Grantees receiving an allocation of funds under this Federal Register notice for qualifying 2015 disasters are subject to the authority and conditions of Public Law 114-113 and the requirements, waivers, and alternative requirements provided in the June 17, 2016, notice.

    In HUD's November 21, 2016, and January 18, 2017, Federal Register notices, HUD described the allocation and applicable waivers and alternative requirements, relevant statutory and regulatory requirements, grant award process, criteria for Action Plan approval, and eligible disaster recovery activities for the qualifying 2016 disasters. Grantees receiving allocations of funds under these Federal Register notices for qualifying 2016 disasters are subject to the authority and conditions of Public Law 114-223 and 114-254 and the requirements, waivers and alternative requirements provided in the November 21, 2016, and January 18, 2017, Federal Register notices.

    HUD is allocating the funds for the 2015 and 2016 disasters based on updated data HUD received from the Federal Emergency Management Agency (FEMA), and the Small Business Administration (SBA). HUD's allocations match the difference between HUD's 100 percent estimate of the serious unmet needs for repair in most impacted counties after taking into consideration other resources, including insurance, FEMA, SBA and the amounts previously allocated. HUD's methodology for allocation as specified in the June 17, 2016, and January 18, 2017, notices does not include additional funds for resilience activities. Detailed explanations of HUD's allocation methodologies for qualifying disasters from 2015 and 2016, are provided at Appendix A in the June 17, 2016 notice and Appendix A of the January 18, 2017 notice, respectively.

    Table 2—Qualifying 2015 and 2016 Disasters and “Most Impacted and Distressed” Areas FEMA disaster No. Grantee Minimum amount that must be
  • expended for recovery in the
  • HUD-identified “most impacted and
  • distressed” areas
  • 2015 Disasters 4241 Lexington County (Urban County), SC Lexington County Urban County Jurisdiction ($5,038,000). 4241 Columbia, SC Columbia ($6,166,000). 4241 Richland County, SC Richland County Urban County Jurisdiction ($7,254,000). 4241 State of South Carolina Charleston, Dorchester, Florence, Georgetown and Clarendon Counties * ($23,896,800). 4223, 4245 Houston, TX City of Houston ($20,532,000). 4223, 4245 San Marcos, TX City of San Marcos ($8,714,000). 4223, 4245, 4272 State of Texas Harris, Hays, Hidalgo, and Travis Counties ($12,511,200). 2016 Disasters 4263, 4277 State of Louisiana East Baton Rouge, Livingston, Ascension, Tangipahoa, Ouachita, Lafayette, Lafayette, Vermilion, Acadia, Washington, and St. Tammany Parishes ($41,148,000). 4273 State of West Virginia Kanawha, Greenbrier, Clay, and Nicholas Counties ** ($36,476,000). 4266, 4269, 4272 State of Texas Harris, Newton, Montgomery, Fort Bend, and Brazoria Counties ($13,304,800). 4285 State of North Carolina Robeson, Cumberland, Edgecombe, and Wayne Counties ($30,380,800). 4286 State of South Carolina Marion and Horry Counties ($23,824,800). 4280, 4283 State of Florida St. Johns County ($47,468,000). * Based on data presented by the grantee, HUD has approved the addition of Clarendon County to the 2015 South Carolina “most impacted and distressed” areas. ** Based on data presented by the grantee, HUD has approved the addition of Clay and Nicholas Counties to the 2016 West Virginia “most impacted and distressed” areas.

    Use of funds for all grantees is limited to unmet recovery needs from the major disasters identified in Table 2. Table 2 shows the HUD-identified “most impacted and distressed” areas impacted by the identified disasters. At least 80 percent of the total funds provided to each grantee under this notice must address unmet needs within the HUD-identified “most impacted and distressed” areas, as identified in Table 2. Grantees may spend the remaining 20 percent in the HUD-identified areas or areas the grantee determines to be “most impacted and distressed.”

    B. Use of Funds

    Public Law 115-31 requires funds to be used only for specific disaster recovery related purposes. This allocation provides funds to 2015 and 2016 CDBG-DR grantees for authorized disaster recovery efforts. Grantees allocated funds under this notice for 2015 and 2016 disasters must submit a substantial Action Plan Amendment as outlined below.

    C. Grant Amendment Process

    To receive funds allocated by this notice, 2015 and 2016 grantees (listed in Table 1) must submit a substantial Action Plan Amendment to their approved Action Plan and meet the following requirements:

    • Grantee must consult with affected citizens, stakeholders, local governments and public housing authorities to determine updates to its needs assessment;

    • Grantee must amend its Action Plan to update its needs assessment, modify or create new activities, or reprogram funds. Each amendment must be highlighted, or otherwise identified within the context of the entire Action Plan. The beginning of every Action Plan Amendment must include a: (1) Section that identifies exactly what content is being added, deleted, or changed; (2) chart or table that clearly illustrates where funds are coming from and where they are moving to; and (3) a revised budget allocation table that reflects the entirety of all funds;

    • Grantee must publish a substantial amendment to its previously approved Action Plan for Disaster Recovery prominently (see section VI.A.4.a of the November 21, 2016, notice and section VI.A.3.a of the June 17, 2016, notice) on the grantee's official Web site for no less than 14 calendar days. The manner of publication must include prominent posting on the grantee's official Web site and must afford citizens, affected local governments, and other interested parties a reasonable opportunity to examine the amendment's contents and provide feedback;

    • Grantee must respond to public comment and submit its substantial Action Plan Amendment to HUD no later than 90 days after the effective date of this notice;

    • HUD will review the substantial Action Plan Amendment within 45 days from date of receipt and determine whether to approve the Amendment per criteria identified in this notice and all applicable prior notices;

    • HUD will send an Action Plan Amendment approval letter, revised grant conditions (may not be applicable to all grantees), and an amended unsigned grant agreement to the grantee. If the substantial Amendment is not approved, a letter will be sent identifying its deficiencies; the grantee must then re-submit the Amendment within 45 days of the notification letter;

    • Grantee must ensure that the HUD approved substantial Action Plan Amendment (and original Action Plan) is posted prominently on its official Web Site;

    • Grantee must enter the activities from its published Action Plan Amendment into the Disaster Recovery Grant Reporting (DRGR) system and submit the updated DRGR Action Plan to HUD within the system;

    • Grantee must sign and return the grant agreement to HUD;

    • HUD will sign the grant agreement and revise the grantee's line of credit amount;

    • Grantee may draw down funds from the line of credit after the Responsible Entity completes applicable environmental review(s) pursuant to 24 CFR part 58, or adopts another Federal agency's environmental review where authorized under provisions incorporated by reference in Public Law 115-31, and, as applicable, receives a response from HUD or the state that approves the grantee's Request for Release of Funds and certification;

    • Grantee must amend its published Action Plan to include its projection of expenditures and outcomes within 90 days of the Action Plan Amendment approval.

    D. Applicable Rules, Statutes, Waivers, and Alternative Requirements

    Awards under this notice will be subject to the waivers and alternative requirements provided in the notices governing the award of CDBG-DR funds for 2015 and 2016disasters, as identified in Table 1. These waivers and alternative requirements provide additional flexibility in program design and implementation to support full and swift recovery following the disasters, while also ensuring that statutory requirements are met. Grantees may request additional waivers and alternative requirements from the Department as needed to address specific needs related to their recovery activities. Waivers and alternative requirements are effective five days after they are published in the Federal Register.

    E. Duration of Funding

    Public Law 115-31 provides that these funds will remain available until expended. However, consistent with 31 U.S.C. 1555 and OMB Circular A-11, if the Secretary or the President determines that the purposes for which the appropriation has been made have been carried out and no disbursements have been made against the appropriation for two consecutive fiscal years, any remaining balance will be made unavailable for obligation or expenditure. Consistent with the June 17, 2016, November 21, 2016, and January 18, 2017 notices, the provisions at 24 CFR 570.494 and 24 CFR 570.902 regarding timely distribution of funds are waived and replaced with alternative requirements under this notice. Grantees must expend 100 percent of their allocation of CDBG-DR funds on eligible activities within 6 years of HUD's execution of the grant agreement.

    II. Waivers and Alternative Requirements for CDBG-DR Funds Appropriated by Public Law 114-223, 114-254 and 115-31 (Applicable Only to the State of Louisiana)

    This section of the notice provides a waiver for the state of Louisiana, which has received CDBG-DR allocations pursuant to Public Law 114-223, 114-254 and 115-31. The state of Louisiana was allocated $1,656,972,000 in CDBG-DR funds under Public Law 114-223 and 114-254 and HUD has approved the state's use of these CDBG-DR funds for three main recovery programs: Housing (86 percent), economic development (4 percent), and infrastructure (6 percent). These programs were developed to address the most urgent and significant unmet needs of those areas impacted by the eligible 2016 disasters. This notice allocates $51,435,000 to Louisiana pursuant to Public Law 115-31, bringing the total amount allocated to the state for 2016 disasters to $1,708,407,000.

    1. Waiver of the 70 percent overall benefit requirement (State of Louisiana only). The overall benefit requirement set by the HCDA requires that 70 percent of the aggregate of the grantee's CDBG program's funds be used to support activities benefitting low- and moderate-income persons. It can be difficult for grantees working in disaster recovery to meet the overall benefit test, because disasters do not always affect low- and moderate-income areas and, therefore, this requirement can in some cases limit grantees' ability to assist the most damaged areas.

    The November 21, 2016, notice maintained the 70 percent overall benefit requirement for all grantees receiving funds under these public laws, but provided the state of Louisiana and all other grantees with additional flexibility to request a lower overall benefit requirement. Specifically, that notice allows a grantee to request to further reduce its overall benefit requirement if it submitted a justification that, at a minimum: (a) Identifies the planned activities that meet the needs of its low- and moderate-income population; (b) describes proposed activity(ies) and/or program(s) that will be affected by the alternative requirement, including their proposed location(s) and role(s) in the grantee's long-term disaster recovery plan; (c) describes how the activities/programs identified in (b) prevent the grantee from meeting the 70 percent requirement; and (d) demonstrates that low- and moderate-income (LMI) persons' disaster-related needs have been sufficiently met and that the needs of non-LMI persons or areas are disproportionately greater, and that the jurisdiction lacks other resources to serve them.

    The state of Louisiana submitted a request to establish a lower overall benefit requirement based on the above criteria. In its request, the state contends that out of the 57,600 households that suffered major or severe damage during the flooding in 2016, only 44 percent were low-and and moderate-income (LMI) persons. The State's request notes that due to the persistent flooding that occurs in these communities, offering assistance to all households in the areas affected by the storm, and not just LMI households, will help the impacted neighborhoods with critical rebuilding needs.

    Accordingly, the state will target its CDBG-DR funds to households with major or severe damage that did not have flood insurance at the time of the storms (36,510 households). The state indicates that 53 percent of those households qualify as LMI, and that 65 percent of the funds for the state's homeowner program will benefit those LMI households. The state also estimates that 100 percent of its housing rental funds will benefit LMI households, and 50 percent of the funds allocated for infrastructure and economic development activities will also meet the LMI national objective. The state designed its program so that those in greatest need are provided with the greatest level of assistance, by covering 100 percent of unmet needs for households earning less than 120 percent of area median income (AMI) and covering 50 percent of unmet needs for households above 120 percent of AMI. This approach prioritizes the unmet needs of LMI households and encourages higher income households to leverage personal or private funds.

    To enable the state to undertake the activities it has deemed most critical for its recovery, and to ensure that LMI households are sufficiently served and/or assisted, HUD is granting a waiver and alternative requirement to reduce the overall benefit requirement from 70 percent to not less than 55 percent of the state's allocation of CDBG-DR funds. This means that the state must use at least 55 percent of its CDBG-DR allocations under Public Law 114-223, 114-254 and 115-31 to benefit LMI households (or not less than $939,623,850.00).

    Based on the analysis submitted by the state, the Secretary finds a compelling need for this reduction due to the circumstances outlined in the state's request. In particular, HUD notes that the areas most damaged by the storms have limited LMI populations; that all of the state's recovery programs will have some component that will specifically benefit LMI households; that the persistent nature of flooding has led the state to focus on the importance of rebuilding communities in a holistic manner; and that the state will prioritize the unmet needs of LMI households in its homeowner recovery programs. HUD does not see evidence that reduction to the 50 percent level sought by the state is necessary given its approved program design and early data with respect to its applicant pools. HUD, however, does advise the state to maintain its current program design and targeting strategy to ensure that projected LMI benefit levels are achieved and the state continues to demonstrate that low- and moderate-income persons' disaster-related needs have been sufficiently met.

    This is a limited waiver modifying 42 U.S.C. 5301(c), 42 U.S.C. 5304(b)(3)(A), 24 CFR 570.484, and 570.200(a)(3) only to the extent necessary to reduce the low- and moderate-income overall benefit requirement that the state of Louisiana must meet when carrying out activities identified in its approved action from 70 percent to not less than 55 percent of the state's allocations of CDBG-DR funds under Public Law 114-223, 114-254 and 115-31.

    2. Waiver of Section 414 of the Stafford Act, 42 U.S.C. 5181 (State of Louisiana only). The state of Louisiana has requested a waiver of section 414 of the Stafford Act, as amended, for rehabilitation or reconstruction activities. This notice grants the State's request and specifies alternative requirements.

    Section 414 of the Stafford Act (42 U.S.C. 5181) provides that “Notwithstanding any other provision of law, no person otherwise eligible for any kind of replacement housing payment under the Uniform Relocation Assistance and Real Property Acquisition Policies Act of 1970 (Pub. L. 91-646) [42 U.S.C. 4601 et seq.] [“URA”] shall be denied such eligibility as a result of his being unable, because of a major disaster as determined by the President, to meet the occupancy requirements set by [the URA]”. Accordingly, tenants displaced from their homes as a result of the identified disaster and who would have otherwise been displaced as a direct result of any acquisition, rehabilitation, or demolition, of real property for a federally assisted project or program may become eligible for a replacement housing payment notwithstanding their inability to meet occupancy requirements prescribed in the URA.

    Section 414 of the Stafford Act (including its implementing regulation at 49 CFR 24.403(d)(1)), is waived to the extent that it would apply to the CDBG-DR funded rehabilitation and reconstruction activities undertaken by the state of Louisiana, or its subrecipients, for its grants under Public Law 114-223, Public Law 114-254 and Public Law 115-31; provided that the activities were not planned, approved, or otherwise underway prior to the disaster.

    The Department has surveyed other federal agencies' interpretation and implementation of Section 414 and found varying views and strategies for long-term, post-disaster projects involving the acquisition, rehabilitation, or demolition of disaster-damaged housing. Under the CDBG-DR supplemental appropriations, the Secretary has the authority to waive or specify alternative requirements for any provision of any statute or regulation that the Secretary administers in connection with the obligation by the Secretary or the use by the recipient of these funds. The Department, in special cases, has previously granted a waiver and provided alternative requirements of Section 414 to CDBG-DR grantees, including the Gulf States impacted by disasters in 2005 and 2008 (see 72 FR 48804) and the 2011 floods in the city of Minot, North Dakota (see 79 FR 60490).

    The severe floods of 2016 damaged Louisiana's affordable rental housing stock. According to the State, approximately 28,470 rental units were damaged by the floods, resulting in lower vacancies, increased rental rates and further exacerbating the housing cost burden among low- and moderate-income renters. Many of the damaged rental housing units have since been vacated by tenants who have found permanent housing elsewhere.

    The state of Louisiana's CDBG-DR Action Plan for recovery from the 2016 floods identifies this rental housing need and contains several programs geared toward the repair and increase of the affordable rental housing stock by using CDBG-DR funds to reconstruct or rehabilitate rental units that were damaged by the floods and to create new rental housing by providing funding for multi-family developments.

    Existing CDBG-DR funding is only sufficient to bring less than six percent of disaster-impacted rental units into decent, safe, and sanitary condition. With a potential pool of 1,500 units eligible for rehabilitati