Federal Register Vol. 82, No.209,

Federal Register Volume 82, Issue 209 (October 31, 2017)

Page Range50305-50489
FR Document

82_FR_209
Current View
Page and SubjectPDF
82 FR 50307 - Temporary Certification for Certain Records Related to the Assassination of President John F. KennedyPDF
82 FR 50305 - Combatting the National Drug Demand and Opioid CrisisPDF
82 FR 50417 - EnPowered; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 AuthorizationPDF
82 FR 50446 - Sunshine Act MeetingsPDF
82 FR 50372 - Information Collection; Generic Clearance for the Collection of Qualitative Feedback on Agency Service DeliveryPDF
82 FR 50445 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Material Hoists, Personnel Hoists, and Elevators StandardPDF
82 FR 50481 - Agency Information Collection Activities; Renewal of an Approved Information Collection: Motor Carrier Records Change FormPDF
82 FR 50443 - Notice Pursuant to the National Cooperative Research and Production Act of 1993-IMS Global Learning Consortium, Inc.PDF
82 FR 50444 - Notice Pursuant to the National Cooperative Research and Production Act of 1993-Cable Television Laboratories, Inc.PDF
82 FR 50358 - Hours of Service of Drivers: Application for Exemption; National Pork Producers Council (NPPC)PDF
82 FR 50444 - Notice Pursuant to the National Cooperative Research and Production Act of 1993-3D PDF Consortium, Inc.PDF
82 FR 50443 - Notice Pursuant to the National Cooperative Research and Production Act of 1993-OpenDaylight Project, Inc.PDF
82 FR 50444 - Notice Pursuant to the National Cooperative Research and Production Act of 1993-National Fire Protection AssociationPDF
82 FR 50418 - Fast-41 Best Practices: Delegated State Permitting ProgramsPDF
82 FR 50418 - Adequacy Status of the Kenosha County, Wisconsin Area for Submitted 8-Hour Ozone Attainment Demonstration for Transportation Conformity PurposesPDF
82 FR 50418 - Notice of Proposed Administrative Settlement Pursuant to the Comprehensive Environmental Response, Compensation, and Liability ActPDF
82 FR 50348 - Hazardous Waste Management System; Identification and Listing of Hazardous WastePDF
82 FR 50425 - Formations of, Acquisitions by, and Mergers of Bank Holding CompaniesPDF
82 FR 50426 - Formations of, Acquisitions by, and Mergers of Savings and Loan Holding CompaniesPDF
82 FR 50440 - Notice of Proposed Filing of Plats of Survey, South DakotaPDF
82 FR 50441 - Notice of Filing of Plats of Survey, ColoradoPDF
82 FR 50477 - Request for Comments on Small Business Administration Draft FY 2018-2022 Strategic PlanPDF
82 FR 50438 - Notice of HUD-Held Multifamily Loan Sale (MLS 2018-1)PDF
82 FR 50373 - Notice of Public Meeting of the Ohio Advisory Committee To Discuss the Committee's Next Topic of Civil Rights Study: Educational Funding in OhioPDF
82 FR 50480 - Membership in the National Parks Overflights Advisory GroupPDF
82 FR 50460 - Fixed Income Market Structure Advisory CommitteePDF
82 FR 50428 - Request for Information on Effective, Large-Scale, Sustainable Approaches To Help People Quit Using Tobacco by Employing Evidence-Based Treatment OptionsPDF
82 FR 50427 - Notice of Availability of the Final Environmental Assessment and Finding of No Significant Impact for HHS/CDC Chamblee Campus 2025 Master Plan, Chamblee, GeorgiaPDF
82 FR 50322 - Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; Snapper-Grouper Fishery of the South Atlantic; 2017 Recreational Accountability Measure and Closure for Greater AmberjackPDF
82 FR 50484 - Notice of OFAC Sanctions ActionsPDF
82 FR 50429 - Final Immediately Dangerous to Life or Health (IDLH) Value ProfilesPDF
82 FR 50312 - Tribal Transportation Program; Delay of Compliance DatePDF
82 FR 50427 - Public Availability of General Services Administration Fiscal Year 2016 Service Contract InventoryPDF
82 FR 50309 - Order Establishing a New De Minimis Threshold Phase-In Termination DatePDF
82 FR 50431 - Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza PandemicPDF
82 FR 50460 - Submission for OMB Review; Comment RequestPDF
82 FR 50477 - Proposed Collection; Comment RequestPDF
82 FR 50485 - Notice of OFAC Sanctions Actions; Sanctions Actions Pursuant to Executive Order 13581PDF
82 FR 50317 - Safety Zone; Monongahela River, Monongahela, PAPDF
82 FR 50394 - Carbon and Alloy Steel Wire Rod From the United Kingdom: Preliminary Affirmative Determination of Sales at Less Than Fair Value, and Preliminary Affirmative Determination of Critical CircumstancesPDF
82 FR 50389 - Carbon and Alloy Steel Wire Rod From Spain: Preliminary Affirmative Determination of Sales at Less Than Fair Value and Preliminary Determination of Critical Circumstances, in PartPDF
82 FR 50383 - Carbon and Alloy Steel Wire Rod From the Republic of South Africa: Preliminary Affirmative Determination of Sales at Less Than Fair Value, Preliminary Affirmative Determination of Critical Circumstances, and Preliminary Determination of No ShipmentsPDF
82 FR 50375 - Carbon and Alloy Steel Wire Rod From Ukraine: Preliminary Affirmative Determination of Sales at Less Than Fair ValuePDF
82 FR 50377 - Carbon and Alloy Steel Wire Rod From Turkey: Preliminary Affirmative Determination of Sales at Less Than Fair Value, and Preliminary Negative Determination of Critical CircumstancesPDF
82 FR 50386 - Carbon and Alloy Steel Wire Rod From the Republic of Korea: Preliminary Affirmative Determination of Sales at Less Than Fair Value, and Preliminary Negative Determination of Critical CircumstancesPDF
82 FR 50381 - Carbon and Alloy Steel Wire Rod From Italy: Preliminary Affirmative Determination of Sales at Less Than Fair ValuePDF
82 FR 50413 - Revised Non-Foreign Overseas per Diem RatesPDF
82 FR 50388 - Polyethylene Terephthalate Resin From the Sultanate of Oman: Rescission of Antidumping Duty Administrative Review; 2015-2017PDF
82 FR 50396 - Brass Sheet and Strip From France, Germany, Italy, and Japan: Continuation of Antidumping Duty OrdersPDF
82 FR 50435 - Office of the Director, National Institutes of Health; Notice of MeetingPDF
82 FR 50436 - National Institute of Allergy and Infectious Diseases; Notice of Closed MeetingPDF
82 FR 50437 - Center for Scientific Review; Notice of Closed MeetingsPDF
82 FR 50435 - Center for Scientific Review; Notice of Closed MeetingsPDF
82 FR 50324 - Energy Conservation Program: Test Procedure for Distribution TransformersPDF
82 FR 50416 - Inland Waterways Users Board Meeting NoticePDF
82 FR 50482 - Hours of Service of Drivers: Application for Exemption; Hub Group Trucking Inc.PDF
82 FR 50483 - Notice of Submission of Proposed Information Collection to OMB Agency Request for Renewal of a Previously Approved Collection: On-Line Complaint Form for Service-Related Issues in Air TransportationPDF
82 FR 50324 - Food Labeling: Health Claims; Soy Protein and Coronary Heart DiseasePDF
82 FR 50423 - Open Commission Meeting, Tuesday, October 24, 2017PDF
82 FR 50421 - Information Collections Being Reviewed by the Federal Communications CommissionPDF
82 FR 50424 - Information Collection Being Reviewed by the Federal Communications Commission Under Delegated AuthorityPDF
82 FR 50420 - Information Collection Being Reviewed by the Federal Communications Commission Under Delegated AuthorityPDF
82 FR 50487 - Advisory Committee on Disability Compensation; Notice of MeetingPDF
82 FR 50413 - Submission for OMB Review; Comment RequestPDF
82 FR 50321 - Business Data Services in an Internet Protocol Environment; Technology Transitions; Special Access for Price Cap Local Exchange Carriers; AT&T Corporation Petition for RulemakingPDF
82 FR 50478 - Reporting and Recordkeeping Requirements Under OMB ReviewPDF
82 FR 50486 - Senior Executive Service; Legal Division Performance Review BoardPDF
82 FR 50315 - Safety Zone, Savannah River, Savannah, GAPDF
82 FR 50346 - eInduction Option, Seamless Acceptance Program, and Full-Service Automation Option, Verification StandardsPDF
82 FR 50477 - Reporting and Recordkeeping Requirements Under OMB ReviewPDF
82 FR 50433 - E9(R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials; International Council for Harmonisation; Draft Guidance for Industry; AvailabilityPDF
82 FR 50479 - Eighteenth Tactical Operations Committee (TOC) MeetingPDF
82 FR 50479 - Thirteenth RTCA SC-229 406 MHz ELT Joint Plenary With EUROCAE WG-98PDF
82 FR 50446 - Agency Information Collection Activities: Proposed Collection; Comment Request; Consumer Assistance CenterPDF
82 FR 50315 - Drawbridge Operation Regulation; China Basin, San Francisco, CAPDF
82 FR 50458 - Proposed Collection; Comment Request; 30-Day Notice for Generic Clearance for the Collection of Qualitative Feedback on Agency Service DeliveryPDF
82 FR 50441 - Certain Access Control Systems and Components Thereof Notice of Request for Statement on the Public InterestPDF
82 FR 50442 - Certain Composite Aerogel Insulation Materials and Methods for Manufacturing the Same; Notice of Request for Statements on the Public InterestPDF
82 FR 50374 - Notice of Petitions by Firms for Determination of Eligibility To Apply for Trade Adjustment AssistancePDF
82 FR 50379 - Biodiesel From Indonesia: Preliminary Affirmative Determination of Sales at Less Than Fair ValuePDF
82 FR 50391 - Biodiesel From Argentina: Preliminary Affirmative Determination of Sales at Less Than Fair Value, Preliminary Affirmative Determination of Critical Circumstances, in PartPDF
82 FR 50411 - Western Pacific Fishery Management Council; Public MeetingsPDF
82 FR 50459 - Product Change-Priority Mail Express, Priority Mail, and First-Class Package Service Negotiated Service AgreementPDF
82 FR 50459 - Product Change-Priority Mail Express Negotiated Service AgreementPDF
82 FR 50459 - Product Change-Priority Mail Negotiated Service AgreementPDF
82 FR 50459 - Product Change-Priority Mail and First-Class Package Service Negotiated Service AgreementPDF
82 FR 50412 - New England Fishery Management Council; Public MeetingPDF
82 FR 50397 - New England Fishery Management Council; Public MeetingPDF
82 FR 50412 - Mid-Atlantic Fishery Management Council (MAFMC); Public MeetingPDF
82 FR 50488 - Agency Information Collection Activity: Survey of Healthcare Experiences of Patients (SHEP)PDF
82 FR 50487 - Agency Information Collection Activity: Veterans' Health Benefits Handbook QuestionnairePDF
82 FR 50489 - Agency Information Collection Activity: Application for Cash Surrender or Policy LoanPDF
82 FR 50468 - Self-Regulatory Organizations; NASDAQ BX, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Relating to the Exchange's Name ChangePDF
82 FR 50472 - Self-Regulatory Organizations; Bats BZX Exchange, Inc.; Notice of Filing of Amendments No. 2 and No. 3, and Order Granting Accelerated Approval of a Proposed Rule Change, as Modified by Amendments No. 2 and No. 3, To List and Trade Shares of the Aptus Fortified Value ETF, a Series of ETF Series Solutions, Under Rule 14.11(c)PDF
82 FR 50461 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing of Proposed Rule Change To List and Trade Shares of the Hartford Schroders Tax-Aware Bond ETF Under NYSE Arca Rule 8.600-EPDF
82 FR 50475 - Self-Regulatory Organizations; NYSE American LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend NYSE American Equities Rules 7.31E To Establish a Minimum Dollar Threshold Into the Price Protection MechanismsPDF
82 FR 50469 - Self-Regulatory Organizations; Nasdaq ISE, LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend Rules for Excluding Days From the Exchange's ADV and Market Maker Plus Tier Calculations in the Schedule of FeesPDF
82 FR 50360 - Endangered and Threatened Wildlife and Plants; 12-Month Finding on a Petition to List the Western Glacier Stonefly as an Endangered or Threatened Species; Proposed Threatened Species Status for Meltwater Lednian Stonefly and Western Glacier StoneflyPDF
82 FR 50438 - Waterway Suitability Assessment for Operation of Liquefied Hazardous Gas Terminal; Port Arthur, TXPDF
82 FR 50319 - Supplemental Standards of Ethical ConductPDF
82 FR 50373 - Notice of Public Meeting of the New York Advisory Committee for Discussion and Approval of the Draft Report of Broken Windows PolicingPDF
82 FR 50444 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Extension of a Currently Approved Collection: International Terrorism Victim Expense Reimbursement Program ApplicationPDF
82 FR 50478 - Additional Designation of North Korean Entities Pursuant to E.O. 13382PDF
82 FR 50371 - Submission for OMB Review; Comment RequestPDF
82 FR 50366 - Fisheries Off West Coast States; Highly Migratory Fisheries; California Drift Gillnet Fishery; Implementation of a Federal Limited Entry Drift Gillnet PermitPDF
82 FR 50363 - Merchant Marine Act and Magnuson-Stevens Act Provisions; Fishing Vessel, Fishing Facility and Individual Fishing Quota and Harvesting Rights Lending Program RegulationsPDF
82 FR 50417 - Information Session; Implementation of the Water Infrastructure Finance and Innovation Act of 2014PDF
82 FR 50420 - Notice of a Public Meeting of the National Drinking Water Advisory CouncilPDF
82 FR 50426 - Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding CompanyPDF
82 FR 50426 - Formations of, Acquisitions by, and Mergers of Bank Holding CompaniesPDF
82 FR 50397 - Takes of Marine Mammals Incidental to Specified Activities; Taking Marine Mammals Incidental to the Biorka Island Dock Replacement ProjectPDF
82 FR 50435 - National Advisory Committee on Rural Health and Human ServicesPDF
82 FR 50429 - Packaging, Storage, and Disposal Options To Enhance Opioid Safety-Exploring the Path Forward; Public Workshop; Request for CommentsPDF
82 FR 50371 - Notice of Public Information Collection Requirements Submitted to OMB for ReviewPDF
82 FR 50313 - Global Terrorism Sanctions RegulationsPDF
82 FR 50447 - Electronic Loan, Deposit, and Investment Data CollectionPDF

Issue

82 209 Tuesday, October 31, 2017 Contents Agency Agency for International Development NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 50371 2017-23523 Agriculture Agriculture Department See

Forest Service

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 50371 2017-23572
Antitrust Division Antitrust Division NOTICES Changes under National Cooperative Research and Production Act: 3D PDF Consortium, Inc., 50444 2017-23689 Cable Television Laboratories, Inc., 50444 2017-23691 IMS Global Learning Consortium, Inc., 50443 2017-23692 National Fire Protection Association, 50444 2017-23687 OpenDaylight Project, Inc., 50443 2017-23688 Army Army Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 50413 2017-23623 Centers Disease Centers for Disease Control and Prevention NOTICES Environmental Assessments; Availability, etc.: HHS/CDC Chamblee Campus 2025 Master Plan, Chamblee, GA, 50427-50428 2017-23668 National Institute for Occupational Safety and Health; Immediately Dangerous to Life or Health Value Profiles: Acetonitrile, Chloroacetonitrile, Methacrylonitrile, and Nitrogen Dioxide, 50429 2017-23665 Requests for Information: Effective, Large-Scale, Sustainable Approaches to Help People Quit Using Tobacco by Employing Evidence-based Treatment Options, 50428-50429 2017-23669 Civil Rights Civil Rights Commission NOTICES Meetings: New York Advisory Committee, 50373 2017-23575 Ohio Advisory Committee, 50373-50374 2017-23676 Coast Guard Coast Guard RULES Drawbridge Operations: China Basin, San Francisco, CA, 50315 2017-23608 Safety Zones: Monongahela River, Monongahela, PA, 50317-50319 2017-23652 Savannah River, Savannah, GA, 50315-50317 2017-23616 NOTICES Waterway Suitability Assessments: Operation of Liquefied Hazardous Gas Terminal; Port Arthur, TX, 50438 2017-23578 Commerce Commerce Department See

Economic Development Administration

See

International Trade Administration

See

National Oceanic and Atmospheric Administration

Commodity Futures Commodity FNonutures Trading Commission RULES Establishing a New De Minimis Threshold Phase-In Termination Date, 50309-50311 2017-23660 Defense Department Defense Department See

Army Department

See

Engineers Corps

NOTICES Revised Non-Foreign Overseas Per Diem Rates, 50413-50416 2017-23644
Economic Development Economic Development Administration NOTICES Trade Adjustment Assistance; Petitions, 50374 2017-23603 Energy Department Energy Department See

Federal Energy Regulatory Commission

PROPOSED RULES Energy Conservation Program: Test Procedure for Distribution Transformers, 50324 2017-23635
Engineers Engineers Corps NOTICES Meetings: Inland Waterways Users Board; Correction, 50416-50417 2017-23633 Environmental Protection Environmental Protection Agency PROPOSED RULES Hazardous Waste Management System: Identification and Listing of Hazardous Waste, 50348-50358 2017-23683 NOTICES Adequacy Status: Kenosha County, Wisconsin Area for Submitted 8-Hour Ozone Attainment Demonstration for Transportation Conformity Purposes, 50418 2017-23685 Fast-41 Best Practices: Delegated State Permitting Programs, 50418-50420 2017-23686 Meetings: Information Session; Implementation of the Water Infrastructure Finance and Innovation Act of 2014, 50417-50418 2017-23567 National Drinking Water Advisory Council, 50420 2017-23566 Proposed Administrative Settlements under CERCLA, 50418 2017-23684 Federal Aviation Federal Aviation Administration NOTICES Meetings: Eighteenth Tactical Operations Committee Meeting, 50479 2017-23612 Thirteenth RTCA SC-229 406 MHz ELT Joint Plenary with EUROCAE WG-98, 50479-50480 2017-23611 Requests for Nominations: National Parks Overflights Advisory Group, 50480-50481 2017-23672 Federal Communications Federal Communications Commission RULES Business Data Services in an Internet Protocol Environment: Technology Transitions; Special Access for Price Cap Local Exchange Carriers; AT and T Corp. Petition for Rulemaking, 50321-50322 2017-23621 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 50420-50425 2017-23625 2017-23626 2017-23627 Meetings: Open Commission, 50423-50424 2017-23628 Federal Energy Federal Energy Regulatory Commission NOTICES Initial Market-Based Rate Filings Including Requests for Blanket Section 204 Authorizations: EnPowered, 50417 2017-23771 Federal Motor Federal Motor Carrier Safety Administration PROPOSED RULES Hours of Service of Drivers; Exemption Applications: National Pork Producers Council, 50358-50359 2017-23690 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 50481-50482 2017-23693 Hours of Service of Drivers; Exemption Applications: Hub Group Trucking Inc., 50482-50483 2017-23632 Federal Reserve Federal Reserve System NOTICES Change in Bank Control Notices: Acquisitions of Shares of a Bank or Bank Holding Company, 50426 2017-23565 Formations of, Acquisitions by, and Mergers of Bank Holding Companies, 50425-50426 2017-23564 2017-23682 Formations of, Acquisitions by, and Mergers of Savings and Loan Holding Companies, 50426-50427 2017-23681 Fish Fish and Wildlife Service PROPOSED RULES Endangered and Threatened Species: Status for Meltwater Lednian Stonefly and Western Glacier Stonefly, 50360-50363 2017-23579 Food and Drug Food and Drug Administration PROPOSED RULES Food Labeling: Health Claims; Soy Protein and Coronary Heart Disease, 50324-50346 2017-23629 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic, 50431-50433 2017-23659 Guidance: Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials; International Council for Harmonisation, 50433-50434 2017-23613 Meetings: Packaging, Storage, and Disposal Options to Enhance Opioid Safety--Exploring the Path Forward; Public Workshop, 50429-50431 2017-23535 Foreign Assets Foreign Assets Control Office RULES Global Terrorism Sanctions Regulations, 50313-50315 2017-23433 NOTICES Blocking or Unblocking of Persons and Properties, 50484-50486 2017-23653 2017-23666 Forest Forest Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery, 50372-50373 2017-23700 General Services General Services Administration NOTICES Service Contract Inventories; Availability: Fiscal Year 2016, 50427 2017-23662 Health and Human Health and Human Services Department See

Centers for Disease Control and Prevention

See

Food and Drug Administration

See

Health Resources and Services Administration

See

National Institutes of Health

Health Resources Health Resources and Services Administration NOTICES Charter Renewals: National Advisory Committee on Rural Health and Human Services, 50435 2017-23562 Homeland Homeland Security Department See

Coast Guard

Housing Housing and Urban Development Department NOTICES HUD-Held Multifamily Loan Sale, 50438-50440 2017-23677 Indian Affairs Indian Affairs Bureau RULES Tribal Transportation Program; Delay of Compliance Date, 50312-50313 2017-23663 Interior Interior Department See

Fish and Wildlife Service

See

Indian Affairs Bureau

See

Land Management Bureau

International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Brass Sheet and Strip from France, Germany, Italy, and Japan, 50396-50397 2017-23642 Polyethylene Terephthalate Resin from the Sultanate of Oman, 50388-50389 2017-23643 Determinations of Sales at Less Than Fair Value: Biodiesel from Argentina, 50391-50394 2017-23601 Biodiesel from Indonesia, 50379-50381 2017-23602 Carbon and Alloy Steel Wire Rod from Italy, 50381-50383 2017-23645 Carbon and Alloy Steel Wire Rod from Spain, 50389-50391 2017-23650 Carbon and Alloy Steel Wire Rod from the Republic of Korea, 50386-50388 2017-23646 Carbon and Alloy Steel Wire Rod from the Republic of South Africa, 50383-50386 2017-23649 Carbon and Alloy Steel Wire Rod from the United Kingdom, 50394-50396 2017-23651 Carbon and Alloy Steel Wire Rod from Turkey, 50377-50379 2017-23647 Carbon and Alloy Steel Wire Rod from Ukraine, 50375-50377 2017-23648 International Trade Com International Trade Commission NOTICES Investigations; Determinations, Modifications, and Rulings, etc.: Certain Access Control Systems and Components Thereof, 50441-50442 2017-23605 Certain Composite Aerogel Insulation Materials and Methods for Manufacturing the Same, 50442-50443 2017-23604 Justice Department Justice Department See

Antitrust Division

See

Victims of Crime Office

Labor Department Labor Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Material Hoists, Personnel Hoists, and Elevators Standard, 50445-50446 2017-23694 Land Land Management Bureau NOTICES Plats of Survey: Colorado, 50441 2017-23679 South Dakota, 50440 2017-23680 Morris K. Morris K. and Stewart L. Udall Foundation NOTICES Meetings; Sunshine Act, 50446 2017-23726 National Credit National Credit Union Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Consumer Assistance Center, 50446-50447 2017-23610 Requests for Information: Electronic Loan, Deposit, and Investment Data Collection, 50447-50458 2017-23219 National Endowment for the Arts National Endowment for the Arts NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery, 50458-50459 2017-23607 National Foundation National Foundation on the Arts and the Humanities See

National Endowment for the Arts

National Institute National Institutes of Health NOTICES Meetings: Center for Scientific Review, 50435-50438 2017-23637 2017-23638 2017-23639 National Institute of Allergy and Infectious Diseases, 50436 2017-23640 Office of AIDS Research Advisory Council, 50435 2017-23641 National Oceanic National Oceanic and Atmospheric Administration RULES Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic: Snapper-Grouper Fishery of South Atlantic; Greater Amberjack; Recreational Accountability Measure and Closure, 50322-50323 2017-23667 PROPOSED RULES Fisheries Off West Coast States: Highly Migratory Fisheries; California Drift Gillnet Fishery; Implementation of a Federal Limited Entry Drift Gillnet Permit, 50366-50370 2017-23571 Fishing Vessel, Fishing Facility and Individual Fishing Quota and Harvesting Rights Lending Program Regulations, 50363-50366 2017-23570 NOTICES Meetings: Mid-Atlantic Fishery Management Council, 50412 2017-23591 New England Fishery Management Council, 50397, 50412-50413 2017-23592 2017-23593 Western Pacific Fishery Management Council, 50411-50412 2017-23600 Takes of Marine Mammals: Incidental to the Biorka Island Dock Replacement Project, 50397-50411 2017-23563 Postal Regulatory Postal Regulatory Commission RULES Supplemental Standards of Ethical Conduct, 50319-50321 2017-23576 Postal Service Postal Service PROPOSED RULES eInduction Option, Seamless Acceptance Program, and Full-Service Automation Option, Verification Standards, 50346-50348 2017-23615 NOTICES Product Changes: Priority Mail and First-Class Package Service Negotiated Service Agreement, 50459 2017-23594 Priority Mail Express Negotiated Service Agreement, 50459-50460 2017-23596 Priority Mail Express, Priority Mail, & First-Class Package Service Negotiated Service Agreement, 50459 2017-23597 Priority Mail Negotiated Service Agreement, 50459 2017-23595 Presidential Documents Presidential Documents ADMINISTRATIVE ORDERS Drug Abuse and Trafficking: Drug Demand and Opioid Crisis, National; Implementing Policy to Combat (Memorandum of October 26, 2017), 50305-50306 2017-23787 John F. Kennedy, Assassination of; Temporary Certification of Certain Related Records (Memorandum of October 26, 2017), 50307-50308 2017-23795 Securities Securities and Exchange Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 50460-50461, 50477 2017-23658 2017-23657 Charter Establishments: Fixed Income Market Structure Advisory Committee, 50460 2017-23670 Self-Regulatory Organizations; Proposed Rule Changes: Bats BZX Exchange, Inc., 50472-50475 2017-23583 NASDAQ BX, Inc., 50468-50469 2017-23584 Nasdaq ISE, LLC, 50469-50472 2017-23580 NYSE American, LLC, 50475-50476 2017-23581 NYSE Arca, Inc., 50461-50468 2017-23582 Small Business Small Business Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 50477-50478 2017-23614 2017-23620 Draft FY 2018-2022 Strategic Plan, 50477 2017-23678 State Department State Department NOTICES Blocking or Unblocking of Persons and Properties, 50478-50479 2017-23573 Transportation Department Transportation Department See

Federal Aviation Administration

See

Federal Motor Carrier Safety Administration

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: On-Line Complaint Form for Service-Related Issues in Air Transportation, 50483-50484 2017-23631
Treasury Treasury Department See

Foreign Assets Control Office

NOTICES Senior Executive Service: Legal Division Performance Review Board, 50486-50487 2017-23618
Veteran Affairs Veterans Affairs Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Application for Cash Surrender or Policy Loan, 50489 2017-23585 Survey of Healthcare Experiences of Patients, 50488 2017-23587 Veterans' Health Benefits Handbook Questionnaire, 50487 2017-23586 Meetings: Advisory Committee on Disability Compensation, 50487-50488 2017-23624 Victims Victims of Crime Office NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: International Terrorism Victim Expense Reimbursement Program Application, 50444-50445 2017-23574 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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82 209 Tuesday, October 31, 2017 Rules and Regulations COMMODITY FUTURES TRADING COMMISSION 17 CFR Part 1 Order Establishing a New De Minimis Threshold Phase-In Termination Date AGENCY:

Commodity Futures Trading Commission.

ACTION:

Order.

SUMMARY:

The Commodity Futures Trading Commission (“Commission” or “CFTC”) is issuing an order (“Order”), pursuant to the Commission regulation establishing the de minimis exception to the swap dealer definition, to establish December 31, 2019 as the new de minimis threshold phase-in termination date.

DATES:

Issued by the Commission on October 26, 2017.

FOR FURTHER INFORMATION CONTACT:

Matthew Kulkin, Director, 202-418-5213, [email protected]; Erik Remmler, Deputy Director, 202-418-7630, [email protected]; or Rajal Patel, Associate Director, 202-418-5261, [email protected], Division of Swap Dealer and Intermediary Oversight, Commodity Futures Trading Commission, Three Lafayette Centre, 1155 21st Street NW., Washington, DC 20581.

SUPPLEMENTARY INFORMATION:

I. Background

The Dodd-Frank Wall Street Reform and Consumer Protection Act (“Dodd-Frank Act”) 1 directed the CFTC and the U.S. Securities and Exchange Commission to jointly further define the term “swap dealer” and to include therein a de minimis exception.2 The CFTC's further definition of swap dealer is provided in § 1.3(ggg).3 The de minimis exception therein provides that a person shall not be deemed to be a swap dealer unless its swap dealing activity exceeds an aggregate gross notional amount threshold of $3 billion (measured over the prior 12-month period), subject to a phase-in period during which the gross notional amount threshold is set at $8 billion.4 Absent further action by the Commission, the phase-in period is scheduled to terminate on December 31, 2018, at which time the de minimis threshold would decrease to $3 billion.5

1 Public Law 111-203, 124 Stat. 1376 (2010). The text of the Dodd-Frank Act can be accessed on the Commission's Web site, at www.cftc.gov.

2See Dodd-Frank Act, sections 712(d) and 721. The definition of “swap dealer” can be found in section 1a(49) of the Commodity Exchange Act and as further defined in § 1.3(ggg). 7 U.S.C. 1a(49) and 17 CFR 1.3(ggg). The Commodity Exchange Act is at 7 U.S.C. 1, et seq. (2014), and is accessible on the Commission's Web site at www.cftc.gov.

3 17 CFR 1.3(ggg).

4See 17 CFR 1.3(ggg)(4). See also Further Definition of “Swap Dealer,” “Security-Based Swap Dealer,” “Major Swap Participant,” “Major Security-Based Swap Participant” and “Eligible Contract Participant”, 77 FR 30596 (May 23, 2012). This Order does not impact the de minimis threshold for swaps with “special entities” as defined in the Commodity Exchange Act, section 4s(h)(2)(C). 7 U.S.C. 6s(h)(2)(C).

5 Order Establishing De Minimis Threshold Phase-In Termination Date, 81 FR 71605, 71607 (Oct. 18, 2016).

When § 1.3(ggg) was adopted, establishing the $3 billion de minimis exception, the Commission explained that there was little swap dealing data available that could be used to guide it in setting a threshold level. The Commission expected that the implementation of swap data reporting may enable reassessment of the de minimis exception.6 Accordingly, in § 1.3(ggg), the Commission directed CFTC staff to issue a report, after a specified period of time, on topics relating to the de minimis exception “as appropriate, based on the availability of data and information.” 7 Section 1.3(ggg) further provides that after giving due consideration to the report and any associated public comment, the Commission may by order establish a termination date for the phase-in period or propose through rulemaking modifications to the de minimis exception.8

6See 77 FR at 30634, 30640.

7See 17 CFR 1.3(ggg)(4)(ii)(B).

8See 17 CFR 1.3(ggg)(4)(ii)(C).

Staff issued for public comment the Swap Dealer De Minimis Exception Preliminary Report on November 18, 2015 (“Preliminary Report”).9 After consideration of the public comments received, and further data analysis, staff issued the Swap Dealer De Minimis Exception Final Staff Report 10 on August 15, 2016 (“Final Report,” and together with the Preliminary Report, the “Staff Reports”). The Staff Reports analyzed the available swap data in conjunction with relevant policy considerations to assess alternative de minimis threshold levels and other potential changes to the de minimis exception. The Staff Reports noted that the swap market data available, while much improved since § 1.3(ggg) was first adopted, was still somewhat limited in providing detailed information for assessing appropriate changes to the de minimis exception. For example, notional amounts could only be analyzed for the interest rate and credit default swap asset classes because, at the time, sufficient reliable notional data was not available for the other asset classes. As a further example, some of the data analyzed for the Staff Reports had significant quality issues. One of the “key issues” identified in the Final Report for Commission consideration was whether to delay reduction of the de minimis threshold to allow efforts to improve data quality to progress so that the Commission could better determine the appropriate de minimis threshold.11

9Available at http://www.cftc.gov/idc/groups/public/@swaps/documents/file/dfreport_sddeminis_1115.pdf.

10Available at http://www.cftc.gov/idc/groups/public/@swaps/documents/file/dfreport_sddeminis081516.pdf.

11 Final Report at 26.

In October 2016, the Commission issued an order, pursuant to § 1.3(ggg)(4)(ii)(C)(1), establishing December 31, 2018 as the de minimis threshold phase-in termination date, thereby extending the original phase-in period by one year (“October 2016 Order”).12 In the order, the Commission stated that the phase-in period extension provides additional time for further information to become available to more effectively reassess the de minimis exception.13 Given the twelve month lookback for calculating the swap dealing notional amount, a firm may need to start tracking its swap dealing activity on January 1, 2018 to determine whether its dealing activity would require it to register when the phase-in period ends on December 31, 2018.

12 81 FR 71605; 17 CFR 1.3(ggg)(4)(ii)(C)(1).

13 81 FR at 71607.

II. New Phase-In Termination Date

As contemplated by the October 2016 Order, significant strides are being made in updating, improving, and reassessing the available swap data regarding the swap marketplace in a more granular manner. Though this data analysis is ongoing, the Commission believes that it will in the near future have more detailed data analysis to inform its consideration of possible modifications to the de minimis exception.14 However, any such modifications, if implemented, would not become effective until some point in 2018, when the Commission completes the proposal, public comment, and final rule amendment process pursuant to the Administrative Procedure Act.

14 The Commission also notes that the continuing efforts by the Division of Market Oversight to improve data quality have improved data analysis capabilities.

This timing creates some uncertainty for currently unregistered swap dealers that may be subject to registration if the $3 billion de minimis threshold goes into effect on December 31, 2018. Such entities will not know what de minimis exception changes, if any, may become effective. Given this uncertainty, firms that might be subject to registration if the de minimis threshold decreases to $3 billion would need to start managing, and perhaps altering, their swap dealing activity starting in January 2018 to remain below the $3 billion threshold by December 31, 2018. Further, some firms might begin analyzing and adjusting their dealing activities prior to January 2018 if they do not want to be subject to registration. Such changes in behavior could lead to reduced competition, liquidity, and efficiency in the swap market, which may cause disruptions for the firms and their swap counterparties that might be unnecessary depending on the outcome of the continuing assessment of the de minimis exception.

Additionally, the Commission notes that a year's delay would provide additional time for the new Commissioners 15 and the new Director of the Division of Swap Dealer and Intermediary Oversight, all of whom only joined the Commission in the last two months, to better familiarize themselves with the issues relevant to the de minimis exception and results of the swap data analysis currently underway.

15See Brian Quintenz Sworn In as a Commissioner of the U.S. Commodity Futures Trading Commission (Aug. 15, 2017), http://www.cftc.gov/PressRoom/PressReleases/pr7602-17; Rostin Behnam Sworn In as a Commissioner of the CFTC (Sep. 6, 2017), http://www.cftc.gov/PressRoom/PressReleases/pr7610-17. Additionally, there are currently two additional Commission vacancies that may be filled soon.

Accordingly, the Commission believes that it is prudent to extend the phase-in period by one year. This extension will provide additional time for Commission staff to conduct data analysis regarding the de minimis exception, give market participants further clarity regarding when they will need to begin preparing for a change, if any, to the de minimis exception, and provide additional time for new Commissioners and staff to become better apprised of issues relevant to this topic.

III. Conclusion and Order

For the reasons discussed above, and pursuant to its authority under § 1.3(ggg)(4)(ii)(C)(1), the Commission is establishing December 31, 2019 as the new termination date for the de minimis threshold phase-in period. The Commission notes that prior to the termination of the phase-in period, the Commission plans to take further action regarding the de minimis threshold.

IV. Related Matters A. Paperwork Reduction Act

The Paperwork Reduction Act (“PRA”) 16 imposes certain requirements on Federal agencies in connection with their conducting or sponsoring any collection of information as defined by the PRA. This Order does not impose any new recordkeeping or information collection requirements, or other collections of information that require approval of the Office of Management and Budget under the PRA.

16 44 U.S.C. 3501 et seq.

B. Cost-Benefit Considerations

Section 15(a) of the Commodity Exchange Act (“CEA”) requires the Commission to consider the costs and benefits of its actions before promulgating a regulation under the CEA or issuing certain orders.17 Section 15(a) further specifies that the costs and benefits shall be evaluated in light of five broad areas of market and public concern: (i) Protection of market participants and the public; (ii) efficiency, competitiveness, and financial integrity of futures markets; (iii) price discovery; (iv) sound risk management practices; and (v) other public interest considerations. In this section, the Commission considers the costs and benefits resulting from its determinations with respect to the Section 15(a) factors.

17 7 U.S.C. 19(a).

1. Background

As discussed above, § 1.3(ggg)(4)(i) provides an exception from the swap dealer definition for persons who engage in a de minimis amount of swap dealing activity. Currently, under § 1.3(ggg)(4)(i), a person shall not be deemed to be a swap dealer unless its swap dealing activity exceeds an aggregate gross notional amount threshold of $3 billion (measured over the prior 12-month period), subject to a phase-in period during which the gross notional amount threshold is set at $8 billion.18 The phase-in period would have terminated on December 31, 2018, and the de minimis threshold would have decreased to $3 billion, absent this Order.19 This would have required firms to start tracking their swap activity beginning January 1, 2018 to determine whether their dealing activity over the course of that year would require them to register as swap dealers.

18 17 CFR 1.3(ggg)(4)(i). See generally 77 FR at 30626-35. See also note 4, supra.

19See 81 FR 71605.

The $3 billion threshold, which, absent this Order, would be effective on December 31, 2018, sets the baseline for the Commission's consideration of the costs and benefits of this Order.20 Accordingly, the Commission considers the costs and benefits that will result from extending the phase-in period.

20See 77 FR at 30702-14 (discussing the cost-benefit considerations with regard to the final swap dealer definition); 81 FR at 71607.

2. General Cost and Benefit Considerations

There are several policy objectives underlying swap dealer regulation and the de minimis exception to the swap dealer definition. The primary policy objectives of swap dealer regulation include the reduction of systemic risk, increased counterparty protections, and market efficiency, orderliness, and transparency.21 Registered swap dealers are subject to a broad range of requirements, including, inter alia, registration, internal and external business conduct standards, reporting, recordkeeping, risk management, posting and collecting margin, and chief compliance officer designation and responsibilities. As noted in the § 1.3(ggg) adopting release, generally, the lower the de minimis threshold, the greater the number of entities that are subject to these requirements, which could decrease systemic risk, increase counterparty protections, and promote swap market efficiency, orderliness, and transparency.22

21 77 FR at 30628-30, 30707-08.

22Id. at 30628-30, 30703, 30707-08.

The Commission also considers policy objectives furthered by a de minimis exception, which include regulatory certainty, allowing limited ancillary dealing, encouraging new participants to enter the swap dealing market, and regulatory efficiency.23 Generally, the higher the de minimis threshold, the greater the number of entities that are able to engage in dealing activity without being required to register, which could increase competition and liquidity in the swap market.24 In addition, because competitive markets may be more efficient, a higher de minimis threshold might improve swap market efficiency. Further, the Commission notes that it has been suggested that a higher threshold could allow the Commission to expend its resources on entities with larger swap dealing activities warranting more oversight. An alternative view is that the de minimis threshold should be set based on policy independent of consideration of the Commission's resources.

23Id. at 30628-30, 30707-08.

24 Alternatively, the Commission notes that a lower de minimis threshold may lead to potential changes in market behavior, including, for example, product innovation.

Extending the phase-in period by one year will delay realization of the policy benefits associated with the $3 billion de minimis threshold, but will also extend the policy benefits associated with a higher de minimis threshold. The additional time to adjust to the $3 billion de minimis threshold also would potentially increase regulatory certainty for some market participants. Given that the de minimis exception is subject to a 12-month look-back, extending the phase-in period to December 31, 2019 would allow entities that would potentially have to register as swap dealers additional time to adjust their activities and prepare for the compliance obligations related to swap dealer registration.

3. Section 15(a)

Section 15(a) of the CEA requires the Commission to consider the effects of its actions in light of the following five factors. This Order will delay the potential costs and benefits discussed below by one year.

(i) Protection of Market Participants and the Public

Providing regulatory protections for swap counterparties who may be less experienced or knowledgeable about the swap products offered by swap dealers (particularly end-users who use swaps for hedging or investment purposes) is a fundamental policy goal advanced by the regulation of swap dealers. The Commission recognizes that the $3 billion de minimis threshold may result in more entities being required to register as swap dealers compared to an $8 billion threshold, thereby extending counterparty protections to a greater number of market participants. Further, swap dealer regulation is intended to reduce systemic risk in the swap market because registered swap dealers are subject to a broad range of requirements, including, inter alia, requirements applicable to internal and external business conduct standards, reporting and recordkeeping, risk management, posting and collecting margin, and chief compliance officer designation and responsibilities. Pursuant to the Dodd-Frank Act, the Commission has proposed or adopted regulations for swap dealers—including margin and risk management requirements—designed to mitigate the potential systemic risk inherent in the swap market. Therefore, the Commission recognizes that a lower de minimis threshold may result in more entities being required to register as swap dealers, thereby potentially further reducing systemic risk.

(ii) Efficiency, Competitiveness, and Financial Integrity of Markets

Other goals of swap dealer regulation are swap market transparency, orderliness, and efficiency. These benefits are achieved through regulations requiring, for example, swap dealers to keep trading records and report trades, provide counterparty disclosures about swap risks and pricing, and undertake portfolio reconciliation and compression exercises. Accordingly, the Commission notes that a lower de minimis threshold may have a positive effect on the efficiency and integrity of the markets.

However, the Commission also recognizes that the efficiency and competitiveness of the swap market may be negatively impacted if the de minimis threshold is set too low by potentially increasing barriers to entry that may stifle competition and reduce swap market efficiency. For example, if entities choose to reduce or cease their swap dealing activities so that they would not need to register if the de minimis threshold decreases to $3 billion, the number or availability of market makers for swaps may be reduced, which could lead to increased costs for potential counterparties and end-users through having to pay higher spreads when undertaking swap transactions or foregoing the benefits of engaging in certain swap transactions that they would otherwise have undertaken.

(iii) Price Discovery

The Commission preliminarily believes that a $3 billion de minimis threshold may discourage participation of new swap dealers and ancillary dealing. If there are fewer entities engaged in dealing, there may be a negative effect on price discovery.

(iv) Sound Risk Management

The Commission notes that a $3 billion de minimis threshold could lead to better risk management practices because a greater number of entities would be required by regulation to: (i) Develop and implement detailed risk management programs; (ii) adhere to business conduct standards that reduce operational and other risks; and (iii) satisfy margin requirements for uncleared swaps.

(v) Other Public Interest Considerations

The Commission has not identified any other public purpose considerations for this Order.

C. Antitrust Considerations

Section 15(b) of the CEA requires the Commission to take into consideration the public interest to be protected by the antitrust laws and endeavor to take the least anticompetitive means of achieving the objectives of the CEA, in issuing any order or adopting any Commission rule or regulation. The Commission does not anticipate that the Order discussed herein will result in anti-competitive behavior.

V. Order

In light of the foregoing, it is ordered, pursuant to the Commission's authority under § 1.3(ggg)(4)(ii)(C)(1), that the de minimis threshold phase-in termination date shall be December 31, 2019.

The Commission retains the authority to condition further, modify, suspend, terminate, or otherwise restrict any of the terms of the Order provided herein, in its discretion.

Issued in Washington, DC, on October 26, 2017, by the Commission. Christopher J. Kirkpatrick, Secretary of the Commission. Appendix to Order Establishing a New De Minimis Threshold Phase-In Termination Date—Commission Voting Summary

On this matter, Chairman Giancarlo and Commissioner Quintenz voted in the affirmative. Commissioner Behnam voted in the negative.

[FR Doc. 2017-23660 Filed 10-30-17; 8:45 am] BILLING CODE 6351-01-P
DEPARTMENT OF THE INTERIOR Bureau of Indian Affairs 25 CFR Part 170 [178A2100DD/AAKC001030/A0A501010.999900 253G] RIN 1076-AF38 Tribal Transportation Program; Delay of Compliance Date AGENCY:

Bureau of Indian Affairs, Interior.

ACTION:

Interim final rule.

SUMMARY:

This interim final rule updates the Tribal Transportation Program regulations published in 2016 to delay the deadline for Tribes to comply with requirements to collect data on proposed roads for the National Tribal Transportation Facility Inventory (NTTFI).

DATES:

This rule is effective October 31, 2017. Submit comments by November 30, 2017. Compliance with § 170.443 for proposed roads currently in the NTTFI to remain in the inventory is required by November 7, 2019.

ADDRESSES:

You may submit comments by either: (1) Federal rulemaking portal www.regulations.gov (the rule is listed under the agency name “Bureau of Indian Affairs”); or (2) Mail, Hand Delivery, or Courier to: Ms. Elizabeth Appel, Office of Regulatory Affairs & Collaborative Action, U.S. Department of the Interior, 1849 C Street NW., Mail Stop 4660, Washington, DC 20240. We cannot ensure that comments received after the close of the comment period (see DATES) will be included in the docket for this rulemaking and considered. Comments sent to an address other than those listed above will not be included in the docket.

FOR FURTHER INFORMATION CONTACT:

Mr. LeRoy Gishi, Division of Transportation, Office of Indian Services, Bureau of Indian Affairs, (202) 513-7711, [email protected]

SUPPLEMENTARY INFORMATION:

I. Summary of Rule

Regulations governing the Tribal Transportation Program published last year. See 81 FR 78456 (November 7, 2016). The regulations became effective on December 7, 2016, except for § 170.443, which required Tribes' compliance one year later: on November 7, 2017. Section 170.443 requires Tribes to collect data for proposed roads to be added to, or remain in, the NTTFI. This interim final rule affects only § 170.443. The rule delays the current November 7, 2017, deadline for compliance with that section to November 7, 2019. This delay will allow the Bureau of Indian Affairs time to reexamine the need for this data collected in the NTTFI and consult with Tribes on whether revision or deletion of the data collection requirements in § 170.443 is appropriate. The Bureau of Indian Affairs finds that there is good cause to place this rule into immediate effect before receiving public comment and without a 30-day waiting period because the delay in the compliance deadline is expected to be uncontroversial with both the impacted Tribes and the public, and placing into immediate effect will eliminate potentially needless expenditure of resources by Tribes.

II. Procedural Requirements A. Regulatory Planning and Review (E.O. 12866 and 13563)

Executive Order (E.O.) 12866 provides that the Office of Information and Regulatory Affairs (OIRA) at the Office of Management and Budget (OMB) will review all significant rules. OIRA has determined that this rule is not significant.

E.O. 13563 reaffirms the principles of E.O. 12866 while calling for improvements in the nation's regulatory system to promote predictability, to reduce uncertainty, and to use the best, most innovative, and least burdensome tools for achieving regulatory ends. The E.O. directs agencies to consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice for the public where these approaches are relevant, feasible, and consistent with regulatory objectives. E.O. 13563 emphasizes further that regulations must be based on the best available science and that the rulemaking process must allow for public participation and an open exchange of ideas. We have developed this rule in a manner consistent with these requirements.

B. Regulatory Flexibility Act

This rule will not have a significant economic effect on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) because Tribes are not small entities under the Regulatory Flexibility Act.

C. Small Business Regulatory Enforcement Fairness Act

This rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. This rule:

(a) Does not have an annual effect on the economy of $100 million or more because this rule affects only surface transportation for Tribes.

(b) Will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions because it does not affect costs or prices.

(c) Does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises because the rule addresses Tribal surface transportation within the United States.

D. Unfunded Mandates Reform Act

This rule does not impose an unfunded mandate on State, local, or Tribal governments or the private sector of more than $100 million per year. The rule does not have a significant or unique effect on State, local, or Tribal governments or the private sector. A statement containing the information required by the Unfunded Mandates Reform Act (2 U.S.C. 1531 et seq.) is not required.

E. Takings (E.O. 12630)

This rule does not affect a taking of private property or otherwise have taking implications under E.O. 12360. A takings implication assessment is not required.

F. Federalism (E.O. 13132)

Under the criteria in section 1 of E.O. 13132, this rule does not have sufficient Federalism implications to warrant the preparation of a summary impact statement, because the rule primarily addresses the relationship between the Federal Government and Tribes. A Federalism summary impact statement is not required.

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

This rule complies with the requirements of E.O. 12988. Specifically, this rule:

(a) Meets the criteria of section 3(a) requiring that all regulations be reviewed to eliminate errors and ambiguity and written to minimize litigation; and

(b) Meets the criteria of section 3(b)(2) requiring that all regulations be written in clear language and contain clear legal standards.

H. Consultation With Indian Tribes (E.O. 13175 and Departmental policy)

The Department of the Interior strives to strengthen its government-to-government regulations with Indian Tribes through a commitment to consultation with Indian Tribes and recognition of their right to self-governance and Tribal sovereignty. We have evaluated this rule under the Department's consultation policy and have identified substantial direct effects on federally recognized Indian Tribes that will result from this rule. This rule will relieve a regulatory burden from Tribes and allow time for consultation on an appropriate replacement or deletion of regulatory requirements.

I. Paperwork Reduction Act

This rule contains information collection requirements, and the Office of Management and Budget (OMB) has approved the information collections under the Paperwork Reduction Act (PRA) under OMB Control Number 1076-0161, which expires December 31, 2019. Please note that an agency may not sponsor or request, and an individual need not respond to, a collection of information unless it displays a valid OMB Control Number.

J. National Environmental Policy Act

This rulemaking does not constitute a major Federal action significantly affecting the quality of the human environment because it is of an administrative, technical, and procedural nature. It is therefore subject to categorical exclusion, see 43 CFR 46.210(i), and no extraordinary circumstances exist, see 43 CFR 46.215.

K. Effects on the Energy Supply (E.O. 13211)

This rulemaking is not a significant energy action under the definition in E.O. 13211. A Statement of Energy Effects is not required.

L. Clarity of This Regulation

We are required by Executive Orders 12866 (section 1(b)(12)), and 12988 (section 3(b)(1)(B)), and 13563 (section 1(a)), and by the Presidential Memorandum of June 1, 1998, to write all rules in plain language. This means that each rule we publish must:

(a) Be logically organized;

(b) Use the active voice to address readers directly;

(c) Use common, everyday words and clear language rather than jargon;

(d) Be divided into short sections and sentences; and

(e) Use lists and tables wherever possible.

If you feel that we have not met these requirements, send us comments by one of the methods listed in the ADDRESSES section. To better help us revise the rule, your comments should be as specific as possible. For example, you should tell us the numbers of the sections or paragraphs that you find unclear, which sections or sentences are too long, the sections where you think lists or tables would be useful, etc.

M. E.O. 13771: Reducing Regulation and Controlling Regulatory Costs

This rule is not an E.O. 13771 regulatory action because this rule is not significant under E.O. 12866.

List of Subjects in 25 CFR Part 170

Highways and roads, Indians—lands.

For the reasons stated in the preamble, the Department of the Interior, Bureau of Indian Affairs, amends part 170 in Title 25 of the Code of Federal Regulations as follows:

PART 170—TRIBAL TRANSPORATION PROGRAM 1. The authority citation for part 170 continues to read as follows: Authority:

Pub. L. 112-141, Pub. L. 114-94; 5 U.S.C. 2; 23 U.S.C. 201, 202; 25 U.S.C. 2, 9.

2. In § 170.443, revise paragraph (b) to read as follows:
§ 170.443 What is required to successfully include a proposed transportation facility in the NTTFI?

(b) For those proposed roads that currently exist in the NTTFI, the requirements identified above as paragraphs (a)(1) through (a)(8) of this section, must be completed and submitted for approval to BIA and FHWA by November 7, 2019, in order to remain on the inventory.

Dated: October 6, 2017. John Tahsuda, Acting Assistant Secretary—Indian Affairs.
[FR Doc. 2017-23663 Filed 10-30-17; 8:45 am] BILLING CODE 4337-15-P
DEPARTMENT OF THE TREASURY Office of Foreign Assets Control 31 CFR Part 594 Global Terrorism Sanctions Regulations AGENCY:

Office of Foreign Assets Control, Treasury.

ACTION:

Final rule.

SUMMARY:

The Department of the Treasury's Office of Foreign Assets Control (OFAC) is amending the Global Terrorism Sanctions Regulations pursuant to a provision of the Countering America's Adversaries Through Sanctions Act of 2017. This provision requires the imposition of certain terrorism-related sanctions with respect to foreign persons that are officials, agents, or affiliates of Iran's Islamic Revolutionary Guard Corps.

DATES:

Effective: October 31, 2017.

FOR FURTHER INFORMATION CONTACT:

The Department of the Treasury's Office of Foreign Assets Control: Assistant Director for Licensing, tel.: 202-622-2480, Assistant Director for Regulatory Affairs, tel.: 202-622-4855, Assistant Director for Sanctions Compliance & Evaluation, tel.: 202-622-2490; or the Department of the Treasury's Office of the Chief Counsel (Foreign Assets Control), Office of the General Counsel, tel.: 202-622-2410.

SUPPLEMENTARY INFORMATION: Electronic Availability

This document and additional information concerning OFAC are available from OFAC's Web site (www.treasury.gov/ofac).

Background

On June 6, 2003, OFAC issued the Global Terrorism Sanctions Regulations, 31 CFR part 594 (the “Regulations”) (68 FR 34196, June 6, 2003), to implement Executive Order 13224 of September 23, 2001 (66 FR 49079, September 25, 2001) (E.O. 13224). OFAC has amended the Regulations on several occasions. Today, OFAC is amending the Regulations pursuant to section 105 of the Countering America's Adversaries Through Sanctions Act of 2017, Public Law 115-44, Aug. 2, 2017, 131 Stat. 886 (22 U.S.C. 9401 et seq.) (CAATSA).

CAATSA. The President signed CAATSA into law on August 2, 2017. Section 105 of CAATSA requires the President to impose the sanctions applicable with respect to a foreign person pursuant to E.O. 13224 on Iran's Islamic Revolutionary Guard Corps (IRGC) and foreign persons that are officials, agents, or affiliates of the IRGC. Such sanctions must be imposed beginning on the date that is 90 days after enactment of CAATSA, which is October 31, 2017. Section 111(b) of CAATSA provides that the President may exercise all authorities provided under sections 203 and 205 of the International Emergency Economic Powers Act (50 U.S.C. 1702 and 1704) to carry out the purposes of CAATSA.

Pursuant to Presidential Memorandum of October 11, 2017: Delegation of Certain Functions and Authorities under the Countering America's Adversaries Through Sanctions Act of 2017, the President delegated to the Secretary of State and the Secretary of the Treasury the functions and authorities vested in the President by section 105(b) of CAATSA to be exercised in consultation with each other and commensurate with their respective areas of responsibility set forth in previous Presidential actions under the International Emergency Economic Powers Act (50 U.S.C. 1701 et seq.), including E.O. 13224, and the functions and authorities set forth in section 111(b) of CAATSA to be exercised commensurate with their respective areas of responsibility set forth in the delegation memorandum.

Sanctions applicable with respect to a foreign person pursuant to E.O. 13224. E.O. 13224 blocks and prohibits all transactions in, with certain exceptions, all property and interests in property of foreign persons listed in the Annex to E.O. 13224 or persons designated pursuant to criteria set forth in that order by the Secretary of State or the Secretary of the Treasury. On October 13, 2017, OFAC designated the IRGC pursuant to E.O. 13224 and consistent with the CAATSA for its activities in support of the IRGC-Qods Force (82 FR 48591, October 18, 2017), which was designated pursuant to E.O. 13224 on October 25, 2007 (72 FR 65837, November 23, 2007).

Regulatory action. OFAC is taking this regulatory action pursuant to section 105(b) of CAATSA to extend the sanctions applicable pursuant to E.O. 13224 to foreign persons that are officials, agents, or affiliates of the IRGC. Subpart B of the Regulations currently implements the prohibitions contained in E.O. 13224. See, e.g., §§ 594.201 and 594.204. With this rule, OFAC is adding § 594.201(a)(5) to Subpart B of the Regulations to include the following as persons whose property and interests in property are blocked pursuant to the Regulations: Foreign persons that are identified on the Specially Designated Nationals and Blocked Persons List (SDN List) maintained by OFAC as officials, agents, or affiliates of the IRGC.

The names of persons whose property and interests in property are blocked pursuant to § 594.201(a) are published in the Federal Register and incorporated into OFAC's SDN List with the identifier “[SDGT].” Persons who have been identified by OFAC as officials, agents, or affiliates of the IRGC are identified by a special reference to the “IRGC” at the end of their entries on the SDN List, in addition to the reference to this part. For example, an affiliate of the IRGC whose property and interests in property are blocked pursuant to this part will have the program tags “[SDGT][IRGC]” at the end of its entry on the SDN List. In addition, OFAC is amending the delegation provision in § 594.802.

Public Participation

Because the Regulations involve a foreign affairs function, the provisions of Executive Order 12866 and the Administrative Procedure Act (5 U.S.C. 553) requiring notice of proposed rulemaking, opportunity for public participation, and delay in effective date, as well as the provisions of Executive Order 13771, are inapplicable. Because no notice of proposed rulemaking is required for this rule, the Regulatory Flexibility Act (5 U.S.C. 601-612) does not apply.

Paperwork Reduction Act

The collections of information related to the Regulations are contained in 31 CFR part 501 (the “Reporting, Procedures and Penalties Regulations”). Pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3507), those collections of information have been approved by the Office of Management and Budget under control number 1505-0164. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid control number.

List of Subjects in 31 CFR Part 594

Administrative practice and procedure, Banks, Banking, Blocking of assets, Credit, Penalties, Reporting and recordkeeping requirements, Terrorism.

For the reasons set forth in the preamble, the Department of the Treasury's Office of Foreign Assets Control amends part 31 CFR part 594 to read as follows:

PART 594—GLOBAL TERRORISM SANCTIONS REGULATIONS 1. The authority citation for part 594 is revised to read as follows: Authority:

3 U.S.C. 301; 22 U.S.C. 287c; 31 U.S.C. 321(b); 50 U.S.C. 1601-1651, 1701-1706; Pub. L. 101-410, 104 Stat. 890 (28 U.S.C. 2461 note); Pub. L. 110-96, 121 Stat. 1011; Pub. L. 115-44, 131 Stat. 886 (22 U.S.C. 9401 et seq.), E.O. 13224, 66 FR 49079, 3 CFR, 2001 Comp., p. 786; E.O. 13268, 67 FR 44751, 3 CFR, 2002 Comp., p. 240; E.O. 13284, 68 FR 4075, 3 CFR, 2003 Comp., p. 161; E.O. 13372, 70 FR 8499, 3 CFR, 2006 Comp., p. 159.

Subpart B—Prohibitions 2. Remove the word “or” at the end of paragraph (a)(3); remove the period at the end of paragraph (a)(4)(ii) and add the text “; or” in its place; add new paragraph (a)(5); and revise Note 2 to paragraph (a) of § 594.201 to read as follows:
§ 594.201 Prohibited transactions involving blocked property.

(a) * * *

(5) Foreign persons that are identified on the Specially Designated Nationals and Blocked Persons List (SDN List) maintained by the Office of Foreign Assets Control as officials, agents, or affiliates of Iran's Islamic Revolutionary Guard Corps (IRGC).

Note 2 to paragraph (a) of § 594.201:

The names of persons whose property and interests in property are blocked pursuant to § 594.201(a) are published in the Federal Register and incorporated into the Office of Foreign Assets Control's SDN List with the identifier “[SDGT].” Persons who have been identified by the Office of Foreign Assets Control as officials, agents, or affiliates of the IRGC are identified by a special reference to the “IRGC” at the end of their entries on the SDN List, in addition to the reference to this part. For example, an affiliate of the IRGC whose property and interests in property are blocked pursuant to this part will have the program tags “[SDGT] [IRGC]” at the end of its entry on the SDN List. The SDN List is accessible through the following page on the Office of Foreign Assets Control's Web site: http://www.treasury.gov/sdn. Additional information pertaining to the SDN List can be found in appendix A to this chapter. See § 594.412 concerning entities that may not be listed on the SDN List but whose property and interests in property are nevertheless blocked pursuant to paragraph (a) of this section.

Subpart H—Procedures 3. Revise § 594.802 to read as follows:
§ 594.802 Delegation by the Secretary of the Treasury.

Any action that the Secretary of the Treasury is authorized to take pursuant to Executive Order 13224 of September 23, 2001, and any further Executive orders relating to the national emergency declared therein, and any action that the Secretary of the Treasury is authorized to take pursuant to Presidential Memorandum of October 11, 2017: Delegation of Certain Functions and Authorities under the Countering America's Adversaries Through Sanctions Act of 2017 or any further Presidential action relating to Title I of the Countering America's Adversaries Through Sanctions Act of 2017 (Pub. L. 115-44), may be taken by the Director of the Office of Foreign Assets Control or by any other person to whom the Secretary of the Treasury has delegated authority so to act.

Dated: October 23, 2017. John E. Smith, Director, Office of Foreign Assets Control. Dated: October 24, 2017. Sigal P. Mandelker, Under Secretary, Office of Terrorism and Financial Intelligence, Department of the Treasury.
[FR Doc. 2017-23433 Filed 10-30-17; 8:45 am] BILLING CODE 4810-AL-P
DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 117 [Docket No. USCG-2017-1012] Drawbridge Operation Regulation; China Basin, San Francisco, CA 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 3rd Street Drawbridge across China Basin, mile 0.0 at San Francisco, CA. The deviation is necessary to allow participants to cross the bridge during the Leukemia Lymphoma Society Light the Night Walk. This deviation allows the bridge to remain in the closed-to-navigation position during the deviation period.

DATES:

This deviation is effective from 6 p.m. to 9 p.m. on November 16, 2017.

ADDRESSES:

The docket for this deviation, USCG-2017-1012, 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 Carl T. Hausner, Chief, Bridge Section, Eleventh Coast Guard District; telephone 510-437-3516; email [email protected]

SUPPLEMENTARY INFORMATION:

The City of San Francisco has requested a temporary change to the operation of the 3rd Street Drawbridge over China Basin, mile 0.0, at San Francisco, CA. The drawbridge navigation span provides a vertical clearance of 3 feet above Mean High Water in the closed-to-navigation position. The draw opens on signal if at least one hour notice is given, as required by 33 CFR 117.149. Navigation on the waterway is recreational.

The drawspan will be secured in the closed-to-navigation position from 6 p.m. to 9 p.m. on November 16, 2017, to allow participants to cross the bridge during the Leukemia Lymphoma Society Light the Night Walk. This temporary deviation has been coordinated with the waterway users. No objections to the proposed temporary deviation were raised.

Vessels able to pass through the bridge in the closed 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. The Coast Guard will also inform the users of the waterway 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: October 25, 2017. Carl T. Hausner, District Bridge Chief, Eleventh Coast Guard District.
[FR Doc. 2017-23608 Filed 10-30-17; 8:45 am] BILLING CODE 9110-04-P
DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket Number USCG-2017-0973] RIN 1625-AA00 Safety Zone, Savannah River, Savannah, GA AGENCY:

Coast Guard, DHS.

ACTION:

Temporary final rule.

SUMMARY:

The Coast Guard is establishing a temporary safety zone for navigable waters on the Savannah River in Savannah, GA from statute mile 13 to statute mile 15. The safety zone is needed to protect personnel, vessels, and the marine environment from potential hazards created by a boat parade. Entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port (COTP) Savannah or a designated representative.

DATES:

This rule is effective from 4 p.m. to 11 p.m. on November 25, 2017.

ADDRESSES:

To view documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov, type USCG-2017-0973 in the “SEARCH” box and click “SEARCH.” Click on Open Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT:

If you have questions on this rule, call or email MST2 Adam White, Marine Safety Unit Savannah Office of Waterways Management, Coast Guard; telephone 912-652-4353, extension 233, or email [email protected]

SUPPLEMENTARY INFORMATION:

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

The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because doing so would be impracticable and contrary to the public interest. Immediate action is needed to respond to the potential safety hazards associated with a boat parade. The Coast Guard received information on October 5, 2017 regarding the operations beginning on November 25, 2017. The operation would begin before the rulemaking process would be completed. Because of the dangers posed by the parade, the safety zone is necessary to provide for the safety of persons, vessels, and the marine environment in the event area. Therefore, it is impracticable and contrary to the public interest to delay promulgating this rule, as it is necessary to protect the safety of waterway users.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register. Delaying the effective date of this rule would be impracticable because immediate action is needed to respond to the potential safety hazards associated with the boat parade.

III. Legal Authority and Need for Rule

The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The COTP Savannah has determined that potential hazards associated with the boat parade starting November 25, 2017, will be a safety concern for anyone on the Savannah River in Savannah, GA from statute mile 13 to statute mile 15. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone while the parade is underway.

IV. Discussion of the Rule

This rule establishes a safety zone from 4 p.m. until 11 p.m. on November 25, 2017. The safety zone will cover all navigable waters on the Savannah River from statute mile 13 to statute mile 15. The duration of the zone is intended to protect personnel, vessels, and the marine environment in these navigable waters while the parade is underway. No vessel or person will be permitted to enter, transit through, anchor in, or remain within the safety zone without obtaining permission from the COTP or a designated representative.

V. Regulatory Analyses

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

A. Regulatory Planning and Review

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

This regulatory action determination is based on the size, location, duration, and time-of-day of the safety zone. The safety zone affects only a small portion of the Savannah River for seven hours during the evening when vessel traffic is normally lower. Moreover, vessels and persons seeking to enter, transit through, anchor in, or remain within the regulated area may seek authority from the COTP or a designated representative. The Coast Guard will provide notification of the regulated area to the local maritime community by Local Notice to Mariners, Broadcast Notice to Mariners via VHF-FM marine channel 16, and Marine Safety Security Bulletin release.

B. Impact on Small Entities

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

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

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

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

C. Collection of Information

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

D. Federalism and Indian Tribal Governments

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

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

E. Unfunded Mandates Reform Act

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

F. Environment

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a safety zone lasting only seven hours that will prohibit entry on the Savannah River in Savannah, GA from statute mile 13 to statute mile 15. It is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. A Record of Environmental Consideration supporting this determination is available in the docket where indicated under ADDRESSES.

G. Protest Activities

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

List of Subjects in 33 CFR Part 165

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

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:

PART 165—REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS 1. The authority citation for part 165 continues to read as follows: Authority:

33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegations No. 0170.1.

2. Add § 165.T07-0973 to read as follows:
§ 165.T07-0973 Safety Zone; Savannah Harbor Boat Parade, Savannah River, Savannah, GA.

(a) Regulated area. The following regulated area is a safety zone: All waters of the Savannah River from statute mile 13 to statute mile 15.

(b) Definition. As used in this section, “designated representative” means Coast Guard Patrol Commanders, including Coast Guard coxswains, petty officers, and other officers operating Coast Guard vessels or aircraft, and federal, state, and local officers designated by or assisting the Captain of the Port (COTP) Savannah in the enforcement of the regulated areas.

(c) Regulations. (1) All persons and vessels are prohibited from entering, transiting through, anchoring in, or remaining within the regulated area of the safety zone unless authorized by the COTP Savannah or a designated representative.

(2) Persons or vessels desiring to enter, transit through, anchor in, or remain within the safety zone may contact COTP Savannah by telephone at (912) 652-4353, or a designated representative via VHF radio on channel 16, to request authorization. If authorization to enter, transit through, anchor in, or remain within the regulated area is granted by the COTP Savannah or a designated representative, all persons and vessels receiving such authorization must comply with the instructions of the COTP Savannah or a designated representative.

(3) The Coast Guard will provide notice of the regulated areas by Local Notice to Mariners, Broadcast Notice to Mariners, Marine Safety Security Bulletins, and on-scene designated representatives.

(e) Effective and enforcement period. This rule is effective and will be enforced on November 25, 2017 from 4 p.m. to 11 p.m.

Dated: October 24, 2017. Norman C. Witt, Commander, U.S. Coast Guard, Captain of the Port Savannah.
[FR Doc. 2017-23616 Filed 10-30-17; 8:45 am] BILLING CODE 9110-04-P
DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket Number USCG-2017-0891] RIN 1625-AA00 Safety Zone; Monongahela River, Monongahela, PA AGENCY:

Coast Guard, DHS.

ACTION:

Temporary final rule.

SUMMARY:

The Coast Guard is establishing a temporary safety zone for navigable waters of the Monongahela River from mile marker (MM) 31.5 to (MM) 32.5. The safety zone is necessary to provide for the safety of life on these navigable waters near Monongahela, PA from potential hazards created by a land based fireworks display. Entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port Marine Safety Unit Pittsburgh (COTP) or a designated representative.

DATES:

This rule is effective from 8:30 p.m. through 10:30 p.m. on November 17, 2017.

ADDRESSES:

To view documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov, type USCG-2017-0891 in the “SEARCH” box and click “SEARCH.” Click on Open Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT:

If you have questions on this rule, call or email MST1 Jennifer Haggins, Marine Safety Unit Pittsburgh, U.S. Coast Guard; telephone 412-221-0807, email [email protected]

SUPPLEMENTARY INFORMATION:

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

The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because it is impracticable.

The Coast Guard received a notice of the event on September 7, 2017. After receiving and fully reviewing the event information, circumstances and exact location, the Coast Guard determined that a safety zone was necessary to protect personnel, vessels, and the marine environment from potential hazards created from a land based fireworks display. It would be impracticable to complete the full NPRM process for this safety zone because we need to establish it by November 17, 2017 and lack sufficient time to provide a reasonable comment period and then consider those comments before issuing the rule.

We are issuing this rule, and under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making it effective less than 30 days after publication in the Federal Register. Delaying this rule would be contrary to the public interest of ensuring the safety of spectators and vessels during the event and action is necessary to prevent possible loss of life and property.

III. Legal Authority and Need for Rule

The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The Captain of the Port Pittsburgh (COTP) has determined that a safety zone is needed on November 17, 2017. This rule is needed to protect personnel, vessels, and the marine environment from potential hazards created from a land based fireworks display.

IV. Discussion of the Rule

This rule establishes a safety zone from 8:30 p.m. through 10:30 p.m. on November 17, 2017. The safety zone will cover all navigable waters on the Monongahela River from MM 31.5 to MM 32.5. The duration of the safety zone is intended to protect personnel, vessels, and the marine environment from potential hazards created from a land based fireworks display. No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative.

V. Regulatory Analyses

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

A. Regulatory Planning and Review

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

This regulatory action determination is based on the size, location, and duration of the safety zone. This safety zone impacts a small portion of the waterway and for a limited duration of two hours. Vessel traffic will be informed about the safety zone through local notices to mariners. Moreover, the Coast Guard will issue Broadcast Notices to Mariners via VHF-FM marine channel 16 about the zone and the rule allows vessels to seek permission to transit the zone.

B. Impact on Small Entities

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

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

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

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

C. Collection of Information

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

D. Federalism and Indian Tribal Governments

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

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

E. Unfunded Mandates Reform Act

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

F. Environment

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a safety zone lasting two hours that will prohibit entry on the Monongahela River from MM 31.5 to MM 32.5, during the land based fireworks event. It is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. A Record of Environmental Consideration supporting this determination is available in the docket where indicated under ADDRESSES.

G. Protest Activities

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

List of Subjects in 33 CFR Part 165

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

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:

PART 165—REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS 1. The authority citation for part 165 continues to read as follows: Authority:

33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 0170.1.

2. Add § 165.T08-0891 to read as follows:
§ 165.T08-0891 Safety Zone: Monongahela River, Monongahela, PA.

(a) Location. The following area is a safety zone: All navigable waters of the Monongahela River from mile marker (MM) 31.5 to MM 32.5.

(b) Effective date. This rule is effective from 8:30 p.m. through 10:30 p.m. on November 17, 2017.

(c) Regulations. (1) In accordance with the general regulations in § 165.23, entry into this zone is prohibited unless authorized by the Captain of the Port Marine Safety Unit Pittsburgh (COTP) or a designated representative.

(2) Persons or vessels requiring entry into or passage through the zone must request permission from the COTP or a designated representative. The designated representative may be contacted at 412-221-0807.

(3) All persons and vessels shall comply with the instructions of the COTP or a designated representative. Designated representatives include United States Coast Guard commissioned, warrant, and petty officers.

(d) Information broadcasts. The Captain COTP or a designated representative will inform the public through broadcast notices to mariners of the enforcement period for the safety zone as well as any changes in the planned schedule.

Dated: October 26, 2017. L. McClain, Jr., Commander, Captain of the Port, U.S. Coast Guard.
[FR Doc. 2017-23652 Filed 10-30-17; 8:45 am] BILLING CODE 9110-04-P
POSTAL REGULATORY COMMISSION 39 CFR Part 3000 [Docket No. RM2017-4; Order No. 4178] Supplemental Standards of Ethical Conduct AGENCY:

Postal Regulatory Commission.

ACTION:

Final rule.

SUMMARY:

The Commission revises its existing ethics rules to replace those duplicative rules with rules that reflect the Commission's current regulatory role under the Postal Accountability and Enhancement Act.

DATES:

Effective date: November 30, 2017.

FOR FURTHER INFORMATION CONTACT:

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

SUPPLEMENTARY INFORMATION:

Table of Contents I. Introduction II. Background III. Comments IV. Commission Analysis V. Ordering Paragraphs I. Introduction

On May 24, 2017, the Postal Regulatory Commission (Commission) issued a notice of proposed rulemaking to amend the Commission's ethics rules, 39 CFR subpart A of part 3000.1 On the same day, with the concurrence of the Office of Government Ethics (OGE), the Commission also issued a notice of proposed rulemaking to amend the supplemental standards of ethical conduct, 5 CFR part 5601, applicable to Commission employees.2

1 82 FR 23766 (May 24, 2017). The Commission posted this document on its Web site on May 19, 2017. Notice of Proposed Rulemaking on Amendments to Ethics Rules, May 19, 2017 (Order No. 3907).

2 82 FR 23758 (May 24, 2017). The Commission posted this document on its Web site on May 19, 2017. Order No. 3906, Notice of Proposed Rulemaking on Amendments to Supplemental Standards of Ethical Conduct for Employees of the Postal Regulatory Commission, May 19, 2017.

Executive branch employees are subject to multiple federal ethics laws, regulations issued by OGE, and executive orders. Because existing 39 CFR subpart A of part 3000 contains several rules that are duplicative of rules contained in 5 CFR part 2638 and 5 CFR part 5601, as amended, the Commission will revise existing 39 CFR subpart A of part 3000. The Commission will replace those duplicative rules with rules that reflect the Commission's current regulatory role under the Postal Accountability and Enhancement Act (PAEA), Public Law 109-435, 120 Stat. 3198 (2006). The revised rules will treat employees' and former employees' interactions with the Postal Service substantially the same as if those interactions were with entities that are not part of the federal government.

II. Background

The ethics rules contained in 39 CFR subpart A of part 3000 were adopted in a 1971 rulemaking, in which the Civil Service Commission promulgated employee conduct regulations on the Commission's behalf. 36 FR 5412 (Mar. 23, 1971). In 1993, the Commission collaborated with OGE to revise the Commission's ethics rules in 39 CFR subpart A of part 3000. 58 FR 42873, 42874 (Aug. 12, 1993). The Commission amended the ethics rules in 2001 to eliminate a redundant provision. 66 FR 32544, 32545 (Jun. 15, 2001).

In 2006, the PAEA changed the agency's name from the Postal Rate Commission to the Postal Regulatory Commission and made several changes to the Commission's regulatory role. In 2007, the Commission amended its ethics rules to correct the statutory authority and the agency's name, both of which were changed by the PAEA. 72 FR 33164, 33165 (Jun. 15, 2007). In 2016, the Commission amended its ethics rules to redesignate the numbering to be consistent with the Federal Register Document Drafting Handbook and to correct the listed authority. 81 FR 42534, 42540 (Jun. 30, 2016). Neither amendment modernized the Commission's ethics rules to reflect the PAEA's enhancements to the Commission's responsibilities.

Because the ethics rules in existing 39 CFR subpart A of part 3000 are redundant to rules contained in title 5 of the Code of Federal Regulations, the Commission undertook this rulemaking to streamline its regulations. Order No. 3907 at 4-5. Further, the PAEA's changes to the Commission's responsibilities drive the need to modernize the ethics rules to ensure that consistent rules will apply to employees' and former employees' interactions with entities outside the federal government and with the Postal Service.

III. Comments

The Commission received two sets of comments pertaining to the proposed revisions to the supplemental standards of ethical conduct and the Commission's ethics rules.

Sum Comments. The Commission received the following comment through the www.federalregister.gov Web site: “Any deletion of ethical conduct would not be in the best interest of the American people due to transparency.” 3

3 Comment Received from Beth Sum, June 19, 2017 (Sum Comments). For transparency, this comment was posted to the Commission's Web site and associated with this docket.

PR Comments. The Public Representative supports the proposed revisions.4 He deems it “critical that the Commission's ethics rules accurately reflect its role as a regulator and are reflective of the agency's procedures.” PR Comments at 2. He concludes that the proposed revisions serve the public interest, reinforce public perception of the Commission's integrity, and increase accessibility and transparency. Id. He states that “the Commission's judgment that the standards applied to private firms should apply to the Postal Service is reasonable.” Id. at 2-3. He also states that the proposed revisions help to “maintain the public's confidence that Commission staff are fulfilling their roles impartially.” Id. at 2.

4 Public Representative Comments on Notices of Proposed Rulemaking on Amendments to Ethics Rules and Amendments to Supplemental Standards of Ethical Conduct for Employees of the Postal Regulatory Commission, June 26, 2017 (PR Comments). The Public Representative also filed a motion for late acceptance of his comments. Motion of Public Representative for Late Acceptance of Comments, June 26, 2017 (Motion). The Motion is granted.

He observes that the proposed deletions are primarily editorial revisions made to delete duplicative and outdated sections. Id. at 3. He notes that the proposed deletions will not limit the ethical obligations of Commission employees. Id.

IV. Commission Analysis

Neither commenter suggested changes to the proposed rules. The Public Representative supports the proposed rules. Id. at 2-3. In response to the concern expressed in the Sum Comments, the Commission reiterates its commitment to upholding the highest ethical standards. As executive branch employees, Commission employees remain subject to several statutes governing conflicts of interests (see, e.g., 18 U.S.C. 201-219); the standards of ethical conduct appearing in Executive Order 12674, as amended by Executive Order 12731; 5 and regulations promulgated by OGE relating to several issues, including financial disclosure, the standards of ethical conduct, and post-employment conflicts of interest (see, e.g., 5 CFR parts 2634, 2635, and 2641). Commission employees are also subject to the supplemental standards of ethical conduct, 5 CFR part 5601, which are also being revised to reflect the Commission's modern regulatory role under the PAEA and to remove duplicative and outdated provisions.6 The regulations at issue in this Order, the ethics rules applicable to Commission employees only, concern restrictions imposed upon Commission employees in addition to these laws and standards. The proposed revisions remain consistent with these laws and do not abrogate their application in any way. Streamlining the Commission's ethics rules supports OGE's mission to establish a single, comprehensive, and clear set of executive branch standards of ethical conduct in accordance with Executive Order 12731. The proposed revisions will not lead to any reduction in the ethical obligations of Commission employees. Ultimately, the proposed revisions will enhance the Commission's adherence to ethical conduct by more accurately reflecting the Commission's modern regulatory role under the PAEA.

5See Executive Order No. 12674, 54 FR 15159 (Apr. 12, 1989); Executive Order No. 12731, 55 FR 42547 (Oct. 17, 1990).

6 Order No. 4177, Order Amending Supplemental Standards of Ethical Conduct for Employees of the Postal Regulatory Commission, October 25, 2017.

Specifically, the Commission deletes the four rules in existing 39 CFR subpart A of part 3000, which are redundant to provisions contained in title 5 of the Code of Federal Regulations, as displayed in the following table:

Existing subpart A of part 3000 Description of the existing rule Duplicative provision contained in title 5 § 3000.5 Cross-reference to employee ethical conduct standards and financial disclosure regulations 5 CFR 5601.101(a), as amended by Order No. 4177. § 3000.10 Memorializing the duties of the Designated Agency Ethics Official (DAEO) for the Commission 5 CFR part 2638. § 3000.15 Memorializing the prohibition against financial conflicts of interest 5 CFR 5601.102, as amended by Order No. 4177. § 3000.20 Prohibited outside employment, prior approval to engage in outside employment, and disqualification when seeking non-federal employment 5 CFR 5601.104(a) and (b) and 5601.103(a), as amended by Order No. 4177.

Further, as detailed in Order No. 3907, the Commission issues replacement rules that will improve transparency and the ability of Commission employees to adhere to the highest ethical standards. Specifically, these rules treat employees' and former employees' interactions with the Postal Service substantially the same as if those interactions were with entities that are not part of the federal government. As noted by the Public Representative, this will serve the public interest and reinforce public perception of the Commission's integrity with respect to the oversight of the Postal Service. See PR Comments at 2.

The Commission makes two editorial revisions. First, the Commission corrects the format of the cross-references to title 5 of the Code of Federal Regulations in proposed §§ 3000.10 and 3000.15.

Second, the Commission clarifies the text of proposed § 3000.10(a), relating to the obligation of Commission employees seeking employment with the Postal Service to provide written notice of disqualification to the DAEO. The Commission adds a cross-reference to reflect that this obligation supplements the requirement that Commission employees seeking non-federal employment provide written notice of disqualification to the DAEO. Also, the Commission adds a procedural sentence memorializing that the DAEO will inform the employee and the employee's supervisor in writing of each matter from which the employee is disqualified from participating. This clarifying revision will better ensure that the employee is disqualified from all applicable matters. For these reasons and those reasons detailed in Order No. 3907, the Commission adopts the proposed rules without substantial changes.

V. Ordering Paragraphs

It is ordered:

1. Subpart A of part 3000 of title 39, Code of Federal Regulations, is amended as set forth below the signature of this Order effective 30 days after the date of publication of this Order in the Federal Register.

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

List of Subjects in 39 CFR Part 3000

Conflict of interests.

By the Commission.

Stacy L. Ruble, Secretary.

For the reasons discussed in the preamble, the Commission amends chapter III of title 39 of the Code of Federal Regulations as follows:

CHAPTER III—POSTAL REGULATORY COMMISSION 1. Under the authority of 39 U.S.C. 503, remove the heading of subchapter A. PART 3000—STANDARDS OF CONDUCT 2. The authority citation for part 3000 continues to read as follows: Authority:

39 U.S.C. 503; 504, 3603; E.O. 12674; 54 FR 15159; 3 CFR,1989 Comp., p. 215, as modified by E.O. 12731, 56 FR 42547, 3 CFR, 1990 Comp., p. 396, 5 CFR parts 2634 and 2635.

3. Revise subpart A of part 3000 to read as follows: Subpart A—General Provisions Sec. 3000.5 Post-employment restrictions. 3000.10 Additional required notification of disqualification when seeking employment. 3000.15 Additional restriction on acceptance of anything of value. 3000.20 [Reserved]
§ 3000.5 Post-employment restrictions.

All former employees of the Postal Regulatory Commission (Commission) are subject to the following restrictions on appearance and practice before the Commission on behalf of any participant, including the United States Postal Service (Postal Service):

(a) No former employee of the Commission may practice or act as an attorney, expert witness, or representative in connection with any proceeding or matter before the Commission that the former employee has handled, advised, or participated in the consideration of while in the service of the Commission.

(b) No former employee of the Commission may within 1 year after his or her employment has ceased, practice before or act as an attorney, expert witness, or representative in connection with any proceeding or matter before the Commission that was under the official responsibility of such individual, as defined in 18 U.S.C. 202(b), while in the service of the Commission.

§ 3000.10 Additional required notification of disqualification when seeking employment.

(a) Notwithstanding 5 CFR 2635.603(a), an employee that seeks employment with the Postal Service must provide written notice of disqualification to the Designated Agency Ethics Official (DAEO) consistent with 5 CFR 5601.103(a). The DAEO will inform the employee and the employee's supervisor in writing of each matter from which the employee is disqualified from participating.

(b) An employee may withdraw written notice under paragraph (a) of this section consistent with 5 CFR 5601.103(b).

§ 3000.15 Additional limitation on acceptance of anything of value.

Regardless of 5 CFR 2635.203(b)(7), a Commission employee may not accept a gift from the Postal Service, unless another exception or exclusion to 5 CFR 2635.203 applies or a waiver is granted by the DAEO.

§ 3000.20 [Reserved]
[FR Doc. 2017-23576 Filed 10-30-17; 8:45 am] BILLING CODE 7710-FW-P
FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 61 [WC Docket Nos. 16-143, 05-25, GN Docket No. 13-5, RM-10593; FCC 17-43] Business Data Services in an Internet Protocol Environment; Technology Transitions; Special Access for Price Cap Local Exchange Carriers; AT&T Corporation Petition for Rulemaking AGENCY:

Federal Communications Commission.

ACTION:

Final rule; announcement of effective date.

SUMMARY:

In this document, the Commission announces that the Office of Management and Budget (OMB) has approved, for a period of three years, an information collection associated with the Commission's Business Data Services Report and Order, FCC 17-43, which, among other things, adopted an X-factor of two percent and required price cap ILECs to make a one-time filing to revise their Tariff Review Plans (TRPs) to implement the new X-factor to become effective on December 1, 2017. In particular, the Commission amended its rules to state that the X-factor shall equal 2 percent effective December 1, 2017. This document is consistent with the Order, which stated that the Commission would publish a document in the Federal Register announcing the effective date of this rule.

DATES:

The amendment to 47 CFR 61.45(b)(1)(iv), published at June 2, 2017, 82 FR 25660, is effective October 31, 2017.

FOR FURTHER INFORMATION CONTACT:

William Kehoe, Pricing Policy Division, Wireline Competition Bureau, at (202) 418-7122, or email: [email protected]

SUPPLEMENTARY INFORMATION:

This document announces that, on October 13, 2017, OMB approved, for a period of three years, the information collection requirement relating to § 61.45(b)(1)(iv) of the Commission's rules, as contained in the Commission's Business Data Services Report and Order, FCC 17-43, published at 82 FR 25660, June 2, 2017. The OMB Control Number is 3060-0400. The Commission publishes this document as an announcement of the effective date of the rules. If you have any comments on the burden estimates listed below, or how the Commission can improve the collections and reduce any burdens caused thereby, please contact Nicole Ongele, Federal Communications Commission, Room 1-A620, 445 12th Street SW., Washington, DC 20554. Please include the OMB Control Number, 3060-0400, in your correspondence. The Commission will also accept your comments via email at [email protected]

To request materials in accessible formats for people with disabilities (Braille, large print, electronic files, audio format), send an email to [email protected] or call the Consumer and Governmental Affairs Bureau at (202) 418-0530 (voice), (202) 418-0432 (TTY).

Synopsis

As required by the Paperwork Reduction Act of 1995 (44 U.S.C. 3507), the FCC is notifying the public that it received final OMB approval on October 13, 2017, for the information collection requirements contained in the modifications to the Commission's rules in 47 CFR part 61. Under 5 CFR part 1320, an agency may not conduct or sponsor a collection of information unless it displays a current, valid OMB Control Number.

No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act that does not display a current, valid OMB Control Number. The OMB Control Number is 3060-0400.

The foregoing notice is required by the Paperwork Reduction Act of 1995, Public Law 104-13, October 1, 1995, and 44 U.S.C. 3507.

The total annual reporting burdens and costs for the respondents are as follows:

OMB Control Number: 3060-0400.

OMB Approval Date: October 13, 2017.

OMB Expiration Date: October 31, 2020.

Title: Part 61, Tariff Review Plan.

Form Number: N/A.

Respondents: Business or other for-profit entities.

Number of Respondents and Responses: 2,749 respondents; 4,165 responses.

Estimated Time per Response: 0.50 hours—53 hours.

Frequency of Response: One-time, biennial and on-occasion reporting requirements.

Obligation to Respond: Required to obtain or retain benefits. Statutory authority for this information collection (IC) is contained in 47 U.S.C. 10(a) of the Communications Act of 1934, as amended.

Total Annual Burden: 60,878 hours.

Total Annual Cost: No Cost.

Nature and Extent of Confidentiality: Respondents are not being asked to submit confidential information to the Commission. If the Commission requests respondents to submit information which respondents believe are confidential, respondents may request confidential treatment of such information under 47 CFR 0.459 of the Commission's rules.

Privacy Act: No impact(s).

Needs and Uses: The Commission has developed standardized Tariff Review Plans (TRPs) that set forth the summary material that incumbent LECs (LECs) file to support revisions to the rates in their interstate access service tariffs. The TRPs display basic data on rate development in a consistent manner, thereby facilitating review of the incumbent LEC rate revisions by the Commission and interested parties. The TRPs have served this purpose effectively in past years.

On April 20, 2017, the Commission adopted the Business Data Services Report and Order, FCC 17-43, reforming the business data services/special access regulations for incumbent and competitive LECs by detariffing certain business data services and modifying the regulatory obligations for those business data services that will remain tariffed. Additionally, the Order adopted an X-factor of two percent and required price cap ILECs to make a one-time filing to revise their TRPs to implement the new X-factor to become effective on December 1, 2017. In particular, the Commission amended § 61.45(b)(1)(iv) of its rules to state that the X-factor shall equal 2 percent effective December 1, 2017. To ease the burden on industry, the only factor that changes in the revised TRPs is the X-factor. Base period demand and the value of GDP-PI will stay constant for this particular filing.

Federal Communications Commission. Marlene H. Dortch, Secretary, Office of the Secretary.
[FR Doc. 2017-23621 Filed 10-30-17; 8:45 am] BILLING CODE 6712-01-P
DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 622 [Docket No. 140819686-5999-02] RIN 0648-XF779 Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; Snapper-Grouper Fishery of the South Atlantic; 2017 Recreational Accountability Measure and Closure for Greater Amberjack AGENCY:

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

ACTION:

Temporary rule; closure.

SUMMARY:

NMFS implements an accountability measure (AM) for the recreational sector of greater amberjack in the South Atlantic exclusive economic zone (EEZ) through this temporary rule. NMFS estimates that recreational landings have reached the recreational annual catch limit (ACL) for greater amberjack in the South Atlantic. Therefore, NMFS closes the recreational sector for greater amberjack in the South Atlantic EEZ for the remainder of the current fishing year (see DATES). This closure is necessary to protect the greater amberjack resource in the South Atlantic.

DATES:

This rule is effective from 12:01 a.m., local time, October 31, 2017, until 12:01 a.m. local time, on March 1, 2018.

FOR FURTHER INFORMATION CONTACT:

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

SUPPLEMENTARY INFORMATION:

The snapper-grouper fishery of the South Atlantic includes greater amberjack and is managed under the Fishery Management Plan for the Snapper-Grouper Fishery of the South Atlantic Region (FMP). The FMP was prepared by the South Atlantic Fishery Management Council (Council) and is implemented by NMFS under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) by regulations at 50 CFR part 622.

The recreational ACL for South Atlantic greater amberjack is 1,167,837 lb (529,722 kg), round weight, as specified at 50 CFR 622.193(k)(2)(i). The fishing year for South Atlantic greater amberjack is from March 1 through the end of February (50 CFR 622.7(d)). Under the recreational AM at 50 CFR 622.193(k)(2)(i), when landings of the greater amberjack recreational sector reach, or are projected to reach, its ACL, NMFS is required to close the recreational sector for greater amberjack by filing a notification to that effect with the Office of the Federal Register unless NMFS determines that no closure is necessary based on the best scientific information available.

NMFS has determined that the recreational ACL has been reached in the current fishing year of March 1, 2017, through February 28, 2018, and that a closure is necessary. Therefore, this temporary rule implements an AM to close the greater amberjack recreational sector in the South Atlantic for the remainder of the current fishing year. As a result, the recreational sector for greater amberjack in the South Atlantic EEZ will close effective at 12:01 a.m., local time October 31, 2017.

On October 18, 2017, NMFS closed the commercial sector of greater amberjack in the South Atlantic because the sector had reached the commercial quota (equivalent to the commercial ACL) (82 FR 47640, October 13, 2017). Because the commercial sector for South Atlantic greater amberjack has already closed for the remainder of the current fishing year, all harvest of South Atlantic greater amberjack will end on October 31, 2017. Both the commercial and recreational sectors for South Atlantic greater amberjack will reopen on March 1, 2018, the start of the next fishing year.

During this closure, the bag and possession limits for greater amberjack in or from the South Atlantic EEZ are zero. The prohibition on harvest or possession of greater amberjack applies on board a vessel for which a valid Federal commercial or charter vessel/headboat permit for South Atlantic snapper-grouper has been issued, without regard to where the greater amberjack was harvested or possessed, i.e., in state or Federal waters.

Classification

The Regional Administrator for the NMFS Southeast Region has determined this temporary rule is necessary for the conservation and management of South Atlantic greater amberjack and is consistent with the Magnuson-Stevens Act and other applicable laws.

This action is taken under 50 CFR 622.193(k)(2)(i) and is exempt from review under Executive Order 12866.

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

This action responds to the best scientific information available. The Assistant Administrator for NOAA Fisheries (AA) finds that the need to immediately implement this action to close the recreational sector for greater amberjack constitutes good cause to waive the requirements to provide prior notice and opportunity for public comment on this temporary rule pursuant to the authority set forth in 5 U.S.C. 553(b)(B), because such procedures are unnecessary and contrary to the public interest. Such procedures are unnecessary because the rule implementing the AM itself has been subject to notice and comment, and all that remains is to notify the public of the closure. Such procedures are contrary to the public interest because of the need to immediately implement this action to protect South Atlantic greater amberjack. Prior notice and opportunity for public comment would require time and would potentially allow the recreational sector to exceed the recreational ACL.

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

Authority:

16 U.S.C. 1801 et seq.

Dated: October 26, 2017. Emily H. Menashes, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
[FR Doc. 2017-23667 Filed 10-26-17; 4:15 pm] BILLING CODE 3510-22-P
82 209 Tuesday, October 31, 2017 Proposed Rules DEPARTMENT OF ENERGY 10 CFR Parts 429 and 431 [EERE-2017-BT-TP-0055] Energy Conservation Program: Test Procedure for Distribution Transformers AGENCY:

Office of Energy Efficiency and Renewable Energy, Department of Energy.

ACTION:

Request for information; re-opening of public comment period.

SUMMARY:

On September 22, 2017, the U.S. Department of Energy (DOE) published a request for information (RFI) pertaining to the test procedures for distribution transformers. The RFI provided an opportunity for submitting written comments, data, and information by October 23, 2017. This document announces that the period for submitting comments on the RFI is to be re-opened until November 6, 2017.

DATES:

The comment period for the RFI, published on September 22, 2017 (82 FR 44347), is re-opened until November 6, 2017. DOE will accept written comments, data, and information in response to the RFI received no later than November 6, 2017.

ADDRESSES:

Interested persons are encouraged to submit comments by any of the following methods:

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

Email: [email protected] Include docket number EERE-2017-BT-TP-0055 in the subject line of the message. Submit electronic comments in WordPerfect, Microsoft Word, PDF, or ASCII file format, and avoid the use of special characters or any form of encryption.

Postal Mail: Appliance and Equipment Standards Program, U.S. Department of Energy, Building Technologies Office, Mailstop EE-5B, 1000 Independence Avenue SW., Washington, DC 20585-0121. If possible, please submit all items on a compact disc (CD), in which case it is not necessary to include printed copies.

Hand Delivery/Courier: Appliance and Equipment Standards Program, U.S. Department of Energy, Building Technologies Office, 950 L'Enfant Plaza SW., 6th Floor, Washington, DC 20024. Telephone: (202) 287-1445. If possible, please submit all items on a CD, in which case it is not necessary to include printed copies.

No telefacsimilies (faxes) will be accepted. For detailed instructions on submitting comments and additional information on the rulemaking process, see section III of the RFI published on September 22, 2017.

Docket: The docket for this activity, which includes Federal Register notices, comments, and other supporting documents/materials, is available for review at http://www.regulations.gov. All documents in the docket are listed in the http://www.regulations.gov index. However, some documents listed in the index, such as those containing information that is exempt from public disclosure, may not be publicly available.

The docket Web page can be found at http://www.regulations.gov/#!docketDetail;D=EERE-2017-BT-TP-0055. The docket Web page will contain simple instructions on how to access all documents, including public comments, in the docket.

FOR FURTHER INFORMATION CONTACT:

Mr. Jeremy Dommu, U.S. Department of Energy, Office of Energy Efficiency and Renewable Energy, Building Technologies Program, EE-5B 1000 Independence Avenue SW., Washington, DC 20585-0121. Telephone: (202) 586-9870. Email: [email protected].

Mary Greene, U.S. Department of Energy, Office of the General Counsel, GC-33, 1000 Independence Avenue SW., Washington, DC 20585-0121. Telephone: (202) 586-1817. Email: [email protected]

For further information on how to submit a comment, review other public comments and the docket, contact the Appliance and Equipment Standards Program staff at (202) 287-1445 or by email: [email protected]

SUPPLEMENTARY INFORMATION:

DOE published a RFI pertaining to the test procedure for distribution transformers on September 22, 2017. 82 FR 44347. The RFI initiated a data collection process to consider whether to amend DOE's test procedures for distribution transformers. DOE requested written comment, data, and information pertaining to these test procedures by October 23, 2017.

The National Electrical Manufacturers Association (NEMA), an interested party in the matter, requested a two-week extension of the public comment period for the RFI published in the Federal Register on October 5, 2017. (NEMA, No. 4, at p. 1)

DOE believes that re-opening the comment period to allow additional time for interested parties to submit comments is appropriate. Therefore, DOE is re-opening the comment period until November 6, 2017 to provide interested parties additional time to prepare and submit comments. Comments received between the original October 23 closing date and the new November 6 closing date are considered timely filed. Therefore, individuals who submitted late comments during the original comment period do not need to re-submit comments.

Issued in Washington, DC, on October 19, 2017. David Nemtzow, Director, Building Technologies Office, Energy Efficiency and Renewable Energy.
[FR Doc. 2017-23635 Filed 10-30-17; 8:45 am] BILLING CODE 6450-01-P
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 101 [Docket No. FDA-2017-N-0763] RIN 0910-AH43 Food Labeling: Health Claims; Soy Protein and Coronary Heart Disease AGENCY:

Food and Drug Administration, HHS.

ACTION:

Proposed rule.

SUMMARY:

The Food and Drug Administration (FDA, the Agency, or we) is proposing to revoke its regulation authorizing the use of health claims on the relationship between soy protein and coronary heart disease on the label or in the labeling of foods. We are taking this action based on our review of the totality of publicly available scientific evidence currently available and our tentative conclusion that such evidence does not support our previous determination that there is significant scientific agreement (SSA) among qualified experts for a health claim regarding the relationship between soy protein and reduced risk of coronary heart disease.

DATES:

Submit either electronic or written comments on the proposed rule by January 16, 2018.

ADDRESSES:

You may submit comments as follows. Late, untimely filed comments will not be considered. Electronic comments must be submitted on or before January 16, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of January 16, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

Electronic Submissions

Submit electronic comments in the following way:

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

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

Written/Paper Submissions

Submit written/paper submissions as follows:

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

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

Instructions: All submissions received must include the Docket No. FDA-2017-N-0763 for “Food Labeling: Health Claims; Soy Protein and Coronary Heart Disease.” Received comments, those received in a timely manner (see DATES and 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.” We will review this copy, including the claimed confidential information, in our consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

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

FOR FURTHER INFORMATION CONTACT:

Crystal Rivers, Center for Food Safety and Applied Nutrition (HFS-830), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1444.

SUPPLEMENTARY INFORMATION: Table of Contents I. Executive Summary A. Purpose of the Proposed Rule B. Summary of the Major Provisions of the Proposed Rule C. Legal Authority D. Costs and Benefits II. Table of Commonly Used Acronyms in This Document III. Background IV. Legal Authority V. Scientific Evidence Regarding the Relationship Between Soy Protein and CHD A. Overview of Data and Eligibility for a Health Claim B. Reevaluation of the Health Claim for Soy Protein Intake and CHD C. Assessment of Intervention Studies D. Assessment of Observational Studies VI. Strength of the Scientific Evidence VII. Proposal To Revoke § 101.82 VIII. Economic Analysis of Impacts IX. Proposed Effective Date X. Analysis of Environmental Impact XI. Paperwork Reduction Act of 1995 XII. Federalism XIII. References I. Executive Summary A. Purpose of the Proposed Rule

The proposed rule would revoke the regulation authorizing the use of a health claim regarding the relationship between soy protein and risk of coronary heart disease (CHD) (§ 101.82 (21 CFR 101.82)). In this proposed rule, we tentatively conclude, based on our reevaluation of the totality of the publicly available scientific evidence now available, that the evidence does not support our previous determination that there is SSA to support an authorized health claim for the relationship between soy protein and reduced risk of CHD.

In 1999, we authorized a health claim about the relationship between soy protein and a reduced risk of CHD (§ 101.82). In the Federal Register of December 21, 2007, we announced our intention to reevaluate the scientific evidence for this health claim and provided the opportunity for public comment (72 FR 72738). We explained that we were reevaluating the scientific basis for the soy protein and CHD health claim because new studies yielded varied and inconsistent findings (beneficial effect, no effect) from one trial to another. The results of these studies called into question the conclusions drawn from our prior review, which had served as the basis for authorizing the soy protein and reduced risk of CHD health claim. This proposed rule is the next step in our reevaluation.

B. Summary of the Major Provisions of the Proposed Rule

The proposed rule would revoke the soy protein and CHD claim in § 101.82 because it does not meet the SSA standard. Our decision about whether to authorize a health claim represents FDA's determination as to whether there is “significant scientific agreement” among qualified experts that the publicly available scientific evidence supports the substance/disease relationship that is the subject of a proposed health claim. In our reevaluation of the scientific evidence in this proposed rule, we use our approach outlined in the “Evidence-Based Review System for the Scientific Evaluation of Health Claims” (hereinafter the 2009 guidance) to evaluate the totality of publicly available scientific evidence to determine if the SSA standard in section 403(r)(3) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. (343(r)(3)) is met (Ref. 1). Our reevaluation of the totality of the publicly available scientific evidence indicates that, although some evidence suggests a relationship between soy protein intake and reduced risk of CHD, the totality of the evidence is inconsistent and not conclusive. Therefore, we have tentatively determined that the strength of the totality of the publicly available data does not meet the SSA standard for a relationship between soy protein intake and CHD risk.

C. Costs and Benefits

The costs of this proposed rule, if finalized, are relabeling the estimated 200 to 300 products currently making the health claim. We estimate total annualized costs of $35,000 to $81,000, when the relabeling costs are annualized over 20 years at a 7 percent discount rate. The initial one-time costs are $370,000 to $860,000.

The benefit of this rule is better information for the consumers who are considering purchasing products with soy protein. This may generate an unknown amount of increased consumer surplus. Some consumers may react to this new information by switching their consumption to products that they enjoy more, or products that still have an authorized health claim. By basing their consumption decisions on more recent and accurate scientific information, they may get more consumer surplus, in the form of enjoyment and/or potential health benefits, from the bundle of products they consume.

Table 1—Cost and Benefit Overview, USD, Annualized Over 20 Years Low estimate Mean High estimate Costs, 7 percent discount rate $35,000 $55,000 $81,000 Costs, 3 percent discount rate $25,000 $39,000 $58,000 Benefits Consumer Enjoyment and/or potential Health Benefits II. Table of Commonly Used Acronyms in This Document Table 2—Table of Commonly Used Acronyms Acronym What it means CHD Coronary Heart Disease DASH Dietary Approaches to Stop Hypertension DBP Diastolic Blood Pressure FDA Food and Drug Administration g gram(s) kcal kilocalorie(s) LDL Low-Density Lipoprotein mg milligram(s) NCEP National Cholesterol Education Program NHLBI National Heart, Lung and Blood Institute oz ounces SBP Systolic Blood Pressure SSA Significant Scientific Agreement TC Total Cholesterol III. Background

In the Federal Register of November 10, 1998 (63 FR 62977), and in response to a petition from Protein Technologies International, Inc. (see Docket No. FDA-1998-P-1154), we proposed to provide for health claims on the relationship of soy protein and reduced risk of CHD (hereinafter referred to as the 1998 soy protein proposed rule). In the 1998 soy protein proposed rule, we considered the relevant scientific studies and data presented in the petition as part of our review of the scientific literature on soy protein and CHD. We summarized these studies in table 1 of the soy protein proposed rule (63 FR 62977 at 62998) and presented the rationale for a health claim on this food/disease relationship as provided for under the significant scientific agreement standard in section 403(r)(3)(B)(i) of the FD&C Act and § 101.14(c).

In our 1998 evaluation of the scientific evidence for a relationship between consumption of soy protein and blood total and LDL-cholesterol levels (two validated surrogate endpoints for risk of CHD), we found the data suggestive, but not sufficient, to establish a dose-response for this relationship. However, we found consistent, clinically significant reductions of total- and LDL-cholesterol levels in controlled trials that used at least 25 grams (g) of soy protein per day. Thus, we proposed to base the qualifying level of soy protein on a total daily intake of 25 g, as suggested by the petitioner. For the purposes of health claims, we assumed there are four eating occasions a day (i.e., three main meals and one snack). Therefore, in § 101.82(c)(2)(iii)(A), we proposed the qualifying criterion for a food to bear the claim as 6.25 g of soy protein per reference amount customarily consumed (RACC) (i.e., 25 g divided by four eating occasions per day).

In the Federal Register of October 26, 1999 (64 FR 57700), we authorized a health claim for soy protein and risk of coronary heart disease (21 CFR 101.82). As explained in the final rule, we determined, based on our review of evidence submitted with comments to the proposed rule, as well as evidence described in the proposed rule, that soy protein included in a diet low in saturated fat and cholesterol may reduce the risk of CHD by lowering blood cholesterol levels. FDA's requirements for use of the health claim and model health claim language were codified at 21 CFR 101.82.

FDA evaluates new scientific information that becomes available to determine whether it necessitates a change to an SSA health claim. On December 21, 2007, we published a notice in the Federal Register (72 FR 72738) (the 2007 reevaluation notice) announcing our intent to reevaluate the scientific evidence for certain health claims, including the authorized health claim for soy protein and risk of CHD (§ 101.82). We stated that we were reevaluating the scientific basis for the soy protein and CHD health claim because numerous studies published since we had authorized the health claim had evaluated the relationship between soy protein and CHD, and the findings of these studies were inconsistent from study to study. For example, the Agency for Healthcare Research and Quality (AHRQ) released a report in July 2005 outlining the effects of soy products on health outcomes, including cardiovascular disease, and concluded that soy products appear to exert a small benefit on LDL cholesterol (Ref. 2). However, the AHRQ report included studies that evaluated substances in addition to soy protein (e.g., isolated soy isoflavones). It was not clear from the AHRQ report whether the soy protein, or other components of soy products such as isoflavones, were responsible for lowering LDL cholesterol. In addition, the AHRQ report used markers of cardiac function (e.g., triglycerides, endothelial function, and oxidized low-density lipoprotein) that are not surrogate endpoints recognized by FDA for CHD risk.

Subsequently, we received a citizen petition dated August 8, 2008 (Docket Number FDA-2008-P-0452-001) (hereinafter “the 2008 citizen petition”), requesting that the Commissioner of Food and Drugs revoke § 101.82. On January 4, 2016, we denied the petitioner's request because the limited relevant evidence submitted in the petition and a supplement to the petition did not provide sufficient grounds for us to revoke the soy protein and CHD health claim. However, as noted in the response to the citizen petition, we considered the relevant studies included in the petition as part of our reevaluation.

IV. Legal Authority

The Nutrition Labeling and Education Act of 1990 (NLEA) (Pub. L. 101-535) amended the FD&C Act by, among other things, adding section 403(r) to the FD&C Act. This section specifies, in part, that a food is misbranded if it bears a claim that expressly or by implication characterizes the relationship of a nutrient to a disease or health-related condition unless the claim is made in accordance with section 403(r)(3) of the FD&C Act (for conventional foods) or 403(r)(5)(D) of the FD&C Act (for dietary supplements).

The NLEA also directed FDA to issue regulations authorizing health claims (i.e., labeling claims that characterize the relationship of a nutrient to a disease or health-related condition) for conventional foods if we determine, based upon the totality of publicly available scientific evidence (including evidence from well-designed studies conducted in a manner that is consistent with generally recognized scientific procedures and principles), that there is SSA, among experts qualified by scientific training and experience to evaluate such claims, that the claim is supported by such evidence (see section 403(r)(3)(B)(i) of the FD&C Act). FDA may reevaluate the science related to an authorized health claim and may take action to revoke the claim (see section 403(r)(7)(B) of the FD&C Act (21 U.S.C. 343(r)(7(B)).

Additionally, our regulations, at 21 CFR 10.40(a), provide that we may promulgate regulations necessary to enforce the FD&C Act as appropriate and may initiate such action in any of the ways specified in § 10.25 (21 CFR 10.25). Specifically, § 10.25(b) provides that the Commissioner may initiate a proceeding to revoke a regulation. Accordingly, we are acting within our statutory and regulatory authorities to propose to revoke the authorized health claim for soy protein and a reduced risk of CHD. If this proposed rule is finalized, the use of an authorized health claim would be prohibited and a food that bears the health claim on the label or in labeling would misbrand the food (see section 403(r)(1)(B) of the FD&C Act).

In situations where we determine that the totality of the publicly available scientific evidence does not meet the statutory SSA standard, we may consider whether there is credible evidence to support a “qualified” health claim and what qualifying statements and other information should accompany the claim to ensure that it is truthful and not misleading. If, when we finalize this rule, we conclude there is not SSA, but there is some credible evidence for the use of a qualified health claim about the relationship between soy protein and a reduced risk of CHD, we intend to issue a statement of enforcement discretion for the use of a qualified health claim.

V. Scientific Evidence Regarding the Relationship Between Soy Protein and CHD A. Overview of Data and Eligibility for a Health Claim

Health claims characterize the relationship between a substance and a reduction in risk of contracting a particular disease or developing a health-related condition (Whitaker v. Thompson, 353 F.3d 947, 950-51 (D.C. Cir.) (upholding FDA's interpretation of what constitutes a health claim), cert. denied, 125 S. Ct. 310 (2004)). The substance must be associated with a disease or health-related condition for which the general U.S. population, or an identified U.S. population subgroup, is at risk (§ 101.14(b)(1)). We analyze the information and data related to a health claim under the framework set out in our 2009 guidance titled, “Evidence-Based Review System for the Scientific Evaluation of Health Claims” (Ref. 1). The 2009 guidance discussed our process for evaluating the scientific evidence for a health claim and the meaning of the significant scientific agreement (SSA) standard in section 403(r)(3) of the FD&C Act (21 U.S.C. 343(r)(3)) and 21 CFR 101.14(c). In a review of a health claim, our first step is to identify the substance, the disease or health-related condition that is the subject of the claim, and the population to which the claim is targeted (Ref. 1).

Next, we consider the totality of publicly available data and information to determine whether the scientific evidence could support a relationship between the substance and the disease or health-related condition. We begin this process by organizing the evidence into categories, such as human studies, meta-analyses, review articles, animal studies, and in vitro studies, so we can thoroughly and systematically assess the evidence during the evaluation process. Each category of evidence may offer us helpful information and a better understanding of the topic; however, only well-designed, well-conducted human studies provide both the level of scientific rigor and generalizability to human populations needed to potentially support a health claim relationship. We focus our review on reports of human intervention studies and observational studies. Of the two types of studies, well-conducted intervention studies provide the strongest evidence of an effect and are the most reliable category of studies for determining a cause-and-effect relationship (Ref. 1). In an intervention study, subjects similar to each other are randomly assigned to either receive the intervention or not to receive the intervention, whereas in an observational study, the subjects (or their medical records) are observed for a certain outcome (i.e., disease). Observational studies lack the controlled setting of intervention studies. In contrast to intervention studies, observational studies cannot determine whether an observed relationship represents a relationship in which the substance caused a reduction in disease risk or if other factors or variables may have contributed to an outcome (Ref. 3). In addition to individual reports of human studies, we also consider other types of data and information such as meta-analyses, review articles, and animal and in vitro studies. These other types of data and information may be useful to help us understand the scientific issues about the substance, the disease, or both, but cannot by themselves support a health claim relationship. Reports that discuss a number of different studies, such as meta-analyses and review articles do not provide sufficient information on the individual studies reviewed in order for us to determine critical elements such as the study population characteristics and the composition of the products used. Similarly, the lack of detailed information on studies summarized in review articles and meta-analyses prevents us from determining whether the studies are flawed in critical elements such as design, conduct of studies, and data analysis. We must be able to review the critical elements of a study to determine whether any scientific conclusions can be drawn from it. We use meta-analyses, review articles, and similar publications to identify reports of additional studies that may be useful to the health claim review and as background about the substance-disease relationship. If additional studies are identified, we evaluate them individually.

We use animal and in vitro studies as background information regarding mechanisms of action that might be involved in any relationship between the substance and the disease. In vitro studies are conducted in an artificial environment and cannot account for a multitude of normal physiological processes, such as digestion, absorption, distribution, and metabolism, which affect how humans respond to the consumption of foods and dietary substances (Ref. 4). Further, the physiology of animals is different than that of humans. Animal and in vitro studies can be used to generate hypotheses or to explore a mechanism of action but cannot adequately support a relationship between the substance and the disease.

We evaluate the individual reports of human studies to determine whether any scientific conclusions can be drawn from each study. The absence of critical factors, such as a control group or a statistical analysis, means that scientific conclusions cannot be drawn from the study (Ref. 5-6). Studies from which we cannot draw any scientific conclusions do not support the health claim relationship, and we eliminate such studies from further review.

Because health claims involve reducing the risk of a disease in people who do not already have the disease that is the subject of the claim, we consider evidence from studies in individuals diagnosed with the disease that is the subject of the health claim only if it is scientifically appropriate to extrapolate to individuals who do not have the disease. The available scientific evidence should demonstrate that: (1) The mechanism(s) for the mitigation or treatment effects measured in the diseased populations are the same as the mechanism(s) for risk reduction effects in non-diseased populations; and (2) the substance affects these mechanisms in the same way in both diseased and healthy people. If such evidence is not available, then we cannot draw any scientific conclusions from studies that use diseased subjects to evaluate the substance/disease relationship. Next, we rate the remaining human intervention and observational studies for methodological quality. This quality rating is based on several criteria related to study design (e.g., use of a placebo-control group versus a non-placebo-control group), data collection (e.g., type of dietary assessment method), the quality of the statistical analysis, the type of outcome measured (e.g., disease incidence versus validated surrogate endpoint), and study population characteristics other than relevance to the U.S. population (e.g., age, smoker versus non-smoker) to evaluate factors such as selection bias and whether important information about the study subjects was gathered and reported. For example, if the scientific study adequately addressed all or most of the criteria related to study design, we would assign a high methodological quality rating to the study. We would assign moderate or low quality ratings based on the extent of the deficiencies or uncertainties in the quality criteria. As noted in our guidance (Evidence-Based Review System for the Scientific Evaluation of Health Claims), this quality rating is based on several factors related to study design, data collection, the quality of the statistical analysis, the type of outcome measured, and study population characteristics other than relevance to the U.S. population (e.g., selection bias and the provision of important subject information [e.g., age, smokers]). (Ref. 1). We would not use studies that are so deficient that scientific conclusions cannot be drawn from them to support the health claim relationship, and we eliminate such studies from further review.

We then evaluate the results of the remaining human studies and then rate the overall strength of the total body of publicly available evidence (Ref. 1). We consider the study type (e.g., intervention, prospective cohort, case-control, cross-sectional), the methodological quality rating previously assigned, the quantity of evidence (number of studies of each type and study sample sizes), whether the body of scientific evidence supports a health claim relationship for the U.S. population or target subgroup, whether study results supporting the proposed claim have been replicated (Ref. 7), and the overall consistency (Ref. 8-9) of the total body of evidence (Ref. 1). Based on the totality of the publicly available scientific evidence, we determine whether such evidence meets that SSA standard to support an authorized health claim (also referred to as “SSA health claim”) for the substance/disease relationship. If the evidence does not meet the SSA standard, then we may consider whether such evidence is credible to support a qualified health claim. If there is credible evidence to support a qualified health claim, then we consider what qualifying language should be included to convey the limits on the level of scientific evidence supporting the relationship or to prevent the claim from being misleading in other ways.

B. Reevaluation of the Health Claim for Soy Protein Intake and CHD

In our reevaluation of the scientific evidence for a relationship between soy protein and reduced risk of CHD, we have used the approach outlined in the 2009 guidance to evaluate the totality of the current publicly available scientific evidence regarding this relationship (see section 403(r)(3)(B) of the FD&C Act). In this section, we present our reevaluation of the totality of the publicly available scientific evidence, including the studies we previously reviewed in promulgating the regulation that authorized the 1999 soy protein and CHD health claim (64 FR 57700), as well as studies published after we authorized the health claim in 1999. The 2009 guidance represents FDA's current thinking on the evaluation of health claims as well as the interpretation and meaning of SSA. Because the 1999 final rule predates that guidance, we acknowledge that our reevaluation of studies previously considered in the 1999 rulemaking may differ in certain respects from the previous evaluation. For the purposes of this review, we have identified the following disease endpoints for use in identifying CHD risk reduction for the purposes of a health claim evaluation: The incidence of coronary events (e.g., myocardial infarction, ischemia), cardiovascular death, coronary artery disease, atherosclerosis, and CHD (Ref. 1). We consider high blood pressure, blood (serum or plasma) total cholesterol (TC), and blood LDL cholesterol levels to be surrogate endpoints for CHD risk (Ref. 1). We use these disease and surrogate endpoints to evaluate the potential effects of soy protein on CHD risk.

For the purposes of the reevaluation, we identified a total of 709 publications, drawn from studies included in the 1999 final rule, comments submitted to the 2007 notice of reevaluation, the 2008 citizen petition, and searches of the more recent literature. These publications consisted of 30 in vitro studies; 85 animal studies; 27 government documents; 163 review articles, meta-analyses, letters, abstracts, and books or book chapters; 11 Web sites; 3 articles written in a foreign language; and 141 publications that did not evaluate the substance/disease relationship. The publications also included 11 observational studies that evaluated the substance/disease relationship and 238 publications describing intervention studies that evaluated the relationship between soy protein intake and CHD risk.

1. Assessment of Review Articles, Meta-Analyses, Book Chapters, Letters, and Government Reports

Although useful for background information, review articles, meta-analyses, book chapters, letters, and government reports do not contain sufficient information on the individual studies which they reviewed and, therefore, we could not draw any scientific conclusions from this information. For example, we could not determine factors such as the study population characteristics or the composition of the products used (e.g., food, dietary supplements). Similarly, the lack of detailed information on studies summarized in review articles, meta-analyses, book chapters, letters, and government reports prevents us from determining whether the studies are flawed in critical elements such as design, conduct of studies, and data analysis. We need to be able to review the critical elements of a study to determine whether any scientific conclusions can be drawn from it. As a result, while the review articles, meta-analyses, book chapters, letters, and government reports we identified provided useful background information, they did not provide sufficient information from which scientific conclusions could be drawn regarding soy protein consumption and risk of CHD.

2. Assessment of Animal and In Vitro Studies

We use animal and in vitro studies as background information regarding mechanisms of action that might be involved in any relationship between the substance and the disease; these studies also can be used to generate hypotheses or to explore a mechanism of action, but they cannot adequately support a relationship between a substance and a disease in humans (Ref. 1, 4). Such studies cannot mimic the normal human physiology that may be involved in the risk reduction of CHD, nor can the studies mimic the human body's response to the consumption of soy protein. Therefore, we cannot draw any scientific conclusions from the animal or in vitro studies regarding soy protein and the risk of CHD in humans, and they provide insufficient data to support a health claim. In accordance with these principles, in our review we considered animal and in vitro studies but determined that they did not provide useful supportive information about the relationship between soy protein consumption and risk of CHD.

C. Assessment of Intervention Studies

For the purposes of this review, we categorized the intervention studies based on whether the subjects: (1) Added soy protein to the diet (supplement) in addition to the subjects' usual diet; (2) were instructed to substitute soy protein for animal protein in their diet; and (3) were provided test diets (feeding studies) with soy protein for animal protein (usually casein) in the control diet. In studies where soy proteins were used as a substitute for animal proteins, changes in the total fat, saturated fat, cholesterol, and dietary fiber content of the diet can occur. A reduced intake of total fat (Ref. 10), saturated fat ((Ref. 10), or cholesterol (Ref. 11) has been shown to lower blood cholesterol, and an increased intake of dietary fiber (Ref. 12) has shown the same (Ref. 10), and we have authorized SSA health claims for reduced risk of CHD based on these substance and disease relationships (§ 101.75, § 101.81). Therefore, to determine the independent effect of soy protein intake on blood cholesterol levels, total fat, saturated fat, cholesterol, and dietary fiber need to be controlled for in the studies. Studies that substituted soy protein for animal protein or feeding studies that did not properly control for these nutrients and/or did not report these nutrients were eliminated from further review. For studies in which soy protein was added to the usual diet, the addition of soy protein should not result in significant changes in the total fat, saturated fat, cholesterol, and dietary fiber in the diet (because soy protein does not have significant amounts of these nutrients) (Ref. 13-15). Therefore, we did not eliminate these types of studies that did not control for and/or did not report these nutrients.

To determine the independent effects of soy protein on blood pressure, studies need to control for the amount of sodium and potassium, because both nutrients influence blood pressure (Ref. 16). Studies that substituted soy protein for animal protein or feeding studies where subjects were provided soy protein in test diets that did not properly control for these nutrients and/or did not report these nutrients were eliminated from further review. For studies that added soy protein to the diet, the addition of soy protein should not result in significant changes in the amount of sodium and potassium in the diet; therefore, we did not eliminate these types of studies that did not control for and/or did not report these nutrients (Ref. 13-15). Furthermore, because the nutrients that affect blood pressure (sodium and potassium) and cholesterol (saturated fat, dietary fiber, and cholesterol) are different, some studies might be appropriate for supporting one surrogate endpoint, but not the other. Thus, for the purposes of this assessment, we discuss some studies twice.

Of the 238 total publications describing intervention studies that evaluated the relationship between soy protein intake and CHD risk, 9 publications did not report data on a FDA-recognized surrogate endpoint of CHD risk (i.e., blood total cholesterol, blood LDL cholesterol, blood pressure) (Ref. 17-25). Because these publications did not report data on one or more surrogate endpoints, we could not draw scientific conclusions about the relationship between soy protein consumption and risk of CHD from these studies (Ref. 1).

The remaining 229 publications described 212 intervention studies that evaluated soy protein intake and CHD risk. Of these 212 intervention studies, scientific conclusions could not be drawn from 154 studies due to significant flaws. These studies are discussed in sections V.C. 1. and V.C. 2. Such studies may have other flaws in addition to those specifically mentioned. This left 58 well-designed, well-conducted intervention studies to include in our evaluation of the totality of the publicly available scientific evidence.

1. Intervention Studies That Examined Soy Protein Intake and Blood Cholesterol

As stated previously in this section, we could not draw scientific conclusions about the relationship between soy protein consumption and risk of CHD from 154 intervention studies due to significant design flaws. These studies include 17 studies that did not include a control group or provide an appropriate control for the comparison to the relative effects of soy protein (Ref. 26-42). Without an appropriate control group, we could not determine if the changes in LDL cholesterol were due to soy protein intake or uncontrolled extraneous factors (Ref. 1). Therefore, we could not draw scientific conclusions about the relationship between soy protein consumption and risk of CHD from these studies

Ten studies did not conduct statistical analyses between the control group and treatment group. The statistical analysis of the substance/disease relationship is a critical factor because it provides the comparison between subjects that consumed soy protein and those that did not consume soy protein (i.e., control) to determine whether there is a reduction in CHD risk (Ref. 43-52). Therefore, we could not draw scientific conclusions about the relationship between soy protein consumption and risk of CHD from these studies.

In eight studies (Ref. 53-60), the duration of the study intervention was too short (less than 3 weeks) to adequately determine if changes in serum cholesterol levels were due to the consumption of soy protein (Ref. 1, 61). Therefore, we could not draw scientific conclusions about the relationship between soy protein consumption and risk of CHD from these studies.

Seventy-six studies, described in 84 publications, that substituted soy protein for animal protein or were feeding studies reported large differences in or did not report information on other dietary components that have an effect on blood cholesterol (e.g., dietary fiber, saturated fat, dietary cholesterol) (Ref. 56, 62-145). Such large differences in nutrient intakes of dietary fiber, saturated fat, or dietary cholesterol make it difficult to clearly delineate what may be causing a change in serum cholesterol levels. Therefore, the results of these studies could not be interpreted, and we could not draw scientific conclusions about the relationship between soy protein consumption and risk of CHD from these studies (Ref. 1).

One study, Zittermann et al. (2004) was a randomized, crossover study (Ref. 1) in which 14 German women consumed 5 cookies made with soy flour or 5 cookies made with wheat flour while they remained on their usual diet for one menstrual cycle (30.8 ± 0.9 days). The composition of the test cookies and of the amount of soy protein in the cookies was not adequately described. Furthermore, while the study reported that subjects were to consume the cookies while they remained on their usual diet, the study reported significantly higher intake of dietary fiber (P <0.0001) in the soy period (cookies made with soy flour) than in the control period. When an intervention study involves providing a whole food rather than a food component, the experimental and control diets should be similar enough that the relationship between the substance and disease can be evaluated (Ref. 1). Because the composition of the test cookies were not adequately described, it is not clear why there are differences in dietary fiber intake between the two groups. Thus, we could not draw scientific conclusions about the relationship between soy protein and CHD when the amounts of other substances that are known to affect the risk of CHD (e.g. dietary fiber) are different between the control and experimental diets (Ref. 1, 146).

Nine studies, described in 11 publications that evaluated soy protein intake and blood cholesterol, contained added phytosterols in the treatment group (Ref. 131-132, 147-155). We have an existing regulation for a SSA health claim for the relationship between plant sterol/stanol esters and reduced risk of CHD; however, because plant sterol/stanol esters can reduce blood cholesterol, it is not possible to clearly delineate what may be causing a change in serum cholesterol levels (Ref. 1). Therefore, the results of these studies could not be interpreted, and we could not draw scientific conclusions about the relationship between soy protein consumption and risk of CHD from these studies.

For the remaining 58 intervention studies from which we could draw scientific conclusions, we used the criteria established by the National Heart, Lung and Blood Institute (NHLBI) to sort studies that measured blood cholesterol into 3 categories: (1) Studies that had subjects with desirable or borderline blood cholesterol (TC <240 mg/dL or LDL-cholesterol less than 160 mg/dL); (2) studies that had subjects with high blood cholesterol (TC >240 or LDL cholesterol >160 mg/dL); and (3) studies that had some subjects with desirable or borderline cholesterol level and other subjects with high cholesterol levels (Ref. 156). Additionally, studies that measured blood pressure were sorted based on criteria established by NHLBI into three categories: (1) Normal (Systolic Blood Pressure (SBP) <120 mmHg or Diastolic Blood Pressure (DBP) <80 mmHg); (2) pre-hypertension (SBP 120 to 139 mmHg or DBP 80 to 89 mmHg); and (3) hypertension (SBP ≥140 mmHg or DBP ≥90 mmHg) (Ref. 157-158). Studies were further sorted by whether the studies added (supplemented) soy protein to the diet, were feeding studies, or were substitution studies. Because some studies measured both blood cholesterol and blood pressure, we discussed these studies twice (see tables 4-8 in Ref. 230).

a. Studies in subjects with desirable or borderline cholesterol levels that added isolated soy protein to the diet.

Carmignani et al. (2014) was a 16-week, randomized, double-blind, placebo-controlled, parallel trial of moderate quality in which 40 postmenopausal Brazilian women consumed daily 40 g/day placebo powder of maltrodextrin (n=20) or 40 g/day protein powder containing 24 g/day isolated soy protein (90 mg/day naturally occurring isoflavones) (n=20) in addition to their usual diet (Ref. 159). There was no significant difference in blood TC and LDL cholesterol between the soy protein group and the control group.

Liu et al. (2012) was a 6-month, randomized, double-blind, placebo-controlled, parallel trial of moderate quality in which 120 postmenopausal Chinese women consumed daily 15 g/day milk protein plus 100 mg/day isoflavone supplement (control) (n=60) or 15 g/day isolated soy protein plus 100 mg/day isoflavone supplement (n=60) in addition to their usual diet (Ref. 160). There was no significant difference in the change in blood TC and LDL cholesterol between the milk protein and isoflavone group (control) and the soy protein and isoflavone group.

Santo et al. (2008) was a 28-day, randomized, double-blind, controlled parallel trial of moderate quality in which 30 American men consumed: (1) 25 g/day isoflavone-poor soy protein isolate (1.9 mg/day isoflavones) (n=11); (2) 25 g/day isoflavone-rich soy protein isolate (97 mg/day naturally occurring isoflavones) (n=10); or (3) 25 g/day of milk protein (n=9) (control) mixed with a beverage of their choice in addition to their usual diet (Ref. 161). There were no significant differences in blood TC and LDL cholesterol between the two soy protein isolate treatment groups and the casein control group.

Evans et al. (2007) was a randomized, double-blind, placebo-controlled, crossover trial of moderate quality in which 22 postmenopausal American women consumed: (1) 25 g/day isolated soy protein plus 20 g/day soy lecithin; (2) 25 g/day isolated soy protein plus placebo lecithin; (3) placebo protein (50:50 calcium/sodium caseinate) and 20 g/day soy lecithin; and (4) double placebo (protein placebo and soy lecithin) in addition to their usual diet, for a duration of 4 weeks each (Ref. 162). There was no significant difference in blood TC and LDL cholesterol between the isolated soy protein plus soy lecithin and placebo protein plus soy lecithin treatment period (control). There was also no significant difference in blood TC and LDL between the isolated soy protein plus placebo lecithin and double placebo period (control).

Maesta et al. (2007) was a 16-week, randomized, single-blind, placebo-controlled, parallel trial of moderate quality in which 46 postmenopausal Brazilian women consumed: (1) 25 g/day isolated soy protein (n=10); (2) 25 g/day isolated soy protein, plus resistance exercise (n=14); (3) 25 g/day maltodextrin (control) (n=11); or (4) 25 g/day maltodextrin plus resistance exercise (n=11) (control) in addition to their usual diet (Ref. 163). There was no significant difference in blood TC and LDL cholesterol between the soy protein and control groups.

Kohno et al. (2006) was a two-part, randomized, double-blind, placebo-controlled, parallel trial of moderate quality (Ref. 164). In the first part of the trial, 126 Japanese men and women, in addition to their usual diet, consumed daily 5 g casein (control) (n=61) or 5 g of soybean β-conglycinin (storage protein component of soy protein isolate) in the form of a candy (n=65) for 12 weeks. There was no significant difference between the two diets for blood TC or LDL cholesterol. In the second part of the trial, 95 Japanese men and women consumed daily 5 g casein (n=50) or 5g soybean β-conglycinin (n=45) for 20 weeks. There was no significant difference between the two diets for blood TC or LDL cholesterol.

McVeigh et al. (2006) was a randomized, single-blind, controlled, crossover trial of moderate quality in which 35 Canadian men consumed 32 g/day soy protein isolate depleted of isoflavones (1.64 mg/day), 32 g/day soy protein isolate (62 mg/day isoflavones), or 32 g/day milk protein isolate for a duration of 57 days each (Ref. 165). There was no significant difference between blood TC and LDL cholesterol between the soy protein and casein groups.

Sagara et al. (2004) was a 5-week, randomized, double-blind, placebo-controlled parallel trial of moderate quality in which 50 Scottish men consumed 20 g/day of isolated soy protein powder in biscuits, cereal bars, and bread rolls (n=25) or biscuits, cereal bars, and bread rolls without added soy protein in addition to their usual diets (n=25) (Ref. 166). There was no significant difference in blood TC between the two groups.

Teixeira et al. (2004) was a randomized, controlled, crossover trial of moderate quality in which 14 men American men with type 2 diabetes with nephropathy consumed an estimated 35 g/day of soy protein isolate and casein (control) in addition to their usual diets for a duration of 8 weeks each (Ref. 167). There was no significant difference in blood TC and LDL cholesterol between the soy protein and casein group.

Murray et al. (2003) was a 6-month, randomized, double-blind, placebo-controlled, parallel trial of moderate quality in which 30 American postmenopausal women consumed: (1) 38 g/day soy protein isolate containing (25 g soy protein) plus 1.0 mg estradiol (n=8); (2) 38 g textured milk protein plus 1.0 mg estradiol (n=7) (control); (3) 38 g/day soy protein isolate containing (25 g soy protein) plus 0.5 mg estradiol (n=8); or (4) 38 g/day textured milk protein plus 0.5 mg estradiol(control) (n=7) in addition to their usual diet (Ref. 168). The baseline TC levels in the 38 g/day textured milk protein plus 1.0 mg estradiol group were significantly higher than the (25 g soy protein) plus 1.0 mg estradiol group. If the baseline cholesterol values between groups are significantly different, then it is difficult to determine if differences at the end of the study were due to the intervention or to differences observed at the beginning of the study (Ref. 1). Thus, we could not draw scientific conclusions from this arm of the study. For the soy protein group plus 0.5 mg estradiol and the textured milk protein plus 0.5 mg estradiol (control) groups, the baseline cholesterol levels were similar and conclusions could be drawn. However, there was no significant difference in blood TC and LDL cholesterol between the soy protein group plus 0.5 mg estradiol and the textured milk protein plus 0.5 mg estradiol control group.

Jayagopal et al. (2002) was a randomized, double-blind, placebo-controlled, crossover trial of moderate quality in which 32 postmenopausal British women with type 2 diabetes consumed 30 g/day of isolated soy protein or 30 g/day of cellulose (control) in addition to their usual diet for a duration of 12 weeks each (Ref. 169). Blood TC and LDL cholesterol was significantly lower (P <0.05) in soy protein period compared to the cellulose period.

Higashi et al. (2001) (trial one) was a randomized, controlled, crossover trial of moderate quality in which 14 Japanese men consumed daily milk or yogurt only (no placebo) and 20 g/day soy protein isolate mixed in milk or yogurt in addition to their usual diet for a duration of 4 weeks each (Ref. 26). There was no significant difference in blood TC and LDL cholesterol between the soy protein period and the control period (milk or yogurt only).

Teede et al. (2001) and Dalais et al., (2003) was a 3-month randomized, double-blind, placebo-controlled, parallel trial of moderate quality in which 179 Australian men and postmenopausal women consumed a casein placebo (n=93) or 40 g/day soy protein isolate (n=86) mixed with a beverage twice a day in addition to their usual diet (Ref. 170-171). There was no significant difference in blood TC and LDL cholesterol between the casein control group and soy protein isolate group. In a subgroup analysis of the postmenopausal women (n=55 casein and n=51 soy protein) by Dalais et al. (2003), there was no significant difference in blood TC between the casein control group and soy protein isolate group. However, blood LDL cholesterol was significantly (P <0.05) lower in the soy protein isolate group compared to the casein control group.

Washburn et al. (1999) was a randomized, double-blind, placebo-controlled, crossover trial of moderate quality in which 42 perimenopausal American women consumed daily: (1) 20 g/day complex carbohydrate supplement mixed with a beverage (control); (2) 20 g/day isolated soy protein (34 mg/day naturally occurring phytoestrogens) supplement mixed with a beverage as a single dose; and (3) 20 g/day soy protein supplement (34 mg/day naturally occurring phytoestrogens) mixed with beverages split into two equal doses in addition to their usual diets for 6 weeks each (Ref. 172). Blood TC and LDL cholesterol were significantly (P <0.05) lower in the soy protein groups compared to the control group.

Gooderham et al. (1996) was a 28-day randomized, controlled, parallel trial of moderate quality in which 20 Canadian men consumed daily a supplement containing 60 g/day of soy protein isolate (n=10) or a supplement containing 60 g/day of casein (control) (n=10) in addition to their usual diet (Ref. 173). There was no significant difference in blood TC and LDL cholesterol between the soy protein isolate group and casein group.

b. Studies in subjects with desirable or borderline cholesterol levels that were feeding studies or substitution studies with isolated soy protein.

Mangano et al. (2013) was a 1-year, randomized, double-blind, placebo-controlled, parallel trial of moderate quality in which 97 postmenopausal American women consumed: (1) 18 g/day isolated soy protein plus 105 mg/day isoflavone tablets (n=25); (2) 18 g/day isolated soy protein plus placebo tablets (n=24); (3) 18 g/day control protein (casein, whey, and egg protein) plus 105 mg/day isoflavone tablets (n=26); or (4) control protein and placebo tablets (n=22) in a beverage or food. Subjects were counseled to reduce animal protein foods by approximately 3 oz/day, which is an amount equivalent to the protein powder provided in the study (Ref. 174). There was no significant difference in blood TC or LDL cholesterol between any of the soy protein groups and the control groups.

Steinberg et al. (2003) was a randomized, double-blind, controlled, crossover trial of moderate quality in which 28 postmenopausal American women consumed: (1) 25 g/day of isolated soy protein (107 mg/day naturally occurring isoflavones); (2) 25 g/day of isolated soy protein depleted of isoflavones (2 mg/day isoflavones); and (3) 25 g/day total milk protein (control) for a duration of 6 weeks each (Ref. 175). Subjects mixed the protein powders with a beverage and were instructed to incorporate the protein into their diet without increasing protein or energy intake. There was no significant difference in blood TC and LDL cholesterol between soy protein groups and milk protein control group.

Bakhit et al. (1994) was a randomized, controlled, crossover trial of moderate quality in which 21 American men consumed muffins containing: (1) 25 g/day isolated soy protein plus 20 g/day of dietary fiber from cellulose; (2) 25 g/day isolated soy protein plus 20 g/day of soybean cotyledon fiber; (3) 25 g/day casein plus 20 g/day soybean cotyledon fiber (control); and (4) 25 g/day casein plus 20 g/day of dietary fiber from cellulose (control) for a duration of 4 weeks each (Ref. 176). Subjects were counseled to incorporate the muffins into a low-fat, low-cholesterol diet. There were no significant differences between isolated soy protein groups and control groups for blood TC and LDL cholesterol.

van Raaji et al. (1981) was a 4-week, controlled, parallel trial of moderate quality in which 69 Dutch men and women were fed an average Western diet with different types of dietary protein incorporated into specifically developed products. The dietary protein groups were: (1) 54 g/day of isolated soy protein (n=24); (2) 17 g/day soy (approximately a 2:1 mixture of casein:soy) (n=20); or (3) 55 g/day casein (control) (n=25) (Ref. 177). Participants were matched for initial serum cholesterol, energy intake, and sex. There was no significant difference in blood TC between the isolated soy protein groups and casein control group. However, blood LDL was significantly lower (P <0.05) in the isolated soy protein group compared to the casein control group.

c. Studies in subjects with desirable or borderline cholesterol levels that added soy foods to the diet.

Takatsuka et al. (2000) was a 60-day, randomized, controlled, parallel trial of moderate quality in which 52 premenopausal Japanese women consumed approximately 16 g/day of soy protein from soy milk (n=27) in addition to their usual diet or followed their usual diet as a control diet (n=25) (Ref. 178). The control diet was a usual diet and therefore not a true placebo. The change in blood TC was significantly lower (P = 0.022) in the soy milk group compared to the control group. However, there was no significant difference in the change in blood LDL cholesterol between the two groups.

Mitchell and Collins (1999) was a 4-week, randomized, controlled, parallel trial of moderate quality in which 10 British men consumed: (1) One liter of soy milk (n=4); (2) one liter of rice milk (control) (n=3); or (3) one liter of semi skimmed cow's milk (control) (n=3) in addition to their usual diets. There was no significant difference in blood TC between groups (Ref. 179).

Murkies et al., (1995) was a 12-week randomized, double-blind, controlled parallel trial of moderate quality in which 47 postmenopausal Australian women consumed 45 g/day of wheat flour with an estimated 4.6 g/day wheat protein (control) (n=24) or 45 g/day soy flour with an estimated 15 g/day of soy protein (n=23) in addition to their usual diet (Ref. 180). There was no significant difference in blood TC between the two groups.

d. Studies in subjects with desirable or borderline cholesterol levels that were feeding studies or substitution studies with soy foods.

Matthan et al. (2007) was a randomized, controlled, crossover trial of moderate quality in which 28 American subjects were fed four diets: (1) Animal protein (control), (2) soybean diet (~37.5 g/day soy protein), (3) soy flour (~37.5 g/day soy protein), and (4) and soy milk (~37.5 g/day soy protein) for a duration of 6 weeks each (Ref. 181). Blood LDL cholesterol was significantly lower (P <0.05) in the soymilk diet period compared to the animal protein diet period (control). However, there was no significant difference in blood TC between the soymilk diet period and the animal protein diet period. Furthermore, there was no significant difference in blood TC or LDL cholesterol between the animal protein diet period (control) and the soybean diet period or the soy flour diet period.

Jenkins et al. (1989) was a controlled, crossover trial of moderate quality in which 11 obese Canadian women who consumed a low calorie diet (1,000 kcal) had 2 meals replaced by soy-based liquid formula made from soy flour and soy protein isolate, and a milk-based liquid formula for a duration of 4 weeks each. The soy formula provided approximately 17 g/day soy protein, and the cow's milk formula provided 18 g/day milk protein (control) (Ref. 182). There was no significant difference in blood TC and LDL cholesterol between the soy formula and the cow's milk formula groups.

Bosello et al. (1988) was a 75-day, controlled, parallel trial of moderate quality in which 24 obese Italian subjects were fed a very low calorie diet (375 kcal/day) for 15 days (Ref. 183). The very low calorie diets were then integrated with a commercial textured preparation that provided approximately 27 g/day of casein (control) or approximately 28 g/day soy protein that was consumed daily for 60 days. The 60-day hypocaloric diet provided a total of 800 kcal/day (375 kcal/day from the very low calorie diet and 425 kcal/day from commercial textured preparation). Blood TC and LDL cholesterol was significantly lower (P <0.01) after consuming the soy protein diet compared to the casein diet.

e. Studies that include subjects with normal, borderline, and high cholesterol that were fed or substituted isolated soy protein in the diet.

Greany et al. (2004) was a randomized, controlled, crossover trial of moderate quality in which 33 postmenopausal American women consumed: (1) 26 g/day of soy protein isolate; (2) 26 g/day soy protein isolate plus probiotic capsules; (3) 26 g/day milk protein; and (4) 26 g/day milk protein plus probiotic capsules for a duration of 6 weeks each (Ref. 184). Subjects were counseled to substitute the protein powders in two divided doses for other protein containing foods in their diet. For the analysis, the soy protein and milk protein diets (control), with or without probiotics, were combined. Blood TC and LDL cholesterol was significantly lower (P <0.05) after consuming the soy protein isolate compared to the milk protein control period.

Wong et al. (1998) was a randomized, controlled, crossover trial of high quality in which 13 American subjects with normal or borderline high cholesterol and 13 American subjects with high cholesterol consumed a National Cholesterol Education Program (NCEP) Step 1 soy protein diet that provided approximately 50 g/day isolated soy protein or an NCEP Step 1 animal protein diet that provided approximately 50 g/day animal protein (control) for a duration of 5 weeks each (Ref. 185). Blood LDL cholesterol was significantly lower (P <0.05) after the soy protein period compared to the animal protein period for both the normal and borderline high subjects and high cholesterol subjects. However, there was no significant difference in blood TC between the soy protein diet and the control diet for both the normal and borderline high subjects and high cholesterol subjects.

Goldberg et al. (1982) was a randomized, controlled, crossover trial of moderate quality in which 12 American subjects with high cholesterol and 4 American subjects with normal or borderline high cholesterol consumed daily: (1) An animal protein diet (control); and (2) an isolated soy protein diet for a duration of 6 weeks each. The soy protein diet contained an estimated 99 g/day of isolated soy protein (Ref. 186). Blood TC and LDL cholesterol in the 12 subjects with high cholesterol was significantly lower (P <0.025) after the soy protein diet compared to the animal protein diet. However, there was no significant difference in blood TC and LDL between the two diets in the four subjects with normal or borderline high cholesterol.

f. Studies in subjects with high cholesterol levels that added isolated soy protein to the diet.

Hoie et al. (2007) was an 8-week, randomized, double-blind, placebo-controlled, parallel trial of moderate quality in which 88 German subjects consumed: (1) 25 g/day of isolated soy protein in its native, non-denatured form (n=28); (2) 25 g/day of isolated soy protein (n=32); or (3) 25 g/day of milk protein (derived from caseinate and skimmed milk powder) (n=28) (control) in addition to their usual diets (Ref. 187). Blood TC and LDL cholesterol was significantly lower (P <0.001 and P = 0.002, respectively) after consuming the non-denatured isolated soy protein compared to milk protein group. Blood TC cholesterol was also significantly lower (P = 0.008) after consuming isolated soy protein compared to milk protein group. However, there was no significant difference for blood LDL cholesterol after consuming isolated soy protein compared to milk protein group.

Hoie et al. (2006) was a 4-week, randomized, double-blind, placebo-controlled, parallel trial of moderate quality in which 80 German subjects consumed daily: (1) Ultra-heat-treated chocolate-flavored milk containing 24.4 g/day isolated soy protein and 30.4 g/day milk protein (n=20); (2) 43.3 g/day milk protein (control) (n=20); (3) ultra-heat-treated chocolate flavored milk containing 12.2 g/day isolated soy protein and 15.2 g/day milk protein (n=20); or (4) 21.7 g/day milk protein (control) (n=20) (Ref. 188). There was no significant difference in blood TC or LDL cholesterol between the group that consumed the ultra-heat-treated chocolate-flavored milk containing 24.4 g/day isolated soy protein and 30.4 g/day milk protein group and the control milk protein group. There was also no significant difference in blood TC and LDL cholesterol between the group that consumed ultra-heat-treated chocolate-flavored milk containing 12.2 g/day soy protein and 15.2 g/day milk protein per day (n=20) or the control milk protein group.

Hoie et al. (2005a) was an 8-week, randomized, double-blind, placebo-controlled, parallel trial of moderate quality in which 77 German subjects consumed 25 g/day soy protein (n=39) or 25 g/day milk protein (derived from caseinate and skimmed milk powder) (control) (n=38) in addition to their usual diets (Ref. 189). Blood LDL cholesterol was significantly lower (P <0.05) in the soy protein group when compared to the casein group. There was no difference in blood TC between the soy protein group and casein group.

Hoie et al. (2005b) was an 8-week, randomized, double-blind, placebo-controlled, parallel trial of moderate quality in which 117 German subjects consumed: (1) 25 g/day soy protein (n=39); (2) 15 g/day soy protein plus 10 g/day milk protein (derived from caseinate and skimmed milk powder) (n=39); or (3) 25 g/day milk protein (derived from caseinate and skimmed milk powder) (control) (n=39) in addition to their usual diets (Ref. 190). Blood LDL cholesterol was significantly lower (P = 0.002) after consumption of 25 g/day soy protein compared to the 25 g/day casein group. TC was also significantly lower (P = 0.002) after consumption of 25 g/day soy protein compared to the 25 g/day casein group. In the 15 g/day soy protein plus 10 g/day casein group blood LDL cholesterol was significantly lower (P = 0.011) compared to 25 g/day casein control group. TC was also significantly lower (P = 0.001) after consumption of 15 g/day soy protein plus 10 g/day casein compared to 25 g/day casein control group.

Teede et al. (2005) was a 3-month, randomized, double-blind, placebo-controlled, parallel trial of moderate quality in which 40 postmenopausal Australian women consumed 40 g/day isolated soy protein (n=19) or a casein placebo in addition to their usual diet (n=21) (Ref. 191). There was no significant difference in blood TC or LDL cholesterol between the soy protein and casein group.

Harrison et al. (2004) was a 5-week, randomized, double-blind, placebo-controlled, parallel trial of moderate quality in which 112 British men and women consumed foods (bread, cracker biscuits, and snack bars) that provided 25 g/day isolated soy protein (n=59) or the same foods without soy protein as a control (n=53) in addition to their usual diet (Ref. 192). There was no significant difference in blood TC and LDL cholesterol between the soy protein and control groups.

Blum et al. (2003) was a randomized, double-blind, placebo-controlled, crossover trial of moderate quality in which 24 postmenopausal Israeli women consumed 25 g/day milk protein (control) and 25 g/day isolated soy protein in addition to their usual diets for a duration of 6 weeks each (Ref. 193). Blood TC and LDL cholesterol was significantly lower (P <0.05) after consuming soy protein isolate compared to milk protein period.

Cuevas et al. (2003) was a randomized, double-blind, controlled, crossover trial of moderate quality in which 18 postmenopausal Chilean women consumed diets providing 40 g/day caseinate (control) and 40 g/day isolated soy protein in addition to an NCEP Step 1 diet for a duration of 4 weeks each (Ref. 194). There was no significant difference in blood TC and LDL cholesterol between the caseinate control diet and soy protein diet.

Gardner et al. (2001) was a 12-week, randomized, double-blind, placebo-controlled, parallel trial of moderate quality in which 94 postmenopausal American women consumed: (1) 42 g/day total milk protein (control) (n=30); (2) 42 g/day isolated soy protein with isoflavones depleted (3 mg/day) (n=33); or (3) 42 g/day isolated soy protein (80 mg/day naturally occurring isoflavones) (n=31) in addition to their usual diet (Ref. 195). There was no significant difference in blood TC or LDL cholesterol between the isolated soy protein groups and the total milk protein control group.

Hori et al. (2001) was a 3-month, randomized, double-blind, placebo-controlled, parallel trial of moderate quality in which 21 Taiwanese men consumed: (1) Casein hydrolysate (n=7); (2) 3 g/day of a crude type of soy protein hydrolysate (n=7); or (3) 6 g/day of a crude type of soy protein hydrolysate (n=7) in addition to their usual diet. Blood TC was significantly lower (P <0.05) after consuming 3 g/day of a crude type of soy protein hydrolysate group for 3 months compared to the casein hydrolysate control (Ref. 196). Blood TC was also significantly lower after consuming 6 g/day crude type of soy protein hydrolysate group after 2 and 3 months compared to the casein hydrolysate control. Blood LDL cholesterol was significantly lower (P <0.05) after consuming 3 g/day of a crude type of soy protein hydrolysate group after 2 and 3 months compared to the casein hydrolysate control. Blood LDL cholesterol was also significantly lower (P <0.05) after consuming 6 g/day a crude type of soy protein hydrolysate group after 1, 2, and 3 months compared to the casein hydrolysate group.

g. Studies in subjects with high cholesterol levels that were feeding or substitution studies with isolated soy protein.

Chen et al. (2006) was a 12-week, randomized, double-blind, placebo-controlled, parallel trial of high quality in which 26 Taiwanese subjects on dialysis consumed daily their usual dialysis diet that incorporated 30 g/day milk protein (control) (n=13) or an isolated soy protein diet containing 30 g/day soy protein (n=13) (Ref. 197). Blood TC was significantly lower (P <0.05) in the isolated soy protein diet compared to the milk protein control. There was no significant difference in blood LDL cholesterol between the milk protein control and isolated soy protein diet.

Ma et al. (2005) was a 5-week, randomized, double-blind, controlled, parallel trial of moderate quality in which 159 American subjects consumed daily 28 g/day milk protein supplement (n=78) (control) or a 32 g/day isolated soy protein supplement (n=81) in a beverage. Subjects were counseled to modify their protein and carbohydrate intake to account for the protein supplement intake. There was no significant difference in blood TC and LDL cholesterol between the two diets (Ref. 198).

West et al. (2005) and Hilpert et al. (2005) both discuss a randomized, double-blind, controlled, crossover trial of high quality in which 32 American subjects were fed an NCEP Step 1 diet that incorporated 25 g/day milk protein or 25 g/day soy protein isolate for a duration of 6 weeks each (Ref. 199-200). On each diet, 15 g of the protein supplement was consumed in a muffin while the remaining protein supplement was provided to the subjects to integrate into the meals provided. There was no significant difference in blood TC and LDL cholesterol between the milk protein and soy protein isolate diets.

Jenkins et al. (2002 a and b) was a randomized, single-blind, controlled, crossover trial of moderate quality in which 41 Canadian men and women were fed an NCEP Step 2 diet in which the main protein containing foods were replaced with test foods made with: (1) Approximately 60 g/day dairy and egg protein; (2) 50 g/day of soy protein isolate (10 mg/day naturally occurring isoflavones); and (3) 50 g/day soy protein isolate (73 mg/day naturally occurring isoflavones) for a duration of 1 month each (Ref. 201-202). The percent change in blood TC and LDL cholesterol was significantly lower (P <0.01) after consuming the soy protein diets compared to the dairy and egg protein diet (control).

Lichtenstein et al. (2002) was a randomized, double-blind, controlled, crossover, feeding trial of moderate quality in which 42 American men and women consumed diets of: (1) Isolated soy protein depleted of isoflavones (25 g soy protein/1,000 kcal); (2) isolated soy protein enriched with isoflavones (25 g soy protein plus 50 mg isoflavones/1,000 kcal); (3) animal protein with no added isoflavones (25 g animal protein/1,000 kcal); and (4) animal protein with added isoflavones (25 g animal protein and 50 mg isoflavones/1,000 kcal) for a duration of 6 weeks each (Ref. 203). The mean soy intake for women was 55 g/day and 71 g/day for men. The treatment effects for blood TC and LDL cholesterol were significantly lower (P = 0.017 and P = 0.042, respectively) after consuming the soy protein diets compared to the animal protein diets. For 20 subjects with LCL-C >160 mg/dL, the treatment effects for blood TC and LDL-C were significantly lower (P <0.001 and P = 0.003) after consuming the soy protein diets compared to the animal protein diets. These data were also reported in Wang et al., (2004) and Desroches et al., (2004) (Ref. 204-205).

Van Horn et al. (2001) was a 6-week, randomized, controlled, parallel trial of high quality in which 126 postmenopausal American women consumed an NCEP Step 1 diet in which they isocalorically substituted: (1) Oats and 29 g/day milk protein (n=31) (control); (2) wheat and 29 g/day isolated soy protein (n=31); (3) oats and 29 g/day isolated soy protein (n=31); or (4) wheat and 29 g/day milk protein (n=32) (control) for other carbohydrates and dairy type foods (Ref. 206). There was no significant difference in blood TC or LDL cholesterol between the two control and the two soy protein diets.

h. Studies in subjects with high cholesterol that added soy foods to the diet.

Gardner et al. (2007) was a 4-week, randomized, single-blind, controlled, crossover trial of high quality in which 28 American men and women consumed daily: (1) 1 percent cow's milk (control); (2) whole bean soy milk; and (3) soy protein isolate milk, in addition to an American Heart Association diet (Ref. 207). The whole bean soy milk and the soy protein isolate milk provided 25 g/day of soy protein, and the 1 percent cow's milk provided 25 g/day of milk protein. Blood LDL cholesterol was a significantly lower (P = 0.02) after consuming whole bean soy milk when compared to 1 percent cow's milk. Blood LDL cholesterol was also significantly lower (P = 0.02) after consuming the soy protein diet compared to the 1 percent cow's milk diet.

i. Study in subjects with high cholesterol that were fed soy foods.

Jenkins et al. (2000) was a randomized, controlled, crossover trial of moderate quality in which 25 Canadian men and women consumed daily an NCEP Step 2 diet that incorporated: (1) A commercial breakfast cereal containing 8 g/day wheat protein (control); and (2) a breakfast cereal made with 70 percent soy flour that provided 36 g/day soy protein for a duration of 3 weeks each (Ref. 208). There was no significant difference between the wheat protein cereal (control) period and soy flour cereal diet period for blood TC and LDL cholesterol.

2. Intervention Studies That Examined Soy Protein Intake and Systolic Blood Pressure (SBP) or Diastolic Blood Pressure (DBP)

Twenty-eight studies, described in 30 publications, either substituted soy protein in the diet or were feeding studies. These studies did not control for or provide information on sodium and potassium intake in the diet (Ref. 44, 55, 66, 74, 77, 84, 91, 96-97, 99, 114, 116, 123, 125-126, 131-132, 139-140, 144, 149-151, 153-154, 181, 201-202, 208-209). Because sodium and potassium intake also influence blood pressure, the independent effects of soy protein intake and blood pressure could not be determined. Therefore, we could not draw scientific conclusions about the relationship between soy protein consumption and risk of CHD from these studies.

Four studies did not include an appropriate control protein for a comparison of the relative effects of soy protein (Ref. 40, 42, 210-211). Without an appropriate control group, it cannot be determined if the changes in SBP or DBP were due to soy protein intake or uncontrolled, extraneous factors. Therefore, we could not draw scientific conclusions about the relationship between soy protein consumption and risk of CHD from these studies.

Chiechi et al. (2002) was a 6-month, randomized, parallel trial in which 67 subjects with pre-hypertension (SBP 120 to 139 mmHg or DBP 80 to 89 mmHg) consumed their usual diet (n=43) or their usual diet plus a soy food serving each day (e.g. soy milk, miso soup, tofu, tempeh, or soy beans) (n=34) (Ref. 142). Subjects in the soy group also exchanged two meals twice a week with two meals from a study menu that was based on traditional Mediterranean recipes and soy or soy products. Approximately 50 percent of subjects in the soy group dropped out of the study compared to 20 percent in the control group. Therefore, the dropout rate in the treatment group makes the results of this study difficult to interpret. A high dropout rate can introduce bias because it changed the number of subjects in the treatment group and may also have changed the group's composition compared to the control group. In addition to a high dropout rate, the study had other quality issues (e.g., information on study blinding was not reported, adequate descriptions were not provided for the composition of the background diets or the amount of soy protein in the diets), the study measured biomarkers (SBP or DBP) instead of clinical outcomes (e.g., incidence of CHD). Therefore, this study is so deficient in methodological quality that it is considered to be of low-quality design (Ref. 1) and, as a result, we could not draw scientific conclusions regarding the relationship between soy protein intake and reduced risk of CHD.

a. Studies in subjects with normal or pre-hypertension (SBP <139 mmHg or DBP <89 mmHg).

Anderson et al. (2007) was a 16-week, randomized, single-blind, controlled, parallel trial of moderate quality in which 35 obese American women with pre-hypertension (SBP 120 to 139 mmHg or DBP 80 to 89 mmHg) were fed daily 3 meal replacement shakes containing approximately 22 g/day of casein (control) (n=18) or 21 g/day isolated soy protein (n=17) each (Ref. 89). There was no significant difference in SBP or DBP between the casein and soy protein diet.

Azadbakht et al. (2007) was a randomized, controlled, crossover trial of moderate quality in which 42 postmenopausal Iranian women with pre-hypertension (SBP 120 to 139 mmHg or DBP 80 to 89 mmHg) consumed daily: (1) A Dietary Approaches to Stop Hypertension (DASH) control diet; (2) a 30 g/day soy protein diet; and (3) a 30 g/day soy nut diet for a duration of 8 weeks each (Ref. 65). The soy protein and soy nut diets were the same as the DASH diet with soy protein and soy nuts being substituted for red meat for the control diet. There was no significant difference in SBP or DBP between the DASH control diet and the soy protein and soy nut diets.

Evans et al. (2007) was a randomized, double-blind, placebo-controlled, crossover trial of moderate quality in which 22 pre-hypertensive (SBP 120 to 139 mmHg or DBP 80 to 89 mmHg), postmenopausal American women consumed: (1) 25 g/day isolated soy protein plus 20 g/day soy lecithin; (2) 25 g/day isolated soy protein plus placebo lecithin; (3) placebo protein (50:50 calcium/sodium caseinate) and 20 g/day soy lecithin; and (4) double placebo (protein placebo and soy lecithin) in addition to their usual diet for a duration of 4 weeks each (Ref. 162). There was no significant difference in SBP or DBP between the soy protein plus placebo lecithin group and the double placebo group (control) or between the soy protein plus soy lecithin group and the placebo protein plus soy lecithin period (control).

Harrison et al. (2004) was a 5-week, randomized, double-blind, placebo-controlled, parallel trial of moderate quality in which 112 British men and women with pre-hypertension (SBP 120 to 139 mmHg or DBP 80 to 89 mmHg) consumed foods (bread, cracker biscuits, and snack bars) that provided 25 g/day isolated soy protein (n=59) or the same foods without soy protein as a control (n=53) in addition to their usual diet (Ref. 192). There was no significant difference in SBP and DBP between the soy protein and control groups.

Cuevas et al. (2003) was a randomized, double-blind, controlled, crossover trial of moderate quality in which 18 pre-hypertensive (SBP 120 to 139 mmHg or DBP 80 to 89 mmHg) postmenopausal Chilean women consumed diets providing 40 g/day caseinate (control) or 40 g/day isolated soy protein in addition to an NCEP Step 1 diet for a duration of 4 weeks each (Ref. 194). There was no significant difference in SBP or DBP between the soy protein diet and caseinate control diet.

Teede et al. (2001) was a 3-month randomized, double-blind, placebo-controlled, parallel trial of moderate quality in which 179 pre-hypertensive (SBP 120 to 139 mmHg or DBP 80 to 89 mmHg) Australian men and postmenopausal women consumed a casein placebo (n=93) or 40 g/day soy protein isolate mixed with a beverage twice a day (n=86) in addition to their usual diet (Ref. 170). SBP was significantly lower (P <0.05) in the soy protein isolate group compared to casein control group. However, there was no significant difference in DBP between the casein control group and soy protein isolate group.

Washburn et al. (1999) was a randomized, double-blind, placebo-controlled, crossover trial of moderate quality in which 42 pre-hypertensive (SBP 120 to 139 mmHg or DBP 80 to 89 mmHg), perimenopausal American women consumed: (1) A complex carbohydrate supplement (20 g/day) mixed with a beverage (control); (2) 20 g/day isolated soy protein supplement mixed with a beverage as a single dose; and (3) 20 g/day soy protein supplement mixed with beverages split into two equal doses in addition to their usual diet for a duration of 6 weeks each (Ref. 172). There was no difference in SBP or DBP between the soy protein supplement mixed with a beverage as a single dose period and the complex carbohydrate control period. However, SBP and DBP were significantly lower (P <0.05) after consuming the 20 g/day soy protein supplement mixed with beverages split into two equal doses compared to the complex carbohydrate supplement.

b. Studies in normotensive or pre-hypertensive (SBP <39 mmHg or DBP <89 mmHg) and hypertensive subjects (SBP ≥140 mmHg or DBP ≥90 mmHg).

He et al. (2005) was a 12-week, randomized, double-blind, parallel trial of moderate quality in which 276 Chinese men and women with pre-hypertension (SBP 120 to 139 mmHg or DBP 80 to 89 mmHg) or hypertension (SBP ≥140 mmHg or DBP ≥90 mmHg) consumed cookies containing 40 g/day complex carbohydrates from wheat (n=139) (control) or cookies with 40 g/day isolated soy protein (n=137) (Ref. 212). Subjects were instructed to reduce other food intake to keep total energy intake constant. Most subjects consumed the cookies in place of their usual breakfast or usual lunch. SBP and DBP were significantly (P <0.001) lower for those who consumed the soy protein cookies compared to the wheat cookies (control).

Sagara et al. (2004) was a 5-week randomized, double-blind, placebo-controlled, parallel trial of moderate quality in which 50 Scottish men with pre-hypertension (SBP 120 to 139 mmHg or DBP 80 to 89 mmHg) or hypertension (SBP ≥140 mmHg or DBP ≥90 mmHg) consumed 20 g/day of isolated soy protein powder in biscuits, cereal bars, and bread rolls (n=25) or biscuits, cereal bars, and bread rolls without added soy protein in addition to their usual diets (n=25) (Ref. 166). There was no significant difference in SBP or DBP between the soy protein and control group.

c. Studies in hypertensive subjects (SBP ≥140 mmHg or DBP ≥90 mmHg).

Webb et al. (2008) was a 5-day, randomized, double-blind, placebo-controlled, parallel trial of moderate quality in which 25 hypertensive (SBP ≥140 mmHg or DBP ≥90 mmHg) British men and women with CHD consumed 25.7 g/day soy protein isolate (n=13) or 25.7 g/day milk protein isolate (n=12) in addition to their usual diets (Ref. 60). There was no significant difference in SBP or DBP between the soy protein isolate group and the control milk protein isolate group.

Jayagopal et al. (2002) was a randomized, double-blind, placebo-controlled, crossover trial of moderate quality in which 32 hypertensive (SBP ≥140 mmHg or DBP ≥90 mmHg) postmenopausal British women with type 2 diabetes consumed 30 g/day of isolated soy protein or 30 g/day of cellulose (control) in addition to their usual diet for a duration of 12 weeks each (Ref. 169). There was no significant difference in SBP and DBP between the control diet and the soy protein diet.

Rivas et al. (2002) was a 3-month randomized, double-blind, placebo-controlled, parallel trial of moderate quality in which 40 hypertensive (SBP ≥140 mmHg or DBP ≥90 mmHg) Spanish men and women consumed daily 1 liter of soy milk (18 g/day soy protein) or 1 liter of cow's milk (15.5 g/day protein) in addition to their usual diet (Ref. 213). SBP and DBP was significantly lower (P <0.0001) in the soy milk group compared to the cow's milk group.

D. Assessment of Observational Studies

FDA identified 11 observational studies that evaluated soy protein and CHD risk (Ref. 214-224). All of these observational studies calculated soy protein intake from estimated dietary intake. In observational studies that calculated nutrient intake from conventional foods, measures of soy protein intake were based on recorded dietary intake methods such as food frequency questionnaires, diet recalls, or diet records, in which the type and amount of foods consumed were estimated. A common weakness of observational studies is the limited ability to ascertain the actual food or nutrient intake for the population studied as a result of poor memory, over- or underestimation of portion sizes, and recall bias (Ref. 225). Furthermore, the nutrient content of foods can vary due to a number of factors, including soil composition, food processing and cooking procedures, and storage conditions (e.g., duration, temperature). Thus, we cannot ascertain an accurate amount of soy protein consumed based merely on subjects' reports of dietary intake of foods.

In addition, soy foods contain not only soy protein, but also other nutrients that may be associated with the metabolism of soy protein or the pathogenesis of CHD. Therefore, because soy protein containing foods consist of many nutrients and substances, it is difficult to study the nutrient or food components in isolation (Ref. 3). For studies based on recorded dietary intake of such foods, it is not possible to accurately determine whether any observed effects of soy protein on coronary heart disease risk were due to: (1) Soy protein alone; (2) interactions between soy protein and other nutrients; (3) other nutrients acting alone or together; or (4) decreased consumption of other nutrients or substances contained in foods displaced from the diet by the increased intake of soy protein containing foods. In some instances, epidemiological studies based on the recorded dietary intake of conventional foods may indicate a benefit for a particular nutrient with respect to a disease; however, it is subsequently demonstrated in an intervention study that the nutrient-containing dietary supplement does not confer a benefit or actually increases risk of the disease (Ref. 226). For example, previous epidemiological studies reported an association between fruits and vegetables high in beta-carotene and a reduced risk of lung cancer (Ref. 227). However, subsequent intervention studies, the Alpha-Tocopherol and Beta Carotene Prevention Study (ATBC) and the Carotene and Retinol Efficiency Trial (CARET), demonstrated that beta-carotene supplements increase the risk of lung cancer in smokers and asbestos-exposed workers, respectively (Ref. 228-229). These studies illustrate that the effect of a nutrient provided as a dietary supplement exhibits different health effects compared to when it is consumed as part of a usual diet among many other food components. Furthermore, these studies demonstrate the potential public health risk of relying on results from epidemiological studies in which the effect of a nutrient is based on recorded dietary intake of conventional foods as the sole source for concluding that a relationship exists between a specific nutrient and disease risk (i.e., the effect could actually be harmful).

For the reasons provided in this section, scientific conclusions cannot be drawn from observational studies on foods for soy protein as a food ingredient or component of food.

VI. Strength of the Scientific Evidence

In evaluating the scientific evidence using our evidence-based review system (Ref. 1), we considered the strength of evidence for a relationship between soy protein intake and reduced risk of CHD. When evaluating the strength of the evidence, we consider study types, methodological quality, quantity of evidence for and against the claim (taking into account the numbers of various types of studies and study sample sizes), relevance to the U.S. population or target subgroup, replication of study results supporting the claim, and overall consistency of the evidence (beneficial effect, no effect) (Ref. 1). For the outcome of an intervention study to demonstrate an effect, the validated surrogate or clinical endpoint evaluated in the intervention group should be statistically significantly different from the same validated surrogate or clinical endpoint evaluated in the control group (P <0.05). After assessing the totality of the scientific evidence, we then determine whether there is SSA to support an authorized health claim, or credible evidence to support a qualified health claim.

Our decision about whether to authorize a health claim represents our determination as to whether there is significant scientific agreement among qualified experts that the publicly available scientific evidence supports the substance/disease relationship that is the subject of a proposed health claim. The SSA standard is intended to be a strong standard that provides a high level of confidence in the validity of the substance/disease relationship. SSA occurs well after the stage of emerging science, where data and information permit an inference, but does not require consensus based on unanimous and incontrovertible scientific opinion. We explained in our 2009 guidance (Ref. 1) that we may evaluate new information that becomes available to determine whether it necessitates a change to an existing SSA claim to maximize the public health benefit of our health claims review. The 2009 guidance represents our current thinking on the meaning of the SSA standard in section 403(r)(3) of the FD&C Act and § 101.14(c) and the process for evaluating the scientific evidence for a health claim pursuant to these authorities.

As noted in section V, we reevaluated, consistent with the 2009 guidance (Ref. 1), the studies included in the 1999 final rule as well as new studies that were published since the original review. As discussed in section V.C and D, the totality of the scientific evidence includes 58 well-designed, well-executed intervention studies. Of these 58 studies, 46 are intervention studies of high or moderate quality that measured blood TC or LDL cholesterol, and 12 are intervention studies of high or moderate quality that measured SBP or DBP. The results of these studies were inconsistent and not conclusive.

Of the 46 studies intervention studies of high or moderate quality that measured blood TC or LDL cholesterol, 25 studies were conducted on subjects with desirable or borderline cholesterol levels, defined as a blood TC less than 240 mg/dL or LDL cholesterol less than 160 mg/dL; 18 were conducted on subjects with high TC levels, defined as TC levels less than 240 mg/dL or LDL cholesterol greater than or equal to 160 mg/dL; and 3 studies included subjects with desirable or borderline TC levels and subjects with high TC levels. Of the 46 intervention studies that looked at the relationship between blood TC and/or LCL cholesterol and soy protein intake, only 19 intervention studies showed a benefit in significantly reducing the risk of CHD, while the other 27 intervention studies did not. Study findings also were inconsistent regardless of whether soy protein was added to diet as a supplement or whether the studies were substitution or feeding studies. The study findings also were inconsistent regardless of the study size (10 subjects to 179 subjects) or the dose of soy protein (3 g to 92 g/day). Of the 12 high or moderate quality intervention studies that measured SBP or DBP from which a conclusion could be drawn, only 4 showed a benefit in lowering SBP or DBP with soy protein consumption, while the other 8 studies did not show a benefit. Again, the study findings were inconsistent regardless of baseline SBP or DBP, study size (18 subjects to 276 subjects), or dose (18 g to 60 g/day). Consistency of findings among similar and different study designs is important for evaluating causation and the strength of scientific evidence (Ref. 1). The totality of the evidence does not provide a basis on which experts would find SSA because of the high degree of inconsistency of findings across similar and different studies with high or moderate methodological quality. This degree of inconsistency would not be seen when SSA exists because, when there is SSA, we would find most of the studies to consistently find a beneficial relationship between a substance and a disease risk.

Although there is some evidence that suggests a relationship between soy protein intake and reduced risk of CHD, the strength of the totality of the current, publicly available scientific evidence, discussed in sections V and VI and the references cited therein, which includes many studies that post-date the publication of our 1999 rule, is inconsistent and not conclusive. See also tables 4-8 in Ref. 230. The additional evidence now available to us includes a number of new studies that do not support the relationship, and a number of studies that are inconclusive that also do not support a relationship. This combined body of evidence represents the totality of the scientific evidence that is currently available. We have now evaluated this entire body of evidence, which consists of the studies in the 1999 rule as well as new evidence published since that time, using the evidence based process described in our 2009 guidance. The totality of the evidence, which includes the new, non-supportive studies, does not support the statutory standard for authorizing a health claim. We have determined that the totality of the scientific evidence does not provide significant scientific agreement, among experts qualified by scientific training and experience to evaluate such claims, that the claim is supported. Therefore, we have tentatively concluded that, currently, there is not significant scientific agreement among experts, under section 403(r)(3)(B)(i) of the FD&C Act, that a health claim about a relationship between soy protein intake and CHD risk is supported by the evidence. We request comment and any supporting data and information concerning this tentative conclusion. However, while the totality of the publicly available scientific evidence does not support a finding of SSA, if, when we finalize this rule, we conclude there is not SSA, but there is some credible evidence for the use of a qualified health claim about the relationship between soy protein and a reduced risk of CHD, we intend to issue a statement of enforcement discretion for the use of a qualified health claim.

In the 1999 soy protein final rule authorizing the use of a health claim regarding soy protein and the risk of CHD (64 FR 57700) (now codified at § 101.82) (the 1999 authorized soy protein health claim), the petitioner determined that use of soy as a dietary protein is generally recognized as safe. Under the health claim petition process, we evaluate whether the proponent of the claim demonstrates, to FDA's satisfaction, that the food ingredient is “safe and lawful” under the applicable food safety provisions of the FD&C Act. In the 1999 soy protein final rule, we concluded that there was not sufficient evidence to challenge the petitioner's assertion that soy protein ingredients are GRAS. The petitioner met the showing required by § 101.14(b)(3)(ii) that the substance be “safe and lawful.” We have reviewed the scientific evidence relative to the safety of soy protein as a food ingredient and the evidence does not change our previous conclusion that the use of soy protein at the levels necessary to justify a claim has been demonstrated, to our satisfaction, to be safe and lawful under the applicable food safety provisions of the FD&C Act.

VII. Proposal To Revoke § 101.82

As discussed above, FDA may reevaluate the science related to an authorized health claim and may take action to revoke the claim (see section 403(r)(7)(B) of the FD&C Act (21 U.S.C. 343(r)(7)(B)). Based on our review of the totality of the publicly available scientific evidence, we have tentatively concluded that the SSA standard is not met for a relationship between soy protein and reduced risk of CHD. Therefore, we are proposing to revoke the soy protein and reduced risk of CHD health claim in § 101.82.

VIII. Economic Analysis of Impacts

We have examined the impacts of the proposed rule under Executive Order 12866, Executive Order 13563, Executive Order 13771, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct Agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). Executive Order 13771 requires that the costs associated with new regulations shall “be offset by the elimination of existing costs associated with at least two prior regulations.” It has been determined that this proposed rule is an action that does not impose more than de minimis costs as described below and thus is not a regulatory or deregulatory action for purposes of Executive Order 13771. This proposed rule is a significant regulatory action under Executive Order 12866.

The Regulatory Flexibility Act requires Agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because up to 40 small businesses could be required to relabel one or more products, we find that the proposed rule may have a significant economic impact on a substantial number of small entities.

Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that Agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $148 million, using the most current (2016) Implicit Price Deflator for the Gross Domestic Product. This proposed rule would not result in any year expenditure that meets or exceeds this amount.

The costs of this rule are relabeling the estimated 200 to 300 products currently making the health claim. We estimate total annualized costs of $35,000 to $81,000, when the relabeling costs are annualized over 20 years at a 7-percent discount rate. The initial, one-time costs are $370,000 to $860,000.

The benefit of this rule is better information for the consumers who are considering purchasing products with soy protein. This may generate an unknown amount of increased consumer surplus. Some consumers may react to this new information by switching their consumption to products that they enjoy more, or products that still have an authorized health claim. We request public comment on how many consumers are likely to react to the changes in health claims caused by this proposed rule, and what the nature of their reaction will be. By basing their consumption decisions on more recent and accurate scientific information, they will get more consumer surplus, in the form of enjoyment and/or potential health benefits, from the bundle of products they consume.

Table 3—Cost and Benefit Overview, USD, Annualized Over 20 Years Low estimate Mean High estimate Costs, 7 percent discount rate $35,000 $55,000 $81,000 Costs, 3 percent discount rate 25,000 39,000 58,000 Benefits Consumer Health Benefits and/or Enjoyment

The Economic Analysis of Impacts of the proposed rule performed in accordance with Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act, and the Unfunded Mandates Reform Act is available at https://www.regulations.gov under the docket number for this proposed rule and at: https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

IX. Proposed Effective Date

We intend that the effective date for a final rule resulting from this rulemaking be 30 days after the final rule's date of publication in the Federal Register.

With respect to a compliance date, we intend that any adjustments to a product's labeling occur in a manner consistent with our uniform compliance date (see 81 FR 85156, November 25, 2016). Thus, if we issue a final rule before December 31, 2018, then the compliance date would be January 1, 2020.

X. Analysis of Environmental Impact

We have determined under 21 CFR 25.32(p) that this action, revoking a health claim, is categorically excluded from an environmental assessment or an environmental impact statement.

XI. Paperwork Reduction Act of 1995

FDA tentatively concludes that this proposed rule contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.

XII. Federalism

FDA has analyzed this proposed rule in accordance with the principles set forth in Executive Order 13132. Section 4(a) of the Executive order requires Agencies to “construe * * * a Federal statute to preempt State law only where the statute contains an express preemption provision or there is some other clear evidence that the Congress intended preemption of State law, or where the exercise of State law conflicts with the exercise of Federal authority under the Federal statute.” Federal law includes an express preemption provision that preempts “any requirement respecting any claims of the type described in [21 U.S.C. 343(r)(1)] made in the label or labeling of food that is not identical to the requirement of [21 U.S.C. 343(r)] * * *.” 21 U.S.C. 343-1(a)(5). However, the statutory provision does not preempt any State requirement respecting a statement in the labeling of food that provides for a warning concerning the safety of the food or component of the food (Pub. L. 101-535, section 6, 104 Stat. 2353 (1990)). If this proposed rule is made final, the final rule would revoke the health claim related to soy protein and coronary heart disease in the label or labeling of food under 21 U.S.C. 343(r).

XIII. References

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

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Zittermann A., Geppert J., Baier S., Zehn N., Gouni-Berthold I., Berthold H.K., Reinsberg J., Stehle P. “Short-Term Effects of High Soy Supplementation on Sex Hormones, Bone Markers, and Lipid Parameters in Young Female Adults”. European Journal of Nutrition. 2004;43:100-108. 147. Cicero A.F., Fiorito A., Panourgia M.P., Sangiorgi Z., Gaddi A. “Effects of a New Soy/Beta-Sitosterol Supplement on Plasma Lipids in Moderately Hypercholesterolemic Subjects”. Journal of the Americian Dietetic Association. 2002;102:1807-1811. 148. Cicero A.F., Minardi M., Mirembe S., Pedro E., Gaddi A. “Effects of a New Low Dose Soy Protein/Beta-Sitosterol Association on Plasma Lipid Levels and Oxidation”. European Journal of Nutrition. 2004;43:319-322. 149. Lukaczer D., Liska D.J., Lerman R.H., Darland G., Schiltz B., Tripp M., Bland J.S. “Effect of a Low Glycemic Index Diet with Soy Protein and Phytosterols on Cvd Risk Factors in Postmenopausal Women”. Nutrition. 2006;22:104-113. 150. Jenkins D.J., Kendall C.W., Marchie A., Faulkner D., Vidgen E., Lapsley K.G., Trautwein E.A., Parker T.L., Josse R.G., Leiter L.A., Connelly P.W. “The Effect of Combining Plant Sterols, Soy Protein, Viscous Fibers, and Almonds in Treating Hypercholesterolemia”. Metabolism. 2003;52:1478-1483. 151. Jenkins D.J., Kendall C.W., Marchie A., Faulkner D.A., Wong J.M., de Souza R., Emam A., Parker T.L., Vidgen E., Lapsley K.G., Trautwein E.A., Josse R.G., Leiter L.A., Connelly P.W. “Effects of a Dietary Portfolio of Cholesterol-Lowering Foods Vs Lovastatin on Serum Lipids and C-Reactive Protein”. Journal of the American Medical Association. 2003;290:502-510. 152. Jenkins D.J., Kendall C.W., Faulkner D.A., Nguyen T., Kemp T., Marchie A., Wong J.M., de Souza R., Emam A., Vidgen E., Trautwein E.A., Lapsley K.G., Holmes C., Josse R.G., Leiter L.A., Connelly P.W., Singer W. “Assessment of the Longer-Term Effects of a Dietary Portfolio of Cholesterol-Lowering Foods in Hypercholesterolemia”. 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Cuevas A.M., Irribarra V.L., Castillo O.A., Yanez M.D., Germain A.M. “Isolated Soy Protein Improves Endothelial Function in Postmenopausal Hypercholesterolemic Women”. European Journal of Clinical Nutrition. 2003;57:889-894. 195. Gardner C.D., Newell K.A., Cherin R., Haskell W.L. “The Effect of Soy Protein with or without Isoflavones Relative to Milk Protein on Plasma Lipids in Hypercholesterolemic Postmenopausal Women”. American Journal of Clinical Nutrition. 2001;73:728-735. 196. Hori G., Wang M.F., Chan Y.C., Komatsu T., Wong Y., Chen T.H., Yamamoto K., Nagaoka S., Yamamoto S. “Soy Protein Hydrolyzate with Bound Phospholipids Reduces Serum Cholesterol Levels in Hypercholesterolemic Adult Male Volunteers”. Bioscience, Biotechnology, and Biochemistry. 2001;65:72-78. 197. Chen S.T., Chen J.R., Yang C.S., Peng S.J., Ferng S.H. “Effect of Soya Protein on Serum Lipid Profile and Lipoprotein Concentrations in Patients Undergoing Hypercholesterolaemic Haemodialysis”. British Journal of Nutrition. 2006;95:366-371. 198. Ma Y., Chiriboga D., Olendzki B.C., Nicolosi R., Merriam P.A., Ockene I.S. “Effect of Soy Protein Containing Isoflavones on Blood Lipids in Moderately Hypercholesterolemic Adults: A Randomized Controlled Trial”. Journal of the American College of Nutrition. 2005;24:275-285. 199. West S.G., Hilpert K.F., Juturu V., Bordi P.L., Lampe J.W., Mousa S.A., Kris-Etherton P.M. “Effects of Including Soy Protein in a Blood Cholesterol-Lowering Diet on Markers of Cardiac Risk in Men and in Postmenopausal Women with and without Hormone Replacement Therapy”. Journal of Womens Health. 2005;14:253-262. 200. Hilpert K.F., Kris-Etherton P.M., West S.G. “Lipid Response to a Low-Fat Diet with or without Soy Is Modified by C-Reactive Protein Status in Moderately Hypercholesterolemic Adults”. Journal of Nutrition. 2005;135:1075-1079. 201. Jenkins D.J., Kendall C.W., Jackson C.J., Connelly P.W., Parker T., Faulkner D., Vidgen E., Cunnane S.C., Leiter L.A., Josse R.G. “Effects of High- and Low-Isoflavone Soyfoods on Blood Lipids, Oxidized Ldl, Homocysteine, and Blood Pressure in Hyperlipidemic Men and Women”. American Journal of Clinical Nutrition. 2002;76:365-372. 202. Jenkins D.J., Kendall C.W., Connelly P.W., Jackson C.J., Parker T., Faulkner D., Vidgen E. “Effects of High- and Low-Isoflavone (Phytoestrogen) Soy Foods on Inflammatory Biomarkers and Proinflammatory Cytokines in Middle-Aged Men and Women”. Metabolism. 2002;51:919-924. 203. Lichtenstein A.H., Jalbert S.M., Adlercreutz H., Goldin B.R., Rasmussen H., Schaefer E.J., Ausman L.M. “Lipoprotein Response to Diets High in Soy or Animal Protein with and without Isoflavones in Moderately Hypercholesterolemic Subjects”. Arteriosclerosis, Thrombosis, and Vascular Biology. 2002;22:1852-1858. 204. Wang Y., Jones P.J., Ausman L.M., Lichtenstein A.H. “Soy Protein Reduces Triglyceride Levels and Triglyceride Fatty Acid Fractional Synthesis Rate in Hypercholesterolemic Subjects”. Atherosclerosis. 2004;173:269-275. 205. Desroches S., Mauger J.F., Ausman L.M., Lichtenstein A.H., Lamarche B. “Soy Protein Favorably Affects Ldl Size Independently of Isoflavones in Hypercholesterolemic Men and Women”. Journal of Nutrition. 2004;134:574-579. 206. Van H.L., Liu K., Gerber J., Garside D., Schiffer L., Gernhofer N., Greenland P. “Oats and Soy in Lipid-Lowering Diets for Women with Hypercholesterolemia: Is There Synergy?”. Journal of the American Dietetic Association. 2001;101:1319-1325. 207. Gardner C.D., Messina M., Kiazand A., Morris J.L., Franke A.A. “Effect of Two Types of Soy Milk and Dairy Milk on Plasma Lipids in Hypercholesterolemic Adults: A Randomized Trial”. Journal of the American College of Nutrition. 2007;26:669-677. 208. Jenkins D.J., Kendall C.W., Vidgen E., Vuksan V., Jackson C.J., Augustin L.S., Lee B., Garsetti M., Agarwal S., Rao A.V., Cagampang G.B., Fulgoni V., III. “Effect of Soy-Based Breakfast Cereal on Blood Lipids and Oxidized Low-Density Lipoprotein”. Metabolism. 2000;49:1496-1500. 209. Teede H.J., Giannopoulos D., Dalais F.S., Hodgson J., McGrath B.P. “Randomised, Controlled, Cross-over Trial of Soy Protein with Isoflavones on Blood Pressure and Arterial Function in Hypertensive Subjects”. Journal of the American College of Nutrition. 2006;25:533-540. 210. Burke V., Hodgson J.M., Beilin L.J., Giangiulioi N., Rogers P., Puddey I.B. “Dietary Protein and Soluble Fiber Reduce Ambulatory Blood Pressure in Treated Hypertensives”. Hypertension. 2001;38:821-826. 211. Jenkins D.J., Kendall C.W., Faulkner D.A., Kemp T., Marchie A., Nguyen T.H., Wong J.M., de Souza R., Emam A., Vidgen E., Trautwein E.A., Lapsley K.G., Josse R.G., Leiter L.A., Singer W. “Long-Term Effects of a Plant-Based Dietary Portfolio of Cholesterol-Lowering Foods on Blood Pressure”. European Journal of Clinical Nutrition. 2008;62:781-788. 212. He J., Gu D., Wu X., Chen J., Duan X., Chen J., Whelton P.K. “Effect of Soybean Protein on Blood Pressure: A Randomized, Controlled Trial”. Annals of Internal Medicine. 2005;143:1-9. 213. Rivas M., Garay R.P., Escanero J.F., Cia P., Jr., Cia P., Alda J.O. “Soy Milk Lowers Blood Pressure in Men and Women with Mild to Moderate Essential Hypertension”. Journal of Nutrition. 2002;132:1900-1902. 214. Chan Y.H., Lau K.K., Yiu K.H., Li S.W., Chan H.T., Tam S., Shu X.O., Lau C.P., Tse H.F. “Isoflavone Intake in Persons at High Risk of Cardiovascular Events: Implications for Vascular Endothelial Function and the Carotid Atherosclerotic Burden”. 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Food labeling, Nutrition, Reporting and recordkeeping requirements.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, it is proposed that 21 CFR part 101 be amended as follows:

PART 101—FOOD LABELING 1. The authority citation for part 101 continues to read as follows: Authority:

15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342, 343, 348, 371; 42 U.S.C. 243, 264, 271.

§ 101.82 [Removed]
2. Remove § 101.82. Dated: October 26, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-23629 Filed 10-30-17; 8:45 am] BILLING CODE 4164-01-P
POSTAL SERVICE 39 CFR Part 111 eInduction Option, Seamless Acceptance Program, and Full-Service Automation Option, Verification Standards AGENCY:

Postal ServiceTM.

ACTION:

Proposed rule.

SUMMARY:

The Postal Service is proposing to amend Mailing Standards of the United States Postal Service, Domestic Mail Manual (DMM®), sections 705.20, eInduction Option, 705.22, Seamless Acceptance Program, and 705.23, Full-Service Automation Option, to add the verification standards.

DATES:

Submit comments on or before November 30, 2017.

ADDRESSES:

Mail or deliver written comments to the manager, Product Classification, U.S. Postal Service, 475 L'Enfant Plaza SW., Room 4446, Washington, DC 20260-5015. If sending comments by email, include the name and address of the commenter and send to [email protected], with a subject line of “Verification Standards”. Faxed comments are not accepted. You may inspect and photocopy all written comments, by appointment only, at USPS® Headquarters Library, 475 L'Enfant Plaza SW., 11th Floor North, Washington, DC 20260. These records are available for review on Monday through Friday, 9 a.m.-4 p.m., by calling 202-268-2906.

FOR FURTHER INFORMATION CONTACT:

Heather Dyer at (207) 482-7217, or Garry Rodriguez at (202) 268-7281.

SUPPLEMENTARY INFORMATION:

The Postal Service is proposing to amend DMM sections 705.20, eInduction Option, 705.22, Seamless Acceptance Program, and 705.23, Full-Service Automation Option, to add the applicable verification descriptions, error thresholds, and postage assessments, standards. These standards have been made available to the public via Publication 6850, Publication for Streamlined Mail Acceptance for Letters and Flats, available at https://postalpro.usps.com, which also contains additional information on the verification processes.

List of Subjects in 39 CFR Part 111

Administrative practice and procedure, Postal Service.

Although we are exempt from the notice and comment requirements of the Administrative Procedure Act (5 U.S.C. 553(b), (c)) regarding proposed rulemaking by 39 U.S.C. 410(a), we invite public comments on the following proposed revisions to Mailing Standards of the United States Postal Service, Domestic Mail Manual (DMM), incorporated by reference in the Code of Federal Regulations. See 39 CFR 111.1. Accordingly, 39 CFR part 111 is proposed to be amended as follows:

PART 111—[AMENDED] 1. The authority citation for 39 CFR part 111 continues to read as follows: Authority:

5 U.S.C. 552(a); 13 U.S.C. 301-307; 18 U.S.C. 1692-1737; 39 U.S.C. 101, 401, 403, 404, 414, 416, 3001-3011, 3201-3219, 3403-3406, 3621, 3622, 3626, 3632, 3633, and 5001.

2. Revise the following sections of Mailing Standards of the United States Postal Service, Domestic Mail Manual (DMM), as follows: Mailing Standards of the United States Postal Service, Domestic Mail Manual (DMM) 700 Special Standards 705 Advanced Preparation and Special Postage Payment Systems 705.20.0 eInduction Option 20.1 Description

[Revise the fourth sentence of 20.1 to read as follows:]

* * * For additional information on the eInduction Option see Publication 6850, Publication for Streamlined Mail Acceptance for Letters and Flats, available at https://postalpro.usps.com.

[Add new subsection 20.5, Verifications, to read as follows:]

20.5 Verifications

The six eInduction option verification descriptions, error thresholds, and postage assessments, are provided in 20.5.1 through 20.5.6.

20.5.1 Undocumented (Extra) Containers Verification

An Undocumented Container error occurs when a scanned IMcb is not found in an eDoc, or is included in an eDoc and associated to a postage statement in estimated (EST) status. Containers will be flagged as Undocumented 10 days after the scan unload date/time if no eDoc has been uploaded or if the postage statement is still in EST status. The threshold is 0%. All errors will be subject to an assessment amount of the average postage paid for each container mailed by the eDoc submitter CRID over the current invoice period to the eDoc submitter CRID or CRID tied to the MID contained within the IMcb.

20.5.2 Payment Verification

All containers must be linked to a finalized postage statement in eInduction to verify payment. The error threshold is 0%. Payment verification errors are logged when a scanned and accepted eInduction container is associated with a postage statement that is not in FIN or FPP status at the time of scanning. Containers above the error threshold will be subject to an assessment amount equal to the containers eDoc postage amount as indicated on the non-finalized postage statements. For payment errors logged on physical siblings of logical containers, the full postage of the logical container is charged to the first physical sibling container scanned. Any additional scans among other physical siblings will log errors, but will not result in an additional charge. Assessments will be logged against the eDoc submitter CRID.

20.5.3 Duplicate Verification

eInduction requires IMcbs to remain unique for 45 days. The error threshold is 0.17%. Duplicate errors are logged when an IMcb is scanned and accepted during more than one FAST appointment in the previous 45 days. Though a duplicate error will not be logged if the duplicate scan takes place within 5 hours of the original scan. Errors above the threshold are subject to an assessment amount equal to the average postage paid for each container mailed by the eDoc submitter CRID over the invoice period.

20.5.4 Misshipped Verification

Containers claiming a destination entry discount must be delivered to the correct entry locations per the active version of the Mail Direction File. The error threshold is 1.05%. Misshipped errors are logged when the container is scanned at an incorrect entry location, per the Mail Direction File. Errors over the threshold are subject to an assessment amount equal to the difference between the eDoc postage claimed, and the correct postage amount for the container. For misshipped errors logged against physical siblings of logical containers, postage is recalculated on the logical container, and divided by the number of physical siblings. This amount is then applied to each physical sibling in error to the eDoc submitter CRID.

20.5.5 Zone Discount Verification

Pieces claiming a Zone Discount must be entered at the valid facility. The error threshold is 0.01%. Zone Discount errors are logged when the Zone Discount claimed in the eDoc is a lower entry zone than the zone calculated between the location where the container was entered, and the eDoc destination. Errors above the threshold are subject to an assessment amount equal to the difference between the eDoc postage claimed, and the correct postage amount for the container. For containers claiming a non-numeric Zone Discount in the eDoc, correct postage amount is calculated using the piece rate for the Entry Discount that is valid at the actual entry point for the mail class, shape, weight, mail prep, and presort identified in the eDoc. For Zone Discount errors logged against physical siblings of logical containers, postage is recalculated on the logical container, and divided by the number of physical siblings. This amount is then applied to each physical sibling in error to the eDoc submitter CRID.

20.5.6 Entry Point Discount (EPD) Verification

eInduction pieces are required to be entered at a valid facility when claiming a destination entry discount. The error threshold is 0.5%. EPD errors are logged when one or more pieces on a container claim an entry discount level that is not available at the location where the container was entered. Errors above threshold are subject to an assessment amount equal to the difference between the eDoc postage claimed and the correct postage amount for the container. For EPD errors logged against physical siblings of logical containers, postage is recalculated on the logical container, and divided by the number of physical siblings. This amount is then applied to each physical sibling in error to the eDoc submitter CRID.

705.22.0 Seamless Acceptance Program 22.1 Description

[Revise the second sentence of 22.1 to read as follows:]

* * * For additional information, on the Seamless Acceptance Program see Publication 6850, Publication for Streamlined Mail Acceptance for Letters and Flats, available at https://postalpro.usps.com.

[Add new subsection 22.4, Verifications, to read as follows:]

22.4 Verifications

The five seamless acceptance program verification descriptions, error thresholds, and postage assessments, are provided in 22.4.1 through 22.4.5.

22.4.1 Undocumented (Piece) Verification

An Undocumented error is logged when the IMb gathered during sampling or MPE scan cannot be linked to any eDoc submitted within the last 45 days. The error threshold is 0.3%. Pieces above the error threshold will be subject to an assessment amount equal to the average piece rate by mail class and CRID for the assessment month.

22.4.2 Delivery Point Verification

A valid delivery point must be provided in the piece IMb. The error threshold is 2%. Delivery Point errors are logged when the delivery point provided in the eDoc is either not valid, or contains a generic +4 information with an address record type that is not General Delivery. Errors above the threshold are subject to an assessment amount equal to difference between the eDoc piece postage and correct postage amount.

22.4.3 Nesting/Sortation (MPE) Verification

A Nesting/Sortation error is logged when the piece scanned is nested in a different tray or bundle than the tray or bundle that was identified in the eDoc. The error threshold is 1%. Errors above this threshold are subject to an assessment amount equal to the difference between the eDoc piece postage and the correct postage amount.

22.4.4 General Postage Adjustment Factor Verification

The Postage Adjustment Factor (PAF) is a method to apply an error rate determined from handheld scanner samplings to the entire population of mailings within a calendar month. PAF is calculated on a monthly basis and measures the difference between the correct postage and the postage paid, expressed as a ratio of the correct postage due to the sum of eDoc postage for the sampled pieces. General PAF is used for errors in postage and weight verifications. The General PAF threshold is 1.05. A mailer will only be subject to an assessment when the eDoc submitter has exceeded the PAF threshold in the current billing month and three or more times in the previous 11 billing months. The General PAF is applied to the total monthly eDoc postage for the eDoc submitter and assessments are issued to the eDoc submitter.

22.4.5 Mail Characteristic Postage Adjustment Factor Verification

The Mail Characteristic, Postage Adjustment Factor (PAF), is used for errors in the processing category, mail class, nonprofit eligibility and content. The threshold is 1.05. A mailer will only be subject to an assessment when the eDoc submitter has exceeded the Mail Characteristic PAF threshold in the current billing month and three or more times in the previous 11 billing months. The Mail Characteristic PAF is applied at the eDoc Submitter CRID level and is calculated using the adjusted and eDoc postage attributed to the Mail Owner.

705.23.0 Full-Service Automation Option 23.1 Description

[Revise the second sentence of 23.1 to read as follows:]

* * * For additional information on the full-service automation option see Publication 6850, Publication for Streamlined Mail Acceptance for Letters and Flats, available on PostalPro at http://postalpro.usps.com.

[Add new subsection 23.6, Verifications, to read as follows:]

23.6 Verifications

The six full-service verification descriptions, error thresholds, and postage assessments, are provided in 23.6.1 through 23.6.6.

23.6.1 Mailer Identification (MID) Verification

The MID is a code used for identification of mail's responsible party. A valid MID is one that is registered within the Postal Service systems and provided in the eDoc. The error threshold is 2%. Errors over the threshold will be subject to an assessment amount equal to the removal of the full-service discount claimed for each piece in error above the threshold.

23.6.2 Service Type ID (STID) Verification

The STID is a three-digit code included in the IMb for a mailpiece to provide mail class and service level. The error threshold is 2%. Errors over the threshold will be subject to an assessment amount equal to the removal of the full-service discount claimed for each piece in error above the threshold.

23.6.3 By/For Verification

The By/For relationship recognizes the Mail Owner and Mail Service Provider in the eDoc. The error threshold is 5%. An error occurs when a valid Mail Preparer is not identified, a valid Mail Owner is not identified, Mail Preparer is incorrectly recorded as the Mail Owner, or the Mail Owner is incorrectly identified as the Mail Preparer. Errors above the threshold are subject to an assessment amount equal to the removal of the full-service discount claimed for each piece in error above the threshold.

23.6.4 Barcode Uniqueness Verification

Barcode uniqueness is met when a barcode is unique across all mailers and mailings for 45 days. The error threshold is 2%. Errors occur when the IMcb, IMtb or IMb is not unique across all mailings from all mailers over the previous 45 days of the postage statement mailing date that was provided in the eDoc. Errors above the threshold are subject to an assessment equal to the removal of the full-service discount claimed for each piece in error above the threshold.

23.6.5 Entry Facility Verification

The entry facility location must be identified in the eDoc by a Locale Key or ZIP Code. The error threshold is 2%. Errors above the threshold are subject to an assessment amount of the full-service discount claimed for each piece in error above the threshold.

23.6.6 Unlinked Copal Verification

Mailings that will be copalletized must be identified in the original eDoc submission and properly documented within 14 days of the mailing date to link trays or sacks to the container. The error threshold is 5%. Errors above the threshold are subject to an assessment amount equal to the full-service discount claimed.

If the proposal is adopted, we will publish an appropriate amendment to 39 CFR part 111 to reflect these changes.

Stanley F. Mires, Attorney, Federal Compliance.
[FR Doc. 2017-23615 Filed 10-30-17; 8:45 am] BILLING CODE 7710-12-P
ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 261 [EPA-R06-RCRA-2017-0556; FRL-9970-10-Region 6] Hazardous Waste Management System; Identification and Listing of Hazardous Waste AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Proposed rule.

SUMMARY:

The Environmental Protection Agency (EPA) is proposing to grant a petition submitted by Blanchard Refining Company LLC—(Blanchard) to exclude (or delist) the residual solids generated from the reclamation of oil bearing hazardous secondary materials (OBSMs) on-site at Blanchard's Galveston Bay Refinery (GBR), located in Texas City, Texas from the lists of hazardous wastes. EPA used the Delisting Risk Assessment Software (DRAS) Version 3.0.35 in the evaluation of the impact of the petitioned waste on human health and the environment.

DATES:

We will accept comments until November 30, 2017. We will stamp comments received after the close of the comment period as late. These late comments may or may not be considered in formulating a final decision. Your requests for a hearing must reach EPA by November 15, 2017. The request must contain the information prescribed in 40 CFR 260.20(d) (hereinafter all CFR cites refer to 40 CFR unless otherwise stated).

ADDRESSES:

Submit your comments, identified by Docket ID No. EPA-R06-RCRA-2017-0556, at http://www.regulations.gov. Follow the online instructions for submitting comments. Once submitted, comments cannot be edited or removed from Regulations.gov. The EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission (i.e. on the web, cloud, or other file sharing system). For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit https://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT:

For technical information regarding the Blanchard Refinery petition, contact Michelle Peace at 214-665-7430 or by email at [email protected]

Your requests for a hearing must reach EPA by November 15, 2017. The request must contain the information described in 40 CFR 260.20(d).

SUPPLEMENTARY INFORMATION:

Blanchard submitted a petition under 40 CFR 260.20 and 260.22(a). Section 260.20 allows any person to petition the Administrator to modify or revoke any provision of parts 260 through 266, 268 and 273. Section 260.22(a) specifically provides generators the opportunity to petition the Administrator to exclude a waste on a “generator specific” basis from the hazardous waste lists. EPA bases its proposed decision to grant the petition on an evaluation of waste-specific information provided by the petitioner. This decision, if finalized, would conditionally exclude the petitioned waste from the requirements of hazardous waste regulations under the Resource Conservation and Recovery Act (RCRA).

If finalized, EPA would conclude that Blanchard's petitioned waste is non-hazardous with respect to the original listing criteria. EPA would also conclude that Blanchard's reclamation process minimizes short-term and long-term threats from the petitioned waste to human health and the environment.

Table of Contents

The information in this section is organized as follows:

I. Overview Information A. What action is EPA proposing? B. Why is EPA proposing to approve this delisting? C. How will Blanchard manage the waste if it is delisted? D. When would the proposed delisting exclusion be finalized? E. How would this action affect the states? II. Background A. What is the history of the delisting program? B. What is a delisting petition, and what does it require of a petitioner? C. What factors must EPA consider in deciding whether to grant a delisting petition? III. EPA's Evaluation of the Waste Information and Data A. What wastes did Blanchard petition EPA to delist? B. Who is Blanchard and what process does it use to generate the petitioned waste? C. How did Blanchard sample and analyze the data in this petition? D. What were the results of Blanchard's sample analysis? E. How did EPA evaluate the risk of delisting this waste? F. What did EPA conclude about Blanchard's analysis? G. What other factors did EPA consider in its evaluation? H. What is EPA's evaluation of this delisting petition? IV. Next Steps A. With what conditions must the petitioner comply? B. What happens if Blanchard violates the terms and conditions? V. Public Comments A. How can I as an interested party submit comments? B. How may I review the docket or obtain copies of the proposed exclusions? VI. Statutory and Executive Order Reviews
I. Overview Information A. What action is EPA proposing?

EPA is proposing to approve the delisting petition submitted by Blanchard to have the residual solids excluded, or delisted from the definition of a hazardous waste. The residual solids are listed as F037. Blanchard's residual solids are listed as a hazardous waste, based on the potential presence of Appendix VII inorganic constituents of concern, lead and chromium, and Appendix VII organic constituents of concern benzene, benzo(a)pyrene and chrysene.

B. Why is EPA proposing to approve this delisting?

Blanchard's petition requests an exclusion from the F037 waste listing pursuant to 40 CFR 260.20 and 260.22. Blanchard does not believe that the petitioned waste meets the criteria for which EPA listed it. Blanchard also believes no additional constituents or factors could cause the waste to be hazardous. EPA's review of this petition included consideration of the original listing criteria and the additional factors required by the Hazardous and Solid Waste Amendments of 1984 (HSWA). See section 3001(f) of RCRA, 42 U.S.C. 6921(f), and 40 CFR 260.22 (d)(1)-(4) (hereinafter all sectional references are to 40 CFR unless otherwise indicated). In making the initial delisting determination, EPA evaluated the petitioned waste against the listing criteria and factors cited in §§ 261.11(a)(2) and (a)(3). Based on this review, EPA agrees with the petitioner that the waste is non-hazardous with respect to the original listing criteria. If EPA had found, based on this review, that the waste remained hazardous based on the factors for which the waste was originally listed, EPA would have proposed to deny the petition. EPA evaluated the waste with respect to other factors or criteria to assess whether there is a reasonable basis to believe that such additional factors could cause the waste to be hazardous. EPA considered whether the waste is acutely toxic, the concentration of the constituents in the waste, their tendency to migrate and to bioaccumulate, their persistence in the environment once released from the waste, plausible and specific types of management of the petitioned waste, the quantities of waste generated, and waste variability. EPA believes that the petitioned waste does not meet the listing criteria and thus should not be a listed waste. EPA's proposed decision to delist waste from Blanchard is based on the information submitted in support of this rule, including descriptions of the wastes and analytical data resulting from Blanchard's delisting demonstration conducted on the petitioned waste.

C. How will Blanchard manage the waste if it is delisted?

If the residual solids are delisted, contingent upon approval of the delisting petition, storage containers with Blanchard's delisted residual solids will be transported to an authorized, solid waste landfill (e.g. RCRA Subtitle D landfill, commercial/industrial solid waste landfill, etc.) for disposal. Any plans for recycling must be addressed through the Hazardous Waste Recycling regulations.

D. When would the proposed delisting exclusion be finalized?

RCRA section 3001(f) specifically requires EPA to provide a notice and an opportunity for comment before granting or denying a final exclusion. Thus, EPA will not grant the exclusion until it addresses all timely public comments (including those at public hearings, if any) on this proposal.

RCRA section 3010(b)(1) at 42 USCA 6930(b)(1), allows rules to become effective in less than six months when the regulated facility does not need the six-month period to come into compliance. That is the case here, because this rule, if finalized, would reduce the existing requirements for persons generating hazardous wastes.

EPA believes that this exclusion should be effective immediately upon final publication because a six-month deadline is not necessary to achieve the purpose of section 3010(b), and a later effective date would impose unnecessary hardship and expense on this petitioner. These reasons also provide good cause for making this rule effective immediately, upon final publication, under the Administrative Procedure Act, 5 U.S.C. 553(d).

E. How would this action affect the states?

Because EPA is issuing this exclusion under the Federal RCRA delisting program, only states subject to Federal RCRA delisting provisions would be affected. This would exclude states which have received authorization from EPA to make their own delisting decisions.

EPA allows states to impose their own non-RCRA regulatory requirements that are more stringent than EPA's, under section 3009 of RCRA, 42 U.S.C. 6929. These more stringent requirements may include a provision that prohibits a Federally issued exclusion from taking effect in the state. Because a dual system (that is, both Federal (RCRA) and state (non-RCRA) programs) may regulate a petitioner's waste, EPA urges petitioners to contact the state regulatory authority to establish the status of their wastes under the state law.

EPA has also authorized some states (for example, Louisiana, Oklahoma, Georgia, Illinois) to administer a RCRA delisting program in place of the Federal program, that is, to make state delisting decisions. Therefore, this exclusion does not apply in those authorized states unless that state makes the rule part of its authorized program. If Blanchard transports the delisted waste to or manages the delisted waste in any state with delisting authorization, Blanchard must obtain delisting authorization from that state before it can manage the delisted waste as non-hazardous in the state.

II. Background A. What is the history of the delisting program?

EPA published an amended list of hazardous wastes from non-specific and specific sources on January 16, 1981, as part of its final and interim final regulations implementing section 3001 of RCRA. EPA has amended this list several times and published it in 40 CFR 261.31 and 261.32.

EPA lists these wastes as hazardous because: (1) The wastes typically and frequently exhibit one or more of the characteristics of hazardous wastes identified in Subpart C of part 261 (that is, ignitability, corrosivity, reactivity, and toxicity), (2) the wastes meet the criteria for listing contained in § 261.11(a)(2) or (a)(3), or (b) the wastes are mixed with or derived from the treatment, storage or disposal of such characteristic and listed wastes and which therefore become hazardous under § 261.3(a)(2)(iv) or (c)(2)(i), known as the “mixture” or “derived-from” rules, respectively.

Individual waste streams may vary, however, depending on raw materials, industrial processes, and other factors. Thus, while a waste described in these regulations or resulting from the operation of the mixture or derived-from rules generally is hazardous, a specific waste from an individual facility may not be hazardous.

For this reason, 40 CFR 260.20 and 260.22 provide an exclusion procedure, called delisting, which allows persons to prove that EPA should not regulate a specific waste from a particular generating facility as a hazardous waste.

B. What is a delisting petition, and what does it require of a petitioner?

A delisting petition is a request from a facility to EPA or an authorized state to exclude wastes from the list of hazardous wastes. The facility petitions EPA because it does not consider the wastes hazardous under RCRA regulations.

In a delisting petition, the petitioner must show that wastes generated at a particular facility do not meet any of the criteria for which the waste was listed. The criteria for which EPA lists a waste are in part 261 and further explained in the background documents for the listed waste.

In addition, under 40 CFR 260.22, a petitioner must prove that the waste does not exhibit any of the hazardous waste characteristics (that is, ignitability, reactivity, corrosivity, and toxicity) and present sufficient information for EPA to decide whether factors other than those for which the waste was listed warrant retaining it as a hazardous waste. (See part 261 and the background documents for the listed waste.)

Generators remain obligated under RCRA to confirm whether their waste remains non-hazardous based on the hazardous waste characteristics, even if EPA has “delisted” the waste.

C. What factors must EPA consider in deciding whether to grant a delisting petition?

Besides considering the criteria in 40 CFR 260.22(a) and § 3001(f) of RCRA, 42 U.S.C. 6921(f), and in the background documents for the listed wastes, EPA must consider any factors (including additional constituents) other than those for which EPA listed the waste, if a reasonable basis exists that these additional factors could cause the waste to be hazardous.

EPA must also consider as hazardous waste mixtures containing listed hazardous wastes and wastes derived from treating, storing, or disposing of listed hazardous waste. See § 261.3(a)(2)(iii and iv) and (c)(2)(i), called the “mixture” and “derived-from” rules, respectively. These wastes are also eligible for exclusion and remain hazardous wastes until excluded. See 66 FR 27266 (May 16, 2001).

III. EPA's Evaluation of the Waste Information and Data A. What wastes did Blanchard petition EPA to Delist?

In June 2017, Blanchard petitioned EPA to exclude from the lists of hazardous wastes contained in §§ 261.31 and 261.32, residual solids (F037) generated during reclamation activities conducted at its GBR facility located in Texas City, Texas. The waste falls under the classification of listed waste pursuant to §§ 261.31 and 261.32. Specifically, in its petition, Blanchard requested that EPA grant a conditional exclusion for the annual generation volume of 20,000 cubic yards of F037 residual solids.

B. Who is Blanchard and what process does it use to generate the petitioned waste?

Blanchard owns and operates the GBR facility, located in Texas City, Galveston County, Texas. Blanchard is a wholly-owned subsidiary of Marathon Petroleum Company LP. Blanchard's demonstration evaluated representative samples of its residual solids resulting from the indirect thermal desorption reclamation of OBSMs managed on-site at Blanchard's GBR facility. OBSMs managed on-site at Blanchard's GBR facility result from separate management practices within GBR's petroleum refining operations. Blanchard's approved Sampling and Analysis Plan (SAP) identified three (3) management practices, which result in the generation of three (3) corresponding categories of OBSMs with unique physical properties. The three (3) identified categories of Blanchard's OBSMs include, Category 1, Oil/Water/Solid Separation Sludges (K048 through K052, F037 and F038); Category 2, Crude Oil and Clarified Slurry Oil Sediments (K169 and K170); and Category 3, Stabilized Spent Hydrotreating and Hydrorefining Catalysts (K171 and K172).

Blanchard's demonstration utilized a commercial indirectly-fired thermal desorption unit (“ITDU”) located at US Ecology Texas' (“USET”) permitted commercial facility in Robstown, Texas. Blanchard considered it prudent to utilize USET's ITDU to avoid having to invest the significant capital and resources required to site and construct a full-scale ITDU on-site at Blanchard's GBR facility, prior to receiving an approved delisting determination. The EPA acknowledged Blanchard's use of USET's commercial ITDU to perform its demonstration, under its approved SAP.

USET's commercial ITDU was designed and constructed by TD*X Associates LP (“TD*X”), located in Beaumont, Texas. TD*X currently operates the commercial ITDU on-site at USET's Robstown facility, under contract with USET. USET has extensive experience in the management and processing of Blanchard's OBSMs, and is currently contracted with Blanchard to provide such services at USET's Robstown facility.

Blanchard has entered into a services agreement with US Ecology Thermal Services LLC (“USETS”) to provide and operate an ITDU, on-site at its GBR facility. USETS is the refinery services affiliate of USET. Blanchard's proposed ITDU will be designed, constructed and operated by TD*X, as part of USETS's services agreement with Blanchard. The processing capabilities, efficiencies and capacity of Blanchard's proposed ITDU are comparable to USET's commercial ITDU that was utilized under Blanchard's demonstration.

C. How did Blanchard sample and analyze the data in this petition?

To support its petition, Blanchard conducted individual sampling events on residual solids resulting from the reclamation of Blanchard's three (3) identified categories of OBSMs. Each separate sampling event consisted of four (4) composite samples taken during a 24-hour period of representative operation. Each composite sample was comprised of individual grab samples (i.e. a minimum of four), obtained during separate six (6) hour periods of the 24-hour sampling event. Compositing of samples and performance of quality control requirements were performed by Blanchard's selected analytical laboratory, TestAmerica Laboratories, Inc. (“TestAmerica”). Blanchard submitted: Historical information on waste generation and management practices; and analytical results from twelve samples for total and TCLP concentrations of constituents of concern (COC)s.

D. What were the results of Blanchard's sample analyses?

EPA believes that the descriptions of the Blanchard analytical characterization provide a reasonable basis to grant Blanchard's petition for an exclusion of the residual solids. EPA believes the data submitted in support of the petition show the residual solids is non-hazardous. Analytical data for the residual solids samples were used in the DRAS to develop delisting levels. The residual solids from Category 3 can only be delisted if stabilization of the residual solids occur. Data from the stabilized Category 3 residual solids demonstrate the concentrations from the stabilized residuals meet the delisting requirements. The data summaries for COCs are presented in Table I. EPA has reviewed the sampling procedures used by Blanchard and has determined that it satisfies EPA criteria for collecting representative samples of the variations in constituent concentrations in the residual solids. In addition, the data submitted in support of the petition show that COCs in Blanchard's waste are presently below health-based levels used in the delisting decision-making. EPA believes that Blanchard has successfully demonstrated that the residual solids are non-hazardous.

Table 1—Analytical Results/Maximum Allowable Delisting Concentration [Residual solids—Blanchard Refining Company LLC, Texas City, Texas] Constituent Maximum total
  • concentration (mg/kg)
  • Maximum TCLP
  • concentration (mg/L)
  • Maximum
  • TCLP
  • delisting level (mg/L)
  • Acetone 0.185 0.226 520.0 Antimony 53.7 0.226 0.599 Anthracene 0.488 <0.0125 25.993 Arsenic 222.0 0.277 0.424 Barium 950.0 0.221 36.0 Benzene 1.25 <0.00280 0.077 Benzo (a) anthracene 0.512 <0.0106 0.070 Benzo(a) pyrene 0.0298 <0.0123 2.634 Benzo (b) flouranthene 0.286 <0.0125 22.43 Beryllium 8.61 0.235 1.764 Cadmium 0.441 <0.00280 0.217 Chromium 120.0 0.0550 3.06 Chrysene 0.272 <0.0103 7.006 Cobalt 242.0 0.818 0.902 Copper 639.0 <0.0813 21.527 Cyanide 99.4 <0.0702 3.08 Diethyl Phthalate 0.493 <0.0130 990 Flouranthrene 0.405 <0.0122 2.462 Flourene 0.420 <0.00710 4.91 Lead 963.0 <0.0219 0.984 2, methylphenol 1.31 <0.00710 28.952 3,4 methylphenol 2.18 <0.00675 28.952 Methylene Chloride 0.827 0.00756 0.0790 Methyl Naphthalene 0.365 <0.0129 0.727 Mercury 0.0403 0.000104 0.068 Naphthalene 0.874 <0.0110 0.0327 Nickel 29,000 <0.00800 13.5 Phenanthrene 2.16 <0.0112 10.626 Phenol 6.55 0.00813 173 Pyrene 1.76 <0.0150 4.446 Pyridine 0.197 <0.0108 0.5775 Selenium 13.5 0.0530 1.0 Silver 1.86 <0.0129 5.0 Toluene 0.670 <0.00275 15.1 Tin 13.8 <0.00590 387 Thallium 110.0 0.0220 0.0366 Vanadium 75,400 0.215 4.6436 Zinc 1920.0 0.487 197 Notes: These levels represent the highest constituent concentration found in any one sample and does not necessarily represent the specific level found in one sample.
    E. How did EPA evaluate the risk of delisting the waste?

    For this delisting determination, EPA used such information gathered to identify plausible exposure routes (i.e. groundwater, surface water, air) for hazardous constituents present in the petitioned waste. EPA determined that disposal in a landfill is the most reasonable, worst-case disposal scenario for Blanchard's petitioned waste. EPA applied the Delisting Risk Assessment Software (DRAS) described in 65 FR 58015 (September 27, 2000) and 65 FR 75637 (December 4, 2000), to predict the maximum allowable concentrations of hazardous constituents that may be released from the petitioned waste after disposal and determined the potential impact of the disposal of Blanchard's petitioned waste on human health and the environment. A copy of this software can be found on the world wide web at f://www.epa.gov/reg5rcra/wptdiv/hazardous/delisting/dras-software.html. In assessing potential risks to groundwater, EPA used the maximum waste volumes and the maximum reported extract concentrations as inputs to the DRAS program to estimate the constituent concentrations in the groundwater at a hypothetical receptor well down gradient from the disposal site. Using the risk level (carcinogenic risk of 10-5 and non-cancer hazard index of 1.0), the DRAS program can back-calculate the acceptable receptor well concentrations (referred to as compliance-point concentrations) using standard risk assessment algorithms and EPA health-based numbers. Using the maximum compliance-point concentrations and EPA's Composite Model for Underflow Water Migration with Transformation Products (EPACMTP) fate and transport modeling factors, the DRAS further back-calculates the maximum permissible waste constituent concentrations not expected to exceed the compliance-point concentrations in groundwater.

    EPA believes that the EPACMTP fate and transport model represents a reasonable worst-case scenario for possible groundwater contamination resulting from disposal of the petitioned waste in a surface impoundment, and that a reasonable worst-case scenario is appropriate when evaluating whether a waste should be relieved of the protective management constraints of RCRA Subtitle C. The use of some reasonable worst-case scenarios resulted in conservative values for the compliance-point concentrations and ensures that the waste, once removed from hazardous waste regulation, will not pose a significant threat to human health or the environment.

    The DRAS also uses the maximum estimated waste volumes and the maximum reported total concentrations to predict possible risks associated with releases of waste constituents through surface pathways (e.g. volatilization from the impoundment). As in the above groundwater analyses, the DRAS uses the risk level, the health-based data and standard risk assessment and exposure algorithms to predict maximum compliance-point concentrations of waste constituents at a hypothetical point of exposure. Using fate and transport equations, the DRAS uses the maximum compliance-point concentrations and back-calculates the maximum allowable waste constituent concentrations (or “delisting levels”).

    In most cases, because a delisted waste is no longer subject to hazardous waste control, EPA is generally unable to predict, and does not presently control, how a petitioner will manage a waste after delisting. Therefore, EPA currently believes that it is inappropriate to consider extensive site-specific factors when applying the fate and transport model. EPA does control the type of unit where the waste is disposed. The waste must be disposed in the type of unit the fate and transport model evaluates.

    The DRAS results which calculate the maximum allowable concentration of chemical constituents in the waste are presented in Table I. Based on the comparison of the DRAS and TCLP Analyses results found in Table I, the petitioned waste should be delisted because no COCs tested are likely to be present or formed as reaction products or by-products in Blanchard's waste.

    F. What did EPA conclude about Blanchard's waste analysis?

    EPA concluded, after reviewing Blanchard's processes, that no other hazardous COCs, other than those for which tested, are likely to be present or formed as reaction products or by-products in the waste. In addition, on the basis of explanations and analytical data provided by Blanchard, pursuant to § 260.22, EPA concludes that the petitioned waste does not exhibit any of the characteristics of ignitability, corrosivity, reactivity or toxicity. See §§ 261.21, 261.22 and 261.23, respectively.

    G. What other factors did EPA consider in its evaluation?

    During the evaluation of Blanchard's petition, EPA also considered the potential impact of the petitioned waste via non-groundwater routes (i.e. air emission and surface runoff). With regard to airborne dispersion in particular, EPA believes that exposure to airborne contaminants from Blanchard's petitioned waste is unlikely. Therefore, no appreciable air releases are likely from Blanchard's residual solids under any likely disposal conditions. EPA evaluated the potential hazards resulting from the unlikely scenario of airborne exposure to hazardous constituents released from Blanchard's residual solids in an open landfill. The results of this worst-case analysis indicated that there is no substantial present or potential hazard to human health and the environment from airborne exposure to constituents from Blanchard's residual solids.

    H. What is EPA's evaluation of this delisting petition?

    The descriptions of Blanchard's hazardous waste process and analytical characterization provide a reasonable basis for EPA to grant the exclusion. The data submitted in support of the petition show that constituents in the waste are below the leachable concentrations (see Table I). EPA believes that Blanchard's residual solids will not impose any threat to human health and the environment.

    Thus, EPA believes Blanchard should be granted an exclusion for the residual solids. EPA believes the data submitted in support of the petition show Blanchard's residual solids is non-hazardous. The data submitted in support of the petition show that constituents in Blanchard's waste is presently below the compliance point concentrations used in the delisting decision and would not pose a substantial hazard to the environment. EPA believes that Blanchard has successfully demonstrated that the residual solids sludge is non-hazardous.

    EPA therefore, proposes to grant an exclusion to Blanchard for the residual solids described in its petition. EPA's decision to exclude this waste is based on descriptions of the treatment activities associated with the petitioned waste and characterization of the residual solids.

    If EPA finalizes the proposed rule, EPA will no longer regulate the petitioned waste under Parts 262 through 268 and the permitting standards of Part 270.

    IV. Next Steps A. With what conditions must the petitioner comply?

    The petitioner, Blanchard, must comply with the requirements in 40 CFR part 261, Appendix IX, Table 1. The text below gives the rationale and details of those requirements.

    (1) Delisting Levels

    This paragraph provides the levels of constituents for which Blanchard must test the residual solids, below which these wastes would be considered non-hazardous. EPA selected the set of inorganic and organic constituents specified in Paragraph (1) of 40 CFR part 261, Appendix IX, Table 1, (the exclusion language) based on information in the petition. EPA compiled the inorganic and organic constituents list from the composition of the waste, descriptions of Blanchard's treatment process, previous test data provided for the waste, and the respective health-based levels used in delisting decision-making. These delisting levels correspond to the allowable levels measured in the TCLP concentrations.

    (2) Waste Holding and Handling

    The purpose of this paragraph is to ensure that Blanchard manages and disposes of any residual solids that contains hazardous levels of inorganic and organic constituents according to Subtitle C of RCRA. Managing the residual solids as a hazardous waste until the verification testing is performed will protect against improper handling of hazardous material. If EPA determines that the data collected under this paragraph do not support the data provided for in the petition, the exclusion will not cover the petitioned waste. The exclusion is effective upon publication in the Federal Register but the disposal of Blanchard's residual solids as non-hazardous cannot begin until the verification sampling is completed.

    (3) Verification, Subsequent, and Annual Testing Requirements

    Blanchard must complete a rigorous verification testing program on the residual solids to assure that the solids do not exceed the maximum levels specified in Paragraph (1) of the exclusion language. This verification program will occur as residual solids are discharged from Blanchard's reclamation process, prior to containment and disposal. The volume of residual solids generated may not exceed 20,000 cubic yards of sludge material annually. Any volume of residual solids generated in excess of 20,000 cubic yards during any twelve-month period must be disposed as hazardous wastes. If EPA determines that the data collected under this paragraph do not support the data provided for the petition, the exclusion will not cover the generated residual solids. If the data from the verification testing program demonstrate that the residual solids meet the delisting levels, Blanchard may commence disposing of the residual solids as non-hazardous solid waste. Blanchard will notify EPA in writing, if and when it begins and ends disposal of the delisted residual solids.

    (4) Changes in Operating Conditions

    If Blanchard significantly changes the reclamation process described in its petition or starts any processes that generate(s) the waste that may or could affect the composition or type of waste generated as established under Paragraph (1) (by illustration, but not limitation, changes in equipment or operating conditions of the treatment process), they must notify EPA in writing. Blanchard may no longer handle the residual solids generated from the new process as non-hazardous until they have completed verification testing described in Paragraph (3)(A) and (B).

    (5) Stabilization Operations

    Blanchard describes an application where it may periodically elect to modify operating conditions under its reclamation process to accommodate the addition of chemical stabilization reagents. The facility also provided data on stabilized materials as part of its petition. In the event Blanchard initiates the inclusion of stabilization during operation of its reclamation process, they may no longer handle the residual solids generated from the modified process as non-hazardous until the residual solids meet the delisting levels set in Paragraph (1) under initial verification testing requirements set in Paragraph (3)(A) and verify that no additional constituents are leaching from the stabilized residual solids. Following completion of modified operation of its reclamation process, Blanchard can resume normal operating conditions and testing requirements under Paragraph (3), which were in place prior to initiating the addition of stabilization.

    (6) Data Submittals

    To provide appropriate documentation that Blanchard's residual solids meet the delisting levels, Blanchard must compile, summarize, and keep delisting records on-site for a minimum of five years. It should keep all analytical data obtained through Paragraph (3) of the exclusion language including quality control information for five years. Paragraph (4) of the exclusion language requires that Blanchard furnish these data upon request for inspection by any employee or representative of EPA or the State of Texas.

    If the proposed exclusion is made final, it will apply only to the volume of 20,000 cubic yards of residual solids generated annually at Blanchard's GBR facility after successful verification testing. EPA would require Blanchard to file a new delisting petition for any volume of residual solids generated during any twelve-month period in excess of the 20,000 cubic yards, and manage the excess volume of residual solids as hazardous waste until EPA grants a new exclusion.

    When this exclusion becomes final, Blanchard's management of the residual solids covered by this petition would be relieved from Subtitle C jurisdiction, and the residual solids from Blanchard will be disposed of in an authorized, solid waste landfill (e.g. RCRA Subtitle D landfill, commercial/industrial solid waste landfill, etc.).

    (7) Reopener

    The purpose of Paragraph (6) of the exclusion language is to require Blanchard to disclose new or different information related to a condition at Blanchard's facility or disposal of the waste, if it is pertinent to the delisting. Blanchard must also use this procedure, if the annual testing fails to meet the levels found in Paragraph (1). This provision will allow EPA to reevaluate the exclusion, if a source provides new or additional information to EPA. EPA will evaluate the information on which EPA based the decision to see if it is still correct, or if circumstances have changed so that the information is no longer correct or would cause EPA to deny the petition, if presented. This provision expressly requires Blanchard to report differing site conditions or assumptions used in the petition, in addition to failure to meet the annual testing conditions within 10 days of discovery. If EPA discovers such information itself or from a third party, it can act on it as appropriate. The language being proposed is similar to those provisions found in RCRA regulations governing no-migration petitions at § 268.6.

    EPA believes that it has the authority under RCRA and the Administrative Procedures Act (APA), 5 U.S.C. 551 (1978) et seq., to reopen a delisting decision. EPA may reopen a delisting decision when it receives new information that calls into question the assumptions underlying the delisting.

    EPA believes a clear statement of its authority in delisting is merited, in light of EPA's experience. See Reynolds Metals Company at 62 FR 37694 and 62 FR 63458 where the delisted waste leached at greater concentrations in the environment than the concentrations predicted when conducting the TCLP, thus leading EPA to repeal the delisting. If an immediate threat to human health and the environment presents itself, EPA will continue to address these situations on a case-by-case basis. Where necessary, EPA will make a good cause finding to justify emergency rulemaking. See APA § 553(b).

    (8) Notification Requirements

    In order to adequately track wastes that have been delisted, EPA is requiring that Blanchard provide a one-time notification to any state regulatory agency through which or to which the delisted waste is being carried. Blanchard must provide this notification sixty (60) days before commencing this activity.

    B. What happens if Blanchard violates the terms and conditions?

    If Blanchard violates the terms and conditions established in the exclusion, EPA will start procedures to withdraw the exclusion. Where there is an immediate threat to human health and the environment, EPA will evaluate the need for enforcement activities on a case-by-case basis. EPA expects Blanchard to conduct the appropriate waste analysis and comply with the criteria explained above in Paragraph (1) of the exclusion.

    V. Public Comments A. How can I as an interested party submit comments?

    EPA is requesting public comments on this proposed decision. Submit your comments, identified by Docket ID No. EPA-R06-RCRA-2017-0556, at https://www.regulations.gov. Follow the online instructions for submitting comments. Once submitted, comments cannot be edited or removed from Regulations.gov. The EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission (i.e. on the web, cloud, or other file sharing system). For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit https://www2.epa.gov/dockets/commenting-epa-dockets.

    You should submit requests for a hearing to Kishor Fruitwala, Section Chief (6MM-RP), Multimedia Division, Environmental Protection Agency (EPA), 1445 Ross Avenue, Suite 1200, Dallas, Texas 75202.

    B. How may I review the docket or obtain copies of the proposed exclusion?

    You may review the RCRA regulatory docket for this proposed rule at the Environmental Protection Agency Region 6, 1445 Ross Avenue, Suite 1200, Dallas, Texas 75202. It is available for viewing in EPA Freedom of Information Act Review Room from 9:00 a.m. to 4:00 p.m., Monday through Friday, excluding Federal holidays. Call (214) 665-6444 for appointments. The public may copy material from any regulatory docket at no cost for the first 100 pages, and at fifteen cents per page for additional copies. Docket materials are available either electronically in https://www.regulations.gov and you may also request the electronic files of the docket which do not appear on regulations.gov.

    VI. Statutory and Executive Order Reviews

    Under Executive Order 12866, “Regulatory Planning and Review” (58 FR 51735, October 4, 1993), this rule is not of general applicability and therefore, is not a regulatory action subject to review by the Office of Management and Budget (OMB). This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.) because it applies to a particular facility only. Because this rule is of particular applicability relating to a particular facility, it is not subject to the regulatory flexibility provisions of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.), or to sections 202, 204, and 205 of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4). Because this rule will affect only a particular facility, it will not significantly or uniquely affect small governments, as specified in section 203 of UMRA. Because this rule will affect only a particular facility, this proposed rule 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, as specified in Executive Order 13132, “Federalism”, (64 FR 43255, August 10, 1999). Thus, Executive Order 13132 does not apply to this rule.

    Similarly, because this rule will affect only a particular facility, this proposed rule does not have tribal implications, as specified in Executive Order 13175, “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000). Thus, Executive Order 13175 does not apply to this rule. This rule also is not subject to Executive Order 13045, “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant as defined in Executive Order 12866, and because the Agency does not have reason to believe the environmental health or safety risks addressed by this action present a disproportionate risk to children. The basis for this belief is that the Agency used DRAS, which considers health and safety risks to children, to calculate the maximum allowable concentrations for this rule. This rule is not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355 (May 22, 2001)), because it is not a significant regulatory action under Executive Order 12866. This rule does not involve technical standards; thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. As required by section 3 of Executive Order 12988, “Civil Justice Reform”, (61 FR 4729, February 7, 1996), in issuing this rule, EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct.

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report which includes a copy of the rule to each House of the Congress and to the Comptroller General of the United States. Section 804 exempts from section 801 the following types of rules: (1) Rules of particular applicability; (2) rules relating to agency management or personnel; and (3) rules of agency organization, procedure, or practice that do not substantially affect the rights or obligations of non-agency parties (5 U.S.C. 804(3)). EPA is not required to submit a rule report regarding today's action under section 801 because this is a rule of particular applicability. Executive Order (EO) 12898 (59 FR 7629, February 16, 1994) establishes Federal executive policy on environmental justice. Its main provision directs Federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations and low-income populations in the United States.

    EPA has determined that this proposed rule will not have disproportionately high and adverse human health or environmental effects on minority or low-income populations because it does not affect the level of protection provided to human health or the environment. The Agency's risk assessment did not identify risks from management of this material in an authorized, solid waste landfill (e.g. RCRA Subtitle D landfill, commercial/industrial solid waste landfill, etc.). Therefore, EPA believes that any populations in proximity of the landfills used by this facility should not be adversely affected by common waste management practices for this delisted waste.

    Lists of Subjects in 40 CFR Part 261

    Environmental protection, Hazardous Waste, Recycling, Reporting and record-keeping requirements.

    Dated: October 17, 2017. Wren Stenger, Director, Multimedia Division, Region 6.

    For the reasons set forth in the preamble, 40 CFR part 261 is proposed to be amended as follows:

    PART 261—IDENTIFICATION AND LISTING OF HAZARDOUS WASTE 1. The authority citation for part 261 continues to read as follows: Authority:

    42 U.S.C. 6905, 6912(a), 6921, 6922, 6924(y) and 6938.

    2. In Table 1 of Appendix IX to part 261 add the entry “Blanchard Refining Company LLC” in alphabetical order to read as follows: Appendix IX to Part 261—Waste Excluded Under §§ 260.20 and 260.22 Table 1—Waste Excluded From Non-Specific Sources Facility Address Waste description *         *         *         *         *         *         * Blanchard Refining Company LLC Texas City, TX Residual solids (EPA Hazardous Waste Numbers F037) generated at a maximum rate of as 20,000 cubic yards annually. For the exclusion to be valid, Blanchard must implement a verification testing program that meets the following Paragraphs: (1) All leachable concentrations for those constituents must not exceed the following levels measured as mg/L (ppm). The petitioner must use an acceptable leaching method, for example SW-846, Method 1311, to measure constituents in the residual solids leachate. (A) Inorganic Constituents of Concern: Antimony—0.5985; Arsenic—0.424; Barium—36; Beryllium—1.74; Chromium—3.06; Cobalt—0.902; Lead—0.984; Nickel—13.5; Selenium—1.0; Vanadium—4.64, Zinc—197. Mercury—0.068. (B) Organic Constituents of Concern: Acetone—520.0; Anthracene—25.993; Benzene—0.077; Benzo(a)pyrene—2.634, Chrysene—7.006; Methylene Chloride—0.0790; Phenanthrene—10.626; Phenol—173; Pyrene—4.446. (2) Waste Holding and Handling: (A) Blanchard must manage and dispose its residual solids as hazardous waste generated under Subtitle C of RCRA, until they have completed verification testing described in Paragraph (3)(A) and (B), as appropriate, and valid analyses show that paragraph (1) is satisfied. (B) Levels of constituents measured in the samples of the residual solids that do not exceed the levels set forth in Paragraph (1) are nonhazardous. Blanchard can manage and dispose the nonhazardous residual solids according to all applicable solid waste regulations. (C) If constituent levels in a sample exceed any of the delisting levels set in Paragraph (1), Blanchard must retreat or stabilize the residual solids represented by the sample exceeding the delisting levels, until it meets the levels in paragraph (1). Blanchard must repeat the analyses of the retreated residual solids. (3) Verification Testing Requirements: Blanchard must perform analytical testing by sampling and analyzing the Residual solids as follows: (i) Collect representative samples of the Residual solids for analysis of all constituents listed in paragraph (1) prior to disposal. (ii) The samples for verification testing shall be a representative sample according to appropriate methods. As applicable to the method-defined parameters of concern, analyses requiring the use of SW-846 methods incorporated by reference in 40 CFR 260.11 must be used without substitution. As applicable, the SW-846 methods might include Methods 0010, 0011, 0020, 0023A, 0030, 0031, 0040, 0050, 0051, 0060, 0061, 1010A, 1020B,1110A, 1310B, 1311, 1312, 1320, 1330A, 9010C, 9012B, 9040C, 9045D, 9060A, 9070A (uses EPA Method 1664, Rev. A), 9071B, and 9095B. Methods must meet Performance Based Measurement System Criteria in which the Data Quality Objectives are to demonstrate that samples of the Blanchard residual solids are representative for all constituents listed in paragraph (1). Blanchard must perform sample collection and analyses, including quality control procedures, according to SW-846 methodologies. (A) Initial Verification Testing: After EPA grants the final exclusion, Blanchard must do the following: (i) Collect four (4) representative composite samples of the residual solids at weekly intervals after EPA grants the final exclusion. The first composite samples may be taken at any time after EPA grants the final approval. Sampling should be performed in accordance with the sampling plan approved by EPA in support of the exclusion. (ii) Analyze the samples for all constituents listed in paragraph (1). Any composite sample taken that exceeds the delisting levels listed in paragraph (1) for the residual solids must be disposed as hazardous waste in accordance with the applicable hazardous waste requirements. (iii) Within thirty (30) days after successfully completing its initial verification testing, Blanchard may report its analytical test data for its initial four (4) weekly composite samples to EPA. If levels of constituents measured in the samples of the residual solids do not exceed the levels set forth in paragraph (1) of this exclusion, Blanchard can manage and dispose the non-hazardous residual solids according to all applicable solid waste regulations. (B) Subsequent Verification Testing: If Blanchard completes initial verification testing requirements, specified in paragraph (3)(A), and no sample contains a constituent at a level which exceeds the limits set forth in paragraph (1), Blanchard may begin subsequent verification testing as follows: (i) Blanchard must test representative composite samples of the residual solids for all constituents listed in paragraph (1) at least once per month. (ii) The samples for the monthly testing shall be a representative composite sample according to appropriate methods. (iii) Within thirty (30) days after completing each monthly sampling, Blanchard will report its analytical test data to EPA. (C) Annual Verification Testing: If levels of constituents measured in the samples of the residual solids do not exceed the levels set forth in paragraph (1) of this exclusion for six (6) consecutive months of subsequent verification testing, Blanchard may begin annual testing as follows: (i) Blanchard must test representative composite samples of the residual solids for all constituents listed in paragraph (1) at least once per calendar year. (ii) The samples for the annual testing shall be a representative composite sample according to appropriate methods. (iii) Within sixty (60) days after completing each annual sampling, Blanchard will report its analytical test data to EPA. (D) Termination of Organic Testing: Blanchard must continue testing as required under Paragraph (3)(B) for organic constituents in Paragraph (1)(B), until the analytical results submitted under Paragraph (3)(B) show a minimum of three (3) consecutive monthly samples below the delisting levels in Paragraph (1). Following receipt of approval from EPA in writing, Blanchard may terminate organic testing. (4) Changes in Operating Conditions: If Blanchard significantly changes the process described in its petition or starts any processes that generate(s) the waste that may or could affect the composition or type of waste generated as established under Paragraph (1) (by illustration, but not limitation, changes in equipment or operating conditions of the treatment process), they must notify EPA in writing. Blanchard may no longer handle the residual solids generated from the new process as nonhazardous until they have completed verification testing described in Paragraph (3)(A) and (B), as appropriate, documented that valid analyses show that paragraph (1) is satisfied, and received written approval from EPA. (5) Stabilization Operation: Blanchard may periodically elect to modify operating conditions to accommodate the addition of chemical stabilization reagents during indirect thermal desorption processing. In the event that Blanchard initiates the inclusion of stabilization during operation, they may no longer handle the residual solids generated from the modified process as nonhazardous until the residual solids meet the delisting levels set in Paragraph (1) under initial verification testing requirements set in paragraph (3)(A) and verify that the stabilization reagents do not add additional constituents to the residual solid leachate. Following completion of modified operation, Blanchard can resume normal operating conditions and testing requirements under Paragraph (3), which were in place prior to initiating stabilization during operation. (6) Data Submittals: Blanchard must submit the information described below. If Blanchard fails to submit the required data within the specified time or maintain the required records on-site for the specified time, EPA, at its discretion, will consider this sufficient basis to reopen the exclusion as described in paragraph (6). Blanchard must: (A) Submit the data obtained through paragraph 3 to the Section Chief, 6MM-RP, Multimedia Division, U. S. Environmental Protection Agency Region 6, 1445 Ross Ave., Suite 1200, Dallas, Texas 75202, within the time specified. All supporting data can be submitted on CD-ROM or comparable electronic media. (B) Compile records of analytical data from paragraph (3), summarized, and maintained on-site for a minimum of five years. (C) Furnish these records and data when either EPA or the State of Texas requests them for inspection. (D) Send along with all data a signed copy of the following certification statement, to attest to the truth and accuracy of the data submitted: “Under civil and criminal penalty of law for the making or submission of false or fraudulent statements or representations (pursuant to the applicable provisions of the Federal Code, which include, but may not be limited to, 18 U.S.C. § 1001 and 42 U.S.C. § 6928), I certify that the information contained in or accompanying this document is true, accurate and complete. As to the (those) identified section(s) of this document for which I cannot personally verify its (their) truth and accuracy, I certify as the company official having supervisory responsibility for the persons who, acting under my direct instructions, made the verification that this information is true, accurate and complete. If any of this information is determined by EPA in its sole discretion to be false, inaccurate or incomplete, and upon conveyance of this fact to the company, I recognize and agree that this exclusion of waste will be void as if it never had effect or to the extent directed by EPA and that the company will be liable for any actions taken in contravention of the company's RCRA and CERCLA obligations premised upon the company's reliance on the void exclusion.” (7) Reopener. (A) If, any time after disposal of the delisted waste Blanchard possesses or is otherwise made aware of any environmental data (including but not limited to underflow water data or ground water monitoring data) or any other data relevant to the delisted waste indicating that any constituent identified for the delisting verification testing is at level higher than the delisting level allowed by the Division Director in granting the petition, then the facility must report the data, in writing, to the Division Director within 10 days of first possessing or being made aware of that data. (B) If either the verification testing (and retest, if applicable) of the waste does not meet the delisting requirements in paragraph 1, Blanchard must report the data, in writing, to the Division Director within 10 days of first possessing or being made aware of that data. (C) If Blanchard fails to submit the information described in paragraphs (5), (6)(A) or (6)(B) or if any other information is received from any source, the Division Director will make a preliminary determination as to whether the reported information requires EPA action to protect human health and/or the environment. Further action may include suspending, or revoking the exclusion, or other appropriate response necessary to protect human health and the environment. (D) If the Division Director determines that the reported information requires action by EPA, the Division Director will notify the facility in writing of the actions the Division Director believes are necessary to protect human health and the environment. The notice shall include a statement of the proposed action and a statement providing the facility with an opportunity to present information as to why the proposed EPA action is not necessary. The facility shall have 10 days from receipt of the Division Director's notice to present such information. (E) Following the receipt of information from the facility described in paragraph (6)(D) or (if no information is presented under paragraph (6)(D)) the initial receipt of information described in paragraphs (5), (6)(A) or (6)(B), the Division Director will issue a final written determination describing EPA actions that are necessary to protect human health and/or the environment. Any required action described in the Division Director's determination shall become effective immediately, unless the Division Director provides otherwise. (8) Notification Requirements: Blanchard must do the following before transporting the delisted waste. Failure to provide this notification will result in a violation of the delisting petition and a possible revocation of the decision. (A) Provide a one-time written notification to any state Regulatory Agency to which or through which it will transport the delisted waste described above for disposal, 60 days before beginning such activities. (B) For onsite disposal, a notice should be submitted to the State to notify the State that disposal of the delisted materials has begun. (C) Update one-time written notification, if it ships the delisted waste into a different disposal facility. (D) Failure to provide this notification will result in a violation of the delisting exclusion and a possible revocation of the decision. *         *         *         *         *         *         *
    [FR Doc. 2017-23683 Filed 10-30-17; 8:45 am] BILLING CODE 6560-50-P
    DEPARTMENT OF TRANSPORTATION Federal Motor Carrier Safety Administration 49 CFR Part 395 [Docket No. FMCSA-2017-0297] Hours of Service of Drivers: Application for Exemption; National Pork Producers Council (NPPC) AGENCY:

    Federal Motor Carrier Safety Administration (FMCSA), DOT.

    ACTION:

    Notice of application for exemption; request for comments.

    SUMMARY:

    FMCSA announces that the National Pork Producers Council (NPPC) has requested an exemption from the requirement that a motor carrier require each of its drivers to use an electronic logging device (ELD) no later than December 18, 2017, to record the driver's hours-of-service (HOS). NPPC states it requests the exemption for all livestock haulers as defined in the application (i.e., transporters of livestock, poultry, aquaculture, and insects) to address an incompatibility between the FMCSA's HOS rules and the current structure and realities of the U.S. livestock industry. NPPC states that the livestock haulers will not be prepared to meet the December 18, 2017, compliance date for installing ELDs. NPPC believes that the exemption, if granted, would achieve a level of safety that is equivalent to, or greater than, the level that would be achieved absent such exemption. FMCSA requests public comment on NPPC's application for exemption.

    DATES:

    Comments must be received on or before November 30, 2017.

    ADDRESSES:

    You may submit comments identified by Federal Docket Management System (FDMS) Number FMCSA-2017-0297 by any of the following methods:

    Federal eRulemaking Portal: www.regulations.gov. See the Public Participation and Request for Comments section below for further information.

    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., between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

    Fax: 1-202-493-2251

    • Each submission must include the Agency name and the docket number for this notice. Note that DOT posts all comments received without change to www.regulations.gov, including any personal information included in a comment. Please see the Privacy Act heading below.

    Docket: For access to the docket to read background documents or comments, go to www.regulations.gov at any time or visit Room W12-140 on the ground level of the West Building, 1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., ET, Monday through Friday, except Federal holidays. The on-line FDMS is available 24 hours each day, 365 days each year.

    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.

    FOR FURTHER INFORMATION CONTACT:

    For information concerning this notice, contact Mr. Tom Yager, Chief, FMCSA Driver and Carrier Operations Division; Office of Carrier, Driver and Vehicle Safety Standards; Telephone: 614-942-6477. Email: [email protected] If you have questions on viewing or submitting material to the docket, contact Docket Services, telephone (202) 366-9826.

    SUPPLEMENTARY INFORMATION:

    I. Public Participation and Request for Comments

    FMCSA encourages you to participate by submitting comments and related materials.

    Submitting Comments

    If you submit a comment, please include the docket number for this notice (FMCSA-2017-0297), indicate the specific section of this document to which the comment applies, and provide a reason for suggestions or recommendations. 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 the Agency can contact you if it has questions regarding your submission.

    To submit your comments online, go to www.regulations.gov and put the docket number, “FMCSA-2017-0297” in the “Keyword” box, and click “Search.” When the new screen appears, click on “Comment Now!” button and type your comment into the text box in 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 grant or not grant this application based on your comments.

    II. Legal Basis

    FMCSA has authority under 49 U.S.C. 31136(e) and 31315 to grant exemptions from certain parts of the Federal Motor Carrier Safety Regulations (FMCSRs). FMCSA must publish a notice of each exemption request in the Federal Register (49 CFR 381.315(a)). The Agency must provide the public an opportunity to inspect the information relevant to the application, including any safety analyses that have been conducted. The Agency must also provide an opportunity for public comment on the request.

    The Agency reviews safety analyses and public comments submitted, and determines whether granting the exemption would likely achieve a level of safety equivalent to, or greater than, the level that would be achieved by the current regulation (49 CFR 381.305). The decision of the Agency must be published in the Federal Register (49 CFR 381.315(b)) with the reasons for denying or granting the application and, if granted, the name of the person or class of persons receiving the exemption, and the regulatory provision from which the exemption is granted. The notice must also specify the effective period and explain the terms and conditions of the exemption. The exemption may be renewed (49 CFR 381.300(b)).

    III. Request for Exemption

    NPPC filed this application for exemption on behalf of itself and the following organizations: American Beekeeping Federation; American Farm Bureau Federation; Livestock Marketing Association; National Aquaculture Association; National Cattleman's Beef Association; North American Meat Institute; and the U.S. Cattlemen's Association.

    NPPC requests an exemption for all livestock haulers, which they define as “livestock, poultry, aquaculture, and insect producers, processors and transporters,” from the requirement in 49 CFR part 395 that no later than December 18, 2017, a motor carrier require each of its drivers to use an electronic logging device (ELD) to record the driver's hours-of-service (HOS).

    NPPC states that it is seeking this limited exemption from ELDs for livestock haulers because:

    (1) Livestock haulers are not, and will not be prepared to meet the December 18, 2017 compliance date;

    (2) The current ELD retail marketplace does not clearly support the needs of livestock haulers and questions remain as to whether current ELD devices can accommodate HOS exemptions currently utilized by the livestock industry;

    (3) There is a significant lack of education and awareness by livestock haulers and the livestock producers they service regarding the ELD mandate, current exemptions, and the use and operation of ELDs, requiring time for adequate outreach and training to take place; and

    (4) Concern over the ELD mandate has exposed incompatibilities between the HOS rules and the livestock industry, and is causing disruption for livestock haulers, increasing already severe driver shortages, and endangering the health and welfare of the millions of animals transported by livestock carriers daily.

    NPPC notes that their industry is encountering two problem areas regarding the use of ELDs. First, because the ELD initiative fails to directly address the unique requirements of the livestock industry, those drivers who are aware of the program have had difficulty researching the ELD marketplace and identifying cost-effective solutions that are compatible with livestock hauling. NPPC claims that the vendors in the commercial ELD marketplace lack an understanding of the unique needs of the livestock industry and essential design features for their products. Second, nationwide, the average age of American truck drivers is 49. For livestock haulers, the age is likely significantly higher. As a result, these drivers are less familiar with the use of new technology and require more time to train on ELD use. Forcing these drivers to comply with the ELD mandate without appropriate training unfairly discriminates against older drivers who are otherwise more experienced and qualified to haul livestock.

    IV. Method To Ensure an Equivalent or Greater Level of Safety

    NPPC claims that granting this exemption for the extremely limited segment of the overall transportation economy engaged in the shipment of livestock, will achieve a level of safety that is equivalent to, or greater than, the level that would be achieved absent an exemption.

    In their application, NPPC explains that livestock haulers are responsible for the daily transportation of millions of animals. They state that the welfare and safety of the animals in transit, together with the safety of other drivers on the road, are the industry's top priorities. NPPC advises that most livestock haulers have participated in additional specialized training, including the pork industry's Transport Quality Assurance (TQA) program and the beef industry's Master Castle Transporter (MCT) program, which provide instruction on proper animal handling and transportation methods. These voluntary education programs were developed by and are offered through the U.S. Department of Agriculture.

    The pork industry's TQA program is designed to address the driver safety and animal welfare needs of the approximately 600,000 pigs transported every day on U.S. roads. While the program is voluntary, most major packers require that any driver arriving on their property be TQA-certified. The beef industry's MCT training program was designed by cattle experts and volunteers to educate haulers about low-stress safe handling and transportation methods for cattle. According to the MCT training program, proper handling and transport of cattle reduces sickness, prevents bruising, and improves the quality of the meat. These drivers also transport live fish, which requires a driver to focus on road safety, equipment maintenance, fish health, and water quality. Moving live fish by truck also requires specialized equipment, species-specific loading, and on-time delivery.

    NPPC states that the emphasis these programs place on animal welfare benefits driver safety, as it encourages livestock haulers to slow down, be more aware of their surroundings and road conditions, and avoid rough-road situations that could result in animal injury. In addition to general highway safety and accident prevention measures, these programs also focus on the primary underlying goal of the HOS rule—addressing fatigue. For example, the pork industry's TQA program educates haulers about driver fatigue prevention by stressing adequate rest, appropriate climate conditions in the cab, a healthy diet, and how to recognize the signs of fatigue.

    NPPC states that granting a limited exemption from the ELD mandate for livestock haulers will enable FMCSA and the livestock industry to undertake the training and education necessary for livestock haulers to understand ELDs. It will also provide an opportunity for FMCSA to develop livestock-specific solutions to the underlying HOS concerns of the industry.

    A copy of NPPC's application for exemption is available for review in the docket for this notice.

    Issued on: October 25, 2017. Larry W. Minor, Associate Administrator for Policy.
    [FR Doc. 2017-23690 Filed 10-30-17; 8:45 am] BILLING CODE 4910-EX-P
    DEPARTMENT OF THE INTERIOR Fish and Wildlife Service 50 CFR Part 17 [Docket No. FWS-R6-ES-2016-0086; 4500030113] RIN 1018-BB52 Endangered and Threatened Wildlife and Plants; 12-Month Finding on a Petition to List the Western Glacier Stonefly as an Endangered or Threatened Species; Proposed Threatened Species Status for Meltwater Lednian Stonefly and Western Glacier Stonefly AGENCY:

    Fish and Wildlife Service, Interior.

    ACTION:

    Proposed rule; reopening of the comment period.

    SUMMARY:

    We, the U.S. Fish and Wildlife Service (Service), announce the reopening of the comment period on our October 4, 2016, proposed rule to list the western glacier stonefly (Zapada glacier) and the meltwater lednian stonefly (Lednia tumana) as threatened species under the Endangered Species Act of 1973, as amended (Act). We are reopening the comment period because we have received additional information about the range of the western glacier stonefly and reopening the comment period will provide the public an opportunity to comment on the additional range information. In August 2016, we received new information on the western glacier stonefly, indicating a larger range than previously known. In March 2017, we again received additional information (separate from the information received in August 2016) regarding the western glacier stonefly range, also indicating a larger range than previously known. We invite the public to comment on this additional information.

    DATES:

    The comment period on the October 4, 2016, proposed rule (81 FR 68379) is reopened. Comments should be received on or before November 30, 2017. Comments submitted electronically using the Federal eRulemaking Portal (see ADDRESSES, below) must be received by 11:59 p.m. Eastern Time on the closing date.

    ADDRESSES:

    You may submit comments by one of the following methods:

    (1) Electronically: Go to the Federal eRulemaking Portal: http://www.regulations.gov. In the Search box, enter FWS-R6-ES-2016-0086, which is the docket number for this rulemaking. Then, in the Search panel on the left side of the screen, under the Document Type heading, click on the Proposed Rules link to locate this document. You may submit a comment by clicking on “Comment Now!”

    (2) By hard copy: Submit by U.S. mail or hand-delivery to: Public Comments Processing, Attn: FWS-R6-ES-2016-0086, U.S. Fish and Wildlife Service, MS: BPHC, 5275 Leesburg Pike, Falls Church, VA 22041-3803.

    We request that you send comments only by the methods described above. We will post all comments on http://www.regulations.gov. This generally means that we will post any personal information you provide us (see Public Comments, below, for more information).

    Document availability: You may view the October 4, 2016, proposed rule and supporting materials associated with this reopened public comment period and described below under SUPPLEMENTARY INFORMATION at http://www.regulations.gov under Docket No. FWS-R6-ES-2016-0086, or from the office listed in FOR FURTHER INFORMATION CONTACT.

    FOR FURTHER INFORMATION CONTACT:

    Jodi Bush, Field Supervisor, U.S. Fish and Wildlife Service, Montana Ecological Services Field Office, 585 Shepard Way, Helena, MT 59601; telephone 406-449-5225; facsimile 406-449-5339; [email protected] Persons who use a telecommunications device for the deaf (TDD) may call the Federal Relay Service at 800-877-8339.

    SUPPLEMENTARY INFORMATION:

    Information Requested Public Comments

    We will accept written comments and information during this reopened comment period regarding the new information indicating additional streams and springs occupied by the western glacier stonefly (Giersch et al. 2016, entire; Giersch 2017, pers. comm.) as described in this document. We will also accept written comments and information on our proposed rule to list the western glacier stonefly and the meltwater lednian stonefly as threatened species under the Act that was published in the Federal Register on October 4, 2016 (81 FR 68379). We will consider information and recommendations from all interested parties.

    In addition, we continue to seek comments on the following topics as requested in our October 4, 2016, proposed rule (81 FR 68379):

    (1) The meltwater lednian stonefly and the western glacier stonefly biology, range, and population trends, including:

    (a) Biological or ecological requirements of the species, including habitat requirements for feeding, breeding, and sheltering;

    (b) Genetics and taxonomy;

    (c) Historical and current range, including distribution patterns;

    (d) Historical and current population levels, and current and projected trends; and

    (e) Past and ongoing conservation measures for the species, their habitat, or both.

    (2) Factors that may affect the continued existence of the species, which may include habitat modification or destruction, overutilization, disease, predation, the inadequacy of existing regulatory mechanisms, or other natural or manmade factors.

    (3) Biological, commercial trade, or other relevant data concerning any threats (or lack thereof) to these species and existing regulations that may be addressing those threats.

    (4) Additional information concerning the historical and current status, range, distribution, and population size of these species, including the locations of any additional populations.

    If you submitted comments or information on the proposed rule (81 FR 68379) during the initial comment period from October 4, 2016, to December 5, 2016, please do not resubmit them. Any such comments are incorporated as part of the public record of this rulemaking proceeding, and we will fully consider them in the preparation of our final determination. Our final determination will take into consideration all written comments and any additional information we receive during all comment periods. The final decision may differ from the proposed rule, based on our review of all information received during this rulemaking proceeding.

    Please include sufficient information with your submission (such as scientific journal articles or other publications) to allow us to verify any scientific or commercial information you include. Please note that submissions merely stating support for or opposition to the action under consideration without providing supporting information, although noted, will not be considered in making a determination, as section 4(b)(1)(A) of the Act directs that determinations as to whether any species is an endangered or a threatened species must be made “solely on the basis of the best scientific and commercial data available.”

    You may submit your comments and materials concerning the proposed rule by one of the methods listed in ADDRESSES. We request that you send comments only by the methods described in ADDRESSES.

    If you submit information via http://www.regulations.gov, your entire submission—including any personal identifying information—will be posted on the Web site. If your submission is made via a hardcopy that includes personal identifying information, you may request at the top of your document that we withhold this information from public review. However, we cannot guarantee that we will be able to do so. We will post all hardcopy submissions on http://www.regulations.gov.

    Comments and materials we receive, as well as supporting documentation we used in preparing the proposed rule, will be available for public inspection on http://www.regulations.gov, or by appointment, during normal business hours, at the U.S. Fish and Wildlife Service, Montana Ecological Services Field Office (see FOR FURTHER INFORMATION CONTACT).

    Peer Review

    In accordance with our joint policy on peer review published in the Federal Register on July 1, 1994 (59 FR 34270), we sought the expert opinions of six appropriate and independent specialists regarding the proposed rule, including the new information discussed in this document, and received comments or peer reviews from four peer reviewers. The purpose of peer review is to ensure that our listing determinations are based on scientifically sound data, assumptions, and analyses. The peer reviewers have expertise in stonefly biology, habitat, and life history.

    Background Species Information and Previous Federal Actions

    On October 4, 2016, we published a 12-month finding for the western glacier stonefly and a proposed rule to list the western glacier stonefly and meltwater lednian stonefly as threatened species under the Act (81 FR 68379). We combined the 12-month finding and proposed rule in one document for efficiency. Please refer to that proposed rule for information about western glacier stonefly and meltwater lednian stonefly taxonomy, descriptions of the two species, distribution and abundance, habitat, and biology, as well as a detailed description of previous Federal actions concerning the western glacier stonefly and meltwater lednian stonefly prior to October 4, 2016. As discussed in our proposed rule, we became aware of information in August 2016 indicating additional streams and springs occupied by western glacier stonefly in southwestern Montana and northwestern Wyoming. Furthermore, in March 2017, we became aware of additional information on western glacier stonefly, indicating a larger range than previously known. This new information from August 2016 and March 2017 is described below.

    New Information

    We received updated information on the distribution of western glacier stonefly from the United States Geological Survey (USGS) on August 22, 2016. This information was included in a final report to the Service examining the status, distribution, and ecology of the meltwater lednian stonefly and the western glacier stonefly (Giersch et al. 2016, entire). In this report, USGS documented western glacier stonefly approximately 500 miles farther south than previously known (Giersch et al. 2016, p. 28). These southern streams and springs were in the Absaroka-Beartooth Wilderness in southern Montana and in Grand Teton National Park in northwestern Wyoming. On March 22, 2017, we again received updated information on the distribution of western glacier stonefly from the USGS. This information was from field surveys conducted in late 2016. These surveys identified additional occupied streams and springs of western glacier stonefly in southern Montana and northwestern Wyoming (in the Absaroka-Beartooth Wilderness and Grand Teton National Park; Figure 1).

    In addition, a study funded by the Wyoming Natural Diversity Database estimated the degree to which western glacier stonefly were genetically different amongst the three mountain ranges (Glacier National Park, Absaroka-Beartooth Wilderness, and Grand Teton National Park) (Hotaling et al. 2017, p. 11). Although the study noted that there is evidence of significant genetic differentiation amongst western glacier stonefly populations residing in the different mountain ranges, the authors do not believe the evidence supports multiple species designations (Hotaling et al. 2017, p. 12). As a result of the additional range information and genetics report, we are now aware of a total of 16 occupied streams or springs of western glacier stonefly rangewide (Montana and Wyoming).

    BILLING CODE 4333-15-P EP31OC17.003 BILLING CODE 4333-15-C References Cited

    A complete list of references cited in this document is available on the Internet at http://www.regulations.gov at Docket No. FWS-R6-ES-2016-0086 and upon request from the Montana Ecological Services Field Office (see FOR FURTHER INFORMATION CONTACT).

    Authors

    The primary authors of this document are the staff members of the Montana Ecological Services Field Office.

    Authority

    The authority for this action is the Endangered Species Act of 1973, as amended (16 U.S.C. 1531 et seq.).

    Dated: September 28, 2017. James W. Kurth, Acting Director, U.S. Fish and Wildlife Service.
    [FR Doc. 2017-23579 Filed 10-30-17; 8:45 am] BILLING CODE 4333-15-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 253 [Docket No. 170404355-7355-01] RIN 0648-BG80 Merchant Marine Act and Magnuson-Stevens Act Provisions; Fishing Vessel, Fishing Facility and Individual Fishing Quota and Harvesting Rights Lending Program Regulations AGENCY:

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

    ACTION:

    Proposed rule; request for comments.

    SUMMARY:

    NMFS' Fisheries Finance Program (FFP) provides long-term financing to the commercial fishing and aquaculture industries for fishing vessels, fisheries facilities, aquaculture facilities, and certain designated individual fishing quota (IFQ). Section 302 of the Coast Guard Authorization Act of 2015 (Pub. L. 114-120) included new authority to finance the purchase of harvesting rights in a fishery that is federally managed under a limited access system. The FFP proposes to add a new section to the existing FFP regulations to implement this statutory change. The net effect of this proposed change to the regulations will be to provide additional authority for the program to lend, while leaving the original IFQ authority to Fishery Management Councils to use as needed.

    DATES:

    Comments must be submitted in writing on or before November 30, 2017,

    ADDRESSES:

    You may submit comments, identified by NOAA-NMFS-2017-0064, by any one of the following methods:

    Electronic Submission: Submit all electronic public comments via the Federal e-Rulemaking Portal. Go to www.regulations.gov/#!docketDetail;D=NOAA-NMFS-2017-0064, click the “Comment Now!” icon, complete the required fields, and enter or attach your comments.

    Mail: Paul Marx, Chief, Financial Services Division, NMFS, Attn: F/MB5, 1315 East-West Highway, SSMC3, Silver Spring, MD 20910.

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

    Written comments regarding the burden-hour estimates or other aspects of the collection-of-information requirements contained in this proposed rule may be submitted to [email protected] and by email to [email protected] or fax to (202) 395-7285.

    FOR FURTHER INFORMATION CONTACT:

    Paul Marx, at 301-427-8771 or via email at [email protected]

    SUPPLEMENTARY INFORMATION:

    Under the authority of Chapter 537 of Title 46 of the United States Code, 46 U.S.C. 53701, et seq., the FFP may provide long-term financing to the commercial fishing and aquaculture industries for fishing vessels, fisheries facilities, aquaculture facilities, and certain designated individual fishing quota (IFQs). Section 302 of the Coast Guard Authorization Act of 2015 (Pub. L. 114-120) amended Chapter 537, providing the FFP with the authority to finance the purchase of harvesting rights in a fishery that is federally managed under a limited access system. This amendment is codified at 46 U.S.C. 53702(b)(4)(B). This action would modify the existing Program regulations to reflect this statutory change. The net effect of this change will be to provide additional authority for the program to lend, while leaving the original IFQ authority to Fishery Management Councils (FMCs) to use as needed.

    Existing IFQ Loan Authority

    46 U.S.C. 53706 authorizes the FFP to finance or refinance the purchase of individual fishing quotas in accordance with section 303(d)(4) of the Magnuson-Stevens Fishery Conservation and Management Act (MSA), now codified at 16 U.S.C. 1853a(g). Under this provision of the MSA, an FMC may submit, and NMFS may approve and implement, a loan program to aid in (1) the acquisition of IFQ by fishermen who fish from “small vessels,” and (2) the first time purchase of IFQ by “entry level fishermen.” Therefore, under this authority, the FFP cannot initiate or implement a lending program to finance or refinance the purchase of IFQ until the appropriate FMC submits a request to NMFS and provides guidance for the requisite criteria.

    NMFS currently administers two loan programs pursuant to the existing IFQ authority: The Northwest Halibut/Sablefish and Bering Sea and Aleutian Islands Crab IFQ loan programs. NMFS anticipates no effects to either of these existing loan programs as a result of this proposed action.

    New Loan Authority

    The new authority provided by Public Law 114-120 broadens the FFP's existing authority, and authorizes the Program to finance the purchase of harvesting rights in a fishery that is federally managed under a limited access system. NMFS will interpret “limited access system” in accordance with section 3(27) of the MSA for purposes of this authority. The MSA defines “limited access system” as “a system that limits participation in a fishery to those satisfying certain eligibility criteria or requirements contained in a fishery management plan or associated regulation.” 16 U.S.C. 1802(27). Such definition includes, but is not limited to, IFQ fisheries.

    The new authority provided by Public Law 114-120 does not require FMCs to initiate a request to establish a loan program in a fishery that is federally managed under a limited access system in order for the FFP to provide financing in such a fishery. However, under the MSA, FMCs are primarily responsible for developing fishery management plans (FMPs) for fisheries within their authority that require conservation and management. It is possible that the availability of fisheries loans may have unanticipated effects on the achievement of FMP goals and objectives. Therefore, NMFS believes it appropriate to allow the FMCs to comment on the potential or actual effect of a loan program for harvesting rights in fisheries under their authority. An FMC may provide an explanation to NMFS at any time, in writing, why the potential or continuing availability of financing for harvesting rights in a fishery under its authority would harm the achievement of the goals and objectives of the FMP applicable to the fishery. If NMFS accepts the Council's reasoning, harvesting rights loans would not be provided, or would cease to be provided, in that fishery. In such a scenario, NMFS would publish a notice in the Federal Register notifying the public that new loans will not be made in that fishery. If there were already loan applications under consideration, the exceptional circumstances would justify NMFS returning any loan fees submitted with loan applications. The opportunity for FMC input will help ensure that loans made by the FFP do not undermine or conflict with the goals and objectives of specific FMPs.

    Extent of Financing

    Section 302 of the Coast Guard Authorization Act of 2015 imposes no limitations on the extent of financing to be provided by the FFP for the purchase of harvesting rights. However, it does reserve $59 million of direct loan authority for historical uses, defined at 46 U.S.C. 53701(8). Thus, NMFS anticipates that the balance of annual direct loan authority—currently $41 million—may be available to finance or refinance the purchase of harvesting rights in federally managed fisheries under a limited access system. This action will allow NMFS to fully use the program's loan authority either for historical purposes or any authorized new purposes should it be determined that demand or lack of demand in either area would result in unused loan authority.

    Proposed Harvesting Rights Lending

    Lending for harvesting rights would follow existing FFP lending procedures and guidelines. Borrowers must be U.S. citizens or entities eligible to document a vessel for coastwise trade under 46 U.S.C. 50501, meet all general FFP requirements, and meet all requirements to hold the harvesting rights under the applicable FMP at the time of loan closing. The FFP may require additional lending conditions and security terms such as loan guarantees or security interests in other collateral to bring credit risk to acceptable levels. Affiliated businesses, the borrower's principals or majority shareholders, persons or entities with a financial interest in the borrower, or any individuals holding community property rights may also be required to provide a guaranty.

    In addition, all loan applicants are subject to background and credit investigations, which may include, but are not limited to, reviews for unresolved fishing violations, criminal background checks, delinquent debt investigations, and credit reports. Like other FFP loan programs, lending for harvesting rights is subject to a statutory loan limit of up to 80 percent of the actual cost of the transaction, set as the purchase price or, in the case of refinancing, the current market value. The FFP retains sole discretion to determine the transaction's actual cost or current market value.

    Harvesting rights loan amounts can carry up to a 25-year term and can be used to either purchase new rights or refinance the debt associated with the prior purchase(s) of harvesting rights. In addition to maintaining a 20 percent minimum equity stake, borrowers refinancing existing debt will only receive the lesser of the outstanding amount of debt to be refinanced or 80 percent of the current market value of the harvesting right.

    If a borrower seeking refinancing fails to have the requisite 20 percent equity stake (measured as the difference between the current market value of the primary collateral and the amount of the loan), that borrower will need to pay down debt to meet the required level. In addition, under FFP standards, borrowers are only eligible for refinancing if their initial purchase would have been eligible for financing. The program will refinance harvesting rights acquired prior to this regulation if the buyer's original purchase would have been eligible for FFP financing under the terms of this action.

    Prospective borrowers may apply for a loan through any of the NOAA Fisheries Service regional FFP offices (St. Petersburg, FL; Gloucester, MA; Seattle, WA). They must pay the appropriate application fee, set by 46 U.S.C. 53713(b) as one-half of one percent of the loan amount requested, which is made up of two parts. Half is the “filing fee,” and is nonrefundable when the FFP officially accepts the application. The other half, known as the “commitment fee,” becomes nonrefundable when the FFP executes and mails an Approval-in-Principle (AIP) letter to the applicant. The FFP may refund the commitment fee if the FFP declines the application or the application is withdrawn prior to the issuance of an AIP letter.

    Summary and Explanation of Proposed Regulatory Changes

    This proposed action would add the following section, as explained here.

    Harvesting Rights Loans (253.31)

    This new section provides regulatory provisions specific to the harvesting rights loans. At the time a borrower submits an application, he or she must satisfy the criteria listed in this new section in order to be eligible to receive financing under the program. The borrower must comply with any limitations on the quantity of harvesting rights that may be owned by one holder, as specified in the applicable FMP and implementing regulations. The FFP will not finance harvesting rights in excess of ownership limitations.

    Classification

    This proposed rule is published under the authority of, and is consistent with, Chapter 537 of Title 46 of the United States Code and the Magnuson-Stevens Act, as amended. The NMFS Assistant Administrator has determined that this proposed rule is consistent with Chapter 537 of Title 46 of the U.S. Code, the Magnuson-Stevens Act, as amended, and other applicable law, subject to further consideration after public comment.

    In addition to public comment about the proposed rule's substance, NMFS also seeks public comment on any ambiguity or unnecessary complexity from the language used in this proposed rule.

    NEPA

    NMFS has preliminarily determined that this rule qualifies to be categorically excluded from further NEPA review. This action is consistent with categories of activities identified in CE G7 of the Companion Manual for NOAA Administrative Order 216-6A, and we have not identified any extraordinary circumstances that would preclude this categorical exclusion. NMFS is accepting comments and information during the public comment period for the proposed rule relevant to our preliminary categorical exclusion determination.

    Executive Order 12866

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

    This proposed rule does not duplicate, overlap, or conflict with any other relevant Federal rules.

    Paperwork Reduction Act

    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 OMB Control Number.

    This proposed rule contains collections-of-information subject to the PRA, which have been approved by OMB under control number 0648-0012. The application requirements contained in these rules have been approved under OMB control number 0648-0012. Public reporting burden for placing an application for FFP financing is estimated to average eight hours per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.

    Send comments regarding this burden estimate, or any other aspect of this data collection, including suggestions for reducing the burden, to NMFS (see ADDRESSES) and by email to [email protected] or fax to (202) 395-7285.

    Regulatory Flexibility Act

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

    The Regulatory Flexibility Act (RFA), 5 U.S.C. 601, et seq., requires that, “[w]henever an agency is required by section 553 of this title [5 USCS § 553], or any other law, to publish general notice of proposed rulemaking for any proposed rule, or publishes a notice of proposed rulemaking for an interpretative rule involving the internal revenue laws of the United States, the agency shall prepare and make available for public comment an initial regulatory flexibility analysis. Such analysis shall describe the impact of the proposed rule on small entities.” 5 U.S.C. 603(a). However, where an agency can certify “that the rule will not, if promulgated, have a significant economic impact on a substantial number of small entities” then an agency need not undertake a full regulatory flexibility analysis. 5 U.S.C. 605(b).

    Participation in the FFP is entirely voluntary. This action imposes no mandatory requirements on any business. Once final, this proposed rule will implement programs authorized by law. Specifically, these rules enact regulatory additions to create a new lending purpose authorized by Section 302 of the Coast Guard Authorization Act of 2015 (Pub. L. 114-120) and will be implemented in accordance with 50 CFR part 253, subpart B. This action will create new § 253.31.

    As defined by NMFS for RFA purposes, this rule may affect small fishing entities that have annual revenues of $11.0 million or less, including, but not limited to, vessel owners, vessel operators, individual fishermen, small corporations, and others engaged in commercial fishing activities regulated by NOAA. Borrowers under this authority may also include large businesses. Notably, because the FFP is a voluntary program that provides loans to qualified borrowers, non-borrowers—large or small—would not be regulated by this rule.

    Although the FFP requires certain supporting documentation during the life of a loan, the requirements do not impose unusual burdens when compared to the burdens imposed by other lenders. Moreover, because the basic need for financing would continue to exist without the FFP, the individuals seeking financing would still need to comply with similar, if not identical, requirements imposed by another lender. Records required to participate in the FFP are usually within the normal records already maintained by fishermen. It should take fewer than eight hours per application to meet these requirements.

    The information required from borrowers, such as income tax returns, insurance policies, permits, licenses, etc., is already available to them. Depending on circumstances, the FFP may require other supporting documents, including financial statements, property descriptions, and other documents that can be acquired at reasonable cost if they are not already available.

    FFP lending is a source of long-term, fixed rate capital financing and imposes no regulatory requirements on anyone other than those applying for loans. FFP borrowers make a voluntary decision to use the available lending.

    These loan programs will only have positive impacts on borrowers. Because participation is voluntary and requires effort and the outlay of an application fee, borrowers for harvesting rights financing are assumed to have made a determination that using FFP financing provides a benefit, such that the FFP's long-term, fixed rate financing provides only a positive economic impact. Importantly, the FFP does not regulate or manage the affairs of its borrowers, and the regulations impose no additional compliance, operating or other fees or costs on small entities other than a financing relationship would require.

    As a result of this certification, an initial regulatory flexibility analysis is not required and none has been prepared.

    List of Subjects in 50 CFR Part 253

    Aquaculture, Community development groups, Direct lending, Financial assistance, Fisheries, Fishing, Individual fishing quota, harvesting rights (privileges).

    Dated: October 25, 2017. Samuel D. Rauch, III, Deputy Assistant Administrator for Regulatory Programs, National Marine Fisheries Service.

    For the reasons set forth in the preamble, NMFS proposes to amend 50 CFR part 253, subpart B, as follows:

    PART 253—FISHERIES ASSISTANCE PROGRAMS Subpart B—Fisheries Finance Program 1. The authority citation for part 253 continues to read as follows: Authority:

    46 U.S.C. 53701 and 16 U.S.C. 4101 et seq.

    2. Section 253.31 is added to read as follows:
    § 253.31 Harvesting rights loans.

    (a) Specific definitions. For the purposes of this section, the following definitions apply:

    (1) Harvesting right(s) means any privilege to harvest fish in a fishery that is federally managed under a limited access system.

    (2) Limited access system has the same meaning given to that term in section 3 of the Magnuson-Stevens Fishery Conservation and Management Act (16 U.S.C. 1802).

    (3) [Reserved]

    (b) Loan Requirements and Limitations. These loan requirements and limitations apply to individuals or entities who seek to finance or refinance the acquisition of harvesting rights.

    (1) The borrower must meet all regulatory and statutory requirements to hold the harvesting rights at the time any such loan or refinancing loan would close.

    (2) NMFS will accept and consider the input of a Regional Fishery Management Council at any time regarding the availability of loans in a fishery under the Council's authority.

    (i) The Council may submit an explanation to NMFS, in writing, as to why the availability of financing for harvesting rights in a fishery would harm the achievement of the goals and objectives of the Fishery Management Plan applicable to the fishery. If NMFS accepts the Council's reasoning, harvesting rights loans will not be provided, or will cease to be provided, in that fishery.

    (ii) If NMFS determines that harvesting rights loans will not be provided in a fishery, NMFS will publish a notice in the Federal Register notifying the public that new loans will not be made in that fishery.

    (iii) In such a scenario, pending applications will be returned and loan fees returned as exceptional circumstances justify the action.

    (3) The harvesting rights to be financed must be issued in a manner in which they can be individually identified such that a valid and specific security interest can be recorded. This determination shall be solely made by the Program.

    (c) Refinancing. (1) The Program may refinance any existing debts associated with harvesting rights a borrower currently holds, provided that:

    (i) The harvesting rights being refinanced would have been eligible for Program financing at the time the borrower purchased them, if Program financing had been available,

    (ii) The borrower meets all other applicable lending requirements, and

    (iii) The refinancing is in an amount up to 80 percent of the harvesting rights' current market value, as determined at the sole discretion of the Program, and subject to the limitation that the Program will not disburse any amount that exceeds the outstanding principal balance, plus accrued interest (if any), of the existing harvesting rights' debt being refinanced or its fair market value, whichever is less.

    (2) In the event that the current market value of harvesting rights and principal loan balance do not meet the 80 percent requirement in paragraph (1)(iii) of this section, borrowers seeking refinancing may be required to provide additional down payment.

    (d) Maturity. Loan maturity may not exceed 25 years, but may be shorter depending on credit and other considerations.

    (e) Repayment. Repayment will be by equal quarterly installments of principal and interest.

    (f) Security. Although harvesting right(s) will be the primary collateral for a loan, the Program may require additional security pledges to maintain the priority of the Program's security interest. The Program, at its option, may also require all parties with significant ownership interests to personally guarantee loan repayment for any borrower that is a corporation, partnership, or other entity, including collateral to secure the guarantees. Some projects may require additional security, collateral, or credit enhancement as determined, in the sole discretion, by the Program.

    (g) Program credit standards. Harvesting rights loans, regardless of purpose, are subject to all Program general credit standards and requirements. Collateral, guarantee and other requirements may be adjusted to individual credit risks.

    [FR Doc. 2017-23570 Filed 10-30-17; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 660 [Docket No. 170817773-7905-1] RIN 0648-BG81 Fisheries Off West Coast States; Highly Migratory Fisheries; California Drift Gillnet Fishery; Implementation of a Federal Limited Entry Drift Gillnet Permit AGENCY:

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

    ACTION:

    Proposed rule; request for comments.

    SUMMARY:

    NMFS is proposing regulations under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (MSA) to implement a March 2017 recommendation by the Pacific Fishery Management Council (Council) to amend the Fishery Management Plan for U.S. West Coast Fisheries for Highly Migratory Species (HMS FMP). The proposed rule would bring the State of California's limited entry (LE) drift gillnet (DGN) permit program under MSA authority. All current California DGN permit holders would be eligible to apply for, and receive, a Federal DGN permit, and no additional DGN permits would be created. The proposed rule is administrative in nature and is not anticipated to result in increased activity, effort, or capacity in the fishery.

    DATES:

    Comments on the proposed rule and supporting documents must be submitted in writing on or before December 15, 2017.

    ADDRESSES:

    You may submit comments on this document, identified by NOAA-NMFS-2017-0052, 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-2017-0052, click the “Comment Now!” icon, complete the required fields, and enter or attach your comments.

    Mail: Submit written comments to Lyle Enriquez, NMFS West Coast Region, 501 W. Ocean Blvd., Suite 4200, Long Beach, CA 90802. Include the identifier “NOAA-NMFS-2017-0052” 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).

    Written comments regarding the burden-hour estimates or other aspects of the collection-of-information requirements contained in this proposed rule may be submitted to the West Coast Regional Office and by email to [email protected] or fax to (202) 395-5806.

    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-2017-0052 or by contacting the Regional Administrator, Barry Thom, NMFS West Coast Region, 1201 NE Lloyd Blvd., Portland, OR 97232-2182, or [email protected]

    FOR FURTHER INFORMATION CONTACT:

    Lyle Enriquez, NMFS, West Coast Region, 562-980-4025, or [email protected]

    SUPPLEMENTARY INFORMATION:

    The HMS FMP was prepared by the Council and is implemented under the authority of the MSA by regulations at 50 CFR part 660. Although it adopted all conservation and management measures in place under various Federal statutes (e.g., the Marine Mammal Protection Act and the Endangered Species Act) and state regulations, the HMS FMP did not incorporate the LE DGN permit programs of California and Oregon. Currently, the large-mesh DGN fishery (14” minimum mesh size) is Federally managed under the HMS FMP and via regulations of the states of California and Oregon to conserve target and non-target stocks, including protected species that are incidentally captured. (California has an active LE DGN program, Oregon no longer issues DGN permits, and DGN fishing is prohibited in Washington.)

    Since 2014, the Council has considered transitioning California's LE DGN permit program from state to MSA authority. On March 12, 2017, the Council adopted a final preferred alternative that would amend the HMS FMP and transition the State of California LE DGN permit program from state management to Federal management under MSA authority and entitle all fishermen authorized to fish with large-mesh DGN gear under state law to be eligible to receive a Federal LE DGN permit. As of August 31, 2017, 70 California LE DGN permits were issued for the 2016-2017 fishing season, and 67 have been renewed for the 2017-2018 fishing season. The average number of active DGN vessels per year from 2010 through 2016 is 20 vessels. The action would neither increase capacity within the DGN fishery, nor would it incentivize or stimulate fishing effort or activity of current latent permits. After the initial issuance of Federal DGN permits, no additional permits would be issued, and permits that are not renewed in future years would permanently expire. NMFS would not reissue the expired permits.

    In order to participate in the DGN fishery, current participants must possess a State of California LE DGN permit, a California commercial fishing license, a California general gill/trammel net permit, and a California swordfish permit. Additionally, the vessel that the participant fishes from must have a Federal Pacific Highly Migratory Species (HMS) permit with a DGN gear endorsement. After the LE DGN permit transitions from the State of California to Federal management, each participant will need to hold all the same permits and licenses, except that the Federal LE DGN permit will take the place of the State of California LE DGN permit. Although these permits and licenses would be required to fish, possession of a current and up-to-date State of California LE DGN permit is the only permit required to initially obtain a Federal LE DGN permit.

    This proposed rule would adopt many of the current State of California management measures associated with the fishery. For example, NMFS would adopt current California requirements regarding the assignment of a permit (i.e., permits would be issued to an individual and assigned to a specific vessel), the transfer of permits between permit holders (i.e., a permit must be held for three years before it is eligible to be transferred), and an annual renewal cycle.

    Upon the date of publication of the final rule, all 70 state-eligible permit holders would be eligible to receive a Federal DGN permit if they have renewed their state DGN permit by March 31, 2018. Permit holders who fail to renew their state DGN permit by March 31, 2018, will not be eligible for a Federal DGN permit. As of August 31, 2017, 67 permit holders have renewed their state LE DGN permit. If a state LE DGN permit is transferred after publication of the proposed rule, the transferee, but not the transferor, would be eligible to receive a Federal LE DGN permit upon publication of the final rule.

    Federal LE DGN permits would be issued annually for the fishing year starting April 1 and ending March 31 of the following year. Permits would expire on March 31 of each year and, after initial issuance (expected in 2018), the permit renewal deadline would be April 30 of each fishing year. A completed DGN permit renewal form must be received by NMFS no later than close-of-business April 30. Any renewal form received after that date would result in the permanent expiration of the Federal DGN permit. A permit owner who fails to submit a renewal form by the deadline may submit a renewal form to NMFS with a written statement that the failure to renew the permit by the deadline was proximately caused by the permit owner's illness or injury. When a permit owner has died, the owner's estate or other personal representative may submit a statement explaining that the permit owner's death has prevented a timely renewal. The permit holder, or in the case of a deceased permit owner, the estate or other personal representative, will need to provide written proof of illness, injury or death. NMFS will not consider any such renewal request made after July 31. A permit holder would need to hold a Federal LE DGN permit for a vesting period of at least three years before it would be eligible to be transferred. This vesting period would extend across both state and Federal permit programs (i.e., if a permit holder held a state LE DGN permit for two years and a Federal LE DGN permit for one year, the permit may be transferred).

    This proposed rule also includes technical edits to existing regulatory text. These edits add the word “general” before instances of “HMS permit” to distinguish the existing HMS permit from the new LE DGN permit; update a web address from which permit applications may be obtained; update the reference to the NMFS “Southwest Region” to refer to the West Coast Region, into which it was incorporated; and update the description of the NMFS regional “Sustainable Fisheries Division” to describe it as part of the West Coast Region.

    Classification

    Pursuant to section 304 (b)(1)(A) of the MSA, the NMFS West Coast Regional Administrator has determined that this proposed rule is consistent with the HMS FMP, other provisions of the MSA, and other applicable law, subject to further consideration after public comment.

    This proposed rule has been determined to be not significant for purposes of Executive Order 12866. This proposed rule is not an Executive Order 13771 regulatory action because this proposed rule is not significant under Executive Order 12866.

    This proposed rule contains a collection-of-information requirement subject to the Paperwork Reduction Act (PRA) and which has been approved by OMB under control number 0648-0204. Public reporting burden for the additional collection of information is estimated to average thirty minutes per form, including time for reviewing instructions, gathering the information needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate, or any other aspect of this data collection, including suggestions for reducing the burden, to NMFS (see ADDRESSES) and by email to [email protected], or fax to (202) 395-5806.

    Notwithstanding any other provision of the law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the PRA, unless that collection of information displays a currently valid OMB Control Number. All currently approved NOAA collections of information may be viewed at: http://www.cio.noaa.gov/services_programs/prasubs.html.

    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 proposed rule is administrative in nature and adopts current State of California permit requirements as they relate to the DGN fishery. This action is not expected to increase capacity, incentivize or stimulate fishing effort or activity of current latent permits, or change current fishing practices.

    For Regulatory Flexibility Act (RFA) purposes only, NMFS has established a small business size standard for businesses, including their affiliates, whose primarily industry is commercial fishing (50 CFR 200.2). A business primarily involved in commercial fishing (NAICS 11411) is classified as a small business if it is independently owned and operated, is not dominant in its field of operation (including its affiliates), and its combined annual receipts are not in excess of $11 million for all of its affiliated operations worldwide. NMFS has determined that all current participants in the DGN fishery are small entities under the NMFS standard. The average ex-vessel revenue for the U.S. West Coast DGN fishery from 2011 to 2015 is $745,600, with an average of 20 vessels participating per year. Therefore, the average ex-vessel revenue per active participant is $37,280. The increase in administrative costs, if any, resulting from this action would be less than 1% of ex-vessel revenues per active participant. In addition, because each affected entity is a small business, there would be no disproportionate economic impacts between large and small entities.

    Currently, participants must possess a Federal Pacific Highly Migratory Species (HMS) permit ($30), as well as a State of California commercial fishing license ($136.99), a California general gill/trammel net permit ($469.25), and a California LE DGN permit ($469.25) that includes a swordfish permit for fishing with hook-and-line or harpoon. If a fisherman does not participate in the DGN fishery, but participates in the harpoon or hook-and-line fishery, they must purchase a swordfish permit for $469.25. If this action is implemented, fishermen would receive a Federal LE DGN permit. The fee for a Federal LE DGN permit would be determined by only the administrative cost of issuing the permit, and it is expected that the Federal LE DGN permit would cost less than $100, which is far less than the California LE DGN permit cost of $469.25. There are three likely scenarios associated with implementing a Federal LE DGN permit, discussed below; in each scenario, the economic effects are not significant, as they would lead to either a reduction in costs or an insignificant increase in costs.

    In the first scenario, fishermen would acquire a Federal LE DGN permit. If the State of California does not amend its regulations and continues to require that fishermen purchase a State of California LE DGN permit (with the swordfish permit included), the cost increase would be only the additional cost of the Federal LE DGN permit. In the second scenario, if fishermen purchase a Federal LE DGN permit and state regulations are amended to no longer require the State of California LE DGN permit, but either a swordfish permit is still required or fishermen continue participating in the harpoon or hook-and-line fishery, there would be a cost increase equal to the cost of the Federal LE DGN permit, while the savings from not purchasing the state LE DGN permit would be offset by the cost of purchasing the swordfish permit. In the third scenario, if fishermen purchase a Federal LE DGN permit, a state LE DGN permit is no longer required, and either a swordfish permit is not required or fishermen do not participate in the harpoon or hook-and-line fishery, the fishermen would realize a cost savings, and the amount of cost savings would equal the difference between the cost of the state LE DGN permit ($469.25) and the cost of the Federal LE DGN permit (expected to be less than $100).

    As noted above, all entities subject to this action are considered small entities for RFA purposes. Based on the analysis provided above, the proposed action, if adopted, would not have a significant adverse economic impact on these small business entities. As a result, an initial regulatory flexibility analysis is not required and none has been prepared.

    List of Subjects in 50 CFR Part 660

    Fisheries, Fishing, Reporting, and recordkeeping requirements.

    Dated: October 25, 2017. Samuel D. Rauch, III, Deputy Assistant Administrator for Regulatory Programs, National Marine Fisheries Service.

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

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

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

    2. In § 660.702, revise the definition of “Sustainable Fisheries Division” to read as follows:

    Sustainable Fisheries Division (SFD) means the Assistant Regional Administrator for Sustainable Fisheries, West Coast Region, NMFS, or his or her designee.

    3. In § 660.707, revise paragraphs (a)(1), (a)(4), (b)(1), (b)(3), (b)(4), and (e), and add paragraph (f) to read as follows:
    § 660.707 Permits.

    (a) * * *

    (1) A commercial fishing vessel of the United States must be registered for use under a general HMS permit that authorizes the use of specific gear, and a recreational charter vessel must be registered for use under a HMS permit if that vessel is used:

    (i) To fish for HMS in the U.S. EEZ off the States of California, Oregon, and Washington; or

    (ii) To land or transship HMS shoreward of the outer boundary of the U.S. EEZ off the States of California, Oregon, and Washington.

    (4) Only a person eligible to own a documented vessel under the terms of 46 U.S.C. 12102(a) may be issued or may hold (by ownership or otherwise) a general HMS permit.

    (b) * * *

    (1) Following publication of the final rule implementing the FMP, NMFS will issue general HMS permits to the owners of those vessels on a list of vessels obtained from owners previously applying for a permit under the authority of the High Seas Fishing Compliance Act, the Tuna Conventions Act of 1950, the Marine Mammal Protection Act, and the Fishery Management Plan for Pelagic Fisheries of the Western Pacific Region, or whose vessels are listed on the vessel register of the Inter-American Tropical Tuna Commission.

    (3) An owner of a vessel subject to these requirements who has not received a permit under this section from NMFS and who wants to engage in the fisheries must apply to the SFD for the required permit in accordance with the following:

    (i) A West Coast Region Federal Fisheries application form may be obtained from the SFD or downloaded from the West Coast Region home page (http://www.westcoast.fisheries.noaa.gov/permits/commercial_fishing_research_permits.html) to apply for a permit under this section. A completed application is one that contains all the necessary information and signatures required.

    (ii) A minimum of 15 days should be allowed for processing a permit application. If an incomplete or improperly completed application is filed, the applicant will be sent a notice of deficiency. If the applicant fails to correct the deficiency within 30 days following the date of notification, the application will be considered abandoned.

    (iii) A permit will be issued by the SFD. If an application is denied, the SFD will indicate the reasons for denial.

    (iv) Appeals. (A) Any applicant for an initial permit may appeal the initial issuance decision to the Regional Administrator. To be considered by the Regional Administrator, such appeal must be in writing and state the reasons for the appeal, and must be submitted within 30 days of the action by the Regional Administrator. The appellant may request an informal hearing on the appeal.

    (B) Upon receipt of an appeal authorized by this section, the Regional Administrator will notify the permit applicant, or permit holder as appropriate, and will request such additional information and in such form as will allow action upon the appeal.

    (C) Upon receipt of sufficient information, the Regional Administrator will decide the appeal in accordance with the permit provisions set forth in this section at the time of the application, based upon information relative to the application on file at NMFS and the Council and any additional information submitted to or obtained by the Regional Administrator, the summary record kept of any hearing and the hearing officer's recommended decision, if any, and such other considerations as the Regional Administrator deems appropriate. The Regional Administrator will notify all interested persons of the decision, and the reasons for the decision, in writing, normally within 30 days of the receipt of sufficient information, unless additional time is needed for a hearing.

    (D) If a hearing is requested, or if the Regional Administrator determines that one is appropriate, the Regional Administrator may grant an informal hearing before a hearing officer designated for that purpose after first giving notice of the time, place, and subject matter of the hearing to the applicant. The appellant, and, at the discretion of the hearing officer, other interested persons, may appear personally or be represented by counsel at the hearing and submit information and present arguments as determined appropriate by the hearing officer. Within 30 days of the last day of the hearing, the hearing officer shall recommend in writing a decision to the Regional Administrator.

    (E) The Regional Administrator may adopt the hearing officer's recommended decision, in whole or in part, or may reject or modify it. In any event, the Regional Administrator will notify interested persons of the decision, and the reason(s) therefore, in writing, within 30 days of receipt of the hearing officer's recommended decision. The Regional Administrator's decision will constitute the final administrative action by NMFS on the matter.

    (F) Any time limit prescribed in this section may be extended for a period not to exceed 30 days by the Regional Administrator for good cause, either upon his or her own motion or upon written request from the appellant stating the reason(s) therefore.

    (4) General HMS permits issued under this subpart will remain valid until the first date of renewal, and permits may be subsequently renewed for 2-year terms. The first date of renewal will be the last day of the vessel owner's birth month in the second calendar year after the permit is issued (e.g., if the birth month is March and the permit is issued on October 3, 2007, the permit will remain valid through March 31, 2009).

    (e) Fees. An application for a permit, or renewal of an existing permit under this section will include a fee for each vessel. The fee amount required will be calculated in accordance with the NOAA Finance Handbook and specified on the application form.

    (f) Federal Limited Entry Drift Gillnet Permit.

    (1) General. This section applies to individuals fishing with large-mesh (14 inch or greater stretched mesh) drift gillnet (DGN) gear. Individuals who target, retain, transship, or land fish captured with a large-mesh DGN must possess a valid Federal limited entry DGN permit. Federal limited entry DGN permits are issued to an individual, and a vessel must be specified on the permit.

    (2) Initial Qualification. Upon publication of NMFS' final rule to establish the Federal limited entry DGN permit, all State of California limited entry DGN permit holders are eligible to obtain a Federal limited entry DGN permit. If a 2017-2018 California state DGN permit renewal application is not received by the California Department of Fish and Wildlife or postmarked by March 31, 2018, the permit holder is not eligible to receive a 2018-2019 Federal limited entry DGN permit.

    (3) Documentation and burden of proof. An individual applying for issuance, renewal, transfer, or assignment of a Federal limited entry DGN permit must prove that they meet the qualification requirements by submitting the following documentation, as applicable: A certified copy of the assigned vessel's documentation as a fishing vessel of the United States (U.S. Coast Guard or state) is the best evidence of vessel identification; a copy of a current State of California limited entry DGN permit is the best evidence of initial qualification for a Federal limited entry DGN permit; a copy of a written contract reserving or conveying limited entry rights is the best evidence of reserved or acquired rights; and other relevant, credible evidence that the applicant may wish to submit or that the SFD may request or require.

    (4) Fees. Any processing fee will be determined by the service costs needed to process a permit request. If a fee is required, it would cover administrative expenses related to issuing limited entry permits, as well as renewing, transferring, assigning, and replacing permits. The amount of any fee will be calculated in accordance with the procedures of the NOAA Finance Handbook for determining the administrative costs of each special product or service. A fee may not exceed such costs and is specified with each application form. The appropriate fee must accompany each application.

    (5) Initial decisions. (i) The SFD will make initial decisions regarding issuing, renewing, transferring, and assigning limited entry permits.

    (ii) Adverse decisions shall be in writing and shall state the reasons for the adverse decision.

    (iii) The SFD may decline to act on an application for issuing, renewing, transferring, or assigning a limited entry permit and will notify the applicant, if the permit sanction provisions of the Magnuson-Stevens Act at 16 U.S.C. 1858(a) and implementing regulations at 15 CFR part 904, subpart D, apply.

    (6) Issuance. Federal limited entry DGN permits will be issued by the SFD. If an application is denied, the SFD will indicate the reasons for denial. A DGN permit will be issued to an individual and assigned to a specific vessel. A permit holder may assign the permit to another vessel once per permit year (April 1 to March 31).

    (7) Appeals. Any applicant for an initial permit may appeal the initial issuance decision to the Regional Administrator. Appeals will be made and processed following procedures as described at paragraph (b)(3)(iv) of this section.

    (8) Transfers. Federal limited entry DGN permits may be transferred to another individual only if the current permit holder has held the Federal DGN permit for a minimum of three consecutive years (counted April 1 to March 31 of the following year). At the time of the establishment of the Federal limited entry DGN permit system, the length of time an individual has held a State of California limited entry DGN permit carries over (e.g., if an individual has held a California DGN permit for two years, they are eligible to transfer the Federal DGN permit after holding the Federal DGN permit for one year). Exceptions to this limitation on permit transfer may be made under the following circumstances:

    (i) The permit holder suffers from a serious illness or permanent disability that prevents the permit holder from earning a livelihood from commercial fishing.

    (ii) If a deceased permit holder's estate or heirs submit a transfer request within six months of the permit holder's death.

    (iii) Upon dissolution of marriage if the permit is held as community property.

    (9) Renewals. (i) The SFD will send notices to renew limited entry permits to the most recent address of the permit holder on file.

    (ii) The permit owner is responsible for renewing a limited entry permit.

    (iii) The deadline for receipt or postmark of a Federal DGN permit renewal application is April 30 of the permit year (i.e., April 30, 2019 for 2019-2020 fishing season). Federal DGN permits must be renewed yearly.

    (iv) A DGN permit that is allowed to expire will not be renewed unless the permit owner requests reissuance by July 31 (three months after the renewal application deadline) and NMFS determines that failure to renew was proximately caused by illness, injury, or death of the permit owner. If the permit expires, it will be forfeited and NMFS will not reissue the permit to anyone.

    (10) Owner on-board requirement. (i) Except as provided in paragraphs (ii) through (v), the DGN permit holder must be on-board the vessel and in possession of a valid Federal limited entry DGN permit when engaged in DGN fishing activity.

    (ii) A permit holder may designate another individual to fish under their permit for up to 15 days per fishing year (April 1 to March 31 of the following year); the substitute must comply with all other Federal permitting requirements. A permit holder shall notify NMFS of a substitution at least 24 hours prior to the commencement of the trip.

    (iii) If the person who owns a Federal DGN permit is prevented from being on-board a fishing vessel because the person died, is ill, or is injured, NMFS may allow an exemption to the owner on-board requirement for more than 15 days. The person requesting the exemption must send a letter to NMFS requesting an exemption from the owner on-board requirements, with appropriate evidence as described at paragraph (f)(10)(iv) or (v) of this section. All exemptions for death, injury, or illness will be evaluated by NMFS and a decision will be made in writing to the permit owner (or, in the case of the death of the permit owner, to the estate or heirs of the permit owner) within 60 calendar days of receipt of the original exemption request.

    (iv) Evidence of death of the permit owner shall be provided to NMFS in the form of a copy of a death certificate. In the interim before the estate is settled, if the deceased permit owner was subject to the owner on-board requirements, the estate of the deceased permit owner may send a letter to NMFS with a copy of the death certificate, requesting an exemption from the owner-on-board requirements. An exemption due to death of the permit owner will be effective only until such time that the estate of the deceased permit owner has registered the deceased permit owner's permit to a beneficiary, transferred the permit to another owner, or three years after the date of death as proven by a death certificate, whichever is earliest. An exemption from the owner-on-board requirement will be conveyed in a letter from NMFS to the estate of the permit owner and is required to be on the vessel during DGN fishing operations.

    (v) Evidence of illness or injury that prevents the permit owner from participating in the fishery shall be provided to NMFS in the form of a letter from a certified medical practitioner. This letter must detail the relevant medical conditions of the permit owner and how those conditions prevent the permit owner from being on-board a fishing vessel during DGN fishing. An exemption due to injury or illness will be effective only for the fishing year of the request for exemption. In order to extend a medical exemption for a succeeding year, the permit owner must submit a new request and provide documentation from a certified medical practitioner detailing why the permit owner is still unable to be on-board a fishing vessel. An exemption from the owner-on-board requirement will be conveyed in a letter from NMFS to the permit owner and is required to be on the vessel during DGN fishing operations.

    [FR Doc. 2017-23571 Filed 10-30-17; 8:45 am] BILLING CODE 3510-22-P
    82 209 Tuesday, October 31, 2017 Notices AGENCY FOR INTERNATIONAL DEVELOPMENT Notice of Public Information Collection Requirements Submitted to OMB for Review SUMMARY:

    U.S. Agency for International Development (USAID) has submitted the following information collection to OMB for review and clearance under the Paperwork Reduction Act of 1995.

    DATES:

    Comments regarding this information collection are best assured of having their full effect if received by November 30, 2017.

    ADDRESSES:

    Comments should be addressed to: Desk Officer for USAID, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), 725 17th Street NW., Washington, DC 20503 or email address: OIRA [email protected]

    Copies of submission may be obtained by calling (202) 712-5007.

    SUPPLEMENTARY INFORMATION:

    OMB Number: OMB 0412-XXXX.

    Form Number: AID Form 507-1.

    Title: Certification of Identity Form.

    Type: Renewal and from name change for Information Collection.

    Purpose: The purpose of the collection is to enable the U.S. Agency for International Development to locate applicable records and to respond to requests made under the Freedom of Information Act and the Privacy Act of 1974. Information includes sufficient personally identifiable information and/or source documents as applicable. Failure to provide the required information may result in no action being taken on the request. Authority to collect this information is contained in 5 U.S.C. 552, 5 U.S.C. 552a, and 22 CFR 215.4.

    Annual Reporting Burden:

    Respondents: 600.

    Total annual responses: 600.

    Total annual hours requested: 9,000.

    Dated: October 24, 2017. Paulette Murray, Supervisory, Records Information Management Specialist, Bureau for Management Office of Management Services, Information and Records Division.
    [FR Doc. 2017-23523 Filed 10-30-17; 8:45 am] BILLING CODE 6116-01-P
    DEPARTMENT OF AGRICULTURE Submission for OMB Review; Comment Request October 25, 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 November 30, 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.

    Animal Plant and Health Inspection Service

    Title: Plants for Planting Regulation.

    OMB Control Number: 0579-0190.

    Summary of Collection: Under the Plant Protection Act (PPA) (7 U.S.C. 7701—et seq), the Secretary of Agriculture is authorized to prohibit or restrict the importation, entry, exportation, or movement in interstate commerce of plant pests and other articles, to prevent the introduction of plant pests into the United States. The regulations in 7 CFR part 319 prohibits or restricts the importation of certain plants and plants products into the United States to prevent the introduction of plant pests and noxious weeds. The regulations contained in “Subpart-Plants for Planting,” §§ 319.37 through 319.37-14, restrict, among other things, the importation of living plants, plant parts, and seed for propagation. The nursery stock regulations require the Animal and Plant Health Inspection Service (APHIS) to collect information from a variety of individuals who are involved in growing, exporting, and importing nursery stock.

    Need and Use of the Information: APHIS will collect information to ensure that plant pests are not introduced into the United States. The information APHIS collects serves as the supporting documentation needed to issue required PPQ forms and documents that allow importation of nursery stock. APHIS requires a permit for the restricted articles to ensure that plant pest and plant diseases are not introduced into the United States. APHIS uses this information to implement and invoke the requirements of the Plant Protection Act.

    Description of Respondents: Business or other for-profit; Federal Government.

    Number of Respondents: 44.

    Frequency of Responses: Reporting: On occasion.

    Total Burden Hours: 5,557.

    Ruth Brown, Departmental Information Collection Clearance Officer.
    [FR Doc. 2017-23572 Filed 10-30-17; 8:45 am] BILLING CODE 3410-34-P
    DEPARTMENT OF AGRICULTURE Forest Service Information Collection; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery AGENCY:

    Forest Service, USDA.

    ACTION:

    Notice; request for comment.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995, the Forest Service is seeking comments from all interested individuals and organizations on the extension with no revision of a currently approved information collection, Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery.

    DATES:

    Comments must be received in writing on or before January 2, 2018 to be assured of consideration. Comments received after that date will be considered to the extent practicable.

    ADDRESSES:

    Comments concerning this notice should be addressed to the Assistant Director—Directives and Regulations, Office of Regulatory and Management Services, Mail Stop 1150, USDA Forest Service, 1400 Independence Avenue SW., Washington, DC 20250. Comments also may be submitted via facsimile to (703) 605-1575, or by email to [email protected]

    Comments submitted in response to this notice may be made available to the public through relevant Web sites and upon request. For this reason, please do not include in your comments information of a confidential nature, such as sensitive personal information or proprietary information. If you send an email comment, 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. Please note that responses to this public comment request containing any routine notice about the confidentiality of the communication will be treated as public comments that may be made available to the public notwithstanding the inclusion of the routine notice.

    The public may inspect the draft supporting statement and/or comments received at Forest Service, USDA, 201 14th Street SW., Washington, DC 20250, 1st floor CE, during normal business hours. Visitors are encouraged to call ahead to (202) 205-1082 to facilitate entry to the building. The public may request an electronic copy of the draft supporting statement and/or any comments received be sent via return email. Requests should be emailed to [email protected]

    FOR FURTHER INFORMATION CONTACT:

    Nicholas DiProfio, Directives and Regulations Staff, Office of Regulatory and Management Services, by phone (202) 205-1082 or by email at [email protected] Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Relay Service (FRS) at 1-800-877-8339 twenty-four hours a day, every day of the year, including holidays.

    SUPPLEMENTARY INFORMATION:

    Title: Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery.

    OMB Number: 0596-0226.

    Expiration Date of Approval: 4/30/2018.

    Type of Request: Extension without change of a currently approved information collection.

    Abstract: This information collection activity provides a means to garner qualitative customer and stakeholder feedback in an efficient, timely manner, in accordance with the Agency's commitment to improve service delivery. By qualitative feedback we mean information that provides useful insights on perceptions and opinions, but are not statistical surveys that yield quantitative results that can be generalized to the population of study.

    This feedback will provide insights into customer or stakeholder perceptions, experiences and expectations, provide an early warning of issues with service, or focus attention on areas where communication, training or changes in operations might improve delivery of products or services. These collections will allow for ongoing, collaborative and actionable communications between the Agency and its customers and stakeholders. It will also allow feedback to contribute directly to the improvement of program management. The solicitation of feedback will target areas such as: Timeliness, appropriateness, accuracy of information, courtesy, efficiency of service delivery, and resolution of issues with service delivery. Responses will be assessed to plan and inform efforts to improve or maintain the quality of service offered to the public.

    If this information is not collected, vital feedback from customers and stakeholders on the Agency's services will be unavailable. The Agency will only submit a collection for approval under this generic clearance if it meets the following conditions:

    • The collections are voluntary;

    • The collections are low-burden for respondents (based on considerations of total burden hours, total number of respondents, or burden-hours per respondent) and are low-cost for both the respondents and the Federal Government;

    • The collections are noncontroversial and do not raise issues of concern to other Federal agencies;

    • Any collection is targeted to the solicitation of opinions from respondents who have experience with the program or may have experience with the program in the near future;

    • Personally identifiable information (PII) is collected only to the extent necessary and is not retained;

    • Information gathered is intended to be used only internally for general service improvement and program management purposes and is not intended for release outside of the agency (if released, the agency must indicate the qualitative nature of the information);

    • Information gathered will not be used for the purpose of substantially informing influential policy decisions; and

    • Information gathered will yield qualitative information; the collections will not be designed or expected to yield statistically reliable results or used as though the results are generalizable to the population of study. Feedback collected under this generic clearance provides useful information, but it does not yield data that can be generalized to the overall population.

    This type of generic clearance for qualitative information will not be used for quantitative information collections that are designed to yield reliably actionable results, such as monitoring trends over time or documenting program performance. Such data uses require more rigorous designs that address: The target population to which generalizations will be made, the sampling frame, the sample design (including stratification and clustering), the precision requirements or power calculations that justify the proposed sample size, the expected response rate, methods for assessing potential nonresponse bias, the protocols for data collection, and any testing procedures that were or will be undertaken prior to fielding the study. Depending on the degree of influence the results are likely to have, such collections may still be eligible for submission for other generic mechanisms that are designed to yield quantitative results.

    As a general matter, information collections will not result in any new system of records containing privacy information and will not ask questions of a sensitive nature, such as sexual behavior and attitudes, religious beliefs, and other matters that are commonly considered private.

    Type of Respondents: Individuals and Households, Business and Organizations, State, Local or Tribal Government.

    Estimate of Burden per Response: 1 to 60 Minutes.

    Estimated Annual Number of Respondents: 3,500,000.

    Estimated Annual Number of Responses per Respondent: 1.

    Estimated Total Annual Burden on Respondents: 875,000 hours.

    Comment is Invited:

    Comment is invited on: (1) Whether this collection of information is necessary for the stated purposes and the proper performance of the functions of the agency, including whether the information will have practical or scientific utility; (2) the accuracy of the agency's estimate of the burden of the collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

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

    Dated: October 25, 2017. Robert Velasco, Acting Deputy Chief, Business Operations.
    [FR Doc. 2017-23700 Filed 10-30-17; 8:45 am] BILLING CODE 3411-15-P
    COMMISSION ON CIVIL RIGHTS Notice of Public Meeting of the New York Advisory Committee for Discussion and Approval of the Draft Report of Broken Windows Policing AGENCY:

    U.S. Commission on Civil Rights.

    ACTION:

    Announcement of meeting.

    SUMMARY:

    Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act that the New York Advisory Committee (Committee) will hold a meeting on Thursday, November 9, 2017, at 12:00 p.m. (Eastern) for the purpose of a discussion and vote for approval on the draft report of Broken Windows Policing.

    DATES:

    The meeting will be held on Thursday, November 9, 2017, at 12:00 p.m. EST.

    Public Call Information: Dial: 877-852-6576, Conference ID: 9818903.

    FOR FURTHER INFORMATION CONTACT:

    David Barreras, DFO, at [email protected] or 312-353-8311.

    SUPPLEMENTARY INFORMATION:

    Members of the public can listen to the discussion. This meeting is available to the public through the following toll-free call-in number: 877-852-6576, conference ID: 9818903. Any interested member of the public may call this number and listen to the meeting. An open comment period will be provided to allow members of the public to make a statement as time allows. The conference call operator will ask callers to identify themselves, the organization they are affiliated with (if any), and an email address prior to placing callers into the conference room. Callers can expect to incur regular charges for calls they initiate over wireless lines, according to their wireless plan. The Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Persons with hearing impairments may also follow the proceedings by first calling the Federal Relay Service at 1-800-977-8339 and providing the Service with the conference call number and conference ID number.

    Members of the public are also entitled to submit written comments; the comments must be received in the regional office within 30 days following the meeting. Written comments may be mailed to the Midwestern Regional Office, U.S. Commission on Civil Rights, 55 W. Monroe St., Suite 410, Chicago, IL 60615. They may also be faxed to the Commission at (312) 353-8324, or emailed to David Barreras at [email protected] Persons who desire additional information may contact the Midwestern Regional Office at (312) 353-8311.

    Records generated from this meeting may be inspected and reproduced at the Midwestern Regional Office, as they become available, both before and after the meeting. Records of the meeting will be available via www.facadatabase.gov under the Commission on Civil Rights, New York Advisory Committee link https://www.facadatabase.gov/committee/committee.aspx?cid=265&aid=17. Persons interested in the work of this Committee are directed to the Commission's Web site, http://www.usccr.gov, or may contact the Midwestern Regional Office at the above email or street address.

    Agenda Welcome and Roll Call Discussion on Draft Report Future Plans and Actions Public Comment Adjournment David Mussatt, Supervisory Chief, Regional Programs Unit.
    [FR Doc. 2017-23575 Filed 10-30-17; 8:45 am] BILLING CODE 6335-01-P
    COMMISSION ON CIVIL RIGHTS Notice of Public Meeting of the Ohio Advisory Committee To Discuss the Committee's Next Topic of Civil Rights Study: Educational Funding in Ohio AGENCY:

    U.S. Commission on Civil Rights.

    ACTION:

    Announcement of meeting.

    SUMMARY:

    Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act that the Ohio Advisory Committee (Committee) will hold a meeting on Tuesday, November 21, 2017, at 12:00 p.m. EST for the purpose of discussing preparations for a study of Civil Rights and Educational Funding in Ohio.

    DATES:

    The meeting will be held on Tuesday, November 21, 2017, at 12:00 p.m. EST.

    Public Call Information: Dial: 877-604-9665, Conference ID: 8623758.

    FOR FURTHER INFORMATION CONTACT:

    Melissa Wojnaroski, DFO, at [email protected] or 312-353-8311.

    SUPPLEMENTARY INFORMATION:

    Members of the public can listen to the discussion. This meeting is available to the public through the following toll-free call-in number: 877-604-9665, conference ID: 8623758. Any interested member of the public may call this number and listen to the meeting. An open comment period will be provided to allow members of the public to make a statement as time allows. The conference call operator will ask callers to identify themselves, the organization they are affiliated with (if any), and an email address prior to placing callers into the conference room. Callers can expect to incur regular charges for calls they initiate over wireless lines, according to their wireless plan. The Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Persons with hearing impairments may also follow the proceedings by first calling the Federal Relay Service at 1-800-977-8339 and providing the Service with the conference call number and conference ID number.

    Members of the public are also entitled to submit written comments; the comments must be received in the regional office within 30 days following the meeting. Written comments may be mailed to the Midwestern Regional Office, U.S. Commission on Civil Rights, 55 W. Monroe St., Suite 410, Chicago, IL 60615. They may also be faxed to the Commission at (312) 353-8324, or emailed to Carolyn Allen at [email protected] Persons who desire additional information may contact the Midwestern Regional Office at (312) 353-8311.

    Records generated from this meeting may be inspected and reproduced at the Midwestern Regional Office, as they become available, both before and after the meeting. Records of the meeting will be available via www.facadatabase.gov under the Commission on Civil Rights, Ohio Advisory Committee link (https://facadatabase.gov/committee/meetings.aspx?cid=268). Select “meeting details” and “documents” to download. Persons interested in the work of this Committee are directed to the Commission's Web site, http://www.usccr.gov, or may contact the Midwestern Regional Office at the above email or street address.

    Agenda Welcome and Introductions Project Discussion: “Civil Rights and Education Funding in Ohio” Public Comment Future Plans and Actions Adjournment Dated: October 26, 2017. David Mussatt, Supervisory Chief, Regional Programs Unit.
    [FR Doc. 2017-23676 Filed 10-30-17; 8:45 am] BILLING CODE P
    DEPARTMENT OF COMMERCE Economic Development Administration Notice of Petitions by Firms for Determination of Eligibility To Apply for Trade Adjustment Assistance AGENCY:

    Economic Development Administration, U.S. Department of Commerce.

    ACTION:

    Notice and opportunity for public comment.

    SUMMARY:

    The Economic Development Administration (EDA) has received petitions for certification of eligibility to apply for Trade Adjustment Assistance from the firms listed below. Accordingly, EDA has initiated investigations to determine whether increased imports into the United States of articles like or directly competitive with those produced by each of these firms contributed importantly to the total or partial separation of the firm's workers, or threat thereof, and to a decrease in sales or production of each petitioning firm.

    SUPPLEMENTARY INFORMATION: List of Petitions Received by EDA for Certification of Eligibility To Apply for Trade Adjustment Assistance [10/10/2017 through 10/24/2017] Firm name Firm address Date accepted for
  • investigation
  • Product(s)
    Drake Specialties, LLC 221 Fourpark Road, Lafayette, LA 70507 10/16/2017 The firm manufactures safety spray shields designed to detect and temporarily contain leaks and sprays. Toolander Engineering, Inc 1110 Via Callejon, San Clemente, CA 92673 10/18/2017 The firm manufactures precision metal stampings and progressive dies and tooling. The firm also provides stamped part design services and secondary services, including welding and assembly. Artistic Manufacturing Corporation 602 3rd Street SW., Altoona, IA 50009 10/20/2017 The firm manufactures metal-plated church ware. Fox Laminating Company 84 Custer Street, West Hartford, CT 06110 10/24/2017 The firm manufactures custom laminated wood plaques and provides commercial film laminating and finishing services. Raining Rose, Inc 100 30th Street Drive SE., Cedar Rapids, IA 52403 10/24/2017 The firm manufactures body care products, such as lip balms.

    Any party having a substantial interest in these proceedings may request a public hearing on the matter. A written request for a hearing must be submitted to the Trade Adjustment Assistance for Firms Division, Room 71030, Economic Development Administration, U.S. Department of Commerce, Washington, DC 20230, no later than ten (10) calendar days following publication of this notice. These petitions are received pursuant to section 251 of the Trade Act 1974, as amended.

    Please follow the requirements set forth in EDA's regulations at 13 CFR 315.9 for procedures to request a public hearing. The Catalog of Federal Domestic Assistance official number and title for the program under which these petitions are submitted is 11.313, Trade Adjustment Assistance for Firms.

    Irette Patterson, Program Analyst.
    [FR Doc. 2017-23603 Filed 10-30-17; 8:45 am] BILLING CODE 3510-WH-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-823-816] Carbon and Alloy Steel Wire Rod From Ukraine: Preliminary Affirmative Determination of Sales at Less Than Fair Value AGENCY:

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

    SUMMARY:

    The Department of Commerce (the Department) preliminarily determines that carbon and alloy steel wire rod (wire rod) from Ukraine is being, or is likely to be, sold in the United States at less than fair value (LTFV). The period of investigation (POI) is January 1, 2016, through December 31, 2016.

    DATES:

    Applicable October 31, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Julia Hancock, Annathea Cook, or Courtney Canales, AD/CVD Operations, Office V, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-1394, (202) 482-0250, or (202) 482-4997, respectively.

    SUPPLEMENTARY INFORMATION: Background

    This preliminary determination is made in accordance with section 733(b) of the Tariff Act of 1930, as amended (the Act). The Department published the notice of initiation of this investigation on April 26, 2017.1 On August 21, 2017, the Department postponed the preliminary determination of this investigation and the revised deadline is now until October 24, 2017.2 For a complete description of the events that followed the initiation of this investigation, see the Preliminary Decision Memorandum.3 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, 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 are identical in content.

    1See Carbon and Alloy Steel Wire Rod from Belarus, Italy, the Republic of Korea, the Russian Federation, South Africa, Spain, the Republic of Turkey, Ukraine, United Arab Emirates, and United Kingdom: Initiation of Less-Than-Fair-Value Investigations, 82 FR 19207 (April 26, 2017) (Initiation Notice).

    2See Carbon and Alloy Steel Wire Rod from Italy, the Republic of Korea, the Republic of South Africa, Spain, the Republic of Turkey, Ukraine and the United Kingdom: Postponement of Preliminary Determinations in the Less-Than-Fair-Value Investigations, 82 FR 39564 (April 26, 2017).

    3See Memorandum, “Decision Memorandum for the Preliminary Determination in the Less-Than-Fair-Value Investigation of Carbon and Alloy Steel Wire Rod from Ukraine” dated concurrently with, and hereby adopted by, this notice (Preliminary Decision Memorandum).

    Scope of the Investigation

    The products covered by this investigation are wire rod from Ukraine. For a complete description of the scope of this investigation, see Appendix I.

    Scope Comments

    In accordance with the preamble to the Department's regulations,4 the Initiation Notice set aside a period of time for parties to raise issues regarding product coverage (i.e., scope).5 Certain interested parties commented on the scope of the investigation as it appeared in the Initiation Notice. For a summary of the product coverage comments and rebuttal responses submitted to the record for this investigation, and accompanying discussion and analysis of all comments timely received, see the Preliminary Scope Decision Memorandum.6 Since the issuance of the Preliminary Scope Decision Memorandum, certain parties submitted scope case briefs or scope rebuttal briefs.7 The Department will issue a final scope decision on the records of the wire rod investigations after considering those comments submitted in scope case and rebuttal briefs.

    4See Antidumping Duties; Countervailing Duties, Final Rule, 62 FR 27296, 27323 (May 19, 1997).

    5See Initiation Notice.

    6See Memorandum, “Carbon and Alloy Steel Wire Rod from Belarus, Italy, the Republic of Korea, the Russian Federation, South Africa, Spain, the Republic of Turkey, Ukraine, the United Arab Emirates, and the United Kingdom: Scope Comments Decision Memorandum for the Preliminary Determinations,” (Preliminary Scope Decision Memorandum) dated August 7, 2017.

    7See Preliminary Decision Memorandum.

    Methodology

    The Department is conducting this investigation in accordance with section 731 of the Act. Pursuant to section 776(a) and (b) of the Act, the Department has preliminarily relied upon facts otherwise available, with adverse inferences for ArcelorMittal Steel Kryvyi Rih (AMKR) and Public Joint Stock Company Yenakiieve Iron And Steel Works (Yenakiieve). The Department has preliminarily determined that Duferco S.A. (Duferco) was not the first in the supply chain to have knowledge that subject merchandise was destined for the U.S. and as such, has been deselected as a respondent in this proceeding. For further discussion, see the Preliminary Decision Memorandum.

    All-Others Rate

    Sections 733(d)(1)(A)(ii) and 735(c)(5)(A) of the Act provide that in the preliminary determination the Department shall determine an estimated all-others rate for all exporters and producers not individually examined. This rate shall be an amount equal to the weighted average of the estimated weighted-average dumping margins established for exporters and producers individually investigated, excluding any zero and de minimis margins, and any margins determined entirely under section 776 of the Act. Pursuant to section 735(c)(5)(B) of the Act, if the estimated weighted-average dumping margins established for all exporters and producers individually examined are zero, de minimis or determined based entirely on facts otherwise available, the Department may use any reasonable method to establish the estimated weighted-average dumping margin for all-other producers or exporters.

    The Department has preliminarily determined the estimated weighted-average dumping margin for each of the individually examined respondents under section 776 of the Act. Consequently, pursuant to section 735(c)(5)(B) of the Act, the Department's normal practice under these circumstances has been to calculate the “all-others” rate as a simple average of the alleged dumping margins from the petition.8

    8See, e.g., Notice of Preliminary Determination of Sales at Less Than Fair Value: Sodium Nitrite from the Federal Republic of Germany, 73 FR 21909, 21912 (April 23, 2008), unchanged in Notice of Final Determination of Sales at Less Than Fair Value: Sodium Nitrite from the Federal Republic of Germany, 73 FR 38986, 38987 (July 8, 2008), and accompanying Issues and Decision Memorandum at Comment 2; see also Notice of Final Determination of Sales at Less Than Fair Value: Raw Flexible Magnets from Taiwan, 73 FR 39673, 39674 (July 10, 2008); Steel Threaded Rod from Thailand: Preliminary Determination of Sales at Less Than Fair Value and Affirmative Preliminary Determination of Critical Circumstances, 78 FR 79670, 79671 (December 31, 2013), unchanged in Steel Threaded Rod from Thailand: Final Determination of Sales at Less Than Fair Value and Affirmative Final Determination of Critical Circumstances, 79 FR 14476, 14477 (March 14, 2014).

    Preliminary Determination

    The Department preliminarily determines that the following estimated weighted-average dumping margins exist:

    Exporter/producer Estimated
  • weighted-
  • average
  • dumping
  • margin
  • (percent)
  • ArcelorMittal Steel Kryvyi Rih 44.03 Public Joint Stock Company Yenakiieve Iron And Steel Works 44.03 All-Others 34.98
    Suspension of Liquidation

    In accordance with section 733(d)(2) of the Act, the Department will direct U.S. Customs and Border Protection (CBP) to suspend liquidation of entries of subject merchandise, as described in Appendix I, entered, or withdrawn from warehouse, for consumption on or after the date of publication of this notice in the Federal Register. Further, pursuant to section 733(d)(1)(B) of the Act and 19 CFR 351.205(d), the Department will instruct CBP to require a cash deposit equal to the estimated weighted-average dumping margin or the estimated all-others rate, as follows: (1) The cash deposit rate for the respondents listed above will be equal to the company-specific estimated weighted-average dumping margins determined in this preliminary determination; (2) if the exporter is not a respondent identified above, but the producer is, then the cash deposit rate will be equal to the company-specific estimated weighted-average dumping margin established for that producer of the subject merchandise; and (3) the cash deposit rate for all other producers and exporters will be equal to the all-others estimated weighted-average dumping margin.

    Disclosure

    Normally, the Department discloses to interested parties the calculations performed in connection with a preliminary determination within five days of any public announcement or, if there is no public announcement, within five days of the date of publication of the notice of preliminary determination in the Federal Register, in accordance with 19 CFR 351.224(b). However, because the Department preliminarily applied AFA to the individually examined companies, AMKR and Yenakiieve, in this investigation, in accordance with section 776 of the Act, and the applied AFA rate is based solely on the petition, there are no calculations to disclose.

    Verification

    Because the mandatory respondents in this investigation did not provide information requested by the Department, and the Department preliminarily determines that each has been uncooperative, we will not conduct verification.

    Public Comment

    Case briefs or other written comments may be submitted to the Assistant Secretary for Enforcement and Compliance no later than 50 days after the date of publication of the preliminary determination, 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 investigation 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.

    Final Determination

    Section 735(a)(1) of the Act and 19 CFR 351.210(b)(1) provide that the Department will issue the final determination within 75 days after the date of its preliminary determination. Accordingly, the Department will make its final determination no later than 75 days after the signature date of this preliminary determination.

    International Trade Commission

    In accordance with section 773(f) of the Act, the Department will notify the International Trade Comission (ITC) of its preliminary determination. If the final determination is affirmative, the ITC will determine before the later of 120 days after the date of this preliminary determination or 45 days after the final determination whether these imports are materially injuring, or threaten material injury to, the U.S. industry.

    Notification to Interested Parties

    This determination is issued and published in accordance with sections 733(f) and 777(i)(1) of the Act and 19 CFR 351.205(c).

    Dated: October 24, 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 Investigation

    The products covered by this investigation are certain hot-rolled products of carbon steel and alloy steel, in coils, of approximately round cross section, less than 19.00 mm in actual solid cross-sectional diameter. Specifically excluded are steel products possessing the above-noted physical characteristics and meeting the Harmonized Tariff Schedule of the United States (HTSUS) definitions for (a) stainless steel; (b) tool steel; (c) high-nickel steel; (d) ball bearing steel; or (e) concrete reinforcing bars and rods. Also excluded are free cutting steel (also known as free machining steel) products (i.e., products that contain by weight one or more of the following elements: 0.1 percent or more of lead, 0.05 percent or more of bismuth, 0.08 percent or more of sulfur, more than 0.04 percent of phosphorous, more than 0.05 percent of selenium, or more than 0.01 percent of tellurium). All products meeting the physical description of subject merchandise that are not specifically excluded are included in this scope.

    The products under investigation are currently classifiable under subheadings 7213.91.3011, 7213.91.3015, 7213.91.3020, 7213.91.3093; 7213.91.4500, 7213.91.6000, 7213.99.0030, 7227.20.0030, 7227.20.0080, 7227.90.6010, 7227.90.6020, 7227.90.6030, and 7227.90.6035 of the HTSUS. Products entered under subheadings 7213.99.0090 and 7227.90.6090 of the HTSUS also may be included in this scope if they meet the physical description of subject merchandise above. Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of the scope of this proceeding is dispositive.

    Appendix II List of Topics Discussed in the Preliminary Decision Memorandum I. Summary II. Background III. Period of Investigation IV. Scope Comments V. Preliminary Determination of No Shipments VI. Application of Facts Available and Adverse Inference A. Legal Standard B. Application of Facts Available with Adverse Inference for AMKR C. Application of Facts Available with Adverse Inference for Yenakiieve D. Selection and Corroboration of AFA Rate E. All-Others Rate VIII. Conclusion
    [FR Doc. 2017-23648 Filed 10-30-17; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-489-831] Carbon and Alloy Steel Wire Rod From Turkey: Preliminary Affirmative Determination of Sales at Less Than Fair Value, and Preliminary Negative Determination of Critical Circumstances AGENCY:

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

    SUMMARY:

    The Department of Commerce (the Department) preliminarily determines that certain carbon and alloy steel wire rod (wire rod) from the Republic of Turkey (Turkey) is being, or is likely to be, sold in the United States at less than fair value (LTFV). The period of investigation (POI) is January 1, 2016, through December 31, 2016.

    DATES:

    Applicable October 31, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Ryan Mullen or Ian Hamilton, AD/CVD Operations, Office V, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-5260 or (202) 482-4798, respectively.

    SUPPLEMENTARY INFORMATION: Background

    This preliminary determination is made in accordance with section 733(b) of the Tariff Act of 1930, as amended (the Act). The Department published the notice of initiation of this investigation on April 26, 2017.1 On August 21, 2017, the Department postponed the preliminary determination of this investigation until October 24, 2017.2 For a complete description of the events that followed the initiation of this investigation, see the Preliminary Decision Memorandum.3 A list of topics discussed 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, 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 are identical in content.

    1See Carbon and Alloy Steel Wire Rod from Belarus, Italy, the Republic of Korea, the Russian Federation, South Africa, Spain, the Republic of Turkey, Ukraine, United Arab Emirates, and United Kingdom: Initiation of Less-Than-Fair Value Investigations, 82 FR 19207 (April 26, 2017) (Initiation Notice).

    2See Carbon and Alloy Steel Wire Rod from Italy, the Republic of Korea, the Republic of South Africa, Spain, the Republic of Turkey, Ukraine and the United Kingdom: Postponement of Preliminary Determinations in the Less-Than-Fair-Value Investigations, 82 FR 39564 (August 21, 2017).

    3See Memorandum, “Decision Memorandum for the Preliminary Determination and Negative Determination of Critical Circumstances in the Less Than Fair Value Investigation of Carbon and Alloy Steel Wire Rod from Turkey,” dated concurrently with, and hereby adopted by, this notice (Preliminary Decision Memorandum).

    Scope of the Investigation

    The products covered by this investigation are wire rod from Turkey. For a complete description of the scope of this investigation, see Appendix I.

    Scope Comments

    In accordance with the preamble to the Department's regulations,4 the Initiation Notice set aside a period of time for parties to raise issues regarding product coverage (scope).5 Certain interested parties commented on the scope of the investigation as it appeared in the Initiation Notice. For a summary of the product coverage comments and rebuttal responses submitted to the record for this investigation, and accompanying discussion and analysis of all comments timely received, see the Preliminary Scope Decision Memorandum.6 Since the issuance of the Preliminary Scope Decision Memorandum, certain parties submitted scope case briefs or scope rebuttal briefs.7 The Department will issue a final scope decision on the records of the wire rod investigations after considering those comments submitted in scope case and rebuttal briefs.

    4See Antidumping Duties; Countervailing Duties, Final Rule, 62 FR 27296, 27323 (May 19, 1997).

    5See Initiation Notice, 82 FR at 19207-08.

    6See Memorandum, “Carbon and Alloy Steel Wire Rod from Belarus, Italy, the Republic of Korea, the Russian Federation, South Africa, Spain, the Republic of Turkey, Ukraine, the United Arab Emirates, and the United Kingdom: Scope Comments Decision Memorandum for the Preliminary Determinations,” dated August 7, 2017 (Preliminary Scope Decision Memorandum).

    7See Preliminary Decision Memorandum.

    Methodology

    The Department is conducting this investigation in accordance with section 731 of the Act. The Department has calculated export prices in accordance with section 772(a) of the Act. Normal value (NV) is calculated in accordance with section 773 of the Act. For a full description of the methodology underlying the preliminary conclusions, see the Preliminary Decision Memorandum.

    Preliminary Negative Determination of Critical Circumstances

    On July 6, 2017, the petitioners filed a critical circumstances allegation with respect to imports of wire rod from Turkey.8 In accordance with section 733(e) of the Act and 19 CFR 351.206, we preliminarily find that critical circumstances do not exist with respect to imports of wire rod from Turkey for Habas Sinai ve Tibbi Gazlar Istihsal Endustrisi A.S. (Habas), Icdas Celik Enerji Tersane ve Ulasim Sanayi A.S. (Icdas), and all-other exporters/producers of wire rod from Turkey. For a full description of the methodology and results of the Department's critical circumstances analysis, see the Preliminary Decision Memorandum.

    8See Letter to the Secretary from Nucor re: Carbon and Alloy Steel Wire Rod from Russia, South Africa, Spain, Turkey, and the United Kingdom: Critical Circumstances Allegations, dated July 6, 2017.

    All-Others Rate

    Sections 733(d)(1)(A)(ii) of the Act provides that in the preliminary determination the Department shall determine an estimated all-others rate for all exporters and producers not individually investigated in accordance with section 735(c)(5) of the Act. Section 735(c)(5)(A) of the Act states that generally this rate shall be an amount equal to the weighted average of the estimated weighted-average dumping margins established for exporters and producers individually investigated, excluding any zero and de minimis margins, and any margins determined entirely under section 776 of the Act.

    In this investigation, the Department calculated estimated weighted-average dumping margins for Habas and Icdas that are not zero, de minimis or based entirely on facts otherwise available. The Department calculated the all-others rate using a simple average of the estimated weighted-average dumping margins calculated for the examined respondents.9

    9 With two respondents under examination, the Department normally calculates (A) a weighted-average of the estimated weighted-average dumping margins calculated for the examined respondents; (B) a simple average of the estimated weighted-average dumping margins calculated for the examined respondents; and (C) a weighted-average of the estimated weighted-average dumping margins calculated for the examined respondents using each company's publicly-ranged U.S. sale quantities for the merchandise under consideration. The Department then compares (B) and (C) to (A) and selects the rate closest to (A) as the most appropriate rate for all other producers and exporters. See Ball Bearings and Parts Thereof from France, Germany, Italy, Japan, and the United Kingdom: Final Results of Antidumping Duty Administrative Reviews, Final Results of Changed-Circumstances Review, and Revocation of an Order in Part, 75 FR 53661, 53663 (September 1, 2010). For a complete analysis of the data, please see the All-Others' Rate Calculation Memorandum, dated concurrently with this notice.

    Preliminary Determination

    The Department preliminarily determines that the following weighted-average dumping margins exist:

    Exporter/producer Weighted-
  • average
  • margins
  • (percent)
  • Cash deposit rate adjusted for subsidy
  • offset
  • Habas Sinai ve Tibbi Gazlar Istihsal Endustrisi A.S 2.80 2.70 Icdas Celik Enerji Tersane ve Ulasim Sanayi A.S 8.01 8.01 All-Others 5.41 5.31
    Suspension of Liquidation

    In accordance with section 733(d)(2) of the Act, the Department will direct U.S. Customs and Border Protection (CBP) to suspend liquidation of entries of subject merchandise, as described in Appendix I, entered, or withdrawn from warehouse, for consumption on or after the date of publication of this notice in the Federal Register. Further, pursuant to section 733(d)(1)(B) of the Act and 19 CFR 351.205(d), the Department will instruct CBP to require a cash deposit equal to the estimated weighted-average dumping margin or the estimated all-others rate, as follows: (1) The cash deposit rate for the respondents listed above will be equal to the company-specific estimated weighted-average dumping margins determined in this preliminary determination; (2) if the exporter is not a respondent identified above, but the producer is, then the cash deposit rate will be equal to the company-specific estimated weighted-average dumping margin established for that producer of the subject merchandise; and (3) the cash deposit rate for all other producers and exporters will be equal to the all-others estimated weighted-average dumping margin.

    The Department normally adjusts cash deposits for estimated antidumping duties by the amount of export subsidies countervailed in a companion countervailing duty (CVD) proceeding, when CVD provisional measures are in effect. Accordingly, where the Department preliminarily made an affirmative determination for countervailable export subsidies, the Department offset the estimated weighted-average dumping margin by the appropriate CVD rate. The adjusted cash deposit rate may be found in the Preliminary Determination section above. Should provisional measures in the companion CVD investigation expire prior to the expiration of provisional measures in this LTFV investigation, the Department will direct CBP to begin collecting estimated antidumping duty cash deposits unadjusted for countervailed export subsidies at the time that the provisional CVD measures expire. These suspension of liquidation instructions will remain in effect until further notice.

    Disclosure

    The Department intends to disclose its calculations and analysis performed to interested parties in this preliminary determination within five days of any public announcement or, if there is no public announcement, within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b).

    Verification

    As provided in section 782(i) of the Act, the Department intends to verify the information relied upon in making its final determination.

    Public Comment

    Case briefs or other written comments may be submitted to the Assistant Secretary for Enforcement and Compliance no later than seven days after the date on which the final verification report is issued in this investigation. Rebuttal briefs, limited to issues raised in case briefs, may be submitted no later than five days after the deadline date for case briefs.10 Pursuant to 19 CFR 351.309(c)(2) and (d)(2), 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.

    10See 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.

    Final Determination

    Section 735(a)(1) of the Act and 19 CFR 351.210(b)(1) provide that the Department will issue the final determination within 75 days after the date of its preliminary determination. Accordingly, the Department will make its final determination no later than 75 days after the signature date of this preliminary determination.

    International Trade Commission Notification

    In accordance with section 733(f) of the Act, the Department will notify the International Trade Commission (ITC) of its preliminary affirmative determination. If the final determination is affirmative, the ITC will determine before the later of 120 days after the date of this preliminary determination or 45 days after the final determination whether these imports are materially injuring, or threaten material injury to, the U.S. industry.

    Notification to Interested Parties

    This determination is issued and published in accordance with sections 733(f) and 777(i)(1) of the Act and 19 CFR 351.205(c).

    Dated: October 24, 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 Investigation

    The products covered by this investigation are certain hot-rolled products of carbon steel and alloy steel, in coils, of approximately round cross section, less than 19.00 mm in actual solid cross-sectional diameter. Specifically excluded are steel products possessing the above-noted physical characteristics and meeting the Harmonized Tariff Schedule of the United States (HTSUS) definitions for (a) stainless steel; (b) tool steel; (c) high-nickel steel; (d) ball bearing steel; or (e) concrete reinforcing bars and rods. Also excluded are free cutting steel (also known as free machining steel) products (i.e., products that contain by weight one or more of the following elements: 0.1 percent or more of lead, 0.05 percent or more of bismuth, 0.08 percent or more of sulfur, more than 0.04 percent of phosphorous, more than 0.05 percent of selenium, or more than 0.01 percent of tellurium). All products meeting the physical description of subject merchandise that are not specifically excluded are included in this scope.

    The products under investigation are currently classifiable under subheadings 7213.91.3011, 213.91.3015, 7213.91.3020, 7213.91.3093; 7213.91.4500, 7213.91.6000, 7213.99.0030, 7227.20.0030, 7227.20.0080, 7227.90.6010, 7227.90.6020, 7227.90.6030, and 7227.90.6035 of the HTSUS. Products entered under subheadings 7213.99.0090 and 7227.90.6090 of the HTSUS also may be included in this scope if they meet the physical description of subject merchandise above. Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of the scope of this proceeding is dispositive.

    Appendix II List of Topics Discussed in the Preliminary Decision Memorandum I. Summary II. Background III. Period of Investigation IV. Scope Comments V. Discussion of the Methodology A. Determination of the Comparison Method B. Results of the Differential Pricing Analysis VI. Date of Sale VII. Product Comparisons VIII. Export Price IX. Normal Value A. Comparison Market Viability B. Affiliated-Party Transactions and Arm's-Length Test C. Level of Trade D. Cost of Production (COP) Analysis 1. Calculation of COP 2. Test of Comparison Market Sales Prices 3. Results of the COP Test E. Calculation of NV Based on Comparison Market Prices F. Calculation of NV Based on Constructed Value X. Preliminary Negative Determination of Critical Circumstances A. Legal Framework B. Critical Circumstances Allegation C. Analysis XI. Adjustment to Cash Deposit Rate for Export Subsidies XII. Currency Conversion XIII. Conclusion
    [FR Doc. 2017-23647 Filed 10-30-17; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-560-830] Biodiesel From Indonesia: Preliminary Affirmative Determination of Sales at Less Than Fair Value AGENCY:

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

    SUMMARY:

    The Department of Commerce (the Department) preliminarily determines that biodiesel from Indonesia is being, or is likely to be, sold in the United States at less than fair value (LTFV). The period of investigation (POI) is January 1, 2016, through December 31, 2016.

    DATES:

    Effective October 31, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Myrna Lobo or Alexander Cipolla, AD/CVD Operations, Office VII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-2371 or (202) 482-4956, respectively.

    SUPPLEMENTARY INFORMATION:

    Background

    This preliminary determination is made in accordance with section 733(b) of the Tariff Act of 1930, as amended (the Act). The Department published the notice of initiation of this investigation on April 19, 2017.1 For a complete description of the events that followed the initiation of this investigation, 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, 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 and the electronic versions of the Preliminary Decision Memorandum are identical in content.

    1See Biodiesel from Argentina and Indonesia: Initiation of Less-Than-Fair Value Investigations, 82 FR 18428 (April 19, 2017) (Initiation Notice).

    2See Memorandum, “Decision Memorandum for the Preliminary Determination in the Less-Than-Fair-Value Investigation of Biodiesel from Indonesia” dated concurrently with, and hereby adopted by, this notice (Preliminary Decision Memorandum).

    Scope of the Investigation

    The product covered by this investigation is biodiesel from Indonesia. For a complete description of the scope of this investigation, see Appendix I.

    Scope Comments

    In accordance with the preamble to the Department's regulations,3 the Initiation Notice set aside a period of time for parties to raise issues regarding product coverage (i.e., scope).4 No interested parties commented on the scope of the investigation as it appeared in the Initiation Notice. Therefore, the Department is preliminarily not modifying the scope language as it appeared in the Initiation Notice. See the scope in Appendix I to this notice.

    3See Antidumping Duties; Countervailing Duties, Final Rule, 62 FR 27296, 27323 (May 19, 1997).

    4See Initiation Notice, 82 FR at 18428-29.

    Methodology

    The Department is conducting this investigation in accordance with section 731 of the Act. The Department has calculated export prices in accordance with section 772(a) of the Act. Constructed export prices have been calculated in accordance with section 772(b) of the Act. Normal value (NV) is calculated in accordance with section 773 of the Act. In addition, the Department has relied on adverse facts available pursuant to sections 776(a) and (b) of the Act for PT Musim Mas (Musim Mas). For a full description of the methodology underlying the preliminary determination, see the Preliminary Decision Memorandum.

    Particular Market Situation

    On July 25, 2017, the National Biodiesel Board Fair Trade Coalition (petitioner) filed a particular market situation (PMS) allegation with respect to the respondents' home market sales prices and reported costs of production.5 The petitioner asserts that a PMS exists in Indonesia because the Government of Indonesia (GOI) sets low mandatory prices and sales quotas for biodiesel in the home market, and restrains the exports of crude palm oil (CPO) with an export tax and levy, thereby distorting the respondents' reported raw material CPO costs in Indonesia. The petitioner argues that the Department should disregard the respondents' home market sales based on a finding that they are significantly distorted by government intervention. The petitioner also urges the Department to make an adjustment for the cost of CPO purchased from domestic suppliers to address the distorted Indonesian market for CPO.

    5See Petitioner's Letter, “Biodiesel from Indonesia: Petitioner's Particular Market Situation Allegation Regarding Respondents' Home Market Sales and Costs of Produciton,” dated July 25, 2017.

    The respondents and the GOI argue that the prices set by the GOI are based on market prices, and the total compensation each respondent receives for sales of biodiesel in Indonesia reflects the full market value of its biodiesel. The respondents also contend that their sales that are not controlled by the government constitute a viable home market. Each respondent argues that the lower prices paid for CPO are not enough for a PMS finding, and that they should be examined in the context of the concurrent countervailing duty (CVD) investigation.

    Based on the facts on the record, the Department preliminarily finds that the GOI's regulation of the domestic biodiesel market amounts to a particular market situation in Indonesia that renders the home market prices of Wilmar Trading PTE Ltd. (Wilmar), the only respondent for which we are preliminarily calculating a weighted-average dumping margin, outside the ordinary course of trade. Therefore, the Department is preliminarily relying on constructed value (CV) as the basis for NV in this investigation for Wilmar. The Department also preliminarily finds that a PMS exists in Indonesia with regard to the cost of CPO as a component of the cost of manufacturing (COM) for biodiesel. Therefore, the Department has adjusted Wilmar's COM to account for the distorted cost of CPO. For a full description of the methodology underlying the PMS determination, see the Preliminary Decision Memorandum.

    All-Others Rate

    Sections 733(d)(1)(ii) and 735(c)(5)(A) of the Act provide that in the preliminary determination the Department shall determine an estimated all-others rate for all exporters and producers not individually examined. This rate shall be an amount equal to the weighted average of the estimated weighted-average dumping margins established for exporters and producers individually investigated, excluding rates that are zero, de minimis, or determined entirely on facts available under section 776 of the Act.

    In this investigation, the Department preliminarily assigned a rate based entirely on facts available to Musim Mas. Therefore, the only rate that is not zero, de minimis or based entirely on facts otherwise available is the rate calculated for Wilmar. Consequently, the rate calculated for Wilmar is also assigned as the rate for all-other producers and exporters.

    Preliminary Determination

    The Department preliminarily determines that the following estimated weighted-average dumping margins exist:

    6 The Department preliminarily determines that Wilmar Trading PTE Ltd., PT Wilmar Bioenergi Indonesia, PT Wilmar Nabati Indonesia, and PT Multi Nabati Sulawesi are affiliated pursuant to section 771(33)(F) of the Act and should be collapsed and treated as a single entity pursuant to 19 CFR 351.401(f). See Preliminary Decision Memorandum.

    Exporter or producer Estimated
  • weighted-
  • average
  • dumping
  • margin
  • (percent)
  • Wilmar Trading PTE Ltd 6 50.71 PT Musim Mas 50.71 All-Others 50.71
    Suspension of Liquidation

    In accordance with section 733(d)(2) of the Act, the Department will direct U.S. Customs and Border Protection (CBP) to suspend liquidation of entries of subject merchandise, as described in Appendix I, entered, or withdrawn from warehouse, for consumption on or after the date of publication of this notice in the Federal Register. Further, pursuant to section 733(d)(1)(B) of the Act and 19 CFR 351.205(d), the Department will instruct CBP to require a cash deposit equal to the estimated weighted-average dumping margin as follows: (1) The cash deposit rate for the respondents listed above will be equal to the company-specific estimated weighted-average dumping margins determined in this preliminary determination; (2) if the exporter is not a respondent identified above, but the producer is, then the cash deposit rate will be equal to the company-specific estimated weighted-average dumping margin established for that producer of the subject merchandise; and (3) the cash deposit rate for all other producers and exporters will be equal to the all-others estimated weighted-average dumping margin.

    The Department normally adjusts cash deposits for estimated antidumping duties by the amount of export subsidies countervailed in a companion CVD proceeding in accordance with section 772(c)(1)(C), when CVD provisional measures are in effect. Accordingly, where the Department preliminarily made an affirmative determination for countervailable export subsidies, the Department has offset the estimated weighted-average dumping margin by the appropriate CVD rate. In the preliminary determination in the companion CVD investigation, the Department found no countervailable export subsidies.7 Therefore, we preliminarily determine not to adjust the cash deposit rates in the Preliminary Determination.

    7See Biodiesel from the Republic of Indonesia: Preliminary Affirmative Countervailing Duty Determination, 82 FR 40746 (August 28, 2017), and accompanying Preliminary Decision Memorandum.

    These suspension of liquidation instructions will remain in effect until further notice.

    Disclosure

    The Department intends to disclose its calculations and analysis performed to interested parties in this preliminary determination within five days of any public announcement or, if there is no public announcement, within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b).

    Verification

    As provided in section 782(i)(1) of the Act, the Department intends to verify the information relied upon in making its final determination.

    Public Comment

    Case briefs or other written comments may be submitted to the Assistant Secretary for Enforcement and Compliance no later than seven days after the date on which the last verification report is issued in this investigation, 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.8 Pursuant to 19 CFR 351.309(c)(2) and (d)(2), parties who submit case briefs or rebuttal briefs in this investigation 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.

    8See 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.

    Final Determination

    Section 735(a)(1) of the Act and 19 CFR 351.210(b)(1) provide that the Department will issue the final determination within 75 days after the date of its preliminary determination. Accordingly, the Department will make its final determination no later than 75 days after the signature date of this preliminary determination, unless extended.

    International Trade Commission Notification

    In accordance with section 733(f) of the Act, the Department will notify the International Trade Commission (ITC) of its preliminary determination. If the final determination is affirmative, the ITC will determine before the later of 120 days after the date of this preliminary determination or 45 days after the final determination whether these imports are materially injuring, or threaten material injury to, the U.S. industry.

    Notification to Interested Parties

    This determination is issued and published in accordance with sections 733(f) and 777(i)(1) of the Act and 19 CFR 351.205(c).

    Dated: October 19, 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 Investigation

    The product covered by this investigation is biodiesel, which is a fuel comprised of mono-alkyl esters of long chain fatty acids derived from vegetable oils or animal fats, including biologically based waste oils or greases, and other biologically-based oil or fat sources. The investigation covers biodiesel in pure form (B100) as well as fuel mixtures containing at least 99 percent biodiesel by volume (B99). For fuel mixtures containing less than 99 percent biodiesel by volume, only the biodiesel component of the mixture is covered by the scope of the investigation.

    Biodiesel is generally produced to American Society for Testing and Materials International (ASTM) D6751 specifications, but it can also be made to other specifications. Biodiesel commonly has one of the following Chemical Abstracts Service (CAS) numbers, generally depending upon the feedstock used: 67784-80-9 (soybean oil methyl esters); 91051-34-2 (palm oil methyl esters); 91051-32-0 (palm kernel oil methyl esters); 73891-99-3 (rapeseed oil methyl esters); 61788-61-2 (tallow methyl esters); 68990-52-3 (vegetable oil methyl esters); 129828-16-6 (canola oil methyl esters); 67762-26-9 (unsaturated alkylcarboxylic acid methyl ester); or 68937-84-8 (fatty acids, C12-C18, methyl ester).

    The B100 product subject to the investigation is currently classifiable under subheading 3826.00.1000 of the Harmonized Tariff Schedule of the United States (HTSUS), while the B99 product is currently classifiable under HTSUS subheading 3826.00.3000. Although the HTSUS subheadings, ASTM specifications, and CAS numbers are provided for convenience and customs purposes, the written description of the scope is dispositive.

    Appendix II List of Topics Discussed in the Preliminary Decision Memorandum I. Summary II. Background III. Period of Investigation IV. Use of Facts Available and Adverse Facts Available A. Legal Authority B. Application of Facts Available to Musim Mas C. Use of Adverse Inferences D. Selection and Corroboration of AFA Rate V. Affiliation and Collapsing A. Wilmar VI. Discussion of the Methodology A. Comparisions to Fair Value VII. Product Comparisons VIII. Date of Sale IX. Export Price and Constructed Price X. Normal Value A. Home Market Viability XI. Particular Market Situation A. Background B. Interested Parties' Arguments C. Analysis XII. Calculation of Normal Value Based on Constructed Value XIII. Circumstance of Sale XIV. Adjustment to Cash Deposit Rate for Export Subsidies XV. Currency Conversion XVI. Conclusion
    [FR Doc. 2017-23602 Filed 10-30-17; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-475-836] Carbon and Alloy Steel Wire Rod From Italy: Preliminary Affirmative Determination of Sales at Less Than Fair Value AGENCY:

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

    SUMMARY:

    The Department of Commerce (the Department) preliminarily determines that carbon and alloy steel wire rod (wire rod) from Italy is being, or is likely to be, sold in the United States at less than fair value (LTFV). The period of investigation (POI) is January 1, 2016, through December 31, 2016.

    DATES:

    Applicable October 31, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Victoria Cho or Mark Flessner, 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) 482-5075 or (202) 482-6312, respectively.

    SUPPLEMENTARY INFORMATION: Background

    This preliminary determination is made in accordance with section 733(b) of the Tariff Act of 1930, as amended (the Act). The Department published the notice of initiation of this investigation on April 20, 2017.1 On August 21, 2017, the Department postponed the preliminary determination of this investigation, and the revised deadline is now October 24, 2017.2 For a complete description of the events that followed the initiation of this investigation, see the Preliminary Decision Memorandum.3 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, 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 and the electronic versions of the Preliminary Decision Memorandum are identical in content.

    1See Carbon and Alloy Steel Wire Rod from Belarus, Italy, the Republic of Korea, the Russian Federation, South Africa, Spain, the Republic of Turkey, Ukraine, United Arab Emirates, and United Kingdom: Initiation of Less-Than-Fair-Value Investigations, 82 FR 19207 (April 20, 2017) (Initiation Notice).

    2See Carbon and Alloy Steel Wire Rod from Italy, the Republic of Korea, the Republic of South Africa, Spain, the Republic of Turkey, Ukraine and the United Kingdom: Postponement of Preliminary Determinations in the Less-Than-Fair-Value Investigations, 82 FR 39564 (August 21, 2017).

    3See Memorandum, “Decision Memorandum for the Preliminary Determination in the Less-Than-Fair-Value Investigation of Carbon and Alloy Wire from Italy” dated concurrently with, and hereby adopted by, this notice (Preliminary Decision Memorandum).

    Scope of the Investigation

    The products covered by this investigation are wire rod from the Italy. For a complete description of the scope of this investigation, see Appendix I.

    Scope Comments

    In accordance with the preamble to the Department's regulations,4 the Initiation Notice set aside a period of time for parties to raise issues regarding product coverage (scope).5 Certain interested parties commented on the scope of the investigation as it appeared in the Initiation Notice. For a summary of the product coverage comments and rebuttal responses submitted to the record for this investigation, and accompanying discussion and analysis of all comments timely received, see the Preliminary Scope Decision Memorandum.6 Since the issuance of the Preliminary Scope Decision Memorandum, certain parties submitted scope case briefs or scope rebuttal briefs.7 The Department will issue a final scope decision on the records of the wire rod investigations after considering those comments submitted in scope case and rebuttal briefs.

    4See Antidumping Duties; Countervailing Duties, Final Rule, 62 FR 27296, 27323 (May 19, 1997).

    5See Initiation Notice at 19207-08.

    6See Memorandum, “Carbon and Alloy Steel Wire Rod from Belarus, Italy, the Republic of Korea, the Russian Federation, South Africa, Spain, the Republic of Turkey, Ukraine, the United Arab Emirates, and the United Kingdom: Scope Comments Decision Memorandum for the Preliminary Determinations,” dated August 7, 2017 (Preliminary Scope Decision Memorandum).

    7See Preliminary Decision Memorandum.

    Affiliation and Collapsing

    In accordance with section 771(33)(F) of the Act, 19 CFR 351.401(f), and the Department's practice,8 we are treating Ferriere Nord S.p.A. (Ferriere Nord) and Acciaierie di Verona S.p.A. (AdV) as a single entity for the purposes of this preliminary determination.9

    8See, e.g., Notice of Final Determination of Sales at Less Than Fair Value: Coated Free Sheet Paper from Indonesia, 72 FR 60636 (October 25, 2007), and accompanying Issues and Decision Memorandum; Certain Coated Paper Suitable for High-Quality Print Graphics Using Sheet-Fed Presses from Indonesia: Final Determination of Sales at Less Than Fair Value, 75 FR 59223 (September 27, 2010), and accompanying Issues and Decision Memorandum.

    9 For further discussion of this issue, see Memorandum entitled, “Certain Carbon and Alloy Steel Wire Rod from Italy: Ferriere Nord S.p.A. and Acciaierie di Verona S.p.A. Affiliation and Collapsing Memorandum” (Ferriere Nord and AdV Prelim Affiliation and Collapsing Memo), dated concurrently with this preliminary determination.

    Methodology

    The Department is conducting this investigation in accordance with section 731 of the Act. The Department has calculated export prices in accordance with section 772(a) of the Act. Normal value (NV) is calculated in accordance with section 773 of the Act. Furthermore, pursuant to section 776(a) and (b) of the Act, the Department has preliminarily relied upon facts otherwise available with adverse inferences to assign a margin for Ferriera Valsider S.p.A. (Ferriera Valsider). For a full description of the methodology underlying the preliminary determination, see the Preliminary Decision Memorandum.

    All-Others Rate

    Sections 733(d)(1)(A)(ii) and 735(c)(5)(A) of the Act provide that in the preliminary determination the Department shall determine an estimated all-others rate for all exporters and producers not individually examined. This rate shall be an amount equal to the weighted average of the estimated weighted-average dumping margins established for exporters and producers individually investigated, excluding any zero and de minimis margins, and any margins determined entirely under section 776 of the Act.

    In this investigation, the Department preliminarily calculated a rate that is not zero, de minimis or based entirely on facts otherwise available for Ferriere Nord. Because this is the only such rate, the rate calculated for Ferriere Nord is also assigned as the rate for all-other producers and exporters. Additionally, for the reasons discussed in the Preliminary Decision Memorandum, we are applying this rate to Ferriera Valsider as facts available with an adverse inference.

    Preliminary Determination

    The Department preliminarily determines that the following estimated weighted-average dumping margins exist:

    Exporter/producer Estimated
  • weighted-
  • average
  • dumping
  • margin
  • (percent)
  • Ferriere Nord S.p.A./Acciaierie di Verona S.p.A 22.06 Ferriera Valsider S.p.A 22.06 All-Others 22.06
    Suspension of Liquidation

    In accordance with section 733(d)(2) of the Act, the Department will direct U.S. Customs and Border Protection (CBP) to suspend liquidation of entries of subject merchandise, as described in Appendix I, entered, or withdrawn from warehouse, for consumption on or after the date of publication of this notice in the Federal Register. Further, pursuant to section 733(d)(1)(B) of the Act and 19 CFR 351.205(d), the Department will instruct CBP to require a cash deposit equal to the estimated weighted-average dumping margin or the estimated all-others rate, as follows: (1) The cash deposit rate for the respondents listed above will be equal to the company-specific estimated weighted-average dumping margins determined in this preliminary determination; (2) if the exporter is not a respondent identified above, but the producer is, then the cash deposit rate will be equal to the company-specific estimated weighted-average dumping margin established for that producer of the subject merchandise; and (3) the cash deposit rate for all other producers and exporters will be equal to the all-others estimated weighted-average dumping margin.

    Disclosure

    The Department intends to disclose its calculations and analysis performed to interested parties in this preliminary determination within five days of any public announcement or, if there is no public announcement, within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b).

    Verification

    As provided in section 782(i)(1) of the Act, the Department intends to verify the information relied upon in making its final determination.

    Public Comment

    Case briefs or other written comments may be submitted to the Assistant Secretary for Enforcement and Compliance no later than seven days after the date on which the last verification report is issued in this investigation. Rebuttal briefs, limited to issues raised in case briefs, may be submitted no later than five days after the deadline date for case briefs.10 Pursuant to 19 CFR 351.309(c)(2) and (d)(2), parties who submit case briefs or rebuttal briefs in this investigation 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.

    10See 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.

    Final Determination

    Section 735(a)(1) of the Act and 19 CFR 351.210(b)(1) provide that the Department will issue the final determination within 75 days after the date of its preliminary determination. Accordingly, the Department will make its final determination no later than 75 days after the signature date of this preliminary determination.

    International Trade Commission Notification

    In accordance with section 733(f) of the Act, the Department will notify the International Trade Commission (ITC) of its preliminary determination. If the final determination is affirmative, the ITC will determine before the later of 120 days after the date of this preliminary determination or 45 days after the final determination whether these imports are materially injuring, or threaten material injury to, the U.S. industry.

    Notification to Interested Parties

    This determination is issued and published in accordance with sections 733(f) and 777(i)(1) of the Act and 19 CFR 351.205(c).

    Dated: October 24, 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 Investigation

    The products covered by this investigation are certain hot-rolled products of carbon steel and alloy steel, in coils, of approximately round cross section, less than 19.00 mm in actual solid cross-sectional diameter. Specifically excluded are steel products possessing the above-noted physical characteristics and meeting the Harmonized Tariff Schedule of the United States (HTSUS) definitions for (a) stainless steel; (b) tool steel; (c) high-nickel steel; (d) ball bearing steel; or (e) concrete reinforcing bars and rods. Also excluded are free cutting steel (also known as free machining steel) products (i.e., products that contain by weight one or more of the following elements: 0.1 percent of more of lead, 0.05 percent or more of bismuth, 0.08 percent or more of sulfur, more than 0.04 percent of phosphorous, more than 0.05 percent of selenium, or more than 0.01 percent of tellurium). All products meeting the physical description of subject merchandise that are not specifically excluded are included in this scope.

    The products under investigation are currently classifiable under subheadings 7213.91.3011, 7213.91.3015, 7213.91.3020, 7213.91.3093, 7213.91.4500, 7213.91.6000, 7213.99.0030, 7227.20.0030, 7227.20.0080, 7227.90.6010, 7227.90.6020, 7227.90.6030, and 7227.90.6035 of the HTSUS. Products entered under subheadings 7213.99.0090 and 7227.90.6090 of the HTSUS may also be included in this scope if they meet the physical description of subject merchandise above. Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of the scope of these proceedings is dispositive.

    Appendix II List of Topics Discussed in the Preliminary Decision Memorandum I. Summary II. Background III. Period of Investigation IV. Scope Comments V. Affiliation and Collapsing VI. Discussion of the Methodology A. Determination of the Comparison Method B. Results of the Differential Pricing Analysis VII. Date of Sale VIII. Product Comparisons IX. Export Price and Constructed Export Price X. Normal Value A. Home Market Viability B. Level of Trade C. Cost of Production (COP) Analysis 1. Calculation of COP 2. Test of Comparison Market Sales Prices 3. Results of the COP Test D. Calculation of NV Based on Comparison Market Prices XI. Application of Facts Available and Use of Adverse Inference XII. Currency Conversion XIII. Conclusion
    [FR Doc. 2017-23645 Filed 10-30-17; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-791-823] Carbon and Alloy Steel Wire Rod From the Republic of South Africa: Preliminary Affirmative Determination of Sales at Less Than Fair Value, Preliminary Affirmative Determination of Critical Circumstances, and Preliminary Determination of No Shipments AGENCY:

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

    SUMMARY:

    The Department of Commerce (the Department) preliminarily determines that carbon and alloy steel wire rod (wire rod) from the Republic of South Africa (South Africa) is being, or is likely to be, sold in the United States at less than fair value (LTFV). The period of investigation (POI) is January 1, 2016, through December 31, 2016.

    DATES:

    Applicable October 31, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Moses Song or John McGowan, AD/CVD Operations, Office VI, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-5041 or (202) 482-3019, respectively.

    SUPPLEMENTARY INFORMATION:

    Background

    This preliminary determination is made in accordance with section 733(b) of the Tariff Act of 1930, as amended (the Act). The Department published the notice of initiation of this investigation on April 26, 2017.1 On August 21, 2017, the Department postponed the preliminary determination of this investigation and the revised deadline is now October 24, 2017.2 For a complete description of the events that followed the initiation of this investigation, see the Preliminary Decision Memorandum.3 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, 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 and the electronic versions of the Preliminary Decision Memorandum are identical in content.

    1See Carbon and Alloy Steel Wire Rod from Belarus, Italy, the Republic of Korea, the Russian Federation, South Africa, Spain, the Republic of Turkey, Ukraine, United Arab Emirates, and United Kingdom: Initiation of Less-Than-Fair-Value Investigations, 82 FR 19207 (April 26, 2017) (Initiation Notice).

    2See Carbon and Alloy Steel Wire Rod from Italy, the Republic of Korea, the Republic of South Africa, Spain, the Republic of Turkey, Ukraine and the United Kingdom: Postponement of Preliminary Determinations in the Less-Than-Fair-Value Investigations, 82 FR 39564 (August 21, 2017).

    3See Memorandum, “Decision Memorandum for the Preliminary Determination in the Less-Than-Fair-Value Investigation of Carbon and Alloy Steel Wire Rod from the Republic of South Africa” dated concurrently with, and hereby adopted by, this notice (Preliminary Decision Memorandum).

    Scope of the Investigation

    The products covered by this investigation are wire rod from South Africa. For a complete description of the scope of this investigation, see Appendix I.

    Scope Comments

    In accordance with the preamble to the Department's regulations,4 the Initiation Notice set aside a period of time for parties to raise issues regarding product coverage (scope).5 Certain interested parties commented on the scope of the investigation as it appeared in the Initiation Notice. For a summary of the product coverage comments and rebuttal responses submitted to the record for this investigation, and accompanying discussion and analysis of all comments timely received, see the Preliminary Scope Decision Memorandum.6 Since the issuance of the Preliminary Scope Decision Memorandum, certain parties submitted scope case briefs or scope rebuttal briefs.7 The Department will issue a final scope decision on the records of the wire rod investigations after considering those comments submitted in scope case and rebuttal briefs.

    4See Antidumping Duties; Countervailing Duties, Final Rule, 62 FR 27296, 27323 (May 19, 1997).

    5See Initiation Notice, 82 FR at 19207-08.

    6See Memorandum, “Carbon and Alloy Steel Wire Rod from Belarus, Italy, the Republic of Korea, the Russian Federation, South Africa, Spain, the Republic of Turkey, Ukraine, the United Arab Emirates, and the United Kingdom: Scope Comments Decision Memorandum for the Preliminary Determinations,” dated August 7, 2017 (Preliminary Scope Decision Memorandum).

    7See Preliminary Decision Memorandum.

    Methodology

    The Department is conducting this investigation in accordance with section 731 of the Act. Based on the record evidence and the Department's practice, we preliminarily find that mandatory respondent ArcelorMittal South Africa Limited (AMSA), mandatory respondent Scaw South Africa (Pty) Ltd. (also known as Scaw Metals Group) (Scaw), and Consolidated Wire Industries (CWI) are affiliated and should be collapsed into one entity (i.e., AMSA/Scaw/CWI).8 Further, a part of the entity, Scaw, failed to respond to the Department's antidumping duty questionnaire. Thus, the Department is relying on the facts otherwise available with adverse inference for the collapsed entity.9 For further information, see the Preliminary Decision Memorandum.

    8Id.

    9See section 776(a) and (b) of the Act.

    Preliminary Determination of No Sales

    On April 26, 2017, Davsteel Division of Cape Gate (Pty) Ltd. (Cape Gate), one of the three South African producers/exporters named in the petition,10 timely filed a statement reporting that it had “no exports, shipments, or sales” of subject merchandise to the United States during the POI.11 Subsequently, we received information from U.S. Customs and Border Protection (CBP) confirming Cape Gate's claim that it had no entries of subject merchandise during the POI.12 Furthermore, there is no evidence on the record indicating that Cape Gate is affiliated with AMSA, Scaw or CWI. Based on the foregoing, the Department preliminarily determines that Cape Gate had no sales of subject merchandise during the POI, and, therefore, we preliminarily determine not to further examine Cape Gate as part of this investigation. As such, any entries of subject merchandise exported by Cape Gate will be subject to the All-Others Rate. For additional information regarding this determination, see the Preliminary Decision Memorandum.

    10See the Petitions for the Imposition of Antidumping Duties on Imports of Carbon and Alloy Steel Wire Rod from Belarus, Italy, the Republic of Korea, the Russian Federation, the Republic of South Africa, Spain, Turkey, Ukraine, United Arab Emirates, and the United Kingdom; and Countervailing Duties on Imports from Turkey and Italy, dated March 28, 2017 (the Petition), Volume VI at 1, and Volume I at Exhibit I-7.

    11See Letter from the Department to the respondent, regarding “Certain Carbon and Alloy Steel Wire Rod from the Republic of South Africa: No Shipment Certification,” dated April 26, 2017 (Cape Gate's No-shipment Claim).

    12See Memorandum to The File, entitled “No Shipment Inquiry Regarding Davsteel Division of Cape Gate (PTY) Ltd. And/or Cape Gate (Pty) Ltd. During the Period 01/01/2016—12/31/2016,” dated June 5, 2017 (CBP No-shipment Claim Confirmation Memorandum).

    Preliminary Affirmative Determination of Critical Circumstances

    In accordance with section 733(e) of the Act and 19 CFR 351.206, the Department preliminarily finds that critical circumstances exist for the collapsed entity AMSA/Scaw/CWI and all other producers and exporters. For a description of the methodology and results of the Department's critical circumstances analysis, see the Preliminary Decision Memorandum.

    All-Others Rate

    Pursuant to section 735(c)(5)(B) of the Act, if the estimated weighted-average dumping margins established for all exporters and producers individually examined are zero, de minimis or determined based entirely on facts otherwise available, the Department may use any reasonable method to establish the estimated weighted-average dumping margin for all-other producers or exporters. The Department has preliminarily determined the estimated weighted-average dumping margin for AMSA/Scaw/CWI, the collapsed entity, pursuant to section 776 of the Act. According to section 735(c)(5)(A), the Department typically averages the individually examined respondents' rates to calculate the all-others rate. Because the Department is preliminarily applying the AFA rate to the collapsed entity, however, the Department preliminarily determines to calculate the “all-others” rate as a simple average of the alleged dumping margin(s) from the petition, pursuant to section 735(c)(5)(B).13 The rates in the petition, as amended, were 128.66 percent and 142.26 percent, so the All-Others rate is 135.46 percent.14

    13See, e.g., Notice of Preliminary Determination of Sales at Less Than Fair Value: Sodium Nitrite from the Federal Republic of Germany, 73 FR 21909, 21912 (April 23, 2008), unchanged in Notice of Final Determination of Sales at Less Than Fair Value: Sodium Nitrite from the Federal Republic of Germany, 73 FR 38986, 38987 (July 8, 2008), and accompanying Issues and Decision Memorandum at Comment 2; see also Notice of Final Determination of Sales at Less Than Fair Value: Raw Flexible Magnets from Taiwan, 73 FR 39673, 39674 (July 10, 2008); Steel Threaded Rod from Thailand: Preliminary Determination of Sales at Less Than Fair Value and Affirmative Preliminary Determination of Critical Circumstances, 78 FR 79670, 79671 (December 31, 2013), unchanged in Steel Threaded Rod from Thailand: Final Determination of Sales at Less Than Fair Value and Affirmative Final Determination of Critical Circumstances, 79 FR 14476, 14477 (March 14, 2014).

    14See Initiation Notice, 82 FR at 19211; see also Preliminary Decision Memorandum.

    Preliminary Determination

    The Department preliminarily determines that the following estimated weighted-average dumping margins exist:

    Exporter/producer Estimated
  • weighted-average
  • dumping margin
  • (percent)
  • ArcelorMittal South Africa Limited, Scaw South Africa (Pty) Ltd. (also known as Scaw Metals Group), and Consolidated Wire Industries 142.26 All-Others 135.46
    Suspension of Liquidation

    In accordance with section 733(d)(2) of the Act, the Department will direct U.S. Customs and Border Protection (CBP) to suspend liquidation of entries of subject merchandise, as described in Appendix I, entered, or withdrawn from warehouse, for consumption on or after the date of publication of this notice in the Federal Register. Further, pursuant to section 733(d)(1)(B) of the Act and 19 CFR 351.205(d), the Department will instruct CBP to require a cash deposit equal to the estimated weighted-average dumping margin or the estimated all-others rate, as follows: (1) The cash deposit rate for the respondents listed above will be equal to the company-specific estimated weighted-average dumping margins determined in this preliminary determination; (2) if the exporter is not a respondent identified above, but the producer is, then the cash deposit rate will be equal to the company-specific estimated weighted-average dumping margin established for that producer of the subject merchandise; and (3) the cash deposit rate for all other producers and exporters will be equal to the all-others estimated weighted-average dumping margin.

    Section 733(e)(2) of the Act provides that, given an affirmative determination of critical circumstances, any suspension of liquidation shall apply to unliquidated entries of subject merchandise entered, or withdrawn from warehouse, for consumption on or after the later of (a) the date which is 90 days before the date on which the suspension of liquidation was first ordered, or (b) the date on which notice of initiation of the investigation was published. The Department preliminarily finds that critical circumstances exist for imports of subject merchandise produced or exported by AMSA/Scaw/CWI and all other exporters/producers. In accordance with section 733(e)(2)(A) of the Act, the suspension of liquidation shall apply to unliquidated entries of shipments of subject merchandise from the producer or exporter identified in this paragraph that were entered, or withdrawn from warehouse, for consumption on or after the date which is 90 days before the publication of this notice. These suspension of liquidation instructions will remain in effect until further notice.

    Disclosure

    Normally, the Department discloses to interested parties the calculations performed in connection with a preliminary determination within five days of any public announcement or, if there is no public announcement, within five days of the date of publication of the notice of preliminary determination in the Federal Register, in accordance with 19 CFR 351.224(b). However, because the Department preliminarily applied AFA to the collapsed entity (i.e., AMSA/Scaw/CWI) in this investigation, in accordance with section 776 of the Act, and the applied AFA rate is based solely on the petition, there are no calculations to disclose.

    Verification

    Because the examined respondent (i.e., the collapsed entity referenced above) in this investigation did not provide information requested by the Department, and the Department preliminarily determines it to have been uncooperative, we will not conduct verification.

    Public Comment

    Case briefs or other written comments may be submitted to the Assistant Secretary for Enforcement and Compliance no later than 50 days after the date of publication of the preliminary determination, 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.15 Pursuant to 19 CFR 351.309(c)(2) and (d)(2), parties who submit case briefs or rebuttal briefs in this investigation 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.

    15See 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.

    Final Determination

    Section 735(a)(1) of the Act and 19 CFR 351.210(b)(1) provide that the Department will issue the final determination within 75 days after the date of its preliminary determination. Accordingly, the Department will make its final determination no later than 75 days after the signature date of this preliminary determination.

    International Trade Commission Notification

    In accordance with section 733(f) of the Act, the Department will notify the International Trade Commission (ITC) of its preliminary determination. If the final determination is affirmative, the ITC will determine before the later of 120 days after the date of this preliminary determination or 45 days after the final determination whether these imports are materially injuring, or threaten material injury to, the U.S. industry.

    Notification to Interested Parties

    This determination is issued and published in accordance with sections 733(f) and 777(i)(1) of the Act and 19 CFR 351.205(c).

    Dated: October 24, 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 Investigation

    The products covered by this investigation are certain hot-rolled products of carbon steel and alloy steel, in coils, of approximately round cross section, less than 19.00 mm in actual solid cross-sectional diameter. Specifically excluded are steel products possessing the above-noted physical characteristics and meeting the Harmonized Tariff Schedule of the United States (HTSUS) definitions for (a) stainless steel; (b) tool steel; (c) high-nickel steel; (d) ball bearing steel; or (e) concrete reinforcing bars and rods. Also excluded are free cutting steel (also known as free machining steel) products (i.e., products that contain by weight one or more of the following elements: 0.1 percent of more of lead, 0.05 percent or more of bismuth, 0.08 percent or more of sulfur, more than 0.04 percent of phosphorous, more than 0.05 percent of selenium, or more than 0.01 percent of tellurium). All products meeting the physical description of subject merchandise that are not specifically excluded are included in this scope.

    The products under investigation are currently classifiable under subheadings 7213.91.3011, 7213.91.3015, 7213.91.3020, 7213.91.3093, 7213.91.4500, 7213.91.6000, 7213.99.0030, 7227.20.0030, 7227.20.0080, 7227.90.6010, 7227.90.6020, 7227.90.6030, and 7227.90.6035 of the HTSUS. Products entered under subheadings 7213.99.0090 and 7227.90.6090 of the HTSUS may also be included in this scope if they meet the physical description of subject merchandise above. Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of the scope of these proceedings is dispositive.

    Appendix II List of Topics Discussed in the Preliminary Decision Memorandum I. Summary II. Background III. Period of Investigation IV. Scope Comments V. Preliminary Determination of No Shipments VI. Affiliation and Collapsing of Affiliates VII. Application of Facts Available and Use of Adverse Inference A. Application of Facts Available B. Use of Adverse Inference C. Selection and Corroboration of the AFA Rate VIII. All-Others Rate IX. Critical Circumstances A. Legal Framework B. Critical Circumstances Allegation C. Analysis X. Conclusion
    [FR Doc. 2017-23649 Filed 10-30-17; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-580-891] Carbon and Alloy Steel Wire Rod From the Republic of Korea: Preliminary Affirmative Determination of Sales at Less Than Fair Value, and Preliminary Negative Determination of Critical Circumstances AGENCY:

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

    SUMMARY:

    The Department of Commerce (the Department) preliminarily determines that Carbon and Alloy Steel Wire Rod (wire rod) from the Republic of Korea (Korea) is being, or is likely to be, sold in the United States at less than fair value (LTFV). The period of investigation (POI) is January 1, 2016, through December 31, 2016.

    DATES:

    Applicable October 31, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Lingjun Wang or Toni Page, 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) 482-2316 or (202) 482-1398.

    SUPPLEMENTARY INFORMATION: Background

    This preliminary determination is made in accordance with section 733(b) of the Tariff Act of 1930, as amended (the Act). The Department published the notice of initiation of this investigation on April 26, 2017.1 On August 21, 2017, the Department postponed the preliminary determination of this investigation and revised the deadline to October 24, 2017.2 For a complete description of the events that followed the initiation of this investigation, see the Preliminary Decision Memorandum.3 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, 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 and the electronic versions of the Preliminary Decision Memorandum are identical in content.

    1See Carbon And Alloy Steel Wire Rod From Belarus, Italy, the Republic of Korea, the Russian Federation, South Africa, Spain, the Republic of Turkey, Ukraine, United Arab Emirates, and United Kingdom: Initiation of Less-Than-Fair-Value Investigations, 82 FR 19207 (April 26, 2017) (Initiation Notice).

    2See Carbon And Alloy Steel Wire Rod From Belarus, Italy, the Republic of Korea, the Russian Federation, South Africa, Spain, the Republic of Turkey, Ukraine, United Arab Emirates, and United Kingdom: Initiation of Less-Than-Fair-Value Investigations: Postponement of Preliminary Determinations of Antidumping Duty Investigations, 82 FR 35964 (August 21, 2017).

    3See Memorandum, “Decision Memorandum for the Preliminary Affirmative Determination of Saels at Less-Than-Fair-Value, Preliminary Negative Determination of Critical Circumstances, in the investigation of Carbon And Alloy Steel Wire Rod From the Republic of Korea” dated concurrently with, and hereby adopted by, this notice (Preliminary Decision Memorandum).

    Scope of the Investigation

    The products covered by this investigation are wire rod from Korea. For a complete description of the scope of this investigation, see Appendix I.

    Scope Comments

    In accordance with the preamble to the Department's regulations,4 the Initiation Notice set aside a period of time for parties to raise issues regarding product coverage (i.e., scope).5 Certain interested parties commented on the scope of the investigation as it appeared in the Initiation Notice. For a summary of the product coverage comments and rebuttal responses submitted on the record for this preliminary determination, and accompanying discussion and analysis of all comments timely received, see the Preliminary Scope Decision Memorandum.6 The Department is not preliminarily modifying the scope language as it appeared in the Initiation Notice. See the scope in Appendix I to this notice.

    4See Antidumping Duties; Countervailing Duties, Final Rule, 62 FR 27296, 27323 (May 19, 1997).

    5See Initiation Notice.

    6See Memorandum, “Carbon And Alloy Steel Wire Rod From Belarus, Italy, the Republic of Korea, the Russian Federation, South Africa, Spain, the Republic of Turkey, Ukraine, United Arab Emirates, and United Kingdom: Scope Comments Decision Memorandum for the Preliminary Determination” (Preliminary Scope Decision Memorandum), dated concurrently with this preliminary determination.

    Methodology

    The Department is conducting this investigation in accordance with section 731 of the Act. The Department has calculated export prices in accordance with section 772(a) of the Act. Constructed export prices have been calculated in accordance with section 772(b) of the Act. Normal value (NV) is calculated in accordance with section 773 of the Act. For a full description of the methodology underlying the preliminary determination, see the Preliminary Decision Memorandum.

    Preliminary Negative Determination of Critical Circumstances

    In accordance with section 733(e) of the Act and 19 CFR 351.206, the Department preliminarily finds that critical circumstances do not exist for POSCO or All-Other producers and exporters. For a full description of the methodology and results of the Department's critical circumstances analysis, see the Preliminary Decision Memorandum.

    All-Others Rate

    Sections 733(d)(1)(ii) and 735(c)(5)(A) of the Act provide that in the preliminary determination the Department shall determine an estimated all-others rate for all exporters and producers not individually examined. This rate shall be 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 under section 776 of the Act.

    The Department calculated an individual estimated weighted-average dumping margin for POSCO, the only individually exporter/producer to receive an individually calculated rate. Because the only individually calculated dumping margin is not zero, de minimis, or based entirely on facts otherwise available, the estimated weighted-average dumping margin calculated for POSCO is the margin assigned to all-other producers and exporters, pursuant to section 735(c)(5)(A) of the Act.

    Preliminary Determination

    The Department preliminarily determines that the following estimated weighted-average dumping margins exist:

    Exporter/producer Estimated
  • weighted-
  • average
  • dumping
  • margin
  • (percent)
  • POSCO 10.09 All-Others 10.09
    Suspension of Liquidation

    In accordance with section 733(d)(2) of the Act, the Department will direct U.S. Customs and Border Protection (CBP) to suspend liquidation of entries of subject merchandise, as described in Appendix I, entered, or withdrawn from warehouse, for consumption on or after the date of publication of this notice in the Federal Register. Further, pursuant to section 733(d)(1)(B) of the Act and 19 CFR 351.205(d), the Department will instruct CBP to require a cash deposit equal to the estimated weighted-average dumping margin or the estimated all-others rate, as follows: (1) The cash deposit rate for the respondent listed above will be equal to the company-specific estimated weighted-average dumping margins determined in this preliminary determination; (2) if the exporter is not a respondent identified above, but the producer is, then the cash deposit rate will be equal to the company-specific estimated weighted-average dumping margin established for that producer of the subject merchandise; and (3) the cash deposit rate for all other producers and exporters will be equal to the all-others estimated weighted-average dumping margin.

    Disclosure

    The Department intends to disclose its calculations and analysis performed to interested parties in this preliminary determination within five days of any public announcement or, if there is no public announcement, within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b).

    Verification

    As provided in section 782(i)(1) of the Act, the Department intends to verify the information relied upon in making its final determination.

    Public Comment

    Case briefs or other written comments may be submitted to the Assistant Secretary for Enforcement and Compliance no later than seven days after the date on which the last verification report is issued in this investigation. Rebuttal briefs, limited to issues raised in case briefs, may be submitted no later than five days after the deadline date for case briefs.7 Pursuant to 19 CFR 351.309(c)(2) and (d)(2), parties who submit case briefs or rebuttal briefs in this investigation 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.

    7See 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.

    Final Determination

    Section 735(a)(1) of the Act and 19 CFR 351.210(b)(1) provide that the Department will issue the final determination within 75 days after the date of its preliminary determination. Accordingly, the Department will make its final determination no later than 75 days after the signature date of this preliminary determination.

    International Trade Commission Notification

    In accordance with section 733(f) of the Act, the Department will notify the International Trade Commission (ITC) of its preliminary determination. If the final determination is affirmative, the ITC will determine before the later of 120 days after the date of this preliminary determination or 45 days after the final determination whether these imports are materially injuring, or threaten material injury to, the U.S. industry.

    Notification to Interested Parties

    This determination is issued and published in accordance with sections 733(f) and 777(i)(1) of the Act and 19 CFR 351.205(c).

    Dated: October 24, 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 Investigation

    The products covered by this investigation are certain hot-rolled products of carbon steel and alloy steel, in coils, of approximately round cross section, less than 19.00 mm in actual solid cross-sectional diameter. Specifically excluded are steel products possessing the above-noted physical characteristics and meeting the Harmonized Tariff Schedule of the United States (HTSUS) definitions for (a) stainless steel; (b) tool steel; (c) high-nickel steel; (d) ball bearing steel; or (e) concrete reinforcing bars and rods. Also excluded are free cutting steel (also known as free machining steel) products (i.e., products that contain by weight one or more of the following elements: 0.1 percent or more of lead, 0.05 percent or more of bismuth, 0.08 percent or more of sulfur, more than 0.04 percent of phosphorous, more than 0.05 percent of selenium, or more than 0.01 percent of tellurium). All products meeting the physical description of subject merchandise that are not specifically excluded are included in this scope.

    The products under investigation are currently classifiable under subheadings 7213.91.3011, 7213.91.3015, 7213.91.3020, 7213.91.3093; 7213.91.4500, 7213.91.6000, 7213.99.0030, 7227.20.0030, 7227.20.0080, 7227.90.6010, 7227.90.6020, 7227.90.6030, and 7227.90.6035 of the HTSUS. Products entered under subheadings 7213.99.0090 and 7227.90.6090 of the HTSUS also may be included in this scope if they meet the physical description of subject merchandise above. Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of the scope of this proceeding is dispositive.

    Appendix II List of Topics Discussed in the Preliminary Decision Memorandum I. Summary II. Background III. Period of Investigation IV. Postponement of Final Determination and Extension of Provisional Measures V. Scope Comments VI. All-Others Rate VII. Preliminary Negative Determination of Critical Circumstances VIII. Preliminary Determination of No Sales (Not an Approporiate Party To Be Examied) IX. Affiliation and Collapsing X. Discussion of the Methodology A. Determination of the Comparison Method B. Results of the Differential Pricing Analysis XI. Date of Sale XII. Product Comparisons XIII. Export Price and Constructed Export Price XIV. Normal Value A. Home Market Viability B. Affiliated Party Transactions and Arm's-Length Test C. Level of Trade D. Cost of Production (COP) Analysis 1. Calculation of COP 2. Test of Home Market Sales Prices 3. Results of the COP Test E. Calculation of NV Based on Home Market Prices XV. Currency Conversion XVI. Conclusion Table of Authorities
    [FR Doc. 2017-23646 Filed 10-30-17; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-523-810] Polyethylene Terephthalate Resin From the Sultanate of Oman: Rescission of Antidumping Duty Administrative Review; 2015-2017 AGENCY:

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

    SUMMARY:

    The Department of Commerce (the Department) is rescinding the administrative review of the antidumping duty (AD) order on polyethylene terephthalate resin (PET resin) from the Sultanate of Oman (Oman) for the period of review (POR), i.e., October 15, 2015, through April 30, 2017.

    DATES:

    Applicable October 31, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Jonathan Hill, AD/CVD Operations, Office IV, Enforcement & Compliance, International Trade Administration, Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-3518.

    SUPPLEMENTARY INFORMATION: Background

    On July 6, 2017, based on a timely request for review by OCTAL SAOC FZC (OCTAL), the Department published in the Federal Register a notice of initiation of an administrative review of the AD order on PET resin from Oman with respect to OCTAL for the POR.1 On August 22, 2017, pursuant to 19 CFR 351.213(d)(1), OCTAL timely withdrew its request to be reviewed.2

    1See Initiation of Antidumping and Countervailing Duty Administrative Reviews, 82 FR 31292 (July 6, 2017) (Initiation Notice).

    2See Letter from OCTAL to the Secretary of Commerce “OCTAL's Withdrawal of Request for AD Review Certain Polyethylene Terephthalate (PET) Resin from the Sultanate of Oman,” dated August 22, 2017.

    Rescission of Review

    Pursuant to 19 CFR 351.213(d)(1), the Department will rescind an administrative review, in whole or in part, if the parties that requested the review withdraw their requests within 90 days of the publication of the notice of initiation of the requested review. OCTAL withdrew its review request by the 90-day deadline, and no other party requested an administrative review of the AD order. Therefore, we are rescinding the administrative review of the AD order on PET resin from Oman covering the period October 15, 2015, through April 30, 2017 in its entirety.

    Assessment

    The Department will instruct U.S. Customs and Border Protection (CBP) to assess AD duties on all appropriate entries. Because the Department is rescinding this administrative review in its entirety, the entries to which this administrative review pertains shall be assessed AD duties that are equal to the cash deposits of estimated AD duties required at the time of entry, or withdrawal from warehouse, for consumption, in accordance with 19 CFR 351.212(c)(1)(i). The Department intends to issue appropriate assessment instructions to CBP within 15 days after the publication of this notice in the Federal Register.

    Notification to Importers

    This notice serves as the only 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 presumption that reimbursement of the AD duties occurred and the subsequent assessment of doubled AD duties.

    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, which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of the return or destruction of APO materials, or conversion to judicial protective order, is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.

    Notification to Interested Parties

    This notice is issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Tariff Act of 1930, as amended, and 19 CFR 351.213(d)(4).

    Dated: October 25, 2017. James Maeder, Senior Director perfoming the duties of Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations.
    [FR Doc. 2017-23643 Filed 10-30-17; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-469-816] Carbon and Alloy Steel Wire Rod From Spain: Preliminary Affirmative Determination of Sales at Less Than Fair Value and Preliminary Determination of Critical Circumstances, in Part AGENCY:

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

    SUMMARY:

    The Department of Commerce (the Department) preliminarily determines that carbon and alloy steel wire rod (wire rod) from Spain is being, or is likely to be, sold in the United States at less than fair value (LTFV). The period of investigation (POI) is January 1, 2016, through December 31, 2016.

    DATES:

    Applicable October 31, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Davina Friedmann or Chelsey Simonovich, 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) 482-0698 or (202) 482-1979, respectively.

    SUPPLEMENTARY INFORMATION: Background

    This preliminary determination is made in accordance with section 733(b) of the Tariff Act of 1930, as amended (the Act). The Department published the notice of initiation of this investigation on April 20, 2017.1 On August 15, 2017, the Department postponed the preliminary determination of this investigation and the revised deadline is now October 24, 2017.2 For a complete description of the events that followed the initiation of this investigation, see the Preliminary Decision Memorandum.3 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, 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 and the electronic versions of the Preliminary Decision Memorandum are identical in content.

    1See Carbon and Alloy Steel Wire Rod from Belarus, Italy, the Republic of Korea, the Russian Federation, South Africa, Spain, the Republic of Turkey, Ukraine, United Arab Emirates, and United Kingdom: Initiation of Less-Than-Fair-Value Investigations, 82 FR 19207 (April 20, 2017) (Initiation Notice).

    2See Carbon and Alloy Steel Wire Rod From Italy, the Republic of Korea, the Republic of South Africa, Spain, the Republic of Turkey, Ukraine and the United Kingdom: Postponement of Preliminary Determinations in the Less-Than-Fair-Value Investigations, 82 FR 39564 (August 21, 2017).

    3See Memorandum, “Decision Memorandum for the Preliminary Determination in the Less-Than-Fair-Value Investigation of Carbon and Alloy Wire from Spain” dated concurrently with, and hereby adopted by, this notice (Preliminary Decision Memorandum).

    Scope of the Investigation

    The products covered by this investigation are wire rod from Spain. For a complete description of the scope of this investigation, see Appendix I.

    Scope Comments

    In accordance with the preamble to the Department's regulations,4 the Initiation Notice set aside a period of time for parties to raise issues regarding product coverage (i.e., scope).5 Certain interested parties commented on the scope of the investigation as it appeared in the Initiation Notice. For a summary of the product coverage comments and rebuttal responses submitted to the record for this investigation, and accompanying discussion and analysis of all comments timely received, see the Preliminary Scope Decision Memorandum.6 Since the issuance of the Preliminary Scope Decision Memorandum, certain parties submitted scope case briefs or scope rebuttal briefs.7 The Department will issue a final scope decision on the records of the wire rod investigations after considering those comments submitted in scope case and rebuttal briefs.

    4See Antidumping Duties; Countervailing Duties, Final Rule, 62 FR 27296, 27323 (May 19, 1997).

    5See Initiation Notice.

    6See Memorandum, “Carbon and Alloy Steel Wire Rod from Belarus, Italy, the Republic of Korea, the Russian Federation, South Africa, Spain, the Republic of Turkey, Ukraine, the United Arab Emirates, and the United Kingdom: Scope Comments Decision Memorandum for the Preliminary Determination” (Preliminary Scope Decision Memorandum), dated August 7, 2017.

    7See Preliminary Decision Memorandum.

    Affiliation and Collapsing

    In accordance with section 771(33)(F) of the Act, 19 CFR 351.401(f), and the Department's practice,8 we are treating Global Steel Wire (GSW), CELSA Atlantic SA (CELSA Atlantic), Compania Espanola de Laminacion (CELSA Barcelona) (collectively, CELSA) as a single entity for the purposes of this preliminary determination.9

    8See, e.g., Notice of Final Determination of Sales at Less Than Fair Value: Coated Free Sheet Paper from Indonesia, 72 FR 60636 (October 25, 2007), and accompanying Issues and Decision Memorandum; Certain Coated Paper Suitable for High-Quality Print Graphics Using Sheet-Fed Presses from Indonesia: Final Determination of Sales at Less Than Fair Value, 75 FR 59223 (September 27, 2010), and accompanying Issues and Decision Memorandum, at 4 and Comment 6.

    9 For further discussion of this issue, see Preliminary Decision Memorandum; see also Memorandum entitled, “Certain Carbon and Alloy Steel Wire Rod from Spain: GSW, CELSA Atlantic, and CELSA Barcelona Affiliation and Collapsing Memorandum,” dated concurrently with this notice; see also, Preliminary Decision Memorandum, at 4-5.

    Methodology

    The Department is conducting this investigation in accordance with section 731 of the Act. The Department has calculated export prices in accordance with section 772(a) of the Act. Normal value (NV) is calculated in accordance with section 773 of the Act. Furthermore, pursuant to section 776(a) and (b) of the Act, the Department has preliminarily relied upon adverse facts available for ArcelorMittal Espana S.A. (AME). For a full description of the methodology underlying the preliminary determination, see the Preliminary Decision Memorandum.

    Preliminary Affirmative Determination of Critical Circumstances

    In accordance with section 733(e) of the Act and 19 CFR 351.206, the Department preliminarily finds that critical circumstances do not exist for CELSA and all-other companies, but do exist for AME. For a full description of the methodology and results of the Department's critical circumstances analysis, see the Preliminary Decision Memorandum.

    All-Others Rate

    Sections 733(d)(1)(ii) and 735(c)(5)(A) of the Act provide that in the preliminary determination the Department shall determine an estimated all-others rate for all exporters and producers not individually examined. This rate shall be an amount equal to the weighted average of the estimated weighted-average dumping margins established for exporters and producers individually investigated, excluding any zero and de minimis margins, and any margins determined entirely under section 776 of the Act. In this investigation, the Department preliminarily assigned a rate based entirely on facts available to AME. Therefore, the only rate that is not zero, de minimis, or based entirely on facts otherwise available is the rate calculated for CELSA. Consequently, the estimated weighted-average dumping margin calculated for CELSA is the margin assigned to all-other producers and exporters, pursuant to section 735(c)(5)(A) of the Act.

    Preliminary Determination

    The Department preliminarily determines that the following estimated weighted-average dumping margins exist:

    Exporter/producer Estimated
  • weighted-average
  • dumping margin
  • (percent)
  • Global Steel Wire/CELSA Atlantic SA/Compania Espanola de Laminacion 20.25 ArcelorMittal Espana S.A. 32.64 All-Others 20.25
    Suspension of Liquidation

    In accordance with section 733(d)(2) of the Act, the Department will direct U.S. Customs and Border Protection (CBP) to suspend liquidation of entries of subject merchandise, as described in Appendix I, entered, or withdrawn from warehouse, for consumption on or after the date of publication of this notice in the Federal Register. Further, pursuant to section 733(d)(1)(B) of the Act and 19 CFR 351.205(d), the Department will instruct CBP to require a cash deposit equal to the estimated weighted-average dumping margin or the estimated all-others rate, as follows: (1) The cash deposit rate for the respondents listed above will be equal to the company-specific estimated weighted-average dumping margins determined in this preliminary determination; (2) if the exporter is not a respondent identified above, but the producer is, then the cash deposit rate will be equal to the company-specific estimated weighted-average dumping margin established for that producer of the subject merchandise; and (3) the cash deposit rate for all other producers and exporters will be equal to the all-others estimated weighted-average dumping margin.

    Disclosure

    The Department intends to disclose its calculations and analysis performed to interested parties in this preliminary determination within five days of any public announcement or, if there is no public announcement, within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b).

    Verification

    As provided in section 782(i)(1) of the Act, the Department intends to verify the information relied upon in making its final determination.

    Public Comment

    Case briefs or other written comments may be submitted to the Assistant Secretary for Enforcement and Compliance no later than seven days after the date on which the last verification report is issued in this investigation. Rebuttal briefs, limited to issues raised in case briefs, may be submitted no later than five days after the deadline date for case briefs.10 Pursuant to 19 CFR 351.309(c)(2) and (d)(2), parties who submit case briefs or rebuttal briefs in this investigation 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.

    10See 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.

    Final Determination

    Section 735(a)(1) of the Act and 19 CFR 351.210(b)(1) provide that the Department will issue the final determination within 75 days after the date of its preliminary determination. Accordingly, the Department will make its final determination no later than 75 days after the signature date of this preliminary determination.

    International Trade Commission Notification

    In accordance with section 733(f) of the Act, the Department will notify the International Trade Commission (ITC) of its preliminary determination. If the final determination is affirmative, the ITC will determine before the later of 120 days after the date of this preliminary determination or 45 days after the final determination whether these imports are materially injuring, or threaten material injury to, the U.S. industry.

    Notification to Interested Parties

    This determination is issued and published in accordance with sections 733(f) and 777(i)(1) of the Act and 19 CFR 351.205(c).

    Dated: October 24, 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 Investigation

    The products covered by this investigation are certain hot-rolled products of carbon steel and alloy steel, in coils, of approximately round cross section, less than 19.00 mm in actual solid cross-sectional diameter. Specifically excluded are steel products possessing the above-noted physical characteristics and meeting the Harmonized Tariff Schedule of the United States (HTSUS) definitions for (a) stainless steel; (b) tool steel; (c) high-nickel steel; (d) ball bearing steel; or (e) concrete reinforcing bars and rods. Also excluded are free cutting steel (also known as free machining steel) products (i.e., products that contain by weight one or more of the following elements: 0.1 percent or more of lead, 0.05 percent or more of bismuth, 0.08 percent or more of sulfur, more than 0.04 percent of phosphorous, more than 0.05 percent of selenium, or more than 0.01 percent of tellurium). All products meeting the physical description of subject merchandise that are not specifically excluded are included in this scope.

    The products under investigation are currently classifiable under subheadings 7213.91.3011, 7213.91.3015, 7213.91.3020, 7213.91.3093, 7213.91.4500, 7213.91.6000, 7213.99.0030, 7227.20.0030, 7227.20.0080, 7227.90.6010, 7227.90.6020, 7227.90.6030, and 7227.90.6035 of the HTSUS. Products entered under subheadings 7213.99.0090 and 7227.90.6090 of the HTSUS also may be included in this scope if they meet the physical description of subject merchandise above. Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of the scope of this proceeding is dispositive.

    Appendix II List of Topics Discussed in the Preliminary Decision Memorandum I. Summary II. Background III. Period of Investigation IV. Scope Comments V. Discussion of the Methodology A. Determination of the Comparison Methold B. Results of the Differential Pricing Analysis VI. Date of Sale VII. Product Comparisons VIII. Export Price and Constructed Export Price Discussion of the Methodology IX. Normal Value A. Home Market Viability B. Level of Trade C. Cost of Production (COP) Analysis 1. Calculation of COP 2. Test of Comparison Market Sales Prices 3. Results of the COP Test D. Calculation of NV Based on Comparison Market Prices X. Application of Facts Available and Use of Adverse Facts Available A. Application of Facts Available B. Use of Adverse Inference C. Selection and Corroboration of the AFA Rate XI. Preliminary Determination of Critical Circumstances A. Legal Framework B. Critical Circumstances Allegation C. Analysis XII. Currency Conversion XIII. Conclusion
    [FR Doc. 2017-23650 Filed 10-30-17; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-357-820] Biodiesel From Argentina: Preliminary Affirmative Determination of Sales at Less Than Fair Value, Preliminary Affirmative Determination of Critical Circumstances, in Part AGENCY:

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

    SUMMARY:

    The Department of Commerce (the Department) preliminarily determines that biodiesel from Argentina is being, or is likely to be, sold in the United States at less than fair value. The period of investigation is January 1, 2016, through December 31, 2016.

    DATES:

    Effective October 31, 2017.

    FOR FURTHER INFORMATION CONTACT:

    David Lindgren, 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) 482-3870.

    SUPPLEMENTARY INFORMATION: Background

    This preliminary determination is made in accordance with section 733(b) of the Tariff Act of 1930, as amended (the Act). The Department published the notice of initiation of this investigation on April 19, 2017.1 For a complete description of the events that followed the initiation of this investigation, 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, Room B8024 of the Department's main 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 Biodiesel from Argentina and Indonesia: Initiation of Less-Than-Fair-Value Investigations, 82 FR 18428 (April 19, 2017) (Initiation Notice).

    2See Memorandum to Gary Tavernman, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations performing the non-exclusive functions and duties of the Assistant Secretary for Enforcement and Compliance, from James Maeder, Senior Director for Antidumping and Countervailing Duty Operations performing the duties of Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, “Decision Memorandum for the Preliminary Determination in the Less-Than-Fair-Value Investigation of Biodiesel from Argentina,” dated concurrently with, and hereby adopted by, this notice (Preliminary Decision Memorandum).

    Scope of the Investigation

    The product covered by this investigation is biodiesel from Argentina. For a complete description of the scope of this investigation, see Appendix I.

    Scope Comments

    In accordance with the preamble to the Department's regulations,3 the Initiation Notice set aside a period of time for parties to raise issues regarding product coverage (i.e., scope).4 No interested party commented on the scope of the investigation as it appeared in the Initiation Notice. Therefore, the Department is not preliminarily modifying the scope language as it appeared in the Initiation Notice. See the scope in Appendix I to this notice.

    3See Antidumping Duties; Countervailing Duties, Final Rule, 62 FR 27296, 27323 (May 19, 1997).

    4See Initiation Notice.

    Methodology

    The Department is conducting this investigation in accordance with section 731 of the Act. The Department has calculated export prices in accordance with section 772(a) of the Act. Constructed export prices have been calculated in accordance with section 772(b) of the Act. Normal value (NV) is calculated in accordance with section 773 of the Act. For a full description of the methodology underlying the preliminary determination, see the Preliminary Decision Memorandum.

    Preliminary Affirmative Determination of Critical Circumstances, in Part

    In accordance with section 733(e) of the Act and 19 CFR 351.206, the Department preliminarily finds that critical circumstances exist for LDC Argentina S.A. (LDC) and “all other” producers or exporters not individually examined. We preliminarily find that critical circumstances do not exist for Vicentin S.A.I.C. (Vicentin) and certain affiliated companies (collectively, the Vicentin Group).5 For a full description of the methodology and results of the Department's critical circumstances analysis, see the Preliminary Decision Memorandum.

    5 Vicentin Group consists of the following companies: Vicentin, Renova S.A., Oleaginosa Moreno Hermanos S.A., Molinos Agro S.A., Patagonia Energia S.A., VFG Inversiones y Actividades Especiales S.A., Vicentin S.A.I.C. Sucursal Uy, Trading Company X, and Molinos Overseas Commodities S.A. See Preliminary Decision Memorandum at “Affiliation and Collapsing.”

    Particular Market Situation

    On August 2, 2017, the National Biodiesel Board Fair Trade Coalition (petitioner) filed a particular market situation (PMS) allegation with respect to the respondents' home market sales prices and reported costs of production.6 The petitioner asserts that a PMS exists in Argentina because the Government of Argentina (GOA) sets both mandatory monthly sales prices and sales quotas for biodiesel producers, and restrains the exports of soybeans with an export tax, thereby depressing the respondents' reported raw material costs in Argentina. The petitioner argues that the Department should disregard the respondents' home market sales based on a finding that they are significantly distorted by government intervention. The petitioner also urges the Department to make an adjustment for the price of soybeans purchased from domestic suppliers to address the distorted Argentine market for soybeans.

    6See Petitioner's Letter, “Biodiesel from Argentina: Petitioner's Particular Market Situation Allegation Regarding Respondents' Home Market Sales and Costs of Production,” dated August 2, 2017 (PMS Allegation).

    The respondent Vicentin argues that the Department has a preference for using home market prices and that the standard for finding a PMS and rejecting home market prices is that the government control must be so extensive that pricing is not longer profitable.7 Vicentin contends the GOA's prices allow for a return on capital. Furthermore, Vicentin asserts that the claim that the export tax on soybeans is distortive is speculative and it cites studies finding that the elimination of the export tax would have a negligible effect on domestic soybean prices. Finally, Vicentin contends that the Department has previously made clear that a single subsidized raw material is insufficient to conclude that a PMS exists.

    7See Vicentin's Affirmative Pre-Preliminary Comments at 5.

    Based on the facts on the record, the Department preliminarily finds that the GOA's regulation of the domestic biodiesel market amounts to a PMS in Argentina that renders the home market prices of the Vicentin Group and LDC outside the ordinary course of trade. Therefore, the Department is preliminarily relying on constructed value as the basis for NV in this investigation for both respondents. The Department also preliminarily finds that a PMS exists in Argentina with regard to the price of soybeans as a component of the cost of manufacturing (COM) for biodiesel. Therefore, the Department has adjusted the Vicentin Group's and LDC's COM to account for the distorted cost of soybeans. For a full description of the methodology underlying the PMS determination, see the Preliminary Decision Memorandum.

    All-Others Rate

    Sections 733(d)(1)(ii) and 735(c)(5)(A) of the Act provide that, in the preliminary determination, the Department shall determine an estimated all-others rate for all exporters and producers not individually examined. This rate shall be an amount equal to the weighted average of the estimated weighted-average dumping margins established for exporters and producers individually investigated, excluding rates that are zero, de minimis, or determined entirely on facts available under section 776 of the Act.

    In this investigation, the Department calculated estimated weighted-average dumping margins for LDC and the Vicentin Group that are not zero, de minimis, or based entirely on facts otherwise available. The Department calculated the all-others rate using a weighted average of the estimated weighted-average dumping margins calculated for the examined respondents using each company's publicly-ranged values for the merchandise under consideration.8

    8 With two respondents under examination, the Department normally calculates (A) a weighted-average of the estimated weighted-average dumping margins calculated for the examined respondents; (B) a simple average of the estimated weighted-average dumping margins calculated for the examined respondents; and (C) a weighted-average of the estimated weighted-average dumping margins calculated for the examined respondents using each company's publicly-ranged U.S. sale quantities for the merchandise under consideration. The Department then compares (B) and (C) to (A) and selects the rate closest to (A) as the most appropriate rate for all other producers and exporters. See Ball Bearings and Parts Thereof from France, Germany, Italy, Japan, and the United Kingdom: Final Results of Antidumping Duty Administrative Reviews, Final Results of Changed-Circumstances Review, and Revocation of an Order in Part, 75 FR 53661, 53663 (September 1, 2010). As complete publicly ranged sales data was available, the Department based the all-others rate on the publicly ranged sales data of the mandatory respondents. For a complete analysis of the data, please see Memorandum to the File “Antidumping Duty Investigation of Biodiesel from Argentina: Preliminary Determsnation Calculation for the `All-Others' Rate,” October 19, 2017 (Preliminary All-Others Rate Memorandum).

    Preliminary Determination

    The Department preliminarily determines that the following estimated weighted-average dumping margins exist:

    Exporter or producer Estimated
  • weighted-average
  • dumping margin
  • (percent)
  • Cash deposit rate
  • (adjusted for
  • subsidy offset(s))
  • (percent)
  • LDC Argentina S.A 54.36 54.36 Vicentin S.A.I.C.9 70.05 10 69.91 All-Others 63.00 11 62.92
    Suspension of Liquidation

    9 The Department preliminarily determined that Vicentin S.A.I.C., and companies Renova S.A., Oleaginosa Moreno Hermanos S.A., Molinos Agro S.A., Patagonia Energia S.A., VFG Inversiones y Actividades Especiales S.A., Vicentin S.A.I.C. Sucursal Uy, Trading Company X, and Molinos Overseas Commodities S.A. are a single entity. See Preliminary Decision Memorandum at “Affiliation and Collapsing.”

    10See Vicentin Preliminary Analysis Memorandum.

    11See Preliminary All-Others Rate Memorandum.

    In accordance with section 733(d)(2) of the Act, the Department will direct U.S. Customs and Border Protection (CBP) to suspend liquidation of entries of subject merchandise, as described in Appendix I, entered, or withdrawn from warehouse, for consumption on or after the date of publication of this notice in the Federal Register. Furthermore, pursuant to section 733(d)(1)(B) of the Act and 19 CFR 351.205(d), the Department will instruct CBP to require a cash deposit equal to the estimated weighted-average dumping margin, adjusted for export subsidy offset(s), as follows: (1) The cash deposit rate for the respondents listed above will be equal to the company-specific estimated weighted-average dumping margins, adjusted for export subsidy offset(s), determined in this preliminary determination; (2) if the exporter is not a respondent identified above, but the producer is, then the cash deposit rate will be equal to the company-specific estimated weighted-average dumping margin, adjusted for export subsidy offset(s), established for that producer of the subject merchandise; and (3) the cash deposit rate for all other producers and exporters will be equal to the all-others estimated weighted-average dumping margin, adjusted for export subsidy offset(s).

    The Department normally adjusts cash deposits for estimated antidumping duties by the amount of export subsidies countervailed in a companion CVD proceeding in accordance with section 772(c)(1)(C), when CVD provisional measures are in effect. Accordingly, where the Department preliminarily made an affirmative determination for countervailable export subsidies, the Department has offset the estimated weighted-average dumping margin by the appropriate CVD rate. In the preliminary determination in the companion CVD investigation, the Department found that Vicentin had a countervailable export subsidy while LDC did not.12 Therefore, we preliminarily determine to adjust the cash deposit rate for the Vicentin Group and make no adjustments to the cash deposit rate for LDC in the Preliminary Determination.

    12See Biodiesel from Argentina: Preliminary Affirmative Countervailing Duty Determination and Preliminary Affirmative Critical Circumstances Determination, in Part, 82 FR 40748 (August 28, 2017), and accompanying Preliminary Decision Memorandum.

    Section 733(e)(2) of the Act provides that, given an affirmative determination of critical circumstances, any suspension of liquidation shall apply to unliquidated entries of subject merchandise entered, or withdrawn from warehouse, for consumption on or after the later of (a) the date which is 90 days before the date on which the suspension of liquidation was first ordered, or (b) the date on which notice of initiation of the investigation was published. The Department preliminarily finds that critical circumstances exist for imports of subject merchandise produced or exported by LDC and “all other” exporters and producers not individually examined. In accordance with section 733(e)(2)(A) of the Act, the suspension of liquidation shall apply to unliquidated entries of shipments of subject merchandise from the producer(s) or exporter(s) identified in this paragraph that were entered, or withdrawn from warehouse, for consumption on or after the date which is 90 days before the publication of this notice.

    These suspension of liquidation instructions will remain in effect until further notice.

    Disclosure

    The Department intends to disclose its calculations and analysis performed to interested parties in this preliminary determination within five days of any public announcement or, if there is no public announcement, within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b).

    Verification

    As provided in section 782(i)(1) of the Act, the Department intends to verify the information relied upon in making its final determination.

    Public Comment

    Case briefs or other written comments may be submitted to the Assistant Secretary for Enforcement and Compliance no later than seven days after the date on which the last verification report is issued in this investigation, 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.13 Pursuant to 19 CFR 351.309(c)(2) and (d)(2), parties who submit case briefs or rebuttal briefs in this investigation 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.

    13See 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.

    Final Determination

    Section 735(a)(1) of the Act and 19 CFR 351.210(b)(1) provide that the Department will issue the final determination within 75 days after the date of its preliminary determination. Accordingly, the Department will make its final determination no later than 75 days after the signature date of this preliminary determination.

    International Trade Commission Notification

    In accordance with section 733(f) of the Act, the Department will notify the International Trade Commission (ITC) of its preliminary determination. If the final determination is affirmative, the ITC will determine before the later of 120 days after the date of this preliminary determination or 45 days after the final determination whether these imports are materially injuring, or threaten material injury to, the U.S. industry.

    Notification to Interested Parties

    This determination is issued and published in accordance with sections 733(f) and 777(i)(1) of the Act and 19 CFR 351.205(c).

    Dated: October 19, 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 Investigation

    The product covered by this investigation is biodiesel, which is a fuel comprised of mono-alkyl esters of long chain fatty acids derived from vegetable oils or animal fats, including biologically-based waste oils or greases, and other biologically-based oil or fat sources. The investigation cover biodiesel in pure form (B100) as well as fuel mixtures containing at least 99 percent biodiesel by volume (B99). For fuel mixtures containing less than 99 percent biodiesel by volume, only the biodiesel component of the mixture is covered by the scope of the investigation.

    Biodiesel is generally produced to American Society for Testing and Materials International (ASTM) D6751 specifications, but it can also be made to other specifications. Biodiesel commonly has one of the following Chemical Abstracts Service (CAS) numbers, generally depending upon the feedstock used: 67784-80-9 (soybean oil methyl esters); 91051-34-2 (palm oil methyl esters); 91051-32-0 (palm kernel oil methyl esters); 73891-99-3 (rapeseed oil methyl esters); 61788-61-2 (tallow methyl esters); 68990-52-3 (vegetable oil methyl esters); 129828-16-6 (canola oil methyl esters); 67762-26-9 (unsaturated alkylcarboxylic acid methyl ester); or 68937-84-8 (fatty acids, C12-C18, methyl ester).

    The B100 product subject to the investigation is currently classifiable under subheading 3826.00.1000 of the Harmonized Tariff Schedule of the United States (HTSUS), while the B99 product is currently classifiable under HTSUS subheading 3826.00.3000. Although the HTSUS subheadings, ASTM specifications, and CAS numbers are provided for convenience and customs purposes, the written description of the scope is dispositive.

    Appendix II List of Topics Discussed in the Preliminary Decision Memorandum I. Summary II. Background III. Period of Investigation IV. Preliminary Affirmative Critical Circumstances, In Part A. Legal Framework B. Critical Circumstances Allegation C. Analysis V. Affiliation and Collapsing A. Vicentin Group VI. Discussion of the Methodology A. Comparisions to Fair Value VII. Product Comparisons VIII. Date of Sale IX. Export Price and Constructed Export Price X. Normal Value A. Market Viability XI. Particular Market Situation A. Background B. Interest Parties' Arguments C. Analysis XII. Calculation of Normal Value Based on Constructed Value XIII. Circumstance of Sale Adjustment XIV. Adjustment to Cash Deposit Rate for Export Subsidies XV. Currency Conversion XVI. Conclusion
    [FR Doc. 2017-23601 Filed 10-30-17; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-412-826] Carbon and Alloy Steel Wire Rod From the United Kingdom: Preliminary Affirmative Determination of Sales at Less Than Fair Value, and Preliminary Affirmative Determination of Critical Circumstances AGENCY:

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

    SUMMARY:

    The Department of Commerce (the Department) preliminarily determines that carbon and alloy steel wire rod (wire rod) from the United Kingdom is being, or is likely to be, sold in the United States at less than fair value (LTFV). The period of investigation (POI) is January 1, 2016, through December 31, 2016.

    DATES:

    Applicable October 31, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Alice Maldonado, 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) 482-4682.

    SUPPLEMENTARY INFORMATION: Background

    This preliminary determination is made in accordance with section 733(b) of the Tariff Act of 1930, as amended (the Act). The Department published the notice of initiation of this investigation on April 26, 2017.1 On August 21, 2017, the Department postponed the preliminary determination of this investigation and the revised deadline is now October 24, 2017.2 For a complete description of the events that followed the initiation of this investigation, see the Preliminary Decision Memorandum.3 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, 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 and the electronic versions of the Preliminary Decision Memorandum are identical in content.

    1See Carbon and Alloy Steel Wire Rod from Belarus, Italy, the Republic of Korea, the Russian Federation, South Africa, Spain, the Republic of Turkey, Ukraine,United Arab Emirates, and the United Kingdom: Initiation of Less-Than-Fair-Value Investigations, 82 FR 19207 (April 26, 2017) (Initiation Notice).

    2See Carbon and Alloy Steel Wire Rod from Italy, the Republic of South Africa, Spain, the Republic of Turkey, Ukraine and the United Kingdom: Postponement of Preliminary Determinations in the Less-Than-Fair-Value Investigations, 82 FR 39564 (August 21, 2017).

    3See Memorandum, “Decision Memorandum for the Preliminary Determination in the Antidumping Duty Investigation of Carbon and Alloy Steel Wire Rod from the United Kingdom” dated concurrently with, and hereby adopted by, this notice (Preliminary Decision Memorandum).

    Scope of the Investigation

    The products covered by this investigation are wire rod from the United Kingdom. For a complete description of the scope of this investigation, see Appendix I.

    Scope Comments

    In accordance with the preamble to the Department's regulations,4 the Initiation Notice set aside a period of time for parties to raise issues regarding product coverage (i.e., scope).5 Certain interested parties commented on the scope of the investigation as it appeared in the Initiation Notice. For a summary of the product coverage comments and rebuttal responses submitted to the record for this investigation, and accompanying discussion and analysis of all comments timely received, see the Preliminary Scope Decision Memorandum.6 Since the issuance of the Preliminary Scope Decision Memorandum, certain parties submitted scope case briefs or scope rebuttal briefs.7 The Department will issue a final scope decision on the records of the wire rod investigations after considering those comments submitted in scope case and rebuttal briefs.

    4See Antidumping Duties; Countervailing Duties, Final Rule, 62 FR 27296, 27323 (May 19, 1997).

    5See Initiation Notice.

    6See Memorandum, “Carbon and Alloy Steel Wire Rod from Belarus, Italy, the Republic of Korea, the Russian Federation, South Africa, Spain, the Republic of Turkey, Ukraine, the United Arab Emirates, and the United Kingdom: Scope Comments Decision Memorandum for the Preliminary Determination” (Preliminary Scope Decision Memorandum), dated August 7, 2017.

    7See Preliminary Decision Memorandum.

    Methodology

    The Department is conducting this investigation in accordance with section 731 of the Act. The Department selected two respondents in this investigation, British Steel Limited (British Steel) and Longs Steel UK Limited (Longs Steel). British Steel submitted information on the record of this investigation demonstrating that it purchased Longs Steel during the POI. British Steel also submitted information supporting its claim that it operates essentially as a new company. After analyzing this information, the Department preliminarily finds that British Steel is not the successor-in-interest to Longs Steel. For further discussion, see the Preliminary Decision Memorandum and the Successor-In-Interest Analysis Memo.8

    8See Memorandum, “Antidumping Duty Investigation of Carbon and Alloy Steel Wire Rod from the United Kingdom: Preliminary Successor-In-Interest Determination,” dated concurrently with this preliminary determination.

    With respect to British Steel, the Department has calculated export prices in accordance with section 772(a) of the Act. Normal value (NV) is calculated in accordance with section 773 of the Act. Furthermore, pursuant to section 776(a) and (b) of the Act, the Department has preliminarily relied upon facts otherwise available, with an adverse inference, for Longs Steel. For a full description of the methodology underlying the preliminary determination, see the Preliminary Decision Memorandum.

    Preliminary Affirmative Determination of Critical Circumstances

    In accordance with section 733(e) of the Act and 19 CFR 351.206, the Department preliminarily finds that critical circumstances exist for British Steel, Longs Steel, and all other producers/exporters. For a full description of the methodology and results of the Department's critical circumstances analysis, see the Preliminary Decision Memorandum.

    All-Others Rate

    Sections 733(d)(1)(A)(ii) and 735(c)(5)(A) of the Act provide that in the preliminary determination the Department shall determine an estimated all-others rate for all exporters and producers not individually examined. This rate shall be an amount equal to the weighted average of the estimated weighted-average dumping margins established for exporters and producers individually investigated, excluding any zero and de minimis margins, and any margins determined entirely under section 776 of the Act.

    In this investigation, the Department preliminarily assigned a rate based entirely on facts available to Longs Steel. Therefore, the only rate that is not zero, de minimis or based entirely on facts otherwise available is the rate calculated for British Steel. Consequently, the rate calculated for British Steel is also assigned as the rate for all-other producers and exporters.

    Preliminary Determination

    The Department preliminarily determines that the following estimated weighted-average dumping margins exist:

    Exporter/producer Estimated
  • weighted-
  • average
  • dumping
  • margin
  • (percent)
  • British Steel Limited 41.96 Longs Steel Longs Steel UK Limited 147.63 All-Others 41.96
    Suspension of Liquidation

    In accordance with section 733(d)(2) of the Act, the Department will direct U.S. Customs and Border Protection (CBP) to suspend liquidation of entries of subject merchandise, as described in Appendix I, entered, or withdrawn from warehouse, for consumption on or after the date of publication of this notice in the Federal Register. Further, pursuant to section 733(d)(1)(B) of the Act and 19 CFR 351.205(d), the Department will instruct CBP to require a cash deposit equal to the estimated weighted-average dumping margin or the estimated all-others rate, as follows: (1) The cash deposit rate for the respondents listed above will be equal to the company-specific estimated weighted-average dumping margins determined in this preliminary determination; (2) if the exporter is not a respondent identified above, but the producer is, then the cash deposit rate will be equal to the company-specific estimated weighted-average dumping margin established for that producer of the subject merchandise; and (3) the cash deposit rate for all other producers and exporters will be equal to the all-others estimated weighted-average dumping margin.

    Section 733(e)(2) of the Act provides that, given an affirmative determination of critical circumstances, any suspension of liquidation shall apply to unliquidated entries of subject merchandise entered, or withdrawn from warehouse, for consumption on or after the later of (a) the date which is 90 days before the date on which the suspension of liquidation was first ordered, or (b) the date on which notice of initiation of the investigation was published. The Department preliminarily finds that critical circumstances exist for imports of subject merchandise produced or exported by British Steel, Longs Steel, and all other exporters. In accordance with section 733(e)(2)(A) of the Act, the suspension of liquidation shall apply to unliquidated entries of shipments of subject merchandise from the producer(s) or exporter(s) that were entered, or withdrawn from warehouse, for consumption on or after the date which is 90 days before the publication of this notice. These suspension of liquidation instructions will remain in effect until further notice.

    Disclosure

    The Department intends to disclose its calculations and analysis performed to interested parties in this preliminary determination within five days of any public announcement or, if there is no public announcement, within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b).

    Verification

    As provided in section 782(i)(1) of the Act, the Department intends to verify the information relied upon in making its final determination.

    Public Comment

    Case briefs or other written comments may be submitted to the Assistant Secretary for Enforcement and Compliance no later than seven days after the date on which the last verification report is issued in this investigation.

    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.

    Final Determination

    Section 735(a)(1) of the Act and 19 CFR 351.210(b)(1) provide that the Department will issue the final determination within 75 days after the date of its preliminary determination. Accordingly, the Department will make its final determination no later than 75 days after the signature date of this preliminary determination.

    International Trade Commission Notification

    In accordance with section 733(f) of the Act, the Department will notify the International Trade Commission (ITC) of its preliminary determination. If the final determination is affirmative, the ITC will determine before the later of 120 days after the date of this preliminary determination or 45 days after the final determination whether these imports are materially injuring, or threaten material injury to, the U.S. industry.

    Notification to Interested Parties

    This determination is issued and published in accordance with sections 733(f) and 777(i)(1) of the Act and 19 CFR 351.205(c).

    Dated: October 24, 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 Investigation

    The products covered by this investigation are certain hot-rolled products of carbon. Specifically excluded are steel products possessing the above-noted physical characteristics and meeting the Harmonized Tariff Schedule of the United States (HTSUS) definitions for (a) stainless steel; (b) tool steel; (c) high-nickel steel; (d) ball bearing steel; or (e) concrete reinforcing bars and rods. Also excluded are free cutting steel (also known as free machining steel) products (i.e., products that contain by weight one or more of the following elements: 0.1 percent of more of lead, 0.05 percent or more of bismuth, 0.08 percent or more of sulfur, more than 0.04 percent of phosphorous, more than 0.05 percent of selenium, or more than 0.01 percent of tellurium). All products meeting the physical description of subject merchandise that are not specifically excluded are included in this scope.

    The products under investigation are currently classifiable under subheadings 7213.91.3011, 7213.91.3015, 7213.91.3020, 7213.91.3093, 7213.91.4500, 7213.91.6000, 7213.99.0030, 7227.20.0030, 7227.20.0080, 7227.90.6010, 7227.90.6020, 7227.90.6030, and 7227.90.6035 of the HTSUS. Products entered under subheadings 7213.99.0090 and 7227.90.6090 of the HTSUS may also be included in this scope if they meet the physical description of subject merchandise above. Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of the scope of these proceedings is dispositive.

    Appendix II List of Topics Discussed in the Preliminary Decision Memorandum I. Summary II. Background III. Period of Investigation IV. Scope Comments V. Successor-In-Interest VI. Discussion of the Methodology A. Determination of Comparison Method B. Results of the Differential Pricing Analysis VII. Date of Sale VIII. Product Comparisons IX. Export Price X. Normal Value A. Home Market Viability B. Level of Trade C. Cost of Production (COP) Analysis 1. Calculation of COP 2. Test of Comparison Market Sales Prices 3. Results of the COP Test D. Calculation of NV Based on Comparison Market Prices E. Calculation of NV Based on Constructed Value XI. Application of Facts Available and Use of Adverse Inference A. Application of Facts Available B. Use of Adverse Inference C. Selection and Corroboration of the AFA Rate XII. Critical Circumstances XIII. Currency Conversion XIV. Conclusion
    [FR Doc. 2017-23651 Filed 10-30-17; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-427-602; A-428-602; A-475-601; A-588-704] Brass Sheet and Strip From France, Germany, Italy, and Japan: Continuation of Antidumping Duty Orders AGENCY:

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

    SUMMARY:

    As a result of the determination by the Department of Commerce (the Department) and the International Trade Commission (ITC) that revocation of the antidumping duty (AD) orders on brass sheet and strip from France, Germany, Italy, and Japan would likely lead to a continuation or recurrence of dumping and material injury to an industry in the United States, the Deparment is publishing a notice of continuation of the AD orders.

    DATES:

    Applicable October 31, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Aimee Phelan, AD/CVD Operations, Office I, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-0697.

    SUPPLEMENTARY INFORMATION: Background

    On March 6, 1987, the Department published in the Federal Register the AD orders on brass sheet and strip from France, Germany, and Italy.1 On September 23, 1988, the Department amended the AD order with respect to brass sheet and strip from Germany.2 Similarly, on May 21, 1991, the Department amended the AD order with respect to brass sheet and strip from Italy.3 On August 12, 1988, the Department issued an AD order on imports of brass sheet and strip from Japan.4

    1See Antidumping Duty Order: Brass Sheet and Strip from France, 52 FR 6995 (March 6, 1987); Antidumping Duty Order: Brass Sheet and Strip from Italy, 52 FR 6997 (March 6, 1987); See Antidumping Duty Order; Brass Sheet and Strip from the Federal Republic of Germany, 52 FR 35750 (March 6, 1987).

    2See Antidumping Duty Order; Brass Sheet and Strip from the Federal Republic of Germany, 52 FR 35750 (March 6, 1987), amended at Final Determination of Sales at Less Than Fair Value and Amendment to Antidumping Duty Order: Brass Sheet and Strip from the Federal Republic of Germany, 52 FR 35750 (September 23, 1987).

    3See Amendment to Final Determination of Sales at Less Than Fair Value and Amendment of Antidumping Duty Order in Accordance with Decision Upon Remand: Brass Sheet and Strip from Italy, 56 FR 23272 (May 21, 1991).

    4See Antidumping Duty Order: Brass Sheet and Strip from Japan, 53 FR 30454 (August 12, 1988).

    On March 3, 2017, the Department published the notice of initiation of the fourth sunset reviews of these AD orders on brass sheet and strip 5 from France, Germany, Italy, and Japan pursuant to section 751(c) of the Tariff Act of 1930, as amended (the Act).

    5See Initiation of Five-Year (“Sunset”) Reviews, 82 FR 12438 (March 3, 2017) (Initiation).

    The Department conducted these sunset reviews on an expedited basis, pursuant to section 751(c)(3)(B) of the Act and 19 CFR 351.218(e)(1)(ii)(C)(2), because it received a complete and adequate response from the domestic interested pastries, but no substantive responses from respondent interested parties. As a result of these expedited sunset reviews, the Department determined that revocation of the AD orders on brass sheet and strip from France, Germany, Italy, and Japan would likely lead to continuation or recurrence of dumping and, therefore, notified the ITC of the magnitude of the margins likely to prevail should the orders be revoked.6

    6See Brass Sheet and Strip from France, Germany, Italy, and Japan: Final Results of the Expedited Fourth Sunset Review of the Antidumping Duty Orders, 82 FR 31046 (July 5, 2017).

    On October 19, 2017, pursuant to sections 751(c) and 752(a) of the Act, the ITC published a notice of its determination that revocation of the AD orders on brass sheet and strip from France, Germany, Italy, and Japan would likely lead to continuation or recurrence of material injury to an industry in the United States within a reasonably foreseeable time.7

    7See Brass Sheet and Strip from France, Germany, Italy, and Japan; Determinations, 82 FR 48724 (October 19, 2017) and ITC Publication titled Brass Sheet and Strip from France, Germany, Italy, and Japan: Investigtion Nos. 731-TA-313-314, 317 and 379 (Fourth Review) (October 2017).

    Scope of the Orders

    The product covered by the orders is brass sheet and strip, other than leaded and tinned brass sheet and strip, from France, Germany, Italy, and Japan. The chemical composition of the covered product is currently defined in the Copper Development Association (“C.D.A.”) 200 Series or the Unified Numbering System (“U.N.S.”) C2000. The orders do not cover products the chemical compositions of which are defined by other C.D.A. or U.N.S. series. In physical dimensions, the product covered by the orders has a solid rectangular cross section over 0.006 inches (0.15 millimeters) through 0.188 inches (4.8 millimeters) in finished thickness or gauge, regardless of width. Coiled, wound-on-reels (traverse wound), and cut-to-length products are included. The merchandise is currently classified under Harmonized Tariff Schedule of the United States (“HTSUS”) item numbers 7409.21.00 and 7409.29.00.

    Although the HTSUS item numbers are provided for convenience and customs purposes, the written description of the scope of the orders remains dispositive.

    Continuation of the Orders

    As a result of the determinations by the Department and the ITC that revocation of the AD orders would likely lead to continuation or recurrence of dumping and material injury to an industry in the United States, pursuant to section 751(d)(2) of the Act and 19 CFR 351.218(a), the Department hereby orders the continuation of the AD orders on brass sheet and strip from France, Germany, Italy, and Japan.

    U.S. Customs and Border Protection will continue to collect AD cash deposits at the rates in effect at the time of entry for all imports of subject merchandise. The effective date of continuation of these orders will be the date of publication in the Federal Register of this notice of continuation. Pursuant to section 751(c)(2) of the Act, the Department intends to initiate the next five-year review of these orders not later than 30 days prior to the fifth anniversary of the effective date of continuation.

    These five-year sunset reviews and this notice are in accordance with section 751(c) of the Act and published pursuant to section 777(i)(1) of the Act, and 19 CFR 351.218(f)(4).

    Dated: October 24, 2017. Gary Taverman, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, performing the non-exclusive functions and duties of the Assistant Secretary for Enforcement and Compliance.
    [FR Doc. 2017-23642 Filed 10-30-17; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XF797 New England Fishery Management Council; Public Meeting AGENCY:

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

    ACTION:

    Notice; public meeting.

    SUMMARY:

    The New England Fishery Management Council (Council) is scheduling a public meeting of its Herring Advisory Panel to consider actions affecting New England fisheries in the exclusive economic zone (EEZ). Recommendations from this group will be brought to the full Council for formal consideration and action, if appropriate.

    DATES:

    This meeting will be held on Monday, November 20, 2017 at 10 a.m.

    ADDRESSES:

    The meeting will be held at the Holiday Inn, 700 Myles Standish Blvd., Taunton, MA 02780; telephone: (508) 823-0430.

    Council Address: New England Fishery Management Council, 50 Water Street, Mill 2, Newburyport, MA 01950.

    FOR FURTHER INFORMATION CONTACT:

    Thomas A. Nies, Executive Director, New England Fishery Management Council; telephone: (978) 465-0492.

    SUPPLEMENTARY INFORMATION:

    Agenda

    The Advisory Panel will review analyses prepared for Herring Amendment 8 Draft Environmental Impact Statement (DEIS) specific to the range of alternatives developed to address potential localized depletion and user conflicts in the herring fishery. The panel may identify preferred alternatives for the Committee to consider the following day. The panel is not scheduled to discuss the other measures under consideration in Amendment 8, Acceptable Biological Catch (ABC) control rule alternatives. The Council reviewed the ABC control rule alternatives at the September 2017 meeting and declined to select a preferred alternative, but approved that portion of Amendment 8 to proceed for submission and public comment. They will discuss recommendations for the Committee to consider for Herring Research Set-Aside research priorities for fishing years 2019-21 and discuss any challenges the program has had in recent years. They will discuss other business, as necessary.

    Although non-emergency issues not contained in this agenda may come before this group for discussion, those issues may not be the subject of formal action during these meetings. Action will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Act, provided the public has been notified of the Council's intent to take final action to address the emergency.

    Special Accommodations

    This meeting is physically accessible to people with disabilities. This meeting will be recorded. Consistent with 16 U.S.C. 1852, a copy of the recording is available upon request. Requests for sign language interpretation or other auxiliary aids should be directed to Thomas A. Nies, Executive Director, at (978) 465-0492, at least 5 days prior to the meeting date.

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: October 25, 2017. Tracey L. Thompson, Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2017-23592 Filed 10-30-17; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XF540 Takes of Marine Mammals Incidental to Specified Activities; Taking Marine Mammals Incidental to the Biorka Island Dock Replacement Project AGENCY:

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

    ACTION:

    Notice; issuance of an incidental harassment authorization.

    SUMMARY:

    In accordance with the regulations implementing the Marine Mammal Protection Act (MMPA) as amended, notification is hereby given that NMFS has issued an incidental harassment authorization (IHA) to the Federal Aviation Administration (FAA) to incidentally harass, by Level A and Level B harassment, marine mammals during construction activities associated with the Biorka dock replacement project in Symonds Bay, AK.

    DATES:

    This Authorization is applicable from May 1, 2018, through April 30, 2019.

    FOR FURTHER INFORMATION CONTACT:

    Shane Guan, Office of Protected Resources, NMFS, (301) 427-8401. Electronic copies of the applications and supporting documents, as well as a list of the references cited in this document, may be obtained online at: www.nmfs.noaa.gov/pr/permits/incidental/construction.htm. In case of problems accessing these documents, please call the contact listed above.

    SUPPLEMENTARY INFORMATION:

    Background

    Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361 et seq.) direct the Secretary of Commerce (as delegated to NMFS) to allow, upon request, the incidental, but not intentional, taking of small numbers of marine mammals by U.S. citizens who engage in a specified activity (other than commercial fishing) within a specified geographical region if certain findings are made and either regulations are issued or, if the taking is limited to harassment, a notice of a proposed authorization is provided to the public for review.

    An Incidental Take Authorization (ITA) shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s), will not have an unmitigable adverse impact on the availability of the species or stock(s) for subsistence uses (where relevant), and if the permissible methods of taking and requirements pertaining to the mitigation, monitoring and reporting of such takings are set forth.

    NMFS has defined “negligible impact” in 50 CFR 216.103 as an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival.

    The MMPA states that the term “take” means to harass, hunt, capture, kill or attempt to harass, hunt, capture, or kill any marine mammal.

    Except with respect to certain activities not pertinent here, the MMPA defines “harassment” as any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild (Level A harassment); or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering (Level B harassment).

    National Environmental Policy Act

    To comply with the National Environmental Policy Act (NEPA) of 1969 (NEPA; 42 U.S.C. 4321 et seq.) and NOAA Administrative Order (NAO) 216-6A, NMFS must review our proposed action (i.e., the issuance of an incidental harassment authorization) with respect to environmental consequences on the human environment. This action is consistent with categories of activities identified in CE B4 of the Companion Manual for NOAA Administrative Order 216-6A, which do not individually or cumulatively have the potential for significant impacts on the quality of the human environment and for which we have not identified any extraordinary circumstances that would preclude this categorical exclusion. Accordingly, NMFS has determined that the issuance of the IHA qualifies to be categorically excluded from further NEPA review and a Categorical Exclusion memo was signed in October 2017.

    Summary of Request

    On March 31, 2017, NMFS received a request from the FAA for an IHA to take marine mammals incidental to pile driving and removal and down the hole (DTH) drilling in association with the Biorka Island Dock Replacement Project (Project) in Symonds Bay, Alaska. The FAA's request is for take of five species by Level A and Level B harassment. Neither the FAA nor NMFS expect mortality to result from this activity and, therefore, an IHA is appropriate.

    In-water work associated with the in-water construction is expected to be completed within 70 days starting May 1, 2018. We expect the in-water construction work to occur between May 1, 2018 through September 30, 2018; however, this IHA is valid for one year, from May 1, 2018, through April 30, 2019.

    Description of the Specified Activity Overview

    The FAA is constructing a replacement dock on Biorka Island in Symonds Bay near Sitka, Alaska. The purpose of the Project is to improve and maintain the sole point of access to Biorka Island and the navigational and weather facilities located on the island. The existing dock has deteriorated and reached the end of its useful life. Regular and repetitive heavy surging seas, along with constant use have destroyed the face of the existing floating marine dock, and have broken cleats making it difficult to tie a vessel to the existing dock. In its present condition, small vessels cannot use the dock to provide supplies to facilities on the island. The existing barge landing area is reinforced seasonally by adding fill to the landing at the shoreline, which is periodically washed away by storms and wave action. The Project would reconstruct the deteriorated existing dock and construct an improved barge landing area. A detailed description of the planned dock replacement project is provided in the Federal Register notice for the proposed IHA (82 FR 41229; August 30, 2017). Since that time, no changes have been made to the planned activities. Therefore, a detailed description is not provided here. Please refer to that Federal Register notice for the description of the specific activity.

    Table 1 provides a summary of the six methods of construction (“scenarios”) used in the modeling of the zone of influence (ZOI)s for the Biorka Project. The ZOIs effectively represent the mitigation zone that would be established around each pile to prevent Level A harassment to marine mammals, while providing estimates of the areas within which Level B harassment might occur.

    Table 1—Pile Driving Modeling Scenarios for the Biorka Project Scenario Description Piles
  • installed
  • per day
  • Vibratory Hrs per pile Total
  • hours
  • per
  • day
  • DTH Hours
  • per pile
  • Total
  • hours
  • per day
  • Impact Hours
  • per pile
  • Total
  • strikes
  • per day
  • Shift
  • (hr)
  • S1 Removal of existing piles and installation/removal of temporary piles 1 21 0.33 6.93 NA 2 NA 2 6.93 S2 Installation of 18-inch pipe piles (dock and dolphin) 3 0.99 2 6 0.17 15 7.49 S3 Installation of 18-inch pipe piles (barge landing) 4 1.32 NA 0.33 2720 2.65 S4 Installation of 30-inch pipe piles (dolphins) 2 0.66 2 4 0.17 10 4.99 S5 Installation of H piles (dock wave barrier) 8 2.64 NA 2 0.33 5440 5.31 S6 Installation of sheet piles (dock wave barrier and barge landing) 12 3.96 NA 2 0.25 6120 6.96 1 Existing piles to be removed include 3 24-in concrete piles, 14 8-in steel piles, 8 10-in steel piles, 14 12.75-in steel piles, and 7 14- to 8-in timber piles. 2 NA indicates when a pile driving method was not required in a given scenario.
    Comment and Responses

    A notice of NMFS's proposal to issue an IHA to the FAA was published in the Federal Register on August 30, 2017 (82 FR 41229). That notice described, in detail, the FAA's activity, the marine mammal species that may be affected by the activity, and the anticipated effects on marine mammals. During the 30-day public comment period, NMFS received comments from the Marine Mammal Commission (Commission).

    Comment 1: The Commission has concerns regarding the appropriateness of the manner in which NMFS has estimated Level A harassment zones. The Commission recommends that NMFS consult with both internal and external scientists and acousticians to determine the appropriate accumulation time that action proponents should use to determine the extent of the Level A harassment zones based on the associated permanent threshold shift (PTS) cumulative sound exposure level (SELcum) thresholds for the various types of sound sources, including stationary sound sources, when simple area x density methods are employed. Estimated swimming speeds of various species and behavior patterns (including residency patterns) should be considered, and multiple scenarios should be evaluated using animat modeling.

    Response: NMFS will take the Commission's recommendation into consideration and will consult with internal scientists on this issue in the future; however it does not change our isopleths or the number of takes for this specific action. We also welcome the Commission and its Committee of Scientific Advisors on Marine Mammals to provide guidance on this issue.

    Comment 2: The Commission is unsure why NMFS is not implementing consistent measures for action proponents that plan to conduct similar activities (e.g. shutdowns for vibratory driving and DTH drilling). The Commission recommends that NMFS (1) determine whether action proponents would be required to implement delay or shut-down procedures during use of vibratory and down-the-hole hammers and (2) require, or refrain from requiring, those measures consistently for all authorizations involving those activities.

    Response: NMFS has confirmed that the FAA will be required to implement shutdown and delay procedures during the use of all construction equipment, including vibratory driving and removal and DTH drilling. In the future, NMFS will ensure consistency across all authorizations in our mitigation requirements.

    Comment 3: The Commission recommended that NMFS share the rounding criteria with the Commission such that the matter of when rounding should occur in the take calculation can be resolved in the near future.

    Response: NMFS will share the rounding criteria with the Commission soon and looks forward to working with them in the future to resolve this issue.

    Description of Marine Mammals in the Area of the Specified Activity

    There are five marine mammal species that may transit through the waters nearby the Project area, and are likely to potentially be taken by the specified activity. These include the Steller sea lion (Eumetopias jubatus), harbor seal (Phoca vitulina), harbor porpoise (Phocoena phocoena), killer whale (Orcinus orca), and humpback whale (Megaptera noviaeangliae). Multiple additional marine mammal species may occasionally enter Sitka sound but are not expected to be present in the shallow nearshore waters of the action area.

    Sections 3 and 4 of the FAA's application summarize available information regarding status and trends, distribution and habitat preferences, and behavior and life history of the potentially affected species. Additional information regarding population trends and threats may be found in NMFS's Stock Assessment Reports (SAR; www.nmfs.noaa.gov/pr/sars/) and more general information about these species (e.g., physical and behavioral descriptions) may be found on NMFS's Web site (www.nmfs.noaa.gov/pr/species/mammals/).

    Table 2 lists all species with expected occurrence in Symonds Bay and Sitka Sound and summarizes information related to the population or stock, including potential biological removal (PBR), where known. For taxonomy, we follow Committee on Taxonomy (2016). PBR is defined by the MMPA as the maximum number of animals, not including natural mortalities, that may be removed from a marine mammal stock while allowing that stock to reach or maintain its optimum sustainable population (as described in NMFS's SARs). While no mortality is anticipated or authorized here, PBR and annual serious injury and mortality are included here as gross indicators of the status of the species and other threats.

    A detailed description of the of the species likely to be affected by the Project, including brief introductions to the species and relevant stocks as well as available information regarding population trends and threats, and information regarding local occurrence, were provided in the Federal Register notice for the proposed IHA (82 FR 41229; August 30, 2017); since that time, we are not aware of any changes in the status of these species and stocks; therefore, detailed descriptions are not provided here. Please refer to that Federal Register notice for these descriptions. Please also refer to NMFS' Web site (www.nmfs.noaa.gov/pr/species/mammals/) for generalized species accounts.

    Table 2—Marine Mammals Potentially Present in the Vicinity of Biorka Island Species Stock ESA/MMPA
  • status;
  • strategic
  • (Y/N) 1
  • Stock abundance (CV, Nmin, most recent abundance survey) 2 PBR 3 Annual
  • M/SI 4
  • Relative occurrence in Symonds Bay and Sitka Sound; season of occurrence
    Order Cetartiodactyla—Cetacea—Superfamily Odontoceti (toothed whales, dolphins, and porpoises) Family Phocoenidae (porpoises) Harbor porpoise (Phocoena phocoena) Southeast Alaska -; Y 11,146 (0.242; n/a; 1997) Undet. 34 Common. Order Cetartiodactyla—Cetacea—Superfamily Odontoceti (toothed whales, dolphins, and porpoises) Family Delphinidae (dolphins) Killer whale (Orcinus orca) Eastern North Pacific Gulf of Alaska, Aleutian Island, and Bering Sea Transient -; N 587 (n/a; 587; 2012) 0 0 Infrequent. West Coast Transient -; N 243 (n/a; 243; 2009) 2.4 0 Order Cetartiodactyla—Cetacea—Superfamily Mysticeti (baleen whales) Family Balaenopteridae Humpback whale 5 (Megaptera novaeangliae) Central North Pacific stock -; Y 10,103 (0.300; 7,890; 2006) 83 24 Likely. Order Carnivora—Superfamily Pinnipedia Family Otariidae (eared seals and sea lions) Steller sea lion (Eumetopias jubatus) Western E; Y 49,497 (n/a; 49,497; 2014) 297 236 Common. Eastern -; N 60,131 (n/a; 36,551; 2013) 1,645 108 Family Phocidae (earless seals) Harbor seal (Phoca vitulina) Sitka/Chatham -; N 14,855 (n/a; 13,212; 2011) 155 77 Common. 1 Endangered Species Act (ESA) status: Yes (Y), No (N), Endangered (E), Threatened (T)/Marine Mammal Protection Act (MMPA) status: Depleted (D). A dash (-) indicates that the species is not listed under the ESA or designated as depleted under the MMPA. Under the MMPA, a strategic stock is one for which the level of direct human-caused mortality exceeds PBR (see footnote 3) or which is determined to be declining and likely to be listed under the ESA within the foreseeable future. Any species or stock listed under the ESA is automatically designated under the MMPA as depleted and as a strategic stock. 2 CV is coefficient of variation; Nmin is the minimum estimate of stock abundance. In some cases, CV is not applicable. For certain stocks, abundance estimates are actual counts of animals and there is no associated CV. The most recent abundance survey that is reflected in the abundance estimate is presented; there may be more recent surveys that have not yet been incorporated into the estimate. 3 Potential biological removal, defined by the MMPA as the maximum number of animals, not including natural mortalities, that may be removed from a marine mammal stock while allowing that stock to reach or maintain its optimum sustainable population size (OSP). 4 These values, found in NMFS's SARs, represent annual levels of human-caused mortality plus serious injury from all sources combined (e.g, commercial fisheries, ship strike). Annual M/SI often cannot be determined precisely and is in some cases presented as a minimum value or range. A CV associated with estimated mortality due to commercial fisheries is presented in some cases. 5 The humpback whales considered under the MMPA to be part of this stock could be from any of two different distinct population segment (DPS)s. In Alaska, it would be expected to primarily be whales from the Hawaii DPS but could also be whales from Mexico DPS.
    Potential Effects of the Specified Activity on Marine Mammals and Their Habitat

    The effects of underwater noise from construction activities for the Project have the potential to result in behavioral harassment of marine mammals in the vicinity of the action area. The Federal Register notice for the proposed IHA (82 FR 41229; August 30, 2017) included a discussion of the effects of anthropogenic noise on marine mammals, therefore that information is not repeated here; please refer to that Federal Register notice for that information.

    Estimated Take by Incidental Harassment

    This section provides an estimate of the number of incidental takes authorized through this IHA, which informed NMFS' consideration of both the “small numbers” and the negligible impact determination.

    Harassment is the only type of take expected to result from these activities. Except with respect to certain activities not pertinent here, section 3(18) of the MMPA defines “harassment” as: Any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild (Level A harassment); or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering (Level B harassment).

    Authorized takes would be by Level A and Level B harassment, in the form of disruption of behavioral patterns for individual marine mammals resulting from exposure to vibratory and impact pile driving and removal and DTH drilling, and potential PTS for animals that may transit through the Level A zones (described below) undetected (Table 6). Based on the nature of the activity and the anticipated effectiveness of the mitigation measures (i.e., soft start, ramp-up, etc.—discussed in detail below in Mitigation Measures section), Level A harassment is not anticipated; however, a small number of takes by Level A harassment is authorized for most species as a precaution if animals go undetected before a shutdown is in place.

    As described previously, no mortality or serious injury is anticipated or authorized for this activity. Below we describe how the take is estimated.

    Described in the most basic way, we estimate take by considering: (1) Acoustic thresholds above which NMFS believes the best available science indicates marine mammals will be behaviorally harassed or incur some degree of permanent hearing impairment; (2) the area or volume of water that will be ensonified above these levels in a day; (3) the density or occurrence of marine mammals within these ensonified areas; and, (4) and the number of days of activities. Below, we describe these components in more detail and present the take estimate.

    The estimation of marine mammal takes typically uses the following calculation since site-specific density is unavailable:

    Level B exposure estimate = N (number of animals) in the area * Number of days of noise generating activities. Acoustic Thresholds

    Using the best available science, NMFS has developed acoustic thresholds that identify the received level of underwater sound above which exposed marine mammals would be reasonably expected to be behaviorally harassed (equated to Level B harassment) or to incur PTS of some degree (equated to Level A harassment).

    Level B Harassment for non-explosive sources—Though significantly driven by received level, the onset of behavioral disturbance from anthropogenic noise exposure is also informed to varying degrees by other factors related to the source (e.g., frequency, predictability, duty cycle), the environment (e.g., bathymetry), and the receiving animals (hearing, motivation, experience, demography, behavioral context) and can be difficult to predict (Southall et al., 2007, Ellison et al., 2011). Based on what the available science indicates and the practical need to use a threshold based on a factor that is both predictable and measurable for most activities, NMFS uses a generalized acoustic threshold based on received level to estimate the onset of behavioral harassment. NMFS predicts that marine mammals are likely to be behaviorally harassed in a manner we consider Level B harassment when exposed to underwater anthropogenic noise above received levels of 120 decibels (dB) re 1 micropascal (μPa) root mean square (rms) for continuous (e.g. vibratory pile-driving, drilling) and above 160 dB re 1 μPa (rms) for non-explosive impulsive (e.g., seismic airguns) or intermittent (e.g., scientific sonar) sources.

    The FAA's Project activities include the use of continuous (vibratory pile driving and DTH drilling) and impulsive (impact pile driving) sources, and therefore the 120 and 160 dB re 1 μPa (rms) are applicable.

    Level A harassment for non-explosive sources—NMFS' Technical Guidance for Assessing the Effects of Anthropogenic Sound on Marine Mammal Hearing (NMFS 2016) identifies dual criteria to assess auditory injury (Level A harassment) to five different marine mammal groups (based on hearing sensitivity) as a result of exposure to noise from two different types of sources (impulsive or non-impulsive). The FAA's Project activity includes the use of impulsive (impact pile driving) and non-impulsive (vibratory pile driving and DTH drilling) sources.

    These thresholds were developed by compiling and synthesizing the best available science and soliciting input multiple times from both the public and peer reviewers to inform the final product, and are provided in the table below. The references, analysis, and methodology used in the development of the thresholds are described in NMFS 2016 Technical Guidance, which may be accessed at: http://www.nmfs.noaa.gov/pr/acoustics/guidelines.htm.

    Table 3—Thresholds Identifying the Onset of Permanent Threshold Shift Hearing group PTS onset acoustic thresholds *
  • (received level)
  • Impulsive Non-impulsive
    Low-frequency cetaceans Cell 1: Lpk, flat: 219 dB; LE, LF, 24h: 183 dB Cell 2: LE, LF, 24h: 199 dB. Mid-frequency cetaceans Cell 3: Lpk, flat: 230 dB; LE, MF, 24h: 185 dB Cell 4: LE, MF, 24h: 198 dB. High-frequency cetaceans Cell 5: Lpk, flat: 202 dB; LE, HF, 24h: 155 dB Cell 6: LE, HF, 24h: 173 dB. Phocid Pinnipeds (underwaters) Cell 7: Lpk, flat: 218 dB; LE, PW, 24h: 185 dB Cell 8: LE, PW, 24h: 201 dB. Otariid Pinnipeds (underwater) Cell 9: Lpk, flat: 232 dB; LE, OW, 24h: 203 dB Cell 10: LE, OW, 24h: 219 dB. 1 NMFS 2016
    Ensonified Area

    Here, we describe operational and environmental parameters of the activity that will feed into identifying the area ensonified above the acoustic thresholds.

    Pile driving and removal and DTH drilling generates underwater noise that can potentially result in disturbance to marine mammals in the Project area. Transmission loss (TL) is the decrease in acoustic intensity as an acoustic pressure wave propagates out from a source. TL parameters vary with frequency, temperature, sea conditions, current, source and receiver depth, water depth, water chemistry, and bottom composition and topography. The general formula for underwater TL is:

    TL = B * log10(R1/R2), Where: R1 = the distance of the modeled SPL from the driven pile, and R2 = the distance from the driven pile of the initial measurement. This formula neglects loss due to scattering and absorption, which is assumed to be zero here. The degree to which underwater sound propagates away from a sound source is dependent on a variety of factors, most notably the water bathymetry and presence or absence of reflective or absorptive conditions including in-water structures and sediments. Spherical spreading occurs in a perfectly unobstructed (free-field) environment not limited by depth or water surface, resulting in a 6 dB reduction in sound level for each doubling of distance from the source (20*log[range]). Cylindrical spreading occurs in an environment in which sound propagation is bounded by the water surface and sea bottom, resulting in a reduction of 3 dB in sound level for each doubling of distance from the source (10*log[range]).

    Underwater Sound—The intensity of pile driving and removal sounds is greatly influenced by factors such as the type of piles, hammers, and the physical environment in which the activity takes place. A number of studies, primarily on the west coast, have measured sound produced during underwater pile driving projects. These data are largely for impact driving of steel pipe piles and concrete piles as well as vibratory driving of steel pipe piles.

    JASCO Applied Sciences (JASCO) conducted acoustic modeling of pile installation and removal activities planned for the Project, which is included as Appendix A of the FAA's application. To assess potential underwater noise exposure of marine mammals during construction activities, Quijano and Austin (2017) determined source levels for six different construction scenarios (see Table 1). The source levels are frequency-dependent and suitable for modeling underwater acoustic propagation using JASCO's Marine Operations Noise Model (MONM). The modeling predicted the extent of ensonification and the acoustic footprint from construction activities, taking into account the effects of pile driving equipment, bathymetry, sound speed profile, and seabed geoacoustic parameters. Auditory weighting was applied to the modeled sound fields to estimate received levels relative to hearing sensitivities of five marine mammal hearing groups following NMFS 2016 guidance.

    The results are based on currently adopted sound level thresholds for auditory injury (Level A) expressed as peak pressure level (PK) and 24-hr SEL, and behavioral disturbance (Level B) expressed as sound pressure level (SPL). Using these guidelines, Quijano and Austin (2017) calculated the maximum extent (distance and ensonified areas) of the Level A and Level B exposure zones for each marine mammal functional hearing group. This was calculated for both impact and vibratory pile driving of 18- and 30-inch (in) piles for each of the following six Project scenarios.

    The model required, as input, source sound levels in 1/3-octave bands between 10 hertz (Hz) and 25 kilohertz (kHz). Source levels for sheet pile and H pile installation were obtained from literature, but the available measurements did not cover the full frequency spectrum of interest; data for vibratory installation of sheet and H piles were available to maximum frequencies of 4 kHz and 10 kHz, respectively. Modeling of the six construction scenarios at the Project site on Biorka Island followed three steps:

    1. Piles driven into the sediment by impact, vibratory, or downhole drilling were characterized as sound-radiating sources. Source levels in 1/3-octave-bands were obtained by modeling or by adjusting source levels found in the literature. The exact method to obtain the 1/3-octave-band levels depends on the pile geometry and pile driving equipment, and it is described on a case-by-case basis (see Appendix A of the FAA's application);

    2. Underwater sound propagation was applied to predict how sound propagates from the pile into the water column as a function of range, depth, and azimuthal direction. Propagation depends on several conditions including the frequency content of the sound, the bathymetry, the sound speed in the water column, and sediment geoacoustics; and

    3. The propagated sound field was used to compute received levels over a grid of simulated receivers, from which distances to criteria thresholds and maps of ensonified areas were generated.

    Modeled results are presented as tables of distances at which SPLs or SELs fell below thresholds defined by criteria. For marine mammal injury, the Level A thresholds considered here follow the NMFS guidelines (NMFS 2016). A detailed description of the modeling process is provided in Appendix A of the FAA's IHA application. A list of modeling parameters, including pile driving duration for computation of SEL, are provided in Table 1.

    BILLING CODE 3510-22-P EN31OC17.000 BILLING CODE 3510-22-C Marine Mammal Occurrence

    In this section we provide the information about the presence, density, or group dynamics of marine mammals that will inform the take calculations.

    At-sea densities for marine mammal species have not been determined for marine mammals in Sitka Sound; therefore, all estimates here are determined by using observational data from biologists, peer-reviewed literature, and information obtained from personal communication with researchers and state and Federal biologists, and from local charter boat operators.

    Harbor Seals

    Harbor seals are expected to be in the Project area in low numbers (see Description of Marine Mammals in the Area of the Specified Activity Section). We estimate that up to five harbor seals per day may be present in the Project area on all days of construction. Therefore, we authorize 350 takes by Level B harassment. Because the largest Level A ZOI for harbor seals is nearly 1 kilometer (km) (Scenario 6), the FAA requests up to 13 harbor seal takes by Level A harassment. Level A harassment may occur if the animals enter the ZOI undetected on half of all days of construction in Scenario 6 and one time for each of the other five scenarios, and marine mammal observers (MMO) are not able to request a shutdown prior to the seals being exposed to potential Level A harassment.

    Steller Sea Lion

    Steller sea lion abundance in the Project area is dependent on prey availability. Prey species are uncommon during the Project window; therefore, sea lion abundance is expected to be low. The FAA estimates that five sea lions may be in the Project area every day (70 days) of construction, therefore, we estimate that 350 sea lions may be taken by Level B harassment. We estimate that these takes would be split equally between the east distinct population segment (DPS) and west DPS (175 each). The Level A zone is less than 10 m for all but Scenario 6, which is 80 m; however, to be conservative, the FAA is requesting a small group of Steller sea lions may be taken by Level A harassment. This would equate to six total animals if split equally by DPS (3 each).

    Humpback Whale

    Humpback whales are found in Sitka Bay seasonally. During mid-summer, tour boats generally see four to five whales per day, in the middle of Sitka Sound. Therefore, a count of 5 humpback whales per day (70 days) was used to estimate takes per day on every day of construction for a total of 350 takes by Level B harassment. All takes would be from the Central North Pacific stock under the MMPA. For ESA purposes, 93.9 percent would be from the Hawaii DPS (328 animals) and 6.1 percent would be from the Mexico stock (22 animals) based on Wade et al., 2016. The maximum distance at which a humpback whale may be exposed to noise levels that exceed Level A thresholds is 1.4 km during Scenario 6. Even though the ensonified area extends outside of the entrance to Symonds Bay, a MMO stationed near the mouth of the bay at Hanus Point would be able to see a humpback whale outside Symonds Bay before it enters the Level A zone and could shut down the noise producing activity to avoid Level A take. In the unlikely event a whale would go undetected and enter the Level A zone, the FAA has requested three takes by Level A harassment for humpback whales. We estimate that all three humpback whales would be from the Hawaii DPS.

    Killer Whale

    Generally, transient killer whales follow the movements of Steller sea lions and harbor seals on which they prey. Given the low numbers of Steller sea lions in Sitka Sound during summer, it is consistent that transient killer whales would also be rare or infrequent in the Project area (e.g., killer whales were only observed on five or six days by the whale watching industry). Small groups of 5 to 6 transient killer whales per day could be observed throughout the summer months; therefore, we estimate that a group of 6 animals could enter the Project area on 6 occasions during the construction window, for a total of 36 takes by Level B harassment. No Level A takes of killer whales is authorized for this species. The maximum linear distance to the Level A threshold for killer whales is less than 250 meters (m) from the source and a MMO would be able to observe animals at this distance and shut down activities in time to avoid Level A take.

    Harbor Porpoise

    Harbor porpoise are expected to occur in the Project area in low numbers during the construction window. Sightings during this time period are infrequent; this species is not observed every day. The mean group size of harbor porpoise in Southeast Alaska was estimated to be between 2 to 3 individuals (Dahlheim et al., 2009); therefore, we conservatively estimate that a group of three harbor porpoise may be present every other day of construction for a total of 105 takes by Level B harassment. The distances to Level A thresholds for harbor porpoise (HFC) are largest during impulse driving under Scenarios 3, 5, and 6 (see Table 1), and extend beyond the entrance to Symonds Bay. The duration of Scenarios 3, 5, and 6 is expected to be 30 days (see Table 1); therefore, we expect that a small group of three harbor porpoise may enter the Level A zone on half of the days of Scenarios 3, 5, and 6 (15 days) for a total of 45 takes by Level A harassment.

    Take Calculation and Estimation

    Here we describe how the information provided above is brought together to produce a quantitative take estimate.

    All estimates are conservative and include the following assumptions:

    • All pilings installed at each site would have an underwater noise disturbance equal to the piling that causes the greatest noise disturbance (i.e., the piling farthest from shore) installed with the method that has the ZOI. The largest underwater disturbance (Level B) ZOI would be produced by DTH drilling; therefore take estimates were calculated using the vibratory pile-driving ZOIs. The ZOIs for each threshold are not spherical and are truncated by land masses on either side of the Project area, which would dissipate sound pressure waves.

    • Exposures were based on an estimated total of 70 work days. Each activity ranges in number of days needed to be completed (Table 1).

    • All marine mammal individuals potentially available are assumed to be present within the relevant area, and thus incidentally taken;

    • An individual can only be taken once during a 24-hour period; and,

    • Exposures to sound levels at or above the relevant thresholds equate to take, as defined by the MMPA.

    Estimates of potential instances of take may be overestimates of the number of individuals taken. In the context of stationary activities such as pile driving and in areas where resident animals may be present, this number represents the number of total take that may accrue to a smaller number of individuals, with some number of animals being exposed more than once per individual. While pile driving and removal can occur any day throughout the in-water work window, and the analysis is conducted on a per day basis, only a fraction of that time (typically a matter of hours on any given day) is actually spent pile driving/removal. The potential effectiveness of mitigation measures in reducing the number of takes is typically not quantified in the take estimation process. For these reasons, these take estimates may be conservative.

    Table 5—Calculations for Incidental Take Estimation Species Takes
  • authorized
  • by Level A
  • harassment
  • Takes
  • authorized
  • by Level B
  • harassment
  • Steller sea lion: Eastern and Western stock 6 350 Harbor seal 13 350 Humpback whale 3 350 Killer whale: Eastern North Pacific Gulf of Alaska, Aleutian Island, and Bering Sea Transient stock and West Coast Transient stock 0 36 Harbor porpoise 45 105
    Mitigation Measures

    In order to issue an IHA under section 101(a)(5)(D) of the MMPA, NMFS must set forth the permissible methods of taking pursuant to such activity, and other means of effecting the least practicable impact on such species or stock and its habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of such species or stock for taking for certain subsistence uses (latter not applicable for this action). NMFS regulations require applicants for incidental take authorizations to include information about the availability and feasibility (economic and technological) of equipment, methods, and manner of conducting such activity or other means of effecting the least practicable adverse impact upon the affected species or stocks and their habitat (50 CFR 216.104(a)(11)).

    In evaluating how mitigation may or may not be appropriate to ensure the least practicable adverse impact on species or stocks and their habitat, as well as subsistence uses where applicable, we carefully balance two primary factors:

    (1) The manner in which, and the degree to which, the successful implementation of the measure(s) is expected to reduce impacts to marine mammals, marine mammal species or stocks, and their habitat—which considers the nature of the potential adverse impact being mitigated (likelihood, scope, range), as well as the likelihood that the measure will be effective if implemented; and the likelihood of effective implementation, and;

    (2) The practicability of the measures for applicant implementation, which may consider such things as cost, impact on operations, and, in the case of a military readiness activity, personnel safety, practicality of implementation, and impact on the effectiveness of the military readiness activity.

    The ZOIs were used to develop mitigation measures for pile driving and removal activities at the Project area. The ZOIs effectively represent the mitigation zone that would be established around each pile to prevent Level A harassment to marine mammals, while providing estimates of the areas within which Level B harassment might occur. In addition to the specific measures described later in this section, the FAA would conduct briefings between construction supervisors and crews, marine mammal monitoring team, and staff prior to the start of all pile driving activity, and when new personnel join the work, in order to explain responsibilities, communication procedures, marine mammal monitoring protocol, and operational procedures.

    Monitoring and Shutdown for Construction Activities

    The following measures would apply to the FAA's mitigation through shutdown and disturbance zones:

    Shutdown Zone—For all pile driving activities, the FAA will establish a shutdown zone intended to contain the area in which SPLs equal or exceed the auditory injury criteria for cetaceans and pinnipeds. The purpose of a shutdown zone is to define an area within which shutdown of activity would occur upon sighting of a marine mammal (or in anticipation of an animal entering the defined area), thus preventing injury of marine mammals (as described previously under Potential Effects of the Specified Activity on Marine Mammals, serious injury or death are unlikely outcomes even in the absence of mitigation measures). Modeled radial distances for shutdown zones are shown in Table 6. However, a minimum shutdown zone of 10 m will be established during all pile driving activities, regardless of the estimated zone; and

    Disturbance Zone—Disturbance zones are the areas in which SPLs equal or exceed 160 and 120 dB rms (for impulse and continuous sound, respectively). Disturbance zones provide utility for monitoring conducted for mitigation purposes (i.e., shutdown zone monitoring) by establishing monitoring protocols for areas adjacent to the shutdown zones. Monitoring of disturbance zones enables observers to be aware of and communicate the presence of marine mammals in the Project area but outside the shutdown zone and thus prepare for potential shutdowns of activity. However, the primary purpose of disturbance zone monitoring is for documenting instances of Level B harassment; disturbance zone monitoring is discussed in greater detail later (see Monitoring and Reporting Measures). Nominal radial distances for disturbance zones are shown in Table 6.

    Given the size of the disturbance zone for vibratory pile driving and DTH drilling, it is impossible to guarantee that all animals would be observed or to make comprehensive observations of fine-scale behavioral reactions to sound, and only a portion of the zone (e.g., what may be reasonably observed by visual observers stationed between Symonds Bay and Sitka Sound) would be observed. In order to document observed instances of harassment, monitors record all marine mammal observations, regardless of location. The observer's location, as well as the location of the pile being driven, is known from a GPS. The location of the animal is estimated as a distance from the observer, which is then compared to the location from the pile. It may then be estimated whether the animal was exposed to sound levels constituting incidental harassment on the basis of predicted distances to relevant thresholds in post-processing of observational and acoustic data, and a precise accounting of observed incidences of harassment created. This information may then be used to extrapolate observed takes to reach an approximate understanding of actual total takes.

    BILLING CODE 3510-22-P EN31OC17.001 BILLING CODE 3510-22-C

    Monitoring Protocols—Monitoring would be conducted before, during, and after pile driving and vibratory removal activities. In addition, observers shall record all instances of marine mammal occurrence, regardless of distance from activity, and shall document any behavioral reactions in concert with distance from piles being driven. Observations made outside the shutdown zone will not result in shutdown; that pile segment would be completed without cessation, unless the animal approaches or enters the shutdown zone, at which point all pile driving activities would be halted. Monitoring will take place from 30 minutes prior to initiation through 30 minutes post-completion of pile driving and removal activities. Pile driving activities include the time to install or remove a single pile or series of piles, as long as the time elapsed between uses of the pile driving equipment is no more than 30 minutes. Please see Section 11 of the FAA's application (www.nmfs.noaa.gov/pr/permits/incidental/construction.htm), for the FAA's monitoring protocols.

    The following additional measures apply to visual monitoring:

    (1) Monitoring will be conducted by qualified observers, who will be placed at the best vantage point(s) practicable to monitor for marine mammals and implement shutdown/delay procedures when applicable by calling for the shutdown to the hammer operator. A minimum of two observers will be required for all pile driving/removal activities. MMO requirements for construction actions are as follows:

    (a) Independent observers (i.e., not construction personnel) are required;

    (b) At least one observer must have prior experience working as an observer;

    (c) Other observers (that do not have prior experience) may substitute education (undergraduate degree in biological science or related field) or training for experience;

    (d) Where a team of three or more observers are required, one observer should be designated as lead observer or monitoring coordinator. The lead observer must have prior experience working as an observer; and

    (e) NMFS will require submission and approval of observer resumes.

    (2) Qualified MMOs are trained biologists, and need the following additional minimum qualifications:

    (a) Visual acuity in both eyes (correction is permissible) sufficient for discernment of moving targets at the water's surface with ability to estimate target size and distance; use of binoculars may be necessary to correctly identify the target;

    (b) Ability to conduct field observations and collect data according to assigned protocols;

    (c) Experience or training in the field identification of marine mammals, including the identification of behaviors;

    (d) Sufficient training, orientation, or experience with the construction operation to provide for personal safety during observations;

    (e) Writing skills sufficient to prepare a report of observations including but not limited to the number and species of marine mammals observed; dates and times when in-water construction activities were conducted; dates and times when in-water construction activities were suspended to avoid potential incidental injury from construction sound of marine mammals observed within a defined shutdown zone; and marine mammal behavior; and

    (f) Ability to communicate orally, by radio or in person, with project personnel to provide real-time information on marine mammals observed in the area as necessary.

    (3) Prior to the start of pile driving activity, the shutdown zone will be monitored for 30 minutes to ensure that it is clear of marine mammals. Pile driving will only commence once observers have declared the shutdown zone clear of marine mammals; animals will be allowed to remain in the shutdown zone (i.e., must leave of their own volition) and their behavior will be monitored and documented. The shutdown zone may only be declared clear, and pile driving started, when the entire shutdown zone is visible (i.e., when not obscured by dark, rain, fog, etc.). In addition, if such conditions should arise during impact pile driving that is already underway, the activity would be halted.

    (4) If a marine mammal approaches or enters the shutdown zone during the course of pile driving operations, activity will be halted and delayed until either (A) the animal has voluntarily left and been visually confirmed beyond the shutdown zone, (B) 15 minutes have passed without re-detection of small cetaceans and pinnipeds, or (C) 30 minutes have passed without re-detection of large cetaceans, whichever happens sooner. Monitoring will be conducted throughout the time required to drive a pile.

    (5) If a species for which authorization has not been granted, or a species for which authorization has been granted but the authorized takes are met, approaches or is observed within the Level B harassment zone, activities will shut down immediately using delay and shut-down procedures. Activities will not restart until the animals have been confirmed to have left the area.

    Soft Start

    The use of a soft start procedure is believed to provide additional protection to marine mammals by warning or providing a chance to leave the area prior to the hammer operating at full capacity, and typically involves a requirement to initiate sound from the hammer at reduced energy followed by a waiting period. This procedure is repeated two additional times. It is difficult to specify the reduction in energy for any given hammer because of variation across drivers and, for impact hammers, the actual number of strikes at reduced energy will vary because operating the hammer at less than full power results in “bouncing” of the hammer as it strikes the pile, resulting in multiple “strikes.” For impact driving, we require an initial set of three strikes from the impact hammer at reduced energy, followed by a 30-second waiting period, then 2 subsequent 3 strike sets. Soft start will be required at the beginning of each day's impact pile driving work and at any time following a cessation of impact pile driving of 30 minutes or longer.

    Noise Attenuating Devices

    The FAA will use cushions during impact pile driving.

    Timing Restrictions

    The FAA will only conduct construction activities during daytime hours. Construction will also be restricted to the months of May through September to avoid overlap with times when marine mammals have higher densities in the Project area.

    We have carefully evaluated the FAA's mitigation measures and considered their effectiveness in past implementation to determine whether they are likely to effect the least practicable impact on the affected marine mammal species and stocks and their habitat.

    Any mitigation measure(s) we prescribe should be able to accomplish, have a reasonable likelihood of accomplishing (based on current science), or contribute to the accomplishment of one or more of the general goals listed below:

    (1) Avoidance or minimization of injury or death of marine mammals wherever possible (goals 2, 3, and 4 may contribute to this goal);

    (2) A reduction in the number (total number or number at biologically important time or location) of individual marine mammals exposed to stimuli expected to result in incidental take (this goal may contribute to 1, above, or to reducing takes by behavioral harassment only);

    (3) A reduction in the number (total number or number at biologically important time or location) of times any individual marine mammal would be exposed to stimuli expected to result in incidental take (this goal may contribute to 1, above, or to reducing takes by behavioral harassment only);

    (4) A reduction in the intensity of exposure to stimuli expected to result in incidental take (this goal may contribute to 1, above, or to reducing the severity of behavioral harassment only);

    (5) Avoidance or minimization of adverse effects to marine mammal habitat, paying particular attention to the prey base, blockage or limitation of passage to or from biologically important areas, permanent destruction of habitat, or temporary disturbance of habitat during a biologically important time; and

    (6) For monitoring directly related to mitigation, an increase in the probability of detecting marine mammals, thus allowing for more effective implementation of the mitigation.

    Based on our evaluation of the FAA's measures, as well as any other potential measures considered by NMFS, NMFS has determined that the mitigation measures provide the means of effecting the least practicable impact on marine mammal species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance.

    Monitoring and Reporting Measures

    In order to issue an IHA for an activity, section 101(a)(5)(D) of the MMPA states that NMFS must set forth requirements pertaining to the monitoring and reporting of such taking. The MMPA implementing regulations at 50 CFR 216.104 (a)(13) indicate that requests for authorizations must include the suggested means of accomplishing the necessary monitoring and reporting that will result in increased knowledge of the species and of the level of taking or impacts on populations of marine mammals that are expected to be present in the action area. Effective reporting is critical to both compliance and ensuring that the most value is obtained from the required monitoring.

    Monitoring and reporting requirements prescribed by NMFS should contribute to improved understanding of one or more of the following:

    • Occurrence of marine mammal species in action area (e.g., presence, abundance, distribution, density);

    • Nature, scope, or context of likely marine mammal exposure to potential stressors/impacts (individual or cumulative, acute or chronic), through better understanding of: (1) Action or environment (e.g., source characterization, propagation, ambient noise); (2) affected species (e.g., life history, dive patterns); (3) co-occurrence of marine mammal species with the action; or (4) biological or behavioral context of exposure (e.g., age, calving or feeding areas);

    • Individual marine mammal responses (behavioral or physiological) to acoustic stressors (acute, chronic, or cumulative), other stressors, or cumulative impacts from multiple stressors;

    • How anticipated responses to stressors impact either: (1) Long-term fitness and survival of individual marine mammals; or (2) population, species, or stock;

    • Effects on marine mammal habitat (e.g., marine mammal prey species, acoustic habitat, or other important physical components of marine mammal habitat); and

    • Mitigation and monitoring effectiveness.

    Visual Marine Mammal Observations

    The FAA will collect sighting data and behavioral responses to construction for marine mammal species observed in the region of activity during the period of activity. All MMOs will be trained in marine mammal identification and behaviors and are required to have no other construction-related tasks while conducting monitoring. A minimum of two MMOs will be required for all pile driving/removal activities. The FAA will monitor the shutdown zone and disturbance zone before, during, and after pile driving, with observers located at the best practicable vantage points. Based on our requirements, the FAA would implement the following procedures for pile driving and removal:

    • MMOs would be located at the best vantage point(s) in order to properly see the entire shutdown zone and as much of the disturbance zone as possible;

    • During all observation periods, observers will use binoculars and the naked eye to search continuously for marine mammals;

    • If the shutdown zones are obscured by fog or poor lighting conditions, pile driving at that location will not be initiated until that zone is visible. Should such conditions arise while driving, removal, or drilling is underway, the activity would be halted; and

    • The shutdown and disturbance zones around the pile will be monitored for the presence of marine mammals before, during, and after any pile driving or removal activity.

    Data Collection

    We require that observers use approved data forms. Among other pieces of information, the FAA will record detailed information about any implementation of shutdowns, including the distance of animals to the pile and description of specific actions that ensued and resulting behavior of the animal, if any. In addition, the FAA will attempt to distinguish between the number of individual animals taken and the number of incidences of take. We require that, at a minimum, the following information be collected on the sighting forms:

    • Date and time that monitored activity begins or ends;

    • Construction activities occurring during each observation period;

    • Weather parameters (e.g., percent cover, visibility);

    • Water conditions (e.g., sea state, tide state);

    • Species, numbers, and, if possible, sex and age class of marine mammals;

    • Description of any observable marine mammal behavior patterns, including bearing and direction of travel, and if possible, the correlation to SPLs;

    • Distance from pile driving or removal activities to marine mammals and distance from the marine mammals to the observation point;

    • Description of implementation of mitigation measures (e.g., shutdown or delay);

    • Locations of all marine mammal observations; and

    • Other human activity in the area.

    Sound Source Verification

    The SSV will establish source levels for impact pile driving, vibratory pile driving, and DTH drilling. The FAA will provide all monitoring data to NMFS. The reports would include the following information:

    1. Size and type of piles;

    2. A detailed description of the noise attenuation device, including design specifications;

    3. The impact hammer energy rating used to drive the piles, and the make and model of the hammer and the output energy;

    4. The physical characteristics of the bottom substrate into which the piles were driven;

    5. The depth of water into which the pile was driven;

    6. The depth into the substrate into which the pile was driven;

    7. A description of the sound monitoring equipment;

    8. The distance between hydrophones and pile;

    9. The depth of the hydrophones and depth of water at hydrophone locations;

    10. The distance from the pile to the water's edge;

    11. The total number of strikes to drive each pile and for all piles driven during a 24-hour period;

    12. The results of the hydroacoustic monitoring;

    13. Source levels for peak and RMS SPLs and single strike SEL at 10 m from the pile, and RMS pulse duration that contains 90 percent of pulse energy.

    14. The distance at which peak, cumulative SEL, and RMS values exceed the respective threshold values;

    15. For vibratory pile driving, SEL based on 30 second averaging of sound intensity;

    16. The spectragraphs for each pile type; and

    17. A description of any observable marine mammal behavior in the immediate area and, if possible, correlation to underwater sound levels occurring at that time.

    A minimum of two piles of the 18-in and two piles of the 30-in piles for each construction type (i.e. impact and vibratory pile driving and DTH drilling) will be monitored. Piles chosen to be monitored will be representative of the different sizes and range of typical water depths at the project location where piles will be driven with an impact or vibratory hammer.

    One bottom-mounted hydrophone will be placed at the nearest distance, approximately 10 meters, from each pile being monitored. An additional hydrophone will be placed at mid-water depth at a distance of 100 to 200 m from the pile to provide two sound-level readings during ambient and pile driving conditions. A third hydrophone may be deployed at a greater distance (e.g., 1-2 km or further) for the purpose of better defining the long-distance sound propagation. Underwater sound levels will be continuously monitored during the entire duration of each pile being driven. Sound levels will be measured in dB re: 1 μPa.

    Reporting

    A draft report will be submitted to NMFS within 90 days of the completion of marine mammal monitoring, or 60 days prior to the requested date of issuance of any future IHA for projects at the same location, whichever comes first. The report will include marine mammal observations pre-activity, during-activity, and post-activity during pile driving and removal days, and will also provide descriptions of any behavioral responses to construction activities by marine mammals and a complete description of all mitigation shutdowns and the results of those actions and an extrapolated total take estimate based on the number of marine mammals observed during the course of construction. A final report must be submitted within 30 days following resolution of comments on the draft report.

    Negligible Impact Analysis and Determinations

    NMFS has defined negligible impact as an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival (50 CFR 216.103). A negligible impact finding is based on the lack of likely adverse effects on annual rates of recruitment or survival (i.e., population-level effects). An estimate of the number of takes alone is not enough information on which to base an impact determination. In addition to considering estimates of the number of marine mammals that might be “taken” through harassment, NMFS considers other factors, such as the likely nature of any responses (e.g., intensity, duration), the context of any responses (e.g., critical reproductive time or location, migration), as well as effects on habitat, and the likely effectiveness of the mitigation. We also assess the number, intensity, and context of estimated takes by evaluating this information relative to population status. Consistent with the 1989 preamble for NMFS's implementing regulations (54 FR 40338; September 29, 1989), the impacts from other past and ongoing anthropogenic activities are incorporated into this analysis via their impacts on the environmental baseline (e.g., as reflected in the regulatory status of the species, population size and growth rate where known, ongoing sources of human-caused mortality, or ambient noise levels). To avoid repetition, because the expected impacts to marine mammals of the affected species and stocks are similar (and we have no information to suggest otherwise), our discussion here applies to each of them.

    Pile driving and removal activities associated with the dock replacement Project, as outlined previously, have the potential to disturb or displace marine mammals. Specifically, the specified activities may result in take, in the form of Level A and Level B harassment (PTS and behavioral disturbance), from underwater sounds generated from pile driving and removal. Potential takes could occur if individuals of these species are present in the ensonified zone when pile driving and removal occurs. Most of the Level A takes are precautionary as marine mammals are not expected to enter and stay in the Level A ensonified area for the duration needed to incur PTS. However, if all authorized takes be Level A harassment were to occur, they would be of small numbers compared to the stock sizes and would not adversely affect the stock through effects on annual rates of recruitment or survival. Additionally, the FAA's mitigation measures, including a shutdown of construction activities if animals enter the Level A zone, further reduces the chance for PTS in marine mammals. Therefore, the effects to marine mammals are expected to be negligible.

    No temporary threshold shift (TTS), serious injury, or mortality is anticipated given the nature of the activities and measures designed to minimize the possibility of injury to marine mammals. The potential for these outcomes is minimized through the construction method and the implementation of the planned mitigation measures. Specifically, vibratory and impact hammers and drilling will be the primary methods of installation. Impact pile driving produces short, sharp pulses with higher peak levels and much sharper rise time to reach those peaks. If impact driving is necessary, implementation of soft start and shutdown zones significantly reduces any possibility of injury. Given sufficient “notice” through use of soft start (for impact driving), marine mammals are expected to move away from a sound source that is annoying prior to it becoming potentially injurious, however, as noted previously a small number of potential takes by PTS are authorized and have been analyzed. The FAA will use a minimum of two MMOs stationed strategically to increase detectability of marine mammals, enabling a high rate of success in implementation of shutdowns to avoid injury.

    The FAA's Project activities are localized and of relatively short duration (a maximum of 70 days for pile driving and removal). The entire Project area is limited to Symonds Bay and into Sitka Sound for some scenarios. These localized and short-term noise exposures may cause short-term behavioral modifications in harbor seals, Steller sea lions, harbor porpoises, killer whales, and humpback whales. Moreover, the mitigation and monitoring measures are expected to reduce the likelihood of injury. Additionally, no important feeding and/or reproductive areas for marine mammals of any of these species/stocks are known to be within the ensonified area during the construction window.

    Effects on individuals that are taken by Level B harassment, on the basis of reports in the literature as well as monitoring from other similar activities, will likely be limited to reactions such as increased swimming speeds, increased surfacing time, or decreased foraging (if such activity were occurring) (e.g., Thorson and Reyff 2006; Lerma 2014). Significant behavioral modifications that could potentially lead to effects on growth, survival, or reproduction are not expected to occur given the short duration and small scale of the project activities. Most likely, individuals will simply move away from the sound source and be temporarily displaced from the areas of pile driving and drilling, although even this reaction has been observed primarily only in association with impact pile driving. Thus, even repeated Level B harassment of some small subset of the overall stock is unlikely to result in any significant realized decrease in fitness for the affected individuals, and thus would not result in any adverse impact to the stock as a whole. Non-auditory physiological effects and masking are not expected to occur from the FAA's Project activities.

    The Project also is not expected to have significant adverse effects on affected marine mammals' habitat. The Project activities would not modify existing marine mammal habitat for a significant amount of time. The activities may cause some fish to leave the area of disturbance, thus temporarily impacting marine mammals' foraging opportunities in a limited portion of the foraging range. However, because of the short duration of the activities and the relatively small area of the habitat that may be affected, and the decreased potential of prey species to be in the Project area during the construction work window, the impacts to marine mammal habitat are not expected to cause significant or long-term negative consequences.

    In summary and as described above, the following factors primarily support our determination that the impacts resulting from this activity are not expected to adversely affect the species or stocks through effects on annual rates of recruitment or survival:

    • No mortality or serious injury is anticipated or authorized;

    • Level B harassment may consist of, at worst, temporary modifications in behavior (e.g. temporary avoidance of habitat or changes in behavior);

    • The lack of important feeding, pupping, or other areas in the action area during the construction window;

    • Mitigation is expected to minimize the likelihood and severity of the level of harassment; and

    • The small percentage of the species/stock that may be affected by Project activities (<15 percent for all species/stocks).

    Based on the analysis contained herein of the likely effects of the specified activity on marine mammals and their habitat, and taking into consideration the implementation of the monitoring and mitigation measures, NMFS finds that the total marine mammal take from the FAA's construction activities will have a negligible impact on the affected marine mammal species or stocks.

    Small Numbers

    As noted above, only small numbers of incidental take may be authorized under Section 101(a)(5)(D) of the MMPA for specified activities other than military readiness activities. The MMPA does not define small numbers and so, in practice, where estimated numbers are available, NMFS compares the number of individuals taken to the most appropriate estimation of abundance of the relevant species or stock in our determination of whether an authorization is limited to small numbers of marine mammals. Additionally, other qualitative factors may be considered in the analysis, such as the temporal or spatial scale of the activities.

    Table 7 details the number of instances that animals could be exposed to received noise levels that could cause Level A and Level B harassment for the planned work at the Project site relative to the total stock abundance. The numbers of animals authorized to be taken for each species or stock is considered small relative to the relevant species or stock size even if each estimated instance of take occurred to a new individual. The total percent of the population (if each instance was a separate individual) for which take is requested is less than 15 percent for each stock (Table 7). For pinnipeds, especially harbor seals occurring in the vicinity of the Project area, there will almost certainly be some overlap in individuals present day-to-day, and the number of individuals taken is expected to be notably lower.

    Based on the analysis contained herein of the Project activities (including the mitigation and monitoring measures) and the anticipated take of marine mammals, NMFS finds that small numbers of marine mammals will be taken relative to the population size of the affected species or stocks.

    Table 7—Estimated Numbers and Percentage of Stock That May Be Exposed to Level A and Level B Harassment Species Authorized Level A takes Authorized Level B takes Stock(s)
  • abundance
  • estimate 1
  • Percentage of total stock
  • (percent)
  • Harbor Seal (Phoca vitulina): Sitka/Chatham stock 13 350 14,855 2.44 Steller sea lion (Eumatopias jubatus): Western U.S. Stock 6 350 50,983 0.698 Eastern U.S. Stock 41,638 0.855 Killer whale (Orcinus orca): Eastern North Pacific, Gulf of AK, Aleutian Island, and Bering Sea Transient Stock 0 36 587 6.13 West Coast Transient Stock 243 14.8 Humpback whale (Megaptera noviaengliae): Central North Pacific Stock 3 350 10,103 3.49 Harbor Porpoise (Phocoena phocoena): Southeast Alaska Stock 45 105 11,146 1.34 1 All stock abundance estimates presented here are from the 2016 Alaska Stock Assessment Report.
    Unmitigable Adverse Impact Analysis and Determination

    In order to issue an IHA, NMFS must find that the specified activity will not have an “unmitigable adverse impact” on the subsistence uses of the affected marine mammal species or stocks by Alaskan Natives. NMFS has defined “unmitigable adverse impact” in 50 CFR 216.103 as: an impact resulting from the specified activity: (1) That is likely to reduce the availability of the species to a level insufficient for a harvest to meet subsistence needs by: (i) Causing the marine mammals to abandon or avoid hunting areas; (ii) Directly displacing subsistence users; or (iii) Placing physical barriers between the marine mammals and the subsistence hunters; and (2) That cannot be sufficiently mitigated by other measures to increase the availability of marine mammals to allow subsistence needs to be met.

    Harbor seals and Steller sea lions are subsistence harvested in Alaska. During 2012, the estimated subsistence take of harbor seals in southeast Alaska was 595 seals with 49 of these taken near Sitka (Wolfe et al., 2013). This is the lowest number of seals taken since 1992 (Wolfe et al., 2013) and is attributed to the decline in subsistence hunting pressure over the years as well as a decrease in efficiency per hunter (Wolf et al., 2013).

    The peak hunting season in southeast Alaska occurs during the month of November and again over the March to April time frame (Wolfe et al., 2013). This corresponds to times when seals are aggregated in shoal areas as they prey on forage species such as herring, making them easier to find and hunt.

    The Project is in an area where subsistence hunting for harbor seals or sea lions could occur (Wolfe et al., 2013), but the location is not preferred for hunting. There is little to no hunting documented in the vicinity and there are no harvest quotas for non-listed marine mammals. For these reasons and the fact that Project activities would occur outside of the primary subsistence hunting seasons, there would be no impact on subsistence activities or on the availability of marine mammals for subsistence use.

    To satisfy requirements under Section 106 of the National Historic Preservation Act, R&M Consultants, Inc. reached out to the Sitka Tribe of Alaska, Central Council of the Tlingit and Haida, and Sealaska regarding cultural resources in 2016. No issues or concerns with the Project were raised during this effort.

    Based on the description of the specified activity, the measures described to minimize adverse effects on the availability of marine mammals for subsistence purposes, and the mitigation and monitoring measures, NMFS has determined that there will not be an unmitigable adverse impact on subsistence uses from the FAA's activities.

    Endangered Species Act

    Section 7(a)(2) of the Endangered Species Act of 1973 (ESA: 16 U.S.C. 1531 et seq.) requires that each Federal agency insure that any action it authorizes, funds, or carries out is not likely to jeopardize the continued existence of any endangered or threatened species or result in the destruction or adverse modification of designated critical habitat. To ensure ESA compliance for the issuance of IHAs, NMFS consults internally, in this case with the Alaska Regional Office, whenever we propose to authorize take for endangered or threatened species.

    NMFS is authorizing take of two DPSs (i.e., western DPS of Steller sea lions and Mexico DPS of humpback whales), which are listed under the ESA. The Permit and Conservation Division requested initiation of Section 7 consultation with the Alaska Region for the issuance of this IHA. The NMFS Alaska Regional Office Protected Resources Division issued a Biological Opinion in October, 2017 under section 7 of the ESA, on the issuance of an IHA to the FAA under section 101(a)(5)(D) of the MMPA by the NMFS Permits and Conservation Division. The Biological Opinion concluded that the proposed action is not likely to jeopardize the continued existence of western DPS Steller sea lions or Mexico DPS of humpback whales, and is not likely to destroy or adversely modify western DPS Steller sea lion critical habitat.

    Authorization

    NMFS has issued an IHA to the FAA for the potential harassment of small numbers of five marine mammal species incidental to the Biorka Island dock replacement project in Sitka, AK, provided the previously mentioned mitigation, monitoring and reporting requirements are incorporated.

    Dated: October 25, 2017. Donna S. Wieting, Director, Office of Protected Resources, National Marine Fisheries Service.
    [FR Doc. 2017-23563 Filed 10-30-17; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XF803 Western Pacific Fishery Management Council; Public Meetings AGENCY:

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

    ACTION:

    Notice of public meetings.

    SUMMARY:

    The Western Pacific Fishery Management Council (Council) will hold its 172nd meeting by teleconference and webinar to discuss and make recommendations on fishery management issues in the Western Pacific Region.

    DATES:

    The Council will meet on November 15, 2017, between 2 p.m. and 5 p.m. (Hawaii Standard Time (HST)); 1 and 4 p.m. (American Samoa Standard Time (ASST)); and November 16, 2017, between 10 a.m. and 1 p.m. (Marianas Standard Time (MST)). All times listed are local island times. For specific time and agenda, see SUPPLEMENTARY INFORMATION.

    ADDRESSES:

    The meeting will be held by teleconference and webinar. The teleconference numbers are: U.S. toll-free: 1 (888) 482-3560, International Access: +1 (647) 723-3959, and Access Code: 5228220. The webinar can be accessed at: https://wprfmc.webex.com/join/info.wpcouncilnoaa.gov.

    The following venues will also be host sites for the teleconference: Council Conference Room, 1164 Bishop Street, Suite 1400, Honolulu, Hawaii; Land Grant Conference Room, American Samoa Community College, Agriculture, Community and Natural Resources, Mapusaga Road, Malaeimi Village, American Samoa; Guam Hilton Resort and SPA, 202 Hilton Road, Tumon Bay, Guam; Department of Land and Natural Resources Conference Room, Santa Remedio Drive, Lower Base, Saipan, MP.

    FOR FURTHER INFORMATION CONTACT:

    Kitty M. Simonds, Executive Director; telephone: (808) 522-8220.

    SUPPLEMENTARY INFORMATION:

    Public comment opportunity will be provided in the agenda. The order in which agenda items are addressed may change. The meeting will run as late as necessary to complete scheduled business. Written comments must be received by November 10, 2017. Background documents will be available from, and written comments should be sent to, Kitty M. Simonds, Executive Director; Western Pacific Fishery Management Council, 1164 Bishop Street, Suite 1400, Honolulu, HI 96813; phone: (808) 522-8220 or fax: (808) 522-8226.

    Schedule and Agenda for the 172nd Council Meeting 2 p.m.-5 p.m., Wednesday, November 15 (HST); 1 p.m.-4 p.m., Wednesday, November 15, 2016 (ASST); 10 a.m.-1 p.m., Thursday, November 16, 2016 (MST) 1. Welcome and Introductions 2. Review and Approval of the 172nd Agenda 3. Modifying the Swordfish Trip Limit in the American Samoa Longline Fishery (Final Action) 4. Public Hearing 5. Other Business 6. Council Discussion and Recommendations

    Non-Emergency issues not contained in this agenda may come before the Council for discussion and formal Council action during its 172nd meeting. However, Council action on regulatory issues will be restricted to those issues specifically listed in this document and any regulatory issue arising after publication of this document that requires emergency action under section 305(c) of the Magnuson-Stevens Act, provided the public has been notified of the Council's intent to take action to address the emergency.

    Agenda items noted as “Final Action Items” refer to actions that result in Council transmittal of a proposed fishery management plan, proposed plan amendment, or proposed regulations to the U.S. Secretary of Commerce, under Sections 304 or 305 of the Magnuson-Stevens Fishery Conservation and Management Act.

    Special Accommodations

    The host sites are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Kitty M. Simonds, (808) 522-8220 (voice) or (808) 522-8226 (fax), at least 5 days prior to the meeting date.

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: October 25, 2017. Tracey L. Thompson, Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2017-23600 Filed 10-30-17; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XF802 Mid-Atlantic Fishery Management Council (MAFMC); Public Meeting AGENCY:

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

    ACTION:

    Notice; public meeting.

    SUMMARY:

    The Mid-Atlantic Fishery Management Council's (MAFMC's) Summer Flounder, Scup, and Black Sea Bass Advisory Panel will hold a public meeting via webinar, jointly with the Atlantic States Marine Fisheries Commission's (ASMFC's) Summer Flounder, Scup, and Black Sea Bass Advisory Panel.

    DATES:

    The meeting will be held on Monday, November 20, 2017, from 2 p.m. to 5 p.m. See SUPPLEMENTARY INFORMATION for agenda details.

    ADDRESSES:

    The meeting will take place over webinar with a telephone-only connection option. Details on how to connect to the webinar by computer and by telephone will be available at: http://www.mafmc.org.

    Council address: Mid-Atlantic Fishery Management Council, 800 N. State Street, Suite 201, Dover, DE 19901; telephone: (302) 674-2331; Web site: www.mafmc.org.

    FOR FURTHER INFORMATION CONTACT:

    Christopher M. Moore, Ph.D., Executive Director, Mid-Atlantic Fishery Management Council, telephone: (302) 526-5255.

    SUPPLEMENTARY INFORMATION:

    The Mid-Atlantic Fishery Management Council's Summer Flounder, Scup, and Black Sea Bass Advisory Panel, together with the Atlantic States Marine Fisheries Commission's Advisory Panel, will meet on Monday, November 20, 2017. The purpose of this meeting is to review and provide feedback on proposed recreational management measures (e.g., bag limits, size limits, and seasons) and strategies for the recreational summer flounder, scup, and black sea bass fisheries in 2018.

    A detailed agenda and background documents will be made available on the Council's Web site (www.mafmc.org) prior to the meeting.

    Special Accommodations

    The meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aid should be directed to M. Jan Saunders, (302) 526-5251, at least 5 days prior to the meeting date.

    Dated: October 25, 2017. Tracey L. Thompson, Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2017-23591 Filed 10-30-17; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XF796 New England Fishery Management Council; Public Meeting AGENCY:

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

    ACTION:

    Notice; public meeting.

    SUMMARY:

    The New England Fishery Management Council (Council) is scheduling a public meeting of its Herring Committee to consider actions affecting New England fisheries in the exclusive economic zone (EEZ). Recommendations from this group will be brought to the full Council for formal consideration and action, if appropriate.

    DATES:

    This meeting will be held on Tuesday, November 21, 2017 at 8:30 a.m.

    ADDRESSES:

    The meeting will be held at the Holiday Inn, 700 Myles Standish Blvd., Taunton, MA 02780; telephone: (508) 823-0430.

    Council address: New England Fishery Management Council, 50 Water Street, Mill 2, Newburyport, MA 01950.

    FOR FURTHER INFORMATION CONTACT:

    Thomas A. Nies, Executive Director, New England Fishery Management Council; telephone: (978) 465-0492.

    SUPPLEMENTARY INFORMATION: Agenda

    The committee will review analyses prepared for Herring Amendment 8 Draft Environmental Impact Statement (DEIS) specific to the range of alternatives developed to address potential localized depletion and user conflicts in the herring fishery. The committee may identify preferred alternatives for the Council to consider. The committee is not scheduled to discuss the other measures under consideration in Amendment 8, Acceptable Biological Catch (ABC) control rule alternatives. The Council reviewed the ABC control rule alternatives at the September 2017 meeting and declined to select a preferred alternative, but approved that portion of Amendment 8 to proceed for submission and public comment. They will discuss recommendations for the Council to consider for Herring Research Set-Aside research priorities for fishing years 2019-21 and discuss any challenges the program has had in recent years. They will discuss other business, as necessary.

    Although non-emergency issues not contained in this agenda may come before this group for discussion, those issues may not be the subject of formal action during these meetings. Action will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Act, provided the public has been notified of the Council's intent to take final action to address the emergency.

    Special Accommodations

    This meeting is physically accessible to people with disabilities. This meeting will be recorded. Consistent with 16 U.S.C. 1852, a copy of the recording is available upon request. Requests for sign language interpretation or other auxiliary aids should be directed to Thomas A. Nies, Executive Director, at (978) 465-0492, at least 5 days prior to the meeting date.

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: October 25, 2017. Tracey L. Thompson, Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2017-23593 Filed 10-30-17; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF DEFENSE Department of the Army [Docket ID USA-2017-HQ-0005] Submission for OMB Review; Comment Request AGENCY:

    Department of the Army, 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 November 30, 2017.

    ADDRESSES:

    Comments and recommendations on the proposed information collection should be emailed to Mr. Vlad Dorjets, 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: Lock Performance Monitoring System (LPMS) Waterway Traffic Report; ENG FORM 3102C and 3102D; OMB Control Number 0710-0008.

    Type of Request: Reinstatement.

    Number of Respondents: 6529.

    Responses per Respondent: 73.

    Annual Responses: 474642.

    Average Burden per Response: 2.5 minutes.

    Annual Burden Hours: 20568.

    Needs and Uses: The U.S. Army Corps of Engineers utilizes the data collected to monitor and analyze the use and operation of federally owned or operated locks. General data of vessel identification, tonnage, and commodities are supplied by the master of vessels and all locks owned and operated by the U.S. Army Corps of Engineers. The information is used for sizing and scheduling replacements, the timing of rehabilitation or maintenance actions, and the setting of operation procedures and closures for locks and canals.

    Affected Public: Business or other for-profit.

    Frequency: On occasion.

    Respondent's Obligation: Voluntary.

    OMB Desk Officer: Mr. Vlad Dorjets.

    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: October 26, 2017. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense.
    [FR Doc. 2017-23623 Filed 10-30-17; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF DEFENSE Office of the Secretary Revised Non-Foreign Overseas per Diem Rates AGENCY:

    Defense Travel Management Office, DoD.

    ACTION:

    Notice of Revised Non-Foreign Overseas Per Diem Rates.

    SUMMARY:

    The Defense Travel Management Office is publishing Civilian Personnel Per Diem Bulletin Number 307. This bulletin lists revisions in the per diem rates prescribed for U.S. Government employees for official travel in Alaska, Hawaii, Puerto Rico, the Northern Mariana Islands and Possessions of the United States when applicable. AEA changes announced in Bulletin Number 194 remain in effect. Bulletin Number 307 is being published in the Federal Register to assure that travelers are paid per diem at the most current rates.

    DATES:

    The revised per diem rates go into effect November 1, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Ms. Sonia Malik, 571-372-1276.

    SUPPLEMENTARY INFORMATION:

    This document gives notice of revisions in per diem rates prescribed by the Defense Travel Management Office for non-foreign areas outside the contiguous United States. Per Diem Bulletins published periodically in the Federal Register now constitute the only notification of revisions in per diem rates to agencies and establishments outside the Department of Defense. For more information or questions about per diem rates, please contact your local travel office. Civilian Bulletin 307 includes updated rates for American Samoa.

    Dated: October 26, 2017. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense. Country/state Locality Season start Season end Lodging M&IE Total per diem Effective date ALASKA [OTHER] 01/01 12/31 120 88 208 03/01/2017 ALASKA ADAK 05/01 09/30 192 60 252 03/01/2017 ALASKA ADAK 10/01 04/30 150 60 210 03/01/2017 ALASKA ANCHORAGE [INCL NAV RES] 10/01 05/15 199 94 293 03/01/2017 ALASKA ANCHORAGE [INCL NAV RES] 05/16 09/30 229 94 323 03/01/2017 ALASKA BARROW 10/01 04/30 205 89 294 03/01/2017 ALASKA BARROW 05/01 09/30 238 89 327 03/01/2017 ALASKA BARTER ISLAND LRRS 01/01 12/31 120 88 208 03/01/2017 ALASKA BETHEL 01/01 12/31 219 108 327 03/01/2017 ALASKA BETTLES 01/01 12/31 175 70 245 03/01/2017 ALASKA CAPE LISBURNE LRRS 01/01 12/31 120 88 208 03/01/2017 ALASKA CAPE NEWENHAM LRRS 01/01 12/31 120 88 208 03/01/2017 ALASKA CAPE ROMANZOF LRRS 01/01 12/31 120 88 208 03/01/2017 ALASKA CLEAR AB 01/01 12/31 120 88 208 03/01/2017 ALASKA COLD BAY LRRS 01/01 12/31 120 88 208 03/01/2017 ALASKA COLDFOOT 01/01 12/31 165 70 235 10/01/2006 ALASKA COPPER CENTER 05/15 09/15 169 84 253 03/01/2017 ALASKA COPPER CENTER 09/16 05/14 97 84 181 03/01/2017 ALASKA CORDOVA 01/01 12/31 140 111 251 03/01/2017 ALASKA CRAIG 10/01 03/31 90 78 168 03/01/2017 ALASKA CRAIG 04/01 09/30 254 78 332 03/01/2017 ALASKA DEADHORSE 01/01 12/31 170 51 221 03/01/2016 ALASKA DELTA JUNCTION 05/01 09/30 169 78 247 03/01/2017 ALASKA DELTA JUNCTION 10/01 04/30 139 78 217 03/01/2017 ALASKA DENALI NATIONAL PARK 06/01 08/31 185 86 271 03/01/2017 ALASKA DENALI NATIONAL PARK 09/01 05/31 139 86 225 03/01/2017 ALASKA DILLINGHAM 10/02 05/14 220 85 305 03/01/2017 ALASKA DILLINGHAM 05/15 10/01 350 85 435 03/01/2017 ALASKA DUTCH HARBOR-UNALASKA 01/01 12/31 142 101 243 03/01/2017 ALASKA EARECKSON AIR STATION 01/01 12/31 146 74 220 07/01/2016 ALASKA EIELSON AFB 05/15 09/15 154 90 244 03/01/2017 ALASKA EIELSON AFB 09/16 05/14 75 90 165 03/01/2017 ALASKA ELFIN COVE 01/01 12/31 275 86 361 03/01/2017 ALASKA ELMENDORF AFB 10/01 05/15 199 94 293 03/01/2017 ALASKA FAIRBANKS 05/15 09/15 154 90 244 03/01/2017 ALASKA FAIRBANKS 09/16 05/14 75 90 165 03/01/2017 ALASKA FOOTLOOSE 01/01 12/31 175 18 193 10/01/2002 ALASKA FORT YUKON LRRS 01/01 12/31 120 88 208 03/01/2017 ALASKA FT. GREELY 05/01 09/30 169 78 247 03/01/2017 ALASKA FT. GREELY 10/01 04/30 139 78 217 03/01/2017 ALASKA FT. RICHARDSON 05/16 09/30 229 94 323 03/01/2017 ALASKA FT. RICHARDSON 10/01 05/15 199 94 293 03/01/2017 ALASKA FT. WAINWRIGHT 09/16 05/14 75 90 165 03/01/2017 ALASKA FT. WAINWRIGHT 05/15 09/15 154 90 244 03/01/2017 ALASKA GAMBELL 01/01 12/31 133 51 184 03/01/2016 ALASKA GLENNALLEN 05/15 09/15 169 84 253 03/01/2017 ALASKA GLENNALLEN 09/16 05/14 97 84 181 03/01/2017 ALASKA HAINES 01/01 12/31 107 101 208 01/01/2011 ALASKA HEALY 06/01 08/31 185 86 271 03/01/2017 ALASKA HEALY 09/01 05/31 139 86 225 03/01/2017 ALASKA HOMER 05/01 09/30 200 70 270 03/01/2017 ALASKA HOMER 10/01 04/30 160 70 230 03/01/2017 ALASKA JB ELMENDORF-RICHARDSON 10/01 05/15 199 94 293 03/01/2017 ALASKA JB ELMENDORF-RICHARDSON 05/16 09/30 229 94 323 03/01/2017 ALASKA JUNEAU 05/01 09/15 189 106 295 03/01/2017 ALASKA JUNEAU 09/16 04/30 169 106 275 03/01/2017 ALASKA KAKTOVIK 01/01 12/31 165 86 251 10/01/2002 ALASKA KAVIK CAMP 01/01 12/31 250 51 301 03/01/2016 ALASKA KENAI-SOLDOTNA 05/01 09/30 179 103 282 03/01/2017 ALASKA KENAI-SOLDOTNA 10/01 04/30 99 103 202 03/01/2017 ALASKA KENNICOTT 01/01 12/31 295 89 384 03/01/2017 ALASKA KETCHIKAN 05/01 09/01 243 96 339 03/01/2017 ALASKA KETCHIKAN 09/02 04/30 220 96 316 03/01/2017 ALASKA KING SALMON 05/01 10/01 225 91 316 10/01/2002 ALASKA KING SALMON 10/02 04/30 125 81 206 10/01/2002 ALASKA KING SALMON LRRS 01/01 12/31 120 88 208 03/01/2017 ALASKA KLAWOCK 04/01 09/30 254 78 332 03/01/2017 ALASKA KLAWOCK 10/01 03/31 90 78 168 03/01/2017 ALASKA KODIAK 10/01 04/30 152 90 242 03/01/2017 ALASKA KODIAK 05/01 09/30 180 90 270 03/01/2017 ALASKA KOTZEBUE 01/01 12/31 299 98 397 03/01/2017 ALASKA KULIS AGS 10/01 05/15 199 94 293 03/01/2017 ALASKA KULIS AGS 05/16 09/30 229 94 323 03/01/2017 ALASKA MCCARTHY 01/01 12/31 295 89 384 03/01/2017 ALASKA MURPHY DOME 09/16 05/14 75 90 165 03/01/2017 ALASKA MURPHY DOME 05/15 09/15 154 90 244 03/01/2017 ALASKA NOME 05/01 09/30 185 96 281 03/01/2017 ALASKA NOME 10/01 04/30 165 96 261 03/01/2017 ALASKA NOSC ANCHORAGE 05/16 09/30 229 94 323 03/01/2017 ALASKA NOSC ANCHORAGE 10/01 05/15 199 94 293 03/01/2017 ALASKA NUIQSUT 01/01 12/31 234 51 285 03/01/2016 ALASKA OLIKTOK LRRS 01/01 12/31 120 88 208 03/01/2017 ALASKA PETERSBURG 01/01 12/31 120 88 208 03/01/2017 ALASKA POINT BARROW LRRS 01/01 12/31 120 88 208 03/01/2017 ALASKA POINT HOPE 01/01 12/31 175 81 256 03/01/2017 ALASKA POINT LAY 01/01 12/31 295 51 346 03/01/2017 ALASKA POINT LAY LRRS 01/01 12/31 295 51 346 03/01/2017 ALASKA POINT LONELY LRRS 01/01 12/31 120 88 208 03/01/2017 ALASKA PORT ALEXANDER 10/01 12/31 155 51 206 03/01/2017 ALASKA PORT ALEXANDER 01/01 09/30 165 51 216 03/01/2017 ALASKA PORT ALSWORTH 01/01 12/31 135 88 223 10/01/2002 ALASKA PRUDHOE BAY 01/01 12/31 170 51 221 03/01/2016 ALASKA SELDOVIA 05/01 09/30 200 70 270 03/01/2017 ALASKA SELDOVIA 10/01 04/30 160 70 230 03/01/2017 ALASKA SEWARD 10/01 04/30 159 85 244 03/01/2017 ALASKA SEWARD 05/01 09/30 279 85 364 03/01/2017 ALASKA SITKA-MT. EDGECUMBE 01/01 12/31 200 98 298 03/01/2016 ALASKA SKAGWAY 09/02 04/30 220 96 316 03/01/2017 ALASKA SKAGWAY 05/01 09/01 243 96 339 03/01/2017 ALASKA SLANA 10/01 04/30 99 55 154 02/01/2005 ALASKA SLANA 05/01 09/30 139 55 194 02/01/2005 ALASKA SPARREVOHN LRRS 01/01 12/31 120 88 208 03/01/2017 ALASKA SPRUCE CAPE 10/01 04/30 152 90 242 03/01/2017 ALASKA SPRUCE CAPE 05/01 09/30 180 90 270 03/01/2017 ALASKA ST. GEORGE 01/01 12/31 220 51 271 03/01/2016 ALASKA TALKEETNA 01/01 12/31 100 89 189 10/01/2002 ALASKA TANANA 10/01 04/30 165 96 261 03/01/2017 ALASKA TANANA 05/01 09/30 185 96 281 03/01/2017 ALASKA TATALINA LRRS 01/01 12/31 120 88 208 03/01/2017 ALASKA TIN CITY LRRS 01/01 12/31 120 88 208 03/01/2017 ALASKA TOK 01/01 12/31 99 97 196 03/01/2017 ALASKA VALDEZ 09/10 04/30 127 110 237 03/01/2017 ALASKA VALDEZ 05/01 09/09 185 110 295 03/01/2017 ALASKA WAINWRIGHT 01/01 12/31 175 83 258 01/01/2011 ALASKA WAKE ISLAND DIVERT AIRFIELD 01/01 12/31 120 88 208 03/01/2017 ALASKA WASILLA 10/01 04/30 90 89 179 03/01/2017 ALASKA WASILLA 05/01 09/30 170 89 259 03/01/2017 ALASKA WRANGELL 05/01 09/01 243 96 339 03/01/2017 ALASKA WRANGELL 09/02 04/30 220 96 316 03/01/2017 ALASKA YAKUTAT 01/01 12/31 105 94 199 01/01/2011 AMERICAN SAMOA AMERICAN SAMOA 01/01 12/31 139 77 216 11/01/2017 AMERICAN SAMOA PAGO PAGO 01/01 12/31 139 77 216 11/01/2017 GUAM GUAM (INCL ALL MIL INSTAL) 01/01 12/31 159 87 246 07/01/2015 GUAM JOINT REGION MARIANAS (ANDERSEN) 01/01 12/31 159 87 246 07/01/2015 GUAM JOINT REGION MARIANAS (NAVAL BASE) 01/01 12/31 159 87 246 07/01/2015 GUAM TAMUNING 01/01 12/31 159 87 246 12/01/2015 HAWAII [OTHER] 01/01 12/31 199 117 316 08/01/2017 HAWAII CAMP H M SMITH 01/01 12/31 177 138 315 08/01/2017 HAWAII EASTPAC NAVAL COMP TELE AREA 01/01 12/31 177 138 315 08/01/2017 HAWAII FT. DERUSSEY 01/01 12/31 177 138 315 08/01/2017 HAWAII FT. SHAFTER 01/01 12/31 177 138 315 08/01/2017 HAWAII HICKAM AFB 01/01 12/31 177 138 315 08/01/2017 HAWAII HILO 01/01 12/31 199 117 316 08/01/2017 HAWAII HONOLULU 01/01 12/31 177 138 315 08/01/2017 HAWAII ISLE OF HAWAII: HILO 01/01 12/31 199 117 316 08/01/2017 HAWAII ISLE OF HAWAII: OTHER 12/18 03/25 239 161 400 08/01/2017 HAWAII ISLE OF HAWAII: OTHER 03/26 12/17 189 161 350 08/01/2017 HAWAII ISLE OF KAUAI 01/01 12/31 325 135 460 04/01/2016 HAWAII ISLE OF MAUI 01/01 12/31 269 160 429 08/01/2017 HAWAII ISLE OF OAHU 01/01 12/31 177 138 315 08/01/2017 HAWAII JB PEARL HARBOR-HICKAM 01/01 12/31 177 138 315 08/01/2017 HAWAII KAPOLEI 01/01 12/31 177 138 315 08/01/2017 HAWAII KEKAHA PACIFIC MISSILE RANGE FAC 01/01 12/31 325 135 460 04/01/2016 HAWAII KILAUEA MILITARY CAMP 01/01 12/31 199 117 316 08/01/2017 HAWAII LANAI 01/01 12/31 254 111 365 08/01/2017 HAWAII LIHUE 01/01 12/31 325 135 460 04/01/2016 HAWAII LUALUALEI NAVAL MAGAZINE 01/01 12/31 177 138 315 08/01/2017 HAWAII MCB HAWAII 01/01 12/31 177 138 315 08/01/2017 HAWAII MOLOKAI 01/01 12/31 176 115 291 08/01/2017 HAWAII NOSC PEARL HARBOR 01/01 12/31 177 138 315 08/01/2017 HAWAII PEARL HARBOR 01/01 12/31 177 138 315 08/01/2017 HAWAII PMRF BARKING SANDS 01/01 12/31 325 135 460 10/01/2016 HAWAII SCHOFIELD BARRACKS 01/01 12/31 177 138 315 08/01/2017 HAWAII TRIPLER ARMY MEDICAL CENTER 01/01 12/31 177 138 315 08/01/2017 HAWAII WAHIAWA NCTAMS PAC 01/01 12/31 177 138 315 08/01/2017 HAWAII WHEELER ARMY AIRFIELD 01/01 12/31 177 138 315 08/01/2017 MIDWAY ISLANDS MIDWAY ISLANDS 01/01 12/31 125 81 206 08/01/2017 NORTHERN MARIANA ISLANDS [OTHER] 01/01 12/31 69 84 153 08/01/2017 NORTHERN MARIANA ISLANDS ROTA 01/01 12/31 130 107 237 07/01/2015 NORTHERN MARIANA ISLANDS SAIPAN 01/01 12/31 161 101 262 08/01/2017 NORTHERN MARIANA ISLANDS TINIAN 01/01 12/31 69 84 153 08/01/2017 PUERTO RICO [OTHER] 01/01 12/31 109 112 221 06/01/2012 PUERTO RICO AGUADILLA 01/01 12/31 171 84 255 11/01/2015 PUERTO RICO BAYAMON 12/01 05/31 195 88 283 12/01/2015 PUERTO RICO BAYAMON 06/01 11/30 167 88 255 12/01/2015 PUERTO RICO CAROLINA 12/01 05/31 195 88 283 12/01/2015 PUERTO RICO CAROLINA 06/01 11/30 167 88 255 12/01/2015 PUERTO RICO CEIBA 01/01 12/31 139 92 231 10/01/2012 PUERTO RICO CULEBRA 01/01 12/31 150 98 248 03/01/2012 PUERTO RICO FAJARDO [INCL ROOSEVELT RDS NAVSTAT] 01/01 12/31 139 92 231 10/01/2012 PUERTO RICO FT. BUCHANAN [INCL GSA SVC CTR, GUAYNABO] 12/01 05/31 195 88 283 12/01/2015 PUERTO RICO FT. BUCHANAN [INCL GSA SVC CTR, GUAYNABO] 06/01 11/30 167 88 255 12/01/2015 PUERTO RICO HUMACAO 01/01 12/31 139 92 231 10/01/2012 PUERTO RICO LUIS MUNOZ MARIN IAP AGS 12/01 05/31 195 88 283 12/01/2015 PUERTO RICO LUIS MUNOZ MARIN IAP AGS 06/01 11/30 167 88 255 12/01/2015 PUERTO RICO LUQUILLO 01/01 12/31 139 92 231 10/01/2012 PUERTO RICO MAYAGUEZ 01/01 12/31 109 112 221 09/01/2010 PUERTO RICO PONCE 01/01 12/31 149 89 238 09/01/2012 PUERTO RICO RIO GRANDE 01/01 12/31 169 123 292 06/01/2012 PUERTO RICO SABANA SECA [INCL ALL MILITARY] 12/01 05/31 195 88 283 12/01/2015 PUERTO RICO SABANA SECA [INCL ALL MILITARY] 06/01 11/30 167 88 255 12/01/2015 PUERTO RICO SAN JUAN & NAV RES STA 06/01 11/30 167 88 255 12/01/2015 PUERTO RICO SAN JUAN & NAV RES STA 12/01 05/31 195 88 283 12/01/2015 PUERTO RICO VIEQUES 01/01 12/31 175 95 270 03/01/2012 VIRGIN ISLANDS (U.S.) ST. CROIX 12/15 04/14 299 116 415 06/01/2015 VIRGIN ISLANDS (U.S.) ST. CROIX 04/15 12/14 247 110 357 06/01/2015 VIRGIN ISLANDS (U.S.) ST. JOHN 12/04 04/30 230 113 343 08/01/2015 VIRGIN ISLANDS (U.S.) ST. JOHN 05/01 12/03 170 107 277 08/01/2015 VIRGIN ISLANDS (U.S.) ST. THOMAS 04/15 12/15 249 110 359 03/01/2017 VIRGIN ISLANDS (U.S.) ST. THOMAS 12/16 04/14 339 110 449 03/01/2017 WAKE ISLAND WAKE ISLAND 01/01 12/31 129 70 199 07/01/2016
    [FR Doc. 2017-23644 Filed 10-30-17; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF DEFENSE Department of the Army, Corps of Engineers Inland Waterways Users Board Meeting Notice AGENCY:

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

    ACTION:

    Notice; correction.

    SUMMARY:

    Due to circumstances beyond the control of the Designated Federal Officer and the Department of Defense, the Inland Waterways Users Board was unable to provide public notification changing the meeting location of its meeting of November 3, 2017, which was previously announced in the Federal Register on September 29, 2017 (82 FR 45583). Accordingly, the Advisory Committee Management Officer for the Department of Defense, waives the 15-calendar day notification requirement.

    The notice of an open meeting scheduled for November 3, 2017 published in the Federal Register on September 29, 2017 (82 FR 45583) has a new meeting location. It will now be held at the U.S. Army Corps of Engineers Vicksburg District Office Building, main Multi-purpose Conference Room, 4155 East Clay Street, Vicksburg, MS 39183.

    FOR FURTHER INFORMATION CONTACT:

    Mr. Mark R. Pointon, the Designated Federal Officer (DFO) for the committee, in writing at the Institute for Water Resources, U.S. Army Corps of Engineers, ATTN: CEIWR-GM, 7701 Telegraph Road, Casey Building, Alexandria, VA 22315-3868; by telephone at 703-428-6438; and by email at [email protected] Alternatively, contact Mr. Kenneth E. Lichtman, the Alternate Designated Federal Officer (ADFO), in writing at the Institute for Water Resources, U.S. Army Corps of Engineers, ATTN: CEIWR-GW, 7701 Telegraph Road, Casey Building, Alexandria, VA 22315-3868; by telephone at 703-428-8083; and by email at [email protected]

    SUPPLEMENTARY INFORMATION:

    Brenda S. Bowen, Army Federal Register Liaison Officer. [FR Doc. 2017-23633 Filed 10-30-17; 8:45 am] BILLING CODE 3720-58-P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. ER18-155-000] EnPowered; 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 EnPowered`s application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.

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

    Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is November 14, 2017.

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

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

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

    Dated: October 25, 2017. Nathaniel J. Davis, Sr., Deputy Secretary. [FR Doc. 2017-23771 Filed 10-30-17; 8:45 am] BILLING CODE 6717-01-P
    ENVIRONMENTAL PROTECTION AGENCY [FRL-9970-13-OW] Information Session; Implementation of the Water Infrastructure Finance and Innovation Act of 2014 AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice.

    SUMMARY:

    The Environmental Protection Agency (EPA) is announcing plans to hold information sessions on: November 8, 2017 in Denver, Colorado; November 16, 2017 in Nashville, Tennessee; and November 29, 2017 in Lenexa, Kansas. In addition, EPA will host a series of webinars covering the same topics on December 6, 13, and 20, 2017. The purpose of both the sessions and webinars is to provide prospective borrowers with a better understanding of the Water Infrastructure Finance and Innovation Act (WIFIA) program requirements and application process.

    Under WIFIA, EPA can provide long-term, low-cost supplemental loans and loan guarantees for regionally and nationally significant water infrastructure projects. During each information session, EPA will provide an overview of the program's statutory and eligibility requirements, application and selection process, and creditworthiness assessment. It will also explain the financial benefits of WIFIA credit assistance and provide tips for completing the application materials. The intended audience is prospective borrowers including municipal entities, corporations, partnerships, and State Revolving Fund programs, as well as the private and non-governmental organizations that support prospective borrowers.

    DATES:

    The session in Denver, Colorado will be held on November 8, 2017 from 9:00 a.m.-3:00 p.m. (MT). The session in Nashville, Tennessee will be held on November 16, 2017 from 9:00 a.m.-3:00 p.m. (CT). The session in Lenexa, Kansas will be held on November 29, 2017 from 9:00 a.m.-3:00 p.m. (CT).

    ADDRESSES:

    The session in Denver will be held at: US EPA Region 8 Headquarters, 1595 Wynkoop Street, Denver, Colorado 80202. The session in Nashville will be held at: William R. Snodgrass—Tennessee Tower, 312 Rosa L. Parks Avenue, Conference Center North, 3rd Floor, Room D, Nashville, Tennessee 37243. The session in Lenexa will be held at: EPA Region 7 Headquarters, 11201 Renner Boulevard, Lenexa, Kansas 66219.

    Webinar Dates: The webinar “Overview of the WIFIA program” will be held on December 6, 2017 from 2:00-3:30 ET. The webinar “Benefits of Financing with WIFIA Loans” will be held on December 13, 2017 from 2:00-3:30 ET. The webinar “WIFIA Application Process: Tips for Submitting a Letter of Interest” will be held December 20, 2017, 2:00-3:30 ET.

    To Register: Registration information for both the information sessions and the webinars is available at https://www.epa.gov/wifia.

    FOR FURTHER INFORMATION CONTACT:

    For further information about this notice, including registration information, contact Karen Fligger, EPA Headquarters, Office of Water, Office of Wastewater Management at tel.: 202-564-2992; or email: [email protected]. Members of the public are invited to participate in the session as capacity allows.

    Authority:

    Water Infrastructure Finance and Innovation Act, 33 U.S.C. 3901 et. seq.

    Dated: October 18, 2017. Andrew D. Sawyers, Director, Office of Wastewater Management.
    [FR Doc. 2017-23567 Filed 10-30-17; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [FRL-9970-18-Region 6] Notice of Proposed Administrative Settlement Pursuant to the Comprehensive Environmental Response, Compensation, and Liability Act AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice; request for public comment.

    SUMMARY:

    In accordance with section 122(h)(1) of the Comprehensive Environmental Response, Compensation, and Liability Act, as amended (“CERCLA”), notice is hereby given of a proposed administrative settlement concerning the Bandera Road Ground Water Plume Superfund Site, located in City of Leon Valley, Bexar County, Texas.

    The settlement requires Savings Square Partners, Ltd., settling party, to pay a total of $1,820,000 as payment of past response costs to the Hazardous Substances Superfund. The settlement includes a covenant not to sue pursuant to sections 106 and 107(a) of CERCLA, 42 U.S.C. 9606 and 9607(a).

    For thirty (30) days following the date of publication of this notice, the Agency will receive written comments relating to this notice and will receive written comments relating to the settlement. The Agency will consider all comments received and may modify or withdraw its consent to the settlement if comments received disclose facts or considerations which indicate that the settlement is inappropriate, improper, or inadequate. The Agency's response to any comments received will be available for public inspection at 1445 Ross Avenue, Dallas, Texas 75202-2733.

    DATES:

    Comments must be submitted on or before November 30, 2017.

    ADDRESSES:

    The proposed settlement and additional background information relating to the settlement are available for public inspection at 1445 Ross Avenue, Dallas, Texas 75202-2733. A copy of the proposed settlement may be obtained from Lawrence Andrews, 1445 Ross Avenue, Dallas, Texas 75202-2733 or by calling (214) 665-7397. Comments should reference the Bandera Road Ground Water Plume Superfund Site, City of Leon, Bexar County, Texas, and EPA Docket Number 06-06-17 and should be addressed to Lawrence Andrews at the address listed above.

    FOR FURTHER INFORMATION CONTACT:

    Jacob Piehl, 1445 Ross Avenue, Dallas, Texas 75202-2733 or call (214) 665-2138.

    Dated: October 16, 2017. Samuel Coleman, Acting Regional Administrator, Region 6.
    [FR Doc. 2017-23684 Filed 10-30-17; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [EPA-R05-OAR-2017-0212; FRL-9970-15-Region 5] Adequacy Status of the Kenosha County, Wisconsin Area for Submitted 8-Hour Ozone Attainment Demonstration for Transportation Conformity Purposes AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice of adequacy.

    SUMMARY:

    In this notice, the Environmental Protection Agency (EPA) is notifying the public that we find that the motor vehicle emissions budgets (MVEBs) for volatile organic compounds (VOCs) and oxides of nitrogen (NOX) in the Kenosha County, Wisconsin ozone nonattainment area are adequate for use in transportation conformity determinations. Wisconsin submitted an Attainment Demonstration for Kenosha County on April 17, 2017. As a result of our finding, this area must use these MVEBs from the submitted Attainment Demonstration for future transportation conformity determinations.

    DATES:

    This finding is effective November 15, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Michael Leslie, Environmental Engineer, Control Strategies Section (AR-18J), Air Programs Branch, Air and Radiation Division, United States Environmental Protection Agency, Region 5, 77 West Jackson Boulevard, Chicago, Illinois 60604, (312) 353-6680, [email protected]

    SUPPLEMENTARY INFORMATION:

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

    Background

    Today's notice is an announcement of a finding that we have already made. On September 6, 2017, EPA sent a letter to the Wisconsin Department of Natural Resources stating that the 2017 and 2018 MVEBs contained in the Attainment Demonstration for Kenosha County in Wisconsin are adequate for transportation conformity purposes. Receipt of these MVEBs was announced on EPA's transportation conformity Web site, and no comments were submitted. The finding is available at EPA's conformity Web site: https://www.epa.gov/state-and-local-transportation/adequacy-review-state-implementation-plan-sip-submissions-conformity.

    The 2017 and 2018 MVEBs, in tons per day (tpd), for VOCs and NOX for the Kenosha County, Wisconsin area are as follows:

    Kenosha County NOX (tpd) VOCs (tpd) 2017 3.05 1.56 2018 2.75 1.44

    Transportation conformity is required by section 176(c) of the Clean Air Act. EPA's conformity rule requires that transportation plans, programs, and projects conform to state air quality implementation plans and establishes the criteria and procedures for determining whether or not they do conform. Conformity to a State Implementation Plan (SIP) means that transportation activities will not produce new air quality violations, worsen existing violations, or delay timely attainment of the national ambient air quality standards.

    The criteria by which we determine whether a SIP's MVEBs are adequate for transportation conformity purposes are outlined in 40 CFR 93.118(e)(4). Please note that an adequacy review is separate from EPA's completeness review, and it also should not be used to prejudge EPA's ultimate approval of the SIP. Even if we find a budget adequate, the SIP could later be disapproved.

    Authority:

    42 U.S.C. 7401-7671 q.

    Dated: October 17, 2017. Robert A. Kaplan, Acting Regional Administrator, Region 5.
    [FR Doc. 2017-23685 Filed 10-30-17; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OA-2017-0600; FRL-9968-25-OA] Fast-41 Best Practices: Delegated State Permitting Programs AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice; request for public comment.

    SUMMARY:

    On January 18, 2017, the Federal Permitting Improvement Steering Council, published Recommended Best Practices for Environmental Reviews and Authorizations for Infrastructure Projects, available at https://www.permits.performance.gov. In accordance with Section 41006 of the Fixing America's Surface Transportation Act (FAST-41), the Environmental Protection Agency (EPA) is seeking public comment. Specifically, EPA is seeking feedback on whether any of the best practices are generally applicable on a delegation or authorization-wide basis to permitting under FAST-41.

    DATES:

    Comments must be received on or before November 20, 2017.

    ADDRESSES:

    Submit comments and additional materials, identified by docket EPA-HQ-OA-2017-0600 to the Federal eRulemaking Portal: https://www.regulations.gov. Follow the online instructions for submitting comments. Once submitted, comments cannot be edited or removed from Regulations.gov. The EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission (i.e., on the web, cloud, or other file sharing system). For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit https://www2.epa.gov/dockets/commenting-epa-dockets.

    FOR FURTHER INFORMATION CONTACT:

    Laura Gentile, Office of Policy, Mail Code 1104-A, U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue NW., Washington, DC 20460; telephone number: 202-564-3158; email address: [email protected]

    SUPPLEMENTARY INFORMATION:

    FAST-41 seeks to enhance coordination and transparency of Federal environmental reviews and authorizations required prior to construction of covered infrastructure projects. This statute applies specifically to authorizations and environmental reviews which are led by and/or issued by a Federal agency. However, states may choose to participate in the environmental review and authorization process under FAST-41. This statute only applies to “covered projects” which 42 U.S.C. 4370m(6)(A) defines as:

    The term “covered project” means any activity in the United States that requires authorization or environmental review by a Federal agency involving construction of infrastructure for renewable or conventional energy production, electricity transmission, surface transportation, aviation, ports and waterways, water resource projects, broadband, pipelines, manufacturing, or any other sector as determined by a majority vote of the Council that—

    (i)(I) is subject to NEPA;

    (II) is likely to require a total investment of more than $200,000,000; and

    (III) does not qualify for abbreviated authorization or environmental review processes under any applicable law; or

    (ii) is subject to NEPA and the size and complexity of which, in the opinion of the Council, make the project likely to benefit from enhanced oversight and coordination, including a project likely to require—

    (I) authorization from or environmental review involving more than 2 Federal agencies; or

    (II) the preparation of an environmental impact statement under NEPA.

    FAST-41 required the establishment of the Federal Permitting Improvement Steering Council (FPISC) which is a council that includes a chair and then representatives of certain Federal agencies, the Chairman of the Council on Environmental Quality, and the Director of the Office of Management and Budget. Council agencies include agencies that may be involved in authorization or environmental review of a covered project. The EPA is one such agency and is represented on the FPISC. Pursuant to FAST-41, the FPISC is charged with issuing recommendations on best practices to support the goals of FAST-41. See, e.g., 42 U.S.C. 4370m-1(c)(2)(B). In essence, the best practices are aimed at streamlining and improving the process by which the Federal government undertakes environmental reviews and authorizations for covered projects.

    States may voluntarily choose to participate in the FAST-41 process and make subject to the process all State agencies that have jurisdiction, are required to undertake a review or analysis, or are required to make a determination on issuing a permit, license or other approval for a covered project.

    Current Request for Comment

    On January 18, 2017, the FPISC published a document titled, Recommended Best Practices for Environmental Reviews and Authorizations for Infrastructure Projects, which is available online at https://www.permits.performance.gov. This document identifies best practices consistent with the FAST-41 guidelines described in 42 U.S.C. 4370m-1(c)(2)(B). Specifically, these best practices regard:

    42 U.S.C. 4370m-1(c)(2)(B)

    “(i) enhancing early stakeholder engagement, including fully considering and, as appropriate, incorporating recommendations provided in public comments on any proposed covered project;

    (ii) ensuring timely decisions regarding environmental reviews and authorizations, including through the development of performance metrics;

    (iii) improving coordination between Federal and non-Federal governmental entities, including through the development of common data standards and terminology across agencies;

    (iv) increasing transparency;

    (v) reducing information collection requirements and other administrative burdens on agencies, project sponsors, and other interested parties;

    (vi) developing and making available to applicants appropriate geographic information systems and other tools;

    (vii) creating and distributing training materials useful to Federal, State, tribal, and local permitting officials; and

    (viii) addressing other aspects of infrastructure permitting, as determined by the Council.”

    42 U.S.C. 4370m-1(c)(2)(B)

    Under a number of federal environmental laws, the EPA delegates, approves, or authorizes state governments to issue permits or other authorizations under these laws. The EPA has already taken a number of steps related to best practices for delegated and authorized state permitting programs. These include establishing minimum program requirements for authorized and delegated programs consistent with the underlying statutory obligations.

    In addition, the EPA regularly communicates with delegated and authorized programs regarding program implementation and oversight. One example of this is that in 2016, the EPA initiated an agency-wide effort, with the consultation and collaboration of stakeholder associations throughout, to articulate a common set of principles and best practices for promoting the efficiency and effectiveness of delegated, authorized, and approved state permitting programs. On August 30, 2016, the EPA formally transmitted the final principles and best practices for permitting to the Environmental Council of the States. See Promoting Environmental Program Health and Integrity: Principles and Best Practices for Oversight of State Permitting Programs, available online at https://www.epa.gov/sites/production/files/2016-10/documents/principles_and_best_practices_for_oversight_of_state_permitting_programs.pdf. These best practices and principles dovetail with the FPISC's best practices.

    42 U.S.C. 4370m-5(a)(1)

    Consistent with the EPA's obligation under 42 U.S.C. 4370m-5(a)(1), the EPA is now seeking public comment to determine whether and the extent to which any of the best practices identified by the FPISC are generally applicable on a delegation- or authorization-wide basis to permitting under FAST-41. This document satisfies EPA's obligation under FAST-41 to solicit public participation on the FPISC best practices.

    Authority:

    Public Law 114-94, div. D, title XLI, sec. 41006(a)(1), Dec. 4, 2015, 129 Stat. 1758.

    Dated: October 25, 2017.

    Samantha K. Dravis, Associate Administrator for Policy.
    [FR Doc. 2017-23686 Filed 10-30-17; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OW-2015-0714; FRL-9970-21-OW] Notice of a Public Meeting of the National Drinking Water Advisory Council AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice of a public meeting.

    SUMMARY:

    The U.S. Environmental Protection Agency (EPA) is announcing a public meeting of the National Drinking Water Advisory Council (NDWAC), as authorized under the Safe Drinking Water Act. During this meeting, the NDWAC will focus discussions on developing recommendations for the EPA Administrator on Health Advisory Communications.

    DATES:

    The meeting on December 7, 2017, will be held from 9:30 a.m. to 4:00 p.m., eastern time; and December 8, 2017, from 8:30 a.m. to noon, eastern time.

    ADDRESSES:

    The public meeting will be held at the U.S. Environmental Protection Agency, William Jefferson Clinton (WJC) East Building, Rooms 1117A & B, 1201 Constitution Avenue NW., Washington, DC 20460.

    FOR FURTHER INFORMATION CONTACT:

    For more information about this meeting or to request written materials, contact Tracey Ward of the Office of Ground Water and Drinking Water, U.S. Environmental Protection Agency; by phone at 202-564-3796 or by email at [email protected] For additional information about the NDWAC meeting, please visit http://water.epa.gov/drink/ndwac/ or www.regulations.gov (search for Docket ID No. EPA-HQ-OW-2015-0714).

    SUPPLEMENTARY INFORMATION:

    Details About Participating in the Meeting: Teleconferencing will be available during the meeting. The number of teleconference connections available for the meeting is limited and will be offered on a first-come, first-served basis. The teleconference number is (1) 866-299-3188; when prompted, enter conference code 202 564-7347.

    Dated: October 23, 2017. Peter Grevatt, Director, Office of Ground Water and Drinking Water.
    [FR Doc. 2017-23566 Filed 10-30-17; 8:45 am] BILLING CODE 6560-50-P
    FEDERAL COMMUNICATIONS COMMISSION [OMB 3060-1056] 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), 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 January 2, 2018. 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 No.: 3060-1056.

    Title: Application for International Broadcast Station License.

    Form No.: FCC Form 421-IB.

    Type of Review: Extension of a currently approved information collection.

    Respondents: Business or other for-profit.

    Number of Respondents: 10 respondents; 10 responses.

    Estimated Time per Response: 6 hours per response.

    Frequency of Response: On occasion reporting requirement.

    Obligation to Respond: Required to obtain or retain benefits. The statutory authority for this information collection is contained in section 325(c) of the Communications Act of 1934, as amended.

    Total Annual Burden: 60 hours.

    Annual Cost Burden: $40,500.

    Privacy Act Impact Assessment: No impact(s).

    Nature and Extent of Confidentiality: In general, there is no need for confidentiality with this collection of information.

    Needs and Uses: This collection will be submitted to the Office of Management and Budget (OMB) as an extension following the 60-day comment period in order to obtain the full three-year clearance from OMB.

    The Federal Communications Commission (“Commission”) plans to implement and release to the public an “Application for an International Broadcast Station License” (FCC Form 421-IB). The FCC Form 421-IB will be used by applicants to request licenses to operate international broadcast stations. The FCC Form 421-IB has not been implemented yet due to a lack of budget resources and technical staff. After the form has been implemented and the Commission has obtained final approval from the OMB, applicants will file the FCC Form 421-IB with the Commission in lieu of the “Application for an International, Experimental Television, Experimental Facsimile, or a Developmental Broadcast Station,” (FCC Form 310). (Note: The Commission received approval from the OMB for the FCC Form 310 under OMB Control No 3060-1035). In the interim, applicants will continue to file the FCC Form 310 with the Commission.

    The Commission stated previously that the FCC Form 421-IB will be available to applicants in the International Bureau Filing System (“MyIBFS”) after its development. The Commission plans to develop a new Consolidated Licensing System (CLS) that will replace MyIBFS. Therefore, the FCC Form 421-IB will be made available to the public in CLS instead of MyIBFS.

    The information collected is used by the Commission to assign frequencies for use by international broadcast stations, to grant authority to operate such stations and to determine if interference or adverse propagation conditions exist that may impact the operation of such stations. If the Commission did not collect this information, it would not be in a position to effectively coordinate spectrum for international broadcasters or to act for entities in times of frequency interference or adverse propagation conditions. The orderly nature of the provision of international broadcast service would be in jeopardy without the Commission's involvement.

    Federal Communications Commission. Marlene H. Dortch, Secretary, Office of the Secretary.
    [FR Doc. 2017-23625 Filed 10-30-17; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL COMMUNICATIONS COMMISSION [OMB 3060-0798; OMB 3060-0800] Information Collections 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 January 2, 2018. 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: 3060-0798.

    Title: FCC Application for Radio Service Authorization; Wireless Telecommunications Bureau; Public Safety and Homeland Security Bureau.

    Form Number: FCC Form 601.

    Type of Review: Revision of a currently approved collection.

    Respondents: Individuals and households; Business or other for-profit entities; Not-for-profit institutions; and State, local or tribal governments.

    Number of Respondents and Responses: 253,320 respondents and 253,320 responses.

    Estimated Time per Response: 0.5-1.25 hours.

    Frequency of Response: Recordkeeping requirement, third party disclosure requirement, on occasion reporting requirement and periodic reporting requirement.

    Obligation to Respond: Required to obtain or retain benefits. The statutory authority for this collection of information is contained in 47 U.S.C. 151, 152, 154, 154(i), 155(c), 157, 201, 202, 208, 214, 301, 302a, 303, 307, 308, 309, 310, 311, 314, 316, 319, 324, 331, 332, 333, 336, 534, 535 and 554.

    Total Annual Burden: 222,055 hours.

    Total Annual Cost: $71,306,250.

    Privacy Impact Assessment: Yes.

    Nature and Extent of Confidentiality: In general, there is no need for confidentiality with this collection of information.

    Needs and Uses: FCC Form 601 is a consolidated, multi-part application form that is used for market-based and site-based licensing for wireless telecommunications services, including public safety licenses, which are filed through the Commission's Universal Licensing System (ULS). FCC Form 601 is composed of a main form that contains administrative information and a series of schedules used for filing technical and other information. This form is used to apply for a new license, to amend or withdraw a pending application, to modify or renew an existing license, cancel a license, request a duplicate license, submit required notifications, request an extension of time to satisfy construction requirements, or request an administrative update to an existing license (such as mailing address change), request a Special Temporary Authority or Developmental License. Respondents are encouraged to submit FCC Form 601 electronically and are required to do so when submitting FCC Form 601 to apply for an authorization for which the applicant was the winning bidder in a spectrum auction.

    The data collected on FCC Form 601 includes the FCC Registration Number (FRN), which serves as a “common link” for all filings an entity has with the FCC. The Debt Collection Improvement Act of 1996 requires entities filing with the Commission to use an FRN.

    On August 3, 2017, the Commission released the WRS Reform Second Report and Order in which it consolidated the hodgepodge of service-specific renewal and permanent discontinuance rules into consolidated Part 1 rules, 1.949 and 1.953, respectively (See Amendment of Parts 1, 22, 24, 27, 74, 80, 90, 95, and 101 To Establish Uniform License Renewal, Discontinuance of Operation, and Geographic Partitioning and Spectrum Disaggregation Rules and Policies for Certain Wireless Radio Services, Second Report and Order and Further Notice of Proposed Rulemaking, FCC 17-105, (WRS Reform Second Report and Order)). Of relevance to the information collection at issue here, the Commission established a consistent standard for renewing wireless licenses and set forth safe harbors providing expedited renewal for licensees that meet their initial term construction requirement and remain operating at or above that level. In addition, the Commission adopted consistent service continuity rules, which provide for automatic termination of any license on which a licensee permanently discontinues service or operation.

    The Commission now seeks approval for revisions to its currently approved collection of information under OMB Control Number 3060-0798 to permit (1) the collection of renewal-related information for Wireless Radio Service (WRS) licenses, and (2) the filing of requests to extend a permanent discontinuance period for good cause. Regarding renewal of WRS licenses, § 1.949(d) of the Commission's rules requires an applicant for renewal of certain WRS licenses to meet the Renewal Standard, i.e., the applicant must demonstrate that over the course of the license term, the licensee provided and continues to provide service to the public, or operated and continues to operate the license to meet the licensee(s)' private, internal communications needs. A renewal applicant can meet the Renewal Standard by certifying compliance with one of the safe harbors enumerated in § 1.949(e) of the Commission's rules, or, if the applicant cannot satisfy the requirements of one of the safe harbors, the applicant must make a Renewal Showing consistent with § 1.949(f). In addition, a renewal applicant must make a Regulatory Compliance Certification certifying that it has substantially complied with all applicable FCC rules, policies, and the Communications Act of 1934, as amended. If an applicant is unable to make this substantial compliance certification, it will need to provide an explanation of the circumstances preventing such a certification and why renewal of the subject license should still be granted.

    We do not anticipate that these revisions will have any impact on the burden to complete FCC Form 601. The renewal process remains virtually unchanged for site-based licensees, which will continue to have streamlined processes for renewal under the safe harbors adopted in the WRS Reform Second Report and Order. For licensees which had to make renewal showings under the Commissions' prior, service-specific renewal rules, including 700 MHz Commercial Services, 600 MHz Service, H-Block Service, AWS-3, AWS-4, and 218-219 MHz Service, the rules now provide for streamlined renewal processes under the safe harbor provisions in § 1.949(e), which minimize the burdens on such licensees. The Commission expects that most licensees will be able to avail themselves of the streamlined safe harbor process. Although some licensees will be required to make a renewal showing, on balance, we believe there will be no increase in the overall annual burden to complete the form. Further, the Commission's experience with requests to extend the discontinuance period for licensees in the cellular service leads us to anticipate few, if any, such requests will be filed under our new rules. Specifically, we are unaware of any requests to extend a cellular discontinuance period. Thus, we believe there will be a negligible, if any, impact on the annual burden to complete the form.

    The Commission therefore seeks approval for a revision to its currently approved information collection on FCC Form 601 to revise FCC Form 601 accordingly.

    OMB Control Number: 3060-0800.

    Title: FCC Application for Assignments of Authorization and Transfers of Control: Wireless Telecommunications Bureau and Public Safety and Homeland Security Bureau.

    Form Number: FCC Form 603.

    Type of Review: Revision of a currently approved collection.

    Respondents: Business or other for-profit entities, Individuals or households, not-for-profit institutions, and State, Local or Tribal Governments.

    Number of Respondents and Responses: 2,447 respondents; 2,447 responses.

    Estimated Time per Response: 0.5 hours-1.75 hours.

    Frequency of Response: Recordkeeping requirement, on occasion reporting requirement and periodic reporting requirement.

    Obligation to Respond: Required to obtain or retain benefits. The statutory authority for this collection is contained in 47 U.S.C. 154, 155, 158, 161, 301, 303(r), 308, 309, 310 and 332.

    Total Annual Burden: 2,759 hours.

    Annual Cost Burden: $366,975.

    Privacy Act Impact Assessment: Yes.

    Nature and Extent of Confidentiality: In general, there is no need for confidentiality with this collection of information.

    Needs and Uses: FCC Form 603 is a multi-purpose form that is used by radio services in Wireless Services within the Universal Licensing System (ULS). FCC 603 is composed of a main form that contains the administrative information and a series of schedules used for filing technical information. These schedules are required when applying for Auctioned Services, Partitioning and Disaggregation, Undefined Geographical Area Partitioning, and Notification of Consummation or Request for Extension of Time for Consummation. Applicants/licensees in the Public Mobile Services, Personal Communications Services, Private Land Mobile Radio Services, Broadband Radio Service, Educational Broadband Service, Maritime Services (excluding Ship), and Aviation Services (excluding Aircraft) use FCC Form 603 to apply for an assignment or transfer, to establish their parties' basic eligibility and qualifications, to classify the filing, and/or to determine the nature of the proposed service. This form is also used to notify the FCC of consummated assignments and transfers of wireless licenses to which the Commission has previously consented or for which notification but not prior consent is required. Respondents are encouraged to submit FCC 603 electronically.

    The data collected on FCC 603 include the FCC Registration Number (FRN), which serves as a “common link” for all filings an entity has with the FCC. The Debt Collection Improvement Act of 1996 required that those filing with the Commission to use an FRN, effective December 3, 2001.

    Records may include information about individuals or households, e.g., personally identifiable information or PII, and the use(s) and disclosure of this information are governed by the requirements of a system of records notice or `SORN', FCC/WTB-1, “Wireless Services Licensing Records.” There are no additional impacts under the Privacy Act.

    On August 3, 2017, the Commission released the WRS Reform Second Report and Order in which it consolidated the hodgepodge of service-specific geographic partitioning and spectrum disaggregation rules into a consolidated Part 1 rule, 1.950 (See Amendment of Parts 1, 22, 24, 27, 74, 80, 90, 95, and 101 To Establish Uniform License Renewal, Discontinuance of Operation, and Geographic Partitioning and Spectrum Disaggregation Rules and Policies for Certain Wireless Radio Services, Second Report and Order and Further Notice of Proposed Rulemaking, FCC 17-105, (WRS Reform Second Report and Order)). Of relevance to the information collection at issue here, the Commission required that when portions of geographic licenses are sold, both parties to the transaction have a clear construction obligation and penalty in the event of failure.

    Specifically, § 1.950(c) requires parties seeking approval for geographic partitioning, spectrum disaggregation, or a combination of both must apply for a partial assignment of authorization by filing FCC Form 603 pursuant to § 1.948 of the Commission's rules. Each request for geographic partitioning must include an attachment defining the perimeter of the partitioned area by geographic coordinates to the nearest second of latitude and longitude, based upon the 1983 North American Datum (NAD83). Alternatively, applicants may specify an FCC-recognized service area (e.g., Basic Trading Area, Economic Area, Major Trading Area, Metropolitan Service Area, or Rural Service Area), county, or county equivalent, in which case, applicants need only list the specific FCC-recognized service area, county, or county equivalent names comprising the partitioned area. Additionally, applicants have the option to submit geographic data associated with applications to partition and/or disaggregate their license using a shapefile, KML or Geojson file format.

    In addition, § 1.950(d) requires applicants for geographic partitioning, spectrum disaggregation, or a combination of both, to include, if applicable, a certification with their partial assignment of authorization application stating which party will meet any incumbent relocation requirements, except as otherwise stated in service-specific rules. Further, § 1.950(g) provides parties to geographic partitioning, spectrum disaggregation, or a combination of both, with two options to satisfy service-specific performance requirements (i.e., construction and operation requirements). Under the first option, each party may certify that it will individually satisfy any service-specific requirements and, upon failure, must individually face any service-specific performance penalties. Under the second option, both parties may agree to share responsibility for any service-specific requirements. Upon failure to meet their shared service-specific performance requirements, both parties will be subject to any service-specific penalties.

    The Commission seeks approval for revisions to its currently approved collection of information under OMB Control Number 3060-0800 to permit the collection of the additional information in connection with partial assignments of authorizations for geographic partitioning, spectrum disaggregation, or a combination of both, pursuant to the rules and information collection requirements adopted by the Commission in the WRS Reform Second Report and Order. We do not anticipate that these revisions will impact the collection filing burden.

    Federal Communications Commission. Marlene H. Dortch, Secretary, Office of the Secretary.
    [FR Doc. 2017-23627 Filed 10-30-17; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL COMMUNICATIONS COMMISSION Open Commission Meeting, Tuesday, October 24, 2017 October 17, 2017.

    The Federal Communications Commission will hold an Open Meeting on the subjects listed below on Tuesday, October 24, 2017 which is scheduled to commence at 10:30 a.m. in Room TW-C305, at 445 12th Street SW., Washington, DC.

    Item No. Bureau Subject 1 Consumer & Governmental Affairs Title: Rules and Policies Regarding Calling Number Identification Service—Caller ID (CC Docket No. 91-281) Summary: The Commission will consider a Report and Order that would enable law enforcement and security personnel to obtain quick access to blocked Caller ID information needed to investigate threatening calls. It also would amend the Commission's rules to allow non-public emergency services, such as private ambulance companies, to obtain blocked Caller ID information associated with calls requesting assistance. 2 Wireline Competition Title: Nationwide Number Portability (WC Docket No. 17-244); Numbering Policies for Modern Communications (WC Docket No. 13-97) Summary: The Commission will consider a Notice of Proposed Rulemaking and Notice of Inquiry that proposes to amend the Commission's rules as well as seeks comment on industry models to move toward complete nationwide number portability to promote competition between all service providers and increase network routing efficiencies. 3 Wireline Tele-Communications and Office of Engineering & Technology Title: Promoting Investment in the 3550-3700 MHz Band (GN Docket No. 17-258)
  • Summary: The Commission will consider a Notice of Proposed Rulemaking that would seek comment and propose changes to the Priority Access License rules in the 3550-3700 MHz (3.5 GHz) band to increase incentives for investment, encourage more efficient spectrum use, and promote faster and more widespread network deployments.
  • 4 Consumer & Governmental Affairs Title: Access to Telecommunications Equipment and Services by Persons with Disabilities (CG Docket No. 13-46); Amendment of the Commission's Rules Governing Hearing Aid-Compatible Mobile Handsets (WT Docket No. 07-250); Comment Sought on 2010 Review of Hearing Aid Compatibility Regulations (WT Docket No. 10-254) Summary: The Commission will consider a Report and Order and Order on Reconsideration on hearing aid compatibility (HAC) that would update the volume control standard for wireline telephones, extend wireline HAC requirements to cover telephones used with advanced communications services, adopt a volume control rule for wireless handsets, and delete from the Commission's rules an obsolete wireless HAC standard. 5 International Title: Section 43.62 Reporting Requirements for U.S. Providers of International Services (IB Docket No. 17-55); 2016 Biennial Review of Telecommunications Regulations (IB Docket No. 16-131) Summary: The Commission will consider a Report and Order that would: (1) Eliminate the Traffic and Revenue Reports and (2) streamline the Circuit Capacity Reports. 6 Media Title: Elimination of Main Studio Rule (MB Docket No. 17-106) Summary: The Commission will consider a Report and Order eliminating the rule that requires each AM, FM, and television broadcast station to maintain a main studio located in or near its community of license. 7 Media Title: Amendment of Section 73.624(g) of the Commission's Rules Regarding Submission of FCC Form 2100, Schedule G, Used to Report TV Stations' Ancillary or Supplementary Services, Amendment of Section 73.3580 of the Commission's Rules Regarding Public Notice of the Filing of Broadcast Applications (MB Docket No. 17-264); Modernization of Media Regulation Initiative (MB Docket No. 17-105); Revision of the Public Notice Requirements of Section 73.3580 (MB Docket 05-6) Summary: The Commission will consider a Notice of Proposed Rulemaking that seeks comment on updates to Section 73.624(g) of its rules, which imposes certain reporting obligations for broadcasters relating to the provision of ancillary or supplementary services, and Section 73.3580, which requires public notice of the filing of broadcast applications, including through newspapers.

    The meeting site is fully accessible to people using wheelchairs or other mobility aids. Sign language interpreters, open captioning, and assistive listening devices will be provided on site. Other reasonable accommodations for people with disabilities are available upon request. In your request, include a description of the accommodation you will need and a way we can contact you if we need more information. Last minute requests will be accepted, but may be impossible to fill. Send an email to: [email protected] or call the Consumer & Governmental Affairs Bureau at 202-418-0530 (voice), 202-418-0432 (TTY).

    Additional information concerning this meeting may be obtained from the Office of Media Relations, (202) 418-0500; TTY 1-888-835-5322. Audio/Video coverage of the meeting will be broadcast live with open captioning over the Internet from the FCC Live Web page at www.fcc.gov/live.

    For a fee this meeting can be viewed live over George Mason University's Capitol Connection. The Capitol Connection also will carry the meeting live via the Internet. To purchase these services, call (703) 993-3100 or go to www.capitolconnection.gmu.edu.

    Federal Communications Commission. Marlene H. Dortch, Secretary.
    [FR Doc. 2017-23628 Filed 10-30-17; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL COMMUNICATIONS COMMISSION [OMB 3060-1057] 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), 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 January 2, 2018. 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 No.: 3060-1057.

    Title: Application for Authority to Construct or Make Changes in an International Broadcast Station.

    Form No.: FCC Form 420-IB.

    Type of Review: Extension of a currently approved information collection.

    Respondents: Business or other for-profit.

    Number of Respondents: 10 respondents; 10 responses.

    Estimated Time per Response: 6 hours per response.

    Frequency of Response: On occasion reporting requirement.

    Obligation to Respond: Required to obtain or retain benefits. The statutory authority for this information collection is contained in 47 U.S.C. 154, 303, 334, 336 and 339.

    Total Annual Burden: 60 hours.

    Annual Cost Burden: $46,050.

    Privacy Act Impact Assessment: No impact(s).

    Nature and Extent of Confidentiality: In general, there is no need for confidentiality with this collection of information.

    Needs and Uses: This collection will be submitted to the Office of Management and Budget (OMB) as an extension following the 60-day comment period in order to obtain the full three-year clearance from OMB.

    The Federal Communications Commission (“Commission”) received approval from the OMB to develop a new application titled, “Application for Authority to Construct or Make Changes in an International Broadcast Station (FCC Form 420-IB)” to request authority from the Commission to construct or make changes in an international broadcast station. This application has not been implemented and released to the public yet due to a lack of budget resources and technical staff. After the FCC Form 420-IB has been implemented and the Commission has obtained final approval from the OMB, it will be completed by international broadcasters in lieu of the “Application for Authority to Construct or Make Changes in an International, Experimental Television, Experimental Facsimile, or a Developmental Broadcast Station,” (FCC Form 309). In the interim, applicants will continue to file the FCC Form 309 with the Commission. (Note: The OMB approved the FCC Form 309 under OMB Control No. 3060-1035.

    The information collected pursuant to the rules set forth in 47 CFR part 73, subpart F, is used by the Commission to assign frequencies for use by international broadcast stations, to grant authority to operate such stations and to determine if interference or adverse propagation conditions exist that may impact the operation of such stations. If the Commission did not collect this information, it would not be in a position to effectively coordinate spectrum for international broadcasters or to act for entities in times of frequency interference or adverse propagation conditions. The orderly nature of the provision of international broadcast service would be in jeopardy without the Commission's involvement.

    Federal Communications Commission. Marlene H. Dortch, Secretary, Office of the Secretary.
    [FR Doc. 2017-23626 Filed 10-30-17; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL RESERVE SYSTEM Formations of, Acquisitions by, and Mergers of Bank Holding Companies

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

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

    Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than November 28, 2017.

    A. Federal Reserve Bank of Atlanta (Kathryn Haney, Director of Applications) 1000 Peachtree Street NE., Atlanta, Georgia 30309. Comments can also be sent electronically to [email protected]:

    1. Southeastern Bancorp, Inc., Dickson, Tennessee, a savings and loan holding company; to become a bank holding company by acquiring voting shares of Cumberland Bancorp Inc., and thereby acquire shares of Cumberland Bank & Trust, both of Clarksville, Tennessee.

    In connection with this proposal, Southeastern Bancorp, Inc., Dickson, Tennessee has applied to retain ownership of its savings association subsidiary, First Federal Bank, Dickson, Tennessee, pursuant to section 225.28(b)(4)(ii) of Regulation Y.

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

    1. Bank Street Capital Corporation; to become a bank holding company by acquiring 100 percent of the voting shares of Waukesha State Bank, both of Waukesha, Wisconsin.

    Board of Governors of the Federal Reserve System, October 26, 2017. Ann E. Misback, Secretary of the Board.
    [FR Doc. 2017-23682 Filed 10-30-17; 8:45 am] BILLING CODE 6210-01-P
    FEDERAL RESERVE SYSTEM Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company

    The notificants listed below have applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and § 225.41 of the Board's Regulation Y (12 CFR 225.41) to acquire shares of a bank or bank holding company. The factors that are considered in acting on the notices are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)).

    The notices are available for immediate inspection at the Federal Reserve Bank indicated. The notices also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors. Comments must be received not later than November 16, 2017.

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

    1. Timothy Derwin Murphy, Atwood, Illinois; to join Boulevard Financial, L.P., a qualified limited family partnership, as a general partner and thereby acquire voting shares of TNB Bancorp, Inc., and indirectly acquire shares of TNB Bank, both of Tuscola, Illinois.

    Board of Governors of the Federal Reserve System, October 25, 2017. Ann E. Misback, Secretary of the Board.
    [FR Doc. 2017-23565 Filed 10-30-17; 8:45 am] BILLING CODE P
    FEDERAL RESERVE SYSTEM Formations of, Acquisitions by, and Mergers of Bank Holding Companies

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

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

    Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than November 27, 2017.

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

    1. Rigler Investment Company, New Hampton, Iowa; to acquire voting shares of Green Circle Investments, Inc., Clive, Iowa and thereby indirectly acquire shares of Peoples Trust and Savings Bank, Clive, Iowa.

    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. Arvest Bank Group, Inc., and Arvest Holdings, Inc., both of Bentonville, Arkansas; indirectly through its wholly owned subsidiary, Arvest Acquisition Sub, Inc., Fayetteville, Arkansas; to acquire 100 percent of the voting shares of Bear State Financial, Inc., and thereby indirectly acquire Bear State Bank, both of Little Rock, Arkansas.

    C. Federal Reserve Bank of Minneapolis (Brendan S. Murrin, Assistant Vice President) 90 Hennepin Avenue, Minneapolis, Minnesota 55480-0291:

    1. First Holding Company of Cavalier, Inc., Cavalier, North Dakota; to acquire 100 percent of the voting shares of First National Bank Mahnomen Twin Valley, Mahnomen, Minnesota.

    Board of Governors of the Federal Reserve System, October 25, 2017. Ann E. Misback, Secretary of the Board.
    [FR Doc. 2017-23564 Filed 10-30-17; 8:45 am] BILLING CODE 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 November 28, 2017.

    A. Federal Reserve Bank of Atlanta (Kathryn Haney, Director of Applications) 1000 Peachtree Street NE., Atlanta, Georgia 30309. Comments can also be sent electronically to [email protected]:

    1. Southeastern Bancorp, Inc., Dickson, Tennessee; to merge with Cumberland Bancorp Inc., and thereby acquire Cumberland Bank & Trust, both of Clarksville, Tennessee. Southeastern Bancorp, Inc. will retain ownership of its savings association subsidiary, First Federal Bank, Dickson, Tennessee, and thereby continue to engage in operating a savings association. Southeastern Bancorp, Inc. will convert back to a savings and loan holding company after the merger of Cumberland Bank & Trust with and into First Federal Bank.

    Board of Governors of the Federal Reserve System, October 26, 2017. Ann E. Misback, Secretary of the Board.
    [FR Doc. 2017-23681 Filed 10-30-17; 8:45 am] BILLING CODE P
    GENERAL SERVICES ADMINISTRATION [Notice-MV-2017-04; Docket No. 2017-0002; Sequence 19] Public Availability of General Services Administration Fiscal Year 2016 Service Contract Inventory AGENCY:

    Office of Governmentwide Policy; General Services Administration, (GSA).

    ACTION:

    Notice of public availability of GSA Fiscal Year 2016 Service Contract Inventories.

    SUMMARY:

    In accordance with The Fiscal Year (FY) 2010 Consolidated Appropriations Act, GSA is publishing this notice to advise the public of the availability of the FY 2016 Service Contract Inventories.

    DATES:

    October 31, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Questions regarding the Service Contract Inventory should be directed to Mr. James Tsujimoto in the Office of Acquisition Policy at 202-206-3585 or [email protected]

    SUPPLEMENTARY INFORMATION:

    In accordance with section 743 of Division C of the FY 2010 Consolidated Appropriations Act (Pub. L. 111-117), GSA is publishing this notice to advise the public of the availability of the FY 2016 Service Contract Inventories. These inventories are available at https://www.acquisition.gov/service-contract-inventory. The inventories provide information on governmentwide service contract actions over $25,000 that were made in FY 2016. The service contract inventory information located on acquisition.gov can be filtered by agency and component to show how contracted resources are distributed throughout any agency. The inventory has been developed in accordance with the guidance issued on December 19, 2011, by the Office of Management and Budget's Office of Federal Procurement Policy (OFPP). OFPP's guidance is available at: https://obamawhitehouse.archives.gov/omb/procurement-service-contract-inventories. GSA has posted its FY 2015 inventory analysis and its planned analysis of FY 2016 actions at the following location: http://www.gsa.gov/gsasci.

    Jeffrey A. Koses, Director, Office of Acquisition Policy, Office of Government-wide Policy.
    [FR Doc. 2017-23662 Filed 10-30-17; 8:45 am] BILLING CODE 6820-61-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [Docket No. CDC-2017-0019] Notice of Availability of the Final Environmental Assessment and Finding of No Significant Impact for HHS/CDC Chamblee Campus 2025 Master Plan, Chamblee, Georgia AGENCY:

    Centers for Disease Control and Prevention, Department of Health and Human Services (HHS).

    ACTION:

    Notice of Availability of the Final Environmental Assessment and Finding of No Significant Impact.

    SUMMARY:

    The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS) announces the availability of the Final Environmental Assessment (EA) and a Finding of No Significant Impact (FONSI) for the CDC Chamblee Campus 2025 Master Plan.

    FOR FURTHER INFORMATION CONTACT:

    Angela Wagner, Portfolio Manager, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-K96, Atlanta, Georgia 30329, Telephone: (770) 488-8170.

    SUPPLEMENTARY INFORMATION:

    On March 22, 2017 CDC announced the availability for public comment of a Draft Environmental Assessment (Draft EA) for the implementation of the CDC Chamblee Campus 2025 Master Plan (Master Plan) (82 FR 14733). CDC's Chamblee Campus is located at 4770 Buford Highway, Chamblee, Georgia. The Draft EA was available for a 60-day public comment period that ended on May 22, 2017. Six comments were received to the docket; none of the comments raised specific issues or concerns with the methodology, analysis, conclusion or accuracy of the EA.

    The Draft EA was prepared in accordance with the National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321 et seq.), the Council on Environmental Quality (CEQ) implementing regulations (40 CFR 1500-1508) and the HHS General Administration Manual (GAM) Part 30 Environmental Procedures, dated February 25, 2000. CDC has determined that the proposed action would not have a significant impact on the human or natural environment and therefore, the preparation of an Environmental Impact Statement is not required. Copies of the FONSI and/or Final EA are available by contacting Angela Wagner (please see FOR FURTHER INFORMATION CONTACT).

    The Chamblee Campus 2025 Master Plan provides a framework for future growth on the Chamblee Campus in order to ensure that the campus can support CDC's mission and to guide strategic decisions about the allocation of Federal resources. The Master Plan identifies a number of potential improvements that may be completed through the 2025 timeframe, and establishes design and planning guidelines.

    The proposed improvements include: (1) New building construction, including an approximately 386,000 gross square feet (gsf) office building, an approximately 415,000 gsf laboratory building and an adjacent approximately 10,000 gsf laboratory material handling facility; and a new, approximately 20,000 gsf, central utility plant (CUP); (2) building demolition; (3) expansion and reconfiguration of parking on campus; (4) installation of a comprehensive solar photovoltaic system; (5) improvements to the campus entrances; and (6) additional infrastructure improvements.

    CDC assessed the potential impacts of the proposed improvements on the natural and human environment and determined that the proposed action would not result in significant adverse impacts. Based on the results of the Final EA, CDC has issued a FONSI indicating the proposed action will not have a significant impact on the environment. The Build Alternative will be undertaken in accordance with the best management practices (BMPs), minimization and mitigation measures as presented in the Final EA and FONSI.

    Dated: October 25, 2017. Sandra Cashman, Executive Secretary, Centers for Disease Control and Prevention.
    [FR Doc. 2017-23668 Filed 10-30-17; 8:45 am] BILLING CODE 4163-18-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [Docket No. CDC-2017-0103] Request for Information on Effective, Large-Scale, Sustainable Approaches To Help People Quit Using Tobacco by Employing Evidence-Based Treatment Options AGENCY:

    Centers for Disease Control and Prevention, Department of Health and Human Services (HHS).

    ACTION:

    Request for information.

    SUMMARY:

    The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) is requesting information from the public to inform future activities regarding how to efficiently and cost effectively help people quit using tobacco using evidence-based treatment options.

    DATES:

    Written comments must be received on or by January 2, 2018.

    ADDRESSES:

    Submit comments by any one of the following methods:

    Internet: Electronic comments may be sent via http://www.regulations.gov, docket control number CDC-2017-0103. Please follow the directions on the site to submit comments; or

    Mail: Comments may also be sent by mail to the attention of Pamela Lemos, Office on Smoking and Health, Centers for Disease Control and Prevention, 4770 Buford Highway, Mail Stop F-79, Atlanta, GA 30341.

    All relevant comments will be posted without change to http://www.regulations.gov including any personal information provided.

    FOR FURTHER INFORMATION CONTACT:

    Pamela Lemos, Office on Smoking and Health, Centers for Disease Control and Prevention, 4770 Buford Highway, Atlanta, GA 30341; Telephone (770) 488-5709; Email: [email protected]

    SUPPLEMENTARY INFORMATION: Scope of Problem

    Cigarette smoking is the leading cause of premature death and disease in the United States, causing about 480,000 deaths each year and costing the country over $300 billion annually in health care spending and lost productivity.1 2 Helping tobacco users quit completely is the quickest approach to reducing tobacco-related disease, death, and costs.7 Quitting smoking has immediate and long-term health benefits.1 While quitting smoking at any age is beneficial, smokers who quit by the age of 35 to 44 years can prevent most of the risk of dying from a smoking-related disease.1 8

    Most cigarette smokers say that they want to quit, more than half try to quit each year, and almost three in five American adults who ever smoked have quit.3 Several treatments are proven effective in helping tobacco users quit, including individual, group, and telephone counseling and seven FDA-approved cessation medications.3 4 Receiving advice to quit and quitting assistance from health care providers also increases quit rates.4 5 The use of both counseling and medication when trying to quit is more effective than using either method alone.4 5 However, only one-third of smokers use counseling and/or medication when trying to quit, and only one in twenty smokers use both.3 While adult cigarette smoking rates have been declining overall for several decades, certain groups continue to smoke at high rates and face special challenges in quitting, including adults who live below the poverty level and adults with behavioral health conditions.6 Those with behavioral health conditions include adults with mental illness or substance abuse disorders. The Substance Abuse and Mental Health Services Administration's National Survey on Drug Use and Health (NSDUH) defines mental illness as any diagnosable mental, behavioral, or emotional disorder and defines substance use disorder as dependence or abuse of alcohol or illicit drugs.

    Many resources are available to help smokers connect with evidence-based treatments. Telephone quitlines exist in all states and other innovative and emerging resources are available such as web based platforms, texting, chat, and mobile apps. Many smokers, however, are unaware of these resources or have misconceptions about them.

    Approach

    CDC is seeking information from the public to inform future activities that could efficiently and cost effectively connect tobacco users with evidence-based treatment options to help them quit. We plan to use the information gathered to inform activities including, but not limited to, state tobacco control programming, national governmental and nongovernmental organization work, and other entities that work to make broadly available and sustainable connections between people who want to quit using tobacco and evidence-based cessation assistance.

    The goal of this effort is to ensure that all tobacco users who want help quitting are aware of and have ready access to evidence-based treatment options through channels that they are comfortable using, including but not limited to telephone quitlines. We will carefully review and consider all comments received to this request for information.

    CDC is specifically interested in receiving information on the following topics:

    (1) How can CDC leverage emerging technologies to deliver evidence-based cessation interventions through new and innovative platforms that have broad reach, especially among younger adults, those with low income, and adults with chronic and/or behavioral health conditions?

    (2) What are some innovative approaches to reduce the cost—in time, staffing, and funding—of providing effective cessation services to people who want to quit using tobacco?

    (3) How might standardization of quitline services achieve greater efficiency while also preserving state quitlines' “brands,” flexibility, and capacity for innovation?

    (4) What communication channels and communication strategies should CDC consider employing to ensure that both tobacco users, including those belonging to high-risk and disadvantaged populations, and health care providers are aware of and have access to evidence-based cessation resources?

    (5) What role should CDC, state and local health departments, not for profit institutions, traditional healthcare providers, and/or professional healthcare partner organizations, play in ensuring that high-risk populations (such as smokers living below the poverty level or those with behavioral health conditions) have access to tailored cessation services of appropriate intensity to help them successfully quit?

    (6) How can CDC support state and local health departments, traditional healthcare providers, not for profit health institutions, and professional healthcare partner organizations to ensure that evidence-based tobacco cessation interventions are integrated into primary and behavioral health care settings on a consistent and sustainable basis?

    (7) How can the public health sector most effectively maximize the impact of public and private insurance coverage of cessation treatments as part of efforts to ensure that all tobacco users have barrier-free access to these treatments?

    References 1. U.S. Department of Health and Human Services. The Health Consequences of Smoking—50 Years of Progress: A Report of the Surgeon General. Atlanta: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health, 2014. 2. Xu X, Bishop EE, Kennedy SM, Simpson SA, Pechacek TF. Annual Healthcare Spending Attributable to Cigarette Smoking: An Update. American Journal of Preventive Medicine 2014;48(3):326-33. 3. Babb S, Malarcher A, Schauer G, Asman K, Jamal A. Quitting Smoking Among Adults—United States, 2000-2015. MMWR Morb Mortal Wkly Rep 2017;65:1457-1464. 4. Siu AL; US Preventive Services Task Force. Behavioral and pharmacotherapy interventions for tobacco smoking cessation in adults, including pregnant women: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med 2015;163:622-34. 5. Fiore MC, Jaén CR, Baker TB, et al. Treating Tobacco Use and Dependence: 2008 Update—Clinical Practice Guidelines. Rockville (MD): U.S. Department of Health and Human Services, Public Health Service, Agency for Healthcare Research and Quality, 2008. 6. Jamal A, King BA, Neff LJ, Whitmill J, Babb SD, Graffunder CM. Current Cigarette Smoking Among Adults—United States, 2005-2015. MMWR Morb Mortal Wkly Rep 2016;65:1205-1211. 7. Institute of Medicine. Ending the Tobacco Problem: A Blueprint for the Nation. Washington: The National Academies Press, 2007. 8. Jha P, Ramasundarahettige C, Landsman V, Rostron B, Thun M, Anderson RN, McAfee T, Peto R. 21st-century hazards of smoking and benefits of cessation in the United States. New England Journal of Medicine 2013;368(4):341-50. Dated: October 25, 2017. Sandra Cashman, Executive Secretary, Centers for Disease Control and Prevention.
    [FR Doc. 2017-23669 Filed 10-30-17; 8:45 am] BILLING CODE 4163-18-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [CDC-2017-0048; Docket Number NIOSH-156-C] Final Immediately Dangerous to Life or Health (IDLH) Value Profiles AGENCY:

    National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).

    ACTION:

    Notice of availability.

    SUMMARY:

    NIOSH announces the availability of the following four Immediately Dangerous to Life or Health (IDLH) Value Profile documents: Acetonitrile [CAS No. 75-05-8], Chloroacetonitrile [CAS No. 107-14-2], Methacrylonitrile [CAS No. 126-98-7], and Nitrogen dioxide [CAS No. 10102-44-0].

    DATES:

    The final IDLH Value Profile documents were published on September 29, 2017.

    ADDRESSES:

    These documents may be obtained at the following link: https://www.cdc.gov/niosh/idlh/default.html.

    FOR FURTHER INFORMATION CONTACT:

    R. Todd Niemeier, MS, CIH, NIOSH, Education and Information Division (EID), Robert A. Taft Laboratories, 1090 Tusculum Ave., MS-C32, Cincinnati, OH 45226, phone 513/533-8166 (not a toll-free number), email: [email protected].

    SUPPLEMENTARY INFORMATION:

    On May 5, 2017, NIOSH published a request for public review in the Federal Register [82 FR 21239] on IDLH Value profiles. We did not receive public comments, but did receive peer and stakeholder comments. These comments received were reviewed and addressed where appropriate.

    Frank Hearl, Chief of Staff, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention.
    [FR Doc. 2017-23665 Filed 10-30-17; 8:45 am] BILLING CODE 4163-19-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-5897] Packaging, Storage, and Disposal Options To Enhance Opioid Safety—Exploring the Path Forward; Public Workshop; Request for Comments AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of public workshop; request for comments.

    SUMMARY:

    The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled “Packaging, Storage, and Disposal Options To Enhance Opioid Safety—Exploring the Path Forward.” The purpose of this 2-day public workshop is to host a scientific discussion with experts and seek input from interested stakeholders regarding the role of packaging, storage, and disposal options within the larger landscape of activities aimed at addressing abuse, misuse, or inappropriate access of prescription opioid drug products (opioids); guiding principles and considerations for the design of packaging, storage, and disposal options for opioids; integrating packaging, storage, and disposal options into existing health care and pharmacy systems, including both open and closed health care systems (e.g., a closed system such as the U.S. Department of Veterans Affairs); data needs and how to address challenges in assessing the impact of packaging, storage, and disposal options in both the premarket and postmarket settings; and ways in which FDA could encourage the development and assessment of packaging, storage, and disposal options for opioids that have the potential to enhance opioid safety.

    DATES:

    The public workshop will be held on December 11 and 12, 2017, from 8:30 a.m. to 5 p.m. Submit either electronic or written comments on this public workshop by February 12, 2018. See the SUPPLEMENTARY INFORMATION section for registration date and information.

    ADDRESSES:

    The public workshop will be held at the Sheraton Silver Spring Hotel, 8777 Georgia Ave., Silver Spring, MD 20910. The hotel's phone number is 301-589-0800.

    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 February 12, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of February 12, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

    Electronic Submissions

    Submit electronic comments in the following way:

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

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

    Written/Paper Submissions

    Submit written/paper submissions as follows:

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

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

    Instructions: All submissions received must include the Docket No. FDA-2017-N-5897 for “Packaging, Storage, and Disposal Options To Enhance Opioid Safety—Exploring the Path Forward.” 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:

    Irene Z. Chan, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4420, Silver Spring, MD 20993-0002, 301-796-3962, [email protected]; or Michelle Eby, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4422, Silver Spring, MD 20993-0002, 301-796-4714, [email protected]

    SUPPLEMENTARY INFORMATION: I. Background

    FDA is deeply concerned about the widespread epidemic of opioid abuse, dependence, and overdose in the United States. FDA believes packaging, storage, and disposal options have the potential to enhance the safety of legally prescribed opioids. The development of such options is an important component of a multi-pronged approach to addressing the current opioid epidemic.

    FDA is exploring a scientific framework that supports and encourages the development of packaging, storage, and disposal options that can reduce or deter misuse, abuse, or inappropriate access to opioids, while allowing for the safe use of opioids by patients who need them. FDA will need to define the specific problems that packaging, storage, and disposal options could most effectively address; the guiding scientific principles to consider for the design and evaluation of these options; and the types of data most useful for evaluating them.

    The Duke-Margolis Center for Health Policy previously convened an expert workshop on June 1, 2017, to begin examining the potential role of packaging, storage, and disposal options in enhancing opioid safety and deterring misuse, abuse, and inappropriate access. This workshop provided a forum for discussing (1) the role of packaging, storage, and disposal options in addressing factors that enable opioid abuse and misuse or inappropriate access; (2) the current range of existing packaging, storage, and disposal options; (3) approaches to evaluating the impact of packaging, storage, and disposal options on misuse and abuse or inappropriate access of opioids; and (4) considerations for integrating the use of packaging, storage, and disposal options into existing health care and pharmacy systems. Following the June 1, 2017, Duke-Margolis Center for Health Policy expert workshop, an issues paper was developed.1 While the expert workshop and subsequent issues paper were supported through a cooperative agreement with FDA, the views expressed in the accompanying documents are those of the participants in attendance of that expert workshop, and do not necessarily reflect the official positions and policies of the Department of Health and Human Services, or imply endorsements by the U.S. Government or other organizations.

    1https://healthpolicy.duke.edu/events/exploring-packaging-storage-and-disposal-solutions-enhance-opioid-safety.

    II. Topics for Discussion at the Public Workshop

    In this 2-day public workshop, FDA plans to explore the appropriate path forward by hosting a scientific discussion with experts and seeking input from interested stakeholders. Further discussion is needed regarding (1) the role of packaging, storage, and disposal options within the larger landscape of activities aimed at addressing opioid abuse, misuse, or inappropriate access; (2) guiding principles and considerations for the design of packaging, storage, and disposal options for opioids; (3) integrating packaging, storage, and disposal options into existing health care and pharmacy systems, including both open and closed health care systems (e.g., a closed system such as the U.S. Department of Veterans Affairs); (4) data needs and how to address challenges in assessing the impact of packaging, storage, and disposal options in both the premarket and postmarket settings; and (5) ways in which FDA could encourage the development and assessment of packaging, storage, and disposal options for opioids that have the potential to enhance opioid safety.

    Participants will include individuals from a broad set of Federal, State, and private and public stakeholders who are working on the challenges of improving pain management while addressing the opioid abuse epidemic. Public participation and comment is encouraged.

    III. Participating in the Public Workshop

    Registration: To register for the public workshop, “Packaging, Storage, and Disposal Options to Enhance Opioid Safety—Exploring the Path Forward,” please visit the following Web site to register: https://nakamotoevents.wufoo.com/forms/pads-task-force-public-meeting/. Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone.

    Registration is free and based on space availability, with priority given to early registrants. Persons interested in attending this public workshop must register by December 1, 2017, midnight Eastern Time. Early registration is recommended because seating is limited; therefore, FDA may limit the number of participants from each organization. Registrants will receive confirmation when they have been accepted. If time and space permit, onsite registration on the day of the public workshop will be provided beginning at 7:30 a.m. We will let registrants know if registration closes before the day of the public workshop.

    If you need special accommodations due to a disability, please contact Michelle Eby at [email protected] no later than December 4, 2017.

    Public Participation in Scientific Workshop: Time will be provided during the discussion of each agenda topic for audience participants to provide comments if desired. Comments should be specific to the discussion topic, and the time provided will be at the discretion of the session chair.

    Streaming Webcast of the Public Workshop: This public workshop will also be webcast. Additional information will be made available regarding accessing the webcast 2 days prior to the public workshop at https://www.fda.gov/Drugs/NewsEvents/ucm571797.htm.

    Transcripts: Please be advised that as soon as a transcript of the public workshop is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff (see ADDRESSES). A link to the transcript will also be available on the internet at https://www.fda.gov/Drugs/NewsEvents/ucm571797.htm.

    Dated: October 11, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
    [FR Doc. 2017-23535 Filed 10-30-17; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No FDA-2008-D-0610] Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA or the Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection in the guidance on “Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic.”

    DATES:

    Submit either electronic or written comments on the collection of information by January 2, 2018.

    ADDRESSES:

    You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before January 2, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of January 2, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

    Electronic Submissions

    Submit electronic comments in the following way:

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

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

    Written/Paper Submissions

    Submit written/paper submissions as follows:

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

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

    Instructions: All submissions received must include the Docket No. FDA-2008-D-0610 for “Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic.” Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

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

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

    FOR FURTHER INFORMATION CONTACT:

    Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, [email protected]

    SUPPLEMENTARY INFORMATION:

    Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

    With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

    Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic OMB Control Number 0910-0701—Extension

    This information collection supports the above captioned Agency guidance. The guidance includes recommendations for planning, notification, and documentation for firms that report postmarketing adverse events. The guidance recommends that each firm's pandemic influenza continuity of operations plan (COOP) include instructions for reporting adverse events, including a plan for the submission of stored reports that were not submitted within regulatory timeframes. The guidance explains that firms that are unable to fulfill normal adverse event reporting requirements during an influenza pandemic should: (1) Maintain documentation of the conditions that prevent them from meeting normal reporting requirements; (2) notify the appropriate FDA organizational unit responsible for adverse event reporting compliance when the conditions exist and when the reporting process is restored; and (3) maintain records to identify what reports have been stored.

    Based on the number of manufacturers that would be covered by the guidance, we estimate that approximately 5,000 firms will add the following to their COOP: (1) Instructions for reporting adverse events and (2) a plan for submitting stored reports that were not submitted within regulatory timeframes. We estimate that each firm will take approximately 50 hours to prepare the adverse event reporting plan for its COOP.

    We estimate that approximately 500 firms will be unable to fulfill normal adverse event reporting requirements because of conditions caused by an influenza pandemic and that these firms will notify the appropriate FDA organizational unit responsible for adverse event reporting compliance when the conditions exist. Although we do not anticipate such pandemic influenza conditions to occur every year, for purposes of the PRA, we estimate that each of these firms will notify FDA approximately once each year and that each notification will take approximately 8 hours to prepare and submit.

    Concerning the recommendation in the guidance that firms unable to fulfill normal adverse event reporting requirements maintain documentation of the conditions that prevent them from meeting these requirements and also maintain records to identify what adverse event reports have been stored and when the reporting process is restored, we estimate that approximately 500 firms will each need approximately 8 hours to maintain the documentation and that approximately 500 firms will each need approximately 8 hours to maintain the records.

    We therefore estimate the burden of the collection of information as follows:

    Table 1—Estimated Annual Reporting Burden 1 Type of reporting Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Total annual
  • responses
  • Average
  • burden per
  • response
  • Total hours
    Notify FDA when normal reporting is not feasible 500 1 500 8 4,000 1 There are no capital costs or operating and maintenance costs associated with this collection of information.
    Table 2—Estimated Annual Recordkeeping Burden 1 Type of recordkeeping Number of
  • recordkeepers
  • Number of
  • records per
  • recordkeeper
  • Total annual
  • records
  • Hours per
  • record
  • Total hours
    Add adverse event reporting plan to COOP 5,000 1 5,000 50 250,000 Maintain documentation of influenza pandemic conditions and resultant high absenteeism 500 1 500 8 4,000 Maintain records to identify what reports have been stored and when the reporting process was restored 500 1 500 8 4,000 Total 258,000 1 There are no capital costs or operating and maintenance costs associated with this collection of information.

    Based on our experience with the information collection we have retained our current burden estimate of 258,000 hours annually.

    Dated: October 26, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
    [FR Doc. 2017-23659 Filed 10-30-17; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-D-6113] E9(R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials; International Council for Harmonisation; Draft Guidance for Industry; Availability AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of availability.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance entitled “E9(R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials.” The draft guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The draft guidance clarifies, updates, and extends the earlier “E9 Statistical Principles for Clinical Trials” in two main areas. Concerning estimands, it provides a framework for discussion of how the aims of a trial relate to the proposed statistical analysis. Concerning sensitivity analysis, it discusses how to use additional analyses to address concerns about the validity of assumptions underlying the main analysis. The draft guidance is intended to better align the choice of statistical methods with questions of regulatory importance and to improve the reliability of decisions about and representations of the effects of medical products.

    DATES:

    Submit either electronic or written comments on the draft guidance by April 30, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.

    ADDRESSES:

    You may submit comments on any guidance at any time as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

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

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

    Written/Paper Submissions

    Submit written/paper submissions as follows:

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

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

    Instructions: All submissions received must include the Docket No. FDA-2017-D-6113 for “E9(R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials; International Council for Harmonisation; Guidance for Industry; Availability.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff office between 9 a.m. and 4 p.m., Monday through Friday.

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

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

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

    Submit written requests for single copies of this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002, or the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. The guidance may also be obtained by mail by calling CBER at 1-800-835-4709 or 240-402-8010. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document.

    FOR FURTHER INFORMATION CONTACT:

    Regarding the guidance: Thomas Permutt, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 21, Rm. 3614, Silver Spring, MD 20993-0002, 301-796-1271; or John Scott, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 1018, Silver Spring, MD 20993-0002, 240-402-8779.

    Regarding the ICH: Amanda Roache, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1176, Silver Spring, MD 20993-0002, 301-796-4548.

    SUPPLEMENTARY INFORMATION: I. Background

    In recent years, regulatory authorities and industry associations from around the world have participated in many important initiatives to promote international harmonization of regulatory requirements under the ICH. FDA has participated in several ICH meetings designed to enhance harmonization, and FDA is committed to seeking scientifically based harmonized technical procedures for pharmaceutical development. One of the goals of harmonization is to identify and reduce differences in technical requirements for drug development among regulatory agencies.

    ICH was established to provide an opportunity for harmonization initiatives to be developed with input from both regulatory and industry representatives. FDA also seeks input from consumer representatives and others. ICH is concerned with harmonization of technical requirements for the registration of pharmaceutical products for human use among regulators around the world. The six founding members of the ICH are the European Commission; the European Federation of Pharmaceutical Industries Associations; FDA; the Japanese Ministry of Health, Labour, and Welfare; the Japanese Pharmaceutical Manufacturers Association; and the Pharmaceutical Research and Manufacturers of America. The Standing Members of the ICH Association include Health Canada and Swissmedic. Any party eligible as a Member in accordance with the ICH Articles of Association can apply for membership in writing to the ICH Secretariat. The ICH Secretariat, which coordinates the preparation of documentation, operates as an international nonprofit organization and is funded by the Members of the ICH Association.

    The ICH Assembly is the overarching body of the Association and includes representatives from each of the ICH members and observers. The Assembly is responsible for the endorsement of draft guidelines and adoption of final guidelines. FDA publishes ICH guidelines as FDA guidance.

    In July 2017, the ICH Assembly endorsed the draft guideline entitled “E9(R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials” and agreed that the guidance should be made available for public comment. The draft guidance is the product of the Efficacy Expert Working Group of the ICH. Comments about this draft will be considered by FDA and the Efficacy Expert Working Group.

    The draft guidance provides guidance on aligning the choice of statistical methods with the goals of a clinical trial; on communicating the rationale for such choices to FDA; and on using sensitivity analysis to characterize the robustness of the conclusions to plausible deviations from the assumptions of the main analysis.

    This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on “E9(R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.

    II. Electronic Access

    Persons with access to the internet may obtain the document at https://www.regulations.gov, https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.

    Dated: October 26, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
    [FR Doc. 2017-23613 Filed 10-30-17; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration National Advisory Committee on Rural Health and Human Services AGENCY:

    Health Resources and Service Administration (HRSA), Department of Health and Human Services (HHS).

    ACTION:

    Notice of charter renewal.

    SUMMARY:

    HHS is hereby giving notice that the charter for the National Advisory Committee on Rural Health and Human Services (NACRHHS) has been renewed. The effective date of the renewed charter is October 31, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Paul Moore, Designate Federal Official, NACRHHS, HRSA, 5600 Fishers Lane, Room 17W41C, Rockville, Maryland 20857, telephone (301) 443-0835, fax (301) 443-2803 or by email at [email protected]

    SUPPLEMENTARY INFORMATION:

    NACRHHS provides advice to the Secretary concerning the provision and financing of health care and human services in rural areas. The current Committee was established under Section 222 of the Public Health Service Act, as amended, 42 U.S.C. 217a. In accordance with Public Law 92-463, it was chartered on October 30, 1987, has been renewed at appropriate intervals, and will operate until October 31, 2019. The Committee will continue to operate in accordance with the provisions of the Federal Advisory Committee Act (FACA).

    A copy of the NACRHHS charter is available on the NACRHHS Web site at https://www.hrsa.gov/advisorycommittees/rural/. A copy of the charter is also available on the FACA database that is maintained by the Committee Management Secretariat under the General Services Administration. The Web site for the FACA database is http://www.facadatabase.gov/.

    Amy McNulty, Acting Director, Division of the Executive Secretariat.
    [FR Doc. 2017-23562 Filed 10-30-17; 8:45 am] BILLING CODE 4165-15-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Office of the Director, National Institutes of Health; Notice of Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the Office of AIDS Research Advisory Council.

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

    The meeting will be closed to the public in accordance with the provisions set forth in section 552b(c)(9)(B), Title 5 U.S.C., as amended, for the review of recommendations for the HHS Treatment and Prevention Guidelines for medical care of people living with HIV in the United States. Recommendations made from the working group to the OARAC will include drug names, treatment regimens, and prevention modalities to be used for the clinical care of PLWHA. The Council may revise the draft guidelines and change the content or scope of treatment and prevention for HIV/AIDS as recommended in the final guidelines. Premature disclosure of draft guidelines in an open meeting could negatively impact health and safety due to the premature disclosure of information to medical providers and the public. Draft guidelines could be misunderstood and confuse medical providers and the public as to what is the current HHS guidelines for the treatment and prevention of HIV/AIDS, could lead to premature changes in treatment regimens and prevention modalities that affect the health and safety of PLWHA and the public.

    Name of Committee: Office of AIDS Research Advisory Council.

    Date: November 16, 2017.

    Open: 8:30 a.m. to 12:00 p.m.

    Agenda: OAR Director's Report, updates from the DHHS HIV Treatment and Prevention Guidelines, OAR Task Force on Cost Sharing, and plans for the Clinical Trials Networks from the National Institute of Allergy and Infectious Diseases.

    Place: National Institutes of Health, Room ID13, 5601 Fishers Lane, Bethesda, MD 20892.

    Closed: 12:30 p.m. to 1:00 p.m.

    Agenda: To evaluate and review recommendations for the HHS Treatment and Prevention Guidelines.

    Place: National Institutes of Health, Room ID13, 5601 Fishers Lane, Bethesda, MD 20892.

    Open: 1:00 p.m. to 4:30 p.m.

    Agenda: Update from the National Heart, Lung, and Blood Institute on the merger of the MACS and WIHS, and updates on HIV/AIDS Research Activities from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institute on Aging.

    Place: National Institutes of Health Room ID13, 5601 Fishers Lane, Bethesda, MD 20892.

    Contact Person: Elizabeth S. Church, Ph.D., Executive Secretary , Office of AIDS Research, DPCPSI, Office of the Director, 5601 Fishers Lane, Room 2E-60, Rockville, MD 20852-9830, 240-627-3201, [email protected].

    Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.

    Information is also available on the Institute's/Center's home page: www.oar.nih.gov, where an agenda and any additional information for the meeting will be posted when available.

    (Catalogue of Federal Domestic Assistance Program Nos. 93.14, Intramural Research Training Award; 93.22, Clinical Research Loan Repayment Program for Individuals from Disadvantaged Backgrounds; 93.232, Loan Repayment Program for Research Generally; 93.39, Academic Research Enhancement Award; 93.936, NIH Acquired Immunodeficiency Syndrome Research Loan Repayment Program; 93.187, Undergraduate Scholarship Program for Individuals from Disadvantaged Backgrounds, National Institutes of Health, HHS)
    Dated: October 26, 2017. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2017-23641 Filed 10-30-17; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings

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

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

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Language and Cognition.

    Date: November 17, 2017.

    Time: 11:00 a.m. to 2:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call).

    Contact Person: Samantha Smith, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3170, Bethesda, MD 20892, 301-827-5491, [email protected].

    This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: AIDS and AIDS Related Research.

    Date: November 22, 2017.

    Time: 12:00 p.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications and/or proposals.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call).

    Contact Person: Jose H. Guerrier, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5218, MSC 7852, Bethesda, MD 20892, 301-435-1137, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR-17-144: Limited Competition: National Primate Research Centers (P51).

    Date: November 28-30, 2017.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Embassy Suites by Hilton Sacramento Riverfront, 100 Capitol Mall, Sacramento, CA 95814.

    Contact Person: Maribeth Champoux, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3170, MSC 7848, Bethesda, MD 20892, 301-594-3163, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Lasker Clinical Research Scholars Program.

    Date: November 28, 2017.

    Time: 1:00 p.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call).

    Contact Person: Abdelouahab Aitouche, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4222, MSC 7814, Bethesda, MD 20892, 301-435-2365, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Fellowships: Cancer Immunology and Immunotherapy.

    Date: November 29, 2017.

    Time: 10:00 a.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).

    Contact Person: Charles Selden, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5187, MSC 7840, Bethesda, MD 20892, 301-451-3388, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Interdisciplinary Molecular Sciences and Training.

    Date: November 29, 2017.

    Time: 11:00 a.m. to 2:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call).

    Contact Person: Alexander Gubin, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6046B, MSC 7892, Bethesda, MD 20892, 301-408-9655, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Retinopathies and Viral Eye Infections.

    Date: November 29, 2017.

    Time: 11:45 a.m. to 4:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call).

    Contact Person: Alessandra C. Rovescalli, Ph.D., Scientific Review Officer, National Institutes of Health, Center for Scientific Review, 6701 Rockledge Drive, Rm 5205 MSC7846, Bethesda, MD 20892, (301) 435-1021, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis Panel; APOE2 and Alzheimer's Disease.

    Date: November 29, 2017.

    Time: 1:00 p.m. to 3:30 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call).

    Contact Person: Carol Hamelink, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4192, MSC 7850, Bethesda, MD 20892, (301) 213-9887, [email protected].

    (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893, National Institutes of Health, HHS)
    Dated: October 25, 2017. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2017-23637 Filed 10-30-17; 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; NIAID Clinical Trial Implementation Grant (R01).

    Date: November 20, 2017.

    Time: 11:00 a.m. to 1:00 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: Jay R. Radke, Ph.D., Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, Room #3G11B, National Institutes of Health, NIAID, 5601 Fishers Lane MSC-9823, Bethesda, MD 20892-9823, (240) 669-5046, [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: October 25, 2017. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2017-23640 Filed 10-30-17; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings

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

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

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Small Business: Musculoskeletal Rehabilitation Sciences.

    Date: December 1, 2017.

    Time: 10:00 a.m. to 4:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892.

    Contact Person: Maria Nurminskaya, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, Bethesda, MD 20892, (301) 435-1222, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Neurodevelopment.

    Date: December 1, 2017.

    Time: 12:00 p.m. to 3:00 p.m.

    Agenda: To review and evaluate grant applications

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call).

    Contact Person: Afia Sultana, Ph.D., Scientific Review Officer, National Institutes of Health, Center for Scientific Review, 6701 Rockledge Drive, Room 4189, Bethesda, MD 20892, (301) 827-7083, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Cancer Health Disparities PAR Review.

    Date: December 4-5, 2017.

    Time: 8:00 a.m. to 4:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Embassy Suites at the Chevy Chase Pavilion, 4300 Military Road NW., Washington, DC 20015.

    Contact Person: Ola Mae Zack Howard, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4192, MSC 7806, Bethesda, MD 20892, 301-451-4467, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Topics in Virology.

    Date: December 4, 2017.

    Time: 10:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).

    Contact Person: Neerja Kaushik-Basu, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3198, MSC 7808, Bethesda, MD 20892, (301)435-2306, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Topics in Virology.

    Date: December 4, 2017.

    Time: 10:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).

    Contact Person: Susan Daum, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Dr., Room 3202, Bethesda, MD 20892, 301-827-7233, [email protected].

    (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893, National Institutes of Health, HHS)
    Dated: October 26, 2017. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2017-23639 Filed 10-30-17; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings

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

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

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Infectious Diseases, Reproductive Health, Asthma and Pulmonary Conditions: Small Grant Mechanisms.

    Date: November 14, 2017.

    Time: 8:30 a.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).

    Contact Person: Lisa Steele, Ph.D., Scientific Review Officer, PSE IRG, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3139, MSC 7770, Bethesda, MD 20892, 301-594-6594,