Federal Register Vol. 82, No.221,

Federal Register Volume 82, Issue 221 (November 17, 2017)

Page Range54289-55026
FR Document

82_FR_221
Current View
Page and SubjectPDF
82 FR 55025 - Commemoration of the 50th Anniversary of the Vietnam WarPDF
82 FR 54420 - Sunshine Act Meeting of the National Museum and Library Services BoardPDF
82 FR 54390 - Notice of Proposed Draft Program Comment To Exempt Effects of Transportation-Related Undertakings Within Rail Rights-of-WayPDF
82 FR 54404 - Revocation of Orders of Succession for the Office of the Deputy SecretaryPDF
82 FR 54339 - Adequacy Status of Motor Vehicle Emissions Budgets in Submitted Reasonable Further Progress Plan for San Diego 8-Hour Ozone for Transportation Conformity Purposes; CaliforniaPDF
82 FR 54309 - Approval of California Air Plan Revisions, Mojave Desert Air Quality Management DistrictPDF
82 FR 54307 - Approval of California Air Plan Revisions, Mojave Desert Air Quality Management DistrictPDF
82 FR 54409 - Notice of Availability of the Record of Decision for the Boardman to Hemingway Transmission Line Project and Approved Land-use Plan Amendments, OregonPDF
82 FR 54415 - Meeting of the Labor Advisory Committee for Trade Negotiation and Trade PolicyPDF
82 FR 54361 - Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection of Zika Virus; AvailabilityPDF
82 FR 54469 - Advisory Committee: National Academic Affiliations Council, Notice of MeetingPDF
82 FR 54344 - Agency Information Collection Activities: Submission for OMB Review; Comment RequestPDF
82 FR 54341 - Petition of COSCO Shipping Lines Co., Ltd., Orient Overseas Container Line Limited, and OOCL (Europe) Limited for an Exemption From Agreement Filing; Notice of Filing And Request for CommentsPDF
82 FR 54414 - Agency Information Collection Activities; Comment Request; Workforce Flexibility (Workflex) Plan Submission and Reporting RequirementsPDF
82 FR 54418 - Information Collection Activities; Comment RequestPDF
82 FR 54416 - Information Collection Activities; Comment RequestPDF
82 FR 54419 - Proposed Extension of Information Collection; Permissible Equipment TestingPDF
82 FR 54416 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Hazard Communication StandardPDF
82 FR 54420 - Advisory Committee for Integrative Activities: Notice of MeetingPDF
82 FR 54387 - Unique Device Identification: Direct Marking of Devices; Guidance for Industry and Food and Drug Administration Staff; AvailabilityPDF
82 FR 54335 - Proposed Information Collection; Comment Request; Alaska Commercial Operator's Annual Report (COAR)PDF
82 FR 54330 - Submission for OMB Review; Comment RequestPDF
82 FR 54332 - Submission for OMB Review; Comment RequestPDF
82 FR 54338 - Combined Notice of FilingsPDF
82 FR 54421 - Information Collection: Licenses and Radiation Safety Requirements for IrradiatorsPDF
82 FR 54465 - Projects Rescinded for Consumptive Uses of WaterPDF
82 FR 54464 - Projects Approved for Consumptive Uses of WaterPDF
82 FR 54464 - Projects Approved for Minor ModificationsPDF
82 FR 54465 - Hazardous Materials: Proposed Termination of M-Number and R-Number Approvals Issued Without an Expiration DatePDF
82 FR 54412 - Tin- and Chromium-Coated Steel Sheet From JapanPDF
82 FR 54340 - Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service DeliveryPDF
82 FR 54337 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Gainful Employment Program-Subpart R-Cohort Default RatesPDF
82 FR 54336 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Gainful Employment Program-Subpart Q-Appeals for Debt to Earnings RatesPDF
82 FR 54335 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Gainful Employment Programs-Subpart QPDF
82 FR 54405 - Issuance of Import Permits for Zimbabwe Elephant Trophies Taken on or After January 21, 2016, and on or Before December 31, 2018PDF
82 FR 54340 - Environmental Impact Statements; Notice of AvailabilityPDF
82 FR 54320 - Foreign-Trade Zone (FTZ) 52-Suffolk County, New York; Notification of Proposed Production Activity; Estee Lauder Inc., (Hair Straightening Styling Balm), Melville, New YorkPDF
82 FR 54338 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; SmartWay Transport Partnership (Renewal)PDF
82 FR 54403 - Alabama; Amendment No. 1 to Notice of an Emergency DeclarationPDF
82 FR 54402 - Technical Mapping Advisory CouncilPDF
82 FR 54402 - Agency Information Collection Activities: Proposed Collection; Comment Request; Revisions to National Flood Insurance Program Maps: Application Forms and Instructions for (C)LOMAs and (C)LOMR-FsPDF
82 FR 54320 - Certain Steel Nails From the Socialist Republic of Vietnam: Notice of Rescission of Countervailing Duty Administrative Review, 2016PDF
82 FR 54325 - Narrow Woven Ribbon With Woven Selvedge From the People's Republic of China: Final Results of Antidumping Duty Administrative Review; 2015-2016PDF
82 FR 54322 - Light-Walled Rectangular Pipe and Tube From Mexico: Initiation and Expedited Preliminary Results of Changed Circumstances ReviewPDF
82 FR 54324 - Steel Wire Garment Hangers From the People's Republic of China: Final Results of Antidumping Duty Administrative Review; 2015-2016PDF
82 FR 54463 - Determination Under Section 7070(c)(1) of the Department of State, Foreign Operations, and Related Programs Appropriations Act, 2017 Regarding the Central Government of NicaraguaPDF
82 FR 54332 - North Pacific Fishery Management Council; Public MeetingPDF
82 FR 54329 - New England Fishery Management Council; Public MeetingPDF
82 FR 54326 - Western Pacific Fishery Management Council; Public MeetingPDF
82 FR 54333 - New England Fishery Management Council; Public MeetingPDF
82 FR 54331 - Caribbean Fishery Management Council; Public MeetingPDF
82 FR 54331 - New England Fishery Management Council; Public MeetingPDF
82 FR 54334 - Mid-Atlantic Fishery Management Council (MAFMC); MeetingPDF
82 FR 54327 - South Atlantic Fishery Management Council; Public MeetingsPDF
82 FR 54466 - Notice of OFAC Sanctions ActionsPDF
82 FR 54314 - Possession, Use, and Transfer of Select Agents and Toxins; Addition of Certain Influenza Virus Strains to the List of Select Agents and ToxinsPDF
82 FR 54314 - Foreign Quarantine Regulations, Proposed Revision of HHS/CDC Animal Importation RegulationsPDF
82 FR 54315 - Total Inward Leakage Requirements for RespiratorsPDF
82 FR 54295 - VA Vocational Rehabilitation and Employment Nomenclature Change for Position Title-RevisionPDF
82 FR 54386 - Controlled Correspondence Related to Generic Drug Development; Draft Guidance for Industry; Availability; CorrectionPDF
82 FR 54467 - Notice of OFAC Sanctions ActionsPDF
82 FR 54334 - Endangered Species; File Nos. 20590 and 20610PDF
82 FR 54422 - Proposed Collection; Comment RequestPDF
82 FR 54301 - Television Broadcasting Services; Anchorage, AlaskaPDF
82 FR 54317 - Proposed Information Collection; Comment Request; American Community Survey Methods Panel TestsPDF
82 FR 54307 - Anchorages; Captain of the Port Puget Sound Zone, WAPDF
82 FR 54337 - Agency Information Collection Activities; Comment Request; Freedom of Information Act (FOIA) Third Party Perjury FormPDF
82 FR 54316 - Submission for OMB Review; Comment RequestPDF
82 FR 54439 - In the Matter of the Petitions of: Virtu Financial Inc. and Virtu Americas, LLC and Susquehanna International Group, et al.; Order Granting Motion To Substitute Parties and Motion for Extension of Time; Securities Exchange Act of 1934PDF
82 FR 54434 - Self-Regulatory Organizations; NYSEArca, Inc.; Notice of Filing of Amendment No. 3, and Order Granting Accelerated Approval of a Proposed Rule Change, as Modified by Amendment No. 3, To Amend NYSE Arca Rule 8.700-E and To List and Trade Shares of the ProShares European Volatility Futures ETFPDF
82 FR 54437 - Self-Regulatory Organizations; The Nasdaq Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend the Exchange's Fees at Rule 7036 To Withdraw the Nasdaq Market Analytics Data Package From SalePDF
82 FR 54442 - Self-Regulatory Organizations; Cboe EDGX Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Modify Its Fees for Physical Ports as They Relate to the Exchange's Equity Options PlatformPDF
82 FR 54423 - Self-Regulatory Organizations; ICE Clear Europe Limited; Notice of Filing of Proposed Rule Change, Security Based Swap Submission, or Advance Notice Relating to Amendments to the ICE Clear Europe Collateral and Haircut PolicyPDF
82 FR 54457 - Self-Regulatory Organizations; The Nasdaq Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend Rule 7014PDF
82 FR 54440 - Self-Regulatory Organizations; Cboe EDGA Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Modify Its Fees for Physical PortsPDF
82 FR 54453 - Self-Regulatory Organizations; Cboe EDGX Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Modify Its Fees for Physical PortsPDF
82 FR 54460 - Self-Regulatory Organizations; Nasdaq BX, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend the Exchange's Options Pricing at Chapter XV, Section 2PDF
82 FR 54425 - Self-Regulatory Organizations: Investors Exchange LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Adopt Rules Pertaining to Certain Listing Regulatory Reporting and Operational RequirementsPDF
82 FR 54443 - Self-Regulatory Organizations; Cboe EDGX Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Adopt Fees for Its Recently Adopted Functionality for the Handling of Complex Orders on Its Equity Options PlatformPDF
82 FR 54455 - Self-Regulatory Organizations; Municipal Securities Rulemaking Board; Notice of Filing of Amendment No. 1 to Proposed Rule Change To Amend MSRB Rule G-34, on CUSIP Numbers, New Issue, and Market Information RequirementsPDF
82 FR 54413 - Certain Mobile Device Holders and Components Thereof; Commission's Determination To Review In-Part a Final Initial Determination Finding a Violation of Section 337; Request for Written SubmissionsPDF
82 FR 54357 - Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry, Researchers, Patient Groups, and Food and Drug Administration Staff on Meetings With the Office of Orphan Products DevelopmentPDF
82 FR 54355 - Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Notification for a New Dietary IngredientPDF
82 FR 54351 - Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative Data on Tobacco Products and CommunicationsPDF
82 FR 54359 - Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration Recall RegulationsPDF
82 FR 54348 - Cardiac Troponin Assays; Public Workshop; Request for Comments; Extension of Comment PeriodPDF
82 FR 54411 - Notice of Receipt of Complaint; Solicitation of Comments Relating to the Public InterestPDF
82 FR 54430 - Self-Regulatory Organizations; The Options Clearing Corporation; Notice of Filing of Advance Notice Concerning Liquidity for Same-Day SettlementPDF
82 FR 54448 - Self-Regulatory Organizations; The Options Clearing Corporation; Notice of Filing of Advance Notice Concerning the Use of the Society of Worldwide Interbank Financial Telecommunication Messaging Network in OCC's Cash Settlement ProcessPDF
82 FR 54353 - Medical Gas Regulation; Public Workshops; Request for CommentsPDF
82 FR 54404 - Aviation Security Advisory Committee (ASAC) MeetingPDF
82 FR 54463 - Presidential Declaration Amendment of a Major Disaster for the Commonwealth of Puerto RicoPDF
82 FR 54342 - Agency Information Collection Activities; Submission for OMB Review; Comment RequestPDF
82 FR 54316 - Black Hills National Forest Advisory BoardPDF
82 FR 54422 - New Postal ProductsPDF
82 FR 54348 - Proposed Information Collection Activity: Comment RequestPDF
82 FR 54420 - Public Availability of the Merit Systems Protection Board FY 2015 Service Contract InventoryPDF
82 FR 54300 - Approval of Implementation Plans; State of Iowa; Elements of the Infrastructure SIP Requirements for the 2010 Sulfur Dioxide National Ambient Air Quality Standard (NAAQS); WithdrawalPDF
82 FR 54345 - Proposed Information Collection Activity; Comment RequestPDF
82 FR 54346 - Submission for OMB Review; Comment RequestPDF
82 FR 54463 - CSX Transportation, Inc.-Discontinuance of Service Exemption-in Dickenson County, VAPDF
82 FR 54388 - National Institute of Mental Health; Notice of Closed MeetingPDF
82 FR 54389 - National Institute on Alcohol Abuse and Alcoholism; Notice of Closed MeetingPDF
82 FR 54388 - National Heart, Lung, and Blood Institute; Notice of Closed MeetingPDF
82 FR 54389 - National Heart, Lung, and Blood Institute; Notice of Closed MeetingsPDF
82 FR 54389 - National Cancer Institute; Notice of Closed MeetingPDF
82 FR 54300 - Approval of Kansas Air Quality State Implementation Plans; Construction Permits and Approvals Program; WithdrawalPDF
82 FR 54299 - Air Quality Implementation Plans; Nebraska; Infrastructure SIP Requirements for the 2010 Nitrogen Dioxide and Sulfur Dioxide and the 2012 Fine Particulate Matter National Ambient Air Quality Standards; WithdrawalPDF
82 FR 54299 - State of Iowa; Elements of the Infrastructure SIP Requirements for the 2010 Nitrogen Dioxide National Ambient Air Quality Standard (NAAQS) WithdrawalPDF
82 FR 54300 - Approval and Promulgation of Air Quality Implementation Plans; Maryland; Direct Final Rule for the Approval of an Alternative Volatile Organic Compound Emission Standard; WithdrawalPDF
82 FR 54298 - Approval and Promulgation of Air Quality Implementation Plans; Maryland; 2011 Base Year Inventory for the 2008 8-Hour Ozone National Ambient Air Quality Standard for the Maryland Portion of the Philadelphia-Wilmington-Atlantic City Nonattainment Area; WithdrawalPDF
82 FR 54390 - Notice of Meeting for the Interdepartmental Serious Mental Illness Coordinating Committee (ISMICC)PDF
82 FR 54289 - Same Surgical Procedure Exception: Questions and Answers Regarding the Scope of the Exception; Guidance for Industry; AvailabilityPDF
82 FR 54290 - Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use; Guidance for Industry and Food and Drug Administration Staff; AvailabilityPDF
82 FR 54385 - Expedited Programs for Regenerative Medicine Therapies for Serious Conditions; Draft Guidance for Industry; AvailabilityPDF
82 FR 54349 - Evaluation of Devices Used With Regenerative Medicine Advanced Therapies; Draft Guidance for Industry; AvailabilityPDF
82 FR 54408 - Notice of Availability of the Draft Ray Land Exchange/Plan Amendment Supplemental Environmental Impact Statement, ArizonaPDF
82 FR 54304 - Airworthiness Directives; Bombardier, Inc., AirplanesPDF
82 FR 54302 - Airworthiness Directives; The Boeing Company AirplanesPDF
82 FR 54292 - Texas Regulatory ProgramPDF
82 FR 54321 - Notice of Meeting: Summit on Trade-Related Standards IssuesPDF
82 FR 54924 - Congressional Nullification of the Stream Protection Rule Under the Congressional Review ActPDF
82 FR 54472 - Payday, Vehicle Title, and Certain High-Cost Installment LoansPDF

Issue

82 221 Friday, November 17, 2017 Contents Agriculture Agriculture Department See

Forest Service

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 54316 2017-24940
Consumer Financial Protection Bureau of Consumer Financial Protection RULES Payday, Vehicle Title, and Certain High-Cost Installment Loans, 54472-54921 2017-21808 Census Bureau Census Bureau NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: American Community Survey Methods Panel Tests, 54317-54320 2017-24943 Centers Medicare Centers for Medicare & Medicaid Services NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 54344-54345 2017-25008 Children Children and Families Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Community Services Block Grant State Plan Application, 54348 2017-24905 Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery, 54345-54346 2017-24902 Variations in Implementation of Quality Interventions Project, 54346-54348 2017-24901 Coast Guard Coast Guard PROPOSED RULES Anchorage Areas: Captain of the Port Puget Sound Zone, WA; Withdrawal, 54307 2017-24942 Commerce Commerce Department See

Census Bureau

See

Foreign-Trade Zones Board

See

International Trade Administration

See

National Oceanic and Atmospheric Administration

Education Department Education Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Freedom of Information Act Third Party Perjury Form, 54337-54338 2017-24941 Gainful Employment Program—Subpart R—Cohort Default Rates, 54337 2017-24978 Gainful Employment Program—Subpart Q—Appeals for Debt to Earnings Rates, 54336-54337 2017-24977 Gainful Employment Programs—Subpart Q, 54335-54336 2017-24976 Employment and Training Employment and Training Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Workforce Flexibility Plan Submission and Reporting Requirements, 54414-54415 2017-24998 Energy Department Energy Department See

Federal Energy Regulatory Commission

Environmental Protection Environmental Protection Agency RULES Air Quality State Implementation Plans; Approvals and Promulgations: Iowa; Elements of the Infrastructure SIP Requirements for the 2010 Nitrogen Dioxide National Ambient Air Quality Standard; Withdrawal, 54299 2017-24891 Iowa; Elements of the Infrastructure SIP Requirements for the 2010 Sulfur Dioxide National Ambient Air Quality Standard; Withdrawal, 54300 2017-24903 Kansas; Construction Permits and Approvals Program; Withdrawal, 54300 2017-24894 Maryland; 2011 Base Year Inventory for the 2008 8-Hour Ozone National Ambient Air Quality Standard for the Maryland Portion of the Philadelphia-Wilmington-Atlantic City Nonattainment Area; Withdrawal, 54298-54299 2017-24885 Maryland; Direct Final Rule for the Approval of an Alternative Volatile Organic Compound Emission Standard; Withdrawal, 54300-54301 2017-24889 Nebraska; Infrastructure SIP Requirements for the 2010 Nitrogen Dioxide and Sulfur Dioxide and the 2012 Fine Particulate Matter National Ambient Air Quality Standards; Withdrawal, 54299 2017-24893 PROPOSED RULES Air Quality State Implementation Plans; Approvals and Promulgations: California Air Plan Revisions, Mojave Desert Air Quality Management District, 54307-54314 2017-25015 2017-25017 NOTICES Adequacy Status: Motor Vehicle Emissions Budgets in Submitted Reasonable Further Progress Plan for San Diego 8-hour Ozone for Transportation Conformity Purposes; California, 54339-54340 2017-25020 Agency Information Collection Activities; Proposals, Submissions, and Approvals: SmartWay Transport Partnership, 54338-54339 2017-24971 Environmental Impact Statements; Availability, etc., 54340 2017-24973 Equal Equal Employment Opportunity Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 54340-54341 2017-24979 Federal Aviation Federal Aviation Administration PROPOSED RULES Airworthiness Directives: Bombardier, Inc., Airplanes, 54304-54306 2017-24814 The Boeing Company Airplanes, 54302-54304 2017-24809 Federal Communications Federal Communications Commission RULES Television Broadcasting Services: Anchorage, AK, 54301 2017-24944 Federal Emergency Federal Emergency Management Agency NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Revisions to National Flood Insurance Program Maps: Application Forms and Instructions for (C)LOMAs and (C)LOMR-Fs, 54402-54403 2017-24968 Disaster Declarations: Alabama; Amendment 1, 54403-54404 2017-24970 Meetings: Technical Mapping Advisory Council, 54402 2017-24969 Federal Energy Federal Energy Regulatory Commission NOTICES Combined Filings, 54338 2017-24988 Federal Maritime Federal Maritime Commission NOTICES Petitions for Exemptions: COSCO Shipping Lines Co., Ltd., Orient Overseas Container Line Limited, and OOCL (Europe) Limited, 54341-54342 2017-25007 Federal Trade Federal Trade Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 54342-54344 2017-24915 Fish Fish and Wildlife Service NOTICES Import Permits: Zimbabwe Elephant Trophies Taken On or After January 21, 2016, and On or Before December 31, 2018, 54405-54408 2017-24974 Food and Drug Food and Drug Administration RULES Guidance: Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use, 54290-54292 2017-24838 Same Surgical Procedure Exception: Questions and Answers Regarding the Scope of the Exception, 54289-54290 2017-24839 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Food and Drug Administration Recall Regulations, 54359-54361 2017-24923 Generic Clearance for the Collection of Qualitative Data on Tobacco Products and Communications, 54351-54353 2017-24924 Guidance for Industry, Researchers, Patient Groups, and Food and Drug Administration Staff on Meetings With the Office of Orphan Products Development, 54357-54359 2017-24926 Premarket Notification for a New Dietary Ingredient, 54355-54357 2017-24925 Emergency Use Authorizations: In Vitro Diagnostic Devices for Detection of Zika Virus, 54361-54385 2017-25010 Guidance: Controlled Correspondence Related to Generic Drug Development; Correction, 54386-54387 2017-24948 Evaluation of Devices Used With Regenerative Medicine Advanced Therapies, 54349-54351 2017-24836 Expedited Programs for Regenerative Medicine Therapies for Serious Conditions, 54385-54386 2017-24837 Unique Device Identification: Direct Marking of Devices, 54387-54388 2017-24992 Meetings: Cardiac Troponin Assays; Public Workshop, 54348-54349 2017-24922 Medical Gas Regulation; Public Workshops, 54353-54355 2017-24918 Foreign Assets Foreign Assets Control Office NOTICES Blocking or Unblocking of Persons and Properties, 54466-54469 2017-24947 2017-24954 Foreign Trade Foreign-Trade Zones Board NOTICES Proposed Production Activities: Estee Lauder Inc., Foreign-Trade Zone 52, Suffolk County, NY, 54320 2017-24972 Forest Forest Service NOTICES Meetings: Black Hills National Forest Advisory Board, 54316-54317 2017-24914 Health and Human Health and Human Services Department See

Centers for Medicare & Medicaid Services

See

Children and Families Administration

See

Food and Drug Administration

See

National Institutes of Health

See

Substance Abuse and Mental Health Services Administration

PROPOSED RULES Foreign Quarantine Regulations, Proposed Revision of HHS/CDC Animal Importation Regulations, 54314 2017-24951 Possession, Use, and Transfer of Select Agents and Toxins: Addition of Certain Influenza Virus Strains to the List of Select Agents and Toxins, 54314-54315 2017-24952 Total Inward Leakage Requirements for Respirators, 54315 2017-24950
Historic Historic Preservation, Advisory Council NOTICES Proposed Draft Program Comment to Exempt Effects of Transportation-Related Undertakings within Rail Rights-of-Way, 54390-54402 2017-25025 Homeland Homeland Security Department See

Coast Guard

See

Federal Emergency Management Agency

See

Transportation Security Administration

Housing Housing and Urban Development Department NOTICES Revocation of Orders of Succession for the Office of the Deputy Secretary, 54404-54405 2017-25024 Institute of Museum and Library Services Institute of Museum and Library Services NOTICES Meetings; Sunshine Act, 54420 2017-25108 Interior Interior Department See

Fish and Wildlife Service

See

Land Management Bureau

See

Surface Mining Reclamation and Enforcement Office

International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Certain Steel Nails from the Socialist Republic of Vietnam, 54320-54321 2017-24967 Light-Walled Rectangular Pipe and Tube from Mexico, 54322-54324 2017-24965 Narrow Woven Ribbon with Woven Selvedge from the People's Republic of China, 54325-54326 2017-24966 Steel Wire Garment Hangers from the People's Republic of China, 54324-54325 2017-24964 Meetings: Summit on Trade-Related Standards Issues, 54321-54322 2017-24605 International Trade Com International Trade Commission NOTICES Complaints: Certain Microperforated Packaging Containing Fresh Produce, 54411-54412 2017-24921 Investigations; Determinations, Modifications, and Rulings, etc.: Certain Mobile Device Holders and Components Thereof, 54413-54414 2017-24927 Tin- and Chromium-Coated Steel Sheet from Japan, 54412 2017-24980 Labor Department Labor Department See

Employment and Training Administration

See

Labor Statistics Bureau

See

Mine Safety and Health Administration

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Hazard Communication Standard, 54416 2017-24994 Meetings: Labor Advisory Committee for Trade Negotiation and Trade Policy, 54415-54416 2017-25011
Labor Statistics Labor Statistics Bureau NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 54416-54419 2017-24996 2017-24997 Land Land Management Bureau NOTICES Environmental Impact Statements; Availability, etc.: Draft Ray Land Exchange/Plan Amendment, AZ, 54408-54409 2017-24823 Records of Decisions: Boardman to Hemingway Transmission Line Project and Approved Land-use Plan Amendments, Oregon, 54409-54411 2017-25013 Merit Merit Systems Protection Board NOTICES FY 2015 Service Contract Inventory, 54420 2017-24904 Mine Mine Safety and Health Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Permissible Equipment Testing, 54419-54420 2017-24995 National Foundation National Foundation on the Arts and the Humanities See

Institute of Museum and Library Services

National Institute National Institutes of Health NOTICES Meetings: National Cancer Institute, 54389-54390 2017-24895 National Heart, Lung, and Blood Institute, 54388-54389 2017-24896 2017-24897 National Institute of Mental Health, 54388 2017-24899 National Institute on Alcohol Abuse and Alcoholism, 54389 2017-24898 National Oceanic National Oceanic and Atmospheric Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 54330-54332 2017-24989 2017-24990 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Alaska Commercial Operator's Annual Report, 54335 2017-24991 Endangered Species: File Nos. 20590 and 20610, 54334-54335 2017-24946 Meetings: Caribbean Fishery Management Council, 54331-54332 2017-24958 Mid-Atlantic Fishery Management Council, 54334 2017-24956 New England Fishery Management Council, 54329-54331, 54333-54334 2017-24957 2017-24959 2017-24961 North Pacific Fishery Management Council, 54332-54333 2017-24962 South Atlantic Fishery Management Council, 54327-54329 2017-24955 Western Pacific Fishery Management Council, 54326-54327 2017-24960 National Science National Science Foundation NOTICES Meetings: Advisory Committee for Integrative Activities, 54420-54421 2017-24993 Nuclear Regulatory Nuclear Regulatory Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Licenses and Radiation Safety Requirements for Irradiators, 54421-54422 2017-24987 Pipeline Pipeline and Hazardous Materials Safety Administration NOTICES Hazardous Materials: Proposed Termination of M-Number and R-Number Approvals Issued Without an Expiration Date, 54465-54466 2017-24981 Postal Regulatory Postal Regulatory Commission NOTICES New Postal Products, 54422 2017-24906 Presidential Documents Presidential Documents PROCLAMATIONS Special Observances: Vietnam War; Commemoration of the 50th Anniversary (Proc. 9674), 55023-55026 2017-25164 Securities Securities and Exchange Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 54422-54423 2017-24945 Petitions: Virtu Financial Inc., Virtu Americas, LLC; Susquehanna International Group, et al., 54439-54440 2017-24939 Self-Regulatory Organizations; Proposed Rule Changes: Cboe EDGA Exchange, Inc., 54440-54441 2017-24933 Cboe EDGX Exchange, Inc., 54442-54448, 54453-54455 2017-24929 2017-24932 2017-24936 ICE Clear Europe Limited, 54423-54425 2017-24935 Investors Exchange, LLC, 54425-54430 2017-24930 Municipal Securities Rulemaking Board, 54455-54457 2017-24928 Nasdaq BX, Inc., 54460-54463 2017-24931 NYSEArca, Inc., 54434-54437 2017-24938 The Nasdaq Stock Market LLC, 54437-54439, 54457-54460 2017-24934 2017-24937 The Options Clearing Corp., 54430-54434, 54448-54453 2017-24919 2017-24920 Small Business Small Business Administration NOTICES Major Disaster Declarations: Puerto Rico; Amendment 4, 54463 2017-24916 State Department State Department NOTICES Investigations; Determinations, Modifications, and Rulings, etc.: Central Government of Nicaragua, 54463 2017-24963 Substance Substance Abuse and Mental Health Services Administration NOTICES Meetings: Interdepartmental Serious Mental Illness Coordinating Committee, 54390 2017-24876 Surface Mining Surface Mining Reclamation and Enforcement Office RULES Congressional Nullification of the Stream Protection Rule under the Congressional Review Act, 54924-55022 2017-24307 Texas Regulatory Program, 54292-54295 2017-24620 Surface Transportation Surface Transportation Board NOTICES Discontinuance of Service Exemptions: CSX Transportation, Inc. in Dickenson County, VA, 54463-54464 2017-24900 Susquehanna Susquehanna River Basin Commission NOTICES Projects Approved for Consumptive Uses of Water, 54464 2017-24985 Projects Approved for Minor Modifications, 54464-54465 2017-24984 Projects Rescinded: Consumptive Uses of Water, 54465 2017-24986 Transportation Department Transportation Department See

Federal Aviation Administration

See

Pipeline and Hazardous Materials Safety Administration

Security Transportation Security Administration NOTICES Meetings: Aviation Security Advisory Committee, 54404 2017-24917 Treasury Treasury Department See

Foreign Assets Control Office

Veteran Affairs Veterans Affairs Department RULES Vocational Rehabilitation and Employment Nomenclature Change for Position Title, 54295-54298 2017-24949 NOTICES Meetings: National Academic Affiliations Council, 54469 2017-25009 Separate Parts In This Issue Part II Bureau of Consumer Financial Protection, 54472-54921 2017-21808 Part III Interior Department, Surface Mining Reclamation and Enforcement Office, 54924-55022 2017-24307 Part IV Presidential Documents, 55023-55026 2017-25164 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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82 221 Friday, November 17, 2017 Rules and Regulations DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 1271 [Docket No. FDA-2014-D-1584] Same Surgical Procedure Exception: Questions and Answers Regarding the Scope of the Exception; Guidance for Industry; Availability AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notification of availability.

SUMMARY:

The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled “Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception.” The guidance document provides tissue establishments and health care professionals with FDA's current thinking on the scope of an exception set forth in the human cells, tissues, and cellular and tissue-based products (HCT/Ps) regulations.

DATES:

The announcement of the guidance is published in the Federal Register on November 17, 2017.

ADDRESSES:

You may submit either electronic or written comments on Agency guidances at any time as follows:

Electronic Submissions

Submit electronic comments in the following way:

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

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

Written/Paper Submissions

Submit written/paper submissions as follows:

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

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

Instructions: All submissions received must include the Docket No. FDA-2014-D-1584 for “Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

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

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

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

Submit written requests for single copies of the guidance to the 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 the 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:

Lori J. Churchyard, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION: I. Background

FDA is announcing the availability of a document entitled “Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception.” The guidance provides tissue establishments and health care professionals with FDA's current thinking on the scope of the exception set forth in part 1271 (21 CFR part 1271), specifically the exception set forth in § 1271.15(b) (21 CFR 1271.15(b)). This guidance does not address the other exceptions in § 1271.15. The guidance, presented in question and answer format, provides FDA's current interpretation of this regulation and includes examples based on inquiries received by the Agency since the final rule entitled “Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing” published in the Federal Register of January 19, 2001 (66 FR 5447).

In the Federal Register of October 23, 2014 (79 FR 63348), FDA announced the availability of the draft guidance of the same title. Additionally, in the Federal Register of December 24, 2014 (79 FR 77414), FDA announced the availability of the draft guidance entitled “Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) from Adipose Tissue: Regulatory Considerations; Draft Guidance for Industry” dated December 2014 (Adipose Draft Guidance).

In the Federal Register of October 30, 2015, FDA reopened the comment period for three HCT/P-related draft guidances (80 FR 66847, 66849, and 66844, respectively) and announced the availability of another HCT/P-related draft guidance (80 FR 66850). Comments on the four HCT/P-related guidances were requested by April 29, 2016. Lastly, in the Federal Register of October 30, 2015 (80 FR 66845), FDA announced a 1-day part 15 (21 CFR part 15) public hearing to obtain input on the four HCT/P-related guidances to be held on April 13, 2016.

Due to considerable interest in the public hearing and to give stakeholders additional time to provide comments to the Agency, on February 29, 2016, FDA announced that the hearing was postponed. In the Federal Register of April 22, 2016 (81 FR 23661 and 81 FR 23664, respectively), FDA announced the rescheduled part 15 hearing date of September 12 and 13, 2016, and an extension of the comment period from April 29, 2016, until September 27, 2016, on the four HCT/P-related guidances. Also in the Federal Register of April 22, 2016 (81 FR 23708), FDA announced a public workshop to be held on September 8, 2016, on the “Scientific Evidence in Development of HCT/Ps Subject to Premarket Approval.”

FDA received numerous comments on the draft guidance and the Adipose Draft Guidance in response to the request for comments, and those comments were considered in developing the final guidance. The guidance announced in this notification finalizes the draft guidance of the same title dated October 2014. This guidance also finalizes certain material related to adipose tissue that was included in the Adipose Draft Guidance.

The material in this guidance related to adipose tissue, together with the material in the final guidance entitled “Regulatory Considerations for Human Cell, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use; Guidance for Industry and Food and Drug Administration Staff” dated November 2017 (Minimal Manipulation and Homologous Use Guidance) related to adipose tissue, supersedes the Adipose Draft Guidance. Accordingly, FDA does not intend to finalize the Adipose Draft Guidance, which is now withdrawn.

Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the Minimal Manipulation and Homologous Use Guidance.

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on “Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

The guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in part 1271 have been approved under OMB control number 0910-0543.

III. Electronic Access

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

Dated: November 13, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-24839 Filed 11-16-17; 8:45 am] BILLING CODE 4164-01-P
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 1271 [Docket No. FDA-2017-D-6146] Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use; Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notification of availability.

SUMMARY:

The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled “Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use; Guidance for Industry and Food and Drug Administration Staff.” The guidance provides human cells, tissues, and cellular and tissue-based product (HCT/P) manufacturers, healthcare providers, and FDA staff, with FDA's current thinking on the regulatory criteria of minimal manipulation and homologous use. The guidance is intended to improve stakeholders' understanding of the definitions of minimal manipulation and homologous use and how the regulatory criteria apply to their HCT/Ps. It also informs manufacturers, healthcare providers, and other interested persons that the Agency generally intends to exercise enforcement discretion over the next 36 months under limited conditions, with respect to the investigational new drug (IND) application and premarket approval (biologics license application (BLA)) requirements, for certain HCT/Ps.

DATES:

The announcement of the guidance is published in the Federal Register on November 17, 2017.

ADDRESSES:

You may submit either electronic or written comments on Agency guidances at any time as follows:

Electronic Submissions

Submit electronic comments in the following way:

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

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

Written/Paper Submissions

Submit written/paper submissions as follows:

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

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

Instructions: All submissions received must include the Docket No. FDA-2017-D-6146 for “Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use; Guidance for Industry and Food and Drug Administration Staff.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

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

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

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

Submit written requests for single copies of the guidance to the 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; or to the Office of the Center Director, Guidance and Policy Development, Center for Devices and Radiological Health (CDRH), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002; or you may send an email request to the Office of Combination Products (OCP) at [email protected] If you are submitting a written request, send one self-addressed adhesive label to assist that office in processing your request. 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:

Lori J. Churchyard, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911; or Angela Krueger, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1676, Silver Spring, MD 20993-0002, 301-796-6380; or Leigh Hayes, Office of Combination Products, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5129, Silver Spring, MD 20993-0002, 301-796-8938.

SUPPLEMENTARY INFORMATION: I. Background

FDA is announcing the availability of a document entitled “Regulatory Considerations for Human Cells, Tissues, Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use; Guidance for Industry and Food and Drug Administration Staff.” The guidance provides HCT/P manufacturers, healthcare providers, and FDA staff, with our current thinking on the criteria under part 1271 (21 CFR part 1271), specifically the § 1271.10(a)(1) (21 CFR 1271.10(a)(1)) criterion of minimal manipulation and the § 1271.10(a)(2) criterion of homologous use. The interpretation of the minimal manipulation and homologous use criteria and definitions of related key terms have been of considerable interest to industry stakeholders since the criteria and definitions were first proposed.1 The guidance document is intended to improve stakeholders' understanding of the definitions of minimal manipulation in § 1271.3(f) and homologous use in § 1271.3(c). It will also facilitate stakeholders' understanding of how the regulatory criteria in § 1271.10(a)(1) and (2) apply to their HCT/Ps. The guidance document explains the regulatory scope of the regulations, as well as the Agency's compliance policy regarding certain regulatory requirements relating to HCT/Ps. In addition, the guidance document informs manufacturers, health care providers, and other interested persons that over the next 36 months, we intend to exercise enforcement discretion under limited conditions with respect to the IND application or premarket approval (BLA) requirements, for certain HCT/Ps.

1 “Establishment Registration and Listing for Manufacturers of Human Cellular and Tissue-Based Products” 63 FR 26744 at 26748-49 (May 14, 1998) https://www.thefederalregister.org/fdsys/pkg/FR-1998-05-14/pdf/98-12751.pdf.

In the Federal Register of December 23, 2014 (79 FR 77012), FDA announced the availability of the draft guidance entitled “Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and Food and Drug Administration Staff” dated December 2014 (Minimal Manipulation Draft Guidance), and in the Federal Register of December 24, 2014 (79 FR 77414), FDA announced the availability of draft guidance entitled “Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) from Adipose Tissue: Regulatory Considerations; Draft Guidance for Industry” dated December 2014 (Adipose Draft Guidance). Additionally, in the Federal Register of October 30, 2015 (80 FR 66850), FDA announced the availability of the draft guidance entitled “Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and FDA Staff” dated October 2015 (Homologous Use Draft Guidance).

Also in the Federal Register of October 30, 2015, FDA reopened the comment period on the Minimal Manipulation Draft Guidance (80 FR 66844), Adipose Draft Guidance (80 FR 66849), and a third HCT/P-related guidance addressing the same surgical procedure exception in § 1271.15(b) (80 FR 66847) (Same Surgical Procedure Exception Draft Guidance). Comments on these three HCT/P-related guidances, as well as the Homologous Use Draft Guidance, were requested by April 29, 2016. Lastly, the Federal Register of October 30, 2015 (80 FR 66845), FDA announced a 1-day part 15 (21 CFR part 15) public hearing to obtain input on the four HCT/P-related guidances to be held on April 13, 2016.

Due to considerable interest in the public hearing and to give stakeholders additional time to provide comments to the Agency, on February 29, 2016, FDA announced that the hearing was postponed. In the Federal Register of April 22, 2016 (81 FR 23661 and 81 FR 23664, respectively), FDA announced the rescheduled part 15 hearing date of September 12 and 13, 2016, and an extension of the comment period from April 29, 2016, until September 27, 2016, on the four HCT/P-related guidances. Also in the Federal Register of April 22, 2016 (81 FR 23708), FDA announced a public workshop on the “Scientific Evidence in Development of HCT/Ps Subject to Premarket Approval.”

FDA received numerous comments on the Minimal Manipulation Draft Guidance, Homologous Use Draft Guidance, and the Adipose Draft Guidance in response to the request for comments, and those comments were considered in developing the final guidance in this notification.

The guidance document announced in this notification finalizes the Minimal Manipulation Draft Guidance and the Homologous Use Draft Guidance. The guidance document also finalizes certain material related to adipose tissue that was included in the Adipose Draft Guidance. The material in this guidance document related to adipose tissue, together with the material related to adipose tissue included in the guidance finalizing the Same Surgical Procedure Exception Draft Guidance, the availability of which is announced elsewhere in this issue of the Federal Register, supersedes the Adipose Draft Guidance. Accordingly, FDA does not intend to finalize the Adipose Tissue Guidance, which is now withdrawn. Finally, this guidance supersedes the guidance entitled “Minimal Manipulation of Structural Tissue (Jurisdictional Update) Guidance for Industry and FDA Staff” dated September 2006.

FDA is also announcing via this Federal Register notification that, with the publication of this guidance document, it will cease posting the Tissue Reference Group (TRG) annual reports on FDA's Web site. The TRG was created as specified in the “Proposed Approach to the Regulation of Cellular and Tissue-Based Products” dated February 28, 1997 (March 4, 1997; 62 FR 9721). The purpose of the TRG is to provide a single reference point for product specific questions received by FDA (either through the Centers, or from the Office of Combination Products) concerning jurisdiction and applicable regulation of HCT/Ps.

In 1998, the TRG began publishing its recommendations in an annual report that was posted on FDA's Web site. Originally intended to assist industry in understanding the scientific rationale for the TRG recommendations, the recommendations are stated in general terms in order to protect proprietary information. As a result, FDA has received feedback from stakeholders that the annual reports do not provide helpful information. Therefore, we are announcing that although the TRG will continue to provide recommendations, the TRG annual reports will no longer be posted on FDA's Web site. We note that this final guidance is intended to help clarify the minimal manipulation and homologous use criteria in § 1271.10(a)(1) and (2), and thus addresses many of the questions that had been posed to the TRG.

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on “Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

The guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in part 1271 have been approved under OMB control number 0910-0543.

III. Electronic Access

Persons with access to the internet may obtain the guidance at either https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm; or https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm; or https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/default.htm; or https://www.regulations.gov.

Dated: November 13, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-24838 Filed 11-16-17; 8:45 am] BILLING CODE 4164-01-P
DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 943 [SATS No. TX-067-FOR; Docket ID: OSM-2016-0001; S1D1S SS08011000 SX064A000 189S180110; S2D2S SS08011000 SX064A000 18XS501520] Texas Regulatory Program AGENCY:

Office of Surface Mining Reclamation and Enforcement, Interior.

ACTION:

Final rule.

SUMMARY:

We, the Office of Surface Mining Reclamation and Enforcement (OSMRE), are approving an amendment to the Texas regulatory program (Texas program) under the Surface Mining Control and Reclamation Act of 1977 (SMCRA or the Act). Texas proposed revisions to its regulations regarding annual permit fees. Texas revised its program at its own initiative to raise revenues sufficient to cover its anticipated share of costs to administer the coal regulatory program and to encourage mining companies to more quickly reclaim lands and request bond release, thereby fulfilling SMCRA's purpose of assuring the reclamation of mined land as quickly as possible.

DATES:

The effective date is December 18, 2017.

FOR FURTHER INFORMATION CONTACT:

William L. Joseph, Director, Tulsa Field Office. Telephone: (918) 581-6430. Email: [email protected]

SUPPLEMENTARY INFORMATION:

I. Background on the Texas Program II. Submission of the Amendment III. OSMRE's Findings IV. Summary and Disposition of Comments V. OSMRE's Decision VI. Procedural Determinations I. Background on the Texas Program

Section 503(a) of the Act permits a State to assume primacy for the regulation of surface coal mining and reclamation operations on non-Federal and non-Indian lands within its borders by demonstrating that its State program includes, among other things, State laws and regulations that govern surface coal mining and reclamation operations in accordance with the Act and consistent with the Federal regulations. See 30 U.S.C. 1253(a)(1) and (7). On the basis of these criteria, the Secretary of the Interior conditionally approved the Texas program, effective February 16, 1980. You can find background information on the Texas program, including the Secretary's findings, the disposition of comments, and the conditions of approval, in the February 27, 1980, Federal Register (45 FR 12998, 13008). You can find later actions on the Texas program at 30 CFR 943.10, 943.15, and 943.16.

II. Submission of the Amendment

By letter dated November 17, 2015 (Administrative Record No. TX-705), and on its own initiative, Texas sent us an amendment to its program under SMCRA (30 U.S.C. 1201 et seq.). We announced receipt of the proposed amendment in the April 08, 2016, Federal Register (81 FR 20591). In the same document, we opened the public comment period and provided an opportunity for a public hearing or meeting on the adequacy of the amendment. We did not hold a public hearing or meeting because no one requested one. The public comment period ended on May 09, 2016. We did not receive any public comments.

III. OSMRE's Findings

The following are the findings we made concerning the amendment under SMCRA and the Federal regulations at 30 CFR 732.15 and 732.17. We are approving the amendment as described below.

16 Texas Administrative Code (TAC) Section 12.108 Permit Fees

Texas proposed to revise its regulations at 16 TAC Sections 12.108(b)(1)-(3), adjusting the annual coal mining permit fees for calendar years 2015 and 2016. Fees for mining activities during calendar years 2015 and 2016 were to be paid by coal mine operations by March 15th of the year following the calendar year for which the fees are applicable.

By this amendment, Texas has:

(1) Repealed paragraph (b)(1) regarding a fee for each acre of land within the permit area on which coal or lignite was actually removed during the calendar year;

(2) Renumbered existing paragraphs (b)(2) and (3) to read as (b)(1) and (2) respectively;

(3) Increased the fee in the new paragraph (b)(1) from $12.00 to $13.05 for each acre of land within a permit area covered by a reclamation bond on December 31st of the year; and

(4) Increased the fee in the new paragraph (b)(2) from $6,540.00 to $6,600.00 for each permit in effect on December 31st of the year.

The Federal regulations at 30 CFR 777.17 provide that applications for surface coal mining permits must be accompanied by a fee determined by the regulatory authority. The Federal regulations also provide that the fees may be less than, but not more than, the actual or anticipated cost of reviewing, administering, and enforcing the permit.

Texas' amendment describes how its coal mining regulatory program is funded. Texas operates on a biennial budget which appropriates general revenue funds for permitting and inspecting coal mining facilities within the state. This appropriation is contingent on the Railroad Commission of Texas (Commission) assessing fees sufficient to generate revenue to recover the general revenue appropriation. When calculating anticipated costs to the Commission for regulating coal mining activity, Texas anticipates OSMRE providing some grant funding for regulatory program costs based on Section 705(a) of SMCRA. Texas estimated that annual fees at the revised amounts in this amendment would result in revenue that, when coupled with permit application fees, was not expected to provide for more than 50 percent of the anticipated regulatory program costs during each year of the biennium. OSMRE agrees that this is a reasonable expectation in light of recent reductions in overall funding to states that have resulted in them receiving less than fifty percent of their anticipated regulatory program costs.

Texas adjusts its fees biennially to recover the amounts expended from state appropriations in accordance with a formula and schedule agreed to in 2005 by the coal mining industry and the Commission. This amendment represents the sixth adjustment to surface mining fees based upon that agreement.

We find that Texas' fee changes are consistent with the discretionary authority provided by the Federal regulation at 30 CFR 777.17. Therefore, OSMRE approves Texas' permit fee changes, recognizing that Texas has a process to adjust its fees to cover the cost of its regulatory program not covered by the Federal grant.

IV. Summary and Disposition of Comments Public Comments

We asked for public comments on the amendment but did not receive any.

Federal Agency Comments

On February 11, 2016, pursuant to 30 CFR 732.17(h)(11)(i) and Section 503(b) of SMCRA, we requested comments on the amendment from various Federal agencies with an actual or potential interest in the Texas program (Administrative Record No. TX-705.01). We did not receive any comments.

Environmental Protection Agency (EPA) Concurrence and Comment

Under 30 CFR 732.17(h)(11)(ii), we are required to get written concurrence from EPA for those provisions of the program amendment that relate to air or water quality standards issued under the authority of the Clean Water Act (33 U.S.C. 1251 et seq.) or the Clean Air Act (42 U.S.C. 7401 et seq.). None of the revisions that Texas proposed to make in this amendment pertain to air or water quality standards. Therefore, we did not ask EPA to concur on the amendment. However, on February 11, 2016, under 30 CFR 732.17(h)(11)(i), we requested comments from the EPA on the amendment (Administrative Record No. TX-705.1). The EPA did not respond to our request.

State Historical Preservation Officer (SHPO) and the Advisory Council on Historic Preservation (ACHP)

Under 30 CFR 732.17(h)(4), we are required to request comments from the SHPO and ACHP on amendments that may have an effect on historic properties. On February 11, 2016, we requested comments on Texas' amendment (Administrative Record No. TX-705.01), but neither the SHPO nor ACHP responded to our request.

V. OSMRE's Decision

Based on the above findings, we approve the amendment Texas submitted to the OSMRE on November 17, 2015 (Administrative Record No. TX-705).

To implement this decision, we are amending the Federal regulations at 30 CFR part 943 that codify decisions concerning the Texas program. In accordance with the Administrative Procedure Act, this rule will take effect 30 days after the date of publication. Section 503(a) of SMCRA requires that the State's program demonstrate that they have the capability of carrying out the provisions of the Act and meeting its purposes. SMCRA requires consistency of State and Federal standards.

VI. Procedural Determinations Executive Order 12630—Takings

This rulemaking does not have takings implications. This determination is based on the analysis performed for the counterpart Federal regulation.

Executive Order 12866—Regulatory Planning and Review

This rulemaking is exempted from review by the Office of Management and Budget (OMB) under Executive Order 12866.

Executive Order 12988—Civil Justice Reform

The Department of the Interior has conducted the reviews required by section 3 of Executive Order 12988 and has determined that this rulemaking meets the applicable standards of subsections (a) and (b) of that section. However, these standards are not applicable to the actual language of State regulatory programs and program amendments because each program is drafted and promulgated by a specific State, not by OSMRE. Under sections 503 and 505 of SMCRA (30 U.S.C. 1253 and 1255) and the Federal regulations at 30 CFR 730.11, 732.15, and 732.17(h)(10), decisions on proposed State regulatory programs and program amendments submitted by the States must be based solely on a determination of whether the submittal is consistent with SMCRA and its implementing Federal regulations and whether the other requirements of 30 CFR parts 730, 731, and 732 have been met.

Executive Order 13132—Federalism

This rulemaking does not have Federalism implications. SMCRA delineates the roles of the Federal and State governments with regard to the regulation of surface coal mining and reclamation operations. One of the purposes of SMCRA is to “establish a nationwide program to protect society and the environment from the adverse effects of surface coal mining operations.” Section 503(a)(1) of SMCRA requires that State laws regulating surface coal mining and reclamation operations be “in accordance with” the requirements of SMCRA, and section 503(a)(7) requires that State programs contain rules and regulations “consistent with” regulations issued by the Secretary pursuant to SMCRA.

Executive Order 13175—Consultation and Coordination With Indian Tribal Governments

In accordance with Executive Order 13175, we have evaluated the potential effects of this rulemaking on Federally-recognized Indian tribes and have determined that the rulemaking does not have substantial direct effects 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. The basis for this determination is that our decision is on a State regulatory program and does not involve Federal regulations involving Indian lands.

Executive Order 13211—Regulations That Significantly Affect the Supply, Distribution, or Use of Energy

Executive Order 13211 of May 18, 2001, requires agencies to prepare a Statement of Energy Effects for a rulemaking that is (1) considered significant under Executive Order 12866, and (2) likely to have a significant adverse effect on the supply, distribution, or use of energy. Because this rulemaking is exempt from review under Executive Order 12866 and is not expected to have a significant adverse effect on the supply, distribution, or use of energy, a Statement of Energy Effects is not required.

National Environmental Policy Act

This rulemaking does not require an environmental impact statement because section 702(d) of SMCRA (30 U.S.C. 1292(d)) provides that agency decisions on proposed State regulatory program provisions do not constitute major Federal actions within the meaning of section 102(2)(C) of the National Environmental Policy Act (42 U.S.C. 4332(2)(C)).

Paperwork Reduction Act

This rulemaking does not contain information collection requirements that require approval by OMB under the Paperwork Reduction Act (44 U.S.C. 3507 et seq.).

Regulatory Flexibility Act

The Department of the Interior certifies that this rulemaking will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). The State submittal, which is the subject of this rulemaking, is based upon counterpart Federal regulations for which an economic analysis was prepared and certification made that such regulations would not have a significant economic effect upon a substantial number of small entities. In making the determination as to whether this rulemaking would have a significant economic impact, the Department relied upon the data and assumptions for the counterpart Federal regulations.

Small Business Regulatory Enforcement Fairness Act

This rulemaking is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. This rulemaking: (a) Does not have an annual effect on the economy of $100 million; (b) Will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions; and (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. This determination is based upon the fact that the State submittal, which is the subject of this rulemaking, is based upon counterpart Federal regulations for which an analysis was prepared and a determination made that the Federal regulation was not considered a major rule.

Unfunded Mandates

This rulemaking will not impose an unfunded mandate on State, local, or tribal governments or the private sector of $100 million or more in any given year. This determination is based upon the fact that the State submittal, which is the subject of this rulemaking, is based upon counterpart Federal regulations for which an analysis was prepared and a determination made that the Federal regulation did not impose an unfunded mandate.

List of Subjects in 30 CFR Part 943

Intergovernmental relations, Surface mining, Underground Mining.

Dated: October 31, 2017. Alfred L. Clayborne, Regional Director, Mid-Continent Region.

For the reasons set out in the preamble, 30 CFR part 943 is amended as set forth below:

PART 943—TEXAS 1. The authority citation for Part 943 continues to read as follows: Authority:

30 U.S.C. 1201 et seq.

2. In § 943.15, the table is amended by adding a new entry in chronological order to read as follows:
§ 943.15 Approval of Texas regulatory program amendments. Original amendment submission date Date of final publication Citation/description *         *         *         *         *         *         * November 17, 2015 November 17, 2017 16 TAC 12.108(b)(1)-(3).
[FR Doc. 2017-24620 Filed 11-16-17; 8:45 am] BILLING CODE 4310-05-P
DEPARTMENT OF VETERANS AFFAIRS 38 CFR Part 21 RIN 2900-AQ11 VA Vocational Rehabilitation and Employment Nomenclature Change for Position Title—Revision AGENCY:

Department of Veterans Affairs.

ACTION:

Interim final rule.

SUMMARY:

The Department of Veterans Affairs (VA) published a final rule in the Federal Register on May 2, 2016, which amended a number of regulations in the Code of Federal Regulations (CFR) to authorize personnel hired by VA's Vocational Rehabilitation and Employment (VR&E) Service under the title “Vocational Rehabilitation Counselor” (VRC) to make the same determinations with respect to Chapter 31 services and benefits as personnel who had been hired under the title “Counseling Psychologist” (CP). The preamble to that final rule cited supporting documents inaccurately and failed to properly explain the qualifications for and duties of this VR&E position responsible for making determinations with respect to Chapter 31 services and benefits. This interim final rule corrects those inaccuracies, more clearly explains the basis for the final rule, and invites public comment on the changes made to VA's regulations in the May 2, 2016, final rule.

DATES:

Effective Date: This interim final rule is effective November 17, 2017. VA must receive comments on or before December 18, 2017.

ADDRESSES:

Submit written comments through http://www.Regulations.gov; by mail or hand-delivery to: Director, Regulations Management (00REG), Department of Veterans Affairs, 810 Vermont Ave. NW., Room 1063B, Washington, DC 20420; or by fax to (202) 273-9026. (This is not a toll-free telephone number.) Comments should indicate that they pertain to “RIN 2900-AQ11, VA Vocational Rehabilitation and Employment Nomenclature Change for Position Title—Revision.” Copies of comments received will be available for public inspection in the Office of Regulation Policy and Management, Room 1063B, between the hours of 8:00 a.m. and 4:30 p.m., Monday through Friday (except holidays). Please call (202) 461-4902 for an appointment. (This is not a toll-free telephone number.) In addition, comments may be viewed online through the Federal Docket Management System (FDMS) at http://www.Regulations.gov.

FOR FURTHER INFORMATION CONTACT:

C.J. Riley, Senior Policy Analyst, Vocational Rehabilitation and Employment Service (28), Veterans Benefits Administration, Department of Veterans Affairs, 810 Vermont Avenue NW., Washington, DC 20420, [email protected], (202) 461-9600. (This is not a toll-free telephone number.)

SUPPLEMENTARY INFORMATION:

In a final rule published in the Federal Register on May 2, 2016, at 81 FR 26130, VA amended a number of regulations in Part 21, CFR, to add the title “VRC” for the position responsible for making certain determinations with respect to Chapter 31 services and benefits. In the preamble to the final rule, we stated that the revisions were non-substantive and intended to reflect the fact that the CP and VRC position titles are synonymous because the positions have the same job duties and qualifications. We also stated that the final rule was necessary to ensure consistency. The preamble referenced a performance plan that was purportedly implemented on December 16, 2003, that described how the job duties of and qualifications for a CP and VRC were the same. However, the performance plan was implemented on July 1, 2004, rather than on December 16, 2003, and does not provide that the two positions have the same qualifications. Nonetheless, VRCs are fully qualified to perform the duties specified in Chapter 31 regulations. Therefore, because reversing the changes published in the Federal Register on May 2, 2016, would be harmful to Veterans seeking vocational rehabilitation services for reasons discussed below, we are not reversing those changes at this time. However, VA is seeking public comment on those changes, as further explained in this document. The explanation that follows corrects the inaccuracies in the preamble to the final rule and more clearly explains the basis for the rule.

VA's VR&E program serves an important function: To assist Veterans who have service-connected disabilities and barriers to employment in obtaining and maintaining suitable employment and achieving maximum independence in daily living. In 1996, VA began to allow use of Office of Personnel Management (OPM) classification series GS-0101, Social Science, to hire personnel under the title “VRC” to provide rehabilitation services. Such services include, but are not limited to, deciding eligibility and entitlement, developing rehabilitation plans, and delivering case management services. VA's VR&E program had previously hired personnel under the title “CP,” OPM classification series GS-0180, Psychology, to provide these types of rehabilitation services. Since 1996, after use of the GS-0101 series was allowed, the VR&E program had hired personnel under either series to provide the same types of rehabilitation services and perform the same work. In 2015, VA's Office of Human Resources and Administration concluded that use of the GS-0180 series was not as appropriate as use of the GS-0101 series for personnel whom VA hires to provide rehabilitation services, because the majority of the duties these VR&E personnel perform most closely meets the standards associated with the GS-0101 series. Accordingly, VA discontinued use of the GS-0180 series for these VR&E positions. Although the VR&E program began to fill vacant positions using the GS-0101 series under the “VRC” title, the personnel who had been hired using GS-0180 series under the “CP” title kept their title and continued to perform under their existing position descriptions.

VR&E Service had updated a few, but not all, regulations governing the delivery of Chapter 31 services and benefits to reflect the hiring of personnel under the title “VRC” for the position responsible for making certain determinations. Specifically, on April 11, 1997 (62 FR 17706), VA issued a final rule defining VRC in 38 CFR 21.35. On March 26, 2007 (72 FR 14041), VA issued a final rule revising 38 CFR 21.50, 21.51, and 21.52 to describe determinations that a VRC may make during an initial evaluation, including the existence of an employment handicap and a serious employment handicap. On January 20, 2010 (75 FR 3165), VA issued a final rule revising 38 CFR 21.42, 21.44, and 21.45 to specify determinations that a VRC may make regarding a claimant's eligibility period to receive Chapter 31 services.

In September 2014, a Veteran advocate contacted VR&E Service and indicated that he believed that VA had erroneously denied benefits because VA improperly interpreted regulations regarding the roles of CPs and VRCs when making specific determinations. Additionally, the Board of Veterans' Appeals has remanded cases to regional offices with instructions for a CP to make determinations that a VRC already made, noting that regulations require CPs to make these determinations. Because the VR&E program stopped hiring under the “CP” title, the VR&E program's national workforce does not have enough CPs to comply with these instructions. Thus, on May 2, 2016, we amended the remainder of our regulations regarding the roles of CPs and VRCs to ensure consistency with respect to position titles and to clarify that VRCs are authorized to make the same determinations as CPs with regard to Chapter 31 services and benefits.

The shift towards staffing the VR&E positions responsible for making certain determinations with respect to Chapter 31 services and benefits under the VRC title rather than under the CP title reflects a more appropriate classification based on OPM standards and the type of work performed. This shift does not reflect a material change in the duties of or qualifications for the position. Regardless of the classification, VRCs perform the same duties as CPs perform in the VR&E program, and VRCs are fully qualified to perform these duties.

Section 3118(c) of title 38, United States Code, requires VA to establish the necessary and appropriate qualifications for personnel providing evaluation and rehabilitation services under Chapter 31, and to take into account the qualifications established for comparable personnel under the Rehabilitation Act of 1973 (29 U.S.C. Chapter 16). Under this Act, comparable personnel are required to have a baccalaureate degree in a field of study reasonably related to vocational rehabilitation and at least one year of experience working with individuals with disabilities, providing direct service or advocacy, or having direct experience as an employer. In lieu of the experience, personnel may obtain a master's or doctoral degree in a field of study such as vocational rehabilitation counseling, law, social work, psychology, disability studies, or special education. See 29 U.S.C. 721(a)(7)(B)(ii).

VA implemented section 3118(c) by prescribing the qualifications for VRCs in VA's Staffing Handbook (VA Handbook 5005/6, Part II, Appendix F2 (June 3, 2004)). The VR&E program requires all personnel hired as VRCs to hold a master's degree in rehabilitation counseling, including an internship, or in counseling psychology, or a related field, including at least 30 semester hours of course work in the foundations of rehabilitation counseling, human growth and development, counseling theories and techniques, vocational assessment, career development, job placement, case management, or medical/psycho-social aspects of disability. In addition, total graduate study must have included or been supplemented by a supervised internship or successful professional experience following the completion of the master's degree. These requirements are comparable to the requirements applicable to CP positions but are more accurately aligned with the needs of the VR&E program, which is focused on helping Veterans obtain and maintain suitable employment. See the OPM Web site describing general qualifications for CP classification, https://www.opm.gov/policy-data-oversight/classification-qualifications/general-schedule-qualification-standards/0100/psychology-series-0180/ (last visited August 10, 2017). Requiring VRCs to have these qualifications puts them in a similar position to CPs, who are required to have comparable qualifications. With comparable qualifications and experience in the closely related fields of counseling psychology and/or rehabilitation counseling, both VRCs and CPs have the same skills and capabilities necessary to perform the duties required for this program, such as counseling, rehabilitation, and employment assistance.

Additionally, as indicated in the most recent VRC position description released with VR&E Letter 28-14-13 on February 20, 2014, VRCs must possess knowledge of psychological, rehabilitation, and counseling theory and principle, as well as special knowledge of rehabilitation counseling skills, techniques, and resources needed to work with Veterans with multiple serious disabilities, Veterans who are largely confined to their homes due to disabilities, Veterans who have serious mental disabilities, and Veterans who have problems adjusting to social and occupational demands. VRCs must also have knowledge of the principles and procedures of psychological and vocational testing and research statistics used to assess a Veteran's interests, aptitudes, abilities, and personality characteristics. In addition, VRCs must know the requirements for independent living, and understand the limitations of, and services required by, individuals with severe disabilities. Finally, VRCs must know career development theory and job placement, and understand current labor market conditions and occupational trends and how to improve employability using the information obtained from transferable work-skills analyses.

Staffing the program with VRCs is a valid programmatic choice because, equipped with such knowledge, VRCs can capably and competently perform the required counseling, rehabilitation, and employment assistance tasks. For example, VRCs have knowledge of psychological, rehabilitation, and counseling theory and principle, and possess rehabilitation counseling skills and techniques to work with emotionally and physically-disabled individuals and prepare them for suitable employment. They understand the requirements for independent living and the services individuals with severe disabilities require, and they possess the skills and qualifications to effectively perform initial evaluations and make accurate eligibility determinations. Additionally, they know the principles and procedures of psychological and vocational testing and research statistics to competently assess a Veteran's interests, aptitudes, abilities, and personality characteristics to provide the most appropriate rehabilitation planning services. Finally, they have a comprehensive understanding of current labor market conditions and occupational trends to identify the appropriate employment options for each individual they counsel. Requiring VRCs to have such knowledge ensures that VRCs have the capability to assist Veterans with service-connected disabilities in achieving maximum independence in daily living and obtaining and maintaining suitable employment.

Because VRCs are fully qualified to perform the duties of this VR&E position, and because the VR&E program's national workforce does not have enough CPs to fulfill all the required duties of this position, we amended our regulations to authorize VRCs to make the same determinations as CPs with regard to Chapter 31 services and benefits. Accordingly, we adopt, without change, the rule published in the Federal Register on May 2, 2016.

Administrative Procedure Act

In accordance with 5 U.S.C. 553(b)(B) and (d)(3), the Secretary finds that there is good cause to dispense with the opportunity for prior notice and comment and good cause to publish this rule with an immediate effective date. The Secretary finds that it is impracticable and contrary to the public interest to delay this rule for the purpose of soliciting prior public comment or to have a delayed effective date, or to reverse the changes made on May 2, 2016, while public comment is being received. The Secretary is issuing this rule to clear up confusion among Veterans and prevent a detrimental impact with regard to the VR&E program. Failure to incorporate the VRC position title in VR&E regulations would result ultimately in a long delay in the processing of Veterans' cases and the provision of VR&E services and assistance.

The VR&E program no longer hires employees under the CP title. This is the unavoidable result of the conclusion that the GS-0101 classification series is more appropriate than the GS-0180 classification series. Accordingly, the overwhelming majority of the VR&E program's national workforce providing vocational rehabilitation and employment services are VRCs, with only 10 CPs remaining in the VR&E workforce. Therefore, the program does not have enough CPs to meet workload demands. If we did not maintain the May 2, 2016, changes to our regulations while public comment is being received, and CPs were required to make decisions in every VR&E case as part of the rehabilitation process, many decisions would be delayed and processing Veteran cases would be greatly impacted. As a result, there would be a significant delay in Veterans receiving the VR&E services and assistance to which they are entitled.

The VR&E program provided evaluation and counseling services to 173,599 Veterans in 2016. Although some regulations had already been updated to allow VRCs to perform some VR&E program duties, the regulations governing the majority of evaluation, counseling, and case management services were updated to allow VRCs to provide these services in the May 2, 2016, rulemaking. If we did not maintain the May 2, 2016, changes to our regulations, most of the 173,599 Veterans the VR&E program serves annually would not receive evaluation, counseling, and case management services in a timely manner because the 10 CPs the VR&E program employs could not possibly provide these services to so many Veterans. It would not be in the best interest of veterans to limit hundreds of VRCs to highly circumscribed duties while thousands of Veterans seeking employment services from VA wait for service from the 10 CPs VA still has in its workforce.

Additionally, the rule clears up confusion among VR&E program participants regarding the two positions titles, VRC and CP, and the respective roles of the two positions within the VR&E program. Because of this confusion, it was necessary to update the VR&E regulations to specify that these two positions are both authorized to perform the same duties.

Because this interim final rule will serve to clarify roles with regard to two position titles used within the VR&E program, and alleviate confusion related to the titles, and because it will serve to prevent delay in Veterans receiving the VR&E services and assistance to which they are entitled, the Secretary finds that it is impracticable and contrary to the public interest to delay this rule for the purpose of soliciting advance public comment or to have a delayed effective date. Accordingly, VA is issuing this rule as an interim final rule with an immediate effective date. We will consider and address any comments received within 60 days of the date this interim final rule is published in the Federal Register.

Executive Orders 12866 and 13563

Executive Orders 12866 and 13563 direct agencies to assess the 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 effects, and other advantages; distributive impacts; and equity). Executive Order 13563 (Improving Regulation and Regulatory Review) emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. Executive Order 12866 (Regulatory Planning and Review) defines a “significant regulatory action” requiring review by the OMB, unless OMB waives such review, as “any regulatory action that is likely to result in a rule that may: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities; (2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in this Executive Order.”

VA has examined the economic, interagency, budgetary, legal, and policy implications of this regulatory action and determined they are not significant under Executive Order 12866. VA's impact analysis can be found as a supporting document at http://www.regulations.gov, usually within 48 hours after the rulemaking document is published. Additionally, a copy of the rulemaking and its impact analysis are available on VA's Web site at http://www.va.gov/orpm by following the link for “VA Regulations Published From FY 2004 Through Fiscal Year To Date.”

Paperwork Reduction Act

This rule contains no collections of information under the Paperwork Reduction Act (44 U.S.C. 3501-3521).

Regulatory Flexibility Act

The Secretary hereby certifies that this interim final rule will not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act, 5 U.S.C. 601-612. This rule will not directly affect any small entities; only individuals will be directly affected. Therefore, pursuant to 5 U.S.C. 605(b), this rule is exempt from the initial and final regulatory flexibility analysis requirements of sections 603 and 604.

Unfunded Mandates

The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any one year. This interim final rule will have no such effect on State, local, and tribal governments, or on the private sector.

Catalog of Federal Domestic Assistance

The Catalog of Federal Domestic Assistance number and title for the program affected by this document is 64.116, Vocational Rehabilitation for Disabled Veterans.

Signing Authority

The Secretary of Veterans Affairs, or designee, approved this document and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. Gina S. Farrisee, Deputy Chief of Staff, Department of Veterans Affairs, approved this document on October 23, 2017 for publication.

List of Subjects in 38 CFR Part 21

Administrative practice and procedure, Armed forces, Civil rights, Claims, Colleges and universities, Conflict of interests, Education, Employment, Grant programs—education, Grant programs—veterans, Health care, Loan programs—education, Loan programs—veterans, Manpower training programs, Reporting and recordkeeping requirements, Schools, Travel and transportation expenses, Veterans, Vocational education, Vocational rehabilitation.

Dated; November 14, 2017. Michael Shores, Director, Office of Regulation Policy & Management, Office of the Secretary, Department of Veterans Affairs. For the reasons set out in the preamble, the regulatory amendments in the final rule published in the Federal Register on May 2, 2016, at 81 FR 26130, and incorporated in the CFR are affirmed. Only the preamble originally published on May 2, 2016, at 81 FR 26130, is hereby replaced.
[FR Doc. 2017-24949 Filed 11-16-17; 8:45 am] BILLING CODE 8320-01-P
ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R03-OAR-2017-0149; FRL-9970-82-Region 3] Approval and Promulgation of Air Quality Implementation Plans; Maryland; 2011 Base Year Inventory for the 2008 8-Hour Ozone National Ambient Air Quality Standard for the Maryland Portion of the Philadelphia-Wilmington-Atlantic City Nonattainment Area; Withdrawal AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Withdrawal of direct final rule.

SUMMARY:

Due to the receipt of an adverse comment, the Environmental Protection Agency (EPA) is withdrawing the September 25, 2017 direct final rule that approved the 2011 base year inventory for the Maryland portion of the Philadelphia-Wilmington-Atlantic City marginal nonattainment area for the 2008 8-hour ozone national ambient air quality standard (NAAQS). EPA stated in the direct final rule that if EPA received adverse comments by October 25, 2017, the rule would be withdrawn and not take effect. EPA subsequently received an adverse comment. EPA will address the comment received in a subsequent final action based upon the proposed action also published on September 25, 2017. EPA will not institute a second comment period on this action.

DATES:

As of as of November 17, 2017, the direct final rule published at 82 FR 44522 on September 25, 2017 is withdrawn.

FOR FURTHER INFORMATION CONTACT:

Sara Calcinore, (215) 814-2043, or by email at [email protected].

SUPPLEMENTARY INFORMATION:

On May 21, 2012, the Philadelphia-Wilmington-Atlantic City area was designated as marginal nonattainment for the 2008 8-hour ozone NAAQS. 77 FR 30088. The Philadelphia-Wilmington-Atlantic City nonattainment area is comprised of Cecil County in Maryland, as well as counties in Delaware, New Jersey, and Pennsylvania. Under section 172(c)(3) of the Clean Air Act (CAA), Maryland is required to submit a comprehensive, accurate, and current inventory of actual emissions from all sources of the relevant pollutants, i.e. the ozone precursors nitrogen oxides (NOX) and volatile organic compounds (VOCs), in its marginal nonattainment area, i.e., the Maryland portion of the Philadelphia-Wilmington-Atlantic City nonattainment area. On January 19, 2017, the State of Maryland, through the Maryland Department of the Environment (MDE), submitted a formal revision (state implementation plan (SIP) # 16-15) to its SIP. The SIP revision consists of the 2011 base year inventory for the Maryland portion of the Philadelphia-Wilmington-Atlantic City nonattainment area for the 2008 8-hour ozone NAAQS.

EPA approved Maryland's 2011 base year inventory for the Maryland portion of the Philadelphia-Wilmington-Atlantic City nonattainment area for the 2008 8-hour ozone NAAQS in the direct final rule published on September 25, 2017 (82 FR 44522). In this direct final rule, we stated that if we received adverse comment by October 25, 2017, the rule would be withdrawn and not take effect. EPA subsequently received an adverse comment. On September 25, 2017 (82 FR 44522), EPA simultaneously proposed to approve Maryland's 2011 base year inventory for the Maryland portion of the Philadelphia-Wilmington-Atlantic City nonattainment area for the 2008 8-hour ozone NAAQS. EPA will address the comment received in a subsequent final action based upon this proposed action and will not institute a second comment period on this action.

As a result of the comment received, EPA is withdrawing the direct final rule approving Maryland's 2011 base year inventory for the Maryland portion of the Philadelphia-Wilmington-Atlantic City nonattainment area for the 2008 8-hour ozone NAAQS.

List of Subjects in 40 CFR Part 52

Environmental protection, Air pollution control, Incorporation by reference, Nitrogen dioxide, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds.

Dated: November 3, 2017. Cosmo Servidio, Regional Administrator, Region III. Accordingly, the amendment to § 52.1070(e) published on September 25, 2017 (82 FR 44522), which were to become effective November 24, 2017, is withdrawn.
[FR Doc. 2017-24885 Filed 11-16-17; 8:45 am] BILLING CODE 6560-50-P
ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R07-OAR-2017-0477; FRL-9970-97-Region 7] Air Quality Implementation Plans; Nebraska; Infrastructure SIP Requirements for the 2010 Nitrogen Dioxide and Sulfur Dioxide and the 2012 Fine Particulate Matter National Ambient Air Quality Standards; Withdrawal AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Withdrawal of direct final rule.

SUMMARY:

Due to adverse comments, the Environmental Protection Agency (EPA) is withdrawing the direct final rule Approval of Nebraska Air Quality Implementation Plans; Infrastructure SIP Requirements for the 2010 Nitrogen Dioxide and Sulfur Dioxide and the 2012 Fine Particulate Matter National Ambient Air Quality Standards, published in the Federal Register on September 20, 2017. The direct final rule approved elements of a State Implementation Plan (SIP) submission from the State of Nebraska addressing the applicable requirements of Clean Air Act (CAA) section 110 for the 2010 Nitrogen Dioxide (NO2) and Sulfur Dioxide (SO2) National Ambient Air Quality Standards (NAAQS), and the 2012 Fine Particulate Matter (PM2.5) NAAQS. Section 110 of the CAA requires that each state adopt and submit a SIP to support implementation, maintenance, and enforcement of each new or revised NAAQS promulgated by EPA. These SIPs are commonly referred to as “infrastructure” SIPs.

DATES:

As of November 17, 2017, the direct final rule published at 82 FR 43848, September 20, 2017, is withdrawn.

FOR FURTHER INFORMATION CONTACT:

Gregory Crable, Environmental Protection Agency, Air Planning and Development Branch, 11201 Renner Boulevard, Lenexa, Kansas 66219 at (913) 551-7391, or by email at [email protected]

SUPPLEMENTARY INFORMATION:

Due to adverse comments, EPA is withdrawing the direct final rule to approve three Infrastructure SIPs submitted by the State of Nebraska pertaining to the 2010 NO2 and SO2 NAAQS and the 2012 PM2.5 NAAQS. In the direct final rule published in the Federal Register on September 20, 2017, (82 FR 43848), we stated that if we received adverse comment by Octber 20, 2017, the rule would be withdrawn and not take effect. EPA received adverse comments. EPA will address those comments in a subsequent final action based upon the proposed action also published in the Federal Register on September 20, 2017 (82 FR 43926). EPA will not institute a second comment period on this action.

List of Subjects in 40 CFR Part 52

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

Dated: November 8, 2017. Cathy Stepp, Acting Regional Administrator, Region 7. PART 52—APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS Accordingly, the direct final rule amending 40 CFR 52.1420 published in the Federal Register on September 20, 2017 (82 FR 43848), is withdrawn.
[FR Doc. 2017-24893 Filed 11-16-17; 8:45 am] BILLING CODE 6560-50-P
ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R07-OAR-2017-0208; FRL-9970-99-Region 7] State of Iowa; Elements of the Infrastructure SIP Requirements for the 2010 Nitrogen Dioxide National Ambient Air Quality Standard (NAAQS) Withdrawal AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Withdrawal of direct final rule.

SUMMARY:

Due to an adverse comment, the Environmental Protection Agency (EPA) is withdrawing the direct final rule for Approval of Implementation Plans; State of Iowa; Elements of the Infrastructure SIP Requirements for the 2010 Nitrogen Dioxide National Ambient Air Quality Standard (NAAQS) published in the Federal Register on September 20, 2017. Infrastructure SIPs address the applicable requirements of Clean Air Act (CAA) section 110, which requires that each state adopt and submit a SIP for the implementation, maintenance, and enforcement of each new or revised NAAQS promulgated by the EPA. These SIPs are commonly referred to as “infrastructure” SIPs. The infrastructure requirements are designed to ensure that the structural components of each state's air quality management program are adequate to meet the state's responsibilities under the CAA.

DATES:

The direct final rule published at 82 FR 43846, September 20, 2017, is withdrawn effective November 17, 2017.

FOR FURTHER INFORMATION CONTACT:

Heather Hamilton, Environmental Protection Agency, Air Planning and Development Branch, 11201 Renner Boulevard, Lenexa, Kansas 66219 at (913) 551-7039, or by email at [email protected]

SUPPLEMENTARY INFORMATION:

Due to an adverse comment, EPA is withdrawing the direct final rule to approve revisions to the Iowa State Implementation Plan (SIP). In the direct final rule published on September 20, 2017, (82 FR 43846), we stated that if we received adverse comment by October 20, 2017, the rule would be withdrawn and not take effect. EPA received an adverse comment. EPA will address the comment in a subsequent final action based upon the proposed action also published on September 20, 2017. EPA will not institute a second comment period on this action.

List of Subjects in 40 CFR Part 52

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

Dated: November 7, 2017. Cathy Stepp, Acting Regional Administrator, Region 7. PART 52—APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS Accordingly, the amendment to 40 CFR 52.820(e) published in the Federal Register on September 20, 2017, (82 FR 43846) is withdrawn effective November 17, 2017.
[FR Doc. 2017-24891 Filed 11-16-17; 8:45 am] BILLING CODE 6560-50-P
ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R07-OAR-2017-0267; FRL-9970-98-Region 7] Approval of Implementation Plans; State of Iowa; Elements of the Infrastructure SIP Requirements for the 2010 Sulfur Dioxide National Ambient Air Quality Standard (NAAQS); Withdrawal AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Withdrawal of direct final rule.

SUMMARY:

Due to an adverse comment, the Environmental Protection Agency (EPA) is withdrawing the direct final rule for Approval of Implementation Plans; State of Iowa; Elements of the Infrastructure SIP Requirements for the 2010 Sulfur Dioxide National Ambient Air Quality Standard (NAAQS) published in the Federal Register on September 29, 2017. Infrastructure SIPs address the applicable requirements of Clean Air Act (CAA) section 110, which requires that each state adopt and submit a SIP for the implementation, maintenance, and enforcement of each new or revised NAAQS promulgated by the EPA. These SIPs are commonly referred to as “infrastructure” SIPs. The infrastructure requirements are designed to ensure that the structural components of each state's air quality management program are adequate to meet the state's responsibilities under the CAA.

DATES:

As of November 17, 2017, the direct final rule published on September 29, 2017 (82 FR 45497), is withdrawn.

FOR FURTHER INFORMATION CONTACT:

Heather Hamilton Environmental Protection Agency, Air Planning and Development Branch, 11201 Renner Boulevard, Lenexa, Kansas 66219 at 913-551-7039, or by email at [email protected]

SUPPLEMENTARY INFORMATION:

Due to an adverse comment, EPA is withdrawing the direct final rule to approve revisions to the Iowa State Implementation Plan (SIP). In the direct final rule published on September 29, 2017, (82 FR 45497), we stated that if we received adverse comment by October 30, 2017, the rule would be withdrawn and not take effect. EPA received an adverse comment. EPA will address the comment in a subsequent final action based upon the proposed action also published on September 29, 2017 (82 FR 45550). EPA will not institute a second comment period on this action.

List of Subjects in 40 CFR Part 52

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

Dated: November 8, 2017. Cathy Stepp, Acting Regional Administrator, Region 7. PART 52—APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS Accordingly, the direct final rule amending 40 CFR 52.820 published in the Federal Register on September 29, 2017 (82 FR 45497), is withdrawn.
[FR Doc. 2017-24903 Filed 11-16-17; 8:45 am] BILLING CODE 6560-50-P
ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R07-OAR-2017-0512; FRL-9971-00-Region 7] Approval of Kansas Air Quality State Implementation Plans; Construction Permits and Approvals Program; Withdrawal AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Withdrawal of direct final rule.

SUMMARY:

Due to an adverse comment, the Environmental Protection Agency (EPA) is withdrawing the direct final rule for Approval of Kansas Air Quality State Implementation Plans; Construction Permits and Approvals Program, published in the Federal Register on September 21, 2017. Kansas's SIP revisions included revisions to Kansas' construction permit rules. Specifically, these revisions implemented the revised National Ambient Air Quality Standard (NAAQS) for fine particulate matter; clarified and refined applicable criteria for sources subject to the construction permitting program; updated the construction permitting program fee structure and schedule; and made minor revisions and corrections.

DATES:

As of November 17, 2017, the direct final rule published at 82 FR 44103, on September 21, 2017, is withdrawn.

FOR FURTHER INFORMATION CONTACT:

Deborah Bredehoft, Environmental Protection Agency, Air Planning and Development Branch, 11201 Renner Boulevard, Lenexa, Kansas 66219 at (913) 551-7164, or by email at [email protected].

SUPPLEMENTARY INFORMATION:

Due to adverse comments, EPA is withdrawing the direct final rule to approve revisions to the Kansas State Implementation Plan (SIP). In the direct final rule published on September 21, 2017 (82 FR 44103), we stated that if we received adverse comment by October 23, 2017, the rule would be withdrawn and not take effect. EPA received adverse comments. EPA will address the comments in a subsequent action.

List of Subjects in 40 CFR Part 52

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

Dated: November 8, 2017. Cathy Stepp, Acting Regional Administrator, Region 7. PART 52—APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS Accordingly, the amendment to 40 CFR 52.870 published in the Federal Register on September 21, 2017 (82 FR 44103), on page 44105 is withdrawn.
[FR Doc. 2017-24894 Filed 11-16-17; 8:45 am] BILLING CODE 6560-50-P
ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R03-OAR-2017-0394; FRL-9970-69-Region 3] Approval and Promulgation of Air Quality Implementation Plans; Maryland; Direct Final Rule for the Approval of an Alternative Volatile Organic Compound Emission Standard; Withdrawal AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Withdrawal of direct final rule.

SUMMARY:

Due to adverse comments received, the Environmental Protection Agency (EPA) is withdrawing the August 28, 2017 direct final rule that approved a revision to the Maryland state implementation plan (SIP) to incorporate by reference a Maryland Department of the Environment (MDE) order that establishes an alternative volatile organic compound (VOC) emission standard for National Gypsum Company (NGC) to ensure that it remains a minor VOC source. EPA stated in the direct final rule that if EPA received adverse comments by September 27, 2017, the rule would be withdrawn and not take effect. EPA subsequently received one adverse comment. EPA will address the comment received in a subsequent final action based upon the proposed action also published on August 28, 2017. EPA will not institute a second comment period on this action.

DATES:

As of November 17, 2017, the direct final rule published at 82 FR 40715, August 28, 2017, is withdrawn.

FOR FURTHER INFORMATION CONTACT:

Gregory Becoat, (215) 814 2036, or by email at [email protected]

SUPPLEMENTARY INFORMATION:

On June 24, 2016, MDE submitted a formal revision to the Maryland SIP. The SIP revision consisted of a request to incorporate by reference a MDE departmental order that establishes an alternative VOC emission standard for NGC as it appears in the permit-to-construct conditions issued by MDE in order to ensure that it remains a minor stationary source of VOCs. The alternative VOC emissions limit of 195 pounds per operating day with at least a 99% overall VOC control efficiency will achieve a stringent emissions discharge reduction and is more stringent than any established standard for reasonably available control technology (RACT) for major stationary sources of VOCs in Code of Maryland Regulations (COMAR) 26.11.19. Under COMAR 26.11.06.06E—“Exceptions,” a source may request an exception to a VOC emissions limit from MDE if the source is not subject to new source review (NSR) and if the source is unable to comply with COMAR 26.11.06.06B—“Control of VOC from Installations.” In the direct final rule published on August 28, 2017 (82 FR 40715), EPA stated that if EPA received adverse comments by September 27, 2017, the rule would be withdrawn and not take effect. EPA subsequently received one adverse comment from an anonymous commenter.

As a result of the comment received, EPA is withdrawing the direct final rule approving the revision to the Maryland SIP that incorporates by reference a MDE order establishing a VOC emission standard for NGC.

List of Subjects in 40 CFR Part 52

Environmental protection, Air pollution control, Incorporation by reference, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds.

Dated: October 31, 2017. Cosmo Servidio, Regional Administrator, Region III. Accordingly, the amendment to § 52.1070(d) published on August 28, 2017 (82 FR 40715), which were to become effective November 27, 2017, are withdrawn.
[FR Doc. 2017-24889 Filed 11-16-17; 8:45 am] BILLING CODE 6560-50-P
FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 73 [MB Docket No. 17-187; RM-11792; DA 17-1062] Television Broadcasting Services; Anchorage, Alaska AGENCY:

Federal Communications Commission.

ACTION:

Final rule.

SUMMARY:

The Commission grants the request by Gray Television License, LLC (Gray) to substitute channel 7 for channel 5 for station KYES-TV, Anchorage, Alaska. Gray filed comments reaffirming its interest in the proposed channel substitution and stating that if the proposal is granted, it will promptly file an application for the facilities specified in the rulemaking petition and construct the station. As Gray explained in its petition, the antenna currently used by KYES-TV is a repurposed analog antenna the previous station owner built which provides an inefficient signal. In addition, the current remote transmission site does not have a generator and KYES-TV goes silent when there is a power outage. By moving to sister station KTUU's location, and operating with an existing modern broadband antenna on a high-VHF channel, the station will be able to deliver an improved signal. Gray will also add the KYES-TV signal to the translator network used by KTUU, which will reduce most of the loss of service that would result from the proposed move, which will serve the public interest.

DATES:

This rule is effective December 18, 2017.

FOR FURTHER INFORMATION CONTACT:

Joyce Bernstein, [email protected], Media Bureau, (202) 418-1647.

SUPPLEMENTARY INFORMATION:

This is a synopsis of the Commission's Order, MB Docket No. 17-187, adopted October 31, 2017, and released October 31, 2017. The full text of this document is available for public inspection and copying during normal business hours in the FCC's Reference Information Center at Portals II, CY-A257, 445 12th Street SW., Washington, DC 20554. This document will also be available via ECFS (http://fjallfoss.fcc.gov/ecfs/). 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 & Governmental Affairs Bureau at 202-418-0530 (voice), 202-418-0432 (tty).

This document does not contain information collection requirements subject to the Paperwork Reduction Act of 1995, Public Law 104-13. In addition, therefore, it does not contain any information collection burden “for small business concerns with fewer than 25 employees,” pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4). Provisions of the Regulatory Flexibility Act of 1980, see 5 U.S.C. 601-612, do not apply to this proceeding.

The Commission will send a copy of this Report and Order in a report to be sent to Congress and the Government Accountability Office pursuant to the Congressional Review Act, see 5 U.S.C. 801(a)(1)(A).

List of Subjects in 47 CFR Part 73

Television.

Federal Communications Commission. Barbara A. Kreisman, Chief, Video Division, Media Bureau. Final Rule

For the reasons discussed in the preamble, the Federal Communications Commission amends 47 CFR part 73 as follows:

PART 73—RADIO BROADCAST SERVICES 1. The authority citation for part 73 continues to read as follows: Authority:

47 U.S.C. 154, 303, 309, 310, 334 336, and 339.

§ 73.622 [Amended]
2. Section 73.622(i), the Post-Transition Table of DTV Allotments under Alaska is amended by removing channel 5 and adding channel 7 at Anchorage.
[FR Doc. 2017-24944 Filed 11-16-17; 8:45 am] BILLING CODE 6712-01-P
82 221 Friday, November 17, 2017 Proposed Rules DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2017-1022; Product Identifier 2017-NM-098-AD] RIN 2120-AA64 Airworthiness Directives; The Boeing Company Airplanes AGENCY:

Federal Aviation Administration (FAA), DOT.

ACTION:

Notice of proposed rulemaking (NPRM).

SUMMARY:

We propose to adopt a new airworthiness directive (AD) for certain The Boeing Company Model 787-8 and 787-9 airplanes. This proposed AD was prompted by reports of failures of the lip heater assemblies of the inlet ice protection system of the cabin air compressor (CAC) due to chafing. This proposed AD would require changing the airplane electrical connectors and the routes of certain wire bundles, and installing new or modified left and right CAC inlet duct assemblies. We are proposing this AD to address the unsafe condition on these products.

DATES:

We must receive comments on this proposed AD by January 2, 2018.

ADDRESSES:

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

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

Fax: 202-493-2251.

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

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

For service information identified in this NPRM, contact Boeing Commercial Airplanes, Attention: Contractual & Data Services (C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-5600; telephone 562-797-1717; Internet https://www.myboeingfleet.com. You may view this referenced service information at the FAA, Transport Standards Branch, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221. It is also available on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-1022.

Examining the AD Docket

You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-1022; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this NPRM, the regulatory evaluation, any comments received, and other information. The street address for the Docket Office (phone: 800-647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT:

Joe Salemeh, Aerospace Engineer, Systems and Equipment Section, FAA, Seattle ACO Branch, 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-6454; fax: 425-917-6590; email: [email protected]

SUPPLEMENTARY INFORMATION:

Comments Invited

We invite you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2017-1022; Product Identifier 2017-NM-098-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this NPRM. We will consider all comments received by the closing date and may amend this NPRM because of those comments.

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

Discussion

We have received reports of failures of the inlet lip heater assemblies of the inlet ice protection system of the CAC due to chafing of the CAC inlet ice protection system (CIPS) inlet lip heater wire harness against adjacent structures. The damage to the wires caused the CIPS lip heater to set a fault. This condition, if not corrected, could result in an electrical short and potential loss of functions essential for safe flight of the airplane.

Related Service Information Under 1 CFR Part 51

We reviewed Boeing Alert Service Bulletin B787-81205-SB300019-00, Issue 001, dated March 22, 2017. The service information describes procedures for changing the airplane electrical connectors and the routes of certain wire bundles, and installing new or modified left and right CAC inlet duct assemblies. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

FAA's Determination

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

Proposed AD Requirements

This proposed AD would require accomplishment of the actions identified as “RC” (required for compliance) in the Accomplishment Instructions of Boeing Alert Service Bulletin B787-81205-SB300019-00, Issue 001, dated March 22, 2017, described previously, except for any differences identified as exceptions in the regulatory text of this proposed AD.

For information on the procedures and compliance times, see this service information at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-1022.

Costs of Compliance

We estimate that this proposed AD affects 66 airplanes of U.S. registry. We estimate the following costs to comply with this proposed AD:

Estimated Costs for Required Actions Action Labor cost Parts cost Cost per
  • product
  • Cost on U.S.
  • operators
  • Change and installation 20 work-hours × $85 per hour = $1,700 $32,937 $34,637 $2,286,042

    According to the manufacturer, all of the costs of this proposed AD may be covered under warranty, thereby reducing the cost impact on affected individuals. We do not control warranty coverage for affected individuals. As a result, we have included all costs in our cost estimate.

    Authority for This Rulemaking

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

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

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

    Regulatory Findings

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

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

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

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

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

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

    List of Subjects in 14 CFR Part 39

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

    The Proposed Amendment

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

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

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

    § 39.13 [Amended]

    2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD): The Boeing Company: Docket No. FAA-2017-1022; Product Identifier 2017-NM-098-AD. (a) Comments Due Date

    We must receive comments by January 2, 2018.

    (b) Affected ADs

    None.

    (c) Applicability

    This AD applies to The Boeing Company Model 787-8 and 787-9 airplanes, certificated in any category, as identified in Boeing Alert Service Bulletin B787-81205-SB300019-00, Issue 001, dated March 22, 2017.

    (d) Subject

    Air Transport Association (ATA) of America Code 30, Ice/Rain protection system wiring.

    (e) Unsafe Condition

    This AD was prompted by reports of failures of the Cabin Air Compressor (CAC) inlet ice protection system (CIPS) inlet lip heater assemblies due to chafing of the CIPS inlet lip heater wire harness against adjacent structures. We are issuing this AD to prevent any damage to the CIPS inlet lip heater wire bundle, which could cause an electrical short and potential loss of functions essential for safe flight of the airplane.

    (f) Compliance

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

    (g) Required Actions

    Within 36 months after the effective date of this AD, do all applicable actions identified as “RC” (required for compliance) in, and in accordance with, the Accomplishment Instructions of Boeing Alert Service Bulletin B787-81205-SB300019-00, Issue 001, dated March 22, 2017.

    (h) Alternative Methods of Compliance (AMOCs)

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

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

    (3) An AMOC that provides an acceptable level of safety may be used for any repair, modification, or alteration required by this AD if it is approved by the Boeing Commercial Airplanes Organization Designation Authorization (ODA) that has been authorized by the Manager, Seattle ACO Branch, to make those findings. To be approved, the repair method, modification deviation, or alteration deviation must meet the certification basis of the airplane, and the approval must specifically refer to this AD.

    (4) For service information that contains steps that are labeled as RC, the provisions of paragraphs (h)(4)(i) and (h)(4)(ii) of this AD apply.

    (i) The steps labeled as RC, including substeps under an RC step and any figures identified in an RC step, must be done to comply with the AD. If a step or substep is labeled “RC Exempt,” then the RC requirement is removed from that step or substep. An AMOC is required for any deviations to RC steps, including substeps and identified figures.

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

    (i) Related Information

    (1) For more information about this AD, contact Joe Salemeh, Aerospace Engineer, Systems and Equipment Section, FAA, Seattle ACO Branch, 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-6454; fax: 425-917-6590; email: [email protected]

    (2) For service information identified in this AD, contact Boeing Commercial Airplanes, Attention: Contractual & Data Services (C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-5600; telephone 562-797-1717; Internet https://www.myboeingfleet.com. You may view this referenced service information at the FAA, Transport Standards Branch, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.

    Issued in Renton, Washington, on November 3, 2017. Jeffrey E. Duven, Director, System Oversight Division, Aircraft Certification Service.
    [FR Doc. 2017-24809 Filed 11-16-17; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2017-1025; Product Identifier 2017-NM-137-AD] RIN 2120-AA64 Airworthiness Directives; Bombardier, Inc., Airplanes AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    We propose to adopt a new airworthiness directive (AD) for certain Bombardier, Inc., Model CL-600-2C10 (Regional Jet Series 700, 701, & 702), CL-600-2D15 (Regional Jet Series 705), CL-600-2D24 (Regional Jet Series 900), and CL-600-2E25 (Regional Jet Series 1000) airplanes. This proposed AD was prompted by several incidents of electrical shorting and sparks caused by de-icing fluid leaks between flight deck windshields and side windows. This proposed AD would require water spray tests and general visual inspections for water in the flight compartment, and water removal and sealant application if necessary. We are proposing this AD to address the unsafe condition on these products.

    DATES:

    We must receive comments on this proposed AD by January 2, 2018.

    ADDRESSES:

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

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

    Fax: 202-493-2251.

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

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

    For service information identified in this NPRM, contact Bombardier, Inc., 400 Côte Vertu Road West, Dorval, Québec H4S 1Y9, Canada; Widebody Customer Response Center North America toll-free telephone 1-866-538-1247 or direct-dial telephone 1-514-855-2999; fax 514-855-7401; email [email protected]; Internet http://www.bombardier.com. You may view this service information at the FAA, Transport Standards Branch, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.

    Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-1025; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this NPRM, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone 800-647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

    FOR FURTHER INFORMATION CONTACT:

    Steven Dzierzynski, Aerospace Engineer, Avionics and Administrative Services Section, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-7367; fax 516-794-5531.

    SUPPLEMENTARY INFORMATION:

    Comments Invited

    We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2017-1025; Product Identifier 2017-NM-137-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this NPRM. We will consider all comments received by the closing date and may amend this NPRM based on those comments.

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

    Discussion

    Transport Canada Civil Aviation (TCCA), which is the aviation authority for Canada, has issued Canadian Airworthiness Directive CF-2017-28, dated August 23, 2017 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Bombardier, Inc., Model CL-600-2C10 (Regional Jet Series 700, 701, & 702), CL-600-2D15 (Regional Jet Series 705), CL-600-2D24 (Regional Jet Series 900), and CL-600-2E25 (Regional Jet Series 1000) airplanes. The MCAI states:

    Several incidents of electrical shorting and sparks have been reported in the cockpit of CL-600-2C10 and CL-600-2D24 aeroplanes. De-icing fluid can leak between the windshields and side windows, leading to possible damage to the cockpit floodlight wires and electrical connections. If not corrected, this condition may result in a flight compartment fire.

    This [Canadian] AD is issued to mandate a water spray test and [general visual] inspection for evidence of fluid ingress into the flight compartment. It also provides mandatory instructions for sealant application if required.

    You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-1025.

    Related Service Information Under 1 CFR Part 51

    Bombardier, Inc., has issued Service Bulletin 670BA-56-003, Revision A, dated April 13, 2016. This service information describes procedures for doing water spray tests on the flight deck windows, doing general visual inspections for water in the flight compartment, removing water, and applying sealant to the flight deck windows. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

    FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all pertinent information and determined an unsafe condition exists and is likely to exist or develop on other products of these same type designs.

    Costs of Compliance

    We estimate that this proposed AD affects 543 airplanes of U.S. registry.

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

    Estimated Costs Action Labor cost Parts cost Cost per
  • product
  • Cost on
  • U.S. operators
  • Spray tests and inspections 2 work-hours × $85 per hour = $170 $0 $170 $92,310

    We estimate the following costs to do any necessary water removal and sealant application that would be required based on the results of the proposed inspection. We have no way of determining the number of airplanes that might need this water removal and sealant application:

    On-Condition Costs Action Labor cost Parts cost Cost per
  • product
  • Water removal and sealant application 4 work-hours × $85 per hour = $340 $308 $648
    Authority for This Rulemaking

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

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

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

    Regulatory Findings

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

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

    1. Is not a “significant regulatory action” under Executive Order 12866;

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

    3. Will not affect intrastate aviation in Alaska; and

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

    List of Subjects in 14 CFR Part 39

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

    The Proposed Amendment

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

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

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

    § 39.13 [Amended]
    2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD): Bombardier, Inc.: Docket No. FAA-2017-1025; Product Identifier 2017-NM-137-AD. (a) Comments Due Date

    We must receive comments by January 2, 2018.

    (b) Affected ADs

    None.

    (c) Applicability

    This AD applies to the airplanes identified in paragraphs (c)(1), (c)(2), and (c)(3) of this AD, certificated in any category.

    (1) Bombardier, Inc., Model CL-600-2C10 (Regional Jet Series 700, 701, & 702) airplanes, serial numbers 10003 through 10342 inclusive.

    (2) Bombardier, Inc., Model CL-600-2D15 (Regional Jet Series 705) and Model CL-600-2D24 (Regional Jet Series 900) airplanes, serial numbers 15001 through 15367 inclusive.

    (3) Bombardier, Inc., Model CL-600-2E25 (Regional Jet Series 1000) airplanes, serial numbers 19001 through 19041 inclusive.

    (d) Subject

    Air Transport Association (ATA) of America Code 56, Windows.

    (e) Reason

    This AD was prompted by several incidents of electrical shorting and sparks caused by de-icing fluid leaks between flight deck windshields and side windows. We are issuing this AD to detect and correct de-icing fluid entering the flight deck, which could damage the flight deck floodlight wires and electrical connections, and ultimately could lead to a fire in the flight compartment.

    (f) Compliance

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

    (g) Left Flight Deck Windshield and Side Window Spray Test, Inspection, Water Removal and Sealant Application

    For airplanes on which a left flight deck windshield or a left flight deck side window was replaced as specified in Bombardier Aircraft Maintenance Manual (AMM) task 56-11-01-400-801, Revision 48, dated March 25, 2015, or any previous revision of that task; or Bombardier AMM task 56-12-01-400-801, Revision 48, dated March 25, 2015, or any previous revision of that task: At the applicable time specified in paragraph (g)(1) or (g)(2) of this AD, perform a water spray test and do a general visual inspection of the left flight deck windshield and left flight deck side window for evidence of water ingress into the flight deck, in accordance with Part A of the Accomplishment Instructions of Bombardier Service Bulletin 670BA-56-003, Revision A, dated April 13, 2016. If water is found in the flight compartment: Before further flight, remove the water, and apply sealant on the left flight deck windows in accordance with Part C of the Accomplishment Instructions of Bombardier Service Bulletin 670BA-56-003, Revision A, dated April 13, 2016.

    (1) For airplanes on which Bombardier in-service ModSum IS67033110181 has not been incorporated: Within 2,500 flight hours after the effective date of this AD.

    (2) For airplanes on which Bombardier in-service ModSum IS67033110181 has been incorporated: Within 6,600 flight hours after the effective date of this AD.

    (h) Right Flight Deck Windshield and Side Window Spray Test, Inspection, Water Removal and Sealant Application

    For airplanes on which a right flight deck windshield or a right flight deck side window was replaced as specified in Bombardier AMM task 56-11-01-400-801, Revision 48, dated March 25, 2015, or any previous revision of that task; or Bombardier AMM task 56-12-01-400-801, Revision 48, dated March 25, 2015, or any previous revision of that task: At the applicable time specified in paragraph (h)(1) or (h)(2) of this AD, perform a water spray test and do a general visual inspection of the right flight deck windshield and right flight deck side window for evidence of water ingress into the flight deck, in accordance with Part B of the Accomplishment Instructions of Bombardier Service Bulletin 670BA-56-003, Revision A, dated April 13, 2016. If water is found in the flight compartment: Before further flight, remove the water, and apply sealant on the right flight deck windows in accordance with Part D of the Accomplishment Instructions of Bombardier Service Bulletin 670BA-56-003, Revision A, dated April 13, 2016.

    (1) For airplanes on which Bombardier in-service ModSum IS67033110181 has not been incorporated: Within 2,500 flight hours after the effective date of this AD.

    (2) For airplanes on which Bombardier in-service ModSum IS67033110181 has been incorporated: Within 6,600 flight hours after the effective date of this AD.

    (i) Credit for Previous Actions

    (1) This paragraph provides credit for actions required by paragraph (g) of this AD, if those actions were performed before the effective date of this AD using the service information specified in paragraphs (i)(1)(i), (i)(1)(ii), or (i)(1)(iii) of this AD; provided that the left flight deck side window or left flight deck windshield have not been subsequently replaced as specified in Bombardier AMM task 56-11-01-400-801, Revision 48, dated March 25, 2015, or any previous revision of that task; or Bombardier AMM task 56-12-01-400-801, Revision 48, dated March 25, 2015, or any previous revision of that task.

    (i) Bombardier Alert Service Bulletin A670BA-56-002, dated January 7, 2008.

    (ii) Bombardier Alert Service Bulletin A670BA-56-002, Revision A, dated February 26, 2008.

    (iii) Part A and Part C, as applicable, of the Accomplishment Instructions of Bombardier Service Bulletin 670BA-56-003, dated May 28, 2015.

    (2) This paragraph provides credit for actions required by paragraph (h) of this AD, if those actions were performed before the effective date of this AD using the service information specified in paragraphs (i)(2)(i), (i)(2)(ii), or (i)(2)(iii) of this AD; provided that the right flight deck side window or right flight deck windshield have not been subsequently replaced as specified in Bombardier AMM task 56-11-01-400-801, Revision 48, dated March 25, 2015, or any previous revision of that task; or Bombardier AMM task 56-12-01-400-801, Revision 48, dated March 25, 2015, or any previous revision of that task.

    (i) Bombardier Alert Service Bulletin A670BA-56-002, dated January 7, 2008.

    (ii) Bombardier Alert Service Bulletin A670BA-56-002, Revision A, dated February 26, 2008.

    (iii) Part B and Part D, as applicable, of the Accomplishment Instructions of Bombardier Service Bulletin 670BA-56-003, dated May 28, 2015.

    (j) Parts Installation Limitations

    (1) As of the effective date of this AD, no person may install on any airplane a left or right flight deck windshield as specified in Bombardier AMM task 56-11-01-400-801, Revision 48, dated March 25, 2015, or any previous revision of that task.

    (2) As of the effective date of this AD, no person may install on any airplane a left or right flight deck side window as specified in Bombardier AMM task 56-12-01-400-801, Revision 48, dated March 25, 2015, or any previous revision of that task.

    (k) Other FAA AD Provisions

    The following provisions also apply to this AD:

    (1) Alternative Methods of Compliance (AMOCs): The Manager, New York ACO Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the certification office, send it to ATTN: Program Manager, Continuing Operational Safety, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-7300; fax 516-794-5531. Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.

    (2) Contacting the Manufacturer: For any requirement in this AD to obtain corrective actions from a manufacturer, the action must be accomplished using a method approved by the Manager, New York ACO Branch, FAA; or Transport Canada Civil Aviation (TCCA); or Bombardier, Inc.'s TCCA Design Approval Organization (DAO). If approved by the DAO, the approval must include the DAO-authorized signature.

    (l) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information (MCAI) Canadian Airworthiness Directive CF-2017-28, dated August 23, 2017, for related information. This MCAI may be found in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-1025.

    (2) For more information about this AD, contact Steven Dzierzynski, Aerospace Engineer, Avionics and Administrative Services Section, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-7367; fax 516-794-5531.

    (3) For service information identified in this AD, contact Bombardier, Inc., 400 Côte Vertu Road West, Dorval, Québec H4S 1Y9, Canada; Widebody Customer Response Center North America toll-free telephone 1-866-538-1247 or direct-dial telephone 1-514-855-2999; fax 514-855-7401; email [email protected]; Internet http://www.bombardier.com. You may view this service information at the FAA, Transport Standards Branch, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.

    Issued in Renton, Washington, on November 8, 2017. Dionne Palermo, Acting Director, System Oversight Division, Aircraft Certification Service.
    [FR Doc. 2017-24814 Filed 11-16-17; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 110 [Docket Number USCG-2016-0916] RIN 1625-AA01 Anchorages; Captain of the Port Puget Sound Zone, WA AGENCY:

    Coast Guard, DHS.

    ACTION:

    Notification of intent to withdraw proposed rule; request for comments.

    SUMMARY:

    The Coast Guard intends to withdraw the proposed anchorage rule entitled “Anchorages; Captain of the Port Puget Sound Zone, WA” that we published on February 10, 2017. The Coast Guard does not currently plan to pursue this rulemaking and consequently does not intend to schedule tribal consultation on the proposed rule. Given the Coast Guard's intent to withdraw, in this request for comment, the Coast Guard is asking if withdrawal is appropriate and if tribal consultation specific to this rulemaking is still appropriate.

    DATES:

    Your comments and related material must reach the Coast Guard on or before January 16, 2018.

    ADDRESSES:

    You may submit comments identified by docket number USCG-2016-0916 using the Federal portal at http://www.regulations.gov. See the “Public Participation and Request for Comments” portion of the SUPPLEMENTARY INFORMATION section for further instructions on submitting comments.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions about this notification of intent, call or email LCDR Christina Sullivan, U.S. Coast Guard Sector Puget Sound; telephone 206-217-6042, email [email protected]

    SUPPLEMENTARY INFORMATION: I. Table of Abbreviations FR Federal Register NPRM Notice of Proposed Rulemaking II. Background and Purpose

    We published a notice of proposed rulemaking (NPRM) in the Federal Register on February 10, 2017 (82 FR 10313), entitled “Anchorages; Captain of the Port Puget Sound Zone, WA.” In the NPRM, we proposed the creation of several new anchorages, holding areas, and a non-anchorage area as well as the expansion of one existing general anchorage in the Puget Sound area, as detailed in the proposed regulatory text. The Coast Guard received input from a number of tribes expressing concern about the current rulemaking and based on that input, we intend to withdraw the proposed anchorage rule.

    Four months after publishing the NPRM, the Coast Guard provided notice of its intent to conduct a government to government consultation with the tribes on the proposed rulemaking. In that published notification of tribal consultation (82 FR 25207, June 1, 2017), the Coast Guard stated that it would post a written summary of the government to government tribal consultation to the docket, and that members of the public would have time to submit further comments between the posting of the summary of the tribal consultation and the closing of the comment period. The tribal consultation was postponed at the request of the participants, and has not been rescheduled.

    Because the Coast Guard published a notice of formal tribal government to government consultation on this proposed rule, the Coast Guard wants to ensure that tribal governments have an opportunity to indicate whether they believe tribal consultation is necessary in light of our intent to withdraw the proposed rule. Tribal governments that believe consultation on this proposed rule is necessary should comment in the docket, and may also contact the person in the FOR FURTHER INFORMATION CONTACT section of this preamble.

    Canceling tribal consultation on this specific proposed rule does not prevent other consultation from occurring. The Coast Guard supports a separate government to government consultation with the tribes regarding tribal treaty rights and broader issues of waterways usage outside of the rulemaking process. Accordingly, the Coast Guard will conduct outreach regarding the scope of a potential separate government to government consultation independently of this notification of intent and request for comment.

    If the Coast Guard decides to withdraw the proposed rule, we will issue a notification of withdrawal.

    III. Information Requested

    We are requesting comment from interested persons, particularly from tribal officials, tribal governments, tribal organizations, and tribal members on whether withdrawal is appropriate, and whether a government to government consultation on this anchorages rulemaking is desired in light of the Coast Guard's intent to withdraw from the rulemaking. Because the Coast Guard intends to withdraw from this rulemaking, the Coast Guard believes that tribal government to government consultation on this proposed anchorages rulemaking is no longer necessary.

    IV. Public Participation and Request for Comments

    We encourage you to submit comments through the Federal portal at http://www.regulations.gov. If your material cannot be submitted using http://www.regulations.gov, contact the person in the FOR FURTHER INFORMATION CONTACT section of this document for alternate instructions. In your submission, please include the docket number for this notification of intent and provide a reason for each suggestion or recommendation.

    We accept anonymous comments. All comments received will be posted without change to http://www.regulations.gov and will include any personal information you have provided. For more about privacy and the docket, visit http://www.regulations.gov/privacyNotice.

    Documents mentioned in this notification of intent as being available in the docket, and all public comments, will be in our online docket at http://www.regulations.gov and can be viewed by following that Web site's instructions.

    This document is issued under authority of 5 U.S.C. 552(a).

    Dated: November 9, 2017. David G. Throop, Rear Admiral, U.S. Coast Guard, Commander, Thirteenth Coast Guard District.
    [FR Doc. 2017-24942 Filed 11-16-17; 8:45 am] BILLING CODE 9110-04-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R09-OAR-2017-0573; FRL-9970-86-Region 9] Approval of California Air Plan Revisions, Mojave Desert Air Quality Management District AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Proposed rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is proposing to approve a revision to the Mojave Desert Air Quality Management District (MDAQMD) portion of the California State Implementation Plan (SIP). This revision concerns emissions of volatile organic compounds (VOCs) from marine and pleasure craft coating operations. We are proposing to approve a local rule to regulate these emission sources under the Clean Air Act (CAA or the Act). We are taking comments on this proposal and plan to follow with a final action.

    DATES:

    Any comments must arrive by December 18, 2017.

    ADDRESSES:

    Submit your comments, identified by Docket ID No. EPA-R09-OAR-2017-0573 at http://www.regulations.gov, or via email to Arnold Lazarus, Rulemaking Office at [email protected] For comments submitted at Regulations.gov, follow the online instructions for submitting comments. Once submitted, comments cannot be removed or edited from Regulations.gov. For either manner of submission, 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, please contact the person identified in the FOR FURTHER INFORMATION CONTACT section. For the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

    FOR FURTHER INFORMATION CONTACT:

    Arnold Lazarus, EPA Region IX, (415) 972-3024, [email protected]

    SUPPLEMENTARY INFORMATION:

    Throughout this document, “we,” “us” and “our” refer to the EPA.

    Table of Contents I. The State's Submittal A. What rule did the State submit? B. Are there other versions of this rule? C. What is the purpose of the submitted rule revision? II. The EPA's Evaluation and Action A. How is the EPA evaluating the rule? B. Does the rule meet the evaluation criteria? C. EPA Recommendations To Further Improve the Rule D. Public Comment and Proposed Action III. Incorporation by reference IV. Statutory and Executive Order Reviews I. The State's Submittal A. What rule did the State submit?

    Table 1 lists the rule addressed by this proposal with the date that it was adopted by the local air agency and submitted by the California Air Resources Board (CARB).

    Table 1—Submitted Rule Local agency Rule # Rule title Amended Submitted MDAQMD 1106 Marine and Pleasure Craft Coating Operations 10/24/2016 02/24/2017

    On August 2, 2017, the EPA determined that the submittal for MDAQMD Rule 1106 met the completeness criteria in 40 CFR part 51 Appendix V, which must be met before formal EPA review.

    B. Are there other versions of this rule?

    We approved an earlier version of Rule 1106 into the SIP on July 16, 2008 (73 FR 40754). The MDAQMD adopted revisions to the SIP-approved version on October 24, 2016 and CARB submitted them to us on February 24, 2017.

    C. What is the purpose of the submitted rule revision?

    VOCs help produce ground-level ozone, smog and particulate matter, which harm human health and the environment. Section 110(a) of the CAA requires states to submit regulations that control VOC emissions. Rule 1106 was revised primarily to implement reasonably available control technology (RACT) recommendations to strengthen the overall VOC capture and control efficiency from 85 to 90%, and to generally adopt more stringent VOC content limits for marine and pleasure craft coatings. The EPA's technical support document (TSD) has more information about this rule.

    II. The EPA's Evaluation and Action A. How is the EPA evaluating the rule?

    SIP rules must be enforceable (see CAA section 110(a)(2)), must not interfere with applicable requirements concerning attainment and reasonable further progress or other CAA requirements (see CAA section 110(l)), and must not modify certain SIP control requirements in nonattainment areas without ensuring equivalent or greater emissions reductions (see CAA section 193).

    Generally, SIP rules must require RACT for each category of sources covered by a Control Techniques Guidelines (CTG) document as well as each major source of VOCs in ozone nonattainment areas classified as moderate or above (see CAA section 182(b)(2)). The MDAQMD regulates an ozone nonattainment area classified as Severe for the 1997 and the 2008 8-Hour Ozone National Ambient Air Quality Standards (40 CFR 81.305). In addition, Rule 1106 regulates activities covered by two different CTGs: Control Techniques Guidelines for Shipbuilding and Ship Repair Operations (61 FR 44050), August 1996, and Control Techniques Guidelines for Miscellaneous Metal and Plastic Parts Coatings EPA-453/R-08-003, September 2008. Therefore, this rule must implement RACT.

    Guidance and policy documents that we use to evaluate enforceability, revision/relaxation and rule stringency requirements for the applicable criteria pollutants include the following:

    1. “State Implementation Plans; General Preamble for the Implementation of Title I of the Clean Air Act Amendments of 1990,” 57 FR 13498 (April 16, 1992); 57 FR 18070 (April 28, 1992).

    2. “Issues Relating to VOC Regulation Cutpoints, Deficiencies, and Deviations,” EPA, May 25, 1988 (the Bluebook, revised January 11, 1990).

    3. “Guidance Document for Correcting Common VOC & Other Rule Deficiencies,” EPA Region 9, August 21, 2001 (the Little Bluebook).

    4. “Control Techniques Guidelines for Shipbuilding and Ship Repair Operations” (61 FR 44050), August 27, 1996.

    5. “Alternative Control Techniques Document: Surface Coating Operations at Shipbuilding and Ship Repair Facilities EPA 453/R-94-032, April 1994.

    6. “Control Techniques Guidelines for Miscellaneous Metal and Plastic Parts Coatings” EPA-453/R-08-003, September 2008.

    B. Does the rule meet the evaluation criteria?

    Rule 1106 adds several new marine and pleasure craft specialty coating categories, lowers the VOC content limit of other specialty coating categories, and lowers the VOC content limit for solvents used for surface preparation. Under the District's October 23, 2006 SIP-approved rule, some of these new specialty coating categories such as Topcoats, Pleasure Craft, One Component, and Two Component, would have been covered under the “General Use” category and been subject to a more stringent VOC limit when compared to the October 24, 2016 amended rule. The EPA reviewed the potential gross emissions increase associated with the new specialty coating limits and estimates that total VOC emissions associated with these coatings may increase by approximately 250 pounds per year or approximately 0.001% of MDAQMD's VOC inventory. We conclude that this is a negligible increase and would not impact attainment. Because the potential gross increase is minimal, we have not calculated the net impact of the rule revisions, including the emission reductions from strengthened limits. Our evaluation shows this rule is consistent with CAA requirements and relevant guidance regarding enforceability, RACT, and SIP revisions. The TSD has more information on our evaluation.

    C. EPA Recommendations To Further Improve the Rule

    The TSD describes additional rule revisions that we recommend for the next time the local agency modifies the rule.

    D. Public Comment and Proposed Action

    As authorized in section 110(k)(3) of the Act, the EPA proposes to fully approve the submitted rule because we believe it fulfills all relevant requirements. We will accept comments from the public on this proposal until December 18, 2017. If we take final action to approve the submitted rule our final action will incorporate this rule into the federally enforceable SIP.

    III. Incorporation by Reference

    In this rule, the EPA is proposing to include in a final EPA rule regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is proposing to incorporate by reference the MDAQMD rule described in Table 1 of this preamble. The EPA has made, and will continue to make, these materials available through www.regulations.gov and at the EPA Region IX Office (please contact the person identified in the FOR FURTHER INFORMATION CONTACT section of this preamble for more information).

    IV. Statutory and Executive Order Reviews

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

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

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

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

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

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

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

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

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

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

    In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). List of Subjects in 40 CFR Part 52

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

    Authority:

    42 U.S.C. 7401 et seq.

    Dated: November 6, 2017. Alexis Strauss, Acting Regional Administrator, Region IX.
    [FR Doc. 2017-25015 Filed 11-16-17; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R09-OAR-2017-0564; FRL-9970-87-Region 9] Approval of California Air Plan Revisions, Mojave Desert Air Quality Management District AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Proposed rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is proposing to approve and conditionally approve revisions to the Mojave Desert Air Quality Management District (MDAQMD or “District”) portion of the California State Implementation Plan (SIP). These revisions concern the District's demonstration regarding Reasonably Available Control Technology (RACT) requirements for the 1997 8-hour ozone and the 2008 8-hour ozone National Ambient Air Quality Standards (NAAQS or “standard”) in the portion of the Western Mojave Desert ozone nonattainment area under the jurisdiction of the MDAQMD. The EPA is also proposing to approve MDAQMD negative declarations into the SIP for the 2008 ozone standards. We are proposing action on local SIP revisions under the Clean Air Act (CAA or Act). We are taking comments on this proposal and plan to follow with a final action.

    DATES:

    Any comments must arrive by December 18, 2017.

    ADDRESSES:

    Submit your comments, identified by Docket ID No. EPA-R09-OAR-2017-0564 at https://www.regulations.gov/, or via email to Nancy Levin, Rulemaking Office at [email protected] For comments submitted at Regulations.gov, follow the online instructions for submitting comments. Once submitted, comments cannot be removed or edited from Regulations.gov. For either manner of submission, 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, please contact the person identified in the FOR FURTHER INFORMATION CONTACT section. For the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.

    FOR FURTHER INFORMATION CONTACT:

    Nancy Levin, EPA Region IX, (415) 942-3848, [email protected]

    SUPPLEMENTARY INFORMATION:

    Throughout this document, “we,” “us” and “our” refer to the EPA.

    Table of Contents I. The State's Submittal A. What documents did the State submit? B. Are there other versions of these documents? C. What is the purpose of the submitted documents? II. The EPA's Evaluation and Proposed Action A. How is the EPA evaluating the submitted documents? B. Do the documents meet the evaluation criteria? C. EPA Recommendations To Further Improve the RACT SIPs D. Public Comment and Proposed Action III. Statutory and Executive Order Reviews I. The State's Submittal A. What documents did the State submit?

    Table 1 lists the documents addressed by this proposal with the dates that they were adopted by the local air agency and submitted to the EPA by the California Air Resources Board (CARB).

    Table 1—Submitted Documents Local agency Document Adopted Submitted MDAQMD MDAQMD 8-Hour Reasonably Available Control Technology—State Implementation Plan Analysis (RACT SIP Analysis) “2006 RACT SIP” 9/25/06 7/11/2007 MDAQMD MDAQMD 2015 8-Hour Reasonably Available Control Technology —State Implementation Plan Analysis (2015 RACT SIP Analysis) “2015 RACT SIP” 2/23/15 9/9/2015 MDAQMD MDAQMD Federal Negative Declarations for Nineteen Control Techniques Guidelines Source Categories “Negative Declarations for 19 CTGs” 2/23/15 9/9/2015

    In addition to these SIP submittals, the District and CARB transmitted commitment letters to the EPA to adopt and submit specific enforceable measures within a year of our anticipated approval date that would remedy the deficiencies identified in the 2017 MDAQMD and CARB letters to the EPA.1

    1 Letters from Brad Poiriez, Mojave Desert Air Quality Management District (MDAQMD) to Alexis Strauss, U.S. Environmental Protection Agency (EPA) and Richard Corey, California Air Resources Board (CARB), dated September 25, 2017 and September 27, 2017. Letter from Jon Taylor, CARB, to Alexis Strauss, EPA, dated October 3, 2017.

    On January 11, 2008, the submittal for MDAQMD's RACT SIP for the 1997 8-hour ozone NAAQS (2006 RACT SIP) was deemed by operation of law to meet the completeness criteria in Title 40 of the Code of Federal Regulations (CFR) part 51 Appendix V, which must be met before formal EPA review. On March 9, 2016, the submittal for the MDAQMD's 2015 RACT SIP, including negative declarations for 19 CTGs, was found to meet the completeness criteria.

    B. Are there other versions of these documents?

    There are no previous versions of these documents in the MDAQMD portion of the California SIP for the 1997 or 2008 8-hour ozone standards.

    C. What is the purpose of the submitted documents?

    Volatile Organic Compounds (VOCs) and nitrogen oxides (NOX) help produce ground-level ozone and smog, which harm human health and the environment. Section 110(a) of the CAA requires states to submit regulations that control VOCs and NOX emissions. Sections 182(b)(2) and (f) require that SIPs for ozone nonattainment areas classified as Moderate or above implement RACT for any source covered by a Control Techniques Guidelines (CTG) document and for any major source of VOCs or NOX. The MDAQMD is subject to this requirement as it regulates the San Bernardino portion of the Western Mojave Desert ozone nonattainment area that was previously designated and classified as a Moderate nonattainment area for the 1997 NAAQS and is currently classified as a Severe-15 ozone nonattainment area for the 1997 and the 2008 8-hour ozone NAAQS.2 Therefore, the MDAQMD must, at a minimum, adopt RACT-level controls for all sources covered by a CTG document and for all major non-CTG sources of VOCs or NOX within the nonattainment area. Any stationary source that emits or has the potential to emit at least 100 tons per year of VOCs or NOX is a major stationary source in a Moderate ozone nonattainment area (CAA section 182(b)(2), (f) and 302(j)), and any stationary source that emits or has the potential to emit at least 25 tons per year of VOCs or NOX is a major stationary source in a Severe ozone nonattainment area (CAA sections 182(d) and (f)).

    2 40 CFR 81.305; 69 FR 23858 at 23884 (April 30, 2004) (final rule designating and classifying Western Mojave Desert as a Subpart 2/Moderate nonattainment for the 1997 8-hour ozone NAAQS); 77 FR 26950 (May 8, 2012) (final rule reclassifying Western Mojave Desert as Severe-15 nonattainment for the 1997 8-hour ozone NAAQS); and 77 FR 30088 at 30100 (May 21, 2012) (final rule designating and classifying Western Mojave Desert as Severe-15 nonattainment for the 2008 8-hour ozone NAAQS). Western Mojave Desert is listed in the final rulemaking under “Los Angeles-San Bernardino Cos (W Mojave Desert), CA: Los Angeles County (part).” The EPA evaluated MDAQMD's 2006 RACT SIP submittal as a Moderate ozone nonattainment area since the District adopted its 2006 certification based on that classification. On March 13, 2014, the MDAQMD provided additional information to supplement its 2006 RACT SIP, to address the EPA's September 11, 2006 comments on the 2006 RACT SIP.

    Section IV.G of the preamble to the EPA's final rule to implement the 1997 8-hour ozone NAAQS (70 FR 71612, November 29, 2005) discusses RACT requirements. It states in part that where a RACT SIP is required, states implementing the 8-hour standard generally must assure that RACT is implemented, either through a certification that previously required RACT controls still represent RACT for 8-hour implementation purposes or through a new RACT determination. Section III.D of the preamble to the EPA's final rule to implement the 2008 ozone NAAQS (80 FR 12264, March 6, 2015) discusses similar requirements for RACT. The submitted documents provide MDAQMD's analyses of its compliance with the CAA section 182 RACT requirements for the 1997 and 2008 8-hour ozone NAAQS. The EPA's technical support documents (TSDs) 3 have more information about the District's submissions and the EPA's evaluations thereof.

    3 The docket for this proposed action contains two TSDs, one addressing the 2006 RACT SIP, and one addressing the 2015 RACT SIP and Negative Declarations for 19 CTGs.

    II. The EPA's Evaluation and Proposed Action A. How is the EPA evaluating the submitted documents?

    SIP rules must require RACT for each category of sources covered by a CTG document as well as each major source of VOCs or NOX in ozone nonattainment areas classified as Moderate or above (see CAA section 182(b)(2)). The MDAQMD regulates a Severe ozone nonattainment area (see 40 CFR 81.305), so the District's rules must implement RACT.

    States should also submit for SIP approval negative declarations for those source categories for which they are not adopting CTG-based regulations (because they have no sources above the CTG recommended threshold) regardless of whether such negative declarations were made for an earlier SIP.4 To do so, the submittal should provide reasonable assurance that no sources subject to the CTG requirements currently exist or are planned for the MDAQMD.

    4 57 FR 13498, 13512 (April 16, 1992). The EPA previously approved several negative declarations submitted by MDAQMD. See 76 FR 29153 (May 20, 2011).

    The District's analysis must demonstrate that each major source of NOX or VOCs in the nonattainment area is covered by a RACT-level rule. In addition, for each CTG source category, the District must either demonstrate that a RACT-level rule is in place, or submit a negative declaration. Guidance and policy documents that we use to evaluate CAA section 182 RACT requirements include the following:

    1. “Final Rule to Implement the 8-hour Ozone National Ambient Air Quality Standard—Phase 2”: (70 FR 71612; November 29, 2005).

    2. “State Implementation Plans; General Preamble for the Implementation of Title I of the Clean Air Act Amendments of 1990,” 57 FR 13498 (April 16, 1992); 57 FR 18070 (April 28, 1992).

    3. “Issues Relating to VOC Regulation Cutpoints, Deficiencies, and Deviations,” EPA, May 25, 1988 (the Bluebook, revised January 11, 1990).

    4. “Guidance Document for Correcting Common VOC & Other Rule Deficiencies,” EPA Region 9, August 21, 2001 (the Little Bluebook).

    5. “State Implementation Plans; Nitrogen Oxides Supplement to the General Preamble; Clean Air Act Amendments of 1990 Implementation of Title I; Proposed Rule,” (the NOX Supplement), 57 FR 55620, November 25, 1992.

    6. Memorandum from William T. Harnett to Regional Air Division Directors, (May 18, 2006), “RACT Qs & As—Reasonably Available Control Technology (RACT) Questions and Answers.”

    7. RACT SIPs, Letter dated March 9, 2006 from EPA Region IX (Andrew Steckel) to CARB (Kurt Karperos) describing Region IX's understanding of what constitutes a minimally acceptable RACT SIP.

    8. RACT SIPs, Letter dated April 4, 2006 from EPA Region IX (Andrew Steckel) to CARB (Kurt Karperos) listing EPA's current CTGs, ACTs, and other documents which may help to establish RACT.

    9. “Implementation of the 2008 National Ambient Air Quality Standards for Ozone: State Implementation Plan Requirements” (80 FR 12264; March 6, 2015).

    With respect to major stationary sources, because the Western Mojave Desert ozone nonattainment area was classified as “Moderate” nonattainment for the 1997 8-hour ozone NAAQS at the time that California submitted the 2006 RACT SIP to the EPA, the EPA evaluated this submission in accordance with the 100 ton per year (tpy) threshold for “major stationary sources” of VOCs or NOX emissions in Moderate ozone nonattainment areas. (see CAA sections 182(b)(2) and (f)).

    MDAQMD's 2015 RACT SIP submittal contains the District's RACT evaluation for major stationary sources in accordance with the 25 tpy threshold for major stationary sources of VOCs or NOX emissions in Severe ozone nonattainment areas. (see CAA sections 182(d) and (f)). The EPA also evaluated MDAQMD's submittals for compliance with the additional RACT requirements that became applicable following the EPA's reclassification of the Western Mojave Desert ozone nonattainment area from “Moderate” to “Severe” nonattainment for the 1997 8-hour ozone NAAQS and classification as a Severe ozone nonattainment area for the 2008 8-hour ozone NAAQS.

    B. Do the documents meet the evaluation criteria?

    We find that the District's submissions are largely consistent with the applicable CAA requirements. The District has identified rule deficiencies for certain rules, and in light of the District's commitment to adopt specific enforceable measures to remedy the identified rule deficiencies, the EPA will propose to conditionally approve portions of the submittals.

    The SIP submittals and supplementary material demonstrate that all of the identified SIP rules implement RACT for the applicable CTG categories and for the major non-CTG stationary sources of VOCs and NOX for the 1997 and 2008 8-hour ozone NAAQS, with the exception of the following rules: Rule 461, Gasoline Transfer and Dispensing; Rule 462, Organic Liquid Loading; Rule 463, Storage of Organic Liquids; Rule 1104, Organic Solvent Degreasing; Rule 1106, Marine Coating Operations; Rule 1114, Wood Products Coating Operations; Rule 1115, Metal Parts & Product Coating Operations; Rule 1157, Boilers and Process Heaters; Rule 1160, Internal Combustion Engines; Rule 1161, and Portland Cements Kilns; Rule 1162, Polyester Resin Operations.

    On February 24, 2017, CARB submitted an updated version of Rule 1106, Marine Coating Operations. The EPA has concluded that the District's revisions of this rule cure the deficiencies identified by the District in its 2015 RACT SIP Analysis. We are proposing approval of this rule in parallel with the present proposed action.

    On September 25, 2017 and September 27, 2017, the District transmitted to CARB and the EPA commitments to adopt new or revised rules that will resolve the identified rule deficiencies in the remaining rules, and to transmit these rules to CARB no later than December 31, 2018. On October 3, 2017, CARB committed to submit these rules to the EPA no later than January 31, 2019.5 These letters commit the District to adopt specific enforceable measures to correct the rule deficiencies, commit the state to submit them to the EPA by a date certain, and are clear and enforceable. Accordingly, we believe these commitment letters are consistent with CAA requirements regarding conditional approval for the 2006 and 2015 RACT SIPs with respect to the rules cited above.6 See CAA section 110(k)(4).

    5 Letters from Brad Poiriez, Mojave Desert Air Quality Management District (MDAQMD) to Alexis Strauss, U.S. Environmental Protection Agency (EPA) and Richard Corey, California Air Resources Board (CARB), dated September 25 and September 27, 2017. Letter from Jon Taylor, CARB, to Alexis Strauss, EPA, dated October 3, 2017.

    6 We note that the District has begun acting on its commitment. MDAQMD has drafted revisions to Rules 461, 462, 463 and 1115 and is in the process of responding to EPA's comments on the preliminary draft amendments.

    Where there are no existing sources covered by a particular CTG document, states may, in lieu of adopting RACT requirements for those sources, adopt negative declarations certifying that there are no such sources in the relevant nonattainment area. On September 9, 2015, CARB submitted for SIP inclusion MDAQMD's negative declarations for 19 CTG source categories. The District certified that it examined its permit files, emissions inventory and other documentation and determined that there are no sources in the CTG source categories listed in Table 2.7 The District adopted the negative declarations on February 23, 2015, after reasonable notice and public comment.8 We searched CARB's emissions inventory database and verified that there did not appear to be facilities in the MDAQMD that might be subject to the 19 CTG categories. We conclude that these negative declarations are consistent with the relevant policy and guidance regarding RACT. The TSDs for today's action have more information on our evaluation.

    7 Mojave Desert Air Quality Management District Federal Negative Declaration (8 hr Ozone Standard) for Nineteen CTG Categories, signed by Eldon Heaston, Executive Officer, signed on January 13, 2015, and Board adopted on February 23, 2015.

    8 See Resolution 15-03; February 23, 2015.

    9 The District also lists “Protocol for Determining the Daily VOC Emission Rate of Automobile and Light-Duty Truck Primer-Surfacer and Topcoat Operations (EPA 453/R-08-002, 09/08),” however, this document is not a CTG.

    10 The District also lists “Control Techniques for VOC Emissions from Stationary Sources: Industrial Manufacturing Processes (EPA-453/R-92-018, 12/92, NTIS PB-93-150-258),” however, this is not a CTG document.

    Table 2—Negative Declarations CTG source category CTG reference document Large Petroleum Dry Cleaners EPA 450/3-82-009, 9/82 Control of VOC Emissions from Large Petroleum Dry Cleaners. Manufacture of High-Density Polyethylene, Polypropylene, and Polystyrene Resins EPA-450/3-83-008, 11/83 Control of Volatile Organic Compound Emissions from Manufacture of High-Density Polyethylene, Polypropylene, and Polystyrene Resins. Manufacture of Pneumatic Rubber Tires EPA-450/2-78-030, Control of Volatile Organic Emissions from Manufacture of Pneumatic Rubber Tires. Surface Coating of Cans EPA-450/2-77-008, 5/77 Control of Volatile Organic Emissions from Existing Stationary Sources—Vol. II: Surface Coating of Cans, Coils, Paper, Fabrics, Automobiles, and Light-Duty Trucks. Surface Coating of Coils EPA-450/2-77-008, 5/77 Control of Volatile Organic Emissions from Existing Stationary Sources—Vol. II: Surface Coating of Cans, Coils, Paper, Fabrics, Automobiles, and Light-Duty Trucks. Surface Coating Operations at Automotive and Light Duty Truck Assembly Plants EPA 453/R-08-006, 09/08, Control Technique Guidelines for Automobile and Light-Duty Truck Assembly Coatings.9
  • EPA-450/2-77-008, 5/77 Control of Volatile Organic Emissions from Existing Stationary Sources—Vol. II: Surface Coating of Cans, Coils, Paper, Fabrics, Automobiles, and Light-Duty Trucks.
  • Large Appliances, Surface Coatings EPA-450/2-77-034, 12/77 Control of Volatile Organic Emissions from Existing Stationary Sources—Volume V: Surface Coating of Large Appliances.
  • EPA 453/R-07-004, 09/07, Control Techniques Guidelines for Large Appliance Coatings.
  • Surface Coating of Magnet Wire EPA-450/2-77-033, 12/77 Control of Volatile Organic Emissions from Existing Stationary Sources, Volume IV: Surface Coating of Insulation of Magnet Wire. Vacuum Producing Devices or Systems EPA-450/2-77-025, 10/77 Control of Refinery Vacuum Producing Systems, Wastewater Separators, and Process Unit Turnarounds. Leaks from Petroleum Refinery Equipment EPA-450/2-77-025, 10/77 Control of Refinery Vacuum Producing Systems, Wastewater Separators, and Process Unit Turnarounds. Process Unit Turnarounds EPA-450/2-77-025, 10/77 Control of Refinery Vacuum Producing Systems, Wastewater Separators, and Process Unit Turnarounds. Equipment Leaks from Natural Gas/Gasoline Processing Plants EPA-450/3-83-007,12/83 Control of Volatile Organic Compound Equipment Leaks from Natural Gas/Gasoline Processing Plants. Manufacture of Synthesized Pharmaceutical Products EPA-450/2-78-029, 12/78 Control of Volatile Organic Emissions from Manufacture of Synthesized Pharmaceutical Products.10 Air Oxidation Processes (SOCMI) EPA-450/3-84-015, 12/84 Control of Volatile Organic Compound Emissions from Air Oxidation Process in Synthetic Organic Chemical Manufacturing Industry (SOCMI). Reactor and Distillation Processes (SOCMI) EPA-450/4-91-031, 08/93 Control of Volatile Organic Compound Emissions from Reactor Process and Distillation Operations in SOCMI. Equipment used in Synthetic Organic Chemical Polymers and Resin Manufacturing EPA-450/3-83-006, 03/84 Control of Volatile Organic Compound Leaks from Synthetic Organic Chemical Polymer and Resin Manufacturing Equipment. Leaks from Petroleum Refinery Equipment EPA-450/2-78-036, 06/78 Control of Volatile Organic Compound Leaks from Petroleum Refinery Equipment. Metal Furniture Coating EPA-450/2-77-032, 12/77 Control of Volatile Organic Emissions from Existing Stationary Sources—Volume III: Surface Coating of Metal Furniture.
  • EPA 453/R-07-005, 09/07 Control Techniques Guidelines for Metal Furniture Coatings.
  • Flat Wood Paneling EPA-450/2-78-032, 06/78 Control of Volatile Organic Emissions from Existing Stationary Sources—Volume VII: Factory Surface Coating of Flat Wood Paneling.
  • EPA-453/R-06-004, 09/06 Control Techniques Guidelines for Flat Wood Paneling Coatings.
  • Accordingly, the District's 2006 and 2015 RACT SIP submittals satisfy the CAA section 182 RACT requirements, with the exception of the rules identified above, which the District has either already corrected, or has committed to correct.

    Our 2006 and 2015 RACT SIP TSDs have more information on our evaluation.

    C. EPA Recommendations To Further Improve the RACT SIPs

    The 2015 RACT SIP TSD describes recommendations if additional emission reductions are needed for the next time the local agency modifies its rules.

    D. Public Comment and Proposed Action

    If a portion of a plan revision meets all the applicable CAA requirements, section 110(k)(3) authorizes the EPA to approve the plan revision in part. 42 U.S.C. 7410(k)(3). In addition, section 110(k)(4) authorizes the EPA to conditionally approve a plan revision based on a commitment by the state to adopt specific enforceable measures by a date certain but not later than one year after the date of the plan approval. 42 U.S.C. 7410(k)(4). In this instance, the enforceable measures that the state must submit are new or revised rules that correct the rule deficiencies identified above. On October 3, 2017, the state transmitted a commitment letter dated September 25, 2017 from the MDAQMD to adopt and transmit rules or rule revisions to the state that correct the deficiencies identified in Rule 461, Gasoline Transfer and Dispensing; Rule 462, Organic Liquid Loading; Rule 463, Storage of Organic Liquids; Rule 1104, Organic Solvent Degreasing; Rule 1114, Wood Products Coating Operations; Rule 1115, Metal Parts and Product Coating Operations; Rule 1157, Boilers and Process Heaters; Rule 1160, Internal Combustion Engines; Rule 1161, Portland Cement Kilns; and Rule 1162, Polyester Resin Operations no later than December 31, 2018. The state also transmitted a second commitment letter from MDAQMD dated September 27, 2017 to adopt and transmit revised Rule 1104, Organic Solvent Degreasing and Rule 1162, Polyester Resin Operations no later than December 31, 2018. The state's transmittal letter commits the state to submit to the EPA these rules no later than January 31, 2019.

    If the MDAQMD or the state fail to comply with this commitment, this proposed conditional approval would convert to a disapproval and start an 18-month clock for sanctions under CAA section 179(a)(2) and a two-year clock for a federal implementation plan under CAA section 110(c)(1).

    As authorized in section 110(k)(3) and (4) of the Act, the EPA proposes to partially conditionally approve MDAQMD's 2006 and 2015 RACT SIPs with respect to Rule 461, Gasoline Transfer and Dispensing; Rule 462, Organic Liquid Loading; Rule 463, Storage of Organic Liquids; Rule 1104, Organic Solvent Degreasing; Rule 1114, Wood Products Coating Operations; Rule 1115, Metal Parts and Product Coating Operations; Rule 1157, Boilers and Process Heaters; Rule 1160, Internal Combustion Engines; Rule 1161, Portland Cement Kilns; and Rule 1162, Polyester Resin Operations. Simultaneously, EPA proposes to partially approve the remainder of MDAQMD's 2006 and 2015 RACT SIPs, and to fully approve MDAQMD's negative declarations, submitted on September 9, 2015.

    We will accept comments from the public on this proposal until December 18, 2017. If we take final action to approve the submitted documents, our final action will incorporate these documents into the SIP.

    III. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive Orders can be found at http://www2.epa.gov/laws-regulations/laws-and-executive-orders.

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

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

    B. Executive Order 13771: Reducing Regulations and Controlling Regulatory Costs

    This action is not an Executive Order 13771 regulatory action because actions such as SIP approvals are exempted under Executive Order 12866.

    C. Paperwork Reduction Act (PRA)

    This action does not impose an information collection burden under the PRA because this action does not impose additional requirements beyond those imposed by state law.

    D. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. This action will not impose any requirements on small entities beyond those imposed by state law.

    E. Unfunded Mandates Reform Act (UMRA)

    This action does not contain any unfunded mandate as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. This action does not impose additional requirements beyond those imposed by state law. Accordingly, no additional costs to state, local, or tribal governments, or to the private sector, will result from this action.

    F. Executive Order 13132: Federalism

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

    G. Executive Order 13175: Coordination With Indian Tribal Governments

    This action does not have tribal implications, as specified in Executive Order 13175, because the SIP is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction, and will not impose substantial direct costs on tribal governments or preempt tribal law. Thus, Executive Order 13175 does not apply to this action.

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

    The EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental health or safety risks that the EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order. This action is not subject to Executive Order 13045 because it does not impose additional requirements beyond those imposed by state law.

    I. Executive Order 13211: Actions That Significantly Affect Energy Supply, Distribution, or Use

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

    J. National Technology Transfer and Advancement Act (NTTAA)

    Section 12(d) of the NTTAA directs the EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. The EPA believes that this action is not subject to the requirements of section 12(d) of the NTTAA because application of those requirements would be inconsistent with the CAA.

    K. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Population

    The EPA lacks the discretionary authority to address environmental justice in this rulemaking.

    List of Subjects in 40 CFR Part 52

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

    Authority:

    42 U.S.C. 7401 et seq.

    Dated: November 6, 2017. Alexis Strauss, Acting Regional Administrator, Region IX.
    [FR Doc. 2017-25017 Filed 11-16-17; 8:45 am] BILLING CODE 6560-50-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES 42 CFR Part 71 RIN 0920-AA14 Foreign Quarantine Regulations, Proposed Revision of HHS/CDC Animal Importation Regulations AGENCY:

    Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).

    ACTION:

    Advance notice of proposed rulemaking; withdrawal.

    SUMMARY:

    The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) announces the withdrawal of its 2007 advance notice of proposed rulemaking (ANPRM). The 2007 ANPRM was issued to begin the process of revising the regulations concerning importation of animals and animal products.

    DATES:

    As of November 17, 2017, the ANPRM published on July 31, 2007, at 72 FR 41676, is withdrawn.

    FOR FURTHER INFORMATION CONTACT:

    Anne E. O'Connor, M.S., MT(ASCP), Office of the Chief of Staff, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-A14, Atlanta, GA 30329; email: [email protected]

    SUPPLEMENTARY INFORMATION:

    On July 31, 2007, HHS/CDC published an advance notice of proposed rulemaking (72 FR 41679) requesting input and background information from the public on revisions to HHS/CDC's animal importation regulations found at 42 CFR part 71. The ANPRM had a 60-day comment period. On October 1, 2007, HHS/CDC published another notice (72 FR 55729) that extended the public comment period to December 1, 2007.

    In response to the ANPRM, HHS/CDC received 20 public comments including from individuals, organizations, three animal-rescue advocacy groups, one private pet business, and one state government entity. Some commenters asserted that the current regulations fail to take into account the increasing volume of animal imports and new threats to human health and safety posed by these imports. Other commenters asserted that the same rules and fees applicable to commercial importers should be extended to non-profit animal shelters, rescue groups, and animal sanctuaries that effectively function as pet stores. The topics that received the most comments were changing the rabies regimen and requiring health certificate and unique identifiers for dogs, cats, and ferrets; and other strategies for preventing the introduction, spread, and transmission of zoonotic disease in the United States.

    HHS/CDC believes the public interest is best served by withdrawing the ANPRM identified in this document from rulemaking. The withdrawal of the ANPRM identified in this document does not preclude HHS/CDC from initiating future rulemaking to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the United States and from one State or possession into another.

    The ANPRM published on July 31, 2007 (72 FR 41676), is hereby withdrawn.

    Dated: November 13, 2017. Eric D. Hargan, Acting Secretary, Department of Health and Human Services.
    [FR Doc. 2017-24951 Filed 11-16-17; 8:45 am] BILLING CODE 4163-18-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES 42 CFR Part 73 [Docket No. CDC-2015-0050] RIN 0920-AA58 Possession, Use, and Transfer of Select Agents and Toxins; Addition of Certain Influenza Virus Strains to the List of Select Agents and Toxins AGENCY:

    Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).

    ACTION:

    Notice of proposed rulemaking; withdrawal.

    SUMMARY:

    The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) announces the withdrawal of its 2015 notice of proposed rulemaking (NPRM). The 2015 NPRM proposed to add certain influenza virus strains to the list of HHS select agents and toxins.

    DATES:

    The proposed rule published on July 16, 2015 (80 FR 42079), is withdrawn as of November 17, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Samuel S. Edwin, Director, Division of Select Agents and Toxins, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-A46, Atlanta, GA 30329. Telephone: (404) 718-2000.

    SUPPLEMENTARY INFORMATION:

    On July 16, 2015, HHS/CDC published a proposed rule (80 FR 42079) to add certain influenza virus strains to the list of HHS select agents and toxins. Specifically, HHS/CDC proposed to add the influenza viruses that contain the hemagglutinin (HA) from the Goose Guangdong/1/96 lineage (the influenza viruses that contain the hemagglutinin (HA) from the A/Gs/Gd/1/96 lineage), including wild-type viruses as a non-Tier 1 select agent. HHS/CDC also proposed to add any influenza viruses that contain the HA from the A/Gs/Gd/1/96 lineage that were made transmissible among mammals by respiratory droplets in a laboratory as a Tier 1 select agent.

    In response to the NPRM, HHS/CDC received 24 comments from industry, academic institutions, professional organizations, and the public. Commenters expressed concern about balancing the risk of impeding research against the risk of an accidental laboratory incident or act of terrorism. Other commenters were concerned that regulation might further limit the ability of veterinarians, researchers, and farmers to identify and respond to influenza outbreaks. Finally, some commenters pointed out that highly pathogenic avian influenza viruses are already regulated as a Department of Agriculture/Animal and Plant Health Inspection Service (USDA/APHIS) select agent. HHS/CDC agreed with the commenters. Since the publication of the NPRM, the U.S. Government has put in place additional controls regarding the funding and approval of dual use research. In addition, HHS/CDC has worked with USDA/APHIS to ensure that biosafety and biosecurity protocols/measures are in place for regulated entities working with highly pathogenic avian influenza viruses to mitigate the risk to public health and safety. Thus, HHS/CDC believes the public interest is best served by the withdrawal of the NPRM identified in this document. The withdrawal of the proposed rule identified in this document does not preclude HHS/CDC from initiating future rulemaking concerning the influenza viruses that contain the hemagglutinin (HA) from the Goose Guangdong/1/96 lineage (the influenza viruses that contain the hemagglutinin (HA) from the A/Gs/Gd/1/96 lineage), including wild-type viruses or influenza viruses that contain the HA from the A/Gs/Gd/1/96 lineage that were made transmissible among mammals by respiratory droplets.

    The NPRM published on July 16, 2015 (82 FR 42079), is hereby withdrawn.

    Dated: November 13, 2017. Eric D. Hargan, Acting Secretary, Department of Health and Human Services.
    [FR Doc. 2017-24952 Filed 11-16-17; 8:45 am] BILLING CODE 4163-18-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES 42 CFR Part 84 [Docket No. HHS-OS-2009-0019; NIOSH-0137] RIN 0920-AA33 Total Inward Leakage Requirements for Respirators AGENCY:

    Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).

    ACTION:

    Notice of proposed rulemaking; withdrawal.

    SUMMARY:

    The National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) announces the withdrawal of its 2009 notice of proposed rulemaking (NPRM). The 2009 NPRM proposed to establish total inward leakage requirements for half-mask, air-purifying particulate respirators approved by NIOSH.

    DATES:

    As of November 17, 2017, the proposed rule published on October 30, 2009, at 74 FR 56141, is withdrawn.

    FOR FURTHER INFORMATION CONTACT:

    Rachel Weiss, Office of the Director, National Institute for Occupational Safety and Health, 1090 Tusculum Avenue, MS-C46, Cincinnati, OH 45226. Telephone: (855) 818-1629 (this is a toll-free number); email: [email protected]

    SUPPLEMENTARY INFORMATION:

    On October 30, 2009, HHS published an NPRM (74 FR 56141) that proposed to establish total inward leakage requirements for half-mask, air-purifying particulate respirators approved by NIOSH under regulations found in 42 CFR part 84. The NPRM included a 60-day comment period closing on December 29, 2009, which was eventually extended to September 30, 2010 (April 20, 2010, 75 FR 20546).

    In response to the proposed rule, HHS received comments from five respirator manufacturers, one manufacturer of laboratory test equipment, two labor unions, one trade organization, one state's departments of public health and occupational safety and health, three consulting firms, and three private individuals in the field of respiratory protection. Stakeholders presented evidence that the approval decision outcomes could vary significantly between human subject panels that would be constituted according to the proposed test protocol, and expressed concern that the proposed approval requirements would not improve the performance of NIOSH-approved respirators on the market and might eliminate good-performing respirators from the market. Stakeholders also expressed concern that the cost of conducting inward leakage testing using the protocol proposed by NIOSH would be prohibitive and that costs would likely outweigh benefits.

    As a result of the stakeholder input submitted to the docket and during public meetings, NIOSH decided instead to pursue improved inward leakage performance of this class of respirators through participation in national and international consensus standard development efforts, rather than rulemaking. Thus, HHS finds that the public interest is best served by withdrawing the 2009 total inward leakage NPRM. The withdrawal of the 2009 total inward leakage NPRM does not preclude HHS from initiating future rulemaking concerning total inward leakage requirements for half-mask, air-purifying particulate respirators.

    The NPRM published on October 30, 2009 (74 FR 56141) is hereby withdrawn.

    Dated: November 13, 2017. Eric D. Hargan, Acting Secretary, Department of Health and Human Services.
    [FR Doc. 2017-24950 Filed 11-16-17; 8:45 am] BILLING CODE 4163-18-P
    82 221 Friday, November 17, 2017 Notices DEPARTMENT OF AGRICULTURE Submission for OMB Review; Comment Request November 14, 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 December 18, 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), [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.

    Food and Nutrition Service

    Title: Summer Meal Study.

    OMB Control Number: 0584-NEW.

    Summary of Collection: The USDA Summer Food Service Program (SFSP) and the National School Lunch Program Seamless Summer Option (SSO) provide healthy meals and snacks to children through 18 years of age, in low-income areas during summer months when school is not in session. Legislation requires programs participating in the SFSP or SSO to participate in program research and evaluation (Section 305 of the Healthy Hunger Free Kids Act).

    Need and Use of the Information: In July 2016, the programs served 3.85 million summer meals to participating children. However, summer meals reach only a small percent of the children receiving free or reduced price meals during the school year. This study will help identify strategies to increase participation in summer meals as well as assess the nutritional quality of the meals served to children.

    Description of Respondents: Individuals/Households (112,783); Business-not-for-profit (734) and State, Local & Tribal agencies (1,142).

    Number of Respondents: 114,659.

    Frequency of Responses: Reporting: Annually.

    Total Burden Hours: 215,196.

    Ruth Brown, Departmental Information Collection Clearance Officer.
    [FR Doc. 2017-24940 Filed 11-16-17; 8:45 am] BILLING CODE 3410-30-P
    DEPARTMENT OF AGRICULTURE Forest Service Black Hills National Forest Advisory Board AGENCY:

    Forest Service, USDA.

    ACTION:

    Notice of meeting.

    SUMMARY:

    The Black Hills National Forest Advisory Board (Board) will meet in Rapid City, South Dakota. The Board is established consistent with the Federal Advisory Committee Act of 1972, the Forest and Rangeland Renewable Resources Planning Act of 1974, the National Forest Management Act of 1976, and the Federal Public Lands Recreation Enhancement Act. Additional information concerning the Board, including the meeting summary/minutes, can be found by visiting the Board's Web site at: http://www.fs.usda.gov/main/blackhills/workingtogether/advisorycommittees.

    DATES:

    The meeting will be held on Wednesday, January 10, 2018, at 1:00 p.m.

    All meetings are subject to cancellation. For updated status of meeting prior to attendance, please contact the person listed under For Further Information Contact.

    ADDRESSES:

    The meeting will be held at the Forest Service Center, 8221 Mount Rushmore Road, Rapid City, South Dakota.

    Written comments may be submitted as described under Supplementary Information. All comments, including names and addresses, when provided, are placed in the record and available for public inspection and copying. The public may inspect comments received at the Black Hills National Forest Supervisor's Office. Please call ahead to facilitate entry into the building.

    FOR FURTHER INFORMATION CONTACT:

    Scott Jacobson, Committee Coordinator, by phone at 605-440-1409 or by email at [email protected]

    Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 between 8:00 a.m. and 8:00 p.m., Eastern Standard Time, Monday through Friday.

    SUPPLEMENTARY INFORMATION:

    The purpose of the meeting is to provide:

    (1) Information Topic: FY 2018 Forest Budget Overview;

    (2) Pile burning update;

    (3) Over snow use;

    (4) Recreation Site Analysis (RSA) update;

    (5) Black Hills Resilient Landscape Project update; and

    (6) Mountain pine beetle brood survey report.

    The meeting is open to the public. If time allows, the public may make oral statements of three minutes or less. Individuals wishing to make an oral statement should submit a request in writing by December 26, 2017, to be scheduled on the agenda. Anyone who would like to bring related matters to the attention of the Board may file written statements with the Board's staff before or after the meeting. Written comments and time requests for oral comments must be sent to Scott Jacobson, Black Hills National Forest Supervisor's Office, 1019 North Fifth Street, Custer, South Dakota 57730; by email to [email protected], or via facsimile to 605-673-9208.

    Meeting Accommodations: If you are a person requiring reasonable accommodation, please make requests in advance for sign language interpreting, assistive listening devices, or other reasonable accommodation for access to the facility or proceedings by contacting the person listed in the section titled For Further Information Contact. All reasonable accommodation requests are managed on a case by case basis.

    Dated: October 24, 2017. Chris French, Associate Deputy Chief, National Forest System.
    [FR Doc. 2017-24914 Filed 11-16-17; 8:45 am] BILLING CODE 3411-15-P
    DEPARTMENT OF COMMERCE Census Bureau Proposed Information Collection; Comment Request; American Community Survey Methods Panel Tests AGENCY:

    U.S. Census Bureau, Commerce.

    ACTION:

    Notice.

    SUMMARY:

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

    DATES:

    To ensure consideration, written comments must be submitted on or before January 16, 2018.

    ADDRESSES:

    Please direct all written comments to Jennifer Jessup, Departmental Paperwork Clearance Officer, Department of Commerce, Room 6616, 14th and Constitution Avenue NW., Washington, DC 20230 (or via the Internet at [email protected]). You may also submit comments, identified by Docket number USBC-2017-0006, to the Federal e-Rulemaking Portal: http://www.regulations.gov. All comments received are part of the public record. No comments will be posted to http://www.regulations.gov for public viewing until after the comment period has closed. Comments will generally be posted without change. All Personally Identifiable Information (for example, name and address) voluntarily submitted by the commenter may be publicly accessible. Do not submit Confidential Business Information or otherwise sensitive or protected information. You may submit attachments to electronic comments in Microsoft Word, Excel, WordPerfect, or Adobe PDF file formats only.

    FOR FURTHER INFORMATION CONTACT:

    Requests for additional information or copies of the information collection instrument(s) and instructions should be directed to Robin A. Pennington, U.S. Census Bureau, Decennial Census Management Division, 4600 Silver Hill Rd., Washington, DC 20233, or email at [email protected]

    SUPPLEMENTARY INFORMATION: I. Abstract

    The American Community Survey (ACS) collects detailed socioeconomic data from about 3.5 million addresses in the United States and 36,000 in Puerto Rico each year. The ACS also collects detailed socioeconomic data from about 195,000 residents living in Group Quarters (GQ) facilities. Resulting tabulations from this data collection are provided on a yearly basis. The ACS allows the Census Bureau to provide timely and relevant housing and socioeconomic statistics, even for small geographies.

    An ongoing data collection effort with an annual sample of this magnitude requires that the ACS continue research, testing, and evaluations aimed at improving data quality, achieving survey cost efficiencies, and improving ACS questionnaire content and related data collection materials. The ACS Methods Panel is a research program designed to address and respond to survey issues and needs. From 2018 to 2021, the ACS Methods Panel may include testing methods for increasing survey efficiencies, reducing survey cost, lessening respondent burden, improving response rates, and improving data quality.

    At this time, plans are in place to propose several tests: Self-response mail messaging tests, a respondent burden field test, testing the use of administrative data, GQ testing, and two content tests. Since the ACS Methods Panel is designed to address emerging issues, we may conduct additional testing as needed. Any additional testing would focus on methods for reducing data collection costs, improving data quality, improving the respondent experience, revising content, or testing new questions that have an urgent need to be included on the ACS.

    In response to declining response rates and increasing costs, the Census Bureau plans to study methods to increase self-response, the least expensive mode of data collection. The Census Bureau currently sends up to five mailings to a sampled address to inform the occupants that their address has been selected and to encourage them to respond to the ACS. The proposed tests would include changes to messages included in the mailings to motivate the public to respond to the ACS. The proposed tests would also include modifications to the materials, including the mailing type (for example, sending letters versus postcards). Changes to the number of mailings or the timing of the mailings may be explored. The Census Bureau is also considering testing automated phone reminders.

    In 2014, the ACS conducted a comprehensive content review to ensure that only the information needed is requested and that the justifications provided by federal agencies for the ACS questions are current and valid (Chappell and Obenski, 2014). The Census Bureau takes very seriously respondent burden and concerns and recognizes that the content review process was only an initial step to addressing them. The Census Bureau has worked hard to identify a range of possibilities for reducing perceived respondent burden while still maintaining the irreplaceable quality and richness of ACS data (Hughes et al., 2015, Griffin and Hughes, 2013, Hughes et al., 2016, Heimel et al., 2016, Oliver et al., 2016). In a workshop held in 2016, the National Academies of Science Committee on National Statistics recommended identifying a way to quantify or measure respondent burden (National Academies of Sciences, Engineering, and Medicine, 2016). The Census Bureau has begun work to understand respondents' experience responding to the ACS through focus groups and cognitive testing. The next step for this work is to conduct a field test, implementing questions to measure respondent burden.

    The Census Bureau has made significant progress exploring the use of administrative data in surveys and censuses, potentially as a substitute for questions asked of respondents. Administrative data refer to data collected by government agencies for the purposes of administering programs or providing services. The Census Bureau has evaluated the availability and suitability of several different data sources for use in the ACS on telephone service, the year a residence was built, condominium status, income, residence one year ago, and self-employment income. We are currently exploring administrative data use for property values, property taxes, and acreage. Additionally, we plan to evaluate the quality, coverage, and feasibility of using administrative records in lieu of enumeration for institutional GQs (U.S. Census Bureau, 2017). In addition to replacing questions on the survey, administrative data may be used to reduce burden of existing questions by allowing for modification of the questions. For example, the ACS currently asks respondents to provide their total income for the past 12 months as well as income received from various sources (for example, wages, interest, retirement income). We are currently cognitively testing modifications to the income questions, including changing the reference year from the past 12 months to the previous calendar year, as well as only asking respondents if income was received from various sources rather than the amount. As a continuation of this research, the Census Bureau proposes a field test of revised content, for income as well as other topics both for the housing unit questionnaire as well as the GQ questionnaire. Some questions may be modified while others would be removed.

    The ACS samples about 18,000 GQ facilities each year. A GQ is a place where people live or stay, in a group living arrangement, which is owned or managed by an entity or organization providing housing and/or services for the residents. There are two categories of GQs: Institutional and non-institutional. Institutional GQs include places such as correctional facilities and nursing homes. Non-institutional GQs include college housing, military barracks, and residential treatment centers. Most interviews conducted in GQs are interviewer-administered (over 90 percent of interviews in institutional GQs and just under 75 percent in non-institutional GQs), but some GQ respondents self-respond using a paper questionnaire. The Census Scientific Advisory Committee Working Group on Group Quarters in the ACS recommended that the Census Bureau consider making an “internet version of the ACS available to non-institutional GQ residents, especially in college dorms, military barracks, and group homes” (National Academies of Sciences, Engineering, and Medicine, 2016). Additional support was identified for this in a workshop held in 2016 with the National Academies of Science Committee on National Statistics. The Census Bureau proposes a field test of an internet self-response GQ form for residents in non-institutional GQs.

    Working through the Office of Management and Budget (OMB) Interagency Committee for the ACS, the Census Bureau will solicit proposals from other Federal agencies to change existing questions or add new questions to the ACS. The Census Bureau proposes testing any new or revised questions in one of two content tests. A content test using all modes of data collection will be conducted in 2021. Conducting a self-response only content test prior to 2021 allows the Census Bureau to be more agile in reacting to changes in society and legislation. The objective of both content tests is to determine the impact of changing question wording and response categories, as well as redefining underlying constructs, on the quality of the data collected. The Census Bureau proposes to evaluate changes to current questions by comparing the revised questions to the current ACS questions. For new questions, the Census Bureau proposes to compare the performance of two versions of any new questions and benchmark results to other well-known sources of such information.

    References Chappell, Gary and Sally Obenski. 2014. American Community Survey Fiscal Year 2014 Content Review. U.S. Census Bureau. Accessed 8/1/2017 at, https://www.census.gov/programs-surveys/acs/operations-and-administration/2014-content-review.html. Griffin, Deborah and Todd Hughes. 2013. Effect of Changing Call Parameters in the American Community Survey's Computer Assisted Telephone Interviewing Operation. ACS13-RER-17. U.S. Census Bureau. Accessed 8/1/2017 at, http://www.census.gov/library/working-papers/2013/acs/2013_Griffin_03.html. Heimel, Sarah, Dorothy Barth, and Megan Rabe. 2016. “Why We Ask” Mail Package Insert Test. ACS16-MP-07. U.S. Census Bureau. Accessed 8/1/2017 at, https://www.census.gov/library/working-papers/2016/acs/2016_Heimel_01.html. Hughes, Todd, Michael Beaghen, and Mark Asiala. 2015. Reducing Respondent Burden in the American Community Survey. Accessed 8/1/2017 at, https://www.census.gov/content/dam/Census/programs-surveys/acs/operations-and-administration/2015-16-survey-enhancements/Reducing_Burden_ACS_Feasibility_Assessment.pdf. Hughes, Todd, Eric Slud, Robert Ashmead, and Rachael Walsh. 2016. Results of a Field Pilot to Reduce Respondent Contact Burden in the American Community Survey's Computer Assisted Personal Interviewing Operation. ACS16-RER-07. U.S. Census Bureau. Accessed 8/1/2017 at, https://www.census.gov/library/working-papers/2016/acs/2016_Hughes_01.html. National Academies of Sciences, Engineering, and Medicine. (2016). Reducing Response Burden in the American Community Survey: Processing of a Workshop. Washington, DC: The National Academies Press. Accessed 8/1/2017 at, https://doi.org/10.17226/23639. Oliver, Broderick, Michael Risley, and Andrew Roberts. 2016. 2015 Summer Mandatory Messaging Test. ACS16-RER-5-R1. U.S. Census Bureau. Accessed 8/1/2017 at, https://www.census.gov/library/working-papers/2016/acs/2016_Oliver_01.html. U.S. Census Bureau. 2017. Agility in Action 2.0: A Snapshot of enhancements to the American Community Survey. Accessed 8/8/2017 at, https://www.census.gov/programs-surveys/acs/operations-and-administration/agility-in-action/agility-in-action-2.html. II. Method of Collection

    Self-Response Mail Messaging Tests—We will use the same self-response modes we offer in ACS production data collection, that is, internet and a mail-back paper questionnaire. No interviewer-administered interviews are necessary for these tests. Different strategies to encourage self-response may be used, including changes to the number and timing of the mailings, the messages and materials included in each mailing, as well as automated telephone reminders. Testing is usually conducted with split-sample experiments, using current ACS production materials as the control. The Census Bureau expects to conduct up to four self-response mail messaging tests each year.

    Respondent Burden Field Test—The Census Bureau proposes adding several optional questions about the respondent's perception of burden at the end of the ACS interview. The questions would allow respondents the opportunity to give feedback after completing the ACS and are intended to measure the burden of the survey, including the contacts we made to reach the respondent, the time it took to complete the survey, and how difficult and sensitive it was for the respondent to answer the questions. The questions would be asked of respondents across all modes of data collection: Internet, paper questionnaires, and interviewer-administered.

    Testing the Use of Administrative Data in Housing Units (HUs) and GQs—We will test replacing or substituting all or parts of the ACS with administrative data, which could make it possible to remove or modify the existing questions on the questionnaire. Respondents could be presented with a new version of the questionnaire with some questions not asked and others modified, as compared to production ACS. Evidence suggests that respondents who respond to the ACS using different modes of data collection (internet, paper questionnaire, and interviewer-administered) have different socioeconomic characteristics. Therefore, this test will include all modes of data collection. This test would include respondents in both HUs and GQs.

    Group Quarters Test—A sample of GQ respondents will be given the option of completing the survey via self-response using an internet instrument. We would evaluate the quality of the data received from the internet compared to traditional data collection methods for GQs (paper questionnaires and interviewer-administered) as well as assess operational issues with offering the internet option, including feedback from interviewers.

    Content Tests—The self-response content test will include internet and paper-questionnaires for data collection. Additionally, assistance over the phone will be offered to respondents, which can result in an interview being conducted. These interviews are considered self-response in the ACS. The test will be a split-sample experiment with some respondents assigned to receive current production ACS content and some respondents assigned to receive new and revised content. Additionally, a follow-up reinterview may be conducted with all households who responded to measure response burden as well as response bias or response variance. Comparisons will be made between the experimental treatments to determine whether the new or revised content produces better data quality and/or reduces respondent burden. The 2021 ACS Content Test will be similar to the self-response content test in that it will be a split-sample experiment with a follow-up reinterview. However, this test will include all modes of data collection (internet, mail, and interviewer-administered).

    III. Data

    OMB Control Number: 0607-0936.

    Form Number(s): ACS-1, ACS-1(GQ), ACS-1(PR)SP, ACS CAPI(HU) and ACS RI(HU).

    Type of Review: Regular submission.

    Affected Public: Individuals and households.

    Estimated Number of Respondents:

    Self-Response Mail Messaging Tests—We estimate that each of the self-response mail messaging tests will include 60,000 respondents. We anticipate there will be up to 14 tests across the 3-year period.

    Respondent Burden Field Test—100,000.

    Testing the Use of Administrative Data—100,000.

    Self-Response Content Test—100,000 respondents plus 63,000 respondents in the follow-up reinterview.

    2021 ACS Content Test—100,000 respondents plus 83,000 respondents in the follow-up reinterview.

    Estimated Time per Response:

    Self-Response Mail Messaging Tests—40 minutes.

    Respondent Burden Field Test—50 minutes (10 minutes for the optional follow-up questions).

    Testing the Use of Administrative Data in HUs and GQs—40 minutes.

    Group Quarters Test—40 minutes (includes both the interview with the facility manager and the interview itself).

    Self-Response Content Test—40 minutes for the initial interview plus 20 minutes for the follow-up reinterview.

    2021 ACS Content Test—40 minutes for the initial interview plus 20 minutes for the follow-up reinterview.

    Estimated Total Annual Burden Hours: 297,445.

    Test Estimated number of respondents Estimated time per response
  • (in minutes)
  • Total burden hours
    2018 Self-Response Mail Messaging Tests Test A—60,000
  • Test B—60,000
  • Test A—40
  • Test B—40
  • Test A—40,000.
  • Test B—40,000.
  • 2019 Self-Response Mail Messaging Tests Test A—60,000
  • Test B—60,000
  • Test C—60,000
  • Test D—60,000
  • Test A—40
  • Test B—40
  • Test C—40
  • Test D—40
  • Test A—40,000.
  • Test B—40,000.
  • Test C—40,000.
  • Test D—40,000.
  • 2020 Self-Response Mail Messaging Tests Test A—60,000
  • Test B—60,000
  • Test C—60,000
  • Test D—60,000
  • Test A—40
  • Test B—40
  • Test C—40
  • Test D—40
  • Test A—40,000.
  • Test B—40,000.
  • Test C—40,000.
  • Test D—40,000.
  • 2021 Self-Response Mail Messaging Tests Test A—60,000
  • Test B—60,000
  • Test C—60,000
  • Test D—60,000
  • Test A—40
  • Test B—40
  • Test C—40
  • Test D—40
  • Test A—40,000.
  • Test B—40,000.
  • Test C—40,000.
  • Test D—40,000.
  • Respondent Burden Field Test 100,000 50 83,334. Testing the Use of Administrative Data in HUs and GQs 100,000 40 66,667. Group Quarters Test 500 40 334. Self-Response Content Test Initial Interview—100,000 Initial Interview—40 Initial Interview—66,667. Follow-up Reinterview—63,000 Follow-up Reinterview—20 Follow-up Reinterview—21,000. 2021 ACS Content Test Initial Interview—100,000 Initial Interview—40 Initial Interview—66,667. Follow-up Reinterview—83,000 Follow-up Reinterview—20 Follow-up Reinterview—27,667. Total 1,386,500 892,336 (over 3 years).

    Estimated Total Annual Cost to Public: Except for their time, there is no cost to respondents.

    Respondent's Obligation: Mandatory.

    Legal Authority: Title 13 U.S.C. Sections 141 and 193.

    IV. Request for Comments

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

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

    Sheleen Dumas, Departmental PRA Lead, Office of the Chief Information Officer.
    [FR Doc. 2017-24943 Filed 11-16-17; 8:45 am] BILLING CODE 3510-07-P
    DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [B-69-2017] Foreign-Trade Zone (FTZ) 52—Suffolk County, New York; Notification of Proposed Production Activity; Estee Lauder Inc., (Hair Straightening Styling Balm), Melville, New York

    Estee Lauder Inc. (Estee Lauder) submitted a notification of proposed production activity to the FTZ Board for its facilities in Melville, New York within FTZ 52. The notification conforming to the requirements of the regulations of the FTZ Board (15 CFR 400.22) was received on November 2, 2017.

    Estee Lauder already has authority to manufacture and distribute skin care, fragrance, and cosmetic products within FTZ 52. The current request would add a finished product (hair straightening styling balm) to the scope of authority. Pursuant to 15 CFR 400.14(b), additional FTZ authority would be limited to the finished product described in the submitted notification (as described below) and subsequently authorized by the FTZ Board.

    Production under FTZ procedures could exempt Estee Lauder from customs duty payments on the foreign-status materials/components used in export production. On its domestic sales, for foreign-status materials/components in the existing scope of authority, Estee Lauder would be able to choose the duty rate during customs entry procedures that applies to hair straightening styling balm (duty-free). Estee Lauder would be able to avoid duty on foreign-status components which become scrap/waste. Customs duties also could possibly be deferred or reduced on foreign-status production equipment.

    Public comment is invited from interested parties. Submissions shall be addressed to the Board's Executive Secretary at the address below. The closing period for their receipt is December 27, 2017.

    A copy of the notification will be available for public inspection at the Office of the Executive Secretary, Foreign-Trade Zones Board, Room 21013, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230-0002, and in the “Reading Room” section of the Board's Web site, which is accessible via www.trade.gov/ftz.

    For further information, contact Juanita Chen at [email protected] or (202) 482-1378.

    Dated: November 13, 2017. Andrew McGilvray, Executive Secretary.
    [FR Doc. 2017-24972 Filed 11-16-17; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [C-552-819] Certain Steel Nails From the Socialist Republic of Vietnam: Notice of Rescission of Countervailing Duty Administrative Review, 2016 AGENCY:

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

    SUMMARY:

    The Department of Commerce (the Department) is rescinding the administrative review of the countervailing duty (CVD) order on certain steel nails (steel nails) from the Socialist Republic of Vietnam (Vietnam) for the period January 1, 2016, to December 31, 2016, based on the timely withdrawal of the request for review.

    DATES:

    Applicable November 17, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Yasmin Bordas, 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) 482-3813 and (202) 482-7438, respectively.

    SUPPLEMENTARY INFORMATION: Background

    On July 3, 2017, the Department published in the Federal Register a notice of opportunity to request an administrative review of the CVD order on steel nails from Vietnam for the period January 1, 2016, to December 31, 2016.1 On July 31, 2017, the Department received a timely request, in accordance with section 751(a) of the Tariff Act of 1930, as amended (the Act), from Mid Continent Steel & Wire Inc. (the petitioner) to conduct an administrative review of this CVD order with respect to 14 companies.2 Based upon this request, on September 13, 2017, in accordance with section 751(a) of the Act, the Department published in the Federal Register a notice of initiation of administrative review for this CVD order.3 On September 28, 2017, the petitioner timely withdrew its request for an administrative review for each of the 14 companies.4

    1 See Antidumping or Countervailing Duty Order, Finding, or Suspended Investigation; Opportunity to Request Administrative Review, 82 FR 30833 (July 3, 2017).

    2See Letter from the petitioner re: Certain Steel Nails from Vietnam: Request for Administrative Reviews, dated July 31, 2017.

    3See Initiation of Antidumping and Countervailing Duty Administrative Reviews, 82 FR 42974 (September 13, 2017) (Initiation Notice).

    4See Letter from the petitioner re: Certain Steel Nails from Vietnam: Withdrawal of Request for Administrative Reviews, dated September 28, 2017.

    Rescission of Review

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

    Assessment

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

    Notification 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 countervailing 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 countervailing duties occurred and the subsequent assessment of doubled countervailing duties.

    Notification Regarding Administrative Protective Order

    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 an APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of the return/destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction. This notice is issued and published in accordance with sections 751 of the Act and 19 CFR 351.213(d)(4).

    Dated: November 13, 2017. James Maeder, Acting Deputy Assistant Secretary for Antidumping/Countervailing Duty Operations Enforcement and Compliance (E&C).
    [FR Doc. 2017-24967 Filed 11-16-17; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration Notice of Meeting: Summit on Trade-Related Standards Issues ACTION:

    Request for public comments and notice of opportunity to apply to participate in an internal International Trade Administration summit on trade-related standards issues.

    SUMMARY:

    The Department of Commerce International Trade Administration (ITA) is seeking input from U.S. stakeholders (companies, private sector organizations and trade associations active in trade-related standards work) on standards, conformity assessment and regulatory trends and challenges in foreign markets and the assistance they require from ITA to effectively address standards-related trade barriers and trends to take advantage of export opportunities. ITA will use this input in reviewing how to improve services and programs to best meet the needs of U.S. stakeholders in the standards area. In addition, ITA will convene an internal summit on how to improve such services and programs on March 6-7, 2018 in Washington, DC, and is soliciting private sector requests for limited opportunities to participate in portions of the summit.

    DATES:

    Although input is always welcome, for consideration as part of the immediate review, submit comments by December 18, 2017. Requests to participate in the March 6-7, 2018 ITA internal summit also must be received by COB on December 18, 2017.

    ADDRESSES:

    Comments can be submitted online or in writing. Written submissions should be directed to Renee Hancher, Office of Standards and Investment Policy, Industry and Analysis, U.S. Department of Commerce, Room 28019, 14th and Constitution Avenue NW., Washington, DC 20230. Online submissions should be submitted using http://www.regulations.gov. To ensure the timely receipt and consideration of comments, ITA strongly encourages commenters to make online submissions using http://www.regulations.gov. Comments should be submitted under docket ITA-2017-0007.

    FOR FURTHER INFORMATION CONTACT:

    Contact Renee Hancher in the Office of Standards and Investment Policy, Industry and Analysis, International Trade Administration, by telephone at (202) 482-3493 (this is not a toll-free number) or email at [email protected]

    SUPPLEMENTARY INFORMATION:

    Background: The International Trade Administration (ITA) is the premier resource for American companies competing in the global marketplace. ITA has more than 2,200 employees assisting U.S. exporters in more than 100 U.S. cities and 75 markets worldwide. For more information on ITA visit www.trade.gov. Additional information about ITA's standards activities is available at http://www.trade.gov/td/standards/index.html.

    Request for Input: ITA is currently reviewing its trade-related standards services and programs in support of U.S. stakeholders to ensure that the services and assistance provided best meet the needs of U.S. stakeholders and support the expansion of the U.S. economy and creation of U.S. jobs. Trade-related standards work includes work related to the adoption and recognition of standards; standards dialogues and other bilateral and regional engagements with trading partners; preparation of standards information in ITA publications such as Top Market reports and Country Commercial Guides; and work to address adoption, implementation, and enforcement of technical regulations and conformity assessment procedures inconsistent with World Trade Organization and free trade agreement obligations. ITA is specifically seeking information on trade-related standards trends in foreign markets, the challenges U.S. exporters are encountering in those markets, and the assistance needed from the U.S. Government, and specifically ITA, to address those challenges and take advantage of export opportunities. ITA will use this input in reviewing how to improve ITA standards-related services and programs to best meet the needs of U.S. stakeholders, including during an internal summit of ITA staff working on trade-related standards issues on March 6-7, 2018 in Washington, DC.

    Comments submitted may include information about key standards trends affecting the global competitiveness of U.S. industry; stakeholder experiences, if any, with ITA services that aid stakeholders in understanding and acting on standards-related trade and regulatory issues; and suggestions for improving ITA services in the standards area. Respondents do not need to have detailed knowledge of or experience with ITA standards-related services, but those that do may note this in their submissions.

    Submitting Comments Using http://www.regulations.gov: To find the correct docket, enter ITA-2017-0007 in the “Enter Keyword or ID” window at the http://www.regulations.gov home page and click “Search.” The site will provide a search-results page listing all documents associated with the docket number. Find a reference to this notice by selecting “Notice” under “Document Type” on the search-results page, and click on the link entitled “Comment now!” The http://www.regulations.gov Web site provides the option of making submissions by filling in a comment field, or by attaching a document. ITA prefers submissions to be provided in an attached document. (For further information on using http://www.regulations.gov, please consult the resources provided on the Web site by clicking on the “Help” tab.)

    Do not include any privileged or confidential business information in comments submitted. The file name should begin with the character “P” (signifying that the comments contain no privileged or confidential business information and can be posted publicly), followed by the name of the person or entity submitting the comments. Written submissions should include an original and five (5) copies.

    Please do not attach separate cover letters to electronic submissions; rather, include any information that might appear in a cover letter in the comments themselves. Similarly, to the extent possible, please include any exhibits, annexes, or other attachments in the same file as the submission itself, not as separate files.

    Opportunity to present during the ITA Internal Summit: The Summit will convene ITA staff from headquarters and the domestic and foreign fields to develop recommendations for improving standards-related services and programs for ITA stakeholders. It will include “open sessions” with private sector stakeholders where they may share their priorities and recommendations for ITA's work on trade-related standards issues. To accommodate as many stakeholders as possible, the time per stakeholder will be limited. Stakeholders interested in presenting during a summit open session must apply by December 18, 2017, identifying the name and address of the proposed speaker and including a brief description of the stakeholder interest and intended remarks. Stakeholders are limited to one presenter per company or organization.

    In seeking private sector presenters, ITA will consider factors such as: (1) Frequency and type of standards-related trade barriers experienced with the goal of selecting presenters with significant experience working to overcome standards-related barriers in foreign markets, and whose experience represents the spectrum of such barriers experienced by U.S. exporters (e.g., challenges with standards development, testing and conformity assessment, and meeting standards-related regulatory requirements in foreign markets); and (2) balance of industries and roles with the goal of selecting presenters that represent a mix of industries affected by standards-related trade barriers, and who are conversant on issues affecting U.S. stakeholders/exporters (standards development, conformity assessment, and technical regulations).

    Chris Rosettie, Director, Office of Standards and Investment Policy.
    [FR Doc. 2017-24605 Filed 11-16-17; 8:45 am] BILLING CODE 3510-DR-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-201-836] Light-Walled Rectangular Pipe and Tube From Mexico: Initiation and Expedited Preliminary Results of Changed Circumstances Review AGENCY:

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

    SUMMARY:

    The Department of Commerce (Department) is simultaneously initiating and issuing the preliminary results of a changed circumstances review (CCR) of the antidumping duty order on light-walled rectangular pipe and tube (LWRPT) from Mexico, consistent with section 751(b) of the Tariff Act of 1930, as amended (the Act) and 19 CFR 351.216 and 351.221(c)(3)(ii). Based on the information on the record, we preliminarily determine that Perfiles LM, S.A. de C.V. (Perfiles) is the successor-in-interest to Perfiles y Herrajes LM, S.A. de C.V. (Perfiles y Herrajes). Interested parties are invited to comment on these preliminary results.

    DATES:

    Applicable November 17, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Madeline R. Heeren, AD/CVD Operations, Office VI, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-9179.

    SUPPLEMENTARY INFORMATION:

    Background

    On August 5, 2008, the Department published the antidumping duty order on LWRPT from Mexico.1 On July 31, 2017, Perfiles y Herrajes informed the Department that, effective July 11, 2017, it had changed its name to ” Perfiles LM, S.A. de C.V.,” (i.e., Perfiles) and requested that the Department conduct a CCR under 19 CFR 351.216(b) to determine that Perfiles is the successor-in-interest to Perfiles y Herrajes for purposes of determining Perfiles' antidumping duty cash deposits and liabilities.2

    1See Light-Walled Rectangular Pipe and Tube from Mexico, the People's Republic of China, and the Republic of Korea: Antidumping Duty Orders; Light-Walled Rectangular Pipe and Tube from the Republic of Korea: Notice of Amended Final Determination of Sales at Less Than Fair Value, 73 FR 45403 (August 5, 2008) (Order).

    2See Letter, “Light-Walled Rectangular Pipe and Tube from Mexico—Notice of Change in Company Name,” dated July 31, 2017 (CCR Request).

    On August 17, 2017, the Department declined to initiate the CCR that Perfiles y Herrajes requested, citing the need for additional information pertaining to any changes in management, production facilities, customers, and suppliers.3 Therefore, the Department issued Perfiles y Herrajes a questionnaire. On October 2, 2017, Perfiles y Herrajes filed its response, in which it provided additional information to support its request.4 We have received no comments from any other interested party.

    3See Letter, “Light-Walled Rectangular Pipe and Tube from Mexico: Antidumping Duty Changed Circumstances Review Deficiency Questionnaire,” dated August 17, 2017 (CCR Questionnaire).

    4See Letter, “Light-Walled Rectangular Pipe and Tube from Mexico—Response to August 17 Questionnaire,” dated October 2, 2017 (CCR Questionnaire Response).

    Scope of the Review

    The merchandise subject to this order is certain welded carbon-quality light-walled steel pipe and tube, of rectangular (including square) cross section, having a wall thickness of less than 4 mm.

    The term carbon-quality steel includes both carbon steel and alloy steel which contains only small amounts of alloying elements. Specifically, the term carbon-quality includes products in which none of the elements listed below exceeds the quantity by weight respectively indicated: 1.80 percent of manganese, or 2.25 percent of silicon, or 1.00 percent of copper, or 0.50 percent of aluminum, or 1.25 percent of chromium, or 0.30 percent of cobalt, or 0.40 percent of lead, or 1.25 percent of nickel, or 0.30 percent of tungsten, or 0.10 percent of molybdenum, or 0.10 percent of niobium, or 0.15 percent vanadium, or 0.15 percent of zirconium.

    The description of carbon-quality is intended to identify carbon-quality products within the scope. The welded carbon-quality rectangular pipe and tube subject to this order is currently classified under the Harmonized Tariff Schedule of the United States (HTSUS) subheadings 7306.61.50.00 and 7306.61.70.60. While HTSUS subheadings are provided for convenience and customs purposes, our written description of the scope of this order is dispositive.5

    5 For a complete description of the scope of the order, see Memorandum, “Light-Walled Rectangular Pipe and Tube from Mexico: Initiation and Expedited Preliminary Results of Changed Circumstances Review,” dated concurrently with, and hereby adopted by, these preliminary results (Preliminary Decision Memorandum).

    Initiation of Changed Circumstances Review

    Pursuant to section 751(b)(1) of the Act and the Department's regulations (19 CFR 351.216 and 351.221(c)(3)), the Department will conduct a CCR upon receipt of information concerning, or a request from an interested party for a review of, an order which shows changed circumstances sufficient to warrant a review of the order. Generally, in the past, the Department has used CCRs to address the applicability of cash deposit rates after there have been changes in the name or structure of a respondent, such as a merger or spinoff (i.e., successor-in-interest, or successorship determinations).6

    6See, e.g., Crystalline Silicon Photovoltaic Cells, Whether or Not Assembled Into Modules, from the People's Republic of China: Final Results of Changed Circumstances Review, 81 FR 91909 (December 19, 2016) (Solar Cells PRC 2016 CCR Final).

    Perfiles y Herrajes states that, effective July 11, 2017, Perfiles y Herrajes changed its name to Perfiles.7 Consistent with Department practice, as further discussed in the Preliminary Decision Memorandum, we find that the information submitted by Perfiles y Herrajes demonstrates changed circumstances sufficient to warrant a review.8 Therefore, in accordance with section 751(b)(1) of the Act and 19 CFR 351.216(d), the Department is initiating a CCR to determine whether Perfiles is the successor-in-interest to Perfiles y Herrajes.

    7See CCR Request at 1.

    8See 19 CFR 351.216(d).

    Preliminary Results

    When it concludes that expedited action is warranted, the Department may publish the notice of initiation and preliminary results of a CCR in a single notice.9 The Department has combined the notice of initiation and preliminary results in successor-in-interest cases when sufficient documentation has been provided supporting the request to make a preliminary determination.10 In this instance, because the record contains information necessary to support the request for a preliminary determination, we find that expedited action is warranted, and we are combining the notice of initiation and the notice of preliminary results, in accordance with 19 CFR 351.221(c)(3)(ii).

    9See 19 CFR 351.221(c)(3)(ii).

    10See, e.g., Initiation and Preliminary Results of Antidumping Duty Changed Circumstances Review: Crystalline Silicon Photovoltaic Cells, Whether or Not Assembled Into Modules, from the People's Republic of China, 81 FR 76561 (November 3, 2016), unchanged in Solar Cells PRC 2016 CCR Final.

    In a CCR, we generally consider a company to be the successor-in-interest to another company for antidumping cash deposit purposes if the operations of the successor-in-interest are not materially dissimilar from those of its predecessor.11 In making this determination, the Department examines a number of factors including, but not limited to, changes in: (1) Management; (2) production facilities; (3) suppliers; and (4) customer base.12 While no one or several of these factors will necessarily provide a dispositive indication of succession, the Department will generally consider one company to be the successor-in-interest to another company if its resulting operation is essentially the same as that of its predecessor.13 Thus, if the evidence demonstrates that, with respect to the production and sale of the subject merchandise, the new company operates as the same business entity as the prior company, the Department will assign the new company the cash deposit rate of its predecessor.14

    11Id.

    12See Initiation and Preliminary Results of Antidumping Duty Changed Circumstances Review: Multilayered Wood Flooring from the People's Republic of China, 79 FR 48117, 48118 (August 15, 2014), unchanged in Multilayered Wood Flooring from the People's Republic of China: Final Results of Changed Circumstances Review, 79 FR 58740 (September 30, 2014).

    13Id.

    14See Solar Cells PRC 2016 CCR Final, 81 FR at 91910.

    In its CCR Questionnaire Response, Perfiles y Herrajes provided evidence demonstrating that Perfiles' operations are not materially dissimilar from those of its predecessor, Perfiles y Herrajes.15 Specifically, the record indicates that there have not been any material changes to management,16 production facilities,17 suppliers,18 or customer base.19 Based on the foregoing findings, which are explained in greater detail in the Preliminary Decision Memorandum,20 the Department preliminarily determines that Perfiles is the successor-in-interest to Perfiles y Herrajes and, as such, it is entitled to Perfiles y Herrajes' antidumping cash deposit rate with respect to entries of subject merchandise. Should our final results remain the same as these preliminary results, we will instruct U.S. Customs and Border Protection to suspend liquidation of entries of LWRPT produced and/or exported by Perfiles and apply the antidumping cash deposit rate applicable to Perfiles y Herrajes, effective the date of publication of the final results.

    15See Letter, “Light-Walled Rectangular Pipe and Tube from Mexico—Response to August 17 Questionnaire,” dated October 2, 2017 (CCR Questionnaire Response).

    16Id. at 5-6, Appendices A-3-A, A-3-B, A-4-A, and A-4-B.

    17Id. at 9-10, Appendices A-7-A, A-7-B, and A-7-C.

    18Id. at 11, Appendices A-8-A, and A-8-B.

    19Id. at 8, Appendices A-6-A, and A-6-B.

    20See Preliminary Decision Memorandum.

    Public Comment

    Interested parties may submit case briefs not later than 30 days after the date of publication of this notice.21 Rebuttal briefs, limited to issues raised in the case briefs, may be filed by no later than five days after the deadline for filing case briefs.22 Parties who submit case or rebuttal briefs in this CCR are requested to submit with each argument: (1) A statement of the issue; and (2) a brief summary of the argument with an electronic version included.23

    21See 19 CFR 321.309(c)(1)(ii).

    22See 19 CFR 351.309(d)(1).

    23See 19 CFR 351.309(c)(2) and (d)(2).

    Any interested party may request a hearing within 30 days of publication of this notice.24 Hearing requests should contain the following information: (1) The party's name, address, and telephone number; (2) the number of participants; and (3) a list of the issues to be discussed. Oral presentations at the hearing will be limited to issues raised in the briefs. If a request for a hearing is made, parties will be notified of the time and date for the hearing to be held at the U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230 in a room to be determined.25

    24See 19 CFR 351.310(c).

    25See 19 CFR 351.310(d).

    All submissions, with limited exceptions, must be filed electronically using Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). An electronically filed document must be received successfully in its entirety by 5 p.m. Eastern Time (ET) on the due date. Documents excepted from the electronic submission requirements must be filed manually (i.e., in paper form) with the APO/Dockets Unit in Room 18022 and stamped with the date and time of receipt by 5 p.m. ET on the due date.26

    26See Antidumping and Countervailing Duty Proceedings: Electronic Filing Procedures: Administrative Protective Order Procedures, 76 FR 39263 (July 6, 2011).

    Unless extended, consistent with 19 CFR 351.216(e), we intend to issue the final results of this CCR no later than 270 days after the date on which this review was initiated or within 45 days if all parties agree to the outcome of the review. We intend to issue and publish this initiation and preliminary results notice in accordance with sections 751(b)(1) and 777(i)(1) of the Act and 19 CFR 351.216 and 351.221(c)(3) of the Department's regulations.

    Dated: November 13, 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. 2017-24965 Filed 11-16-17; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-570-918] Steel Wire Garment Hangers From the People's Republic of China: Final Results of Antidumping Duty Administrative Review; 2015-2016 AGENCY:

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

    SUMMARY:

    On August 9, 2017, the Department of Commerce (Department) published in the Federal Register the Preliminary Results of the administrative review of the antidumping duty order on Steel Wire Garment Hangers from the People's Republic of China (PRC) covering the period October 1, 2015, through September 30, 2016. This review covered Hangzhou Yingqing Material Co. Ltd. and Hangzhou Qingqing Mechanical Co. Ltd. (collectively, Yingqing), and Shanghai Wells Hanger Co., Ltd./Hong Kong Wells Ltd. (collectively, Shanghai Wells).

    The Department gave interested parties an opportunity to comment on the Preliminary Results, but we received no comments. Hence, the final results are unchanged from the Preliminary Results and we continue to find that Shanghai Wells sold merchandise at prices below the normal value and Yingqing is not eligible for a separate rate during the period of review.

    DATES:

    Applicable November 17, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Katrina Clemente, AD/CVD Operations, Office V, Enforcement and Compliance, International Trade Administration, Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-0783.

    SUPPLEMENTARY INFORMATION:

    Background

    On August 9, 2017, the Department published the Preliminary Results and gave interested parties an opportunity to comment.1 The Department received no comments. The Department conducted this review in accordance with section 751(a)(1)(B) of the Tariff Act of 1930, as amended (the Act).

    1See Steel Wire Garment Hangers from the People's Republic of China: Preliminary Results of Antidumping Duty Administrative Review; 2015-2016, 82 FR 37194 (September 9, 2017) (Preliminary Results) and the accompanying Preliminary Decision Memorandum.

    Scope of the Order

    The merchandise subject to the order is steel wire garment hangers, fabricated from carbon steel wire, whether or not galvanized or painted, whether or not coated with latex or epoxy or similar gripping materials, and/or whether or not fashioned with paper covers or capes (with or without printing) and/or nonslip features such as saddles or tubes. These products may also be referred to by a commercial designation, such as shirt, suit, strut, caped, or latex (industrial) hangers. Specifically excluded from the scope of the order are wooden, plastic, and other garment hangers that are not made of steel wire. Also excluded from the scope of the order are chrome-plated steel wire garment hangers with a diameter of 3.4 mm or greater. The products subject to the order are currently classified under HTSUS subheadings 7326.20.0020, 7323.99.9060, and 7323.99.9080.

    Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of the merchandise is dispositive.

    Final Results of Review

    In the Preliminary Results, the Department determined the following: (1) Shanghai Wells sold merchandise at prices below normal value; and (2) Yingqing is not eligible for a separate rate and, therefore, is a part of the PRC-wide entity.2 We have not received information contradicting our preliminary finding; thus, the Department finds there is no reason to modify its analysis. Accordingly, no decision memorandum accompanies this Federal Register notice. For further details of the issues addressed in this proceeding, see the Preliminary Results. 3

    2See Preliminary Results, 82 FR at 37194-95.

    3Id.

    PRC-Wide Entity

    The Department's policy regarding the conditional review of the PRC-wide entity applies to this administrative review.4 Under this policy, the PRC-wide entity will not be under review unless a party specifically requests, or the Department self-initiates, a review of the entity. Because no party requested a review of the PRC-wide entity in this review, the entity is not under review and the entity's rate is not subject to change (i.e., 187.25 percent).5

    4See Antidumping Proceedings: Announcement of Change in Department Practice for Respondent Selection in Antidumping Duty Proceedings and Conditional Review of the Nonmarket Economy Entity in NME Antidumping Duty Proceedings, 78 FR 65963 (November 4, 2013).

    5See Steel Wire Garment Hangers from the People's Republic of China: Final Results of Antidumping Duty Administrative Review, 2012-2013, 80 FR 13332, (March 13, 2015), and accompanying Issues and Decision Memorandum; see also Preliminary Decision Memorandum.

    Methodology

    The Department conducted this review in accordance with section 751(a)(1)(B) of the Act. In the Preliminary Results, the Department calculated constructed export prices and export prices in accordance with section 772 of the Act. Because the PRC is a nonmarket economy (NME) within the meaning of section 771(18) of the Act, normal value is calculated in accordance with section 773(c) of the Act. We have not received any information since the issuance of the Preliminary Results that provides a basis for reconsidering this determination. For a full description of the methodology underlying our conclusions, see the Preliminary Decision Memorandum, available at http://enforcement.trade.gov/frn/.

    Final Results of Review Margin

    The Department determines that the following weighted-average dumping margin exists for the POR from October 1, 2015, through September 30, 2016:

    Exporter Weighted-
  • average
  • dumping
  • margin
  • (%)
  • Shanghai Wells Hanger Co., Ltd./Hong Kong Wells Ltd.6 5.02
    Assessment Rates

    6 As previously stated, we continue to find Shanghai Wells Hanger Co., Ltd. and Hong Kong Wells Ltd. (collectively Shanghai Wells) to be a single entity.

    Pursuant to section 751(a)(2)(C) of the Act and 19 CFR 351.212(b), the Department has determined, and CBP shall assess, antidumping duties on all appropriate entries of subject merchandise in accordance with the final results of this review. The Department intends to issue assessment instructions to CBP 15 days after the publication date of the final results of this review.

    The Department applied the assessment rate calculation method adopted in Final Modification for Reviews, i.e., on the basis of monthly average-to-average comparisons using only the transactions associated with that importer with offsets being provided for non-dumped comparisons.7 Pursuant to the Department's NME practice, for sales that were not reported in the U.S. sales data submitted by companies individually examined during this review, the Department instructs CBP to liquidate entries associated with those sales at the rate for the PRC-wide entity.8

    7See Antidumping Proceeding: Calculation of the Weighted-Average Dumping Margin and Assessment Rate in Certain Antidumping Proceedings; Final Modification, 77 FR 8101, 8103 (February 14, 2012) (Final Modification for Reviews).

    8 For a full discussion of this practice, see Assessment Practice Refinement, 76 FR at 65694 (October 24, 2011).

    Cash Deposit Requirements

    The following cash deposit requirements will be effective upon publication of the final results of this administrative review for all shipments of the subject merchandise from the PRC entered, or withdrawn from warehouse, for consumption on or after the publication date, as provided by section 751(a)(2)(C) of the Act: (1) For the company listed above, Shanghai Wells, the cash deposit rate will be that established in the final results of this review (except, if the rate is zero or de minimis, then zero cash deposit will be required); (2) for previously investigated or reviewed PRC and non-PRC exporters not listed above that have separate rates, the cash deposit rate will continue to be the exporter-specific rate published for the most recently completed segment of this proceeding in which they were reviewed; (3) for all PRC exporters of subject merchandise that have not been found to be entitled to a separate rate, the cash deposit rate will be equal to the weighted-average dumping margin for the PRC-wide entity (i.e., 187.25 percent); and (4) for all non-PRC exporters of subject merchandise which have not received their own separate rate, the cash deposit rate will be the rate applicable to the PRC exporter(s) that supplied that non-PRC exporter. These cash deposit requirements, when imposed, shall remain in effect until further notice.

    Notification to Importers

    This notice also serves as a preliminary reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the Department's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.

    Notification Regarding Administrative Protective Orders

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

    This notice of the final results of this administrative review is issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Act, and 19 CFR 351.221(b)(5) and 19 CFR 351.213(h).

    Dated: November 13, 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. 2017-24964 Filed 11-16-17; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-570-952] Narrow Woven Ribbon With Woven Selvedge From the People's Republic of China: Final Results of Antidumping Duty Administrative Review; 2015-2016 AGENCY:

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

    SUMMARY:

    On July 19, 2017, the Department of Commerce (the Department) published the preliminary results of the 2015-2016 antidumping duty administrative review (AR) of the antidumping duty order on narrow woven ribbon with woven selvedge from the People's Republic of China (PRC), in accordance with section 751(a)(1)(B) of the Tariff Act of 1930, as amended (the Act). The period of review (POR) is September 1, 2015, through August 31, 2016. We received no comments from any interested parties. Accordingly, our final results remain unchanged from the preliminary results.

    DATES:

    Effective November 17, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Aleksandras Nakutis, AD/CVD Operations, Office IV, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-3147.

    SUPPLEMENTARY INFORMATION:

    Background

    As stated above, on July 19, 2017, the Department published the Preliminary Results1 of the AR of the antidumping duty order on narrow woven ribbon with woven selvedge from the PRC covering the period September 1, 2015, through August 31, 2016, and invited parties to comment on these preliminary results. No parties submitted comments on the Preliminary Results.

    1See Narrow Woven Ribbon with Woven Selvedge from the People's Republic of China: Preliminary Results of Administrative Review and Preliminary Partial Rescission of Antidumping Duty Administrative Review; 2015-2016, 82 FR 33059 (July 19, 2017) (Preliminary Results).

    Scope of the Order

    The products covered by the Order are narrow woven ribbons with woven selvedge. The merchandise subject to the Order is classifiable under the Harmonized Tariff Schedule of the United States (HTSUS) subheadings 5806.32.1020; 5806.32.1030; 5806.32.1050; and 5806.32.1060. Subject merchandise also may enter under HTSUS subheadings 5806.31.00; 5806.32.20; 5806.39.20;5806.39.30; 5808.90.00; 5810.91.00; 5810.99.90; 5903.90.10; 5903.90.25; 5907.00.60l and 5907.00.80 and under statistical categories 5806.32.1080; 5810.92.9080; 5903.90.3090; and 6307.90.9889. Although the HTSUS subheadings are provided for convenience and customs purposes, the written product description in the Order remains dispositive.2

    2 For a complete description of the scope of the order, please see “Decision Memorandum for Preliminary Results of Antidumping Duty Administrative Review: Narrow Woven Ribbons With Woven Selvedge from the People's Republic of China,” from James Maeder, Senior Director performing the duties of Deputy Assistant Secretary for Antidumping and Countervailing Operations, to Gary Taverman, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, performing the non-exclusive functions and duties of the Assistant Secretary for Enforcement and Compliance (Preliminary Decision Memorandum), dated July 12, 2017.

    Analysis

    In the Preliminary Results, the Department preliminarily determined that the two companies under review, Huzhou Kingdom Coating Industry Co., Ltd. (Huzhou Kingdom) and Huzhou Unifull Label Fabric Co., Ltd. (Huzhou Unifull), did not establish their eligibility for separate rate status and would be treated as part of the PRC-wide entity. In these final results of review, we have continued to treat these two companies as part of the PRC-wide entity. For further discussion of the issues addressed in this proceeding, see the Preliminary Results and Preliminary Decision Memorandum. The Preliminary Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at http://access.trade.gov and in the Central Records Unit, Room B8024 of the main Department of Commerce building. In addition, a complete version of the Preliminary Results Decision Memorandum can be accessed directly on the Internet at http://enforcement.trade.gov/frn/index.html. The signed and the electronic versions of the Preliminary Decision Memorandum are identical in content.

    Assessment Rates

    Pursuant to section 751(a)(2)(C) of the Act, and 19 CFR 351.212(b), the Department has determined, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries of subject merchandise in accordance with the final results of this review. The Department intends to issue assessment instructions to CBP 15 days after the publication date of the final results of this review. We intend to instruct CBP to liquidate POR entries of subject merchandise exported by Huzhou Kingdom and Huzhou Unifull at the PRC-wide entity rate, which is 247.26 percent.

    Cash Deposit Requirements

    The following cash deposit requirements will be effective upon publication of the final results of this review for shipments of the subject merchandise from the PRC entered, or withdrawn from warehouse, for consumption on or after the publication date in the Federal Register of the final results of the review, as provided by section 751(a)(2)(C) of the Act: (1) For previously investigated or reviewed PRC and non-PRC exporters not named above that received a separate rate in a prior segment of this proceeding, the cash deposit rate will continue to be the existing exporter-specific rate; (2) for all PRC exporters of subject merchandise that have not been found to be entitled to a separate rate, including Huzhou Kingdom and Huzhou Unifull, the cash deposit rate will be the rate for the PRC-wide entity, which is 247.26 percent; (3) for all non-PRC exporters of subject merchandise which have not received their own rate, the cash deposit rate will be the rate applicable to the PRC exporter that supplied that non-PRC exporter.

    These deposit requirements, when imposed, shall remain in effect until further notice.

    Notification to Importers

    This notice also serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the Department's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.

    Administrative Protective Order

    This notice also serves as a reminder to parties subject to administrative protective order (APO) of their responsibility concerning the return or destruction of proprietary information disclosed under the APO in accordance with 19 CFR 351.305(a)(3), which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of the return/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 of the final results of this antidumping duty administrative review is issued and published in accordance with sections 751(a)(1) and 777(i) of the Act and 19 CFR 351.213 and 19 CFR 351.221(b)(5).

    Dated: November 9, 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. 2017-24966 Filed 11-16-17; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XF824 Western Pacific Fishery Management Council; Public Meeting AGENCY:

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

    ACTION:

    Notice of a public meeting and hearing.

    SUMMARY:

    The Western Pacific Fishery Management Council (Council) will hold Hawaii Regional Ecosystem Advisory Committee (REAC) meeting to discuss and make recommendations on fishery management issues in the Western Pacific Region.

    DATES:

    The Hawaii REAC will meet on Friday, December 1, 2017, between 9 a.m. and 4 p.m. Hawaii Standard Time. For specific times and agendas, see SUPPLEMENTARY INFORMATION.

    ADDRESSES:

    The Hawaii REAC meeting will be held at the Council office, 1164 Bishop St., Suite 1400, Honolulu, HI 96813 and by teleconference and webinar. The teleconference will be conducted by telephone and by web. The teleconference numbers are U.S. toll-free: 1-888-482-3560 or International Access: +1 647 723-3959, and Access Code: 5228220. The webinar can be accessed at: https://wprfmc.webex.com/join/info.wpcouncilnoaa.gov.

    FOR FURTHER INFORMATION CONTACT:

    Kitty M. Simonds, Executive Director, Western Pacific Fishery Management Council; telephone: (808) 522-8220.

    SUPPLEMENTARY INFORMATION:

    Public comment periods will be provided in the agenda. The order in which agenda items are addressed may change. The meetings will run as late as necessary to complete scheduled business.

    Schedule and Agenda for the Hawaii REAC Meeting Friday, December 1, 2017, 9 a.m.—4 p.m. 1. Welcome and Introductions 2. Essential Fish Habitat (EFH) A. Update on Habitat Program B. Review of Non-Fishing Impacts to EFH C. Precious Coral EFH Review 3. Aquaculture Management 4. Public Comment 5. Other Business 6. Discussion and Recommendations Special Accommodations

    The meeting is 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: November 14, 2017. Tracey L. Thompson, Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2017-24960 Filed 11-16-17; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XF846 South Atlantic 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 South Atlantic Fishery Management Council (Council) will hold meetings of the Personnel Committee (Closed Session); Habitat Protection and Ecosystem-Based Management Committee; Spiny Lobster Committee; Citizen Science Committee; Data Collection Committee; Snapper Grouper Committee; Southeast Data, Assessment and Review (SEDAR) Committee (Partially Closed); Mackerel Cobia Committee, Information and Education Committee; Standard Operating, Policy and Procedure (SOPPs) Committee, and the Executive Finance Committee. The Council will meet as a Committee of the Whole to address the Acceptable Biological Catch (ABC) Control Rule and a meeting of the full Council. A Recreational Reporting Workshop will also be held during the meeting week. The Council will also hold a formal public comment session and take action as necessary.

    DATES:

    The Council meetings will be held from 8 a.m. on Monday, December 4, 2017 until 1 p.m. on Friday, December 8, 2017.

    ADDRESSES:

    Meeting address: The meeting will be held at the DoubleTree by Hilton Atlantic Beach Oceanfront, 2717 W. Fort Macon Road, Atlantic Beach, NC 28512; phone: (252) 240-1155; fax: (252) 222-4065.

    Council address: South Atlantic Fishery Management Council, 4055 Faber Place Drive, Suite 201, N. Charleston, SC 29405.

    FOR FURTHER INFORMATION CONTACT:

    Kim Iverson, Public Information Officer, SAFMC; phone (843) 571-4366 or toll free (866) SAFMC-10; fax: (843) 769-4520; email: [email protected] Meeting information is available from the Council's Web site at: http://safmc.net/meetings/council-meetings/.

    SUPPLEMENTARY INFORMATION:

    Public comment: Written comments may be directed to Gregg Waugh, Executive Director, South Atlantic Fishery Management Council (see ADDRESSES) or electronically via the Council's Web site at http://safmc.net/safmc-meetings/council-meetings/. The public comment form is open for use when the briefing book is posted to the Web site on the Friday, two weeks prior to the Council meeting (11/17/17). Comments received by close of business the Monday before the meeting 11/27/17) will be compiled, posted to the Web site as part of the meeting materials, and included in the administrative record; please use the Council's online form available from the Web site. For written comments received after the Monday before the meeting (after 11/27/17), individuals submitting a comment must use the Council's online form available from the Web site. Comments will automatically be posted to the Web site and available for Council consideration. Comments received prior to noon on Thursday, December 7, 2017 will be a part of the meeting administrative record.

    The items of discussion in the individual meeting agendas are as follows:

    Personnel Committee (Closed Session), December 4, 2017, 8 a.m. Until 9 a.m.

    1. The Personnel Committee will meet in Closed Session to discuss personnel issues and provide recommendations for Council consideration.

    Habitat Protection and Ecosystem-Based Management Committee, Monday, December 4, 2017, 9 a.m. Until 11 a.m.

    1. The Committee will receive a report from the Habitat Protection and Ecosystem-Based Management Advisory Panel.

    2. The Committee will review and approve the Implementation Plan for the Fishery Ecosystem-Based Management Plan (FEP II), review and approve the Road Map for the FEP II, review the Dashboard and Tools for the FEP II, receive an update on the Conservation Blueprint 2.2, and provide guidance.

    3. The Committee will receive updates on other Habitat-related issues and provide recommendations as appropriate.

    Committee Meeting of the Whole—Acceptable Biological Catch (ABC) Control Rule, Monday, December 4, 2017, 11 a.m. Until 12:00 noon.

    1. The Council will meet as a Committee of the Whole to discuss the ABC Control Rule Amendment currently under development and provide guidance to staff.

    Spiny Lobster Committee, Monday, December 4, 2017, 1:30 p.m. Until 3 p.m.

    1. The Committee will receive an update on the status of 2016/17 catches versus the annual catch limit (ACLs), and review draft options for Spiny Lobster Amendment 13 addressing bullynets and measures recommended by the Florida Fish and Wildlife Conservation Commission (FWC), and provide recommendations as appropriate.

    Citizen Science Committee, Monday, December 4, 2017, 3 p.m. Until 4:30 p.m.

    1. The Committee will address policy on the Citizen Science Advisory Panel Pool and Action Team appointments and approve for recommendation to Council.

    2. The Committee will receive reports from the Citizen Science Action Teams, discuss items brought forward by the Action Teams, and provide guidance to staff as appropriate.

    3. The Committee will receive an update on the Citizen Science Program partnerships and Pilot Project and provide guidance to staff as needed.

    Data Collection Committee, Monday, December 4, 2017, 4:30 p.m. Until 5:30 p.m.

    1. The Committee will receive status reports on the For-Hire Electronic Reporting Amendment, and the Council's Data Collection Pilot Project and Outreach Plan relative to For-Hire Electronic Reporting. The Committee will provide guidance to staff as necessary.

    Recreational Reporting Workshop, Tuesday, December 5, 2017 From 8:30 a.m. Until 12 p.m.

    1. The Council will receive an update on the red snapper mini-season, and hold a workshop on recreational reporting with presentations on electronic reporting for big game, the iSnapper voluntary reporting program, Tails'n'Scales mandatory reporting program, and state involvement in reporting for the Marine Recreational Informational Reporting Program (MRIP). Discussion of these programs will be held as part of the workshop.

    Snapper Grouper Committee, Tuesday, December 5, 2017, 1:30 p.m. Until 5:30 p.m. and Wednesday, December 6, 2017 From 8:30 a.m. Until 4:30 p.m.

    1. The Committee will receive updates from NOAA Fisheries on commercial and recreational catches versus quotas for species under ACLs and the status of amendments under formal Secretarial review.

    2. The Committee will receive a Report from the Snapper Grouper Advisory Panel.

    3. The Committee will receive an overview of draft Amendment 46 addressing measures for red snapper, review options, and provide guidance to staff.

    4. The Committee will receive an overview Vision Blueprint Regulatory Amendment 26 addressing recreational management actions and alternatives as identified in the 2016-2020 Vision Blueprint for the Snapper Grouper Fishery Management Plan. The Committee will review the revised actions and alternatives, updated analyses, and purpose and need. The Committee will modify the document as necessary and provide guidance to staff.

    5. The Committee will review Vision Blueprint Regulatory Amendment 27 addressing commercial management actions and alternatives, as identified in the 2016-2020 Vision Blueprint for the Snapper Grouper Fishery. The Committee will review recommendations from the Scientific and Statistical Committee (SSC), review revised actions and alternatives, updated analyses, and the purpose and need, modify the document as necessary, and provide guidance to staff.

    6. The Committee will receive presentations from NOAA Fisheries on proposed Exempted Fishing Permits for lionfish and provide recommendations as appropriate.

    7. The Committee will receive an overview on options for draft Amendment 38 addressing management measures for blueline tilefish, receive a presentation on the benchmark stock assessment (SEDAR 50), review fishing level recommendations from the SSC, modify the amendment as necessary, and provide guidance to staff.

    8. The Committee will receive an overview of options for the draft For-Hire Moratorium Amendment, discuss and provide guidance to staff.

    9. The Committee will receive SSC fishing level recommendations for red grouper, review management options, and approve the abbreviated framework document for formal Secretarial Review.

    10. The Committee will receive an overview from staff on golden tilefish management, review recommendations from the SSC, and provide guidance to staff.

    11. The Committee will receive an update on the Wreckfish Individual Transferable Quota (ITQ) review and provide guidance to staff.

    12. The Committee will receive an overview of management issues relative to yellowtail snapper, review a response from the Gulf of Mexico Fishery Management Council on a potential joint amendment to examine jurisdictional annual catch limits, and provide guidance to staff.

    Formal Public Comment, Wednesday, December 6, 2017, 4:30 p.m.—Public comment will be accepted on items on the Council agenda. The Council is also accepting public comment on Executive Order 13771 (2 for 1 regulations) to identify regulations that are (1) outdated, (2) unnecessary, or (3) ineffective. The Council Chair, based on the number of individuals wishing to comment, will determine the amount of time provided to each commenter.

    SEDAR Committee (Partially Closed), Thursday, December 7, 2017, 8:30 a.m. Until 9:30 a.m.

    (Closed Session)

    1. The Committee will make recommendations for appointments to the Cobia Stock Identification Workshop and for appointments to stock assessments for greater amberjack and red porgy.

    (Open Session)

    2. The Committee will receive a report from the SSC.

    3. The Committee will review Terms of Reference and schedules for greater amberjack and red porgy stock assessments and provide recommendations as appropriate.

    4. The Committee will review the SEDAR Steering Committee Report, discuss, and provide guidance as appropriate.

    Mackerel Cobia Committee, Thursday, December 7, 2017, 9:30 a.m. Until 12 p.m.

    1. The Committee will receive an update on commercial and recreational catches versus quotas for species managed under ACLs and an update on the status of amendments currently under Secretarial review.

    2. The Committee will receive an update on development of the Interstate Atlantic Cobia Management Plan from the Atlantic States Marine Fisheries Commission (ASMFC).

    3. The Committee will receive an update on the status of a request for recalculation of the 2015 and 2016 recreational landings for Atlantic cobia.

    4. The Committee will receive an overview of Coastal Migratory Pelagics Framework Amendment 6 addressing Atlantic king mackerel trip limits, discuss, and provide recommendations for approval for public scoping.

    5. The Committee will receive an overview Coastal Migratory Pelagics Amendment 31 addressing proposed management measures for Atlantic cobia, discuss, and provide recommendations for approval for public hearings.

    Information and Education Committee, Thursday, December 7, 2017, 1:30 p.m. Until 2 p.m.

    1. The Committee will receive a report from the Information and Education Advisory Panel, discuss and provide recommendations to staff as appropriate.

    SOPPs Committee, Thursday, December 7, 2017, 2 p.m. Until 3:30 p.m.

    1. The Committee will review policies for inclusion in the SOPPs and/or Council Handbook, discuss and provide direction to staff as appropriate.

    Executive/Finance Committee, Thursday, December 7, 2017, 3:30 p.m. Until 5:30 p.m.

    1. The Committee will receive an overview of the current Magnuson-Stevens Reauthorization efforts, discuss and provide guidance and approval as needed.

    2. The Committee receive an update on the current budget status and outlook, discuss and provide guidance as needed.

    3. The Committee will receive an overview on materials available for Council meetings, discuss, and provide guidance to staff.

    5. The Committee will receive an overview of the System Management Plan Advisory Panel, discuss and provide additional guidance as needed.

    Council Session: Friday, December 8, 2017, 8:30 a.m. Until 1 p.m. (Partially Closed Session if Needed)

    The Full Council will begin with the Call to Order, adoption of the agenda, announcements and introductions, and presentations.

    The Council will receive a Legal Briefing on Litigation from NOAA General Counsel (if needed) during Closed Session. The Council will receive the Executive Director's Report and an update on results from the Northeast Regional Coordinating Council meeting in November. Updates will be provided by NOAA Fisheries including a discussion with Dr. Francisco “Cisco” Werner, Chief Science Advisor and Director of Scientific Programs, reports on the status of commercial and recreational catches versus ACLs for species not covered during an earlier committee meeting, status of Recreational and Commercial Quota Monitoring Tables on the NOAA Fisheries' Southeast Regional Office Web site, a turtle release presentation, and discussion of other issues as necessary. The Council will also receive an update on the status of Bycatch Collection Programs and the pending voluntary commercial electronic logbook reporting effort from NOAA Fisheries' Southeast Fisheries Science Center. The Council will review any Exempted Fishing Permits received by NOAA Fisheries as necessary. The Council will receive Committee reports from the Snapper Grouper, Mackerel Cobia, Spiny Lobster, SEDAR, Data Collection, Habitat and Ecosystem-Based Management, Information and Education, Citizen Science, SOPPs, and Executive Finance Committees; a report from the Committee of the Whole (ABC Control Rule); a report from the Recreational Reporting Workshop; review recommendations; and take action as appropriate.

    The Council will receive agency and liaison reports; and discuss other business and upcoming meetings.

    Documents regarding these issues are available from the Council office (see ADDRESSES).

    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 this meeting. Action will be restricted to those issues specifically identified in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the Council's intent to take final action to address the emergency.

    Special Accommodations

    These meetings are physically accessible to people with disabilities. Requests for auxiliary aids should be directed to the council office (see ADDRESSES) 3 days prior to the meeting.

    Note:

    The times and sequence specified in this agenda are subject to change.

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: November 14, 2017. Tracey L. Thompson, Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2017-24955 Filed 11-16-17; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XF839 New England Fishery Management Council; Public Meeting AGENCY:

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

    ACTION:

    Notice of public meeting.

    SUMMARY:

    The New England Fishery Management Council (Council, NEFMC) will hold a three-day meeting to consider actions affecting New England fisheries in the exclusive economic zone (EEZ).

    DATES:

    The meeting will be held on Tuesday, Wednesday, and Thursday, December 5, 6, and 7, 2017, beginning at 9 a.m. on December 5, 8:30 a.m. on December 6, and 8:30 a.m. on December 7.

    ADDRESSES:

    The meeting will be held at the Hotel Viking, 1 Bellevue Avenue, Newport, RI 02840; telephone: (401) 847-3300; online at www.hotelviking.com.

    Council address: New England Fishery Management Council, 50 Water Street, Mill 2, Newburyport, MA 01950; telephone: (978) 465-0492; www.nefmc.org.

    FOR FURTHER INFORMATION CONTACT:

    Thomas A. Nies, Executive Director, New England Fishery Management Council; telephone: (978) 465-0492, ext. 113.

    SUPPLEMENTARY INFORMATION:

    Agenda Tuesday, December 5, 2017

    After introductions and brief announcements, the meeting will begin with reports from the Council Chairman and Executive Director, NMFS's Regional Administrator for the Greater Atlantic Regional Fisheries Office (GARFO), liaisons from the Northeast Fisheries Science Center (NEFSC) and Mid-Atlantic Fishery Management Council, representatives from NOAA General Counsel and the Office of Law Enforcement, and staff from the Atlantic States Marine Fisheries Commission (ASMFC) and U.S. Coast Guard. Next, the Council will receive a short briefing from the Northeast Regional Ocean Council on upgrades to the Northeast Ocean Data Portal. The Skate Committee will report next with a final item related to Framework Adjustment 5 to the Northeast Skate Complex Fishery Management Plan (FMP). The Council addressed most of the framework components during its September meeting. During this December meeting, the Council will: (1) Consider options to exempt vessels from skate regulations when fishing exclusively within the Northwest Atlantic Fisheries Organization (NAFO) Regulatory Area; and (2) take final action on the entire framework. Then, ASMFC will brief the Council on the Commission's Draft Addendum XXVI to the Interstate Fishery Management Plan for American Lobster and Addendum III to the Jonah Crab plan. The Council will discuss data collection needs for these fisheries. The Habitat Committee then will provide a short progress report on the Council's Coral Amendment and Clam Dredge Framework, which will be followed by a Bureau of Ocean Energy Management overview of proposed and ongoing offshore wind energy projects in the Northeast.

    After the lunch break, GARFO will provide a presentation on the North Atlantic Right Whale Five-Year Review and the reinitiation of formal consultation due to new information on the changed status of right whales. Next, the Atlantic Herring Committee will report on Draft Amendment 8 to the Atlantic Herring FMP. The Council will select preferred alternatives for localized depletion and user conflicts for the amendment and then approve the document for public hearing. The Council debated acceptable biological catch (ABC) control rule alternatives—the other major component of Amendment 8—during its September meeting. The Council also will approve 2019-2021 research priorities for the Atlantic Herring Research Set-Aside Program. Following these actions, the Council will adjourn for the day.

    Wednesday, December 6, 2017

    The second day of the meeting will begin with a report from the Northeast Fisheries Science Center on the results of the 2017 operational assessments for 19 of the 20 groundfish stocks managed under the Council's Northeast Multispecies FMP. The Scientific and Statistical Committee (SSC) will report next with overfishing limits (OFLs) and ABCs for the following stocks and fishing years (FY): Atlantic sea scallops for FY 2018 with defaults for FY 2019; northern and southern silver hake and red hake for FY 2018-2020; and all groundfish stocks for 2018-2020 except Georges Bank yellowtail flounder and Atlantic halibut. The Council then will begin its Groundfish Committee report, during which it will take final action on Framework Adjustment 57 to the Northeast Multispecies FMP. The framework includes: (1) 2018-2020 fishery specifications and other management measures; (2) 2018 TACs for U.S./Canada stocks of Eastern Georges Bank cod, Eastern Georges Bank haddock, and Georges Bank yellowtail flounder; (3) Atlantic halibut accountability measures (AMs); (4) recreational management measures; (5) common pool trimester TAC adjustments; (6) southern windowpane flounder AMs; and (7) potential consideration of a Georges Bank cod sub-annual catch limit for the recreational fishery. Also under groundfish, the Council may consider requesting emergency action to reduce catches of Georges Bank cod by implementing additional measures for the recreational fishery.

    Following a lunch break, members of the public will have the opportunity to speak during an open comment period on issues that relate to Council business but are not included on the published agenda for this meeting. The Council asks the public to limit remarks to 3-5 minutes. Then, the Groundfish Committee report will resume and continue until related business is concluded. The Council next will discuss its plan to provide input to NMFS on regulatory reform as mandated by Executive Orders 13777, 13771, and 13565. At the conclusion of this discussion, the Council will adjourn for the day.

    Thursday, December 7, 2017

    The third day of the meeting will begin with a discussion of and final action on 2018 Council priorities covering tasks and actions for all committees. Next, the Council will hear from its Scallop Committee and take final action on Framework Adjustment 29 to the Atlantic Sea Scallop FMP. This framework contains: (1) Fishery specifications for the 2018 fishing year and default specifications for 2019; (2) scallop fishery AMs for yellowtail flounder and windowpane flounder; (3) Northern Gulf of Maine Management Area modifications; and (4) measures to modify and/or create access area and open area boundaries consistent with potential changes to habitat and groundfish closed areas under the Council's Omnibus Essential Fish Habitat Amendment 2.

    Following a lunch break, the Scallop Committee discussion will continue until business is concluded. The Whiting Committee will report next. The Council will take final action on 2018-2020 specifications for small-mesh multispecies, which include red, silver, and offshore hakes, and then will deliberate Amendment 22 to the Northeast Multispecies FMP, which was developed to consider limiting access to the small-mesh multispecies fishery. The Council will: (1) Consider whether to pursue or drop consideration of triggered possession limit adjustments in the amendment; and (2) approve the draft amendment for public hearing. Next, the Council will take up spiny dogfish to review the previously set 2018 specifications for the fishery and discuss whether to recommend modifications. Finally, the Council will close out the meeting with “other business.”

    Although non-emergency issues not contained on this agenda may come before the Council for discussion, those issues may not be the subject of formal action during this meeting. Council 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 Fishery Conservation and Management Act, provided the public has been notified of the Council's intent to take final action to address the emergency. The public also should be aware that the meeting will be recorded. Consistent with 16 U.S.C. 1852, a copy of the recording is available upon request.

    Special Accommodations

    This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Thomas A. Nies (see ADDRESSES) at least 5 days prior to the meeting date.

    Dated: November 14, 2017. Tracey L. Thompson, Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2017-24961 Filed 11-16-17; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration Submission for OMB Review; Comment Request

    The Department of Commerce will submit to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. Chapter 35).

    Agency: National Oceanic and Atmospheric Administration (NOAA).

    Title: Scientific Research, Exempted Fishing, and Exempted Activity Submissions.

    OMB Control Number: 0648-0471.

    Form Number(s): None.

    Type of Request: Regular (extension of a currently approved information collection).

    Number of Respondents: 49.

    Average Hours per Response: 2 hours for a scientific research plan; 40 minutes for an application for an EFP, Display Permit, SRP, LOA, or Shark Research Permit; 1 hour for an interim report; 40 minutes for an annual fishing report; 15 minutes for an application for an amendment; 5 minutes for notification of departure phone calls to NMFS Enforcement; 10 minutes for calls to request and observer; and 2 minutes for “no-catch” reports.

    Burden Hours: 143.

    Needs and Uses: Exempted fishing permits (EFPs), scientific research permits (SRPs), display permits, letters of acknowledgment (LOAs), and shark research fishery permits are issued under the authority of the Magnuson-Stevens Fishery Conservation and Management Reauthorization Act (Magnuson-Stevens Act) (16 U.S.C. 1801 et seq.) and/or the Atlantic Tunas Convention Act (ATCA) (16 U.S.C. 971 et seq.). Issuance of EFPs and related permits is necessary for the collection of Highly Migratory Species (HMS) for public display and scientific research that requires exemption from regulations (e.g., seasons, prohibited species, authorized gear, and minimum sizes) that otherwise may prohibit such collection. Display permits are issued for the collection of HMS for the purpose of public display, and a limited number of shark research fishery permits are issued for the collection of fishery-dependent data for future stock assessments and cooperative research with commercial fishermen to meet the shark research objectives of the Agency.

    Affected Public: Business or other for-profit organizations; not-for-profit institutions; state, local or tribal government; federal government.

    Frequency: Annually and within 5 days of fishing.

    Respondent's Obligation: Required to obtain or retain benefits.

    This information collection request may be viewed at reginfo.gov. Follow the instructions to view Department of Commerce collections currently under review by OMB.

    Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to [email protected] or fax to (202) 395-5806.

    Dated: November 14, 2017. Sarah Brabson, NOAA PRA Clearance Officer.
    [FR Doc. 2017-24990 Filed 11-16-17; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XF819 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 Scallop 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 Thursday, November 30, 2017 at 9 a.m.

    ADDRESSES:

    The meeting will be held at the Hilton Garden Inn Logan Airport, 100 Boardman Street, Boston, MA 02128; Phone: (617) 567-6789.

    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 Scallop Committee will review Framework 29 (FW 29) alternatives and analyses, and make final recommendations. FW 29 will set specifications including acceptable biological catch/annual catch limit (ABC/ACLs), Days at Sea (DAS), access area allocations for Limited Access (LA) and Limited Access General Category (LAGC), Total Allowable Catch (TAC) for Northern Gulf of Maine (NGOM) management area, target-TAC for LAGC incidental catch and set-asides for the observer and research programs for fishing year 2018 and default specifications for fishing year 2019. Make final recommendations for potential FW 29 specifications that includes areas that may open through Omnibus Habitat Amendment 2 (OHA2). The committee will also review FW 29 management measures and make final recommendations. These measures may include, but are not limited to: (1) NGOM management measures; (2) Flatfish accountability measures for Northern windowpane flounder, Georges Bank yellowtail flounder, and Southern New England yellowtail flounder; (3) Measures to modify and/or create access area and open area boundaries, consistent with potential changes to habitat and groundfish closed areas; (4) measures to allocate unused CAI carryover pounds under certain scenarios of OHA2 approval. Other business may be discussed 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. 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. Consistent with 16 U.S.C. 1852, a copy of the recording is available upon request.

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: November 14, 2017. Tracey L. Thompson, Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2017-24957 Filed 11-16-17; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XF823 Caribbean Fishery Management Council; Public Meeting AGENCY:

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

    ACTION:

    Notice of a public meeting.

    SUMMARY:

    The Caribbean Fishery Management Council's (Council) Scientific and Statistical Committee (SSC) will hold a 5-day meeting in December to discuss the items contained in the agenda in the SUPPLEMENTARY INFORMATION.

    DATES:

    The meetings will be held from December 4 to December 8, 2017, from 9 a.m. to 5 p.m. These are new dates due to the passing of hurricanes Irma and Maria through Puerto Rico.

    ADDRESSES:

    The meetings will be held at the Council Office, 270 Muñoz Rivera Avenue, Suite 401, San Juan, Puerto Rico.

    FOR FURTHER INFORMATION CONTACT:

    Caribbean Fishery Management Council, 270 Muñoz Rivera Avenue, Suite 401, San Juan, Puerto Rico 00918-1903, telephone: (787) 766-5926.

    SUPPLEMENTARY INFORMATION:

    —Call to Order —Adoption of Agenda —Overview Review outcomes from previous meeting —Review Acceptable Biological Catch (ABC) Control Rule Language Review suggestions from General Counsel and Southeast Fisheries Science Center (SEFSC) on text of Tier 4 of the control rule Develop language to define “consensus” as used in determining Tier assignments (or otherwise alter language to remove the term) Action 2: Finalize establishment of stock/stock complexes for each of the Puerto Rico, St. Croix, St. Thomas/St. John Fishery Management Plans (FMPs) —Determine use of Indicator Species to recommend to the Council Finalize recommendations on: —Criteria used to select indicator species —How indicator species will be used to determine management reference points for stock complexes Action 3: Management Reference Points for Stocks/Stock complexes in each of the Puerto Rico, St. Thomas/St. John and St Croix FMPs Tiered ABC Control Rule: Review and finalize Tier assignments (4a or 4b): Puerto Rico, St. Croix, St. Thomas/St. John —Define process for determining the scalars used in Tiered ABC Control Rule —Define process for determining the buffer from the overfishing limit (OFL) to ABC (scientific uncertainty buffer) used in the Tiered ABC Control Rule. —Choice of scalar and scientific uncertainty buffer for Tiers 4a and 4b for the applicable stocks. Stocks/stock complexes to which the Tiered ABC CR cannot be applied: —Recommendations on time series of landings data (year sequences) to establish reference points for the applicable stocks/stock complexes. —Recommendations on the establishment of the maximum sustainable yield proxy (e.g., mean, median, following the Caribbean Annual Catch Limit Amendments' approach) for the applicable stocks/stock complexes. —Recommendations on the scientific uncertainty buffer to determine the ABC for the applicable stocks/stock complexes. —Recommendations to the Caribbean Fishery Management Council —Other Business

    The order of business may be adjusted as necessary to accommodate the completion of agenda items. The meeting will begin on December 4, 2017 at 9 a.m. Other than the start time, interested parties should be aware that discussions may start earlier or later than indicated. In addition, the meeting may be extended from, or completed prior to the date established in this notice.

    Special Accommodations

    These meetings are physically accessible to people with disabilities. For more information or request for sign language interpretation and other auxiliary aids, please contact Mr. Miguel A. Rolón, Executive Director, Caribbean Fishery Management Council, 270 Muñoz Rivera Avenue, Suite 401, San Juan, Puerto Rico 00918-1903, telephone: (787) 766-5926, at least 5 days prior to the meeting date.

    Dated: November 14, 2017. Tracey L. Thompson, Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2017-24958 Filed 11-16-17; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration Submission for OMB Review; Comment Request

    The Department of Commerce will submit to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. Chapter 35).

    Agency: National Oceanic and Atmospheric Administration (NOAA).

    Title: Economic Value of the Research in the Olympic Coast and Stellwagen Bank National Marine Sanctuaries.

    OMB Control Number: 0648-xxxx.

    Form Number(s): None.

    Type of Request: Regular (request for a new information collection).

    Number of Respondents: 106.

    Average Hours Per Response: 15 minutes.

    Burden Hours: 27.

    Needs and Uses: This request is for a new information collection.

    NOAA is conducting research to: (1) Identify if the sanctuary helps to attract research or creates value-added to researchers; (2) estimate the economic impacts (jobs, income, output) supported by research that occurs in sanctuaries because of expenditures occurring within local region. Two sites, Olympic Coast National Marine Sanctuary (OCNMS) and Stellwagen Bank National Marine Sanctuary (SBNMS) will be evaluated. The information will aide in SBNMS and OCNMS condition reports. Further, the research will help to provide baseline data for economic impact and contribution of sanctuaries to local area economies.

    The required information will involve surveys of researchers (from profit, non-profit and government agencies including local, state, federal and tribal). Information will be obtained on expenditures, sources of funds, non-market value, type of research, technologies used, use of NOAA equipment, reasons for the chosen location, and the researcher's involvement with sanctuary staff.

    ONMS will work to identify all researchers who worked within the sanctuary within the past ten years. This will be the population of interest. Sanctuary site staff, literature reviews and the research permit database will be used to identify the population of researchers for each site.

    Affected Public: Business or other for-profit; not-for-profit institutions; state, local or tribal government; federal government.

    Frequency: Annually.

    Respondent's Obligation: Voluntary.

    This information collection request may be viewed at reginfo.gov. Follow the instructions to view Department of Commerce collections currently under review by OMB.

    Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to [email protected] or fax to (202) 395-5806.

    Dated: November 14, 2017. Sarah Brabson, NOAA PRA Clearance Officer.
    [FR Doc. 2017-24989 Filed 11-16-17; 8:45 am] BILLING CODE 3510-NK-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XF840 North Pacific Fishery Management Council; Public Meeting AGENCY:

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

    ACTION:

    Notice of public meetings.

    SUMMARY:

    The North Pacific Fishery Management Council (Council) and its advisory committees will meet in December in Anchorage, AK.

    DATES:

    The Council will hold meetings from Monday, December 4 through Tuesday, December 12, 2017. See SUPPLEMENTARY INFORMATION for specific dates and times.

    ADDRESSES:

    The meeting will be held at the Anchorage Hilton Hotel, 500 W. 3rd Ave, Anchorage, AK 99501.

    Council address: North Pacific Fishery Management Council, 605 W. 4th Ave., Suite 306, Anchorage, AK 99501-2252; telephone: (907) 271-2809.

    FOR FURTHER INFORMATION CONTACT:

    Diana Evans, Council staff; telephone: (907) 271-2809.

    SUPPLEMENTARY INFORMATION:

    The Council will begin its plenary session at 8 a.m. in the Aleutian Room on Wednesday, December 6, continuing through Tuesday, December 12, 2017. The Scientific and Statistical Committee (SSC) will begin at 8 a.m. in the King Salmon/Iliamna Room on Monday, December 4 and continue through Wednesday, December 6, 2017. The Council's Advisory Panel (AP) will begin at 8 a.m. in the Dillingham/Katmai Room on Tuesday, December 5, and continue through Saturday, December 9, 2017. The Halibut Charter Management Committee will meet Monday, December 4, from 9 a.m. to 4 p.m. (Room TBD). The Legislative Committee will meet Tuesday, December 5, 2017, from 1 p.m. to 4 p.m. (Room TBD).

    Agenda Monday, December 4, 2017 Through Tuesday, December 12, 2017

    Council Plenary Session: The agenda for the Council's plenary session will include the following issues as well as an executive session. The Council may take appropriate action on any of the issues identified.

    (1) Executive Director's Report (2) Legislative Report (3) NMFS Management Report (including year-end inseason management report, Final 2018 Observer Annual Deployment Plan, Draft EM Policy Directive (T)) (4) NOAA GC report (including conflict of interest report (T)) (5) NOAA Enforcement Report (6) ADF&G Report (7) USCG Report (8) USFWS Report (9) Protected Species Report (including bowhead whale entanglement review) (10) IPHC Report (T) (11) 2018 Charter Halibut Management Measures (12) Charter Halibut Permits: Latent Capacity, RQE Ownership Caps (13) Self-guided Halibut Rental Boats (14) BSAI Groundfish Harvest Specifications—Final Specs (15) GOA Groundfish Harvest Specifications—Final Specs (16) Small Sideboards (17) Bering Sea Cod Trawl CV Participation (18) Western GOA Pcod A Season Halibut PSC Rates (19) Western GOA Pollock C/D Season Timing Chinook PSC (20) Western GOA Pollock Trip Limits (21) Stranded Cod in GOA Trawl B Season (22) Fixed Gear CV Rockfish Retention (23) Chinook Salmon Excluder EFP Consultation (24) Staff Tasking

    The Advisory Panel will address most of the same agenda issues as the Council.

    The SSC agenda will include the following issues:

    (1) BSAI Groundfish Harvest Specifications—Final Specifications (2) GOA Groundfish Harvest Specifications—Final Specifications (3) Small Sideboards (4) Chinook Salmon Excluder EFP

    In addition to providing ongoing scientific advice for fishery management decisions, the SSC functions as the Council's primary peer review panel for scientific information as described by the Magnuson-Stevens Act section 302(g)(1)(e), and the National Standard 2 guidelines (78 FR 43066). The peer review process is also deemed to satisfy the requirements of the Information Quality Act, including the OMB Peer Review Bulletin guidelines.

    The Agenda is subject to change, and the latest version will be posted at http://www.npfmc.org/.

    Although other non-emergency issues not on the agenda may come before this group for discussion, those issues may not be the subject of formal action during these meetings. Actions 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 Fishery Conservation and Management Act, provided the public has been notified of the Council's intent to take final action to address the emergency.

    Special Accommodations

    These meetings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Shannon Gleason at (907) 271-2809 at least 7 working days prior to the meeting date.

    Dated: November 14, 2017. Tracey L. Thompson, Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2017-24962 Filed 11-16-17; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XF825 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 Groundfish 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 Tuesday, November 28, 2017 at 9 a.m.

    ADDRESSES:

    The meeting will be held at the Courtyard Marriott Boston Logan Airport, 225 McClellan Highway, Boston, MA; phone: (617) 569-5250.

    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 Framework Adjustment 57/Specifications and Management Measures, review the draft alternatives under consideration, the Groundfish Plan Development Team's (PDT) impact analysis, and make recommendations on preferred alternatives to the Groundfish Committee. They will also disucss Amendment 23/Groundfish Monitoring and review an updated draft outline prepared by the PDT of the likely range of alternatives and make recommendations to the Committee. The Advisory Panel will also hold a discussion of possible groundfish priorities for 2018 and make recommendations to the Committee. They also plan to discuss several recent Executive Orders that have been issued about streamlining current regulations, and NOAA is seeking public input on the efficiency and effectiveness of current regulations and whether they can be improved. Discuss whether there are any regulations in the Northeast Multispecies fishery management plan that could be eliminated, improved, or streamlined. Other business will be discussed 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. 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. This meeting will be recorded. Consistent with 16 U.S.C. 1852, a copy of the recording is available upon request.

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: November 14, 2017. Tracey L. Thompson, Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2017-24959 Filed 11-16-17; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XF804 Mid-Atlantic Fishery Management Council (MAFMC); 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) Ecosystem and Ocean Planning Committee will hold a public meeting.

    DATES:

    The meeting will be held on Friday, December 1, 2017, from 10 a.m. to 4 p.m. For agenda details, see SUPPLEMENTARY INFORMATION.

    ADDRESSES:

    The meeting will be held at the Hilton Garden Inn BWI Airport, 1516 Aero Drive, Linthicum, MD 21090; telephone: (410)-691-0500.

    Council address: Mid-Atlantic Fishery Management Council, 800 N. State Street, Suite 201, Dover, DE 19901; telephone: (302) 674-2331 or on their Web site at 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 purpose of the meeting is to review and approve the EAFM based risk assessment for the Mid-Atlantic fishery resources which has been under development since early 2017. The Committee will review the final list of elements and the evaluation of risk posed by each element as recommended by Council staff. The Committee will make recommendations to the full Council for consideration at its December meeting in Annapolis, MD.

    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: November 14, 2017. Tracey L. Thompson, Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2017-24956 Filed 11-16-17; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XF801 Endangered Species; File Nos. 20590 and 20610 AGENCY:

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

    ACTION:

    Notice; receipt of applications.

    SUMMARY:

    Notice is hereby given that Nicole Phillips, Ph.D., The University of Southern Mississippi, Department of Biological Sciences, 118 College Drive #5018, Hattiesburg, MS 39406 (File No. 20590) and David Portnoy, Ph.D., Texas A&M University, Corpus Christi, TX 78412 (File No. 20610), have applied in due form for permits to receive and import sawfish and scalloped hammerhead shark samples for purposes of scientific research.

    DATES:

    Written, telefaxed, or email comments must be received on or before December 18, 2017.

    ADDRESSES:

    The application and related documents are available for review by selecting “Records Open for Public Comment” from the “Features” box on the Applications and Permits for Protected Species (APPS) home page, https://apps.nmfs.noaa.gov, and then selecting File Nos. 20590 or 20610 from the list of available applications.

    These documents are also available upon written request or by appointment in the Permits and Conservation Division, Office of Protected Resources, NMFS, 1315 East-West Highway, Room 13705, Silver Spring, MD 20910; phone (301) 427-8401; fax (301) 713-0376.

    Written comments on this application should be submitted to the Chief, Permits and Conservation Division, at the address listed above. Comments may also be submitted by facsimile to (301) 713-0376, or by email to [email protected] Please include the File No. in the subject line of the email comment.

    Those individuals requesting a public hearing should submit a written request to the Chief, Permits and Conservation Division at the address listed above. The request should set forth the specific reasons why a hearing on this application would be appropriate.

    FOR FURTHER INFORMATION CONTACT:

    Jennifer Skidmore (File Nos. 20590 or 20610), Malcolm Mohead (File No. 20590), or Erin Markin (File No. 20610), (301) 427-8401.

    SUPPLEMENTARY INFORMATION:

    The subject permit is requested under the authority of the Endangered Species Act of 1973, as amended (ESA; 16 U.S.C. 1531 et seq.) and the regulations governing the taking, importing, and exporting of endangered and threatened species (50 CFR parts 222-226).

    File No. 20590: The applicant (Dr. Phillips) is requesting authorization to import tissue samples from 5 species of listed sawfish including the smalltooth sawfish (Pristis pectinata), largetooth sawfish (P. pristis), green sawfish (P. zijsron), dwarf sawfish (P. clavata), and narrow sawfish (Anoxypristis cuspidate) to assess the impact of population decline through genetic diversity. This study will use tissue samples obtained opportunistically from saws with known location data held in museums, educational and private collections to: (1) Assess whether there has been a recent loss of genetic diversity in sawfishes globally, and (2) evaluate the long-term survival outlook for sawfishes. The applicant proposes to import tissue samples from up to a total of 500 sawfish specimens, from all species, annually from at least Mexico, Belize, United Arab Emirates, United Kingdom, and Australia to The University of Southern Mississippi for analysis. The requested duration of the permit is five years.

    File No. 20610: The applicant (Dr. Portnoy) is requesting authorization to import scalloped hammerhead (Sphyrna lewini) tissue in the form of fin clips or small muscle biopsies from Belize (Central & SW Atlantic DPS, up to 50 samples), Trinidad (Central & SW Atlantic DPS, up to 50 samples), Mexico (Eastern Pacific DPS, up to 100 samples; NW Atlantic & GOM DPS, up to 50 samples), Cuba (Central & SW Atlantic DPS, up to 50 samples), and Sierra Leone (Eastern Atlantic DPS, up to 50 samples) for genetic analysis at Texas A&M University in Corpus Christi. These samples would be used as part of a larger project to characterize the stock structure of S. lewini populations within the western Atlantic, as well as between the western Pacific and Atlantic, using next generation sequencing techniques. Tissue samples would be from animals that have been previously collected, or will be taken opportunistically as scalloped hammerheads are encountered in fish markets. The requested duration of the permit is five years.

    Dated: November 14, 2017. Julia Harrison, Chief, Permits and Conservation Division, Office of Protected Resources, National Marine Fisheries Service.
    [FR Doc. 2017-24946 Filed 11-16-17; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration Proposed Information Collection; Comment Request; Alaska Commercial Operator's Annual Report (COAR) AGENCY:

    National Oceanic and Atmospheric Administration (NOAA), Commerce.

    ACTION:

    Notice.

    SUMMARY:

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

    DATES:

    Written comments must be submitted on or before January 16, 2018.

    ADDRESSES:

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

    FOR FURTHER INFORMATION CONTACT:

    Requests for additional information or copies of the information collection instrument and instructions should be directed to Suja Hall, (907) 586-7462.

    SUPPLEMENTARY INFORMATION: I. Abstract

    This request is for extension of a currently approved information collection.

    The Alaska Commercial Operator's Annual Report (COAR) is a report that collects harvest and production information broken out by specific criteria such as gear type, area, delivery and product type, and pounds and value. The COAR is due by April 1 of the year following any buying or processing activity.

    Any person or company who received a Fisheries Business License from the Alaska Department of Revenue and an Intent to Operate Permit by Alaska Department of Fish and Game (ADF&G) is required to annually submit the COAR to the ADF&G, under Alaska Administrative Code (AAC), chapter 5 AAC 39.130. In addition, any person or company who receives an Exclusive Economic Zone (EEZ)-only permit from ADF&G annually must submit a COAR to ADF&G. Any owner of a catcher/processor or mothership with a Federal permit operating in the EEZ off Alaska is required to annually submit a COAR to ADF&G under 50 CFR 679.5(p).

    The COAR contains data on seafood purchasing, production, ex-vessel values, and first wholesale values for seafood products. Containing information from shoreside processors, stationary floating processors, motherships, and catcher/processors, this data collection yields equivalent annual product value information for all respective processing sectors and provides a consistent time series according to which groundfish resources may be managed more efficiently. Use of the information generated by the COAR is coordinated between NMFS and the ADF&G.

    II. Method of Collection

    The COAR is available in pdf and Microsoft Word formats on the ADF&G Web site at http://www.adfg.alaska.gov/index.cfm?adfg=fishlicense.coar. Respondents complete either a paper form or the fillable file available online and submit the form by mail to the ADF&G.

    III. Data

    OMB Control Number: 0648-0428.

    Form Number(s): None.

    Type of Review: Regular submission (extension of a current information collection).

    Affected Public: Business or other for-profit organizations.

    Estimated Number of Respondents: 179.

    Estimated Time per Response: 8 hr.

    Estimated Total Annual Burden Hours: 1,432.

    Estimated Total Annual Cost to Public: $716 in recordkeeping/reporting costs.

    IV. Request for Comments

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

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

    Dated: November 14, 2017. Sarah Brabson, NOAA PRA Clearance Officer.
    [FR Doc. 2017-24991 Filed 11-16-17; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF EDUCATION [Docket No.: ED-2017-ICCD-0116] Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Gainful Employment Programs—Subpart Q AGENCY:

    Federal Student Aid (FSA), Department of Education (ED).

    ACTION:

    Notice.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995, ED is proposing a revision of an existing information collection.

    DATES:

    Interested persons are invited to submit comments on or before December 18, 2017.

    ADDRESSES:

    To access and review all the documents related to the information collection listed in this notice, please use http://www.regulations.gov by searching the Docket ID number ED-2017-ICCD-0116. Comments submitted in response to this notice should be submitted electronically through the Federal eRulemaking Portal at http://www.regulations.gov by selecting the Docket ID number or via postal mail, commercial delivery, or hand delivery. Please note that comments submitted by fax or email and those submitted after the comment period will not be accepted. Written requests for information or comments submitted by postal mail or delivery should be addressed to the Director of the Information Collection Clearance Division, U.S. Department of Education, 400 Maryland Avenue SW., LBJ, Room 216-34, Washington, DC 20202-4537.

    FOR FURTHER INFORMATION CONTACT:

    For specific questions related to collection activities, please contact Beth Grebeldinger, 202-377-4018.

    SUPPLEMENTARY INFORMATION:

    The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.

    Title of Collection: Gainful Employment Programs—Subpart Q.

    OMB Control Number: 1845-0123.

    Type of Review: A revision of an existing information collection.

    Respondents/Affected Public: Private Sector; Individuals or Households; State, Local, and Tribal Governments.

    Total Estimated Number of Annual Responses: 42,303,576.

    Total Estimated Number of Annual Burden Hours: 3,777,952.

    Abstract: The Student Assistance General Provisions regulations were amended by adding Subpart Q to Part 668, to establish measures for determining whether certain postsecondary educational programs lead to gainful employment in recognized occupations, and the conditions under which these educational programs remain eligible for student financial assistance programs authorized under Title IV of the Higher Education Act of 1965, as amended (HEA).

    On June 16, 2017, the Department of Education (the Department) published a notice in the Federal Register announcing the intention to establish a negotiated rulemaking committee to revise the gainful employment regulations published on October 31, 2014. The Department anticipates scheduling the negotiated rulemaking sessions beginning in November or December 2017. There have been no changes to the regulations since the October 31, 2014 regulatory approval.

    This clearance package includes §§ 668.405, 668.410, 668.411, 668.413, and 668.414. The burden related to § 668.412 was removed from this collection and applied to information collection 1845-0107 in February 2017 to more accurately associate the requirements of the regulations with the correct collection package.

    Dated: November 14, 2017 Kate Mullan, Acting Director, Information Collection Clearance Division, Office of the Chief Privacy Officer, Office of Management.
    [FR Doc. 2017-24976 Filed 11-16-17; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF EDUCATION [Docket No.: ED-2017-ICCD-0117] Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Gainful Employment Program—Subpart Q—Appeals for Debt to Earnings Rates AGENCY:

    Federal Student Aid (FSA), Department of Education (ED).

    ACTION:

    Notice.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995, ED is proposing an extension of an existing information collection.

    DATES:

    Interested persons are invited to submit comments on or before December 18, 2017.

    ADDRESSES:

    To access and review all the documents related to the information collection listed in this notice, please use http://www.regulations.gov by searching the Docket ID number ED-2017-ICCD-0117. Comments submitted in response to this notice should be submitted electronically through the Federal eRulemaking Portal at http://www.regulations.gov by selecting the Docket ID number or via postal mail, commercial delivery, or hand delivery. Please note that comments submitted by fax or email and those submitted after the comment period will not be accepted. Written requests for information or comments submitted by postal mail or delivery should be addressed to the Director of the Information Collection Clearance Division, U.S. Department of Education, 400 Maryland Avenue SW., LBJ, Room 216-34, Washington, DC 20202-4537.

    FOR FURTHER INFORMATION CONTACT:

    For specific questions related to collection activities, please contact Beth Grebeldinger, 202-377-4018.

    SUPPLEMENTARY INFORMATION:

    The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.

    Title of Collection: Gainful Employment Program—Subpart Q—Appeals for Debt to Earnings Rates.

    OMB Control Number: 1845-0122.

    Type of Review: An extension of an existing information collection.

    Respondents/Affected Public: Private Sector; State, Local, and Tribal Governments.

    Total Estimated Number of Annual Responses: 792.

    Total Estimated Number of Annual Burden Hours: 23,860.

    Abstract: The Student Assistance General Provisions regulation was amended by adding Subpart Q to Part 668. This subpart applies to postsecondary educational programs that lead to gainful employment (GE) in recognized occupations. 1845-0122 pertains to § 668.406—Appeals for Debt to Earnings (D/E) rates. The regulations allow an institution to submit alternate earnings appeals to challenge the Secretary's determination of a GE program that is failing or in the zone based on the D/E rates calculated for a specific GE program.

    On June 16, 2017, the Department of Education (the Department) published a notice in the Federal Register announcing the intention to establish a negotiated rulemaking committee to revise the gainful employment regulations published on October 31, 2014. The Department anticipates scheduling the negotiated rulemaking sessions beginning in November or December 2017.

    The Department is requesting an extension without change of burden to the currently approved information collection as any new regulations will not be available before the expiration of this current package. There have been no changes to the regulations since the initial approval of the information collection on November 3, 2014.

    Dated: November 14, 2017. Kate Mullan, Acting Director, Information Collection Clearance Division, Office of the Chief Privacy Officer, Office of Management.
    [FR Doc. 2017-24977 Filed 11-16-17; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF EDUCATION [Docket No.: ED-2017-ICCD-0118] Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Gainful Employment Program—Subpart R—Cohort Default Rates AGENCY:

    Federal Student Aid (FSA), Department of Education (ED).

    ACTION:

    Notice.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995, ED is proposing an extension of an existing information collection.

    DATES:

    Interested persons are invited to submit comments on or before December 18, 2017.

    ADDRESSES:

    To access and review all the documents related to the information collection listed in this notice, please use http://www.regulations.gov by searching the Docket ID number ED-2017-ICCD-0118. Comments submitted in response to this notice should be submitted electronically through the Federal eRulemaking Portal at http://www.regulations.gov by selecting the Docket ID number or via postal mail, commercial delivery, or hand delivery. Please note that comments submitted by fax or email and those submitted after the comment period will not be accepted. Written requests for information or comments submitted by postal mail or delivery should be addressed to the Director of the Information Collection Clearance Division, U.S. Department of Education, 400 Maryland Avenue SW., LBJ, Room 216-34, Washington, DC 20202-4537.

    FOR FURTHER INFORMATION CONTACT:

    For specific questions related to collection activities, please contact Beth Grebeldinger, 202-377-4018.

    SUPPLEMENTARY INFORMATION:

    The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.

    Title of Collection: Gainful Employment Program—Subpart R—Cohort Default Rates.

    OMB Control Number: 1845-0121.

    Type of Review: An extension of an existing information collection.

    Respondents/Affected Public: Private Sector; State, Local, and Tribal Governments.

    Total Estimated Number of Annual Responses: 1,559.

    Total Estimated Number of Annual Burden Hours: 5,656.

    Abstract: The Student Assistance General Provisions regulation was amended by adding Subpart R to 34 CFR part 668. Subpart R—Program Cohort Default Rates mirrors Subpart N—Cohort Default Rates where applicable. Subpart R established a programmatic cohort default rate (pCDR) for gainful employment (GE) programs, whereas Subpart N established an institutional cohort default rate (iCDR).

    On June 16, 2017, the Department of Education (the Department) published a notice in the Federal Register announcing the intention to establish a negotiated rulemaking committee to revise the gainful employment regulations published on October 31, 2014. The Department anticipates scheduling the negotiated rulemaking sessions beginning in November or December 2017.

    The Department is requesting an extension without change of burden to the currently approved information collection as any new regulations will not be finalized before the expiration of this current package. There have been no changes to the regulations since the initial collection approval.

    Dated: November 14, 2017. Kate Mullan, Acting Director, Information Collection Clearance Division, Office of the Chief Privacy Officer, Office of Management.
    [FR Doc. 2017-24978 Filed 11-16-17; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF EDUCATION [Docket No.: ED-2017-ICCD-0140] Agency Information Collection Activities; Comment Request; Freedom of Information Act (FOIA) Third Party Perjury Form AGENCY:

    Office of Management (OM), Department of Education (ED).

    ACTION:

    Notice.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995, ED is proposing an extension of an existing information collection.

    DATES:

    Interested persons are invited to submit comments on or before January 16, 2018.

    ADDRESSES:

    To access and review all the documents related to the information collection listed in this notice, please use http://www.regulations.gov by searching the Docket ID number ED-2017-ICCD-0140. Comments submitted in response to this notice should be submitted electronically through the Federal eRulemaking Portal at http://www.regulations.gov by selecting the Docket ID number or via postal mail, commercial delivery, or hand delivery. Please note that comments submitted by fax or email and those submitted after the comment period will not be accepted. Written requests for information or comments submitted by postal mail or delivery should be addressed to the Director of the Information Collection Clearance Division, U.S. Department of Education, 400 Maryland Avenue SW., LBJ, Room 216-32, Washington, DC 20202-4537.

    FOR FURTHER INFORMATION CONTACT:

    For specific questions related to collection activities, please contact Elise Cook, 202-401-3769.

    SUPPLEMENTARY INFORMATION:

    The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.

    Title of Collection: Freedom of Information Act (FOIA) Third Party Perjury Form.

    OMB Control Number: 1880-0545.

    Type of Review: An extension of an existing information collection.

    Respondents/Affected Public: Individuals or Households.

    Total Estimated Number of Annual Responses: 62,000.

    Total Estimated Number of Annual Burden Hours: 31,000.

    Abstract: This collection is necessary to certify the identity of individuals requesting information under the Freedom of Information Act (FOIA) and Privacy Act (PA). This certification is required under 5 U.S.C. Section 552a(b). The form is used by Privacy Act requesters to obtain personal records via regular mail, fax or email. The department will use the information to help identify first-party or third party requesters with same or similar name when requesting retrieval of their own documents.

    Dated: November 14, 2017 Stephanie Valentine, Acting Director, Information Collection Clearance Division, Office of the Chief Privacy Officer, Office of Management.
    [FR Doc. 2017-24941 Filed 11-16-17; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Combined Notice of Filings

    Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:

    Filings Instituting Proceedings

    Docket Numbers: RP18-147-000.

    Applicants: Gulf South Pipeline Company, LP.

    Description: § 4(d) Rate Filing: Remove Expired and Expiring Agmts from Tariff to be effective 11/7/2017.

    Filed Date: 11/7/17.

    Accession Number: 20171107-5021.

    Comments Due: 5 p.m. ET 11/20/17.

    Docket Numbers: RP17-1138-001.

    Applicants: Texas Gas Transmission, LLC.

    Description: Compliance Filing: Compliance Filing in Docket No. RP17-1138-000 to be effective 11/1/2017.

    Filed Date: 11/6/17.

    Accession Number: 20171106-5212.

    Comments Due: 5 p.m. ET 11/20/17.

    The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.

    Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.

    eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: November 7, 2017. Nathaniel J. Davis, Sr. Deputy Secretary.
    [FR Doc. 2017-24988 Filed 11-16-17; 8:45 am] BILLING CODE 6717-01-P
    ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OAR-2007-0482-0012; FRL—9969-76-OEI] Information Collection Request Submitted to OMB for Review and Approval; Comment Request; SmartWay Transport Partnership (Renewal) AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice.

    SUMMARY:

    The Environmental Protection Agency has submitted an information collection request (ICR), “SmartWay Transport Partnership” (EPA ICR No. 2265.03, OMB Control No. 2060-0663) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a reinstatement of the ICR, which was currently approved through July 31, 2017. Public comments were previously requested via the Federal Register on July 7, 2017 during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

    DATES:

    Additional comments may be submitted on or before December 18, 2017.

    ADDRESSES:

    Submit your comments, referencing Docket ID Number EPA-HQ-OAR-2007-0482-0012 to (1) EPA online using www.regulations.gov (our preferred method), by email to [email protected], or by mail to: EPA Docket Center, Environmental Protection Agency, Mail Code 28221T, 1200 Pennsylvania Ave. NW., Washington, DC 20460, and (2) OMB via email to [email protected] Address comments to OMB Desk Officer for EPA.

    EPA's policy is that all comments received will be included in the public docket without change including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.

    FOR FURTHER INFORMATION CONTACT:

    Kathleen Martz, U.S. Environmental Protection Agency, 2000 Traverwood Drive, S-68, Ann Arbor, MI 48105; telephone number: 734-214-4335; Fax: 734-214-4906; email address: [email protected]

    SUPPLEMENTARY INFORMATION:

    Supporting documents, which explain in detail the information that the EPA will be collecting, are available in the public docket for this ICR. The docket can be viewed online at www.regulations.gov or in person at the EPA Docket Center, WJC West, Room 3334, 1301 Constitution Ave. NW., Washington, DC. The telephone number for the Docket Center is 202-566-1744. For additional information about EPA's public docket, visit http://www.epa.gov/dockets.

    Abstract: SmartWay is a voluntary program that focuses on increasing efficiency and lowering air pollution generated by goods movement that is open to organizations that own, operate, or contract with fleet operations, including truck, rail, barge, air and multi-modal carriers, logistics companies, and shippers. Organizations that do not operate fleets, but that are working to strengthen the freight industry, such as industry trade associations, state and local transportation agencies and environmental groups, also may join as SmartWay affiliates. All organizations that join SmartWay are asked to provide EPA with information as part of their SmartWay registration to annually benchmark their transportation-related operations and improve the environmental performance of their freight activities.

    A company joins SmartWay when it completes and submits a SmartWay Excel-based tool (“reporting tool”) to EPA. The data outputs from the submitted tool are used by partners and SmartWay in several ways. First, the data provides confirmation that SmartWay partners are meeting established objectives in their Partnership Agreement. The reporting tool outputs enable EPA to assist SmartWay partners as appropriate, and to update them with environmental performance and technology information that empower them to improve their efficiency. This information also improves EPA's knowledge and understanding of the environmental and energy impacts associated with goods movement, and the effectiveness of both proven and emerging strategies to lessen those impacts.

    In addition to requesting annual freight transportation-related data, EPA may ask its SmartWay partners for other kinds of information which could include opinions and test data on the effectiveness of new and emerging technology applications, sales volumes associated with SmartWay-recommended vehicle equipment and technologies, the reach and value of partnering with EPA through the SmartWay Partnership, and awareness of the SmartWay brand. In some instances, EPA might query other freight industry representatives (not just SmartWay partners), including trade and professional associations, nonprofit environmental groups, energy and community organizations, and universities, and a small sampling of the general public.

    Form Numbers: None.

    Respondents/affected entities: Private and public organizations that join SmartWay Transport Partnership; freight industry representatives who engage in activities related to the SmartWay Partnership; and representative samplings of consumers in the general public.

    Respondent's obligation to respond: Voluntary.

    Estimated number of respondents: 4,605.

    Frequency of response: Once, on occasion and annually.

    Total estimated burden: 13,224 hours.

    Total estimated cost: $909,828, which includes no capital or operation and maintenance costs.

    Changes in the Estimates: There is an increase of 1,720 hours in the total estimated respondent partner burden compared with the ICR currently approved by OMB. This increase reflects the following adjustments and program changes:

    (1) Adjustments increase associated with increased interest in SmartWay, and thus, an increase in new annual respondents, as well as robust program retention practices, leading to increased number of existing respondent partners reporting annually, increase in the number of applications for the SmartWay Excellence Awards and the affiliate challenge annually;

    (2) Program change increase associated with the new SmartWay Affiliate Program and new requirements under SmartWay Tractor and Trailer program; and,

    (3) Adjustment decrease due to EPA's change in policy for submitting Awards materials electronically, rather than by mail.

    Courtney Kerwin, Acting Director, Collection Strategies Division.
    [FR Doc. 2017-24971 Filed 11-16-17; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [EPA-R09-OAR-2017-0507; FRL-9970-42-Region 9] Adequacy Status of Motor Vehicle Emissions Budgets in Submitted Reasonable Further Progress Plan for San Diego 8-Hour Ozone for Transportation Conformity Purposes; California AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice of adequacy.

    SUMMARY:

    The Environmental Protection Agency (EPA or “Agency”) is notifying the public that the Agency has found that the motor vehicle emissions budgets (“budgets”) for the Reasonable Further Progress (RFP) milestone year 2017 from the “2008 Eight-Hour Ozone Attainment Plan for San Diego County (December 2016)” (“2016 San Diego Ozone Plan” or “plan”), are adequate for transportation conformity purposes for the 2008 ozone national ambient air quality standards (NAAQS). The California Air Resources Board (CARB) submitted the 2016 San Diego Ozone Plan to the EPA on April 12, 2017, as a revision to the California State Implementation Plan (SIP). Upon the effective date of this notice of adequacy, the previously-approved budgets for the 1997 8-hour ozone standards will no longer be applicable for transportation conformity purposes, and the San Diego Association of Governments (SANDAG) and the U.S. Department of Transportation must use these adequate budgets in future transportation conformity determinations.

    DATES:

    This finding is effective December 4, 2017.

    FOR FURTHER INFORMATION CONTACT:

    John Kelly, EPA, Region IX, Air Division AIR-2, 75 Hawthorne Street, San Francisco, CA 94105-3901; (415) 947-4151 or [email protected]

    SUPPLEMENTARY INFORMATION:

    Throughout this document, whenever “we,” “us,” or “our” is used, we mean the EPA.

    Today's notice is simply an announcement of a finding that we have already made. The EPA sent a letter to CARB on October 19, 2017 stating that the motor vehicle emissions budgets in the submitted 2016 San Diego Ozone Plan for the RFP milestone year 2017 are adequate for transportation conformity purposes.1 We announced availability of the plan and related budgets on the EPA's transportation conformity Web site on July 20, 2017, requesting comments by August 21, 2017. We received no comments in response to the adequacy review posting. The finding is available at the EPA's conformity Web site: https://www.epa.gov/state-and-local-transportation/state-implementation-plans-sip-submissions-epa-has-found-adequate-or. The adequate motor vehicle emissions budgets are provided in the following table:

    1See letter from Matthew J. Lakin, Acting Director, Air Division, EPA Region IX, to Richard Corey, Executive Officer, CARB, dated October 19, 2017.

    Adequate Motor Vehicle Emissions Budgets Budget year Volatile
  • organic
  • compounds
  • (tons per
  • summer day)
  • Nitrogen
  • oxides
  • (tons per
  • summer day)
  • 2017 23 42

    Transportation conformity is required by Clean Air Act section 176(c). The EPA's conformity rule requires that transportation plans, transportation improvement programs, and transportation projects conform to a state's air quality SIP and establishes the criteria and procedures for determining whether or not they conform. Conformity to a SIP means that transportation activities will not produce new air quality violations, worsen existing violations, or delay timely attainment of the NAAQS.

    The criteria we use to determine whether a SIP's motor vehicle emission budgets are adequate for conformity purposes are outlined in 40 CFR 93.118(e)(4), promulgated on August 15, 1997.2 We have further described our process for determining the adequacy of submitted SIP budgets in our final rule dated July 1, 2004, and we used the information in these resources in making our adequacy determination.3 Please note that an adequacy review is separate from the EPA's completeness review and should not be used to prejudge the EPA's ultimate action on the SIP. Even if we find a budget adequate, the SIP could later be disapproved.

    2See 62 FR 43780 (August 15, 1997).

    3See 69 FR 40004 (July 1, 2004).

    Pursuant to 40 CFR 93.104(e), within 2 years of the effective date of this notice, SANDAG and the U.S. Department of Transportation will need to demonstrate conformity to the new budgets if the demonstration has not already been made.4 For demonstrating conformity to the budgets in this plan, the on-road motor vehicle emissions from implementation of the transportation plan or program should be projected consistently with the budgets in this plan, i.e., by taking the county's emissions results derived from CARB's EMFAC model (short for EMission FACtor) and then rounding the emissions up to the nearest ton.

    4See 73 FR 4419 (January 24, 2008).

    Authority:

    42 U.S.C. 7401 et seq.

    Dated: October 25, 2017. Alexis Strauss, Acting Regional Administrator, Region IX.
    [FR Doc. 2017-25020 Filed 11-16-17; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [ER-FRL-9036-2)] Environmental Impact Statements; Notice of Availability

    Responsible Agency: Office of Federal Activities, General Information (202) 564-7146 or http://www2.epa.gov/nepa/.

    Weekly receipt of Environmental Impact Statements (EISs) Filed 11/06/2017 Through 11/10/2017 Pursuant to 40 CFR 1506.9. Notice

    Section 309(a) of the Clean Air Act requires that EPA make public its comments on EISs issued by other Federal agencies. EPA's comment letters on EISs are available at: https://cdxnodengn.epa.gov/cdx-nepa-public/action/eis/search.

    EIS No. 20170219, Draft Supplement, FRA, CA, California High-Speed Rail: Fresno to Bakersfield Section, Comment Period Ends: 01/16/2018, Contact: Stephanie Perez (202) 493-0388. EIS No. 20170222, Final, NMFS, OR, Analyze Impacts of NOAA's National Marine Fisheries, Service joining as a signatory to a new U.S. v. Oregon, Management Agreement for the Years 2018-2027, Review Period Ends: 12/18/2017, Contact: Jeromy Jording (360) 753-9576. EIS No. 20170223, Draft, NCPC, DC, South Mall Campus Master Plan, Comment Period Ends: 01/16/2018, Contact: Matthew Flis (202) 482-7236. EIS No. 20170224, Draft, USACE, VA, Draft Integrated City of Norfolk Coastal Storm Risk Management Feasibility Study, Comment Period Ends: 01/02/2018, Contact: Kathy Perdue (757) 201-7218. EIS No. 20170225, Final, DOS, DC, Foreign Missions Center at the Former Walter Reed Army Medical Center, Review Period Ends: 12/18/2017, Contact: Geoffrey Hunt (202) 647-7530. EIS No. 20170226, Draft Supplement, BLM, AZ, Ray Land Exchange Plan Amendment, Comment Period Ends: 02/16/2018, Contact: Michael Werner (602) 417-9561. EIS No. 20170227, Draft, TVA, TN, Cumberland Fossil Plant Coal Combustion Residual Management Operations, Comment Period Ends: 01/02/2018, Contact: Anita Masters (423) 751-8697. EIS No. 20170228, Final, FHWA, NY, New York State Route 198 (Scajaquada Expressway) Corridor Project, Review Period Ends: 12/19/2017, Contact: Peter Osborn (518) 431-4127. Dated: November 14, 2017. Kelly Knight, Director, NEPA Compliance Division, Office of Federal Activities.
    [FR Doc. 2017-24973 Filed 11-16-17; 8:45 am] BILLING CODE 6560-50-P
    EQUAL EMPLOYMENT OPPORTUNITY COMMISSION Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery AGENCY:

    Equal Employment Opportunity Commission.

    ACTION:

    Notice and request for comments.

    SUMMARY:

    As part of a Federal Government-wide effort to streamline the process to seek feedback from the public on service delivery, the U.S. Equal Employment Opportunity Commission (EEOC) has submitted a Generic Information Collection Request (Generic ICR): “Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery” to OMB for approval under the Paperwork Reduction Act (PRA).

    DATES:

    Written comments on this notice must be submitted on or before December 18, 2017.

    ADDRESSES:

    Comments on this notice must be submitted to Joseph B. Nye, Policy Analyst, Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street NW., Washington, DC 20503, email [email protected] Commenters are also encouraged to send comments to the EEOC online at http://www.regulations.gov, which is the Federal eRulemaking Portal. Follow the instructions on this Web site for submitting comments. In addition, the EEOC's Executive Secretariat will accept comments in hard copy. Hard copy comments should be sent to Bernadette Wilson, Acting Executive Officer, EEOC, 131 M Street NE., Washington, DC 20507. Finally, the Executive Secretariat will accept comments totaling six or fewer pages by facsimile (“fax”) machine before the same deadline at (202) 663-4114. (This is not a toll-free number.) Receipt of fax transmittals will not be acknowledged, except that the sender may request confirmation of receipt by calling the Executive Secretariat staff at (202) 663-4070 (voice) or (202) 663-4074 (TTY). (These are not toll-free telephone numbers.) The EEOC will post online at http://www.regulations.gov all comments submitted, regardless of whether they are submitted via the Web site, in hard copy, or by fax to the Executive Secretariat. These comments will be posted without change, including any personal information you provide. However, the EEOC reserves the right to refrain from posting libelous or otherwise inappropriate comments including those that contain obscene, indecent, or profane language; that contain threats or defamatory statements; that contain hate speech directed at race, color, sex, national origin, age, religion, disability, or genetic information; or that promote or endorse services or products. All comments received, including any personal information provided, also will be available for public inspection during normal business hours by appointment only at the EEOC Headquarters Library, 131 M Street NE., Washington, DC 20507. Upon request, individuals who require assistance viewing comments will be provided appropriate aids such as readers or print magnifiers. To schedule an appointment, contact EEOC Library staff at (202) 663-4630 (voice) or (202) 663-4641 (TTY). (These are not toll-free numbers.)

    FOR FURTHER INFORMATION CONTACT:

    Erin Norris, Senior Attorney, EEOC Office of Legal Counsel, 129 W. Trade Street, Charlotte, NC 28202, 704-954-6491, [email protected]

    SUPPLEMENTARY INFORMATION:

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

    Abstract: The information collection activity will garner qualitative customer and stakeholder feedback in an efficient, timely manner, in accordance with the government's commitment to improving 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.

    Feedback collected under this generic clearance will provide useful information, but it will 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 non-response bias, the protocols for data collection, and any testing procedures that were or will be undertaken prior 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.

    No comments were received by the agency in response to the 60-day notice published in the Federal Register of December 22, 2010 (75 FR 80542).

    Below we provide EEOC's projected average estimates for the next three years:

    Current Actions: New collection of information.

    Type of Review: New collection.

    Affected Public: Individuals and households, businesses and organizations, State, Local or Tribal Government.

    Average Expected Annual Number of Activities: 5.

    Respondents: 8,020.

    Annual Responses: 11,020.

    Frequency of Response: Once per respondent for four activities, twice per respondent for one activity.

    Average Minutes per Response: 6.5.

    Burden Hours: 1194.

    An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid Office of Management and Budget control number.

    For the Commission.

    Dated: November 9, 2017. Victoria A. Lipnic, Acting Chair.
    [FR Doc. 2017-24979 Filed 11-16-17; 8:45 am] BILLING CODE 6570-01-P
    FEDERAL MARITIME COMMISSION [Petition No. P2-17] Petition of COSCO Shipping Lines Co., Ltd., Orient Overseas Container Line Limited, and OOCL (Europe) Limited for an Exemption From Agreement Filing; Notice of Filing And Request for Comments

    Notice is hereby given that COSCO Shipping Lines Co., Ltd., Orient Overseas Container Line Limited, and OOCL (Europe) Limited (“Petitioners”), have petitioned the Commission pursuant to Section 16 of the Shipping Act of 1984, 46 U.S.C. 40103(a), 46 CFR 502.92, and 46 CFR 535.301, for an exemption from agreement filing requirements Petitioners request an exemption “to replicate as to Cosco and OOCL the exemption automatically applicable to wholly-owned subsidiaries pursuant to 46 CFR 535.307, including its exemption from the provisions of Section 10(c) of the Act, 46 U.S.C. 41105.”

    The Petitioners state that a pending business transaction will make them “. . . part of a single, common business enterprise . . .” though they will retain the brands as separate legal entities. The Petitioners speculate that “the transaction will be completed . . . potentially as early as mid-December 2017.” Petitioners state that “the exemption would apply to all agreements and activities between Cosco and OOCL that would otherwise be subject to filing under the Act, so long as the parties are commonly owned and controlled.” The Petitioners claim that “the requested exemption will not result in a substantial reduction in competition and will not be detrimental to commerce.”

    In order for the Commission to make a thorough evaluation of the exemption requested in the Petition, pursuant to 46 CFR 502.92, interested parties are requested to submit views or arguments in reply to the Petition no later than December 1, 2017. Replies shall be sent to the Secretary by email to [email protected] or by mail to Federal Maritime Commission, 800 North Capitol Street NW., Washington, DC 20573-0001, and replies shall be served on Petitioners' counsels, David F. Smith, Cozen O' Connor, 1200 Nineteenth Street NW., Suite 300, Washington, DC 20036, [email protected], Robert B. Yoshitomi, Nixon Peabody LLP, 300 South Grand Avenue, Suite 4100, Los Angeles, CA 90071-3151, [email protected], and Eric C. Jeffrey, 799 9th Street NW., Suite 500, Washington, DC 20001-5327, [email protected]

    Non-confidential filings may be submitted in hard copy to the Secretary at the above address or by email as a PDF attachment to [email protected] and include in the subject line: P2-17 (Commenter/Company). Confidential filings should not be filed by email. A confidential filing must be filed with the Secretary in hard copy only, and be accompanied by a transmittal letter that identifies the filing as “Confidential-Restricted” and describes the nature and extent of the confidential treatment requested. The Commission will provide confidential treatment to the extent allowed by law for confidential submissions, or parts of submissions, for which confidentiality has been requested. When a confidential filing is submitted, there must also be submitted a public version of the filing. Such public filing version shall exclude confidential materials, and shall indicate on the cover page and on each affected page “Confidential materials excluded.” Public versions of confidential filings may be submitted by email. The Petition will be posted on the Commission's Web site at http://www.fmc.gov/P2-17. Replies filed in response to the Petition will also be posted on the Commission's Web site at this location.

    Rachel E. Dickon, Assistant Secretary.
    [FR Doc. 2017-25007 Filed 11-16-17; 8:45 am] BILLING CODE 6731-AA-P
    FEDERAL TRADE COMMISSION Agency Information Collection Activities; Submission for OMB Review; Comment Request AGENCY:

    Federal Trade Commission (“FTC” or “Commission”).

    ACTION:

    Notice.

    SUMMARY:

    The information collection requirements described below will be submitted to the Office of Management and Budget (“OMB”) for review, as required by the Paperwork Reduction Act (“PRA”). The FTC seeks public comments on proposed information requests sent pursuant to compulsory process to a combined ten or more of the largest domestic cigarette manufacturers and smokeless tobacco manufacturers. The information sought would include, among other things, data on annual sales and marketing expenditures. The current FTC clearance from the Office of Management and Budget (“OMB”) to conduct such information collection expires January 31, 2018. The Commission intends to ask OMB for renewed three-year clearance to collect this information.

    DATES:

    Comments on the proposed information requests must be received on or before December 18, 2017.

    ADDRESSES:

    Interested parties may file a comment online or on paper, by following the instructions in the Request for Comment part of the SUPPLEMENTARY INFORMATION section below. Write: “Tobacco Reports: Paperwork Comment, FTC File No. P054507” on your comment, and file the comment online at https://ftcpublic.commentworks.com/ftc/tobaccoreportspra by following the instructions on the web-based form. If you prefer to file your comment on paper, mail your comment to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW., Suite CC-5610 (Annex J), Washington, DC 20580, or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW., 5th Floor, Suite 5610 (Annex J), Washington, DC 20024.

    FOR FURTHER INFORMATION CONTACT:

    Requests for additional information or copies of the proposed collection of information should be addressed to Michael Ostheimer, Division of Advertising Practices, Bureau of Consumer Protection, Federal Trade Commission, 600 Pennsylvania Avenue NW., Mailstop CC-10603, Washington, DC 20580. Telephone: (202) 326-2699.

    SUPPLEMENTARY INFORMATION:

    Title: FTC Cigarette and Smokeless Tobacco Data Collection.

    OMB Control Number: 3084-0134.

    Type of Review: Extension of currently approved collection.

    On August 10, 2017, the Commission sought comment on the information collection requirements associated with the Cigarette and Smokeless Tobacco Data Collection. 82 FR 37440 (“August 10, 2017 Notice”). Pursuant to the OMB regulations, 5 CFR part 1320, that implement the PRA, 44 U.S.C. 3501 et seq., the FTC is providing a second opportunity for the public to comment while seeking OMB approval to renew the existing clearance for the information the FTC proposes to seek from the largest domestic cigarette manufacturers and smokeless tobacco manufacturers.

    In response to the August 10, 2017 Notice, the Commission received comments from the Campaign for Tobacco-Free Kids (“CTFK”) and Altria Client Services (“Altria”).

    The CTFK comment specifically noted the utility and importance of the Commission's Cigarette and Smokeless Tobacco Reports, and urged the agency to continue collecting and reporting industry sales and marketing expenditure data, which CTFK stated provide “critical data to researchers, policymakers, advocates and the general public.” CTFK additionally observed:

    The FTC is currently the primary source for data on cigarette and smokeless tobacco companies' marketing and promotional expenditures. No other agency collects and publishes such information directly from the companies, making the FTC reports the most accurate and reliable assessment of tobacco marketing and promotion expenditures available.

    CTFK at 1.

    CTFK, however, suggested certain modifications to the Commission's reports. Specifically, CTFK recommended that the Commission: (1) Report separately price discount expenditures for retailers and wholesalers; (2) clarify the definitions of certain expenditure categories—specifically, in which category coupons that consumers obtain online are to be counted; (3) report data on a company-specific or brand-specific basis, rather than on a fully-aggregated basis; (4) require manufacturers to report expenditures related to corporate sponsorships and advertisements; and (5) provide an option to download the published report data in spreadsheet format. Id. at 2.

    The Commission agrees that collecting and reporting separately price discount expenditures for retailers and wholesalers is useful. Beginning with its 6(b) Orders for 2014, the Commission has been separately collecting and reporting information about price discounts paid to retailers and price discounts paid to wholesalers.

    The Commission will clarify in future Orders that expenditures on coupons delivered online should be reported together with coupons delivered by other means. The full impact of couponing by the major cigarette and smokeless tobacco manufacturers can only be seen if expenditures for all coupons are reported together, regardless of how those coupons are delivered to consumers.

    Regarding CTFK's suggestion that data be reported on other than a fully-aggregated, nationwide basis, the cigarette and smokeless tobacco companies assert that those data are confidential and, as CTFK acknowledges, the Commission cannot publicly release trade secrets or certain commercial or financial information. Id. at 2 n.2.

    As for requiring manufacturers to report expenditures related to corporate sponsorships and advertisements, the Commission already requires the recipients of its 6(b) Orders to report certain expenditures made in the name of the company, rather than any of its brands.1 However, the Commission does not include those data in its Cigarette and Smokeless Tobacco Reports. The Commission will consider whether those expenditures should be reported in the future or whether to cease collecting this information.

    1 Both the cigarette and smokeless tobacco Orders require the recipients to report expenditures on “public entertainment events (including, but not limited to, concerts and sporting events) bearing or otherwise displaying the name of the Company or any variation thereof but not bearing or otherwise displaying the name, logo, or an image of any portion of the package” of any of its cigarettes or smokeless tobacco products, or otherwise referring to those products.

    The Commission agrees that it would be helpful to provide an option to download the published report data in spreadsheet format and will begin doing so with its next published reports.

    Altria stated that the Commission should no longer collect any information from cigarette and smokeless tobacco manufacturers “in light of the Food and Drug Administration's . . . extensive, active regulatory authority over tobacco products under the Family Smoking Prevention and Tobacco Control Act,” calling such collections “superfluous” and “unnecessary burdens.” Altria at 1, 3. Altria contends that the FTC's most recent requests seek “not only information that the companies already produce to FDA, but also information unrelated to the advertising and promotion of tobacco products.” Id. at 3-4. It gives the following examples:

    (a) cigarette design data, including cigarette length, style, flavor, and filter type; (b) constituent data, including nicotine, carbon monoxide, and tar; (c) lists of cigarettes first sold or discontinued in 2016; and (d) lists of other product information, including brand varieties, pack size, and package type.

    Id. at 4 n.15. Altria also suggests that the FTC has recently expanded its requests to seek information on expenditures from parent companies that do not sell or advertise tobacco products. Id. at 3.

    The FTC staff and FDA staff have a long tradition of working together on the many areas where the two agencies share jurisdiction. The FDA is not collecting cigarette or smokeless tobacco sales and marketing expenditure data like that required by the Commission's 6(b) Orders, so there is no overlap or duplication with respect to such data. Moreover, to the extent there might be some overlap in the collection of information about whether brand styles of cigarettes are filtered or unfiltered, menthol or non-menthol, and their cigarette length, the Commission needs those data so it can combine them with sales information for each brand style in order to report the percentages of cigarettes sold by the leading manufacturers falling into each product type category (e.g., 26% of the cigarettes sold by these manufacturers in 2015 were menthol). FDA is not collecting cigarette sales information, so it cannot calculate sales percentages by product types. The Commission intends to continue collecting cigarette and smokeless tobacco sales and marketing expenditure data, together with cigarette length, flavor, and filter information. To the extent that in the future the FDA duplicates the FTC's data collection, the FTC can modify or cease its collection.

    Until 2000, the Commission collected cigarette tar, nicotine, and carbon monoxide yields and published that information by brand style. Because of concerns that the yield information was misleading consumers, the Commission ceased publishing that information, but it has continued to collect tar, nicotine, and carbon monoxide yields to the extent recipients of the 6(b) Orders possess it, and the Commission releases the data to researchers in response to Freedom of Information Act requests. In recent years, however, there have been very few requests for the data. Given that the Commission no longer publishes tar, nicotine, and carbon monoxide reports and the limited interest in these data, the Commission intends to cease collecting tar, nicotine, and carbon monoxide yield data.

    There are other information fields that the Commission no longer needs to collect, including information about cigarette package type, cigarette package size, cigarette styles, and whether a cigarette variety's tar yield and its nicotine yield are disclosed on its package. The Commission intends to continue to collect UPC-Codes in order to distinguish one variety from another, but does not need any other variety descriptors beyond cigarette length, flavor, and filter information. The Commission also no longer needs lists of cigarettes first sold or discontinued in a calendar year.

    Contrary to Altria's suggestion, the FTC did not recently expand its requests to seek information from parent companies. More than a decade ago, the Commission began directing its orders to the ultimate domestic parents of the cigarette and smokeless tobacco manufacturers because some parent companies owned more than one subsidiary selling those products and the Commission wanted to ensure that no relevant data from affiliated companies went unreported. Moreover, the 6(b) Orders ask several questions about whether the recipient engages in certain practices, such as paying for cigarette or smokeless tobacco product placement in movies, and the Commission wants to be sure that such practices by any related company are reported, even if that company does not itself sell cigarette or smokeless tobacco products. The Commission intends to continuing directing its 6(b) Orders to the parent companies of the leading cigarette and smokeless tobacco manufacturers.

    Burden Statement:2

    2 The details and assumptions underlying these estimates were set forth in the August 10, 2017 Federal Register notice.

    Estimated Annual Burden: 1,980 hours.3

    3 The Commission intends to use this PRA clearance renewal to collect information from the companies concerning their marketing and sales activities for the years 2017, 2018, and 2019. The Commission expects to issue compulsory process orders seeking this information annually, but it is possible that orders might not be issued in any given year and that orders seeking information for two years would be issued the next year. The figures set forth in this notice for the estimated hours and labor costs associated with this information collection represent average annual burden over the course of the prospective PRA clearance.

    Estimated Number of Respondents: 15 maximum.

    These estimates include any time spent by separately incorporated subsidiaries and other entities affiliated with the ultimate parent companies that receive the information requests.

    Estimated Average Burden per Year per Respondent: 180 hours.

    (a) Information requests to the four largest cigarette companies and five largest smokeless tobacco companies, at a per company average each year of 180 hours = 1,620 hours, cumulatively, per year; and

    (b) Information requests to six additional respondents, of smaller size, at a per company average each year of 60 hours = 360 hours, cumulatively, per year.

    Estimated Annual Labor Cost: $198,000.

    Estimated Capital or Other Non-Labor Cost: De minimis.

    Request for Comment: You can file a comment online or on paper. For the Commission to consider your comment, we must receive it on or before December 18, 2017. Write “Tobacco Reports: Paperwork Comment, FTC File No. P054507” on your comment. Your comment—including your name and your state—will be placed on the public record of this proceeding, including, to the extent practicable, on the public Commission Web site, at http://www.ftc.gov/os/publiccomments.shtm.

    Postal mail addressed to the Commission is subject to delay due to heightened security screening. As a result, we encourage you to submit your comments online, or to send them to the Commission by courier or overnight service. To make sure that the Commission considers your online comment, you must file it at https://ftcpublic.commentworks.com/ftc/tobaccoreportspra, by following the instructions on the web-based form. When this Notice appears at http://www.regulations.gov/#!home, you also may file a comment through that Web site.

    If you file your comment on paper, write “Tobacco Reports: Paperwork Comment, FTC File No. P054507” on your comment and on the envelope, and mail your comment to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW., Suite CC-5610 (Annex J), Washington, DC 20580, or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW., 5th Floor, Suite 5610 (Annex J), Washington, DC 20024. If possible, submit your paper comment to the Commission by courier or overnight service.

    Because your comment will be placed on the publicly accessible FTC Web site at https://www.ftc.gov/, you are solely responsible for making sure that your comment does not include any sensitive or confidential information. In particular, your comment should not include any sensitive personal information, such as your or anyone else's Social Security number; date of birth; driver's license number or other state identification number, or foreign country equivalent; passport number; financial account number; or credit or debit card number. You are also solely responsible for making sure that your comment does not include any sensitive health information, such as medical records or other individually identifiable health information. In addition, your comment should not include any “trade secret or any commercial or financial information which . . . is privileged or confidential”—as provided by Section 6(f) of the FTC Act, 15 U.S.C. 46(f), and FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2)—including in particular competitively sensitive information such as costs, sales statistics, inventories, formulas, patterns, devices, manufacturing processes, or customer names.

    Comments containing material for which confidential treatment is requested must be filed in paper form, must be clearly labeled “Confidential,” and must comply with FTC Rule 4.9(c). In particular, the written request for confidential treatment that accompanies the comment must include the factual and legal basis for the request, and must identify the specific portions of the comment to be withheld from the public record. See FTC Rule 4.9(c). Your comment will be kept confidential only if the General Counsel grants your request in accordance with the law and the public interest. Once your comment has been posted on the public FTC Web site—as legally required by FTC Rule 4.9(b)—we cannot redact or remove your comment from the FTC Web site, unless you submit a confidentiality request that meets the requirements for such treatment under FTC Rule 4.9(c), and the General Counsel grants that request.

    The FTC Act and other laws that the Commission administers permit the collection of public comments to consider and use in this proceeding as appropriate. The Commission will consider all timely and responsive public comments that it receives on or before December 18, 2017. For information on the Commission's privacy policy, including routine uses permitted by the Privacy Act, see https://www.ftc.gov/site-information/privacy-policy.

    Comments on the information collection requirements subject to review under the PRA should additionally be submitted to OMB. If sent by U.S. mail, they should be addressed to Office of Information and Regulatory Affairs, Office of Management and Budget, Attention: Desk Officer for the Federal Trade Commission, New Executive Office Building, Docket Library, Room 10102, 725 17th Street NW., Washington, DC 20503. Comments sent to OMB by U.S. postal mail are subject to delays due to heightened security precautions. Thus, comments instead can also be sent via email to [email protected]

    David C. Shonka, Acting General Counsel.
    [FR Doc. 2017-24915 Filed 11-16-17; 8:45 am] BILLING CODE 6750-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-102 and CMS-105] Agency Information Collection Activities: Submission for OMB Review; Comment Request AGENCY:

    Centers for Medicare & Medicaid Services, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected; and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

    DATES:

    Comments on the collection(s) of information must be received by the OMB desk officer by December 18, 2017.

    ADDRESSES:

    When commenting on the proposed information collections, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be received by the OMB desk officer via one of the following transmissions: OMB, Office of Information and Regulatory Affairs, Attention: CMS Desk Officer, Fax Number: (202) 395-5806 OR, Email: [email protected].

    To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following:

    1. Access CMS' Web site address at Web site address at https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html.

    2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to [email protected]

    3. Call the Reports Clearance Office at (410) 786-1326.

    FOR FURTHER INFORMATION CONTACT:

    William Parham at (410) 786-4669.

    SUPPLEMENTARY INFORMATION:

    Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires federal agencies to publish a 30-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice that summarizes the following proposed collection(s) of information for public comment:

    1. Type of Information Collection Request: Reinstatement without change of a previously approved collection; Title of Information Collection: Clinical Laboratory Improvement Amendments of 1988 (CLIA) Budget Workload Reports and Supporting Regulations; Use: We will use the collected information to determine the amount of Federal reimbursement for surveys conducted. Use of the information includes program evaluation, audit, budget formulation and budget approval. Form CMS-102 is a multi-purpose form designed to capture and record all budget and expenditure data. Form CMS-105 captures the annual projected CLIA workload that the State survey agency will accomplish. Our regional offices also use the information to approve the annual projected CLIA workload. The information is required as part of the section 1864 agreement with the state. Form Numbers: CMS-102 and CMS-105 (OMB control number: 0938-0599); Frequency: Quarterly; Affected Public: State, Local, or Tribal Governments; Number of Respondents: 50; Total Annual Responses: 50; Total Annual Hours: 1,700. (For policy questions regarding this collection contact Jeffrey Pleines at 410-786-0684.)

    Dated: November 14, 2017. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs.
    [FR Doc. 2017-25008 Filed 11-16-17; 8:45 am] BILLING CODE 4120-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Proposed Information Collection Activity; Comment Request

    Proposed Projects:

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

    OMB No.: 0970-0401.

    Description: Executive Order 12862 directs Federal agencies to provide service to the public that matches or exceeds the best service available in the private sector. In order to work continuously to ensure that the Administration for Children and Families' programs are effective and meet our customers' needs we use a generic clearance process to collect qualitative feedback on our service delivery. This collection of information is necessary to enable ACF to garner customer and stakeholder feedback in an efficient timely manner, in accord with our commitment to improving service delivery. The information collected from our customers and stakeholders will help ensure that users have an effective, efficient and satisfying experience with the programs. 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 change in operation might improve delivery of products or services. These collections will allow for ongoing, collaborative and actionable communications between ACF and its customer and stakeholders. It will also allow feedback to contribute directly to the improvement of program management.

    This request is an extension of the “generic fast-track” process offered to all government agencies by OMB in 2010. Fast-tack means each request receives approval five days after submission, if no issues are brought to ACF's attention by OMB within the five days.

    Respondents:

    Annual Burden Estimates Instrument Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Average
  • burden hours
  • per response
  • Total burden hours
    Survey 10,000 1 0.5 5,000

    Estimated Total Annual Burden Hours:

    In compliance with the requirements of Section 506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 370 L'Enfant Promenade SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. Email address: [email protected]. All requests should be identified by the title of the information collection.

    The Department specifically requests comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication.

    Robert Sargis, Reports Clearance Officer.
    [FR Doc. 2017-24902 Filed 11-16-17; 8:45 am] BILLING CODE 4184-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Submission for OMB Review; Comment Request

    Title: Variations in Implementation of Quality Interventions (VIQI) Project: Data Collection.

    OMB No.: New Collection.

    Description: The Administration for Children and Families (ACF), Office of Planning, Research and Evaluation (OPRE) proposes to collect information as part of the Variations in Implementation of Quality Interventions (VIQI): Examining the Quality-Child Outcomes Relationship in Child Care and Early Education Project.

    The VIQI Project will inform policymakers, practitioners, and stakeholders about effective ways to support the quality and effectiveness of early care and education (ECE) centers for promoting young children's learning and development. In partnership with ECE centers across the United States that serve young children with diverse economic backgrounds, the VIQI Project aims to (1) identify dimensions of quality within ECE settings that are key levers for promoting children's outcomes; (2) inform what levels of quality are necessary to successfully support children's developmental gains; (3) identify drivers that facilitate and inhibit successful implementation of interventions aimed at strengthening quality; and (4) understand how these relations vary across different ECE settings, staff, and children. To achieve these aims, the VIQI Project will include a year-long pilot study that will pilot up to three curricular and professional development models, followed by a year-long impact evaluation and process study that involve testing the effectiveness of two curricular and professional development models that aim to strengthen teacher practices, the quality of classroom processes, and children's outcomes. The study will include up to 189 community-based and Head Start ECE centers spread across seven different metropolitan areas in the United States.

    To test the effectiveness of the curricular and professional development models, the VIQI project will consist of a 3- or 4-group experimental design in the pilot study and a 3-group experimental design in the impact evaluation and the process study in which the initial quality and other characteristics of ECE centers are measured. The centers then will be stratified based upon select information collected—by setting type (e.g., Head Start and community-based ECE centers) and initial levels of quality—and randomly assigned to one of the intervention conditions where they will be offered curricular and professional development supports aimed at strengthening the quality of classroom and teacher practices, or to a business-as-usual comparison condition.

    In the pilot study, 24 centers in one metropolitan area will participate in the VIQI Project. Information about center and staff characteristics and classroom and teacher practices will be collected (1) to stratify and randomly assign centers; (2) to describe how the different interventions are implemented and are experienced by centers and teachers; and (3) to document the treatment differentials across research conditions. The information will then be used to adjust and to refine the research design and measures that will be used in the impact evaluation and process study.

    In the impact evaluation and process study, 165 centers in seven metropolitan areas will participate in the VIQI Project. Information about center and staff characteristics and classroom and teacher practices will be collected (1) to stratify and randomly assign centers; (2) to identify subgroups of interest; (3) to describe how the interventions are implemented and are experienced by centers and teachers; (4) to document the treatment differentials across research conditions; and (5) to assess the impacts of each of the interventions on different dimensions of quality and teacher practices when compared to a business-as-usual comparison condition for the impact evaluation sample and separately for subgroups of interest. In addition, information about the background characteristics of families and children being served in the centers will be collected, as well as measures of children's skills at the beginning and end of the year-long impact evaluation for a subset of children in these centers. This information will also be used (1) to define subgroups of interest defined by family and child characteristics, and (2) to assess the impacts of each of the interventions on children's skills for the full impact evaluation sample and separately for subgroups of interest. Lastly, the information on quality, teacher practices and children's skills will be used in a set of analyses that will rigorously examine the nature of the quality-to-child outcomes relationship by exploring the effects of different dimensions and thresholds (or levels) of quality on child outcomes for the full impact evaluation sample and separately for subgroups of interest.

    The data collection instruments for the VIQI Project include the following:

    (1) Instruments for Screening and Recruitment of ECE Centers will be used in the pilot study, impact evaluation, and process study to assess ECE centers' eligibility, to inform the sampling strategy, and to recruit ECE centers to participate in the VIQI Project;

    (2) Baseline Instruments for the Pilot Study, Impact Evaluation, and Process Study will be used to collect background information about centers, classrooms, center staff, and families and children being served in the centers. All of the instruments will be administered at the beginning of the pilot study, impact evaluation, and process study, with the exception of the baseline survey administered to parents of children enrolled in participating ECE centers and the protocol for baseline assessments of children's skills at the beginning of the impact evaluation and process study;

    (3) Follow-Up Instruments for the Pilot Study, Impact Evaluation, and Process Study will be used to inform how centers, classrooms, teachers, and children changed and to assess the impacts of each of the interventions over the course of the pilot study, impact evaluation, and process study. All of the instruments will be administered at the end of the pilot study, impact evaluation, and process study, with the exception of the protocol for follow-up assessments of children's skills at the end of the impact evaluation and process study; and,

    (4) Fidelity of Implementation Instruments for Pilot Study and Process Study will be used to document how the curricular and professional development models are delivered and experienced by staff, to document treatment differentials across research conditions, and to provide context for interpreting the findings of the impact evaluation.

    Respondents: The target population of the VIQI Project will include staff members working in Head Start grantee and community-based child care oversight agencies, staff members working in 189 ECE centers in seven metropolitan areas across the United States, and parents and children being served in these centers.

    Annual Burden Estimates Instrument Total
  • number of
  • respondents
  • Annual
  • number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Average
  • burden hours
  • per response
  • Annual
  • burden hours
  • Instruments for Screening and Recruitment of ECE Centers Landscaping protocol with Stakeholder Agencies (staff burden in Head Start (HS) grantee and community-based child care agencies) 100 33 1 1.50 50 Screening protocol for phone calls (staff burden in HS grantees and community-based child care agencies) 110 37 1 2 74 Screening protocol for phone calls (HS and community-based child care center staff burden) 280 93 1 1.20 112 Protocol for in-person visits for screening and recruitment activities (staff burden in HS grantees and community-based child care agencies) 488 163 1 1.50 245 Protocol for in-person visits for screening and recruitment activities (HS and community-based child care center staff burden) 760 253 1 1.20 304 Baseline Instruments for the Pilot Study, Impact Evaluation, and Process Study Baseline administrator survey 236 79 1 0.60 47 Baseline coach survey 223 74 1 0.60 44 Baseline teacher/assistant teacher survey 1,358 453 1 0.60 272 Baseline parent/guardian information form in Impact Evaluation only 8,568 2,856 1 0.20 571 Baseline classroom observation protocol (teacher burden) 543 181 1 0.30 54 Baseline protocol for child assessments in Impact Evaluation only (child burden) 1,980 660 1 0.50 330 Follow-Up Instruments for Pilot Study, Impact Evaluation, and Process Study Follow-up administrator survey 189 63 1 0.50 32 Follow-up coach survey 178 59 1 0.50 30 Follow-up teacher/assistant teacher survey 1,086 362 1 0.75 272 Teacher reports to questions about children in classroom (administered as part of the follow-up teacher survey) 543 181 1 0.67 121 Follow-up classroom observation protocol (teacher burden) 543 181 2 0.30 109 Follow-up protocol for child assessments in Impact Evaluation only (child burden) 1,980 660 1 1 660 Fidelity of Implementation Instruments for Pilot Study and Process Study Coach log 117 39 55 0.25 536 Teacher/assistant teacher log 1,086 362 36 0.25 3258 Implementation fidelity observation protocol (teacher burden) 72 24 1 0.30 7 Interview/Focus group protocol (administrator, teacher/assistant teacher and coach burden) 322 107 1 1.5 161

    Estimated Total Annual Burden Hours: 7,289.

    Additional Information: Copies of the proposed collection may be obtained by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 330 C Street, SW., Washington, DC 20201, Attn: OPRE Reports Clearance Officer. All requests should be identified by the title of the information collection. Email address: [email protected]

    OMB Comment: OMB is required to make a decision concerning the collection of information between 30 and 60 days after publication of this document in the Federal Register. Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. Written comments and recommendations for the proposed information collection should be sent directly to the following: Office of Management and Budget, Paperwork Reduction Project, Email: [email protected], Attn: Desk Officer for the Administration for Children and Families.

    Mary Jones, ACF/OPRE Certifying Officer.
    [FR Doc. 2017-24901 Filed 11-16-17; 8:45 am] BILLING CODE 4184-23-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Proposed Information Collection Activity: Comment Request

    Proposed Projects:

    Community Services Block Grant (CSBG) State Plan Application for States Community Services Block Grant (CSBG) Eligible Entity Master List Community Services Block Grant (CSBG) ACSI Survey of Eligible Entities

    Title: Community Services Block Grant (CSBG) State Plan Application

    OMB Number: 0970-0382

    Description: Section 676 of the Community Services Block Grant (CSBG) Act requires states, including the District of Columbia and the Commonwealth of Puerto Rico, and U.S. territories applying for CSBG funds to submit an application and plan (CSBG State Plan). The CSBG State Plan must meet statutory requirements prior to states and territories being funded with CSBG funds. Applicants have the option to submit a detailed plan annually or biannually. Entities that submit a biannual plan must provide an abbreviated plan the following year if substantial changes to the initial plan will occur.

    This request is to revise the automated CSBG State Plan format for states and territories by revising questions for clarity and system compatibility. It is not anticipated that these revisions will cause any additional burden to states as they have been completing the automated plan for three years. It is anticipated that the burden will continue to diminish in subsequent years due to improved automation.

    In addition to the CSBG State Plan, states will be requested to complete a CSBG Eligible Entity Master List in year one, and then make updates as necessary in subsequent years. As the states have the information about their eligible entities (or sub-grantees), the burden will be minimal to the states to complete this the first year.

    Lastly, the request includes a survey for the CSBG eligible entities (or sub-grantees). The survey focuses on the customer service that the eligible entities receive from the CSBG states. The survey is optional, and this will be the third time that the eligible entities that chose to submit will complete it.

    Respondents: State Governments, including the District of Columbia and the Commonwealth of Puerto Rico, and U.S. territories, and local level sub-grantees.

    Annual Burden Estimates Instrument Number of
  • respondents
  • Number of
  • responses per respondent
  • Average
  • burden hours per
  • response
  • Total burden hours
    CSBG State Plan Application for States 56 1 31 1,736 CSBG State Plan Eligible Entity List 56 1 1 56 CSBG ACSI Survey of Eligible Entities 1,019 1 .15 152.85

    Estimated Total Annual Burden Hours: 1,792 hours for states and territories; 152.85 for eligible entities.

    In compliance with the requirements of the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. Chap. 35), the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 330 C Street SW., Washington, DC 20201. Attn: ACF Reports Clearance Officer. Email address: [email protected] All requests should be identified by the title of the information collection.

    The Department specifically requests comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication.

    Robert Sargis, Reports Clearance Officer.
    [FR Doc. 2017-24905 Filed 11-16-17; 8:45 am] BILLING CODE 4184-27-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-4179] Cardiac Troponin Assays; Public Workshop; Request for Comments; Extension of Comment Period AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice; extension of comment period.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is extending the comment period provided in the notice entitled “Cardiac Troponin Assays; Public Workshop; Request for Comments” that appeared in the Federal Register on July 31, 2017. That notice announced the public workshop and requested comments by November 28, 2017; FDA is extending the public workshop's comment period by 30 days to December 28, 2017, in response to requests for an extension to allow interested persons additional time to submit comments.

    DATES:

    FDA is extending the comment period for the public workshop “Cardiac Troponin Assays” published on July 31, 2017 (82 FR 35532). Submit either electronic or written comments by December 28, 2017.

    ADDRESSES:

    You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before December 28, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of December 28, 2017. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

    Electronic Submissions

    Submit electronic comments in the following way:

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

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

    Written/Paper Submissions

    Submit written/paper submissions as follows:

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

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

    Instructions: All submissions received must include the Docket No. FDA-2017-N-4179 for “Cardiac Troponin Assays; Public Workshop; Request for Comments.” Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

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

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

    FOR FURTHER INFORMATION CONTACT:

    Paula Caposino, Food and Drug Administration, Center for Devices and Radiological Health, 10903 New Hampshire Ave., Bldg. 66, Rm. 4644, Silver Spring, MD 20993, 301-796-6160, [email protected]

    SUPPLEMENTARY INFORMATION:

    In the Federal Register of July 31, 2017 (82 FR 35532), FDA published a notice announcing the public workshop entitled “Cardiac Troponin Assays; Public Workshop; Request for Comments” with a 120-day comment period to request comments.

    The Agency has received requests for a 30-day extension of the comment period for the public workshop. The request conveyed concern that the current 120-day comment period does not allow sufficient time to develop a meaningful or thoughtful response to the public workshop.

    FDA has considered the request and is extending the comment period for the public workshop for 30 days, until December 28, 2017. The Agency believes that a 30-day extension allows adequate time for interested persons to submit comments.

    Dated: November 13, 2017. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2017-24922 Filed 11-16-17; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-D-6154] Evaluation of Devices Used With Regenerative Medicine Advanced Therapies; 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 document entitled “Evaluation of Devices Used with Regenerative Medicine Advanced Therapies; Draft Guidance for Industry.” The draft guidance document, when finalized, will provide device manufacturers, applicants, and sponsors engaged in the development of regenerative medicine therapies, with our current thinking regarding evaluation of devices used in the recovery, isolation or delivery of regenerative advanced therapies, which FDA generally refers to as “regenerative medicine advanced therapies” or “RMATs.” Specifically, as required by the 21st Century Cures Act (Cures Act), the draft guidance addresses how FDA intends to simplify and streamline its application of regulatory requirements for combination device and cell or tissue products; what, if any, intended uses or specific attributes would result in a device used with a regenerative therapy product to be classified as a class III device; when a device may be limited to a specific intended use with only one particular type of cell; and application of the least burdensome approach to demonstrate how a device may be used with more than one cell type.

    DATES:

    Submit either electronic or written comments on the draft guidance by February 15, 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 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-6154 for “Evaluation of Devices Used with Regenerative Medicine Advanced Therapies; Draft Guidance for Industry.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

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

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

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

    Submit written requests for single copies of the draft guidance to 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 the office in processing your requests. The draft 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 draft guidance document.

    FOR FURTHER INFORMATION CONTACT:

    Tami Belouin, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.

    SUPPLEMENTARY INFORMATION: I. Background

    FDA is announcing the availability of a draft document entitled “Evaluation of Devices Used with Regenerative Medicine Advanced Therapies; Draft Guidance for Industry.” The draft guidance, when finalized, will provide device manufacturers, applicants, and sponsors engaged in the development of regenerative medicine therapies, with our current thinking regarding evaluation of devices used in the recovery, isolation or delivery of regenerative advanced therapies, which FDA generally refers to as “regenerative medicine advanced therapies” or “RMATs”. Specifically, as required by section 3034 of the 21st Century Cures Act (Pub. L. 114-255) (Cures Act), the draft guidance addresses how FDA intends to simplify and streamline its application of regulatory requirements for combination device and cell or tissue products; what, if any, intended uses or specific attributes would result in a device used with a regenerative therapy product to be classified as a class III device; when a device may be limited to a specific intended use with only one particular type of cell; and application of the least burdensome approach to demonstrate how a device may be used with more than one cell type.

    The issuance of this draft guidance fulfills the statutory requirement set forth in section 3034(a) of the Cures Act. Furthermore, the Agency intends for this document, when finalized, to serve as a source of information about the Agency's current thinking about a wide range of concepts related to the regulation of devices, as they apply to devices used in the recovery, isolation, and delivery of RMATs. FDA has provided general information in the draft guidance in lieu of specific examples because the Agency does not yet possess a wide body of experience regarding the evaluation of devices used with RMATs, given the recent establishment of the RMAT designation program in the Cures Act.

    As we gain more experience with such devices, we intend to incorporate such information into the final guidance. To that end, although you are welcome to comment on any aspect of the guidance, we encourage commenters to support their comments with information related to specific marketed devices or types of devices that are used in the recovery, isolation, and delivery of RMATs.

    Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a document entitled “Expedited Programs for Regenerative Medicine Therapies for Serious Conditions; Draft Guidance for Industry.” Among other things, that document provides information about the RMAT designation program.

    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 Evaluation of Devices Used with Regenerative Medicine Advanced Therapies. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.

    II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 807 have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 812 have been approved under OMB control number 0910-0078; the collections of information in 21 CFR part 814 have been approved under OMB control number 0910-0231; and the collections of information in 21 CFR part 1271 have been approved under OMB control number 0910-0543.

    III. Electronic Access

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

    Dated: November 13, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
    [FR Doc. 2017-24836 Filed 11-16-17; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-N-0987] Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative Data on Tobacco Products and Communications AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the Generic Clearance for the Collection of Qualitative Data on Tobacco Products and Communications.

    DATES:

    Submit either electronic or written comments on the collection of information by January 16, 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 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-2014-N-0987 for “Generic Clearance for the Collection of Qualitative Data on Tobacco Products and Communications.” Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

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

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

    FOR FURTHER INFORMATION CONTACT:

    Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, [email protected]

    SUPPLEMENTARY INFORMATION:

    Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, 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.

    Generic Clearance for the Collection of Qualitative Data on Tobacco Products and Communications OMB Control Number 0910-0796—Extension

    Under section 1003(d)(2)(D) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 393(d)(2)(D)), FDA is authorized to conduct educational and public information programs.

    In conducting studies relating to the regulation and communications related to tobacco products, FDA will need to employ formative qualitative research including focus groups, usability testing, and/or indepth interviews (IDIs) to assess knowledge and perceptions about tobacco-related topics with specific target audiences. The information collected will serve three major purposes. First, formative research will provide critical knowledge about target audiences. FDA must first understand people's knowledge and perceptions about tobacco related topics prior to developing survey/research questions as well as stimuli for experimental studies. Second, by collecting communications usability information, FDA will be able to serve and respond to the ever-changing demands of consumers of tobacco products. Additionally, we will be able to determine the best way to present messages. Third, initial testing will allow FDA to assess consumer understanding of survey/research questions and study stimuli. Focus groups and/or IDIs with a sample of the target audience will allow FDA to refine the survey/research questions and study stimuli while they are still in the developmental stage. FDA will collect, analyze, and interpret information gathered through this generic clearance in order to: (1) Better understand characteristics of the target audience—its perceptions, knowledge, attitudes, beliefs, and behaviors—and use these in the development of appropriate survey/research questions, study stimuli, or communications; (2) more efficiently and effectively design survey/research questions and study stimuli; and (3) more efficiently and effectively design experimental studies.

    FDA is requesting approval of this new generic clearance for collecting information through the use of qualitative methods (i.e., individual interviews, small group discussions, and focus groups) for studies involving all tobacco products regulated by FDA. This information will be used as a first step to explore concepts of interest and assist in the development of quantitative study proposals, complementing other important research efforts in the Agency. This information may also be used to help identify and develop communication messages, which may be used in education campaigns. Focus groups play an important role in gathering information because they allow for an indepth understanding of individuals' attitudes, beliefs, motivations, and feelings. Focus group research serves the narrowly defined need for direct and informal public opinion on a specific topic.

    FDA estimates the burden of this collection of information as follows:

    Table 1—Estimated Annual Reporting Burden 1 Type of interview Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Total annual responses Average burden
  • per response
  • Total hours
    In-Person Individual Indepth Interviews 1,092 1 1,092 1 1,092 Indepth Interview (IDI) Screener 1,800 1 1,800 0.083 (5 minutes) 150 Focus Group Interviews 4,701 1 4,701 1.5 7,052 Focus Group Screener 3,996 1 3,996 0.25 (15 minutes) 999 Usability Testing 2,322 1 2,322 0.50 (30 minutes) 1,161 Usability Testing Screener 2,028 1 2,028 0.083 (5 minutes) 168 Total 10,622 1 There are no capital costs or operating and maintenance costs associated with this collection of information.

    The number of respondents to be included in each new pretest may vary, depending on the nature of the material or message being tested and the target audience. Table 1 provides examples of the types of studies that may be administered and estimated burden levels during the 3-year period. Time to read, view, or listen to the message being tested is built into the “Hours per Response” figures.

    The burden for this collection has decreased by 18,437 hours from 29,059 to 10,622. FDA attributes this decrease to assessing the planned studies for the next 3 years.

    Dated: November 9, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
    [FR Doc. 2017-24924 Filed 11-16-17; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-0001] Medical Gas Regulation; Public Workshops; Request for Comments AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of public workshops; request for comments.

    SUMMARY:

    The Food and Drug Administration (FDA, the Agency, or we) is announcing two public workshops entitled “Medical Gas Regulation: Workshop I” and “Medical Gas Regulation: Workshop II.” The topic to be discussed is potential areas of Federal drug regulation that should be revised with respect to medical gases.

    DATES:

    The first public workshop will be held on December 15, 2017, from 9 a.m. to 5 p.m. The second public workshop will be held on February 9, 2018, from 9 a.m. to 5 p.m. However, depending on the level of public participation, the workshops may end early. FDA may announce additional public workshop dates in the future, if needed.

    Submit either electronic or written comments on these public workshops by March 15, 2018, for Workshop I, and by May 10, 2018, for Workshop II. See the SUPPLEMENTARY INFORMATION section for registration dates and information.

    ADDRESSES:

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

    You may submit comments as follows. Please note that late, untimely filed comments may not be considered. For timely consideration, we request that electronic comments on workshop topics be submitted before or within 90 days after each workshop (i.e., comments should be submitted by or before March 15, 2018, for Workshop I, and May 10, 2018, for Workshop II). FDA will have one shared docket for all workshops. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of May 10, 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 the relevant 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-0001 for “Medical Gas Regulation.” 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:

    Christine Kirk, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-2465, Fax: 301-847-8440, email: [email protected]

    SUPPLEMENTARY INFORMATION: I. Background

    On May 5, 2017, President Trump signed the Consolidated Appropriations Act, 2017 (Pub. L. 115-31). Section 756 of the Consolidated Appropriations Act, 2017 requires FDA to issue final regulations revising Federal drug regulations with respect to medical gases. These public workshops are being held as part of FDA's implementation of the requirements of section 756.

    Since the 2012 enactment of the Food and Drug Administration Safety and Innovation Act (FDASIA) (Pub. L. 112-144), FDA has engaged in multiple activities related to medical gases, including rulemaking. For example, in 2016, FDA issued the final rule “Medical Gas Containers and Closures: Current Good Manufacturing Practice Requirements” (81 FR 81685, November 18, 2016). Other activities include FDA's June 2017 revised draft guidance for industry on current good manufacturing practice for medical gases,1 updated guidance for FDA inspectors regarding medical gases (March 2015),2 an extensive review of Federal drug regulations related to medical gases from 2012 to 2014 (a report on the review was submitted to Congress in 2015),3 and implementation of FDASIA's requirements regarding certification of medical gases (to date, over 70 certifications have been granted).

    1 Available at: https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm070270.pdf.

    2 Available at: https://www.fda.gov/downloads/ICECI/ComplianceManuals/ComplianceProgramManual/UCM125417.pdf.

    3 Available at: https://www.fda.gov/downloads/regulatoryinformation/lawsenforcedbyfda/significantamendmentstothefdcact/fdasia/ucm453727.pdf.

    FDA intends to engage in additional rulemaking in this area in accordance with section 756 of the Consolidated Appropriations Act, 2017. To conduct rulemaking as efficiently as possible, FDA intends to build on the information and stakeholder input received since FDASIA's enactment. As noted in more detail below, FDA invites comments from stakeholders on specific medical gas issues that could or should be addressed in regulation.

    II. Topics for Discussion at the Public Workshops

    We are holding these workshops to provide an opportunity for medical gas manufacturers and any other interested members of the public to provide input on potential areas of Federal drug regulation that should be revised with respect to medical gases.

    We are asking stakeholders to comment on existing medical gas issues which, in their view, should be addressed by regulation change (rather than through other means, such as revisions to guidance or inspection practices). Commenters should include concrete and specific reasons that rulemaking is preferable to other options. Commenters' views regarding the prioritization of particular rulemaking proposals would also be helpful. If a stakeholder would like a comment to be discussed at a particular public workshop, it should be submitted with a discussion request by no later than 1 week before the date of the workshop. If a stakeholder would like a comment to be included in FDA's consideration of public comments presented and received for a particular workshop, it should be submitted no later than 90 days after the date of the workshop. As noted above, the https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of May 10, 2018. Late comments will not be considered.

    During Workshop I (December 2017), FDA intends to discuss the anticipated scope of the medical gas rulemaking, as well as three regulations to which stakeholders have previously requested changes: 21 CFR part 201 (labeling generally and labeling for medical air specifically), 21 CFR part 207 (registration and listing), and 21 CFR parts 210 and 211 (current good manufacturing practice). Depending on the number of speakers and time available, we may also consider comments on additional regulations.

    During Workshop II (February 2018), FDA intends to discuss 21 CFR part 314 (adverse event reporting) and the intersection of regulations for medical gases and regulations for medical devices and animal drugs. Depending on the number of speakers and time available, we may also consider comments on additional regulations and medical gas issues not currently addressed in regulation. FDA is considering whether to schedule one or more additional public workshops in 2018 to hear from stakeholders regarding any remaining topics.

    III. Participating in the Public Workshops

    Registration: The workshops are free and seating will be on a first-come, first-served basis. Attendees who do not wish to make an oral presentation do not need to register.

    If you need special accommodations because of a disability, please contact [email protected] (or see FOR FURTHER INFORMATION CONTACT) at least 7 days in advance of each workshop.

    Requests for Oral Presentations: If you wish to a make an oral presentation, you must register by submitting your name, title, firm name, address, telephone, email address, and Fax number to [email protected] (see FOR FURTHER INFORMATION CONTACT) by December 8, 2017, for Workshop I, or February 2, 2018, for Workshop II. Please also indicate the type of organization you represent (e.g., industry, consumer organization) and a brief summary of your remarks (including the discussion topic(s) that you would like to address).

    FDA will try to accommodate all persons who wish to make a presentation; however, the duration of each speaker's presentation may be limited by time constraints. FDA will notify registered presenters of their scheduled presentation times. Persons registered to speak should check in before the workshops and are encouraged to arrive early to ensure their designated order of presentation. Participants who are not present when called may not be permitted to speak at a later time. An agenda will be made available at least 3 days before each workshop at https://www.fda.gov/Drugs/NewsEvents/ucm582091.htm. FDA may also post specific questions for consideration at the meeting Web page; these will be made available at least 3 days before each workshop at https://www.fda.gov/Drugs/NewsEvents/ucm582091.htm.

    Streaming Webcast and Video of the Public Workshops: These public workshops will be webcast; the URL will be posted at https://www.fda.gov/Drugs/NewsEvents/ucm582091.htm at least 1 day before each workshop. A video record of the public workshops will be available at the same Web site address for 1 year.

    Dated: November 13, 2017. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2017-24918 Filed 11-16-17; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0878] Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Notification for a New Dietary Ingredient AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the procedure by which a manufacturer or distributor of a new dietary ingredient or of a dietary supplement containing a new dietary ingredient is to submit to FDA information upon which it has based its conclusion that a dietary supplement containing the new dietary ingredient will reasonably be expected to be safe.

    DATES:

    Submit either electronic or written comments on the collection of information by January 16, 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 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-2013-N-0878 for “Premarket Notification for a New Dietary Ingredient.” 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:

    Ila Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [email protected]

    SUPPLEMENTARY INFORMATION:

    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.

    Premarket Notification for a New Dietary Ingredient—21 CFR 190.6 OMB Control Number 0910-0330—Extension

    This information collection supports Agency regulations. Specifically, section 413(a) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 350b(a)) provides that at least 75 days before the introduction or delivery for introduction into interstate commerce of a dietary supplement that contains a new dietary ingredient, the manufacturer or distributor of the dietary supplement or of the new dietary ingredient is to submit to FDA (as delegate for the Secretary of Health and Human Services) information upon which the manufacturer or distributor has based its conclusion that a dietary supplement containing the new dietary ingredient will reasonably be expected to be safe. FDA's implementing regulation, § 190.6 (21 CFR 190.6), requires this information to be submitted to the Office of Nutrition, Labeling, and Dietary Supplements (ONLDS) in the form of a notification. Under § 190.6(b), the notification must include the following: (1) The name and complete address of the manufacturer or distributor; (2) the name of the new dietary ingredient; (3) a description of the dietary supplement(s) that contain the new dietary ingredient, including the level of the new dietary ingredient in the dietary supplement and the dietary supplement's conditions of use; (4) the history of use or other evidence of safety establishing that the new dietary ingredient will reasonably be expected to be safe when used under the conditions recommended or suggested in the labeling of the dietary supplement; and (5) the signature of a responsible person designated by the manufacturer or distributor.

    These premarket notification requirements are designed to enable us to monitor the introduction into the marketplace of new dietary ingredients and dietary supplements that contain new dietary ingredients in order to protect consumers from ingredients and products whose safety is unknown. FDA uses the information collected in new dietary ingredient notifications to evaluate the safety of new dietary ingredients in dietary supplements and to support regulatory action against ingredients and products that are potentially unsafe.

    FDA has developed an electronic portal that respondents may use to electronically submit their notifications to ONLDS via FDA Unified Registration and Listing System (FURLS). Firms that prefer to submit a paper notification in a format of their own choosing still have the option to do so; however, Form FDA 3880 prompts a submitter to input the elements of a new dietary ingredient notification (NDIN) in a standard format and helps the respondent organize its NDIN to focus on the information needed for FDA's safety review. Safety information may be submitted via a supplemental form entitled “New Dietary Ingredient Safety Information.” This form provides a standard format to describe the history of use or other evidence of safety on which the manufacturer or distributor bases its conclusion that the new dietary ingredient is reasonably expected to be safe under the conditions of use recommended or suggested in the labeling of the dietary supplement, as well as related identity information that is necessary to demonstrate safety by showing that the new dietary ingredient and dietary supplement(s) that are the subject of the notification are the same or similar to the ingredients and products for which safety data and information have been provided. We invite comment on Form FDA 3880 and the supplemental safety information form, which may be found on our Web site at https://www.fda.gov/Food/DietarySupplements/NewDietaryIngredientsNotificationProcess/default.htm.

    Description of Respondents: The respondents to this collection of information are manufacturers and distributors in the dietary supplement industry; specifically, firms that manufacture or distribute new dietary ingredients or dietary supplements that contain a new dietary ingredient.

    FDA estimates the burden of this collection of information as follows:

    Table 1—Estimated Annual Reporting Burden 1 21 CFR section Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Total annual
  • responses
  • Average
  • burden per
  • response
  • (in hours)
  • Total hours
    190.6; Dietary Supplements 55 1 55 20 1,100 1 There are no capital costs or operating and maintenance costs associated with this collection of information.

    We have made no adjustments to the currently approved burden estimate for the information collection. While we have received previous comments suggesting our burden estimate may be too low, the comments did not discuss the basis for such a conclusion. We therefore specifically invite those commenters offering an alternative burden estimate to include the methodology or reasoning used to do so.

    Based on our experience with the information collection over the past 3 years, we estimate that 55 respondents will submit 1 premarket notification each. We estimate that extracting and summarizing the relevant information from what exists in the company's files and presenting it in a format that meets the requirements of § 190.6 will take approximately 20 hours of work per notification. We have carefully considered the burden associated with the premarket notification requirement and believe that estimates greater than 20 hours are likely to include burden associated with researching and generating safety data for a new dietary ingredient. We also believe that the burden of the premarket notification requirement on industry is minimal and reasonable because we are requesting only safety and identity information that the manufacturer or distributor should already have developed to satisfy itself that a dietary supplement containing a new dietary ingredient is in compliance with the FD&C Act. Under section 413(a)(2) of the FD&C Act, a dietary supplement that contains a new dietary ingredient is deemed to be adulterated unless there is a history of use or other evidence of safety establishing that the new dietary ingredient will reasonably be expected to be safe under the conditions of use recommended or suggested in the labeling of the dietary supplement. This requirement is separate from and additional to the requirement to submit a premarket notification for the new dietary ingredient. FDA's regulation on new dietary ingredient notifications, § 190.6(a), requires the manufacturer or distributor of the dietary supplement or of the new dietary ingredient to submit to FDA the information that forms the basis for its conclusion that a dietary supplement containing the new dietary ingredient will reasonably be expected to be safe. Thus, § 190.6 only requires the manufacturer or distributor to extract and summarize information that should have already been developed to meet the safety requirement in section 413(a)(2) of the FD&C Act.

    Dated: November 9, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
    [FR Doc. 2017-24925 Filed 11-16-17; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-D-0313] Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry, Researchers, Patient Groups, and Food and Drug Administration Staff on Meetings With the Office of Orphan Products Development AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the Guidance for Industry, Researchers, Patient Groups, and FDA Staff on Meetings with the Office of Orphan Products Development.

    DATES:

    Submit either electronic or written comments on the collection of information by January 16, 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 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-2014-D-0313 for “Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry, Researchers, Patient Groups, and Food and Drug Administration Staff on Meetings with the Office of Orphan Products Development.” Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

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

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

    FOR FURTHER INFORMATION CONTACT:

    Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, [email protected]

    SUPPLEMENTARY INFORMATION:

    Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, 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, Researchers, Patient Groups, and Food and Drug Administration Staff on Meetings With the Office of Orphan Products Development OMB Control Number 0910-0787—Extension

    This information collection supports Agency guidance regarding staff meetings with the Office of Orphan Products Development. Each year, the Office of Orphan Products Development (OOPD) staff participates in meetings with stakeholders who seek guidance or clarification relating to orphan drug or humanitarian use device (HUD) designation requests, OOPD grant programs, or other rare disease issues. These meetings can be “informal” or “formal” and help build a common understanding on FDA's thoughts on orphan products, which may include drugs, biological products, devices, or medical foods for a rare disease or condition. These meetings may represent critical points in the orphan product development process and may even have an impact on the eventual availability of products for patients with rare diseases and conditions. It is important that these meetings be scheduled within a reasonable time, conducted effectively, and documented where appropriate.

    Topics addressed in this guidance include: (1) Clarification of what constitutes an “informal” or “formal” meeting, (2) program areas within OOPD that may be affected by this draft guidance, (3) procedures for requesting and scheduling meetings with OOPD, (4) description of what constitutes a meeting package, and (5) procedures for the conduct and documentation of meetings with OOPD. This guidance provides consistent procedures to promote well-managed meetings between OOPD and stakeholders.

    Burden estimate. Table 1 of this document provides an estimate of the annual reporting burden associated with the recommendation found in the guidance.

    Request for a meeting. Based upon information collected from OOPD program areas, approximately 2,332 informal and 51 formal meetings were requested with OOPD in fiscal year (FY) 2016 regarding orphan drug designation requests, HUD designation requests, rare pediatric disease designation requests, funding opportunities through the Orphan Products Grants Program and the Pediatric Device Consortia Grants Program, and orphan product patient-related issues. FDA anticipates that the number of meeting requests and stakeholders will remain the same or will only slightly increase and therefore estimates the total number of meeting requests will be 2,383 annually (2332 informal and 51 formal meetings). The hours per response, which is the estimated number of hours that a stakeholder would spend preparing the information to be submitted with a meeting request in accordance with the guidance, is estimated to be approximately 3 hours for informal meetings and approximately 10 hours for formal meetings. Based on FDA's experience, the Agency expects that it will take stakeholders this amount of time to gather and copy brief statements about the product and a description of the purpose and details of the meeting. Therefore, the Agency estimates that stakeholders will spend 7,506 hours per year (6,996 hours for informal meetings and 510 hours for formal meetings) preparing meeting requests to OOPD regarding orphan drug designation requests, HUD designation requests, rare pediatric disease designation requests, funding opportunities through the Orphan Products Grants Program and the Pediatric Device Consortia Grants Program, and orphan product patient-related issues.

    Meeting packages. Based upon information collected from OOPD program areas, OOPD held approximately 51 formal meetings in FY 2016 regarding orphan drug designation requests, HUD designation requests, rare pediatric disease designation requests, funding opportunities through the Orphan Products Grants Program and the Pediatric Device Consortia Grants Program, and orphan product patient-related issues. FDA anticipates that the number of formal meetings, and therefore meeting packages, may increase only slightly as a result of this guidance; thus, the Agency estimates that the total responses will be 51 annually. As stated previously, it is current practice for stakeholders to submit meeting packages to the Agency in advance of any such formal meeting. The hours per response, which is the estimated number of hours that a stakeholder would spend preparing the meeting package in accordance with this guidance, is estimated to be approximately 18 hours. Based on FDA's experience, the Agency expects it will take stakeholders this amount of time to gather and copy brief statements about the product, a description of details for the anticipated meeting, and data and information that generally would already have been compiled for submission to the Agency. Therefore, the Agency estimates that stakeholders will spend 918 hours per year submitting meeting packages to the Agency prior to a formal meeting regarding orphan drug designation requests, HUD designation requests, rare pediatric disease designation requests, funding opportunities through the Orphan Products Grants Program and the Pediatric Device Consortia Grants Program, and orphan product patient-related issues.

    Draft meeting minutes. Based upon information collected from OOPD program areas, OOPD received approximately 51 draft meeting minutes for formal meetings and 23 draft meeting minutes for informal meetings in FY 2016 regarding orphan drug designation requests, HUD designation requests, rare pediatric disease designation requests, funding opportunities through the Orphan Products Grants Program and the Pediatric Device Consortia Grants Program, and orphan product patient-related issues. FDA anticipates that the number of stakeholders submitting draft meeting minutes may remain the same or increase only slightly; thus, the Agency estimates that the total number of respondents will be 74 annually. As stated previously, it is current practice for stakeholders to submit draft meeting minutes to the Agency after all formal meetings and certain informal meetings. The hours per response, which is the estimated number of hours that a stakeholder would spend preparing draft meeting minutes in accordance with this guidance, is estimated to be approximately 8 hours. Based on FDA's experience, the Agency expects it will take stakeholders this amount of time to summarize the meeting discussion points, agreements, disagreements, and action items. Therefore, the Agency estimates that stakeholders will spend 592 hours per year submitting draft meeting minutes to the Agency documenting the meeting outcomes, agreements, disagreements, and action items as followup to all formal and certain informal meetings.

    FDA therefore estimates the burden of this collection of information as follows:

    Table 1—Estimated Annual Reporting Burden 1 Meeting requests, packages and minutes Number of
  • respondents
  • Number of
  • responses per respondent
  • Total annual responses Average
  • burden per
  • response
  • Total hours
    Meeting requests (informal) 2,332 1 2,332 3 6,996 Meeting requests (formal) 51 1 51 10 510 Meeting packages 51 1 51 18 918 Meeting minutes 74 1 74 8 592 Total 9,016 1 There are no capital costs or operating and maintenance costs associated with this collection of information.

    Since the last OMB approval, we have increased our estimate by 832 hours and 229 respondents in parallel to an increase in overall orphan drug designation submissions and to correspond meeting requests to the Office of Orphan Products Development.

    Dated: November 9, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
    [FR Doc. 2017-24926 Filed 11-16-17; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-6175] Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration Recall Regulations AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on FDA recalls for human drugs, biological products, devices, animal drugs, food, cosmetics, and tobacco.

    DATES:

    Submit either electronic or written comments on the collection of information by January 16, 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 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-6175 for “Agency Information Collection Activities; Proposed Collection; Food and Drug Administration Recall Regulations.” 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:

    Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [email protected]

    SUPPLEMENTARY INFORMATION:

    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.

    FDA Recall Regulations—21 CFR Part 7 OMB Control Number 0910-0249—Extension

    Section 701 of the Federal Food, Drug, and Cosmetic Act charges the Secretary of Health and Human Services, through FDA, with the responsibility of assuring recalls (21 U.S.C. 371, Regulations and hearings, and 21 CFR part 7, Enforcement Policy, Subpart C, Recalls (Including Product Corrections)—Guidance on Policy, Procedures, and Industry Responsibilities which pertain to the recall regulations and provide guidance to manufacturers on recall responsibilities). The regulations and guidance apply to all FDA-regulated products (i.e., food, including animal feed; drugs, including animal drugs; medical devices, including in vitro diagnostic products; cosmetics; biological products intended for human use; and tobacco).

    These responsibilities of companies conducting recalls include providing FDA with complete details of the recall including: (1) Reason(s) for the removal or correction, risk evaluation, quantity produced, distribution information, firm's recall strategy, a copy of any recall communication(s), and a contact official (§ 7.46); (2) notifying direct accounts of the recall, providing guidance regarding further distribution, giving instructions as to what to do with the product, providing recipients with a ready means of reporting to the recalling firm (§ 7.49); and (3) submitting periodic status reports so that FDA may assess the progress of the recall. Status report information may be determined by, among other things, evaluation return reply cards, effectiveness checks and product returns (§ 7.53), and providing the opportunity for a firm to request in writing that FDA terminate the recall (§ 7.55(b)).

    A search of the FDA database was performed to determine the number of recalls that took place during fiscal years 2014 to 2016. The resulting number of total recalls (8,560) from this database search were then averaged over the 3 years, and the resulting per year average of recalls (2,853) are used in estimating the current annual reporting burden for this report. The resulting number of total terminations (8,560) from this database search were then averaged over the 3 years, and the resulting per year average of terminations (2,853) are used in estimating the current annual reporting burden for this report.

    FDA estimates the total annual industry burden to collect and provide the required information to be 470,745 burden hours.

    The following is a summary of the estimated annual burden hours for recalling firms (manufacturers, processors, and distributors) to comply with the reporting requirements of FDA's recall regulations, recognizing that there may be a vast difference in the information collection and reporting time involved in different recalls of FDA's regulated products.

    FDA estimates the burden of this collection of information as follows:

    Table 1—Estimated Annual Reporting Burden 1 21 CFR section Number of
  • respondents
  • Number of
  • responses per respondent
  • Total annual responses Average
  • burden per
  • response
  • Total hours
    Firm initiated recall (§ 7.46) and recall communications (§ 7.49) 2,853 1 2,853 25 71,325 Recall status reports (§ 7.53) 2,853 13 37,089 10 370,890 Termination of a recall (§ 7.55(b)) 2,853 1 2,853 10 28,530 Total 470,745 1 There are no capital costs or operating and maintenance costs associated with this collection of information.
    I. Total Annual Reporting A. Firm Initiated Recall and Recall Communications

    We request firms that voluntarily remove or correct foods and drugs (human or animal), cosmetics, medical devices, biologics, and tobacco to immediately notify the appropriate FDA District Office of such actions. The firm is to provide complete details of the recall reason, risk evaluation, quantity produced, distribution information, firms' recall strategy, and a contact official as well as requires firms to notify their direct accounts of the recall and to provide recipients with a ready means of reporting to the recalling firm. Under these portions of the collection of information, the Agency estimates it will receive 2,853 responses annually based on the average number of recalls over the last 3 fiscal years. The number of responses multiplied by the number of respondents equals 2,853. The average burden hours, 25, multiplied by total number of annual responses equal 71,325.

    B. Recall Status Reports

    We request that recalling firms provide periodic status reports so FDA can ascertain the progress of the recall. This request only applies to firms with active recalls, and periodic status reports are estimated to be reported every 2 to 4 weeks. This collection of information will generate approximately 2,853 responses annually, based on the average number of recalls over the last 3 fiscal years, 8,560. The number of respondents multiplied by the number of responses per respondents (13) equals a total number of annual responses of 37,089. The total number of responses, 37,089, multiplied by an average burden hours of 10 per response equals a total of 370,890 total hours.

    C. Termination of a Recall

    We provide the firms an opportunity to request in writing that FDA end the recall. The Agency estimates it will receive 2,853 responses annually based on the average number of terminations over the past 3 fiscal years. The total annual responses of 2,853 multiplied by the average burden hours of 10 per response equals a total number of hours of 28,530.

    II. Total Annual Third-Party Disclosure Burden

    Recall Communications. We request that firms notify their consignees of the recall and to provide recipients with a ready means of reporting to the recalling firm. Under this portion of the collection of information, the Agency estimates firms will provide 4,433,562 notifications annually based on the number of respondents/consignees (2,853) multiplied by the number of disclosures per respondent (1,554). The total number of hours is 248,279 (based on 4,433,562 multiplied by 0.056 hours).

    Table 2—Estimated Annual Third-Party Disclosure Burden 1 21 CFR section Number of
  • respondents
  • Number of
  • disclosures
  • per
  • respondent
  • Total annual disclosures Average
  • burden per
  • disclosure
  • Total hours
    Recall communications (§ 7.49) 2,853 1,554 4,433,562 0.056 248,279 1 There are no capital costs or operating and maintenance costs associated with this information collections.

    FDA regulates many different types of products including, but not limited to, medical products, food and feed, cosmetics, and tobacco products. FDA notes that not all third-party disclosures provided by firms to their consignees are similar in nature and may entail different methods and mediums of communication. FDA estimates the burden for third-party disclosure per recall event to be an average of 25 hours. This burden estimate factored out to the average number of consignees per recall (1,554) results in a burden per disclosure estimate of approximate hours (25 hours per recall/1,554 disclosures/recall = 0.056 hours).

    Dated: November 9, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
    [FR Doc. 2017-24923 Filed 11-16-17; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-6152] Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection of Zika Virus; Availability AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA) is announcing the issuance of two Emergency Use Authorizations (EUAs) (the Authorizations) for in vitro diagnostic devices for detection of the Zika virus in response to the Zika virus outbreak in the Americas. FDA issued these Authorizations under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by Siemens Healthcare Diagnostics, Inc. and Chembio Diagnostic Systems, Inc. The Authorizations contain, among other things, conditions on the emergency use of the authorized in vitro diagnostic devices. The Authorizations follow the February 26, 2016, determination by the Secretary of Health and Human Services (HHS) that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves Zika virus. On the basis of such determination, the Secretary of HHS declared on February 26, 2016, that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection, subject to the terms of any authorization issued under the FD&C Act. The Authorizations, which include an explanation of the reasons for issuance, are reprinted in this document.

    DATES:

    The Authorization for Siemens Healthcare Diagnostics, Inc. is effective as of September 18, 2017; the Authorization for Chembio Diagnostic Systems, Inc. is effective as of September 27, 2017.

    ADDRESSES:

    Submit written requests for single copies of the EUAs to the Office of Counterterrorism and Emerging Threats, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4338, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request or include a fax number to which the Authorizations may be sent. See the SUPPLEMENTARY INFORMATION section for electronic access to the Authorizations.

    FOR FURTHER INFORMATION CONTACT:

    Carmen Maher, Office of Counterterrorism and Emerging Threats, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4347, Silver Spring, MD 20993-0002, 301-796-8510 (this is not a toll free number).

    SUPPLEMENTARY INFORMATION:

    I. Background

    Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) as amended by the Project BioShield Act of 2004 (Pub L. 108-276) and the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (Pub L. 113-5) allows FDA to strengthen the public health protections against biological, chemical, nuclear, and radiological agents. Among other things, section 564 of the FD&C Act allows FDA to authorize the use of an unapproved medical product or an unapproved use of an approved medical product in certain situations. With this EUA authority, FDA can help ensure that medical countermeasures may be used in emergencies to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by biological, chemical, nuclear, or radiological agents when there are no adequate, approved, and available alternatives.

    Section 564(b)(1) of the FD&C Act provides that, before an EUA may be issued, the Secretary of HHS must declare that circumstances exist justifying the authorization based on one of the following grounds: (1) A determination by the Secretary of Homeland Security that there is a domestic emergency, or a significant potential for a domestic emergency, involving a heightened risk of attack with a biological, chemical, radiological, or nuclear agent or agents; (2) a determination by the Secretary of Defense that there is a military emergency, or a significant potential for a military emergency, involving a heightened risk to U.S. military forces of attack with a biological, chemical, radiological, or nuclear agent or agents; (3) a determination by the Secretary of HHS that there is a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of U.S. citizens living abroad, and that involves a biological, chemical, radiological, or nuclear agent or agents, or a disease or condition that may be attributable to such agent or agents; or (4) the identification of a material threat by the Secretary of Homeland Security under section 319F-2 of the Public Health Service (PHS) Act (42 U.S.C. 247d-6b) sufficient to affect national security or the health and security of U.S. citizens living abroad.

    Once the Secretary of HHS has declared that circumstances exist justifying an authorization under section 564 of the FD&C Act, FDA may authorize the emergency use of a drug, device, or biological product if the Agency concludes that the statutory criteria are satisfied. Under section 564(h)(1) of the FD&C Act, FDA is required to publish in the Federal Register a notice of each authorization, and each termination or revocation of an authorization, and an explanation of the reasons for the action. Section 564 of the FD&C Act permits FDA to authorize the introduction into interstate commerce of a drug, device, or biological product intended for use when the Secretary of HHS has declared that circumstances exist justifying the authorization of emergency use. Products appropriate for emergency use may include products and uses that are not approved, cleared, or licensed under sections 505, 510(k), or 515 of the FD&C Act (21 U.S.C. 355, 360(k), and 360e) or section 351 of the PHS Act (42 U.S.C. 262). FDA may issue an EUA only if, after consultation with the HHS Assistant Secretary for Preparedness and Response, the Director of the National Institutes of Health, and the Director of the Centers for Disease Control and Prevention (to the extent feasible and appropriate given the applicable circumstances), FDA 1 concludes: (1) That an agent referred to in a declaration of emergency or threat can cause a serious or life-threatening disease or condition; (2) that, based on the totality of scientific evidence available to FDA, including data from adequate and well-controlled clinical trials, if available, it is reasonable to believe that: (A) the product may be effective in diagnosing, treating, or preventing (i) such disease or condition; or (ii) a serious or life-threatening disease or condition caused by a product authorized under section 564, approved or cleared under the FD&C Act, or licensed under section 351 of the PHS Act, for diagnosing, treating, or preventing such a disease or condition caused by such an agent; and (B) the known and potential benefits of the product, when used to diagnose, prevent, or treat such disease or condition, outweigh the known and potential risks of the product, taking into consideration the material threat posed by the agent or agents identified in a declaration under section 564(b)(1)(D) of the FD&C Act, if applicable; (3) that there is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating such disease or condition; and (4) that such other criteria as may be prescribed by regulation are satisfied.

    1 The Secretary of HHS has delegated the authority to issue an EUA under section 564 of the FD&C Act to the Commissioner of Food and Drugs.

    No other criteria for issuance have been prescribed by regulation under section 564(c)(4) of the FD&C Act. Because the statute is self-executing, regulations or guidance are not required for FDA to implement the EUA authority.

    II. EUA Requests for In Vitro Diagnostic Devices for Detection of the Zika Virus

    On February 26, 2016, the Secretary of HHS determined that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves Zika virus. On February 26, 2016, under section 564(b)(1) of the FD&C Act, and on the basis of such determination, the Secretary of HHS declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection, subject to the terms of any authorization issued under section 564 of the FD&C Act. Notice of the determination and declaration of the Secretary was published in the Federal Register on March 2, 2016 (81 FR 10878). On September 8, 2017, Siemens Healthcare Diagnostics, Inc. requested, and on September 18, 2017, FDA issued, an EUA for the ADVIA Centaur Zika test, subject to the terms of the Authorization. On September 14, 2017, Chembio Diagnostic Systems, Inc. requested, and on September 27, 2017, FDA issued an EUA for the DPP Zika IgM Assay System, subject to the terms of the Authorization.

    III. Electronic Access

    An electronic version of this document and the full text of the Authorizations are available on the internet at https://www.regulations.gov/.

    IV. The Authorizations

    Having concluded that the criteria for issuance of the Authorizations under section 564(c) of the FD&C Act are met, FDA has authorized the emergency use of two in vitro diagnostic devices for detection of Zika virus subject to the terms of the Authorizations. The Authorizations in their entirety (not including the authorized versions of the fact sheets and other written materials) follow and provide an explanation of the reasons for issuance, as required by section 564(h)(1) of the FD&C Act:

    BILLING CODE 4164-01-P EN17NO17.020 EN17NO17.021 EN17NO17.022 EN17NO17.023 EN17NO17.024 EN17NO17.025 EN17NO17.026 EN17NO17.027 EN17NO17.028 EN17NO17.029 EN17NO17.030 EN17NO17.031 EN17NO17.032 EN17NO17.033 EN17NO17.034 EN17NO17.035 EN17NO17.036 EN17NO17.037 EN17NO17.038 EN17NO17.039 EN17NO17.040 EN17NO17.041 Dated: November 9, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
    [FR Doc. 2017-25010 Filed 11-16-17; 8:45 am] BILLING CODE 4164-01-C
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-D-6159] Expedited Programs for Regenerative Medicine Therapies for Serious Conditions; 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 document entitled “Expedited Programs for Regenerative Medicine Therapies for Serious Conditions; Draft Guidance for Industry.” The draft guidance, when finalized, will provide stakeholders engaged in the development of regenerative medicine therapies with FDA's current thinking on the expedited development and review of these products. The draft guidance describes the expedited programs available to sponsors of regenerative medicine therapies for serious or life-threatening diseases or conditions (referred to in the draft guidance as serious conditions), including those products designated as regenerative advanced therapies (which FDA refers to as “regenerative medicine advanced therapy” (RMAT) designation); describes how the Center for Biologics Evaluation and Research (CBER) will work with sponsors and encourage flexibility in clinical trial design to facilitate the development of data to demonstrate the safety and effectiveness of regenerative medicine therapies being developed to address unmet medical needs in patients with serious or life-threatening diseases or conditions; and describes the opportunities for sponsors of regenerative medicine therapies to interact with CBER review staff.

    DATES:

    Submit either electronic or written comments on the draft guidance by February 15, 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: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://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 http://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-6159 for “Expedited Programs for Regenerative Medicine Therapies for Serious Conditions; Draft Guidance for Industry.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://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 http://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

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

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

    Submit written requests for single copies of the draft guidance to the 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 the office in processing your requests. The draft 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 draft guidance document.

    FOR FURTHER INFORMATION CONTACT:

    Tami Belouin, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.

    SUPPLEMENTARY INFORMATION: I. Background

    FDA is announcing the availability of a draft document entitled “Expedited Programs for Regenerative Medicine Therapies for Serious Conditions; Draft Guidance for Industry.” The draft guidance document describes the expedited programs available to sponsors of regenerative medicine therapies for serious or life-threatening diseases or conditions (referred to in the draft guidance as serious conditions), including those products designated as RMATs; provides information about the provisions in the 21st Century Cures Act (Cures Act) (Pub. L. 114-225) regarding the use of the accelerated approval pathway for regenerative medicine therapies that have been granted designation as an RMAT; describes how CBER will encourage flexibility in clinical trial design to facilitate the development of data to demonstrate the safety and effectiveness of regenerative medicine therapies that are being developed to address unmet needs in patients with serious conditions; and describes the opportunities for sponsors of regenerative medicine therapies to interact with CBER review staff.

    The draft guidance document addresses regenerative medicine therapies, which are defined in section 506(g)(8) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Cures Act, as including cell therapies, therapeutic tissue engineering products, human cell and tissue products, and combination products using any such therapies or products, except for those regulated solely under section 361 of the Public Health Service Act (PHS Act) (42 U.S.C. 264) and 21 CFR part 1271. Gene therapies, including genetically modified cells, that lead to a durable modification of cells or tissues can meet the definition of a regenerative medicine therapy. Under section 506(g) of the FD&C Act, RMAT designation is available for a drug (i.e., a human drug, including a drug that is a biological product) that meets the definition of regenerative medicine therapy; is intended to treat, modify, reverse, or cure a serious or life-threatening disease or condition; and with respect to which preliminary clinical evidence indicates the potential to address unmet medical needs for such disease or condition. A combination product (biologic-device, biologic-drug, or biologic-device-drug) can be eligible for RMAT designation when the biological product provides the greatest contribution to the overall intended therapeutic effects of the combination product (i.e., the primary mode of action in the combination product is conveyed by the biological product component).

    Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a document entitled “Evaluation of Devices Used with Regenerative Medicine Advanced Therapies; Draft Guidance for Industry.”

    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 “Expedited Programs for Regenerative Medicine Therapies for Serious Conditions; Draft Guidance for Industry.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.

    II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 312 have been approved under OMB control number 0910-0014; the collections of information regarding formal meetings in “Guidance for Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products” have been approved under OMB control number 0910-0429; the collections of information in 21 CFR part 601 have been approved under OMB control number 0910-0338; the collections of information for expedited programs in “Guidance for Industry: Expedited Programs for Serious Conditions—Drugs and Biologics,” have been approved under OMB control number 0910-0765; the collections of information in 21 CFR part 314 have been approved under OMB control number 0910-0001.

    III. Electronic Access

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

    Dated: November 13, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
    [FR Doc. 2017-24837 Filed 11-16-17; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-D-1167] Controlled Correspondence Related to Generic Drug Development; Draft Guidance for Industry; Availability; Correction AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice; correction.

    SUMMARY:

    The Food and Drug Administration is correcting a notice entitled “Controlled Correspondence Related to Generic Drug Development; Draft Guidance for Industry; Availability” that appeared in the Federal Register of November 3, 2017. The document announced the availability of a draft guidance for industry. The document was published with the incorrect docket number. This document corrects that error.

    FOR FURTHER INFORMATION CONTACT:

    Lisa Granger, Office of Policy, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 32, Rm. 3330, Silver Spring, MD 20993-0002, 301-796-9115, [email protected]

    SUPPLEMENTARY INFORMATION:

    In the Federal Register of Friday, November 3, 2017 (82 FR 51277), in FR Doc. 2017-23947, the following correction is made:

    On page 51277, in the second column, in the header of the document, “[Docket FDA-2014-D-1147]” is corrected to read “[Docket No. FDA-2014-D-1167]”.

    Dated: November 9, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
    [FR Doc. 2017-24948 Filed 11-16-17; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-D-2245] Unique Device Identification: Direct Marking of Devices; Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of availability.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled “Unique Device Identification: Direct Marking of Devices.” This document is intended to clarify when direct marking of devices with a unique device identifier (UDI) is required, and to assist industry and FDA staff in understanding direct marking requirements.

    DATES:

    The announcement of the guidance is published in the Federal Register on November 17, 2017.

    ADDRESSES:

    You may submit either electronic or written comments on Agency guidances at any time as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

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

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

    Written/Paper Submissions

    Submit written/paper submissions as follows:

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

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

    Instructions: All submissions received must include the Docket No. FDA-2015-D-2245 for “Unique Device Identification: Direct Marking of Devices.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

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

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

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

    An electronic copy of the guidance document is available for download from the internet. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written requests for a single hard copy of the guidance document entitled “Unique Device Identification: Direct Marking of Devices” to the Office of the Center Director, Guidance and Policy Development, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002, or the Office of Communication, Outreach, and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request.

    FOR FURTHER INFORMATION CONTACT:

    Christina Savisaar, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3303, Silver Spring, MD 20993-0002, 301-496-6404, email: [email protected]

    SUPPLEMENTARY INFORMATION: I. Background

    Section 801.45 (21 CFR 801.45) requires a device to be directly marked with a UDI when the device is intended to be used more than once and intended to be reprocessed before each use. However, “intended to be used more than once” and “intended to be reprocessed” are not defined in the UDI regulations. This guidance provides FDA's interpretation of these terms, clarifies when direct marking of devices with a UDI is required, provides recommendations for how labelers should comply with the UDI direct marking requirements, and clarifies the criteria for exceptions to the direct marking requirement.

    In the Federal Register of June 26, 2015, FDA published the notice of availability of “Draft Guidance for Industry and Food and Drug Administration Staff: Unique Device Identification: Direct Marking of Devices” (80 FR 36821) (the “Draft Guidance”). In the notice of availability, FDA also solicited feedback on two questions related to interpretation of “intended to be reprocessed”: (1) Should the definition of “reprocessing” for purposes of UDI direct marking requirements include cleaning alone without subsequent disinfection and/or sterilization of the device? and (2) what public health benefits would be served by requiring a UDI direct marking to be affixed to devices intended to be reused for which reprocessing instructions include cleaning only and not disinfection and/or sterilization? Interested persons were invited to comment by September 24, 2015. FDA considered the comments received on the draft guidance, including comments responding to the specific questions in the notice of availability, and revised the guidance as appropriate in response to these comments.

    II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on “Unique Device Identification: Direct Marking of Devices.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.

    III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by downloading an electronic copy from the internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm or https://www.regulations.gov. Persons unable to download an electronic copy of “Unique Device Identification: Direct Marking of Devices” may send an email request to [email protected] to receive an electronic copy of the document. Please use the document number 1400031 to identify the guidance you are requesting.

    IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of information described in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 801 have been approved under OMB control number 0910-0485; the collections of information in 21 CFR part 807, subpart E, have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 814, subparts A through E, have been approved under OMB control number 0910-0231; the collections of information in 21 CFR part 820 have been approved under OMB control number 0910-0073; and the collections of information in 21 CFR part 830 pertaining to GUDID labeler accounts and data submissions addressed in this draft guidance document have been approved under OMB control number 0910-0720.

    Dated: November 14, 2017. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2017-24992 Filed 11-16-17; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Mental Health; 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 Mental Health Special Emphasis Panel; Member Conflicts: Mental Health Services Research.

    Date: December 7, 2017.

    Time: 11:30 a.m. to 12:30 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852 (Telephone Conference Call).

    Contact Person: Karen Gavin-Evans, Ph.D., Scientific Review Officer, Division of Extramural Activities, National Institute of Mental Health, NIH, Neuroscience Center, 6001 Executive Boulevard, Room 6153, MSC 9606, Bethesda, MD 20892, 301-451-2356, [email protected].

    (Catalogue of Federal Domestic Assistance Program No. 93.242, Mental Health Research Grants, National Institutes of Health, HHS)
    Dated: November 13, 2017. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2017-24899 Filed 11-16-17; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Heart, Lung, and Blood Institute; Notice of Closed Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the NHLBI Institutional Training Mechanism Review Committee.

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

    Name of Committee: Heart, Lung, and Blood Initial Review Group; NHLBI Institutional Training Mechanism Review Committee.

    Date: December 8, 2017.

    Time: 9:00 a.m. to 4:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Room 7194, Bethesda, MD 20892 (Telephone Conference Call).

    Contact Person: Charles Joyce, Ph.D., Scientific Review Officer, Office of Scientific Review/DERA National Heart, Lung, and Blood Institute, 6701 Rockledge Drive, Room 7194, Bethesda, MD 20892-7924, 301-827-7939, [email protected].

    (Catalogue of Federal Domestic Assistance Program Nos. 93.233, National Center for Sleep Disorders Research; 93.837, Heart and Vascular Diseases Research; 93.838, Lung Diseases Research; 93.839, Blood Diseases and Resources Research, National Institutes of Health, HHS)
    Dated: November 9, 2017. Michelle Trout, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2017-24897 Filed 11-16-17; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Heart, Lung, and Blood Institute; Notice of Closed Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of meetings of the NHLBI Special Emphasis Panel.

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

    Name of Committee: National Heart, Lung, and Blood Institute Special Emphasis Panel; NHLBI SBIR Phase IIB Small Market Awards.

    Date: December 7, 2017.

    Time: 8:00 a.m. to 9:30 a.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: Susan Wohler Sunnarborg, Ph.D., Scientific Review Officer, Office of Scientific Review/DERA National Heart, Lung, and Blood Institute, 6701 Rockledge Drive, Room 7182, Bethesda, MD 20892, [email protected], 301-827-7987.

    Name of Committee: National Heart, Lung, and Blood Institute Special Emphasis Panel; NHLBI SBIR Phase IIB Bridge Awards.

    Date: December 7, 2017.

    Time: 9:30 a.m. to 5:00 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: Susan Wohler Sunnarborg, Ph.D., Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, 6701 Rockledge Drive, Room 7182, Bethesda, MD 20892, [email protected], 301-827-7987.

    (Catalogue of Federal Domestic Assistance Program Nos. 93.233, National Center for Sleep Disorders Research; 93.837, Heart and Vascular Diseases Research; 93.838, Lung Diseases Research; 93.839, Blood Diseases and Resources Research, National Institutes of Health, HHS)
    Dated: November 13, 2017. Michelle Trout, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2017-24896 Filed 11-16-17; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting

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

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

    Name of Committee: National Institute on Alcohol Abuse and Alcoholism Special Emphasis Panel; AA-1 and AA-4 Conflict Applications.

    Date: December 11, 2017.

    Time: 1:00 p.m. to 3:30 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, National Institute on Alcohol Abuse and Alcoholism, 5635 Fishers Lane, Bethesda, MD 20892 (Telephone Conference Call).

    Contact Person: Philippe Marmillot, Ph.D., National Institutes of Health, National Institute on Alcohol Abuse and Alcoholism, 5635 Fishers Lane, Room 2017, Bethesda, MD 20892, 301-443-2861, [email protected]

    (Catalogue of Federal Domestic Assistance Program Nos. 93.271, Alcohol Research Career Development Awards for Scientists and Clinicians; 93.272, Alcohol National Research Service Awards for Research Training; 93.273, Alcohol Research Programs; 93.891, Alcohol Research Center Grants; 93.701, ARRA Related Biomedical Research and Research Support Awards, National Institutes of Health, HHS)
    Dated: November 13, 2017. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2017-24898 Filed 11-16-17; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute; Notice of Closed Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following 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 purpose of this meeting is to evaluate requests for preclinical development resources for potential new therapeutics for the treatment of cancer. The outcome of the evaluation will provide information to internal NCI committees that will decide whether NCI should support requests and make available contract resources for development of the potential therapeutic to improve the treatment of various forms of cancer. The research proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the proposed research projects, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Cancer Institute Special Emphasis Panel; Oct2017 Cycle 27 NExT SEP Committee Meeting.

    Date: December 13, 2017.

    Time: 8:30 a.m. to 4:30 p.m.

    Agenda: To evaluate the NCI Experimental Therapeutics Program Portfolio.

    Place: National Institutes of Health, 9000 Rockville Pike, Building 31, Wing C, 6th Floor, Conference Room 10, Bethesda, MD 20892.

    Contact Persons: Barbara Mroczkowski, Ph.D., Executive Secretary, Discovery Experimental Therapeutics Program, National Cancer Institute, NIH, 31 Center Drive, Room 3A44, Bethesda, MD 20817, (301) 496-4291, [email protected]

    Toby Hecht, Ph.D., Executive Secretary, Development Experimental Therapeutics Program, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 3W110, Rockville, MD 20850, (240) 276-5683, [email protected]

    (Catalogue of Federal Domestic Assistance Program Nos. 93.392, Cancer Construction; 93.393, Cancer Cause and Prevention Research; 93.394, Cancer Detection and Diagnosis Research; 93.395, Cancer Treatment Research; 93.396, Cancer Biology Research; 93.397, Cancer Centers Support; 93.398, Cancer Research Manpower; 93.399, Cancer Control, National Institutes of Health, HHS)
    Dated: November 13, 2017. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2017-24895 Filed 11-16-17; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Notice of Meeting for the Interdepartmental Serious Mental Illness Coordinating Committee (ISMICC) AGENCY:

    Substance Abuse and Mental Health Services Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Secretary of Health and Human Services (Secretary), in accordance with section 6031 of the 21st Century Cures Act, announces a meeting of the Interdepartmental Serious Mental Illness Coordinating Committee (ISMICC). The meeting will be held virtually by webcast.

    DATES:

    The ISMICC will meet on December 14, 2017, from 10:30 a.m. to 12:00 p.m., Eastern Daylight Time.

    SUPPLEMENTARY INFORMATION:

    The meeting will focus on the Report to Congress that includes information on federal advances related to serious mental illness (SMI) and serious emotional disturbance (SED), including data evaluation, and recommendations for action. Members of the public can attend the meeting via telephone or webcast. The meeting can be accessed via webcast at www.hhs.gov/live. To obtain the call-in number and access code, submit written or brief oral comments, or request special accommodations for persons with disabilities, please visit the SAMHSA Advisory Committees Web page at https://www.samhsa.gov/about-us/advisory-councils/smi-committee or contact Pamela Foote, Designated Federal Official (see contact information below).

    Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written statements should be submitted to the DFO on or before November 30, 2017. Oral presentations from the public will be scheduled at the conclusion of the meeting. Individuals interested in making oral presentations must notify the DFO on or before November 30, 2017. Two minutes will be allotted for each presentation as time permits. Substantive meeting information and a roster of Committee members is available at the Committee's Web site https://www.samhsa.gov/about-us/advisory-councils/smi-committee or by contacting Pamela Foote, DFO.

    Committee Name: Interdepartmental Serious Mental Illness Coordinating Committee

    Dates/Time/Type: Thursday, December 14, 2017, 10:30 a.m. 12:00 p.m./OPEN

    Place: Webcast and teleconference (see information above).

    Contact: Pamela Foote, Designated Federal Official, Substance Abuse and Mental Health Services Administration, 5600 Fishers Lane, Room14E53C, Rockville, MD 20857, Telephone: 240-276-1279, Fax: 301-480-8491, Email: [email protected].

    Background and Authority

    The ISMICC was established on March 15, 2017, in accordance with section 6031 of the 21st Century Cures Act, and the Federal Advisory Committee Act, 5 U.S.C. App., as amended, to report to the Secretary, Congress, and any other relevant federal department or agency on advances in serious mental illness (SMI) and serious emotional disturbance (SED), research related to the prevention of, diagnosis of, intervention in, and treatment and recovery of SMIs, SEDs, and advances in access to services and support for adults with SMI or children with SED. In addition, the ISMICC will evaluate the effect federal programs related to serious mental illness have on public health, including public health outcomes such as (A) rates of suicide, suicide attempts, incidence and prevalence of SMIs, SEDs, and substance use disorders, overdose, overdose deaths, emergency hospitalizations, emergency room boarding, preventable emergency room visits, interaction with the criminal justice system, homelessness, and unemployment; (B) increased rates of employment and enrollment in educational and vocational programs; (C) quality of mental and substance use disorders treatment services; or (D) any other criteria as may be determined by the Secretary. Finally, the ISMICC will make specific recommendations for actions that agencies can take to better coordinate the administration of mental health services for adults with SMI or children with SED. Not later than 1(one) year after the date of enactment of the 21st Century Cures Act, and 5 (five) years after such date of enactment, the ISMICC shall submit a report to Congress and any other relevant federal department or agency.

    This ISMICC consists of federal members listed below or their designees, and non-federal public members.

    A roster of Committee members is available at the Committee's Web site: https://www.samhsa.gov/about-us/advisory-councils/smi-committee

    The ISMICC is required to meet twice per year.

    Carlos Castillo, Committee Management Officer.
    [FR Doc. 2017-24876 Filed 11-16-17; 8:45 am] BILLING CODE 4162-20-P
    ADVISORY COUNCIL ON HISTORIC PRESERVATION Notice of Proposed Draft Program Comment To Exempt Effects of Transportation-Related Undertakings Within Rail Rights-of-Way AGENCY:

    Advisory Council on Historic Preservation.

    ACTION:

    Notice of availability and request for comments.

    SUMMARY:

    The Advisory Council on Historic Preservation, in coordination with the U.S. Department of Transportation, proposes a program comment to exempt effects of transportation-related undertakings within railroad and rail transit rights-of-way. This program comment would exempt from Section 106 review certain activities that have the potential to affect historic properties within railroad and rail transit rights-of-way where those effects are likely to be minimal or not adverse. Further, this program comment includes an optional approach that could streamline the Section 106 review for additional types of transportation-related undertakings involving railroad and rail transit properties, including those that may cause adverse effects. Issuance of this program comment would fulfill the requirements of Section 11504 of the Fixing America's Surface Transportation Act.

    DATES:

    Submit comments on or before December 8, 2017.

    ADDRESSES:

    Address all comments concerning the draft program comment to both the ACHP and the U.S. Department of Transportation's Federal Railroad Administration (FRA) by U.S. mail as follows: Charlene Dwin Vaughn, AICP, Office of Federal Agency Programs, Advisory Council on Historic Preservation, 401 F Street NW., Suite 308, Washington, DC 20001-2637, and Laura Shick, U.S. Department of Transportation, Federal Railroad Administration, Office of Railroad Policy and Development, RPD-13, 1200 New Jersey Avenue SE., Washington, DC 20590. Comments may also be submitted through electronic mail to [email protected] and [email protected] Please submit comments to both the ACHP and FRA to ensure timely consideration.

    FOR FURTHER INFORMATION CONTACT:

    Charlene Dwin Vaughn, Assistant Director, Federal Permitting, Licensing, and Assistance Section, Office of Federal Agency Programs, ACHP (202) 517-0207, [email protected]; Laura Shick, Federal Preservation Officer, Federal Railroad Administration, (202) 366-0340, [email protected]; or Sharyn LaCombe, Federal Preservation Officer, Federal Transit Administration, (202) 366-5213, [email protected]

    SUPPLEMENTARY INFORMATION:

    Section 106 of the National Historic Preservation Act (“NHPA”) (54 U.S.C. 306108) requires federal agencies to take into account the effects of undertakings they carry out, license, permit, or assist on historic properties and provide the Advisory Council on Historic Preservation (“ACHP”) a reasonable opportunity to comment with regard to such undertakings. Historic properties are those that are listed on the National Register of Historic Places (“National Register”) or eligible for such listing. The definition of historic properties and other terms relevant to the proposed Section 106 program comment for railroad and rail transit rights-of-way (“rail ROW”) are provided in Section VI, Definition of Terms, and are consistent with the NHPA and the Section 106 regulations.

    The Section 106 implementing regulations allow federal agencies to tailor the Section 106 process to meet their needs through a variety of program alternatives (36 CFR 800.14). Types of Section 106 program alternatives include program comments and exemptions. The process for establishing an exemption is detailed in 36 CFR 800.14(c). In accordance with 36 CFR 800.14(c)(1), the ACHP may approve an exemption for a program or category of undertakings if: (i) The actions within the program or category would otherwise qualify as “undertakings” as defined in 36 CFR 800.16; (ii) the potential effects of the undertakings within the program or category upon historic properties are foreseeable and likely to be minimal or not adverse; and (iii) exemption of the program or category is consistent with the purposes of the NHPA. The ACHP takes into account the magnitude of the exempted undertaking or program and the likelihood of impairment of historic properties in reviewing a proposed exemption. Further, at 36 CFR 800.14(e), the Section 106 implementing regulations provide a process for the ACHP to issue a program comment. Through a program comment, the ACHP comments on a category of undertakings in lieu of conducting individual reviews under 36 CFR 800.4-800.6.

    Section 11504 of the Fixing America's Surface Transportation Act (“FAST Act”) (49 U.S.C. 24202), enacted on December 4, 2015, mandated the development of a Section 106 exemption for “railroad rights-of-way.” The FAST Act requires that “the Secretary [of the United States Department of Transportation (“USDOT”)] shall submit a proposed exemption of railroad rights-of-way from the review under section 306108 of title 54 to the [ACHP] for consideration, consistent with the exemption for interstate highways approved on March 10, 2005 (70 FR 11928).” The FAST Act continues that, “Not later than 180 days after the date on which the Secretary submits the proposed exemption. . .to the Council, the Council shall issue a final exemption of railroad rights-of-way from review under chapter 3061 of title 54 consistent with the exemption for interstate highways approved on March 10, 2005 (70 FR 11928).” While the Section 106 regulations provide the process and criteria for development of program alternatives, the FAST Act modified the timeframe and directed agency actions.

    This proposed Section 106 program comment includes an activities-based exemption that would fulfill the FAST Act mandate by exempting certain routine transportation-related undertakings that occur within rail ROW. The list of activities proposed to be exempt from Section 106 review is provided in Appendix A. Based on the past experience of USDOT Operating Administrations (“USDOT OAs”), undertakings limited to the activities specified in Appendix A have typically resulted in effects to historic properties that are either minimal or not adverse. In addition to incorporating exempt activities that meet the criteria specified in the Section 106 regulations at 36 CFR 800.14(c)(1), this program comment includes an optional, Project Sponsor-led property-based approach that ultimately could provide additional streamlining for undertakings that may cause adverse effects.

    I. Background

    The railroad industry in the United States has developed for nearly two centuries. Ongoing activities such as maintenance, improvements, and upgrades are necessary to allow rail infrastructure to continue to serve the transportation needs of the nation safely and efficiently. Further, these activities when carried out properly preserve the infrastructure and historic transportation purpose of moving goods and passengers. Most of the nation's railroads are privately-owned and maintained through the continuous investments of private owners. According to the Association of American Railroads (AAR), privately-owned freight railroads spent more than $630 billion on rail equipment and infrastructure, including tracks, bridges, and tunnels, during the 36-year period from 1980 to 2016.1

    1https://www.aar.org/Pages/Railroad-101.aspx.

    The federal government also makes substantial investments in and has oversight of the nation's railroads and rail transit systems. This includes maintaining and expanding intercity passenger rail, rail transit, and freight rail services, and regulating and improving the safety and efficiency of rail operations. USDOT serves both an investment (e.g., grants, loans) role and a regulatory and safety oversight role, with activities carried out most frequently by the following USDOT OAs: The Federal Railroad Administration (“FRA”), the Federal Transit Administration (“FTA”), and the Federal Highway Administration (“FHWA”).

    For example, FRA provides financial and technical assistance for planning and infrastructure projects that enable the nation's railroads to move passengers and goods across the United States. FRA's investments are principally, but not exclusively, in support of intercity passenger rail operations and often provide financial assistance for maintenance, improvements, and upgrades to railroad infrastructure, equipment, and technologies, including those focused on improving the safety of railroad operations and roadway/railroad grade crossings, as well as for research and development activities and training. FTA provides financial and technical assistance to transit agencies for investment in public transportation systems that include various forms of rail transit that occupy existing or former rail ROW, such as heavy rail, commuter rail, streetcar, and light rail. FHWA supports state, local, and tribal governments and federal agencies in the design, construction, and maintenance of the nation's highway systems. Highways frequently cross over, go under, or are parallel to rail ROW, requiring extensive coordination between the entities responsible for the highway and the railroad or rail transit lines, including safety considerations. FHWA's Railway-Highway Crossings Program 2 provides funds for safety improvements to reduce the number of fatalities, injuries, and crashes at public railway-highway grade crossings.

    2http://safety.fhwa.dot.gov/xings/.

    On June 5, 2008, a congressional hearing before the Subcommittee on Railroads, Pipelines, and Hazardous Materials, within the House Committee on Transportation and Infrastructure, included testimonies by the ACHP, the Alaska Railroad Corporation, the National Conference of State Historic Preservation Officers (“NCSHPO”), the National Trust for Historic Preservation (“NTHP”), the North Carolina Department of Transportation, and the Rails-to-Trails Conservancy.3 The purpose of the hearing was to consider whether federal requirements for the preservation of historic properties created unnecessary delays and administrative burdens for improvements to rail infrastructure. This hearing revealed that while the nation's railroad system is historically important, the existing federal review process in some cases could be carried out more efficiently to expedite project delivery. As a result, Congress mandated a study to explore these issues and to recommend solutions.

    3The Historic Preservation of Railroad Property and Facilities: Hearing before the Subcommittee on Railroads, Pipelines, and Hazardous Materials of the Committee on Transportation and Infrastructure House of Representatives, 110th Congress, 2008.

    Pursuant to Section 407 of the Passenger Rail Investment and Improvement Act of 2008 (“PRIIA”), FRA, in partnership with other USDOT OAs, state departments of transportation (“state DOTs”), and historic preservation organizations and agencies, including the ACHP, NCSHPO, and NTHP, conducted a study assessing the current state of historic preservation for federally funded railroad projects and the potential for expediting compliance with Section 106 and Section 4(f) (23 U.S.C. 138, 49 U.S.C. 303). In 2013, FRA submitted to Congress the resulting study, titled “Streamlining Compliance with Section 4(f) of the Department of Transportation Act and Section 106 of the National Historic Preservation Act for Federally Funded Railroad Infrastructure and Improvement Projects” (“2013 FRA Study”).4

    4Report to Congress: Streamlining Compliance with the Section 4(f) of the Department of Transportation Act and Section 106 of the National Historic Preservation Act for Federally Funded Railroad Infrastructure Repair and Improvement Projects, Federal Railroad Administration, March 2013, https://www.fra.dot.gov/eLib/details/L04483.

    The 2013 FRA Study drew upon the experiences shared by the participating agencies and organizations, SHPOs, and other stakeholders, and on best practices and data extrapolated from case studies. The 2013 FRA Study concluded that there is no consistent approach on how to address the National Register eligibility of railroad corridors or how to avoid, minimize, or mitigate impacts to individual rail properties along a corridor once it is determined to be eligible for the National Register. The lack of consistency was attributed to a multitude of entities conducting National Register evaluations, including SHPOs, Tribal Historic Preservation Officers (“THPOs”), federal agencies, consultants, state DOTs and railroad and rail transit operators. These inconsistency issues raised concerns regarding the lack of specific nationwide guidance for identifying, evaluating, and classifying rail properties and differentiation based on likely importance of particular historic resources on the part of each evaluator. This variety of approaches leads to inconsistent standards for evaluation and procedures to consider and address impacts, an overly burdensome process, delays in project delivery, and some projects failing to advance. The substantial experience of USDOT OAs over the years in funding maintenance, improvements, and upgrades to railroads and rail transit systems, and highway/rail grade crossings, has provided further evidence of this conclusion. Furthermore, the experience of USDOT OAs has been that undertakings involving maintenance, improvements, and upgrades to rail infrastructure often do not result in adverse effects to historic properties under Section 106 when early planning involves diverse stakeholders.

    The 2013 FRA Study offered several streamlining recommendations, including the development of a Section 106 administrative exemption and a program comment. In 2015, Congress mandated a proposed administrative exemption in the FAST Act and directed USDOT that the exemption be consistent with the Interstate Highway Exemption. Developed by FHWA and approved by the ACHP in 2005, the Section 106 exemption for the Interstate Highway System acknowledges “the importance of the Interstate System in American history, but also recognizes that ongoing maintenance, improvements and upgrades are necessary to allow the system to continue to serve the transportation needs of the nation.” 5 Further, the concept for the exemption for the Interstate Highway System stated that, “While actions carried out by federal agencies to maintain or improve the Interstate System will, over time, alter various segments of the system, such changes are considered to be `minimal or not adverse' when viewing the system as a whole. Moreover, the exemption does not apply to certain historically important elements of the system.” Therefore, in exempting only certain effects of undertakings to the interstate highway system, the exemption met the requirements of 36 CFR 800.14(c)(1).

    5Exemption Regarding Historic Preservation Review Process for Effects to the Interstate Highway System, 70 FR 11928, Mar. 10, 2005.

    In accordance with Section 11504 of the FAST Act, the USDOT, led by FRA and FTA, proposed to the ACHP in July 2017 a Section 106 exemption that would have applied to certain types of undertakings within rail ROW that would result in effects to rail properties that were likely to be minimal or not adverse. FRA's and FTA's proposed exemption drew upon the collective expertise and experience of the USDOT OAs and acknowledged the unique history, construction, and technological improvements of railroads and rail transit systems. The exemption as initially drafted also included an optional Project Sponsor-led property-based approach that could have streamlined the review process for other types of undertakings having the potential to adversely affect historic properties.

    To develop the proposed exemption, FRA and FTA held early coordination meetings with the ACHP, NCSHPO, and NTHP. The purpose of these meetings was to discuss the most effective approach to an exemption that would satisfy the FAST Act requirement. It was also identified during these meetings that more information on the history of rail transit development in the country was needed to have comparable information to what was contained in FRA's 2013 Study. Subsequently, in 2017 FTA prepared a broad historic context report entitled, “Historic Context Report for Transit Rail System Development.” 6 Also during the early coordination meetings, the ACHP, NCSHPO, and USDOT acknowledged that opportunities for stakeholder outreach would be provided to obtain input from railroad and rail transit industries, state agencies (e.g., state DOTs), SHPOs and THPOs, Indian tribes and Native Hawaiian organizations, and historic preservation interest groups.

    6https://www.transit.dot.gov/regulations-and-guidance/environmental-programs/historic-context-report-transit-rail-system.

    FRA's and FTA's original approach to the proposed exemption was to treat the ROW in which railroads and rail transit systems operate as a resource unto itself that would be exempt from Section 106 review. FRA and FTA conducted outreach to discuss and seek feedback from stakeholders regarding how such a property-based approach might be developed and implemented. The ACHP expressed concern that a property-based approach would exceed the limit of its authority to exempt activities under 54 U.S.C. 304108(c) and 36 CFR 800.14(c)(1) because it did not define the program or category of undertakings that would be subject to its terms and as proposed, it could allow adverse effects to historic properties without requiring Section 106 review. The ACHP recommended that FRA and FTA take an activities-based approach to the Section 106 exemption that focused on routine undertakings involving rail properties located within rail ROW, with effects that would be foreseeable and likely to be minimal or not adverse. This recommendation was echoed in comments submitted to FRA and FTA by numerous stakeholders, particularly from the preservation community. The ACHP also recommended FRA and FTA consider developing a separate program comment to provide for the property-based approach along a parallel track.

    Subsequently, in response to the concerns and requests of Project Sponsors, particularly transportation stakeholders, that the program alternative should include the flexibility to address a broader range of undertakings and effects to historic properties, FRA, FTA, and the ACHP decided to incorporate the proposed activities-based exemption within a proposed program comment in order to restore the two-part concept within a single program alternative, including the property-based approach, as originally proposed by FRA and FTA. The proposed program comment recognizes that many properties in the national railroad network and rail transit systems have historic significance and that important historic rail properties (as defined in the draft program comment, Section VI: Definition of Terms) located within rail ROW should remain subject to Section 106 review when proposed undertakings cannot avoid adverse effects on such properties.

    The proposed program comment is intended to balance the need for continued safe and efficient transportation with the goals of historic preservation, and takes into account the differences between the Interstate Highway System and railroad and rail transit operations. Each railroad and rail transit system has its own unique history of construction and operation, including private or public ownership; periods of economic success; opening of key markets or geographic areas; and improvements, acquisition, and consolidation or abandonment. Many buildings and structures within rail ROW followed the common standard plans of a specific carrier, but there were exceptions for individual buildings, bridges, and other structures that may have unique qualities or unusual design characteristics. Similarly, many rail corridors follow a simple natural grade and alignment, but there were exceptions made for difficult terrain, climate, and topography that may have involved unique or unusual engineering techniques and structures. Railroads have been adapted to accommodate modern freight, passenger train operations, higher speeds, and much heavier freight loads than those for which the original rail infrastructure was designed and built. Finally, rail ROW is typically privately-owned, making it challenging or impossible to perform the cultural resources surveys usually necessary to develop a comprehensive inventory of rail properties.

    The nation's rail ROW and rail properties located therein have a long history, dating to the mid-1800s, and maintenance, improvements, and upgrades are necessary to their preservation and continued safe use. These activities have occurred and continue to occur regularly within rail ROW to maintain the efficient use and safety of the nation's railroads, rail transit systems, and roads; and support the continued function for which surface transportation is historically important.

    II. Program Comment Concept

    The continued operation of railroads and rail transit systems is vital to enabling the efficient and safe movement of people and goods throughout America. Various linear segments of rail lines, as well as individual buildings and structures along those rail lines, were determined eligible for and/or listed on the National Register prior to Congress's mandate to develop a Section 106 exemption for rail ROW.

    A primary objective of the proposed program comment is to expedite certain types of maintenance, improvements, and upgrades to railroad and rail transit infrastructure located within rail ROW that typically have not resulted in adverse effects to historic properties based on years of experience gained through the Section 106 consultations among USDOT OAs, SHPOs, and consulting parties for individual undertakings. Under such an approach, fewer routine undertakings involving rail properties would be subject to Section 106 review thereby enabling federal agencies to focus their time and resources on undertakings that have the potential to cause adverse effects on historic properties. Federal agency staff, Project Sponsors, SHPOs, THPOs, and other stakeholders would be able to devote more time and resources to developing solutions that avoid, minimize, or resolve adverse effects to important historic rail properties and non-rail historic properties located within an undertaking's Area of Potential Effects (“APE”).

    Recognizing the concerns and needs of industry stakeholders and seeking to achieve further efficiencies in project reviews, the ACHP, FRA and FTA incorporated the originally proposed exemption into a different program alternative under 36 CFR 800.14: a program comment. Unlike an exemption, which the ACHP can only approve for undertakings that have effects to historic properties that are foreseeable and likely to be minimal or not adverse, a program comment may provide an optional alternative process for compliance with Section 106 for a category of undertakings, including those that may result in adverse effects. Therefore, the proposed program comment includes both an activities-based exemption and an optional Project Sponsor-led approach to identify important historic rail properties and streamline the review process for other transportation-related activities. It is important to note that this Project Sponsor-led approach would require an investment of time and resources and would not likely result in immediate efficiencies as would the approval of the list of exempted activities under Appendix A. To ensure the requirements of the FAST Act are met, the program comment would incorporate the substance of the exemption for certain activities within rail ROW, as well as add the property-based approach as envisioned by FRA and FTA and discussed during the agencies' outreach to stakeholders in late 2016 and early 2017.

    Given the unique history of the rail industry and the challenge of conducting the cultural resources surveys that would be needed to develop a comprehensive nationwide inventory of rail properties (including restrictions regarding access to privately-owned rail ROW, the extensive linear miles of rail ROW nationwide, and the number of qualified professionals and financial resources that would be needed), it is not feasible for USDOT OAs or Project Sponsors to identify all important historic rail properties nationwide concurrently with the development of this program alternative. The program comment would include a modified review process for transportation-related undertakings that would only apply after completion of the optional Project Sponsor-led approach to identify important historic rail properties within a study area.

    Under the program comment, Project Sponsors, in coordination with the appropriate USDOT OA(s), the ACHP, NCSHPO, individual SHPOs/THPOs, NTHP, railroad and rail transit operators, state DOTs, and other appropriate stakeholders, would have the option to follow an established process to develop a list of important historic rail properties within a designated study area. The Project Sponsor would ensure that the public would be given an opportunity to provide input on the proposed list of such properties. The appropriate USDOT OA(s), in consultation with Project Sponsors, the ACHP, SHPOs/THPOs, and other stakeholders, would confirm the significance and integrity of these important historic rail properties consistent with National Register criteria.

    The intent of this optional Project Sponsor-led identification and evaluation effort would be to (1) revisit those rail properties that have been previously determined eligible for listing or listed on the National Register to confirm that the property meets one or more of the National Register eligibility criteria, retains integrity, and is considered important (as defined in Section VI, Definitions of Terms), and (2) identify previously unevaluated rail properties located within the study area that should be recognized as important historic rail properties. Once the identification process is complete, federal agencies would be able to carry out, license, permit, or assist transportation-related undertakings that meet the terms listed in the Program Comment without further Section 106 review.

    Project Sponsors could benefit from this optional property-based approach because it would expedite Section 106 reviews for non-routine undertakings through the early identification of and agreement on important historic rail properties located in rail ROW. The upfront identification of such properties would allow Project Sponsors to plan for and design projects within rail ROW in a manner that could avoid or minimize effects to such important properties. Furthermore, if a Project Sponsor completes the process to identify important historic rail properties, another review efficiency would apply. Future transportation-related activities within the same study area that require a license, permit, or assistance from any federal agency and that would affect rail properties that are not included on a USDOT OA-approved list of important historic rail properties would not be subject to further Section 106 review.

    The lead federal agency for a proposed transportation-related undertaking in rail ROW will be responsible for determining if the program comment applies. Approval by the lead federal agency would be required in the form of written approval or through another established review and decision-making process normally used by the lead federal agency (e.g., grant-making processes or permit issuance).

    III. Public Participation

    In accordance with 36 CFR 800.14(e)(2), USDOT, in coordination with the ACHP, is arranging for public participation appropriate to the subject matter and scope of the category of undertakings to be included within this program comment. This notice invites the public to comment on the proposed draft program comment.

    In addition to this notice, FRA and FTA have previously solicited the views of a diverse group of stakeholders and subject matter experts. While that outreach was conducted with the intent to develop a Section 106 exemption (as defined in 36 CFR 800.14(c)), the substance of FRA's and FTA's original proposal is essentially the same as the content of the draft program comment that is being made available for public review and comment in this notice. This outreach included in-person meetings, webinars followed up with attendees' submittal of written comments and questions, teleconferences, and presentations at national transportation conferences with representatives from the following: USDOT OAs, the ACHP, NCSHPO, the National Association of Tribal Historic Preservation Officers, NTHP, tribal governments, individual SHPOs and their staff, THPOs, and state DOTs; national transportation associations (e.g., AAR, American Public Transportation Association); private railroad companies; intercity passenger rail service providers (e.g., Amtrak) and rail transit agencies; the Surface Transportation Board (STB); 7 and historic preservation organizations (e.g., American Cultural Resources Association). These agencies and organizations shared their unique and varied perspectives and concerns and provided valuable feedback. Prior to transitioning the approach from an exemption to a program comment and when proposing to request an exemption, in response to the ACHP's recommendation to satisfy its consultation responsibilities under 36 CFR 800.14(c)(3), FRA and FTA provided a draft exemption to all SHPOs and THPOs for review and requested their feedback regarding any significant issues. Pursuant to 36 CFR 800.14(c)(4), the ACHP shared a draft of the proposed exemption with Indian tribes and Native Hawaiian organizations and hosted two conference calls to solicit their input and feedback. Comments were received from nine SHPOs and 14 tribes in October 2017. FRA and FTA considered these comments and made further revisions to the draft of the proposed exemption primarily to clarify the scope of the proposed exemption to make it clear that the focus was strictly on rail properties and would not apply to other types of historic properties that could be located within or adjacent to rail ROW. FRA and FTA also refined some of the proposed exempted activities in Appendix A in response to comments from SHPOs and Indian tribes, but did not eliminate any activities from the draft list because the agencies felt that all stakeholders should have the opportunity to review and provide comments. The draft exemption shared with SHPOs, THPOs, Indian tribes, and Native Hawaiian organizations in September and October 2017 focused only on exempted activities and did not include the optional Project Sponsor-led approach for identifying important historic rail properties.

    7 The Surface Transportation Board (STB) is an independent agency that has broad economic regulatory oversight of the nation's freight rail system and jurisdiction over railroad rate and service issues; new rail line constructions; abandonments of existing rail lines; and railroad mergers and line acquisitions. Refer to STB's Web site at https://www.stb.gov/stb/about/overview.html.

    The feedback received over the past year has been helpful in informing the development of the proposed program alternative and generally related to the following topics: (1) The scope, applicability, and implementation of exempt activities; (2) how important historic rail properties could be identified; (3) what types of resources, including archaeological sites, should explicitly not be covered by the program alternative; and (4) developing and clarifying the definitions of terms used in the proposed exemption. FRA and FTA used this feedback to refine the proposed list of exempt activities included in Appendix A and to revise key definitions (such as the definition of rail ROW). As FRA and FTA refined the approach to and scope of the proposed exemption based on stakeholder input, they determined that certain actions, such as those approved by STB (e.g., rail line abandonments, new rail line constructions) as well as conversion of rail ROW to shared use (e.g., bicycle, pedestrian) trails (sometimes referred to as “rails-to-trails” initiatives), have the potential to cause adverse effects or greater than minimal effects on historic properties, and therefore are not appropriate for inclusion in the proposed list of exempt activities included in Appendix A. The fundamental purpose of the proposed exempted activities list is to enable federal agencies to expedite reviews and approvals of proposed transportation-related undertakings for certain types of maintenance, improvements, and upgrades to railroad and rail transit infrastructure; accordingly, FRA and FTA expect that these activities would primarily involve extant buildings, structures, and equipment in existing rail ROW. Therefore, and in consideration of stakeholder comments received to date, FRA and FTA determined that effects to archaeological resources of any nature, including those associated with railroads and rail transit, should not be covered by the proposed exemption. Lastly, in response to feedback from NCSHPO and several individual SHPOs, the draft program comment includes an annual reporting requirement to help assess the effectiveness of Section 106 review streamlining as well as to help ensure that the program comment's terms are being appropriately applied.

    In addition to providing substantive comments regarding the scope and content of the proposed exemption, some SHPOs questioned the type of Section 106 program alternative itself. The FAST Act specifically mandates development of an exemption; however, after further consideration and in order to fulfill the intent of that statutory mandate, USDOT and the ACHP have revised the exemption to this draft program comment. The program comment would have a broader scope and include more types of undertakings than would have the exemption.

    IV. Proposed Text of the Program Comment

    The following is the draft text of the proposed program comment:

    Program Comment To Exempt Effects of Transportation-Related Undertakings Within Rail Rights-of-Way

    Section 106 of the National Historic Preservation Act (“NHPA”), 54 U.S.C. 306108 (“Section 106”), requires federal agencies to “take into account” the effects of their undertakings on historic properties and to provide the Advisory Council on Historic Preservation (ACHP) a reasonable opportunity to comment with regard to such undertakings. The ACHP has issued regulations that set forth the process through which federal agencies comply with these duties. Those regulations are codified under 36 CFR part 800 (“Section 106 regulations”).

    Under section 800.14(e) of those regulations, agencies can request the ACHP to provide a “program comment” on a particular category of undertakings in lieu of conducting separate reviews of each individual undertaking under such category, as set forth in 36 CFR 800.3 through 800.7. Federal agencies can meet their Section 106 responsibilities with regard to the effects of transportation-related undertakings on rail properties located in railroad and rail transit rights-of-way (“rail ROW”) by following this program comment and the steps set forth therein.

    I. Introduction

    This program comment exempts from Section 106 review the activities listed in Appendix A provided the conditions specified therein are met. It also establishes an optional Project Sponsor-led property-based approach. This optional approach could be followed to identify important historic rail properties in rail ROW in advance of specific transportation-related undertakings. Undertakings affecting such important historic rail properties and that involve activities not included in Appendix A would remain subject to Section 106 review, in order to ensure potential adverse effects are avoided, minimized, or mitigated. However, the optional property-based approach, described in Section IV below, if completed by an interested Project Sponsor, would also create efficiencies by (1) allowing transportation-related undertakings proposed to be carried out, licensed, permitted, or assisted by any federal agency to proceed without Section 106 review if the affected rail property(ies) is not on the USDOT OA-approved list of important historic rail properties and (2) providing Project Sponsors with an early awareness of which rail properties are important so that they could design projects in a manner to either avoid adverse effects or to factor sufficient time into project planning and design to resolve any unavoidable adverse effects.

    The proposed program alternative has been developed in accordance with section 11504 of the FAST Act (49 U.S.C. 24202). Section 11504 mandated the development of a Section 106 exemption for “railroad rights-of-way.” More specifically, it required the Secretary of Transportation to submit a proposed exemption to the ACHP for consideration, and for the ACHP to issue a final exemption not later than 180 days after the date of receipt of U.S. Department of Transportation's (“USDOT's”) submittal.

    Pursuant to 36 CFR 800.14(e), the ACHP can issue a program comment on its own initiative or at the request of another agency. This program comment would provide the ACHP's comment on those transportation-related undertakings that may affect rail properties within rail ROW. If a federal agency responsible for carrying out, licensing, permitting, or assisting such an undertaking with the potential to affect rail-related historic properties meets the terms of this program comment, its Section 106 responsibility to take into accounts those effects would be satisfied.

    Under 36 CFR 800.14(c), an exemption from Section 106 for federal undertakings must be consistent with the purposes of the NHPA. Furthermore, in order to be exempted, the potential effects of those undertakings on historic properties must be “foreseeable and likely to be minimal or not adverse.” The substance of USDOT's originally proposed exemption, incorporated within this program comment, meets these criteria. The transportation-related undertakings that federal agencies carry out, license, permit, and assist to maintain, improve, or upgrade rail properties located within rail ROW will alter over time various elements of rail ROW, but such changes are minimal or not adverse when viewing rail ROW as a whole and when limited to the activities specified in Appendix A.

    II. Applicability

    The program comment would apply to (1) those undertakings that are strictly limited to the activities listed in Appendix A and are carried out, licensed, permitted, or assisted by any federal agency and involve rail properties located within existing rail ROW; and (2) any transportation-related undertaking that would be carried out, licensed, permitted, or assisted by any federal agency and meets the terms for the completed optional Project-Sponsor led approach to identify important historic rail properties. The activities listed in Appendix A are for the intended purpose of routine maintenance, improvements, and upgrades to transportation infrastructure. Should the Program Comment be issued by the ACHP, federal agencies would be able to proceed with carrying out, licensing, permitting, or assisting undertakings that are limited to the activities listed in Appendix A and that meet the certain conditions specified therein without further Section 106 review regardless of whether the rail properties involved or affected are eligible for or listed on the National Register. Undertakings involving activities that are not included in Appendix A would not be included within the proposed exemption section of the program comment (e.g., demolition; decommissioning, abandonment and/or conversion of rail infrastructure to a non-transportation use; double-tracking a historically single-tracked rail corridor; major new construction activities such as construction of a new or substantially expanded passenger station; or construction of a new railroad or rail transit line on new right-of-way (commonly referred to as “greenfield construction”)). However, some of these activities may fall within the other section of the program comment regarding the optional Project Sponsor-led property-based approach.

    Activities requiring a federal license, permit, or assistance that are not listed in Appendix A but constitute a transportation-related undertaking with the potential to affect rail properties located within rail ROW, as defined in Section VI, Definitions of Terms, would not require Section 106 review provided the optional Project Sponsor-led approach for identifying important historic rail properties has been completed for a defined study area and the affected rail property(ies) within that study area are not included on a USDOT OA-approved list of important historic rail properties.

    If the optional Project Sponsor-led approach to identify important historic rail properties has been completed for a defined study area, transportation-related undertakings involving activities that are not included in Appendix A and would affect properties included on a USDOT OA-approved list of important historic rail would require Section 106 review. This would ensure that potential adverse effects to important historic rail properties are appropriately avoided, minimized, or mitigated consistent with the purposes of the NHPA.

    Federal agencies remain responsible for determining whether a proposed undertaking, including those activities listed in Appendix A, has the potential to cause effects to non-rail historic properties, such as those of religious and cultural significance to Indian tribes or Native Hawaiian organizations or archaeological sites of any nature, in the undertaking's APE. If a federal agency determines such potential exists, the federal agency must follow the requirements of 36 CFR part 800 or follow an applicable program alternative executed pursuant to 36 CFR 800.14 in order to consider the potential effects to such properties located within that APE.

    Under the Surface Transportation Project Delivery Program, codified at 23 U.S.C. 327, a state may assume the Secretary of Transportation's responsibilities to comply with Section 106 for certain projects or classes of projects. In such cases, the state may rely on this program comment to fulfill its Section 106 responsibilities. Where a program alternative developed pursuant to 36 CFR 800.14, such as a statewide programmatic agreement, delegates Section 106 responsibility to another entity, that entity may also utilize the terms of this program comment for relevant transportation-related undertakings.

    III. Activities Exempt From Section 106 Review

    Undertakings that are carried out by a federal agency or require a federal license, permit, or assistance to maintain, improve, or upgrade rail properties located in railroad and rail transit rights-of-way (“rail ROW”) and are limited to the activities specified in Appendix A: Exempted Activities, are exempt from the requirements of Section 106 of the National Historic Preservation Act, 54 U.S.C. 306108 (“Section 106”) because their effects on rail historic properties are foreseeable and likely to be minimal or not adverse.

    IV. Optional Project Sponsor-Led Property-Based Approach

    If a Project Sponsor wishes to carry out a transportation-related activity that requires a federal license, permit, or assistance and is not included in Appendix A and therefore has the potential to cause adverse effects to historic rail properties, it must either: (1) Notify the lead federal agency, which will then determine whether the standard Section 106 process or an available program alternative applies to the proposed undertaking; or (2) follow the Project-Sponsor led approach outlined in this section to identify important historic rail properties. Important historic rail properties, as defined further in Section VI, are individual rail properties or rail property types that meet the National Register eligibility criteria (36 CFR part 63), illustrate the history of the development of the nation's railroads or rail transit systems, and either possess national significance or are of certain state or local importance.

    Given the variety and number of rail properties nationwide, the fact that many systems cross state boundaries, and the challenges of a “one size fits all” nationwide approach, important historic rail properties would be initially identified within defined study areas by Project Sponsors that wish to get additional benefit from this program comment beyond the list of exempted activities included in Appendix A. The process would intentionally provide a great deal of flexibility for Project Sponsors to identify important historic rail properties to meet state and local needs and interests and to take into account state and local historic contexts. Within six months of the ACHP's issuance of the final Program Comment, FRA, FTA, and FHWA, in coordination with the ACHP, and other federal agencies who may have an interest in utilizing the Program Comment (e.g., permitting agencies such as US Army Corps of Engineers or US Coast Guard), will develop supplemental guidance for implementing the optional Project Sponsor-led property-based approach described below to identify important historic rail properties.

    A. Process for Identifying Important Historic Rail Properties

    1. Individual Project Sponsors or multiple Project Sponsors working collaboratively must clearly identify the study area to be subject to this process: The portion of rail ROW (i.e., by location (state, county); name of rail corridor, railroad, rail transit system or line; mile-post information; etc.). Project Sponsors must propose to the appropriate USDOT OA(s) (i.e., FRA, FTA and/or FHWA), rail properties to be included on a list of important historic rail properties. To develop such a list, Project Sponsors will consult with the appropriate USDOT OA(s), appropriate State Historic Preservation Officers (“SHPOs”), appropriate Tribal Historic Preservation Officers (“THPOs”), and other interested parties, i.e. those parties that would typically be involved in the standard Section 106 process to identify historic properties as specified in 36 CFR 800.4(a)-(c), that have knowledge and expertise regarding rail properties and of the history and operations of the nation's railroads and rail transit systems. The proposed list of important historic rail properties may include particular individual properties (i.e., a building, structure, object, or district) or a property type (e.g., bridges of a certain type (stone arch, metal truss, covered, or moveable); roundhouses). The Project Sponsor's efforts to develop a list of important historic rail properties will be informed by available background research, historic context studies, surveys and evaluations performed by persons meeting the Secretary of the Interior's Professional Qualification Standards for Architectural Historians, and other relevant documentation and professional experience and expertise.

    2. Once a Project Sponsor proposes a list of important rail properties located within a study area, the Project Sponsor will coordinate with the appropriate USDOT OA(s) to determine an appropriate method(s) for seeking public input on the proposed list and to determine which entity(ies) will be responsible for implementing the agreed-upon public outreach strategy. The Project Sponsor and/or the USDOT OA(s), as appropriate, will then implement the agreed-upon strategy. The USDOT OA(s) will consider input from interested parties and the public before approving the list of important historic rail properties.

    3. The USDOT OAs make the final decision regarding the list of important historic rail properties within each study area, and will publish all finalized lists on their respective agency Web sites (www.fra.dot.gov, www.fta.dot.gov, or www.fhwa.dot.gov). The relevant USDOT OA will update the list anytime a Project Sponsor completes the process described herein to identify important historic rail properties located within another study area.

    4. Once approved by the appropriate USDOT OA(s), the list of important historic rail properties will be available for use by any Project Sponsor and any federal agency.

    B. No Further Section 106 Review Required

    Should any of the exempted activities in Appendix A referred to in Section III be proposed and affect important historic rail properties included on a USDOT OA-approved list, no further Section 106 review would be required for those activities.

    For rail properties in a given study area that are not included on a USDOT OA-approved list of important historic rail properties, the effects of transportation-related undertakings to those rail properties would be exempt from Section 106 review.

    V. Continued Applicability of Section 106

    Section 106 review is still required for transportation-related undertakings within rail ROW in the following situations under both the activities-based exemption and Project Sponsor-led property-based approach:

    A. Undertakings that are located within, or would affect historic properties located on tribal lands;

    B. Undertakings, within a study area that has completed the optional Project Sponsor-led approach that involve activities that are not included in Appendix A and would affect important historic rail properties

    C. Undertakings that could affect historic buildings, structures, sites, objects, or districts that do not have a demonstrable association with the function and operation of a railroad or rail transit system;

    D. Undertakings that could affect archaeological sites located within, partially within, or bisected by rail ROW, regardless of whether the sites are associated with railroads or rail transit systems; 8 and

    8 Examples include: Archaeological remains of non-extant rail properties that have been determined eligible for the National Register under Criterion D or warrant evaluation for such eligibility because they may yield data and information on the development and operation of railroads and rail transit systems in U.S. history; archaeological sites that represent worker camps associated with the construction of a railroad and have been determined eligible for the National Register under Criterion A or warrant evaluation for such eligibility; prehistoric or historic archaeological sites that pre-date construction of a railroad or rail transit line and are historically significant for reasons that do not have a nexus with rail transportation.

    E. Undertakings that could affect historic properties of religious and cultural significance to federally recognized Indian tribes or Native Hawaiian organizations.

    In addition, federal agencies remain responsible for determining whether a proposed undertaking has the potential to cause effects to non-rail above-ground historic properties (buildings, structures, objects and districts) and archaeological sites of any nature (regardless of a rail nexus) that are located in the undertaking's area of potential effects (“APE”) but outside of or adjacent to rail ROW under both the activities-based exemption and Project Sponsor-led property-based approach.

    Likewise, if an unanticipated discovery of a non-rail historic property, archaeological site, or human remains is made during implementation of an exempt activity listed in Appendix A, the Project Sponsor must cease the activity and consult with the lead federal agency, who must follow the requirements of 36 CFR 800.13(b) and/or applicable state burial law with regard to the discovery; if an undertaking involves multiple exempted activities, those that do not involve or effect the discovery may continue.

    VI. Definition of Terms

    A. Area of potential effects, as defined in 36 CFR 800.16(d), means the geographic area or areas within which an undertaking may directly or indirectly cause alterations in the character or use of historic properties, if any such properties exist. The area of potential effects is influenced by the scale and nature of an undertaking and may be different for different kinds of effects caused by the undertaking.

    B. Historic properties, as defined in 36 CFR 800.16(l), means any prehistoric or historic district, site, building, structure, or object included in, or eligible for inclusion in, the National Register of Historic Places maintained by the Secretary of the Interior. This term includes artifacts, records and remains that are related to and located within such properties. The term includes properties of religious and cultural importance to a federally recognized Indian tribe or Native Hawaiian organization that meet the National Register criteria.

    C. Important historic rail properties means rail properties located in rail ROW that have been identified through the Project-Sponsor led approach established in Section IV. Such properties must meet the National Register eligibility criteria (36 CFR part 63), illustrate the history of the development of the nation's railroads or rail transit systems, and either possess national significance (see the definition below) or be of certain state or local importance. Examples of properties of certain state or local importance may include extant architectural properties, such as passenger depots, roundhouses, bridges, and tunnels that are not included in common standard plans; that met unique engineering challenges; that have exceptional design quality and characteristics; or that are of unusual or noteworthy importance, or are a rare property type.

    D. National significance means a historic property that is either, (1) designated as a National Historic Landmark; (2) designated as a Civil Engineering Landmark; (3) listed as nationally significant in its nomination or listing in the National Register; or (4) determined to have significance at the national level.9

    9 Properties that have previously been determined to be nationally significant may be re-evaluated as part of the optional Project Sponsor-led approach. Properties may be newly determined to be nationally significant as part of the consultation that would occur under the optional Project Sponsor-led approach.

    E. Project Sponsor means an entity such as a state, tribal or local government, joint venture, or private company that is eligible to receive financial assistance under a federal transportation-related financial assistance program (e.g., grant, loan). A project sponsor may also be an entity that requires a federal permit, license, or approval in order to carry out a proposed activity in rail ROW (e.g., a permit under Section 404 of the Clean Water Act issued by the Army Corps of Engineers or a permit under Section 9 of the Rivers and Harbors Act of 1899 issued by the United States Coast Guard).

    F. Rail properties means, for the purpose of this program comment, infrastructure within the rail ROW that has a demonstrable relationship to the past or current function and operation of a railroad or rail transit system, including but not limited to: Rails and tracks, ties, ballast, rail beds, signal and communication systems, switches, overhead catenary systems, signage, traction power substations, passenger stations/depots and associated infrastructure and utilities, freight transfer facilities, boarding areas and platforms, boarding platform shelters and canopies, bridges, culverts, tunnels, retaining walls, ancillary facilities, ventilation structures, equipment maintenance and storage facilities, railyards, parking lots and structures, landscaping, passenger walkways, and security and safety fencing. The definition does not include properties with no demonstrable relationship to the function and operation of a railroad or rail transit system, such as: Adjacent residential, commercial or municipal buildings; archaeological resources underneath rail ROW that are unrelated to the railroad or rail transit line; or property unrelated to existing or former railroads and rail transit lines that is proposed to be used for new rail infrastructure.

    G. Railroad and Rail Transit Rights-of-Way (rail ROW) means, for the purpose of this program comment, the land and infrastructure that have been developed for existing or former intercity passenger rail, freight rail, or rail transit operations, or that are maintained for the purpose of such operations. Rail ROW includes current or former railroad or rail transit lines regardless of current ownership and whether there is rail service operating on the railroad or rail transit line. It does not include land that was never developed and lacks visual evidence of historic railroad or rail transit use. Rail ROW includes and may be identifiable by the presence of infrastructure that has a demonstrable relationship to the past or current function and operation of a railroad or rail transit system that commonly includes but is not limited to the rail properties specified in the definition above.

    H. Section 106 means Section 106 of the National Historic Preservation Act, 54 U.S.C. 306108, and its implementing regulations, 36 CFR part 800.

    I. Undertaking, as defined at 36 CFR 800.16(y), means a project, activity, or program funded in whole or in part under the direct or indirect jurisdiction of a federal agency, including those carried out by or on behalf of a federal agency; those carried out with federal financial assistance; and those requiring a federal permit, license or approval.

    VII. Effective Date

    This program comment shall go into effect on the date it is issued by the ACHP, at which time federal agencies may immediately utilize the list of exempted activities in Appendix A, including undertakings that have not yet been initiated and undertakings for which the Section 106 review process is underway but not completed.

    VIII. Reporting

    Any lead federal agency that utilizes this program comment shall report annually to NCSHPO, NATHPO, and the ACHP regarding the application of the exempt activities in Appendix A. The USDOT OAs will also report annually to NCSHPO, NATHPO, and the ACHP regarding any coordination with Project Sponsors to pursue the property-based approach.

    XIV. Amendment

    The Chairman of the ACHP may amend this program comment after consulting with the USDOT and other relevant federal agencies, NCSHPO, NATHPO, tribal representatives, the National Trust for Historic Preservation, and industry representatives, as appropriate. The ACHP will publish a notice in the Federal Register informing the public of any amendments that are made to the program comment.

    XV. Sunset Clause

    This program comment will expire twenty (20) years from the date of its issuance, unless it is amended prior to that date to extend the period in which it is in effect.

    XVI. Withdrawal

    The Chairman of the ACHP may withdraw this program comment, pursuant to 36 CFR 800.14(e)(6), by publication of a notice in the Federal Register 30 days before the withdrawal will take effect.

    Appendix A: Exempted Activities

    Undertakings limited to the activities listed below and when occurring within rail ROW are exempt from Section 106 review because their effects on rail-related historic properties are foreseeable and likely to be minimal and not adverse.

    The lead federal agency for a proposed transportation-related undertaking in rail ROW is responsible for determining if the program comment applies. Approval by the lead federal agency of undertakings involving exempt activities specified below will be required in the form of written approval or through another established review and decision-making process normally used by the lead federal agency (e.g., grant-making processes or permit issuance). In particular, activities denoted with (*) and (**) require evaluation by professionals meeting the Secretary of the Interior's (“SOI”) Professional Qualification Standards for Archaeologists or Architectural Historians, as appropriate. If the appropriate SOI-qualified professionals are not available to assist in the design and evaluation of activities denoted with (*) and (**), such activities are not exempt and remain subject to Section 106 review. Additional information regarding activities denoted with (*), (**) and (***) is provided following the list.

    Before approving an undertaking, the lead federal agency (or a Project Sponsor that has been delegated or assigned responsibility for Section 106 compliance) must determine if the undertaking has the potential to cause effects to non-rail historic properties located within or in the vicinity of the rail ROW. For example, the construction of a new equipment maintenance building in an existing rail yard could introduce a visual, atmospheric, vibratory, and/or audible element that could affect nearby non-rail historic properties. If such potential exists, the lead federal agency (or a Project Sponsor that has been delegated or assigned Section 106 responsibility) must follow the requirements of 36 CFR part 800, including establishing an Area of Potential Effects (APE) as defined in 36 CFR 800.16(d), or an applicable program alternative executed pursuant to 36 CFR 800.14 in order to consider the potential effects to non-rail historic properties located within that APE. This requires the federal agency and/or Project Sponsor to complete the four-step Section 106 review process for such non-rail historic properties in the APE: Initiating the process; identifying historic properties; assessing adverse effects; and resolution of adverse effects to historic properties. Nevertheless, the effects of the activities listed below on rail properties within rail ROW remain exempt from Section 106 review.

    If an unanticipated discovery of a non-rail historic property, archaeological site of any nature, or human remains is made during the implementation of an exempt activity, the Section 106 requirements at 36 CFR 800.13 and/or state burial law, as appropriate depending on the nature of the discovery, would apply because such resources are not covered by the program comment. In addition, although the activities listed below are exempted from Section 106, the Project Sponsor must still comply with the requirements of any easements, covenants, or state or local historic designations applicable to the affected rail property(ies). At minimum, the Project Sponsor must cease all work in and secure the area of the discovery while the appropriate notifications are made and the parties consult to determine the appropriate course of action.

    A. Track and Trackbed 10

    10 These activities do not include alterations to the trackbed that would result in a substation visual change (i.e., elevation) in the relationship between the trackbed and the surrounding landscape.

    1. Replacement of rails, fasteners, ties, or bridge timbers. This includes replacing jointed rail with continuous welded rail. This does not include changing the gauge of the rail.

    2. Addition of switches in an existing trackbed.

    3. Replacement of Y-tracks, turn-outs, frogs, or switches within existing footprint.

    4. Installation of new turn-outs, sidings, and crossovers in areas of previously disturbed soils or when construction methods do not require surface removal (*).

    5. Replacement of subgrade, ballast, and sub-ballast materials.

    6. Addition of fill free of debris or other clean borrow materials on top of existing soils or fill.

    7. Excavation of clean borrow material from sources within the rail ROW (*).

    8. Scraping and undercutting of an existing subgrade or embankment to restore a horizontal profile or increase vertical clearance (*). This includes modifying the subgrade only, not modifications to bridges, tunnels, or other infrastructure.

    9. Widening an existing embankment for the addition of turn-outs (*).

    10. Reinstallation of track in the same location where it existed previously but had been removed (e.g., reinstallation of double tracking on a currently single-tracked line that had historically been double-tracked).

    11. Removal of abandoned sidings, rails, ties, or ballast.

    B. Bridges and Tunnels

    1. The following bridge and tunnel structure maintenance actions: Cleaning; in-kind painting of the bridge superstructure or substructure; in-kind masonry repointing; deck overlay with the same or similar materials as existing; application of preservative and corrosion protection treatments; ballast cribbing; affixing stiffeners; or patching spalled concrete.11

    11 “In-kind” as used here and elsewhere in Appendix A means that new materials used in repairs or replacements must match the material being replaced in composition, design, color, texture, and other visual and material properties. Substitute materials should be used only on a limited basis and only when they will match the appearance and general properties of the historic material and will not damage the historic property. For more information, see https://www.nps.gov/tps/standards/rehabilitation/rehab/stand.htm.

    2. Repair or replacement of brackets, hardware, angles, rivets, flanges, bearings, fasteners, motors, locking devices, or similar elements.

    3. In-kind repair or replacement of structural or non-structural bridge members (e.g., I-beams, T-beams, girders, box beams, abutments, piers, parapets, bents, bridge protective systems (e.g., fenders, pile clusters, dolphins, sheer booms, sheer fences, island protection systems, or floating protection systems)) that do not alter character-defining features of the bridge (**). This does not include full or partial demolition of a bridge.

    4. Actions to strengthen or address deteriorating structural conditions of bridges that are intended to preserve their useful life and that do not alter character—defining features of the bridge (**). Examples include converting the bridge deck from an open deck to a ballast deck; the replacement of traditional roller bearing assemblies to elastomeric or similar pad bearings; or changing the material beneath the ballast such that the change in material would not be visually discernable from outside of the ROW.

    5. Repair or replacement of tunnel ventilation structures and associated equipment (e.g., fans, ducting) (**). Replaced structures must be substantially the same size as or smaller than existing and be visually compatible with the surrounding built environment.

    6. Removal or replacement of any bridge or tunnel material or added-on element that is not part of the original construction or that was not added during a period of major alteration dating back to 45 years or earlier (**).

    C. Rail Buildings (i.e., Passenger Stations and Depots, Maintenance and Equipment Buildings, Interlocking Towers, Signal Houses)

    1. In-kind repair or replacement of light fixtures in public spaces, such as passenger waiting areas.

    2. Repair, extensions to the width, or extension or shortening of the length of boarding platforms, as necessary to meet federally-mandated ADA-compliant boarding requirements or to accommodate longer or shorter trains, that are constructed with common concrete methods (e.g., concrete slab) (*). This does not include platforms constructed with brick, stone, tile, wood, or other materials. This does not include platform modifications that would result in the need to modify paths of travel, such as through the installation of ramps, to achieve ADA compliant access to/from associated passenger stations.

    3. In-kind repair of platforms constructed with brick, stone, tile, wood, or other non-concrete materials (**). This does not include increasing the height of an existing platform to meet ADA requirements.

    4. Maintenance, repair, or replacement (**) of escalators and elevators.

    5. Cleaning, painting, or refinishing of surfaces with a like color and where the products or methods used would not damage the original surface.

    6. In-kind masonry repointing.

    7. Repair or replacement of passenger walkways constructed with common concrete or asphalt methods when consistent with existing materials.

    8. The following federally mandated ADA improvements at passenger stations do not damage, cover, alter, or remove character-defining architectural spaces, features, or finishes:

    a. Installation or replacement (**) of the following: Restroom stalls/partitions, and hardware and fixtures such as grab bars, tilt frame mirrors, sinks, and toilets; tactile warning strips on floors, passenger walkways, and platforms; cane detectors; sidewalk curb cuts; automatic door openers; station identifier and wayfinding signage; public information display systems (PIDS); wheelchair lifts; and wheelchair lift enclosures. This does not include ADA improvements involving the installation, modification, or removal of ramps, stairs, doors, windows, roofs, platform boarding canopies and supports, or ticket counters.

    b. Widening of or adjustments to the slope of passenger walkways constructed with common concrete or asphalt methods (*).

    9. Interior maintenance work or alterations in stations or other railroad facilities that is limited to non-public spaces that lack architectural distinction (**).

    10. Replacement of pumps, air compressors, or fueling stations (*).

    11. Removal of mechanical equipment inside railroad facilities not visible to the public (***). Examples include relay panels, switchgear, and track diagram boards.

    12. Addition of new mechanical equipment in basements, beneath platforms, in designated mechanical equipment areas, or in areas that are otherwise out of public view.

    13. Paving, painting, or striping of parking surfaces.

    14. In-kind repair and replacement of platform boarding canopies and supports (*,**).

    15. State-of-good-repair (“SOGR”) activities (**) not otherwise on this list that are necessary to keep a station, depot, or other rail building inhabitable, safe,12 and in use, and may affect character-defining architectural features of the property, such as the repair or in-kind replacement of the following: Elevator head houses and portals; roofs; doors; windows; stairs; or railings. SOGR activities do not include demolition, decommissioning, or mothballing of rail buildings that are not in use, or reconfiguring the interior spaces of passenger stations for a new use (e.g., enclosing a passenger waiting area to create new office, baggage handling, or event space).

    12 As required by applicable federal or municipal fire, life safety, or health codes or standards.

    D. Signals, Communications, and Power Generation

    1. Maintenance, repair, or replacement of component parts of signal, communications, catenary, electric power systems, or other mechanical equipment that retains the visual appearance of the existing infrastructure (**). This includes replacement of individual signal masts, but does not include wholesale removal or replacement of a catenary system or signal bridge.

    2. Maintenance, repair, or replacement (*) of radio base stations.

    3. Maintenance, repair, or replacement (*) of the mechanical components of traction power substations, i.e., transformers, circuit breakers, electrical switches. This does not include replacement of an entire substation.

    4. Maintenance or repair of signal instrument houses and signal bungalows (**).

    5. Installation, repair, or replacement of communications equipment on locomotives and rolling stock that are actively used for intercity passenger rail, rail transit, or freight rail. This does not apply to historic trains used for tourism.

    E. Rail/Roadway At-Grade Crossings and Grade Separations

    1. Maintenance of existing at-grade railroad crossings including installation of railroad crossing signs, signals, gates, warning devices and signage, highway traffic signal preemption, road markings, and similar safety upgrades (*).

    2. In-kind repair, rehabilitation, or replacement of existing at-grade railroad crossings including installation of railroad crossing signs, signals, gates, warning devices and signage, highway traffic signal preemption, road markings, and similar safety upgrades (*,**).

    3. Installation of new, at-grade railroad crossings on existing railroads and roadways, including installation of railroad crossing signs, signals, gates, warning devices and signage, highway traffic signal pre-emption, road markings, and similar safety features (*). This does not apply when the crossing involves an individual National Register-listed or eligible roadway or a roadway that is a contributing resource to a National Register-listed or eligible historic district.

    4. Expansion of existing sidewalks, constructed with common concrete or asphalt methods, along the sides of an existing at-grade rail crossing (*).

    5. Maintenance, repair, or rehabilitation of existing grade-separated crossings of other transportation modes (highways, local roads, pedestrian underpasses) (*,**). This does not include modifications to existing grade separation structures (e.g., bridges, overpasses) that would result in a substantial increase in height or overall massing.

    6. Addition of lanes, turning lanes, road widening, and pavement markings for at-grade crossings (*). This does not apply when the crossing involves an individual National Register-listed or eligible roadway or a roadway that is a contributing resource to a National Register-listed or eligible historic district.

    7. Construction of curbs, gutters, or sidewalks adjacent to existing roadway for at-grade crossings (*). This does not apply when the crossing involves an individual National Register-listed or eligible roadway or a roadway that is a contributing resource to a National Register-listed or eligible historic district.

    F. Safety

    1. Repair, replacement, or installation of the following security and intrusion prevention devices (*,**): security cameras, closed captioned television (CCTV) systems, light poles and fixtures, bollards, emergency call boxes, access card readers, and warning signage.

    2. Replacement of security and safety fencing where the replacement is substantially the same appearance as existing (*). This does not include replacement of an open-fence design with a closed design that would create a visual barrier.

    3. Replacement or installation of safety equipment/fall protection equipment on rail bridges, signal bridges, or other non-station structures for the protection of rail workers or the public (**). Examples include railings, walkways, gates, tie-off safety cables, anchors, or warning signage.

    4. Repair, replacement, or installation of wayside detection devices (*).

    5. Repair, replacement (*), or installation (*,**) of bridge clearance/strike beams.

    G. Erosion Control, Rock Slopes, and Drainage

    1. Placement of rip rap to prevent erosion affecting bridges and waterways.

    2. Erosion control through slide and slope corrections (*).

    3. Rock removal and re-stabilization activities such as scaling and bolting.

    4. Maintenance, repair, or replacement (*) of pre-cast concrete, cast iron, and corrugated metal culverts that lack stone headwalls. This does not include uniquely constructed culverts such as those built by the Civilian Conservation Corps or those made out of unusual materials (e.g., a hollowed log).

    5. Expansion, through horizontal elongation, of pre-cast concrete, cast iron, and corrugated metal culverts that lack stone headwalls for the purpose of improved drainage (*).

    6. Embankment stabilization or the re-establishment of ditch profiles where no new grading is involved.

    7. Corrections to drainage slopes, ditches, and pipes to alleviate improper drainage or changing alluvial patterns (*).

    8. In-kind repair or replacement of retaining walls (*,**).

    9. Maintenance, repair, or alterations to the interiors of culverts and related drainage pathways.

    H. Environmental Abatement

    1. Removal of environmental hazards on bridge structures, e.g., treated wood that may leak into waterways or sensitive habitat, removal of graffiti; and abatement of lead/heavy-metal coatings and paintings. Activities that replace coatings or paint must be of the same color and appearance as the materials that have been abated.

    2. Removal of asbestos-containing pipe insulation or transmitter relay panels in or on rail operations buildings, bridges, or tunnels.

    3. Removal of contaminated ballast and sub-ballast materials.

    4. Removal of contaminated soils (*).

    I. Operations

    1. Establishment of quiet zones, including the installation of required warning devices and additional safety measures installed at grade crossings, that do not entail closing of existing roadways.13

    13 A quiet zone is an FRA exemption to the rule requiring trains to sound their horns when approaching public highway‐rail grade crossings. More information on the creation of quiet zones is available in FRA's regulations at 49 CFR part 222, Use of Locomotive Horns at Public Highway-Rail Grade Crossings, and in guidance promulgated by FRA's Office of Railroad Safety (for example, see https://www.fra.dot.gov/Page/P0841 and https://www.fra.dot.gov/eLib/Details/L04781).

    2. Increased frequency of train operations that do not result in noise or vibration impacts. (Note: A noise and vibration study would be prepared by a qualified subject matter expert as part of the NEPA process).

    3. Temporary storage of rail cars on active rail lines.

    4. Repair, maintenance, or replacement (*) of noise barriers. Replacements must be substantially the same size and visual appearance as existing.

    J. Landscaping, Access Roads, and Laydown Areas

    1. In-kind replacement of existing landscaping.

    2. Mowing, seeding/reseeding, planting, tree trimming, brush removal, or other similar groundcover maintenance activities.

    3. Herbicidal spraying.

    4. Maintenance of existing access roads and lay-down areas (*).

    K. Utilities

    1. Installation, maintenance, repair, relocation, or replacement of underground utilities (*). Examples include electrical, sewer, compressed air lines, fuel lines, and fiberoptic cable.

    2. Maintenance, repair, or replacement (*) of above-ground utilities. Replacements must be substantially the same size and scale (including height) as existing.

    3. Installation, maintenance, repair, or replacement of utility lines and conduit inside tunnels that does not involve affixing new equipment to the exterior face of tunnel portals.

    4. Affixing conduit, repeaters, antennae, and similar small-scale equipment on the exterior masonry face of tunnel portals where the color of the equipment matches the existing masonry in order to limit its visibility and does not damage the masonry construction (**).

    L. Bicycle and Pedestrian Facilities, Shared Use Paths, and Other Trails

    1. Maintenance, repair, or replacement (*) of existing bicycle lanes, pedestrian walkways, shared use paths (e.g., bicycle, pedestrian), and other trails intended for non-motorized transportation that are constructed with common materials.

    2. Adding lanes to existing shared use paths or other trails constructed with common materials (*).

    3. Adding crossings for pedestrians and bicycle facilities, shared use paths, or other trails (*).

    4. Installation of bicycle aid stations, bicycle racks and storage units, and similar amenities (*, **).

    5. Maintenance, repair, or replacement (*) of bicycle aid stations, bicycle racks, and storage units, and similar amenities. Replacements must be substantially the same size and appearance as existing.

    6. Installation of information kiosks, panels, and similar amenities for pedestrian, bicyclists, or other path or trail users (***).

    7. Maintenance, repair, or replacement (*) of information kiosks, panels, and similar amenities. Replacements must be substantially the same size and appearance as existing.

    8. Maintenance, repair, or replacement (*) of existing curbs, gutters, or sidewalks constructed with common materials (e.g., non-decorative concrete or asphalt).

    M. Construction/Installation of New Rail Infrastructure

    1. Minor new construction and installation of rail infrastructure that is compatible with the scale, size, and type of existing rail infrastructure, such as buildings for housing telecommunications equipment, signal instruments, and similar equipment; storage buildings that house landscaping or maintenance of way equipment or specialty vehicles for track repairs or inspections; locomotive and train car service and inspection (S&I) facilities; trailers or temporary structures for housing rail personnel; and safety/security fencing that uses an open design and does not create a visual barrier. (*,**) applies to all activities in this bullet. This does not include the construction of new passenger stations, rail yards, bridges, or tunnels, or demolition of existing structures.

    2. Installation of utility and communications poles, transmission lines, and related equipment within electrified rail ROW (i.e., rail ROW with existing overhead transmission lines) (*). New poles and overhead lines must be substantially the same height as existing. (Note: If another existing Section 106 Program Alternative, such as the ACHP Program Comment for Positive Train Control or the ACHP Program Comment for Wireless Communications Facilities, would apply to the proposed activities, defer to that Program Alternative.)

    3. Installation of new culverts beneath the trackbed in areas not visible or accessible to the public (*).

    N. Rail Properties Less Than 45 Years Old

    1. Maintenance, repair, replacement, rehabilitation, or demolition of any rail property less than 45 years old is an exempt activity (unless the rail property is of exceptional importance as defined under NHRP Criterion Consideration G 14 and as determined through consultation between the lead federal agency and the State Historic Preservation Officer (SHPO)). However, as with all other activities in this list, the Project Sponsor and lead federal agency must consider whether the activity may cause effects to adjacent or nearby non-rail historic properties (e.g., demolition of a tall rail building could alter the existing viewshed or eliminate a noise buffer). Depending on the nature of the proposed undertaking, such consideration of effects to non-rail properties may require the involvement of an SOI-qualified professional and consultation with SHPO and other consulting parties, as well as establishment of an APE and identification of historic properties in that APE, assessment of effects to those properties, and resolution of any adverse effects to those properties.

    14 For information regarding the NRHP Criteria for Evaluation, see https://www.nps.gov/nr/publications/bulletins/nrb15/.

    (*) The proposed undertaking must be located entirely within previously disturbed soils or fill. Previously disturbed soils are those that show visible evidence that construction techniques used during previous construction activities required the grading or removal of soil or the addition of fill. A project engineer may be able to determine whether the ground has been previously disturbed or the project location consists of fill based on a review of relevant engineering plans from earlier construction activities at that location. If it cannot be readily demonstrated from a review of available documentation or a non-intrusive site investigation that the entire vertical and horizontal limits of ground disturbance for a proposed undertaking would be entirely located within previously disturbed soils or fill, the lead federal agency (or a Project Sponsor that has been delegated or assigned responsibility for Section 106 compliance) must ensure a Secretary of the Interior (SOI)-qualified archeologist confirms the presence or absence of previously disturbed soils. The Project Sponsor, if it has not been delegated or assigned responsibility for Section 106 compliance, must submit to the lead federal agency the archaeologist's recommendation, with supporting justification, that the undertaking would only affect disturbed soils, and the lead federal agency must provide written concurrence to the Project Sponsor before the undertaking can proceed. If the archaeologist determines that undisturbed soils are present in areas of proposed ground disturbance or if there is uncertainty, this program comment does not apply and the proposed activity remains subject to standard Section 106 review or another applicable program alternative.

    (**) The proposed undertaking must meet one of the following circumstances:

    • The affected rail property(ies) is listed on the National Register of Historic Places (NRHP), has previously been determined eligible for listing on the NRHP, or the lead federal agency and Project Sponsor agree to treat the affected rail property(ies) as eligible for listing on the NRHP based on factors such as the date of construction (generally 45 years old or older) and the establishment of the period(s) of significance, an assessment of integrity, and the identification of character-defining features of the affected rail property(ies) by an SOI-qualified professional. SOI-qualified professionals may be federal agency staff, federal agency contractors, Project Sponsor staff, and/or consultants hired by Project Sponsors. The value of treating a rail property as being historic is the time-savings achieved by not having to go through the full identification, evaluation, and consultation steps of the standard Section 106 process. When the affected rail property(ies) is considered historic, the work must be performed in accordance with SOI standards. The work must follow the National Park Service Standards for Preservation and Guidelines for Preserving Historic Buildings, as appropriate. Whenever possible, historic fabric must be repaired rather than replaced. The Project Sponsor, if it has not been delegated or assigned responsibility for Section 106 compliance, must provide written justification to the lead federal agency explaining why repair is not feasible. In cases where existing historic materials are beyond repair, replacement must be carried out in-kind. The lead federal agency must ensure the Project Sponsor is performing the work using or under the direct supervision of an SOI-qualified professional in the relevant discipline(s). Verification and approval in writing by the lead federal agency is required before the Project Sponsor can implement the proposed undertaking. Lastly, the lead federal agency must notify the relevant SHPO(s) in writing of the proposed undertaking upon the lead federal agency's approval and prior to the Project Sponsor's commencement of the undertaking. Or,

    • The rail property is less than 45 years old and does not meet NHRP Criterion Consideration G. In such cases, the Project Sponsor may carry out maintenance, repair, rehabilitation, or replacement activities of any nature and does not need to follow SOI standards with regard to the subject rail property. However, the restrictions noted in Section N of the preceding list apply.

    (***) If the equipment to be removed includes obsolete or outdated technology, the Project Sponsor must contact the relevant SHPO, railroad museums or railroad historical societies, museums, educational institutions, or similar entities to determine if there is an entity that may be interested in purchasing or receiving the equipment as a donation, as appropriate. The Project Sponsor, if it has not been delegated or assigned responsibility for Section 106 compliance, must demonstrate to the lead federal agency that it has made a good faith effort to contact such parties prior to removal and disposition of such equipment.

    Authority:

    36 CFR 800.14(e).

    Dated: November 14, 2017. Kelly Y. Fanizzo, Associate General Counsel.
    [FR Doc. 2017-25025 Filed 11-16-17; 8:45 am] BILLING CODE 4310-K6-P
    DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [Docket ID FEMA-2014-0022] Technical Mapping Advisory Council AGENCY:

    Federal Emergency Management Agency, DHS

    ACTION:

    Committee Management; Notice of Federal Advisory Committee Meeting.

    SUMMARY:

    The Federal Emergency Management Agency (FEMA) Technical Mapping Advisory Council (TMAC) will meet via conference call on December 6, 2017. The meeting will be open to the public.

    DATES:

    The TMAC will meet via conference call on Wednesday, December 6, 2017 from 10:30 a.m. to 5:30 p.m. Eastern Standard Time (EST). Please note that the meeting will close early if the TMAC has completed its business.

    ADDRESSES:

    For information on how to access the conference call, information on services for individuals with disabilities, or to request special assistance for the meeting, contact the person listed in FOR FURTHER INFORMATION CONTACT below as soon as possible. Members of the public who wish to dial in for the meeting must register in advance by sending an email to [email protected] (attention Mark Crowell) by 11 a.m. EST on Friday, December 1, 2017.

    To facilitate public participation, members of the public are invited to provide written comments on the issues to be considered by the TMAC, as listed in the SUPPLEMENTARY INFORMATION section below. The Agenda and other associated material will be available for review at www.fema.gov/TMAC by Friday, December 1, 2017. Written comments to be considered by the committee at the time of the meeting must be received by Monday, December 4, 2017, identified by Docket ID FEMA-2014-0022, and submitted by one of the following methods:

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

    Email: Address the email TO: [email protected] and CC: [email protected] Include the docket number in the subject line of the message. Include name and contact detail in the body of the email.

    Mail: Regulatory Affairs Division, Office of Chief Counsel, FEMA, 500 C Street SW., Room 8NE, Washington, DC 20472-3100.

    Instructions: All submissions received must include the words “Federal Emergency Management Agency” and the docket number for this action. Comments received will be posted without alteration at http://www.regulations.gov, including any personal information provided. Docket: For docket access to read background documents or comments received by the TMAC, go to http://www.regulations.gov and search for the Docket ID FEMA-2014-0022.

    A public comment period will be held on December 6, 2017, from 1:30-1:50 p.m. EST. Speakers are requested to limit their comments to no more than two minutes. Please note that the public comment periods may end before the time indicated, following the last call for comments. Contact Mark Crowell, below, to register as a speaker by close of business on Friday, December 1, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Mark Crowell, Designated Federal Officer for the TMAC, FEMA, 500 C Street SW., Washington, DC 20472-3100, telephone (202) 646-3432, and email [email protected] The TMAC Web site is: http://www.fema.gov/TMAC.

    SUPPLEMENTARY INFORMATION:

    Notice of this meeting is given under the Federal Advisory Committee Act, 5 U.S.C. Appendix.

    As required by the Biggert-Waters Flood Insurance Reform Act of 2012, the TMAC makes recommendations to the FEMA Administrator on: (1) How to improve, in a cost-effective manner, the (a) accuracy, general quality, ease of use, and distribution and dissemination of flood insurance rate maps and risk data; and (b) performance metrics and milestones required to effectively and efficiently map flood risk areas in the United States; (2) mapping standards and guidelines for (a) flood insurance rate maps, and (b) data accuracy, data quality, data currency, and data eligibility; (3) how to maintain, on an ongoing basis, flood insurance rate maps and flood risk identification; (4) procedures for delegating mapping activities to State and local mapping partners; and (5) (a) methods for improving interagency and intergovernmental coordination on flood mapping and flood risk determination, and (b) a funding strategy to leverage and coordinate budgets and expenditures across Federal agencies. Furthermore, the TMAC is required to submit an Annual Report to the FEMA Administrator that contains: (1) A description of the activities of the Council; (2) an evaluation of the status and performance of flood insurance rate maps and mapping activities to revise and update Flood Insurance Rate Maps; and (3) a summary of recommendations made by the Council to the FEMA Administrator.

    Agenda: On December 6, 2017, the TMAC will review the final narrative content for the TMAC 2017 Annual Report and conduct a vote on the final content and, if approved, submit the report including the previously approved 2017 recommendations and implementation actions to the FEMA Administrator. Members of the public will be afforded an opportunity to comment (no more than 2 minutes per individual) prior to any votes taken by the TMAC. A more detailed agenda will be posted by November 30, 2017, at http://www.fema.gov/TMAC.

    Dated: November 3, 2017. Roy E. Wright, Deputy Associate Administrator for Insurance and Mitigation, Federal Emergency Management Agency.
    [FR Doc. 2017-24969 Filed 11-16-17; 8:45 am] BILLING CODE 9110-12-P
    DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [Docket ID: FEMA-2017-0034; OMB No. 1660-0015] Agency Information Collection Activities: Proposed Collection; Comment Request; Revisions to National Flood Insurance Program Maps: Application Forms and Instructions for (C)LOMAs and (C)LOMR-Fs AGENCY:

    Federal Emergency Management Agency, DHS.

    ACTION:

    Notice and request for comments.

    SUMMARY:

    The Federal Emergency Management Agency, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public to take this opportunity to comment on a reinstatement, without change, of a previously approved information collection for which approval has expired. In accordance with the Paperwork Reduction Act of 1995, this notice seeks comments concerning information required by the Federal Emergency Management Agency to amend or revise National Flood Insurance Program maps to remove certain property from the 1-percent annual chance floodplain.

    DATES:

    Comments must be submitted on or before January 16, 2018.

    ADDRESSES:

    To avoid duplicate submissions to the docket, please use only one of the following means to submit comments:

    (1) Online. Submit comments at www.regulations.gov under Docket ID FEMA-2017-0034. Follow the instructions for submitting comments.

    (2) Mail. Submit written comments to Docket Manager, Office of Chief Counsel, DHS/FEMA, 500 C Street SW., 8NE, Washington, DC 20472-3100.

    All submissions received must include the agency name and Docket ID. Regardless of the method used for submitting comments or material, all submissions will be posted, without change, to the Federal eRulemaking Portal at http://www.regulations.gov, and will include any personal information you provide. Therefore, submitting this information makes it public. You may wish to read the Privacy Act notice that is available via the link in the footer of www.regulations.gov.

    FOR FURTHER INFORMATION CONTACT:

    Todd Steiner, Program Analyst, FEMA, Federal Insurance & Mitigation Administration, at (202) 679-4061 or [email protected] You may contact the Records Management Division for copies of the proposed collection of information at email address: [email protected]

    SUPPLEMENTARY INFORMATION:

    The National Flood Insurance Program (NFIP) is authorized by the National Flood Insurance Act of 1968, as amended, 42 U.S.C. 4001 et seq. The Federal Emergency Management Agency (FEMA) administers the NFIP and maintains the maps that depict flood hazard information. The land area covered by the floodwaters of the base flood is the Special Flood Hazard Area (SFHA) on NFIP maps. The SFHA is the area where the NFIP's floodplain management regulations must be enforced and the area where the mandatory purchase of flood insurance applies. If a SFHA has been determined to exist for property and the owner or lessee of the property believes his/her property has been incorrectly included in a SFHA, information can be provided to support removal of the SFHA designation. NFIP regulations, at 44 CFR parts 65 and 70, outline the data that must be submitted by an owner or lessee of property who believes his/her property has been incorrectly included in a SFHA. In order to remove an area from a SFHA, the owner or lessee of the property must submit scientific or technical data demonstrating that the area is “reasonably safe from flooding” and not in the SFHA.

    This information collection expired on September 30, 2017. FEMA is requesting a reinstatement, without change, of a previously approved information collection for which approval has expired.

    Collection of Information

    Title: Revisions to National Flood Insurance Program Maps: Application Forms and Instructions for (C)LOMAs and (C)LOMR-Fs.

    Type of information collection: Reinstatement, without change, of a previously approved information collection for which approval has expired.

    OMB Number: 1660-0015.

    Form Titles and Numbers: FEMA Form 086-0-26, Property Information; FEMA Form 086-0-26A, Elevation Form; FEMA Form 086-0-26B, Community Acknowledgement Form; FEMA Form 086-0-22 and FEMA Form 086-0-22A (Spanish), Application Form for Single Residential Lot or Structure Amendments to National Flood Insurance Program Maps.

    Abstract: FEMA collects scientific and technical data submissions to determine whether a specific, single-lot property is located within or outside of a Special Flood Hazard Area (SFHA). If the property is determined not to be within a SFHA, FEMA provides a written determination and the appropriate map is modified by a Letter of Map Amendment (LOMA) or a Letter of Map Revision-Based on Fill (LOMR-F). The owner or lessee of a property uses a LOMA or LOMR-F to show that a property is not located within the SFHA, making it possible for the lending institution to waive the flood insurance requirement. If the policyholder decides to maintain insurance on the property, the new determination should result in lower rates.

    Affected Public: Individuals and Households; and Business or Other for-Profit Institutes.

    Estimated Number of Respondents: 121,116.

    Estimated Number of Responses: 121,116.

    Estimated Total Annual Burden Hours: 150,725 hours.

    Estimated Total Annual Respondent Cost: $6,501,379.

    Estimated Respondents' Operation and Maintenance Costs: $24,099,750.

    Estimated Respondents' Capital and Start-Up Costs: $0.

    Estimated Total Annual Cost to the Federal Government: $268,401.

    Comments

    Comments may be submitted as indicated in the ADDRESSES caption above. Comments are solicited to (a) evaluate whether the proposed data collection is necessary for the proper performance of the agency, including whether the information shall have practical utility; (b) evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) enhance the quality, utility, and clarity of the information to be collected; and (d) minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

    Tammi Hines, Acting Records Management Program Chief, Mission Support, Federal Emergency Management Agency, Department of Homeland Security.
    [FR Doc. 2017-24968 Filed 11-16-17; 8:45 am] BILLING CODE 9111-52-P
    DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [Internal Agency Docket No. FEMA-3394-EM; Docket ID FEMA-2017-0001] Alabama; Amendment No. 1 to Notice of an Emergency Declaration AGENCY:

    Federal Emergency Management Agency, DHS.

    ACTION:

    Notice.

    SUMMARY:

    This notice amends the notice of an emergency declaration for the State of Alabama (FEMA-3394-EM), dated October 8, 2017, and related determinations.

    DATES:

    This amendment was issued October 26, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-2833.

    SUPPLEMENTARY INFORMATION:

    Notice is hereby given that the incident period for this emergency is closed effective October 10, 2017.

    The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050 Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant. Brock Long, Administrator, Federal Emergency Management Agency.
    [FR Doc. 2017-24970 Filed 11-16-17; 8:45 am] BILLING CODE 9111-23-P
    DEPARTMENT OF HOMELAND SECURITY Transportation Security Administration [Docket No. TSA-2011-0008] Aviation Security Advisory Committee (ASAC) Meeting AGENCY:

    Transportation Security Administration, DHS.

    ACTION:

    Committee Management; Notice of Federal Advisory Committee Meeting.

    SUMMARY:

    The Transportation Security Administration (TSA) will hold a meeting of the Aviation Security Advisory Committee (ASAC) on Thursday, December 7, 2017, to discuss issues listed in the “Meeting Agenda” section below. This meeting will be open to the public as stated in the Summary section below.

    DATES:

    The Committee will meet on Thursday, December 7, 2017, from 9:00 a.m. to 12:00 p.m. This meeting may end early if all business is completed.

    ADDRESSES:

    The meeting will be held at TSA Headquarters, 601 12th Street South, Arlington, VA 20598-6028.

    FOR FURTHER INFORMATION CONTACT:

    Dean Walter, Aviation Security Advisory Committee Designated Federal Official, Transportation Security Administration (TSA-28), 601 South 12th Street, Arlington, VA 20598-6028, [email protected], 571-227-2645.

    SUPPLEMENTARY INFORMATION: Summary

    Notice of this meeting is given in accordance with the Aviation Security Stakeholder Participation Act, codified at 49 U.S.C. 44946. Pursuant to 49 U.S.C. 44946(f), ASAC is exempt from the Federal Advisory Committee Act (5 U.S.C. App.). The committee provides advice and recommendations for improving aviation security measures to the Administrator of TSA.

    The meeting will be open to the public and will focus on items listed in the “Meeting Agenda” section below. Members of the public, and all non-ASAC members and non-TSA staff must register in advance with their full name and date of birth to attend. Due to space constraints, the meeting is limited to 75 people, including ASAC members and staff, on a first to register basis. Attendees are required to present government-issued photo identification to verify identity.

    In addition, members of the public must make advance arrangements, as stated below, to present oral or written statements specifically addressing issues pertaining to the items listed in the “Meeting Agenda” section below. The public comment period will begin at approximately 11:00 a.m., depending on the meeting progress. Speakers are requested to limit their comments to three minutes. Contact the person listed in the FOR FURTHER INFORMATION CONTACT section no later than November 30, 2017, to register to attend the meeting and/or to present oral or written statements addressing issues pertaining to the items listed in the “Meeting Agenda” section below. Anyone in need of assistance or a reasonable accommodation for the meeting should contact the person listed in the FOR FURTHER INFORMATION CONTACT section.

    Meeting Agenda

    The Committee will meet to discuss items listed in the agenda below:

    • Committee recommendations update • Subcommittee briefings on calendar year (CY) 2017 activities, key issues, and areas of focus for CY 2018: ○ Commercial airports ○ International aviation ○ Air cargo ○ General aviation ○ Security Technology • Legislative Update • REAL ID Act of 2005 implementation update • Discussion of the CY 2018 Committee Agenda Dated: November 9, 2017. Eddie D. Mayenschein, Assistant Administrator, Office of Security Policy and Industry Engagement.
    [FR Doc. 2017-24917 Filed 11-16-17; 8:45 am] BILLING CODE 9110-05-P
    DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR-6067-N-01] Revocation of Orders of Succession for the Office of the Deputy Secretary AGENCY:

    Office of the Deputy Secretary, HUD.

    ACTION:

    Revocation of Orders of Succession.

    SUMMARY:

    In this document, the Deputy Secretary of the Department of Housing and Urban Development rescinds all previous Orders of Succession for the Office of the Deputy Secretary.

    DATES:

    November 13, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Office of Deputy Secretary, U.S. Department of Housing and Urban Development, 451 7th Street SW., Room 10100, Washington, DC 20410-6000, telephone (202) 402-5430. (This is not a toll-free number). Persons with hearing- or speech-impairments may access this number through TTY by calling the toll-free Federal Information Relay Service at 1-800-877-8339.

    SUPPLEMENTARY INFORMATION: Section A. Revocation of Orders of Succession

    The Deputy Secretary of the Department of Housing and Urban Development revokes and rescinds any Orders of Succession for the Office of Deputy Secretary that was signed by a previous Deputy Secretary or Acting Deputy Secretary, including Orders of Succession published in the Federal Register or published by memorandum.

    Section B. Authority Superseded

    This publication supersedes all prior Orders of Succession for the Office of the Deputy Secretary, including Orders of Succession published by memorandum on January 8, 2017 and August 4, 2017.

    Authority:

    Section 7(d) of the Department of Housing and Urban Development Act, 42 U.S.C. 3535(d).

    Dated: November 13, 2017. Pamela H. Patenaude, Deputy Secretary.
    [FR Doc. 2017-25024 Filed 11-16-17; 8:45 am] BILLING CODE 4210-67-P
    DEPARTMENT OF THE INTERIOR Fish and Wildlife Service [FWS-HQ-IA-2017-N116; FXIA16710900000-XXX-FF09A30000] Issuance of Import Permits for Zimbabwe Elephant Trophies Taken on or After January 21, 2016, and on or Before December 31, 2018 AGENCY:

    Fish and Wildlife Service, Interior.

    ACTION:

    Notice.

    SUMMARY:

    The U.S. Fish and Wildlife Service (Service) has made a finding that the killing of African elephant trophy animals in Zimbabwe, on or after January 21, 2016, and on or before December 31, 2018, will enhance the survival of the African elephant. Applications to import trophies hunted during this time period will be considered to have met the enhancement requirement, unless we issue a new finding based on available information. The Service may replace this finding, without any notification in the Federal Register, at any time that this finding no longer reflects the available information consistent with the regulatory requirements. In reviewing each application received for import of such specimens, the Service evaluates the information provided in the application, as well as other information available to the Service on the status of the elephant population and the management program for elephants in the country to ensure that the program is promoting the conservation of the species. Each application to import sport-hunted elephant trophies must also meet all other applicable permitting requirements before it may be authorized. This determination does not affect previous determinations by the Service regarding trophy animals taken before January 21, 2016.

    DATES:

    This finding is made November 17, 2017.

    ADDRESSES:

    Timothy J. Van Norman, Chief, Branch of Permits, Division of Management Authority, U.S. Fish and Wildlife Service, MS: IA, 5275 Leesburg Pike, Falls Church, VA 22041-3803; fax (703) 358-2280; or email [email protected]

    FOR FURTHER INFORMATION CONTACT:

    Timothy J. Van Norman, (703) 358-2104 (telephone); (703) 358-2280 (fax); or [email protected] (email).

    SUPPLEMENTARY INFORMATION: Background

    The African elephant (Loxodonta africana) is listed as threatened under the Endangered Species Act of 1973, as amended (ESA or Act; 16 U.S.C. 1531 et seq.), on the List of Endangered and Threatened Wildlife in title 50 of the Code of Federal Regulations (50 CFR 17.11(h)). It is also regulated under the provisions of section 4(d) of the Act (known as a “section 4(d) rule”) with a rule found at 50 CFR 17.40(e). The section 4(d) rule includes specific requirements for the import of sport-hunted trophies. Under § 17.40(e)(6)(i)(B), in order for the Service to authorize the import of a sport-hunted elephant trophy, the Service must find that the killing of the trophy animal will enhance the survival of the species in the wild (known as an “enhancement finding”).

    The Zimbabwe elephant population, along with elephant populations in Botswana, Namibia, and South Africa, are also included in Appendix II of the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) for the exclusive purpose of allowing certain trade subject to annotation, including trade in hunting trophies for noncommercial purposes. All specimens not included in the annotation are deemed Appendix I specimens, and trade in them is regulated accordingly. On August 22, 1997, the U.S. Fish and Wildlife Service (Service) published a proposed rule announcing decisions by the Conference of the Parties to CITES and seeking comment on whether the United States should enter a reservation for any of the species that had been listed on CITES Appendices I and II (62 FR 44627). We discussed how the populations of African elephants in Zimbabwe, Botswana, and Namibia had been down-listed from CITES Appendix I to Appendix II and noted that, because African elephants are listed under the ESA as threatened, the African elephant section 4(d) rule found at 50 CFR 17.40(e) would continue to apply. This rule required that we find that the killing of the animal whose trophy was intended for import would enhance the survival of the species before a sport-hunted trophy could be imported. We also stated that, in making the required enhancement finding for the import of sport-hunted trophies, the Service must review the status of the elephant population and the total management program for the elephant in each country to ensure the program is promoting the conservation of the species.

    The preamble to the 1997 proposed rule noted that positive enhancement findings for the countries of Zimbabwe, Botswana, and Namibia had been made and would remain in effect until the Service found that the conditions of the section 4(d) rule are no longer met and published notice of a changed finding in the Federal Register. On May 18, 2001, we published a final rule again announcing decisions made at a meeting of the Conference of the Parties to CITES, including the decision to down-list the South African population of African elephants from CITES Appendix I to Appendix II (66 FR 27601). We again discussed the import requirements for African elephant sport-hunted trophies and stated that the enhancement finding for South African elephants would remain in effect until the Service found that conditions of the rule are no longer met and published notice of a changed finding in the Federal Register. The U.S. District Court for the District of Columbia, in Safari Club International, et al. v. Jewell, et al., 213 F. Supp. 3d 48 (D.D.C. Sept. 30, 2016), has held that the Service created a binding duty on itself when it stated in the preamble of the 1997 proposed rule that it would publish notice in the Federal Register before making a change in its 1997 enhancement finding for Zimbabwe, and that the Service then violated this commitment when it published the Federal Register notice on May 12, 2014, several weeks after making an interim negative enhancement finding for Zimbabwe on April 4, 2014. As remedy, the Court ordered that the effective date of the 2014 enhancement finding is the date of the Federal Register notice, May 12, 2014, meaning that trophies taken on or before May 11, 2014 were allowed to meet the enhancement requirement. We did not intend to create a legal duty to publish changed enhancement findings through these Federal Register preamble statements.

    On June 6, 2016, the Service amended the African elephant section 4(d) rule (81 FR 36388). With this amendment, ESA permits are required to import all African elephant sport-hunted trophies, including those from the CITES Appendix II populations of Zimbabwe, Botswana, Namibia, and South Africa. Because all imports will be accompanied by a threatened species permit evaluated through the ESA permit application process found at 50 CFR 17.32(a), we will no longer publish notice of changed enhancement findings for African elephant sport-hunted trophies in the Federal Register. In the future, when there are subsequent changes to the determination, the individual applicant will be notified regarding whether his or her permit application was granted or denied, including a brief statement of the grounds for any denial. We may also post information on the import of African elephant hunting trophies on the Service's Web page (www.fws.gov/international), as appropriate and consistent with applicable laws and regulations.

    Import Suspension

    On April 4, 2014, the Service announced an interim suspension of imports of sport-hunted elephant trophies taken in Zimbabwe during the 2014 season. We revised this finding on April 17, 2014, primarily to clarify that the suspension applied only to elephants hunted on or after April 4, 2014. This determination was announced in the Federal Register on May 12, 2014 (79 FR 26986). Our decision to establish an interim suspension of imports of elephant trophies from Zimbabwe was due to having insufficient information on the status of elephants in Zimbabwe and on Zimbabwe's current elephant management program to make an enhancement finding. On July 17, 2014, the Service found that the import of elephant trophies taken in Zimbabwe in 2014 on or after April 4, 2014, would be suspended. We revised this finding on July 22, 2014, to make non-substantive corrections and announced this determination in the Federal Register on July 31, 2014 (79 FR 44459). The July 17, 2014, decision to uphold the April 4, 2014, suspension was due to the Service being unable to make an enhancement finding even after receiving additional materials from the Zimbabwe Parks and Wildlife Management Authority (ZPWMA) and others. On March 26, 2015, the Service made another determination to continue the suspension (80 FR 42524, July 17, 2015). This decision was again due to the Service being unable to make an enhancement finding even after receiving additional materials from ZPWMA and others. The suspension that resulted from the negative enhancement findings did not prohibit U.S. hunters from traveling to Zimbabwe and participating in an elephant hunt. The Act does not prohibit take (e.g., hunting) within a foreign country; it prohibits import of trophies taken during such hunts without required authorization under the Act.

    Following the Service's March 26, 2015, finding, the Service sent a letter on May 12, 2015, to the Honorable Saviour Kasukuwere, (formerly) Zimbabwe's Minister of Environment, Water and Climate, outlining the concerns the Service still had regarding elephant trophy imports from Zimbabwe. The letter identified six areas of concern: the lack of a current management plan; the current population status of elephants in Zimbabwe; poaching levels and prevention; regulations and enforcement concerns; the sustainable utilization of elephants in Zimbabwe; and the utilization of hunting revenues.

    On July 20, 2015, ZPWMA responded to each of the questions outlined in the Service's letter and included a draft version of the Action Plan for Elephant Conservation and Management in Zimbabwe (2015-2020). In January 2016, the Service received the final version of the action plan, the Zimbabwe National Elephant Management Plan (2015-2020), that had been approved and signed by the (then) Director-General of ZPWMA Edson Chidziya, on January 20, 2016, and the Honorable Oppah Muchinguri-Kashiri, Minister of Environment, Water and Climate, on January 21, 2016.

    In September 2016, during the 17th Meeting of the Conference of the Parties to CITES, the Service met with representatives from Zimbabwe to further discuss the current status of the Service's evaluation of the importation of elephant trophies. As a result of those conversations, the Service received a letter dated November 8, 2016, with supplemental information regarding Zimbabwe's elephant management plan priorities. Further, on January 27, 2017, the Service received a letter from ZPWMA containing a report, “The Role of Trophy Hunting of Elephants in Support of the Zimbabwe's Communal Areas Management Programme for Indigenous Resources (CAMPFIRE) Program: December 2016” that more fully discussed the source and amount of revenue generated between 2010 and 2015 through the CAMPFIRE program, the current role of CAMPFIRE, and how revenue generated by elephant hunting has been utilized within communal areas over this 6-year period and into the future.

    Under 50 CFR 17.40(e)(6)(i)(B), the Service evaluates a number of factors to determine whether the killing of the trophy animal taken in a range country will enhance the survival of African elephants as well as taking into consideration the permit issuance criteria outlined in 50 CFR 17.32(a)(2). In evaluating each of these criteria, the Service has considered the information currently available to the Service as of the date of this finding on elephant hunting in Zimbabwe in 2016, 2017, and 2018, including information provided by the Government of Zimbabwe, current applicants for permits to import sport-hunted elephant trophies, interested individuals and organizations, and other information available to the Service.

    Zimbabwe's Conservation Efforts for Elephants

    On January 21, 2016, Zimbabwe adopted the Zimbabwe National Elephant Management Plan (2015-2020) (EMP) that replaced The Policy and Plan for Elephant Management in Zimbabwe (1997) and Elephant Management in Zimbabwe, third edition (July 1996), the former management plans. The EMP incorporates an adaptive management framework with higher level targets, with key components, strategic objectives, and outputs. Each key component has management actions that can be measured and verified through “Key Performance Indicators.” A set deadline for each action was identified. These measurable provisions allow ZPWMA to monitor the success of the new management plan and, through an adaptive management approach, address newly emerging concerns and long-term management needs. The EMP addresses the challenges identified by the 2014 workshop participants and concerns identified by the Service about the previous management plans. The EMP was developed as an outcome of several national and regional workshops that included government officials, nongovernmental organizations (NGOs), rural community leaders, and safari outfitters and landowners.

    The 2014 Pan African Elephant Aerial Survey, also known as the Great Elephant Census (GEC), available in 2015, provided ZPWMA with a better elephant baseline population abundance estimate to assess future hunting quotas, management efforts, and anti-poaching activities. Confirmed results from the GEC reported an estimate for elephant abundance in Zimbabwe to be 82,304 individuals (73,715-90,893). The International Union for Conservation of Nature's African Elephant Specialist Group (IUCN AfESG) African Elephant Status Report-2016 estimated Zimbabwe's elephant population at 82,630 ± 8,589 across a range of 81,228 km2. The results of the 2014 GEC, and subsequent survey data reported in the 2016 AfESG report, are more reliable and provide a better basis for establishing management priorities than previous surveys and guesses, and are now utilized in the EMP and quota setting.

    As identified in the 2015 finding, the Service explained that, if properly implemented, the ZPWMA regulatory mechanisms for managing elephants appear to be adequate. A key issue in the 2015 finding was whether an adequate mechanism is in place to reliably document the financial benefits that U.S. hunters provide for elephant conservation through participation in a hunting program that addresses management needs of the species and whether the funds were utilized in a meaningful manner. Since the 2015 finding, the Service has received information regarding the Tourism Receipts Accounting System (TRAS) and its web-based system (TRAS2) under which the Reserve Bank of Zimbabwe, in collaboration with relevant stakeholders, can now track all revenue generated through hunting activities. Under this system, all authorized hunts are now being registered, allowing for the capture of hunting data, such as the origin of clients, value of trophies and hunts, and area hunted, so that officials can monitor hunting quota utilization and track hunted trophies. This system will provide data that was not previously easily obtained and greatly improve the ability to track hunting revenue.

    One concern expressed by the Service in its previous findings was whether ZPWMA was responding to the apparent poaching crisis facing Zimbabwe. Based on communication from ZPWMA, as well as information received from other sources, ZPWMA has stepped up its anti-poaching efforts nationally by adopting a number of “Urgent Measures.” As shown in their July 2015 response to Service questions, most of ZPWMA's budget (77 percent) is allocated to staff costs and patrol provisions. These expenditures reportedly fund anti-poaching efforts throughout the elephant range. ZPWMA reportedly has a staff of 1,504 active field rangers and has stated that there is intent to increase this number. According to “The Zimbabwe National Elephant Supplementary Management Plan (2015-2020)”, provided to the Service in late 2016, over 80 percent of spending under the new EMP has been on law enforcement (anti-poaching) and training, with law enforcement identified as the top priority going forward.

    With the adoption of the EMP on January 21, 2016, it appears that ZPWMA has the means to successfully implement these laws and regulations. Moreover, ZPWMA has a mechanism in place to monitor the effects of the EMP and adapt to changing environmental and social factors that would adversely affect elephant populations within Zimbabwe.

    According to the information provided to the Service in late 2014 and 2015, Zimbabwe had established hunting quotas for all areas of the country. However, it was not until late 2015 and early 2016 that the Service received more specific information on how these quotas are established, including how other forms of take, such as poaching and problem animal control, were taken into account. Further, it was not until the EMP was signed into effect on January 21, 2016, that the Service had confidence that ZWPMA had in place effective mechanisms to ensure long-term sustainability of its elephant population.

    According to ZPWMA, quotas that were established before the EMP were set to maximize the sustainable production of high-quality trophies without detriment to the population. With the establishment of the EMP, there is a more systematic, scientific approach to establish national quotas. While ZPWMA still currently starts with an annual quota of 500 elephants, the quota is not immediately divided among all of the hunting areas. Instead, ZPWMA takes into consideration the results of the 2014 survey and subsequent surveys, results from research efforts, the size of the hunting area in relation to elephant habitat requirements, illegal harvest and other forms of take, how the hunting areas are managed in relation to land use or fencing, human-wildlife conflicts that have occurred previously, and recommended sustainable harvest levels developed based on ecological assessments of the hunting area. This information is then further evaluated in consideration of other species within the hunting area, past elephant trophy quality, and community benefits of proposed harvests.

    Since our findings in 2014 and 2015, CAMPFIRE has provided more information on how their programs support the conservation of elephants and provide benefits to and promote greater tolerance of wildlife in rural communities, including new efforts to improve the effectiveness of CAMPFIRE and new revenue-sharing guidelines. An overarching analysis of CAMPFIRE, supported by a grant of 12 million Euros from the European Union, is currently being conducted and is scheduled to be completed by the end of 2017. Although this review is still under way, more information has been provided to the Service regarding how funds are utilized and the basis for hunting quotas.

    Since our 2014 and 2015 findings, there are strong indications that the efforts of private landowners and consortiums to manage elephants within their areas of control have received greater support from ZPWMA and the Zimbabwean Government. ZPWMA has devolved authority to manage and benefit from wildlife on communal and private lands to the landholders. There now appears to be a greater effort on the part of ZPWMA to work with NGOs, landowners, and safari area concessionaires to improve elephant management and anti-poaching efforts. According to their July 2015 response to the Service, and supported by the report on the implementation of the EMP, ZPWMA is engaging private players in co-management in some areas and entering into long-term lease agreements (10-25 years) to manage some protected areas. In certain areas, ZPWMA is reportedly collaborating with safari operators; in others, they collaborate with NGOs, such as the Tashinga Initiative in the Zambezi Valley and World Wildlife Fund in the Hwange-Sanyati Biological Corridor. There is increased support from the Central Government and Rural District Councils to expand and support local conservation efforts, and there is evidence that local conservation efforts are meeting management deficiencies that the Service identified previously.

    Current Finding

    Therefore, in accordance with the regulatory requirements, the Service is able to make a determination that the killing of trophy animals in Zimbabwe, on or after January 21, 2016, and on or before December 31, 2018, will enhance the survival of the African elephant. With the information currently available, applications to import trophies hunted during this time period will be considered to have met this requirement unless we issue a new finding based on available information. In accordance with the section 4(d) rule for the African elephant at 50 CFR 17.40(e), the Service will review each application received for import of such specimens on a case-by-case basis and each application also needs to meet all other applicable permitting requirements before it may be authorized. On an ongoing basis and as it evaluates each application, the Service will continue to monitor the status of the elephant population, the management program for elephants in the country to ensure that the program is promoting the conservation of the species, and whether the participation of U.S. hunters in the program provides a clear benefit to the species. Accordingly, the Service may modify its determination based on available information consistent with the regulatory requirements. In addition, the Service will reevaluate the status of African elephants in Zimbabwe before the end of 2018 and make a new finding in the beginning of 2019 for, at least, the 2019 hunting season.

    Today's enhancement finding has been posted at http://www.fws.gov/international/pdf/enhancement-finding-2017-elephant-Zimbabwe.PDF. In addition, a list of frequently asked questions regarding the importation of sport-hunted elephant trophies from Zimbabwe is available on the Service's web page at https://www.fws.gov/international/permits/by-activity/sport-hunted-trophies-elephants.html.

    Brenda Tapia, Program Analyst/Data Administrator, Branch of Permits, Division of Management Authority.
    [FR Doc. 2017-24974 Filed 11-16-17; 8:45 am] BILLING CODE 4333-15-P
    DEPARTMENT OF THE INTERIOR Bureau of Land Management [XXX.LLAZG02000.71220000.KD0000.LVTFA0958340;AZA3116] Notice of Availability of the Draft Ray Land Exchange/Plan Amendment Supplemental Environmental Impact Statement, Arizona AGENCY:

    Bureau of Land Management, Interior.

    ACTION:

    Notice of availability.

    SUMMARY:

    In accordance with the National Environmental Policy Act of 1969 (NEPA), as amended, and the Federal Land Policy and Management Act of 1976 (FLPMA), as amended, the Bureau of Land Management (BLM), Gila District, Tucson Field Office has prepared a Draft Supplemental Environmental Impact Statement (EIS) for the Ray Land Exchange/Plan Amendment and by this Notice is announcing its availability and the opening of the comment period.

    DATES:

    To ensure comments will be considered, the BLM must receive written comments on the Ray Land Exchange/Plan Amendment Draft Supplemental EIS within 90 days following the date the Environmental Protection Agency publishes its Notice of Availability in the Federal Register. The BLM will announce future meetings or hearings and any other public involvement activities at least 15 days in advance through public notices, media releases, or mailings.

    ADDRESSES:

    You may submit comments related to the Ray Land Exchange/Plan Amendment Draft Supplemental EIS by any of the following methods:

    Web site: http://go.usa.gov/xn2FG.

    Email: [email protected].

    Fax: 602-417-9454.

    Mail: BLM Arizona State Office, Attn: Ray Land Exchange, One North Central Avenue, Suite 800, Phoenix, AZ 85004-4427.

    Copies of the Ray Land Exchange/Plan Amendment Draft Supplemental EIS are available in the BLM Arizona State Office at the above address; the BLM Tucson Field Office at 3201 East Universal Way, Tucson, AZ 85756; the BLM Kingman Field Office at 2755 Mission Boulevard, Kingman, AZ 86401; and the Kearny Public Library at 912-A Tilbury Road, Kearny, AZ 85137.

    FOR FURTHER INFORMATION CONTACT:

    Michael Werner, Project Manager, telephone 602-417-9561; address: One North Central Avenue, Suite 800, Phoenix, AZ 85004-4427; email: [email protected]

    SUPPLEMENTARY INFORMATION:

    The BLM Gila District, Tucson Field Office, is issuing the Ray Land Exchange/Plan Amendment Supplemental EIS to augment the environmental impact analysis in the Ray Land Exchange/Plan Amendment Final EIS completed by the BLM in 1999. The BLM issued the Final EIS for the Ray Land Exchange/Plan Amendment in June 1999 and the Record of Decision in May 2000. The decision approved a land exchange between ASARCO LLC (ASARCO) and the BLM for approximately 10,976 acres of public lands and federally owned mineral estate for acquisition by ASARCO (the Selected Lands) in exchange for approximately 7,304 acres of private land owned by ASARCO and identified by the BLM as desirable for improving access for hunting and other recreation (the Offered Lands). The decision was challenged administratively and in Federal court, with the plaintiffs ultimately prevailing in the Ninth Circuit Court of Appeals in November 2010. The court concluded that the BLM violated NEPA and FLPMA “in assuming without explanation that ASARCO would perform mining operations on the selected lands in the same manner regardless of the land exchange” (Center for Biological Diversity v. U.S. Department of Interior, 623 F.3d 633 [9th Cir. 2010]). The court recognized that ASARCO has the right to conduct mining and related activities under the General Mining Law, based on ASARCO's mining and mill site claims on the Selected Lands. But the court believed that the manner and extent of mining were likely to differ, depending on whether the Selected Lands are owned by the United States as public lands subject to the BLM's surface use regulations at 43 CFR 3809 or by ASARCO as private lands in fee simple, in which case the BLM's surface-use regulations would not apply. The Ninth Circuit Court stated that ASARCO is not required to prepare and submit a Mine Plan of Operations (MPO) for future activities on the Selected Lands to complete the exchange. Instead, “the BLM must make a meaningful comparison of the environmental consequences of ASARCO's likely mining operations with and without the requirement that MPOs be prepared by ASARCO and approved by the BLM—that is, with and without the proposed exchange.” Because the BLM did not perform this “with and without” comparison, the court held that the BLM did not adequately consider the environmental impacts of the land exchange or Resource Management Plan (RMP) amendments. For the same reason, the court also held that the BLM did not properly analyze whether the public interest will be served by making the exchange under FLPMA, section 206(a).

    In accordance with the courts' rulings and remand orders, the Draft Supplemental EIS for the Ray Land Exchange provides the “with and without” comparative analysis found lacking by the Ninth Circuit Court. The “with and without” analysis compares two scenarios of potential environmental impacts on the Selected Lands from mining operations. One scenario analyzes potential impacts that could occur as a result of mining activities on the Selected Lands if they are not exchanged and remain under BLM jurisdiction (i.e., mining occurs with BLM regulations). The other scenario analyzes potential impacts that could occur as a result of mining activities if the Selected Lands are exchanged and become privately owned lands (i.e., mining occurs without BLM regulations). The Draft Supplemental EIS also addresses any substantial changes in the land exchange or plan amendments and any significant new information or circumstances that are relevant to analyzing the impacts of the land exchange or plan amendments (see 40 CFR 1502.9(c); BLM NEPA Handbook, Section 5.3 [January 2008]).

    The purpose of the proposed Ray Land Exchange would be to exchange ownership of Federal lands for private lands. ASARCO proposed the Ray Land Exchange with the BLM in order to acquire public lands adjacent to its Ray Complex (Ray Mine and associated processing facilities near Hayden) and in the Casa Grande vicinity. In exchange, ASARCO is offering to the BLM private lands that will consolidate checkerboard land ownership and improve access to existing Federal land for traditional uses such as hunting and other recreation. By acquiring the Selected Lands, ASARCO is seeking to consolidate its land holdings within and near areas of ongoing mineral development and to use the Selected Lands to support and expand current and future mining-related operations. Through the exchange, the BLM would have an opportunity to improve resource management efficiency by disposing of heavily encumbered, isolated and difficult to manage public lands; and acquire lands that will consolidate ownership patterns in order to improve public access.

    The Proposed Action and alternatives presented and analyzed in the Ray Land Exchange/Plan Amendment Draft Supplemental EIS are generally the same as those presented and analyzed in the 1999 Final EIS. The environmental analysis is based on the foreseeable uses of the Selected Lands. The Draft Supplemental EIS includes an analysis of cumulative impacts to all resources and land uses, including an evaluation of potential impacts to Native American traditional values.

    The Proposed Action (Agency Preferred Alternative) is to complete the Ray Land Exchange between the BLM and ASARCO. The Selected Lands total approximately 10,976 acres and consist of 31 parcels of public lands located in Pinal and Gila Counties in south-central Arizona. Twenty-eight of the parcels occur in the Middle Gila River Basin between Mineral Creek to the north, the White Canyon Wilderness to the northwest, and the Dripping Spring Mountains to the east, and the Gila River to the south. These 28 parcels are clustered in three areas (the Ray Complex, Copper Butte/Buckeye, and Chilito/Hayden) near ASARCO's Ray Mine and the communities of Kearny, Hayden, and Winkelman, Arizona. The remaining three mineral estate only parcels are located about 50 miles west of the Ray Complex, near the community of Casa Grande in Pinal County. The Offered Lands total approximately 7,304 acres and consist of 18 parcels owned by ASARCO located in Pinal and Mohave Counties, also in Arizona. These parcels, which are presented throughout the Draft Supplemental EIS as five units (two single parcels and three parcel groups), include parcels along the Gila and Big Sandy Rivers, the Black Mountains, and the Cerbat Mountains. The Offered Lands are private inholdings within the jurisdictional boundaries of the Tucson and Kingman Field Offices of the BLM.

    The Draft Supplemental EIS also includes a No-Action Alternative under which no land exchange would occur nor would the Phoenix or Safford District RMPs need to be amended under this option. Two additional action alternatives are also analyzed in which less than the full amounts of land would be exchanged: The Buckeye Land Exchange Action Alternative and the Copper Butte Land Exchange Action Alternative. The Buckeye Land Exchange Alternative involves reducing the total acreage included in the land exchange under this alternative. The amount of the Selected Lands is reduced from approximately 10,976 acres to approximately 10,176 acres by excluding about 800 surface and subsurface acres in the Copper Butte area and removing 640 acres of the McCracken Mountains Parcels from the Offered Lands. The Copper Butte Land Exchange Alternative also involves a reduced acreage exchange from the full exchange Proposed Action. The Copper Butte Land Exchange Alternative involves reducing the total acreage of the Selected Lands from approximately 10,976 acres to approximately 9,161 acres by excluding surface and subsurface acres in the Copper Butte area and removing 1,703 acres of the McCracken Mountains Parcels from the Offered Lands.

    A plan amendment to the Phoenix and Safford RMPs is required as the selected lands have not been designated for disposal through previous BLM planning processes. The amendment to the Phoenix and Safford District RMPs would change the land tenure designation from “retention” to “disposal” for a total of approximately 10,339 acres. Specifically:

    1. Approximately 9,906 acres designated in the 1988 Phoenix RMP as part of the White Canyon Resource Conservation Area to be changed from retention to disposal; and

    2. Approximately 433 acres designated in the 1993 Safford District RMP as part of the former Safford District Long-Term Management Area to be changed from retention to disposal.

    The BLM was not required to conduct scoping for the Draft Supplemental EIS. However, the agency has conducted public outreach activities to inform the public and answer questions regarding the proposed land exchange. The efforts included updating the mailing list for the project, contacting mailing list persons via postcard and newsletter, providing a detailed project Web site, and interviewing key stakeholders to present the land exchange details and answer questions.

    Please note that public comments and information submitted including names, street addresses, and email addresses of persons who submit comments will be available for public review and disclosure at the above address during regular business hours, Monday through Friday, except holidays.

    Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.

    Authority:

    40 CFR 1506.6, 40 CFR 1506.10.

    A. Scott Feldhausen, Gila District Manager.
    [FR Doc. 2017-24823 Filed 11-16-17; 8:45 am] BILLING CODE 4310-32-P
    DEPARTMENT OF THE INTERIOR Bureau of Land Management [LLORV0000. L51010000. ER0000. LVRWH09H0480. 17XL5017AP. OROR065375. ID036029.HAG 17-0063] Notice of Availability of the Record of Decision for the Boardman to Hemingway Transmission Line Project and Approved Land-use Plan Amendments, Oregon AGENCY:

    Bureau of Land Management, Interior

    ACTION:

    Notice of availability.

    SUMMARY:

    The Bureau of Land Management (BLM) announces the availability of the Record of Decision (ROD) for the Boardman to Hemingway Transmission Line Project (B2H Project) and Approved Land-use Plan Amendments of the Baker and Southeastern Oregon Resource Management Plans (RMPs). The ROD constitutes the BLM's final decision regarding: (1) Approval to grant a Right-of-Way (ROW) to Idaho Power Company to construct, operate and maintain an extra-high-voltage, alternating-current transmission system; and (2) Amending portions of the BLM Baker and Southeastern Oregon RMPs.

    DATES:

    This decision takes effect immediately.

    ADDRESSES:

    The complete text of the ROD, along with the B2H Project Final Environmental Impact Statement (EIS) and supporting documents, is available on the BLM Web site at http://www.boardmantohemingway.com/ Copies of the ROD will be placed in all involved BLM offices and, for public review, at the locations identified in the SUPPLEMENTARY INFORMATION section of this notice.

    FOR FURTHER INFORMATION CONTACT:

    Tamara Gertsch, National Project Manager, Bureau of Land Management, Vale District Office, P.O. Box 655, Vale, OR 97918; telephone: (307) 775-6115; email: [email protected]. Persons who use a telecommunications device for the deaf may call the Federal Relay Service at (800) 877-8339 to contact the above individual during normal business hours. The service is available 24 hours a day, 7 days a week, to assist you in leaving a message or question for the above individual. You will receive a reply during normal business hours.

    For information related to the U.S. Forest Service's (USFS) involvement in the B2H Project, contact: Arlene Blumton, USFS Project Lead, telephone: (541) 962-8522, email: [email protected]. The USFS will provide a mailing address in its Notice of Availability (NOA) of the B2H Project Final EIS and Proposed Land-use Plan Amendments, and a notice of the draft USFS Record of Decision will be published in the Baker City Herald shortly after the BLM ROD.

    SUPPLEMENTARY INFORMATION:

    Idaho Power Company filed with the BLM an application for a ROW grant to use BLM-managed lands to construct, operate, and maintain the B2H Project, which is an approximately 294-mile-long overhead, single-circuit, 500-kilovolt (kV), alternating-current electric transmission line with additional ancillary facilities. The B2H Project will connect the northern terminus, the Longhorn Substation proposed by Bonneville Power Administration (BPA), which is approximately 4 miles northeast of the city of Boardman in Morrow County, Oregon, to the existing Hemingway Substation, which is near the city of Melba in Owyhee County, Idaho. When completed, the B2H Project will provide additional electrical load capacity between the Pacific Northwest Region and the Intermountain Region of Southwestern Idaho. The B2H Project also will alleviate existing transmission constraints and ensure that there is sufficient electrical capacity to meet present and forecasted customer needs as described in Idaho Power Company's 2015 Integrated Resource Plan (available online at https://www.idahopower.com/AboutUs/PlanningForFuture/irp/2015).

    The ROW width is 250 feet for its entire length, except for an approximately 7-mile section that will replace an existing 69-kV transmission line and will require a 90-foot-wide ROW within and parallel to the eastern boundary of the Naval Weapons Systems Training Facility, Boardman, as well as a 0.9-mile-long section that will require a 125-foot-wide ROW to relocate an existing 230-kV transmission line.

    Construction of the B2H Project will take 2 to 3 years and will consist of the following permanent facilities:

    • A single-circuit 500-kV electric transmission line (including structures and conductors, as well as other associated facilities) between the proposed Longhorn Substation and the existing Hemingway Substation;

    • Access roads and access-control gates;

    • A communication regeneration site every 40 miles;

    • Removal of approximately 7 miles of the existing Boardman to Tap 69-kV transmission line; and

    • Rerouting 0.9 mile of the existing Quartz to Tap 230-kV transmission line.

    The BLM will issue a separate, short-term ROW grant for temporary facilities, including temporary access roads (if any), and geotechnical investigation (also analyzed in the Final EIS) for a period of 5 years.

    The BLM prepared an EIS in accordance with the National Environmental Policy Act (NEPA) to analyze the direct, indirect, and cumulative environmental impacts associated with the proposed action and the alternatives. The BLM also identified and considered mitigation measures in the EIS to address the environmental impacts of the B2H Project and proposed plan amendments.

    The ROD approved the Agency Preferred Alternative identified in the Final EIS. The BLM issued the ROD based on compliance with relevant laws, regulations, policies, and plans, including those guiding agency decisions that may have an impact on resources and their values, services, and functions.

    The ROD approving the ROW grant requires, among other things, that the applicant satisfy specific mitigation measures. In particular, the sequence of mitigation actions will be the mitigation hierarchy (avoid, minimize, or compensate) as identified by the White House Council on Environmental Quality's (CEQ) NEPA implementing regulations (40 CFR 1508.20). Siting and design of the B2H Project required the application of design features of the B2H Project for environmental protection. Additionally, selective mitigation measures and implementation plans have been developed to consider the full mitigation hierarchy to avoid, minimize, or compensate for residual impacts on important, scarce, or sensitive resources. The priority is to mitigate impacts at sites of B2H Project activity in conformance with the land-use plan goals and objectives through impact avoidance or minimization of the impact, including those measures described in laws, regulations, policies, and land-use plans. If these types of mitigation measures are not sufficient to ameliorate anticipated direct, indirect, and cumulative impacts, and if substantial or significant residual impacts remain on important, scarce, or sensitive resources, the BLM is requiring compensatory mitigation to reduce these residual impacts or meet applicable land-use plan goals and objectives, consistent with the requirements of NEPA, as well as the BLM's statutory obligations under the Federal Land Policy and Management Act (FLPMA). Compensatory mitigation may be required for Greater sage-grouse, riparian conservation areas, cultural resources, and national historic trails. Based on the analysis in the Final EIS, the ROD also amends two BLM RMPs as follows:

    • Baker RMP—modifies 23 acres of visual resource management (VRM) Class II to Class IV in Burnt River Canyon;

    • Southeastern Oregon RMP—modifies 51 acres of VRM Class III to Class IV in the vicinity of the Oregon Trail—Birch Creek Area of Critical Environmental Concern (ACEC); and

    • Southeastern Oregon RMP—modifies 20 acres of VRM Class II to Class IV outside of and north of the Owyhee River below the Dam ACEC.

    The approved Land-use Plan Amendments specifically revise the RMPs to allow for the development of the B2H Project and ancillary facilities on land managed by the BLM. Consistent with NEPA, the BLM has integrated its land-use planning process with its evaluation of the B2H Project, including the scoping and public availability periods for the EIS. With approval of these Land-use Plan Amendments, the B2H Project will conform to the approved RMPs (43 CFR 1610.5-3).

    The evaluation of B2H Project compliance with Land and Resource Management Plans will be described by the USFS in its NOA for the B2H Project Final EIS and Approved Land-use Plan Amendments and its draft USFS ROD to be issued for comment following the BLM ROD.

    Copies of the Final EIS and ROD are available for public review during normal business hours at the following locations in Oregon:

    • Baker County Planning Department, 1995 Third St., Baker City • Baker County Library, 2400 Resort St., Baker City • BLM Baker Field Office, 3285 11th St., Baker City • Boardman City Library, 200 S. Main St., Boardman • Harney County Public Library, 80 W. D St., Burns • Grant County Planning Department, 201 S. Humboldt St., Canyon City • BLM Burns District Office, 28910 Hwy 20 W., Hines • Hermiston Public Library, 235 E. Gladys Avenue, Hermiston • Morrow County Planning Department, 205 NE. Third St., Irrigon • Grant County Library, 507 S. Canyon Blvd., John Day • La Grande Public Library, 2006 Fourth St., La Grande • Union County Planning Department, 1001 4th St., Suite C, La Grande • USFS Wallowa-Whitman National Forest Office, La Grande Ranger District, 3502 Highway 30, La Grande • USFS Wallowa-Whitman National Forest Headquarters, 1550 Dewey Ave., Baker City • Pendleton Public Library, 502 SW. Dorion Ave., Pendleton • Umatilla County Planning Department, 216 SE. Fourth St., Pendleton • BLM Prineville District Office, 3050 NE. 3rd St., Prineville • Ontario Library, 388 SW. Second Ave., Ontario • BLM Vale District Office, 100 Oregon St., Vale • Malheur County Planning Department, 251 B St. W., Vale • Oregon Department of Energy, 625 Marion St. NE., Salem • North Powder City Library, 290 E. St., North Powder

    Copies of the Final EIS and ROD are available for public review during normal business hours at the following locations in Idaho:

    • BLM Boise District Office, 3948 Development Ave., Boise • Boise Public Library, 715 S. Capitol Blvd., Boise • BLM Owyhee Field Office, 20 First Ave. W., Marsing • Owyhee County Planning Department, 17069 Basey St., Murphy • Nampa Public Library, 215 12th Avenue South Nampa, ID 83651 • Lizard Butte Library, 111 S 3rd Ave. W., Marsing

    On November 28, 2016, the NOA for the B2H Project Final EIS and Proposed Land-use Plan Amendments (81 FR 85632) was published in the Federal Register. The publication of the NOA initiated a 30-day protest period for the proposed land-use planning decision, as well as a simultaneous 60-day review by the Governor of Oregon to identify any inconsistencies with State or local plans, policies, or programs. At the close of the 30-day protest period, 53 protests were received. These protests were resolved by the BLM Director; individual protest response letters were sent to all protesting parties. Protest resolution is contained in the Director's Protest Summary Report, which is available online at http://www.blm.gov/pgdata/content/wo/en/prog/planning/planningoverview/protest_resolution.html. The proposed Land-use Plan Amendments were not modified as a result of the protest resolution, and the Oregon Governor's review did not identify any inconsistencies.

    Approval of this decision by the Acting Assistant Secretary—Land and Minerals Management is not subject to administrative appeal (43 CFR 4.410(a)(3)). Additionally, any challenge to this decision must be brought in Federal District Court and is subject to 42 U.S.C. 4370m-6.

    Authority:

    40 CFR 1506.6.

    Jamie E. Connell, State Director, Oregon/Washington.
    [FR Doc. 2017-25013 Filed 11-16-17; 8:45 am] BILLING CODE 4310-33-P
    INTERNATIONAL TRADE COMMISSION Notice of Receipt of Complaint; Solicitation of Comments Relating to the Public Interest AGENCY:

    U.S. International Trade Commission.

    ACTION:

    Notice.

    SUMMARY:

    Notice is hereby given that the U.S. International Trade Commission has received a complaint entitled Certain Microperforated Packaging Containing Fresh Produce, DN 3273; the Commission is soliciting comments on any public interest issues raised by the complaint or complainant's filing pursuant to the Commission's Rules of Practice and Procedure.

    FOR FURTHER INFORMATION CONTACT:

    Lisa R. Barton, Secretary to the Commission, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 205-2000. The public version of the complaint can be accessed on the Commission's Electronic Document Information System (EDIS) at https://edis.usitc.gov, and will be available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 205-2000.

    General information concerning the Commission may also be obtained by accessing its Internet server at United States International Trade Commission (USITC) at https://www.usitc.gov. The public record for this investigation may be viewed on the Commission's Electronic Document Information System (EDIS) at https://edis.usitc.gov. Hearing-impaired persons are advised that information on this matter can be obtained by contacting the Commission's TDD terminal on (202) 205-1810.

    SUPPLEMENTARY INFORMATION:

    The Commission has received a complaint and a submission pursuant to § 210.8(b) of the Commission's Rules of Practice and Procedure filed on behalf of Windham Packaging, LLC on November 13, 2017. The complaint alleges violations of section 337 of the Tariff Act of 1930 (19 U.S.C. 1337) in the importation into the United States, the sale for importation, and the sale within the United States after importation of certain microperforated packaging containing fresh produce. The complaint names as respondents Alpine Fresh, Inc. of Miami, FL; Apio, Inc. of Guadalupe, CA; B & G Foods North America, Inc. of Parsippany, NJ; Glory Foods, Inc. of Columbus, OH; Mann Packing Co., Inc. of Salinas, CA; and Taylor Farms California, Inc. of Salinas, CA. The complainant requests that the Commission issue a limited exclusion order, cease and desist orders and impose a bond upon respondents' alleged infringing articles during the 60-day Presidential review period pursuant to 19 U.S.C. 1337(j).

    Proposed respondents, other interested parties, and members of the public are invited to file comments, not to exceed five (5) pages in length, inclusive of attachments, on any public interest issues raised by the complaint or § 210.8(b) filing. Comments should address whether issuance of the relief specifically requested by the complainant in this investigation would affect the public health and welfare in the United States, competitive conditions in the United States economy, the production of like or directly competitive articles in the United States, or United States consumers.

    In particular, the Commission is interested in comments that:

    (i) Explain how the articles potentially subject to the requested remedial orders are used in the United States;

    (ii) Identify any public health, safety, or welfare concerns in the United States relating to the requested remedial orders;

    (iii) Identify like or directly competitive articles that complainant, its licensees, or third parties make in the United States which could replace the subject articles if they were to be excluded;

    (iv) Indicate whether complainant, complainant's licensees, and/or third party suppliers have the capacity to replace the volume of articles potentially subject to the requested exclusion order and/or a cease and desist order within a commercially reasonable time; and

    (v) Explain how the requested remedial orders would impact United States consumers.

    Written submissions must be filed no later than by close of business, eight calendar days after the date of publication of this notice in the Federal Register. There will be further opportunities for comment on the public interest after the issuance of any final initial determination in this investigation.

    Persons filing written submissions must file the original document electronically on or before the deadlines stated above and submit 8 true paper copies to the Office of the Secretary by noon the next day pursuant to § 210.4(f) of the Commission's Rules of Practice and Procedure (19 CFR 210.4(f)). Submissions should refer to the docket number (“Docket No. 3273”) in a prominent place on the cover page and/or the first page. (See Handbook for Electronic Filing Procedures, Electronic Filing Procedures.1 ) Persons with questions regarding filing should contact the Secretary (202-205-2000).

    1 Handbook for Electronic Filing Procedures: https://www.usitc.gov/documents/handbook_on_filing_procedures.pdf.

    Any person desiring to submit a document to the Commission in confidence must request confidential treatment. All such requests should be directed to the Secretary to the Commission and must include a full statement of the reasons why the Commission should grant such treatment. See 19 CFR 201.6. Documents for which confidential treatment by the Commission is properly sought will be treated accordingly. All such requests should be directed to the Secretary to the Commission and must include a full statement of the reasons why the Commission should grant such treatment. See 19 CFR 201.6. Documents for which confidential treatment by the Commission is properly sought will be treated accordingly. All information, including confidential business information and documents for which confidential treatment is properly sought, submitted to the Commission for purposes of this Investigation may be disclosed to and used: (i) By the Commission, its employees and Offices, and contract personnel (a) for developing or maintaining the records of this or a related proceeding, or (b) in internal investigations, audits, reviews, and evaluations relating to the programs, personnel, and operations of the Commission including under 5 U.S.C. Appendix 3; or (ii) by U.S. government employees and contract personnel,2 solely for cybersecurity purposes. All nonconfidential written submissions will be available for public inspection at the Office of the Secretary and on EDIS.3

    2 All contract personnel will sign appropriate nondisclosure agreements.

    3 Electronic Document Information System (EDIS): https://edis.usitc.gov.

    This action is taken under the authority of section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and of §§ 201.10 and 210.8(c) of the Commission's Rules of Practice and Procedure (19 CFR 201.10, 210.8(c)).

    By order of the Commission.

    Issued: November 13, 2017. Lisa R. Barton, Secretary to the Commission.
    [FR Doc. 2017-24921 Filed 11-16-17; 8:45 am] BILLING CODE 7020-02-P
    INTERNATIONAL TRADE COMMISSION [Investigation No. 731-TA-860 (Third Review)] Tin- and Chromium-Coated Steel Sheet From Japan AGENCY:

    United States International Trade Commission.

    ACTION:

    Notice of revised schedule for full five-year review.

    DATES:

    November 7, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Robert Casanova (202-708-2719), Office of Investigations, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436. Hearing-impaired persons can obtain information on this matter by contacting the Commission's TDD terminal on 202-205-1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at 202-205-2000. General information concerning the Commission may also be obtained by accessing its internet server (https://www.usitc.gov). The public record for this review may be viewed on the Commission's electronic docket (EDIS) at https://edis.usitc.gov.

    SUPPLEMENTARY INFORMATION:

    On October 20, 2017, the Commission established a schedule for the conduct of this full five-year review (82 FR 49661, October 26, 2017). The Commission is revising its schedule.

    The Commission's new schedule for the review is as follows: The prehearing conference (if needed) will be held on February 26, 2018; the hearing will be held at the U.S. International Trade Commission Building at 9:30 a.m. on February 27, 2018; and the deadline for filing posthearing briefs is March 7, 2018.

    For further information concerning this review see the Commission's notice cited above and the Commission's Rules of Practice and Procedure, part 201, subparts A through E (19 CFR part 201), and part 207, subparts A, D, E, and F (19 CFR part 207).

    Authority: This review is being conducted under authority of title VII of the Tariff Act of 1930; this notice is published pursuant to section 207.62 of the Commission's rules.

    By order of the Commission.

    Issued: November 14, 2017. William R. Bishop, Supervisory Hearings and Information Officer.
    [FR Doc. 2017-24980 Filed 11-16-17; 8:45 am] BILLING CODE 7020-02-P
    INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-1028] Certain Mobile Device Holders and Components Thereof; Commission's Determination To Review In-Part a Final Initial Determination Finding a Violation of Section 337; Request for Written Submissions AGENCY:

    U.S. International Trade Commission.

    ACTION:

    Notice.

    SUMMARY:

    Notice is hereby given that the U.S. International Trade Commission has determined to review in-part the final initial determination (“ID”) issued by the presiding administrative law judge (“ALJ”) on September 12, 2017, finding a violation of section 337 in the above-captioned investigation. Specifically, the Commission has determined to review the ID's analysis and findings with respect to the economic prong of the domestic industry. The Commission also requests written submissions, under the schedule set forth below, on remedy, the public interest, and bonding.

    FOR FURTHER INFORMATION CONTACT:

    Amanda Pitcher Fisherow, Esq., Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 205-2737. Copies of non-confidential documents filed in connection with this investigation are or will be available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 205-2000. General information concerning the Commission may also be obtained by accessing its Internet server at https://www.usitc.gov. The public record for this investigation may be viewed on the Commission's electronic docket (EDIS) at https://edis.usitc.gov. Hearing-impaired persons are advised that information on this matter can be obtained by contacting the Commission's TDD terminal on (202) 205-1810.

    SUPPLEMENTARY INFORMATION:

    The Commission instituted this investigation on November 14, 2016, based on a complaint and supplements, filed on behalf of Nite Ize, Inc. of Boulder, Colorado (“Nite Ize”). 81 FR 79519-20 (Nov. 14, 2016). The complaint, as supplemented, alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain mobile device holders and components thereof by reason of infringement of certain claims of U.S. Patent No. 8,602,376 (“the '376 patent”), U.S. Patent No. 8,870,146 (“the '146 patent”), U.S. Patent No. D734,746 (“the '746 patent”), and U.S. Patent No. D719,959 (“the '959 patent”). The complaint further alleges that an industry in the United States exists as required by subsection (a)(2) of section 337. The Commission's notice of investigation named the following respondents: REXS LLC of Lewes, Delaware; Spinido, Inc. of Brighton, Colorado; Guangzhou Kuaguoyi E-commerce Co., Ltd. d/b/a Kagu Culture (“Kagu Culture”) of Baiyum, China; Sunpauto Co., Ltd. of Kowloon, Hong Kong; Shenzhen Topworld Technology Co. d/b/a IdeaPro (“IdeaPro”) of Hong Kong, Hong Kong; Ninghuaxian Wangfulong Chaojishichang Youxian Gongsi, Ltd., d/b/a EasybuyUS of Shanghai, China; Chang Lee d/b/a Frentaly of Duluth, Georgia; Trendbox USA LLC d/b/a Trendbox (“Trendbox”) of Scottsdale, Arizona; Tenswall d/b/a Shenzhen Tenswall International Trading Co. of La Puente, California; Luo Jieqiong d/b/a Wekin of Chang Sha, China; Pecham d/b/a Baichen Technology Ltd. of Wan Chai, Hong Kong; Cyrift d/b/a Guangzhou Sunway Ecommerce LLC. of Guangzhou, China; Rymemo d/b/a Global Box, LLC of Dunbar, Pennsylvania; Yuan I d/b/a Bestrix of Hubei, China; Zhongshan Feiyu Hardware Technology Co., Ltd d/b/a YouFo (“YouFo”) of ZhongShan City, China; and Shenzhen Youtai Trade Company Limited, d/b/a NoChoice; Luo, Qiben, d/b/a Lita International Shop of Nanshan; Shenzhen New Dream Technology Co., Ltd., d/b/a Newdreams (“Newdreams”); Shenznen Gold South Technology Co., Ltd. d/b/a Baidatong; Wang Zhi Gang d/b/a IceFox (“Icefox”); Dang Yuya d/b/a Sminiker; Lin Zhen Mei d/b/a Anson (“Anson”); Wu Xuying d/b/a Novoland; Shenzhen New Dream Sailing Electronic Technology Co., Ltd. d/b/a MegaDream; Tontek d/b/a Shenzhen Hetongtai Electronics Co., Ltd.; Scotabc d/b/a ShenChuang Optoelectronics Technology Co., Ltd.; Zhiping Zhou d/b/a Runshion; Huijukon d/b/a Shenzhen Hui Ju Kang Technology Co. Ltd.; Barsone d/b/a Shenzhen Senweite Electronic Commerce Ltd.; Oumeiou d/b/a Shenzhen Oumeiou Technology Co., Ltd. (“Oumeiou”); Grando d/b/a Shenzhen Dashentai Network Technology Co., Ltd.; Shenzhen Yingxue Technology Co., Ltd. (“Shenzhen Yingxue”); Shenzhen Longwang Technology Co., Ltd., d/b/a LWANG; Hu Peng d/b/a AtomBud; Wang Guoxiang d/b/a Minse (“Minse”) all of Shenzhen, China. The Office of Unfair Import Investigations (“OUII”) was named as a party to the investigation.

    Global Box, LLC and Chang Lee d/b/a Frentaly were terminated on the basis of a consent order. Commission Notice (March 21, 2017); Commission Notice (May 15, 2017). Barsone d/b/a Shenzhen Senweite Electronic Commerce Ltd., Shenzhen Youtai Trade Company Limited, d/b/a NoChoice, Ninghuaxian Wangfulong Chaojishichang Youxian Gongsi, Ltd., d/b/a EasybuyUS, Shenzhen Gold South Technology Co., Ltd. d/b/a Baidatong, Cyrift d/b/a Guangzhou Sunway E-Commerce LLC, Hu Peng d/b/a AtomBud, Grando d/b/a Shenzhen Dashentai Network Technology Co., Ltd., Huijukon d/b/a Shenzhen Hui Ju Kang Technology Co. Ltd., Luo, Qiben, d/b/a Lita International Shop, Shenzhen New Dream Sailing Electronic Technology Co., Ltd. d/b/a MegaDream, Spinido Inc., Dang Yuya d/b/a Sminiker, and Yuan I d/b/a Bestrix were terminated because service could not be effected. Commission Notice (June 13, 2017). The remaining respondents were previously found in default (collectively, “the Defaulting Respondents”). Commission Notice (May 26, 2017). In addition, the '746 and '959 patents were previously terminated from the investigation. Commission Notice (July 28, 2017).

    On May 18, 2017, Nite Ize filed a Motion for Summary Determination of Violation by the Defaulting Respondents and for a Recommended Determination on Remedy and Bonding, Including Issuance of a General Exclusion Order, Limited Exclusion Orders, and Cease and Desist Orders. On June 16, 2017, the ALJ issued Order No. 14 granting in-part Nite Ize's motion for summary determination. The Commission determined not to review that ID. Commission Notice (July 14, 2017).

    On September 12, 2017, the ALJ issued his final ID finding a violation of section 337 of the Tariff Act of 1930, 19 U.S.C. 1337. On the same day, the ALJ issued his Recommended Determination on Remedy and Bonding. No petitions for review were filed.

    The Commission has determined to review the subject ID in-part. Specifically, the Commission has determined to review the ID's analysis and findings with respect to the economic prong of the domestic industry requirement. The Commission does not request any submissions on the issue under review.

    In connection with the final disposition of this investigation, the Commission may (1) issue an order that could result in the exclusion of the subject articles from entry into the United States, and/or (2) issue one or more cease and desist orders that could result in the respondent(s) being required to cease and desist from engaging in unfair acts in the importation and sale of such articles. Accordingly, the Commission is interested in receiving written submissions that address the form of remedy, if any, that should be ordered. If a party seeks exclusion of an article from entry into the United States for purposes other than entry for consumption, the party should so indicate and provide information establishing that activities involving other types of entry either are adversely affecting it or likely to do so. For background, see Certain Devices for Connecting Computers via Telephone Lines, Inv. No. 337-TA-360, USITC Pub. No. 2843 (Dec. 1994) (Comm'n Op.). In particular, the written submissions should address any request for a cease and desist order in the context of recent Commission opinions, including those in Certain Arrowheads with Deploying Blades and Components Thereof and Packaging Therefor, Inv. No. 337-TA-977, Comm'n Op. (Apr. 28, 2017) and Certain Electric Skin Care Devices, Brushes and Chargers Therefor, and Kits Containing the Same, Inv. No. 337-TA-959, Comm'n Op. (Feb. 13, 2017). Specifically, if Complainant seeks a cease and desist order against a defaulting respondent, the written submissions should respond to the following requests:

    (1) Please identify with citations to the record any information regarding commercially significant inventory in the United States as to each respondent against whom a cease and desist order is sought. If Complainant also relies on other significant domestic operations that could undercut the remedy provided by an exclusion order, please identify with citations to the record such information as to each respondent against whom a cease and desist order is sought.

    (2) In relation to the infringing products, please identify any information in the record, including allegations in the pleadings, that addresses the existence of any domestic inventory, any domestic operations, or any sales-related activity directed at the United States for each respondent against whom a cease and desist order is sought.

    If the Commission contemplates some form of remedy, it must consider the effects of that remedy upon the public interest. The factors the Commission will consider include the effect that an exclusion order and/or cease and desist orders would have on (1) the public health and welfare, (2) competitive conditions in the U.S. economy, (3) U.S. production of articles that are like or directly competitive with those that are subject to investigation, and (4) U.S. consumers. The Commission is therefore interested in receiving written submissions that address the aforementioned public interest factors in the context of this investigation.

    If the Commission orders some form of remedy, the U.S. Trade Representative, as delegated by the President, has 60 days to approve or disapprove the Commission's action. See Presidential Memorandum of July 21, 2005, 70 FR 43251 (July 26, 2005). During this period, the subject articles would be entitled to enter the United States under bond, in an amount determined by the Commission and prescribed by the Secretary of the Treasury. The Commission is therefore interested in receiving submissions concerning the amount of the bond that should be imposed if a remedy is ordered.

    Written Submissions: Each party's written submission must be filed no later than close of business on Thursday, November 30, 2017. Reply submissions must be filed no later than the close of business on Thursday, December 7, 2017. No further submissions on these issues will be permitted unless otherwise ordered by the Commission.

    Persons filing written submissions must file the original document electronically on or before the deadlines stated above and submit 8 true paper copies to the Office of the Secretary by noon the next day pursuant to Commission Rule 210.4(f), 19 CFR 210.4(f). Submissions should refer to the investigation number (“Inv. No. 337-TA-1028”) in a prominent place on the cover page and/or the first page. (See Handbook for Electronic Filing Procedures, https://www.usitc.gov/secretary/documents/handbook_on_filing_procedures.pdf). Persons with questions regarding filing should contact the Secretary, (202) 205-2000.

    Any person desiring to submit a document to the Commission in confidence must request confidential treatment. All such requests should be directed to the Secretary to the Commission and must include a full statement of the reasons why the Commission should grant such treatment. See 19 CFR 201.6. Documents for which confidential treatment by the Commission is properly sought will be treated accordingly. All information, including confidential business information and documents for which confidential treatment is properly sought, submitted to the Commission for purposes of this Investigation may be disclosed to and used: (i) By the Commission, its employees and Offices, and contract personnel (a) for developing or maintaining the records of this or a related proceeding, or (b) in internal investigations, audits, reviews, and evaluations relating to the programs, personnel, and operations of the Commission including under 5 U.S.C. Appendix 3; or (ii) by U.S. government employees and contract personnel,1 solely for cybersecurity purposes. All non-confidential written submissions will be available for public inspection at the Office of the Secretary and on EDIS.

    1 All contract personnel will sign appropriate nondisclosure agreements.

    The authority for the Commission's determination is contained in section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, and in Part 210 of the Commission's Rules of Practice and Procedure, 19 CFR part 210.

    By order of the Commission.

    Issued: November 13, 2017. Lisa R. Barton, Secretary to the Commission.
    [FR Doc. 2017-24927 Filed 11-16-17; 8:45 am] BILLING CODE 7020-02-P
    DEPARTMENT OF LABOR Employment and Training Administration Agency Information Collection Activities; Comment Request; Workforce Flexibility (Workflex) Plan Submission and Reporting Requirements ACTION:

    Notice.

    SUMMARY:

    The Department of Labor (DOL), Employment and Training Administration is soliciting comments concerning a proposed extension for the authority to conduct the information collection request (ICR) titled, “Workforce Flexibility (Workflex) Plan Submission and Reporting Requirements.” This comment request is part of continuing Departmental efforts to reduce paperwork and respondent burden in accordance with the Paperwork Reduction Act of 1995 (PRA).

    DATES:

    Consideration will be given to all written comments received by January 16, 2018.

    ADDRESSES:

    A copy of this ICR with applicable supporting documentation, including a description of the likely respondents, proposed frequency of response, and estimated total burden, may be obtained free at https://doleta.gov/wioa/State_Plan_Resources.cfm or by contacting Heather Fleck by telephone at 202-693-2956, TTY 877-889-5627 (these are not toll-free numbers), or by email at [email protected]

    Submit written comments about, or requests for a copy of, this ICR by mail or courier to the U.S. Department of Labor, Employment and Training Administration, Division of WIOA Adult Services and Workforce Systems, U.S. Department of Labor, 200 Constitution Avenue NW., Room S4209, Washington, DC 20210; by email: [email protected]; or by Fax 202-693-3015.

    FOR FURTHER INFORMATION CONTACT:

    Heather Fleck by telephone at 202-693-2956 (this is not a toll-free number) or by email at [email protected]

    SUPPLEMENTARY INFORMATION:

    The DOL, as part of continuing efforts to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies an opportunity to comment on proposed and/or continuing collections of information before submitting them to the OMB for final approval. This program helps to ensure requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements can be properly assessed.

    Section 190 of the Workforce Innovation and Opportunity Act (WIOA) (Pub. L. 113-128, July 22, 2014) permits states to apply for Workflex waiver authority. The Act and 20 CFR 679.630 provide that the Secretary may grant Workflex waiver authority for up to five years pursuant to a Workflex plan submitted by a state. Under Workflex, governors are granted the authority to approve requests submitted by their local areas to waiver certain statutory and regulatory provisions of WIOA Title I programs. States may also request waivers from the Secretary of certain requirements of the Wagner-Peyser Act (Sections 8-10) as well as certain provisions of the Older Americans Act of 1965 (OAA) (42 U.S.C. 3056d(b)) for state agencies on aging with respect to activities carried out using funds allotted under OAA section 506(b). One of the underlying principles for granting Workflex waivers is that the waivers will result in improved performance outcomes for persons served and that waiver authority will be granted in consideration of improved performance.

    This is a continuation of the previous collection instructions request under WIA, and WIOA continues to authorize this information collection.

    This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless it is approved by the OMB under the PRA and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid Control Number. See 5 CFR 1320.5(a) and 1320.6.

    Interested parties are encouraged to provide comments to the contact shown in the ADDRESSES section. Comments must be written to receive consideration, and they will be summarized and included in the request for OMB approval of the final ICR. In order to help ensure appropriate consideration, comments should mention OMB Number: 1205-0432.

    Submitted comments will also be a matter of public record for this ICR and posted on the Internet, without redaction. The DOL encourages commenters not to include personally identifiable information, confidential business data, or other sensitive statements/information in any comments.

    The DOL is particularly interested in comments that:

    • Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

    • Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

    • Enhance the quality, utility, and clarity of the information to be collected; and

    • Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

    Agency: DOL-ETA.

    Type of Review: Revision.

    Title of Collection: Workflex Plan Submission and Reporting Requirements.

    Form: Workforce Flexibility (Workflex) Plan Collection Form.

    OMB Control Number: 1205-0432.

    Affected Public: State and local governments.

    Estimated Number of Respondents: 5.

    Frequency: 5 state plans annually; 204 quarterly reports.

    Total Estimated Annual Responses: 5 state plans annually; 204 quarterly reports.

    Estimated Average Time per Response: 18 hours.

    Estimated Total Annual Burden Hours: 210 hours.

    Total Estimated Annual Other Cost Burden: $0.

    Authority:

    44 U.S.C. 3506(c)(2)(A).

    Nancy M. Rooney, Deputy Assistant Secretary for Employment and Training, Labor.
    [FR Doc. 2017-24998 Filed 11-16-17; 8:45 am] BILLING CODE 4510-FN-P
    DEPARTMENT OF LABOR Office of the Secretary Meeting of the Labor Advisory Committee for Trade Negotiation and Trade Policy AGENCY:

    Bureau of International Labor Affairs, U.S. Department of Labor and Office of the United States Trade Representative, Labor Advisory Committee for Trade Negotiations and Trade Policy.

    ACTION:

    Meeting notice.

    SUMMARY:

    Notice is hereby given of a meeting of the Labor Advisory Committee for Trade Negotiation and Trade Policy.

    DATES:

    December 15, 2017 2:00 p.m. to 4:00 p.m.

    ADDRESSES:

    U.S. Department of Labor, Secretary's Conference Room, 200 Constitution Ave. NW., Washington, DC.

    FOR FURTHER INFORMATION CONTACT:

    Anne M. Zollner, Chief, Trade Policy and Negotiations Division; Phone: (202) 693-4890.

    SUPPLEMENTARY INFORMATION:

    The meeting will include a review and discussion of current issues which influence U.S. trade policy. Potential U.S. negotiating objectives and bargaining positions in current and anticipated trade negotiations will be discussed. Pursuant to 19 U.S.C. 2155(f)(2)(A), it has been determined that the meeting will be concerned with matters the disclosure of which would seriously compromise the Government's negotiating objectives or bargaining positions. Therefore, the meeting is exempt from the requirements of subsections (a) and (b) of sections 10 and 11 of the Federal Advisory Committee Act (relating to open meetings, public notice, public participation, and public availability of documents). 5 U.S.C. app. Accordingly, the meeting will be closed to the public.

    Signed at Washington, DC, the 14th day of November 2017. Martha E. Newton, Deputy Undersecretary, Bureau of International Labor Affairs.
    [FR Doc. 2017-25011 Filed 11-16-17; 8:45 am] BILLING CODE 4510-28-P
    DEPARTMENT OF LABOR Office of the Secretary Agency Information Collection Activities; Submission for OMB Review; Comment Request; Hazard Communication Standard ACTION:

    Notice.

    SUMMARY:

    The Department of Labor (DOL) is submitting the Mine Safety and Health Administration (MSHA) sponsored information collection request (ICR) titled, “Hazard Communication Standard,” to the Office of Management and Budget (OMB) for review and approval for continued use, without change, in accordance with the Paperwork Reduction Act of 1995 (PRA). Public comments on the ICR are invited.

    DATES:

    The OMB will consider all written comments that agency receives on or before December 18, 2017.

    ADDRESSES:

    A copy of this ICR with applicable supporting documentation; including a description of the likely respondents, proposed frequency of response, and estimated total burden may be obtained free of charge from the RegInfo.gov Web site at http://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=201706-1219-001 (this link will only become active on the day following publication of this notice) or by contacting Michel Smyth by telephone at 202-693-4129, TTY 202-693-8064, (these are not toll-free numbers) or by email at [email protected]

    Submit comments about this request by mail to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for DOL-MSHA, Office of Management and Budget, Room 10235, 725 17th Street NW., Washington, DC 20503; by Fax: 202-395-5806 (this is not a toll-free number); or by email: [email protected] Commenters are encouraged, but not required, to send a courtesy copy of any comments by mail or courier to the U.S. Department of Labor-OASAM, Office of the Chief Information Officer, Attn: Departmental Information Compliance Management Program, Room N1301, 200 Constitution Avenue NW., Washington, DC 20210; or by email: [email protected]

    FOR FURTHER INFORMATION CONTACT:

    Michel Smyth by telephone at 202-693-4129, TTY 202-693-8064, (these are not toll-free numbers) or by email at [email protected]

    SUPPLEMENTARY INFORMATION:

    This ICR seeks to extend PRA authority for the Hazard Communication Standard information collection requirements codified in regulations 30 CFR part 47. The Standard requires a mine operator to use labels or other forms of warning necessary to inform miners of all hazards to which the miners are exposed, relevant symptoms and emergency treatment, and proper conditions of safety use or exposure. Federal Mine Safety and Health Act of 1977 sections 101(a)(7) and 103(h) authorize this information collection. See 30 U.S.C. 811(a)(7), 813(h).

    This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless it is approved by the OMB under the PRA and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid Control Number. See 5 CFR 1320.5(a) and 1320.6. The DOL obtains OMB approval for this information collection under Control Number 1219-0133.

    OMB authorization for an ICR cannot be for more than three (3) years without renewal, and the current approval for this collection is scheduled to expire on December 31, 2017. The DOL seeks to extend PRA authorization for this information collection for three (3) more years, without any change to existing requirements. The DOL notes that existing information collection requirements submitted to the OMB receive a month-to-month extension while they undergo review. For additional substantive information about this ICR, see the related notice published in the Federal Register on June 12, 2017 (82 FR 26955).

    Interested parties are encouraged to send comments to the OMB, Office of Information and Regulatory Affairs at the address shown in the ADDRESSES section within thirty (30) days of publication of this notice in the Federal Register. In order to help ensure appropriate consideration, comments should mention OMB Control Number 1219-0133. The OMB is particularly interested in comments that:

    • Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

    • Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

    • Enhance the quality, utility, and clarity of the information to be collected; and

    • Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

    Agency: DOL-MSHA.

    Title of Collection: Hazard Communication Standard.

    OMB Control Number: 1219-0133.

    Affected Public: Private Sector—businesses or other for-profits.

    Total Estimated Number of Respondents: 21,910.

    Total Estimated Number of Responses: 1,253,295.

    Total Estimated Annual Time Burden: 182,835 hours.

    Total Estimated Annual Other Costs Burden: $11,108.

    Authority:

    44 U.S.C. 3507(a)(1)(D).

    Dated: November 13, 2017. Michel Smyth, Departmental Clearance Officer.
    [FR Doc. 2017-24994 Filed 11-16-17; 8:45 am] BILLING CODE 4510-43-P
    DEPARTMENT OF LABOR Bureau of Labor Statistics Information Collection Activities; Comment Request AGENCY:

    Bureau of Labor Statistics, Department of Labor.

    ACTION:

    Notice of information collection; request for comment.

    SUMMARY:

    The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information, in accordance with the Paperwork Reduction Act of 1995. This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. The Bureau of Labor Statistics (BLS) is soliciting comments on the proposed revision of the “BLS Occupational Safety and Health Statistics (OSHS) Cooperative Agreement application package.” A copy of the proposed information collection request can be obtained by contacting the individual listed below in the Addresses section of this notice.

    DATES:

    Written comments must be submitted to the office listed in the Addresses section of this notice on or before January 16, 2018.

    ADDRESSES:

    Send comments to Nora Kincaid, BLS Clearance Officer, Division of Management Systems, Bureau of Labor Statistics, Room 4080, 2 Massachusetts Avenue NE., Washington, DC 20212. Written comments also may be transmitted by fax to 202-691-5111 (this is not a toll free number).

    FOR FURTHER INFORMATION CONTACT:

    Nora Kincaid, BLS Clearance Officer, telephone number 202-691-7628 (this is not a toll free number.) (See ADDRESSES section.)

    SUPPLEMENTARY INFORMATION: I. Background

    The Secretary of Labor has delegated to the BLS the authority to collect, compile, and analyze statistical data on work-related injuries and illnesses, as authorized by the Occupational Safety and Health Act of 1970 (Pub. L. 91-596). The Cooperative Agreement is designed to allow the BLS to ensure conformance with program objectives. The BLS has full authority over the financial operations of the statistical program. The existing collection of information allows Federal staff to negotiate the Cooperative Agreement with the State Grant Agencies and monitor their financial and programmatic performance and adherence to administrative requirements imposed by the Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards (2 CFR 200) and other grant related regulations. The information collected also is used for planning and budgeting at the Federal level and in meeting Federal reporting requirements. The BLS requires financial reporting that will produce the information that is needed to monitor the financial activities of the BLS Occupational Safety and Health Statistics grantees.

    The Cooperative Agreement application package being submitted for approval is representative of the package sent every year to state agencies. The work statements included in the Cooperative Agreement application also are representative of what is included in the whole OSHS Cooperative Agreement package. The final Cooperative Agreement, including the work statements, will be submitted separately to the Office of Management and Budget for review of any minor year-to-year information collection burden changes they may contain.

    II. Current Action

    Office of Management and Budget clearance is being sought for the OSHS Cooperative Agreement application package. Two new forms, the OSHS Budget Variance form and the OSHS Federal Reconciliation Worksheet (FRW-B): Additional Activity to Maintain Currency (AAMC) form, are being included in this application package. The OSHS Budget Variance form will be used to request budget variances, or small movements of funds between the OSHS programs prior to closeout. The OSHS FRW-B: AAMC form will be used to reconcile OSHS AAMC expenditures and obligations as part of the closeout process.

    III. Desired Focus of Comments

    The BLS is particularly interested in comments that:

    • Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility.

    • Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used.

    • Enhance the quality, utility, and clarity of the information to be collected.

    • Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses.

    Title of Collection: BLS Occupational Safety and Health Statistics Cooperative Agreement Application Package.

    OMB Number: 1220-0149.

    Type of Review: Revision of a currently approved collection.

    Affected Public: State Governments.

    Information collection Respondents Frequency Responses Time Total hours BLS-OSHS Work Statements 56 1 56 2 hours 112 BLS-OSHS2 56 4 224 1 hour 224 BLS-OSHS TCF 56 1 56 5-10 minutes 4.7-9.3 OSHS Budget Variance Request Form 0-40 1 0-40 5-25 minutes 0-16.7 BLS-OSHS FRW-A: Base Programs 56 1 56 20-30 minutes 18.7-28 BLS-OSHS FRW-B: AAMC 0-10 1 0-10 20-30 minutes 0-5 BLS-OSHS Property Listing 0-56 1 0-56 20-30 minutes 0-28 Total 56 392-498 359.4-423 Average Totals 56 445 391

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

    Signed at Washington, DC, this 9th day of November 2017. Kimberley D. Hill, Chief, Division of Management Systems.
    [FR Doc. 2017-24996 Filed 11-16-17; 8:45 am] BILLING CODE 4510-24-P
    DEPARTMENT OF LABOR Bureau of Labor Statistics Information Collection Activities; Comment Request AGENCY:

    Bureau of Labor Statistics, Department of Labor.

    ACTION:

    Notice of information collection; request for comment.

    SUMMARY:

    The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information, in accordance with the Paperwork Reduction Act of 1995. This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. The Bureau of Labor Statistics (BLS) is soliciting comments on the proposed extension without change of a currently approved collection of the “Labor Market Information (LMI) Cooperative Agreement application package.” A copy of the proposed information collection request can be obtained by contacting the individual listed below in the Addresses section of this notice.

    DATES:

    Written comments must be submitted to the office listed in the Addresses section of this notice on or before JANUARY 16, 2018.

    ADDRESSES:

    Send comments to Nora Kincaid, BLS Clearance Officer, Division of Management Systems, Bureau of Labor Statistics, Room 4080, 2 Massachusetts Avenue NE., Washington, DC 20212. Written comments also may be transmitted by fax to 202-691-5111 (this is not a toll free number).

    FOR FURTHER INFORMATION CONTACT:

    Nora Kincaid, BLS Clearance Officer, at 202-691-7628 (this is not a toll free number). (See Addresses section.)

    SUPPLEMENTARY INFORMATION:

    I. Background

    The BLS enters into Cooperative Agreements with State Workforce Agencies (SWAs) annually to provide financial assistance to the SWAs for the production and operation of the following LMI statistical programs: Current Employment Statistics, Local Area Unemployment Statistics, Occupational Employment Statistics, and Quarterly Census of Employment and Wages. The Cooperative Agreement provides the basis for managing the administrative and financial aspects of these programs.

    The existing collection of information allows Federal staff to negotiate the Cooperative Agreement with the SWAs and monitor their financial and programmatic performance and adherence to administrative requirements imposed by the Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards (2 CFR 200) and other grant related regulations. The information collected also is used for planning and budgeting at the Federal level and in meeting Federal reporting requirements.

    The Cooperative Agreement application package being submitted for approval is representative of the package sent every year to state agencies. The work statements included in the Cooperative Agreement application also are representative of what is included in the whole LMI Cooperative Agreement package. The final Cooperative Agreement, including the work statements, will be submitted separately to the Office of Management and Budget for review of any minor year-to-year information collection burden changes they may contain.

    II. Current Action

    Office of Management and Budget clearance is being sought for the LMI Cooperative Agreement application package.

    III. Desired Focus of Comments

    The BLS is particularly interested in comments that:

    • Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility.

    • Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used.

    • Enhance the quality, utility, and clarity of the information to be collected.

    • Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses.

    Title of Collection: Labor Market Information (LMI) Cooperative Agreement Application Package.

    OMB Number: 1220-0079.

    Type of Review: Extension without change of a currently approved collection.

    Affected Public: State, Local, or Tribal Governments.

    Frequency: Monthly, quarterly, annually.

    Information collection Respondents Frequency Responses Time Total hours Work Statements 54 1 54 1-2 hr 54-108 BIF (LMI 1A) 54 1 54 1-6 hr 54-324 BIF (LMI 1B) 0-30 1 0-30 1-6 hr 0-180 Quarterly Automated Financial Reports 48 4 192 10-50 min 32-160 Monthly Automated Financial Reports 48 8* 384 5-25 min 32-160 BLS Cooperative Statistics Financial Report (LMI 2A) 7 12 84 1-5 hr 84-420 Quarterly Status Report (LMI 2B) 0-30 4 0-120 1 hr 0-120 Budget Variance Request Form 0-54 1 0-54 5-25 min 0-23 Transmittal and Certification Form 54 1 54 5-10 min 4.5-9 FRW-A: Base Programs 54 1 54 20-30 min 18-27 FRW-B: AAMC 0-30 1 0-30 20-30 min 0-15 Property Listing 0-54 1 0-54 20-30 min 0-27 Total 54 876-1,164 278.5-1573 Average Totals 54 1,020 925.75 * Reports are not received for end-of-quarter months, i.e., December, March, June, and September.

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

    Signed at Washington, DC, this 9th day of November 2017. Kimberley D. Hill, Chief, Division of Management Systems.
    [FR Doc. 2017-24997 Filed 11-16-17; 8:45 am] BILLING CODE 4510-24-P
    DEPARTMENT OF LABOR Mine Safety and Health Administration [OMB Control No. 1219-0066] Proposed Extension of Information Collection; Permissible Equipment Testing AGENCY:

    Mine Safety and Health Administration, Labor.

    ACTION:

    Request for public comments.

    SUMMARY:

    The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed collections of information in accordance with the Paperwork Reduction Act of 1995. This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. Currently, the Mine Safety and Health Administration (MSHA) is soliciting comments on the information collection for Permissible Equipment Testing.

    DATES:

    All comments must be received on or before January 16, 2018.

    ADDRESSES:

    Comments concerning the information collection requirements of this notice may be sent by any of the methods listed below.

    Federal E-Rulemaking Portal: http://www.regulations.gov. Follow the on-line instructions for submitting comments for docket number MSHA-2017-0034.

    Regular Mail: Send comments to USDOL-MSHA, Office of Standards, Regulations, and Variances, 201 12th Street South, Suite 4E401, Arlington, VA 22202-5452.

    Hand Delivery: USDOL—Mine Safety and Health Administration, 201 12th Street South, Suite 4E401, Arlington, VA 22202-5452. Sign in at the receptionist's desk on the 4th floor via the East elevator.

    FOR FURTHER INFORMATION CONTACT:

    Sheila McConnell, Director, Office of Standards, Regulations, and Variances, MSHA, at [email protected] (email); (202) 693-9440 (voice); or (202) 693-9441 (facsimile).

    SUPPLEMENTARY INFORMATION:

    I. Background

    Section 103(h) of the Federal Mine Safety and Health Act of 1977 (Mine Act), 30 U.S.C. 813(h), authorizes MSHA to collect information necessary to carry out its duty in protecting the safety and health of miners. Further, section 101(a) of the Mine Act, 30 U.S.C. 811, authorizes the Secretary of Labor to develop, promulgate, and revise as may be appropriate, improved mandatory health or safety standards for the protection of life and prevention of injuries in coal or other mines.

    MSHA is responsible for the inspection, testing approval and certification, and quality control of mining equipment and components, materials, instruments, and explosives used in both underground and surface coal, metal, and nonmetal mines. Title 30 Code of Federal Regulations parts 6 through 36 contain procedures by which manufacturers may apply for and have equipment approved as “permissible” for use in mines.

    II. Desired Focus of Comments

    MSHA is soliciting comments concerning the proposed information collection related to Permissible Equipment Testing. MSHA is particularly interested in comments that:

    • Evaluate whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information has practical utility;

    • Evaluate the accuracy of MSHA's estimate of the burden of the collection of information, including the validity of the methodology and assumptions used;

    • Suggest methods to enhance the quality, utility, and clarity of the information to be collected; and

    • Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

    The information collection request will be available on http://www.regulations.gov. MSHA cautions the commenter against providing any information in the submission that should not be publicly disclosed. Full comments, including personal information provided, will be made available on www.regulations.gov and www.reginfo.gov.

    The public may also examine publicly available documents at USDOL—Mine Safety and Health Administration, 201 12th South, Suite 4E401, Arlington, VA 22202-5452. Sign in at the receptionist's desk on the 4th floor via the East elevator.

    Questions about the information collection requirements may be directed to the person listed in the FOR FURTHER INFORMATION CONTACT section of this notice.

    III. Current Actions

    This request for collection of information contains provisions for Permissible Equipment Testing. MSHA has updated the data with respect to the number of respondents, responses, burden hours, and burden costs supporting this information collection request.

    Type of Review: Extension, without change, of a currently approved collection.

    Agency: Mine Safety and Health Administration.

    OMB Number: 1219-0066.

    Affected Public: Business or other for-profit.

    Number of Respondents: 139.

    Frequency: On occasion.

    Number of Responses: 296.

    Annual Burden Hours: 3,198 hours.

    Annual Respondent or Recordkeeper Cost: $1,732,175.

    MSHA Forms: MSHA Form 2000-38, Electrically Operated Mining Equipment U.S. Department of Labor Field Approval Application (Coal Operator).

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

    Sheila McConnell, Certifying Officer.
    [FR Doc. 2017-24995 Filed 11-16-17; 8:45 am] BILLING CODE 4510-43-P
    MERIT SYSTEMS PROTECTION BOARD Public Availability of the Merit Systems Protection Board FY 2015 Service Contract Inventory AGENCY:

    Merit Systems Protection Board.

    ACTION:

    Notice.

    SUMMARY:

    The Merit Systems Protection Board (MSPB) is publishing this notice to advise the public of the availability of its FY 2015 Service Contract Inventory as required by the Consolidated Appropriations Act of 2010. This inventory provides information on service contract actions over $25,000 awarded in FY 2015. The inventory was developed in accordance with guidance issued on November 5, 2010 by the Office of Management and Budget's Office of Federal Procurement Policy (OFPP). The OFPP's guidance is available at: https://obamawhitehouse.archives.gov/sites/default/files/omb/procurement/memo/service-contract-inventories-guidance-11052010.pdf. The MSPB posted its inventory on its Web site at https://www.mspb.gov/contact/contracting.htm.

    FOR FURTHER INFORMATION CONTACT:

    Cynthia Richardson, Contracting Officer, Office of Finance and Administrative Management, Merit Systems Protection Board, 1615 M Street NW., Washington, DC 20419; telephone 202-254-4408; email [email protected]

    Jennifer Everling, Acting Clerk of the Board.
    [FR Doc. 2017-24904 Filed 11-16-17; 8:45 am] BILLING CODE 7400-01-P
    NATIONAL FOUNDATION OF THE ARTS AND THE HUMANITIES Sunshine Act Meeting of the National Museum and Library Services Board AGENCY:

    Institute of Museum and Library Services (IMLS), NFAH.

    ACTION:

    Notice of meeting.

    SUMMARY:

    This notice sets forth the agenda of the forthcoming meeting of the National Museum and Library Services Board. This notice also describes the function of the Board. Notice of the meeting is required under the Sunshine in Government Act.

    DATE AND TIME:

    Thursday, November 30 2017, from 9:00 a.m. to 12:15 p.m. and 1:15 p.m. to 2:30 p.m. EST

    Agenda: Thirty-Sixth Meeting of the National Museum and Library Service Board Meeting: 9:00 a.m.-12:15 p.m. Thirty-Sixth Meeting of the National Museum and Library Service Board Meeting:

    I. Welcome and Director's Report II. Approval of Minutes III. Program Speaker IV. Financial and Operations Report V. Office of Museum Services Report VI. Office of Library Report VII. Office of Digital and Information Strategy Report VIII. Special Report—Office of Communications IX. Adjourn (Open to the Public) 1:15 p.m. to 2:30 p.m.—Executive Session (Closed to the Public) PLACE:

    The meeting will be held at the IMLS Offices, Panel Room, Suite 4000, 955 L'Enfant Plaza North SW., Washington, DC 20024

    FOR FURTHER INFORMATION CONTACT:

    Katherine Maas, Program Specialist, Institute of Museum and Library Services, Suite 4000, 955 L'Enfant Plaza North SW., Washington, DC 20024. Telephone: (202) 653-4798.

    SUPPLEMENTARY INFORMATION:

    The National Museum and Library Services Board, which advises the Director of the Institute of Museum and Library Services on general policies with respect to the duties, powers, and authority of the Institute relating to museum, library and information services, will meet on November 30, 2017. The Thirty-Sixth Meeting on Thursday, November 30, 2017, from 9:00 a.m. to 12:15 p.m., is open to the public. The Executive Session, which will be held from 1:15-2:30 p.m., will be closed pursuant to subsections (c)(4) and (c)(9) of section 552b of Title 5, United States Code because the Board will consider information that may disclose: Trade secrets and commercial or financial information obtained from a person and privileges or confidential; and information the premature disclosure of which would be likely to significantly frustrate implementation of a proposed agency action.

    If you need special accommodations due to a disability, please contact: Institute of Museum and Library Services, 955 L'Enfant Plaza North SW., Suite 4000, Washington, DC 20024, Telephone: (202) 653-4796, at least seven (7) days prior to the meeting date.

    Dated: November 15, 2017. Danette Hensley, Staff Assistant, Office of General Counsel.
    [FR Doc. 2017-25108 Filed 11-15-17; 4:15 pm] BILLING CODE 7036-01-P
    NATIONAL SCIENCE FOUNDATION Advisory Committee for Integrative Activities: Notice of Meeting

    In accordance with the Federal Advisory Committee Act (Pub. L. 92-463, as amended), the National Science Foundation (NSF) announces the following meeting:

    NAME AND COMMITTEE CODE:

    Advisory Committee for Integrative Activities (#1373).

    DATES AND TIMES:

    December 13, 2017; 9:00 a.m.-5:00.p.m. December 14, 2017; 8:00 a.m.-5:00 p.m. PLACE:

    National Science Foundation, 2415 Eisenhower Avenue, Alexandria, VA 22314.

    To help facilitate your entry into the building, please contact Dr. Bernice Anderson via email at [email protected] or by phone: 703.292.8040 on or prior to December 12, 2017.

    TYPE OF MEETING:

    Part-Open.

    CONTACT PERSON:

    Dr. Bernice Anderson, Senior Advisor, Office of Integrative Activities (OIA), Room W17124, National Science Foundation, 2415 Eisenhower Avenue, Alexandria, VA 22314. Contact Information: 703-292-8040/[email protected].

    PURPOSE OF MEETING:

    To provide advice and recommendations concerning the use of and the need for the Science and Technology Policy Institute.

    Agenda Wednesday, December 13, 2017 • 9:30 a.m.-Noon (Open): Welcome, Charge to the Panel, Overview and History of the Science and Technology Policy Institute (STPI), and STPI Research Presentation • 1:30 p.m.-4:30 p.m. (Open): Presentation and Briefings by the Office of Science and Technology Representatives; Discussions about the Need for and Use of STPI Thursday, December 14, 2017 • 9:00 a.m.-11:30 a.m.: (Open)—Presentations/Briefings by NSF and other Government Clients • 11:30 a.m.-5:00 p.m.: (Closed) Review of the Contract and Report Writing REASON FOR CLOSING:

    The contract being reviewed includes information of a proprietary or confidential nature, including technical and personal information that must be considered in the evaluation and the development of recommendation(s). These matters are exempt under 5 U.S.C. 552b(c), (4), (6) and (9)(B) of the Government in the Sunshine Act.

    Dated: November 14, 2017. Crystal Robinson, Committee Management Officer.
    [FR Doc. 2017-24993 Filed 11-16-17; 8:45 am] BILLING CODE 7555-01-P
    NUCLEAR REGULATORY COMMISSION [NRC-2017-0127] Information Collection: Licenses and Radiation Safety Requirements for Irradiators AGENCY:

    Nuclear Regulatory Commission.

    ACTION:

    Notice of submission to the Office of Management and Budget; request for comment.

    SUMMARY:

    The U.S. Nuclear Regulatory Commission (NRC) has recently submitted a request for a renewal of an existing collection of information to the Office of Management and Budget (OMB) for review. The information collection is entitled, “Licenses and Radiation Safety Requirements for Irradiators.”

    DATES:

    Submit comments by December 18, 2017.

    ADDRESSES:

    Submit comments directly to the OMB reviewer at: Brandon De Bruhl, Desk Officer, Office of Information and Regulatory Affairs (OMB 3150-0158), NEOB-10202, Office of Management and Budget, Washington, DC 20503; telephone: 202-395-0710, email: [email protected]

    FOR FURTHER INFORMATION CONTACT:

    David Cullison, NRC Clearance Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-2084; email: [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Obtaining Information and Submitting Comments A. Obtaining Information

    Please refer to Docket ID NRC-2017-0127 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:

    Federal Rulemaking Web Site: Go to http://www.regulations.gov and search for Docket ID NRC-2017-0127.

    NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly-available documents online in the ADAMS Public Documents collection at http://www.nrc.gov/reading-rm/adams.html. To begin the search, select “ADAMS Public Documents” and then select “Begin Web-based ADAMS Search.” For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-4737, or by email to [email protected] The supporting statement is available in ADAMS under Accession No. ML17276B478.

    NRC's PDR: You may examine and purchase copies of public documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852.

    NRC's Clearance Officer: A copy of the collection of information and related instructions may be obtained without charge by contacting the NRC's Clearance Officer, David Cullison, Office of the Chief Information Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-2084; email: [email protected]

    B. Submitting Comments

    The NRC cautions you not to include identifying or contact information in comment submissions that you do not want to be publicly disclosed in your comment submission. All comment submissions are posted at http://www.regulations.gov and entered into ADAMS. Comment submissions are not routinely edited to remove identifying or contact information.

    If you are requesting or aggregating comments from other persons for submission to the OMB, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment submissions into ADAMS.

    II. Background

    Under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the NRC recently submitted a request for renewal of an existing collection of information to OMB for review entitled, “Licenses and Radiation Safety Requirements for Irradiators.” The NRC hereby informs potential respondents that an agency may not conduct or sponsor, and that a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

    The NRC published a Federal Register notice with a 60-day comment period on this information collection on July 27, 2017 (82 FR 34994).

    1. The title of the information collection: 10 CFR part 36 “Licenses and Radiation Safety Requirements for Irradiators.”

    2. OMB approval number: 3150-0158.

    3. Type of submission: Extension.

    4. The form number if applicable: N/A.

    5. How often the collection is required or requested: Applications for new licenses and amendments may be submitted at any time (on occasion). Applications for renewal are submitted every 10 years. Reports are submitted as events occur.

    6. Who will be required or asked to respond: Applicant for and holders of specific licenses authorizing the use of licensed radioactive material for irradiators.

    7. The estimated number of annual responses: 2,389.

    8. The estimated number of annual respondents: 70.

    9. An estimate of the total number of hours needed annually to comply with the information collection requirement or request: 42,612.

    10. Abstract: Part 39 of title 10 of the Code of Federal Regulations (10 CFR), establishes radiation safety requirements for the use of radioactive material for irradiators. The information in the applications, reports and records is used by the NRC staff to ensure that the health and safety of the public is protected and that the licensee possession and use of source or byproduct material is in compliance with license and regulatory requirements.

    Dated at Rockville, Maryland, this 13th day of November, 2017.

    For the Nuclear Regulatory Commission.

    David Cullison, NRC Clearance Officer, Office of the Chief Information Officer.
    Subject: Information Collection: Licenses and Radiation Safety Requirements for Irradiators ADAMS Accession No. ML17276B480 (FRN)

    To receive a copy of this document, indicate in the box: “C” = Copy without attachment/enclosure “E” = Copy with attachment/enclosure “N” = No copy

    OFFICE NMSS N NMSS OCIO NAME Lymari Sepulveda Hipolito Gonzalez DATE 10/03/2017 10/3/2017 11/13/2017 OFFICIAL RECORD COPY
    [FR Doc. 2017-24987 Filed 11-16-17; 8:45 am] BILLING CODE 7590-01-P
    POSTAL REGULATORY COMMISSION [Docket Nos. CP2017-55; MC2018-22 and CP2018-44; MC2018-23 and CP2018-45; MC2018-24 and CP2018-46; CP2018-47] New Postal Products AGENCY:

    Postal Regulatory Commission.

    ACTION:

    Notice.

    SUMMARY:

    The Commission is noticing a recent Postal Service filing for the Commission's consideration concerning negotiated service agreements. This notice informs the public of the filing, invites public comment, and takes other administrative steps.

    DATES:

    Comments are due: November 20, 2017.

    ADDRESSES:

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

    FOR FURTHER INFORMATION CONTACT:

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

    SUPPLEMENTARY INFORMATION:

    Table of Contents I. Introduction II. Docketed Proceeding(s) I. Introduction

    The Commission gives notice that the Postal Service filed request(s) for the Commission to consider matters related to negotiated service agreement(s). The request(s) may propose the addition or removal of a negotiated service agreement from the market dominant or the competitive product list, or the modification of an existing product currently appearing on the market dominant or the competitive product list.

    Section II identifies the docket number(s) associated with each Postal Service request, the title of each Postal Service request, the request's acceptance date, and the authority cited by the Postal Service for each request. For each request, the Commission appoints an officer of the Commission to represent the interests of the general public in the proceeding, pursuant to 39 U.S.C. 505 (Public Representative). Section II also establishes comment deadline(s) pertaining to each request.

    The public portions of the Postal Service's request(s) can be accessed via the Commission's Web site (http://www.prc.gov). Non-public portions of the Postal Service's request(s), if any, can be accessed through compliance with the requirements of 39 CFR 3007.40.

    The Commission invites comments on whether the Postal Service's request(s) in the captioned docket(s) are consistent with the policies of title 39. For request(s) that the Postal Service states concern market dominant product(s), applicable statutory and regulatory requirements include 39 U.S.C. 3622, 39 U.S.C. 3642, 39 CFR part 3010, and 39 CFR part 3020, subpart B. For request(s) that the Postal Service states concern competitive product(s), applicable statutory and regulatory requirements include 39 U.S.C. 3632, 39 U.S.C. 3633, 39 U.S.C. 3642, 39 CFR part 3015, and 39 CFR part 3020, subpart B. Comment deadline(s) for each request appear in section II.

    II. Docketed Proceeding(s)

    1. Docket No(s).: CP2017-55; Filing Title: USPS Notice of Change in Prices Pursuant to Amendment to Priority Mail Contract 263; Filing Acceptance Date: November 9, 2017; Filing Authority: 39 CFR 3015.5; Public Representative: Katalin K. Clendenin; Comments Due: November 20, 2017.

    2. Docket No(s).: MC2018-22 and CP2018-44; Filing Title: USPS Request to Add Priority Mail Contract 373 to Competitive Product List and Notice of Filing Materials Under Seal; Filing Acceptance Date: November 9, 2017; Filing Authority: 39 U.S.C. 3642 and 39 CFR 3020.30 et seq.; Public Representative: Timothy J. Schwuchow; Comments Due: November 20, 2017.

    3. Docket No(s).: MC2018-23 and CP2018-45; Filing Title: USPS Request to Add Priority Mail Contract 374 to Competitive Product List and Notice of Filing Materials Under Seal; Filing Acceptance Date: November 9, 2017; Filing Authority: 39 U.S.C. 3642 and 39 CFR 3020.30 et seq.; Public Representative: Timothy J. Schwuchow; Comments Due: November 20, 2017.

    4. Docket No(s).: MC2018-24 and CP2018-46; Filing Title: USPS Request to Add Priority Mail Express, Priority Mail & First-Class Package Service Contract 26 to Competitive Product List and Notice of Filing Materials Under Seal; Filing Acceptance Date: November 9, 2017; Filing Authority: 39 U.S.C. 3642 and 39 CFR 3020.30 et seq.; Public Representative: Timothy J. Schwuchow; Comments Due: November 20, 2017.

    5. Docket No(s).: CP2018-47; Filing Title: Notice of United States Postal Service of Filing a Functionally Equivalent Global Expedited Package Services 9 Negotiated Service Agreement and Application for Non-Public Treatment of Materials Filed Under Seal; Filing Acceptance Date: November 9, 2017; Filing Authority: 39 CFR 3015.5; Public Representative: Katalin K. Clendenin; Comments Due: November 20, 2017.

    This notice will be published in the Federal Register.

    Stacy L. Ruble, Secretary.
    [FR Doc. 2017-24906 Filed 11-16-17; 8:45 am] BILLING CODE 7710-FW-P
    SECURITIES AND EXCHANGE COMMISSION Proposed Collection; Comment Request Upon Written Request, Copy Available From: Securities and Exchange Commission, Office of FOIA Services, 100 F Street NE., Washington, DC 20549-2736 Extension: Form N-CSR, SEC File No. 270-512, OMB Control No. 3235-0570

    Notice is hereby given that, pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange Commission (the “Commission”) is soliciting comments on the collection of information summarized below. The Commission plans to submit this existing collection of information to the Office of Management and Budget (“OMB”) for extension and approval.

    Form N-CSR (17 CFR 249.331 and 274.128) is a combined reporting form used by registered management investment companies (“funds”) to file certified shareholder reports under the Investment Company Act of 1940 (15 U.S.C. 80a-1 et seq.) (“Investment Company Act”) and the Securities Exchange Act of 1934 (15 U.S.C. 78a et seq.) (“Exchange Act”). Specifically, Form N-CSR is to be used for reports under section 30(b)(2) of the Investment Company Act (15 U.S.C. 80a-29(b)(2)) and section 13(a) or 15(d) of the Exchange Act (15 U.S.C. 78m(a) and 78o(d)), filed pursuant to rule 30b2-1(a) under the Investment Company Act (17 CFR 270.30b2-1(a)). Reports on Form N-CSR are to be filed with the Securities and Exchange Commission (“Commission”) no later than 10 days after the transmission to stockholders of any report that is required to be transmitted to stockholders under rule 30e-1 under the Investment Company Act (17 CFR 270.30e-1). The information filed with the Commission permits the verification of compliance with securities law requirements and assures the public availability and dissemination of the information.

    The current total annual burden hour inventory for Form N-CSR is 172,899 hours.1 The hour burden estimates for preparing and filing reports on Form N-CSR are based on the Commission's experience with the contents of the form. The number of burden hours may vary depending on, among other things, the complexity of the filing and whether preparation of the reports is performed by internal staff or outside counsel.

    1 This estimate is based on the following calculations: 172,899 hours = (11,856 management investment companies × 14.52 hour burden per fund per year) + 750 additional hours for closed-end funds.

    The Commission's new estimate of burden hours that will be imposed by Form N-CSR is as follows:

    Hour Burden for Reports on Form N-CSR Number of funds 2 11,856 Number of filings per fund per year 2 Hour burden per fund per filing 7.31 Hour burden per fund per year (7.31 hours per filing × 2 filings per year) 14.62 Additional aggregate annual burden for closed-end funds 3 750 Total annual hour burden for all funds 4 174,085

    In total, the Commission estimates it will take 174,085 burden hours per year for all funds to prepare and file reports on Form N-CSR. Based on the Commission's estimate of 174,085 burden hours and an estimated wage rate of approximately $324 per hour,5 the total internal annual cost to registrants of the hour burden for complying with Form N-CSR requirements is approximately $56 million.6

    2 This estimate is based on the following calculation: 11,856 management investment companies = (1,594 exchange-traded funds—eight organized as unit investment trusts + 750 closed-end funds + 481 money market funds + 9,039 other mutual funds).

    3 This estimate is based on the following calculation: 750 hours = (750 closed-end funds × 1 hour per closed-end fund).

    4 This estimate is based on the following calculation: 174,085 hours = 750 hours + (11,856 funds × 14.62 burden hours per fund per year).

    5 The Commission's estimate concerning the wage rate is based on salary information for the securities industry compiled by the Securities Industry and Financial Markets Association. The estimated wage figure is based on published rates for compliance attorneys and senior programmers, modified to account for an 1,800-hour work year and inflation; multiplied by 5.35 to account for bonuses, firm size, employee benefits, and overhead; and adjusted to account for the effects of inflation, yielding effective hourly rates of $340 and $308, respectively. See Securities Industry and Financial Markets Association, Report on Management & Professional Earnings in the Securities Industry 2013. We estimate that compliance attorneys and senior programmers would divide their time equally, yielding an estimated hourly wage rate of $324. ($340 per hour for compliance attorneys + $308 per hour for senior programmers) ÷ 2 = $324 per hour.

    6 174,085 hours × $324 per hour = $56,403,540 per year.

    Estimates of average burden hours and costs are made solely for purposes of the Paperwork Reduction Act, and are not derived from a comprehensive or even representative survey or study of the costs of Commission rules and forms. Compliance with the information collection requirements of Form N-CSR is mandatory. Responses to the collection of information will not be kept confidential. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

    Written comments are invited on: (a) Whether the collection of information is necessary for the proper performance of the functions of the Commission, including whether the information has practical utility; (b) the accuracy of the Commission's estimate of the burden of the collection of information; (c) ways to enhance the quality, utility, and clarity of the information collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted in writing within 60 days of this publication.

    Please direct your written comments to Pamela Dyson, Chief Information Officer, Securities and Exchange Commission, c/o Remi Pavlik-Simon, 100 F Street NE., Washington, DC 20549; or send an email to: [email protected]

    Please direct your written comments to Pamela Dyson, Director/Chief Information Officer, Securities and Exchange Commission, C/O Remi Pavlik-Simon, 100 F Street NE., Washington, DC 20549; or send an email to: [email protected]

    Dated: November 14, 2017. Eduardo A. Aleman, Assistant Secretary.
    [FR Doc. 2017-24945 Filed 11-16-17; 8:45 am] BILLING CODE 8011-01-P
    SECURITIES AND EXCHANGE COMMISSION [Release No. 34-82063; File No. SR-ICEEU-2017-011] Self-Regulatory Organizations; ICE Clear Europe Limited; Notice of Filing of Proposed Rule Change, Security Based Swap Submission, or Advance Notice Relating to Amendments to the ICE Clear Europe Collateral and Haircut Policy November 13, 2017.

    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),1 and Rule 19b-4 thereunder,2 notice is hereby given that on November 2, 2017, ICE Clear Europe Limited (“ICE Clear Europe”) filed with the Securities and Exchange Commission (“Commission”) the proposed rule changes described in Items I, II, and III below, which Items have been primarily prepared by ICE Clear Europe. The Commission is publishing this notice to solicit comments on the proposed rule change from interested persons.

    1 15 U.S.C. 78s(b)(1).

    2 17 CFR 240.19b-4.

    I. Clearing Agency's Statement of the Terms of Substance of the Proposed Rule Change

    The principal purpose of the changes is to modify the ICE Clear Europe Collateral and Haircut Policy to incorporate certain changes to the calculation of absolute collateral limits for bonds provided as Permitted Cover by Clearing Members. The changes also make certain clarifications and updates and add certain general provisions addressing overall risk appetite and risk limits.

    II. Clearing Agency's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, ICE Clear Europe included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. ICE Clear Europe has prepared summaries, set forth in sections (A), (B), and (C) below, of the most significant aspects of such statements.

    (A) Clearing Agency's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change (a) Purpose

    ICE Clear Europe proposes revising its Collateral and Haircut Policy (the “Collateral and Haircut Policy”) to incorporate certain changes to the calculation of absolute collateral limits for bonds provided as Permitted Cover by Clearing Members and certain other revisions as described below. The amendments do not involve any changes to the ICE Clear Europe Clearing Rules or Procedures.

    The Collateral and Haircut Policy establishes a maximum amount of bonds from an individual issuer that ICE Clear Europe will accept from a Member Group (an “Absolute Limit”). The Absolute Limit is designed to take into account the trading liquidity of the bond, and accordingly the ability of ICE Clear Europe to liquidate the collateral when required. Currently, the underlying data used in the calculation of the Absolute Limit is based on the bi-annual International Capital Market Associate repo survey of market participants (the “ICMA Data”), as a proxy for secondary market trading activity. Under the revised Collateral and Haircut Policy, the Absolute Limit will be determined using actual secondary market trading volume data provided by ICE Data Services (the “IDS Data”). The IDS Data is compiled from a wide range of market data sources for transactions in government and corporate bonds. In certain circumstances where official trading volume data is published from a primary source, such as a governmental or central bank, such data will be used in lieu of the IDS Data. (For example, for bonds issued by Canada and Japan, ICE Clear Europe will utilize data provided by the Bank of Canada and the Japan Securities Dealers Association, respectively, instead of IDS Data.) In either case, the Absolute Limit for each bond issuer and collateral type will be 10% of the average daily volume over the past three months, rounded to the nearest million. ICE Clear Europe believes that the revised approach will provide a more direct and accurate estimation of liquidity than under the current approach, which will facilitate calculation of conservative and appropriate absolute concentration limits.

    The revisions also provide that in order to capture price volatility information on a conservative basis, the haircut calculation methodology, which incorporates a historical VaR model, among other factors, will use a two-sided VaR estimation based on the largest absolute returns.

    The Collateral and Haircut Policy has also been amended to more clearly take into account the existence of ICE Clear Europe's approximately U.S. $1 billion in committed repo facilities. As under the existing policy, in certain circumstances the Clearing House may permit a Clearing Member to maintain a collateral bond position in excess of normal absolute limits, in reliance on the Clearing House's ability to obtain cash for any excess securities using the committed repo facility. The amendments clarify that the repo facilities are available at any time there is an intra-day liquidity need, and are not limited to use in case of Clearing Member default.

    The amendments also note certain particular scenarios in which the clearing risk department may, consistent with the current policy, consider other qualitative and quantitative factors in setting prudent haircuts. These include the need to clean the bond price input data to remove spurious effects caused by changes in the different underlying bonds used to build bond price time-series. In this regard, the time series of bond price data in some instances may be spliced together from bonds with the same maturities but certain differences in other terms. These differences may cause the bonds to trade at different price levels, which could introduce spurious price spikes into the time series. To avoid an effect on the calculated haircut levels, ICE Clear Europe removes such spurious price spikes from the time series. The policy also notes that the clearing house may also need to consider the impact of unexpected currency de-pegging events on the calculation of cross-currency FX haircuts (such as the Swiss franc de-pegging from the Euro in January 2015, which caused unexpected sharp movements in the underlying exchange rate), as such events may not be fully captured by the quantitative approach in the Collateral and Haircut Policy.

    In addition, the Collateral and Haircut Policy has been revised to add certain general provisions, consistent with the approach taken in other ICE Clear Europe policies, addressing overall risk appetite and risk limits in the context of the purposes of the Collateral and Haircut Policy. Certain references in the policy to internal ICE Clear Europe personnel, departments and committees have been updated. The amendments also provide further detail as to the process for annual independent validation and governance oversight of relevant models used to support the Collateral and Haircut Policy. The policy owner, with the support of risk department personnel, will be responsible for the continuous review and reporting of the risk profile of the policy. The policy will be reviewed at least annually by the CDS and F&O Risk Committees and approved by the Board. Any material changes to the policy must be discussed with the Executive Risk Committee, reviewed by the CDS and F&O Risk Committees and the Board Risk Committee and approved by the Board. A “red-amber-green” escalation process has also been implemented to handle identified risks or situations as they arise.

    (b) Statutory Basis

    ICE Clear Europe believes that the changes described herein are consistent with the requirements of Section 17A of the Act 3 and the regulations thereunder applicable to it, including the standards under Rule 17Ad-22,4 and in particular are consistent with the prompt and accurate clearance of and settlement of securities transactions and, to the extent applicable, derivative agreements, contracts and transactions, the safeguarding of securities and funds in the custody or control of ICE Clear Europe or for which it is responsible and the protection of investors and the public interest, within the meaning of Section 17A(b)(3)(F) of the Act.5 The amendments are intended, among other matters, to adopt a more robust and direct method for obtaining relevant bond trading volume data that is used to determine concentration limits and to clarify certain other matters relating to calculation of haircuts and limits. The amendments also enhance the governance process around the Collateral and Haircut Policy. In ICE Clear Europe's view, the amendments will help ICE Clear Europe more clearly determine the liquidity of relevant bonds, which in turn will facilitate establishment of accurate concentration limits. As a result, ICE Clear Europe believes the amendments are consistent with the requirements of Section 17A(b)(3)(F) 6 of the Act. In addition, for the foregoing reasons, the amendments will facilitate setting and enforcing appropriately conservative haircuts and concentration limits, and provide for a review of the sufficiency of such haircuts and limits not less than annually, within the meaning of Rule 17Ad-22(e)(5).7

    3 15 U.S.C. 78q-1.

    4 17 CFR 240.17Ad-22.

    5 15 U.S.C. 78q-1(b)(3)(F).

    6 15 U.S.C. 78q-1(b)(3)(F).

    7 17 CFR 240.17Ad-22(e)(5).

    (B) Clearing Agency's Statement on Burden on Competition

    ICE Clear Europe does not believe the proposed changes to the rules would have any impact, or impose any burden, on competition not necessary or appropriate in furtherance of the purpose of the Act. ICE Clear Europe is adopting the amendments to the Collateral and Haircut Policy in order to enhance the calculations of concentration limits and haircuts and make certain other governance and related enhancements to the Collateral and Haircut Policy. The amendments will apply to all Clearing Members and products. ICE Clear Europe does not believe the amendments would materially affect the cost of clearing, adversely affect access to clearing in these products for Clearing Members or their customers, or otherwise adversely affect competition in clearing services. Although the amendments may change the haircuts or concentration limits for particular bonds, which may affect the costs and benefits of using those bonds as collateral, ICE Clear Europe believe that such changes are appropriate in light of the risk management enhancements provided by the revised policy. As a result, ICE Clear Europe believes that any impact or burden on competition from such amendments would be appropriate in furtherance of the purpose of the Act.

    (C) Clearing Agency's Statement on Comments on the Proposed Rule Change Received From Members, Participants or Others

    Written comments relating to the proposed changes to the rules have not been solicited or received. ICE Clear Europe will notify the Commission of any written comments received by ICE Clear Europe.

    III. Date of Effectiveness of the Proposed Rule Change and Timing for Commission Action

    Within 45 days of the date of publication of this notice in the Federal Register or within such longer period up to 90 days (i) as the Commission may designate if it finds such longer period to be appropriate and publishes its reasons for so finding or (ii) as to which the self-regulatory organization consents, the Commission will:

    (A) By order approve or disapprove the proposed rule change or

    (B) institute proceedings to determine whether the proposed rule change should be disapproved.

    IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:

    Electronic Comments

    • Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml) or

    • Send an email to [email protected] Please include File Number SR-ICEEU-2017-011 on the subject line.

    Paper Comments

    • Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.

    All submissions should refer to File Number SR-ICEEU-2017-011. This file number should be included on the subject line if email is used. To help the Commission process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all written statements with respect to the proposed rule change that are filed with the Commission, and all written communications relating to the proposed rule change between the Commission and any person, other than those that may be withheld from the public in accordance with the provisions of 5 U.S.C. 552, will be available for Web site viewing and printing in the Commission's Public Reference Room, 100 F Street NE., Washington, DC 20549, on official business days between the hours of 10:00 a.m. and 3:00 p.m. Copies of the filing also will be available for inspection and copying at the principal office of ICE Clear Europe and on ICE Clear Europe's Web site at https://www.theice.com/notices/Notices.shtml?regulatoryFilings.

    All comments received will be posted without change. Persons submitting comments are cautioned that we do not redact or edit personal identifying information from comment submissions. You should submit only information that you wish to make available publicly. All submissions should refer to File Number SR-ICEEU-2017-011 and should be submitted on or before December 8, 2017.

    8 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.8

    Eduardo A. Aleman, Assistant Secretary.
    [FR Doc. 2017-24935 Filed 11-16-17; 8:45 am] BILLING CODE 8011-01-P
    SECURITIES AND EXCHANGE COMMISSION [Release No. 34-82058; File No. SR-IEX-2017-39] Self-Regulatory Organizations: Investors Exchange LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Adopt Rules Pertaining to Certain Listing Regulatory Reporting and Operational Requirements November 13, 2017.

    Pursuant to Section 19(b)(1) 1 of the Securities Exchange Act of 1934 (the “Act”) 2 and Rule 19b-4 thereunder,3 notice is hereby given that on October 31, 2017, the Investors Exchange LLC (“IEX” or the “Exchange”) filed with the Securities and Exchange Commission (the “Commission”) the proposed rule change as described in Items I and II below, which Items have been prepared by the self-regulatory organization. The Commission is publishing this notice to solicit comments on the proposed rule change from interested persons.

    1 15 U.S.C. 78s(b)(1).

    2 15 U.S.C. 78a.

    3 17 CFR 240.19b-4.

    I. Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change

    Pursuant to the provisions of Section 19(b)(1) under the Securities Exchange Act of 1934 (“Act”),4 and Rule 19b-4 thereunder,5 Investors Exchange LLC (“IEX” or “Exchange”) is filing with the Commission a proposed rule change to adopt rules pertaining to certain listing regulatory reporting and operational requirements. The Exchange has designated this proposal as non-controversial and provided the Commission with the notice required by Rule 19b-4(f)(6)(iii) under the Act.6 The text of the proposed rule change is available at the Exchange's Web site at www.iextrading.com, at the principal office of the Exchange, and at the Commission's Public Reference Room.

    4 15 U.S.C. 78s(b)(1).

    5 17 CFR 240.19b-4.

    6 17 CFR 240.19b-4(f)(6)(iii).

    II. Self-Regulatory Organization's Statement of the Purpose of, and the Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statement [sic] may be examined at the places specified in Item IV below. The self-regulatory organization has prepared summaries, set forth in Sections A, B, and C below, of the most significant aspects of such statements.

    A. Self-Regulatory Organization's Statement of the Purpose of, and the Statutory Basis for, the Proposed Rule Change 1. Purpose

    On June 17, 2016 the Commission granted IEX's application for registration as a national securities exchange under Section 6 of the Act including approval of rules applicable to the qualification, listing and delisting of companies on the Exchange.7 The Exchange plans to begin a listing program in 2017 and is proposing to adopt rules pertaining to certain listing regulatory reporting and operational requirements, as described below.

    7See Securities Exchange Act Release No. 34-78101 (June 17, 2016), 81 FR 41141 (June 23, 2016) (File No. 10-222).

    Short-Interest Reporting

    The Financial Industry Regulatory Authority (“FINRA”), the Nasdaq Stock Market (“Nasdaq”) and the New York Stock Exchange (“NYSE”) each have rules requiring that members of such self-regulatory organization (“SRO”) record and report specified short positions in all customer and proprietary accounts.8 This data is also referred to as short interest. In the case of Nasdaq, the recording and reporting requirements apply to positions in securities listed on Nasdaq, while the FINRA and NYSE rules apply to all equity securities. The FINRA, Nasdaq and NYSE rules each require reporting on a bi-monthly basis by their member firms. FINRA, NYSE and Nasdaq firms provide their short position reports to FINRA through the Firm Gateway.9 Firms must report their mid-month short positions as of the close of business on the settlement date of the 15th of each month, or, where the 15th is a non-settlement date, on the preceding settlement date. Firms must report their end-of-month short positions as of the close of business on the last business day of the month on which transactions settle pursuant to FINRA and exchange rules. Both reports must be received by FINRA no later than the second business day after the reporting settlement date.

    8See FINRA Rule 4560, Nasdaq Rule 3360, and NYSE Rule 4560.

    9 FINRA members are required to report short interest positions through a web-based interface which is accessible via the Firm Gateway. See, Regulatory Notice 16-32 entitled “Short Interest Reporting” accessible at http://www.finra.org/sites/default/files/notice_doc_file_ref/Regulatory-Notice-16-32.pdf.

    FINRA consolidates the short position reports submitted by each firm, and provides such reports to the relevant listing exchange for each listed security (i.e., NYSE, Nasdaq and Bats BZX Exchange, Inc. (“Bats”)). In order to provide transparency 10 regarding aggregate short interest in equities securities, the listing exchanges publish the consolidated short interest data seven business days after the reporting settlement date. Similarly, FINRA publishes consolidated short interest data for securities that are not listed on an exchange on the same time frame. Short interest data is also used by FINRA for regulatory purposes, including to assess compliance with Regulation SHO.

    10 Short interest reporting and publication began in 1986 in connection with a study and recommendation by Irving M. Pollack (a former Commissioner of the SEC) on behalf of the National Association of Securities Dealers, Inc., the predecessor to FINRA.

    IEX proposes to adopt a comparable rule requiring short interest recording and reporting in securities listed on IEX by Members. Specifically, IEX proposes to adopt new Rule 3.293, entitled Short-Interest Reporting, that requires IEX Members, to the extent such information is not otherwise reported to FINRA in conformance with FINRA Rule 4560, to comply with FINRA Rule 4560 with respect to securities listed on IEX, as if such rule were part of IEX's rules, and to report required information in the form and manner specified by IEX. Thus, as proposed, IEX Members are subject to the following requirements:

    (a) Each Member shall maintain a record of total “short” positions in all customer and proprietary firm accounts in securities listed on IEX 11 and shall regularly report such information to FINRA in such a manner as may be prescribed by IEX. Reports shall be received by FINRA no later than the second business day after the reporting settlement date designated by IEX.

    11 FINRA Rule 4560(a) provides that the short interest recording and reporting requirements are not applicable to Restricted Equity Securities, as defined in FINRA Rule 6420 which further references the definition of “restricted security” in Rule 144(a)(3) under the Securities Act of 1933. Restricted securities are not eligible for listing on IEX since they are subject to trading restrictions, so this limitation is not necessary for inclusion in IEX Rule 3.293.

    (b) Members shall record and report all gross short positions existing in each individual firm or customer account, including the account of a broker-dealer, that resulted from (1) a “short sale”, as that term is defined in Rule 200(a) of SEC Regulation SHO, or (2) where the transaction(s) that caused the short position was marked “long,” consistent with SEC Regulation SHO, due to the firm's or the customer's net long position at the time of the transaction. Members shall report only those short positions resulting from short sales that have settled or reached settlement date by the close of the reporting settlement date designated by IEX.

    (c) The recording and reporting requirements shall not apply to:

    (1) Any sale by any person, for an account in which he has an interest, if such person owns the security sold and intends to deliver such security as soon as is possible without undue inconvenience or expense; and

    (2) any sale by an underwriter, or any member of a syndicate or group participating in the distribution of a security, in connection with an over-allotment of securities, or any lay-off sale by such a person in connection with a distribution of securities through rights or a standby underwriting commitment.

    While FINRA Rule 4560 requires such recording and reporting in all equity securities, not all IEX Members are also members of FINRA. Therefore, the Exchange believes that with the launch of its listing program, it is appropriate to add an IEX rule requiring recording and reporting of short interest positions in securities listed on IEX, so that IEX Members that are not FINRA members are subject to such requirements and their short positions in IEX listed securities will be consolidated for publication and available to FINRA for regulatory purposes.

    Further, as proposed, IEX Rule 3.293 specifies that information required to be reported pursuant to FINRA Rule 4560 shall be reported to IEX in the form and manner specified by IEX.12 As proposed, IEX Rule 3.293 is substantially similar to FINRA Rule 4560 except that Members are only required to record and report short positions in securities listed on IEX. This limitation is substantially similar to Nasdaq Rule 3360, which also limits short interest reporting to securities listed on Nasdaq.13

    12 IEX Members will use the FINRA Gateway to report short interest positions. IEX believes that virtually all IEX Members already have access to the FINRA Firm Gateway. To the extent there are any Members that do not already have access, FINRA will provide such Members with access to the Firm Gateway. Following effectiveness of this rule change, and prior to listing launch, IEX will disseminate a notice to Members advising of the reporting process and timelines.

    13See Nasdaq Rule 3360(a).

    Notification Requirements for Offering Participants

    SEC Regulation M is designed to prevent manipulation by individuals with an interest in the outcome of an offering of securities, and prohibits activities and conduct that could artificially influence the market for an offered security.14 Regulation M generally prohibits underwriters, broker-dealers, issuers and other persons participating in a distribution from directly or indirectly bidding for or purchasing the offered security (or inducing another person to do so) during the applicable “restricted period,” 15 which commences on the later of one or five business days prior to determination of the offering price 16 or such time that a person becomes a distribution participant, and ends upon such person's completion of participation in the distribution. Regulation M also governs certain market activities (i.e., stabilizing bids, syndicate covering transactions and penalty bids 17 ) in connection with an offering and requires that notification of such activity be provided to the SRO with direct authority over the principal market in the United States for the security for which the syndicate covering transaction is effected or the penalty bid is imposed. In the case of a stabilizing bid, such notice must be provided to the market on which the stabilizing bid will be posted. Further, Regulation M prohibits any person from selling short a security that is the subject of a public offering and purchasing the security in the offering, if the short sale was effected during the restricted period.

    14See Securities Exchange Act Release No. 38067 (December 20, 1996), 62 FR 520 (January 3, 1997) (File No. S7-11-96) (Anti-Manipulation Rules Concerning Securities Offerings; Final Rules). See also generally SEC Staff Legal Bulletin No. 9, Frequently Asked Questions About Regulation M (April 12, 2002 update) at https://www.sec.gov/interps/legal/mrslb9.htm.

    15 The term “restricted period” is defined in Rule 100(b) of Regulation M. See 17 CFR 242.100(b).

    16 The term “offering price” means the price at which the security is to be or is distributed. See 17 CFR 242.100(b).

    17See 17 CFR 242.100(b) (definitions of “stabilizing,” “syndicate covering transaction,” and “penalty bid”). Generally, a “stabilizing bid” is a bid that is intended to maintain the price of the offered security and is necessary to prevent or retard a decline in the security's price. A “penalty bid” allows a lead underwriter to reclaim a selling concession paid to a syndicate member if that member's customers sell their allocated shares in the immediate aftermarket. A “syndicate covering transaction” is generally defined as placing a bid or effecting a purchase to reduce a syndicate short position.

    IEX and FINRA are parties to a regulatory services agreement pursuant to which FINRA performs certain regulatory functions on behalf of IEX.18 IEX and FINRA also entered into an agreement to reduce regulatory duplication for IEX Members that are also members of FINRA whereby IEX has allocated certain regulatory responsibilities to FINRA pursuant to Rule 17d-2 under the Act.19 Compliance with Regulation M is included within the regulatory functions and responsibilities that FINRA performs with respect to IEX Members. As part of FINRA's program to monitor for compliance with Regulation M, FINRA reviews trading and quoting activity for prohibited purchases, bids or attempts to induce bids or purchases during the applicable restricted period and for prohibited short sales during the restricted period prior to the pricing of an offering. Thus, FINRA must receive pertinent distribution related information in a timely fashion to facilitate its review of IEX Members' compliance with Regulation M.

    18See IEX Rule 1.160(hh).

    19See Securities Exchange Act Release No. 78434 (July 28, 2016), 81 FR 51256 (August 3, 2016) (File No. 4-700).

    Accordingly, in preparation for becoming a listing market, the Exchange proposes to amend Rule 11.160, which is currently reserved, to adopt provisions requiring notification requirements for offering participants that are substantially identical to those specified in NYSE Rule 5190.20 As proposed, Rule 11.160 is entitled “Notification Requirements for Offering Participants” and includes the following provisions:

    20 Proposed IEX Rule 11.160 is also substantially similar to FINRA Rule 5190, except that the FINRA rule has a broader scope since the IEX rule applies only to offerings in securities listed on IEX, and minor terminology differences.

    • Paragraph (a) provides general information and states that IEX Rule 11.160 sets forth the notice requirements applicable to Members participating in offerings of listed securities for purposes of monitoring compliance with the provisions of SEC Regulation M. In addition, the paragraph notes that Members also must comply with all applicable rules governing the withdrawal of quotations in accordance with SEC Regulation M.

    • Paragraph (b) states that the terms shall have the meanings as set forth in Rules 100 and 101 of SEC Regulation M: “actively traded”, “affiliated purchaser”, “covered security”, “distribution”, “distribution participant”, “offering price”, “penalty bid”, “restricted period”, “selling security holder”, “stabilizing” and “syndicate covering transaction”.

    • Paragraph (c) is entitled “Notice Relating to Distributions of Listed Securities Subject to a Restricted Period Under SEC Regulation M” and sets forth the notification requirements applicable to distributions of listed securities that are “covered securities” 21 subject to a restricted period under Rule 101 or 102 of Regulation M. Required notices must be provided in such form as specified by the Exchange with respect to: The Member's determination as to whether a one-day or five-day restricted period applies under Rule 101 of Regulation M and the basis for such determination, including the contemplated date and time of the commencement of the restricted period, the listed security name and symbol, and identification of the distribution participants and affiliated purchasers, no later than the business day prior to the first complete trading session of the applicable restricted period, unless later notification is necessary under specific circumstances; the pricing of the distribution, including the listed security name and symbol, the type of security, the number of shares offered, the offering price, the last sale before the distribution, the pricing basis, the SEC effective date and time, the trade date, the restricted period, and identification of the distribution participants and affiliated purchasers, no later than the close of business the next business day following the pricing of the distribution, unless later notification is necessary under specific circumstances; and the cancellation or postponement of any distribution for which prior notification of commencement of the restricted period has been submitted under paragraph (c)(1)(A) of Rule 11.160, immediately upon the cancellation or postponement of such distribution. If no Member is acting as a manager (or in a similar capacity) of such distribution, then each Member that is a distribution participant or affiliated purchaser shall provide the notice required under paragraph (c)(1) of Rule 11.160, unless another Member has assumed responsibility in writing for compliance therewith. Paragraph (c) also provides that any Member that is an issuer or selling security holder in a distribution of any listed security that is a covered security subject to a restricted period under Rule 102 of SEC Regulation M shall comply with the notice requirements of paragraph (c)(1) Rule 11.160, unless another Member has assumed responsibility in writing for compliance therewith.

    21 The term “covered security” is defined in Rule 100(b) of Regulation M. See 17 CFR 242.100(b).

    • Paragraph (d) is entitled “Notice Relating to Distributions of “Actively Traded” Securities Under Regulation M” and sets forth the notification requirements applicable to distributions of any listed security that is considered an “actively traded” security under Rule 101 of Regulation M. Required notices must be provided in such form as specified by the Exchange with respect to: The Member's determination that no restricted period applies under Rule 101 of SEC Regulation M and the basis for such determination; and the pricing of the distribution, including the listed security name and symbol, the type of security, the number of shares offered, the offering price, the last sale before the distribution, the pricing basis, the SEC effective date and time, the trade date, and identification of the distribution participants and affiliated purchasers. Paragraph (d) also provides that such notice shall be provided no later than the close of business the next business day following the pricing of the distribution, unless later notification is necessary under specific circumstances. Further if no Member is acting as a manager (or in a similar capacity) of such distribution, then each Member that is a distribution participant or an affiliated purchaser shall provide the notice required, unless another Member has assumed responsibility in writing for compliance therewith.

    • Paragraph (e) is entitled “Notice of Stabilizing Bids, Penalty Bids and Syndicate Covering Transactions in Listed Securities” and sets forth the notification requirements for such activities. Required notices must be provided in such form as specified by the Exchange with respect to: The Member's intention to conduct such activity, prior to placing or transmitting the stabilizing bid, imposing the penalty bid or engaging in the first syndicate covering transaction, including identification of the listed security and its symbol and the date such activity will occur; and confirmation that the Member has placed or transmitted a stabilizing bid, imposed a penalty bid or engaged in a syndicate covering transaction, within one business day of completion of such activity, including identification of the listed security and its symbol, the total number of shares and the date(s) of such activity.

    All required notifications pursuant to IEX Rule 11.160 will be submitted by IEX Members to FINRA through the Firm Gateway.22 Upon effectiveness of this rule change and prior to the first IEX listing, the Exchange will disseminate a regulatory circular to Members advising of the form and manner for submission of required notifications through the FINRA Firm Gateway.

    22 Information regarding FINRA's Firm Gateway is available at: http://www.finra.org/sites/default/files/NoticeDocument/p125975.pdf. IEX believes that virtually all IEX Members that would be required to submit notifications pursuant to IEX Rule 11.160 already have access to the FINRA Firm Gateway. Generally, such Members must be members of FINRA in order to distribute shares to the public, unless such Member is an issuer or selling security holder in a distribution of a listed security pursuant to Rule 102 of Regulation M. To the extent there are any Members that fall into this exception, and do not already have access to the Firm Gateway, such Members will be provided with access to the Firm Gateway.

    Short Sale Circuit Breaker Restriction

    Rule 201 of Regulation SHO 23 provides for the imposition of a short sale circuit breaker, in a covered security by trading centers in the event that the price of a covered security 24 decreases by 10% or more from the covered security's closing price as determined by the listing market 25 for the covered security as of the end of regular trading hours 26 on the prior day. If the circuit breaker is triggered, paragraph (b)(1) of Rule 201 requires each trading center to establish, maintain, and enforce written policies and procedures reasonably designed to prevent the execution or display of a short sale order of a covered security at a price that is less than or equal to the current national best bid (subject to certain specified exceptions) for the remainder of the trading day on which it is triggered and the following day.

    23 17 CFR 242.201.

    24 17 CFR 242.201(a)(1).

    25 17 CFR 242.201(a)(3).

    26 17 CFR 242.201(a)(7).

    Paragraph (b)(3) of Rule 201 further provides that the listing market for a covered security shall determine whether the price of such covered security has decreased by 10% or more from the covered security's closing price as of the end of regular trading hours on the prior day, and, if such decrease has occurred shall immediately notify the single plan processor responsible for consolidation of information for the covered security pursuant to Rule 603(b) of Regulation NMS.27 The single plan processor must then disseminate this information, thereby triggering the short sale circuit breaker restriction.28

    27 17 CFR 242.603(b).

    28See, FAQ 1.3 of “Division of Trading and Markets: Responses to Frequently Asked Questions Concerning Rule 201 of Regulation SHO.”

    Accordingly, in preparation for becoming a listing market, the Exchange proposes to amend IEX Rule 11.290 to adopt provisions regarding the required determinations and processes related to the short sale circuit breaker. As proposed, paragraph (b) of IEX Rule 11.290 is amended to add “Trigger Price” as a defined term with respect to the existing description of the Short Sale Price Test. Paragraph (c) of IEX Rule 11.290 (which is currently reserved) is titled “Determination of Trigger Price” and provides that, for covered securities for which the Exchange is the listing market, the System 29 shall determine whether a transaction in a covered security has occurred at a Trigger Price 30 and shall immediately notify the responsible single plan processor. Further, the System will not calculate the Trigger Price of a covered security outside of the Regular Market Session,31 and, if a covered security did not trade on the Exchange on the prior trading day (due to a trading halt, trading suspension, or otherwise), the Exchange's determination of the Trigger Price shall be based on the last sale price on the Exchange for that security on the most recent day on which the security traded. In addition, the Exchange proposes to add provisions to paragraph (d)(1) of IEX Rule 11.290 to provide that the Exchange may lift the Short Sale Price Test 32 before the Short Sale Period 33 ends for securities for which the Exchange is the listing market if the Exchange determines pursuant to IEX Rule 11.270 that the triggering transaction was a clearly erroneous execution as soon as practicable following such determination. Further, the Exchange may also lift the Short Sale Price Test before the Short Sale Period ends, for a covered security for which the Exchange is the listing market, if the Exchange has been informed by another exchange or a self-regulatory organization (“SRO”) that a transaction in the covered security that occurred at the Trigger Price was a clearly erroneous execution, as determined by the rules of that exchange or SRO. Finally, proposed paragraph (d)(2) of IEX Rule 11.290 provides that if the Exchange determines that the prior day's closing price for a listed security is incorrect in the System and resulted in an incorrect determination of the Trigger Price, the Exchange may correct the prior day's closing price and lift the Short Sale Price Test before the Short Sale Period ends.

    29 The term “System” is defined in IEX Rule 1.160(nn).

    30See amendments to Rule 11.290(b).

    31See Rule 1.160(gg).

    32 The term “Short Sale Price Test” is defined in IEX Rule 11.290(b), and encompasses the restrictions of the short sale circuit breaker pursuant to Rule 201 of Regulation SHO. 17 CFR 242.201.

    33 The term “Short Sale Period” is defined in IEX Rule 11.290(d), and encompasses the duration of the short sale circuit breaker pursuant to Rule 201(b)(1)(ii) of Regulation SHO. 17 CFR 242.201(b)(1)(ii).

    As proposed, the amendments to IEX Rule 11.290 are substantially identical to Bats Rule 11.19.

    2. Statutory Basis

    IEX believes that the proposed rule change is consistent with the provisions of Section 6 of the Act, in general and with Sections 6(b) 34 of the Act in general, and furthers the objectives of Sections 6(b)(5) of the Act,35 in particular, in that it is designed to prevent fraudulent and manipulative acts and practices, to promote just and equitable principles of trade, to foster cooperation and coordination with persons engaged in facilitating transactions in securities, to remove impediments to and perfect the mechanism of a free and open market and a national market system and, in general, to protect investors and the public interest. The Exchange believes that the proposed rule change supports these objectives because it provides for certain listing regulatory reporting and operational requirements which are consistent with the public interest and the protection of investors.

    34 15 U.S.C. 78f.

    35 15 U.S.C. 78f(b)(5).

    Short-Interest Reporting

    The Exchange believes that it is consistent with the Act to require IEX Members to record and report short interest in securities listed on IEX, to the extent not otherwise reported to FINRA. As discussed in the Purpose section, recording and reporting of short interest provides transparency regarding aggregate short interest and is also used by FINRA for regulatory purposes, including to assess compliance with Regulation SHO. The Exchange believes that requiring short interest recording and reporting by IEX Members in securities listed on IEX is thus consistent with the public interest and the protection of investors in support of these objectives. Further, the Exchange believes that the requirement that all IEX Members record and report short interest is equitable and not unfairly discriminatory because the requirement will result in all IEX Members being subject to such requirements, regardless of whether such Member is a member of FINRA.

    The Exchange also notes that proposed Rule 3.293 is substantially identical to FINRA Rule 4560 and Nasdaq Rule 3360, as described in the Purpose section, and thus the Exchange does not believe it raises any new or novel issues not already considered by the Commission.

    Notification Requirements for Offering Participants

    The Exchange believes that it is consistent with the Act to require IEX Members that are offering participants to provide the specified notifications to IEX in such form as specified by IEX, which, as discussed in the Purpose section, will be to FINRA through the Firm Gateway. The Exchange believes that imposing the specified notification requirements, and specifying that notification be to FINRA through the Firm Gateway, is consistent with the public interest and the protection of investors, since FINRA must receive such notifications in order to monitor IEX Members and other market participants for compliance with Regulation M. As described in the Purpose section, as part of FINRA's program to monitor for compliance with Regulation M, and pursuant to IEX regulatory services agreement with FINRA and allocation to FINRA pursuant to Rule 17d-2 under the Act, FINRA reviews trading and quoting activity for prohibited purchases, bids or attempts to induce bids or purchases during the applicable restricted period and for prohibited short sales during the restricted period prior to the pricing of an offering. Thus, FINRA must receive pertinent distribution related information in a timely fashion to facilitate its review of IEX Members' compliance with Regulation M. Accordingly, IEX believes that requiring such notifications is consistent with the protection of investors and the public interest.

    Further, the Exchange believes that imposition of the notification requirements is equitable and not unfairly discriminatory because all IEX Members will be subject to such requirements in the same manner.

    The Exchange also notes that the proposed amendments to Rule 11.160 are substantially identical to those specified in NYSE Rule 5190 and substantially similar to FINRA Rule 5190, as described in the Purpose section, and thus the Exchange does not believe that the proposed amendments raise any new or novel issues not already considered by the Commission.

    Short Sale Circuit Breaker Restriction

    The Exchange believes that it is consistent with the Act to amend IEX Rule 11.290 to adopt provisions regarding the required determinations and processes related to the short sale circuit breaker, as required by Rule 201 of Regulation SHO, as described in the Purpose section. Further, the Exchange believes that the rule amendments are equitable and not unfairly discriminatory because such amendments will apply to all IEX Members in the same manner.

    The Exchange also believes that the rule amendments are consistent with the Act, since they are designed to encourage fair and orderly trading and markets. Additionally, as proposed the rule amendments are substantially identical to Bats Rule 11.19, and thus the Exchange does not believe that the proposed amendments raise any new or novel issues not already considered by the Commission.

    B. Self-Regulatory Organization's Statement on Burden on Competition

    IEX does not believe that the proposed rule change will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. As described in the Purpose and Statutory Basis sections, the proposed rule change effectuates listing regulatory reporting and operational requirements and is not designed to address or advance any competitive issues. To the contrary, the Exchange believes that the proposed rule change facilitates competition since it is designed to effectuate IEX's operation as a listing market thereby enhancing competition with the other listing markets.

    C. Self-Regulatory Organization's Statement on Comments on the Proposed Rule Change Received From Members, Participants, or Others

    Written comments were neither solicited nor received.

    III. Date of Effectiveness of the Proposed Rule Change and Timing for Commission Action

    Because the foregoing proposed rule change does not: (i) Significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A) of the Act 36 and Rule 19b-4(f)(6) thereunder.37

    36 15 U.S.C. 78s(b)(3)(A).

    37 17 CFR 240.19b-4(f)(6).

    A proposed rule change filed under Rule 19(b)-4(f)(6) normally does not become operative prior to 30 days after the date of the filing. However, pursuant to Rule 19b-4(f)(6)(iii), the Commission may designate a shorter time if such action is consistent with the protection of investors and the public interest.38 The Exchange has asked the Commission to waive the 30-day operative delay so that the proposal may become operative immediately upon filing. The Commission believes that waiving the 30-day operative delay is consistent with the protection of investors and the public interest because the proposed rule change is substantially identical to the rules of other self-regulatory organizations and thus raises no novel issues.39 Accordingly, the Commission hereby waives the 30-day operative delay and designates the proposed rule change as operative upon filing.40

    38 Rule 19b-4(f)(6) requires an SRO to give the Commission written notice of its intent to file the proposed rule change at least five business days prior to the -date of filing the proposed rule change, or such shorter time as designated by the Commission. See 17 CFR 240.19b-4(f)(6). The Exchange has satisfied this requirement.

    39See supra notes 12-13 and accompanying text and supra note 20 and accompanying text. See also Bats Rule 11.19.

    40 For purposes only of waiving the operative delay for this proposal, the Commission has considered the proposed rule's impact on efficiency, competition, and capital formation. See 15 U.S.C. 78c(f).

    At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings under Section 19(b)(2)(B) 41 of the Act to determine whether the proposed rule change should be approved or disapproved.

    41 15 U.S.C. 78s(b)(2)(B).

    IV. Solicitation of Comments

    Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:

    Electronic Comments

    • Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or

    • Send an email to [email protected] Please include File Number SR-IEX-2017-39 on the subject line.

    Paper Comments

    • Send paper comments in triplicate to Brent J. Fields, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.

    All submissions should refer to File Number SR-IEX-2017-39. This file number should be included in the subject line if email is used. To help the Commission process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all written statements with respect to the proposed rule change that are filed with the Commission, and all written communications relating to the proposed rule change between the Commission and any person, other than those that may be withheld from the public in accordance with the provisions of 5 U.S.C. 552, will be available for Web site viewing and printing in the Commission's Public Reference Section, 100 F Street NE., Washington, DC 20549-1090. Copies of the filing will also be available for inspection and copying at the principal office of the Exchange. All comments received will be posted without change. Persons submitting comments are cautioned that we do not redact or edit personal identifying information from comment submissions. You should submit only information that you wish to make available publicly. All submissions should refer to File Number SR-IEX-2017-39 and should be submitted on or before December 8, 2017.

    42 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.42

    Eduardo A. Aleman, Assistant Secretary.
    [FR Doc. 2017-24930 Filed 11-16-17; 8:45 am] BILLING CODE 8011-01-P
    SECURITIES AND EXCHANGE COMMISSION [Release No. 34-82056; File No. SR-OCC-2017-806] Self-Regulatory Organizations; The Options Clearing Corporation; Notice of Filing of Advance Notice Concerning Liquidity for Same-Day Settlement November 13, 2017.

    Pursuant to Section 806(e)(1) of Title VIII of the Dodd-Frank Wall Street Reform and Consumer Protection Act, entitled Payment, Clearing and Settlement Supervision Act of 2010 (“Clearing Supervision Act”) 1 and Rule 19b-4(n)(1)(i) of the Securities Exchange Act of 1934 (“Act”),2 notice is hereby given that on October 13, 2017, The Options Clearing Corporation (“OCC”) filed with the Securities and Exchange Commission (“Commission”) an advance notice as described in Items I, II and III below, which Items have been prepared by OCC. The Commission is publishing this notice to solicit comments on the advance notice from interested persons.

    1 12 U.S.C. 5465(e)(1).

    2 17 CFR 240.19b-4(n)(1)(i).

    I. Clearing Agency's Statement of the Terms of Substance of the Advance Notice

    This advance notice is filed in connection with a proposed change to modify the tools available to OCC in order to provide a mechanism for addressing the risks of liquidity shortfalls, specifically, in the extraordinary situation where OCC faces a liquidity need to meet its same-day settlement obligations as a result of a bank or securities or commodities clearing organization failing to achieve daily settlement.

    The proposed changes to OCC's By-Laws were submitted as Exhibit 5 of the filing.3 The proposed change is described in detail in Item 10 below. All terms with initial capitalization not defined herein have the same meaning as set forth in OCC's By-Laws and Rules.4

    3 OCC has filed a proposed rule change with the Commission in connection with the proposed change. See SR-OCC-2017-017.

    4 OCC's By-Laws and Rules can be found on OCC's public Web site: http://optionsclearing.com/about/publications/bylaws.jsp. Other terms not defined herein or in the OCC By-Laws and Rules can be found in the Rules & Procedures of NSCC (“NSCC Rules”), available at http://www.dtcc.com/~/media/Files/Downloads/legal/rules/nscc_rules.pdf, as the context implies.

    II. Clearing Agency's Statement of the Purpose of, and Statutory Basis for, the Advance Notice

    In its filing with the Commission, OCC included statements concerning the purpose of and basis for the advance notice and discussed any comments it received on the advance notice. The text of these statements may be examined at the places specified in Item IV below. OCC has prepared summaries, set forth in sections A and B below, of the most significant aspects of these statements.

    (A) Clearing Agency's Statement on Comments on the Advance Notice Received From Members, Participants or Others

    Written comments were not and are not intended to be solicited with respect to the proposed change and none have been received. OCC will notify the Commission of any written comments received by OCC.

    (B) Advance Notices Filed Pursuant to Section 806(e) of the Payment, Clearing, and Settlement Supervision Act Description of the Proposed Change

    The purpose of the proposed change is to modify the tools available to OCC in order to provide a mechanism for addressing the risks of liquidity shortfalls, specifically, in the extraordinary situation where OCC faces a liquidity need to meet its same-day settlement obligations as a result of a bank or securities or commodities clearing organization failing to achieve daily settlement.

    Current Practice

    Presently, Article VIII, Section 5(e) of OCC's By-Laws provides OCC with the authority to borrow against the Clearing Fund in two circumstances. First, Article VIII, Section 5(e) of OCC's By-Laws provides OCC the authority to borrow where OCC “deems it necessary or advisable to borrow or otherwise obtain funds from third parties in order to meet obligations arising out of the default or suspension of a Clearing Member or any action taken by the Corporation in connection therewith pursuant to Chapter XI of the Rules or otherwise.” Second, Article VIII, Section 5(e) of OCC's By-Laws provides OCC the authority to borrow against the Clearing Fund where OCC “sustains a loss reimbursable out of the Clearing Fund pursuant to [Article VIII, Section 5(b) of OCC's By-Laws] but [OCC] elects to borrow or otherwise obtain funds from third parties in lieu of immediately charging such loss to the Clearing Fund.” In order for a loss to be reimbursable out of the Clearing Fund under Article VIII, Section 5(b) of OCC's By-Laws, it must arise from a situation in which any bank or securities or commodities clearing organization has failed “to perform any obligation to [OCC] when due because of its bankruptcy, insolvency, receivership, suspension of operations, or because of any similar event.” 5

    5 To the extent that a loss resulting from any of the events referred to in Article VIII, Section 5(b) is recoverable out of the Clearing Fund pursuant to Article VIII, Section 5(a), the provisions of Article VIII, Section 5(a) control and render the provisions of Article VIII, Section 5(b) inapplicable.

    Under either of the two aforementioned circumstances, OCC is authorized to borrow against the Clearing Fund for a period not to exceed 30 days, and during such period, the borrowing shall not affect the amount or timing of any charges otherwise required to be made against the Clearing Fund pursuant to Article VIII, Section 5. However, if any part of the borrowing remains outstanding after 30 days, then at the close of business on the 30th day (or the first Business Day thereafter) such amount must be considered an actual loss to the Clearing Fund, and OCC must immediately allocate such loss in accordance with Article VIII, Section 5.

    Proposed Change

    While Article VIII, Section 5(e) of OCC's By-Laws currently provides for borrowing authority in the more extreme scenarios involving a bank's or securities or commodities clearing organization's bankruptcy, insolvency, receivership, suspension of operations or similar event, such authority does not extend to the similar, but less extreme scenarios in which a bank or securities or commodities clearing organization might be temporarily unable to timely make daily settlement with OCC for reasons other than its bankruptcy, insolvency, receivership or suspension of operations or similar events. An example of such a related scenario would be a disruption of the ordinary operations of a settlement bank that temporarily prohibits the bank from timely effecting settlement payments in accordance with OCC's daily settlement cycle.

    The proposed change would expand upon the existing borrowing authority in Article VIII, Section 5(e) of OCC's By-Laws. As expanded, OCC would be authorized to borrow (or otherwise obtain funds through any means determined to be reasonable by the Executive Chairman, COO or CAO) against the Clearing Fund in the extraordinary event that OCC faces a liquidity need in order to complete same-day settlement. As specified in the proposed rule text, the funds obtained from any such transaction can be used only for their stated purpose, namely, to satisfy a need for liquidity for same-day settlement. Consistent with the existing borrowing authority in Article VIII, Section 5(e) of OCC's By-Laws, OCC would be authorized to borrow against the Clearing Fund for a period not to exceed 30 days, and during such period, the funds obtained would not be deemed to be charges against the Clearing Fund, irrespective of how such funds are applied, and the borrowing shall not affect the amount or timing of any charges otherwise required to be made against the Clearing Fund pursuant to Article VIII, Section 5. However, in the unlikely event that any part of the borrowing were to remain outstanding after 30 days, then at the close of business on the 30th day (or the first Business Day thereafter), such amount would be considered an actual loss to the Clearing Fund, and OCC must immediately allocate such loss in accordance with Article VIII, Section 5.

    Like the existing borrowing authority in Article VIII, Section 5(e) of OCC's By-Laws, OCC envisions that the proposed expanded authority only would be relevant in extraordinary circumstances and, even then, only would be used where OCC, exercising its discretion, believes the employment of this particular authority would be appropriate to address OCC's immediate liquidity need.

    OCC proposes to amend Sections 1(a), 5(b) and 5(e) of Article VIII of its By-Laws in order to give effect to the expanded borrowing authority discussed herein. Section 5(e) of Article VIII of OCC's By-Laws would be amended to permit OCC to borrow against the Clearing Fund if it reasonably believes such borrowing is necessary to meet its liquidity needs for same-day settlement as a result of the failure of any bank or securities or commodities clearing organization to achieve daily settlement.

    Section 1(a) of Article VIII of OCC's By-Laws would be amended to include conforming changes that would reflect that the purpose of the Clearing Fund includes borrowing against the Clearing Fund as permitted under Section 5(e) of Article VIII of the By-Laws.

    Section 5(b) of Article VIII of the By-Laws would be amended to include conforming changes that would declare that any borrowing remaining outstanding for less than 30 days may be considered, in OCC's discretion, an actual loss and the amount of any such loss then shall be charged proportionately against all Clearing Members' computed contributions to the Clearing Fund as fixed at the time, and any borrowing remaining outstanding on the 30th day shall be considered an actual loss to the Clearing Fund and the amount of any such loss shall be charged proportionately against all Clearing Members' computed contributions to the Clearing Fund as fixed at the time. OCC proposes to include discretionary authority to declare any borrowing outstanding for less than 30 days as an actual loss chargeable against the Clearing Fund because the proposed borrowing authority is intended only to address same-day liquidity needs, and intended to be promptly repaid upon the bank's or securities or commodities clearing organization's resolution of the temporary disruption. In the unlikely circumstance that a disruption of a bank or securities or commodities clearing organization is not timely resolved, OCC may need to exercise its discretion to declare an actual loss, depending on the size of the borrowing, to ensure that OCC replenishes its “Cover 1” financial resources.6 The requirement to recognize any borrowing outstanding after 30 days as an actual loss chargeable against the Clearing Fund would be consistent with the requirements of the borrowing authority currently permitted by Section 5(e) of Article VIII of the By-Laws.

    6 “Cover 1” financial resources refers to the requirement that a CCA maintains financial resources sufficient to enable it to cover the “default of the participant family that would potentially cause the largest aggregate credit exposure for the [CCA] in extreme but plausible market conditions.” 17 CFR 240.17Ad-22(e)(7)(viii).

    Expected Effect on and Management of Risk

    OCC believes the proposed change would enable it to better manage the risks associated with the failure of a settlement bank or securities or commodities clearing organization's to achieve timely settlement. As noted above, OCC's By-Laws currently provide for borrowing authority in the more extreme scenarios involving a bank's or securities or commodities clearing organization's bankruptcy, insolvency, receivership, suspension of operations or similar event, such authority does not extend to the similar, but less extreme scenarios in which a bank or securities or commodities clearing organization might be temporarily unable to timely make daily settlement with OCC for reasons other than its bankruptcy, insolvency, receivership or suspension of operations or similar events. The proposed change would expand upon this existing borrowing authority to allow OCC to borrow (or otherwise obtain funds through any means determined to be reasonable by the Executive Chairman, COO or CAO) against the Clearing Fund in the extraordinary event that OCC faces a liquidity need in order to complete same-day settlement. As a result, the proposed change would enhance OCC's ability to manage its liquidity risks and ensure that it is able to continue making timely settlements in the event of such a disruption.

    As stated above, it is conceivable, though extremely unlikely, that a bank or securities or commodities clearing organization may fail to make timely settlement with OCC as a result of a temporary disruption to its ordinary operations. The proposed change would not alter this risk, but would provide OCC with a mechanism for addressing it, should such risk ever be realized. The proposed mechanism for addressing this risk—discretionary authority to borrow from the Clearing Fund—would require OCC's senior and executive management to exercise discretion and judiciousness and could, if ever deployed, present an arguably new, though very limited, risk to Clearing Members.

    Modifying OCC's existing authority to borrow against the Clearing Fund introduces a new, and potentially competing, demand on OCC's Clearing Fund resources in that any amount of Clearing Fund resources borrowed to address the failure of a bank or securities or commodities clearing organization to make timely settlement would subtract from the available resources to address other losses that could be charged against the Clearing Fund (most common among those, losses related to Clearing Member defaults). To manage the potential for competing demands on Clearing Fund resources, OCC would exercise discretion and judiciousness in selecting when this new borrowing authority could be prudently deployed, in light of then-existing facts and circumstances. In the alternative, OCC's could elect to deploy an alternative tool, such as OCC's ability to extend the settlement window under Rule 505, if such tool would be more appropriate given anticipated demands on Clearing Fund resources in light of then-existing facts and circumstances. Because of the low probability that a bank or securities or commodities clearing organization would suffer a temporary disruption to its ordinary operations that could threaten its ability to make timely settlement, and the extremely low probability that such a disruption would result in the bank or securities or commodities clearing organization actually failing to make timely settlement, OCC believes that the potential for competing demands on Clearing Fund resources can be managed sufficiently through the tools available in its default management rules, policies and procedures.7

    7 In addition, the bank or securities or commodities clearing organization would need to be in deficit for the settlement cycle in question in order for OCC to face an immediate liquidity need. Further, OCC must reasonably anticipate an imminent or near imminent failure by one or more Clearing Members for there to be a potential competing demand on Clearing Fund resources. OCC believes that the alignment of all of these occurrences represents an extraordinarily low probability occurrence.

    The proposed change could arguably present a new, though very limited, risk to Clearing Members in that OCC's authority to borrow against the Clearing Fund would be expanded, albeit slightly, to permit borrowing in a new scenario where a bank or securities or commodities clearing organization fails to make timely settlement (but otherwise is not in bankruptcy, insolvency, receivership, suspension of operations or a similar state). In order for Clearing Members to be impacted by this risk, a borrowing under the proposed authority would need to be declared an actual loss by OCC prior to 30 days lapsing or remain outstanding for 30 days, at which point, such amount would be considered an actual loss to the Clearing Fund, and OCC would be required to immediately allocate such loss in accordance with Article VIII, Section 5. However, given that the proposed borrowing authority is intended to be deployed to address immediate liquidity needs arising from temporary disruptions of the ordinary operation of a bank or securities or commodities clearing organization, OCC believes that it is extremely unlikely that any amount of any such borrowing ultimately would need to be declared as an actual loss in advance of 30 days or remain outstanding for a period of 30 days. If, however, any amount of any such borrowing in fact did remain outstanding for longer than expected, OCC believes there would be a high probability that the bank or securities or commodities clearing organization in question has actually failed, and therefore entered bankruptcy, insolvency, receivership, suspension of operations or a similar state—which events would have independently triggered the already-existing borrowing authority in Article VIII, Section 5(e).

    Consistency With the Clearing Supervision Act

    The stated purpose of the Clearing Supervision Act is to mitigate systemic risk in the financial system and promote financial stability by, among other things, promoting uniform risk management standards for systemically important financial market utilities and strengthening the liquidity of systemically important financial market utilities.8 Section 805(a)(2) of the Clearing Supervision Act 9 also authorizes the Commission to prescribe risk management standards for the payment, clearing and settlement activities of designated clearing entities, like OCC, for which the Commission is the supervisory agency. Section 805(b) of the Clearing Supervision Act 10 states that the objectives and principles for risk management standards prescribed under Section 805(a) shall be to:

    8 12 U.S.C. 5461(b).

    9 12 U.S.C. 5464(a)(2).

    10 12 U.S.C. 5464(b).

    • Promote robust risk management;

    • promote safety and soundness;

    • reduce systemic risks; and

    • support the stability of the broader financial system.

    The Commission has adopted risk management standards under Section 805(a)(2) of the Clearing Supervision Act and the Act in furtherance of these objectives and principles, including those standards adopted pursuant to the Commission rules cited below.11 For the reasons set forth below, OCC believes that the proposed change is consistent with the risk management standards promulgated under Section 805(a) of the Clearing Supervision Act.12

    11 17 CFR 240.17Ad-22. See Securities Exchange Act Release Nos. 68080 (October 22, 2012), 77 FR 66220 (November 2, 2012) (S7-08-11) (“Clearing Agency Standards”); 78961 (September 28, 2016), 81 FR 70786 (October 13, 2016) (S7-03-14) (“Standards for Covered Clearing Agencies”). The Standards for Covered Clearing Agencies became effective on December 12, 2016. OCC is a “covered clearing agency” as defined in Rule 17Ad-22(a)(5) and therefore is subject to section (e) of Rule 17Ad-22.

    12 12 U.S.C. 5464(b)(1) and (4).

    Rule 17Ad-22(e)(7)(viii) requires that a covered clearing agency (“CCA”) address foreseeable liquidity shortfalls that would not be covered by the CCA's liquid resources and seek to avoid unwinding, revoking, or delaying the same-day settlement of payment obligations.13 As stated above, OCC believes that it could be foreseeable, though extremely unlikely, that a bank or securities or commodities clearing organization may fail to make timely settlement with OCC as the result of an event that does not result in a loss to OCC from the bankruptcy, insolvency, resolution, suspension of operations or similar event of such bank or securities or commodities clearing organization. The proposed change would improve OCC's ability to address such situations by expanding OCC's borrowing authority to enable OCC to borrow against the Clearing Fund in order to avoid disrupting its ordinary settlement cycle (and thusly, to avoid imposing the same disruption on Clearing Members).

    13 17 CFR 240.17Ad-22(e)(7)(viii).

    III. Date of Effectiveness of the Advance Notice and Timing for Commission Action

    The proposed change may be implemented if the Commission does not object to the proposed change within 60 days of the later of (i) the date the proposed change was filed with the Commission or (ii) the date any additional information requested by the Commission is received. OCC shall not implement the proposed change if the Commission has any objection to the proposed change.

    The Commission may extend the period for review by an additional 60 days if the proposed change raises novel or complex issues, subject to the Commission providing the clearing agency with prompt written notice of the extension. A proposed change may be implemented in less than 60 days from the date the advance notice is filed, or the date further information requested by the Commission is received, if the Commission notifies the clearing agency in writing that it does not object to the proposed change and authorizes the clearing agency to implement the proposed change on an earlier date, subject to any conditions imposed by the Commission.

    OCC shall post notice on its Web site of proposed changes that are implemented.

    The proposal shall not take effect until all regulatory actions required with respect to the proposal are completed.

    IV. Solicitation of Comments

    Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the advance notice is consistent with the Clearing Supervision Act. Comments may be submitted by any of the following methods:

    Electronic Comments

    • Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or

    • Send an email to [email protected] Please include File Number SR-OCC-2017-806 on the subject line.

    Paper Comments

    • Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549.

    All submissions should refer to File Number SR-OCC-2017-806. This file number should be included on the subject line if email is used. To help the Commission process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all written statements with respect to the advance notice that are filed with the Commission, and all written communications relating to the advance notice between the Commission and any person, other than those that may be withheld from the public in accordance with the provisions of 5 U.S.C. 552, will be available for Web site viewing and printing in the Commission's Public Reference Room, 100 F Street NE., Washington, DC 20549 on official business days between the hours of 10:00 a.m. and 3:00 p.m. Copies of the filing also will be available for inspection and copying at the principal office of OCC and on OCC's Web site at http://www.theocc.com/components/docs/legal/rules_and_bylaws/sr_occ_17_806.pdf.

    All comments received will be posted without change. Persons submitting comments are cautioned that we do not redact or edit personal identifying information from comment submissions. You should submit only information that you wish to make available publicly.

    All submissions should refer to File Number SR-OCC-2017-806 and should be submitted on or before December 8, 2017.

    By the Commission.

    Eduardo A. Aleman, Assistant Secretary.
    [FR Doc. 2017-24920 Filed 11-16-17; 8:45 am] BILLING CODE 8011-01-P
    SECURITIES AND EXCHANGE COMMISSION [Release No. 34-82066; File No. SR-NYSEArca-2017-85] Self-Regulatory Organizations; NYSEArca, Inc.; Notice of Filing of Amendment No. 3, and Order Granting Accelerated Approval of a Proposed Rule Change, as Modified by Amendment No. 3, To Amend NYSE Arca Rule 8.700-E and To List and Trade Shares of the ProShares European Volatility Futures ETF November 13, 2017. I. Introduction

    On July 28, 2017, NYSE Arca, Inc. (“NYSE Arca” or “Exchange”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”) 1 and Rule 19b-4 thereunder,2 a proposed rule change to: (1) Amend NYSE Arca Rule 8.700-E to expand the list of financial instruments that may be held by a trust that issues Managed Trust Securities; and (2) to list and trade shares (“Shares”) of the ProShares European Volatility Futures ETF (“Fund”) under proposed amended NYSE Arca Rule 8.700-E. The proposed rule change was published for comment in the Federal Register on August 16, 2017.3 On September 21, 2017, the Exchange filed Amendment No. 1 to the proposed rule change, which amended and replaced the original filing in its entirety. On September 26, 2017, pursuant to Section 19(b)(2) of the Act,4 the Commission designated a longer period within which to either approve the proposed rule change, disapprove the proposed rule change, or institute proceedings to determine whether to disapprove the proposed rule change.5 On November 2, 2017, the Exchange filed Amendment No. 2 to the proposed rule change, which amended and replaced in its entirety the proposed rule change as modified by Amendment No. 1. On November 9, 2017, the Exchange filed Amendment No. 3 to the proposed rule change.6 The Commission has received no comments on the proposed rule change. The Commission is publishing this notice to solicit comments on Amendment No. 3 from interested persons, and is approving the proposed rule change, as modified by Amendment No. 3 on an accelerated basis.

    1 15 U.S.C. 78s(b)(1).

    2 17 CFR 240.19b-4.

    3See Securities Exchange Act Release No. 81373 (August 10, 2017), 82 FR 38973.

    4 15 U.S.C. 78s(b)(2).

    5See Securities Exchange Act Release No. 81721, 82 FR 45922 (October 2, 2017) (designating November 11, 2017 as the date by which the Commission will approve the proposed rule change, disapprove the proposed rule change, or institute proceedings to determine whether to disapprove the proposed rule change).

    6 In Amendment No. 3, the Exchange: (1) Represented that the EURO STOXX 50 Volatility Index (“VSTOXX”) levels will be widely disseminated by major market data vendors on a real-time basis throughout each trading day; (2) expanded its representation regarding when the sponsor would erect a “fire wall” to include the circumstance where the sponsor becomes a broker-dealer and represented that the sponsor will maintain the “fire wall” it implemented regarding access to information concerning the composition and/or changes to the Fund's portfolio; (3) narrowed the list of the Fund's permitted investments to exclude forwards; (4) described the Fund's policies concerning swap counterparties; (5) analyzed the impacts on arbitrage of the 9 a.m. Eastern Time creation and redemption order deadline and 11:30 a.m. Eastern Time net asset value (“NAV”) calculation time; (6) represented that, to the extent that the sponsor permits an exchange of a futures contract for a related position or block trade with the Fund, such transactions will be effected on that day in the same manner for all authorized participants; (7) supplemented its description of the Fund's NAV calculation methodology and the availability of price information for the Fund's permitted investments; (8) modified its description of the Indicative Optimized Portfolio Value (“IOPV”) methodology; (9) provided information regarding the dissemination of the NAV and the availability of pricing for the EURO STOXX 50 Index (“Index”), VSTOXX, and the Fund's benchmark; (10) represented that its surveillance procedures are adequate to continue to properly monitor the trading of the Managed Trust Securities that hold futures on VSTOXX (“Futures Contracts”) and/or swaps on VSTOXX in all trading sessions and to deter and detect violations of Exchange rules; (11) clarified where Futures Contracts are listed; (12) clarified the Fund's primary investment objective; and (13) made certain technical changes. Amendment No. 3 is available on the Commission's Web site at: https://www.sec.gov/comments/sr-nysearca-2017-85/nysearca201785-2678502-161479.pdf.

    II. Summary of the Proposed Rule Change, as Modified by Amendment No. 3 7

    7 Additional information regarding the Shares and the Trust, including investment strategies, risks, NAV calculation, creation and redemption procedures, fees, Trust (as defined herein) holdings, and taxes, among other information, is included in Amendment No. 3, supra note 7, and the Registration Statement, infra note 12.

    The Exchange proposes to amend NYSE Arca Rule 8.700-E to add the VSTOXX as a reference asset to the futures contracts and swaps that may be held by trusts that issue Managed Trust Securities.8 NYSE Arca Rule 8.700-E governs the listing and trading of Managed Trust Securities on the Exchange. Additionally, the Exchange proposes to list and trade the Shares under the proposed rule.

    8 Managed Trust Security is a security that is registered under the Securities Act of 1933 (15 U.S.C. 77a), as amended (the “Securities Act”), and (1) is issued by a trust that (a) is a commodity pool as defined in the Commodity Exchange Act (7 U.S.C. 1), and that is managed by a commodity pool operator registered with the Commodity Futures Trading Commission, and (b) holds long and/or short positions in exchange-traded futures contracts and/or certain currency forward contracts and/or swaps selected by the trust's advisor consistent with the trust's investment objectives, which will only include, exchange-traded futures contracts involving commodities, commodity indices, currencies, currency indices, stock indices, fixed income indices, interest rates and sovereign, private and mortgage or asset backed debt instruments, and/or forward contracts on specified currencies, and/or swaps on stock indices, fixed income indices, commodity indices, commodities, currencies, currency indices, or interest rates, each as disclosed in the trust's prospectus as such may be amended from time to time, and cash and cash equivalents; and (2) is issued and redeemed continuously in specified aggregate amounts at the next applicable NAV. See NYSE Arca Rule 8.700-E (c)(1).

    A. Proposed Amendments to NYSE Arca Rule 8.700-E

    The Exchange proposes to amend NYSE Arca Rule 8.700-E (c)(1) to add the VSTOXX as a reference asset to the futures contracts and swaps that may be held by trusts that issue Managed Trust Securities.

    The VSTOXX is a non-investable index that seeks to measure the volatility of the Index over a future time horizon as implied by the price of option contracts on the Index.9 It is based on real-time prices of options on the Index listed on the Eurex Exchange (“Eurex”),10 and is designed to reflect the market expectations of near-term up to long-term volatility by measuring the square root of the implied variances across all options of a given time to expiration. The Index includes 50 stocks that are among the largest free-float market capitalization stocks from 11 Eurozone countries.11 STOXX Limited (“STOXX”) computes the Index on a real-time basis throughout each trading day, from 3:50 a.m. until 12:30 p.m. Eastern Time. The Index value is widely disseminated by major market data vendors on a real-time basis throughout each trading day.

    9 The VSTOXX does not measure the actual volatility of the Index.

    10 Eurex is a member of the Intermarket Surveillance Group (“ISG”) and, as such, the Exchange may obtain information regarding trading in the futures contracts on VSTOXX listed by Eurex.

    11 The countries are: Austria, Belgium, Finland, France, Germany, Ireland, Italy, Luxembourg, the Netherlands, Portugal and Spain.

    Futures Contracts are cash settled and trade exclusively on Eurex between the hours of 2:30 a.m. and 5:30 p.m. Eastern Time.12 The value of these futures contracts is 100 Euros per index point of the underlying, and it is traded to two decimal places with a minimum price change of 0.05 points (equivalent to a value of 5 Euros). The daily settlement price of these futures contracts is determined during the closing auctions. The last trading day and final settlement day is 30 calendar days prior to the third Friday of the expiration month of the underlying options, which is usually the Wednesday prior to the second to last Friday of the respective maturity month. Information regarding the VSTOXX and the overlying futures can be found on STOXX's Web site and the Eurex Web site, respectively.

    12See Amendment No. 3, supra note 7, at 7, n.10, and 5.

    B. The Listing and Trading of the Shares

    The Exchange proposes to list and trade the Shares under proposed NYSE Arca Rule 8.700-E. The Fund will be a commodity pool that is a series of the ProShares Trust II (“Trust”).13 The Fund's sponsor, ProShare Capital Management LLC (“Sponsor”), is registered as a commodity pool operator and is affiliated with a Financial Industry Regulatory Authority (“FINRA”)-registered broker-dealer. Brown Brothers Harriman & Co. will be the administrator, custodian and transfer agent of the Fund and the Shares. SEI Investments Distribution Co. (“SEI”) will be the distributor for the Shares. The Fund's primary investment objective will be to provide long exposure to lead-month Futures Contracts, and the Fund will use the Futures Contracts as a performance benchmark (“Benchmark”). The Fund will be actively managed and will have a secondary investment objective to outperform the Benchmark by actively managing the “rolling” of its Futures Contracts.14

    13 On May 12, 2017, the Trust filed with the Commission a registration statement on Form S-1 under the Securities Act relating to the Fund (File No. 333-217962) (“Registration Statement”). The description of the operation of the Trust and the Fund herein is based, in part, on the Registration Statement.

    14 The Fund will not seek to track or outperform either the VSTOXX or the Index, and the performance of the Fund will be very different from the performance of either the VSTOXX Index or the Index.

    Under normal market conditions,15 the Fund generally will seek to remain fully invested at all times in lead-month Futures Contracts in a manner consistent with its investment objectives without regard to market conditions, trends, or direction.16 The Fund will invest the remainder of its un-invested assets in high-quality, short-term debt instruments that have terms-to-maturity of less than 397 days, such as U.S. government securities and repurchase agreements (“Money Market Instruments”).

    15 “Normal market conditions” is defined in NYSE Arca Rule 8.600-E (c)(5).

    16See Amendment No. 3, supra note 7, at 8.

    Under limited circumstances, the Fund also may invest in swap contracts (“Swap Contracts”) that reference the Benchmark. In the event position price or accountability limits are reached with respect to lead month Futures Contracts, the Sponsor may, in its commercially reasonable judgment, cause the Fund to invest in Swap Contracts.17 The Fund may also invest in Swap Contracts if the market for a specific Futures Contract experiences an emergency (e.g., natural disaster, terrorist attack or an act of God) or disruption (e.g., a trading halt or a flash crash) which, in the Sponsor's commercially reasonable judgment, prevent, or otherwise make it impractical, for the Fund to obtain the appropriate amount of investment exposure to the affected Futures Contracts.

    17See id. The Fund intends to enter into Swap Contracts only with major, global financial institutions; however, there are no limitations on the percentage of its assets the Fund may invest in Swap Contracts with a particular counterparty. The Fund may use various techniques to minimize credit risk. The Fund will seek to mitigate risks in connection with the uncleared OTC swaps by generally requiring that the counterparties for the Fund agree to post collateral for the benefit of the Fund, marked to market daily, subject to certain minimum thresholds.

    The Fund will also hold cash or cash equivalents, such as U.S. Treasury securities or other high credit quality, short-term fixed-income or similar securities (such as shares of money market funds and collateralized repurchase agreements), for direct investment, as collateral for its futures and Swap Contracts, or pending investment in Futures Contracts and Swap Contracts. The Fund may invest up to 100% of its assets in any of these types of cash or cash equivalent securities.

    III. Discussion and Commission's Findings

    After careful review, the Commission finds that the proposed rule change is consistent with the requirements of Section 6 of the Act 18 and the rules and regulations thereunder applicable to a national securities exchange.19 In particular, the Commission finds that the proposal is consistent with Section 6(b)(5) of the Act,20 which requires, among other things, that the Exchange's rules be designed to prevent fraudulent and manipulative acts and practices, to promote just and equitable principles of trade, to foster cooperation and coordination with persons engaged in regulating, clearing, settling, processing information with respect to, and facilitating transactions in securities, to remove impediments to and perfect the mechanism of a free and open market and a national market system, and, in general, to protect investors and the public interest. The Commission also finds that the proposal is consistent with Section 11A(a)(1)(C)(iii) of the Act,21 which sets forth Congress' finding that it is in the public interest and appropriate for the protection of investors and the maintenance of fair and orderly markets to assure the availability to brokers, dealers, and investors of information with respect to quotations for, and transactions in, securities.

    18 15 U.S.C. 78f.

    19 In approving this proposed rule change, the Commission has considered the proposed rule's impact on efficiency, competition, and capital formation. See 15 U.S.C. 78c(f).

    20 17 U.S.C. 78f(b)(5).

    21 15 U.S.C. 78k-1(a)(1)(C)(iii).

    A. Exchange's Proposal To Amend Rule 8.700-E 22

    22See Securities Exchange Act Release No. 79975 (February 6, 2017), 82 FR 10418 (February 10, 2017) (SR-NYSEArca-2017-08) (adding EURO STOXX 50 Volatility Futures to the definition of Futures Reference Asset in Rule 5.2(j)(6)); Securities Exchange Act Release No. 79069 (October 7, 2016), 81 FR 70714 (October 13, 2016) (SR-BatsBZX-2016-26) (amending Bats BZX Exchange Rule 14.11(d) to add EURO STOXX 50 Volatility Futures to the definition of Futures Reference Asset).

    With respect to the proposal to amend NYSE Arca Rule 8.700-E (c)(1) to add the VSTOXX as a reference asset to the futures contracts and swaps that may be held by trusts that issue Managed Trust Securities, the Commission notes that VSTOXX is included as a reference asset for Futures-Linked Securities,23 and notwithstanding the addition of VSTOXX as a reference asset, the existing initial and continued listing criteria applicable to Managed Trust Securities would continue to apply. These continued listing standards require, among other things, that: (1) The Disclosed Portfolio (as defined in NYSE Arca Rule 8.700-E (c)(2)) be disseminated at least daily and to all market participants at the same time; (2) an Intraday Indicative Value be calculated and widely disseminated by one or more major market data vendors on at least a 15-second basis during the Exchange's Core Trading Session; and (3) following the initial 12-month period after the commencement of trading of an issue of Managed Trust Securities, (a) the trust must have 50,000 or more Managed Trust Securities issued and outstanding, (b) the market value of all Managed Trust Securities issued and outstanding must be $1,000,000 or more, and (c) there must be 50 or more record and/or beneficial holders.24

    23See NYSE Arca Rule 5.2-E (j)(6)(v).

    24See NYSE Arca Rule 8.700-E(e)(2).

    Additionally, the Commission notes that the Exchange has represented that its surveillance procedures are adequate to continue to properly monitor the trading of the Managed Trust Securities that hold Futures Contracts and/or swaps on VSTOXX in all trading sessions and to deter and detect violations of Exchange rules.25

    25See Amendment No. 3, supra note 7, at 6.

    B. Exchange's Proposal To List and Trade the ProShares European Volatility Futures ETF

    The Commission notes the Exchange deems the Shares to be equity securities, thus rendering trading in the Shares subject to the Exchange's existing rules governing the trading of equity securities. Quotation and last-sale information for the Shares will be available via the Consolidated Tape Association (“CTA”) high-speed line, and the previous day's closing price and trading volume information for the Shares will be published daily in t