Federal Register Vol. 83, No.13,

Federal Register Volume 83, Issue 13 (January 19, 2018)

Page Range2733-2884
FR Document

83_FR_13
Current View
Page and SubjectPDF
83 FR 2883 - Martin Luther King, Jr., Federal Holiday, 2018PDF
83 FR 2767 - Sunshine Act MeetingPDF
83 FR 2747 - Proposed Amendment of Class B Airspace; San Francisco, CAPDF
83 FR 2823 - Sunshine Act: OPIC Annual Public HearingPDF
83 FR 2875 - Notice of OFAC Sanctions ActionsPDF
83 FR 2774 - Proposed Information Collection Request; Comment Request; Cross-Media Electronic Reporting Rule (Renewal)PDF
83 FR 2775 - Proposed Information Collection Request; Comment Request; Recordkeeping and Reporting of the Production, Import, Export, Destruction, Transhipment, and Exempted Uses of Ozone-Depleting Substances (Renewal)PDF
83 FR 2738 - Drawbridge Operation Regulation; Atlantic Intracoastal Waterway, Ormond Beach, FLPDF
83 FR 2738 - Minimum Technical Standards for Class II Gaming Systems and Equipment; CorrectionPDF
83 FR 2772 - Procurement List; DeletionsPDF
83 FR 2780 - Submission for OMB Review; Certification of Independent Price Determination, Contractor Code of Business Ethics and Compliance, and Preventing Personal Conflicts of InterestPDF
83 FR 2822 - Advisory Committee on Reactor Safeguards; Notice of MeetingPDF
83 FR 2781 - Submission for OMB Review; Organization and Direction of WorkPDF
83 FR 2777 - Environmental Impact Statements; Notice of AvailabilityPDF
83 FR 2865 - Soo Line Railroad Company-Trackage Rights Exemption-BNSF Railway CompanyPDF
83 FR 2782 - Proposed Data Collection Submitted for Public Comment and RecommendationsPDF
83 FR 2770 - Certain Circular Welded Carbon Steel Pipes and Tubes From Taiwan: Amended Final Results of Antidumping Duty Administrative Review; 2015-2016PDF
83 FR 2768 - Cast Iron Soil Pipe Fittings From China: Amended Preliminary Determination of Countervailing Duty InvestigationPDF
83 FR 2769 - Certain Pasta From Italy: Notice of Partial Rescission of Antidumping Duty Administrative ReviewPDF
83 FR 2768 - Common Alloy Aluminum Sheet From the People's Republic of China: Postponement of Preliminary Determination in the Countervailing Duty InvestigationPDF
83 FR 2773 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Teacher Education Assistance for College and Higher Education Grant Eligibility RegulationsPDF
83 FR 2758 - Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C; Draft Guidance for Industry and Food and Drug Administration Staff; AvailabilityPDF
83 FR 2792 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic ActPDF
83 FR 2787 - Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application; Guidance for Industry; AvailabilityPDF
83 FR 2790 - Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; AvailabilityPDF
83 FR 2786 - Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; AvailabilityPDF
83 FR 2862 - Data Collection Available for Public CommentsPDF
83 FR 2863 - Notice of Determinations; Additional Culturally Significant Objects Imported for Exhibition Determinations: “Eyewitness Views: Making History in 18th-Century Europe” ExhibitionPDF
83 FR 2864 - Notice of Determinations; Culturally Significant Objects Imported for Exhibition Determinations: “The Paston Treasure: Microcosm of the Known World” ExhibitionPDF
83 FR 2863 - Notice of Determinations; Culturally Significant Objects Imported for Exhibition Determinations: “Klimt and Schiele: Drawn” ExhibitionPDF
83 FR 2864 - Notice of Determinations; Culturally Significant Objects Imported for Exhibition Determinations: “Being: New Photography 2018” ExhibitionPDF
83 FR 2864 - Notice of Determinations; Culturally Significant Objects Imported for Exhibition Determinations: “Degas: A Passion for Perfection” ExhibitionPDF
83 FR 2864 - Notice of Determinations: Culturally Significant Objects Imported for Exhibition Determinations: “Like Life: Sculpture, Color, and the Body” ExhibitionPDF
83 FR 2819 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Extension With Change, of a Previously Approved Collection Customer Satisfaction Assessment SurveyPDF
83 FR 2771 - Procurement List; Proposed Addition and DeletionsPDF
83 FR 2794 - Gastrointestinal Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for CommentsPDF
83 FR 2797 - Material Threat Medical Countermeasure Priority Review Vouchers; Draft Guidance for Industry; AvailabilityPDF
83 FR 2796 - Product Title and Initial U.S. Approval in Highlights for Human Prescription Drug and Biological Products-Content and Format; Draft Guidance for Industry; AvailabilityPDF
83 FR 2789 - Laser Products-Conformance With IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (Laser Notice No. 56); Draft Guidance for Industry and Food and Drug Administration Staff; AvailabilityPDF
83 FR 2743 - Secretarial Determination To Lower Head Start Center-Based Service Duration RequirementPDF
83 FR 2813 - Agency Information Collection Activities: Drawback Process RegulationsPDF
83 FR 2747 - Withdrawal of Certain Proposed Rules and Other Proposed Actions; CorrectionPDF
83 FR 2779 - Agency Information Collection Activities: Comment RequestPDF
83 FR 2778 - Agency Information Collection Activities: Comment RequestPDF
83 FR 2777 - Agency Information Collection Activities: Comment RequestPDF
83 FR 2813 - Random Drug Testing Rate for Covered Crewmembers for 2018PDF
83 FR 2818 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Investigator Integrity Questionnaire-ATF F 8620.7PDF
83 FR 2738 - Department of State 2018 Civil Monetary Penalties Inflationary Adjustment; CorrectionPDF
83 FR 2767 - Submission for OMB Review; Comment RequestPDF
83 FR 2873 - Hours of Service of Drivers of Commercial Motor Vehicles: Proposed Regulatory Guidance Concerning the Use of a Commercial Motor Vehicle for Personal Conveyance; Extension of Comment PeriodPDF
83 FR 2809 - Center for Scientific Review; Notice of Closed MeetingsPDF
83 FR 2876 - Agency Information Collection Activity: Pulmonary Health and Deployment to Southwest Asia and AfghanistanPDF
83 FR 2811 - National Institute on Deafness and Other Communication Disorders; Notice of Closed MeetingsPDF
83 FR 2808 - National Institute on Deafness and Other Communication Disorders; Notice of Closed MeetingsPDF
83 FR 2806 - National Cancer Institute Amended Notice of MeetingPDF
83 FR 2810 - National Institute of General Medical Sciences; Notice of Closed MeetingsPDF
83 FR 2805 - Center for Scientific Review; Notice of Closed MeetingsPDF
83 FR 2810 - National Institute of General Medical Sciences; Notice of Closed MeetingPDF
83 FR 2811 - Eunice Kennedy Shriver National Institute of Child Health and Human Development; Amended Notice of MeetingPDF
83 FR 2807 - National Institute of Allergy and Infectious Diseases; Notice of Closed MeetingPDF
83 FR 2810 - National Institute of Allergy and Infectious Diseases; Notice of Closed MeetingsPDF
83 FR 2812 - National Institute of Allergy and Infectious Diseases; Notice of Closed MeetingsPDF
83 FR 2805 - National Institute on Alcohol Abuse and Alcoholism; Amended Notice of MeetingPDF
83 FR 2811 - National Human Genome Research Institute; Notice of MeetingsPDF
83 FR 2807 - National Cancer Institute; Notice of MeetingPDF
83 FR 2808 - Center for Scientific Review; Notice of Closed MeetingsPDF
83 FR 2804 - Center for Scientific Review; Notice of Closed MeetingsPDF
83 FR 2807 - Center for Scientific Review; Notice of Closed MeetingsPDF
83 FR 2825 - Self-Regulatory Organizations; The Options Clearing Corporation; Order Approving Proposed Rule Change, as Modified by Amendment No. 1, Concerning The Options Clearing Corporation's Adoption of a New Minimum Cash Requirement for the Clearing FundPDF
83 FR 2843 - Self-Regulatory Organizations; The Options Clearing Corporation; Notice of No Objection to Advance Notice, as Modified by Amendment No. 1, Concerning the Adoption of a New Minimum Cash Requirement for the Clearing FundPDF
83 FR 2834 - Self-Regulatory Organizations; Nasdaq PHLX LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Adopt Pricing for NDXPPDF
83 FR 2823 - Self-Regulatory Organizations; NYSE American LLC; Order Approving a Proposed Rule Change To Amend Rule 971.1NY To Amend the Duration of a Customer Best Execution AuctionPDF
83 FR 2847 - Self-Regulatory Organizations; ICE Clear Europe Limited; Notice of Proposed Rule Change, Security-Based Swap Submission or Advance Notice Relating to the ICE Clear Europe Wind Down Framework and Plan (the “Wind-Down Plan” or the “Plan”), as Most Recently AmendedPDF
83 FR 2855 - Self-Regulatory Organizations; ICE Clear Europe Limited; Notice of Proposed Rule Change, Security-Based Swap Submission or Advance Notice Relating to the ICE Clear Europe Recovery PlanPDF
83 FR 2839 - Self-Regulatory Organizations; Nasdaq PHLX LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend the Exchange's Fee Schedule at Chapter IXPDF
83 FR 2828 - Self-Regulatory Organizations; National Securities Clearing Corporation; Notice of Filing of a Proposed Rule Change To Enhance the Calculation of the Volatility Component of the Clearing Fund Formula That Utilizes a Parametric Value-at-Risk Model and Eliminate the Market Maker Domination ChargePDF
83 FR 2859 - Self-Regulatory Organizations; The Nasdaq Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend Transaction Credits at Rule 7018(a)PDF
83 FR 2850 - Self-Regulatory Organizations; NYSE Arca, Inc.; Order Granting Approval of a Proposed Rule Change, as Modified by Amendment No. 6, To List and Trade Shares of the JPMorgan Long/Short ETF Under NYSE Arca Rule 8.600-EPDF
83 FR 2765 - Hours of Service of Drivers of Commercial Motor Vehicles; Proposed Regulatory Guidance Concerning the Transportation of Agricultural Commodities; Extension of Comment PeriodPDF
83 FR 2869 - Hours of Service of Drivers: Application for Exemption; Motion Picture Association of AmericaPDF
83 FR 2872 - Agency Information Collection Activities; Renewal of a Currently Approved Information Collection Request: Generic Clearance of Customer Satisfaction SurveysPDF
83 FR 2821 - Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service DeliveryPDF
83 FR 2868 - Hours of Service; Electronic Logging Devices; Limited 90-Day Waiver; Truck Renting and Leasing Association, Inc.PDF
83 FR 2744 - Hours of Service of Drivers; Electronic Logging Devices; Limited 90-Day Waiver for Old Dominion and Other Motor Carriers Experiencing Problems Integrating PeopleNet ELD System Updates Into Their Fleet Management SystemsPDF
83 FR 2877 - Agency Information Collection Activity Under OMB Review: Servicer's Staff Appraisal Reviewer (SAR) ApplicationPDF
83 FR 2878 - Agency Information Collection Activity: Eligibility Verification Reports (EVRs)PDF
83 FR 2878 - Agency Information Collection Activity: Application for Dependency and Indemnity Compensation, Death Pension and Accrued Benefits by a Surviving Spouse or Child; Application for Dependency and Indemnity Compensation by a Surviving Spouse or Child-In-Service Death; Application for DIC, Death Pension, and/or Accrued BenefitsPDF
83 FR 2816 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Arson and Explosives Training Registration Request for Non-ATF Employees-ATF F 6310.1PDF
83 FR 2817 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Police Check Inquiry-ATF F 8620.42PDF
83 FR 2817 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Application and Permit for Permanent Exportation of Firearms (National Firearms Act)-ATF F 9 (5320.9)PDF
83 FR 2784 - Agency Information Collection Activities: Submission for OMB Review; Comment RequestPDF
83 FR 2820 - Notice of Lodging of Proposed Consent Decree Under the Clean Air ActPDF
83 FR 2785 - Agency Information Collection Activities: Proposed Collection; Comment RequestPDF
83 FR 2815 - Agency Information Collection Activities: Revision of a Currently Approved Collection: Application for Civil Surgeon DesignationPDF
83 FR 2814 - Agency Information Collection Activities; Extension, Without Change, of a Currently Approved Collection; Request for Fee Waiver; Request for Fee ExemptionPDF
83 FR 2874 - Multiemployer Pension Plan Application To Reduce BenefitsPDF
83 FR 2866 - Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of Information Collection: Renewal, Rotorcraft External Load Operator Certificate ApplicationPDF
83 FR 2865 - Agency Information Collection Activities: Requests for Comments; Clearance of a Renewed Approval of Information Collection: Helicopter Air Ambulance Operator ReportsPDF
83 FR 2799 - Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Information Collection Request Title: National Practitioner Data Bank for Adverse Information on Physicians and Other Health Care Practitioners-OMB No. 0915-0126-RevisionPDF
83 FR 2802 - CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and TreatmentPDF
83 FR 2782 - Senior Executive Service Performance Review Board MembershipPDF
83 FR 2820 - Notice of Lodging of Proposed Consent Decree Under the Comprehensive Environmental Response, Compensation, and Liability Act; and Federal Debt Collection Procedures ActPDF
83 FR 2802 - Statement of Organization, Functions, and Delegations of AuthorityPDF
83 FR 2804 - Office for Civil Rights; Statement of DelegationPDF
83 FR 2759 - Changes To Eliminate Unnecessary RegulationsPDF
83 FR 2762 - Consent for Release of VA Medical RecordsPDF
83 FR 2739 - Determination of Rates and Terms for Public Broadcasting (PB III)PDF
83 FR 2737 - Amendment of Class E Airspace; Lebanon, MOPDF
83 FR 2867 - Notice of Final Federal Agency Actions on Proposed Highway Project in Rhode IslandPDF
83 FR 2733 - Airworthiness Directives; Dassault Aviation AirplanesPDF
83 FR 2774 - Environmental Financial Advisory Board MeetingPDF

Issue

83 13 Friday, January 19, 2018 Contents Agriculture Agriculture Department PROPOSED RULES Withdrawal of Certain Proposed Rules and Other Proposed Actions; Correction, 2747 2018-00893 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 2767 2018-00879 Alcohol Tobacco Firearms Alcohol, Tobacco, Firearms, and Explosives Bureau NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Application and Permit for Permanent Exportation of Firearms (National Firearms Act), 2817-2818 2018-00835 Arson and Explosives Training Registration Request for Non-ATF Employees, 2816-2817 2018-00837 Investigator Integrity Questionnaire, 2818-2819 2018-00882 Police Check Inquiry, 2817 2018-00836 Centers Disease Centers for Disease Control and Prevention NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 2782-2784 2018-00926 Centers Medicare Centers for Medicare & Medicaid Services NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 2784-2786 2018-00832 2018-00834 Chemical Chemical Safety and Hazard Investigation Board NOTICES Meetings; Sunshine Act, 2767-2768 2018-01066 Children Children and Families Administration RULES Secretarial Determination To Lower Head Start Center-Based Service Duration Requirement, 2743-2744 2018-00897 Coast Guard Coast Guard RULES Drawbridge Operations: Atlantic Intracoastal Waterway, Ormond Beach, FL, 2738-2739 2018-00937 NOTICES Random Drug Testing Rate for Covered Crewmembers for 2018, 2813 2018-00884 Commerce Commerce Department See

International Trade Administration

See

Patent and Trademark Office

Committee for Purchase Committee for Purchase From People Who Are Blind or Severely Disabled NOTICES Procurement List; Additions and Deletions, 2771-2773 2018-00904 2018-00935 Copyright Royalty Board Copyright Royalty Board RULES Determination of Rates and Terms for Public Broadcasting (PB III), 2739-2743 2018-00735 Defense Department Defense Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Certification of Independent Price Determination, Contractor Code of Business Ethics and Compliance, and Preventing Personal Conflicts of Interest, 2780-2781 2018-00934 Organization and Direction of Work, 2781-2782 2018-00931 Education Department Education Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Teacher Education Assistance for College and Higher Education Grant Eligibility Regulations, 2773-2774 2018-00921 Environmental Protection Environmental Protection Agency NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Cross-Media Electronic Reporting Rule, 2774-2775 2018-00939 Recordkeeping and Reporting of the Production, Import, Export, Destruction, Transhipment, and Exempted Uses of Ozone-Depleting Substances, 2775-2777 2018-00938 Environmental Impact Statements; Availability, etc.: Weekly Receipts, 2777 2018-00929 Meetings: Environmental Financial Advisory Board, 2774 2018-00616 Export Import Export-Import Bank NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 2777-2780 2018-00887 2018-00888 2018-00889 2018-00890 2018-00891 2018-00892 Federal Aviation Federal Aviation Administration RULES Airworthiness Directives: Dassault Aviation Airplanes, 2733-2737 2018-00657 Amendment of Class E Airspace: Lebanon, MO, 2737-2738 2018-00714 PROPOSED RULES Class B Airspace; Amendments: San Francisco, CA, 2747-2757 2018-01023 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Helicopter Air Ambulance Operator Reports, 2865-2866 2018-00826 Rotorcraft External Load Operator Certificate Application, 2866-2867 2018-00827 Federal Bureau Federal Bureau of Investigation NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Customer Satisfaction Assessment Survey, 2819-2820 2018-00906 Federal Highway Federal Highway Administration NOTICES Federal Agency Actions: Proposed Highway Project in Rhode Island, 2867-2868 2018-00665 Federal Motor Federal Motor Carrier Safety Administration RULES Hours of Service of Drivers: Electronic Logging Devices; Limited 90-Day Waiver for Old Dominion and Other Motor Carriers Experiencing Problems Integrating PeopleNet ELD System Updates Into Their Fleet Management Systems, 2744-2746 2018-00842 PROPOSED RULES Hours of Service of Drivers of Commercial Motor Vehicles: Transportation of Agricultural Commodities, 2765-2766 2018-00847 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Generic Clearance of Customer Satisfaction Surveys, 2872-2873 2018-00845 Hours of Service of Drivers; Exemption Applications: Motion Picture Association of America, 2869-2871 2018-00846 Hours of Service of Drivers; Exemptions Applications: Proposed Regulatory Guidance Concerning the Use of a Commercial Motor Vehicle for Personal Conveyance; Extension of Comment Period, 2873-2874 2018-00878 Hours of Service: Electronic Logging Devices; Limited 90-Day Waiver; Truck Renting and Leasing Association, Inc., 2868-2869 2018-00843 Food and Drug Food and Drug Administration PROPOSED RULES Guidance: Public Warning and Notification of Recalls, 2758-2759 2018-00918 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Guidance for Industry on Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act, 2792-2794 2018-00917 Guidance: Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Products, etc., 2790-2792 2018-00915 Compounded Drug Products That Are Essentially Copies of Approved Drug Products, 2786-2787 2018-00914 Laser Products, 2789-2790 2018-00898 Material Threat Medical Countermeasure Priority Review Vouchers, 2797-2799 2018-00900 Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application, 2787-2789 2018-00916 Product Title and Initial U.S. Approval in Highlights for Human Prescription Drug and Biological Products, 2796-2797 2018-00899 Meetings: Gastrointestinal Drugs Advisory Committee, 2794-2796 2018-00903 General Services General Services Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Certification of Independent Price Determination, Contractor Code of Business Ethics and Compliance, and Preventing Personal Conflicts of Interest, 2780-2781 2018-00934 Organization and Direction of Work, 2781-2782 2018-00931 Gulf Coast Ecosystem Restoration Council Gulf Coast Ecosystem Restoration Council NOTICES Senior Executive Service Performance Review Board Membership, 2782 2018-00823 Health and Human Health and Human Services Department See

Centers for Disease Control and Prevention

See

Centers for Medicare & Medicaid Services

See

Children and Families Administration

See

Food and Drug Administration

See

Health Resources and Services Administration

See

National Institutes of Health

NOTICES Office for Civil Rights; Statement of Delegation, 2804 2018-00816 2018-00818 Statement of Organization, Functions, and Delegations of Authority, 2802-2803 2018-00820
Health Resources Health Resources and Services Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: National Practitioner Data Bank for Adverse Information on Physicians and Other Health Care Practitioners, 2799-2802 2018-00825 Meetings: CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment, 2802 2018-00824 Homeland Homeland Security Department See

Coast Guard

See

U.S. Citizenship and Immigration Services

See

U.S. Customs and Border Protection

Interior Interior Department See

National Indian Gaming Commission

International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Cast Iron Soil Pipe Fittings From China, 2768-2769 2018-00924 Certain Circular Welded Carbon Steel Pipes and Tubes From Taiwan, 2770-2771 2018-00925 Certain Pasta From Italy, 2769-2770 2018-00923 Common Alloy Aluminum Sheet From the People's Republic of China, 2768 2018-00922 Justice Department Justice Department See

Alcohol, Tobacco, Firearms, and Explosives Bureau

See

Federal Bureau of Investigation

NOTICES Proposed Consent Decrees: CERCLA; Federal Debt Collection Procedures Act, 2820 2018-00822 Clean Air Act, 2820-2821 2018-00833
Library Library of Congress See

Copyright Royalty Board

Merit Merit Systems Protection Board NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery, 2821-2822 2018-00844 NASA National Aeronautics and Space Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Certification of Independent Price Determination, Contractor Code of Business Ethics and Compliance, and Preventing Personal Conflicts of Interest, 2780-2781 2018-00934 Organization and Direction of Work, 2781-2782 2018-00931 National Indian National Indian Gaming Commission RULES Minimum Technical Standards for Class II Gaming Systems and Equipment; Correction, 2738 2018-00936 National Institute National Institutes of Health NOTICES Meetings: Center for Scientific Review, 2804-2810 2018-00859 2018-00860 2018-00861 2018-00870 2018-00876 Eunice Kennedy Shriver National Institute of Child Health and Human Development, 2811 2018-00868 National Cancer Institute, 2806-2807 2018-00862 2018-00872 National Human Genome Research Institute, 2811-2812 2018-00863 National Institute of Allergy and Infectious Diseases, 2807, 2810-2812 2018-00865 2018-00866 2018-00867 National Institute of General Medical Sciences, 2810 2018-00869 2018-00871 National Institute on Alcohol Abuse and Alcoholism, 2805 2018-00864 National Institute on Deafness and Other Communication Disorders, 2808-2809, 2811 2018-00873 2018-00874 Nuclear Regulatory Nuclear Regulatory Commission NOTICES Meetings: Advisory Committee on Reactor Safeguards, 2822-2823 2018-00933 Overseas Overseas Private Investment Corporation NOTICES Meetings; Sunshine Act, 2823 2018-01006 Patent Patent and Trademark Office PROPOSED RULES Changes To Eliminate Unnecessary Regulations, 2759-2762 2018-00769 Presidential Documents Presidential Documents PROCLAMATIONS Special Observances: Martin Luther King, Jr., Federal Holiday (Proc. 9689), 2881-2884 2018-01130 Securities Securities and Exchange Commission NOTICES Self-Regulatory Organizations; Proposed Rule Changes: ICE Clear Europe Limited, 2847-2850, 2855-2858 2018-00853 2018-00854 Nasdaq PHLX LLC, 2834-2843 2018-00852 2018-00856 National Securities Clearing Corp., 2828-2834 2018-00851 NYSE American LLC, 2823-2825 2018-00855 NYSE Arca, Inc., 2850-2855 2018-00849 The Nasdaq Stock Market LLC, 2859-2862 2018-00850 The Options Clearing Corp., 2825-2827, 2843-2846 2018-00858 2018-00857 Small Business Small Business Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 2862-2863 2018-00913 State Department State Department RULES Civil Monetary Penalties Inflationary Adjustment; Correction, 2738 2018-00881 NOTICES Culturally Significant Objects Imported for Exhibition: Being: New Photography 2018 Exhibition, 2864 2018-00909 Degas: A Passion for Perfection Exhibition, 2864 2018-00908 Eyewitness Views Making History in 18th-Century Europe Exhibition, 2863 2018-00912 Klimt and Schiele: Drawn Exhibition, 2863 2018-00910 Like Life: Sculpture, Color, and the Body Exhibition, 2864 2018-00907 The Paston Treasure: Microcosm of the Known World Exhibition, 2864-2865 2018-00911 Surface Transportation Surface Transportation Board NOTICES Trackage Rights Exemptions: Soo Line Railroad Co.; BNSF Railway Co., 2865 2018-00927 Transportation Department Transportation Department See

Federal Aviation Administration

See

Federal Highway Administration

See

Federal Motor Carrier Safety Administration

Treasury Treasury Department NOTICES Blocking or Unblocking of Persons and Properties, 2875-2876 2018-00940 Multiemployer Pension Plan Application to Reduce Benefits, 2874-2875 2018-00828 U.S. Citizenship U.S. Citizenship and Immigration Services NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Application for Civil Surgeon Designation, 2815-2816 2018-00831 Request for Fee Exemption, 2814-2815 2018-00830 Customs U.S. Customs and Border Protection NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Drawback Process Regulations, 2813-2814 2018-00895 Veteran Affairs Veterans Affairs Department PROPOSED RULES Consent for Release of Medical Records, 2762-2765 2018-00758 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Application for Dependency and Indemnity Compensation, Death Pension and Accrued Benefits by a Surviving Spouse or Child; Application for Dependency and Indemnity Compensation by a Surviving Spouse or Child—In-Service Death; etc., 2878-2879 2018-00839 Eligibility Verification Reports, 2878 2018-00840 Pulmonary Health and Deployment to Southwest Asia and Afghanistan, 2876-2877 2018-00875 Servicer's Staff Appraisal Reviewer Application, 2877-2878 2018-00841 Separate Parts In This Issue Part II Presidential Documents, 2881-2884 2018-01130 Reader Aids

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

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

83 13 Friday, January 19, 2018 Rules and Regulations DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2017-1250; Product Identifier 2017-NM-174-AD; Amendment 39-19159; AD 2018-02-06] RIN 2120-AA64 Airworthiness Directives; Dassault Aviation Airplanes AGENCY:

Federal Aviation Administration (FAA), DOT.

ACTION:

Final rule; request for comments.

SUMMARY:

We are adopting a new airworthiness directive (AD) for certain Dassault Aviation Model FALCON 7X, FALCON 2000EX, and FALCON 900EX airplanes. This AD requires revising the airplane flight manual (AFM) and minimum equipment list (MEL) to incorporate new limitations. This AD also provides an optional terminating action that removes the AFM and MEL limitations. This AD was prompted by a report indicating that, during approach, an airplane had an unexpected change of barometric settings on both the pilot and co-pilot sides, which also impacted certain display and navigational systems. We are issuing this AD to address the unsafe condition on these products.

DATES:

This AD becomes effective February 5, 2018.

The Director of the Federal Register approved the incorporation by reference of certain publications listed in this AD as of February 5, 2018.

We must receive comments on this AD by March 5, 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: U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

For service information identified in this final rule, contact Dassault Falcon Jet Corporation, Teterboro Airport, P.O. Box 2000, South Hackensack, NJ 07606; telephone 201-440-6700; internet http://www.dassaultfalcon.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-2017-1250.

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-2017-1250; or in person at the Docket Operations office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this AD, the 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:

Tom Rodriguez, Aerospace Engineer, International Section, Transport Standards Branch, FAA, 1601 Lind Avenue SW, Renton, WA 98057-3356; telephone 425-227-1137; fax 425-227-1149.

SUPPLEMENTARY INFORMATION:

Discussion

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive 2017-0240, dated December 5, 2017 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Dassault Aviation Model FALCON 7X, FALCON 2000EX, and FALCON 900EX airplanes. The MCAI states:

An occurrence was reported where, during approach, a Dassault 7X aeroplane experienced an unexpected change of barometric setting values, on both pilot and co-pilot sides, also having some other effects on display and navigation systems. Investigation showed that a temporary defect of a Cursor Control Device (CCD) can release erroneous but apparently valid data to the avionics. Depending on the resulting flight deck effects, crew members may be unaware of any incorrect barometric setting values.

This condition, if not corrected, could lead to a wrong flight altitude, possibly affecting continued safe flight and landing.

To address this potential unsafe condition [Dassault Aviation] DA is developing corrective actions through an upgrade of “EASy” Avionics software. Pending the availability in service of these upgrades, DA issued an Aircraft Flight Manual (AFM) amendment and a Master Minimum Equipment List (MMEL) amendment, related to dispatch with a Traffic Collision Avoidance System (TCAS) or Enhanced Ground Proximity Warning System (EGPWS).

For the reasons described above, this [EASA] AD requires amendment of the applicable AFM and MMEL [and includes an optional terminating action].

This [EASA] AD is considered an interim measure and further AD action may follow.

Although the MCAI requires updating the MMEL, this AD requires revising the MEL. The MMEL is a master list of the minimum equipment with which the airplane can operate under given circumstances. A MEL is derived from the MMEL and is tailored for individual operators. The optional terminating action is updating the aircraft avionics software to the latest EASy II version. You may examine the MCAI on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-1250.

Related Service Information Under 1 CFR Part 51

Dassault Aviation has issued the following service information.

The following service information describes procedures for updating the aircraft avionics software to the latest EASy II version. These documents are distinct since they apply to different airplane models in different configurations.

• Dassault Service Bulletin F7X-322, dated October 24, 2017.

• Dassault Service Bulletin F900EX-422, dated September 22, 2017.

• Dassault Service Bulletin F900EX-423, dated December 9, 2016.

• Dassault Service Bulletin F2000EX-322, Revision 1, dated June 21, 2017.

• Dassault Service Bulletin F2000EX-323, dated July 13, 2017.

The following service information describes MMEL dispatch restrictions for TCAS and EGPWS. These documents are distinct since they apply to different airplane models.

• Dassault Falcon 7X/8X, MMEL-CP0205-PUB-F7X, “TCAS & EGPWS limitations without CCD correction,” Revision 1, dated September 1, 2016, to the Dispatch Assistance CD-ROM Pub. 781.

• Dassault Falcon 900EX EASy, MMEL-CP0205-PUB-F900EX EASy, “TCAS & EGPWS limitations without CCD correction,” Revision 1, dated September 1, 2016, to the Dispatch Assistance CD-ROM Pub. 617.

• Dassault Falcon 2000EX EASy, MMEL-CP0205-PUB-F2000EX EASy, “TCAS & EGWPS limitation without CCD correction,” Revision 1, dated September 1, 2016, to the Dispatch Assistance CD-ROM Pub. 682.

This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

FAA's Determination and Requirements of This AD

This product has been approved by the aviation authority of 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 issuing this AD because we evaluated all pertinent information and determined the unsafe condition exists and is likely to exist or develop on other products of these same type designs.

FAA's Determination of the Effective Date

An unsafe condition exists that requires the immediate adoption of this AD. The FAA has found that the risk to the flying public justifies waiving notice and comment prior to adoption of this rule because unexpected changes to barometric settings could lead to an incorrect flight altitude and ultimately adversely affect the airplane's continued safe flight and landing. Therefore, we determined that notice and opportunity for public comment before issuing this AD are impracticable and that good cause exists for making this amendment effective in fewer than 30 days.

Comments Invited

This AD is a final rule that involves requirements affecting flight safety, and we did not precede it by notice and opportunity for public comment. We invite you to send any written relevant data, views, or arguments about this AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2017-1250; Product Identifier 2017-NM-174-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this AD. We will consider all comments received by the closing date and may amend this AD 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 AD.

Costs of Compliance

We estimate that this AD affects 320 airplanes of U.S. registry. We estimate the following costs to comply with this AD:

Estimated Costs Action Labor cost Parts cost Cost per
  • product
  • Cost on U.S.
  • operators
  • Updating the AFM/MEL 2 work-hours × $85 per hour = $170 $0 $170 $54,400
    Estimated Costs for Optional Actions Action Labor cost Parts cost Cost per
  • product
  • Software update 8 work-hours × $85 per hour = $680 $0 $680

    According to the manufacturer, some of the costs of this 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 available 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 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 AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

    For the reasons discussed above, I certify that this AD:

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

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

    3. Will not affect intrastate aviation in Alaska; and

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

    List of Subjects in 14 CFR Part 39

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

    Adoption of the Amendment

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

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

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

    § 39.13 [Amended]
    2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD): 2018-02-06 Dassault Aviation: Amendment 39-19159; Docket No. FAA-2017-1250; Product Identifier 2017-NM-174-AD. (a) Effective Date

    This AD becomes effective February 5, 2018.

    (b) Affected ADs

    None.

    (c) Applicability

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

    (1) Model FALCON 7X airplanes, all serial numbers, except those that have embodied Dassault modification M1254 or M1705 in production, or Dassault Service Bulletin F7X-322 in service.

    (2) Model FALCON 2000EX airplanes, all serial numbers that have embodied Dassault modification M1691 in production, except those that have embodied Dassault modification M3849 in production, or Dassault Service Bulletin F2000EX-322 or Dassault Service Bulletin F2000EX-323 in service.

    (3) Model FALCON 900EX airplanes, all serial numbers that have embodied Dassault modification M3083 in production, except those that have embodied Dassault modification M6002 in production, or Dassault Service Bulletin F900EX-422 or Dassault Service Bulletin F900EX-423 in service.

    (d) Subject

    Air Transport Association (ATA) of America Code 34, Navigation.

    (e) Reason

    This AD was prompted by a report indicating that, during approach, an airplane had an unexpected change of barometric settings on both the pilot and co-pilot sides, which also impacted certain display and navigational systems. We are issuing this AD to address unexpected changes to barometric settings, which could lead to an incorrect flight altitude and could ultimately adversely affect the airplane's continued safe flight and landing.

    (f) Compliance

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

    (g) Airplane Flight Manual (AFM) Revision

    Within 10 flight cycles after the effective date of this AD, revise the Limitations Section of the Airplane Flight Manual (AFM) to include the statement specified in figure 1 to paragraph (g) of this AD. When a statement identical to that in figure 1 to paragraph (g) of this AD has been included in the limitations section of the general revisions of the AFM, the general revisions may be inserted into the AFM.

    ER19JA18.000 (h) Minimum Equipment List (MEL) Revision

    Within 10 flight cycles after the effective date of this AD, revise the operator's MEL by incorporating the applicable information specified in figure 2 to paragraph (h) of this AD as a temporary restriction when dispatching the airplane with an inoperative traffic alert and collision avoidance system (TCAS) or enhanced ground proximity warning system (EGPWS). The MEL can be revised by inserting a copy of the applicable MMEL-CP page specified in figure 2 to paragraph (h) of this AD into the MEL. After revising the applicable MEL, dispatch of that airplane with an inoperative TCAS or EGWPS is allowed, provided that the applicable MEL for that airplane has been revised, as specified in the applicable dispatch restrictions specified in figure 2 to paragraph (h) of this AD.

    ER19JA18.001 (i) Optional Terminating Action

    Modification of an airplane by updating the aircraft avionics software to the latest EASy II version in accordance with the applicable service information specified in figure 3 to paragraph (i) of this AD terminates the requirements of paragraphs (g) and (h) of this AD for the modified airplane only.

    ER19JA18.002 (j) Credit for Previous Actions

    This paragraph provides credit for the actions specified in paragraph (i) of this AD, if those actions were performed before the effective date of this AD using Dassault Service Bulletin F2000EX-322, dated October 17, 2016, for the airplanes identified therein.

    (k) Other FAA AD Provisions

    The following provisions also apply to this AD:

    (1) Alternative Methods of Compliance (AMOCs): The Manager, International Section, Transport Standards 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 International Section, send it to the attention of the person identified in paragraph (l)(2) of this AD. Information may be emailed to: [email protected] 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, International Section, Transport Standards Branch, FAA; or the European Aviation Safety Agency (EASA); or Dassault Aviation's EASA Design Organization Approval (DOA). If approved by the DOA, the approval must include the DOA-authorized signature.

    (l) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA Airworthiness Directive 2017-0240, dated December 5, 2017, for related information. You may examine the MCAI on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-1250.

    (2) For more information about this AD, contact Tom Rodriguez, Aerospace Engineer, International Section, Transport Standards Branch, FAA, 1601 Lind Avenue SW, Renton, WA 98057-3356; telephone 425-227-1137; fax 425-227-1149.

    (3) Service information identified in this AD that is not incorporated by reference is available at the addresses specified in paragraphs (m)(3) and (m)(4) of this AD.

    (m) Material Incorporated by Reference

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

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

    (i) Dassault Falcon 7X/8X, MMEL-CP0205-PUB-F7X, “TCAS & EGPWS limitations without CCD correction,” Revision 1, dated September 1, 2016, to the Dispatch Assistance CD-ROM Pub. 781.

    (ii) Dassault Falcon 2000EX EASy, MMEL-CP0205-PUB-F2000EX EASy, “TCAS & EGWPS limitation without CCD correction,” Revision 1, dated September 1, 2016, to the Dispatch Assistance CD-ROM Pub. 682.

    (iii) Dassault Falcon 900EX EASy, MMEL-CP0205-PUB-F900EX EASy, “TCAS & EGPWS limitations without CCD correction,” Revision 1, dated September 1, 2016, to the Dispatch Assistance CD-ROM Pub. 617.

    (iv) Dassault Service Bulletin F7X-322, dated October 24, 2017.

    (v) Dassault Service Bulletin F2000EX-322, Revision 1, dated June 21, 2017.

    (vi) Dassault Service Bulletin F2000EX-323, dated July 13, 2017.

    (vii) Dassault Service Bulletin F900EX-422, dated September 22, 2017.

    (viii) Dassault Service Bulletin F900EX-423, dated December 9, 2016.

    (3) For service information identified in this AD, contact Dassault Falcon Jet Corporation, Teterboro Airport, P.O. Box 2000, South Hackensack, NJ 07606; telephone 201-440-6700; internet http://www.dassaultfalcon.com.

    (4) 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.

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

    Issued in Renton, Washington, on January 5, 2018. Michael Kaszycki, Acting Director, System Oversight Division, Aircraft Certification Service.
    [FR Doc. 2018-00657 Filed 1-18-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-2017-0176; Airspace Docket No. 17-ACE-3] Amendment of Class E Airspace; Lebanon, MO AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Final rule.

    SUMMARY:

    This action modifies Class E airspace extending upward from 700 feet above the surface at Floyd W. Jones Airport, Lebanon, MO. This action is necessary due to the decommissioning of the Lebanon non-directional radio beacon (NDB), and cancellation of the NDB approach. This action enhances the safety and management of standard instrument approach procedures for instrument flight rules (IFR) operations at the airport.

    DATES:

    Effective 0901 UTC, March 29, 2018. The Director of the Federal Register approves this incorporation by reference action under Title 1, Code of Federal Regulations, part 51, subject to the annual revision of FAA Order 7400.11 and publication of conforming amendments.

    ADDRESSES:

    FAA Order 7400.11B, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. For further information, you can contact the Airspace Policy Group, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-8783. The Order is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of FAA Order 7400.11B at NARA, call (202) 741-6030, or go to http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.

    FOR FURTHER INFORMATION CONTACT:

    Rebecca Shelby, Federal Aviation Administration, Support Specialist, Operations Support Group, Central Service Center, 10101 Hillwood Parkway, Fort Worth, TX 76177; telephone (817) 222-5857.

    SUPPLEMENTARY INFORMATION:

    Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is found in title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it amends Class E airspace extending upward from 700 feet above the surface at Floyd W. Jones Airport, Lebanon, MO, to support standard instrument approach procedures for IFR operations at the airport.

    History

    The FAA published a notice of proposed rulemaking in the Federal Register for Docket No. FAA-2017-0176 (82 FR 18874; April 24, 2017). The NPRM proposed to modify Class E airspace at Floyd W. Jones airport, Lebanon, Mo., extending upward from 700 feet above the surface. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

    Class E airspace designations are published in paragraph 6005 of FAA Order 7400.11B, dated August 3, 2017, and effective September 15, 2017, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.

    Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order 7400.11B, Airspace Designations and Reporting Points, dated August 3, 2017, and effective September 15, 2017. FAA Order 7400.11B is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11B lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

    The Rule

    This amendment to Title 14 Code of Federal Regulations (14 CFR) part 71 modifies Class E airspace extending upward from 700 feet above the surface within a 6.5-mile radius of Floyd W. Jones Airport, Lebanon, MO.

    Airspace reconfiguration is necessary due to the decommissioning and cancellation of the Lebanon NDB, and NDB approaches. This action enhances the safety and management of the standard instrument approach procedures for IFR operations at the airport.

    Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

    Environmental Review

    The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 5-6.5.a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.

    List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

    Adoption of the Amendment

    In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:

    PART 71—DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR TRAFFIC SERVICE ROUTES; AND REPORTING POINTS 1. The authority citation for 14 CFR part 71 continues to read as follows: Authority:

    49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

    § 71.1 [Amended]
    2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11B, Airspace Designations and Reporting Points, dated August 3, 2017, and effective September 15, 2017, is amended as follows: Paragraph 6005 Class E Airspace Areas Extending Upward From 700 Feet or More Above the Surface of the Earth. ACE MO E5 Lebanon, MO [Amended] Floyd W. Jones Airport, MO (Lat. 37°38′54″ N, long. 92°39′09″ W)

    That airspace extending upward from 700 feet above the surface within a 6.5-mile radius of Floyd W. Jones Airport.

    Issued in Fort Worth, Texas on January 9, 2018. Christopher L. Southerland, Acting Manager, Operations Support Group, ATO Central Service Center.
    [FR Doc. 2018-00714 Filed 1-18-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF STATE 22 CFR Part 127 [Public Notice 10273] RIN 1400-AE50 Department of State 2018 Civil Monetary Penalties Inflationary Adjustment; Correction AGENCY:

    Department of State.

    ACTION:

    Final rule; correcting amendment.

    SUMMARY:

    The Department of State published a final rule in the Federal Register on January 3, 2018, providing revised civil monetary penalties for 2018. This document corrects one of the civil monetary penalties.

    DATES:

    This rule is effective on January 19, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Alice Kottmyer, Office of the Legal Adviser, 202-647-2318.

    SUPPLEMENTARY INFORMATION:

    Need for Correction

    In FR Doc 2017-28395, in the Federal Register of January 3, 2018 (83 FR 234), on page 237, in the first column, amendatory instruction 6b, for § 127.10(a)(1)(ii) revised the penalty to read “$808,458”, but it should have read “$824,959, or five times the amount of the prohibited incentive payment, whichever is greater”.

    Accordingly, this document corrects the civil monetary penalty listed in 22 CFR 127.10(a)(1)(ii).

    List of Subjects in 22 CFR Part 127

    Arms and munitions, Exports.

    For the reasons set forth above, 22 CFR part 127 is corrected by making the following correcting amendment:

    PART 127—VIOLATIONS AND PENALTIES 1. The authority citation for part 127 continues to read as follows: Authority:

    Sections 2, 38, and 42, Pub. L. 90-629, 90 Stat. 744 (22 U.S.C. 2752, 2778, 2791); 22 U.S.C. 401; 22 U.S.C. 2651a; 22 U.S.C. 2779a; 22 U.S.C. 2780; E.O. 13637, 78 FR 16129; Pub. L. 114-74, 129 Stat. 584.

    § 127.10 [Amended]
    2. Section 127.10(a)(1)(ii) is amended by removing “$824,959” and adding in its place “$824,959, or five times the amount of the prohibited incentive payment, whichever is greater”. Alice M. Kottmyer, Attorney-Adviser, Office of Management, Department of State.
    [FR Doc. 2018-00881 Filed 1-18-18; 8:45 am] BILLING CODE 4710-10-P
    NATIONAL INDIAN GAMING COMMISSION 25 CFR Part 547 RIN 3141-AA64 Minimum Technical Standards for Class II Gaming Systems and Equipment; Correction AGENCY:

    National Indian Gaming Commission.

    ACTION:

    Final rule; correction.

    SUMMARY:

    On December 27, 2017, the National Indian Gaming Commission published a rule amending its minimum technical standards for Class II gaming systems and equipment. This document corrects the preamble regarding the OMB Control Number and OMB Control Number expiration date.

    DATES:

    Effective January 19, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Austin Badger, National Indian Gaming Commission; 1849 C Street NW, MS 1621, Washington, DC 20240. Telephone: 202-632-7003.

    SUPPLEMENTARY INFORMATION:

    In the final rule FR Doc. 2017-27945, published on December 27, 2017, the following correction is made:

    On page 61175, in the second column, the paragraph “The information collection requirements contained in this rule were previously approved by the Office of Management and Budget (OMB) as required by 44 U.S.C. 3501 et seq. and assigned OMB Control Number 3141-0007, which expired in August of 2011. The NIGC is in the process of reinstating that Control Number.” is corrected to read “The information collection requirements contained in this rule were previously approved by the Office of Management and Budget (OMB) as required by 44 U.S.C. 3501 et seq. and assigned OMB Control Number 3141-0014. The OMB control number expires on November 30, 2018.”

    Dated: January 16, 2018. Jonodev O. Chaudhuri, Chairman. Kathryn Isom-Clause, Vice Chair. E. Sequoyah Simermeyer, Associate Commissioner.
    [FR Doc. 2018-00936 Filed 1-18-18; 8:45 am] BILLING CODE 7565-01-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 117 [Docket No. USCG-2018-0019] Drawbridge Operation Regulation; Atlantic Intracoastal Waterway, Ormond Beach, FL AGENCY:

    Coast Guard, DHS.

    ACTION:

    Notice of deviation from drawbridge regulation.

    SUMMARY:

    The Coast Guard has issued a temporary deviation from the operating schedule that governs the Highbridge Road (Knox) Bridge across the Atlantic Intracoastal Waterway (Halifax River), mile 816.0, at Ormond Beach, FL.

    The deviation is necessary to accommodate the replacement of trunnion bearings for the west bascule leaf. This deviation allows the bridge single-leaf operations, reducing the horizontal clearance to 45 feet.

    DATES:

    This deviation is effective without actual notice from January 19, 2018 through 7 p.m. on February 20, 2018. For the purposes of enforcement, actual notice will be used from 7 a.m. on January 16, 2018, until January 19, 2018.

    ADDRESSES:

    The docket for this deviation, USCG-2018-0019, is available at http://www.regulations.gov. Type the docket number in the “SEARCH” box and click “SEARCH”. Click on Open Docket Folder on the line associated with this deviation.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions on this temporary deviation, call or email MST3 Rory Boyle, Coast Guard Sector Jacksonville, Waterways Management Division, telephone 904-714-7648, email [email protected]

    SUPPLEMENTARY INFORMATION:

    The owner of the bridge, Volusia County, Florida, requested a temporary deviation. The trunnion bearings on the west bascule leaf are damaged. Replacement requires jacking the bascule leaf to remove and install new bearings.

    The Highbridge Road (Knox) Bridge across the Atlantic Intracoastal Waterway (Halifax River), mile 816.0, at Ormond Beach, Florida is a double-leaf bascule bridge with a vertical clearance of 11 feet at mean high water in the closed position and a horizontal clearance of 91 feet between fenders. The existing bridge operating schedule is published in 33 CFR 117.5.

    This temporary deviation allows the bridge single-leaf operations from 7 a.m. on January 16, 2018 through 7 p.m. on February 20, 2018. This temporary deviation will reduce the horizontal clearance to 45 feet through the east bascule span. The waterway is used by a variety of vessels including U.S. government vessels, small commercial vessels, recreational vessels and tugs and barge traffic. Due to the mechanical issues, the bridge has operated on single-leaf operations with a double-leaf opening upon request. Vessels able to pass through the bridge in the closed position may do so at any time. The bridge will not be able to provide a double-leaf opening for emergencies and there is no immediate alternate route for vessels to pass.

    The Coast Guard will also inform the users of the waterways through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge so that vessel operators can arrange their transits to minimize any impact caused by the temporary deviation.

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

    Dated: January 16, 2018. Barry L. Dragon, Director, Bridge Branch, Seventh Coast Guard District.
    [FR Doc. 2018-00937 Filed 1-18-18; 8:45 am] BILLING CODE 9110-04-P
    LIBRARY OF CONGRESS Copyright Royalty Board 37 CFR Part 381 [Docket No. 16-CRB-0002-PBR (2018-2022)] Determination of Rates and Terms for Public Broadcasting (PB III) AGENCY:

    Copyright Royalty Board (CRB), Library of Congress.

    ACTION:

    Final rule.

    SUMMARY:

    The Copyright Royalty Judges publish this final rule regarding rates and terms for use of certain works in connection with noncommercial broadcasting for the period commencing January 1, 2018, and ending on December 31, 2022.

    DATES:

    Effective date: This rule is effective on January 19, 2018.

    Applicability dates: This rule applies to the license period January 1, 2018, through December 31, 2022.

    ADDRESSES:

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

    FOR FURTHER INFORMATION CONTACT:

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

    SUPPLEMENTARY INFORMATION:

    Background

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

    Copyright owners and public broadcasting entities 1 may negotiate rates and terms under the section 118 license for categories of copyrighted works and uses that would be binding on all owners and entities using the same license 2 and submit them to the Judges for approval. 17 U.S.C. 801(b)(7)(A). The participants 3 in the proceeding settled and submitted to the Judges proposed rates for the relevant categories and uses, which the Judges published in the Federal Register for comment on November 3, 2017. 82 FR 51589.

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

    2 Copyright owners may negotiate rates and terms with specific public broadcasting entities for the use of all of the copyright owners' works covered by the Section 118 license. Section 118(b)(2) provides that such license agreements “shall be given effect in lieu of any determination by the * * * Copyright Royalty Judges,” provided that copies of the agreement are submitted to the Judges “within 30 days of execution.” 17 U.S.C. 118(b)(2). The Judges received three such agreements (from BMI, ASCAP, and SESAC).

    3 The Judges received settlement proposals from the following active participants: The American Society of Authors, Composers and Publishers (“ASCAP”); SESAC, Inc.; Broadcast Music, Inc. (“BMI”); Educational Media Foundation (“EMF”); National Public Radio (“NPR”) and the Public Broadcasting Service (“PBS”), jointly; National Religious Broadcasters Noncommercial Music License Committee (“NRBNMLC”); the National Music Publishers' Association (“NMPA”), The Harry Fox Agency (“HFA”), National Association of College and University Business Officers (“NACUBO”). The remaining active participant, Church Music Publishers Association (“CMPA”), approved the four joint proposals involving ASCAP/BMI/SESAC/HFA and NMPA and NRBNMLC/EMF.

    The Judges received two comments, a joint comment from participants ASCAP, BMI, NPR, PBS, and SESAC, and a comment from non-participant Global Music Rights, LLC (“GMR”).4

    4 The Judges correct one error in the proposed regulatory text published in the proposed rule. They remove the preface after the heading of 381.4 because that language (with proposed revisions) is now in subparagraph (a).

    The joint comment from participants proposed a revision to § 381.4(b) to conform it to §§ 381.5 and 381.6 by making explicit that the rates only apply to compositions not in the repertories of ASCAP, BMI, and SESAC.5 This change would ensure that, were a voluntary agreement to terminate within the license period, the statutory rate would not apply to compositions in the repertories of ASCAP, BMI, and SESAC. The Judges find the proposed revision is too late and they reject it for several reasons, including:

    5 In the Supplementary Information provided in the Proposed Rule relating to this license, the Judges noted that “NPR and PBS filed proposed changes . . . in § 381.4 . . . [which] conform to analogous changes in §§ 381.5 and 381.6.” 82 FR at 51591 (Nov. 7, 2017). See Submission of NPR and PBS (Oct. 25, 2017). The conforming changes were those establishing the $1.00 backstop rate. None of the participants sought the limitation language they now urge.

    1. The proposed language was not sought by any party before the proposed regulations were published for public comment.

    2. The proposed language is not in the current regulations.

    3. The proposed regulation includes a rate for licenses that are not subject to a voluntary, negotiated agreement.

    4. Extension, renewal, or renegotiation of any negotiated agreement to avoid the statutory rate is within the control of ASCAP, BMI, and SESAC.

    Notwithstanding the agreement of all parties who allegedly might be affected by this late-proposed change, making this change would alter the proposed regulation without affording interested parties an opportunity for review and comment or objection.

    The comment from GMR raised two concerns. GMR objects to a decrease in the § 381.4 rate for non-participants and requests the Judges keep the current rates and add a one-time cost of living adjustment. It also objects to leaving the §§ 381.5 and 381.6 rates for non-participants at the current level and requests the Judges revise it to match the increase in the SESAC rate.

    GMR did not file a Petition to Participate in the proceeding. It is allowed to comment, but the Judges need not accept its comments as an “objection” to be weighed. The Judges respectfully acknowledge GMR's concerns, but those concerns cannot be a basis for the Judges to find that there is a reasonable objection to adoption of the rules. The Judges' ability to reject an agreement on the reasonableness of the rates and terms proposed therein is constrained by statute. Specifically, section 801(b)(7)(A)(ii) directs the Judges to adopt proposed agreed rates and terms unless a participant to the proceeding objects.6 The entity objecting to the proposed rates and terms at issue, GMR, did not file a timely petition to participate in this proceeding, and it does not qualify as a participant to the proceeding.7 Therefore, having received no objections to the reasonableness of the proposed rates and terms from a participant in this proceeding, the Copyright Royalty Judges adopt with one minor revision the final regulations as published on November 3, 2017, which set the rates and terms for the section 118 statutory license for the period 2018 through 2022.

    6 The Register of Copyrights has opined that the statutory direction does not imply or require that the Judges must adopt proposed regulations that are inherently contrary to law. See 78 FR 47421.

    7 In the Cable Sports Rule proceeding, docket number 15-CRB-0010-CA-S (Sports Rule Proceeding), the Judges gave the comments of non-participant Major League Soccer (“MLS”) more consideration by soliciting reply comments because the settlement in that proceeding excluded MLS from any royalty consideration. 82 FR 44368. In this proceeding, the settling parties proposed a rate for non-settling entities that would cover non-participant GMR.

    List of Subjects in 37 CFR Part 381

    Copyright, Music, Radio, Television, Rates.

    Final Regulations

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

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

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

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

    The revision reads as follows:

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

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

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

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

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

    (i) Music fees.

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

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

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

    (i) Music fees.

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

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

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

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

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

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

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

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

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

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

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

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

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

    The revision reads as follows:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

    The revisions read as follows:

    § 381.7 Recording rights, rates and terms.

    (b) * * *

    (1)(i) * * *

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

    (ii) * * *

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

    (2) * * *

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

    (4) * * *

    2018-2022 (i) Feature $.81 (ii) Feature (concert) (per half hour) 1.69 (iii) Background .41
    7. Amend § 381.10 as follows: a. In paragraph (a), remove “2013” everywhere it appears and in its place add “2018” and remove “2012” and in its place add “2017”; and b. Revise paragraph (b).

    The revision reads as follows:

    § 381.10 Cost of living adjustment.

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

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

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

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

    Dated: December 12, 2017. Suzanne M. Barnett, Chief U.S. Copyright Royalty Judge. Jesse M. Feder, U.S. Copyright Royalty Judge. David R. Strickler, U.S. Copyright Royalty Judge. Carla D. Hayden, Librarian of Congress.
    [FR Doc. 2018-00735 Filed 1-18-18; 8:45 am] BILLING CODE 1410-72-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families 45 CFR Part 1302 RIN 0970-AC63 Secretarial Determination To Lower Head Start Center-Based Service Duration Requirement AGENCY:

    Office of Head Start (OHS), Administration for Children and Families (ACF), Department of Health and Human Services (HHS).

    ACTION:

    Secretarial determination on Head Start center-based service duration requirements; waiver.

    SUMMARY:

    With this document, the Secretary exercises his authority to waive the August 1, 2019 Head Start center-based service duration requirements, effectively lowering this requirement from 50 percent to 0 percent. However, the requirement that Early Head Start programs provide 1,380 annual hours of planned class operations for all center-based enrollment by August 1, 2018 remains in effect.

    DATES:

    This waiver is effective January 19, 2018.

    ADDRESSES:

    Office of Head Start, Mary Switzer Bldg., 330 C Street SW, Washington, DC.

    FOR FURTHER INFORMATION CONTACT:

    Colleen Rathgeb, Division Director for Planning, Oversight and Policy, Office Head Start, [email protected], (202) 358-3263 (not a toll-free call). Deaf and hearing impaired individuals may call the Federal Dual Party Relay Service at 1-800-877-8339 between 8 a.m. and 7 p.m. Eastern Standard Time.

    SUPPLEMENTARY INFORMATION: Background Information

    In the Improving Head Start for School Readiness Act of 2007, Congress instructed the Office of Head Start to update its Head Start Program Performance Standards (HSPPS) by regulation and ensure that any such revisions in the standards do not result in the elimination of or any reduction in the quality, scope, or types of health, educational, parental involvement, nutritional, social, or other social services. We published a final rule to complete this revision at 45 CFR chapter XIII, subchapter B, on September 6, 2016. This final rule included a provision at § 1302.21(c)(2)(iii) that would require each Head Start center-based program, by August 1, 2019, to provide 1,020 annual hours of planned class operations over the course of at least eight months per year for at least 50 percent of its Head Start center-based funded enrollment. This requirement represents an increase from the existing minimum requirement of 3.5 hours per day, 4 days per week, for 128 days per year, which is equivalent to 448 annual hours. The longer 1,020 annual hour service duration requirement was based on a body of research that suggests individual disadvantaged children benefit from longer exposure to enriching early learning programs than what is provided by the part-day, part-year programs. Research on full-day programs, instructional time, summer learning loss, and attendance all indicate longer service duration is linked with improved child outcomes. Moreover, increased service duration allows teachers more time to provide individualized and content-rich learning that is important for positive child outcomes. However, the research does not provide clarity on an exact threshold or combination of hours and days needed to achieve positive child outcomes.

    We also recognize extended services come at a significant cost for Head Start programs. Without additional funding from Congress to support longer hours of program operations, a requirement to increase service duration so that 50 percent of Head Start center-based slots in each program operate for 1,020 annual hours would result in the Head Start program serving significantly fewer children. Although research points to the benefits of increased service duration for an individual child, research has not answered whether the population as a whole benefits more when fewer children are served for a longer time as compared to more children being served for a shorter time.

    Because future appropriations levels were not known when the HSPPS final rule was published in September 2016, the final rule provided authority for the Secretary to lower the increased Head Start center-based service duration requirements based on an assessment of available funding closer to the requirement's effective date in order to prevent thousands of disadvantaged children not having access to Head Start.

    Authority

    Section 1302.21(c)(3)(i) of the HSPPS final rule allows the Secretary to lower the required percentage of funded enrollment slots for which programs must provide 1,020 annual hours of planned class operations from the 50 percent required in § 1302.21(c)(2)(iii), on or before February 1, 2018, based on an assessment of the availability of sufficient funding to mitigate a substantial reduction in funded enrollment.

    Funding Assessment

    The Secretary has made an assessment that Head Start appropriations are not sufficient to allow the requirement at § 1302.21(c)(2)(iii), for 50 percent of each program's Head Start center-based slots to operate for 1,020 annual hours, to go into effect without resulting in a substantial reduction in funded enrollment.

    Prior to publication of the HSPPS final rule, Congress appropriated $294 million in fiscal year (FY) 2016 to support an increase in hours of program operations across Head Start and Early Head Start. At the time of the FY 2016 funding to support and increased duration, the regulatory requirements were not in effect. Programs that wished to voluntarily increase hours of program operations to 1,020 annual hours for up to 40 percent of their Head Start center-based slots or to 1,380 annual hours for their Early Head Start center-based slots were eligible to submit an application by June 2016 to receive additional funds. Some eligible programs chose not to apply for additional funding. There are programs that currently operate none of their Head Start center-based funded enrollment for 1,020 annual hours. There are also programs that currently operate all of their Head Start center-based funded enrollment for 1,020 hours or longer. These requirements are minimums, and programs could choose to operate some slots longer each day and/or for more days per year.

    In the HSPPS final rule, we estimated the cost for programs to implement the 50 percent service duration requirement to be $535 million. Since the publication of the final rule in September 2016, when Head Start programs were notified of the future requirements to increase center-based service duration to 1,020 annual hours, no additional funds have been appropriated to support increases in service duration. While we requested funds to support additional increases in service duration in FY 2017, Congress did not further increase Head Start appropriations for this purpose.

    HHS has conducted an assessment of available funding and the current percentages of slots individual programs currently operate at 1,020 annual hours. Based on this assessment, we estimate that without additional funding, implementation of the requirement at § 1302.21(c)(2)(iii) for each program to operate 50 percent of its Head Start center-based slots for 1,020 annual hours would result in a loss of approximately 41,000 Head Start slots, which represents roughly five percent of existing Head Start slots. The FY 2018 President's Budget did not request an increase in appropriations to support increases in service duration. We do not expect sufficient funding to become available in time for grantees to meet the current HSPPS standard.

    Conclusion

    Under § 1302.21(c)(3)(i), the Secretary has made a determination that there is not sufficient funding available to mitigate a substantial reduction in funded enrollment resulting from the requirement described in § 1302.21(c)(2)(iii), and hereby waives the requirement that 50 percent of a program's Head Start center-based program's funded enrollment that must operate for 1,020 annual hours of planned class operations by August 1, 2019, effectively lowering the percentage to 0. This determination is effective immediately. Because the HSPPS final rule governs the Secretary's discretion in this matter, the public comment process is not required.

    The service duration requirements for Head Start center-based programs described in § 1302.21(c)(2)(i) and (ii) remain in effect. Under these requirements, a Head Start center-based program must provide, at a minimum, at least 160 days per year of planned class operations if it operates for five days per week, or at least 128 days per year if it operates four days per week. Classes must operate for a minimum of 3.5 hours per day. These requirements are minimums, and programs could choose to operate some slots longer each day and/or for more days per year. The Head Start Act allows programs to request to convert part-day slots to full-day or full-working-day slots. This determination by the Secretary provides local Head Start programs maximum flexibility to determine program schedules that best meet the demonstrated needs in their communities, and ensures low-income children will not lose access to Head Start's comprehensive services and a preschool experience before entering Kindergarten because of a federal requirement. Additionally, the requirement under § 1302.21(c)(1)(i) that Early Head Start programs provide 1,380 annual hours of planned class operations for all center-based enrollment by August 1, 2018 also remains in effect.

    The Secretary's determination under § 1302.21(c)(3)(i) does not affect the Secretary's authority to make a separate determination under § 1302.21(c)(3)(ii) on or before February 1, 2020, to maintain or lower the service duration requirement described in § 1302.21(c)(2)(iv) based on an assessment of the availability of sufficient funding to mitigate a substantial reduction in funded enrollment resulting from that requirement.

    In addition, the Secretary's determination under § 1302.21(c)(3)(i) does not change or affect current processes that allow grantees to request to serve children for longer service duration within existing funding levels as part of the grantee's annual service and enrollment negotiations with the Office of Head Start.

    Dated: January 16, 2018. Eric D. Hargan, Acting Secretary, Department of Health and Human Services.
    [FR Doc. 2018-00897 Filed 1-18-18; 8:45 am] BILLING CODE 4184-01-P
    DEPARTMENT OF TRANSPORTATION Federal Motor Carrier Safety Administration 49 CFR Part 395 Hours of Service of Drivers; Electronic Logging Devices; Limited 90-Day Waiver for Old Dominion and Other Motor Carriers Experiencing Problems Integrating PeopleNet ELD System Updates Into Their Fleet Management Systems AGENCY:

    Federal Motor Carrier Safety Administration (FMCSA), DOT.

    ACTION:

    Grant of waiver.

    SUMMARY:

    FMCSA grants a limited 90-day waiver from the Federal hours-of-service (HOS) regulations pertaining to electronic logging devices (ELDs) for Old Dominion Freight Lines, Inc. (Old Dominion) and other motor carriers in similar situations due to issues concerning the integration of PeopleNet's ELD software into fleet management systems. The Agency has initiated this action in response to a waiver request from Old Dominion.

    DATES:

    This waiver is effective December 18, 2017, and expires on March 18, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Thomas L. Yager, Chief, Driver and Carrier Operations Division, Office of Bus and Truck Standards and Operations, Federal Motor Carrier Safety Administration, 1200 New Jersey Ave. SE, Washington, DC 20590. Email: [email protected] Phone: (614) 942-6477.

    SUPPLEMENTARY INFORMATION:

    Old Dominion has asked for relief from the grandfather provision of the ELD regulations, allowing them to add vehicles to their fleet using software that is not fully compliant with the ELD rule, provided the conditions specified in the waiver are met. FMCSA has determined that granting this waiver to Old Dominion, as well as other similarly situated carriers, is in the public interest and will likely achieve a level of safety that is equivalent to the level that would be achieved absent the waiver, based on the terms and conditions imposed in this document.

    Legal Basis

    The Transportation Equity Act for the 21st Century (TEA-21) (Pub. L. 105-178, 112 Stat. 107, June 9, 1998) provides the Secretary of Transportation (the Secretary) the authority to grant waivers from any of the Federal Motor Carrier Safety Regulations issued under Chapter 313 of Title 49 of the United States Code or 49 U.S.C. 31136, to a person(s) seeking regulatory relief. (49 U.S.C. 31136(e), 31315(a)). The Secretary must make a determination that the waiver is in the public interest and that it is likely to achieve a level of safety that is equivalent to, or greater than, the level of safety that would be obtained in the absence of the waiver. Individual waivers may be granted only for a specific unique, non-emergency event, for a period up to three months. TEA-21 authorizes the Secretary to grant waivers without requesting public comment, and without providing public notice.

    The Administrator of FMCSA has been delegated authority under 49 CFR 1.87(e) to carry out the functions vested in the Secretary by 49 U.S.C. chapter 311, subchapter I and III, relating to commercial motor vehicle programs and safety regulations.

    Background

    Old Dominion began equipping its commercial motor vehicles with PeopleNet AOBRDs in 2010, and by 2011 its entire fleet was equipped with devices which meet the requirements of 49 CFR 395.15. Data from the AOBRDs is transferred directly into the company's fleet management and safety systems, enabling its dispatchers to know precisely where every driver is at any given time and how many hours he/she has available under the Federal hours-of-service rules. This functionality is not required by the AOBRD rules under 49 CFR 395.15 or the ELD requirements under Subpart B of 49 CFR part 395.

    Old Dominion explained that PeopleNet's AOBRD and ELD hardware currently installed in its vehicles, and the systems that will be installed in the near future, will satisfy the ELD mandate after the company implements the transition to PeopleNet's December 15, 2017, software release. However, the new PeopleNet release does not include the necessary means to integrate into Old Dominion's fleet management and safety software.

    Currently, the PeopleNet AOBRD software allows carriers to configure certain sessions. If the settings were not adjustable, the PeopleNet AOBRD would be similar to, but not identical to the FMCSA's ELD technical specifications. Although Old Dominion has configured its settings in the PeopleNet AOBRDs it uses, certain AOBRD software changes must be made by PeopleNet, including:

    • Eliminating the “skip” feature;

    • Limiting the auto-duty driving status change threshold to 5 miles; and

    • Limiting geo-fencing of yards to a 0.5-mile radius.

    When these changes are fully implemented, and the operational controls are in place, the PeopleNet system used by Old Dominion will provide an equivalent level of safety while the integration of the ELD software is completed.

    Old Dominion's Request

    Old Dominion requested a 90-day waiver to permit the company to install and use ELD hours-of-service recording devices (i.e., hardware) running PeopleNet's automatic on-board recording device (AOBRD) software that meets the requirements of 49 CFR 395.15, rather than ELD software that meets the requirements of subpart B to part 395, for any truck added to its fleet on or after December 18, 2017, until the company's fleet management software can be fully integrated with PeopleNet's ELD software. The integration of the hours-of-service data with the fleet management and safety systems will enable the company to achieve a high level of safety oversight of its drivers.

    FMCSA Determination

    Based on the information presented in Old Dominion's request, FMCSA believes it is appropriate to grant a limited 90-day waiver from 49 CFR 395.8(a)(1)(i) and subpart B of 49 CFR part 395, Electronic Logging Devices. The Agency has determined, as required by 49 U.S.C. 31315(a) and the implementing regulations under 49 CFR part 381, that the waiver is in the public interest and that the waiver is likely to achieve a level of safety that is equivalent to, or greater than, the level of safety that would be obtained in the absence of the waiver.

    Public Interest

    FMCSA believes the granting of the waiver is in the public interest, given the scope of Old Dominion's and other companies' operations and their role in delivering cargo that ultimately benefit consumers. In the case of Old Dominion, the company has 228 service centers located throughout the Nation and operates a fleet of more than 8,500 power units. The company employs more than 10,000 company drivers. It is in the public interest to avoid disruptions to Old Dominion and other carriers' operations and, subsequently, a disruption to the movement of a significant amount of freight.

    Safety Equivalency

    FMCSA has determined that the electronic system that Old Dominion will use to monitor its drivers' hours of service during the period of the waiver will achieve a level of safety that is equivalent to, or greater than, the level of safety that would be obtained in the absence of the waiver. The company will not only electronically capture the duty status information for all its drivers, it will also monitor the real-time status of its drivers' compliance with the hours-of-service regulations so that supervisors and dispatchers may intervene immediately if a driver is about to run out of driving or on-duty time.

    Also, with the AOBRD settings outlined in the waiver request, which exceed the minimum required by 49 CFR 395.15, and the commitment by PeopleNet to make associated software changes in its ELD software to disable the “skip feature,” limit the auto-duty driving status change threshold to 5 miles or less, limit the geofencing of yard moves to a 0.5-mile radius or less, and maintaining the Auto-Duty Status Change functions outlined in its petition, we believe the requisite level of safety will be provided during the waiver period. In addition, Old Dominion will continue to compel its short haul drivers that are not required to maintain records of duty status to use the existing AOBRD platform.

    Unique Circumstances

    Consistent with the statutory requirements for waivers, this relief is for a period not in excess of 3 months and is limited in scope and circumstances. FMCSA finds that the challenges Old Dominion described in achieving compliance with the ELD requirements while integrating the PeopleNet ELD software into existing fleet management systems is a unique situation for Old Dominion and other carriers facing similar challenges integrating PeopleNet software into their fleet management systems.

    For the reasons cited above, FMCSA grants Old Dominion, and other motor carriers facing similar challenges integrating PeopleNet ELD software into fleet management systems, a limited three-month waiver from the ELD requirements, subject to the terms and conditions provided below.

    Terms and Conditions of the Waiver

    This waiver covers Old Dominion Inc. and other motor carriers experiencing similar challenges resulting from PeopleNet's software for the period beginning at 12:01 a.m. (ET) on December 18, 2017, continuing through 11:59 p.m. on March 18, 2018.

    Regulatory Provisions Waived

    This waiver is limited strictly to 49 CFR 395.8(a)(1)(i) and subpart B of 49 CFR part 395, Electronic Logging Devices. Old Dominion and other motor carriers with similar situations related to PeopleNet's recent software release, must comply with all other applicable provisions of the Federal Motor Carrier Safety Regulations (FMCSRs) (49 CFR 350-399).

    Restrictions

    Each motor carrier operating under this waiver must ensure that drivers required to maintain a record of duty status (ROD) must do so with a device that meets the requirements of 49 CFR 395.15 concerning automatic on-board recording devices (AOBRDs):

    1. During the waiver period, vehicles may be added to the fleet only if the vehicle is equipped with ELD hardware, capable of running the PeopleNet ELD Software.

    2. The AOBRD must transfer data directly into the motor carrier's fleet management and safety systems, allowing its dispatchers to know precisely where the drivers are at any given time and how many hours he/she has available under the Federal hours-of-service rules.

    3. The motor carrier will use the AOBRD settings similar to those outlined in Old Dominion's waiver request.

    4. PeopleNet system must be modified to disable or adjust the settings as outlined below.

    a. Eliminate the “skip feature”;

    b. Limit the auto-duty driving status change threshold to 5 miles or less; and

    c. Limit the geo-fencing yard time limit to a 0.5-mile radius or less.

    If it is determined that this software has not been changed, this waiver does not apply.

    Notification to FMCSA of Accidents

    Each motor carrier must notify FMCSA within 5 business days of an accident (as defined in 49 CFR 390.5), involving any commercial motor vehicles operating under the terms of this waiver. The notification must include the following information:

    • Date of the accident,

    • City or town, and State, in which the accident occurred, or closest to the accident scene,

    • Driver's name and license number,

    • Vehicle number and State license number,

    • Number of individuals suffering physical injury,

    • Number of fatalities,

    • The police-reported cause of the accident, and

    • Whether the driver was cited for violation of any traffic laws, or motor carrier safety regulations.

    Notification shall be by email to [email protected]

    Preemption of State Requirements

    Consistent with 49 U.S.C. 31315(d), this waiver preempts inconsistent State or local requirements applicable to interstate commerce.

    Issued on: January 11, 2018. Cathy F. Gautreaux, Deputy Administrator.
    [FR Doc. 2018-00842 Filed 1-18-18; 8:45 am] BILLING CODE 4910-EX-P
    83 13 Friday, January 19, 2018 Proposed Rules DEPARTMENT OF AGRICULTURE Office of the Secretary 7 CFR Parts 1220 and 1260 Withdrawal of Certain Proposed Rules and Other Proposed Actions; Correction AGENCY:

    Office of the Secretary, USDA.

    ACTION:

    Withdrawal of proposed rules; Correction.

    SUMMARY:

    This document contains a correction to the withdrawal published on January 4, 2018, titled, Withdrawal of Certain Proposed Rules and Other Proposed Actions. The document incorrectly stated that the proposed rule published on July 15, 2016, under the title Soybean Promotion, Research, and Consumer Information; Beef Promotion and Research; Amendments To Allow Redirection of State Assessments to the National Program; Technical Amendments (Soybean Promotion) is not considered a candidate for final action at this time. This document corrects that statement and makes it known that this rulemaking remains under review.

    DATES:

    The proposed rule published on January 4, 2018 is corrected as of January 19, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Michael Poe, Telephone Number: (202) 720-3323. Email [email protected]

    SUPPLEMENTARY INFORMATION:

    Background

    The Soybean Promotion proposed rule published on July 15, 2016, is among a class of research and promotion orders for which the Office of Management and Budget (OMB) has waived review under Executive Order 12866. As a matter of practice, the Department of Agriculture (USDA) does not create or assign Regulatory Identification Numbers (RIN) for documents that are not reviewed by OMB. In the present case, the Agricultural Marketing Service (AMS) incorrectly created RIN 0581-AD49 for the Soybean Promotion rule on May 26, 2016 and corrected the mistake by withdrawing the RIN on June 23, 2017. RIN 0581-AD49 was listed in the July 15, 2016 publication of the Soybean Promotion rule. Additionally, AMS incorrectly created a second RIN for the same Soybean Promotion rule on March 17, 2017 and corrected this subsequent mistake by withdrawing that RIN on August 31, 2017. The second RIN 0581-AD63 was listed in the January 4, 2018 document. The withdrawals of RIN 0581-AD49 and RIN 0581-AD63 removed the incorrectly created numbers from the Regulatory Information Service Center and Office of Information and Regulatory Affairs Consolidated Information System, but did not affect the underlying rulemaking.

    As stated above, the January 4, 2017 document incorrectly stated that the Soybean Promotion rule is not considered a candidate for final action at this time. This document corrects that statement and makes it known that AMS continues to review the proposed rule and the comments.

    Dated: January 11, 2018. Rebeckah Adcock, Regulatory Reform Officer and Senior Advisor to the Secretary, Office of the Secretary.
    [FR Doc. 2018-00893 Filed 1-18-18; 8:45 am] BILLING CODE 3410-90-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-2017-0653; Airspace Docket No. 17-AWA-2] Proposed Amendment of Class B Airspace; San Francisco, CA AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    This action proposes to modify the San Francisco, CA, Class B airspace area to contain aircraft conducting instrument flight rules (IFR) instrument approach procedures to San Francisco International Airport (SFO), San Francisco, CA. The FAA is taking this action to improve the flow of air traffic, enhance safety, and reduce the potential for midair collision in the SFO Class B airspace area while accommodating the concerns of airspace users. Further, this effort supports the FAA's national airspace redesign goal of optimizing terminal and enroute airspace to reduce aircraft delays and improve system capacity.

    This notice does not constitute either a final decision of the FAA or a re-opening of the FAA's August 6, 2014, final decision for the Northern California (NorCal) Optimization of Airspace and Procedures in the Metroplex (OAPM) project.

    DATES:

    Comments must be received on or before March 20, 2018.

    ADDRESSES:

    Send comments on this proposal to the U.S. Department of Transportation, Docket Operations, 1200 New Jersey Avenue SE, West Building Ground Floor, Room W12-140, Washington, DC 20590-0001; telephone: 1 (800) 647-5527, or (202) 366-9826. You must identify FAA Docket No. FAA-2017-0653 and Airspace Docket No. 17-AWA-2 at the beginning of your comments. You may also submit comments through the internet at http://www.regulations.gov. You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office between 9:00 a.m. and 5:00 p.m., Monday through Friday, except Federal holidays. The Docket Office (telephone 1 (800) 647-5527), is on the ground floor of the building at the above address.

    FAA Order 7400.11B, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. For further information, you can contact the Airspace Policy Group, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-8783. The Order is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of FAA Order 7400.11B at NARA, call (202) 741-6030, or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.

    FOR FURTHER INFORMATION CONTACT:

    Kenneth Ready, Airspace Policy Group, Office of Airspace Services, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-8783.

    SUPPLEMENTARY INFORMATION:

    Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would modify the San Francisco, CA, Class B airspace area to improve the flow of air traffic and enhance safety within the National Airspace System (NAS).

    Comments Invited

    Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, aspects of the proposal.

    Communications should identify both docket numbers (FAA Docket No. FAA-2017-0653 and Airspace Docket No. 17-AWA-2) and be submitted in triplicate to the Docket Management Facility (see ADDRESSES section for address and phone number). You may also submit comments through the internet at http://www.regulations.gov.

    Commenters wishing the FAA to acknowledge receipt of their comments on this action must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket Nos. FAA-2017-0653 and Airspace Docket No. 17-AWA-2.” The postcard will be date/time stamped and returned to the commenter.

    All communications received on or before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this action may be changed in light of comments received. All comments submitted will be available for examination in the public docket both before and after the closing date for comments. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket.

    Availability of NPRMs

    An electronic copy of this document may be downloaded through the internet at http://www.regulations.gov. Recently published rulemaking documents can also be accessed through the FAA's web page at http://www.faa.gov/air_traffic/publications/airspace_amendments/.

    You may review the public docket containing the proposal, any comments received and any final disposition in person in the Dockets Office (see ADDRESSES section for address and phone number) between 9:00 a.m. and 5.00 p.m., Monday through Friday, except Federal holidays. An informal docket may also be examined during normal business hours at the office of the Western Service Center, Federal Aviation Administration, 1601 Lind Ave. SW, Renton, WA 98057.

    Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order 7400.11B, airspace Designations and Reporting Points, dated August 3, 2017, and effective September 15, 2017. FAA Order 7400.11B is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11B lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

    Background

    The FAA issued a final rule establishing the San Francisco, CA, Terminal Control Area (37 FR 21928, October, 17, 1972), Airspace Docket No. 72-WA-10, FR. Doc. 72-17641. As a result of the Airspace Reclassification final rule (56 FR 65638, December 17, 1991) Docket No. 24456, FR Doc. 91-29869, which became effective in 1993, the terms “terminal control area” and “airport radar service area” were replaced by “Class B airspace area” and “Class C airspace area,” respectively. The primary purpose of a Class B airspace area is to reduce the potential for midair collisions in the airspace surrounding airports with high-density air traffic operations by providing an area in which all aircraft are subject to certain operating rules and equipment requirements.

    The SFO Class B airspace area was last modified in 2000 (65 FR 36060, June 7, 2000), Airspace Docket No. 97-AWA-1, FR Doc. 00-14046, using air traffic activity levels from the 1990s, and has not been modified since. The following activities have occurred since then making it appropriate to redesign the current San Francisco Class B airspace.

    • Updates to instrument approach procedure charting criteria.

    • Advances in flight deck technology that allows aircraft automation to manage both the lateral and vertical flight path.

    • Advances in airframe technology, specifically efficiencies in wing design.

    • Industry adoption of “optimized profile descent” procedures that provide a constant angle descent into the terminal area.

    • Industry-wide migration to satellite-based global positioning system (GPS) area navigation procedures from procedures utilizing ground-based navigational facilities.

    In 2014, as part of the Next Generation Air Transportation System (NextGen),1 the FAA completed the NorCal OAPM project. The OAPM initiatives, generally, address airspace congestion, airports in close geographical proximity, and other limiting factors that reduce efficiency in busy metroplex airspace. The NorCal OAPM project included 14 new RNAV STARs, 18 new RNAV SIDs, 2 revised existing RNAV Stars, 22 existing conventional STARs, and 28 existing conventional SIDs. As part of the NorCal OAPM project, the FAA conducted an environmental assessment under the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321, et seq.) and on August 7, 2014 issued its Finding of No Significant Impact (FONSI) and Record of Decision (ROD).

    1 To achieve NextGen goals, the FAA is implementing new Area Navigation (RNAV) and Required Navigation Performance (RNP) air traffic routes and instrument procedures RNAV Standard Instrument Departures (SIDs), RNAV Standard Terminal Arrival Routes (STARs), and RNAV Standard Instrument Approach Procedures (SIAPs) that use emerging technologies and aircraft navigation capabilities. The implementation of RNAV and RNP procedures enables the use of other Performance Based Navigation (PBN) technology in the NAS, and facilitates more efficient procedures such as Optimized Profile Descents (OPD). The FAA complies with the requirements of applicable federal environmental statutes, regulations and FAA procedures, standards and Orders, including community outreach, as appropriate, before it undertakes and implements new procedures or potential modifications to currently published procedures.

    Consistent with the recent NorCal OAPM project, the proposed modifications to the SFO Class B airspace area moves the identification methods of the Class B airspace away from reliance on ground-based navigational aids to utilizing GPS technology and leveraging the increased use of graphical flight system displays. The proposed airspace modifications are based on current lateral flight paths and take into account the NorCal OAPM-implemented satellite-based area navigation procedures at San Francisco International Airport. These NorCal OAPM-based RNAV arrival procedures, known as “Optimized Profile Descents”, utilize a shallow descent angle consistent with today's aircraft design to allow for a more fuel-efficient descent profile. Today's SFO fleet consists of new-generation aircraft such as the B737-NG, B747-400, B777, B787, and the A321, A340, A380. The newer generation of aircraft utilize a more efficient wing design that requires a shallower descent at reduced power levels.

    Moreover, due to limitations of the current SFO Class B airspace configuration, air traffic had to interrupt the optimal profile descent on instrument approach procedures to keep aircraft within Class B airspace while flying published instrument approach procedures, which is contrary to FAA Orders guidance. Modeling of existing traffic flows has shown that the proposed expanded Class B airspace would enhance safety by containing all instrument approach procedures, and associated traffic patterns, within the confines of Class B airspace and better segregate IFR aircraft arriving/departing SFO and visual flight rules (VFR) aircraft operating in the vicinity of the SFO Class B airspace area. The proposed Class B airspace modifications described in this NPRM are intended to address these issues.

    In areas where current Class B airspace is no longer required to contain San Francisco International Airport arrivals or departures, the FAA is proposing to remove that airspace from the proposed Class B airspace modifications and re-designate it as Class E or Class G airspace, as appropriate.

    Pre-NPRM Public Input

    In 2015, the FAA initiated action to form an Ad Hoc Committee to seek input and recommendations from representatives of effected aviation segments for the FAA to consider in designing proposed modifications to the SFO Class B airspace area. Participants in the committee included representatives from the National Business Aviation Association (NBAA), Aircraft Owners and Pilots Association (AOPA), Airlines Pilot Association (ALPA), California Pilots Association, San Carlos Airport Association, Palo Alto Pilots Association, California Department of Transportation, California Highway Patrol, United and Southwest Airlines, City of Palo Alto, United Sates Coast Guard, San Mateo County Airports, San Francisco Airport Commission, and Hewlett Packard Enterprise. The Ad Hoc Committee report included general group consensus recommendations and individual recommendations. A copy of the report has been placed in the docket for this rulemaking action.

    As announced in the Federal Register (81 FR 78756, November 9, 2016), FR Doc. 2016-27089, three informal airspace meetings were held; one each on January 30, 2017, at the Burlingame Public Library, Burlingame, CA; on January 31, 2017, at the Martin Luther King Library, San Jose, CA; and on February 1, 2017, at the Port of Oakland Building, Oakland, CA. These meetings provided interested airspace users with an opportunity to present their views and offer recommendations regarding the planned modification of the SFO Class B airspace area.

    All substantive airspace recommendations made by the Ad Hoc Committee and public comments received as a result of the informal airspace meetings, regarding proposed modifications to the SFO Class B airspace area, were considered in developing this proposal.

    Discussion of Ad Hoc Committee Recommendations and Comments

    The Ad Hoc Committee recommended the FAA modify the design of the current Class B surface area (Area A) by moving the southern boundary slightly north to follow Interstate 280 and defining the northern and eastern boundaries using a DME arc off of the SFO VOR/DME.

    The FAA partially adopted this recommendation by moving the Area A southern boundary northward, to the extent practicable, but is proposing to describe the northern and eastern boundaries recommended arc using geographic coordinates to move the identification of the SFO Class B airspace area away from a reliance on using ground-based navigational aids in favor of using GPS technology and leveraging the increased use of graphical flight system displays.

    The Ad Hoc Committee suggested the FAA review the design of the proposed Area N further for opportunities of greater stratification or subdivision. They noted the underlying area included high terrain and that it would benefit general aviation to have higher altitudes to operate beneath the Class B airspace and offered that a new fix on the SERFR Two STAR, with an altitude crossing restriction of at or above 8,000 feet, should be considered as a method to provide a higher floor altitude within this area.

    The FAA reviewed the proposed Area N as suggested and adopted this recommendation; adjusting the proposed Area N floor of Class B airspace to be 8,000 feet MSL, accordingly. Additionally, to ensure the SFO SERFR STAR is contained within the existing Class B airspace area, the FAA plans to add an altitude crossing restriction of “at or above 8,000 feet MSL” approximately 8 miles southeast of the EDDYY waypoint.

    The Ad Hoc Committee also suggested the FAA evaluate the design of proposed Area Q further for consolidation [presumably with other proposed Class B sub-areas] and to align the eastern boundary with a VOR/DME arc and/or prominent geographical landmarks (preferably both). The Ad Hoc Committee recommended adjusting the eastern boundary by relocating it to the southern edge of Lake Del Valle and proceed southbound to Mount Hamilton or using the SFO 33-mile DME arc.

    The FAA does not agree with this recommendation. The eastern boundary of Area Q is located where IFR arriving aircraft are descending via the DYMND and YOSEM STARs passing through 10,000 feet MSL. Moving the boundary westward to Lake Del Valle is not considered operationally feasible by air traffic control. Additionally, relying on an arc off the SFO DME would result in an unnecessary increase in the size of Class B airspace. However, the FAA plans to establish VFR waypoints at Cedar Mountain and Lick Observatory (atop Mount Hamilton) to aid VFR pilots with visually identifying the lateral confines of the proposed Class B airspace.

    In addition to the three specific recommendation above, the Ad Hoc Committee went on to offer a number of general recommendations that included amending the Oakland Class C airspace area concurrently with this action, disclosing whether any proposed airspace changes are the result of a trend of Traffic alert and Collision Avoidance System (TCAS) resolution advisories (RAs), publishing SFO Class B airspace amendments to coincide with VFR Class B Enhancement Graphic initiatives, defining new VFR transition routes to circumnavigate Class B airspace areas using prominent geographic landmarks and VFR waypoints, including an insert depicting commonly used Oakland overflight routes on the SFO Flyway Planning Chart, defining the Class B airspace sub-areas using VOR/DME radial and arcs and/or prominent geographic landmarks, containing Class B airspace areas with the associated Mode C veil, depicting the STAR/SID fix closest to the outer boundary of Class B airspace should be show on VFR Flyway Planning Charts and IFR Enroute Charts, and conducting extensive outreach prior to informal airspace meetings to ensure comment periods are adequately advertised.

    The FAA has considered the general recommendations provided by the Ad Hoc Committee and offers the following. Modifying the Oakland Class C airspace concurrently with this action is outside the scope of this action. With respect to the use of TCAS RA reports or trends, they are generally a consideration in many Class B amendment actions; however, they were not used to justify this proposed action. To the recommendations associated with the VFR Class B Enhancement Graphic initiatives, defining new VFR transition routes, depicting commonly used overflight routes on Flyway Planning Charts, defining Class B airspace sub-areas using radials, arcs, or geographic landmarks, depicting STAR/SID fixes closest to the outer boundary of Class B airspace areas, and conducting extensive outreach prior to informal airspace meetings, they all have merit and the FAA plans to consider the recommendations as provided. Lastly, for the recommendation addressing containment of Class B airspace areas within associated Mode C veils, further consideration is required since Class B airspace areas and the Mode C veil around Class B primary airports are not dependent on each other.

    Several recommendations from individual Ad Hoc Committee members raised concerns/issues regarding the development of air traffic management tools, perceived concerns over existing instrument procedures and/or air traffic control services at SFO, concurrent modifications to Oakland Class C airspace, regulatory airspeed restrictions, and general complaints about the philosophy, policy, and processing actions underpinning the rulemaking requirements for modifying Class B airspace areas. These concerns/issues are not addressed as part of this proposal.

    Discussion of Informal Airspace Meeting Comments

    As a result of the informal airspace meetings, the FAA received comments from 51 commenters, including 3 organizations that represented one or more groups of individuals.

    Thirty-four comments were received from 28 individuals and one organization representing multiple citizen groups raising concerns with respect to potential noise impacts as a result of the proposed airspace changes. Most of the comments cited a recent increase in noise due to changes in air traffic flight patterns within the last year.

    The Class B airspace redesign development process is intended to identify and address safety concerns associated with the proposed airspace configuration. The designation or modification of this proposed airspace does not create an adverse environmental impact. The FAA complies with the requirements of applicable federal statutes, regulations and its internal Orders, including evaluating noise impacts associated with all new air traffic procedures and potential modifications to currently published procedures. Therefore, environmental evaluations and considerations are followed and undertaken before implementing instrument flight procedures, including when appropriate Diverse Vector Areas, not the designation of controlled airspace areas to contain those procedures. The FAA is continuing its work on an initiative requested by three congressional representatives to address existing noise concerns in Santa Cruz, Santa Clara, San Mateo, and San Francisco Counties. Additionally, concerned citizens can contact the FAA's Aviation Noise Ombudsman to submit existing noise complaints at email [email protected]

    Eight commenters cited an expected negative impact on glider and general aviation practice operations near Mount Diablo due to the eastward expansion of Class B airspace.

    The FAA adjusted the proposed Class B airspace boundaries in the vicinity of the glider and general aviation practice operations near Mount Diablo by moving the boundaries westward to mitigate these concerns, as much as possible, while still ensuring containment of IFR arrival aircraft within Class B airspace. Additionally, the floor of the proposed Class B airspace near Mount Diablo was retained at 6,000 feet MSL in one sub-area and raised from 6,000 feet MSL to 7,000 feet MSL in another to accommodate the glider and general aviation aircraft operations near the proposed Class B airspace area.

    Eight commenters expressed a general dissatisfaction with the informal public meeting schedule, location, and/or briefing materials.

    The FAA held three informal airspace meetings on separate days and in different locations to seek public input from different communities underlying the proposed Class B airspace to aid in developing this proposed modification of the SFO Class B airspace area. The FAA recognizes the benefits associated with hosting informal airspace meetings and seeking input on airspace actions from the public; requiring notices of informal airspace meetings be sent 60 to 90 days prior to the first meeting to all known licensed pilots, state aviation agencies, airport manager/operators, and operators of parachute, sailplane, ultra-light, and balloon clubs within a 100-mile radius of the primary airport for Class B airspace actions. As a result, these comments will be retained and considered in the planning of future informal public meetings to help the public better understand proposed airspace changes and to enhance substantive public input for future airspace actions.

    Five commenters expressed support for the continuation and development of more VFR corridors to allow VFR pilots to transition the San Francisco Bay area without entering the Class B airspace. However, one of the five commenters also recommended that the FAA develop a VFR corridor with lateral and vertical paths through the Class B airspace area. With the exception of the commenter that actually recommended the FAA include a VFR Flight Corridor through SFO Class B airspace, the FAA read the other four commenters' inputs to actually be addressing support for the continuation of VFR flyways and not VFR corridors.

    The FAA appreciates the support for retaining the VFR flyways that circumnavigate the SFO Class B airspace area, but does not agree with developing a VFR corridor through the Class B airspace. The current Class B airspace area has five VFR flyways that surround the Class B surface area and reside under the Class B shelves. Three of the five VFR flyways also have alternate transitions to further support circumnavigating around and under Class B airspace. With the proposed modifications to the SFO Class B airspace area, four flyways will remain unchanged, but one VFR flyway, located southeast of SFO, will require a 400-foot reduction of the suggested altitude, from below 2,500 to below 2,100, for the portion of the flyway that falls under proposed new Area F. The FAA believes that these existing VFR flyway options are sufficient to continue supporting the VFR aircraft flying in the vicinity of SFO.

    Four commenters cited safety concerns for VFR aircraft operations beneath the floor of the proposed Class B airspace due to congestion, proximity to terrain, and airspace for a safe glide distance over San Francisco Bay.

    The FAA is taking action to modify the current class B airspace to contain all instrument procedures at SFO and the aircraft flying those procedures within Class B airspace, once they have entered it, to overcome the IFR aircraft entering, exiting, and re-entering Class B airspace while flying published instrument approaches and associated traffic patterns. The FAA acknowledges that some compression will occur and that non-participating VFR aircraft will have to fly above, below, or circumnavigate the proposed SFO Class B airspace in order to remain clear of it should they decide not to seek Class B airspace services. The floors of the proposed Class B airspace sub-areas were adjusted in most of the areas to the extent possible to raise the floor of the Class B airspace and mitigate the concerns. All aircraft operating beneath or in the vicinity of the SFO Class B airspace area are expected to continue to comply with the regulatory requirements of Title 14 of the Code of Federal Regulations (14 CFR) § 91.111, titled Operating Near Other Aircraft, to avoid creating a collision hazard with other aircraft operating in the same airspace. Additionally, all aircraft operating in the same areas noted above are expected to continue complying 14 CFR § 91.113, titled Right-of-Way Rules: Except Water operations, to “see and avoid” other aircraft as well. The FAA believes that continued general aviation pilot compliance with established flight rules regulatory requirement, and these two regulations specifically, will overcome the safety concerns raised by the commenters.

    Two commenters stated the use of geographic coordinates—instead of distances from navigation aids (NAVAIDs) or other reference points to define the individual airspace areas—would make navigation around, and the avoidance of, Class B airspace more difficult.

    The FAA acknowledges the concerns of the commenters, but has determined the use of geographic coordinates to define the Class B airspace area enables a much smaller area of Class B airspace to be designated or established to contain all IFR instrument procedures and arrival/departure operations. Further, the FAA believes the current trend toward increased use of GPS navigation and position tracking will mitigate the concern.

    Two commenters suggested the use of waypoints to facilitate the identification of the boundaries of Class B airspace areas.

    The FAA plans to adopt the commenters' suggestion. The development, designation, and charting of waypoints will follow established Aeronautical Information Services (AIS) processing requirements while the rulemaking requirements for proposing and designating Class B airspace modifications are accomplished. Collectively, that will result in the FAA using waypoints to identify Class B airspace boundaries.

    One comment was received from a user group associated with the United States Hang Gliding and Paragliding Association, including 39 individual names, outlining the negative impact on hang glider operations within the Golden Gate National Recreation Area, and requesting specific adjustments.

    The FAA was able to partially adopt the Association's requested adjustments by amending the western boundary of the proposed Class B surface area airspace along the shore to minimize the impact to hang glider operations at the Fort Funston and Pacifica hang gliding and paragliding sites in the greater bay area, to the extent possible.

    One commenter expressed a safety concern that the expansion of Class B airspace into the Sunnyvale, CA area will result in aircraft arriving at San Francisco and San Jose using the same airspace simultaneously and may present a hazard to residents below.

    The FAA does not agree. The proposed modifications to the SFO Class B airspace area and the FAA's August 7, 2014 issuance of NorCal OAPM procedures for operations within the San Francisco terminal area were designed to keep aircraft arriving and departing at the San Francisco and San Jose International Airports segregated; ensuring safe and efficient arrival and departure operations at both locations.

    One commenter questioned whether the FAA can regulate airspace more than 12 miles off the coast of the United States.

    As part of this proposal relates to the navigable airspace outside the United States, this notice is submitted in consonance with the ICAO International Standards and Recommended Practices. Article 12 of the Chicago Convention provides that over the high seas the rules in force shall be those established under the Convention. Applicability of International Standards and Recommended Practices by the Air Traffic Service, FAA, in areas outside domestic airspace of the United States is governed by Annexes 2 and 11 to the Convention on International Civil Aviation, which pertain to the rules of the air and the establishment of air navigation facilities and services necessary to promoting the safe, orderly, and expeditious flow of civil air traffic. Their purpose is to insure that civil flying on international air routes is carried out under uniform conditions designed to improve the safety and efficiency of air operations.

    The International Standards and Recommended Practices in Annex 11 apply in those parts of the airspace under the jurisdiction of a contracting state, derived from the International Civil Aviation Organization (ICAO), wherein air traffic services are provided and also whenever a contracting state accepts the responsibility of providing air traffic services over high seas or in airspace of undetermined sovereignty. A contracting state accepting such responsibility may apply the International Standards and Recommended Practices to civil aircraft in a manner consistent with that adopted for airspace under its domestic jurisdiction.

    The Proposal

    The FAA is proposing an amendment to Title 14 of the Code of Federal Regulations (14 CFR) part 71 to modify the SFO Class B airspace area. This action (depicted on the attached graphic) moves away from the three concentric circle (upside down wedding cake) design configuration and is redrawn based on arrival and departure routes into and out of SFO. Using this design approach allows the FAA to minimize the Class B airspace necessary to contain instrument procedures within Class B airspace for aircraft arriving and departing SFO and to re-designate current Class B airspace as Class E or Class G to make it available for nonparticipant aircraft circumnavigating the Class B airspace area. Additionally, the proposed modifications would better segregate IFR aircraft arriving/departing SFO and VFR aircraft operating in the vicinity of the SFO Class B airspace area. The proposed modifications to the SFO Class B airspace area are discussed below.

    Area A. The FAA proposes to modify the current Area A by moving the southern boundary northward to accommodate local hang glide operations, as much as possible. Minor modifications to the current Area A northeast boundary are also incorporated by using geographic coordinates to define the surface area in the proposed legal description.2 The new Area A would continue to extend upward from the surface, to and including 10,000 feet MSL.

    2 The Ad Hoc Committee found the modified design of existing Area A could be improved by the southern boundary being relocated slightly north to follow Interstate 280. Additionally, the northern and eastern boundary should be defined by a DME arc off of the SFO VOR/DME. The FAA agreed with this recommendation and has adjusted Area A in the NPRM to reflect geographic latitudes and longitudes to mimic an arc.

    Area B. The FAA proposes to modify the current Area B by moving the southern boundary northward, the eastern boundary westward, and incorporating a small portion of the current Area F. The proposed Area B would also lower the floor of Class B airspace from the current Area B from 1,500 MSL to 1,400 MSL and from the current Area F portion from 2,100 feet MSL to 1,400 feet MSL. The new Area B would extend upward from 1,400 feet MSL, to and including 10,000 feet MSL.

    Area C. The FAA proposes to establish a new Area C, located to the west of SFO beyond the proposed Area A, by incorporating small portions of the current Area F and current Area I. The proposed Area C would lower the floor of Class B airspace from the current Area F portion from 2,100 feet MSL to 1,600 feet MSL and raise the floor of Class B airspace from the current Area I portion from 1,500 feet MSL to 1,600 feet MSL. The new Area C would extend upward from 1,600 feet MSL, to and including 10,000 feet MSL.

    Area D. The FAA proposes to establish a new Area D, located to the west of SFO beyond the proposed Area C, by incorporating small portions of the current Area F, current Area G, and current Area I. The proposed Area D would retain the floor of Class B airspace from the current Area F portion at 2,100 feet MSL, lower the floor of Class B airspace from the current Area G portion from 3,000 feet MSL to 2,100 feet MSL, and raise the floor of Class B airspace from the current Area I portion from 1,500 feet MSL to 2,100 feet MSL. The new Area D would extend upward from 2,100 feet MSL, to and including 10,000 feet MSL.

    Area E. The FAA proposes to establish a new Area E, located northwest of SFO extending clockwise to east of SFO beyond the proposed Area A, by incorporating a sliver of the current Area A and small portions of the current Area F and current Area G. The proposed Area E would raise the floor of Class B airspace from the current Area A portion from the surface to 2,100 feet MSL, retain the floor of Class B airspace from the current Area F portion at 2,100 feet MSL, and lower the floor of Class B airspace from the current Area G portion from 3,000 feet MSL to 2,100 feet MSL. The new Area E would extend upward from 2,100 feet MSL, to and including 10,000 feet MSL.

    Area F. The FAA proposes to establish a new Area F, located to the southeast of SFO beyond the proposed Area B, by incorporating small portions of the current Area B, current Area C, current Area F, and current Area G. The proposed Area F would raise the floor of Class B airspace from the current Area B portion from 1,500 feet MSL to 2,100 feet MSL, lower the floor of Class B airspace from the current Area C portion from 2,500 feet MSL to 2,100 feet MSL and current Area G portion from 3,000 feet MSL to 2,100 feet MSL, and retain the floor of Class B airspace from the current Area F portion at 2,100 feet MSL. The new Area F would extend upward from 2,100 feet MSL, to and including 10,000 feet MSL.

    Area G. The FAA proposed to establish a new Area G, located to the northwest of SFO beyond the proposed Area D and proposed Area E, by incorporating small portions of the current Area A, current Area F, current Area G, current Area H, and current Area I. The proposed Area G would raise the floor of Class B airspace from the current Area A portion from the surface to 3,000 feet MSL, current Area F portion from 2,100 feet MSL to 3,000 feet MSL, and current Area I portion from 1,500 feet MSL to 3,000 feet MSL; retain the floor of Class B airspace from the current Area G portion at 3,000 feet MSL; and lower the floor of Class B airspace from the current Area H portion from 4,000 feet MSL to 3,000 feet MSL. Additionally, the FAA would be establishing a sliver of Class B airspace beyond the current Area H external SFO Class B boundary. The new Area G would extend upward from 3,000 feet MSL, to and including 10,000 feet MSL.

    Area H. The FAA proposes to establish a new Area H, located southeast of SFO beyond the proposed Area E and proposed Area F, by incoporating small portions of the current Area A, current Area B, current AreaC, current Area D, current Area F, and current Area G. The proposed Area H would raise the floor of Class B airspace from the current Area A portion from the surface to 3,000 feet MSL, current Area B portion from 1,500 feet MSL to 3,000 feet MSL, current Area C portion from 2,500 feet MSL to 3,000 feet MSL, and current Area F portion from 2,100 feet MSL to 3,000 feet MSL; retain the floor of Class B airspace from the current Area G portion at 3,000 feet MSL; and lower the floor of Class B airspace from the current Area D portion from 4,000 feet MSL to 3,000 feet MSL. The new Area H would extend upward from 3,000 feet MSL, to and including 10,000 feet MSL.

    Area I. The FAA proposes to establish a new Area I, located north of SFO extending clockwise around and to the west of SFO beyond the proposed Area E, proposed Area G, and proposed Area H, by incorporating small portions of the current Area A, current Area C, current Area D, current Area E, current Area F, current Area G, current Area H, current Area I, and current Area K. The proposed Area I would raise the floor of Class B airspace from the current Area A portion from the surface to 4,000 feet MSL, current Area C portion from 2,500 feet MSL to 4,000 feet MSL, current Area F portion from 2,100 feet MSL to 4,000 feet MSL, current Area G portion from 3,000 feet MSL to 4,000 feet MSL, current Area I portion from 1,500 feet MSL to 4,000 feet MSL; retain the floor of Class B airspace from the current Area D portion and current Area H portion at 4,000 feet MSL; and lower the floor of Class B airspace from the slivers of the current Area E portion from 6,000 feet MSL to 4,000 feet MSL and current Area K portion from 5,000 feet MSL to 4,000 feet MSL. Additionally, the FAA would be establishing Class B airspace beyond the current Area E and current Area H external SFO Class B boundaries. The new Area I would extend upward from 4,000 feet MSL, to and including 10,000 feet MSL.

    Area J. The FAA proposes to establish a new Area J, located north of SFO beyond the proposed Area G and proposed Area I, by incorporating small portions of the current Area D, current Area E, current Area G, and current Area H. The proposed Area J would raise the floor of Class B airspace from the current Area G portion from 3,000 feet MSL to 5,000 feet MSL and the current Area D portion and current Area H portion from 4,000 feet MSL to 5,000 feet MSL, and lower the floor of Class B airspace from the current Area E portion from 6,000 feet MSL to 5,000 feet MSL. Additionally, the FAA would be establishing Class B airspace beyond the current Area D, current Area E, and current Area G external SFO Class B boundaries. The new Area J would extend upward from 5,000 feet MSL, to and including 10,000 feet MSL.

    Area K. The FAA proposes to establish a new Area K, located north of SFO beyond the proposed Area I and proposed Area L (described below), by incorporating small portions of the current Area D and current Area E. The proposed Area K would raise the floor of Class B airspace from the current Area D portion from 4,000 feet MSL to 5,000 feet MSL and retain the floor of Class B airspace from the current Area E portion at 6,000 feet MSL. Additionally, the FAA would be establishing a sliver of Class B airspace beyond the current Area E external SFO Class B boundary. The new Area K would extend upward from 6,000 feet MSL, to and including 10,000 feet MSL.

    Area L. The FAA proposes to establish a new Area L, located northeast of SFO beyond the proposed Area I, by incorporating small portions of the current Area D and current Area E. The proposed Area L would raise the floor of Class B airspace from the current Area D portion from 4,000 feet MSL to 5,000 feet MSL and lower the floor of Class B airspace from the current Area E portion from 6,000 feet MSL to 5,000 feet MSL. The new Area L would extend upward from 5,000 feet MSL, to and including 10,000 feet MSL.

    Area M. The FAA proposes to establish a new Area M, located south of SFO beyond the proposed Area I, by incorporating portions of the current Area D, current Area E, current Area G, current Area J, and current Area K. The proposed Area M would raise the floor of Class B airspace from the current Area D portion from 4,000 feet MSL to 6,000 feet MSL, current Area G portion from 3,000 feet MSL to 6,000 feet MSL, and current Area K portion from 5,000 feet MSL to 6,000 feet MSL; retain the floor of Class B airspace from the current Area E portion at 6,000 feet MSL; and lower the floor of Class B airspace from the current Area J from 8,000 feet MSL to 6,000 feet MSL. Additionally, the FAA would be establishing Class B airspace beyond the current Area E and current Area J external SFO Class B boundaries. The new Area M would extend upward from 6,000 feet MSL, to and including 10,000 feet MSL.

    Area N. The FAA proposes to establish a new Area N, located south-southeast of SFO beyond the proposed Area M, by incorporating small portions of the current Area E and current Area J. The proposed Area N would raise the floor of Class B airspace from the current Area E portion from 6,000 feet MSL to 8,000 feet MSL and retain the floor of Class B airspace from the current Area J portion at 8,000 feet MSL. Additionally, the FAA would be establishing Class B airspace beyond the current Area J external SFO Class B boundary. The new Area N would extend upward from 8,000 feet MSL, to and including 10,000 feet MSL and have a higher floor from Area M due to accommodate VFR aircraft operating in higher terrain below the Class B airspace.3

    3 The Ad Hoc Committee found the design of Area N should be further reviewed by the FAA for opportunities of greater stratification or subdivision. They noted the underlying area included high terrain and that it would benefit general aviation to have higher altitudes to operate beneath the Class B airspace and offered that a new fix on the SERFR Two STAR, with an altitude crossing restriction of “at or above 8,000 feet” approximately 8 miles southeast of the EDDYY waypoint, should be considered as a method to provide a higher floor altitude. To clarify, the FAA is in the process of amending SERFR2 for containment within the existing Class Bravo airspace. However, the FAA reviewed the proposed Area N as suggested and adopted this recommendation; adjusting the proposed Area N floor of Class B airspace to extend upward from 8,000 feet MSL.

    Area O. The FAA proposes to establish a new Area O, located northeast of SFO beyond the proposed Area L, within a portion of the current Area E. The proposed Area O would raise the floor of Class B airspace from the current Area E portion from 6,000 feet MSL to 7,000 feet MSL to accommodate VFR traffic below due to higher terrain (Mount Diablo) and frequent use by general aviation aircraft. Additionally, the FAA would be establishing a sliver of Class B airspace beyond the current Area E external SFO Class B boundary. The new Area O would extend upward from 7,000 feet MSL, to and including 10,000 feet MSL.

    Area P. The FAA proposes to establish a new Area P, located east-southeast of SFO beyond the proposed Area M, within a portion of the current Area J. The proposed Area P would lower the floor of Class B airspace from the current Area J portion from 8,000 feet MSL to 7,000 feet MSL. Additionally, the FAA would be establishing a small portion of Class B airspace beyond the current Area J external SFO Class B boundary. The new Area P would extend upward from 7,000 feet MSL, to and including 10,000 feet MSL.

    Area Q. The FAA proposes to establish a new Area Q, located east of SFO beyond the proposed Area I and proposed Area P, within a portion of the current Area E and current Area J. The proposed Area P would raise the floor of Class B airspace from the current Area E portion from 6,000 feet MSL to 8,000 feet MSL and retain the floor of Class B airspace from the current Area J portion at 8,000 feet MSL. Additionally, the FAA would be establishing Class B airspace beyond the current Area E and current Area J external SFO Class B boundaries to capture delay vectoring for runway 10 and 19 arrivals.4 The new Area Q would extend upward from 8,000 feet MSL, to and including 10,000 feet MSL. Proposed Area Q would expand the Class B airspace east of SFO beyond 30 NM.

    4 The Ad Hoc Committee suggested the FAA evaluate Area Q further for consolidation and to align the eastern boundary with a VOR/DME arc and/or prominent landmarks (preferably both). The Ad Hoc Committee urged the eastern boundary be relocated to the southern edge of Lake Del Valle proceeding southward to Mount Hamilton or use the SFO 33-mile DME arc. The FAA disagreed. The eastern boundary of Area Q is located where aircraft descending via the DYMND and YOSEM STARs pass through 10,000 feet MSL, moving the boundary westward to Lake Del Valle is not operationally feasible, and relying on an arc would result in an unnecessary increase in the size of Class B airspace. However, the FAA will establish VFR waypoints at Cedar Mountain and Lick Observatory (atop Mount Hamilton) to aid VFR pilots visually identifying the lateral confines of the Class B airspace.

    Paperwork Reduction Act

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

    Regulatory Evaluation

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

    Department of Transportation Order DOT 2100.5 prescribes policies and procedures for simplification, analysis, and review of regulations. If the expected cost impact is so minimal that a proposed or final rule does not warrant a full evaluation, this order permits that a statement to that effect and the basis for it to be included in the preamble if a full regulatory evaluation of the cost and benefits is not prepared. Such a determination has been made for this proposed rule. The reasoning for this determination follows:

    It is appropriate to redesign SFO Class B airspace for reasons described earlier including the availability of new procedures such as the use of “Optimized Profile Descents,” advances in technology; migration to GPS from ground based navigation facilities and updated charting criteria.

    This regulation proposes to modify the San Francisco, CA, (SFO) Class B airspace area to improve the flow of air traffic, enhance safety and reduce the potential for midair collision in the SFO Class B airspace area while accommodating the concerns of airspace users. This effort supports the FAA's national airspace redesign goal of optimizing terminal and enroute airspace to reduce aircraft delays and improve system capacity.

    The Class B airspace redesign may enhance opportunities for more fuel-efficient descent profiles.

    Further, the SFO Class B airspace redesign would enhance safety by containing IFR traffic arriving and departing SFO within the confines of Class B airspace and would better segregate IFR and VFR aircraft.

    Finally, the regulation proposes returning current Class B airspace that is not being used for SFO airport arrivals or departures to the NAS.

    Because it proposes to modify SFO Class B airspace to take advantage of more fuel efficient approaches and optimize terminal and enroute airspace to reduce delays and improve system capacity, the rule is expected to be a minimal cost rule with the potential to be minimal cost saving.

    FAA has, therefore, determined that this proposed rule is not a “significant regulatory action” as defined in section 3(f) of Executive Order 12866, and is not “significant” as defined in DOT's Regulatory Policies and Procedures.

    Regulatory Flexibility Determination

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

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

    However, if an agency determines that a rule is not expected to have a significant economic impact on a substantial number of small entities, section 605(b) of the RFA provides that the head of the agency may so certify and a regulatory flexibility analysis is not required. The certification must include a statement providing the factual basis for this determination, and the reasoning should be clear.

    The redesign of the SFO Class B airspace will not affect a substantial number of small entities because the redesign does not alter or amend any existing flight path at SFO. Any change to an existing flight path would be achieved through a separate action. Therefore, the expected outcome, if any, would be a minimal economic impact on small entities affected by this rulemaking action. The FAA requests comments.

    If an agency determines that a rulemaking will not result in a significant economic impact on a substantial number of small entities, the head of the agency may so certify under section 605(b) of the RFA. Therefore, as provided in section 605(b), the head of the FAA certifies that this rulemaking will not result in a significant economic impact on a substantial number of small entities.

    International Trade Impact Assessment

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

    Unfunded Mandates Assessment

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

    List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

    The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:

    PART 71—DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR TRAFFIC SERVICE ROUTES; AND REPORTING POINTS 1. The authority citation for part 71 continues to read as follows: Authority:

    49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

    § 71.1 [Amended]
    2. The incorporation by reference in 14 CFR 71.1 of the FAA Order 7400.11B, Airspace Designations and Reporting Points, dated August 3, 2017, and effective September 15, 2017, is amended as follows: Paragraph 3000 Subpart B—Class B Airspace. AWP CA B San Francisco, CA San Francisco International Airport (Primary Airport) (Lat. 37°37′08″ N., long. 122°22′32″ W.)

    Boundaries.

    Area A. That airspace extending upward from the surface to and including 10,000 feet MSL within the area bounded by a line beginning at lat. 37°41′40″ N, long. 122°29′11″ W; to lat. 37°42′32″ N, long. 122°28′07″ W; to lat. 37°43′08″ N, long. 122°27′05″ W; to lat. 37°43′31″ N, long. 122°26′10″ W; to lat. 37°43′52″ N, long. 122°25′04″ W; to lat. 37°44′04″ N, long. 122°24′05″ W; to lat. 37°44′10″ N, long. 122°23′03″ W; to lat. 37°44′10″ N, long. 122°21′53″ W; to lat. 37°44′03″ N, long. 122°20′43″ W; to lat. 37°43′52″ N, long. 122°19′49″ W; to lat. 37°43′37″ N, long. 122°18′59″ W; to lat. 37°42′40″ N, long. 122°16′43″ W; to lat. 37°40′21″ N, long. 122°14′12″ W; to lat. 37°35′32″ N, long. 122°14′06″ W; to lat. 37°33′53″ N, long. 122°14′49″ W; to lat. 37°33′00″ N, long. 122°15′24″ W; to lat. 37°33′39″ N, long. 122°16′55″ W; to lat. 37°33′38″ N, long. 122°17′48″ W; to lat. 37°32′57″ N, long. 122°20′25″ W; to lat. 37°32′54″ N, long. 122°22′20″ W; to lat. 37°33′08″ N, long. 122°22′36″ W; to lat. 37°33′36″ N, long. 122°22′58″ W; to lat. 37°33′56″ N, long. 122°23′19″ W; to lat. 37°34′01″ N, long. 122°23′34″ W; to lat. 37°34′17″ N, long. 122°23′50″ W; to lat. 37°34′29″ N, long. 122°24′01″ W; to lat. 37°35′00″ N, long. 122°24′17″ W; to lat. 37°36′09″ N, long. 122°25′36″ W; to lat. 37°36′22″ N, long. 122°25′42″ W; to lat. 37°36′42″ N, long. 122°25′34″ W; to lat. 37°38′26″ N, long. 122°29′41″ W; to lat. 37°39′25″ N, long. 122°29′41″ W; to lat. 37°40′32″ N, long. 122°29′44″ W; to lat. 37°41′08″ N, long. 122°29′46″ W, thence to the point of beginning.

    Area B. That airspace extending upward from 1,400 feet MSL to and including 10,000 feet MSL within the area bounded by a line beginning at lat. 37°35′32″ N, long. 122°14′06″ W; to lat. 37°35′11″ N, long. 122°11′13″ W; to lat. 37°32′49″ N, long. 122°12′15″ W; to lat. 37°31′29″ N, long. 122°13′08″ W; to lat. 37°33′00″ N, long. 122°15′24″ W; to lat. 37°33′53″ N, long. 122°14′49″ W, thence to the point of beginning.

    Area C. That airspace extending upward from 1,600 feet MSL to and including 10,000 feet MSL within the area bounded by a line beginning at lat. 37°41′25″ N, long. 122°30′23″ W; to lat. 37°41′08″ N, long. 122°29′46″ W; to lat. 37°40′32″ N, long. 122°29′44″ W; to lat. 37°39′25″ N, long. 122°29′41″ W; to lat. 37°40′04″ N, long. 122°31′15″ W; to lat. 37°41′25″ N, long. 122°30′23″ W, thence to the point of beginning.

    Area D. That airspace extending upward from 2,100 feet MSL to and including 10,000 feet MSL within the area bounded by a line beginning at lat. 37°44′35″ N, long. 122°35′53″ W; to lat. 37°41′40″ N, long. 122°29′11″ W; to lat. 37°41′08″ N, long. 122°29′46″ W; to lat. 37°40′32″ N, long. 122°29′44″ W; to lat. 37°39′25″ N, long. 122°29′41″ W; to lat. 37°38′42″ N, long. 122°29′41″ W; to lat. 37°38′26″ N, long. 122°29′41″ W; to lat. 37°39′19″ N, long. 122°31′44″ W; to lat. 37°41′47″ N, long. 122°37′40″ W, thence to the point of beginning.

    Area E. That airspace extending upward from 2,100 feet MSL to and including 10,000 feet MSL within the area bounded by a line beginning at lat. 37°44′15″ N, long. 122°28′11″ W; to lat. 37°47′12″ N, long. 122°18′31″ W; to lat. 37°45′33″ N, long. 122°14′38″ W; to lat. 37°44′42″ N, long. 122°15′13″ W; to lat. 37°42′17″ N, long. 122°11′39″ W; to lat. 37°39′53″ N, long. 122°11′31″ W; to lat. 37°35′11″ N, long. 122°11′13″ W; to lat. 37°35′32″ N, long. 122°14′06″ W; to lat. 37°40′21″ N, long. 122°14′12″ W; to lat. 37°42′40″ N, long. 122°16′43″ W; to lat. 37°43′37″ N, long. 122°18′59″ W; to lat. 37°43′52″ N, long. 122°19′49″ W; to lat. 37°44′03″ N, long. 122°20′43″ W; to lat. 37°44′10″ N, long. 122°21′53″ W; to lat. 37°44′10″ N, long. 122°23′03″ W; to lat. 37°44′04″ N, long. 122°24′05″ W; to lat. 37°43′52″ N, long. 122°25′04″ W; to lat. 37°43′31″ N, long. 122°26′10″ W; to lat. 37°43′08″ N, long. 122°27′05″ W; to lat. 37°42′32″ N, long. 122°28′07″ W, thence to the point of beginning.

    Area F. That airspace extending upward from 2,100 feet MSL to and including 10,000 feet MSL within the area bounded by a line beginning at lat. 37°35′11″ N, long. 122°11′13″ W; to lat. 37°34′12″ N, long. 122°08′08″ W; to lat. 37°32′01″ N, long. 122°09′06″ W; to lat. 37°29′30″ N, long. 122°08′21″ W; to lat. 37°29′02″ N, long. 122°11′17″ W; to lat. 37°30′53″ N, long. 122°14′38″ W; to lat. 37°33′38″ N, long. 122°17′48″ W; to lat. 37°33′39″ N, long. 122°16′55″ W; to lat. 37°33′00″ N, long. 122°15′24″ W; to lat. 37°31′29″ N, long. 122°13′08″ W; to lat. 37°32′49″ N, long. 122°12′15″ W, thence to the point of beginning.

    Area G. That airspace extending upward from 3,000 feet MSL to and including 10,000 feet MSL within the area bounded by a line beginning at lat. 37°50′22″ N, long. 122°41′07″ W; to lat. 37°47′11″ N, long. 122°36′40″ W; to lat. 37°51′35″ N, long. 122°29′32″ W; to lat. 37°51′03″ N, long. 122°20′24″ W; to lat. 37°47′58″ N, long. 122°13′04″ W; to lat. 37°45′33″ N, long. 122°14′38″ W; to lat. 37°47′12″ N, long. 122°18′31″ W; to lat. 37°44′15″ N, long. 122°28′11″ W; to lat. 37°42′32″ N, long. 122°28′07″ W; to lat. 37°41′40″ N, long. 122°29′11″ W; to lat. 37°44′35″ N, long. 122°35′53″ W; to lat. 37°41′47″ N, long. 122°37′40″ W; to lat. 37°39′19″ N, long. 122°31′44″ W; to lat. 37°38′26″ N, long. 122°29′41″ W; to lat. 37°36′42″ N, long. 122°25′34″ W; to lat. 37°36′22″ N, long. 122°25′42″ W; to lat. 37°36′09″ N, long. 122°25′36″ W; to lat. 37°35′00″ N, long. 122°24′17″ W; to lat. 37°34′29″ N, long. 122°24′01″ W; to lat. 37°34′17″ N, long. 122°23′50″ W; to lat. 37°40′37″ N, long. 122°39′05″ W; to lat. 37°46′40″ N, long. 122°47′13″ W, thence to the point of beginning.

    Area H. That airspace extending upward from 3,000 feet MSL to and including 10,000 feet MSL within the area bounded by a line beginning at lat. 37°39′53″ N, long. 122°11′31″ W; to lat. 37°34′50″ N, long. 122°03′58″ W; to lat. 37°30′24″ N, long. 122°05′54″ W; to lat. 37°27′10″ N, long. 122°07′39″ W; to lat. 37°26′26″ N, long. 122°10′38″ W; to lat. 37°28′39″ N, long. 122°13′10″ W; to lat. 37°32′19″ N, long. 122°21′54″ W; to lat. 37°32′54″ N, long. 122°22′20″ W; to lat. 37°32′57″ N, long. 122°20′25″ W; to lat. 37°33′38″ N, long. 122°17′48″ W; to lat. 37°30′53″ N, long. 122°14′38″ W; to lat. 37°29′02″ N, long. 122°11′17″ W; to lat. 37°29′30″ N, long. 122°08′21″ W; to lat. 37°32′01″ N, long. 122°09′06″ W; to lat. 37°34′12″ N, long. 122°08′08″ W; to lat. 37°35′11″ N, long. 122°11′13″ W, thence to the point of beginning.

    Area I. That airspace extending upward from 4,000 feet MSL to and including 10,000 feet MSL within the area bounded by a line beginning at lat. 37°55′31″ N, long. 122°23′04″ W; to lat. 37°53′11″ N, long. 122°09′28″ W; to lat. 37°41′50″ N, long. 121°57′39″ W; to lat. 37°32′33″ N, long. 121°55′58″ W; to lat. 37°28′19″ N, long. 121°57′49″ W; to lat. 37°22′19″ N, long. 122°05′04″ W; to lat. 37°20′04″ N, long. 122°07′47″ W; to lat. 37°22′58″ N, long. 122°19′36″ W; to lat. 37°29′37″ N, long. 122°27′17″ W; to lat. 37°39′32″ N, long. 122°51′17″ W; to lat. 37°44′03″ N, long. 122°51′30″ W; to lat. 37°46′40″ N, long. 122°47′13″ W; to lat. 37°40′37″ N, long. 122°39′05″ W; to lat. 37°34′17″ N, long. 122°23′50″ W; to lat. 37°34′01″ N, long. 122°23′34″ W; to lat. 37°33′56″ N, long. 122°23′19″ W; to lat. 37°33′36″ N, long. 122°22′58″ W; to lat. 37°33′08″ N, long. 122°22′36″ W; to lat. 37°32′54″ N, long. 122°22′20″ W; to lat. 37°32′19″ N, long. 122°21′54″ W; to lat. 37°28′39″ N, long. 122°13′10″ W; to lat. 37°26′26″ N, long. 122°10′38″ W; to lat. 37°27′10″ N, long. 122°07′39″ W; to lat. 37°30′24″ N, long. 122°05′54″ W; to lat. 37°34′50″ N, long. 122°03′58″ W; to lat. 37°39′53″ N, long. 122°11′31″ W; to lat. 37°42′17″ N, long. 122°11′39″ W; to lat. 37°44′42″ N, long. 122°15′13″ W; to lat. 37°45′33″ N, long. 122°14′38″ W; to lat. 37°47′58″ N, long. 122°13′04″ W; to lat. 37°51′03″ N, long. 122°20′24″ W; to lat. 37°51′35″ N, long. 122°29′32″ W, thence to the point of beginning.

    Area J. That airspace extending upward from 5,000 feet MSL to and including 10,000 feet MSL within the area bounded by a line beginning at lat. 38°00′00″ N, long. 122°25′00″ W; to lat. 37°58′50″ N, long. 122°05′45″ W; to lat. 37°53′11″ N, long. 122°09′28″ W; to lat. 37°55′31″ N, long. 122°23′04″ W; to lat. 37°51′35″ N, long. 122°29′32″ W; to lat. 37°47′11″ N, long. 122°36′40″ W; to lat. 37°50′22″ N, long. 122°41′07″ W, thence to the point of beginning.

    Area K. That airspace extending upward from 6,000 feet MSL to and including 10,000 feet MSL within the area bounded by a line beginning at lat. 37°58′50″ N, long. 122°05′45″ W; to lat. 37°54′06″ N, long. 121°59′12″ W; to lat. 37°51′17″ N, long. 121°58′51″ W; to lat. 37°53′11″ N, long. 122°09′28″ W, thence to the point of beginning.

    Area L. That airspace extending upward from 5,000 feet MSL to and including 10,000 feet MSL within the area bounded by a line beginning at lat. 37°53′11″ N, long. 122°09′28″ W; to lat. 37°51′17″ N, long. 121°58′51″ W; to lat. 37°41′50″ N, long. 121°57′39″ W, thence to the point of beginning.

    Area M. That airspace extending upward from 6,000 feet MSL to and including 10,000 feet MSL within the area bounded by a line beginning at lat. 37°39′32″ N, long. 122°51′17″ W; to lat. 37°29′37″ N, long. 122°27′17″ W; to lat. 37°22′58″ N, long. 122°19′36″ W; to lat. 37°20′04″ N, long. 122°07′47″ W; to lat. 37°22′19″ N, long. 122°05′04″ W; to lat. 37°28′19″ N, long. 121°57′49″ W; to lat. 37°32′33″ N, long. 121°55′58″ W; to lat. 37°32′27″ N, long. 121°53′05″ W; to lat. 37°32′54″ N, long. 121°51′09″ W; to lat. 37°28′25″ N, long. 121°49′25″ W; to lat. 37°24′12″ N, long. 121°55′56″ W; to lat. 37°19′04″ N, long. 122°03′49″ W; to lat. 37°10′36″ N, long. 122°00′30″ W; to lat. 37°15′08″ N, long. 122°24′54″ W; to lat. 37°15′04″ N, long. 122°24′55″ W; to lat. 37°15′03″ N, long. 122°25′01″ W; to lat. 37°14′54″ N, long. 122°25′07″ W; to lat. 37°14′39″ N, long. 122°25′00″ W; to lat. 37°14′29″ N, long. 122°25′03″ W; to lat. 37°14′01″ N, long. 122°24′53″ W; to lat. 37°13′34″ N, long. 122°24′30″ W; to lat. 37°13′18″ N, long. 122°24′26″ W; to lat. 37°13′02″ N, long. 122°24′31″ W; to lat. 37°12′01″ N, long. 122°24′30″ W; to lat. 37°11′24″ N, long. 122°23′57″ W; to lat. 37°11′10″ N, long. 122°23′54″ W; to lat. 37°11′01″ N, long. 122°23′38″ W; to lat. 37°11′03″ N, long. 122°23′27″ W; to lat. 37°10′59″ N, long. 122°22′55″ W; to lat. 37°10′45″ N, long. 122°22′39″ W; to lat. 37°10′34″ N, long. 122°22′20″ W; to lat. 37°10′25″ N, long. 122°22′09″ W; to lat. 37°10′11″ N, long. 122°21′57″ W; to lat. 37°15′22″ N, long. 122°50′17″ W, thence to the point of beginning.

    Area N. That airspace extending upward from 8,000 feet MSL to and including 10,000 feet MSL within the area bounded by a line beginning at lat. 37°10′36″ N, long. 122°00′30″ W; to lat. 37°15′08″ N, long. 122°24′54″ W; to lat. 37°15′04″ N, long. 122°24′55″ W; to lat. 37°15′03″ N, long. 122°25′01″ W; to lat. 37°14′54″ N, long. 122°25′07″ W; to lat. 37°14′39″ N, long. 122°25′00″ W; to lat. 37°14′29″ N, long. 122°25′03″ W; to lat. 37°14′01″ N, long. 122°24′53″ W; to lat. 37°13′34″ N, long. 122°24′30″ W; to lat. 37°13′18″ N, long. 122°24′26″ W; to lat. 37°13′02″ N, long. 122°24′31″ W; to lat. 37°12′01″ N, long. 122°24′30″ W; to lat. 37°11′24″ N, long. 122°23′57″ W; to lat. 37°11′10″ N, long. 122°23′54″ W; to lat. 37°11′01″ N, long. 122°23′38″ W; to lat. 37°11′03″ N, long. 122°23′27″ W; to lat. 37°10′59″ N, long. 122°22′55″ W; to lat. 37°10′45″ N, long. 122°22′39″ W; to lat. 37°10′34″ N, long. 122°22′20″ W; to lat. 37°10′25″ N, long. 122°22′09″ W; to lat. 37°10′11″ N, long. 122°21′57″ W; to lat. 37°05′50″ N, long. 121°58′38″ W, thence to the point of beginning.

    Area O. That airspace extending upward from 7,000 feet MSL to and including 10,000 feet MSL within the area bounded by a line beginning at lat. 37°54′06″ N, long. 121°59′12″ W; to lat. 37°51′25″ N, long. 121°55′58″ W; to lat. 37°42′02″ N, long. 121°51′17″ W; to lat. 37°41′50″ N, long. 121°57′39″ W; to lat. 37°51′17″ N, long. 121°58′51″ W, thence to the point of beginning.

    Area P. That airspace extending upward from 7,000 feet MSL to and including 10,000 feet MSL within the area bounded by a line beginning at lat. 37°32′54″ N, long. 121°51′09″ W; to lat. 37°33′53″ N, long. 121°46′49″ W; to lat. 37°29′10″ N, long. 121°45′04″ W; to lat. 37°26′32″ N, long. 121°45′50″ W; to lat. 37°22′31″ N, long. 121°52′05″ W; to lat. 37°24′12″ N, long. 121°55′56″ W; to lat. 37°28′25″ N, long. 121°49′25″ W, thence to the point of beginning.

    Area Q. That airspace extending upward from 8,000 feet MSL to and including 10,000 feet MSL within the area bounded by a line beginning at lat. 37°41′50″ N, long. 121°57′39″ W; to lat. 37°42′02″ N, long. 121°51′17″ W; to lat. 37°35′02″ N, long. 121°37′45″ W; to lat. 37°31′02″ N, long. 121°37′11″ W; to lat. 37°23′32″ N, long. 121°42′43″ W; to lat. 37°22′31″ N, long. 121°52′05″ W; to lat. 37°26′32″ N, long. 121°45′50″ W; to lat. 37°29′10″ N, long. 121°45′04″ W; to lat. 37°33′53″ N, long. 121°46′49″ W; to lat. 37°32′27″ N, long. 121°53′05″ W; to lat. 37°32′33″ N, long. 121°55′58″ W, thence to the point of beginning.

    Issued in Washington, DC, on January 16, 2018. Scott M. Rosenbloom, Acting Manager, Airspace Policy Group. BILLING CODE 4910-13-P EP19JA18.003
    [FR Doc. 2018-01023 Filed 1-17-18; 4:15 pm] BILLING CODE 4910-13-C
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 7 [Docket No. FDA-2016-D-3548] Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C; Draft 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 draft guidance entitled “Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C; Draft Guidance for Industry and FDA Staff.” The draft guidance, when finalized, establishes official guidance for industry and FDA staff regarding the use, content, and circumstances for issuance of public warnings and public notification of voluntary recalls under Federal regulations. The intent of the draft guidance is to increase and expedite the appropriate and accurate use of public warnings and public notification, to increase public health protection by better informing the public about violative products being recalled. The draft guidance clarifies and supplements existing policy for industry and FDA staff regarding the use of public warnings and public notification.

    DATES:

    Submit either electronic or written comments on the draft guidance by March 20, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.

    ADDRESSES:

    You may submit comments on any guidance at any time as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

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

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

    Written/Paper Submissions

    Submit written/paper submissions as follows:

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

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

    Instructions: All submissions received must include the Docket No. FDA-2016-D-3548 for “Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C; Draft Guidance for Industry and FDA 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 draft guidance to the Office of Strategic Planning and Operational Policy, Office of Regulatory Affairs, Food and Drug Administration, 12420 Parklawn Dr., Element Building, Rockville, MD 20857. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

    FOR FURTHER INFORMATION CONTACT:

    Chris Henderson, Office of Regulatory Affairs, Food and Drug Administration, 12420 Parklawn Dr., Rockville, MD 20857, 240-402-8186, [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Background

    FDA is announcing the availability of a draft guidance for industry and FDA staff entitled “Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C.” The draft guidance, when finalized, will establish official guidance for industry and FDA staff regarding the use, content, and timing of public warnings and public notification of recalls under part 7 (21 CFR part 7). The draft guidance is part of a larger effort FDA is undertaking to give additional guidance to industry and FDA staff regarding the execution and oversight of voluntary recalls under part 7.

    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 public warnings and notification of recalls. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This draft guidance is not subject to Executive Order 12866.

    II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). Any collection of information, including a firm's public warning (§ 7.42(b)(2)), has been approved under OMB control number 0910-0249.

    III. Electronic Access

    Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/Safety/Recalls/default.htm or https://www.regulations.gov.

    Dated: January 16, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-00918 Filed 1-18-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF COMMERCE United States Patent and Trademark Office 37 CFR Parts 1 and 42 [Docket No.: PTO-P-2017-0034] RIN 0651-AD25 Changes To Eliminate Unnecessary Regulations AGENCY:

    United States Patent and Trademark Office, Commerce.

    ACTION:

    Notice of proposed rulemaking.

    SUMMARY:

    The United States Patent and Trademark Office (USPTO or Office) proposes to remove its regulations governing reservation clauses, petitions from the refusal of a primary examiner to admit an amendment, the publication of amendments to the regulations, and limits that the Director can impose on the number of inter partes reviews and post-grant reviews heard by the Patent Trial and Appeal Board. These regulations are unnecessary or superfluous and in some cases have expired, and their removal will help streamline USPTO's body of regulations without reducing the availability of services for the public. This proposed rule arises out of the USPTO's work during FY 2017 to identify and propose regulations for removal, modification, and streamlining because they are outdated, unnecessary, ineffective, costly, or unduly burdensome on the agency or the private sector. The revisions proposed herein would put into effect the work the USPTO has done, in part through its participation in the Regulatory Reform Task Force established by the Department of Commerce pursuant to Executive Order 13777, to review and identify regulations that are candidates for removal.

    DATES:

    Written comments must be received on or before February 20, 2018.

    ADDRESSES:

    Comments on the changes set forth in this proposed rulemaking should be sent by electronic mail message to: [email protected] Comments may also be submitted by postal mail addressed to: Mail Stop Comments—Patents, Commissioner for Patents, P.O. Box 1450, Alexandria, VA, 22313-1450, marked to the attention of Raul Tamayo, Senior Legal Advisor, Office of Patent Legal Administration. Comments concerning ideas to improve, revise, and streamline other USPTO regulations, not discussed in this proposed rulemaking, should be submitted to: [email protected]

    Comments may also be submitted via the Federal eRulemaking Portal at http://www.regulations.gov. See the Federal eRulemaking Portal website for additional instructions on providing comments via the Federal eRulemaking Portal. Although comments may be submitted by postal mail, the Office prefers to receive comments by electronic mail message over the internet because the Office may easily share such comments with the public. Electronic comments are preferred to be submitted in plain text, but also may be submitted in ADOBE® portable document format or MICROSOFT WORD® format. Comments not submitted electronically should be submitted on paper in a format that facilitates convenient digital scanning into ADOBE® portable document format.

    The comments will be available for public inspection at the Office of the Commissioner for Patents, currently located in Madison East, 600 Dulany Street, Alexandria, Virginia. Comments also will be available for viewing via the Office's internet website (http://www.uspto.gov) and at http://www.regulations.gov. Because comments will be made available for public inspection, information that the submitter does not desire to make public, such as an address or phone number, should not be included in the comments.

    FOR FURTHER INFORMATION CONTACT:

    Raul Tamayo, Senior Legal Advisor, Office of Patent Legal Administration, at (571) 272-7728, for questions regarding the changes to 37 CFR 1.79 and/or 1.127; Susan L. C. Mitchell, Lead Administrative Patent Judge, Patent Trial and Appeal Board, at (571) 272-8715, for questions regarding the changes to 37 CFR part 42; and Nicolas Oettinger, Senior Counsel for Regulatory and Legislative Affairs, Office of the General Counsel, at (571) 272-7832, for questions regarding the change to 37 CFR 1.351 and general questions regarding regulatory reform.

    SUPPLEMENTARY INFORMATION:

    I. Background

    In accordance with Executive Order 13777, “Enforcing the Regulatory Reform Agenda,” the Department of Commerce established a Regulatory Reform Task Force (Task Force), comprising, among others, agency officials from the National Oceanic and Atmospheric Administration, the Bureau of Industry and Security, and the USPTO, and charged the Task Force with evaluating existing regulations and identifying those that should be repealed, replaced, or modified because they are potentially outdated, unnecessary, ineffective, costly, or unduly burdensome to both government and private sector operations.

    To support its regulatory reform efforts on the Task Force, the USPTO assembled a Working Group on Regulatory Reform (Working Group), consisting of subject matter experts from each of the business units that implement the USPTO's regulations, to consider, review, and recommend ways that the regulations could be improved, revised, and streamlined. In considering the revisions, the USPTO, through its Working Group, incorporated into its analyses all presidential directives relating to regulatory reform. The Working Group reviewed existing regulations, both discretionary and required by statute or judicial order. The USPTO also solicited comments from stakeholders through a web page established to provide information on the USPTO's regulatory reform efforts, and through the Department's Federal Register Notice titled “Impact of Federal Regulations on Domestic Manufacturing” (82 FR 12786, Mar. 7, 2017), which addressed the impact of regulatory burdens on domestic manufacturing. These efforts led to the development of candidate regulations for removal based on the USPTO's assessment that these regulations were not needed and/or that elimination could improve the USPTO's body of regulations. To facilitate review and public comment, the USPTO consolidates and proposes in this rule revisions to patent regulations in Part 1 and Patent Trial and Appeal Board regulations in Part 42. Other proposals to remove regulations on other subject areas may be published separately.

    II. Regulations Proposed for Removal

    This proposed rulemaking would remove regulations concerning reservation clauses, petitions from the refusal of a primary examiner to admit an amendment, and publication of amendments to the regulations in 37 CFR part 1. This proposed rulemaking would also remove regulations concerning limits that the Director can impose on the number of inter partes reviews and post-grant reviews in 37 CFR part 42.

    In particular, this proposed rulemaking would remove 37 CFR 1.79. Section 1.79 prohibits reservation clauses, i.e., it prohibits a pending patent application from containing a reservation for a future patent application of subject matter disclosed but not claimed in the pending application. An applicant's ability to claim benefit of a prior application is affirmatively provided elsewhere in statute and regulation (as described below), and the explicit prohibition of § 1.79 on reservation clauses (which do not confer this benefit) dates from a time when the mechanism for properly claiming benefit of a prior application was less clear and less fully developed in USPTO's regulations and guidance. The proposed removal of § 1.79 is not an endorsement of reservation clauses nor an invitation for applicants to include reservation clauses in applications. The Office does not expect the use of reservation clauses to significantly increase once the proposed rulemaking is made final, because such reservation clauses provide no legal benefit, regardless of § 1.79. For example, the inclusion of a reservation clause in a pending application would not change any of the requirements for a future application to benefit from the earlier filing date of the pending application. The authority for the future application to benefit from the earlier filing date of the pending application would stem, as it does now, from the fulfillment of requirements set forth in statutory and regulatory provisions in which a reservation clause plays no role, e.g., 35 U.S.C. 120 and 37 CFR 1.78. Nor would the inclusion of a reservation clause protect against rejections for statutory or nonstatutory double patenting. In view of the fact that the inclusion of a reservation clause provides no legal benefit, and given that the affirmative ability to claim benefit of a prior application is more fully and completely described elsewhere in USPTO's regulations and guidance (unlike when § 1.79 was first adopted), the prohibition of reservation clauses in § 1.79 is unnecessary.

    Section 1.79 also permits a patent application disclosing unclaimed subject matter to contain a reference to a later filed application of the same applicant or owned by a common assignee disclosing and claiming that subject matter. This provision of § 1.79 is duplicative and therefore unnecessary. 37 CFR 1.78 provides for cross-references to other applications, including cross-references to applications for which a benefit is not claimed, which encompasses the later filed applications identified in § 1.79. Thus, once the proposed rulemaking is made final, applicants will continue to be able to include in a pending application a reference to a later filed application as currently provided for in § 1.79.

    This proposed rulemaking would remove § 1.127, which also is duplicative. Section 1.127 indicates that a petition to the Director under 37 CFR 1.181 may be filed upon a refusal by a primary examiner to admit an amendment, in whole or in part. Section 1.127 is unnecessary. The language of § 1.181 makes clear that a refusal by a primary examiner to admit an amendment is petitionable under § 1.181. The Manual of Patent Examining Procedure (9th ed. 2014) (Rev. Nov. 2015) also makes this fact clear in its discussion at section 1002.02(c). Thus, once the proposed rulemaking is made final, applicants will continue to be able to petition under § 1.181 the refusal by a primary examiner to admit an amendment, in whole or in part.

    This proposed rulemaking additionally would remove 37 CFR 1.351. Section 1.351 states that all amendments to the regulations in 37 CFR part 1 will be published in the Official Gazette and in the Federal Register. Section 1.351 is unnecessary. In accordance with the requirements of the Administrative Procedure Act (APA) and guidance from the Office of Management and Budget (OMB), the Office publishes any amendments to 37 CFR part 1 in the Federal Register. The APA generally requires the Office to give public notice of any regulatory change, and OMB's guidance with respect to rulemaking makes clear that publication in the Federal Register is the required means for giving public notice. Furthermore, the Office intends to continue publishing all amendments to the regulations in 37 CFR part 1 in the Official Gazette. Thus, once the proposed rulemaking is made final, the Office will continue the practice of publishing all amendments to the regulations in 37 CFR part 1 in the Federal Register, as required by OMB, and in the Official Gazette.

    Finally, this proposed rulemaking would remove 37 CFR 42.102(b) and 42.202(b), both of which are now out of date. Section 42.102(b) provides that the Director may impose a limit on the number of inter partes reviews that may be instituted during each of the first four one-year periods that the Leahy-Smith America Invents Act (AIA) is in effect. Section 42.202(b) has a similar provision for post-grant reviews. Neither rule remains necessary because the fourth anniversary of the effective date of the AIA has passed.

    The regulations proposed in this rule for removal achieve the objective of making the USPTO's regulations more streamlined and less burdensome, while enabling the USPTO to fulfill its mission goals. The USPTO's analysis shows that removal of these regulations is not expected to substantially reduce the burden on the impacted community; however, the regulations are nonetheless being eliminated because they are “outdated, unnecessary, or ineffective” regulations encompassed by the directives in Executive Order 13777.

    III. Discussion of Proposed Rules Changes Part 1

    Section 1.79: Section 1.79 is removed and reserved.

    Section 1.127: Section 1.127 is removed and reserved.

    Section 1.351: Section 1.351 is removed and reserved.

    Part 42

    Section 42.102(b): Section 42.102(b) is removed and reserved.

    Section 42.202(b): Section 42.202(b) is removed and reserved.

    Rulemaking Considerations

    A. Administrative Procedure Act: The changes in this proposed rulemaking involve rules of agency practice and procedure, and/or interpretive rules. See Perez v. Mortg. Bankers Ass'n, 135 S. Ct. 1199, 1204 (2015) (Interpretive rules “advise the public of the agency's construction of the statutes and rules which it administers.” (citation and internal quotation marks omitted)); Nat'l Org. of Veterans' Advocates v. Sec'y of Veterans Affairs, 260 F.3d 1365, 1375 (Fed. Cir. 2001) (Rule that clarifies interpretation of a statute is interpretive.); Bachow Commc'ns Inc. v. FCC, 237 F.3d 683, 690 (D.C. Cir. 2001) (Rules governing an application process are procedural under the Administrative Procedure Act.); Inova Alexandria Hosp. v. Shalala, 244 F.3d 342, 350 (4th Cir. 2001) (Rules for handling appeals were procedural where they did not change the substantive standard for reviewing claims.).

    Accordingly, prior notice and opportunity for public comment for the changes in this proposed rulemaking are not required pursuant to 5 U.S.C. 553(b) or (c), or any other law. See Perez, 135 S. Ct. at 1206 (Notice-and-comment procedures are required neither when an agency “issue[s] an initial interpretive rule” nor “when it amends or repeals that interpretive rule.”); Cooper Techs. Co. v. Dudas, 536 F.3d 1330, 1336-37 (Fed. Cir. 2008) (stating that 5 U.S.C. 553, and thus 35 U.S.C. 2(b)(2)(B), does not require notice and comment rulemaking for “interpretative rules, general statements of policy, or rules of agency organization, procedure, or practice” (quoting 5 U.S.C. 553(b)(A))). The Office, however, is publishing these proposed changes for comment as it seeks the benefit of the public's views on the Office's proposed implementation of the proposed rule changes.

    B. Regulatory Flexibility Act: For the reasons set forth herein, Senior Counsel for Regulatory and Legislative Affairs, Office of General Law, of the USPTO, has certified to the Chief Counsel for Advocacy of the Small Business Administration that changes proposed in this notice will not have a significant economic impact on a substantial number of small entities. See 5 U.S.C. 605(b).

    This proposed rule would remove the provisions at 37 CFR 1.79, concerning the prohibition of reservation clauses, § 1.127, concerning petitions from refusal to admit amendment, and § 1.351, concerning the publication of amendments to rules. These regulations are removed because they are not necessary. This rule would also remove 37 CFR 42.102(b) and 42.202(b), which provide that the Director may impose a limit on the number of inter partes reviews and post-grant reviews that may be instituted during each of the first four one-year periods that the AIA is in effect. These regulations are no longer necessary because the fourth anniversary of the effective date of the AIA has passed.

    Removing these regulations achieves the objective of making the USPTO's regulations more effective and more streamlined, while enabling the USPTO to fulfill its mission goals. The removal of these regulations is not expected to substantively impact parties as parties would either continue to be able to take the same action under a different regulatory provision, or the rights or obligations of the parties would not be changed in any way. For these reasons, this rulemaking will not have a significant economic impact on a substantial number of small entities.

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

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

    E. Executive Order 13771 (Reducing Regulation and Controlling Regulatory Costs): This proposed rule is expected to be an Executive Order 13771 deregulatory action.

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

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

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

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

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

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

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

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

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

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

    P. Paperwork Reduction Act: The Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.) requires that the Office consider the impact of paperwork and other information collection burdens imposed on the public. This rulemaking does not involve an information collection that is subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3549).

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

    List of Subjects 37 CFR Part 1

    Administrative practice and procedure, Courts, Freedom of Information, Inventions and patents, Reporting and recordkeeping requirements, Small businesses.

    37 CFR Part 42

    Administrative practice and procedure, Inventions and patents.

    For the reasons stated in the preamble, the Office proposes to amend parts 1 and 42 of title 37 as follows:

    PART 1—RULES OF PRACTICE IN PATENT CASES 1. The authority citation for part 1 continues to read as follows: Authority:

    35 U.S.C. 2(b)(2).

    § 1.79 [Removed and reserved]
    2. Section 1.79 is removed and reserved.
    § 1.127 [Removed and reserved]
    3. Section 1.127 is removed and reserved.
    § 1.351 [Removed and reserved]
    4. Section 1.351 is removed and reserved. PART 42—TRIAL PRACTICE BEFORE THE PATENT TRIAL AND APPEAL BOARD 5. The authority citation for part 42 continues to read as follows: Authority:

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

    § 42.102 [Amended]
    6. Amend § 42.102 by removing and reserving paragraph (b).
    § 42.202 [Amended]
    7. Amend § 42.202 by removing and reserving paragraph (b). Dated: January 11, 2018. Joseph Matal, Associate Solicitor, performing the functions and duties of the Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office.
    [FR Doc. 2018-00769 Filed 1-18-18; 8:45 am] BILLING CODE 3510-16-P
    DEPARTMENT OF VETERANS AFFAIRS 38 CFR Part 1 RIN 2900-AP90 Consent for Release of VA Medical Records AGENCY:

    Department of Veterans Affairs.

    ACTION:

    Proposed rule.

    SUMMARY:

    The Department of Veterans Affairs (VA) proposes to amend its regulations to clarify that a valid consent authorizing the Department to release the patient's confidential VA medical records to a health information exchange (HIE) community partner may be established not only by VA's physical possession of the written consent form, but also by the HIE community partner's written (electronic) attestation that the patient has, in fact, provided such consent. This proposed rule would be a reinterpretation of an existing, long-standing regulation and is necessary to facilitate modern requirements for the sharing of patient records with community health care providers, health plans, governmental agencies, and other entities participating in electronic HIEs. This revision would ensure that more community health care providers and other HIE community partners can deliver informed medical care to patients by having access to the patient's VA medical records at the point of care.

    DATES:

    Comment Date: Comments must be received on or before March 20, 2018.

    ADDRESSES:

    Written comments may be submitted through www.Regulations.gov; by mail or hand-delivery to Director, Regulation Policy and Management (00REG), Department of Veterans Affairs, 810 Vermont Avenue NW, Room 1063B, Washington, DC 20420; or by fax to (202) 273-9026. Comments should indicate that they are submitted in response to “RIN 2900-AP90 Consent for Release of VA Medical Records.” Copies of comments received will be available for public inspection in the Office of Regulation Policy and Management, Room 1063B, between the hours of 8:00 a.m. and 4:30 p.m., Monday through Friday (except holidays). Please call (202) 461-4902 for an appointment. (This is not a toll-free number.) In addition, during the comment period, comments may be viewed online through the Federal Docket Management System (FDMS) at www.Regulations.gov.

    FOR FURTHER INFORMATION CONTACT:

    Stephania Griffin, Director, Veterans Health Administration Information Access and Privacy Office, Department of Veterans Affairs, 810 Vermont Avenue NW, Washington, DC 20420; [email protected], (704) 245-2492 (This is not a toll-free number.)

    SUPPLEMENTARY INFORMATION:

    Under 38 U.S.C. 7332, VA must keep confidential all records of identity, diagnosis, prognosis, or treatment of a patient in connection with any program or activity carried out by VA related to drug abuse, alcoholism or alcohol abuse, infection with human immunodeficiency virus, or sickle cell anemia, and must obtain patients' written consent before VA may disclose the protected information unless authorized by the statute. This requirement applies to communications between VA and community health care providers for the purposes of treatment, except in certain situations, for instance in medical emergencies and when the records are sent to a non-Department entity that provides hospital care to patients as authorized by the Secretary. 38 U.S.C. 7332(b)(2)(A) and (H); Public Law 115-26 (April 19, 2017). Although section 7332 does not explicitly require that the written consent physically be in VA's possession at the time of the disclosure, VA had interpreted the statute to require such possession, and therefore applied 38 CFR 1.475 consistent with that interpretation. VA has reexamined that statutory interpretation in light of contemporary healthcare industry standards and proposes to revise § 1.475 to reflect this updated reading of section 7332. This proposed rule would revise 38 CFR 1.475 to permit VA to release section 7332-protected medical records to eligible community partners, even if VA does not physically have the patient's written consent, provided that specified criteria are met.

    The ability to quickly release section 7332-protected information has become increasingly important as VA strives to support veterans' choice to seek care in the community and create innovative ways to provide effective and timely care to veterans. In this regard, VA has entered into an agreement to participate in an HIE to help facilitate the transfer of information between different organizations. An HIE is the electronic transfer of health information among organizations according to nationally recognized standards. The organizations that participate (HIE community partners) range from community health care providers and health plans to governmental agencies providing benefits, such as the Social Security Administration (SSA).

    The interpretation that valid consent may be established only by VA's physical possession of the written consent has left many HIE community partners unable to access veterans' VA medical records at the point of care. While an estimated three out of four veterans enrolled in VA's health care system also seek medical care in the community, HIE community partners' requests for their VA health records must frequently be denied because VA does not have a consent on file, and many HIE community partners therefore either must delay care to veterans or provide treatment to veterans without having the benefit of reviewing the veteran's full medical history.

    The reason for the low rate of consent is not because veterans object to providing consent; veteran participation is almost always favorable when asked to provide consent. The primary obstacle is that veterans will often seek care in the community prior to having the opportunity to provide the consent form to VA and are then left without any means of getting the consent into VA's physical possession promptly once they are at the community health care facility.

    By allowing HIE community partners to attest that they have, in fact, obtained a valid consent, VA would be able to collect consent in a broader array of circumstances. Most importantly, this would allow VA to release a veteran's medical records to an HIE community partner, such as a community health care provider or SSA, once the partner attests that they have collected valid consent, without VA having to wait for the document to be furnished. This would allow for HIE community partners to provide veterans with the most informed care, would allow VA to more expediently provide veterans' records for the adjudication of their SSA disability claims, and would also allow for VA to continue innovating and creating new ways for veterans to receive timely and high quality health care.

    VA believes that this new interpretation of section 7332—to permit disclosure to an HIE community partner pursuant to the partner's attestation regarding written consent, would uphold veterans' right to privacy. As explained in greater detail below, such disclosure would still require a legally sufficient written consent. We clarify that the only change would be that a valid consent authorizing disclosure may be established not only by VA's physical possession of the written consent form but also by the HIE community partner's attestation that the veteran has submitted legally sufficient consent. Moreover, in the private sector under the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule, health care providers are able to release a patient's confidential medical records to another one of the patient's treating providers without written consent. Therefore, VA's privacy protections would remain more robust than those of the private sector generally and greater than those required by the HIPAA Privacy Rule.

    This proposed rule would revise 38 CFR 1.460 to include definitions for “health information exchange” and “health information exchange community partner” as described above. Further, the rule would revise 1.475 as follows. Current paragraph (d) would be redesignated as paragraph (e) and would be revised as explained below. New paragraph (d) would provide the criteria to establish written consent that would authorize the disclosure of confidential VA medical records. Specifically, it would establish that, in addition to physical possession of a patient's written consent, VA may release the patient's protected medical information to an HIE community partner pursuant to that partner's attestation that valid consent has been obtained. To clarify, this paragraph would not require VA to provide the records to HIE community partners just because the partner submitted an attestation; instead, VA would have the discretion to send the records.

    Proposed paragraph (d)(1) states that written consent may be established by VA's physical possession of the patient's written consent that meets the criteria in paragraph (a) of this section. This is how VA traditionally collected consent forms.

    Paragraph (d)(2) would provide an alternative for disclosure of section 7332-protected information. VA would also be able to disclose the protected information to an HIE community partner as long as two criteria are met. Initially, we note that this alternative for disclosure would be limited to VA's partners in the HIE because the partners have all signed an agreement to comply with certain standards of practice. Additionally, all partners would be required to have the technological capabilities to provide the requisite attestation.

    The first proposed criterion is that the HIE community partner must provide written attestation that the patient has submitted legally sufficient consent to them. This requirement is necessary because 38 U.S.C. 7332 and 38 CFR 1.475 still require the veteran provide legally sufficient written consent to release section 7332-protected information. Therefore, in order for VA to release the records to the HIE community partner, VA must have an attestation or some documentation that the patient provided legally sufficient written consent.

    To clarify, “written attestation” would not require a physical document and a wet signature; electronic attestations satisfy this requirement and are the expected form of attestation from the HIE community partner. VA would not specifically require the attestation to be electronic in order to provide for flexibility if there are changes in technology and best practices. However, VA envisions the vast majority, if not all, of the attestations would be electronic through approved messaging with the HIE community partners. This proposed rule would allow for VA's community partners to electronically attest, through the computer software, that the veteran submitted legally sufficient written consent. At that time, VA would be able to release the veteran's medical records electronically to the HIE community partner.

    In addition to the written attestation, paragraph (d)(2) would require that VA have the ability to retrieve or obtain the written consent. There are two ways in which VA can obtain the records. First, proposed paragraph (d)(2)(i) provides that a .HIE community partner can make the consent form available to VA within 10 business days of its attestation. This can be accomplished either by storing the written consent form electronically for access by VA or by sending the written consent form to VA.

    Second, paragraph (d)(2)(ii) would provide that the HIE community partner can maintain the patient's written consent form in accordance with a memorandum of understanding (MOU) that is drafted and signed by VA and the HIE community partner. The MOU would ensure that the patient's records are retained in accordance with VA record retention requirements set forth in VHA Records Control Schedule (RCS) 10-1. Even though VA would not require the written consent to be physically in VA's possession since it is a VA record, the HIE would have to retain the consent form according to VA's record retention requirements. Paragraph (d)(2)(ii) would also require that the MOU outline how VA can request the consent form from the HIE community partner and how the HIE community partner can make the consent form available to VA. In this regard, VA and the partner would determine a mutually agreeable timeframe to comply with a request by VA for a copy of the consent form.

    As explained above current paragraph (d) would be redesignated as new paragraph (e). This paragraph would be revised to update the name of VA Form 10-5345. Specifically, current paragraph (d) provides that it was not necessary to use any particular form to establish a consent referred to in paragraph (a) of this section, however, VA Form 10-5345, titled Request for and Consent to Release of Medical Records Protected by 38 U.S.C. 7332, may be used for such purpose. VA Form 10-5345 has been updated and renamed Request for and Authorization to Release Medical Records or Health Information. Accordingly, VA would revise the paragraph to reflect the new name of VA Form 10-5345.

    Effect of Rulemaking

    The Code of Federal Regulations, as proposed to be revised by this proposed rulemaking, would represent the exclusive legal authority on this subject. No contrary rules or procedures would be authorized. All VA guidance would be read to conform with this proposed rulemaking if possible or, if not possible, such guidance would be superseded by this rulemaking.

    Paperwork Reduction Act

    This proposed rule contains no provisions constituting a collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521).

    Regulatory Flexibility Act

    The Secretary hereby certifies that this proposed rule would 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). The overall impact of the proposed rule on small entities would be minimal as the proposed rule would only require that entities attest that they received the veteran's consent and make the written consent available to VA. These administrative burdens are similar to current burdens related to medical privacy and will not have a significant economic impact on these entities. On this basis, the Secretary certifies that the adoption of this proposed rule would 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. Therefore, under 5 U.S.C. 605(b), this rulemaking is exempt from the initial and final regulatory flexibility analysis requirements of sections 603 and 604.

    Executive Orders 12866, 13563 and 13771

    Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits of reducing costs, of harmonizing rules, and of promoting flexibility. E.O. 12866, Regulatory Planning and Review, defines “significant regulatory action” to mean 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 it has been determined not to be a significant regulatory action under E.O. 12866. This proposed rule is not expected to be an E.O. 13771 regulatory action because this proposed rule is not significant under E.O. 12866.

    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 proposed rule would 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 numbers and titles for the programs affected by this document are 64.008—Veterans Domiciliary Care; 64.011—Veterans Dental Care; 64.012—Veterans Prescription Service; 64.013—Veterans Prosthetic Appliances; 64.014—Veterans State Domiciliary Care; 64.015—Veterans State Nursing Home Care; 64.024—VA Homeless Providers Grant and Per Diem Program; 64.026—Veterans State Adult Day Health Care; 64.029—Purchase Care Program; 64.033—VA Supportive Services for Veteran Families Program; 64.039—CHAMPVA; 64.040—VHA Inpatient Medicine; 64.041—VHA Outpatient Specialty Care; 64.042—VHA Inpatient Surgery; 64.043—VHA Mental Health Residential; 64.044—VHA Home Care; 64.045—VHA Outpatient Ancillary Services; 64.046—VHA Inpatient Psychiatry; 64.047—VHA Primary Care; 64.048—VHA Mental Health clinics; 64.049—VHA Community Living Center; 64.050—VHA Diagnostic Care; 64.054—Research and Development.

    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 December 8, 2017, for publication.

    List of Subjects in 38 CFR Part 1

    Administrative practice and procedure, Archives and records, Cemeteries, Claims, Courts, Crime, Flags, Freedom of information, Government contracts, Government employees, Government property, Infants and children, Inventions and patents, Parking, Penalties, Privacy, Reporting and recordkeeping requirements, Seals and insignia, Security measures, Wages.

    Dated: January 12, 2018. Janet Coleman, Chief, Office of Regulation Policy & Management, Office of the Secretary, Department of Veterans Affairs.

    For the reasons set out in the preamble, Department of Veterans Affairs proposes to amend 38 CFR part 1 as follows:

    PART 1—GENERAL PROVISIONS 1. The authority citation for part 1 continues to read as follows: Authority:

    38 U.S.C. 501, and as noted in specific sections.

    2. Amend § 1.460 by adding, in alphabetical order, definitions for “health information exchange” and “health information exchange community partner.”
    § 1.460 Definitions.

    Health information exchange. The term “health information exchange” means the electronic transfer of health information among health care professionals, health plans, governmental agencies providing benefits, and other persons and entities according to nationally recognized standards that allow the participants to appropriately access and securely share patients' vital medical information to improve the quality, safety, and efficiency of health care delivery.

    Health information exchange community partner. The term “health information exchange community partner” means a health care provider, health plan, governmental agency providing benefits, or other person or entity with whom VA shares patients' vital medical information according to nationally recognized standards.

    3. Amend § 1.475 by redesignating paragraph (d) as paragraph (e), adding a new paragraph (d) and revising newly redesignated paragraph (e) to read as follows:
    § 1.475 Form of written consent.

    (d) Establishing written consent. A written consent authorizing the disclosure may be demonstrated by:

    (1) A written consent meeting the criteria set forth in paragraph (a) of this section that is presented to VA in physical form; or

    (2) A written attestation by a health information exchange community partner that the patient submitted legally sufficient consent meeting the criteria set forth in paragraph (a), provided that:

    (i) Within 10 business days of the health information exchange community partner's attestation, the partner either makes the written consent form available for electronic retrieval by VA or produces the written consent form to VA; or

    (ii) The health information exchange community partner complies with a memorandum of understanding signed by the partner and VA that outlines:

    (A) How the written consent will be retained in accordance with VHA Records Control Schedule (RCS) 10-1;

    (B) How VA can request the consent form from the partner; and

    (C) How the partner can send the consent form to VA.

    (e) Required Form. It is not necessary to use any particular form to establish a consent referred to in paragraph (a) of this section, however, VA Form 10-5345, titled Request for and Authorization to Release Medical Records or Health Information, complies with all applicable legal requirements and may be used for such purpose.

    [FR Doc. 2018-00758 Filed 1-18-18; 8:45 am] BILLING CODE 8320-01-P
    DEPARTMENT OF TRANSPORTATION Federal Motor Carrier Safety Administration 49 CFR Part 395 [Docket No. FMCSA-2017-0360] Hours of Service of Drivers of Commercial Motor Vehicles; Proposed Regulatory Guidance Concerning the Transportation of Agricultural Commodities; Extension of Comment Period AGENCY:

    Federal Motor Carrier Safety Administration (FMCSA), DOT

    ACTION:

    Proposed regulatory guidance; extension of comment period.

    SUMMARY:

    FMCSA extends the public comment period for the Agency's December 20, 2017, notice announcing the proposed regulatory guidance concerning the transportation of agricultural commodities. On December 22, 2017, the American Trucking Associations, Inc. (ATA) requested a 30-day extension of the comment period. Additional requests for extension of the comment period have been received. The Agency extends the January 19, 2018, deadline for the submission of public comments to February 20, 2018.

    DATES:

    FMCSA extends the comment period for the notice of proposed regulatory guidance published on December 20, 2017 at 82 FR 60360. You must submit comments on or before February 20, 2018.

    ADDRESSES:

    You may insert comments identified by Federal Docket Management System Number FMCSA-2017-0360 by any of the following methods:

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

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

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

    Fax: (202) 493-2251.

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

    FOR FURTHER INFORMATION CONTACT:

    Mr. Thomas Yager, Chief, Driver and Carrier Operations Division, Federal Motor Carrier Safety Administration, U.S. Department of Transportation, 1200 New Jersey Avenue SE, Washington, DC 20590, phone (614) 942-6477, email [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Public Participation and Request for Comments A. Submitting Comments

    If you submit a comment, please include the docket number listed above, indicate the specific section of this document to which your comment applies, and provide a reason for each suggestion or recommendation. You may submit your comments and material online or by fax, mail, or hand delivery. FMCSA recommends that you include your name and a mailing address, an email address, or a phone number in the body of your document so that FMCSA can contact you if there are questions regarding your submission.

    To submit your comment online, go to http://www.regulations.gov, put the docket number, FMCSA-2017-0360, in the keyword box, and click “Search.” When the new screen appears, click on the “Comment Now!” button and type your comment into the text box on the following screen. Choose whether you are submitting your comment as an individual or on behalf of a third party and then submit.

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

    FMCSA will consider all comments and material received during the comment period and may change this guidance based on your comments.

    B. Viewing Comments and Documents

    To view comments, go to http://www.regulations.gov. Insert the docket number, FMCSA-2017-0360, in the keyword box, and click “Search.” Next, click the “Open Docket Folder” button and choose the document to review. If you do not have access to the internet, you may view the docket online by visiting the Docket Management Facility in Room W12-140 on the ground floor of the DOT West Building, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m., e.t., Monday through Friday, except Federal holidays.

    C. Privacy Act

    In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its regulatory process. DOT posts these comments, without edit, including any personal information the commenter provides, to www.regulations.gov, as described in the system of records notice (DOT/ALL-14 FDMS), which can be reviewed at www.transportation.gov/privacy.

    II. Background

    On December 20, 2017 (82 FR 60360), FMCSA published a notice of proposed regulatory guidance concerning the transportation of agricultural commodities. That proposed guidance provides clarity to the agricultural exception in 49 CFR 395.1(k)(1) and specifically addresses two scenarios: (1) Driving an unladen commercial motor vehicle to either pick up an agricultural community or on a return trip following the delivery of an agricultural commodity; and (2) application of the agricultural commodity exemption to trips involving transportation of the commodity more than 150 air-miles from its source. In addition, the Agency requested comment on scenarios where a trip involves the loading of agricultural commodities at multiple sources and the meaning of the term “source” in connection with the loading of certain commodities. Finally, the Agency requested comment on what segments of the industry that would take advantage of the proposed change, how would the flexibility provided impact the need for electronic logging devices, and what is the population of carriers and drivers transporting various categories of agricultural commodities.

    In the December 20, 2017, notice the Agency proposed new regulatory guidance question and answer numbers 34 and 35 to 49 CFR 395.1. A copy of the proposed regulatory guidance is available for review in the docket referenced at the beginning of this notice.

    Requests for Extension of the Comment Period

    On December 22, 2017, the American Trucking Associations, Inc. (ATA), asked that the Agency provide a 30-day extension of the comment period. ATA expressed concern that end-of-year tasks and holiday periods might make it difficult for many interested parties to prepare comments by the original January 19 deadline. A copy of the ATA request is in the docket identified at the beginning of this notice. Similar requests were subsequently submitted by other organizations.

    FMCSA acknowledges the concerns of ATA and others. After reviewing the requests, FMCSA hereby grants a 30-day extension of the comment period to February 20, 2018, to provide all interested parties additional time to respond to the notice of proposed regulatory guidance.

    Issued on: January 12, 2018. Larry W. Minor, Associate Administrator for Policy.
    [FR Doc. 2018-00847 Filed 1-18-18; 8:45 am] BILLING CODE 4910-EX-P
    83 13 Friday, January 19, 2018 Notices DEPARTMENT OF AGRICULTURE Submission for OMB Review; Comment Request January 16, 2018.

    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 February 20, 2018 will be considered. Written comments should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), New Executive Office Building, 725 17th Street NW, Washington, DC 20502. Commenters are encouraged to submit their comments to OMB via email to: [email protected] or fax (202) 395-5806 and to Departmental Clearance Office, USDA, OCIO, Mail Stop 7602, Washington, DC 20250-7602. Copies of the submission(s) may be obtained by calling (202) 720-8958.

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

    Animal and Plant Health Inspection Service

    Title: Importation of Plants for Planting; Establishing a Category for Plants for Planting Not Authorized for Importation Pending Pest Risk Analysis.

    OMB Control Number: 0579-0380.

    Summary of Collection: Under the Plant Protection Act (7 U.S.C. 7701—et seq.), the Secretary of Agriculture is authorized to take such actions as may be necessary to prevent the introduction and spread of plant pests and noxious weeds within the United States. The United States Department of Agriculture, Animal and Plant Health Inspection Service (APHIS) regulations establish categories of regulated articles governing the importation of nursery stock, also known as plants for planting. This category lists taxa for plants for planting whose importation is not authorized pending pest risk analysis. Requests to remove a taxa from the category of plants for planting whose impact is not authorized pending the completion of a pest risk analysis must be made in accordance with § 319.5.

    Need and Use of the Information: APHIS will collect the following information as part of the request before a Pest Risk Assessment can be prepared: (1) A description and/or map of the specific locations(s) of the areas in the exporting country where the plant, plant parts, or plant products are produced; (2) Scientific name (including genus, species, and author names) and taxonomic classification of arthropods, fungi, bacteria, nematodes, viruses, viroids, mollusks, phytoplasmas, spiroplasmas, etc., attacking the crop; and (3) Plant part attacked by each pest, pest life stages associated with plant part attacked, and location of pest (in, on, or with commodity).

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

    Number of Respondents: 16.

    Frequency of Responses: Reporting: On occasion.

    Total Burden Hours: 50.

    Ruth Brown, Departmental Information Collection Clearance Officer.
    [FR Doc. 2018-00879 Filed 1-18-18; 8:45 am] BILLING CODE 3410-34-P
    CHEMICAL SAFETY AND HAZARD INVESTIGATION BOARD Sunshine Act Meeting TIME AND DATE:

    January 31, 2018, 1:00 p.m. EST.

    PLACE:

    U.S. Chemical Safety Board, 1750 Pennsylvania Ave. NW, Suite 910, Washington, DC 20006.

    STATUS:

    Open to the public.

    MATTERS TO BE CONSIDERED:

    The Chemical Safety and Hazard Investigation Board (CSB) will convene a public meeting on Wednesday, January 31, 2018 at 1:00 p.m. EST in Washington, DC, at the CSB offices located at 1750 Pennsylvania Avenue NW, Suite 910. The Board will discuss open investigations, the status of audits from the Office of the Inspector General, financial and organizational updates, and a review of the agency's action plan. New business will include an overview of the new “Safety Spotlight” program and the CSB's 20th Anniversary.

    Additional Information

    The meeting is free and open to the public. If you require a translator or interpreter, please notify the individual listed below as the “Contact Person for Further Information,” at least three business days prior to the meeting.

    A conference call line will be provided for those who cannot attend in person. Please use the following dial-in number to join the conference:

    (888) 862-6557 Confirmation Number: 46190749

    The CSB is an independent federal agency charged with investigating incidents and hazards that result, or may result, in the catastrophic release of extremely hazardous substances. The agency's Board Members are appointed by the President and confirmed by the Senate. CSB investigations look into all aspects of chemical accidents and hazards, including physical causes such as equipment failure as well as inadequacies in regulations, industry standards, and safety management systems.

    Public Comment

    The time provided for public statements will depend upon the number of people who wish to speak. Speakers should assume that their presentations will be limited to three minutes or less, but commenters may submit written statements for the record.

    Contact Person for Further Information

    Hillary Cohen, Communications Manager, at [email protected] or (202) 446-8094. Further information about this public meeting can be found on the CSB website at: www.csb.gov.

    Dated: January 17, 2018. Raymond Porfiri, Deputy General Counsel, Chemical Safety and Hazard Investigation Board.
    [FR Doc. 2018-01066 Filed 1-17-18; 4:15 pm] BILLING CODE 6350-01-P
    DEPARTMENT OF COMMERCE International Trade Administration [C-570-074] Common Alloy Aluminum Sheet From the People's Republic of China: Postponement of Preliminary Determination in the Countervailing Duty Investigation AGENCY:

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

    DATES:

    Applicable January 19, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Yasmin Bordas at (202) 482-3813, Lana Nigro at (202) 482-1779, and John Anwesen at (202) 482-0131, AD/CVD Operations, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230.

    SUPPLEMENTARY INFORMATION:

    Background

    On November 28, 2017, the Department of Commerce (Commerce) self-initiated a countervailing duty (CVD) investigation of common alloy aluminum sheet (common alloy sheet) from the People's Republic of China.1 Currently, the preliminary determination is due no later than February 1, 2018.

    1See Common Alloy Aluminum Sheet from the People's Republic of China: Initiation of Less-Than-Fair-Value and Countervailing Duty Investigations, 82 FR 57214 (December 4, 2017) (Initiation Notice).

    Postponement of Preliminary Determination

    Section 703(b)(1) of the Tariff Act of 1930, as amended (the Act), requires Commerce to issue the preliminary determination in a countervailing duty investigation within 65 days after the date on which Commerce initiated the investigation. However, section 703(c)(1) of the Act permits Commerce to postpone the preliminary determination until no later than 130 days after the date on which Commerce initiated the investigation if: (A) The petitioner makes a timely request for a postponement; or (B) Commerce concludes that the parties concerned are cooperating, and determines that the investigation is extraordinarily complicated, and that additional time is necessary to make a preliminary determination.

    As described in the Initiation Notice, Commerce self-initiated this investigation under section 702(a) of the Act on the basis of information available to it pertaining to 26 subsidy programs.2 On December 20, 2017, Commerce selected mandatory respondents to this CVD investigation and issued countervailing duty questionnaires.3 On January 8, 2018, we received responses to the affiliation section of the CVD questionnaire from mandatory respondents Henan Mingtai Aluminum Industrial Co. Ltd. (Henan Mingtai); Yong Jie New Material Co. Ltd. (Yong Jie New Material); and Zhengzhou Mingtai Industry Co Ltd. (Zhengzhou Mingtai).4 In their responses, Henan Mingtai, Yong Jie New Material, and Zhengzhou Mingtai stated that they intend to provide complete questionnaire responses on behalf of themselves and multiple cross-owned entities.5 Given the large number of subsidy programs that Commerce is investigating in this proceeding, many of which involve complex methodological issues, and the large number of mandatory respondents and their cross-owned entities that are participating in this investigation, Commerce determines that this investigation is extraordinarily complicated and additional time is necessary to issue a preliminary determination.

    2See Initiation Notice, and accompanying Supporting Memorandum for the Initiation of Countervailing Duty Investigation of Common Alloy Aluminum Sheet from the People's Republic of China (CVD Initiation Memo), dated November 28, 2017.

    3See Memorandum, re: Countervailing Duty Investigation of Common Alloy Aluminum Sheet from the People's Republic of China: Respondent Selection, dated December 20, 2017. See also Commerce Letter, “Countervailing Duty Investigation of Common Alloy Aluminum Sheet from the People's Republic of China: Countervailing Duty Questionnaire,” dated December 20, 2017.

    4See Letter from Henan Mingtai and Zhengzhou Mingtai, “Common Alloy Aluminum Sheet from the People's Republic of China: Mingtai CVD Section III Affiliation Response,” dated January 8, 2018; Letter from Yong Jie New Material, “Common Alloy Aluminum Sheet from the People's Republic of China: Yong Jie New Material CVD Section III Affiliation Response,” dated January 8, 2018.

    5Id.

    Therefore, in accordance with section 703(c)(1)(B) of the Act, Commerce is postponing the deadline for the preliminary determination to no later than 130 days after the date on which the investigation was initiated, i.e., April 9, 2018.6 Pursuant to section 705(a)(1) of the Act and 19 CFR 351.210(b)(1), the deadline for the final determination of this investigation will continue to be 75 days after the date of the preliminary determination.

    6 Postponing the preliminary determination to 130 days after initiation would place the deadline on Saturday, April 7, 2018. Commerce's practice dictates that where a deadline falls on a weekend or federal holiday, the appropriate deadline is the next business day. See Notice of Clarification: Application of “Next Business Day” Rule for Administrative Determination Deadlines Pursuant to the Tariff Act of 1930, As Amended, 70 FR 24533 (May 10, 2005).

    This notice is issued and published pursuant to section 703(c)(2) of the Act and 19 CFR 351.205(f)(1).

    Dated: January 12, 2018. 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. 2018-00922 Filed 1-18-18; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [C-570-063] Cast Iron Soil Pipe Fittings From China: Amended Preliminary Determination of Countervailing Duty Investigation AGENCY:

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

    SUMMARY:

    On December 19, 2017, the Department of Commerce (Commerce) published in the Federal Register the preliminary determination of the countervailing duty (CVD) investigation on cast iron soil pipe fittings from the People's Republic of China (China). Commerce is amending the preliminary determination of the investigation to correct a significant ministerial error.

    DATES:

    Applicable December 19, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Dennis McClure or Jinny Ahn, AD/CVD Operations, Office VIII, Enforcement and Compliance, International Trade Administration, Department of Commerce, 14th Street and Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-5973 or (202) 482-0339, respectively.

    SUPPLEMENTARY INFORMATION:

    On December 19, 2017, Commerce published in the Federal Register the preliminary determination of the CVD investigation of cast iron soil pipe fittings from China.1 On December 18, 2017, Wor-Biz International Trading Co., Ltd. (Anhui) (Wor-Biz) timely alleged that Commerce made a significant ministerial error in the Preliminary Determination.

    1See Cast Iron Soil Pipe Fittings from the People's Republic of China: Preliminary Affirmative Countervailing Duty Determination and Alignment of Final Determination With Final Antidumping Duty Determination, 82 FR 60178 (December 19, 2017) (Preliminary Determination) and accompanying Preliminary Decision Memorandum.

    Significant Ministerial Error

    A ministerial error, as defined in section 705(e) of the Tariff Act of 1930, as amended (the Act), includes “errors in addition, subtraction, or other arithmetic function, clerical errors resulting from inaccurate copying, duplication, or the like, and any other type of unintentional error which the administering authority considers ministerial.” 2 With respect to preliminary determinations, 19 CFR 351.224(e) provides that Commerce “will analyze any comments received and, if appropriate, correct any significant ministerial error by amending the preliminary determination. . . .” A significant ministerial error is defined as an error, the correction of which, singly or in combination with other errors, would result in: (1) A change of at least five absolute percentage points in, but not less than 25 percent of, the countervailable subsidy rate calculated in the original (erroneous) preliminary determination; or (2) a difference between a countervailable subsidy rate of zero (or de minimis) and a countervailable subsidy rate of greater than de minimis, or vice versa.3

    2See also 19 CFR 351.224(f).

    3See 19 CFR 351.224(g)(1) and (2).

    Ministerial Error Allegation

    Wor-Biz alleges that, in the Preliminary Determination, Commerce erred in calculating the benchmark prices for the Provision of Pig Iron for LTAR and the Provision of Ferrous Scrap for LTAR programs by unintentionally double-counting the distance for inland freight. We agree. Therefore, as explained in the Ministerial Error Memorandum issued concurrently with this notice,4 and pursuant to 19 CFR 351.224(e) and (g), Commerce is amending the Preliminary Determination to reflect the correction of a significant ministerial error made in the calculation of the subsidy rate for Wor-Biz.

    4See Memorandum “Countervailing Duty Investigation of Cast Iron Soil Pipe Fittings from China: Allegation of Significant Ministerial Error in the Preliminary Determination,” dated concurrently with this notice (Ministerial Error Memorandum). This memorandum is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at http://access.trade.gov, and is available to all parties in the Central Records Unit, room B8024 of the main Department of Commerce building.

    Amended Preliminary Determination

    We are amending the preliminary subsidy rate for Wor-Biz pursuant to 19 CFR 351.224(e). In addition, because the preliminary “All-Others” Rate was based on the weighted average of the subsidy rates calculated for Wor-Biz and Shanxi Xuanshi Industrial Group Co., Ltd,5 we are also amending the “All-Others” rate to account for the change in Wor-Biz's subsidy rate. Further, because the adverse facts available rate assigned to the non-cooperative respondent Shijiazhuang Chengmei Import & Export Co., Ltd. was determined using, in part, the highest calculated program-specific rates determined for the cooperating respondents,6 we are also amending the adverse facts available rate to account for our correction of Wor-Biz's Provision of Pig Iron for LTAR and Provision of Ferrous Scrap for LTAR program rates.7 The revised subsidy rates are as follows:

    5See Preliminary Determination, 82 FR at 60179.

    6 For further explanation, see Preliminary Determination and accompanying Preliminary Decision Memorandum at “Use of Facts Otherwise Available and Adverse Inferences.”

    7See Ministerial Error Memorandum for additional information on the revised adverse facts available rate.

    8 This rate remains unchanged from the Preliminary Determination.

    Company Subsidy rate
  • (percent)
  • Shanxi Xuanshi Industrial Group Co., Ltd 8 8.66 Wor-Biz International Trading Co., Ltd. (Anhui) 7.37 All-Others 8.12 Shijiazhuang Chengmei Import & Export Co., Ltd 96.96

    This amended preliminary determination is published in accordance with sections 705(e) and 777(i)(1) of the Act and 19 CFR 351.224(e) and (g).

    Dated: January 12, 2018. 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. 2018-00924 Filed 1-18-18; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-475-818] Certain Pasta From Italy: Notice of Partial Rescission of Antidumping Duty Administrative Review AGENCY:

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

    DATES:

    Applicable January 19, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Joy Zhang or George McMahon, AD/CVD Operations, Office III, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-1168 or (202) 482-1167, respectively.

    SUPPLEMENTARY INFORMATION: Background

    On July 3, 2017, the Department of Commerce (Commerce) published a notice of opportunity to request an administrative review of the antidumping duty order on certain pasta from Italy.1 Pursuant to requests from interested parties,2 Commerce published in the Federal Register the notice of initiation of this antidumping duty administrative review with respect to the following companies for the period July 1, 2016, through June 30, 2017: Agritalia S.r.L. (Agritalia), Alessio Panarese Soceieta Agricola (Alessio), Antico Pastificio Morelli 1860 S.r.l. (Antico), Colussi SpA (Colussi), Francesco Tamma S.p.A. (Tamma), Ghigi 1870 S.p.A. (Ghigi), Ghigi Industria Agroalimentare in San Clemente S.r.l.,3 G.R.A.M.M. S.r.l. (GR.A.M.M.), Industria Alimentare Colavita S.p.A. (Indalco), La Molisana S.p.A. (La Molisana), Liguori Pastificio dal 1820 S.p.A. (Liguori), Pasta Zara S.p.A. (Zara), Pastificio Andalini S.p.A. (Andalini), Pastificio Fratelli DeLuca S.r.l. (DeLuca), Pastificio Menucci SpA (Menucci), Pastificio Zaffiri S.r.l. (Zaffiri), and Tesa SrL (Tesa).4

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

    2 The petitioners are Dakota Growers Pasta Company, Riviana Foods (formerly New World Pasta Company) and Treehouse Foods (formerly American Italian Pasta Company). The petitioners requested a review of Industria Alimentare Colavita S.p.A., Ghigi Industria Agroalimentare in San Clemente S.r.l. and its affiliate Pasta Zara S.p.A., and Agritalia S.r.L. See Letter from the petitioners to Commerce, “Request for 2016-2017 Administrative Reviews of the Antidumping Duty Order on Certain Pasta from ltaly,” dated July 31, 2017.

    3 In the 2015-16 antidumping duty review of Certain Pasta from Italy, Commerce determined that Ghigi 1870 S.p.A. was formerly known as Ghigi Industria Agroalimentare in San Clemente S.r.l. See Memorandum titled “2015-2016 Antidumping Duty Administrative Review of Certain Pasta from Italy: Ghigi and Zara Collapsing Memorandum,” dated July 31, 2017.

    4See Initiation of Antidumping and Countervailing Duty Administrative Reviews, 82 FR 42974 (September 13, 2017) (Initiation Notice).

    On September 18, 2017, La Molisana timely withdrew its request for a review.5 On November 13, 2017, Tamma timely withdrew its request for a review.6 On December 12, 2017, Andalini, DeLuca, GR.A.M.M., and Zaffiri timely withdrew their respective requests for an administrative review.7 No other party requested an administrative review of these particular companies.

    5See Letter from Tamma to Commerce, “Certain Pasta from Italy: Withdrawal of Antidumping Duty Administrative Review Request,” dated November 13, 2017.

    6See Letter from La Molisana to Commerce, “Certain Dry Pasta from Italy, A-475-818; Withdraw Request for Review,” dated September 18, 2017.

    7See Letter from DeLuca, GR.A.M.M., Andalini, and Zaffiri to Commerce, “Certain Dry Pasta from Italy, A-475-818; Withdraw Request for Review,” dated December 12, 2017.

    Partial Rescission of the 2016-2017 Administrative Review

    Pursuant to 19 CFR 351.213(d)(1), the Secretary will rescind an administrative review, in whole or in part, if the parties that requested a review withdraw the request within 90 days of the date of publication of the notice of initiation of the requested review. All of the aforementioned withdrawal requests were timely submitted and no other interested party requested an administrative review of these particular companies. Therefore, in accordance with 19 CFR 351.213(d)(1), and consistent with our practice,8 we are rescinding this review of the antidumping duty order on certain pasta from Italy, in part, with respect to Andalini, DeLuca, GR.A.M.M., La Molisana, Tamma, and Zaffiri.

    8See, e.g., Certain Lined Paper Products from India: Notice of Partial Rescission of Antidumping Duty Administrative Review and Extension of Time Limit for the Preliminary Results of Antidumping Duty Administrative Review, 74 FR 21781 (May 11, 2009); see also Carbon Steel Butt-Weld Pipe Fittings from Thailand: Rescission of Antidumping Duty Administrative Review, 74 FR 7218 (February 13, 2009).

    Assessment

    Commerce will instruct Customs and Border Protection (CBP) to assess antidumping duties on all appropriate entries. For the companies for which this review is rescinded, Andalini, DeLuca, GR.A.M.M., La Molisana, Tamma, and Zaffiri, antidumping duties shall be assessed at rates equal to the cash deposit of estimated antidumping duties required at the time of entry, or withdrawal from warehouse, for consumption, during the period July 1, 2016, through June 30, 2017, in accordance with 19 CFR 351.212(c)(1)(i). Commerce intends to issue appropriate assessment instructions directly to CBP 15 days after publication of this notice.

    Notification to Importers

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

    Notification Regarding Administrative Protective Order

    This notice serves as a final reminder to parties subject to administrative protective orders (APOs) of their responsibility concerning the disposition of proprietary information disclosed under an 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 is issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Tariff Act of 1930, as amended, and 19 CFR 351.213(d)(4).

    Dated: January 12, 2018. James Maeder, Senior Director performing the duties of Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations.
    [FR Doc. 2018-00923 Filed 1-18-18; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-583-008] Certain Circular Welded Carbon Steel Pipes and Tubes From Taiwan: Amended Final Results of Antidumping Duty Administrative Review; 2015-2016 AGENCY:

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

    SUMMARY:

    The Department of Commerce (Commerce) is amending the final results of the administrative review of the antidumping duty order on certain circular welded carbon steel pipes and tubes from Taiwan. The period of review (POR) is May 1, 2015, through April 30, 2016. The amended final weighted-average dumping margin is listed below in the section entitled “Amended Final Results.”

    DATES:

    Applicable January 19, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Scott Hoefke, AD/CVD Operations, Office VI, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-4947.

    SUPPLEMENTARY INFORMATION: Background

    On November 20, 2017, Commerce published the Final Results of this review in the Federal Register.1 On December 1, 2017, Shin Yang Steel Co., Ltd. (Shin Yang) timely filed a ministerial error allegation concerning the Final Results and requested, pursuant to 19 CFR 351.224, that Commerce correct the alleged ministerial error.2

    1See Certain Circular Welded Carbon Steel Pipes and Tubes from Taiwan: Final Results of Antidumping Duty Administrative Review and Final Determination of No Shipments; 2015-2016, 82 FR 55093 (November 20, 2017) (Preliminary Results), and accompanying Memorandum, “Issues and Decision Memorandum for the Final Results of Antidumping Duty Administrative Review: Certain Circular Welded Carbon Steel Pipes and Tubes from Taiwan; 2015-2016,” dated November 13, 2017 (Issues and Decision Memorandum).

    2See Shin Yang's December 1, 2017 Ministerial Error Allegation.

    Scope of the Order

    The merchandise subject to the order is certain circular welded carbon steel pipes and tubes from Taiwan. The product is currently classified under the Harmonized Tariff Schedule of the United States (HTSUS) item numbers 7306.30.5025, 7306.30.5032, 7306.30.5040, and 7306.30.5055. Although the HTSUS numbers are provided for convenience and customs purposes, the written product description remains dispositive.3

    3 For a complete description of the scope of the order, see Final Results and accompanying (Issues and Decision Memorandum). The Department is not making any changes to the scope of the order for these amended final results.

    Ministerial Error

    Section 351.224(e) of Commerce's regulations provides that Commerce will analyze any comments received and, if appropriate, correct any ministerial error by amending the final determination or the final results of the review. Section 751(h) of the Tariff Act of 1930, as amended (the Act), and 19 CFR 351.224(f) define a “ministerial error” as an error “in addition, subtraction, or other arithmetic function, clerical error resulting from inaccurate copying, duplication, or the like, and any other similar type of unintentional error which the Secretary considers ministerial.”

    We analyzed Shin Yang's ministerial error allegation and determined, in accordance with section 751(h) of the Act and 19 CFR 351.224(e) and (f), that we made a ministerial error in our calculation of Shin Yang's dumping margin. Specifically, we used an incorrect window period to identify home market sales available for matching to U.S. sales (i.e., the ENDDAY variable in Commerce's calculations program). We have now corrected the error.4

    4See memorandum, “Amended Final Results Analysis Memorandum for Shin Yang Steel Co., Ltd.” dated concurrently with this notice.

    Amended Final Results of Review

    As a result of correcting the ministerial error for this review, we determine that the following weighted-average dumping margin exists:

    Producer/Exporter Dumping
  • margin
  • (percent)
  • Shin Yang Steel Co., Ltd 1.71
    Disclosure

    We intend to disclose the calculations performed for these amended final results of review within five days of the date of publication of this notice in the Federal Register, in accordance with 19 CFR 351.224(b).

    Assessment

    Commerce shall determine, and CBP shall assess, antidumping duties on all appropriate entries covered by this review pursuant to section 751(a)(2)(C) of the Act and 19 CFR 351.212(b). For Shin Yang, because its weighted-average dumping margin is not zero or de minimis (i.e., less than 0.5 percent), Commerce has calculated importer-specific antidumping duty assessment rates. We calculated customer-specific weighted-average dumping margins by dividing the total amount of dumping for reviewed sales to the customer by the total sales quantity associated with those transactions, Commerce will direct CBP to assess customer-specific assessment rates based on the resulting per-unit rates.5 We will instruct CBP to assess antidumping duties on all appropriate entries covered by this review where a customer-specific assessment rate is not zero or de minimis. Pursuant to 19 CFR 351.106(c)(2), we will instruct CBP to liquidate without regard to antidumping duties any entries for which the importer-specific assessment rate is zero or de minimis.

    5See 19 CFR 351.212(b)(1).

    Cash Deposit Requirements

    The following cash deposit requirements will be effective for all shipments of subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date of the final results of this administrative review, as provided by section 751(a)(2) of the Act: (1) The cash deposit rates will be equal to the weighted-average dumping margins established in the final results of this review; (2) for previously reviewed or investigated companies not participating in this review, the cash deposit rate will continue to be the company-specific rate published for the most recently completed segment of this proceeding in which the company was reviewed; (3) if the exporter is not a firm covered in this review, a previous review, or the original less-than-fair-value (LTFV) investigation, but the manufacturer is, the cash deposit rate will be the rate established for the most recently completed segment of this proceeding for the manufacturer of subject merchandise; and (4) the cash deposit rate for all other manufacturers or exporters will continue to be 9.70 percent, the all-others rate established in the LTFV investigation.6 These deposit requirements, when imposed, shall remain in effect until further notice.

    6See Certain Circular Welded Carbon Steel Pipes and Tubes from Taiwan: Antidumping Duty Order, 49 FR 19369 (May 7, 1984).

    Notification to Importers

    This notice 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 Secretary's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.

    Administrative Protective Orders

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

    We are issuing and publishing these results in accordance with sections 751(a)(1) and 777(i)(1) of the Act.

    Dated: January 11, 2018. 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. 2018-00925 Filed 1-18-18; 8:45 am] BILLING CODE 3510-DS-P
    COMMITTEE FOR PURCHASE FROM PEOPLE WHO ARE BLIND OR SEVERELY DISABLED Procurement List; Proposed Addition and Deletions AGENCY:

    Committee for Purchase From People Who Are Blind or Severely Disabled.

    ACTION:

    Proposed addition to and deletions from the Procurement List.

    SUMMARY:

    The Committee is proposing to add a product to the Procurement List that will be furnished by a nonprofit agency employing persons who are blind or have other severe disabilities, and deletes products previously furnished by such agencies.

    DATES:

    Comments must be received on or before: February 18, 2018.

    ADDRESSES:

    Committee for Purchase From People Who Are Blind or Severely Disabled, 1401 S. Clark Street, Suite 715, Arlington, Virginia 22202-4149.

    FOR FURTHER INFORMATION CONTACT:

    For further information or to submit comments contact: Amy B. Jensen, Telephone: (703) 603-7740, Fax: (703) 603-0655, or email [email protected]

    SUPPLEMENTARY INFORMATION:

    This notice is published pursuant to 41 U.S.C. 8503 (a)(2) and 41 CFR 51-2.3. Its purpose is to provide interested persons an opportunity to submit comments on the proposed actions.

    Addition

    If the Committee approves the proposed addition, the entities of the Federal Government identified in this notice will be required to procure the product listed below from the nonprofit agency employing persons who are blind or have other severe disabilities.

    The following product is proposed for addition to the Procurement List for production by the nonprofit agency listed:

    Product NSN—Product Name: 2815-01-492-5709—Parts Kit, Diesel Engine Hydraulic Transmission Mandatory Source of Supply: Georgia Industries for the Blind, Bainbridge, GA Mandatory for: 100% of the requirement of the Department of Defense Contracting Activity: Defense Logistics Agency Land and Maritime Deletions

    The following products are proposed for deletion from the Procurement List:

    Products NSNs—Product Names: 6515-00-NIB-8007—Gloves, Surgical, Powder-free, Latex, Signature Glide, Translucent Yellow, Size 5.5″ 6515-00-NIB-8008—Gloves, Surgical, Powder-free, Latex, Signature Glide, Translucent Yellow, Size 6″ 6515-00-NIB-8009—Gloves, Surgical, Powder-free, Latex, Signature Glide, Translucent Yellow, Size 6.5″ 6515-00-NIB-8010—Gloves, Surgical, Powder-free, Latex, Signature Glide, Translucent Yellow, Size 7″ 6515-00-NIB-8011—Gloves, Surgical, Powder-free, Latex, Signature Glide, Translucent Yellow, Size 7.5″ 6515-00-NIB-8012—Gloves, Surgical, Powder-free, Latex, Signature Glide, Translucent Yellow, Size 8″ 6515-00-NIB-8013—Gloves, Surgical, Powder-free, Latex, Signature Glide, Translucent Yellow, Size 8.5″ 6515-00-NIB-8014—Gloves, Surgical, Powder-free, Latex, Signature Glide, Translucent Yellow, Size 9″ Mandatory Source of Supply: BOSMA Enterprises, Indianapolis, IN Contracting Activity: Department of Veterans Affairs, Strategic Acquisition Center NSNs—Product Names: 9905-01-363-0874—Sign Kit, Contaminate, 8″ x 10″, CAUTION CONTROLLED SURFACE CONTAMINATION AREA 9905-01-363-0878—Sign Kit, Contaminate, CONTROL POINT AREA, CONTROL POINT WATCH, PERMISSION REQUIRED FOR ENTRY 9905-01-454-4649—Sign Kit, Contaminate, 4″ x 5.5″, HOT SPOT, ____MR/HR, __ON CONTACT, __ON CONTACT, WITH SHIELDING 9905-01-454-4651—Sign Kit, Contaminate, 8″ x 10″, CAUTION, HIGH RADIATION AREA, NO ENTRY BY UNAUTHORIZED PERSONNEL 9905-01-454-4655—Sign Kit, Contaminate, CAUTION RADIOLOGICALLY CONTROLLED AREA/RADIOLOGICAL CONTROLS REQUIRED FOR ENT 9905-01-454-4658—Sign Kit, Contaminate, 8″ x 10″, CAUTION RADIATION AREA 9905-01-454-4663—Sign Kit, Contaminate, 8″ x 10″, CAUTION RADIOACTIVE MATERIAL Mandatory Source of Supply: Handicapped Development Center, Davenport, IA Contracting Activity: NAVSUP WEAPON SYSTEMS SUPPORT Patricia Briscoe, Deputy Director, Business Operations, Pricing and Information Management.
    [FR Doc. 2018-00904 Filed 1-18-18; 8:45 am] BILLING CODE 6353-01-P
    COMMITTEE FOR PURCHASE FROM PEOPLE WHO ARE BLIND OR SEVERELY DISABLED Procurement List; Deletions AGENCY:

    Committee for Purchase From People Who Are Blind or Severely Disabled.

    ACTION:

    Deletions from the Procurement List.

    SUMMARY:

    This action deletes products from the Procurement List previously furnished by nonprofit agencies employing persons who are blind or have other severe disabilities.

    DATES:

    Date deleted from the Procurement List: February 18, 2018.

    ADDRESSES:

    Committee for Purchase From People Who Are Blind or Severely Disabled, 1401 S. Clark Street, Suite 715, Arlington, Virginia 22202-4149.

    FOR FURTHER INFORMATION CONTACT:

    Amy B. Jensen, Telephone: (703) 603-7740, Fax: (703) 603-0655, or email [email protected]

    SUPPLEMENTARY INFORMATION: Deletions

    On 12/15/2017 (82 FR 240), the Committee for Purchase From People Who Are Blind or Severely Disabled published notice of proposed deletions from the Procurement List.

    After consideration of the relevant matter presented, the Committee has determined that the products listed below are no longer suitable for procurement by the Federal Government under 41 U.S.C. 8501-8506 and 41 CFR 51-2.4.

    Regulatory Flexibility Act Certification

    I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:

    1. The action will not result in additional reporting, recordkeeping or other compliance requirements for small entities.

    2. The action may result in authorizing small entities to furnish the products to the Government.

    3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 8501-8506) in connection with the products deleted from the Procurement List.

    End of Certification

    Accordingly, the following products are deleted from the Procurement List:

    Products NSN—Product Name: 7510-01-600-8034—Dated 2017 12-Month 2-Sided Laminated Wall Planner, 24″ × 37″ Mandatory Source of Supply: Chicago Lighthouse Industries, Chicago, IL Contracting Activity: General Services Administration, Philadelphia, PA NSN—Product Name: 3990-00-NSH-0078—Pallet, Treated Wood, 70″ × 42″ Mandatory Source of Supply: Willamette Valley Rehabilitation Center, Inc., Lebanon, OR Contracting Activity: DEPT OF JUST/FEDERAL PRISON SYSTEM NSNs—Product Names: 8415-01-542-8496—Jacket, Loft, Extreme Cold Weather Level 7, Type 2, PCU, Army, Alpha Green, MR 8415-01-542-8497—Jacket, Loft, Extreme Cold Weather Level 7, Type 1, PCU, Army, Alpha Green, LR 8415-01-542-8498—Jacket, Loft, Extreme Cold Weather Level 7, Type 2, PCU, Army, Alpha Green, XL 8415-01-542-8499—Jacket, Loft, Extreme Cold Weather Level 7, Type 2, PCU, Army, Alpha Green, LL 8415-01-542-8500—Jacket, Loft, Extreme Cold Weather Level 7, Type 2, PCU, Army, Alpha Green, XL 8415-01-542-8501—Jacket, Loft, Extreme Cold Weather Level 7, Type 2, PCU, Army, Alpha Green, XXLL 8415-01-542-8502—Jacket, Loft, Extreme Cold Weather Level 7, Type 2, PCU, Army, Alpha Green, XS 8415-01-542-8504—Jacket, Loft, Extreme Cold Weather Level 7, Type 1, PCU, Army, Alpha Green, LL 8415-01-542-8505—Jacket, Loft, Extreme Cold Weather Level 7, Type 2, PCU, Army, Alpha Green, XXXLL 8415-01-543-1605—Jacket, Loft, Extreme Cold Weather Level 7, PCU, Type 1, Army, Alpha Green, XXXL 8415-01-543-1613—Jacket, Loft, Extreme Cold Weather Level 7, Type 1, PCU, Army, Alpha Green, SR 8415-01-543-7042—Jacket, Loft, Extreme Cold Weather Level 7, Type 1, PCU, Army, Alpha Green, ML 8415-01-542-8575—Trousers, Loft Level 7, ECWCS, PCU, Army, Alpha Green, XXLL 8415-01-542-8576—Trousers, Loft Level 7, ECWCS, PCU, Army, Alpha Green, XXXLL 8415-01-542-8577—Trousers, Loft Level 7, ECWCS, PCU, Army, Alpha Green, XXXLL 8415-01-542-8580—Trousers, Loft Level 7, ECWCS, PCU, Army, Alpha Green, LL 8415-01-542-8581—Trousers, Loft Level 7, ECWCS, PCU, Army, Alpha Green, MR 8415-01-542-8582—Trousers, Loft Level 7, ECWCS, PCU, Army, Alpha Green, SR 8415-01-542-8584—Trousers, Loft Level 7, ECWCS, PCU, Army, Alpha Green, XL 8415-01-542-8586—Trousers, Loft Level 7, ECWCS, PCU, Army, Alpha Green, XXL 8415-01-542-8587—Trousers, Loft Level 7, ECWCS, PCU, Army, Alpha Green, XLL 8415-01-542-8588—Trousers, Loft Level 7, ECWCS, PCU, Army, Alpha Green, XS 8415-01-542-8589—Trousers, Loft Level 7, ECWCS, PCU, Army, Alpha Green, LR 8415-01-543-7022—Pants, Loft, Level 7, PCU, Army, Alpha Green, ML 8415-01-543-0377—Vest, Loft, Rainproof, Level 7, PCU, Army, Alpha Green, XXXLL 8415-01-543-0382—Vest, Loft, Rainproof, Level 7, PCU, Army, Alpha Green, XXL 8415-01-543-0384—Vest, Loft, Rainproof, Level 7, PCU, Army, Alpha Green, LR 8415-01-543-0386—Vest, Loft, Rainproof, Level 7, PCU, Army, Alpha Green, XXXLL 8415-01-543-0391—Vest, Loft, Level 7 Epic by Nextec, PCU, Army, Alpha Green, SR 8415-01-543-0392—Vest, Loft, Level 7 Epic by Nextec, PCU, Army, Alpha Green, MR 8415-01-543-0396—Vest, Loft, Rainproof, Level 7, PCU, Army, Alpha Green, LL 8415-01-543-0399—Vest, Loft, Rainproof, Level 7, PCU, Army, Alpha Green, XL 8415-01-543-0401—Vest, Loft, Rainproof, Level 7, PCU, Army, Alpha Green, XLL 8415-01-543-0403—Vest, Loft, Rainproof, Level 7, PCU, Army, Alpha Green, XXXLL 8415-01-543-0404—Vest, Loft, Level 7 Epic by Nextec, PCU, Army, Alpha Green, XS 8415-01-543-7044—PCU Level 7 Loft Vest Alpha Green ML Mandatory Source of Supply: Southeastern Kentucky Rehabilitation Industries, Inc., Corbin, KY 8415-01-576-2044—Jacket, Wet Weather Level 6, PCU, Army, Men's, Desert Camouflage, XSR 8415-01-576-0098—Jacket, Wet Weather Level 6, PCU, Army, Men's, Desert Camouflage, MR 8415-01-576-2048—Jacket, Wet Weather Level 6, PCU, Army, Men's, Desert Camouflage, XXL Mandatory Source of Supply: ReadyOne Industries, Inc., El Paso, TX Contracting Activity: Army Contracting Command—Aberdeen Proving Ground, Natick Contracting Division Patricia Briscoe, Deputy Director, Business Operations (Pricing and Information Management).
    [FR Doc. 2018-00935 Filed 1-18-18; 8:45 am] BILLING CODE 6353-01-P
    DEPARTMENT OF EDUCATION [Docket No. ED-2017-ICCD-0136] Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Teacher Education Assistance for College and Higher Education Grant Eligibility Regulations 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 February 20, 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-0136. 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: Teacher Education Assistance for College and Higher Education Grant Eligibility Regulations.

    OMB Control Number: 1845-0084.

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

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

    Total Estimated Number of Annual Responses: 232,324.

    Total Estimated Number of Annual Burden Hours: 36,673.

    Abstract: The Teacher Education Assistance for College and Higher Education (TEACH) Grant program is a non-need-based grant program that provides up to $4,000 per year to students who are enrolled in an eligible program and who agree to teach in a high-need field, at a low-income elementary or secondary school for at least four years within eight years of completing the program for which the Teach Grant was awarded. The TEACH Grant program regulations are required to ensure accountability of the program participants, both institutions and student recipients, for proper program administration, to determine eligibility to receive program benefits and to prevent fraud and abuse of program funds. The regulations include both record-keeping and reporting requirements. The record-keeping by the school allows for review of compliance with the regulation during on-site institutional reviews. The Department uses the required reporting to allow for close-out of institutions that are no longer participating or who lose eligibility to participate in the program.

    Dated: January 16, 2018. Kate Mullan, Acting Director, Information Collection Clearance Division, Office of the Chief Privacy Officer, Office of Management.
    [FR Doc. 2018-00921 Filed 1-18-18; 8:45 am] BILLING CODE 4000-01-P
    ENVIRONMENTAL PROTECTION AGENCY [FRL-9973-04-OW] Environmental Financial Advisory Board Meeting AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice of open meeting of the Environmental Financial Advisory Board.

    SUMMARY:

    The Environmental Protection Agency's (EPA) Environmental Financial Advisory Board (EFAB) will hold a public meeting on February 20-21, 2018. EFAB is an EPA advisory committee chartered under the Federal Advisory Committee Act to provide advice and recommendations to EPA on creative approaches to funding environmental programs, projects, and activities.

    DATES:

    The full board meeting will be held Tuesday, February 20, 2018 from 1:30 p.m.-5:00 p.m., and Wednesday, February 22, 2018 from 9:00 a.m.-5:00 p.m.

    ADDRESSES:

    Willard Intercontinental Washington Hotel, 1401 Pennsylvania Avenue, Washington, DC 20004.

    FOR FURTHER INFORMATION CONTACT:

    For information on access or services for individuals with disabilities, or to request accommodations for a disability, please contact Sandra Williams at (202) 564-4999 or [email protected], at least 10 days prior to the meeting to allow as much time as possible to process your request.

    SUPPLEMENTARY INFORMATION:

    The purpose of this meeting is to hear from informed speakers on environmental finance issues, proposed legislation, and EPA priorities; to discuss activities, progress, and preliminary recommendations with regard to current EFAB work projects; and to consider request for assistance from EPA program offices. Environmental finance discussions and presentations are expected on, but not limited to, the following topics: Predevelopment practices and funding tools that can assist local governments in evaluating public-private partnership as alternatives to current infrastructure delivery methods; developing metrics for measuring success of funding programs for water quality restoration in the Chesapeake Bay Watershed; financing and funding strategies that complement water system regionalization/consolidation; resilience investment and disaster recovery financing mechanisms; scoping and evaluation of a market-based Rural Alaska Waste Backhaul Service Program; and drinking water and clean water SRF funding to address lead fixture replacement projects. The meeting is open to the public; however, seating is limited. All members of the public who wish to attend the meeting must register, in advance, no later than Monday, January 26, 2018.

    Dated: December 22, 2017. Andrew Sawyers, Director, Office of Wastewater Management, Office of Water.
    [FR Doc. 2018-00616 Filed 1-18-18; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OEI-2011-0096; FRL-9973-06-OEI] Proposed Information Collection Request; Comment Request; Cross-Media Electronic Reporting Rule (Renewal) AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice.

    SUMMARY:

    The Environmental Protection Agency (EPA) is planning to submit an information collection request (ICR), “Cross-Media Electronic Reporting Rule” (EPA ICR No. 2002.07, OMB Control No. 2025-0003) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. Before doing so, EPA is soliciting public comments on specific aspects of the proposed information collection as described below. This is a proposed extension of the ICR, which is currently approved through July 31, 2018. 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:

    Comments must be submitted on or before March 20, 2018.

    ADDRESSES:

    Submit your comments, referencing Docket ID No. EPA-HQ-OEI-2011-0096, 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.

    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:

    Karen Seeh, Office of Environmental Information, (2823T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone number: 202-566-1175; fax number: 202-566-1684; 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.

    Pursuant to section 3506(c)(2)(A) of the PRA, EPA is soliciting comments and information to enable it to: (i) 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; (ii) 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; (iii) enhance the quality, utility, and clarity of the information to be collected; and (iv) 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. EPA will consider the comments received and amend the ICR as appropriate. The final ICR package will then be submitted to OMB for review and approval. At that time, EPA will issue another Federal Register notice to announce the submission of the ICR to OMB and the opportunity to submit additional comments to OMB.

    Abstract: The scope of this ICR is the electronic reporting components of CROMERR, which is designed to: (i) Allow EPA to comply with the Government Paperwork Elimination Act of 1998; (ii) provide a uniform, technology-neutral framework for electronic reporting across all EPA programs; (iii) allow EPA programs to offer electronic reporting as they become ready for CROMERR; and (iv) provide states with a streamlined process—together with a uniform set of standards—for approval of their electronic reporting provisions for all their EPA-authorized programs. Responses to the collection of information are voluntary. In order to accommodate CBI, the information collected must be in accordance with the confidentiality regulations set forth in 40 CFR part 2, subpart B. Additionally, EPA will ensure that the information collection procedures comply with the Privacy Act of 1974 and the OMB Circular 108.

    Form Numbers: None.

    Respondents/Affected Entities: Entities that report electronically to EPA and state or local government authorized programs; and state and local government authorized programs implementing electronic reporting.

    Respondent's Obligation To Respond: Voluntary, required to obtain or retain a benefit (Cross-Media Electronic Reporting Rule (CROMERR) established to ensure compliance with the Government Paperwork Elimination Act (GPEA)).

    Estimated Number of Respondents: 175,047 (total).

    Frequency of Response: On occasion.

    Total Estimated Burden: 112,717 hours (per year). Burden is defined at 5 CFR 1320.03(b).

    Total Estimated Cost: $5,151,934 (per year), includes $4,615,463 in annualized labor costs and $536,471 in annualized capital or operation & maintenance costs.

    Changes in Estimates: There is an increase of 63,113 hours in the total estimated respondent burden compared with the ICR currently approved by OMB. This increase occurred primarily because EPA accounted for the expected burden associated with the implementation of the e-Manifest system. (The e-Manifest Act extends the scope of the federal manifest program to include state hazardous waste, i.e., wastes regulated by a state but not EPA.) Under the e-Manifest system, all respondents that submit manifests electronically must first register with the Central Data Exchange (CDX). In addition, respondents that intend to use a PIN/Password must prepare an electronic subscriber agreement. EPA believes that the estimated number of respondents included in this ICR is a reasonable approximation of the actual respondent universe.

    Dated: January 10, 2018. Connie Dwyer, Director, Information Exchange Services Division.
    [FR Doc. 2018-00939 Filed 1-18-18; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OAR-2017-0639; FRL-9973-12-OAR] Proposed Information Collection Request; Comment Request; Recordkeeping and Reporting of the Production, Import, Export, Destruction, Transhipment, and Exempted Uses of Ozone-Depleting Substances (Renewal) AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice.

    SUMMARY:

    The Environmental Protection Agency is planning to submit an information collection request (ICR), “Recordkeeping and Reporting of the Production, Import, Export, Destruction, Transhipment, and Exempted Uses of Ozone-Depleting Substances (Renewal)” (EPA ICR No. 1432.32, OMB Control No. 2060-0170) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. Before doing so, EPA is soliciting public comments on specific aspects of the proposed information collection as described below. This is a proposed extension of the ICR, which is currently approved through August, 2018, combined with two other ICRs for ozone-depleting substances (ODS). 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:

    Comments must be submitted on or before March 20, 2018.

    ADDRESSES:

    Submit your comments, referencing Docket ID No. EPA-HQ-OAR-2017-0639 online using www.regulations.gov (our preferred method), or by mail to: EPA Docket Center, Environmental Protection Agency, Mail Code 28221T, 1200 Pennsylvania Ave. NW, Washington, DC 20460.

    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:

    Katherine Sleasman, Stratospheric Protection Division, (6205T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone number: (202) 564-7716; fax number: (202) 564-4775; 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.

    Pursuant to section 3506(c)(2)(A) of the PRA, EPA is soliciting comments and information to enable it to: (i) 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; (ii) 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; (iii) enhance the quality, utility, and clarity of the information to be collected; and (iv) 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. EPA will consider the comments received and amend the ICR as appropriate. The final ICR package will then be submitted to OMB for review and approval. At that time, EPA will issue another Federal Register notice to announce the submission of the ICR to OMB and the opportunity to submit additional comments to OMB.

    Abstract: EPA is seeking to combine multiple ICRs into a single ICR for all the recordkeeping and reporting related to the production, import, export, transformation, destruction, transhipment, and exempted uses of all ODS, and this merged renewal will allow for the option of electronic reporting and improvements to the electronic forms under Title VI of the Clean Air Act (CAA). Thus, for this ICR, EPA is renewing the existing ICR for class I ODS (ICR No. 1432.32; OMB Control No. 2060-0170) and transferring the burden under the ICR for class II ODS (EPA ICR No. 2014.07; OMB Control No. 2060-0498 Reporting and Recordkeeping Requirements of the HCFC Allowance System (Renewal)) and Methyl Bromide Critical Use Exemptions (EPA ICR No. 2031.08; OMB Control No. 2060-0482 Protection of Stratospheric Ozone: Request for Applications from Critical use Exemption for the Phase-out of Methyl Bromide (Renewal)). Both 2060-0498 and 2060-0482 will be discontinued once this ICR is approved.

    This ICR covers the requirements under the Montreal Protocol on Substances that Deplete the Ozone Layer (Protocol) and Title VI of the CAA that establish limits on total U.S. production, import, and export of class I and class II controlled ODS (or controlled substances). Under its Protocol commitments, the United States has been obligated to cease production and import of class I controlled substances (chlorofluorocarbons and others) with exemptions for essential uses, critical uses of methyl bromide, quarantine and pre-shipment uses of methyl bromide, previously used material, and material that will be transformed or destroyed. The Protocol also establishes limits and reduction schedules leading to the eventual phaseout of class II controlled substances with limited exemptions for previously used material, and material that will be transformed, destroyed, or exported to developing countries.

    Additionally, the CAA limits production and consumption of controlled substances which the EPA must adhere to and enforce. To implement the CAA provisions and satisfy commitments under the Montreal Protocol, the ODS phaseout regulations establish control measures for individual companies. EPA monitors company compliance through the recordkeeping and reporting requirements established in the regulations at 40 CFR part 82, subpart A.

    EPA is also removing reporting elements that are no longer needed, revising others to address changes to a new electronic ODS Tracking System, and consolidating forms.

    The Government Paperwork Elimination Act (GPEA, Pub. L. 105-277) requires that, when practicable, federal organizations use electronic forms, electronic filings, and electronic signatures to conduct official business with the public. EPA's Cross-Media Electronic Reporting Regulation (CROMERR) (October 13, 2005; 70 FR 59848; FRL-7977-1) provides that any requirement in Title 40 of the Code of Federal Regulations to submit a report directly to EPA can be satisfied with an electronic submission that meets certain conditions once the Agency publishes a notice that electronic document submission is available for that requirement.

    In light of GPEA and CROMERR, this action will allow all manufacturers, importers, and processors of class I and class II ODS to use the internet, through EPA's Central Data Exchange (CDX), to submit ODS reports to the Agency. Companies will be able to register with EPA to submit their data electronically to the Agency via CDX and the Agency in turn will be able to communicate back electronically with submitters through a secure system. This promotes efficiency in communications and cost savings in submissions and correspondence. The adoption of electronic communications will reduce the reporting burden on industry by reducing both the cost and the time required to review, edit and transmit data to the Agency. All information sent via CDX will be transmitted securely to protect CBI. The Agency will also benefit from receiving electronic submissions. The electronic submission process through CDX will allow for the import of data into the ODS Tracking System, which will reduce the potential for human error that exists when data are entered by hand. Agency personnel will also be able to communicate more efficiently with submitters electronically, compared to using U.S. mail.

    Upon receipt of the reports, the data is currently either entered or electronically imported into the ODS Tracking System. The ODS Tracking System is a secure database that maintains the data submitted to EPA and helps the Agency: (1) Maintain oversight over total production and consumption of controlled substances; (2) monitor compliance with limits and restrictions on production, imports, and trades and specific exemptions from the phaseout for individual U.S. companies; (3) enforce against illegal imports; and (4) assess and report on the U.S. phasedown caps established under the CAA and consistent with the Montreal Protocol.

    EPA has implemented an electronic reporting system through CDX that allows regulated entities to prepare and submit data electronically. Coupled with the widespread use of the standardized forms, electronic reporting has improved data quality and made the reporting process efficient for both reporting companies and EPA.

    EPA informs the respondents that they may assert claims of business confidentiality for any of the information they submit. Information claimed as confidential will be treated in accordance with the procedures for handling information claimed as confidential under 40 CFR part 2, subpart B, and will be disclosed to the extent, and by means of procedures, set forth in Subpart B. If no claim of confidentiality is asserted when the information is received by EPA, it may be made available to the public without further notice to the respondents (40 CFR 2.203). All information sent by the submitter via CDX is transmitted securely to protect CBI. The reporting tool guides the user through the process of submitting CBI. Documents containing information claimed as CBI must be submitted in an electronic format, in accordance with the recordkeeping requirements.

    Form Numbers: Class I Producer Quarterly Report OMB Control No. 2060-0710, Class II Producer Quarterly Report OMB Control No. 2060-0498, Methyl Bromide Producer Quarterly Report OMB Control No. 2060-0482, Class I Importer Quarterly Report OMB Control No. 2060-0170, Class II Importer Quarterly Report OMB Control No. 2060-0498, Methyl bromide Importer Quarterly Report OMB Control No 2060-0482, Class I Exporter Annual Report OMB Control No. 2060-0170, Class II Exporter Quarterly Report OMB Control No. 2060-0498, Methyl Bromide Exporter Quarterly Report OMB Control No. 2060-0482, Second-Party Destruction Annual Report OMB Control No. 2060-0170, Second-Party Transformation Annual Report OMB Control No. 2060-0170, Class I Laboratory Supplier OMB Control No. 2060-0170, Methyl Bromide Pre-2005 Stocks Annual Report OMB Control No 2060-0482, Distributor of QPS Methyl Bromide Quarterly Report OMB Control No 2060-0482, Methyl Bromide Trades Report OMB Control No. 2060-0482, Methyl Bromide Sales of Critical Use Annual Report OMB Control No 2060-0482, Class II Request for Additional Consumption Allowances OMB Control No. 2060-0498, and Class II Trades Report OMB Control No. 2060-0498.

    Respondents/Affected Entities: Entities required to comply with reporting and recordkeeping requirements include, chemical producers, importers, and exporters (CFCs and HCFCs); research and development (laboratories); and methyl bromide producers, importers, exporters, distributors, and applicators.

    Respondent's Obligation To Respond: Mandatory—Section 603(b) of the Clean Air Act.

    Estimated Number of Respondents: 106 (total).

    Frequency of Response: Quarterly, annually, and as needed.

    Total Estimated Burden: 3,811 hours (per year). Burden is defined at 5 CFR 1320.03(b).

    Total Estimated Cost: $448,470 (per year), includes $13,082.00 annualized capital or operation & maintenance costs.

    Changes in Estimates: There is a decrease of 1,644 hours in the total estimated respondent burden compared with the ICRs currently approved by OMB. This decrease compared to previous ICRs is because the merged ICR accounts for the transition from paper to electronic reporting and the decrease in the number of respondents. The reporting community continues to change as ODS are phased out. Specifically, we estimate fewer companies reporting on imports and exports of ODS. These updates are based on 2015 reporting activity. While the one-time burden associated with the transition to electronic reporting (i.e., CDX registration and electronic signature) temporarily increases burden, overall burden decreases because of the efficiencies associated with electronic reporting.

    Dated: December 20, 2017. Cynthia A. Newberg, Acting Director, Stratospheric Protection Division.
    [FR Doc. 2018-00938 Filed 1-18-18; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [ER-FRL-9037-2] Environmental Impact Statements; Notice of Availability

    Responsible Agency: Office of Federal Activities, General Information (202) 564-7156 or http://www2.epa.gov/nepa.

    Weekly receipt of Environmental Impact Statements Filed 01/08/2018 Through 01/12/2018 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. 20180001, Draft, USFS, ID, Little Boulder Project, Comment Period Ends: 03/09/2018, Contact: Stephanie Israel 208-476-8344. EIS No. 20180002, Final, FHWA, MO, I-70 Second Tier Combined Final Environmental Impact Statement and Record of Decision, Pursuant to 23 U.S.C. 139(N), The 30-day wait/review period does not apply to this FEIS, Contact: Kevin W. Ward 573-638-2600. EIS No. 20180003, Draft, USFS, NV, Mt. Rose Ski Tahoe—Atoma Area Project, Comment Period Ends: 04/19/2018, Contact: Marnie Bonesteel 775-352-1240. EIS No. 20180004, Final, BR, NM, Pojoaque Basin Regional Water System EIS, Review Period Ends: 02/20/2018, Contact: Sarah Branum 505-462-3591. EIS No. 20180005, Draft, USFS, CO, Steamboat Ski Area Improvements, Comment Period Ends: 03/05/2018, Contact: Erica Dickerman 970-870-2185. Dated: January 16, 2018. Kelly Knight, Director, NEPA Compliance Division, Office of Federal Activities.
    [FR Doc. 2018-00929 Filed 1-18-18; 8:45 am] BILLING CODE P
    EXPORT-IMPORT BANK [Public Notice 2018-3002] Agency Information Collection Activities: Comment Request AGENCY:

    Export-Import Bank of the United States

    ACTION:

    Submission for OMB review and comments request.

    SUMMARY:

    The Export-Import Bank of the United States (EXIM), as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal Agencies to comment on the proposed information collection, as required by the paperwork Reduction Act of 1995.

    The Export-Import Bank of the United States, pursuant to the Export-Import Bank Act of 1945, facilitates the finance of the export of U.S. goods and services. The “Report of Premiums Payable for Exporters Only” form will be used by exporters to report and pay premiums on insured shipments to various foreign buyers.

    DATES:

    Comments must be received on or before February 20, 2018 to be assured of consideration.

    ADDRESSES:

    Comments may be submitted electronically on WWW.REGULATIONS.GOV (EIB 92-29) or by mail to Office of Information and Regulatory Affairs, 725 17th Street NW, Washington, DC 20038, Attn: OMB 3048-0017 The application tool can be reviewed at: http://exim.gov/sites/default/files/pub/pending/eib92-29.pdf.

    SUPPLEMENTARY INFORMATION:

    Title and Form Number: EIB 92-29 Export-Import Bank Report of Premiums Payable for Exporters Only.

    OMB Number: 3048-0017.

    Type of Review: Renewal.

    Need and Use: The “Report of Premiums Payable for Exporters Only” form is used by exporters to report and pay premiums on insured shipments to various foreign buyers under the terms of the policy and to certify that premiums have been correctly computed and remitted. The `Report of Premiums Payable for Exporters Only' is used by EXIM to determine the eligibility of the shipment(s) and to calculate the premium due to EXIM for its support of the shipment(s) under its insurance program.

    Affected Public: This form affects entities involved in the export of U.S. goods and services.

    Monthly Number of Respondents: 2,600.

    Estimated Time per Respondent: 15 minutes.

    Annual Burden Hours: 7,800 hours.

    Frequency of Reporting or Use: Monthly.

    Government Expenses

    Reviewing Time per Year: 7,800 hours.

    Average Wages per Hour: $42.50.

    Average Cost per Year: $331,500.

    Benefits and Overhead: 20%.

    Total Government Cost: $397,800.

    Bassam Doughman, IT Specialist.
    [FR Doc. 2018-00888 Filed 1-18-18; 8:45 am] BILLING CODE 6690-01-P
    EXPORT-IMPORT BANK [Public Notice 2018-3003] Agency Information Collection Activities: Comment Request AGENCY:

    Export-Import Bank of the United States.

    ACTION:

    Submission for OMB review and comments request.

    SUMMARY:

    The Export-Import Bank of the United States (EXIM), as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal Agencies to comment on the proposed information collection, as required by the Paperwork Reduction Act of 1995.

    Pursuant to the Export-Import Bank Act of 1945, the Export-Import Bank of the United States (EXIM), facilitates the finance of the export of U.S. goods and services by providing insurance or guarantees to U.S. exporters or lenders financing U.S. exports. By neutralizing the effect of export credit insurance or guarantees offered by foreign governments and by absorbing credit risks that the private sector will not accept, EXIM enables U.S. exporters to compete fairly in foreign markets on the basis of price and product. In the event that a borrower defaults on a transaction insured or guaranteed by EXIM, the insured or guaranteed exporter or lender may seek payment from EXIM by the submission of a claim. This collection of information is necessary to determine if such claim complies with the terms and conditions of the relevant insurance policy or guarantee, as the case may be.

    DATES:

    Comments must be received on or before February 20, 2018 to be assured of consideration.

    ADDRESSES:

    Comments may be submitted electronically on WWW.REGULATIONS.GOV (EIB 10-05) or by mail to Office of Information and Regulatory Affairs, 725 17th Street NW, Washington, DC 20038 Attn: OMB 3048-10-05. The information collection tool can be reviewed at: http://www.exim.gov/pub/pending/eib10-05.pdf.

    SUPPLEMENTARY INFORMATION:

    Title and Form Number: EIB 10-05 Notice of Claim and Proof of Loss, Medium Term Guarantee.

    OMB Number: 3048-0035.

    Type of Review: Regular.

    Need and Use: This collection of information is necessary, pursuant to 12 U.S.C. 635(a)(1), to determine eligibility of the applicant for EXIM assistance. The information collected enables EXIM to determine the eligibility of the shipment(s) for insurance and to calculate the premium due to EXIM for its support of the shipment(s) under its insurance program.

    Affected Public: This form affects entities involved in the export of U.S. goods and services.

    Annual Number of Respondents: 65.

    Estimated Time per Respondent: 1 hour.

    Annual Burden Hours: 65 hours.

    Frequency of Reporting of Use: As needed to request a claim payment.

    Government Expenses

    Reviewing Time per Year: 65 hours.

    Average Wages per Hour: $42.50.

    Average Cost per Year: $2,762 (time*wages).

    Benefits and Overhead: 20%.

    Total Government Cost: $3,315.

    Bassam Doughman, IT Specialist.
    [FR Doc. 2018-00889 Filed 1-18-18; 8:45 am] BILLING CODE 6690-01-P
    EXPORT-IMPORT BANK [Public Notice 2018-3004] Agency Information Collection Activities: Comment Request AGENCY:

    Export-Import Bank of the United States

    ACTION:

    Submission for OMB review and comments request.

    SUMMARY:

    The Export-Import Bank of the United States (EXIM), as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal Agencies to comment on the proposed information collection, as required by the Paperwork Reduction Act of 1995.

    This collection of information is necessary, to determine eligibility of the export sales for insurance coverage. The Report of Premiums Payable for Financial Institutions Only is used to determine the eligibility of the shipment(s) and to calculate the premium due to EXIM for its support of the shipment(s) under its insurance program. EXIM customers will be able to submit this form on paper or electronically.

    By neutralizing the effect of export credit support offered by foreign governments and by absorbing credit risks that the private sector will not accept, EXIM enables U.S. exporters to compete fairly in foreign markets on the basis of price and product. Under the Working Capital Guarantee Program, EXIM provides repayment guarantees to lenders on secured, short-term working capital loans made to qualified exporters. The guarantee may be approved for a single loan or a revolving line of credit.

    In the event that a buyer defaults on a transaction insured by EXIM the insured exporter or lender may seek payment by the submission of a claim.

    DATES:

    Comments must be received on or before February 20, 2018 to be assured of consideration.

    ADDRESSES:

    Comments may be submitted electronically on WWW.REGULATIONS.GOV or by mail to Office of Information and Regulatory Affairs, 725 17th Street NW, Washington, DC 20038 Attn: OMB 3048-10-03.

    The information collection tool can be reviewed at: http://www.exim.gov/pub/pending/eib10-03.pdf (EIB 10-03).

    SUPPLEMENTARY INFORMATION:

    Title and Form Number: EIB 10-03 Notice of Claim and Proof of Loss, Export Credit Insurance Policies.

    OMB Number: 3048-0033.

    Type of Review: Regular.

    Need and Use: This collection of information is necessary, pursuant to 12 U.S.C. 635(a)(1), to determine if such claim complies with the terms and conditions of the relevant insurance policy.

    Affected Public: This form affects entities involved in the export of U.S. goods and services.

    Annual Number of Respondents: 300.

    Estimated Time per Respondent: 45 minutes.

    Annual Burden Hours: 225 hours.

    Frequency of Reporting of Use: As needed to request claim payment.

    Government Expenses

    Reviewing Time per Year: 300 hours.

    Average Wages per Hour: $42.50.

    Average Cost per Year: $12,750 (time*wages).

    Benefits and Overhead: 20%.

    Total Government Cost: $15,300.

    Bassam Doughman, IT Specialist.
    [FR Doc. 2018-00890 Filed 1-18-18; 8:45 am] BILLING CODE 6690-01-P
    EXPORT-IMPORT BANK [Public Notice: 2018-3006] Agency Information Collection Activities: Comment Request AGENCY:

    Export-Import Bank of the United States.

    ACTION:

    Submission for OMB review and comments request.

    SUMMARY:

    The Export-Import Bank of the United States (EXIM), as a part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal Agencies to comment on the proposed information collection, as required by the Paperwork Reduction Act of 1995.

    The collection provides EXIM staff with the information necessary to monitor the borrower's payments for exported goods covered under its short and medium-term export credit insurance policies. It also alerts EXIM staff of defaults, so they can manage the portfolio in an informed manner.

    DATES:

    Comments must be received on or before February 20, 2018 to be assured of consideration.

    ADDRESSES:

    Comments may be submitted electronically on WWW.REGULATIONS.GOV (EIB 92-27) or by mail to Office of Information and Regulatory Affairs, 725 17th Street NW, Washington, DC 20038, Attn: OMB 3048-0027. Form can be viewed at http://www.exim.gov/pub/pending/eib92-27.pdf.

    SUPPLEMENTARY INFORMATION:

    Title and Form Number: EIB 92-27 Report of Overdue Accounts Under Short-Term Policies.

    OMB Number: 3048-0027.

    Type of Review: Regular.

    Need and Use: The collection provides EXIM staff with the information necessary to monitor the borrower's payments for exported goods covered under its short- and medium term export credit insurance policies. It also alerts EXIM staff of defaults, so they can manage the portfolio in an informed manner.

    Affected Public: This form affects entities involved in the export of U.S. goods and services.

    Annual Number of Respondents: 745.

    Estimated Time per Respondent: 15 minutes.

    Annual Burden Hours for Respondents: 186.25 hours.

    Frequency of Reporting or Use: Monthly, until completed.

    Government Expenses:

    Reviewing Time per Year: 186.25 hours.

    Average Wages per Hour: $42.50.

    Average Cost per Year: $7,915.63 (time * wages).

    Benefits and Overhead: 20%.

    Total Government Cost: $9,498.75.

    Bassam Doughman, IT, Specialist.
    [FR Doc. 2018-00892 Filed 1-18-18; 8:45 am] BILLING CODE 6690-01-P
    EXPORT-IMPORT BANK [Public Notice 2018-3005] Agency Information Collection Activities: Comment Request AGENCY:

    Export-Import Bank of the United States.

    ACTION:

    Submission for OMB review and comments request.

    SUMMARY:

    The Export-Import Bank of the United States (EXIM), as a part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal Agencies to comment on the proposed information collection, as required by the Paperwork Reduction Act of 1995. Our customers will be able to submit this form on paper or electronically.

    This form is used by insurance brokers to register with Export-Import Bank. It provides EXIM staff with the information necessary to make a determination of the eligibility of the broker to receive commission payments under Export-Import Bank's credit insurance programs.

    DATES:

    Comments must be received on or before February 20, 2018 to be assured of consideration.

    ADDRESSES:

    Comments may be submitted electronically on WWW.REGULATIONS.GOV (EIB 92-79) or by mail to Office of Information and Regulatory Affairs, 725 17th Street NW, Washington, DC 20038 Attn: OMB 3048-0024. Form can be viewed at http://www.exim.gov/pub/pending/eib92-79.pdf.

    SUPPLEMENTARY INFORMATION:

    Title and Form Number: EIB 92-79 Broker Registration Form.

    OMB Number: 3048-0024.

    Type of Review: Regular.

    Need and Use: This form is used by insurance brokers to register with Export Import Bank. The form provides EXIM staff with the information necessary to make a determination of the eligibility of the broker to receive commission payments under Export Import Bank's credit insurance programs.

    Affected Public: This form affects entities engaged in brokering export credit insurance policies.

    Annual Number of Respondents: 17.

    Estimated Time per Respondent: 15 minutes.

    Frequency of Reporting or Use: Once every three years.

    Annual Public Burden: 4.25 hours.

    Government Expenses

    Reviewing Time/Hours: 2.

    Responses per Year: 17.

    Review Time per Year: 34 hours.

    Average Wages per Hour: $42.5.

    Wages per Year: $1,445.

    Benefits & Overhead: 20%.

    Total Government Cost: $1,734.

    Bassam Doughman, IT Specialist.
    [FR Doc. 2018-00891 Filed 1-18-18; 8:45 am] BILLING CODE 6690-01-P
    EXPORT-IMPORT BANK [Public Notice 2018-3001] Agency Information Collection Activities: Comment Request AGENCY:

    Export-Import Bank of the United States.

    ACTION:

    Submission for OMB review and comments request.

    SUMMARY:

    The Export-Import Bank of the United States (EXIM), as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal Agencies to comment on the proposed information collection, as required by the paperwork Reduction Act of 1995.

    By neutralizing the effect of export credit insurance and guarantees offered by foreign governments and by absorbing credit risks that the private section will not accept, EXIM enables U.S. exporters to compete fairly in foreign markets on the basis of price and product. This collection of information is necessary, to determine eligibility of the applicant for EXIM support. This form is used by a financial institution (or broker acting on its behalf) in order to obtain approval for non-honoring coverage of short-term letters of credit. The information received provides EXIM staff with the information necessary to make a determination of the eligibility of the applicant and transaction for EXIM assistance under its programs.

    The application can be viewed at http://www.exim.gov/sites/default/files/pub/pending/eib92-34.pdf.

    DATES:

    Comments should be received on or before February 20, 2018 to be assured of consideration.

    ADDRESSES:

    Comments may be submitted electronically on WWW.REGULATIONS.GOV (EIB 92-34) or by mail to Office of Management and Budget, Office of Information and Regulatory Affairs, 725 17th Street NW, Washington, DC 20038 Attn: OMB-3048-0009.

    SUPPLEMENTARY INFORMATION:

    Titles and Form Number: EIB 92-34 Application for Short-Term Letter of Credit Insurance Policy.

    OMB Number: 3048-0009.

    Type of Review: Regular.

    Need and Use: The information collected will provide information needed to determine compliance and creditworthiness for transaction requests submitted to the Export Import Bank.

    Affected Public: This form affects entities involved in the export of U.S. goods and services.

    Annual Number of Respondents: 11.

    Estimated Time per Respondent: 1 hours.

    Annual Burden Hours: 48 hours.

    Frequency of Reporting or Use: As needed.

    Government Expenses

    Reviewing Time per Year: 11 hours.

    Average Wages per Hour: $42.50.

    Average Cost per Year: $468 (time*wages).

    Benefits and Overhead: 20%.

    Total Government Cost: $561.

    Bassam Doughman, IT Specialist.
    [FR Doc. 2018-00887 Filed 1-18-18; 8:45 am] BILLING CODE 6690-01-P
    DEPARTMENT OF DEFENSE GENERAL SERVICES ADMINISTRATION NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [OMB Control No. 9000-0018; Docket 2017-0053; Sequence No. 1] Submission for OMB Review; Certification of Independent Price Determination, Contractor Code of Business Ethics and Compliance, and Preventing Personal Conflicts of Interest AGENCY:

    Department of Defense (DOD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA).

    ACTION:

    Notice.

    SUMMARY:

    Under the provisions of the Paperwork Reduction Act, the Regulatory Secretariat Division (MVCB) will be submitting to the Office of Management and Budget (OMB) a request for revision and an extension of existing OMB clearances concerning certification of independent price determination and parent company and identifying data.

    DATES:

    Submit comments on or before February 20, 2018.

    ADDRESSES:

    Submit comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to: Office of Information and Regulatory Affairs of OMB, Attention: Desk Officer for GSA, Room 10236, NEOB, Washington, DC 20503. Additionally submit a copy to GSA by any of the following methods:

    Regulations.gov: http://www.regulations.gov. Submit comments via the Federal eRulemaking portal by searching the OMB control number 9000-0018. Select the link “Comment Now” that corresponds with “Information Collection 9000-0018, “Certification of Independent Price Determination, Contractor Code of Business Ethics and Compliance, and Preventing Personal Conflicts of Interest.” Follow the instructions provided on the screen. Please include your name, company name (if any), and “Information Collection 9000-0018, “Certification of Independent Price Determination, Contractor Code of Business Ethics and Compliance, and Preventing Personal Conflicts of Interest” on your attached document.

    Mail: General Services Administration, Regulatory Secretariat Division (MVCB), 1800 F Street NW, Washington, DC 20405. ATTN: Ms. Mandell/IC 9000-0018.

    Instructions: Please submit comments only and cite Information Collection 9000-0018, in all correspondence related to this collection. Comments received generally will be posted without change to http://www.regulations.gov, including any personal and/or business confidential information provided. To confirm receipt of your comment(s), please check www.regulations.gov, approximately two to three days after submission to verify posting (except allow 30 days for posting of comments submitted by mail).

    FOR FURTHER INFORMATION CONTACT:

    Ms. Cecelia L. Davis, Procurement Analyst, Federal Acquisition Policy Division, GSA 202-219-0202 or [email protected]

    SUPPLEMENTARY INFORMATION:

    A. Purpose

    This information collection requirement, OMB Control No. 9000-0018, currently titled “Certification of Independent Price Determination and Parent Company and Identifying Data,” is proposed to be retitled “Certification of Independent Price Determination, Contractor Code of Business Ethics and Compliance, and Preventing Personal Conflicts of Interest,” due to consolidation with two additional currently approved information collection requirements: OMB Control No. 9000-0164, Contractor Business Ethics Compliance Program and Disclosure Requirements; and OMB Control No. 9000-0183, Preventing Personal Conflicts of Interest for Contractor Employees Performing Acquisition Functions.

    DoD, GSA and NASA analyzed the FY 2016 data from the Federal Procurement Data System (FPDS) to develop the estimated burden hours for this information collection.

    This information collection requirement pertains to information that an offeror contractor must submit in response to the requirements of the following provisions and clauses in FAR 52.203:

    1. Certification of Independent Price Determination (FAR 52.203-2). This clause requires the offeror to certify that the prices in the offer have been arrived at independently. Agencies are required to report under 41 U.S.C. 3101 (formerly 41 U.S.C. 252(b)(i)) and 10 U.S.C. 2305(d) suspected violations of the antitrust laws (e.g., collusive bidding, identical bids, uniform estimating systems, etc.) to the Attorney General.

    As a first step in assuring that Government contracts are not awarded to firms violating such antitrust laws, offerors on Government contracts must complete the certificate of independent price determination. An offer will not be considered for award where the certificate has been deleted or modified. Deletions or modifications of the certificate and suspected false certificates are reported to the Attorney General (see FAR 3.103-2 Evaluating the Certification).

    The information collection is required each time an offeror responds to a solicitation for firm-fixed price contract or fixed-price economic price adjustment contract unless the acquisition is: (1) Made under the simplified acquisition threshold; (2) at the request for technical proposals under two-step sealed bidding procedures; or (3) for utility services for which rates are set by law or regulation. The FAR rule requires a Certificate of Independent Price Determination so that contractors certify that the prices in their offer have been arrived at independently, have not been or will not be knowingly disclosed, and have not been submitted for the purpose of restricting competition. This clause does not apply to commercial items.

    2. Contractor Code of Business Ethics and Conduct (FAR 52.203-13). This clause implements Government policy and Public Law 110-252, Title VI (Close the Contractor Fraud Loophole Act). It requires contractors to notify the respective agency Office of Inspector General when the contractor has credible evidence that the contractor's principal, employee, agent, or subcontractor committed a violation of certain Federal criminal laws, or a violation of the Civil False Claims Act.

    The objective of the notification requirement is to emphasize the critical importance of integrity in contracting and reduce the occurrence of improper or criminal conduct in connection with the award and performance of Federal contracts and subcontracts. Information obtained from the notification requirements will be provided to the agency Inspector General by the contractor.

    3. Preventing Personal Conflicts of Interest (FAR 52.203-16). In accordance with 41 U.S.C. 2303, this clause requires contractors and subcontractors to: (a) Identify and prevent personal conflicts of interest of their covered employees; and (b) prohibit covered employees who have access to non-public information by reason of performance on a Government contract from using such information for personal gain. Contractors are required to notify contracting officers whenever they become aware of any personal conflict of interest violations by a covered employee. The objective of the notification requirement is to emphasize the critical importance of integrity in contracting and reduce the occurrence of improper or criminal conduct in connection with the award and performance of Federal contracts and subcontracts. Information obtained from the notification requirements will be provided to the agency Inspector General by the contractor. In addition, contractors have the opportunity, in exceptional circumstances, to request mitigation or waiver of the personal conflict-of-interest standards. The information is used by the Government to evaluate the requested mitigation/waiver.

    The information provided to and by contractors in accordance with the clause at FAR 52.203-16 is used by the contractor and the contracting officer to identify and mitigate personal conflicts of interest in compliance with Government policy to (a) identify and prevent personal conflicts of interest of covered employees; and (b) prohibit covered employees who have access to non-public information by reason of performance on a Government contract from using such information for personal gain (FAR 3.1102). A notice was published in the Federal Register at 82 FR 40582 on August 25, 2017. No comments were received.

    B. Annual Reporting Burden

    1. Certification of Independent Price Determination (FAR 52.203-2).

    Respondents: 24,270.

    Responses annually: 30.

    Total annual responses: 721,200.

    Estimated hrs/response: .25.

    Estimated total burden/hrs: 180,300.

    2. Contractor Code of Business Ethics and Conduct (FAR 52.203-13).

    Respondents: 278.

    Responses per respondent: 1.

    Total annual responses: 278.

    Preparation hours per response: 60.

    Total response burden hours: 16,680.

    3. Preventing Personal Conflicts of Interest (FAR 52.203-16).

    Respondents: 120.

    Responses per respondent: 1.

    Total responses: 120.

    Burden hours per response: 30.

    Total response burden hours: 3,600.

    Recordkeeping burden:

    Number of recordkeepers: 8,598.

    Records per recordkeeper per year: 25.

    Total annual records: 214,950.

    Estimated hours per record: 2.0.

    Total recordkeeping burden hours: 429,900.

    4. Total (counting recordkeepers with respondents)

    Recordkeepers and respondents: 33,266.

    Responses: 721,598.

    Hours (reporting and recordkeeping): 707,862.

    C. Public Comments

    Public comments are particularly invited on: Whether this collection of information is necessary for the proper performance of functions of the FAR, and whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology; ways to enhance the quality, utility, and clarity of the information to be collected; and ways in which we can minimize the burden of the collection of information on those who are to respond, through the use of appropriate technological collection techniques or other forms of information technology.

    Obtaining Copies of Proposals: Requesters may obtain a copy of the information collection documents from the General Services Administration, Regulatory Secretariat Division (MVCB), 1800 F Street NW, Washington, DC 20405, telephone 202-501-4755.

    Please cite OMB Control No. 9000-0018, Certification of Independent Price Determination, Contractor Code of Business Ethics and Compliance, and Preventing Personal Conflicts of Interest, in all correspondence.

    Dated: January 16, 2018. Lorin S. Curit, Director, Federal Acquisition Policy Division, Office of Government-Wide Acquisition Policy, Office of Acquisition Policy, Office of Government-Wide Policy.
    [FR Doc. 2018-00934 Filed 1-18-18; 8:45 am] BILLING CODE 6820-EP-P
    DEPARTMENT OF DEFENSE GENERAL SERVICES ADMINISTRATION NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [OMB Control No. 9000-0064; Docket 2017-0053; Sequence 16] Submission for OMB Review; Organization and Direction of Work AGENCY:

    Department of Defense (DOD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA).

    ACTION:

    Notice of request for public comments regarding an extension to an existing OMB clearance.

    SUMMARY:

    Under the provisions of the Paperwork Reduction Act, the Regulatory Secretariat Division will be submitting to the Office of Management and Budget (OMB) a request to review and approve an extension of a previously approved information collection requirement concerning organization and direction of work.

    DATES:

    Submit comments on or before February 20, 2018.

    ADDRESSES:

    Submit comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to: Office of Information and Regulatory Affairs of OMB, Attention: Desk Officer for GSA, Room 10236, NEOB, Washington, DC 20503. Additionally submit a copy to GSA by any of the following methods:

    Regulations.gov: http://www.regulations.gov.

    Submit comments via the Federal eRulemaking portal by searching the OMB Control number 9000-0064. Select the link “Comment Now” that corresponds with “Information Collection 9000-0064, Organization and Direction of Work”. Follow the instructions provided on the screen. Please include your name, company name (if any), and “Information Collection 9000-0064, Organization and Direction of Work”, on your attached document.

    Mail: General Services Administration, Regulatory Secretariat Division (MVCB), 1800 F Street NW, Washington, DC 20405-0001. ATTN: Ms. Mandell/IC 9000-0064, Organization and Direction of Work.

    Instructions: Please submit comments only and cite Information Collection 9000-0064, Organization and Direction of Work, in all correspondence related to this collection. All comments received will be posted without change to http://www.regulations.gov, including any personal and/or business confidential information provided.

    FOR FURTHER INFORMATION CONTACT:

    Mr. Curtis E. Glover, Sr. Procurement Analyst, Federal Acquisition Policy Division, GSA, telephone 202-501-1448, or via email at [email protected]

    SUPPLEMENTARY INFORMATION: A. Purpose

    When the Government awards a cost-reimbursement construction contract, the contractor must submit to the contracting officer—and keep current a chart showing the general executive and administrative organization—the personnel to be employed in connection with the work under the contract, and their respective duties. The chart is used in the administration of the contract and as an aid in determining cost. The chart is used by contract administration personnel to assure the work is being properly accomplished at reasonable prices.

    The burden hours under FAR 52.236-19 were reduced based on FY 2017 FPDS data that showed the actual number of respondents for this type of requirement. A notice published in the Federal Register at 82 FR 51254 on November 3, 2017. No comments were received.

    B. Annual Reporting Burden

    Respondents: 19.

    Responses per Respondent: 1.

    Annual Responses: 19.

    Hours per Response: .75.

    Total Burden Hours: 14.

    C. Public Comments

    Public comments are particularly invited on: Whether this collection of information is necessary for the proper performance of functions of the FAR, and whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology; ways to enhance the quality, utility, and clarity of the information to be collected; and ways in which we can minimize the burden of the collection of information on those who are to respond, through the use of appropriate technological collection techniques or other forms of information technology.

    Obtaining Copies of Proposals: Requesters may obtain a copy of the information collection documents from the General Services Administration, Regulatory Secretariat Division (MVCB), 1800 F Street NW, Washington, DC 20405, telephone 202-501-4755.

    Please cite OMB Control No. 9000-0064, Organization and Direction of Work, in all correspondence.

    Dated: January 16, 2018. Lorin S. Curit, Director, Federal Acquisition Policy Division, Office of Government-wide Acquisition Policy, Office of Acquisition Policy, Office of Government-wide Policy.
    [FR Doc. 2018-00931 Filed 1-18-18; 8:45 am] BILLING CODE 6820-EP-P
    GULF COAST ECOSYSTEM RESTORATION COUNCIL [Docket No: 101122018-1111-01] Senior Executive Service Performance Review Board Membership AGENCY:

    Gulf Coast Ecosystem Restoration Council (GCERC).

    ACTION:

    Notice of Performance Review Board (PRB) appointments.

    SUMMARY:

    This notice announces the members of the Senior Executive Service (SES) Performance Review Board. The PRB is comprised of a Chairperson and a mix of state representatives and career senior executives that meet annually to review and evaluate performance appraisal documents and provides a written recommendation to the Chairperson of the Council for final approval of each executive's performance rating, performance-based pay adjustment, and performance award.

    DATES:

    The board membership is applicable beginning on January 8, 2018 and ending on March 8, 2019.

    FOR FURTHER INFORMATION CONTACT:

    Mary C. Pleffner, Chief Financial Officer and Director of Administration, Gulf Coast Ecosystem Restoration Council, telephone 813-394-2185.

    SUPPLEMENTARY INFORMATION:

    In accordance with 5 U.S.C. 4314(c)(4), the persons named below have been selected to serve on the PRB:

    Gulf Coast Ecosystem Restoration Council, Scaggs, Benjamin, Acting Executive Director.

    Environmental Protection Agency, Walker, Mary, Director Water Protection Division, EPA Region 4.

    United States Coast Guard, Dana S. Tulis, Director of Incident Management & Preparedness Policy.

    State of Mississippi, Rikard, Gary, Executive Director of the Mississippi Department of Environmental Quality.

    State of Louisiana, Barnes, Chris, Legal Advisor, Coastal Activities.

    Keala J. Hughes, Director of External Affairs & Tribal Relations, Gulf Coast Ecosystem Restoration Council.
    [FR Doc. 2018-00823 Filed 1-18-18; 8:45 am] BILLING CODE 6560-58-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-18-18FO; Docket No. CDC-2018-0012] Proposed Data Collection Submitted for Public Comment and Recommendations AGENCY:

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

    ACTION:

    Notice with comment period.

    SUMMARY:

    The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled “DELTA Impact Recipient Monitoring and Assessment Tools.” Information collected will be used for implementation and performance monitoring of cooperative agreement CDC-RFA-CE18-1801: Domestic Violence Prevention Enhancement and Leadership through Alliances (DELTA) Impact.

    DATES:

    CDC must receive written comments on or before March 20, 2018.

    ADDRESSES:

    You may submit comments, identified by Docket No. CDC-2018-0012 by any of the following methods:

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

    Mail: Leroy A. Richardson, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS-D74, Atlanta, Georgia 30329.

    Instructions: All submissions received must include the agency name and Docket Number. CDC will post, without change, all relevant comments to Regulations.gov.

    Please note: Submit all comments through the Federal eRulemaking portal (regulations.gov) or by U.S. mail to the address listed above.

    FOR FURTHER INFORMATION CONTACT:

    To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Leroy A. Richardson, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to the OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.

    The OMB is particularly interested in comments that will help:

    1. Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

    2. Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

    3. Enhance the quality, utility, and clarity of the information to be collected; and

    4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses.

    5. Assess information collection costs.

    Proposed Project

    DELTA Impact Recipient Monitoring and Assessment Tools—New—National Center for Injury Prevention and Control (NCIPC), Centers for Disease Control and Prevention (CDC).

    Background and Brief Description

    The Centers for Disease Control and Prevention (CDC) seeks a three-year OMB approval for a new information collection project that involves 10 recipients (State Domestic Violence Coalitions) funded through CDC's Domestic Violence Prevention Enhancements and Leadership Through Alliances (DELTA) Impact Program cooperative agreement (NOFO CDC-RFA-CE18-1801). DELTA Impact recipients will report activity information to CDC annually. The Annual Progress Report (APR) tool and Prevention Infrastructure Assessment are designed to address four key program evaluation questions as well as performance reporting requirements established by CDC's Office of Financial Resources (OFR, formerly the Procurement and Grants Office).

    Monitoring allows CDC to determine whether a recipient is meeting performance and budget goals and to make adjustments in the type and level of technical assistance provided to them, as needed, to support attainment of their performance measures. Program monitoring and program evaluation activities also allow CDC to identify and disseminate information about successful prevention strategies implemented by recipients.

    These functions are central to the NCIPC's broad mission of protecting Americans from violence and injury threats. This information collection will enable the accurate, reliable, uniform, and timely submission to CDC of each recipient's work plan and progress reports, including strategy implementation, program evaluation and performance measures. It will also enable CDC to evaluate the program across all funded recipients.

    CDC will use the information collected to look at the aggregate impact of program activities on program outcomes across all 10 recipients. The information collection will allow CDC to monitor the increased emphasis on strategies that affect health outcomes and impact, and is expected to reduce duplication of effort, enhance program impact and maximize the use of federal funds. CDC will be able to generate reports that summarize their activities and progress towards meeting work plan strategies and performance measure targets. In addition to CDC's tracking of program goals and outcomes, the data collected will provide a way for recipients to track their own activities and funding to local organizations as required by legislation. CDC will also have the capacity to generate reports that describe activities across multiple recipients and will be able to provide this information back to recipients or to respond to inquiries from HHS, the White House, Congress and other stakeholders about the national DELTA Impact Program activities and their impact.

    The total estimated annualized time burden for this collection is 123 hours. The only cost to respondents will be time spent responding to the surveys.

    Estimated Annualized Burden Hours Type of respondents Form name Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Average
  • burden per
  • response
  • (in hours)
  • Total burden
  • (in hours)
  • DELTA Impact Program Recipients State Domestic Violence Coalitions APR Tool—Year 1 10 1 15 150 APR Tool—Years 2 and 3 10 1 10 100 Prevention Infrastructure Assessment 10 1 1 10 Total 123
    Leroy A. Richardson, Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention.
    [FR Doc. 2018-00926 Filed 1-18-18; 8:45 am] BILLING CODE 4163-18-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-10549 and CMS-10455] Agency Information Collection Activities: Submission for OMB Review; Comment Request AGENCY:

    Centers for Medicare & Medicaid Services, Department of Health and Human Services.

    ACTION:

    Notice.

    SUMMARY:

    The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (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 February 20, 2018.

    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' website address at website 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: New Technology Payments for APCs Under the Outpatient Prospective Payment System; Use: CMS needs to keep pace with emerging new technologies and make them accessible to Medicare beneficiaries in a timely manner. It is necessary that we continue to collect appropriate information from interested parties such as hospitals, medical device manufacturers, pharmaceutical companies and others that bring to our attention specific services that they wish us to evaluate for New Technology APC payment. We are making no changes to the information that we collect. The information that we seek to continue to collect is necessary to determine whether certain new services are eligible for payment in New Technology APCs, to determine appropriate coding and to set an appropriate 4 payment rate for the new technology service. The intent of these provisions is to ensure timely beneficiary access to new and appropriate technologies. Form Number: CMS-10054 (OMB control number: 0938-0860); Frequency: Annually; Affected Public: Private Sector (Business or other For-profits); Number of Respondents: 10; Total Annual Responses: 10; Total Annual Hours: 160. (For policy questions regarding this collection contact Joshua McFeeters at 410-786-9732).

    2. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Report of a Hospital Death Associated with Restraint or Seclusion; Use: The regulation that was published on May, 16, 2012 (77 FR 29074) included a reduction in the reporting requirement related to hospital deaths associated with the use of restraint or seclusion, § 482.13(g). Hospitals must use Form CMS-10455 to report those deaths associated with restraint and/or seclusion directly to the Centers for Medicare & Medicaid Services (CMS) Regional Office (RO). This requirement also applies to rehabilitation or psychiatric distinct part units (DPUs) in Critical Access Hospitals (CAHs). The RO must provide hospitals with instructions for submitting the form fax and/or email, based on RO preference. Hospitals are no longer required to report to CMS those deaths where there was no use of seclusion and the only restraint was 2-point soft wrist restraints beginning in May 9, 2014. This reporting requirement change resulted in no necessary edits to the form CMS-10455 as soft wrist restraints may be used in combination with other types of restraints. It was estimated that this would reduce the volume of reports that must be submitted by 90 percent for hospitals. In addition, the final rule replaced the previous requirement for reporting via telephone to CMS, which proved to be cumbersome for both CMS and hospitals, with a requirement that allows submission of reports via telephone, facsimile or electronically, as determined by CMS.

    Form CMS-10455 is being revised in order to obtain the necessary information for the ROs to make a determination whether or not to authorize an on-site investigation related to the details surrounding the death of individuals associated with restraint and/or seclusion. Form Number: CMS-10455 (OMB control number: 0938-1210); Frequency: Occasionally; Affected Public: Private Sector; Number of Respondents: 6,389; Number of Responses: 6,389; Total Annual Hours: 2,619. (For policy questions regarding this collection contact Karina Meushaw at 410-786-1000.)

    Dated: January 12, 2018. Martique Jones, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs.
    [FR Doc. 2018-00834 Filed 1-18-18; 8:45 am] BILLING CODE 4120-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-10390] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY:

    Centers for Medicare & Medicaid Services, Department of Health and Human Services.

    ACTION:

    Notice.

    SUMMARY:

    The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

    DATES:

    Comments must be received by March 20, 2018.

    ADDRESSES:

    When commenting, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in any one of the following ways:

    1. Electronically. You may send your comments electronically to http://www.regulations.gov. Follow the instructions for “Comment or Submission” or “More Search Options” to find the information collection document(s) that are accepting comments.

    2. By regular mail. You may mail written comments to the following address: CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention: Document Identifier/OMB Control Number ___, Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850.

    To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following:

    1. Access CMS' website address at http://www.cms.hhs.gov/PaperworkReductionActof1995.

    2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to [email protected]

    3. Call the Reports Clearance Office at (410) 786-1326.

    FOR FURTHER INFORMATION CONTACT:

    William Parham at (410) 786-4669.

    SUPPLEMENTARY INFORMATION:

    Contents

    This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection's supporting statement and associated materials (see ADDRESSES).

    CMS-10390 Hospice Quality Reporting Program

    Under the PRA (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA requires federal agencies to publish a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice.

    Information Collection

    Type of Information Collection Request: Extension of a currently approved collection without change; Title of Information Collection: Hospice Quality Reporting Program; Use: The Hospice Item Set (HIS) is a standardized, patient-level data collection tool developed specifically for use by hospices. It is currently used for the collection of quality measure data pertaining to the Hospice Quality Reporting Program (HQRP). Since April 1, 2017, hospices have been using the HIS V2.00.0 which specifies the collection of data items that support eight National Quality Forum (NQF) endorsed Quality Measures (QMs) and an additional measure pair for hospice. All Medicare-certified hospice providers are required to submit HIS admission and discharge records to CMS for each patient admission and discharge. The HIS contains data elements that are used by the CMS to calculate these measures and also allows CMS to collect quality data from hospices in compliance with Section 3004 of the Affordable Care Act. Form Number: CMS-10390 (OMB control number: 0938-1153); Frequency: On Occasion; Affected Public: State, Local, or Tribal Governments, Private Sector (not-for-profit institutions); individuals or households; Number of Respondents: 4,259; Total Annual Responses: 4,259; Total Annual Hours: 686,630. For policy questions regarding this collection contact Cindy Massuda at (410) 786-0652.

    Dated: January 12, 2018. Martique Jones, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs.
    [FR Doc. 2018-00832 Filed 1-18-18; 8:45 am] BILLING CODE 4120-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-D-1267] Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of availability.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled “Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act.” For a drug product compounded by an outsourcing facility to qualify for the exemptions under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act), it must not be essentially a copy of one or more approved drug products and must meet other conditions in section 503B. This guidance sets forth FDA's policies concerning the “essentially a copy” provision of section 503B of the FD&C Act.

    DATES:

    The announcement of the guidance is published in the Federal Register on January 19, 2018.

    ADDRESSES:

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

    Electronic Submissions

    Submit electronic comments in the following way:

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

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

    Written/Paper Submissions

    Submit written/paper submissions as follows:

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

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

    Instructions: All submissions received must include the Docket No. FDA-2016-D-1267 for “Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

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

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

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

    Submit written requests for single copies of the guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document.

    FOR FURTHER INFORMATION CONTACT:

    Sara Rothman, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 5197, Silver Spring, MD 20993, 301-796-3110.

    SUPPLEMENTARY INFORMATION:

    I. Background

    FDA is announcing the availability of a guidance for industry entitled “Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act.” In 2013, the Drug Quality and Security Act, created new section 503B of the FD&C Act (21 U.S.C. 353b), which describes a new category of compounders called outsourcing facilities. Section 503B of the FD&C Act describes the conditions that must be satisfied for human drug products compounded by or under the direct supervision of a licensed pharmacist in an outsourcing facility to qualify for exemptions from the following three sections of the FD&C Act:

    • Section 502(f)(1) (21 U.S.C. 352(f)(1)) (concerning labeling of drugs with adequate directions for use);

    • Section 505 (21 U.S.C. 355) (concerning the approval of drugs under new drug applications or abbreviated new drug applications); and

    • Section 582 (21 U.S.C. 360eee-1) (concerning drug supply chain security requirements).

    One of the conditions that must be met for a compounded drug product to qualify for the exemptions under section 503B of the FD&C Act is that the drug is not essentially a copy of one or more approved drugs (section 503B(a)(5)).

    Section 503B(d)(2) defines essentially a copy of an approved drug as:

    • A drug that is identical or nearly identical to an approved drug, or a marketed drug not subject to section 503(b) and not subject to approval in an application submitted under section 505, unless, in the case of an approved drug, the drug appears on the drug shortage list in effect under section 506E at the time of compounding, distribution, and dispensing (section 503B(d)(2)(A)) or

    • a drug, a component of which is a bulk drug substance that is a component of an approved drug or a marketed drug that is not subject to section 503(b) and not subject to approval in an application submitted under section 505, unless there is a change that produces for an individual patient a clinical difference, as determined by the prescribing practitioner, between the compounded drug and the comparable approved drug (section 503B(d)(2)(B)).

    This guidance sets forth FDA's policies concerning the “essentially a copy” provision of section 503B of the FD&C Act.

    In the Federal Register of July 11, 2016 (81 FR 44879), FDA issued a notice announcing the availability of the draft version of this guidance. The comment period on the draft guidance ended on October 11, 2016. FDA received 29 comments on the draft guidance. In response to received comments or on its own initiative, FDA made several changes. For example, in response to requests in comments for direction on records retention, FDA added a recommendation that compounders maintain the records described in the guidance for at least 3 years. In addition, to address questions raised in comments, FDA clarified that the Agency does not intend to take action against an outsourcing facility for failing to compound in accordance with section 503B(a)(5) if it fills orders for a compounded drug that is essentially a copy of an approved drug that has been discontinued and is no longer marketed.

    FDA received comments from hospital organizations regarding the potential implications of proposed policies for the preparation of compounded drugs used in in-patient settings. The final guidance notes that FDA is considering the applicability of the policies described in this guidance to hospitals and health systems. We recognize that this issue is of interest to many stakeholders and will publicly convey our further thinking on the applicability of these policies to hospitals and health systems with an opportunity for comment.

    This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). This guidance represents the current thinking of FDA on “Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.

    II. Paperwork Reduction Act of 1995

    This guidance contains collections of information that are subject to review by OMB under the PRA (44 U.S.C. 3501-3520). Under the PRA, Federal Agencies must obtain approval from 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 and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, in the Federal Register of July 11, 2016, we gave interested persons 60 days to comment on the information collection provisions in the draft guidance.

    The information collection provisions in this guidance have been submitted to OMB for review as required by section 3507(d) of the PRA. These provisions are not in effect until they display a currently valid OMB control number. FDA will publish a notice in the Federal Register announcing OMB's decision regarding the information collection provisions in this guidance.

    III. Electronic Access

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

    Dated: January 16, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-00914 Filed 1-18-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-D-1525] Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application; Guidance for Industry; Availability AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of availability.

    SUMMARY:

    The Food and Drug Administration (FDA or the Agency) is announcing the availability of a final guidance for industry entitled “Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application.” This final guidance describes the conditions under which FDA does not intend to take action against a State-licensed pharmacy, a Federal facility, or an outsourcing facility that mixes, dilutes, or repackages certain biological products outside the scope of an approved biologics license application (BLA). It also describes the conditions under which FDA does not intend to take action when a State-licensed pharmacy, a Federal facility, an outsourcing facility, or a physician prepares prescription sets of allergenic extracts for subcutaneous immunotherapy.

    DATES:

    The announcement of the guidance is published in the Federal Register on January 19, 2018.

    ADDRESSES:

    You may submit 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-1525 for “Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application.” 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 http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

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

    Submit written requests for single copies of this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002; or the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

    FOR FURTHER INFORMATION CONTACT:

    Sara Rothman, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 5197, Silver Spring, MD 20903, 301-796-3110; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.

    SUPPLEMENTARY INFORMATION:

    I. Background

    FDA is announcing the availability of a final guidance for industry entitled “Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application.” Certain licensed biological products may sometimes be mixed, diluted, or repackaged in a way not described in the approved labeling for the product to meet the needs of a specific patient. For example, for some biological products there is no licensed pediatric strength and/or dosage form. In addition, there may be certain circumstances when a person would remove a licensed biological product from its original container and place it into a different container(s) (repackage it), in a manner that is not within the scope of the approved labeling for the product. As described in the guidance, mixed, diluted, or repackaged biological products are not eligible for the statutory exemptions available to certain compounded drugs under sections 503A and 503B of the FD&C Act (21 U.S.C. 353a and 353b). In addition, a biological product that is mixed, diluted, or repackaged outside the scope of an approved BLA is considered an unlicensed biological product under section 351 of the Public Health Service (PHS) Act (42 U.S.C. 262).

    This guidance describes the conditions under which FDA does not intend to take action for violations of section 351 of the PHS Act, and section 502(f)(1) (21 U.S.C. 352(f)(1)), section 582 (21 U.S.C. 360eee-1), and where specified, section 501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)) of the FD&C Act, when a state-licensed pharmacy, a Federal facility, or an outsourcing facility dilutes, mixes, or repackages certain biological products outside the scope of an approved BLA.

    In the Federal Register of January 13, 2017 (82 FR 4358), FDA issued a notice announcing the availability of the revised draft version of this guidance. The comment period on the draft guidance ended on March 14, 2017. FDA received 11 comments on the revised draft guidance. In response to received comments or on its own initiative, FDA made revisions to clarify certain points. For example, FDA added a footnote indicating that the Agency is considering the applicability of the policies described in this guidance to hospitals and health systems and intends to address these issues in separate guidance. FDA also clarified that one of the conditions under which the Agency does not intend to take action for the violations listed above is that any components used in mixing or diluting a licensed biological product are sterile, pharmaceutical grade, and otherwise appropriate for such use.

    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 mixing, diluting, or repackaging biological products outside the scope of an approved BLA. 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.

    II. Paperwork Reduction Act of 1995

    This guidance contains collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520). Under the PRA, Federal Agencies must obtain approval from 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 and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, in the Federal Register of January 13, 2017, we gave interested persons 60 days to comment on the information collection provisions in the draft guidance (82 FR 4358 at 4359).

    The information collection provisions in this guidance will be submitted to OMB for review as required by section 3507(d) of the PRA. These provisions are not in effect until they display a currently valid OMB control number. FDA will publish a notice in the Federal Register announcing OMB's decision regarding the information collection provisions in this guidance.

    The guidance also references registration and adverse event reporting for outsourcing facilities. The collections of information for outsourcing facility registration have been approved by OMB under OMB control number 0910-0777. The collections of information for adverse event reporting by outsourcing facilities have been approved by OMB under OMB control number 0910-0800.

    III. Electronic Access

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

    Dated: January 16, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-00916 Filed 1-18-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-D-7011] Laser Products—Conformance With IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (Laser Notice No. 56); Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of availability.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled “Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (Laser Notice No. 56).” This draft guidance describes the Agency's proposed approach regarding compliance with FDA's performance standards for laser products. FDA believes that under the circumstances described in this guidance, conformance with certain International Electrotechnical Commission (IEC) standards would provide adequate protection of the public health and safety for laser products similar to performance standards in FDA's regulations. Accordingly, FDA does not intend to consider whether firms that comply with the comparable IEC standards discussed in this guidance document also comply with performance standards in FDA's regulations. This draft guidance is not final nor is it in effect at this time.

    DATES:

    Submit either electronic or written comments on the draft guidance by March 20, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.

    ADDRESSES:

    You may submit comments on any guidance at any time as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

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

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

    Written/Paper Submissions

    Submit written/paper submissions as follows:

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

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

    Instructions: All submissions received must include the Docket No. FDA-2017-D-7011 for “Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed.3.1 (Laser Notice No. 56).” 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 10115(g)(5)).

    An electronic copy of the guidance document is available for download from the internet. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written requests for a single hard copy of the draft guidance document entitled “Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed.3.1 (Laser Notice No. 56)” to the Office of the Center Director, Guidance and Policy Development, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request.

    FOR FURTHER INFORMATION CONTACT:

    Patrick Hintz, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4228, Silver Spring, MD 20993-0002, 301-796-6927.

    SUPPLEMENTARY INFORMATION:

    I. Background

    FDA recognizes that the IEC is a global organization that prepares and publishes international standards for electrical, electronic, and related technologies, including laser products. This means that manufacturers distributing products in the United States and other countries might have to ensure conformance of their products with IEC standards as well as comply with FDA regulatory requirements. Complying with FDA regulations and conforming to the identified IEC standards may cause manufacturers to duplicate their efforts.

    FDA acknowledges the advantages of a universal set of device-specific criteria and requirements. Moreover, FDA believes that under the circumstances described in this guidance, conformance with certain IEC standards would provide adequate protection of the public health and safety for laser products similar to FDA's performance standards in §§ 1040.10 and 1040.11 (21 CFR 1040.10 and 1040.11). FDA eventually intends to amend its standards for laser products at §§ 1040.10 and 1040.11 to harmonize many of its requirements with those of the IEC because FDA acknowledges the advantages of one set of criteria and requirements worldwide.

    On June 24, 2007, FDA's Center for Devices and Radiological Health (CDRH) published a guidance entitled “Laser Products—Conformance with IEC 60825-1 and IEC 60601-2-22; Guidance for Industry and FDA Staff (Laser Notice No. 50)” (https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm094366.pdf). This draft guidance, when finalized, will not replace the recommendations provided in that 2007 guidance, and upon finalization of this guidance, manufacturers can follow either Laser Notice No. 50 or this guidance.

    II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on “Laser Products—Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed.3.1 (Laser Notice No. 56)”. 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 draft guidance may do so by downloading an electronic copy from the internet. A search capability for all CDRH guidance documents is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This guidance document is also available at https://www.regulations.gov. Persons unable to download an electronic copy of “Laser Products—Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed.3.1 (Laser Notice No. 56)” may send an email request to [email protected] to receive an electronic copy of the document. Please use the document number 1500024 to identify the guidance you are requesting.

    IV. 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 1002.10, 1010.2, 1010.3, 1040.10, and 1040.11 have been approved under OMB control number 0910-0025.

    Dated: January 12, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-00898 Filed 1-18-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-D-1309] Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of availability.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled “Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act.” One of the conditions to qualify for exemptions under section 503A of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), is that a drug product must be compounded by a licensed pharmacist or physician who does not compound regularly or in inordinate amounts any drug products that are essentially copies of a commercially available drug product. This guidance sets forth FDA policies regarding this provision of section 503A, including the terms “commercially available,” “essentially a copy of a commercially available drug product,” and “regularly or in inordinate amounts.”

    DATES:

    The announcement of the guidance is published in the Federal Register on January 19, 2018.

    ADDRESSES:

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

    Electronic Submissions

    Submit electronic comments in the following way:

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

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

    Written/Paper Submissions

    Submit written/paper submissions as follows:

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

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

    Instructions: All submissions received must include the Docket No. FDA-2016-D-1309 for “Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

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

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

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

    Submit written requests for single copies of this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document.

    FOR FURTHER INFORMATION CONTACT:

    Sara Rothman, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 5197, Silver Spring, MD 20993, 301-796-3110.

    SUPPLEMENTARY INFORMATION:

    I. Background

    FDA is announcing the availability of a final guidance for industry entitled “Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act.” Section 503A (21 U.S.C. 353a), added to the FD&C Act by the Food and Drug Administration Modernization Act of 1997, describes the conditions that must be satisfied for human drug products compounded by a licensed pharmacist in a State-licensed pharmacy or Federal facility, or by a licensed physician, to be exempt from the following three sections of the FD&C Act:

    • Section 501(a)(2)(B) (21 U.S.C. 351 (a)(2)(B)) (concerning current good manufacturing practice requirements);

    • Section 502(f)(1) (21 U.S.C. 352(f)(1)) (concerning the labeling of drugs with adequate directions for use); and

    • Section 505 (21 U.S.C. 355) (concerning the approval of drugs under new drug applications (NDAs) or abbreviated new drug applications (ANDAs)).

    One of the conditions that must be met for a compounded drug product to qualify for the exemptions under section 503A of the FD&C Act is that it must be compounded by a licensed pharmacist or a licensed physician that does not compound regularly or in inordinate amounts (as defined by the Secretary of Health and Human Services) any drug products that are essentially copies of a commercially available drug product (section 503A(b)(1)(D)).

    The statute further states that the term “essentially a copy of a commercially available drug product” does not include a drug product in which there is a change, made for an identified individual patient, which produces for that patient a significant difference, as determined by the prescribing practitioner, between the compounded drug and the comparable commercially available drug product (section 503A(b)(2) of the FD&C Act).

    This guidance sets forth FDA's policies concerning the “essentially a copy” provision under section 503A of the FD&C Act, including the terms “commercially available,” “essentially a copy of a commercially available drug product,” and “regularly or in inordinate amounts.”

    In the Federal Register of July 11, 2016 (81 FR 44881), FDA issued a notice announcing the availability of the draft version of this guidance. The comment period on the draft guidance ended on October 11, 2016. FDA received approximately 88 comments on the draft guidance. In response to received comments or on its own initiative, FDA made several changes. For example, in response to requests in comments for direction on records retention, FDA added a recommendation that compounders maintain the records described in the guidance for a period of at least 3 years. In addition, to address questions raised in comments, FDA clarified that the policies in this guidance apply to a compounded drug product without regard to the source(s) of the active pharmaceutical ingredient (API) in that product, for example, the policies would apply regardless of whether the compounder used an API that was purchased as an isolate, or if the compounder modified a finished drug product containing an API.

    FDA received comments on the draft guidance from hospital organizations regarding the potential implications of the proposed policies in the draft guidance for the preparation of compounded drugs used in in-patient settings. The final guidance notes that FDA is considering the applicability of the policies described in this guidance to hospitals and health systems. We recognize that this issue is of interest to many stakeholders and will convey our further thinking on the applicability of these policies to hospitals and health systems publicly with an opportunity for comment.

    This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). This guidance represents the current thinking of FDA on “Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.

    II. Paperwork Reduction Act of 1995

    This guidance contains collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520). Under the PRA, Federal Agencies must obtain approval from 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 and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, in the Federal Register of July 11, 2016, we gave interested persons 60 days to comment on the information collection provisions in the draft guidance (81 FR 44881).

    The information collection provisions in this guidance have been submitted to OMB for review as required by section 3507(d) of the PRA. These provisions are not in effect until they display a currently valid OMB control number. FDA will publish a notice in the Federal Register announcing OMB's decision regarding the information collection provisions in this guidance.

    III. Electronic Access

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

    Dated: January 16, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-00915 Filed 1-18-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-D-1309] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

    DATES:

    Fax written comments on the collection of information by February 20, 2018.

    ADDRESSES:

    To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202-395-7285, or emailed to [email protected] All comments should be identified with the OMB control number 0910—NEW and title “Guidance for Industry on Compounded Drug Products that are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act.” Also include the FDA docket number found in brackets in the heading of this document.

    FOR FURTHER INFORMATION CONTACT:

    Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, [email protected]

    SUPPLEMENTARY INFORMATION:

    In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

    Guidance for Industry on Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act OMB Control Number 0910—NEW

    This information collection supports the above captioned Agency guidance document. In the Federal Register of July 11, 2016 (81 FR 44881), FDA announced the availability of a draft guidance for industry entitled “Guidance for Industry on Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act,” and included an analysis of the associated information collection.

    Section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 353a) describes conditions that must be met in order for compounded drugs to receive exemptions from certain sections of the FD&C Act, including section 501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)) (concerning current good manufacturing practice for drugs); section 502(f)(1) (21 U.S.C. 352(f)(1)) (concerning the labeling of drugs with adequate directions for use) and section 505 (21 U.S.C. 355) (concerning the approval of human drug products under new drug applications or abbreviated new drug applications).

    One condition of section 503A is that a compounder “does not compound regularly or in inordinate amounts (as defined by the Secretary) any drug products that are essentially copies of a commercially available drug product” (section 503A(b)(1)(D)). However, for the purposes of this section, “essentially a copy of a commercially available drug product” does not include a drug product “in which there is a change, made for an identified individual patient, which produces for that patient a significant difference, as determined by the prescribing practitioner, between the compounded drug and the comparable commercially available drug product” (section 503A(b)(2)).

    The draft guidance states that if a compounder intends to rely on such a determination to establish that a compounded drug is not essentially a copy of a commercially available drug product, the compounder should ensure that the determination is documented on a prescription. If a prescription does not make clear that the prescriber made the determination required by section 503A(b)(2), or a compounded drug is substituted for the commercially available product at the pharmacy, the compounder may contact the prescriber and if the prescriber confirms it, make a notation on the prescription that the compounded product contains a change that makes a significant difference for the patient. The notations should be as specific as those described in this document, and the date of the conversation with the prescriber should be included on the prescription.

    In addition, if the drug was compounded because the approved product was not commercially available because it was on the FDA drug shortage list, the prescription or a notation on the prescription should note that it was on the drug shortage list and the date the list was checked.

    Finally, compounders under section 503A should maintain records of the frequency in which they have compounded drug products that are essentially copies of commercially available drug products and the number of prescriptions that they have filled for compounded drug products that are essentially copies of commercially available drug products to document that such compounding has not been done “regularly” or in “inordinate amounts.”

    FDA received 88 comments on the draft guidance, several of which raised issues pertaining to the information collection provisions in the draft guidance. The issues raised are addressed below.

    Issue One: One commenter proposed that any compounded drug with the same Active Pharmaceutical Ingredient (API) as a commercially available drug product should be considered to be “essentially a copy” of the commercially available drug product.

    FDA Response to Issue One: FDA has not made this proposed change. A compounded drug with the same API as a commercially available drug product may be very different from that commercially available drug product. For example, it may have a different route of administration and a substantially different strength. In such cases, a prescriber determination is not needed because the compounded drug would not be considered to be “essentially a copy” of the commercially available drug product, even if it had the same API.

    Issue Two: Several individuals submitted comments requesting the collection of additional information than what was proposed in the draft guidance.

    • One commenter requested that the medical record maintained by the prescriber should include additional scientific rationale for prescribing the compounded product.

    • Another commenter requested documentation to justify the use of a bulk drug substance to compound a product that could have been made starting with FDA-approved products.

    FDA Response to Issue Two: Regarding the first comment, this recommendation regarding what information a prescriber should maintain is outside the scope of this guidance. Regarding the second comment, the proposal is beyond the scope of the current guidance and we express no opinion on the proposed analysis and documentation.

    Issue Three: Several individuals submitted comments regarding collection of the prescriber determination in the hospital setting.

    • Some commenters noted the prescriber determination is not necessary in the hospital setting because pharmacists often determine when a compounded drug is needed for a patient and not the prescriber. For example, one commenter noted that hospitals may have standing policies that specify use of compounded drugs in certain scenarios.

    • Other commenters suggested use of a template or “blanket” prescriber determination statement when certain drugs are needed for a patient population on a consistent basis.

    • Another commenter noted that State scope of practice acts or hospital policy may prohibit pharmacists from writing in the patient chart or altering the electronic health record.

    FDA Response to Issue Three: FDA is considering the applicability of the policies described in this guidance to hospitals and health systems and intends to address these issues in separate guidance.

    Issue Four: Several individuals commented that it would be burdensome to document the prescriber determination, as well as to call a prescriber to document a prescriber determination when such determination is not evident on the original prescription. Individuals felt a prescriber determination should not be necessary in certain cases, such as when a prescription indicates a compounded drug.

    FDA Response to Issue Four: Section 503A(b)(2) provides that a compounded drug is not essentially a copy of a commercially available drug product if there is a change, made for an identified individual patient, which produces for that patient a significant difference, as determined by the prescribing practitioner, between the compounded drug and the comparable commercially available drug. If a prescription already documents the prescriber's determination of significant difference, there is no additional documentation burden for the compounder. However, if a prescription does not make clear that the prescriber made the determination required by section 503A(d)(2), or a compounded drug is substituted for the commercially available product at the pharmacy, the compounder may contact the prescriber, and if the prescriber confirms it, make a notation on the prescription that the compounded product contains a change that makes a significant difference for the patient. FDA estimates this contact will take 3 minutes and should not present significant burden. Maintaining prescription records that may include such notations should not present any additional burden, as FDA understands that maintaining records of prescriptions for compounded drug products is part of the usual course of the practice of compounding and selling drugs and is required by States' pharmacy laws and other State laws governing recordkeeping by health care professionals and health care facilities. Finally, FDA notes that calling a prescriber to document a prescriber determination of significant difference is not a requirement. For example, the compounder has the option of not filling a prescription with a compounded drug if a prescriber determination is not provided.

    Issue Five: One commenter stated that requiring a notation on the prescription that a compounded drug was on the drug shortage list when compounded, and the date the list was checked, would be overly burdensome.

    FDA Response to Issue Five: FDA does not believe this presents a significant burden, as a compounder that wants to rely on a drug shortage to establish that a compounded drug is not essentially a copy of a commercially available drug would need to check FDA's shortage website. Noting the date the list was checked is not onerous, and is necessary for FDA to verify compliance during inspections. FDA estimates this activity would take 2 minutes.

    Issue Six: One commenter requested clarity on how long records should be maintained; what specific information should be maintained; and when such records should be presented to FDA.

    FDA Response to Issue Six: FDA has revised the guidance to include a recommended duration of 3 years for maintaining records. The guidance describes the records that can be retained to demonstrate compliance. FDA may request to review such records during establishment inspections.

    FDA estimates the burden of this collection of information as follows:

    We estimate that annually a total of approximately 6,888 compounders (“number of respondents” in table 1, line 1) will consult a prescriber to determine whether he or she has made a determination that the compounded drug has a change that produces a significant difference for a patient as compared to the comparable commercially available drug, and that the compounders will document this determination on approximately 172,200 prescription orders for compounded drugs (“total annual disclosures” in table 1, line 1). We estimate that the consultation between the compounder and the prescriber and adding a notation to each prescription that does not already document this determination will take approximately 3 minutes per prescription order.

    In addition, we estimate that a total of approximately 6,888 compounders (“number of respondents” in table 1, line 2) will document this information on approximately 344,400 prescription orders for compounded drugs (“total annual disclosures” in table 1, line 2). We estimate that checking FDA's drug shortage list and documenting this information will take approximately 2 minutes per prescription order.

    We estimate that a total of approximately 3,444 compounders (“number of recordkeepers” in table 2) will keep approximately 165,312 records (“total annual records”). We estimate that maintaining the records will take approximately 2 minutes per record.

    Table 1—Estimated Annual Third Party Disclosure Burden 1 Type of reporting Number of
  • respondents
  • Number of
  • disclosures per
  • respondent
  • Total annual disclosures Average burden per disclosure Total hours
    Consultation between the compounder and prescriber and the notation on the prescription documenting the prescriber's determination of significant difference 6,888 50 344,400 0.05 (3 minutes) 17,220 Checking FDA's drug shortage list and documenting on the prescription that the drug is in shortage 6,888 50 344,400 0.03 (2 minutes) 10,332 Total 27,552 1 There are no capital costs or operating and maintenance costs associated with this collection of information.
    Table 2—Estimated Annual Recordkeeping Burden 1 Type of recordkeeping Number of recordkeepers Number of records per recordkeeper Total annual records Average burden per recordkeeping Total hours Records of frequency and number of prescriptions filled for compounded drugs that are essentially a copy 3,444 48 165,312 0.03 (2 minutes) 4,959 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: January 16, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-00917 Filed 1-18-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-0055] Gastrointestinal Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice; establishment of a public docket; request for comments.

    SUMMARY:

    The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Gastrointestinal Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

    DATES:

    The meeting will be held on March 8, 2018, from 8 a.m. to 5 p.m.

    ADDRESSES:

    FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-0002. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.

    FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2018-N-0055. The docket will close on March 7, 2018. Submit either electronic or written comments on this public meeting by March 7, 2018. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before March 7, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of March 7, 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.

    Comments received on or before February 22, 2018, will be provided to the committee. Comments received after that date will be taken into consideration by FDA.

    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-2018-N-0055 for “Gastrointestinal Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments.” Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

    • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” FDA 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 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 the 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:

    Jay R. Fajiculay, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001, Fax: 301-847-8533, email: [email protected], or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the FDA's website at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting.

    SUPPLEMENTARY INFORMATION:

    Agenda: The committee will discuss supplemental new drug application (sNDA) 203214 supplement 18, XELJANZ (tofacitinib) tablets, submitted by Pfizer Inc., proposed for the treatment of adult patients with moderately to severely active ulcerative colitis who have demonstrated an inadequate response, loss of response, or intolerance to corticosteroids, azathioprine, 6-mercaptopurine, or tumor necrosis factor inhibitor therapy.

    FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's website after the meeting. Background material is available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting link.

    Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before March 7, 2018. Oral presentations from the public will be scheduled between approximately 12:40 p.m. and 1:40 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before February 13, 2018. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by February 14, 2018.

    Persons attending FDA's advisory committee meetings are advised that FDA is not responsible for providing access to electrical outlets.

    For press inquiries, please contact the Office of Media Affairs at [email protected] or 301-796-4540.

    FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Jay R. Fajiculay (See, FOR FURTHER INFORMATION CONTACT) at least 7 days in advance of the meeting.

    FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct during advisory committee meetings.

    Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).

    Dated: January 10, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-00903 Filed 1-18-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-D-6969] Product Title and Initial U.S. Approval in Highlights for Human Prescription Drug and Biological Products—Content and Format; Draft Guidance for Industry; Availability AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of availability.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Product Title and Initial U.S. Approval in the Highlights of Prescribing Information for Human Prescription Drug and Biological Products—Content and Format.” The labeling regulations for human drug and biological products require that the Highlights of Prescribing Information (Highlights) contain a product title and the year of initial U.S. approval. This draft guidance provides recommendations on the content and format of the product title and initial U.S. approval to bring greater consistency to the presentation of these required elements and to help ensure these elements provide clear and useful information to the health care provider.

    DATES:

    Submit either electronic or written comments on the draft guidance by March 20, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.

    ADDRESSES:

    You may submit comments on any guidance at any time as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

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

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

    Written/Paper Submissions

    Submit written/paper submissions as follows:

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

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

    Instructions: All submissions received must include the Docket No. FDA-2017-D-6969 for “Product Title and Initial U.S. Approval in Highlights for Human Prescription Drug and Biological Products—Content and Format; Guidance for Industry; Availability.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

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

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

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

    Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building., 4th Floor, Silver Spring, MD 20993-0002, 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 requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

    FOR FURTHER INFORMATION CONTACT:

    Debra Beitzell, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm 6460, Silver Spring, MD 20993-0002, 301-796-0700; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.

    SUPPLEMENTARY INFORMATION:

    I. Background

    FDA is announcing the availability of a draft guidance for industry entitled “Product Title and Initial U.S. Approval in the Highlights of Prescribing Information for Human Prescription Drug and Biological Products—Content and Format.”

    On January 24, 2006, FDA published a final rule amending the requirements for the content and format of labeling for human prescription drug and biological products (71 FR 3922, January 24, 2006). This rule is known as the physician labeling rule because it addresses prescription drug labeling that is used by physicians and other health care providers. Under this rule, the prescribing information of new and more recently approved prescription drug and biological products contains the following three sections: Highlights, Full Prescribing Information: Contents, and Full Prescribing Information (§ 201.56(d)(1) (21 CFR 201.56(d)(1))).

    Highlights is required to contain the drug names (proprietary name and nonproprietary name (established name of the drug or, for biological products, the proper name)), dosage form, route of administration, and, if applicable, controlled substance symbol of the drug or biological product (§ 201.57(a)(2) (21 CFR 201.57(a)(2))). This set of information is referred to as the “product title” and follows the Highlights Limitation Statement. Highlights also must include the year of initial U.S. approval of the drug or biological product (§ 201.57(a)(3)). The initial U.S. approval must be placed immediately beneath the product title and is the four-digit year in which FDA initially approved the new molecular entity, new biological product, or new combination of active ingredients.

    This draft guidance provides recommendations on the content and format of the product title in Highlights. Recommended sources for product title terminology also are provided. Appendix A, “Dosage Form Terms for Use in Human Drug Product Labeling” and Appendix B, “Route of Administration Terms for Use in Human Drug Product Labeling” contain lists of recommended dosage form and route of administration terms, respectively, for use in the product title. This draft guidance contains recommendations for products with special nomenclature considerations, recommendations for what not to include in the product title, and implications for container and carton labeling.

    The draft guidance also provides recommendations on the content and format of the initial U.S. approval in Highlights. Items to consider when determining the year of initial U.S. approval are included and drug products requiring special consideration are described.

    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 the content and format of the product title and initial U.S. approval in Highlights for human prescription drug and biological products. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.

    II. The Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in §§ 201.56 and 201.57 have been approved under OMB control number 0910-0572.

    III. Electronic Access

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

    Dated: January 12, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-00899 Filed 1-18-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-D-6880] Material Threat Medical Countermeasure Priority Review Vouchers; Draft Guidance for Industry; Availability AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Material Threat Medical Countermeasure Priority Review Vouchers.” There is stakeholder interest in FDA's implementation of the provision of the 21st Century Cures Act (Cures Act) that adds a new section to the Federal Food, Drug, and Cosmetic Act (FD&C Act) on priority review vouchers for material threat medical countermeasure applications. This new section of the FD&C Act makes provisions for awarding priority review vouchers for use with applications to sponsors of material threat medical countermeasure applications that meet the criteria specified by the FD&C Act. This draft guidance explains to internal and external stakeholders how FDA intends to implement the provisions of the new section of the FD&C Act.

    DATES:

    Submit either electronic or written comments on the draft guidance by March 20, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.

    ADDRESSES:

    You may submit comments on any guidance at any time as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

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

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

    Written/Paper Submissions

    Submit written/paper submissions as follows:

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

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

    Instructions: All submissions received must include the Docket No. FDA-2017-D-6880 for “Material Threat Medical Countermeasure Priority Review Vouchers; Draft Guidance for Industry; Availability.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the office of 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 Office of Counterterrorism and Emerging Threats, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4343, Silver Spring, MD 20993-0002, 301-796-8510. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document.

    FOR FURTHER INFORMATION CONTACT:

    Carol Drew, Office of Counterterrorism and Emerging Threats, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4320, Silver Spring, MD 20993-0002, 301-796-8510 (this is not a toll free number).

    SUPPLEMENTARY INFORMATION:

    I. Background

    FDA is announcing the availability of a draft guidance for industry entitled, “Material Threat Medical Countermeasure Priority Review Vouchers.” Section 3086 of the Cures Act adds new section 565A to the FD&C Act. Section 565A of the FD&C Act (21 U.S.C. 360bbb-4a) was designed to encourage development of medical countermeasures by offering additional incentives for obtaining approval of new drug or biological medical products for the prevention and treatment of harm from a biological, chemical, radiological, or nuclear agent identified as a material threat. Under section 565A of the FD&C Act, a sponsor of a human drug application for a material threat medical countermeasure application may be eligible for a voucher that can be used to obtain a priority review for any application submitted under section 505(b)(1) of the FD&C Act (21 U.S.C. 355(b)(1)) or section 351 of the Public Health Service (PHS) Act (42 U.S.C. 262). The draft guidance also provides information on using the priority review vouchers and on transferring priority review vouchers to other sponsors.

    This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance represents the current thinking of FDA on obtaining a material threat medical countermeasure priority review voucher. It does not create or confer any rights for or on any person and does not operate to bind 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

    Under the Paperwork Reduction Act of 1995 (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 that 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 for each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing this notice of the proposed collection of information set forth in this document.

    With respect to the collection of information associated with this draft guidance, FDA invites comment on the following topics: (1) Whether the proposed information collected is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimated burden of the proposed information collected, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information collected; and (4) ways to minimize the burden of information collected on the respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

    Under the draft guidance, sponsors of certain medical countermeasure product applications submitted under section 505(b)(1) of the FD&C Act and section 351 of the PHS Act may request a priority review voucher. Based on inquiries FDA has received on section 565A and related discussions with sponsors, we estimate that we will receive annually approximately 2 requests from 2 sponsors, and that each request will take approximately 8 hours to prepare and submit to FDA.

    The draft guidance also states that sponsors should notify FDA of their intent to use a priority review voucher, including the date on which the sponsor intends to submit the application, at least 90 days before use. We estimate that we will receive annually approximately 2 notifications of intent to use a voucher from 2 sponsors, and that each notification will take approximately 8 hours to prepare and submit to FDA. The draft guidance also permits the transfer of a priority review voucher from one sponsor to another, and states that each transfer should be documented with a letter of transfer. We estimate that we will receive approximately 1 letter indicating the transfer of a voucher from 1.5 application holders, and 1 letter acknowledging the receipt of a transferred voucher from 1.5 new voucher owners acknowledging the transfer, and that it will take approximately 8 hours to prepare and submit each letter to FDA.

    FDA estimates the burden of this collection of information as follows:

    Table 1—Estimated Annual Reporting Burden 1 Reporting under Section 3086 of the Cures Act Number of respondents Number of
  • responses per
  • respondent
  • Total
  • responses
  • Hours per
  • response
  • Total
  • hours
  • Priority review voucher request 2 1 2 8 16 Notifications of intent to use a voucher 2 1 2 8 16 Letters indicating the transfer of a voucher 1.5 1 1.5 8 12 Letters acknowledging the receipt of a transferred voucher 1.5 1 1.5 8 12 Total 56 1 There are no capital costs or operating and maintenance costs associated with this collection of information.
    III. Electronic Access

    Persons with access to the internet may obtain the draft guidance at https://www.fda.gov/RegulatoryInformation/Guidances/default.htm, https://www.regulations.gov, or https://www.fda.gov/medicalcountermeasures.

    Dated: January 11, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-00900 Filed 1-17-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Information Collection Request Title: National Practitioner Data Bank for Adverse Information on Physicians and Other Health Care Practitioners—OMB No. 0915-0126—Revision AGENCY:

    Health Resources and Services Administration (HRSA), Department of Health and Human Services.

    ACTION:

    Notice.

    SUMMARY:

    In compliance with the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.

    DATES:

    Comments on this ICR should be received no later than February 20, 2018.

    ADDRESSES:

    Submit your comments, including the ICR Title, to the desk officer for HRSA, either by email to [email protected] or by fax to 202-395-5806.

    FOR FURTHER INFORMATION CONTACT:

    To request a copy of the clearance requests submitted to OMB for review, email Lisa Wright-Solomon, the HRSA Information Collection Clearance Officer, at [email protected] or call (301) 443-1984.

    SUPPLEMENTARY INFORMATION:

    When submitting comments or requesting information, please include the information request collection title for reference, in compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995.

    Information Collection Request Title: National Practitioner Data Bank for Adverse Information on Physicians and Other Health Care Practitioners—45 CFR part 60 Regulations and Forms, OMB No. 0915-0126—Revision.

    Abstract: This is a request for a revision of OMB approval of the information collection contained in regulations found at 45 CFR part 60 governing the National Practitioner Data Bank (NPDB) and the forms to be used in registering with, reporting information to, and requesting information from the NPDB. Administrative forms are also included to aid in monitoring compliance with Federal reporting and querying requirements. Responsibility for NPDB implementation and operation resides in HRSA's Bureau of Health Workforce.

    The intent of the NPDB is to improve the quality of health care by encouraging hospitals, State licensing boards, professional societies, and other entities providing health care services to identify and discipline those who engage in unprofessional behavior, and to restrict the ability of incompetent health care practitioners, providers, or suppliers to move from State to State without disclosure of previous damaging or incompetent performance. It also serves as a fraud and abuse clearinghouse for the reporting and disclosing of certain final adverse actions (excluding settlements in which no findings of liability have been made) taken against health care practitioners, providers, or suppliers by health plans, Federal agencies, and State agencies.

    The reporting forms, request for information forms (query forms), and administrative forms (used to monitor compliance) are accessed, completed, and submitted to the NPDB electronically through the NPDB website at https://www.npdb.hrsa.gov/. All reporting and querying is performed through the secure portal of this website. This revision proposes changes to eliminate redundant and unnecessary forms, improve user error recovery, and improve overall data integrity. There is no change to the average burden per response. The total estimated number of respondents has increased from 5 million in 2015 to over 6 million in 2017, primarily attributable to increases in use of the “One-Time Query for an Individual” and “Continuous Query” forms. The increase in total respondents resulted in an estimated increase of approximately 47,000 total burden hours.

    Need and Proposed Use of the Information: The NPDB acts primarily as a flagging system; its principal purpose is to facilitate comprehensive review of practitioners' professional credentials and background. Information is collected from, and disseminated to, eligible entities (entities that are entitled to query and/or report to the NPDB as authorized in Title 45 CFR part 60) on the following: (1) Medical malpractice payments, (2) licensure actions taken by Boards of Medical Examiners, (3) State licensure and certification actions, (4) Federal licensure and certification actions, (5) negative actions or findings taken by peer review organizations or private accreditation entities, (6) adverse actions taken against clinical privileges, (7) Federal or State criminal convictions related to the delivery of a health care item or service, (8) civil judgments related to the delivery of a health care item or service, (9) exclusions from participation in Federal or State health care programs, and (10) other adjudicated actions or decisions. It is intended that NPDB information should be considered with other relevant information in evaluating credentials of health care practitioners, providers, and suppliers.

    Likely Respondents: Eligible entities or individuals that are entitled to query and/or report to the NPDB as authorized in regulations found at 45 CFR part 60.

    Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose, or provide the information requested. This includes the time needed to review instructions; to develop, acquire, install, and utilize technology and systems for the purpose of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information; to search data sources; to complete and review the collection of information; and to transmit or otherwise disclose the information. The total annual burden hours estimated for this ICR are summarized in the table below.

    Total Estimated Annualized Burden—Hours Regulation citation Form name Number of
  • respondents
  • Responses per
  • respondent
  • Total
  • responses
  • Average
  • burden per
  • response
  • (in hours)
  • Total burden hours
    § 60.6: Reporting errors, omissions, revisions or whether an action is on appeal Correction, Revision to Action, Correction of Revision to Action, Void, Notice of Appeal (manual) 11,114 1 11,114 .25 2,779 Correction, Revision to Action, Correction of Revision to Action, Void, Notice of Appeal (automated) 17,966 1 17,966 .0003 6 § 60.7: Reporting medical malpractice payments Medical Malpractice Payment (manual) 11,993 1 11,993 .75 8,995 Medical Malpractice Payment (automated) 242 1 242 .0003 1 § 60.8: Reporting licensure actions taken by Boards of Medical Examiners
  • &
  • § 60.9: Reporting licensure and certification actions taken by States.
  • State Licensure (manual)
  • State Licensure (automated)
  • 19,160
  • 25,980
  • 1
  • 1
  • 19,160
  • 25,980
  • .75
  • .0003
  • 14,370
  • 8
  • § 60.10: Reporting Federal licensure and certification actions DEA/Federal Licensure 698 1 698 .75 524 § 60.11: Reporting negative actions or findings taken by peer review organizations or private accreditation entities Peer Review Organization
  • Accreditation
  • 10
  • 10
  • 1
  • 1
  • 10
  • 10
  • .75
  • .75
  • 8
  • 8
  • § 60.12: Reporting adverse actions taken against clinical privileges Title IV Clinical Privileges Actions
  • Professional Society
  • 698
  • 49
  • 1
  • 1
  • 698
  • 49
  • .75
  • 524
  • 37
  • § 60.13: Reporting Federal or State criminal convictions related to the delivery of a health care item or service Criminal Conviction (Guilty Plea or Trial) (manual)
  • Criminal Conviction (Guilty Plea or Trial) (automated)
  • Deferred Conviction or Pre-Trial Diversion
  • 1,140
  • 688
  • 54
  • 1
  • 1
  • 1
  • 1,140
  • 688
  • 54
  • .75
  • .0003
  • .75
  • 855
  • 1
  • 41
  • Nolo Contendere (No Contest) Plea 85 1 85 .75 64 Injunction 10 1 10 .75 8 § 60.14: Reporting civil judgments related to the delivery of a health care item or service Civil Judgment 10 1 10 .75 8 § 60.15: Reporting exclusions from participation in Federal or State health care programs Exclusion/Debarment (manual)
  • Exclusion/Debarment (automated)
  • 1,624
  • 3,180
  • 1
  • 1
  • 1,624
  • 3,180
  • .75
  • .0003
  • 1,218
  • 1
  • § 60.16: Reporting other adjudicated actions or decisions Government Administrative
  • Health Plan Action
  • 2,062
  • 335
  • 1
  • 1
  • 2,062
  • 335
  • .75
  • .75
  • 1,547
  • 252
  • § 60.18 Requesting Information from the NPDB One-Time Query for an Individual (manual) 2,054,381 1 2,054,381 .08 164,351 One-Time Query for an Individual (automated) 2,813,341 1 2,813,341 .0003 844 One-Time Query for an Organization (manual) 39,695 1 39,695 .08 3,176 One-Time Query for an Organization (automated) 10,201 1 10,201 .0003 4 Self-Query on an Individual 131,481 1 131,481 .42 55,223 Self-Query on an Organization 1,545 1 1,545 .42 649 Continuous Query (manual) 643,860 1 643,860 .08 51,509 Continuous Query (automated) 226,838 1 226,838 .0003 69 § 60.21: How to dispute the accuracy of NPDB information Subject Statement and Dispute
  • Request for Dispute Resolution
  • 3,547
  • 99
  • 1
  • 1
  • 3,547
  • 99
  • .75
  • 8
  • 2,661
  • 792
  • Administrative Entity Registration (Initial) 1,073 1 1,073 1 1,073 Entity Registration (Renewal & Update) 14,060 1 14,060 .25 3,515 Entity Profile 9,000 1 9,000 .25 2,250 Licensing Board Data Request 146 1 146 10.5 1,533 Licensing Board Attestation 301 1 301 1 301 Corrective Action Plan 10 1 10 .08 1 Reconciling Missing Actions 7,981 1 7,981 0.8 6,385 Agent Registration (Initial) 85 1 85 1 85 Agent Registration (Renewal) 278 1 278 .08 23 Electronic Transfer of Funds (EFT) Authorization 654 1 654 .08 53 Authorized Agent Designation 213 1 213 .25 54 Account Discrepancy 10 1 10 .25 3 New Administrator Request 3,016 1 3,016 .08 242 Query Credit Purchase 789 1 789 .08 64 Educational Request 10 1 10 .08 1 Account Balance Transfer 10 1 10 .08 1 Missing Report Form 29 1 29 .08 3 Total 6,059,761 6,059,761 326,120

    HRSA specifically requests comments on (1) the necessity and utility of the proposed information collection for the proper performance of the agency's functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

    Amy McNulty, Acting Director, Division of the Executive Secretariat.
    [FR Doc. 2018-00825 Filed 1-18-18; 8:45 am] BILLING CODE 4165-15-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment AGENCY:

    Health Resources and Service Administration (HRSA), Department of Health and Human Services (HHS).

    ACTION:

    Notice of meeting.

    SUMMARY:

    In accordance with the Federal Advisory Committee Act, this notice announces that the Centers for Disease Control and Prevention (CDC)/Health Resources and Services Administration (HRSA) Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment will hold a public meeting.

    DATES:

    February 22, 2018, 2:00 p.m. to 4:00 p.m. ET.

    ADDRESSES:

    This teleconference meeting will accommodate up to 100 attendees. Parties may access the teleconference by dialing 888-989-6421 and using participant code 9874492. Participants should call and connect 15-minutes prior to the start of the meeting.

    FOR FURTHER INFORMATION CONTACT:

    Anyone requesting information regarding the CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment should contact CDR Holly Berilla, Senior Public Health Analyst, Division of Policy and Data (DPD), HIV/AIDS Bureau (HAB), HRSA, in one of three ways: (1) Mail a request to CDR Holly Berilla, Senior Public Health Analyst, HRSA/HAB/DPD, 5600 Fishers Lane, 09N156, Rockville, Maryland 20857; (2) call 301-443-9965; or (3) send an email to [email protected]

    SUPPLEMENTARY INFORMATION:

    The CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment was established under Section 222 of the Public Health Service (PHS) Act, [42 U.S.C. Section 217a], as amended.

    The purpose of the CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment is to advise the Secretary, HHS; the Director, CDC; and the Administrator, HRSA regarding objectives, strategies, policies, and priorities for HIV, viral hepatitis, and other STDs; prevention and treatment efforts including surveillance of HIV infection, AIDS, viral hepatitis, and other STDs, and related behaviors; epidemiologic, behavioral, health services, and laboratory research on HIV, viral hepatitis, and other STDs; identification of policy issues related to HIV/viral hepatitis/STD professional eduction, patient healthcare delivery, and prevention services; Agency policies about prevention of HIV, viral hepatitis and other STDs; treatment, healthcare delivery, and research and training; strategic issues influencing the ability of CDC and HRSA to fulfill their missions of providing prevention and treatment services; programmatic efforts to prevent and treat HIV, viral hepatitis, and other STDs; and support to the Agencies in their developoment of responses to emerging health needs related to HIV, viral hepatitis, and other STDs. Information about the Committee and the meeting agenda is available by contacting CDR Holly Berilla at the contact information above.

    During the meeting, the CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment will discuss workgroup reports and updates, information regarding the National Ryan White HIV/AIDS Program Conference, and Committee business-related items. Agenda items are subject to change as priorities dictate.

    Due to the nature and time limitations of the meeting, members of the public will not have an opportunity to provide oral comments, although written comments may be submitted to CDR Holly Berilla at the contact information listed above at least 10 days prior to the meeting. Individuals who need special assistance should notify CDR Holly Berilla at the contact information listed above at least 10 days prior to the meeting.

    Amy McNulty, Acting Director, Division of the Executive Secretariat.
    [FR Doc. 2018-00824 Filed 1-18-18; 8:45 am] BILLING CODE 4165-15-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary Statement of Organization, Functions, and Delegations of Authority AGENCY:

    Office for Civil Rights, Office of the Secretary, HHS.

    SUMMARY:

    This notice establishes the Conscience and Religious Freedom Division in the Office for Civil Rights of the Department of Health and Human Services.

    SUPPLEMENTARY INFORMATION:

    In accordance with Executive Order 13798 Promoting Free Speech and Religious Liberty (May 4, 2017), 82 FR 21675, and the Attorney General's Guidance on Federal Law Protections for Religious Liberty (October 6, 2017), Part A, Office of the Secretary, Statement of Organization, Functions, and Delegations of Authority for the Department of Health and Human Services (HHS), as last amended at 81 FR 95622 (December 28, 2016), is being amended at Chapter AT, Office for Civil Rights (OCR) to reflect the restructuring of OCR as follows:

    I. Under Chapter AT, Office for Civil Rights (OCR), in the outline section at the beginning of the Chapter that reads: “AT.00 Mission AT.10 Organization AT.20 Functions” II. Under Chapter AT, Office for Civil Rights (OCR), delete “Section AT.00 Mission” in its entirety and replace with the following: “AT.00 Mission

    OCR, a Staff Division of the U.S. Department of Health and Human Services (HHS), ensures that individuals receiving services from HHS-funded programs are not subject to unlawful discrimination; that individuals and entities are free from coercion and can exercise their conscience and religious freedom rights; and that people can trust the privacy, security, and availability of their health information. By rooting out invidious discrimination and removing unlawful barriers to HHS-funded services, OCR carries out the HHS mission of improving the health and well-being of all Americans and providing essential human services. By ensuring individuals and institutions can exercise their conscience and religious freedom rights, OCR furthers justice and tolerance in a pluralistic society. By promoting the right to access health information and protecting the privacy and security of this information, OCR helps empower people's health care decision-making and helps ensure the integrity of the health care system and thereby promotes better health outcomes for the nation.

    OCR accomplishes this by:

    • Enforcing laws, investigating complaints, conducting compliance reviews, promulgating regulations, developing policy, providing technical assistance, and engaging in public education and outreach to ensure understanding of and compliance with all the laws OCR has authority over;

    • Ensuring that recipients of HHS federal financial assistance comply with federal civil rights laws that prohibit discrimination on the bases of race, color, national origin, disability, age, sex, and religion;

    • Ensuring that federal agencies, state and local governments, health care providers, health plans, and others comply with federal laws guaranteeing the free exercise of religious beliefs and moral convictions and the right to be free from coercion in HHS-conducted or funded programs; and

    • Ensuring the practices of health care providers, health plans, health care clearinghouses, and their business associates adhere to federal privacy, security, and breach notification regulations under the Health Insurance Portability and Accountability Act (HIPAA) through the investigation of complaints, self-reports of breaches, compliance reviews, and audits.”

    III. Under Chapter AT, Office for Civil Rights (OCR), delete “Section AT.10 Organization” in its entirety and replace with: “AT.10 Organization A. Office of the Director (AT) B. Operations and Resources Division (ATA) C. Civil Rights Division (ATB) D. Health Information Privacy Division (ATC) E. Conscience and Religious Freedom Division (ATD)” IV. Under Chapter AT, Office for Civil Rights (OCR), Section “AT.20 Functions” delete subsection “A. Office of the Director (AT)” in its entirety and replace with the following: A. Office of the Director (AT). The Director is the Department's chief officer and adviser to the Secretary concerning implementation of, compliance with, and enforcement of civil rights and conscience and religious freedom laws applicable to HHS-funded or conducted programs or activities, and privacy, security, and breach notification rules under HIPAA. The Director provides leadership, priorities, guidance, and supervision to OCR and is responsible for its overall policy, programs, and operations. The Director is also responsible for representing the Secretary and the Department, in coordination and consultation with the Assistant Secretary for Legislation, before Congress and the Executive Office of the President on matters relating to civil rights, conscience and religious freedom, and health information privacy and for liaising with other federal departments and agencies responsible for similar or related matters.” V. Under Chapter AT, Office for Civil Rights (OCR), Section “AT.20 Functions” at subsection “B. Operations and Resources Division (ATA)” add “, conscience and religious freedom,” after “ORD is responsible for responding to stakeholder calls and triaging civil rights.” VI. Under Chapter AT, Office for Civil Rights (OCR), Section “AT.20 Functions” at subsection “C. Civil Rights Division (ATB),” delete “original” after “on the basis of race, color, national” and replace with “origin” and delete “; the Division also enforces provider conscience laws” after “sex, disability, and age.” VII. Under Chapter AT, Office for Civil Rights (OCR), Section “AT.20 Functions” add a new subsection E as follows: AT.20 Functions “E. Conscience and Religious Freedom Division (ATD). The Conscience and Religious Freedom Division (CRFD) is headed by the Deputy Director for Conscience and Religious Freedom, who reports to the Director. The CRFD is responsible for OCR's national conscience and religious freedom program, including enforcement of and compliance with laws protecting conscience and the free exercise of religion and prohibiting coercion and religious discrimination. These laws include, but are not limited to, the Church Amendments (42 U.S.C. 300a-7); the Coats-Snowe Amendment (42 U.S.C. 238n); the Weldon Amendment (e.g., Pub. L. 115-31, Div. H, § 507(d) (2017)); Sections 1303(b)(4) and 1553 of the Affordable Care Act (42 U.S.C. 18023(b)(4) and 18113, respectively); the Religious Freedom Restoration Act (42 U.S.C. 2000bb et seq.); the employment religious nondiscrimination provisions in the Public Telecommunications Financing Act of 1978 (47 U.S.C. 398(b)) and the religious nondiscrimination provisions in various block grant authorizing statutes. The CRFD conducts OCR's nationwide enforcement and compliance activities including investigating and developing cases; negotiating case resolution agreements; developing enforcement and litigation strategies; promulgating regulations, policies, and guidance; and conducting compliance reviews of covered entities and HHS Operating and Staff Divisions, in consultation with the HHS Center for Faith-Based and Neighborhood Partnerships, as appropriate. The CRFD also identifies and designs conscience and religious freedom-specific training programs for Departmental staff, provides subject-matter expertise for public education and outreach activities to stakeholders nationwide, and liaises with, and provides conscience and religious freedom technical assistance and advisory services to, HHS Operating and Staff Divisions, national advocacy, beneficiary, and provider groups, religious organizations, faith-based organizations, and for profit and non-profit organizations, state and local governments, and to other federal departments and agencies, including by serving on intra- and interagency workgroups.” VIII. Pending further delegations, directives, or orders by the Secretary or the OCR Director, all delegations and redelegations of authority to positions of the affected organizations in effect prior to the date of this notice shall continue in effect in them or their successors, provided they are consistent with this reorganization. Dated: December 7, 2017. Eric D. Hargan, Acting Secretary, Department of Health and Human Services.
    [FR Doc. 2018-00820 Filed 1-18-18; 8:45 am] BILLING CODE 4153-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary Office for Civil Rights; Statement of Delegation

    In accordance with Executive Order 13798 Promoting Free Speech and Religious Liberty (May 4, 2017), 82 FR 21675, and the Attorney General's Guidance on Federal Law Protections for Religious Liberty (October 6, 2017), notice is hereby given that I have delegated to the Director of the Office for Civil Rights (OCR), or his or her successor, authority over implementation of and compliance with the Religious Freedom Restoration Act (RFRA), 42 U.S.C. 2000bb et seq., relating to programs or activities funded, conducted, or administered by the Department.

    Pursuant to this delegation, the OCR Director shall have the authority to:

    (1) Accept and investigate complaints filed by individuals or entities alleging a failure by any departmental component to comply with RFRA;

    (2) conduct RFRA compliance reviews of departmental programs or activities;

    (3) provide technical assistance to departmental components regarding RFRA compliance;

    (4) evaluate the effectiveness of RFRA complaint processing by OCR and provide reports to appropriate oversight organizations; and

    (5) initiate such other actions as may be necessary to facilitate and ensure compliance with RFRA.

    This authority may be redelegated. If the OCR Director chooses to redelegate this authority, the OCR Director will maintain primary responsibility and accountability for implementation of this section. This delegation is effective upon date of signature. I hereby affirm and ratify any actions taken by the Director of OCR or subordinates which involved the exercise of the authorities delegated herein prior to the effective day of this delegation.

    Dated: December 7, 2017. Eric D. Hargan, Acting Secretary, Department of Health and Human Services.
    [FR Doc. 2018-00816 Filed 1-18-18; 8:45 am] BILLING CODE 4153-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary Office for Civil Rights; Statement of Delegation

    Notice is hereby given that I have delegated to the Director of the Office for Civil Rights, or his or her successor, the authorities vested in the Secretary concerning enforcement of and compliance with Section 1303(b)(4) of the Patient Protection and Affordable Care Act, 42 U.S.C. 18023(b)(4). This delegation transfers, but only for the authorities pursuant to Section 1303(b)(4) and not for other authorities under Section 1303, the previous delegation to the Administrator, Centers for Medicare & Medicaid Services, or his or her successor, noticed at 76 FR 53903 (Aug. 30, 2011).

    Pursuant to this delegation, the OCR Director shall have the authority to:

    (1) Accept and investigate complaints filed by individuals or entities alleging a failure to comply with Section 1303(b)(4);

    (2) conduct Section 1303(b)(4) compliance reviews;

    (3) provide technical assistance to departmental components and qualified health plans regarding Section 1303(b)(4) compliance;

    (4) evaluate the effectiveness of subsection 1303(b)(4) complaint processing by OCR and provide reports to appropriate oversight organizations; and

    (5) initiate such other actions as may be necessary to facilitate and ensure compliance with Section 1303(b)(4).

    This authority may be redelegated. If the OCR Director chooses to redelegate this authority, the OCR Director will maintain primary responsibility and accountability for implementation of this section. This delegation is effective upon date of signature. I hereby affirm and ratify any actions taken by the Director of OCR or subordinates which involved the exercise of the authorities delegated herein prior to the effective day of this delegation.

    Dated: December 7, 2017. Eric D. Hargan, Acting Secretary, Department of Health and Human Services.
    [FR Doc. 2018-00818 Filed 1-18-18; 8:45 am] BILLING CODE 4153-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.

    The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: Biobehavioral and Behavioral Processes Integrated Review Group; Cognition and Perception Study Section.

    Date: February 8-9, 2018.

    Time: 8:00 a.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Embassy Suites Baltimore, Inner Harbor, 222 St. Paul Place, Baltimore, MD 21202.

    Contact Person: Andrea B. Kelly, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3184, MSC 7770, Bethesda, MD 20892, (301) 455-1761, [email protected]

    Name of Committee: Biobehavioral and Behavioral Processes Integrated Review Group; Adult Psychopathology and Disorders of Aging Study Section.

    Date: February 12-13, 2018.

    Time: 8:30 a.m. to 2:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Ritz-Carlton Hotel at Pentagon City, 1250 South Hayes Street, Arlington, VA 22202.

    Contact Person: Serena Chu, Ph.D., Scientific Review Officer, BBBP IRG, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3178, MSC 7848, Bethesda, MD 20892, (301) 500-5829, [email protected]

    Name of Committee: Endocrinology, Metabolism, Nutrition and Reproductive Sciences Integrated Review Group; Cellular Aspects of Diabetes and Obesity Study Section.

    Date: February 13-14, 2018.

    Time: 8:00 a.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Ritz-Carlton Hotel, 1700 Tysons Boulevard, McLean, VA 22102.

    Contact Person: Antonello Pileggi, MD, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institute of Heath, 6701 Rockledge Drive, Room 6166, Bethesda, MD 20892-7892, (301) 402-6297, [email protected]

    Name of Committee: Brain Disorders and Clinical Neuroscience Integrated Review Group; Clinical Neuroscience and Neurodegeneration Study Section.

    Date: February 13-14, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Hotel Zoe, 425 North Point Street, San Francisco, CA 94133.

    Contact Person: Alessandra C. Rovescalli, Ph.D., Scientific Review Officer, National Institutes of Health, Center for Scientific Review, 6701 Rockledge Drive, Rm. 5205, MSC 7846, Bethesda, MD 20892, (301) 435-1021, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Language and Communication.

    Date: February 13, 2018.

    Time: 8:30 a.m. to 9:00 a.m.

    Agenda: To review and evaluate grant applications.

    Place: Villa Florence Hotel, 225 Powell Street, San Francisco, CA 94102.

    Contact Person: Unja Hayes, Ph.D., Scientific Review Officer, National Institutes of Health, Center for Scientific Review, 6701 Rockledge Drive, Bethesda, MD 20892, 301-827-6830, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Cellular Aspects of Diabetes and Obesity.

    Date: February 13, 2018.

    Time: 1:00 p.m. to 2:30 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Ritz-Carlton Hotel, 1700 Tysons Boulevard, McLean, VA 22102.

    Contact Person: Elaine Sierra-Rivera, Ph.D., Scientific Review Officer, EMNR IRG, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6182, MSC 7892, Bethesda, MD 20892, 301 435-2514, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; PARS: Development of Appropriate Pediatric Formulations and Pediatric Drug Delivery Systems.

    Date: February 14, 2018.

    Time: 1:00 p.m. to 3:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call).

    Contact Person: Paek-Gyu Lee, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4201, MSC 7812, Bethesda, MD 20892, (301) 613-2064, [email protected]

    Name of Committee: Biological Chemistry and Macromolecular Biophysics Integrated Review Group; Macromolecular Structure and Function B Study Section.

    Date: February 15, 2018.

    Time: 8:00 a.m. to 8:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: The Westin St. Francis, 335 Powell Street, San Francisco, CA 94102.

    Contact Person: C-L Albert Wang, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4146, MSC 7806, Bethesda, MD 20892, 301-435-1016, [email protected]

    Name of Committee: Biobehavioral and Behavioral Processes Integrated Review Group; Biobehavioral Regulation, Learning and Ethology Study Section.

    Date: February 15-16, 2018.

    Time: 8:00 a.m. to 2:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: The William F. Bolger Center, 9600 Newbridge Drive, Potomac, MD 20854.

    Contact Person: Unja Hayes, Ph.D., Scientific Review Officer, National Institutes of Health, Center for Scientific Review, 6701 Rockledge Drive, Bethesda, MD 20892, 301-827-6830, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Somatosensory and Pain Systems.

    Date: February 15-16, 2018.

    Time: 8:00 a.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Hilton Long Beach and Executive Center, 701 West Ocean Boulevard, Long Beach, CA 90831.

    Contact Person: M. Catherine Bennett, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5182, MSC 7846, Bethesda, MD 20892, 301-435-1766, [email protected]

    Name of Committee: Biobehavioral and Behavioral Processes Integrated Review Group; Motor Function, Speech and Rehabilitation Study Section.

    Date: February 16, 2018.

    Time: 8:00 a.m. to 8:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Renaissance Long Beach Hotel, 111 East Ocean Blvd., Long Beach, CA 90802.

    Contact Person: Biao Tian, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3166, MSC 7848, Bethesda, MD 20892, 301-402-4411, [email protected]

    (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893, National Institutes of Health, HHS)
    Dated: January 11, 2018. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-00860 Filed 1-18-18; 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; Amended Notice of Meeting

    Notice is hereby given of a change in the meeting of the National Advisory Council on Alcohol Abuse and Alcoholism, February 08, 2018, 09:00 a.m. to February 08, 2018, 03:15 p.m., National Institutes of Health, National Institute on Alcohol Abuse and Alcoholism, 5635 Fishers Lane, Terrace Conference Rooms, Bethesda, MD 20892 which was published in the Federal Register on December 15, 2017, 82 FR 59629.

    The meeting notice is amended to change the ending time of the closed session to 10:15 a.m. and the start time of the open session to 10:15 a.m. on February 08, 2018. The meeting is partially closed to the public.

    Dated: January 9, 2018. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-00864 Filed 1-18-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.

    The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: Immunology Integrated Review Group; Transplantation, Tolerance, and Tumor Immunology Study Section.

    Date: February 8-9, 2018.

    Time: 8:00 a.m. to 2:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Holiday Inn San Francisco Fisherman's Wharf, 1300 Columbus Avenue, San Francisco, CA 94133.

    Contact Person: Jin Huang, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4199, MSC 7812, Bethesda, MD 20892, 301-435-1230, [email protected].

    Name of Committee: Endocrinology, Metabolism, Nutrition and Reproductive Sciences Integrated Review Group; Molecular and Cellular Endocrinology Study Section.

    Date: February 8-9, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Ritz-Carlton Hotel at Pentagon City, 1250 South Hayes Street, Arlington, VA 22202.

    Contact Person: Liliana Norma Berti-Mattera, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, RM 4215, Bethesda, MD 20892, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Nursing and Related Clinical Sciences.

    Date: February 8-9, 2018.

    Time: 8:00 a.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814.

    Contact Person: Martha L Hare, Ph.D., RN, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3154, Bethesda, MD 20892, (301) 451-8504, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR Panel: Biophysical and Biomechanical Aspects of Embryonic Development.

    Date: February 14, 2018.

    Time: 7:00 a.m. to 1:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Sir Francis Drake Hotel, 450 Powell Street at Sutter, San Francisco, CA 94102.

    Contact Person: Thomas Beres, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Rm. 5201, MSC 7840, Bethesda, MD 20892, 301-435-1175, [email protected].

    Name of Committee: Brain Disorders and Clinical Neuroscience Integrated Review Group; Chronic Dysfunction and Integrative Neurodegeneration Study Section.

    Date: February 15-16, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: New Orleans Marriott, 555 Canal Street, New Orleans, LA 70130.

    Contact Person: Alexei Kondratyev, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5200, MSC 7846, Bethesda, MD 20892, 301-435-1785, [email protected].

    Name of Committee: Molecular, Cellular and Developmental Neuroscience Integrated Review Group; Synapses, Cytoskeleton and Trafficking Study Section.

    Date: February 15-16, 2018.

    Time: 8:00 a.m. to 4:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: The Darcy Hotel, 1515 Rhode Island Ave. NW, Washington, DC 20005.

    Contact Person: Christine A Piggee, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4186, MSC 7850, Bethesda, MD 20892, 301-435-0657, [email protected].

    Name of Committee: Molecular, Cellular and Developmental Neuroscience Integrated Review Group; Neurotransporters, Receptors, and Calcium Signaling Study Section.

    Date: February 15-16, 2018.

    Time: 8:00 a.m. to 1:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Serrano Hotel, 405 Taylor Street, San Francisco, CA 94102.

    Contact Person: Peter B Guthrie, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4182, MSC 7850, Bethesda, MD 20892, (301) 435-1239, [email protected].

    065

    Name of Committee: Oncology 1-Basic Translational Integrated Review Group; Tumor Cell Biology Study Section.

    Date: February 15-16, 2018.

    8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Hotel Zoe, 425 North Point St., San Francisco, CA 94133.

    Contact Person: Charles Morrow, MD, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6202, MSC 7804, Bethesda, MD 20892, 301-408-9850. [email protected].

    Name of Committee: Population Sciences and Epidemiology Integrated Review Group; Social Sciences and Population Studies B Study Section.

    Date: February 15, 2018.

    Time: 8:00 a.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Sheraton Delfina Santa Monica Hotel, 530 West Pico Boulevard, Santa Monica, CA 90405.

    Contact Person: Kate Fothergill, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3142, Bethesda, MD 20892, 301-435-2309, [email protected].

    Name of Committee: Integrative, Functional and Cognitive Neuroscience Integrated Review Group; Neurobiology of Motivated Behavior Study Section.

    Date: February 15-16, 2018.

    Time: 8:00 a.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Embassy Suites DC Convention Center, 900 10th Street NW, Washington, DC 20001.

    Contact Person: Jasenka Borzan, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4214 MSC 7814, Bethesda, MD 20892-7814, 301-435-1260, [email protected].

    Name of Committee: Endocrinology, Metabolism, Nutrition and Reproductive Sciences Integrated Review Group; Integrative and Clinical Endocrinology and Reproduction Study Section.

    Date: February 15, 2018.

    Time: 8:00 a.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Embassy Suites by Hilton, Denver Intl. Airport, 7001 Yampa St., Denver, CO 80249.

    Contact Person: Dianne Hardy, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6175, MSC 7892, Bethesda, MD 20892, 301-435-1154, [email protected].

    Name of Committee: Cell Biology Integrated Review Group; Cellular Mechanisms in Aging and Development Study Section.

    Date: February 15-16, 2018.

    Time: 8:00 a.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: The Westin St. Francis, 335 Powell Street, San Francisco, CA 94102.

    Contact Person: John Burch, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institute of Health, 6701 Rockledge Drive, Room 3213, MSC 7808, Bethesda, MD 20892, 301-408-9519, [email protected].

    (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893, National Institutes of Health, HHS)
    Dated: January 11, 2018. David Clary, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-00870 Filed 1-18-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute Amended Notice of Meeting

    Notice is hereby given of a change in the meeting of the National Cancer Institute Special Emphasis Panel, February 08, 2018, 09:00 a.m. to February 08, 2018, 04:00 p.m., National Cancer Institute Shady Grove, 9609 Medical Center Drive, Rockville, MD 20850 which was published in the Federal Register on December 27, 2017, 82 FR 61309.

    This meeting notice is amended to change the meeting title from “Cancer Cachexia Therapy and Local Delivery of Chemopreventive Agents” to “TEP-9A: Local Delivery of Chemopreventive Agents for Cancer”. The meeting is closed to the public.

    Dated: January 9, 2018. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-00872 Filed 1-18-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute; Notice of Meeting

    Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the National Cancer Institute Clinical Trials and Translational Research Advisory Committee.

    The meeting will be open to the public. The open session will be videocast and can be accessed from the NIH Videocasting and Podcasting website (http://videocast.nih.gov/).

    Name of Committee: National Cancer Institute Clinical Trials and Translational Research Advisory Committee.

    Date: March 7, 2018.

    Time: 11:00 a.m. to 1:00 p.m.

    Agenda: Strategic Discussion of NCI's Clinical and Translational Research Programs.

    Place: National Institutes of Health, Building 31, Room 11A01, 31 Center Drive, Bethesda, MD 20892 (Virtual Meeting).

    Contact Person: Sheila A. Prindiville, MD, MPH, Director, Coordinating Center for Clinical Trials, National Institutes of Health, National Cancer Institute, Coordinating Center for Clinical Trials, 9609 Medical Center Drive Room 6W136, Rockville, MD 20850, 240-276-6173, [email protected].

    Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.

    Information is also available on the Institute's/Center's home page: http://deainfo.nci.nih.gov/advisory/ctac/ctac.htm, where an agenda and any additional information for the meeting will be posted when available.

    (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: January 11, 2018. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-00862 Filed 1-18-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the Microbiology, Infectious Diseases and AIDS Initial Review Group Microbiology and Infectious Diseases B Subcommittee.

    The meeting will be closed to the public as indicated below in accordance with the provisions set forth in sections 552b(c)(6), Title 5 U.S.C., as amended for review, discussion, and evaluation of individual intramural programs and projects conducted by the National Institute of Allergy and Infectious Diseases, including consideration of personnel qualifications and performance, and the competence of individual investors, the disclosure of which would constitue a clearly unwarranted invasion of personal privacy.

    Name of Committee: Microbiology, Infectious Diseases and AIDS Initial Review Group, Microbiology and Infectious Diseases B Subcommittee MID-B, February 2018.

    Date: February 12-13, 2018.

    Time: 8:00 a.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Bahia Resort Hotel, 3999 West Mission Bay Drive, San Diego, CA 92109.

    Contact Person: Ellen S. Buczko, Ph.D., Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, National Institutes of Health/NIAID, 6700B Rockledge Drive, MSC 7616, Bethesda, MD 20892-7616, 301-451-2676, [email protected].

    (Catalogue of Federal Domestic Assistance Program Nos. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, Microbiology and Infectious Diseases Research, National Institutes of Health, HHS)
    Dated: January 10, 2018. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-00867 Filed 1-18-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.

    The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: Musculoskeletal, Oral and Skin Sciences Integrated Review Group; Skeletal Muscle and Exercise Physiology Study Section.

    Date: February 8-9, 2018.

    Time: 8:00 a.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Hilton Long Beach and Executive Center, 701 West Ocean Boulevard, Long Beach, CA 90831.

    Contact Person: Richard Ingraham, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4116, MSC 7814, Bethesda, MD 20892, 301-496-8551, [email protected].

    Name of Committee: Population Sciences and Epidemiology Integrated Review Group; Neurological, Aging and Musculoskeletal Epidemiology Study Section.

    Date: February 8-9, 2018.

    Time: 8:30 a.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: JW Marriott New Orleans, 614 Canal Street, New Orleans, LA 70130.

    Contact Person: Heidi B. Friedman, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 1012A, MSC 7770, Bethesda, MD 20892, 301-435-1721, [email protected].

    Name of Committee: Infectious Diseases and Microbiology Integrated Review Group; Host Interactions with Bacterial Pathogens Study Section.

    Date: February 9, 2018.

    Time: 8:00 a.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814.

    Contact Person: Fouad A. El-Zaatari, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3186, MSC 7808, Bethesda, MD 20892, (301) 435-1149, [email protected].

    Name of Committee: Brain Disorders and Clinical Neuroscience Integrated Review Group; Aging Systems and Geriatrics Study Section.

    Date: February 12-13, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: The Westgate Hotel, 1055 Second Avenue, San Diego, CA 92101.

    Contact Person: Inese Z. Beitins, MD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6152, MSC 7892, Bethesda, MD 20892, 301-435-1034, [email protected].

    Name of Committee: Brain Disorders and Clinical Neuroscience Integrated Review Group; Brain Injury and Neurovascular Pathologies Study Section.

    Date: February 12-13, 2018.

    Time: 8:00 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: Alexander Yakovlev, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5206, MSC 7846, Bethesda, MD 20892, 301-435-1254, [email protected].

    Name of Committee: Biobehavioral and Behavioral Processes Integrated Review Group; Language and Communication Study Section.

    Date: February 13-14, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Villa Florence Hotel, 225 Powell Street, San Francisco, CA 94102.

    Contact Person: Wind Cowles, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive Room 3172, Bethesda, MD 20892, 301-437-7872, [email protected].

    Name of Committee: Integrative, Functional and Cognitive Neuroscience Integrated Review Group; Somatosensory and Chemosensory Systems Study Section.

    Date: February 13, 2018.

    Time: 8:00 a.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Hilton Long Beach and Executive Center, 701 West Ocean Boulevard, Long Beach, CA 90831.

    Contact Person: John Bishop, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5182, MSC 7844, Bethesda, MD 20892, (301) 408-9664, [email protected].

    (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393-93.396, 93.837-93.844, 93.846- 93.878, 93.892, 93.893, National Institutes of Health, HHS)
    Dated: January 10, 2018. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-00859 Filed 1-18-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.

    The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR-16-292 Mobile Health: Technology and Outcomes in Low and Middle Income Countries (R21).

    Date: February 8-9, 2018.

    Time: 8:00 a.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Bethesda North Marriott Hotel & Conference Center, 5701 Marinelli Road, Bethesda, MD 20852.

    Contact Person: Peter J Kozel, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3139, Bethesda, MD 20892, 301-435-1116, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR15-356: Major Opportunities for Research in Epidemiology of Alzheimer's Disease and Cognitive Resilience.

    Date: February 14, 2018.

    Time: 10:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).

    Contact Person: Heidi B Friedman, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 1012A, MSC 7770, Bethesda, MD 20892, 301-379-5632, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Investigations of Pain-Induced Modulation of Prescription Opioid Use and Misuse.

    Date: February 16, 2018.

    Time: 2:00 p.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Hilton Long Beach and Executive Center, 701 West Ocean Boulevard, Long Beach, CA 90831.

    Contact Person: M. Catherine Bennett, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5182, MSC 7846, Bethesda, MD 20892, 301-435-1766, [email protected]

    (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893, National Institutes of Health, HHS)
    Dated: January 12, 2018. Sylvia L. Neal, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-00861 Filed 1-18-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Deafness and Other Communication Disorders; Notice of Closed Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.

    The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Institute on Deafness and Other Communication Disorders Special Emphasis Panel; HB Translational Grant Review.

    Date: January 18, 2018.

    Time: 1:00 p.m. to 4:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852 (Virtual Meeting).

    Contact Person: Sheo Singh, Ph.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural Activities, 6001 Executive Blvd., Room 8351, Bethesda, MD 20892, 301-496-8683, [email protected]

    Name of Committee: National Institute on Deafness and Other Communication Disorders Special Emphasis Panel.

    Date: January 23, 2018.

    Time: 1:00 p.m. to 4:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852 (Virtual Meeting).

    Contact Person: Sheo Singh, Ph.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural Activities, 6001 Executive Blvd., Room 8351, Bethesda, MD 20892, 301-496-8683, [email protected]

    Name of Committee: National Institute on Deafness and Other Communication Disorders Special Emphasis Panel; NIDCD Clinical Trial (U01) in Language Review.

    Date: January 24, 2018.

    Time: 12:30 p.m. to 3:30 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852 (Virtual Meeting).

    Contact Person: Katherine Shim, Ph.D., Scientific Review Officer, Division of Extramural Activities, NIH/NIDCD, 6001 Executive Blvd., Room 8351, Bethesda, MD 20892, 301-496-8683, [email protected]

    (Catalogue of Federal Domestic Assistance Program Nos. 93.173, Biological Research Related to Deafness and Communicative Disorders, National Institutes of Health, HHS)
    Dated: January 9, 2018. Sylvia L. Neal, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-00873 Filed 1-18-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.

    The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: Cell Biology Integrated Review Group, Nuclear and Cytoplasmic Structure/Function and Dynamics Study Section.

    Date: January 29, 2018.

    Time: 9:00 a.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Virtual Meeting).

    Contact Person: David Balasundaram, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5189, MSC 7840, Bethesda, MD 20892, 301-435-1022, [email protected]

    This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.

    Name of Committee: Center for Scientific Review Special Emphasis Panel, Science Education Partnership Awards (SEPA).

    Date: February 1-2, 2018.

    Time: 8:00 a.m. to 2:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Cambria Hotel and Suites, 1 Helen Heneghan Way, Rockville, MD 20850.

    Contact Person: Jonathan Arias, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5170, MSC 7840, Bethesda, MD 20892, 301-435-2406, [email protected]

    Name of Committee: Brain Disorders and Clinical Neuroscience Integrated Review Group, Developmental Brain Disorders Study Section.

    Date: February 1-2, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Catamaran Resort, 3999 Mission Boulevard, San Diego, CA 92109.

    Contact Person: Pat Manos, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5200, MSC 7846, Bethesda, MD 20892, 301-408-9866, [email protected]

    Name of Committee: Immunology Integrated Review Group, Cellular and Molecular Immunology—B Study Section.

    Date: February 1-2, 2018.

    Time: 8:30 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: The William F. Bolger Center, 9600 Newbridge Drive, Potomac, MD 20854.

    Contact Person: Betty Hayden, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4206, MSC 7812, Bethesda, MD 20892, 301-435-1223, [email protected]

    Name of Committee: Oncology 2—Translational Clinical Integrated Review Group, Basic Mechanisms of Cancer Therapeutics Study Section.

    Date: February 5-6, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Ritz Carlton Pentagon City, 1250 South Hayes Street, Arlington, VA 22202.

    Contact Person: Lambratu Rahman Sesay, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6214, MSC 7804, Bethesda, MD 20892, 301-451-3493, [email protected]

    Name of Committee: Cell Biology Integrated Review Group, Cellular Signaling and Regulatory Systems Study Section.

    Date: February 6-7, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Cambria Hotel and Suites, 1 Helen Heneghan Way, Rockville, MD 20850.

    Contact Person: Elena Smirnova, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5187, MSC 7840, Bethesda, MD 20892, 301-357-9112, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel, PAR Panel: Decision Making and Aging in Alzheimer's Disease.

    Date: February 7, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).

    Contact Person: Kristin Kramer, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5205, MSC 7846, Bethesda, MD 20892, (301) 437-0911, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel, PAR-17-275: Mammalian Models for Translational Research.

    Date: February 7, 2018.

    Time: 11:00 a.m. to 4:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).

    Contact Person: Careen K Tang-Toth, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6214, MSC 7804, Bethesda, MD 20892, (301) 435-3504, [email protected]

    Name of Committee: Brain Disorders and Clinical Neuroscience Integrated Review Group, Clinical Neuroimmunology and Brain Tumors Study Section.

    Date: February 8-9, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Argonaut Hotel, 495 Jefferson Street, San Francisco, CA 94109.

    Contact Person: Wei-Qin Zhao, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5181, MSC 7846, Bethesda, MD 20892-7846, 301-435-1236, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel, Auditory Science.

    Date: February 8, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: The Westgate Hotel, 1055 Second Avenue, San Diego, CA 92101.

    Contact Person: Nicholas Gaiano, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5178, MSC 7844, Bethesda, MD 20892-7844, 301-435-1033, [email protected]

    (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893, National Institutes of Health, HHS)
    Dated: January 10, 2018. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-00876 Filed 1-18-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of General Medical Sciences; Notice of Closed Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.

    The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: NIGMS Initial Review Group; Training and Workforce Development Subcommittee—C Review K12 and R25 Research Training Grant Applications.

    Date: March 12-13, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Residence Inn Bethesda Downtown, 7335 Wisconsin Avenue, Bethesda, MD 20814.

    Contact Person: Lee Warren Slice, Ph.D., Scientific Review Officer, Office of Scientific Review, National Institute of General Medical Sciences, National Institutes of Health, 1 Democracy Plaza, 6701 Democracy Blvd., Room 1068, Bethesda, MD 20892, 301-435-0807, [email protected]

    Name of Committee: NIGMS Initial Review Group; Training and Workforce Development Subcommittee—D Review of K12 and R25 applications.

    Date: March 15-16, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Hyatt Regency Bethesda, 7400 Wisconsin Avenue, Bethesda, MD 20814.

    Contact Person: Tracy Koretsky, Ph.D., Scientific Review Officer, National Institute of General Medical Sciences, National Institutes of Health, 45 Center Drive, MSC 6200, Room 3An.12F, Bethesda, MD 20892, 301 594 2886, [email protected]

    (Catalogue of Federal Domestic Assistance Program Nos. 93.375, Minority Biomedical Research Support; 93.821, Cell Biology and Biophysics Research; 93.859, Pharmacology, Physiology, and Biological Chemistry Research; 93.862, Genetics and Developmental Biology Research; 93.88, Minority Access to Research Careers; 93.96, Special Minority Initiatives; 93.859, Biomedical Research and Research Training, National Institutes of Health, HHS)
    Dated: January 11, 2018. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-00871 Filed 1-18-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of General Medical Sciences; 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 General Medical Sciences Special Emphasis Panel; ESI MIRA Review.

    Date: March 1-2, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Residence Inn Bethesda Downtown, 7335 Wisconsin Avenue, Bethesda, MD 20814.

    Contact Person: Manas Chattopadhyay, Ph.D., Scientific Review Officer, National Institute of General Medical Sciences, National Institutes of Health, Building 45, Room 3An12N, 45 Center Drive, Bethesda, MD 20892, 301-827-5320, [email protected]

    (Catalogue of Federal Domestic Assistance Program Nos. 93.375, Minority Biomedical Research Support; 93.821, Cell Biology and Biophysics Research; 93.859, Pharmacology, Physiology, and Biological Chemistry Research; 93.862, Genetics and Developmental Biology Research; 93.88, Minority Access to Research Careers; 93.96, Special Minority Initiatives; 93.859, Biomedical Research and Research Training, National Institutes of Health, HHS)
    Dated: January 11, 2018. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-00869 Filed 1-18-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.

    The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel; PHS2018-1 SBIR Topic 59: Diagnostics to Enable Malaria and Neglected Tropical Diseases (NTDs) Elimination.

    Date: February 8-9, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate contract proposals.

    Place: National Institutes of Health, 5601 Fishers Lane, Rockville, MD 20892 (Telephone Conference Call).

    Contact Person: Brenda Lange-Gustafson, Ph.D., Scientific Review Officer, NIAID/NIH/DHHS, Scientific Review Program, 5601 Fishers Lane, Room 3G13, Rockville, MD 20852, 240-669-5047, [email protected]

    Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel; Informatics Methodology and Secondary Analyses for Immunology Data in ImmPort (UH2).

    Date: February 12, 2018.

    Time: 10:00 a.m. to 1:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 5601 Fishers Lane, Rockville, MD 20892 (Telephone Conference Call).

    Contact Person: Paul A. Amstad, Ph.D., Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, Room 3G41, NIAID/NIH/DHHS, 5601 Fishers Lane, Bethesda, MD 20892-7616, 240-669-5067, [email protected]

    (Catalogue of Federal Domestic Assistance Program Nos. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, Microbiology and Infectious Diseases Research, National Institutes of Health, HHS)
    Dated: January 10, 2018. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-00866 Filed 1-18-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Deafness and Other Communication Disorders; Notice of Closed Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.

    The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Institute on Deafness and Other Communication Disorders Special Emphasis Panel. Chemosensory Fellowship Applications Review.

    Date: February 1, 2018.

    Time: 11:00 a.m. to 3:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852 (Virtual Meeting).

    Contact Person: Shiguang Yang, DVM, Ph.D., Scientific Review Officer, Division of Extramural Activities, NIDCD, NIH, 6001 Executive Blvd., Room 8349, Bethesda, MD 20892, 301-496-8683, [email protected].

    Name of Committee: Communication Disorders Review Committee.

    Date: February 8-9, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Kimpton Solamar Hotel, 435 6th Avenue at J Street, San Diego, CA 92101.

    Contact Person: Eliane Lazar-Wesley, Ph.D., Scientific Review Officer, Division of Extramural Activities, National Institute on Deafness and other Communication Disorders/NIH, 6001 Executive Blvd., MSC 9670, Bethesda, MD 20892-8401, 301-496-8683, [email protected].

    Name of Committee: National Institute on Deafness and Other Communication Disorders Special Emphasis Panel, Hearing and Balance Fellowship Review.

    Date: February 9, 2018.

    Time: 11:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Kimpton Solamar, 435 6th Avenue, San Diego, CA 92101.

    Contact Person: Kausik Ray, Ph.D., Scientific Review Officer, National Institute on Deafness and Other Communication Disorders, National Institutes of Health, Rockville, MD 20850, 301-402-3587, [email protected].

    Name of Committee: National Institute on Deafness and Other Communication Disorders Special Emphasis Panel, NIDCD Clinical Trial (U01) in the Chemical Senses Review.

    Date: February 14, 2018.

    Time: 2:00 p.m. to 4:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852 (Virtual Meeting).

    Contact Person: Katherine Shim, Ph.D., Scientific Review Officer, Division of Extramural Activities, NIH/NIDCD, 6001 Executive Blvd., Room 8351, Bethesda, MD 20892, 301-496-8683, [email protected].

    Name of Committee: National Institute on Deafness and Other Communication Disorders Special Emphasis Panel, VSL Fellowships Review.

    Date: February 20, 2018.

    Time: 11:00 a.m. to 3:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852 (Virtual Meeting).

    Contact Person: Shiguang Yang, DVM, Ph.D., Scientific Review Officer, Division of Extramural Activities, NIDCD, NIH, 6001 Executive Blvd., Room 8349, Bethesda, MD 20892, 301-496-8683, [email protected].

    (Catalogue of Federal Domestic Assistance Program Nos. 93.173, Biological Research Related to Deafness and Communicative Disorders, National Institutes of Health, HHS)
    Dated: January 9, 2018. Sylvia L. Neal, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-00874 Filed 1-18-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Eunice Kennedy Shriver National Institute of Child Health and Human Development; Amended Notice of Meeting

    Notice is hereby given of a change in the meeting of the Population Sciences Subcommittee, February 9, 2017, 08:00 a.m. to February 9, 2017, 05:00 p.m., Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, MD, 20814 which was published in the Federal Register on December 18, 2017, Vol. 82 242479 Pg. 60026.

    The meeting date has changed from February 9, 2017, 8:00 a.m. to 5:00 p.m. to February 9, 2018, 8:00 a.m. to 5:00 p.m. The meeting is closed to the public.

    Dated: January 10, 2018. Michelle Trout, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-00868 Filed 1-18-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome Research Institute; Notice of Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of meetings of the National Advisory Council for Human Genome Research.

    The meetings will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting.

    The 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 Advisory Council for Human Genome Research.

    Date: February 12-13, 2018.

    Closed: February 12, 2018, 8:00 a.m. to 10:00 a.m.

    Agenda: To review and evaluate grant applications and/or proposals.

    Place: National Institutes of Health, T-Level 508-510, 5635 Fishers Lane, Bethesda, MD 20892.

    Open: February 12, 2018, 10:00 a.m. to 4:00 p.m.

    Agenda: To discuss matters of program relevance.

    Place: National Institutes of Health, T-Level 508-510, 5635 Fishers Lane, Bethesda, MD 20892.

    Closed: February 12, 2018, 4:00 p.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications and/or proposals.

    Place: National Institutes of Health, T-Level 508-510, 5635 Fishers Lane, Bethesda, MD 20892.

    Closed: February 13, 2018, 8:00 a.m. to Adjournment.

    Agenda: To review and evaluate grant applications and/or proposals.

    Place: National Institutes of Health, T-Level 508-510, 5635 Fishers Lane, Bethesda, MD 20892.

    Contact Person: Rudy O. Pozzatti, Ph.D., Scientific Review Officer, Scientific Review Branch, National Human Genome Research Institute, 5635 Fishers Lane, Suite 4076, MSC 9306, Rockville, MD 20852, (301) 402-0838, [email protected].

    Name of Committee: National Advisory Council for Human Genome Research.

    Date: May 21-22, 2018.

    Closed: May 21, 2018, 8:00 a.m. to 10:00 a.m.

    Agenda: To review and evaluate grant applications and/or proposals.

    Place: National Institutes of Health, Rockledge 6700 Conference Center, 1st Floor Room: A/B/C, 6700B Rockledge Drive, Bethesda, MD 20817.

    Open: May 21, 2018, 10:00 a.m. to 4:00 p.m.

    Agenda: To discuss matters of program relevance.

    Place: National Institutes of Health, Rockledge 6700 Conference Center, 1st Floor Room: A/B/C, 6700B Rockledge Drive, Bethesda, MD 20817.

    Closed: May 21, 2018, 4:00 p.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications and/or proposals.

    Place: National Institutes of Health, Rockledge 6700 Conference Center, 1st Floor Room: A/B/C, 6700B Rockledge Drive, Bethesda, MD 20817.

    Closed: May 22, 2018, 8:00 a.m. to Adjournment.

    Agenda: To review and evaluate grant applications and/or proposals.

    Place: National Institutes of Health, Rockledge 6700 Conference Center, 1st Floor Room: A/B/C, 6700B Rockledge Drive, Bethesda, MD 20817.

    Contact Person: Rudy O. Pozzatti, Ph.D., Scientific Review Officer, Scientific Review Branch, National Human Genome Research Institute, 5635 Fishers Lane, Suite 4076, MSC 9306, Rockville, MD 20852, (301) 402-0838, [email protected].

    Name of Committee: National Advisory Council for Human Genome Research.

    Date: September 24-25, 2018.

    Closed: September 24, 2018, 8:00 a.m. to 10:00 a.m.

    Agenda: To review and evaluate grant applications and/or proposals.

    Place: National Institutes of Health, Rockledge 6700 Rockledge Conference Center, 1st Floor Room: A/B/C, 6700B Rockledge Drive, Bethesda, MD 20817.

    Open: September 24, 2018, 10:00 a.m. to 4:00 p.m.

    Agenda: To discuss matters of program relevance.

    Place: National Institutes of Health, Rockledge 6700 Rockledge Conference Center, 1st Floor Room: A/B/C, 6700B Rockledge Drive, Bethesda, MD 20817.

    Closed: September 24, 2018, 4:00 p.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications and/or proposals.

    Place: National Institutes of Health, Rockledge 6700 Rockledge Conference Center, 1st Floor Room: A/B/C, 6700B Rockledge Drive, Bethesda, MD 20817.

    Closed: September 25, 2018, 8:00 a.m. to Adjournment.

    Agenda: To review and evaluate grant applications and/or proposals.

    Place: National Institutes of Health, Rockledge 6700 Rockledge Conference Center, 1st Floor Room: A/B/C, 6700B Rockledge Drive, Bethesda, MD 20817.

    Contact Person: Rudy O. Pozzatti, Ph.D., Scientific Review Officer, Scientific Review Branch, National Human Genome Research Institute, 5635 Fishers Lane, Suite 4076, MSC 9306, Rockville, MD 20852, (301) 402-0838, [email protected].

    Information is also available on the Institute's/Center's home page: http://www.genome.gov/11509849, where an agenda and any additional information for the meeting will be posted when available.

    (Catalogue of Federal Domestic Assistance Program Nos. 93.172, Human Genome Research, National Institutes of Health, HHS)
    Dated: January 12, 2018. Sylvia L. Neal, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-00863 Filed 1-18-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.

    The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel; PHS 2018-1: Small Business Innovation Research (SBIR) Program Contract Solicitation (Topic 51) (N01).

    Date: February 2, 2018.

    Time: 9:30 a.m. to 5:00 p.m.

    Agenda: To review and evaluate contract proposals.

    Place: National Institutes of Health, 5601 Fishers Lane, Rockville, MD 20892 (Telephone Conference Call).

    Contact Person: Roberta Binder, Ph.D., Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, Room 3G21A, National Institutes of Health/NIAID, 5601 Fishers Lane, MSC 9823, Bethesda, MD 20892-9823, (240) 669-5050, [email protected].

    Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel; NIAID Clinical Trial Planning Grant (R34).

    Date: February 7, 2018.

    Time: 1:00 p.m. to 2:30 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 5601 Fishers Lane, Rockville, MD 20892 (Telephone Conference Call).

    Contact Person: Roberta Binder, Ph.D., Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, Room 3G21A, National Institutes of Health/NIAID, 5601 Fishers Lane, MSC 9823, Bethesda, MD 20892-9823, (240) 669-5050, [email protected].

    Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel; NIH Peer Review Meeting.

    Date: February 7-8, 2018.

    Time: 12:00 p.m. to 4:00 p.m.

    Agenda: To review and evaluate contract proposals.

    Place: National Institutes of Health, 5601 Fishers Lane, Rockville, MD 20892 (Telephone Conference Call).

    Contact Person: Ann Marie M. Cruz, Ph.D., Scientific Review Officer, Program Management & Operations Branch DEA/SRP, Rm. 3E71, National Institutes of Health, NIAID, 5601 Fishers Lane, Rockville, MD 20852, 301-761-3100, [email protected].

    (Catalogue of Federal Domestic Assistance Program Nos. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, Microbiology and Infectious Diseases Research, National Institutes of Health, HHS)
    Dated: January 10, 2018. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-00865 Filed 1-18-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard [Docket No. USCG-2009-0973] Random Drug Testing Rate for Covered Crewmembers for 2018 AGENCY:

    Coast Guard, DHS.

    ACTION:

    Notice of minimum random drug testing rate.

    SUMMARY:

    The Coast Guard has set the calendar year 2018 minimum random drug testing rate at 25 percent of covered crewmembers.

    DATES:

    The minimum random drug testing rate is effective January 1, 2018 through December 31, 2018.

    Marine employers must submit their 2017 Management Information System (MIS) reports no later than March 15, 2018.

    ADDRESSES:

    Annual MIS reports may be submitted by electronic submission to the following email address: [email protected].

    FOR FURTHER INFORMATION CONTACT:

    For questions about this notice, please contact Mr. Patrick Mannion, Drug and Alcohol Prevention and Investigation Program Manager, Office of Investigations and Casualty Analysis (CG-INV), U.S. Coast Guard Headquarters, telephone 202-372-1033.

    SUPPLEMENTARY INFORMATION:

    The Coast Guard requires marine employers to establish random drug testing programs for covered crewmembers on inspected and uninspected vessels in accordance with 46 CFR 16.230. Every marine employer is required by 46 CFR 16.500 to collect and maintain a record of drug testing program data for each calendar year, and submit this data by 15 March of the following year to the Coast Guard in an annual MIS report.

    Each year, the Coast Guard will publish a notice reporting the results of random drug testing for the previous calendar year's MIS data and the minimum annual percentage rate for random drug testing for the next calendar year. The purpose of setting a minimum random drug testing rate is to assist the Coast Guard in analyzing its current approach for deterring and detecting illegal drug abuse in the maritime industry.

    The Coast Guard announces that the minimum random drug testing rate for calendar year 2018 is 25 percent. The Coast Guard may increase this rate if MIS data indicates a qualitative deficiency of reported data or the positive random testing rate is greater than 1.0 percent in accordance with 46 CFR part 16.230(f)(2). MIS data for the most recent reporting year indicates that the positive rate is less than one percent.

    For 2018, the minimum random drug testing rate will continue at 25 percent of covered employees for the period of January 1, 2018 through December 31, 2018 in accordance with 46 CFR 16.230(e).

    Dated: January 12, 2018. Jennifer F. Williams, Captain, U.S. Coast Guard, Director of Inspections and Compliance.
    [FR Doc. 2018-00884 Filed 1-18-18; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF HOMELAND SECURITY U.S. Customs and Border Protection [1651-0075] Agency Information Collection Activities: Drawback Process Regulations AGENCY:

    U.S. Customs and Border Protection (CBP), Department of Homeland Security.

    ACTION:

    60-Day notice and request for comments; extension of an existing collection of information.

    SUMMARY:

    The Department of Homeland Security, U.S. Customs and Border Protection will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (PRA). The information collection is published in the Federal Register to obtain comments from the public and affected agencies. Comments are encouraged and will be accepted (no later than March 20, 2018) to be assured of consideration.

    ADDRESSES:

    Written comments and/or suggestions regarding the item(s) contained in this notice must include the OMB Control Number 1651-0075 in the subject line and the agency name. To avoid duplicate submissions, please use only one of the following methods to submit comments:

    (1) Email. Submit comments to: [email protected]

    (2) Mail. Submit written comments to CBP Paperwork Reduction Act Officer, U.S. Customs and Border Protection, Office of Trade, Regulations and Rulings, Economic Impact Analysis Branch, 90 K Street NE, 10th Floor, Washington, DC 20229-1177.

    FOR FURTHER INFORMATION CONTACT:

    Requests for additional PRA information should be directed to Seth Renkema, Chief, Economic Impact Analysis Branch, U.S. Customs and Border Protection, Office of Trade, Regulations and Rulings, 90 K Street NE, 10th Floor, Washington, DC 20229-1177, Telephone number (202) 325-0056 or via email [email protected] Please note that the contact information provided here is solely for questions regarding this notice. Individuals seeking information about other CBP programs should contact the CBP National Customer Service Center at 877-227-5511, (TTY) 1-800-877-8339, or CBP website at https://www.cbp.gov/.

    SUPPLEMENTARY INFORMATION:

    CBP invites the general public and other Federal agencies to comment on the proposed and/or continuing information collections pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). This process is conducted in accordance with 5 CFR 1320.8. Written comments and suggestions from the public and affected agencies should address one or more of the following four points: (1) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) suggestions to enhance the quality, utility, and clarity of the information to be collected; and (4) suggestions 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, e.g., permitting electronic submission of responses. The comments that are submitted will be summarized and included in the request for approval. All comments will become a matter of public record.

    Overview of This Information Collection

    Title: Drawback Process Regulations.

    OMB Number: 1651-0075.

    Form Number: CBP Forms 7551, 7552 and 7553.

    Current Actions: This submission is being made to extend the expiration date of this information collection with a decrease to the burden hours due to updated agency estimates. There is no change CBP Forms 7551, 7552, 7553, or to the information being collected.

    Type of Review: Extension (without change).

    Abstract: The collections of information related to the drawback process are required to implement the provisions of 19 CFR part 191, and certain provisions of part 181 (regarding NAFTA drawback claims), which provide for refunds of duties, as well as taxes and fees in certain situations, imposed merchandise where there is a subsequent related exportation or destruction. The claims referred to in this notice are limited to drawback claims filed in compliance with the regulations in parts 181 and 191 and under 19 U.S.C. 1313, as it was in effect prior to the amendments made by the Trade Facilitation and Trade Enforcement Act of 2015 (TFTEA) (Pub. L. 114-125, 130 stat. 122, February 24, 2016). If the requirements set forth in Parts 181 and 191 are met, claimants may file for a refund using CBP Form 7551, Drawback Entry. CBP Form 7552, Delivery Certificate for Purposes of Drawback, is used to record transfers of merchandise and is also used each time a change to the merchandise occurs as a result of a manufacturing operation. CBP Form 7553, Notice of Intent to Export, Destroy or Return Merchandise for Purposes of Drawback, is used to notify CBP if an exportation, destruction, or return of the imported merchandise will take place. The information collected on these forms is authorized by 19 U.S.C. 1313(l). The drawback forms are accessible at http://www.cbp.gov/newsroom/publications/forms.

    Affected Public: Businesses.

    CBP Form 7551, Drawback Entry

    Estimated Number of Respondents: 2,516.

    Estimated Number of Responses per Respondent: 20.205.

    Estimated Number of Total Annual Responses: 50.836.

    Estimated Time per Response: 35 minutes.

    Estimated Total Annual Burden Hours: 29,652.

    CBP Form 7552, Delivery Certificate for Drawback

    Estimated Number of Respondents: 2,000.

    Estimated Number of Responses per Respondent: 20.

    Estimated Number of Total Annual Responses: 40,000.

    Estimated Time per Response: 33 minutes.

    Estimated Total Annual Burden Hours: 22,000.

    CBP Form 7553, Notice of Intent To Export, Destroy or Return Merchandise for Purposes of Drawback

    Estimated Number of Respondents: 150.

    Estimated Number of Responses per Respondent: 20.

    Estimated Number of Total Annual Responses: 3,000.

    Estimated Time per Response: 33 minutes.

    Estimated Total Annual Burden Hours: 1,650.

    Dated: January 16, 2018. Seth Renkema, Branch Chief, Economic Impact Analysis Branch, U.S. Customs and Border Protection.
    [FR Doc. 2018-00895 Filed 1-18-18; 8:45 am] BILLING CODE 9111-14-P
    DEPARTMENT OF HOMELAND SECURITY U.S. Citizenship and Immigration Services [OMB Control Number 1615-0116] Agency Information Collection Activities; Extension, Without Change, of a Currently Approved Collection; Request for Fee Waiver; Request for Fee Exemption AGENCY:

    U.S. Citizenship and Immigration Services, Department of Homeland Security.

    ACTION:

    30-Day notice.

    SUMMARY:

    The Department of Homeland Security (DHS), U.S. Citizenship and Immigration Services (USCIS) will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995. The purpose of this notice is to allow an additional 30 days for public comments.

    DATES:

    The purpose of this notice is to allow an additional 30 days for public comments. Comments are encouraged and will be accepted until February 20, 2018. This process is conducted in accordance with 5 CFR 1320.10.

    ADDRESSES:

    Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, must be directed to the OMB USCIS Desk Officer via email at [email protected] Comments may also be submitted via fax at (202) 395-5806. (This is not a toll-free number.) All submissions received must include the agency name and the OMB Control Number 1615-0116.

    You may wish to consider limiting the amount of personal information that you provide in any voluntary submission you make. For additional information please read the Privacy Act notice that is available via the link in the footer of http://www.regulations.gov.

    FOR FURTHER INFORMATION CONTACT:

    USCIS, Office of Policy and Strategy, Regulatory Coordination Division, Samantha Deshommes, Chief, 20 Massachusetts Avenue NW., Washington, DC 20529-2140, Telephone number (202) 272-8377 (This is not a toll-free number; comments are not accepted via telephone message.). Please note contact information provided here is solely for questions regarding this notice. It is not for individual case status inquiries. Applicants seeking information about the status of their individual cases can check Case Status Online, available at the USCIS website at http://www.uscis.gov, or call the USCIS National Customer Service Center at (800) 375-5283; TTY (800) 767-1833.

    SUPPLEMENTARY INFORMATION: Comments

    The information collection notice was previously published in the Federal Register on October 11, 2017, at 82 FR 47234, allowing for a 60-day public comment period. USCIS did receive two comments in connection with the 60-day notice.

    You may access the information collection instrument with instructions, or additional information by visiting the Federal eRulemaking Portal site at: http://www.regulations.gov and enter USCIS-2010-0008 in the search box. Written comments and suggestions from the public and affected agencies should address one or more of the following four points:

    (1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

    (2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

    (3) Enhance the quality, utility, and clarity of the information to be collected; and

    (4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

    Overview of This Information Collection

    (1) Type of Information Collection Request: Extension, Without Change, of a Currently Approved Collection.

    (2) Title of the Form/Collection: Request for Fee Waiver; Request for Fee Exemption

    (3) Agency form number, if any, and the applicable component of the DHS sponsoring the collection: Form I-912; USCIS.

    (4) Affected public who will be asked or required to respond, as well as a brief abstract: Primary: Individuals or households. USCIS uses the data collected on this form to verify that the applicant is unable to pay for the immigration benefit being requested. USCIS will consider waiving a fee for an application or petition when the applicant or petitioner clearly demonstrates that he or she is unable to pay the fee. The regulations do not require that requests for fee waivers be submitted on a particular form prescribed by DHS, thus the applicant may request that the fee be waived by attaching a written request to the front of their immigration benefit request. Fee waivers may also be requested by completing and submitting Form I-912. Form I-912 standardizes the collection and analysis of statements and supporting documentation provided by the applicant with the fee waiver request. Form I-912 also streamlines and expedites the USCIS review, approval, or denial of the fee waiver request by clearly laying out the most salient data and evidence necessary for the determination of inability to pay. Officers evaluate all factors, circumstances, and evidence supplied in support of a fee waiver request when making a final determination. Each case is unique and is considered on its own merits. If the fee waiver is granted, the application will be processed. If the fee waiver is not granted, USCIS will notify the applicant and instruct him or her to file a new application with the appropriate fee.

    Certain applications and petitions may allow for filing of fee exemptions; the specific forms have information regarding the option and the requirements to request an exemption.

    (5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: The estimated total number of respondents for the information collection Form I-912 is 594,000 and the estimated hour burden per response is 1.17. The estimated total number of respondents for the information collection Non-form request for fee waiver is 8,400 and the estimated hour burden per response is 1.17. The estimated total number of respondents for the information collection 8 CFR 103.7(d) Director's exception request is 128 and the estimated hour burden per response is 1.17.

    (6) An estimate of the total public burden (in hours) associated with the collection: The total estimated annual hour burden associated with this collection is 704,958 hours.

    (7) An estimate of the total public burden (in cost) associated with the collection: The estimated total annual cost burden associated with this collection is $2,259,480.

    Dated: January 12, 2018. Samantha Deshommes, Chief, Regulatory Coordination Division, Office of Policy and Strategy, U.S. Citizenship and Immigration Services, Department of Homeland Security.
    [FR Doc. 2018-00830 Filed 1-18-18; 8:45 am] BILLING CODE 9111-97-P
    DEPARTMENT OF HOMELAND SECURITY U.S. Citizenship and Immigration Services [OMB Control Number 1615-0114] Agency Information Collection Activities: Revision of a Currently Approved Collection: Application for Civil Surgeon Designation AGENCY:

    U.S. Citizenship and Immigration Services, Department of Homeland Security.

    ACTION:

    60-Day notice.

    SUMMARY:

    The Department of Homeland Security (DHS), U.S. Citizenship and Immigration (USCIS) invites the general public and other Federal agencies to comment upon this proposed revision of a currently approved collection of information. In accordance with the Paperwork Reduction Act (PRA) of 1995, the information collection notice is published in the Federal Register to obtain comments regarding the nature of the information collection, the categories of respondents, the estimated burden (i.e. the time, effort, and resources used by the respondents to respond), the estimated cost to the respondent, and the actual information collection instruments.

    DATES:

    Comments are encouraged and will be accepted for 60 days until March 20, 2018.

    ADDRESSES:

    All submissions received must include the OMB Control Number 1615-0114 in the body of the letter, the agency name and Docket ID USCIS-2013-0002. To avoid duplicate submissions, please use only one of the following methods to submit comments:

    (1) Online. Submit comments via the Federal eRulemaking Portal website at http://www.regulations.gov under e-Docket ID number USCIS-2013-0002;

    (2) Mail. Submit written comments to DHS, USCIS, Office of Policy and Strategy, Chief, Regulatory Coordination Division, 20 Massachusetts Avenue NW, Washington, DC 20529-2140.

    FOR FURTHER INFORMATION CONTACT:

    USCIS, Office of Policy and Strategy, Regulatory Coordination Division, Samantha Deshommes, Chief, 20 Massachusetts Avenue NW, Washington, DC 20529-2140, telephone number 202-272-8377 (This is not a toll-free number. Comments are not accepted via telephone message). Please note contact information provided here is solely for questions regarding this notice. It is not for individual case status inquiries. Applicants seeking information about the status of their individual cases can check Case Status Online, available at the USCIS website at http://www.uscis.gov, or call the USCIS National Customer Service Center at 800-375-5283 (TTY 800-767-1833).

    SUPPLEMENTARY INFORMATION: Comments

    You may access the information collection instrument with instructions, or additional information by visiting the Federal eRulemaking Portal site at: http://www.regulations.gov and enter USCIS-2013-0002 in the search box. 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 consider limiting the amount of personal information that you provide in any voluntary submission you make to DHS. DHS may withhold information provided in comments from public viewing that it determines may impact the privacy of an individual or is offensive. For additional information, please read the Privacy Act notice that is available via the link in the footer of http://www.regulations.gov.

    Written comments and suggestions from the public and affected agencies should address one or more of the following four points:

    (1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

    (2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

    (3) Enhance the quality, utility, and clarity of the information to be collected; and

    (4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

    Overview of This Information Collection

    (1) Type of Information Collection: Revision of a Currently Approved Collection.

    (2) Title of the Form/Collection: Application for Civil Surgeon Designation.

    (3) Agency form number, if any, and the applicable component of the DHS sponsoring the collection: Form I-910; USCIS.

    (4) Affected public who will be asked or required to respond, as well as a brief abstract: Primary: Business or other for-profit. This information collection is required to determine whether a physician meets the statutory and regulatory requirement for civil surgeon designation. For example, all documents are reviewed to determine whether the physician has a currently valid medical license and whether the physician has had any action taken against him or her by the medical licensing authority of the U.S. state(s) or U.S. territories in which he or she practices. If the Application for Civil Surgeon Designation (Form I-910) is approved, the physician is included in USCIS' public Civil Surgeon locator and is authorized to complete Form I-693 (OMB Control Number 1615-0033) for an applicant's adjustment of status.

    (5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: The estimated total number of respondents for the information collection Form I-910 is 538 and the estimated hour burden per response is 2 hours.

    (6) An estimate of the total public burden (in hours) associated with the collection: The total estimated annual hour burden associated with this collection is 1,076 hours.

    (7) An estimate of the total public burden (in cost) associated with the collection: The estimated total annual cost burden associated with this collection of information is $26,460.

    Dated: January 12, 2018. Samantha Deshommes, Chief, Regulatory Coordination Division, Office of Policy and Strategy, U.S. Citizenship and Immigration Services, Department of Homeland Security.
    [FR Doc. 2018-00831 Filed 1-18-18; 8:45 am] BILLING CODE 9111-97-P
    DEPARTMENT OF JUSTICE Bureau of Alcohol, Tobacco, Firearms and Explosives [OMB Number 1140-0106] Agency Information Collection Activities; Proposed eCollection eComments Requested; Arson and Explosives Training Registration Request for Non-ATF Employees—ATF F 6310.1 AGENCY:

    Bureau of Alcohol, Tobacco, Firearms and Explosives, Department of Justice.

    ACTION:

    Notice.

    SUMMARY:

    The Department of Justice, Bureau of Alcohol, Tobacco, Firearms and Explosives, is submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The proposed information collection was previously published in the Federal Register, on November 9, 2017, allowing for a 60-day comment.

    DATES:

    The Department of Justice encourages public comment and will accept input until February 20, 2018.

    FOR FURTHER INFORMATION CONTACT:

    If you have additional comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Roderic Spencer, National Center for Explosives Training and Research (NCETR) either by mail at 3750 Corporal Road, Redstone Arsenal, AL 35898, or by email at [email protected], or by telephone at 256-261-7608. Written comments and/or suggestions can also be sent to the Office of Management and Budget, Office of Information and Regulatory Affairs, Attention Department of Justice Desk Officer, Washington, DC 20503 or sent to [email protected]

    SUPPLEMENTARY INFORMATION:

    Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:

    —Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Bureau of Alcohol, Tobacco, Firearms and Explosives, including whether the information will have practical utility; —Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; —Evaluate whether and if so how the quality, utility, and clarity of the information to be collected can be enhanced; and —Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. Overview of This Information Collection

    1. Type of Information Collection: Extension, without change, of a currently approved collection.

    2. The Title of the Form/Collection: Arson and Explosives Training Registration Request for Non-ATF Employees.

    3. The agency form number, if any, and the applicable component of the Department sponsoring the collection: ATF F 6310.1. The applicable component within the Department of Justice is the Bureau of Alcohol, Tobacco, Firearms and Explosives.

    4. Affected public who will be asked or required to respond, as well as a brief abstract:

    Primary: State and Local Government.

    Other: Federal Government.

    Abstract: The form is used to obtain information from Federal, State and local, and international law enforcement, and military investigator personnel applying for training conducted by ATF, for the purpose of student registration, program information and program evaluation. The information on the form will be used to determine the eligibility of the applicant to attend the training.

    5. An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: An estimated 500 respondents will utilize the form, and it will take each respondent 6 minutes to complete the form.

    6. An estimate of the total public burden (in hours) associated with the collection: The estimated annual public burden associated with this collection is 50 hours which is equal to 500 (# of respondents) * .1(6 minutes).

    If additional information is required contact: Melody Braswell, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE, 3E.405A, Washington, DC 20530.

    Dated: January 12, 2018. Jake Bishop-Green, Acting Department Clearance Officer for PRA, U.S. Department of Justice.
    [FR Doc. 2018-00837 Filed 1-18-18; 8:45 am] BILLING CODE 4410-14-P
    DEPARTMENT OF JUSTICE Bureau of Alcohol, Tobacco, Firearms and Explosives [OMB Number 1140-0068] Agency Information Collection Activities; Proposed eCollection eComments Requested; Police Check Inquiry—ATF F 8620.42 AGENCY:

    Bureau of Alcohol, Tobacco, Firearms and Explosives, Department of Justice.

    ACTION:

    Notice.

    SUMMARY:

    The Department of Justice, Bureau of Alcohol, Tobacco, Firearms and Explosives, is submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The proposed information collection was previously published in the Federal Register, on November 9, 2017, allowing for a 60-day comment.

    DATES:

    The Department of Justice encourages public comment and will accept input until February 20, 2018.

    FOR FURTHER INFORMATION CONTACT:

    If you have additional comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact John Dugan, Physical Security Programs Branch, either by mail at 99 New York Avenue NE, Washington, DC 20226 or by email at [email protected], or by telephone at 202-648-7540. Written comments and/or suggestions can also be sent to the Office of Management and Budget, Office of Information and Regulatory Affairs, Attention Department of Justice Desk Officer, Washington, DC 20503 or sent to [email protected]

    SUPPLEMENTARY INFORMATION:

    Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:

    —Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Bureau of Alcohol, Tobacco, Firearms and Explosives, including whether the information will have practical utility; —Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; —Evaluate whether and if so how the quality, utility, and clarity of the information to be collected can be enhanced; and —Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. Overview of This Information Collection

    1. Type of Information Collection: Revision of a currently approved collection.

    2. The Title of the Form/Collection: Police Check Inquiry.

    3. The agency form number, if any, and the applicable component of the Department sponsoring the collection: ATF F 8620.42. The applicable component within the Department of Justice is the Bureau of Alcohol, Tobacco, Firearms and Explosives.

    4. Affected public who will be asked or required to respond, as well as a brief abstract:

    Primary: Individuals or Households.

    Other (if applicable): Business or other for-profit.

    Abstract: The information requested is necessary to determine if individuals (potential contractors, task force officers, and volunteers) interested in providing services to ATF meet DOJ and ATF basic qualification requirements to be considered for access to ATF information, information technology systems, and/or facilities.

    5. An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: An estimated 1,000 respondents will utilize the form, and it will take each respondent approximately 5 minutes to complete the form.

    6. An estimate of the total public burden (in hours) associated with the collection: The reduction of respondents by 1,500, and burden hours by 175 respectively, is due to the elimination of Pre-Screening Qualifications Certification—ATF Form 8620.62 from this information collection.

    If additional information is required contact: Melody Braswell, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE, 3E.405A, Washington, DC 20530.

    Dated: January 12, 2018. Jake Bishop-Green, Acting Department Clearance Officer for PRA, U.S. Department of Justice.
    [FR Doc. 2018-00836 Filed 1-18-18; 8:45 am] BILLING CODE 4410-14-P
    DEPARTMENT OF JUSTICE Bureau of Alcohol, Tobacco, Firearms and Explosives [OMB Number 1140-0008] Agency Information Collection Activities; Proposed eCollection eComments Requested; Application and Permit for Permanent Exportation of Firearms (National Firearms Act)—ATF F 9 (5320.9) AGENCY:

    Bureau of Alcohol, Tobacco, Firearms and Explosives, Department of Justice.

    ACTION:

    Notice.

    SUMMARY:

    The Department of Justice, Bureau of Alcohol, Tobacco, Firearms and Explosives, is submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The proposed information collection was previously published in the Federal Register, on November 9, 2017, allowing for a 60-day comment.

    DATES:

    The Department of Justice encourages public comment and will accept input until February 20, 2018.

    FOR FURTHER INFORMATION CONTACT:

    If you have additional comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Kenneth Mason, Firearms and Explosives Services Specialist, either by mail at National Firearms Act Branch, 244 Needy Road, Martinsburg, WV 25405, by email at [email protected], or by telephone 304-616-4500. Written comments and/or suggestions can also be sent to the Office of Management and Budget, Office of Information and Regulatory Affairs, Attention Department of Justice Desk Officer, Washington, DC 20503 or sent to [email protected]

    SUPPLEMENTARY INFORMATION:

    Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:

    —Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Bureau of Alcohol, Tobacco, Firearms and Explosives, including whether the information will have practical utility; —Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; —Evaluate whether and if so how the quality, utility, and clarity of the information to be collected can be enhanced; and —Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. Overview of This Information Collection

    1. Type of Information Collection: Revision of a currently approved collection.

    2. The Title of the Form/Collection: Application and Permit for Permanent Exportation of Firearms (National Firearms Act).

    3. The agency form number, if any, and the applicable component of the Department sponsoring the collection: ATF F 9 (5320.9). The applicable component within the Department of Justice is the Bureau of Alcohol, Tobacco, Firearms and Explosives.

    4. Affected public who will be asked or required to respond, as well as a brief abstract:

    Primary: Business or other for-profit.

    Other (if applicable): Individuals or Households.

    Abstract: ATF Form 9 (5320.9) is typically used by a Federal firearms licensee who has paid the special (occupational) tax to deal, manufacture or import NFA firearms. The form must be filed (in quadruplicate) for approval to permanently export NFA firearms registered in the National Firearms Registration and Transfer Record. Once authorization has been granted, one copy is retained by ATF and the remaining copies returned to the exporter to establish that the exportation took place and claim relief from liability for the transfer tax.

    5. An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: An estimated 1,783 respondents will utilize the form, and it will take each respondent approximately 18 minutes to complete the form.

    6. An estimate of the total public burden (in hours) associated with the collection: The increase in respondents by 444, and burden hours by 134 respectively, are due to a general increase in the volume of industry submissions for this information collection.

    If additional information is required contact: Melody Braswell, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE, 3E.405A, Washington, DC 20530.

    Dated: January 12, 2018. Jake Bishop-Green, Acting Department Clearance Officer for PRA, U.S. Department of Justice.
    [FR Doc. 2018-00835 Filed 1-18-18; 8:45 am] BILLING CODE 4410-14-P
    DEPARTMENT OF JUSTICE Bureau of Alcohol, Tobacco, Firearms and Explosives [OMB Number 1140-0058] Agency Information Collection Activities; Proposed eCollection eComments Requested; Investigator Integrity Questionnaire—ATF F 8620.7 AGENCY:

    Bureau of Alcohol, Tobacco, Firearms and Explosives, Department of Justice.

    ACTION:

    30-day notice.

    SUMMARY:

    The Department of Justice (DOJ), Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), will submit the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The proposed information collection was previously published in the Federal Register, on November 15, 2017, allowing for a 60-day comment period.

    DATES:

    Comments are encouraged and will be accepted for an additional 30 days until February 20, 2018.

    FOR FURTHER INFORMATION CONTACT:

    If you have additional comments, particularly with respect to the estimated public burden or associated response time, have suggestions, need a copy of the proposed information collection instrument with instructions, or desire any other additional information, please contact Niki Wiltshire, Personnel Security Division either by mail at Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), Washington, DC 20226, or by telephone at 202-648-9260, or by email at [email protected] Written comments and/or suggestions can also be directed to the Office of Management and Budget, Office of Information and Regulatory Affairs, Attention Department of Justice Desk Officer, Washington, DC 20503 or sent to [email protected]

    SUPPLEMENTARY INFORMATION:

    Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:

    —Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; —Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; —Evaluate whether and if so how the quality, utility, and clarity of the information to be collected can be enhanced; and —Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

    Overview of this information collection:

    (1) Type of Information Collection: Extension, without change, of a currently approved collection.

    (2) The Title of the Form/Collection: Investigator Integrity Questionnaire.

    (3) The agency form number, if any, and the applicable component of the Department sponsoring the collection:

    Form number: ATF F 8620.7.

    Component: Bureau of Alcohol, Tobacco, Firearms and Explosives, U.S. Department of Justice.

    (4) Affected public who will be asked or required to respond, as well as a brief abstract:

    Primary: Individuals or households.

    Other: None.

    Abstract: ATF utilizes the services of contract investigators to conduct security/suitability investigations on prospective or current employees, as well as those contractors and consultants doing business with ATF. Persons interviewed by contract investigators will be randomly selected to voluntarily complete a questionnaire regarding the investigator's degree of professionalism.

    (5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: An estimated 2,500 respondents will utilize the form, and it will take each respondent approximately 5 minutes to complete the form.

    (6) An estimate of the total public burden (in hours) associated with the collection: The estimated annual public burden associated with this collection is 208 hours which is equal to 2,500 (# of respondents) * .083(5 minutes).

    If additional information is required contact: Melody Braswell, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE, 3E.405A, Washington, DC 20530.

    Dated: January 16, 2018. Melody Braswell, Department Clearance Officer for PRA, U.S. Department of Justice.
    [FR Doc. 2018-00882 Filed 1-18-18; 8:45 am] BILLING CODE 4410-14-P
    DEPARTMENT OF JUSTICE [OMB Number 1110-0045] Agency Information Collection Activities; Proposed eCollection eComments Requested; Extension With Change, of a Previously Approved Collection Customer Satisfaction Assessment Survey AGENCY:

    Federal Bureau of Investigation Laboratory, Department of Justice.

    ACTION:

    60-day notice.

    SUMMARY:

    The Department of Justice (DOJ), Federal Bureau of Investigation, Laboratory Division (LD), will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995.

    DATES:

    Comments are encouraged and will be accepted for 60 days until March 20, 2018.

    FOR FURTHER INFORMATION CONTACT:

    If you have additional comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Robin Ruth, Quality Manager, Federal Bureau of Investigation Laboratory, 2501 Investigation Parkway, Quantico, Virginia 22135.).

    SUPPLEMENTARY INFORMATION:

    Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:

    —Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Bureau of Justice Statistics, including whether the information will have practical utility; —Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; —Evaluate whether and if so how the quality, utility, and clarity of the information to be collected can be enhanced; and —Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. Overview of This Information Collection

    1. Type of Information Collection: Extension of a currently approved collection.

    2. The Title of the Form/Collection: Customer Satisfaction Assessment.

    3. The agency form number, if any, and the applicable component of the Department sponsoring the collection: The form number is FD-1000. The applicable component within the Department of Justice is the Federal Bureau of Investigation Laboratory.

    4. Affected public who will be asked or required to respond, as well as a brief abstract: Respondents primarily include federal, state, and local law enforcement. Respondents also include the intelligence community, Department of Defense, and international police agencies personnel and/or crime laboratory personnel. This collection is a brief questionnaire regarding contributors' satisfaction with the services provided by the Federal Bureau of Investigation Laboratory. This collection is needed to evaluate the quality of services provided by the Federal Bureau of Investigation Laboratory. The Federal Bureau of Investigation Laboratory is accredited by the American Society of Crime Laboratory Directors/Laboratory Accreditation Board (ASCLD/LAB) which recently merged with the ANSI-ASQ National Accreditation Board (ANAB). A requirement for maintaining accreditation is to evaluate the level of service provided by the Federal Bureau of Investigation Laboratory to our customers. To meet this requirement the Federal Bureau of Investigation Laboratory is requesting its customers to complete and return the Customer Satisfaction Assessment.

    5. An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: An estimated 1,000 respondents will complete the Customer Satisfaction Assessment survey in 2018. This estimate is based on the number of respondents in prior years of this collection. It is estimated that respondents will need 5 minutes to complete a questionnaire.

    6. An estimate of the total public burden (in hours) associated with the collection: The estimated public burden associated with this collection is 84 hours. It is estimated that respondents will need 5 minutes to complete a questionnaire. The burden hours for collecting respondent data sum to approximately 84 hours (1000 respondents × 5 minutes = 83.33 hours).

    If additional information is required contact: Melody Braswell, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE, 3E.405A, Washington, DC 20530.

    Dated: January 16, 2018. Melody Braswell, Department Clearance Officer for PRA, U.S. Department of Justice.
    [FR Doc. 2018-00906 Filed 1-18-18; 8:45 am] BILLING CODE 4410-02-P
    DEPARTMENT OF JUSTICE Notice of Lodging of Proposed Consent Decree Under the Comprehensive Environmental Response, Compensation, and Liability Act; and Federal Debt Collection Procedures Act

    On January 10, 2018, the Department of Justice lodged a proposed Consent Decree with the United States District Court for the Central District of California in the lawsuit entitled United States and California Department of Toxic Substances Control v. Jervis B. Webb Company and Jervis B. Webb Company of California, Civil Action No. 2:18-cv-234-ODW-JEM.

    The United States and the California Department of Toxic Substances Control filed this lawsuit asserting a claim under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) against the Jervis B. Webb Company of California (Webb-Cal) to recover costs incurred and to be incurred by the United States and the State of California in response to releases of hazardous substances at the Jervis Webb Superfund Site in South Gate, California (the “Site”). The United States also asserted a claim against the Jervis B. Webb Company (JBW), parent company of Webb-Cal, under the Federal Debt Collections Procedures Act (“FDCPA”) to recover assets transferred by Webb-Cal to JBW at a time when Webb-Cal was insolvent and indebted to the United States under CERCLA. Under the proposed Consent Decree, JBW will pay $3.45 million to the United States to resolve the claims of the United States. In exchange for this payment, both JBW and Webb-Cal will receive site-wide covenants not to sue and contribution protection under CERCLA, and JBW will receive a covenant not to sue for fraudulent conveyance under the FDCPA. Under this Consent Decree, California DTSC will receive $50,000 from JBW to resolve its claim under CERCLA against Webb-Cal.

    The publication of this notice opens a period for public comment on the Consent Decree. Comments should be addressed to the Assistant Attorney General, Environment and Natural Resources Division, and should refer to United States and California Department of Toxic Substances Control v. Jervis B. Webb Company and Jervis B. Webb Company of California, D.J. Ref. No. 90-11-3-10965. All comments must be submitted no later than thirty (30) days after the publication date of this notice. Comments may be submitted either by email or by mail:

    To submit comments: Send them to: By email [email protected] By mail Assistant Attorney General, U.S. DOJ—ENRD, P.O. Box 7611, Washington, DC 20044-7611.

    During the public comment period, the Consent Decree may be examined and downloaded at this Justice Department website: https://www.justice.gov/enrd/consent-decrees. We will provide a paper copy of the Consent Decree upon written request and payment of reproduction costs. Please mail your request and payment to: Consent Decree Library, U.S. DOJ—ENRD, P.O. Box 7611, Washington, DC 20044-7611.

    Please enclose a check or money order for $8.00 (25 cents per page reproduction cost) payable to the United States Treasury.

    Henry Friedman, Assistant Section Chief, Environmental Enforcement Section, Environment and Natural Resources Division.
    [FR Doc. 2018-00822 Filed 1-18-18; 8:45 am] BILLING CODE 4410-15-P
    DEPARTMENT OF JUSTICE Notice of Lodging of Proposed Consent Decree Under the Clean Air Act

    On January 10, 2018, the Department of Justice lodged a proposed Consent Decree (“Consent Decree”) with the United States District Court for the District of Connecticut in the lawsuit entitled United States v. Borough of Naugatuck and Naugatuck Environmental Technologies, LLC, Civil Action No. 3:18-cv-00051-vlbVLBIn a Complaint, the United States, on behalf of the U.S. Environmental Protection Agency (“EPA”), alleges that the Borough of Naugatuck, Connecticut (“Naugatuck”) and Naugatuck Environmental Technologies, LLC (“NET”) violated the Clean Air Act (the “Act”), 42 U.S.C. 7413, by violating: (1) The Solid Waste Combustion provisions in Section 129 of the Clean Air Act, 42 U.S.C. 7429, and (2) the Federal Plan Requirements for Sewage Sludge Incineration Units Constructed on or Before October 14, 2010, 40 CFR part 62, subpart LLL (“Subpart LLL”). The proposed Consent Decree in this case, among other things, requires that Naugatuck and NET bring the sewage sludge incineration unit located at the Naugatuck wastewater treatment facility into compliance with Subpart LLL, and pay a civil penalty of $100,000.

    The publication of this notice opens a period for public comment on the proposed Consent Decree. Comments should be addressed to the Assistant Attorney General, Environment and Natural Resources Division, and should refer to United States v. Borough of Naugatuck, CT and Naugatuck Environmental Technologies, LLC, D.J. Ref. No. 90-5-2-1-11589. All comments must be submitted no later than thirty (30) days after the publication date of this notice. Comments may be submitted either by email or by mail:

    To submit comments: Send them to: By email [email protected] By mail Assistant Attorney General, U.S. DOJ—ENRD, P.O. Box 7611, Washington, DC 20044-7611.

    During the public comment period, the proposed Consent Decree may be examined and downloaded at this Justice Department website: https://www.justice.gov/enrd/consent-decrees. We will provide a paper copy of the proposed Consent Decree upon written request and payment of reproduction costs. Please mail your request and payment to: Consent Decree Library, U.S. DOJ—ENRD, P.O. Box 7611, Washington, DC 20044-7611.

    Please enclose a check or money order for $9.50 (25 cents per page reproduction cost), payable to the United States Treasury.

    Jeffrey Sands, Assistant Chief, Environmental Enforcement Section, Environment & Natural Resources Division.
    [FR Doc. 2018-00833 Filed 1-18-18; 8:45 am] BILLING CODE 4410-15-P
    MERIT SYSTEMS PROTECTION BOARD Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery AGENCY:

    Merit Systems Protection Board.

    ACTION:

    Notice and request for comments.

    SUMMARY:

    The Merit Systems Protection Board (MSPB), as part of its continuing effort to reduce paperwork and respondent burden, is planning to submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB), entitled: “Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery” and identified by OMB Control No. 3124-0015, as required by the Paperwork Reduction Act of 1995 (PRA). This collection was developed as part of a Federal Government-wide effort to streamline the process for seeking feedback from the public on service delivery. MSPB is soliciting comments on this extension, without change, of a previously approved collection set to expire on April 30, 2018. The purpose of this notice is to allow 60 days for public comment preceding submission of the collection to the OMB.

    DATES:

    Consideration will be given to all comments received by March 20, 2018.

    ADDRESSES:

    Submit comments by using only one of the following methods:

    (1) Email. Submit comments to [email protected]

    (2) Mail. Submit comments to Jennifer Everling, Acting Clerk of the Board, Merit Systems Protection Board, 1615 M Street NW, Washington, DC 20419.

    (3) Fax. Submit comments to (202) 653-7130.

    All comments must reference OMB Control No. 3124-0015. Regardless of the method used for submitting comments or material, all submissions will be posted, without change, to MSPB's website (www.mspb.gov) and will include any personal information you provide. Therefore, submitting this information makes it public.

    FOR FURTHER INFORMATION CONTACT:

    Jennifer Everling, Acting Clerk of the Board, Merit Systems Protection Board, 1615 M Street NW, Washington, DC 20419; phone: (202) 653-7200; fax: (202) 653-7130; or email: [email protected] You may contact the Office of the Clerk of the Board for copies of the proposed collection of information at: [email protected]

    SUPPLEMENTARY INFORMATION:

    The proposed information collection activity provides a means to obtain qualitative customer and stakeholder feedback in an efficient, timely manner, in accordance with MSPB's commitment to improving service delivery. Qualitative feedback is information that provides useful insights on perceptions and opinions, but are not statistical surveys 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 MSPB and its customers and stakeholders. It will also allow feedback to contribute directly to the improvement of program management.

    The solicitation of feedback will target areas such as: Timeliness, appropriateness, accuracy of information, courtesy, efficiency of service delivery, and resolution of issues with service delivery. Responses will be assessed to plan and inform efforts to improve or maintain the quality of service offered to the public. If this information is not collected, vital feedback from customers and stakeholders on MSPB's services will be unavailable.

    The MSPB will only submit a collection for approval under this generic clearance if it meets the following conditions:

    • The collections are voluntary;

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

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

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

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

    • Information gathered will be used only internally for general service improvement and program management purposes and is not intended for release outside of MSPB;

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

    • Information gathered will yield qualitative information; the collections will not be designed or expected to yield statistically reliable results or used as though the results are generalizable to the population of study.

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

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

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

    OMB Number: 3124-0015.

    Type of Information Collection: Extension, without change, of a currently approved information collection.

    ICR Status: This ICR is currently scheduled to expire on April 30, 2018. 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.

    Abstract of Proposed Collection: This collection is part of a Federal Government-wide effort to streamline the process for seeking feedback from the public on service delivery and provides a means to obtain qualitative customer and stakeholder feedback in an efficient, timely manner, in accordance with MSPB's commitment to improving service delivery. Responses to any collection of information under this ICR are voluntary.

    Affected Public: Individuals and Households; Businesses and Organizations; State, Local or Tribal Government.

    Estimated Total Number of Respondents: 3,000.

    Estimated Frequency of Responses: Once per request.

    Estimated Total Average Number of Responses for Each Respondent: 1.

    Estimated Total Annual Burden Hours: 1,500.

    Estimated Total Cost: $50,100.

    Comments: Comments should be submitted as indicated in the ADDRESSES caption above. Comments are solicited to: (a) Evaluate whether the collection of information is necessary for the proper performance of the functions of MSPB, including whether the information shall have practical utility; (b) evaluate the accuracy of MSPB's estimate of the burden of the collection of information; (c) enhance the quality, utility, and clarity of the information to be collected; (d) minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) evaluate the estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information; and to transmit or otherwise disclose the information.

    Jennifer Everling, Acting Clerk of the Board.
    [FR Doc. 2018-00844 Filed 1-18-18; 8:45 am] BILLING CODE 7401-01-P
    NUCLEAR REGULATORY COMMISSION Advisory Committee on Reactor Safeguards; Notice of Meeting

    In accordance with the purposes of Sections 29 and 182b of the Atomic Energy Act (42 U.S.C. 2039, 2232b), the Advisory Committee on Reactor Safeguards (ACRS) will hold a meeting February 8-10, 2018, 11545 Rockville Pike, Rockville, Maryland 20852.

    Thursday, February 8, 2018, Conference Room T-2B1, 11545 Rockville Pike, Rockville, Maryland 20852

    8:30 a.m.-8:35 a.m.: Opening Remarks by the ACRS Chairman (Open)—The ACRS Chairman will make opening remarks regarding the conduct of the meeting.

    8:35 a.m.-10:30 a.m.: NuScale Design Certification Application Request for Exemption from General Design Criterion 27 (Open/Closed)—The Committee will hear briefings by and discussion with representatives of the NRC staff and NuScale regarding the subject exemption application. [Note: A portion of this session may be closed in order to discuss and protect information designated as proprietary, pursuant to 5 U.S.C 552b(c)(4)]

    10:45 a.m.-12:15 p.m.: WCAP-17938-P, Revision 2, “AP1000 In-Containment Cables and Non-Metallic Insulation Debris Integrated Assessment” (Open/Closed)—The Committee will hear briefings by and discussion with representatives of the NRC staff and Westinghouse regarding the subject generic safety issue. [Note: A portion of this session may be closed in order to discuss and protect information designated as proprietary, pursuant to 5 U.S.C 552b(c)(4)]

    1:15 p.m.-6:00 p.m.: Preparation of ACRS Reports (Open/Closed)—The Committee will continue its discussion of proposed ACRS reports. [Note: A portion of this session may be closed in order to discuss and protect information designated as proprietary, pursuant to 5 U.S.C 552b(c)(4)]

    Friday, February 9, 2018, Conference Room T-2B1, 11545 Rockville Pike, Rockville, Maryland 20852

    8:30 a.m.-10:00 a.m.: Future ACRS Activities/Report of the Planning and Procedures Subcommittee and Reconciliation of ACRS Comments and Recommendations (Open/Closed)—The Committee will hear discussion of the recommendations of the Planning and Procedures Subcommittee regarding items proposed for consideration by the Full Committee during future ACRS meetings. [Note: A portion of this meeting may be closed pursuant to 5 U.S.C. 552b(c)(2) and (6) to discuss organizational and personnel matters that relate solely to internal personnel rules and practices of the ACRS, and information the release of which would constitute a clearly unwarranted invasion of personal privacy]

    10:00 a.m.-12:00 p.m.: Biennial Review and Evaluation of the NRC Safety Research Program (Open)—The Committee will hear discussion regarding the NRC Safety Research Program.

    1:00 p.m.-6:00 p.m.: Preparation of ACRS Reports (Open/Closed)—The Committee will continue its discussion of proposed ACRS reports. [Note: A portion of this session may be closed in order to discuss and protect information designated as proprietary, pursuant to 5 U.S.C 552b(c)(4)]

    Saturday, February 10, 2018, Conference Room T-2B1, 11545 Rockville Pike, Rockville, Maryland 20852

    8:30 a.m.-12:00 p.m.: Preparation of ACRS Reports (Open/Closed)—The Committee will continue its discussion of proposed ACRS reports. [Note: A portion of this session may be closed in order to discuss and protect information designated as proprietary, pursuant to 5 U.S.C 552b(c)(4)]

    Procedures for the conduct of and participation in ACRS meetings were published in the Federal Register on October 4, 2017 (82 FR 46312). In accordance with those procedures, oral or written views may be presented by members of the public, including representatives of the nuclear industry. Persons desiring to make oral statements should notify Quynh Nguyen, Cognizant ACRS Staff (Telephone: 301-415-5844, Email: [email protected]), 5 days before the meeting, if possible, so that appropriate arrangements can be made to allow necessary time during the meeting for such statements. In view of the possibility that the schedule for ACRS meetings may be adjusted by the Chairman as necessary to facilitate the conduct of the meeting, persons planning to attend should check with the Cognizant ACRS staff if such rescheduling would result in major inconvenience.

    Thirty-five hard copies of each presentation or handout should be provided 30 minutes before the meeting. In addition, one electronic copy of each presentation should be emailed to the Cognizant ACRS Staff one day before meeting. If an electronic copy cannot be provided within this timeframe, presenters should provide the Cognizant ACRS Staff with a CD containing each presentation at least 30 minutes before the meeting.

    In accordance with Subsection 10(d) of Public Law 92-463 and 5 U.S.C. 552b(c), certain portions of this meeting may be closed, as specifically noted above. Use of still, motion picture, and television cameras during the meeting may be limited to selected portions of the meeting as determined by the Chairman. Electronic recordings will be permitted only during the open portions of the meeting.

    ACRS meeting agendas, meeting transcripts, and letter reports are available through the NRC Public Document Room at [email protected], or by calling the PDR at 1-800-397-4209, or from the Publicly Available Records System (PARS) component of NRC's document system (ADAMS) which is accessible from the NRC website at http://www.nrc.gov/reading-rm/adams.html or http://www.nrc.gov/reading-rm/doc-collections/ACRS/.

    Video teleconferencing service is available for observing open sessions of ACRS meetings. Those wishing to use this service should contact Mr. Theron Brown, ACRS Audio Visual Technician (301-415-6702), between 7:30 a.m. and 3:45 p.m. (ET), at least 10 days before the meeting to ensure the availability of this service. Individuals or organizations requesting this service will be responsible for telephone line charges and for providing the equipment and facilities that they use to establish the video teleconferencing link. The availability of video teleconferencing services is not guaranteed.

    Dated at Rockville, Maryland, this 16th day of January 2018.

    For the Nuclear Regulatory Commission.

    Russell E. Chazell, Advisory Committee Management Officer.
    [FR Doc. 2018-00933 Filed 1-18-18; 8:45 am] BILLING CODE 7590-01-P
    OVERSEAS PRIVATE INVESTMENT CORPORATION Sunshine Act: OPIC Annual Public Hearing TIME AND DATE:

    10:00 a.m., Thursday, March 8, 2018.

    PLACE:

    Offices of the Corporation, Twelfth Floor Board Room, 1100 New York Avenue NW, Washington, DC.

    STATUS:

    Hearing OPEN to the Public at 10 a.m.

    PURPOSE:

    Annual Public Hearing to afford an opportunity for any person to present views regarding the activities of the Corporation.

    PROCEDURES:

    Individuals wishing to address the hearing orally must provide advance notice to OPIC's Corporate Secretary no later than 5 p.m. Thursday, February 22, 2018. The notice must include the individual's name, title, organization, address, email, telephone number, and a concise summary of the subject matter to be presented.

    Oral presentations may not exceed ten (10) minutes. The time for individual presentations may be reduced proportionately, if necessary, to afford all participants who have submitted a timely request an opportunity to be heard.

    Participants wishing to submit a written statement for the record must submit a copy of such statement to OPIC's Corporate Secretary no later than 5 p.m. Thursday, February 22, 2018. Such statement must be typewritten, double-spaced, and may not exceed twenty-five (25) pages.

    Upon receipt of the required notice, OPIC will prepare an agenda for the hearing identifying speakers, setting forth the subject on which each participant will speak, and the time allotted for each presentation. The agenda will be available at the hearing.

    A written summary of the hearing will be compiled, and such summary will be made available, upon written request to OPIC's Corporate Secretary, at the cost of reproduction.

    CONTACT PERSON FOR INFORMATION:

    Information on the hearing may be obtained from Catherine F.I. Andrade at (202) 336-8768, or via email at [email protected]

    SUPPLEMENTARY INFORMATION:

    OPIC is a U.S. Government agency that provides, on a commercial basis, political risk insurance and financing in friendly developing countries and emerging democracies for environmentally sound projects that confer positive developmental benefits upon the project country while creating employment in the U.S. OPIC is required by section 231A(c) of the Foreign Assistance Act of 1961, as amended (the “Act”) to hold at least one public hearing each year.

    Dated: January 17, 2018. Catherine F.I. Andrade, OPIC Corporate Secretary.
    [FR Doc. 2018-01006 Filed 1-17-18; 11:15 am] BILLING CODE 3210-01-P
    SECURITIES AND EXCHANGE COMMISSION [Release No. 34-82498; File No. SR-NYSEAMER-2017-26] Self-Regulatory Organizations; NYSE American LLC; Order Approving a Proposed Rule Change To Amend Rule 971.1NY To Amend the Duration of a Customer Best Execution Auction January 12, 2018. I. Introduction

    On November 17, 2017, NYSE American LLC (“Exchange” or “NYSE American”) 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 amend Rule 971.1NY (Electronic Cross Transactions) to modify the parameters for the duration of a Customer Best Execution (“CUBE”) Auction. The proposed rule change was published for comment in the Federal Register on December 4, 2017.3 The Commission received no comment letters on the proposed rule change. This order approves the proposed rule change.

    1 15 U.S.C. 78s(b)(1).

    2 17 CFR 240.19b-4.

    3See Securities Exchange Act Release No. 82162 (November 28, 2017), 82 FR 57322 (“Notice”).

    II. Description of the Proposed Rule Change

    CUBE is a process by which an ATP Holder may electronically submit for execution an order it represents as agent (“CUBE Order”) against principal interest or against any other order it represents as agent.4 When the Exchange receives a valid CUBE Order for auction processing, a Request for Responses (“RFR”) detailing the series, the side of the market, the size of the CUBE Order, and the limit price of the CUBE Order is sent to all ATP Holders that subscribe to receive RFR messages. Currently, the amount of time given to ATP Holders to respond with competing interest to trade against the CUBE Order (“Response Time Interval”) is randomly set by the CUBE mechanism for each auction but cannot be shorter than 500 milliseconds or longer than 750 milliseconds, unless the auction is concluded early.5 The Exchange proposes to revise the Response Time Interval to provide that the duration of a CUBE Auction shall be a random period of time within parameters designated by the Exchange, which parameters shall be no less than 100 milliseconds and no more than one second.6 The proposal would require the Exchange to announce in advance, by Trader Update, any changes to the parameters.7

    4See Exchange Rule 971.1NY.

    5See Exchange Rule 971.1NY(c)(4)(A)-(F) (providing the scenarios that would result in the early termination of a CUBE Auction).

    6 The Exchange states that its proposal is consistent with exposure periods permitted in similar mechanisms on other options exchanges. See Notice, supra note 3, at 57323 n.5.

    7See id. at 57323.

    The Exchange states that the proposed rule change, among other things, would provide investors with more timely execution of their option orders while ensuring that there is an adequate exposure of orders in the CUBE mechanism; could provide more CUBE Orders an opportunity for price improvement by reducing market risk for ATP Holders that participate in CUBE Auctions; would give the Exchange flexibility in establishing the optimal duration of CUBE Auctions; and would encourage competition and thereby enhance the potential for price improvement.8

    8See id. at 57324.

    To substantiate that its members can receive, process, and communicate a response back to the Exchange within 100 milliseconds (the shortest possible duration of the Response Time Interval), the Exchange states that it surveyed all ATP Holders that responded to a CUBE Auction broadcast in the three months prior to the filing of this proposed rule change.9 According to the Exchange, each ATP Holder it surveyed indicated that it can receive, process, and communicate a response back to the Exchange within 100 milliseconds.10 The Exchange further states that it has analyzed its capacity and represents that it has the necessary systems capacity to handle the potential additional traffic associated with the additional transactions that may occur with the implementation of the proposed reduction of the Response Time Interval to no less than 100 milliseconds.11 The Exchange further represents that its system will be able to sufficiently maintain an audit trail for order and trade information with the reduction in the Response Time Interval.12

    9See id. at 57323.

    10See id.

    11See id.

    12See id.

    III. Discussion and Commission's Findings

    After careful review, the Commission finds that the proposed rule change is consistent with the requirements of the Act and the rules and regulations thereunder applicable to a national securities exchange.13 In particular, the Commission finds that the proposed rule change is consistent with Section 6(b)(5) of the Act,14 which requires, among other things, that the rules of a national securities exchange be designed to promote just and equitable principles of trade, to foster cooperation and coordination with persons engaged in regulating transactions in securities, to remove impediments to and perfect the mechanism of a free and open market and a national market system and, in general, to protect investors and the public interest, and not be designed to permit unfair discrimination between customers, issuers, brokers, or dealers. The Commission also finds that the proposed rule change is consistent with Section 6(b)(8) of the Act,15 which requires that the rules of an exchange not impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act.

    13 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).

    14 15 U.S.C. 78f(b)(5).

    15 15 U.S.C. 78f(b)(8).

    The Commission believes that, as NYSE American maintains, permitting the Exchange to designate an exposure time period of as short as100 milliseconds in the CUBE Auction is consistent with the Commission's past approval of rules of options exchanges that govern the duration of their electronic auctions. These rules provide for a period of as short as 100 milliseconds for market participants to submit responses to an auction announcement before the auction ends.16 Similarly, the Commission has approved rules allowing options exchanges to set an exposure period of up to one second.17

    16See Securities Exchange Act Release Nos. 76301 (October 29, 2015), 80 FR 68347 (November 4, 2015) (SR-BX-2015-032) (establishing an exposure period for Nasdaq BX's options price improvement mechanism (“PRISM”) of no less than 100 milliseconds and no more than one second); 77557 (April 7, 2016), 81 FR 21935 (April 13, 2016) (SR-Phlx-2016-40) (amending the exposure period for Nasdaq Phlx's Price Improvement XL (“PIXL”) to be no less than 100 milliseconds and no more than one second); 79733 (January 4, 2017), 82 FR 3055 (January 10, 2017) (SR-ISE-2016-26) (amending the exposure period for Nasdaq ISE's Price Improvement Mechanism (“PIM”) to be no less than 100 milliseconds and no more than one second); 80738 (May 22, 2017), 82 FR 24417 (May 26, 2017) (SR-CBOE-2017-029) (amending the exposure periods for CBOE's Automated Improvement Mechanism (“AIM”) and Solicitation Auction Mechanism (“SAM”) to be no less than 100 milliseconds and no more than one second); and 80940 (June 15, 2017), 82 FR 28369 (June 21, 2017) (SR-MIAX-2017-16) (amending the exposure periods for MIAX's Price Improvement Mechanism (“PRIME”) and PRIME Solicitation Mechanism to be no less than 100 milliseconds and no more than one second). See also the rules as codified at NASDAQ Phlx Rule 1080(n)(ii)(A)(4), NASDAQ BX Options Rules Chapter VI, Section 9(ii)(A)(3), Nasdaq ISE Rule 716, Supplementary Material .04, Nasdaq ISE Rule 723(c)(1), CBOE Rule 6.74A(b)(1)(C), CBOE Rule 6.74B(b)(1)(C), MIAX Rule 515A(a)(2)(i)(C), and MIAX Rule 515A(b)(2)(i)(C).

    17See supra note 16.

    The Commission notes that the fact that, in CUBE, a Response Time Interval is separately and randomly set by the auction mechanism for each individual auction (provided that no auction can be longer or shorter than specified limits) is not unique with respect to the instant proposal.18 The feature of CUBE that randomly sets a Response Time Interval for each auction—which is unique in contrast to electronic auction mechanisms at other options exchanges—has been a component of CUBE since approval of the Exchange's Rule governing the CUBE 19 and is consistent with the mechanism's current functionality.

    18 Currently, for example, the Response Time Interval for each individual auction is randomly set by the CUBE mechanism, but it is not possible for the mechanism to set a duration that is shorter than 500 milliseconds or longer than 750 milliseconds.

    19See Exchange Rule 971.1NY(c)(2)(B). See also Securities Exchange Act Release No. 72025 (April 25, 2014), 79 FR 24779, 24782, 24787 (May 1, 2017) (SR-NYSEMKT-2014-17) (order approving a proposed rule change to adopt the CUBE Auction).

    The Exchange's proposal revises how the minimum and maximum time lengths for the randomly-set Response Time Interval for each CUBE Auction would be established. Currently, Exchange Rule 971.1NY sets the minimum and maximum: no less than 500 milliseconds and no more than 750 milliseconds. Under the proposal, the Exchange is granted the discretion to establish the minimum and maximum possible durations of an auction and change them from time to time (with adequate notice to market participants). However, that discretion itself is restricted under the proposal. The Exchange would not be permitted to establish the limits in a way that would allow even a randomly-set Response Time Interval to be shorter than 100 milliseconds or longer than one second. The Commission thus notes that, under the proposed parameters, the exposure period for an order submitted to a CUBE Auction could never be shorter than the exposure period of any other options exchange's electronic auction.

    Accordingly, for the reasons discussed above, the Commission believes that the Exchange's proposal is consistent with the Act.

    IV. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the Act,20 that the proposed rule change (SR-NYSEAMER-2017-26) be, and hereby is, approved.

    20 15 U.S.C. 78s(b)(2).

    21 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.21

    Eduardo A. Aleman, Assistant Secretary.
    [FR Doc. 2018-00855 Filed 1-18-18; 8:45 am] BILLING CODE 8011-01-P
    SECURITIES AND EXCHANGE COMMISSION [Release No. 34-82502; File No. SR-OCC-2017-019] Self-Regulatory Organizations; The Options Clearing Corporation; Order Approving Proposed Rule Change, as Modified by Amendment No. 1, Concerning The Options Clearing Corporation's Adoption of a New Minimum Cash Requirement for the Clearing Fund January 12, 2018 I. Introduction

    The Options Clearing Corporation (“OCC”), on November 14, 2017, filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Exchange Act”) 1 and Rule 19b-4 thereunder,2 a proposed rule change (SR-OCC-2017-019) to propose a new minimum cash contribution requirement for its Clearing Fund 3 (“Cash Clearing Fund Requirement”) and also provide for the pass-through interest income earned on such deposits to its Clearing Members. On November 22, 2017, OCC filed Amendment No. 1 to the proposed rule change, which made clarifications regarding the calculation of the interest earned on deposits. The proposed rule change was published for comment in the Federal Register on December 1, 2017.4 The Commission received two comments regarding the proposed change.5 For the reasons discussed below, the Commission is approving the proposed rule change.

    1 15 U.S.C. 78s(b)(1).

    2 17 CFR 240.19b-4.

    3 Unless specified otherwise, capitalized terms shall have the meaning OCC ascribes in its By-Laws and Rules.

    4 Exchange Act Release No. 82156 (Nov. 27, 2017), 82 FR 57015 (Dec. 1, 2017) (SR-OCC-2017-019) (“Notice”).

    5 Two comment letters were submitted to the Commission expressing approval of the proposed rule change. See Letter from Rosa Beltran dated Nov. 28, 2017; Letter from Michael Kitlas dated Nov. 27, 2017.

    II. Description of the Proposed Rule Change

    OCC maintains a Clearing Fund, composed of contributions required to be made by all Clearing Members, to satisfy losses suffered by OCC under a number of circumstances, including the default or failure of a Clearing Member to meet any obligation for which OCC may be responsible in the exercise of its duties as a central counterparty. Presently, Article VIII, Section 3(a) of OCC's By-Laws provides that Clearing Fund contributions shall be in the form of cash and Government securities, but neither OCC's By-Laws nor Rules provides a minimum cash requirement for contributions to the Clearing Fund. Article VIII, Section 4(a) of OCC's By-Laws allows for OCC to invest cash contributions to the Clearing Fund, partially or wholly, in OCC's account in Government securities, and to the extent that such contributions are not so invested, they shall be deposited by OCC in a separate account or accounts for Clearing Fund contributions in approved custodians. Article VIII, Section 4(a) of OCC's By-Laws, however, presently does not account for the treatment of interest earned on cash deposits held in OCC's bank account at the Federal Reserve.

    A. Proposed Change To Establish the Cash Clearing Fund Requirement

    OCC proposed to establish a Cash Clearing Fund Requirement for its Clearing Fund to increase the amount of qualifying liquid resources available to OCC to account for the event there is an extreme scenario in the financial markets and OCC has to address any resultant liquidity demands. Further, the proposal sought to ensure that OCC holds, and maintains access to, a more consistent level of cash clearing fund resources in its available prefunded financial resources. Specifically, the proposed rule change would require that Clearing Members collectively contribute $3 billion in cash to the Clearing Fund. Each Clearing Member's proportionate share of the Cash Clearing Fund Requirement shall be determined by the current Clearing Fund allocation methodology in OCC Rule 1001.

    OCC's current liquidity resources are sized to cover historically observed liquidity demands and potential demands based on forecasts with a 12 month time horizon. The sizing calculations, in turn, are based on the potential exposure resulting from the default of a single clearing member. Further, the current clearing fund is sized, at a minimum, to ensure that OCC maintains sufficient collateral to access its committed liquidity facilities. OCC represented that it maintains committed liquidity facilities of $3 billion to cover its calculated historical and forecasted demands.6

    6See Exchange Act Release No. 81058 (June 30, 2017), 82 FR 31371 (July 6, 2017) (SR-OCC-2017-803); Exchange Act Release No. 76641 (Dec. 14, 2015), 80 FR 79114 (Dec. 18, 2015) (SR-OCC-2015-805). Both facilities allow OCC to obtain cash in exchange for Government securities 60 minutes after notice is given and collateral is posted.

    After analyzing its liquidity demands in extreme stress scenarios,7 OCC determined that it would propose the $3 billion Cash Clearing Fund Requirement to increase the amount and reliability of its liquid resources. OCC represented that, based upon its analysis, the peak stressed liquidity demands of the largest or two largest Clearing Members, which normally occur in conjunction with certain monthly expirations, could exceed the capacity of OCC's current committed liquidity facilities. Although OCC believes that it would be able to cover the resulting shortfall with cash already present in the Clearing Fund, OCC stated that it could not rely on such cash always being available because, under OCC's current By-Laws and Rules, there is no ability for OCC to ensure that a minimum amount of cash is maintained in the Clearing Fund at all times. As a result, OCC believes that the proposed $3 billion Cash Clearing Fund Requirement, combined with OCC's $3 billion of committed liquidity facilities, would provide liquid resources sufficient to cover the peak stressed liquidity demands of the largest one or two Clearing Members observed in the analysis.

    7 OCC represented that it performed an analysis of its stress liquidity demands based on a 1-in-70 year hypothetical market event. Specifically, OCC started its analysis by selecting the largest historical peak monthly settlements that occurred over the historical look-back period of data generated by the stress test system. It then also selected certain large non-expiration days to supplement the analysis. From this it estimated the mark-to-market and cash settled exercise and assignment obligations for the members driving the historical peak demand under the proposed stress tests scenario to determine the stressed peak demand.

    B. Proposed Change To Allow Temporary Increase of Cash Clearing Fund Requirement

    The proposed change would also provide authority for OCC to temporarily increase the amount of the Cash Clearing Fund Requirement. OCC's Executive Chairman, Chief Administrative Officer (“CAO”), or Chief Operating Officer (“COO”), would have the authority, upon providing notice to the Risk Committee, to temporarily raise the Cash Clearing Fund Requirement up to an amount that includes the size of the Clearing Fund as determined in accordance with Rule 1001 for the month in question. A Clearing Member will be required to satisfy any increase in its required cash contribution pursuant to an increase in the Cash Clearing Fund Requirement no later than one hour before the close of the Fedwire on the business day following OCC's issuance of an instruction to increase cash contributions.

    In such circumstances, the Risk Committee, by rule, would be obligated to review any such temporary increase as soon as practicable, but in any event within 20 calendar days of the increase. In its review, the Risk Committee shall determine whether (1) the increase in the minimum Cash Clearing Fund Requirement is no longer required, or (2) OCC's Clearing Fund contribution requirements and other related rules should be modified to ensure that OCC continues to maintain sufficient liquid resources to cover its largest aggregate payment obligations in extreme but plausible market conditions. In the event that the Risk Committee would determine to permanently increase the Cash Clearing Fund Requirement, OCC would initiate any regulatory approval process required to effect such a change.8

    8 However, OCC represented that it would not decrease the Cash Clearing Fund Requirement while the regulatory approvals for a change in the Cash Clearing Fund Requirement are being obtained to ensure that OCC continues to maintain sufficient liquid resources to cover its liquidity demands during that time.

    OCC acknowledged that increasing the Cash Clearing Fund Requirement could impose a liquidity constraint on its clearing members. Accordingly, OCC has proposed to limit the circumstances in which it could make such an increase. By rule, OCC would only be able to exercise this authority to protect OCC, its clearing members, or the general public. Further, any Cash Clearing Fund Requirement increase would have to: (i) Be based upon then-existing facts and circumstances, (ii) be in furtherance of the integrity of OCC and the stability of the financial system, and (iii) take into consideration the legitimate interests of Clearing Members and market participants.

    These changes would be reflected in new paragraph (a)(i) of Section 3 of Article VIII of OCC's By-Laws, as well as in new Interpretation and Policy .04 to Section 3 of Article VIII.

    C. Proposed Changes to Pass-Through Interest on Clearing Fund Cash to Clearing Members

    Under the proposal, OCC stated that substantially all the cash deposits in the Clearing Fund would be held in an account established by OCC at a Federal Reserve Bank. OCC proposes that it would pass the interest income earned in such account through to its Clearing Members. Specifically, OCC proposes to revise Article VIII, Section 4(a) of OCC's By-Laws to provide that any interest earned on cash deposits held at an account at the Federal Reserve shall accrue to the benefit of Clearing Members (calculated daily based on each Clearing Member's pro rata share of Clearing Fund cash deposits), provided that such Clearing Members have provided OCC with all tax documentation as OCC may from time to time require in order to effectuate such payment.

    To accommodate the pass through of interest income, OCC would also amend its Fee Policy to add definitions for “Pass-Through Interest Revenue” and “Operating Expenses” to exclude from the calculation of the Business Risk Buffer projected interest revenue and expense, respectively, related to the pass-through of earned interest from OCC to Clearing Members.9 OCC also proposes to add a new example of the Business Risk Buffer calculation reflecting this change and make clarifying changes throughout the policy to incorporate the use of the new defined terms. In addition, OCC proposes to amend the Fee Policy to remove references to “Proposed Rule 17Ad-22(e)(15)” to reflect the adoption of the Commission's Covered Clearing Agency Standards.

    9 While interest income earned by OCC from its bank account at the Federal Reserve would be passed on to its Clearing Members, OCC anticipates that it would charge a cash management fee to cover associated costs (i.e., administrative and similar costs). OCC would file a separate proposed rule change with the Commission, subject to receiving all necessary regulatory approvals for the proposed changes described herein, prior to implementing any cash management fee.

    D. Proposed Conforming Changes

    In conjunction with the aforementioned changes, OCC is also proposing to make four related conforming changes. First, OCC proposes to revise Interpretation and Policy .01 of Rule 1001 to reflect that the new minimum Clearing Fund size is $3 billion (instead of $1 billion) plus 110% of the size of OCC's committed liquidity facilities, which conforms to the Cash Clearing Fund Requirement. Second, OCC proposes to amend the definition of “Approved Custodian” in Article I, Section 1 of the By-Laws to clarify that the Federal Reserve Bank may also be an Approved Custodian, to the extent it is available to OCC. Third, OCC is proposing to delete existing Article VIII, Section 4(b), regarding the establishment of a segregated funds account for cash contributions to the Clearing Fund. The segregated funds account allows a Clearing Member to contribute cash to a bank or trust company account maintained in the name of OCC, subject to OCC's exclusive control, but the account also includes the name of the Clearing Member and any interest accrues to the Clearing Member rather than OCC. OCC proposes to eliminate this account type because Clearing Members have not expressed interest in using such an account, no such accounts are in use today, and moving forward, substantially all cash Clearing Fund contributions will held in OCC's account at the Federal Reserve Bank. Fourth, OCC proposes to introduce new language to Article VIII, Section 4(a) to clarify that cash contributions to the Clearing Fund that are deposited at approved custodians may be commingled with the Clearing Fund contributions of different Clearing Members.

    III. Discussion and Commission Findings

    Section 19(b)(2)(C) of the Exchange Act directs the Commission to approve a proposed rule change of a self-regulatory organization if it finds that such proposed rule change is consistent with the requirements of the Exchange Act and the rules and regulations thereunder applicable to such organization.10 After carefully considering the proposed rule change and the two comment letters submitted, the Commission finds that the proposed rule change is consistent with the requirements of the Exchange Act and the rules and regulations thereunder applicable to OCC. More specifically, the Commission finds that the proposal is consistent with Section 17A(b)(3)(F) of the Exchange Act and Rule 17Ad-22(e)(7) under the Exchange Act.11

    10 15 U.S.C. 78s(b)(2)(C).

    11 15 U.S.C. 78q-1(b)(3)(F); 17 CFR 240.17Ad-22(e)(7).

    A. Consistency With Section 17A(b)(3)(F) of the Exchange Act

    Section 17A(b)(3)(F) of the Exchange Act requires that the rules of a registered clearing agency be designed to do, among other things, promote the prompt and accurate clearance and settlement of securities transactions and, in general, protect investors and the public interest.12 Based on the analysis provided by OCC, the Commission believes that OCC's conclusion is reasonable, i.e., that under certain stressed conditions as set forth in the analysis, the peak stressed liquidity demands of the largest clearing member could exceed the size of OCC's committed liquidity facilities. Moreover, the Commission understands that OCC is unable to rely on the likelihood that there will always be deposits of cash in the Clearing Fund sufficient to cover such demands because, under its current By-laws and Rules, there is no ability for OCC to ensure that a minimum amount of cash is maintained in the Clearing Fund at all times. Therefore, there is a risk that OCC could face liquidity shortfalls in the event of a default by a clearing member whose payment obligations exceed OCC's liquid resources.

    12 15 U.S.C. 78q-1(b)(3)(F).

    OCC determined to address this risk by proposing to establish the Cash Clearing Fund Requirement. Establishing the Cash Clearing Fund Requirement would provide OCC with more qualifying liquid resources, which, in turn, enhances OCC's ability to cover payment obligations that could arise in stressed conditions. Therefore, the Commission believes that this outcome would enhance OCC's ability to manage its liquidity risk exposure, thereby promoting prompt and accurate clearance and settlement of securities transactions.

    Further, the proposal to give OCC the authority to temporarily increase the Cash Clearing Fund Requirement gives OCC additional means to address liquidity shortfalls in extreme scenarios. Therefore, the Commission believes that increasing the amount of cash, and thus the overall amount of qualifying liquid resources, available to cover OCC's liquidity demands arising in stressed scenarios is consistent with the promotion of prompt and accurate clearance and settlement of securities transactions.

    OCC is the sole registered clearing agency for the U.S. listed options markets. As such, it is important for OCC to implement measures that enhance its ability to manage risks that could cause a financial loss or settlement disruption and threaten the stability of the U.S. listed options markets and the broader financial system. The Commission believes that the proposed change is designed to enhance OCC's ability to continue to make timely settlement of payment obligations and otherwise service the U.S. options markets while in the midst of experiencing an extreme market event in the form of the default of up to two of its largest clearing members. As such, the Commission believes the proposed change is consistent with the protection of investors and the public interest.

    Accordingly, the Commission finds that the proposed rule change is consistent with Section 17A(b)(3)(F) of the Exchange Act.13

    13 15 U.S.C. 78q-1(b)(3)(F).

    B. Consistency With Rule 17Ad-22(e)(7) of the Exchange Act

    The Commission further believes that the proposed change is consistent with Rule 17Ad-22(e)(7) under the Exchange Act, which requires that a covered clearing agency establish, implement, maintain and enforce written policies and procedures reasonably designed to effectively measure, monitor, and manage its liquidity risk.14 This includes measuring, monitoring, and managing the covered clearing agency's settlement and funding flows on an ongoing and timely basis, as well as its use of intraday liquidity.15 The Commission believes that the proposed change is consistent with several particular sub-parts of Rule 17Ad-22(e)(7), which require that OCC's liquidity risk management policies and procedures be reasonably designed to achieve the following:

    14 17 CFR 240.17Ad-22(e)(7).

    15 17 CFR 240.17Ad-22(e)(7).

    • Maintaining sufficient liquid resources at the minimum in all relevant currencies to effect same-day and, where appropriate, intraday and multiday settlement of payment obligations with a high degree of confidence under a wide range of foreseeable stress scenarios that includes, but is not limited to, the default of the participant family that would generate the largest aggregate payment obligation for the covered clearing agency in extreme but plausible market conditions; 16

    16 17 CFR 240.17Ad-22(e)(7)(i).

    • using the access to accounts and services at a Federal Reserve Bank or other relevant central bank, when available and where the board of directors of the covered clearing agency has determined that it would be practical to enhance its management of liquidity risk;17 and

    17 17 CFR 240.17Ad-22(e)(7)(iii).

    • addressing foreseeable liquidity shortfalls that would not be covered by a covered clearing agency's liquid resources and seeking to avoid unwinding, revoking, or delaying the same-day settlement of payment obligations.18

    18 17 CFR 240.17Ad-22(e)(7)(viii).

    By proposing the Cash Clearing Fund Requirement and increasing the amount of qualifying liquid resources available to cover OCC's liquidity demands arising in stressed scenarios, OCC has taken measures consistent with the requirement in Rule 17Ad-22(e)(7)(i) that it maintain sufficient liquid resources to effect settlement of its payment obligations with a high degree of confidence under a wide range of foreseeable stress scenarios. OCC also represented that substantially all of OCC's Clearing Fund deposits consisting of cash would be held in an account established by OCC at a Federal Reserve Bank and further clarified that interest earned in such an account would be paid to its members on a specified basis. By proposing to use its access to accounts at a Federal Reserve Bank to support the maintenance of the Cash Clearing Fund Requirement, OCC has taken measures consistent with the requirement in Rule 17Ad-22(e)(7)(iii) which provides for using access to a central bank account, where available and determined to be practical. Further, the proposed authority to temporarily increase the Cash Clearing Fund Requirement is intended to allow OCC to address a foreseeable liquidity shortfall and is therefore consistent with the requirement in Rule 17Ad-22(e)(7)(viii) addressing such shortfalls.

    IV. Conclusion

    On the basis of the foregoing, the Commission finds that the proposed change is consistent with the requirements of the Exchange Act, and in particular, with the requirements of Section 17A of the Exchange Act 19 and the rules and regulations thereunder.

    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).

    It is therefore ordered pursuant to Section 19(b)(2) of the Exchange Act that the proposed rule change (SR-OCC-2017-019), as modified by Amendment No.1, be, and hereby is, approved.

    For the Commission by the Division of Trading and Markets, pursuant to delegated authority.20

    Brent J. Fields, Secretary.

    20 17 CFR 200.30-3(a)(12).

    [FR Doc. 2018-00858 Filed 1-18-18; 8:45 am] BILLING CODE 8011-01-P
    SECURITIES AND EXCHANGE COMMISSION [Release No. 34-82494; File No. SR-NSCC-2017-020] Self-Regulatory Organizations; National Securities Clearing Corporation; Notice of Filing of a Proposed Rule Change To Enhance the Calculation of the Volatility Component of the Clearing Fund Formula That Utilizes a Parametric Value-at-Risk Model and Eliminate the Market Maker Domination Charge January 12, 2018.

    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934, as amended (“Act”) 1 and Rule 19b-4 thereunder,2 notice is hereby given that on December 28, 2017, National Securities Clearing Corporation (“NSCC”) filed with the Securities and Exchange Commission (“Commission”) the proposed rule change as described in Items I, II and III below, which Items have been prepared by the clearing agency.3 The Commission is publishing this notice to solicit comments on the proposed rule change from interested persons.

    1 15 U.S.C. 78s(b)(1).

    2 17 CFR 240.19b-4.

    3 On December 28, 2017, NSCC filed this proposed rule change as an advance notice (SR-NSCC-2017-808) with the Commission pursuant to Section 806(e)(1) of Title VIII of the Dodd-Frank Wall Street Reform and Consumer Protection Act entitled the Payment, Clearing, and Settlement Supervision Act of 2010 (“Clearing Supervision Act”), 12 U.S.C. 5465(e)(1), and Rule 19b-4(n)(1)(i) of the Act, 17 CFR 240.19b-4(n)(1)(i). A copy of the advance notice is available at http://www.dtcc.com/legal/sec-rule-filings.

    I. Clearing Agency's Statement of the Terms of Substance of the Proposed Rule Change

    The proposed rule change of NSCC consists of modifications to NSCC's Rules & Procedures (“Rules”) 4 in order to enhance the calculation of the volatility component of the Clearing Fund formula that utilizes a parametric Value-at-Risk (“VaR”) model (“VaR Charge”) by (1) adding an additional calculation utilizing the VaR model that incorporates an evenly-weighted volatility estimation, which would supplement the current calculation that utilizes the VaR model but incorporates an exponentially-weighted moving average (“EWMA”) volatility estimation,5 where the higher of the two calculations would be the core parametric result (“Core Parametric Estimation”); and (2) introducing two additional formulas to the calculation of the VaR Charge—the Gap Risk Measure and the Portfolio Margin Floor, where the results of these two calculations would be compared to the Core Parametric Estimation and the highest of the three would be a Member's final VaR Charge, as described in greater detail below.

    4 Capitalized terms not defined herein are defined in the Rules, available at http://dtcc.com/~/media/Files/Downloads/legal/rules/nscc_rules.pdf.

    5 As described in greater detail in the filing, an EWMA volatility estimation is an estimation of volatility that gives more weight to most recent market observations, where an evenly-weighted volatility estimation is an estimation of volatility that gives even weight to historic market observations.

    NSCC is also proposing to eliminate the existing Market Maker Domination component (“MMD Charge”) from the Clearing Fund formula, as described in greater detail below.

    II. Clearing Agency's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the clearing agency included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The clearing agency 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 1. Purpose

    NSCC is proposing to enhance the calculation of the VaR Charge by introducing an additional estimation of volatility that would be incorporated into the VaR model, and introducing two additional calculations, the Gap Risk Measure and the Portfolio Margin Floor, that NSCC believes would collectively enhance its ability to mitigate market price risk. NSCC currently calculates the VaR Charge by applying a parametric VaR model that incorporates an EWMA volatility estimation. NSCC is proposing to introduce an additional calculation that also applies the parametric VaR model but replaces the EWMA volatility estimation with an evenly-weighted volatility estimation.6 The result of these two calculations using the parametric VaR model would be compared and the higher of the two would be the Core Parametric Estimation.

    6See id.

    NSCC is also proposing to introduce two additional calculations to arrive at a final VaR Charge, the Gap Risk Measure and the Portfolio Margin Floor. NSCC would use the highest result between the Core Parametric Estimation, the Gap Risk Measure, when applicable, and the Portfolio Margin Floor calculations as a Member's final VaR Charge.7

    7 NSCC may calculate Members' VaR Charge on an intraday basis for purposes of monitoring the risks presented by Members' activity. These calculations would be also be performed using the proposed enhanced methodology.

    Each of the separate calculations would provide NSCC with a measure of the market price risk presented by the Net Unsettled Positions and Net Balance Order Unsettled Positions (for purposes of this filing, referred to collectively herein as “Net Unsettled Positions”) 8 in a Member's portfolio. Collectively, the proposed enhancements to the calculation of the VaR Charge would permit NSCC to more effectively cover its credit exposures and produce margin levels commensurate with the risks and particular attributes of each Member's portfolio, as described in greater detail below.

    8 “Net Unsettled Positions” and “Net Balance Order Unsettled Positions” refer to net positions that have not yet passed their settlement date, or did not settle on their settlement date. See Procedure XV (Clearing Fund Formula and Other Matters) of the Rules, supra note 4.

    NSCC is also proposing to eliminate the existing MMD Charge from the Clearing Fund formula. When the MMD Charge was first introduced, it was developed to only address concentration risks presented by Net Unsettled Positions in certain securities that are traded by firms that are designated Market Makers, as described in greater detail below. Given this limited scope of application of this charge, and because NSCC believes it more effectively addresses the risks this charge was designed to address through other risk management measures, including the proposed Gap Risk Measure calculation of the VaR Charge, NSCC is proposing to eliminate the MMD Charge.

    Each of these proposed changes is described in more detail below.

    (i) Overview of the Required Deposit and NSCC's Clearing Fund

    As part of its market risk management strategy, NSCC manages its credit exposure to Members by determining the appropriate Required Deposits to the Clearing Fund and monitoring its sufficiency, as provided for in the Rules.9 The Required Deposit serves as each Member's margin. The objective of a Member's Required Deposit is to mitigate potential losses to NSCC associated with liquidation of such Member's portfolio in the event that NSCC ceases to act for such Member (hereinafter referred to as a “default”).10 The aggregate of all Members' Required Deposits constitutes the Clearing Fund of NSCC, which it would access should a defaulting Member's own Required Deposit be insufficient to satisfy losses to NSCC caused by the liquidation of that Member's portfolio.

    9See Rule 4 (Clearing Fund) and Procedure XV (Clearing Fund Formula and Other Matters), supra note 4. NSCC's market risk management strategy is designed to comply with Rule 17Ad-22(e)(4) under the Act, where these risks are referred to as “credit risks.” 17 CFR 240.17Ad-22(e)(4).

    10 The Rules set out the circumstances under which NSCC may cease to act for a Member and the types of actions it may take. For example, NSCC may suspend a firm's membership with NSCC or prohibit or limit a Member's access to NSCC's services in the event that Member defaults on a financial or other obligation to NSCC. See Rule 46 (Restrictions on Access to Services) of the Rules, supra note 4.

    Pursuant to NSCC's Rules, each Member's Required Deposit amount consists of a number of applicable components, each of which is calculated to address specific risks faced by NSCC, as identified within Procedure XV of the Rules.11 The volatility component of each Member's Required Deposit is designed to measure market price volatility and is calculated for Members' Net Unsettled Positions. The volatility component is designed to capture the market price risk associated with each Member's portfolio at a 99th percentile level of confidence. The VaR Charge is the volatility component applicable to most Net Unsettled Positions,12 and usually comprises the largest portion of a Member's Required Deposit. Procedure XV of the Rules currently provides that the VaR Charge shall be calculated in accordance with a generally accepted portfolio volatility margin model utilizing assumptions based on reasonable historical data and an appropriate volatility range.13 As such, NSCC currently calculates a Member's VaR Charge utilizing the VaR model, which incorporates an EWMA volatility estimation.

    11Supra note 4.

    12 As described in Procedure XV, Section I(A)(1)(a)(ii) and (iii) and Section I(A)(2)(a)(ii) and (iii) of the Rules, Net Unsettled Positions in certain securities are excluded from the VaR Charge and instead charged a volatility component that is calculated by multiplying the absolute value of those Net Unsettled Positions by a percentage. Supra note 4.

    13 Procedure XV, Section I(A)(1)(a)(i) and Section I(A)(2)(a)(i) of the Rules, supra note 4.

    Currently, Members' Required Deposits may also include an MMD Charge, applicable only to Members that are Market Makers and Members that clear for Market Makers.14 As described in greater detail below, the MMD Charge is imposed when these Members hold a Net Unsettled Position that is greater than 40 percent of the overall unsettled long position (sum of each clearing broker's net long position) in that security in the Continuous Net Settlement (“CNS”) system.15

    14 As used herein, “Market Maker” means a member firm of the Financial Industry Regulatory Authority, Inc. (“FINRA”) that is registered by FINRA as a Market Maker pursuant to FINRA's rules, available at http://finra.complinet.com/en/display/display.html.

    15See Rule 11 (CNS System) and Procedure VII (CNS Accounting Operation), supra note 4.

    NSCC employs daily backtesting to determine the adequacy of each Member's Required Deposit. NSCC compares the Required Deposit 16 for each Member with the simulated liquidation gains/losses using the actual positions in the Member's portfolio, and the historical security returns. NSCC investigates the cause(s) of any backtesting deficiencies. As part of this investigation, NSCC pays particular attention to Members with backtesting deficiencies that bring the results for that Member below the 99 percent confidence target (i.e., greater than two backtesting deficiency days in a rolling twelve-month period) to determine if there is an identifiable cause of repeated backtesting deficiencies.

    16 For backtesting comparisons, NSCC uses the Required Deposit amount without regard to the actual collateral posted by the Member.

    Further, as a part of its model performance review, and consistent with its regulatory requirements, NSCC regularly assesses its risks as they relate to its model assumptions, parameters, and sensitivities, including those of its parametric VaR model, to evaluate whether margin levels are commensurate with the particular risk attributes of each relevant product, portfolio, and market.17 As part of NSCC's model performance monitoring, NSCC management analyzes and evaluates the continued effectiveness of its parametric VaR model in order to identify any weaknesses, and determine whether, and which, enhancements may be necessary to its formulas, parameters or assumptions to improve margin coverage.

    17See 17 CFR 240.17Ad-22(e)(6)(i), (vi).

    The proposed changes to the calculation of the VaR Charge, described below, are a result of NSCC's regular review of the effectiveness of its margining methodology.

    (ii) Enhancements to the VaR Charge

    Adding an Evenly-Weighted Volatility Estimation to the VaR Model. To calculate the VaR Charge, NSCC uses a parametric VaR model that currently only incorporates an EWMA volatility estimation. The EWMA volatility estimation is considered front-weighted as it assigns more weight to most recent market observations based on the assumption that the most recent price history would have more relevance to, and therefore is a better measure of, current market price volatility levels. A calculation using this EWMA volatility estimation is responsive to changing market volatility, and, because NSCC's Member-level model backtesting results have generally remained above a 99th percentile level of confidence over a 10-year performance window, NSCC believes this calculation continues to be an effective measurement of price volatility for the majority of Net Unsettled Positions that are subject to the VaR Charge. More specifically, NSCC believes its backtesting results show that this calculation has been proven to be effective for calculating the price volatility of large diversified portfolios, which represent the majority of Net Unsettled Positions that are subject to the VaR Charge.

    However, NSCC believes this calculation may not adequately cover a rapid change in market price volatility levels, including, for example, a drop in portfolio volatility in a stabilizing market. Additionally, NSCC has observed poorer backtesting coverage for those Members with less diversified portfolios in atypical market conditions.

    In estimating volatility, the EWMA volatility estimation gives greater weight to more recent market observations, and effectively diminishes the value of older market observations. However, volatility in equity markets often rapidly revert to pre-volatile levels, and then are followed by a subsequent spike in volatility. So, while a calculation that relies exclusively on the EWMA volatility estimation can capture changes in volatility that emerge from a progressively calm or non-volatile market, it may cause a reactive decrease in margin that does not adequately capture the risks related to a rapid shift in market price volatility levels. Alternatively, an evenly-weighted volatility estimation would continue to give even weight to all historical volatility observations in the look-back period (described below), and would prevent margin from decreasing too quickly.

    Therefore, in order to more adequately cover a rapid change in market price volatility levels and the risks presented by less diversified portfolios in its calculation of the VaR Charge, NSCC is proposing to add another calculation of the VaR Charge utilizing its parametric VaR model that would incorporate an evenly-weighted volatility estimation. NSCC believes an additional calculation using a volatility estimation that gives even weight to market observations over a set look-back period would allow it to more adequately address risks related to a rapid shift in general market price volatility levels, which can occur as a result of either idiosyncratic, issuer events (also referred to as “gap risk events”),18 or are due to specific characteristics of a Member's portfolio based on their size, balance, direction, concentration, or the degree of correlation with broad market returns.

    18 Gap risk events may include, for example, earning reports, management changes, merger announcements, insolvency, or other unexpected, issuer-specific events.

    The proposed calculation incorporating an evenly-weighted volatility estimation would give equal weight to price observations over a look-back period of at least 253 days. NSCC analyzed the impact of using a look-back period of various lengths and determined that a look-back period of at least 253 days would provide NSCC with an adequate view of recent, past market observations in estimating volatility to meet its backtesting performance targets, and wouldn't result in unnecessarily high margin calculations. NSCC would weigh these considerations periodically to determine an appropriate look-back period that is at least 253 days.

    NSCC would perform both calculations using the parametric VaR model—one using the existing EWMA volatility estimation and an additional calculation using the proposed evenly-weighted volatility estimation—and would use the highest result of these calculations as the Core Parametric Estimation in connection with calculating a Member's VaR Charge. NSCC believes that, while the existing EWMA calculation provides adequate responsiveness to increasing market volatility, as described above, the proposed evenly-weighted calculation would be better at covering the risk of a rapid change in market volatility levels by retaining market observations from the entire historical data set. Therefore, by using both calculations and selecting the higher result, NSCC would be able to more effectively cover its credit exposures and mitigate the risk presented by different market conditions in arriving at a final Core Parametric Estimation.

    In order to implement the proposed change, NSCC would amend Procedure XV of the Rules by creating a new subjection (I) to Sections I(A)(1)(a)(i) and I(A)(2)(a)(i) of the Rules, which would define the Core Parametric Estimate as the higher result of two calculations—and EWMA calculation and the proposed evenly-weighted calculation—both utilizing the parametric VaR model.

    Gap Risk Measure. NSCC is also proposing to introduce the Gap Risk Measure as an additional calculation that, when applicable, would be used to determine a Member's final VaR Charge.

    The proposed Gap Risk Measure would be calculated to address the risks presented by a portfolio that is more susceptible to the effects of gap risk events due to the idiosyncratic nature of the Net Unsettled Positions in that portfolio. For example, the proposed calculation would address the risk that a gap risk event affects the price of a security in which a portfolio holds a Net Unsettled Position that represents more than a certain percent of the entire portfolio's value, such that the event could impact the entire portfolio's value. The proposed Gap Risk Measure would supplement the calculation of the Core Parametric Estimation because a parametric VaR model calculation is not designed to fully capture this specific risk presented by a concentrated position in a Member's portfolio.

    The proposed Gap Risk Measure would only be applied for a Member if the Net Unsettled Position with the largest absolute market value in the portfolio represents more than a certain percent of the entire portfolio's value (“concentration threshold”). NSCC is proposing a concentration threshold to the application of the Gap Risk Measure because its backtesting results have shown that portfolios with a Net Unsettled Position that represents a proportional value of the entire portfolio over 30 percent tend to have backtesting coverage below the target 99 percent confidence level. These results also show that these portfolios are more susceptible to the effects of gap risk events that the proposed calculation is designed to measure. Therefore, NSCC would only apply the Gap Risk Measure charge if the Net Unsettled Position with the largest absolute market value in a Member's portfolio represents more than 30 percent of that Member's entire portfolio value. NSCC would set 30 percent as the ceiling for the concentration threshold, and would evaluate the threshold periodically based on the Member's backtesting results during a time period of not less than the previous twelve months to determine if it may be appropriate to the threshold at a lower percent.

    Additionally, NSCC believes the risk of large, unexpected price movements, particularly those caused by a gap risk event, may have a greater impact on portfolios with large Net Unsettled Positions in securities that are susceptible to those events. Generally, index-based exchange-traded funds track closely to similar equity indices and are less prone to the effects of gap risk events. As such, if the concentration threshold is met, NSCC would calculate the Gap Risk Measure for Net Unsettled Positions in the portfolio, other than positions in index-based exchange traded funds (referred to herein for ease of reference as “non-index Net Unsettled Positions”).19

    19 NSCC would use a third-party market provider to identify index-based exchange-traded funds. The third-party market provider would identify index-based exchange-traded funds as those with criteria that requires the portfolio returns to track to a broad market index. Exchange-traded funds that do not meet this criteria would not be considered index-based exchange-traded funds and would be included the Gap Risk Measure calculation.

    When applicable, NSCC would calculate the Gap Risk Measure by multiplying the gross market value of the largest non-index Net Unsettled Position in the portfolio by a percent of not less than 10 percent.20 NSCC would determine such percent empirically as no less than the larger of the 1st and 99th percentiles of three-day returns of a set of CUSIPs that are subject to the VaR Charge pursuant to the Rules,21 giving equal rank to each to determine which has the highest movement over that three-day period. NSCC would use a look-back period of not less than ten years that includes a one-year stress period.22 If the one-year stress period overlaps with the look-back period, only the non-overlapping period would be combined with the look-back period. The result would then be rounded up to the nearest whole percentage.

    20 NSCC believes it is prudent to set a floor for the Gap Risk Measure charge, and has determined that a floor of 10 percent would appropriately align this charge with the charge that is applied to Net Unsettled Positions in certain securities that are excluded from the VaR Charge and instead charged a similar haircut-based volatility component. See supra note 12.

    21Supra note 12.

    22 NSCC believes using a look-back period of not less than ten years that includes a one-year stress period would provide it with a stable risk measurement that incorporates a sufficient look-back period that would be appropriate for purposes of determining the appropriate percent to use in the calculation of the Gap Risk Measure.

    By calculating this charge as a percent of the gross market value of the largest non-index Net Unsettled Position that exceeds the set threshold, NSCC believes the proposed Gap Risk Measure would allow it to capture the risk that a gap risk event affects the price of a security in which the Member holds a concentrated position and, due to the disproportionate value of this position in the Member's portfolio, the impact of that event affects the entire portfolio. This calculation, as an additional measure for the VaR Charge, would permit NSCC to assess an adequate amount of margin to cover the gap risks not captured by the parametric VaR model calculations. As such, the proposed calculation would contribute to NSCC's goal of producing margin levels commensurate with the risks and particular attributes of each Member's portfolio.

    In order to implement this proposed change, NSCC would amend Procedure XV of the Rules by creating a new subjection (II) to Sections I(A)(1)(a)(i) and I(A)(2)(a)(i) of the Rules, which would describe the calculation of the Gap Risk Measure.

    Portfolio Margin Floor. NSCC is also proposing to introduce the Portfolio Margin Floor as an additional calculation that, when applicable, would be used to determine a Member's final VaR Charge.

    The proposed Portfolio Margin Floor would be calculated to address risks that may not be adequately accounted for in the other calculations of the VaR Charge by operating as a floor to, or minimum amount of, the final VaR Charge. A parametric VaR model may result in a low VaR Charge for balanced portfolios. For example, in circumstances where the gross market value of a Member's Net Unsettled Positions is high and the cost of liquidation in the event that Member defaults could also be high, the parametric VaR model may not adequately measure the potential costs of liquidation. The proposed charge would be based on the balance and direction of Net Unsettled Positions in the Members' portfolio and is designed to be proportional to the market value of the portfolio. In this way, the Portfolio Margin Floor would allow NSCC to more effectively cover its credit exposures.

    The Portfolio Margin Floor would be the sum of two separate calculations, both of which would measure the market value of the portfolio based on the direction of Net Unsettled Positions in that portfolio. In this way, the calculation would effectively set a floor on the VaR Charge based on the composition of the portfolio and would mitigate the risk that low price volatility in portfolios with either large gross market values or large net directional market values could hinder NSCC's ability to effectively liquidate or hedge the Member's portfolio in three business days.

    First, NSCC would calculate the net directional market value of the portfolio by calculating the absolute difference between the market value of the long Net Unsettled Positions and the market value of the short Net Unsettled Positions in the portfolio,23 and then multiplying that amount by a percentage. Such percentage would be determined by examining the annual historical volatility levels of benchmark equity indices over a historical look-back period, as a standard and generally accepted reference that incorporates sufficient data history. Second, NSCC would calculate the balanced market value of the portfolio by taking the lowest market value of either (i) the long Net Unsettled Positions, or (ii) the short Net Unsettled Positions in the portfolio,24 and then multiplying that value by a percentage. Such percentage would generally be a fraction of the percentage used in the calculation of the net directional market value of the portfolio and would be an amount that covers the transaction costs and other basis risks present for the Net Unsettled Positions in that portfolio.25

    23 For example, if the market value of the long Net Unsettled Positions is $100,000, and the market value of the short Net Unsettled Positions is $200,000, the net directional market value of the portfolio is $100,000.

    24 For example, if the market value of the long Net Unsettled Positions is $100,000, and the market value of the short Net Unsettled Positions is $110,000, the balanced market value of the portfolio is $100,000.

    25 NSCC would use a third-party market provider to identify these transaction costs and other basis risks.

    NSCC would add the results of these two calculations to arrive at the final Portfolio Margin Floor amount. The sum of these two calculations would provide a minimum VaR Charge by effectively establishing a margin floor for certain portfolios that may not be effectively assessed in the other calculations of the VaR Charge. NSCC would compare the Portfolio Margin Floor result with the Gap Risk Measure, when applicable, and the Core Parametric Estimation and would use the highest of the three calculations as the final VaR Charge for each Member, as applicable.

    In order to implement this proposed change, NSCC would amend Procedure XV of the Rules by creating a new subjection (III) to Sections I(A)(1)(a)(i) and I(A)(2)(a)(i) of the Rules, which would describe the calculation of the Portfolio Margin Floor.

    (iii) Eliminating the MMD Charge

    Finally, NSCC is proposing to eliminate the MMD Charge from its Clearing Fund calculation. The MMD Charge is an existing component of the Clearing Fund formula and is calculated for Members that are Market Makers and Members that clear for Market Makers.26 The charge was introduced during a period of rapid growth in the adaptation of the internet, and was developed to address the risks presented by concentrated positions held specifically by Market Makers. The MMD Charge is described in Procedure XV of the Rules, which provides that, if the Market Maker (either the Member or the correspondent of the Member) holds a Net Unsettled Position that is greater than 40 percent of the overall unsettled long position (sum of each clearing broker's net long position) in that security in the CNS system, NSCC may impose the MMD Charge. NSCC calculates the MMD charge as the sum of each of the absolute values of the Net Unsettled Positions in these securities, less the reported amount of excess net capital for that Member.27 The MMD charge is designed to address dominated securities that are susceptible to marketability and liquidation impairment because of the relative size of the Net Unsettled Positions that NSCC would have to liquidate or hedge in the case of Member default.

    26See Procedure XV, Section I(A)(1)(d) of the Rules, supra note 4.

    27 NSCC does not apply the excess net capital offset for Members rated 7 on the Credit Risk Rating Matrix. See Procedure XV, Sections I(A)(1)(d) and I(A)(2)(c) of the Rules, supra note 4.

    Since the MMD Charge was implemented, the U.S. equities market has evolved with improved price transparency, access across exchange venues, and participation by market liquidity providers to reduce the risks that the charge was designed to address. Further, NSCC believes the MMD Charge may not effectively address concentration risk because (1) it only applies to Net Unsettled Positions in certain dominated securities, as described above and currently in Procedure XV of the Rules; (2) it does not address concentration risk presented by Net Unsettled Positions in securities that are not listed on NASDAQ or in securities traded by firms that are not Market Makers; and (3) it does not account for concentration in market capitalization categories.

    NSCC also believes that the proposed enhancements to the VaR Charge, specifically the introduction of an evenly-weighted volatility measure and the calculation of the Gap Risk Measure, would provide it with more effective measures of risks related to concentrated positions in its Members' portfolios. Subject to applicable thresholds, these proposed risk measures would be applicable to all Members as part of the calculation VaR Charge, and would not, like the MMD Charge, be limited to positions held by Market Makers. Further, as a threshold-based calculation, the Gap Risk Measure would provide NSCC with a more appropriate measure of the potential risk presented by a large Net Unsettled Position in a portfolio. Therefore, NSCC believes that these proposed enhancements to the VaR Charge and other existing risk management measures (described below) would provide it with more effective measures of the risks presented by concentrated positions, and, as such, it is appropriate to eliminate the MMD Charge.

    In order to implement this proposed change, NSCC would amend Procedure XV of the Rules by removing subsection (d) of Section I(A)(1) and subsection (c) of Section I(A)(2) of the Rules, and renumbering the subsequent subsections accordingly.

    (iv) Mitigating Risks of Concentrated Positions

    For the reasons described above, NSCC believes that the proposed enhancements to its VaR Charge would allow it to better measure and mitigate the risks presented by certain Net Unsettled Positions, including the risk presented to NSCC when those positions are concentrated in a particular security. One of the risks presented by a Net Unsettled Position concentrated in an asset class is that NSCC may not be able to liquidate or hedge the Net Unsettled Positions of a defaulted Member in the assumed timeframe at the market price in the event of a Member default. Because NSCC relies on external market data in connection with monitoring exposures to its Members, the market data may not reflect the market impact transaction costs associated with the potential liquidation as the concentration risk of a Net Unsettled Position increases. However, NSCC believes that, through the proposed changes and through existing risk management measures,28 it would be able to effectively measure and mitigate risks presented when a Member's Net Unsettled Positions are concentrated in a particular security.

    28 For example, pursuant to existing authority under Procedure XV, Sections I(A)(1)(e) and I(A)(2)(d) of the Rules (to be re-numbered pursuant this proposed rule change to Sections I(A)(1)(d) and I(A)(2)(c) of Procedure XV of the Rules), NSCC may require an additional payment as part of a Member's Required Deposit in the event it observes price fluctuations in or volatility or lack of liquidity of any security that are not otherwise addressed by its VaR Charge or the other components of the Clearing Fund. An example of where this additional payment may be required is in circumstances where NSCC identifies an exposure that is not adequately addressed by its margining methodology. Supra note 4.

    NSCC will continue to evaluate its exposures to these risks. Any future, proposed changes to the margining methodology to address such risks would be subject to a separate proposed rule change pursuant to Section 19(b)(1) of the Act,29 and the rules thereunder, and advance notice pursuant to Section 806(e)(1) of the Clearing Supervision Act,30 and the rules thereunder.

    29 15 U.S.C. 78s(b)(1).

    30 12 U.S.C. 5465(e)(1).

    2. Statutory Basis

    NSCC believes that the proposed changes described above are consistent with the requirements of the Act and the rules and regulations thereunder applicable to a registered clearing agency. In particular, NSCC believes that the proposed changes are consistent with Section 17A(b)(3)(F) of the Act,31 and Rules 17Ad-22(e)(4)(i) and (e)(6)(i) and (v), each promulgated under the Act,32 for the reasons described below.

    31 15 U.S.C. 78q-1(b)(3)(F).

    32 17 CFR 240.17Ad-22(e)(4)(i) and (e)(6)(i) and (v).

    Section 17A(b)(3)(F) of the Act 33 requires that the rules of NSCC be designed to, among other things, assure the safeguarding of securities and funds which are in the custody or control of the clearing agency or for which it is responsible. As discussed above, NSCC is proposing a number of changes to the way it calculates the VaR Charge, one of the components of its Members' Required Deposits—a key tool that NSCC uses to mitigate potential losses to NSCC associated with liquidating a Member's portfolio in the event of Member default. NSCC believes the proposed changes are designed to assure the safeguarding of securities and funds which are in its custody or control or for which it is responsible because they are designed to enable NSCC to better limit its exposure to Members in the event of a Member default.

    33 15 U.S.C. 78q-1(b)(3)(F).

    First, NSCC's proposal to introduce an additional calculation using its parametric VaR model that uses an evenly-weighted volatility estimation would better enable NSCC to limit its exposures to Members by enhancing the calculation of the VaR Charge to better cover the risk of a rapid change in market price volatility levels, including, for example, a drop in portfolio volatility in a stabilizing market. Second, the proposal to introduce the Gap Risk Measure calculation as an additional measure of volatility in connection with the calculation of the VaR Charge would better enable NSCC to limit its exposures to Members by more effectively capturing the risk that gap risk events impact the entire portfolio's value due to the idiosyncratic nature of the Net Unsettled Positions in that portfolio. Third, the proposal to introduce the Portfolio Margin Floor in its calculation of a Member's VaR Charge would enable NSCC to better limit its exposures to Members by better capturing the risks that may not be adequately accounted for in the other calculations of the VaR Charge. Finally, NSCC's proposal to eliminate the MMD Charge would enable NSCC to remove a component of the Required Deposit that provides NSCC with only a limited measure of risks presented by Net Unsettled Positions that are concentrated in certain securities, which NSCC believes it can more adequately measure through other proposed and existing risk management measures, as described above.

    By enabling NSCC to better limit its exposure to Members, the proposed changes are designed to ensure that, in the event of Member default, NSCC's operations would not be disrupted and non-defaulting Members would not be exposed to losses they cannot anticipate or control. In this way, the proposed rules are designed to assure the safeguarding of securities and funds which are in the custody or control of NSCC or for which it is responsible and therefore consistent with Section 17A(b)(3)(F) of the Act.34

    34Id.

    Rule 17Ad-22(e)(4)(i) under the Act 35 requires, in part, that NSCC establish, implement, maintain and enforce written policies and procedures reasonably designed to effectively identify, measure, monitor, and manage its credit exposures to participants and those arising from its payment, clearing, and settlement processes, including by maintaining sufficient financial resources to cover its credit exposure to each participant fully with a high degree of confidence.

    35 17 CFR 240.17Ad-22(e)(4)(i).

    As described above, the proposed changes would enable NSCC to better identify, measure, monitor, and, through the collection of Members' Required Deposits, manage its credit exposures to Members by maintaining sufficient resources to cover those credit exposures fully with a high degree of confidence. Each of the additional calculations that NSCC is proposing to introduce to enhance its methodology for calculating a Member's VaR Charge would provide NSCC with a more effective measure of the risks these calculations were designed to assess, as described above. As such, the proposed enhancements to the calculation of the VaR Charge would permit NSCC to more effectively identify, measure, monitor and manage its exposures to market price risk, and would enable it to better limit its exposure to potential losses from Member default. The proposal to use the highest result of each of the calculations as among the Core Parametric Estimation, the Gap Risk Measure and the Portfolio Margin Floor, would enable NSCC to manage its credit exposures by allowing it to collect and maintain sufficient resources to cover those exposures fully and with a high degree of confidence.

    Furthermore, removing the MMD Charge would enable NSCC to remove from the Clearing Fund calculations a component that is limited in scope and would allow it to address the risks presented by Net Unsettled Positions that are concentrated in certain securities more effectively by other Clearing Fund components and risk management measures.

    Therefore, the proposal would enhance NSCC's ability to effectively identify, measure and monitor its credit exposures and would enhance its ability to maintain sufficient financial resources to cover its credit exposure to each participant fully with a high degree of confidence. As such, NSCC believes the proposed changes are consistent with Rule 17Ad-22(e)(4)(i) under the Act.36

    36Id.

    Rule 17Ad-22(e)(6)(i) under the Act 37 requires, in part, that NSCC establish, implement, maintain and enforce written policies and procedures reasonably designed to cover its credit exposures to its participants by establishing a risk-based margin system that, at a minimum, considers, and produces margin levels commensurate with, the risks and particular attributes of each relevant product, portfolio, and market. Rule 17Ad-22(e)(6)(v) under the Act 38 requires, in part, that NSCC establish, implement, maintain and enforce written policies and procedures reasonably designed to cover its credit exposures to its participants by establishing a risk-based margin system that, at a minimum, uses an appropriate method for measuring credit exposure that accounts for relevant product risk factors and portfolio effects across products.

    37 17 CFR 240.17Ad-22(e)(6)(i).

    38 17 CFR 240.17Ad-22(e)(6)(v).

    The Required Deposits are made up of risk-based components (as margin) that, that are calculated and assessed daily to limit NSCC's credit exposures to Members. NSCC's proposal to enhance the calculation of its VaR Charge in order to more effectively address market price volatility would permit it to produce margin levels that are commensurate with the particular risk attributes, including risks related to rapid changes in market price volatility levels due to gap risk events, or risks related to a unique composition of securities within a portfolio, as described above. For example, the use of an evenly-weighted volatility estimation utilizing the VaR model, as an additional calculation of the VaR Charge, which gives equal weight to a long historical data set, rather than more weight to recent observations, would permit NSCC to more effectively measure the risk of a rapid change in market price volatility. The addition of the Gap Risk Measure and the Portfolio Margin Floor would also provide NSCC with additional measurements of the market price volatility of a Member's Net Unsettled Position, enabling NSCC to assess a VaR Charge that accounts for the risks those charges are designed to address, as described above.

    Finally, NSCC is proposing to eliminate the MMD Charge because this component of the Clearing Fund has only a limited application and, as such, does not provide as effective a measurement of the risk presented by Net Unsettled Positions that are concentrated in certain securities as other proposed and existing risk management measures. Therefore, the proposal to eliminate this charge would enable NSCC to remove an unnecessary component from the Clearing Fund calculation, and would help NSCC to rely on an appropriate method of measuring its exposures to this risk.

    The proposed changes are designed to assist NSCC in maintaining a risk-based margin system that considers, and produces margin levels commensurate with, the risks and particular attributes of portfolios that exhibit idiosyncratic risk attributes, are more susceptible to price volatility caused by to gap risk events, and contain concentrated Net Unsettled Positions. Therefore, NSCC believes the proposed change is consistent with Rule 17Ad-22(e)(6)(i) and (v) under the Act.39

    39 17 CFR 240.17Ad-22(e)(6)(i) and (v).

    (B) Clearing Agency's Statement on Burden on Competition

    NSCC believes that the proposed changes that would enhance the calculation of its VaR Charge could have an impact on competition. Specifically, NSCC believes that the proposed changes could burden competition because they would result in larger Required Deposit amounts for Members when the enhancements result in a VaR Charge that is greater than the amount calculated pursuant to the current methodology. When the proposal results in a larger VaR Charge, and, thus, a larger Required Deposit, for Members that have lower operating margins or higher costs of capital compared to other Members, the proposed changes could burden competition. However, the increase in Required Deposit would be in direct relation to the market price risk presented by each Members' Net Unsettled Positions, and each Member's Required Deposit would continue to be calculated with the same parameters and at the same confidence level for each Member. Therefore, Members that present similar Net Unsettled Positions would have similar impacts on their Required Deposit amounts. As such NSCC believe that any burden on competition imposed by the proposed changes would not be significant and, further, would be both necessary and appropriate in furtherance of NSCC's efforts to mitigate risks and meet the requirements of the Act, as described in this filing and further below.

    NSCC believes that the above described burden on competition that may be created by the proposed changes associated with the enhancements to the VaR Charge would be necessary in furtherance of the Act, specifically Section 17A(b)(3)(F) of the Act,40 because, as described above, the Rules must be designed to assure the safeguarding of securities and funds that are in NSCC's custody or control or which it is responsible. NSCC believes the proposed changes to enhance the VaR Charge would also support NSCC's compliance with Rules 17Ad-22(e)(4)(i) and Rule 17Ad-22(e)(6)(i) and (v) under the Act,41 which require NSCC to establish, implement, maintain and enforce written policies and procedures reasonably designed to (x) effectively identify, measure, monitor, and manage its credit exposures to participants and those arising from its payment, clearing, and settlement processes, including by maintaining sufficient financial resources to cover its credit exposure to each participant fully with a high degree of confidence; (y) cover its credit exposures to its participants by establishing a risk-based margin system that, at a minimum, considers, and produces margin levels commensurate with, the risks and particular attributes of each relevant product, portfolio, and market; and (z) cover its credit exposures to its participants by establishing a risk-based margin system that, at a minimum, uses an appropriate method for measuring credit exposure that accounts for relevant product risk factors and portfolio effects across products. As described above, NSCC believes implementing the proposed enhancements to the VaR Charge would improve the risk-based methodology that NSCC employs to measure market price risk and would better limit NSCC's credit exposures to Members, consistent with these requirements.

    40 15 U.S.C. 78q-1(b)(3)(F).

    41 17 CFR 240.17Ad-22(e)(4)(i) and (e)(6)(i) and (v).

    NSCC believes that the above described burden on competition that could be created by the proposed changes would be appropriate in furtherance of the Act because such changes have been appropriately designed to assure the safeguarding of securities and funds which are in the custody or control of NSCC or for which it is responsible, as described in detail above. By introducing additional calculations for arriving at a Member's final VaR Charge, each of which are designed to address the unique risks presented by Members' Net Unsettled Positions, as described above, the proposal would allow NSCC to produce margin levels commensurate with the risks and particular attributes of each Member's portfolio. Therefore, because the proposed changes were designed to provide NSCC with an appropriate measure of the risks presented by Members' Net Unsettled Positions, NSCC believes the proposals are appropriately designed to meet its risk management goals and its regulatory obligations.

    NSCC believes that it has designed the proposed changes in a reasonable and appropriate way in order to meet compliance with its obligations under the Act. Specifically, implementing the proposed enhancements to the calculation of its VaR Charge would improve the risk-based margining methodology that NSCC employs to set margin requirements and better limit NSCC's credit exposures to its Members. Therefore, NSCC believes the proposed changes are necessary and appropriate in furtherance of NSCC's obligations under the Act, specifically Section 17A(b)(3)(F) of the Act 42 and Rules 17Ad-22(e)(4)(i) and Rule 17Ad-22(e)(6)(i) and (v) under the Act.43

    42 15 U.S.C. 78q-1(b)(3)(F).

    43 17 CFR 240.17Ad-22(e)(4)(i) and (e)(6)(i) and (v).

    Because the proposal to eliminate the MMD Charge would remove this charge from the margining methodology as applied to all Members, when applicable, NSCC does not believe the proposed change to eliminate the MMD Charge would have any impact on competition.

    (C) Clearing Agency's Statement on Comments on the Proposed Rule Change Received From Members, Participants, or Others

    While NSCC has not solicited or received any written comments relating to this proposal, NSCC has conducted outreach to Members in order to provide them with notice of the proposal. NSCC will notify the Commission of any written comments received by NSCC.

    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 clearing agency consents, the Commission will:

    (A) By order approve or disapprove such proposed rule change, or

    (B) institute proceedings to determine whether the proposed rule change should be disapproved.

    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 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-NSCC-2017-020 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-NSCC-2017-020. 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 website (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 website 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 NSCC and on DTCC's website (http://dtcc.com/legal/sec-rule-filings.aspx). 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-NSCC-2017-020 and should be submitted on or before February 9, 2018.

    For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.44

    Eduardo A. Aleman, Assistant Secretary.

    44 17 CFR 200.30-3(a)(12).

    [FR Doc. 2018-00851 Filed 1-18-18; 8:45 am] BILLING CODE 8011-01-P
    SECURITIES AND EXCHANGE COMMISSION [Release No. 34-82499; File No. SR-Phlx-2018-02] Self-Regulatory Organizations; Nasdaq PHLX LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Adopt Pricing for NDXP January 12, 2018.

    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 January 3, 2018, Nasdaq PHLX LLC (“Phlx” or “Exchange”) filed with the Securities and Exchange Commission (“SEC” or “Commission”) the proposed rule change as described in Items I, II, and III, below, which Items have been prepared by the Exchange. The Commission is publishing this notice to solicit comments on the proposed rule change from interested persons.

    1 15 U.S.C. 78s(b)(1).

    2 17 CFR 240.19b-4.

    I. Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change

    The Exchange proposes to amend the Exchange's Pricing Schedule to add pricing for P.M.-settled options on broad-based indexes with nonstandard expiration dates for a period of twelve months, which the Commission recently approved.3

    3See Securities and Exchange Act Release No. 82341 (December 15, 2017), 82 FR 60651 (December 21, 2017) (SR-Phlx-2017-79).

    While changes to the Pricing Schedule pursuant to this proposal are effective upon filing, the Exchange has designated these changes to be operative on January 4, 2018.

    The text of the proposed rule change is available on the Exchange's website at http://nasdaqphlx.cchwallstreet.com/, at the principal office of the Exchange, and at the Commission's Public Reference Room.

    II. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.

    A. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change 1. Purpose

    The Exchange recently received approval to list P.M.-settled options on broad-based indexes with nonstandard expiration dates on a twelve month pilot basis, beginning on December 15, 2017.4 This pilot permits both Weekly Expirations and End of Month expirations similar to those of the A.M.-settled broad-based index options, except that the exercise settlement value will be based on the index value derived from the closing prices of component stocks.5 The Exchange proposes to list these aforementioned options, commencing on January 4, 2017, with the symbol “NDXP.”

    4Id.

    5Id.

    Specifically, the Exchange proposes to adopt the current index pricing applicable to NDX 6 today to NDXP.

    6 NDX represents options on the Nasdaq 100® Index and is traded under the symbol NDX (“NDX”).

    Customer Rebate

    Today, Customer Rebates in Section B of the Pricing Schedule are not paid on NDX in any Category. However, NDX will count toward the volume requirement to qualify for a Customer 7 Rebate Tier. The Exchange proposes to apply the same pricing for NDXP as it relates to Customer Rebates. The Exchange believes that this will continue to encourage market participants to add Customer liquidity on Phlx.

    7 The term “Customer” or (“C”) applies to any transaction that is identified by a Participant for clearing in the Customer range at The Options Clearing Corporation (“OCC”) and which is not for the account of broker or dealer or for the account of a “Professional” (as that term is defined in Chapter I, Section 1(a)(48)).

    Transaction Charges in Section II

    Today, electronic and floor Options Transaction Charges for NDX are $0.75 per contract for all Non-Customers. No transaction charge for NDX applies to Customers. A $0.25 per contract 8 surcharge is assessed to Non-Customers in NDX. The Exchange proposes these options transaction charges for NDXP. Today, a $0.10 per contract surcharge will be assessed to electronic Complex Orders that remove liquidity from the Complex Order Book and auctions, excluding PIXL, in Non-Penny Pilot Options (excluding NDX). This exclusion would apply likewise to NDXP.

    8 The Exchange proposes to add the words “per contract” to note 5 in Section II of the Pricing Schedule to make clear that the surcharge is assessed on a per contract basis.

    Today, Specialists and Market Makers are subject to a “Monthly Market Maker Cap” of $500,000 for: (i) Electronic Option Transaction Charges, excluding surcharges and excluding options overlying NDX; and (ii) QCC Transaction Fees (as defined in Exchange Rule 1080(o) and Floor QCC Orders, as defined in 1064(e)). NDXP would likewise be excluded.

    Firms are subject to a maximum fee of $75,000 (“Monthly Firm Fee Cap”). Firm Floor Option Transaction Charges and QCC Transaction Fees, in the aggregate, for one billing month will not exceed the Monthly Firm Fee Cap per member organization when such members are trading in their own proprietary accounts. All dividend, merger, and short stock interest strategy executions (as defined in this Section II) are excluded from the Monthly Firm Fee Cap. NDX Options Transactions are excluded from the Monthly Firm Fee Cap. NDXP will likewise be excluded.

    The Firm Floor Options Transaction Charges will be waived for members executing facilitation orders pursuant to Exchange Rule 1064 when such members are trading in their own proprietary accounts (including Cabinet Options Transaction Charges). The Firm Floor Options Transaction Charges will be waived for the buy side of a transaction if the same member or its affiliates under Common Ownership represent both sides of a Firm transaction when such members are trading in their own proprietary accounts. In addition, the Broker-Dealer Floor Options Transaction Charge (including Cabinet Options Transaction Charges) will be waived for members executing facilitation orders pursuant to Exchange Rule 1064 when such members would otherwise incur this charge for trading in their own proprietary accounts contra to a Customer (“BD-Customer Facilitation”), if the member's BD-Customer Facilitation average daily volume (including both FLEX and non-FLEX transactions) exceeds 10,000 contracts per day in a given month. NDX Options Transactions are excluded from each of the waivers set forth in the above paragraph. NDXP will likewise be excluded from the waivers.

    Marketing Fees

    No Marketing Fees are assessed on transactions in NDX. NDXP will likewise be excluded.

    PIXL Pricing

    Options overlying NDX are not subject to Section IV.A.—PIXL Pricing. NDX transactions in PIXL will be subject to Section II pricing. NDXP will not be subject to PIXL Pricing, similar to NDX, NDXP will be subject to the Section II pricing noted herein.

    FLEX Transaction Fees

    The Monthly Firm Fee Cap, Monthly Market Maker Cap, Strategy Caps and the Options Surcharge described in Section II of the Pricing Schedule apply to FLEX Transaction Fees for NDX and will likewise apply to NDXP in the same manner.

    Market Access and Routing Subsidy (“MARS”)

    MARS Payment [sic] are made to Phlx members that have System Eligibility and have routed the requisite number of Eligible Contracts daily in a month, which were executed on Phlx. Options overlying NDX are not considered Eligible Contracts. NDXP will not be considered Eligible Contracts.

    The Exchange believes that the above-referenced pricing for NDX continues to be competitive and attract volume to Phlx. The Exchange believes that the proposed pricing is suitable because NDXP represent similar options on the same underlying, the Nasdaq 100® Index.

    2. Statutory Basis

    The Exchange believes that its proposal is consistent with Section 6(b) of the Act,9 in general, and furthers the objectives of Sections 6(b)(4) and 6(b)(5) of the Act,10 in particular, in that it provides for the equitable allocation of reasonable dues, fees and other charges among members and issuers and other persons using any facility, and is not designed to permit unfair discrimination between customers, issuers, brokers, or dealers.

    9 15 U.S.C. 78f(b).

    10 15 U.S.C. 78f(b)(4) and (5).

    The Commission and the courts have repeatedly expressed their preference for competition over regulatory intervention in determining prices, products, and services in the securities markets. In Regulation NMS, while adopting a series of steps to improve the current market model, the Commission highlighted the importance of market forces in determining prices and SRO revenues and, also, recognized that current regulation of the market system “has been remarkably successful in promoting market competition in its broader forms that are most important to investors and listed companies.” 11

    11 Securities Exchange Act Release No. 51808 (June 9, 2005), 70 FR 37496, 37499 (June 29, 2005) (“Regulation NMS Adopting Release”).

    Likewise, in NetCoalition v. Securities and Exchange Commission12 (“NetCoalition”) the DC Circuit upheld the Commission's use of a market-based approach in evaluating the fairness of market data fees against a challenge claiming that Congress mandated a cost-based approach.13 As the court emphasized, the Commission “intended in Regulation NMS that `market forces, rather than regulatory requirements' play a role in determining the market data . . . to be made available to investors and at what cost.” 14

    12NetCoalition v. SEC, 615 F.3d 525 (D.C. Cir. 2010).

    13See NetCoalition, at 534—535.

    14Id. at 537.

    Further, “[n]o one disputes that competition for order flow is `fierce'. . . . As the SEC explained, `[i]n the U.S. national market system, buyers and sellers of securities, and the broker-dealers that act as their order-routing agents, have a wide range of choices of where to route orders for execution'; [and] `no exchange can afford to take its market share percentages for granted' because `no exchange possesses a monopoly, regulatory or otherwise, in the execution of order flow from broker dealers'. . . .” 15 Although the court and the SEC were discussing the cash equities markets, the Exchange believes that these views apply with equal force to the options markets.

    15Id. at 539 (quoting Securities Exchange Act Release No. 59039 (December 2, 2008), 73 FR 74770, 74782-83 (December 9, 2008) (SR-NYSEArca-2006-21)).

    Customer Rebate

    The Exchange's proposal to not pay the Customer Rebates in Section I of the Pricing Schedule on NDXP and count NDXP volume toward qualifying for a Customer Rebate Tier, similar to NDX, is reasonable because the Exchange desires to calculate and pay rebates on NDXP in a similar manner to NDX. NDX and NDXP represent similar options on the same underlying, the Nasdaq 100® Index. Further, it is reasonable to not pay Customer Rebates on NDXP in any Category (A, B or C) because this index will be exclusively listed on Nasdaq exchanges only.16 The original intent of the Customer Rebate Program was to pay rebates on electronically-delivered Multiply-Listed Options. By definition, NDXP will not be a Multiply-Listed Option. The Exchange does not desire to pay rebates on NDXP because of its exclusivity. The Exchange believes it is reasonable to continue to count NDXP in the total volume to qualify a market participant for a Customer Rebate. However, market participants in NDXP will not be paid the Customer rebates in any Category because of the exclusivity of this option. Market participants would continue to benefit from NDXP options volume in terms of qualifying for Customer Rebate Tiers.

    16 Nasdaq intends to list NDXP on other Nasdaq-owned self-regulatory organizations in addition to Phlx at a later date.

    The Exchange's proposal to not pay the Customer Rebates in Section I of the Pricing Schedule on NDXP and count NDXP volume toward qualifying for a Customer Rebate Tier, similar to NDX, is equitable and not unfairly discriminatory because the Exchange would apply its calculation to determine the eligibility and payment of Customer rebates in a uniform manner. Further, the Exchange would not pay Customer Rebates on any NDXP transaction to any market participant. Also, any market participant is eligible to earn a Customer Rebate.

    Transaction Charges in Section II

    The Exchange's proposal to assess the same electronic and floor Options Transaction Charges for NDXP as it assesses for NDX 17 is reasonable because the Exchange's transaction charges for its proprietary products are competitive when compared with similar proprietary products.18 The Exchange's proposal to assess the same electronic and floor Options Transaction Charges for NDXP and NDX is equitable and not unfairly discriminatory because the Exchange would assess the same options transaction charges to all Non-Customer market participants. The Exchange believes that assessing Customers no transaction fee for NDXP is equitable and not unfairly discriminatory because Customer orders bring valuable liquidity to the market, which liquidity benefits other market participants. Customer liquidity benefits all market participants by providing more trading opportunities, which attracts Specialists and Market Makers. An increase in the activity of these market participants in turn facilitates tighter spreads, which may cause an additional corresponding increase in order flow from other market participants.

    17 Today, electronic and floor Options Transaction Charges for options overlying NDX are $0.75 per contract for all Non-Customers. No transaction charge for NDX applies to Customers. A $0.25 per contract surcharge is assessed to Non-Customers in NDX. Also, a $0.10 per contract surcharge is assessed to electronic Complex Orders that remove liquidity from the Complex Order Book and auctions, excluding PIXL, in Non-Penny Pilot Options (excluding NDX).

    18See Chicago Board Options Exchange, Incorporated's (“CBOE”) Fees Schedule. Russell 2000 Index (“RUT”) options transactions on CBOE, except customers, are assessed a $0.45 per contract surcharge. CBOE assesses Professionals and Broker-Dealers a manual and AIM transaction fee of $0.25 per contract and a non-AIM transaction fee of $0.65 per contract. CBOE assesses Clearing Trade Permit Holders a transaction fee of $0.22 per contract, subject to a sliding scale.

    The Exchange notes that the proposed transaction charges are reasonable, equitable and not unfairly discriminatory as NDXP will be an exclusively listed product. Similar to NDX, the Exchange seeks to recoup the operational costs 19 for listing proprietary products. Also, pricing by symbol is a common practice on many U.S. options exchanges as a means to incentivize order flow to be sent to an exchange for execution in particular products. Other options exchanges price by symbol.20 Further, the Exchange notes that with its products, market participants are offered an opportunity to either transact NDXP or separately execute options overlying PowerShares QQQ Trust (“QQQ”).21 Offering products such as QQQ provides market participants with a variety of choices in selecting the product they desire to utilize to transact the Nasdaq 100® Index.22 When exchanges are able to recoup costs associated with offering proprietary products, it incentivizes growth and competition for the innovation of additional products.

    19 By way of example, in analyzing an obvious error, the Exchange would have additional data points available in establishing a theoretical price for a Multiply Listed Option as compared to a proprietary product, which requires additional analysis and administrative time to comply with Exchange rules to resolve an obvious error.

    20See pricing for RUT on CBOE's Fees Schedule.

    21 QQQ is an exchange-traded fund based on the Nasdaq-100 Index®.

    22 QQQ options overlies[sic] the same Index as NDX, namely the Nasdaq 100® Index. This relationship between QQQ options and NDX options is similar to the relationship between RUT, the iShares Russell 2000 Index, and IWM which is the ETF on RUT.

    The Exchange's proposal to add the words “per contract” to note 5 in Section II of the Pricing Schedule to make clear the surcharge is per contract is reasonable, equitable and not unfairly discriminatory because it will conform the language to the remainder of the transaction charges in Section II of the Pricing Schedule.

    The Exchange's proposal to exclude NDXP from the Monthly Market Maker Cap and the Monthly Firm Fee Cap is reasonable because NDX, another proprietary product is likewise excluded today. Market Makers will continue to be able to utilize the cap to reduce electronic Option Transaction Charges, excluding surcharges, QCC transaction fees and Floor QCC Orders, NDX and now NDXP despite the exclusions.

    The Exchange's proposal to exclude NDXP from the Monthly Market Maker Cap and the Monthly Firm Fee Cap is equitable and not unfairly discriminatory because no market participant would be eligible to count NDXP toward either the Monthly Market Maker Cap or the Monthly Firm Fee Cap.

    The Exchange's proposal to exclude NDXP from the Firm Floor Options Transaction waivers for members executing facilitation orders pursuant to Exchange Rule 1064,23 from the buy side of a transaction, if the same member or its affiliates under Common Ownership represent both sides of a Firm transaction when such members are trading in their own proprietary account, and from the waiver for the Broker-Dealer Floor Options Transaction Charge for members executing facilitation orders pursuant to Exchange Rule 1064,24 is reasonable because NDX, another proprietary product is likewise excluded today.

    23 This waiver applies when such members would otherwise incur this charge for trading in their own proprietary account contra to a Customer (“BD-Customer Facilitation”), if the member's BD-Customer Facilitation average daily volume (including both FLEX and non-FLEX transactions) exceeds 10,000 contracts per day in a given month.

    24Id.

    The Exchange's proposal to exclude NDXP from the Firm Floor Options Transaction waivers for members executing facilitation orders pursuant to Exchange Rule 1064,25 from the buy side of a transaction, if the same member or its affiliates under Common Ownership represents both sides of a Firm transaction when such members are trading in their own proprietary account, and from the waiver for the Broker-Dealer Floor Options Transaction Charge for members executing facilitation orders pursuant to Exchange Rule 1064,26 is equitable and not unfairly discriminatory because no market participant would be eligible to count NDXP toward these waivers.

    25Id.

    26Id.

    Marketing Fee

    The Exchange's proposal to exclude NDXP from the Marketing Fee is reasonable because NDXP is an exclusively listed product, similar to NDX, which is also excluded from the Marketing Fee. The Exchange notes that Specialists and Market Makers transaction fees will remain in line with other market participants for NDXP.

    The Exchange's proposal to exclude NDXP from the Marketing Fee is equitable and not unfairly discriminatory because the Exchange will assess uniform transaction fees for all Non-Customers because the transaction charges, as proposed above, would otherwise be uniform for all market participants. The Exchange believes that assessing Customers no transaction fee for NDXP is equitable and not unfairly discriminatory because Customer orders bring valuable liquidity to the market, which liquidity benefits other market participants. Customer liquidity benefits all market participants by providing more trading opportunities, which attracts Specialists and Market Makers. An increase in the activity of these market participants in turn facilitates tighter spreads, which may cause an additional corresponding increase in order flow from other market participants.

    PIXL Pricing

    The Exchange's proposal to exclude NDXP from Section IV.A.—PIXL Pricing and instead assess NDXP transactions in PIXL the Section II pricing, similar to NDX, is reasonable because the Exchange believes that the PIXL pricing continues to be competitive despite the exclusion of NDXP. The Exchange's proposal to exclude NDXP from the PIXL Pricing in Section IV, Part A and instead assess NDXP transactions in PIXL the Section II pricing is equitable and not unfairly discriminatory because the Exchange will uniformly exclude NDXP from PIXL pricing.

    FLEX Transaction Fees

    The Exchange's proposal to assess NDXP the same FLEX Transaction Fees as are assessed for NDX today is reasonable because the Exchange desires to assess the same fees for index products. The Exchange's proposal to assess NDXP the same FLEX Transaction Fees as are assessed for NDX today is equitable and not unfairly discriminatory because the Exchange will uniformly assess FLEX fees for NDXP in a uniform manner for all market participants.

    Market Access and Routing Subsidy (“MARS”)

    The Exchange's proposal to exclude NDXP from Eligible Contracts for purposes of qualifying for a MARS Payment is reasonable because the Exchange believes that despite the exclusion of NDXP, MARS remains a competitive offering. The Exchange's proposal to exclude NDXP from Eligible Contracts for purposes of qualifying for a MARS Payment is equitable and not unfairly discriminatory because the Exchange will uniformly exclude NDXP from MARS.

    B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act. In terms of inter-market competition, the Exchange notes that it operates in a highly competitive market in which market participants can readily favor competing venues if they deem fee levels at a particular venue to be excessive, or rebate opportunities available at other venues to be more favorable. The Exchange notes that with its products, market participants are offered an opportunity to either transact NDXP or separately execute options overlying PowerShares QQQ Trust (“QQQ”). Offering products such as QQQ provides market participants with a variety of choices in selecting the product they desire to utilize to transact the Nasdaq 100 Index.27

    27See note 22 above.

    Customer Rebate

    The Exchange's proposal to not pay the Customer Rebates in Section I of the Pricing Schedule on NDXP and count NDXP volume toward qualifying for a Customer Rebate Tier, similar to NDX, does not impose an undue burden on competition because the Exchange would apply its calculation to determine the eligibility and payment of Customer rebates in a uniform manner. The Exchange's proposal to not pay Customer Rebates on NDXP in any Category is equitable and not unfairly discriminatory because the Exchange would not pay Customer Rebates on any transaction with NDXP to any market participant. Also, any market participant is eligible to earn a Customer Rebate.

    Transaction Charges in Section II

    The Exchange's proposal to assess for the same electronic and floor Options Transaction Charges for NDXP and NDX does not impose an undue burden on competition because the Exchange would assess the same options transaction charges to all Non-Customer market participants. The Exchange believes that assessing Customers no transaction fee for NDXP does not impose an undue burden on competition because Customer orders bring valuable liquidity to the market, which liquidity benefits other market participants. Customer liquidity benefits all market participants by providing more trading opportunities, which attracts Specialists and Market Makers. An increase in the activity of these market participants in turn facilitates tighter spreads, which may cause an additional corresponding increase in order flow from other market participants.

    The Exchange's proposal to add the words “per contract” to note 5 in Section II of the Pricing Schedule to make clear the surcharge is per contract does not impose an undue burden on competition because it will conform the language to the remainder of the transaction charges in Section II of the Pricing Schedule.

    The Exchange's proposal to exclude NDXP from the Monthly Market Maker Cap and the Monthly Firm Fee Cap does not impose an undue burden on competition because no market participant would be eligible to count NDXP toward either the Monthly Market Maker Cap or the Monthly Firm Fee Cap.

    The Exchange's proposal to exclude NDXP from the Firm Floor Options Transaction waivers for members executing facilitation orders pursuant to Exchange Rule 1064, from the buy side of a transaction, if the same member or its affiliates under Common Ownership represents both sides of a Firm transaction when such members are trading in their own proprietary account, and from the waiver for the Broker-Dealer Floor Options Transaction Charge for members executing facilitation orders pursuant to Exchange Rule 1064, does not impose an undue burden on competition because no market participant would be eligible to count NDXP toward these waivers.

    Marketing Fee

    The Exchange's proposal to exclude NDXP from the Marketing Fee does not impose an undue burden on competition because the Exchange will assess uniform transaction fees for all Non-Customers because the transaction charges, as proposed above, would otherwise be uniform for all market participants. The Exchange believes that assessing Customers no transaction fee for NDXP does not impose an undue burden on competition because Customer orders bring valuable liquidity to the market, which liquidity benefits other market participants. Customer liquidity benefits all market participants by providing more trading opportunities, which attracts Specialists and Market Makers. An increase in the activity of these market participants in turn facilitates tighter spreads, which may cause an additional corresponding increase in order flow from other market participants.

    PIXL Pricing

    The Exchange's proposal to exclude NDXP from the PIXL Pricing in Section IV, Part A and instead assess NDXP transactions in PIXL the Section II pricing does not impose an undue burden on competition because the Exchange will uniformly exclude NDXP from PIXL pricing.

    FLEX Transaction Fees

    The Exchange's proposal to assess NDXP the same FLEX Transaction Fees as are assessed for NDX today does not impose an undue burden on competition because the Exchange will uniformly assess FLEX fees for NDXP in a uniform manner for all market participants.

    MARS Subsidy

    The Exchange's proposal to exclude NDXP from Eligible Contracts for purposes of qualifying for a MARS Payment does not impose an undue burden on competition because the Exchange will uniformly exclude NDXP from MARS.

    C. Self-Regulatory Organization's Statement on Comments on the Proposed Rule Change Received From Members, Participants, or Others

    No written comments were either solicited or received.

    III. Date of Effectiveness of the Proposed Rule Change and Timing for Commission Action

    The foregoing rule change has become effective pursuant to Section 19(b)(3)(A)(ii) of the Act.28

    28 15 U.S.C. 78s(b)(3)(A)(ii).

    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: (i) Necessary or appropriate in the public interest; (ii) for the protection of investors; or (iii) otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.

    IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:

    Electronic Comments

    • Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or

    • Send an email to [email protected]. Please include File Number SR-Phlx-2018-02 on the subject line.

    Paper Comments

    • Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.

    All submissions should refer to File Number SR-Phlx-2018-02. 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 website (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 website viewing and printing in the Commission's Public Reference Room, 100 F Street NE, Washington, DC 20549, on official business days between the hours of 10:00 a.m. and 3:00 p.m. Copies of the filing also will be available for inspection and copying at the principal office of the Exchange. All comments received will be posted without change; the Commission does not edit personal identifying information from submissions. You should submit only information that you wish to make available publicly. All submissions should refer to File Number SR-Phlx-2018-02 and should be submitted on or before February 9, 2018.

    29 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.29

    Eduardo A. Aleman, Assistant Secretary.
    [FR Doc. 2018-00856 Filed 1-18-18; 8:45 am] BILLING CODE 8011-01-P
    SECURITIES AND EXCHANGE COMMISSION [Release No. 34-82495; File No. SR-Phlx-2018-08] Self-Regulatory Organizations; Nasdaq PHLX LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend the Exchange's Fee Schedule at Chapter IX January 12, 2018.

    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 January 9, 2018, Nasdaq PHLX LLC (“PHLX” or “Exchange”) filed with the Securities and Exchange Commission (“SEC” or “Commission”) the proposed rule change as described in Items I, II, and III below, which Items have been prepared by the Exchange. The Commission is publishing this notice to solicit comments on the proposed rule change from interested persons.

    1 15 U.S.C. 78s(b)(1).

    2 17 CFR 240.19b-4.

    I. Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change

    The Exchange proposes to amend the Exchange's fee schedule at Chapter IX (Proprietary Data Feed Fees) to change the Internal Distributor fee for Top of PHLX Options Plus Orders to reflect substantial enhancements to the product since the current Distributor fees were set in 2010, as described further below.

    The text of the proposed rule change is available on the Exchange's website at http://nasdaqphlx.cchwallstreet.com/, at the principal office of the Exchange, and at the Commission's Public Reference Room.

    II. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.

    A. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change 1. Purpose

    The purpose of the proposed rule change is to amend the Exchange's fee schedule at Chapter IX (Proprietary Data Feed Fees) to change the Internal Distributor fee for TOPO Plus Orders (“TOPO Plus”) to reflect substantial enhancements to the product since the current Distributor fees were set in 2010.

    TOPO Plus is a direct, low-latency market data product that allows subscribers to connect to both the Top of PHLX Options (“TOPO”) data feed and the PHLX Orders data feed. TOPO provides subscribers a direct data feed that includes the Exchange's best bid and offer position, with aggregate size, based on displayable order and quoting interest on the Exchange. TOPO also provides last sale information from PHLX.

    PHLX Orders includes the full limit order book and contains a real-time status of simple and complex orders on the PHLX order book for all PHLX-listed options. This includes new orders and changes to orders resting on the PHLX book. The PHLX Orders feed includes opening imbalance data, Price Improvement XL (PIXL) data and Complex Order Live Auction (COLA) information, in addition to the full limit order book data for both simple and complex orders.

    The fee for TOPO Plus varies, depending on whether the subscriber is an Internal Distributor, an External Distributor, a Non-Professional Subscriber, or a Professional Subscriber.3

    3 Chapter IX of the Pricing Schedule defines a distributor as “any entity that receives a feed or data file of data directly from Nasdaq PHLX or indirectly through another entity and then distributes it either internally (within that entity) or externally (outside that entity).”

    Chapter IX of the Pricing Schedule defines a Non-Professional Subscriber as “a natural person who is neither: (i) Registered or qualified in any capacity with the Commission, the Commodities Futures Trading Commission, any state securities agency, any securities exchange or association, or any commodities or futures contract market or association; (ii) engaged as an `investment adviser' as that term is defined in Section 201(11) of the Investment Advisors Act of 1940 (whether or not registered or qualified under that Act); nor (iii) employed by a bank or other organization exempt from registration under federal or state securities laws to perform functions that would require registration or qualification if such functions were performed for an organization not so exempt. A Non-Professional Subscriber may only use the data provided for personal purposes and not for any commercial purpose.”

    Chapter IX of the Pricing Schedule defines a Professional Subscriber as “any Subscriber that is not a Non-Professional Subscriber. If the Nasdaq Subscriber agreement is signed in the name of a business or commercial entity, such entity would be considered a Professional Subscriber.”

    Currently, the monthly fee for an Internal Distributor is $4,000, the monthly fee for an External Distributor is $5,000, the monthly fee for a Non-Professional Subscriber is $1, and the monthly fee for a Professional Subscriber is $40. The Exchange is now proposing to increase the monthly fee for an Internal Distributor to $4,500. Since its inception in 2010, the Exchange has not raised the Internal or External Distributor fee and yet has made substantial improvements to the product as illustrated below.4

    4See Securities Exchange Act Release No. 62194 (May 28, 2010) 75 FR 31830 (SR-Phlx-2010-48) (approving TOPO Plus fees) (“TOPO Plus approval order”).

    While the Exchange has not raised the fees for TOPO Plus since its inception, the Exchange has added a number of functional enhancements to both TOPO and PHLX Orders in particular, and to Exchange systems in general, that enhance the value of the TOPO Plus data product. Specifically:

    • In July 2011, the Exchange began disseminating timestamp messages for TOPO and TOPO Plus Orders in nanoseconds instead of milliseconds to provide additional granularity to the order book data contained in those products.5

    5See http://www.nasdaqtrader.com/TraderNews.aspx?id=dtn2011-016.

    • In December 2012, the Exchange enhanced TOPO Plus to include an updated Auction Notification Message with an Order Exposure Auction Type, which notifies participants when there is an aggressively priced order available for execution that may be routed away.6 This change helps customers understand the types of auction messages coming into the system.7

    6See Securities Exchange Act Release No. 68517 (December 21, 2012), 77 FR 77134 (December 31, 2012) (SR-Phlx-2012-136).

    7See http://www.nasdaqtrader.com/TraderNews.aspx?id=dtn2012-31.

    The Order Exposure auction message is sent when there is an exposed buy (or sell) order available for execution at the National Best Offer (or National Best Bid). The exposed order volume may be routed away.

    • In September 2013, the Exchange updated the Complex Auction Notification Message in PHLX Orders to unmask the Price, Side and Debit or Credit fields, which had been previously marked with an asterisk, leading to more transparency on the complex auction message.8

    8See http://www.nasdaqtrader.com/TraderNews.aspx?id=dtn2013-40.

    • In November 2014, the Exchange added Implied Orders to the Simple Order Message of PHLX Orders.9 These orders serve to attract interest to trade with the resting Complex Order for which they represent.10

    9See Securities Exchange Act Release No. 73545 (November 6, 2014), 79 FR 67498 (November 13, 2014) (SR-Phlx-2014-54) (approval order).

    10See http://www.nasdaqtrader.com/TraderNews.aspx?id=dtn2014-35.

    Implied Orders are limit orders generated by the Exchange on behalf of Complex Orders which represent one leg of a two-legged Complex Order. Implied Orders are automatically generated on behalf of Complex Orders resting on the top of the Complex Order Book so that they are represented at the best bid and/or offer on the Exchange for the individual legs.

    • In September 2015, the Exchange automated the expiration process relating to World Currency Options (“WCO”), and updated the TOPO and PHLX Orders market data specifications to accommodate a new value of “W” to represent the 12:00 p.m. ET closure of expiring WCO options in the Options Directory message and System Event messages.11

    11See http://www.nasdaqtrader.com/TraderNews.aspx?id=dtn2015-19.

    • In February 2016, the Exchange expanded the period pursuant to which the TOPO Plus product, among other products, will be made available at the beginning of the trading day. The Exchange moved up the dissemination times of the Start of Message process by two hours, to 4:00 a.m., ET., to provide members with additional time for connectivity testing and to better align with the opening times of the equity markets.12 On December 18, 2017, the Exchange further expanded the period for which TOPO Plus will be made available at the beginning of the trading day, to 2 a.m.13

    12See http://www.nasdaqtrader.com/TraderNews.aspx?id=dtn2015-29.

    13See http://www.nasdaqtrader.com/TraderNews.aspx?id=dtn2017-34.

    • In August 2015, the Exchange launched its new Disaster Recovery (“DR”) facility in Chicago, Illinois. In addition to offering expanded geographic diversity, this new location enables firms to easily connect to numerous multi-asset engines, both to receive market data and to send orders, currently housed in or near this facility, potentially reducing overall networking costs. With this DR facility upgrade, new equipment was installed that improved performance and resilience as well.14

    14See http://www.nasdaqtrader.com/TraderNews.aspx?id=dtn2015-17.

    • In January 2017, the Exchange introduced additional multicast IP addresses for proprietary equity and options feeds, known as “B” feeds, for the feeds from its DR facility in Chicago. The purpose of this change was to promote resiliency and provide additional recovery options to market participants within the same facility.15

    15See http://www.nasdaqtrader.com/TraderNews.aspx?id=dtn2017-02.

    Given these specific enhancements to TOPO and PHLX Orders, and to the Exchange's system generally, and given the fact that the Exchange has not increased the Distributor fees for TOPO Plus since its inception, the Exchange believes that the proposed fee increase is appropriate.

    2. Statutory Basis

    The Exchange believes that its proposal is consistent with Section 6(b) of the Act,16 in general, and furthers the objectives of Sections 6(b)(4) and 6(b)(5) of the Act,17 in particular, in that it provides for the equitable allocation of reasonable dues, fees and other charges among members and issuers and other persons using any facility, and is not designed to permit unfair discrimination between customers, issuers, brokers, or dealers.

    16 15 U.S.C. 78f(b).

    17 15 U.S.C. 78f(b)(4) and (5).

    The Commission and the courts have repeatedly expressed their preference for competition over regulatory intervention in determining prices, products, and services in the securities markets. In Regulation NMS, while adopting a series of steps to improve the current market model, the Commission highlighted the importance of market forces in determining prices and self-regulatory organization (“SRO”) revenues and, also, recognized that current regulation of the market system “has been remarkably successful in promoting market competition in its broader forms that are most important to investors and listed companies.” 18

    18 Securities Exchange Act Release No. 51808 (June 9, 2005), 70 FR 37496, 37499 (June 29, 2005) (“Regulation NMS Adopting Release”).

    Likewise, in NetCoalition v. Securities and Exchange Commission19 (“NetCoalition”) the DC Circuit upheld the Commission's use of a market-based approach in evaluating the fairness of market data fees against a challenge claiming that Congress mandated a cost-based approach.20 As the court emphasized, the Commission “intended in Regulation NMS that `market forces, rather than regulatory requirements' play a role in determining the market data . . . to be made available to investors and at what cost.” 21

    19NetCoalition v. SEC, 615 F.3d 525 (DC Cir. 2010).

    20See NetCoalition, at 534-535.

    21Id. at 537.

    Further, “[n]o one disputes that competition for order flow is `fierce.' . . . As the SEC explained, `[i]n the U.S. national market system, buyers and sellers of securities, and the broker-dealers that act as their order-routing agents, have a wide range of choices of where to route orders for execution'; [and] `no exchange can afford to take its market share percentages for granted' because `no exchange possesses a monopoly, regulatory or otherwise, in the execution of order flow from broker dealers'. . . .” 22 Although the court and the SEC were discussing the cash equities markets, the Exchange believes that these views apply with equal force to the options markets.

    22Id. at 539 (quoting Securities Exchange Act Release No. 59039 (December 2, 2008), 73 FR 74770, 74782-83 (December 9, 2008) (SR-NYSEArca-2006-21)).

    The Exchange believes that the proposed fee increase for Internal Distributors is reasonable. While the Exchange has not increased the Distributor fees for TOPO Plus since its inception, the Exchange has added a number of functional enhancements since that time to TOPO and PHLX Orders in particular, and to Exchange systems in general. These enhancements, which are described in greater detail above, correspondingly enhance the value of the TOPO Plus data product. The proposed fee increase is therefore reflective of, and closely aligned to, these enhancements and the corresponding increased value of the TOPO Plus data product. The Exchange also believes that the amount of the fee increase is reasonable when comparing the amount of the proposed Internal Distributor fee to the amount of the current Internal Distributor fee and factoring in time and inflation.23 The Exchange also notes that the proposed Internal Distributor fee for TOPO Plus is still less than if an Internal Distributor purchased TOPO and PHLX Orders separately ($2,000 monthly for TOPO + $3,000 monthly for PHLX Orders).

    23 As noted above, TOPO Plus was launched in 2010. A $4,000 monthly fee with an interest rate increase of 2.85%, compounded annually for 8 years, would result in a fee of $5,000 monthly.

    The Exchange also believes that the proposed fee increase is equitably allocated, and is not designed to permit unfair discrimination between customers, issuers, brokers, or dealers. The Exchange makes all services and products subject to this fee available on a non-discriminatory basis to similarly-situated recipients, and the proposed fee increase here will apply equally to all entities that meet the definition of an Internal Distributor.

    The Exchange notes that it is only proposing to increase the fee for Internal Distributors, not for External Distributors, Non-Professional Subscribers, or Professional Subscribers. As noted above, the Exchange has made a number of product and system enhancements since the inception of TOPO Plus that have increased the value of that data product. While External Distributors have also received the benefit of these enhancements, the Exchange is not increasing the External Distributor fee at this time. The Exchange believes that this is equitable and not unfairly discriminatory for several reasons. First, a fee differential for external, as opposed to internal, distribution is well-recognized in the financial services industry as a reasonable distinction, and has been repeatedly accepted by the Commission as an equitable allocation of reasonable dues, fees and other charges.24 External Distributors already pay, and will continue to pay, a higher monthly fee than Internal Distributors.

    24See, e.g., Nasdaq Rules 7019 (Market Data Distributor Fees); 7022(c) (Short Interest Report); 7023(c) (Enterprise License Fees for Depth-of-Book Data); and 7052(c) (Distributor Fees for Nasdaq Daily Short Volume and Monthly Short Sale Transaction Files).

    Second, the Exchange believes that External Distributors of TOPO Plus, in comparison to Internal Distributors, may confer an additional benefit on market participants generally and the Exchange in particular. As the Exchange noted when it filed a proposed rule change to establish the fees for TOPO Plus, the higher fee for External Distributors in comparison to Internal Distributors reflected the fact that External Distributors had fewer limitations on their scope of distribution of TOPO Plus than Internal Distributors, and the reasonable expectation that External Distributors would distribute TOPO Plus to a higher number of subscribers than Internal Distributors; specifically, to Professional Subscribers who would use the data for commercial purposes.25 The Exchange believes that the value of external distribution of TOPO Plus extends beyond External Distributors to other market participants and to the Exchange as well. In distributing TOPO Plus externally, External Distributors provide market participants that purchase this product (and who may be unwilling or unable to purchase TOPO Plus as an Internal Distributor) with a greater awareness of order activity on the Exchange. This, in turn, may result in those market participants directing more order flow to the Exchange, benefitting both the Exchange and market participants that desire to transact on the Exchange. Currently, the majority of Distributors for TOPO Plus are Internal Distributors, with relatively few External Distributors. Given the increased benefits that may accompany the external distribution of TOPO Plus, and the Exchange's corresponding desire to retain External Distributor interest in TOPO Plus, the Exchange believes that it is equitable and not unfairly discriminatory to not impose a similar fee increase on External Distributors.

    25See Securities Exchange Act Release No. 61878 (April 8, 2010), 75 FR 20023 (April 16, 2010) (SR-Phlx-2010-48) (notice of filing).

    The Exchange also believes that it is equitable and not unfairly discriminatory to not assess a fee increase on Professional and Non-Professional Subscribers. By definition, Subscribers (either Professional or Non-Professional) are categorically different than Distributors (either Internal or External). The Exchange believes that it is equitable and not unfairly discriminatory to implement a fee increase for one category of market participants (Distributors) and not for another category of market participants (Subscribers), because these two categories are not similarly situated, both in terms of the fees that they pay, and the permissible ways in which they may use the data. Additionally, there is already a significant difference between the current amount paid by Non-Professional and Professional Subscribers ($1 and $40 monthly, respectively), and Internal and External distributors ($4,000 and $5,000, respectively).

    Finally, the Exchange notes that the Act does not prohibit all distinctions among customers, but rather discrimination that is unfair. As the Commission has recognized, “[i]f competitive forces are operative, the self-interest of the exchanges themselves will work powerfully to constrain unreasonable or unfair behavior.” 26 Accordingly, “the existence of significant competition provides a substantial basis for finding that the terms of an exchange's fee proposal are equitable, fair, reasonable, and not unreasonably or unfairly discriminatory.” 27 The proposed fee, like all market data fees, is constrained by the Exchange's need to compete for order flow as discussed below, and is subject to competition from other exchanges. If the Exchange is incorrect in its assessment of price, it will lose market share as a result.

    26 Securities Exchange Act Release No. 59039 (December 2, 2008), 73 FR 74770 (December 9, 2008) (SR-NYSEArca-2006-21).

    27Id.

    B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act. The proposed fee structure is designed to ensure a fair and reasonable use of Exchange resources by allowing the Exchange to recoup costs while continuing to offer its data products at competitive rates to firms.

    The Exchange does not believe that the proposed fee increase will impose any burden on intra-market competition that is not necessary or appropriate. As discussed above, the proposed increase to the Internal Distributor fee will apply equally to all market participants that qualify as Internal Distributors. While the Exchange is only proposing to increase the fee for Internal Distributors, the Exchange does not believe that this will impose a burden on intra-market competition, including on External Distributors that is not necessary or appropriate. The Exchange's rules set forth different standards for the use of Internal Distributor data versus External Distributor data, and this proposal does not alter those terms of use. As such, the Exchange does not believe that the proposal will impact the current competitive dynamic between Internal Distributors and External Distributors, to the extent such a dynamic exists. Moreover, the Exchange notes the majority of TOPO Plus subscribers are Internal Distributors; in not assessing a similar fee increase on External Distributors in order to encourage market participants to remain External Distributors, the Exchange is attempting to promote a more diverse ecosystem of market data Distributors. Finally, the Exchange notes that Distributors may always elect to not distribute TOPO Plus at all if they deem the distribution fee to be excessive.

    For the same reasons, the Exchange believes that the proposed fee increase does not impose a burden on Professional and Non-Professional Subscribers that is not necessary or appropriate. As discussed above, Professional and Non-Professional Subscribers are categorically different than Distributors, and have significantly different terms of usage for TOPO Plus than Distributors. As with Distributors, those terms of use remain unchanged by this proposal. Therefore, the Exchange does not believe that the proposal will impact that any competitive dynamic that may exist between Distributors and Subscribers.

    With respect to inter-market competition, the Exchange notes that the market for data products is extremely competitive and firms may freely choose alternative venues and data vendors based on the aggregate fees assessed, the data offered, and the value provided. This rule proposal does not burden competition, since other SROs and data vendors continue to offer alternative data products and, like the Exchange, set fees, but rather reflects the competition between data feed vendors and will further enhance such competition. TOPO Plus competes directly with existing similar products. The product is part of the existing market for proprietary last sale data products that is currently competitive and inherently contestable because there is fierce competition for the inputs necessary to the creation of proprietary data and strict pricing discipline for the proprietary products themselves. Numerous exchanges compete with each other for listings, trades, and market data itself, providing virtually limitless opportunities for entrepreneurs who wish to produce and distribute their own market data. This proprietary data is produced by each individual exchange, as well as other entities, in a vigorously competitive market.

    Transaction execution and proprietary data products are complementary in that market data is both an input and a byproduct of the execution service. In fact, market data and trade execution are a paradigmatic example of joint products with joint costs. The decision whether and on which platform to post an order will depend on the attributes of the platform where the order can be posted, including the execution fees, data quality and price, and distribution of its data products. Without trade executions, exchange data products cannot exist. Moreover, data products are valuable to many end users only insofar as they provide information that end users expect will assist them or their customers in making trading decisions.

    The costs of producing market data include not only the costs of the data distribution infrastructure, but also the costs of designing, maintaining, and operating the exchange's transaction execution platform and the cost of regulating the exchange to ensure its fair operation and maintain investor confidence. The total return that a trading platform earns reflects the revenues it receives from both products and the joint costs it incurs. Moreover, the operation of the exchange is characterized by high fixed costs and low marginal costs. This cost structure is common in content and content distribution industries such as software, where developing new software typically requires a large initial investment (and continuing large investments to upgrade the software), but once the software is developed, the incremental cost of providing that software to an additional user is typically small, or even zero (e.g., if the software can be downloaded over the internet after being purchased).

    In the Exchange's case, it is costly to build and maintain a trading platform, but the incremental cost of trading each additional share on an existing platform, or distributing an additional instance of data, is very low. Market information and executions are each produced jointly (in the sense that the activities of trading and placing orders are the source of the information that is distributed) and are each subject to significant scale economies. In such cases, marginal cost pricing is not feasible because if all sales were priced at the margin, the Exchange would be unable to defray its platform costs of providing the joint products.

    An exchange's broker-dealer customers view the costs of transaction executions and of data as a unified cost of doing business with the exchange. A broker-dealer will disfavor a particular exchange if the expected revenues from executing trades on the exchange do not exceed net transaction execution costs and the cost of data that the broker-dealer chooses to buy to support its trading decisions (or those of its customers). The choice of data products is, in turn, a product of the value of the products in making profitable trading decisions. If the cost of the product exceeds its expected value, the broker-dealer will choose not to buy it. Moreover, as a broker-dealer chooses to direct fewer orders to a particular exchange, the value of the product to that broker-dealer decreases, for two reasons. First, the product will contain less information, because executions of the broker-dealer's trading activity will not be reflected in it. Second, and perhaps more important, the product will be less valuable to that broker-dealer because it does not provide information about the venue to which it is directing its orders. Data from the competing venue to which the broker-dealer is directing more orders will become correspondingly more valuable.

    Similarly, in the case of products such as TOPO Plus that may be distributed through market data vendors, the vendors provide price discipline for proprietary data products because they control the primary means of access to end users. Vendors impose price restraints based upon their business models. For example, vendors such as Bloomberg and Reuters that assess a surcharge on data they sell may refuse to offer proprietary products that end users will not purchase in sufficient numbers. Internet portals, such as Google, impose a discipline by providing only data that will enable them to attract “eyeballs” that contribute to their advertising revenue. Retail broker-dealers, such as Schwab and Fidelity, offer their retail customers proprietary data only if it promotes trading and generates sufficient commission revenue. Although the business models may differ, these vendors' pricing discipline is the same: They can simply refuse to purchase any proprietary data product that fails to provide sufficient value. Exchanges and other producers of proprietary data products must understand and respond to these varying business models and pricing disciplines in order to market proprietary data products successfully. Moreover, the Exchange believes that products such as TOPO Plus can enhance order flow to the Exchange by providing more widespread distribution of information about transactions in real time, thereby encouraging wider participation in the market by investors with access to the internet or television. Conversely, the value of such products to Distributors and investors decreases if order flow falls, because the products contain less content.

    Competition among trading platforms can be expected to constrain the aggregate return each platform earns from the sale of its joint products, but different platforms may choose from a range of possible, and equally reasonable, pricing strategies as the means of recovering total costs. The Exchange pays rebates to attract orders, charges relatively low prices for market information and charges relatively high prices for accessing posted liquidity. Other platforms may choose a strategy of paying lower liquidity rebates to attract orders, setting relatively low prices for accessing posted liquidity, and setting relatively high prices for market information. Still others may provide most data free of charge and rely exclusively on transaction fees to recover their costs. Finally, some platforms may incentivize use by providing opportunities for equity ownership, which may allow them to charge lower direct fees for executions and data.

    In this environment, there is no economic basis for regulating maximum prices for one of the joint products in an industry in which suppliers face competitive constraints with regard to the joint offering. Such regulation is unnecessary because an “excessive” price for one of the joint products will ultimately have to be reflected in lower prices for other products sold by the firm, or otherwise the firm will experience a loss in the volume of its sales that will be adverse to its overall profitability. In other words, an increase in the price of data will ultimately have to be accompanied by a decrease in the cost of executions, or the volume of both data and executions will fall.

    Indeed, in approving the fees for TOPO Plus in 2010, the Commission noted that the Exchange was subject to competitive pressures in setting its fees for TOPO Plus. First, the Commission noted that the Exchange had a “compelling need” to attract order flow, which imposed “significant pressure” on the Exchange to act reasonably in setting its fees for PHLX market data, particularly given that “the market participants that will pay such fees often will be the same market participants from whom Phlx must attract order flow.” 28 The Commission also found that there were a number of alternative sources of information that imposed significant competitive pressures on the Exchange in setting the terms for distributing TOPO Plus. The Commission found that the availability of those alternatives, as well as the Exchange's compelling need to attract order flow, imposed “significant competitive pressure on Phlx to act equitably, fairly, and reasonably in setting the terms of its proposal.” 29 The Exchange believes that the same analysis and conclusions apply here.

    28See TOPO Plus approval order, 75 FR at 31833.

    29Id.

    In sum, the proposed fee structure is designed to ensure a fair and reasonable use of Exchange resources by allowing the Exchange to recoup costs while continuing to offer its data products at competitive rates to firms

    3. Self-Regulatory Organization's Statement on Comments on the Proposed Rule Change Received From Members, Participants, or Others

    No written comments were either solicited or received.

    III. Date of Effectiveness of the Proposed Rule Change and Timing for Commission Action

    The foregoing rule change has become effective pursuant to Section 19(b)(3)(A)(ii) of the Act.30

    30 15 U.S.C. 78s(b)(3)(A)(ii).

    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: (i) Necessary or appropriate in the public interest; (ii) for the protection of investors; or (iii) otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.

    IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:

    Electronic Comments

    • Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or

    • Send an email to [email protected] Please include File Number SR-Phlx-2018-08 on the subject line.

    Paper Comments

    • Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.

    All submissions should refer to File Number SR-Phlx-2018-08. 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 website (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 website viewing and printing in the Commission's Public Reference Room, 100 F Street NE, Washington, DC 20549 on official business days between the hours of 10:00 a.m. and 3:00 p.m. Copies of the filing also will be available for inspection and copying at the principal office of the Exchange. All comments received will be posted without change. Persons submitting comments are cautioned that we do not redact or edit personal identifying information from comment submissions. You should submit only information that you wish to make available publicly. All submissions should refer to File Number SR-Phlx-2018-08, and should be submitted on or before February 9, 2018.

    31 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.31

    Eduardo A. Aleman, Assistant Secretary.
    [FR Doc. 2018-00852 Filed 1-18-18; 8:45 am] BILLING CODE 8011-01-P
    SECURITIES AND EXCHANGE COMMISSION [Release No. 34-82501; File No. SR-OCC-2017-808] Self-Regulatory Organizations; The Options Clearing Corporation; Notice of No Objection to Advance Notice, as Modified by Amendment No. 1, Concerning the Adoption of a New Minimum Cash Requirement for the Clearing Fund January 12, 2018.

    The Options Clearing Corporation (“OCC”) filed on November 14, 2017 with the Securities and Exchange Commission (“Commission”) advance notice SR-OCC-2017-808 (“Advance Notice”) pursuant to Section 806(e)(1) of the Payment, Clearing, and Settlement Supervision Act of 2010 (“Payment, Clearing and Settlement Supervision Act”) 1 and Rule 19b-4(n)(1)(i) under the Securities Exchange Act of 1934 (“Exchange Act”) 2 to propose a new minimum cash contribution requirement for its Clearing Fund 3 (“Cash Clearing Fund Requirement”) and also provide for the pass-through of interest income earned on such deposits to its Clearing Members. The proposed changes are intended to enhance OCC's liquidity risk management by increasing the amount of qualifying liquid resources available, as well as to provide for a more consistent level of cash available in its prefunded financial resources. The Advance Notice was published for comment in the Federal Register on December 14, 2017.4 The Commission did not receive any comments on the Advance Notice. This publication serves as notice of no objection to the Advance Notice.

    1 12 U.S.C. 5465(e)(1). The Financial Stability Oversight Council designated OCC a systemically important financial market utility (“SIFMU”) on July 18, 2012. See Financial Stability Oversight Council 2012 Annual Report, Appendix A, http://www.treasury.gov/initiatives/fsoc/Documents/2012%20Annual%20Report.pdf. Therefore, OCC is required to comply with the Payment, Clearing and Settlement Supervision Act and file advance notices with the Commission.

    2 17 CFR 240.19b-4(n)(1)(i).

    3 Unless specified otherwise, capitalized terms shall have the meaning OCC ascribes in its By-Laws and Rules.

    4 Exchange Act Release No. 34-82247 (Dec. 8, 2017), 82 FR 59031 (Dec. 14, 2017) (“Notice of Filing of Advance Notice”).

    I. Background

    OCC maintains a Clearing Fund, composed of contributions required to be made by all Clearing Members, to make good losses suffered by OCC under a number of circumstances, including the default or failure of a Clearing Member to make good on any obligation for which OCC may be responsible in the exercise of its duties as a central counterparty. Presently, Article VIII, Section 3(a) of OCC's By-Laws provides that Clearing Fund contributions shall be in the form of cash and Government securities, but neither OCC's By-Laws nor Rules provides a minimum cash requirement for contributions to the Clearing Fund. Article VIII, Section 4(a) of OCC's By-Laws allows for OCC to invest cash contributions to the Clearing Fund, partially or wholly, in OCC's account in Government securities, and to the extent that such contributions are not so invested, they shall be deposited by OCC in a separate account or accounts for Clearing Fund contributions in approved custodians. Article VIII, Section 4(a) of OCC's By-Laws, however, presently does not account for the treatment of interest earned on cash deposits held in OCC's bank account at the Federal Reserve.

    II. Description of the Advance Notice A. Proposed Change To Establish the Cash Clearing Fund Requirement

    OCC proposes to establish a Cash Clearing Fund Requirement for its Clearing Fund to increase the amount of qualifying liquid resources available to OCC to account in the event there is an extreme scenario in the financial markets and OCC has to address any resultant liquidity demands. Further, the proposal seeks to ensure that OCC holds, and maintains access to, a more consistent level of cash clearing fund resources in its available prefunded financial resources. Specifically, the proposed rule change would require that Clearing Members collectively contribute $3 billion in cash to the Clearing Fund. Each Clearing Member's proportionate share of the Cash Clearing Fund Requirement shall be determined by the current Clearing Fund allocation methodology in OCC Rule 1001.

    OCC's current liquidity resources are sized to cover historically observed liquidity demands and potential demands based on forecasts with a 12 month time horizon. The sizing calculations, in turn, are based on the potential exposure resulting from the default of a single clearing member. Further, the current clearing fund is sized, at a minimum, to ensure that OCC maintains sufficient collateral to access its committed liquidity facilities. OCC represented that it maintains committed liquidity facilities of $3 billion to cover its calculated historical and forecasted demands.5

    5See Exchange Act Release No. 81058 (June 30, 2017), 82 FR 31371 (July 6, 2017) (SR-OCC-2017-803); Exchange Act Release No. 76641 (December 14, 2015), 80 FR 79114 (December 18, 2015) (SR-OCC-2015-805). Both facilities allow OCC to obtain cash in exchange for government securities 60 minutes after notice is given and collateral is posted.

    After analyzing its liquidity demands in extreme stress scenarios,6 OCC determined that it would propose the $3 billion Cash Clearing Fund Requirement to increase the amount and reliability of its liquid resources. OCC represented that, based upon its analysis, the peak stressed liquidity demands of the largest or two largest Clearing Members, which normally occur in conjunction with certain monthly expirations, could exceed the capacity of OCC's current committed liquidity facilities. Although OCC believes that it would be able to cover the resulting shortfall with cash already present in the Clearing Fund, OCC stated that it could not rely on such cash always being available because, under OCC's current By-Laws and Rules, there is no ability for OCC to ensure that a minimum amount of cash is maintained in the Clearing Fund at all times. As a result, OCC believes that the proposed $3 billion Cash Clearing Fund Requirement, combined with OCC's $3 billion of committed liquidity facilities, would provide liquid resources sufficient to cover the peak stressed liquidity demands of the largest one or two Clearing Members observed in the analysis.

    6 OCC represented that it performed an analysis of its stress liquidity demands based on a 1-in-70 year hypothetical market event. Specifically, OCC started its analysis by selecting the largest historical peak monthly settlements that occurred over the historical look-back period of data generated by the stress test system. It then also selected certain large non-expiration days to supplement the analysis. From this it estimated the mark-to-market and cash settled exercise and assignment obligations for the members driving the historical peak demand under the proposed stress tests scenario to determine the stressed peak demand.

    B. Proposed Change To Allow Temporary Increase of Cash Clearing Fund Requirement

    The proposed change would also provide authority for OCC to temporarily increase the amount of the Cash Clearing Fund Requirement. OCC's Executive Chairman, Chief Administrative Officer (“CAO”), or Chief Operating Officer (“COO”), would have the authority, upon providing notice to the Risk Committee, to temporarily raise the Cash Clearing Fund Requirement up to an amount that includes the size of the Clearing Fund as determined in accordance with Rule 1001 for the month in question. A Clearing Member will be required to satisfy any increase in its required cash contribution pursuant to an increase in the Cash Clearing Fund Requirement no later than one hour before the close of the Fedwire on the business day following OCC's issuance of an instruction to increase cash contributions.

    In such circumstances, the Risk Committee, by rule, would be obligated to review any such temporary increase as soon as practicable, but in any event within 20 calendar days of the increase. In its review, the Risk Committee shall determine whether (1) the increase in the minimum Cash Clearing Fund Requirement is no longer required, or (2) OCC's Clearing Fund contribution requirements and other related rules should be modified to ensure that OCC continues to maintain sufficient liquid resources to cover its largest aggregate payment obligations in extreme but plausible market conditions. In the event that the Risk Committee would determine to permanently increase the Cash Clearing Fund Requirement, OCC would initiate any regulatory approval process required to effect such a change.7

    7 However, OCC represented that it would not decrease the Cash Clearing Fund Requirement while the regulatory approvals for a change in the Cash Clearing Fund Requirement are being obtained to ensure that OCC continues to maintain sufficient liquid resources to cover its liquidity demands during that time.

    OCC acknowledged that increasing the Cash Clearing Fund Requirement could impose a liquidity constraint on its clearing members. Accordingly, OCC has proposed to limit the circumstances in which it could make such an increase. By rule, OCC would only be able to exercise this authority to protect OCC, its clearing members, or the general public. Further, any Cash Clearing Fund Requirement increase would have to: (i) Be based upon then-existing facts and circumstances, (ii) be in furtherance of the integrity of OCC and the stability of the financial system, and (iii) take into consideration the legitimate interests of Clearing Members and market participants.

    These changes would be reflected in new paragraph (a)(i) of Section 3 of Article VIII of OCC's By-Laws, as well as in new Interpretation and Policy .04 to Section 3 of Article VIII.

    C. Proposed Changes to Pass-Through Interest on Clearing Fund Cash to Clearing Members

    Under the proposal, OCC stated that substantially all the cash deposits in the Clearing Fund would be held in an account established by OCC at a Federal Reserve Bank. OCC proposes that it would pass the interest income earned in such account through to its Clearing Members. Specifically, OCC proposes to revise Article VIII, Section 4(a) of OCC's By-Laws to provide that any interest earned on cash deposits held at an account at the Federal Reserve shall accrue to the benefit of Clearing Members (calculated daily based on each Clearing Member's pro rata share of Clearing Fund cash deposits), provided that such Clearing Members have provided OCC with all tax documentation as OCC may from time to time require in order to effectuate such payment.

    To accommodate the pass through of interest income, OCC would also amend its Fee Policy to add definitions for “Pass-Through Interest Revenue” and “Operating Expenses” to exclude from the calculation of the Business Risk Buffer projected interest revenue and expense, respectively, related to the pass-through of earned interest from OCC to Clearing Members.8 OCC also proposes to add a new example of the Business Risk Buffer calculation reflecting this change and make clarifying changes throughout the policy to incorporate the use of the new defined terms. In addition, OCC proposes to amend the Fee Policy to remove references to “Proposed Rule 17Ad-22(e)(15)” to reflect the adoption of the Commission's Covered Clearing Agency Standards.

    8 While interest income earned by OCC from its bank account at the Federal Reserve would be passed on to its Clearing Members, OCC anticipates that it would charge a cash management fee to cover associated costs (i.e., administrative and similar costs). OCC would file a separate proposed rule change with the Commission, subject to receiving all necessary regulatory approvals for the proposed changes described herein, prior to implementing any cash management fee

    D. Proposed Conforming Changes

    In conjunction with the aforementioned changes, OCC is also proposing to make four related conforming changes. First, OCC proposes to revise Interpretation and Policy .01 of Rule 1001 to reflect that the new minimum Clearing Fund size is $3 billion (instead of $1 billion) plus 110% of the size of OCC's committed liquidity facilities, which conforms to the Cash Clearing Fund Requirement. Second, OCC proposes to amend the definition of “Approved Custodian” in Article I, Section 1 of the By-Laws to clarify that the Federal Reserve Bank may also be an Approved Custodian, to the extent it is available to OCC. Third, OCC is proposing to delete existing Article VIII, Section 4(b), regarding the establishment of a segregated funds account for cash contributions to the Clearing Fund. The segregated funds account allows a Clearing Member to contribute cash to a bank or trust company account maintained in the name of OCC, subject to OCC's exclusive control, but the account also includes the name of the Clearing Member and any interest accrues to the Clearing Member rather than OCC. OCC proposes to eliminate the account type because Clearing Members have not expressed interest in using such an account, no such accounts are in use today, and moving forward, substantially all cash Clearing Fund contributions will held in OCC's account at the Federal Reserve Bank. Fourth, OCC proposes to introduce new language to Article VIII, Section 4(a) to clarify that cash contributions to the Clearing Fund that are deposited at approved custodians may be commingled with the Clearing Fund contributions of different Clearing Members.

    III. Discussion and Commission Findings

    Although the Payment, Clearing and Settlement Supervision Act does not specify a standard of review for an advance notice, the stated purpose is instructive.9 The stated purpose of the Payment, Clearing and Settlement 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 SIFMUs and strengthening the liquidity of SIFMUs.10

    9 See 12 U.S.C. 5461(b).

    10Id.

    Section 805(a)(2) of the Payment, Clearing and Settlement Supervision Act 11 authorizes the Commission to prescribe regulations containing risk-management standards for the payment, clearing, and settlement activities of designated clearing entities engaged in designated activities for which the Commission is the supervisory agency. Section 805(b) of the Payment, Clearing and Settlement Supervision Act 12 provides the following objectives and principles for the Commission's risk-management standards prescribed under Section 805(a):

    11 12 U.S.C. 5464(a)(2).

    12 12 U.S.C. 5464(b).

    • To promote robust risk management;

    • To promote safety and soundness;

    • To reduce systemic risks; and

    • To support the stability of the broader financial system.

    Section 805(c) provides, in addition, that the Commission's risk-management standards may address such areas as risk-management and default policies and procedures, among others areas.13

    13 12 U.S.C. 5464(c).

    The Commission has adopted risk-management standards under Section 805(a)(2) of the Payment, Clearing and Settlement Supervision Act and the Exchange Act (the “Clearing Agency Rules”).14 The Clearing Agency Rules require each covered clearing agency, among other things, to establish, implement, maintain, and enforce written policies and procedures that are reasonably designed to meet certain minimum requirements for operations and risk-management practices on an ongoing basis. As such, it is appropriate for the Commission to review advance notices for consistency with the objectives and principles for risk-management standards described in Section 805(b) of the Payment, Clearing and Settlement Supervision Act and the Clearing Agency Rules.

    14 17 CFR 240.17Ad-22. See Securities Exchange Act Release No. 68080 (October 22, 2012), 77 FR 66220 (November 2, 2012) (S7-08-11). See also Securities Exchange Act Release No. 78961 (September 28, 2016), 81 FR 70786 (October 13, 2016) (S7-03-14) (“Covered Clearing Agency Standards”). The Commission established an effective date of December 12, 2016, and a compliance date of April 11, 2017, for the Covered Clearing Agency Standards. On March 4, 2017, the Commission granted covered clearing agencies a temporary exemption from compliance with Rule 17Ad-22(e)(3)(ii) and certain requirements in Rules 17Ad-22(e)(15)(i) and (ii) until December 31, 2017, subject to certain conditions. OCC is a “covered clearing agency” as defined in Rule 17Ad-22(a)(5).

    A. Consistency With Section 805(b) of the Payment, Clearing and Settlement Supervision Act

    The Commission believes the Advance Notice is consistent with the stated objectives and principles of Section 805(b) of the Payment, Clearing and Settlement Supervision Act of promoting robust risk management, promoting safety and soundness, reducing systemic risks, and supporting the stability of the broader financial system.15

    15 12 U.S.C. 5464(b).

    The Commission believes that the Cash Clearing Fund Requirement would enhance OCC's ability to manage its liquidity risk exposure, thereby promoting robust risk management. Similarly, the Commission believes that increasing the amount of cash, and therefore the overall amount of qualifying liquid resources, available to cover OCC's liquidity demands arising in stressed scenarios is consistent with promoting safety and soundness. Based on the analysis provided by OCC, the Commission believes that OCC's conclusion is reasonable, i.e., that under certain stressed conditions as set forth in the analysis, the peak stressed liquidity demands of the largest clearing member could exceed the size of OCC's committed liquidity facilities. Moreover, the Commission understands that OCC is unable to rely on the fact that there will always be deposits of cash in the Clearing Fund sufficient to cover such demands because, under its current By-laws and Rules, there is no ability for OCC to ensure that a minimum amount of cash is maintained in the Clearing Fund at all times. Therefore, there is a risk that OCC could face liquidity shortfalls in the event of a default by a clearing member whose payment obligations exceed OCC's liquid resources. OCC determined to address this risk by proposing to establish the Cash Clearing Fund Requirement. Establishing the Cash Clearing Fund Requirement would provide OCC with more qualifying liquid resources, which, in turn, enhances OCC's ability to cover payment obligations that could arise in stressed conditions. Further, the proposal to give OCC the authority to temporarily increase the Cash Clearing Fund Requirement gives OCC additional means to address liquidity shortfalls in extreme scenarios.

    The Commission also believes that the proposed changes are consistent with reducing systemic risks and supporting the stability of the broader financial system. OCC is the sole registered clearing agency for the U.S. listed options markets and a SIFMU. As such, it is important for OCC to implement measures that enhance its ability to manage risks that could cause a financial loss or settlement disruption and threaten the stability of the U.S. listed options markets and the broader financial system. The Commission believes that the proposed change is designed to enhance OCC's ability to continue to make timely settlement of payment obligations and otherwise service the U.S. options markets while in the midst of experiencing an extreme market event in the form of the default of up to two of its largest clearing members. As such, the Commission believes the proposed change is consistent with reducing systemic risks and supporting the stability of the broader financial system.

    B. Consistency With Rules 17Ad-22(e)(7)(i), (iii), and (viii) Under the Exchange Act

    The Commission further believes that the proposed change is consistent with the Covered Clearing Agency Standards, specifically Rule 17Ad-22(e)(7), which requires that a covered clearing agency establish, implement, maintain and enforce written policies and procedures reasonably designed to effectively measure, monitor, and manage its liquidity risk. This includes measuring, monitoring, and managing the covered clearing agency's settlement and funding flows on an ongoing and timely basis, as well as its use of intraday liquidity.16 The Division believes that the proposed change is consistent with several particular sub-parts of Rule 17Ad-22(e)(7), which require that OCC's liquidity risk management policies and procedures be reasonably designed to achieve the following:

    16 17 CFR 240.17Ad-22(e)(7).

    • Maintaining sufficient liquid resources at the minimum in all relevant currencies to effect same-day and, where appropriate, intraday and multiday settlement of payment obligations with a high degree of confidence under a wide range of foreseeable stress scenarios that includes, but is not limited to, the default of the participant family that would generate the largest aggregate payment obligation for the covered clearing agency in extreme but plausible market conditions; 17

    17 17 CFR 240.17Ad-22(e)(7)(i).

    • using the access to accounts and services at a Federal Reserve Bank or other relevant central bank, when available and where the board of directors of the covered clearing agency has determined that it would be practical to enhance its management of liquidity risk; 18 and

    18 17 CFR 240.17Ad-22(e)(7)(iii).

    • addressing foreseeable liquidity shortfalls that would not be covered by a covered clearing agency's liquid resources and seeking to avoid unwinding, revoking, or delaying the same-day settlement of payment obligations.19

    19 17 CFR 240.17Ad-22(e)(7)(viii).

    By proposing the Cash Clearing Fund Requirement, OCC has taken measures consistent with the standard in Rule 17Ad-22(e)(7)(i). OCC also represented that substantially all of OCC's Clearing Fund deposits consisting of cash would be held in an account established by OCC at a Federal Reserve Bank and further clarified that interest earned in such an account would be paid to its members on a specified basis. By proposing to use its access to accounts at a Federal Reserve Bank to support the maintenance of the Cash Clearing Fund Requirement, OCC has taken measures consistent with the standard in Rule 17Ad-22(e)(7)(iii) which provides for using access to a central bank account, where available and determined to be practical. Further, the proposed authority to temporarily increase the Cash Clearing Fund Requirement is intended to address a foreseeable liquidity shortfall and is therefore consistent with the requirement in Rule 17Ad-22(e)(7)(viii). IV. Conclusion

    It is therefore noticed, pursuant to Section 806(e)(1)(G) of the Payment, Clearing and Settlement Supervision Act,20 that the Commission does not object to Advance Notice (SR-OCC-2017-808) and that OCC is authorized to implement the proposed change.

    20 12 U.S.C. 5465(e)(1)(G).

    By the Commission.

    Brent J. Fields, Secretary.
    [FR Doc. 2018-00857 Filed 1-18-18; 8:45 am] BILLING CODE 8011-01-P
    SECURITIES AND EXCHANGE COMMISSION [Release No. 34-82497; File No. SR-ICEEU-2017-017] Self-Regulatory Organizations; ICE Clear Europe Limited; Notice of Proposed Rule Change, Security-Based Swap Submission or Advance Notice Relating to the ICE Clear Europe Wind Down Framework and Plan (the “Wind-Down Plan” or the “Plan”), as Most Recently Amended January 12, 2018.

    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 December 29, 2017, ICE Clear Europe Limited (“ICE Clear Europe”) filed with the Securities and Exchange Commission (“Commission”) the proposed rule changes described in Items I, II and III below, which Items have been prepared 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, Security-Based Swap Submission, or Advance Notice

    Consistent with its obligations under applicable laws and regulations,3 ICE Clear Europe has adopted its Wind-Down Plan, which is intended to address scenarios in which the clearing house determines to wind down, in an orderly fashion, its clearing services.

    3 As discussed in further detail herein, ICE Clear Europe is required to establish a wind-down plan under relevant provisions of the UK Financial Services and Markets Act 2000 (Recognition Requirements for Investment Exchanges and Clearing Houses) Regulations 2001 (SI/2001/1995) and Commission Rule 17Ad-22(e)(3)(ii), 17 CFR 240.17Ad-22(e)(3)(ii).

    The Plan is also designed to be consistent with the Committee on Payments and Market Infrastructures (“CPMI”)—International Organization of Securities Commissions (“IOSCO”) Principles for Financial Market Infrastructures (“PFMIs”), including supplemental guidance from CPMI-IOSCO which includes its report on “Recovery of financial market infrastructures” published in October 2014 and revised July 2017 (the “Recovery Guidance”).

    II. Clearing Agency's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change, Security-Based Swap Submission or Advance Notice

    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, Security-Based Swap Submission or Advance Notice (a) Purpose

    Consistent with its obligations under applicable laws and regulations, ICE Clear Europe has adopted a Wind-Down Plan. A wind-down may result from situations where neither ICEU's Recovery Plan 4 nor application of its loss allocation rules have succeeded in stemming default losses or non-default losses incurred by the clearing house, and as a result the clearing house cannot remain viable as a going concern. The Wind-Down Plan is also intended to address scenarios in which the clearing house, for business reasons, decides that it no longer wishes to operate as a clearing agency, and therefore may need to conduct an orderly wind-down of its business. The Wind-Down Plan is based on, and is intended to be consistent with, ICE Clear Europe's Clearing Rules (the “Rules”) 5 and Procedures, as well as its existing risk management frameworks, policies and procedures.

    4See SR-ICEEU-2017-016, filed December 2017.

    5 Capitalized terms used but not defined herein have the meanings specified in the Rules.

    Wind-Down Scenarios

    The Plan addresses three particular categories of scenarios in which wind-down may occur:

    1. Non-insolvency scenario: In this scenario, the ICE Clear Europe Board voluntarily decides to wind down the clearing business (for example, if it were to determine that clearing house's business model had become unviable) (a “voluntary unwind”).

    2. Insolvency scenario not linked to a member default: In this scenario, the clearing house would be wound down as a result of a severe loss unrelated to a clearing member default (a “non-default loss”) that could not be addressed through the Recovery Plan or other means that permit continued operation. Such a non-default loss could result from fraud or similar circumstances.

    3. Insolvency scenario linked to a member default: In this scenario, the clearing house would be wound down as a result of losses from the default of one or more clearing members that could not be addressed through the Recovery Plan or other means that permit continued operation, in accordance with the relevant default rules.

    In relation to each of these scenarios, the Plan provides for consideration of (i) winding down the clearing service in an orderly manner to close out contracts while minimizing the impact on clearing members and markets cleared, (ii) ensuring risk continues to be effectively managed during any wind-down period, and (iii) exiting all contractual obligations (both within the ICE group and with third parties, including exchanges, payment banks, custodians, investment counterparties and service providers). It is contemplated that the clearing house would take into account input from clearing members and exchanges on their preferences in connection with any decision to wind down or as to the means of wind down. The Plan also addresses a timeline of decision-making processes and notice periods, among other matters, proposed treatment of positions of different maturities, and the interaction of cleared positions with the unwinding of treasury investments and ongoing cash management. The Plan presumes that initial and variation margin will continue to be collected and paid (by non-defaulting clearing member) normally until contracts are terminated.

    The Wind-Down Plan is prepared on the basis that no resolution or similar proceeding occurs with respect to the clearing house in any jurisdiction.

    Wind-Down Options

    The Wind-Down Plan sets out a variety of options for wind-down, depending on the scenario involved. In the case of an insolvency of ICE Clear Europe as a result of non-default losses, the Plan contemplates that all open contracts will be terminated and net sums calculated to be payable to or from each clearing member for each account category, in accordance with Rules 912-918 (for the F&O product category) or Rule 209 (for the CDS product category).

    For a voluntary unwind or an unwind following a clearing member default, the Wind-Down Plan contemplates that for each product category, ICE Clear Europe will either transfer clearing to another clearing house or terminate clearing. ICE Clear Europe can take different actions with respect to the two product categories, and in the event of a transfer F&O clearing need not be transferred to the same clearing house as CDS clearing. The ability to transfer clearing will depend on whether the relevant market and market participants desire, and are able, to continue trading and clearing of the relevant product through another clearing house, and on whether another clearing house can be found to take the product. Following the transfer and/or termination of clearing, ICE Clear Europe will wind down the remaining aspects of its business and contractual relationships.

    The Plan also addresses the timing of wind-down. Pursuant to the Rules, ICE Clear Europe must give advance notice of a proposed “Withdrawal Date” should it cease acting as a clearing house either generally or in relation to a particular exchange or class of contracts. In those circumstances such notice must be given at least four months in advance, unless any action by a regulator, delivery facility or market causes cessation to take effect within a shorter period. In other wind-down circumstances, one month's notice is required.

    Any decision to wind down is expected to be considered over a period of months, will involve consultation with members, potential alternative clearing houses, exchange and regulators, and will need approval by the ICE Clear Europe Board. The Plan contemplates that a specific execution plan will be developed for any wind-down, based on the relevant situation.

    Types of Execution Plans 1. Transfer of F&O Clearing

    Under this approach, an existing alternative clearing house with similar platform and capabilities (risk, operations and treasury) to that of ICE Clear Europe will agree to have ICE Clear Europe's F&O markets clearing transferred to it. The alternative clearing house will add any needed additional members and contracts to its platform, and having tested these additions, will have open positions and margin funds transferred to it on a specified date.

    The Plan takes into account that for ICE Clear Europe F&O contracts that are not currently cleared on the recipient clearing house's platform, the necessary clearing capability will be built and tested prior to transfer. Positions for which transfer cannot be arranged in this way could be terminated. The Plan outlines certain conditions that will be necessary for any transfer to occur. The Plan also outlines key steps would need to be taken, including communication with stakeholders (including members, regulators and exchanges), negotiation with the alternative clearing house, making strategic determinations as to what systems are to be transferred as between the exchange and clearing house, notices and required approvals, novation arrangements for positions being moved, building and testing of new systems, listing of new contracts at the recipient clearing house, transfer of position data, novating contracts, and transfer of available margin funds, among other steps, as applicable. This process is anticipated to take no more than six months based on experience with other clearing transfers.

    2. Termination of F&O Clearing

    Under this approach, ICE Clear Europe will terminate the clearing of contracts on a specified date, expected to be five months after notice is provided. Prior to that date, clearing members may unwind their contracts through market transactions, and trading and clearing would be expected to continue during the period. ICE Clear Europe will monitor positions regularly to ensure credit risk is not increasing. Any remaining trades at the five month point will be terminated at the end of day price. The Plan outlines certain key steps in the process, including with respect to communication with stakeholders and position monitoring.

    3. Transfer of CDS Clearing

    Under this approach, clearing of CDS contracts would be transferred to an alternative clearing house with a similar platform and capabilities. As with the transfer of F&O clearing, the alternative clearing house will add any needed additional members and contracts to its platform, and having tested these additions, will have open positions and margin funds transferred to it on a specified date. If that is not possible within the desired timeframe, an additional option, for CDS contracts that are not subject to a mandatory clearing obligation, would be to convert open positions into uncleared contracts, and then parties could resubmit those contracts for clearing to the new clearing house when ready.

    The Plan outlines certain conditions that will be necessary for any transfer to occur. The Plan also outlines key steps would need to be taken, including communication with stakeholders (including members, regulators and exchanges), negotiation with the alternative clearing house(s), notices and required regulatory approvals, development and execution of novation arrangements for positions to be transferred, building and testing of new systems, migrating open position data, novating contracts, and transfer of available margin funds, among other steps, as applicable. This process is anticipated to take no more than six months based on experience with other clearing transfers. ICE Clear Europe would continue to provide clearing and maintain risk, treasury and operations teams up to that point.

    4. Termination of CDS Clearing

    This option winds down ICE Clear Europe CDS clearing. ICE Clear Europe has more limited authority under the Rules to cause a tear-up of contracts in the CDS product category, and as a result the Plan contemplates that CDS clearing members would need to agree amongst themselves in advance as to the manner of and procedures for termination. If they cannot agree, the Board may decide to enforce termination in accordance with Rule 105.

    Following ICE Clear Europe's determination to terminate CDS clearing, it would establish a five month period for CDS clearing members to unwind their open positions. This could be done through trading by such clearing members in the market that offsets their positions, or if this is not possible, by negotiating the conversion of open matched positions into uncleared contracts (where mandatory clearing does not apply).

    This Plan specifies certain conditions, including obtains the necessary agreement of members. The Plan also outlines certain key steps, including notification of stakeholders of the decision to terminate, communication of matched open positions to members, and monitoring the reduction of positions of CDS clearing members during the five month termination period.

    5. Final Wind Down of ICE Clear Europe

    Once the decision to wind down ICE Clear Europe is made, six months' notice will be provided to terminate all service agreements and employee contracts. Consideration will be given to incentives to key staff to stay on through the wind down process.

    The Plan outlines the termination provisions and notice periods that apply under key agreements, including those with other ICE entities and with banks and custodians. The Plan also addresses liquidity considerations during the wind-down period, such that ICE Clear Europe will be able to obtain and maintain sufficient liquidity from its investment arrangements to support clearing during the wind-down period. In this regard, ICE maintains significant liquidity in cash and short-term instruments such that it expects to be able to meet liquidity needs during the period. ICE Clear Europe also runs liquidity stress scenarios that closely match the closing of trading positions in a wind down situation.

    Governance

    Once there is a possibility of wind down, or the ICE Clear Europe Board has agreed in principle to a wind-down, a Wind Down Planning Committee, including senior management, would be established. The Committee will have the following membership: Chair—Non-Executive Director or Board Chairperson; President; Chief Operating Officer; Chief Risk Officer; Chief Compliance Officer; and other advisors as appropriate, e.g., legal counsel. The Committee would be tasked with exploring with clearing members, exchanges, alternative clearing houses and regulators the relevant approaches to wind-down, with a goal of minimizing adverse impact on clearing members. The Plan outlines a number of considerations for both termination and transfer options that the Committee should explore. The Committee would report to the Board. This consultation process is designed to reflect the fact that in a wind down situation, the Plan would likely be affected by numerous additional considerations and could require adjustment and modification to match specific circumstances.

    The maintenance of the Plan is the responsibility of ICE Clear Europe's Chief Operating Officer and each time the scope of clearing services change or a planning assumption changes, the Plan will be updated. The Plan is reviewed annually by the Board Audit Committee and the full Board.

    (b) Statutory Basis

    ICE Clear Europe believes that the proposed amendments are consistent with the requirements of Section 17A of the Act 6 and the regulations thereunder applicable to it, including the standards under Rule 17Ad-22.7

    6 15 U.S.C. 78q-1.

    7 17 CFR 240.17Ad-22.

    Section 17A(b)(3)(F) of the Act 8 requires, among other things, that the rules of a clearing agency be designed to promote the prompt and accurate clearance and settlement of securities transactions and, to the extent applicable, derivative agreements, contracts, and transactions, the safeguarding of securities and funds in the custody or control of the clearing agency or for which it is responsible, and the protection of investors and the public interest. In addition, Rule 17Ad-22(e)(3)(ii) 9 requires that each covered clearing agency shall establish, implement, maintain and enforce written policies and procedures reasonably designed to, as applicable, maintain a sound risk management framework for comprehensively managing legal, credit, liquidity, operational, general business, investment, custody, and other risks that arise in or are borne by the covered clearing agency, which includes plans for the recovery and orderly wind-down of the covered clearing agency necessitated by credit losses, liquidity shortfalls, losses from general business risk, or any other losses.

    8 15 U.S.C. 78q-1(b)(3)(F).

    9 17 CFR 240.17Ad-22(e)(3)(ii).

    The Wind-Down Plan is designed to meet the requirements of Rule 17Ad-22(e)(3)(ii), and is further consistent with the requirements of the Act. The Wind-Down Plan considers scenarios in which the wind-down of the clearing services of ICE Clear Europe may be necessary or desirable, both voluntarily and as a result of default or non-default losses that cannot be resolved through the Recovery Plan. It sets out procedures for transferring or terminating clearing of both the CDS and F&O product categories in a wind-down scenario, as well as terminating related agreements and arrangements. The Wind-Down Plan also provides greater transparency to market participants, including clearing members, about the expected sequence and scope of actions that ICE Clear Europe may take in a wind-down scenario, and addresses procedures for consultations with clearing members and other relevant stakeholders. In ICE Clear Europe's view, the Plan thus meets the requirements of Rule 17Ad-22(e)(3)(ii). Furthermore, ICE Clear Europe views the Plan as a key aspect of its general risk management framework for severe loss scenarios, as it provides an orderly procedure for termination or transfer of clearing, and thereby promotes the protection of investors and the public interest, within the meaning of Section 17A(b)(3)(F) of the Act.

    ICE Clear Europe further notes the requirement in Rule 17Ad-22(e)(15) 10 to hold sufficient liquid net assets funded by equity to cover potential general business losses so that the covered clearing agency can continue operations and services as a going concern if those losses materialize, including by (i) determining the amount of liquid net assets funded by equity based upon its general business risk profile and the length of time required to achieve a recovery or orderly wind-down, as appropriate, of its critical operations and services if such action is taken, and (ii) holding liquid net assets funded by equity equal to the greater of either (x) six months of the covered clearing agency's current operating expenses, or (y) the amount determined by the board of directors to be sufficient to ensure a recovery or orderly wind-down of critical operations and services of the covered clearing agency, as contemplated by the plans established under Rule 17Ad-22(e)(3)(ii) of this section. ICE Clear Europe has determined that it believes any wind-down can be completed within six months, and that it holds equity capital at least sufficient to cover the costs of a wind-down of its clearing services under the Wind-Down Plan during that period, consistent with the requirements of Rule 17Ad-22(e)(15).11

    10 17 CFR 240.17Ad-22(e)(15).

    11 17 CFR 240.17Ad-22(e)(15)(i).

    (B) Clearing Agency's Statement on Burden on Competition

    ICE Clear Europe does not believe the proposed Wind-Down Plan would have any impact, or impose any burden, on competition not necessary or appropriate in furtherance of the purposes of the Act. The Wind-Down Plan does not itself change the rights or obligations of the clearing house or clearing members, and is based on the termination provisions set forth in the existing Rules. The Wind-Down Plan has been designed to meet specific regulatory requirements concerning wind-down planning, principally to address the circumstance where default or non-default losses are sufficiently severe that they cannot be addressed through the Recovery Plan and necessitate termination or transfer of clearing. ICE Clear Europe does not believe the amendments will impact competition among clearing members or other market participants, or affect the ability of market participants to access clearing generally. While implementation of the Wind-Down Plan, and in particular use of the plan in a severe loss scenario, would likely impose costs on clearing members or other market participants, such costs are consistent with the existing Rules, and in ICE Clear Europe's view, would be appropriate in light of a loss situation requiring wind-down of clearing in accordance with applicable regulations.

    (C) Clearing Agency's Statement on Comments on the Proposed Rule Change Received From Members, Participants or Others

    Written comments relating to the proposed amendments have not been solicited or received by ICE Clear Europe. ICE Clear Europe will notify the Commission of any comments received with respect to the proposed rule change.

    III. Date of Effectiveness of the Proposed Rule Change, Security-Based Swap Submission and Advance Notice 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.

    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 proposed rule change, security-based swap submission or advance notice 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-2017-017 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-ICEEU-2017-017. 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 website (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all written statements with respect to the proposed rule change, security-based swap submission or advance notice that are filed with the Commission, and all written communications relating to the proposed rule change, security-based swap submission or advance notice between the Commission and any person, other than those that may be withheld from the public in accordance with the provisions of 5 U.S.C. 552, will be available for website viewing and printing in the Commission's Public Reference Section, 100 F Street NE, Washington, DC 20549, on official business days between the hours of 10:00 a.m. and 3:00 p.m. Copies of such filings will also be available for inspection and copying at the principal office of ICE Clear Europe and on ICE Clear Europe's website 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-2017-017 and should be submitted on or before February 9, 2018.

    For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.12

    12 17 CFR 200.30-3(a)(12).

    Eduardo A. Aleman, Assistant Secretary.
    [FR Doc. 2018-00854 Filed 1-18-18; 8:45 am] BILLING CODE 8011-01-P
    SECURITIES AND EXCHANGE COMMISSION [Release No. 34-82492; File No. SR-NYSEArca-2017-87] Self-Regulatory Organizations; NYSE Arca, Inc.; Order Granting Approval of a Proposed Rule Change, as Modified by Amendment No. 6, To List and Trade Shares of the JPMorgan Long/Short ETF Under NYSE Arca Rule 8.600-E January 12, 2018. I. Introduction

    On September 26, 2017, NYSE Arca, Inc. (“Exchange” or “NYSE Arca”) 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 list and trade shares (“Shares”) of the JPMorgan Long/Short ETF (“Fund”) under NYSE Arca Rule 8.600-E. The proposed rule change was published for comment in the Federal Register on October 16, 2017.3 On November 17, 2017, the Exchange filed Amendment No. 1 to the proposed rule change, and on November 27, 2017, the Exchange filed Amendment No. 2 to the proposed rule change. On November 29, 2017, pursuant to Section 19(b)(2) of the Act,4 the Commission designated a longer period within which to approve the proposed rule change, disapprove the proposed rule change, or institute proceedings to determine whether to disapprove the proposed rule change.5 On December 4, 2017, the Exchange filed Amendment No. 3 to the proposed rule change. On December 6, 2017, the Exchange filed Amendment No. 4 to the proposed rule change. On December 26, 2017, the Exchange filed Amendment No. 5 to the proposed rule change. On January 3, 2018, the Exchange filed Amendment No. 6 to the proposed rule change.6 The Commission has received no comments on the proposed rule change. This order approves the proposed rule change, as modified by Amendment No. 6.

    1 15 U.S.C. 78s(b)(1).

    2 17 CFR 240.19b-4.

    3See Securities Exchange Act Release No. 81842 (October 10, 2017), 82 FR 48127.

    4 15 U.S.C. 78s(b)(2).

    5See Securities Exchange Act Release No. 82176, 82 FR 57497 (December 5, 2017). The Commission designated January 14, 2018, as the date by which it shall approve or disapprove, or institute proceedings to determine whether to disapprove, the proposed rule change.

    6 In Amendment No. 6, which amended and superseded the proposed rule change as modified by Amendment Nos. 1, 2, 3, 4 and 5, the Exchange: (1) Changed the name of the Fund; (2) represented that the Trust will file an amendment to the Registration Statement (as defined herein) as necessary to conform to the representations in the filing; (3) clarified the definitions of certain return factors the Adviser (as defined herein) may utilize as part of the Fund's investment strategy; (4) moved cash and cash equivalents from the “other investments” category to the “principal investments” category; (5) provided that the Fund may purchase and sell foreign exchange-traded futures on foreign equities and foreign stock indexes and foreign exchange-traded options on foreign equity futures as part of its principal investments; (6) clarified that no more than 10% of the equity weight of the Fund's portfolio will be invested in non-exchange-traded American Depositary Receipts; (7) provided additional information regarding the Fund's holding of non-exchange-traded contingent value rights, including that such holdings would be limited to 0.5% of the Fund's assets by market value and that such holdings would not meet the criteria of Commentary .01(a)(1)(E) and (a)(2)(E) to NYSE Arca Rule 8.600-E, as further described herein; (8) provided that the Fund's investment in sovereign obligations and obligations of supranational entities each is not expected to exceed 5% of the Fund's assets; (9) provided additional information regarding the availability of information for the Shares; and (10) made other clarifications, corrections, and technical changes. Amendment No. 6 is not subject to notice and comment because it does not materially alter the substance of the proposed rule change or raise unique or novel regulatory issues. All of the amendments to the proposed rule change are available at https://www.sec.gov/comments/sr-nysearca-2017-87/nysearca201787.htm.

    II. The Exchange's Description of the Proposed Rule Change, as Modified by Amendment No. 6 7

    7 For more information regarding the Fund and the Shares, see Amendment No. 6, supra note 6.

    The Exchange proposes to list and trade Shares of the Fund under NYSE Arca Rule 8.600-E, which governs the listing and trading of Managed Fund Shares on the Exchange. The Fund is a series of J.P. Morgan Exchange-Traded Fund Trust (“Trust”), a Delaware statutory trust.8 J.P. Morgan Investment Management Inc. (“Adviser”) will be the investment adviser to the Fund and will also provide administrative services for and oversee the other service providers for the Fund.9 JPMorgan Distribution Services, Inc. will be the distributor of the Fund's Shares.

    8 The Trust is registered under the Investment Company Act of 1940 (“1940 Act”). On July 18, 2017, the Trust filed with the Commission an amendment to its registration statement on Form N-1A under the Securities Act of 1933 and the 1940 Act relating to the Fund (File Nos. 333-191837 and 811-22903) (“Registration Statement”). The Exchange represents that the Trust will file an amendment to the Registration Statement as necessary to conform to representations in the Exchange's filing. In addition, the Commission has issued an order granting certain exemptive relief to the Trust under the 1940 Act. See Investment Company Act Release No. 31990 (February 9, 2016) (“Exemptive Order”). The Exchange represents that investments made by the Fund will comply with the conditions set forth in the Exemptive Order.

    9 The Adviser is a wholly-owned subsidiary of JPMorgan Asset Management Holdings Inc., which is an indirect, wholly-owned subsidiary of JPMorgan Chase & Co., a bank holding company. The Adviser is not registered as a broker-dealer, but is affiliated with a broker-dealer and has implemented and will maintain a fire wall with respect to such broker-dealer affiliate regarding access to information concerning the composition of and/or changes to the Fund's portfolio. In the event (a) the Adviser becomes registered as a broker-dealer or newly affiliated with one or more broker-dealers, or (b) any new adviser or sub-adviser is a registered broker-dealer or becomes affiliated with a broker-dealer, it will implement and maintain a fire wall with respect to its relevant personnel or its broker-dealer affiliate regarding access to information concerning the composition of and/or changes to the portfolio, and will be subject to procedures designed to prevent the use and dissemination of material non-public information regarding such portfolio.

    According to the Exchange, the Fund will seek to provide long-term total return. Under normal market conditions,10 the Fund will employ the “Equity Long/Short” strategy to access certain return factors.11 The strategy will involve simultaneously investing in equities (investing long) that the Adviser believes are attractive based on relevant return factors and selling equities (selling short) that the Adviser believes are unattractive based on relevant return factors. The Fund will generally invest its assets globally to gain exposure, either directly or through the use of derivatives, to equity securities (across market capitalizations) in developed markets.12

    10 The term “normal market conditions” is defined in NYSE Arca Rule 8.600-E(c)(5).

    11 Each return factor represents a potential source of investment return that results from, among other things, assuming a particular risk or taking advantage of a behavioral bias. The exposure to individual return factors may vary based on the market opportunity of the individual return factors. For example, the return factors that the Adviser may utilize include, but are not limited to: Value (seek to purchase “cheap” stocks based on the ratios of their price to certain company characteristics and sell short stocks that are relatively more expensive based on the same considerations); Momentum (seek to capture the tendency that a security's recent performance may continue in the near future); Size (seek to purchase small cap stocks and sell short large cap stocks); Quality (seek to buy high quality stocks and sell short lower ranked stocks).

    12 Under normal market conditions, the Adviser currently expects that a significant portion of the Fund's exposure will be attained through the use of derivatives in addition to its exposure through direct investment. Derivatives will primarily be used as an efficient means of implementing a particular strategy in order to gain exposure to a desired return factor. Derivatives may also be used to increase gain, to effectively gain targeted exposure from cash positions, to hedge various investments, and/or for risk management.

    A. Principal Investments

    According to the Exchange, under normal market conditions, at least 80% of the Fund's assets will be invested in the securities and financial instruments described below.

    The Fund may invest in U.S. and foreign exchange-listed common stocks of U.S. and foreign corporations, U.S. and foreign exchange-listed preferred stocks of U.S. and foreign corporations, U.S. and foreign exchange-listed warrants of U.S. and foreign corporations, U.S. and foreign exchange-listed rights of U.S. and foreign corporations, and U.S. and foreign exchange-listed master limited partnerships (“MLPs”).

    The Fund may purchase and sell U.S. exchange-traded futures on U.S. and foreign equities, U.S. exchange-traded options on U.S. and foreign equity futures, and U.S. exchange-traded futures on U.S. and foreign stock indexes, foreign exchange-traded futures on foreign equities and foreign stock indexes, and foreign exchange-traded options on foreign equity futures.

    The Fund may invest in over-the-counter (“OTC”) and U.S. exchange-traded call and put options on equity securities and equity securities indexes.

    The Fund may invest in OTC total return swaps on U.S. and foreign equities and U.S. and foreign equity indices.

    The Fund may invest in forward currency transactions. Such investments consist of non-deliverable forwards, foreign forward currency contracts, caps, and floors.

    The Fund may invest in exchange-listed real estate investment trusts (“REITs”) that will be traded on U.S. national securities exchanges and on non-U.S. exchanges.

    The Fund may invest in U.S. and foreign exchange-listed and OTC Depositary Receipts.13

    13 Depositary Receipts include American Depositary Receipts (“ADRs”), Global Depositary Receipts, and European Depositary Receipts. No more than 10% of the equity weight of the Fund's portfolio will be invested in non-exchange traded ADRs.

    The Fund may invest in OTC-traded convertible securities (bonds or preferred stock that can convert to common stock).

    The Fund may invest in cash and cash equivalents, which are investments in money market funds (including funds for which the Adviser and/or its affiliates may serve as investment adviser or administrator), bank obligations,14 and commercial paper.

    14 Bank obligations include bankers' acceptances, certificates of deposit, and time deposits.

    B. Other Investments

    While the Fund, under normal market conditions, will invest at least 80% of its assets in the securities and financial instruments described above, the Fund may invest its remaining assets in other assets and financial instruments, as described below.

    The Fund may invest in U.S. Government obligations, which may include direct obligations of the U.S. Treasury, including Treasury bills, notes, and bonds, all of which are backed as to principal and interest payments by the full faith and credit of the United States, and separately traded principal and interest component parts of such obligations that are transferable through the Federal book-entry system known as Separate Trading of Registered Interest and Principal of Securities and Coupons Under Book Entry Safekeeping.

    The Fund may invest in U.S. and foreign corporate debt.

    The Fund may invest in sovereign obligations, which are investments in debt obligations issued or guaranteed by a foreign sovereign government or its agencies, authorities, or political subdivisions. The Fund may also invest in obligations of supranational entities, including securities designated or supported by governmental entities to promote economic reconstruction or development of international banking institutions and related government agencies.

    The Fund may invest in spot currency transactions.

    The Fund may hold non-exchange-traded contingent value rights (“CVRs”).15

    15 The Exchange states that, for the purposes of the filing, CVRs are rights provided to shareholders of a company in connection with a corporate restructuring or acquisition. These rights relate to additional benefits to shareholders if a certain event occurs. CVRs frequently have an expiration date relating to the times that contingent events must occur. CVRs related to a company's stock are generally related to the price performance of such stock.

    The Fund may invest in Rule 144A securities and Regulation S securities.

    C. Investment Restrictions

    The Fund's investments, including derivatives, will be consistent with the Fund's investment objective and will not be used to enhance leverage (although certain derivatives and other investments may result in leverage). That is, while the Fund will be permitted to borrow as permitted under the 1940 Act, the Fund's investments will not be used to seek performance that is the multiple or inverse multiple (e.g., 2Xs and 3Xs) of the Fund's primary broad-based securities benchmark index (as defined in Form N-1A).16

    16 The Fund's broad-based securities benchmark index will be identified in a future amendment to the Registration Statement following the Fund's first full calendar year of performance.

    D. Application of Generic Listing Requirements

    According to the Exchange, the Fund's portfolio will not meet all of the generic listing requirements of Commentary .01 to NYSE Arca Rule 8.600-E. Specifically, the Fund will meet all the requirements of NYSE Arca Rule 8.600-E except for those set forth in Commentary .01(a)(1)(E) and Commentary .01(a)(2)(E) relating to non-exchange-traded CVRs, Commentary .01(e), and Commentary .01(b)(3).

    Commentary .01(a)(1)(E) to NYSE Arca Rule 8.600-E requires that, on both an initial and continuing basis, the component stocks of the equity portion of a portfolio that are U.S. Component Stocks (as described in NYSE Arca Rule 5.2-E(j)(3)) be listed on a national securities exchange and be NMS Stocks as defined in Rule 600 of Regulation NMS under the Act.17 Commentary .01(a)(2)(E) to NYSE Arca Rule 8.600-E requires that, on both an initial and continuing basis, the component stocks of the equity portion of a portfolio that are Non-U.S. Component Stocks (as described in NYSE Arca Rule 5.2-E(j)(3)) be listed and traded on an exchange that has last-sale reporting. The Exchange states that the non-exchange-traded CVRs that the Fund may hold would not be listed on a national securities exchange or an exchange with last sale reporting, and therefore would not meet the criteria of Commentary .01(a)(1)(E) and Commentary .01(a)(2)(E). The Exchange states that the Adviser represents that the Fund may at times hold a de minimis amount of the Fund's assets (less than 0.5% by market value) in non-exchange-traded CVRs. The Exchange also states that the Adviser represents that the Fund will not actively invest in non-exchange-traded CVRs but may, at times, receive a distribution of such securities in connection with the Fund's holdings in other securities. According to the Exchange, therefore, the Fund's holdings in non-exchange-traded CVRs, if any, would not be utilized to further the Fund's investment objective and would not be acquired as the result of the Fund's voluntary investment decisions.

    17 Commentary .01(a)(1)(F) to NYSE Arca Rule 8.600-E provides that ADRs in a portfolio may be exchange-traded or non-exchange-traded, but no more than 10% of the equity weight of a portfolio may consist of non-exchange-traded ADRs.

    Commentary .01(e) to NYSE Arca Rule 8.600-E requires that, on both an initial and continuing basis, no more than 20% of the assets in the Fund's portfolio may be invested in OTC derivatives (calculated as the aggregate gross notional value of the OTC derivatives). The Exchange states that the aggregate gross notional value of the Fund's investments in OTC derivatives may exceed this limit. The Exchange states that the Adviser intends to engage in strategies that utilize OTC foreign currency forward transactions, OTC total return swaps, and OTC options. According to the Exchange, because foreign currency forward transactions and total return swaps will be traded OTC, it would not be possible to implement these strategies efficiently using listed derivatives. In addition, use of OTC options on equity securities and equity securities indexes may be an important means to reduce risk in the Fund's equity investments, or, depending on market conditions, to enhance returns of such investments. The Exchange states that if the Fund were limited to investing up to 20% of assets in OTC derivatives, the Fund would have to exclude or underweight these strategies and would be less diversified, concentrating risk in the other strategies it will utilize. In addition, the Exchange states that the Adviser represents that the Fund will follow an investment strategy utilized within the JP Morgan Diversified Alternative ETF, shares of which have previously been approved by the Commission for Exchange listing and trading.18

    18See Securities Exchange Act Release No. 77904 (May 25, 2016), 81 FR 35101 (June 1, 2016) (SR-NYSEArca-2016-17) (order approving listing and trading of shares of the JPMorgan Diversified Alternative ETF under NYSE Arca Equities Rule 8.600).

    Commentary .01(b)(3) to NYSE Arca Rule 8.600-E provides that a portfolio (excluding exempted securities) that includes fixed income securities shall include a minimum of 13 non-affiliated issuers, provided, however, that there shall be no minimum number of non-affiliated issuers required for fixed income securities if at least 70% of the weight of the portfolio consists of equity securities as described in Commentary .01(a) to NYSE Arca Rule 8.600-E. The Exchange states that the Fund's investment in fixed income securities will not meet this requirement. However, the Exchange represents that the Fund's investment in corporate debt will not exceed 5% of the Fund's assets, the Fund's investment in OTC-traded convertible securities also will not exceed 5% of the Fund's assets, and the Fund's investment in sovereign obligations and obligations of supranational entities each is not expected to exceed 5% of the Fund's assets. The Exchange also states the Adviser's belief that it is appropriate to permit a small investment in corporate debt, OTC-traded convertible securities, sovereign obligations, and obligations of supranational entities in order to permit the Fund to diversify its investments to enhance investor returns. According to the Exchange, because such investments would be limited and are not expected to exceed 20% of the Fund's assets in the aggregate, it would be difficult for the Fund to diversify such investments in order to comply with the requirement that fixed income securities include at least 13 non-affiliated issuers.

    III. Discussion and Commission's Findings

    After careful review, the Commission finds that the proposed rule change, as modified by Amendment No. 6, is consistent with the Act and the rules and regulations thereunder applicable to a national securities exchange.19 In particular, the Commission finds that the proposed rule change, as modified by Amendment No. 6, 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 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.

    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 15 U.S.C. 78f(b)(5).

    As noted above, the Fund's investment in non-exchange-traded CVRs would not comply with either Commentary .01(a)(1)(E) to NYSE Arca Rule 8.600-E, which requires the U.S. Component Stocks in the portfolio to be listed on a national securities exchange and to be NMS Stocks, or Commentary .01(a)(2)(E) to NYSE Arca Rule 8.600-E, which requires the Non-U.S. Component Stocks in the portfolio to be listed and traded on an exchange with last sale reporting. As proposed, the Fund may at times hold a de minimis amount of the Fund's assets (less than 0.5% by market value) in non-exchange-traded CVRs. Also, the Fund will not actively invest in non-exchange-traded CVRs but may, at times, receive a distribution of such securities in connection with the Fund's holdings in other securities.

    In addition, as noted above, the aggregate gross notional value of the Fund's investments in OTC derivatives may exceed the 20% limit in Commentary .01(e) to NYSE Arca Rule 8.600-E.21 The Exchange states that the 20% limit could result in the Fund being unable to fully pursue its investment objective while attempting to sufficiently mitigate investment risks. According to the Exchange, if the Fund were limited to investing up to 20% of its assets in OTC derivatives, the Fund would have to exclude or underweight the strategies utilizing OTC derivatives and the Fund would be less diversified, concentrating risk in the other strategies it plans to utilize.22 In addition, the Exchange states that the inability of the Fund to adequately hedge its holdings would effectively limit the Fund's ability to invest in certain instruments, or could expose the Fund to additional investment risk. The Exchange also states that suitable derivative transactions may be an efficient alternative for the Fund to obtain the desired asset exposure because the markets for certain assets, or the assets themselves, may be unavailable or cost prohibitive as compared to derivative instruments. Furthermore, the Exchange states that OTC derivatives may be tailored more specifically than the available listed derivatives to the assets held by the Fund.23 As proposed, on a daily basis, the Fund will disclose on its website the information regarding the Disclosed Portfolio required under NYSE Arca Rule 8.600-E(c)(2) to the extent applicable.24 The website information will be publicly available at no charge. The Exchange represents that the Fund's disclosure of derivative positions in the Disclosed Portfolio will include information that market participants can use to value the derivative positions intraday.

    21 The Exchange states that the Fund's investments in derivative instruments will be made in accordance with the 1940 Act and consistent with the Fund's investment objective and policies. To limit the potential risk associated with such transactions, the Fund will segregate or “earmark” assets determined to be liquid by the Adviser in accordance with procedures established by the Trust's Board of Trustees and in accordance with the 1940 Act (or, as permitted by applicable regulation, enter into certain offsetting positions) to cover its obligations under derivative instruments. The Exchange states that these procedures have been adopted consistent with Section 18 of the 1940 Act and related Commission guidance. In addition, the Fund will include appropriate risk disclosure in its offering documents, including leveraging risk.

    22 The Exchange states that the Adviser represents that it is not possible to implement its strategies efficiently using listed derivatives because the foreign currency forward transactions and total return swaps in which the Fund may invest will be traded OTC. The Exchange also states that use of OTC options on equity securities and equity securities indexes may be an important means to reduce risk in the Fund's equity investments.

    23 As noted above, the Adviser represents that the Fund will follow an investment strategy utilized by the JP Morgan Diversified Alternative ETF, shares of which were previously approved for Exchange listing and trading by the Commission. See supra note 18 and accompanying text.

    24 NYSE Arca Rule 8.600-E(c)(2) requires that the website for each series of Managed Fund Shares disclose the following information regarding the Disclosed Portfolio, to the extent applicable: (A) Ticker symbol; (B) CUSIP or other identifier; (C) description of the holding; (D) with respect to holdings in derivatives, the identity of the security, commodity, index or other asset upon which the derivative is based; (E) the strike price for any options; (F) the quantity of each security or other asset held as measured by (i) par value, (ii) notional value, (iii) number of shares, (iv) number of contracts, and (v) number of units; (G) maturity date; (H) coupon rate; (I) effective date; (J) market value; and (K) percentage weighting of the holding in the portfolio.

    Finally, as noted above, the Fund's investment in fixed income securities will not meet the requirement for 13 non-affiliated issuers in Commentary .01(b)(3) to NYSE Arca Rule 8.600-E. As proposed, the Fund's investment in corporate debt will not exceed 5% of the Fund's assets, the Fund's investment in OTC-traded convertible securities will not exceed 5% of the Fund's assets, and the Fund's investment in sovereign obligations and obligations of supranational entities each is not expected to exceed 5% of the Fund's assets. According to the Exchange, because these investments would be limited and are not expected to exceed 20% of the Fund's assets in the aggregate, it would be difficult for the Fund to diversify such investments in order to comply this requirement. The Exchange also states the Adviser's belief that it is appropriate to permit a small investment in corporate debt, OTC-traded convertible securities, sovereign obligations, and obligations of supranational entities in order to permit the Fund to diversify its investments to enhance investor returns.

    The Commission notes that, other than Commentary .01(a)(1)(E) and Commentary .01(a)(2)(E) relating to non-exchange-traded CVRs, Commentary .01(e), and Commentary .01(b)(3), the Fund will meet all the requirements of NYSE Arca Rule 8.600-E.

    The Commission also finds that the proposal is consistent with Section 11A(a)(1)(C)(iii) of the Act,25 which sets forth Congress's 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. Quotation and last-sale information for the Shares will be available via the CTA high-speed line. The Portfolio Indicative Value (“PIV”) for the Fund, as defined in NYSE Arca Rule 8.600-E(c)(3), will be widely disseminated by one or more major market data vendors at least every 15 seconds during the Exchange's Core Trading Session.26 Information regarding market price and trading volume for the Shares will be continually available on a real-time basis throughout the day on brokers' computer screens and other electronic services. Information regarding the previous day's closing price and trading volume information for the Shares will be published daily in the financial section of newspapers.

    25 15 U.S.C. 78k-1(a)(1)(C)(iii).

    26 Currently, it is the Exchange's understanding that several major market data vendors display and/or make widely available PIVs taken from the CTA or other data feeds.

    Quotation and last sale information for portfolio holdings of the Fund that are U.S. exchange-listed, including common stocks, warrants, rights, MLPs, preferred stocks, REITs, and Depositary Receipts will be available via the CTA high speed line. Quotation and last sale information for such U.S. exchange-listed securities, as well as U.S. and foreign exchange-traded futures and options on futures, will be available from the exchanges on which they are listed. Quotation and last sale information for exchange-listed options cleared via the Options Clearing Corporation will be available via the Options Price Reporting Authority. Quotation and last sale information for foreign exchange-listed equity securities will be available from the exchanges on which they trade and from major market data vendors, as applicable. Price information for preferred stocks and non-exchange-traded CVRs will be available from one or more major market data vendors or from broker-dealers. Quotation information for OTC options, cash equivalents, swaps, obligations of supranational agencies, money market funds, U.S. Government obligations, U.S. Government agency obligations, sovereign obligations, repurchase and reverse repurchase agreements, and U.S. and foreign corporate debt may be obtained from brokers and dealers who make markets in such securities or through nationally recognized pricing services through subscription agreements. The U.S. dollar value of foreign securities, instruments, and currencies can be derived by using foreign currency exchange rate quotations obtained from nationally recognized pricing services. Forwards and spot currency price information will be available from major market data vendors. Price information for OTC Depositary Receipts, convertible securities, 144A securities and Regulation S securities is available from major market data vendors. In addition, the Fund's website, which will be publicly available prior to the public offering of the Shares, will include a form of the prospectus for the Fund and additional data relating to NAV and other applicable quantitative information.

    The Commission also believes that the proposal is reasonably designed to promote fair disclosure of information that may be necessary to price the Shares appropriately and to prevent trading when a reasonable degree of transparency cannot be assured. The Exchange will obtain a representation from the issuer of the Shares that the NAV per Share will be calculated daily and that the NAV and the Disclosed Portfolio will be made available to all market participants at the same time. Trading in the Shares will be halted if the circuit-breaker parameters in NYSE Arca Rule 7.12-E have been reached. Trading also may be halted because of market conditions or for reasons that, in the view of the Exchange, make trading in the Shares inadvisable. Moreover, trading in the Shares will be subject to NYSE Arca Rule 8.600-E(d)(2)(D), which sets forth circumstances under which Shares may be halted.

    The Exchange states that it has a general policy prohibiting the distribution of material, non-public information by its employees. The Exchange states that the Adviser is not registered as a broker-dealer but is affiliated with a broker-dealer and has implemented and will maintain a fire wall with respect to that broker-dealer affiliate regarding access to information concerning the composition of and/or changes to the Fund's portfolio.27 Further, the Commission notes that the Reporting Authority that provides the Disclosed Portfolio must implement and maintain, or be subject to, procedures designed to prevent the use and dissemination of material, non-public information regarding the actual components of the portfolio.28

    27 The Exchange also represents that an investment adviser to an open-end fund is required to be registered under the Investment Advisers Act of 1940.

    28See NYSE Arca Rule 8.600-E(d)(2)(B)(ii).

    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. In support of this proposal, the Exchange represents that:

    (1) Other than Commentary .01(a)(1)(E) and Commentary .01(a)(2)(E) with respect to investments in non-exchange-traded CVRs, Commentary .01(e), and Commentary .01(b)(3), the Fund will meet all other requirements of NYSE Arca Rule 8.600-E.

    (2) A minimum of 100,000 Shares of the Fund will be outstanding at the commencement of trading on the Exchange.

    (3) Trading in the Shares will be subject to the existing trading surveillances administered by the Exchange, as well as cross-market surveillances administered by the Financial Industry Regulatory Authority (“FINRA”) on behalf of the Exchange, and these procedures are adequate to properly monitor Exchange trading of the Shares in all trading sessions and to deter and detect violations of Exchange rules and applicable federal securities laws.29

    29 The Exchange states that FINRA conducts cross-market surveillances on behalf of the Exchange pursuant to a regulatory services agreement, and that the Exchange is responsible for FINRA's performance under this regulatory services agreement.

    (4) The Exchange or FINRA, on behalf of the Exchange, or both, will communicate as needed regarding trading in the Shares, certain exchange-listed equity securities, certain futures, and certain exchange-traded options with other markets and other entities that are members of the Intermarket Surveillance Group (“ISG”), and the Exchange or FINRA, on behalf of the Exchange, or both, may obtain trading information regarding trading such securities and financial instruments from such markets and other entities. In addition, the Exchange may obtain information regarding trading in such securities and financial instruments from markets and other entities that are members of ISG or with which the Exchange has in place a comprehensive surveillance sharing agreement. FINRA, on behalf of the Exchange, is able to access, as needed, trade information for certain fixed income securities held by the Fund reported to FINRA's Trade Reporting and Compliance Engine.

    (5) Prior to the commencement of trading, the Exchange will inform its Equity Trading Permit Holders in an Information Bulletin of the special characteristics and risks associated with trading the Shares. Specifically, the Information Bulletin will discuss: (a) The procedures for purchases and redemptions of Shares in creation units (and that Shares are not individually redeemable); (b) NYSE Arca Rule 9.2-E(a), which imposes a duty of due diligence on its Equity Trading Permit Holders to learn the essential facts relating to every customer prior to trading the Shares; (c) the risks involved in trading the Shares during the Early and Late Trading Sessions when an updated PIV will not be calculated or publicly disseminated; (d) how information regarding the PIV and the Disclosed Portfolio is disseminated; (e) the requirement that Equity Trading Permit Holders deliver a prospectus to investors purchasing newly issued Shares prior to or concurrently with the confirmation of a transaction; and (f) trading information.

    (6) The Exchange has appropriate rules to facilitate transactions in the Shares during all trading sessions.

    (7) For initial and continued listing, the Fund will be in compliance with Rule 10A-3 under the Act.30

    30See 17 CFR 240.10A-3.

    (8) The Fund's investments, including derivatives, will be consistent with the Fund's investment objective and will not be used to enhance leverage. That is, while the Fund will be permitted to borrow as permitted under the 1940 Act, the Fund's investments will not be used to seek performance that is the multiple or inverse multiple (e.g., 2Xs and 3Xs) of the Fund's primary broad-based securities benchmark index (as defined in Form N-1A).

    The Exchange represents that all statements and representations made in the filing regarding: (1) The description of the portfolio holdings or reference assets; (2) limitations on portfolio holdings or reference assets; or (3) the applicability of Exchange listing rules specified in the rule filing constitute continued listing requirements for listing the Shares on the Exchange. In addition, the issuer has represented to the Exchange that it will advise the Exchange of any failure by the Fund to comply with the continued listing requirements and, pursuant to its obligations under Section 19(g)(1) of the Act, the Exchange will monitor 31 for compliance with the continued listing requirements. If the Fund is not in compliance with the applicable listing requirements, the Exchange will commence delisting procedures under NYSE Arca Rule 5.5-E(m).

    31 The Commission notes that certain proposals for the listing and trading of exchange-traded products include a representation that the exchange will “surveil” for compliance with the continued listing requirements. See, e.g., Securities Exchange Act Release No. 77499 (April 1, 2016), 81 FR 20428, 20432 (April 7, 2016) (SR-BATS-2016-04). In the context of this representation, it is the Commission's view that “monitor” and “surveil” both mean ongoing oversight of compliance with the continued listing requirements. Therefore, the Commission does not view “monitor” as a more or less stringent obligation than “surveil” with respect to the continued listing requirements.

    This approval order is based on all of the Exchange's statements and representations, including those set forth above and in Amendment No. 6.

    For the foregoing reasons, the Commission finds that the proposed rule change, as modified by Amendment No. 6, is consistent with Section 6(b)(5) of the Act 32 and Section 11A(a)(1)(C)(iii) of the Act 33 and the rules and regulations thereunder applicable to a national securities exchange.

    32 15 U.S.C. 78f(b)(5).

    33 15 U.S.C. 78k-1(a)(1)(C)(iii).

    IV. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the Act,34 that the proposed rule change (SR-NYSEArca-2017-87), as modified by Amendment No. 6, be, and it hereby is, approved.

    34 15 U.S.C. 78s(b)(2).

    35 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.35

    Eduardo A. Aleman, Assistant Secretary.
    [FR Doc. 2018-00849 Filed 1-18-18; 8:45 am] BILLING CODE 8011-01-P
    SECURITIES AND EXCHANGE COMMISSION [Release No. 34-82496; File No. SR-ICEEU-2017-016] Self-Regulatory Organizations; ICE Clear Europe Limited; Notice of Proposed Rule Change, Security-Based Swap Submission or Advance Notice Relating to the ICE Clear Europe Recovery Plan January 12, 2018.

    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 December 29, 2017, ICE Clear Europe Limited (“ICE Clear Europe”) filed with the Securities and Exchange Commission (“Commission”) the proposed rule changes described in Items I, II and III below, which Items have been prepared 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, Security-Based Swap Submission, or Advance Notice

    Consistent with its obligations under applicable laws and regulations,3 ICEU has adopted a Recovery Plan identifying certain critical clearing services it provides and addressing its tools, mechanisms and options for addressing scenarios that threaten its ability to continue to provide such services.

    3 As discussed in further detail herein, ICE Clear Europe is required to establish a recovery plan under relevant provisions of the UK Financial Services and Markets Act 2000 (Recognition Requirements for Investment Exchanges and Clearing Houses) Regulations 2001 (SI/2001/1995) and Commission Rule 17Ad-22(e)(3)(ii), 17 CFR 240.17Ad-22(e)(3)(ii).

    The Plan is also designed to be consistent with the Committee on Payments and Market Infrastructures (“CPMI”)—International Organization of Securities Commissions (“IOSCO”) Principles for Financial Market Infrastructures (“PFMIs”), including supplemental guidance from CPMI-IOSCO which includes its report on “Recovery of financial market infrastructures” published in October 2014 and revised July 2017 (the “Recovery Guidance”).

    II. Clearing Agency's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change, Security-Based Swap Submission or Advance Notice

    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, Security-Based Swap Submission or Advance Notice (a) Purpose

    Consistent with its obligations under applicable laws and regulations, ICE Clear Europe has adopted a Recovery Plan. The Recovery Plan is based on, and is intended to be consistent with, ICEU's Clearing Rules (the “Rules”) 4 and Procedures, as well as its existing risk management frameworks, policies and procedures.

    4 Capitalized terms used but not defined herein have the meanings specified in the Rules.

    Overview of the Recovery Plan

    The Recovery Plan identifies the critical services that ICEU provides, and the business functions that support those services. In ICEU's view, its clearing services (for both the F&O and CDS product categories), and its related treasury and banking services, represent its critical services. The Recovery Plan outlines a number of firm-specific and market-wide stress scenarios that, in ICEU's determination, may result in significant losses or liquidity shortfall, suspension or failure of its critical services and related functions and systems, and damage to other market infrastructure, with resulting uncertainty in the markets for which ICEU clears. These include both losses from Clearing Member default and non-default loss scenarios. The Recovery Plan further evaluates different impact categories and severity levels of these stress scenarios. The Recovery Plan then addresses the tools, mechanisms and options (“Recovery Options”) upon which ICEU may draw (based on its existing Rules, Procedures and policies and frameworks) in order to address a stress scenario and continue to provide its critical services, and the actions to implement those options (including appropriate escalation and early warning procedures). The Recovery Plan also addresses communication with regulators and other relevant stakeholders and related governance issues. The Recovery Plan further considers the implications of certain situations that may be beyond its control, such as interdependencies with other institutions.

    The Recovery Plan also addresses the roles and responsibility of ICEU Board, management and other personnel, including with respect to development, review and approval, testing and maintenance and liaison with relevant regulatory authorities. The Recovery Plan also includes a description of ICEU, its organizational structure, its applicable regulatory regime and the standards and guidelines that have informed the Recovery Plan. The Recovery Plan is based on the Rules and Procedures of the clearing house as they are in effect, and does not itself change the rights and obligations of the clearing house or its Clearing Members thereunder.

    Critical Services and Functions

    As noted above, ICEU has determined that both its F&O and CDS product category clearing services, as well as its related treasury and banking services, are critical services. The Recovery Plan sets out the methodology used by the clearing house in assessing the criticality of services for this purpose. ICEU has also identified the front-end business functions and support areas (including IT services) that support these critical services. In particular, the Recovery Plan identifies the particular IT systems and services used by ICEU in providing its clearing services (including trade management systems, collateral management systems, risk systems and delivery systems). The Recovery Plan notes the locations from which these services are provided and, in cases where the services are provided by an affiliate or other third party, identifies that party. The Recovery Plan also identifies other key service providers on which ICEU relies, including custodians, concentration banks, other approved payment banks, investment managers and delivery services providers. The Recovery Plan considers the key services provided by ICE affiliates in support of the ICEU clearing activities, including information technology and risk management services.

    Stress Scenarios

    The Recovery Plan analyzes different stress scenarios that may affect ICEU's ability to continue to provide its critical services. The two relevant categories of stress scenarios are default losses and non-default losses. Default losses for this purpose are losses suffered by ICEU as a result of the default of one or more Clearing Member(s). Non-default losses are those suffered by ICEU from identified general business and operational risk events, investment losses, system outages or world-wide or regional political or macroeconomic events. In both categories, ICEU also considers losses resulting from liquidity risks and from the risk of contagion. ICEU uses a risk-based approach to scenario analysis, consisting of different impact categories and severity levels. Specifically, ICEU looks at impacts in five areas: Financial and operational impacts (affecting ICEU's own finances), Clearing Members and their customers (affecting their financial viability), other group infrastructure (affecting the efficiency or effectiveness of other related ICE entities (including exchanges cleared by ICEU), legal and regulatory considerations and macroeconomic (affecting market operations and market stability).

    In terms of impact severity, ICEU assesses scenarios in categories of low, moderate, high, very high and severe. In the context of a default loss, a low severity impact would include a loss contained to the financial resources of the defaulting Clearing Member. By contrast, an event with a severe impact level would be expected to exhaust the funded resources of the clearing house (including ICEU's contribution and the Guaranty Fund contributions of non-defaulting Clearing Members). Other intermediate severity levels will involve corresponding levels of resource consumption and impact on the clearing house. For non-default losses, a low severity is generally defined as a loss of less than 25% of capital resources or a loss having no direct impact on Clearing Members. By contrast, a severe non-default loss would be one in excess of 75% of capital resources are used, or one that otherwise involves a severe degradation of operations. The Recovery Plan contemplates that the range of responses to a loss scenario, including the potential Recovery Options used, will depend on the severity level (with low severity loss events involving limited or no use of Recovery Options, and severe loss scenarios requiring use of all of the available Recovery Options). The Recovery Plan also contemplates different levels of coordination with other CCPs, market participants, regulators and others depending on the severity of the event.

    Recovery Options

    The Recovery Plan sets out the likely Recovery Options that ICEU may implement depending upon the severity of the impact of the scenario, as discussed above. The Recovery Options are based on the rights and obligations of the clearing house under the Rules, Procedures, Risk Management Framework, Default Management Framework, Liquidity Risk Management Framework and other relevant policies and procedures.

    The Recovery Plan considers a non-exhaustive list of available Recovery Options in terms of a number of factors, including the speed with which each option can be implemented, the impact on the clearing house, the impact on Clearing Members and their customers, and the effect on other market infrastructure. The Recovery Plan analyzes loss impact and the use of Recovery Tools separately for F&O defaults, CDS defaults and non-default losses. In general, in the case of default losses, relevant Recovery Options include, consistent with the Rules, powers of assessment, use of a default auction in accordance with auction procedures to fully unwind the defaulter's portfolio (for F&O contracts), forced allocation, to the extent the defaulter's positions cannot otherwise be unwound (for CDS contracts), variation margin gains haircutting (for F&O contracts), porting of client positions and clearing service termination (for F&O contracts).5 In terms of non-default losses, Recovery Options include emergency liquidity facilities, investment loss allocation to Clearing Members to the extent permitted by the Rules and service closure. The Plan contains greater detail regarding how each tool assists with the recovery process. Consistent with the Default Management Framework, the Recovery Plan is intended to be flexible and provide a structure and guidance to management. It is not designed to be prescriptive and it recognizes that the actions to be taken by the clearing house may vary depending on the prevailing circumstances which lead to the default rules being implemented. The Recovery Plan also examines the reliability, timeliness and legal basis of different Recovery Options.

    5 ICEU notes that it is preparing to propose certain amendments to its Rules relating to Recovery Options with respect to CDS contracts, to provide for auctions and variation margin gains haircutting and to eliminate forced allocation, among other changes.

    Recovery Option Application

    The Recovery Plan outlines the situations (and sequence) in which each of the Recovery Options is likely to be used, recognizing that the clearing house has discretion as to the particular actions to take in a default or non-default loss scenario. In general, use of Recovery Options is expected in extreme circumstances where losses exceed pre-funded resources of the clearing house. The Recovery Plan specifies the expected bases for using Recovery Options, such as powers of assessment and variation margin gains haircutting. It further specifies the decision-making process for the use of such options, separately for default and non-default loss scenarios. These arrangements generally specify a particular scenario in which a Recovery Option may be used, along with the key decision-makers involved. In most cases, under the Rules and the default management frameworks, the decision will be made by the ICEU president and managing director pursuant to the authority delegated by the Board, for both default and non-default loss events. In the case of default events, such actions would be taken having regard to the advice of the default management committee. In practice, the president, where appropriate and time permitting, would be expected to consult with the Board or with individual Board members before taking significant actions. The president may also call an emergency Board meeting or make Board members aware of the current position. The president will report decisions to the Board at the next formal Board meeting. If the President is absent, the Chief Operating Officer will act in his stead.

    The Recovery Plan recognizes the importance of clear communications and contemplates that use of Recovery Options would be expected to be implemented through close discussions with the ICEU Board, ICEU Board Risk Committee, Clearing Members, regulators, shareholders and other stakeholders. The Recovery Plan recognizes the risk that ICEU's actions could cause contagion and envisages communication with regulators and other financial market infrastructures to mitigate such effects.

    The Recovery Plan also sets out a series of early warning indicators and tools intended to notify ICEU management that use of Recovery Options may be required, and where possible, avoid the need for such actions. These include liquidity forecasting and monitoring, use of a conservative approach to counterparty credit analyses and establishment of margin and Guaranty Fund requirements, use of comprehensives risk metrics to monitor Clearing Member financial performance, back-testing and stress testing, and other assessments. The clearing house also retains the mechanisms and resources to take prompt decisions, and allow an immediate response to an emerging situation. The Recovery Plan sets out detailed lists of potential early warning indications of a potential loss scenario, such as repeated non-compliance by a Clearing Member with membership or other requirements, actions taken by regulators or other governmental authorities with respect to a Clearing Member, certain quantitative factors, restructuring and similar events. The Recovery Plan outlines particular means of monitoring for potential loss scenarios following such indications.

    Limitations of the Recovery Plan and Related Monitoring

    The Recovery Plan has set out arrangements for identifying and responding to structural weaknesses in governance and risk management that may be identified in a default event or non-default event. ICEU's tools to address such potential weaknesses include: Default tests, operational risk measures (including for business continuity and disaster recovery purposes), an operational oversight committee, internal audit and consultation with external legal counsel.

    The Recovery Plan also notes certain potential limitations of the Recovery Plan, including the risk of potential legal uncertainty (such as a challenge by Clearing Members or other market participants to the use of Recovery Options, notwithstanding the protections available to ICEU under applicable law and the legal diligence conducted by the clearing house with respect to its Rules and policies and procedures). The Recovery Plan also identifies risks of reliance on third party market infrastructures, and notes that the risk of such infrastructure being unavailable is contemplated in stress scenarios. The Recovery Plan also notes ICEU's reliance on the continued support of Intercontinental Exchange, Inc., including as to technology, replenishment of capital resources and business continuity and disaster recovery.

    Governance

    The overall accountability for the Recovery Plan lies with the ICEU President. The Recovery Plan was prepared with the active involvement of the management of ICEU. The Recovery Plan is reviewed and approved by the ICEU Board. The Head of Regulation is responsible for facilitating the overall production and implementation of the Recovery Plan as well as its maintenance. The ICEU Board Audit Committee, Chief Risk Officer, Chief Operating Officer and Executive Risk Committee also have roles in the implementation of the Recovery Plan.

    Second line functions are responsible for ensuring that the Recovery Plan remains up-to-date and reviewed in accordance with internal review and governance control arrangements. On an annual basis, the owner will revise the Recovery Plan and present the revised version to the ICEU Board. Material changes to the Recovery Plan must be reviewed by ICEU management and be subject to governance control. Minor changes can be incorporated as part of the routine review process.

    As part of governance control, the Recovery Plan is subject to annual review by the ICEU Board Audit Committee. Recommendations and discussions by the ICEU Board Audit Committee are recorded and submitted to the Board in a timely manner. The scenarios and actions that support the Recovery Plan are subject to ICEU Board approval annually. Ad hoc reviews may be commissioned if the business materially changes, for example upon the introduction of a new service. Material changes to the Recovery Plan or the scenarios, including those brought about by market events, are subject to ICEU Board approval, following their review and discussion by the ICEU Board Audit Committee. Deviations from the Recovery Plan must be reported to the ICEU Board. Elements of the Recovery Plan are tested as part of normal operations and risk management procedures.

    (b) Statutory Basis

    ICEU believes that the proposed amendments are consistent with the requirements of Section 17A of the Act 6 and the regulations thereunder applicable to it, including the standards under Rule 17Ad-22.7

    6 15 U.S.C. 78q-1.

    7 17 CFR 240.17Ad-22.

    Section 17A(b)(3)(F) of the Act 8 requires, among other things, that the rules of a clearing agency be designed to promote the prompt and accurate clearance and settlement of securities transactions and, to the extent applicable, derivative agreements, contracts, and transactions, the safeguarding of securities and funds in the custody or control of the clearing agency or for which it is responsible, and the protection of investors and the public interest. In addition, Rule 17Ad-22(e)(3)(ii) 9 requires that each covered clearing agency shall establish, implement, maintain and enforce written policies and procedures reasonably designed to, as applicable, maintain a sound risk management framework for comprehensively managing legal, credit, liquidity, operational, general business, investment, custody, and other risks that arise in or are borne by the covered clearing agency, which includes plans for the recovery and orderly wind-down of the covered clearing agency necessitated by credit losses, liquidity shortfalls, losses from general business risk, or any other losses.

    8 15 U.S.C. 78q-1(b)(3)(F).

    9 17 CFR 240.17Ad-22(e)(3)(ii).

    The Recovery Plan is designed to meet the requirements of Rule 17Ad-22(e)(3)(ii), and is further consistent with the requirements of the Act. The Recovery Plan sets out ICEU's plan for recovering from severe loss events, including from credit losses resulting from Clearing Member default, liquidity shortfalls, losses from general business risk, and other types of losses. The Recovery Plan outlines different loss scenarios of these types that ICEU considers as part of its planning process. The Recovery Plan further builds on the provisions of the Rules, and other risk management frameworks, to set out the different Recovery Options that the clearing house has available to it to address loss scenarios, and restore or maintain normal clearing operations. The Recovery Plan outlines triggers for the use of Recovery Tools, as well as the governance process around the use of Recovery Options. The Recovery Plan also provides greater transparency to market participants, including Clearing Members and their customers, about the expected sequence and scope of recovery actions that ICEU may take in a loss scenario. In ICEU's view, the Recovery Plan thus meets the requirements of Rule 17Ad-22(e)(3)(ii). Furthermore, ICEU views the Recovery Plan as a key aspect of its general risk management framework, which furthers its ability to maintain the prompt and accurate clearance and settlement of transactions, including in severe loss scenarios, and thereby promote the protection of investors and the public interest, within the meaning of Section 17A(b)(3)(F) of the Act.

    ICEU further notes the requirement in Rule 17Ad-22(e)(15) 10 to hold sufficient liquid net assets funded by equity to cover potential general business losses so that the covered clearing agency can continue operations and services as a going concern if those losses materialize, including by (i) determining the amount of liquid net assets funded by equity based upon its general business risk profile and the length of time required to achieve a recovery or orderly wind-down, as appropriate, of its critical operations and services if such action is taken, and (ii) holding liquid net assets funded by equity equal to the greater of either (x) six months of the covered clearing agency's current operating expenses, or (y) the amount determined by the board of directors to be sufficient to ensure a recovery or orderly wind-down of critical operations and services of the covered clearing agency, as contemplated by the recovery and wind-down plans established under Rule 17Ad-22(e)(3)(ii).

    10 17 CFR 240.17Ad-22(e)(15).

    ICEU has determined that it holds equity capital at least sufficient to cover the costs of a recovery of its critical clearing services under the Recovery Plan, consistent with the requirements of Rule 17Ad-22(e)(15).11

    11 17 CFR 240.17Ad-22(e)(15).

    (B) Clearing Agency's Statement on Burden on Competition

    ICEU does not believe the proposed Recovery Plan would have any impact, or impose any burden, on competition not necessary or appropriate in furtherance of the purposes of the Act. The Recovery Plan does not itself change the rights or obligations of the clearing house or Clearing Members, and reflects the Recovery Options set out in existing Rules and risk management policies. The Recovery Plan has been designed to meet specific regulatory requirements concerning recovery planning, and is applicable to all clearing activities. ICEU does not believe the amendments will impact competition among Clearing Members or other market participants, or affect the ability of market participants to access clearing generally. While implementation of the Recovery Plan, and in particular use of the Recovery Plan in a severe loss scenario, would likely impose costs on Clearing Members or other market participants, such costs are consistent with the existing Rules, and are, in ICEU's view, appropriate in light of the goals of recovery and maintenance of critical clearing service in accordance with applicable regulations.

    (C) Clearing Agency's Statement on Comments on the Proposed Rule Change Received From Members, Participants or Others

    Written comments relating to the proposed amendments have not been solicited or received by ICE Clear Europe. ICE Clear Europe will notify the Commission of any comments received with respect to the proposed rule change.

    III. Date of Effectiveness of the Proposed Rule Change, Security-Based Swap Submission and Advance Notice 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.

    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 proposed rule change, security-based swap submission or advance notice 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-2017-016 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-ICEEU-2017-016. 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 website (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all written statements with respect to the proposed rule change, security-based swap submission or advance notice that are filed with the Commission, and all written communications relating to the proposed rule change, security-based swap submission or advance notice between the Commission and any person, other than those that may be withheld from the public in accordance with the provisions of 5 U.S.C. 552, will be available for website viewing and printing in the Commission's Public Reference Section, 100 F Street NE, Washington, DC 20549, on official business days between the hours of 10:00 a.m. and 3:00 p.m. Copies of such filings will also be available for inspection and copying at the principal office of ICE Clear Europe and on ICE Clear Europe's website 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-2017-016 and should be submitted on or before February 9, 2018].

    For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.12

    12 17 CFR 200.30-3(a)(12).

    Eduardo A. Aleman, Assistant Secretary.
    [FR Doc. 2018-00853 Filed 1-18-18; 8:45 am] BILLING CODE 8011-01-P
    SECURITIES AND EXCHANGE COMMISSION [Release No. 34-82493; File No. SR-NASDAQ-2018-001] Self-Regulatory Organizations; The Nasdaq Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend Transaction Credits at Rule 7018(a) January 12, 2018.

    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 January 2, 2018, The Nasdaq Stock Market LLC (“Nasdaq” or “Exchange”) filed with the Securities and Exchange Commission (“Commission”) the proposed rule change as described in Items I, II, and III below, which Items have been prepared by the Exchange. The Commission is publishing this notice to solicit comments on the proposed rule change from interested persons.

    1 15 U.S.C. 78s(b)(1).

    2 17 CFR 240.19b-4.

    I. Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change

    The Exchange proposes to a proposal to amend transaction credits at Rule 7018(a) to: (i) Decrease a $0.00295 per share executed credit provided under paragraphs (1), (2) and (3) of the Rule for displayed quotes/orders (other than Supplemental Orders or Designated Retail Orders) that provide liquidity to $0.0029; (ii) include Limit-on-Close Orders entered between 3:50 p.m. ET and immediately prior to 3:55 p.m. ET for purposes of calculating shares of liquidity to qualify for a credit tier provided under paragraphs (1), (2) and (3) of the Rule for displayed quotes/orders (other than Supplemental Orders or Designated Retail Orders) that provide liquidity; (iii) increase the level of Consolidated Volume required to receive a $0.0029 per share executed credit provided under paragraphs (1), (2) and (3) of the Rule for displayed quotes/orders (other than Supplemental Orders or Designated Retail Orders) that provide liquidity; and (iv) delete a $0.0029 per share executed credit provided under paragraphs (1), (2) and (3) of the Rule for displayed quotes/orders (other than Supplemental Orders or Designated Retail Orders) that provide liquidity.

    The text of the proposed rule change is available on the Exchange's website at http://nasdaq.cchwallstreet.com/, at the principal office of the Exchange, and at the Commission's Public Reference Room.

    II. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.

    A. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change 1. Purpose

    The purpose of the proposed rule change is to amend Rule 7018(a) (the “Rule”): (i) Decrease a $0.00295 per share executed credit provided under paragraphs (1), (2) and (3) of the Rule for displayed quotes/orders (other than Supplemental Orders or Designated Retail Orders) that provide liquidity to $0.0029; (ii) include Limit-on-Close Orders entered between 3:50 p.m. ET and immediately prior to 3:55 p.m. ET for purposes of calculating shares of liquidity to qualify for a credit tier provided under paragraphs (1), (2) and (3) of the Rule for displayed quotes/orders (other than Supplemental Orders or Designated Retail Orders) that provide liquidity; (iii) increase the level of Consolidated Vo