Federal Register Vol. 83, No.202,

Federal Register Volume 83, Issue 202 (October 18, 2018)

Page Range52751-52941
FR Document

83_FR_202
Current View
Page and SubjectPDF
83 FR 52941 - Continuation of the National Emergency With Respect to Significant Narcotics Traffickers Centered in ColombiaPDF
83 FR 52937 - Blind Americans Equality Day, 2018PDF
83 FR 52935 - National School Lunch Week, 2018PDF
83 FR 52933 - Minority Enterprise Development Week, 2018PDF
83 FR 52832 - Sunshine Act MeetingPDF
83 FR 52850 - Sunshine Act; Notice of Matters To Be Deleted From the Agenda of a Previously Announced Agency MeetingPDF
83 FR 52849 - Government in the Sunshine Act Meeting NoticePDF
83 FR 52841 - Posting of the National Security Presidential Memorandum 14, “Support for National Biodefense”PDF
83 FR 52849 - Notice of Open MeetingPDF
83 FR 52868 - Wisconsin Central Ltd.-Discontinuance of Service Exemption-in Ashland and Price Counties, Wis.PDF
83 FR 52833 - Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding CompanyPDF
83 FR 52851 - Submission for OMB Review, Comment Request, Proposed Collection: IMLS Accelerating Promising Practices for Small Libraries (APP) Notice of Funding OpportunityPDF
83 FR 52770 - Special Local Regulation; San Diego Bay, San Diego, CAPDF
83 FR 52815 - Open Meeting of the Information Security and Privacy Advisory BoardPDF
83 FR 52822 - DOE/NSF Nuclear Science Advisory CommitteePDF
83 FR 52849 - The Performance Review BoardPDF
83 FR 52767 - Government Securities Act Regulations: Large Position Reporting RulesPDF
83 FR 52768 - Certifications and Exemptions Under the International Regulations for Preventing Collisions at Sea, 1972PDF
83 FR 52851 - 30-Day Notice for the “Our Town Program Implementation Study” Proposed Collection; Comment RequestPDF
83 FR 52824 - Blackstone Hydro, Inc.; Notice of Application Tendered for Filing With the Commission and Soliciting Additional Study Requests and Establishing Procedural Schedule for Relicensing and a Deadline for Submission of Final AmendmentsPDF
83 FR 52828 - Rio Grande LNG, LLC, Rio Bravo Pipeline Company, LLC; Notice of Availability of the Draft Environmental Impact Statement for the Proposed Rio Grande LNG ProjectPDF
83 FR 52816 - Supervisory Highlights: Summer 2018PDF
83 FR 52845 - Center for Scientific Review; Notice of Closed MeetingsPDF
83 FR 52847 - Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of MeetingPDF
83 FR 52847 - Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed MeetingPDF
83 FR 52843 - Government-Owned Inventions; Availability for Licensing; CorrectionPDF
83 FR 52834 - Partnership Opportunity To List in a Public Database (PPE-Info) Appropriate Personnel Protective Equipment Products That Protect Workers Against Fentanyl ExposurePDF
83 FR 52804 - Certain Uncoated Paper From Brazil: Final Results of Antidumping Duty Administrative Review; 2015-2017PDF
83 FR 52809 - Drawn Stainless Steel Sinks From the People's Republic of China: Partial Rescission of Antidumping Duty Administrative Review; 2017-2018PDF
83 FR 52775 - Endangered and Threatened Wildlife and Plants; Removing Deseret Milkvetch (Astragalus desereticus) From the Federal List of Endangered and Threatened PlantsPDF
83 FR 52826 - GRP Madison, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 AuthorizationPDF
83 FR 52829 - GRP Franklin, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 AuthorizationPDF
83 FR 52827 - North Rosamond Solar, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 AuthorizationPDF
83 FR 52832 - Combined Notice of Filings #2PDF
83 FR 52826 - Combined Notice of Filings #1PDF
83 FR 52830 - Combined Notice of FilingsPDF
83 FR 52824 - Keystone Power Pass-Through Holders LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 AuthorizationPDF
83 FR 52827 - Conemaugh Power Pass-Through Holders LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 AuthorizationPDF
83 FR 52830 - Combined Notice of Filings #1PDF
83 FR 52840 - Agency Information Collection Activities: Proposed Collection: Public Comment Request: Information Collection Request Title: Bureau of Health Workforce Performance Data Collection, OMB No. 0915-0061-RevisionPDF
83 FR 52872 - Hours of Service of Drivers: Wolfe House Movers, LLC and Wolfe House Movers of Indiana, LLC; Application for ExemptionPDF
83 FR 52873 - Hours of Service of Drivers: Transco, Inc.; Application for ExemptionPDF
83 FR 52822 - Distribution of Residual Citronelle Settlement Agreement FundsPDF
83 FR 52869 - Hours of Service of Drivers: Rota-Mill, Inc.; Application for ExemptionPDF
83 FR 52875 - Hours of Service of Drivers: RJR Transportation, Inc.; Application for ExemptionPDF
83 FR 52870 - Hours of Service of Drivers: Application for Exemption; Fiat Chrysler Automobiles (FCA)PDF
83 FR 52835 - Proposed Information Collection Activity; Comment RequestPDF
83 FR 52837 - Determination of Regulatory Review Period for Purposes of Patent Extension; OCREVUSPDF
83 FR 52789 - Medicare and Medicaid Programs; Regulation To Require Drug Pricing TransparencyPDF
83 FR 52835 - Content of Premarket Submissions for Management of Cybersecurity in Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; AvailabilityPDF
83 FR 52839 - Determination of Regulatory Review Period for Purposes of Patent Extension; AFSTYLAPDF
83 FR 52868 - Presidential Declaration Amendment of a Major Disaster for Public Assistance Only for the State of CaliforniaPDF
83 FR 52868 - Presidential Declaration Amendment of a Major Disaster for the State of North CarolinaPDF
83 FR 52848 - Collection of Information Under Review by Office of Management and Budget; OMB Control Number: 1625-0014PDF
83 FR 52801 - MeetingsPDF
83 FR 52800 - U.S. Codex Program: FY2019-2023 Strategic PlanPDF
83 FR 52760 - Fisheries of the Exclusive Economic Zone off Alaska; Pacific Halibut and Sablefish Individual Fishing Quota Program; Community Development Quota Program; Modifications to Recordkeeping and Reporting RequirementsPDF
83 FR 52801 - Notice of Petitions by Firms for Determination of Eligibility To Apply for Trade Adjustment AssistancePDF
83 FR 52865 - Self-Regulatory Organizations; Miami International Securities Exchange, LLC; Order Granting Approval of a Proposed Rule Change To List and Trade Options on the SPIKESTMPDF
83 FR 52854 - Self-Regulatory Organizations; New York Stock Exchange LLC; Notice of Filing of Proposed Rule Change To Amend the Listed Company Manual for Acquisition Companies To Reduce the Continued Listing Standards for Public Holders From 300 to 100 and To Enable the Exchange To Exercise Discretion To Allow Acquisition Companies a Reasonable Time Period Following a Business Combination To Demonstrate Compliance With the Applicable Quantitative Listing StandardsPDF
83 FR 52857 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a Proposed Rule Change To Amend the Arbitrator Payment Rule To Pay Each Arbitrator a $200 Honorarium To Decide Without a Hearing Session a Contested Subpoena Request or a Contested Order for Production or AppearancePDF
83 FR 52844 - Center for Scientific Review; Notice of Closed MeetingsPDF
83 FR 52847 - National Center for Complementary & Integrative Health; Notice of MeetingPDF
83 FR 52848 - National Center for Complementary & Integrative Health; Notice of MeetingPDF
83 FR 52852 - Privacy Act of 1974; System of RecordsPDF
83 FR 52860 - Audax Credit BDC Inc., et al.; Notice of ApplicationPDF
83 FR 52833 - Board MeetingPDF
83 FR 52802 - Corporation for Travel Promotion Board of DirectorsPDF
83 FR 52833 - Formations of, Acquisitions by, and Mergers of Bank Holding CompaniesPDF
83 FR 52850 - Notice of Intent To Grant Partially Exclusive LicensePDF
83 FR 52849 - Membership of the Merit Systems Protection Board's Performance Review BoardPDF
83 FR 52787 - Receipt of Several Pesticide Petitions Filed for Residues of Pesticide Chemicals in or on Various CommoditiesPDF
83 FR 52811 - Aluminum Wire and Cable From the People's Republic of China: Initiation of Less-Than-Fair-Value InvestigationPDF
83 FR 52805 - Aluminum Wire and Cable From the People's Republic of China: Initiation of Countervailing Duty InvestigationPDF
83 FR 52772 - Approval and Promulgation of Air Quality Implementation Plans; West Virginia; Update to Materials Incorporated by ReferencePDF
83 FR 52803 - Large Residential Washers From the Republic of Korea: Final Results of the First Five-Year Sunset Review of the Antidumping Duty OrderPDF
83 FR 52808 - Quarterly Update to Annual Listing of Foreign Government Subsidies on Articles of Cheese Subject to an In-Quota Rate of DutyPDF
83 FR 52810 - Certain Uncoated Paper From Portugal: Final Results of Antidumping Duty Administrative Review; 2015-2017PDF
83 FR 52902 - Registration and Compliance Requirements for Commodity Pool Operators and Commodity Trading AdvisorsPDF
83 FR 52751 - Airworthiness Directives; Bombardier, Inc., AirplanesPDF
83 FR 52754 - Airworthiness Directives; Bombardier, Inc., AirplanesPDF
83 FR 52756 - Airworthiness Directives; Bombardier, Inc., AirplanesPDF
83 FR 52878 - Hazardous Materials: Notification of the Pilot-in-Command and Response to Air Related Petitions for RulemakingPDF

Issue

83 202 Thursday, October 18, 2018 Contents Agriculture Agriculture Department See

The U.S. Codex Office

Architectural Architectural and Transportation Barriers Compliance Board NOTICES Meetings: Access Board, 52801 2018-22689 Consumer Financial Protection Bureau of Consumer Financial Protection NOTICES Supervisory Highlights: Summer 2018, 52816-52822 2018-22726 Centers Disease Centers for Disease Control and Prevention NOTICES Partnership Opportunity to List in a Public Database Appropriate Personnel Protective Equipment Products That Protect Workers against Fentanyl Exposure, 52834 2018-22721 Centers Medicare Centers for Medicare & Medicaid Services PROPOSED RULES Medicare and Medicaid Programs: Drug Pricing Transparency, 52789-52799 2018-22698 Children Children and Families Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals:, 52835 2018-22700 Coast Guard Coast Guard RULES Special Local Regulations: San Diego Bay, San Diego, CA, 52770-52772 2018-22736 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: OMB Control Number: 1625-0014, 52848-52849 2018-22690 Commerce Commerce Department See

Economic Development Administration

See

International Trade Administration

See

National Institute of Standards and Technology

See

National Oceanic and Atmospheric Administration

Commodity Futures Commodity Futures Trading Commission PROPOSED RULES Registration and Compliance Requirements for Commodity Pool Operators and Commodity Trading Advisors, 52902-52929 2018-22324 Defense Department Defense Department See

Navy Department

Economic Development Economic Development Administration NOTICES Trade Adjustment Assistance Eligibility; Petitions, 52801-52802 2018-22684 Energy Department Energy Department See

Federal Energy Regulatory Commission

NOTICES Distribution of Residual Citronelle Settlement Agreement Funds, 52822-52824 2018-22705 Meetings: DOE/NSF Nuclear Science Advisory Committee, 52822 2018-22734
Environmental Protection Environmental Protection Agency RULES Air Quality State Implementation Plans; Approvals and Promulgations: West Virginia; Update to Materials Incorporated by Reference, 52772-52775 2018-22653 PROPOSED RULES Pesticide Petitions: Residues of Pesticide Chemicals in or on Various Commodities, 52787-52789 2018-22659 Federal Aviation Federal Aviation Administration RULES Airworthiness Directives: Bombardier, Inc. Airplanes, 52751-52760 2018-22137 2018-22148 2018-22150 Federal Election Federal Election Commission NOTICES Meetings; Sunshine Act, 52832-52833 2018-22887 Federal Energy Federal Energy Regulatory Commission NOTICES Combined Filings, 52826-52827, 52830-52832 2018-22709 2018-22712 2018-22713 2018-22714 Environmental Impact Statements; Availability, etc.: Rio Grande LNG, LLC, Rio Bravo Pipeline Co., LLC; Rio Grande LNG Project, 52828-52829 2018-22727 Initial Market-Based Rate Filings Including Requests for Blanket Section 204 Authorizations: Conemaugh Power Pass-Through Holders LLC, 52827 2018-22710 GRP Franklin, LLC, 52829-52830 2018-22716 GRP Madison, LLC, 52826 2018-22717 Keystone Power Pass-Through Holders, LLC, 52824 2018-22711 North Rosamond Solar, LLC, 52827-52828 2018-22715 License Applications: Blackstone Hydro, Inc., 52824-52826 2018-22728 Federal Motor Federal Motor Carrier Safety Administration NOTICES Hours of Service of Drivers; Exemption Applications: Fiat Chrysler Automobiles, 52870-52872 2018-22701 RJR Transportation, Inc., 52875-52876 2018-22702 Rota-Mill, Inc., 52869-52870 2018-22703 Transco, Inc., 52873-52875 2018-22706 Wolfe House Movers, LLC and Wolfe House Movers of Indiana, LLC, 52872-52873 2018-22707 Federal Reserve Federal Reserve System NOTICES Change in Bank Control: Acquisitions of Shares of a Bank or Bank Holding Company, 52833 2018-22671 2018-22738 Formations of, Acquisitions by, and Mergers of Bank Holding Companies, 52833 2018-22670 Federal Retirement Federal Retirement Thrift Investment Board NOTICES Meetings: Board Meeting, 52833-52834 2018-22675 Fish Fish and Wildlife Service RULES Endangered and Threatened Species: Removing Deseret Milkvetch (Astragalus desereticus) from the Federal List of Endangered and Threatened Plants, 52775-52786 2018-22718 Food and Drug Food and Drug Administration NOTICES Determinations of Regulatory Review Period for Purposes of Patent Extension: AFSTYLA, 52839-52840 2018-22696 OCREVUS, 52837-52839 2018-22699 Guidance: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, 52835-52837 2018-22697 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 Support for National Biodefense, 52841-52843 2018-22742
Health Resources Health Resources and Services Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Bureau of Health Workforce Performance Data Collection, 52840-52841 2018-22708 Homeland Homeland Security Department See

Coast Guard

Housing Housing and Urban Development Department NOTICES Performance Review Board, 52849 2018-22733 Institute of Museum and Library Services Institute of Museum and Library Services NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Accelerating Promising Practices for Small Libraries Notice of Funding Opportunity, 52851 2018-22737 Interior Interior Department See

Fish and Wildlife Service

International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Aluminum Wire and Cable from the People's Republic of China, 52805-52808 2018-22655 Certain Uncoated Paper from Brazil, 52804-52805 2018-22720 Certain Uncoated Paper from Portugal, 52810-52811 2018-22575 Drawn Stainless Steel Sinks from the People's Republic of China, 52809-52810 2018-22719 Large Residential Washers from the Republic of Korea, 52803 2018-22635 Initiation of Less-Than-Fair-Value Investigations: Aluminum Wire and Cable from the People's Republic of China, 52811-52815 2018-22656 Quarterly Update to Annual Listing of Foreign Government Subsidies on Articles of Cheese Subject to an In-Quota Rate of Duty, 52808-52809 2018-22613 Requests for Nominations: Corporation for Travel Promotion Board of Directors, 52802-52803 2018-22673 International Trade Com International Trade Commission NOTICES Meetings; Sunshine Act, 52849 2018-22798 Merit Merit Systems Protection Board NOTICES Performance Review Board Membership, 52849 2018-22668 Millenium Millennium Challenge Corporation NOTICES Meetings: Advisory Council, 52849-52850 2018-22740 NASA National Aeronautics and Space Administration NOTICES Partially Exclusive Licenses; Approvals, 52850 2018-22669 National Credit National Credit Union Administration NOTICES Meetings; Sunshine Act, 52850 2018-22847 National Endowment for the Arts National Endowment for the Arts NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Our Town Program Implementation Study, 52851-52852 2018-22729 National Foundation National Foundation on the Arts and the Humanities See

Institute of Museum and Library Services

See

National Endowment for the Arts

National Institute National Institute of Standards and Technology NOTICES Meetings: Information Security and Privacy Advisory Board, 52815-52816 2018-22735 National Institute National Institutes of Health NOTICES Government-Owned Inventions; Availability for Licensing; Correction, 52843-52844 2018-22722 Meetings: Center for Scientific Review, 52844-52847 2018-22680 2018-22725 Eunice Kennedy Shriver National Institute of Child Health and Human Development, 52847 2018-22723 2018-22724 National Center for Complementary and Integrative Health, 52847-52848 2018-22678 2018-22679 National Oceanic National Oceanic and Atmospheric Administration RULES Fisheries of the Exclusive Economic Zone off Alaska: Pacific Halibut and Sablefish Individual Fishing Quota Program; Community Development Quota Program; Modifications to Recordkeeping and Reporting Requirements, 52760-52767 2018-22687 Navy Navy Department RULES Certifications and Exemptions Under the International Regulations for Preventing Collisions at Sea, 1972, 52768-52770 2018-22730 Occupational Safety Health Rev Occupational Safety and Health Review Commission NOTICES Privacy Act; Systems of Records, 52852-52854 2018-22677 Pipeline Pipeline and Hazardous Materials Safety Administration RULES Hazardous Materials: Pilot-in-Command and Response to Air Related Petitions for Rulemaking, 52878-52900 2018-22114 Presidential Documents Presidential Documents PROCLAMATIONS Special Observances: Blind Americans Equality Day (Proc. 9807), 52937-52938 2018-22938 Minority Enterprise Development Week (Proc. 9805), 52931-52934 2018-22936 National School Lunch Week (Proc. 9806), 52935-52936 2018-22937 ADMINISTRATIVE ORDERS Colombia; Continuation of National Emergency With Respect to Narcotics Traffickers (Notice of October 17, 2018), 52939-52941 2018-22962 Securities Securities and Exchange Commission NOTICES Applications: Audax Credit BDC Inc., et al., 52860-52865 2018-22676 Self-Regulatory Organizations; Proposed Rule Changes: Financial Industry Regulatory Authority, Inc., 52857-52860 2018-22681 Miami International Securities Exchange, LLC, 52865-52868 2018-22683 New York Stock Exchange, LLC, 52854-52857 2018-22682 Small Business Small Business Administration NOTICES Presidential Declaration Amendment of a Major Disaster: California; Public Assistance Only; Amendment 2, 52868 2018-22693 North Carolina, 52868 2018-22691 Surface Transportation Surface Transportation Board NOTICES Discontinuance of Service Exemptions: Wisconsin Central Ltd., Ashland and Price Counties, WI, 52868-52869 2018-22739 Codex The U.S. Codex Office NOTICES U.S. Codex Program: FY2019-2023 Strategic Plan, 52800 2018-22688 Transportation Department Transportation Department See

Federal Aviation Administration

See

Federal Motor Carrier Safety Administration

See

Pipeline and Hazardous Materials Safety Administration

Treasury Treasury Department RULES Government Securities Act Regulations: Large Position Reporting Rules, 52767-52768 2018-22732 Separate Parts In This Issue Part II Transportation Department, Pipeline and Hazardous Materials Safety Administration, 52878-52900 2018-22114 Part III Commodity Futures Trading Commission, 52902-52929 2018-22324 Part IV Presidential Documents, 52931-52938 2018-22938 2018-22936 2018-22937 Part V Presidential Documents, 52939-52941 2018-22962 Reader Aids

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

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83 202 Thursday, October 18, 2018 Rules and Regulations DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2018-0553; Product Identifier 2017-NM-138-AD; Amendment 39-19446; AD 2018-20-12] RIN 2120-AA64 Airworthiness Directives; Bombardier, Inc., Airplanes AGENCY:

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

ACTION:

Final rule.

SUMMARY:

We are adopting a new airworthiness directive (AD) for certain Bombardier, Inc., Model DHC-8-102, -103, and -106 airplanes, Model DHC-8-200 series airplanes, and Model DHC-8-300 series airplanes. This AD was prompted by reports of arcing and smoke emanating from the windshield, caused by loose or damaged windshield heater terminal lugs. This AD requires revising the maintenance or inspection program to incorporate maintenance review board (MRB) tasks for general visual inspections of the windshield moisture seal. This AD also requires re-torqueing the windshield heater terminal lugs, applying a coating to the windshield heater screw heads, doing a chemical cleaning of the wiring and components, doing a visual inspection of the wiring and components, doing an operational test of the pilot's and co-pilot's windshield heating system, and repair if necessary We are issuing this AD to address the unsafe condition on these products.

DATES:

This AD is effective November 23, 2018.

The Director of the Federal Register approved the incorporation by reference of certain publications listed in this AD as of November 23, 2018.

ADDRESSES:

For service information identified in this final rule, contact Bombardier, Inc., Q-Series Technical Help Desk, 123 Garratt Boulevard, Toronto, Ontario M3K 1Y5, Canada; telephone 416-375-4000; fax 416-375-4539; email [email protected]; internet http://www.bombardier.com. You may view this service information at the FAA, Transport Standards Branch, 2200 South 216th St., Des Moines, WA. For information on the availability of this material at the FAA, call 206-231-3195. It is also available on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-0553.

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-2018-0553; or in person at Docket Operations between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this final rule, the regulatory evaluation, any comments received, and other information. The address for Docket Operations (phone: 800-647-5527) is U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT:

John P. DeLuca, Aerospace Engineer, Avionics and Administrative Services Section, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-7369; fax 516-794-5531; email [email protected].gov.

SUPPLEMENTARY INFORMATION:

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain Bombardier, Inc., Model DHC-8-102, -103, and -106 airplanes, Model DHC-8-200 series airplanes, and Model DHC-8-300 series airplanes. The NPRM published in the Federal Register on July 6, 2018 (83 FR 31493). The NPRM was prompted by reports of arcing and smoke emanating from the windshield, caused by loose or damaged windshield heater terminal lugs. The NPRM proposed to require revising the maintenance or inspection program to incorporate MRB tasks for general visual inspections of the windshield moisture seal. The NPRM also proposed to require re-torqueing the windshield heater terminal lugs, applying a coating to the windshield heater screw heads, doing a chemical cleaning of the wiring and components, doing a visual inspection of the wiring and components, doing an operational test of the pilot's and co-pilot's windshield heating system, and repair if necessary.

We are issuing this AD to address loose terminal lugs and terminal lugs damaged due to fluid ingress between the windshields and side window posts, which could lead to burning of the lugs and cracking of the windshields, and could ultimately cause a loss of cabin pressure, resulting in an emergency descent.

Transport Canada Civil Aviation (TCCA), which is the aviation authority for Canada, has issued Canadian AD CF-2017-25, dated July 31, 2017 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Bombardier, Inc., Model DHC-8-102, -103, and -106 airplanes, Model DHC-8-200 series airplanes, and Model DHC-8-300 series airplanes. The MCAI states:

There have been several reports of arcing and smoke emanating from the windshields. Investigation of these incidents revealed that de-icing fluid and water could enter between the windshields and side window posts, leading to possible damage of the windshield heater terminal lugs creating arcing and smoke. In addition, investigation also revealed that the windshield heater terminal lugs tend to loosen over time. Loose terminal lugs could also have a similar effect of arcing and smoke. Both events could lead to burning of the lugs and, due to the excessive heat, cracking of the windshields. If not corrected, these conditions could cause a loss of cabin pressure resulting in an emergency descent.

You may examine the MCAI in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-0553. Comments

We gave the public the opportunity to participate in developing this final rule. We have considered the comment received. The Air Line Pilots Association, International (ALPA) indicated its support for the NPRM.

Conclusion

We reviewed the relevant data, considered the comment received, and determined that air safety and the public interest require adopting this final rule as proposed, except for minor editorial changes. We have determined that these minor changes:

• Are consistent with the intent that was proposed in the NPRM for addressing the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM.

Related Service Information Under 1 CFR Part 51

Bombardier has issued Service Bulletin 8-30-41, Revision A, dated March 24, 2017. This service information describes procedures for re-torqueing the windshield heater terminal lugs and applying Humiseal coating to the screw heads of the windshield heater, doing a chemical cleaning and general visual inspection of the wiring and components, and doing an operational test of the windshield heating system.

Bombardier has also issued the following service information, which describes airworthiness limitation tasks for a general visual inspection of the windshield moisture seal. These documents are distinct since they apply to different airplane models.

• de Havilland Inc. Dash 8 Series 100 Maintenance Task Card Task Number 5610/01, “General Visual Inspection of the Windshield Moisture Seal,” dated August 5, 2017.

• de Havilland Inc. Dash 8 Series 200 Maintenance Task Card Task Number 5610/01, “General Visual Inspection of the Windshield Moisture Seal,” dated August 5, 2017.

• de Havilland Inc. Dash 8 Series 300 Maintenance Task Card Task Number 5610/01, “General Visual Inspection of the Windshield Moisture Seal,” dated March 15, 2017.

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

Costs of Compliance

We estimate that this AD affects 63 airplanes of U.S. registry.

We estimate the following costs to comply with this AD:

Estimated Costs for Required Actions * Labor cost Parts cost Cost per
  • product
  • Cost on U.S.
  • operators
  • 3 work-hours × $85 per hour = $255 $0 $255 $16,065 * Table does not include estimated costs for revising the maintenance or inspection program.

    We have determined that revising the maintenance or inspection program takes an average of 90 work-hours per operator, although we recognize that this number may vary from operator to operator. In the past, we have estimated that this action takes 1 work-hour per airplane. Since operators incorporate maintenance or inspection program changes for their affected fleet(s), we have determined that a per-operator estimate is more accurate than a per-airplane estimate. Therefore, we estimate the total cost per operator to be $7,650 (90 work-hours × $85 per work-hour).

    We have received no definitive data that would enable us to provide cost estimates for the on-condition actions specified in this AD.

    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 and associated appliances to the Director of the System Oversight Division.

    Regulatory Findings

    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): 2018-20-12 Bombardier, Inc.: Amendment 39-19446; Docket No. FAA-2018-0553; Product Identifier 2017-NM-138-AD. (a) Effective Date

    This AD is effective November 23, 2018.

    (b) Affected ADs

    None.

    (c) Applicability

    This AD applies to Bombardier, Inc., Model DHC-8-102, -103, -106, -201, -202, -301, -311, and -315 airplanes, certificated in any category, serial numbers 003 through 672 inclusive.

    (d) Subject

    Air Transport Association (ATA) of America Code 30, Ice and rain protection.

    (e) Reason

    This AD was prompted by reports of arcing and smoke emanating from the windshield, caused by loose or damaged windshield heater terminal lugs. We are issuing this AD to address loose terminal lugs and terminal lugs damaged due to fluid ingress between the windshields and side window posts, which could lead to burning of the lugs and cracking of the windshields, and could ultimately cause a loss of cabin pressure, resulting in an emergency descent.

    (f) Compliance

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

    (g) Maintenance or Inspection Program Revision

    Within 30 days after the effective date of this AD, revise the existing maintenance or inspection program, as applicable, to incorporate the applicable task identified in paragraphs (g)(1), (g)(2), and (g)(3) of this AD into the applicable program support manual (PSM) identified in table 1 to paragraph (g) of this AD, which is included in the existing maintenance or inspection program. The initial compliance time for the tasks are within 1,600 flight hours or 12 months, whichever occurs first after the effective date of this AD.

    (1) de Havilland Inc. Dash 8 Series 100 Maintenance Task Card Task Number 5610/01, “General Visual Inspection of the Windshield Moisture Seal,” dated August 5, 2017.

    (2) de Havilland Inc. Dash 8 Series 200 Maintenance Task Card Task Number 5610/01, “General Visual Inspection of the Windshield Moisture Seal,” dated August 5, 2017.

    (3) de Havilland Inc. Dash 8 Series 300 Maintenance Task Card Task Number 5610/01, “General Visual Inspection of the Windshield Moisture Seal,” dated March 15, 2017.

    Table 1 to Paragraph (g) of This AD—PSM to Update Airplane model Maintenance
  • requirements manual
  • (MRM)
  • DHC-8-102, -103, and -106 PSM 1-8-7 DHC-8-201 and -202 PSM 1-82-7 DHC-8-301, -311, and -315 PSM 1-83-7
    (h) No Alternative Actions or Intervals

    After the maintenance or inspection program has been revised as required by paragraph (g) of this AD, no alternative actions (e.g., inspections) or intervals may be used unless the actions or intervals are approved as an alternative method of compliance (AMOC) in accordance with the procedures specified in paragraph (k)(1) of this AD.

    (i) Cleaning, Inspection, Re-Torqueing, Sealant Application, and Operational Test

    Within 8,000 flight hours or 60 months, whichever occurs first after the effective date of this AD: Perform a chemical cleaning of the wiring and components, do a general visual inspection of the wiring and components for signs of cracking, erosion, wear, or other damage, re-torque the windshield heater terminal lugs, apply Humiseal coating to the screw heads of the windshield heater, and do an operational test of the pilot's and co-pilot's windshield heating system, in accordance with the Accomplishment Instructions of Bombardier Service Bulletin 8-30-41, Revision A, dated March 24, 2017. If the operational test fails, before further flight, do corrective actions, repeat the test, and do applicable corrective actions until the operational test is passed. If any cracking, erosion, wear, or other damage is found, before further flight, repair using a method approved by the Manager, New York ACO Branch, FAA; or Transport Canada Civil Aviation (TCCA); or Bombardier, Inc.'s TCCA Design Approval Organization (DAO). If approved by the DAO, the approval must include the DAO-authorized signature.

    (j) Credit for Previous Actions

    This paragraph provides credit for the actions required by paragraph (i) of this AD, if those actions were performed before the effective date of this AD using Bombardier Service Bulletin 8-30-41, dated March 31, 2016.

    (k) Other FAA AD Provisions

    The following provisions also apply to this AD:

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

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

    (l) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information (MCAI) Canadian Airworthiness Directive CF-2017-25, dated July 31, 2017, for related information. This MCAI may be found in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-0553.

    (2) For more information about this AD, contact John P. DeLuca, Aerospace Engineer, Avionics and Administrative Services Section, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-7369; fax 516-794-5531; email [email protected]

    (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) Bombardier Service Bulletin 8-30-41, Revision A, dated March 24, 2017.

    (ii) de Havilland Inc. Dash 8 Series 100 Maintenance Task Card Task Number 5610/01, “General Visual Inspection of the Windshield Moisture Seal,” dated August 5, 2017.

    (iii) de Havilland Inc. Dash 8 Series 200 Maintenance Task Card Task Number 5610/01, “General Visual Inspection of the Windshield Moisture Seal,” dated August 5, 2017.

    (iv) de Havilland Inc. Dash 8 Series 300 Maintenance Task Card Task Number 5610/01, “General Visual Inspection of the Windshield Moisture Seal,” dated March 15, 2017.

    (3) For service information identified in this AD, contact Bombardier, Inc., Q-Series Technical Help Desk, 123 Garratt Boulevard, Toronto, Ontario M3K 1Y5, Canada; telephone 416-375-4000; fax 416-375-4539; email [email protected]; internet http://www.bombardier.com.

    (4) You may view this service information at the FAA, Transport Standards Branch, 2200 South 216th St., Des Moines, WA. For information on the availability of this material at the FAA, call 206-231-3195.

    (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 Des Moines, Washington, on September 20, 2018. John P. Piccola, Acting Director, System Oversight Division, Aircraft Certification Service.
    [FR Doc. 2018-22150 Filed 10-17-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2018-0586; Product Identifier 2017-NM-151-AD; Amendment 39-19445; AD 2018-20-11] RIN 2120-AA64 Airworthiness Directives; Bombardier, Inc., Airplanes AGENCY:

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

    ACTION:

    Final rule.

    SUMMARY:

    We are adopting a new airworthiness directive (AD) for certain Bombardier, Inc., Model DHC-8-300 series airplanes. This AD was prompted by reports indicating that a certain emergency exit door could not be opened during maintenance. This AD requires a detailed inspection of the ball bearings of an emergency exit, replacement of bearings if necessary, application of corrosion inhibiting compound (CIC), and revision of the maintenance or inspection program, as applicable. We are issuing this AD to address the unsafe condition on these products.

    DATES:

    This AD is effective November 23, 2018.

    The Director of the Federal Register approved the incorporation by reference of certain publications listed in this AD as of November 23, 2018.

    ADDRESSES:

    For service information identified in this final rule, contact Bombardier, Inc., Q-Series Technical Help Desk, 123 Garratt Boulevard, Toronto, Ontario M3K 1Y5, Canada; telephone 416-375-4000; fax 416-375-4539; email [email protected]; internet http://www.bombardier.com. You may view this service information at the FAA, Transport Standards Branch, 2200 South 216th St., Des Moines, WA. For information on the availability of this material at the FAA, call 206-231-3195. It is also available on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-0586.

    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-2018-0586; or in person at Docket Operations between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this final rule, the regulatory evaluation, any comments received, and other information. The address for Docket Operations (phone: 800-647-5527) is U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590.

    FOR FURTHER INFORMATION CONTACT:

    Darren Gassetto, Aerospace Engineer, Airframe and Propulsion Section, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-7323; fax 516-794-5531; email [email protected]

    SUPPLEMENTARY INFORMATION:

    Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain Bombardier, Inc., Model DHC-8-300 series airplanes. The NPRM published in the Federal Register on July 6, 2018 (83 FR 31496). The NPRM was prompted by reports indicating that a certain emergency exit door could not be opened during maintenance. The NPRM proposed to require a detailed inspection of the ball bearings of an emergency exit, replacement of bearings if necessary, application of CIC, and revision of the maintenance or inspection program, as applicable.

    We are issuing this AD to address corrosion of the emergency exit door ball bearings, which could result in the inability to open the emergency exit door during an emergency evacuation and consequently impede airplane egress.

    Transport Canada Civil Aviation (TCCA), which is the aviation authority for Canada, has issued Canadian Airworthiness Directive CF-2017-30, dated August 30, 2017 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Bombardier, Inc., Model DHC-8-300 series airplanes. The MCAI states:

    An operator has reported the inability to open the Forward Right Hand Type I emergency exit door with either the internal or external handle during maintenance. Investigation has determined that the handle was found to be jammed due to corroded center and lower shaft ball bearings. Condensation has been found to be the root cause of the Forward Right Hand Type I emergency exit door hardware corrosion. Other Forward Right Hand Type I emergency exit door ball bearings are also susceptible to corrosion. Inability to open the Forward Right Hand Type I emergency exit door during an emergency evacuation may impede aircraft egress.

    This [Canadian] AD mandates the inspection for corrosion and replacement, as required, of all Forward Right Hand Type I emergency exit door ball bearings, and the application of corrosion inhibiting compound (CIC), to ensure that the Forward Right Hand Type I emergency exit door can be opened when required.

    You may examine the MCAI in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-0586.

    Comments

    We gave the public the opportunity to participate in developing this final rule. We have considered the comment received. The Air Line Pilots Association, International (ALPA) indicated its support for the NPRM.

    Conclusion

    We reviewed the relevant data, considered the comment received, and determined that air safety and the public interest require adopting this final rule as proposed, except for minor editorial changes. We have determined that these minor changes:

    • Are consistent with the intent that was proposed in the NPRM for addressing the unsafe condition; and

    • Do not add any additional burden upon the public than was already proposed in the NPRM.

    Related Service Information Under 1 CFR Part 51

    Bombardier has issued the following service information:

    • Service Bulletin 8-52-65, dated July 26, 2017, which describes procedures for a detailed inspection of the forward right-hand type I emergency exit door ball bearings for corrosion, seal damage, and loss of lubricant; applying CIC; and replacing emergency exit door ball bearings if necessary.

    • de Havilland Inc. Dash 8 Series 300 MaintenanceTask Card Task Number 5220/12 (“Servicing of Forward RH Emergency Exit Mechanisms”), dated March 15, 2017, which describes procedures for servicing the forward right-hand emergency exit door mechanisms.

    • Temporary Revision (TR) 54-042, dated April 10, 2018, to the DHC-8-300 Aircraft Maintenance Manual (AMM), which describes procedures for servicing the type I emergency exit door mechanisms.

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

    Costs of Compliance

    We estimate that this AD affects 16 airplanes of U.S. registry.

    We estimate the following costs to comply with this AD:

    Estimated Costs for Required Actions Labor cost Parts cost Cost per
  • product
  • Cost on U.S. operators
    3 work-hours × $85 per hour = $255 $0 $255 $4,080

    We have determined that revising the maintenance or inspection program takes an average of 90 work-hours per operator, although we recognize that this number may vary from operator to operator. In the past, we have estimated that this action takes 1 work-hour per airplane. Since operators incorporate maintenance or inspection program changes for their affected fleet(s), we have determined that a per-operator estimate is more accurate than a per-airplane estimate. Therefore, we estimate the total cost per operator to be $7,650 (90 work-hours × $85 per work-hour).

    We estimate the following costs to do any necessary on-condition actions that would be required based on the results of any required actions. We have no way of determining the number of aircraft that might need these on-condition actions:

    Estimated Costs of On-Condition Actions Labor cost Parts cost Cost per
  • product
  • 6 work-hours × $85 per hour = $510 $586 $1,096
    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 and associated appliances to the Director of the System Oversight Division.

    Regulatory Findings

    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): 2018-20-11 Bombardier, Inc.: Amendment 39-19445; Docket No. FAA-2018-0586; Product Identifier 2017-NM-151-AD. (a) Effective Date

    This AD is effective November 23, 2018.

    (b) Affected ADs

    None.

    (c) Applicability

    This AD applies to Bombardier, Inc., Model DHC-8-301, -311, and -315 airplanes, certificated in any category, serial numbers 100 through 672 inclusive.

    (d) Subject

    Air Transport Association (ATA) of America Code 52, Doors.

    (e) Reason

    This AD was prompted by reports indicating that the forward right-hand type I emergency exit door could not be opened during maintenance. An investigation determined that the exit door handle was jammed due to corroded center and lower shaft ball bearings. We are issuing this AD to address corrosion of the emergency exit door ball bearings, which could result in the inability to open the emergency exit door during an emergency evacuation and consequently impede airplane egress.

    (f) Compliance

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

    (g) Revision of Maintenance or Inspection Program

    Within 60 days after the effective date of this AD: Revise the maintenance or inspection program, as applicable, to incorporate de Havilland Inc. Dash 8 Series 300 Maintenance Task Card Task Number 5220/12 (“Servicing of Forward RH Emergency Exit Mechanisms”), dated March 15, 2017; and Temporary Revision 54-042, dated April 10, 2018, to the DHC-8-300 Aircraft Maintenance Manual (AMM). The initial compliance time for doing the task is at the time specified in de Havilland Inc. Dash 8 Series 300 Maintenance Task Card Task Number 5220/12 (“Servicing of Forward RH Emergency Exit Mechanisms”), dated March 15, 2017, or within 60 days after the effective date of this AD, whichever occurs later.

    (h) Inspection and Replacement

    Within 5,000 flight hours or 36 months, whichever occurs first, after the effective date of this AD: Do a detailed inspection of all ball bearings of the forward right-hand type I emergency exit for corrosion, seal damage, and loss of lubricant; replace bearings as applicable; and apply corrosion inhibiting compound (CIC); in accordance with the Accomplishment Instructions of Bombardier Service Bulletin 8-52-65, dated July 26, 2017. Do all applicable replacements before further flight.

    (i) No Alternative Actions or Intervals

    After the maintenance or inspection program has been revised as required by paragraph (g) of this AD, no alternative actions (e.g., inspections) or intervals may be used unless the actions and intervals are approved as an alternative method of compliance (AMOC) in accordance with the procedures specified in paragraph (j)(1) of this AD.

    (j) Other FAA AD Provisions

    The following provisions also apply to this AD:

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

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

    (k) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information (MCAI) Canadian Airworthiness Directive CF-2017-30, dated August 30, 2017, for related information. This MCAI may be found in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-0586.

    (2) For more information about this AD, contact Darren Gassetto, Aerospace Engineer, Airframe and Propulsion Section, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-7323; fax 516-794-5531; email [email protected]

    (l) 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) Bombardier Service Bulletin 8-52-65, dated July 26, 2017.

    (ii) de Havilland Inc. Dash 8 Series 300 Maintenance Task Card Task Number 5220/12 (“Servicing of Forward RH Emergency Exit Mechanisms”), dated March 15, 2017.

    (iii) Temporary Revision (TR) 54-042, dated April 10, 2018, to the DHC-8-300 Aircraft Maintenance Manual (AMM).

    (3) For service information identified in this AD, contact Bombardier, Inc., Q-Series Technical Help Desk, 123 Garratt Boulevard, Toronto, Ontario M3K 1Y5, Canada; telephone 416-375-4000; fax 416-375-4539; email [email protected]; internet http://www.bombardier.com.

    (4) You may view this service information at the FAA, Transport Standards Branch, 2200 South 216th St., Des Moines, WA. For information on the availability of this material at the FAA, call 206-231-3195.

    (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 Des Moines, Washington, on September 20, 2018. John P. Piccola, Acting Director, System Oversight Division, Aircraft Certification Service.
    [FR Doc. 2018-22148 Filed 10-17-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2018-0161; Product Identifier 2017-NM-088-AD; Amendment 39-19450; AD 2018-20-16] RIN 2120-AA64 Airworthiness Directives; Bombardier, Inc., Airplanes AGENCY:

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

    ACTION:

    Final rule.

    SUMMARY:

    We are superseding Airworthiness Directive (AD) 2013-11-12, which applied to certain Bombardier, Inc., Model BD-100-1A10 airplanes. AD 2013-11-12 required inspecting for the correct serial number of a certain hydraulic system accumulator, and replacing affected hydraulic system accumulators with new or serviceable accumulators. This AD expands the applicability and requires modifying or replacing certain hydraulic brake system accumulators. This AD also requires revising the maintenance or inspection program to add life limits for the accumulators. This AD was prompted by a determination that certain other hydraulic system accumulators must be modified or replaced and life limits must be added. We are issuing this AD to address the unsafe condition on these products.

    DATES:

    This AD is effective November 23, 2018.

    The Director of the Federal Register approved the incorporation by reference of certain publications listed in this AD as of November 23, 2018.

    The Director of the Federal Register approved the incorporation by reference of a certain other publication listed in this AD as of July 9, 2013 (78 FR 33206, June 4, 2013).

    ADDRESSES:

    For service information identified in this final rule, contact Bombardier, Inc., 400 Côte-Vertu Road West, Dorval, Québec H4S 1Y9, Canada; telephone 514-855-5000; fax 514-855-7401; email [email protected]; internet http://www.bombardier.com. You may view this referenced service information at the FAA, Transport Standards Branch, 2200 South 216th St., Des Moines, WA. For information on the availability of this material at the FAA, call 206-231-3195. It is also available on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-0161.

    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-2018-0161; or in person at Docket Operations between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this final rule, the regulatory evaluation, any comments received, and other information. The address for Docket Operations (phone: 800-647-5527) is U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590.

    FOR FURTHER INFORMATION CONTACT:

    Cesar Gomez, Aerospace Engineer, Airframe and Mechanical Systems Section, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-7318; fax 516-794-5531.

    SUPPLEMENTARY INFORMATION: Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to supersede AD 2013-11-12, Amendment 39-17472 (78 FR 33206, June 4, 2013) (“AD 2013-11-12”). AD 2013-11-12 applied to certain Bombardier, Inc., Model BD-100-1A10 airplanes. The NPRM published in the Federal Register on March 9, 2018 (83 FR 10415). The NPRM was prompted by a determination that certain other hydraulic system accumulators must be modified or replaced and life limits must be added. The NPRM proposed to continue to require inspecting for the correct serial number of a certain hydraulic system accumulator, and replacing affected hydraulic system accumulators with new or serviceable accumulators. The NPRM also proposed to expand the applicability and require modifying or replacing certain hydraulic brake system accumulators. The NPRM also proposed to require revising the maintenance or inspection program to add life limits for the accumulators. We are issuing this AD to prevent failure of a screw cap or end cap and loss of the related hydraulic system, which could result in damage to airplane structure and consequent reduced controllability of the airplane.

    Transport Canada Civil Aviation (TCCA), which is the aviation authority for Canada, has issued Canadian Airworthiness Directive CF-2011-41R1, dated March 27, 2017 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Bombardier, Inc. Model BD-100-1A10 airplanes. The MCAI states:

    Seven cases of on-ground hydraulic accumulator screw cap/end cap failure have been experienced on CL-600-2B19 aeroplanes, resulting in loss of the associated hydraulic system and high-energy impact damage to adjacent systems and structure. To date, the lowest number of flight cycles accumulated at the time of failure has been 6991.

    Although there have been no failures to date on any BD-100-1A10 aeroplanes, accumulators similar to those installed on the CL-600-2B19 are installed on the BD-100-1A10. The affected part numbers (P/Ns) of the accumulators installed on BD-100-1A10 are 900095-1 (Auxiliary Hydraulic System accumulator), 33-155500 (Inboard Brake accumulator), and 33-147500 (Outboard Brake accumulator).

    A detailed analysis of the calculated line of trajectory of a failed screw cap/end cap for the accumulators has been conducted, resulting in the identification of areas where systems and/or structural components could potentially be damaged. Although all of the failures on the CL-600-2B19 to date have occurred on the ground, an in-flight failure affecting such components could potentially have an adverse effect on the controllability of the aeroplane.

    Revision 1 of this [Canadian] AD is issued to mandate the [inspection and] replacement [of] Brake System Hydraulic accumulators that are not identified by the letter “E” or “NAE” after the serial number on the identification plate. Revision 1 also mandates the re-orientation of the brake accumulators P/N 33-147500 and P/N 33-155500 and the insertion of three discard tasks in the Challenger 300 Time Limits/Maintenance Checks (TLMC) Manual.

    You may examine the MCAI in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-0161.

    Comments

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

    Request To Add Maintenance Manual

    NetJets Aviation stated that paragraph (n) of the proposed AD, which requires revising the maintenance or inspection program to incorporate certain life limit tasks, does not reference the Bombardier Challenger 350 Time Limits/Maintenance Check (TLMC) Manual. NetJets Aviation noted that only the Bombardier Challenger 300 TLMC Manual is referenced.

    We infer that the commenter is asking that the Bombardier Challenger 350 TLMC Manual be added as another source of service information for accomplishing the actions required by paragraph (n) of this AD. We agree with the commenter's request and have changed paragraph (n) accordingly. Although the tasks identified in the Bombardier Challenger 300 TLMC Manual also apply to Bombardier Challenger 350 airplanes, we have included the Bombardier Challenger 350 TLMC in this AD for clarity.

    Conclusion

    We reviewed the relevant data, considered the comment received, and determined that air safety and the public interest require adopting this final rule with the change described previously and minor editorial changes. We have determined that these minor changes:

    • Are consistent with the intent that was proposed in the NPRM for addressing the unsafe condition; and

    • Do not add any additional burden upon the public than was already proposed in the NPRM.

    We also determined that this change will not increase the economic burden on any operator or increase the scope of this final rule.

    Related Service Information Under 1 CFR Part 51

    Bombardier has issued the following service information:

    • Service Bulletin 100-32-20, Revision 02, dated April 14, 2015, which describes procedures for modifying (e.g., re-orienting) the installation of the hydraulic brake accumulators.

    • Service Bulletin 100-32-21, dated May 24, 2012, which describes procedures for replacing the hydraulic brake system accumulators.

    • Task 29-21-13-101 Discard the Auxiliary Hydraulic System Accumulator, Part No. 900095-1, of Section 5-10-11 of Part 2, “Airworthiness Limitations,” of Bombardier Challenger 300 BD-100 Time Limits/Maintenance Checks Manual, Revision 17, dated December 15, 2016; and Bombardier Challenger 350, BD-100 Time Limits/Maintenance Checks Manual, Revision 9, dated December 18, 2017, which describes procedures for removal and installation of the hydraulic brake system accumulators. These tasks are distinct since they apply to different airplane models.

    • Task 32-43-37-101 Discard the Brake Accumulator, Part No. 33-147500, of Section 5-10-11 of Part 2, “Airworthiness Limitations,” of Bombardier Challenger 300 BD-100 Time Limits/Maintenance Checks Manual, Revision 17, dated December 15, 2016; and Bombardier Challenger 350, BD-100 Time Limits/Maintenance Checks Manual, Revision 9, dated December 18, 2017, which describes procedures for removal and installation of the brake accumulators. These tasks are distinct since they apply to different airplane models.

    • Task 32-44-05-101 Discard the Emergency/Parking Brake Accumulator, Part No. 33-155500, of Section 5-10-11 of Part 2, “Airworthiness Limitations,” of Bombardier Challenger 300 BD-100 Time Limits/Maintenance Checks Manual, Revision 17, dated December 15, 2016; and Bombardier Challenger 350, BD-100 Time Limits/Maintenance Checks Manual, Revision 9, dated December 18, 2017, which describes procedures for removal and installation of the emergency parking brake accumulators. These tasks are distinct since they apply to different airplane models.

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

    Costs of Compliance

    We estimate that this AD affects 187 airplanes of U.S. registry.

    We estimate the following costs to comply with this AD:

    Estimated Costs Action Labor cost Parts cost Cost per product Cost on U.S.
  • operators
  • Inspection to determine part numbers (retained actions from AD 2013-11-12) 1 work-hour × $85 per hour = $85 $0 $85 $15,895. Modifying or replacing hydraulic brake system accumulators (new actions) 58 work-hours × $85 per hour = $4,930 Up to $31,500 Up to $36,430 Up to $6,812,410.

    We have determined that revising the maintenance or inspection program takes an average of 90 work-hours per operator, although we recognize that this number may vary from operator to operator. In the past, we have estimated that this action takes 1 work-hour per airplane. Since operators incorporate maintenance or inspection program changes for their affected fleet(s), we have determined that a per-operator estimate is more accurate than a per-airplane estimate. Therefore, we estimate the total cost per operator to be $7,650 (90 work-hours × $85 per work-hour).

    We estimate the following costs to do any necessary replacements that will be required based on the results of the inspection. We have no way of determining the number of aircraft that might need these replacements.

    On-Condition Costs Action Labor cost Parts cost Cost per
  • product
  • Hydraulic accumulator replacement 5 work-hours × $85 per hour = $340 $4,510 $4,850
    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 removing Airworthiness Directive (AD) 2013-11-12, Amendment 39-17472 (78 FR 33206, June 4, 2013), and adding the following new AD: 2018-20-16 Bombardier, Inc.: Amendment 39-19450; Docket No. FAA-2018-0161; Product Identifier 2017-NM-088-AD. (a) Effective Date

    This AD is effective November 23, 2018.

    (b) Affected ADs

    This AD replaces AD 2013-11-12, Amendment 39-17472 (78 FR 33206, June 4, 2013) (“AD 2013-11-12”).

    (c) Applicability

    This AD applies to Bombardier, Inc., Model BD-100-1A10 airplanes, certificated in any category, having serial numbers 20003 through 20604 inclusive.

    (d) Subject

    Air Transport Association (ATA) of America Code 29, Hydraulic Power.

    (e) Reason

    This AD was prompted by reports of failure of a screw cap or end cap of the hydraulic system accumulator while on the ground, which resulted in loss of use of that hydraulic system and high-energy impact damage to adjacent systems and structures. We are issuing this AD to prevent failure of a screw cap or end cap and loss of the related hydraulic system, which could result in damage to airplane structure and consequent reduced controllability of the airplane.

    (f) Compliance

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

    (g) Retained Inspection With No Changes

    This paragraph restates the requirements of paragraph (g) of AD 2013-11-12 with no changes. For airplanes having serial numbers 20003 through 20335 inclusive: At the applicable time specified in paragraph (g)(1), (g)(2), or (g)(3) of this AD: Inspect the identification plate on the hydraulic system accumulator having part number (P/N) 900095-1 to determine if an “E” is part of the suffix of the serial number stamped on the identification plate, as listed in paragraph 2.B. of the Accomplishment Instructions of Bombardier Service Bulletin 100-29-14, dated December 16, 2010. A review of airplane maintenance records is acceptable in lieu of this inspection if the suffix of the serial number can be conclusively determined from that review.

    (1) For an accumulator that has accumulated more than 3,150 total flight cycles as of July 9, 2013 (the effective date of AD 2013-11-12), inspect that accumulator within 350 flight cycles after July 9, 2013.

    (2) For an accumulator that has accumulated 3,150 or fewer total flight cycles as of July 9, 2013 (the effective date of AD 2013-11-12), inspect that accumulator before it has accumulated 3,500 total flight cycles.

    (3) For an accumulator on which it is not possible to determine the total flight cycles accumulated as of July 9, 2013 (the effective date of AD 2013-11-12), inspect that accumulator within 350 flight cycles after July 9, 2013.

    (h) Retained Replacement With No Changes

    This paragraph restates the requirements of paragraph (h) of AD 2013-11-12 with no changes. If, during the inspection required by paragraph (g) of this AD, any accumulator having P/N 900095-1 is found on which the letter “E” is not part of the suffix of the serial number on the identification plate: Before further flight, replace the accumulator with a new or serviceable accumulator, in accordance with paragraph 2.C. of the Accomplishment Instructions of Bombardier Service Bulletin 100-29-14, dated December 16, 2010.

    (i) Retained Parts Installation Prohibition With No Changes

    This paragraph restates the requirements of paragraph (i) of AD 2013-11-12 with no changes. For airplanes having serial numbers 20003 through 20335 inclusive: As of July 9, 2013 (the effective date of AD 2013-11-12), no person may install on any airplane a hydraulic system accumulator having P/N 900095-1, on which the letter “E” is not part of the suffix of the serial number on the identification plate.

    (j) New Requirement of This AD: Replacement of Brake System Hydraulic Accumulators

    For airplanes having serial numbers 20003 through 20347 inclusive: At the applicable time specified in paragraph (j)(1), (j)(2), or (j)(3) of this AD, replace all brake system hydraulic accumulators having P/N 33-147500 or P/N 33-155500 that are not identified by the letter “E” or “NAE” after the serial number on the identification plate with an accumulator of the same part number that is identified by the letter “E” or “NAE” after the serial number. Do the replacement in accordance with the Accomplishment Instructions of Bombardier Service Bulletin 100-32-21, dated May 24, 2012.

    (1) For an accumulator that has accumulated more than 4,700 total flight cycles as of the effective date of this AD, inspect that accumulator within 300 flight cycles after the effective date of this AD.

    (2) For an accumulator that has accumulated 4,700 or fewer total flight cycles as of the effective date of this AD, inspect that accumulator before it has accumulated 5,000 total flight cycles.

    (3) For an accumulator on which it is not possible to determine the total flight cycles accumulated as of the effective date of this AD, inspect that accumulator within 300 flight cycles after the effective date of this AD.

    (k) New Requirement of This AD: Additional Parts Installation Prohibition

    For airplanes having serial numbers 20003 through 20347 inclusive: As of the effective date of this AD, no person may install on any airplane a hydraulic system accumulator having P/N 33-147500 or P/N 33-155500, on which the letter “E” or “NAE” is not after the serial number on the identification plate.

    (l) New Requirement of This AD: Modification of the Inboard and Outboard Brake Accumulators

    For airplanes having serial numbers 20003 through 20395 inclusive: Within 1,600 flight hours or 14 months after the effective date of this AD, whichever occurs first, modify (re-orient) the installation of the inboard and outboard brake accumulators, in accordance with the Accomplishment Instructions of Bombardier Service Bulletin 100-32-20, Revision 02, dated April 14, 2015.

    (m) Credit for Previous Actions

    This paragraph provides credit for the actions specified in paragraph (l) of this AD, if those actions were performed before the effective date of this AD using Bombardier Service Bulletin 100-32-20, dated February 25, 2013; or Revision 01, dated March 5, 2015.

    (n) New Requirement of This AD: Maintenance or Inspection Program Revision

    For airplanes having serial numbers 20003 through 20604 inclusive: Within 30 days after the effective date of this AD, revise the maintenance or inspection program, as applicable, to incorporate life limit tasks 29-21-13-101, 32-43-37-101, and 32-44-05-101 of Section 5-10-11 of Part 2, “Airworthiness Limitations”, of Bombardier Challenger 300 BD-100 Time Limits/Maintenance Checks Manual, Revision 17, dated December 15, 2016; or Bombardier Challenger 350 BD-100 Time Limits/Maintenance Checks Manual, Revision 9, dated December 18, 2017, as applicable. The initial compliance time for the tasks is within the applicable time specified in that service information, or within 30 days after the effective date of this AD, whichever occurs later.

    (o) No Alternative Actions and Intervals

    After the maintenance or inspection program has been revised as required by paragraph (n) of this AD, no alternative actions (e.g., inspections) or intervals may be used unless the actions or intervals are approved as an alternative method of compliance (AMOC) in accordance with the procedures specified in paragraph (p)(1) of this AD.

    (p) Other FAA AD Provisions

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

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

    (q) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information (MCAI) Canadian Airworthiness Directive CF-2011-41R1, dated March 27, 2017, for related information. This MCAI may be found in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-0161.

    (2) For more information about this AD, contact Cesar Gomez, Aerospace Engineer, Airframe and Mechanical Systems Section, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone: 516-228-7318; fax: 516-794-5531.

    (3) Service information identified in this AD that is not incorporated by reference is available at the addresses specified in paragraphs (r)(5) and (r)(6) of this AD.

    (r) 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.

    (3) The following service information was approved for IBR on November 23, 2018.

    (i) Bombardier Service Bulletin 100-32-20, Revision 02, dated April 14, 2015.

    (ii) Bombardier Service Bulletin 100-32-21, dated May 24, 2012.

    (iii) Bombardier Challenger 300 BD-100 Time Limits/Maintenance Checks Manual, Revision 17, dated December 15, 2016, Part 2, Airworthiness Limitations, Section 5-10-11:

    (A) Task 29-21-13-101 Discard the Auxiliary Hydraulic System Accumulator, Part No. 900095-1;

    (B) Task 32-43-37-101 Discard the Brake Accumulator, Part No. 33-147500;

    (C) Task 32-44-05-101 Discard the Emergency/Parking Brake Accumulator, Part No. 33-155500.

    (iv) Bombardier Challenger 350 BD-100 Time Limits/Maintenance Checks Manual, Revision 9, dated December 18, 2017, Part 2, Airworthiness Limitations, Section 5-10-11:

    (A) Task 29-21-13-101 Discard the Auxiliary Hydraulic System Accumulator, Part No. 900095-1;

    (B) Task 32-43-37-101 Discard the Brake Accumulator, Part No. 33-147500;

    (C) Task 32-44-05-101 Discard the Emergency/Parking Brake Accumulator, Part No. 33-155500.

    (4) The following service information was approved for IBR on July 9, 2013 (78 FR 33206, June 4, 2013).

    (i) Bombardier Service Bulletin 100-29-14, dated December 16, 2010.

    (ii) Reserved.

    (5) For service information identified in this AD, contact Bombardier, Inc., 400 Côte-Vertu Road West, Dorval, Québec H4S 1Y9, Canada; telephone 514-855-5000; fax 514-855-7401; email [email protected]; internet http://www.bombardier.com.

    (6) You may view this service information at the FAA, Transport Standards Branch, 2200 South 216th St., Des Moines, WA. For information on the availability of this material at the FAA, call 206-231-3195.

    (7) 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 Des Moines, Washington, on September 25, 2018. John P. Piccola, Acting Director, System Oversight Division, Aircraft Certification Service.
    [FR Doc. 2018-22137 Filed 10-17-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 15 CFR Part 902 50 CFR Parts 300 and 679 [Docket No. 170626590-8785-02] RIN 0648-BG94 Fisheries of the Exclusive Economic Zone off Alaska; Pacific Halibut and Sablefish Individual Fishing Quota Program; Community Development Quota Program; Modifications to Recordkeeping and Reporting Requirements AGENCY:

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

    ACTION:

    Final rule.

    SUMMARY:

    NMFS issues a final rule that modifies regulations governing the Halibut and Sablefish Individual Fishing Quota (IFQ) Program. This rule includes three actions. The first action allows Western Alaska Community Development Quota (CDQ) groups to lease (to receive by transfer) halibut IFQ in IFQ regulatory areas 4B, 4C, and 4D in years of extremely low halibut commercial catch limits. This action is necessary to provide additional harvest opportunities to CDQ groups and community residents, and provide IFQ holders with the opportunity to receive value for their IFQ when the halibut commercial catch limits may not be large enough to provide for an economically viable fishery for IFQ holders. The second action removes an obsolete reference in the IFQ Program regulations. The third action clarifies IFQ vessel use cap regulations. This final rule is intended to promote the goals and objectives of the Northern Pacific Halibut Act of 1982 (Halibut Act), the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), the Fishery Management Plan (FMP) for Groundfish of the Bering Sea and Aleutian Islands (BSAI) Management Area, and other applicable laws.

    DATES:

    This rule is effective on November 19, 2018.

    ADDRESSES:

    Electronic copies of the Regulatory Impact Review (Analysis) prepared for this action are available from http://www.regulations.gov or from the NMFS Alaska Region website at http://alaskafisheries.noaa.gov.

    Written comments regarding the burden-hour estimates or other aspects of the collection-of-information requirements contained in this final rule may be submitted by mail to NMFS, Alaska Region, P.O. Box 21668, Juneau, AK 99082-1668, Attn: Ellen Sebastian, Records Officer; in person at NMFS, Alaska Region, 709 West 9th Street, Room 420A, Juneau, AK; and by email to [email protected] or by fax to (202) 395-5806.

    FOR FURTHER INFORMATION CONTACT:

    Stephanie Warpinski, (907) 586-7228.

    SUPPLEMENTARY INFORMATION: Authority for Action

    The International Pacific Halibut Commission (IPHC) and NMFS manage fishing for Pacific halibut through regulations established under the authority of the Halibut Act. The IPHC promulgates regulations governing the halibut fishery under the Convention between the United States and Canada for the Preservation of the Halibut Fishery of the Northern Pacific Ocean and Bering Sea (Convention). The IPHC's regulations are subject to approval by the Secretary of State with the concurrence of the Secretary of Commerce (Secretary). NMFS publishes the IPHC's regulations as annual management measures pursuant to 50 CFR 300.62.

    The Halibut Act, at sections 773c(a) and (b), provides the Secretary with general responsibility to carry out the Convention and the Halibut Act. The Halibut Act, at section 773c(c), also provides the North Pacific Fishery Management Council (Council) with authority to develop regulations, including limited access regulations, that are in addition to, and not in conflict with, approved IPHC regulations. Regulations developed by the Council may be implemented by NMFS only after approval by the Secretary.

    The Council developed the IFQ Program for the commercial halibut and sablefish fisheries. The IFQ Program for the halibut fishery is implemented by Federal regulations at 50 CFR part 679 under the authority of section 773 of the Halibut Act. The IFQ Program for the sablefish fishery is implemented by the BSAI FMP and Federal regulations at 50 CFR part 679 under the authority of section 303(b) of the Magnuson-Stevens Act.

    Background

    On February 23, 2018, NMFS published a proposed rule (83 FR 8028) and invited public comment. The following summarizes the IFQ Program, the CDQ Program, the need for this final rule, and the anticipated effects of the final rule. Additional detail about the action is provided in the preamble of the proposed rule and in the Analysis.

    The IFQ Program

    The IFQ Program for the management of the fixed gear (hook-and-line and pot gear) halibut and sablefish fisheries off Alaska was implemented by NMFS in 1995 (58 FR 59375, November 9, 1993). A central objective of the IFQ Program is to support the social and economic character of the fisheries and the coastal fishing communities where many of these fisheries are based. A detailed description of the IFQ Program can be found in the proposed rule for this action (83 FR 8028, February 23, 2018) and the Analysis.

    Under the IFQ Program, access to the fixed gear sablefish and halibut fisheries is limited to those persons holding quota share (QS). QS is an exclusive, revocable privilege that allows the holder to harvest a specific percentage of either the total allowable catch (TAC) in the sablefish fishery or the annual commercial catch limit in the halibut fishery. QS is designated for specific geographic areas of harvest, a specific vessel operation type (catcher vessel or catcher/processor), and for a specific range of vessel sizes that may be used to harvest the sablefish or halibut (vessel category).

    This final rule uses the term “Area” to refer to a specific IFQ regulatory area. The IFQ Program designates four vessel categories of halibut QS: Category A shares designated for catcher/processors, vessels that process their catch at sea, and do not have a vessel length restriction; Category B shares designated for catcher vessels greater than 60 feet length overall (LOA); Category C shares designated for catcher vessels greater than 35 feet but less than or equal to 60 feet LOA; and Category D shares designated for catcher vessels less than or equal to 35 feet LOA.

    NMFS annually issues IFQ permits to each QS holder. An annual IFQ permit authorizes the permit holder to harvest a specified amount of the IFQ species in a regulatory area from a specific operation type and vessel category. The Council and the public frequently use the terms “IFQ lease” or “lease” to refer to the transfer of IFQ without a transfer of the underlying quota shares (QS). However, NMFS does not generally use the term “lease” in its IFQ Program regulations governing the transfer of IFQ. Therefore, for consistency with the terminology used in the existing regulations and for clarity, this rule uses the term “transfer of IFQ.”

    NMFS issues halibut IFQ consistent with the IPHC's regulatory areas. NMFS' IFQ regulatory areas (Areas) are defined in 50 CFR part 679 and described in Figure 15 to part 679 and Section 1.3 of the Analysis. The first action in this rule pertains to Areas 4B, 4C, 4D, and 4E. Area 4B includes waters in the Central and Western Aleutian Islands. Areas 4C, 4D, and 4E include waters north of the Aleutian Islands, in the Bering Sea, and around the Pribilof Islands. The IPHC considers Areas 4C, 4D, and 4E a single stock unit for assessment and management purposes, and the combined Areas are referred to as Area 4CDE in this final rule.

    The commercial catch limits for Areas 4B and 4CDE are allocated between two distinct management programs, the CDQ Program and the IFQ Program. Throughout the duration of the IFQ Program, the Area 4E commercial catch limit has been exclusively allocated to the CDQ Program; therefore, no Area 4E QS or IFQ is allocated.

    Overall, the halibut IFQ commercial catch limits in Areas 4B and 4CDE have trended downward over the past 15 years (see Section 3.6.1 of the Analysis). The Area 4B commercial catch limit has dropped substantially from 2001 to 2015. In 2015, the Area 4B commercial catch limit for IFQ was less than a quarter of what it was in 2001. The combined commercial catch limit for IFQ in Areas 4C and 4D has seen more fluctuation during this period, but has still experienced an overall downward trend since 2007. In 2007, the combined commercial catch limit for IFQ in Areas 4C and 4D was about 2.2 million pounds; in 2015, it was about 0.7 million pounds.

    The CDQ Program

    The CDQ Program was implemented in 1992, and in 1996, the Magnuson-Stevens Act was amended to include provisions specific to the CDQ Program. The purposes of the CDQ Program are (1) to provide eligible western Alaska villages with the opportunity to participate and invest in fisheries in the BSAI management area; (2) to support economic development in western Alaska; (3) to alleviate poverty and provide economic and social benefits for residents of western Alaska; and (4) to achieve sustainable and diversified local economies in western Alaska (16 U.S.C. 1855(i)(1)(A)).

    The CDQ Program consists of six different non-profit managing organizations (CDQ groups) representing different geographical regions in Alaska. The CDQ Program receives annual allocations of TAC for a variety of commercially valuable species in the BSAI groundfish, crab, and halibut fisheries, which are in turn allocated among the CDQ groups. Among the species CDQ groups are allocated for commercial fishing, Pacific halibut is an important species for community resident employment and income. NMFS allocates halibut to CDQ groups for commercial fisheries in four Areas: 4B, 4C, 4D, and 4E (see Section 3.5.1 of the Analysis). See Section 3.5.2 of the Analysis for additional detail on the history of the halibut CDQ fishery.

    The resident halibut CDQ fleets and criteria for participation in CDQ fisheries vary among the CDQ groups. The resident halibut CDQ fleets are impacted by internal economic decisions made by the CDQ groups and in the ways the CDQ groups choose to promote economic development in their communities. Many of the small boat fishermen in CDQ communities are dependent on the halibut fishery (Section 3.5.3 of the Analysis).

    Need for Action

    The downward trend of halibut commercial catch limits in Areas 4B and 4CDE over the past 15 years has been dramatic, with current limits significantly lower than those of the recent past years. The recent years of low halibut abundance and the resulting low commercial catch limits in Areas 4B and 4CDE have made it increasingly difficult for most CDQ groups to create a viable commercial halibut fishing opportunity for their community residents.

    Under current regulations, CDQ groups cannot receive by transfer any IFQ derived from catcher vessel QS. Current regulations also prohibit halibut QS holders from transferring their IFQ separately from the underlying QS except in very narrow, specific situations (see Section 3.7 of the Analysis for more information).

    To address these problems, this final rule creates a voluntary option for IFQ holders in Areas 4B, 4C, or 4D to temporarily transfer their halibut IFQ to a CDQ group in years of extremely low halibut abundance. This flexibility allows CDQ groups to expand the fishing opportunities for the small boat fleets operating out of the CDQ group's communities and provides IFQ holders with the opportunity to receive value for their IFQ when extremely low halibut commercial catch limits may not be large enough to provide for an economically viable fishery for IFQ holders.

    This Final Rule and the Anticipated Effects

    This final rule includes three actions. The primary action, Action 1, creates a voluntary option for an IFQ holder to temporarily transfer his or her halibut IFQ to a CDQ group in years of extremely low halibut abundance. Actions 2 and 3 make minor regulatory adjustments to remove an obsolete reference in the IFQ Program regulations and to clarify IFQ vessel use cap regulations, respectively. The following paragraphs provide additional detail on the actions.

    Action 1

    This final rule (1) defines the halibut commercial catch limits under which CDQ groups may receive IFQ by transfer, (2) establishes limits on the types and amounts of IFQ that can be transferred, and (3) establishes reporting requirements for CDQ groups receiving IFQ by transfer. This final rule does not convert transferred IFQ to CDQ. Allocations of halibut CDQ will not change under this final rule.

    Under this final rule, CDQ groups may receive transfers of halibut catcher vessel IFQ (Categories B, C, and D IFQ) in Areas 4C and 4D when the halibut annual commercial catch limit is less than 1.5 million pounds in Area 4CDE. CDQ groups may receive transfers of halibut catcher vessel IFQ (Categories B, C, and D IFQ) in Area 4B when the annual halibut commercial catch limit is less than 1 million pounds in Area 4B. IFQ holders may transfer both blocked and unblocked IFQ to CDQ groups. This final rule does not revise current regulations that authorize an IFQ holder in Areas 4B, 4C and 4D to transfer his or her Category A halibut IFQ to any qualified person, including a CDQ group. However, as explained later, this rule provides additional harvesting flexibility for Category A halibut IFQ transferred to a CDQ group in years of extremely low halibut abundance.

    The Council recommended and NMFS is implementing these thresholds based on an analysis of commercial catch limits between 2008 and 2017, a period of time representing a range of different halibut commercial catch limits and decreasing opportunities for CDQ community fishermen. The Council considered a range of different commercial catch limit thresholds for both Areas 4B and 4CDE before selecting these thresholds. The preamble to the proposed rule provides additional information on the factors considered by the Council and NMFS (83 FR 8028, March 26, 2018).

    These thresholds are intended to balance the goal of providing additional halibut fishing opportunities for CDQ residents when the halibut CDQ allocation alone may not be large enough to sustain small vessel resident fisheries, with the need to avoid potential adverse distributional impacts on other halibut IFQ users that could result if IFQ transfers were permitted without restrictions. These thresholds provide the flexibility to transfer halibut IFQ in Areas 4B, 4C, and 4D only during worst case scenarios for halibut commercial catch limits in these areas (Section 2.3 of the Analysis). For Area 4CDE, the Council determined and NMFS agrees that a halibut commercial catch limit below 1.5 million pounds reflects a worst case scenario for Area 4CDE as it represents an extremely low commercial catch limit for these areas. For Area 4B, the Council determined and NMFS agrees that a halibut commercial catch limit below 1 million pounds, which has not been experienced during the last 10 years, reflects a worst case scenario for Area 4B as it represents an extremely low commercial catch limit for this area.

    This final rule establishes several limits on the catcher vessel IFQ that can be transferred while providing some flexibility with transferred catcher vessel and catcher/processor IFQ. The rationale for the limits can be found in Section 2.2 of the Analysis and in the preamble to the proposed rule (83 FR 8028, March 26, 2018). The limits are: (1) A CDQ group will be able to receive catcher vessel IFQ by transfer only for an area in which it also holds halibut CDQ; (2) no vessel greater than 51 feet length overall (LOA) may be used to harvest catcher vessel IFQ transferred to a CDQ group; (3) catcher vessel IFQ resulting from QS acquired after December 14, 2015, may not be transferred to a CDQ group until 3 years after the QS was acquired (i.e., a cooling off period); (4) an IFQ holder will not be allowed to transfer catcher vessel halibut IFQ to a CDQ group for more than 2 consecutive years; and (5) in Area 4B, only those QS holders who hold fewer than 76,355 QS units specified for Area 4B will be allowed to transfer their catcher vessel IFQ to CDQ groups.

    The first limit prevents a CDQ group from receiving catcher vessel halibut IFQ by transfer for an area in which that CDQ group does not hold halibut CDQ. The Council recommended and NMFS is implementing this limit so that any catcher vessel IFQ transferred to a CDQ group is available for use in conjunction with halibut CDQ that is issued to a CDQ group.

    Additionally, under this final rule at § 679.42(a)(1)(iii), a CDQ group that is eligible to receive a transfer of Area 4D catcher vessel IFQ will be able to harvest that IFQ, and any Category A IFQ it holds, in Area 4E (Section 3.5.2 of the Analysis). This flexibility is consistent with section 12(8) of the IPHC annual management measures (83 FR 10390, March 9, 2018), which allows Area 4D halibut CDQ to be harvested in Area 4E.

    The second limit prohibits the use of vessels greater than 51 feet LOA to harvest catcher vessel IFQ that is transferred to a CDQ group. The Council recommended and NMFS is implementing this vessel size limit because this is the largest size vessel owned by CDQ community residents that has landed halibut CDQ during the past 10 years, 2008 through 2017 (Section 3.5.3 of the Analysis). Current regulations provide sufficient flexibility to allow IFQ that could be transferred to a CDQ group under this final rule to be fished on a vessel of any length up to 51 feet LOA (see Section 2.4 of the Analysis).

    This final rule clarifies that any Area 4D Category A IFQ that is held by a CDQ group or transferred to a CDQ group may be fished in Area 4E by vessels less than or equal to 51 feet LOA when the commercial catch limit threshold in Area 4CDE is triggered. This final rule does not revise current regulations that authorize Category A IFQ for Areas 4B, 4C, or 4D to be fished in the corresponding area on a vessel of any length.

    Under the third limit, IFQ resulting from QS acquired after December 14, 2015, may not be transferred to a CDQ group until 3 years after the QS was acquired (i.e., the date NMFS approved the transfer). This provision effectively creates a “cooling off” period. The Council recommended and NMFS is implementing this cooling off period to reduce the incentive for individuals to acquire QS with the intention of transferring the resulting IFQ to CDQ groups rather than fishing the IFQ.

    The fourth limit prohibits an IFQ holder from transferring catcher vessel halibut IFQ for a specific IFQ regulatory area to a CDQ group for more than two consecutive years. This two-year limit applies to calendar years and only to years in which the commercial catch limit is below the threshold. Additionally, this limit applies to the transfer of any halibut IFQ for a specific area. If an IFQ holder chooses to transfer some but not all of his or her IFQ for a particular area during a year when the annual commercial catch limit for that area is set below the threshold, that transfer will count towards the two-year limit. Transfers of IFQ for one area will not affect the ability to transfer IFQ for another area. This final rule limits the potential for an IFQ holder to continuously transfer IFQ to CDQ groups rather than fishing that IFQ or transferring the underlying QS to other new entrants in the fishery.

    Under the fifth limit, only catcher vessel QS holders that hold fewer than 76,355 QS units specified for Area 4B may transfer their catcher vessel IFQ to CDQ groups. NMFS will consider all categories of Area 4B QS holdings regardless of blocked or unblocked status. This limit ensures that persons holding larger amounts of QS units continue to be active fishermen in the Area 4B halibut fishery while providing an opportunity for persons holding smaller amounts of QS units to transfer catcher vessel IFQ to CDQ groups if the 1 million pound commercial catch limit threshold to allow IFQ transfers is met. As described in the proposed rule (83 FR 8028, March 26, 2018), this limitation applies only for Area 4B to accommodate the specific nature of IFQ operations in the remote Aleutian Island communities in Area 4B.

    This final rule establishes a reporting requirement for CDQ groups that receive IFQ by transfer. The report is required only for those years in which CDQ groups received IFQ by transfer. CDQ groups that receive IFQ by transfer will be required to report the annual amount and vessel category of Area 4 halibut IFQ transferred to the CDQ group, the criteria used to select IFQ holders to transfer Area 4 halibut IFQ to the CDQ group, and the criteria used to determine the person(s) eligible to fish Area 4 halibut IFQ received by transfer. This report will allow the Council, NMFS, and the public to monitor the use of IFQ transferred to CDQ groups and provide the Council with information to determine whether the use of transferred IFQ is consistent with its intent for the action. This final rule requires the report to be submitted to NMFS and the Council no later than January 31 of the year after the IFQ was transferred to the CDQ group. This deadline is consistent with other reports required under the IFQ Program and ensures that NMFS and the Council have received the report prior to the issuance of IFQ, which typically occurs in mid-February. If a CDQ group is required to submit a report and does not do so by the deadline, the CDQ group will be ineligible to receive transfers of catcher vessel IFQ until the report is submitted.

    Under this final rule, a CDQ group that wants to receive halibut IFQ by transfer will make an arrangement with an IFQ holder to transfer his or her IFQ. The CDQ group must complete an Application for Temporary Transfer of Halibut and Sablefish IFQ and submit the application to NMFS for approval. Once approved, NMFS will issue the CDQ group an IFQ permit with the pounds of halibut IFQ that will be available to be fished. After determining who will fish the halibut IFQ, the CDQ group with the IFQ permit must apply to NMFS for a hired master permit for the vessel operator designated to fish the halibut IFQ. Current regulations authorize a vessel operator to harvest halibut IFQ and CDQ on the same fishing trip. A vessel operator harvesting both halibut CDQ and IFQ transferred to a CDQ group is required to carry (1) a halibut CDQ permit, (2) a CDQ hired master permit, (3) a copy of the IFQ permit of the CDQ group, and (4) an IFQ hired master permit. Additionally, any vessels fishing halibut IFQ transferred to a CDQ group will be subject to the current IFQ vessel use caps under § 679.42(h)(1). If a vessel harvests both halibut IFQ and CDQ, only the halibut IFQ accrues towards, and is subject to, the vessel use cap.

    Halibut that is landed by a vessel operator harvesting CDQ and IFQ will be debited off two separate catch limits. Therefore, for purposes of catch accounting, participants are required to track what amount of halibut harvest is associated with the group's CDQ and what amount is associated with the IFQ permit held by the CDQ group. This distinction must be recorded on the fish ticket (Section 3.8.11.3 of the Analysis). NMFS updated the database that monitors transfers of IFQ between permit holders and that is used to issue hired master permits to allow for this new type of transfer (see Section 3.8.11.4 of the Analysis).

    Under this final rule, CDQ groups are responsible for cost recovery fees based on the amount of IFQ pounds held on the IFQ permit. Section 304(d)(2)(A) of the Magnuson-Stevens Act obligates NMFS to recover the actual costs of management, data collection, and enforcement (direct program cost) of the IFQ fisheries. Therefore, NMFS implemented a cost recovery fee program for the IFQ fisheries in 2000 (65 FR 14919, March 20, 2000). While costs specific to the CDQ Program for halibut are recoverable through a separate cost recovery program (81 FR 150, January 5, 2016), this final rule requires regulatory changes to the IFQ transfer and hired master use provisions and therefore constitutes a change in management of the IFQ Program. CDQ group participants receiving IFQ transfers will be required to pay an IFQ cost recovery fee as a portion of the ex-vessel value of their landed halibut.

    Section 8(2) of the IPHC annual management measures (83 FR 10390, March 9, 2018) authorizes a vessel operator harvesting halibut CDQ in Areas 4D or 4E to retain halibut that are less than the size limit established by the IPHC for personal use. Under the status quo, a vessel operator harvesting halibut IFQ held by a CDQ group along with halibut CDQ may retain halibut less than legal size for personal use. Vessel operators harvesting both halibut CDQ and halibut IFQ transferred to a CDQ group in Areas 4D or 4E may retain halibut smaller in length than the size limit established by the IPHC for personal use as specified in section 8 of the IPHC annual management measures. The personal use allotment applies to all halibut IFQ transferred to a CDQ group under this exemption. Section 8(3) of the IPHC annual management measures requires a CDQ group to report on all retained halibut for personal use that are smaller than legal size and harvested on behalf of a CDQ group.

    This final rule modifies the definition of “annual commercial catch limit” at 50 CFR 300.61 to include definitions for Areas 3B and 4A, and for Areas 4B, 4C, 4D, and 4E.

    This final rule modifies § 679.41 to allow transfer of halibut IFQ in Areas 4B, 4C, and 4D in years of low halibut commercial catch limits in Areas 4B and 4CDE to CDQ groups along with the specific conditions under which this transfer activity may occur.

    This final rule adds a reporting requirement under § 679.5(l)(10) to require a CDQ group to submit a report to NMFS and the Council on the criteria it used to select IFQ holders from whom IFQ transfers were received, the criteria it used to determine the persons who could harvest transferred IFQ, and the amount and type of IFQ transferred.

    This final rule adds a provision under § 679.42 to allow Area 4D IFQ that is transferred to a CDQ group to be harvested in Area 4E.

    Anticipated Effects of Action 1

    The preamble to the proposed rule describes the anticipated effects of Action 1 on CDQ groups, CDQ residents, IFQ holders, and halibut QS holders (83 FR 8028, March 26, 2018).

    Overall, this final rule provides IFQ holders and CDQ groups with an opportunity to alleviate the adverse economic, social, and cultural impacts of extremely low levels of commercial halibut catch limits on Western Alaskan communities. This final rule could also provide distributional benefits to some processing plants, secondary service providers, and communities as a whole. This final rule could benefit halibut QS holders in Areas 4B, 4C, and 4D by permitting them to transfer their Area 4B, 4C, and 4D halibut IFQ in years of extremely low commercial catch limits. This final rule could also result in some consolidation of the number of IFQ trips, and could affect the decisions of QS holders to transfer their QS if they have the ability to transfer their IFQ to CDQ groups. The preamble of the proposed rule (83 FR 8028, March 26, 2018) and Section 3.8 of the Analysis have additional details on the anticipated effects of Action 1.

    Action 2

    This final rule removes an obsolete reference in § 679.42(a)(2)(i). Currently, this regulation provides an exception to a prohibition at § 679.42(a)(2). However, the exception refers to § 679.42(k), which was modified in 2008 by the final rule to revise regulations governing the use of commercial halibut QS and the processing of non-IFQ species when processed halibut is on board a vessel (73 FR 8822; February 15, 2008). That final rule removed paragraph (k) and re-designated § 679.42(l) as paragraph (k). NMFS inadvertently neglected to remove the cross-reference to paragraph (k) in § 679.42(a)(2)(i). Therefore, with this final rule, NMFS removes the cross-reference to paragraph (k) to clarify that persons possessing unused Category B, C, or D halibut QS may be on board a catcher/processor vessel when that vessel is harvesting and processing Category A halibut or sablefish IFQ, or is harvesting and processing non-IFQ species. The effects of this action are expected to be minor and beneficial by improving the clarity of the regulations.

    Action 3

    This final rule clarifies existing regulations pertaining to the IFQ vessel limitations, also referred to as the vessel use caps. NMFS adds language to § 679.42(h)(1) and (h)(2) to clarify that the vessel use caps apply to halibut and sablefish IFQ and not to halibut and sablefish CDQ. This action improves the clarity of the regulations and helps IFQ and CDQ participants understand the regulations to which they are subject. The effects of this action are expected to be minor and beneficial by improving the clarity of the regulations.

    Comments and Responses

    NMFS received 4 comment letters on the proposed rule. One of the comment letters was outside the scope of this action. NMFS has summarized and responded to the six unique comments in the remaining three comment letters.

    Comment 1: There should not be a transfer of halibut IFQ during years of low abundance unless they give back to others during years of high abundance. They harvest so much that they caused the low abundance.

    Response: NMFS disagrees. Based on the best available scientific information from the IPHC, halibut is not considered to be subject to overfishing as that term is defined by the IPHC (Section 3.6.1 of Analysis). As described in Section 3.6.1 of the Analysis, annual catch limits are set in a precautionary manner to achieve optimum yield on a continuing basis. As described in the proposed rule and Section 3.6.1 of the Analysis, this final rule does not increase the overall amount of halibut in Areas 4B or 4CDE that is authorized to be harvested on an annual basis. The final rule establishes a voluntary program that provides participants with an opportunity to utilize available catch to mutual benefit during times of low abundance and does not require QS holders to transfer IFQ to CDQ groups during times of low abundance or require CDQ groups to transfer IFQ back to QS holders during times of high abundance.

    Comment 2: This rule allows leasing quota when the fish populations are low and it would increase the chance of overfishing the halibut stock.

    Response: Annual halibut commercial catch limits are adjusted downward with decreasing abundance to protect the stock and prevent overfishing. This final rule does not change the process of allocating halibut among Areas or the process of establishing halibut commercial catch limits, nor will this final rule change specific management measures that govern the harvest of halibut in Areas 4B and 4CDE, such as fishing location, timing, effort, or authorized gear types. Section 3.6.1 of the Analysis describes the current status of the halibut stock which is not overfished or subject to overfishing. This final rule creates an exception to allow CDQ groups to receive IFQ by transfer, within the established annual catch limits, in years of low abundance. Therefore, this final rule will not increase the chance of overfishing of the halibut stock.

    Comment 3: It is worth pausing to remember how bad the old days were, prior to implementation of the IFQ program. In order to catch as much of the TAC as possible, the industry did not pay attention to the environmental impact of its operations, worker safety, and excessive bycatch. NOAA is right to continue to refine this outstanding program. The proposed rule to allow transfers of IFQ to CDQ groups is well-written and prevents abuse of the program by “mailbox-fishermen” and favors the coastal communities.

    Response: NMFS acknowledges this comment.

    Comment 4: If the halibut stock is low enough to trigger this flexibility, expanding flexibility will further aggravate the problem of an overfished stock. When the stock is low, then everyone should suffer, both CDQ fishermen and IFQ fishermen, in order for the stock to regenerate.

    Response: NMFS disagrees. Annual halibut commercial catch limits are set with precaution and adjusted downward in times of low abundance to avoid overfishing. The flexibility provided by this final rule will not create an overfished condition or contribute to overfishing. This final rule does not modify the methods for apportioning halibut catch limits between the CDQ and IFQ Programs. As halibut catch limits increase or decrease based on halibut abundance, participants in the CDQ and IFQ Programs are not affected any differently under this final rule than under current regulations. If the catch limit threshold is low enough to trigger the ability for QS holders to transfer their IFQ to CDQ groups, then QS holders and CDQ groups benefit from a voluntary market transaction. Disapproving this rule would not increase halibut abundance. Section 3.8 of the Analysis provides additional detail on the anticipated effects of this final rule.

    Comment 5: NMFS should consider setting lease terms for this exception because if the cost of the lease is too high, the benefits of the proposed rule would be blunted.

    Response: The Council and NMFS did not want to be involved in setting lease terms, similar to other transfer exceptions in the IFQ Program. The IFQ Program relies on market-based values and NMFS anticipates that IFQ and CDQ participants would come to a private agreement in this voluntary exception. In Section 3.8.7 of the Analysis, NMFS describes the impact that the transfer of IFQ (i.e., leasing) could have on QS markets. As described in the preamble of this final rule, there are several limitations on the transfer of IFQ. These limitations are intended, in part, to maintain current fishing business practices and to limit potential adverse impacts on a range of participants in the CDQ and IFQ Programs. This final rule does not establish additional requirements on the specific agreements between QS holders and CDQ groups when transferring IFQ because the limitations established by this final rule sufficiently constrain the amount of IFQ, the vessel category of IFQ, and the specific halibut catch limits conditions in Areas 4B and 4CDE IFQ that may be transferred.

    Comment 6: NMFS should terminate the policy to allow unused quota to carry over to the next season and instead allow unused quota to carry over to the next season only for the purposes of leasing it to CDQ groups.

    Response: This final rule does not modify existing regulations that allow a QS holder's annual IFQ allocation to be adjusted to cover under- or over-harvest from the previous year (see regulations at § 679.40(d) and (e)). The Council focused on alternatives that would allow transfer of IFQ to CDQ groups within the year of low halibut commercial catch limits, rather than adjusting over/under harvest rules that would apply to the following year when the halibut commercial catch limits may not be under the thresholds, as a more direct method of addressing the issue.

    OMB Revisions to PRA References in 15 CFR 902.1(b)

    Section 3507(c)(B)(i) of the Paperwork Reduction Act (PRA) requires that agencies inventory and display a current control number assigned by the Director of the Office of Management and Budget (OMB), for each agency's information collection. Section 902.1(b) identifies the location of NOAA regulations for which OMB approval numbers have been issued. Because this final rule adds a new collection-of-information for recordkeeping and reporting requirements, 15 CFR 902.1(b) is revised to reference correctly the section resulting from this final rule.

    Changes From the Proposed Rule

    NMFS makes two minor changes to the proposed regulatory text in this final rule. First, § 679.5(l)(10) is changed to include the words “and the Council.” New regulations at § 679.5(w) require a CDQ group to submit a report to both NMFS and the Council. Adding this language to § 679.5(l)(10) creates consistency between these sections. Second, NMFS changes “halibut IFQ” to “IFQ halibut” in § 679.42(h)(1) and “sablefish IFQ” to “IFQ sablefish” in § 679.42(h)(2). The proposed changes were intended to refer to the type of fish (IFQ halibut and IFQ sablefish defined at § 679.2) that will count towards the vessel limits prescribed by these paragraphs rather than the type of fishing rights (halibut IFQ and sablefish IFQ).

    Classification

    The NMFS Alaska Region Administrator determined that this final rule is necessary for the conservation and management of the IFQ halibut fishery off Alaska and that it is consistent with the Magnuson-Stevens Fishery Conservation and Management Act, the Halibut Act, and other applicable laws.

    Regulations governing the U.S. fisheries for Pacific halibut are developed by the IPHC, the Pacific Fishery Management Council, the Council, and the Secretary of Commerce. Section 5 of the Northern Pacific Halibut Act of 1982 (Halibut Act, 16 U.S.C. 773c) allows the Regional Council having authority for a particular geographical area to develop regulations governing the allocation and catch of halibut in U.S. Convention waters as long as those regulations are in addition to, and not in conflict with, IPHC regulations. This final rule is consistent with the Council's authority to allocate halibut catches among fishery participants in the waters in and off Alaska.

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

    The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration during the proposed rule stage that this action would not have a significant economic impact on a substantial number of small entities. The factual basis for the certification was published in the proposed rule and is not repeated here. No comments were received regarding this certification or on the economic impacts of the rule more generally. As a result, a regulatory flexibility analysis was not required, and none was prepared, pursuant to 5 U.S.C. 605.

    Collection-of-Information Requirements

    This final rule contains collection-of-information requirements subject to the PRA, which have been approved by OMB under OMB control number 0648-0764. After this final rule's effective date, OMB Control Number 0648-0764 will be merged with OMB Control Numbers 0648-0272 and 0648-0711.

    Public reporting burden is estimated to average per response: 2 hours for Application for Temporary Transfer of Halibut and Sablefish IFQ, 40 hours for the annual report, and 1 minute for electronic submission of cost recovery fees or 30 minutes for non-electronic fee submission. These estimates include the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.

    Send comments regarding these burden estimates or any other aspect of this data collection, including suggestions for reducing the burden, to NMFS (see ADDRESSES), and by email to [email protected], or fax to (202) 395-5806.

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

    List of Subjects 15 CFR Part 902

    Reporting and recordkeeping requirements.

    50 CFR Part 300

    Administrative practice and procedure, Fisheries, Fishing, Reporting and recordkeeping requirements.

    50 CFR Part 679

    Alaska, Fisheries, Reporting and recordkeeping requirements.

    Dated: October 12, 2018. Samuel D. Rauch III, Deputy Assistant Administrator for Regulatory Programs, National Marine Fisheries Service.

    For the reasons set out in the preamble, NMFS amends 15 CFR part 902 and 50 CFR parts 300 and 679 as follows:

    Title 15—Commerce and Foreign Trade PART 902—NOAA INFORMATION COLLECTION REQUIREMENTS UNDER THE PAPERWORK REDUCTION ACT: OMB CONTROL NUMBERS 1. The authority citation for part 902 continues to read as follows: Authority:

    44 U.S.C. 3501 et seq.

    2. In §  902.1, in the table in paragraph (b), under the entry “50 CFR”, add an entry in alphanumeric order for “679.5(w)” to read as follows:
    §  902.1 OMB control numbers assigned pursuant to the Paperwork Reduction Act.

    (b) * * *

    CFR part or section where the information collection requirement is
  • located
  • Current OMB control No.
  • (all numbers begin with 0648-)
  • *    *    *    *    * 50 CFR: *    *    *    *    * 679.5(w) -0272 *    *    *    *    *
    Title 50—Wildlife and Fisheries PART 300—INTERNATIONAL FISHERIES REGULATIONS 3. The authority for 50 CFR part 300, subpart E, continues to read as follows: Authority:

    16 U.S.C. 773-773k.

    4. In § 300.61, revise the definition of “Annual commercial catch limit” to read as follows:
    § 300.61 Definitions.

    Annual commercial catch limit, for purposes of commercial fishing in:

    (1) Commission regulatory areas 2C and 3A, means the annual commercial allocation minus an area-specific estimate of commercial halibut wastage.

    (2) Commission regulatory areas 3B and 4A, means the annual total allowable halibut removals by persons fishing IFQ.

    (3) Commission regulatory areas 4B, 4C, 4D, and 4E, means the annual total allowable halibut removals by persons fishing IFQ and CDQ.

    PART 679—FISHERIES OF THE EXCLUSIVE ECONOMIC ZONE OFF ALASKA 5. The authority citation for 50 CFR part 679 continues to read as follows: Authority:

    16 U.S.C. 773 et seq.; 1801 et seq.; 3631 et seq.; Pub. L. 108-447; Pub. L. 111-281.

    6. In § 679.5, add paragraphs (l)(10) and (w) to read as follows:
    § 679.5 Recordkeeping and reporting.

    (l) * * *

    (10) A report on annual IFQ regulatory areas 4B, 4C, and 4D Halibut IFQ transfer activities must be submitted to NMFS and the Council by a CDQ group as required at § 679.5(w).

    (w) Report on Area 4 halibut IFQ transfers to CDQ groups—(1) Applicability. A CDQ group that receives IFQ regulatory area 4 halibut IFQ by transfer must submit a timely and complete report on the CDQ group's annual halibut IFQ transfer activities for each calendar year that it receives IFQ regulatory area 4 halibut IFQ by transfer. A CDQ group is not required to submit a report for any calendar year in which it did not receive any IFQ regulatory area 4 halibut IFQ by transfer.

    (2) Time limits and submittal. A CDQ group must submit a complete report by January 31 of the year following a fishing year during which the CDQ group receives IFQ regulatory area 4B, 4C, or 4D halibut IFQ by transfer. The complete report must be submitted to the North Pacific Fishery Management Council, 605 West 4th Ave., Suite 306, Anchorage, AK 99501-2252, and to NMFS-Alaska Regional Administrator, P.O. Box 21668, Juneau, AK, 99802-1668.

    (3) Complete report. A complete report contains all report requirements described in paragraphs (w)(4)(i) through (w)(4)(iii) of this section.

    (4) Report requirements. A CDQ group must report the following information:

    (i) The annual amount, IFQ regulatory area, and vessel category of IFQ regulatory area 4B, 4C, and 4D halibut IFQ transferred to the CDQ group;

    (ii) The criteria used to select IFQ holders to transfer IFQ regulatory area 4B, 4C, and 4D halibut IFQ to the CDQ group; and

    (iii) The criteria used to determine the person(s) eligible to harvest IFQ regulatory area 4B, 4C, and 4D halibut IFQ received by transfer.

    7. In § 679.41, a. Add paragraph (c)(13); b. Revise paragraphs (d)(1), (g)(1), and (h)(2); and c. Add paragraph (o).

    The additions and revisions read as follows:

    § 679.41 Transfer of quota shares and IFQ.

    (c) * * *

    (13) If the person applying to receive halibut IFQ assigned to vessel categories B, C, or D in IFQ regulatory areas 4B, 4C, or 4D is a CDQ group, the following determinations are required:

    (i) The CDQ group applying to receive halibut IFQ for an IFQ regulatory area receives an annual allocation of halibut CDQ for that IFQ regulatory area pursuant to § 679.31(b)(1);

    (ii) The QS holder applying to transfer halibut IFQ to a CDQ group has not transferred any halibut IFQ assigned to vessel categories B, C, or D for that IFQ regulatory area to a CDQ group during the last two consecutive fishing years;

    (iii) If the IFQ to be transferred to a CDQ group results from QS that was transferred to the QS holder after December 14, 2015, the QS holder applying to transfer halibut IFQ to a CDQ group has held the underlying QS for that IFQ for a minimum of 3 years from the date NMFS approved the transfer;

    (iv) If the IFQ to be transferred to a CDQ group is assigned to vessel categories B, C, or D in IFQ regulatory area 4B, the QS holder applying to transfer that halibut IFQ to a CDQ group holds fewer than 76,355 halibut QS units in IFQ regulatory area 4B; and

    (v) The CDQ group applying to receive halibut IFQ has submitted a complete report if required to do so by § 679.5(w).

    (d) * * *

    (1) Application for Eligibility. All persons, except as provided in paragraphs (d)(1)(i) and (d)(1)(ii) of this section, applying to receive QS or IFQ must submit an Application for Eligibility to Receive QS/IFQ (Application for Eligibility) containing accurate information to the Regional Administrator. The Regional Administrator will not approve a transfer of IFQ or QS to a person until the Application for Eligibility for that person is approved by the Regional Administrator. The Regional Administrator shall provide an Application for Eligibility form to any person on request.

    (i) An Application for Eligibility is not required for a CQE if a complete application to become a CQE, as described in paragraph (l)(3) of this section, has been approved by the Regional Administrator on behalf of an eligible community.

    (ii) An Application for Eligibility is not required for a CDQ group.

    (g) * * *

    (1) Except as provided in paragraph (f), paragraph (g)(2), paragraph (l), paragraph (n) or paragraph (o) of this section, only persons who are IFQ crew members, or who were initially issued QS assigned to vessel categories B, C, or D, and meet the eligibility requirements in this section, may receive by transfer QS assigned to vessel categories B, C, or D, or the IFQ resulting from it.

    (h) * * *

    (2) IFQ resulting from categories B, C, or D QS may not be transferred separately from its originating QS, except as provided in paragraph (d), paragraph (f), paragraph (k), paragraph (l), paragraph (m), or paragraph (o) of this section.

    (o) Transfer of IFQ to CDQ groups. (1) A QS holder who holds fewer than 76,355 units of halibut QS in IFQ regulatory area 4B may transfer halibut IFQ assigned to vessel categories B, C, or D in IFQ regulatory area 4B to a CDQ group that receives an allocation of IFQ regulatory area 4B halibut CDQ if the annual commercial halibut catch limit, as defined in § 300.61 of this title, for Area 4B is less than 1 million pounds in that calendar year.

    (2) A QS holder in IFQ regulatory areas 4C or 4D may transfer halibut IFQ assigned to vessel categories B, C, or D in IFQ regulatory areas 4C or 4D to a CDQ group that receives an allocation of halibut CDQ in that IFQ regulatory area if the annual commercial halibut catch limit, as defined in § 300.61 of this title, for Area 4CDE is less than 1.5 million pounds in that calendar year.

    (3) A QS holder must meet the requirements in paragraph (c)(13) of this section to transfer halibut IFQ assigned to vessel categories B, C, or D in IFQ regulatory areas 4B, 4C, or 4D to a CDQ group.

    (4) A CDQ group that receives halibut IFQ by transfer may not transfer that halibut IFQ to any other person.

    8. In § 679.42, a. Revise paragraph (a)(1); b. Remove paragraph (a)(2)(i); c. Redesignate paragraphs (a)(2)(ii) through (iv) as paragraphs (a)(2)(i) through (iii); d. Add new paragraph (a)(2)(iv); and e. Revise paragraphs (h)(1) introductory text and (h)(2) introductory text.

    The revisions and additions read as follows:

    § 679.42 Limitations on use of QS and IFQ.

    (a) * * *

    (1) The QS or IFQ specified for one IFQ regulatory area must not be used in a different IFQ regulatory area, except for the following:

    (i) All or part of the QS and IFQ specified for regulatory area 4C may be harvested in either Area 4C or Area 4D.

    (ii) All or part of the halibut CDQ specified for regulatory area 4D may be harvested in either Area 4D or Area 4E.

    (iii) If a CDQ group is authorized to receive a transfer of halibut IFQ assigned to vessel categories B, C, or D in IFQ regulatory area 4D as specified in § 679.41(o) of this part, all or part of the halibut IFQ specified for regulatory area 4D that is held by or transferred to a CDQ group may be harvested in either Area 4D or Area 4E.

    (2) * * *

    (iv) Halibut IFQ assigned to vessel category B, C, or D held by a CDQ group may not be used on a vessel over 51 feet LOA, irrespective of the vessel category assigned to the IFQ.

    (h) * * *

    (1) Halibut. No vessel may be used, during any fishing year, to harvest more IFQ halibut than one-half percent of the combined total catch limits of halibut for IFQ regulatory areas 2C, 3A, 3B, 4A, 4B, 4C, 4D, and 4E, except that:

    (2) Sablefish. No vessel may be used, during any fishing year, to harvest more IFQ sablefish than one percent of the combined fixed gear TAC of sablefish for the GOA and BSAI IFQ regulatory areas, except that:

    [FR Doc. 2018-22687 Filed 10-17-18; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF THE TREASURY 17 CFR Part 420 Government Securities Act Regulations: Large Position Reporting Rules AGENCY:

    Office of the Assistant Secretary for Financial Markets, Treasury.

    ACTION:

    Final rule.

    SUMMARY:

    The Department of the Treasury (Treasury) is issuing a final rule to amend its Large Position Reporting rules (LPR Rules). These technical amendments make no substantive changes to the rules but are designed to provide Treasury with additional flexibility to specify in its notice requesting large position reports where and how reports are to be filed. Accordingly, Treasury will provide notice by issuing a public announcement and subsequently publishing the notice in the Federal Register. Treasury believes these amendments may also minimize the costs and burden on reporting entities.

    DATES:

    The amendments are effective November 17, 2018.

    ADDRESSES:

    This final rule is available at http://www.treasurydirect.gov and http://www.regulations.gov.

    FOR FURTHER INFORMATION CONTACT:

    Lori Santamorena, Kurt Eidemiller, Kevin Hawkins, or John Garrison, Department of the Treasury, Bureau of the Fiscal Service, Government Securities Regulations Staff, (202) 504-3632 or email us at [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Background A. Treasury's Large Position Reporting Rules

    The LPR Rules 1 are issued under the Government Securities Act (GSA),2 as amended, for the purposes of monitoring the impact of large positions in Treasury securities in the Treasury securities market and otherwise assisting the Securities and Exchange Commission (SEC) in enforcing the GSA.3 The LPR Rules provide an on-demand reporting system 4 that requires reports to be filed by entities that control 10 percent or more in a particular Treasury security (or securities) as of a particular date. The reports provide information on large positions in Treasury securities held by market participants and additional insight into the supply and demand dynamics in certain Treasury securities.5 This information allows Treasury to monitor the impact of concentrations of positions.6 Since the rules became effective in 1997, Treasury has conducted 16 large position report calls.

    1 78 FR 73414 December 10, 2014.

    2 Public Law 103-202, 107 Stat. 2344 (1993) [15 U.S.C. 78o-5(f)].

    3 Treasury does not believe that large positions in Treasury securities are inherently problematic and there is no presumption of manipulative or illegal intent merely because a reporting entity's position is large enough to be subject to Treasury's LPR Rules.

    4 An “on-demand” reporting system, rather than a regular, ongoing system of reporting, provides Treasury with the information necessary to understand supply and demand dynamics in the Treasury securities market, while minimizing the potential impact on the market's efficiency and liquidity and the cost to taxpayers of funding the federal debt. It also minimizes the cost and burden to those reporting entities affected by the LPR Rules.

    5 The GSA specifically provides that Treasury shall not be compelled to disclose publicly any information required to be kept or reported for large position reporting. In particular, the GSA exempts such information from disclosure under the Freedom of Information Act. See 15 U.S.C. 78o-5(f)(6).

    6 Under current rules, this information is also made available to the Federal Reserve Bank of New York (FRBNY), as Treasury's agent, and the SEC. See 15 U.S.C. 78o-5(f)(1).

    B. Who Is Subject to the LPR Rules

    Treasury's LPR Rules apply to all foreign and domestic persons and entities that control a reportable position in a Treasury security, including but not limited to: Government securities brokers and dealers; registered investment companies; registered investment advisers; custodians, including depository institutions that exercise investment discretion; hedge funds; pension funds; insurance companies; and foreign affiliates of U.S. entities. Central banks (including U.S. Federal Reserve Banks for their own account), foreign governments, and international monetary authorities may voluntarily submit large position reports when they meet or exceed a reporting threshold.

    C. The Existing Large Position Report Submission Process

    Under the current LPR Rules, reports are required to be filed by facsimile (fax) or delivered by hardcopy to FRBNY. A report is considered filed when received by FRBNY. Reporting entities typically have three and one-half business days to submit reports, and most reports are filed by fax with FRBNY. Following previous calls for large position reports, many reporting entities have commented that it is difficult to find functional fax machines and would prefer an alternate means of submission. In response to this feedback, Treasury is currently exploring alternate options for the submission of reports.

    II. Technical Amendments to the LPR Rules

    These technical amendments make no substantive changes to the LPR Rules. They are designed to provide Treasury with the flexibility to specify in its notice requesting large position reports where and how reports are to be filed. These amendments will also provide Treasury with the added flexibility to consider alternate means of submission, which may further reduce the burden on reporting entities. Treasury will provide notice of a request for reports, and how the reports are to be delivered, by issuing a public announcement and subsequently publishing the notice in the Federal Register.

    Specifically, the technical amendments replace references to “press release” with “public announcement;” provide the option for Treasury to specify in its public announcement that reports can be submitted to Treasury directly; and provide the option for Treasury to specify in its public announcement how reports are to be submitted by removing references to “facsimile” and “delivered hard copy.”

    III. Special Analyses

    Executive Orders 13563 and 12866 direct agencies to assess 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). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule is not a significant regulatory action for purposes of Executive Order 12866.

    This final rule is procedural in nature under 5 U.S.C. 553(b)(A) and therefore prior notice and comment procedures are not required. In addition, because the final rule makes no substantive change to the existing rules and imposes no additional requirements, we find under 5 U.S.C. 553(b)(B) that there is good cause that notice and public procedures are unnecessary, and that the rule can be issued in final form.

    Because no notice of proposed rulemaking is required, the provisions of the Regulatory Flexiblity Act (5 U.S.C. 601 et seq.) do not apply. These amendments reflect Treasury's continuing interest in meeting its informational needs while minimizing the cost and burden on those entities affected by the regulations.

    List of Subjects in 17 CFR Part 420

    Banks, Banking, Brokers, Government securities, Reporting and recordkeeping requirements.

    For the reasons stated in the preamble, 17 CFR part 420 is amended as follows:

    PART 420—LARGE POSITION REPORTING 1. The authority citation for part 420 continues to read as follows; Authority:

    15 U.S.C. 78o-5(f).

    2. Amend § 420.3 by revising the second sentence of paragraph (a) and revising paragrphs (h), (i), and (j) to read as follows:
    § 420.3 Reporting.

    (a) * * * Treasury will provide notice of the large position thresholds by issuing a public announcement and subsequently publishing the notice in the Federal Register. * * *

    (h) The report must be filed before noon Eastern Time on the fourth business day following issuance of a public announcement.

    (i) A report to be filed pursuant to paragraph (c) of this section will be considered filed when received by Treasury or the Federal Reserve Bank of New York according to the instructions provided in the public announcement.

    (j) A reporting entity that has filed a report pursuant to paragraph (c) of this section shall, at the request of Treasury, or the Federal Reserve Bank of New York at the direction of Treasury, timely provide any supplemental information pertaining to such report.

    Brian Smith, Deputy Assistant Secretary for Federal Finance.
    [FR Doc. 2018-22732 Filed 10-17-18; 8:45 am] BILLING CODE 4810-AS-P
    DEPARTMENT OF DEFENSE Department of the Navy 32 CFR Part 706 Certifications and Exemptions Under the International Regulations for Preventing Collisions at Sea, 1972 AGENCY:

    Department of the Navy (DoN), Department of Defense (DoD).

    ACTION:

    Final rule.

    SUMMARY:

    The Department of the Navy (DoN) is amending its certifications and exemptions under the International Regulations for Preventing Collisions at Sea, 1972 (72 COLREGS), to reflect that the Deputy Assistant Judge Advocate General (DAJAG) (Admiralty and Maritime Law) has determined that USS BILLINGS (LCS 15) is a vessel of the Navy which, due to its special construction and purpose, cannot fully comply with certain provisions of the 72 COLREGS without interfering with its special function as a naval ship. The intended effect of this rule is to warn mariners in waters where 72 COLREGS apply.

    DATES:

    This rule is effective October 18, 2018 and is applicable beginning October 5, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Lieutenant Commander Kyle Fralick, JAGC, U.S. Navy, Admiralty Attorney, (Admiralty and Maritime Law), Office of the Judge Advocate General, Department of the Navy, 1322 Patterson Ave. SE, Suite 3000, Washington Navy Yard, DC 20374-5066, telephone number: 202-685-5040.

    SUPPLEMENTARY INFORMATION:

    Pursuant to the authority granted in 33 U.S.C. 1605, the DoN amends 32 CFR part 706.

    This amendment provides notice that the DAJAG (Admiralty and Maritime Law), under authority delegated by the Secretary of the Navy, has certified that USS BILLINGS (LCS 15) is a vessel of the Navy which, due to its special construction and purpose, cannot fully comply with the following specific provisions of 72 COLREGS without interfering with its special function as a naval ship: Annex I paragraph 2 (a)(i), pertaining to the height of the forward masthead light above the hull: And Annex I paragraph 3(a), pertaining to the location of the forward masthead light in the forward quarter of the ship, and the horizontal distance between the forward and after masthead light. The DAJAG (Admiralty and Maritime Law) has also certified that the lights involved are located in closest possible compliance with the applicable 72 COLREGS requirements.

    Moreover, it has been determined, in accordance with 32 CFR parts 296 and 701, that publication of this amendment for public comment prior to adoption is impracticable, unnecessary, and contrary to public interest since it is based on technical findings that the placement of lights on this vessel in a manner differently from that prescribed herein will adversely affect the vessel's ability to perform its military functions.

    List of Subjects in 32 CFR Part 706

    Marine safety, Navigation (water).

    For the reasons set forth in the preamble, the DoN amends part 706 of title 32 of the Code of Federal Regulations as follows:

    PART 706—CERTIFICATIONS AND EXEMPTIONS UNDER THE INTERNATIONAL REGULATIONS FOR PREVENTING COLLISIONS AT SEA, 1972 1. The authority citation for part 706 continues to read as follows: Authority:

    33 U.S.C. 1605.

    2. Section 706.2 is amended by: a. In Table One, adding, in alpha numerical order, by vessel number, an entry for USS BILLINGS (LCS 15); and b. In Table Five, adding, in alpha numerical order, by vessel number, an entry for USS BILLINGS (LCS 15).

    The additions read as follows:

    § 706.2 Certifications of the Secretary of the Navy under Executive Order 11964 and 33 U.S.C. 1605. Table One Vessel No. Distance in
  • meters of
  • forward
  • masthead
  • light below
  • minimum
  • required
  • height
  • § 2(a)(i)
  • annex I
  • *         *         *         *         *         *         * USS BILLINGS (LCS 15) 5.9 *         *         *         *         *         *         *
    Table Five Vessel No. Masthead
  • lights not
  • over all
  • other lights and obstructions
  • annex I,
  • sec. 2(f)
  • Forward
  • masthead
  • light not in
  • forward
  • quarter of
  • ship
  • annex I,
  • sec. 3(a)
  • After
  • mast-head light
  • less than 1/2
  • ship's length
  • aft of forward
  • masthead light
  • annex I,
  • sec. 3(a)
  • Percentage
  • horizontal
  • separation
  • attained
  • *         *         *         *         *         *         * USS BILLINGS (LCS 15) X X 23 *         *         *         *         *         *         *
    Approved: October 15, 2018. A.S. Janin, Captain, JAGC, U.S. Navy, Deputy Assistant Judge Advocate, General (Admiralty and Maritime Law). Dated: October 15, 2018. Meredith Steingold Werner, Lieutenant Commander, Judge Advocate General's Corps, U.S. Navy, Federal Register Liaison Officer.
    [FR Doc. 2018-22730 Filed 10-17-18; 8:45 am] BILLING CODE 3810-FF-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 100 [Docket Number USCG-2018-0869] RIN 1625-AA08 Special Local Regulation; San Diego Bay, San Diego, CA AGENCY:

    Coast Guard, DHS.

    ACTION:

    Temporary final rule.

    SUMMARY:

    The Coast Guard is establishing a temporary special local regulation for navigable waters of the San Diego Bay offshore of Harbor Island bound landward of a line by the following coordinates starting west at 32°43.033′ N and 117°12.792′ W and proceeding east to 32°43.166′ N and 117°12.266′ W, proceeding east to 32°43.166′ N and 117°11.633′ W, and ending at 32°43.100′ N and 117°11.300′ W. This special local regulation is necessary to provide for the safety of life on navigable waters during the event. This action will restrict vessel traffic in these waters of the San Diego Bay, from 10:00 a.m. to 6:00 p.m. on October 17, 2018 through October 21, 2018.

    DATES:

    This rule is effective without actual notice from October 18, 2018 until October 21, 2018. For the purposes of enforcement from 10 a.m. to 6 p.m. daily, actual notice will be used from 10 a.m. on October 17, 2018 until October 18, 2018.

    ADDRESSES:

    To view documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov, type USCG-2018-0869 in the “SEARCH” box and click “SEARCH.” Click on Open Docket Folder on the line associated with this rule.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions on this rule, call or email Lieutenant Junior Grade Briana Biagas, Waterways Management, U.S. Coast Guard Sector San Diego, Coast Guard; telephone 619-278-7656, email [email protected]

    SUPPLEMENTARY INFORMATION:

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

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

    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register. This rule is necessary for the safety of life during the event on these navigable waters. For the reasons above, including the timing of the event, it would be impracticable to delay this rule to provide a full 30 days' notice.

    III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 33 U.S.C. 1233, which authorizes the Coast Guard to establish and define special local regulations. The COTP San Diego is establishing a special local regulation for the waters of the San Diego Bay bound landward of a line by coordinates starting west at 32°43.033′ N and 117°12.792′ W and proceeding east to 32°43.166′ N and 117°12.266′ W, proceeding east to 32°43.166′ N and 117°11.633′ W, and ending at 32°43.100′ N and 117°11.300′ W. The purpose of this rule is to ensure safety of participants, vessels and the navigable waters in the regulated area before, during, and after the scheduled event.

    IV. Discussion of the Rule

    This rule establishes a special local regulation from 10:00 a.m. to 6:00 p.m. on October 17, 2018 through October 21, 2018. The special local regulation will cover all navigable waters of the San Diego Bay bound landward of a line by coordinates starting west at 32°43.033′ N and 117°12.792′ W and proceeding east to 32°43.166′ N and 117°12.266′ W, proceeding east to 32°43.166′ N and 117°11.633′ W, and ending at 32°43.100′ N and 117°11.300′ W. The purpose of this rule is to ensure safety of participants, vessels and the navigable waters in the regulated area before, during, and after the scheduled event. Persons and vessels will be prohibited from anchoring, blocking, loitering, or impeding within this regulated waterway unless authorized by the COTP, or his designated representative, during the specified dates and times. Additionally, movement of all vessels within the regulated area and entry of all vessels into the regulated area will be restricted. The Coast Guard will publish information on the event in the weekly LNM.

    V. Regulatory Analyses

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

    A. Regulatory Planning and Review

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

    This regulatory action determination is based on size, location, duration, and time-of-day of the special local regulation. The Coast Guard will publish a LNM that details the vessel restrictions of the regulated area.

    B. Impact on Small Entities

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

    This rule will affect the following entities, some of which may be small entities: The owners or operators of vessels intending to transit or anchor in the impacted portion of the San Diego Bay bound landward of a line by coordinates starting west at 32°43.033′ N and 117°12.792′ W and proceeding east to 32°43.166′ N and 117°12.266′ W, proceeding east to 32°43.166′ N and 117°11.633′ W, and ending at 32°43.100′ N and 117°11.300′ W from 10:00 a.m. to 6:00 p.m. on October 17, 2018 through October 21, 2018.

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

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

    C. Collection of Information

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

    D. Federalism and Indian Tribal Governments

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

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

    E. Unfunded Mandates Reform Act

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

    F. Environment

    We have analyzed this rule under Department of Homeland Security Directive 023-01 and Commandant Instruction M16475.1D, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves establishment of marine event special local regulations on a portion of the navigable waters of the San Diego Bay. It is categorically excluded from further review under paragraph L61 and L63(b) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A Record of Environmental Consideration supporting this determination is available in the docket where indicated under ADDRESSES.

    G. Protest Activities

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

    List of Subjects in 33 CFR Part 100

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

    For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 100 as follows:

    PART 100—SAFETY OF LIFE ON NAVIGABLE WATERS 1. The authority citation for part 100 continues to read as follows: Authority:

    33 U.S.C. 1233; 33 CFR 1.05-1.

    2. Add § 100.35T11-0869 to read as follows:
    § 100.35T11-0869 Special Local Regulation for Marine Event; San Diego Bay, San Diego, CA.

    (a) Regulated area. The following location is a regulated area: All navigable waters of San Diego Bay bound landward of a line by coordinates starting west at 32°43.033′ N and 117°12.792′ W and proceeding east to 32°43.166′ N and 117°12.266′ W, proceeding east to 32°43.166′ N and 117°11.633′ W, and ending at 32°43.100′ N and 117°11.300′ W.

    (b) Definitions. The term “designated representative” means Coast Guard Patrol Commanders, including Coast Guard coxswains, petty officers, and other officers operating Coast Guard vessels, and Federal, state, and local officers designated by or assisting the Captain of the Port San Diego in the enforcement of the regulated areas.

    (c) Special local regulations. (1) Persons and vessels will be prohibited from anchoring, blocking, loitering, or impeding within this regulated waterway unless authorized by the COTP, or his designated representative, during the dates and times listed in paragraph (d) of this section.

    (2) Movement of all vessels within the regulated area and entry of all vessels into the regulated area will be restricted.

    (3) To seek permission to enter the regulated area, contact the Captain of the Port (COTP) San Diego or the COTP's designated representative.

    (4) The Coast Guard will publish a notice in the Eleventh Coast Guard District Local Notice to Mariners and issue a Safety Marine Information Broadcast of VHF-FM marine band radio announcing specific event location, dates and times.

    (d) Enforcement period(s). Daily from 10:00 a.m. to 6:00 p.m. on October 17, 2018 through October 21, 2018.

    Dated: October 2, 2018. J.R. Buzzella, Captain, U.S. Coast Guard, Captain of the Port San Diego.
    [FR Doc. 2018-22736 Filed 10-17-18; 8:45 am] BILLING CODE 9110-04-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [WV106-6044; FRL-9983-55-Region 3] Approval and Promulgation of Air Quality Implementation Plans; West Virginia; Update to Materials Incorporated by Reference AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Final rule; administrative change.

    SUMMARY:

    The Environmental Protection Agency (EPA) is updating the materials that are incorporated by reference (IBR) into the West Virginia state implementation plan (SIP). The regulations affected by this update have been previously submitted by the West Virginia Department of Environmental Protection (WV DEP) and approved by EPA. This update affects the SIP materials that are available for public inspection at the National Archives and Records Administration (NARA) and the EPA Regional Office.

    DATES:

    This action is effective October 18, 2018.

    ADDRESSES:

    SIP materials which are incorporated by reference into 40 CFR part 52 are available for inspection at the following locations: Air Protection Division, U.S. Environmental Protection Agency, Region III, 1650 Arch Street, Philadelphia, Pennsylvania 19103; and the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. EPA requests that you email the contact listed in the FOR FURTHER INFORMATION CONTACT section.

    FOR FURTHER INFORMATION CONTACT:

    Erin Trouba, (215) 814-2023 or by email at [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Background

    Each state has a SIP containing the control measures and strategies used to attain and maintain the national ambient air quality standards (NAAQS). The SIP is extensive, containing such elements as air pollution control regulations, emission inventories, monitoring networks, attainment demonstrations, and enforcement mechanisms.

    Each state must formally adopt the control measures and strategies in the SIP after the public has had an opportunity to comment on them and then submit the proposed SIP revisions to EPA. Once these control measures and strategies are approved by EPA, and after notice and comment, they are incorporated into the federally-approved SIP and are identified in part 52 “Approval and Promulgation of Implementation Plans,” title 40 of the Code of Federal Regulations (40 CFR part 52). The full text of the state regulation approved by EPA is not reproduced in its entirety in 40 CFR part 52, but is “incorporated by reference.” This means that EPA has approved a given state regulation with a specific effective date. The public is referred to the location of the full text version should they want to know which measures are contained in a given SIP. The information provided allows EPA and the public to monitor the extent to which a state implements a SIP to attain and maintain the NAAQS and to take enforcement action if necessary.

    The SIP is a living document which a state revises as necessary to address its unique air pollution problems. Therefore, EPA, from time to time, must take action on SIP revisions containing new and/or revised regulations as being part of the SIP. On May 22, 1997 (62 FR 27968), EPA revised the procedures for incorporating by reference federally-approved SIPs, as a result of consultations between EPA and the Office of the Federal Register (OFR). The description of the revised SIP document, IBR procedures and “Identification of plan” format are discussed in further detail in the May 22, 1997, Federal Register document. On February 10, 2005 (70 FR 7024), EPA published a Federal Register beginning the new IBR procedure for West Virginia. On February 28, 2007 (72 FR 8903), February 10, 2009 (74 FR 6542), December 28, 2010 (75 FR 81474), July 25, 2013 (78 FR 44884), and June 14, 2017 (82 FR 27118) EPA published updates to the IBR material for West Virginia. Since the publication of the last IBR update, EPA has approved into the SIP the following regulatory changes to the following West Virginia regulations:

    A. Added Regulations

    None.

    B. Revised Regulations 1. 45 CSR 8 (Ambient Air Quality Standards) 2. 45 CSR 14 (Permits for Construction and Major Modification of Major Stationary Sources of Air Pollution for the Prevention of Significant Deterioration) C. Removed Regulations 1. 45 CSR 39 (Control of Annual Nitrogen Oxide Emissions to Mitigate Interstate Transport of Fine Particulate Matter and Nitrogen Oxides) 2. 45 CSR 41 (Control of Annual Sulfur Dioxides Emissions) 3. In 52.2520 paragraph (d) Source Specific Requirements for West Virginia, there was a removal of source-specific SIP requirements for the following five facilities in West Virginia that had permanently shutdown: Mountaineer Carbon Company; Standard Lafarge; Follansbee Steel Corporation; International Mill Service, Inc.; and Columbian Chemicals Company. II. EPA Action

    In this action, EPA is announcing the update to the IBR material as of May 1, 2018 and revising the text within 40 CFR 52.2520(b). In addition, notice is provided of correcting Federal Register citations listed in the Table (c) paragraph of 40 CFR 52.2520, as described: A. Under the “EPA approval date” EPA is correcting numerous Federal Register citation locations to reflect the first page of the preamble opposed to the regulatory text page for West Virginia regulations 45 CSR Series 8 and 45 CSR Series 14.

    III. Good Cause Exemption

    EPA has determined that this rule falls under the “good cause” exemption in section 553(b)(3)(B) of the Administrative Procedures Act (APA) which, upon finding “good cause,” authorizes agencies to dispense with public participation and section 553(d)(3) which allows an agency to make a rule effective immediately (thereby avoiding the 30-day delayed effective date otherwise provided for in the APA). This rule simply codifies provisions which are already in effect as a matter of law in federal and approved state programs. Under section 553 of the APA, an agency may find good cause where procedures are “impractical, unnecessary, or contrary to the public interest.” Public comment is “unnecessary” and “contrary to the public interest” since the codification only reflects existing law. Immediate notice in the CFR benefits the public by removing outdated citations and incorrect table entries.

    IV. Incorporation by Reference

    In this rule, EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is finalizing the incorporation by reference of previously EPA approved regulations promulgated by the State of West Virginia and federally effective prior to May 1, 2018. EPA has made, and will continue to make, these materials generally available through www.regulations.gov and at the EPA Region III Office (please contact the person identified in the For Further Information Contact section of this preamble for more information).

    V. Statutory and Executive Order Reviews A. General Requirements

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

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

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

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

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

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

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

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

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

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

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

    In addition, this rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in the state, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law.

    B. Submission to Congress and the Comptroller General

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

    C. Petitions for Judicial Review

    EPA has also determined that the provisions of section 307(b)(1) of the CAA pertaining to petitions for judicial review are not applicable to this action. Prior EPA rulemaking actions for each individual component of the West Virginia SIP compilations had previously afforded interested parties the opportunity to file a petition for judicial review in the United States Court of Appeals for the appropriate circuit within 60 days of such rulemaking action. Thus, EPA sees no need in this action to reopen the 60-day period for filing such petitions for judicial review for this “Identification of plan” update action for West Virginia.

    List of Subjects in 40 CFR Part 52

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

    Dated: August 27, 2018. Cecil Rodrigues, Acting Regional Administrator, Region III.

    40 CFR part 52 is amended as follows:

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

    42 U.S.C. 7401 et seq.

    Subpart XX—West Virginia 2. Section 52.2520 is amended by: a. Revising paragraph (b). b. Revising paragraph (c) table entries for 45 CSR 8 (Ambient Air Quality Standards) and 45 CSR 14 (Permits for Construction and Major Modification of Major Stationary Sources of Air Pollution for the Prevention of Significant Deterioration).

    The revisions read as follows:

    § 52.2520 Identification of plan.

    (b) Incorporation by reference. (1) Material listed in paragraphs (c) and (d) of this section with an EPA approval date prior to May 1, 2018, was approved for incorporation by reference by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Entries in paragraphs (c) and (d) of this section with the EPA approval dates after May 1, 2018 for the State of West Virginia have been approved by EPA for inclusion in the State implementation plan and for incorporation by reference into the plan as it is contained in this section, and will be considered by the Director of the Federal Register for approval in the next update to the SIP compilation.

    (2) EPA Region III certifies that the materials provided by EPA at the addresses in paragraph (b)(3) of this section are an exact duplicate of the officially promulgated state rules/regulations which have been approved as part of the state implementation plan as of the dates referenced in paragraph (b)(1) of this section.

    (3) Copies of the materials incorporated by reference into the state implementation plan may be inspected at the Environmental Protection Agency, Region III, 1650 Arch Street, Philadelphia, Pennsylvania 19103. To obtain the material, please call the Regional Office at (215) 814-3376. You may also inspect the material with an EPA approval date prior to May 1, 2018 for the State of West Virginia at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    (c) EPA-Approved Regulations and Statutes.

    EPA-Approved Regulations in the West Virginia SIP State citation
  • [Chapter 16-20 or 45 CSR]
  • Title/subject State effective date EPA approval date Additional explanation/
  • citation at 40 CFR 52.2565
  • *         *         *         *         *         *         * [45 CSR] Series 8 Ambient Air Quality Standards Section 45-8-1 General 6/1/17 3/23/18, 83 FR 12677 Filing and effective dates are revised. Section 45-8-2 Definitions 6/1/17 3/23/18, 83 FR 12677 Previous Approval 9/22/2014. Section 45-8-3 Adoption of Standards 6/1/17 3/23/18, 83 FR 12677 Effective date is revised. Section 45-8-4 Inconsistency Between Rules 6/1/17 3/23/18, 83 FR 12677 Replaced “West Virginia Department of Environmental Protection” with “Division of Air Quality.” *         *         *         *         *         *         * [45 CSR] Series 14 Permits for Construction and Major Modification of Major Stationary Sources of Air Pollution for the Prevention of
  • Significant Deterioration
  • Section 45-14-1 General 06/01/2015 08/11/2016, 81 FR 53008 Section 45-14-2 Definitions 06/01/2015 08/11/2016, 81 FR 53008 Section 45-14-3 Applicability 06/01/2015 08/11/2016, 81 FR 53008 Section 45-14-4 Ambient Air Quality Increments and Ceilings 06/01/2015 08/11/2016, 81 FR 53008 Section 45-14-5 Area Classification 06/01/2015 08/11/2016, 81 FR 53008 Section 45-14-6 Prohibition of Dispersion Enhancement Techniques 06/01/2015 08/11/2016, 81 FR 53008 Section 45-14-7 Registration, Report and Permit Requirements for Major Stationary Sources and Major Modifications 06/01/2015 08/11/2016, 81 FR 53008 Section 45-14-8 Requirements Relating to Control Technology 06/01/2015 08/11/2016, 81 FR 53008 Section 45-14-9 Requirements Relating to the Source's Impact on Air Quality 06/01/2015 08/11/2016, 81 FR 53008 Section 45-14-10 Modeling Requirements 06/01/2015 08/11/2016, 81 FR 53008 Section 45-14-11 Air Quality Monitoring Requirements 06/01/2015 08/11/2016, 81 FR 53008 Section 45-14-12 Additional Impacts Analysis Requirements 06/01/2015 08/11/2016, 81 FR 53008 Section 45-14-13 Additional Requirements and Variances for Source Impacting Federal Class 1 Areas 06/01/2015 08/11/2016, 81 FR 53008 Section 45-14-14 Procedures for Sources Employing Innovative Control Technology 06/01/2015 08/11/2016, 81 FR 53008 Section 45-14-15 Exclusions From Increment Consumption 06/01/2015 08/11/2016, 81 FR 53008 Section 45-14-16 Specific Exemptions 06/01/2015 08/11/2016, 81 FR 53008 Section 45-14-17 Public Review Procedures 06/01/2015 08/11/2016, 81 FR 53008 Section 45-14-18 Public Meetings 06/01/2015 08/11/2016, 81 FR 53008 Section 45-14-19 Permit Transfer, Cancellation and Responsibility 06/01/2015 08/11/2016, 81 FR 53008 Section 45-14-20 Disposition of Permits 06/01/2015 08/11/2016, 81 FR 53008 Section 45-14-21 Conflict with Other Permitting Rules 06/01/2015 08/11/2016, 81 FR 53008 Section 45-14-25 Actual PALs 06/01/2015 08/11/2016, 81 FR 53008 Section 45-14-26 Inconsistency Between Rules 06/01/2015 08/11/2016,81 FR 53008 *         *         *         *         *         *         *
    [FR Doc. 2018-22653 Filed 10-17-18; 8:45 am] BILLING CODE 6560-50-P
    DEPARTMENT OF THE INTERIOR Fish and Wildlife Service 50 CFR Part 17 [Docket No. FWS-R6-ES-2016-0013; FXES11130900000C6-189-FF09E42000] RIN 1018-BB41 Endangered and Threatened Wildlife and Plants; Removing Deseret Milkvetch (Astragalus desereticus) From the Federal List of Endangered and Threatened Plants AGENCY:

    Fish and Wildlife Service, Interior.

    ACTION:

    Final rule; document availability.

    SUMMARY:

    We, the U.S. Fish and Wildlife Service (Service), are removing Deseret milkvetch (Astragalus desereticus) from the Federal List of Endangered and Threatened Plants due to recovery. Based on the best available scientific and commercial data, threats to Deseret milkvetch identified at the time of listing are not as significant as originally anticipated and are being adequately managed, the species' population is much greater than was known at the time of listing, and threats to this species have been sufficiently minimized such that it no longer meets the definition of an endangered species or threatened species under the Endangered Species Act of 1973, as amended (Act).

    DATES:

    This final rule is effective November 19, 2018.

    ADDRESSES:

    Comments, materials received and supporting documentation used in the preparation of this final rule are available on the internet at http://www.regulations.gov under Docket No. FWS-R6-ES-2016-0013. Additionally, comments, materials received, and supporting documentation are available for public inspection by appointment at our Utah Ecological Services Field Office (see FOR FURTHER INFORMATION CONTACT, below). The post-delisting monitoring plan for Deseret milkvetch is available on our Endangered Species Program's national website (http://endangered.fws.gov) and the internet at http://www.regulations.gov under Docket No. FWS-R6-ES-2016-0013.

    FOR FURTHER INFORMATION CONTACT:

    Larry Crist, Field Supervisor, telephone: 801-975-3330. Direct all questions or requests for additional information to: DESERET MILKVETCH QUESTIONS, U.S. Fish and Wildlife Service; Utah Ecological Services Field Office; 2369 Orton Circle, Suite 50; West Valley City, UT 84119. If you use a telecommunications device for the deaf (TDD), you may call the Federal Relay Service at 800-877-8339.

    SUPPLEMENTARY INFORMATION: Previous Federal Actions

    On October 2, 2017, we published a proposed rule to remove Deseret milkvetch from the List of Endangered and Threatened Plants (i.e., to “delist” the species) (82 FR 45779). Please refer to that proposed rule for a detailed description of the Federal actions concerning this species that occurred prior to October 2, 2017.

    Species Description and Habitat Information

    Deseret milkvetch was first collected in 1893, again in 1909, then not located again until 1981 (Barnaby 1989, p. 126; Franklin 1990, p. 2). The gap in collections may be due to confusion regarding initial records, which were wrongly attributed to Sanpete County, Utah (Franklin 1990, p. 2). The 1964 description and classification of Deseret milkvetch by Barneby is the accepted taxonomic status (Barneby 1989, p. 126; ITIS 2015).

    Deseret milkvetch is a perennial, herbaceous plant in the legume family with silvery-gray pubescent leaves that are 2 to 5 inches (4 to 12 centimeters) long and flower petals that are white to pinkish with lilac-colored tips (Barneby 1989, p. 126). The flower structure indicates an adaptation to pollination primarily by large bees, likely bumblebees (Bombus spp.), which are generalist pollinators (Stone 1992, p. 4). The species appears to be tolerant of drought (Stone 1992, p. 3). A more detailed description of the biology and life history of Deseret milkvetch can be found in our 5-year review of the species (U.S. Fish and Wildlife Service 2011, pp. 5-7).

    Deseret milkvetch is endemic to Utah County in central Utah, with the only known population near the town of Birdseye (Stone 1992, p. 2). It occurs exclusively on sandy-gravelly soils weathered from the Moroni geological formation, which are limited to an area of approximately 100 square miles (mi2) (259 square kilometers (km2)) (Franklin 1990, p. 4; Stone 1992, p. 3). The species is known to occur at elevations of 5,400 to 5,700 feet (ft) (1,646 to 1,737 meters (m)) (Stone 1992, p. 2; Anderson 2016, pers. comm.; Fitts 2016, pers. comm.). Based upon the species' narrow habitat requirements, it has likely always been rare, with little unoccupied suitable habitat (Franklin 1990, p. 6; Stone 1992, p. 6).

    Deseret milkvetch is found on steep south- and west-facing slopes with scattered Colorado pinyon pine (Pinus edulis) and Utah juniper (Juniperus osteosperma) (Franklin 1990, p. 2). It also grows on west-facing road-cuts where plants are typically larger than those found in undisturbed habitat (Franklin 1990, p. 2). The species' habitat is sparsely vegetated (SWCA Environmental Consultants 2015, p. 7). The species is an associate of the pinyon-juniper plant community. It is not shade-tolerant but is found in open areas between trees (Goodrich et al. 1999, p. 265).

    Deseret milkvetch is probably a relatively new species on the scale of geologic time. The species' genus has the ability to colonize disturbed or unstable habitats in dry climates. This ability has likely hastened the evolution of the genus and given rise to many species of Astragalus that are sharply differentiated and individually geographically restricted (Stone 1992, p. 6). Deseret milkvetch tolerates at least some degree of disturbance, such as that caused by road maintenance activities (Franklin 1990, p. 2; Fitts and Fitts 2009, p. 5).

    Species Abundance, Distribution, and Trends

    In 1990, surveys for Deseret milkvetch estimated fewer than 5,000 plants in a single population (Franklin 1990, p. 3). A subsequent survey at the same site in 1992 estimated more than 10,000 plants, indicating that a large seed bank likely exists (Stone 1992, p. 7). Consequently, at the time of listing, we estimated a total population of 5,000 to 10,000 plants (64 FR 56590, October 20, 1999).

    In 2008, the Utah Natural Heritage Program surveyed suitable habitats and provided a total population estimate for the species (Fitts 2008, p. 1). The surveyors found new plant sites (hereafter referred to as a colony) to the north and west of the previously known population. The total population estimate was 152,229 plants--including seedlings, juveniles, and adults (Fitts and Fitts 2009, p. 4), well above the number of plants known to occur in 1990. If only adults were counted in the 2008 survey, the population estimate was 86,775 to 98,818 plants (U.S. Fish and Wildlife Service 2011, p. 10). The species remains known from a single population, with multiple colonies.

    In 2009, surveys were expanded, and the updated total population estimate was 197,277 to 211,915 juvenile and adult plants (Fitts and Fitts 2010, p. 6); however, the survey methodology in this year was not clearly described. More plants likely occurred on nearby private land with exposed Moroni Formation outcrops, but the landowner did not give permission to survey (Fitts and Fitts 2010, p. 7). These surveys may have overestimated the species' population using the partial census method due to extrapolation from earlier hand-drawn colony boundaries; the small number of transects; and the inclusion of seedlings, which have a high rate of mortality (U.S. Fish and Wildlife Service 2011, p. 10).

    In 2016, partial surveys were conducted showing dense levels of occupancy in the northmost portion of the range, in areas that were known to be occupied but had not been previously surveyed (Fitts 2018, pers. comm.). In 2017, surveys of all accessible habitats were conducted in accordance with the protocol used in 2008, resulting in a population estimate of 88,427 (adults and juveniles) in the population total, with 50,483 on State lands (UNHP 2018, p. 4-5). Surveys in 2017 did not include private lands, and so we estimated the total population by applying known densities of adjacent State lands to the private land acreages (UNHP 2018, entire).

    The 2017 population estimates represent a reduction in population from the surveys conducted in 2008 and 2009 but are still well above the number of plants known in 1990. We believe the reduction in numbers from 2009 to 2017 is consistent with what we know about the species' response to drought conditions. In 2015 and 2016, the habitat experienced moderate to severe drought conditions (National Drought Resilience Partnership 2018, entire). In late 2016 and early 2017, the habitat received above-average precipitation levels, and the lower overall population coupled with the increased proportion of juvenile plants recorded in spring of 2017 would be consistent with a response to two seasons of drought followed by increased precipitation in the preceding fall causing a germination event. The proportion of juvenile plants increased from 15 percent in 2008 to 44 percent in 2017 (USFWS 2011, p. 10; UNHP 2018, p. 4). We believe this represents a natural response cycle to annual precipitation patterns and not a declining trend caused by anthropogenic stressors. Additionally, the consistent presence of seedlings and juveniles in the 2008, 2009, 2016, and 2017 surveys indicates that recruitment occurs regularly and a robust seedbank exists. Although 2018 survey results are not yet available, we expect they will be reflective of the low precipitation level in 2018.

    At the time of listing, we estimated the occupied habitat of Deseret milkvetch to include approximately 300 acres (ac) (122 hectares (ha)) in an area 1.6 miles (mi) (2.6 kilometers (km)) by 0.3 mi (0.5 km) (64 FR 56590; October 20, 1999). The most recent occupied habitat estimate is approximately 345 ac (140 ha) in an area 2.8 mi (4.5 km) by 0.3 mi (0.5 km) (Fitts and Fitts 2010, p. 6; SWCA Environmental Consultants 2015, p. 2). The species remains known from one population (Birdseye) of scattered colonies on the Moroni formation soils near Birdseye, Utah (U.S. Fish and Wildlife Service 2011, p. 8).

    In summary, periodic surveys of Deseret milkvetch were completed from 1990 through 2017. The available information indicates a substantial population increase since 1990 when the first surveys were conducted (from an estimated 5,000-10,000 plants in 1999 to an estimated 88,000 plants in 2017). Population and demographic fluctuations between 2008 and 2017 are likely a natural part of this species' lifecycle that is related to precipitation. While the exact distribution of colonies has shifted over time, there has been no overall reduction in the area occupied since the time of listing and additional colonies have been located (UNHP 2018, p. 3). Therefore, we conclude that the population has been stable to increasing overall since the time of listing.

    Land Ownership

    An estimated 230 ac (93 ha; 67 percent) of the 345 ac (140 ha) of total occupied habitat for Deseret milkvetch are in the Birdseye Unit of the Northwest Manti Wildlife Management Area (WMA) owned by the Utah Division of Wildlife Resources (UDWR). Of the remaining habitat, 25 ac (10 ha; 7 percent) are owned by the Utah Department of Transportation (UDOT) and 90 ac (36 ha; 26 percent) are privately owned (UDWR et al. 2006, p. 4). The Utah School and Institutional Trust Lands Administration (SITLA) owns most of the mineral rights in the species' habitat (UDWR et al. 2006, p. 7). No populations of Deseret milkvetch are known to occur on Federal lands (Franklin 1990, pp. 3-4; Anderson 2016, pers. comm.).

    Conservation Efforts

    A recovery plan for Deseret milkvetch was not prepared; therefore, specific delisting criteria were not developed for the species. However, in 2005, we invited agencies with management or ownership authorities within the species' habitat to serve on a team to develop an interagency conservation agreement for Deseret milkvetch intended to facilitate a coordinated conservation effort between the agencies (UDWR et al. 2006, entire). The Conservation Agreement for Astragalus desereticus (Deseret milkvetch) (Conservation Agreement) was signed and approved by UDWR, UDOT, SITLA, and the Service in 2006, with a duration of 30 years. The Conservation Agreement provides guidance to stakeholders to address threats and establish goals to ensure the long-term survival of the species (UDWR et al. 2006, p. 7). Conservation actions identified in the Conservation Agreement (in italics), their current status, and efforts to accomplish these actions are described below.

    Maintain species' habitat within the WMA in its natural state, restricting habitat disturbance: This action is successful and ongoing. UDWR acquired the Birdseye Unit of the Northwest Manti WMA in 1967. Prior to this acquisition, livestock grazing occurred for more than 50 years on the property (UDWR et al. 2006, p. 6). Since the acquisition, livestock grazing has been used only on a limited basis as a management tool by UDWR. However, habitat occupied by Deseret milkvetch is not suitable for grazing, and impacts to the species from grazing have been negligible (UDWR et al. 2006, p. 7). This habitat has not been grazed by livestock since 2002 (U.S. Fish and Wildlife 2011, p. 17). Future grazing within the occupied habitat is unlikely due to the steep terrain (Howard 2016, pers. comm.).

    A draft wildlife management plan completed by UDWR proposes closing some unauthorized, unpaved roads within the WMA, which likely would further benefit the species by reducing habitat fragmentation and reducing future human access to the population (Howard 2018, pers. comm.). We anticipate that the plan will be finalized within the next year (Howard 2018, pers. comm.). Because this plan is currently only in draft, we do not rely on it in this final rule to delist the species. However, it provides an indication of future management intentions of UDWR to the continuing benefit of the species from the ongoing management of the WMA.

    Removal of juniper in the WMA to improve habitat may occur, but areas occupied by Deseret milkvetch will be avoided to prevent plant damage and mortality associated with this type of surface-disturbing activity (Howard 2018, pers. comm.). The steep terrain associated with Deseret milkvetch makes grazing, juniper removal, and livestock grazing in the species' occupied habitat unlikely.

    Retain species' habitat within the WMA under the management of UDWR: This action is successful and ongoing. The UDWR continues to manage the species' habitat within the WMA in its natural state with minimal disturbance, as stipulated in the Conservation Agreement (Howard 2016, pers. comm.).

    Evaluate the feasibility of acquiring conservation easements or fee title purchases on small private land parcels between U.S. Highway 89 and the existing WMA as resources, and willing sellers become available: No easements or property have been acquired, and we do not rely on this conservation action in this final rule to delist the species. However, UDWR has a Statewide initiative to acquire additional lands, so that future acquisition may be possible (Howard 2016, pers. comm.).

    Avoid using herbicides in the species' habitat managed by UDOT: This action is successful and ongoing. The UDOT does not use herbicides in Deseret milkvetch habitat within highway rights-of-way, and has committed to continuing this action as stipulated in the Conservation Agreement (Kisen 2016, pers. comm.).

    Avoid disturbing plants during highway maintenance and construction carried out by UDOT: This action is successful and ongoing. The UDOT has not disturbed the species during highway maintenance and construction, and no highway widening projects are anticipated through at least 2040, which is as far as their planning extends (Kisen 2016, pers. comm.).

    Monitor populations on an annual basis as needed: This action is successful and ongoing. Surveys were conducted in May of 2016, 2017, and 2018 by Utah Natural Heritage Program personnel.

    Continue discussions between the UDWR and Service on the development and review of management plans and habitat restoration that may affect species' habitat on the WMA: This action is successful and ongoing. The Service's Utah Ecological Services Field Office is actively engaged with UDWR in the development and review of actions that may affect the species. The UDWR and Service meet periodically to implement protections identified in the Conservation Agreement.

    In summary, most of the conservation actions described in the Conservation Agreement have been successfully implemented and are part of an ongoing management strategy for conserving Deseret milkvetch. Potential threats from residential development, livestock grazing, and highway maintenance and widening are addressed by conservation actions on the approximately 74 percent of the species' occupied habitat that is owned and managed by either UDWR or UDOT. The Conservation Agreement will continue to be implemented through at least 2036.

    As described above, we have new information on Deseret milkvetch since our listing decision, and the species' status has improved. This improvement is likely due to expanded surveys, as well as the amelioration of threats and an improved understanding of the stressors affecting the species (see Summary of Factors Affecting the Species, below). In addition to the conservation actions identified in the Conservation Agreement, new opportunities for conservation of the species may be implemented in the future. For example, a new power line proposed near the species' habitat will use the same corridor as an existing transmission line (see Factor A discussion, below). However, this future action is not a factor in our delisting determination.

    Survey results from 2017 (the most recent population estimates available) estimated that the total population was 88,427 juvenile and adult plants occurring on approximately 345 ac (140 ha) of habitat, which is a significant increase when compared to estimates of 5,000 to 10,000 plants occurring on approximately 300 ac (122 ha) at the time of listing. The majority of Deseret milkvetch occupied habitat (74 percent) is managed by UDWR and UDOT, and we have no information that indicates the species faces significant threats on private lands. All of the conservation actions for UDWR- and UDOT-managed habitat have been successfully implemented, with the exception of acquiring conservation easements. These measures have been effective in preventing impacts to the species and its habitat on State-managed lands. Additionally, as described below, threats identified at the time of listing in 1999 are not as significant as originally anticipated (U.S. Fish and Wildlife Service 2011, p. 21).

    Summary of Changes From the Proposed Rule

    We have made updates to our discussions of the species' population status (including 2017 information) and factors affecting the species, based on comments submitted by the public and information provided by peer reviewers. In addition, we now refer to the species primarily by its common name, rather than its scientific name, throughout this rule.

    Summary of Factors Affecting the Species

    Section 4 of the Act (16 U.S.C. 1531 et seq.) and its implementing regulations (50 CFR part 424) set forth the procedures for listing species, reclassifying species, or removing species from listed status. “Species” is defined by the Act as including any species or subspecies of fish or wildlife or plants, and any distinct vertebrate population segment of fish or wildlife that interbreeds when mature (16 U.S.C. 1532(16)). A species is an “endangered species” for purposes of the Act if it is in danger of extinction throughout all or a significant portion of its range and is a “threatened species” if it is likely to become endangered within the foreseeable future throughout all or a significant portion of its range. We consider “foreseeable future” as that period of time within which a reliable prediction can be reasonably relied upon in making a determination about the future conservation status of a species, as described in the Solicitor's opinion dated January 16, 2009 (M-37021).

    A species may be determined to be an endangered or threatened species because of one or more of the five factors described in section 4(a)(1) of the Act: (A) The present or threatened destruction, modification, or curtailment of its habitat or range; (B) overutilization for commercial, recreational, scientific, or educational purposes; (C) disease or predation; (D) the inadequacy of existing regulatory mechanisms; or (E) other natural or manmade factors affecting its continued existence. We must consider these same five factors in delisting a species.

    For species that are already listed as endangered or threatened and being considered for delisting, the five-factor analysis is an evaluation of the threats currently facing the species and the threats that are reasonably likely to affect the species in the foreseeable future following the removal of the Act's protections. We may delist a species according to 50 CFR 424.11(d) if the best available scientific and commercial data indicate that the species is neither endangered nor threatened for the following reasons: (1) The species is extinct; (2) the species has recovered and is no longer endangered or threatened; and/or (3) the original scientific data used at the time the species was classified were in error. A recovered species has had threats removed or reduced to the point that it no longer meets the Act's definitions of endangered or threatened.

    Deseret milkvetch is listed as a threatened species. For the purposes of this analysis, we will evaluate whether or not the currently listed species, Deseret milkvetch, should continue to be listed as a threatened species, based on the best scientific and commercial information available.

    We consider 20 years to be a reasonably foreseeable future within which reliable predictions can be made for Deseret milkvetch. This time period includes multiple generations of the species, coincides with the duration of the Conservation Agreement, and falls within the planning period used by UDOT. We consider 20 years a conservative timeframe in view of the much longer-term protections in place for 67 percent of the species' occupied habitat that occurs within the UDWR WMA.

    In considering what factors might constitute threats, we must look beyond the exposure of the species to a particular factor to evaluate whether the species may respond to the factor in a way that causes actual impacts to the species. If there is exposure to a factor and the species responds negatively, the factor may be a threat, and during the five-factor threats analysis, we will attempt to determine the significance of the threat. The threat is significant if it drives or contributes to the risk of extinction of the species such that the species warrants listing as endangered or threatened as those terms are defined by the Act. However, the identification of factors that could affect a species negatively may not be sufficient to justify a finding that the species warrants listing or should remain listed. The information must include evidence sufficient to suggest that the potential threat is likely to materialize and that it has the capacity (sufficient magnitude and extent) to affect the species' status such that it meets the definition of endangered or threatened under the Act. This determination does not necessarily require empirical proof of a threat. The combination of exposure and some corroborating evidence of how the species is likely impacted could suffice. The following analysis examines the factors currently affecting Deseret milkvetch, or that are likely to affect it within the foreseeable future.

    A. The Present or Threatened Destruction, Modification, or Curtailment of Its Habitat or Range

    Deseret milkvetch is found in three different land use zones, as categorized by Utah County Land Use Ordinance (Jorgensen 2016b, pers. comm.; Utah County 2016, chapter 5). Approximately 74.6 percent of the species' habitat occurs in Critical Environment Zone 1, which has the primary purpose of supporting water resources for culinary use, irrigation, recreation, natural vegetation, and wildlife. Approximately 16.7 percent occurs in Residential Agricultural Zone 5, which has the primary purpose of preserving agricultural lands. The remaining 8.6 percent occurs in Critical Environment Zone 2, which has the primary purpose of preserving fragile environmental uses (Jorgensen 2016b, pers. comm.). These zones do not strictly regulate management or land use and, therefore, are not discussed under Factor D, below; however, the Utah County Land Use Ordinance prioritizes uses and provides management guidance for all lands in Utah County, unless specifically exempted (Utah County 2016, chapter 5). All of the conservation actions in place for the species meet the guidelines under their respective land use zone, and we are not aware of any occupied habitat specifically exempted from the guidance described for the aforementioned land use zones.

    The following potential stressors were identified for this species at the time of listing: (1) Residential development, (2) highway maintenance and widening, and (3) livestock grazing and trampling. For this final rule, we also considered: (4) Mineral development, (5) transmission lines, and (6) climate change. Each of these stressors is assessed below.

    Residential Development

    In our October 20, 1999, final listing rule (64 FR 56590), substantial human population growth and urban expansion were predicted in the Provo, Spanish Fork, and Weber River drainages east of the Wasatch Mountains. In that rule, increased residential development was considered a threat to the species due to the potential for loss of plants and habitat that results from the construction of roads, buildings, and associated infrastructure (e.g., utilities). However, counter to the predictions of the Quality Growth Efficiency Tools Technical Committee cited in that final listing rule, residential development in these areas has been very limited. The nearest community, Birdseye, is unincorporated and has not been included in recent U.S. Census Bureau surveys; therefore, no recent population estimates are available. We are aware of only one house, and a barn that was recently built adjacent to Deseret milkvetch occupied habitat (Fitts 2016, pers. comm.). We are aware of only three proposed development properties in this area. One property has the potential for 95 lots and is 2.8 mi (4.5 km) from the known occupied habitat of Deseret milkvetch. The other two developments would be single dwelling properties approximately four mi (6 km) and five mi (8 km) from known occupied habitat (Larsen 2016, pers. comm.; Jorgensen 2016a, pers. comm.). These three proposed developments are located near Thistle Creek, upstream from Deseret milkvetch habitat (Jorgensen 2016a, pers. comm.). However, the species' habitat occurs on steep upland slopes that are not vulnerable to potential habitat impacts from upstream areas. Residential development at this scale and distance from Deseret milkvetch population is not likely to impact the species or its habitat now or within the foreseeable future.

    The majority of Deseret milkvetch habitat occurs on steep, rocky, erosive slopes that are not favorable for development; consequently, we do not anticipate any future residential development in the species' occupied habitat (Fitts 2016, pers. comm.). Additionally, as previously described, approximately 230 ac (93 ha)—67 percent of total habitat for the species—are in a WMA owned by the UDWR that is protected from residential development, as discussed under Factor D, below.

    We conclude, based on the available information, that residential development is not a threat to Deseret milkvetch due to: (1) The minimal disturbance from residential development that has occurred on the species' habitat to date and the minimal amount of disturbance anticipated in the future; (2) the steep, rocky, erosive nature of the species' habitat, which precludes most development; and (3) the amount of habitat (67 percent) that is protected from residential development.

    Highway Widening and Maintenance

    In our October 20, 1999, final listing rule (64 FR 56590), potential widening of Highway 89 was considered a threat to plants growing in the highway right-of-way. Highway 89 widening would likely result in the loss of Deseret milkvetch plants and habitat that are directly adjacent to Highway 89. Regular highway maintenance activities include herbicide use to control weeds and could also result in the loss of plants and habitat within the right-of-way. The species appears to tolerate some levels of disturbance related to road maintenance because it recolonizes areas that have been disturbed by tracked vehicles, road grading equipment, and road cuts (Franklin 1990, p. 2; Fitts and Fitts 2009, p. 5; SWCA 2015, p. 7).

    Widening of Highway 89 has not occurred and is not anticipated by UDOT through at least 2040, which is as far as planning extends (Kisen 2016, pers. comm.). The nearest highway development project is a modification of the intersection of Highway 89 and Highway 6 (Kisen 2016, pers. comm.). This project is approximately seven mi (11 km) north of Birdseye and four mi (6 km) north of the nearest occurrence of the species. Therefore, we do not anticipate any direct or indirect impacts to the species. No other highway projects are currently planned within 20 mi (32 km) of Birdseye (Kisen 2016, pers. comm.).

    Road maintenance on Highway 89 is ongoing. However, as committed to in the Conservation Agreement, UDOT avoids herbicide use and other disturbance in the species' habitat (Lewinsohn 2016, pers. comm.; UDWR et al. 2006, p. 9). In instances where herbicides must be used, UDOT will not apply it by an aerial application within 500 ft (152.5 m) of occupied habitat and will maintain a 100-ft (30-m) buffer for hand application around individual plants (UDWR et al. 2006, p. 9).

    In summary, highway widening is not anticipated within the vicinity of occupied Deseret milkvetch habitat. We are not aware of planned road-widening construction projects in or near the species' habitat, and UDOT has committed to avoiding herbicide use and other disturbance in occupied Deseret milkvetch habitat during maintenance activities (Lewinsohn 2016, pers. comm.; UDWR et al. 2006, p. 9). Therefore, based on the available information, we conclude that highway widening and maintenance are not a threat to Deseret milkvetch.

    Livestock Grazing and Trampling

    In our October 20, 1999, final listing rule (64 FR 56590), livestock grazing and trampling were considered threats to the species because of direct consumption of plants, trampling of plants and the burrows of ground-dwelling pollinators, and increased soil erosion. In contrast to many species of Astragalus, this species apparently is not toxic to livestock, and is palatable and may be consumed (Stone 1992, p. 6; Tilley et al. 2010, p. 1).

    Prior to UDWR acquiring the Northwest Manti WMA in 1967, livestock grazing occurred for more than 50 years on habitat occupied by Deseret milkvetch and may help to explain why attempts to locate the species were unsuccessful for decades (UDWR et al. 2006, p. 6). Once UDWR acquired the land, they chained (removed scrub growth) and seeded level land upslope of the species' habitat to improve grazing for wild ungulates and livestock. The last cattle grazing on the Wildlife Management Unit occurred in 2002 (U.S. Fish and Wildlife 2011, p. 17).

    The UDWR does not currently allow livestock grazing on the Birdseye Unit of the WMA and does not plan for any future grazing within the portion of the WMA that contains Deseret milkvetch habitat (Howard 2018, pers. comm.). Avoidance of livestock grazing in the species' habitat that is managed by UDWR is stipulated in the Conservation Agreement (UDWR et al. 2006, p. 8). Additionally, the species' habitat is not well-suited to grazing due to sparse forage and steep slopes. Some private lands where the species occurs allow livestock grazing; however, when last visited, there was no evidence of impacts to the species (U.S. Fish and Wildlife 2011, p. 17).

    In summary, livestock grazing and trampling were considered a threat to Deseret milkvetch in our October 20, 1999, final listing rule (64 FR 56590) because grazing occurred historically over much of the species' habitat and we were concerned about trampling and erosion impacts. However, livestock grazing no longer occurs on the UDWR WMA, representing 67 percent of the species' habitat. Additionally, occupied Deseret milkvetch habitat on both private and protected lands is steep and rocky, with sparse forage for cattle. Consequently, minimal grazing impacts have been documented. We conclude, based on the available information, that livestock grazing and trampling are not a threat to Deseret milkvetch.

    Mineral Development

    Impacts from mineral development were not considered in our October 20, 1999, final listing rule (64 FR 56590). At the time the Conservation Agreement was signed, there was no information indicating that mineral development was going to occur in or near occupied Deseret milkvetch habitat (UDWR et al. 2006, p. 7). SITLA owns the mineral rights on most of the land occupied by the species, and the agency has not had any inquiries regarding mineral development in the species' habitat since the Conservation Agreement was signed (UDWR et al. 2006, p. 7; Wallace 2017, pers. comm.). In the Conservation Agreement, which will remain in effect through 2036, SITLA agreed to alert any energy and mineral developers to the presence of occupied habitat and recommend surface use stipulations that avoid disturbance and provide mitigation for unavoidable effects to plants or their habitat (UDWR et al. 2006, p. 8).

    In summary, mineral development was not considered a threat when Deseret milkvetch was listed under the Act. According to the compliance office of SITLA, there have been no inquiries regarding mineral development in this area. It is a severed estate, therefore, SITLA does not own the mineral rights, but would manage surface disturbance associated with mineral development and the area is flagged in their business system as being under a conservation agreement (Wallace 2017, pers. comm.). Therefore, based on the available information, we conclude that mineral development is not a threat to Deseret milkvetch.

    Transmission Lines

    Impacts from transmission lines were not considered in our October 20, 1999, final listing rule (64 FR 56590). The Mona to Bonanza high-voltage transmission line is an existing power line near Deseret milkvetch habitat located at the easternmost extent of the known range of the species (Miller 2016, pers. comm.). The TransWest Express transmission line is a planned power line that would use the same corridor as the existing Mona to Bonanza transmission line (SWCA Environmental Consultants 2015, p. 1). TransWest Express developers estimated that approximately 10.9 ac (4.4 ha) of potential or occupied habitat for the species occurs within 300 ft (91 m) of proposed transmission structures, and approximately 0.25 ac (0.10 ha) would be directly disturbed (SWCA Environmental Consultants 2015, p. 17). However, minimal impacts are expected to result from the transmission line installation because dust abatement measures would be implemented, the proposed route is located farther away from Deseret milkvetch populations than the existing Mona to Bonanza transmission line, and existing access roads would be used within the species' habitat (U.S. Fish and Wildlife Service 2016, pp. 25-31). Consequently, impacts from the proposed TransWest Express transmission line are not anticipated to result in a population-level effect to the species based upon the localized extent of impacts and the currently robust status of the species (see Species Abundance, Distribution, and Trends, above). In addition, because the species can tolerate some levels of disturbance and plants have recolonized disturbed areas, any remaining development-related impacts should be minimal (Fitts and Fitts 2009, p. 5; Franklin 1990, p. 2).

    In summary, Deseret milkvetch maintains a large, robust population next to the existing Mona to Bonanza transmission line, and only a very minimal amount of habitat (less than 0.25 ac (0.10 ha)) would be disturbed by the proposed future construction of the TransWest transmission line. We conclude, based on the available information, that transmission lines are not a threat to Deseret milkvetch.

    Effects of Climate Change

    Impacts from climate change were not considered in our October 20, 1999, final listing rule (64 FR 56590). Our current analyses for species classification under the Act include consideration of ongoing and projected changes in climate. The terms “climate” and “climate change” are defined by the Intergovernmental Panel on Climate Change (IPCC). “Climate” refers to the mean and variability of different types of weather conditions over time, with 30 years being a typical period for such measurements, although shorter or longer periods also may be used (IPCC 2007, p. 78). The term “climate change” thus refers to a change in the mean or variability of one or more measures of climate (e.g., temperature or precipitation) that persists for an extended period, typically decades or longer, whether the change is due to natural variability, human activity, or both (IPCC 2007, p. 78). Various types of changes in climate can have direct or indirect effects on species. These effects may be positive, neutral, or negative, and they may change over time, depending on the species and other relevant considerations, such as the effects of interactions of climate with other variables (e.g., habitat fragmentation) (IPCC 2007, pp. 8-14, 18-19). In our analyses, we use our expert judgment to weigh relevant information, including uncertainty, in our consideration of various aspects of climate change.

    Estimates regarding the risk of future persistent droughts in the southwestern United States range from 50 to 90 percent (Ault et al. 2013, p. 7545). Climate models that predict future temperatures over three different time periods in the 21st century for the southwestern United States show the greatest warming in summer months (3.5 to 6.5 degrees Fahrenheit (°F)) (1.9 to 3.6 degrees Celsius (°C)), with a localized maximum increase in temperatures in central Utah (Kunkel et al. 2013, p. 72). Nationwide, Utah ranks eighth in rate of warming since 1912, with a 0.233 °F (0.129 °C) increase per decade; and seventh in rate of warming since 1970, with a 0.588 °F (0.327 °C) increase per decade (Tebaldi et al. 2012, pp. 3, 5).

    The Astragalus genus has the ability to colonize disturbed or unstable habitats in progressively dry climates and thus appears to be adapted to drought (Stone 1992, p. 6). We do not have a clear understanding of how Deseret milkvetch responds to precipitation changes, although the species has persisted in spite of recent dry conditions. Generally, plant numbers decrease during drought years and recover in subsequent seasons that are less dry. For example, many plants of Deseret milkvetch appeared to die-off in response to the 2012 drought, but have since repopulated the area from the seed bank (Fitts 2016, pers. comm.). Deseret milkvetch and other species in the bean family typically have persistent seed banks with at least some proportion of the seed bank being long-lived because the seeds are physically dormant for long periods of time (Dodge 2009, p. 3; Orscheg and Enright 2011, p. 186; Segura et al. 2014, p. 75). Dormant seeds have a seed coat that imposes a physical barrier between water and the embryo, and this type of dormancy provides an ecological advantage by staggering germination over a long period of time, protecting the embryo from microbial attack, and increasing the longevity of seeds within the soil (Fulbright 1987, p. 40). Species with physically dormant seeds typically have seeds germinating over many years, which increases the probability of the species' persistence in an unpredictable environment and has been termed a “bet-hedging strategy” (Simons 2009, pp. 1990-1991; Williams and Elliott 1960, pp. 740-742). This strategy buffers a population against catastrophic losses and negative effects from environmental variation (Tielbörger et al. 2014, p. 4). Deseret milkvetch can be dormant and not detectable for some years, but later detected in the same area given favorable precipitation conditions (Fitts 2016, pers. comm.). This pattern provides some evidence the species has a persistent seed bank and possibly other life stages that remain dormant during drought conditions.

    Deseret milkvetch appears well-adapted to a dry climate and can quickly colonize after disturbance. Plants growing in high-stress landscapes (e.g., poor soils and variable moisture) are generally adapted to stress and thus may experience lower mortality during severe droughts (Gitlin et al. 2006, pp. 1477, 1484). Furthermore, plants and plant communities of arid and semi-arid systems may be less vulnerable to the effects of climate change if future climate conditions are within the historic natural climatic variation experienced by Deseret milkvetch (Tielbörger et al. 2014, p. 7). The species likely has experienced multiple periods of prolonged drought conditions in the past as documented from reconstructed pollen records in sagebrush steppe lands (Mensing et al. 2007, pp. 8-10). Natural climatic variation in the Southwest for the last 500 years included periodic major droughts (Kunkle et al. 2013, p. 14). Therefore, it is likely that Deseret milkvetch will be able to withstand future periods of prolonged drought.

    In summary, climate change is affecting and will continue to affect temperature and precipitation events. We expect that Deseret milkvetch, like other narrow endemics, could experience future climate change-related drought. However, the scope of any effects is mostly speculative at this time because current data are not reliable at the local level. The information we do have indicates the species and the genus are adapted to drought and are able to recolonize disturbed areas. Therefore, based upon available information, we conclude that climate change is not a threat to Deseret milkvetch currently or within the foreseeable future.

    Summary of Factor A

    The following stressors warranted consideration as possible current or future threats to Deseret milkvetch under Factor A: (1) Residential development, (2) highway maintenance and widening, (3) livestock grazing and trampling, (4) mineral development, (5) transmission lines, and (6) climate change. However, these stressors either have not occurred to the extent anticipated at the time of listing or are being adequately managed, or the species is tolerant of the stressor as described below.

    • Minimal disturbance from residential development has occurred on Deseret milkvetch habitat to date or is anticipated in the future because of the steep, rocky, erosive nature of the species' habitat. In addition, 67 percent of the species' habitat is protected from residential development due to its inclusion in a State WMA.

    • UDOT anticipates no highway widening in habitat occupied by Deseret milkvetch, and herbicide use and other disturbances are avoided in habitat for the species.

    • The steep, rocky nature of Deseret milkvetch habitat and sparse forage availability minimize livestock grazing, and 67 percent of all of the species' known habitat is carefully managed by UDWR to restrict it from grazing.

    • The lack of inquiries and severed estate status of the habitat occupied by Deseret milkvetch indicate that mineral development is not a threat.

    • The existing transmission line is not a threat to Deseret milkvetch, and activity associated with the proposed transmission line occurring within the species' occupied habitat will be confined to existing access roads.

    • Deseret milkvetch and its genus are likely adapted to drought related to climate change.

    • Deseret milkvetch appears able to recolonize disturbed areas readily.

    Therefore, based on the available information, we do not consider there to be any threats related to the present or threatened destruction, modification, or curtailment of habitat or range of Deseret milkvetch.

    B. Overutilization for Commercial, Recreational, Scientific, or Educational Purposes

    Overutilization for any purpose was not considered a threat in the final rule to list the species (64 FR 56590; October 20, 1999). The only collections of the species that we are aware of were for scientific purposes. An unknown number of seeds were collected in 2007, and approximately 850 seeds were collected from 45 plants in 2008. In addition, 1,016 seeds were collected from 55 plants in 2009, for germination trials and long-term seed storage at Red Butte Gardens and Arboretum in Salt Lake City, Utah, and the National Center for Genetic Resources Preservation in Fort Collins, Colorado (Dodge 2009, p. 4). This amount of collection is insignificant given the current population estimates for the species, and overall it is beneficial because it will improve our understanding of species propagation and ensure genetic preservation. We are not aware of any other utilization of the species. Therefore, based on the available information, we do not consider there to be any threats related to overutilization for commercial, recreational, scientific, or educational purposes of Deseret milkvetch.

    C. Disease or Predation

    Disease and predation were not considered threats in the final rule to list the species (64 FR 56590; October 20, 1999). We are not aware of any issues or potential stressors regarding disease or insect predation. As described in more detail above under Factor A, grazing—which could be considered a form of predation—is limited in the species' habitat and does not affect the species throughout its range or at a population level. Therefore, based on the available information, we do not consider there to be any threats related to disease or predation of Deseret milkvetch.

    D. The Inadequacy of Existing Regulatory Mechanisms

    Section 4(b)(1)(A) of the Act requires the Service to take into account “those efforts, if any, being made by any State or foreign nation, or any political subdivision of a State or foreign nation, to protect such species.” In relation to Factor D under the Act, we interpret this language to require us to consider relevant Federal, State, and Tribal laws, regulations, and other such mechanisms that may minimize any of the threats we describe in the threats analyses under the other four factors or otherwise enhance conservation of the species. We give the strongest weight to statutes and their implementing regulations and to management direction that stems from those laws and regulations; an example would be State governmental actions enforced under a State statute, constitution, or regulation or Federal action under statute or regulation.

    For currently listed species that are being considered for delisting, we consider the adequacy of existing regulatory mechanisms to address threats to the species absent the protections of the Act. We examine whether other regulatory mechanisms would remain in place if the species were delisted, and the extent to which those mechanisms would continue to help ensure that future threats will be reduced or minimized.

    In our discussion under Factors A, B, C, and E, we evaluate the significance of threats as mitigated by any conservation efforts and existing regulatory mechanisms. Where threats exist, we analyze the extent to which conservation measures and existing regulatory mechanisms address the specific threats to the species. Regulatory mechanisms, if they exist, may reduce or eliminate the impacts from one or more identified threats. As previously discussed, conservation measures initiated by UDWR, SITLA, and UDOT under the Conservation Agreement manage potential threats caused by residential development, highway maintenance and widening, and livestock grazing and trampling, as well as the more recently identified proposed transmission line. In addition to these conservation measures, relevant Utah State statutes and UDWR administrative rules that will remain in effect regardless of Deseret milkvetch's status under the Act include:

    1. Title 23—Wildlife Resources Code of Utah, Chapter 21—Lands and Waters for Wildlife Purposes, Section 5—State-owned lands authorized for use as wildlife management areas, fishing waters and other recreational activities. This statute authorizes the creation, operation, maintenance, and management of wildlife management areas including the Birdseye Unit of the Northwest Manti WMA. The Birdseye Unit contains 67 percent of all known habitat occupied by Deseret milkvetch. Consequently, two-thirds of all known habitat is currently managed and will continue to be managed as wildlife habitat regardless of the species' status under the Act.

    2. Utah Administrative Code, Rule R657-28—Use of Division Lands. This administrative rule describes the lawful uses and activities on UDWR lands including Birdseye Unit of the Northwest Manti WMA. These uses cannot conflict with the intended land use or be detrimental to wildlife or wildlife habitat. This administrative rule provides further support to beneficial management on the 67 percent of occupied habitat managed by UDWR, regardless of the species' status under the Act.

    We are not aware of any habitat occupied by Deseret milkvetch on Federal lands. We anticipate that the conservation measures initiated by UDWR, SITLA, and UDOT under the Conservation Agreement will continue through at least 2036. Consequently, we find that conservation measures along with existing State regulatory mechanisms are adequate to address specific stressors absent protections under the Act.

    E. Other Natural or Manmade Factors Affecting Its Continued Existence Rarity

    In our October 20, 1999, final listing rule (64 FR 56590), small population size was considered a concern for the species because of the potential for low levels of genetic diversity as compared to other more widespread, related species. A species may be considered rare due to: (1) Limited geographic range, (2) occupation of specialized habitats, or (3) small population numbers (Primack 1998, p. 176). This species meets each of these qualifications.

    Deseret milkvetch is likely a localized neoendemic, that is, it is a relatively new species on the scale of geologic time and likely has always been geographically restricted (rare) (Stone 1992, p. 6). A species that has always been rare, yet continues to survive, could be well-equipped to continue to exist in the future. Many naturally rare species exhibit traits that allow them to persist for long periods within small geographic areas, despite their small population size. Consequently, the fact that a species is rare does not necessarily indicate that it may be endangered or threatened. Rarity alone, in the absence of other stressors, is not a threat. Despite the species' unique habitat characteristics and limited range, its current population numbers and preliminary demographic analyses show that its known population (via information at monitored sites) is much larger than in 1990, when the first surveys were conducted, and will likely be sustained due to the species' resiliency and the absence of significant stressors. Additionally, as noted under Factor B, above, seeds have been collected for long-term seed storage at Red Butte Gardens and Arboretum in Salt Lake City, Utah, and the National Center for Genetic Resources Preservation in Fort Collins, Colorado (Dodge 2009, p. 4). This collection provides added security for the species.

    Stochastic Events

    In our October 20, 1999, final listing rule (64 FR 56590), stochastic events—particularly fire, drought, and disease—were considered a threat because of the species' small population size and highly restricted range. Because rare species may be vulnerable to single event occurrences, it is important to have information on how likely it is such an event may occur and how it may affect the species. Demographic stochasticity—random events in survival and reproductive success—and genetic stochasticity—from inbreeding and changes in gene frequency—are not significant threats based on limited abundance trends and the known population size of Deseret milkvetch (Stone 1992, pp. 8-10).

    Environmental stochasticity—such as fire, drought, and disease—may also be a threat to the species (Stone 1992, p. 10). However, we have concluded that fire is unlikely in the open, a sparsely wooded habitat that the species favors (72 FR 3379, January 25, 2007; U.S. Fish and Wildlife 2011, p. 21). As explained above under “Climate Change” in the Factor A discussion, the species appears to be drought tolerant, showing an ability to rebound the following drought and recolonize disturbed areas in progressively dry climates. Lastly, as noted above in the Factor C discussion, there is no evidence of disease or insect pests affecting Deseret milkvetch. Since listing in 1999, survey data have shown that the species' known range is somewhat larger and its population numbers are much higher than previously thought, thus indicating tolerance to stochastic events. These increases are likely due to a combination of expanded surveys and increases in population.

    Summary of Factor E

    Given the lack of threats within the Deseret milkvetch population and the robust population size, we conclude that rarity and stochastic events are not threats to the species.

    Cumulative Effects

    Many of the stressors discussed in this analysis could work in concert with each other and result in a cumulative adverse effect to Deseret milkvetch, i.e., one stressor may make the species more vulnerable to other threats. For example, stressors discussed under Factor A that individually do not rise to the level of a threat could together result in habitat loss. Similarly, small population size in combination with stressors discussed under Factor A (residential development, highway maintenance and widening, livestock grazing and trampling, mineral development, transmission lines, and climate change) could present a potential concern.

    However, most of the potential stressors we identified either have not occurred to the extent originally anticipated at the time of listing in 1999 or are adequately managed as described in this final rule. Furthermore, those stressors that are evident, such as drought and rarity, appear well-tolerated by the species. In addition, we do not anticipate stressors to increase on UDWR lands that afford protections to the species on 67 percent of occupied habitat for the reasons discussed earlier in this rule. Furthermore, the increases documented in the abundance and distribution of the species since it was listed in 1999 do not support a conclusion that cumulative activities threaten the species.

    Summary of Comments and Recommendations

    In the proposed rule published in the Federal Register on October 2, 2017 (82 FR 45779), we requested that all interested parties submit written comments on the proposal by December 1, 2017. We also contacted appropriate Federal and State agencies, scientific experts and organizations, and other interested parties and invited them to comment on the proposal. We did not receive any requests for a public hearing. All substantive information provided during the comment period has either been incorporated directly into this final determination or is addressed below.

    Peer Reviewer Comments

    In accordance with our peer review policy published on July 1, 1994 (59 FR 34270) and updated guidance issued on August 22, 2016 (USFWS 2016, entire), we solicited expert opinion from three knowledgeable individuals with scientific expertise that included familiarity with Deseret milkvetch, its habitat, its biological needs and potential threats, or principles of conservation biology. We received responses from all of the peer reviewers.

    We reviewed all comments we received from the peer reviewers for substantive issues and new information regarding the proposed delisting of Deseret milkvetch. The peer reviewers provided additional information, clarifications, and suggestions to improve the final rule. We included their information in this final rule. Two peer reviewers were supportive of the delisting action. The third provided only minor technical comments and editorial suggestions on the rule and did not express an opinion regarding the action.

    Public Comments

    We received 15 letters from the public (as well as one from a peer reviewer) that provided comments on the proposed rule. Of these, six commenters stated their support for the delisting of Deseret milkvetch, and six commenters believed that it does not warrant delisting. We also received three comments that were not directly related to the proposed action in any way and are not addressed below.

    Relevant public comments are addressed in the following summary, and new information was incorporated into the final rule as appropriate.

    (1) Comment: We received four public comments that the species should not be delisted based primarily on its limited range and single population.

    Our Response: Rarity or range restriction alone is not a basis for determining that a species meets the definition of “endangered species” or “threatened species.” Our analysis of the best commercial and scientific information available indicates that the population of Deseret milkvetch is secure. We also determined that despite the limited range of this species, stressors either have not occurred to the extent anticipated at the time of listing in 1999 or are being adequately managed, or the species is tolerant of the stressor.

    (2) Comment: We received one comment that our proposed delisting was premature because survey data results from 2016 were not available at the time of publication of the proposed rule (October 2, 2017). This commenter suggested that we should not base our decision on information that was being excluded from public access.

    Our Response: The proposed delisting was based on the best commercial and scientific information available at the time. We did not have access to 2016 survey data at the time and did not base our decision on it or withhold this information from the public. Partial surveys were conducted in 2016, and full surveys were conducted in 2017. This rule has been updated with relevant information from both years. Survey results are not yet available for 2018.

    (3) Comment: We received two public comments suggesting that additional surveys should be conducted before the species is delisted, to provide more information on population status and also how stressors are impacting the population.

    Our Response: This final rule includes survey information from 2017, which supports our conclusion that the species has maintained occupancy and a robust population. Additionally, the post-delisting monitoring (PDM) plan provides for a minimum of 5 years of annual monitoring after this rule takes effect. The PDM plan also includes criteria to determine whether population trends allow for completion of monitoring, or if additional monitoring or a status review is needed. We believe this will provide adequate confirmation of population stability in the absence of the Act's protections.

    (4) Comment: We received four public comments supporting the delisting of Deseret milkvetch on the basis that its listing has impeded human use on the land it occupies, specifically in regards to grazing and off-road vehicle use. These comments suggested the species should be delisted so that grazing and off-road vehicle use could increase within the habitat.

    Our Response: We may only base our determination of the status of a species on the best available commercial or scientific information. We may not consider the impact to land management or the demand for other uses within the species' habitat when determining whether a species is endangered or threatened, except insofar as to whether such uses represent stressors that may threaten the species. Additionally, a conservation agreement for this species remains in effect, and we do not anticipate existing regulations regarding motorized vehicle use or grazing in the habitat to change as a result of this delisting. If the human use of the habitat for recreation, grazing, or other purposes increase significantly in the future, a reassessment of this species' status may be initiated.

    (5) Comment: We received a comment stating that the lack of a recovery plan for the species, combined with the voluntary nature of the existing Conservation Agreement and the fact that only 18 years remain in the current agreement, means that adequate protections are not provided to the species in the absence of the protections of the Act.

    Our Response: Recovery plans provide roadmaps to species recovery, but are not required in order to achieve recovery of a species or to evaluate it for delisting. Recovery plans are also nonbinding documents that rely on voluntary participation from landowners, land managers, and other recovery partners. Additionally, we have no information to suggest that UDWR, SITLA, and UDOT will not continue to act in good faith according to the Conservation Agreement as it exists. A listing decision must consider actions taken by States to provide for the conservation of a species. Lack of continued implementation of the Conservation Agreement or large changes in management practices in the species' habitat by the State of Utah may result in reevaluation of the status of Deseret milkvetch.

    (6) Comment: We received one public comment stating that the projected development rates in Utah County are likely to negatively impact Deseret milkvetch habitat to the degree that would constitute a species-level threat; thus, delisting the species at this time is not appropriate.

    Our Response: We agree that residential development in Utah County is increasing and that the patterns of such development are not entirely predictable. However, we have no information to suggest that development within Deseret milkvetch occupied habitat on private lands is imminent. Furthermore, development is prohibited within the Birdseye Wildlife Management Unit, which represents the majority of the known population. For additional detail, see our threats analysis under A. The Present or Threatened Destruction, Modification, or Curtailment of Its Habitat or Range.

    (7) Comment: We received a public comment stating that we should not delist Deseret milkvetch due to our lack of information regarding the species, particularly in the areas of population biology, population viability, genetics, phenology, and response to stressors.

    Our Response: We utilized the best scientific and commercial information available for this species in our determination. We conclude that enough information is available for Deseret milkvetch and its stressors to adequately evaluate its status. Should additional research or post-delisting monitoring in the future provide information that indicates our evaluation is in error or, the species' status has declined since delisting, we would reevaluate the status of the species based on this information.

    Determination of Species Status

    Section 4 of the Act (16 U.S.C. 1533), and its implementing regulations at 50 CFR part 424, set forth the procedures for determining whether a species meets the definition of “endangered species” or “threatened species.” The Act defines an endangered species as any species that is “in danger of extinction throughout all or a significant portion of its range” and a threatened species as any species “that is likely to become an endangered species within the foreseeable future throughout all or a significant portion of its range.” The Act requires that we determine whether a species meets the definition of “endangered species” or “threatened species” because of any of the following factors:

    (A) The present or threatened destruction, modification, or curtailment of its habitat or range;

    (B) Overutilization for commercial, recreational, scientific, or educational purposes;

    (C) Disease or predation;

    (D) The inadequacy of existing regulatory mechanisms; or

    (E) Other natural or manmade factors affecting its continued existence.

    The same factors apply whether we are analyzing the species' status throughout all of its range or a significant portion of its range.

    Determination of Status Throughout All of Deseret Milkvetch's Range

    We conducted a review of the status of Deseret milkvetch and assessed the five factors to evaluate whether Deseret milkvetch is in danger of extinction, or likely to become so in the foreseeable future, throughout all of its range. We also consulted with species experts and land management staff with UDWR and UDOT who are actively managing for the conservation of the species. We carefully assessed the best scientific and commercial information available regarding the past, present, and future threats to the species. We considered all of the stressors identified at the time of listing (1999) as well as newly identified potential stressors such as mineral development, transmission lines, and climate change. As previously described, the stressors considered in our five-factor analysis fall into one or more of the following categories:

    • Stressors including residential development, highway widening, and livestock grazing and trampling have not occurred to the extent anticipated at the time of listing, and existing information indicates that the extent of the impact will not change in the future.

    • Stressors including highway maintenance, livestock grazing, transmission lines, and mineral development are adequately managed through the Conservation Agreement.

    • The species is tolerant of stressors including climate change, rarity, stochastic events, and cumulative effects, and existing information indicates that this tolerance will not change in the future.

    These conclusions are supported by the available information regarding species abundance, distribution, and trends, and are in agreement with information presented in our advance notice of proposed rulemaking (72 FR 3379; January 25, 2007), in our 5-year review (U.S. Fish and Wildlife Service 2011), and in our proposed delisting rule (82 FR 45779; October 2, 2017). Thus, after assessing the best available information, we conclude that Deseret milkvetch is not in danger of extinction throughout all of its range, nor is it likely to become so in the foreseeable future.

    Because we determined that Deseret milkvetch is not in danger of extinction or likely to become so in the foreseeable future throughout all of its range, we will consider whether the Deseret milkvetch is in danger of extinction or likely to become so in the foreseeable future within any significant portions of its range.

    Determination of Status Throughout a Significant Portion of Deseret Milkvetch's Range

    Under the Act and our implementing regulations, a species may warrant listing if it is in danger of extinction or likely to become so in the foreseeable future throughout all or a significant portion of its range. The Act defines “endangered species” as any species which is “in danger of extinction throughout all or a significant portion of its range,” and “threatened species” as any species which is “likely to become an endangered species within the foreseeable future throughout all or a significant portion of its range.” The term “species” includes “any subspecies of fish or wildlife or plants, and any distinct population segment [DPS] of any species of vertebrate fish or wildlife which interbreeds when mature.” We published a final policy interpreting the phrase “significant portion of its range” (SPR) (79 FR 37578; July 1, 2014). The final policy states that: (1) If a species is found to be an in danger of extinction or likely to become so in the foreseeable future throughout a significant portion of its range, the entire species is listed as an endangered species or a threatened species, respectively, and the Act's protections apply to all individuals of the species wherever found; (2) a portion of the range of a species is “significant” if the species is not currently in danger of extinction or likely to become so in the foreseeable future throughout all of its range, but the portion's contribution to the viability of the species is so important that, without the members in that portion, the species would be in danger of extinction, or likely to become so in the foreseeable future, throughout all of its range; (3) the range of a species is considered to be the general geographical area within which that species can be found at the time the Service or the National Marine Fisheries Service makes any particular status determination; and (4) if a vertebrate species is in danger of extinction or likely to become so in the foreseeable future throughout an SPR, and the population in that significant portion is a valid DPS, we will list the DPS rather than the entire taxonomic species or subspecies.

    The SPR policy is applied to all status determinations, including analyses for the purposes of making the listing, delisting, and reclassification determinations. However, we acknowledge the recent adverse ruling by the United States District Court for the Northern District of California, which has vacated the “significant portion” part of the Services' SPR Policy (Desert Survivors, et al. v. U.S. Department of the Interior, et al., No. 16-cv-01165-JCS (Northern District of California, Aug. 24, 2018)). The procedure for analyzing whether any portion is an SPR is similar, regardless of the type of status determination we are making. The first step in our analysis of the status of a species is to determine its status throughout all of its range. If we determine that the species is in danger of extinction, or likely to become so in the foreseeable future, throughout all of its range, we list the species as an endangered (or threatened) species, and no SPR analysis will be required.

    When we conduct an SPR analysis, we first identify any portions of the species' range that warrant further consideration. The range of a species can theoretically be divided into portions in an infinite number of ways. However, there is no purpose in analyzing portions of the range that are not reasonably likely to be significant and either in danger of extinction or likely to become so in the foreseeable future. To identify only those portions that warrant further consideration, we determine whether there is substantial information indicating that (1) the portions may be significant and (2) the species may be in danger of extinction in those portions or likely to become so within the foreseeable future. We emphasize that answering these questions in the affirmative is not a determination that the species is in danger of extinction or likely to become so in the foreseeable future throughout a significant portion of its range—rather, it is a step in determining whether a more detailed analysis of the issue is required. In practice, a key part of this analysis is whether the threats are geographically concentrated in some way. If the threats to the species are affecting it uniformly throughout its range, no portion is likely to warrant further consideration. Moreover, if any concentration of threats applies only to portions of the range that clearly do not meet the biologically based definition of “significant” (i.e., the loss of that portion clearly would not be expected to increase the vulnerability to extinction of the entire species), those portions will not warrant further consideration.

    If we identify any portions that may be both (1) significant and (2) in danger of extinction or likely to become so in the foreseeable future, we engage in a more detailed analysis to determine whether both of these standards are indeed met. The identification of an SPR does not create a presumption, prejudgment, or other determination as to whether the species in that identified SPR is in danger of extinction or likely to become so in the foreseeable future. We must go through a separate analysis to determine whether the species is in danger of extinction or likely to become so in the foreseeable future in the SPR. To determine whether a species is in danger of extinction or likely to become so in the foreseeable future throughout an SPR, we will use the same standards and methodology that we use to determine if a species is in danger of extinction or likely to become so in the foreseeable future throughout its range.

    Depending on the biology of the species, its range, and the threats it faces, it may be more efficient to address the “significant” question first, or the status question first. Thus, if we determine that a portion of the range is not “significant,” we do not need to determine whether the species is in danger of extinction or likely to become so in the foreseeable future. If we determine that the species is not in danger of extinction or likely to become so in the foreseeable future in a portion of its range, we do not need to determine if that portion is “significant.”

    Applying the process described above, to identify whether any portions warrant further consideration for Deseret milkvetch, we determine whether there is substantial information indicating that (1) particular portions may be significant and (2) the species may be in danger of extinction in those portions or likely to become so within the foreseeable future. To identify portions that may be significant, we consider whether any natural divisions within the range might be of biological or conservation importance. To identify portions where the species may be in danger of extinction or likely to become so in the foreseeable future, we consider whether the threats are geographically concentrated in any portion of the species' range.

    We evaluated the range of Deseret milkvetch to determine if any area may be a significant portion of the range. Based on the small range of Deseret milkvetch—approximately 345 ac (140 ha) in an area 2.8 mi (4.5 km) by 0.3 mi (0.5 km)—we determined that the species is a single, contiguous population and that no separate areas of the range are significantly different from others or likely to be of greater biological or conservation importance than any other areas due to natural biological reasons alone. Therefore, there is not substantial information that logical, biological divisions exist within the species' range.

    After determining no natural biological divisions are delineating separate portions of the Deseret milkvetch population, we next examined whether any threats are geographically concentrated in some way that would indicate the species could be in danger of extinction, or likely to become so, in that area. There is some difference in livestock grazing between State and private lands, with little or no grazing on the 67 percent of habitat occurring on State lands and occasional potential grazing on the remaining private lands. However, steep topography limits grazing everywhere, and no fences are separating State and private lands (U.S. Fish and Wildlife Service 2011, p. 17). We have reviewed other potential threats and conclude that none of them is concentrated in any portion of the species' range to affect the representation, redundancy, or resiliency of the species.

    We did not identify any portions of the species' range that are likely to be both significant and in danger of extinction or likely to become so in the foreseeable future. Therefore, no portion warrant further consideration to determine whether the species is in danger of extinction or likely to become so in the foreseeable future in a significant portion of its range. We conclude that the species is, therefore, not an endangered species or threatened species based on its status in a significant portion of its range.

    Determination of Status

    We have carefully assessed the best scientific and commercial information available regarding the past, present, and future threats to Deseret milkvetch. After review and analysis of the information regarding stressors as related to the five statutory factors, we find that the ongoing stressors are not of sufficient imminence, intensity, or magnitude to indicate that this species is presently in danger of extinction throughout all or a significant portion of its range. Additionally, no threats exist currently, nor are any potential stressors expected to rise to the level that would likely cause the species to become in danger of extinction in the foreseeable future, throughout all or a significant portion of the species' range. Because the species is not in danger of extinction now or the foreseeable future throughout all of its range or any significant portion of its range, it does not meet the definition of an endangered species or threatened species. Therefore we find that Deseret milkvetch no longer requires the protection of the Act, and we are removing the species from the List of Endangered and Threatened Plants.

    Effects of the Rule

    This final rule revises 50 CFR 17.12(h) by removing Deseret milkvetch from the Federal List of Endangered and Threatened Plants. The prohibitions and conservation measures provided by the Act, particularly through sections 7 and 9, no longer apply to this species. Federal agencies will no longer be required to consult with the Service under section 7 of the Act in the event that activities they authorize, fund, or carry out may affect Deseret milkvetch. There is no critical habitat designated for this species; therefore, this rule does not affect 50 CFR 17.96.

    Post-Delisting Monitoring

    Section 4(g)(1) of the Act requires us, in cooperation with the States, to implement a monitoring program for not less than five years for all species that have been delisted due to recovery. The purpose of this requirement is to verify that a species remains secure from risk of extinction after it has been removed from the protection of the Act. The monitoring is designed to detect the failure of any delisted species to sustain itself without the protective measures provided by the Act. If at any time during the monitoring period, data indicate that protective status under the Act should be reinstated, we can initiate listing procedures, including, if appropriate, emergency listing under section 4(b)(7) of the Act. Section 4(g) of the Act explicitly requires us to cooperate with the States in development and implementation of post-delisting monitoring programs, but we remain responsible for compliance with section 4(g) of the Act and, therefore, must remain actively engaged in all phases of post-delisting monitoring. We also seek active participation of other entities that are expected to assume responsibilities for the species' conservation post-delisting.

    We are delisting Deseret milkvetch based on new information we have received as well as recovery actions taken. Since delisting will be due in part to recovery, we have prepared the post-delisting monitoring (PDM) plan for Deseret milkvetch. The PDM plan was prepared in coordination with the Utah Department of Natural Resources (UDNR) and UDWR. Monitoring will be a joint effort between UDNR and the Service. The PDM plan discusses the current status of the species and describes the methods proposed for monitoring if the species is removed from the Federal List of Endangered and Threatened Plants. Monitoring will occur annually for at least five years, beginning in 2019. At the end of 5 years, the species' population status will be evaluated, with three possible outcomes: (1) If the population is stable or increasing with no new or increasing stressors, PDM will conclude; (2) if the population is decreasing, but may be correlated with precipitation levels and remains above 20,000 plants on the WMA, PDM will be extended for an additional 3 to 5 years and then the population status will be reevaluated; or (3) if the population is decreasing without correlation to precipitation levels, and fewer than 20,000 plants exist on the WMA, a formal status review will be initiated.

    A final PDM plan is available (see ADDRESSES). We will work closely with our partners to maintain the recovered status of Deseret milkvetch and ensure post-delisting monitoring is conducted and future management strategies are implemented (as necessary) to benefit Deseret milkvetch.

    Required Determinations National Environmental Policy Act

    We have determined that we do not need to prepare an environmental assessment or environmental impact statement, as defined under the authority of the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq.), in connection with regulations pursuant to section 4(a) of the Act. We published a notice outlining our reasons for this determination in the Federal Register on October 25, 1983 (48 FR 49244).

    Government-to-Government Relationship With Tribes

    In accordance with the President's memorandum of April 29, 1994, Government-to-Government Relations with Native American Tribal Governments (59 FR 22951), E.O. 13175, and the Department of the Interior's manual at 512 DM 2, we readily acknowledge our responsibility to communicate meaningfully with recognized Federal Tribes on a government-to-government basis. In accordance with Secretarial Order 3206 of June 5, 1997 (American Indian Tribal Rights, Federal-Tribal Trust Responsibilities, and the Endangered Species Act), we readily acknowledge our responsibilities to work directly with Tribes in developing programs for healthy ecosystems, to acknowledge that tribal lands are not subject to the same controls as Federal public lands, to remain sensitive to Indian culture, and to make information available to Tribes. We have determined that no Tribes will be affected by this rule because no tribal lands are within or adjacent to Deseret milkvetch habitat.

    References Cited

    A complete list of all references cited in this final rule is available at http://www.regulations.gov under Docket No. FWS-R6-ES-2016-0013, or upon request from the Utah Ecological Services Field Office (see FOR FURTHER INFORMATION CONTACT).

    Authors

    The primary authors of this final rule are staff members of the Service's Mountain-Prairie Region and the Utah Ecological Services Field Office.

    List of Subjects in 50 CFR Part 17

    Endangered and threatened species, Exports, Imports, Reporting and recordkeeping requirements, Transportation.

    Regulation Promulgation

    Accordingly, we amend part 17, subchapter B of chapter I, title 50 of the Code of Federal Regulations, as set forth below:

    PART 17—ENDANGERED AND THREATENED WILDLIFE AND PLANTS 1. The authority citation for part 17 continues to read as follows: Authority:

    16 U.S.C. 1361-1407; 1531-1544; and 4201-4245, unless otherwise noted.

    § 17.12 [Amended]
    2. Amend § 17.12(h) by removing the entry for “Astragalus desereticus” under FLOWERING PLANTS from the List of Endangered and Threatened Plants. Dated: August 22, 2018. James W. Kurth, Deputy Director, U.S. Fish and Wildlife Service, Exercising the Authority of the Director, U.S. Fish and Wildlife Service.
    [FR Doc. 2018-22718 Filed 10-17-18; 8:45 am] BILLING CODE 4333-15-P
    83 202 Thursday, October 18, 2018 Proposed Rules ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2018-0577; FRL-9984-21] Receipt of Several Pesticide Petitions Filed for Residues of Pesticide Chemicals in or on Various Commodities AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice of filing of petitions and request for comment.

    SUMMARY:

    This document announces the Agency's receipt of several initial filings of pesticide petitions requesting the establishment or modification of regulations for residues of pesticide chemicals in or on various commodities.

    DATES:

    Comments must be received on or before November 19, 2018.

    ADDRESSES:

    Submit your comments, identified by the docket identification (ID) number and the pesticide petition number (PP) of interest as shown in the body of this document, by one of the following methods:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.

    Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001.

    Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html.

    Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.

    FOR FURTHER INFORMATION CONTACT:

    Michael Goodis, Registration Division (7505P), main telephone number: (703) 305-7090, email address: [email protected]; or Robert McNally, Biopesticides and Pollution Prevention Division (7511P), main telephone number: (703) 305-7090, email address: [email protected] The mailing address for each contact person is: Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001. As part of the mailing address, include the contact person's name, division, and mail code. The division to contact is listed at the end of each pesticide petition summary.

    SUPPLEMENTARY INFORMATION:

    I. General Information A. Does this action apply to me?

    You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

    • Crop production (NAICS code 111).

    • Animal production (NAICS code 112).

    • Food manufacturing (NAICS code 311).

    • Pesticide manufacturing (NAICS code 32532).

    If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT for the division listed at the end of the pesticide petition summary of interest.

    B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

    2. Tips for preparing your comments. When preparing and submitting your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

    3. Environmental justice. EPA seeks to achieve environmental justice, the fair treatment and meaningful involvement of any group, including minority and/or low-income populations, in the development, implementation, and enforcement of environmental laws, regulations, and policies. To help address potential environmental justice issues, the Agency seeks information on any groups or segments of the population who, as a result of their location, cultural practices, or other factors, may have atypical or disproportionately high and adverse human health impacts or environmental effects from exposure to the pesticides discussed in this document, compared to the general population.

    II. What action is the Agency taking?

    EPA is announcing its receipt of several pesticide petitions filed under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, requesting the establishment or modification of regulations in 40 CFR part 180 for residues of pesticide chemicals in or on various food commodities. The Agency is taking public comment on the requests before responding to the petitioners. EPA is not proposing any particular action at this time. EPA has determined that the pesticide petitions described in this document contain the data or information prescribed in FFDCA section 408(d)(2), 21 U.S.C. 346a(d)(2); however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the pesticide petitions. After considering the public comments, EPA intends to evaluate whether and what action may be warranted. Additional data may be needed before EPA can make a final determination on these pesticide petitions.

    Pursuant to 40 CFR 180.7(f), a summary of each of the petitions that are the subject of this document, prepared by the petitioner, is included in a docket EPA has created for each rulemaking. The docket for each of the petitions is available at http://www.regulations.gov.

    As specified in FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), EPA is publishing notice of the petitions so that the public has an opportunity to comment on these requests for the establishment or modification of regulations for residues of pesticides in or on food commodities. Further information on the petitions may be obtained through the petition summaries referenced in this unit.

    A. Amended Tolerance For Inerts

    PP IN-11139. (EPA-HQ-OPP-2018-0243). Monsanto Company, 1300 I Street, NW, Washington, DC 20005, requests to amend tolerances 40 CFR 180.471 for residues of furilazole (3-dichloroacetyl-5-(2-furanyl)-2,2-dimethyloxazolidine; CAS Reg. No. 121776-33-8) when used as an inert ingredient (herbicide safener) in or on the raw agricultural commodities corn, sweet, forage at 0.01 ppm, corn, sweet, kernel plus cob with husks removed at 0.01 parts per million (ppm), and, corn, sweet, stover at 0.01 ppm. The gas liquid chromatography/mass spectrometry with selected ion monitoring method is used to measure and evaluate the chemical furilazole. Contact: RD.

    B. Amended Tolerances for Non-Inerts

    1. PP 8E8684. (EPA-HQ-OPP-2018-0514). Interregional Research Project Number 4 (IR-4), Rutgers, The State University of New Jersey, 500 College Road East, Suite 201W, Princeton, NJ 08540, proposes upon establishment of the tolerances referenced in this document under “New Tolerances” for PP 8E8684, to remove existing tolerances in 40 CFR 180.585 for residues of the herbicide pyraflufen-ethyl, ethyl 2-[2-chloro-5-(4-chloro-5-difluoromethoxy)-1-methyl-1H-pyrazol-3-yl]-4-fluorophenoxy] acetate, and its acid metabolite, E-1, 2-chloro-5-(4-chloro-5-difluoromethoxy-1-methyl-1H-pyrazol-3-yl)-4-fluorophenoxyacetic acid, calculated as the stoichiometric equivalent of pyraflufen-ethyl in or on cotton, undelinted seed at 0.04 ppm; fruit, stone, group 12 at 0.01 ppm; grape at 0.01 ppm; nut, tree, group 14 at 0.01 ppm; olive at 0.01 ppm; and pistachio at 0.01 ppm. Contact: RD.

    2. PP 8E8689. (EPA-HQ-OPP-2018-0560). IR-4, Rutgers, The State University of New Jersey, 500 College Road East, Suite 201W, Princeton, NJ 08540, proposes upon establishment of the tolerances referenced in this document under “New Tolerances” for PP 8E8689, to remove existing tolerances in 40 CFR 180.553 for residues of the fungicide fenhexamid (N-2,3-dichloro-4-hydroxyphenyl)-1-methyl cyclohexanecarboxamide in or on the raw agricultural commodities: Bushberry subgroup 13B at 5.0 ppm; caneberry subgroup 13A at 20.0 ppm, cilantro, leaves at 30.0 ppm, fruit, stone, group 12, except plum, prune, fresh, postharvest at 10.0 ppm; grape at 4.0 ppm; juneberry at 5.0 ppm; kiwifruit, postharvest at 15.0 ppm; leafy greens subgroup 4A, except spinach at 30.0 ppm; lingonberry at 5.0 ppm; salal at 5.0 ppm; strawberry at 3.0 ppm; and vegetable, fruiting, group 8, except nonbell pepper at 2.0 ppm. The “Method for the Determination of KBR 2738 (TM-402) Residues in Plant Material by HPLC” is used to measure and evaluate the chemical fenhexamid. Contact: RD.

    C. New Tolerance Exemptions for Inerts (Except PIPs)

    1. IN-11109. (EPA-HQ-OPP-2018-0201). Exponent, Inc. (1150 Connecticut Ave, Suite 1100, NW, Washington, DC 20036) on behalf of Croda, Inc. (315 Cherry Lane, New Castle, DE 19720) requests to establish an exemption from the requirement of a tolerance for residues of C1-C4 linear and branched chain alkyl d-glucitol dianhydro alkyl ethers (C1-C4 Linear and Branched Chain AD-GDAE) cluster (D-glucitol, 1,4:3,6-dianhydro-2,5-di-O-methyl-(CAS Reg. No. 5306-85-4), D-glucitol, 1,4:3,6-dianhydro-2,5-di-O-ethyl- (CAS Reg. No. 30915-81-2), D-glucitol, 1,4:3,6-dianhydro-2,5-di-O-propyl) (CAS Reg. No.107644-13-3), D-glucitol, 1,4:3,6-dianhydro-2,5-bis-O-(1-methylethyl)-,(iso-propyl diether) (CAS Reg. No. 103594-41-8), D-glucitol, 1,4:3,6-dianhydro-2,5-di-O-butyl-(CAS Reg. No. 103594-41-9), D-glucitol, 1,4:3,6-dianhydro-2,5-di-O-(1-methylpropyl)-, (CAS Reg. No. not assigned) and D-glucitol, 1,4:3,6-dianhydro-2,5-di-O-(2-methylpropyl)-, (CAS Reg. No. not assigned) when used as an inert ingredient (solvent, co-solvent, viscosity modifier and adjuvant) in pesticide formulations applied to growing crops and raw agricultural commodities after harvest under 40 CFR 180.910, applied in/on animals under 40 CFR 180.930, in antimicrobial formulations used in food contact surfaces in public eating places, dairy processing equipment, and food-processing equipment and utensils under 40 CFR 180.940(a) and in antimicrobial formulations used for dairy processing equipment, and food-processing equipment and utensils under 40 CFR 180.940(b). The petitioner believes no analytical method is needed because it is not required for an exemption from the requirement of a tolerance. Contact: RD.

    2. PP IN-11126. (EPA-HQ-OPP-2018-0191). Spring Trading Company on behalf of Clariant, 4000 Monroe Rd., Charlotte, NC 28205, requests to establish an exemption from the requirement of a tolerance for residues of N,N-Dimethylnonanamide (CAS Reg. No. 6225-08-7) when used as a pesticide inert ingredient in pesticide formulations applied to growing crops and raw agricultural commodities after harvest under 40 CFR 180.910 and in pesticide formulations applied to animals under 40 CFR 1280.930. The petitioner believes no analytical method is needed because it is not required for an exemption from the requirement of a tolerance. Contact: RD.

    3. PP IN-11175. (EPA-HQ-OPP-2018-0545). SciReg, Inc., 12733 Director's Loop, Woodbridge, VA 22192, on behalf of Eden Research plc, 6 Priory Court, Priory Court Business Park, Poulton, Cirencester GL7 5JB, United Kingdom, requests to establish an exemption from the requirement of a tolerance for residues of cell walls of Saccharomyces cerevisiae when used as a pesticide inert ingredient in pesticide formulations applied to growing crops only under 40 CFR 180.920. The petitioner believes no analytical method is needed because it is not required for an exemption from the requirement of a tolerance. Contact: RD.

    4. PP IN-11189. (EPA-HQ-OPP-2018-0546). Keller and Heckman LLP, 1001 G Street, NW, Suite 500 West, Washington, DC 20001, on behalf of Synthomer USA LLC, requests to establish an exemption from the requirement of a tolerance for residues of Polyvinyl acetate—polyvinyl alcohol copolymer (CAS Reg. No. 25213-24-5) when used as a pesticide inert ingredient in pesticide formulations under 40 CFR 180.960. The petitioner believes no analytical method is needed because it is not required for an exemption from the requirement of a tolerance. Contact: RD.

    D. New Tolerances for Non-Inerts

    1. PP 8E8684. (EPA-HQ-OPP-2018-0514). IR-4, Rutgers, The State University of New Jersey, 500 College Road East, Suite 201W, Princeton, NJ 08540, requests to establish tolerances in 40 CFR part 180.585 for residues of the herbicide pyraflufen-ethyl, including its metabolites and degradates in or on the raw agricultural commodities (RACs). Compliance with the plant commodity tolerance levels specified below is to be determined by measuring only the sum of the parent pyraflufen-ethyl, ethyl 2-[2-chloro-5-(4-chloro-5-difluoromethoxy)-1-methyl-1H-pyrazol-3-yl]-4-fluorophenoxy] acetate, and its acid metabolite, E-1, 2-chloro-5-(4-chloro-5-difluoromethoxy-1-methyl-1H-pyrazol-3-yl)-4-fluorophenoxyacetic acid, calculated as the stoichiometric equivalent of pyraflufen-ethyl in or on the following RACs: Cottonseed subgroup 20C at 0.04 ppm; fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13-07F at 0.01 ppm; fruit, stone, group 12-12 at 0.01 ppm; hop, dried cones at 0.02 ppm; nut, tree, group 14-12 at 0.01 ppm; tropical and subtropical, small fruit, edible peel, subgroup 23A at 0.01 ppm; and vegetable, tuberous and corm, subgroup 1C at 0.02 ppm. Available analytical methodology involves multiple-step extractions of the chemical residues from plants and using Gas Chromatograph-Mass Spectrometry (GC-MS) to measure and evaluate pyraflufen-ethyl residues. Contact: RD.

    2. PP 8E8689. (EPA-HQ-OPP-2018-0560). IR-4, Rutgers, The State University of New Jersey, 500 College Road East, Suite 201W, Princeton, NJ 08540, requests to establish tolerances in 40 CFR part 180.553 for residues of the fungicide fenhexamid (N-2,3-dichloro-4-hydroxyphenyl)-1-methyl cyclohexanecarboxamide in or on the raw agricultural commodities: Arugula at 30.0 ppm; berry, low growing, subgroup 13-07G at 3.0 ppm; bushberry subgroup 13-07B at 5.0 ppm; caneberry subgroup 13-07A at 20.0 ppm; fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13-07F at 4.0 ppm; fruit, stone, group 12-12, except plum, prune, fresh, postharvest at 10.0 ppm; garden cress at 30.0 ppm; kiwifruit, fuzzy at 30.0 ppm; leafy greens subgroup 4-16A, except spinach at 30.0 ppm; onion, bulb, subgroup 3-07A at 2.0 ppm; onion, green, subgroup 3-07B at 30.0 ppm; upland cress at 30.0 ppm; and vegetable, fruiting, group 8-10, except nonbell pepper at 2.0 ppm. The “Method for the Determination of KBR 2738 (TM-402) Residues in Plant Material by HPLC” is used to measure and evaluate the chemical fenhexamid. Contact: RD.

    Authority:

    21 U.S.C. 346a.

    Dated: October 1, 2018. Delores Barber, Director, Information Technology and Resources Management Division, Office of Pesticide Programs.
    [FR Doc. 2018-22659 Filed 10-17-18; 8:45 am] BILLING CODE 6560-50-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 42 CFR Part 403 [CMS-4187-P] RIN 0938-AT87 Medicare and Medicaid Programs; Regulation To Require Drug Pricing Transparency AGENCY:

    Centers for Medicare & Medicaid Services (CMS), HHS.

    ACTION:

    Proposed rule.

    SUMMARY:

    This proposed rule would revise the Federal Health Insurance Programs for the Aged and Disabled by amending the Medicare Parts A, B, C and D programs, as well as the Medicaid program, to require direct-to-consumer (DTC) television advertisements of prescription drugs and biological products for which payment is available through or under Medicare or Medicaid to include the Wholesale Acquisition Cost (WAC, or “list price”) of that drug or biological product. We are proposing this regulation to improve the efficient administration of the Medicare and Medicaid programs by ensuring that beneficiaries are provided with relevant information about the costs of prescription drugs and biological products so they can make informed decisions that minimize not only their out-of-pocket costs, but also expenditures borne by Medicare and Medicaid, both of which are significant problems.

    DATES:

    To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on December 17, 2018.

    ADDRESSES:

    In commenting, please refer to file code CMS-4187-P. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission. Comments, including mass comment submissions, must be submitted in one of the following three ways (please choose only one of the ways listed):

    1. Electronically. You may submit electronic comments on this regulation to http://www.regulations.gov. Follow the “Submit a comment” instructions.

    2. By regular mail. You may mail written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-4187-P, P.O. Box 8013, Baltimore, MD 21244-8013.

    Please allow sufficient time for mailed comments to be received before the close of the comment period.

    3. By express or overnight mail. You may send written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-4187-P, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.

    For information on viewing public comments, see the beginning of the SUPPLEMENTARY INFORMATION section.

    FOR FURTHER INFORMATION CONTACT:

    Cheri Rice, (410) 786-6499.

    SUPPLEMENTARY INFORMATION:

    Inspection of Public Comments: All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following website as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that website to view public comments.

    I. Background A. Purpose

    The purpose of this proposed rule is to reduce the price to consumers of prescription drugs and biological products. This rule would require direct-to-consumer (DTC) television advertisements for prescription drug and biological products for which reimbursement is available, directly or indirectly, through or under Medicare or Medicaid to include the list price of that product. We are proposing this regulation to improve the efficient administration of the Medicare and Medicaid programs by ensuring that beneficiaries are provided with relevant information about the costs of prescription drugs and biological products so they can make informed decisions that minimize not only their out-of-pocket costs, but also unreasonable expenditures borne by Medicare and Medicaid, both of which are significant problems.

    Markets operate more efficiently when consumers have relevant information about a product, including its price, as well as alternative products and their prices, before making an informed decision whether to buy that product or, instead, a competing one. Consumers price shop when looking to purchase a new car, a new house, or even a new coffee maker. Price shopping is the mark of rational economic behavior. To facilitate price shopping, sellers invariably provide potential buyers with the prices of their products; consumers gauge the reasonableness of these prices against alternatives. Even automobile dealerships, as result of federal law, post the retail or “sticker” price on the side window of each new car offered for sale.

    That has not been the case with prescription drugs or biological products, where consumers often need to make decisions without information about a product's price. Price transparency is a necessary element of an efficient market that allows consumers to make informed decisions when presented with relevant information, but for consumers of prescription drugs, including those whose drugs are covered through Medicare or Medicaid, both the list price and actual price to the consumer remain hard to find. Third-party payment, a dominant feature of health care markets, is not a prominent feature of other markets and causes distortions, such as an absence of meaningful prices and the information and incentives that prices provide. In many cases prescription drug coverage is provided by an employer to its employees, or by the federal government to Medicare and Medicaid beneficiaries. These entities providing prescription drug coverage are known as payors.

    List price plays a role in negotiations between payors, Pharmacy Benefit Managers (PBMs), and manufacturers, which all impact beneficiary cost sharing. Payors hire third party providers such as PBMs to manage the payor's prescription drug benefit for the payor's employees and negotiate improved drug pricing for medications based on the level of utilization management a payor is willing to apply to the benefit. Prescription drug benefit designs are typically based on the manufacturer's list price, however, in many cases the PBM can negotiate a lower price than a manufacturer's list price if there is high deductible plans, copay or coinsurance, formulary either tiered or closed, utilization management including step therapy and prior authorizations. The willingness of a payor to apply varying degrees of utilization control impacts savings for each individual payor and beneficiary. A PBM could have ten different clients with ten different benefit designs and it would be possible that an employee from each client could get the exact same product and all ten could pay a different price.

    A number of factors make list price relevant across a variety of drug benefit designs, even though the PBM may have negotiated a lower price for the product dispensed to the beneficiary. First, in the commercial market, over 40% of beneficiaries are in high deductible plans. Under such plans, beneficiaries pay the full list price of the product until they meet their deductible, which can be thousands of dollars. Second, benefit designs are built off of list price, because the negotiated rebate rate is not paid until months after the product was dispensed. Third, co-insurance has become a standard payor mechanism applicable to high cost drugs, requiring the patient to pay a percentage of the list price. All of the top 10 PDPs use coinsurance rather than fixed dollar copayments for medications on nonpreferred drug tiers, charging 30 percent to 50 percent of each prescription's full price in 2017.1 Finally, very few drugs have coverage on all the formularies in the country. If a plan does not cover a particular drug requested by a patient, then the patient may have to pay the full list price to access the medication.

    1 MEDPAC Report to the Congress: Medicare Payment Policy. March 2017. 383.

    Due at least in part to the market-distorting effects of third-party payors, pharmaceutical manufacturers tend not to compete based on list price, and hence there is little to no market pressure voluntarily to disclose a product's list price. Not only does transparency promote a more competitive environment, but data indicate that it will likely motivate manufacturers to be less willing to raise prices, which have dramatically increased over the past decade. See, e.g., John F. Cady, “An Estimate of the Price Effects of Restrictions on Drug Advertising,” 44 Economic Inquiry, 493-510 (Dec. 1976) (finding that prescription drug prices were 4.3% higher on average in states restricting advertising of prices than in states allowing such advertising.). While study results vary depending on the design, the population studied, and product at issue, according to the Congressional Research Service

    [m]ost research suggests that when better price information is available prices for goods sold to consumers fall. The largest and most straightforward body of evidence relates to the effect of advertising, where nearly all research indicates advertising prices is associated with lower prices. This reduction in prices suggests that advertising's increased information on prices and increases in competition outweigh any tendency to increase prices through increasing demand and brand identification.2

    2 D. Andrew Austin and Jane G. Gravelle, “Does Price Transparency Improve Market Efficiency? Implications of Empirical Evidence in Other Markets for the Health Sector, CRS Report 46 (July 24, 2007).

    This proposed rule seeks to fill this informational gap by adding a new subpart L to part 403 to title 42 that would require that for prescription drug and biological products that can be reimbursed directly or indirectly through or under Medicare or Medicaid, DTC ads on television (including broadcast, cable, streaming, and satellite communication) for such products must include the product's current list price, defined as the Wholesale Acquisition Cost.3 CMS is proposing this rule in the context of broadcast advertisements, an area in which the Supreme Court historically has recognized that the government may take special steps to help ensure that viewers receive appropriate information. See Red Lion Broad. Co. v. FCC, 395 U.S. 367, 390, 394 (1969) (“It is the right of the viewers and listeners, not the right of the broadcasters, which is paramount.”).

    3 Over-the-counter drugs covered by Medicaid, to the extent that they cost more than $35 per month, are not within the scope of this rule.

    B. Legal Authority

    HHS recognizes that “an administrative agency's power to regulate . . . must always be grounded in a valid grant of authority from Congress.” Food & Drug Admin. v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 161 (2000). Thus, in proposing new regulations HHS must pay close attention to the text and structure of the legislation granting an agency authority. “Agencies are . . . `bound, not only by the ultimate purposes Congress has selected, but by the means it has deemed appropriate, and prescribed, for the pursuit of those purposes.'” Colorado River Indian Tribes v. Nat'l Indian Gaming Comm'n, 466 F.3d 134, 139-40 (D.C. Cir. 2006) (quoting MCI Telecomms. Corp. v. AT&T, 512 U.S. 218, 231 n.4, (1994)). This proposed rule is issued pursuant to sections 1102 and 1871 of the Social Security Act. Section 1102(a) of the Social Security Act authorizes the Secretary to issue “such rules and regulations, not inconsistent with this Act, as may be necessary to the efficient administration of the functions . . . under this Act[,].” The Secretary has “broad rule-making authority” under section 1102, for both Medicare and Medicaid. See, e.g., Thorpe v. Housing Authority of City of Durham, 393 U.S. 268, 277 n.28 (1969). Under Section 1871(a), which instructs “[t]he Secretary [to] prescribe such regulations as may be necessary to carry out the administration of the insurance programs under this title [XVIII],” the Secretary similarly possesses broad rulemaking authority with respect to the Medicare program. See, e.g., Cottage Health Sys. v. Sebelius, 631 F. Supp. 2d 80, 92 (D.D.C. 2009). Rules issued under such broad rulemaking authorities must be “sustained so long as [they are] `reasonably related to the purposes of the enabling legislation.' ” and do not contradict or undermine that legislation. Mourning v. Family Publ'ns Servs., Inc., 411 U.S. 356, 369 (1973) (quoting Thorpe, 393 U.S. at 280-81).

    HHS has concluded that the proposed rule has a clear nexus to the Social Security Act. In numerous places in the Act, Congress recognized the importance of administering the Medicare and Medicaid programs in a manner that minimizes unreasonable expenditures. See, e.g., Sections 1842(b)(8) and (9), 1860D-4(c)(3), 1860D-4(c)(5)(H), 1866(j)(2)(A), 1893(g), 1902(a)(64), 1902(a)(65), 1936(b)(2). In addition, Congress recognized the value of disclosures about drug prices. In section 1927(b)(3)(A) of the Act, manufacturers with Part B rebate agreements must disclose pricing information to the government, including the average manufacturer price, the manufacturer's average sales price, and at times the manufacturer's wholesale acquisition cost as well as the manufacturer's best price for certain drugs. And in the Part D program, section 1860(k)(1) compels certain sponsors offering prescription drug plans to disclose the difference between the price of a dispensed drug and the price of the lowest priced generic available that is therapeutically equivalent and bioequivalent. This rule uses means that Congress has generally endorsed—disclosures about drug prices—to advance an end that Congress endorsed—minimizing unreasonable expenditures—and thus there is a clear nexus between HHS's proposed actions and the Act.

    In addition, although Congress has not explicitly provided HHS with authority to compel the disclosure of list prices to the public, Congress has explicitly directed HHS to operate Medicare and Medicaid programs efficiently. Promoting pricing transparency, and thus efficient markets, for drugs funded through those programs falls within the scope of that mandate. Drugs and biological products are covered under the Medicare Part B benefit (authorized by various provisions including sections 1832, 1861(s)(2) of the Social Security Act (the Act)), the Medicare Part D benefit (authorized by section 1860D-1 et seq. of the Act), and as part of hospital inpatient admissions under Medicare Part A's prospective payment system (authorized by Sections 1814, 1886 of the Act). The Medicaid drug benefit is authorized by sections 1902(a)(54) and 1905(a)(12).

    The Secretary has determined that the proposed regulation is necessary to the efficient administration of the Medicare and Medicaid programs. The Secretary has an obligation to ensure the wise expenditure of federal trust fund dollars, and may promulgate regulations to advance these goals. See, e.g., Sid Peterson Mem'l Hosp. v. Thompson, 274 F.3d 301, 313 (5th Cir. 2001); see also 42 U.S.C. 1395i (Medicare Part A trust fund); 42 U.S.C. 1395t (Medicare Parts B and D trust fund). Efficient administration of both Medicare and Medicaid encompasses federal efforts to achieve good value for funds spent in the Medicare and Medicaid programs. Toward that end, the agency has issued regulations that promote the responsible use of federal funds. See, e.g., 42 CFR part 413, subpart C (limitations on reasonable cost reimbursement), § 421.122 (oversight of contractors), § 424.5 (conditions for payment), § 438.4 et seq. (actuarial soundness of capitation rates). Nonetheless, the cost to the federal government, Medicare beneficiaries, and State Medicaid programs of prescription drugs and biological products has been increasing at an alarming rate due both to increasing prices and increasing utilization. See, e.g., https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/Information-on-Prescription-Drugs/. As discussed further below, DTC advertising without price transparency has a direct nexus to these trends of increasing price and utilization. This proposed regulation combats these trends by ensuring that beneficiaries are provided with relevant information about the costs of prescription drugs and biological products, so they can make informed decisions. Based on a combination of all of these reasons, the Act authorizes HHS to issue this proposed rule.

    C. The Cost of Prescription Pharmaceuticals to Medicare and Medicaid and Their Beneficiaries Has Been Rising Annually

    The cost of drugs and biological products over the past decade has increased dramatically, and are projected to continue to rise faster than overall health spending, thereby increasing this sector's share of health care spending. The HHS Office of the Assistant Secretary for Planning and Evaluation estimates that prescription drug spending in the United States was about $457 billion in 2015, or 16.7 percent of overall personal health care services. Of that $457 billion, $328 billion (71.9 percent) was for retail drugs and $128 billion (28.1 percent) was for non-retail drugs. Factors underlying the rise in prescription drug spending from 2010 to 2014 can be roughly allocated as follows: 10 percent of that rise was due to population growth; 30 percent to an increase in prescriptions per person; 30 percent to overall, economy-wide inflation; and 30 percent to either changes in the composition of drugs prescribed toward higher price products or price increases for drugs that together drove average price increases in excess of general inflation.4

    4 ASPE Issue Brief. Observations on Trends in Prescription Drug Spending. March 8, 2016.

    Manufacturers of prescription drugs in competitive classes often offer price concessions in the form of rebates that are paid after the prescription is filled. Manufacturer rebates have grown approximately 10% of gross Part D drug costs in 2008 to 20% of gross Part D drug costs in 2016. The CMS Office of the Actuary projects rebates will exceed 28% of gross Part D drug costs over the next ten years.5

    5 2018 ANNUAL REPORT OF THE BOARDS OF TRUSTEES OF THE FEDERAL HOSPITAL INSURANCE AND FEDERAL SUPPLEMENTARY MEDICAL INSURANCE TRUST FUNDS.

    Because the list price of a drug does not reflect manufacturer rebates paid to a PBM, insurer, health plan, or government program, obscuring these discounts can shift costs to consumers in commercial health plans and Medicare beneficiaries. Many incentives in the current system reward higher list prices, all participants in the chain of distribution, e.g., manufacturers, wholesalers, pharmacy benefit managers, and even private insurers, gain as the list price of any given drug increases. These financial gains come at the expense of increased costs to patients and public payors, such as Medicare and Medicaid, which ultimately fall on the backs of American taxpayers.

    Furthermore, consumers who have not met their deductible or are subject to coinsurance, pay based on the pharmacy list price, which is not reduced by the substantial drug manufacturer rebates paid to PBMs and health plans. As a result, the growth in list prices, and the widening gap between list and net prices, markedly increases consumer out-of-pocket spending, particularly for high-cost drugs not subject to negotiation.

    The Centers for Medicare & Medicaid Services (CMS) is the single largest drug payor in the nation. In 2016, CMS and its beneficiaries spent $174 billion on drugs covered under Parts B and D, and $64 billion on drugs covered under Medicaid. An additional sum was spent on drugs furnished by hospitals under Part A's inpatient prospective payment system, but the precise amount is difficult to isolate because hospitals receive a single payment for all non-physician services provided during an inpatient stay (including drugs). In 2016, CMS and its beneficiaries spent more than $238 billion on prescription drugs, approximately 53 percent of the $448.2 billion spent on retail and non-retail prescription drugs in the United States that year. Each year overall expenditures on drugs by both the Medicare and Medicaid programs and their beneficiaries have increased at rates greater than inflation both in the aggregate and on a per beneficiary basis.

    For Part D, according to the 2018 Trustees' Report, CMS's costs have grown,

    [o]ver the past 10 years, Part D benefit payments have increased by an annual rate of 7.4 percent in aggregate and by 3.8 percent on a per enrollee basis. These results reflect the rapid growth in enrollment, together with multiple prescription drug cost and utilization trends that have varying effects on underlying costs. For example, there has been a substantial increase in the proportion of prescriptions filled with low—cost generic drugs that has helped constrain cost growth, while there has also been a significant increase in the cost of specialty drugs that has increased cost growth.6

    6 2018 Annual Report of the Boards of Trustees of the Federal Hospital Insurance and Federal Supplementary Medical Insurance Trust Funds at 106, available at https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/ReportsTrustFunds/Downloads/TR2018.pdf.

    In other words, the per beneficiary cost of drugs through Part D has increased nearly 40% over the past decade, while the consumer price index has increased only 19% during this same period.7

    7https://data.bls.gov/pdq/SurveyOutputServlet?request_action=wh&graph_name=CU_cpibrief.

    Over the period 2013-2016, Medicare Parts D and B, and Medicaid expenditures on a per beneficiary basis increased by 22%, 32%, and 42% respectively. Drug price inflation accounts for some of this growth. Between 2006 and 2015, Part D brand drug prices rose by an average 66% cumulatively.8 Since 2009, Medicare Part B drug spending grew at an average rate of about 9% per year. About half of the growth in Part B drug spending between 2009 and 2013 was accounted for by price growth, which reflects increased prices for existing products and shifts in the mix of drugs, including the adoption of new drugs.9 Medicaid drug spending grew 25% in 2015 and 13% in 2015.10

    8 MEDPAC. Report to the Congress: Medicare Payment Policy. March 2018. 415.

    9 MEDPAC. Report to the Congress: Medicare and the Health Care Delivery System. June 2017. 37.

    10 CMS National Health Expenditure Data. 2016.

    Price transparency will help improve the efficiency of Medicare and Medicaid programs by reducing wasteful and abusive increases in drug and biological list prices—spiraling drug costs that are then passed on to federal healthcare program beneficiaries and American taxpayers more broadly. First, it will provide manufacturers with an incentive to reduce their list prices by exposing overly costly drugs to public scrutiny. Second, it will provide some consumers with more information to better position them as active and well-informed participants in their health care decision-making. As discussed further below, consumers make a series of critical health care decisions related to their treatment with prescription drugs, and the list price of those drugs may be informative to those decisions. Even where the consumer may be insured, and therefore will be paying substantially less than the list price, the coinsurance borne by some consumers will necessarily increase as the prices negotiated by PBMs increase.

    D. Direct-to-Consumer Advertising and Its Role, in Part, in Fueling the Demand for Higher Cost Drugs

    Prescription drugs, by definition, cannot be accessed directly by the consumer; they must be prescribed by a licensed health care practitioner. We know, however, that consumers are responsible for critical choices related to their treatment with prescription drugs. For example, consumers decide whether to make the initial appointment with a physician; whether to ask the physician about a particular drug or drugs; whether to fill a prescription; whether to take the drug; and whether to continue taking it in adherence to the prescribed regimen. Drug manufacturers, therefore, spend billions of dollars annually promoting their prescription drugs directly to consumers through television advertisements and other media. In 2017, over $5.5 billion was spent on prescription drug advertising, including nearly $4.2 billion on television advertising.11

    11 Kantar Media Advertising Intelligence—2013 to 2017 Prescription Medications Ad Spend Data.

    DTC advertising appears to directly affect drug utilization.12 Studies show how consumers exposed to drug advertisements can exert sufficient pressure on their physicians to prescribe the advertised product.13 In one recent survey, one in eight adults (12%) said they were prescribed a specific drug after asking a doctor about it as a result of seeing or hearing an advertisement.14 When manufacturers direct their DTC advertising to consumers, such messaging can help facilitate more informed discussions between consumers and their health care providers in making decisions about treatment. But it can also result in increased utilization through patients demanding costly drugs and biological products based on advertising messaging, with a resulting increase in government spending—a problem if less costly alternatives are available, or would be available through market pressures resulting from greater price transparency.

    12 Dhaval Dave & Henry Saffer, Impact of Direct-to-Consumer Advertising on Pharmaceutical Prices and Demand, 79 Southern Economic Journal 97-126 (2012); Balaji Datti & Mary W. Carter, The Effect of Direct-to-Consumer Advertising on Prescription Drug Use by Older Adults, 23 Drugs Aging 71-81 (2006).

    13 Barbara Mintzes et al., Influence of direct to consumer pharmaceutical advertising and patients' requests on prescribing decisions: Two site cross sectional survey, 324 The BMJ 278-79 (2002).

    14 Kaiser Health Tracking Poll (October 2015) https://www.kff.org/health-costs/poll-finding/kaiser-health-tracking-poll-october-2015/.

    To have the necessary information in making critical decisions related to prescription drugs, consumers need some idea of the magnitude of the cost of the advertised drug. More informed consumer decision making will impact not only each individual beneficiary's own finances, but also positively affect the shared taxpayer responsibility to fund the Medicare and Medicaid drug benefit programs.

    E. Transparency in Drug Pricing Promotes Lower Prices and More Informed Purchasing by Beneficiaries

    Both Titles XVIII and XIX of the Act reflect the importance of administering the Medicare and Medicaid programs in a manner that minimizes unreasonable expenditures. See, e.g., Sections 1842(b)(8) and (9), 1860D-4(c)(3), 1860D-4(c)(5)(H), 1866(j)(2)(A), 1893(g), 1902(a)(64), 1902(a)(65), 1936(b)(2). In order to enable consumers to make good health care choices, which will in turn improve the efficiency of the Medicare and Medicaid programs, it is critical that they understand the costs associated with various medications. This is especially important where consumers have cost sharing obligations that may be significant.

    As discussed above, DTC advertisements that do not provide pricing information may contribute to rising drug prices and rising premiums. Consumers of pharmaceuticals are currently missing information that consumers of other products can more readily access, namely the list price of the product, which acts as a point of comparison when judging the reasonableness of prices offered for potential substitute products. In an age where price information is ubiquitous, the prices of pharmaceuticals remain shrouded and limited to those who subscribe to expensive drug price reporting services.

    Consumers may be able to obtain some pricing information by going on-line to the websites of larger chain pharmacies. However, there are several reasons consumers are not likely to do this. First, while consumers make many critical decisions that bring about the ultimate writing of the prescription—making the appointment, asking the doctor about particular drugs, etc.—the physician, rather than the patient, ultimately controls the writing of the prescription, and the patient may not even know exactly which drug is prescribed. Second, meaningful price shopping is further hindered because the average consumer has no anchor price, such as an MSRP for automobiles, to gauge the reasonableness of the various price quotes.

    Arming a beneficiary with basic price information will provide him or her with an anchor price, in other words, a reference comparison to be used when making decisions about therapeutic options. Triggering conversations about a particular drug or biological and its substitutes may lead to conversations not only about price, but also efficacy and side effects, which in turn may cause both the consumer and the prescriber to consider the cost of various alternatives (after taking into account the safety, efficacy, and advisability of each treatment for the particular patient). Ultimately, providing consumers with basic price information may result in the selection of lesser cost alternatives, all else being equal relative to the patient's care. We seek comment on how providing consumers with the list price of a medication may influence interactions with prescribers, the selection of drug products, and the perceived efficacy of the prescribed drug. We also seek comment about how benefit design influences these choices.

    Requiring DTC television ads to disclose pricing information to consumers, as proposed in this rule, is consistent with First Amendment jurisprudence. Rules, such as this one, that require certain factual commercial disclosures pass muster under the First Amendment where the disclosure advances a government interest and does not unduly burden speech.

    When the government requires accurate disclosures in the marketing of regulated products under appropriate circumstances, it does not infringe on protected First Amendment interests. As the United States Supreme Court recognized in Zauderer v. Office of Disciplinary Counsel, 471 U.S. 626 (1985) and recently confirmed in Nat'l Inst. of Family and Life Advocates v. Becerra, 138 S. Ct. 2361, 2372, 2376 (2018) (“NIFLA”), required disclosures of factual, noncontroversial information in commercial speech may be subject to more deferential First Amendment scrutiny. Under the approach articulated in Zauderer, courts have upheld required disclosures of factual information in the realm of commercial speech where the disclosure requirement reasonably relates to a government interest and is not unjustified or unduly burdensome such that it would chill protected speech. See Zauderer, 471 U.S. at 651; Milavetz v. United States, 559 U.S. 229, 250, 252-53 (2010); NIFLA, 138 S. Ct. at 2376 (“[W]e do not question the legality of . . . purely factual and uncontroversial disclosures about commercial products.”). In addition, the United States Supreme Court has long recognized that broadcast viewers and listeners have a significant First Amendment interest in receiving information about matters of public concern. See Red Lion Broad. Co. v. FCC, 395 U.S. 367, 390, 394 (1969).

    In this proposed rule, the required disclosure consists of purely factual and uncontroversial information about a firm's own product, namely the list price of the drug or biological product. The required disclosure here advances the government's substantial interest in the efficient administration of both Medicare and Medicaid programs by minimizing unreasonable expenditures. Increased price transparency will help reduce unreasonable expenditures associated with soaring drug costs by providing manufacturers with an incentive to reduce their list prices by exposing overly costly drugs compared to alternatives to public scrutiny, and providing consumers with price information to facilitate more informed health care decisions. See generally Pharm. Care Mgmt. Ass'n v. Rowe, 429 F.3d 294, 310 (1st Cir. 2005) (recognizing that the government interest in cost-effective health care justified disclosure of financial interests of pharmacy benefit managers); N.Y. State Rest. Ass'n v. N.Y. City Bd. of Health, 556 F.3d 114, 134 (2d Cir. 2009) (recognizing that the government interest in “promot[ing] informed consumer decision-making” justified posting of calories on menus in chain restaurants). Indeed, the United States Supreme Court has long recognized a strong societal interest in the free flow of information about prescription drug prices:

    Those whom the suppression of prescription drug price information hits the hardest are the poor, the sick, and particularly the aged. A disproportionate amount of their income tends to be spent on prescription drugs; yet they are the least able to learn, by shopping from pharmacist to pharmacist, where their scarce dollars are best spent. When drug prices vary as strikingly as they do, information as to who is charging what becomes more than a convenience. It could mean the alleviation of physical pain or the enjoyment of basic necessities.

    Va. State Bd. of Pharmacy v. Va. Citizens Consumer Council, 425 U.S. 748, 763-64 (1976).

    Furthermore, these price disclosures would neither “drown[ ] out the [speaker's] own message” or “effectively rule[ ] out” a mode of communication. NIFLA, 138 S. Ct. at 2378. Indeed, the requirement to add certain information to an advertisement is not unduly burdensome where, as here, the manufacturer has the ability to convey other information of its choosing in the remainder of the advertisement. See, e.g., Spirit Airlines, Inc. v. United States Dep't of Transp., 687 F.3d 403, 414 (D.C. Cir. 2012) (requirement for airlines to make total price the most prominent cost figure does not significantly burdens airlines' ability to advertise); Discount Tobacco City & Lottery, Inc. v. United States, 674 F.3d 509, 524 (6th Cir. 2012) (size of required warnings is not unduly burdensome where remaining portions of their packaging are available for other information). Indeed, there are many regulatory schemes that require the disclosure of price information to consumers. See 12 CFR 1026.33(b)(2) (2018) (mortgage lenders must disclose to consumers total annual loan cost rates for reverse mortgages); 12 CFR 226.18 (2018) (creditors must disclose to borrowers multiple terms including the annual percentage rate); 12 CFR 1030.4(a) and (b) (2018) (depository institutions must provide to a consumer, before an account is opened or service provided, account information including fixed or variable interest rates); Mass. Ann. Laws ch. 94 Section 295C (2018) (retail dealers of motor fuel must publicly display and maintain on each pump a sign on which the price per gallon per grade is clearly visible); Minn. Stat. Section 239.751 (2017) (retail dealers of petroleum must clearly display the price of per gallon and the price cannot be obscured in any way).15

    15 In addition, regulated entities are required to report price information to the government in a variety of settings. See, e.g., 7 CFR 59.301(a) and (b) (2018) (packer processing plants must daily report to the Secretary of Agriculture the sale price for lambs which the Secretary of Agriculture then makes public); 7 CFR 59.104(a)(1) (2018) (packer processing plants must report to the Secretary of Agriculture twice a day the sale price of each lot of “boxed beef” which the Secretary of Agriculture then makes public); 17 CFR 229.1204(b)(1) (2018) (oil and gas producers must report to the SEC the average sale price per unit of oil, gas, or other product by geographic area for three preceding fiscal years).

    II. Provisions of Proposed Regulation (§§ 403.1200, 403.1201, 403.1202, 403.1203, and 403.1204)

    As discussed at length above, we are proposing this regulation to improve the efficient administration of the Medicare and Medicaid programs by ensuring that beneficiaries are provided with relevant information about the costs of prescription drugs and biological products so they can make informed decisions that minimize not only their out-of-pocket costs, but also unreasonable Medicare and Medicaid expenditures, both of which are significant problems.

    Keeping these principles in mind, we are proposing to amend subchapter A, part 403 by adding a new subpart L. Proposed § 403.1202 sets forth the requirement that advertisements for certain prescription drug or biological products on television (including broadcast, cable, streaming, and satellite), must contain a statement or statements indicating the Wholesale Acquisition Cost (referred to as the “list price”) for a typical 30-day regimen or for a typical course of treatment, whichever is most appropriate, as determined on the first day of the quarter during which the advertisement is being aired or otherwise broadcast, as follows: “The list price for a [30-day supply of ] [typical course of treatment with] [name of prescription drug or biological product] is [insert list price]. If you have health insurance that covers drugs, your cost may be different.” Manufacturers set the Wholesale Acquisition Cost, also known as list price, for their products. The Department recognizes that other prices may be paid by distributors, pharmacies, patients, and others in the supply chain. Because these other prices vary by contracts established by payors or others, only the Wholesale Acquisition Cost is certain to be known by the manufacturer when creating DTC ads.

    The price stated in the advertisement must be current as of the date of publication or broadcast. This provision would specify that where the price is related to the “typical course of treatment,” and the course of treatment varies depending on the indication for which the drug is prescribed, the list price used should be the one for the “course of treatment” associated with the primary indication addressed in the advertisement. To the extent permissible under current laws, manufacturers would be permitted to include an up-to-date competitor product's list price, so long as they do so in a truthful, non-misleading way. In § 403.1200(b) we are proposing an exception to the requirement at proposed § 403.1202(a) to provide that an advertisement for any prescription drug or biological product and that has a list price, as defined herein, of less than $35 per month for a 30-day supply or typical course of treatment will be exempt from these transparency requirements.

    We are also proposing that § 403.1200 set forth the scope of applicability to specify that this requirement will apply to any advertisement for a prescription drug or biological product distributed in the United States, for which payment is available, directly or indirectly, under titles XVIII or XIX of the Social Security Act.

    We are further proposing in § 403.1203 that the required price disclosure set forth in proposed § 403.1202 be conveyed in a legible textual statement at the end of the advertisement, meaning that it is placed appropriately and is presented against a contrasting background for sufficient duration and in a size and style of font that allows the information to be read easily. We seek comment on whether the final rule should include more specific requirements with respect to the textual statement, such as specific text size, contrast requirements, and/or duration and specifically what those requirements should be.

    We are proposing in § 403.1204(a) that the Secretary shall maintain a public list that will include the drugs and biological products identified by the Secretary to be advertised in violation of this rule. We expect that this information will be posted publicly on a CMS internet website no less than annually. No other HHS-specific enforcement mechanism is proposed in this rule. However, we anticipate that the primary enforcement mechanism will be the threat of private actions under the Lanham Act Section 43(a), 15 U.S.C. 1125(a), for unfair competition in the form of false or misleading advertising. See, e.g., POM Wonderful LLC v. Coca-Cola Co., 134 S. Ct. 2228, 2234 (2014); In re McCormick & Co., Inc., Pepper Prod. Mktg. & Sales Practices Litig., 215 F. Supp. 3d 51, 59 (D.D.C. 2016). Since Lanham Act cases normally involve sophisticated parties doing business in the same sector, the likelihood of meritless lawsuits is acceptably low. We seek comment on the primary enforcement mechanism and other approaches to enforcing compliance.

    Under principles of implied preemption, to the extent State law makes compliance with both Federal law and State law impossible or would frustrate Federal purposes and objectives, the State requirement would be preempted. See, e.g., Murphy v. NCAA, 138 S. Ct. 1461, 1480-81 (2018); Mutual Pharm. Co. v. Bartlett, 570 U.S. 472, 480 (2013); Geier v. American Honda Motor Co., 529 U.S. 861, 872-86 (2000). Obstacle preemption is not limited to examining the accomplishment of certain objectives; the execution is relevant as well. Geier, 529 U.S. 881-82. A state law is therefore preempted “if it interferes with the methods by which the federal statute was designed to reach that goal.” Gade v. Nat'l Solid Wastes Mgmt. Ass'n, 505 U.S. 88, 103 (1992) (quoting Int'l Paper Co. v. Ouellette, 479 U.S. 481, 494 (1987)).

    Because this proposed rule is part of a broader initiative to reduce the price to consumers of prescription drugs and biological products, it would be counterproductive if this rule were to increase transactional costs in defending meritless litigation. We believe that the existing authority cited above, namely the Lanham Act, is the appropriate mechanism for enforcing against deceptive trade practices. Accordingly, consistent with our not including any HHS-specific enforcement mechanism in this proposal, we are proposing at § 403.1204(b) that this rule preempt any state-law-based claim which depends in whole or in part on any pricing statement required by this rule.

    In publishing this proposed rule, we are seeking comment on the specifics of the proposal. In particular, we seek comment on whether Wholesale Acquisition Cost is the amount that best reflects the “list price” for the stated purposes of price transparency and comparison shopping under this proposed regulation. We also seek comment on whether 30-day supply and typical course of treatment are appropriate metrics for a consumer to gauge the cost of the drug. We further seek comment on how to treat an advertised drug that must be used in combination with another non-advertised drug or device.

    We also seek comment as to whether the cost threshold of $35 to be exempt from compliance with this rule is the appropriate level and metric for such an exemption. This threshold was selected because it approximates the average copayment for a preferred brand drug. Given that the public is already accustomed to pay roughly this amount for drugs—and thus, in the absence of new information, may presume that patients will pay this amount for a drug—the public's interest in being informed of prices that are equal to or less than this amount is less strong than for prices in excess of this amount. We also considered incorporating a range for exempted drugs defined as less than $20 per month for a chronic condition or less than $50 for a course of treatment for an acute condition. In particular, we considered whether “chronic condition” and “acute condition” are sufficiently distinguishable to accomplish the stated regulatory purpose. These prices are also well below the lowest list price of advertised drugs. We seek comment on alternative approaches to determining a cost threshold, whether or not the threshold should be updated periodically, and if so, how the threshold should be updated.

    We also seek comment on the content of the proposed pricing information statement as described herein, including whether other specifications should be incorporated. For example, we seek comment as to whether a statement expressing an expiration date of the current price reflected in the advertisement should be incorporated into the required disclosure language so that consumers are informed that drug prices are subject to frequent changes and a drug price may differ from the date the advertisement is broadcast to the date that the drug is dispensed.

    We considered whether this regulation should apply to advertisements that are in other media forums such as radio, magazines, newspapers, internet websites and other forms of social media, but concluded that the purpose of this regulation is best served by limiting the requirements to only those identified herein. We seek comment as to whether we should apply this regulation to other media formats and, if so, what the presentation requirements should be.

    We further seek comment as to whether compliance with this rule should be a condition of payment, directly or indirectly, from these federal health programs.

    We are also considering additional solutions to provide beneficiaries with relevant information about the costs of prescription drugs and biological products so they can make informed decisions that minimize not only their out-of-pocket costs but also expenditures borne by Medicare and Medicaid. We seek comment on whether the following approaches could support price transparency and informed decision making, either in addition to or in lieu of the measures proposed in this notice of proposed rulemaking: (1) Kan enhanced CMS drug pricing dashboard, (2) a new payment code for drug pricing counseling, and (3) intelligent plan selection or use of intelligent assignment. We are also interested in other approaches to price transparency and informed decision making that we have not contemplated.

    CMS has released several information products that provide greater transparency on spending for drugs in the Medicare and Medicaid programs. The CMS Drug Spending Dashboards are interactive, web-based tools that provide spending information for drugs in the Medicare Part B and D programs as well as Medicaid. The Dashboards focus on average spending per dosage unit and change in average spending per dosage unit over time. The tools also include additional manufacturer-level drug spending information as well as consumer-friendly descriptions of the drug uses and clinical indications. We seek comment on whether manufacturers or others submitting additional information such as list price, typical out-of-pocket cost, therapeutic alternatives, pharmacoeconomic research, and other data could be helpful for consumers and what information would be most useful. We are also interested in feedback about the ease of which CMS dashboard data could be used by a non-government entity creating and maintaining such a price transparency resource for consumers and others. Additionally, CMS could announce updated information when a new DTC ad campaign is launched and public service announcements could be made to draw attention to the dashboard.

    In an effort to incentivize provider engagement with patients on their prescription drug out-of-pocket costs, CMS could create a new payment code, in a budget neutral manner, for doctors to dialogue with patients on the benefits of drugs and drug alternatives. This would likely decrease the number of prescriptions that go unfilled because of unexpected high out-of-pocket costs, thus improving adherence, but also could increase provider awareness of drug pricing which may influence prescribing when appropriate cheaper options are available.

    Through intelligent plan selection or use of intelligent assignment, beneficiaries could be provided with an auto-generated list of plans each year, based upon their most recent drug utilization, that would highlight opportunities for savings though competitor plans or alternative drugs (e.g., generics or biosimilars). This intelligent plan selection would help alleviate beneficiary anxiety associated with plan selection and encourage annual plan review by beneficiaries. Enrollment in suggested plans would be voluntary.

    III. Collection of Information Requirements

    Under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), we are required to provide 60-day notice in the Federal Register and solicit public comment before a collection of information requirement is submitted to the Office of Management and Budget (OMB) for review and approval. In order to fairly evaluate whether an information collection should be approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires that we solicit comment on the following issues:

    • The need for the information collection and its usefulness in carrying out the proper functions of our agency.

    • The accuracy of our estimate of the information collection burden.

    • The quality, utility, and clarity of the information to be collected.

    • Recommendations to minimize the information collection burden on the affected public, including automated collection techniques.

    In this proposed rule, we are soliciting public comment on the issues in this document that contain information collection requirements (ICRs). A. Wage Data

    To derive average costs, we used data from the U.S. Bureau of Labor Statistics' (BLS') May 2016 National Occupational Employment and Wage Estimates for all salary estimates (http://www.bls.gov/oes/current/oes_nat.htm). In this regard, the following table presents the mean hourly wage, the cost of fringe benefits and overhead (calculated at 100 percent of salary), and the adjusted hourly wage.

    Table F1—National Occupational Employment and Wage Estimates BLS occupation title Occupation code Mean hourly wage
  • ($/hr)
  • Adjusted
  • hourly wage
  • ($/hr)
  • Office and Administrative Support Occupations 43-0000 $18.24 $36.48 Marketing Managers 11-2021 63.57 127.14

    As indicated, we are adjusting our employee hourly wage estimates by a factor of 100 percent. This is necessarily a rough adjustment, both because fringe benefits and overhead costs vary significantly from employer to employer, and because methods of estimating these costs vary widely from study to study. Nonetheless, there is no practical alternative and we believe that doubling the hourly wage to estimate total cost is a reasonably accurate estimation method.

    B. ICRs Regarding Pricing Information (§ 403.1202)

    Proposed § 403.1202 would require that advertisements for certain prescription drug or biological products on television (including broadcast, cable, streaming, and satellite), contain a statement or statements indicating the Wholesale Acquisition Cost (referred to as the “list price”) for a typical 30-day regimen or for a typical course of treatment, whichever is most appropriate, as determined on the first day of the quarter during which the advertisement is being aired or otherwise broadcast. The presentation of this information must appear in a specific format. As stated earlier in Section II of this notice of proposed rulemaking, the notification must be presented as follows, “The list price for a [30-day supply of ] [typical course of treatment with] [name of prescription drug or biological product] is [insert list price]. If you have health insurance that covers drugs, your cost may be different.”

    We estimate that 25 pharmaceutical companies will run an estimated 300 distinct pharmaceutical ads that appear on television each quarter and will be affected by this rule. For these ads, we estimate that administrative support staff and marketing managers will need to verify the prescribed language and that the correct price appears in each advertisement each quarter. We estimate that this will require 10 minutes and $24.08 ($34.48/hr × .66) per advertisement for administrative support staff. We also estimate 5 minutes and $41.96 ($127.14/hr × .33) per advertisement for marketing managers, for a total of 15 minutes (0.25 hours) and $66.04 ($24.08 + $41.96) per advertisement per quarter or 300 hours per year across all pharmaceutical companies running affected televised advertisements ((300 ads/quarter) × (4 quarters/year) × (.25 hours/ad). As a result, using wage information provided in Table 1, we estimate costs of $19,812 (300 ads × $66.04/ad) per quarter or $79,248 in each year following publication of the final rule after adjusting for overhead and benefits.

    C. Submission of PRA-Related Comments

    We have submitted a copy of this proposed rule to OMB for its review of the rule's information collection and recordkeeping requirements. These requirements are not effective until they have been approved by the OMB.

    To obtain copies of the supporting statement and any related forms for the proposed collections discussed above, please visit CMS' website at website address at https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html or call the Reports Clearance Office at 410-786-1326.

    We invite public comments on these potential information collection requirements. If you wish to comment, please submit your comments electronically as specified in the ADDRESSES section of this proposed rule and identify the rule (CMS-4187-P) and where applicable the ICR's CFR citation, CMS ID number, and OMB control number.

    See the DATES and ADDRESSES sections of this proposed rule for further information.

    IV. Response to Comments

    Because of the large number of public comments we normally receive on Federal Register documents, we are not able to acknowledge or respond to them individually. We will consider all comments we receive by the date and time specified in the DATES section of this preamble, and, when we proceed with a subsequent document, we will respond to the comments in the preamble to that document.

    V. Regulatory Impact Analysis A. Statement of Need

    This proposed rule aims to improve the quality, accessibility and affordability of the Medicare Part C and Part D programs and to improve the CMS customer experience by providing transparency into drug prices with the goal of reducing the price to beneficiaries of certain prescription drugs and biological products. Currently, consumers have incomplete information regarding the cost of pharmaceutical products. As a result, they lack important information needed to inform their decisions, which likely leads to inefficient utilization of prescription drugs. This proposal will require disclosure of prescription drug prices to the general public for products advertised on television. This may improve awareness and allow the general public to respond, potentially increasing the efficiency of prescription drug utilization.

    B. Overall Impact

    We acknowledge that examination of the impact of this proposed rule is required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (January 18, 2011), the (RFA) (September 19, 1980, Pub. L. 96-354), Section 1102(b) of the Social Security Act, Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) (March 22, 1995; Pub. L., Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 1999), the Congressional Review Act (5 U.S.C. 804(2)), and Executive Order 13771 on Reducing Regulation and Controlling Regulatory Costs (January 30, 2017).

    The Regulatory Flexibility Analysis (RFA), as amended, requires agencies to analyze options for regulatory relief of small businesses, if a rule has a significant impact on a substantial number of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions.

    In addition, section 1102(b) of the Act requires us to prepare a regulatory analysis for any rule or regulation proposed under Title XVIII, Title XIX, or Part B of the Act that may have significant impact on the operations of a substantial number of small rural hospitals. We are not preparing an analysis for section 1102(b) of the Act because the Secretary certifies that this rule will not have a significant impact on the operations of a substantial number of small rural hospitals.

    Section 202 of UMRA also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending that may result in expenditures in any one year of $100 million in 1995 dollars, updated annually for inflation. In 2018, that threshold is approximately $150 million. This proposed rule is not anticipated to have an effect only on State, local, or tribal governments, in the aggregate, of $150 million or more, adjusted for inflation. We believe that the proposed rule would impose mandates on the private sector that would result in an expenditure of $150 million in at least one year.

    Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirements or costs on state and local governments, preempts state law, or otherwise has Federalism implications. Since reviewing this rule does not impose any substantial costs on state or local governments, under the requirements threshold criteria of Executive Order 13132 are not applicable, we have determined that this proposed rule would not significantly affect the rights, roles, and responsibilities of State or local governments.

    Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). The Office of Management and Budget has determined that this is an economically significant regulatory action. In accordance with the provisions of Executive Order 12866, this rule was reviewed by the Office of Management and Budget.

    Executive Order 13771 (January 30, 2017) requires that the costs associated with significant new regulations “to the extent permitted by law, be offset by the elimination of existing costs associated with at least two prior regulations.” The Department believes that this proposed rule is a significant regulatory action as defined by Executive Order 12866 which imposes costs, and therefore is considered a regulatory action under Executive Order 13771.

    C. Anticipated Effects

    This proposed rule would affect the operations of prescription drug manufacturers. According to the U.S. Census, there were 1,775 pharmaceutical and medicine manufacturing firms operating in the U.S. in 2015.16 We estimate that this rule will require individuals employed by these entities to spend time in order to comply with these regulations. We estimate the hourly wages of individuals affected by this proposed rule using the May 2016 National Occupational Employment and Wage Estimates provided by the U.S. Bureau of Labor Statistics. We assume that the total dollar value of labor, which includes wages, benefits, and overhead, is equal to 200 percent of the wage rate. We note that, throughout, estimates are presented in 2016 dollars. We use the wages of Lawyers as a proxy for legal staff, the wages of Marketing and Sales Managers as a proxy for marketing management staff, and Office and Administrative Support Occupations as a proxy for administrative support staff. Estimated hourly rates for all relevant categories are included below.

    16https://www.census.gov/data/tables/2015/econ/susb/2015-susb-annual.html.

    Table 1—Hourly Wages Marketing and Sales Managers $66.52 Lawyers 67.25 Office and Administrative Support Occupations 17.91

    In order to comply with the regulatory changes proposed in this proposed rule, affected businesses would first need to review the rule. We estimate that this would require an average of 2 hours for affected businesses to review, divided evenly between marketing managers and lawyers, in the first year following publication of the final rule. As a result, using wage information provided in Table 1, this implies costs of $0.47 million in the first year following publication of a final rule after adjusting for overhead and benefits.

    After reviewing the rule, prescription drug manufacturers will review their marketing strategies in the context of these new requirements, and determine how to respond. For some affected entities, this may mean substantially changing their advertising paradigm or pricing strategy. For others, much more modest changes are likely needed. We estimate that this would result in affected businesses spending an average of 20 hours reviewing their policies and determining how to respond, with 5 hours spent by lawyers and 15 hours spent by marketing managers, in the first year following publication of the final rule. In subsequent years, we estimate this would result in marketing managers at affected businesses spending an average of 10 hours implementing policy changes. As a result, using wage information provided in Table 1, we estimate costs of $4.74 million in the first year and $2.36 million in subsequent years following publication of the final rule after adjusting for overhead and benefits.

    We estimate that 25 pharmaceutical companies will run an estimated 300 distinct pharmaceutical ads that appear on television each quarter and will be affected by this rule. For these ads, we estimate that administrative support staff and marketing managers will need to verify the prescribed language and that the correct price appears in each advertisement each quarter. We estimate that this will require 10 minutes and $24.08 ($34.48/hr × .66) per advertisement for administrative support staff. We also estimate 5 minutes and $41.96 ($127.14/hr × .33) per advertisement for marketing managers, for a total of 15 minutes (0.25 hours) and $66.04 ($24.08 + $41.96) per advertisement per quarter or 300 hours per year across all pharmaceutical companies running affected televised advertisements ((300 ads/quarter) × (4 quarters/year) × (.25 hours/ad). As a result, using wage information provided in Table 1, we estimate costs of $19,812 (300 ads × $66.04/ad) per quarter or $79,248 in each year following publication of the final rule after adjusting for overhead and benefits.

    In markets for prescription drugs and biological products, consumers often need to make decisions with incomplete information about prices. As a result, consumers are unable to market decisions that best suit their needs. This rule may improve price transparency for consumers in order to ensure that their decisions better align with their preferences and their budget, potentially improving the allocation of resources in the prescription drug market. On the other hand, consumers, intimidated and confused by high list prices, may be deterred from contacting their physicians about drugs or medical conditions. Consumers might believe they are being asked to pay the list price rather than a co-pay or co-insurance and wonder why they are paying so much when they already paid a premium for their drug plan. This could discourage patients from using beneficial medications, reduce access, and potentially increase total cost of care. We lack data to quantify these effects, and seek public comment on these impacts, including comment on the best methods for extrapolating, to the prescription drug market, estimates of consumer response to the inclusion of prices in advertising that may have been developed in other contexts.

    In addition, we believe that this rule may provide a moderating force to counteract prescription drug increases. This rule will provide direct evidence of prescription drug prices to the general public, potentially improving awareness and allowing the general public to signal in some cases that prescription drug prices have risen beyond their willingness to pay. We believe that this, in turn, may further improve the rule's effect on the efficient utilization of prescription drugs. We lack data to quantify these effects, and seek public comment on these impacts.

    We believe that this rule may also have impacts along other dimensions. In particular, it may affect the number of televised DTC advertisements, the rate at which televised DTC advertisements are updated, prices for prescription drugs, the set of pharmaceutical products available for sale, and utilization of various prescription drugs. A possibility not reflected in the quantitative estimates above is that, with this proposed rule, drug companies would find the cost of revising their ads to be prohibitively expensive (for example, if they change their WACs so frequently that there is extensive monitoring and revision necessary to ensure that ads airing on a particular day match the WAC for that day). In this case, TV drug advertising would be reduced. However, we think this is unlikely as prices are usually changed on a twice-a-year cycle, and manufacturers may already frequently revise their ads to align with quarterly marketing plans. We therefore request comment on the following questions:

    • What is the frequency with which WACs are changed?

    • What would be the effect of this potential advertising reduction on patient behavior, including as regards the information they seek out from their medical providers?

    • How might patient outcomes vary depending on advertising choices among competitor drug companies? For example, if only some producers of drugs that treat a particular condition cease advertising on television, are patients likely to switch between drug brands—from the no-longer-advertised to the advertised? If all producers of drugs for a condition cease advertising on television, to what extent are patients likely to switch to other forms of treatment—such as surgery—or to forgo treatment?

    • To what extent will drug companies, in order to increase the feasibility of continuing to advertise on television, reduce the frequency of changing their WACs? What would be the consequences for drug supply chains and the prices experienced by patients and other payers?

    Furthermore, the Department recognizes that some studies indicate direct-to-consumer advertising increases disease awareness, and that if this rule decreases disease awareness such that untreated illness occurs, there may be other impacts. We lack data to quantify the effects of this rule along these dimensions, and we seek public comment on these impacts. In addition, we acknowledge that we may not have considered all areas in which the rule may have effects, and we seek public comment on impacts of the rule in areas we have not discussed here.

    As discussed above, the RFA requires agencies that issue a regulation to analyze options for regulatory relief of small entities if a proposed rule has a significant impact on a substantial number of small entities. HHS considers a rule to have a significant economic impact on a substantial number of small entities if at least 5 percent of small entities experience an impact of more than 3 percent of revenue. As discussed below, we calculate the costs of the proposed changes per affected business over 2020-2024. The estimated average costs of the rule per business peak in 2020 at approximately $2,900, and are approximately $1,300 in subsequent years. We note that relatively large entities are likely to experience proportionally higher costs. As discussed below, total costs of the rule are estimated to be $5.2 million in 2020 and $2.4 million in subsequent years. According to the U.S. Census, 1,775 pharmaceutical and medicine manufacturing firms operating in the U.S. in 2015 had annual payroll of $23.2 billion. Since the estimated costs of this proposed rule are a tiny fraction of payroll for covered entities, the Department anticipates that the proposed rule will not have a significant economic impact on a substantial number of small entities. We seek public comment on this determination, and the rule's impact on small entities.

    D. Alternatives Considered

    We carefully considered the alternative of maintaining the status quo and not pursuing regulatory action. However, we believe that the price transparency is fundamental to ensuring that prescription drug and biological product markets function properly. This rule may improve price transparency in order for consumers to make better decisions. As a result, we have determined that the benefits of the rule justify the costs imposed on industry, and as a result we chose to pursue this regulatory action.

    We also carefully considered requiring the disclosure of alternative or additional prices. If an alternative definition were used for list price, burden imposed by the rule would likely be higher. For example, manufacturers set the Wholesale Acquisition Cost, also known as list price, for their products. The Department recognizes that other prices may be paid by distributors, pharmacies, patients, and others in the supply chain. Because these other prices vary by contracts established by payors or others, only the Wholesale Acquisition Cost is certain to be known by the manufacturer when creating DTC ads. As such, it would be harder for manufacturers to report prices other than Wholesale Acquisition Cost. We believe that requiring the disclosure of WAC minimizes administrative burden among feasible alternatives and balances the need to provide information to the general public. We seek comments on these regulatory alternatives.

    E. Accounting Statement Table 2—Accounting Table of Benefits and Costs of All Proposed Changes Benefits: Present value over 2020-2024
  • by discount rate
  • (millions of 2016 dollars)
  • 3 Percent 7 Percent Annualized value over 2020-2024 by discount rate
  • (millions of 2016 dollars)
  • 3 Percent 7 Percent
    Quantified Benefits 0 0 0 0 Non-quantified Benefits: Improved transparency for prescription drug and biological product prices. Costs: 3 Percent 7 Percent 3 Percent 7 Percent Quantified Costs 12.1 9.4 2.6 2.3 Non-quantified Costs: See narrative discussion.
    List of Subjects in 42 CFR Part 403

    Grant programs—health, Health insurance, Hospitals, Intergovernmental relations, Medicare, Reporting and recordkeeping requirements.

    For the reasons set forth in the preamble, the Centers for Medicare & Medicaid Services proposes to amend 42 CFR chapter IV as set forth below:

    PART 403—SPECIAL PROGRAMS AND PROJECTS 1. The authority citation for part 403 is revised to read as follows: Authority:

    42 U.S.C. 1302, and 1395hh.

    2. Add subpart L to read as follows: Subpart L—Requirements for Direct to Consumer Television Advertisements of Drugs and Biological Products To Include the List Price of That Advertised Product Sec. 403.1200 Scope. 403.1201 Definitions. 403.1202 Pricing information. 403.1203 Specific presentation requirements. 403.1204 Compliance. Subpart L—Requirements for Direct to Consumer Television Advertisements of Drugs and Biological Products To Include the List Price of That Advertised Product
    § 403.1200 Scope.

    (a) Covered pharmaceuticals. Except as specified in paragraph (b) of this section, this subpart applies to advertisements for a prescription drug or biological product distributed in the United States for which payment is available, directly or indirectly, under titles XVIII or XIX of the Social Security Act.

    (b) Excepted pharmaceuticals. An advertisement for any prescription drug or biological product that has a list price, as defined in § 403.1201, less than $35 per month for a 30-day supply or typical course of treatment shall be exempt from the requirements of this subpart.

    § 403.1201 Definitions.

    (a) Biological product. Biological product means any biological product, as that term is defined in Public Health Service Act (“PHS Act”) section 351(i), that is licensed by the Food and Drug Administration pursuant to section 351 and is subject to the requirements of Federal Food, Drug, and Cosmetic Act (FDCA) section 503(b)(1).

    (b) Prescription drug. Prescription drug means any drug, as defined in the FDCA section 201(g), that has been approved by the Food and Drug Administration pursuant to FDCA section 505 and is subject to the requirements of FDCA section 503(b)(1).

    (c) List price. List price means the wholesale acquisition cost, as defined in paragraph (d) of this section.

    (d) Wholesale acquisition cost. Wholesale acquisition cost means, with respect to a drug or biological, the manufacturer's list price for the drug or biological to wholesalers or direct purchasers in the United States, not including prompt pay or other discounts, rebates or reductions in price, for the most recent month for which the information is available, as reported in wholesale price guides or other publications of drug or biological pricing data.

    § 403.1202 Pricing information.

    Any advertisement for any prescription drug or biological product on television (including broadcast, cable, streaming, or satellite) must contain a textual statement indicating the current list price for a typical 30-day regimen or for a typical course of treatment, whichever is most appropriate, as determined on the first day of quarter during which the advertisement is being aired or otherwise broadcast, as follows: “The list price for a [30-day supply of] [typical course of treatment with] [name of prescription drug or biological product] is [insert list price]. If you have health insurance that covers drugs, your cost may be different.” Where the price is related to the “typical course of treatment” and that course of treatment varies depending on the indication for which a drug is prescribed, the list price to be used is the one for the “course of treatment” associated with the primary indication addressed in the advertisement.

    § 403.1203 Specific presentation requirements.

    The textual statement described in § 403.1202 shall be presented at the end of an advertisement in a legible manner, meaning that it is placed appropriately and is presented against a contrasting background for sufficient duration and in a size and style of font that allows the information to be read easily.

    § 403.1204 Compliance.

    (a) Identification of non-compliant products. The Secretary shall maintain a public list that will include the drugs and biological products identified by the Secretary to be advertised in violation of this subpart.

    (b) State or local requirements. No State or political subdivision of any State may establish or continue in effect any requirement that depends in whole or in part on any pricing statement required by this subpart.

    Dated: October 11, 2018. Seema Verma, Administrator, Centers for Medicare & Medicaid Services. Dated: October 11, 2018. Alex M. Azar II, Secretary, Department of Health and Human Services.
    [FR Doc. 2018-22698 Filed 10-15-18; 4:15 pm] BILLING CODE 4120-01-P
    83 202 Thursday, October 18, 2018 Notices DEPARTMENT OF AGRICULTURE U.S. Codex Office U.S. Codex Program: FY2019-2023 Strategic Plan AGENCY:

    U.S. Codex Office, Department of Agriculture.

    ACTION:

    Notice of public meeting and request for comments.

    SUMMARY:

    The U.S Codex Office is finalizing the U.S. Codex Program's FY-2019-2023 Strategic Plan and is sponsoring a public meeting on November 2, 2018. The objective of the public meeting is to provide briefing information and receive public comments on the Plan's Goals and Objectives. The U.S Manager for Codex Alimentarius and the Under Secretary, Office of Trade and Foreign Agricultural Affairs recognize the importance of providing interested parties the opportunity to provide comments.

    DATES:

    The public meeting is scheduled for Friday, November 2, 2018, at 10:00 a.m. to 12:00 p.m.

    ADDRESSES:

    The public meeting will take place at the United States Department of Agriculture (USDA), Jamie L. Whitten Building, 1400 Independence Avenue SW, Room 107-A, Washington, DC 20250.

    Call-In-Number: If you wish to participate in the public meeting please use the call-in-number: 1-888-844-9904. The participant code will be posted on the following web page: http://www.usda.gov/codex.

    Registration and Comments: Attendees may register to attend the public meeting by emailing [email protected] by October 24th, 2018, and submit their comments electronically to that email address. Early registration is encouraged because it will expedite entry into the building. The meeting will take place in a Federal building. Attendees should bring photo identification and plan for adequate time to pass through the security screening systems. Attendees who are not able to attend the meeting in person, but who wish to participate, may do so by phone, as discussed above. For Further Information about the Public Meeting Contact: Sarah Lynch, U.S. Codex Office, 1400 Independence Avenue SW, Room 4861, South Agriculture Building, Washington, DC 20250. Phone: (202) 708-9515, Email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Background

    Codex was established in 1963 by two United Nations organizations, the Food and Agriculture Organization and the World Health Organization. Through adoption of food standards, codes of practice, and other guidelines developed by its committees, and by promoting their adoption and implementation by governments, Codex seeks to protect the health of consumers and ensure fair practices in the food trade.

    The U.S. Codex Program is a U.S. Government interagency partnership that engages stakeholders in advancing science-based international food standards to protect the health of consumers and ensure fair practices in the food trade. The U.S. Codex Office (USCO), housed in USDA's Trade and Foreign Agricultural Affairs mission area, acts as the national focal point for the U.S. Program. USCO manages the planning, support, policy development, and coordination of U.S. involvement in Codex, develops strategies to accomplish U.S. objectives, and serves as secretariat for U.S.-hosted committees.

    Public Meeting

    At the November 2, 2018, public meeting, U.S. Codex Program Goals and Objectives will be discussed, and attendees will have the opportunity to pose questions and offer comments. Written comments may be offered at the public meeting, or submitted after the meeting (by November 6, 2018) to [email protected] (see ADDRESSES). Written comments should state that they relate to the FY2019-2023 U.S. Codex Program Strategic Plan.

    Additional Public Notification

    Public awareness of all segments of rulemaking and policy development is important. Consequently, the U.S. Codex Office will announce this Federal Register publication on-line through the USDA web page located at: http://www.usda.gov/codex/, a link that also offers an email subscription service providing access to information related to Codex. Customers can add or delete their subscription themselves, and have the option to password protect their accounts.

    USDA Non-Discrimination Statement

    No agency, officer, or employee of the USDA shall, on the grounds of race, color, national origin, religion, sex, gender identity, sexual orientation, disability, age, marital status, family/parental status, income derived from a public assistance program, or political beliefs, exclude from participation in, deny the benefits of, or subject to discrimination any person in the United States under any program or activity conducted by the USDA.

    How To File a Complaint of Discrimination

    To file a complaint of discrimination, complete the USDA Program Discrimination Complaint Form, which may be accessed online at http://www.ocio.usda.gov/sites/default/files/docs/2012/Complain_combined_6_8_12.pdf, or write a letter signed by you or your authorized representative. Send your completed complaint form or letter to USDA by mail, fax, or email.

    Mail: U.S. Department of Agriculture, Director, Office of Adjudication, 1400 Independence Avenue SW, Washington, DC 20250-9410.

    Fax: (202) 690-7442, Email: [email protected]

    Persons with disabilities who require alternative means for communication (Braille, large print, audiotape, etc.) should contact USDA's TARGET Center at (202) 720-2600 (voice and TDD).

    Done at Washington DC on October 16, 2018. Mary Lowe, U.S. Manager for Codex Alimentarius.
    [FR Doc. 2018-22688 Filed 10-17-18; 8:45 am] BILLING CODE P
    ARCHITECTURAL AND TRANSPORTATION BARRIERS COMPLIANCE BOARD Meetings AGENCY:

    Architectural and Transportation Barriers Compliance Board

    ACTION:

    Notice of meetings.

    SUMMARY:

    The Architectural and Transportation Barriers Compliance Board (Access Board) plans to hold its regular committee and Board meetings in Washington, DC,

    Monday through Wednesday, November 5-7, 2018 at the times and location listed below.

    DATES:

    The schedule of events is as follows:

    Monday, November 5, 2018 10:00 a.m.-11:00 a.m. Planning and Evaluation Committee 11:00 a.m.-Noon Technical Programs Committee 1:30 p.m.-2:00 p.m. Ad Hoc Committee on Design Guidance 2:00 p.m.-4:00 p.m. Ad Hoc Committee on Frontier Issues Wednesday, November 7, 2018 9:30 a.m.-10:00 a.m. Budget Committee 10:00 a.m.-Noon Closed Session (training for Board members) 1:30 p.m.-3:00 p.m. Board Meeting ADDRESSES:

    Meetings will be held at the Access Board Conference Room, 1331 F Street NW, Suite 800, Washington, DC 20004.

    FOR FURTHER INFORMATION CONTACT:

    For further information regarding the meetings, please contact David Capozzi, Executive Director, (202) 272-0010 (voice); (202) 272-0054 (TTY).

    SUPPLEMENTARY INFORMATION:

    At the Board meeting scheduled on the afternoon of Wednesday, November 7, the Access Board will consider the following agenda items:

    • Approval of July 11, 2018 draft meeting minutes (vote) • Ad Hoc Committee Reports: Design Guidance; Frontier Issues • Planning and Evaluation Committee • Technical Programs Committee • Budget Committee • Election Assistance Commission Report • Executive Director's Report • Public Comment (final 15 minutes of the meeting)

    Members of the public can provide comments either in-person or over the telephone during the final 15 minutes of the Board meeting on Wednesday, November 7, 2018. Any individual interested in providing comment is asked to pre-register by sending an email to [email protected] with the subject line “Access Board meeting—Public Comment” with your name, organization, state, and topic of comment included in the body of your email. All emails to register for public comment must be received by Wednesday, October 31. Commenters will be provided with a call-in number and passcode before the meeting. Commenters will be called on in the order by which they are pre-registered. Due to time constraints, each commenter is limited to two minutes. Commenters on the telephone will be in a listen-only capacity until they are called on.

    All meetings are accessible to persons with disabilities. An assistive listening system, Communication Access Realtime Translation (CART), and sign language interpreters will be available at the Board meeting and committee meetings.

    Persons attending Board meetings are requested to refrain from using perfume, cologne, and other fragrances for the comfort of other participants (see www.access-board.gov/the-board/policies/fragrance-free-environment for more information).

    You may view the Wednesday, November 7, 2018 meeting through a live webcast from 1:30 p.m. to 3:00 p.m. at: www.access-board.gov/webcast.

    David M. Capozzi, Executive Director.
    [FR Doc. 2018-22689 Filed 10-17-18; 8:45 am] BILLING CODE 8150-01-P
    DEPARTMENT OF COMMERCE Economic Development Administration Notice of Petitions by Firms for Determination of Eligibility To Apply for Trade Adjustment Assistance AGENCY:

    Economic Development Administration, U.S. Department of Commerce.

    ACTION:

    Notice and opportunity for public comment.

    SUMMARY:

    The Economic Development Administration (EDA) has received petitions for certification of eligibility to apply for Trade Adjustment Assistance from the firms listed below. Accordingly, EDA has initiated investigations to determine whether increased imports into the United States of articles like or directly competitive with those produced by each of the firms contributed importantly to the total or partial separation of the firms' workers, or threat thereof, and to a decrease in sales or production of each petitioning firm.

    SUPPLEMENTARY INFORMATION:

    List of Petitions Received by EDA for Certification of Eligibility To Apply for Trade Adjustment Assistance [10/2/2018 through 10/11/2018] Firm name Firm address Date

  • accepted for
  • investigation
  • Product(s) Susan Jablon Mosaics, LLC 12 Alice Street, Binghamton, NY 13904 10/4/2018 The firm manufactures ceramic and glass tiles and mirrored glass. Daniels Business Services, Inc., d/b/a Daniels Graphics 131 Sweeten Creek Road, Asheville, NC 28803 10/9/2018 The firm manufactures packaging materials for the textile industry. Pure & Secure, LLC 4511 NW 42nd Street, Lincoln, NE 68524 10/10/2018 The firm manufactures water distillation products.

    Any party having a substantial interest in these proceedings may request a public hearing on the matter. A written request for a hearing must be submitted to the Trade Adjustment Assistance Division, Room 71030, Economic Development Administration, U.S. Department of Commerce, Washington, DC 20230, no later than ten (10) calendar days following publication of this notice. These petitions are received pursuant to section 251 of the Trade Act of 1974, as amended.

    Please follow the requirements set forth in EDA's regulations at 13 CFR 315.9 for procedures to request a public hearing. The Catalog of Federal Domestic Assistance official number and title for the program under which these petitions are submitted is 11.313, Trade Adjustment Assistance for Firms.

    Irette Patterson, Program Analyst.
    [FR Doc. 2018-22684 Filed 10-17-18; 8:45 am] BILLING CODE 3510-WH-P
    DEPARTMENT OF COMMERCE International Trade Administration Corporation for Travel Promotion Board of Directors AGENCY:

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

    ACTION:

    Second notice of an opportunity for travel and tourism industry leaders to apply for membership on the Board of Directors of the Corporation for Travel Promotion.

    SUMMARY:

    The Department of Commerce is again seeking applications from travel and tourism leaders from specific industries for membership on the Board of Directors (Board) of the Corporation for Travel Promotion (doing business as Brand USA). The purpose of the Board is to guide the Corporation for Travel Promotion on matters relating to the promotion of the United States as a travel destination and communication of travel facilitation issues, among other tasks. On July 19, 2018, the Department published in the Federal Register a “Notice of an opportunity for travel and tourism industry leaders to apply for membership on the Board of Directors of the Corporation for Travel Promotion” (83 FR 34112), announcing membership opportunities on the Board of Directors of the Corporation for Travel Promotion. The application period closed on August 17, 2018. The Department is now reopening the application period to solicit additional applications. This notice supplements the notice of July 19, 2018.

    Interested parties who have already applied in response to that Federal Register notice do not need to re-apply.

    DATES:

    All applications must be received by the National Travel and Tourism Office by close of business on Friday, October 26, 2018.

    ADDRESSES:

    Please submit application information by email to [email protected]

    FOR FURTHER INFORMATION CONTACT:

    Julie Heizer, National Travel and Tourism Office, U.S. Department of Commerce, 1401 Constitution Avenue NW, MS10003, Washington, DC 20230; telephone: 202-482-0140; email: [email protected]

    SUPPLEMENTARY INFORMATION:

    The Travel Promotion Act of 2009 (TPA) was signed into law on March 4, 2010 and was amended in July 2010 and December 2014. The TPA established the Corporation for Travel Promotion (the Corporation), as a non-profit corporation charged with the development and execution of a plan to (A) provide useful information to those interested in traveling to the United States; (B) identify and address perceptions regarding U.S. entry policies; (C) maximize economic and diplomatic benefits of travel to the United States through the use of various promotional tools; (D) ensure that international travel benefits all States and the District of Columbia, and (E) identify opportunities to promote tourism to rural and urban areas equally, including areas not traditionally visited by international travelers.

    The Corporation is governed by a Board of Directors, consisting of 11 members with knowledge of international travel promotion or marketing, broadly representing various regions of the United States. The TPA directs the Secretary of Commerce (after consultation with the Secretary of Homeland Security and the Secretary of State) to appoint the Board of Directors for the Corporation.

    On July 19, 2018, the Department published in the Federal Register a “Notice of an opportunity for travel and tourism industry leaders to apply for membership on the Board of Directors of the Corporation for Travel Promotion” (83 FR 34112), announcing membership opportunities on the Board of Directors of the Corporation for Travel Promotion. The application period closed on August 17, 2018. The Department is now reopening the application period to solicit additional applications. This notice supplements the notice of July 19, 2018. Interested parties who have already applied in response to that Federal Register notice do not need to re-apply.

    At this time, the Department will be selecting four individuals with the appropriate expertise and experience from specific sectors of the travel and tourism industry to serve on the Board as follows:

    (A) 1 shall have appropriate expertise and experience in the hotel accommodations sector;

    (B) 1 shall have appropriate expertise and experience as an official of a city convention and visitors' bureau;

    (C) 1 shall have appropriate expertise and experience in the restaurant sector; and

    (D) 1 shall have appropriate expertise and experience as an official of a state tourism office.

    To be eligible for Board membership, individuals must have international travel and tourism marketing experience, be a current or former chief executive officer, chief financial officer, or chief marketing officer or have held an equivalent management position. Additional consideration will be given to individuals who have experience working in U.S. multinational entities with marketing budgets, and/or who are audit committee financial experts as defined by the Securities and Exchange Commission (in accordance with 15 U.S.C. 7265). Individuals must be U.S. citizens, and in addition, cannot be federally registered lobbyists or registered as a foreign agent under the Foreign Agents Registration Act of 1938, as amended.

    Those selected for the Board must be able to meet the time and effort commitments of the Board.

    Board members serve at the discretion of the Secretary of Commerce (who may remove any member of the Board for good cause). The terms of office of each member of the Board appointed by the Secretary shall be three (3) years. Board members can serve a maximum of two consecutive full three-year terms. Board members are not considered Federal government employees by virtue of their service as a member of the Board and will receive no compensation from the Federal government for their participation in Board activities. Members participating in Board meetings and events may be paid actual travel expenses and per diem by the Corporation when away from their usual places of residence.

    Individuals who want to be considered for appointment to the Board should submit the following information by the Friday, October 26, 2018 deadline to the address listed in the ADDRESSES section above:

    1. Name, title, and personal resume of the individual requesting consideration, including address, email address and phone number.

    2. A brief statement of why the person should be considered for appointment to the Board. This statement should also address the individual's relevant international travel and tourism marketing experience and audit committee financial expertise, if any, and indicate clearly the sector or sectors enumerated above in which the individual has the requisite expertise and experience. Individuals who have the requisite expertise and experience in more than one sector can be appointed for only one of those sectors. Appointments of members to the Board will be made by the Secretary of Commerce.

    3. An affirmative statement that the applicant is a U.S. citizen and further, is not required to register as a foreign agent under the Foreign Agents Registration Act of 1938, as amended.

    Dated: October 12, 2018. Julie Heizer, Deputy Director, National Travel and Tourism Office.
    [FR Doc. 2018-22673 Filed 10-17-18; 8:45 am] BILLING CODE 3510-DR-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-580-868] Large Residential Washers From the Republic of Korea: Final Results of the First Five-Year Sunset Review of the Antidumping Duty Order AGENCY:

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

    SUMMARY:

    The Department of Commerce (Commerce) finds that revocation of the antidumping duty (AD) order on large residential washers from the Republic of Korea (Korea) would be likely to lead to continuation or recurrence of dumping at the levels indicated in the “Final Results of Sunset Review” section of this notice.

    DATES:

    Applicable October 18, 2018.

    FOR FURTHER INFORMATION CONTACT:

    David Goldberger, AD/CVD Operations, Office II, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: 202-482-4136.

    SUPPLEMENTARY INFORMATION:

    Background

    On April 26, 2018, Commerce published the Preliminary Results of the sunset review,1 finding that dumping was likely to continue or recur if the Order2 were revoked and determined that revocation of the Order would be likely to lead to continuation or recurrence of dumping at the magnitude of weighted-average margins up to 82.41 percent.3 We invited interested parties to comment on the Preliminary Results. We received a case brief from LG Electronics Inc. (LGEKR), LG Electronics U.S.A., Inc. (LGEUS), and LG Electronics Alabama, Inc. (LGEAI) (collectively LGE), representing the respondent interested parties on May 29, 2018, and a rebuttal brief from the domestic interested party, Whirlpool Corporation (Whirlpool), on June 4, 2018.

    1See Large Residential Washers from the Republic of Korea: Preliminary Results of the First Five-Year Sunset Review of the Antidumping Duty Order, 83 FR 18275 (April 26, 2018) (Preliminary Results) and accompanying Preliminary Decision Memorandum.

    2See Large Residential Washers from Mexico and the Republic of Korea: Antidumping Duty Orders, 78 FR 11148 (February 15, 2013) (Order).

    3See Preliminary Results, 83 FR at 18276.

    Scope of the Order

    The products covered by the Order are all large residential washers and certain subassemblies thereof from Korea. The products are currently classifiable under subheadings 8450.20.0040 and 8450.20.0080 of the Harmonized Tariff Schedule of the United States (HTSUS). Products subject to this order may also enter under HTSUS subheadings 8450.11.0040, 8450.11.0080, 8450.90.2000, and 8450.90.6000. Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of the merchandise subject to this scope is dispositive.4

    4 For a complete description of the Scope of the Order, see Memorandum, “Issues and Decision Memorandum for the Final Results of First Sunset Review of the Antidumping Duty Order on Large Residential Washers from the Republic of Korea,” dated concurrently with this notice (Issues and Decision Memorandum).

    Analysis of Comments Received

    All issues raised for the final results of this sunset review are addressed in the Issues and Decision Memorandum, dated concurrently with this final notice, which is hereby adopted by this notice. The issues discussed in the Issues and Decision Memorandum include the likelihood of the continuation or recurrence of dumping and the magnitude of the margins of dumping likely to prevail. A list of the issues addressed in the Issues and Decision Memorandum is included in the Appendix to this notice. The Issues and Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at http://access.trade.gov and in the Central Records Unit, room B8024 of the main Department of Commerce building. In addition, a complete version of the Issues and Decision Memorandum can be accessed directly on the internet at http://enforcement.trade.gov/frn/. The signed and electronic versions of the Issues and Decision Memorandum are identical in content.

    Final Results of Sunset Review

    We determine that revocation of the AD Order on large residential washers from Korea would be likely to lead to a continuation or recurrence of dumping at weighted-average margins up to 82.41 percent.

    Notification to Interested Parties

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

    We are issuing and publishing the final results of this full sunset review, in accordance with sections 751(c)(5)(A), 752(c), and 777(i) of the Tariff Act of 1930, as amended, and 19 CFR 351.218(f)(3).

    Dated: September 4, 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. Appendix List of Topics Discussed in the Issues and Decision Memorandum 1. Summary 2. Background 3. Scope of the Order 4. Discussion of the Issues Comment 1: Whether Commerce's Preliminary Conclusion that Revocation of the Antidumping Order Would be Likely to Lead to Continuation or Recurrence of Dumping is Contradicted by the Evidentiary Record and Contrary to Law Comment 2: Whether Commerce's Preliminary Conclusion that, Upon Revocation, LGE Would Engage in Dumping of 82.41 Percent is Contrary to Law and Contradicted by the Evidentiary Record 5. Recommendation
    [FR Doc. 2018-22635 Filed 10-17-18; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-351-842] Certain Uncoated Paper From Brazil: Final Results of Antidumping Duty Administrative Review; 2015-2017 AGENCY:

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

    SUMMARY:

    The Department of Commerce (Commerce) determines that certain uncoated paper (uncoated paper) from Brazil is being sold at less than normal value during the period of review (POR), August 27, 2015, through February 28, 2017.

    DATES:

    Applicable October 18, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Jerry Huang, AD/CVD Operations, Office V, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-4047.

    SUPPLEMENTARY INFORMATION:

    Background

    On April 10, 2018, Commerce published the preliminary results of the antidumping duty administrative review on uncoated paper from Brazil.1 The review covers one producer/exporter of the subject merchandise, Suzano Papel e Celulose S.A. (Suzano). For a discussion of events since the Preliminary Results were published, see the accompanying Issues and Decision Memorandum.2

    1See Certain Uncoated Paper from Brazil: Preliminary Results of Antidumping Duty Administrative Review; 2015-2017, 83 FR 15368 (April 10, 2018) (Preliminary Results).

    2See Memorandum, “Certain Uncoated Paper from Brazil: Issues and Decision Memorandum for the Final Results of the Antidumping Duty Administrative Review; 2015-2017,” dated concurrently with, and hereby adopted by, this notice (Issues and Decision Memorandum).

    Scope of the Order

    The product covered by this review is uncoated paper from Brazil. For a full description of the scope, see the Issues and Decision Memorandum dated concurrently with and hereby adopted by this notice.

    Analysis of Comments Received

    All issues raised in the case and rebuttal briefs by parties to this administrative review are addressed in the Issues and Decision Memorandum.3 A list of the issues that parties raised and to which we responded is attached to this notice as an Appendix. The Issues and Decision Memorandum is a public document and is on-file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at https://access.trade.gov and in the Central Records Unit (CRU), room B8024 of the main Commerce building. In addition, a complete version of the Issues and Decision Memorandum can be accessed directly on the internet at http://enforcement.trade.gov/frn/index.html. The signed Issues and Decision Memorandum and the electronic versions of the Issues and Decision Memorandum are identical in content.

    3Id.

    Changes Since the Preliminary Results

    Based on a review of the record and comments received from interested parties, we have recalculated Suzano's weighted-average dumping margin and, based on our findings at verification, we have made certain changes to Suzano's margin calculation. For further discussion, see the Issues and Decision Memorandum.

    Final Results of the Administrative Review

    We determine that the following weighted-average dumping margin exists for the period August 27, 2015 through February 28, 2017.

    Exporter/producer Weighted-
  • average
  • margin
  • (percent)
  • Suzano Papel e Celulose S.A 18.80
    Assessment Rate

    Commerce shall determine, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries covered by this review. For entries of subject merchandise during the period of review produced by Suzano for which they did not know their merchandise was destined for the United States, we will instruct CBP to liquidate unreviewed entries at the all-others rate if there is no rate for the intermediate company(ies) involved in the transaction. We intend to issue liquidation instructions to CBP 15 days after publication of the final results of this review.

    Cash Deposit Requirements

    The following cash deposit requirements will be effective upon publication of the notice of final results of this review for all shipments of uncoated paper from Brazil entered, or withdrawn from warehouse, for consumption on or after the date of publication as provided by section 751(a)(2) of the Act: (1) The cash deposit rate for companies subject to this review will be equal to the weighted-average dumping margins established in the final results of the review; (2) for merchandise exported by companies not covered in this review but covered in a prior segment of this proceeding, the cash deposit rate will continue to be the company-specific rate published for the most recent period; (3) if the exporter is not a firm covered in this review or the original investigation but the producer is, the cash deposit rate will be the rate established for the most recently completed segment for the producer of the merchandise; (4) the cash deposit rate for all other producers or exporters will continue to be 27.11 percent, the all-others rate established in the less-than-fair-value investigation.4 These cash deposit requirements, when imposed, shall remain in effect until further notice.

    4See Certain Uncoated Paper from Australia, Brazil, Indonesia, the People's Republic of China, and Portugal: Amended Final Affirmative Antidumping Determinations for Brazil and Indonesia and Antidumping Duty Orders, 81 FR 11173 (March 3, 2016).

    Notification to Importers

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

    Administrative Protective Order

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

    Commerce is issuing and publishing these results in accordance with sections 751(a)(1) and 777(i) of the Act and 19 CFR 351.221(b)(5).

    Dated: October 9, 2018. Gary Taverman, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, performing the non-exclusive functions and duties for the Assistant Secretary for Enforcement and Compliance. Appendix List of Topics Discussed in the Final Decision Memorandum I. Summary II. Background III. Scope of the Order IV. List of Comments V. Discussion of Comments Comment 1: Treatment of Suzano's Sales to an U.S. Foreign Trade Zone (FTZ) Comment 2: Treatment of Suzano's Credit Expenses Comment 3: Treatment of INSS Taxes Comment 4: Suzano's Liquidation Instructions Comment 5: Programming Issue in Suzano's Margin Calculation VI. Recommendation
    [FR Doc. 2018-22720 Filed 10-17-18; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [C-570-096] Aluminum Wire and Cable From the People's Republic of China: Initiation of Countervailing Duty Investigation AGENCY:

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

    DATES:

    Applicable October 11, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Nancy Decker at (202) 482-0196 or Mark Hoadley at (202) 482-3148, AD/CVD Operations, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230.

    SUPPLEMENTARY INFORMATION:

    The Petition

    On September 21, 2018, the U.S. Department of Commerce (Commerce) received a countervailing duty (CVD) Petition concerning imports of aluminum wire and cable from the People's Republic of China (China), filed in proper form on behalf of Encore Wire Corporation and Southwire Company, LLC (the petitioners), which are domestic producers of aluminum wire and cable.1 The CVD Petition was accompanied by an antidumping duty (AD) Petition concerning imports of aluminum wire and cable from China.

    1See letter from the petitioners, “Aluminum Wire and Cable from China: Antidumping and Countervailing Duty Petitions,” dated September 21, 2018 (the Petition).

    On September 25 and 26, 2018, Commerce requested supplemental information pertaining to certain aspects of the Petition in two separate supplemental questionnaires, one dealing with general issues with the Petition and the other with issues related to Volume III of the Petition (i.e., the CVD allegation).2 The petitioners filed their combined response to the supplemental questionnaires on September 28, 2018.3

    2See letters from Commerce, “Petition for the Imposition of Countervailing Duties on Imports of Aluminum Wire and Cable from the People's Republic of China: Supplemental Questions” (CVD Deficiency Questionnaire), dated September 25, 2018, and “Petitions for the Imposition of Antidumping and Countervailing Duties on Imports of Aluminum Wire and Cable from the People's Republic of China: Supplemental Questions” (General Issues Deficiency Questionnaire), dated September 26, 2018.

    3See letter from the petitioners, “Aluminum Wire and Cable from China: Amendment of Petitions and Response to Commerce's Supplemental Questions” dated September 28, 2018 (Petition Supplement).

    In accordance with section 702(b)(1) of the Tariff Act of 1930, as amended (the Act), the petitioners allege that the Government of China (GOC) is providing countervailable subsidies, within the meaning of sections 701 and 771(5) of the Act, to producers of aluminum wire and cable in China and that imports of such products are materially injuring, or threatening material injury to, the domestic industry producing aluminum wire and cable in the United States. Consistent with section 702(b)(1) of the Act and 19 CFR 351.202(b), for those alleged programs on which we are initiating a CVD investigation, the Petition is accompanied by information reasonably available to the petitioners supporting their allegations.

    Commerce finds that the petitioners filed the Petition on behalf of the domestic industry because the petitioners are an interested party as defined in section 771(9)(C) of the Act. Commerce also finds that the petitioners demonstrated sufficient industry support necessary for the initiation of the requested CVD investigation.4

    4See “Determination of Industry Support for the Petition” section, infra.

    Period of Investigation

    Because the Petition was filed on September 28, 2018, the period of investigation is January 1, 2017, through December 31, 2017.

    Scope of the Investigation

    The product covered by this investigation is aluminum wire and cable from China. For a full description of the scope of this investigation, see the Appendix to this notice.

    Scope Comments

    During our review of the Petition, Commerce contacted the petitioners regarding the proposed scope language to ensure that the scope language in the Petition is an accurate reflection of the products for which the domestic industry is seeking relief.5 As a result of the petitioners' submission, the scope of the Petition was modified to clarify the description of merchandise covered by the Petition. The description of the merchandise covered by this initiation, as described in the Appendix to this notice, reflects these clarifications.

    5See Supplemental Questionnaire Response at 7-8 and Exhibit I (Revised Scope).

    As discussed in the Preamble to Commerce's regulations, we are setting aside a period for interested parties to raise issues regarding product coverage (scope).6 Commerce will consider all comments received from interested parties and, if necessary, will consult with interested parties prior to the issuance of the preliminary determination. If scope comments include factual information,7 all such factual information should be limited to public information. To facilitate preparation of its questionnaires, Commerce requests that all interested parties submit such comments by 5:00 p.m. Eastern Time (ET) on October 31, 2018, which is 20 calendar days from the signature date of this notice. Any rebuttal comments, which may include factual information, must be filed by 5:00 p.m. ET on November 13, 2018.8

    6See Antidumping Duties; Countervailing Duties, Final Rule, 62 FR 27296, 27323 (May 19, 1997) (Preamble).

    7See 19 CFR 351.102(b)(21) (defining “factual information”).

    8See 19 CFR 351.303(b). Rebuttal comments are normally due 10 days after the comment deadline. In this case, 10 calendar days from the initial comments deadline falls on Saturday, November 10, 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).

    Commerce requests that any factual information parties consider relevant to the scope of the investigation be submitted during this period. However, if a party subsequently finds that additional factual information pertaining to the scope of the investigation may be relevant, the party may contact Commerce and request permission to submit the additional information. All such submissions must be filed on the records of the concurrent AD and CVD investigations.

    Filing Requirements

    All submissions to Commerce must be filed electronically using Enforcement and Compliance's Antidumping Duty and Countervailing Duty Centralized Electronic Service System (ACCESS).9 An electronically filed document must be received successfully in its entirety by the time and date it is due. Documents exempted from the electronic submission requirements must be filed manually (i.e., in paper form) with Enforcement and Compliance's APO/Dockets Unit, Room 18022, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230, and stamped with the date and time of receipt by the applicable deadlines.

    9See Antidumping and Countervailing Duty Proceedings: Electronic Filing Procedures; Administrative Protective Order Procedures, 76 FR 39263 (July 6, 2011). See also Enforcement and Compliance: Change of Electronic Filing System Name, 79 FR 69046 (November 20, 2014) for details of Commerce's electronic filing requirements, which went into effect on August 5, 2011. Information on help using ACCESS can be found at https://access.trade.gov/help.aspx, and a handbook can be found at https://access.trade.gov/help/Handbook%20on%20Electronic%20Filling%20Procedures.pdf.

    Consultations

    Pursuant to sections 702(b)(4)(A)(i) and (ii) of the Act, Commerce notified representatives of the GOC of the receipt of the Petition and provided them the opportunity for consultations with respect to the CVD Petition.10 The GOC did not request consultations.

    10See Commerce letter, “Countervailing Duty Petition on Aluminum Wire and Cable from the People's Republic of China: Invitation for Consultations to Discuss the Countervailing Duty Petition,” dated September 24, 2018.

    Determination of Industry Support for the Petition

    Section 702(b)(1) of the Act requires that a petition be filed on behalf of the domestic industry. Section 702(c)(4)(A) of the Act provides that a petition meets this requirement if the domestic producers or workers who support the petition account for: (i) At least 25 percent of the total production of the domestic like product; and (ii) more than 50 percent of the production of the domestic like product produced by that portion of the industry expressing support for, or opposition to, the petition. Moreover, section 702(c)(4)(D) of the Act provides that, if the petition does not establish support of domestic producers or workers accounting for more than 50 percent of the total production of the domestic like product, Commerce shall: (i) Poll the industry or rely on other information in order to determine if there is support for the petition, as required by subparagraph (A); or (ii) determine industry support using a statistically valid sampling method to poll the “industry.”

    Section 771(4)(A) of the Act defines the “industry” as the producers as a whole of a domestic like product. Thus, to determine whether a petition has the requisite industry support, the statute directs Commerce to look to producers and workers who produce the domestic like product. The International Trade Commission (ITC), which is responsible for determining whether “the domestic industry” has been injured, must also determine what constitutes a domestic like product in order to define the industry. While both Commerce and the ITC must apply the same statutory definition regarding the domestic like product,11 they do so for different purposes and pursuant to a separate and distinct authority. In addition, Commerce's determination is subject to limitations of time and information. Although this may result in different definitions of the like product, such differences do not render the decision of either agency contrary to law.12

    11See section 771(10) of the Act.

    12See USEC, Inc. v. United States, 132 F. Supp. 2d 1, 8 (CIT 2001) (citing Algoma Steel Corp., Ltd. v. United States, 688 F. Supp. 639, 644 (CIT 1988), aff'd 865 F.2d 240 (Fed. Cir. 1989)).

    Section 771(10) of the Act defines the domestic like product as “a product which is like, or in the absence of like, most similar in characteristics and uses with, the article subject to an investigation under this title.” Thus, the reference point from which the domestic like product analysis begins is “the article subject to an investigation” (i.e., the class or kind of merchandise to be investigated, which normally will be the scope as defined in the petition).

    With regard to the domestic like product, the petitioners do not offer a definition of the domestic like product distinct from the scope of the investigation.13 Based on our analysis of the information submitted on the record, we have determined that aluminum wire and cable, as defined in the scope, constitutes a single domestic like product, and we have analyzed industry support in terms of that domestic like product.14

    13See Volume I of the Petition, at 87-89.

    14 For a discussion of the domestic like product analysis as applied to this case and information regarding industry support, see Countervailing Duty Investigation Initiation Checklist: Aluminum Wire and Cable from the People's Republic of China (China CVD Initiation Checklist), at Attachment II, Analysis of Industry Support for the Antidumping and Countervailing Duty Petitions Covering Aluminum Wire and Cable from the People's Republic of China (Attachment II). This checklist is dated concurrently with, and hereby adopted by, this notice and on file electronically via ACCESS. Access to documents filed via ACCESS is also available in the Central Records Unit, Room B8024 of the main Department of Commerce building.

    In determining whether the petitioners have standing under section 702(c)(4)(A) of the Act, we considered the industry support data contained in the Petition with reference to the domestic like product as defined in the “Scope of the Investigation,” in the Appendix to this notice. To establish industry support, the petitioners provided their own shipment values of the domestic like product in 2017 and compared this to the estimated total shipment value of the domestic like product for the entire industry.15 Because total 2017 production volume data for the domestic like product for the entire domestic industry are not reasonably available to the petitioners, and the petitioners have established that shipment values are a reasonable proxy for production data,16 we have relied on the data the petitioners provided for purposes of measuring industry support.17

    15See Volume I of the Petition, at 5-6 and Exhibits GEN-02 through GEN-04; see also Petition Supplement, at 8-11 and Exhibit K.

    16Id.

    17Id. For further discussion, see China CVD Initiation Checklist, at Attachment II.

    Our review of the data provided in the Petition, the Petition Supplement, and other information readily available to Commerce indicates that the petitioners have established industry support for the Petition.18 First, the Petition established support from domestic producers (or workers) accounting for more than 50 percent of the total production of the domestic like product and, as such, Commerce is not required to take further action in order to evaluate industry support (e.g., polling).19 Second, the domestic producers (or workers) have met the statutory criteria for industry support under section 702(c)(4)(A)(i) of the Act because the domestic producers (or workers) who support the Petition account for at least 25 percent of the total production of the domestic like product.20 Finally, the domestic producers (or workers) have met the statutory criteria for industry support under section 702(c)(4)(A)(ii) of the Act because the domestic producers (or workers) who support the Petition account for more than 50 percent of the production of the domestic like product produced by that portion of the industry expressing support for, or opposition to, the Petition.21 Accordingly, Commerce determines that the Petition was filed on behalf of the domestic industry within the meaning of section 702(b)(1) of the Act.

    18See China CVD Initiation Checklist, at Attachment II.

    19Id.; see also section 702(c)(4)(D) of the Act.

    20See China CVD Initiation Checklist, at Attachment II.

    21Id.

    Commerce finds that the petitioners filed the Petition on behalf of the domestic industry because they are interested parties as defined in section 771(9)(C) of the Act, and they have demonstrated sufficient industry support with respect to the CVD investigation that they are requesting that Commerce initiate.22

    22Id.

    Injury Test

    Because China is a “Subsidies Agreement Country” within the meaning of section 701(b) of the Act, section 701(a)(2) of the Act applies to this investigation. Accordingly, the ITC must determine whether imports of the subject merchandise from China materially injure, or threaten material injury to, a U.S. industry.

    Allegations and Evidence of Material Injury and Causation

    The petitioners allege that imports of the subject merchandise are benefitting from countervailable subsidies and that such imports are causing, or threaten to cause, material injury to the U.S. industry producing the domestic like product. In addition, the petitioners allege that subject imports exceed the negligibility threshold provided for under section 771(24)(A) of the Act.23

    23See Volume I of the Petition, at 90-91 and Exhibit GEN-19.

    The petitioner contends that the industry's injured condition is illustrated by a significant and increasing volume of subject imports; underselling and price depression or suppression; depressed absolute level of capacity utilization; decline in the domestic industry's financial performance; and lost sales and revenues.24 We have assessed the allegations and supporting evidence regarding material injury, threat of material injury, and causation, and we have determined that these allegations are properly supported by adequate evidence, and meet the statutory requirements for initiation.25

    24Id., at 85-86, 90-101 and Exhibits GEN-16, GEN-19 and GEN-26 through GEN-29; see also Petition Supplement, at 11-14 and Exhibit L.

    25See China CVD Initiation Checklist, at Attachment III, Analysis of Allegations and Evidence of Material Injury and Causation for the Antidumping and Countervailing Duty Petitions Covering Aluminum Wire and Cable from the People's Republic of China (Attachment III).

    Initiation of CVD Investigation

    Based on the examination of the Petition, we find that the Petition meets the requirements of section 702 of the Act. Therefore, we are initiating a CVD investigation to determine whether imports of aluminum wire and cable from China benefit from countervailable subsidies conferred by the GOC. In accordance with section 703(b)(1) of the Act and 19 CFR 351.205(b)(1), unless postponed, we will make our preliminary determination no later than 65 days after the date of this initiation.

    Based on our review of the Petition, we find that there is sufficient information to initiate a CVD investigation on all of the subsidy programs alleged in the Petition, with certain limitations. For a full discussion of the basis for our decision to initiate on each program, see China CVD Initiation Checklist. A public version of the initiation checklist for this investigation is available on ACCESS.

    Respondent Selection

    The petitioners named 27 producers/exporters as accounting for the majority of exports of aluminum wire and cable to the United States from China.26 In the event Commerce determines that the number of companies is large and it cannot individually examine each company based upon Commerce's resources, where appropriate, Commerce intends to select mandatory respondents based on U.S. Customs and Border Protection (CBP) data for U.S. imports of aluminum wire and cable from China during the POI under the appropriate Harmonized Tariff Schedule of the United States numbers listed in the “Scope of the Investigation,” in the Appendix. On October 9, 2018, we released CBP data under Administrative Protective Order (APO) to all parties with access to information protected by APO and indicated that interested parties wishing to comment regarding the CBP data and respondent selection must do so within three business days of the publication date of the notice of initiation of this CVD investigation.27 Commerce will not accept rebuttal comments regarding the CBP data or respondent selection.

    26See Volume I of the Petition at 13-18.

    27See memorandum, “Aluminum Wire and Cable from the People's Republic of China; Release of Customs Data from U.S. Customs and Border Protection,” dated October 9, 2018.

    Interested parties must submit applications for disclosure under APO in accordance with 19 CFR 351.305(b). Instructions for filing such applications may be found on the Commerce's website at http://enforcement.trade.gov/apo.

    Comments regarding respondent selection must be filed electronically using ACCESS. An electronically filed document must be received successfully, in its entirety, by ACCESS no later than 5:00 p.m. ET on the date established by Commerce. We intend to finalize our decisions regarding respondent selection within 20 days of publication of this notice.

    Distribution of Copies of the Petition

    In accordance with section 702(b)(4)(A)(i) of the Act and 19 CFR 351.202(f), copies of the public versions of the Petition have been provided to the GOC via ACCESS. To the extent practicable, we will attempt to provide a copy of the public version of the Petition to each exporter named in the Petition, as provided under 19 CFR 351.203(c)(2).

    ITC Notification

    We will notify the ITC of our initiation, as required by section 702(d) of the Act.

    Preliminary Determination by the ITC

    The ITC will preliminarily determine, within 45 days after the date on which the Petition was filed, whether there is a reasonable indication that imports of aluminum wire and cable from China are materially injuring, or threatening material injury to, a U.S. industry.28 A negative ITC determination will result in the investigation being terminated.29 Otherwise, this investigation will proceed according to statutory and regulatory time limits.

    28See section 703(a)(2) of the Act.

    29See section 703(a)(1) of the Act.

    Submission of Factual Information

    Factual information is defined in 19 CFR 351.102(b)(21) as: (i) Evidence submitted in response to questionnaires; (ii) evidence submitted in support of allegations; (iii) publicly available information to value factors under 19 CFR 351.408(c) or to measure the adequacy of remuneration under 19 CFR 351.511(a)(2); (iv) evidence placed on the record by Commerce; and (v) evidence other than factual information described in (i)-(iv). 19 CFR 351.301(b) requires any party, when submitting factual information, to specify under which subsection of 19 CFR 351.102(b)(21) the information is being submitted 30 and, if the information is submitted to rebut, clarify, or correct factual information already on the record, to provide an explanation identifying the information already on the record that the factual information seeks to rebut, clarify, or correct.31 Time limits for the submission of factual information are addressed in 19 CFR 351.301, which provides specific time limits based on the type of factual information being submitted. Interested parties should review the regulations prior to submitting factual information in this investigation.

    30See 19 CFR 351.301(b).

    31See 19 CFR 351.301(b)(2).

    Extensions of Time Limits

    Parties may request an extension of time limits before the expiration of a time limit established under 19 CFR 351.301, or as otherwise specified by the Secretary. In general, an extension request will be considered untimely if it is filed after the expiration of the time limit established under 19 CFR 351.301. For submissions that are due from multiple parties simultaneously, an extension request will be considered untimely if it is filed after 10:00 a.m. ET on the due date. Under certain circumstances, we may elect to specify a different time limit by which extension requests will be considered untimely for submissions which are due from multiple parties simultaneously. In such a case, we will inform parties in the letter or memorandum of the deadline (including a specified time) by which extension requests must be filed to be considered timely. An extension request must be made in a separate, stand-alone submission; under limited circumstances we will grant untimely-filed requests for the extension of time limits. Parties should review Extension of Time Limits; Final Rule, 78 FR 57790 (September 20, 2013), available at http://www.thefederalregister.org/fdsys/pkg/FR-2013-09-20/html/2013-22853.htm, prior to submitting factual information in this investigation.

    Certification Requirements

    Any party submitting factual information in an AD or CVD proceeding must certify to the accuracy and completeness of that information.32 Parties must use the certification formats provided in 19 CFR 351.303(g).33 Commerce intends to reject factual submissions if the submitting party does not comply with the applicable certification requirements.

    32See section 782(b) of the Act.

    33See Certification of Factual Information to Import Administration During Antidumping and Countervailing Duty Proceedings, 78 FR 42678 (July 17, 2013) (“Final Rule”); see also frequently asked questions regarding the Final Rule, available at http://enforcement.trade.gov/tlei/notices/factual_info_final_rule_FAQ_07172013.pdf.

    Notification to Interested Parties

    Interested parties must submit applications for disclosure under APO in accordance with 19 CFR 351.305. On January 22, 2008, Commerce published Antidumping and Countervailing Duty Proceedings: Documents Submission Procedures; APO Procedures, 73 FR 3634 (January 22, 2008). Parties wishing to participate in this investigation should ensure that they meet the requirements of these procedures (e.g., the filing of letters of appearance as discussed at 19 CFR 351.103(d)).

    This notice is issued and published pursuant to sections 702 and 777(i) of the Act and 19 CFR 351.203(c).

    Dated: October 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. Appendix I Scope of the Investigation

    The scope of the investigation covers aluminum wire and cable, which is defined as an assembly of one or more electrical conductors made from 8000 Series Aluminum Alloys (defined in accordance with ASTM B800), Aluminum Alloy 1350 (defined in accordance with ASTM B230/B230M or B609/B609M), and/or Aluminum Alloy 6201 (defined in accordance with ASTM B398/B398M), provided that: (1) At least one of the electrical conductors is insulated; (2) each insulated electrical conductor has a voltage rating greater than 80 volts and not exceeding 1000 volts; and (3) at least one electrical conductor is stranded and has a size not less than 16.5 thousand circular mil (kcmil) and not greater than 1000 kcmil. The assembly may: (1) Include a grounding or neutral conductor; (2) be clad with aluminum, steel, or other base metal; or (3) include a steel support center wire, one or more connectors, a tape shield, a jacket or other covering, and/or filler materials.

    Most aluminum wire and cable products conform to National Electrical Code (NEC) types THHN, THWN, THWN-2, XHHW-2, USE, USE-2, RHH, RHW, or RHW-2, and also conform to Underwriters Laboratories (UL) standards UL-44, UL-83, UL-758, UL-854, UL-1063, UL-1277, UL-1569, UL-1581, or UL-4703, but such conformity is not required for the merchandise to be included within the scope.

    The scope of the investigation specifically excludes conductors that are included in equipment already assembled at the time of importation. Also excluded are aluminum wire and cable products in actual lengths less than six feet.

    The merchandise covered by the investigation is currently classifiable under subheading 8544.49.9000 of the Harmonized Tariff Schedule of the United States (HTSUS). Products subject to the scope may also enter under HTSUS subheading 8544.42.9090. The HTSUS subheadings are provided for convenience and customs purposes. The written description of the scope of the investigation is dispositive.

    [FR Doc. 2018-22655 Filed 10-17-18; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration Quarterly Update to Annual Listing of Foreign Government Subsidies on Articles of Cheese Subject to an In-Quota Rate of Duty AGENCY:

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

    DATES:

    Applicable October 18, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Stephanie Moore, AD/CVD Operations, Office III, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Ave. NW, Washington, DC 20230, telephone: (202) 482-3692.

    SUPPLEMENTARY INFORMATION:

    On August 8, 2018, the Department of Commerce (Commerce), pursuant to section 702(h) of the Trade Agreements Act of 1979 (as amended) (the Act), published the quarterly update to the annual listing of foreign government subsidies on articles of cheese subject to an in-quota rate of duty covering the period January 1, 2018, through March 31, 2018.1 In the First Quarter 2018 Update, we requested that any party that has information on foreign government subsidy programs that benefit articles of cheese subject to an in-quote rate of duty submit such information to Commerce.2 We received no comments, information or requests for consultation from any party.

    1See Quarterly Update to Annual Listing of Foreign Government Subsidies on Articles of Cheese Subject to an In-Quota Rate of Duty, 83 FR 39061 (August 8, 2018) (First Quarter 2018 Update).

    2Id.

    Pursuant to section 702(h) of the Act, we hereby provide Commerce's update of subsidies on articles of cheese that were imported during the period April 1, 2018, through June 30, 2018. The appendix to this notice lists the country, the subsidy program or programs, and the gross and net amounts of each subsidy for which information is currently available.

    Commerce will incorporate additional programs which are found to constitute subsidies, and additional information on the subsidy programs listed, as the information is developed. Commerce encourages any person having information on foreign government subsidy programs which benefit articles of cheese subject to an in-quota rate of duty to submit such information in writing to the Assistant Secretary for Enforcement and Compliance, U.S. Department of Commerce, 1401 Constitution Ave. NW, Washington, DC 20230.

    This determination and notice are in accordance with section 702(a) of the Act.

    Dated: October 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. Appendix Subsidy Programs on Cheese Subject to an In-Quota Rate of Duty Country Program(s) Gross 3
  • subsidy
  • ($/lb)
  • Net 4
  • subsidy
  • ($/lb)
  • 28 European Union Member States 5 European Union Restitution Payments 0.00 0.00 Canada Export Assistance on Certain Types of Cheese 0.45 0.45 Norway Indirect (Milk) Subsidy
  • Consumer Subsidy
  • 0.00
  • 0.00
  • 0.00
  • 0.00
  • Total 0.00 0.00 Switzerland Deficiency Payments 0.00 0.00

    3 Defined in 19 U.S.C. 1677(5).

    4 Defined in 19 U.S.C. 1677(6).

    5 The 28 member states of the European Union are: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, and the United Kingdom.

    [FR Doc. 2018-22613 Filed 10-17-18; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-570-983] Drawn Stainless Steel Sinks From the People's Republic of China: Partial Rescission of Antidumping Duty Administrative Review; 2017—2018 AGENCY:

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

    SUMMARY:

    The Department of Commerce (Commerce) is partially rescinding its administrative review of the antidumping duty (AD) order on drawn stainless steel sinks (drawn sinks) from the People's Republic of China (China) for the period of review (POR) April 1, 2017, through March 31, 2018.

    DATES:

    Applicable October 18, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Joshua Tucker, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-2044.

    SUPPLEMENTARY INFORMATION:

    Background

    On April 2, 2018, Commerce published in the Federal Register a notice of “Opportunity to Request Administrative Review” of the AD order on drawn sinks from China for the POR.1

    1See Antidumping or Countervailing Duty Order, Finding, or Suspended Investigation; Opportunity to Request Administrative Review, 83 FR 13949 (April 2, 2018).

    In April 2018, Commerce received multiple timely requests to conduct an administrative review of the AD order on drawn sinks from China.

    On June 6, 2018, in accordance with section 751(a) of the Tariff Act of 1930, as amended (the Act), Commerce published in the Federal Register a notice of initiation of an administrative review of the AD order.2 The administrative review was initiated with respect to 31 companies, and covers the period April 1, 2017, through March 31, 2018. Subsequent to the initiation of the administrative review, the petitioner in this proceeding, Elkay Manufacturing Company, timely withdrew its review requests for 18 of these companies, as discussed below.

    2See Initiation of Antidumping and Countervailing Duty Administrative Reviews, 83 FR 26258 (June 6, 2018) (Initiation Notice).

    Partial Rescission of Review

    Pursuant to 19 CFR 351.213(d)(1), Commerce will rescind an administrative review, in whole or in part, if a party that requested a review withdraws its request within 90 days of the date of publication of the notice of initiation of the requested review. The petitioner withdrew its request for an administrative review of the following companies within 90 days of the date of publication of the Initiation Notice:3 Foshan Shunde MingHao Kitchen Utensils Co., Ltd.; Foshan Zhaoshun Trade Co., Ltd.; Franke Asia Sourcing Ltd.; Grand Hill Work Company; Guandong Dongyuan Kitchenware Industrial Co., Ltd.; Guandong Yingao Kitchen Utensils Co., Ltd.; Hangzhou Heng's Industries Co., Ltd.; Hubei Foshan Success Imp & Exp Co. Ltd.; J&C Industries Enterprise Limited; Jiangmen Hongmao Trading Co., Ltd.; Jiangxi Zoje Kitchen & Bath Industry Co., Ltd.; Ningbo Oulin Kitchen Utensils Co., Ltd.; Primy Cooperation Limited; Shenzhen Kehuaxing Industrial Ltd.; Shunde Foodstuffs Import & Export Company Limited of Guangdong; Shunde Native Produce Import and Export Co., Ltd. of Guangdong; Zhongshan Newecan Enterprise Development Corporation; and Zhongshan Silk Imp. & Exp. Group Co., Ltd. of Guangdong. Accordingly, Commerce is rescinding this review, in part, with respect to these companies, in accordance with 19 CFR 353.213(d)(1).4

    3See Letter from the Petitioner, “Re: Drawn Stainless Steel Sinks from the People's Republic of China: Notice of Partial Withdrawal of Request for Administrative Review,” dated August 2, 2018.

    4 Commerce no longer considers the non-market economy entity as an exporter conditionally subject to administrative reviews. See Antidumping Proceedings; Announcement of Change in Department Practice for Respondent Selection in Antidumping Duty Proceedings and Conditional Review of the Nonmarket Economy Entity in NME Antidumping Duty Proceedings, 78 FR 65963 (November 3, 2013).

    The instant review will continue with respect to the following companies: B&R Industries Limited; Elkay (China) Kitchen Solutions, Co., Ltd.; Feidong Import and Export Co., Ltd.; Guangdong G-Top Import and Export Co., Ltd.; Guangdong New Shichu Import & Export Company Limited; Jiangmen New Star Hi-Tech Enterprise Ltd.; Jiangmen Pioneer Import & Export Co., Ltd.; KaiPing Dawn Plumbing Products, Inc.; Ningbo Afa Kitchen and Bath Co., Ltd.; Xinhe Stainless Steel Products Co., Ltd.; Yuyao Afa Kitchenware Co., Ltd; Zhongshan Superte Kitchenware Co., Ltd.; and Zhuhai Kohler Kitchen & Bathroom Products Co., Ltd.

    Assessment

    Commerce will instruct U.S. Customs and Border Protection (CBP) to assess antidumping duties on all appropriate entries. For the companies for which this review is rescinded, antidumping duties shall be assessed at rates equal to the cash deposit of estimated antidumping duties required at the time of entry, or withdrawal from warehouse, for consumption, in accordance with 19 CFR 351.212(c)(1)(i). Commerce intends to issue appropriate assessment instructions directly to CBP 15 days after the date of publication of this notice in the Federal Register.

    Notification to Importers

    This notice serves as the only reminder to importers whose entries will be liquidated as a result of this rescission notice, of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties and/or countervailing duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement may result in the presumption that reimbursement of antidumping duties and/or countervailing duties occurred and the subsequent assessment of double antidumping duties.

    Notification Regarding Administrative Protective Order

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

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

    Dated: October 12, 2018. James Maeder, Associate Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations performing the duties of Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations.
    [FR Doc. 2018-22719 Filed 10-17-18; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-471-807] Certain Uncoated Paper From Portugal: Final Results of Antidumping Duty Administrative Review; 2015-2017 AGENCY:

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

    SUMMARY:

    The Department of Commerce (Commerce) is amending its final results of the administrative review of the antidumping duty (AD) order on certain uncoated paper from Portugal to correct a ministerial error.

    DATES:

    Applicable October 18, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Carrie Bethea, AD/CVD Operations, Office V, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-1491.

    SUPPLEMENTARY INFORMATION: Background

    On August 13, 2018, the Department of Commerce (Commerce) published its Final Results of the first administrative review of the antidumping duty order on certain uncoated paper from Portugal.1 Also on August 13, 2018, The Navigator Company, S.A. (Navigator), the respondent in this administrative review, submitted comments alleging ministerial errors in Commerce's Final Results.2 On August 22, 2018, United Steel, Paper and Forestry, Rubber, Manufacturing, Energy, Allied Industrial Service Workers International Union, AFL-CIO, CLC (USW); and the Packaging Corporation of America (PCA) (collectively, the petitioners), submitted a reply rebutting Navigator's ministerial error allegation.3 Following the comment period, Navigator contested Commerce's Final Results before the Court of International Trade. As such, Commerce obtained leave of court to consider Navigator's ministerial allegations.

    1See Certain Uncoated Paper from Portugal: Final Results of Antidumping Duty Administrative Review; 2015-2017, 83 FR 39982 (August 13, 2018) (Final Results), and accompanying Issues and Decision Memorandum (IDM).

    2See Navigator's Letter, “Ministerial Error Allegation,” dated August 13, 2018 (Navigator Ministerial Error Allegation).

    3See Petitioners' Letter, “Petitioners' Response to Navigator's Ministerial Error Allegation,” dated August 22, 2018 (Petitioners' Ministerial Error Response).

    Amendment to Final Results

    Commerce reviewed the record and agrees in part with Navigator that it committed a ministerial error in our application of AFA.4 In our Final Results, Commerce commited an inadvertent error within the meaning of section 735(e) of the Tariff Act of 1930 (the Act) and 19 CFR 351.224(f).5 Therfore, pursuant to 19 CFR 351.224(e), Commerce is amending the Final Results to reflect the correction of this ministerial error in the calculation of the final margin assigned to Navigator, which changes from 37.34 percent to 1.75 percent.6

    4See Memorandum, “Ministerial Error Memorandum for the Amended Final Results of the First Administrative Review,” signed concurrently with this notice.

    5Id.

    6See Memorandum, “Amended Final Determination Calculations for the Navigator Company, S.A.,” dated October XX, 2018.

    Commerce also agrees with Navigator that we incorrectly published the period of review (POR) in the “Final Results of Review” section in the Final Results, which should have been stated as the period of August 26, 2015, through February 28, 2017. These amended final results of the review reflect the correct POR throughout.

    Amended Final Results of the Review

    We determine that, for the period of August 26, 2015, through February 28, 2017, the following weighted-average dumping margin exists:

    Exporter/producer Weighted-
  • average
  • dumping
  • margin
  • (percent)
  • The Navigator Company, S.A 1.75
    Disclosure

    We intend to disclose the calculation performed for these amended final results in accordance with 19 CFR 351.224(b).

    Duty Assessment

    Commerce shall determine, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries covered by this review.

    In accordance with Commerce's “automatic assessment” practice, for entries of subject merchandise during the POR produced by Navigator for which it did not know that the merchandise was destined for the United States, we will instruct CBP to liquidate those entries at the all-others rate if there is no rate for the intermediate company(ies) involved in the transaction.

    We intend to issue instructions to CBP 15 days after the publication date of the final results of this review.

    Cash Deposit Requirements

    The following cash deposit requirements will be effective upon publication of the notice of final results of administrative review for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date of the final results of this administrative review, as provided by section 751(a)(2)(C) of the Act: (1) The cash deposit rate for Navigator will be the rate established in the final results of this administrative review; (2) for merchandise exported by producers or exporters not covered in this administrative review but covered in a prior segment of the proceeding, the cash deposit rate will continue to be the company-specific rate published for the most recently completed segment of this proceeding; (3) if the exporter is not a firm covered in this review, a prior review, or the original investigation, but the producer is, the cash deposit rate will be the rate established for the most recently completed segment of this proceeding for the producer of the subject merchandise; and (4) the cash deposit rate for all other manufacturers or exporters will continue to be 7.80 percent, the all-others rate established in the investigation.7 These cash deposit requirements, when imposed, shall remain in effect until further notice.

    7See Certain Uncoated Paper from Portugal: Final Determination of Sales at Less than Fair Value and Final Negative Determination of Critical Circumstances, 81 FR 3105 (January 20, 2016).

    Notification to Importers

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

    Administrative Protective Order

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

    We are issuing and publishing this notice in accordance with section 735(e) of the Act and 19 CFR 351.224(e) and (f).

    Dated: October 9, 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. 2018-22575 Filed 10-17-18; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-570-095] Aluminum Wire and Cable From the People's Republic of China: Initiation of Less-Than-Fair-Value Investigation AGENCY:

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

    DATES:

    Applicable October 11, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Kathryn Turlo at (202) 482-3870 or Mark Hoadley at (202) 482-3148; AD/CVD Operations, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC, 20230.

    SUPPLEMENTARY INFORMATION:

    The Petition

    On September 21, 2018, the U.S. Department of Commerce (Commerce) received an antidumping duty (AD) petition concerning imports of aluminum wire and cable from the People's Republic of China (China), filed in proper form on behalf of Encore Wire Corporation (Encore) and Southwire Company, LLC (the petitioners), domestic producers of aluminum wire and cable.1 The AD Petition was accompanied by a countervailing duty (CVD) Petition concerning imports of aluminum wire and cable from China.

    1See letter from the petitioners, “Aluminum Wire and Cable from China: Antidumping and Countervailing Duty Petitions,” dated September 21, 2018 (the Petition).

    On September 25 and 26, 2018, Commerce requested supplemental information pertaining to certain aspects of the Petition in two separate supplemental questionnaires, one dealing with general issues with the Petition and the other with issues related to Volume I and Volume II of the Petition (i.e., the AD allegation).2 The petitioners filed their combined response to the supplemental questionnaires on September 28, 2018.3

    2See letters from Commerce, “Petition for the Imposition of Antidumping Duties on Imports of Aluminum Wire and Cable from the People's Republic of China: Supplemental Questions,” dated September 25, 2018 (AD Supplemental Questionnaire), and “Petitions for the Imposition of Antidumping and Countervailing Duties on Imports of Aluminum Wire and Cable from the People's Republic of China: Supplemental Questions,” dated September 26, 2018 (General Issues Supplemental Questionnaire).

    3See letter from the petitioners, “Aluminum Wire and Cable from China: Amendment of Petitions and Response to Commerce's Supplemental Questions” dated September 28, 2018 (Petition Supplement).

    In accordance with section 732(b) of the Tariff Act of 1930, as amended (the Act), the petitioners allege that imports of aluminum wire and cable from China are being, or are likely to be, sold in the United States at less-than-fair-value (LTFV) within the meaning of section 731 of the Act, and that such imports are materially injuring, or threatening material injury to, the domestic industry producing aluminum wire and cable in the United States. Consistent with section 732(b)(1) of the Act, the Petition is accompanied by information reasonably available to the petitioners supporting their allegation.

    Commerce finds that the petitioners filed the Petition on behalf of the domestic industry because the petitioners are interested parties as defined in section 771(9)(C) of the Act. Commerce also finds that the petitioners demonstrated sufficient industry support with respect to the initiation of the requested AD investigation.4

    4See the “Determination of Industry Support for the Petition” section, infra.

    Period of Investigation

    Because China is a non-market economy (NME) country, pursuant to 19 CFR 351.204(b)(1), the period of investigation (POI) is January 1, 2018, through June 30, 2018.

    Scope of the Investigation

    The product covered by this investigation is aluminum wire and cable from China. For a full description of the scope of this investigation, see the Appendix to this notice.

    Scope Comments

    During our review of the Petition, Commerce contacted the petitioners regarding the proposed scope language to ensure that the scope language in the Petition is an accurate reflection of the products for which the domestic industry is seeking relief.5 As a result of the petitioners' submission, the scope of the Petition was modified to clarify the description of merchandise covered by the Petition. The description of the merchandise covered by this initiation, as described in the Appendix to this notice, reflects these clarifications.

    5See Petition Supplement, at 7-8 and Exhibit I (Revised Scope).

    As discussed in the Preamble to Commerce's regulations, we are setting aside a period for interested parties to raise issues regarding product coverage (scope).6 Commerce will consider all comments received from interested parties and, if necessary, will consult with interested parties prior to the issuance of the preliminary determination. If scope comments include factual information,7 all such factual information should be limited to public information. To facilitate preparation of its questionnaires, Commerce requests that all interested parties submit scope comments by 5:00 p.m. Eastern Time (ET) on October 31, 2018, which is 20 calendar days from the signature date of this notice. Any rebuttal comments, which may include factual information, must be filed by 5:00 p.m. ET on November 13, 2018.8

    6See Antidumping Duties; Countervailing Duties, Final Rule, 62 FR 27296, 27323 (May 19, 1997).

    7See 19 CFR 351.102(b)(21) (defining “factual information”).

    8See 19 CFR 351.303(b). Rebuttal comments are normally due 10 days after the comment deadline. In this case, 10 calendar days from the initial comments deadline falls on Saturday, November 10, 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).

    Commerce requests that any factual information parties consider relevant to the scope of the investigation be submitted during this period. However, if a party subsequently finds that additional factual information pertaining to the scope of the investigation may be relevant, the party may contact Commerce and request permission to submit the additional information. All such submissions must be filed on the records of the concurrent AD and CVD investigations.

    Filing Requirements

    All submissions to Commerce must be filed electronically using Enforcement and Compliance's Antidumping Duty and Countervailing Duty Centralized Electronic Service System (ACCESS).9 An electronically filed document must be received successfully in its entirety by the time and date it is due. Documents exempted from the electronic submission requirements must be filed manually (i.e., in paper form) with Enforcement and Compliance's APO/Dockets Unit, Room 18022, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230, and stamped with the date and time of receipt by the applicable deadlines.

    9See Antidumping and Countervailing Duty Proceedings: Electronic Filing Procedures; Administrative Protective Order Procedures, 76 FR 39263 (July 6, 2011); see also Enforcement and Compliance; Change of Electronic Filing System Name, 79 FR 69046 (November 20, 2014) for details of Commerce's electronic filing requirements, effective August 5, 2011. Information on help using ACCESS can be found at https://access.trade.gov/help.aspx and a handbook can be found at https://access.trade.gov/help/Handbook%20on%20Electronic%20Filling%20Procedures.pdf.

    Comments on Product Characteristics for AD Questionnaire

    Commerce is providing interested parties an opportunity to comment on the appropriate physical characteristics of aluminum wire and cable to be reported in response to Commerce's AD questionnaire. This information will be used to identify the key physical characteristics of the merchandise under consideration in order to report the relevant factors of production accurately, as well as to develop appropriate product-comparison criteria.

    Interested parties may provide any information or comments that they feel are relevant to the development of an accurate list of physical characteristics. In order to consider the suggestions of interested parties in developing and issuing the AD questionnaire, all product characteristics comments must be filed by 5:00 p.m. ET on October 31, 2018, which is 20 calendar days from the signature date of this notice.10 Any rebuttal comments must be filed by 5:00 p.m. ET on November 12, 2018. All comments and submissions to Commerce must be filed electronically using ACCESS, as explained above, on the record of the China LTFV investigation.

    10See 19 CFR 351.303(b).

    Determination of Industry Support for the Petition

    Section 732(b)(1) of the Act requires that a petition be filed on behalf of the domestic industry. Section 732(c)(4)(A) of the Act provides that a petition meets this requirement if the domestic producers or workers who support the petition account for: (i) At least 25 percent of the total production of the domestic like product; and (ii) more than 50 percent of the production of the domestic like product produced by that portion of the industry expressing support for, or opposition to, the petition. Moreover, section 732(c)(4)(D) of the Act provides that, if the petition does not establish support of domestic producers or workers accounting for more than 50 percent of the total production of the domestic like product, Commerce shall: (i) Poll the industry or rely on other information in order to determine if there is support for the petition, as required by subparagraph (A); or (ii) determine industry support using a statistically valid sampling method to poll the “industry.”

    Section 771(4)(A) of the Act defines the “industry” as the producers as a whole of a domestic like product. Thus, to determine whether a petition has the requisite industry support, the statute directs Commerce to look to producers and workers who produce the domestic like product. The International Trade Commission (ITC), which is responsible for determining whether “the domestic industry” has been injured, must also determine what constitutes a domestic like product in order to define the industry. While both Commerce and the ITC must apply the same statutory definition regarding the domestic like product,11 they do so for different purposes and pursuant to a separate and distinct authority. In addition, Commerce's determination is subject to limitations of time and information. Although this may result in different definitions of the like product, such differences do not render the decision of either agency contrary to law.12

    11See section 771(10) of the Act.

    12See USEC, Inc. v. United States, 132 F. Supp. 2d 1, 8 (CIT 2001) (citing Algoma Steel Corp., Ltd. v. United States, 688 F. Supp. 639, 644 (CIT 1988), aff'd 865 F.2d 240 (Fed. Cir. 1989)).

    Section 771(10) of the Act defines the domestic like product as “a product which is like, or in the absence of like, most similar in characteristics and uses with, the article subject to an investigation under this title.” Thus, the reference point from which the domestic like product analysis begins is “the article subject to an investigation” (i.e., the class or kind of merchandise to be investigated, which normally will be the scope as defined in the Petition).

    With regard to the domestic like product, the petitioners do not offer a definition of the domestic like product distinct from the scope of the Petition.13 Based on our analysis of the information submitted on the record, we have determined that aluminum wire and cable, as defined in the scope, constitutes a single domestic like product, and we have analyzed industry support in terms of that domestic like product.14

    13See Volume I of the Petition, at 87-89.

    14 For a discussion of the domestic like product analysis as applied to this case and information regarding industry support, see Antidumping Duty Investigation Initiation Checklist: Aluminum Wire and Cable from the People's Republic of China (China AD Initiation Checklist), at Attachment II, Analysis of Industry Support for the Antidumping and Countervailing Duty Petitions Covering Aluminum Wire and Cable from the People's Republic of China (Attachment II). This checklist is dated concurrently with, and hereby adopted by, this notice and on file electronically via ACCESS. Access to documents filed via ACCESS is also available in the Central Records Unit, Room B8024 of the main Department of Commerce building.

    In determining whether the petitioners have standing under section 732(c)(4)(A) of the Act, we considered the industry support data contained in the Petition with reference to the domestic like product as defined in the “Scope of the Investigation,” in the Appendix to this notice. To establish industry support, the petitioners provided their own shipment values of the domestic like product in 2017, and compared this to the estimated total shipment value of the domestic like product for the entire domestic industry.15 Because total 2017 production volume data for the domestic like product for the entire domestic industry are not reasonably available to the petitioners, and the petitioners have established that shipment values are a reasonable proxy for production data,16 we have relied on the data the petitioners provided for purposes of measuring industry support.17

    15See Volume I of the Petition, at 5-6 and Exhibits GEN-02 through GEN-04; see also Petition Supplement, at 8-11 and Exhibit K.

    16Id.

    17Id. For further discussion, see China AD Initiation Checklist, at Attachment II.

    Our review of the data provided in the Petition, the Petition Supplement, and other information readily available to Commerce indicates that the petitioners have established industry support for the Petition.18 First, the Petition established support from domestic producers (or workers) accounting for more than 50 percent of the total production of the domestic like product and, as such, Commerce is not required to take further action in order to evaluate industry support (e.g., polling).19 Second, the domestic producers (or workers) have met the statutory criteria for industry support under section 732(c)(4)(A)(i) of the Act because the domestic producers (or workers) who support the Petition account for at least 25 percent of the total production of the domestic like product.20 Finally, the domestic producers (or workers) have met the statutory criteria for industry support under section 732(c)(4)(A)(ii) of the Act because the domestic producers (or workers) who support the Petition account for more than 50 percent of the production of the domestic like product produced by that portion of the industry expressing support for, or opposition to, the Petition.21 Accordingly, Commerce determines that the Petition was filed on behalf of the domestic industry within the meaning of section 732(b)(1) of the Act.

    18See China AD Initiation Checklist, at Attachment II.

    19See section 732(c)(4)(D) of the Act; see also China AD Initiation Checklist, at Attachment II.

    20See China AD Initiation Checklist, at Attachment II.

    21Id.

    Commerce finds that the petitioners filed the Petition on behalf of the domestic industry because they are interested parties as defined in section 771(9)(C) of the Act, and they have demonstrated sufficient industry support with respect to the AD investigation that they are requesting that Commerce initiate.22

    22Id.

    Allegations and Evidence of Material Injury and Causation

    The petitioners allege that the U.S. industry producing the domestic like product is being materially injured, or is threatened with material injury, by reason of the imports of the subject merchandise sold at less than normal value (NV). In addition, the petitioners allege that subject imports exceed the negligibility threshold provided for under section 771(24)(A) of the Act.23

    23See Volume I of the Petition, at 90-91 and Exhibit GEN-19.

    The petitioners contend that the industry's injured condition is illustrated by a significant and increasing volume of subject imports; underselling and price depression or suppression; depressed absolute level of capacity utilization; decline in the domestic industry's financial performance; and lost sales and revenues.24 We have assessed the allegations and supporting evidence regarding material injury, threat of material injury, and causation, and we have determined that these allegations are properly supported by adequate evidence, and meet the statutory requirements for initiation.25

    24Id. at 85-86, 90-101 and Exhibits GEN-16, GEN-19 and GEN-26 through GEN-29; see also Petition Supplement, at 11-14 and Exhibit L.

    25See China AD Initiation Checklist, at Attachment III, Analysis of Allegations and Evidence of Material Injury and Causation for the Antidumping and Countervailing Duty Petitions Covering Aluminum Wire and Cable from the People's Republic of China (Attachment III).

    Allegations of Sales at LTFV

    The following is a description of the allegations of sales at LTFV upon which Commerce based its decision to initiate an AD investigation of imports of aluminum wire and cable from China. The sources of data for the deductions and adjustments relating to U.S. price and NV are discussed in greater detail in the China AD Initiation Checklist.

    Export Price

    The petitioners based U.S. export price (EP) on price sheets for aluminum wire and cable offered for sale in the United States. The price sheet was from a U.S. distributor of aluminum wire and cable in the United States who is the leading U.S. distributor of aluminum wire and cable produced by a Chinese producer/exporter of subject merchandise.26 The petitioners made deductions from the U.S. prices for estimated distributor's markup and international freight and customs duties.27

    26See Volume I of the Petition, at 20-23 and Exhibit GEN-13; see also Petition Supplement, at Exhibit D.

    27Id.

    Normal Value

    Commerce considers China to be an NME country.28 In accordance with section 771(18)(C)(i) of the Act, any determination that a foreign country is an NME country shall remain in effect until revoked by Commerce. Therefore, we continue to treat China as an NME country for purposes of the initiation of this investigation. Accordingly, NV in China is appropriately based on factors of production (FOPs) valued in a surrogate market economy country, in accordance with section 773(c) of the Act.29

    28See Antidumping Duty Investigation of Certain Aluminum Foil from the People's Republic of China: Affirmative Preliminary Determination of Sales at Less-Than-Fair Value and Postponement of Final Determination, 82 FR 50858, 50861 (November 2, 2017) (citing Memorandum to Gary Taverman, “China's Status as a Non-Market Economy,” dated October 26, 2017), unchanged in Certain Aluminum Foil from the People's Republic of China: Final Determination of Sales at Less Than Fair Value, 83 FR 9282 (March 5, 2018).

    29See China AD Initiation Checklist, at 8-9.

    The petitioners claim that Mexico is an appropriate surrogate country for China because (1) Mexico is a market economy and at a comparable level of economic development as China, based on per capita gross national income,30 (2) Mexico is a significant producer of comparable merchandise,31 and (3) public information from Mexico is available to value all material input factors.32 The petitioners provided publicly available information from Mexico to value all FOPs.33 Therefore, based on the information provided by the petitioners, we determine that it is appropriate to use Mexico as the primary surrogate country for initiation purposes.34

    30See Volume II of the Petition, at Exhibit GEN-17.

    31See Volume II of the Petition, at Exhibits GEN-18 and GEN-19.

    32See Volume I of the Petition, at 24.

    33See Volume II of the Petition, at GEN-21 and GEN-22.

    34See China AD Initiation Checklist, at 8.

    Interested parties will have the opportunity to submit comments regarding surrogate country selection and, pursuant to 19 CFR 351.301(c)(3)(i), will be provided an opportunity to submit publicly available information to value FOPs within 30 days before the scheduled date of the preliminary determination.

    Factors of Production

    Based on their assertion that the specifications for aluminum wire and cable products are standard across all producers in the United States and China, the petitioners used Encore's own consumption rates to estimate FOPs of Chinese producers/exporters.35 In addition, the petitioners valued the estimated FOPs using surrogate values from Mexico in U.S. dollars.36

    35See Volume I of the Petition, at 24; see also Volume II of the Petition, at Exhibits GEN-16 and GEN-20.

    36See Volume I of the Petition, at 24-25; see also Volume II of the Petition, at Exhibits GEN-20, GEN-21 and GEN-22.

    Fair Value Comparisons

    Based on the data provided by the petitioners, there is reason to believe that imports of aluminum wire and cable from China are being, or are likely to be, sold in the United States at LTFV. Based on comparisons of EP to NV in accordance with sections 772 and 773 of the Act, the estimated dumping margins for aluminum wire and cable from China are 53.54—63.47 percent.37

    37See Petition Supplement, at 7 and Exhibit G.

    Initiation of LTFV Investigation

    Based upon the examination of the Petition, we find that the Petition meets the requirements of section 732 of the Act. Therefore, we are initiating an AD investigation to determine whether imports of aluminum wire and cable from China are being, or are likely to be, sold in the United States at LTFV. In accordance with section 733(b)(1)(A) of the Act and 19 CFR 351.205(b)(1), unless postponed, we will make our preliminary determination no later than 140 days after the date of this initiation.

    Respondent Selection

    The petitioners named 27 producers/exporters as accounting for the majority of exports of aluminum wire and cable to the United States from China.38 In accordance with our standard practice for respondent selection in AD cases involving NME countries, we intend to issue quantity and value (Q&V) questionnaires to producers/exporters of merchandise subject to this investigation. In the event Commerce determines that it cannot individually examine each company, where appropriate, Commerce intends to select mandatory respondents based on the responses received to its Q&V questionnaire. Commerce will request Q&V information from known exporters and producers identified with complete contact information in the Petition. In addition, Commerce will post the Q&V questionnaires along with filing instructions on Enforcement and Compliance's website at http://www.trade.gov/enforcement/news.asp.

    38See Volume I of the Petition, at 24; see also Volume II of the Petition, at Exhibits GEN-16 and GEN-20.

    Producers/exporters of aluminum wire and cable from China that do not receive Q&V questionnaires by mail may still submit a response to the Q&V questionnaire and can obtain a copy of the Q&V questionnaire from Enforcement & Compliance's website. The Q&V questionnaire response must be submitted by the relevant Chinese exporters/producers no later than 5:00 p.m. ET on October 25, 2018, which is two weeks from the signature date of this notice. All Q&V responses must be filed electronically via ACCESS.

    Separate Rates

    In order to obtain separate-rate status in an NME investigation, exporters and producers must submit a separate-rate application.39 The specific requirements for submitting a separate-rate application in this investigation are outlined in detail in the application itself, which is available on Commerce's website at http://enforcement.trade.gov/nme/nme-sep-rate.html. The separate-rate application will be due 30 days after publication of this initiation notice.40 Exporters and producers who submit a separate-rate application and have been selected as mandatory respondents will be eligible for consideration for separate-rate status only if they respond to all parts of Commerce's AD questionnaire as mandatory respondents. Commerce requires that companies from China submit a response to both the Q&V questionnaire and the separate-rate application by the respective deadlines in order to receive consideration for separate-rate status. Companies not filing a timely Q&V questionnaire response will not receive separate-rate consideration.

    39See Policy Bulletin 05.1: Separate-Rates Practice and Application of Combination Rates in Antidumping Investigation involving Non-Market Economy Countries (April 5, 2005), available at http://enforcement.trade.gov/policy/bull05-1.pdf (Policy Bulletin 05.1).

    40 Although in past investigations this deadline was 60 days, consistent with 19 CFR 351.301(a), which states that “the Secretary may request any person to submit factual information at any time during a proceeding,” this deadline is now 30 days.

    Use of Combination Rates

    Commerce will calculate combination rates for certain respondents that are eligible for a separate rate in an NME investigation. The Separate Rates and Combination Rates Bulletin states:

    {w}hile continuing the practice of assigning separate rates only to exporters, all separate rates that the Department will now assign in its NME Investigation will be specific to those producers that supplied the exporter during the period of investigation. Note, however, that one rate is calculated for the exporter and all of the producers which supplied subject merchandise to it during the period of investigation. This practice applies both to mandatory respondents receiving an individually calculated separate rate as well as the pool of non-investigated firms receiving the weighted-average of the individually calculated rates. This practice is referred to as the application of “combination rates” because such rates apply to specific combinations of exporters and one or more producers. The cash-deposit rate assigned to an exporter will apply only to merchandise both exported by the firm in question and produced by a firm that supplied the exporter during the period of investigation.41

    41See Policy Bulletin 05.1 at 6 (emphasis added).

    Distribution of Copies of the Petition

    In accordance with section 732(b)(3)(A) of the Act and 19 CFR 351.202(f), copies of the public version of the Petition have been provided to the government of China via ACCESS. To the extent practicable, we will attempt to provide a copy of the public version of the Petition to each exporter named in the Petition, as provided under 19 CFR 351.203(c)(2).

    ITC Notification

    We will notify the ITC of our initiation, as required by section 732(d) of the Act.

    Preliminary Determination by the ITC

    The ITC will preliminarily determine, within 45 days after the date on which the Petition was filed, whether there is a reasonable indication that imports of aluminum wire and cable from China are materially injuring or threatening material injury to a U.S. industry.42 A negative ITC determination will result in the investigation being terminated.43 Otherwise, the investigation will proceed according to statutory and regulatory time limits.

    42See section 733(a) of the Act.

    43Id.

    Submission of Factual Information

    Factual information is defined in 19 CFR 351.102(b)(21) as: (i) Evidence submitted in response to questionnaires; (ii) evidence submitted in support of allegations; (iii) publicly available information to value factors under 19 CFR 351.408(c) or to measure the adequacy of remuneration under 19 CFR 351.511(a)(2); (iv) evidence placed on the record by Commerce; and (v) evidence other than factual information described in (i)-(iv). Section 351.301(b) of Commerce's regulations requires any party, when submitting factual information, to specify under which subsection of 19 CFR 351.102(b)(21) the information is being submitted 44 and, if the information is submitted to rebut, clarify, or correct factual information already on the record, to provide an explanation identifying the information already on the record that the factual information seeks to rebut, clarify, or correct.45 Time limits for the submission of factual information are addressed in 19 CFR 351.301, which provides specific time limits based on the type of factual information being submitted. Interested parties should review the regulations prior to submitting factual information in this investigation.

    44See 19 CFR 351.301(b).

    45See 19 CFR 351.301(b)(2).

    Extensions of Time Limits

    Parties may request an extension of time limits before the expiration of a time limit established under 19 CFR 351.301, or as otherwise specified by the Secretary. In general, an extension request will be considered untimely if it is filed after the expiration of the time limit established under 19 CFR 351.301. For submissions that are due from multiple parties simultaneously, an extension request will be considered untimely if it is filed after 10:00 a.m. ET on the due date. Under certain circumstances, we may elect to specify a different time limit by which extension requests will be considered untimely for submissions which are due from multiple parties simultaneously. In such a case, we will inform parties in a letter or memorandum of the deadline (including a specified time) by which extension requests must be filed to be considered timely. An extension request must be made in a separate, stand-alone submission; under limited circumstances we will grant untimely-filed requests for the extension of time limits. Parties should review Extension of Time Limits; Final Rule, 78 FR 57790 (September 20, 2013), available at http://www.thefederalregister.org/fdsys/pkg/FR-2013-09-20/html/2013-22853.htm, prior to submitting factual information in this investigation.

    Certification Requirements

    Any party submitting factual information in an AD or CVD proceeding must certify to the accuracy and completeness of that information.46 Parties must use the certification formats provided in 19 CFR 351.303(g).47 Commerce intends to reject factual submissions if the submitting party does not comply with the applicable certification requirements.

    46See section 782(b) of the Act.

    47See also Certification of Factual Information to Import Administration During Antidumping and Countervailing Duty Proceedings, 78 FR 42678 (July 17, 2013) (Final Rule). Answers to frequently asked questions regarding the Final Rule are available at http://enforcement.trade.gov/tlei/notices/factual_info_final_rule_FAQ_07172013.pdf.

    Notification to Interested Parties

    Interested parties must submit applications for disclosure under APO in accordance with 19 CFR 351.305. On January 22, 2008, Commerce published Antidumping and Countervailing Duty Proceedings: Documents Submission Procedures; APO Procedures, 73 FR 3634 (January 22, 2008). Parties wishing to participate in this investigation should ensure that they meet the requirements of these procedures (e.g., the filing of letters of appearance as discussed at 19 CFR 351.103(d)).

    This notice is issued and published pursuant to sections 732(c)(2) and 777(i) of the Act, and 19 CFR 351.203(c).

    Dated: October 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. Appendix I Scope of the Investigation

    The scope of the investigation covers aluminum wire and cable, which is defined as an assembly of one or more electrical conductors made from 8000 Series Aluminum Alloys (defined in accordance with ASTM B800), Aluminum Alloy 1350 (defined in accordance with ASTM B230/B230M or B609/B609M), and/or Aluminum Alloy 6201 (defined in accordance with ASTM B398/B398M), provided that: (1) At least one of the electrical conductors is insulated; (2) each insulated electrical conductor has a voltage rating greater than 80 volts and not exceeding 1000 volts; and (3) at least one electrical conductor is stranded and has a size not less than 16.5 thousand circular mil (kcmil) and not greater than 1000 kcmil. The assembly may: (1) Include a grounding or neutral conductor; (2) be clad with aluminum, steel, or other base metal; or (3) include a steel support center wire, one or more connectors, a tape shield, a jacket or other covering, and/or filler materials.

    Most aluminum wire and cable products conform to National Electrical Code (NEC) types THHN, THWN, THWN-2, XHHW-2, USE, USE-2, RHH, RHW, or RHW-2, and also conform to Underwriters Laboratories (UL) standards UL-44, UL-83, UL-758, UL-854, UL-1063, UL-1277, UL-1569, UL-1581, or UL-4703, but such conformity is not required for the merchandise to be included within the scope.

    The scope of the investigation specifically excludes conductors that are included in equipment already assembled at the time of importation. Also excluded are aluminum wire and cable products in actual lengths less than six feet.

    The merchandise covered by the investigation is currently classifiable under subheading 8544.49.9000 of the Harmonized Tariff Schedule of the United States (HTSUS). Products subject to the scope may also enter under HTSUS subheading 8544.42.9090. The HTSUS subheadings are provided for convenience and customs purposes. The written description of the scope of the investigation is dispositive.

    [FR Doc. 2018-22656 Filed 10-17-18; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE National Institute of Standards and Technology Open Meeting of the Information Security and Privacy Advisory Board AGENCY:

    National Institute of Standards and Technology, Department of Commerce.

    ACTION:

    Notice.

    SUMMARY:

    The Information Security and Privacy Advisory Board (ISPAB) will meet Thursday, November 01, 2018 from 9:00 a.m. until 5:00 p.m., Eastern Time, and Friday, November 02, 2018 from 9:00 a.m. until 4:30 p.m. Eastern Time. All sessions will be open to the public.

    DATES:

    The meeting will be held on Thursday, November 01, 2018, from 9:00 a.m. until 5:00 p.m., Eastern Time, and Friday, November 02, 2018, from 9:00 a.m. until 4:30 p.m. Eastern Time.

    ADDRESSES:

    The meeting will be held at the American University Washington College of Law, 4300 Nebraska Ave. NW, Washington, DC, 20016.

    FOR FURTHER INFORMATION CONTACT:

    Jeff Brewer, Information Technology Laboratory, NIST, 100 Bureau Drive, Stop 8930, Gaithersburg, MD 20899-8930, Telephone: (301) 975-2489, Email address: [email protected].

    SUPPLEMENTARY INFORMATION:

    Pursuant to the Federal Advisory Committee Act, as amended, 5 U.S.C. App., notice is hereby given that the ISPAB will meet Thursday, November 01, 2018, from 9:00 a.m. until 5:00 p.m., Eastern Time, and Friday, November 02, 2018 from 9:00 a.m. until 4:30 p.m. Eastern Time. All sessions will be open to the public. The ISPAB is authorized by 15 U.S.C. 278g-4, as amended, and advises the National Institute of Standards and Technology (NIST), the Secretary of Homeland Security, and the Director of the Office of Management and Budget (OMB) on information security and privacy issues pertaining to Federal government information systems, including thorough review of proposed standards and guidelines developed by NIST. Details regarding the ISPAB's activities are available at http://csrc.nist.gov/groups/SMA/ispab/index.html.

    The agenda is expected to include the following items:

    —Deliberations and discussions by the ISPAB on security and privacy issues, —Presentation and discussion on NIST cybersecurity standards and guidance, —Briefings from the Department of Homeland Security National Risk Management Center, —Presentation and discussion on supply chain risk management programs, —Briefing from NIST on Internet of Things (IOT) guidance, —Presentation and discussion on the draft roadmap from the Report to the President on Enhancing the Resilience of the internet and Communications Ecosystem Against Botnets and Other Automated, Distributed Threats (May 22, 2018), —Presentation and discussion on cybersecurity and privacy issues related to Quantum Computing, —Presentation and discussion on the NIST privacy framework program, and —Updates on NIST Information Technology Laboratory cybersecurity work.

    Note that agenda items may change without notice. The final agenda will be posted on the website indicated above. Seating will be available for the public and media. Pre-registration is not required to attend this meeting.

    Public Participation: The ISPAB agenda will include a period, not to exceed thirty minutes, for oral comments from the public (Thursday, November 01, 2018, between 4:30 p.m. and 5:00 p.m.). Speakers will be selected on a first-come, first-served basis. Each speaker will be limited to five minutes. Questions from the public will not be considered during this period. Members of the public who are interested in speaking are requested to contact Jeff Brewer at the contact information indicated in the FOR FURTHER INFORMATION CONTACT section of this notice.

    Speakers who wish to expand upon their oral statements, those who had wished to speak but could not be accommodated on the agenda, and those who were unable to attend in person are invited to submit written statements. In addition, written statements are invited and may be submitted to the ISPAB at any time. All written statements should be directed to the ISPAB Secretariat, Information Technology Laboratory, 100 Bureau Drive, Stop 8930, National Institute of Standards and Technology, Gaithersburg, MD 20899-8930.

    Kevin A. Kimball, Chief of Staff.
    [FR Doc. 2018-22735 Filed 10-17-18; 8:45 am] BILLING CODE 3510-13-P
    BUREAU OF CONSUMER FINANCIAL PROTECTION Supervisory Highlights: Summer 2018 AGENCY:

    Bureau of Consumer Financial Protection.

    ACTION:

    Supervisory Highlights; notice.

    SUMMARY:

    The Bureau of Consumer Financial Protection (Bureau) is issuing its seventeenth edition of its Supervisory Highlights. In this issue of Supervisory Highlights, we report examination findings in the areas of auto finance lending; credit card account management; debt collection; deposits; mortgage servicing; mortgage origination; service providers; short-term, small-dollar lending; remittances; and fair lending. As in past editions, this report includes information on the Bureau's use of its supervisory and enforcement authority, recently released examination procedures, and Bureau guidance.

    DATES:

    The Bureau released this edition of the Supervisory Highlights on its website on September 06, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Adetola Adenuga, Consumer Financial Protection Analyst, Office of Supervision Policy, at (202) 435-9373. If you require this document in an alternative electronic format, please contact [email protected].

    SUPPLEMENTARY INFORMATION: 1. Introduction

    The Bureau of Consumer Financial Protection (Bureau) is committed to a consumer financial marketplace that is free, innovative, competitive, and transparent, where the rights of all parties are protected by the rule of law, and where consumers are free to choose the products and services that best fit their individual needs. To effectively accomplish this, the Bureau remains committed to sharing with the public key findings from its supervisory work to help industry limit risks to consumers and comply with Federal consumer financial law.

    The findings included in this report cover examinations in the areas of automobile loan servicing, credit cards, debt collection, mortgage servicing, payday lending, and small business lending that were generally completed between December 2017 and May 2018 (unless otherwise stated).

    It is important to keep in mind that institutions are subject only to the requirements of relevant laws and regulations. The information contained in Supervisory Highlights is disseminated to help institutions better understand how the Bureau examines institutions for compliance with those requirements. This document does not impose any new or different legal requirements. In addition, the legal violations described in this and previous issues of Supervisory Highlights are based on the particular facts and circumstances reviewed by the Bureau as part of its examinations. A conclusion that a legal violation exists on the facts and circumstances described here may not lead to such a finding under different facts and circumstances. We invite readers with questions or comments about the findings and legal analysis reported in Supervisory Highlights to contact us at [email protected].

    2. Supervisory Observations

    Recent supervisory observations are reported in the areas of automobile loan servicing, credit cards, debt collection, mortgage servicing, payday lending, and, for the first time, small business lending.

    2.1 Automobile Loan Servicing

    The Bureau continues to examine auto loan servicing activities, primarily to assess whether servicers have engaged in unfair, deceptive, or abusive acts or practices prohibited by the Consumer Financial Protection Act of 2010 (CFPA). Recent auto loan servicing examinations identified deceptive and unfair acts or practices related to billing statements and wrongful repossessions.

    2.1.1 Billing Statements Showing Paid-Ahead Status After Applying Insurance Proceeds

    One or more examinations observed instances in which notes required that insurance proceeds from a total vehicle loss be applied as a one-time payment to the loan with any remaining balance to be collected according to the consumer's regular billing schedule. However, in some instances after consumers experienced a total vehicle loss, the servicers sent billing statements showing that the insurance proceeds had been applied to the loan payments so that the loan was paid ahead and that the next payment on the remaining balance was due many months or years in the future. Servicers then treated consumers who failed to pay by the next month as late and in some cases also reported the negative information to consumer reporting agencies.

    The examination found that servicers engaged in a deceptive practice by sending billing statements indicating that consumers did not need to make a payment until a future date when in fact the consumer needed to make a monthly payment.1 The billing statements contained due dates inconsistent with the note and the servicer's insurance payment application. Such information would mislead reasonable consumers to think they did not need to make the next monthly payment. The misrepresentation is material because it likely affected consumers' conduct with regard to auto loans. Consumers would have been more likely to make a monthly payment if they knew that not doing so would result in a late fee, delinquency notice, or adverse credit reporting. In response to examination findings, the servicers are sending billing statements that accurately reflect the account status of the loan after applying insurance proceeds from a total vehicle loss.

    1 12 U.S.C. 5531, 5536.

    2.1.2 Repossessions

    Many auto servicers provide options to consumers to avoid repossession once a loan is delinquent or in default. Servicers may offer formal extension agreements that allow consumers to forbear payments for a certain period of time or may cancel a repossession order once a consumer makes a payment.

    One or more recent examinations found that servicers repossessed vehicles after the repossession was supposed to be cancelled. In these instances, the servicers incorrectly coded the account as remaining delinquent or customer service representatives did not timely cancel the repossession order after the consumer's agreement with the servicers to avoid repossession. The examinations identified this as an unfair practice.2 The practice of wrongfully repossessing vehicles causes substantial injury because it deprives borrowers of the use of their vehicles and potentially leads to additional associated harm, such as lost wages and adverse credit reporting. Such injury is not reasonably avoidable when consumers take action they believed would halt the repossession and there is no additional action the borrower can take to prevent it. Finally, the injury is not outweighed by countervailing benefits to the consumer or to competition. No benefits to competition are apparent from erroneous repossessions. And the expense to better monitor repossession activity is unlikely to be substantial enough to affect institutional operations or pricing. In response to the examination findings, the servicers are stopping the practice, reviewing the accounts of consumers affected by a wrongful repossession, and removing or remediating all repossession-related fees.

    2Id.

    2.2 Credit Cards

    The Bureau continues to examine the credit card account management operations of one or more supervised entities. Typically, examinations assess advertising and marketing, account origination, account servicing, payments and periodic statements, dispute resolution, and the marketing, sale and servicing of credit card add-on products. With some notable exceptions, the examinations found that supervised entities generally are complying with applicable Federal consumer financial laws.

    2.2.1 Periodic Re-Evaluation of Rate Increases

    Regulation Z, as revised to implement the Card Accountability Responsibility and Disclosure (CARD) Act, requires credit card issuers to periodically re-evaluate consumer credit card accounts subjected to certain increases in the applicable Annual Percentage Rate(s) (APR or rate) to assess whether it is appropriate to reduce the account's APR(s).3 Issuers must first re-evaluate each such account no later than six months after the rate increase and at least every six months thereafter.4 In re-evaluating each account, the issuer must apply either (a) the factors on which the rate increase was originally based or (b) the factors the issuer currently considers when determining the APR applicable to similar, new consumer credit card accounts.5

    3 12 CFR 1026.59(a).

    4 12 CFR 1026.59(c).

    5 12 CFR 1026.59(d)(1).

    One or more examinations between January and July 2018 found that entities: (a) Failed to re-evaluate all eligible accounts, (b) failed to consider the appropriate factors when re-evaluating eligible accounts, or (c) failed to appropriately reduce the rates of accounts eligible for rate reduction. In one or more instances, the issuers failed to re-evaluate all eligible accounts because they inadvertently excluded some eligible accounts from the pool of accounts they re-evaluated. In one or more instances, the issuers failed to consider the appropriate factors because they inappropriately conflated re-evaluation factors, among other reasons. In one or more instances, the issuers failed to appropriately reduce the rates for eligible accounts because they effectively imposed additional criteria for a rate reduction. The issuers have undertaken, or developed plans to undertake, remedial and corrective actions in response to these examination findings.

    2.3 Debt Collection

    The Bureau's Supervision program has authority to examine certain entities that engage in consumer debt collection activities, including nonbanks that are larger participants in the consumer debt collection market. Recent examinations of larger participants identified one or more violations of the Fair Debt Collection Practices Act (FDCPA).6

    6 15 U.S.C. 1692-1692p.

    2.3.1 Failure To Obtain and Mail Debt Verification Before Engaging in Further Collection Activities

    Section 809(b) of the FDCPA requires a debt collector, upon receipt of a written debt validation request from a consumer, to cease collection of the debt until it obtains verification of the debt and mails it to the consumer.7 Examinations found that one or more debt collectors routinely failed to mail debt verifications before engaging in further collections activities. Instead, one or more debt collectors forwarded consumer debt validation requests to originating creditors; the creditors then reviewed the debts and mailed responses directly to consumers. One or more debt collectors accepted creditor determinations that the debt was owed by the relevant consumer for the amount claimed without receiving information verifying the debt and without mailing the required verification to consumers. One or more debt collectors then continued collection activities on accounts in violation of section 809(b) of the FDCPA.8 In response to these examination findings, one or more debt collectors are revising their debt validation policies, procedures, and practices to ensure both that they obtain appropriate verification of the debt when requested and that they mail the verification to consumers prior to engaging in further collection activities.

    7 15 U.S.C. 1692g(b).

    8Id.

    2.4 Mortgage Servicing

    Bureau examinations continue to focus on the loss mitigation process and, in particular, on how servicers handle trial modifications where consumers are paying as agreed. One or more recent mortgage servicing examinations observed unfair acts or practices relating to conversion of trial modifications to permanent status and initiation of foreclosures after consumers accepted loss mitigation offers. Recent examinations also identified unfair acts or practices when institutions charged consumers amounts not authorized by modification agreements or by mortgage notes.

    2.4.1 Converting Trial Modifications to Permanent Status

    Past editions of Supervisory Highlights discussed how one or more servicers failed to place consumers who successfully completed trial modifications into permanent modifications in a timely manner.9 Such delays may harm consumers when interest accrues at a higher non-modified rate or when servicers report consumers as delinquent or still in trial modifications to consumer reporting agencies during the delay. Where a servicer does not provide full financial remediation to the consumer for such a delay, one or more examinations have identified an unfair practice.

    9See, e.g., Issue 11 of Supervisory Highlights, section 3.2, available at, https://www.consumerfinance.gov/documents/509/Mortgage_Servicing_Supervisory_Highlights_11_Final_web_.pdf.

    One or more recent examinations reviewed the practices of servicers with policies providing for permanent modifications of loans if consumers made four timely trial modification payments. However, for nearly 300 consumers who successfully completed the trial modification, the servicers delayed processing the permanent modification for more than 30 days. During these delays, consumers accrued interest and fees that would not have been accrued if the permanent modification had been processed. The servicers did not remediate all of the affected consumers nor did they have policies or procedures for remediating consumers in such circumstances. The servicers attributed the modification delays to insufficient staffing.

    As a result, one or more examinations identified an unfair act or practice. Consumers experienced substantial injury that could not be reasonably avoided. The accrued fees and interest that the servicers failed to fully remediate were likely significant because the delays were more than 30 days. And consumers could not reasonably avoid these injuries. They could neither control the processing of their loan modifications nor compel remediation from the servicers. The harm to consumers outweighs the cost to consumers or to competition, given that the servicers acknowledged that the delay was in error and did not indicate that the cost of remediation was burdensome. In response to examination findings, the servicers are fully remediating affected consumers and developing and implementing policies and procedures to timely convert trial modifications to permanent modifications where the consumers have met the trial modification conditions.10

    10 12 U.S.C. 5531, 5536.

    In September 2017, examinations also found that one or more servicers mitigated the potential consumer harm associated with trial conversion delays by maintaining communication with consumers during the delay and by proactively remediating individual consumers for the costs associated with the delay after eventually making the consumers' modifications permanent.

    2.4.2 Charging Consumers Unauthorized Amounts

    One or more examinations found instances in which mortgage servicers charged consumers more than the amounts authorized by their loan modification agreements. The overcharges were caused by data errors affecting the modified loan's starting balance, step-rate and interest-rate changes, deferred interest, and amortization maturity date when the loan was entered into the servicing system. The examinations identified this as an unfair practice.11 The overcharges resulted in substantial injury to consumers when consumers made payments higher than those stipulated in the modification agreements or when they made payments for a term longer than stipulated in the modification agreements. Consumers could not reasonably avoid this injury, which was caused by errors in the servicers' systems. The injury to consumers is not outweighed by any countervailing benefits to consumers or to competition. No benefits to competition are apparent from the systemic errors that resulted in erroneous billing statements. And the expense of instituting validation procedures for loan-modification data is unlikely to be substantial enough to affect institutional operations or pricing. In response to the examination findings, the servicers are remediating affected consumers and correcting loan modification terms in their systems.

    11 12 U.S.C. 5531, 5536.

    2.4.3 Representations Regarding Initiation of Foreclosure

    When one or more mortgage servicers approved borrowers for a loss mitigation option on a non-primary residence, the servicers represented to borrowers that the servicers would not initiate foreclosure if the borrower accepted loss mitigation offers in writing or by phone by a specified date. However, the servicers then initiated foreclosure even if borrowers had called or written to accept the loss mitigation offers by that date. Examinations identified this as a deceptive act or practice.

    The misrepresentations were likely to mislead borrowers when the servicers expressly indicated that the servicers would not initiate foreclosure proceedings if borrowers accepted the loss mitigation offers. The borrowers' interpretation of the misrepresentations was reasonable in this circumstance, i.e., that the servicers would not initiate foreclosure after the borrowers accepted the loss mitigation offers. The misrepresentations were material because they were likely to prompt borrowers to accept the loss mitigation offers to avoid the initiation of foreclosure proceedings.

    2.4.4 Representations Regarding Foreclosure Sales

    Examinations observed that when borrowers submitted complete loss mitigation applications less than 37 days from a scheduled foreclosure sale date, one or more servicers sent the borrowers notices indicating that the applications were complete and stating that the servicer(s) would notify the borrowers of the decision on the applications in writing within 30 days. But after sending these notices, the servicers proceeded to conduct the scheduled foreclosure sales without making a decision on the borrowers' loss mitigation applications.

    The examinations did not find that this conduct amounted to a legal violation but observed that it could pose a risk of a deceptive practice. The notices could potentially mislead borrowers by stating that the borrowers would receive a decision on their loss mitigation applications. Borrowers reasonably could take that statement to mean that foreclosure sales would be postponed until a decision was reached.

    2.5 Payday Lending

    The Bureau's Supervision program covers entities that offer or provide payday loans. Examinations of payday lenders identified unfair and deceptive acts or practices as well as violations of Regulation E.12

    12 12 CFR 1005.10(b).

    2.5.1 Misleading Collection Letters

    Examinations observed one or more entities engaging in a deceptive act or practice in their collection letters. These entities represented in their letters that they will, or may have no choice but to, repossess consumers' vehicles if the consumers fail to make payments or contact the entities. This was despite the fact that these entities did not have business relationships with any party to repossess vehicles and, as a general matter, did not repossess vehicles. Given these facts, the examination concluded that the net impression of these representations in the context of each letter was to mislead consumers to believe that these entities would repossess or were likely to repossess consumers' vehicles. The representations were material because they were likely to affect the behavior of consumers who were misled. The representations were likely to induce consumers to make payments to these entities, as opposed to allocating their funds toward other expenses. In response to the examination findings, the entity or entities are ensuring that their collection letters do not contain deceptive content.

    2.5.2 Debiting Consumers' Accounts Without Valid Authorization by Using Account Information Previously Provided for Other Purposes

    Examinations observed one or more entities using debit card numbers or Automated Clearing House (ACH) credentials that consumers had not validly authorized the entities to use to debit funds in connection with a single-payment or installment loan in default. Upon a consumer's failure to repay the loan obligation as agreed, one or more entities attempted to initiate electronic fund transfers (EFTs) using debit card numbers or ACH credentials that borrowers had identified on authorization forms executed in connection with the defaulted loan at issue. If those attempts were unsuccessful, the entities would then seek to collect balances due and owing via EFTs using debit card numbers or ACH credentials that the borrowers had supplied to the entities for other purposes, such as when obtaining other loans or making one-time payments on other loans or the loan at issue. Through these invalidly authorized EFTs, the entities sought payment of up to the entire amount due on the loan.

    The examinations identified these as unfair acts or practices and also, in some cases, as violations of Regulation E. With respect to unfairness, the invalidly authorized debits caused substantial injury in the form of debits that consumers could not anticipate, leading to potential fees. Because the credentials were provided to the entities for other purposes, such as account information consumers provided in previous credit applications, consumers could not anticipate that the entities would use them for the defaulted loan at issue and thus could not reasonably avoid such injury. Finally, the injury was not outweighed by any countervailing benefits to consumers, such as satisfying their debts, or to competition, such as passing on lower costs to consumers derived from easier debt collection. By giving an unfair advantage over other entities that obtain authorization to initiate debits from consumers pursuant to clear and readily understandable terms, the unfair acts or practices likely harmed competition.13

    13 12 U.S.C. 5531, 5536.

    With respect to loans for which the consumer entered into preauthorized EFTs that recurred at substantially regular intervals, the examinations identified this practice as a violation of Regulation E, which requires that preauthorized EFTs from a consumer's account be authorized only by a writing signed or similarly authenticated by the consumer.14 Here, the loan agreements and EFT authorization forms failed to provide clear and readily understandable terms regarding the entities' use of debit card numbers or ACH credentials that consumers provided for other purposes. Accordingly, the entities did not obtain valid preauthorized EFT authorizations for the debits they initiated using debit card numbers or ACH credentials consumers provided for other purposes.

    14 12 CFR 1005.10(b).

    In response to examination findings, the entity or entities are ceasing the violations, remediating borrowers impacted by the invalid EFTs, and revising loan agreement templates and ACH authorization forms.

    2.6 Small Business Lending

    The Equal Credit Opportunity Act (ECOA) prohibition against discrimination is not limited to consumer transactions; it also applies to business-purpose credit transactions, including credit extended to small businesses. In 2016 and 2017, the Bureau began conducting supervision work to assess ECOA compliance in institutions' small business lending product lines, focusing in particular on the risks of an ECOA violation in underwriting, pricing, and redlining. The Bureau anticipates an ongoing dialogue with supervised institutions and other stakeholders as the Bureau moves forward with supervision work in small business lending.

    2.6.1 Supervisory Observations

    In the course of conducting ECOA small business lending reviews, Bureau examination teams have observed instances in which one or more financial institutions effectively managed the risks of an ECOA violation in their small business lending programs.

    Examinations at one or more institutions observed that the board of directors and management maintained active oversight over the institutions' compliance management system (CMS) framework. Institutions developed and implemented comprehensive risk-focused policies and procedures for small business lending originations and actively addressed the risks of an ECOA violation by conducting periodic reviews of small business lending policies and procedures and by revising those policies and procedures as necessary. Examinations also observed that one or more institutions maintained a record of policy and procedure updates to ensure that they were kept current.

    With regard to self-monitoring, one or more institutions implemented small business lending monitoring programs and conducted semi-annual ECOA risk assessments that include assessments of small business lending. In addition, one or more institutions actively monitored pricing-exception practices and volume through a committee.

    When examinations included file reviews of manual underwriting overrides at one or more institutions, they found that credit decisions made by the institutions were consistent with the requirements of ECOA, and thus the examinations did not find any violations of ECOA.

    At one or more institutions, however, examinations observed that institutions collect and maintain (in useable form) only limited data on small business lending decisions. Limited availability of data could impede an institution's ability to monitor and test for the risks of ECOA violations through statistical analyses.

    3. Remedial Actions 3.1 Public Enforcement Actions

    The Bureau's supervisory activities resulted in or supported the following public enforcement actions.

    3.1.1 Citibank N.A.

    On June 29, 2018, the Bureau announced an enforcement action against Citibank, N.A., (Citibank or Bank). The Bureau found Citibank violated the Truth in Lending Act (TILA) and its implementing regulation, Regulation Z, by failing to properly periodically re-evaluate and reduce the Annual Percentage Rates (rates) applicable to credit card accounts that had been subject to certain rate increases between 2011 and 2017 and by failing to have in place reasonable written policies and procedures to do so.

    In 2016, Citibank initiated a significant compliance review program across its credit cards line of business. That review led to Citibank's self-identifying several deficiencies and errors in its rate re-evaluation methodologies. After the Bank promptly self-disclosed the violations, the Bureau ultimately found through its supervisory process that Citibank violated TILA by failing to reevaluate and reduce the APRs for approximately 1.75 million consumer credit card accounts and thereby imposed on those accounts excess interest charges of $335 million.

    Under the terms of the resulting consent order, Citibank was required to correct these practices and pay $335 million in restitution to the impacted consumers.15 The Bureau did not assess civil money penalties based on a number of factors, including Citibank's self-identifying and self-reporting the violations to the Bureau and its self-initiating remediation to affected consumers.

    15See Citibank Consent Order available at, https://www.consumerfinance.gov/about-us/newsroom/bureau-consumer-financial-protection-settles-citibank-na/.

    3.1.2 Triton Management Group

    On July 19, 2018, the Bureau entered into a consent order with Triton Management Group, Inc., a payday lender that operates in Alabama, Mississippi, and South Carolina under several names including “Always Money” and “Quik Pawn Shop.” The Bureau found that Triton violated the CFPA and the disclosure requirements of TILA by failing to properly disclose finance charges associated with their auto title loans in Mississippi. The Bureau also found that Triton used advertisements that failed to disclose the annual percentage rate and other information in violation of TILA. The consent order bars Triton from misrepresenting the costs of its loans and requires Triton to remediate consumers $1,522,298. Based on Triton's inability to pay, it will remediate consumers $500,000.16

    16See Triton Management Group Consent Order available at, https://www.consumerfinance.gov/about-us/newsroom/bureau-consumer-financial-protection-settles-triton-management-group/.

    Supervision Program Developments 3.2 Recent Bureau Rules and Guidance 3.2.1 Mortgage Servicing Final Rule

    On March 8, 2018, the Bureau issued a final rule to help mortgage servicers communicate with certain borrowers facing bankruptcy. The final rule gives mortgage servicers a clearer and more straightforward standard for providing periodic statements to consumers entering or exiting bankruptcy by amending the Bureau's 2016 mortgage servicing rule. Specifically, the final rule provides a clear single-statement exemption for servicers to make the transition, superseding the single-billing-cycle exemption included in the 2016 rule. The effective date for the rule was April 19, 2018.17

    17See Mortgage Service Rules under the Truth in Lending Act (Regulation Z), 83 FR 10553 (Mar. 8, 2018), https://files.consumerfinance.gov/f/documents/cfpb_mortgage-servicing_final-rule_2018-amendments.pdf.

    3.2.2 2017-2018 Amendments of the TILA-RESPA Integrated Disclosure Rule

    On August 11, 2017, the Bureau published a final rule 18 in the Federal Register amending the Federal mortgage disclosure requirements under the Real Estate Settlement Procedures Act (RESPA) and the Truth in Lending Act (TILA) as implemented by Regulation Z (2017 TILA-RESPA Rule). These amendments are intended to provide greater certainty and clarity to the 2013 TILA-RESPA Rule, which went into effect on October 3, 2015. Changes and clarifications in the 2017 TILA-RESPA Rule include creating a tolerance for the total of payments disclosure, clarifying the partial exemption for housing assistance lending, expanding coverage of the disclosure rule to include operative units regardless of whether State law considers the units real property or personal property, and clarifying when disclosures may be shared with third parties. Additionally, the 2017 TILA-RESPA Rule includes several additional clarifications and technical changes addressing various parts of the 2013 TILA-RESPA Rule, including the calculating cash to close table, construction-to-permanent lending, principal reductions, rounding requirements, and simultaneous second lien loans. The 2017 TILA-RESPA Rule became effective October 10, 2017. However, compliance with the 2017 TILA-RESPA Rule is mandatory only with respect to transactions for which a creditor or mortgage broker receives an application on or after October 1, 2018 (except for compliance with the escrow cancellation notice 19 and compliance with the partial payment policy disclosure requirements,20 which will become mandatory on October 1, 2018, regardless of when an application was received).

    18 Amendments to Federal Mortgage Disclosure Requirements under the Truth in Lending Act (Regulation Z), 82 FR (Aug. 11, 2017).

    19 12 CFR 1026.20(e).

    20 12 CFR 1026.39(d)(5).

    On May 2, 2018, the Bureau published a final rule in the Federal Register amending the Federal mortgage disclosure requirements to address when a creditor may use a Closing Disclosure to determine if an estimated closing cost was disclosed in good faith and within tolerance (2018 TILA-RESPA Rule).21 The 2013 TILA-RESPA Rule in effect as of October 3, 2015 included a timing restriction limiting the use of the Closing Disclosure to reset tolerances to a period relative to the date of consummation, resulting in a creditor's inability to pass through closing cost increases 22 to the consumer in certain limited circumstances. The 2018 TILA-RESPA Rule removes this timing restriction, permitting the use of the Closing Disclosure to establish good faith and reset tolerances regardless of when the Closing Disclosure is provided relative to consummation. The final rule took effect on June 1, 2018.

    21 Federal Mortgage Disclosure Requirements under the Truth in Lending Act (Regulation Z), 83 FR 19159 (May 2, 2018).

    22 12 CFR 1026.19(e)(3)(iv).

    3.3 Fair Lending Developments 3.3.1 HMDA Implementation and New Data Submission Platform

    On December 21, 2017, the Bureau provided the following statement regarding HMDA implementation:

    Recognizing the impending January 1, 2018 effective date of the Bureau's amendments to Regulation C and the significant systems and operational challenges needed to adjust to the revised regulation, for HMDA data collected in 2018 and reported in 2019 the Bureau does not intend to require data resubmission unless data errors are material. Furthermore, the Bureau does not intend to assess penalties with respect to errors in data collected in 2018 and reported in 2019. Collection and submission of the 2018 HMDA data will provide financial institutions an opportunity to identify any gaps in their implementation of amended Regulation C and make improvements in their HMDA CMS for future years. Any examinations of 2018 HMDA data will be diagnostic to help institutions identify compliance weaknesses and will credit good faith compliance efforts. The Bureau intends to engage in a rulemaking to reconsider various aspects of the 2015 HMDA Rule such as the institutional and transactional coverage tests and the rule's discretionary data points. For data collected in 2017, financial institutions will submit their reports in 2018 in accordance with the current Regulation C using the Bureau's HMDA Platform.23

    23CFPB Issues Public Statement on Home Mortgage Disclosure Act Compliance (December 21, 2017), available at https://www.consumerfinance.gov/about-us/newsroom/cfpb-issues-public-statement-home-mortgage-disclosure-act-compliance/.

    On July 5, 2018, the Bureau provided the following statement regarding recent HMDA amendments:

    The President signed the Economic Growth, Regulatory Relief, and Consumer Protection Act (the Act) on May 24, 2018, a section of which amends the Home Mortgage Disclosure Act (HMDA). The Act provides partial exemptions for some insured depository institutions and insured credit unions from certain HMDA requirements.24 The partial exemptions are generally available to insured depository institutions and insured credit unions:

    24 Public Law 115-174, section 104(a) (to be codified at 12 U.S.C. 2803).

    For closed-end mortgage loans if the institution originated fewer than 500 closed-end mortgage loans in each of the two preceding calendar years.

    For open-end lines of credit if the institution originated fewer than 500 open-end lines of credit in each of the two preceding calendar years.

    For closed-end mortgage loans or open-end lines of credit subject to the partial exemptions, the Act states that the “requirements of [HMDA section 304(b)(5) and (6)]” shall not apply. Accordingly, for these transactions, those institutions are exempt from the collection, recording, and reporting requirements for some, but not all, of the data points specified in current Regulation C.

    The Bureau expects to provide further guidance soon on the applicability of the Act to HMDA data collected in 2018.25

    25 The partial exemptions are not available to insured depository institutions that do not meet certain Community Reinvestment Act performance evaluation rating standards. Guidance will include information on how this provision will be implemented.

    For all institutions filing HMDA data collected in 2018, the Act will not affect the format of the LARs:

    LARs will be formatted according to the previously released 2018 Filing Instructions Guide for HMDA Data Collected in 2018 (2018 FIG).26

    26https://s3.amazonaws.com/cfpb-hmda-public/prod/help/2018-hmda-fig.pdf.

    If an institution does not report information for a certain data field due to the Act's partial exemptions, the institution will enter an exemption code for the field specified in a revised 2018 FIG that the Bureau expects to release later this summer.

    All LARs will be submitted to the same HMDA Platform. A beta version of the HMDA Platform for submission of data collected in 2018 will be available later this year for filers to test.

    3.3.2 Small Business Lending Review Procedures

    Each ECOA small business lending review includes a fair lending assessment of the institution's CMS related to small business lending. To conduct this portion of the review, examinations use Module II of the ECOA Baseline Review Modules. CMS reviews include assessments of the institution's board and management oversight, compliance program (policies and procedures, training, monitoring and/or audit, and complaint response), and service provider oversight.

    Examinations also use the Interagency Fair Lending Examination Procedures, which have been adopted in the Bureau's Supervision and Examination Manual. In some ECOA small business lending reviews, examination teams may evaluate an institution's fair lending risks and controls related to origination or pricing of small business lending products. Some reviews may include a geographic distribution analysis of small business loan applications, originations, loan officers, or marketing and outreach, in order to assess potential redlining risk.

    As with other in-depth ECOA reviews, ECOA small business lending reviews may include statistical analysis of lending data in order to identify fair lending risks and appropriate areas of focus during the examination. Notably, statistical analysis is only one factor taken into account by examination teams that review small business lending for ECOA compliance. Reviews typically include other methodologies to assess compliance, including policy and procedure reviews, interviews with management and staff, and reviews of individual loan files.

    3.3.3 FFIEC HMDA Examiner Transaction Testing Guidelines Effective Date

    On August 22, 2017, the Federal Financial Institutions Examination Council (FFIEC) members, including the Bureau, announced new FFIEC Home Mortgage Disclosure Act (HMDA) Examiner Transaction Testing Guidelines for all financial institutions that report HMDA data.27 The Guidelines apply to the examination of HMDA data collected beginning in 2018, which financial institutions must report to the Bureau by March 1, 2019.28

    27 The Guidelines were published by the FFIEC member agencies including the Bureau, the Federal Deposit Insurance Corporation, the Board of Governors of the Federal Reserve System, the National Credit Union Administration, the Office of the Comptroller of the Currency, and the State Liaison Committee. These new Guidelines are available at https://files.consumerfinance.gov/f/documents/201708_cfpb_ffiec-hmda-examiner-transaction-testing-guidelines.pdf.

    28 For HMDA data collected in 2017 and submitted in 2018, the Bureau will follow the HMDA resubmission guidelines published on October 9, 2013 and available at http://files.consumerfinance.gov/f/201310_cfpb_hmda_resubmission-guidelines_fair-lending.pdf.

    3.3.4 Upstart No-Action Letter

    The Bureau is continuing to monitor Upstart Network, Inc. (Upstart) regarding its compliance with the terms of the no-action letter (NAL) it received from Bureau staff. As part of its request for a NAL, Upstart agreed to conduct ongoing fair lending testing of its underwriting model, notify the Bureau before new variables are considered eligible for use in production, and maintain a robust model-related compliance management system.

    In addition to the ongoing fair lending testing discussed above, Upstart agreed as part of its request for a NAL to employ other consumer safeguards. These safeguards, which are described in the application materials posted on the Bureau's website, include ensuring compliance with requirements to provide adverse action notices under Regulation B and the Fair Credit Reporting Act and its implementing regulation, Regulation V, and ensuring that all of its consumer-facing communications are timely, transparent, and clear, and use plain language to convey to consumers the type of information that will be used in underwriting. Upstart has committed to monitoring the effectiveness of all safeguards and sharing the results of its testing, along with other relevant information, with the Bureau during the term of the NAL.

    On July 18, 2018, the Bureau announced the creation of its Office of Innovation, to foster consumer-friendly innovation, which is now a key priority for the Bureau. The Office of Innovation is in the process of revising the Bureau's NAL and trial disclosure policies, in order to increase participation by companies seeking to advance new products and services.

    4. Conclusion

    The Bureau expects that the publication of Supervisory Highlights will continue to aid Bureau-supervised entities in their efforts to comply with Federal consumer financial law. The report shares information regarding general supervisory and examination findings (without identifying specific institutions, except in the case of public enforcement actions), communicates operational changes to the program, and provides a convenient and easily accessible resource for information on the Bureau's guidance documents.

    Dated: September 6, 2018. Mick Mulvaney, Acting Director, Bureau of Consumer Protection.
    [FR Doc. 2018-22726 Filed 10-17-18; 8:45 am] BILLING CODE 4810-AM-P
    DEPARTMENT OF ENERGY DOE/NSF Nuclear Science Advisory Committee AGENCY:

    Office of Science, Department of Energy.

    ACTION:

    Notice of open meeting.

    SUMMARY:

    This notice announces a meeting of the DOE/NSF Nuclear Science Advisory Committee (NSAC). The Federal Advisory Committee Act requires that public notice of these meetings be announced in the Federal Register.

    DATES:

    Friday, November 2, 2018; 8:30 a.m.-4:30 p.m.

    ADDRESSES:

    Crystal City Marriott at Reagan National Airport, 1999 Jefferson Davis Highway, Potomac Ballroom, Arlington, Virginia 22202, 703-413-5500.

    FOR FURTHER INFORMATION CONTACT:

    Brenda L. May, U.S. Department of Energy; SC-26/Germantown Building, 1000 Independence Avenue SW, Washington, DC 20585-1290; Telephone: 301-903-0536 or email: [email protected].

    The most current information concerning this meeting can be found on the website: http://science.gov/np/nsac/meetings/.

    SUPPLEMENTARY INFORMATION:

    Purpose of the Board: The purpose of the Board is to provide advice and guidance on a continuing basis to the Department of Energy and the National Science Foundation on scientific priorities within the field of basic nuclear science research.

    Tentative Agenda: Agenda will include discussions of the following:

    Friday, November 2, 2018 • Perspectives from Department of Energy and National Science Foundation • Update from the Department of Energy and National Science Foundation's Nuclear Physics Office • Presentation of the Mo-99 Charge • Presentation of the Committee of Visitors Charge • NSAC Business/Discussions • Presentation on Physics Case for an Electron Ion Collider • Presentation on Quantum Information Science and Nuclear Physics Note:

    The NSAC Meeting will be broadcast live on the internet. You may find out how to access the broadcast by going to the following site prior to the start of the meeting. A video record of the meeting, including presentations that are made, will be archived at this site after the meeting ends: http://www.tvworldwide.com/events/DOE/181102/.

    Public Participation: The meeting is open to the public. If you would like to file a written statement with the Committee, you may do so either before or after the meeting. If you would like to make oral statements regarding any of these items on the agenda, you should contact Brenda L. May, 301-903-0536 or [email protected] (email). You must make your request for an oral statement at least five business days before the meeting. Reasonable provision will be made to include the scheduled oral statements on the agenda. The Chairperson of the Committee will conduct the meeting to facilitate the orderly conduct of business. Public comment will follow the 10-minute rule.

    Minutes: The minutes of the meeting will be available for review after 60 days on the U.S. Department of Energy's Office of Nuclear Physics website at: http://science.gov/np/nsac/meetings/.

    Signed in Washington, DC on October 4, 2018. LaTanya Butler, Deputy Committee Management Officer.
    [FR Doc. 2018-22734 Filed 10-17-18; 8:45 am] BILLING CODE 6450-01-P
    DEPARTMENT OF ENERGY Distribution of Residual Citronelle Settlement Agreement Funds AGENCY:

    Office of Hearings and Appeals, Department of Energy.

    ACTION:

    Implementation of special refund procedures.

    SUMMARY:

    The Office of Hearings and Appeals (OHA) of the Department of Energy (DOE) finalizes the procedures for the disbursement of residual funds (totaling approximately $59,000) remaining in various Citronelle Settlement Agreement escrow accounts to the parties to the Agreement.

    DATES:

    This plan is applicable October 18, 2018.

    ADDRESSES:

    Inquiries should be sent to the Office of Hearings and Appeals, U.S. Department of Energy, 1000 Independence Ave. SW, Washington, DC 20585-0107, (202) 287-1550, Email: [email protected]

    FOR FURTHER INFORMATION CONTACT:

    Kristin L. Martin, Attorney-Advisor, Office of Hearings and Appeals, U.S. Department of Energy, 1000 Independence Ave. SW, Washington, DC 20585-0107, (202) 287-1550, Email: [email protected]

    SUPPLEMENTARY INFORMATION:

    In this Notice, we announce the final procedures for the distribution of the remaining Citronelle Settlement Agreement Funds.

    The Office of Hearings and Appeals published a Notice of proposed final procedures for the distribution of the Citronelle Settlement Agreement Funds in the Federal Register on September 11, 2018. 83 FR 45916 (September 11, 2018). In the September 11 Notice, we described the history of the Citronelle Settlement Agreement and its relevant contents. We then set forth a proposed plan to distribute the remaining Settlement Agreement funds.

    The Office of Hearings and Appeals provided a 30 day opportunity for public comment on the proposed plan. No comments were submitted during that time. Accordingly, no changes have been made to the final plan.

    Procedure for Final Distribution of Citronelle Settlement Agreement Funds

    The Citronelle Settlement Agreement funds will be distributed according to the following plan. Any funds remaining after the final distributions made in accordance with this plan will be considered unclaimed and will be transferred to the U.S. Treasury. Final distribution amounts will be calculated using the distribution percentages listed in an appendix to this Notice on October 18, 2018.

    A. The Non-Litigant Refiners Account

    The Agreement requires that the balance of the Non-Litigant Refiners account be distributed to the Refiner-Litigants through an escrow account established for that purpose for the initial distribution of Citronelle funds and managed by the law firm Miller & Chevalier. Miller & Chevalier no longer represents the Refiner-Litigants. Further, DOE has not been able to obtain documentation regarding how previous Citronelle distributions were made among the various firms comprising the Refiner-Litigants. In light of these facts and because the Citronelle distribution proportions agreed to by the Refiner-Litigants were not a part of the Agreement and thus not binding on DOE, we propose that the Refiner-Litigant portion of the funds be divided in equal proportions for the firms, or successor firms, listed in Exhibit A of the Agreement. A list of these firms is included as an appendix to this Notice. If a listed firm, or successor firm, does not submit the Required Information described below by the specified deadline, the funds will be considered unclaimed and will be transferred to the U.S. Treasury.

    B. The Airlines Account

    The remaining Airlines account funds will be split according to the percentages prescribed in the Settlement Agreement. Two sevenths of the Airlines account funds will be distributed to the United States Treasury. Two sevenths of the Airlines account funds will be distributed to the Refiner-Litigants Escrow Account. Two sevenths of the Airlines account funds will be distributed to the States in the proportions listed in Exhibit L of the Agreement.

    One seventh of the Airlines account funds will be allocated to the End-Users account, which will be distributed in the same proportions as the residual Subpart V funds were distributed pursuant to our notice in 72 FR 46461, 46462 (August 14, 2007). The funds will be split equally, with half distributed to the United States Treasury and half distributed to the States. The funds distributed to the States will be divided in the proportions used for the final distribution of the Subpart V funds, which are identical to those listed in Exhibit L of the Agreement. All funds distributed to the States are subject to the same restricted uses as those received by that State as a result of the settlement of the case known as In Re: Stripper Well Litigation, M.D.L. No. 378. A list of distribution percentages is included as an appendix to this Notice. If a State does not submit the Required Information described below by the specified deadline, the funds will be considered unclaimed and will be transferred to the U.S. Treasury.

    C. Required Information

    In order to receive its allotted funds, each Recipient, including State Recipients, must submit the following no later than January 16, 2019.

    Statement of Intent: The Statement should be brief and include the Recipient's name and the representative's authority to claim the Recipient's funds.

    Information Required by the Agreement: The Agreement requires that certain Releases of Claims be executed and submitted to DOE before Recipients may receive distributions.

    ○ If a Recipient has not ever submitted the relevant Release of Claims, it should contact DOE at the below address to obtain a copy of the release, and should submit the executed release with the other required information described in this section.

    ○ If a Recipient has previously submitted the relevant Release of Claims, it should submit to DOE a notarized statement certifying that it has submitted the release. The notarized statement should be submitted with the other required information described in this section.

    Electronic Funds Transfer (EFT) Information: Each Recipient must submit all information necessary for DOE to make an electronic distribution of funds, including the name and contact information (phone number, email address, and mailing address) of a person designated to be the Point of Contact, banking information, and Tax ID number. DOE will not contact Recipients regarding problems, discrepancies, or other issues with EFT information. DOE will notify the designated Point of Contact when the EFT is initiated. If an EFT is unsuccessful and the Recipient does not contact DOE to correct the error by the 14th day following the EFT initiation, the amount not distributed will be considered unclaimed and will be transferred to the United States Treasury.

    Submissions should in PDF format and must be submitted by email to [email protected] The subject line should include “Citronelle Settlement Agreement Recipient Documents” and the name of the State or other Recipient. The Releases of Claims contained in the Agreement's Exhibits may be obtained by contacting Kristin L. Martin, Attorney-Advisor, Office of Hearings and Appeals, by email at [email protected], or by telephone at 202-287-1550.

    Appendix A—Proposed Distribution Percentages and List of Refiner-Litigants A. Citronelle Airline Account Funds Refiner-Litigants 28.57142857142860000%

    • Each Refiner-Litigant Entity is entitled to 0.865800865800867% of the total Airline Account Funds.

    United States Treasury 35.71428571428570000% Alabama 0.54804016064259400% Alaska 0.13818786523157600% American Samoa 0.00636083244822057% Arizona 0.36634454245826900% Arkansas 0.45449277491405100% California 3.26944016176838000% Colorado 0.38401187480512000% Connecticut 0.60652108584973400% Delaware 0.16956338168467300% District of Columbia 0.08531354824083700% Florida 1.65010975432690000% Georgia 0.79531816470797200% Guam 0.05263184468083650% Hawaii 0.24538846523323400% Idaho 0.14657787754978300% Illinois 1.64040323767528000% Indiana 0.87972416423889800% Iowa 0.46535022190036900% Kansas 0.40036549196707900% Kentucky 0.45780595111052400% Louisiana 0.84950225360465700% Maine 0.26254694847105300% Maryland 0.63946084248035600% Massachusetts 1.22259929840854000% Michigan 1.21688372104464000% Minnesota 0.61974582045967800% Mississippi 0.48769574322855100% Missouri 0.70516872255815100% Montana 0.16165040119813900% Nebraska 0.26336705431455200% Nevada 0.14466342873599700% New Hampshire 0.16645300019308600% New Jersey 1.31838653652643000% New Mexico 0.23395138247190300% New York 2.76553651908726000% No. Mariana Islands 0.00329014604847478% North Carolina 0.80159665169915200% North Dakota 0.13090382462201500% Ohio 1.34202999992372000% Oklahoma 0.44109500817469100% Oregon 0.35401620870755400% Pennsylvania 1.66287802161090000% Puerto Rico 0.34023415151078600% Rhode Island 0.14160268359603600% South Carolina 0.42578568669101500% South Dakota 0.12770074547322300% Tennessee 0.57787034891897200% Texas 2.63486674686911000% Utah 0.21069728945457100% Vermont 0.08547809926032230% Virgin Islands 0.16520939843142600% Virginia 0.91659346391607800% Washington 0.54540262288818800% West Virginia 0.21344547509163300% Wisconsin 0.62838735451951800% Wyoming 0.14563871266099600% Total 35.71428571428570000% B. Non-Litigant Refiners Account Funds Refiner-Litigants 100%

    • Each Refiner-Litigant Entity is entitled to 3.03% of the Non-Litigant Refiners Account Funds.

    C. List of Refiner-Litigants Amoco Oil Company Ashland Oil, Inc. Atlantic Richfield Company Axel Johnson, Inc. BHP Petroleum Americas Refining, Inc. Castle Oil Corporation Charter International Oil Company Charter Oil Company Chevron U.S.A., Inc. Clark Oil & Refining Corporation The Coastal Corporation Commonwealth Oil Refining Company Conoco Inc. Crown Central Petroleum corp. Diamond Shamrock Refining & Marketing Company Exxon Corporation Fina Oil and Chemical Company Gulf States Oil & Refining Co. Kerr-McGee Refining Corporation La Gloria Oil and Gas Company Marathon Oil Company Mobil Oil Corporation New England Petroleum Corporation Oxy USA Inc. Shell Oil Company Sprague Energy Corporation Tesoro Petroleum Corporation Texaco Inc. Texaco Refining & Marketing Inc. Tosco Corporation Total Petroleum Inc. Union Pacific Resources Company Wyatt Energy Inc. Signed in Washington, DC on: October 12, 2018. Poli A. Marmolejos, <E T="03">Director, Office of Hearings and Appeals.</E>
    [FR Doc. 2018-22705 Filed 10-17-18; 8:45 am] BILLING CODE 6450-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. ER19-70-000] Keystone Power Pass-Through Holders LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding of Keystone Power Pass-Through Holders LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.

    Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.

    Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is October 30, 2018.

    The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet access who will eFile a document and/or be listed as a contact for an intervenor must create and validate an eRegistration account using the eRegistration link. Select the eFiling link to log on and submit the intervention or protests.

    Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426.

    The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the website that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email [email protected] or call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: October 10, 2018. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2018-22711 Filed 10-17-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 3023-014] Blackstone Hydro, Inc.; Notice of Application Tendered for Filing With the Commission and Soliciting Additional Study Requests and Establishing Procedural Schedule for Relicensing and a Deadline for Submission of Final Amendments

    Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection.

    a. Type of Application: New Major License.

    b. Project No.: P-3023-014.

    c. Date filed: October 1, 2018.

    d. Applicant: Blackstone Hydro, Inc.

    e. Name of Project: Tupperware Hydroelectric Project.

    f. Location: On the Blackstone River in Providence County, Rhode Island and Worcester County, Massachusetts. No federal lands are occupied by the project works or located within the project boundary.

    g. Filed Pursuant to: Federal Power Act 16 U.S.C. 791(a)-825(r).

    h. Applicant Contact: Lewis C. Loon, General Manager, Operations and Maintenance—USA/QC, KEI USA Power Management Inc., 423 Brunswick Avenue, Gardiner, ME 04345; Phone at (207) 203-3027, or email at [email protected].

    i. FERC Contact: Amy Chang at (202) 502-8250, or [email protected].

    j. Cooperating agencies: Federal, state, local, and tribal agencies with jurisdiction and/or special expertise with respect to environmental issues that wish to cooperate in the preparation of the environmental document should follow the instructions for filing such requests described in item l below. Cooperating agencies should note the Commission's policy that agencies that cooperate in the preparation of the environmental document cannot also intervene. See, 94 FERC 61,076 (2001).

    k. Pursuant to section 4.32(b)(7) of 18 CFR of the Commission's regulations, if any resource agency, Indian Tribe, or person believes that an additional scientific study should be conducted in order to form an adequate factual basis for a complete analysis of the application on its merit, the resource agency, Indian Tribe, or person must file a request for a study with the Commission not later than 60 days from the date of filing of the application, and serve a copy of the request on the applicant.

    l. Deadline for filing additional study requests and requests for cooperating agency status: November 30, 2018.

    The Commission strongly encourages electronic filing. Please file additional study requests and requests for cooperating agency status using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. For assistance, please contact FERC Online Support at [email protected], (866) 208-3676 (toll free), or (202) 502-8659 (TTY). In lieu of electronic filing, please send a paper copy to: Secretary, Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426. The first page of any filing should include docket number P-3023-014.

    m. The application is not ready for environmental analysis at this time.

    n. Project Description: The existing Tupperware Hydroelectric Project consists of: (1) A 210-foot-long, 12-foot-high arch-type masonry dam and spillway (Tupperware Dam) with 12-inch-high flashboards and a crest elevation of 192.8 feet above mean sea level (msl) at the top of the flashboards; (2) an approximately 2-mile-long impoundment with a normal maximum elevation of 192.8 feet msl; (3) water conveyance structures that consist of: (a) An 1,100-foot-long, 60- to 100-foot-wide power canal located 700 feet upstream of the Tupperware Dam; (b) an 11.5-acre headpond at a normal maximum elevation of 192.8 feet msl; (c) a 300-foot-long, 40-foot-wide headrace canal structure; (d) a 46-foot-long, 16-foot-high headgate dam structure with four 7-foot-high, 8-foot-wide intake gates; and (e) four 8-foot-diameter, 22-foot-long buried penstocks; (4) a concrete and brick powerhouse containing four vertical Francis turbine-generator units with a total authorized capacity of 1,724 kilowatts; (5) a 100-foot-long, 40-foot-wide tailrace channel that discharges into the Blackstone River; (6) outlet work structures located upstream of the headgate dam structure in the headrace canal that consist of: (a) A 37-foot-long, 12-foot-high emergency spillway with a crest elevation of 196 feet msl located at the north end of the headrace; (b) two 5-foot-wide, 5-foot-high outlet gates; (c) a 60-foot-long outlet channel; and (d) two 36-inch-diameter, 150-foot-long concrete conduits that empty into a 190-foot-long, 20-foot-wide channel that discharges into the Blackstone River downstream from the tailrace channel; (7) a 90-foot-long, 4.16-kilovolt (kV) transmission line, a 3,000 kV-amperes step-up transformer, and a 1,300-foot-long, 13.8-kV transmission line connecting the project generators to the regional electric grid; and (8) appurtenant facilities.

    The project bypasses approximately 1 mile of the Blackstone River, and there is currently no required minimum instream flow for the bypassed reach. Blackstone Hydro operates the project in a run-of-river (ROR) mode with an annual average generation of approximately 4,027 megawatt-hours.

    Blackstone Hydro proposes to: (1) continue operating the project in a ROR mode; (2) provide a year-round minimum flow of 35 cubic feet per second into the bypassed reach; (3) provide upstream eel passage at the project, following installation of an upstream eel passage facility at the downstream Woonsocket Falls Project No. 2972; (4) implement nighttime turbine shutdowns to facilitate downstream eel passage; and (5) develop procedures for operating the outlet gates to address water quality in the power canal.

    o. A copy of the application is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's website at http://www.ferc.gov using the “eLibrary” link. Enter the docket number excluding the last three digits in the docket number field to access the document. For assistance, contact FERC Online Support. A copy is also available for inspection and reproduction at the address in item h above.

    You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances related to this or other pending projects. For assistance, contact FERC Online Support.

    p. Procedural schedule and final amendments: The application will be processed according to the following preliminary schedule. Revisions to the schedule will be made as appropriate.

    Issue Deficiency Letter (if necessary) December 2018. Request Additional Information December 2018. Issue Acceptance Letter March 2019. Issue Scoping Document 1 for comments April 2019. Request Additional Information (if necessary) June 2019. Issue Scoping Document 2 July 2019. Issue Notice of Ready for Environmental Analysis July 2019. Commission issues Environmental Assessment January 2020.

    q. Final amendments to the application must be filed with the Commission no later than 30 days from the issuance date of the notice of ready for environmental analysis.

    Dated: October 12, 2018. Kimberly D. Bose, Secretary.
    [FR Doc. 2018-22728 Filed 10-17-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. ER19-92-000] GRP Madison, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding of GRP Madison, LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.

    Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.

    Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is November 1, 2018.

    The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet access who will eFile a document and/or be listed as a contact for an intervenor must create and validate an eRegistration account using the eRegistration link. Select the eFiling link to log on and submit the intervention or protests.

    Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426.

    The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the website that enables subscribers

    to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email [email protected] or call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: October 12, 2018. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2018-22717 Filed 10-17-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Combined Notice of Filings #1

    Take notice that the Commission received the following electric corporate filings:

    Docket Numbers: EC19-9-000.

    Applicants: GE Capital Global Holdings, LLC, Arlington Valley Solar Energy II, LLC, CPV Fairview, LLC, Russell City Energy Company, LLC, Caledonia Generating, LLC, Apollo Global Management, LLC.

    Description: Joint Application for Authorization Under Section 203 of the Federal Power Act, et al. of Arlington Valley Solar Energy II, LLC, et al.

    Filed Date: 10/11/18.

    Accession Number: 20181011-5154.

    Comments Due: 5 p.m. ET 11/1/18.

    Docket Numbers: EC19-10-000.

    Applicants: Clean Energy Future—Lordstown, LLC, Perennial Lordstown, LLC.

    Description: Joint Application for Authorization Under Section 203 of the Federal Power Act, et al. of Clean Energy Future—Lordstown, LLC, et al.

    Filed Date: 10/11/18.

    Accession Number: 20181011-5165.

    Comments Due: 5 p.m. ET 11/1/18.

    Take notice that the Commission received the following electric rate filings:

    Docket Numbers: ER13-821-012: ER12-281-011; ER10-1529-005.

    Applicants: Scrubgrass Generating Company, L.P. Northampton Generating Company, L.P., Northern Iowa Windpower, LLC.

    Description: Notice of Change in Status of Scrubgrass Generating Company, L.P., et al.

    Filed Date: 10/10/18.

    Accession Number: 20181010-5165.

    Comments Due: 5 p.m. ET 10/31/18.

    Docket Numbers: ER14-152-009; ER13-1143-006; ER13-1144-006; ER10-2196-005; ER17-1849-002; ER10-2740-013; ER15-1657-007; ER10-2742-012.

    Applicants: Elgin Energy Center, LLC, Essential Power OPP, LLC, Essential Power Rock Springs, LLC, Lakewood Cogeneration, L.P., Nautilus Power, LLC, Rocky Road Power, LLC, SEPG Energy Marketing Services, LLC, Tilton Energy LLC.

    Description: Notice of Non-Material Change in Status of Elgin Energy Center, LLC, et al.

    Filed Date: 10/11/18.

    Accession Number: 20181011-5177.

    Comments Due: 5 p.m. ET 11/1/18.

    Docket Numbers: ER18-2272-001.

    Applicants: Midcontinent Independent System Operator, Inc.

    Description: Tariff Amendment: 2018-10-12_SA 3144 ETI-Liberty County-ETI MPFCA (J472 J483) Sub Original to be effective 8/7/2018.

    Filed Date: 10/12/18.

    Accession Number: 20181012-5022.

    Comments Due: 5 p.m. ET 11/2/18.

    Docket Numbers: ER18-2336-001.

    Applicants: Midcontinent Independent System Operator, Inc.

    Description: Tariff Amendment: 2018-10-12_SA 3150 CMS Energy Resource-METC GIA (J571) Substitute Original to be effective 8/15/2018.

    Filed Date: 10/12/18.

    Accession Number: 20181012-5026.

    Comments Due: 5 p.m. ET 11/2/18.

    Docket Numbers: ER19-89-000.

    Applicants: North Rosamond Solar, LLC.

    Description: Baseline eTariff Filing: Market-Based Rate Authorization and Request for Waivers and Blanket Approvals to be effective 10/12/2018.

    Filed Date: 10/11/18.

    Accession Number: 20181011-5146.

    Comments Due: 5 p.m. ET 11/1/18.

    Docket Numbers: ER19-90-000.

    Applicants: Clean Energy Future—Lordstown, LLC.

    Description: Baseline eTariff Filing: Reactive Power Tariff Application to be effective 12/1/2018.

    Filed Date: 10/11/18.

    Accession Number: 20181011-5150.

    Comments Due: 5 p.m. ET 11/1/18.

    Docket Numbers: ER19-91-000.

    Applicants: GRP Franklin, LLC.

    Description: Baseline eTariff Filing: Application for Market Based Rate to be effective 12/8/2018.

    Filed Date: 10/10/18.

    Accession Number: 20181010-5163.

    Comments Due: 5 p.m. ET 10/31/18.

    Docket Numbers: ER19-92-000.

    Applicants: GRP Madison, LLC.

    Description: Baseline eTariff Filing: Market Based Rate Application to be effective 12/8/2018.

    Filed Date: 10/10/18.

    Accession Number: 20181010-5164.

    Comments Due: 5 p.m. ET 10/31/18.

    Docket Numbers: ER19-93-000.

    Applicants: Midcontinent Independent System Operator, Inc.

    Description: § 205(d) Rate Filing: 2018-10-12_SA 3175 Deltas Edge—EMI GIA (J679) to be effective 9/27/2018.

    Filed Date: 10/12/18.

    Accession Number: 20181012-5028.

    Comments Due: 5 p.m. ET 11/2/18.

    Docket Numbers: ER19-94-000.

    Applicants: Clear River Energy LLC, Invenergy Energy Management LLC.

    Description: Request for Limited Waiver, et al. of Clear River Energy LLC, et al.

    Filed Date: 10/11/18.

    Accession Number: 20181011-5176.

    Comments Due: 5 p.m. ET 10/25/18.

    Docket Numbers: ER19-95-000.

    Applicants: North Rosamond Solar, LLC.

    Description: § 205(d) Rate Filing: Filing of Shared Facilities Common Ownership Agreement (Rattlesnake substation) to be effective 10/14/2018.

    Filed Date: 10/12/18.

    Accession Number: 20181012-5053.

    Comments Due: 5 p.m. ET 11/2/18.

    Docket Numbers: ER19-96-000.

    Applicants: North Rosamond Solar, LLC.

    Description: § 205(d) Rate Filing: Certificates of Concurrence for Shared Facilities Agreements to be effective 10/14/2018.

    Filed Date: 10/12/18.

    Accession Number: 20181012-5054.

    Comments Due: 5 p.m. ET 11/2/18.

    Docket Numbers: ER19-97-000.

    Applicants: Southwest Power Pool, Inc.

    Description: Reliability Penalty Cost Recovery, et al. of Southwest Power Pool, Inc.

    Filed Date: 10/11/18.

    Accession Number: 20181011-5178.

    Comments Due: 5 p.m. ET 11/1/18.

    The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.

    Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.

    eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: October 12, 2018. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2018-22713 Filed 10-17-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. ER19-66-000] Conemaugh Power Pass-Through Holders LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding of Conemaugh Power Pass-Through Holders LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.

    Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.

    Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is October 30, 2018.

    The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet access who will eFile a document and/or be listed as a contact for an intervenor must create and validate an eRegistration account using the eRegistration link. Select the eFiling link to log on and submit the intervention or protests.

    Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426.

    The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the website that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email [email protected] or call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: October 10, 2018. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2018-22710 Filed 10-17-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. ER19-89-000] North Rosamond Solar, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding of North Rosamond Solar, LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.

    Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.

    Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is November 1, 2018.

    The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet access who will eFile a document and/or be listed as a contact for an intervenor must create and validate an eRegistration account using the eRegistration link. Select the eFiling link to log on and submit the intervention or protests.

    Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426.

    The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the website that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email [email protected] or call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: October 12, 2018. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2018-22715 Filed 10-17-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket Nos. CP16-454-000] Rio Grande LNG, LLC, Rio Bravo Pipeline Company, LLC; Notice of Availability of the Draft Environmental Impact Statement for the Proposed Rio Grande LNG Project

    The staff of the Federal Energy Regulatory Commission (FERC or Commission) has prepared a draft environmental impact statement (EIS) for the Rio Grande LNG Project (Project) proposed by Rio Grande LNG, LLC (RG LNG) and Rio Bravo Pipeline Company, LLC (RB Pipeline) (collectively referred to as the RG Developers) in the above-referenced dockets. RG LNG requests authorization pursuant to section 3(a) of the Natural Gas Act (NGA) to construct and operate liquefied natural gas (LNG) export facilities in Cameron County, Texas, and RB Pipeline requests a Certificate of Public Convenience and Necessity pursuant to section 7(c) of the NGA to construct, operate, and maintain a new pipeline system in Jim Wells, Kleberg, Kenedy, Willacy, and Cameron Counties, Texas.

    The draft EIS assesses the potential environmental effects of the construction and operation of the Project in accordance with the requirements of the National Environmental Policy Act (NEPA). The FERC staff concludes that construction and operation of the Rio Grande LNG Project would result in some adverse environmental impacts, but these impacts would be reduced to less than significant levels. However, the Rio Grande LNG Project, combined with other projects within the geographic scope, would result in certain significant cumulative impacts.

    The U.S. Army Corps of Engineers, U.S. Coast Guard, U.S. Department of Energy, U.S. Department of Transportation's Pipeline and Hazardous Materials Safety Administration, the DOT's Federal Aviation Administration, the U.S. Fish and Wildlife Service, the National Park Service, the U.S. Environmental Protection Agency, and the National Oceanic and Atmospheric Administration—National Marine Fisheries Service participated as cooperating agencies in the preparation of the EIS. Cooperating agencies have jurisdiction by law or special expertise with respect to resources potentially affected by the proposal and participate in the NEPA analysis. Although the cooperating agencies provided input to the conclusions and recommendations presented in the draft EIS, the agencies will present their own conclusions and recommendations in their respective Records of Decision for the Project.

    The draft EIS addresses the potential environmental effects of the construction and operation of the following proposed facilities:

    • Six liquefaction trains at the Rio Grande LNG Terminal, each with a nominal capacity of 4.5 million tons per annum of LNG for export, resulting in the total nominal capacity of 27.0 million tons per annum;

    • four LNG storage tanks, each with a net capacity of 180,000 cubic meters;

    • LNG truck loading facilities with four loading bays, each with the capacity to load 12 to 15 trucks per day;

    • a refrigerant storage area and truck unloading facilities;

    • a condensate storage area and truck loading facilities;

    • a new marine slip with two LNG vessel berths to accommodate simultaneous loading of two LNG vessels, an LNG vessel and support vessel maneuvering area, and an LNG transfer system;

    • a materials off-loading facility;

    • 2.4 miles of 42-inch-diameter pipeline, including 0.8 mile of dual pipeline, to gather gas from existing systems in Kleberg and Jim Wells Counties (referred to as the Header System);

    • 135.5 miles of parallel 42-inch-diameter pipelines originating in Kleberg County and terminating at the Rio Grande LNG Terminal in Cameron County (referred to as Pipelines 1 and 2);

    • four stand-alone metering sites along the Header System;

    • two new interconnect booster compressor stations, each with a metering site;

    • three new compressor stations (one at the LNG Terminal site); and

    • other associated utilities, systems, and facilities (yards, access roads, etc.).

    The Commission mailed a copy of the Notice of Availability to federal, state, and local government representatives and agencies; elected officials; environmental and public interest groups; Native American tribes; potentially affected landowners and other interested individuals and groups; and newspapers and libraries in the project area. The draft EIS is only available in electronic format. It may be viewed and downloaded from the FERC's website (www.ferc.gov), on the Environmental Documents page (https://www.ferc.gov/industries/gas/enviro/eis.asp). In addition, the draft EIS may be accessed by using the eLibrary link on the FERC's website. Click on the eLibrary link (https://www.ferc.gov/docs-filing/elibrary.asp), click on General Search, and enter the docket number in the Docket Number field, excluding the last three digits (i.e. CP16-454 or CP16-455). Be sure you have selected an appropriate date range. For assistance, please contact FERC Online Support at [email protected] or toll free at (866) 208-3676, or for TTY, contact (202) 502-8659.

    Any person wishing to comment on the draft EIS may do so. Your comments should focus on draft EIS's disclosure and discussion of potential environmental effects, reasonable alternatives, and measures to avoid or lessen environmental impacts. To ensure consideration of your comments on the proposal in the final EIS, it is important that the Commission receive your comments on or before 5:00 p.m. Eastern Time on December 3, 2018.

    For your convenience, there are four methods you can use to submit your comments to the Commission. The Commission will provide equal consideration to all comments received, whether filed in written form or provided verbally. The Commission encourages electronic filing of comments and has staff available to assist you at (866) 208-3676 or [email protected]. Please carefully follow these instructions so that your comments are properly recorded.

    (1) You can file your comments electronically using the eComment feature on the Commission's website (www.ferc.gov) under the link to Documents and Filings. This is an easy method for submitting brief, text-only comments on a project;

    (2) You can file your comments electronically by using the eFiling feature on the Commission's website (www.ferc.gov) under the link to Documents and Filings. With eFiling, you can provide comments in a variety of formats by attaching them as a file with your submission. New eFiling users must first create an account by clicking on eRegister. If you are filing a comment on a particular project, please select “Comment on a Filing” as the filing type; or

    (3) You can file a paper copy of your comments by mailing them to the following address. Be sure to reference the Project docket numbers (CP16-454-000, CP16-455-000) with your submission: Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888 First Street NE, Room 1A, Washington, DC 20426

    (4) In lieu of sending written or electronic comments, the Commission invites you to attend one of the public comment sessions its staff will conduct in the Project area to receive comments on the draft EIS, scheduled as follows:

    Date and time Location Tuesday, November 13, 2018: 5:00-8:00 p.m. local time Texas A&M, 700 University Blvd., Kingsville, TX 78363, 361-593-4173. Wednesday, November 14, 2018: 5:00-8:00 p.m. local time La Quinta, 128 N Expressway 77, Raymondville, TX 78750, 956-689-4000. Thursday, November 15, 2018: 5:00-9:00 p.m. local time Port Isabel Convention Center, 309 E. Railroad Ave., Port Isabel, TX 78578, 956-433-7195.

    The primary goal of these comment sessions is to have you identify the specific environmental issues and concerns with the draft EIS. Individual verbal comments will be taken on a one-on-one basis with a court reporter. This format is designed to receive the maximum amount of verbal comments in a convenient way during the timeframe allotted.

    The Kingsville and Raymondville scoping sessions are scheduled from 5:00 p.m. to 8:00 p.m. local time, and the Port Isabel scoping session is scheduled from 5:00 p.m. to 9:00 p.m. local time. You may arrive at any time after 5:00 p.m. There will not be a formal presentation by Commission staff when the session opens. If you wish to speak, the Commission staff will hand out numbers in the order of your arrival. Comments will be taken until the closing hour for all scoping sessions. However, if no additional numbers have been handed out and all individuals who wish to provide comments have had an opportunity to do so, staff may conclude the session 30 minutes before the closing hour. Please see appendix 1 for additional information on the session format and conduct.1

    1 The appendices referenced in this notice will not appear in the Federal Register. Copies of the appendices were sent to all those receiving this notice in the mail and are available at www.ferc.gov using the link called eLibrary or from the Commission's Public Reference Room, 888 First Street NE, Washington, DC 20426, or call (202) 502-8371. For instructions on connecting to eLibrary, refer to the last page of this notice.

    Your verbal comments will be recorded by the court reporter (with FERC staff or representative present) and become part of the public record for this proceeding. Transcripts will be publicly available on FERC's eLibrary system (see below for instructions on using eLibrary). If a significant number of people are interested in providing verbal comments in the one-on-one settings, a time limit of 5 minutes may be implemented for each commentor.

    It is important to note that verbal comments hold the same weight as written or electronically submitted comments. Although there will not be a formal presentation, Commission staff will be available throughout the comment session to answer your questions about the environmental review process.

    Any person seeking to become a party to the proceeding must file a motion to intervene pursuant to Rule 214 of the Commission's Rules of Practice and Procedures (18 CFR part 385.214). Motions to intervene are more fully described at http://www.ferc.gov/resources/guides/how-to/intervene.asp. Only intervenors have the right to seek rehearing or judicial review of the Commission's decision. The Commission grants affected landowners and others with environmental concerns intervenor status upon showing good cause by stating that they have a clear and direct interest in this proceeding that no other party can adequately represent. Simply filing environmental comments will not give you intervenor status, but you do not need intervenor status to have your comments considered.

    Questions?

    Additional information about the Projects is available from the Commission's Office of External Affairs, at (866) 208-FERC, or on the FERC website (www.ferc.gov) using the eLibrary link. The eLibrary link also provides access to the texts of all formal documents issued by the Commission, such as orders, notices, and rulemakings.

    In addition, the Commission offers a free service called eSubscription that allows you to keep track of all formal issuances and submittals in specific dockets. This can reduce the amount of time you spend researching proceedings by automatically providing you with notification of these filings, document summaries, and direct links to the documents. Go to www.ferc.gov/docs-filing/esubscription.asp.

    Dated: October 12, 2018. Kimberly D. Bose, Secretary.
    [FR Doc. 2018-22727 Filed 10-17-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. ER19-91-000] GRP Franklin, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding of GRP Franklin, LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.

    Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.

    Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is November 1, 2018.

    The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet access who will eFile a document and/or be listed as a contact for an intervenor must create and validate an eRegistration account using the eRegistration link. Select the eFiling link to log on and submit the intervention or protests.

    Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426.

    The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the website that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email [email protected] or call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: October 12, 2018. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2018-22716 Filed 10-17-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Combined Notice of Filings

    Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:

    Filings Instituting Proceedings

    Docket Number: PR18-84-000.

    Applicants: Comanche Trail Pipeline, LLC.

    Description: Tariff filing per 284.123(b), (e) + (g): Comanche Trail Pipeline, LLC Statement of Operating Conditions, October 1, 2018 to be effective 10/1/2018.

    Filed Date: 9/28/18.

    Accession Number: 201809285065.

    Comments Due: 5 p.m. ET 10/19/18.

    284.123(g) Protests Due: 5 p.m. ET 11/27/18.

    Docket Number: PR18-85-000.

    Applicants: Trans-Pecos Pipeline, LLC.

    Description: Tariff filing per 284.123(b), (e) + (g): Trans-Pecos Pipeline, LLC Statement of Operating Conditions, October 1, 2018 to be effective 10/1/2018.

    Filed Date: 9/28/18.

    Accession Number: 201809285066.

    Comments Due: 5 p.m. ET 10/19/18.

    284.123(g) Protests Due: 5 p.m. ET 11/27/18.

    Docket Number: PR18-86-000.

    Applicants: Energy Transfer Fuel, LP.

    Description: Tariff filing per 284.123(b), (e) + (g): Energy Transfer Fuel, LP Statement of Operating Conditions, October 1, 2018 to be effective 10/1/2018.

    Filed Date: 9/28/18.

    Accession Number: 201809285072.

    Comments Due: 5 p.m. ET 10/19/18.

    284.123(g) Protests Due: 5 p.m. ET 11/27/18.

    Docket Number: PR18-87-000.

    Applicants: ONEOK Field Services Company, L.L.C.

    Description: Tariff filing per 284.123(b)(2) + (g): OFS 311 Cost of Service Rate Filing to be effective 9/28/2018.

    Filed Date: 9/28/18.

    Accession Number: 201809285081.

    Comments Due: 5 p.m. ET 10/19/18.

    284.123(g) Protests Due: 5 p.m. ET 11/27/18.

    Docket Number: PR18-88-000.

    Applicants: Houston Pipe Line Company LP.

    Description: Tariff filing per 284.123(b), (e) + (g): Houston Pipe Line Company, LP Statement of Operating Conditions, October 1, 2018 to be effective 10/1/2018.

    Filed Date: 9/28/18.

    Accession Number: 201809285082.

    Comments Due: 5 p.m. ET 10/19/18.

    284.123(g) Protests Due: 5 p.m. ET 11/27/18.

    Docket Number: PR18-89-000.

    Applicants: Red Bluff Express Pipeline, LLC.

    Description: Tariff filing per 284.123(b), (e) + (g): Red Bluff Express Pipeline, LLC Statement of Operating Conditions, 10/1/2018 to be effective 10/1/2018.

    Filed Date: 9/28/18.

    Accession Number: 201809285085.

    Comments Due: 5 p.m. ET 10/19/18.

    284.123(g) Protests Due: 5 p.m. ET 11/27/18.

    Docket Number: PR18-90-000.

    Applicants: Regency Intrastate Gas LP.

    Description: Tariff filing per 284.123(b), (e) + (g): Regency Intrastate Gas LP Statement of Operating Conditions, October 1, 2018 to be effective 10/1/2018.

    Filed Date: 9/28/18.

    Accession Number: 201809285088.

    Comments Due: 5 p.m. ET 10/19/18.

    284.123(g) Protests Due: 5 p.m. ET 11/27/18.

    Docket Numbers: RP18-1257-001.

    Applicants: National Fuel Gas Supply Corporation.

    Description: Compliance filing GT&C Section 42 Tracker Filing—Amendment to be effective 11/1/2018.

    Filed Date: 10/4/18.

    Accession Number: 20181004-5184.

    Comments Due: 5 p.m. ET 10/16/18.

    The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.

    Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.

    eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: October 10, 2018. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2018-22712 Filed 10-17-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Combined Notice of Filings #1

    Take notice that the Commission received the following electric corporate filings:

    Docket Numbers: EC19-6-000.

    Applicants: NRG REMA LLC, Keystone Power Pass-Through Holders LLC, Conemaugh Power Pass-Through Holders LLC.

    Description: Joint Application for Authorization Under Section 203 of the Federal Power Act, et al. of NRG REMA LLC, et al.

    Filed Date: 10/9/18.

    Accession Number: 20181009-5298.

    Comments Due: 5 p.m. ET 10/30/18.

    Docket Numbers: EC19-7-000.

    Applicants: MidAmerican Wind Tax Equity Holdings, LLC, Blue Cloud Wind Energy, LLC, Blue Cloud TE Partnership LLC, Sponsor Blue Cloud HoldCo LLC.

    Description: Joint Application for Authorization Under Section 203 of the Federal Power Act, et al. of Blue Cloud Wind Energy, LLC, et al.

    Filed Date: 10/9/18.

    Accession Number: 20181009-5324.

    Comments Due: 5 p.m. ET 10/30/18.

    Take notice that the Commission received the following exempt wholesale generator filings:

    Docket Numbers: EG19-6-000.

    Applicants: Conemaugh Power Pass-Through Holders LLC.

    Description: Notice of Self-Certification of Conemaugh Power Pass-Through Holders LLC.

    Filed Date: 10/10/18.

    Accession Number: 20181010-5070.

    Comments Due: 5 p.m. ET 10/31/18.

    Docket Numbers: EG19-7-000.

    Applicants: Keystone Power Pass-Through Holders LLC.

    Description: Notice of Self-Certification of Keystone Power Pass-Through Holders LLC.

    Filed Date: 10/10/18.

    Accession Number: 20181010-5071.

    Comments Due: 5 p.m. ET 10/31/18.

    Docket Numbers: EG19-8-000.

    Applicants: GRP Madison, LLC.

    Description: Notice of Self-Certification of Exempt Wholesale Generator Status of GRP Madison, LLC.

    Filed Date: 10/10/18.

    Accession Number: 20181010-5084.

    Comments Due: 5 p.m. ET 10/31/18.

    Docket Numbers: EG19-9-000.

    Applicants: GRP Franklin, LLC.

    Description: Notice of Self-Certification of Exempt Wholesale Generator Status of GRP Franklin, LLC.

    Filed Date: 10/10/18.

    Accession Number: 20181010-5085.

    Comments Due: 5 p.m. ET 10/31/18.

    Take notice that the Commission received the following electric rate filings:

    Docket Numbers: ER10-2527-007; ER10-1821 018; ER10-2400 010; ER10-2528 003; ER10-2529 003; ER10-2530 004; ER10-2531 008; ER10-2532 013; ER10-2533 007; ER10-2534 004; ER10-2535 008; ER11-4475 011.

    Applicants: Allegheny Ridge Wind Farm, LLC, Crescent Ridge LLC, GSG, LLC, Mendota Hills, LLC, Cedar Creek Wind Energy, LLC, Goshen Phase II LLC, Rockland Wind Farm LLC, Aragonne Wind LLC, Buena Vista Energy, LLC, Kumeyaay Wind LLC, Blue Canyon Windpower LLC, Caprock Wind LLC.

    Description: Notice of Non-Material Change in Status of Allegheny Ridge Wind Farm, LLC, et al.

    Filed Date: 10/9/18.

    Accession Number: 20181009-5326.

    Comments Due: 5 p.m. ET 10/30/18.

    Docket Numbers: ER17-1442-002.

    Applicants: Axiall, LLC.

    Description: Supplement to June 28, 2018 Updated Market Power Analysis for Central Region of Axiall, LLC.

    Filed Date: 10/9/18.

    Accession Number: 20181009-5318.

    Comments Due: 5 p.m. ET 10/30/18.

    Docket Numbers: ER19-69-000.

    Applicants: Rockland Wind Farm LLC.

    Description: § 205(d) Rate Filing: Notice of Change in Category Seller Status to be effective 10/10/2018.

    Filed Date: 10/9/18.

    Accession Number: 20181009-5235.

    Comments Due: 5 p.m. ET 10/30/18.

    Docket Numbers: ER19-70-000.

    Applicants: Keystone Power Pass-Through Holders LLC.

    Description: Baseline eTariff Filing: Market-Based Rate Tariff Application to be effective 10/9/2018.

    Filed Date: 10/9/18.

    Accession Number: 20181009-5236.

    Comments Due: 5 p.m. ET 10/30/18.

    Docket Numbers: ER19-71-000.

    Applicants: Midcontinent Independent System Operator, Inc.

    Description: § 205(d) Rate Filing: 2018-10-09_SA 3170 Crossett Solar—EAI GIA (J680) to be effective 9/24/2018.

    Filed Date: 10/9/18.

    Accession Number: 20181009-5243.

    Comments Due: 5 p.m. ET 10/30/18.

    Docket Numbers: ER19-72-000.

    Applicants: Bruce Power Inc.

    Description: § 205(d) Rate Filing: Notice of Non-Material Change in Status and Change in Category Seller Status to be effective 10/10/2018.

    Filed Date: 10/9/18.

    Accession Number: 20181009-5255.

    Comments Due: 5 p.m. ET 10/30/18.

    Docket Numbers: ER19-73-000.

    Applicants: Conemaugh Power Pass-Through Holders LLC.

    Description: Initial rate filing: Reactive Rate Filing to be effective 12/31/9998.

    Filed Date: 10/9/18.

    Accession Number: 20181009-5260.

    Comments Due: 5 p.m. ET 10/30/18.

    Docket Numbers: ER19-74-000.

    Applicants: Keystone Power Pass-Through Holders LLC.

    Description: Initial rate filing: Reactive Rate Filing to be effective 12/31/9998.

    Filed Date: 10/9/18.

    Accession Number: 20181009-5266.

    Comments Due: 5 p.m. ET 10/30/18.

    Docket Numbers: ER19-75-000.

    Applicants: Portsmouth Genco, LLC.

    Description: § 205(d) Rate Filing: Request for Category 1 Status to be effective 10/10/2018.

    Filed Date: 10/9/18.

    Accession Number: 20181009-5284.

    Comments Due: 5 p.m. ET 10/30/18.

    Docket Numbers: ER19-76-000.

    Applicants: Keystone Power LLC.

    Description: § 205(d) Rate Filing: Keystone MBR Tariff Revisions to be effective 10/10/2018.

    Filed Date: 10/10/18.

    Accession Number: 20181010-5000.

    Comments Due: 5 p.m. ET 10/31/18.

    Docket Numbers: ER19-77-000.

    Applicants: Conemaugh Power LLC.

    Description: § 205(d) Rate Filing: Conemaugh MBR Tariff Revisions to be effective 10/10/2018.

    Filed Date: 10/10/18.

    Accession Number: 20181010-5002.

    Comments Due: 5 p.m. ET 10/31/18.

    Docket Numbers: ER19-78-000.

    Applicants: Panther Creek Power Operating, LLC.

    Description: § 205(d) Rate Filing: Panther Creek MBR Tariff Revisions to be effective 10/10/2018.

    Filed Date: 10/10/18.

    Accession Number: 20181010-5004.

    Comments Due: 5 p.m. ET 10/31/18.

    Docket Numbers: ER19-79-000.

    Applicants: PJM Interconnection, L.L.C.

    Description: § 205(d) Rate Filing: Original ISA and CSA, SA Nos. 5212 and 5213; Queue No. AB2-077/AB2-078/AB2-079 to be effective 9/10/2018.

    Filed Date: 10/10/18.

    Accession Number: 20181010-5044.

    Comments Due: 5 p.m. ET 10/31/18.

    Docket Numbers: ER19-80-000.

    Applicants: PJM Interconnection, L.L.C.

    Description: § 205(d) Rate Filing: Revisions to OA, Schedule 6, sec. 1.5 re: Market Efficiency Process Enhancements to be effective 12/10/2018.

    Filed Date: 10/10/18.

    Accession Number: 20181010-5045.

    Comments Due: 5 p.m. ET 10/31/18.

    Docket Numbers: ER19-81-000.

    Applicants: Athens Energy, LLC.

    Description: Report Filing: Refund Report (ER17-1954) to be effective N/A.

    Filed Date: 10/10/18.

    Accession Number: 20181010-5104.

    Comments Due: 5 p.m. ET 10/31/18.

    Docket Numbers: ER19-81-000.

    Applicants: Athens Energy, LLC.

    Description: Baseline eTariff Filing: Application for Market-Based Rates to be effective 10/10/2018.

    Filed Date: 10/10/18.

    Accession Number: 20181010-5100.

    Comments Due: 5 p.m. ET 10/31/18.

    Docket Numbers: ER19-82-000.

    Applicants: AEP Texas Inc.

    Description: § 205(d) Rate Filing: AEPTX-La Chalupa Interconnection Agreement to be effective 9/28/2018.

    Filed Date: 10/10/18.

    Accession Number: 20181010-5103.

    Comments Due: 5 p.m. ET 10/31/18.

    Docket Numbers: ER19-83-000.

    Applicants: AEP Texas Inc.

    Description: § 205(d) Rate Filing: AEPTX-OCI Alamo 6 System Upgrade Agreement Cancellation to be effective 9/18/2018.

    Filed Date: 10/10/18.

    Accession Number: 20181010-5107.

    Comments Due: 5 p.m. ET 10/31/18.

    Docket Numbers: ER19-84-000.

    Applicants: ISO New England Inc., New England Power Pool Participants Committee.

    Description: § 205(d) Rate Filing: Enhanced Storage Participation Revisions to be effective 4/1/2019.

    Filed Date: 10/10/18.

    Accession Number: 20181010-5114.

    Comments Due: 5 p.m. ET 10/31/18.

    The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.

    Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.

    eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: October 10, 2018. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2018-22709 Filed 10-17-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Combined Notice of Filings #2

    Take notice that the Commission received the following electric rate filings:

    Docket Numbers: ER16-471-002.

    Applicants: Midcontinent Independent System Operator, Inc., Merricourt Power Partners LLC.

    Description: Pre-Arranged/Pre-Agreed (Settlement and Settlement Agreement) Filing of the Midcontinent Independent System Operator, Inc., et al.

    Filed Date: 10/11/18.

    Accession Number: 20181011-5180.

    Comments Due: 5 p.m. ET 11/1/18.

    Docket Numbers: ER18-2194-001.

    Applicants: Fox Creek Farm Solar, LLC.

    Description: Tariff Amendment: Amendment to 1 to be effective 10/23/2018.

    Filed Date: 10/12/18.

    Accession Number: 20181012-5141.

    Comments Due: 5 p.m. ET 11/2/18.

    Docket Numbers: ER19-98-000.

    Applicants: Midcontinent Independent System Operator, Inc.

    Description: § 205(d) Rate Filing: 2018-10-12_Filing to revise Attachment WW to be effective 12/12/2018.

    Filed Date: 10/12/18.

    Accession Number: 20181012-5084.

    Comments Due: 5 p.m. ET 11/2/18.

    Docket Numbers: ER19-99-000.

    Applicants: PJM Interconnection, L.L.C.

    Description: § 205(d) Rate Filing: Revisions to the PJM OATT to reflect AMPT as a Transmission Own to be effective 12/14/2018.

    Filed Date: 10/12/18.

    Accession Number: 20181012-5086.

    Comments Due: 5 p.m. ET 11/2/18.

    Docket Numbers: ER19-100-000.

    Applicants: PJM Interconnection, L.L.C.

    Description: § 205(d) Rate Filing: Revisions to the CTOA Attachment A to reflect AMPT as a new Transmission Owner to be effective 12/14/2018.

    Filed Date: 10/12/18.

    Accession Number: 20181012-5087.

    Comments Due: 5 p.m. ET 11/2/18.

    Docket Numbers: ER19-101-000.

    Applicants: R-WS Antelope Valley Gen-Tie, LLC.

    Description: § 205(d) Rate Filing: Certificate of Concurrence for Shared Facilities Agreement to be effective 10/14/2018.

    Filed Date: 10/12/18.

    Accession Number: 20181012-5088.

    Comments Due: 5 p.m. ET 11/2/18.

    Docket Numbers: ER19-102-000.

    Applicants: Luminant Energy Company LLC.

    Description: Baseline eTariff Filing: Market-Based Rate Application to be effective 10/13/2018.

    Filed Date: 10/12/18.

    Accession Number: 20181012-5142.

    Comments Due: 5 p.m. ET 11/2/18.

    Docket Numbers: ER19-103-000.

    Applicants: Wisconsin Electric Power Company.

    Description: § 205(d) Rate Filing: WEPCo Formula Rate Tariff Filing to be effective 12/11/2018.

    Filed Date: 10/12/18.

    Accession Number: 20181012-5151.

    Comments Due: 5 p.m. ET 11/2/18.

    The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.

    Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.

    eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: October 12, 2018. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2018-22714 Filed 10-17-18; 8:45 am] BILLING CODE 6717-01-P
    FEDERAL ELECTION COMMISSION Sunshine Act Meeting TIME AND DATE:

    Tuesday, October 23, 2018 at 10:00 a.m.

    PLACE:

    1050 First Street NE, Washington, DC.

    STATUS:

    This meeting will be closed to the public.

    MATTERS TO BE CONSIDERED:

    Compliance matters pursuant to 52 U.S.C. 30109 Matters concerning participation in civil actions or proceedings or arbitration CONTACT PERSON FOR MORE INFORMATION:

    Judith Ingram, Press Officer, Telephone: (202) 694-1220.

    Signed: Dayna C. Brown, Secretary and Clerk of the Commission.
    [FR Doc. 2018-22887 Filed 10-16-18; 4:15 pm] BILLING CODE 6715-01-P
    FEDERAL RESERVE SYSTEM Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company

    The notificants listed below have applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and § 225.41 of the Board's Regulation Y (12 CFR 225.41) to acquire shares of a bank or bank holding company. The factors that are considered in acting on the notices are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)).

    The notices are available for immediate inspection at the Federal Reserve Bank indicated. The notices also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors. Comments must be received not later than November 5, 2018.

    A. Federal Reserve Bank of Minneapolis (Mark A. Rauzi, Vice President), 90 Hennepin Avenue, Minneapolis, Minnesota 55480-0291:

    1. Belva H. Rasmussen 2018-A Irrevocable Trust under Agreement dated April 26, 2018, and the Belva H. Rasmussen 2018-B Irrevocable Trust under Agreement dated April 26, 2018, both of Minneapolis, Minnesota (trustees Chris R. Fitzmorris, Little Canada, Minnesota; Teresa J. Rasmussen, Orono Minnesota; Eva B. Rasmussen, Edina, Minnesota; and Thomas M. Beck, Eden Prairie, Minnesota); to acquire voting shares of Northeast Securities Corporation, Minneapolis, Minnesota, and thereby indirectly acquire shares of Northeast Bank, Minneapolis, Minnesota.

    In addition, the Notificants will join the Rasmussen family shareholder group acting in concert.

    Board of Governors of the Federal Reserve System, October 15, 2018. Yao-Chin Chao, Assistant Secretary of the Board.
    [FR Doc. 2018-22738 Filed 10-17-18; 8:45 am] BILLING CODE P
    FEDERAL RESERVE SYSTEM Formations of, Acquisitions by, and Mergers of Bank Holding Companies

    The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841 et seq.) (BHC Act), Regulation Y (12 CFR part 225), and all other applicable statutes and regulations to become a bank holding company and/or to acquire the assets or the ownership of, control of, or the power to vote shares of a bank or bank holding company and all of the banks and nonbanking companies owned by the bank holding company, including the companies listed below.

    The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The applications will also be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States.

    Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than November 13, 2018.

    A. Federal Reserve Bank of Dallas (Robert L. Triplett III, Senior Vice President) 2200 North Pearl Street, Dallas, Texas 75201-2272:

    1. Dominion Bancshares, Inc., Dallas, Texas; to become a bank holding company by acquiring 100 percent of Grapeland State Bank, Grapeland, Texas.

    Board of Governors of the Federal Reserve System, October 12, 2018. Ann Misback, Secretary of the Board.
    [FR Doc. 2018-22670 Filed 10-17-18; 8:45 am] BILLING CODE P
    FEDERAL RESERVE SYSTEM Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company

    The notificants listed below have applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and § 225.41 of the Board's Regulation Y (12 CFR 225.41) to acquire shares of a bank or bank holding company. The factors that are considered in acting on the notices are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)).

    The notices are available for immediate inspection at the Federal Reserve Bank indicated. The notices also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors. Comments must be received not later than November 1, 2018.

    A. Federal Reserve Bank of Minneapolis (Mark A. Rauzi, Vice President), 90 Hennepin Avenue, Minneapolis, Minnesota 55480-0291:

    1. Matthew Moran, Seattle, Washington; Gellert Dornay, Mercer Island, Washington; and Robert Cumming, Snohomish, Washington; each individually and, with Kevin Johnston, Issaquah, Washington, as a group acting in concert, to acquire voting shares of Ceylon Bancorporation, Inc. and thereby indirectly acquire control of the State Bank of Ceylon, both of Ceylon, Minnesota.

    Board of Governors of the Federal Reserve System, October 12, 2018. Ann Misback, Secretary of the Board.
    [FR Doc. 2018-22671 Filed 10-17-18; 8:45 am] BILLING CODE P
    FEDERAL RETIREMENT THRIFT INVESTMENT Board Meeting October 22, 2018, 8:30 a.m., (In-Person) Open Session 1. Approval of the Minutes of the September 17, 2018 Board Meeting 2. Investment Manager Annual Service Review 3. Monthly Reports (a) Participant Activity (b) Legislative 4. Quarterly Reports (c) Investment Performance (d) Budget Review 5. Mid-Year Financial Audit 6. ORM Annual Report/FEVS Update 7. OEP Annual Report/TSP Health Report 8. Audit/Security Update Closed Session

    Material covered by 5 U.S.C. (c)(9)(B).

    Contact Person for More Information:

    Kimberly Weaver, Director, Office of External Affairs, (202) 942-1640.

    Dated: October 12, 2018. Dharmesh Vashee, Deputy General Counsel, Federal Retirement Thrift Investment Board.
    [FR Doc. 2018-22675 Filed 10-17-18; 8:45 am] BILLING CODE 6760-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [Docket Number CDC-2018-0085, NIOSH-319] Partnership Opportunity To List in a Public Database (PPE-Info) Appropriate Personnel Protective Equipment Products That Protect Workers Against Fentanyl Exposure AGENCY:

    National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).

    ACTION:

    Notice.

    SUMMARY:

    The National Institute for Occupational Safety and Health of the Centers for Disease Control and Prevention announces the opportunity for manufacturers to participate in an evolution of the PPE-Info database to include products identified as protection against fentanyl exposure. To view the notice and related materials, visit https://www.regulations.gov and enter CDC-2018-0085 in the search field and click “Search.”

    DATES:

    Electronic or written comments expressing willingness to participate must be received by November 19, 2018. Other types of comments are not being requested. Product information is not required to be submitted in this timeframe.

    ADDRESSES:

    You may submit comments, identified by CDC-2018-0085; NIOSH-319, by any of the following methods:

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

    Mail: National Institute for Occupational Safety and Health, NIOSH Docket Office, 1090 Tusculum Avenue, MS C-34, Cincinnati, Ohio 45226-1998.

    Instructions: All information received in response to this notice must include the agency name and docket number [CDC-2018-0085; NIOSH-319]. All relevant comments received will be posted without change to https://www.regulations.gov, including any personal information provided. For access to the docket to read background documents or comments received, go to https://www.regulations.gov. All information received in response to this notice will also be available for public examination and copying at the NIOSH Docket Office, 1150 Tusculum Avenue, Room 155, Cincinnati, OH 45226-1998.

    FOR FURTHER INFORMATION CONTACT:

    [email protected], NIOSH, National Personal Protective Technology Laboratory, Office of the Director, 626 Cochrans Mill Road, Building 141, Pittsburgh, PA, 15236, 1-888-654-2294 (a toll free number).

    SUPPLEMENTARY INFORMATION:

    PPE-Info is a collection of national personal protective equipment (PPE) information. The database provides PPE standards setting organizations, manufacturers, suppliers, purchasers, and end users with the ability to conduct general- or advanced-criteria searches of (1) relevant standards, (2) associated product types, (3) target occupational groups, (4) basic conformity assessment specifications, and (5) additional pertinent information. PPE-Info is the only U.S. database that is maintained with comprehensive information about national PPE standards and select product information. Using this collection of information, PPE-Info currently offers the following capabilities:

    • Identification of PPE standards, searchable by PPE type, hazard category, Standards Development Organization, Standard Occupational Classification (SOC) code, standard type, and standard status, with basic- and advanced-search functions;

    • A PPE-Selection Logic Tool for potential Ebola exposure; and

    • Identification of 3rd party testing laboratories whose scope of accreditation includes testing to the identified standard.

    Background: In 2011 NIOSH began an effort to address the recommendations issued by the Institute of Medicine (IOM) in its report “Certifying Personal Protective Technologies: Improving Worker Safety,” which recommended that “NIOSH NPPTL should continue and expand its role in PPT [personal protective technology] conformity assessment. Specifically, NPPTL should expand its role and become the primary clearinghouse for reliable information on non-respirator PPT.” The PPE-Info Database is a key element designed to address this IOM recommendation. First developed in 2012, the PPE-Info website is available for public use at https://wwwn.cdc.gov/PPEinfo. In addition, there is a tutorial for users on the features and use of the current PPE-Info database at https://niosh-connect.adobeconnect.com/p7o6sz3xxt5/.

    Information Needs: NIOSH is expanding the PPE-Info Database as a tool to connect existing protection standards with relevant PPE information for protection against fentanyl and its analogues. This new aspect of the NIOSH PPE-Info Database will allow end users (e.g., emergency responders) to find products (e.g., gloves and coveralls) that are compliant (as confirmed by manufacturer) with the protection standards outlined by the CDC Fentanyl PPE Guidance at https://www.cdc.gov/niosh/topics/fentanyl/risk.html. The objective is to include information about all PPE types associated with the CDC Fentanyl PPE Guidance as the information becomes available. Since there is no single source for this information, NIOSH is requesting that manufacturers provide CDC with their product information directly for input into the database to provide end users with Fentanyl PPE selection options. NIOSH will develop individual Memoranda of Understanding (MOU) with PPE manufacturers to facilitate the sharing of product information. The primary focus of the collaboration with an individual manufacturer will be (1) the receipt of manufacturer product information to be collected and displayed in the NIOSH PPE-Info Database; and (2) the verification, by the manufacturer, of product information displayed in the NIOSH PPE-Info Database. The purpose of these collaborations is to obtain information on all currently available PPE types that comply with the CDC Fentanyl PPE Guidance.

    References Cohen HJ, Liverman CT [2010]. Certifying Personal Protective Technologies: Improving Worker Safety. https://www.nap.edu/catalog/12962/certifying-personal-protective-technologies-improving-worker-safety. Dated: October 15, 2018. Frank J Hearl, Chief of Staff, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention.
    [FR Doc. 2018-22721 Filed 10-17-18; 8:45 am] BILLING CODE 4163-19-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Proposed Information Collection Activity; Comment Request

    Proposed Projects: Office of Child Care CCDF Onsite Monitoring.

    Title: Child Care and Development Fund (CCDF) State Monitoring Compliance Demonstration Packet.

    OMB No.: New.

    Description: The proposed data collection form is designed as part of the evidence collection process of the Onsite Monitoring system and provides states with an opportunity to propose how they, as block-grant recipients, will choose to demonstrate compliance.

    Respondents: 51 States and Territories triennially.

    Annual Burden Estimates Instrument Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Average
  • burden hours
  • per response
  • Total burden
  • hours
  • Compliance Demonstration Chart 17 1 16 272 Document Submission Chart 17 1 80 1,360

    Estimated Total Annual Burden Hours: 1,632 hours.

    In compliance with the requirements of the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. chap 35), the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 330 C Street SW, Washington DC 20201. Attn: ACF Reports Clearance Officer. Email address: [email protected] All requests should be identified by the title of the information collection.

    The Department specifically requests comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication.

    Robert Sargis, Reports Clearance Officer.
    [FR Doc. 2018-22700 Filed 10-17-18; 8:45 am] BILLING CODE 4184-43-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-D-3443] Content of Premarket Submissions for Management of Cybersecurity in Medical Devices; 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 “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.” As more medical devices are becoming interconnected, cybersecurity threats have become more numerous, more frequent, more severe, and more clinically impactful. There is a need to provide manufacturers with specific technical recommendations (e.g., appropriate threat modeling and other premarket testing) to help ensure device cybersecurity. The updates to the existing “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices” guidance is anticipated to better protect against risks, such as ransomware campaigns, that could disrupt clinical operations and delay patient care and risks, such as exploiting a vulnerability that enables attacks on multiple patients. 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 18, 2019 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-2018-D-3443 for “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

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

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

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

    An electronic copy of the guidance document is available for download from the internet. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written requests for a single hard copy of the draft guidance document entitled “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices” to the Office of the Center Director, Guidance and Policy Development, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002 or the Office of Communication, Outreach, and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request.

    FOR FURTHER INFORMATION CONTACT:

    Suzanne Schwartz, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5434, Silver Spring, MD 20993-0002, 301-796-6937, 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, 240-402-7911.

    SUPPLEMENTARY INFORMATION:

    I. Background

    The need for effective cybersecurity to assure medical device functionality and safety has become more important with the increasing use of wireless, internet- and network-connected devices, and the frequent electronic exchange of medical device-related health information. In addition, cybersecurity threats to the healthcare sector have become more frequent, more severe, and more clinically impactful. Cybersecurity incidents have rendered medical devices and hospital networks inoperable, disrupting the delivery of patient care across healthcare facilities in the United States and globally. Such cyberattacks and exploits can delay diagnoses and/or treatment and may lead to patient harm.

    Although FDA issued guidance addressing recommendations for device cybersecurity information in premarket submissions in 2014, 1 the rapidly evolving landscape, and the increased understanding of the threats and their potential mitigations necessitates an updated approach. This draft guidance is intended to provide recommendations to industry regarding cybersecurity device design, labeling, and the documentation that FDA recommends be included in premarket submissions for devices with cybersecurity risk. These recommendations can facilitate an efficient premarket review process and help ensure that marketed medical devices are sufficiently resilient to cybersecurity threats.

    1 “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices—Guidance for Industry and Food and Drug Administration Staff” at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM356190.

    FDA plans to hold a public workshop on January 29th and January 30th, 2019.2 FDA seeks to bring together diverse stakeholders to discuss, in-depth, the draft guidance, “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices” and the subtopic of the draft guidance regarding a Cybersecurity Bill of Materials (CBOM), which can be a critical element in identifying assets, threats, and vulnerabilities.

    2https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm.

    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 Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.

    III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do so by downloading an electronic copy from the internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This guidance document is also available at https://www.regulations.gov or https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. Persons unable to download an electronic copy of “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices” may send an email request to [email protected] to receive an electronic copy of the document. Please use the document number 1825 to identify the guidance you are requesting.

    IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of information. 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 the following FDA regulations and guidance have been approved by OMB as listed in the following table:

    21 CFR part or guidance Topic OMB control No. 807, subpart E Premarket notification 0910-0120 814, subparts A through E Premarket approval 0910-0231 814, subpart H Humanitarian Device Exemption 0910-0332 812 Investigational Device Exemption 0910-0078 “De Novo Classification Process (Evaluation of Automatic Class III Designation)” De Novo classification process 0910-0844 801 Medical Device Labeling Regulations 0910-0485 820 Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation 0910-0073 V. Other Issues for Consideration

    The Agency invites comments on the “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices” draft guidance, in general, and on the following topics, in particular:

    • Definition of CBOM:

    ○ Whether a CBOM should include both software and hardware components

    • Type of information and level of detail that should be included in a CBOM

    • Effective mechanisms for sharing CBOM information

    • Format the CBOM should take:

    ○ Available formats that could be leveraged ○ Whether multiple formats would be able to co-exist

    • Appropriate frequency for updating the CBOM

    • Features of a CBOM that would make it automatically consumable

    Dated: October 12, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-22697 Filed 10-17-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2017-E-6698 and FDA-2017-E-6699] Determination of Regulatory Review Period for Purposes of Patent Extension; OCREVUS AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for OCREVUS and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.

    DATES:

    Anyone with knowledge that any of the dates as published (see the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by December 17, 2018. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by April 16, 2019. See “Petitions” in the SUPPLEMENTARY INFORMATION section for more information.

    ADDRESSES:

    You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before December 17, 2018. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of December 17, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

    Electronic Submissions

    Submit electronic comments in the following way:

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

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

    Written/Paper Submissions

    Submit written/paper submissions as follows:

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

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

    Instructions: All submissions received must include the Docket Nos. FDA-2017-E-6698 and FDA-2017-E-6699 for ”Determination of Regulatory Review Period for Purposes of Patent Extension; OCREVUS.” Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

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

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

    FOR FURTHER INFORMATION CONTACT:

    Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.

    SUPPLEMENTARY INFORMATION: I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.

    A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human biological products, the testing phase begins when the exemption to permit the clinical investigations of the biological product becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human biological product and continues until FDA grants permission to market the biological product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human biological product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).

    FDA has approved for marketing the human biologic product OCREVUS (ocrelizumab). OCREVUS is indicated for the treatment of patients with relapsing or primary progressive forms of multiple sclerosis. Subsequent to this approval, the USPTO received a patent term restoration application for OCREVUS (U.S. Patent Nos. 7,799,900 and 8,562,992) from Genentech, Inc., and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated February 6, 2018, FDA advised the USPTO that this human biological product had undergone a regulatory review period and that the approval of OCREVUS represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.

    II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for OCREVUS is 4,844 days. Of this time, 4,509 days occurred during the testing phase of the regulatory review period, while 335 days occurred during the approval phase. These periods of time were derived from the following dates:

    1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: December 25, 2003. FDA has verified the applicant's claim that the date the investigational new drug application became effective was on December 25, 2003.

    2. The date the application was initially submitted with respect to the human biological product under section 351 of the Public Health Service Act (42 U.S.C. 262): April 28, 2016. FDA has verified the applicant's claim that the biologics license application (BLA) for OCREVUS (BLA 761053) was initially submitted on April 28, 2016.

    3. The date the application was approved: March 28, 2017. FDA has verified the applicant's claim that BLA 761053 was approved on March 28, 2017.

    This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, this applicant seeks 1,358 days or 795 days of patent term extension.

    III. Petitions

    Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as specified in § 60.30 (21 CFR 60.30), any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must comply with all the requirements of § 60.30, including but not limited to: Must be timely (see DATES), must be filed in accordance with § 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30.

    Submit petitions electronically to https://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: October 12, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-22699 Filed 10-17-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-E-3918] Determination of Regulatory Review Period for Purposes of Patent Extension; AFSTYLA AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for AFSTYLA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.

    DATES:

    Anyone with knowledge that any of the dates as published (see the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by December 17, 2018. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by April 16, 2019. See “Petitions” in the SUPPLEMENTARY INFORMATION section for more information.

    ADDRESSES:

    You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before December 17, 2018. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of December 17, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

    Electronic Submissions

    Submit electronic comments in the following way:

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

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

    Written/Paper Submissions

    Submit written/paper submissions as follows:

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

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

    Instructions: All submissions received must include the Docket No. FDA-2016-E-3918 for “Determination of Regulatory Review Period for Purposes of Patent Extension; AFSTYLA.” Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

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

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

    FOR FURTHER INFORMATION CONTACT:

    Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.

    SUPPLEMENTARY INFORMATION:

    I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.

    A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human biological products, the testing phase begins when the exemption to permit the clinical investigations of the biological product becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human biological product and continues until FDA grants permission to market the biological product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human biological product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).

    FDA has approved for marketing the human biologic product AFSTYLA (Antihemophilic Factor (Recombinant), Single Chain). AFSTYLA is indicated in children and adults with hemophilia A (congenital Factor VIII deficiency) for: (1) On-demand treatment and control of bleeding episodes, (2) routine prophylaxis to reduce the frequency of bleeding episodes, and (3) perioperative management of bleeding. Subsequent to this approval, the USPTO received a patent term restoration application for AFSTYLA (U.S. Patent No. 7,041,635) from SK Chemicals Co, LTD., and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated August 1, 2017, FDA advised the USPTO that this human biological product had undergone a regulatory review period and that the approval of AFSTYLA represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.

    II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for AFSTYLA is 1,734 days. Of this time, 1,371 days occurred during the testing phase of the regulatory review period, while 363 days occurred during the approval phase. These periods of time were derived from the following dates:

    1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: August 28, 2011. FDA has verified the applicant's claim that the date the investigational new drug application became effective was on August 28, 2011.

    2. The date the application was initially submitted with respect to the human biological product under section 351 of the Public Health Service Act (42 U.S.C. 262): May 29, 2015. FDA has verified the applicant's claim that the biologics license application (BLA) for AFSTYLA (BLA 125591) was initially submitted on May 29, 2015.

    3. The date the application was approved: May 25, 2016. FDA has verified the applicant's claim that BLA 125591 was approved on May 25, 2016.

    This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,047 days of patent term extension.

    III. Petitions

    Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as specified in § 60.30 (21 CFR 60.30), any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must comply with all the requirements of § 60.30, including but not limited to: Must be timely (see DATES), must be filed in accordance with § 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30.

    Submit petitions electronically to https://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: October 12, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-22696 Filed 10-17-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Public Comment Request: Information Collection Request Title: Bureau of Health Workforce Performance Data Collection, OMB No. 0915-0061—Revision AGENCY:

    Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS).

    ACTION:

    Notice.

    SUMMARY:

    In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

    DATES:

    Comments on this ICR should be received no later than December 17, 2018.

    ADDRESSES:

    Submit your comments to [email protected] or mail the HRSA Information Collection Clearance Officer, Room 14N39, 5600 Fishers Lane, Rockville, MD 20857.

    FOR FURTHER INFORMATION CONTACT:

    To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email [email protected] or call Lisa Wright-Solomon, the HRSA Information Collection Clearance Officer at (301) 443-1984.

    SUPPLEMENTARY INFORMATION:

    When submitting comments or requesting information, please include the information request collection title for reference.

    Information Collection Request Title: Bureau of Health Workforce Performance Data Collection, OMB No. 0915-0061—Revision.

    Abstract: Over 40 Bureau of Health Workforce (BHW) programs award grants to health professions schools and training programs across the United States to develop, expand, and enhance training, and to strengthen the distribution of the health workforce. These programs are governed by the Public Health Service Act (42 U.S.C. 201 et seq.), specifically Titles III, VII, and VIII. Performance information about these health professions programs is collected in the HRSA Performance Report for Grants and Cooperative Agreements. Specific performance measurement requirements for each program may be found on the HRSA website at https://bhw.hrsa.gov/grants/reportonyourgrant. Data collection activities consist of two reports, an annual progress and annual performance report that are submitted by awardees to comply with statutory and programmatic requirements for performance measurement and evaluation (including specific Title III, VII and VIII requirements), as well as the Government Performance and Results Act of 1993 (GPRA) and the GPRA Modernization Act of 2010 requirements. The performance measures were last revised in 2016 to ensure they addressed programmatic changes, met evolving program management needs, and responded to emerging workforce concerns. As these changes successfully enabled BHW to demonstrate accurate outputs and outcomes associated with the health professions programs, BHW will continue with its current performance management strategy and make only minor changes that reflect new HHS and HRSA priorities with the addition of a question asking awardees how many trainees received training in telehealth, substance use treatment, and/or medication-assisted treatment.

    Need and Proposed Use of the Information: The purpose of the proposed data collection is to continue analysis and reporting of awardee training activities and educational programs, identify intended practice locations, and report outcomes of funded initiatives. Data collected from these grant programs will also provide a description of the program activities of approximately 1,500 reporting grantees to inform policymakers on the barriers, opportunities, and outcomes involved in health care workforce development. The proposed measures focus on five key outcomes: (1) Increasing the workforce supply of well-educated practitioners in needed professions; (2) increasing the number of practitioners that practice in underserved and rural areas; (3) enhancing the quality of education; (4) increasing the recruitment, training, and placement of under-represented groups in the health workforce; and (5) supporting educational infrastructure to increase the capacity to train more health professionals in high demand areas.

    Likely Respondents: Respondents are awardees of BHW health professions grant programs.

    Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose or provide the information requested. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information; to search data sources; to complete and review the collection of information; and to transmit or otherwise disclose the information. The total annual burden hours estimated for this ICR are summarized in the table below.

    Total Estimated Annualized Burden Hours Form name Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Total
  • responses
  • Average
  • burden per
  • response
  • (in hours)
  • Total
  • burden
  • hours
  • Direct Financial Support Program 500 1 500 3.1 1,550 Infrastructure Program 100 1 100 4.5 450 Multipurpose or Hybrid Program 900 1 900 4.3 3,870 1,500 1,500 5,870

    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 P. McNulty, Acting Director, Division of the Executive Secretariat.
    [FR Doc. 2018-22708 Filed 10-17-18; 8:45 am] BILLING CODE 4165-15-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary Posting of the National Security Presidential Memorandum 14, “Support for National Biodefense” ACTION:

    Notice.

    SUMMARY:

    National Security Presidential Memorandum 14 directs implementation of the National Biodefense Strategy. The Secretary is authorized and directed to publish the Memorandum in the Federal Register.

    DATES:

    National Security Presidential Memorandum 14 was signed on September 18, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Robert P. Kadlec, MD, MTM&H, MS, Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, 200 Independence Avenue SW, Washington, DC 20201; Telephone: 202-205-2882.

    SUPPLEMENTARY INFORMATION:

    National Security Presidential Memorandum: Support for National Biodefense.

    Memorandum for: The Vice President; The Secretary of State; The Secretary of the Treasury; The Secretary of Defense; The Attorney General; The Secretary of the Interior; The Secretary of Agriculture; The Secretary of Commerce; The Secretary of Labor; The Secretary of Health and Human Services; The Secretary of Transportation; The Secretary of Energy; The Secretary of Veterans Affairs; The Secretary of Homeland Security; Assistant to the President and Chief of Staff; Administrator of the Environmental Protection Agency; Director of the Office of Management and Budget; The Representative of the United States to the United Nations; Director of National Intelligence; Assistant to the President for Science and Technology and Director of the Office of Science and Technology Policy; Chairman of the Joint Chiefs of Staff; Administrator of the United States Agency for International Development; Director of the Federal Bureau of Investigation.

    It is a vital interest of the United States to prepare for, counter, respond to, and recover from biological incidents at home and abroad. Nearly all executive departments and agencies (agencies) contribute to the biodefense mission of the United States Government. Those contributions occur through a variety of authorities and programs. To ensure an integrated, comprehensive approach, agencies shall coordinate and manage biodefense activities in support of the broader biodefense enterprise, which consists of all stakeholders with a role in the detection of, prevention of, preparedness for, response to, and recovery from biological incidents, including Federal, State, local, tribal, and territorial governments, the private sector, and international partners.

    Section 1. Policy. (a) It is the policy of the United States to preserve our national and economic security by protecting the Nation from biological threats. Acting within the biodefense enterprise, the United States Government will undertake actions at home and with partners abroad to reduce the risk of natural, accidental, and deliberate biological threats to humans, animals, agriculture, and the environment that have the potential to significantly affect the national and economic security of the United States.

    (b) The foundation for the United States Government's role in the biodefense enterprise is the National Biodefense Strategy and its implementation plan (Strategy), which serve as the authoritative sources for the goals, objectives, and definitions for United States Government activities in support of the broader biodefense enterprise. Agency biodefense activities shall be conducted consistent with section 1086 of the National Defense Authorization Act for Fiscal Year 2017 and the Strategy, including activities undertaken to implement prior Executive Orders and Presidential Directives, such as Homeland Security Presidential Directive (HSPD)-5 of February 28, 2003 (Management of Domestic Incidents); HSPD-9 of January 30, 2004 (Defense of United States Agriculture and Food); HSPD-18 of January 31, 2007 (Medical Countermeasures against Weapons of Mass Destruction); HSPD-21 of October 18, 2007 (Public Health and Medical Preparedness); Executive Order 13676 of September 18, 2014 (Combating Antibiotic-Resistant Bacteria); and Executive Order 13747 of November 4, 2016 (Advancing the Global Health Security Agenda To Achieve a World Safe and Secure From Infectious Disease Threats).

    Sec. 2. Implementation. The policy set forth in section 1 of this memorandum shall be implemented, to the extent permitted by law and available appropriations, and subject to the internal programmatic and budgetary processes of the agencies, as follows:

    (a) Consistent with the Strategy, the heads of agencies shall:

    (i) Prioritize the implementation of the Strategy and include Strategy-related activities within their strategic planning and budgetary processes;

    (ii) coordinate their biodefense policies with other agencies that have responsibilities or capabilities pertaining to biodefense, as well as with appropriate non-Federal entities;

    (iii) share information, as appropriate, and coordinate decision-making related to the biodefense enterprise; and

    (iv) monitor, evaluate, and hold their agencies accountable for implementation of the Strategy.

    (b) The Assistant to the President for National Security Affairs (APNSA) shall serve as the lead for policy coordination and review, acting through the process described in National Security Presidential Memorandum (NSPM)-4 of April 4, 2017 (Organization of the National Security Council, the Homeland Security Council, and Subcommittees), to provide strategic input and facilitate policy integration for Federal biodefense efforts.

    (c) There is hereby established a Biodefense Steering Committee (Committee), which shall be chaired by the Secretary of Health and Human Services (Secretary). The other members of the Committee shall include the Secretary of State, the Secretary of Defense, the Attorney General, the Secretary of Agriculture, the Secretary of Veterans Affairs, the Secretary of Homeland Security, and the Administrator of the Environmental Protection Agency. The heads of other agencies with responsibilities or capabilities pertaining to biodefense shall participate at the invitation of the Committee, as appropriate. The Committee shall be responsible for monitoring and coordinating the implementation of the Strategy. The Committee shall seek consensus, with disagreements being addressed through the NSPM-4 process. The Committee may establish appropriate consultative or advisory mechanisms to facilitate interaction with non-Federal stakeholders. The Secretary, as the Chair of the Committee, shall serve as the Federal lead in coordinating implementation of the Strategy.

    (d) To assist the Committee in carrying out the responsibilities described in subsection (c) of this section, the Secretary shall, within 90 days of the date of this memorandum, establish a Biodefense Coordination Team (Team) administratively located within the Department of Health and Human Services.

    (i) The Secretary shall designate a senior official of, or detailed to, the Department of Health and Human Services to serve as the director of the Team, who shall report to the Secretary.

    (ii) The Secretary, the Secretary of State, the Secretary of Defense, the Attorney General, the Secretary of Agriculture, the Secretary of Veterans Affairs, the Secretary of Homeland Security, the Administrator of the Environmental Protection Agency, and the heads of other agencies with responsibilities or capabilities pertaining to biodefense shall support the work of the Team, including, where appropriate, through the detail of personnel to the Team, consistent with law.

    (iii) The Secretary, in consultation with the Committee, shall ensure that appropriate resources are provided by the Department of Health and Human Services to facilitate the Team's activities.

    (iv) The Team shall, in consultation with existing governance bodies with responsibilities or capabilities pertaining to biodefense, assist the Committee in monitoring and coordinating implementation of the Strategy. The Team may convene working groups with relevant agencies as appropriate. In addition, the Team shall, on an ongoing basis, maintain awareness of biodefense activities conducted by agencies, relevant interagency entities, and non Federal partners in the broader biodefense enterprise, including relevant private sector stakeholders. The Team shall identify opportunities to increase coordination with non-Federal partners, including international organizations. Subject to the approval of the Committee, the Team shall establish policies, processes, and procedures to govern its activities.

    (v) The Secretary shall notify the APNSA when the Team is established.

    (e) To ensure effective implementation of the Strategy, within 30 days of the formation of the Team and annually thereafter in alignment with the annual budget process, the Secretary shall submit written requests for information to the heads of agencies identified by the Committee as having responsibilities pertaining to biodefense (Covered Officials), including the following:

    (i) The Secretary of State;

    (ii) the Secretary of the Treasury;

    (iii) the Secretary of Defense;

    (iv) the Attorney General;

    (v) the Secretary of the Interior;

    (vi) the Secretary of Agriculture;

    (vii) the Secretary of Commerce;

    (viii) the Secretary of Labor;

    (ix) the Secretary of Health and Human Services;

    (x) the Secretary of Transportation;

    (xi) the Secretary of Energy;

    (xii) the Secretary of Veterans Affairs;

    (xiii) the Secretary of Homeland Security;

    (xiv) the Administrator of the Environmental Protection Agency;

    (xv) the Director of National Intelligence;

    (xvi) the Administrator of the United States Agency for International Development; and

    (xvii) the Director of the Federal Bureau of Investigation.

    (f) These requests shall ask how agency programs and activities contribute to the objectives of the Strategy. Covered Officials shall respond to these requests within 60 days of receipt of the request through a Biodefense Memorandum, as described in paragraphs (i)-(ii) of this subsection.

    (i) The Biodefense Memorandum shall identify those activities, programs, and projects that are planned, programmed, or have been executed that advance or are expected to advance the Strategy; quantify, to the extent feasible, resources allocated to biodefense within the agency; assess the extent to which the goals, objectives, and sub-objectives of the Strategy are being met; and identify impediments to timely and effective implementation and options for their resolution. Each agency shall provide its Biodefense Memorandum to the Committee, the Team, the National Security Council (NSC) staff, and the Office of Management and Budget (OMB). The Team shall distribute the collected Memoranda to Covered Officials.

    (ii) Covered Officials are not required to provide information on specific law enforcement activities, counterproliferation activities, military plans or operations, intelligence activities, or criminal investigations.

    (g) The Team, as informed by each Biodefense Memorandum and consultations with the agencies, shall prepare a Biodefense Assessment (Assessment) to identify any gaps, shortfalls, and redundancies; describe any challenges to the implementation and execution of the Strategy; and recommend any necessary updates or changes to the Strategy. The Assessment shall include an analysis of the extent to which current United States Government resources support the goals and objectives of the Strategy, how existing programs and resources could be better executed or allocated to align with the Strategy, and how additional resources could, if available, be applied to support the goals of the Strategy. The Team shall coordinate the Assessment with the NSC staff and the OMB prior to its finalization. The Assessment shall be submitted to the Committee for approval and provided to the APNSA and the Director of the OMB within 180 days of the formation of the Team and annually thereafter.

    (h) Each year, within 90 days of the approval of the Assessment, the Team shall summarize the Assessment and prepare, subject to the approval of the Committee and in coordination with the NSC staff, a public report describing the actions taken to reduce the risk of biological threats to the American people.

    (i) Each year, Covered Officials, in coordination with the APNSA through the NSPM-4 process, shall prepare joint policy guidance (Guidance) on priority areas of biodefense. The Guidance shall be informed by the Assessment, and Covered Officials shall consider the Guidance when they develop their annual budget requests. Based on the Guidance, the Covered Officials shall include in their respective annual budget requests to the OMB information on the programs within the budget requests that support the implementation of the Strategy and conform to budget formulation requirements established by the OMB, including specified funding levels. Concurrently, Covered Officials shall submit a memorandum to the NSC staff and the OMB conveying their response to the policy Guidance. Covered Officials shall ensure that new and existing activities are prioritized and can be accommodated within budget guidance from the OMB.

    (j) Within 120 days of the issuance of this memorandum, the Team, in coordination with the NSC staff through the NSPM-4 process, shall develop a proposal for metrics, milestones, end states, and roles and responsibilities of agencies, with respect to biodefense activities, particularly in meeting the goals, objectives, and sub-objectives of the Strategy. This proposal will be approved by Deputies, consistent with the NSPM-4 process.

    (k) Within 2 years of the date of this memorandum, and every 2 years thereafter, Covered Officials shall review and, as appropriate, revise the Strategy. The APNSA, acting through the NSC staff, shall coordinate the development of updates to the Strategy. The updates to the Strategy shall be submitted to the President through the APNSA and, to the extent permitted by and consistent with applicable law and policy, released to the public.

    (l) The APNSA, with the approval of every member of the Committee, may designate a different member of the Committee to serve as Chair of the Committee and perform the responsibilities specified in subsection 2(c).

    Sec. 3. Earlier Presidential Actions. (a) Presidential Policy Directive-2 of November 23, 2009 (Implementation of the National Strategy for Countering Biological Threats) and HSPD 10/National Security Presidential Directive-33 of April 21, 2004 (National Policy for Biodefense) are hereby superseded and replaced.

    Sec. 4. General Provisions. (a) Nothing in this memorandum shall be construed to impair or otherwise affect:

    (i) The authority granted by law to an executive department or agency, or the head thereof; or

    (ii) the functions of the Director of the OMB relating to budgetary, administrative, or legislative proposals.

    (b) This memorandum shall be implemented consistent with applicable laws and subject to the availability of appropriations.

    (c) This memorandum is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.

    (d) The Secretary is hereby authorized and directed to publish this memorandum in the Federal Register.

    Dated: October 12, 2018. Alex M. Azar II, Secretary.
    [FR Doc. 2018-22742 Filed 10-17-18; 8:45 am] BILLING CODE P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing; Correction AGENCY:

    National Institutes of Health, HHS.

    ACTION:

    Notice; correction.

    SUMMARY:

    The Department of Health and Human Services, National Institutes of Health published a Notice in the Federal Register on October 9, 2018. That Notice inadvertently contained an error within the SUPPLEMENTARY INFORMATION.

    FOR FURTHER INFORMATION CONTACT:

    Peter Soukas, J.D., 301-594-8730; [email protected] Licensing information and copies of the patent applications listed below may be obtained by communicating with the indicated licensing contact at the Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases, 5601 Fishers Lane, Rockville, MD, 20852; tel. 301-496-2644. A signed Confidential Disclosure Agreement will be required to receive copies of unpublished patent applications.

    SUPPLEMENTARY INFORMATION:

    Correction

    In the Federal Register of October 9, 2018, in FR Doc. 2018-21764, on page 50667, in the first column, correct “HHS Reference No. E-018-2018/0” to read “HHS Reference No. E-167-2018-0”.

    Dated: October 12, 2018. Suzanne M. Frisbie, Deputy Director, Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases.
    [FR Doc. 2018-22722 Filed 10-17-18; 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; Member Conflict: Animal Models of Epilepsy, Stroke and Spinal Cord Injury.

    Date: October 31, 2018.

    Time: 11:00 a.m. to 2:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call).

    Contact Person: Paula Elyse Schauwecker, Ph.D., Scientific Review Officer, National Institutes of Health, Center for Scientific Review, 6701 Rockledge Drive, Room 5211, Bethesda, MD 20892, 301-760-8207, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR—Shared Instrumentation: Flow Cytometry.

    Date: November 6, 2018.

    Time: 10:00 a.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).

    Contact Person: 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].

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Eye function Assessments, Genetics and Interventions.

    Date: November 7, 2018.

    Time: 10:30 a.m. to 12:30 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call).

    Contact Person: 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; Small Business: Biomaterials, Delivery and Nanotechnology.

    Date: November 13, 2018.

    Time: 8:00 a.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Hilton Washington/Rockville, 1750 Rockville Pike, Rockville, MD 20852.

    Contact Person: Nitsa Rosenzweig, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4152, MSC 7760, Bethesda, MD 20892, (301) 404-7419, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Small Business: Health Informatics.

    Date: November 13-14, 2018.

    Time: 8:00 a.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: The William F. Bolger Center, 9600 Newbridge Drive, Potomac, MD 20854.

    Contact Person: Xin Yuan, MD, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3141, Bethesda, MD 20892, 301-827-7245, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR Panel: Decision Making and Emotion Function in Aging and AD.

    Date: November 13, 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: Biao Tian, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3089B, MSC 7848, Bethesda, MD 20892, (301) 402-4411, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Small Business: Non-HIV Anti-Infective Therapeutics.

    Date: November 14-15, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Cambria Hotel Rockville, 1 Helen Heneghan Way, Rockville, MD 20850.

    Contact Person: Neerja Kaushik-Basu, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3198, MSC 7808, Bethesda, MD 20892, (301) 435-2306, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Small Business: Cell and Molecular Biology.

    Date: November 14-15, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Hotel Nikko San Francisco, 222 Mason Street, San Francisco, CA 94102.

    Contact Person: Amy Kathleen Wernimont, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6198, Bethesda, MD 20892, 301-827-6427, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Pain Mechanisms.

    Date: November 14-15, 2018.

    Time: 8:00 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: 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]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Topics in Bacterial Pathogenesis and Host Interactions.

    Date: November 14, 2018.

    Time: 9:30 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: Soheyla Saadi, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3211, MSC 7808, Bethesda, MD 20892, 301-435-0903, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Fellowships: Endocrinology, Metabolism, Nutrition, and Reproductive Science.

    Date: November 14, 2018.

    Time: 1:00 p.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).

    Contact Person: Gary Hunnicutt, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6164, MSC 7892, Bethesda, MD 20892, 301-435-0229, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR: Adverse Drug Reaction Research.

    Date: November 14, 2018.

    Time: 1:00 p.m. to 3:30 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).

    Contact Person: Alexander D. Politis, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3210, MSC 7808, Bethesda, MD 20892, (301) 435-1150, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Innate Immunity, Host Defense and Vaccines.

    Date: November 14, 2018.

    Time: 1:00 p.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).

    Contact Person: Deborah Hodge, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4207, MSC 7812, Bethesda, MD 20892, (301) 435-1238, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR Panel: Improvement of Animal Models for Stem Cell-Based Regenerative Medicine.

    Date: November 14, 2018.

    Time: 2:00 p.m. to 4:30 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call).

    Contact Person: Maqsood A. Wani, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 2114, MSC 7814, Bethesda, MD 20892, 301-435-2270, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR Panel: Improvement of Animal Models for Stem Cell-Based Regenerative Medicine.

    Date: November 14, 2018.

    Time: 2:00 p.m. to 4:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call).

    Contact Person: Rass M. Shayiq, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 2182, MSC 7818, Bethesda, MD 20892, (301) 435-2359, [email protected]

    (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research; 93.306, 93.333, 93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893, National Institutes of Health, HHS)
    Dated: October 11, 2018. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-22680 Filed 10-17-18; 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: AIDS and Related Research Integrated Review Group; HIV Comorbidities and Clinical Studies Study Section.

    Date: November 14-15, 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: Dimitrios Nikolaos Vatakis, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3190, Bethesda, MD 20892, 301-827-7480, [email protected].

    Name of Committee: AIDS and Related Research Integrated Review Group; HIV/AIDS Intra- and Inter-personal Determinants and Behavioral Interventions Study Section.

    Date: November 15-16, 2018.

    Time: 8:00 a.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Sheraton Suites—Old Town Alexandria, 801 N Saint Asaph St., Alexandria, VA 22314.

    Contact Person: Mark P. Rubert, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5218, MSC 7852, Bethesda, MD 20892, 301-806-6596, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR17-094: NIGMS Maximizing Investigators' Research Award (R35).

    Date: November 15-16, 2018.

    Time: 8:00 a.m. to 7:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Bolger Center, 9600 Newbridge Drive, Potomac, MD 20854.

    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: Center for Scientific Review Special Emphasis Panel; Shared Instrumentation: High-End or Shared Light Microscope Systems (S10).

    Date: November 15-16, 2018.

    Time: 8:00 a.m. to 5:30 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Doubletree Hotel Bethesda (Formerly Holiday Inn Select), 8120 Wisconsin Avenue, Bethesda, MD 20814.

    Contact Person: Charles Selden, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive Room 5187 MSC 7840, Bethesda, MD 20892, 301-451-3388, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Small Business: Medical Imaging.

    Date: November 15-16, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National 4-H Conference Center, 7100 Connecticut Avenue, Chevy Chase, MD 20815.

    Contact Person: Leonid V. Tsap, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5128, MSC 7854, Bethesda, MD 20892, (301) 435-2507, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Small Business: Biomedical Sensing, Measurement and Instrument.

    Date: November 15-16, 2018.

    Time: 8:00 a.m. to 3:00 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: Inna Gorshkova, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, 301-435-1784, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Fellowships: Cancer Immunology and Immunotherapy.

    Date: November 15-16, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Hilton Washington/Rockville, 1750 Rockville Pike, Rockville, MD 20852.

    Contact Person: Sarita Kandula Sastry, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20782, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Immune Responses and Vaccines to Non-HIV Microbial Infections.

    Date: November 15-16, 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: Andrea Keane-Myers, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4218, Bethesda, MD 20892, 301-435-1221, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Exploration of Antimicrobial Therapeutics and Resistance.

    Date: November 15-16, 2018.

    Time: 8:00 a.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Marines' Memorial Club & Hotel, 609 Sutter Street, San Francisco, CA 94102.

    Contact Person: Susan Daum, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Dr. Room 3202, Bethesda, MD 20892, 301-827-7233, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Small Business: Cancer Drug Development and Therapeutics.

    Date: November 15-16, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Marines' Memorial Club & Hotel, 609 Sutter Street, San Francisco, CA 94102.

    Contact Person: Lilia Topol, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6192, MSC 7804, Bethesda, MD 20892, 301-451-0131, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Small Business Hematology.

    Date: November 15-16, 2018.

    Time: 9:00 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: Bukhtiar H Shah, DVM, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4120, MSC 7802, Bethesda, MD 20892, 301-806-7314, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Small Business Hematology.

    Date: November 15-16, 2018.

    Time: 9:00 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: Katherine M. Malinda, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4140, MSC 7814, Bethesda, MD 20892, 301-435-0912, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR Panel: Electronic Nicotine Delivery Systems (ENDS): Population, Clinical and Applied Prevention Research.

    Date: November 15, 2018.

    Time: 10:00 a.m. to 4:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892.

    Contact Person: Kristen Prentice, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3112, MSC 7808, Bethesda, MD 20892, 301-496-0726, prenticekj[email protected].

    Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR Panel: Electronic Nicotine Delivery Systems (ENDS): Population, Clinical and Applied Prevention Research.

    Date: November 15, 2018.

    Time: 10:00 a.m. to 4:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892.

    Contact Person: Miriam Mintzer, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3108, Bethesda, MD 20892, 301-523-0646, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Fellowships: Biological Chemistry and Macromolecular Biophysics Chemistry.

    Date: November 15, 2018.

    Time: 10:00 a.m. to 4:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).

    Contact Person: Mike Radtke, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4176, MSC 7806, Bethesda, MD 20892, 301-435-1728, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Tumor Biology.

    Date: November 15, 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 (Telephone Conference Call).

    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, 301-451-4467, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Focus on Antimicrobial Drug Development and Resistance.

    Date: November 16, 2018.

    Time: 8:00 a.m. to 9:00 a.m.

    Agenda: To review and evaluate grant applications.

    Place: Marines' Memorial Club & Hotel, 609 Sutter Street, San Francisco, CA 94102.

    Contact Person: Guangyong Ji, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3211, MSC 7808, Bethesda, MD 20892, 301-435-1146, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR-18-102: Small Grants for New Investigators to Promote Diversity in Health-Related Research (R21 Clinical Trial Optional).

    Date: November 16, 2018.

    Time: 8:00 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: Jianxin Hu, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 2156, Bethesda, MD 20892, 301-827-4417, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR Panel: Innovative Basic Research on Adducts in Cancer Risk Identification and Prevention.

    Date: November 16, 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 (Telephone Conference Call).

    Contact Person: Jeffrey Smiley, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6194, MSC 7804, Bethesda, MD 20892, 301-594-7945, [email protected].

    (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research; 93.306, 93.333, 93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893, National Institutes of Health, HHS)
    Dated: October 12, 2018. Sylvia L. Neal, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-22725 Filed 10-17-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Center for Complementary & Integrative Health; Notice of Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the Special Emphasis Panel.

    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 Center for Complementary and Integrative Health Special Emphasis Panel; Fellowship, Career Development, and Research Grant Programs.

    Date: November 30, 2018.

    Time: 10:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892 (Virtual Meeting).

    Contact Person: Viatcheslav A. Soldatenkov, MD, Ph.D., Scientific Review Officer, Office of Scientific Review, Division of Extramural Activities, NCCIH/NIH, 6707 Democracy Boulevard, Suite 401, Bethesda, MD 20892, [email protected].

    (Catalogue of Federal Domestic Assistance Program Nos. 93.213, Research and Training in Complementary and Integrative Health, National Institutes of Health, HHS)
    Dated: October 12, 2018. Ronald J. Livingston, Jr., Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-22679 Filed 10-17-18; 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 & Human Development; 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 Child Health and Human Development Special Emphasis Panel Member Conflict Special Emphasis Panel.

    Date: November 14, 2018.

    Time: 10:00 a.m. to 12:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6710B, Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call).

    Contact Person: Helen Huang, Scientific Review Branch (SRB), DER, Eunice Kennedy Shriver National Institute of Child Health and Human Development, NIH, DHHS, 6710B Rockledge Drive, Rm 2125B, Bethesda, MD 20817, 301-435-8380, [email protected].

    (Catalogue of Federal Domestic Assistance Program Nos. 93.864, Population Research; 93.865, Research for Mothers and Children; 93.929, Center for Medical Rehabilitation Research; 93.209, Contraception and Infertility Loan Repayment Program, National Institutes of Health, HHS)
    Dated: October 15, 2018. Ronald J. Livingston, Jr., Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-22723 Filed 10-17-18; 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; Notice of Meeting

    Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the National Advisory Board on Medical Rehabilitation Research.

    The meeting will be open to the public, 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.

    Name of Committee: National Advisory Board on Medical Rehabilitation Research.

    Date: December 3-4, 2018.

    Time: December 3, 2018, 9:00 a.m. to 5:00 p.m.

    Agenda: NICHD Director's report; NCMRR Updates; NCATS Support for Research Infrastructure; NIH Research Plan on Rehabilitation; NINDS Stroke Translation Research; Limb Loss Research.

    Place: NICHD Offices, 6710B Rockledge Drive, Rooms 1425/1427, Bethesda, MD 20892.

    Time: December 4, 2018, 8:30 a.m. to 12:00 p.m.

    Agenda: NIH BRAIN Initiative; Dissemination and Implementation Research; CDC: Health and Disability; Scientific Presentation on Activity and Participation.

    Place: NICHD Offices, 6710B Rockledge Drive, Rooms 1425/1427, Bethesda, MD 20892.

    Contact Person: Ralph M. Nitkin, Ph.D., Deputy Director, National Center for Medical Rehabilitation Research (NCMRR), Eunice Kennedy Shriver National Institute of Child Health and Human Development, NIH, DHHS, 6710B Rockledge Drive, Room 2116, MSC 7002, Bethesda, MD 20892, (301) 402-4206, [email protected].

    Information is also available on the Institute's/Center's home page: http://www.nichd.nih.gov/about/advisory/nabmrr/Pages/index.aspx where the current roster and minutes from past meetings are posted.

    The Board meeting will be videocast out to the public and will be archived for later viewing at: https://videocast.nih.gov/.

    (Catalogue of Federal Domestic Assistance Program Nos. 93.864, Population Research; 93.865, Research for Mothers and Children; 93.929, Center for Medical Rehabilitation Research; 93.209, Contraception and Infertility Loan Repayment Program, National Institutes of Health, HHS)
    Dated: October 15, 2018. Ronald J. Livingston, Jr., Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-22724 Filed 10-17-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Center for Complementary & Integrative Health; Notice of Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended notice is hereby given of a meeting of the Special Emphasis Panel.

    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 Center for Complementary and Integrative Health Special Emphasis Panel; Center of Excellence for Research on Complementary and Integrative Health (P01) (CERCIH).

    Date: November 27, 2018.

    Time: 12:00 p.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892 (Virtual Meeting).

    Contact Person: Ashlee Tipton, Ph.D., Scientific Review Officer, Division of Extramural Activities, National Center for Complementary and Integrative Health, 6707 Democracy Boulevard, Room 401, Bethesda, MD 20892, 301-451-3849, [email protected].

    (Catalogue of Federal Domestic Assistance Program Nos. 93.213, Research and Training in Complementary and Integrative Health, National Institutes of Health, HHS)
    Dated: October 12, 2018. Ronald J. Livingston, Jr., Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-22678 Filed 10-17-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard [Docket No. USCG-2018-0784] Collection of Information Under Review by Office of Management and Budget; OMB Control Number: 1625-0014 AGENCY:

    Coast Guard, DHS.

    ACTION:

    Thirty-day notice requesting comments.

    SUMMARY:

    In compliance with the Paperwork Reduction Act of 1995 the U.S. Coast Guard is forwarding an Information Collection Request (ICR), abstracted below, to the Office of Management and Budget (OMB), Office of Information and Regulatory Affairs (OIRA), requesting an extension of its approval for the following collection of information: 1625-0014, Request for Designation and Exemption of Oceanographic Research Vessels; without change. Our ICR describes the information we seek to collect from the public. Review and comments by OIRA ensure we only impose paperwork burdens commensurate with our performance of duties.

    DATES:

    Comments must reach the Coast Guard and OIRA on or before November 19, 2018.

    ADDRESSES:

    You may submit comments identified by Coast Guard docket number [USCG-2018-0784] to the Coast Guard using the Federal eRulemaking Portal at https://www.regulations.gov. Alternatively, you may submit comments to OIRA using one of the following means:

    (1) Email: [email protected]

    (2) Mail: OIRA, 725 17th Street NW, Washington, DC 20503, attention Desk Officer for the Coast Guard.

    A copy of the ICR is available through the docket on the internet at https://www.regulations.gov. Additionally, copies are available from: COMMANDANT (CG-612), ATTN: PAPERWORK REDUCTION ACT MANAGER, U.S. COAST GUARD, 2703 MARTIN LUTHER KING JR AVE SE, STOP 7710, WASHINGTON, DC 20593-7710.

    FOR FURTHER INFORMATION CONTACT:

    Contact Mr. Anthony Smith, Office of Information Management, telephone 202-475-3532, or fax 202-372-8405, for questions on these documents.

    SUPPLEMENTARY INFORMATION:

    Public Participation and Request for Comments

    This Notice relies on the authority of the Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to OIRA seeking the approval, extension, or renewal of a Coast Guard collection of information (Collection). The ICR contains information describing the Collection's purpose, the Collection's likely burden on the affected public, an explanation of the necessity of the Collection, and other important information describing the Collection. There is one ICR for each Collection.

    The Coast Guard invites comments on whether this ICR should be granted based on the Collection being necessary for the proper performance of Departmental functions. In particular, the Coast Guard would appreciate comments addressing: (1) The practical utility of the Collection; (2) the accuracy of the estimated burden of the Collection; (3) ways to enhance the quality, utility, and clarity of information subject to the Collection; and (4) ways to minimize the burden of the Collection on respondents, including the use of automated collection techniques or other forms of information technology. These comments will help OIRA determine whether to approve the ICR referred to in this Notice.

    We encourage you to respond to this request by submitting comments and related materials. Comments to Coast Guard or OIRA must contain the OMB Control Number of the ICR. They must also contain the docket number of this request, [USCG-2018-0784], and must be received by November 19, 2018.

    Submitting Comments

    We encourage you to submit comments through the Federal eRulemaking Portal at https://www.regulations.gov. If your material cannot be submitted using https://www.regulations.gov, contact the person in the FOR FURTHER INFORMATION CONTACT section of this document for alternate instructions. Documents mentioned in this notice, and all public comments, are in our online docket at https://www.regulations.gov and can be viewed by following that website's instructions. Additionally, if you go to the online docket and sign up for email alerts, you will be notified when comments are posted.

    We accept anonymous comments. All comments received will be posted without change to https://www.regulations.gov and will include any personal information you have provided. For more about privacy and the docket, you may review a Privacy Act notice regarding the Federal Docket Management System in the March 24, 2005, issue of the Federal Register (70 FR 15086).

    OIRA posts its decisions on ICRs online at https://www.reginfo.gov/public/do/PRAMain after the comment period for each ICR. An OMB Notice of Action on each ICR will become available via a hyperlink in the OMB Control Number: 1625-0014.

    Previous Request for Comments

    This request provides a 30-day comment period required by OIRA. The Coast Guard published the 60-day notice (83 FR 39769, August 10, 2018) required by 44 U.S.C. 3506(c)(2). That Notice elicited no comments. Accordingly, no changes have been made to the Collections.

    Information Collection Request

    Title: Request for Designation and Exemption of Oceanographic Research Vessels.

    OMB Control Number: 1625-0014.

    Summary: This collection requires submission of specific information about a vessel in order for the vessel to be designated as an Oceanographic Research Vessel (ORV).

    Need: Title 46 U.S.C. 2113 authorizes the Secretary of the Department of Homeland Security to exempt Oceanographic Research Vessels (ORV), by regulation, from provisions of Subtitle II, of Title 46, Shipping, of the United States Code, concerning maritime safety and seaman's welfare laws. This information is necessary to ensure a vessel qualifies for the designation of ORV under 46 CFR part 3 and 46 CFR part 14, subpart D.

    Forms: N/A.

    Respondents: Owners or operators of certain vessels.

    Frequency: On occasion.

    Hour Burden Estimate: The estimated burden has increased from 25 hours to 36 hours a year due to an increase in the estimated annual number of respondents.

    Authority:

    The Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended.

    Dated: October 11, 2018. James D. Roppel, U.S. Coast Guard, Acting Chief, Office of Information Management.
    [FR Doc. 2018-22690 Filed 10-17-18; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR-6131-N-01] The Performance Review Board AGENCY:

    Office of the Deputy Secretary, HUD.

    ACTION:

    Notice of appointments.

    SUMMARY:

    The Department of Housing and Urban Development announces the establishment of two Performance Review Boards to make recommendations to the appointing authority on the performance of its senior executives. Patricia Hoban-Moore, Felicia Purifoy, Danielle Bastarache, John Benison, Virginia Sardone, Bryan Greene, Ivery Himes, George Tomchick, and Kurt Usowski will serve as members of the Departmental Performance Review Board to review career SES performance. Seth D. Appleton, Maren Kasper, John Bravacos, Ralph Gaines, and Joseph Grassi will serve as members of the Departmental Performance Review Board to review noncareer SES performance. The address is: Department of Housing and Urban Development, Washington, DC 20410-0050.

    FOR FURTHER INFORMATION CONTACT:

    Persons desiring any further information about the Performance Review Board and its members may contact Lynette Warren, Director, Office of Executive Resources, Department of Housing and Urban Development, Washington, DC 20410. Telephone (202) 708-1381. (This is not a toll-free number)

    Dated: October 11, 2018. Pamela H. Patenaude, Deputy Secretary.
    [FR Doc. 2018-22733 Filed 10-17-18; 8:45 am] BILLING CODE P
    INTERNATIONAL TRADE COMMISSION [USITC SE-18-047] Government in the Sunshine Act Meeting Notice

    Agency Holding the Meeting:

    United States International Trade Commission.

    Time and Date:

    October 23, 2018 at 11:00 a.m.

    Place:

    Room 101, 500 E Street SW, Washington, DC 20436, Telephone: (202) 205-2000.

    Status:

    Open to the public.

    Matters to be Considered:

    1. Agendas for future meetings: None.

    2. Minutes.

    3. Ratification List.

    4. Vote on Inv. No. 731-TA-1203 (Review) (Xanthan Gum from China). The Commission is currently scheduled to complete and file its determination and views of the Commission by November 15, 2018.

    5. Vote on Inv. Nos. 731-TA-873-875, 878-880, and 882 (Third Review) (Steel Concrete Reinforcing Bar from Belarus, China, Indonesia, Latvia, Moldova, Poland, and Ukraine). The Commission is currently scheduled to complete and file its determinations and views of the Commission by November 15, 2018.

    6. Outstanding action jackets: None.

    In accordance with Commission policy, subject matter listed above, not disposed of at the scheduled meeting, may be carried over to the agenda of the following meeting.

    By order of the Commission:

    Issued: October 15, 2018. William Bishop, Supervisory Hearings and Information Officer.
    [FR Doc. 2018-22798 Filed 10-16-18; 11:15 am] BILLING CODE 7020-02-P
    MERIT SYSTEMS PROTECTION BOARD Membership of the Merit Systems Protection Board's Performance Review Board AGENCY:

    Merit Systems Protection Board.

    ACTION:

    Notice.

    SUMMARY:

    Notice is hereby given of the members of the Merit Systems Protection Board's Performance Review Board.

    DATES:

    October 18, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Pervis Lee, Director of Human Resources, Merit Systems Protection Board, 1615 M Street NW, Washington, DC 20419; telephone: (202) 254-4413; or email: [email protected]

    SUPPLEMENTARY INFORMATION:

    The Merit Systems Protection Board is publishing the names of the current members of the Performance Review Board (PRB) as required by 5 U.S.C. 4314(c)(4). Laura M. Albornoz serves as Chair of the PRB. Louis Lopez, Office of Special Counsel, Susan M. Swafford, Merit Systems Protection Board, and William L. Boulden, Merit Systems Protection Board, serve as members of the PRB.

    Jennifer Everling, Acting Clerk of the Board.
    [FR Doc. 2018-22668 Filed 10-17-18; 8:45 am] BILLING CODE 7400-01-P
    MILLENNIUM CHALLENGE CORPORATION [MCC FR 18-13] Notice of Open Meeting AGENCY:

    Millennium Challenge Corporation.

    ACTION:

    Notice.

    SUMMARY:

    In accordance with the requirements of the Federal Advisory Committee Act, 5 U.S.C. App., the Millennium Challenge Corporation (MCC) Advisory Council was established as a discretionary advisory committee on July 14, 2016. Its charter was renewed for a second term on July 11, 2018. The MCC Advisory Council serves MCC in a solely advisory capacity and provides insight regarding innovations in infrastructure, technology and sustainability; perceived risks and opportunities in MCC partner countries; new financing mechanisms for developing country contexts; and shared value approaches. The MCC Advisory Council provides a platform for systematic engagement with the private sector and other external stakeholders and contributes to MCC's mission—to reduce poverty through sustainable, economic growth.

    DATES:

    Monday, November 5, 2018, from 9:00 a.m.-2:00 p.m. EST which includes a working lunch.

    ADDRESSES:

    The meeting will be held at the Millennium Challenge Corporation, 1099 14th Street NW, Suite 700, Washington, DC 20005.

    FOR FURTHER INFORMATION CONTACT:

    Carisa Graf-Suleman, 202.766.0286, [email protected] or visit https://www.mcc.gov/about/org-unit/advisory-council.

    SUPPLEMENTARY INFORMATION:

    Agenda. During the Fall/Winter 2018 meeting of the MCC Advisory Council, members will be provided an overview and update of MCC's work and discuss with MCC leadership the MCC selection process. The MCC Advisory Council will also provide advice on the compact development process and MCC's investment strategy in Sri Lanka. A guest speaker will discuss the changing development finance landscape with the MCC Advisory Council.

    Public Participation. The meeting will be open to the public. Members of the public may file written statement(s) before or after the meeting. If you plan to attend, please submit your name and affiliation no later than Monday, October 29, 2018 to [email protected] to be placed on an attendee list.

    Dated: October 15, 2018. Jeanne M. Hauch, VP/General Counsel and Corporate Secretary.
    [FR Doc. 2018-22740 Filed 10-17-18; 8:45 am] BILLING CODE 9211-03-P
    NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (18-078)] Notice of Intent To Grant Partially Exclusive License AGENCY:

    National Aeronautics and Space Administration.

    ACTION:

    Notice of intent to grant partially exclusive license.

    SUMMARY:

    NASA hereby gives notice of its intent to grant a partially exclusive license in the United States to practice the invention described and claimed in U.S. Patent Application Serial No. 62/555,416 entitled “Real-Time Six Degree of Freedom Shape Sensing Algorithm”, to Safety Technology Holding, Inc., having its principal place of business in Plymouth, MI. The fields of use may be limited to anthropomorphic dummies used in the automotive testing industry. NASA has not yet made a determination to grant the requested license and may deny the requested license even if no objections are submitted within the comment period.

    DATES:

    The prospective partially exclusive term license may be granted unless NASA receives written objections, including evidence and argument no later than November 2, 2018 that establish that the grant of the license would not be consistent with the requirements regarding the licensing of federally owned inventions as set forth in the Bayh-Dole Act and implementing regulations. Competing applications completed and received by NASA no later than November 2, 2018 will also be treated as objections to the grant of the contemplated exclusive license. Objections submitted in response to this notice will not be made available to the public for inspection and, to the extent permitted by law, will not be released under the Freedom of Information Act.

    ADDRESSES:

    Objections relating to the prospective license may be submitted to Mr. Mark Homer, Patent Counsel, Jet Propulsion Laboratory, 4800 Oak Grove Drive, M/S 180-800, Pasadena, CA 91109, (818) 354-7770.

    FOR FURTHER INFORMATION CONTACT:

    Ms. Janeya Griffin, Technology Transfer Branch, Armstrong Flight Research Center, 4800 Lilly Drive M/S 1100 Edwards, California 93524, (661) 276-5743.

    SUPPLEMENTARY INFORMATION:

    This notice of intent to grant an exclusive patent license is issued in accordance with 35 U.S.C. 209(e) and 37 CFR 404.7(a)(1)(i). The patent rights in these inventions have been assigned to the United States of America as represented by the Administrator of the National Aeronautics and Space Administration. The prospective partially exclusive license will comply with the requirements of 35 U.S.C. 209 and 37 CFR 404.7.

    Information about other NASA inventions available for licensing can be found online at http://technology.nasa.gov.

    Mark Dvorscak, Agency Counsel for Intellectual Property.
    [FR Doc. 2018-22669 Filed 10-17-18; 8:45 am] BILLING CODE 7510-13-P
    NATIONAL CREDIT UNION ADMINISTRATION Sunshine Act; Notice of Matters To Be Deleted From the Agenda of a Previously Announced Agency Meeting FEDERAL REGISTER CITATION OF PREVIOUS ANNOUNCEMENT:

    October 15, 2018 (83 FR 51986).

    TIME AND DATE:

    9:00 a.m., Thursday, October 18, 2018.

    PLACE:

    Board Room, 7th Floor, Room 7047, 1775 Duke Street, Alexandria, VA 22314-3428.

    STATUS:

    Closed.

    Pursuant to the provisions of the “Government in Sunshine Act” notice is hereby given that the NCUA Board gave notice on October 11, 2018 of the regular meeting of the NCUA Board scheduled for October 18, 2018. Prior to the meeting, on October 16, 2018, the NCUA Board unanimously determined that agency business required the deletion of the first and second items on the closed agenda with less than seven days' notice to the public, and that no earlier notice of the deletion was possible.

    MATTERS TO BE DELETED:

    1. Supervisory Enforcement Matter. Closed pursuant to Exemptions (6), (8), (9)(ii), and (10).

    2. Supervisory Enforcement Matter. Closed pursuant to Exemptions (6), (8), (9)(ii), and (10).

    FOR FURTHER INFORMATION CONTACT:

    Gerard Poliquin, Secretary of the Board, Telephone: 703-518-6304.

    Gerard Poliquin, Secretary of the Board.
    [FR Doc. 2018-22847 Filed 10-16-18; 4:15 pm] BILLING CODE 7535-01-P
    NATIONAL FOUNDATION ON THE ARTS AND THE HUMANITIES Institute of Museum and Library Services Submission for OMB Review, Comment Request, Proposed Collection: IMLS Accelerating Promising Practices for Small Libraries (APP) Notice of Funding Opportunity AGENCY:

    Institute of Museum and Library Services, National Foundation on the Arts and the Humanities.

    ACTION:

    Submission for OMB review, comment request.

    SUMMARY:

    The Institute of Museum and Library Services announces the following information collection has been submitted to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. This notice proposes the clearance of the instructions for the IMLS Accelerating Promising Practices for Small Libraries (APP) Notice of Funding Opportunity.

    A copy of the proposed information collection request can be obtained by contacting the individual listed below in the ADDRESSES section of this notice.

    DATES:

    Comments must be submitted to the office listed in the CONTACT section below on or before November 16, 2018.

    OMB is particularly interested in comments that help the agency to:

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

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

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

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

    ADDRESSES:

    Comments should be sent to Office of Information and Regulatory Affairs, Attn.: OMB Desk Officer for Education, Office of Management and Budget, Room 10235, Washington, DC 20503, (202) 395-7316.

    FOR FURTHER INFORMATION CONTACT:

    Dr. Sandra Webb, Director of Grant Policy and Management, Institute of Museum and Library Services, 955 L'Enfant Plaza North, SW, Suite 4000, Washington, DC 20024-2135. Dr. Webb can be reached by Telephone: 202-653-4718 Fax: 202-653-4608, or by email at [email protected], or by teletype (TTY/TDD) for persons with hearing difficulty at 202-653-4614.

    SUPPLEMENTARY INFORMATION:

    I. Background

    The Institute of Museum and Library Services is the primary source of federal support for the nation's libraries and museums. We advance, support, and empower America's museums, libraries, and related organizations through grant making, research, and policy development. Our vision is a nation where museums and libraries work together to transform the lives of individuals and communities. To learn more, visit www.imls.gov.

    II. Current Actions

    The goal of the IMLS initiative Accelerating Promising Practices for Small Libraries (APP) is to support projects that strengthen the ability of small and rural libraries and archives to serve their communities. IMLS invites applications that focus on transforming school library practice, community memory, or digital inclusion, and are clearly linked to an individual institution's broader community needs. IMLS Accelerating Promising Practices for Small Libraries (APPL) is being offered as a special initiative with funding from the National Leadership Grants for Libraries Program. This action is to create the forms and instructions for this initiative as a Notice of Funding Opportunity for the next three years.

    Agency: Institute of Museum and Library Services.

    Title: 2019-2021 IMLS Accelerating Promising Practices for Small Libraries Notice of Funding Opportunity.

    OMB Number: 3137-TBD.

    Frequency: Once per year.

    Affected Public: Library organization applicants.

    Number of Respondents: 150.

    Estimated Average Burden per Response: 35 hours.

    Estimated Total Annual Burden: 5250 hours.

    Total Annualized capital/startup costs: n/a.

    Total Annual costs: $145,582.50.

    Dated: October 15, 2018. Kim Miller, Grants Management Specialist, Institute of Museum and Library Services.
    [FR Doc. 2018-22737 Filed 10-17-18; 8:45 am] BILLING CODE 7036-01-P
    NATIONAL FOUNDATION ON THE ARTS AND THE HUMANITIES National Endowment for the Arts 30-Day Notice for the “Our Town Program Implementation Study” Proposed Collection; Comment Request AGENCY:

    National Endowment for the Arts, National Foundation on the Arts and the Humanities.

    ACTION:

    Notice.

    SUMMARY:

    The National Endowment for the Arts (NEA), as part of its continuing effort to reduce paperwork and respondent burden, conducts a preclearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995. This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. Currently, the NEA is soliciting comments concerning the proposed information collection for the Evaluation of the Our Town Program. A copy of the current information collection request can be obtained by contacting the office listed below in the address section of this notice.

    DATES:

    Written comments must be submitted to the office listed in the address section below within 30 days from the date of this publication in the Federal Register.

    ADDRESSES:

    Send comments to: Sunil Iyengar, National Endowment for the Arts, 400 7th Street SW, Washington, DC 20506-0001, telephone (202) 682-5424 (this is not a toll-free number), fax (202) 682-5677, or send via email to [email protected].

    FOR FURTHER INFORMATION CONTACT:

    The Office of Information and Regulatory Affairs, Attn: Sharon Mar, OMB Desk Officer for the National Endowment for the Arts, Office of Management and Budget, Room 10235, Washington, DC 20503, 202-395-7316.

    SUPPLEMENTARY INFORMATION:

    The NEA is particularly interested in comments which:

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

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

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

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

    Agency: National Endowment for the Arts.

    Title: Our Town Program Implementation Study.

    OMB Number: New.

    Frequency: One Time.

    Affected Public: Grantee Organizations (local government agencies and nonprofits).

    Estimated Number of Respondents: 381.

    Total burden hours: 190.5 hours.

    Total annualized capital/startup costs: 0.

    Total annual costs (operating/maintaining systems or purchasing services): $55,000.

    This study is a new information collection request, and the data to be collected are not available elsewhere unless obtained through this information collection. A web-based survey of the National Endowment for the Arts' (NEA) Our Town program grantees is planned for late January 2019 through mid-April 2019. Knowledge gained through this study will enable the NEA to validate or modify the Our Town program theory of change, logic model, and measurement model in order to adjust grant program guidelines and grantee reporting requirements and to prepare for a future outcome evaluation study. The web-based survey of past and present Our Town grantees will provide the NEA with a richer understanding of how Our Town grantees operate in local communities and the types of change to which the grants contribute. Currently, the NEA grantee report form does not collect detailed information about project design, and changes to the report form would not yield substantive information until at least 2022 due to the grant reporting cycle. Our Town is the NEA's creative placemaking grants program since FY 2011. Through project-based funding ranging from $25,000 to $150,000, the agency makes awards nationally to local government agencies and nonprofit organizations in urban, rural, and tribal communities to support projects that integrate arts, culture, and design activities into efforts that strengthen communities by advancing local economic, physical, and/or social outcomes. These projects require a partnership between a local government entity and nonprofit organization, one of which must be a cultural organization; and should engage in partnership with other sectors (such as agriculture and food, economic development, education and youth, environment and energy, health, housing, public safety, transportation, and workforce development). Our Town projects proposed by applicants often utilize a mix of activities, including arts engagement, cultural planning, design, and artist and creative industry support. It is the agency's vision that successful Our Town projects ultimately lay the groundwork for systemic changes that sustain the integration of arts, culture, and design into strategies for strengthening communities. This study supports NEA's FY 2018-2022 Strategic Plan, which seeks in part to “provide opportunities for the arts to be integrated into the fabric of community life” (Strategic Objective 2.3) and to “expand and promote evidence of the value and impact of the arts for the benefit of the American people” (Strategic Objective 3.2).

    Dated: October 15, 2018. Gregory Gendron, Director, Administrative Services, National Endowment for the Arts.
    [FR Doc. 2018-22729 Filed 10-17-18; 8:45 am] BILLING CODE 7537-01-P
    OCCUPATIONAL SAFETY AND HEALTH REVIEW COMMISSION Privacy Act of 1974; System of Records AGENCY:

    Occupational Safety and Health Review Commission.

    ACTION:

    Notice of a modified system of records and rescindment of a system of records notice.

    SUMMARY:

    In accordance with the Privacy Act of 1974, as amended, the Occupational Safety and Health Review Commission (OSHRC) is revising the notice for system-of-records OSHRC-7 and is rescinding the notice for system-of-records OSHRC-8.

    DATES:

    Comments must be received by OSHRC on or before November 19, 2018. The revisions to the system-of-records notice for OSHRC-7, and the rescindment of the notice for OSHRC-8, will become effective on that date, without any further notice in the Federal Register, unless comments or government approval procedures necessitate otherwise.

    ADDRESSES:

    You may submit comments by any of the following methods:

    Email: [email protected] Include “PRIVACY ACT SYSTEM OF RECORDS” in the subject line of the message.

    Fax: (202) 606-5417.

    Mail: One Lafayette Centre, 1120 20th Street NW, Ninth Floor, Washington, DC 20036-3457.

    Hand Delivery/Courier: Same as mailing address.

    Instructions: All submissions must include your name, return address, and email address, if applicable. Please clearly label submissions as “PRIVACY ACT SYSTEM OF RECORDS.”

    FOR FURTHER INFORMATION CONTACT:

    Ron Bailey, Attorney-Advisor, Office of the General Counsel, via telephone at (202) 606-5410, or via email at [email protected]

    SUPPLEMENTARY INFORMATION:

    The Privacy Act of 1974, 5 U.S.C. 552a(e)(4), requires federal agencies such as OSHRC to publish in the Federal Register notice of any new or modified system of records. As detailed below, OSHRC is revising the notice for Personnel Security Files, OSHRC-7, to (1) account for changes in the names of the pertinent office and positions within the agency; (2) eliminate OSHRC's regional offices as system locations and managers; (3) revise the method by which records are retrieved; (4) update the authorities permitting maintenance of this system of records and the reference to the applicable General Records Schedule; (5) simplify the explanations concerning the categories of individuals covered by the system, and the categories of records in the system; and (6) accurately describe storage and safeguarding practices. To this system, OSHRC is also adding records relating to the issuance of office access cards, which are retrievable by name, and include the first and last names of those issued cards, and the dates that the cards were activated, deactivated, and turned in. In addition, OSHRC has previously relied on blanket routine uses to describe the circumstances under which records may be disclosed. Going forward, as revised notices are published for new and modified systems of records, a full description of the routine uses—rather than a reference to blanket routine uses—will be included in each notice. This is simply a change in format that has not resulted in any substantive changes to the routine uses for this system of records.

    OSHRC is also rescinding the notice for OSHRC-8—Identification Card and Office Key Distribution Records. Most of the records covered by OSHRC-8 are no longer maintained by OSHRC due to the issuance and use of personal identity verification (PIV) cards, in accordance with Homeland Security Presidential Directive (HSPD) 12. Records concerning these PIV cards are maintained by the General Services Administration (GSA) and are covered by the governmentwide system-of-records notice GSA/GOVT-7 (HSPD-12 USAccess). OSHRC does, however, maintain records, as described above, on office access cards. OSHRC has concluded, however, that such records are related to personnel security and therefore should be included in OSHRC-7, Personnel Security Records.

    The notices for the rescission of OSHRC-8, and for modified system-of-records OSHRC-7, are as follows.

    SYSTEM NAME AND NUMBER

    Identification Card and Office Key Distribution Records, OSHRC-8.

    HISTORY:

    April 14, 2006, 71 FR 19556; August 4, 2008, 73 FR 45256; October 5, 2015, 80 FR 60182; and September 28, 2017, 82 FR 45324.

    SYSTEM NAME AND NUMBER:

    Personnel Security Records, OSHRC-7.

    SECURITY CLASSIFICATION:

    Unclassified.

    SYSTEM LOCATION:

    The Office of the Executive Director maintains the records in this system. The office is located at 1120 20th Street NW, Ninth Floor, Washington, DC 20036-3457.

    SYSTEM MANAGER(S):

    Human Resources Specialist, 1120 20th Street NW, Ninth Floor, Washington, DC 20036-3457; (202) 606-5100.

    AUTHORITY FOR MAINTENANCE OF THE SYSTEM:

    Executive Orders 10450, 10577, 13467, and 13488; Homeland Security Presidential Directive (HSPD) 12; and Federal Information Processing Standard (FIPS) 201.

    PURPOSE(S) OF THE SYSTEM:

    The information collected by OSHRC allows the Office of Personnel Management (OPM) to conduct background investigations on those individuals being credentialed, assists in verifying the identity of those for whom credentials have been requested, and provides the necessary information for issuance of identification and access cards.

    CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:

    This system of records covers current OSHRC employees, contractors, and Commission members, and, as to records concerning office access cards, also former employees, contractors, and Commission members.

    CATEGORIES OF RECORDS IN THE SYSTEM:

    This system of records may include an individual's name and former names; signature; date and place of birth; social security number; citizenship information; residential history; education; employment history; criminal history and police records; names of associates and references, and their contact information; military history and selective service record; illegal drug activities; telephone numbers; hair and eye color, weight, and height; gender; financial records; investigative records; foreign countries visited; marital status and name, date and place of birth, address, and social security number of spouse; names of certain relatives who work for the government; names, addresses, dates and countries of birth, and citizenship of certain relatives. As to office access cards, the records include only the individual's name, and the date that the access card was activated, deactivated, and turned in.

    Most of these records are decentralized copies from OPM and remain subject to the practices and policies set forth in system-of-records notice OPM/CENTRAL-9 (Personnel Investigations Records).

    RECORD SOURCE CATEGORIES:

    Information contained in the system is obtained from individuals subject to the credentialing process, OSHRC employees involved in the credentialing process, and investigative record materials furnished by OPM.

    ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES OF USERS AND PURPOSES OF SUCH USES:

    In addition to disclosures generally permitted under 5 U.S.C. 552a(b), all or a portion of the records or information contained in this system of records may be disclosed as a routine use pursuant to 5 U.S.C. 552a(b)(3) under the circumstances or for the purposes described below, to the extent such disclosures are compatible with the purposes for which the information was collected:

    (1) To the Department of Justice (DOJ), or to a court or adjudicative body before which OSHRC is authorized to appear, when any of the following entities or individuals—(a) OSHRC, or any of its components; (b) any employee of OSHRC in his or her official capacity; (c) any employee of OSHRC in his or her individual capacity where DOJ (or OSHRC where it is authorized to do so) has agreed to represent the employee; or (d) the United States, where OSHRC determines that litigation is likely to affect OSHRC or any of its components—is a party to litigation or has an interest in such litigation, and OSHRC determines that the use of such records by DOJ, or by a court or other tribunal, or another party before such tribunal, is relevant and necessary to the litigation.

    (2) To an appropriate agency, whether federal, state, local, or foreign, charged with investigating or prosecuting a violation or enforcing or implementing a law, rule, regulation, or order, when a record, either on its face or in conjunction with other information, indicates a violation or potential violation of law, which includes civil, criminal or regulatory violations, and such disclosure is proper and consistent with the official duties of the person making the disclosure.

    (3) To a federal, state, or local agency maintaining civil, criminal or other relevant enforcement information, such as current licenses, if necessary to obtain information relevant to an OSHRC decision concerning the hiring, appointment, or retention of an employee; the issuance, renewal, suspension, or revocation of a security clearance; the execution of a security or suitability investigation; the letting of a contract; or the issuance of a license, grant or other benefit.

    (4) To a federal, state, or local agency, in response to that agency's request for a record, and only to the extent that the information is relevant and necessary to the requesting agency's decision in the matter, if the record is sought in connection with the hiring, appointment, or retention of an employee; the issuance, renewal, suspension, or revocation of a security clearance; the execution of a security or suitability investigation; the letting of a contract; or the issuance of a license, grant or other benefit by the requesting agency.

    (5) To an authorized appeal grievance examiner, formal complaints manager, equal employment opportunity investigator, arbitrator, or other duly authorized official engaged in investigation or settlement of a grievance, complaint, or appeal filed by an employee, only to the extent that the information is relevant and necessary to the case or matter.

    (6) To OPM in accordance with the agency's responsibilities for evaluation and oversight of federal personnel management.

    (7) To officers and employees of a federal agency for the purpose of conducting an audit, but only to the extent that the record is relevant and necessary to this purpose.

    (8) To OMB in connection with the review of private relief legislation at any stage of the legislative coordination and clearance process, as set forth in Circular No. A-19.

    (9) To a Member of Congress or to a person on his or her staff acting on the Member's behalf when a written request is made on behalf and at the behest of the individual who is the subject of the record.

    (10) To the National Archives and Records Administration (NARA) for records management inspections and such other purposes conducted under the authority of 44 U.S.C. 2904 and 2906.

    (11) To appropriate agencies, entities, and persons when: (a) OSHRC suspects or has confirmed that there has been a breach of the system of records; (b) OSHRC has determined that as a result of the suspected or confirmed breach there is a risk of harm to individuals, OSHRC, the Federal Government, or national security; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with OSHRC's efforts to respond to the suspected or confirmed breach or to prevent, minimize, or remedy such harm.

    (12) To NARA, Office of Government Information Services (OGIS), to the extent necessary to fulfill its responsibilities in 5 U.S.C. 552(h), to review administrative agency policies, procedures and compliance with FOIA, and to facilitate OGIS' offering of mediation services to resolve disputes between persons making FOIA requests and administrative agencies.

    (13) To another federal agency or federal entity, when OSHRC determines that information from this system of records is reasonably necessary to assist the recipient agency or entity in (a) responding to a suspected or confirmed breach or (b) preventing, minimizing, or remedying the risk of harm to individuals, the recipient agency or entity (including its information systems, programs, and operations), the Federal Government, or national security, resulting from a suspected or confirmed breach.

    POLICIES AND PRACTICES FOR STORAGE OF RECORDS:

    Records are stored on paper in locked file cabinets.

    POLICIES AND PRACTICES FOR RETRIEVAL OF RECORDS:

    Records are retrieved by an individual's name.

    POLICIES AND PRACTICES FOR RETENTION AND DISPOSAL OF RECORDS:

    Office access card records are retained and disposed of in accordance with NARA's General Records Schedule 5.6, Item 21. However, paper copies of personnel security records from OPM are shredded once an employee, contractor, or Commission member no longer works at OSHRC.

    ADMINISTRATIVE, TECHNICAL, AND PHYSICAL SAFEGUARDS:

    Records are maintained in a locked file cabinet. Access to the cabinet is limited to personnel having a need for access to perform their official functions.

    RECORD ACCESS PROCEDURES:

    Individuals who wish to gain access to their records should notify: Privacy Officer, OSHRC, 1120 20th Street NW, Ninth Floor, Washington, DC 20036-3457. For an explanation on how such requests should be drafted, refer to 29 CFR 2400.6 (procedures for requesting records).

    CONTESTING RECORD PROCEDURES:

    Individuals who wish to contest their records should notify: Privacy Officer, OSHRC, 1120 20th Street NW, Ninth Floor, Washington, DC 20036-3457. For an explanation on the specific procedures for contesting the contents of a record, refer to 29 CFR 2400.8 (Procedures for requesting amendment), and 29 CFR 2400.9 (Procedures for appealing).

    NOTIFICATION PROCEDURES:

    Individuals interested in inquiring about their records should notify: Privacy Officer, OSHRC, 1120 20th Street NW, Ninth Floor, Washington, DC 20036-3457. For an explanation on how such requests should be drafted, refer to 29 CFR 2400.5 (notification), and 29 CFR 2400.6 (procedures for requesting records).

    EXEMPTIONS PROMULGATED FOR THE SYSTEM:

    None.

    HISTORY:

    April 14, 2006, 71 FR 19556; August 4, 2008, 73 FR 45256; October 5, 2015, 80 FR 60182; and September 28, 2017, 82 FR 45324.

    Dated: October 11, 2018. Nadine N. Mancini, General Counsel, Senior Agency Official for Privacy.
    [FR Doc. 2018-22677 Filed 10-17-18; 8:45 am] BILLING CODE 7600-01-P
    SECURITIES AND EXCHANGE COMMISSION [Release No. 34-84420; File No. SR-NYSE-2018-46] Self-Regulatory Organizations; New York Stock Exchange LLC; Notice of Filing of Proposed Rule Change To Amend the Listed Company Manual for Acquisition Companies To Reduce the Continued Listing Standards for Public Holders From 300 to 100 and To Enable the Exchange To Exercise Discretion To Allow Acquisition Companies a Reasonable Time Period Following a Business Combination To Demonstrate Compliance With the Applicable Quantitative Listing Standards October 12, 2018.

    Pursuant to Section 19(b)(1) 1 of the Securities Exchange Act of 1934 (“Act”) 2 and Rule 19b-4 thereunder,3 notice is hereby given that, on October 1, 2018, New York Stock Exchange LLC (“NYSE” 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 self-regulatory organization. The Commission is publishing this notice to solicit comments on the proposed rule change from interested persons.

    1 15 U.S.C. 78s(b)(1).

    2 15 U.S.C. 78a.

    3 17 CFR 240.19b-4.

    I. Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change

    The Exchange proposes to proposes to amend the Listed Company Manual (the “Manual”) to revise its continued listing standards for Acquisition Companies..[sic] The proposed rule change is available on the Exchange's website at www.nyse.com, at the principal office of the Exchange, and at the Commission's Public Reference Room.

    II. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of those statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant parts of such statements.

    A. Self-Regulatory Organization's Statement of the Purpose of, and the Statutory Basis for, the Proposed Rule Change 1. Purpose

    Section 102.06 of the Manual sets forth initial listing requirements applicable to a company whose business plan is to complete an initial public offering and engage in a merger or acquisition with one or more unidentified companies within a specific period of time (an “Acquisition Company” or “AC”).4 Section 102.06 requires, in part, that an Acquisition Company: (i) Deposit into and retain in an escrow account at least 90% of the gross proceeds of its initial public offering through the date of its Business Combination; (ii) complete the Business Combination within 36 months of the effectiveness of the IPO registration statement; and (iii) provide the public shareholders who object to the Business Combination with the right to convert their common stock into a pro rata share of the funds held in escrow.5 Following the Business Combination, the combined company must meet the Exchange's requirements for initial listing.

    4 Section 102.06 provides that an Acquisition Company must complete one or more business combinations having an aggregate fair market value of at least 80% of the value of the deposit account (the “Business Combination”) within 36 months of the effectiveness of its IPO registration statement.

    5 Section 102.06 also requires that each proposed business combination be approved by a majority of the company's independent directors.

    Section 802.01B of the Manual sets forth the continued listing standards for ACs. The Exchange proposes to change its initial and continued listing standards for Acquisition Companies as follows:

    • Reduce the 300 total [sic] holders continued listing requirement to 100 total [sic] holders.

    • Amend the rule text in Section 802.01B to enable the Exchange to exercise discretion to allow companies a reasonable period of time following the Business Combination to demonstrate compliance with all applicable quantitative listing standards.

    Proposal To Reduce Continued Listing Requirement With Respect to Number of Holders

    Acquisition Companies often have difficulty demonstrating compliance with the 300 total [sic] shareholder requirement for continued listing. The shareholder requirement is designed to help ensure that a security has a sufficient number of investors to provide a liquid trading market.6 Based on conversations with marketplace participants, including the sponsors of Acquisition Companies and lawyers and bankers that advise these companies, the Exchange believes that the difficulties Acquisition Companies have in demonstrating compliance with the shareholder requirement are due to intrinsic features of Acquisition Companies, which limit the number of retail investors interested in the vehicle and encourage owners to hold their shares until a transaction is announced, which can be as long as three years after the initial public offering. These same intrinsic features of Acquisition Companies also limit the benefit to investors of a shareholder requirement.

    6See, e.g., Rocky Mountain Power Company, Securities Exchange Act Release No, 40648 (November 9, 1998) (text at footnote 11).

    In addition, because the price of an Acquisition Company is based primarily on the value of the funds it holds in trust, and the Acquisition Company's shareholders have the right to redeem their shares for a pro rata share of that trust in conjunction with the Business Combination, the impact of the number of shareholders on an Acquisition Company security's price is less relevant than is the case for operating company common stocks. For this reason, Acquisition Companies, historically, trade close to the value in the trust, even when they have had few shareholders. These trading patterns suggest that Acquisition Companies' low number of shareholders has not resulted in distorted prices.

    The Exchange believes that an Exchange Traded Fund (“ETF”) is somewhat similar to an Acquisition Company in this regard in that an arbitrage mechanism keeps the ETF's price close to the value of its underlying securities, even when trading in the ETF's shares is relatively illiquid. The initial listing requirements for ETFs do not include a shareholder requirement and only 50 shareholders are required for continued listing after the ETF has been listed for one year.

    Accordingly, given the short life of an Acquisition Company, the trading characteristics of Acquisition Companies, and the requirement to meet the initial listing standards at the time of the Business Combination, the Exchange proposes to reduce from 300 holders to 100 holders the minimum total number of [sic] holders required on a continued listing basis for Acquisition Companies.7

    7 The Exchange notes that any Acquisition Company listed on the NYSE will be allocated to a Designated Market Maker. As a result, the Exchange does not expect that the proposed change will result in illiquidity or other problems trading the securities of Acquisition Companies.

    Period for Company To Demonstrate That It Satisfies Initial Listing Requirements

    Section 802.01B of the Manual currently states that:

    After consummation of its Business Combination, a company that had originally listed as an AC will be subject to Section 801 and Section 802.01 in its entirety and will be required immediately upon consummation of the Business Combination to meet the following requirements:

    (i) A price per share of at least $4.00;

    (ii) a global market capitalization of at least $150,000,000;

    (iii) an aggregate market value of publicly-held shares of at least $40,000,000 *; and

    (iv) the requirements with respect to shareholders and publicly-held shares set forth in Section 102.01A for companies listing in connection with an initial public offering.8

    8 The applicable requirement is 400 holders of round lots (i.e., 100 shares).

    * Shares held by directors, officers, or their immediate families and other concentrated holding of 10 percent or more are excluded in calculating the number of publicly-held shares.

    Section 802.01B also provides that an Acquisition Company failing to meet these requirements will be promptly subject to suspension and delisting proceedings.

    The Exchange notes that it can be difficult for a company, once listed, to obtain evidence demonstrating the number of its shareholders because many accounts are held in street name and shareholders may object to being identified to the company. As a result, companies must seek information from broker-dealers and from third-parties that distribute information such as proxy materials for the broker-dealers. This process is especially burdensome for Acquisition Companies at the time of their Business Combinations, because Acquisition Company shareholders typically have the right to request redemption of their securities until immediately before consummation and it is therefore impracticable for companies to identify the number of round-lot holders immediately to demonstrate their qualification for initial listing.

    The Exchange proposes to amend Section 802.01B to provide that “[f]ollowing consummation of its Business Combination, a company that had originally listed as an [Acquisition Company] will be subject to” the quantitative listing standards set forth above. This change is consistent with rule text in Nasdaq's IM-5101-2 and is intended in particular to address the delays described above associated with obtaining information about the number of shareholders holding shares in “street name” accounts. By amending Section 802.01B, an Acquisition Company would not need to meet the shareholder distribution requirements immediately upon consummation of it Business Combination, but may do so at some point following closing of that transaction. The purpose of the proposed amendment is to allow the Exchange to exercise discretion to allow companies a reasonable period of time following the Business Combination to demonstrate compliance with the applicable quantitative listing standards, including the shareholders requirement. If the company is unable to demonstrate that it meets the applicable quantitative requirements after such reasonable time period, the Exchange would commence delisting proceedings and immediately suspend trading in the company's securities.

    These proposed changes will be effective upon approval of this rule by the Commission.

    2. Statutory Basis

    The Exchange believes that the proposed rule change is consistent with Section 6(b) of the Exchange Act,9 in general, and furthers the objectives of Section 6(b)(5) of the Exchange Act,10 in particular in that it is designed to promote just and equitable principles of trade, to foster cooperation and coordination with persons engaged in regulating, clearing, settling, processing information with respect to, and facilitating transactions in securities, to remove impediments to and perfect the mechanism of a free and open market and a national market system, and, in general, to protect investors and the public interest and is not designed to permit unfair discrimination between customers, issuers, brokers, or dealers. While the change would allow Acquisition Companies to maintain their continued listing status with fewer shareholders, this proposed change is consistent with the investor protection provisions of the Act because other protections help assure that market prices will not be distorted by any potential resulting lack of liquidity, which is the underlying purpose of the shareholder requirement. In particular, the ability of a shareholder to redeem shares for a pro rata share of the trust helps assure that the Acquisition Company will trade close to the value of the assets held in trust.

    9 15 U.S.C. 78f(b).

    10 15 U.S.C. 78f(b)(5).

    Thus, this change will remove impediments to and perfect the mechanism of a free and open market by removing listing requirements that prohibit certain companies from remaining listed without any concomitant investor protection benefits.

    The proposal to allow Acquisition Companies to demonstrate that they meet the applicable quantitative requirements following a Business Combination is intended in particular to address the difficulty companies have in identifying the number of holders they have immediately upon consummation of their Business Combination. Acquisition Company shareholders typically have the right to request redemption of their securities until immediately before consummation and it is therefore impracticable for companies to identify the number of round-lot holders immediately to demonstrate their qualification for initial listing. This proposed change is consistent with the protection of investors and the public interest, as it does not alter the substantive quantitative requirements a company must meet to remain listed.

    B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The purpose of the proposed rule is to adopt continued listing standards for Acquisition Companies that better reflect the characteristics and trading market for Acquisition Companies. While the rule may permit more Acquisition Companies to list, or remain listed, on the Exchange, other exchanges could adopt similar rules to compete for such listings. As such, the Exchange does not believe it imposes any burden on competition.

    C. Self-Regulatory Organization's Statement on Comments on the Proposed Rule Change Received From Members, Participants, or Others

    No written comments were solicited or received with respect to the proposed rule change.

    III. Date of Effectiveness of the Proposed Rule Change and Timing for Commission Action

    Within 45 days of the date of publication of this notice in the Federal Register or up to 90 days (i) as the Commission may designate if it finds such longer period to be appropriate and publishes its reasons for so finding or (ii) as to which the self-regulatory organization consents, the Commission will:

    (A) By order approve or disapprove the proposed rule change, or

    (B) institute proceedings to determine whether the proposed rule change should be disapproved.

    IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:

    Electronic Comments

    • Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or

    • Send an email to [email protected] Please include File Number SR-NYSE-2018-46 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-NYSE-2018-46. 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-NYSE-2018-46 and should be submitted on or before November 8, 2018.

    For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.11

    11 17 CFR 200.30-3(a)(12).

    Eduardo A. Aleman, Assistant Secretary.
    [FR Doc. 2018-22682 Filed 10-17-18; 8:45 am] BILLING CODE 8011-01-P
    SECURITIES AND EXCHANGE COMMISSION [Release No. 34-84418; File No. SR-FINRA-2018-026] Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a Proposed Rule Change To Amend the Arbitrator Payment Rule To Pay Each Arbitrator a $200 Honorarium To Decide Without a Hearing Session a Contested Subpoena Request or a Contested Order for Production or Appearance October 12, 2018. I. Introduction

    On July 13, 2018, Financial Industry Regulatory Authority, Inc. (“FINRA”) 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 to amend FINRA Rule 12214(c) of the Code of Arbitration Procedure for Customer Disputes (“Customer Code”) and FINRA Rule 13214(c) through (e) of the Code of Arbitration Procedure for Industry Disputes (“Industry Code” and together, “Codes”), to provide that FINRA will pay each arbitrator a $200 honorarium to decide without a hearing session a contested subpoena request or a contested order for production or appearance.

    1 15 U.S.C. 78s(b)(1).

    2 17 CFR 240.19b-4.

    The proposed rule change was published for comment in the Federal Register on July 30, 2018.3 The public comment period closed on August 20, 2018. The Commission received four comment letters in response to the Notice, all supporting the proposed rule change.4 On October 5, 2018, FINRA responded to the comment letters received in response to the Notice.5 On August 23, 2018, FINRA extended the time period in which the Commission must approve the proposed rule change, disapprove the proposed rule change, or institute proceedings to determine whether to approve or disapprove the proposed rule change to October 26, 2018.6 This order approves the proposed rule change.

    3See Exchange Act Release No. 83699 (Jul. 24, 2018), 83 FR 36647 (Jul. 30, 2018) (File No. SR-FINRA-2018-026) (“Notice”).

    4See Letter from Steven B. Caruso, Maddox Hargett Caruso, P.C., dated July 25, 2018 (“Caruso Letter”); letter from Ryan K. Bakhtiari, Aidikoff, Uhl and Bakhtiari, dated July 31, 2018 (“Bakhtiari Letter”); letter from Glenn S. Gitomer, McCausland, Keen and Buckman, dated August 1, 2018 (“Gitomer Letter”); and letter from Andrew Stoltmann, President, Public Investors Arbitration Bar Association (“PIABA”), dated August 15, 2018 (“PIABA Letter”). Comment letters are available on the Commission's website at https://www.sec.gov.

    5See Letter from Mignon McLemore, Assistant Chief Counsel, FINRA, to Mr. Brent J. Fields, Secretary, U.S. Securities and Exchange Commission, dated October 5, 2018 (“FINRA Letter”). The FINRA Letter is available on FINRA's website at http://www.finra.org, at the principal office of FINRA, at the Commission's website at http://www.finra.org/sites/default/files/rule_filing_file/SR-FINRA-2018-026-response-to-comments.pdf, and at the Commission's Public Reference Room.

    6See Letter from Mignon McLemore, Assistant Chief Counsel, FINRA, to Lourdes Gonzalez, Assistant Chief Counsel—Sales Practices, Division of Trading and Markets, Securities and Exchange Commission, dated August 23, 2018.

    II. Description of the Proposed Rule Change 7

    7 The subsequent description of the proposed rule change is substantially excerpted from FINRA's description in the Notice. See Notice, 83 FR at 36648-36649.

    Background

    Parties to an arbitration typically exchange documents and information with each other to prepare for the arbitration through the discovery process.8 If one party objects to a discovery request, the party seeking the documents or information, or appearance may file a motion requesting that the arbitrator issue a subpoena 9 or an order compelling discovery.10 The opposing party may oppose the filing party's motion, contesting the request for a subpoena 11 or order compelling discovery.

    8See FINRA Rules 12505 and 13505.

    9See FINRA Rules 12512 and 13512.

    10See FINRA Rules 12513 and 13513.

    11See FINRA Rules 12512(c) and 13512(c).

    Subpoena for Appearance

    Currently, under FINRA Rule 12214(d),12 each arbitrator who decides one or more contested subpoenas without a hearing session receives a one-time honorarium of $250 during the life of the arbitration case.13 The rule caps the total amount that the parties could pay the arbitrators to decide contested subpoena requests without a hearing in any one case at $750.14 The panel allocates the cost of the honorarium to the parties in the award.15 Arbitrators do not receive an honorarium for deciding unopposed requests to issue a subpoena.16

    12See also FINRA Rule 13214(d).

    13See FINRA Rules 12214(d)(1) and 13214(d)(1).

    If a hearing session is required to decide the motion, each arbitrator who participates in the hearing session will receive a $300 honorarium instead. See FINRA Rules 12214(a) and 13214(a).

    14See FINRA Rules 12214(d)(1) and 13214(d)(1). The chairperson of a three-person panel will decide the contested subpoena request without a hearing session, for which the chairperson would be paid $250. The honorarium for contested subpoena requests could increase in $250 increments, if, for example, the chairperson recuses or withdraws from the panel and the replacement chairperson must decide another contested subpoena request without a hearing session. In this instance, the replacement chairperson would receive a $250 honorarium for this work. In no event would the parties be charged more than $750 per case. See Notice at 36648, note 14.

    15See FINRA Rules 12214(d)(3) and 13214(d)(3).

    16See Notice at 36648.

    Order for Production or Appearance

    The Codes do not expressly provide an honorarium for arbitrators who decide requests for orders for production or appearance without a hearing session. FINRA does, however, provide arbitrators a $200 honorarium to decide discovery-related motions without a hearing. 17 Accordingly, FINRA categorizes requests to issue orders for production as discovery-related motions and pays $200 honorarium for each arbitrator deciding the order, regardless of whether it is contested. FINRA does not pay the honorarium, however, for an order for appearance, regardless of whether it is contested or unopposed.18

    17 FINRA Rules 12214(c) and 13214(c) provide that FINRA will pay each arbitrator an honorarium of $200 to decide a discovery-related motion without a hearing session.

    18See Notice at 36648-36649.

    Proposed Rule Change

    FINRA is proposing to amend FINRA Rules 12214(c) and 13214(c) to provide that FINRA would pay each arbitrator an honorarium of $200 to decide, without a hearing session: (i) A discovery-related motion; 19 (ii) a motion that contains one or more contested subpoena requests 20 or contested orders for production or appearance; or (iii) a motion that contains one or more contested subpoena requests and contested orders for production or appearance.21

    19 Under the proposed rule change, FINRA would add a contested subpoena request and a contested order for production or appearance to the discovery-related motions rule; however, FINRA would not change the rule language explaining what constitutes a discovery-related motion. See Notice at 36649, note 27.

    20 The proposal would retain what constitutes a contested subpoena by moving the description from FINRA Rule 12214(d)(2) to FINRA Rule 12214(c)(2)(ii). See Notice at 36649, note 28.

    21See Notice at 36649.

    Contested Subpoena

    Specifically, the proposed rule change would reduce the honorarium that an arbitrator receives to decide a contested subpoena request from $250 to $200; however, it would also remove the per-case cap on these payments. Thus, under the proposed rule change, an arbitrator would receive a $200 honorarium for each contested subpoena request that he or she decides.22

    22See id. As is current practice, arbitrators would not receive an honorarium for an unopposed subpoena request. See Notice at 36649, note 29.

    Contested Orders for Production or Appearance

    In addition, the proposed rule change would now expressly provide a $200 honorarium for arbitrators deciding a contested order for production or appearance without a hearing session. Specifically, FINRA would not need to categorize requests to issue orders for production as discovery-related motions. Similarly, arbitrators would receive an honorarium for deciding without a hearing session, a contested arbitrator order for appearance as well as for production. Under the proposal, however, arbitrators would no longer receive an honorarium for deciding unopposed requests to issue an order for production.23

    23See Notice at 36649.

    The proposed rule change would describe what constitutes a contested order for production or appearance by modeling the description on that of a contested subpoena request. Specifically, proposed FINRA Rule 12214(c)(2)(iii) would provide that a contested order for production or appearance shall include a motion requesting the issuance of an order for production or appearance, a written objection from the party opposing the issuance of the order, and any other documents supporting a party's position.24

    24Id.

    Moreover, like a contested subpoena request, a party would be permitted to request the issuance of one or more orders in one motion,25 and if one or all of the arbitrator orders become contested, each arbitrator who decides the motion would receive one honorarium payment of $200.26

    25 The proposed rule change would also permit parties to request the issuance of one or more subpoenas in the same motion or a combination of subpoena and order requests. See Notice at 36649, note 30.

    26See Notice at 36649.

    Additional Proposed Changes

    The proposed rule change would also amend Rules 12214(a) and 13214(a) to make a few non-substantive changes.27

    27See id.

    III. Comment Summary Supportive Comments

    As noted above, the Commission received four comment letters on the proposed rule change, supporting the proposal.28 All four commenters support the proposal and believe that it represents a fair and reasonable approach to helping ensure that arbitrators are compensated according to the time and effort they devote to deciding a motion.29 Specifically, one commenter states that “removing the per-case cap on [honorarium for contested subpoena requests] would provide consistency and fairness to the arbitrator payment rules by ensuring that the payment arbitrators receive for deciding these requests is commensurate with the time and effort spent on each motion.” 30 Two other commenters believe that the proposal would help FINRA retain and recruit qualified arbitrators to its arbitration forum.31 In particular, one commenter states that “paying arbitrators fair honoraria commensurate with the time and effort required for deciding motions tends to encourage qualified arbitrators to serve on cases and as Chair.” 32

    28See supra note 4.

    29See Caruso Letter, Bakhtiari Letter, Gitomer Letter, and PIABA Letter; see also FINRA Letter.

    30 Caruso Letter; see also Gitomer Letter (stating that the proposal would provide “reasonable compensation for the time and effort spent in deciding these important requests.”).

    31See Bakhtiari Letter and PIABA Letter.

    32 PIABA Letter; see also Bakhtiari Letter (stating that “fairly compensate[ing] arbitration Chairpersons for deciding contested subpoenas and orders of production and appearance” would help FINRA recruit and retain qualified arbitrators to preside over its forum.).

    Additional Guidance

    One commenter also suggests that FINRA take additional action regarding the assessment of fees related to discovery-related motions for subpoenas and orders. Specifically, the commenter suggests that FINRA should “informally advise arbitrators to consider assessing all fees to the non-prevailing party on contested discovery motions, where in the arbitrators' view the non-prevailing party's position lacked merit.” 33 Otherwise, the commenter suggests arbitrators may “naturally” split fees between the parties which could encourage “spurious” motion practice.34

    33 PIABA Letter.

    34See id.

    In response, FINRA states that its arbitration forum already provides a mechanism for parties to argue their positions regarding the assessments of fees associated with an arbitration proceeding.35 Specifically, FINRA states that in the absence of an agreement between the parties governing the allocation of these fees, FINRA Rules 12902(c) and 13902(c) give arbitrators discretion to determine how these fees should be allocated in an award.36 FINRA also states, however, that “[p]arties may argue their positions regarding the appropriate assessment of fees and expenses in their motion papers or responses thereto the panel.” 37 Accordingly, FINRA rejects the notion that formal guidance on a panel's authority is necessary.38

    35See supra note 5.

    36See FINRA Letter.

    37 FINRA Letter.

    38See FINRA Letter.

    IV. Discussion and Commission Findings

    After careful review of the proposed rule change and the comment letters, the Commission finds that the proposal is consistent with the requirements of the Exchange Act and the rules and regulations thereunder that are applicable to a national securities association.39 Specifically, the Commission finds that the proposed rule change is consistent with Section 15A(b)(6) of the Exchange Act,40 which requires, among other things, that FINRA rules be designed to prevent fraudulent and manipulative acts and practices, to promote just and equitable principles of trade, and, in general, to protect investors and the public interest, and Exchange Act Section 15A(b)(5) of the Exchange Act,41 which requires, among other things, that FINRA rules provide for the equitable allocation of reasonable dues, fees and other charges among members and issuers and other persons using any facility or system that FINRA operates or controls.

    39 In approving this rule change, the Commission has considered the rule's impact on efficiency, competition, and capital formation. See 15 U.S.C. 78c(f).

    40 15 U.S.C. 78o-3(b)(6).

    41 15 U.S.C. 78o-3(b)(5).

    The Commission agrees with FINRA and the commenters that the proposed rule change would protect investors and the public interest by improving the FINRA arbitration forum for the parties that use it and the arbitrators who preside over claims.42 Currently, the FINRA rules governing fees and corresponding honoraria for the resolution of discovery-related subpoenas and orders in arbitration vary. As stated above, an arbitrator who decides one or more contested subpoenas without a hearing receives $250. An arbitrator receives no honorarium, however, for: (i) Deciding an unopposed request to issue a subpoena; or (ii) deciding requests for orders for appearance without a hearing. Furthermore, FINRA states that arbitrators only receive honorarium for deciding requests for orders for production without a hearing (for which an arbitrator would receive no honorarium) because FINRA typically characterizes them as discovery-related motions without a hearing so that it can pay $200 honorarium to each arbitrator for deciding the motion.43

    42See supra note 28; see also FINRA Letter.

    43See supra notes 17 and 18.

    The proposal would make the rules more transparent and consistent for both parties and arbitrators by providing for payments to each arbitrator of an honorarium of $200 to decide, without a hearing session: (i) A discovery-related motion; (ii) a motion that contains one or more contested subpoena requests or contested orders for production or appearance; or (iii) a motion that contains one or more contested subpoena requests and contested orders for production or appearance.44 According to FINRA, the existing structure for payments to arbitrators for deciding requests to issue subpoenas or orders without a hearing session has been difficult for parties and arbitrators to understand due to the differences between when, and under what circumstances, arbitrators will receive payments.45 For example, parties can incur different fees, and arbitrators can receive different honoraria, for contested and unopposed requests to issue subpoenas and orders.46

    44See Notice at 36649.

    45See Notice at 36650; see also Notice at 36650, note 34.

    46See Notice at 36650.

    The Commission believes the proposal would also help FINRA retain and recruit qualified arbitrators to its forum by helping ensure arbitrators are paid honoraria commensurate with the time and effort they devote to deciding each request. As stated in the Notice, arbitrators must review several documents related to contested discovery-related requests: The motions requesting the issuance of the order or subpoena; the draft order or subpoena; and, any written objections to the motion. Arbitrators must then consider the arguments before making decisions on the merits of the request.47 Despite the similar type and amount of work necessary to decide certain discovery-related requests for orders and subpoenas without a hearing, the rules expressly provide honoraria to arbitrators for deciding a contested subpoena but not for deciding a contested order.

    47See Notice at 36648.

    The Commission believes that by structuring the arbitrator honorarium rules so that arbitrators receive the same amount of honorarium for each contested subpoena request or contested request for an order for production or appearance they decide without a hearing, the proposed rules would align the payment of honoraria to arbitrators based on the amount of time and effort required to revolve certain discovery-related motions rather than based on the characterization of those requests.48 The Commission also believes that simplifying the rules governing the payment of honorarium would help improve arbitrators' understanding of the honorarium structure.

    48See Notice at 36649.

    The Commission acknowledges that the proposed rule change could increase fees for certain parties. For example, under the proposed rule change parties would be subject to fees for contested requests to issue orders of appearance without a hearing session; and, the proposal would remove the per-case cap on fees for contested subpoena requests so that parties would be assessed additional fees if they submit multiple contested requests for subpoenas.

    The Commission also acknowledges that the proposed rule change could lower fees for certain parties. For example, the proposal would: (i) Eliminate payment of honoraria to arbitrators deciding an unopposed order for production; and (ii) lower the amount of honoraria paid to arbitrators for deciding a contested subpoena request from $250 to $200. In addition, the proposal would permit a party or parties to use one motion to request the issuance of one or more contested subpoenas or orders so that parties could mitigate their fees.49 The Commission also acknowledges, however, that the proposal would eliminate the per-case cap honoraria so arbitrators could receive additional payments for multiple contested requests for subpoenas.50

    49See Notice at 36649 and 36651.

    50See id.

    On balance, the Commission believes that the proposed rule change is designed to protect investors and the public interest. Notwithstanding the potential increase in fees to some parties in arbitration, the Commission believes that the proposal would improve the FINRA arbitration forum for its users.51

    51 The Commission also notes that the proposal would help parties mitigate any potential fee increase by allowing parties to request one or more contested subpoenas or orders in one motion.

    In addition, notwithstanding the potential decrease in honoraria in some cases, the Commission believes that the proposal would help FINRA retain and recruit qualified arbitrators to its forum.52 In particular the Commission believes that reducing the honoraria for contested subpoena requests while removing the per-case cap on these payments would help ensure that the honoraria arbitrators receive for deciding contested requests for orders and subpoenas without a hearing would be more commensurate with their time and effort to consider the requests.53 Furthermore, the Commission believes that retaining and recruiting qualified arbitrators is an essential element to operating an effective arbitration forum.54

    52 The Commission also notes that the proposal would mitigate these decreases by removing the per-case cap on these honorarium payments.

    53See supra note 29.

    54See Notice at 36650; see also supra note 32.

    The Commission acknowledges one commenter's request that FINRA provide additional guidance to arbitrators regarding their authority to assess all fees to the non-prevailing party on contested discovery motions, where in the arbitrators' view the non-prevailing party's position lacked merit.55 However, the Commission notes FINRA's statement that a mechanism for checking arbitrators' assessments of fees associated with an arbitration proceeding already exists.56 Accordingly, the Commission acknowledges FINRA's decisions not to provide additional formal guidance to its arbitrators.57

    55See supra notes 33 and 34.

    56See supra note 37.

    57See supra note 38.

    V. Conclusion

    It is therefore ordered pursuant to Section 19(b)(2) of the Exchange Act 58 that the proposal (SR-FINRA-2018-026), be and hereby is approved.

    58 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.59

    59 17 CFR 200.30-3(a)(12).

    Eduardo A. Aleman, Assistant Secretary.
    [FR Doc. 2018-22681 Filed 10-17-18; 8:45 am] BILLING CODE 8011-01-P
    SECURITIES AND EXCHANGE COMMISSION [Investment Company Act Release No. 33270; File No. 812-14862] Audax Credit BDC Inc., et al.; Notice of Application October 12, 2018. AGENCY:

    Securities and Exchange Commission (“Commission”).

    ACTION:

    Notice.

    Notice of an application for an order under sections 17(d) and 57(i) of the Investment Company Act of 1940 (the “Act”) and rule 17d-1 under the Act permitting certain joint transactions otherwise prohibited by sections 17(d) and 57(a)(4) of the Act and rule 17d-1 under the Act.

    Summary of Application:

    Applicants request an order to permit a business development company (“BDC”) and certain closed-end investment companies to co-invest in portfolio companies with each other and with affiliated investment funds.

    Applicants:

    Audax Credit BDC Inc. (the “Company”), Audax Credit Strategies (SCS), L.P. (“SCS”), Audax Credit Opportunities (SBA), LLC (“SBA”), Audax Senior Debt (MP), LLC (“MP”), Audax Senior Debt (WCTPT), LLC (“WCTPT”), Audax Senior Debt (AZ), LLC (“AZ”), Audax Senior Loan Fund I, L.P. (“SLF I”), Audax Senior Loan Fund I (Offshore), L.P. (“SLF I(O)”), Audax Senior Loan Fund, L.P. (“SLF”), Audax Senior Loan Fund III, L.P. (“SLF III”), Audax Senior Loan Fund III (Offshore), L.P. (“SLF III(O)”), Audax Senior Loan Fund (ST), LP (“SLF(ST)”), Audax Direct Lending Solutions Fund-A, L.P. (“Direct Lending-A”), Audax Direct Lending Solutions Fund-B, L.P. (“Direct Lending-B”), Audax Direct Lending Solutions Fund-C, L.P. (“Direct Lending-C”), Audax Direct Lending Solutions Fund-D, L.P. (“Direct Lending-D” and, collectively with SCS, SBA, MP, WCTPT, AZ, SLF I, SLF I(O), SLF, SLF III, SLF III(O), SLF(ST), Direct Lending-A, Direct Lending-B, and Direct Lending-C, the “Private Funds”), and Audax Management Company (NY), LLC (the “Company Adviser,” and collectively with the Company and the Private Funds, the “Applicants”).

    Filing Dates:

    The application was filed on December 29, 2017 and amended on June 14, 2018.

    Hearing or Notification of Hearing:

    An order granting the requested relief will be issued unless the Commission orders a hearing. Interested persons may request a hearing by writing to the Commission's Secretary and serving applicants with a copy of the request, personally or by mail. Hearing requests should be received by the Commission by 5:30 p.m. on November 6, 2018 and should be accompanied by proof of service on applicants, in the form of an affidavit or, for lawyers, a certificate of service. Pursuant to rule 0-5 under the Act, hearing requests should state the nature of the writer's interest, any facts bearing upon the desirability of a hearing on the matter, the reason for the request, and the issues contested. Persons who wish to be notified of a hearing may request notification by writing to the Commission's Secretary.

    ADDRESSES:

    Secretary, U.S. Securities and Exchange Commission, 100 F St. NE, Washington, DC 20549-1090. Applicants: 101 Huntington Avenue, Boston, Massachusetts 02199.

    FOR FURTHER INFORMATION CONTACT:

    Jill Ehrlich, Senior Counsel, at (202) 551-6819, or Andrea Ottomanelli Magovern, Branch Chief, at (202) 551-6821 (Chief Counsel's Office, Division of Investment Management).

    SUPPLEMENTARY INFORMATION:

    The following is a summary of the application. The complete application may be obtained via the Commission's website by searching for the file number, or for an applicant using the Company name box, at http://www.sec.gov/search/search.htm or by calling (202) 551-8090.

    Applicants' Representations

    1. The Company was organized as a corporation under the General Corporation Law of the State of Delaware on January 29, 2015 and elected to be treated as a BDC 1 through a notification of election to be subject to sections 55 through 65 of the Act on Form N-54A. The Company's “Objectives and Strategies” 2 are to generate current income and, to a lesser extent, long-term capital appreciation by investing primarily in senior secured debt of privately owned U.S. middle-market companies. The Company has a five-member board of directors (the “Board”), of which three members are not “interested persons” of the Company within the meaning of section 2(a)(19) of the Act (the “Non-Interested Directors”). No Non-Interested Director will have any direct or indirect financial interest in any Co-Investment Transaction (defined below) or any interest in any portfolio company, other than indirectly through share ownership (if any) in the Company or a Future Regulated Fund (defined below).

    1 Section 2(a)(48) of the Act defines a BDC to be any closed-end investment company that operates for the purpose of making investments in securities described in section 55(a)(1) through 55(a)(3) of the Act and makes available significant managerial assistance with respect to the issuers of such securities.

    2 “Objectives and Strategies” means, with respect to a Regulated Fund (defined below), the investment objectives and strategies of such Regulated Fund, as described in such Regulated Fund's registration statement, other filings the Regulated Fund has made with the Commission under the Act, Securities Act of 1933 (the “1933 Act”), or under the Securities Exchange Act of 1934, or in the Regulated Fund's reports to stockholders.

    2. SCS was formed as a Delaware limited partnership on March 10, 2014 and would be an investment company but for the exclusion from the definition of investment company provided by section 3(c)(7) of the Act. SCS's investment objective is to invest primarily in a portfolio of secured and unsecured loans and other debt instruments, seeking low volatility, principal protection and current income. SCS has an investment strategy that is similar to the Company's investment strategy.

    3. SBA was formed as a Delaware limited liability company on March 10, 2010 and would be an investment company but for the exclusion from the definition of investment company provided by section 3(c)(7) of the Act. SBA's investment objective is to invest primarily in a portfolio of secured and unsecured loans and other debt instruments, seeking low volatility, principal protection and current income. SBA has an investment strategy that is similar to the Company's investment strategy.

    4. MP was formed as a Delaware limited liability company on June 28, 2017 and would be an investment company but for the exclusion from the definition of investment company provided by section 3(c)(7) of the Act. MP's investment objective is to invest primarily in a portfolio of secured and unsecured loans and other debt instruments, seeking low volatility, principal protection and current income. MP has an investment strategy that is similar to the Company's investment strategy.

    5. WCTPT was formed as a Delaware limited liability company on October 25, 2011 and would be an investment company but for the exclusion from the definition of investment company provided by section 3(c)(7) of the Act. WCTPT's investment objective is to invest in a portfolio of first lien senior secured loans, seeking low volatility, principal protection and current income for WCTPT. WCTPT has an investment strategy that is similar to the Company's investment strategy.

    6. AZ was formed as a Delaware limited liability company on November 20, 2017 and would be an investment company but for the exclusion from the definition of investment company provided by section 3(c)(7) of the Act. AZ's investment objective is to invest primarily in a portfolio of secured and unsecured loans and other debt instruments, seeking low volatility, principal protection and current income. AZ has an investment strategy that is similar to the Company's investment strategy.

    7. SLF I was formed as a Delaware limited partnership on July 23, 2007 and would be an investment company but for the exclusion from the definition of investment company provided by section 3(c)(7) of the Act. SLF I's investment objective is to invest primarily in a portfolio of secured and unsecured loans and other debt instruments, seeking low volatility, principal protection and current income. SLF I has an investment strategy that is similar to the Company's investment strategy.

    8. SLF I(O) was formed as a Cayman Islands exempted limited partnership on October 2, 2007 and would be an investment company but for the exclusion from the definition of investment company provided by section 3(c)(7) of the Act. SLF I(O)'s investment objective is to invest primarily in a portfolio of secured and unsecured loans and other debt instruments, seeking low volatility, principal protection and current income. SLF(IO) has an investment strategy that is similar to the Company's investment strategy.

    9. SLF was formed as a Delaware limited partnership on August 10, 2012 and would be an investment company but for the exclusion from the definition of investment company provided by section 3(c)(7) of the Act. The investment objective of SLF is to invest primarily in a portfolio of first lien senior secured loans to North American middle market companies, although a portion of the its portfolio may be invested in mezzanine, second lien, distressed and other securities or instruments, including securities or instruments of non-North American companies. SLF has an investment strategy that is similar to the Company's investment strategy.

    10. SLF III was formed as a Delaware limited partnership on January 19, 2016 and would be an investment company but for the exclusion from the definition of investment company provided by section 3(c)(7) of the Act. The investment objective of SLF III is to invest primarily in a portfolio of first lien senior secured loans to North American middle market companies, although a portion of the its portfolio may be invested in mezzanine, second lien, distressed and other securities or instruments, including securities or instruments of non-North American companies. SLF III has an investment strategy that is similar to the Company's investment strategy.

    11. SLF III(O) was formed as a Cayman Islands exempted limited partnership on May 25, 2016 and would be an investment company but for the exclusion from the definition of investment company provided by section 3(c)(7) of the Act. The investment objective of SLF III(O) is to invest primarily in a portfolio of first lien senior secured loans to North American middle market companies, although a portion of the its portfolio may be invested in mezzanine, second lien, distressed and other securities or instruments, including securities or instruments of non-North American companies. SLF III(O) has an investment strategy that is similar to the Company's investment strategy.

    12. SLF (ST) was formed as a Delaware limited partnership on May 16, 2018 and would be an investment company but for the exclusion from the definition of investment company provided by section 3(c)(7) of the Act. The investment objective of SLF (ST) is to invest primarily in a portfolio of secured and unsecured loans and other debt instruments, seeking low volatility, principal protection and current income. SLF (ST) has an investment strategy that is similar to the Company's investment strategy.

    13. Direct Lending-A, Direct Lending-B and Direct Lending-C were each formed as a Delaware limited partnership on October 12, 2017, October 12, 2017 and April 5, 2017, respectively, and each would be an investment company but for the exclusion from the definition of investment company provided by section 3(c)(7) of the Act. Direct Lending-D was formed as a Cayman Islands exempted limited partnership on April 10, 2018 and would be an investment company but for the exclusion from the definition of investment company provided by section 3(c)(7) of the Act. The investment objective of each of Direct Lending-A, Direct Lending-B, Direct Lending-C, and Direct Lending-D is to engage in direct lending to private middle market companies based in the United States and Canada through a variety of structures, and primarily via unitranche and stretch senior secured loans, with selected positions in senior secured first or second lien loans, equity and similar investments. The investment strategy of each of Direct Lending-A, Direct Lending-B, Direct Lending-C, and Direct Lending-D overlaps with the Company's investment strategy.

    14. The Company Adviser, a Delaware limited liability company and an investment adviser registered with the Commission under the Investment Advisers Act of 1940 (“Advisers Act”), serves as investment adviser to both the Company and each of the Private Funds. Under the investment advisory agreements of the Company and the Private Funds, the Company Adviser manages the portfolio of each entity in accordance with the investment objective and policies of each, makes investment decisions for each entity, places purchase and sale orders for portfolio transactions for each entity, and otherwise manages the day-to-day operations of each entity, subject, in the case of the Company, to the oversight of its Board.

    15. Applicants seek an order (“Order”) to permit one or more Regulated Funds 3 and/or one or more Affiliated Funds 4 to participate in the same investment opportunities through a proposed co-investment program (the “Co-Investment Program”) where such participation would otherwise be prohibited under section 57(a)(4) and rule 17d-1 by (a) co-investing with each other in securities issued by issuers in private placement transactions in which an Adviser negotiates terms in addition to price; 5 and (b) making additional investments in securities of such issuers, including through the exercise of warrants, conversion privileges, and other rights to purchase securities of the issuers (“Follow-On Investments”). “Co-Investment Transaction” means any transaction in which a Regulated Fund (or its Wholly-Owned Investment Subsidiary) participates together with one or more other Regulated Funds and/or one or more Affiliated Funds in reliance on the requested Order.6 “Potential Co-Investment Transaction” means any investment opportunity in which a Regulated Fund (or its Wholly-Owned Investment Subsidiary) could not participate together with one or more Affiliated Funds and/or one or more other Regulated Funds without obtaining and relying on the Order.7

    3 “Regulated Fund” means the Company and any Future Regulated Fund. “Future Regulated Fund” means any closed-end management investment company (a) that is registered under the Act or has elected to be regulated as a BDC, (b) whose investment adviser is an Adviser, and (c) that intends to participate in the Co-Investment Program. The term “Adviser” means (a) the Company Adviser and (b) any future investment adviser that controls, is controlled by or is under common control with the Company Adviser or its successor and is registered as an investment adviser under the Advisers Act. The term “successor,” as applied to each Adviser, means an entity that results from a reorganization into another jurisdiction or change in the type of business organization.

    4 “Affiliated Fund” means the Private Funds and any Future Affiliated Fund. “Future Affiliated Fund” means any entity (a) whose investment adviser is an Adviser, (b) that would be an investment company but for section 3(c)(1) or 3(c)(7) of the Act, and (c) that intends to participate in the Co-Investment Program.

    5 The term “private placement transactions” means transactions in which the offer and sale of securities by the issuer are exempt from registration under the 1933 Act.

    6 The term “Wholly-Owned Investment Subsidiary” means an entity (i) that is wholly-owned by a Regulated Fund (with the Regulated Fund at all times holding, beneficially and of record, 100% of the voting and economic interests); (ii) whose sole business purpose is to hold one or more investments and incur debt (which is or would be consolidated with other indebtedness of such Regulated Fund for financial reporting or compliance purposes under the Act) on behalf of the Regulated Fund; (iii) with respect to which the Regulated Fund's Board has the sole authority to make all determinations with respect to the entity's participation under the conditions of the application; and (iv) that would be an investment company but for sections 3(c)(1) or 3(c)(7) of the Act.

    7 All existing entities that currently intend to rely upon the requested Order have been named as applicants. Any other existing or future entity that subsequently relies on the Order will comply with the terms and conditions of the application.

    16. Applicants state that a Regulated Fund may, from time to time, form one or more Wholly-Owned Investment Subsidiaries. Such a subsidiary would be prohibited from investing in a Co-Investment Transaction with any Affiliated Fund or Regulated Fund because it would be a company controlled by its parent Regulated Fund for purposes of section 57(a)(4) and rule 17d-1. Applicants request that each Wholly-Owned Investment Subsidiary be permitted to participate in Co-Investment Transactions in lieu of its parent Regulated Fund and that the Wholly-Owned Investment Subsidiary's participation in any such transaction be treated, for purposes of the requested Order, as though the parent Regulated Fund were participating directly. Applicants represent that this treatment is justified because a Wholly-Owned Investment Subsidiary would have no purpose other than serving as a holding vehicle for the parent Regulated Fund's investments and, therefore, no conflicts of interest could arise between a Regulated Fund and its Wholly-Owned Investment Subsidiary. The applicable Regulated Fund's Board would make all relevant determinations under the conditions with regard to a Wholly-Owned Investment Subsidiary's participation in a Co-Investment Transaction, and the Regulated Fund's Board would be informed of, and take into consideration, any proposed use of a Wholly-Owned Investment Subsidiary in the Regulated Fund's place. If the Regulated Fund proposes to participate in the same Co-Investment Transaction with any of its Wholly-Owned Investment Subsidiaries, the Board will also be informed of, and take into consideration, the relative participation of the Regulated Fund and the Wholly-Owned Investment Subsidiary.

    17. When considering Potential Co-Investment Transactions for any Regulated Fund, the applicable Adviser will consider only the Objectives and Strategies, investment policies, investment positions, capital available for investment (“Available Capital”), and other pertinent factors applicable to that Regulated Fund. The Board of each Regulated Fund, including the Non-Interested Directors, has (or will have prior to relying on the requested Order) determined that it is in the best interests of the Regulated Fund to participate in the Co-Investment Transaction.

    18. Other than pro rata dispositions and Follow-On Investments as provided in conditions 7 and 8, and after making the determinations required in conditions 1 and 2(a), the Adviser will present each Potential Co-Investment Transaction and the proposed allocation to the directors of the Board eligible to vote under section 57(o) of the Act (“Eligible Directors”), and the “required majority,” as defined in section 57(o) of the Act (“Required Majority”) 8 will approve each Co-Investment Transaction prior to any investment by the participating Regulated Fund.

    8 In the case of a Regulated Fund that is a registered closed-end fund, the Board members that make up the Required Majority will be determined as if the Regulated Fund were a BDC subject to section 57(o).

    19. With respect to the pro rata dispositions and Follow-On Investments provided in conditions 7 and 8, a Regulated Fund may participate in a pro rata disposition or Follow-On Investment without obtaining prior approval of the Required Majority if, among other things: (i) The proposed participation of each Regulated Fund and Affiliated Fund in such disposition is proportionate to its outstanding investments in the issuer immediately preceding the disposition or Follow-On Investment, as the case may be; and (ii) the Board of the Regulated Fund has approved that Regulated Fund's participation in pro rata dispositions and Follow-On Investments as being in the best interests of the Regulated Fund. If the Board does not so approve, any such disposition or Follow-On Investment will be submitted to the Regulated Fund's Eligible Directors. The Board of any Regulated Fund may at any time rescind, suspend or qualify its approval of pro rata dispositions and Follow-On Investments with the result that all dispositions and/or Follow-On Investments must be submitted to the Eligible Directors.

    20. Applicants also represent that if the Advisers, the principals of the Advisers (“Principals”), or any person controlling, controlled by, or under common control with an Adviser or the Principals, and the Affiliated Funds (collectively, the “Holders”) own in the aggregate more than 25% of the outstanding voting shares of a Regulated Fund (the “Shares”), then the Holders will vote such Shares as required under condition 14. Applicants believe this condition will ensure that the Non-Interested Directors will act independently in evaluating the Co-Investment Program, because the ability of the Advisers or the Principals to influence the Non-Interested Directors by a suggestion, explicit or implied, that the Non-Interested Directors can be removed will be limited significantly. Applicants represent that the Non-Interested Directors will evaluate and approve any such independent third party, taking into account its qualifications, reputation for independence, cost to the stockholders, and other factors that they deem relevant.

    Applicants' Legal Analysis

    1. Section 57(a)(4) of the Act prohibits certain affiliated persons of a BDC from participating in joint transactions with the BDC or a company controlled by a BDC in contravention of rules as prescribed by the Commission. Under section 57(b)(2) of the Act, any person who is directly or indirectly controlling, controlled by, or under common control with a BDC is subject to section 57(a)(4). Applicants submit that each of the Regulated Funds and Affiliated Funds could be deemed to be a person related to each Regulated Fund in a manner described by section 57(b) by virtue of being under common control. Section 57(i) of the Act provides that, until the Commission prescribes rules under section 57(a)(4), the Commission's rules under section 17(d) of the Act applicable to registered closed-end investment companies will be deemed to apply to transactions subject to section 57(a)(4). Because the Commission has not adopted any rules under section 57(a)(4), rule 17d-1 also applies to joint transactions with Regulated Funds that are BDCs. Section 17(d) of the Act and rule 17d-1 under the Act are applicable to Regulated Funds that are registered closed-end investment companies.

    2. Section 17(d) of the Act and rule 17d-1 under the Act prohibit affiliated persons of a registered investment company from participating in joint transactions with the company unless the Commission has granted an order permitting such transactions. In passing upon applications under rule 17d-1, the Commission considers whether the company's participation in the joint transaction is consistent with the provisions, policies, and purposes of the Act and the extent to which such participation is on a basis different from or less advantageous than that of other participants.

    3. Applicants state that in the absence of the requested relief, the Regulated Funds would be, in some circumstances, limited in their ability to participate in attractive and appropriate investment opportunities. Applicants believe that the proposed terms and conditions will ensure that the Co-Investment Transactions are consistent with the protection of each Regulated Fund's shareholders and with the purposes intended by the policies and provisions of the Act. Applicants state that the Regulated Funds' participation in the Co-Investment Transactions will be consistent with the provisions, policies, and purposes of the Act and on a basis that is not different from or less advantageous than that of other participants.

    Applicants' Conditions

    Applicants agree that the Order will be subject to the following conditions:

    1. Each time an Adviser considers a Potential Co-Investment Transaction for an Affiliated Fund or another Regulated Fund that falls within a Regulated Fund's then-current Objectives and Strategies, the Regulated Fund's Adviser will make an independent determination of the appropriateness of the investment for the Regulated Fund in light of the Regulated Fund's then-current circumstances.

    2.

    (a) If the Adviser deems a Regulated Fund's participation in any Potential Co-Investment Transaction to be appropriate for the Regulated Fund, it will then determine an appropriate level of investment for the Regulated Fund.

    (b) If the aggregate amount recommended by the applicable Adviser to be invested by the applicable Regulated Fund in the Potential Co-Investment Transaction, together with the amount proposed to be invested by the other participating Regulated Funds and Affiliated Funds, collectively, in the same transaction, exceeds the amount of the investment opportunity, the investment opportunity will be allocated among them pro rata based on each participant's Available Capital, up to the amount proposed to be invested by each. The applicable Adviser will provide the Eligible Directors of each participating Regulated Fund with information concerning each participating party's Available Capital to assist the Eligible Directors with their review of the Regulated Fund's investments for compliance with these allocation procedures.

    (c) After making the determinations required in conditions 1 and 2(a), the applicable Adviser will distribute written information concerning the Potential Co-Investment Transaction (including the amount proposed to be invested by each participating Regulated Fund and Affiliated Fund) to the Eligible Directors of each participating Regulated Fund for their consideration. A Regulated Fund will co-invest with one or more other Regulated Funds and/or one or more Affiliated Funds only if, prior to the Regulated Fund's participation in the Potential Co-Investment Transaction, a Required Majority concludes that:

    (i) The terms of the Potential Co-Investment Transaction, including the consideration to be paid, are reasonable and fair to the Regulated Fund and its stockholders and do not involve overreaching in respect of the Regulated Fund or its stockholders on the part of any person concerned;

    (ii) the Potential Co-Investment Transaction is consistent with:

    (A) The interests of the Regulated Fund's stockholders; and

    (B) the Regulated Fund's then-current Objectives and Strategies;

    (iii) the investment by any other Regulated Funds or Affiliated Funds would not disadvantage the Regulated Fund, and participation by the Regulated Fund would not be on a basis different from or less advantageous than that of any other Regulated Funds or Affiliated Funds; provided that if any other Regulated Funds or Affiliated Funds, but not the Regulated Fund itself, gains the right to nominate a director for election to a portfolio company's board of directors or the right to have a board observer or any similar right to participate in the governance or management of the portfolio company, such event shall not be interpreted to prohibit the Required Majority from reaching the conclusions required by this condition (2)(c)(iii), if:

    (A) The Eligible Directors will have the right to ratify the selection of such director or board observer, if any;

    (B) the applicable Adviser agrees to, and does, provide periodic reports to the Regulated Fund's Board with respect to the actions of such director or the information received by such board observer or obtained through the exercise of any similar right to participate in the governance or management of the portfolio company; and

    (C) any fees or other compensation that any Affiliated Fund or any Regulated Fund or any affiliated person of any Affiliated Fund or any Regulated Fund receives in connection with the right of the Affiliated Fund or Regulated Fund to nominate a director or appoint a board observer or otherwise to participate in the governance or management of the portfolio company will be shared proportionately among the participating Affiliated Funds (who each may, in turn, share its portion with its affiliated persons) and the participating Regulated Fund in accordance with the amount of each party's investment; and

    (iv) the proposed investment by the Regulated Fund will not benefit the Advisers, any Affiliated Funds or other Regulated Funds or any affiliated person of any of them (other than the parties to the Co-Investment Transaction), except (A) to the extent permitted by condition 13, (B) to the extent permitted by section 17(e) or 57(k) of the Act, as applicable, (C) indirectly, as a result of an interest in the securities issued by one of the parties to the Co-Investment Transaction, or (D) in the case of fees or other compensation described in condition 2(c)(iii)(C).

    3. Each Regulated Fund has the right to decline to participate in any Potential Co-Investment Transaction or to invest less than the amount proposed.

    4. The applicable Adviser will present to the Board of each Regulated Fund, on a quarterly basis, a record of all investments in Potential Co-Investment Transactions made by any of the other Regulated Funds or Affiliated Funds during the preceding quarter that fell within the Regulated Fund's then-current Objectives and Strategies that were not made available to the Regulated Fund, and an explanation of why the investment opportunities were not offered to the Regulated Fund. All information presented to the Board pursuant to this condition will be kept for the life of the Regulated Fund and at least two years thereafter, and will be subject to examination by the Commission and its staff.

    5. Except for Follow-On Investments made in accordance with condition 8,9 a Regulated Fund will not invest in reliance on the Order in any issuer in which another Regulated Fund, an Affiliated Fund or any affiliated person of another Regulated Fund or Affiliated Fund is an existing investor.

    9 This exception applies only to Follow-On Investments by a Regulated Fund in issuers in which the Regulated Fund already holds investments.

    6. A Regulated Fund will not participate in any Potential Co-Investment Transaction unless the terms, conditions, price, class of securities to be purchased, settlement date, and registration rights will be the same for each participating Regulated Fund and Affiliated Fund. The grant to an Affiliated Fund or another Regulated Fund, but not the Regulated Fund, of the right to nominate a director for election to a portfolio company's board of directors, the right to have an observer on the board of directors or similar rights to participate in the governance or management of the portfolio company will not be interpreted so as to violate this condition 6, if conditions 2(c)(iii)(A), (B) and (C) are met.

    7.

    (a) If any Affiliated Fund or any Regulated Fund elects to sell, exchange or otherwise dispose of an interest in a security that was acquired in a Co-Investment Transaction, the applicable Advisers will:

    (i) Notify each Regulated Fund that participated in the Co-Investment Transaction of the proposed disposition at the earliest practical time; and

    (ii) formulate a recommendation as to participation by each Regulated Fund in the disposition.

    (b) Each Regulated Fund will have the right to participate in such disposition on a proportionate basis, at the same price and on the same terms and conditions as those applicable to the participating Affiliated Funds and Regulated Funds.

    (c) A Regulated Fund may participate in such disposition without obtaining prior approval of the Required Majority if: (i) The proposed participation of each Regulated Fund and each Affiliated Fund in such disposition is proportionate to its outstanding investments in the issuer immediately preceding the disposition; (ii) the Board of the Regulated Fund has approved as being in the best interests of the Regulated Fund the ability to participate in such dispositions on a pro rata basis (as described in greater detail in the application); and (iii) the Board of the Regulated Fund is provided on a quarterly basis with a list of all dispositions made in accordance with this condition. In all other cases, the Adviser will provide its written recommendation as to the Regulated Fund's participation to the Eligible Directors, and the Regulated Fund will participate in such disposition solely to the extent that a Required Majority determines that it is in the Regulated Fund's best interests.

    (d) Each Affiliated Fund and each Regulated Fund will bear its own expenses in connection with any such disposition.

    8.

    (a) If any Affiliated Fund or Regulated Fund desires to make a Follow-On Investment in a portfolio company whose securities were acquired in a Co-Investment Transaction, the applicable Advisers will:

    (i) Notify each Regulated Fund that participated in the co-investment transaction of the proposed Follow-On Investment at the earliest practical time; and

    (ii) formulate a recommendation as to the proposed participation, including the amount of the proposed Follow-On Investment, by each Regulated Fund.

    (b) A Regulated Fund may participate in such Follow-On Investment without obtaining prior approval of the Required Majority if: (i) The proposed participation of each Regulated Fund and each Affiliated Fund in such investment is proportionate to its outstanding investments in the issuer immediately preceding the Follow-On Investment; and (ii) the Board of the Regulated Fund has approved as being in the best interests of the Regulated Fund the ability to participate in Follow-On Investments on a pro rata basis (as described in greater detail in the application). In all other cases, the Adviser will provide its written recommendation as to the Regulated Fund's participation to the Eligible Directors, and the Regulated Fund will participate in such Follow-On Investment solely to the extent that a Required Majority determines that it is in the Regulated Fund's best interests.

    (c) If, with respect to any Follow-On Investment:

    (i) The amount of the opportunity is not based on the Regulated Funds' and the Affiliated Funds' outstanding investments immediately preceding the Follow-On Investment; and

    (ii) the aggregate amount recommended by the applicable Adviser to be invested by the applicable Regulated Fund in the Follow-On Investment, together with the amount proposed to be invested by other participating Regulated Funds and Affiliated Funds, collectively, in the same transaction, exceeds the amount of the investment opportunity, then the investment opportunity will be allocated among them pro rata based on each participant's Available Capital, up to the amount proposed to be invested by each.

    (d) The acquisition of Follow-On Investments as permitted by this condition will be considered a Co-Investment Transaction for all purposes and subject to the other conditions set forth in the application.

    9. The Non-Interested Directors of each Regulated Fund will be provided quarterly for review all information concerning Potential Co-Investment Transactions and Co-Investment Transactions, including investments made by any other Regulated Funds or Affiliated Funds that the Regulated Fund considered but declined to participate in, so that the Non-Interested Directors may determine whether all investments made during the preceding quarter, including those investments that the Regulated Fund considered but declined to participate in, comply with the conditions of the Order. In addition, the Non-Interested Directors will consider at least annually the continued appropriateness for the Regulated Fund of participating in new and existing Co-Investment Transactions.

    10. Each Regulated Fund will maintain the records required by section 57(f)(3) of the Act as if each of the Regulated Funds were a BDC and each of the investments permitted under these conditions were approved by the Required Majority under section 57(f) of the Act.

    11. No Non-Interested Director of a Regulated Fund will also be a director, general partner, managing member or principal, or otherwise an “affiliated person” (as defined in the Act) of an Affiliated Fund.

    12. The expenses, if any, associated with acquiring, holding or disposing of any securities acquired in a Co-Investment Transaction (including, without limitation, the expenses of the distribution of any such securities registered for sale under the 1933 Act) will, to the extent not payable by the Advisers under their respective investment advisory agreements with Affiliated Funds and the Regulated Funds, be shared by the Regulated Funds and the Affiliated Funds in proportion to the relative amounts of the securities held or to be acquired or disposed of, as the case may be.

    13. Any transaction fee 10 (including break-up or commitment fees but excluding broker's fees contemplated section 17(e) or 57(k) of the Act, as applicable) received in connection with a Co-Investment Transaction will be distributed to the participating Regulated Funds and Affiliated Funds on a pro rata basis based on the amounts they invested or committed, as the case may be, in such Co-Investment Transaction. If any transaction fee is to be held by an Adviser pending consummation of the Co-Investment Transaction, the fee will be deposited into an account maintained by such Adviser at a bank or banks having the qualifications prescribed in section 26(a)(1) of the Act, and the account will earn a competitive rate of interest that will also be divided pro rata among the participating Regulated Funds and Affiliated Funds based on the amounts they invest in such Co-Investment Transaction. None of the Affiliated Funds, the Advisers, the other Regulated Funds, or any affiliated person of the Regulated Funds or Affiliated Funds will receive additional compensation or remuneration of any kind as a result of or in connection with a Co-Investment Transaction (other than (a) in the case of the Regulated Funds and the Affiliated Funds, the pro rata transaction fees described above and fees or other compensation described in condition 2(c)(iii)(C); and (b) in the case of an Adviser, investment advisory fees paid in accordance with the investment advisory agreements between such Adviser and the Regulated Fund or Affiliated Fund).

    10 The Applicants are not requesting, and the staff is not providing, any relief for transaction fees received in connection with any Co-Investment Transaction.

    14. If the Holders own in the aggregate more than 25% of the Shares of a Regulated Fund, then the Holders will vote such Shares as directed by an independent third party when voting on (1) the election of directors; (2) the removal of one or more directors; or (3) any other matter under either the Act or applicable state law affecting the Board's composition, size or manner of election.

    15. Each Regulated Fund's chief compliance officer, as defined in rule 38a-1(a)(4) under the Act, will prepare an annual report for the Board of such Regulated Fund that evaluates (and documents the basis of that evaluation) the Regulated Fund's compliance with the terms and conditions of the application and procedures established to achieve such compliance.

    For the Commission, by the Division of Investment Management, under delegated authority.

    Eduardo A. Aleman, Assistant Secretary.
    [FR Doc. 2018-22676 Filed 10-17-18; 8:45 am] BILLING CODE 8011-01-P
    SECURITIES AND EXCHANGE COMMISSION [Release No. 34-84417; File No. SR-MIAX-2018-14] Self-Regulatory Organizations; Miami International Securities Exchange, LLC; Order Granting Approval of a Proposed Rule Change To List and Trade Options on the SPIKESTM Index October 12, 2018. I. Introduction

    On June 28, 2018, Miami International Securities Exchange, LLC (“MIAX Options” or “Exchange”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),1 and Rule 19b-4 thereunder,2 a proposed rule change to list and trade options on the SPIKESTM Index (“SPIKES” or the “Index”), which measures expected 30-day volatility of the SPDR S&P 500 ETF Trust (“SPY”). The proposed rule change was published for comment in the Federal Register on July 16, 2018.3 On August 28, 2018, 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 approve or disapprove the proposed rule change.5 The Commission received no comments on the proposal. 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. 83619 (July 11, 2018), 83 FR 32932 (“Notice”).

    4 15 U.S.C. 78s(b)(2).

    5See Securities Exchange Act Release No. 83975, 83 FR 44929 (September 4, 2018). The Commission designated October 14, 2018 as the date by which the Commission shall approve or disapprove, or institute proceedings to determine whether to approve or disapprove, the proposed rule change.

    II. Description of the Proposed Rule Change

    The Exchange proposes to list and trade cash-settled, European-style options on the Index, which measures expected thirty-day volatility of SPY.6

    6 According to the Exchange, SPY is historically the largest and most actively-traded exchange-traded fund in the United States as measured by its assets under management and the value of shares traded. See Notice, supra note 3, at 32936.

    As more fully set forth in the Notice, the Index is calculated using a methodology developed by T3i Pty Ltd, which uses published real-time prices and bid/ask quotes of SPY options.7 The Index will be calculated and maintained by the Exchange. The Index uses a proprietary “price dragging” technique to determine the ongoing price for each individual option used in the calculation of the Index (“Reference Price”), which the Exchange believes should materially reduce erratic movements of the Index value as quotations on out-of-the-money options are rapidly altered during times of low liquidity.8 The Exchange also notes the Index's exclusion rule (“truncation method”), which determines how far away from the money to exclude strikes from the volatility calculation. When two consecutive option prices of $0.05 or less are encountered when moving away from the at-the-money strike, the truncation method excludes all the strikes beyond that level, from each of the put and call side.9 The Exchange believes that this exclusion methodology should result in a calculation outcome that better reflects the expected measure of volatility.10

    7See id. at 32933-36 (describing in more detail the calculation methodology for the Index).

    8See id. at 32934-35 (describing in more detail the “price dragging” methodology).

    9See id. at 32935 (describing in more detail the truncation method).

    10See id.

    The Index will be updated on a real-time basis on each trading day beginning at 9:30 a.m. and ending at 4:15 p.m. (New York time).11 Values of the Index will be disseminated to the Options Price Reporting Authority (“OPRA”) at least every fifteen seconds during the Exchange's regular trading hours, pursuant to Exchange Rules 1802 and 1803.12 In the event the Index ceases to be maintained or calculated, or its values are not disseminated at least every fifteen seconds by a widely available source, the Exchange will not list any additional series for trading and may, for the purpose of maintaining a fair and orderly market and protecting investors, limit transactions in certain options on the Index to closing transactions only.

    11 If the current published value of a component is not available, the last published value will be used in the calculation.

    12 The Exchange notes that it is currently disseminating the cash values of the Index to OPRA under the ticker symbol “SPIKE” in at least fifteen second intervals. See Notice, supra note 3, at 32936.

    The Exchange proposes that the standard trading hours for index options (9:30 a.m. to 4:15 p.m., New York time) will apply to options on the Index. Options on the Index will expire on the Wednesday that is thirty days prior to the third Friday of the calendar month immediately following the expiration month.13 The exercise-settlement amount will be equal to the difference between the final settlement value of the Index and the exercise price of the option, multiplied by $100. Exercise will result in the delivery of cash on the business day following expiration.

    13 If that Wednesday or the Friday that is thirty days following that Wednesday is an Exchange holiday, the final settlement value will be calculated on the business day immediately preceding that Wednesday.

    To determine the final settlement value of the Index, the Exchange will perform an Index settlement price calculation, which includes all SPY options that expire thirty days after the SPIKES settlement that are included in the settlement (“constituent options”). To perform the Index settlement price calculation, each constituent option will be assigned a Settlement Reference Price (“SRP”). Each SRP will be determined through the proposed “SPIKES Special Settlement Auction,” which will be conducted once per month, in the constituent options traded on the Exchange, on final settlement day. The SPIKES Special Settlement Auction will utilize the Exchange's existing standard opening process, as described in Exchange Rule 503(f), with a proposed modification to account for situations where there remains an order imbalance 14 that must be filled at the opening price after the requisite number of iterations of the imbalance process takes place under the Exchange's existing opening process.15

    14 An “imbalance” occurs when there is insufficient liquidity to satisfy all trading interest due an execution at a certain price. See Exchange Rule 503(f)(2)(v).

    15 The proposed modification to the Exchange's existing opening process to facilitate the execution of this remaining must-fill interest is referred to as the special settlement imbalance process (“SSIP”). See proposed Rule 1809, Interpretation and Policy .06. For more detail about the operation of the SPIKES Special Settlement Auction, including an example, see Notice, supra note 3, at 32939-41.

    All orders for participation in the SPIKES Special Settlement Auction that are related to positions in, or a trading strategy involving, Index options (“SPIKES Strategy Orders”) and any change to or cancellation of any such order: (i) Must be received prior to the applicable SPIKES Strategy Order cut-off time for the constituent option series, as determined by the Exchange, which may be no earlier than the opening of the live order window (currently, 7:30 a.m.) or the live quote window (for the SPIKES Special Settlement Auction, anticipated to be 8:30 a.m.), and no later than the opening of trading in the series; and (ii) may not be cancelled or modified after the applicable SPIKES Strategy Order cut-off time, unless the SPIKES Strategy Order is not executed in the SPIKES Special Settlement Auction and the cancellation or modification is submitted after the SPIKES Special Settlement Auction is concluded. The Exchange states that it will generally consider orders to be SPIKES Strategy Orders if the orders possess the following characteristics: (i) They are for options with the expiration that will be used to calculate the exercise or final settlement value of the applicable volatility index option contract; (ii) they are for options spanning the full range of strike prices for the appropriate expiration for options that will be used to calculate the exercise or final settlement value of the applicable volatility index option contract, but not necessarily every available strike price; and (iii) they are for put options with strike prices less than the at-the-money strike price, for call options with strike prices greater than the at-the-money strike price, or for put and call options with at-the-money strike prices. The Exchange notes that it may also deem order types other than those provided above as SPIKES Strategy Orders if the Exchange determines that to be the case based on the applicable facts and circumstances.16

    16See Notice, supra note 3, at 32939.

    The Exchange believes that the Index, including the settlement value, will not be readily susceptible to manipulation.17 According to the Exchange, the “price dragging” technique, which is used to determine the ongoing Reference Price for each individual option used in the calculation of the Index, helps prevent market manipulation by utilizing the most recent trade price as the Reference Price, which the Exchange believes to be a more accurate methodology than alternatives.18 Further, the Exchange believes that using SPY options as the components for a volatility index has the potential to result in an extremely liquid volatility product with exceptionally tight spreads, which consequently would not be readily susceptible to fraudulent and manipulative acts.19 For example, the Exchange notes that SPY options regularly trade four to five million contracts a day and have twenty to thirty million contracts in open interest, and are traded on all fifteen option exchanges.20 Since SPY options are traded on all fifteen option exchanges, the Exchange believes that market participants may take advantage of arbitrage opportunities across multiple venues.21

    17See id. at 32942-43.

    18See id. at 32942.

    19See id. at 32943.

    20See id.

    21See id.

    The Exchange proposes to adopt minimum trading increments for options on the Index to be $0.05 for series trading below $3, and $0.10 for series trading at or above $3. The Exchange also proposes to set the minimum strike price interval for options on the Index at $0.50 where the strike price is less than $15, $1 or greater where the strike price is between $15 and $200, and $5 or greater where the strike price is greater than $200. Currently, when new series of options on the Index with a new expiration date are opened for trading, or when additional series of options on the Index in an existing expiration date are opened for trading as the current value of the Index moves substantially from the exercise prices of series already opened, the exercise prices of such new or additional series must be reasonably related to the current value of the Index at the time such series are first opened for trading.22 The Exchange, however, proposes to eliminate this range limitation that would otherwise limit the number of $1 strikes that may be listed in options on the Index. The Exchange's proposal to eliminate this range limitation is identical to strike price intervals adopted by the Cboe Exchange, Inc. (“Cboe”) for the Cboe Volatility Index (“VIX”).23

    22See Exchange Rule 1809(c)(3). The term “reasonably related to the current index value of the underlying index” means that the exercise price is within thirty percent of the current index value, as defined in Exchange Rule 1809(c)(4).

    23See Securities Exchange Act Release No. 63155 (October 21, 2010), 75 FR 66402 (October 28, 2010) (SR-CBOE-2010-096).

    The Exchange initially proposes to list options on the Index in up to twelve standard monthly expirations. In addition, long-term option series having up to sixty months to expiration,24 Short Term Option Series,25 and Quarterly Options Series 26 may also be traded. Options on the Index will be quoted and traded in U.S. dollars.27

    24See Exchange Rule 1809(b)(1).

    25See Exchange Rule 1809, Interpretations and Policies .01.

    26See Exchange Rule 1809, Interpretations and Policies .02.

    27See Exchange Rule 1809(a)(1).

    The Exchange believes that the Index is a broad-based index, as that term is defined in Exchange Rule 1801(k).28 The Exchange proposes that the Index should be treated as a broad-based index for purposes of position limits, exercise limits, and margin requirements. Accordingly, the Exchange proposes no position or exercise limits for options on the Index 29 and the Exchange proposes to apply margin requirements that are identical to those applied for other broad-based index options.

    28 Exchange Rule 1801(k) defines the terms “market index” and “broad-based index” to mean an index designed to be representative of a stock market as a whole or of a range of companies in unrelated industries.

    29 As noted above, the Index will settle using published prices and quotes from its corresponding SPY options. The Exchange asserts that because the size of SPY options market (as well as the underlying SPY market) is so large, the Exchange believes that there is minimal risk of manipulation by virtue of position size in SPIKES options. The Exchange notes that options on Cboe's VIX are also not subject to any position or exercise limits. See Notice, supra note 3, at 32941. See also Securities Exchange Act Release No. 54019 (June 20, 2006), 71 FR 36569 (June 27, 2006) (SR-CBOE-2006-55). Additionally, the Exchange notes there are currently a number of actively-traded broad-based index options, e.g., DJX, NDX, SPX, that are also not subject to any position or exercise limits. See Notice, supra note 3, at 32941 n.56.

    In addition, the Exchange proposes that the trading of options on the Index will be subject to the same rules governing the trading of Exchange index options, including sales practice rules, margin requirements, and trading rules. Trading of options on the Index will also be subject to the trading halt procedures applicable to other index options traded on the Exchange.30 Further, Chapter XIII of the Exchange's rules, which is designed to protect public customer trading, will apply to trading in options on the Index.

    30See Exchange Rule 1808(c).

    The Exchange represents that it has an adequate surveillance program in place for options on the Index and intends to apply those same program procedures that it applies to the Exchange's other options products. In addition, the Exchange notes that several new surveillances related to the Index will be added to its surveillance program.31 Specifically, the Exchange notes that it has a Regulatory Services Agreement (“RSA”) in place with the Financial Industry Regulatory Authority (“FINRA”) to conduct cross-market surveillances on its behalf and has expanded the RSA to include a new options pattern designed to determine whether any market participants influenced the settlement price of an a.m. cash-settled index product to benefit their expiring index option position. Further, the Exchange represents that both MIAX Options Regulation and FINRA Options Regulation will manually review options activity during each monthly settlement process. After manually reviewing settlement process activity over the course of months, the Exchange and FINRA will determine whether additional reports or enhancements to the cash-settled report(s) are required.32 Additionally, the Exchange notes that it is a member of the Intermarket Surveillance Group, through which it can coordinate surveillance and investigative information sharing in the stock and options markets with all U.S. registered stock and options markets. The Exchange also represents that it has the necessary system capacity to support additional quotations and messages that will result from the listing and trading of options on the Index.

    31See Notice, supra note 3, at 32942.

    32See id.

    III. Discussion and Commission Findings

    After careful consideration of the proposal, 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,33 and, in particular, the requirements of Section 6 of the Act.34 Specifically, the Commission finds that the proposed rule change is consistent with Section 6(b)(5) of the Act,35 which requires, among other things, that the rules of a national securities exchange 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. Specifically, the Commission believes that the proposed Index options provide investors with an additional trading and hedging mechanism.

    33 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).

    34 15 U.S.C. 78f.

    35 15 U.S.C. 78f(b)(5).

    The Commission believes that the Exchange's proposal is consistent with the Act.36 As noted above, the Index is calculated using published real-time price and bid/ask quotes of SPY options and measures changes in the expected thirty-day volatility of SPY. The Commission notes that SPY options are the most actively-traded options in terms of average daily volume. After careful consideration, the Commission has determined that the Exchange's proposal to list and trade options on the Index, including the proposed settlement process, is comparable to the listing and trading of options on similar volatility indexes.37

    36 In approving this proposed rule change to list and trade options on the Index, the Commission is not determining whether the Index is a “narrow-based” security index as that term is defined in the Act. See 15 U.S.C. 78c(a)(55)(B).

    37See Securities Exchange Act Release No. 49563 (April 14, 2004), 69 FR 21589 (April 21, 2004) (SR-CBOE-2003-40) (order approving the listing and trading of options on the VIX). See also Securities Exchange Act Release No. 71365 (January 22, 2014), 79 FR 4512 (January 28, 2014) (SR-ISE-2013-42) (order approving the listing and trading of options on the Nations VolDex Index).

    The Commission also believes that permitting $0.50 strike price intervals if the strike price is less than $15 and $1.00 strike price intervals if the strike price is between $15 and $200 will provide investors with added flexibility in the trading of these options and will further the public interest by allowing investors to establish positions that are better tailored to meet their investment objectives. As noted above, the Exchange proposes to provide an exception for the proposed Index options from the existing requirement that exercise prices of new or additional series must be reasonably related to the current value of the Index at the time such series are first opened for trading.38 The Commission believes that this change is consistent with the Act because it should provide investors added flexibility to meet their investment objectives.39 The Commission also notes that the Exchange has represented that it has the necessary systems capacity to handle the additional traffic associated with the listing and trading of this new product and it expects that the Exchange considered this expansion of the permissible range of strike prices in making such a representation.40

    38See supra notes 22-23 and accompanying text.

    39 The Commission notes that Cboe previously eliminated the band that limited the number of $1 strikes that could be listed on VIX options. See Securities Exchange Act Release No. 63155 (October 21, 2010), 75 FR 66402 (October 28, 2010) (SR-CBOE-2010-096).

    40See Notice, supra note 3, at 32942.

    The Commission also believes that it is consistent with the Act to apply margin requirements to the proposed Index options that are otherwise applicable to options on broad-based indexes. The Commission further believes that the Exchange's proposed minimum trading increment, series openings, and other aspects of the proposed rule change are appropriate and consistent with the Act.

    As a national securities exchange, the Exchange is required, under Section 6(b)(1) of the Act,41 to enforce compliance by its members and persons associated with its members with the provisions of the Act, Commission rules and regulations thereunder, and its own rules. The Exchange has asserted its belief that there is a low potential for manipulation of the Index settlement value.42 The Exchange has represented that it has an adequate surveillance program in place for options traded on the Index, and will monitor for any potential manipulation of the Index settlement value according to its current surveillance procedures and additional surveillance measures.43 The Commission also notes the Exchange's representation that it has the necessary systems capacity to support the new options series that will result from this proposal.44

    41 15 U.S.C. 78f(b)(1).

    42See Notice, supra note 3, at 32942-43.

    43See supra notes 31-32 and accompanying text.

    44See id.

    IV. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the Act,45 that the proposed rule change (SR-MIAX-2018-14) be, and hereby is, approved.

    45 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.46

    46 17 CFR 200.30-3(a)(12).

    Eduardo A. Aleman, Assistant Secretary.
    [FR Doc. 2018-22683 Filed 10-17-18; 8:45 am] BILLING CODE 8011-01-P
    SMALL BUSINESS ADMINISTRATION [Disaster Declaration #15696 and #15697; North Carolina Disaster Number NC-00099] Presidential Declaration Amendment of a Major Disaster for the State of North Carolina AGENCY:

    U.S. Small Business Administration.

    ACTION:

    Amendment 4.

    SUMMARY:

    This is an amendment of the Presidential declaration of a major disaster for the State of North Carolina (FEMA-4393-DR), dated 09/14/2018.

    Incident: Hurricane Florence.

    Incident Period: 09/07/2018 through 09/29/2018.

    DATES:

    Issued on 10/10/2018.

    Physical Loan Application Deadline Date: 11/13/2018.

    Economic Injury (EIDL) Loan Application Deadline Date: 06/14/2019.

    ADDRESSES:

    Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.

    FOR FURTHER INFORMATION CONTACT:

    A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW, Suite 6050, Washington, DC 20416, (202) 205-6734.

    SUPPLEMENTARY INFORMATION:

    The notice of the President's major disaster declaration for the State of North Carolina, dated 09/14/2018, is hereby amended to establish the incident period for this disaster as beginning 09/07/2018 and continuing through09/29/2018.

    All other information in the original declaration remains unchanged.

    (Catalog of Federal Domestic Assistance Number 59008) James Rivera, Associate Administrator for Disaster Assistance.
    [FR Doc. 2018-22691 Filed 10-17-18; 8:45 am] BILLING CODE 8025-01-P
    SMALL BUSINESS ADMINISTRATION [Disaster Declaration #15624 and #15625; California Disaster Number CA-00292] Presidential Declaration Amendment of a Major Disaster for Public Assistance Only for the State of California AGENCY:

    U.S. Small Business Administration.

    ACTION:

    Amendment 2.

    SUMMARY:

    This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the State of California (FEMA-4382-DR), dated 08/04/2018.

    Incident: Wildfires and High Winds.

    Incident Period: 07/23/2018 through 09/19/2018.

    DATES:

    Issued on 10/04/2018.

    Physical Loan Application Deadline Date: 10/03/2018.

    Economic Injury (EIDL) Loan Application Deadline Date: 05/06/2019.

    ADDRESSES:

    Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.

    FOR FURTHER INFORMATION CONTACT:

    A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW, Suite 6050, Washington, DC 20416, (202) 205-6734.

    SUPPLEMENTARY INFORMATION:

    The notice of the President's major disaster declaration for Private Non-Profit organizations in the State of California, dated 08/04/2018, is hereby amended to include the following areas as adversely affected by the disaster.

    Primary Counties: Lake

    All other information in the original declaration remains unchanged.

    (Catalog of Federal Domestic Assistance Number 59008) James Rivera, Associate Administrator for Disaster Assistance.
    [FR Doc. 2018-22693 Filed 10-17-18; 8:45 am] BILLING CODE 8025-01-P
    SURFACE TRANSPORTATION BOARD [Docket No. AB 303 (Sub-No. 50X)] Wisconsin Central Ltd.—Discontinuance of Service Exemption—in Ashland and Price Counties, Wis.

    Wisconsin Central Ltd. (WCL) has filed a verified notice of exemption under 49 CFR pt. 1152 subpart F—Exempt Abandonments and Discontinuances of Service to discontinue service over a portion of WCL's Ashland Subdivision extending approximately 58.4 miles from milepost 434.4 in the city of Ashland, Ashland County, Wis., to milepost 376.0 near Park Falls, Price County, Wis. (the Line). The Line traverses United States Postal Service Zip Codes 54806, 54855, 54846, 54546, 54527, 54514, and 54552.

    WCL has certified that: (1) No local traffic has moved over the Line for at least two years; (2) there is no overhead traffic to be rerouted over other lines; (3) no formal complaint filed by a user of a rail service on the Line (or by a state or local government entity acting on behalf of such user) regarding cessation of service over the Line is either pending with the Surface Transportation Board (Board) or with any U.S. District Court or has been decided in favor of a complainant within the two-year period; and (4) the requirements at 49 CFR 1105.12 (newspaper publication) and 49 CFR 1152.50(d)(1) (notice to governmental agencies) have been met.

    As a condition to this exemption, any employee adversely affected by the discontinuance of service shall be protected under Oregon Short Line Railroad—Abandonment Portion Goshen Branch Between Firth & Ammon, in Bingham & Bonneville Counties, Idaho, 360 I.C.C. 91 (1979). To address whether this condition adequately protects affected employees, a petition for partial revocation under 49 U.S.C. 10502(d) must be filed.

    Provided no formal expression of intent to file an offer of financial assistance (OFA) 1 to subsidize continued rail service has been received, this exemption will be effective on November 17, 2018, unless stayed pending reconsideration. Formal expressions of intent to file an OFA to subsidize continued rail service under 49 CFR 1152.27(c)(2) 2 must be filed by October 26, 2018. Petitions to stay that do not involve environmental issues must be filed by October 29, 2018.3 Petitions for reconsideration must be filed by November 7, 2018, with the Surface Transportation Board, 395 E Street SW, Washington, DC 20423-0001.

    1 The Board modified its OFA procedures effective July 29, 2017. Among other things, the OFA process now requires potential offerors, in their formal expression of intent, to make a preliminary financial responsibility showing based on a calculation using information contained in the carrier's filing and publicly available information. See Offers of Financial Assistance, EP 729 (STB served June 29, 2017); 82 FR 30 997 (July 5, 2017).

    2 Each OFA must be accompanied by the filing fee, which currently is set at $1,800. See 49 CFR 1002.2(f)(25).

    3 Because this is a discontinuance proceeding and not an abandonment, trail use/rail banking and public use conditions are not appropriate. Because there will be an environmental review during abandonment, this discontinuance does not require environmental review.

    A copy of any petition filed with Board should be sent to WCL's representative, Bradon J. Smith, Fletcher & Sippel LLC, 29 North Wacker Drive, Suite 800, Chicago, IL 60606.

    If the verified notice contains false or misleading information, the exemption is void ab initio.

    Board decisions and notices are available on our website at www.stb.gov.

    Decided: October 15, 2018.

    By the Board, Scott M. Zimmerman, Acting Director, Office of Proceedings.

    Brendetta Jones, Clearance Clerk.
    [FR Doc. 2018-22739 Filed 10-17-18; 8:45 am] BILLING CODE 4915-01-P
    DEPARTMENT OF TRANSPORTATION Federal Motor Carrier Safety Administration [Docket No. FMCSA-2018-0236] Hours of Service of Drivers: Rota-Mill, Inc.; Application for Exemption AGENCY:

    Federal Motor Carrier Safety Administration (FMCSA), DOT.

    ACTION:

    Notice of application for exemption; request for comments.

    SUMMARY:

    FMCSA announces that it has received an application from Rota-Mill, Inc. (Rota-Mill) requesting exemptions from two requirements of the hours-of-service (HOS) regulations for drivers of commercial motor vehicles (CMVs): (1) The 30-minute rest break provision and (2) the requirement that short-haul drivers utilizing the record of duty status (RODS) exception return to their work-reporting location within 12 hours of coming on duty. The first exemption would enable drivers engaged in the transportation of milled asphalt and related materials and equipment to use 30 minutes or more of on-duty “waiting time” at a jobsite to satisfy the requirement for the 30-minute rest break, provided they do not perform any other work during the break. The second exemption would allow these drivers to use the short-haul exception, but return to their work-reporting location within 14 hours instead of the current 12 hours. FMCSA requests public comment on Rota-Mill's application for exemptions.

    DATES:

    Comments must be received on or before November 19, 2018.

    ADDRESSES:

    You may submit comments identified by Federal Docket Management System Number FMCSA-2018-0236 by any of the following methods:

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

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

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

    Fax: 1-202-493-2251.

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

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

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

    FOR FURTHER INFORMATION CONTACT:

    For information concerning this notice, please contact Mr. Richard Clemente, FMCSA Driver and Carrier Operations Division; Telephone: (202) 366-2722; Email: [email protected] If you have questions on viewing or submitting material to the docket, contact Docket Services, telephone (202) 366-9826.

    SUPPLEMENTARY INFORMATION:

    I. Public Participation and Request for Comments

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

    Submitting Comments

    If you submit a comment, please include the docket number for this notice (FMCSA-2018-0236), indicate the specific section of this document to which the comment applies, and provide a reason for suggestions or recommendations. You may submit your comments and material online or by fax, mail, or hand delivery, but please use only one of these means. FMCSA recommends that you include your name and a mailing address, an email address, or a phone number in the body of your document so the Agency can contact you if it has questions regarding your submission.

    To submit your comment online, go to www.regulations.gov and put the docket number, “FMCSA-2018-0236” in the “Keyword” box, and click “Search.” When the new screen appears, click on “Comment Now!” button and type your comment into the text box in the following screen. Choose whether you are submitting your comment as an individual or on behalf of a third party and then submit. If you submit your comments by mail or hand delivery, submit them in an unbound format, no larger than 81/2 by 11 inches, suitable for copying and electronic filing. If you submit comments by mail and would like to know that they reached the facility, please enclose a stamped, self-addressed postcard or envelope. FMCSA will consider all comments and material received during the comment period and may grant or not grant this application based on your comments.

    II. Legal Basis

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

    The Agency reviews safety analyses and public comments submitted, and determines whether granting the exemption would likely achieve a level of safety equivalent to, or greater than, the level that would be achieved by the current regulation (49 CFR 381.305). The decision of the Agency must be published in the Federal Register (49 CFR 381.315(b)) with the reasons for denying or granting the application and, if granted, the name of the person or class of persons receiving the exemption, and the regulatory provision from which the exemption is granted. The notice must also specify the effective period (up to 5 years) and explain the terms and conditions of the exemption. The exemption may be renewed (49 CFR 381.300(b)).

    III. Request for Exemption

    Rota-Mill seeks exemptions for all of its drivers transporting milled asphalt and related materials and equipment from the HOS 30-minute rest break provision in 49 CFR 395.3(a)(3)(ii) and the restriction of the RODS exception for short-haul operations to drivers who return to their normal work-reporting location within 12 hours [49 CFR 395.1(e)(1)(ii)(A)].

    Rota-Mill employs approximately 21 commercial driver's license holders who are the operators of the heavy equipment. They drive to the job location, then operate the equipment they deliver. Their driving time for any given day would be less than 5 hours. A considerable amount of Rota-Mill's jobs are between one and one-and-a-half hours away. If the job is for 8 hours, these drivers can easily return to Rota-Mill's facility within the 12-hour limit of the short-haul exception in 395.1(e). The issue arises when Rota-Mill's crews arrive on a job, and the job increases in size as a result of some unforeseen circumstance. In this case, the Rota-Mill drivers are sometimes required to work longer than 12 hours.

    The first exemption from the HOS rest break provision, if granted, would enable drivers engaged in the transportation of milled asphalt and related materials to use 30 minutes or more of on-duty “waiting time” to satisfy the requirement for the 30-minute rest break, provided they do not perform any other work during the break. This would apply when the drivers are not eligible for the short-haul exception. According to Rota-Mill, the requirement for the 30-minute break after the first 8 hours on duty is difficult for their drivers, because the time actually driving a CMV is typically only a few hours per day, with the rest of the day assigned to some other task. Rota-Mill dump truck operators are required to wait at quarries and various other locations, and cannot get out of line to take their required 30-minute break. Extending the short-haul exception without the 30-minute mandatory break would help make Rota-Mill's system run more efficiently and ultimately be safer.

    The second exemption, if granted, would allow these same drivers to use the short-haul RODS exception but with a 14-hour duty period instead of 12 hours. Rota-Mill advises that providing the requested relief would allow all of their drivers to get home in a compliant amount of time without the burden of having to maintain a full record of duty status or taking the currently required 30-minute break if they exceed the 12-hour work day. Additionally, granting these requested exemptions would ease confusion and provide clarity for Rota-Mill drivers who may mistakenly believe they are covered under the short-haul exception.

    Rota-Mill states in its application that drivers would receive sufficient rest due to the nature of their operations that limits driving to an average of six to seven hours per day or less during the road milling season. Rota-Mill believes that granting these exemptions would achieve the same level of safety provided by the two HOS rules. In an effort to ensure the same level of safety is maintained by complying with the regulations, Rota-Mill will add fatigue management training for its drivers. The requested exemptions are for 5 years. A copy of Rota-Mill's application for exemptions is available for review in the docket for this notice.

    Issued on: October 12, 2018. Larry W. Minor, Associate Administrator for Policy.
    [FR Doc. 2018-22703 Filed 10-17-18; 8:45 am] BILLING CODE 4910-EX-P
    DEPARTMENT OF TRANSPORTATION Federal Motor Carrier Safety Administration [Docket No. FMCSA-2018-0299] Hours of Service of Drivers: Application for Exemption; Fiat Chrysler Automobiles (FCA) AGENCY:

    Federal Motor Carrier Safety Administration (FMCSA), DOT.

    ACTION:

    Notice of application for exemption; request for comments.

    SUMMARY:

    FMCSA announces that Fiat Chrysler Automobiles (FCA) has requested an exemption from the requirement that a motor carrier install and require each of its drivers to use an electronic logging device (ELD) to record the driver's hours-of-service (HOS). FCA has requested a two-year exemption for all its operators of commercial motor vehicles (CMVs) including engineers, technicians, and other drivers who operate CMVs on public roads. FCA's product development activities encompass working with suppliers on validating engineering redesigns for future vehicles, and they estimate that 85% to 90% of such testing occurs on-site at its facilities. The remaining testing occurs off-site on public roads which is the reason FCA is requesting the exemption from the ELD regulations. FCA believes that granting this exemption will have no adverse safety impacts while its CMV operators are performing product development on off-site public road trips. FMCSA requests public comment on FCA's application for exemption.

    DATES:

    Comments must be received on or before November 19, 2018.

    ADDRESSES:

    You may submit comments identified by Federal Docket Management System (FDMS) Number FMCSA-2018-0299 by any of the following methods:

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

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

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

    Fax: 1-202-493-2251.

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

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

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

    FOR FURTHER INFORMATION CONTACT:

    Mr. Richard Clemente, FMCSA Driver and Carrier Operations Division; Office of Carrier, Driver and Vehicle Safety Standards; Telephone: 202-366-2722. Email: [email protected] If you have questions on viewing or submitting material to the docket, contact Docket Services, telephone (202) 366-9826.

    SUPPLEMENTARY INFORMATION:

    I. Public Participation and Request for Comments

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

    Submitting Comments

    If you submit a comment, please include the docket number for this notice (FMCSA-2018-0299), indicate the specific section of this document to which the comment applies, and provide a reason for suggestions or recommendations. You may submit your comments and material online or by fax, mail, or hand delivery, but please use only one of these means. FMCSA recommends that you include your name and a mailing address, an email address, or a phone number in the body of your document so the Agency can contact you if it has questions regarding your submission.

    To submit your comments online, go to www.regulations.gov and put the docket number, “FMCSA-2018-0299” in the “Keyword” box, and click “Search.” When the new screen appears, click on “Comment Now!” button and type your comment into the text box in the following screen. Choose whether you are submitting your comment as an individual or on behalf of a third party, and then submit. If you submit your comments by mail or hand delivery, submit them in an unbound format, no larger than 81/2 by 11 inches, suitable for copying and electronic filing. If you submit comments by mail and would like to know that they reached the facility, please enclose a stamped, self-addressed postcard or envelope. FMCSA will consider all comments and material received during the comment period and may grant or not grant this application based on your comments.

    II. Legal Basis

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

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

    III. Request for Exemption

    FCA's CMVs include RAM trucks and other product families, which when configured with a trailer have a gross combination weight rating greater than 10,000 pounds. When operated in interstate commerce, this subjects the company and its drivers to the 49 CFR part 300-399 series of Federal regulations including the hours-of-service (HOS) rules. Procedures and processes are in place to ensure that only FCA and supplier employees with an active driver qualification file operate these vehicles. In any given year, up to 100 FCA employees may be involved in driving its CMVs on product development off-site road trips. All of its engineers and technicians are infrequent drivers who on average drive less than 2,500 miles/year on public roads. Additionally, all Engineering Groups conduct off-site road trips to evaluate systems and components to support future product development activities. Including non-CMV support vehicles, FCA normally sends between 8 to 12 vehicles with 4 to 5 trailers. This type of trip would include up to 20 drivers (engineers and technicians) who possess either a commercial driver's license or a chauffer's license. Most road trips involve a smaller number of vehicles and drivers, and according to FCA, a significant amount of testing occurs while the vehicles are stationary.

    FCA's product development activities encompass working with suppliers on validating engineering redesigns for future vehicles. FCA tests “next generation” vehicles against competing products from other original equipment manufacturers in dynamics settings. FCA estimates that 85% to 90% of such testing occurs on-site at its facilities or proving grounds, and the remaining testing occurs off-site on public roads. Specifically, FCA conducts tests to benchmark vehicles against competing brands, and some of these programs involve calibration and thermal validation of complete vehicle systems at various locations in the United States and Canada. On occasion, the instrumented vehicles and trailers are shipped to the off-site testing location, and on other occasions, FCA's engineers, technicians and suppliers drive these vehicles to the off-site test locations. None of its CMVs are involved in package delivery or passenger transportation.

    FCA has already tested several portable electronic logging device (ELD) units and found that the device interferes with the ability of their data loggers to capture high-speed data from vehicle control modules and networks for critical vehicle validation. Furthermore, the device causes the logger to suspend all message transmissions in error. As a result of its detailed investigations on this matter, FCA has concluded that utilizing paper records of duty status (RODS) and/or another HOS compliance application besides an ELD is the most effective and accurate method of measuring and reporting HOS that is compatible with its data loggers. FCA further includes a number of exhibits which demonstrate the problems described in the application when utilizing ELDs. The Company also includes HOS and other general compliance forms currently used to remain in compliance with the appropriate Federal Motor Carrier Safety Regulations.

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

    According to FCA, the granting of this exemption will have no negative impact on public safety or compliance with the HOS regulations. FCA takes the safety of its employees and the general public seriously. All product development off-site road trips are planned months in advance, and the participants, details of the testing protocol, routing and choice of lodgings are selected to maintain HOS compliance. Its employees have been using paper RODS to record HOS for the past five years. FCA utilizes print and on-line training tools to instruct its employees in CMV Driver Basics; Compliance, Safety, Accountability Know the Basics; Driver Vehicle and Road Side Inspections; and HOS Driver Training. FCA further recognizes that employees rotate annually between vehicle platforms and therefore conducts several safe driving workshops annually at its facilities to introduce and reinforce the following: Preparing to drive a CMV and driver fatigue; the basics of vehicle handling and safe braking with and without a trailer; truck-trailer backing skills including backing up an inclined road and parking; downhill braking techniques with ballasted trailers; and demonstration of proper truck/trailer connections (conventional, fifth wheel and gooseneck). All FCA attendees will have an opportunity to practice driving, parking and safe backing skills. FCA requests a two-year exemption from the ELD requirements in 49 CFR part 395 subpart B.

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

    Issued on: October 12, 2018. Larry W. Minor, Associate Administrator for Policy.
    [FR Doc. 2018-22701 Filed 10-17-18; 8:45 am] BILLING CODE 4910-EX-P
    DEPARTMENT OF TRANSPORTATION Federal Motor Carrier Safety Administration [Docket No. FMCSA-2018-0235] Hours of Service of Drivers: Wolfe House Movers, LLC and Wolfe House Movers of Indiana, LLC; Application for Exemption AGENCY:

    Federal Motor Carrier Safety Administration (FMCSA), DOT.

    ACTION:

    Notice of application for exemption; request for comments.

    SUMMARY:

    FMCSA announces that it has received a joint application from Wolfe House Movers, LLC and Wolfe House Movers of Indiana, LLC (Wolfe) requesting an exemption from the hours-of-service (HOS) regulations for drivers operating commercial motor vehicles (CMV) that transport steel beams and dollies to and from various job sites for lifting and moving buildings. Wolfe requests an exemption to use the 70-hour/8-day rule for its CMV operations although the company does not operate CMVs 7 days a week. FMCSA requests public comment on this application for exemption.

    DATES:

    Comments must be received on or before November 19, 2018.

    ADDRESSES:

    You may submit comments identified by Federal Docket Management System Number FMCSA-2018-0235 by any of the following methods:

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

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

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

    Fax: 1-202-493-2251.

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

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

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

    FOR FURTHER INFORMATION CONTACT:

    For information concerning this notice, please contact Ms. Pearlie Robinson, FMCSA Driver and Carrier Operations Division; Telephone: (202) 366-4225; Email: [email protected] If you have questions on viewing or submitting material to the docket, contact Docket Services, telephone (202) 366-9826.

    SUPPLEMENTARY INFORMATION:

    I. Public Participation and Request for Comments

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

    Submitting Comments

    If you submit a comment, please include the docket number for this notice (FMCSA-2018-0235), indicate the specific section of this document to which the comment applies, and provide a reason for suggestions or recommendations. You may submit your comments and material online or by fax, mail, or hand delivery, but please use only one of these means. FMCSA recommends that you include your name and a mailing address, an email address, or a phone number in the body of your document so the Agency can contact you if it has questions regarding your submission.

    To submit your comment online, go to www.regulations.gov and put the docket number, “FMCSA-2018-0235” in the “Keyword” box, and click “Search.” When the new screen appears, click on “Comment Now!” button and type your comment into the text box in the following screen. Choose whether you are submitting your comment as an individual or on behalf of a third party and then submit. If you submit your comments by mail or hand delivery, submit them in an unbound format, no larger than 81/2 by 11 inches, suitable for copying and electronic filing. If you submit comments by mail and would like to know that they reached the facility, please enclose a stamped, self-addressed postcard or envelope. FMCSA will consider all comments and material received during the comment period and may grant or not grant this application based on your comments.

    II. Legal Basis

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

    The Agency reviews safety analyses and public comments submitted, and determines whether granting the exemption would likely achieve a level of safety equivalent to, or greater than, the level that would be achieved by the current regulation (49 CFR 381.305). The decision of the Agency must be published in the Federal Register (49 CFR 381.315(b)) with the reasons for denying or granting the application and, if granted, the name of the person or class of persons receiving the exemption, and the regulatory provision from which the exemption is granted. The notice must also specify the effective period (up to 5 years) and explain the terms and conditions of the exemption. The exemption may be renewed (49 CFR 381.300(b)).

    III. Request for Exemption

    Wolfe House Movers, LLC (USDOT 1279267), and Wolfe House Movers of Indiana, LLC (USDOT 1679025) (Wolfe) seek an exemption from the HOS requirements of 49 CFR 395.3(b)(1) which prohibits a motor carrier from permitting or requiring a driver to drive a property-carrying CMV after the driver has been on duty 60 hours within a period of 7 consecutive days if the employing motor carrier does not operate CMVs every day of the week. Wolfe does not operate CMVs every day of the week and is prohibited from using the 70-hour/8-day rule in 49 CFR 395.3(b)(2) for its business operations.

    According to Wolfe, its primary line of business is lifting and moving buildings. Drivers employed by Wolfe transport steel beams and dollies to and from various jobsites where work is performed. Wolfe advises that its owners believe that Sunday is a day of rest and worship and refuse any business opportunities that would require Sunday work.

    Because Wolfe does not conduct business on Sunday, its commericial business operations are subject to the 60-hours-in-7-day rule set forth in 49 CFR 395.3(b)(1). Due to the geographical spread of its operations, Wolfe asserts that the 60 hour limitation is a substantial burden. Wolfe explained in its application that the company attempts to schedule work so that all crews can be at their home terminal before the 60th on-duty hour of the week. However, weather, traffic, or jobsite conditions sometimes delay completion of projects causing crews to be stranded one or two hours' drive from the home terminal. When delays occur relief drivers are sent in non-commercial vehicles to pick up stranded drivers so that the drivers who have run out of hours can drive back to the home terminal using the non-commercial vehicles while the relief drivers return the CMVs to the terminal.

    Wolfe reports that it is a small company and it is difficult to have relief drivers available on short notice and it is unproductive and costly for the company. Wolfe asserts that the stress and pressure associated with approaching the 60-hour cut-off is likely to have a detrimental effect on the safety performance of even well-trained and well-qualified drivers.

    According to Wolfe, allowing it to use the 70-hour/8-day HOS ruleset for all drivers not operating CMVs on Sundays would provide the following significant safety benefits:

    • The need for relief drivers would be significantly reduced or completely eliminated. This would result in fewer on-road miles driven (by eliminating the need for a relief driver to drive up to 100 miles out to pick up the CMV and for the regular driver to drive the non-CMV back the same 100 miles). This would also mean that the CMV would continue to be driven by the driver most familiar with it, rather than a part-time driver.

    • Drivers would be less stressed, knowing that they have sufficient time to complete their weekly schedule even if they are delayed by heavy traffic, weather conditions, etc.

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

    Issued on: October 12, 2018. Larry W. Minor, Associate Administrator for Policy.
    [FR Doc. 2018-22707 Filed 10-17-18; 8:45 am] BILLING CODE 4910-EX-P
    DEPARTMENT OF TRANSPORTATION Federal Motor Carrier Safety Administration [Docket No. FMCSA-2018-0302] Hours of Service of Drivers: Transco, Inc.; Application for Exemption AGENCY:

    Federal Motor Carrier Safety Administration (FMCSA), DOT.

    ACTION:

    Notice of application for exemption; request for comments.

    SUMMARY:

    FMCSA announces that it has received an application from Transco, Inc. (Transco) for an exemption from the 30-minute rest break provision of the Agency's hours-of-service (HOS) regulations for commercial motor vehicle (CMV) drivers. Transco requests that its drivers be permitted to comply with the 30-minute rest break requirement while performing on-duty, not-driving tasks. The requested exemption would apply to all Transco drivers in its grocery and food service divisions who make wholesale deliveries to grocery and convenience stores. Transco believes that the exemption, if granted, will achieve a level of safety equivalent to the level that would be achieved absent the exemption. FMCSA requests public comment on Transco's application for exemption.

    DATES:

    Comments must be received on or before November 19, 2018.

    ADDRESSES:

    You may submit comments identified by Federal Docket Management System (FDMS) Number FMCSA-2018-0302 by any of the following methods:

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

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

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

    Fax: 1-202-493-2251.

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

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

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

    FOR FURTHER INFORMATION CONTACT:

    Mr. Richard Clemente, FMCSA Driver and Carrier Operations Division; Office of Carrier, Driver and Vehicle Safety Standards; Telephone: (202) 366-2722; Email: [email protected] If you have questions on viewing or submitting material to the docket, contact Docket Services, telephone (202) 366-9826.

    SUPPLEMENTARY INFORMATION:

    I. Public Participation and Request for Comments

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

    Submitting Comments

    If you submit a comment, please include the docket number for this notice (FMCSA-2018-0302), indicate the specific section of this document to which the comment applies, and provide a reason for suggestions or recommendations. You may submit your comments and material online or by fax, mail, or hand delivery, but please use only one of these means. FMCSA recommends that you include your name and a mailing address, an email address, or a phone number in the body of your document so the Agency can contact you if it has questions regarding your submission.

    To submit your comment online, go to www.regulations.gov and put the docket number, “FMCSA-2018-0302” in the “Keyword” box, and click “Search.” When the new screen appears, click on “Comment Now!” button and type your comment into the text box in the following screen. Choose whether you are submitting your comment as an individual or on behalf of a third party and then submit. If you submit your comments by mail or hand delivery, submit them in an unbound format, no larger than 81/2 by 11 inches, suitable for copying and electronic filing. If you submit comments by mail and would like to know that they reached the facility, please enclose a stamped, self-addressed postcard or envelope. FMCSA will consider all comments and material received during the comment period.

    II. Legal Basis

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

    The Agency reviews safety analyses and public comments submitted, and determines whether granting the exemption would likely achieve a level of safety equivalent to, or greater than, the level that would be achieved by the current regulation (49 CFR 381.305). The decision of the Agency must be published in the Federal Register (49 CFR 381.315(b)) with the reasons for denying or granting the application and, if granted, the name of the person or class of persons receiving the exemption, and the regulatory provision from which the exemption is granted. The notice must also specify the effective period (up to 5 years) and explain the terms and conditions of the exemption. The exemption may be renewed (49 CFR 381.300(b)).

    III. Request for Exemption

    Transco seeks an exemption from the 30-minute rest break provision in 49 CFR 395.3(a)(3)(ii). Specifically, Transco requests an exemption that would allow its drivers to take a 30-minute on-duty, non-driving break in place of the 30-minute off-duty rest break currently required. McLane, Transco's parent company, is one of the nation's largest entities engaged in supply chain services, providing grocery and foodservice supply chain solutions for convenience stores, mass merchants, drug stores and restaurants throughout the United States. Approximately 3,580 Transco drivers would be eligible for the requested exemption. These drivers utilize approximately 1,700 CMVs in Transco's fleet, which consist almost exclusively of tractors equipped with sleeper berths, usually hauling 48 or 53-foot trailers. In most cases Transco's drivers operate in two-driver teams. Routes for these drivers include numerous, frequent stops to make deliveries of groceries to retailers. On these trips, Driver B goes directly into the sleeper berth at the beginning of the trip while Driver A conducts all pre-departure inspection requirements and then drives to the first delivery. This allows Driver B to delay starting his duty period until a time that is less than 14 hours from the work tour completion, thereby ensuring compliance with the 14-hour rule. Depending on travel times, Driver B usually starts working sometime between the first and third delivery stop. When Driver B comes out of the sleeper berth, he or she rides in the passenger seat while Driver A drives between stops. The two drivers have overlapping working tours and unload together at most stops in the middle of the trip. Until the end of Driver A's 14-hour duty period, the drivers may alternate driving and resting in the passenger seat between deliveries. Once Driver A reaches his or her 14-hour limit, Driver A will often go into the sleeper berth, but is allowed to remain on duty and perform non-driving activities. Therefore, at some point, usually when approximately one-half of the driving for a work tour has been completed, Driver B will take over driving duties and Driver A will sit in the passenger seat between stops. Since Driver B did not begin his or her duty period until exiting the sleeper berth, Driver B will have sufficient time available to drive during the rest of the work tour. Similarly, because Driver A ceases driving when approximately one-half of the work tour has been completed, he or she does not drive beyond the 14 hour on-duty window in which driving is permitted. Total trip time averages 17.2 hours. However, total driving time for both drivers combined averages just 9.1 hours. Each driver spends, on average, only 4.55 hours or 32.9% of their working tour engaged in driving, again much less than the 11 hours maximum time allowed.

    Transco contends that itsoperations are characterized by several factors that make the driving involved low risk and less susceptible to the type of fatigue associated with long-haul driving for the following reasons:

    • Transco's drivers operate largely on local roads at low speeds, which reduces fatigue risk. According to Transco, most drowsiness-related crashes occur at night in low-traffic conditions on rural interstates or other rural highways. By and large these conditions are the opposite of the conditions experienced by Transco's drivers, who spend most of their driving time on local roads at low speeds;

    • Its operations are characterized by multiple short driving periods interrupted by breaks, which precludes development of time-on-task fatigue and improves driver performance. Its drivers alternate between driving, unloading, and resting without spending significant continuous periods of time driving;

    • Its drivers have regular schedules and routes and return home after every trip. Approximately 85% of Transco's drivers work fixed schedules and routes with minimal trip-to-trip variations. Transco's trips begin and end at the same place.

    • Transco practices proactive safety management. In its application, Transco highlights several additional proactive safety management practices currently in place in connection with its grocery operations. These include DriveCam video monitoring; increased safety inspections and meetings; mandatory driver safety training; and manufacturer-installed collision avoidance systems on the vehicles.

    According to Transco, as a result of these operational differences, the 30-minute rest break requirement does not increase safety when applied to their drivers; instead, it claims the requirement may very well decrease road safety for its drivers. For the typical long-haul CMV driver, the 30-minute rest break serves as an opportunity to break the monotony of driving and relieve some of the stress of continuous driving, but Transco's drivers currently have breaks, which includes physical exercise, several times each day. Providing this exemption would in fact increase safety overall by reducing Transco's mileage exposure, and thus crash risk, by over 4 million additional miles per year.

    Transco believes that the requested exemption would achieve a level of safety that is equivalent to, or greater than, the level of safety that would be obtained by complying with the current regulation. Transco gives the following reasons why the Agency should approve the exemption request: (1) Allowing its drivers to substitute a 30-minute on-duty, non-driving break for a 30-minute off-duty break will not reduce safety; (2) No more than 50% of their logged time per working tour is “on-duty driving” time and the non-driving on-duty time is primarily devoted to pick-ups, deliveries and like operations; (3) They return to their point of origin at the end of their trip; (4) No driving is performed 14 hours after coming on duty; (5) Drivers do not drive if more than 8 hours have passed since the driver engaged in 30 consecutive minutes of on-duty non-driving activity; and, (6) The drivers operate CMVs equipped with electronic logging devices compliant with the Agency's regulations or compliant automatic on-board recorders for the period allowed for the use of such devices by FMCSA regulations.

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

    Issued on: October 12, 2018. Larry W. Minor, Associate Administrator for Policy.
    [FR Doc. 2018-22706 Filed 10-17-18; 8:45 am] BILLING CODE 4910-EX-P
    DEPARTMENT OF TRANSPORTATION Federal Motor Carrier Safety Administration [Docket No. FMCSA-2018-0271] Hours of Service of Drivers: RJR Transportation, Inc.; Application for Exemption AGENCY:

    Federal Motor Carrier Safety Administration (FMCSA), DOT.

    ACTION:

    Notice of application for exemption; request for comments.

    SUMMARY:

    FMCSA announces that it has received an application from RJR Transportation, Inc. (RJR) requesting an exemption to increase the 100 air-mile radius in “short-haul operations” to 150 air-miles for its drivers. This would enable the drivers not exceeding the 150 air-mile radius to utilize time records instead of a complete record of duty status (RODS) for that day. RJR believes that the exemption, if granted, will achieve a level of safety equivalent to the level that would be achieved absent the exemption. FMCSA requests public comment on RJR's application for exemption.

    DATES:

    Comments must be received on or before November 19, 2018.

    ADDRESSES:

    You may submit comments identified by Federal Docket Management System Number FMCSA-2018-0271 by any of the following methods:

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

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

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

    Fax: 1-202-493-2251.

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

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

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

    FOR FURTHER INFORMATION CONTACT:

    Mr. Richard Clemente, FMCSA Driver and Carrier Operations Division; Office of Carrier, Driver and Vehicle Safety Standards; Telephone: (202) 366-2722; Email: [email protected] If you have questions on viewing or submitting material to the docket, contact Docket Services, telephone (202) 366-9826.

    SUPPLEMENTARY INFORMATION:

    I. Public Participation and Request for Comments

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

    Submitting Comments

    If you submit a comment, please include the docket number for this notice (FMCSA-2018-0271), indicate the specific section of this document to which the comment applies, and provide a reason for suggestions or recommendations. You may submit your comments and material online or by fax, mail, or hand delivery, but please use only one of these means. FMCSA recommends that you include your name and a mailing address, an email address, or a phone number in the body of your document so the Agency can contact you if it has questions regarding your submission.

    To submit your comment online, go to www.regulations.gov and put the docket number, “FMCSA-2018-0271” in the “Keyword” box, and click “Search.” When the new screen appears, click on “Comment Now!” button and type your comment into the text box in the following screen. Choose whether you are submitting your comment as an individual or on behalf of a third party and then submit. If you submit your comments by mail or hand delivery, submit them in an unbound format, no larger than 81/2 by 11 inches, suitable for copying and electronic filing. If you submit comments by mail and would like to know that they reached the facility, please enclose a stamped, self-addressed postcard or envelope. FMCSA will consider all comments and material received during the comment period.

    II. Legal Basis

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

    The Agency reviews safety analyses and public comments submitted, and determines whether granting the exemption would likely achieve a level of safety equivalent to, or greater than, the level that would be achieved by the current regulation (49 CFR 381.305). The decision of the Agency must be published in the Federal Register (49 CFR 381.315(b)) with the reasons for denying or granting the application and, if granted, the name of the person or class of persons receiving the exemption, and the regulatory provision from which the exemption is granted. The notice must also specify the effective period (up to 5 years) and explain the terms and conditions of the exemption. The exemption may be renewed (49 CFR 381.300(b)).

    III. Request for Exemption

    RJR Transportation, Inc. (RJR), USDOT 629200, is requesting an exemption to increase the 100 air-mile radius in 49 CFR 395.1(e)(1) to 150 air-miles for its drivers. This would enable the drivers not exceeding the 150 air-mile radius to utilize time records instead of a complete record of duty status (RODS) for that day.

    RJR is a local trucking operation based in Northern California operating on dedicated routes, with more than 98 percent of its trips within the 100 air-mile radius, short-haul exception. RJR primarily operates commercial motor vehicles (CMVs) with a gross vehicle weight rating (GVWR) over 55,000 pounds.

    Most of RJR's drivers qualify for and operate under the 100 air-mile radius exemption in 49 CFR 395.1(e)(1); on a weekly or monthly basis, fewer than 5 percent of its drivers may exceed the 100 air-mile radius but not a 150 air-mile radius. Specifically, RJR services three areas outside the 100 air-mile radius which are all between 100 to 140 air-miles from the normal work reporting location. RJR states that it will be forced to make a substantial investment in updating its vehicle fleet to include electronic logging devices (ELDs) for just this short extension of the 100 air-mile radius.

    Currently, RJR has five drivers who maintain paper RODS, but all of its 60 CMVs need to be equipped with ELDs in order to give the company the flexibility to put any driver in any vehicle, as it does now. Local pickup and delivery services operate under significantly different circumstances than interstate or long-haul over-the-road truck drivers. This not only presents a substantial and ongoing financial commitment in updating its fleet, but it also creates an additional regulatory requirement that will have to be managed on a daily basis.

    RJR states in its application that in order to insure an equivalent level of safety, it will continue to require its drivers to attend and participate in monthly safety meetings, including the promotion of safety through the company's Safety Incentive Program rewarding drivers for driving records free from accidents and moving violations. RJR will further continue to utilize continuous automatic event recorders, which capture among other things, speed, global positioning system location, hard braking events, and sudden turns. RJR believes that granting the exemption will achieve a level of safety equivalent to the level that would be achieved absent the proposed exemption. A copy of RJR's application for exemptions is available for review in the docket for this notice.

    Issued on: October 12, 2018. Larry W. Minor, Associate Administrator for Policy.
    [FR Doc. 2018-22702 Filed 10-17-18; 8:45 am] BILLING CODE 4910-EX-P
    83 202 Thursday, October 18, 2018 Rules and Regulations Part II Department of Transportation Pipeline and Hazardous Materials Safety Administration 49 CFR Parts 172 and 175 Hazardous Materials: Notification of the Pilot-in-Command and Response to Air Related Petitions for Rulemaking; Final Rule DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration 49 CFR Parts 172 and 175 [Docket No. PHMSA-2015-0100 (HM-259)] RIN 2137-AF10 Hazardous Materials: Notification of the Pilot-in-Command and Response to Air Related Petitions for Rulemaking AGENCY:

    Pipeline and Hazardous Materials Safety Administration (PHMSA), Department of Transportation (DOT).

    ACTION:

    Final rule.

    SUMMARY:

    PHMSA, in consultation with the Federal Aviation Administration, issues this final rule to align the U.S. Hazardous Materials Regulations with current international standards for the air transportation of hazardous materials. These amendments revise certain special provisions, packaging requirements, information to the pilot-in-command requirements, and exceptions for passengers and crewmembers. In addition to facilitating harmonization with international standards, several of the amendments in this rule are responsive to petitions for rulemaking submitted by the regulated community.

    DATES:

    Effective date: This rule is effective October 18, 2018.

    Delayed compliance date: Unless otherwise specified, compliance with the amendments adopted in this final rule is required beginning October 18, 2019.

    FOR FURTHER INFORMATION CONTACT:

    Aaron Wiener, Office of Hazardous Materials Standards, International Standards, (202) 366-4579, Pipeline and Hazardous Materials Safety Administration, U.S. Department of Transportation, 1200 New Jersey Avenue SE, 2nd Floor, Washington, DC 20590-0001.

    SUPPLEMENTARY INFORMATION: Table of Contents I. Background II. Comment Discussion A. Transportation by Air Intermediate Packaging Requirements for Certain Low and Medium Danger Hazardous Materials (P-1637) B. Quantity Limits for Portable Electronic Medical Devices Carried by Passengers, Crewmembers, and Air Operators (P-1649) C. Information to the Pilot-in-Command, Harmonization With the ICAO Technical Instructions (P-1487) D. Amendments to Package Inspection (P-1671) and Securing Requirements III. Section-by-Section Review IV. Regulatory Analyses and Notices A. Statutory/Legal Authority for This Rulemaking B. Executive Order 12866, Executive Order 13563, and DOT Regulatory Policies and Procedures C. Executive Order 13771 D. Executive Order 13132 E. Executive Order 13175 F. Regulatory Flexibility Act, Executive Order 13272, and DOT Policies and Procedures G. Paperwork Reduction Act H. Regulation Identifier Number (RIN) I. Unfunded Mandates Reform Act J. Environmental Assessment K. Privacy Act L. Executive Order 13609 and International Trade Analysis M. National Technology Transfer and Advancement Act I. Background

    On December 5, 2016, PHMSA (also “we”), in consultation with the Federal Aviation Administration (FAA), published a notice of proposed rulemaking (NPRM) [Docket No. PHMSA-2015-0100 (HM-259); 81 FR 87510] to amend the Hazardous Materials Regulations (HMR; 49 CFR parts 171-180) to align more closely with certain provisions of the International Civil Aviation Organization's Technical Instructions for the Safe Transport of Dangerous Goods by Air (ICAO Technical Instructions). These amendments update miscellaneous regulatory requirements for hazardous materials offered for transportation, or transported, in commerce by aircraft. In addition, the NPRM proposed amendments in response to four petitions for rulemaking submitted by the regulated community. The petitions are included in the docket for this proceeding and are discussed at length in Section II (Comment Discussion) of this rulemaking. In the NPRM, the phrase “notification to the pilot-in-command” and the acronym “NOTOC” were used. In this final rule, consistent with the ICAO Technical Instructions, the phrase “information to the pilot-in-command” is used.

    II. Comment Discussion

    In response to the NPRM [81 FR 87510], PHMSA received comments from the following organizations:

    • Air Line Pilots Association (ALPA) • Airlines for America (A4A) • Council on Safe Transportation of Hazardous Articles (COSTHA) • Dangerous Goods Advisory Council (DGAC) • United Parcel Service (UPS) See below for discussion of the comments received and PHMSA's determined action in this final rule. This section addresses comments made to proposals to revise the HMR based on petitions for rulemaking. Additional comments are addressed in Section III (Section-by-Section Review) of this rulemaking. A. Transportation by Air Intermediate Packaging Requirements for Certain Low and Medium Danger Hazardous Materials (P-1637)

    The DGAC petitioned PHMSA to remove the additional intermediate packaging requirements found in special provisions A3 and A6, see 49 CFR 172.102(b)(2), by deleting these special provisions and all references to them in the Hazardous Materials Table (HMT) in § 172.101. See P-1637.1 Special provisions A3 and A6 apply to certain commodities as assigned in column (7) of the HMT when transported by aircraft:

    1 See https://www.regulations.gov/docket?D=PHMSA-2014-0094.

    • Special provision A3 states that if glass inner packagings are used for transportation of referenced commodities, they must be packed with absorbent material in tightly closed metal receptacles before being packed in outer packagings.

    • Special provision A6 states that if plastic inner packagings are used for transportation of referenced commodities, they must be packed in tightly closed metal receptacles before being packed in outer packagings.

    The petitioner notes that the packaging requirements imposed by special provisions A3 and A6 are domestic provisions not found in the ICAO Technical Instructions and that maintaining these differences creates both a trade barrier to U.S. exports and a burden to the domestic market. The petitioner contends that the requirement for “metal receptacles” is overly restrictive and provides a competitive advantage to shippers in countries that allow these products to be shipped without additional intermediate packagings.

    The petitioner further notes that the following requirements in § 173.27(d) and (e) of the HMR make special provisions A3 and A6 unnecessary: (1) When transported by air, inner packagings of Packing Group (PG) I materials currently assigned A3, A6, or both are already required to be packed in either a rigid and leakproof receptacle or an intermediate packaging containing sufficient absorbent material to absorb the entire contents of the inner packaging before packing the inner packaging in its outer package; and (2) PG II and III commodities are already subject to secondary closure requirements. Therefore, the petitioner asks that the intermediate packaging requirements in special provisions A3 and A6 be removed.

    Section 173.27(d) of the HMR establishes the type of closure required for transportation of liquid hazardous materials by air. It states that the inner packaging for PG I liquid hazardous materials must have a secondary means of closure applied. The inner packaging for PG II or III liquid hazardous materials must have a secondary closure applied unless the secondary closure is impracticable. If the secondary closure is impracticable, the closure requirements for PG II and III liquids may be satisfied by securely closin