Vol. 83 Tuesday, No. 210 October 30, 2018 Pages 54513–54662

Vol. 83 Tuesday, No. 210 October 30, 2018

Pages 54513–54662

OFFICE OF THE FEDERAL REGISTER

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Contents Federal Register Vol. 83, No. 210

Tuesday, October 30, 2018

Army Department Education Department NOTICES NOTICES Agency Information Collection Activities; Proposals, Agency Information Collection Activities; Proposals, Submissions, and Approvals, 54575 Submissions, and Approvals: FY 2018 Child Care Access Means Parents in School Bureau of Safety and Environmental Enforcement Annual Performance Report Package, 54580 NOTICES Health Education Assistance Loan Program: Forms, Public Meeting, 54608 54578–54579 Income Based Repayment, 54579–54580 Centers for Medicare & Medicaid Services Student Assistance General Provisions—Subpart K—Cash PROPOSED RULES Management, 54579 Medicare Programs: International Pricing Index Model for Medicare Part B Drugs, 54546–54561 Energy Department NOTICES See Federal Energy Regulatory Commission Medicare and Medicaid Programs: NOTICES Application from the American Assn. for Accreditation of Agency Information Collection Activities; Proposals, Ambulatory Surgery Facilities, Inc. for Continued Submissions, and Approvals, 54580–54581 CMS-Approval of its Outpatient Physical Therapy Energy Conservation Program: and Speech Language Pathology Services Decision and Order Granting a Waiver to AHT Cooling Accreditation Program, 54591–54593 Systems GmbH and AHT Cooling Systems USA Inc. Performance Review Board Membership, 54591 from the Department of Energy Commercial Refrigerator, Freezer, and Refrigerator-Freezer Test Civil Rights Commission Procedure, 54581–54583 NOTICES Meetings: Meetings: Environmental Management Site-Specific Advisory New York Advisory Committee, 54566 Board, Oak Ridge, 54583–54584 Environmental Management Site-Specific Advisory Coast Guard Board, Paducah, 54584 NOTICES Agency Information Collection Activities; Proposals, Environmental Protection Agency Submissions, and Approvals, 54606–54608 RULES State Hazardous Waste Management Program: Commerce Department North Dakota, 54521–54525 See Foreign-Trade Zones Board PROPOSED RULES See Industry and Security Bureau Health and Environmental Protection Standards for See International Trade Administration Uranium and Thorium Mill Tailings, 54543–54546 See National Oceanic and Atmospheric Administration Proposed Approval of Recodification and Revisions to State Air Pollution Control Rules; North Dakota; Proposed Defense Department Interim Approval of Title V Program Recodification See Army Department and Revisions; Proposed Approval of Recodification NOTICES and Revisions to State Programs and Delegation of Arms Sales, 54575–54578 Authority to Implement and Enforce Clean Air Act Section 111 and 112 Standards and Requirements, Drug Enforcement Administration 54532–54543 NOTICES Requirements in Emission Guidelines for Municipal Solid Bulk Manufacturers of Controlled Substances; Applications: Waste Landfills, 54527–54532 Insys Manufacturing, LLC, 54611 NOTICES Sigma Aldrich Research, 54613 Agency Information Collection Activities; Proposals, Bulk Manufacturers of Controlled Substances; Registrations, Submissions, and Approvals: 54611 NESHAP for Chemical Recovery Combustion Sources at Decisions and Orders: Kraft, Soda, Sulfite, and Stand-Alone Semichemical Eric Lee Knight, M.D., 54614–54615 Pulp Mill (Renewal), 54588–54589 Importers of Controlled Substances; Applications: North Dakota Pollutant Discharge Elimination System; Cambrex High Point, Inc., 54610 Transfer, 54587–54588 Catalent CTS, LLC, 54613–54614 Fisher Clinical Services, Inc., 54612 Sharp (Bethlehem), LLC, 54612 Federal Aviation Administration United States Pharmacopeial Convention, 54611–54612 RULES Importers of Controlled Substances; Registrations, 54610– Air Traffic Service Routes: 54611 Vicinity of Mattoon and Charleston, IL, 54519

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Federal Deposit Insurance Corporation Foreign Assets Control Office NOTICES NOTICES Agency Information Collection Activities; Proposals, Blocking or Unblocking of Persons and Properties, 54652– Submissions, and Approvals, 54589–54590 54653

Federal Energy Regulatory Commission Foreign-Trade Zones Board NOTICES NOTICES Environmental Impact Statements; Availability, etc.: Subzone Status; Approvals: Venture Global Calcasieu Pass, LLC; TransCameron Digi-Key Corp., Thief River Falls, MN, 54566 Pipeline, LLC; Calcasieu Pass Project, 54586–54587 Filings: Health and Human Services Department New England Power Generators, Inc. v. ISO New England See Centers for Medicare & Medicaid Services Inc., 54584 See Food and Drug Administration Requests for Nominations: See Health Resources and Services Administration Panel Member List for Hydropower Licensing Study See National Institutes of Health Dispute Resolution, 54585–54586 Health Resources and Services Administration Requests under Blanket Authorizations: NOTICES National Fuel Gas Supply Corp., 54585 Meetings: National Advisory Council on Nurse Education and Federal Motor Carrier Safety Administration Practice, 54604 NOTICES Agency Information Collection Activities; Proposals, Homeland Security Department Submissions, and Approvals: See Coast Guard Commercial Driver Licensing and Test Standards, 54643– 54644 Industry and Security Bureau Qualification of Drivers; Exemption Applications: RULES Vision, 54644–54645 Entity List: Addition, 54519–54521 Federal Railroad Administration NOTICES Interior Department Agency Information Collection Activities; Proposals, See Bureau of Safety and Environmental Enforcement Submissions, and Approvals, 54645–54647 See Fish and Wildlife Service

Federal Reserve System Internal Revenue Service RULES PROPOSED RULES Reserve Requirements of Depository Institutions, 54517– Additional First Year Depreciation Deduction: 54519 Public Hearing, 54527 NOTICES Formations of, Acquisitions by, and Mergers of Bank International Trade Administration Holding Companies, 54590–54591 NOTICES Formations of, Acquisitions by, and Mergers of Savings and Antidumping or Countervailing Duty Investigations, Orders, Loan Holding Companies, 54591 or Reviews: Crystalline Silicon Photovoltaic Cells, Whether or Not Fish and Wildlife Service Assembled into Modules, from the People’s Republic PROPOSED RULES of China, 54566–54568 Endangered and Threatened Species: Determinations of Sales at Less than Fair Value: Removing the Hawaiian Hawk from the Federal List of Certain Steel Wheels from the People’s Republic of Endangered and Threatened Wildlife, 54561–54565 China, 54568–54570

Food and Drug Administration International Trade Commission NOTICES PROPOSED RULES Investigations; Determinations, Modifications, and Rulings, Food Additive Petitions: etc.: Adisseo France S.A.S., 54526 Certain X-Ray Breast Imaging Devices and Components Zinpro Corp., 54526 NOTICES Thereof, 54608–54610 21st Century Cures: Justice Department Announcing the Establishment of a Surrogate Endpoint See Drug Enforcement Administration Table, 54593–54594 Guidance: Labor Department Considerations for the Development of Dried Plasma See Mine Safety and Health Administration Products Intended for Transfusion, 54597–54598 See Occupational Safety and Health Administration Orders: See Workers Compensation Programs Office Denial of Hearing Request Regarding Proposal to Refuse to Approve a New Drug Application for Oxycodone Maritime Administration Hydrochloride Immediate-Release Abuse-Deterrent NOTICES Formulation, Oral Capsules, 5 Milligrams, 15 Requests for Administrative Waivers of Coastwise Trade Milligrams, and 30 Milligrams, 54598–54604 Laws: Sesame as an Allergen in Foods, 54594–54596 Vessel MACONDO, 54650–54651

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Vessel ONE LOVE, 54649–54650 Occupational Safety and Health Administration Vessel SHANGHAI MAC, 54651–54652 NOTICES Vessel Y KNOT, 54648–54649 Meetings: Vessel YEMAYA, 54647–54648 36th session of the UN Sub-Committee of Experts on the Globally Harmonized System of Classification and Mine Safety and Health Administration Labelling of Chemicals, 54616–54617 NOTICES Petitions for Modification Granted in Whole or in Part, Personnel Management Office 54615–54616 NOTICES Meetings: Federal Salary Council, 54624 National Endowment for the Arts NOTICES Meetings: Presidential Documents Arts Advisory Panel, 54618–54619 ADMINISTRATIVE ORDERS Spectrum Strategy, National; Effort to Develop Sustainability (Memorandum of October 25, 2018), National Endowment for the Humanities 54513–54516 NOTICES Meetings: Securities and Exchange Commission National Council on the Humanities, 54619–54620 NOTICES Meetings; Sunshine Act, 54630 National Foundation on the Arts and the Humanities Self-Regulatory Organizations; Proposed Rule Changes: See National Endowment for the Arts Cboe BZX Exchange, Inc., 54635–54641 See National Endowment for the Humanities Cboe EDGX Exchange, Inc., 54624–54630 Nasdaq BX, Inc., 54630–54632 Nasdaq ISE, LLC, 54632–54634 National Institutes of Health Nasdaq MRX, LLC, 54634–54635 NOTICES Nasdaq PHLX, LLC, 54641–54643 Government-Owned Inventions; Availability for Licensing, 54604–54605 Meetings: Small Business Administration Eunice Kennedy Shriver National Institute of Child NOTICES Health and Human Development, 54605 Major Disaster Declarations: National Institute of Arthritis and Musculoskeletal and Florida; Public Assistance Only, 54643 Skin Diseases, 54605–54606 National Institute on Aging, 54605 Transportation Department See Federal Aviation Administration National Oceanic and Atmospheric Administration See Federal Motor Carrier Safety Administration See Federal Railroad Administration NOTICES See Maritime Administration Agency Information Collection Activities; Proposals, Submissions, and Approvals, 54573 Meetings: Treasury Department Recommending a National Estuarine Research Reserve See Foreign Assets Control Office Site in Connecticut’s Lower Connecticut River and See Internal Revenue Service Eastern Long Island Sound, 54572–54573 NOTICES Permit Applications: Agency Information Collection Activities; Proposals, Marine Mammals; File No. 22095, 54570–54571 Submissions, and Approvals, 54660–54661 Permits: Agency Information Collection Activities; Proposals, Marine Mammals, 54571–54572 Submissions, and Approvals: Requests for Nominations: Multiple Financial Crimes Enforcement Network 2019–2022 General Advisory Committee and the Information Collection Requests, 54659–54660 Scientific Advisory Subcommittee to the United Multiple Fiscal Service Information Collection Requests, States Delegation to the Inter–American Tropical 54658–54659 Tuna Commission, 54573–54575 Multiple IRS Information Collection Requests, 54653– 54658 Nuclear Regulatory Commission Veterans Affairs Department NOTICES NOTICES Exemptions and Combined Licenses; Amendments: Annual Pay Ranges for Physicians, Dentists, and Southern Nuclear Operating Co., Inc.; Vogtle Electric Podiatrists, 54661 Generating Plant, Units 3 and 4; Changes to Tier 2 Departure Evaluation Process, 54622–54623 Instructions for Completing NRC’s Uniform Low-Level Workers Compensation Programs Office Radioactive Waste Manifest, 54620–54621 NOTICES Meetings: Agency Information Collection Activities; Proposals, Advisory Committee on Reactor Safeguards, 54623–54624 Submissions, and Approvals, 54617–54618 Meetings; Sunshine Act, 54621–54622

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Reader Aids To subscribe to the Federal Register Table of Contents Consult the Reader Aids section at the end of this issue for electronic mailing list, go to https://public.govdelivery.com/ phone numbers, online resources, finding aids, and notice accounts/USGPOOFR/subscriber/new, enter your e-mail of recently enacted public laws. address, then follow the instructions to join, leave, or manage your subscription.

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CFR PARTS AFFECTED IN THIS ISSUE

A cumulative list of the parts affected this month can be found in the Reader Aids section at the end of this issue.

3 CFR Administrative Orders: Memorandums: Memorandum of June 28, 2010 (revoked by Memo. of October 25, 2018)...... 54513 Memorandum of June 14, 2013 (revoked by Memo. of October 25, 2018)...... 54513 Memorandum of October 25, 2018 ...... 54513 12 CFR 204...... 54517 14 CFR 71...... 54519 15 CFR 744...... 54519 21 CFR Proposed Rules: 573 (2 documents) ...... 54526 26 CFR Proposed Rules: 1...... 54527 40 CFR 271...... 54521 272...... 54521 Proposed Rules: 60 (2 documents) ...... 54527, 54532 61...... 54532 63...... 54532 70...... 54532 72...... 54532 192...... 54543 42 CFR Proposed Rules: Ch. IV...... 54546 50 CFR Proposed Rules: 17...... 54561

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Federal Register Presidential Documents Vol. 83, No. 210

Tuesday, October 30, 2018

Title 3— Memorandum of October 25, 2018

The President Developing a Sustainable Spectrum Strategy for America’s Future

Memorandum for the Heads of Executive Departments and Agencies

By the authority vested in me as President by the Constitution and the laws of the United States of America, it is hereby ordered as follows: Section 1. Policy. It is the policy of the United States to use radiofrequency spectrum (spectrum) as efficiently and effectively as possible to help meet our economic, national security, science, safety, and other Federal mission goals now and in the future. To best achieve this policy, the Nation requires a balanced, forward-looking, flexible, and sustainable approach to spectrum management. The growth in the availability of mobile wireless broadband connectivity over the past decade has reshaped the American experience—the way Ameri- cans work, learn, shop, run businesses, transport their families and goods across the Nation, farm, conduct financial transactions, consume entertain- ment, deliver and receive public safety services, and interact with one another. In the growing digital economy, wireless technologies expand opportunities to increase economic output of rural communities and connect them with urban markets, and offer safety benefits that save lives, prevent injuries, and reduce the cost of transportation incidents. American companies and institutions rely heavily on high-speed wireless connections, with increasing demands on both speed and capacity. Wireless technologies are helping to bring broadband to rural, unserved, and underserved parts of America. Spectrum-dependent systems also are indispensable to the performance of many important United States Government missions. And as a Nation, our dependence on these airwaves is likely to continue to grow. As the National Security Strategy of 2017 made clear, access to spectrum is a critical component of the technological capabilities that enable economic activity and protect national security. Wireless communications and associated data applications establish a foundation for high-wage jobs and national prosperity. While American industry continues to extract greater and greater value from spectrum, each technological leap also increases demands on its usage. Those demands have never been greater than today, with the advent of autonomous vehicles and precision agriculture, the expansion of commercial space operations, and the burgeoning Internet of Things signaling a nearly insatiable demand for spectrum access. Moreover, it is impera- tive that America be first in fifth-generation (5G) wireless technologies— wireless technologies capable of meeting the high-capacity, low-latency, and high-speed requirements that can unleash innovation broadly across diverse sectors of the economy and the public sector. Flexible, predictable spectrum access by the United States Government will help ensure that Federal users can meet current and future mission requirements for a broad range of both communications- and non-communications-based systems. The Nation can and will ensure security and safety through modern technology. America’s national security depends on technological excellence and the United States Government must continue to have access to the spectrum resources needed to serve the national interest, from protecting the homeland and managing the national airspace, to forecasting severe weather and exploring the frontiers of space. Technological innovation in

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spectrum usage, moreover, occurs in both the private and public sectors. Federal agencies must thoughtfully consider whether and how their spectrum-dependent mission needs might be met more efficiently and effectively, including through new technology and ingenuity. The United States Govern- ment shall continue to look for additional opportunities to share spectrum among Federal and non-Federal entities. The United States Government shall also continue to encourage investment and adoption by Federal agencies of commercial, dual-use, or other advanced technologies that meet mission requirements, including 5G technologies. In doing so, we will take appropriate measures to sustain the radiofrequency environment in which critical United States infrastructure and space systems operate. Sec. 2. Advancing the National Spectrum Strategy. Within 180 days of the date of this memorandum, and concurrent with development of the National Spectrum Strategy referred to in section 4 of this memorandum: (a) Executive departments and agencies (agencies) shall report to the Sec- retary of Commerce (Secretary), working through the National Telecommuni- cations and Information Administration (NTIA), on their anticipated future spectrum requirements for a time period and in a format specified by the Secretary. Additionally, agencies shall initiate a review of their current frequency assignments and quantification of their spectrum usage in accordance with guidance to be provided by the Secretary. Reporting of information under this section shall be subject to existing safeguards protecting classified, sensitive, and proprietary data. The Secretary may release publicly a summary of information provided by agencies, to the extent consistent with applicable law. (b) The Director of the Office of Science and Technology Policy (OSTP), or the Director’s designee, shall submit a report to the President on emerging technologies and their expected impact on non-Federal spectrum demand. (c) The Director of OSTP, or the Director’s designee, shall submit a report to the President on recommendations for research and development priorities that advance spectrum access and efficiency. Sec. 3. Within 180 days of the date of this memorandum, and annually thereafter, the Secretary, working through the NTIA, and in coordination with the Office of Management and Budget (OMB), OSTP, and the Federal Communications Commission (FCC), shall submit to the President, through the Director of the National Economic Council and the Assistant to the President for National Security Affairs, a report (to be made public to the extent practicable and consistent with applicable law) on the status of existing efforts and planned near- to mid-term spectrum repurposing initiatives. Sec. 4. Within 270 days of the date of this memorandum, the Secretary, working through the NTIA, and in consultation with OMB, OSTP, and the FCC, and other Federal entities, as appropriate, shall submit to the President, through the Director of the National Economic Council and the Assistant to the President for National Security Affairs, a long-term National Spectrum Strategy that includes legislative, regulatory, or other policy recommendations to: (a) increase spectrum access for all users, including on a shared basis, through transparency of spectrum use and improved cooperation and collaboration between Federal and non-Federal spectrum stakeholders; (b) create flexible models for spectrum management, including standards, incentives, and enforcement mechanisms that promote efficient and effective spectrum use, including flexible-use spectrum licenses, while accounting for critical safety and security concerns; (c) use ongoing research, development, testing, and evaluation to develop advanced technologies, innovative spectrum-utilization methods, and spectrum-sharing tools and techniques that increase spectrum access, efficiency, and effectiveness;

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(d) build a secure, automated capability to facilitate assessments of spectrum use and expedite coordination of shared access among Federal and non-Federal spectrum stakeholders; and (e) improve the global competitiveness of United States terrestrial and space-related industries and augment the mission capabilities of Federal entities through spectrum policies, domestic regulations, and leadership in international forums. Sec. 5. Spectrum Strategy Task Force. The Chief Technology Officer and the Director of the National Economic Council, or their designees, shall co-chair a Spectrum Strategy Task Force that shall include representatives from OMB, OSTP, the National Security Council, the National Space Council, and the Council of Economic Advisers. The Spectrum Strategy Task Force shall work with the Secretary and the NTIA in coordinating implementation of this memorandum. In carrying out its coordination functions, the Spectrum Strategy Task Force shall consult with the FCC. Sec. 6. 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 OMB relating to budgetary, administrative, or legislative proposals. (b) Nothing in this memorandum shall be construed to require the disclosure of classified information, law enforcement sensitive information, proprietary information, or other information that must be protected as required by law or in the interests of national security or public safety. (c) This memorandum shall be implemented consistent with applicable law and subject to the availability of appropriations. (d) 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. (e) The Presidential Memoranda of June 28, 2010 (Unleashing the Wireless Broadband Revolution) and June 14, 2013 (Expanding America’s Leadership in Wireless Innovation) are hereby revoked.

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(f) The Secretary is authorized and directed to publish this memorandum in the Federal Register.

THE WHITE HOUSE, Washington, October 25, 2018

[FR Doc. 2018–23839 Filed 10–29–18; 8:45 am] Billing code 3510–07–P

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Rules and Regulations Federal Register Vol. 83, No. 210

Tuesday, October 30, 2018

This section of the FEDERAL REGISTER period that begins January 17, 2019. For December 31 of each year, the Board contains regulatory documents having general depository institutions that report shall issue a regulation adjusting the applicability and legal effect, most of which deposit data weekly, this maintenance reserve requirement exemption amount are keyed to and codified in the Code of period corresponds to the fourteen-day for the next calendar year if total Federal Regulations, which is published under computation period that begins reservable liabilities held at all 50 titles pursuant to 44 U.S.C. 1510. December 18, 2018. For depository depository institutions increase from The Code of Federal Regulations is sold by institutions that report deposit data one year to the next. No adjustment is the Superintendent of Documents. quarterly, this maintenance period made to the reserve requirement corresponds to the seven-day exemption amount if total reservable computation period that begins liabilities held at all depository FEDERAL RESERVE SYSTEM December 18, 2018. The new values of institutions should decrease during the the nonexempt deposit cutoff level, the applicable time period. The Act requires 12 CFR Part 204 reserve requirement exemption amount, the percentage increase in the reserve [Regulation D; Docket No. R–1626] and the reduced reporting limit will be requirement exemption amount to be 80 used to determine the frequency at percent of the increase in total RIN 7100–AF19 which a depository institution submits reservable liabilities of all depository Reserve Requirements of Depository deposit reports effective in either June institutions over the one-year period Institutions or September 2019. that ends on the June 30 prior to the FOR FURTHER INFORMATION CONTACT: adjustment. AGENCY: Board of Governors of the Sophia H. Allison, Senior Special Total reservable liabilities of all Federal Reserve System. Counsel (202/452–3565), Legal Division, depository institutions increased by 2.4 ACTION: Final rule. or Kristen R. Payne, Senior Financial percent, from $7,858 billion to $8,050 Institution and Policy Analyst (202/ billion, between June 30, 2017, and June SUMMARY: The Board is amending 452–2872), Division of Monetary 30, 2018. Accordingly, the Board is Regulation D, Reserve Requirements of Affairs; for users of amending Regulation D to set the Depository Institutions, to reflect the Telecommunications Device for the Deaf reserve requirement exemption amount annual indexing of the reserve (TDD) only, contact (202/263–4869); for 2019 at $16.3 million, an increase of requirement exemption amount and the Board of Governors of the Federal $0.3 million from its level in 2018.1 low reserve tranche for 2019. The Reserve System, 20th and C Streets NW, Pursuant to section 19(b)(2) of the Act Regulation D amendments set the Washington, DC 20551. (12 U.S.C. 461(b)(2)), transaction amount of total reservable liabilities of SUPPLEMENTARY INFORMATION: Section account balances maintained at each each depository institution that is 19(b)(2) of the Federal Reserve Act (12 depository institution over the reserve subject to a zero percent reserve U.S.C. 461(b)(2)) requires each requirement exemption amount and up requirement in 2019 at $16.3 million depository institution to maintain to a certain amount, known as the low (up from 16.0 million in 2018). This reserves against its transaction accounts reserve tranche, are subject to a three amount is known as the reserve and nonpersonal time deposits, as percent reserve requirement. requirement exemption amount. The prescribed by Board regulations, for the Transaction account balances over the Regulation D amendments also set the purpose of implementing monetary low reserve tranche are subject to a ten amount of net transaction accounts at policy. Section 11(a)(2) of the Federal percent reserve requirement. Section each depository institution (over the Reserve Act (12 U.S.C. 248(a)(2)) 19(b)(2) also provides that, before reserve requirement exemption amount) authorizes the Board to require reports December 31 of each year, the Board that is subject to a three percent reserve of liabilities and assets from depository shall issue a regulation adjusting the requirement in 2019 at $124.2 million institutions to enable the Board to low reserve tranche for the next (up from $122.3 million in 2018). This conduct monetary policy. The Board’s calendar year. The Act requires the amount is known as the low reserve actions with respect to each of these adjustment in the low reserve tranche to tranche. The adjustments to both of provisions are discussed in turn below. be 80 percent of the percentage increase these amounts are derived using or decrease in total transaction accounts statutory formulas specified in the I. Reserve Requirements of all depository institutions over the Federal Reserve Act. Pursuant to section 19(b) of the one-year period that ends on the June 30 The Board is also announcing changes Federal Reserve Act (Act), transaction prior to the adjustment. in two other amounts, the nonexempt account balances maintained at each Net transaction accounts of all deposit cutoff level and the reduced depository institution are subject to depository institutions increased 2.0 reporting limit, that are used to reserve requirement ratios of zero, three, percent, from $2,379 billion to $2,425 determine the frequency at which or ten percent. Section 19(b)(11)(A) of billion, between June 30, 2017, and June depository institutions must submit the Act (12 U.S.C. 461(b)(11)(A)) 30, 2018. Accordingly, the Board is deposit reports. provides that a zero percent reserve amending Regulation D to set the low DATES: requirement shall apply at each reserve tranche for net transaction Effective date: November 29, 2018. depository institution to total reservable Compliance dates: The new low liabilities that do not exceed a certain 1 Consistent with Board practice, the low reserve reserve tranche and reserve requirement amount, known as the reserve tranche and reserve requirement exemption exemption amount will apply to the requirement exemption amount. Section amounts have been rounded to the nearest $0.1 fourteen-day reserve maintenance 19(b)(11)(B) provides that, before million.

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accounts for 2019 at $124.2 million, an to 80 percent of the increase, if any, in reported values on its FR 2910a report increase of $1.9 million from 2018. total transaction accounts, savings in order to qualify for reduced reporting The new low reserve tranche and deposits, and small time deposits of all will be shifted to an FR 2900 reporting reserve requirement exemption amount depository institutions over the one-year panel. will be effective for all depository period that ends on the June 30 prior to III. Regulatory Analysis institutions for the fourteen-day reserve the adjustment. maintenance period beginning From June 30, 2017, to June 30, 2018, Administrative Procedure Act Thursday, January 17, 2019. For total transaction accounts, savings depository institutions that report deposits, and small time deposits at all The provisions of 5 U.S.C. 553(b) deposit data weekly, this maintenance depository institutions increased 3.6 relating to notice of proposed period corresponds to the fourteen-day percent, from $12,157 billion to $12,599 rulemaking have not been followed in computation period that begins billion. Accordingly, the Board is connection with the adoption of these December 18, 2018. For depository increasing the nonexempt deposit cutoff amendments. The amendments involve institutions that report deposit data level by $29.1 million to $1.029 billion expected, ministerial adjustments quarterly, this maintenance period for 2019 (up from $1.000 billion in prescribed by statute and by the Board’s corresponds to the seven-day 2018). The Board is also increasing the policy concerning reporting practices. computation period that begins reduced reporting limit by $60.7 million The adjustments in the reserve December 18, 2018. to $2.147 billion for 2019 (up from requirement exemption amount, the low 2 reserve tranche, the nonexempt deposit II. Deposit Reports $2.086 billion in 2018). Beginning in 2019, the boundaries of cutoff level, and the reduced reporting Section 11(b)(2) of the Federal the four deposit reporting panels will be limit serve to reduce regulatory burdens Reserve Act authorizes the Board to defined as follows. Those depository on depository institutions. Accordingly, require depository institutions to file institutions with net transaction the Board finds good cause for reports of their liabilities and assets as accounts over $16.3 million (the reserve determining, and so determines, that the Board may determine to be requirement exemption amount) or with notice in accordance with 5 U.S.C. necessary or desirable to enable it to total transaction accounts, savings 553(b) is unnecessary. discharge its responsibility to monitor deposits, and small time deposits Regulatory Flexibility Act and control the monetary and credit greater than or equal to $2.147 billion aggregates. The Board screens (the reduced reporting limit) are subject The Regulatory Flexibility Act (RFA) depository institutions each year and to detailed reporting, and must file a does not apply to a rulemaking where a assigns them to one of four deposit Report of Transaction Accounts, Other general notice of proposed rulemaking 3 reporting panels (weekly reporters, Deposits and Vault Cash (FR 2900 is not required. As noted previously, quarterly reporters, annual reporters, or report) either weekly or quarterly. Of the Board has determined that it is nonreporters). The panel assignment for this group, those with total transaction unnecessary to publish a general notice annual reporters is effective in June of accounts, savings deposits, and small of proposed rulemaking for this final the screening year; the panel assignment time deposits greater than or equal to rule. Accordingly, the RFA’s for weekly and quarterly reporters is $1.029 billion (the nonexempt deposit requirements relating to an initial and effective in September of the screening cutoff level) are required to file the FR final regulatory flexibility analysis do year. 2900 report each week, while those with not apply. In order to ease reporting burden, the Board permits smaller depository total transaction accounts, savings Paperwork Reduction Act institutions to submit deposit reports deposits, and small time deposits less than $1.029 billion are required to file In accordance with the Paperwork less frequently than larger depository Reduction Act of 1995,4 the Board institutions. The Board permits the FR 2900 report each quarter. Those depository institutions with net reviewed this final rule. No collections depository institutions with net of information pursuant to the transaction accounts above the reserve transaction accounts less than or equal to $16.3 million (the reserve Paperwork Reduction Act are contained requirement exemption amount but total in the final rule. transaction accounts, savings deposits, requirement exemption amount) and and small time deposits below a with total transaction accounts, savings List of Subjects in 12 CFR Part 204 specified level (the ‘‘nonexempt deposit deposits, and small time deposits less than $2.147 billion (the reduced Banks, banking, Reporting and cutoff’’) to report deposit data quarterly. recordkeeping requirements. Depository institutions with net reporting limit) are eligible for reduced transaction accounts above the reserve reporting, and must either file a deposit For the reasons set forth in the requirement exemption amount and report annually or not at all. Of this preamble, the Board is amending 12 with total transaction accounts, savings group, those with total deposits greater CFR part 204 as follows: than $16.3 million (but with total deposits, and small time deposits PART 204—RESERVE greater than or equal to the nonexempt transaction accounts, savings deposits, and small time deposits less than $2.147 REQUIREMENTS OF DEPOSITORY deposit cutoff are required to report INSTITUTIONS (REGULATION D) deposit data weekly. The Board requires billion) are required to file the Annual Report of Deposits and Reservable certain large depository institutions to ■ Liabilities (FR 2910a) report annually, 1. The authority citation for part 204 report weekly regardless of the level of continues to read as follows: their net transaction accounts if the while those with total deposits less than depository institution’s total transaction or equal to $16.3 million are not Authority: 12 U.S.C. 248(a), 248(c), 461, 601, 611, and 3105. accounts, savings deposits, and small required to file a deposit report. A time deposits exceeds or is equal to a depository institution that adjusts ■ 2. Section 204.4 is amended by specified level (the ‘‘reduced reporting revising paragraph (f) to read as follows: 2 Consistent with Board practice, the nonexempt limit’’). The nonexempt deposit cutoff deposit cutoff level has been rounded to the nearest level and the reduced reporting limit are $0.1 million, and the reduced reporting limit has 3 5 U.S.C. 603 and 604. adjusted annually, by an amount equal been rounded to the nearest $1 million. 4 44 U.S.C. 3506; 5 CFR part 1320.

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§ 204.4 Computation of required reserves. United States branches and agencies of transaction accounts, nonpersonal time * * * * * foreign banks, required reserves are deposits, and Eurocurrency liabilities of (f) For all depository institutions, computed by applying the reserve the institution during the computation Edge and Agreement corporations, and requirement ratios below to net period.

Reservable liability Reserve requirement

Net Transaction Accounts: $0 to reserve requirement exemption amount ($16.3 million) ...... 0 percent of amount. Over reserve requirement exemption amount ($16.3 million) and 3 percent of amount. up to low reserve tranche ($124.2 million). Over low reserve tranche ($124.2 million) ...... $3,237,000 plus 10 percent of amount over $124.2 million. Nonpersonal time deposits ...... 0 percent. Eurocurrency liabilities ...... 0 percent.

By order of the Board of Governors of the Office of Airspace Services, Federal Delay of Effective Date Federal Reserve System, acting through the Aviation Administration, 800 ■ Accordingly, pursuant to the authority Director of the Division of Monetary Affairs Independence Avenue SW, Washington, under delegated authority, October 24, 2018. delegated to me, the effective date of the DC 20591; telephone: (202) 267–8783. Ann E. Misback, final rule, Airspace Docket 17–AGL–23, Secretary of the Board. SUPPLEMENTARY INFORMATION: as published in the Federal Register on September 7, 2018 (83 FR 45337), FR [FR Doc. 2018–23608 Filed 10–29–18; 8:45 am] Background BILLING CODE 6210–01–P Doc. 2018–19347, is hereby delayed The FAA published a final rule in the from November 8, 2018 to January 3, Federal Register for Docket No. FAA– 2019. DEPARTMENT OF TRANSPORTATION 2018–0219 (83 FR 45337, September 7, Authority: 49 U.S.C. 106(f), 106(g); 40103, 2018), amending VOR Federal airways 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, Federal Aviation Administration V–72 and V–429 in the vicinity of 1959–1963 Comp., P. 389. Mattoon and Charleston, IL. The Issued in Washington, DC, on October 24, 14 CFR Part 71 effective date for that final rule is 2018. [Docket No. FAA–2018–0219; Airspace November 8, 2018. The FAA expects to Rodger A. Dean Jr., Docket No. 17–AGL–23] complete and flight check the enroute Manager, Airspace Policy Group. RIN 2120–AA66 and terminal procedures associated with [FR Doc. 2018–23563 Filed 10–29–18; 8:45 am] the planned decommissioning of the BILLING CODE 4910–13–P Amendment of Air Traffic Service Mattoon, IL, VOR by January 3, 2018; (ATS) Routes in the Vicinity of Mattoon therefore the rule amending V–72 and and Charleston, IL V–429 is delayed to coincide with that DEPARTMENT OF COMMERCE date. AGENCY: Federal Aviation Bureau of Industry and Security Administration (FAA), DOT. VOR Federal airways are published in ACTION: Final rule, delay of effective paragraph 6010(a) of FAA Order 15 CFR Part 744 date. 7400.11C dated August 13, 2018, and effective September 15, 2018, which is [Docket No. 181010930–8930–01] SUMMARY: This action changes the incorporated by reference in 14 CFR RIN 0694–AH67 effective date of a final rule published 71.1. The VOR Federal airways listed in in the Federal Register on September 7, this document will be subsequently Addition of an Entity to the Entity List 2018, amending VHF Omnidirectional published in the Order. Range (VOR) Federal airways V–72 and AGENCY: Bureau of Industry and V–429 in the vicinity of Mattoon and Good Cause for No Notice and Security, Commerce. Charleston, IL. The FAA is delaying the Comment ACTION: Final rule. effective date to coincide with the expected completion and flight check of Section 553(b)(3)(B) of Title 5, United SUMMARY: In this rule, the Bureau of enroute and terminal procedures States Code, (the Administrative Industry and Security (BIS) amends the associated with the planned Procedure Act) authorizes agencies to Export Administration Regulations decommissioning of the Mattoon, IL, dispense with notice and comment (EAR) by adding one entity to the Entity VOR. procedures for rules when the agency List. The entity that is added to the DATES: The effective date of the final for ‘‘good cause’’ finds that those Entity List has been determined by the rule published on September 7, 2018 (83 procedures are ‘‘impracticable, U.S. Government to pose a significant FR 45337) is delayed from November 8, unnecessary, or contrary to the public risk of becoming involved in activities 2018 to January 3, 2019. The Director of interest.’’ Under this section, an agency, contrary to the national security or the Federal Register approved this upon finding good cause, may issue a foreign policy interests of the United incorporation by reference action under final rule without seeking comment States. This entity will be listed under Title 1 Code of Federal Regulations part prior to the rulemaking. The FAA finds the destination of China. 51, subject to the annual revision of that prior notice and public comment to DATES: Effective Date: This rule is FAA Order 7400.11 and publication of this final rule is unnecessary due to the effective October 30, 2018. conforming amendments. brief length of the extension of the FOR FURTHER INFORMATION CONTACT: FOR FURTHER INFORMATION CONTACT: effective date and the fact that there is Chair, End-User Review Committee, Colby Abbott, Airspace Policy Group, no substantive change to the rule.’’ Office of the Assistant Secretary, Export

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Administration, Bureau of Industry and entity raises sufficient concern that pursuant to the International Emergency Security, Department of Commerce, prior review of exports, reexports, or Economic Powers Act (50 U.S.C. 1701 et Phone: (202) 482–5991, Fax: (202) 482– transfers (in-country) of items subject to seq.) and Executive Order 13222 of 3911, Email: [email protected]. the EAR involving this entity, and the August 17, 2001, 3 CFR, 2001 Comp., p. SUPPLEMENTARY INFORMATION: possible imposition of license 783 (2002), as amended by Executive conditions or license denials on Order 13637 of March 8, 2013, 78 FR Background shipments to the entity, will enhance 16129 (March 13, 2013), and as The Entity List (15 CFR, Subchapter BIS’s ability to prevent activities extended by the Notice of August 8, C, part 744, Supplement No. 4) contrary to the national security 2018, 83 FR 39871 (August 13, 2018)), identifies entities reasonably believed to interests of the United States. or the Export Administration be involved, or to pose a significant risk For the one entity added to the Entity Regulations, and are in effect as of of being or becoming involved, in List in this final rule, BIS imposes a August 13, 2018, shall continue in effect activities contrary to the national license requirement for all items subject according to their terms until modified, security or foreign policy interests of the to the EAR and a license review policy superseded, set aside, or revoked under United States. The Export of presumption of denial. In addition, the authority of ECRA. Administration Regulations (EAR) (15 no license exceptions are available for Rulemaking Requirements CFR, Subchapter C, parts 730–774) exports, reexports, or transfers (in- imposes additional license requirements country) to the person being added to 1. Executive Orders 13563 and 12866 on, and limits the availability of most the Entity List in this rule. The acronym direct agencies to assess all costs and license exceptions for, exports, ‘‘a.k.a.’’ (also known as) is used in benefits of available regulatory reexports, and transfers (in-country) to entries on the Entity List to identify alternatives and, if regulation is listed entities. The license review policy aliases, thereby assisting exporters, necessary, to select regulatory for each listed entity is identified in the reexporters and transferors in approaches that maximize net benefits ‘‘License review policy’’ column on the identifying entities on the Entity List. (including potential economic, Entity List, and the impact on the This final rule adds the following environmental, public health and safety availability of license exceptions is entity to the Entity List: effects, distributive impacts, and described in the relevant Federal China equity). Executive Order 13563 Register notice adding entities to the emphasizes the importance of Entity List. BIS places entities on the (1) Fujian Jinhua Integrated Circuit quantifying both costs and benefits, of Entity List pursuant to part 744 (Control Company, Ltd., a.k.a., the following one reducing costs, of harmonizing rules, Policy: End-User and End-Use Based) alias: -JHICC. and of promoting flexibility. This rule and part 746 (Embargoes and Other Sanchuang Park, Century Avenue, has been determined to be not Special Controls) of the EAR. Jinjiang City, Fujian Province, China. significant for purposes of Executive The End-User Review Committee Savings Clause Order 12866. This rule is not an (ERC), composed of representatives of Shipments of items removed from Executive Order 13771 regulatory action the Departments of Commerce (Chair), eligibility for a License Exception or because this rule is not significant under State, Defense, Energy and, where export or reexport without a license Executive Order 12866. appropriate, the Treasury, makes all (NLR) as a result of this regulatory 2. Notwithstanding any other decisions regarding additions to, action that were en route aboard a provision of law, no person is required removals from, or other modifications to carrier to a port of export or reexport, on to respond to nor be subject to a penalty the Entity List. The ERC makes all October 30, 2018, pursuant to actual for failure to comply with a collection decisions to add an entry to the Entity orders for export or reexport to a foreign of information subject to the List by majority vote and all decisions destination, may proceed to that requirements of the Paperwork to remove or modify an entry by destination under the previous Reduction Act of 1995 (44 U.S.C. 3501 unanimous vote. eligibility for a License Exception or et seq.) (PRA), unless that collection of ERC Entity List Decision export or reexport without a license information displays a currently valid (NLR). Office of Management and Budget Addition to the Entity List (OMB) Control Number. This regulation Under § 744.11(b) (Criteria for Export Control Reform Act of 2018 involves collections previously revising the Entity List) of the EAR, On August 13, 2018, the President approved by OMB under control persons for whom there is reasonable signed into law the John S. McCain number 0694–0088, Simplified Network cause to believe, based on specific and National Defense Authorization Act for Application Processing System, which articulable facts, have been involved, Fiscal Year 2019, which included the includes, among other things, license are involved, or pose a significant risk Export Control Reform Act of 2018 applications, and carries a burden of being or becoming involved in, (ECRA) (Title XVII, Subtitle B of Pub. L. estimate of 43.8 minutes for a manual or activities that are contrary to the 115–232), which provides the legal basis electronic submission. national security or foreign policy for BIS’s principal authorities and Total burden hours associated with interests of the United States, and those serves as the authority under which BIS the PRA and OMB control number acting on behalf of such persons, may be issues this rule. As set forth in section 0694–0088 are not expected to increase added to the Entity List. 1768 of ECRA, all delegations, rules, as a result of this rule. You may send Pursuant to 744.11(b) of the EAR, the regulations, orders, determinations, comments regarding the collection of ERC determined that Fujian Jinhua licenses, or other forms of information associated with this rule, Integrated Circuit Company poses a administrative action that have been including suggestions for reducing the significant risk of becoming involved in made, issued, conducted, or allowed to burden, to Jasmeet K. Seehra, Office of activities that could have a negative become effective under the Export Management and Budget (OMB), by impact on the national security interests Administration Act of 1979 (50 U.S.C. email to Jasmeet_K._Seehra@ of the United States. The ERC 4601 et seq.) (as in effect prior to August omb.eop.gov, or by fax to (202) 395– determined that the conduct of this 13, 2018, and as continued in effect 7285.

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3. This rule does not contain policies 601, et seq., are not applicable. CFR, 1994 Comp., p. 950; E.O. 12947, 60 FR with Federalism implications as that Accordingly, no regulatory flexibility 5079, 3 CFR, 1995 Comp., p. 356; E.O. 13026, term is defined in Executive Order analysis is required and none has been 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13132. prepared. 13099, 63 FR 45167, 3 CFR, 1998 Comp., p. 208; E.O. 13222, 66 FR 44025, 3 CFR, 2001 4. Pursuant to section 1762 of the List of Subjects in 15 CFR Part 744 Comp., p. 783; E.O. 13224, 66 FR 49079, 3 Export Control Reform Act of 2018 CFR, 2001 Comp., p. 786; Notice of (Title XVII, Subtitle B of Pub. L. 115– Exports, Reporting and recordkeeping September 18, 2017, 82 FR 43825 (September 232), which was included in the John S. requirements, Terrorism. 19, 2017); Notice of November 6, 2017, 82 FR McCain National Defense Authorization Accordingly, part 744 of the Export 51971 (November 8, 2017); Notice of January Act for Fiscal Year 2019, this action is Administration Regulations (15 CFR 17, 2018, 83 FR 2731 (January 18, 2018); exempt from the Administrative parts 730–774) is amended as follows: Notice of August 8, 2018, 83 FR 39871 Procedure Act (APA) (5 U.S.C. 553) (August 13, 2018). PART 744—[AMENDED] requirements for notice of proposed ■ 2. Supplement No. 4 to part 744 is rulemaking, opportunity for public ■ 1. The authority citation for 15 CFR amended by adding in alphabetical participation, and delay in effective part 744 continues to read as follows: order, under CHINA, PEOPLE’S date. REPUBLIC OF, one Chinese entity, 5. Because a notice of proposed Authority: Pub. L. 115–232, Title XVII, Subtitle B. 50 U.S.C. 4601 et seq.; 50 U.S.C. ‘‘Fujian Jinhua Integrated Circuit rulemaking and an opportunity for 1701 et seq.; 22 U.S.C. 3201 et seq.; 42 U.S.C. Company, Ltd.’’ to read as follows: public comment are not required to be 2139a; 22 U.S.C. 7201 et seq.; 22 U.S.C. 7210; given for this rule by the APA or any Supplement No. 4 to Part 744—Entity E.O. 12058, 43 FR 20947, 3 CFR, 1978 Comp., List other law, the analytical requirements of p. 179; E.O. 12851, 58 FR 33181, 3 CFR, 1993 the Regulatory Flexibility Act, 5 U.S.C. Comp., p. 608; E.O. 12938, 59 FR 59099, 3 * * * * *

Federal Country Entity License License Register requirement review policy citation

*******

CHINA, PEOPLE’S REPUBLIC OF ..... ****** Fujian Jinhua Integrated Circuit Com- For all items sub- Presumption of de- 83 FR [INSERT pany, Ltd., a.k.a., the following one ject to the EAR. nial. FR PAGE NUM- alias: -JHICC. (See § 744.11 of BER] 10/30/ the EAR). 2018. Sanchuang Park, Century Avenue, Jinjiang City, Fujian Province, China. ******

*******

Dated: October 25, 2018. SUMMARY: The Environmental Protection No. EPA–R08–RCRA–2018–0084. All Richard E. Ashooh, Agency (EPA) is granting final documents in the docket are listed on Assistant Secretary for Export authorization to the hazardous waste the http://www.regulations.gov website. Administration. program revisions submitted by North Although listed in the index, some [FR Doc. 2018–23693 Filed 10–29–18; 8:45 am] Dakota on September 20, 2016 and information is not publicly available, BILLING CODE 3510–33–P March 24, 2017. The EPA published a e.g., Confidential Business Information proposed rule on June 5, 2018, and (CBI) or other information whose provided for public comment. The disclosure is restricted by statute. comment period ended on July 5, 2018. Certain other material, such as ENVIRONMENTAL PROTECTION No comments were received for this copyrighted material, is not placed on AGENCY rulemaking. No further opportunity for the internet and will be publicly comment will be provided. This final available only in hard copy form. 40 CFR Parts 271 and 272 rule also codifies and incorporates by Publicly available docket materials are reference the authorized provisions of available either electronically through [EPA–R08–RCRA–2018–0084; FRL–9982– the North Dakota regulations in the 08–Region 8] Code of Federal Regulations. http://www.regulations.gov or in hard copy at: EPA Region 8, from 8:00 a.m. North Dakota: Authorization of State DATES: This final rule is effective on to 4:00 p.m., 1595 Wynkoop Street, Hazardous Waste Management October 30, 2018. The incorporation by Denver, Colorado 80202–1129, contact: Program Revisions and Incorporation reference of authorized provisions in the Moye Lin, phone number (303) 312– by Reference of Approved State North Dakota regulations contained in 6667, or the North Dakota Department of Hazardous Waste Management this rule is approved by the Director of Health (NDDH) from 9:00 a.m. to 4:00 Program the Federal Register as of October 30, p.m., 918 East Divide Avenue, 3rd 2018, in accordance with 5 U.S.C. 552(a) Floor, Bismarck, North Dakota 58501– AGENCY: Environmental Protection and 1 CFR part 51. Agency (EPA). 1947, phone number (701) 328–5166. ADDRESSES: The EPA has established a The public is advised to call in advance ACTION: Final rule. docket for this action under Docket ID to verify business hours.

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FOR FURTHER INFORMATION CONTACT: ADDRESSES section of this preamble for authorized program being incorporated Moye Lin, Resource Conservation and more information). Copies of the by reference. While ‘‘broader in scope’’ Recovery Program, EPA Region 8, 1595 regulations that are incorporated by provisions are not part of the authorized Wynkoop Street, Denver, Colorado reference are also available from the program and cannot be enforced by the 80202–1129; phone number (303) 312– North Dakota Department of Health EPA, the state may enforce such 6667; Email address: [email protected]. (NDDH) from 9:00 a.m. to 4:00 p.m., 918 provisions under state law. SUPPLEMENTARY INFORMATION: East Divide Avenue, 3rd Floor, North Dakota has adopted, but is not Bismarck, North Dakota 58501–1947, authorized for, the federal rules I. Authorization of Revisions to North phone number (701) 328–5166. The published in the Federal Register on Dakota’s Hazardous Waste Program public is advised to call in advance to April 12, 1996 (61 FR 16290); October and Clarification verify business hours. 22, 1998 (63 FR 56710), and January 8, North Dakota submitted a final Section 272.1751 also references 2010 (75 FR 1235). Therefore, these complete program revision application material which is not being federal amendments included in North on September 20, 2016, and March 24, incorporated by reference, but which Dakota’s adoption by reference at 2017, seeking authorization of their the EPA considered in determining the section 33–24–06–16.5 of the North changes in accordance with 40 CFR adequacy of North Dakota’s program. Dakota Administrative Code, are not 271.21. We now make a final decision Section 272.1751(c)(2) references the part of the state’s authorized program that North Dakota’s hazardous waste demonstration of adequate authority, and are not part of the incorporation by program revisions satisfy all of the including procedural and enforcement reference. The June 5, 2018 proposed requirements necessary to qualify for provisions, which provides the legal rule provides details about state final authorization. For a list of rules basis for the state’s implementation of provisions which are not part of this that become effective with this final the hazardous waste management amendment to the CFR, as well as the rule, please see the proposed rule program. In addition, § 272.1751(c)(5), effect of North Dakota’s codification on published in the June 5, 2018 Federal (c)(6), and (c)(7) reference the enforcement and on federal Register at 83 FR 25986. The EPA is Memorandum of Agreement, the requirements promulgated under the making one clarification to the proposed Attorney General’s Statements, and the Hazardous and Solid Waste rule with respect to the impact of the Program Description, respectively. Amendments of 1984 (HSWA). vacatur of certain provisions of the These documents are evaluated as part III. Administrative Requirements Revisions to the Definition of Solid of the approval process of the hazardous Waste (DSW) Rule published on January waste management program in The Office of Management and Budget 13, 2015 (80 FR 1694), by the U.S. Court accordance with subtitle C of RCRA but (OMB) has exempted this action from of Appeals for the District of Columbia are not part of the material to be the requirements of Executive Orders Circuit, Am. Petroleum Inst. v. EPA, 862 incorporated by reference. The public is 12866 (58 FR 51735, October 4, 1993) F.3d 50 (D.C. Cir. 2017) and Am. reminded that some provisions of North and 13563 (76 FR 3821, January 21, Petroleum Inst. v. EPA, No. 09–1038 Dakota’s hazardous waste program are 2011). This action authorizes and (D.C. Cir. Mar. 6, 2018). On May 30, not part of the federally-authorized state codifies state requirements for the 2018 (83 FR 24664; Response to Vacatur program. These non-authorized purpose of RCRA section 3006 and of Certain Provisions of the Definition of provisions include: imposes no additional requirements Solid Waste Rule), the EPA published a 1. Provisions that are not part of the beyond those imposed by state law. final which determined that for states RCRA subtitle C program because they Therefore, this action is not subject to such as North Dakota that had adopted are ‘‘broader in scope’’ than RCRA review by OMB. This action is not the 2015 DSW rule, those state subtitle C (see 40 CFR 271.1(i)); subject to Executive Order 13771 (82 FR provisions will be considered broader in 2. Federal rules for which North 9339, February 3, 2017) because today’s scope than the federal program as it Dakota is not authorized, but which authorization and codification of North pertains to the specific vacated have been incorporated into the state Dakota’s revised hazardous waste provisions. regulations because of the way the state program under RCRA is exempted adopted federal regulations by under Executive Order 12866. II. Incorporation by Reference reference; Accordingly, I certify that this action In the proposed rule published on 3. State procedural and enforcement will not have a significant economic June 5, 2018 (83 FR 25986), the EPA authorities which are necessary to impact on a substantial number of small also proposed to codify the EPA’s establish the ability of the state’s entities under the Regulatory Flexibility authorization of North Dakota’s base program to enforce compliance, but Act (5 U.S.C. 601 et seq.). Because this hazardous waste management program which do not supplant the federal action authorizes and codifies pre- and the state’s revisions to that program. statutory enforcement and procedural existing requirements under state law In this action, the EPA is amending 40 authorities. and does not impose any additional CFR 272.1751 to incorporate by 4. Federal rules which North Dakota enforceable duty beyond that required reference North Dakota’s authorized adopted, but which were vacated by the by state law, it does not contain any hazardous waste statutes and U.S. Court of Appeals for the District of unfunded mandate or significantly or regulations. In accordance with the Columbia Circuit (D.C. Cir. No. 09– uniquely affect small governments, as requirements of 1 CFR 51.5, the EPA is 1038, rulings dated July 7, 2017, and described in the Unfunded Mandates incorporating by reference North March 6, 2018). Reform Act of 1995 (2 U.S.C. 1531– Dakota’s authorized hazardous waste State provisions that are ‘‘broader in 1538). For the same reason, this action statutes and regulations as described in scope’’ than the federal program are not also does not significantly or uniquely Section I, above. The EPA has made, incorporated by reference in 40 CFR affect the communities of tribal and will continue to make, these part 272. For reference and clarity, the governments, as specified by Executive materials generally available EPA lists in 40 CFR 272.1751(c)(3) the Order 13175 (65 FR 67249, November 9, electronically through http:// North Dakota statutory provisions that 2000). This action will not have www.regulations.gov and in hard copy are ‘‘broader in scope’’ than the federal substantial direct effects on the states, at the appropriate EPA office (see the program, and which are not part of the on the relationship between the national

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government and the states, or on the and adverse human health or Conservation and Recovery Act and is distribution of power and environmental effects of their programs, amending 40 CFR part 272 as follows: responsibilities among the various policies, and activities on minority levels of government, as specified in populations and low-income PART 272—APPROVED STATE Executive Order 13132 (64 FR 43255, populations in the United States. HAZARDOUS WASTE MANAGEMENT August 10, 1999), because it merely Because this rule authorizes and PROGRAMS authorizes and codifies state codifies pre-existing state rules which ■ 1. The authority citation for part 272 requirements as part of the state RCRA are at least equivalent to, and no less continues to read as follows: hazardous waste program without stringent than existing federal altering the relationship or the requirements, and imposes no Authority: Sections 2002(a), 3006, and distribution of power and additional requirements beyond those 7004(b) of the Solid Waste Disposal Act, as responsibilities established by RCRA. imposed by state law, and there are no amended by the Resource Conservation and This action also is not subject to Recovery Act of 1976, as amended, 42 U.S.C. anticipated significant adverse human 6912(a), 6926, and 6974(b). Executive Order 13045 (62 FR 19885, health or environmental effects, the rule April 23, 1997), because it is not is not subject to Executive Order 12898. ■ 2. Revise § 272.1751 to read as economically significant, and it does not The Congressional Review Act, 5 follows: make decisions based on environmental U.S.C. 801–808, generally provides that health or safety risks. This action is not § 272.1751 North Dakota State- before a rule may take effect, the agency administered program: Final authorization. subject to Executive Order 13211, promulgating the rule must submit a ‘‘Actions Concerning Regulations That (a) History of the State of North rule report, which includes a copy of Dakota authorization. Pursuant to Significantly Affect Energy Supply, the rule to each House of the Congress Distribution, or Use’’ (66 FR 28355, May section 3006(b) of RCRA, 42 U.S.C. and to the Comptroller General of the 6926(b), North Dakota has final 22, 2001), because it is not a significant United States. The EPA will submit a regulatory action under Executive Order authorization for the following elements report containing this document and as submitted to the EPA in North 12866. other required information to the U.S. Under RCRA 3006(b), the EPA grants Dakota’s base program application for Senate, the U.S. House of a state’s application for authorization as final authorization which was approved Representatives, and the Comptroller long as the state meets the criteria by the EPA effective on October 19, General of the United States prior to required by RCRA. It would thus be 1984. Subsequent program revision publication in the Federal Register. A inconsistent with applicable law for the applications were approved effective on major rule cannot take effect until 60 EPA, when it reviews a state August 24, 1990, July 6, 1992, June 6, days after it is published in the Federal authorization application, to require the 1994, March 20, 2000, November 25, Register. This action is not a ‘‘major use of any particular voluntary 2005, April 14, 2008, and October 30, rule’’ as defined by 5 U.S.C. 804(2). This consensus standard in place of another 2018. standard that otherwise satisfies the action will be effective October 30, (b) Enforcement authority. The State requirements of RCRA. Thus, the 2018. of North Dakota has primary requirements of section 12(d) of the List of Subjects responsibility for enforcing its National Technology Transfer and hazardous waste management program. Advancement Act of 1995 (15 U.S.C. 40 CFR Part 271 However, the EPA retains the authority 272 note) do not apply. As required by Environmental protection, to exercise its inspection and section 3 of Executive Order 12988 (61 Administrative practice and procedure, enforcement authorities in accordance FR 4729, February 7, 1996), in issuing Confidential business information, with sections 3007, 3008, 3013, 7003 of this action, the EPA has taken the Hazardous waste, Hazardous waste RCRA, 42 U.S.C. 6927, 6928, 6934, necessary steps to eliminate drafting transportation, Indian lands, 6973, and any other applicable statutory errors and ambiguity, minimize Intergovernmental relations, Penalties, and regulatory provisions, regardless of potential litigation and provide a clear Reporting and recordkeeping whether the state has taken its own legal standard for affected conduct. The requirements. actions, as well as in accordance with EPA has complied with Executive Order other statutory and regulatory 12630 (53 FR 8859, March 15, 1988) by 40 CFR Part 272 provisions. examining the takings implications of Environmental protection, Hazardous (c) State Statutes and Regulations— the action in accordance with the materials transportation, Hazardous (1) Incorporation by reference. The ‘‘Attorney General’s Supplemental waste, Incorporation by reference, North Dakota statutes and regulations Guidelines for the Evaluation of Risk Intergovernmental relations, Water cited in paragraph (c)(1)(i) of this and Avoidance of Unanticipated pollution control, Water supply. section are incorporated by reference as Takings’’ issued under the executive part of the hazardous waste Authority: This rule is issued under the order. This action does not impose an management program under Subtitle C authority of Sections 2002(a), 3006 and of RCRA, 42 U.S.C. 6921 et seq. This information collection burden under the 7004(b) of the Solid Waste Disposal Act as provisions of the Paperwork Reduction amended, 42 U.S.C. 6912(a), 6926, 6974(b). incorporation by reference is approved Act of 1995 (44 U.S.C. 3501 et seq.). by the Director of the Federal Register ‘‘Burden’’ is defined at 5 CFR 1320.3(b). Dated: October 24, 2018 in accordance with 5 U.S.C. 552(a) and Executive Order 12898 (59 FR 7629, Douglas Benevento, 1 CFR part 51. You may obtain copies February 16, 1994) establishes federal Regional Administrator, EPA Region 8. of the North Dakota regulations that are executive policy on environmental For the reasons set forth in the incorporated by reference in this justice. Its main provision directs preamble, under the authority at 42 paragraph from the North Dakota federal agencies, to the greatest extent U.S.C. 6912(a), 6926, and 6974(b), EPA Legislative Council, Second Floor, State practicable and permitted by law, to is granting final authorization under Capitol, 600 E Boulevard Avenue, make environmental justice part of their part 271 to the State of North Dakota for Bismarck, North Dakota 58505, phone mission by identifying and addressing, revisions to its hazardous waste (701) 328–2916. You may inspect a copy as appropriate, disproportionately high program under the Resource at EPA Region 8, 1595 Wynkoop Street,

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Denver, Colorado, phone number (303) (3) Related legal provisions. The (iii) North Dakota has adopted the 312–6231, or at the National Archives following statutory and regulatory following federal provisions from the and Records Administration (NARA). provisions are broader in scope than the Revisions to the Definition of Solid For information on the availability of federal program, are not part of the Waste Rule, published January 13, 2015, this material at NARA, call (202) 741– authorized program, are not which have since been vacated by the 6030, or go to: http:/www.archives.gov/ incorporated by reference, and are not U.S. Court of Appeals for the District of federal-register/cfr/ibr-locations.html. federally enforceable: Columbia Circuit in Am. Petroleum Inst. (i) The Binder entitled ‘‘EPA- (i) North Dakota Century Code, 2012 v. EPA, 862 F.3d 50 (D.C. Cir. 2017) and Approved North Dakota Statutory and Replacement, Volume 4A, Chapter 23– Am. Petroleum Inst. v. EPA, No. 09– Regulatory Requirements Applicable to 01 ‘‘State Department of Health,’’ 1038 (D.C. Cir. Mar. 6, 2018) (vacating the Hazardous Waste Management Section 23–01–04.1(6). both the Factor 4 Legitimacy Test and Program,’’ dated April 2018. (ii) North Dakota Century Code, the Verified Recycler Exclusion aspects (ii) [Reserved] Volume 4A, 2012 Replacement. Chapter of the 2015 DSW Rule): One criterion in (2) Legal basis. The EPA considered 23–20.3 ‘‘Hazardous Waste the determination of whether recycling the following statutes and regulations in Management,’’ Sections 23–20.3–02(1); is legitimate at 40 CFR 260.43(a)(4); the evaluating the state program but is not 23–20.3–05.1; 23–20.3–05.2; and 23– verified recycler exclusion, which 20.3–05.3. incorporating them herein for allowed generators to send their enforcement purposes: (iii) North Dakota Administrative Code, Article 33–24, ‘‘Hazardous Waste hazardous secondary materials to (i) North Dakota Century Code Management,’’ as amended through certain reclaimers at 40 CFR (NDCC), Volume 13A, 2012 January 1, 2016, Sections 33–24–01– 261.4(a)(24); and the associated Replacement, North Dakota 09.4; 33–24–01–10.4; 33–24–01–19.1.d; provisions at 40 CFR 260.30(d) and Constitution, Article XI: Sections 5 and 33–24–02–04.1.y; 33–24–03–03.4; 33– 260.31(d), which address the criteria in 6. 24–04–02.3; 33–24–05–02 second the variance determination for (ii) North Dakota Century Code, sentence; 33–24–06–14.3.a(4); and 33– exceptions to the classification of Volume 4A, 2012 Replacement. Chapter 24–06–21. hazardous secondary materials as a 23–01 ‘‘State Department of Health,’’ (iv) North Dakota’s hazardous waste solid waste. As a result, those state Section 23–01–04.1; Chapter 23–20.3 regulations set forth additional provisions will be considered broader in ‘‘Hazardous Waste Management,’’ transporter requirements including scope than the federal program, as it Sections 23–20.3–01, 23–20.3–02 permit requirements at 33–24–04–02. pertains to the specific vacated introductory paragraph, (2), (3) through The transporter permit requirements are provisions, and are listed in (8), (10), (13) through (16), and (18); 23– broader in scope than the federal § 272.1751(c)(3)(iii) with the rest of 20.3–03; 23–20.3–04; 23–20.3–05(3), (5), program. North Dakota’s broader in scope (6), and (8); 23–20.3–06 through 23– (4) Unauthorized State amendments regulatory provisions). 20.3–10; and Chapter 23–29 ‘‘Solid and provisions. (i) North Dakota has (5) Memorandum of Agreement. The Waste Management and Land partially or fully adopted, but is not Memorandum of Agreement between Protection,’’ Section 23–29–04. authorized to implement, the federal the EPA Region 8 and the State of North (iii) North Dakota Century Code, rule published in the Federal Register Dakota, signed by the Environmental Volume 4A, 2015 Pocket Supplement. on October 22, 1998, titled Standards Health Section of the North Dakota Chapter 23–01 ‘‘State Department of Applicable to Owners and Operators of Department of Health on July 18, 2016, Health,’’ Section 23–01–36. Closed and Closing Hazardous Waste although not incorporated by reference, (iv) North Dakota Century Code, Management Facilities: Post-Closure is referenced as part of the authorized Volume 5, 2012 Replacement. Chapter Permit Requirement and Closure hazardous waste management program 28–32 ‘‘Administrative Agencies Process; Final Rule (HSWA/non- under subtitle C of RCRA, 42 U.S.C. Practice Act,’’ Section 28–32–21.1 HSWA). The EPA will continue to 6921 et seq. ‘‘Actions against administrative implement the federal HSWA agencies—Attorney’s fees and costs.’’ requirements for which North Dakota is (6) Statement of Legal Authority. (v) North Dakota Century Code, not authorized until the state receives ‘‘Attorney General’s Statement: Volume 6, 2012 Replacement. Chapter specific authorization for those Hazardous Waste Management 32–40 ‘‘Environmental Law requirements. Program’’ signed by the Attorney Enforcement,’’ Sections 32–40–03 (ii) The following federal rules are not General of North Dakota on June 8, through 32–40–11. delegable to states. North Dakota has 1984, and revisions, supplements, and (vi) North Dakota Century Code, adopted these provisions and left the addenda to that Statement dated Volume 9A, 2012 Replacement, as authority to the EPA for implementation February 22, 1989, February 11, 1984, amended by the 2015 Pocket and enforcement: Imports and Exports October 13, 1999, April 23, 2004, Supplement. Chapter 44–04 ‘‘Duties, of Hazardous Waste: Implementation of August 19, 2004, and December 5, 2016, records and meetings,’’ Sections 44–04– OECD Council Decision C(92)39 although not incorporated by reference, 18 through 19.1. Concerning the Control of Transfrontier are referenced as part of the authorized (vii) North Dakota Administrative Movements of Wastes Destined for hazardous waste management program Code (NDAC), Article 33–24, Hazardous Recovery Operations, published April under subtitle C of RCRA, 42 U.S.C. Waste Management, as amended 12, 1996; and Revisions to the 6921 et seq. through January 1, 2016. Sections 33– Requirements for: Transboundary (7) Program Description. The Program 24–01–15; 33–24–01–16; 33–24–06–05, Shipments of Hazardous Wastes Description and any other materials except .2.c; 33–24–06–06.2; 33–24–06– Between OECD Member Countries, submitted as supplements, although not 09; 33–24–06–15.1.6 through .3.b; 33– Export Shipments of Spent Lead-Acid incorporated by reference, are 24–07–03.4; 33–24–07–04 through 33– Batteries, Submitting Exception Reports referenced as part of the authorized 24–07–14; 33–24–07–25 through 33–24– for Export Shipments of Hazardous hazardous waste management program 07–27; and 33–24–07–40 through 33– Wastes, and Imports of Hazardous under subtitle C of RCRA, 42 U.S.C. 24–07–54. Wastes, published January 8, 2010. 6921 et seq.

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■ 3. Appendix A to part 272 is amended Chapter 33–24–04—Standards for 33–24–05–750 through 33–24–05–756; 33– by revising the listing for ‘‘North Transporters: Sections 33–24–04–01, except 24–05–760 through 33–24–05–762; 33–24– Dakota’’ to read as follows: .4 and Note following paragraph .3.b; 33–24– 05–770, except .4; 33–24–05–780; 33–24–05– 04–02.1, except the phrase ‘‘, a transporter 781; 33–24–05–800 through 33–24–05–802; Appendix A to Part 272—State permit, and a registration certificate’’; 33–24– 33–24–05–820 through 33–24–05–826; 33– Requirements 04–02.2, except the phrases ‘‘and a 24–05–850; 33–24–05–855 through 33–24– registration certificate, or a transporter * * * * * 05–857; 33–24–05–860; 33–24–05–865; 33– permit,’’ in the first sentence, and ‘‘and issue 24–05–866; 33–24–05–870; 33–24–05–875; North Dakota a registration certificate’’ in the second 33–24–05–880; 33–24–05–885; 33–24–05– sentence; and 33–24–04–03 through 33–24– 890; 33–24–05–895 through 33–24–05–900; (a) The statutory provisions include: North 04–08. Dakota Century Code (NDCC), Volume 4A, Chapter 33–24–05—Standards for 33–24–05–905; 33–24–05–910; 33–24–05– 2012 Replacement. Chapter 23–20.3 Treatment, Storage, and Disposal Facilities 915; 33–24–05–916; 33–24–05–950; 33–24– ‘‘Hazardous Waste Management,’’ Sections and for the Management of Specific 05–951; 33–24–05–960; 33–24–05–961; 33– 23–20.3–05(1), (2), (4), (7), and (9). Copies of Hazardous Waste and Specific Types of 24–05–963 through 33–24–05–968; 33–24– the North Dakota statutes that are Hazardous Waste Management Facilities: 05–980 through 33–24–05–986; 33–24–05– incorporated by reference are available from Sections 33–24–05–01; 33–24–05–02, except 990 through 33–24–05–998; 33–24–05–1010 Matthew Bender & Company Inc., 701 E the second sentence; 33–24–05–03, except through 33–24–05–1016; 33–24–05–1020; Water Street, Charlottesville, VA 22902– 33–24–05–03.1; 33–24–05–04 through 33– 33–24–05–1031; 33–24–05–1040 through 33– 5389, phone number: (800) 833–9844. 24–05–10; 33–24–05–15 through 33–24–05– 24–05–1043; 33–24–05–1045 through 33–24– (b) The regulatory provisions include: 20; 33–24–05–26 through 33–24–05–31; 33– 05–1047; 33–24–05–1060 through 33–24–05– North Dakota Administrative Code (NDAC), 24–05–37; 33–24–05–38, except .1.c and .4; 1063; 33–24–05–1067; 33–24–05–1068; 33– Article 33–24, as revised January 1, 2016, 33–24–05–39 through 33–24–05–44; 33–24– 24–05–1071; 33–24–05–1080 through 33–24– except reserved provisions. 05–47 through 33–24–05–69; 33–24–05–74 05–1087; 33–24–05–1100 through 33–24–05– Chapter 33–24–01—General provisions: through 33–24–05–81; 33–24–05–89 through 1114; 33–24–05–1130 through 33–24–05– Sections 33–24–01–01 through 33–24–01–04, 33–24–05–98; 33–24–05–103 through 33–24– 1138; and Appendices I through VIII, X 33–24–01–05, except .2.k and .7.a; 33–24– 05–115; 33–24–05–118 through 33–24–05– through XIII, XV through XXIV, and XXVI 01–06 through 33–24–01–09; 33–24–01–10, 128; 33–24–05–130 through 33–24–05–138; through XXIX. except .4.f; 33–24–01–11 through 33–24–01– 33–24–05–144 through 33–24–05–151; 33– Chapter 33–24–06—Permits: Sections 33– 14; 33–24–01–17; 33–24–01–18; and 33–24– 24–05–160 through 33–24–05–170; 33–24– 01–19, except .1.d. 05–176 through 33–24–05–188; 33–24–05– 24–06–01; 33–24–06–02, 33–24–06–03, Chapter 33–24–02—Identification and 201 through 33–24–05–204; 33–24–05–230, except Note following paragraph .1.a.(2); 33– Listing of Hazardous Waste: Sections 33–24– except .2.c; 33–24–05–235, except .1/Table 24–06–04; 33–24–06–05.2.c; 33–24–06–06.1; 02–01 through 33–24–02–03; 33–24–02–04, entries (6) and (7); 33–24–05–250 through 33–24–06–07; 33–24–06–08; 33–24–06–10 except .1.y; 33–24–02–05; 33–24–02–06, 33–24–05–253; 33–24–05–256; 33–24–05– through 33–24–06–13; 33–24–06–14, except except .1.e; 33–24–02–07 through 33–24–02– 258; 33–24–05–265; 33–24–05–266; 33–24– .3.a.(4); 33–24–06–15 introductory paragraph 10; 33–24–02–11, except the phrase ‘‘or a 05–270 through 33–24–05–281; 33–24–05– through .1.a; 33–24–06–16.5 through .7; 33– miniflash continuously closed cup tester, 282, except .2; 33–24–05–283; 33–24–05– 24–06–17 through 33–24–06–20; 33–24–06– using the test method specified in American 284.8 through .13; 33–24–05–285; 33–24–05– 30 through 33–24–06–35; 33–24–06–45; 33– Society for Testing and Material D6450–99 286; 33–24–05–288 through 33–24–05–290; 24–06–48; 33–24–06–52; 33–24–06–56; 33– (incorporated by reference in section 33–24– 33–24–05–300 through 33–24–05–303; 33– 24–06–57; 33–24–06–62; 33–24–06–65; 33– 01–05)’’ in paragraph .1.a; 33–24–02–12 24–05–400 through 33–24–05–406; 33–24– 24–06–70; 33–24–06–73; 33–24–06–76; 33– through 33–24–02–19; 33–24–02–25 through 05–420 through 33–24–05–435; 33–24–05– 24–06–80; 33–24–06–85; 33–24–06–100; and 33–24–02–27; 33–24–02–33 through 33–24– 450 through 33–24–05–460; 33–24–05–475 Appendix I to Section 33–24–06–14. 02–42; 33–24–02–50 through 33–24–02–70; through 33–24–05–477; 33–24–05–501 Chapter 33–24–07—Permitting Procedures: 33–24–02–120 through 33–24–02–129; 33– through 33–24–05–506; 33–24–05–525 Sections 33–24–07–01; 33–24–07–02; and 24–02–170 through 33–24–02–175; 33–24– through 33–24–05–537; 33–24–05–550 33–24–07–03, except .4. 02–180 through 33–24–02–194; 33–24–02– through 33–24–05–555; 33–24–05–600; 33– Copies of the North Dakota regulations that 200 through 33–24–02–209; and Appendices 24–05–610 through 33–24–05–612; 33–24– are incorporated by reference are available I, IV, and V. 05–620 through 33–24–05–624; 33–24–05– from North Dakota Legislative Counsel, Chapter 33–24–03—Standards for 630 through 33–24–05–632; 33–24–05–640 Second Floor, State Capitol, 600 East Generators: Sections 33–24–03–01, except .4; through 33–24–05–647; 33–24–05–650 Boulevard Avenue, Bismarck, North Dakota 33–24–03–02; 33–24–03–03.1 and .2; 33–24– through 33–24–05–667; 33–24–05–670 58505, phone number: (701) 328–2916. 03–03.3 except the phrase ‘‘and a transporter through 33–24–05–675; 33–24–05–680; 33– permit’’; 33–24–03–04 through 33–24–03–24; 24–05–681; 33–24–05–701 through 33–24– * * * * * 33–24–03–30; 33–24–03–40; 33–24–03–60 05–705; 33–24–05–708 through 33–24–05– [FR Doc. 2018–23633 Filed 10–29–18; 8:45 am] through 33–24–03–77; and Appendix I. 720; 33–24–05–730 through 33–24–05–740; BILLING CODE 6560–50–P

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Proposed Rules Federal Register Vol. 83, No. 210

Tuesday, October 30, 2018

This section of the FEDERAL REGISTER Drinking Water of Animals to provide ADDRESSES: For access to the docket, go contains notices to the public of the proposed for the safe use of silicon dioxide as an to https://www.regulations.gov and issuance of rules and regulations. The anticaking agent for the use with zinc- insert the docket number, found in purpose of these notices is to give interested L-selenomethionine as a feed persons an opportunity to participate in the brackets in the heading of this rule making prior to the adoption of the final component. In an earlier notice of document, into the ‘‘Search’’ box and rules. petition (79 FR 49465, August 21, 2014), follow the prompts; and/or go to the the use of silicon dioxide was omitted. Dockets Management Staff, 5630 Fishers The petitioner has claimed that this Lane, Rm. 1061, Rockville, MD 20852. DEPARTMENT OF HEALTH AND action is categorically excluded under HUMAN SERVICES 21 CFR 25.32(r) because it is of a type FOR FURTHER INFORMATION CONTACT: that does not individually or Chelsea Trull, Center for Veterinary Food and Drug Administration cumulatively have a significant effect on Medicine, Food and Drug the human environment. In addition, Administration, 7519 Standish Pl., 21 CFR Part 573 the petitioner has stated that, to their Rockville, MD 20855, 240–402–6729, [email protected]. [Docket No. FDA–2014–F–1184] knowledge, no extraordinary circumstances exist. If FDA determines SUPPLEMENTARY INFORMATION: Under the a categorical exclusion applies, neither Zinpro Corp.; Filing of Food Additive Federal Food, Drug, and Cosmetic Act an environmental assessment nor an Petition (Animal Use) (section 409(b)(5) (21 U.S.C. 348(b)(5))), environmental impact statement is notice is given that a food additive AGENCY: Food and Drug Administration, required. If FDA determines a HHS. categorical exclusion does not apply, we petition (FAP 2291) has been filed by Adisseo France S.A.S., Immeuble ACTION: Notification; petition for will request an environmental ´ ´ rulemaking. assessment and make it available for Antony Parc II, 10 Place du General de public inspection. Gaulle, 92160 Antony, France. The SUMMARY: The Food and Drug petition proposes to amend Title 21 of Dated: October 25, 2018. Administration (FDA or we) is the Code of Federal Regulations (CFR) announcing that Zinpro Corp. has filed Leslie Kux, in part 573 (21 CFR part 573) Food a petition proposing that the food Associate Commissioner for Policy. Additives Permitted in Feed and additive regulations be amended to [FR Doc. 2018–23672 Filed 10–29–18; 8:45 am] Drinking Water of Animals to provide provide for the safe use of silicon BILLING CODE 4164–01–P for the safe use of silicon dioxide as a dioxide as an anticaking agent for the carrier for selenomethionine hydroxy use with zinc-L-selenomethionine as a analogue at a level not to exceed 95 feed component. DEPARTMENT OF HEALTH AND percent of the selenomethionine HUMAN SERVICES DATES: The food additive petition was hydroxy analogue in its packaged form. filed on July 29, 2014. Food and Drug Administration In an earlier notice of petition (80 FR ADDRESSES: For access to the docket, go 48471, August 13, 2015), the use of to https://www.regulations.gov and 21 CFR Part 573 silicon dioxide was omitted. insert the docket number, found in The petitioner has claimed that this [Docket No. FDA–2015–F–2712] brackets in the heading of this action is categorically excluded under document, into the ‘‘Search’’ box and Adisseo France S.A.S.; Filing of Food 21 CFR 25.32(r) because it is of a type follow the prompts; and/or go to the Additive Petition (Animal Use) that does not individually or Dockets Management Staff, 5630 Fishers cumulatively have a significant effect on Lane, Rm. 1061, Rockville, MD 20852. AGENCY: Food and Drug Administration, the human environment. In addition, FOR FURTHER INFORMATION CONTACT: HHS. the petitioner has stated that, to their Carissa Doody, Center for Veterinary ACTION: Notification; petition for knowledge, no extraordinary Medicine, Food and Drug rulemaking. circumstances exist. If FDA determines Administration, 7519 Standish Pl., a categorical exclusion applies, neither Rockville, MD 20855, 240–402–6283, SUMMARY: The Food and Drug an environmental assessment nor an [email protected]. Administration (FDA or we) is environmental impact statement is SUPPLEMENTARY INFORMATION: Under the announcing that Adisseo France S.A.S. required. If FDA determines a Federal Food, Drug, and Cosmetic Act has filed a petition proposing that the categorical exclusion does not apply, we (section 409(b)(5) (21 U.S.C. 348(b)(5))), food additive regulations be amended to will request an environmental notice is given that a food additive provide for the safe use of silicon assessment and make it available for petition (FAP 2285) has been filed by dioxide as a carrier for public inspection. selenomethionine hydroxy analogue at a Zinpro Corp., 10400 Viking Dr., Suite Dated: October 25, 2018. 240, Eden Prairie, MN 55344. The level not to exceed 95 percent of the petition proposes to amend Title 21 of selenomethionine hydroxy analogue in Leslie Kux, the Code of Federal Regulations (CFR) its packaged form. Associate Commissioner for Policy. in part 573 (21 CFR part 573) Food DATES: The food additive petition was [FR Doc. 2018–23671 Filed 10–29–18; 8:45 am] Additives Permitted in Feed and filed on June 18, 2015. BILLING CODE 4164–01–P

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DEPARTMENT OF THE TREASURY to present oral comments at the hearing the cross-references to the old that submitted written comments by implementing regulations in the MSW Internal Revenue Service October 9, 2018, must submit an outline Landfills EG to harmonize with the of the topics to be addressed and the proposed new timing and completeness 26 CFR Part 1 amount of time to be devoted to each requirements for state and federal plans. topic by Thursday, November 15, 2018. [REG–104397–18] DATES: A period of 10 minutes is allotted to Comments. Comments must be RIN 1545–BO74 each person for presenting oral received on or before December 14, comments. After the deadline for 2018. Additional First Year Depreciation receiving outlines has passed, the IRS Public hearing. If anyone contacts us Deduction; Hearing will prepare an agenda containing the requesting a public hearing on or before schedule of speakers. Copies of the November 5, 2018, we will hold a AGENCY: Internal Revenue Service (IRS), agenda will be made available, free of hearing. Additional information about Treasury. charge, at the hearing or by contacting the hearing, if requested, will be ACTION: Proposed rule; notice of hearing. the Publications and Regulations Branch published in a subsequent Federal at (202) 317–6901 (not a toll-free SUMMARY: This document provides a Register document and posted at number). notice of public hearing on proposed https://www.epa.gov/stationary-sources- Because of access restrictions, the IRS air-pollution/municipal-solid-waste- regulations relating to guidance will not admit visitors beyond the regarding the additional first year landfills-new-source-performance- immediate entrance area more than 30 standards. See SUPPLEMENTARY depreciation deduction under section minutes before the hearing starts. For 168(k) of the Internal Revenue Code. INFORMATION for information on information about having your name requesting and registering for a public DATES: The public hearing is being held placed on the building access list to hearing. on Wednesday, November 28, 2018, at attend the hearing, see the FOR FURTHER ADDRESSES: 10:00 a.m. The IRS must receive INFORMATION CONTACT section of this Comments. Submit your comments, speakers’ outlines of the topics to be document. discussed at the public hearing by identified by Docket ID No. EPA–HQ– Thursday, November 15, 2018. Martin V. Franks, OAR–2018–0695 at https:// www.regulations.gov. Follow the online ADDRESSES: The public hearing is being Chief, Publications and Regulations Branch, instructions for submitting comments. held in the IRS Auditorium, Internal Legal Processing Division, Associate Chief Counsel (Procedure and Administration). Once submitted, comments cannot be Revenue Service Building, 1111 [FR Doc. 2018–23636 Filed 10–29–18; 8:45 am] edited or removed from Regulations.gov. Constitution Avenue NW, Washington, See SUPPLEMENTARY INFORMATION for DC 20224. Due to building security BILLING CODE 4830–01–P detail about how the EPA treats procedures, visitors must enter at the submitted comments. Regulations.gov is Constitution Avenue entrance. In our preferred method of receiving addition, all visitors must present a ENVIRONMENTAL PROTECTION comments. However, the following valid photo identification to enter the AGENCY other submission methods are also building. 40 CFR Part 60 accepted: Send Submissions to CC:PA:LPD:PR • Email: [email protected]. (REG–104397–18), Room 5205, Internal [EPA–HQ–OAR–2018–0695; FRL–9985–94– OAR] Include Docket ID No. EPA–HQ–OAR– Revenue Service, P.O. Box 7604, Ben 2018–0695 in the subject line of the Franklin Station, Washington, DC RIN 2060–AU33 message. 20044. Submissions may be hand- • Fax: (202) 566–9744. Attention delivered Monday through Friday to Adopting Subpart Ba Requirements in Docket ID No. EPA–HQ–OAR–2018– CC:PA:LPD:PR (REG–104397–18), Emission Guidelines for Municipal 0695. Couriers Desk, Internal Revenue Solid Waste Landfills • Mail: To ship or send mail via the Service, 1111 Constitution Avenue NW, United States Postal Service, use the Washington, DC 20224 or sent AGENCY: Environmental Protection Agency (EPA). following address: U.S. Environmental electronically via the Federal Protection Agency, EPA Docket Center, ACTION: Proposed rule. eRulemaking Portal at Docket ID No. EPA–HQ–OAR–2018– www.regulations.gov (IRS REG–104397– SUMMARY: In this action, the 0695, Mail Code 28221T, 1200 18). Environmental Protection Agency (EPA) Pennsylvania Avenue NW, Washington, FOR FURTHER INFORMATION CONTACT: proposes to amend the 2016 Emission DC 20460. Concerning the proposed regulations, Guidelines and Compliance Times for • Hand/Courier Delivery: Use the Elizabeth R. Binder, (202) 317–7005; Municipal Solid Waste Landfills (‘‘MSW following Docket Center address if you concerning submissions of comments, Landfills EG’’). The requirements for are using express mail, commercial the hearing and/or to be placed on the state and federal plans implementing delivery, hand delivery, or courier: EPA building access list to attend the the MSW Landfills EG were adopted Docket Center, EPA WJC West Building, hearing, Regina Johnson at (202) 317– from 1975 regulations, referred to herein Room 3334, 1301 Constitution Avenue 6901 (not toll-free numbers). as the ‘‘old implementing regulations,’’ NW, Washington, DC 20004. Delivery SUPPLEMENTARY INFORMATION: The which are cross-referenced in the MSW verification signatures will be available subject of the public hearing is the Landfill EG. In a separate regulatory only during regular business hours. notice of proposed rulemaking (REG– proposal published in the Federal FOR FURTHER INFORMATION CONTACT: For 104397–18) that was published in the Register in August 2018, the EPA questions about this proposed action, Federal Register on Wednesday, August proposed changes to modernize the old contact Andrew Sheppard, Sector 8, 2018 (83 FR 39292). implementing regulations governing Policies and Programs Division (E143– The rules of 26 CFR 601.601(a)(3) emission guidelines under a new 03), Office of Air Quality Planning and apply to the hearing. Persons who wish subpart. This action proposes to update Standards, U.S. Environmental

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Protection Agency, Research Triangle additional submission methods, the full OAQPS, U.S. Environmental Protection Park, North Carolina 27711; telephone EPA public comment policy, Agency, Research Triangle Park, North number: (919) 541–4161; fax number: information about CBI or multimedia Carolina 27711, Attention Docket ID No. (919) 541–0516; and email address: submissions, and general guidance on EPA–HQ–OAR–2018–0695. [email protected]. making effective comments, please visit Preamble Acronyms and SUPPLEMENTARY INFORMATION: https://www.epa.gov/dockets/ Abbreviations. We use multiple Public hearing. Please contact commenting-epa-dockets. acronyms and terms in this preamble. Virginia Hunt at (919) 541–0832 or by The https://www.regulations.gov While this list may not be exhaustive, to email at [email protected] to website allows you to submit your ease the reading of this preamble and for request a public hearing, to register to comment anonymously, which means reference purposes, the EPA defines the speak at the public hearing, or to inquire the EPA will not know your identity or following terms and acronyms here: as to whether a public hearing will be contact information unless you provide CAA Clean Air Act held. it in the body of your comment. If you CBI Confidential Business Information Docket. The EPA has established a send an email comment directly to the CFR Code of Federal Regulations docket for this rulemaking under Docket EPA without going through https:// EG Emission Guidelines ID No. EPA–HQ–OAR–2018–0695. All www.regulations.gov, your email EPA Environmental Protection Agency address will be automatically captured MSW Municipal Solid Waste documents in the docket are listed in NAICS North American Industry Regulations.gov. Although listed, some and included as part of the comment that is placed in the public docket and Classification System information is not publicly available, made available on the internet. If you NTTAA National Technology Transfer and e.g., Confidential Business Information Advancement Act submit an electronic comment, the EPA (CBI) or other information whose OAQPS Office of Air Quality Planning and recommends that you include your disclosure is restricted by statute. Standards name and other contact information in Certain other material, such as OMB Office of Management and Budget the body of your comment and with any copyrighted material, is not placed on PRA Paperwork Reduction Act digital storage media you submit. If the RFA Regulatory Flexibility Act the internet and will be publicly EPA cannot read your comment due to SIP State Implementation Plan available only in hard copy. Publicly technical difficulties and cannot contact UMRA Unfunded Mandates Reform Act available docket materials are available you for clarification, the EPA may not U.S.C. United States Code either electronically in Regulations.gov be able to consider your comment. Organization of this Document. The or in hard copy at the EPA Docket Electronic files should not include information in this preamble is Center, Room 3334, EPA WJC West special characters or any form of organized as follows: Building, 1301 Constitution Avenue encryption and be free of any defects or I. General Information NW, Washington, DC. The Public viruses. For additional information Reading Room is open from 8:30 a.m. to A. Does this action apply to me? about the EPA’s public docket, visit the B. Where can I get a copy of this document 4:30 p.m., Monday through Friday, EPA Docket Center homepage at https:// and other related information? excluding legal holidays. The telephone www.epa.gov/dockets. II. Background number for the Public Reading Room is Submitting CBI. Do not submit III. What actions are we proposing? (202) 566–1744, and the telephone information containing CBI to the EPA IV. Statutory and Executive Order Reviews number for the EPA Docket Center is through https://www.regulations.gov or A. Executive Order 12866: Regulatory (202) 566–1742. email. Clearly mark the part or all of the Planning and Review and Executive Instructions. Direct your comments to Order 13563: Improving Regulation and information that you claim to be CBI. Regulatory Review Docket ID No. EPA–HQ–OAR–2018– For CBI information on any digital 0695. The EPA’s policy is that all B. Executive Order 13771: Reducing storage media that you mail to the EPA, Regulation and Controlling Regulatory comments received will be included in mark the outside of the digital storage Costs the public docket without change and media as CBI and then identify C. Paperwork Reduction Act (PRA) may be made available online at https:// electronically within the digital storage D. Regulatory Flexibility Act (RFA) www.regulations.gov, including any media the specific information that is E. Unfunded Mandates Reform Act personal information provided, unless claimed as CBI. In addition to one (UMRA) the comment includes information complete version of the comments that F. Executive Order 13132: Federalism claimed to be CBI or other information include information claimed as CBI, you G. Executive Order 13175: Consultation and Coordination With Indian Tribal whose disclosure is restricted by statute. must submit a copy of the comments Do not submit information that you Governments that do not contain the information H. Executive Order 13045: Protection of consider to be CBI or otherwise claimed as CBI directly to the public Children From Environmental Health protected through https:// docket through the procedures outlined Risks and Safety Risks www.regulations.gov or email. This type in Instructions above. If you submit any I. Executive Order 13211: Actions of information should be submitted by digital storage media that does not Concerning Regulations That mail as discussed below. contain CBI, mark the outside of the Significantly Affect Energy Supply, The EPA may publish any comment digital storage media clearly that it does Distribution, or Use received to its public docket. not contain CBI. Information not marked J. National Technology Transfer and Multimedia submissions (audio, video, as CBI will be included in the public Advancement Act (NTTAA) etc.) must be accompanied by a written K. Executive Order 12898: Federal Actions docket and the EPA’s electronic public To Address Environmental Justice in comment. The written comment is docket without prior notice. Information Minority Populations and Low-Income considered the official comment and marked as CBI will not be disclosed Populations should include discussion of all points except in accordance with procedures you wish to make. The EPA will set forth in 40 Code of Federal I. General Information generally not consider comments or Regulations (CFR) part 2. Send or comment contents located outside of the deliver information identified as CBI A. Does this action apply to me? primary submission (i.e., on the Web, only to the following address: OAQPS Table 1 of this preamble lists the cloud, or other file sharing system). For Document Control Officer (C404–02), source categories that may be affected

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by this proposal. Table 1 is not intended that this proposed action is likely to promulgated, will be applicable to the to be exhaustive, but rather provides a affect. The proposed amendment, once affected sources. guide for readers regarding the entities

TABLE 1—SOURCE CATEGORIES AFFECTED BY THIS PROPOSED ACTION

Source category NAICS code 1 Examples of affected sources

State, local, and tribal government agencies ...... 924119 Administration of air and water resource and solid waste management programs. 1 North American Industry Classification System.

B. Where can I get a copy of this incorporated by the MSW Landfills EG, recognizes that, without further action, document and other related the EPA had 4 months to approve or the promulgation of the proposed new information? disapprove a state plan after receipt of implementing regulations would not be In addition to being available in the a plan or plan revision, 40 CFR 60.27(b), sufficient to change the timing docket, an electronic copy of this action and 6 months to issue federal plans for requirements for the MSW Landfills EG, is available on the internet. Following states that failed to submit approved even though it is an ongoing CAA signature by the EPA Administrator, the plans after the due date for state plans, section 111(d) action. This is because EPA will post a copy of this proposed 40 CFR 60.27(c)–(d). the MSW Landfills EG includes a cross- action at https://www.epa.gov/ On August 31, 2018, as part of the reference to the old implementing stationary-sources-air-pollution/ proposed Affordable Clean Energy regulations, as well as a specific (ACE) rule (a CAA section 111(d)-rule municipal-solid-waste-landfills-new- deadline for the submission of state addressing greenhouse gas emissions source-performance-standards. plans that was based on the timing Following publication in the Federal from fossil-fuel-fired electric generating units), the EPA proposed revisions to requirements in the old implementing Register, the EPA will post the Federal regulations. The EPA is proposing to Register version of the proposal and key the old implementing regulations for all CAA section 111(d) emission guidelines amend the cross-references and technical documents at this same deadline in the MSW Landfills EG to website. (83 FR 44746). Specifically, the proposed ACE rule included a new align with the proposed timing II. Background regulation at 40 CFR part 60, subpart Ba requirements in 40 CFR part 60, subpart On August 29, 2016, the EPA (‘‘proposed new implementing Ba.2 The EPA notes that, because this published a final rule titled ‘‘Emission regulations’’) that would, among other proposal is predicated on the proposed Guidelines and Compliance Times for things, change the timing requirements timing requirements in 40 CFR part 60, Municipal Solid Waste Landfills’’ (the for the submission of state plans, the subpart Ba, the EPA will have to finalize ‘‘MSW Landfills EG’’), under Clean Air EPA’s review of state plans, and the the relevant sections of 40 CFR part 60, Act (CAA) section 111(d) (81 FR 59276). issuance of federal plans to more closely subpart Ba that pertain to this rule Section 111(d) is the provision of the align the procedures to that provided either prior to or concurrently with CAA that governs the establishment of under CAA section 110 as specified in finalizing this rule. 1 performance standards for existing CAA section 111(d)(1). In addition, the Specifically, the EPA is proposing to sources. The MSW Landfills EG, which proposed new implementing regulations amend the MSW Landfills EG regulatory was promulgated as a new subpart at 40 would include new completeness text in 40 CFR part 60, subpart Cf to CFR part 60, subpart Cf, updated the criteria also modeled after those that adjust the state plan due date from May control requirements and monitoring, apply to state implementation plans reporting, and recordkeeping provisions (SIPs) submitted under CAA section 110 30, 2017, to August 29, 2019, which for existing MSW landfill sources. The (83 FR 44803–44807). aligns with the proposed new timing MSW Landfills EG incorporates by requirements in 40 CFR part 60, subpart cross-reference or direct adoption III. What actions are we proposing? certain requirements for state and In the proposed ACE rule, the EPA 2 40 CFR part 60, subpart Cf would continue to federal plans as specified in 40 CFR part proposed to apply the 40 CFR part 60, cross-reference 40 CFR part 60, subpart B, except 60, subpart B. Subpart B at 40 CFR part subpart Ba timing requirements to all that it would now cross-reference 40 CFR part 60, 60 contains the historic regulations, ‘‘ongoing’’ emission guidelines already subpart Ba with respect to the implementing regulation’s timing requirements. Accordingly, the initially promulgated in 1975 to published under CAA section 111(d) (83 requirements of 40 CFR 60.23 (Adoption and implement CAA section 111(d), that FR 44769). However, the EPA submittal of State plans; public hearings) and 40 established generally applicable CFR 60.27 (Actions by the Administrator) would be procedural and substantive 1 CAA section 111(d) provides: ‘‘The replaced by the requirements proposed in 40 CFR requirements for CAA section 111(d) Administrator shall prescribe regulations which 60.23a and 40 CFR 60.27a, respectively. However, shall establish a procedure similar to that provided the proposed text in 40 CFR 60.23a(a)(1) and regulations (the ‘‘old implementing by section 7410 of this title under which each State 60.27a(e)(1) refer to a notice of availability of a final regulations’’). Under the old shall submit to the Administrator a plan which (A) guideline document that was published under 40 implementing regulations at 40 CFR establishes standards of performance for any CFR 60.22a(a). Because the MSW Landfills EG were 60.23(a) as adopted by the MSW existing source for any air pollutant (i) for which published under 40 CFR 60.22(a), for purposes of air quality criteria have not been issued or which this amendment, the proposed requirements of 40 Landfills EG, state plans were due 9 is not included on a list published under section CFR 60.23a(a)(1) and 40 CFR 60.27a(e)(1) will refer months after the August 29, 2016, 7408(a) of this title or emitted from a source to the final guideline document that was published publication date of the MSW Landfills category which is regulated under section 7412 of under 40 CFR 60.22(a). Additionally, the provisions EG. Thus, states were required to submit this title but (ii) to which a standard of performance of 40 CFR 60.27a(e)(2) that specify when the EPA under this section would apply if such existing may apply less stringent emission standards or their plans to the EPA by May 30, 2017. source were a new source, and (B) provides for the longer compliance schedules will continue to See 40 CFR 60.30f(b). Under the old implementation and enforcement of such standards reference 40 CFR 60.24(f) instead of 40 CFR implementing regulations as of performance.’’ 60.24a(f).

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Ba.3 For state plans submitted to the to the amount of work, effort, and time is not a sufficient reason to decline to EPA prior to promulgation of these required for developing state plans, the provide a longer period of time for states amendments, the EPA is taking EPA has determined that extending the to develop and submit their plans. The comment on whether to amend the submission date of state plans from 9 EPA further notes that almost all of the MSW Landfills EG regulatory text in 40 months to 3 years is appropriate. states, rather than just a minority, did CFR part 60, subpart Cf to require those Because states have considerable not submit a state plan within the states to resubmit their plans in flexibility in implementing CAA section prescribed 9-month period by May 30, accordance with the provisions of the 111(d), this change would allow states 2017.5 proposed new implementing more time to interact and work with the In addition, as explained in the regulations. This would ensure EPA in the development of state plans proposed ACE rule, CAA section consistent treatment of all states and and minimize the chance of unexpected 111(d)(2)(A) authorizes the EPA to state plans, avoid confusion regarding issues arising that could slow down prescribe a plan for a state ‘‘in cases deadlines, and allow the EPA to eventual approval of state plans (83 FR where the State fails to submit a undertake a completeness review for 44769–44771). satisfactory plan.’’ The EPA, therefore, state plans already submitted to the Separate and apart from the is charged with determining whether EPA. Alternatively, the EPA solicits interaction between the text of CAA state plans developed and submitted comment on whether the Agency should section 111(d) and the 1990 under CAA section 111(d)(1) are not require the resubmission of state amendments to CAA section 110, the ‘‘satisfactory.’’ The EPA reiterates the plans submitted prior to promulgation EPA’s experience also has shown that position in the proposed ACE rule that, of these amendments, and, if not, states need more time to submit a plan given the flexibilities that CAA section whether the EPA should still evaluate than provided for in the old 111(d) and emission guidelines the already-submitted plans for implementing regulations at 40 CFR part generally accord to states, and the EPA’s compliance with the proposed new 60, subpart B. When the EPA proposed prior experience on reviewing and completeness criteria. the MSW Landfills EG, some acting on SIPs under CAA section 110, As explained in the proposed ACE commenters objected to the 9-month it is appropriate to extend the period for rule, CAA section 111(d)(1) directs the period to submit a state plan as not the EPA’s review and approval or EPA to promulgate regulations being achievable for a number of disapproval of plans from the 4-month establishing a procedure ‘‘similar to’’ reasons, such as the amount of time period provided in 40 CFR part 60, that under CAA section 110 (governing needed for rule development, public subpart B, to the 12-month period (after the development, submission, and EPA outreach, public notice, and to hold a a determination of completeness, either review of SIPs to address National public hearing for rule adoption. affirmatively by the EPA or by operation Ambient Air Quality Standards) for Commenters recommended allowing of law) provided in the proposed new states to submit plans to the EPA that states varying amounts of time, from 12 implementing regulations. This timeline establish standards of performance for to 24 months, to submit a state plan. would provide adequate time for the existing sources (see 83 FR 44771). The (See https://www.epa.gov/stationary- EPA to review plans and follow notice- old implementing regulations at 40 CFR sources-air-pollution/responses-public- and-comment rulemaking procedures to part 60, subpart B were promulgated in comments-epas-standards-performance- ensure an opportunity for public 1975 (see 40 FR 53346) and have not municipal, at pages 30–33.) In response, comment on the EPA’s proposed action been significantly revised since their the EPA declined to extend the deadline on a state plan (see 83 FR 44771). original promulgation. Notably, the because we thought at that time that a Because the EPA is proposing to apply implementing regulations do not reflect majority of the states would be able to the completeness criteria that are CAA section 111(d) in its current form submit a plan within the prescribed 9- included in the proposed new as amended by Congress in 1977, and do month period and because, ‘‘[f]or states implementing regulations to state plans not reflect CAA section 110 in its that do not submit a state plan, the CAA submitted to implement the MSW current form as amended by Congress in gives the EPA express authority to Landfills EG, it is important that the 1990. As discussed more fully in the implement a federal plan.’’ (Id. at page EPA have the opportunity to undertake ACE proposal, the EPA has determined 30–31.) On further consideration, the a completeness review for all state that certain portions of the EPA has determined that its response to plans.6 Therefore, the EPA is taking implementing regulations do not comments requesting a longer period of comment on whether the states that appropriately align with the direction in time to submit state plans was have already submitted state plans to CAA section 111(d) that the EPA’s inadequate. The Congressional intent implement the MSW Landfills EG regulations be ‘‘similar’’ to the underlying CAA section 111(d) is clear, 4 should resubmit their plans in provisions under CAA section 110. Due and is strengthened by the reference to accordance with the proposed CAA section 110: Implementation of requirements in 40 CFR part 60, subpart 3 The EPA notes that the proposed regulatory text CAA section 111(d) is intended to be Ba. for 40 CFR 60.27a in the proposed ACE rule has a primarily a state-driven process, and the typographical error. The proposed requirements in 40 CFR 60.27a(g)(2)(vi) and (vii) reference 40 CFR existence of federal backstop authority 5 At the present, only California, Arizona, and 60.23 instead of the proposed requirements in 40 New Mexico have submitted a state plan to the CFR 60.23a. See 83 FR 44807. Assuming 40 CFR under CAA section 110 as requiring the EPA to EPA. 60.27(g)(2) is finalized, the error will be corrected establish an identical scheme for the two 6 The ACE proposal states: ‘‘In the case of SIPs in the final rule. provisions. Rather, the EPA interprets the ‘‘similar under CAA section 110(k)(1), EPA promulgated 4 The EPA acknowledges that the procedural and to’’ direction as requiring it to carefully consider the completeness criteria in 1990 at Appendix V to 40 substantive requirements established by Congress major structural features of CAA section 110 and, CFR part 51 (55 FR 5830; February 16, 1990). EPA for the SIP process under CAA section 110 are where appropriate, adopt similar provisions in its proposes to adopt criteria similar to the criteria set considerably more detailed than the corresponding regulations implementing CAA section 111(d). For out at section 2.0 of Appendix V for determining requirements established by Congress for the state the reasons proposed in the ACE rule, the EPA has the completeness of submissions under CAA existing-source performance standards plans under determined that the timeline promulgated in the old section 111(d). EPA notes that the addition of CAA section 111(d). Accordingly, the EPA does not implementing regulations (as incorporated by the completeness criteria in the framework regulations interpret the Congressional direction under CAA MSW Landfills EG) is inappropriately short and does not alter any of the submission requirements section 111(d) to promulgate regulations that a timeline more in harmony with CAA section states already have under any applicable emission establishing a state-plan procedure ‘‘similar to’’ that 110, as amended in 1990, is more appropriate. guideline.’’ 83 FR 44746, 44772.

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Finally, for this proposed action, the state plans cannot be quantified due to already submitted state plans to EPA is reiterating the rationale in the inherent uncertainties, the EPA believes resubmit their plans and impacts of this proposed ACE rule for extending the that they will be minimal and requests proposal.8 timing from 6 months to 2 years for the comment on this. Some facilities may IV. Statutory and Executive Order EPA to promulgate a federal plan for have an incentive to install landfill gas states that fail to submit an approvable collection systems. Landfill gas can be Reviews state plan in response to the MSW recovered and used as an energy source, Additional information about these Landfills EG. This 2-year timeline is either offsetting existing energy costs or statutes and Executive Orders can be consistent with the federal providing a source of revenue. This found at https://www.epa.gov/laws- implementation plan deadline under offers financial advantages for some regulations/laws-and-executive-orders. CAA section 110(c) (see 83 FR 44771) facilities to install landfill gas collection A. Executive Order 12866: Regulatory and would be beneficial to the EPA. systems early in the development of the Planning and Review and Executive Whenever the EPA promulgates a project (i.e., prior to the regulatory Order 13563: Improving Regulation and federal plan, it must follow the requirement date resulting from a state Regulatory Review rulemaking requirements in CAA or federal plan implementing the MSW 307(d). This involves a number of Landfills EG). If facilities have already This action is a significant regulatory potentially time-consuming steps, installed controls, then shifting the date action that was submitted to the Office including coordination with many by which states must submit plans may of Management and Budget (OMB) for offices, developing a comprehensive not have any impact on the actual review. Any changes made in response record, and considering comments collection and control of landfill gas. On to OMB recommendations have been submitted on a proposed plan. In the other hand, some sources may documented in the docket. addition, when states fail to submit a choose to wait until requirements are B. Executive Order 13771: Reducing plan as required under the MSW enacted prior to installing controls. Regulation and Controlling Regulatory Landfills EG, we typically promulgate a While this would not impact the cost of Costs single federal plan that applies to a installing controls, it could impact the number of states. Unlike a federal plan amount of landfill gas captured over the This action is not expected to be developed for a single state, the federal life of the project and increase the net subject to Executive Order 13771 plan developed here may be more cost. because this proposed rule is expected complex and time-intensive since it For states, the costs of complying with to result in no more than de minimis must be tailored to meet the needs of the new timing requirements, which costs. many states. include the new completeness criteria, In summary, under this proposed are likely minimal.7 The proposed C. Paperwork Reduction Act (PRA) rule, which would adopt the timing completeness criteria in 40 CFR part 60, This action does not impose any new requirements in proposed 40 CFR part subpart Ba are based on the criteria in information collection burden under the 60, subpart Ba, states would have until 40 CFR part 51, appendix V that states PRA. OMB has previously approved the August 29, 2019, to submit their state already follow when developing SIPs information collection activities plans (3 years from the effective date of under CAA section 110. Given that the contained in the existing regulations the MSW Landfills EG). After a state has majority of state planning occurs under and has assigned OMB control number submitted its plan, the EPA would have CAA section 110, it is likely that many 2060–0720. Because the burden to 6 months to determine if the plan is states simply comply with the prepare and submit a state plan have complete. If the EPA does not make a completeness criteria in 40 CFR part 51, been fully incorporated into the 2016 determination of completeness within appendix V when developing their CAA MSW Landfills EG, and this action does that period of time, the state plan would section 111(d) state plans, while any not change any of the requirements be deemed complete by operation of states that do not would need to make associated with the stringency of the law, and the EPA would have 12 only minimal adjustments to apply their rule, there are no changes to the additional months to approve or CAA section 110 SIP process in the previously estimated information disapprove the state plan. If the EPA context of CAA section 111(d) state collection burden. determines that the plan is complete, planning. the EPA would have 12 months from the In summary, the purpose of this D. Regulatory Flexibility Act (RFA) date of that determination to approve or proposal is to amend the MSW Landfills I certify that this action will not have disapprove the state plan. If the EPA EG to align the timing requirements in a significant economic impact on a determines that the plan is incomplete, the EG, which were adopted from the substantial number of small entities the EPA would have 2 years to old implementing regulations, with the under the RFA. This action proposes a promulgate a federal plan. Similarly, if timing and completeness checklist technical amendment to the MSW the EPA disapproves a state plan (even requirements in the proposed new Landfills EG promulgated in 2016, one that met the completeness implementing regulations at 40 CFR part which was determined not to impose requirements), the EPA would have 2 60, subpart Ba (see 83 FR 44803 et seq.). any requirements on small entities due years to promulgate a federal plan. The EPA is taking comment on to the fact that emission guidelines However, a state would always be able amending the cross-references in the established under CAA section 111(d) to submit a revised state plan that MSW Landfills EG to refer to the timing do not impose any requirements on corrects the deficiencies, and, and completeness requirements in the regulated entities and, thus, will not depending on the timing, the EPA could proposed new implementing have a significant economic impact either approve that plan before regulations, requiring states that have promulgating a federal plan or, if a 8 The current proposal is separate and distinct federal plan had already been 7 Sources owned or operated by federal, state, from the ongoing reconsideration proceeding promulgated, approve it and withdraw local, and tribal government entities will not be related to the MSW Landfills EG, which is significantly affected by this action because it does scheduled to be proposed in spring 2019. (See the federal plan. not address substantive underlying control https://www.epa.gov/sites/production/files/2017- Although the costs and benefits of requirements. It merely addresses the date by which 05/documents/signed_-_letter_-_municipal_solid_ harmonizing the timing requirements of states must submit plans. waste_landfills.pdf.)

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upon a substantial number of small I. Executive Order 13211: Actions existing municipal solid waste landfills entities. See 81 FR 59309–9310 for Concerning Regulations That that commenced construction, additional discussion. We have, Significantly Affect Energy Supply, modification, or reconstruction on or therefore, concluded that this action Distribution, or Use before July 17, 2014, you must submit similarly will have no net regulatory This action is not a ‘‘significant a state plan to the U.S. Environmental burden for all directly regulated small energy action’’ because it is not likely to Protection Agency (EPA) that entities. have a significant adverse effect on the implements the Emission Guidelines contained in this subpart. The E. Unfunded Mandates Reform Act supply, distribution, or use of energy. requirements for state and federal plans (UMRA) Further, we have concluded that this action is not likely to have any adverse are specified in 40 CFR part 60, subpart This action does not contain any energy effects because it is a procedural B with the exception that §§ 60.23 and unfunded mandate as described in change and does not have any impact on 60.27 will not apply. The following UMRA, 2 U.S.C. 1531–1538, and does energy supply, distribution, or use. requirements apply instead: not significantly or uniquely affect small (1) Notwithstanding the provisions of governments. J. National Technology Transfer and § 60.20a(a) in 40 CFR part 60, subpart The action implements mandate(s) Advancement Act (NTTAA) Ba, the requirements of §§ 60.23a and specifically and explicitly set forth in 40 This rulemaking does not involve 60.27a will apply for state and federal CFR part 60, subpart Ba without the technical standards. plans, except that the requirements of exercise of any policy discretion by the § 60.23a(a)(1) will apply to a notice of EPA. K. Executive Order 12898: Federal availability of a final guideline Actions To Address Environmental F. Executive Order 13132: Federalism document that was published under Justice in Minority Populations and § 60.22(a); and This action does not have federalism Low-Income Populations (2) The requirements of § 60.27a(e)(1) implications. It will not have substantial The EPA believes that this action is will refer to a final guideline document direct effects on the states, on the not subject to Executive Order 12898 (59 that was published under § 60.22(a) and relationship between the national FR 7629, February 16, 1994) because it the requirements of § 60.27a(e)(2) will government and the states, or on the does not establish an environmental refer to § 60.24(f). distribution of power and health or safety standard. This (b) You must submit a state plan to responsibilities among the various regulatory action is a procedural change the EPA by August 29, 2019. levels of government. and the EPA does not anticipate that it * * * * * G. Executive Order 13175: Consultation will have any material impact on human [FR Doc. 2018–23700 Filed 10–29–18; 8:45 am] and Coordination With Indian Tribal health or the environment. BILLING CODE 6560–50–P Governments List of Subjects in 40 CFR Part 60 This action does not have tribal Environmental protection, ENVIRONMENTAL PROTECTION implications, as specified in Executive Administrative practice and procedures, AGENCY Order 13175. The MSW Landfills EG Emission guidelines, Landfills, recognized that one tribe had three Reporting and recordkeeping 40 CFR Part 60, 61, 63, 70 and 72 landfills that may potentially be subject requirements, State plan. to the emission guidelines, but noted [EPA–R08–OAR–2018–0299; FRL–9985–72– that these landfills have already met Dated: October 23, 2018. Region 8] requirements under the previous new Andrew R. Wheeler, Acting Administrator. Proposed Approval of Recodification source performance standards/emission and Revisions to State Air Pollution guidelines framework as promulgated in For the reasons stated in the Control Rules; North Dakota; Proposed 1996 (see 81 FR 59311). However, this preamble, the Environmental Protection Interim Approval of Title V Program action does not have a substantial direct Agency proposes to amend part 60 of Recodification and Revisions; effect on that tribe since it is merely a title 40, chapter I, of the Code of Federal Proposed Approval of Recodification procedural change amending timing Regulations as follows: and Revisions To State Programs and requirements for states to submit plans Delegation of Authority To Implement to the EPA and for the EPA to PART 60—STANDARDS OF PERFORMANCE FOR NEW and Enforce Clean Air Act Section 111 promulgate a federal plan. Thus, and 112 Standards and Requirements Executive Order 13175 does not apply STATIONARY SOURCES to this action. AGENCY: Environmental Protection ■ 1. The authority citation for part 60 Agency (EPA). H. Executive Order 13045: Protection of continues to read as follows: ACTION: Proposed rule. Children From Environmental Health Authority: 42 U.S.C. 7401 et seq. Risks and Safety Risks SUMMARY: The Environmental Protection This action is not subject to Executive Subpart Cf—Emission Guidelines and Agency (EPA or the ‘‘Agency’’) has Order 13045 because it is not Compliance Times for Municipal Solid reviewed changes to the North Dakota economically significant as defined in Waste Landfills Air Pollution Control Rules. Concluding Executive Order 12866, and because the ■ 2. Section 60.30f is amended by review of those changes, the EPA is EPA does not believe the environmental revising paragraphs (a) and (b) to read proposing interim approval of revisions health or safety risks addressed by this as follows: to the North Dakota operating permit action present a disproportionate risk to program for stationary sources subject to children. This regulatory action is a § 60.30f Scope and delegated authorities. title V of the Clean Air Act (CAA or the procedural change and does not have * * * * * ‘‘Act’’) and recodification of the title V any impact on human health or the (a) If you are the Administrator of an program under a new title of the North environment. Thus, it will not air quality program in a state or United Dakota Administrative Code (NDAC). disproportionately affect children. States protectorate with one or more This document also proposes approval

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of North Dakota’s revision and Multimedia submissions (audio, video, required North Dakota to revise the recodification of the State’s programs for etc.) must be accompanied by a written NDAC to codify the NDDEQ’s source of implementing and enforcing delegated comment. The written comment is legal, jurisdictional and enforcement requirements under certain sections of considered the official comment and authority, and to define the programs the Act, and consequentially the means should include discussion of all points and regulations that the NDDEQ will for the Agency’s proposed approval of a you wish to make. The EPA will implement. The creation of the NDDEQ revised delegation arrangement between generally not consider comments or also requires the State to seek EPA the EPA and the State of North Dakota comment contents located outside of the approval for the migration of these for transfer of authority to regulate primary submission (i.e., on the web, authorities and all amendments to sources under those sections. Upon final cloud, or other file sharing system). For related programs and agreements. On approval of this rulemaking action additional submission methods, the full August 6, 2018, North Dakota, having North Dakota will receive delegation of EPA public comment policy, recodified the state environmental authority to implement and enforce information about CBI or multimedia regulations,2 submitted to the Acting CAA section 111 New Source submissions, and general guidance on Administrator a request for approval of Performance Standards (NSPS) and making effective comments, please visit the revision and transfer of the State’s section 112 National Emission http://www2.epa.gov/dockets/ CAA programs as they will be Standards for Hazardous Air Pollutants commenting-epa-dockets. administrated by the NDDEQ. Among (NESHAP), including Maximum Docket: All documents in the docket the duties of the new NDDEQ is the Achievable Control Technology (MACT) are listed in the www.regulations.gov implementation and enforcement of the requirements within the state, excluding index. Although listed in the index, North Dakota Operating Permits Indian country, exactly as the some information is not publicly Program and programs implemented via requirements were promulgated by EPA available, e.g., CBI or other information that program including the Act’s section (i.e., ‘‘straight delegation’’). Straight whose disclosure is restricted by statute. 111 and 112 standards and a program delegation of sections 111 and 112 Certain other material, such as for implementation of Title IV of the authorities does not include those copyrighted material, will be publicly Act, all of which the EPA had authorities reserved by the EPA available only in hard copy. Publicly previously approved and delegated to Administrator or otherwise reserved by available docket materials are available the State in prior rulemaking actions. In the EPA, nor the authority to implement either electronically at these prior actions we determined that and enforce regulations not www.regulations.gov or in hard copy at NDDH met, among other things, the incorporated unchanged into state code, the Air Program, Environmental relevant statutory and regulatory and does not include those regulations Protection Agency (EPA), Region 8, authority and the ability to implement unincorporated by North Dakota and 1595 Wynkoop Street, Denver, Colorado and enforce the operating permits omitted from the State’s request for 80202–1129. The EPA requests that, if at program. delegation. Upon finalization of this all possible, you contact the individual After the EPA receives a program rulemaking, North Dakota will also listed in the FOR FURTHER INFORMATION revision, the Administrator shall continue to be eligible for future CONTACT section to view the hard copy approve or disapprove program automatic delegation of incorporated, of the docket. You may view the hard revisions based on the requirements of unchanged federal requirements, copy of the docket Monday through part 70 and the Act.3 In addition to the without need for request of Agency Friday, 8:00 a.m. to 4:00 p.m., excluding recodifications to the State’s title V approval on a case-by-case basis. The federal holidays. permitting program, the State’s proposed action effects the transfer of FOR FURTHER INFORMATION CONTACT: submittal includes recodifications of the title V program administration and Gregory Lohrke, Air Program, EPA, programs for implementation and delegated authority to implement and Region 8, Mailcode 8P–AR, 1595 enforcement of delegated section 111 enforce sections 111 and 112 Wynkoop Street, Denver, Colorado and 112 standards and requirements. requirements from the North Dakota 80202–1129; (303) 312–6396; The recodification and minor revisions Department of Health (NDDH) to the [email protected]. to North Dakota’s section 111 and 112 newly created North Dakota Department SUPPLEMENTARY INFORMATION: programs also requires the EPA to of Environmental Quality (NDDEQ or I. Background Information determine whether to make minor the ‘‘Department’’). The EPA is taking revisions to the delegation arrangements these actions pursuant to sections 501– The North Dakota Century Code concerning those programs. North 506, 111 and 112 of the Act. (NDCC) currently designates the NDDH Dakota’s rules authorizing the NDDEQ DATES: Written comments must be as the primary state environmental to administer the State’s environmental received on or before November 29, agency (NDCC 23–01). The North programs only become effective after the 2018. Dakota health department’s authority to State receives the necessary federal administer and implement the North approvals.4 North Dakota’s operating ADDRESSES: Submit your comments, Dakota Air Pollution Control Rules is identified by Docket ID No. EPA–R08– codified in NDAC Article 33–15. On 2 For reference here and throughout today’s notice OAR–2018–0299 at http:// April 7, 2017, the Governor of North concerning the renumbering and recodification of www.regulations.gov. Follow the online Dakota signed legislation to amend the NDCC and NDAC provisions relevant to the transfer instructions for submitting comments. NDCC for the creation of the NDDEQ of CAA authorities to the NDDEQ, see the general Once submitted, comments cannot be guidance document, ‘‘Crosswalk on Recodifications and initiate the transfer of all authority, of Relevant NDCC and NDAC Sections,’’ available edited or removed from powers and duties of the NDDH related in the docket for today’s notice. www.regulations.gov. The EPA may to environmental quality to the new 3 40 CFR 70.4(i)(2). publish any comment received to its Department.1 The migration of legal and 4 EPA’s proposed approval actions on North public docket. Do not submit implementation authority, from the Dakota’s submittal to transfer its Title V Program electronically any information you approval and its delegated authority for the NDDH and to the new Department, NESHAP, MACT and NSPS from the North Dakota consider to be Confidential Business Department of Health to the North Dakota Information (CBI) or other information 1 North Dakota Session Laws 2017, Ch. 199. § 1 Department of Environmental Quality does not whose disclosure is restricted by statute. (Senate Bill 2327). Continued

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permit and source requirements become relevant sections of recodified and included in its request for approval of federally enforceable on the effective revised state regulations.6 This revisions to its operating permit date of final approval of this rulemaking submittal was supplemented on August program a description of how the action. 16, 2018, with an Attorney General’s NDDEQ intends to carry out its opinion describing the NDDEQ’s legal responsibilities under part 70 and title II. Summary of North Dakota’s Title V authority to administer and enforce V of the CAA (see criteria for program Program Recodification and Revisions aspects of the operating permit program descriptions at § 70.4(b)(1)). The State’s A. Introduction under part 70 and title V of the Act.7 program description outlines both the Title V of the 1990 CAA amendments North Dakota is not resubmitting the basis for operating permit program directed the EPA to develop and operating permit program, rather the implementation and the organizational promulgate rules that define the State is only updating the numbering of structure of the NDDEQ’s Division of necessary elements of an approvable its operating permits program and Air Quality. The program description state operating permits program and the related amendments that have also includes job classification necessary standards and procedures by previously been approved by the EPA. descriptions for all staff positions which the EPA will approve, oversee, Therefore, except for the minor changes responsible for carrying out the and, when necessary, withdraw to the regulations analyzed in Section operating permits program under the approval of a state’s permitting II.B.4, this notice proposes action on the NDDEQ’s air quality division. authority under such programs. These recodification and amendments as Implementation of the North Dakota operating permit program requirements appropriate and consistent with the title V program will be based on are codified at 40 CFR part 70 (part 70). transfer of authority and change in name implementation authority granted by the Title V also directs states to develop and and does not re-approve the substantive relevant sections of NDAC article 33.1– 8 submit to the EPA approvable programs State regulations. 15, as submitted to the EPA for review. The NDDEQ also provides that it will for the issuance of operating permits to B. Analysis of State Submittal all major stationary sources and to generate guidance and policy The EPA finds the State of North certain other sources within the state’s documents to clarify the bounds and Dakota’s modified operating permits jurisdiction. Part 70 includes the details of this implementation program submittal to be 9 procedure for state requests to the EPA authority. The Department’s administratively complete for requesting for approval of revisions to the state’s organizational structure is explained approval of recodification and revisions operating permit program (§ 70.4(i)), and within the submittal in both narrative to the State’s program and the transfer 10 for EPA approvals of partial or complete and graphical form. The Division is of all authorities related to the transferal of permitting authority from equivalent in form and substance to, permitting program to the newly created one state agency to another (§ 70.4(i)(2)). and entirely replaces, the North Dakota received interim NDDEQ. This determination was made Environmental Section of the NDDH, approval of its operating permit program with reference to the criteria for which the EPA previously approved (64 effective on August 7, 1995 (60 FR administrative completeness found in FR 32433). The State has historically 35335). The State later received final, 40 CFR part 70. An accounting of also demonstrated adequate resources full approval effective on August 16, specific, required submittal elements for and capabilities for implementation and 1999 (64 FR 32433). On August 6, 2018, revisions to state operating permit enforcement of the State title V program, the State of North Dakota submitted to programs and transfers of authority to and identified no new divisions of the EPA a formal request for approval of new state agencies are in 40 CFR relevant authorities created by the all operating permit program 70.4(i)(2). This section specifies the transfer of powers to the NDDEQ recodifications and revisions, for submittal requirements for any state- (§ 70.4(i)(2)). Therefore, we propose to transferal of permitting authority to the initiated program revision as being: (1) approve the program description NDDEQ, along with requests for A modified program description; (2) an information as appropriate and approvals of delegations of authority for Attorney General’s statement; and (3) consistent with the transfer of authority. such other documents as EPA other related programs under the Act 2. Attorney General’s Statement (See sections III and IV of this notice).5 determines to be necessary The submittal included a modified (70.4(i)(2)(i)). Additional evaluation Title 40 CFR 70.4(b)(3) enumerates program description, documentation of criteria specific to initial program the necessary elements of the Attorney rulemaking procedures followed, submittals, used as supplemental General’s statement required for including public comment criteria in the EPA’s review of the program revisions covered by documentation, and copies of the necessary submittal elements, are found § 70.4(i)(2)(i). These elements are under § 70.4(b). necessary to ensure that the State operating permit authority receiving extend to Indian country as defined in 18 U.S.C. 1. Program Description 1151. Indian country generally includes (1) lands transfer of the title V program has the within the exterior boundaries of the following As required under 40 CFR complete legal authority to carry out the Indian reservations located within North Dakota: 70.4(i)(2)(i), the State of North Dakota requirements of a part 70 program. This The Fort Berthold Indian Reservation, the Spirit includes, but is not limited to, the Lake Reservation, the Standing Rock Sioux 6 For purposes of cross-referencing a recodified authority to: Issue permits and assure Reservation, and the Turtle Mountain Reservation; provision of the NDAC air pollution control rules (2) any land held in trust by the United States for with its previous version, we note that the source compliance with each applicable an Indian tribe; and (3) any other areas that are recodification followed a consistent scheme: All requirement and requirement of part 70; ‘‘Indian country’’ within the meaning of 18 U.S.C. rules previously codified as 33–15–xx–xx are now incorporate monitoring, recordkeeping, 1151. The EPA, or eligible Indian tribes, as codified as 33.1–15–xx–xx. For example: All Title reporting and compliance certification appropriate, will retain responsibilities under CAA V Permit to Operate provisions previously codified Sections 501–506, 111, and 112 for air quality in under NDAC section 33–15–14–06 are now codified Indian country. at corresponding subsections of NDAC section 8 See submittal package document, ‘‘Title V 5 The submittal package, ‘‘Title V Permit to 33.1–15–14–06. Permit to Operate, MACT, NESHAPs and NSPS Operate, MACT, NESHAPs and NSPS Programs for 7 The Attorney General’s statement, ‘‘Attorney Programs for Department of Environmental Quality, Department of Environmental Quality, Division of General’s Opinion Operating Permits Program,’’ is Division of Air Quality’’ at section 1.A. Air Quality,’’ is available for public review in the available for public review in the docket for today’s 9 Ibid. docket for today’s notice. notice. 10 Ibid. at sections 1.B and 1.C.

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requirements into permits; incorporate than 30 days after the new grounds for amendments to NDAC section 33–15– into permits all applicable requirements review arise.12 14–06 to bring its regulations into and part 70 requirements; terminate, The statement concludes by alignment with the federal part 70 modify, or revoke and reissue permits explaining that ‘‘an addendum to the operating permit program requirements for cause; enforce permits, permit fee opinion will be submitted once these as amended between 1999 and the requirements, and the requirement to rules are adopted.’’ Therefore, while present.13 The EPA proposes to approve obtain a permit; make available to the State law grants the Department the State’s previously unconsidered public any permit application contents: authority to grant petitioners the right to program amendments as listed below for Compliance plan, permit, and some opportunities for judicial review, the following reasons: monitoring and compliance certification Department rules limit the full authority • Under subsection 1 (‘‘Definitions’’), report; not issue a permit if the required under 40 CFR 70.4(b)(3)(x)– three paragraphs were added to reflect Administrator objects to its issuance in (xii) (NDCC §§ 23.1–01–11, 23.1–06– the EPA’s amendments to 40 CFR 70.2. a timely manner or, if the permit has not 04(1)(l), 28–32–42; NDAC § 33.1–15–14– Two paragraphs add new definitions for already been issued, to public petitions 06(8)). The EPA proposes to find that ‘‘Approved replicable methodology to the EPA; and insure the opportunity the Attorney General’s statement is (ARM)’’ 14 and ‘‘Alternative operating for judicial review of permit actions appropriate and consistent with the scenario (AOS),’’ 15 in accordance with under the conditions outlined in part 70 transfer of authority, except for the the EPA’s 2009 revisions to the part 70 (40 CFR 70.4(b)(3)(i)–(xiii)). limitations on judicial review under regulations (74 FR 51417). The third North Dakota’s Attorney General’s title V and § 70.4(b)(3)(x)–(xii) described paragraph was added to account for the statement provides descriptions of the in the Attorney General’s opinion. The EPA’s 2010 addition of a definition for legal authority under the recodified effects of these limitations on the EPA’s ‘‘Subject to regulation’’ 16 to § 70.2 (75 laws and regulations of the State to proposed action are discussed in section FR 31513). The State made conforming carry out all aspects of an operating II.C of this document. amendments to its Definitions to permits program, including the 3. Supporting Documents incorporate these additions (e.g., when authority to carry out each of these the new definition for AOS was added, 11 The transfer of permitting program preceding elements. The statement by inserting 33–15–14–06.1.d, with all includes citations to the relevant State authorities to the newly created Department will be accompanied by a of the subsequent definitions amended laws and regulations that grant these to maintain alphabetical order: 33–15– authorities, that provide the transfer of all related program operations as they have existed under 14–06.1.d became 33–15–14–06.1.e, and corresponding requirements of the Act so forth). North Dakota has also and federal regulations of part 70. the authority of the NDDH. Since the North Dakota title V program is amended the definition of ‘‘Major During North Dakota’s review of the source’’ under this subsection to reflect NDAC for recodification and submittal reasonably assumed to operate in the future as it has since full program the exact 2001 EPA revisions to the to the EPA, the State discovered major source definition under 40 CFR limitations on the opportunity for approval in 1999, the EPA asked for no additional supporting documents, such 70.2 (66 FR 59161); judicial review in State courts. The EPA • regulation for state operating permit as would be required for initial program Under subsection 4 (‘‘Permit programs outlines the conditions and submittals under 40 CFR 70.4(b)(4)–(16), applications’’), several paragraphs, requirements for granting affected except for the relevant NDCC and NDAC along with specific language, were parties the opportunity to appeal for sections as revised and recodified for removed relating to the timeline for judicial review in state courts (40 CFR program transfer. With the exception to initial title V permit applications, which 70.4(b)(3)(x)–(xii)). The Attorney the revisions needed to the regulations the State explains no longer apply to General’s opinion explains that while discussed in section II.B.4 of this notice, any source in North Dakota and are no State law provides for opportunity for we propose to find that the recodified longer necessary. Two paragraphs were judicial review for most of the regulations are substantively equal to added to specify requirements for a requirements in 40 CFR 70.4(b)(3)(x)– those the EPA previously approved for description and compliance schedule (xii), the provisions are overly limited. implementation and enforcement of the for source requirements associated with The opinion explains that the State State’s operating permit program, the a proposed AOS, to be included in the intends to revise its rules to remedy the structure and operations of the compliance plan for all title V sources limitations on judicial review: implementing authority can be assured submitting operating permit to continue in a similar, adequate applications (paragraphs 4.c.(8)(b)[4] Forthcoming Department rules will manner as they did under the NDDH, and (c)[4]). The State made these provide that if the final permit action being and the relevant NDCC and NDAC challenged is the Department’s failure to take additions, as well as limited revisions to final action, a petition for judicial review sections are appropriate and consistent various paragraphs (33–15–14–06.4.c(2), may be filed at any time before the with the transfer of authority. (3)(c) and (7)) under this subsection,17 to Department denies the permit or issues the 4. Analysis of the State’s Prior final permit; and that where petitions for 13 Unapproved Amendments to NDAC 33– For the purposes of cross-referencing pre- judicial review are based solely on grounds submittal revisions to NDAC 33–15–14–06 (title V arising after the 30-day deadline for judicial 15–14–06 program) with the recodification of those revisions review, such petitions may be filed no later Since the full approval of North under NDAC 33.1–15–14–06, and a comparison of how these revisions reflect the EPA’s amendment Dakota’s title V operating permit of 40 CFR part 70 during the years between initial, 11 For purposes of representing the necessary program in 1999 (64 FR 32433), the full approval of North Dakota’s title V program and elements of an acceptable Attorney General’s the present, please see the document, ‘‘Post-1999 opinion (§ 70.4(b)(3)(i)–(xiii)), and how the State has made several minor changes to Amendments to North Dakota Title V Program,’’ in submitted Opinion presents those elements and the section of North Dakota regulations the docket for today’s notice. demonstrates the State’s legal authority through the that provide the legal authority to 14 NDAC 33.1–15–14–06.1.f. recodified, relevant sections of its NDCC and implement and enforce such a program. NDAC, please reference the documents, ‘‘Attorney 15 33.1–15–14–06.1.d. General’s Opinion Operating Permits Program,’’ North Dakota made most of these 16 33.1–15–14–06.1.cc. and, ‘‘AG Opinion Review,’’ found in the docket for 17 Docket item: ‘‘Post-1999 Amendments to North today’s notice. 12 Ibid. Dakota Title V Program.’’

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accommodate permit applications from North Dakota’s revised title V program 72.’’ 21 NDCC 23.1–06–04(1)(l); NDAC sources with an AOS after the EPA’s submittal includes all amendments to 33.1–15–21. Additionally, North 2009 revisions to part 70 regulations (74 NDAC section 33–15–14–06 as they Dakota’s revised title V program FR 51417). The limited revisions to have been incorporated into the submittal demonstrates adequate legal these three paragraphs were made to recodification of North Dakota’s title V and regulatory authority to issue reflect the changed language of their permitting regulations at NDAC 33.1– permits that reflect the requirements of federal regulation corollaries (40 CFR 15–14–06. These amendments were title IV of the Act.22 North Dakota will 70.5(c)(2), (3)(iii) and (7)) after the 2009 made to either directly reflect the EPA’s continue to implement an acid rain CFR revisions; amendments to the federal part 70 program through the NDDEQ • Under subsection 5 (‘‘Permit regulations during the years since North substantively equal to the program content’’), North Dakota revised the Dakota’s full program approval (64 FR approved with the original interim title language of paragraphs a.(1) and a.(9) to 32433) or as North Dakota-specific V program approval (See 60 FR 20945). account for the EPA’s revisions to amendments. All of the State’s Because of the substantively equal various part 70 requirements attendant amendments, except for those to NDAC authorities and capabilities of the NDDH to the addition of definitions for ARM subsection 33–15–14–06.8 and its and the NDDEQ, North Dakota has and AOS. These changes were made in successor, the limitations of which are reasonably assured the EPA of its ability accordance with the EPA’s 2009 discussed in section II.B.2 of today’s to meet the requirements related to title revisions to part 70 regulations (74 FR notice, are found to be approvable. IV of the Act, through the issuance and 51417). These two paragraphs Many of these changes were made to enforcement of title V operating permits. incorporate paragraphs 40 CFR bring state regulations into accord with Therefore, we propose to approve the 70.6(a)(1) and (a)(9), as revised in 2009 the EPA’s changes to part 70 transfer of the acid rain program as with minor terminology changes to requirements over that time period. The appropriate and consistent with the accommodate reference to the North remaining changes to NDAC 33–15–14– transfer of authority. Dakota Program instead of a generalized 06 were not in response to modified C. Proposed Action state program. The State also revised federal regulations; however, the State’s language under paragraph c.(5)(c)[2] of changes do not create an operating North Dakota’s program meets the this subsection to clarify and update permits program any less stringent than minimum requirements and otherwise compliance certification requirements substantially meets the part 70 is required under 40 CFR part 70. We 23 in accordance with the EPA’s 2014 propose to find that all previously requirements, but is not fully approvable because as described in revisions to section 70.6 (79 FR 43661). unapproved amendments to the North section II.B.2 the Attorney General This paragraph incorporates 40 CFR Dakota Program between full approval Opinion explains that the State’s rules 70.6(c)(5)(iii)(B), as revised in 2014 with and the transfer of authority to the lack full authority required for judicial minor terminology changes to NDDEQ, as they have been recodified review.24 Therefore, the EPA proposes accommodate reference to the North under NDAC 33.1–15–14–06, are interim approval of the State’s operating Dakota Program and the State’s air approvable for the purposes of part 70 permit program under 40 CFR 70.4(d) quality control rules instead of a program implementation and and CAA section 502(g). An interim generalized state program and the CFR; enforcement. • Under subsection 8 (‘‘Judicial approval of North Dakota’s operating review of title V permit to operate 5. Transfer of the Acid Rain Program permit program would solely be to decisions’’), the State added the allow the State to make minor revisions North Dakota’s request for transfer of subsection by adding paragraphs 8.a to NDAC 33.1–15–14–06.8, and update the title V operating permit program through 8.e to codify most of the legal the Attorney General’s opinion to reflect authority to provide judicial review of includes the request to transfer revised legal authorities, as a precursor permit decisions as required of state associated State responsibilities for the to full approval of the State’s operating CAA title IV Acid Rain Program (40 CFR permit program (See discussion in operating permit programs and 19 described under section 70.4(b)(3)(x)– parts 72, 75 and 76). 40 CFR section II.B.2 of this notice). The EPA (xii); and 70.4(b)(3)(xiii) specifies that the will act as expeditiously as possible to • Under subsection 10 (‘‘Compliance attorney general’s legal opinion ensure finalize full approval of North Dakota’s assurance monitoring’’), North Dakota that the authority of the state permitting title V program once the revised State incorporated by reference the agency is not used to modify the acid rules and Attorney General’s opinion compliance assurance monitoring rain program requirements. The EPA are submitted to the EPA. Proposed (CAM) regulations of 40 CFR part 64 issued guidance to clarify the primary interim approval shall not be construed with minor revisions to three definitions criteria for approval of state submittals as approving any deviation from the used in part 64 to insure the State’s to carry out the acid rain portion of the implementation and enforcement 20 delegated implementation and operating permits program. The requirements under part 70 or as an enforcement authority regarding those Attorney General opinion assures that approval of a program less stringent regulations. ‘‘State law is consistent with, and than that described by part 70 • Additionally, the EPA promulgated cannot be used to modify, the Acid Rain requirements. Under section 70.4(d) the amendments to the part 70 regulations Program requirements of 40 CFR part EPA proposes to set an expiration date that North Dakota has not adopted and for interim approval, not to exceed 2 the EPA proposes to find that is was not 19 Title V Permit to Operate, MACT, NESHAPs years after such an approval and non- necessary for the State to adopt these and NSPS Programs for Department of Environmental Quality, Division of Air Quality; see 18 amendments. Governor’s letter and section 1.B. 21 Attorney General’s Opinion Operating Permit 20 EPA Memorandum, ‘‘Title IV-Title V Interface Program, August 16, 2018, p. 9. 18 A table of these EPA 40 CFR part 70 revisions Guidance for States,’’ from Lydia Wegman, Deputy 22 Ibid., and throughout. and justification for North Dakota, not including the Director, Office of Air Quality Planning and 23 40 CFR 70.4(d)(3). revisions in the State’s operating permits program, Standards and Paul Stolpmann, Acting Director, 24 As explained in the Attorney General’s may be found in the document, ‘‘EPA Amendments Office of Atmospheric Programs, to EPA Air Opinion, forthcoming State rules will remedy this to Part 70 Not Adopted,’’ included in the docket for Division Directors, included in the docket for limitation and an addendum to the opinion will be this action. today’s notice. submitted once the rules are adopted.

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renewable upon expiration. If the EPA implement and enforce future section and disclosure of information; (8) finalizes an interim approval of North 112 standards and requirements without resources; and (9) reporting to EPA.28 29 Dakota’s title V program, the interim case-by-case approval, so long as the B. Analysis of State Submittal approval’s expiration date will be set for standards and requirements are no later than January 1, 2021. incorporated unchanged into state code. Referring to a state’s title V program North Dakota was operating under an final approval would normally satisfy III. Delegation of NESHAP and MACT the common approval criteria set forth Requirements automatic delegation arrangement prior to recodification of the State’s section for straight delegation of section 112 A. Introduction 112 program and the planned transfer of authorities to the state (40 CFR 63.91(d)(3)). However, North Dakota’s Section 112 of the CAA authorizes the authority to implement and enforce title V program also underwent EPA to develop and periodically revise state environmental regulations from the 27 recodification during the proposed a list of all categories and subcategories NDDH to the NDDEQ. transfer of authority to the NDDEQ and of major sources and area sources of The NDDH’s planned transfer of was revised since EPA’s final approval. hazardous air pollutants (HAP). To authorities pursuant to State law to a Notice of proposed rulemaking action reduce HAP emissions from these new State agency required minor on the recodifications and revisions to sources, this section of the Act also revisions and the recodification of State North Dakota’s title V program is found authorizes the EPA to promulgate rules and its section 112 program for in Section II of today’s proposed federally enforceable NESHAP and implementation and enforcement of rulemaking document. Due to the MACT requirements for source NESHAP and MACT requirements. The concurrent nature of the title V revisions categories. The NESHAP and MACT recodification of the State’s program and recodifications and section 112 requirements are promulgated in parts requires the State provide the Agency program recodifications and of the 61 and 63 of title 40 of the CFR. Section with a copy of the revised authorities EPA’s simultaneous review of those 112(l) of the Act provides a mechanism and a formal request for approval revisions, the EPA evaluates the section for approval of programs and delegation measured against the criteria for 112 program recodifications against the of authority to the states to implement approval found under 40 CFR 63.91(d) and enforce these federal standards and and any additional relevant approval criteria for stand-alone up-front requirements. A state’s program may criteria in 40 CFR part 63, subpart E. completeness and approvability. The North Dakota request for section provide for partial or complete In a letter dated August 6, 2018, North 112 program approval was measured for delegation of the Agency’s authorities Dakota submitted to the EPA final completeness against all up-front and responsibilities to implement and revisions to the State’s Air Pollution approval criteria found under 40 CFR enforce section 112 standards and Control Rules pertaining to 63.91(d). These criteria as they were requirements, so long as those administration, implementation and fulfilled by the State of North Dakota authorities are carried out by an enforcement of CAA section 112 are: (1) A written finding by the State approvable state program with emissions standards and requirements standards and requirements no less Attorney General that the NDDEQ has by the new NDDEQ. This letter included the necessary legal authority to stringent than those promulgated by the a request to approve straight delegation EPA. The regulations found in 40 CFR implement and enforce the State’s rules of all NESHAP and MACT requirements and source requirements upon program part 63, subpart E establish procedures incorporated unchanged into the consistent with section 112(l) for the approval and to assure compliance by recodified State regulations, and a all sources within the State of North approval of state rules, programs, or submittal package justifying the other requirements, as well as Dakota with each applicable section 112 approvability of the State’s revised standard or requirement procedures for the delegation of section 112 program. The EPA reviewed (§ 63.91(d)(3)(i)); 30 (2) a copy of all authority to states to implement and the State’s program and recodified NDCC and NDAC statutes and enforce all section 112 federal rules as incorporations of federal requirements regulations relevant to the promulgated, without changes, after (NDAC chapters 33.1–15–12 and 33.1– implementation and enforcement by the their incorporation into state code (40 15–22) for equivalency to the formerly NDDEQ of section 112 standards and CFR 63.91). approved implementation and requirements upon final program North Dakota first received straight enforcement program and former approval (§ 63.91(d)(3)(ii)); 31 (3) a delegation of authority to implement codification of federal requirements narrative and graphical description of and enforce NESHAP and MACT (NDAC chapters 33–15–12 and 33–15– the NDDEQ, the agency’s organization requirements on July 7, 1995 (60 FR 22). The EPA also evaluated the and the adequacy of its institutional 35335) upon the parallel interim submittal for approvability on the approvals of the State’s section 112 program’s own merits as measured 28 For reference, this document may be found in implementation and enforcement plan against the approval criteria found in and the State’s title V program.25 The the docket for today’s notice. subpart E of 40 CFR part 63. 29 For a detailed demonstration of North Dakota’s EPA subsequently informed North Additionally, we evaluated North program adequacy following the program elements Dakota of the procedures for NESHAP Dakota’s request for section 112 program in the EPA’s 1983 ‘‘Good Practices Manual for and MACT automatic delegation.26 An Delegation of NSPS and NESHAPs,’’ see the approval based on the nine elements in NESHAP and MACT Program Descriptions, automatic delegation arrangement with the EPA’s 1983 ‘‘Good Practices Manual a state allows for prospective approval included in the submittal document, ‘‘Title V for Delegation of NSPS and NESHAPs’’: Permit to Operate, MACT, NESHAPs and NSPS of all delegations of authority to (1) Emission limits consistent with Programs for Department of Environmental Quality, Division of Air Quality,’’ please refer to section 2– Federal regulations; (2) test methods 25 Appendix A to 40 CFR part 70. North Dakota 3 (PDF pages 32–39), found in the docket for today’s (b). consistent with federal regulations; (3) notice. 26 See letter addressed to Director Jeff Burgess, reporting and monitoring requirements; 30 See submittal package document, ‘‘Attorney Division of Environmental Engineering, North (4) enforcement; (5) waiver procedures; General’s Opinion.’’ Dakota Department of Health from Director Richard (6) surveillance; (7) public notification 31 See submittal package document, ‘‘Title V R. Long, EPA Region 8 Air and Radiation Program, Permit to Operate, MACT, NESHAPs and NSPS May 16, 2000, ‘‘Delegation Procedures for Section Programs for Department of Environmental Quality, 112 Requirements,’’ in the docket for today’s notice. 27 Ibid. Division of Air Quality’’ at sections 6 and 7.

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resources to implement and enforce all program, just as the NDDH had before The NDDEQ would maintain primary aspects of the section 112 program upon these recodifications. responsibility for the enforcement of the approval (§ 63.91(d)(3)(iii)); 32 (4) a 3. Pursuant the requirement of delegated section 112 standards within schedule demonstrating immediate § 63.91(d)(3)(iii) that the State show the State. If the NDDEQ determines that implementation of the section 112 adequate resources to implement and such enforcement is not feasible and so program upon final approval enforce all aspects of a section 112 notifies the EPA, or on the occasion of (§ 63.91(d)(3)(iv)); and, (5) a plan for program, the State notes in its submittal the NDDEQ acting in a manner expeditious compliance by all affected that the NDDEQ will be funded and incongruous with the terms of this sources subject to the NDDEQ section staffed at the same level as the delegation arrangement, the EPA may 112 program upon final approval Environmental Health Division of the exercise its parallel enforcement (§ 63.91(d)(3)(v)). NDDH which previously carried out all authority pursuant section 113 of the North Dakota provides the required aspects of the section 112 program.35 CAA with respect to sources within items of 40 CFR 63.91(d)(3), and so 4. Pursuant to the requirements of North Dakota subject to the section 112 fulfills the section 112 program §§ 63.91(d)(3)(iv) and (v), which require hazardous air pollutant standards. submittal criteria set out by that section a demonstration of planned expeditious Additionally, some portions of the and the EPA’s 1983 Manual, as outlined implementation and enforcement of the NESHAP/MACT standards and the below. section 112 program, the State’s associated general provisions may not 1. With respect to the State’s legal submittal quotes a specific provision of be delegated to a state. The EPA retains authority to implement and enforce a Senate Bill 2327 that specifies that all authority over those portions of the section 112 program in the manner ‘‘orders, determinations, and permits’’ section 112 standards and associated required under § 63.91(d)(3)(i): Sections made by the NDDH before the transfer general provisions which may not be VI, VII, XIV and XXII of the Attorney of authority remain in effect. The delegated. In general, the EPA will General’s Opinion provides reference to NESHAPs and MACT Program delegate to a state the authority to make the statutory source of the State’s Descriptions provide additional details decisions which are not likely to be implementation and enforcement regarding program implementation. As nationally significant or to alter the authority for administering a section there will be a continuity in the orders, stringency of the underlying standard. 112 program.33 As the transfer of determinations and permit conditions Pursuant to this goal, the EPA has authorities from the NDDH to the that compose the section 112 program, codified those part 63 general NDDEQ is almost exclusively a there is no further need for provisions which may, and may not, be recodification of state laws and implementation schedules or delegated to a state in 40 CFR 63.91(g). regulations, the EPA also refers to its compliance plans as would be needed The EPA’s complete reasoning for previous determination that these legal in an initial program approval. Pursuant defining those provisions which are and authorities are adequate to carry out a to the EPA’s 1983 Best Practices Manual are not delegable may be found in EPA’s section 112 program to determine that program element for reporting to the July 10, 1998 memorandum 38 or in the this legal authority is maintained by the EPA, the NESHAP and MACT Program related Federal Register notice from NDDEQ. Descriptions explain that the DEQ will January 12, 1999 (64 FR 1880). In 2. Pursuant the requirement of report to the EPA as required by the addition, some portions of the section § 63.91(d)(3)(ii) that the submittal Performance Partnership Agreement 112 requirements, by their own terms, include a copy of all statutes, (PPA) 36 and Appendix A to part 61 may not be delegated to a state. The EPA regulations, and requirements (incorporated by reference in NDAC Administrator retains authority of those containing the appropriate provisions 33.1–15–13). The State’s Descriptions sections of individual subparts that granting the authority to implement and further explain that the DEQ will work require: (1) Approving equivalency enforce the state’s section 112 program, with the EPA to provide information on determinations and alternate test including the related requirements in NESHAP and MACT sources that is methods; (2) decision-making to ensure the EPA’s 1983 Good Practices Manual requested by the EPA. national consistency; and (3) EPA (program elements 1–7) 34 the State has rulemaking in order to implement. The included such a copy of all relevant, C. What NESHAPs are we proposing to document titled ‘‘Delegation of CAA recodified statutes and regulations. As delegate? Authorities Overview’’ in the docket for there were no substantive modifications North Dakota’s request included this proposal provides a list of example to these authorizing statutes and NESHAP in 40 CFR part 61 as they sections in 40 CFR parts 61 and 63 that regulations, the EPA refers to its existed on July 2, 2010, and in 40 CFR may not be delegated. Additionally, this previous determination in the 1995 title part 63 as they existed through July 1, action does not propose delegation of V interim program approval that the 2015.37 This proposed delegation affects any authority under section 112(r), the NDDEQ has adequate authority to only the implementation and accidental release program. implement and enforce a section 112 enforcement authority for those Accordingly, the EPA is retaining standards which had been previously authority over those portions of the 32 Ibid. at sections 2, 3 and 5. delegated to the State under the section 112 requirements that cannot be 33 The NESHAP and MACT Program Descriptions delegated. in the submittal package document, ‘‘Title V Permit previously approved program, and to Operate, MACT, NESHAPs and NSPS Programs which have now been incorporated If this delegation is finalized, all for Department of Environmental Quality, Division unchanged into the State’s revised air questions concerning implementation of Air Quality,’’ Sections 2 and 3 include pollution control rules. and enforcement of the excluded information that meets several program elements in the EPA’s 1983 Best Practices Manual, including, standards in the State of North Dakota program elements 1, 2, 3, 4, 5, and 7. 35 See submittal package document, ‘‘Title V 34 See the NESHAP and MACT Program Permit to Operate, MACT, NESHAPs and NSPS 38 Memorandum from John S. Seitz, Director, Descriptions in the submittal package document, Programs for Department of Environmental Quality, Office of Air Quality Planning and Standards, ‘‘Title V Permit to Operate, MACT, NESHAPs and Division of Air Quality’’ at sections 1, 2, 3, and 5. ‘‘Delegation of 40 CFR part 63 General Provisions NSPS Programs for Department of Environmental 36 See document titled, ‘‘ND PPA 2018–2019,’’ in Authorities to State and Local Air Pollution Control Quality, Division of Air Quality,’’ Sections 1, 2 and the docket for today’s notice. Agencies,’’ available online at: (https:// 3. 37 See NDAC 33.1–15–13–01.1; 33.1–15–22–01. www3.epa.gov/airtoxics/112(l)/delauth9.pdf).

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should be directed to the EPA Region 8 Specific Test Plans; § 63.7(e)(2)(i), must continue to submit all appropriate Office. Approval of Minor Alternatives to Test information to the EPA. Methods; § 63.7(e)(2)(ii) and (f), D. How will statutory and regulatory I. How will unchanged authorities be Approval of Intermediate Alternatives to interpretations be made? delegated to the State in the future? Test Methods; § 63.7(e)(iii), Approval of If this NESHAP delegation is Shorter Sampling Times and Volumes As stated in previous NESHAP finalized, the State will obtain When Necessitated by Process Variables delegation actions, the EPA has concurrence from the EPA on any or Other Factors; § 63.7(e)(2)(iv), (h)(2) approved North Dakota’s mechanism of matter involving the interpretation of and (3), Waiver of Performance Testing; incorporation by reference of NESHAP section 112 of the CAA or 40 CFR parts § 63.8(c)(1) and (e)(1), Approval of Site- standards into the State regulations, as 61 and 63 to the extent that Specific Performance Evaluation they apply to both part 70 and non-part implementation or enforcement of these (Monitoring) Test Plans; § 63.8(f), 70 sources. See, e.g., the EPA’s 2000 provisions have not been covered by Approval of Minor Alternatives to memo to Director Jeff Burgess, Division prior EPA determinations or guidance. Monitoring; § 63.8(f), Approval of of Environmental Engineering, NDDH. All future section 112 requirements E. What authority does the EPA have? Intermediate Alternatives to Monitoring; § 63.9 and 63.10, Approval of incorporated by reference (IBR) into the The EPA retains the right, as provided Adjustments to Time Periods for State rules will become effective on the by CAA section 112(l)(7) and 40 CFR Submitting Reports; § 63.10(f), Approval date the requirement goes into effect 63.90(d)(2), to enforce any applicable of Minor Alternatives to Recordkeeping according to the State’s updated rules emission standard or requirement under and Reporting; and § 63.7(a)(4), and regulations. In the case of future section 112. In addition, the EPA may Extension of Performance Test Deadline. adoption of section 112 requirements, enforce any federally approved state the EPA requests that North Dakota send rule, requirement, or program under 40 G. What is the EPA’s oversight role? notice of the its intention to receive CFR 63.90(e) and 63.91(c)(1)(i). The EPA The EPA oversees a state’s decisions delegation of the requirements within also has the authority to make certain 60 days of the State’s incorporation of to ensure the delegated authorities are decisions under the General Provisions those requirements into the State’s rules being adequately implemented and (subpart A) of parts 61 and 63. In and regulations. The notification should enforced. We will integrate oversight of addition, the EPA may review and include an official copy of the the delegated authorities into the disapprove state determinations and regulation stamped, dated and signed by existing mechanisms and resources for subsequently require corrections. See 40 the appropriate official, with the date of oversight currently in place. If, during CFR 63.91(g)(1)(ii). The EPA also has adoption and the effective date in North oversight, we determine that the State the authority to review a state’s Dakota. Within 30 days of receipt of made decisions that decreased the implementation and enforcement of North Dakota’s notification, the EPA stringency of the delegated standards, approved rules or programs and to will reply with an acknowledgment of withdraw approval if we find then the State shall be required to take the delegation and will change the inadequate implementation or corrective actions and the source(s) relevant Region 8 electronic delegations enforcement. See 40 CFR 63.96. affected by the decisions will be of authority table (found under the Furthermore, the Agency retains any notified, as required by 40 CFR ‘‘Delegations of Authority’’ link at: authority in an individual emission 63.91(g)(1)(ii) and (b). We will initiate http://www2.epa.gov/region8/air- standard that may not be delegated withdrawal of the program or rule if the program) to reflect the new delegation according to provisions of the standard. corrective actions taken are insufficient. of authority. If there is a change in the effective date for the section 112 F. What information must the State H. Should sources submit notices to the requirement, North Dakota must notify provide to the EPA? EPA or the State? the EPA as soon as possible. If the delay In addition to the information For the delegated NESHAP standards extends beyond the section 112 identified in the Performance and authorities covered by this requirement compliance date, the EPA Partnership Agreement, the State must proposed action, if finalized, sources will implement and enforce the provide any additional compliance would submit all of the information requirement until North Dakota has related information to the EPA Region 8 required pursuant to the general fully incorporated the requirement and Air Program within 45 days of a request provisions and the relevant subpart(s) of the final effective date has passed. under 40 CFR 63.96(a). In receiving the delegated NESHAP (40 CFR parts 61 The State also has the option of delegation for specific General and 63) directly to the State. The State receiving partial delegation of a section Provisions authorities, the State must is the primary point of contact with 112 requirement, and the option to submit to the EPA Region 8 on a semi- respect to delegated NESHAPs. Sources cancel the delegation of authority to annual basis, copies of determinations do not need to send a copy to the EPA. implement and enforce previously issued under these authorities. See 40 The EPA Region 8 proposes to waive the adopted requirements. Automatic CFR 63.91(g)(1)(ii). For part 63 requirement that notifications and partial delegation of severable portions standards, these determinations include: reports for delegated standards be of any standard requires that the state: § 63.1, Applicability Determinations; submitted to the EPA in addition to the (1) Clearly define the separable § 63.6(e), Operation and Maintenance State in accordance with 40 CFR subcategory in the particular standard, Requirements—Responsibility for 63.9(a)(4)(ii) and 63.10(a)(4)(ii).39 For or the specific separable subset of Determining Compliance; § 63.6(f), those standards and authorities not affected sources in the specific standard Compliance with Non-Opacity delegated as discussed above, sources so that regulated sources and the public Standards—Responsibility for know who is the implementing and Determining Compliance; § 63.6(h), 39 This waiver only extends to the submission of enforcing authority; and (2) the Compliance with Opacity and Visible copies of notifications and reports; the EPA does applicable portions of the federal not waive the requirements in delegated standards Emissions Standards—Responsibility that require notifications and reports be submitted standard must be adopted by IBR into for Determining Compliance; to an electronic database (e.g., 40 CFR part 63, the state regulations or rules with an § 63.7(c)(2)(i) and (d), Approval of Site- subpart HHHHHHH). additional, clear explanation of what

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portions of the standard are not program and that the part 60 federal notification and information disclosure; included in the standard’s adoption into NSPS requirements are IBR in the state’s (8) adequate program resources; and (9) the State rule. If the State does not want code. If these two program features can a communication protocol between a to use automatic delegation for any of its be positively verified, the state is state and the EPA. North Dakota has previously adopted section 112 considered capable of implementing included in its request for section 111 requirements, then the State may and enforcing the section 111 standards program approval a NSPS program provide a list of those requirements and the state may request delegation of description that seeks to demonstrate which have been adopted and which the authority to administer the NSPS adequacy of the program with respect to State wants to exclude from the requirements for sources within the each of the nine key program elements state. After section 111 program delegation process to the EPA. listed in this paragraph. approval, a state and the EPA may reach J. Proposed Action an agreement to ‘‘automatically’’ B. Analysis of State Submittal The EPA proposes to approve North delegate future NSPS requirements to Dakota’s program for receiving the state, if the future requirements are The EPA reviewed North Dakota’s delegated authority to implement and IBR in the state’s code. Automatic section 111 program adequacy enforce emissions standards and other delegation arrangements allow the state demonstration with reference to the requirements for air pollutants subject to administer the NSPS as they are ‘‘Good Practices’’ manual for NSPS to section 112 of the CAA as recodified updated or introduced without need for delegations. The requirements of by the State. The EPA also proposes case-by-case approvals from the EPA. emission limits and test methods approval of revisions to the section 112 North Dakota and the EPA currently consistent with federal regulations, as automatic delegation arrangement maintain such an arrangement. well as the requirement of adequate between the EPA and the State of North The EPA last affirmed delegation of source reporting and monitoring Dakota to accommodate the transfer of NSPS to North Dakota in a letter dated requirements, have been met with the environmental regulatory programs from February 27, 2014,40 which was IBR of federal NSPS requirements in the the NDDH to the NDDEQ. The proposed subsequently published for public State air pollution control rules. The approval of recodification of federal notice in the Federal Register on State updated all IBR citations as NESHAP and MACT requirements and October 9, 2014 (79 FR 60993). Due to necessary. The EPA reviewed the State’s North Dakota’s creation of the NDDEQ legal authorities to implement and incorporations and finds them by act of legislature, and revision and enforce section 112 requirements, and substantively equivalent to recodification of portions of the NDCC the recognition of the NDDEQ’s ability incorporations as they existed at the to receive delegated federal authority to and NDAC to grant the Department legal authority to implement and enforce the time of the 2014 approval of NSPS administer the State’s section 112 delegation of authority to the State program will affect the transfer from the State’s air pollution control rules, the EPA finds it necessary to revise the during the NDDH’s administration of NDDH to the NDDEQ of the authority to North Dakota’s environmental implement and enforce all incorporated, automatic delegation arrangement regulations.42 The State has made an unchanged federal NESHAP and MACT between the Agency and the State. adequate demonstration of enforcement requirements. As North Dakota is seeking approval of the transfer of its title V program to authority in their program description IV. Delegation of NSPS the NDDEQ concurrent with the State’s and has provided a State Attorney A. Introduction revisions to its section 111 program, the General’s opinion certifying the fullness EPA requested that the State of NDDEQ’s enforcement authority and Section 111 of the CAA authorizes the demonstrate the adequacy of its program the adequacy of its source waiver and EPA to establish a list of source and resources for implementing and public notification and disclosure of categories which contribute enforcing NSPS requirements information procedures. The EPA significantly to air pollution and independent of a fully approved reviewed the relevant sections of State authorizes the Agency to publish operating permits program. The EPA code related to enforcement and public regulations establishing federal evaluated the State’s section 111 notification, and finds them performance standards for new sources program based on the minimum substantively equivalent to within such categories. Section 111 program elements recommended in the incorporations as they existed at the performance standards for new sources Agency’s 1983 ‘‘Good Practices Manual time the title V program received full are categorically referred to as NSPS and for Delegation of NSPS and approval. The State also made a may individually be found in 40 CFR 41 NESHAPs.’’ The requirements set sufficient demonstration of adequate part 60. forth by this document are a state’s program resources for the Section 111(c) of the Act establishes demonstrations of: (1) Emission limits implementation and enforcement of the that the EPA may find a state program consistent with federal regulations; (2) NSPS as they will have the same as ‘‘adequate’’ for purposes of test methods consistent with federal implementing and enforcing the NSPS regulations; (3) reporting and resources that were previously allocated and delegate these authorities to the monitoring requirements; (4) by the State legislature that the EPA state. Delegation of authority confers enforcement authority against approved. The State’s submittal also upon the state primary implementation noncomplying sources; (5) waiver commits to reporting requirements and enforcement responsibility; procedures; (6) a source surveillance under the Performance Partnership however, the EPA also retains program; (7) a protocol for public Agreement between the North Dakota concurrent authority to enforce the and the EPA, as well as working with standards, and sole authority over those 40 See letter to Terry O’Clair, Director, Division of portions of the standards that may not Air Quality, North Dakota Department of Health, 42 For cross-referencing North Dakota’s be delegated. The usual method for ‘‘Automatic Delegation of Clean Air Act (CAA) unchanged incorporations of federal NSPS Section 111 Requirements,’’ from Carl Daly, requirements both before and after the transfer of establishing adequacy of a state’s Director, Air Program, February 27, 2014. authorities from the NDDH to the NDDEQ, see the program is to verify both the existence 41 For reference, this document may be found in document, ‘‘North Dakota NSPS Recodifications,’’ of an approved state title V permitting the docket for today’s notice. included in the docket for today’s notice.

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the EPA to provide information to the example sections in 40 CFR part 60 that and resources for oversight currently in Agency.43 may not be delegated to a state. place. We will initiate withdrawal of the Accordingly, EPA retains authority over program or rule if the corrective actions C. What NSPSs are we proposing to those portions of the CFR part 60 taken are insufficient. delegate? standards that may not be delegated. North Dakota’s request included If this delegation is finalized, all H. Should sources submit notices to the NSPS in 40 CFR part 60 as they existed questions concerning implementation EPA or the State? through July 1, 2015.44 This proposed and enforcement of the excluded For the delegated NSPS standards and delegation affects only the standards in the State of North Dakota authorities covered by this proposed implementation and enforcement should be directed to the EPA Region 8 action, if finalized, sources would authority for those standards which had Office. submit all of the information required been previously delegated to the State pursuant to the general provisions and under the previously approved D. How will statutory and regulatory the relevant subparts of the delegated automatic delegation program, and interpretations be made? NSPS (40 CFR part 60) directly to the which have now been incorporated If this NSPS delegation is finalized, State. The State is the primary point of unchanged into the State’s revised air the State will obtain concurrence from contact with respect to delegated NSPS. pollution control rules. the EPA on any matter involving the Sources do not need to send a copy to The NDDEQ would maintain primary interpretation of section 111 of the CAA the EPA. For those standards and responsibility for the enforcement of the or 40 CFR part 60 to the extent that authorities not delegated as discussed delegated section 111 standards within implementation or enforcement of these above, sources must continue to submit the State. If the NDDEQ determines that provisions have not been covered by all appropriate information to the EPA. such enforcement is not feasible and so prior EPA determinations or guidance. notifies the EPA, or on the occasion of I. How will unchanged authorities be E. What authority does the EPA have? the NDDEQ acting in a manner delegated to the State in the future? incongruous with the terms of this We retain the right, as provided by As stated in previous NSPS delegation delegation arrangement, the EPA may CAA section 111(c)(2), to enforce any actions, the EPA has approved North exercise its parallel enforcement applicable emission standard or Dakota’s mechanism of incorporation by authority pursuant section 113 of the requirement under section 111. We also reference of NSPS standards into the CAA with respect to sources within retain any authority in an individual State regulations, as they apply to both North Dakota subject to the section 111 standard that may not be delegated part 70 and non-part 70 sources. See, new source performance standards. according to provisions of the standard e.g., 79 FR 60993. All future section 111 There are some section 111 standards and retain the authorities stated in the requirements IBR into the State rules that may not be delegated to a state and preceding delegation agreement.45 will become effective on the date the which are not included in this North Dakota first received approval to requirement goes into effect according automatic delegation arrangement. The operate under an automatic delegation to the State’s updated rules and emission guidelines (EG) found in 40 arrangement that was effective on regulations. In the case of future CFR part 60, subparts Cb, Cc, Cd, Ce, Cf, December 8, 2014.46 (See 79 FR 60993). adoption of section 111 requirements, BBBB, DDDD, FFFF, and MMMM The delegation tables as of now and the EPA requests that North Dakota send require states to develop how it would look if this proposal is notice of the State’s intention to receive implementation plans for ‘existing’ finalized may be found in the docket for delegation of the requirements within facilities of certain source categories, this action. The docket item ‘‘Delegation 60 days of its incorporation of those which are then approved under a of CAA Authorities Overview,’’ also requirements into the State’s rules and separate process pursuant to section lists the authorities that cannot be regulations. The notification should 111(d) of the CAA. delegated to any state or local agency. include an official copy of the In addition, some portions of the regulation stamped, dated and signed by section 111 standards and the associated F. What information must the State the appropriate official, with the date of general provisions of part 60, by their provide to the EPA? adoption and the effective date in North own terms, may not be delegated to a The State must provide any Dakota. Within 30 days of receipt of state. The EPA Administrator retains information identified in the North Dakota’s notification, the EPA authority to implement those sanctions Performance Partnership Agreement to will reply with an acknowledgment of that require: (1) Approving equivalency the EPA, in accordance with the terms the delegation and will change the determinations and alternate test of the Agreement. relevant Region 8 electronic delegations methods; (2) decision making to ensure G. What is the EPA’s oversight role? of authority table (found at: http:// national consistency; and (3) EPA www2.epa.gov/region8/air-program) to rulemaking in order to implement. 40 The EPA oversees the State’s reflect the new delegation of authority. CFR 60.4(d) also contains certain NSPS decisions to ensure the delegated If there is a change in the effective date authorities that are not delegated to state authorities are being adequately for the section 111 requirement, North and local agencies. Additionally, the implemented and enforced. We will Dakota must notify the EPA as soon as document titled ‘‘INSERT’’ in the docket integrate oversight of the delegated possible. If the delay extends beyond for this proposal contains a list of authorities into the existing mechanisms the section 111 requirement compliance date, the EPA will implement and 45 43 For a detailed demonstration of North Dakota’s See the EPA’s August 26, 2009 letter to Director enforce the requirement until North program adequacy following the program elements Terry O’Clair, Division of Air Quality, North Dakota in the EPA’s 1983 ‘‘Good Practices Manual for Department of Health, ‘‘Delegation of Clean Air Act Dakota has fully incorporated the Delegation of NSPS and NESHAPs,’’ see, ‘‘NSPS New Source Performance Standards 2009.’’ requirement and the final effective date Program Description,’’ included in the submittal 46 79 FR 60993; October 9, 2014 (informing the has passed. document, ‘‘Title V Permit to Operate, MACT, public of EPA authorizing automatic delegation to The State also has the option of NESHAPs and NSPS Programs for Department of North Dakota via letter from Carl Daly, Director Air Environmental Quality, Division of Air Quality,’’ Program, EPA Region 8, to Terry O’Clair, Director, receiving partial delegation of a section found in the docket for today’s notice. Division of Air Quality, North Dakota Department 111 requirement, and the option to 44 NDAC 33.1–15–12–01.1. of Health (February 27, 2014). cancel the delegation of authority to

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implement and enforce previously programs, with the exception of the beyond those imposed by state law. For adopted requirements. Automatic EPA’s grant of interim approval of the that reason, this action: partial delegation of severable portions part 70 program. The State plans to rely • Is not a ‘‘significant regulatory of any standard requires that the State: on the date when the EPA signs the final action’’ subject to review by the Office (1) Clearly define the separable notice for purposes of notifying the state of Management and Budget under subcategory in the particular standard, legislature that the EPA has approved Executive Orders 12866 (58 FR 51735, or the specific separable subset of these revisions, which will provide for October 4, 1993) and 13563 (76 FR 3821, affected sources in the specific standard the transfer authority from NDDH to January 21, 2011); so that regulated sources and the public NDDEQ to be effective under State law. • Is not an Executive Order 13771 (82 know who is the implementing and Prior to the effective date of this FR 9339, February 2, 2017) regulatory enforcing authority; and (2) the approval, the State intends to take the action because Operating Permits applicable portions of the Federal necessary additional steps as specified Program approvals are exempted under standard must be adopted by IBR into in S.L. 2017, ch. 199, Section 1, to Executive Order 12866; the State regulations or rules with an ensure that NDDEQ rules and the • Does not impose an information additional, clear explanation of what NDDEQ would become federally collection burden under the provisions portions of the standard are not enforceable on the effective date of the of the Paperwork Reduction Act (44 included in the standard’s adoption into EPA’s approval. Unless and until the U.S.C. 3501 et seq.); the State rule. If the State does not want NDDEQ rules and agency become fully • Is certified as not having a to use automatic delegation for any of its effective under federal law, for purposes significant economic impact on a previously adopted section 111 of federal law the EPA recognizes the substantial number of small entities requirements, then the State may State’s program as currently approved under the Regulatory Flexibility Act (5 provide a list of those requirements under the North Dakota Department of U.S.C. 601 et seq.); which have been adopted and which the Health. • Does not contain any unfunded State wants to exclude from the mandate or significantly or uniquely VI. Statutory and Executive Order delegation process to the EPA. affect small governments, as described Review in the Unfunded Mandates Reform Act J. Proposed Action Under the CAA, the Administrator is of 1995 (Pub. L. 104–4); With this notice of proposed required to approve: • Does not have federalism rulemaking, the EPA is providing public • A state permit program submittal implications as specified in Executive notice and opportunity for public that complies with the provisions of the Order 13132 (64 FR 43255, August 10, comment on the Agency’s intention to Act and applicable federal regulations. 1999); approve revisions to the State of North 42 U.S.C. 7661a(d); 40 CFR 70.1(c), • Is not an economically significant Dakota’s section 111 program for 70.4(i). Thus, in reviewing permit regulatory action based on health or implementation and enforcement of program submittals, the EPA’s role is to safety risks subject to Executive Order NSPS requirements. The agency is also approve state choices, provided they 13045 (62 FR 19885, April 23, 1997); proposing straight delegation of all meet the criteria of the CAA and the • Is not a significant regulatory action applicable implementation and criteria, standards and procedures subject to Executive Order 13211 (66 FR enforcement authorities necessary to defined in 40 CFR part 70; 28355, May 22, 2001); regulate section 111 sources covered by • A state program for receiving • Is not subject to requirements of the relevant subparts of 40 CFR part 60 delegated authority to implement and section 12(d) of the National incorporated unaltered into State code. enforce emission standards and other Technology Transfer and Advancement This proposed delegation shall not be requirements for air pollutants subject Act of 1995 (15 U.S.C. 272 note) because construed as extending to those part 60 to section 112 if such program complies application of those requirements would subparts which cover existing sources with the provisions of the Act and be inconsistent with the CAA; and that require EPA approval of a state plan applicable federal regulations. 42 U.S.C. • Does not provide EPA with the that affects the implementation and 7412(l); 40 CFR part 63, subpart E. Thus, discretionary authority to address, as enforcement of federal emissions in reviewing section 112 program appropriate, disproportionate human guidelines for such source categories submittals, the EPA’s role is to approve health or environmental effects, using (section 111(d) sources); nor shall this state choices, provided they meet the practicable and legally permissible proposed action be construed as criteria of the CAA and the criteria, methods, under Executive Order 12898 delegating those authorities under standards and procedures defined in 40 (59 FR 7629, February 16, 1994). section 111 of the Act and part 60 which CFR parts 61 and 63; and In addition, this action is not are reserved by the Administrator of the • A state program for receiving approved to apply on any Indian EPA and not subject to delegation. The delegated authority to implement and reservation land or in any other area EPA is also proposing approval of enforce emission limitations for new where the EPA or an Indian tribe has revisions to the automatic delegation stationary sources subject to section 111 demonstrated that a tribe has arrangement between the EPA and the if such program complies with the jurisdiction. In those areas of Indian State of North Dakota to accommodate provisions of the Act and applicable country, the proposed rule does not the transfer of delegated NSPS federal regulations. 42 U.S.C 7411(c). have tribal implications and will not implementation and enforcement from Thus, in reviewing section 111 program impose substantial direct costs on tribal the NDDH to the NDDEQ. submittals, the EPA’s role is to approve governments or preempt tribal law as state choices, provided they meet the specified by Executive Order 13175 (65 V. Timing of Proposed Effective Dates criteria of the CAA and implement the FR 67249, November 9, 2000). All revisions to the title V operating requirements, standards and procedures permits program, and section 111 and defined in 40 CFR part 60. List of Subjects in 40 CFR Parts 60, 61, 112 programs would be federally Accordingly, this action merely 63, 70 and 72 enforceable as of the effective date of the proposes to approve state law as Environmental protection, Air EPA’s approval of the respective meeting federal requirements and does pollution control, Incorporation by revision and recodification of those not impose additional requirements reference, Intergovernmental relations,

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Title V, New source performance FOR FURTHER INFORMATION CONTACT: various Agreement States, as standards, National emission standards Ingrid Rosencrantz, Office of Radiation supplemented by site-specific license for hazardous air pollutants, Maximum and Indoor Air, Radiation Protection conditions, guidance documents . . . achievable control technology, Division, Mail Code 6608T, U.S. and the operational experience and Delegation of authority. Environmental Protection Agency, 1200 technical expertise of the regulatory Authority: 42 U.S.C. 7401 et seq. Pennsylvania Ave. NW, Washington, DC agency staff, constitute a comprehensive 20460; telephone number: 202–343– and effective regulatory program for Dated: October 24, 2018. 9290; fax number: 202–343–2304; email uranium in situ recovery operations Douglas Benevento, address: [email protected]. (ISR) facilities.’’ (emphasis added). Regional Administrator, EPA Region 8. SUPPLEMENTARY INFORMATION: Third, present market circumstances [FR Doc. 2018–23631 Filed 10–29–18; 8:45 am] suggest that the influx of new ISR I. Background BILLING CODE 6560–50–P license applications that was once On January 19, 2017, the U.S. anticipated, and that was motivation for Environmental Protection Agency (EPA) the proposal, is not likely to materialize. ENVIRONMENTAL PROTECTION proposed new health and environmental Therefore, there is less need for the rule, AGENCY protection standards under the Uranium which was intended to provide a more Mill Tailings Radiation Control Act of workable and efficient approach for 40 CFR Part 192 1978 (UMTRCA) (2017 Proposal).1 The addressing these expected new [EPA–HQ–OAR–2012–0788; FRL–9985–79– standards proposed in that action would applications, compared to existing OAR] have applied to byproduct materials mechanisms. produced by uranium in-situ recovery A. The EPA’s Legal Authority RIN 2060–AP43 (ISR) facilities and would have subsequently been implemented by the In the 2015 Proposal, the EPA Health and Environmental Protection U.S. Nuclear Regulatory Commission explained that it was ‘‘proposing these Standards for Uranium and Thorium (NRC) and NRC Agreement States. The new standards’’ under its authority in Mill Tailings EPA initially proposed new health and section 206 of UMTRCA which ‘‘authorizes EPA to promulgate general AGENCY: environmental protection standards for Environmental Protection standards for the protection of public Agency (EPA). ISR facilities on January 26, 2015 (2015 Proposal).2 However, the EPA decided health, safety, and the environment ACTION: Proposed rule; withdrawal. to re-propose the rule on January 19, from radiological and non-radiological hazards associated with . . . the SUMMARY: 2017, and seek additional public The U.S. Environmental processing and the possession, transfer, Protection Agency (EPA) is withdrawing comment on changes to the original proposal, including changes in the and disposal of byproduct material at its January 19, 2017, proposed rule sites at which ores are processed addressing health and environmental regulatory framework and approach, based on public comment and new primarily for their uranium and thorium protection standards under the Uranium source material content or which are Mill Tailings Radiation Control Act of information received from stakeholders. The EPA has not finalized either of used for the disposal of such byproduct 1978 (UMTRCA) that would have material.’’ 3 Many commenters stated applied to byproduct materials these proposals and is not doing so today. Instead, the EPA is withdrawing that this provision does not provide produced by uranium in-situ recovery authority for the type of standards that (ISR) and would have subsequently the 2017 Proposal, which superseded the 2015 Proposal. the EPA proposed. Other commenters been implemented by the U.S. Nuclear agreed with the EPA’s view that Regulatory Commission and its II. Why is the EPA withdrawing the UMTRCA provides authority for Agreement States. The EPA is 2017 Proposal? proposing these standards. The EPA withdrawing the proposed rule for three The EPA has decided to withdraw the evaluated and responded to these reasons. First, the EPA, informed in part 2017 Proposal for three reasons. First, comments in the 2017 Proposal.4 Many by feedback received on the proposal, stakeholders, including the NRC, raised of these same commenters subsequently has serious questions as to whether the significant concerns regarding the EPA’s submitted comments on the 2017 proposed rule as written is within EPA’s legal authority under UMTRCA to Proposal, arguing again that the authority under UMTRCA. Second, the propose these standards. Based on those proposed standards exceeded the EPA’s EPA no longer believes that a national significant concerns, we now have authority to establish ‘‘generally rulemaking to promulgate standards is serious questions concerning whether applicable standards.’’ 5 The NRC also necessary at this time, as the EPA the EPA has the legal authority under submitted comments stating that it does believes the existing regulatory UMTRCA to issue the regulations as not believe EPA has the authority to structures are sufficient to ensure the developed in the 2017 Proposal. develop standards of the type contained targeted protection of public health and Second, the EPA no longer believes in the 2017 Proposal. Some of these the environment at existing ISR that a national rulemaking to commenters raised new arguments to facilities. Third, present market promulgate standards is currently support their position that the proposed circumstances suggest that the influx of necessary as the Agency believes the standards exceed the EPA’s authority new ISR license applications that was existing regulatory structures are under UMTRCA. In light of the once anticipated and that was an sufficient to ensure the targeted comments provided on the various underlying motive for the proposal is protection of public health and the proposals, including by the NRC, the not likely to materialize. environment at existing ISR facilities. DATES: The proposed rule published on The NRC stated in its public comments 3 80 FR at 4163; See also 42 U.S.C. 2022(b)(1). January 19, 2017 (82 FR 7400), entitled that its ‘‘current regulations, at 10 CFR 4 82 FR at 7418–7419, 7421–7422. ‘‘Health and Environmental Protection part 40, Appendix A, and those of the 5 42 U.S.C. 2022(b)(1) uses the phrase ‘‘standards of general application,’’ while 42 U.S.C. 2022(b)(2) Standards for Uranium and Thorium uses the term ‘‘generally applicable standards.’’ We Mill Tailings,’’, is withdrawn as of 1 82 FR 7400. use these terms interchangeably throughout the October 30, 2018. 2 80 FR 4156. action.

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EPA now has serious questions as to and long-term stability standards ‘‘are prescriptive post-operational monitoring whether we have the legal authority to not generally applicable standards but time and data requirements and new finalize the standards that were are implementation criteria, and as prescriptive post-restoration proposed in the 2017 Proposal. such, encroach upon NRC’s authority requirements’’ as an ‘‘impermissible Most of the commenters’ objections to and impair the NRC’s ability to attempt by EPA to direct the compliance the EPA’s application of its authority effectively regulate its ISR licensees.’’ 12 of ISR operations.’’ 19 The Texas under UMTRCA in the 2015 Proposal The NRC also raised several new Commission on Environmental Quality centered around the meaning of the significant legal arguments in its (TCEQ) raised the same objection, phrase ‘‘standards of general comments to support its position that requesting that the EPA withdraw those application’’ in the statutory provision. had not been previously raised with particular requirements ‘‘because they Commenters opposing the proposed EPA.13 For example, the NRC argues exceed EPA’s authority to promulgate standards stated, ‘‘the proposed rules that ‘‘EPA’s authority to promulgate standards.’’ 20 TCEQ stated that were legally invalid and felt the EPA generally applicable standards, at least UMTRCA ‘‘confers the NRC and was overreaching its authority under for radiological material, is prescribed Agreement State programs . . . , not UMTRCA by proposing standards that by what is essentially EPA’s organic EPA, with authority to implement and are too detailed and prescriptive.’’ 6 authority, namely, the Reorganization enforce EPA’s standards,’’ and then These commenters stated that the EPA Plan No. 3 of 1970 (Reorganization asserted the EPA’s ‘‘proposed rules . . . ‘‘was redefining what UMTRCA Plan).’’ 14 The NRC asserts that ‘‘the go beyond the promulgation of established as the EPA’s role to set Reorganization Plan provided EPA with standards and address how those general standards’’ since these an express transfer of AEA authority to standards should be implemented and commenters did not believe UMTRCA set generally applicable standards ‘for enforced.’’ 21 provided the EPA with the authority to the protection of the general Other stakeholders submitted set standards that included ‘‘any environment from radioactive comments in support of the 2017 prescriptive implementation material,’’’ and that the Reorganization Proposal, reiterating their position that requirements.’’ 7 Other commenters that Plan ‘‘expressly prescribed this standard they believe the EPA has the authority supported the 2015 Proposal stated that setting authority by defining the term to propose these types of ‘‘generally ‘‘the proposed standards were an ‘standards’ to mean ‘limits on radiation applicable standards’’ under UMTRCA. appropriate application of the EPA’s exposures or levels, or concentrations or Based on the discussion above, EPA authority under the UMTRCA.’’ 8 quantities of radioactive material’— now has serious questions concerning In its response to the many comments essentially, numerical limits.’’ 15 NRC whether we have the legal authority to opposing the EPA’s proposed further asserts that UMTRCA’s issue the regulations as proposed in the application of its authority, the EPA in legislative history shows that ‘‘Congress 2017 Proposal. In conjunction with the the 2017 Proposal indicated that it was aware of and considered [this grounds for withdrawal discussed ‘‘disagree[d] with those commenters standard-setting authority in the below, this uncertainty as to our who believe the EPA has redefined its Reorganization Plan] when it enacted authority weighs in favor of role or overreached its authority in UMTRCA in 1978’’ and that ‘‘Congress withdrawing the 2017 Proposal. developing the new standards for ISR structured UMTRCA’s grant of authority facilities.’’ 9 The EPA stated that ‘‘the to the EPA Administrator upon this very B. Health and Environmental Protection new standards proposed in this action provision.’’ 16 The NRC points to several Justification for the Rule would apply the same requirements to excerpts from the legislative history to When EPA initiated this rulemaking, all ISR facilities and would establish support its claim that Congress intended there was already an effective system in general requirements . . . [that] the ‘‘that EPA’s generally applicable place providing environmental regulatory agency would be responsible standards under UMTRCA, for both oversight of ISR operations. As we for implementing. . .on a site-specific radiological and non-radiological explained in the 2015 Proposal, ‘‘in basis through the licensing process and materials, be in the form of numerical 1983, EPA originally promulgated would retain the authority to determine limits, namely, limits on concentrations regulations at 40 CFR part 192, Health when an ISR license can be of radiological and non-radiological and Environmental Protection terminated.’’ 10 material, quantities of such material, or Standards for Uranium and Thorium Several stakeholders, including the allowable doses or levels to individuals Mill Tailings, in response to the NRC, subsequently submitted comments from such material.’’ 17 statutory requirements of the Atomic on the 2017 Proposal, again stating that Other commenters disputed the EPA’s Energy Act [AEA] of 1954, as amended the proposed standards could not be authority to adopt regulatory by the Uranium Mill Tailings Radiation reasonably classified as ‘‘generally requirements that they alleged could not Control Act of 1978 (UMTRCA).’’ 22 The applicable standards’’ under UMTRCA reasonably be considered ‘‘generally 2015 Proposal further stated: and thus was outside EPA’s authority. applicable standards.’’ For example, the ‘‘Requirements currently applicable to In the 2017 Proposal, the EPA identified Uranium Producers of America (UPA) active uranium processing and disposal the proposed standards as falling into argued that the proposed standards sites, including ISR sites (i.e., Title II ‘‘exceed[s] EPA’s jurisdictional one of three different categories: (1) 18 sites) can be found in subpart D of 40 ‘‘Constituent concentration standards;’’ authority as set forth by UMTRCA.’’ CFR part 192 (hereafter ‘‘subpart D’’). (2) ‘‘initial stability standards;’’ and (3) UPA further criticized the ‘‘new Subpart D contains provisions for ‘‘long-term stability standards.’’ 11 In its managing uranium byproduct materials 12 EPA–HQ–OAR–2012–0788–0312 (comments of comments, the NRC asserted the initial the Nuclear Regulatory Commission) at 11. during and following the processing of 13 EPA–HQ–OAR–2012–0788–0312, pp. 8–21. uranium ores, and restoration of 6 82 FR at 7418. 14 Id. at pg. 12. 7 Id. 15 Id. 19 Id. 8 Id. 16 Id. at pg. 13. 20 EPA–HQ–OAR–2012–0788–0302 (comments of 9 Id. 17 Id. at pg. 14. the TCEQ) at 3. 10 Id. 18 EPA–HQ–OAR–2012–0788–0380 (comments of 21 Id. at 3–4. 11 82 FR 7405. Uranium Producers of America) at 7. 22 80 FR 4161.

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disposal sites following any such use of complicated and reflects differing views expansions, and restarts.30 This those sites.’’ 23 on the available data. expected influx of ISR license In the 2015 Proposal, under the In addition to the public stakeholder applications is no longer anticipated. heading ‘‘Why does EPA believe new comments mentioned above, most The NRC is currently reviewing standards are necessary?’’ the Agency importantly, the NRC, the agency tasked license applications for only three stated: ‘‘We believe that ISR-specific with implementing the program, expansions of ISR facilities and, for the standards are necessary because weighed in on the debate, stating in its next five years, the NRC expects only uranium ISR operations are very public comments that ‘‘the NRC staff one license application for an expansion different from conventional uranium has concluded that its application of the of one ISR facility and one license mills and the existing standards do not 10 CFR part 40, Appendix A regulations application for one new ISR facility.31 adequately address their unique aspects. to ISR facilities meets the AEA standard Compared to the expected influx of ISR In particular, we believe it is necessary of ‘adequate protection’ of public health license applications, and the 15 ISR to take a longer view of groundwater and safety and the facilities owned by 10 companies at the protection than has been typical of environment....’’28 time of the 2017 Proposal, at the end of current ISR industry practices. Although In considering these factors, as well as 2017 only approximately six ISR the presence of significant uranium the presence of an existing program that facilities were operating,32 with deposits typically diminishes the NRC (the implementing agency) production down 17% compared to late groundwater quality, current industry believes is sufficient, and the lack of 2016.33 According to the U.S. Energy practices for restoration and monitoring expected growth and status of the Information Administration (EIA), of the affected aquifer may not be industry as described further in the next ‘‘Domestic Uranium Production adequate to prevent either the further section of this withdrawal action, the Report,’’ 4th Quarter 2017, there are no degradation of water quality or the more EPA believes that the reasonably ISR facilities reported as operating in widespread contamination of envisioned public health and Texas, with Alta Mesa, Hobson, La groundwater that is suitable for human environmental benefits of the proposed Palangana reported as on ‘‘standby.’’ consumption.’’ 24 rulemaking are limited and do not Additional ISR facilities in New Mexico, In response to both proposals, the warrant EPA proceeding with its Texas, and Wyoming have been licensed EPA has received numerous comments proposed rulemaking. The existing but have not operated and only one has questioning the need or benefits of the regulatory structures, adequately undergone development. rule. For example, in the 2017 Proposal address the current environmental The proposal of generally applicable the EPA noted that ‘‘Industry concerns. national standards by EPA was driven commenters and others say that there is partly by the expectation of a significant no need for this rule because the EPA C. Current and Anticipated Market number of new facilities (which would has not identified an instance in which Conditions have also applied to operating wellfields an ISR operation has contaminated a Finally, the EPA believes that market at existing facilities), making these source of drinking water.’’ 25 In the 2017 forces themselves have lessened the proposed ISR-specific standards a more Proposal, the EPA also said: ‘‘Focusing need for such a rule. Initially, several immediate prerequisite to achieving the on the area of surrounding or adjacent factors, including the expected growth efficiency across all regulatory programs aquifers, the EPA acknowledges that the in this industry, led the EPA and the that the NRC acknowledged could be Agency does not have sufficient NRC to believe that regulation of ISR gained by a ‘‘regulatory regime . . . information to document a specific activities could be more workable and specific to ISRs.’’ 34 Today, the EPA instance of contamination of a public efficient if the EPA issued standards of questions whether this expected growth source of drinking water caused by an general application specific to the ISR in operating ISR facilities is likely to be ISR . . . [however,] the Agency remains facilities that the NRC would realized. concerned that the lack of data does not incorporate into its own regulations and Given this change in circumstances, demonstrate that no contamination is implement through its licensing completion of this rule is no longer occurring .... The monitoring activities.29 When these efforts began, expected to achieve the regulatory requirements in this proposal address the NRC expected as many as 23 ISR efficiency that was sought when this 26 the issue of lack of data.’’ (emphasis license applications for new facilities, rulemaking effort began. The NRC and added). In its comments on the 2017 the NRC Agreement States currently Proposal, UPA refers to the above 28 EPA–HQ–OAR–2012–0788–0312 at 1. regulate, through existing licenses, the statement: ‘‘EPA acknowledges there is 29 EPA–HQ–OAR–2012–0788–0006 (‘‘Regulation limited number of operating ISR no evidence of harm.... The EPA of Groundwater Protection at In Situ Leach facilities and such an approach has been provides no evidence to contradict Uranium Extraction Facilities,’’ Nuclear Regulatory workable in practice for this number of [NRC’s findings].’’ By contrast, the Commission Memorandum COMJSM–06–0001, January 17, 2006) at 2 (‘‘. . . the recent rapid rise 30 EPA–HQ–OAR–2012–0788–0405 (‘‘Uranium Natural Resources Defense Council in uranium prices and mining claims would Recovery Licensing Activities,’’ Presentation of the (NRDC) asserts that its comments indicate a significant future potential for new ISL Nuclear Regulatory Commission) at 10. facilities.’’); 80 FR at 4167 (‘‘In recent years, NRC ‘‘demonstrate impacts to ISL mined 31 Expectations for number of future licenses aquifers . . . such that the groundwater has recognized the desirability of ISR-specific regulations.... [T]he Commission determined in based on NRC/EPA telephone conversation on is substantially degraded and there will 2006 that the appropriate action was ‘initiation of November 28, 2017. be long-term harm to crucial natural a rulemaking effort specifically tailored to 32 U.S. Energy Information Administration: resources.’’ 27 As is evidenced by the groundwater protection programs at in situ leach ‘‘Domestic Uranium Production Report.’’ 4th comments, the debate is nuanced and (ISL) uranium recovery facilities.’ ’’); 82 FR at 7420 Quarter 2017 (February 8, 2018). The operating (‘‘In addition, the NRC acknowledges that efficiency facilities are Crow Butte in Nebraska and Lost could be gained by codifying its longstanding Creek, Nichols Ranch, Ross, Smith Ranch-Highland 23 80 FR 4163. effective regulatory regime into regulations specific and Willow Creek, all in Wyoming. Cameco 24 80 FR 4164. to ISRs. As described in the original proposal, this subsequently curtailed production at the Crow 25 82 FR 7404. rulemaking was initially prompted by the NRC’s Butte and Smith-Ranch Highland facilities (see 26 82 FR 7404. conclusion that ISR-specific rules are needed to http://www.cameco.com). 27 EPA–HQ–OAR–2012–0788–0380 at 2; EPA– create a more workable and sustainable regulatory 33 World Nuclear News, 20 November 2017. HQ–OAR–2012–0788–0390 (comments of the framework for this activity, and is not based on any 34 82 FR 7420. See footnote 29 for a more NRDC) at 4. specific instances of identified contamination.’’). complete citation.

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facilities. We do not see a need for the Energy Act (AEA), as added by section drug costs translated into a set payment EPA to continue investing its resources 206 of UMTRCA (42 U.S.C. 2022) and amount, would lead to higher quality of to complete this rule to develop a ‘‘more the Administrative Procedure Act (APA) care for beneficiaries and reduced workable and sustainable regulatory (5 U.S.C. 551 et seq.). expenditures to the Medicare program. framework’’ as originally anticipated IV. Impact Analysis DATES: To be assured consideration, when we proposed these ISR-specific comments must be received at one of standards, especially where current Because the EPA is not promulgating the addresses provided below, no later production is reduced and little or no any regulatory requirements, there are than 5 p.m. on December 31, 2018. growth is expected in the near future. no compliance costs or impacts The statutory authorities providing for associated with today’s final action. ADDRESSES: In commenting, please refer this ongoing regulatory and licensing to file code CMS–5528–ANPRM. V. Statutory and Executive Order function remain unchanged. Thus, the Because of staff and resource Reviews appropriate regulatory authorities may limitations, we cannot accept comments decide on a case-by-case basis to revise Today’s action does not establish new by facsimile (FAX) transmission. their own pre-existing regulations based regulatory requirements. Hence, the Comments, including mass comment on these authorities if they deem it requirements of other regulatory statutes submissions, must be submitted in one necessary to assist with their and Executive Orders that generally of the following three ways (please management of ISR facilities in a apply to rulemakings (e.g., the choose only one of the ways listed): particular state or local area. Unfunded Mandate Reform Act) do not 1. Electronically. You may submit In addition, we find support for our apply to this action. electronic comments on this regulation decision to withdraw the proposed rule Dated: October 18, 2018. to http://www.regulations.gov. Follow in the NRC’s comments on the 2017 Andrew R. Wheeler, the ‘‘Submit a comment’’ instructions. Proposal. As explained above, the EPA Acting Administrator. 2. By regular mail. You may mail developed the proposed standards partly based on its understanding, after [FR Doc. 2018–23583 Filed 10–29–18; 8:45 am] written comments to the following consultation with the NRC, that the BILLING CODE 6560–50–P address ONLY: Centers for Medicare & anticipated growth in the number of ISR Medicaid Services, Department of facilities highlighted a need for Health and Human Services, Attention: standards specific to ISR facilities, DEPARTMENT OF HEALTH AND CMS–5528–ANPRM, P.O. Box 8013, rather than continuing to apply HUMAN SERVICES Baltimore, MD 21244–8013. standards that were originally written to Please allow sufficient time for mailed address surface disposal of uranium Centers for Medicare & Medicaid comments to be received before the mill tailings.35 However, the NRC Services close of the comment period. expressed the following view in its 3. By express or overnight mail. You public comments on the proposed 42 CFR Chapter IV may send written comments to the rulemaking: [CMS–5528–ANPRM] following address ONLY: Centers for The NRC’s current regulations, at 10 CFR Medicare & Medicaid Services, part 40, Appendix A, and those of the various RIN 0938–AT91 Department of Health and Human Agreement States, as supplemented by site- Services, Attention: CMS–5528– specific license conditions, guidance Medicare Program; International ANPRM, Mail Stop C4–26–05, 7500 documents (e.g., NRC’s ‘‘Standard Review Pricing Index Model for Medicare Part Security Boulevard, Baltimore, MD Plan for In Situ Leach Uranium Extraction B Drugs 21244–1850. License Applications,’’ NUREG–1569), and For information on viewing public the operational experience and technical AGENCY: Centers for Medicare & expertise of the regulatory agency staff, Medicaid Services (CMS), HHS. comments, see the beginning of the SUPPLEMENTARY INFORMATION constitute a comprehensive and effective ACTION: Advance notice of proposed section. regulatory program for uranium in situ rulemaking with comment. FOR FURTHER INFORMATION CONTACT: recovery operations (ISR) facilities.36 Hillary Cavanagh, 410–786–6574 or the Considering the prevailing economic SUMMARY: We are issuing this advance IPI Model Team at IPIModel@ conditions affecting current and notice of proposed rulemaking cms.hhs.gov. projected production, which leads the (ANPRM) to solicit public comments on SUPPLEMENTARY INFORMATION: NRC now to expect significantly fewer potential options we may consider for future license applications, as opposed testing changes to payment for certain Inspection of Public Comments: All to the large increase that it expected at separately payable Part B drugs and comments received before the close of the time the rulemaking process was biologicals (hereafter called ‘‘drugs’’). the comment period are available for initiated (which was motivation for the Specifically, CMS intends to test viewing by the public, including any proposal), we conclude that whether phasing down the Medicare personally identifiable or confidential withdrawing this proposal is payment amount for selected Part B business information that is included in appropriate. drugs to more closely align with a comment. We post all comments international prices; allowing private- received before the close of the III. Statutory Authority sector vendors to negotiate prices for comment period on the following The statutory authority for this notice drugs, take title to drugs, and compete website as soon as possible after they is provided by section 275 of the Atomic for physician and hospital business; and have been received: http:// changing the 4.3 percent (post- www.regulations.gov. Follow the search 35 82 FR at 7402–3; 80 FR 4164–7. sequester) drug add-on payment in the instructions on that website to view 36 EPA–HQ–OAR–2012–0788–0312 at 1. model to reflect 6 percent of historical public comments.

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Comments received timely will also current Medicare payment system has the Social Security Act (the Act), which be available for public inspection as several features that may be causing authorizes testing models expected to they are received, generally beginning greater utilization of higher priced reduce program expenditures, while approximately 3 weeks after publication drugs.3 Under the current system, preserving or enhancing the quality of of a document, at the headquarters of Medicare pays doctors and hospitals a care furnished to beneficiaries. The the Centers for Medicare & Medicaid fee set at 6 percent of the price of the model under consideration would Services, 7500 Security Boulevard, drug so that the dollar amount of the include physicians, hospitals, and Baltimore, Maryland 21244, Monday add-on increases with the price of the potentially other providers and through Friday of each week from 8:30 drug rather than a set payment reflecting suppliers in selected geographic areas. a.m. to 4 p.m. To schedule an the service being performed. The The IPI Model test would include the appointment to view public comments, current buy-and-bill system also following components: phone 1–800–743–3951. requires physicians to purchase high- • Set the Medicare payment amount cost Part B drugs and wait for Medicare I. Executive Summary for selected Part B drugs to be phased reimbursement, exposing practices to down to more closely align with A. Purpose financial risk and jeopardizing their international prices; ability to operate and provide care in • The Medicare program and its their communities. Allow private-sector vendors to beneficiaries currently pay more for We are proposing to design the IPI negotiate prices for drugs, take title to many high-cost drugs than many other Model to achieve the following: (1) drugs, and compete for physician and 1 countries. The Centers for Medicare & Reduce expenditures while preserving hospital business; and Medicaid Services’ (CMS) Center for or enhancing the quality of care for • Increase the drug add-on payment Medicare and Medicaid Innovation beneficiaries; (2) ensure the United in the model to reflect 6 percent of (‘‘Innovation Center’’) is taking action States (U.S.) is paying comparable historical drug costs. on President Trump’s goal to lower drug prices for Part B drugs relative to other • costs for Medicare beneficiaries by Pay physicians and hospitals the countries by phasing in reduced add-on based on a set payment amount exploring a potential model that seeks to Medicare payment for selected drugs ensure the Medicare program pays structure; CMS would calculate what based on a composite of international CMS would have paid in the absence of comparable prices for Part B drugs prices; (3) reduce out-of-pocket costs for relative to other economically-similar the model, before sequestration, and included drugs for Medicare redistribute this amount to model countries. The potential International beneficiaries, and thereby increase Pricing Index (IPI) model would have participants based on a set payment access and adherence due to decreased amount. several goals, including: reducing drug costs; (4) maintain relative stability Medicare program selected expenditures in provider revenue through an These and other components of the and beneficiary cost-sharing for alternative drug add-on payment for potential model are described in greater separately payable Part B drugs (for furnishing drugs that removes the detail in this ANPRM. example, drug administered in current percentage-based drug add-on We are considering issuing a physician offices and hospital payments, which creates incentives for proposed rule in the Spring of 2019 outpatient departments), preserving or higher list prices and to prescribe higher with the potential model to start in enhancing quality of care for cost drugs; (5) reduce participating Spring 2020. The potential model would beneficiaries, offering comparable health care providers’ burden and operate for five years, from Spring 2020 pricing relative to international markets, financial risk associated with furnishing to Spring 2025. Of note, as discussed in removing providers’ financial incentive included drugs by using private-sector section III.I. of this ANPRM, the IPI to prescribe higher-cost drugs while vendors to purchase and take title to Model may have an impact on Medicaid creating revenue stability, minimizing included drugs; and (6) introduce drug rebates and payments, which we disruption to the current supply chain, greater competition into the acquisition continue to explore. and increasing Medicare efficiency and process for separately payable Part B With the release of this ANRPM, we value to reduce federal spending and drugs. taxpayer dollars. With this advance solicit public input on our intended notice of proposed rulemaking B. Summary of Major Provisions model design to inform our ongoing work to develop the IPI Model. (ANPRM), the CMS is soliciting public In section III. of this ANPRM, we feedback on key design considerations discuss the model concept design for II. Background for developing the IPI Model. the IPI Model. This IPI Model would A. Overview of Supply Chain The IPI Model aims to drive better focus on selected separately payable quality for Medicare beneficiaries and Part B drugs and biologicals (hereafter 1. Current Distribution System reduce Medicare drug spending by called ‘‘drugs’’). Specifically, the IPI offering comparable pricing relative to Model would initially focus on Part B In the U.S., Part B drugs that are other countries and addressing flawed single source drugs, biologicals, and administered in the outpatient setting incentives in the current payment biosimilars that encompass a high usually flow from the manufacturer system. Currently, Medicare pays percentage of Part B drug utilization and through drug wholesalers (or specialty substantially more than other countries spending. The Innovation Center would distributors) to the provider or supplier. for the highest-cost physician test this model under section 1115A of At each step of the process, the drugs administered drugs.2 In addition, the are sold to the next entity in the supply accessed via https://aspe.hhs.gov/pdf-report/ chain and that entity takes title to the 1 ‘‘Comparison of U.S. and International Prices for comparison-us-and-international-prices-top- drug. Distribution management systems Top Medicare Part B Drugs by Total Expenditures’’ spending-medicare-part-b-drugs. are employed to order drugs, track sales accessed via https://aspe.hhs.gov/pdf-report/ 3 ‘‘Comparison of U.S. and International Prices for and shipments, manage price and comparison-us-and-international-prices-top- Top Medicare Part B Drugs by Total Expenditures’’ customer lists, record financial spending-medicare-part-b-drugs. accessed via https://aspe.hhs.gov/pdf-report/ 2 ‘‘Comparison of U.S. and International Prices for comparison-us-and-international-prices-top- transactions, and support other industry Top Medicare Part B Drugs by Total Expenditures’’ spending-medicare-part-b-drugs. processes. Figure 1 provides a high-level

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view of this ‘‘buy and bill’’ system 4 and movement, financial flow, and contract existing relationships between the relationships.5 various entities, including product

The role of the health care provider directly negotiated agreements with their GPOs, for discounts that are tied to within the buy-and-bill system is to seek manufacturers. Similarly, the current prescribing, for example volume out low cost drug suppliers and drug distribution system accommodates discounts based on purchases of drugs purchasing mechanisms (for example, a variety of purchasing mechanisms and for all patients that are treated. Drug by joining a group purchasing specialized distribution processes, for wholesalers, distributors, and specialty organization (GPO)), order, buy (or use example, cold chain and product tracing pharmacies negotiate with financing), receive, and store drugs, compliance.7 manufacturers on the price they will administer drugs to patients, file claims Physicians generally purchase Part B pay to acquire drugs. When applicable, to bill insurers for payment, and collect drugs from a wholesaler, distributor, or contract pricing controls the price that patient cost-sharing. There are many specialty pharmacy. Hospitals generally the health care provider will pay to the different buying strategies that enable purchase for their outpatient wholesaler, distributor, or specialty physicians and hospitals to obtain lower departments through their hospital pharmacy, while shipping and handling drug prices. These strategies include pharmacy’s arrangement with a drug and other terms may vary. Through a using GPOs, group purchasing wholesaler. Physicians and hospitals process called the ‘‘chargeback arrangements, wholesaler/distributor also have arrangements with process,’’ manufacturers reduce the final price lists, the 340B Prime Vendor,6 and manufacturers, individually or through drug prices to wholesalers and other

4 The ‘‘buy and bill’’ system refers to health care 6 The Health Resources and Services participating public hospitals, community health providers purchasing drugs for administration to Administration (HRSA) administers the 340B Drug centers, and other safety-net health care providers patients followed by the submission of claims to a Pricing Program that allows certain hospitals and electing to join the 340B program. payer. other health care providers (‘‘covered entities’’) to 7 A cold chain ensures that a product maintains 5 Reprinted with permission. Drug Channels, obtain discounted prices on ‘‘covered outpatient a desired temperature all the way through the ‘‘Follow the Vial: The Buy-and-Bill System for drugs’’ (as defined at section 1927(k)(2) of the Act) Distribution and Reimbursement of Provider- from drug manufacturers. The 340B Prime Vendor supply chain from manufacturing to delivery/ Administered Outpatient Drugs,’’ October 14 2016, is responsible for securing subceiling discounts on administration. Product tracing allows a user to accessed via: https://www.drugchannels.net/2016/ outpatient drug purchases and discounts on other track every step of the supply chain. 10/follow-vial-buy-and-bill-system-for.html. pharmacy-related products and services for

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distributors to reflect the contract prices participated in the program, providing selection process. These time that were applied to health care drugs within approximately 180 consuming, imprecise mechanisms, providers’ drug purchases. Increasingly, Healthcare Common Procedure Coding along with other features of the CAP, specialty pharmacies are supplying System (HCPCS) billing codes limited the appeal of the program for oncology drugs to health care providers (including heavily utilized drugs in Part vendors. There was no guarantee for the that have chosen to remove themselves B) to physicians across the United States CAP vendors that the CAP payments from the buy and bill system—or private and its territories. The parameters for would cover their drug acquisition and payers are mandating use of ‘‘white the second round of the vendor contract operating costs. Participating physicians bagging’’ or ‘‘brown bagging’’ (that is, were essentially the same as those for reported that CAP requirements were pharmacy dispensed drugs delivered to the first round. While CMS received challenging to integrate into efficient the practitioner by the pharmacy or several qualified bids for the subsequent practice patterns and treatment regimes, patient) to control drug costs.8 However, contract period, shortly before the especially for oncologists who prescribe Medicare does not mandate use of or second contract period began, dosages that may change on the day of encourage white bagging or brown contractual issues with the successful treatment, and physicians who need to bagging.9 bidders led to the postponement of the administer antibiotics urgently. program, and the CAP has been Recently, we have heard from 2. Prior Competitive Acquisition suspended since January 1, 2009. stakeholders, including physician and Program hospital groups, and beneficiary Under the Medicare Prescription 3. Challenges With the Statutory CAP advocates, that a CAP-like approach Drug, Improvement and Modernization As described previously, the CAP with improvements, particularly in Act of 2003, which established section operated for a brief time from 2006 to regards to onsite availability of drugs, 1847B of the Act, we have authority to 2008. The Part B drug market has could potentially address concerns implement the ‘‘Competitive changed since that time. Higher cost about the financial burdens associated Acquisition Program’’ or ‘‘CAP’’ for Part drugs, particularly biologicals with furnishing Part B drugs and their B drugs that are not paid on a cost or manufactured by sole sources, are rising costs, and address challenges prospective payment basis. The CAP driving increasing Part B drug experienced in the CAP. Stakeholder was implemented in the mid-2000s. expenditures.10 Many of the highest feedback on the CAP has been The CAP was an alternative to the price drugs and biologicals available considered in the development of the average sales price (ASP) methodology today were not contemplated when the potential IPI Model described in this that is used to pay for the majority of CAP program was established. While ANPRM. In addition, comments Part B drugs, particularly drugs that are distribution channels have remained received on a Request for Information administered during a physician’s office concentrated, today’s providers and on a potential model to leverage the visit. Instead of buying drugs for their suppliers have access to more authority under the CAP for Part B offices, physicians who chose to sophisticated technologies such as drugs and biologicals that was included participate in the CAP would place a electronic ordering systems and virtual in the Calendar Year 2019 Hospital patient-specific drug order with an inventory management systems. Outpatient Prospective Payment System approved CAP vendor; the vendor Since 2009, physicians have faced (OPPS) and Ambulatory Surgical Center would provide the drug to the office and growing financial risks under the buy (ASC) Payment System proposed rule then bill Medicare and collect cost- and bill approach, as the prices of Part (83 FR 37046) and comments received sharing amounts from the patient. Drugs B drugs have increased. Hospitals have on the HHS Blueprint to Lower Drug were supplied in unopened containers varying ability to negotiate discounts, so Prices and Reduce Out-of-Pocket Costs (not pharmacy-prepared individualized some hospitals face similar financial (83 FR 22692) were considered. doses like syringes containing a challenges for the outpatient drugs they patient’s prescribed dose). When the provide. Further, the rising costs of B. Rising Cost of Prescription Drugs CAP was in place, most Part B drugs prescription drugs in the Medicare Part 1. Medicare Spending used in participating physicians’ offices B program strain federal resources as Medicare Part B drug expenditures were supplied by the approved CAP well as beneficiaries’ wallets. have increased significantly over time. vendor. Unlike the buy and bill process As envisioned, the CAP had the From 2011 to 2016, Medicare FFS drug that is still used to obtain many Part B potential to reduce risk for enrolled spending increased from $17.6 billion to drugs, physicians who participated in physicians and Medicare expenditures. $28 billion under Medicare Part B, the CAP did not buy or take title to the As implemented, the CAP was tied to representing a compound annual growth drug. Physician participation in the CAP the ASP payment under section 1847A rate (CAGR) of 9.8 percent, with per was voluntary, but physicians had to of the Act and did not achieve savings.11 capita spending increasing 54 percent, elect to participate in the CAP. CAP In the aggregate, the submitted bids from $532 to $818.12 The number of drug claims were processed by a could not exceed a threshold that was Medicare Part B FFS beneficiaries and designated carrier. based on ‘‘point in time’’ ASP data CMS conducted bidding for CAP combined with historical utilization the number of these beneficiaries who received a Part B drug increased over vendors in 2005. The first CAP contract data. The submitted bids fed into the the 5-year period (2011 through 2016). period ran from July 1, 2006 until composite bid analysis and vendor December 31, 2008. One drug vendor However, the increase in total Medicare drug spending during this period is 10 Medicare Part B Drug Spending Dashboard 8 Robinson and Howell. Specialty accessed via: https://www.cms.gov/Research- more fully explained by increases in the Pharmaceuticals: Policy Initiatives to Improve Statistics-Data-and-Systems/Statistics-Trends-and- prices of drugs and mix of drugs for Assessment, Pricing, Prescription, and Use. Health Reports/Information-on-Prescription-Drugs/ those beneficiaries who received them Affairs 2014:33(10);1745–50. MedicarePartB.html. than by increases in Medicare 9 ‘‘Brown bagging’’ is a term used when the 11 Evaluation of the Competitive Acquisition patient obtains the drug at a pharmacy and then Program for Part B Drugs: Final Report, December enrollment and drug utilization. The brings it to the physician for administration. ‘‘White 2009, accessed via: https://www.cms.gov/Research- bagging’’ is a term used when the specialty Statistics-Data-and-Systems/Statistics-Trends-and- 12 Spending and Enrollment Data from Centers for pharmacy ships directly to the physician office or Reports/Reports/downloads/CAPPartB_Final_ Medicare and Medicaid Services Office of hospital outpatient department for administration. 2010.pdf. Enterprise Data and Analytics.

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CAGR in number of Medicare Part B would supply physicians, hospital • Should we introduce health care FFS beneficiaries is less than 1 percent outpatient departments, and other provider bonuses to incentivize between 2011 and 2016. included providers and suppliers with reductions in cost or utilization relative the drugs and biologicals that CMS to a benchmark? 2. International Prices Relative to U.S. would include in the model in all of the Prices A. Model Vendors model’s selected geographic areas. Drug acquisition costs in the United Similar to the CAP, the model vendors, 1. Testing Alternative to CAP States exceed those in Europe, Canada, rather than the health care providers, Requirements and Japan, according to a Department of would take on the financial risk of As CMS develops the IPI Model, we Health and Human Services (HHS) acquiring the drugs and billing analysis 13 of drug acquisition costs for seek to minimize disruption within the Medicare. Instead of paying the model drug distribution system while Medicare Part B physician-administered vendors based on bid amounts, as increasing competition, lowering U.S. drugs. The HHS analysis compared section 1847B of the Act prescribes for drug prices, and removing the incentive United States drug acquisition costs for the CAP, under the IPI Model Medicare for higher list prices. Under the CAP, a set of Medicare Part B physician- would pay the vendor for the included the CAP vendor had to acquire the CAP administered drugs to acquisition costs drugs based on international prices drug and ship the drug to the ordering in 16 other developed economies— discussed in section III.D. of this physician after receiving a beneficiary- Austria, Belgium, Canada, Czech ANPRM, which would be intended to specific order. Under the IPI Model we Republic, Finland, France, Germany, lower the amount Medicare pays for are considering, vendors would have the Greece, Ireland, Italy, Japan, Portugal, included drugs and beneficiary cost- flexibility to offer a variety of delivery Slovakia, Spain, Sweden, and the sharing. The model vendors would have United Kingdom (UK). flexibility to offer innovative delivery options, including beneficiary-specific Among the 27 products included in mechanisms to encourage physicians prescriptions, pre-ordering approaches the analysis, acquisition costs in the and hospitals to obtain drugs through such as onsite inventory management U.S. were 1.8 times higher than in the vendor’s distribution arrangements, solutions, and other arrangements that comparator countries.14 Acquisition such as electronic ordering, frequent would not require physicians and cost ratios ranged from U.S. prices being delivery, onsite stock replacement hospitals to purchase the drugs or face on par with international prices for one programs, and other technologies. greater buying costs. Physicians and drug, to U.S. prices being up to 7 times Physicians and hospitals in the model hospitals would select the vendors that higher than the international prices. test would select the vendors that best offer delivery mechanisms that best There is variability across the 16 provide customer service and support meet their patient care needs, practice countries in the study as well, with no beneficiary choice of treatments, and size and location(s), and support needs. one country consistently acquiring would be able to engage with multiple Agreements between the vendors and drugs at the lowest prices. The U.S. has vendors for different drugs and to physicians/hospitals would establish the highest ex-manufacturer prices for change vendors. In addition to the the terms of their arrangements and 19 of the 27 products. Medicare drug administration payment would include appropriate guardrails to As a result, Medicare beneficiaries that would still be made to physicians protect all parties, including and the Medicare program are bearing and hospitals, the model would pay beneficiaries and the Medicare program. unnecessary, potentially avoidable costs physicians and hospitals a ‘‘drug add-on CMS seeks feedback on whether CMS for Part B drugs. amount’’ that would be different from should be a party to and/or regulate III. Model Concept Design the current drug add-on amount. these agreements, and whether the Outside of the designated model test agreements should specify obligations to The potential IPI Model would areas and for drugs not included in the ensure the physical safety and integrity leverage and improve upon the CAP model, health care providers would of the included drugs until they are approach by paying physicians and continue to use the buy and bill administered to an included beneficiary, hospitals for drug-related costs, approach and the current Medicare FFS how drug disposition would be providing more flexibility for drug payment policies would apply. handled, and data sharing methods, ordering and distribution, and by having This ANPRM describes features of a confidentiality requirements, and model vendors compete for business potential model in more detail, such as potentially other requirements. from physicians and hospitals. Through how an international pricing index 2. Eligible Vendors the potential IPI Model, we seek to test could be developed and tested. We ways to remove physicians and intend to waive program requirements Under the potential IPI Model, we hospitals outpatient departments from to the extent necessary to test the model would intend to allow greater flexibility the buy and bill process, without design that we would implement than under the CAP in the types of creating undue disruption to the through notice and comment entities that could be selected as a distribution system. rulemaking. We seek feedback on a model vendor (in accordance with CMS is considering contracting with a applicable laws), and to minimize the number of private-sector vendors that number of potential model elements described in the following sections of impacts on drug distribution processes. Under the CAP, specialty pharmacies 13 ‘‘Comparison of U.S. and International Prices this ANPRM. These include: for Top Medicare Part B Drugs by Total • What limitations would be in place were the only entities that met the CAP Expenditures’’ accessed via https://aspe.hhs.gov/ on the entities that could participate as vendor criteria, and only one such pdf-report/comparison-us-and-international-prices- vendors (e.g. pharmacies, vendor participated in the program. To top-spending-medicare-part-b-drugs. manufacturers, providers themselves)? increase competition, the IPI Model 14 Acquisition cost ratios ranged from U.S. prices • being on par with international prices for one drug, Which countries should be would potentially allow entities such as to U.S. prices being up to 7 times higher than the included in calculating an international GPOs, wholesalers, distributors, international prices. There is variability across the pricing index? How frequently should specialty pharmacies, individual or 16 countries in the study as well, with no one international data be updated? groups of physicians and hospitals, country consistently acquiring drugs at the lowest • prices. The U.S. has the highest acquisition costs for What should be the schedule for manufacturers, Part D sponsors, and/or the vast majority of the 27 products. phasing in the spending target? other entities to perform the role of

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model vendor as long as they could 3. Model Vendor Responsibilities 4. Model Vendor Payment satisfy the vendor qualification The model vendors’ responsibilities Physicians and hospitals would pay requirements. We are interested in ways would be based on the responsibilities the model vendor for distribution costs to minimize any potential concerns that of the CAP contractor under section and would collect beneficiary cost- could arise by allowing a broader set of 1847B of the Act and would be specified sharing, including billing supplemental entities to be vendors, and how health in a model vendor agreement. The insurers.15 Informational drug claims care providers operating as vendors model vendors would be responsible for would be submitted to the Medicare might be able to operate in all such activities as— Administrative Contractor (MAC) along geographic areas included in the model. • Negotiating with manufacturers for with claims for drug administration. We seek input on the types of entities the vendor’s drug acquisition prices for In addition, similar to how the CAP that would be allowed to be model included drugs; operated, under the model, vendors vendors, the potential for perverse • Establishing mechanisms for the would submit claims to Medicare and incentives that could be introduced by model vendor to take title to, but not would be paid an applicable amount for potentially allowing health care necessarily physical possession of, the Part B drug that was administered to providers to be model vendors and/or included drugs, and arranging for the an included beneficiary. The model allowing model vendors to charge distribution of included drugs to payment amounts to vendors for health care providers for distribution- participant health care providers for included drugs would be updated related activities, and whether there administration to included quarterly. The payment amount is should be guardrails in place to prevent beneficiaries; described in section III.D. of this perverse incentives. • Establishing mechanisms within the ANPRM. Unlike the CAP, under the We would require that model vendors vendor’s arrangements with potential model CMS would not solicit purchase and take title to the included manufacturers, physicians, hospitals, bid amounts for drugs. To the extent it drugs, but to allow for innovative and other included providers and would be legally allowable, vendors’ distribution approaches, model vendors suppliers to receive compensation for agreements with physicians and would not be required to take physical vendor services; hospitals could include provisions for possession of the drugs. For example, if • Implementing processes for delivery fees and other vendor costs.16 a manufacturer establishes a limited participant health care providers to On a periodic basis, for example distribution program, model vendors enroll with the vendor and to obtain quarterly, CMS would ensure that could negotiate with the manufacturer included drugs; payment to the model vendors for ways to purchase the drug while the • Meeting applicable licensure administered drugs is substantiated by established limited distribution entity requirements in each State in which the the physician and hospital submitted would continue to ship the drug to the vendor would supply included drugs claims. physician or hospital for administration. and be enrolled in Medicare as a We seek feedback on other options for We would expect that all model participating supplier, unless the model model vendor payment, including vendors would operate on a national vendor distributes included drugs under whether payment should include an basis; that is, model vendors potentially contract with one or more entities, in administration fee from CMS and would be required to serve all of the which case the vendor must require that whether vendors’ agreements with selected model geographic areas and such entities meet applicable licensure physicians and hospitals could include supply all included drugs to the requirements and be enrolled in provisions for delivery fees and other physicians and hospitals that enroll Medicare as a participating supplier; vendor costs. with the vendor. The model would • Establishing mechanisms for We are considering whether, given the promote competition among multiple physicians and hospitals to notify the flexibilities that model vendors and national vendors; vendors would vendor of the disposition of an included physicians and hospitals would have compete for agreements with physicians drug; under the model, the model should and hospitals and other health care • Submitting claims for included include dispute resolution support, and providers that would be included in the drugs in accordance to model billing if so, what such support should include. model. Physicians and hospitals would instructions established by CMS; 5. Model Vendor Selection not be required to use only one vendor; • Paying manufacturers for included we would encourage model participants drugs that were administered; We intend to operate a competitive to obtain drugs from the most cost • Operating vendor-administered selection process to identify the model effective model vendors. Enrolling with payment arrangements, such as vendors that would participate in the IPI more than one vendor would allow indication based pricing, or outcomes- Model. As we solicit applications for physicians and hospitals more options based agreements; potential model vendors, we would for obtaining drugs timely, although the • Developing and implementing encourage a variety of qualified entities minimum requirement would be that program integrity safeguards to ensure to apply, including new business model participants maintain enrollment that all model requirements and arrangements that could fulfill the with at least one vendor in order to applicable Medicare requirements are vendor role on a national basis. We furnish included drugs to the followed; intend to select three or more model beneficiaries they serve timely. • Participating in model activities, vendors so that physicians and hospitals Model vendors would operate including monitoring and evaluation have a number of vendors from which enrollment for physicians and hospitals activities; to obtain drugs and so that model and would send periodic enrollment • Providing support and technical vendors compete on the basis of reports and other documentation to assistance to participant health care CMS to support model operations. In providers; and 15 We envision that existing Medicare crossover addition, model vendors would be • Performing other functions and claims processing steps could be leveraged to requirements as specified in the model support billing supplemental insurers. prohibited from paying rebates or 16 We envision that model vendors would volume-based incentive payments to vendor agreement, such as compete, in part, for physicians and hospitals based physicians and hospitals. administrative requirements. on low fees.

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customer service and cost, but solicit • We are also interested in public B. Model Participants, Compensation comment as to whether three vendors is comment on the potential guardrails and Selected Geographic Areas an appropriate floor. The solicitation for that would be appropriate if 1. Model Participants model vendors would specify in more manufacturers and/or health care detail the model vendor requirements. providers could serve as model vendors. IPI Model participants would include The model vendor solicitation would Also should CMS receive shared savings all physician practices and hospital also specify the selection factors, which based on the difference between a outpatient departments (HOPDs) that may include: The ability to negotiate model vendor’s negotiated price and furnish the model’s included drugs in with manufacturers; the ability to CMS’ payment amount? If so, how the selected model geographic areas. ensure product integrity; The ability to would CMS operationalize this shared CMS is considering whether to also establish a customer service/grievance savings approach? include durable medical equipment process; financial performance and • What should be the potential (DME) suppliers, Ambulatory Surgical solvency; record of integrity and the responsibilities of model vendors and Centers (ASCs), or other Part B implementation of internal integrity model participants (included providers and suppliers that furnish the included drugs. Model participation measures; internal financial controls; physicians, hospitals, and potentially would be mandatory for the physician maintenance of appropriate licensure to other providers and suppliers) under the practices, HOPDs, and potentially other purchase drugs and biologicals; and model. Specifically, are there ways that providers and suppliers, in each of the ability to meet the model vendor vendors and model participants could agreement requirements within 6 selected geographic areas. collaborate to enhance quality and We intend to provide a more months. reduce costs? comprehensive list of health care • We would refuse to establish a model What would be the ability of the providers included under the model if vendor agreement with an entity for potential types of entities that could be a proposed rulemaking moves forward. reasons including— model vendors to negotiate for drug For purposes of the potential IPI • Exclusion of the entity under prices that would be at or below the IPI Model, beneficiaries would be included section 1128 of the Act from Model payment? Would certain types of in the model if they are furnished any participation in Medicare or other entities have advantages or face of the included drugs by a model Federal health care programs; or additional challenges? participant in one of the selected • Past or present violations or • Are there processes that model geographic areas. More specifically, the misconduct related to the pricing, vendors could use to increase their price following beneficiary eligibility criteria marketing, distribution, or handling of negotiation leverage with manufacturers would be used based on the date that drugs covered under the Medicare and lower their potential loss exposure the included drug was furnished— program. without increasing burdens on • The beneficiary is enrolled in We would similarly include reasons beneficiaries, physicians, and hospitals? Medicare Part B; • to terminate a model vendor in the • Are there unsurmountable The beneficiary is not enrolled in model vendor agreement. In addition, to challenges related to physicians and any group health plan or United Mine ensure that selected model vendors Workers of America health plan; 17 and hospitals paying for distribution costs • would be able to perform their and to continue to collect beneficiary Medicare FFS is the primary payer. responsibilities under the model vendor cost-sharing, including billing Medicare FFS beneficiaries who are agreement without influence from supplemental insurers? not eligible for inclusion in the model parties that have a financial interest would continue to receive drugs that • Should physicians and hospitals related to included drugs or were obtained by their health care receive bad debt payments if participating health care providers, we provider using the buy and bill beneficiaries fail to satisfy cost-sharing are considering including conflict of approach. obligations? Under the IPI Model, model interest requirements similar to those • established for the CAP in 42 CFR Is there a need for the model to participants in the selected geographic 414.912. include billing and dispute resolution areas would have to enroll with at least support, and if so, what should such one model vendor and obtain included 6. Requests for Feedback and support include? drugs from a model vendor for Information • Should CMS pay the model vendors administration to included Medicare We are inviting public comment on or should providers pay the model FFS beneficiaries. Model participants the factors that would be necessary to vendors for the responsibilities would have to follow model-specific allow CMS to identify entities that associated with taking title to drugs and billing instructions to submit would most likely perform the distributing drugs? What incentives are informational drug claims and the responsibilities of a model vendor established if CMS pays the model model add-on payment. To reduce efficiently and effectively with minimal vendors? beneficiary impact, model participants start up time. • What should be the reasons for would continue to collect beneficiary • We seek information about the excluding entities from serving as a cost-sharing. We are considering ways types of entities that could serve as model vendor or terminating a model to ensure the reconciling of beneficiary national vendors for the model. Should vendor agreement, as well as cost-sharing that model participants CMS require model vendors to enroll appropriate conflict of interest any included health care provider? If requirements? 17 The United Mine Workers of America Health • and Retirement Funds (‘‘The Funds’’) is a Medicare included physicians and hospitals could Should the role for the model Health Care Prepayment Plan (HCPP) and is the be model vendors, should they be vendors include entering into value- Medicare payer for non-facility Part B services. As required to be a vendor for other health based payment arrangements (for such, providers bill the Funds for Medicare Part B care providers, and should they have to example, indication-based pricing or services. The Funds’ payment to the provider includes the Medicare amount plus the Medicare operate on a national basis? Should any outcomes-based agreements)? And if so, coinsurance and deductible amount, making it vendor be required to provide services should there be requirements around unnecessary for the provider to submit claims to on a national basis? these arrangements? two payers.

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would be collecting. An administrative located outside CBSAs would not be a. Potential Alternative to the ASP Add- approach that deducts the cost-sharing included in the randomization to On amounts from Medicare payments made intervention or comparison groups. CMS would base payment for other services to the model Health care providers outside of the calculations for the alternative participants could be feasible and randomized geographies could compensation on six percent (+6 would be less disruptive for potentially have the opportunity to opt percent) of the included Part B drugs’ beneficiaries. into the model. However, health care ASP, which would represent an increase 2. Model Geographic Areas providers that are not part of the from the +4.3 percent add-on that randomized treatment and control currently is paid due to sequestration, The model would require the groups, but that opt into the model, participation of physician practices and and would support appropriate drug would not be included in the evaluation utilization under the model structure. HOPDs (and potentially other providers sample. and suppliers) in selected geographic That is, in total the alternative areas across the U.S. and its territories, 3. Potential Drug Add-on Payment compensation for model participants which would allow the Innovation would approximate the expected add-on Medicare Part B covers drugs amount for included drugs in the Center to gain experience and insight administered by physicians in physician into using an alternative payment absence of the model, before offices and hospital outpatient sequestration. Because the alternative methodology for drugs included in the departments and certain drugs in other model. We anticipate the selected compensation would not be paid in a settings. In addition to payment for drug manner that is tied directly to the ASP geographic areas would include 50 administration, Medicare Part B percent of Medicare Part B spending on of an administered drug, there would typically pays for separately payable not be an incentive for use of higher cost separately payable Part B drugs. The Part B drugs at the average sales price mandatory participation of physician drugs when an alternative is available. (ASP) of a given drug, plus 6 percent of As described in section III.D. of this practices and HOPDs (and potentially the ASP as an add-on (with other health care providers that furnish ANPRM, Medicare payment for the sequestration, the actual payment included drugs) in the selected drugs themselves would be to the model allowance is ASP + 4.3 percent). This geographic areas would avoid having vendors; model participants would no add-on payment can help to cover the expected financial performance in the longer ‘‘buy and bill’’ Medicare for costs of drug ordering, storage and model influence the physician practice/ included Part B drugs administered to handling borne by physicians and HOPD’s decision to participate or not. It included beneficiaries. Payment for hospitals, payments to join group also would ensure we capture the drug administration services, when purchasing organizations (GPOs) or experiences of various types of applicable, would continue to be other entities with similar purchasing physician practices and HOPDs in separately billed by model participants arrangements, as well as a portion of the different geographic areas with varying to Medicare; there would be no change characteristics and historic utilization drug costs themselves, in instances in the payment for drug administration patterns. when the drug is acquired at a price services under the model. Beneficiary For the IPI Model, we are considering more than ASP. However, the drug add- cost-sharing would apply to the model- a randomized design with the on payment may encourage increased specific alternative compensation randomization to intervention and utilization, particularly of higher-cost payments and for model payments for comparison groups occurring at the drugs, since doing so increases revenue included drugs. geographic unit of analysis. There are for the physician or hospital when the b. Description of Alternative Add-on two main factors that need to be add-on is higher than drug acquisition- Payment Amount considered when selecting geographies related costs. for the model: (1) The most appropriate This section describes our thinking on Model participants would be paid a geographic unit (ZIP code, county, core alternative methods for making the drug set payment amount per encounter or based statistical area, state, etc.) that add-on payment a set payment amount per month (based on beneficiary panel reflects how care is delivered in rather than as a percentage of ASP. We size) for an administered drug, which markets, and (2) the geographic scope of intend to structure the potential IPI would not vary based on the model the model, or the number of geographic model such that physicians and payment for the drug itself. We are units needed to generate statistically hospitals would be incentivized to seek considering whether to set a unique credible findings. Typically, the more out lower cost drugs for their payment amount for each class of drugs, geographic units available for random beneficiaries, reduce inappropriate physician specialty, or physician assignment to the model’s intervention utilization, continue to pay for certain practice (or hospital). That is, there and comparison groups the better. distribution costs, continue to bill would be a set payment amount per However, there is a tradeoff between Medicare for drug administration, albeit administered drug that would be based the size of the geographic unit and the following model-specific instructions, on—(1) which class of drugs the number of units available for and continue to collect beneficiary cost- administered drug belongs to; (2) the assignment. We are considering using sharing for included drugs. The goals for physician’s specialty; or (3) the CBSAs (Core Based Statistical Areas) as the model add-on payments would be to physician’s practice. If used, specialties the primary unit of analysis in the hold health care providers harmless to would likely be defined broadly rather model. CMS is further considering current revenue to the greatest extent than at a subspecialty level (for whether it would be necessary to use possible; create an incentive to example, ophthalmology rather than larger geographic units such as encourage appropriate drug utilization; neuro-ophthalmology) given the aggregations of CBSAs (metropolitan remove the incentive to prescribe difficulty of doing this through claims statistical areas or combined statistical higher-cost drugs; and create incentives data, although CMS may identify an areas) to avoid the potential for routine to prescribe lower-cost drugs in order to alternative approach. We would shifts in the site of care to a practice reduce beneficiary cost sharing. We calculate the final payment amount, by location with a different assignment have considered several different drug class, physician specialty, or under the model. Geographic areas structures for the set payment amount. physician practice, annually based on

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the +6 percent of ASP revenue that • How should a per month alternative multiple source drugs as defined in model participants would have garnered add-on payment be determined? How section 1847A of the Act. without sequestration in the most recent and how often should a beneficiary 2. Potential Included Drugs year of claims data. panel size be determined? Total model payments to a model • The potential inclusion of a bonus In Years 1 and 2 of the potential IPI participant would vary based on pool. Should a bonus pool be included Model, we would include single source utilization under an encounter-based in the model? If so, how should the drugs, biologicals, biosimilars, and model. To incentivize reduced model participant bonus pool be multiple source drugs with a single utilization where appropriate, CMS is constructed to meet the goals of the manufacturer that we identify from considering creating a bonus pool, model to incentivize the use of lower- what we believe are reliable sources of where model participants would cost drugs and clinically appropriate international pricing data, prior to direct achieve bonus payments for prescribing utilization? How could a bonus pool be data collection, as discussed in section lower-cost drugs or practicing evidence- constructed to best protect and enhance III.D. of this ANPRM. In Years 3, 4 and based utilization. Importantly, as quality under the model? How should 5, we would broaden the scope of described in section III.F.3. of this CMS handle variable low-volume included drugs to incorporate more of ANPRM, we would monitor drug estimates and missing data values when these single source drugs and biologicals as more sources of utilization carefully throughout the assessing performance for purposes of a international pricing data become model to ensure beneficiary access to bonus pool? drugs is not compromised. • available, and we are considering The potential phase in of an further increasing the number of Part B 4. Requests for Feedback and alternate provider compensation. drugs included in the model as Information Should CMS phase in a change from discussed later in this section. We We welcome input from stakeholders percentage-based add-on payments to would begin with these two broad on the potential approach for defining set payment amounts, or should set groups of drugs—single source drugs model participants, selecting geographic payment amounts be implemented in and biologicals—as they encompass areas, and calculating an alternative to Year 1 of the potential IPI Model? most drugs used by most physician • the ASP add-on for the IPI Model. How should CMS implement an specialties that bill under Part B. At a Specifically, we would like to receive administrative process to account for minimum, we believe that we could information on which alternative add- beneficiary cost-sharing for drugs that is begin the model by including most of on option is preferable and how the collected by model participants? the HCPCS codes that appear in the 19 specific payment methodology might be C. Included Drugs recent HHS report; these drugs designed. For example: represent over 50 percent of Part B drug • The exclusion of certain types of 1. Background allowed charges in 2017. As we physician practices and/or HOPDs from The Part B drug benefit includes consider including more drugs over the model. For example, should we many types of drugs and encompasses a time, we would prioritize single source consider excluding small physician variety of care settings and payment drugs and biologicals. We are also practices/HOPDs (for example, those methodologies. Of the approximately considering including HCPCS codes for with 3 or fewer physicians) from the $28 billion per year of FFS Part B drug drugs and biologicals that are clinically model or establish a low-volume spending in 2016, about $23.6 billion or comparable, but not interchangeable, to those initially included in the model, threshold that would exclude those 84 percent, is for drugs administered particularly drugs and biologicals physician practices and HOPDs that fall incident to a physician’s services. (including biosimilars) used incident to below the threshold from participating Among the ‘‘incident to’’ drugs, over 90 a physician’s services, for example in the model? How could CMS analyze percent of spending is for single source adding additional biologicals use to an appropriate threshold? drugs and biologicals (including • The inclusion of additional Part B treat rheumatoid arthritis and other biosimilars) as defined in section 1847A providers and suppliers that furnish and inflammatory diseases, including of the Act.18 We plan to begin the model bill for any of the model’s included biosimilars if they are marketed. with these two broad groups of drugs drugs as well as the inclusion of The OPPS packages certain drugs both because they encompass most of providers that are paid on a cost basis, with costs below a certain threshold and the Part B spending, and as a result of such as PPS-exempt cancer hospitals, for policy reasons. This model would their status as drugs with a single children’s hospitals, or critical access only include drugs that are separately manufacturer, they allow for a more hospitals. paid under the OPPS, including drugs straightforward comparison to an • The potential approach to selecting on pass-through payment status, and for international pricing metric. Examples geographic areas for the intervention which the drug’s HCPCS code is of included drugs would be cancer and comparison groups in the model. assigned a distinct Ambulatory Payment drugs and adjunct therapy for cancer Are there particular regions of the Classification (APC) group for use when and related conditions, biologicals used country that would need adjustments or the drug is furnished in a HOPD. The for the treatment of rheumatoid arthritis exclusions from the model (for example, model would include any separately and other immune mediated conditions, rural areas)? payable drug or biological furnished in • How should we operationalize the and drugs used to treat macular an HOPD, including any of the HOPD’s model for large provider networks that degeneration. For purposes of the off-campus provider-based departments cover some regions that are included model, we also would include HCPCS (PBDs), regardless of whether those and some that are excluded? codes that contain only products with a PBDs are excepted or nonexcepted • Should class of drugs, physician single manufacturer, even if they are under section 1833(t)(21)(B)(ii) of the specialty, or physician practice determine the payment amount? Are 18 Office of Enterprise Data and Analytics analysis 19 ‘‘Comparison of U.S. and International Prices there other characteristics that should of CMS, Chronic Conditions Data Warehouse, a for Top Medicare Part B Drugs by Total database with 100 percent of Medicare enrollment Expenditures’’ accessed via https://aspe.hhs.gov/ determine the alternative add-on and fee-for-service claims data, available at: http:// pdf-report/comparison-us-and-international-prices- payment amount? ccwdata.org/. top-spending-medicare-part-b-drugs.

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Act, as added by section 603 of the we are concerned that price increases from the vendor, the lead time for the Bipartisan Budget Act of 2015 (Pub. L. among generic drugs are also development of vendors’ acquisition 114–74). contributing to the rising payments for arrangements, and the potential For purposes of included drugs, we Part B drugs. Increasing the number of unavailability of pricing benchmarks for would remove any HCPCS codes that drugs included in the model over time new drugs immediately after a drug is become inactive if they are not replaced could also be accomplished by setting; marketed. by a successor code, and we would not however, drug acquisition and billing Although we are not currently able to include HCPCS codes for which a within Part B settings outside of the estimate exactly what the distribution of product becomes unavailable. If pricing physician office and outpatient hospital drugs over the course of the model may data were available for other heavily may not be conducive to a CAP vendor- look like, Table 1 presents the utilized incident to drugs, we would like approach. percentage of the total allowed Part B consider adding them to the model. We are also considering the best ways charges for 2017 for Part B drugs. Table Over the course of the model, we seek to include newly approved and 1 lists the percentage of the total to include HCPCS codes that encompass marketed drugs in the model. We spending for the following two groups at least 75 percent of allowed charges in anticipate that international pricing data of HCPCS codes: The top 50 drugs by Part B. We note that HCPCS codes for for some but not all of these drugs allowed charges in the office and products that are used across multiple would be available. We include a hospital outpatient departments for settings, such as clotting factors or discussion of the potential alternatives 2017 and the top 100 such drugs. immunoglobulin G, would be included for payments for new therapies in Spending for biologicals (including based on overall Part B use, but the section III.D.5. of this ANPRM. biosimilars), single source drugs, model would only include those drugs We anticipate that newly effective multiple source drugs and potentially when they are administered incident to HCPCS codes could be added to the excluded drugs within each of the three a physician’s service. model on a quarterly or annual basis. groups is also shown. We believe that In addition, we are considering Based on experiences with the CAP, we this information is a reasonable including multiple source drugs and are concerned about issues such as the preliminary estimate of the potential drugs provided in other settings. lag time resulting from the provider scope of this model and its possible Specifically, we are considering having to obtain drugs from regular incorporation of additional Part B drugs including multiple source drugs because channels before the drug is available during the 5-year model duration.

TABLE 1—GROUPS OF DRUGS AS A PERCENTAGE OF TOTAL PART B SPENDING

Single source Multiple source Potential excluded Percentage of Biologicals: drugs: 20 Number of drugs total allowed percentage of total percentage of drugs: drugs: charges allowed charges total allowed percentage of total percentage of total charges allowed charges allowed charges

Top 50 Drugs ...... 81 65 12 0¥<1 4 Top 100 Drugs ...... 94 73 15 1 6

The potential inclusion of a large paid under the authority in section 1881 feasible. Feedback from the perspective subset of Part B drugs should not be of the Act. Finally, we also would of potential model participants and interpreted to mean model participants exclude drugs that are packaged under vendors are especially encouraged. would be required to obtain all products the OPPS when they are furnished by a • The best way to include new drugs that are subject to inclusion from a hospital outpatient department. If these in the model as they become available. specific model vendor. We would drugs met other criteria, they would be • Whether to determine inclusion of anticipate several model vendors to be included in the model when furnished drugs based on on-label (FDA approved) available and that model participants by physician offices. indications only, or whether CMS could enroll with one or more model 4. Requests for Feedback and should consider on-label and off-label vendors. Information use (if supported by clinical guidelines and/or compendia). 3. Potential Excluded Drugs We are seeking information on the We seek comment as to whether following: We are considering excluding the • aspects of mandatory participation Whether the data that CMS uses to would require physicians and hospitals following: drugs that are identified by determine the inclusion of drugs and the FDA to be in short supply (similar to have an agreement with a single biologicals should be limited to claims vendor or would require physicians and to the exclusion from the AMP price from the physician’s office and hospital substitution policy for drugs in short hospitals to obtain all drugs included in outpatient department settings, or the model via a single vendor. supply (77 FR 69141)); and drugs paid whether other settings should be under miscellaneous or ‘‘not otherwise included. D. Model Payment Methodology for classified’’ (NOC) codes, such as J3490, • The drugs to include in the model. Vendor Supplied Drugs due to the operational complexity of Specifically, we are seeking information identifying if drugs paid under the NOC 1. Calculating the Model’s Medicare Part on how to incorporate multiple source B Drug Payment codes are included model drugs. Thus, drugs. compounded drugs would be excluded • Whether to include Part B drugs in The Medicare payment for separately from the model. We also plan to exclude all settings in which they are separately payable Part B drugs is typically based radiopharmaceuticals and ESRD drugs payable or only in certain settings. on ASP of a given Part B drug, plus 6 • Whether quarterly updates for percent of the ASP as an add-on 20 Excluding biologicals. HCPCS codes included in the model are payment. For the potential IPI Model,

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CMS is considering testing an countries that provide drugs through Year Percentage of ASP and target alternative payment for included drugs price public insurance. based on the international pricing, b. CMS Data Collection except where the ASP is lower. CMS Year 1 ...... 80 percent ASP and 20 percent Target Price. would calculate the model payment to We are considering including a data Year 2 ...... 60 percent ASP and 40 percent collection system for manufacturers to model vendors for included drugs Target Price. through a multi-step process. Given report to CMS their international drug Year 3 ...... 40 percent ASP and 60 percent sales data to support the calculation of current estimates of the differential Target Price. the IPI and the Target Price for each between U.S. and international pricing, Year 4 ...... 20 percent ASP and 80 percent drug. We acknowledge that the model payment may be close to Target Price. Year 5 ...... 100 percent Target Price. manufacturers have numerous and parity with international comparators. varying arrangements in other countries Additionally, Manufacturer sales • as well as in the U.S., so we are through the IPI model would be As with current Part B drug considering how we would determine included in current ASP reporting. payments, we would plan to update the the definition of manufacturer to ensure The potential calculation steps would model payment amount for each drug that U.S. manufacturers would robustly include the following: periodically based on new ASP and report this information to CMS. Under international pricing data. • CMS would calculate an average the Medicaid Drug Rebate Program in international price for each Part B drug 2. Data Sources on International Drug section 1927 of the Act, manufacturers Sales included in the model based on a are required to provide information to CMS on a quarterly basis to support the standard unit that is comparable to that CMS is considering including collection of international drug sales ASP calculations (as well as to support in the drug HCPCS code. 23 data for purposes of the IPI Model. In calculations for WAC and AMP ) for • CMS would then calculate the ratio the interim, before these data could be Part B drugs. Using the same framework, of Medicare spending using ASP prices available, CMS is considering relying on for the purposes of the potential IPI for all Part B Drugs included in the existing data sources for calculating the Model, we could require manufacturers model to estimated spending using model payment to model vendors for to provide international drug sales data international prices for the same included drugs. for prices and units sold. number and set of drugs. In order to do We envision that we would require this calculation, CMS would multiply a. Existing Data Sources quarterly reporting on the international Part B volumes by the ASP prices and sales information and CMS would then by the international prices. The CMS has evaluated several existing provide reporting instructions. The data sources to determine the resulting ratio of Medicare spending instructions would include information availability of international drug price under ASP versus Medicare spending such as instructions for the unit level at information. Based on our review, we under the international prices holding which the manufacturer would report believe there are appropriate sources volume and mix of drugs constant the sales information, which countries that could be used for purposes of the would represent the International Price to include and how to account for the potential IPI Model. These data sets Index (IPI). exchange rate, and use of reasonable include those provided by private assumptions. We anticipate that the • CMS would also establish the companies or data obtained through units of measure for the international model Target Price for each drug by review of publicly filed materials by drug sales data would be the same as the multiplying the IPI by a factor that manufacturers in other countries. units in a corresponding drug product’s achieves the model goal of more closely Examples may include IQVIA’s MIDAS HCPCS code. For example, products aligning Medicare payment with dataset, the dataset used in the recent reported in milligrams of drug in the 21 international prices, which would be HHS analysis. Alternatively, CMS can U.S. would be reported in milligrams, about a 30 percent reduction in try to construct price comparisons from and products reported in international Medicare spending for included Part B public sources from each country. One units of biological activity would be drugs over time, and then multiplying example of a public source is the UK’s reported in the same units of that revised index (IPI adjusted for Drug Tariff, which lists the National corresponding biological activity. spending reduction) by the international Health Service (NHS) reimbursement We acknowledge that this potential price for each included drug. CMS rates for prescription drugs.22 We approach could create situations where would calibrate the revised index to believe that existing data sources may very large numbers of units would be account for any drugs with ASP below include all the information necessary to reported, and we seek information on the Target Price. The percentage calculate the IPI and Target Prices. We alternative units of measure to consider. reduction between ASP and Target Price are interested in better understanding We recognize that it would take some would vary for each drug. We would the extent to which existing data time to establish the infrastructure and monitor price changes and recalibrate as sources for international sales reporting instructions to collect and needed. completely capture drug information in validate international sales information every international market that we are • CMS would phase-in the Target directly from manufacturers for considering for inclusion in our Price over the 5 years of the model, as purposes of a model. In light of this, we payment methodology and how private are considering whether existing data a blend of ASP and the Target Price. For market drug sales are included in each calculation, if ASP is lower than sources could be used to establish the the Target Price for an included drug, IPI and Target Price in the short term 21 ‘‘Comparison of U.S. and International Prices the model would set the payment and transition to using manufacturer for Top Medicare Part B Drugs by Total reported data when available. We seek amount to ASP for that drug. Expenditures’’ accessed via https://aspe.hhs.gov/ pdf-report/comparison-us-and-international-prices- comment on the potential use of The potential phase-in would use the top-spending-medicare-part-b-drugs. following blend of ASP and Target 22 See https://www.nhsbsa.nhs.uk/pharmacies- 23 WAC means wholesaler acquisition cost and Price: gp-practices-and-appliance-contractors/drug-tariff. AMP means average manufacturer price.

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existing data sources and new data or other issues associated with be the schedule for phasing down to the sources to establish the IPI and the capturing international sales target savings amount? Target Price. information. In the absence of • How would such a change in international pricing data, CMS could payment policy, as described in this 3. Frequency of Data and Model still calculate a model payment amount section, affect incentives in the market? Payment Updates by applying a standard factor. CMS How could using international reference We are considering examining the IPI could, for example, assume the same pricing affect innovation incentives in and model payments on a quarterly ratio for the new drug as the IPI, which the biopharmaceutical market? basis, on the same schedule and using would be the average volume-weighted the same quarterly sales period duration E. Potential Foreign Market payment amount across all Part B drugs Considerations as ASP data. We believe that we could included in the model. We seek use quarterly updates of existing data comment on options for calculating the Using international sales data in the sources in the short term while we set model payment for new drugs that may potential IPI Model could raise up the infrastructure to collect and not yet have international sales. considerations for drug prices, drug validate international drug sales availability, and sales data in foreign information from the manufacturers on 6. Requests for Feedback and markets. For example, manufacturers a quarterly basis (the data would be Information may seek to raise prices or limit foreign reported to CMS within 30 days of the We welcome input from stakeholders sales. However, existing, multiyear close of the quarter). We seek comment on the potential approach for pricing relationships in foreign markets on whether to examine the international establishing model payments for may minimize this response. There are pricing data, and recalculate the IPI and included drugs based on international also potential model implications in Target Prices on a quarterly, annual or pricing. For example: considering manufacturers’ responses in other basis. We also seek feedback on • What sources of international foreign markets. For example, there may the mechanism for reporting of pricing data capture drug information be a decrease or lack of international international sales, and on any for the international markets that should sales to serve as inputs to the model’s additional requirements that would be be included in our payment IPI calculation, if manufacturers needed to ensure a feasible process to methodology? withdraw or do not launch included collect valid international sales • Are there particular data sources to drugs in foreign markets. Similarly, information for the countries that would establish payment amounts based on manufacturers may also adjust their be included in the IPI, as discussed in international pricing that would best product launch strategies within the the following section of this ANPRM. support this effort? U.S. We also seek comment on ways to • How should private market drug Requests for feedback and ensure confidentiality of reporting of sales included in countries that provide information: international drug pricing to CMS. drugs through public insurance be • CMS welcomes input from 4. Potential Included Countries included? How should CMS protect stakeholders on the potential manufacturer reported international considerations related to foreign We are considering using pricing data pricing information? markets and the potential model from the following countries: Austria, • What is the appropriate frequency payment approach that would rely on Belgium, Canada, Czech Republic, for updating the international pricing international sales data. For example the Denmark, Finland, France, Germany, information that we use in calculating following: Greece, Ireland, Italy, Japan, the Part B payment under the model? • What foreign market considerations Netherlands, and the United Kingdom. • How should manufacturers report should CMS consider in developing the We are considering including these international pricing information? Are potential IPI Model? countries as they are either economies there specific issues with data reporting • How should CMS monitor for comparable to the United States or they processes that stakeholders would like changes in foreign markets that could are included in Germany’s market the agency to consider, especially impact the IPI Model? basket for reference pricing for their mechanisms that could reduce burden? • What are ways to address changes drug prices, and existing data sources • How should we define in foreign sales that could impact model contain pricing information for these manufacturer to ensure that all relevant payment calculations? countries. Some of the countries above entities that sell single source drug have far lower per-capita incomes than products, biologics, biosimilars and, if F. Beneficiary Impact and Model the U.S. However, these countries were applicable, multiple source drugs report Monitoring not consistently the lowest-priced under the model? In addition to existing beneficiary countries according to the HHS • Are there areas of concern in data protections, we would plan to actively analysis.24 We seek comment on the collection and reporting that could lead monitor the IPI Model test to ensure it countries included in our analysis to to inaccurate price calculations? is operating effectively and meeting the establish the IPI, Target Price, and • Which countries should be needs of beneficiaries, health care model payment amounts. included in our international price providers, and the Medicare program. index calculations? Should the 5. Establishing Model Payments for New 1. Impact on Beneficiary Cost-Sharing Drugs Entering the Market countries vary? What characteristics should CMS consider to analyze these We would expect beneficiary cost- For newly approved and marketed countries? sharing for included drugs under the Part B drugs that would be included in • Are there specific considerations in potential IPI Model would either be the the model, there could be some time lag the comparison of international and same or lower than the non-model cost- ASP prices that CMS should address? sharing. Medicare payment policy for 24 ‘‘Comparison of U.S. and International Prices • How should CMS standardize data beneficiary cost-sharing would remain for Top Medicare Part B Drugs by Total the same but since the IPI Model should Expenditures’’ accessed via https://aspe.hhs.gov/ collection and reporting? What should pdf-report/comparison-us-and-international-prices- be the target reduction to ASP payment reduce Medicare payment for some Part top-spending-medicare-part-b-drugs. (that is, Target Price), and what should B drugs, the 20 percent beneficiary

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coinsurance would be similarly We are inviting public feedback on 1. Impact on ‘‘Best Price’’ proportionately reduced. For those the appropriate beneficiary outcomes to Since the model payments to model beneficiaries dually eligible for monitor and how to monitor and vendors for drugs is a Medicare Medicare and Medicaid, the measure such outcomes, as well as payment and it is not a ‘‘price available coinsurance paid for by the beneficiary patient experience, in a way that from the manufacturer,’’ the model or state would similarly be reduced. If minimizes burden on included health payment amounts would not be the Part B payment remains unchanged care providers and beneficiaries. included in the manufacturer’s under the IPI Model, for example, for determination of best price. However, G. Interaction With Other Models those drugs where Medicare payment is since the model payment amounts similar to international prices, cost- In designing each Innovation Center would drive manufacturer drug prices sharing would remain the same. down, the model may impact a To minimize impact on beneficiaries, model, CMS considers potential overlap between a new model and other ongoing manufacturer’s best price. In order for their health care provider would model vendors to purchase included continue to collect cost-sharing for and potential models and programs. Based on the type of overlap, such as drugs in the U.S. at prices that would included drugs. not lead to financial loss, the prices provider or beneficiary, operating rules available from the manufacturer would 2. Medicare Ombudsman are established for whether or not need to be competitive with the model We plan to coordinate with the providers and beneficiaries can be part Medicare Beneficiary Ombudsman to payments. Therefore, such manufacturer of both models as well as how to handle sales to the model vendors could ensure that any Model-related overlap when it is allowed to occur. beneficiary complaints, grievances, or potentially lower best price and These policies help to ensure that the potentially increase Medicaid rebates. requests for information submitted evaluation of model impact is not would be responded to in a timely Medicaid programs could benefit. compromised by issues of model Specifically, if the manufacturer manner. overlap and that the calculation of lowers prices available to a model 3. Monitoring Medicare savings is not overestimated vendor at or below the model payment Consistent with other Innovation due to double counting of beneficiaries rate, such prices would be considered in Center Models, we would also and dollars across different models. In the manufacturer’s determination of best implement a monitoring program for the this vein, CMS has begun to review price and may reset the manufacturer’s IPI Model to ensure the model is which models would have significant best price. This is particularly possible meeting the needs of Medicare overlap with the potential IPI Model. because the model payment amount beneficiaries, health care providers and One example is the Oncology Care includes the impact of sales outside of the Medicare program. These Model (OCM) which runs through mid- the U.S., which are typically lower than monitoring activities would enable CMS 2021. The OCM would require new prices in the U.S., while a to access timely information about the policies that address model overlap due manufacturer’s best price represents effects of the Model on beneficiaries, to the potential inclusion of some of prices available only to purchasers in providers, suppliers, and on the OCM’s initiating cancer therapies in the the U.S. We seek public comments on Medicare program and to facilitate real IPI Model and the probable overlap of how manufacturers would respond to time identification and response to some geographic areas with OCM these factors as they relate to model potential issues. We envision using practices included in the IPI Model. The vendors and Medicaid drug rebates. Medicare claims and other available IPI Model would potentially overlap 2. Impact on Average Manufacturer program data to analyze and monitor the with other Innovation Center models Price (AMP) Model’s implementation, including that operate in the same geographic Similarly, the model payment actively looking at real-time data to areas and include Part B drug spending amounts to model vendors would not be identify potential impacts on in the calculation of model payments, part of the AMP determination. AMP is beneficiaries, health care providers, incentive payments or shared savings, defined at section 1927(k)(1) of the Act. model vendors, and the Medicare and the Medicare Shared Savings Generally, AMP is determined based on program. We would use these findings Programs. We plan to carefully explore the average price paid to the to inform Model oversight and the these potential overlaps and consider manufacturer for a drug in the U.S. by potential need for action to address ways address overlap issues as we wholesalers and retail community findings. further develop the IPI Model. pharmacies with certain exclusions. The As an example, CMS may conduct AMP for a Part B drug will likely be real-time analyses of claims and H. Interaction With Other Federal determined using the AMP computation administrative data, such as monthly Programs for 5i drugs,25 which would include updates and historic comparisons of With respect to single source or sales that are not generally dispensed trends, including ensuring appropriate through retail community pharmacies drug utilization and program spending, innovator multiple source drugs (which Medicaid recognizes to include (see 42 CFR 447.504(d)), such as sales to as well as changes in site-of-service physicians, pharmacy benefit managers biologicals and biosimilars), the term delivery, mortality, hospital admissions, (PBMs) and hospitals. In this case, it is ‘‘Medicaid Best Price’’ is the lowest and other indicators present in claims likely the manufacturer’s sale to a model price available from the manufacturer and administrative data to identify any vendor (or price paid) that would be potential issues related to access and during the rebate period to any included in the AMP or 5i AMP and due utilization. CMS would also consider wholesaler, retailer, provider, health to the downstream effects of the model how to best understand beneficiary maintenance organization, non-profit payment approach, may lower AMP. If experience in the model. We would entity or governmental entity within the the AMP is lower, it may result in consider surveys but would also be U.S. with certain exclusions. We seek potentially lowering the Medicaid drug interested in other potential strategies to comment on how to avoid unintended include beneficiary experience in our consequences on the interaction of the 25 Inhalation, infusion, instilled, implanted or monitoring activities. IPI Model with other federal programs. injectable drugs.

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rebate paid to states (the rebate, in part, reflect national priorities for quality maintaining the quality of beneficiaries’ is based on a percentage of AMP), improvement and patient-centered care care as we implement and test this although the rebate would also be consistent with the measures described potential model. affected because ‘‘best price’’ may be in section 1890(b)(7)(B) of the Act, to • Section 1833(t) of the Act and 42 lower as described above. the extent feasible. To this end, we are CFR 419.64 related to Medicare We continue to consider how the interested in several categories of payment amounts for drugs and model may impact the Medicaid measures, specifically: patient biologicals under the OPPS as necessary program. Authority for implementing experience measures, medication to permit testing of a modified payment innovative payment and quality models management measures, medication amount for included drugs using the under 1115A of the Act does not adherence, and measures related to pricing approaches described in this completely include Title XIX waiver access and utilization. section; authority, and thus, such waiver We are sensitive to concerns regarding • Section 1847A of the Act and 42 authority does not extend to the adding administrative burden to model CFR 414.904 and 414.802 related to use Medicaid Drug Rebate Program, which participants. Some models (for example, of ASP+6 percent and WAC as is authorized under Title XIX at section the Bundled Payments for Care necessary to permit testing of a modified 1927 of the Act. We welcome public Improvement Advanced Model) are payment using the pricing approaches feedback, including from State Medicaid currently structured to include quality described in this paper. programs, on this issue. measures that are calculated directly by • Section 1847B of the Act and 42 CMS or collected during the evaluation CFR 414.906 through 414.920 related to 3. Interaction With 340B Program and do not require the submission of the Medicare Part B Drug Competitive The Health Resources and Services additional data by providers and Acquisition Program (CAP) Administration (HRSA) administers the suppliers. We are considering following requirements as necessary to permit 340B Drug Pricing Program that allows this approach, to the extent feasible, and testing using a CAP-like approach for certain hospitals and other health care to assess the quality of care for purposes the acquisition of included therapies providers (‘‘covered entities’’) to obtain of real-time monitoring of utilization, through vendor-administered payment discounted prices on ‘‘covered hospitalization, mortality, shifts in site- arrangements. outpatient drugs’’ (as defined at of-service and other important • Other requirements under title 1927(k)(2) of the Act) from drug indicators of patient access and XVIII of the Act as may be necessary manufacturers. HRSA calculates a 340B outcomes, without requiring providers solely to test separate payment for ceiling price for each covered outpatient or suppliers to report additional data. included therapies furnished to drug, which represents the maximum We seek information on the categories included beneficiaries by participant price a manufacturer can charge a and types of quality measures CMS can health care providers not paid under the covered entity for the drug. Several incorporate in the model that are outpatient prospective payment system types of hospitals as well as clinics that targeted and judicious, while still or section 1847A of the Act. receive certain federal grants from the capturing key indicators of patient K. Model Termination HHS may enroll in the 340B program as experience, access, and medication covered entities. Such entities located in management. We welcome CMS may terminate the potential IPI the selected model geographic areas recommendations for specific measures. Model for reasons including, but not limited to, the following: CMS would be included in the IPI Model and J. Legal Considerations and Potential determines that it no longer has the would be supplied included drugs for Waivers of Medicare Program funds to support the Model; or CMS included beneficiaries through a model Requirements for Purposes of Testing terminates the Model in accordance vendor. the Model with section 1115A(b)(3)(B) of the Act. 4. Impact on 340B Ceiling Price We plan to test the potential IPI L. Model Evaluation Covered entities that enroll in the Model under the authority of section 340B Program can purchase drugs at no 1115A of the Act and to waive certain Models operated under section 1115A more than a ‘‘ceiling price’’, which are Medicare program requirements as of the Act are required to have an calculated based on a drug’s AMP net necessary solely for purposes of testing evaluation that must include an analysis the Medicaid unit rebate amount. Since the potential model. Under section of the quality of care furnished under the Medicaid unit rebate amount is 1115A(d)(1) of the Act, the Secretary of the model and the changes in spending based partly on AMP minus best price, Health and Human Services may waive by reason of the model. The evaluation to the extent the potential model affects the requirements of Titles XI and XVIII of the model would help inform the a drug’s AMP and best price, the 340B and of sections 1902(a)(1), 1902(a)(13), Secretary and policymakers whether prices would be affected. 1903(m)(2)(A)(iii), and 1934 of the Act this model, as designed, reduces (other than subsections (b)(1)(A) and program expenditures while I. Quality Measures (c)(5) of such section) as may be maintaining or improving the quality of Congress created the Innovation necessary solely for purposes of carrying care furnished to Medicare Center for the purpose of testing out section 1115A of the Act with beneficiaries. innovative payment and service respect to testing models described in Whenever feasible, a comparison delivery models that are expected to section 1115A(b) of the Act. group composed of entities similar to reduce program expenditures while We plan to waive requirements of the the model participants but not exposed preserving or enhancing the quality of following provisions as may be to the model is used to determine the care for Medicare beneficiaries. In the necessary solely for purposes of testing model impact. In this particular IPI Model, we are considering collecting the Model. The purpose of this potential model, intervention and quality measures to help us better flexibility would be to allow Medicare comparison groups would be understand the impact of this model on to test approaches described in the determined through a random selection beneficiary access and quality of care. ‘‘Model Payment Methodology’’ section, or assignment process. A randomized We intend to identify quality measures with the goal of reducing Medicare design helps minimize the impact of to be collected as part of this model that expenditures while improving or unmeasurable factors that may

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contribute to providers’ and suppliers’ M. Potential Impacts of Implementing additional analysis. As such, the likelihood to participate in the model. the IPI Model estimates shown below should be Our inability to control for these 1. Financial Impacts considered an approximate measure of unobserved differences could lead to the potential savings of the potential biased or incorrect estimates in the This section outlines the potential model, and subsequent analyses would evaluation of the model’s impact on financial impact of implementing the likely be materially different from those potential IPI Model on federal Medicare quality of care and spending. We note shown below as additional information and Medicaid spending. There are many that to the extent that model sales affect becomes available. uncertainties around estimating the the overall ASP calculation, we may financial effects of this model. In a. Medicare and Dual Medicare- experience evaluation challenges with addition to the various policy Medicaid Impacts the comparison group geographic areas parameters that are either currently not selected for the model. unspecified or subject to change The following table presents the We seek input on the evaluation throughout the policy development potential financial impact of the model. approach to examine the IPI Model’s process, the expected change in For 2020–25, federal Medicare spending impact on Medicare spending and beneficiary, provider, vendor, and is estimated to be reduced by $16.3 quality of care including potential manufacturer behavior would billion and Medicaid spending for alternatives. significantly affect the financial impact Medicare-Medicaid dual beneficiaries is of the model. The current analysis of expected to be reduced by $1.6 billion, this model reflects many generalized of which $0.9 billion is reduced federal assumptions that are likely to change spending and $0.7 billion is reduced pending further policy development and State spending.

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Note the following: burden that are not covered under the reopening of the public comment period • No changes in utilization are provisions in section 1115A(d)(3) of the on the August 6, 2008, proposed rule to assumed in this analysis. Act 26 or otherwise covered under a PRA remove the Hawaiian hawk or io (Buteo • Medicare Advantage spending exemption, a detailed discussion of the solitarius) from the List of Endangered would be reduced proportionately to the requirements and burden will be and Threatened Wildlife (List) under the reduction in FFS spending. submitted to OMB for approval. In Endangered Species Act of 1973, as • Included drugs would represent 61 accordance with the implementing amended (Act). Comments submitted percent of Part B allowed drug spending regulations of the PRA at 5 CFR 1320.11, during the 2008 comment period, 2009 in years 1 and 2, 81 percent of Part B interested parties will also be provided reopened comment periods, and 2014 allowed drug spending in years 3 and 4, an opportunity to comment on such reopened comment period do not need and 94 percent of allowed drug information through subsequent to be resubmitted, and will be fully spending in year 5. proposed and final rulemaking considered in preparation of our final • The Medicaid impact represents the documents. rule. We are reopening the comment portion of Medicare cost-sharing that is period once more to present information V. Response to Comments paid on behalf of dual beneficiaries. It we have received since 2014 that is is estimated based on the change in Because of the large number of public relevant to our consideration of the Medicare cost-sharing and current dual comments we normally receive on status of the Hawaiian hawk. We beneficiary enrollment. No assumptions Federal Register documents, we are not encourage those who may have are made for State price limitations that able to acknowledge or respond to them commented previously to submit would limit the beneficiary cost-sharing individually. We will review all additional comments, if appropriate, in paid for by Medicaid. comments we receive by the date and light of this new information. In • Effects on private market cannot be time specified in the DATES section of addition, we are also seeking input on estimated at this time and are not this preamble, as we continue to considerations for post-delisting reflected in this analysis. consider the model presented in this monitoring of the Hawaiian hawk. Our b. Medicaid Impacts ANPRM. goal is to respond to comments and In accordance with the provisions of come to a final determination on the Based on a review of the Part B drugs Executive Order 12866, this ANPRM status of the Hawaiian hawk in the form that constituted the majority of Part B was reviewed by the Office of of a final rule by the end of 2018. drug spending in 2017, as well as the Management and Budget. top reported Medicaid drugs that were DATES: The comment period for the also covered by Part B, the affected Dated: October 25, 2018. proposed rule published August 6, drugs reimbursed by Medicaid spending Seema Verma, 2008, at 73 FR 45680 is reopened. To totaled at least $4 billion in 2017, or an Administrator, Centers for Medicare & ensure that we are able to consider your estimated 6 percent of gross Medicaid Medicaid Services. comments and information, they must drug spending. The model may impact Dated: October 25, 2018. be received or postmarked no later than November 29, 2018. Please note that, if AMP, ASP, best price, and 340B pricing Alex M. Azar II, for these affected drugs, reducing both you are using the Federal eRulemaking Secretary, Department of Health and Human Portal (see ADDRESSES, below), the reimbursements as well as rebates. CMS Services. would seek comment on whether we deadline for submitting an electronic [FR Doc. 2018–23688 Filed 10–25–18; 4:15 pm] comment is 11:59 p.m. Eastern Time on should exempt prices offered under the BILLING CODE 4120–01–P model from AMP and Best Price this date. We may not be able to address calculations. or incorporate information that we receive after the above requested date. 2. Potential Impacts on Medicare DEPARTMENT OF THE INTERIOR ADDRESSES: You may submit comments Providers and Suppliers Participating in Fish and Wildlife Service by one of the following methods: the Potential IPI Model (1) Electronically: Go to the Federal The potential IPI Model would affect 50 CFR Part 17 eRulemaking Portal: http:// a significant number of health care www.regulations.gov. In the Search box, providers that would furnish included [Docket No. FWS–R1–ES–2007–0024; enter FWS–R1–ES–2007–0024, which is drugs to included Medicare FXES11130900000C6–189–FF09E42000] the docket number for this rulemaking. beneficiaries. The effect of the model on RIN 1018–AU96 Then, click on the Search button. On the individual hospitals, physicians, resulting page, in the Search panel on practitioners, and other providers and Endangered and Threatened Wildlife the left side of the screen, under the suppliers would depend on individual and Plants; Removing the Hawaiian Document Type heading, click on the practice patterns and the drugs that Hawk From the Federal List of Proposed Rule box to locate this would be selected for inclusion. Endangered and Threatened Wildlife document. You may submit a comment by clicking on ‘‘Comment Now!’’ Please IV. Collection of Information AGENCY: Fish and Wildlife Service, ensure that you have found the correct Requirements Interior. rulemaking before submitting your This ANPRM is a general solicitation ACTION: Proposed rule; document comment. of comments on several options availability and reopening of comment (2) By hard copy: Submit by U.S. mail pertaining to the potential IPI Model period. or hand-delivery to: Public Comments and thereby not subject to OMB review Processing, Attn: FWS–R1–ES–2007– as stated in the implementing SUMMARY: We, the U.S. Fish and 0024, U.S. Fish and Wildlife Service, regulations of the Paperwork Reduction Wildlife Service (Service), announce the MS: BPHC, 5275 Leesburg Pike, Falls Act (PRA) of 1995 (44 U.S.C. 3501 et Church, VA 22041–3808. 26 As stated in section 1115A(d)(3) of the Act, seq.) at 5 CFR 1320.3(h)(4). Should the Chapter 35 of title 44, U.S.C., shall not apply to the We request that you send comments outcome of the ANPRM result in any testing and evaluation of models under section only by the methods described above. information collection requirements or 1115A of the Act We will post all comments on http://

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www.regulations.gov. This generally recent publications, and further Kerr 2018, pers. comm.). Currently, the means that we will post any personal evaluation of existing information. insect is established and reproducing on information you provide us (see Public Information pertaining to the status of strawberry guava at multiple forest sites Comments, below, for more the species that has become available to on five islands (Hawaii, Kauai, Lanai, information). us since the 2014 notice is provided Maui, and Oahu) (Chaney and Johnson Document availability: The 2008 below. 2018, in litt.). Under favorable conditions, Tectococcus populations proposed delisting of the Hawaiian New Information hawk, comments received during all the have increased rapidly and spread 33 to open comment periods, and the draft Since the 2014 notice to reopen the 262 feet (10 to 80 meters) in a period of post-delisting monitoring plan (draft comment period, we received updated several months (Chaney and Johnson PDM plan) are available on http:// information on trends in human 2018, in litt.). The scale typically www.regulations.gov. In addition, the population growth, urbanization, and weakens the trees through its feeding, supporting file for this proposed rule land subdivision; biocontrol efforts for reducing the ability of the tree to fruit will be available for public inspection, strawberry guava; impacts from ROD and set seed, thereby limiting its spread by appointment, during normal business and climate change; and recent volcanic (U.S. Forest Service 2016, in litt.). The hours, at the Pacific Islands Fish and activity. We have also received some scale is not expected to kill already Wildlife Office, 300 Ala Moana preliminary data from an in-house established trees (Hawaii Department of Boulevard, Room 3–122, Honolulu, HI population viability assessment (PVA) Agriculture 2011, in litt.). It is too early 96850; telephone 808–792–9400. (Vorsino and Nelson 2016, unpublished to know what effect this may have on data). In addition, we are not aware of FOR FURTHER INFORMATION CONTACT: guava tree vigor and rate of spread; any changes in the status of the biofuel Mary Abrams, Field Supervisor, however, infestations of Tectococcus are crop production or processing facility expected to spread gradually on the telephone: 808–792–9400. Direct all on the island since 2014 that would questions or requests for additional target plant, reaching damaging levels impact the status of the Hawaiian hawk. within a few years at each release site information to: U.S. Fish and Wildlife Although trends in urban and exurban Service, Pacific Islands Fish and (Kerr 2018, pers. comm.). The Forest growth, and land subdivision show Service will continue to provide Wildlife Office, 300 Ala Moana upward movement, the rate of growth Boulevard, Room 3–122, Honolulu, HI technical assistance and monitor the has slowed. Population growth for impacts of biocontrol. It is expected that 96850. Persons who use a Hawaii County between 2010 and 2017 telecommunications device for the deaf a noticeable decrease in the spread of was 1.1 percent annually, 0.5 percent strawberry guava will be observed over (TDD) may call the Federal Relay lower than the 1.6 projection in 2012 a period of years (Kerr 2018, pers. Service at 800–877–8339. (Hawaii Department of Business, comm.). SUPPLEMENTARY INFORMATION: Economic Development and Tourism Hawaiian hawks frequently nest in Species Information and Previous (HDBEDT) 2018, in litt.). The number of native ohia (Metrosideros polymorpha), Federal Actions new homes built per year has also an evergreen tree in the myrtle family. decreased (County of Hawaii 2015, p. In 2013, landowners in lower Puna On August 6, 2008, we published a 146). Most urban and exurban growth is District noticed an increased rate of proposed rule to delist the Hawaiian occurring in or adjacent to already what was thought to be ohia dieback hawk (io) (73 FR 45680). Please refer to developed areas (County of Hawaii (Friday and Friday 2013, entire), a that proposed rule and the recovery 2015, p. 77, 150). We expect residential phenomenon where trees affected show plan (which can be found at: http:// and exurban construction for Hawaii progressive dieback accompanied by _ ecos.fws.gov/docs/recovery plan/ County to continue at a similar pace in browning of the leaves, reduction in leaf 840509.pdf) for information about the the foreseeable future as indicated by size, and death of all or part of the Hawaiian hawk, its status, its threats, expected human population growth for crown (Hodges et al. 1986, p. ii.). and a summary of factors affecting the Hawaii County and home construction Although ohia dieback may have been species. Please refer to our February 12, for the island of Hawaii for the last three the culprit of some of the observed 2014, notice to reopen the comment decades (County of Hawaii 2010, tables dieback leading up to the 2013 report period for a summary of all previous 16.1–16.13; County of Hawaii 2015, pp. (Friday and Friday 2013, entire), we Federal actions (79 FR 8413). 144–146, 149–150; HDBEDT 2018, in now believe that at least some of this Since the 2008 proposed rule, we litt.). Urban and exurban growth and dieback was actually caused by ROD. In opened three additional comment subdivisions in Puna may slow even addition to the other information we periods. During these comment periods, more due to the recent volcanic activity request in Public Comments, below, we we received new or updated of Kilauea, which began in May 2018. request new information on ROD and its information on projected urban growth The north Kona region has one of the potential or actual impact on Hawaiian rates and conversion of agriculture highest urban and exurban growth rates hawk. lands to unsuitable Hawaiian hawk on the island (County of Hawaii 2015, Although new information shows habitat; and potential effects of climate p. 11), as well as one of the highest negative habitat trends due to change (e.g., increased frequency or densities of Hawaiian hawk (Gorresen et urbanization, nonnative plant species prolonged drought), rapid ohia death al. 2008, p. 42). invasion, and ROD, efforts at habitat (ROD), and invasive plants (e.g., Since the successful deployment in restoration that benefit the Hawaiian Psidium cattleianum (strawberry 2012 of a biocontrol agent for strawberry hawk are being implemented and are guava)) on Hawaiian hawk habitat. The guava (the Brazilian scale insect, achieving success. majority of relevant information that has Tectococcus ovatus) during field trials, Both State and private foresters report become available since our 2008 the State of Hawaii and other partners an increase in forest areas on the island proposal to delist the Hawaiian hawk have been working to establish of Hawaii, particularly in native forest comes from over 173 public comments, Tectococcus on strawberry guava areas (Koch and Walter 2018, in litt.). 4 independent peer reviews, comments invaded forests throughout the islands Starting at the turn of the century, from the State of Hawaii and county (Chaney and Johnson in HCC 2013, p. several large landowners (private, agencies and the National Park Service, 74; Chaney and Johnson 2018, in litt.; Federal, and State) have ended their

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pastoral leases and are steadily hawp.org/). This value is likely an species) are implemented by, but not promoting natural regeneration to take underestimate as there are so many limited to, the Nahelehele Dryland the place of old pastures (Koch and partners conducting restoration Forest Restoration program (http:// Walter 2018, in litt.). While we know activities that it is difficult to know www.drylandforest.org/), partnerships this conversion is occurring, we do not exactly how many acres are being working in the Puu Waawaa watershed have an exact number of acreage. managed by each entity. Additional (e.g., the multi-agency Hawaii Additionally, when economically activities implemented by the three Experimental Tropical Forest (http:// feasible, many nonnative timber watershed partnerships on the island of www.hetf.us/page/home/)), The Nature plantations in the State have begun Hawaii include programs that Conservancy’s Kona Hema Preserve planting native timber species, most implement fencing inspections and (https://www.nature.org/ourinitiatives/ often koa (Acacia koa), post-harvest necessary replacements, native species regions/northamerica/unitedstates/ (Koch and Walter 2018, in litt; Walter surveys, greenhouse and plant hawaii/placesweprotect/kona- 2018, pers. comm.). We do not have an propagation, prevention of the spread of hema.xml), Hawaii Volcano’s National exact number regarding this conversion, ROD, and outreach (TMA 2007, p. 41; Park, Hakalau National Wildlife Refuge, but we know it is ongoing. The DLNR 2011, p. 16; State of Hawaii 2012, and the Statewide Sustainable Hawaii suitability of koa plantations for pp. 43–44; State of Hawaii 2017, pp. 1– Initiative (https://governor.hawaii.gov/ Hawaiian hawk foraging and nesting has 6; Cole 2018, in litt.; Dwight 2018, in sustainable-hawaii-initiative/). not been studied, and hawk use of these litt.; Perry 2018, in litt.; http://hawp.org/ Additionally, there are many State areas may be variable, because koa ). Natural Area Reserves and Forest plantations likely differ in their In 2016, the Governor of Hawaii Reserves, and several wildlife suitability as hawk habitat depending initiated the Sustainable Hawaii sanctuaries that provide additional upon age of koa stands, stand density, Initiative (Initiative) in response to the forest areas for Hawaiian hawks and and overstory characteristics related to 2016 World Conservation Congress other native species; however because harvest methods used. A new forest Legacy Commitment to protect 30 hunting is allowed on many of the planting project between Waimea and percent (253,000 ac (102,385 ha)) of Natural Area Reserves and Forest Ahualoa will convert 565 acres (ac) (229 Hawaii’s highest priority watershed Reserves, they are not maintained solely hectares (ha)) of grassland to koa and forests by 2030 (http:// as protected areas for native species koa-ohia forests in the next 10 years governor.hawaii.gov/sustainable- (https://dlnr.hawaii.gov/recreation/ (Koch and Walter 2018, in litt.). hawaii-initiative/). Through this hunting/). As previously mentioned, There has also been a marked increase Initiative, the amount of priority forested areas, particularly native forest in protection of native forests-which watershed areas under high level of areas, are increasing on the island of combined with an increase in forest protection has increased from 10 to Hawaii (Koch and Walter, 2018, in litt.); areas results in increased protection for approximately 15 percent (http:// however we do not have an exact the Hawaiian hawk by protecting governor.hawaii.gov/sustainable- number to quantify this increase. potential nesting, breeding, and hunting hawaii-initiative/; State of Hawaii 2017, At the onset of the most recent habitat. Several large conservation in litt.; https://dashboard.hawaii.gov/ Kilauea volcano eruption (May 2018), efforts across the island are being en/stat/goals/5xhf-begg/4s33-f5iv/wtjm- primarily private lands were impacted; implemented by Federal, State, and 96jt). The Initiative has outplanted however, more recently the ongoing private landowners, often in 20,000 native trees, and increased eruption has impacted native forest collaborative efforts. invasive plant control by 130,000 ac areas. In June 2018, the 1,514 ac (613 Fencing and ungulate removal at Puu (52,609 ha) (State of Hawaii 2017, in ha) Malama Ki Forest Reserve (FR) and Waawaa Forest Bird Sanctuary and parts litt). In addition, the Hawaii Department surrounding areas were either buried by of the State’s Natural Area Reserve of Land and Natural Resources (DLNR), acres of lava or scorched by fumes of System contribute to Hawaiian hawk with funding from the Initiative, sulphur dioxide (Bergfield 2018, in litt.; habitat restoration (Gorresen et al. 2008, constructed 22 miles (35 kilometers) of KHON2 2018, in litt.). This area p. 26) because it helps control the fencing in the Kau watershed, and previously provided habitat for spread of invasive plants such as fenced 24,000 ac (9,712 ha) in the endangered forest birds and plants, and strawberry guava as well as contributes Manuka NAR, to protect these areas other native species. We do not have an toward the natural regeneration of from the negative impacts of pigs and exact number of how much native forest native or native exotic mixed habitat other ungulates (Smith 2013, in litt.; has been, or will be, lost as the eruption which in turn provides potential State of Hawaii 2014, p. 1). These is ongoing. The Kilauea eruption is so nesting, breeding, and foraging measures benefit the Hawaiian hawk by far concentrated to the East Rift Zone opportunities for the hawk. The Kohala securing potential nesting, breeding, area (USGS 2018, in litt.). Watershed Partnership, Mauna Kea and hunting habitat. The island of Hawaii, like the island Watershed Alliance, and TMA, which Over the past 6 years, the Hawaiian chain, has fortunately evaded most collectively encompass approximately Legacy Reforestation Initiative (HLRI) hurricanes due to the surrounding cool 1,688,300 ac (675,137 ha) on Hawaii, has converted 1,000 ac (405 ha) of water. An exception occurred in 2014 have been fencing, outplanting native denuded pastureland into an intact with Hurricane Iselle. Although plants, and removing nonnative species ecosystem with over 300,000 endemic Hurricane Iselle morphed into a tropical since 2003, 2008, and 2009, respectively trees (e.g., ohia, milo (Thespesia storm before making landfall on the (http://hawp.org/). Currently, these populnea), sandalwood (Santalum island, it caused extensive canopy loss entities conduct restoration actions on species), and koa), outplanted and a in some regions of the island (Federal over 80,000 ac (32,374 ha) of forest area plans to outplant approximately 700,000 Emergency Management Agency on Hawaii (TMA 2007, p. 41; Hawaii more endemic trees over the coming (FEMA) 2014, in litt.). Iselle was the Department of Land and Natural years (HLRI 2018, in litt.; https:// strongest tropical storm to make landfall Resources (DLNR) 2011, p. 16; State of legacytrees.org/). on the island of Hawaii in recorded Hawaii 2012, pp. 43–44; State of Hawaii Additional ongoing conservation history. In 2016, Hurricane Darby made 2017, pp. 1–6; Cole 2018, in litt.; Dwight efforts (e.g., nonnative plant and animal landfall on the island of Hawaii but as 2018, in litt.; Perry 2018, in litt.; http:// removal, fencing, and outplanting native a much weaker tropical storm. While

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both of these hurricanes caused canopy The Service has developed a draft of land subdivision and development; loss in some regions of the island, no post-delisting monitoring (PDM) plan effects on native forest of introduced analysis has been done to determine for Hawaiian hawk in cooperation with plant species; conversion of land to impacts to Hawaiian hawk habitat. the State of Hawaii Department of Land biodiesel production, forestry, and Recent data indicate that Hawaii may and Natural Resources, Division of diversified agriculture; and potential experience an increase in hurricane Forestry and Wildlife (DOFAW); the effects of biocontrol efforts on frequency and intensity due to increases National Park Service (NPS); and the strawberry guava; of both ocean surface temperatures and U.S. Geological Survey, Ecosystem (d) Potential effects of temperature El Nin˜ o events associated with a Mission Area (formerly the Biological and rainfall change on fire frequency warming global climate system (Cai et Resources Division). The draft PDM and intensity and forest type and al. 2015, pp. 1, 4–5; Herring et al. 2015, plan includes monitoring the Hawaiian distribution; p. Sii; Knutson et al. 2015, p. 7222; hawk population every 5 years for 20 (e) Potential impacts of ROD and Murakami et al. 2015, p. S118; Wing et years and is designed to verify that the climate change (e.g., increased al. 2015, pp. 8673–8676; Fletcher 2016, Hawaiian hawk remains secure from frequency or prolonged drought); and p. 14). risk of extinction after its removal from (f) Potential impacts of the recent A preliminary female specific the Federal List of Endangered and Kilauea Volcano eruptions. stochastic PVA model for the Hawaiian Threatened Wildlife. While not (2) The factors, as detailed in the hawk was developed (Vorsino and required, with this notice, we are again August 6, 2008, proposed rule (73 FR Nelson 2016, unpublished data) using soliciting public comments and peer 45680), that are the basis for making a the mean and variance values of age- review on the draft PDM plan, which listing/delisting/downlisting specific survival and fecundity (ability can be found on http:// determination for a species under and willingness to produce offpring) in www.regulations.gov at docket number section 4(a) of the Act, which are: native, mixed native-exotic, and exotic FWS–R1–ES–2007–0024. We are (a) The present or threatened habitat (Gorresen et al. 2008, p. 15; particularly interested in monitoring destruction, modification, or Klavitter et al. 2003, p. 170). Population information pertaining to Hawaiian curtailment of its habitat or range; viability was assessed for optimal and hawk habitat in light of ROD and (b) Overutilization for commercial, sub-optimal habitats, where population strawberry guava. All comments on the recreational, scientific, or educational partitioning was based on Hawaiian draft PDM plan from the public and purposes; hawk densities within the habitat types peer reviewers will be considered and (c) Disease or predation; (optimal/sub-optimal) reported in incorporated into the final PDM plan as (d) The inadequacy of existing Gorresen et al. (2008, p. 15). The effect appropriate. regulatory mechanisms; or of catastrophic weather events on the (e) Other natural or manmade factors viability of Hawaiian hawk in these Public Comments affecting its continued existence. various habitat types was also projected We intend that any final action (3) Input or considerations for post- and assessed. None of the projected resulting from the proposal will be delisting monitoring of the Hawaiian PVAs showed a Hawaiian hawk based on the best scientific and hawk. population that declined to either zero, commercial data available and will be as You may submit your information by or below a quasi-extinction threshold of accurate and effective as possible. To one of the methods listed in ADDRESSES. 50 individuals, when projected over 30 ensure our determination is based on If you submit information via http:// years across 500 model iterations. the best available scientific and www.regulations.gov, your entire Current analysis of biodiesel fuel commercial information, we request submission—including any personal development indicates that construction information on the Hawaiian hawk from identifying information—will be posted and testing of facilities on the island of governmental agencies, native Hawaiian on the website. If you submit a Hawaii has plateaued at 2014 levels, groups, the scientific community, hardcopy that includes personal with just one biodiesel facility on the industry, and any other interested identifying information, you may island. In addition to the other parties. We request comments or request at the top of your document that information we request in Public suggestions on our August 6, 2008 (73 we withhold this personal identifying Comments below, we request new FR 45680), proposal to delist the information from public review. information on the actual conversion of Hawaiian hawk; our draft PDM plan; However, we cannot guarantee that we agricultural land to crops for biodiesel new information presented in this will be able to do so. We will post all fuel production, including former and Federal Register document; and any hardcopy submissions on http:// current crop type and acreage. other information. Specifically, we seek www.regulations.gov. Information and supporting Post-Delisting Monitoring Plan information on: (1) The species’ biology, range, and documentation that we receive and use Section 4(g)(1) of the Act requires us, population trends, including: in preparing the proposal will be in cooperation with the States, to (a) Life history, ecology, and habitat available for you to review at http:// implement a monitoring program for not use of the Hawaiian hawk, as well as the www.regulations.gov, or you may make less than 5 years for all species that have species’ use of koa plantations and an appointment during normal business been delisted due to recovery. The exurban areas; hours at the Service’s Pacific Islands purpose of this requirement is to (b) Range, distribution, population Fish and Wildlife Office (see FOR develop a program that detects the size, and population trends; FURTHER INFORMATION CONTACT). failure of any delisted species to sustain (c) Positive and negative effects of If you submitted comments or itself without the protective measures current and foreseeable land information previously on the August 6, provided by the Act. If, at any time management practices on the Hawaiian 2008, proposed rule (73 FR 45680); the during the monitoring period, data hawk, including conservation efforts February 11, 2009, document that made indicate that protective status under the associated with watershed partnerships available our draft PDM plan (74 FR Act should be reinstated, we can initiate (e.g., The Rain Follows the Forest 6853); the June 5, 2009, publication listing procedures, including, if initiative and the Governor’s announcing public hearings and appropriate, emergency listing. Sustainable Hawaii Initiative); patterns reopening the proposal’s and draft PDM

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plan’s comment period (74 FR 27004); www.regulations.gov and upon request Authority or the February 12, 2014, publication from the Service’s Pacific Islands Fish reopening the proposal’s and draft PDM and Wildlife Office (see FOR FURTHER The authority for this action is the plan’s comment period (79 FR 8413), INFORMATION CONTACT). Endangered Species Act of 1973, as please do not resubmit them. These amended (16 U.S.C. 1531 et seq.). Authors comments have been incorporated into Dated: August 14, 2018. the public record and will be fully The primary authors of this document James W. Kurth, considered in the preparation of our are staff of the Service’s Pacific Islands final determination. Deputy Director, U.S. Fish and Wildlife Fish and Wildlife Office (see FOR Service, Exercising the Authority of the References Cited FURTHER INFORMATION CONTACT). Director, U.S. Fish and Wildlife Service. A complete list of references cited is [FR Doc. 2018–23697 Filed 10–29–18; 8:45 am] available on the internet at http:// BILLING CODE 4333–15–P

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Notices Federal Register Vol. 83, No. 210

Tuesday, October 30, 2018

This section of the FEDERAL REGISTER call-in number: 1–877–260–1479 and DEPARTMENT OF COMMERCE contains documents other than rules or conference ID# 6006921. proposed rules that are applicable to the Foreign-Trade Zones Board public. Notices of hearings and investigations, Members of the public are invited to committee meetings, agency decisions and make statements during the open [S–134–2018] rulings, delegations of authority, filing of comment period of the meetings or petitions and applications and agency submit written comments. The Approval of Subzone Status; Digi-Key statements of organization and functions are comments must be received in the Corporation; Thief River Falls, examples of documents appearing in this regional office approximately 30 days Minnesota section. after each scheduled meeting. Written On August 24, 2018, the Executive comments may be mailed to the Secretary of the Foreign-Trade Zones COMMISSION ON CIVIL RIGHTS Midwest Regional Office, U.S. (FTZ) Board docketed an application Commission on Civil Rights, 230 S submitted by the Koochiching Economic Notice of Public Meetings of the New Dearborn Street, Suite 2120, Chicago, IL Development Authority, grantee of FTZ York Advisory Committee 60604, faxed to (312) 353–8324, or 259, requesting subzone status subject to emailed to David Barreras at dbarreras@ the existing activation limit of FTZ 259, AGENCY: Commission on Civil Rights. usccr.gov. Persons who desire on behalf of Digi-Key Corporation, in ACTION: Announcement of meetings. additional information may contact the Thief River Falls, Minnesota. Midwest Regional Office at (312) 353– The application was processed in SUMMARY: Notice is hereby given, 8311. accordance with the FTZ Act and pursuant to the provisions of the rules Regulations, including notice in the Records and documents discussed and regulations of the U.S. Commission Federal Register inviting public on Civil Rights (Commission), and the during the meeting will be available for comment (83 FR 44565–44566, August Federal Advisory Committee Act public viewing as they become available 31, 2018). The FTZ staff examiner (FACA), that a meeting of the New York at https://database.faca.gov/committee/ reviewed the application and Advisory Committee to the Commission meetings.aspx?cid=265; click the determined that it meets the criteria for will convene by conference call at 12:00 ‘‘Meeting Details’’ and ‘‘Documents’’ approval. Pursuant to the authority p.m. (EDT) on: Friday, November 9, links. Records generated from this delegated to the FTZ Board Executive 2018. The purpose of the meeting is to meeting may also be inspected and Secretary (15 CFR Sec. 400.36(f)), the discuss topics of study. reproduced at the Eastern Regional application to establish Subzone 259B DATES: Friday, November 9, 2018 at Office, as they become available, both was approved on October 25, 2018, 12:00 p.m. EDT before and after the meetings. Persons subject to the FTZ Act and the Board’s Public Call-In Information: interested in the work of this advisory regulations, including Section 400.13, Conference call-in number: 1–877–260– committee are advised to go to the and further subject to FTZ 259’s 2,000- 1479 and conference ID# 6006921. Commission’s website, www.usccr.gov, acre activation limit. FOR FURTHER INFORMATION CONTACT: or to contact the Midwest Regional Dated: October 25, 2018. David Barreras, at [email protected] Office at the above phone numbers, Andrew McGilvray, or by phone at 312–353–8311. email or street address. Executive Secretary. SUPPLEMENTARY INFORMATION: Interested Agenda [FR Doc. 2018–23662 Filed 10–29–18; 8:45 am] members of the public may listen to the BILLING CODE 3510–DS–P discussion by calling the following toll- Friday, November 9, 2018 free conference call-in number: 1–877– • 260–1479 and conference ID# 6006921. Open—Roll Call DEPARTMENT OF COMMERCE Please be advised that before placing • Discussion of Study Topics them into the conference call, the • Open Comment International Trade Administration conference call operator will ask callers to provide their names, their • Adjourn [C–570–980] organizational affiliations (if any), and Exceptional Circumstance: Pursuant Crystalline Silicon Photovoltaic Cells, email addresses (so that callers may be to 41 CFR 102–3.150, the notice for this Whether or Not Assembled Into notified of future meetings). Callers can meeting is given less than 15 calendar Modules, From the People’s Republic expect to incur charges for calls they days prior to the meeting because of the of China: Amended Final Results of initiate over wireless lines, and the exceptional circumstance of the Countervailing Duty Administrative Commission will not refund any rescheduling of a previously cancelled Review; 2015 incurred charges. Callers will incur no meeting. charge for calls they initiate over land- AGENCY: Enforcement and Compliance, line connections to the toll-free Dated: October 24, 2018. International Trade Administration, conference call-in number. David Mussatt, Department of Commerce. Persons with hearing impairments Supervisory Chief, Regional Programs Unit. SUMMARY: The Department of Commerce may also follow the discussion by first [FR Doc. 2018–23605 Filed 10–29–18; 8:45 am] (Commerce) is amending the final calling the Federal Relay Service at 1– BILLING CODE P results of the countervailing duty 800–977–8339 and providing the administrative review of crystalline operator with the toll-free conference silicon photovoltaic cells, whether or

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not assembled into modules (solar cells, and modules, laminates, and Amended Final Results cells), from the People’s Republic of panels, consisting of crystalline silicon As a result of correcting the China (China) to correct a ministerial photovoltaic cells, whether or not ministerial error, we determine the error. partially or fully assembled into other countervailable subsidy rates for the DATES: Applicable October 30, 2018. products, including, but not limited to, producers/exporters under review to be modules, laminates, panels and building FOR FURTHER INFORMATION CONTACT: as follows: integrated materials. Merchandise Gene H. Calvert, AD/CVD Operations, covered by this order is currently Office VII, Enforcement and Subsidy rate classified in the Harmonized Tariff Producer/exporter (percent ad Compliance, International Trade Schedule of the United States (HTSUS) valorem) Administration, U.S. Department of Commerce, 1401 Constitution Avenue under subheadings 8501.61.0000, Canadian Solar and its NW, Washington, DC 20230; telephone 8507.20.80, 8541.40.6020, 8541.40.6030, Cross-Owned Affiliates 7 ... 11.59 (202) 482–3586. and 8501.31.8000. These HTSUS Trina Solar and its Cross- subheadings are provided for Owned Affiliates 8 ...... 9.12 SUPPLEMENTARY INFORMATION: convenience and customs purposes; the Background written description of the scope of this Review-Specific Average Rate Applicable to the Non-Selected In accordance with section 751(a)(1) order is dispositive. A full description Companies Subject to this Review: of the Tariff Act of 1930, as amended of the scope of the order is contained in (the Act), and 19 CFR 351.221(b)(5), on the Final Results Decision Memorandum.4 Subsidy rate July 23, 2018, Commerce published its Producer/exporter (percent ad final results in the administrative Ministerial Errors valorem) review of the countervailing duty order on solar cells from China for the period Section 751(h) of the Act and 19 CFR Baoding Jiasheng Photo- voltaic Technology Co., of review (POR) January 1, 2015, 351.224(f) define a ‘‘ministerial error’’ as 1 Ltd...... 10.64 through December 31, 2015. On August an error in addition, subtraction, or Baoding Tianwei Yingli New 2, 2018, Canadian Solar Inc. (Canadian other arithmetic function, clerical error Energy Resources Co., Solar), a respondent in this resulting from inaccurate copying, Ltd...... 10.64 administrative review, submitted timely duplication, or the like, and any other Beijing Tianneng Yingli New ministerial error allegations concerning similar type of unintentional error Energy Resources Co., the Final Results.2 On August 7, 2018, which the Secretary considers Ltd...... 10.64 SolarWorld Americas, Inc. timely filed ministerial. Commerce finds that an Canadian Solar International, rebuttal comments to Canadian Solar’s error alleged by Canadian Solar Ltd...... 10.64 3 Chint Solar (Zhejiang) Co., allegations. No other parties submitted regarding the calculation of the Ltd...... 10.64 ministerial allegations or comments on benchmark used to calculate benefits in Dongguan Sunworth Solar Canadian Solar’s allegations. the Aluminum Extrusions for Less Than Energy Co., Ltd...... 10.64 Complaints were filed with the U.S. Adequate Remuneration (LTAR) ERA Solar Co., Ltd...... 10.64 Court of International Trade (the Court, Program constitutes a ministerial error ET Solar Energy Limited ...... 10.64 or CIT) challenging the Final Results. within the meaning of 19 CFR ET Solar Industry Limited ..... 10.64 The United States sought leave from the 351.224(f).5 Hainan Yingli New Energy Resources Co., Ltd...... 10.64 Court to address these ministerial error In accordance with section 751(h) of Hangzhou Sunny Energy allegations. The Court granted the the Act and 19 CFR 351.224(e), we are Science and Technology United States’ request and allowed until amending the Final Results to correct Co., Ltd...... 10.64 November 5, 2018, to issue any the ministerial error. Specifically, we Hangzhou Zhejiang Univer- amended final results. are amending the net subsidy rates for sity Sunny Energy Science the mandatory company respondents and Technology Co., Ltd. 10.64 Scope of the Order Hengdian Group DMEGC (i.e., Canadian Solar and Changzhou The merchandise covered by this Magnetics Co., Ltd...... 10.64 Trina Solar Energy Co., Ltd.) and for the order is crystalline silicon photovoltaic Hengshui Yingli New Energy companies for which a review was Resources Co., Ltd...... 10.64 requested that were not selected as JA Solar Technology 1 See Crystalline Silicon Photovoltaic Cells, Whether or Not Assembled Into Modules, From the mandatory company respondents (i.e., Yangzhou Co., Ltd...... 10.64 People’s Republic of China: Final Results of the non-selected companies subject to Countervailing Duty Administrative Review; 2015, this review).6 The revised net subsidy 7 Cross-owned affiliates are: Canadian Solar Inc.; 83 FR 34828 (July 23, 2018) (Final Results) and rates are provided below. Canadian Solar Manufacturing (Luoyang) Inc.; accompanying Issues and Decision Memorandum Canadian Solar Manufacturing (Changshu) Inc.; CSI (Decision Memorandum). Cells Co., Ltd.; CSI Solar Power (China) Inc.; CSI 2 See Letter from Canadian Solar, ‘‘Crystalline 4 See Final Results Decision Memorandum at Solartronics (Changshu) Co., Ltd.; CSI Solar Silicon Photovoltaic Cells, Whether or Not 3–4. Technologies Inc.; CSI Solar Manufacture Inc. Assembled into Modules from the People’s 5 See Memorandum, ‘‘Administrative Review of (name was changed to CSI New Energy Holding Co., Republic of China: Ministerial Error Comments,’’ the Countervailing Duty Order on Crystalline Ltd. in July 2015); CSI–GCL Solar Manufacturing dated August 2, 2018; see also Memorandum, Silicon Photovoltaic Cells, Whether or Not (Yancheng) Co., Ltd.; Changshu Tegu New Materials ‘‘Administrative Review of the Countervailing Duty Assembled Into Modules, from the People’s Technology Co., Ltd.; Changshu Tlian Co., Ltd.; and Order on Crystalline Silicon Photovoltaic Cells, Republic of China, 2015; Response to Ministerial Suzhou Sanysolar Materials Technology Co., Ltd. Whether or Not Assembled Into Modules, from the Error Allegations in the Final Results,’’ dated See Preliminary Decision Memorandum. People’s Republic of China: Extension of Deadline concurrently with this notice (Response to 8 Cross-owned affiliates are: Changzhou Trina for Ministerial Error Comments,’’ dated July 30, Ministerial Error Allegations). Solar Energy Co., Ltd.; Trina Solar (Changzhou) 2018. 6 Consistent with the Final Results, for the non- Science and Technology Co., Ltd.; Yancheng Trina 3 See Letter from the petitioner, ‘‘Crystalline selected companies, we calculated an amended rate Solar Energy Technology Co., Ltd.; Changzhou Silicon Photovoltaic Cells, Whether or Not by weight-averaging the amended subsidy rates of Trina Solar Yabang Energy Co., Ltd.; Hubei Trina Assembled into Modules, from the People’s the two mandatory respondents using their Solar Energy Co., Ltd.; Turpan Trina Solar Energy Republic of China: Rebuttal to Canadian Solar’s publicly-ranged sales data for exports of subject Co., Ltd.; and Changzhou Trina PV Ribbon Ministerial Error Comments,’’ dated August 7, 2018. merchandise to the United States during the POR. Materials Co., Ltd.

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Subsidy rate instruct CBP to assess countervailing DEPARTMENT OF COMMERCE Producer/exporter (percent ad duties on those enjoined entries valorem) pending resolution of the associated International Trade Administration Jiangsu High Hope Int’l litigation. [A–570–082] Group ...... 10.64 Commerce intends to instruct CBP to Jiawei Solarchina Co., Ltd. ... 10.64 collect cash deposits of estimated Certain Steel Wheels From the People’s Republic of China: Jiawei Solarchina countervailing duties, in the amounts (Shenzhen) Co., Ltd...... 10.64 Preliminary Determination of Sales at shown above for the companies listed JingAo Solar Co., Ltd...... 10.64 Less-Than-Fair-Value Jinko Solar Co., Ltd...... 10.64 above, on shipments of subject Jinko Solar Import and Ex- merchandise entered, or withdrawn AGENCY: Enforcement and Compliance, port Co., Ltd...... 10.64 from warehouse, for consumption on or International Trade Administration, Jinko Solar International Lim- after July 23, 2018, which is the date of Department of Commerce. ited ...... 10.64 publication of the Final Results. For all SUMMARY: The Department of Commerce Jinko Solar (U.S.) Inc...... 10.64 (Commerce) preliminarily determines Lightway Green New Energy non-reviewed firms, we will instruct CBP to collect cash deposits at the most that steel wheels from the People’s Co., Ltd...... 10.64 Republic of China (China) are being, or Lixian Yingli New Energy Re- recent company-specific or all-others are likely to be, sold in the United States sources Co., Ltd...... 10.64 rate applicable to the company, as at less-than-fair-value (LTFV) for the Luoyang Suntech Power Co., appropriate. These cash deposit period of investigation (POI) July 1, Ltd...... 10.64 requirements, when imposed, shall Ningbo Qixin Solar Electrical 2017, through December 31, 2017. Appliance Co., Ltd...... 10.64 remain in effect until further notice. Interested parties are invited to Risen Energy Co., Ltd...... 10.64 Administrative Protective Order comment on this preliminary Shanghai JA Solar Tech- determination. nology Co., Ltd...... 10.64 This notice also serves as a reminder Shenzhen Glory Industries DATES: Applicable October 30, 2018. to parties that are subject to Co., Ltd...... 10.64 FOR FURTHER INFORMATION CONTACT: Shenzhen Topray Solar Co., administrative protective order (APO) of Lingjun Wang, AD/CVD Operations, Ltd...... 10.64 their responsibility concerning the Office VII, Enforcement and Sumec Hardware & Tools return or destruction of proprietary Compliance, International Trade Co. Ltd...... 10.64 information disclosed under APO in Administration, U.S. Department of Systemes Versilis, Inc...... 10.64 accordance with 19 CFR 351.305(a)(3), Taizhou BD Trade Co., Ltd. 10.64 Commerce, 1401 Constitution Avenue tenKsolar (Shanghai) Co., which continues to govern business NW, Washington, DC 20230; telephone: Ltd...... 10.64 proprietary information in this segment (202) 482–2316. Tianjin Yingli New Energy of the proceeding. Timely written SUPPLEMENTARY INFORMATION: Resources Co., Ltd...... 10.64 notification of the return/destruction of Toenergy Technology APO materials, or conversion to judicial Background Hangzhou Co., Ltd...... 10.64 protective order, is hereby requested. This preliminary determination is Wuxi Suntech Power Co., Failure to comply with the regulations made in accordance with section 733(b) Ltd...... 10.64 of the Tariff Act of 1930, as amended Yingli Energy (China) Co., and the terms of an APO is a Ltd...... 10.64 sanctionable violation. (the Act). Commerce published the Zhejiang Era Solar Tech- notice of initiation of this investigation nology Co., Ltd...... 10.64 Disclosure on April 24, 2018.1 On August 20, 2018, Zhejiang Jinko Solar Co., Commerce postponed the preliminary Ltd...... 10.64 We intend to disclose the calculations determination of this investigation and Zhejiang Sunflower Light En- performed for these amended final the revised deadline is now October 23, ergy Science & Tech- results to interested parties within five 2018.2 For a complete description of the nology Limited Liability business days of the date of publication events that followed the initiation of Company ...... 10.64 of this notice in accordance with 19 CFR this investigation, see the Preliminary 351.224(b). Decision Memorandum.3 A list of topics Assessment Rates/Cash Deposits We are issuing and publishing these included in the Preliminary Decision Normally, Commerce would issue results in accordance with section Memorandum is included as Appendix appropriate assessment instructions to 751(h) and 777(i)(1) of the Act, and 19 II to this notice. The Preliminary U.S. Customs and Border Protection CFR 351.224(e). Decision Memorandum is a public (CBP) 15 days after the date of document and is on file electronically publication of these amended final Dated: October 25, 2018. via Enforcement and Compliance’s results of review, to liquidate shipments Gary Taverman, Antidumping and Countervailing Duty of subject merchandise produced and/or Deputy Assistant Secretary for Antidumping exported by the companies listed above and Countervailing Duty Operations 1 See Certain Steel Wheels from the People’s entered, or withdrawn from warehouse, performing the non-exclusive functions and Republic of China: Initiation of Less-Than-Fair- for consumption on or after January 1, duties of the Assistant Secretary for Value Investigation, 83 FR 17798 (April 24, 2018) 2015, through December 31, 2015. Enforcement and Compliance. (Initiation Notice). 2 See Steel Wheels from the People’s Republic of However, on August 31, 2018, and on [FR Doc. 2018–23667 Filed 10–29–18; 8:45 am] China: Postponement of Preliminary Determination September 20 and 24, 2018, the CIT BILLING CODE 3510–DS–P in the Less-Than-Fair-Value Investigation, 83 FR enjoined liquidation of certain entries 42110 (August 20, 2018). that are subject to the Final Results.9 3 See Memorandum re: Decision Memorandum for the Preliminary Determination in the Less-Than- Accordingly, Commerce will not Fair-Value Investigation of Certain Steel Wheels from the People’s Republic of China, dated 9 The CIT issued the statutory injunctions in case concurrently with, and hereby adopted by, this numbers 18–00184, 18–00185, and 18–00186. notice (Preliminary Decision Memorandum).

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Centralized Electronic Service System Notice set aside a period of time for eligibility for a separate rate; thus, all (ACCESS). ACCESS is available to parties to raise issues regarding product companies are preliminarily found to be registered users at https:// coverage (i.e., scope).5 No interested part of the China-wide entity. access.trade.gov, and it is available to party commented on the scope of the Furthermore, we find that the China- all parties in the Central Records Unit, investigation as it appeared in the wide entity’s lack of participation, room B8024 of the main building of Initiation Notice. Commerce is not including the failure of certain parts of Commerce. In addition, a complete modifying the scope language as it the China-wide entity to respond to version of the Preliminary Decision appeared in the Initiation Notice. See Commerce’s questionnaires, constitute Memorandum can be accessed directly the scope in Appendix I. circumstances under which it is at http://enforcement.trade.gov/frn/. reasonable to conclude that the China- The signed and the electronic versions Methodology wide entity as a whole failed to of the Preliminary Decision Commerce is conducting this Memorandum are identical in content. cooperate to the best of its ability to investigation in accordance with section comply with Commerce’s requests for Scope of the Investigation 731 of the Act. Pursuant to section information. For a full description of the The products covered by this 776(a) and (b) of the Act, we have methodology underlying Commerce’s investigation are steel wheels from preliminarily relied upon facts preliminary determination, see the China. For a complete description of the otherwise available, with adverse Preliminary Decision Memorandum. scope of this investigation, see inferences, for the China-wide entity Appendix I. because it did not respond to our Preliminary Determination requests for information. Specifically, Commerce preliminarily determines Scope Comments two mandatory respondents withdrew that the following estimated weighted- In accordance with the preamble to their participation, and no other Commerce’s regulations,4 the Initiation companies have demonstrated their average dumping margins exist:

Estimated weighted- average Producer Exporter dumping margin (percent)

China-Wide Entity ...... China-Wide Entity ...... 231.70

Suspension of Liquidation average dumping margin by the is based solely on the petition, there are In accordance with section 733(d)(2) appropriate rate(s). As discussed in the no calculations to disclose. Preliminary Decision Memorandum, we of the Act, Commerce will direct U.S. Verification Customs and Border Protection (CBP) to have made no adjustment for domestic suspend liquidation of subject subsidy pass-through. As further Because the mandatory respondents merchandise as described in the scope explained in the Preliminary Decision withdrew their participation, Commerce of the investigation section entered, or Memorandum, as an extension of our preliminarily determines each of the withdrawn from warehouse, for AFA finding for the China-wide entity, mandatory respondents to have been consumption on or after the date of the appropriate export subsidy uncooperative, and verification of publication of this notice in the Federal adjustment is the lowest amount of Sunrise and Jingu will not be Register, as discussed below. Further, export subsidies found for any conducted. pursuant to section 733(d)(1)(B) of the respondent in the companion CVD Act and 19 CFR 351.205(d), Commerce investigation, which is zero. Public Comment will instruct CBP to require a cash These suspension of liquidation deposit equal to the amount by which Case briefs or other written comments instructions will remain in effect until may be submitted to the Assistant normal value exceeds U.S. price, further notice. adjusted, as appropriate, for export Secretary for Enforcement and subsidies, as indicated in the chart Disclosure Compliance no later than 45 days after above. the date of publication of the To determine the cash deposit rate, Normally, Commerce discloses to preliminary determination, unless the Commerce normally adjusts the interested parties the calculations Secretary alters the time limit. Rebuttal estimated weighted-average dumping performed in connection with a briefs, limited to issues raised in case margin by the amount of domestic preliminary determination within five briefs, may be submitted no later than subsidy pass-through and export days of its public announcement or, if five days after the deadline date for case subsidies determined in a companion there is no public announcement, briefs.6 Pursuant to 19 CFR CVD proceeding when CVD provisional within five days of the date of 351.309(c)(2) and (d)(2), parties who measures are in effect. Accordingly, publication of this notice in accordance submit case briefs or rebuttal briefs in where Commerce has made a with 19 CFR 351.224(b). However, this investigation are encouraged to preliminary affirmative determination because Commerce preliminarily submit with each argument: (1) A for domestic subsidy pass-through or applied total AFA to companies in this statement of the issue; (2) a brief export subsidies, Commerce has offset investigation in accordance with section summary of the argument; and (3) a the calculated estimated weighted- 776 of the Act, and the applied AFA rate table of authorities.

4 See Antidumping Duties; Countervailing Duties, 5 See Initiation Notice. 6 See 19 CFR 351.309; see also 19 CFR 351.303 Final Rule, 62 FR 27296, 27323 (May 19, 1997). (for general filing requirements).

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Pursuant to 19 CFR 351.310(c), Dated: October 23, 2018. Harmonized Tariff Schedule of the United interested parties who wish to request a Gary Taverman, States (HTSUS) subheadings: 8708.70.4530, hearing, limited to issues raised in the Deputy Assistant Secretary for Antidumping 8708.70.4560, 8708.70.6030, 8708.70.6060, case and rebuttal briefs, must submit a and Countervailing Duty Operations, 8716.90.5045, and 8716.90.5059. performing the non-exclusive functions and Merchandise meeting the scope description written request to the Assistant may also enter under the following HTSUS Secretary for Enforcement and duties of the Assistant Secretary for Enforcement and Compliance. subheadings: 4011.20.1015, 4011.20.5020, Compliance, U.S. Department of and 8708.99.4850. While HTSUS Commerce, within 30 days after the date Appendix I subheadings are provided for convenience of publication of this notice. Requests and customs purposes, the written Scope of the Investigation should contain the party’s name, description of the subject merchandise is address, and telephone number, the The merchandise subject to the dispositive. investigation is certain on-the-road steel number of participants, whether any wheels, discs, and rims for tubeless tires, Appendix II participant is a foreign national, and a with a nominal rim diameter of 22.5 inches list of the issues to be discussed. If a List of Topics Discussed in the Preliminary and 24.5 inches, regardless of width. Certain Decision Memorandum request for a hearing is made, Commerce on-the-road steel wheels with a nominal intends to hold the hearing at the U.S. wheel diameter of 22.5 inches and 24.5 I. Summary Department of Commerce, 1401 inches are generally for Class 6, 7, and 8 II. Background commercial vehicles (as classified by the III. Period of Investigation Constitution Avenue NW, Washington, IV. Scope Of the Investigation DC 20230, at a time and date to be Federal Highway Administration Gross Vehicle Weight Rating system), including V. Discussion of the Methodology determined. Parties should confirm the tractors, semi-trailers, dump trucks, garbage A. Non-Market Economy Country date, time, and location of the hearing trucks, concrete mixers, and buses, and are B. Separate Rate Status two days before the scheduled date. the current standard wheel diameters for C. The China-wide Entity such applications. The standard widths of D. Application of Facts Available and Final Determination certain on-the-road steel wheels are 7.5 Adverse Inferences inches, 8.25 inches, and 9.0 inches, but all VI. Adjustments Under Section 777(A)(F) of Section 735(a)(1) of the Act and 19 certain on-the-road steel wheels, regardless of the Act CFR 351.210(b)(1) provide that width, are covered by the scope. While 22.5 VII. Adjustments Under Section 772(C) of the Commerce will issue the final inches and 24.5 inches are standard wheel Act determination within 75 days after the sizes used by Class 6, 7, and 8 commercial VIII. Conclusion date of its preliminary determination. vehicles, the scope covers sizes that may be [FR Doc. 2018–23661 Filed 10–29–18; 8:45 am] However, on August 15, 2018, pursuant adopted in the future for Class 6, 7, and 8 BILLING CODE 3510–DS–P to section 735(a)(2) of the Act, Sunrise commercial vehicles. requested that Commerce postpone the The scope includes certain on-the-road steel wheels with either a ‘‘hub-piloted’’ or DEPARTMENT OF COMMERCE final determination and extend ‘‘stud-piloted’’ mounting configuration, and provisional measures from four months includes rims and discs for such wheels, National Oceanic and Atmospheric to six months.7 In accordance with 19 whether imported as an assembly or CFR 351.210(e)(2), we are still separately. The scope includes certain on- Administration considering this request. Should we the-road steel wheels, discs, and rims, of RIN 0648–XG371 determine to postpone the final carbon and/or alloy steel composition, determination and extend provisional whether cladded or not cladded, whether Marine Mammals; File No. 22095 measures, we will publish a notification finished or not finished, and whether coated or uncoated. All on-the-road wheels sold in AGENCY: National Marine Fisheries in the Federal Register.8 the United States are subject to the Service (NMFS), National Oceanic and International Trade Commission requirements of the National Highway Traffic Atmospheric Administration (NOAA), Notification Safety Administration and bear markings, Commerce. such as the ‘‘DOT’’ symbol, indicating ACTION: Notice; receipt of application. In accordance with section 733(f) of compliance with applicable motor vehicle the Act, Commerce will notify the standards. See 49 CFR 571.120. The scope SUMMARY: Notice is hereby given that includes certain on-the-road steel wheels SeaWorld, LLC., 9205 Southpark Center International Trade Commission (ITC) of imported with or without the required its preliminary determination of sales at markings. Certain on-the-road steel wheels Loop, Suite 400, Orlando, FL 32819 LTFV. If the final determination is imported as an assembly with a tire mounted (Responsible Party: Christopher Dold, affirmative, the ITC will determine on the wheel and/or with a valve stem DVM), has applied in due form for a before the later of 120 days after the date attached are included. However, if the certain scientific research and enhancement of this preliminary determination or 45 on-the-road steel wheel is imported as an permit for one non-releasable beluga days after the final determination assembly with a tire mounted on the wheel whale (Delphinapterus leucas) from the whether imports of the subject and/or with a valve stem attached, the certain Cook Inlet distinct population segment on-the-road steel wheel is covered by the (DPS). merchandise are materially injuring, or scope, but the tire and/or valve stem is not threaten material injury to, the U.S. covered by the scope. DATES: Written, telefaxed, or email industry. Excluded from the scope are: comments must be received on or before (1) Steel wheels for tube-type tires that November 29, 2018. Notification to Interested Parties require a removable side ring; ADDRESSES: The application and related This determination is issued and (2) aluminum wheels; documents are available for review by (3) wheels where steel represents less than published in accordance with sections selecting ‘‘Records Open for Public fifty percent of the product by weight; and Comment’’ from the ‘‘Features’’ box on 733(f) and 777(i)(1) of the Act and 19 (4) steel wheels that do not meet National CFR 351.205(c). Highway Traffic Safety Administration the Applications and Permits for requirements, other than the rim marking Protected Species (APPS) home page, 7 See Sunrise’s August 15, 2018 Request to requirements found in 49 CFR 571.120S5.2. https://apps.nmfs.noaa.gov, and then Postpone Final Determination. Imports of the subject merchandise are selecting File No. 22095 from the list of 8 See 19 CFR 351.210(g). currently classified under the following available applications.

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These documents are also available MMHSRP permit (No. 18786–03). ACTION: Notice; issuance of permits. upon written request or by appointment SeaWorld is now applying for their own in the Permits and Conservation scientific research and enhancement SUMMARY: Notice is hereby given that Division, Office of Protected Resources, permit for the long-term care of this individuals and institutions have been NMFS, 1315 East-West Highway, Room non-releasable animal and to conduct issued Letters of Confirmation for 13705, Silver Spring, MD 20910; phone research to benefit the endangered wild activities conducted under the General (301) 427–8401; fax (301) 713–0376. population of Cook Inlet beluga whales. Authorization for Scientific Research on Written comments on this application SeaWorld’s proposed research marine mammals. See SUPPLEMENTARY should be submitted to the Chief, activities for this beluga whale include INFORMATION for a list of names and Permits and Conservation Division, at investigations of vocalizations (passive address of recipients. the address listed above. Comments may recordings) and hearing development ADDRESSES: The Letters of Confirmation also be submitted by facsimile to (301) (auditory evoked potential and related documents are available for 713–0376, or by email to measurements). The proposed review upon written request or by [email protected]. Please enhancement would include appointment in the following office: include File No. 22095 in the subject educational presentations on topics Permits and Conservation Division, line of the email comment. including the endangered status and Office of Protected Resources, NMFS, Those individuals requesting a public current threats to the Cook Inlet DPS; 1315 East-West Highway, Room 13705, hearing should submit a written request continued daily husbandry care Silver Spring, MD 20910; phone (301) to the Chief, Permits and Conservation (feeding, training, and monitoring 427–8401; fax (301) 713–0376. Division at the address listed above. The growth (measurements, weight, FOR FURTHER INFORMATION CONTACT: request should set forth the specific ultrasound)); veterinary care (exams and Office of Protected Resources, Permits reasons why a hearing on this biological sampling including but not and Conservation Division, (301) 427– application would be appropriate. limited to blood, exhalate, swabs, urine, 8401. FOR FURTHER INFORMATION CONTACT: feces; and treatments as warranted); and SUPPLEMENTARY INFORMATION: The Amy Sloan, Jennifer Skidmore, or behavioral observations and requested Letters of Confirmation have Courtney Smith, (301) 427–8401. enrichment. This animal would be been issued under the authority of the SUPPLEMENTARY INFORMATION: The placed on public display incidental to Marine Mammal Protection Act of 1972, subject permit is requested under the the proposed activities but would not be as amended (16 U.S.C. 1361 et seq.), and authority of the Marine Mammal used in interactive programs with the the regulations governing the taking and Protection Act of 1972, as amended public or trained for performance. importing of marine mammals (50 CFR (MMPA; 16 U.S.C. 1361 et seq.), the Presentations to educate the public may part 216). The General Authorization regulations governing the taking and include demonstrations of trained allows for bona fide scientific research importing of marine mammals (50 CFR husbandry and enrichment behaviors as that may result only in taking by Level part 216), the Endangered Species Act of well as natural behaviors. The permit is B harassment of marine mammals. The 1973, as amended (ESA; 16 U.S.C. 1531 requested for a 5-year period, the following Letters of Confirmation (LOC) et seq.), and the regulations governing maximum duration of a permit. were issued in Fiscal Year 2018 the taking, importing, and exporting of In compliance with the National (October 1, 2017—September 30, 2018). endangered and threatened species (50 Environmental Policy Act of 1969 (42 File No. 19826–01: Issued to Tara CFR parts 222–226). U.S.C. 4321 et seq.), an initial Moll, Naval Undersea Warfare Center, The applicant proposes to conduct determination has been made that the Division Newport, 1176 Howell Street, research on and provide long-term care activity proposed is categorically Newport, RI, 02841 on November 6, for one male beluga whale calf from the excluded from the requirement to 2017, to conduct ground and vessel Cook Inlet DPS. The calf stranded alone prepare an environmental assessment or surveys, photo-identification, and as a neonate when he was less than a environmental impact statement. behavioral observations of gray month old, and was rescued and NMFS has forwarded the application (Halichoerus grypus), harbor (Phoca rehabilitated by the Alaska marine to the Marine Mammal Commission and vitulina), and harp (Pagophilus mammal stranding network under the its Committee of Scientific Advisors. groenlandicus) seals in lower authority of the NMFS Marine Mammal Dated: October 24, 2018. Chesapeake Bay, VA and Narragansett Health and Stranding Response Julia M. Harrison, Bay, RI. The amended LOC expands the Program’s (MMHSRP) scientific research Chief, Permits and Conservation Division, location of research activities in Virginia and enhancement permit. Based on his Office of Protected Resources, National to include the eastern Atlantic shore of young age, health conditions, and need Marine Fisheries Service. Virginia, rather than just coastlines for socialization with other beluga [FR Doc. 2018–23652 Filed 10–29–18; 8:45 am] within the Chesapeake Bay. The LOC whales, NMFS determined him to be BILLING CODE 3510–22–P expires on January 31, 2021. non-releasable and unable to survive in File No. 21363: Issued to David the wild, and chose SeaWorld of Texas Johnston, Ph.D., Assistant Professor of to accept Tyonek into their beluga DEPARTMENT OF COMMERCE the Practice, Duke University, Marine population, which was best suited for Science and Conservation, 135 Duke his needs. NMFS followed the standard National Oceanic and Atmospheric Marine Lab Rd., Beaufort, NC, 28516 on placement process for non-releasable Administration November 9, 2017, to use unmanned marine mammals as outlined in the aircraft systems to count and NMFS Placement Process for Non- RIN 0648–XG558 photograph 11 pinniped species. Images releasable Marine Mammals, No. 02– Marine Mammals; Issuance of Permits will be used for photogrammetry, health 308–02, which is available at: http:// assessments and habitat descriptions. www.nmfs.noaa.gov/op/pds/ AGENCY: National Marine Fisheries Research may occur in three different documents/02/308/02-308-02.pdf. The Service (NMFS), National Oceanic and areas: (1) Along the U.S. east coast from calf is currently held at SeaWorld of Atmospheric Administration (NOAA), Maine to South Carolina; (2) along the Texas under the authority of the Commerce. U.S. West Coast from Alaska to

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California; and (3) along the Western Atmospheric Sciences, Stony Brook from the requirement to prepare an Antarctic Peninsula. The objectives are University, Stony Brook, NY, 11794 on environmental assessment or to determine the density and April 23, 2018, to conduct vessel and environmental impact statement. distribution of non-listed pinnipeds unmanned aircraft system (UAS) Dated: October 24, 2018. using risk adverse and low impact surveys of 18 cetacean species. Animals Julia Harrison, technology. The LOC expires on may be approached for photo- November 15, 2022. identification, photogrammetry, Chief, Permits and Conservation Division, File No. 19826–02: Issued to Deanna Office of Protected Resources, National behavioral observations, and abundance Marine Fisheries Service. Rees, Naval Undersea Warfare Center, estimates. Research may occur in the [FR Doc. 2018–23653 Filed 10–29–18; 8:45 am] Division Newport, 1176 Howell Street, New York Bight up to 120 nm offshore. Newport, RI 02841 on November 28, The objective of the research is to BILLING CODE 3510–22–P 2017, to conduct ground and vessel provide detailed species-level surveys, photo-identification, and information on the abundance, DEPARTMENT OF COMMERCE behavioral observations of gray, harbor, distribution, movements and body and harp seals in Virginia and condition of cetaceans within the study National Oceanic and Atmospheric Narragansett Bay, RI. The amended LOC area to the New York State Department Administration changes the Principal Investigator. The of Environmental Conservation as part objectives do not change from those of an offshore monitoring program. The Public Meeting for Recommending a authorized under LOC No. 19826–01. LOC expires on July 30, 2023. National Estuarine Research Reserve The LOC expires on January 31, 2021. File No. 21556: Issued to Stephen Site in Connecticut’s Lower File No. 19613: Issued to Eric Zolman, McCulloch, Dolphins Plus, 31 Corrine Connecticut River and Eastern Long NOAA National Ocean Service, Hollings Place, Key Largo, FL 33037 on May 14, Island Sound Marine Laboratory, 331 Ft. Johnson, 2018 to conduct vessel surveys targeting Charleston, SC, 29412–9110 on bottlenose dolphins to include close AGENCY: Office for Coastal Management, December 21, 2017, to conduct research approach for counts, photo- National Ocean Service, National on bottlenose dolphins (Tursiops identification, video recording, and Oceanic and Atmospheric truncatus) within coastal waters of the behavioral observations in the Upper Administration, U.S. Department of southeastern United States (including Florida Keys, between North Key Largo Commerce. the western North Atlantic and northern to Islamorada, FL. The objectives of the ACTION: Public meeting notice. Gulf of Mexico). Dolphins may be research are to provide a contemporary closely approached during vessel account of common bottlenose dolphins SUMMARY: Notice is hereby given that a surveys for the purposes of photo- utilizing the Upper Florida Keys. The public meeting will be held for the identification and behavioral LOC expires on May 15, 2023. purpose of providing information and observations to address the following File No. 22198: Issued to Samuel receiving comments on the preliminary objectives: (1) To estimate abundance of Wasser, Ph.D., Center for Conservation recommendation by the State of specific inshore bottlenose dolphin Biology, University of Washington, Connecticut that portions of the Lower stocks; (2) to better define stock Seattle, WA 98195 on May 22, 2018, to Connecticut River and Eastern Long boundaries in targeted regions; and (3) conduct boat-based vessel surveys Island Sound be proposed to NOAA for to assess the status and health of targeting killer whales (Orcinus orca, designation as a National Estuarine targeted dolphin populations. The LOC West Coast Transient stock) within the Research Reserve. expires on January 1, 2023. inland waters of Washington State. The public meeting will be held at 6 File No. 18101–03: Issued to Jens Whales may be approached during focal p.m. on November 13, 2018 in the Currie, Pacific Whale Foundation, 300 follows for photo-identification, Academic Building Auditorium at the Ma’alaea Rd., Suite 211, Wailuku, HI behavioral observations, and fecal University of Connecticut’s Avery Point 96793 on March 23, 2018. The amended sample collection. The objective of the campus, located at 1084 Shennecossett Letter of Confirmation changes the research is to, through analysis of feces, Rd, Groton, CT 06340. Principal Investigator and applicant, address the physiologic measures of and extends the LOC by one year for nutritional stress with variation in prey The state agencies holding the vessel-based research activities on abundance, toxicant levels and boat meeting: The Connecticut Department of cetaceans within the Maui-4 islands traffic to endpoint measures such as Energy and Environmental Protection’s area. The objectives do not change from successful birth outcomes and annual Coastal Management Program; the those authorized under LOC No. 18101– mortality. The LOC expires on July 15, University of Connecticut; and 02. The LOC expires on June 21, 2019. 2019. Connecticut Sea Grant. NOAA’s Office File No. 21932: Issued to Jessica File No. 20519–01: Issued to Peggy for Coastal Management will assist with Taylor, Outer Banks Center for Dolphin Stap, Marine Life Studies, P.O. Box 884, the meeting. Research, 310 West Eden St., Kill Devil Monterey, CA 93942–0884 on June 27, The proposed research reserve site is Hills, NC 27948 on April 4, 2018, to 2018. The amended LOC allows for the comprised of the following state-owned conduct vessel surveys of bottlenose use of small UAS to determine the properties: Lord Cove Wildlife dolphins in the waters of northern number of marine mammals in a group Management Area; Great Island Wildlife North Carolina. Animals may be and for photogrammetry of Transient Management Area; Bluff Point State approached for photo-identification, and Offshore killer whales. The Park and Coastal Reserve and Natural behavioral observations, and focal objectives do not change from those Area Preserve; Haley Farm State Park; follows. The objective of the research is authorized under LOC 20519. The LOC and the public trust portions of to continue to monitor the presence, expires on December 31, 2021. waterbodies defined by: identity, ecology, and behavior of In compliance with the National (a) Long Island Sound ranging bottlenose dolphins in the area. The Environmental Policy Act of 1969 (42 approximately west to east from the LOC expires on April 30, 2023. U.S.C. 4321 et seq.), a final mouth of the Connecticut River to File No. 21889: Issued to Lesley determination has been made that the Mason’s Island and north to south Thorne, Ph.D., School of Marine and activities are categorically excluded waterward of the mean high water

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shoreline to just shy of the Connecticut Persons with disabilities please coral reef taxa in waters of the U.S. state boundary in Long Island Sound; contact Michelle MarcAurele at the exclusive economic zone in the western (b) the area waterward of the mean University of Connecticut Avery Point Pacific region. These data are needed to high shoreline of the lower Thames campus by November 6, 2018 to make determine the condition of the stocks, River from approximately the Gold Star arrangements. Phone: 860–405–9115, whether the current management Bridge south to the area described in (a); Email: [email protected]. measures are having the intended (c) the area waterward of the mean (Federal Domestic Assistance Catalog effects, and to evaluate the benefits and high shoreline of the lower Connecticut Number 11.420 (Coastal Zone Management) costs of changes in management River from approximately Lord Cove Research Reserves) measures. The logbook information south to the area described in (a). Dated: October 22, 2018. includes interactions with protected The views of interested persons and species, including sea turtles, monk Paul M. Scholz, organizations regarding the proposed seals, and other marine mammals, site recommendation are solicited. This Associate Assistant Administrator for which are used to monitor and respond information may be expressed orally Management and CFO/CAO, Ocean Services and Coastal Zone Management. to incidental takes of endangered and and in written statements. A threatened marine species. presentation about the proposed site [FR Doc. 2018–23607 Filed 10–29–18; 8:45 am] Affected Public: Business or other for- and the National Estuarine Research BILLING CODE 3510–22–P profit organizations; individuals or Reserve System will be provided. households. Written comments may be also be sent DEPARTMENT OF COMMERCE Frequency: On occasion. to: Kevin O’Brien, Connecticut Respondent’s Obligation: Mandatory. Department of Energy and This information collection request Environmental Protection—Land & National Oceanic and Atmospheric Administration may be viewed at reginfo.gov. Follow Water Resources Division, 79 Elm the instructions to view Department of Street, Hartford, CT 06106–5127 or to: Submission for OMB Review; Commerce collections currently under [email protected]. All written Comment Request review by OMB. comments must be received no later Written comments and than seven calendar days following the The Department of Commerce will recommendations for the proposed public meeting. All comments received submit to the Office of Management and information collection should be sent will be considered by the State in Budget (OMB) for clearance the within 30 days of publication of this formally nominating a site to NOAA. following proposal for collection of _ The research reserve system is a notice to OIRA Submission@ information under the provisions of the omb.eop.gov or fax to (202) 395–5806. federal and state partnership program Paperwork Reduction Act (44 U.S.C. administered by the federal government, Chapter 35). Dated: October 25, 2018. specifically the National Oceanic and Agency: National Oceanic and Sarah Brabson, Atmospheric Administration (NOAA). Atmospheric Administration (NOAA). NOAA PRA Clearance Officer. The research reserve system currently Title: Pacific Islands Region Coral [FR Doc. 2018–23640 Filed 10–29–18; 8:45 am] has 29 sites and protects more than 1.3 Reef Ecosystems Logbook and BILLING CODE 3510–22–P million acres of estuarine and Great Reporting. Lakes habitat for long-term research, OMB Control Number: 0648–0462. monitoring, education, and stewardship. Form Number(s): None. DEPARTMENT OF COMMERCE Established by the Coastal Zone Type of Request: Regular (extension of Management Act of 1972, each reserve a currently approved information National Oceanic and Atmospheric is managed by a lead state agency or collection). Administration university, with input from local Number of Respondents: 5. RIN 0648–XG567 partners. NOAA provides partial Average Hours per Response: Pre-trip funding and national programmatic and pre-landing notifications, 3 Nominations for the 2019–2022 guidance. minutes; logbook reports, 30 minutes; General Advisory Committee and the This particular site selection effort is transshipment reports, 15 minutes. Scientific Advisory Subcommittee to a culmination of several years of local, Burden Hours: 18. the United States Delegation to the grassroots-support for a research reserve Needs and Uses: This request is for Inter-American Tropical Tuna site in Connecticut. The preliminary site extension of a current information Commission recommendation follows a collection. comprehensive evaluation process that The National Marine Fisheries Service AGENCY: National Marine Fisheries sought the views of the public, affected (NMFS) requires any U.S. citizen issued Service, National Oceanic and landowners, and other interested a Special Coral Reef Ecosystem Fishing Atmospheric Administration, parties. State and local agency Permit to complete logbooks and submit Commerce. representatives, as well as estuarine them to NMFS (50 CFR 665). The ACTION: Notice; request for nominations. experts, served as committee members Special Coral Reef Ecosystem Fishing and evaluated site proposals. The Permit is authorized under the Fishery SUMMARY: National Marine Fisheries committee is recommending the Lower Ecosystem Plans for American Samoa Service, on behalf of the Secretary of Connecticut River and Eastern Long Archipelago, Hawaiian Archipelago, Commerce, is seeking nominations for Island Sound as the preferred site for Mariana Archipelago, and Pacific the General Advisory Committee to the the state to nominate to NOAA. Remote Island Areas. The information U.S. delegation to the Inter-American FOR FURTHER INFORMATION CONTACT: Ms. in the logbooks is used to obtain fish Tropical Tuna Commission, as well as Erica Seiden, Office for Coastal catch/fishing effort data on coral reef to a Scientific Advisory Subcommittee Management, National Ocean Service, fishes and invertebrates harvested in of the General Advisory Committee. The NOAA, 1305 East West Highway, N/ designated low-use marine protected purpose of the General Advisory OCM, Silver Spring, MD 20910 or areas and on those listed in the Committee and its Scientific Advisory Email: [email protected]. regulations as potentially-harvested Subcommittee is to provide public input

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and advice to the U.S. delegation in the members of the U.S. delegation to the recommendations to the U.S. formulation of policy and positions at Commission and its working groups to Government regarding research needs meetings of the Inter-American Tropical the extent that the Commission rules related to the eastern Pacific Ocean tuna Tuna Commission and its subsidiary and space for delegations allow. purse seine fishery; (4) promoting the bodies. The Scientific Advisory Meetings of the GAC, except when in regular and timely full exchange of data Subcommittee shall also function as the executive session, shall be open to the among the AIDCP Parties on a variety of National Scientific Advisory Committee public, and prior notice of meetings matters related to the implementation of provided for in the Agreement on the shall be made public in timely fashion. the AIDCP; and (5) consulting with International Dolphin Conservation In accordance with Public Law 114–81, other experts, as necessary, in order to Program. the GAC shall not be subject to the achieve the objectives of the AIDCP. Federal Advisory Committee Act (5 DATES: Nominations must be received Members of the SAS/National U.S.C. App.). no later than November 29, 2018. Scientific Advisory Committee shall Individuals appointed to serve as a receive no compensation for their ADDRESSES: Nominations should be member of the GAC shall serve without service. directed to Barry Thom, Regional pay. While away from their homes or Administrator, NMFS West Coast regular places of business to attend General Provisions Region, and may be submitted by any of meetings of the GAC, they shall be Each member of the GAC shall be the following means: • allowed travel expenses, including per appointed for a term of 3 years and may Email: RegionalAdministrator. diem in lieu of subsistence, in the same be reappointed. The Secretary of [email protected] with the subject manner as persons employed Commerce and the Secretary of State line: ‘‘General Advisory Committee and intermittently by the Federal shall provide the GAC with relevant Scientific Advisory Subcommittee Government are allowed expenses information concerning fisheries and nominations’’ under 5 U.S.C. 5703. In addition, international fishery agreements. The • Mail: Taylor Debevec, NMFS West individuals appointed to serve as a Secretary of Commerce shall provide to Coast Region Long Beach Office, 501 W. member of the GAC shall not be the GAC such administrative and Ocean Blvd., Suite 4200, Long Beach, considered Federal employees except technical support services that are CA 90802. for the purposes of injury compensation necessary for its effective functioning in FOR FURTHER INFORMATION CONTACT: or tort. a timely manner. Taylor Debevec, NMFS West Coast Region; email: [email protected]; Scientific Advisory Subcommittee Procedures for Submitting Applications telephone: 562–980–4066. The TCA also provides that the Applications for the GAC and the SUPPLEMENTARY INFORMATION: Secretary of Commerce, in consultation SAS/National Scientific Advisory with the Secretary of State, shall General Advisory Committee Committee should be submitted to appoint persons to serve on the NMFS West Coast Region (see The Tuna Conventions Act (16 U.S.C. subcommittee of the GAC, referred to ADDRESSES). This request for 951 et seq.) (TCA) provides that the here as the ‘‘Scientific Advisory applications is for first time nominees, Secretary of Commerce, in consultation Subcommittee’’ (SAS). The SAS shall be current members whose appointments with the Secretary of State, shall composed of no fewer than 5 and no will end in April 2019, and previous appoint a ‘‘General Advisory more than 15 qualified scientists with members. Self-nomination applications Committee’’ (GAC) to advise the U.S. balanced representation from the public are acceptable. Applications should delegation to the Inter-American and private sectors, including non- include all of the following information: Tropical Tuna Commission (IATTC or governmental conservation (1) Full name, address (home and Commission). The GAC shall be organizations. In determining whether a business, if different), telephone, and composed of no more than 25 person is a qualified scientist the email address of nominee; individuals who shall be representative Secretary may consider, among other (2) Specification about whether the of the various groups concerned with things, advanced degrees and/or application is for the GAC or the SAS/ the fisheries covered by the IATTC, publications in fields such as fisheries National Scientific Advisory Committee including non-governmental or marine science. or both; conservation organizations, providing (3) Nominee’s organization(s) or National Scientific Advisory Committee an equitable balance among such groups professional affiliation(s) serving as the to the maximum extent practicable. The SAS shall also function as the basis for the nomination; Members of the GAC shall be invited to National Scientific Advisory Committee (4) Background statement describing attend all non-executive meetings of the which is required to be established the nominee’s qualifications and U.S. delegation to the IATTC and at pursuant to Article XI of the Agreement experience, especially as related to such meetings shall be given the on the International Dolphin fisheries for tuna and tuna-like species opportunity to examine and be heard on Conservation Program (AIDCP). In this in the eastern Pacific Ocean or other all proposed programs of investigation, regard, the SAS shall perform the factors relevant to the implementation reports, recommendations, and functions of the National Scientific of the Convention Establishing the regulations of the Commission. Advisory Committee as specified in IATTC or the AIDCP. Applications to The Chair of the Pacific Fishery Annex VI of the AIDCP. These functions the SAS should highlight advanced Management Council’s (Pacific Council) include, but are not limited to: (1) degrees and academic publications; and Advisory Subpanel for Highly Migratory Receiving and reviewing relevant data, (5) A written statement from the Fisheries and the Chair of the Western including data provided to NMFS by nominee of intent to participate actively Pacific Fishery Management Council’s IATTC staff; (2) advising and and in good faith in the meetings and (Western Pacific Council’s) Advisory recommending measures and actions to activities of either the GAC or the SAS/ Committee shall be ex-officio members the U.S. Government that should be National Scientific Advisory Committee, of the GAC by virtue of their positions undertaken to conserve and manage or both. advising those Councils. GAC members stocks of living marine resources in the Applicants who submitted material in will be eligible to participate as eastern Pacific Ocean; (3) making response to the Federal Register Notice

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published by NMFS on January 20, 2016 for comments and other submissions Mail Screener (81 FR 3118), or prior, should resubmit from members of the public is to make Affected Public: Individuals or their applications pursuant to this these submissions available for public households. notice. viewing on the internet at http:// Annual Burden Hours: 1,150. Authority: 16 U.S.C. 951 et seq. www.regulations.gov as they are Number of Respondents: 11,500. received without change, including any Responses per Respondent: 1. Dated: October 24, 2018. personal identifiers or contact Karen H. Abrams, Annual Responses: 11,500. information. Average Burden per Response: 6 Acting Director, Office of Sustainable Any associated form(s) for this Fisheries, National Marine Fisheries Service. minutes. collection may be located within this Frequency: One-time. [FR Doc. 2018–23634 Filed 10–29–18; 8:45 am] same electronic docket and downloaded BILLING CODE 3510–22–P for review/testing. Follow the Follow-up Telephone Survey instructions at http:// Affected Public: Individuals or www.regulations.gov for submitting households. DEPARTMENT OF DEFENSE comments. Please submit comments on Annual Burden Hours: 414. any given form identified by docket Number of Respondents: 1,242. Office of the Secretary number, form number, and title. Responses per Respondent: 1. Annual Responses: 1,242. Department of the Army FOR FURTHER INFORMATION CONTACT: To Average Burden per Response: 20 request more information on this [Docket ID: USA–2018–HQ–0024] minutes. proposed information collection or to Frequency: One-time. Proposed Collection; Comment obtain a copy of the proposal and Request associated collection instruments, Average Totals please write to the U.S. Army Corps of Annual Burden Hours: 1,564. AGENCY: U.S. Army Corps of Engineers, Engineers Omaha District, ATTN: Kelly Number of Respondents: 11,500. DoD. Baxter, 1616 Capitol Ave., Ste. 9000, Responses per Respondent: 1. ACTION: Information collection notice. Omaha, NE 68102; call at 402–995– Annual Responses: 11,500. 2447; or email at Kelly.D.Baxter@ Average Burden per Response: 8.16 SUMMARY: In compliance with the usace.army.mil. minutes. Paperwork Reduction Act of 1995, the Frequency: One-time. U.S. Army Corps of Engineers SUPPLEMENTARY INFORMATION: For a We anticipate that approximately announces a proposed public secondary source to request more 11,500 households will complete the information collection and seeks public information on this proposed mail screener. Based on the results of a comment on the provisions thereof. information collection, please write to small pretest, we expect that it will take Comments are invited on: Whether the the U.S. Army Corps of Engineers Walla approximately 1 minute to read the proposed collection of information is Walla District, ATTN: Karen Zelch, 201 screener letter and approximately 5 necessary for the proper performance of N 3rd Ave, Walla Walla, WA 99362; call minutes to complete the screener the functions of the agency, including at 509–527–7251; or email at questionnaire (total of 6 minutes per whether the information shall have [email protected]. respondent). Approximately 1,242 practical utility; the accuracy of the OMB Number: Pacific Northwest eligible adults within those households agency’s estimate of the burden of the Households Recreation Use Surveys, will complete the follow-up telephone proposed information collection; ways OMB Control Number 0710–XXXX. survey. Also based on the results of a to enhance the quality, utility, and Needs and Uses: The U.S. Army small pretest, we expect that it will take clarity of the information to be Corps of Engineers, Bonneville Power approximately 20 minutes to complete collected; and ways to minimize the Administration (BPA), and Bureau of the follow-up telephone survey. Based burden of the information collection on Reclamation (BOR), are jointly on that data, the burden for 10,258 respondents, including through the use developing an environmental impact households will be 6 minutes. The of automated collection techniques or statement (EIS), referred to as the burden for 1,242 eligible adults will be other forms of information technology. Columbia River System Operations a total of 26 minutes. This yields a total DATES: Consideration will be given to all (CRSO) EIS. As part of the EIS, the respondent burden estimate of 1,564 comments received by December 31, Corps is tasked with evaluating changes hours. 2018. in the economic value provided by Dated: October 25, 2018. water-based recreation. ADDRESSES: You may submit comments, Morgan E. Park, identified by docket number and title, The purpose of this survey effort is to Alternate OSD Federal Register Liaison by any of the following methods: gather information that will support Officer, Department of Defense. • Federal eRulemaking Portal: http:// development of a water-based [FR Doc. 2018–23675 Filed 10–29–18; 8:45 am] www.regulations.gov. Follow the recreational demand model for the instructions for submitting comments. Columbia River Basin in Washington, BILLING CODE 5001–06–P • Mail: Department of Defense, Office Oregon, Idaho, and western Montana. of the Chief Management Officer, The proposed design involves a mail DEPARTMENT OF DEFENSE Directorate for Oversight and survey for preliminary screening to Compliance, 4800 Mark Center Drive, identify eligible recreators, followed by Office of the Secretary Mailbox #24 Suite 08D09, Alexandria, a telephone survey of eligible recreators VA 22350–1700. to collect data on recreational trips and [Transmittal No. 18–34] Instructions: All submissions received activities within the region. The model Arms Sales Notification must include the agency name, docket will be used to evaluate recreational number, and title for this Federal impacts associated with alternatives AGENCY: Defense Security Cooperation Register document. The general policy identified within the CRSO EIS. Agency, Department of Defense.

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ACTION: Arms sales notice. SUPPLEMENTARY INFORMATION: This 18–34 with attached Policy Justification 36(b)(1) arms sales notification is and Sensitivity of Technology. SUMMARY: The Department of Defense is published to fulfill the requirements of publishing the unclassified text of an Dated: October 24, 2018. section 155 of Public Law 104–164 arms sales notification. Aaron T. Siegel, dated July 21, 1996. The following is a FOR FURTHER INFORMATION CONTACT: copy of a letter to the Speaker of the Alternate OSD Federal Register Liaison DSCA at dsca.ncr.lmo.mbx.info@ Officer, Department of Defense. House of Representatives, Transmittal mail.mil or (703) 697–9709.

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Transmittal No. 18–34 Aircraft, which includes: nine (9) Joint Electronics; Lockheed Martin; Notice of Proposed Issuance of Letter of Multifunctional Information Martin Baker; Northrop Grumman Corp, Offer Pursuant to Section 36(b)(1) of the Distribution System Joint Tactical Radio Falls Church, VA; Pole Zero, Cincinnati, Arms Export Control Act, as amended Systems 5 (MIDS JTRS 5) (one (1) for OH; Raytheon, Waltham, MA; Raytheon, each aircraft, one (1) for the Tactical UK; Rockwell Collins, Cedar Rapids, IA; (i) Prospective Purchaser: Republic of Operations Center (TOC) and two (2) as Spirit Aero, Wichita, KS; Symmetries Korea spares); fourteen (14) LN–251 with Telephonics, Farmingdale, NY; Terma, Major Defense Equipment * $1.54 billion Embedded Global Positioning Systems Arlington, VA; Viking; and WESCAM. Other ...... $ .56 billion (GPS)/Inertial Navigations Systems The purchaser typically requests (EGIs) (two (2) for each aircraft and two offsets. There are no known offset TOTAL ...... $2.10 billion (2) as spares); and forty-two (42) AN/ agreements proposed in connection (iii) Description and Quantity or AAR–54 Missile Warning Sensors (six with this potential sale. Any offset Quantities of Articles or Services under (6) for each aircraft and six (6) as agreement will be defined in Consideration for Purchase: spares). Also included are commercial negotiations between the Purchaser and Major Defense Equipment (MDE): engines; Tactical Open Mission the prime contractor. Six (6) P–8A Patrol Aircraft, which Software (TOMS); Electro-Optical (E.O.) Implementation of this proposed sale includes: and Infrared (IO) MX–20HD; AN/AAQ– will require approximately three (3) U.S. Nine (9) Multifunctional Information 2(V)1 Acoustic System; AN/APY–10 government personnel and ten (10) Distribution System Joint Tactical Radar; ALQ–240 Electronic Support contractor personnel to support the Radio System 5 (MIDS JTRS) (one (1) Measures; AN/ALE–47 Counter program in country. for each aircraft, one (1) for the Measures Dispensing System; support There will be no adverse impact on Tactical Operations Center, and two equipment; operation support systems; U.S. defense readiness as a result of this (2) spares) maintenance trainer/classrooms; proposed sale. Forty-two (42) AN/AAR–54 Missile publications; software, engineering, and Transmittal No. 18–34 Warning Sensors (six (6) for each logistics technical assistance; foreign aircraft and six (6) spares) liaison officer support; contractor Notice of Proposed Issuance of Letter of Fourteen (14) LN–251 with Embedded engineering technical services; repair Offer Pursuant to Section 36(b)(1) of the Global Positioning Systems (GPS)/ and return; transportation; aircraft ferry; Arms Export Control Act and other associated training, logistics, Inertial Navigations Systems (EGIs) Annex (two (2) for each aircraft and two (2) support equipment and services. The spares) total estimated program cost is $2.1 Item No. vii billion. Non-MDE includes: (vii) Sensitivity of Technology: The ROK is one of the closest allies Commercial engines; Tactical Open in the INDOPACOM Theater. The 1. The P–8A aircraft is a militarized Mission Software (TOMS); Electro- proposed sale will support U.S. foreign version of the Boeing 737–800 Next Optical (E.O.) and Infrared (IR) MX– policy and national security objectives Generation (NG) commercial aircraft. 20HD; AN/AAQ–2(V)1 Acoustic by enhancing Korea’s naval capabilities The P–8A is replacing the P–3C as the System; AN/APY–10 Radar; ALQ–240 to provide national defense and Navy’s long-range Anti-Submarine Electronic Support Measures; AN/ALE– significantly contribute to coalition Warfare (ASW), Anti-Surface Warfare 47 Counter Measures Dispensing operations. (ASuW), Intelligence, Surveillance and System; support equipment; operation The ROK procured and has operated Reconnaissance (ISR) aircraft. The support systems; maintenance trainer/ U.S.-produced P–3 Maritime overall highest classification of the P– classrooms; publications; software, Surveillance Aircraft (MSA) for over 25 8A weapon system is SECRET. The P– engineering, and logistics technical years, providing interoperability and 8A mission systems hardware is largely assistance; foreign Liaison officer critical capabilities to coalition UNCLASSIFIED, while individual support, contractor engineering maritime operations. The ROK has software elements (mission systems, technical services; repair and return; maintained a close MSA acquisition and acoustics, ESM, EWSP, etc.) are transportation; aircraft ferry; and other sustainment relationship with the U.S. classified up to SECRET. associated training, logistics, support Navy over that period. The proposed 2. P–8A mission systems include: equipment and services. sale will allow the ROK to modernize a. Tactical Open Mission Software (iv) Military Department: Navy (KS– and sustain its MSA capability for the (TOMS). TOMS functions include P–SEJ) next 30 years. As a long-time P–3 environment planning, tactical aids, (v) Prior Related Cases, if any: N/A operator, the ROK will have no weapons planning aids, and data (vi) Sales Commission, Fee, etc., Paid, difficulty transitioning its MSA force to correlation. TOMS includes an Offered, or Agreed to be Paid: None P–8A. algorithm for track fusion which (vii) Sensitivity of Technology The proposed sale of this equipment automatically correlates tracks produced Contained in the Defense Article or and support does not alter the basic by on board and off board sensors. Defense Services Proposed to be Sold: military balance in the region. b. Electro-Optical (E.O.) and Infrared See Annex Attached The prime contractor will be The (IR) MX–20HD. The E.O./IR system (viii)Date Report Delivered to Boeing Company, Seattle, WA. processes visible E.O. and IR spectrum Congress: September 13, 2018 Additional contractors include: ASEC; to detect and image objects. * As defined in Section 47(6) of the Air Cruisers Co LLC; Arnprior c. AN/AAQ–2(V)1 Acoustic System. Arms Export Control Act. Aerospace, Canada; AVOX Zodiac The Acoustic sensor system is POLICY JUSTIFICATION Aerospace; BAE; Canadian Commercial integrated within the mission system as Corporation (CCC)/EMS; Compass; the primary sensor or the aircraft ASW Korea—P–8A Aircraft and Associated David Clark; DLS or ViaSat, Carlsbad, missions. The system has multi-static Support CA; DRS; Exelis, McLean, VA; GC active coherent (MAC) 64 sonobuoy The Republic of Korea (ROK) has Micro, Petaluma, CA; General processing capability and acoustic requested to buy six (6) P–8A Patrol Dynamics; General Electric, UK; Harris; sensor prediction tools.

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d. AN/APY–10 Radar. The aircraft result in the development of FOR FURTHER INFORMATION CONTACT: For radar is a direct derivative of the legacy countermeasures or equivalent systems, specific questions related to collection AN/APS–137(V) installed in the P–3C. which could reduce system activities, please contact Beth The radar capabilities include GPS effectiveness or be used in the Grebeldinger, 202–377–4018. Selective Availability Anti-Spoofing development of a system with similar Module (SAASM), SAR and ISAR advanced capabilities. SUPPLEMENTARY INFORMATION: The imagery resolutions, and periscope 4. A determination has been made Department of Education (ED), in detection mode. that the recipient government can accordance with the Paperwork e. ALQ–240 Electronic Support provide substantially the same degree of Reduction Act of 1995 (PRA) (44 U.S.C. Measures (ESM). This system provides protection for the technology being 3506(c)(2)(A)), provides the general real time capability for the automatic released as the U.S. Government. This public and Federal agencies with an detection, location, measurement, and sale is necessary in furtherance of the opportunity to comment on proposed, analysis of RF-signals and modes. Real U.S. foreign policy and national security revised, and continuing collections of time results are compared with a library objectives outlined in the Policy information. This helps the Department of known emitters to perform emitter Justification. assess the impact of its information classification. 5. All defense articles and services collection requirements and minimize f. Electronic Warfare Self Protection listed in this transmittal have been the public’s reporting burden. It also (EWSP). The P–8A aircraft EWSP authorized for release and export to the helps the public understand the consists of the ALQ–213 Electronic Republic of Korea. Department’s information collection Warfare Management System (EWMS), requirements and provide the requested AN/AAR–54 Missile Warning Sensors [FR Doc. 2018–23612 Filed 10–29–18; 8:45 am] BILLING CODE 5001–06–P data in the desired format. ED is and AN/ALE–47 Countermeasures soliciting comments on the proposed Dispensing System (CMDS). The EWSP information collection request (ICR) that includes threat information. Technical is described below. The Department of data and documentation to be provided DEPARTMENT OF EDUCATION are UNCLASSIFIED. Education is especially interested in g. Multifunctional Information [Docket No. ED–2018–ICCD–0089] public comment addressing the Distribution System-Joint Tactical Radio following issues: (1) Is this collection System 5 (MIDS JTRS 5) is an advanced Agency Information Collection necessary to the proper functions of the Link-16 Command, Control, Activities; Submission to the Office of Department; (2) will this information be Communications, and Intelligence (C3I) Management and Budget for Review processed and used in a timely manner; system incorporating high-capacity, and Approval; Comment Request; (3) is the estimate of burden accurate; jam-resistant, digital communication Health Education Assistance Loan (4) how might the Department enhance links for exchange of near real-time (HEAL) Program: Forms the quality, utility, and clarity of the tactical information, including both data information to be collected; and (5) how AGENCY: Federal Student Aid (FSA), and vice, among air, ground, and sea Department of Education (ED). might the Department minimize the elements. The MIDS JTRS 5 terminal burden of this collection on the ACTION: Notice. hardware, publications, performance respondents, including through the use specifications, operational capability, SUMMARY: In accordance with the of information technology. Please note parameters, vulnerabilities to Paperwork Reduction Act of 1995, ED is that written comments received in countermeasures, and software proposing an extension of an existing response to this notice will be documentation are classified information collection. considered public records. CONFIDENTIAL. The classified information to be provided consists of DATES: Interested persons are invited to Title of Collection: Health Education that which is necessary for the submit comments on or before Assistance Loan (HEAL) Program: operation, maintenance, and repair November 29, 2018. Forms. (through intermediate level) of the data ADDRESSES: To access and review all the OMB Control Number: 1845–0128. link terminal, installed systems, and documents related to the information Type of Review: An extension of an related software. collection listed in this notice, please existing information collection. h. The Embedded Global Positioning use http://www.regulations.gov by System (EGI)-Inertial Navigation System searching the Docket ID number ED– Respondents/Affected Public: Private (INS)/LN–251 is a sensor that combines 2018–ICCD–0089. Comments submitted Sector; Individuals or Households. Global Positioning System (GPS) and in response to this notice should be Total Estimated Number of Annual inertial sensor inputs to provide submitted electronically through the Responses: 69. accurate location information for Federal eRulemaking Portal at http:// Total Estimated Number of Annual navigation and targeting. The EGI–INS/ www.regulations.gov by selecting the Burden Hours: 11. LN–251 is UNCLASSIFIED. The GPS Docket ID number or via postal mail, cryptovariable keys needed for highest commercial delivery, or hand delivery. Abstract: The HEAL forms are GPS accuracy are classified up to Please note that comments submitted by required for lenders to make application SECRET. fax or email and those submitted after to the HEAL insurance program, to 3. If a technologically advanced the comment period will not be report accurately and timely on loan adversary were to obtain access of the accepted. Written requests for actions, including transfer of loans to a P–8A specific hardware and software information or comments submitted by secondary agent, and to establish the elements, systems could be reverse postal mail or delivery should be repayment status of borrowers who engineering to discover USN addressed to the Director of the qualify for deferment of payments using capabilities and tactics. The Information Collection Clearance form 508. The reports assist in the consequences of the loss of this Division, U.S. Department of Education, diligent administration of the HEAL technology, to a technologically 550 12th Street SW, PCP, Room 9086, program, protecting the financial advanced or competent adversary, could Washington, DC 20202–0023. interest of the federal government.

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Dated: October 25, 2018. collection requirements and minimize HEA program funds, do not incur Kate Mullan, the public’s reporting burden. It also unreasonable and uncommon financial Acting Director, Information Collection helps the public understand the account fees on these title IV funds and Clearance Division, Office of the Chief Privacy Department’s information collection are not led to believe that they must Officer, Office of Management. requirements and provide the requested open a particular financial account to [FR Doc. 2018–23664 Filed 10–29–18; 8:45 am] data in the desired format. ED is receive their Federal student aid. BILLING CODE 4000–01–P soliciting comments on the proposed Dated: October 25, 2018 information collection request (ICR) that Kate Mullan, is described below. The Department of DEPARTMENT OF EDUCATION Education is especially interested in Acting Director, Information Collection Clearance Division, Office of the Chief Privacy public comment addressing the [Docket No.: ED–2018–ICCD–0091] Officer, Office of Management. following issues: (1) Is this collection [FR Doc. 2018–23666 Filed 10–29–18; 8:45 am] necessary to the proper functions of the Agency Information Collection BILLING CODE 4000–01–P Activities; Submission to the Office of Department; (2) will this information be Management and Budget for Review processed and used in a timely manner; and Approval; Comment Request; (3) is the estimate of burden accurate; DEPARTMENT OF EDUCATION Student Assistance General (4) how might the Department enhance [Docket No.: ED–2018–ICCD–0090] Provisions—Subpart K—Cash the quality, utility, and clarity of the Management information to be collected; and (5) how might the Department minimize the Agency Information Collection AGENCY: Federal Student Aid (FSA), burden of this collection on the Activities; Submission to the Office of Department of Education (ED). respondents, including through the use Management and Budget for Review and Approval; Comment Request; ACTION: Notice. of information technology. Please note that written comments received in Income Based Repayment— SUMMARY: In accordance with the response to this notice will be Notifications Paperwork Reduction Act of 1995, ED is considered public records. AGENCY: Federal Student Aid (FSA), proposing an extension of an existing Title of Collection: Student Assistance Department of Education (ED). information collection. General Provisions—Subpart K—Cash ACTION: Notice. DATES: Interested persons are invited to Management. submit comments on or before OMB Control Number: 1845–0106. SUMMARY: In accordance with the November 29, 2018. Type of Review: An extension of an Paperwork Reduction Act of 1995, ED is ADDRESSES: To access and review all the existing information collection. proposing an extension of an existing documents related to the information Respondents/Affected Public: Private information collection. Sector; State, Local, and Tribal collection listed in this notice, please DATES: Interested persons are invited to use http://www.regulations.gov by Governments; Individuals or submit comments on or before searching the Docket ID number ED– Households. November 29, 2018. Total Estimated Number of Annual 2018–ICCD–0091. Comments submitted Responses: 3,037,182. ADDRESSES: To access and review all the in response to this notice should be Total Estimated Number of Annual documents related to the information submitted electronically through the Burden Hours: 916,357. collection listed in this notice, please Federal eRulemaking Portal at http:// Abstract: The Department of use http://www.regulations.gov by www.regulations.gov by selecting the Education (the Department) is searching the Docket ID number ED– Docket ID number or via postal mail, requesting an extension of the 2018–ICCD–0090. Comments submitted commercial delivery, or hand delivery. information collection for the in response to this notice should be Please note that comments submitted by requirements that are contained in the submitted electronically through the fax or email and those submitted after regulations § 668.164—Disbursing Federal eRulemaking Portal at http:// the comment period will not be funds. The regulations require that an www.regulations.gov by selecting the accepted. Written requests for institution that makes direct payments Docket ID number or via postal mail, information or comments submitted by to a student or parent by electronic commercial delivery, or hand delivery. postal mail or delivery should be funds transfer (EFT) and that chooses to Please note that comments submitted by addressed to the Director of the enter into an arrangement described in fax or email and those submitted after Information Collection Clearance 668.164(e) or (f), including an the comment period will not be Division, U.S. Department of Education, institution that uses a third-party accepted. Written requests for 550 12th Street SW, PCP, Room 9086, servicer to make those payments, must information or comments submitted by Washington, DC 20202–0023. establish a selection process under postal mail or delivery should be FOR FURTHER INFORMATION CONTACT: For which the student chooses one of addressed to the Director of the specific questions related to collection several options for receiving those Title Information Collection Clearance activities, please contact Beth IV, HEA fund payments. The Division, U.S. Department of Education, Grebeldinger, 202–377–4018. Department amended the Student 550 12th Street SW, PCP, Room 9086, SUPPLEMENTARY INFORMATION: The Assistance General Provisions Washington, DC 20202–0023. Department of Education (ED), in regulations issued under the Higher FOR FURTHER INFORMATION CONTACT: For accordance with the Paperwork Education Act of 1965, as amended specific questions related to collection Reduction Act of 1995 (PRA) (44 U.S.C. (HEA), to implement the changes made activities, please contact Beth 3506(c)(2)(A)), provides the general to the Student Assistance General Grebeldinger, 202–377–4018. public and Federal agencies with an Provisions regulations—Subpart K— SUPPLEMENTARY INFORMATION: The opportunity to comment on proposed, Cash Management § 668.164— Department of Education (ED), in revised, and continuing collections of Disbursing funds. These regulations are accordance with the Paperwork information. This helps the Department intended to ensure students and parents Reduction Act of 1995 (PRA) (44 U.S.C. assess the impact of its information have convenient access to their Title IV, 3506(c)(2)(A)), provides the general

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public and Federal agencies with an Dated: October 25, 2018. collection requirements and minimize opportunity to comment on proposed, Kate Mullan, the public’s reporting burden. It also revised, and continuing collections of Acting Director, Information Collection helps the public understand the information. This helps the Department Clearance Division, Office of the Chief Privacy Department’s information collection assess the impact of its information Officer, Office of Management. requirements and provide the requested collection requirements and minimize [FR Doc. 2018–23665 Filed 10–29–18; 8:45 am] data in the desired format. ED is the public’s reporting burden. It also BILLING CODE 4000–01–P soliciting comments on the proposed helps the public understand the information collection request (ICR) that Department’s information collection is described below. The Department of DEPARTMENT OF EDUCATION requirements and provide the requested Education is especially interested in data in the desired format. ED is [Docket No. ED–2018–ICCD–0114] public comment addressing the soliciting comments on the proposed following issues: (1) Is this collection necessary to the proper functions of the information collection request (ICR) that Agency Information Collection Department; (2) will this information be is described below. The Department of Activities; Comment Request; FY 2018 processed and used in a timely manner; Education is especially interested in Child Care Access Means Parents in School Annual Performance Report (3) is the estimate of burden accurate; public comment addressing the Package 84.335A (4) how might the Department enhance following issues: (1) Is this collection the quality, utility, and clarity of the necessary to the proper functions of the AGENCY: Office of Postsecondary information to be collected; and (5) how Department; (2) will this information be Education (OPE), Department of might the Department minimize the processed and used in a timely manner; Education (ED). burden of this collection on the (3) is the estimate of burden accurate; ACTION: Notice. respondents, including through the use (4) how might the Department enhance of information technology. Please note SUMMARY: In accordance with the the quality, utility, and clarity of the that written comments received in Paperwork Reduction Act of 1995, ED is information to be collected; and (5) how response to this notice will be proposing a reinstatement of a might the Department minimize the considered public records. previously approved information burden of this collection on the Title of Collection: FY 2018 Child collection. respondents, including through the use Care Access Means Parents in School of information technology. Please note DATES: Interested persons are invited to Annual Performance Report Package that written comments received in submit comments on or before 84.335A. response to this notice will be December 31, 2018. OMB Control Number: 1840–0763. considered public records. ADDRESSES: To access and review all the Type of Review: A reinstatement of a documents related to the information previously approved information Title of Collection: Income Based collection listed in this notice, please collection. Repayment—Notifications. use http://www.regulations.gov by Respondents/Affected Public: Private OMB Control Number: 1845–0114. searching the Docket ID number ED– Sector. Type of Review: An extension of an 2018–ICCD–0114. Comments submitted Total Estimated Number of Annual existing information collection. in response to this notice should be Responses: 350. submitted electronically through the Total Estimated Number of Annual Respondents/Affected Public: State, Federal eRulemaking Portal at http:// Burden Hours: 9,800. Local, and Tribal Governments; Private www.regulations.gov by selecting the Abstract: The Child Care Access Sector. Docket ID number or via postal mail, Means Parents In School (CCAMPIS) Total Estimated Number of Annual commercial delivery, or hand delivery. annual performance reports are used to Responses: 958,240. Please note that comments submitted by collect programmatic data for purposes Total Estimated Number of Annual fax or email and those submitted after of annual reporting; budget submissions Burden Hours: 76,665. the comment period will not be to OMB; Congressional hearings and accepted. Written requests for testimonials; Congressional inquiries; Abstract: The Higher Education Act of information or comments submitted by and responding to inquiries from higher 1965, as amended (HEA), established postal mail or delivery should be education interest groups and the the Federal Family Education Loan addressed to the Director of the general public. (FFEL) Program under Title IV, Part B. Information Collection Clearance Dated: October 25, 2018. Section 493C [20 U.S.C. 1098e] of the Division, U.S. Department of Education, Kate Mullan, HEA authorizes income based 550 12th Street SW, PCP, Room 9086, repayment for Part B borrowers who Washington, DC 20202–0023. Acting Director, Information Collection Clearance Division, Office of the Chief Privacy have a partial financial hardship. The FOR FURTHER INFORMATION CONTACT: For Officer, Office of Management. regulations in 34 CFR 682.215(e)(2) specific questions related to collection [FR Doc. 2018–23663 Filed 10–29–18; 8:45 am] require notifications to borrowers from activities, please contact Harold Wells, BILLING CODE 4000–01–P the loan holders once a borrower 202–453–6131. establishes a partial financial hardship SUPPLEMENTARY INFORMATION: The and is placed in an income based Department of Education (ED), in repayment (IBR) plan by the loan accordance with the Paperwork DEPARTMENT OF ENERGY holder. The regulations identify Reduction Act of 1995 (PRA) (44 U.S.C. Agency Information Collection information the loan holder must 3506(c)(2)(A)), provides the general Extension provide to the borrower to continue to public and Federal agencies with an participate in an IBR plan. This is a opportunity to comment on proposed, AGENCY: U.S. Department of Energy. revised, and continuing collections of request for extension of the current ACTION: Notice and request for information. This helps the Department information collection 1845–0114. comments. assess the impact of its information

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SUMMARY: The Department of Energy Signed in Washington, DC on October 23, Mail Stop GC–33, Forrestal Building, (DOE), pursuant to the Paperwork 2018. 1000 Independence Avenue SW, Reduction Act of 1995, intends to Theodore J. Garrish, Washington, DC 20585–0103. extend for three years, an information Acting General Counsel, United States Telephone: (202) 586–9496. Email: collection request with the Office of Department of Energy. [email protected]. Management and Budget (OMB). [FR Doc. 2018–23668 Filed 10–29–18; 8:45 am] SUPPLEMENTARY INFORMATION: In DATES: Comments regarding this BILLING CODE 6450–01–P accordance with Title 10 of the Code of proposed information collection must Federal Regulations (10 CFR be received on or before December 31, DEPARTMENT OF ENERGY 431.401(f)(2)), DOE gives notice of the 2018. If you anticipate difficulty in issuance of its Decision and Order as set submitting comments within that [Case Number 2017–007; EERE–2017–BT– forth below. The Decision and Order period, contact the person listed below WAV–0041] grants AHT a waiver from the applicable as soon as possible. test procedure in 10 CFR part 431, Energy Conservation Program: ADDRESSES: Written comments may be subpart C, appendix B (‘‘Appendix B’’) Decision and Order Granting a Waiver sent to Eric Mulch at 1000 for specified basic models of to AHT Cooling Systems GmbH and Independence Ave. SW, Washington, commercial refrigeration equipment, AHT Cooling Systems USA Inc. From DC 20585 or by email at eric.mulch@ provided that AHT tests and rates such the Department of Energy Commercial hq.doe.gov. equipment using the alternate test Refrigerator, Freezer, and Refrigerator- FOR FURTHER INFORMATION CONTACT: procedure specified in the Decision and Eric Freezer Test Procedure F. Mulch, Attorney-Adviser, at (202) Order. AHT’s representations 287–5746, or via email at eric.mulch@ AGENCY: Office of Energy Efficiency and concerning the energy consumption of hq.doe.gov. Renewable Energy, Department of the specified basic models must be SUPPLEMENTARY INFORMATION: Comments Energy. based on testing according to the are invited on: (a) Whether the extended ACTION: Notice of decision and order. provisions and restrictions in the collection of information is necessary alternate test procedure set forth in the SUMMARY: The U.S. Department of Decision and Order, and the for the proper performance of the Energy (‘‘DOE’’) gives notice of a functions of the agency, including representations must fairly disclose the Decision and Order (Case Number whether the information shall have test results. Distributors, retailers, and 2017–007) that grants AHT Cooling practical utility; (b) the accuracy of the private labelers are held to the same Systems GmbH and AHT Cooling agency’s estimate of the burden of the requirements when making Systems USA Inc. (‘‘AHT’’) a waiver proposed collection of information, representations regarding the energy from specified portions of the DOE test including the validity of the consumption of this equipment. (42 procedure for determining the energy methodology and assumptions used; (c) U.S.C. 6314(d)) consumption of specified commercial ways to enhance the quality, utility, and Consistent with 10 CFR 431.401(j), refrigerators, freezers, and refrigerator- clarity of the information to be not later than December 31, 2018, any freezers (collectively ‘‘commercial collected; and (d) ways to minimize the manufacturer currently distributing in burden of the collection of information refrigeration equipment’’) basic models. commerce in the United States on respondents, including through the Under the Decision and Order, AHT is equipment employing a technology or use of automated collection techniques required to test and rate the specified characteristic that results in the same or other forms of information basic models of its commercial need for a waiver from the applicable technology. This information collection refrigeration equipment in accordance test procedure must submit a petition request contains: (1) OMB No. 1910– with the alternate test procedure for waiver. Manufacturers not currently 5115; (2) Information Collection Request specified in the Decision and Order. distributing such equipment in Title: Contractor Legal Management DATES: The Decision and Order is commerce in the United States must Requirements; (3) Type of Review: effective on October 30, 2018. The petition for and be granted a waiver Extension; (4) Purpose: The information Decision and Order will terminate upon prior to the distribution in commerce of collection to be extended has been and the compliance date of any future that equipment in the United States. will be used to form the basis for DOE amendment to the test procedure for Manufacturers may also submit a actions on requests from the contractors commercial refrigeration equipment request for interim waiver pursuant to for reimbursement of litigation and located at 10 CFR part 431, subpart C, the requirements of 10 CFR 431.401. other legal expenses. The information appendix B that addresses the issues presented in this waiver. At such time, Signed in Washington, DC, on October 16, collected related to annual legal budget, 2018. staffing and resource plans, and AHT must use the relevant test procedure for this equipment for any Kathleen B. Hogan, initiation or settlement of defensive or Deputy Assistant Secretary for Energy offensive litigation is and will be testing to demonstrate compliance with standards, and any other representations Efficiency, Energy Efficiency and Renewable similarly used; (5) Annual Estimated Energy. Number of Respondents: 45; (6) Annual of energy use. Estimated Number of Total Responses: FOR FURTHER INFORMATION CONTACT: Case #2017–007 154; (7) Annual Estimated Number of Ms. Lucy deButts, U.S. Department of Decision and Order Burden Hours: 1,150; (8) Annual Energy, Office of Energy Efficiency Estimated Reporting and Recordkeeping and Renewable Energy, Building I. Background and Authority Cost Burden: 0. Technologies Office, EE–5B, 1000 The Energy Policy and Conservation Independence Avenue SW, Statutory Authority: Section 161 of the Act of 1975 (‘‘EPCA’’),1 Public Law 94– Atomic Energy Act of 1954, 42 U.S.C. 2201, Washington, DC 20585–0121. Telephone: (202) 287–1604. Email: the Department of Energy Organization Act, 1 _ _ All references to EPCA in this document refer 42 U.S.C 7101, et seq., and the National AS Waiver [email protected]. to the statute as amended through the EPS Nuclear Security Administration Act, 50 Mr. Pete Cochran, U.S. Department of Improvement Act of 2017, Public Law 115–115 U.S.C. 2401, et seq. Energy, Office of the General Counsel, (January 12, 2018).

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163 (42 U.S.C. 6291–6317, as codified), The wavier process also provides that commercial freezer basic models. DOE’s among other things, authorizes the U.S. DOE may grant an interim waiver if it test procedure requires beginning the Department of Energy (‘‘DOE’’) to appears likely that the petition for test period at the start of a defrost cycle regulate the energy efficiency of a waiver will be granted and/or if DOE and recording data for 24 hours, and number of consumer products and determines that it would be desirable for initiating a door-opening period 3 hours industrial equipment. Title III, Part C 2 public policy reasons to grant after the start of a defrost cycle. As such, of EPCA established the Energy immediate relief pending a for the specified basic models, which do Conservation Program for Certain determination on the underlying not defrost, there is no defined start to Industrial Equipment, which sets forth a petition for waiver. 10 CFR either the test period or the door- variety of provisions designed to 431.401(e)(2). Within one year of opening period under DOE’s test improve energy efficiency for certain issuance of an interim waiver, DOE will procedure. Based on review of the types of industrial equipment. This either: (i) Publish in the Federal application for an interim waiver, DOE equipment includes commercial Register a determination on the petition determined that the alternate test refrigerators, freezers, and refrigerator- for waiver; or (ii) publish in the Federal procedure that AHT suggested freezers (collectively ‘‘commercial Register a new or amended test appropriately reflects the energy refrigeration equipment’’), the focus of procedure that addresses the issues consumption of and is appropriate for this document. (42 U.S.C. 6311(1)(E)) presented in the waiver. 10 CFR the commercial freezer basic models EPCA also requires the Secretary of 431.401(h)(1). When DOE amends the identified in AHT’s petition for waiver. Energy to prescribe test procedures that test procedure to address the issues In the Notice of Petition for Waiver, are reasonably designed to produce presented in a waiver, the waiver will DOE also solicited comments from results that measure energy efficiency, automatically terminate on the date on interested parties on all aspects of the energy use, or estimated operating costs which use of that test procedure is petition and the specified alternate test during a representative average-use required to demonstrate compliance. 10 procedure, which was consistent with cycle, and that are not unduly CFR 431.401(h)(2). AHT’s requested alternate approach. burdensome to conduct. (42 U.S.C. DOE received no comments in response II. AHT’s Petition for Waiver: 6314(a)(2)) The test procedure for to the Notice of Petition for Waiver. Assertions and Determinations commercial refrigeration equipment is For the reasons explained here and in contained in 10 CFR part 431, subpart By letter dated May 16, 2017, AHT the Notice of Petition for Waiver, DOE C, appendix B. submitted a petition for waiver and an understands that absent a waiver, the commercial freezer basic models DOE’s regulations set forth at 10 CFR application for interim waiver for specified basic models of commercial identified by AHT in its petition contain 431.401 contain provisions that allow a design characteristic—lack of a defrost an interested person to seek a waiver refrigeration equipment that are required to be tested using the cycle when operated in freezer mode— from the test procedure requirements for that prevents testing and rating such a particular basic model when the commercial refrigeration equipment test procedure at 10 CFR part 431, subpart models on a basis representative of their petitioner’s basic model for which the true energy consumption characteristics. petition for waiver was submitted C, appendix B.3 AHT stated that the basic models listed in the petition do DOE has reviewed the recommended contains one or more design procedure suggested by AHT and characteristics that either (1) prevent not have a defrost cycle when operated in freezer mode, and therefore cannot be concludes that it will allow for the testing according to the prescribed test accurate measurement of the energy use procedure, or (2) cause the prescribed tested under Appendix B, which references defrosts for the start of the of the equipment, while alleviating the test procedures to evaluate the basic testing problems associated with AHT’s test period and door-opening period. model in a manner so unrepresentative implementation of DOE’s applicable On June 4, 2018, DOE published a of its true energy consumption commercial refrigeration equipment test notice that announced its receipt of the characteristics as to provide materially procedure for the specified basic petition for waiver and granted AHT an inaccurate comparative data. 10 CFR models. Thus, DOE is requiring that interim waiver. 83 FR 25658. (‘‘Notice of 431.401(a)(1). A petitioner must include AHT test and rate the commercial Petition for Waiver’’). In the Notice of in its petition any alternate test freezer basic models for which it has Petition for Waiver, DOE presented procedures known to the petitioner to requested a waiver according to the AHT’s claim that its specified basic evaluate the basic model in a manner alternate test procedure specified in this models cannot be tested according to representative of its energy Decision and Order, which is identical consumption characteristics. 10 CFR Appendix B due to their lack of defrost to the procedure provided in the interim 431.401(b)(1)(iii). when operated in freezer mode. AHT waiver. DOE may grant a waiver subject to requested an alternate test procedure, This Decision and Order is applicable conditions, including adherence to which would test the specified only to the basic models listed within it alternate test procedures. 10 CFR commercial freezer basic models and does not extend to any other basic 431.401(f)(2). As soon as practicable according to appendix B, but with the models. DOE evaluates and grants after the granting of any waiver, DOE test period starting after the unit waivers for only those basic models will publish in the Federal Register a achieves steady state conditions and the specifically set out in the petition, not notice of proposed rulemaking to amend door-opening period starting 3 hours future models that may be manufactured its regulations so as to eliminate any after the start of the test period. by the petitioner. AHT may request that need for the continuation of such As explained in the Notice of Petition the scope of this waiver be extended to waiver. 10 CFR 431.401(l). As soon for Waiver, DOE evaluated the alternate include additional basic models that thereafter as practicable, DOE will test procedure requested by AHT, as employ the same technology as those publish in the Federal Register a final well as the operating manual for the listed in this waiver. 10 CFR 431.401(g). rule. Id. AHT may also submit another petition 3 AHT’s petition for waiver and petition for interim waiver can be found in the regulatory for waiver from the test procedure for 2 For editorial reasons, upon codification in the docket at https://www.regulations.gov/docket? additional basic models that employ a U.S. Code, Part C was redesignated as Part A–1. D=EERE-2017-BT-WAV-0041. different technology and meet the

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criteria for test procedure waivers. 10 2005, Section 3, definitions, which defines DEPARTMENT OF ENERGY CFR 431.401(a)(1). steady state as ‘‘the condition where the DOE notes that it may modify or average temperature of all test simulators Environmental Management Site- ° ° rescind the waiver at any time upon changes less than 0.2 C (0.4 F) from one 24- Specific Advisory Board, Oak Ridge DOE’s determination that the factual hour period or refrigeration cycle to the next’’ ASHRAE 72–2005, Section 3, definitions). AGENCY: basis underlying the petition for waiver Office of Environmental Additionally, the door-opening requirements Management, Department of Energy. is incorrect, or upon a determination shall be as defined in ASHRAE 72–2005 that the results from the alternate test Section 7.2, with the exception that the eight- ACTION: Notice of open meeting. procedure are unrepresentative of the hour period of door openings shall begin SUMMARY: This notice announces a basic models’ true energy consumption three hours after the start of the test. Ambient meeting of the Environmental characteristics. 10 CFR 431.401(k)(1). temperature, test simulator temperatures, and Management Site-Specific Advisory Likewise, AHT may request that DOE all other data shall be recorded at three- Board (EM SSAB), Oak Ridge. The rescind or modify the waiver if the minute intervals beginning at the start of the test and throughout the 24-hour testing Federal Advisory Committee Act company discovers an error in the period. requires that public notice of this information provided to DOE as part of meeting be announced in the Federal its petition, determines that the waiver (3) Representations. AHT may not Register. is no longer needed, or for other make representations about the energy appropriate reasons. 10 CFR use of the basic models identified in DATES: Wednesday, November 14, 2018 431.401(k)(2). paragraph (1) of this Order for 6:00 p.m. compliance, marketing, or other ADDRESSES: DOE Information Center, III. Order purposes unless the basic model has Office of Science and Technical been tested in accordance with the After careful consideration of all the Information, 1 Science.gov Way, Oak provisions set forth above and such material that was submitted by AHT in Ridge, Tennessee 37831. this matter, it is ordered that: representations fairly disclose the FOR FURTHER INFORMATION CONTACT: (1) AHT must, as of the date of results of such testing in accordance publication of this Order in the Federal with 10 CFR part 431, subpart C, Melyssa P. Noe, Alternate Deputy Register, test and rate the following appendix B and 10 CFR 429.42, as Designated Federal Officer, U.S. AHT brand commercial freezer basic specified in this Order. Department of Energy, Oak Ridge Office models (which do not have defrost cycle (4) This waiver shall remain in effect of Environmental Management (OREM), capability when operated in freezer according to the provisions of 10 CFR P.O. Box 2001, EM–942, Oak Ridge, TN mode) with the alternate test procedure 431.401. 37831. Phone (865) 241–3315; Fax (865) as set forth in paragraph (2): (5) This waiver is issued on the 241–6932; Email: Melyssa.Noe@ condition that the statements, orem.doe.gov. Or visit the website at Brand name Basic model representations, and documentation https://energy.gov/orem/services/ provided by AHT are valid. If AHT community-engagement/oak-ridge-site- AHT ...... IBIZA 100 NAM F makes any modifications to the controls specific-advisory-board. AHT ...... IBIZA 145 NAM F or capabilities (e.g., adding automatic SUPPLEMENTARY INFORMATION: AHT ...... IBIZA 210 NAM F defrost to freezer mode) of these basic AHT ...... MALTA 145 NAM F Purpose of the Board: The purpose of AHT ...... MALTA 185 NAM F models, the waiver will no longer be the Board is to make recommendations AHT ...... MANHATTAN 175 NAM F valid and AHT will either be required to DOE–EM and site management in the AHT ...... MANHATTAN 210 NAM F to use the current Federal test method areas of environmental restoration, AHT ...... MIAMI 145 NAM F or submit a new application for a test waste management, and related AHT ...... MIAMI 185 NAM F procedure waiver. DOE may revoke or activities. AHT ...... MIAMI 210 NAM F modify this waiver at any time if it Tentative Agenda: AHT ...... MIAMI 250 NAM F determines the factual basis underlying • Welcome and Announcements AHT ...... PARIS 145 NAM F • AHT ...... PARIS 185 NAM F the petition for waiver is incorrect, or Comments from the Deputy AHT ...... PARIS 210 NAM F the results from the alternate test Designated Federal Officer (DDFO) AHT ...... PARIS 250 NAM F procedure are unrepresentative of the • Comments from the DOE, Tennessee AHT ...... SYDNEY 175 NAM F basic models’ true energy consumption Department of Environment and AHT ...... SYDNEY 210 NAM F characteristics. 10 CFR 431.401(k)(1). Conservation, and Environmental AHT ...... SYDNEY 213 NAM F Likewise, AHT may request that DOE Protection Agency Liaisons AHT ...... SYDNEY 223 NAM F rescind or modify the waiver if AHT • Public Comment Period AHT ...... SYDNEY 230 NAM F • AHT ...... SYDNEY 250 NAM F discovers an error in the information Presentation: Overview of Ongoing AHT ...... SYDNEY XL175 NAM F provided to DOE as part of its petition, Efforts to Assure Sufficient Waste AHT ...... SYDNEY XL210 NAM F determines that the waiver is no longer Disposal Capacity AHT ...... SYDNEY XL250 NAM F needed, or for other appropriate reasons. • Motions/Approval of October 10, 10 CFR 431.401(k)(2). 2018 Meeting Minutes (2) The alternate test procedure for the (6) Granting of this waiver does not • Status of Outstanding AHT basic models listed in paragraph release AHT from the certification Recommendations (1) of this Order is the test procedure for requirements set forth at 10 CFR part • Alternate DDFO Report commercial refrigeration equipment 429. • Committee Reports • prescribed by DOE at 10 CFR part 431, Signed in Washington, DC, on October 16, Adjourn subpart C, appendix B, except that the 2018. Public Participation: The EM SSAB, test period shall be selected as detailed Kathleen B. Hogan, Oak Ridge, welcomes the attendance of below. All other requirements of Deputy Assistant Secretary for Energy the public at its advisory committee Appendix B and DOE’s regulations Efficiency, Energy Efficiency and Renewable meetings and will make every effort to remain applicable. Energy accommodate persons with physical The test shall begin when steady state [FR Doc. 2018–23669 Filed 10–29–18; 8:45 am] disabilities or special needs. If you conditions occur (per ASHRAE Standard 72– BILLING CODE 6450–01–P require special accommodations due to

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a disability, please contact Melyssa P. areas of environmental restoration, DEPARTMENT OF ENERGY Noe at least seven days in advance of waste management and related the meeting at the phone number listed activities. Federal Energy Regulatory Commission above. Written statements may be filed Tentative Agenda: with the Board either before or after the • meeting. Individuals who wish to make Call to Order, Introductions, Review [Docket No. EL16–120–000] oral statements pertaining to the agenda of Agenda item should contact Melyssa P. Noe at • Administrative Issues New England Power Generators, Inc. v. the address or telephone number listed • ISO New England Inc.; Notice of Filing above. Requests must be received five Public Comments (15 minutes) days prior to the meeting and reasonable • Adjourn Take notice that on October 19, 2018, ISO New England Inc. submitted tariff provision will be made to include the Breaks Taken As Appropriate. presentation in the agenda. The Deputy filing per: Refund Report to be effective Designated Federal Officer is Public Participation: The EM SSAB, N/A, pursuant to the order issued by the Paducah, welcomes the attendance of Federal Energy Regulatory Commission empowered to conduct the meeting in a 1 fashion that will facilitate the orderly the public at its advisory committee (Commission) on September 20, 2018. conduct of business. Individuals meetings and will make every effort to Any person desiring to intervene or to wishing to make public comments will accommodate persons with physical protest this filing must file in be provided a maximum of five minutes disabilities or special needs. If you accordance with Rules 211 and 214 of to present their comments. require special accommodations due to the Commission’s Rules of Practice and Minutes: Minutes will be available by a disability, please contact Jennifer Procedure (18 CFR 385.211, 385.214). writing or calling Melyssa P. Noe at the Woodard as soon as possible in advance Protests will be considered by the address and phone number listed above. of the meeting at the telephone number Commission in determining the appropriate action to be taken, but will Minutes will also be available at the listed above. Written statements may be not serve to make protestants parties to following website: https://energy.gov/ filed with the Board either before or the proceeding. Any person wishing to orem/listings/oak-ridge-site-specific- after the meeting. Individuals who wish become a party must file a notice of advisory-board-meetings. to make oral statements pertaining to intervention or motion to intervene, as Signed in Washington, DC on October 23, agenda items should contact Jennifer appropriate. Such notices, motions, or 2018. Woodard at the telephone number listed protests must be filed on or before the LaTanya Butler, above. Requests must be received as comment date. On or before the Deputy Committee Management Officer. soon as possible prior to the meeting comment date, it is not necessary to [FR Doc. 2018–23642 Filed 10–29–18; 8:45 am] and reasonable provision will be made serve motions to intervene or protests BILLING CODE 6450–01–P to include the presentation in the on persons other than the Applicant. agenda. The Deputy Designated Federal The Commission encourages Officer is empowered to conduct the electronic submission of protests and DEPARTMENT OF ENERGY meeting in a fashion that will facilitate interventions in lieu of paper using the the orderly conduct of business. ‘‘eFiling’’ link at http://www.ferc.gov. Environmental Management Site- Individuals wishing to make public Persons unable to file electronically Specific Advisory Board, Paducah comments will be provided a maximum should submit an original and 5 copies AGENCY: Office of Environmental of five minutes to present their of the protest or intervention to the Management, Department of Energy. comments. The EM SSAB, Paducah, Federal Energy Regulatory Commission, ACTION: Notice of open meeting. will hear public comments pertaining to 888 First Street NE, Washington, DC its scope (clean-up standards and 20426. SUMMARY: This notice announces a environmental restoration; waste This filing is accessible on-line at meeting of the Environmental management and disposition; http://www.ferc.gov, using the Management Site-Specific Advisory stabilization and disposition of non- ‘‘eLibrary’’ link and is available for Board (EM SSAB), Paducah. The stockpile nuclear materials; excess review in the Commission’s Public Federal Advisory Committee Act facilities; future land use and long-term Reference Room in Washington, DC. requires that public notice of this stewardship; risk assessment and There is an ‘‘eSubscription’’ link on the meeting be announced in the Federal management; and clean-up science and website that enables subscribers to Register. technology activities). Comments receive email notification when a DATES: Thursday, November 15, 2018 outside of the scope may be submitted document is added to a subscribed 6:00 p.m. via written statement as directed above. docket(s). For assistance with any FERC Online service, please email ADDRESSES: West Kentucky Community Minutes: Minutes will be available by [email protected], or call and Technical College, Emerging writing or calling Jennifer Woodard at (866) 208–3676 (toll free). For TTY, call Technology Center, 5100 Alben Barkley the address and phone number listed (202) 502–8659. Drive, Paducah, Kentucky 42001. above. Minutes will also be available at Comment Date: 5:00 p.m. Eastern FOR FURTHER INFORMATION CONTACT: the following website: https:// Time on November 9, 2018. Jennifer Woodard, Deputy Designated www.energy.gov/pppo/pgdp-cab/ Federal Officer, Department of Energy listings/meeting-materials. Dated: October 22, 2018. Paducah Site Office, Post Office Box Kimberly D. Bose, Signed in Washington, DC on October 24, 1410, MS–103, Paducah, Kentucky Secretary. 2018. 42001, (270) 441–6825. [FR Doc. 2018–23604 Filed 10–29–18; 8:45 am] LaTanya Butler, SUPPLEMENTARY INFORMATION: BILLING CODE 6717–01–P Purpose of the Board: The purpose of Deputy Committee Management Officer. [FR Doc. 2018–23643 Filed 10–29–18; 8:45 am] the Board is to make recommendations 1 New England Power Generators, Inc. v. ISO New to DOE–EM and site management in the BILLING CODE 6450–01–P England Inc., 164 FERC ¶ 61,190 (2018).

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DEPARTMENT OF ENERGY request. If no protest is filed within the Dated: October 22, 2018. time allowed therefore, the proposed Kimberly D. Bose, Federal Energy Regulatory activity shall be deemed to be Secretary. Commission authorized effective the day after the [FR Doc. 2018–23600 Filed 10–29–18; 8:45 am] [Docket No. CP19–4–000] time allowed for filing a protest. If a BILLING CODE 6717–01–P protest is filed and not withdrawn National Fuel Gas Supply Corporation; within 30 days after the allowed time Notice of Request Under Blanket for filing a protest, the instant request DEPARTMENT OF ENERGY Authorization shall be treated as an application for Federal Energy Regulatory authorization pursuant to section 7 of Take notice that on October 11, 2018, Commission National Fuel Gas Supply Corporation the NGA. (National Fuel), 6363 Main Street, Pursuant to section 157.9 of the [Docket No. AD19–4–000] Williamsville, New York 14221, filed in Commission’s rules, 18 CFR 157.9, Docket No. CP19–4–000, a Prior Notice within 90 days of this Notice the Panel Member List for Hydropower Licensing Study Dispute Resolution; Request pursuant to sections 157.205 Commission staff will either: Complete Notice Requesting Applications for and 157.216 of the Commission’s its environmental assessment (EA) and regulations under the Natural Gas Act Panel Members for Hydropower place it into the Commission’s public Licensing Study Dispute Resolution (NGA), and National Fuel’s blanket record (eLibrary) for this proceeding; or certificate issued in Docket No. CP83–4– issue a Notice of Schedule for This notice requests applications from 000, requesting authorization to plug those interested in being listed as and abandon one injection/withdrawal Environmental Review. If a Notice of potential panel members to assist in the (I/W) well (Zoar Well 804–I) and Schedule for Environmental Review is Federal Energy Regulatory abandon in place approximately 212 issued, it will indicate, among other Commission’s (Commission) study feet of 4-inch-diameter associated well milestones, the anticipated date for the line (AW 804) in the Zoar Storage Field Commission staff’s issuance of the EA dispute resolution process for the located in Eerie County, New York. for this proposal. The filing of the EA integrated licensing process (ILP) of National Fuel states elevated levels of in the Commission’s public record for hydropower projects. corrosion were found in the production this proceeding or the issuance of a Background casing of Zoar Well 804–I during Notice of Schedule for Environmental The Commission’s ILP regulations evaluations and rehabilitation would be Review will serve to notify federal and pertaining to hydroelectric licensing cost prohibitive due to the well’s state agencies of the timing for the under the Federal Power Act encourages configuration and historically low completion of all necessary reviews, and informal resolution of study volume deliverability, all as more fully the subsequent need to complete all disagreements. In cases where this is not described in the application which is on federal authorizations within 90 days of successful, a formal study dispute file with the Commission and open to the date of issuance of the Commission resolution process is available for state public inspection. The filing may also staff’s EA. and federal agencies or Indian tribes be viewed on the web at http:// with mandatory conditioning www.ferc.gov using the ‘‘eLibrary’’ link. Persons who wish to comment only authority.1 Enter the docket number excluding the on the environmental review of this The ILP provides that the disputed last three digits in the docket number project should submit an original and study must be submitted to a dispute field to access the document. For two copies of their comments to the resolution panel consisting of a person assistance, contact FERC at Secretary of the Commission. from Commission staff, a person from [email protected] or call Environmental commenters will be the agency or Indian tribe referring the toll-free, (866) 208–3676 or TTY, (202) placed on the Commission’s dispute to the Commission, and a third 502–8659. environmental mailing list and will be Any questions regarding this prior notified of any meetings associated with person selected by the other two notice should be directed to Alice A. the Commission’s environmental review panelists from a pre-established list of persons with expertise in the disputed Curtiss, Deputy General Counsel, process. Environmental commenters resource area.2 The third panel member National Fuel Gas Supply Corporation, will not be required to serve copies of (TPM) will serve without compensation, 6363 Main Street, Williamsville, New filed documents on all other parties. York 14221, by telephone at (716) 857– except for certain allowable travel However, the non-party commenters expenses to be borne by the Commission 7075, by fax at (716) 857–7206, or by will not receive copies of all documents email at [email protected] or (41 CFR part 301). filed by other parties or issued by the The role of the panel members is to Matthew J. Luzi, Regulatory Analyst II, Commission and will not have the right National Fuel Gas Supply Corporation, make a finding, with respect to each to seek court review of the disputed study request, on the extent to 6363 Main Street, Williamsville, New Commission’s final order. York 14221, by telephone (716) 857– which each study criteria set forth in the 3 7813, by fax (716) 857–7206, or by email The Commission strongly encourages regulations is or is not met, and why. at [email protected]. electronic filings of comments, protests, The panel will then make a Any person or the Commission’s staff and interventions in lieu of paper using recommendation to the Director of the may, within 60 days after issuance of the ‘‘eFiling’’ link at http:// Office of Energy Projects based on the the instant notice by the Commission, www.ferc.gov. Persons unable to file panel’s findings. file pursuant to Rule 214 of the electronically should submit an original Commission’s Procedural Rules (18 CFR and 3 copies of the protest or 1 See 5.14 of the final rule at https:// www.ferc.gov/industries/hydropower/indus-act/ 385.214) a motion to intervene or notice intervention to the Federal Energy order-2002.asp. of intervention and pursuant to section Regulatory Commission, 888 First Street 2 These persons must not be otherwise involved 157.205 of the regulations under the NE, Washington, DC 20426. with the proceeding. NGA (18 CFR 157.205), a protest to the 3 See 5.9 of the final rule.

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TPMs can only be selected from a list contact information of three references. Pipeline requests authorization to of qualified persons (TPM list) that is Applications will be evaluated as they construct, install, and operate certain developed and maintained by the are received, and each applicant will be natural gas pipeline facilities also in Commission. This notice seeks individually notified of the Cameron Parish, Louisiana. The new additional members for the TPM list, Commission’s decision. liquefaction facilities would have a peak which was originally compiled in 2004, Date: Applications are requested by production capacity of 12 million metric 2010, and 2015. Current members of the January 31, 2019. However, the tons of liquefied natural gas (LNG) per TPM list do not need to reapply, but are application period will remain open annum. encouraged to update their indefinitely to maintain a current listing The final EIS assesses the potential qualifications and contact information, of potential applicants. environmental effects of construction if not current. Each qualified panel Address: Applications must be filed and operation of the Calcasieu Pass member will be listed by area(s) and electronically. See the instructions on Project in accordance with the sub-area(s) of technical expertise, for the Commission’s website (https:// requirements of the National example Aquatic Resources—instream www.ferc.gov/docs-filing/efiling.asp). Environmental Policy Act. The FERC flows. The TPM list and qualifications Applications should reference ‘‘Docket staff concludes that approval of the will be available to the public on the No. AD19–4–000, Notice Requesting proposed project, with the mitigation Commission’s website. All individuals Applications for Panel Member List for measures recommended in the EIS, submitting their applications to the Hydropower Licensing Study Dispute would have some adverse Commission for consideration must Resolution’’. environmental impact; however, all of meet the Commission’s qualifications. Other Information: Complete these impacts would be reduced to less- individual contact information must be than-significant levels. Application Contents provided. However, contact information The U.S. Army Corps of Engineers, The applicant should describe in for the applicant and their references U.S. Coast Guard, U.S. Department of detail his/her qualifications in items 1– may be filed as ‘‘privileged’’. See the Energy, U.S. Environmental Protection 4 listed below. instructions on the Commission’s Agency, and U.S. Department of 1. Technical expertise, including website at https://www.ferc.gov/docs- Transportation participated as education and experience in each filing/efiling.asp. cooperating agencies in the preparation resource area and sub-area for which the FOR FURTHER INFORMATION CONTACT: Kim of the EIS. Cooperating agencies have applicant wishes to be considered: jurisdiction by law or special expertise • Nguyen, Federal Energy Regulatory Aquatic Resources Commission, Office of Energy Projects, with respect to resources potentially Æ water quality affected by a proposal and participate in Æ 888 First Street NE, Room 61–01, instream flows the National Environmental Policy Act Æ Washington, DC 20426, (202) 502–6105, fish passage analysis. Although the cooperating Æ macroinvertebrates [email protected]. Æ agencies provided input on the threatened and endangered species Dated: October 22, 2018. conclusions and recommendations • Terrestrial Resources Kimberly D. Bose, Æ presented in the final EIS, the agencies wildlife biology Secretary. Æ botany will present their own conclusions and Æ wetlands ecology [FR Doc. 2018–23602 Filed 10–29–18; 8:45 am] recommendations in their respective Æ threatened and endangered species BILLING CODE 6717–01–P Records of Decision for the project. • Cultural Resources The final EIS addresses the potential • Recreational Resources environmental effects of the Æ recreational flows DEPARTMENT OF ENERGY construction and operation of the • Land use and Aesthetics following project facilities: Æ shoreline management Federal Energy Regulatory • Nine integrated pre-cooled single • Geology & Soils Commission mixed refrigerant (SMR) blocks; • Æ geomorphology [Docket Nos. CP15–550–000; CP15–551– two full-containment aboveground Æ erosion 000; CP15–551–001] LNG storage tanks, each with a usable • Socio-economics capacity of approximately 200,000 cubic • Engineering Venture Global Calcasieu Pass, LLC; meters; Æ civil engineering TransCameron Pipeline, LLC; Notice of • a 1,500-foot by 3,000-foot turning Æ hydraulic engineering Availability of the Final Environmental basin adjacent to the Calcasieu River Æ environmental engineering Impact Statement for the Proposed Ship Channel; 2. Knowledge of the effects of Calcasieu Pass Project • two LNG berthing docks, each construction and operation of designed to handle carriers of 120,000 to hydroelectric projects. The staff of the Federal Energy 210,000 cubic meter cargo capacity; 3. Working knowledge of laws Regulatory Commission (FERC or • a 720 megawatt natural gas-fired relevant to the expertise, such as: The Commission) has prepared a final combined cycle gas turbine electric Fish and Wildlife Coordination Act, the environmental impact statement (EIS) generation facility; Endangered Species Act, the Clean for the Calcasieu Pass Project, proposed • approximately 23.4 miles of 42- Water Act, the Coastal Zone by Venture Global Calcasieu Pass, LLC inch-diameter pipeline to bring feed gas Management Act, the Wild and Scenic (Venture Global Calcasieu Pass) and from interconnections with ANR Rivers Act, the Federal Power Act, or TransCameron Pipeline, LLC Pipeline Company, Texas Eastern other applicable laws. (TransCameron Pipeline) in the above- Transmission, LP, and Bridgeline 4. Ability to promote constructive referenced dockets. Venture Global Holdings, LP to the terminal site; communication about a disputed study. Calcasieu Pass requests authorization to • one meter station; site, construct, and operate a natural gas • three mainline valves; and How To Submit Applications liquefaction and storage facility, and • one pig launcher at the meter Applicants must submit their marine export terminal in Cameron station and one pig receiver at the gas applications along with the names and Parish, Louisiana. TransCameron gate station on the terminal site.

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The Commission staff mailed a copy ACTION: Notice of availability; request available docket materials are available of the Notice of Availability to federal, for comment. either electronically in state, and local government www.regulations.gov or in hard copy at representatives and agencies; elected SUMMARY: The Environmental Protection the Wastewater Program, Environmental officials; environmental and public Agency (EPA) is providing notice of a Protection Agency (EPA), Region 8, interest groups; Native American tribes; proposed program revision to transfer 1595 Wynkoop Street, Denver, Colorado potentially affected landowners and the authority to implement and enforce 80202–1129. The EPA requests that if at other interested individuals and groups; the North Dakota Pollutant Discharge all possible, you contact the individual and libraries in the project area. The Elimination System (NDPDES) program listed in the FOR FURTHER INFORMATION final EIS is only available in electronic from the North Dakota Department of CONTACT section to view the hard copy format. It may be viewed and Health (NDDOH) to the newly of the docket. You may view the hard downloaded from the FERC’s website established North Dakota Department of copy of the docket Monday through (www.ferc.gov), on the Environmental Environmental Quality (NDDEQ). If Friday, 8 a.m. to 4 p.m., excluding Documents page (https://www.ferc.gov/ approved, the NDDEQ will administer federal holidays. the approved NDPDES program industries/gas/enviro/eis.asp). In FOR FURTHER INFORMATION CONTACT: regulating discharges of pollutants into addition, the final EIS may be accessed VelRey Lozano, U.S. Environmental waters of the United States under its by using the eLibrary link on the FERC’s Protection Agency, Region 8, (8WP– jurisdiction as described in the state’s website. Click on the eLibrary link CWW), 1595 Wynkoop Street, Denver, program application. The EPA will (https://www.ferc.gov/docs-filing/ Colorado 80202–1129, 303–312–6128, retain the authority to issue NPDES elibrary.asp), click on General Search, email [email protected]. permits for facilities located in Indian and enter the docket number in the SUPPLEMENTARY INFORMATION: ‘‘Docket Number’’ field, excluding the country and/or discharging to waters in last three digits (i.e. CP15–550 or CP15– Indian country. Background Information 551). Be sure you have selected an DATES: Written comments and/or On April 7, 2017, the Governor of appropriate date range. For assistance, requests for a public hearing must be North Dakota signed a bill into law please contact FERC Online Support at received on or before November 29, mandating the creation of a new North [email protected] or toll free 2018. Dakota Department of Environmental at (866) 208–3676, or for TTY, contact ADDRESSES: Submit your comments, Quality. NDDEQ will be a cabinet-level (202) 502–8659. identified by Docket ID No. EPA–R08– agency that will implement all of the Additional information about the OAR–2018–0389, to the Federal federally authorized or delegated project is available from the Rulemaking Portal: https:// environmental programs currently run Commission’s Office of External Affairs, www.regulations.gov. Follow the online by the Environmental Health Section of at (866) 208–FERC, or on the FERC instructions for submitting comments. NDDOH. The law gives NDDOH until website (www.ferc.gov) using the Once submitted, comments cannot be July 1, 2019, to obtain the necessary eLibrary link. The eLibrary link also edited or removed from program authorizations and approvals provides access to the texts of all formal www.regulations.gov. The EPA may from EPA to allow NDDEQ to documents issued by the Commission, publish any comment received to its implement the State’s delegated and/or such as orders, notices, and public docket. Do not submit authorized environmental programs. rulemakings. electronically any information you A state may revise its NPDES In addition, the Commission offers a consider to be Confidential Business program. 40 CFR 123.62(a). In doing so, free service called eSubscription that Information (CBI) or other information the State must submit a modified allows you to keep track of all formal whose disclosure is restricted by statute. program description, Attorney General’s issuances and submittals in specific Multimedia submissions (audio, video, statement, Memorandum of Agreement dockets. This can reduce the amount of etc.) must be accompanied by a written or other such documentation as EPA time you spend researching proceedings comment. The written comment is determines to be necessary under the by automatically providing you with considered the official comment and circumstances. 40 CFR 123.62(b). States notification of these filings, document should include discussion of all points with approved programs are required to summaries, and direct links to the you wish to make. The EPA will notify EPA whenever they propose to documents. Go to www.ferc.gov/docs- generally not consider comments or transfer all or part of the approved State filing/esubscription.asp. comment contents located outside of the agency to any other State agency and to Dated: October 22, 2018. primary submission (i.e., on the web, identify any new division of Kimberly D. Bose, cloud, or other file sharing system). For responsibilities amongst the agencies Secretary. additional submission methods, the full involved. 40 CFR 123.62(c). [FR Doc. 2018–23603 Filed 10–29–18; 8:45 am] EPA public comment policy, Organizational charts required in the information about CBI or multimedia State’s original authorization package BILLING CODE 6717–01–P submissions, and general guidance on must be revised and resubmitted. Id. making effective comments, please visit The new agency is not authorized to http://www2.epa.gov/dockets/ administer the program until approved ENVIRONMENTAL PROTECTION commenting-epa-dockets. by the Regional Administrator. AGENCY Docket: All documents in the docket On July 30, 2018, the EPA received a are listed in the www.regulations.gov complete program revision package [Docket ID No. EPA–R08–OAR–2018–0389; index. Although listed in the index, from the state of North Dakota. The EPA FRL–9985–60–Region 8] some information is not publicly has determined the program revision North Dakota Pollutant Discharge available, e.g., CBI or other information package contains all the required Elimination System; Transfer whose disclosure is restricted by statute. elements. The full program revision Certain other material, such as package is available for inspection and AGENCY: Environmental Protection copyrighted material, will be publicly copying at the addresses appearing in Agency (EPA). available only in hard copy. Publicly the ADDRESSES section of this notice.

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General Information community and residents within the regarding entities that this action is state of North Dakota (see Table 1). This likely to affect. A. Does this action apply to me? table is not intended to be exhaustive; Entities potentially affected by this rather, it provides a guide for readers action are: The EPA; and the regulated

TABLE 1—ENTITIES POTENTIALLY AFFECTED BY THIS PROPOSED APPROVAL

Category Examples of potentially affected entities

State and Indian Tribal Governments, and Fed- States and Indian tribes that provide certification under section 401 of the CWA; States, Indian eral Agencies. Tribes, and federal agencies that own or operate treatment works outside of Indian country that require an NDPDES permit. Municipalities ...... POTWs required to apply for or seek coverage under an NDPDES individual or general permit and to perform routine monitoring as a condition of an NDPDES permit. Industry ...... Facilities required to apply for or seek coverage under an NDPDES individual or general permit and to perform routine monitoring as a condition of an NDPDES permit. NDPDES Stakeholders ...... Any party that may review and provide comments on NDPDES permits. Residents of the state of North Dakota ...... Any party that may review and provide comments on NDPDES permits.

If you have any questions regarding required to determine whether proposed This notice allows for an additional 30 the applicability of this action to a program revisions are substantial and, if days for public comments. A fuller particular entity, consult the person so, issue public notice and provide an description of the ICR is given below, listed under FOR FURTHER INFORMATION opportunity to comment for a period of including its estimated burden and cost CONTACT. at least 30 days. The EPA considers this to the public. An agency may neither transfer of state authority to be conduct nor sponsor, and a person is B. What action is EPA taking? substantial. not required to respond to, a collection With this action, the EPA is providing Dated: October 24, 2018. of information unless it displays a notice of a proposed program revision to currently valid OMB control number. Darcy O’Connor, the State of North Dakota’s approved DATES: Additional comments may be NPDES program to transfer authority to Assistant Regional Administrator, Office of Water Protection, EPA, Region 8. submitted on or before November 29, administer the NDPDES program from 2018. the NDDOH to the NDDEQ. This action [FR Doc. 2018–23632 Filed 10–29–18; 8:45 am] BILLING CODE 6560–50–P ADDRESSES: Submit your comments, is not changing the current scope of referencing Docket ID Number EPA– North Dakota’s NDPDES program and is HQ–OECA–2014–0061, to: (1) EPA transferring authority to another agency ENVIRONMENTAL PROTECTION online using www.regulations.gov (our to implement the state’s current NPDES AGENCY preferred method), or by email to program as part of the larger effort to [email protected], or by mail to: EPA move all federally authorized or [EPA–HQ–OECA–2014–0061; FRL–9985– Docket Center, Environmental delegated environmental programs from 59–OEI] Protection Agency, Mail Code 28221T, the NDDOH to the NDDEQ. If the 1200 Pennsylvania Ave. NW, proposed program revision is approved, Information Collection Request Washington, DC 20460; and (2) OMB via EPA will retain the authority to issue Submitted to OMB for Review and email to [email protected]. permits for facilities located in Indian Approval; Comment Request; NESHAP Address comments to OMB Desk Officer 1 country and/or discharging to waters for Chemical Recovery Combustion for EPA. in Indian country. Sources at Kraft, Soda, Sulfite, and The EPA’s policy is that all comments Stand-Alone Semichemical Pulp Mill received will be included in the public C. What is EPA’s authority for taking (Renewal) this action? docket without change including any personal information provided, unless This action is taken under the AGENCY: Environmental Protection Agency (EPA). the comment includes profanity, threats, authority of section 402 of the Clean information claimed to be Confidential ACTION: Notice. Water Act as amended, 33 U.S.C. 1342. Business Information (CBI), or other Under 40 CFR 123.62(b)(2), the EPA is SUMMARY: The Environmental Protection information whose disclosure is restricted by statute. 1 EPA’s approval of North Dakota’s request to Agency (EPA) has submitted an transfer its NPDES authority from the North Dakota information collection request (ICR), FOR FURTHER INFORMATION CONTACT: Department of Health to the North Dakota NESHAP for Chemical Recovery Patrick Yellin, Monitoring, Assistance, Department of Environmental Quality does not Combustion Sources at Kraft, Soda, and Media Programs Division, Office of extend to Indian country. As defined in 18 U.S.C. Compliance, Mail Code 2227A, Section 1151, Indian country generally includes Sulfite, and Stand-Alone Semichemical lands within the exterior boundaries of the Pulp Mill (EPA ICR Number 1805.10, Environmental Protection Agency, 1200 following Indian reservations located within North OMB Control Number 2060–0377), to Pennsylvania Ave. NW, Washington, DC Dakota: The Fort Berthold Indian Reservation, the the Office of Management and Budget 20460; telephone number: (202) 564– Spirit Lake Reservation, the Standing Rock Sioux 2970; fax number: (202) 564–0050; Reservation, and the Turtle Mountain Reservation; (OMB) for review and approval in any land held in trust by the United States for an accordance with the Paperwork email address: [email protected]. Indian tribe; and any other areas that are ‘‘Indian Reduction Act. This is a request for SUPPLEMENTARY INFORMATION: country’’ within the meaning of 18 U.S.C. Section approval of a new collection. Public Supporting documents, which explain 1151. EPA, or eligible Indian tribes, as appropriate, will retain responsibilities under the Clean Water comments were previously requested in detail the information that the EPA Act NPDES program for wastewater discharges in via the Federal Register on June 29, will be collecting, are available in the Indian country. 2017 during a 60-day comment period. public docket for this ICR. The docket

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can be viewed online at Changes in the Estimates: There is collections, and again invites comment www.regulations.gov or in person at the decrease in the total estimated on these renewals. EPA Docket Center, WJC West, Room respondent burden compared with the DATES: Comments must be submitted on 3334, 1301 Constitution Ave. NW, ICR currently approved by OMB. This or before November 29, 2018. Washington, DC. The telephone number ICR includes a more accurate estimate of ADDRESSES: Interested parties are for the Docket Center is 202–566–1744. the number of new respondents based invited to submit written comments to For additional information about the on EPA’s recent consultations with the FDIC by any of the following EPA’s public docket, visit: http:// industry trade groups, which indicated methods: www.epa.gov/dockets. that one new facility will start up in the • https://www.FDIC.gov/regulations/ Abstract: The National Emission third year of this information collection, laws/federal. Standards for Hazardous Air Pollutants in addition to the one new respondent • Email: [email protected]. Include (NESHAP) for Chemical Recovery per year that is an existing facility the name and number of the collection Combustion Sources at Kraft, Soda, constructing new process units. This in the subject line of the message. Sulfite, and Stand-Alone Semichemical ICR also updates the burden associated • Mail: Manny Cabeza (202–898– Pulp Mills apply to new and existing with the October 11, 2017 RTR 3767), Counsel, MB–3007, Federal chemical recovery combustion sources amendments, including removing first- Deposit Insurance Corporation, 550 17th at kraft, soda, sulfite, and stand-alone year costs associated with the Street NW, Washington, DC 20429. semichemical pulp mills, for which the amendments, and accounting for the • Hand Delivery: Comments may be chemical recovery combustion sources remaining one-time burden for facilities hand-delivered to the guard station at emit greater than or equal to 10 tons per that applies through October 2020. the rear of the 17th Street Building year (tpy) of any one hazardous air Courtney Kerwin, (located on F Street), on business days pollutant (HAP) or greater than or equal between 7 a.m. and 5 p.m. to 25 tpy of any combination of HAPs. Director, Regulatory Support Division. All comments should refer to the In general, all NESHAP standards [FR Doc. 2018–23648 Filed 10–29–18; 8:45 am] relevant OMB control number. A copy require initial notifications, BILLING CODE 6560–50–P of the comments may also be submitted performance tests, and periodic reports to the OMB desk officer for the FDIC: by the owners/operators of the affected Office of Information and Regulatory facilities. They are also required to FEDERAL DEPOSIT INSURANCE Affairs, Office of Management and maintain records of any failures to meet CORPORATION Budget, New Executive Office Building, applicable standards, or any period Washington, DC 20503. during which the monitoring system is inoperative. These notifications, reports, [OMB No. 3064–0121; 3064–0135] FOR FURTHER INFORMATION CONTACT: Manny Cabeza, Counsel, 202–898–3767, and records are essential in determining Agency Information Collection compliance, and are required of all [email protected], MB–3007, Federal Activities: Submission for OMB Deposit Insurance Corporation, 550 17th affected facilities subject to 40 CFR part Review; Comment Request 63, subpart MM. Street NW, Washington, DC 20429. Form Numbers: None. AGENCY: Federal Deposit Insurance SUPPLEMENTARY INFORMATION: On August Respondents/affected entities: Corporation (FDIC). 20, 2018, the FDIC requested comment Chemical recovery combustion sources ACTION: Notice and request for comment. for 60 days on a proposal to renew the at kraft, soda, sulfite, and stand-alone information collections described semichemical pulp mills. SUMMARY: The FDIC, as part of its below. No comments were received. The Respondent’s obligation to respond: obligations under the Paperwork FDIC hereby gives notice of its plan to Mandatory (40 CFR part 63, subpart Reduction Act of 1995 (PRA), invites the submit to OMB a request to approve the MM). general public and other Federal renewal of these collections, and again Estimated number of respondents: agencies to take this opportunity to invites comment on these renewals. 107 (total). comment on the renewal of the existing Proposal to renew the following Frequency of response: Initially, information collections described below currently approved collections of occasionally, and semiannually. (3064–0121 and 3064–0135). On August information: Total estimated burden: 122,000 20, 2018, the FDIC requested comment 1. Title: Certification of Compliance hours (per year). Burden is defined at 5 for 60 days on a proposal to renew the with Mandatory Bars to Employment. CFR 1320.3(b). information collections described OMB Number: 3064–00121. Total estimated cost: $14,700,000 (per below. No comments were received. The Form Number: 2120/16. year), which includes $831,000 in FDIC hereby gives notice of its plan to Affected Public: Individuals seeking annualized capital/startup and/or submit to OMB a request to approve the employment from the FDIC. operation & maintenance costs. renewal of these information Burden Estimate:

SUMMARY OF ANNUAL BURDEN

Estimated Total annual Type of burden number of Estimated time per Frequency of estimated respondents response response burden hours

Form 2120/16 ...... Reporting ...... 500 10 minutes ...... On Occasion ...... 83

General Description of Collection: annual burden is due to a decrease in information collection arises from the There has been no change in the method estimated number of new hires from an reporting requirements contained in 12 or substance of this information annual average of 600 in 2015 to an CFR part 336, subpart B of the FDIC collection. The change in estimates annual average of 500 currently. This Rules and Regulations entitled

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‘‘Minimum Standards of Fitness for Affected Public: Individuals and The number of PECs completed each Employment with the Federal Deposit entities wishing to purchase year has been declining since 2009. If Insurance Corporation’’. This rule receivership assets from the FDIC. this trend were to continue, the number implements Section 19 of the Resolution Burden Estimate: There has been no of respondents would be expected to Trust Corporation Completion Act change in the method or substance of continue to decrease from 369 over the (‘‘Completion Act’’), Public Law 103– next three years, which would imply this information collection. The Subject 204, by (among other things) prescribing that the estimated number of Matter Experts (SMEs) from the FDIC’s a certification, with attachments in respondents should be lower for this some cases, relating to job applicants’ Division of Resolutions and collection compared to the one in 2015. fitness and integrity. More specifically, Receiverships have estimated that this The SMEs have acknowledged that 600 the statute provides that the FDIC shall information collection will affect 600 respondents may be a conservative issue regulations implementing respondents annually for the next three estimate, but also believe that it is provisions that prohibit any person from years. This estimate is unchanged from reasonable. This rationale stems from becoming employed by FDIC, who has 2015. The SMEs reached this estimate the fact that the current rate of bank been convicted of any felony; has been by calculating the average number of failures is very low. The SMEs also removed from, or prohibited from Purchaser Eligibility Certifications point out that the PECs are collected participating in the affairs of, any (PECs) completed in the past three years from prospective purchasers and not insured depository institution pursuant and rounding up. just the winning bidders. As a result, the to any final enforcement action by any annual number of PECs could increase appropriate federal banking agency; has Number of if there is an increase in the demand for Year 1 demonstrated a pattern or practice of PECs the assets the FDIC sells even if the defalcation regarding obligations to number of assets for sale decreases in 2015 ...... 952 insured depository institutions; or has line with the current trend of 2016 ...... 468 caused a substantial loss to federal diminishing bank failures. 2017 ...... 369 deposit insurance funds. This collection The estimated hourly burden for this of information implements these Total ...... 1,789 information collection is 30 minutes per mandatory bars to employment through PEC form. The SMEs have arrived at this a certification, signed by job applicants Three-Year Average ...... 596.33 estimate through their personal prior to an offer of employment using observations of individuals completing 1 SMEs within the FDIC’s Division of Reso- form 2120/16. lutions and Receiverships (DRR) compiled this these forms at open-outcry auction 2. Title: Purchaser Eligibility information by the contacting the managers events. The table below contains Certification. that handle each asset sales category (struc- estimates for the total estimated OMB Number: 3064–0135. tured transactions, cash loan sales, other real reporting burden for this information Form Number: 7300–06. estate sales, and securities sales). collection.

SUMMARY OF ANNUAL BURDEN

Total Estimated Estimated Estimated time estimated Type of burden number of frequency of per response annual respondents responses (hrs) burden (hrs)

Purchaser Eligibility Certification ...... Reporting ...... 600 1 0.50 300.00

Request for Comment Federal Deposit Insurance Corporation. banks and nonbanking companies Robert E. Feldman, owned by the bank holding company, Comments are invited on: (a) Whether Executive Secretary. including the companies listed below. the collection of information is [FR Doc. 2018–23597 Filed 10–29–18; 8:45 am] The applications listed below, as well necessary for the proper performance of BILLING CODE 6714–01–P as other related filings required by the the FDIC’s functions, including whether Board, are available for immediate the information has practical utility; (b) inspection at the Federal Reserve Bank the accuracy of the estimates of the indicated. The applications will also be burden of the information collection, FEDERAL RESERVE SYSTEM available for inspection at the offices of including the validity of the the Board of Governors. Interested Formations of, Acquisitions by, and methodology and assumptions used; (c) persons may express their views in Mergers of Bank Holding Companies ways to enhance the quality, utility, and writing on the standards enumerated in clarity of the information to be The companies listed in this notice the BHC Act (12 U.S.C. 1842(c)). If the collected; and (d) ways to minimize the have applied to the Board for approval, proposal also involves the acquisition of burden of the collection of information pursuant to the Bank Holding Company a nonbanking company, the review also on respondents, including through the Act of 1956 (12 U.S.C. 1841 et seq.) includes whether the acquisition of the use of automated collection techniques (BHC Act), Regulation Y (12 CFR part nonbanking company complies with the or other forms of information 225), and all other applicable statutes standards in section 4 of the BHC Act technology. All comments will become and regulations to become a bank (12 U.S.C. 1843). Unless otherwise a matter of public record. holding company and/or to acquire the noted, nonbanking activities will be assets or the ownership of, control of, or conducted throughout the United States. the power to vote shares of a bank or Unless otherwise noted, comments bank holding company and all of the regarding each of these applications

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must be received at the Reserve Bank nonbanking company complies with the 5 U.S.C. 4314(c)(4) requires the indicated or the offices of the Board of standards in section 10(c)(4)(B) of the appointment of board members to be Governors not later than November 27, HOLA (12 U.S.C. 1467a(c)(4)(B)). Unless published in the Federal Register. The 2018. otherwise noted, nonbanking activities following persons comprise a standing A. Federal Reserve Bank of New York will be conducted throughout the roster to serve as members of the SES (Ivan Hurwitz, Vice President) 33 United States. PRB for the Centers for Medicare & Liberty Street, New York, New York Unless otherwise noted, comments Medicaid Services: 10045–0001. Comments can also be sent regarding each of these applications Elisabeth Handley, Director, Office of electronically to must be received at the Reserve Bank Human Capital (serves as the Chair) [email protected]: indicated or the offices of the Board of Demetrious Kouzoukas, Principal 1. The Adirondack Trust Company Governors not later than November 27, Deputy Administrator for Medicare Employee Stock Ownership Trust, 2018. Karen Jackson, Deputy Chief Operating Saratoga Springs, New York; to acquire A. Federal Reserve Bank of Officer fifty additional shares of 473 Broadway Philadelphia (William Spaniel, Senior Jeffrey Wu, Deputy Director for Holding Corporation and two thousand Vice President) 100 North 6th Street, Operations, Center for Consumer additional shares of The Adirondack Philadelphia, Pennsylvania 19105– Information and Insurance Oversight Trust Company, both of Saratoga 1521. Comments can also be sent Jean Moody-Williams, Deputy Center Springs, New York. electronically to Comments. Director, Center for Clinical Standards B. Federal Reserve Bank of Kansas [email protected]: and Quality City (Dennis Denney, Assistant Vice 1. WSFS Financial Corporation, Nancy O’Connor, Philadelphia Regional President) 1 Memorial Drive, Kansas Wilmington, Delaware; to merge with Administrator City, Missouri 64198–0001: Beneficial Bancorp, Inc., Philadelphia, 1. Foote Financial Services, LLC, Pennsylvania, and therefore indirectly Dated: October 16, 2018. Hoxie, Kansas; to become a bank acquire shares of Beneficial Bank, Elisabeth Handley, holding company by acquiring voting Philadelphia, Pennsylvania. WSFS Director, Office of Human Capital. shares of Peoples State Bank, Financial Corporation has applied to [FR Doc. 2018–23814 Filed 10–29–18; 8:45 am] Manhattan, Kansas. become a savings and loan holding BILLING CODE 4120–01–P Board of Governors of the Federal Reserve company with respect to Beneficial System, October 25, 2018. Bank’s conversion to a stock federal Yao-Chin Chao, savings association. DEPARTMENT OF HEALTH AND Assistant Secretary of the Board. Board of Governors of the Federal Reserve HUMAN SERVICES System, October 25, 2018. [FR Doc. 2018–23682 Filed 10–29–18; 8:45 am] Centers for Medicare & Medicaid Yao-Chin Chao, BILLING CODE P Services Assistant Secretary of the Board. [FR Doc. 2018–23683 Filed 10–29–18; 8:45 am] [CMS–3369–PN] FEDERAL RESERVE SYSTEM BILLING CODE P Formations of, Acquisitions by, and Medicare and Medicaid Programs: Mergers of Savings and Loan Holding Application From the American Companies DEPARTMENT OF HEALTH AND Association for Accreditation of HUMAN SERVICES Ambulatory Surgery Facilities, Inc. The companies listed in this notice (AAAASF) for Continued CMS- have applied to the Board for approval, Centers for Medicare & Medicaid Approval of Its Outpatient Physical pursuant to the Home Owners’ Loan Act Services Therapy and Speech Language (12 U.S.C. 1461 et seq.) (HOLA), Performance Review Board Pathology Services Accreditation Regulation LL (12 CFR part 238), and Program Regulation MM (12 CFR part 239), and Membership all other applicable statutes and AGENCY: Centers for Medicare & AGENCY: Centers for Medicare and regulations to become a savings and Medicaid Services, HHS. Medicaid Services (CMS), HHS. loan holding company and/or to acquire ACTION: Notice of Performance Review ACTION: Notice with request for the assets or the ownership of, control Board Membership. comment. of, or the power to vote shares of a savings association and nonbanking FOR FURTHER INFORMATION CONTACT: SUMMARY: This proposed notice companies owned by the savings and Kathy Vaughn, 410–786–1050 or acknowledges the receipt of an loan holding company, including the [email protected]. application from the American companies listed below. SUMMARY: 5 U.S.C. 4314(c)(1) through Association for Accreditation of The applications listed below, as well (5) requires each agency to establish, in Ambulatory Surgery Facilities, Inc. as other related filings required by the accordance with regulations prescribed (AAAASF) for continued recognition as Board, are available for immediate by the Office of Personnel Management, a national accrediting organization (AO) inspection at the Federal Reserve Bank one or more Senior Executive Service for clinics, rehabilitation agencies, or indicated. The application also will be (SES) Performance Review Boards. public health agencies that furnish available for inspection at the offices of The PRB shall review and evaluate outpatient physical therapy and speech the Board of Governors. Interested the initial summary rating of a senior language pathology services that wish to persons may express their views in executive’s performance, the executive’s participate in the Medicare or Medicaid writing on the standards enumerated in response, and the higher-level official’s programs. the HOLA (12 U.S.C. 1467a(e)). If the comments on the initial summary DATES: To be assured consideration, proposal also involves the acquisition of rating. In addition, the PRB will review comments must be received at one of a nonbanking company, the review also and recommend executive performance the addresses provided below, no later includes whether the acquisition of the bonuses and pay increases. than 5 p.m. on November 29, 2018.

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ADDRESSES: In commenting, please refer relating to the survey and certification ability to provide CMS with the to file code CMS–3369–PN. Because of of facilities are at 42 CFR part 488. The necessary data for validation. staff and resource limitations, we cannot regulations at 42 CFR part 485 subpart Section 1865(a)(3)(A) of the Act accept comments by facsimile (FAX) H specify the conditions that a clinic, further requires that we publish, within transmission. rehabilitation agency or public health 60 days of receipt of an organization’s Comments, including mass comment agency (‘‘OPT providers’’) must meet in complete application, a notice submissions, must be submitted in one order to participate in the Medicare identifying the national accrediting of the following three ways (please program, the scope of covered services, body making the request, describing the choose only one of the ways listed): and the conditions for Medicare nature of the request, and providing at 1. Electronically. You may submit payment for OPT providers. least a 30-day public comment period. electronic comments on this regulation Generally, to enter into an agreement, We have 210 days from the receipt of a to http://www.regulations.gov. Follow an OPT provider must first be certified complete application to publish notice the ‘‘Submit a comment’’ instructions. by a State survey agency as complying of approval or denial of the application. 2. By regular mail. You may mail with the conditions of participation set The purpose of this proposed notice written comments to the following forth in part 485, subpart H of our is to inform the public of AAAASF’s address ONLY: Centers for Medicare & Medicare regulations. Thereafter, the request for continued CMS approval of Medicaid Services, Department of OPT provider is subject to regular its OPT provider accreditation program. Health and Human Services, Attention: surveys by a State survey agency to This proposed notice also solicits public CMS–3369–PN, P.O. Box 8010, determine whether it continues to meet comment on whether AAAASF’s Baltimore, MD 21244–8010. these requirements. requirements meet or exceed the Please allow sufficient time for mailed Section 1865(a)(1) of the Act provides Medicare conditions of participation comments to be received before the that, if a provider entity demonstrates (CoPs) for OPT providers. close of the comment period. through accreditation by a Centers for III. Evaluation of an AO’s Accreditation 3. By express or overnight mail. You Medicare & Medicaid Services (CMS) Program may send written comments to the approved national accrediting AAAASF submitted all the necessary following address ONLY: Centers for organization (AO) that all applicable materials to enable us to make a Medicare & Medicaid Services, Medicare conditions are met or determination concerning its request for Department of Health and Human exceeded, we may deem those provider continued CMS-approval of its OPT Services, Attention: CMS–3369–PN, entities as having met the requirements. provider accreditation program. This Mail Stop C4–26–05, 7500 Security Accreditation by an AO is voluntary and application was determined to be Boulevard, Baltimore, MD 21244–1850. is not required for Medicare complete on September 6, 2018. Under For information on viewing public participation. Section 1865(a)(2) of the Act and our comments, see the beginning of the If an AO is recognized by the regulations at § 488.5, our review and SUPPLEMENTARY INFORMATION section. Secretary of the Department of Health evaluation of AAAASF will be FOR FURTHER INFORMATION CONTACT: Erin and Human Services as having conducted in accordance with, but not McCoy, (410) 786–2337, Monda Shaver, standards for accreditation that meet or necessarily limited to, the following (410) 786–3410, or Renee Henry, (410) exceed Medicare requirements, any factors: 786–7828. provider entity accredited by the • The equivalency of AAAASF’s SUPPLEMENTARY INFORMATION: national accrediting body’s approved standards for OPT providers as Inspection of Public Comments: All program may be deemed to meet the compared with Medicare’s CoPs for OPT comments received before the close of Medicare conditions. An AO applying providers. the comment period are available for for approval of its accreditation program • AAAASF’s survey process to viewing by the public, including any under part 488, subpart A, must provide determine the following: personally identifiable or confidential CMS with reasonable assurance that the ++ The composition of the survey business information that is included in AO requires the accredited provider team, surveyor qualifications, and the a comment. We post all comments entities to meet requirements that are at ability of the organization to provide received before the close of the least as stringent as the Medicare continuing surveyor training. comment period on the following conditions. Our regulations concerning ++ The comparability of AAAASF’s website as soon as possible after they the approval of AOs are set forth at processes to those of State agencies, have been received: http:// § 488.5. including survey frequency, and the www.regulations.gov. Follow the search AAAASF’s current term of approval ability to investigate and respond instructions on that website to view for its OPT provider accreditation appropriately to complaints against public comments. program expires April 4, 2019. accredited facilities. ++ AAAASF’s processes and II. Approval of Deeming Organizations I. Background procedures for monitoring an OPT Under section 1861(p) of the Medicare Section 1865(a)(2) of the Act and our provider found out of compliance with statute, eligible beneficiaries may regulations at § 488.5 require that our AAAASF’s program requirements. receive outpatient physical therapy and findings concerning review and These monitoring procedures are used speech language pathology (OPT) approval of an AO’s requirements only when AAAASF identifies services from a provider of services, a consider, among other factors, the noncompliance. If noncompliance is clinic, rehabilitation agency, a public applying AO’s requirements for identified through validation reviews or health agency, or others, provided accreditation; survey procedures; complaint surveys, the State survey certain requirements are met. Section resources for conducting required agency monitors corrections as specified 1832(a)(2)(C) of the Social Security Act surveys; capacity to furnish information at § 488.9(c)(1). (the Act) permits payment for OPT for use in enforcement activities; ++ AAAASF’s capacity to report services. Regulations concerning monitoring procedures for provider deficiencies to the surveyed facilities provider agreements are at 42 CFR part entities found not in compliance with and respond to the facility’s plan of 489 and those pertaining to activities the conditions or requirements; and correction in a timely manner.

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++ AAAASF’s capacity to provide DEPARTMENT OF HEALTH AND comment does not include any CMS with electronic data and reports HUMAN SERVICES confidential information that you or a necessary for effective validation and third party may not wish to be posted, assessment of the organization’s survey Food and Drug Administration such as medical information, your or process. [Docket No. FDA–2018–N–3689] anyone else’s Social Security number, or confidential business information, such ++ The adequacy of AAAASF’s staff 21st Century Cures: Announcing the as a manufacturing process. Please note and other resources, and its financial Establishment of a Surrogate Endpoint that if you include your name, contact viability. Table; Establishment of a Public information, or other information that ++ AAAASF’s capacity to adequately Docket; Request for Comments identifies you in the body of your fund required surveys. comments, that information will be AGENCY: Food and Drug Administration, ++ AAAASF’s policies with respect posted on https://www.regulations.gov. HHS. • If you want to submit a comment to whether surveys are announced or ACTION: Notice; establishment of docket; with confidential information that you unannounced, to assure that surveys are request for comments. do not wish to be made available to the unannounced. public, submit the comment as a SUMMARY: The Food and Drug ++ AAAASF’s agreement to provide written/paper submission and in the Administration (FDA or Agency) is CMS with a copy of the most current manner detailed (see ‘‘Written/Paper announcing the establishment of a accreditation survey together with any Submissions’’ and ‘‘Instructions’’). public docket to receive suggestions and other information related to the survey comments from interested parties Written/Paper Submissions as CMS may require (including (including academic institutions, corrective action plans). Submit written/paper submissions as regulated industry, and patient groups) follows: IV. Collection of Information on the Agency’s publication of the • Mail/Hand delivery/Courier (for Requirements surrogate endpoint table (SE table). FDA written/paper submissions): Dockets has developed a web page, available at Management Staff (HFA–305), Food and This document does not impose https://www.fda.gov/Drugs/ Drug Administration, 5630 Fishers information collection requirements, DevelopmentApprovalProcess/ Lane, Rm. 1061, Rockville, MD 20852. that is, reporting, recordkeeping or DevelopmentResources/ucm613636.htm • For written/paper comments third-party disclosure requirements. that displays the SE table, describes the submitted to the Dockets Management Consequently, there is no need for purpose of the table, and provides Staff, FDA will post your comment, as review by the Office of Management and additional background information. well as any attachments, except for Budget under the authority of the Comments received on the SE table will information submitted, marked and Paperwork Reduction Act of 1995 (44 help FDA determine its utility and may identified, as confidential, if submitted U.S.C. 3501 et seq.). assist FDA in developing future as detailed in ‘‘Instructions.’’ iterations of the SE table and identifying Instructions: All submissions received V. Response to Public Comments best methods for conveying information must include the Docket No. FDA– about SEs on the FDA’s website. 2018–N–3689 for ‘‘21st Century Cures: Because of the large number of public DATES: Submit either electronic or Announcing the Establishment of a comments we normally receive on written comments on this notice by Surrogate Endpoint Table.’’ Received Federal Register documents, we are not December 31, 2018. comments, those filed in a timely able to acknowledge or respond to them ADDRESSES: You may submit comments manner (see ADDRESSES), will be placed individually. We will consider all as follows. Please note that late, in the docket and, except for those comments we receive by the date and untimely filed comments will not be submitted as ‘‘Confidential time specified in the DATES section of considered. Electronic comments must Submissions,’’ publicly viewable at this preamble, and, when we proceed be submitted on or before December 31, https://www.regulations.gov or at the with a subsequent document, we will 2018. The https://www.regulations.gov Dockets Management Staff between 9 respond to the comments in the electronic filing system will accept a.m. and 4 p.m., Monday through preamble to that document. comments until 11:59 p.m. Eastern Time Friday. • Upon completion of our evaluation, at the end of December 31, 2018. Confidential Submissions—To including evaluation of comments Comments received by mail/hand submit a comment with confidential received as a result of this proposed delivery/courier (for written/paper information that you do not wish to be made publicly available, submit your notice, we will publish a final notice in submissions) will be considered timely comments only as a written/paper the Federal Register announcing the if they are postmarked or the delivery submission. You should submit two result of our evaluation. service acceptance receipt is on or before that date. copies total. One copy will include the Dated: October 19, 2018. information you claim to be confidential Seema Verma, Electronic Submissions with a heading or cover note that states Administrator, Centers for Medicare & Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS Medicaid Services. following way: CONFIDENTIAL INFORMATION.’’ The • [FR Doc. 2018–23611 Filed 10–29–18; 8:45 am] Federal eRulemaking Portal: Agency will review this copy, including https://www.regulations.gov. Follow the the claimed confidential information, in BILLING CODE 4120–01–P instructions for submitting comments. its consideration of comments. The Comments submitted electronically, second copy, which will have the including attachments, to https:// claimed confidential information www.regulations.gov will be posted to redacted/blacked out, will be available the docket unchanged. Because your for public viewing and posted on comment will be made public, you are https://www.regulations.gov. Submit solely responsible for ensuring that your both copies to the Dockets Management

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Staff. If you do not wish your name and physical sign, or other measure, that DEPARTMENT OF HEALTH AND contact information to be made publicly does not directly measure clinical HUMAN SERVICES available, you can provide this benefit but (1) is known to predict information on the cover sheet and not clinical benefit and can potentially be Food and Drug Administration in the body of your comments and you used to support traditional approval of [Docket No. FDA–2018–N–3809] must identify this information as a drug or biological product or (2) is ‘‘confidential.’’ Any information marked reasonably likely to predict clinical Sesame as an Allergen in Foods as ‘‘confidential’’ will not be disclosed benefit and could be used to support AGENCY: Food and Drug Administration, except in accordance with 21 CFR 10.20 accelerated approval in accordance with and other applicable disclosure law. For HHS. section 506(c) of the FD&C Act (21 ACTION: Notice; request for comments. more information about FDA’s posting U.S.C. 356(c)). of comments to public dockets, see 80 SUMMARY: The Food and Drug FR 56469, September 18, 2015, or access This SE table includes SEs that sponsors have used as primary efficacy Administration (FDA or we) invites data the information at: https://www.gpo.gov/ and other information on the prevalence clinical trial endpoints for approval of fdsys/pkg/FR-2015-09-18/pdf/2015- and severity of sesame allergies in the new drug applications (NDAs) or 23389.pdf. United States and the prevalence of Docket: For access to the docket to biologics license applications (BLAs). sesame-containing foods sold in the read background documents or the The table also includes SEs that may be United States that are not required to electronic and written/paper comments appropriate for use as a primary efficacy disclose sesame as an ingredient. We are received, go to https:// clinical trial endpoint for drug or taking this action to inform possible www.regulations.gov and insert the biologic approval, although the SEs regulatory action on sesame to protect docket number, found in brackets in the have not necessarily been used to and promote the public health. heading of this document, into the support an approved NDA or BLA. FDA DATES: Submit either electronic or ‘‘Search’’ box and follow the prompts believes that this table should facilitate written comments on this document by and/or go to the Dockets Management discussions of potential SEs by sponsors December 31, 2018. Staff, 5630 Fishers Lane, Rm. 1061, when developers are designing their ADDRESSES: Rockville, MD 20852. You may submit comments drug development programs. as follows. Electronic comments must FOR FURTHER INFORMATION CONTACT: II. Additional Issues for Consideration be submitted on or before December 31, Christopher Leptak, Center for Drug 2018. The https://www.regulations.gov Evaluation and Research, Food and To help FDA determine the utility of electronic filing system will accept Drug Administration, 10903 New the SE table, develop future iterations of comments until 11:59 p.m. Eastern Time Hampshire Ave., Bldg. 22, Rm. 6461, the SE table, and identify best methods at the end of December 31, 2018. Silver Spring, MD 20993–0002, 301– for conveying this information on FDA’s Comments received by mail/hand 796–0017, Christopher.Leptak@ delivery/courier (for written/paper fda.hhs.gov; or Stephen Ripley, Center website, FDA is soliciting public suggestions and comments on the SE submissions) will be considered timely for Biologics Evaluation and Research, if they are postmarked or the delivery Food and Drug Administration, 10903 table listed on the following web page: https://www.fda.gov/Drugs/ service acceptance receipt is on or New Hampshire Ave., Bldg. 71, Rm. before that date. 7301, Silver Spring, MD 20993–0002, DevelopmentApprovalProcess/ 240–402–7911. DevelopmentResources/ucm60 Electronic Submissions SUPPLEMENTARY INFORMATION: 6684.htm. Submit electronic comments in the Specifically, FDA welcomes following way: I. Background comments concerning: (1) The utility of • Federal eRulemaking Portal: Section 3011 of the 21st Century the SE table; (2) suggestions on SEs that https://www.regulations.gov. Follow the Cures Act established section 507 of the may not be reflected on the current SE instructions for submitting comments. Federal Food, Drug, and Cosmetic Act table but that have been used for drug Comments submitted electronically, (FD&C Act) (21 U.S.C. 357), which or biologic approvals; (3) the best including attachments, to https:// mandates that FDA publish a list of approach for developing future www.regulations.gov will be posted to surrogate endpoints used as a basis to iterations of the table, and (4) SE table the docket unchanged. Because your approve or license a drug or biological questions you would like FDA to comment will be made public, you are product under both accelerated and address in future communications. As solely responsible for ensuring that your traditional approval provisions. The SE required by section 507(c)(1) of the comment does not include any table fulfills this legislative requirement confidential information that you or a FD&C Act, FDA will update this table and is intended to provide valuable third party may not wish to be posted, on the website every 6 months. The information for drug developers on such as medical information, your or Agency will consider comments endpoints that may be considered and anyone else’s Social Security number, or discussed with FDA for individual submitted to the docket as it revises the confidential business information, such development programs. FDA refers the SE table. as a manufacturing process. Please note public to the following web page for Dated: October 25, 2018. that if you include your name, contact additional background information as Leslie Kux, information, or other information that well as the SE table: https:// Associate Commissioner for Policy. identifies you in the body of your www.fda.gov/Drugs/Development comments, that information will be [FR Doc. 2018–23641 Filed 10–29–18; 8:45 am] ApprovalProcess/Development posted on https://www.regulations.gov. Resources/ucm606684.htm. BILLING CODE 4164–01–P • If you want to submit a comment Section 507(e)(9) of the FD&C Act with confidential information that you defines the term ‘‘surrogate endpoint’’ to do not wish to be made available to the mean a marker, e.g., a laboratory public, submit the comment as a measurement, radiographic image, written/paper submission and in the

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manner detailed (see ‘‘Written/Paper electronic and written/paper comments allergic reactions. We issued guidance Submissions’’ and ‘‘Instructions’’). received, go to https:// in 2006 to help the public understand www.regulations.gov and insert the our implementation of the amendments, Written/Paper Submissions docket number, found in brackets in the including what foods and manufacturers Submit written/paper submissions as heading of this document, into the are subject to the amendments and follows: ‘‘Search’’ box and follow the prompts labeling requirements (Ref. 2). We • Mail/Hand delivery/Courier (for and/or go to the Dockets Management issued another guidance in 2014 to written/paper submissions): Dockets Staff, 5630 Fishers Lane, Rm. 1061, clarify the information we need when Management Staff (HFA–305), Food and Rockville, MD 20852. considering whether to exempt certain Drug Administration, 5630 Fishers FOR FURTHER INFORMATION CONTACT: ingredients derived from major food Lane, Rm. 1061, Rockville, MD 20852. allergens from the allergen labeling • Carol D’Lima, Office of Nutrition and For written/paper comments requirements (Ref. 3). These statutory submitted to the Dockets Management Food Labeling, Center for Food Safety and Applied Nutrition, Food and Drug requirements with respect to a label or Staff, FDA will post your comment, as labeling for major food allergens do not well as any attachments, except for Administration, 5001 Campus Dr., College Park, MD 20740, 240–402–2033. alter the authority of the Secretary of information submitted, marked and Health and Human Services under the SUPPLEMENTARY INFORMATION: identified, as confidential, if submitted FD&C Act to require a label or labeling as detailed in ‘‘Instructions.’’ I. Background for other food allergens (21 U.S.C. 343 Instructions: All submissions received note). Food allergies occur when the body’s must include the Docket No. FDA– A common or usual name must immune system reacts to certain food 2018–N–3809 for ‘‘Sesame as an accurately identify or describe, in as Allergen in Foods.’’ proteins (Ref. 1). Allergic reactions to simple and direct terms as possible, the Received comments, those filed in a food due to immunoglobulin E (IgE) basic nature of the food or its timely manner (see ADDRESSES), will be antibodies cause the body to release characterizing properties or ingredients placed in the docket and, except for inflammatory chemicals and can be and can either be the name established those submitted as ‘‘Confidential particularly severe, leading to symptoms by common use or the name required by Submissions,’’ publicly viewable at such as hives, facial swelling, vomiting, a regulation (21 CFR 102.5). In addition https://www.regulations.gov or at the wheezing, shock, and even death. to the specific requirement for allergen Dockets Management Staff between 9 Because there is no cure for food labeling, any food is misbranded unless a.m. and 4 p.m., Monday through allergies, allergic consumers must use its label uses: (1) The common or usual Friday. avoidance to prevent allergic reactions. • name of the food, if it has one, and (2) Confidential Submissions—To Successful avoidance requires, among the common or usual name of each submit a comment with confidential other things, that allergic consumers ingredient, if the food is made from two information that you do not wish to be and their caregivers can read and or more ingredients (section 403(i) of made publicly available, submit your understand the relevant information on the FD&C Act). Thus, the FD&C Act comments only as a written/paper packaged food labels and can identify includes other authorities that assist submission. You should submit two food allergens in other settings, such as consumers with a food allergy or other copies total. One copy will include the at retail or food service establishments. reason for avoiding an ingredient. For information you claim to be confidential The Federal Food, Drug, and Cosmetic example, the label of a food made with with a heading or cover note that states Act (FD&C Act) requires that a food sugar must declare this ingredient by its ‘‘THIS DOCUMENT CONTAINS (other than a raw agricultural common or usual name—‘‘sugar’’— CONFIDENTIAL INFORMATION.’’ We commodity) that bears or contains a rather than the chemical name will review this copy, including the ‘‘major food allergen’’ declare the ‘‘sucrose’’ (see section 403(i) of the claimed confidential information, in our allergen using its ‘‘common or usual FD&C Act (21 U.S.C. 343(i))). consideration of comments. The second name.’’ A food is misbranded if it In addition, section 403(x) of the copy, which will have the claimed contains a major food allergen and fails FD&C Act gives us the authority to issue confidential information redacted/ to declare that major food allergen on its regulations requiring the disclosure of blacked out, will be available for public label using the major food allergen’s spices, flavorings, colorings, and viewing and posted on https:// common or usual name (section 403(w) incidental additives that are, or contain, www.regulations.gov. Submit both of the FD&C Act). The FD&C Act defines allergens other than the eight major food copies to the Dockets Management Staff. a ‘‘major food allergen,’’ in part, as any allergens. We relied on this authority, in If you do not wish your name and of the following: part, to require the labeling of carmine contact information to be made publicly • Milk, and cochineal in foods (see 74 FR 207). available, you can provide this • Eggs, In 2014, the Center for Science in the information on the cover sheet and not • Fish (e.g., bass, flounder, or cod), Public Interest, several medical in the body of your comments and you • Crustacean shellfish (e.g., crab, professionals, and two consumer must identify this information as lobster, or shrimp), advocacy groups submitted a citizen ‘‘confidential.’’ Any information marked • Tree nuts (e.g., almonds, pecans, or petition (Ref. 4) requesting, in part, that as ‘‘confidential’’ will not be disclosed walnuts), we issue a rule to require that sesame except in accordance with 21 CFR 10.20 • Wheat, seeds and sesame products be regulated and other applicable disclosure law. For • Peanuts, and in a manner similar to the manner in more information about FDA’s posting • Soybeans. which major food allergens are of comments to public dockets, see 80 See section 201(qq)(1) of the FD&C regulated under the FD&C Act, and FR 56469, September 18, 2015, or access Act (21 U.S.C. 321(qq)(1)). When specifically to require sesame’s the information at: https://www.gpo.gov/ Congress amended the FD&C Act disclosure by the common or usual fdsys/pkg/FR-2015-09-18/pdf/2015- regarding food allergens in 2004, these name ‘‘sesame’’ in food labeling. The 23389.pdf. eight foods and food groups, out of more petition noted, among other things, that Docket: For access to the docket to than 160 identified food allergens, the European Union, Canada, Australia, read background documents or the accounted for 90 percent of serious food and New Zealand require labeling of

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sesame and provided scientific homes, childcare centers, and temporary sesame? We are interested in any costs, information to support the petitioners’ food establishments)? specifically those to manufacturers for argument that sesame is an allergen of 5. In packaged food products, what labeling changes to reflect sesame as an public health concern. The petition also proportion of allergic reactions to ingredient, spice, flavor, color, or requested that we add sesame to our list sesame is due to: incidental additive. of allergens in our Compliance Policy a. Sesame in generically listed spices, 2. What would the costs be to Guide, which includes discussion of flavorings, colorings, or incidental manufacturers to control allergen cross- adulteration due to insufficient controls additives; contact from sesame and what would to prevent potential allergen cross- b. Sesame used as an ingredient and the costs be of educating food managers contact (the unintentional incorporation listed by some other name (e.g., ‘‘tahini’’ at retail or food establishments to of allergens into foods that are not rather than ‘‘sesame’’); or control for sesame as an allergen? intended to include those allergens) c. Cross-contact? (Ref. 5). Since the citizen petition was 3. What steps have manufacturers B. Prevalence and Amounts of posted, more than 750 comments have taken to eliminate or reduce cross- Undeclared Sesame in Foods been submitted to the docket. contact from sesame and/or sesame- containing ingredients? We are interested in learning more 1. What are examples of products or about the prevalence and severity of product categories that contain sesame III. References sesame allergies in the United States, as a spice, flavor, color, or incidental and the prevalence of sesame-containing additive and that do not list ‘‘sesame’’ The following references are on foods sold in the United States that are on the product labeling? display at the Dockets Management Staff not required to disclose sesame as an 2. What amount or concentration of (see ADDRESSES) and are available for ingredient. We will consider the data sesame is in products or product viewing by interested persons between and other information submitted, along categories that contain sesame as a 9 a.m. and 4 p.m., Monday through with previously submitted information, spice, flavor, color, or incidental Friday; they are also available to inform possible steps on sesame as an additive and that do not list ‘‘sesame’’ electronically at https:// allergen in food to protect and promote on the product labeling? Please provide www.regulations.gov. FDA has verified the public health. a unit of measure (e.g., ‘‘5 grams of the website addresses, as of the date this sesame per kilogram of packaged food document publishes in the Federal II. Additional Issues for Consideration; product’’ or ‘‘50 milligrams of sesame Register, but websites are subject to Request for Data and Information protein per serving’’). change over time. We invite comment, particularly 3. What are examples of products or product categories other than ‘‘spices’’ 1. FDA. ‘‘Food Allergies: What You Need to scientific data and other evidence, about Know.’’ March 2017. Available at https:// the following topics: that contain sesame in one of the listed ingredients, but the common or usual www.fda.gov/downloads/Food/ ResourcesForYou/Consumers/UCM22 A. Prevalence of Allergies and Allergic name of that ingredient does not list 0117.pdf. Reactions Due to Sesame in the United ‘‘sesame,’’ specifically, on the product 2. ‘‘Guidance for Industry: Questions and States labeling? Please provide a copy of the Answers Regarding Food Allergens, labeling, if available. 1. What is the prevalence of IgE- Including the Food Allergen Labeling 4. What amount or concentration of mediated sesame food allergies in the and Consumer Protection Act of 2004’’ sesame is in products or product United States? Please provide any (Edition 4). October 2006. Available at studies or data that support your categories that contain sesame in one of https://www.fda.gov/Food/ conclusion, and provide your unit of the listed ingredients, but the common GuidanceRegulation/Guidance measure (e.g., ‘‘1 in 10,000 adults’’). or usual name of that ingredient does DocumentsRegulatoryInformation/ What is the nature of the allergic not list ‘‘sesame,’’ specifically, on the ucm059116.htm. response(s) to sesame in food and what product labeling? Please provide a unit 3. ‘‘Guidance for Industry: Food Allergen are the impacts on consumers? of measure (e.g., ‘‘5 grams of sesame per Labeling Exemption Petitions and kilogram of packaged food product’’ or 2. How does the prevalence of IgE- Notifications.’’ May 2014. Available at ‘‘50 milligrams of sesame protein per https://www.fda.gov/Food/ mediated sesame food allergies in the serving’’). United States compare to the prevalence GuidanceRegulation/Guidance 5. What are examples of food products DocumentsRegulatoryInformation/ of IgE-mediated allergies to the major or product categories in which sesame food allergens? Please provide any ucm395494.htm. has been found in a product because of 4. Docket No. FDA–2014–P–2035, available studies or data that support your cross-contact? conclusion. at https://www.regulations.gov/ 6. What amount or concentration of docket?D=FDA-2014-P-2035. 3. What proportion of allergic sesame has been found in products or 5. ‘‘Compliance Policy Guide Sec. 555.250 reactions in the United States may be product categories that contain sesame Statement of Policy for Labeling and attributed specifically to exposure to because of cross-contact? Please provide Preventing Cross-contact of Common undeclared sesame? Please provide any a unit of measure (e.g., ‘‘5 grams of Food Allergens.’’ August 2000. Available studies or data that support your sesame per kilogram of packaged food at https://www.fda.gov/ucm/groups/ conclusion. product’’ or ‘‘50 milligrams of sesame fdagov-public/@fdagov-afda-ice/ 4. What proportion of allergic protein per serving’’). documents/webcontent/ucm074552.pdf. reactions to undeclared sesame occur in Dated: October 24, 2018. response to sesame found in packaged C. Possible Costs of Any Future food products versus sesame found in Regulatory Action FDA Might Take Leslie Kux, foods served at retail or food service Regarding Sesame Associate Commissioner for Policy. establishments (e.g., restaurants, grocery 1. What would the costs be if we [FR Doc. 2018–23635 Filed 10–29–18; 8:45 am] stores, supermarkets, hospitals, nursing established disclosure requirements for BILLING CODE 4164–01–P

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DEPARTMENT OF HEALTH AND information, or other information that and other applicable disclosure law. For HUMAN SERVICES identifies you in the body of your more information about FDA’s posting comments, that information will be of comments to public dockets, see 80 Food and Drug Administration posted on https://www.regulations.gov. FR 56469, September 18, 2015, or access • [Docket No. FDA–2018–D–3759] If you want to submit a comment the information at: https://www.gpo.gov/ with confidential information that you fdsys/pkg/FR-2015-09-18/pdf/2015- Considerations for the Development of do not wish to be made available to the 23389.pdf. Dried Plasma Products Intended for public, submit the comment as a Docket: For access to the docket to Transfusion; Draft Guidance for written/paper submission and in the read background documents or the Industry; Availability manner detailed (see ‘‘Written/Paper electronic and written/paper comments Submissions’’ and ‘‘Instructions’’). received, go to https:// AGENCY: Food and Drug Administration, Written/Paper Submissions www.regulations.gov and insert the HHS. docket number, found in brackets in the ACTION: Notice of availability. Submit written/paper submissions as heading of this document, into the follows: ‘‘Search’’ box and follow the prompts SUMMARY: The Food and Drug • Mail/Hand delivery/Courier (for Administration (FDA or Agency) is and/or go to the Dockets Management written/paper submissions): Dockets Staff, 5630 Fishers Lane, Rm. 1061, announcing the availability of a draft Management Staff (HFA–305), Food and document entitled ‘‘Considerations for Rockville, MD 20852. Drug Administration, 5630 Fishers You may submit comments on any the Development of Dried Plasma Lane, Rm. 1061, Rockville, MD 20852. guidance at any time (see 21 CFR Products Intended for Transfusion; Draft • For written/paper comments 10.115(g)(5)). Guidance for Industry.’’ This guidance submitted to the Dockets Management Submit written requests for single is intended to assist manufacturers, Staff, FDA will post your comment, as copies of the draft guidance to the Office sponsors, and applicants developing well as any attachments, except for dried plasma products intended for information submitted, marked and of Communication, Outreach and transfusion in order to facilitate the identified, as confidential, if submitted Development, Center for Biologics availability of safe and effective dried as detailed in ‘‘Instructions.’’ Evaluation and Research (CBER), Food plasma products in the United States. Instructions: All submissions received and Drug Administration, 10903 New The draft guidance document provides must include the Docket No. FDA– Hampshire Ave., Bldg. 71, Rm. 3128, considerations for the successful 2018–D–3759 for ‘‘Considerations for Silver Spring, MD 20993–0002. Send development and licensing of dried the Development of Dried Plasma one self-addressed adhesive label to plasma products and for the approval of Intended for Transfusion; Draft assist the office in processing your devices used to manufacture dried Guidance for Industry.’’ Received requests. The draft guidance may also be plasma. The guidance includes comments will be placed in the docket obtained by mail by calling CBER at 1– recommendations on optimal sources of and, except for those submitted as 800–835–4709 or 240–402–8010. See input plasma; manufacturing and ‘‘Confidential Submissions,’’ publicly the SUPPLEMENTARY INFORMATION section product quality, including product viewable at https://www.regulations.gov for electronic access to the draft characterization; packaging and or at the Dockets Management Staff guidance document. reconstitution; clinical studies; and between 9 a.m. and 4 p.m., Monday FOR FURTHER INFORMATION CONTACT: device submissions. through Friday. Jonathan McKnight, Center for Biologics DATES: Submit either electronic or • Confidential Submissions—To Evaluation and Research, Food and written comments on the draft guidance submit a comment with confidential Drug Administration, 10903 New by January 28, 2019 to ensure that the information that you do not wish to be Hampshire Ave., Bldg. 71, Rm. 7301, Agency considers your comment on this made publicly available, submit your Silver Spring, MD 20993–0002, 240– draft guidance before it begins work on comments only as a written/paper 402–7911. the final version of the guidance. submission. You should submit two SUPPLEMENTARY INFORMATION: copies total. One copy will include the ADDRESSES: You may submit comments I. Background on any guidance at any time as follows: information you claim to be confidential with a heading or cover note that states FDA is announcing the availability of Electronic Submissions ‘‘THIS DOCUMENT CONTAINS a draft document entitled Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The ‘‘Considerations for the Development of following way: Agency will review this copy, including Dried Plasma Products Intended for • Federal eRulemaking Portal: the claimed confidential information, in Transfusion; Draft Guidance for https://www.regulations.gov. Follow the its consideration of comments. The Industry.’’ Plasma is a critical instructions for submitting comments. second copy, which will have the component of early transfusion therapy Comments submitted electronically, claimed confidential information in the management of traumatic including attachments, to https:// redacted/blacked out, will be available hemorrhage. Plasma can replenish www.regulations.gov will be posted to for public viewing and posted on various coagulation proteins that are the docket unchanged. Because your https://www.regulations.gov. Submit consumed during the coagulopathy that comment will be made public, you are both copies to the Dockets Management can accompany traumatic injury. solely responsible for ensuring that your Staff. If you do not wish your name and Because plasma products intended for comment does not include any contact information to be made publicly transfusion such as fresh frozen plasma confidential information that you or a available, you can provide this (FFP), plasma frozen within 24 hours third party may not wish to be posted, information on the cover sheet and not after phlebotomy (PF24), and plasma such as medical information, your or in the body of your comments and you frozen within 24 hours after phlebotomy anyone else’s Social Security number, or must identify this information as held at room temperature up to 24 hours confidential business information, such ‘‘confidential.’’ Any information marked after phlebotomy (PF24, RT24) are as a manufacturing process. Please note as ‘‘confidential’’ will not be disclosed stored frozen, these products need to be that if you include your name, contact except in accordance with 21 CFR 10.20 thawed prior to transfusion. This limits

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or prevents the use of plasma in settings the collections of information in 21 CFR relying in part on the Agency’s previous where freezers and other support part 814 have been approved under findings of safety and effectiveness for equipment are unavailable (e.g. OMB control number 0910–0231. ROXICODONE (oxycodone HCl IR battlefields, remote locations, and other tablets (NDA 021011)) (Ref. 1). III. Electronic Access austere settings) and may lead to PMRS’s product contains excipients, delayed administration. Dried plasma Persons with access to the internet including a dye blend, that have (such as freeze-dried or spray-dried may obtain the draft guidance at either solubility in common solvents, plasma) offers the potential to address https://www.fda.gov/BiologicsBlood including water and ethanol, similar to these challenges by providing a product Vaccines/GuidanceCompliance the solubility of the active that is stable at ambient temperatures RegulatoryInformation/Guidances/ pharmaceutical ingredient (API). PMRS and can be rapidly reconstituted and default.htm or https:// contends that a solution prepared from transfused. www.regulations.gov. its product for subcutaneous or Recent clinical studies have Dated: October 25, 2018. intravenous injection will look demonstrated promising efficacy and Leslie Kux, relatively ‘‘impure’’ compared to a safety of dried plasma, particularly in solution prepared from Roxicodone and Associate Commissioner for Policy. military applications, and dried plasma will have a dark, opaque, products are available for limited use in [FR Doc. 2018–23637 Filed 10–29–18; 8:45 am] ‘‘contaminated-looking’’ appearance, Germany, South Africa, and France. BILLING CODE 4164–01–P providing both a ‘‘visual deterrent’’ and This guidance is intended to assist a ‘‘chemical deterrent’’ to abuse by manufacturers, sponsors, and applicants injection (Refs. 2 and 3).1 PMRS developing dried plasma products DEPARTMENT OF HEALTH AND HUMAN SERVICES provided in vitro data intended to show intended for transfusion in order to that a solution prepared for injection facilitate the availability of safe and Food and Drug Administration would have these qualities but provided effective dried plasma products in the no data or literature supporting the United States. [Docket No. FDA–2018–N–0188] conclusion that people who inject This draft guidance is being issued opioids would, in fact, be deterred from Denial of Hearing Request Regarding consistent with FDA’s good guidance injecting such a solution (Ref. 2). practices regulation (21 CFR 10.115). Proposal To Refuse To Approve a New PMRS also provided in vitro data The draft guidance, when finalized, will Drug Application for Oxycodone intended to demonstrate that its product represent the current thinking of FDA Hydrochloride Immediate-Release would be more difficult to grind into on considerations for the development Abuse-Deterrent Formulation, Oral particle sizes suitable for snorting of dried plasma products intended for Capsules, 5 Milligrams, 15 Milligrams, compared to ROXICODONE but transfusion. It does not establish any and 30 Milligrams; Order Refusing provided no data from studies in human rights for any person and is not binding Approval subjects to evaluate the pharmacokinetic on FDA or the public. You can use an AGENCY: Food and Drug Administration, or pharmacodynamic properties of the alternative approach if it satisfies the HHS. product following abuse via the nasal requirements of the applicable statutes 2 ACTION: Notice. route (Ref. 1). Nonetheless, PMRS and regulations. This guidance is not proposed labeling for its product subject to Executive Order 12866. SUMMARY: The Chief Scientist is denying representing that it has abuse-deterrent II. Paperwork Reduction Act of 1995 a request for a hearing regarding the properties (Ref. 4). On November 16, 2017, CDER issued This draft guidance refers to proposal by the Center for Drug a complete response letter to PMRS previously approved collections of Evaluation and Research (CDER) of the under § 314.110(a) (21 CFR 314.110(a)) information subject to review by the Food and Drug Administration (FDA or stating that the NDA could not be Office of Management and Budget Agency) to refuse to approve a new drug (OMB) under the Paperwork Reduction application submitted by 1 With respect to the purported ‘‘chemical Act of 1995 (44 U.S.C. 3501–3520). The Pharmaceutical Manufacturing Research Services, Inc. (PMRS) for oxycodone deterrent’’ aspect of its product, we note that collections of information in 21 CFR PMRS’s claims that its product resists physical and part 211 have been approved under hydrochloride (HCl) immediate-release chemical ‘‘extraction’’ appear to rest on a OMB control number 0910–0139; the (IR) capsules, 5 milligrams (mg), 15 mg, misunderstanding of how that term is used in the context of abuse-deterrent opioids. PMRS appears collections of information in 21 CFR and 30 mg in its present form. The Chief Scientist denies approval. to be using the term ‘‘extraction’’ to mean that it is part 312 have been approved under difficult to separate the API from the excipients in OMB control number 0910–0014; the DATES: The order is applicable October solution, not that it is difficult to prepare a solution collections of information in 21 CFR 30, 2018. that contains the API. In fact, PMRS’s data show that the oxycodone in its formulation can be readily FOR FURTHER INFORMATION CONTACT part 601 have been approved under : extracted in commonly available solvents into a OMB control number 0910–0338; the Nathan R. Sabel, Office of Scientific solution physically suitable for injection. These collections of information in 21 CFR Integrity, Food and Drug data show that more of the API could be extracted part 610 have been approved under Administration, 10903 New Hampshire from oxycodone HCl IR capsules (approximately 98 percent of the API) than from ROXICODONE OMB control numbers 0910–0116, Ave., Bldg. 1, Rm. 4206, Silver Spring, (approximately 90–91 percent) in both small and 0910–0139, and 0910–0338; the MD 20993, 301–796–8588. medium volume extraction and at ambient and high collections of information in 21 CFR SUPPLEMENTARY INFORMATION: temperatures (Refs. 1 and 2). part 630 have been approved under 2 While PMRS initially intended for the product I. Procedural Background to confer resistance to grinding to particle sizes OMB control number 0910–0116; the suitable for snorting (Ref. 7), PMRS has conceded, collections of information in 21 CFR PMRS submitted new drug based on the results of its testing, that the part 640 have been approved under application (NDA) 209155 for formulation should not be considered to have this OMB control number 0910–0116; the oxycodone HCl IR capsules, 5 mg, 15 property. See Ref. 2 at 12–13 (‘‘Because of the decrease in particle size distribution after grinding collections of information in 21 CFR mg, and 30 mg, under section 505(b)(2) as the drug product ages, resistance to grinding part 812 have been approved under of the Federal Food, Drug, and Cosmetic cannot be considered as one of the characteristics OMB control number 0910–0078; and Act (FD&C Act) (21 U.S.C. 355(b)(2)), of [PMRS’ product]’’).

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approved in its present form, describing for hearing under § 314.110(b)(3) on v. Hynson, Westcott & Dunning, Inc., the specific deficiencies, and, where whether there are grounds under section 412 U.S. 609, 620–21 (1973); Pineapple possible, recommending ways PMRS 505(d) of the FD&C Act for denying Growers Ass’n v. FDA, 673 F.2d 1083, might remedy these deficiencies (Ref. 5). approval of the NDA. 1085–86 (9th Cir. 1982) (holding that no The deficiencies cited include the On February 13, 2018, FDA published hearing is necessary unless ‘‘material following: a notice of opportunity for a hearing issues of fact’’ have been raised). (1) The application in its present form (NOOH) setting forth CDER’s proposal In determining whether there are is not approvable with the proposed to refuse to approve PMRS’s NDA for material issues of fact suitable for a labeling describing abuse-deterrent oxycodone HCl IR capsules in 5-mg, 15- hearing, FDA considers the specific properties, for multiple reasons. In mg, and 30-mg strengths (83 FR 6196). criteria set out in § 12.24(b) and grants particular, (a) the oxycodone in the The NOOH stated that, for the reasons a hearing only if the material submitted formulation can be readily extracted in described above and others described in in support of the request shows the commonly available solvents into a the complete response letter, notice is following: (1) There is a genuine and solution suitable for injection; (b) there given to PMRS and to all other substantial factual issue for resolution at were insufficient data showing the interested persons that FDA proposes to a hearing; a hearing will not be granted presence of excipients (including dye) issue an order refusing to approve the on issues of policy or law; 4 (2) the in the formulation can be expected to NDA because the application fails to factual issue can be resolved by deter abuse by injection; (c) the data meet the criteria for approval under available and specifically identified submitted were insufficient to show the section 505(d) of the FD&C Act, reliable evidence; a hearing will not be product was meaningfully resistant to including that: (1) PMRS has not granted on the basis of mere allegations manipulation for misuse or abuse; and provided sufficient data to show that the or denials or general descriptions of (d) there were not data submitted, product would be safe (section positions and contentions; (3) the data including data from pharmacokinetic 505(d)(1)); (2) PMRS has not shown that and information submitted, if and human abuse liability studies, fully the methods used in, and the facilities established at a hearing, would be characterizing the product’s abuse and controls used for, the manufacture, adequate to justify resolution of the potential by all relevant routes of abuse. processing, or packing of the product factual issue in the way sought by the Also, the data submitted were not are adequate to preserve its identity, requestor; a hearing will be denied if the sufficient to rule out the possibility that strength, quality, and purity (section Agency concludes that the data and the proposed formulation could result 505(d)(3)); and (3) the labeling PMRS information submitted are insufficient in a greater proportion of abuse by proposed for the product is false or to justify the factual determination injection of PMRS’s product compared misleading (section 505(d)(7)). urged, even if accurate; 5 (4) resolution to a conventional oxycodone IR PMRS submitted a request for a of the factual issue in the way sought by formulation. Abuse by injection carries hearing on February 15, 2018. PMRS the person is adequate to justify the greater risk of overdose and also submitted data, information, and action requested; a hearing will not be transmission of infectious disease than analysis in support of its hearing request granted on factual issues that are not abuse by other routes. on April 13, 2018 (April Submission).3 determinative with respect to the action (2) The safety and purity of the CDER submitted a proposed order on requested (e.g., if the Agency concludes excipients intended (but not shown) to June 13, 2018, and PMRS submitted a that the action would be the same even confer abuse-deterrent properties were Response to CDER’s Proposed Order on if the factual issue were resolved in the not adequately characterized, either by August 9, 2018 (August Submission), way sought); 6 (5) the action requested is the intended oral route of use or by consistent with regulations at expected routes of abuse, including § 314.200(g)(3) (21 CFR 314.200(g)(3)), 4 See also Georgia Pacific Corp. v. U.S. EPA, 671 injection. affording the hearing requestor 60 days F.2d 1235, 1241 (9th Cir. 1982) (finding that a (3) An overall evaluation of elemental party’s argument that a hearing is necessary to to respond to a proposed order. ‘‘sharpen the issues’’ or to ‘‘fully develop the facts’’ impurities in the final formulation and is not sufficient to justify a hearing); Citizens for a risk assessment for each heavy metal II. Statutory and Regulatory Allegan County, Inc. v. FPC, 414 F.2d 1125, 1128 (taking into consideration the maximum Framework Regarding 21 CFR Part 12 (D.C. Cir. 1969) (finding that ‘‘no evidentiary daily dose) were not provided. Hearings hearing is required where there is no dispute on the (4) The application did not fully facts and the agency proceeding involves only a Under § 12.24(a)(2) (21 CFR question of law.’’); and Sun Oil Co. v. FPC, 256 F.2d comply with the patent certification 12.24(a)(2)), the Agency reviews a 233, 240 (5th Cir. 1958), cert. denied, 358 U.S. 872 requirements applicable to applications hearing request to determine whether a (1958). submitted under section 505(b)(2) of the hearing has been justified. FDA has the 5 See also John D. Copanos & Sons, Inc. and Kanasco, Ltd. v. FDA, 854 F.2d 510, 522 (D.C. Cir. FD&C Act. authority to deny a hearing when it The complete response letter 1988) (‘‘The mere existence of some alleged factual appears from the hearing request that dispute between the parties will not defeat an describes additional deficiencies there are no material disputes of fact. otherwise properly supported motion for summary relating to the chemistry, See Costle v. Pacific Legal Found., 445 judgment; the requirement is that there be no genuine issue of material fact . . . Only disputes manufacturing, and controls (CMCs) and U.S. 198, 214 (1980) (a party seeking a current good manufacturing practice over facts that might affect the outcome of the suit hearing is required to meet a ‘‘threshold under the governing law will properly preclude the requirements that CDER determined burden of tendering evidence suggesting entry of summary judgment. Factual disputes that precluded approval of the application in the need for a hearing’’), reh’g denied, are irrelevant or unnecessary will not be counted.’’) (emphasis in original), quoting Anderson v. Liberty its present form (Ref. 5). The complete 446 U.S. 947 (1980), citing Weinberger response letter also noted that Lobby, Inc., 477 U.S. 242, 247–248 (1986) and Hynson, 412 U.S. at 620. satisfactory resolution of objectionable 3 Although timely filed, PMRS did not submit the 6 See also Hynson, 412 U.S. at 621 (1973) and inspection observations was required data, information, and factual analysis in the Dyestuffs & Chemicals, Inc. v. Flemming, 271 F.2d before the application could be required format (e.g., the submission lacks a 281, 286 (8th Cir. 1959) (‘‘Where the objections approved (Ref. 5). statement signed by the person responsible for such stated and the issues raised thereby are, even if true, submission that it includes in full all studies and legally insufficient, their effect is a nullity and no In response to the complete response information as required) (§ 314.200(d)(3)). The Chief objections have been stated. Congress did not letter, on November 17, 2017, PMRS Scientist has nevertheless reviewed PMRS’s April intend the governmental agencies created by it to submitted a request for an opportunity Submission in its entirety. Continued

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not inconsistent with any provision in is false or misleading in any particular abuse (Ref. 2). PMRS’s NDA provided in the FD&C Act or any FDA regulation; (see section 505(d)(7) of the FD&C Act; vitro data intended to show that a and (6) the requirements in other 21 CFR 314.125(b)(6)). On this basis, the solution prepared for injection would applicable regulations, e.g., 21 CFR November 16, 2017, complete response have such an appearance (Refs. 2 and 10.20, 12.21, 12.22, and 314.200, and in letter explained that the NDA in its 3).10 the NOOH are met. Similarly, current form is not approvable with the As CDER informed PMRS during the § 314.200(g) provides that a person proposed labeling describing abuse- application process, CDER considered requesting a hearing ‘‘may not rely upon deterrent properties. PMRS proposed this in vitro data unable to prove that allegations or denials but is required to labeling that includes multiple PMRS’s hypothesis is correct that set forth specific facts showing that statements that the product has individuals would actually be deterred there is a genuine and substantial issue properties that make it more difficult to by the appearance of a solution of fact that requires a hearing with manipulate for purposes of abuse and prepared from this formulation (Ref. 8). respect to a particular drug product misuse than a conventional formulation Although a solution prepared from specified in the request for hearing.’’ (Ref. 6). These statements include the PMRS’s product may appear a certain assertion that the product ‘‘is way based on the in vitro data provided, III. Analysis formulated with inactive ingredients PMRS has produced no scientific data Following review of the that make the capsule more difficult to or information to establish that people administrative record related to this manipulate for misuse and abuse’’ and who inject opioids would be less likely proceeding, the Chief Scientist 7 finds that ‘‘the results of this testing to do so because of this appearance or that PMRS has not raised a genuine and demonstrated that [the product] based upon knowledge that the solution substantial issue of fact justifying a capsules, in comparison to Roxicodone contains other components of the drug hearing regarding CDER’s proposal to tablets, have increased resistance to product in addition to the API. To refuse to approve the NDA in its present physical and chemical extraction.’’ (Ref. demonstrate that this formulation deters form.8 As further explained below, the 6).9 abuse, and thus to support the proposed Chief Scientist finds that a hearing Specifically, the complete response labeling for abuse-deterrent properties, would not otherwise be in the public letter explained that PMRS submitted CDER asked PMRS to provide evidence interest. Accordingly, the Chief Scientist ‘‘[n]o data . . . to support the proposed sufficient to prove that people who denies PMRS’s hearing request under hypothesis that the presence of abuse opioids by injection would be §§ 12.24(b) and 314.200(g) and orders excipients or dye in the solution would deterred from doing so based on the approval denied under section 505(d) of create a deterrence to intravenous solution’s appearance.11 the FD&C Act for PMRS’s NDA in its abuse’’ (Ref. 5). Generally, PMRS’s Critically, however, PMRS’s NDA and present form. hypothesis is that commonly used subsequent submissions in this methods of preparing a solution for proceeding contain no such data or A. PMRS’s Request for a Hearing Is injection, if applied to its product, will information on this critical question, Denied Because No Genuine and result in a solution that will look either from PMRS’s studies of its own Substantial Issue of Fact Exists ‘‘visually unappealing’’ compared to a product or from any potentially relevant Regarding the Lack of Sufficient, solution prepared from Roxicodone, and scientific literature. In lieu of Reliable Evidence Supporting PMRS’s will have a dark, opaque, scientifically valid evidence for the Proposed Labeling for Abuse-Deterrent ‘‘contaminated-looking’’ appearance proposition that appearance deters Properties that will serve as a ‘‘visual deterrent’’ to abuse, PMRS simply reiterates how the Among other bases for proposing to solution appears. PMRS states, deny PMRS’s NDA, the NOOH cites the 9 In its latest submission, PMRS appears to variously, that the ‘‘dark, significant requirement that FDA deny approval to propose revising its NDA labeling to include the color is visually unappealing for applications that propose labeling that statement ‘‘Oxycodone HCl IR ADF capsules should potential intravenous abuse’’ (Ref. 2); be prescribed knowing meaningful abuse-deterrent that ‘‘PMRS considers this visual properties have not been proven,’’ among other perform useless or unfruitful tasks.’’), cert. denied, labeling adjustments (August Submission at 5). deterrent effective in classifying drug 362 U.S. 911 (1960). First, PMRS cannot adjust the content of the NDA products as abuse deterrent’’ (id.); that 7 Under FDA Staff Manual Guide 1410.21, the that is the subject of this hearing process in the ‘‘[t]he use of an FD&C dye was Chief Scientist is authorized to perform all middle of the process itself. Among other reasons, considered a deterrent to abuse as it delegable functions of the Commissioner of Food the question this proceeding seeks to resolve is not and Drugs. (See FDA Staff Manual Guide 1410.21 whether PMRS might formulate an NDA that might ¶ 1.B.7). address some of the deficiencies cited in the NOOH. 10 According to CDER’s review, there remain 8 PMRS suggests that it has an absolute statutory Rather, this process seeks to determine whether the some questions concerning whether a solution right to a hearing on whether its NDA is approvable application PMRS submitted to CDER for review extracted from PMRS’s formulation would under section 505(c)(1)(B) of the FD&C Act without should be denied approval as CDER proposes. consistently have the dark or opaque appearance regard to whether it can satisfy the criteria for a PMRS may not change the substance of that observed in PMRS’s in vitro data. The appearance hearing set forth in FDA’s regulations, including the application during this proceeding. Second, given of an extracted solution of the product may vary, requirement that a person requesting a hearing must that the ‘‘ADF’’ abbreviation of the product name depending on the solvent used in extraction and demonstrate with data and analysis that there is a PMRS retains in this revised language stands for filtering methods employed by experienced abusers. genuine and substantial issue of fact that requires ‘‘Abuse Deterrent Formulation,’’ it is difficult to see However, for the purposes of this order, the Chief a hearing (April Submission at 6–7). PMRS is how this change, even if permissible, would remove Scientist assumes that the solution extracted from incorrect. FDA’s duly issued summary judgment the concern that is the primary focus of this order: PMRS’s formulation appears as a dark, opaque procedures have been consistently upheld and are that PMRS’s labeling represents that its product solution. fully compatible with section 505(c)(1)(B) of the possesses abuse-deterrent properties when the 11 CDER informed PMRS of the need for such FD&C Act. ‘‘It is well established that the statutory presence of such properties is not supported by evidence prior to PMRS’s submission of the NDA: grant of a public hearing is not absolute’’ substantial and reliable evidence. Consistent with ‘‘At this time, we are not aware of data that (Community Nutrition Inst. v. Young, 773 F.2d the regulations governing this 21 CFR part 12 support a deterrent effect based on the presence of 1356, 1364 (D.C. Cir. 1985)). FDA has the authority proceeding, this order evaluates PMRS’s NDA as it a dye in a formulation intended to be abuse- to deny a hearing when it appears from the was evaluated by CDER and not as PMRS might deterrent. Provide evidence that supports the submission of the party requesting a hearing that no seek to modify that application now. If PMRS concept that the incorporation of a dye into a substantial issue of fact is in dispute (Pineapple wishes to seek Agency review of a different NDA formulation imparts abuse-deterrent effects to that Growers Ass’n, 673 F.2d at 1085–86; Hynson, 412 at this juncture, the appropriate avenue would be formulation. A hypothetical argument that the U.S. at 621; Hess & Clark, Inc. v. FDA, 495 F.2d 975, to submit a new application through the standard presence of a dye will provide an abuse-deterrent 983 (D.C. Cir. 1974)). Agency process. effect is not sufficient to support labeling.’’ (Ref. 8).

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provides a visual deterrent once risks associated with injection of the co- form under section 505(d)(7) of the introduced to aqueous solution’’ (id.); extracted excipients.14 FD&C Act. that ‘‘the ready solubility of the The Chief Scientist concludes that FDA makes approval decisions, excipients matching the solubility PMRS has not created a genuine and including decisions regarding the profile of the API . . . maximiz[es] substantial issue of fact justifying a content of FDA-approved prescription deterrence by rendering [the product] hearing on this issue. As CDER drug labeling, based on a less attractive or rewarding for injection informed PMRS during the review comprehensive scientific evaluation of due to the inability to isolate the API process and in the complete response the available data and information, from the inactive ingredients for letter, PMRS has not provided evidence allowing only information for which injection’’ (Ref. 9); and that ‘‘it was very that demonstrate its product deters there is a scientific basis to be 15 important that excipients for this abuse. Despite requesting a factual included. As discussed above, no formulation have same [solubility] in hearing and offering in vitro data evidence establishes the proposition order to provide a chemical deterrent for intended to demonstrate how its that this formulation has the abuse- deterrent properties PMRS proposes to abuse’’ (Ref. 2).12 Despite these product looks in solution, PMRS has not include in its product labeling.16 The assertions and the in vitro data related provided sufficient and reliable data or absence of such evidence in support of to how the product looks in solution, information that creates a genuine and PMRS’s assertions is particularly PMRS has offered no evidence to substantial dispute of fact with respect to whether the appearance of such a problematic in light of the novel and establish that opioid-abusers will be highly speculative nature of PMRS’s deterred by the color or appearance of solution deters abuse in the manner PMRS proposes to describe in its abuse-deterrence hypothesis. It is well a solution prepared from PMRS’s understood that people suffering from formulation. labeling. PMRS may have submitted evidence to show what the product opioid use disorder—particularly PMRS has also failed to offer evidence looks like when prepared for injection people who abuse opioids by to establish its proposed conclusion but PMRS has not provided no clinical injection—routinely take extraordinary related to another deficiency cited in the evidence—or indeed any evidence—that risks in connection with their opioid complete response letter (Ref. 5), this appearance will deter abuse as abuse. The individuals who abuse specifically, PMRS’s failure to establish PMRS’s NDA represents in its proposed opioids by injection are known to be that its product formulation deters labeling. In addition, PMRS has failed to undeterred by such serious risks as abuse by snorting. Despite CDER’s provide sufficient evidence to establish disease transmission (including HIV and requests that human testing be that the product formulation deters hepatitis C) associated with needle- conducted to establish whether this abuse by snorting. As a result, there sharing, injection-site infections, formulation deters abuse by snorting exists no contested factual issue with overdose, and even death (Ref. 10). (see Refs. 5 and 8), PMRS declined to respect to the information available to Certain ‘‘street’’ opioids, such as black conduct such testing or to provide any demonstrate whether PMRS’s tar heroin, are commonly administered other information to show that its formulation possesses abuse-deterrent by injection despite their contaminated product functions to deter abuse by properties. Accordingly, the Chief appearance (Ref. 11) and despite the real snorting. Without human testing, or Scientist denies PMRS’s request for a risks associated with the unknown other appropriate data and information, factual hearing on this issue under composition and purity of such it is not possible to evaluate whether §§ 12.24(b) and 314.200(g) because there products (including, but not limited to, PMRS’s formulation has properties that exists no genuine and substantial issue the presence of contaminants). render it more or less likely to be of fact that would require such a hearing Against this backdrop, PMRS’s snorted.13 If the product were in fact to resolve. unsupported assertions and in vitro data less likely to be snorted, the product are insufficient to demonstrate that its could result in shifting the pathway of B. PMRS’s NDA Proposes Labeling That product formulation will deter abuse. abuse from snorting to injection. This Is False and Misleading Under Section Given the lack of data establishing the shift would increase the product’s 505(d)(7) of the FD&C Act and Is effect of PMRS’s formulation on its risks overall risks associated with abuse Therefore Appropriately Denied of abuse compared to a conventional compared to a conventional Approval formulation, the labeling statements formulation, both because abuse by Having found that that is no genuine PMRS has proposed suggesting that injection of any opioid carries and substantial question of fact with sufficient and reliable evidence exists additional risks particular to that route respect to whether PMRS’s proposed and establishes that PMRS’s formulation of abuse (Ref. 10) and because abuse by labeling is false or misleading, the Chief deters abuse would be false and injection of PMRS’s product in Scientist also finds that the Agency misleading. Thus, the proposed labeling particular carries unknown additional must therefore issue an order refusing to 15 See, e.g., 21 CFR 201.56(a)(1) (providing that approve PMRS’s NDA in its present the labeling of prescription drugs must contain a 12 We note that PMRS provided some data and summary of the essential scientific information information regarding its particular choice of dye 14 In June 2017 FDA sought withdrawal from the needed for the safe and effective use of the drug), blend, arguing that the blend it selected was ‘‘the market of OPANA ER (oxymorphone HCl ER tablets 21 CFR 201.56(a)(2) (providing that the labeling most visually deterring’’ of the colors evaluated ‘‘as (NDA 21610)) based on similar concerns (Ref. 12). must be informative and accurate and neither it resulted in a dark, opaque, ‘contaminated- Specifically, FDA requested that OPANA ER be promotional in tone nor false or misleading in any looking’ solution’’ (Ref. 2 at page 4). As this order withdrawn from the market after review of particular and that labeling must be updated when discusses, this data does not constitute sufficient postmarket data showed a significant shift in the new information becomes available that causes the evidence for the proposition that people who inject route of abuse from nasal to injection following the labeling to become inaccurate, false, or misleading), opioids can reasonably be expected to be ‘‘visually product’s reformulation. The reformulated product and 21 CFR 201.56(a)(3) (providing that labeling deterred’’ from doing so based on the appearance had been intended to deter abuse by injection and must be based whenever possible on data derived of the solution prepared for injection. snorting. Injection abuse of reformulated OPANA from human experience). 13 As previously noted, PMRS intended for its ER has been associated with serious adverse events, 16 As noted previously, PMRS’s claims that its formulation to confer resistance to grinding (for the including numerous cases of thrombotic product resists physical and chemical ‘‘extraction’’ purpose of snorting) but ultimately conceded that microangiopathy which are thought to have been appear to rest on a misunderstanding of how that the product has not been shown to have this related to injection of the excipients included to term is used in the context of abuse-deterrent property. See supra footnote 2. deter abuse (Refs. 12 and 13). opioids. See supra footnote 1.

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includes false and misleading abuse-deterrent opioids or PMRS’s for a product bearing a labeling claim statements suggesting that PMRS’s objections to those policies, except as that PMRS characterizes as a ‘‘more product is expected to be safer than a they apply to the question of whether appropriately limited claim about abuse conventional formulation with respect PMRS has raised a genuine and deterrence’’ (April Submission at 2). As to the risks of abuse when this substantial issue of fact which precludes stated above, PMRS has not presented conclusion remains unproven.17 CDER’s proposal to refuse to approve data, information, or analysis that Accordingly, the Chief Scientist has PMRS’s NDA.20 Instead, the Chief support a conclusion that its product is determined that PMRS has not Scientist’s order addresses only those approvable with its own proposed submitted data or information that can aspects of the PMRS submissions that labeling, rendering the question of support a conclusion that its product are at least potentially relevant to the whether ‘‘broader labeling statements’’ would deter abuse by injection and that question of whether PMRS has (April Submission at 2) should be PMRS’s proposed labeling is false and submitted data, information, or analysis withheld until supported by post- misleading under section 505(d)(7) in that raises a genuine and substantial market epidemiological data irrelevant the absence of such evidence. As a issue of fact justifying a hearing on the for purposes of this order.21 Even in its result, the Chief Scientist accepts issue of whether PMRS’s proposed August submission, PMRS continues to CDER’s proposal to refuse approval for abuse-deterrent labeling claims are false suggest that its product should be PMRS’s NDA in its present form. or misleading. labeled as possessing abuse-deterrent PMRS argues that CDER incorrectly properties, even naming its product C. PMRS’s Legal and Policy Arguments proposed refusing to approve its NDA ‘‘ADF’’ or Abuse Deterrent Formulation, Are Unavailing with the proposed abuse-deterrent while simultaneously arguing that no Instead of providing data and labeling because CDER applied what evidence can demonstrate such information addressing the absence of PMRS considers the flawed approach to properties pre-market (August genuine and substantial issues of fact the evaluation and labeling of abuse- Submission at 5).22 If PMRS is correct discussed in the previous sections, the deterrent products contained in FDA’s that such properties cannot be PMRS’s submissions consists largely of 2015 guidance for industry, ‘‘Abuse- established pre-market, then labeling its legal and policy objections to FDA’s Deterrent Opioids—Evaluation and product with abuse-deterrent properties approach to evaluating, labeling, and Labeling’’ (Ref. 14) (the Guidance). becomes even more transparently false approving opioids, as well as requests Specifically, PMRS argues that the and misleading. PMRS cannot have it for the Agency to take specific actions guidance’s emphasis on premarket both ways without admitting that their regarding other drug products premised studies (i.e., laboratory studies and proposed labeling lacks a scientific on PMRS’s proposed alternative policies human testing) is scientifically invalid basis. Further, even if FDA were to agree regarding opioids. These legal and and that FDA should only approve with PMRS that only labeling claims of policy arguments do not raise a genuine abuse-deterrent formulations with the type proposed by PMRS should be and substantial issue of fact justifying a abuse-deterrent labeling claims based on approved based on premarket studies, hearing. See § 12.24(b)(1) (‘‘A hearing post-market epidemiological data. this policy change would not alter the will not be granted on issues of policy PMRS contends that data from conclusion that PMRS has not raised a or law.’’).18 Furthermore, a hearing will premarket studies of abuse deterrence genuine and substantial issue of fact not be granted on the issue of whether cannot constitute ‘‘substantial justifying a hearing regarding CDER’s FDA should take regulatory actions evidence’’ that a product deters abuse proposal to refuse to approve PMRS’s regarding other drug products which are and therefore results in abuse-deterrent NDA with the labeling described in the 23 not the subject of the NOOH.19 labeling claims that are false and NDA. Accordingly, this order does not address misleading (April Submission at 2–5). The Chief Scientist finds PMRS’s APA the merits of FDA’s policies regarding PMRS further argues that CDER claim similarly irrelevant to the improperly treated compliance with the question of whether a hearing should be 17 During the review process, PMRS proposed that guidance approach as a requirement for granted. PMRS contends that, by its labeling include the following disclaimers: approval of abuse-deterrent labeling, recommending that PMRS follow the ‘‘Abuse of TRADENAME by injection, as well as by rather than merely as a set of the oral and nasal routes, is still possible,’’ and 21 recommendations, in violation of the For similar reasons, the Chief Scientist does not ‘‘there is no clinical evidence that TRADENAME address the merits of PMRS’s legal argument that has a reduced abuse liability compared to Administrative Procedure Act (APA) application of the approach described in the immediate-release oxycodone’’ (Ref. 6). These (April Submission at 5–7). The Chief Guidance raises concerns under the First disclaimers do not render PMRS’s other abuse- Scientist finds these arguments Amendment. PMRS contends that ‘‘[i]t cannot be deterrent labeling statements any less false and unconvincing and not relevant to the that an Agency can compel an applicant to forego misleading. For example, the first disclaimer a more limited truthful and non-misleading claim implies that the product has abuse-deterrent matter at hand. and to instead seek broader labeling claims that an properties, while stating that these properties do First, PMRS makes a policy argument applicant finds objectionable’’ (April Submission at not render the product abuse-proof. The second that FDA, by following the approach 4, footnote 4). Given that PMRS has not presented disclaimer conveys an assessment of the product’s described in the Guidance, routinely data, information, or analysis that support a abuse-deterrent properties is not based on data from conclusion that its product is approvable with what human studies but continues to suggest that the approves abuse-deterrent labeling PMRS characterizes as more limited claims product possesses these (unproven) properties. In claims that are too strong or overly regarding abuse-deterrence, PMRS’s First the context of the other labeling PMRS proposes broad based on premarket data. But this Amendment objections to broader labeling claims related to abuse-deterrence, these disclaimers, if argument does not raise an issue of fact are not relevant to this proceeding. anything, render the NDA’s proposed labeling even 22 regarding the approvability of an NDA See supra footnotes 6 and 16. more misleading. 23 We note that the Guidance was developed after 18 Courts have uniformly recognized that an considerable deliberation by the Agency and after administrative hearing need not be held to resolve 20 Similarly, this order does not address PMRS’s thorough consideration of stakeholder comments questions of law or policy (see Citizens for Allegan arguments that do not go to the specific deficiencies expressed at public meetings and submitted to the County, 414 F.2d 1125 (D.C. Cir. 1969); Sun Oil Co. cited in the complete response letter and the docket. If PMRS wants to provide further input on v. FPC, 256 F.2d 233, 240 (5th Cir.), cert denied, NOOH, such as its argument that its product, as the Guidance, there is already a mechanism in place 358 U.S. 872 (1958)). well as other opioid products, should not bear for PMRS to do so (see § 10.115(f)). A hearing on 19 § 314.200(g)(8) (‘‘A request for a hearing, and labeling consistent with chronic use and instead CDER’s proposal to refuse to approve PMRS’s NDA, any subsequent grant or denial of a hearing, applies should only be labeled for management of acute however, is not the proper forum for effecting only to the drug products named in [the NOOH]’’). pain. changes to FDA policy. See § 12.24(b)(1).

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approach to evaluating abuse-deterrent the opioid crisis.24 FDA has also held hearing and that PMRS’s proposed opioids described in the Guidance, and public hearings on topics relating to labeling containing abuse-deterrent by referring to the guidance in the opioid abuse, including to receive representations would be false and complete response letter and other stakeholder input on how FDA might, misleading under section 505(d)(7) of documents, CDER ‘‘effectively under its Risk Evaluation and Mitigation the FD&C Act. Although the complete converted a nonbinding guidance Strategy (REMS) authority, improve the response letter and NOOH describe document into a requirement for abuse- safe use of opioid analgesics by curbing additional deficiencies in PMRS’s NDA, deterrent labeling that has the force and overprescribing to decrease the it is not necessary to address these effect of the law’’ (April Submission at occurrence of new addictions and limit issues in this order because, even if 7). But challenging FDA’s recommended misuse and abuse of opioid analgesics.25 resolved in PMRS’s favor, PMRS’s NDA approach for study design to measure The Agency is also working to would still be refused approval in its abuse-deterrent effectiveness pre-market enhance prescriber and patient present form under section 505(d)(7) of is immaterial to the proposal to refuse awareness of the safe use of opioids. In the FD&C Act.27 PMRS’s specific NDA because PMRS 2017, FDA notified holders of approved has provided no evidence—either of the applications for IR opioid analgesics of IV. Findings and Order type FDA recommended or otherwise— the Agency’s determination that a REMS For the reasons described above, the that this formulation deters abuse. As a is necessary for IR opioid analgesics to Chief Scientist finds that PMRS has not result and as discussed in the previous ensure that the benefits of these drugs raised any genuine and substantial issue section, PMRS’s proposed labeling continue to outweigh the risks. Under of fact that would justify a hearing (see remains false and misleading because it this new policy, the IR opioid analgesics §§ 12.24(b)(1) and 314.200(g)(1)). represents abuse-deterrent properties for that are intended to be used in the Accordingly, PMRS’s request for a a formulation that has not been shown outpatient setting will be subject to the hearing is denied. The record to actually possess those properties. same REMS requirements as the conclusively shows that the approval In sum, the Chief Scientist concludes Extended-Release/Long-Acting opioid criteria set forth in section 505(d)(7) of that PMRS has raised no legal or policy analgesics. the FD&C Act have not been met. argument that alters the determinations In addition, the Agency is Therefore, under section 505(d) of the discussed in the previous sections. undertaking a study to improve its FD&C Act of the FD&C Act, the Chief understanding of prescriber beliefs D. A Hearing is not Otherwise in the Scientist hereby denies approval to relating to use of opioid products with PMRS’s NDA in its present form. Public Interest abuse-deterrent properties.26 The In its August Submission, PMRS Agency is evaluating currently-used V. References argues that a Part 12 hearing would be nomenclature for such products, The following references marked with ‘‘otherwise in the public interest’’ including by surveying doctors to better an asterisk (*) are on display in the within the meaning of § 314.200(g)(6) in understand how they perceive these Dockets Management Staff (HFA–305), order to resolve broader policy issues terms and to assess the clinical Food and Drug Administration, 5630 related to opioid abuse. The Chief understanding that has developed Fishers Lane, Rm. 1061, Rockville, MD Scientist disagrees and finds in her around products with labeling for 20852, and are available for reviewing discretion that a Part 12 hearing on this abuse-deterrent properties. Further, by interested persons between 9 a.m. NDA would not otherwise be in the FDA is continuously monitoring the and 4 p.m., Monday through Friday; public interest. safety of approved opioid products they are also available electronically at As discussed above, PMRS’s based on post-market information, https://www.regulations.gov. The submissions raise arguments relevant to including through a focus on improving reference without an asterisk is not on FDA’s regulation of opioid products and post-market data collection in this area. public display at https:// to the crisis of opioid abuse, generally. As these examples show, the Agency www.regulations.gov because it has For example, PMRS argues that the is working to address the crisis of opioid copyright restriction. References ‘‘emphasis on so-called abuse-deterrent addiction and abuse and recognizes the without asterisks are available for formulations and labeling in response to importance of seeking public comment viewing only at the Dockets the opioid epidemic has resulted in the and participation relevant to FDA’s Management Staff. FDA has verified the market entry of additional misbranded opioid-related policies. However, the website addresses, as of the date this products’’ and that ‘‘[s]uch false and Chief Scientist does not believe that a document publishes in the Federal misleading labeling serves only to Part 12 hearing on the approvability of Register, but websites are subject to confuse prescribers and patients about PMRS’s NDA is an appropriate forum to change over time. what the product is and . . . is not’’ address such concerns and finds in her (April Submission at 4). In its * 1. Clinical Review, Cross-Discipline Deputy discretion that such a hearing would not Director Review and Summary Division submissions, PMRS also requests that be in the public interest. Director Review, NDA 209155. FDA take specific regulatory action E. Additional Issues Not Decided by * 2. ‘‘Module 3 Quality, 3.2.P.2.2 Drug regarding several other specific opioid Product,’’ PMRS Inc., NDA 209155. products. This Order * 3. ‘‘Module 2 Common Technical The Agency continues to take a As described above, the Chief Document Summaries,’’ PMRS, NDA variety of steps to address the public Scientist has determined that PMRS has 209155. health crisis created by opioid abuse not raised a genuine and substantial and the resulting addiction and death. issue of fact that would warrant a 27 ‘‘A hearing will be denied if the Commissioner concludes that the data and information submitted For example, in May 2017, the are insufficient to justify the factual determination Commissioner of Food and Drugs (the 24 See 82 FR 58572 (December 13, 2017). urged even if accurate.’’ § 12.24(b)(3). Furthermore, Commissioner) announced the 25 Id. ‘‘[a] hearing will not be granted on factual issues establishment of an Opioid Policy 26 See Scott Gottlieb, M.D., Commissioner of Food that are not determinative with respect to the action and Drugs, Remarks Delivered Before FDA’s requested, e.g., if the Commissioner concludes that Steering Committee to explore and Scientific Meeting on Opioids (July 10, 2017), the action would be the same even if the factual develop additional approaches or available at https://www.fda.gov/newsevents/ issue were resolved in the way sought[.]’’ strategies FDA could deploy to combat speeches/ucm566189.htm. § 12.24(b)(4).

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* 4. Proposed labeling for oxycodone HCl IR advisory-committees/nursing/ DEPARTMENT OF HEALTH AND capsules, PMRS, NDA 209155 (Dec. index.html. HUMAN SERVICES 2017). * 5. Complete Response letter, NDA 209155 DATES: November 19, 2018, 8:30 a.m.– National Institutes of Health (November 16, 2017). 4:15 p.m. ET. * 6. ‘‘Filing Communication Responses,’’ ADDRESSES: This meeting will be held Government-Owned Inventions; PMRS, NDA 209155. by teleconference and webinar. The Availability for Licensing * 7. ‘‘Request for Priority Review Designation,’’ PMRS, NDA 209155. conference call-in number is 1–888– 455–0640; passcode: HRSA COUNCIL. AGENCY: National Institutes of Health, * 8. ‘‘Memorandum of Meeting Minutes’’ for HHS. Type B, Pre-NDA, July 11, 2016 The webinar link is https:// teleconference (August, 8, 2016). hrsa.connectsolutions.com/nacnep/. ACTION: Notice. * 9. ‘‘NDA 209155 CMC Information Request FOR FURTHER INFORMATION CONTACT: SUMMARY: 5–25–17,’’ PMRS, NDA 209155. Tracy L. Gray, MBA, MS, RN, Division The invention listed below is * 10. Centers for Disease Control, ‘‘Integrated of Nursing and Public Health, Bureau of jointly owned by an agency of the U.S. Prevention Services for HIV Infection, Health Workforce, HRSA, 5600 Fishers Government with Pontificia Viral Hepatitis, Sexually Transmitted Universidad Catolica de Chile and is Diseases, and Tuberculosis for Persons Lane, 11N112, Rockville, Maryland 20857; 301–443–3346; or DScott1@ available for licensing to achieve Who Use Drugs Illicitly: Summary expeditious commercialization of Guidance From the CDC and the U.S. hrsa.gov. Department of Health and Human results of federally-funded research and SUPPLEMENTARY INFORMATION: Services,’’ Morbidity and Mortality NACNEP development. Foreign patent Weekly Report, vol. 61, pp. 1–40, 2012. provides advice and recommendations applications are filed on selected * 11. National Institute on Drug Abuse, to the Secretary of Health and Human inventions to extend market coverage ‘‘What is heroin and how is it used?’’, Services (Secretary) and the U.S. for companies and may also be available available at https://www.drugabuse.gov/ Congress on policy matters arising in for licensing. publications/research-reports/heroin/ the administration of Title VIII of the FOR FURTHER INFORMATION CONTACT: what-heroin (accessed June 13, 2018). Public Health Service (PHS) Act, as * 12. FDA News Release, ‘‘FDA requests Licensing information and copies of the amended, including the range of issues U.S. patent application listed below removal of Opana ER for risks related to relating to nurse supply, education, and abuse’’ (June 8, 2017), available at may be obtained by communicating https://www.fda.gov/NewsEvents/ practice improvements. NACNEP with Ami Gadhia, JD, LL.M., CLP, Newsroom/PressAnnouncements/ provides an annual report to the Technology Transfer and Patenting ucm562401.htm. Secretary and Congress describing the Specialist, National Center for 13. Hunt, R. et al., ‘‘A Mechanistic activities of NACNEP, including Advancing Translational Sciences, NIH, Investigation of Thrombotic findings and recommendations made by 9800 Medical Center Drive, Rockville, Microangiopathy Associated with IV NACNEP concerning the activities MD 20850, Phone: 301–217–6098, or Abuse of Opana ER,’’ Blood, Feb. 16, under this title. 2017. email [email protected]. A signed During the November 19, 2018, Confidential Disclosure Agreement will * 14. FDA Guidance for Industry ‘‘Abuse- meeting, NACNEP will continue Deterrent Opioids—Evaluation and be required to receive copies of Labeling,’’ available at https:// discussing areas where nursing can take unpublished patent applications. the lead in the transition of the health www.fda.gov/downloads/Drugs/ SUPPLEMENTARY INFORMATION: Guidances/UCM334743.pdf. care system to value-based care through improvements to nurse education and Technology description follows. Dated: October 25, 2018. practice, to advance the development of c-Abl Tyrosine Kinase Inhibitory Denise Hinton, its 15th Report. In addition, the Compounds and Methods of Chief Scientist. members will discuss strategic priorities Manufacture and Use [FR Doc. 2018–23710 Filed 10–29–18; 8:45 am] and future directions for the Council Description of Technology BILLING CODE 4164–01–P and discuss possible topics for its 16th Report. Agenda items are subject to The invention includes compounds change as priorities dictate. Refer to the that inhibit c-Abl tyrosine kinase, and DEPARTMENT OF HEALTH AND NACNEP website for any updated methods of making them which include HUMAN SERVICES information concerning the meeting. administering (i) a therapeutically Members of the public will have the effective amount of the compound or a Health Resources and Services stereoisomer, tautomer, Administration opportunity to provide comments. Public participants may submit written pharmaceutically acceptable salt, solvate, or prodrug thereof; or (ii) a Meeting of the National Advisory statements in advance of the scheduled meeting. Oral comments will be therapeutically effective amount of the Council on Nurse Education and pharmaceutical compositions to a Practice honored in the order they are requested and may be limited as time allows. patient with the disease which involves AGENCY: Health Resources and Services Requests to make oral comments or c-Abl tyrosine kinase, including the Administration (HRSA), Department of provide written statements to NACNEP overexpression of it. In some Health and Human Services (HHS). should be sent to Ms. Tracy L. Gray, embodiments, the compound inhibits c- ACTION: Notice. Designated Federal Official, using the Abl tyrosine kinase by binding to an contact information above at least 3 allosteric site of the c-Abl tyrosine SUMMARY: The National Advisory business days prior to the meeting. kinase. In some embodiments, the Council on Nurse Education and compound binds to a myristate pocket Practice (NACNEP or the Council) has Amy P. McNulty, of the c-Abl tyrosine kinase. scheduled a public meeting. Information Acting Director, Division of the Executive This technology is available for about NACNEP and the agenda for this Secretariat. licensing for commercial development meeting can be found on the NACNEP [FR Doc. 2018–23685 Filed 10–29–18; 8:45 am] in accordance with 35 U.S.C. 209 and 37 website at https://www.hrsa.gov/ BILLING CODE 4165–15–P CFR part 404, as well as for further

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development and evaluation under a property such as patentable material, 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., research collaboration. and personal information concerning as amended. The contract proposals and individuals associated with the grant the discussions could disclose Potential Commercial Applications applications, the disclosure of which confidential trade secrets or commercial • Novel therapeutics for would constitute a clearly unwarranted property such as patentable material, neurodegenerative diseases AND other invasion of personal privacy. and personal information concerning indications which involve c-Abl kinase Name of Committee: National Institute of individuals associated with the contract (e.g., lysosomal storage disorders, Child Health and Human Development proposals, the disclosure of which cancers, etc.). Special Emphasis Panel; NICHD K99 would constitute a clearly unwarranted Competitive Advantages Teleconference Review. invasion of personal privacy. Date: November 29, 2018. Name of Committee: National Institute on • Novel compounds that have a Time: 2:00 p.m. to 4:00 p.m. Aging Special Emphasis Panel; Second Stage commercial advantage over those Agenda: To review and evaluate grant Review. applications. currently known because they are able Date: November 19, 2018. Place: National Institutes of Health, 6710B to selectively bind to c-Abl at an Time: 8:30 a.m. to 4:00 p.m. Rockledge Drive, Bethesda, MD 20894 allosteric site, can cross the blood-brain Agenda: To review and evaluate contract (Telephone Conference Call). barrier, and show robust efficacy in proposals. Contact Person: Helen Huang, Scientific Place: National Institute on Aging, several neurodegenerative models. All Review Branch (SRB), DER, Eunice Kennedy Gateway Building, Suite 2W200, 7201 of this allows them to potentially treat Shriver National Institute of Child Health Wisconsin Avenue, Bethesda, MD 20892. neurodegenerative diseases, cancer etc. and Human Development, NIH, DHHS, Contact Person: Kimberly Firth, Ph.D., 6710B Rockledge Drive, Rm. 2125B, National Institutes of Health, National Development Stage Bethesda, MD 20817, 301–435–8380, Institute on Aging, Gateway Building, 7201 • [email protected]. Pre-Clinical (in vivo validation). Wisconsin Avenue, Suite 2C212, Bethesda, Inventors Name of Committee: National Institute of MD 20892, 301–402–7702, firthkm@ Child Health and Human Development mail.nih.gov. • Juan Marugan, Marc Ferrer, Noel Special Emphasis Panel; Pediatric Critical (Catalogue of Federal Domestic Assistance Care and Trauma Scientist Development Southall, Andres Dulcey, Xin Hu, Program Nos. 93.866, Aging Research, Program (K12) Teleconference Review. Christopher Dextras, Daniel Talley, National Institutes of Health, HHS) Alejandra Alvarez, Silvana Zanlungo. Date: December 3, 2018. Intellectual Property: 1. C-ABL Time: 2:00 p.m. to 4:00 p.m. Dated: October 24, 2018. Agenda: To review and evaluate grant Melanie J. Pantoja, TYROSINE KINASE INHIBITORY applications. COMPOUND EMBODIMENTS AND Program Analyst, Office of Federal Advisory Place: National Institutes of Health, 6710B Committee Policy. METHODS OF MAKING AND USING Rockledge Drive, Bethesda, MD 20892 THE SAME’’ U.S. Provisional Patent (Telephone Conference Call). [FR Doc. 2018–23614 Filed 10–29–18; 8:45 am] Application NO. 62/641,126 filed on Contact Person: Helen Huang, Scientific BILLING CODE 4140–01–P March 9, 2018 (HHS Ref. No. E–252– Review Branch (SRB), DER, Eunice Kennedy 2017). Shriver National Institute of Child Health Licensing Contact: Ami Gadhia, JD, and Human Development, NIH, DHHS, DEPARTMENT OF HEALTH AND LL.M., CLP, 301–217–6098; 6710B Rockledge Drive, Rm. 2125B, HUMAN SERVICES Bethesda, MD 20817, 301–435–8380, [email protected]. [email protected]. National Institutes of Health Dated: September 25, 2018. (Catalogue of Federal Domestic Assistance Lillianne M. Portilla Weingarten, Program Nos. 93.864, Population Research; National Institute of Arthritis and Technology Development Coordinator, 93.865, Research for Mothers and Children; Musculoskeletal and Skin Diseases; National Center for Advancing Translational 93.929, Center for Medical Rehabilitation Notice of Closed Meetings Sciences. Research; 93.209, Contraception and Infertility Loan Repayment Program, National Pursuant to section 10(d) of the [FR Doc. 2018–23616 Filed 10–29–18; 8:45 am] Institutes of Health, HHS) Federal Advisory Committee Act, as BILLING CODE 4140–01–P Dated: October 24, 2018. amended, notice is hereby given of the Ronald J. Livingston, Jr., following meetings. The meetings will be closed to the DEPARTMENT OF HEALTH AND Program Analyst, Office of Federal Advisory public in accordance with the HUMAN SERVICES Committee Policy. provisions set forth in sections [FR Doc. 2018–23615 Filed 10–29–18; 8:45 am] National Institutes of Health 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., BILLING CODE 4140–01–P as amended. The grant applications and Eunice Kennedy Shriver National the discussions could disclose confidential trade secrets or commercial Institute of Child Health and Human DEPARTMENT OF HEALTH AND property such as patentable material, Development; Notice of Closed HUMAN SERVICES Meetings and personal information concerning National Institutes of Health individuals associated with the grant Pursuant to section 10(d) of the applications, the disclosure of which Federal Advisory Committee Act, as National Institute on Aging; Notice of would constitute a clearly unwarranted amended, notice is hereby given of the Closed Meeting invasion of personal privacy. following meetings. The meetings will be closed to the Pursuant to section 10(d) of the Name of Committee: National Institute of public in accordance with the Federal Advisory Committee Act, as Arthritis and Musculoskeletal and Skin provisions set forth in sections Diseases Special Emphasis Panel; Ancillary amended, notice is hereby given of the Studies Application Review. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., following meeting. Date: November 2, 2018. as amended. The grant applications and The meeting will be closed to the Time: 12:00 p.m. to 5:00 p.m. the discussions could disclose public in accordance with the Agenda: To review and evaluate grant confidential trade secrets or commercial provisions set forth in sections applications.

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Place: National Institute of Arthritis, Musculoskeletal and Skin Diseases Research, Public Participation and Request for Musculoskeletal and Skin Diseases, 6701 National Institutes of Health, HHS) Comments Democracy Boulevard, Room 814, Bethesda, Dated: October 24, 2018. MD 20892 (Telephone Conference Call). This Notice relies on the authority of Contact Person: Helen Lin, Ph.D., Sylvia L. Neal, the Paperwork Reduction Act of 1995; Scientific Review Officer, Scientific Review Program Analyst, Office of Federal Advisory 44 U.S.C. chapter 35, as amended. An Branch, National Institute of Arthritis, Committee Policy. ICR is an application to OIRA seeking Musculoskeletal and Skin Diseases, 6701 [FR Doc. 2018–23613 Filed 10–29–18; 8:45 am] the approval, extension, or renewal of a Democracy Boulevard, Suite 800, Bethesda, BILLING CODE 4140–01–P Coast Guard collection of information MD 20892, 301–594–4952, linh1@ mail.nih.gov. (Collection). The ICR contains This notice is being published less than 15 information describing the Collection’s days prior to the meeting due to the timing purpose, the Collection’s likely burden limitations imposed by the review and DEPARTMENT OF HOMELAND on the affected public, an explanation of funding cycle. SECURITY the necessity of the Collection, and other important information describing Name of Committee: National Institute of Coast Guard Arthritis and Musculoskeletal and Skin the Collection. There is one ICR for each Diseases Special Emphasis Panel; NIAMS Collection. Skin P30 Review Meeting. [Docket No. USCG–2018–0879] The Coast Guard invites comments on Date: November 5–6, 2018. whether this ICR should be granted Information Collection Request to Time: 8:00 a.m. to 2:00 p.m. based on the Collection being necessary Agenda: To review and evaluate grant Office of Management and Budget; for the proper performance of applications. OMB Control Number: 1625–0088 Place: Bethesda North Marriott Hotel & Departmental functions. In particular, Conference Center, 5701 Marinelli Road, AGENCY: Coast Guard, DHS. the Coast Guard would appreciate Bethesda, MD 20852. ACTION: Sixty-day notice requesting comments addressing: (1) The practical Contact Person: Kan Ma, Ph.D., Scientific comments. utility of the Collection; (2) the accuracy Review Officer, Scientific Review Branch, of the estimated burden of the National Institute of Arthritis, SUMMARY: Collection; (3) ways to enhance the Musculoskeletal and Skin Diseases, 6701 In compliance with the Democracy Boulevard, Suite 814, Bethesda, Paperwork Reduction Act of 1995, the quality, utility, and clarity of MD 20892, 301–451–4838, mak2@ U.S. Coast Guard intends to submit an information subject to the Collection; mail.nih.gov. Information Collection Request (ICR) to and (4) ways to minimize the burden of This notice is being published less than 15 the Office of Management and Budget the Collection on respondents, days prior to the meeting due to the timing (OMB), Office of Information and including the use of automated limitations imposed by the review and Regulatory Affairs (OIRA), requesting an collection techniques or other forms of funding cycle. extension of its approval for the information technology. In response to Name of Committee: National Institute of following collection of information: your comments, we may revise this ICR Arthritis and Musculoskeletal and Skin 1625–0088, Voyage Planning for Tank or decide not to seek an extension of Diseases Special Emphasis Panel; Training Barge Transits in the Northeast United approval for the Collection. We will Grants Review. Date: November 14, 2018. States. Our ICR describes the consider all comments and material Time: 10:00 a.m. to 1:30 p.m. information we seek to collect from the received during the comment period. Agenda: To review and evaluate grant public. Before submitting this ICR to We encourage you to respond to this applications. OIRA, the Coast Guard is inviting request by submitting comments and Place: 6701 Democracy Boulevard, Suite comments as described below. related materials. Comments must 820, Scientific Review Branch, National DATES: Comments must reach the Coast contain the OMB Control Number of the Institute of Arthritis, Musculoskeletal and Guard on or before December 31, 2018. ICR and the docket number of this Skin Diseases, Bethesda, MD 20892 request, [USCG–2018–0879], and must (Telephone Conference Call). ADDRESSES: You may submit comments be received by December 31, 2018. Contact Person: Yasuko Furumoto, Ph.D., identified by Coast Guard docket Scientific Review Officer, Scientific Review number [USCG–2018–0879] to the Coast Submitting Comments Branch, National Institute of Arthritis, Guard using the Federal eRulemaking We encourage you to submit Musculoskeletal and Skin Diseases 6701 Portal at https://www.regulations.gov. Democracy Boulevard, Suite 820, Bethesda, comments through the Federal MD 20892, 301–827–7835, See the ‘‘Public participation and eRulemaking Portal at https:// [email protected]. request for comments’’ portion of the www.regulations.gov. If your material Name of Committee: National Institute of SUPPLEMENTARY INFORMATION section for cannot be submitted using https:// Arthritis and Musculoskeletal and Skin further instructions on submitting www.regulations.gov, contact the person Diseases Special Emphasis Panel; MSK P30 comments. in the FOR FURTHER INFORMATION Review Meeting. A copy of the ICR is available through CONTACT section of this document for Date: November 15–16, 2018. the docket on the internet at https:// Time: 8:00 a.m. to 6:30 p.m. alternate instructions. Documents www.regulations.gov. Additionally, mentioned in this notice, and all public Agenda: To review and evaluate grant copies are available from: Commandant applications. comments, are in our online docket at Place: Canopy by Hilton, 940 Rose Avenue, (CG–612), ATTN: Paperwork Reduction https://www.regulations.gov and can be North Bethesda, Bethesda, MD 20852. Act Manager, U.S. Coast Guard, 2703 viewed by following that website’s Contact Person: Yin Liu, MD, Ph.D., Martin Luther King Jr Ave. SE, STOP instructions. Additionally, if you go to Scientific Review Branch, National Institute 7710, Washington, DC 20593–7710. the online docket and sign up for email of Health, National Institute of Arthritis, FOR FURTHER INFORMATION CONTACT: Mr. alerts, you will be notified when Musculoskeletal and Skin Diseases, 6701 Anthony Smith, Office of Information Democracy Boulevard, Suite 824, Bethesda, comments are posted. MD 20892, 301–594–8919, liuy@ Management, telephone 202–475–3532, We accept anonymous comments. All mail.nih.gov. or fax 202–372–8405, for questions on comments received will be posted (Catalogue of Federal Domestic Assistance these documents. without change to https:// Program Nos. 93.846, Arthritis, SUPPLEMENTARY INFORMATION: www.regulations.gov and will include

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any personal information you have ACTION: Thirty-day notice requesting necessary for the proper performance of provided. For more about privacy and comments. Departmental functions. In particular, the docket, you may review a Privacy the Coast Guard would appreciate Act notice regarding the Federal Docket SUMMARY: In compliance with the comments addressing: (1) The practical Management System in the March 24, Paperwork Reduction Act of 1995 the utility of the Collection; (2) the accuracy 2005, issue of the Federal Register (70 U.S. Coast Guard is forwarding an of the estimated burden of the FR 15086). Information Collection Requests (ICR), Collection; (3) ways to enhance the abstracted below, to the Office of quality, utility, and clarity of Information Collection Request Management and Budget (OMB), Office information subject to the Collection; Title: Voyage Planning for Tank Barge of Information and Regulatory Affairs and (4) ways to minimize the burden of Transits in the Northeast United States. (OIRA), requesting an extension of its the Collection on respondents, OMB Control Number: 1625–0088. approval for the following collection of including the use of automated Summary: The information collection information: 1625–0015, Bridge Permit collection techniques or other forms of requirement for a voyage plan serves as Application Guide. Our ICR describes information technology. These a preventive measure and assists in the information we seek to collect from comments will help OIRA determine ensuring the successful execution and the public. Review and comments by whether to approve the ICR referred to completion of a voyage in the First OIRA ensure we only impose paperwork in this Notice. Coast Guard District. This rule (33 CFR burdens commensurate with our We encourage you to respond to this 165.100) applies to primary towing performance of duties. request by submitting comments and vessels engaged in towing tank barges DATES: Comments must reach the Coast related materials. Comments to Coast carrying petroleum oil in bulk as cargo. Guard and OIRA on or before November Guard or OIRA must contain the OMB Need: Section 311 of the Coast Guard 29, 2018. Control Number of the ICR. They must Authorization Act of 1998, Public Law ADDRESSES: You may submit comments also contain the docket number of this 105–383, 33 U.S.C. 1231, and 46 U.S.C. identified by Coast Guard docket request, [USCG–2018–0497], and must 3719 authorize the Coast Guard to number [USCG–2018–0497] to the Coast be received by November 29, 2018. promulgate regulations for towing vessel Guard using the Federal eRulemaking Submitting Comments and barge safety for the waters of the Portal at https://www.regulations.gov. We encourage you to submit Northeast subject to the jurisdiction of Alternatively, you may submit comments through the Federal the First Coast Guard District. The comments to OIRA using one of the eRulemaking Portal at https:// regulation is contained in 33 CFR following means: www.regulations.gov. If your material 165.100. The information for a voyage (1) Email: dhsdeskofficer@ cannot be submitted using https:// plan will provide a mechanism for omb.eop.gov. www.regulations.gov, contact the person assisting vessels towing tank barges to (2) Mail: OIRA, 725 17th Street NW, in the FOR FURTHER INFORMATION identify those specific risks, potential Washington, DC 20503, attention Desk CONTACT section of this document for equipment failures, or human errors that Officer for the Coast Guard. alternate instructions. Documents may lead to accidents. A copy of the ICR is available through mentioned in this notice, and all public Forms: None. the docket on the internet at https:// comments, are in our online docket at Respondents: Owners and operators www.regulations.gov. Additionally, https://www.regulations.gov and can be of towing vessels. copies are available from: Commandant viewed by following that website’s Frequency: On occasion. (CG–612), ATTN: Paperwork Reduction instructions. Additionally, if you go to Hour Burden Estimate: The estimated Act Manager, U.S. Coast Guard, 2703 the online docket and sign up for email burden has increased from 880 hours to Martin Luther King Jr Ave. SE, STOP alerts, you will be notified when 937 hours a year due to an increase in 7710, Washington, DC 20593–7710. comments are posted. the estimated annual number of FOR FURTHER INFORMATION CONTACT: Mr. We accept anonymous comments. All responses. Anthony Smith, Office of Information comments received will be posted Authority: The Paperwork Reduction Act Management, telephone 202–475–3532, without change to https:// of 1995; 44 U.S.C. chapter 35, as amended. or fax 202–372–8405, for questions on www.regulations.gov and will include these documents. Dated: October 25, 2018. any personal information you have SUPPLEMENTARY INFORMATION: James D. Roppel, provided. For more about privacy and Acting Chief, U.S. Coast Guard, Office of Public Participation and Request for the docket, you may review a Privacy Information Management. Comments Act notice regarding the Federal Docket [FR Doc. 2018–23639 Filed 10–29–18; 8:45 am] Management System in the March 24, This Notice relies on the authority of 2005, issue of the Federal Register (70 BILLING CODE 9110–04–P the Paperwork Reduction Act of 1995; FR 15086). 44 U.S.C. chapter 35, as amended. An OIRA posts its decisions on ICRs ICR is an application to OIRA seeking DEPARTMENT OF HOMELAND online at https://www.reginfo.gov/ the approval, extension, or renewal of a SECURITY public/do/PRAMain after the comment Coast Guard collection of information period for each ICR. An OMB Notice of Coast Guard (Collection). The ICR contains Action on each ICR will become information describing the Collection’s available via a hyperlink in the OMB purpose, the Collection’s likely burden Control Number: 1625–0015. [Docket No. USCG–2018–0497] on the affected public, an explanation of Previous Request for Comments Collection of Information Under the necessity of the Collection, and Review by Office of Management and other important information describing This request provides a 30-day Budget; OMB Control Number: 1625– the Collection. There is one ICR for each comment period required by OIRA. The 0015 Collection. The Coast Guard invites Coast Guard published the 60-day comments on whether this ICR should notice (83 FR 42522, August 22, 2018) AGENCY: Coast Guard, DHS. be granted based on the Collection being required by 44 U.S.C. 3506(c)(2). That

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Notice elicited no comments. FOR FURTHER INFORMATION CONTACT: contacting the Commission’s TDD Accordingly, no changes have been Karen N. Stone, (703) 787–1810 or email terminal on (202) 205–1810. made to the Collections. [email protected]. SUPPLEMENTARY INFORMATION: The Information Collection Request SUPPLEMENTARY INFORMATION: This Commission instituted this investigation notice is to inform the interested public on August 1, 2017, based on a complaint Title: Bridge Permit Application that BSEE, Oil Spill Preparedness and supplement, filed on behalf of Guide. Division (OSPD), Response Research Hologic, Inc. of Marlborough, OMB Control Number: 1625–0015. Branch will be conducting a public Massachusetts (‘‘Hologic’’). 82 FR Summary: The collection of meeting to discuss advancement of a 35829–24 (Aug. 1, 2017). The information is a request for a bridge low-emission spray combustion unit complaint, as supplemented, alleges permit submitted as an application for being designed to burn water-in-oil violations of section 337 based upon the approval by the Coast Guard of any emissions. System integration including importation into the United States, the proposed bridge project. An applicant platform/barge configurations will be sale for importation, and the sale within must submit to the Coast Guard a letter discussed to ready the unit towards use the United States after importation of of application along with letter-size in oil spill cleanup operations. certain x-ray breast imaging and drawings (plans) and maps showing the components thereof by reason of proposed project and its location. Dated: October 24, 2018. Scott A. Angelle, infringement of certain claims of U.S. Need: 33 U.S.C. 401, 491, and 525 Patent No. 7,831,296 (‘‘the ’296 patent’’); authorize the Coast Guard to approve Director, Bureau of Safety and Environmental Enforcement. U.S. Patent No. 8,452,379 (‘‘the ’379 plans and locations for all bridges and patent’’); U.S. Patent No. 7,688,940 (‘‘the causeways that go over navigable waters [FR Doc. 2018–23709 Filed 10–29–18; 8:45 am] ’940 patent’’); U.S. Patent No. 7,986,765 of the United States. BILLING CODE 4310–VH–P (‘‘the ’765 patent’’); and U.S. Patent No. Forms: None. 7,123,684 (‘‘the ’684 patent’’). The Respondents: Public and private complaint further alleges that an owners of bridges over navigable waters INTERNATIONAL TRADE industry in the United States exists as of the United States. COMMISSION required by section 337. The Notice of Frequency: On occasion. Investigation named FUJIFILM [Inv. No. 337–TA–1063] Hour Burden Estimate: The estimated Corporation of Tokyo, Japan; FUJIFILM burden has increased from 12,354 hours Certain X-Ray Breast Imaging Devices Medical Systems USA, Inc. of Stamford, to 17,607 hours a year due to the and Components Thereof; Notice of a Connecticut; and FUJIFILM Techno increase in the annual number of Commission Determination To Review Products Co., Ltd. of Hanamaki-Shi respondents. the Final Initial Determination In-Part; Iwate, Japan (collectively, ‘‘Fujifilm’’) as Authority: The Paperwork Reduction Act Extension of the Target Date respondents. The Office of Unfair of 1995; 44 U.S.C. Chapter 35, as amended. Import Investigations (‘‘OUII’’) was Dated: October 25, 2018. AGENCY: U.S. International Trade named as a party. On January 18, 2018, Commission. James D. Roppel, the ’765 patent was terminated in its Acting Chief, U.S. Coast Guard, Office of ACTION: Notice. entirety from the investigation. See Information Management. Order No. 18 (Jan. 18, 2018) SUMMARY: Notice is hereby given that (unreviewed). [FR Doc. 2018–23638 Filed 10–29–18; 8:45 am] the U.S. International Trade On July 26, 2018, the ALJ issued the BILLING CODE 9110–04–P Commission has determined to review final ID and found a violation of section the final initial determination (‘‘ID’’) in- 337 has occurred. On August 8, 2018, part and extend the target date for Fujifilm and OUII each filed petitions DEPARTMENT OF THE INTERIOR completion of the investigation until for review of the final ID. On August 16, January 25, 2019. 2018, OUII and Hologic filed responses Bureau of Safety and Environmental FOR FURTHER INFORMATION CONTACT: to the petitions for review. Enforcement Amanda Pitcher Fisherow, Esq., Office Having examined the record of this [19XE8370SD//EEGG600000// of the General Counsel, U.S. investigation, including the ALJ’s final ED1OS0000.JR0000] International Trade Commission, 500 E ID, the petitions for review, and the Street SW, Washington, DC 20436, responses thereto, the Commission has Notice of Public Meeting telephone (202) 205–2737. Copies of determined to review the final ID in non-confidential documents filed in part. Specifically, the Commission has AGENCY: Bureau of Safety and connection with this investigation are or determined to review the ID’s findings Environmental Enforcement (BSEE), will be available for inspection during on (1) in rem jurisdiction and Interior. official business hours (8:45 a.m. to 5:15 importation; (2) all findings concerning ACTION: Notice of public meeting. p.m.) in the Office of the Secretary, U.S. infringement; (3) claim construction of SUMMARY: The Bureau of Safety and International Trade Commission, 500 E the ‘‘dose’’ limitations of the ’379 and Environmental Enforcement (BSEE) is Street SW, Washington, DC 20436, ’296 patents; (3) claim construction of hosting a public meeting to discuss telephone (202) 205–2000. General the limitations including terms of advancement of a low-emission spray information concerning the Commission degree (i.e., similar, substantially less, combustion unit for responding to oil may also be obtained by accessing its much less, and substantially higher) in spills. internet server at https://www.usitc.gov. the ’379 and ’296 patents; (4) the The public record for this investigation ‘‘control’’/‘‘motion control’’ and DATES: This public meeting will be held may be viewed on the Commission’s ‘‘processor’’ limitations of the ’379 and on December 10, 2018 from 9 to 11 a.m. electronic docket (EDIS) at https:// ’296 patents; (5) the technical prong of ADDRESSES: The meeting will be held in edis.usitc.gov. Hearing-impaired domestic industry for the ’379 and ’296 Room 121 at 1201 Elmwood Park Blvd., persons are advised that information on patents; (6) claim construction of the New Orleans, LA 70123. this matter can be obtained by ‘‘control’’ limitations of the ’940 patent;

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(7) anticipation by the Kopans 2000 In connection with the final investigation, interested government Army Report for the ’379 and ’296 disposition of this investigation, the agencies, and any other interested patents; (8) anticipation by MGH/GE Commission may (1) issue an order that parties are encouraged to file written Prototype #2 for the ’379 and ’296 could result in the exclusion of the submissions on the issues of remedy, patents; (9) obviousness based on the subject articles from entry into the the public interest, and bonding. Such publicly available MGH/GE References United States, and/or (2) issue one or submissions should address the related to the MGH/GE Prototypes for more cease and desist orders that could recommended determination by the ALJ the ’379 and ’296 patents; (10) result in the respondents being required on public interest, remedy, and anticipation by GE Senographe 2000D to cease and desist from engaging in bonding. Complainant and the OUII are System and/or Manual for the ’940 unfair acts in the importation and sale requested to submit proposed remedial patent; (11) obviousness based on GE of such articles. Accordingly, the orders for the Commission’s Senographe 2000D System and/or Commission is interested in receiving consideration. Complainant is also Manual with Dornheim for the ’940 written submissions that address the requested to state the date that the patent; (12) obviousness based on form of remedy, if any, that should be subject patents expire and the HTSUS Niklason article, the GE Senographe ordered. If a party seeks exclusion of an numbers under which the accused DMR System and Dornheim for the ’940 article from entry into the United States products are imported. Complainant is patent; and (13) indefiniteness under 35 for purposes other than entry for further requested to supply the names of U.S.C. 112 for the ’940 patent. consumption, the party should so known importers of the Respondents’ In connection with its review, the indicate and provide information products at issue in this investigation. Commission is interested in responses establishing that activities involving Also specifically, with respect to the to the following questions: other types of entry either are adversely public interest, the Commission 1. Was the argument that ‘‘conventional affecting it or likely to do so. For requests briefing on the following issue: mammogram,’’ as used in the ’379 and ’296 background, see Certain Devices for Please discuss whether the accused patents, should be construed to include Connecting Computers via Telephone Fujifilm products have been proven to be diagnostic images waived? See, e.g., OUII Lines, Inv. No. 337–TA–360, USITC more effective in screening for breast cancer Petition for Review at 9–12; Complainant’s Pub. No. 2843 (December 1994) than comparable systems available in the Resp. to OUII Petition at 2–3. (Commission Opinion). United States (e.g., systems from Hologic, 2. Does the claimed ‘‘dose’’ for a If the Commission contemplates some Siemens, or GE). Please include evidence to ‘‘conventional mammogram,’’ as used in the form of remedy, it must consider the support your position. ’379 and ’296 patents, meet the effects of that remedy upon the public The written submissions and indefiniteness standard set forth in Nautilus, Inc. v. Biosig Instruments, Inc., 134 S. Ct. interest. The factors the Commission proposed remedial orders must be filed 2120 (2014). The Commission is most will consider include the effect that an no later than close of business on interested in a discussion of the relevant exclusion order and/or cease and desist November 5, 2018. Reply submissions Federal Circuit precedent. orders would have on (1) the public must be filed no later than the close of 3. To what extent are the ID’s findings on health and welfare, (2) competitive business on November 13, 2018. whether the ‘‘dose’’ for a conventional conditions in the U.S. economy, (3) U.S. Opening submissions are limited to 75 mammogram has changed over time production of articles that are like or pages. Reply submissions are limited to necessary in establishing whether the ‘‘dose’’ directly competitive with those that are 50 pages. No further submissions on any for conventional mammogram is definite/ indefinite? See ID at 60–61. subject to investigation, and (4) U.S. of these issues will be permitted unless 4. Please discuss whether the terms of consumers. The Commission is otherwise ordered by the Commission. degree, as used in the asserted claims of ’379 therefore interested in receiving written Persons filing written submissions and ’296 patents, are indefinite. The submissions that address the must file the original document Commission is interested in evidence that aforementioned public interest factors electronically on or before the deadlines would provide an understanding of the terms in the context of this investigation. stated above and submit eight true paper to a person of ordinary skill in the art and If the Commission orders some form copies to the Office of the Secretary by the relevant case law. of remedy, the U.S. Trade noon the next day pursuant to section 5. The asserted claims of the ’379 and ’296 Representative, as delegated by the patents require a comparison of different x- 210.4(f) Of the Commission’s Rules of ray doses and in particular, to a dose used President, has 60 days to approve or Practice and Procedure (19 CFR for a conventional mammogram. Does the disapprove the Commission’s action. 2.10.4(f)). Submissions should refer to specification, claims, prosecution history, or See Presidential Memorandum of July the investigation number (‘‘Inv. No. extrinsic record shed light on whether the 21, 2005. 70 FR 43251 (July 26, 2005). 337–TA–1063’’) in a prominent place on comparison is made to a conventional two- During this period, the subject articles the cover page and/or the first page. (See dimensional system or whether the would be entitled to enter the United Handbook for Electronic Filing comparison is made to the two-dimensional States under bond, in an amount Procedures, http://www.usitc.gov/ mode on a device that performs both two- determined by the Commission and secretary/fed_reg_notices/rules/ dimensional and three-dimensional imaging? _ _ _ See, e.g., Fujifilm Petition for Review at 17. prescribed by the Secretary of the handbook on electronic filing.pdf). 6. Would claims 1, 2, and 22 of the ’940 Treasury. The Commission is therefore Persons with questions regarding filing patent be anticipated by the GE Senographe interested in receiving submissions should contact the Secretary (202–205– 2000D System and/or Manual if the concerning the amount of the bond that 2000). Commission were to find that the claims should be imposed if a remedy is Any person desiring to submit a allow for the anti-scatter grid to be ordered. document to the Commission in completely removed? See, e.g., Fujifilm The Commission has also determined confidence must request confidential Petition for Review at 55–59. to extend the target date for completion treatment. All such requests should be The parties are requested to brief only of this investigation until January 25, directed to the Secretary to the the discrete issues above, with reference 2019. Commission and must include a full to the applicable law and evidentiary Written Submissions: The parties to statement of the reasons why the record. The parties are not to brief other the investigation are requested to file Commission should grant such issues on review, which are adequately written submissions on the issues treatment. See 19 CFR 201.6. Documents presented in the parties’ existing filings. identified in this notice. Parties to the for which confidential treatment by the

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Commission is properly sought will be DATES: Registered bulk manufacturers of 2018, Cambrex High Point, Inc., 4180 treated accordingly. All information, the affected basic classes, and Mendenhall Oaks Parkway, High Point, including confidential business applicants therefore, may file written North Carolina 27265–8017 applied to information and documents for which comments on or objections to the be registered as an importer of the confidential treatment is properly issuance of the proposed registration on following basic class of controlled sought, submitted to the Commission for or before November 29, 2018. Such substance: purposes of this Investigation may be persons may also file a written request disclosed to and used: (i) By the for a hearing on the application on or Controlled Drug code Schedule Commission, its employees and Offices, before November 29, 2018. substance and contract personnel (a) for ADDRESSES: Written comments should Poppy Straw Con- 9670 II developing or maintaining the records be sent to: Drug Enforcement centrate. of this or a related proceeding, or (b) in Administration, Attention: DEA Federal internal investigations, audits, reviews, Register Representative/DPW, 8701 The company plans to import the and evaluations relating to the Morrissette Drive, Springfield, Virginia listed controlled substance for clinical programs, personnel, and operations of 22152. All requests for hearing must be trial narcotic material for bulk the Commission including under 5 sent to: Drug Enforcement manufacture. U.S.C. Appendix 3; or (ii) by U.S. Administration, Attn: Administrator, Dated: October 22, 2018. government employees and contract 8701 Morrissette Drive, Springfield, personnel,1 solely for cybersecurity Virginia 22152. All requests for hearing John J. Martin, purposes. All nonconfidential written should also be sent to: (1) Drug Assistant Administrator. submissions will be available for public Enforcement Administration, Attn: [FR Doc. 2018–23699 Filed 10–29–18; 8:45 am] inspection at the Office of the Secretary Hearing Clerk/OALJ, 8701 Morrissette BILLING CODE 4410–09–P and on EDIS. Drive, Springfield, Virginia 22152; and The authority for the Commission’s (2) Drug Enforcement Administration, determination is contained in section Attn: DEA Federal Register DEPARTMENT OF JUSTICE 337 of the Tariff Act of 1930, as Representative/DPW, 8701 Morrissette Drug Enforcement Administration amended (19 U.S.C. 1337), and in part Drive, Springfield, Virginia 22152. 210 of the Commission’s Rules of SUPPLEMENTARY INFORMATION: [Docket No. DEA–392] Practice and Procedure (19 CFR part The Attorney General has delegated 210). his authority under the Controlled Importer of Controlled Substances By order of the Commission. Substances Act to the Administrator of Registration Issued: October 24, 2018. the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to ACTION: Notice of registration. Jessica Mullan, exercise all necessary functions with SUMMARY: The registrant listed below Attorney Advisor. respect to the promulgation and has applied for and been granted [FR Doc. 2018–23618 Filed 10–29–18; 8:45 am] implementation of 21 CFR part 1301, registration by the Drug Enforcement BILLING CODE 7020–02–P incident to the registration of Administration (DEA) as an importer of manufacturers, distributors, dispensers, schedule I or schedule II controlled importers, and exporters of controlled substances. DEPARTMENT OF JUSTICE substances (other than final orders in connection with suspension, denial, or SUPPLEMENTARY INFORMATION: Drug Enforcement Administration revocation of registration) has been The company listed below applied to redelegated to the Assistant be registered as an importer of various [Docket No. DEA–392] Administrator of the DEA Diversion basic classes of controlled substances. Control Division (‘‘Assistant Information on the previously published Importer of Controlled Substances Administrator’’) pursuant to section 7 of notice is listed in the table below. No Application: Cambrex High Point, Inc. 28 CFR part 0, appendix to subpart R. comments or objections were submitted In accordance with 21 CFR and no requests for hearing were ACTION: Notice of application. 1301.34(a), this is notice that on July 16, submitted for this notice.

Company FR Docket Published

Cody Laboratories, Inc...... 83 FR 37524 August 1, 2018.

The DEA has considered the factors in treaties, conventions, or protocols in local laws, and reviewing the company’s 21 U.S.C. 823, 952(a) and 958(a) and effect on May 1, 1971. The DEA background and history. determined that the registration of the investigated the company’s maintenance Therefore, pursuant to 21 U.S.C. listed registrant to import the applicable of effective controls against diversion by 952(a) and 958(a), and in accordance basic classes of schedule I or II inspecting and testing the company’s with 21 CFR 1301.34, the DEA has controlled substances is consistent with physical security systems, verifying the granted a registration as an importer for the public interest and with United company’s compliance with state and schedule II controlled substances to the States obligations under international above listed company.

1 All contract personnel will sign appropriate nondisclosure agreements.

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Dated: October 11, 2018. DEPARTMENT OF JUSTICE Dated: October 22, 2018. John J. Martin, John J. Martin, Assistant Administrator. Drug Enforcement Administration Assistant Administrator. [FR Doc. 2018–23684 Filed 10–29–18; 8:45 am] [FR Doc. 2018–23696 Filed 10–29–18; 8:45 am] BILLING CODE 4410–09–P [Docket No. DEA–392] BILLING CODE 4410–09–P Bulk Manufacturer of Controlled DEPARTMENT OF JUSTICE Substances Application: Insys DEPARTMENT OF JUSTICE Manufacturing, LLC Drug Enforcement Administration Drug Enforcement Administration ACTION: Notice of application. [Docket No. DEA–392] [Docket No. DEA–392] DATES: Registered bulk manufacturers of Importer of Controlled Substances Bulk Manufacturer of Controlled the affected basic classes, and Application: United States Substances Registration applicants therefore, may file written Pharmacopeial Convention comments on or objections to the ACTION: Notice of registration. issuance of the proposed registration on ACTION: Notice of application. or before December 31, 2018. SUMMARY: Registrants listed below have DATES: Registered bulk manufacturers of applied for and been granted ADDRESSES: Written comments should the affected basic classes, and registration by the Drug Enforcement be sent to: Drug Enforcement applicants therefore, may file written Administration (DEA) as bulk Administration, Attention: DEA Federal comments on or objections to the manufacturers of various classes of Register Representative/DPW, 8701 issuance of the proposed registration on schedule I and II controlled substances. Morrissette Drive, Springfield, Virginia or before November 29, 2018. Such SUPPLEMENTARY INFORMATION: The 22152. persons may also file a written request for a hearing on the application on or companies listed below applied to be SUPPLEMENTARY INFORMATION: The before November 29, 2018. registered as bulk manufacturers of Attorney General has delegated his various basic classes of controlled authority under the Controlled ADDRESSES: Written comments should substances. Information on previously Substances Act to the Administrator of be sent to: Drug Enforcement published notices is listed in the table the Drug Enforcement Administration Administration, Attention: DEA Federal below. No comments or objections were (DEA), 28 CFR 0.100(b). Authority to Register Representative/DPW, 8701 submitted for these notices. exercise all necessary functions with Morrissette Drive, Springfield, Virginia respect to the promulgation and 22152. All requests for hearing must be Company FR docket Published implementation of 21 CFR part 1301, sent to: Drug Enforcement incident to the registration of Administration, Attn: Administrator, Johnson Matthey 83 FR June 13, 8701 Morrissette Drive, Springfield, Pharmaceutical 27632. 2018. manufacturers, distributors, dispensers, Materials Inc. importers, and exporters of controlled Virginia 22152. All requests for hearing Alcami Wisconsin 83 FR June 13, substances (other than final orders in should also be sent to: (1) Drug Corporation. 27628. 2018. connection with suspension, denial, or Enforcement Administration, Attn: revocation of registration) has been Hearing Clerk/OALJ, 8701 Morrissette The DEA has considered the factors in redelegated to the Assistant Drive, Springfield, Virginia 22152; and 21 U.S.C. 823(a) and determined that Administrator of the DEA Diversion (2) Drug Enforcement Administration, the registration of these registrants to Control Division (‘‘Assistant Attn: DEA Federal Register manufacture the applicable basic classes Administrator’’) pursuant to section 7 of Representative/DPW, 8701 Morrissette of controlled substances is consistent 28 CFR part 0, appendix to subpart R. Drive, Springfield, Virginia 22152. SUPPLEMENTARY INFORMATION: with the public interest and with United In accordance with 21 CFR The Attorney General has delegated States obligations under international 1301.33(a), this is notice that on August his authority under the Controlled treaties, conventions, or protocols in 22, 2018, Insys Manufacturing, LLC, Substances Act to the Administrator of effect on May 1, 1971. The DEA 2700 Oakmont Drive, Round Rock, the Drug Enforcement Administration investigated each of the company’s Texas 78665–1019 applied to be (DEA), 28 CFR 0.100(b). Authority to maintenance of effective controls registered as a bulk manufacturer of the exercise all necessary functions with against diversion by inspecting and following basic classes of controlled respect to the promulgation and testing each company’s physical substances: security systems, verifying each implementation of 21 CFR part 1301, company’s compliance with state and Controlled sub- incident to the registration of local laws, and reviewing each stance Drug code Schedule manufacturers, distributors, dispensers, company’s background and history. importers, and exporters of controlled Therefore, pursuant to 21 U.S.C. Marihuana ...... 7360 I substances (other than final orders in 823(a), and in accordance with 21 CFR Tetrahydrocann- 7370 I connection with suspension, denial, or abinols. 1301.33, the DEA has granted a revocation of registration) has been registration as a bulk manufacturer to redelegated to the Assistant the above listed companies. The company plans to manufacture Administrator of the DEA Diversion bulk synthetic active pharmaceutical Control Division (‘‘Assistant Dated: October 22, 2018. ingredients (APIs) for product Administrator’’) pursuant to section 7 of John J. Martin, development and distribution to its 28 CFR part 0, appendix to subpart R. Assistant Administrator. customers. No other activity for these In accordance with 21 CFR [FR Doc. 2018–23698 Filed 10–29–18; 8:45 am] drug codes are authorized for this 1301.34(a), this is notice that on August BILLING CODE 4410–09–P registration. 17, 2018, United States Pharmacopeial

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Convention, 12601 Twinbrook Parkway, respect to the promulgation and Administration, Attention: DEA Federal Rockville, Maryland 20852–1717, implementation of 21 CFR part 1301, Register Representative/DPW, 8701 applied to be registered as an importer incident to the registration of Morrissette Drive, Springfield, Virginia of the following basic class of the manufacturers, distributors, dispensers, 22152. All requests for hearing must be controlled substance: importers, and exporters of controlled sent to: Drug Enforcement substances (other than final orders in Administration, Attn: Administrator, Controlled connection with suspension, denial, or substance Drug code Schedule 8701 Morrissette Drive, Springfield, revocation of registration) has been Virginia 22152. All requests for hearing redelegated to the Assistant Oxymorphone ...... 9652 II should also be sent to: (1) Drug Administrator of the DEA Diversion Enforcement Administration, Attn: Control Division (‘‘Assistant The company plans to import the bulk Hearing Clerk/OALJ, 8701 Morrissette Administrator’’) pursuant to section 7 of controlled substance for distribution of 28 CFR part 0, appendix to subpart R. Drive, Springfield, Virginia 22152; and analytical reference standards to its In accordance with 21 CFR (2) Drug Enforcement Administration, customers for research and analytical 1301.34(a), this is notice that on August Attn: DEA Federal Register purposes. 30, 2018, Sharp (Bethlehem), LLC, 2400 Representative/DPW, 8701 Morrissette Dated: October 22, 2018. Baglyos Circle, Bethlehem, Drive, Springfield, Virginia 22152. John J. Martin, Pennsylvania 18020, applied to be SUPPLEMENTARY INFORMATION: The Assistant Administrator. registered as an importer of the Attorney General has delegated his [FR Doc. 2018–23701 Filed 10–29–18; 8:45 am] following basic class of controlled authority under the Controlled substances: BILLING CODE 4410–09–P Substances Act to the Administrator of Controlled the Drug Enforcement Administration Drug code Schedule (DEA), 28 CFR 0.100(b). Authority to DEPARTMENT OF JUSTICE substance exercise all necessary functions with Gamma Hydrox- 2010 I Drug Enforcement Administration respect to the promulgation and ybutyric Acid. implementation of 21 CFR part 1301, [Docket No. DEA–392] incident to the registration of The company plans to import dosage manufacturers, distributors, dispensers, Importer of Controlled Substances forms of the listed controlled substances importers, and exporters of controlled Application: Sharp (Bethlehem), LLC to conduct clinical trials. Approval of permit applications will substances (other than final orders in ACTION: Notice of application. occur only when the registrant’s activity connection with suspension, denial, or is consistent with what is authorized revocation of registration) has been DATES: Registered bulk manufacturers of under to 21 U.S.C. 952 (a)(2). redelegated to the Assistant the affected basic classes, and Authorization will not extend to the Administrator of the DEA Diversion applicants therefore, may file written import of FDA approved or non- Control Division (‘‘Assistant comments on or objections to the approved finished dosage forms for Administrator’’) pursuant to section 7 of issuance of the proposed registration on commercial sale. 28 CFR part 0, appendix to subpart R. or before November 29, 2018. Such Dated: October 22, 2018. In accordance with 21 CFR persons may also file a written request John J. Martin, 1301.34(a), this is notice that on August for a hearing on the application on or 17, 2018, Fisher Clinical Services Inc., before November 29, 2018. Assistant Administrator. [FR Doc. 2018–23705 Filed 10–29–18; 8:45 am] 7554 Schantz Road, Allentown, ADDRESSES: Written comments should BILLING CODE 4410–09–P Pennsylvania 18106, applied to be be sent to: Drug Enforcement registered as an importer of the Administration, Attention: DEA Federal following basic classes of controlled Register Representative/DPW, 8701 DEPARTMENT OF JUSTICE substances: Morrissette Drive, Springfield, Virginia 22152. All requests for hearing must be Drug Enforcement Administration Controlled sent to: Drug Enforcement substance Drug code Schedule Administration, Attn: Administrator, [Docket No. DEA–392] 8701 Morrissette Drive, Springfield, Importer of Controlled Substances Psilocybin ...... 7437 I Virginia 22152. All requests for hearing Application: Fisher Clinical Services, Methylphenidate 1724 II should also be sent to: (1) Drug Inc. Levorphanol ...... 9220 II Enforcement Administration, Attn: Noroxymorphon- 9668 II e. Hearing Clerk/OALJ, 8701 Morrissette ACTION: Notice of application. Drive, Springfield, Virginia 22152; and Tapentadol ...... 9780 II (2) Drug Enforcement Administration, DATES: Registered bulk manufacturers of Attn: DEA Federal Register the affected basic classes, and The company plans to import the Representative/DPW, 8701 Morrissette applicants therefore, may file written listed controlled substances for clinical Drive, Springfield, Virginia 22152. comments on or objections to the trials. issuance of the proposed registration on SUPPLEMENTARY INFORMATION: Dated: October 22, 2018. The Attorney General has delegated or before November 29, 2018. Such John J. Martin, his authority under the Controlled persons may also file a written request Substances Act to the Administrator of for a hearing on the application on or Assistant Administrator. the Drug Enforcement Administration before November 29, 2018. [FR Doc. 2018–23702 Filed 10–29–18; 8:45 am] (DEA), 28 CFR 0.100(b). Authority to ADDRESSES: Written comments should BILLING CODE 4410–09–P exercise all necessary functions with be sent to: Drug Enforcement

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DEPARTMENT OF JUSTICE ADDRESSES: Written comments should manufacturers, distributors, dispensers, be sent to: Drug Enforcement importers, and exporters of controlled Drug Enforcement Administration Administration, Attention: DEA Federal substances (other than final orders in connection with suspension, denial, or [Docket No. DEA–392] Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia revocation of registration) has been Bulk Manufacturer of Controlled 22152. delegated to the Assistant Administrator Substances Application: Sigma Aldrich of the DEA Diversion Control Division Research SUPPLEMENTARY INFORMATION: The (‘‘Assistant Administrator’’) pursuant to Attorney General has delegated his section 7 of 28 CFR part 0, appendix to ACTION: Notice of application. authority under the Controlled subpart R. Substances Act to the Administrator of In accordance with 21 CFR DATES: Registered bulk manufacturers of the Drug Enforcement Administration 1301.33(a), this is notice that on June the affected basic classes, and (DEA), 28 CFR 0.100(b). Authority to 14, 2018, Sigma Aldrich Research, 1–3 applicants therefore, may file written exercise all necessary functions with Strathmore Road, Natick, Massachusetts comments on or objections to the respect to the promulgation and 01760–2447 applied to be registered as issuance of the proposed registration on implementation of 21 CFR part 1301, a bulk manufacturer of the following or before December 31, 2018. incident to the registration of basic classes of controlled substances:

Controlled substance Drug code Schedule

Cathinone ...... 1235 I Mephedrone (4-Methyl-N-methylcathinone) ...... 1248 I Lysergic acid diethylamide ...... 7315 I 3,4-Methylenedioxymethamphetamine ...... 7405 I Dimethyltryptamine ...... 7435 I 5-Methoxy-N,N-diisopropyltryptamine ...... 7439 I MDPV (3,4-Methylenedioxypyrovalerone) ...... 7535 I Heroin ...... 9200 I Normorphine ...... 9313 I Norlevorphanol ...... 9634 I Amphetamine ...... 1100 II Nabilone ...... 7379 II Cocaine ...... 9041 II Codeine ...... 9050 II Ecgonine ...... 9180 II Levorphanol ...... 9220 II Meperidine ...... 9230 II Methadone ...... 9250 II Morphine ...... 9300 II Thebaine ...... 9333 II Levo-alphacetylmethadol ...... 9648 II Remifentanil ...... 9739 II Sufentanil ...... 9740 II Carfentanil ...... 9743 II Fentanyl ...... 9801 II

The company plans to manufacture issuance of the proposed registration on SUPPLEMENTARY INFORMATION: reference standards. or before November 29, 2018. Such The Attorney General has delegated Dated: October 11, 2018. persons may also file a written request his authority under the Controlled Substances Act to the Administrator of John J. Martin, for a hearing on the application on or before November 29, 2018. the Drug Enforcement Administration Assistant Administrator. (DEA), 28 CFR 0.100(b). Authority to [FR Doc. 2018–23695 Filed 10–29–18; 8:45 am] ADDRESSES: Written comments should exercise all necessary functions with BILLING CODE 4410–09–P be sent to: Drug Enforcement respect to the promulgation and Administration, Attention: DEA Federal implementation of 21 CFR part 1301, Register Representative/DPW, 8701 incident to the registration of DEPARTMENT OF JUSTICE Morrissette Drive, Springfield, Virginia manufacturers, distributors, dispensers, 22152. All requests for hearing must be importers, and exporters of controlled Drug Enforcement Administration sent to: Drug Enforcement substances (other than final orders in Administration, Attn: Administrator, [Docket No. DEA–392] connection with suspension, denial, or 8701 Morrissette Drive, Springfield, revocation of registration) has been Importer of Controlled Substances Virginia 22152. All requests for hearing redelegated to the Assistant Application: Catalent CTS, LLC should also be sent to: (1) Drug Administrator of the DEA Diversion Enforcement Administration, Attn: Control Division (‘‘Assistant ACTION: Notice of application. Hearing Clerk/OALJ, 8701 Morrissette Administrator’’) pursuant to section 7 of Drive, Springfield, Virginia 22152; and 28 CFR part 0, appendix to subpart R. DATES: Registered bulk manufacturers of (2) Drug Enforcement Administration, In accordance with 21 CFR the affected basic classes, and Attn: DEA Federal Register 1301.34(a), this is notice that on July 17, applicants therefore, may file written Representative/DPW, 8701 Morrissette 2018, Catalent CTS, LLC, 10245 comments on or objections to the Drive, Springfield, Virginia 22152. Hickman Mills Drive, Kansas City,

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Missouri 64137–1418 applied to be dispense controlled substances in Based on the DI’s Declaration, the registered as an importer of the schedules II through V as a practitioner. Government’s written representations, following basic classes of controlled Id. The OSC alleges that this registration and my review of the record, I find that substances: expires on December 31, 2018. Id. the Government personally served the The substantive ground for the OSC on Registrant on February 16, 2018. Drug Controlled substance code Schedule proceeding, as alleged in the OSC, is I also find that more than 30 days have that Registrant is ‘‘without authority to now passed since the date the Gamma Hydroxybutyric 2010 I handle controlled substances in New Government served the OSC. Further, Acid. based on the Government’s written Marihuana Extract ...... 7350 I Hampshire, the state in which [he is] Marihuana ...... 7360 I registered with the DEA.’’ Id. representations, I find that neither Tetrahydrocannabinols ..... 7370 I Specifically, the OSC alleges that the Registrant, nor anyone purporting to State of New Hampshire Board of represent him, requested a hearing, The company plans to import finished Medicine (hereinafter, Board) issued an submitted a written statement while dosage unit products containing gamma- Order of Emergency License Suspension waiving Registrant’s right to a hearing, hydroxybutryic acid and marihuana and Notice of Hearing on September 25, or submitted a corrective action plan. extracts for clinical trial studies. These 2017. Id. at 1–2. On the following day, Accordingly, I find that Registrant has marihuana extracts compounds are September 26, 2017, Registrant entered waived his right to a hearing and his listed under drug code 7350. No other into a written agreement ‘‘not to practice right to submit a written statement and activity for these drug codes is medicine [including the writing of] corrective action plan. 21 CFR authorized for this registration. prescriptions . . . until further order of 1301.43(d) and 21 U.S.C. 824(c)(2)(C). I, Approval of permit applications will the Board.’’ Id. at 2. therefore, issue this Decision and Order occur only when the registrant’s The OSC notifies Registrant of his based on the record submitted by the business activity is consistent with what right to request a hearing on the Government, which constitutes the is authorized under 21 U.S.C. 952(a) (2). allegations or to submit a written entire record before me. 21 CFR Authorization will not extend to the statement while waiving his right to a 1301.43(e). import of FDA-approved or non- hearing, the procedures for electing each Findings of Fact approved finished dosage forms for option, and the consequences for failing commercial sale. to elect either option. Id. (citing 21 CFR Registrant’s DEA Registration Dated: October 19, 2018. 1301.43). The OSC also notifies Registrant is the holder of DEA John J. Martin, Registrant of the opportunity to submit Certificate of Registration No. Assistant Administrator. a corrective action plan. OSC, at 2–3 BK7282940 at the registered address of 1 [FR Doc. 2018–23686 Filed 10–29–18; 8:45 am] (citing 21 U.S.C. 824(c)(2)(C)). 93 ⁄2 Walnut Hill Road, Derry, New Hampshire 03038. GX 1 (Certification of BILLING CODE 4410–09–P Adequacy of Service Registration), at 1. Pursuant to this In a Declaration dated April 27, 2018, registration, Registrant is authorized to DEPARTMENT OF JUSTICE a Diversion Investigator (hereinafter, dispense controlled substances in DI), who describes herself as being schedules II through V as a practitioner. Drug Enforcement Administration assigned to the DEA Boston Field Id. Registrant’s registration expires on Division-Manchester (New Hampshire) December 31, 2018. Id. Eric Lee Knight, M.D.; Decision and District Office, states that after two The Status of Registrant’s State License Order unsuccessful attempts at serving the In this case, the Board issued an On February 6, 2018, the Acting OSC on Registrant, she and two Task Order of Emergency License Suspension Assistant Administrator, Diversion Force Officers traveled to the residence and Notice of Hearing on September 25, Control Division, Drug Enforcement of Registrant on February 16, 2018, and 2017. The Board’s Order suspended Administration (hereinafter, DEA or ‘‘[a]fter displaying our credentials to Dr. Registrant’s New Hampshire medical Government), issued an Order to Show Knight, I presented the original copy of license until further order of the Board. Cause to Eric Lee Knight, M.D. the . . . [OSC] to Dr. Knight.’’ GX 3 (Order of Emergency License (hereinafter, Registrant), of Derry, New (Government Exhibit (hereinafter, GX) 8 Suspension and Notice of Hearing), at Hampshire. Order to Show Cause at 2–3 (Declaration of DEA Diversion 13. On October 9, 2017, the Board (hereinafter, OSC), at 1. The OSC Investigator). accepted Registrant’s agreement ‘‘not to proposes the revocation of Registrant’s In its Request for Final Agency Action practice medicine . . . [including the Certificate of Registration on the ground dated May 3, 2018, the Government writing of] prescriptions . . . until that he does ‘‘not have authority to represents that ‘‘[m]ore than 30-days further order of the Board.’’ GX 4 handle controlled substances in the have passed since Registrant received (Preliminary Agreement Not to State of New Hampshire, the state in the . . . [OSC]; however, Registrant has not submitted to DEA a request for Practice), at 1. which . . . [he is] registered with the According to New Hampshire’s online DEA.’’ Id. (citing 21 U.S.C. 823(f) and hearing.’’ Request for Final Agency Action, at 2. In its Request for Final records, of which I take official notice, 824(a)(3)). Registrant’s license to practice medicine Regarding jurisdiction, the OSC Agency Action—Addendum dated is still suspended.2 New Hampshire alleges that Registrant holds DEA September 26, 2018, the Government represents that Registrant has not Certificate of Registration No. 2 Under the Administrative Procedure Act, an BK7282940 at the registered address of ‘‘corresponded in writing or otherwise agency ‘‘may take official notice of facts at any stage 93 1⁄2 Walnut Hill Road, Derry, New with regard to his position on a hearing in a proceeding—even in the final decision.’’ Hampshire 03038.1 OSC, at 1. This before DEA.’’ Request for Final Agency United States Department of Justice, Attorney Action—Addendum, at 2. The General’s Manual on the Administrative Procedure registration authorizes Registrant to Act 80 (1947) (Wm. W. Gaunt & Sons, Inc., Reprint Government requests the issuance of a 1979). Pursuant to 5 U.S.C. 556(e), ‘‘[w]hen an 1 The OSC erroneously lists the number of Final Order revoking Registrant’s DEA agency decision rests on official notice of a material Registrant’s address on Walnut Hill Road as 92 1⁄2. registration. Id. at 4. fact not appearing in the evidence in the record, a

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Online Licensing, http:// is no longer authorized to dispense Dated: October 18, 2018. www.nhlicenses.nh.gov (last visited controlled substances under the laws of Uttam Dhillon, October 18, 2018). the State in which he practices. See, Acting Administrator. Accordingly, I find that Registrant e.g., Hooper, supra, 76 FR at 71,371–72; [FR Doc. 2018–23708 Filed 10–29–18; 8:45 am] currently is not licensed to engage in the Sheran Arden Yeates, M.D., 71 FR BILLING CODE 4410–09–P practice of medicine in New Hampshire, 39,130, 39,131 (2006); Dominick A. the State in which he is registered with Ricci, M.D., 58 FR 51,104, 51,105 (1993); the DEA. Bobby Watts, M.D., 53 FR 11,919, 11,920 DEPARTMENT OF LABOR Discussion (1988); Blanton, supra, 43 FR at 27,617. Mine Safety and Health Administration Pursuant to 21 U.S.C. 824(a)(3), the In this case, according to the Board, Attorney General is authorized to the Registrant is alleged to have engaged Affirmative Decisions on Petitions for suspend or revoke a registration issued in numerous acts of professional Modification Granted in Whole or in under section 823 of the Controlled misconduct based upon, inter alia, Part Substances Act (hereinafter, CSA), inappropriate personal relationships ‘‘upon a finding that the registrant . . . with patients, as well as his issuance of AGENCY: Mine Safety and Health has had his State license or registration controlled substance prescriptions for Administration (MSHA), Labor. suspended . . . [or] revoked . . . by no legitimate medical purpose in ACTION: Notice. competent State authority and is no violation of New Hampshire law. GX 3, SUMMARY: The Federal Mine Safety and longer authorized by State law to engage at 3–9. As a result of Registrant’s alleged in the . . . dispensing of controlled Health Act of 1977 and the Code of misconduct, on September 25, 2017, the substances.’’ With respect to a Federal Regulations govern the Board issued its Order of Emergency practitioner, the DEA has also long held application, processing, and disposition that the possession of authority to License Suspension and Notice of of petitions for modification. This dispense controlled substances under Hearing. On September 26, 2017, Federal Register notice notifies the the laws of the State in which a Registrant entered into a Preliminary public that MSHA has investigated and practitioner engages in professional Agreement Not to Practice, whereby he issued a final decision on certain mine practice is a fundamental condition for agreed, inter alia, ‘‘not to practice operator petitions to modify a safety obtaining and maintaining a medicine . . . [including the writing of] standard. practitioner’s registration. See, e.g., prescriptions . . . until further order of ADDRESSES: Copies of the final decisions the Board.’’ GX 4, at 1. On October 9, James L. Hooper, M.D., 76 FR 71,371 are posted on MSHA’s website at (2011), pet. for rev. denied, 481 Fed. 2017, the Board accepted Registrant’s https://www.msha.gov/regulations/ Appx. 826 (4th Cir. 2012); Frederick Preliminary Agreement Not to Practice. rulemaking/petitions-modification. The Marsh Blanton, M.D., 43 FR 27,616, GX 4, at 3. Consequently, Registrant is public may inspect the petitions and 27,617 (1978). not currently authorized to handle This rule derives from the text of two final decisions during normal business controlled substances in the State of hours in MSHA’s Office of Standards, provisions of the CSA. First, Congress New Hampshire, the State in which he defined the term ‘‘practitioner’’ to mean Regulations, and Variances, 201 12th is registered with the Agency and, Street South, Suite 4E401, Arlington, ‘‘a physician . . . or other person therefore, he is not entitled to maintain licensed, registered, or otherwise Virginia 22202. All visitors are required his DEA registration. Hooper, supra, 76 permitted, by . . . the jurisdiction in to check in at the receptionist’s desk in FR at 71,371–72, Blanton, supra, 43 FR which he practices . . ., to distribute, Suite 4E401. dispense, . . . [or] administer . . . a at 27,617. Accordingly, I will order that FOR FURTHER INFORMATION CONTACT: controlled substance in the course of Registrant’s registration be revoked, that Barbara Barron at 202–693–9447 (voice), professional practice.’’ 21 U.S.C. any pending application for the renewal [email protected] (email), or 202– 802(21). Second, in setting the or modification of his registration be 693–9441 (fax). [These are not toll-free requirements for obtaining a denied, and that any pending numbers]. practitioner’s registration, Congress application by Registrant for a SUPPLEMENTARY INFORMATION: directed that ‘‘[t]he Attorney General registration in New Hampshire be shall register practitioners . . . if the denied. 21 U.S.C. 824(a)(3) and 823(f). I. Introduction applicant is authorized to dispense . . . Under section 101 of the Federal Mine Order controlled substances under the laws of Safety and Health Act of 1977, a mine the State in which he practices.’’ 21 Pursuant to 28 CFR 0.100(b) and the operator may petition and the Secretary U.S.C. 823(f). Because Congress has authority thus vested in me by 21 U.S.C. of Labor (Secretary) may modify the clearly mandated that a practitioner 824(a), I order that DEA Certificate of application of a mandatory safety possess State authority in order to be Registration No. BK7282940 issued to standard to that mine if the Secretary deemed a practitioner under the CSA, Eric Lee Knight, M.D., be, and it hereby determines that: (1) An alternative the DEA has held repeatedly that is, revoked. Pursuant to 28 CFR 0.100(b) method exists that will guarantee no revocation of a practitioner’s registration less protection for the miners affected and the authority thus vested in me by is the appropriate sanction whenever he than that provided by the standard; or 21 U.S.C. 823(f), I further order that any (2) the application of the standard will party is entitled, on timely request, to an pending application of Eric Lee Knight, result in a diminution of safety to the opportunity to show the contrary.’’ Accordingly, M.D., to renew or modify this affected miners. Registrant may dispute my finding by filing a registration, as well as any other properly supported motion for reconsideration MSHA bases the final decision on the within 20 calendar days of the date of this Order. pending application by him for petitioner’s statements, any comments Any such motion shall be filed with the Office of registration in the State of New and information submitted by interested the Administrator and a copy shall be served on the Hampshire, be, and it hereby is, denied. Government. In the event Registrant files a motion, persons, and a field investigation of the the Government shall have 20 calendar days to file This Order is effective November 29, conditions at the mine. In some a response. 2018. instances, MSHA may approve a

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petition for modification on the Mine: Freedom Mine, MSHA I.D. No. Harmonized System of Classification condition that the mine operator 32–00595, located in Mercer County, and Labelling of Chemicals (GHS) complies with other requirements noted North Dakota. Coordinating Group, plans to consider in the decision. Regulation Affected: 30 CFR the comments and information gathered 77.1607(u) (Loading and haulage at this public meeting when developing II. Granted Petitions for Modification equipment; operation). the U.S. Government positions for the On the basis of the findings of • Docket Number: M–2018–001–M. UNSCEGHS meeting. OSHA also will MSHA’s investigation, and as designee FR Notice: 83 FR 4929 (2/2/2018). give an update on the Regulatory of the Secretary, MSHA has granted or Petitioner: Martin Marietta Kansas Cooperation Council (RCC). partially granted the following petitions City, LLC, 1099 18th Street, Suite 2150, Also on Tuesday, November 13, 2018, for modification: Denver, Colorado 80202. the Department of Transportation • Docket Number: M–2016–033–C. Mines: Randolph Deep Mine, MSHA (DOT), Pipeline and Hazardous FR Notice: 81 FR 81811 (11/18/2016). I.D. No. 23–02308, located in Clay Materials Safety Administration Petitioner: Mach Mining LLC, P.O. County, Missouri; Stamper (PHMSA) will conduct a public meeting Box 300, Johnston City, Illinois 62951. Underground Mine, MSHA I.D, No. 23– (See Docket No. PHMSA–2018–0024 Mine: Mach No. 1 Mine, MSHA I.D. 02232 and Parkville Quarry, MSHA I.D. Notice No. 2018–11) to discuss No. 11–03141, located in Williamson No. 23–01883, located in Platte County, proposals in preparation for the 54th County, Illinois. Missouri. session of the United Nations Sub- Regulation Affected: 30 CFR 75.503 Regulation Affected: 30 CFR 49.6(a)(1) Committee of Experts on the Transport (Permissible electric face equipment; (Equipment and maintenance of Dangerous Goods (UNSCE TDG) to be maintenance) and 30 CFR 18.35(a)(5)(i) requirements). held November 26 through December 4, (Portable (trailing) cables and cords). • Docket Number: M–2018–002–M. 2018, in Geneva, Switzerland. During • Docket Number: M–2017–013–C. FR Notice: 83 FR 7780 (2/22/2018). this meeting, PHMSA is also requesting FR Notice: 82 FR 34700 (7/26/2017). Petitioner: Central Plains Cement comments relative to potential new Petitioner: Texas Westmoreland Coal Company, 1801 Wewatta Street, Suite work items that may be considered for Company, P.O. Box 915, Jewett, Texas 1000, Denver, Colorado 80202. inclusion in its international agenda. 75846. Mine: Sugar Creek Underground PHMSA will also provide an update on Mine: Jewett Mine, MSHA I.D. No. Mine, MSHA I.D. No. 23–02171, located recent actions to enhance transparency 41–03164, located in Leon County, in Jackson County, Missouri. and stakeholder interaction through Texas. Regulation Affected: 30 CFR 49.6(a)(1) improvements to the international Regulation Affected: 30 CFR 77.803 (Equipment and maintenance standards portion of its website. (Fail safe ground check circuits on high- requirements). DATES: Tuesday, November 13, 2018. voltage resistance grounded systems). Roslyn B. Fontaine, ADDRESSES: Both meetings will be held • Docket Number: M–2017–019–C. Deputy Director, Office of Standards, at the DOT Headquarters Conference FR Notice: 82 FR 49684 (10/26/2017). Regulations, and Variances. Center, West Building, Oklahoma City Petitioner: Marfork Coal Company, [FR Doc. 2018–23649 Filed 10–29–18; 8:45 am] Conference Room, 1200 New Jersey LLC, 500 Lee Street East, Suite 701 BILLING CODE 4520–43–P Avenue SE, Washington, DC 20590. (25301), Post Office Box 2548, Times and Locations: PHMSA public Charleston, West Virginia 25329. meeting: 9 a.m. to 12 p.m. EDT, Mine: Slip Ridge Cedar Grove Mine, DEPARTMENT OF LABOR Oklahoma City Conference Room, MSHA I.D. No. 46–09048, located in OSHA public meeting: 1 p.m. to 4 p.m. Raleigh County, West Virginia. Occupational Safety and Health EDT, Oklahoma City Conference Room Regulation Affected: 30 CFR 75.360 Administration Advanced Meeting Registration: DOT (Preshift examination at fixed intervals). [Docket No. OSHA–2016–0005] requests that attendees pre-register for • Docket Number: M–2017–021–C. these meetings by completing the form FR Notice: 82 FR 60045 (12/18/2017). Preparations for the 36th Session of at: https://www.surveymonkey.com/r/ Petitioner: Rosebud Mining Company, the UN Sub-Committee of Experts on XGN8J7X. 301 Market Street, Kittanning, the Globally Harmonized System of Attendees may use the same form to Pennsylvania 16201. Classification and Labelling of pre-register for both meetings. Failure to Mines: Lowry Mine, MSHA I.D. No. Chemicals (UNSCEGHS) pre-register may delay your access into 36–09287 and Heilwood Mine, MSHA AGENCY: Occupational Safety and Health the DOT Headquarters building. I.D. No. 36–09407, located in Indiana Administration (OSHA), Department of Additionally, if you are attending in County, Pennsylvania; Penfield Mine, Labor. person, arrive early to allow time for MSHA I.D. No. 36–09355, located in security checks necessary to access the ACTION: Notice of public meeting. Clearfield County, Pennsylvania; and building. Mine 78, MSHA I.D. No. 36–09371, SUMMARY: This notice is to advise Conference call-in and ‘‘Skype located in Somerset County, interested persons that on Tuesday, meeting’’ capability will be provided for Pennsylvania. November 13, 2018, OSHA will conduct both meetings. Information on how to Regulation Affected: 30 CFR 75.503 a public meeting to discuss proposals in access the conference call and ‘‘Skype (Permissible electric face equipment; preparation for the 36th session of the meeting’’ will be posted when available maintenance) and 30 CFR 18.35(a)(5)(i) United Nations Sub-Committee of at: https://www.phmsa.dot.gov/ (Portable (trailing) cables and cords). Experts on the Globally Harmonized international-program/international- • Docket Number: M–2018–013–C. System of Classification and Labelling program-overview under Upcoming FR Notice: 83 FR 17686 (4/23/2018). of Chemicals (UNSCEGHS) to be held Events. This information will also be Petitioner: The Coteau Properties December 5 through December 7, 2018, posted on OSHA’s Hazard Company, 204 County Road, Beulah, in Geneva, Switzerland. OSHA, along Communication website on the North Dakota 58523–9475. with the U.S. Interagency Globally international tab at: https://

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www.osha.gov/dsg/hazcom/hazcom_ www.regulations.gov (Docket No. DEPARTMENT OF LABOR international.html#meeting-notice. PHMSA–2018–0024; Notice No. 2018– FOR FURTHER INFORMATION CONTACT: At 11), and on the PHMSA website at: Office of Workers’ Compensation the Department of Transportation, https://www.phmsa.dot.gov/ Programs please contact Mr. Steven Webb or Mr. international-program/international- Proposed Extension of Existing Aaron Wiener, Office of Hazardous program-overview. Collection; Comment Request Materials Safety, Department of The primary purpose of PHMSA’s Transportation, Washington, DC 20590, meeting is to prepare for the 54th ACTION: Notice. telephone: (202) 366–8553. session of the UNSCE TDG. This session At the Department of Labor, please represents the third meeting scheduled SUMMARY: The Department of Labor, as contact Ms. Maureen Ruskin, OSHA for the 2017–2018 biennium. UNSCOE part of its continuing effort to reduce Directorate of Standards and Guidance, paperwork and respondent burden, Department of Labor, Washington DC will consider proposals for the 21st Revised Edition of the United Nations conducts a pre-clearance consultation 20210, telephone: (202) 693–1950, program to provide the general public email: [email protected]. Recommendations on the Transport of Dangerous Goods (Model Regulations), and Federal agencies with an SUPPLEMENTARY INFORMATION: which may be implemented into opportunity to comment on proposed The OSHA Meeting: OSHA is hosting and/or continuing collections of an open informal public meeting of the relevant domestic, regional, and international regulations from January 1, information in accordance with the U.S. Interagency GHS Coordinating paperwork Reduction Act of 1995 2021. Copies of working documents, Group to provide interested groups and (PRA95). This program helps to ensure informal documents, and the meeting individuals with an update on GHS- that requested data can be provided in related issues and an opportunity to agenda may be obtained from the United the desired format, reporting burden express their views orally and in writing Nations (UN) Transport Division’s (time and financial resources) is for consideration in developing U.S. website at https://www.unece.org/trans/ minimized, collection instruments are Government positions for the upcoming main/dgdb/dgsubc3/c32018.html. clearly understood, and the impact of UNSCEGHS meeting. During this meeting, PHMSA is also collection requirements on respondents General topics on the agenda include: soliciting input relative to preparing for can be properly assessed. Currently, the • Review of Working Papers. Office of Workers’ Compensation • the 54th session of the UNSCE TDG as Correspondence Group updates. (OWCP) is soliciting comments • well as potential new work items which Regulatory Cooperation Council may be considered for inclusion in its concerning the proposed collection: (RCC) update. international agenda. Following the Waiver of Service by Registered or Information on the work of the 54th session of the UNSCE TDG, a copy Certified Mail for Employers and/or UNSCEGHS including meeting agendas, Insurance Carriers (LS–801) and Waiver reports, and documents from previous of the Sub-Committee’s report will be available at the UN Transport Division’s of Service by Registered or Certified sessions can be found on the United Mail for Claimants and Authorized Nations Economic Commission for website at http://www.unece.org/trans/ main/dgdb/dgsubc3/c3rep.html. Representatives (LS–802). A copy of the Europe (UNECE) Transport Division proposed information collection request website located at the following web Additional information regarding the can be obtained by contacting the office address: http://www.unece.org/trans/ UNSCE TDG and related matters can be listed below in the address section of _ _ danger/publi/ghs/ghs welcome e.html. found on PHMSA’s website at https:// this Notice. The UNSCEGHS bases its decisions www.phmsa.dot.gov/international- DATES: Written comments must be on Working papers. The Working Papers program/international-program- submitted to the office listed in the for the 36th session of the UNSCEGHS overview. addresses section below on or before are located at: https://www.unece.org/ Authority and Signature: This December 31, 2018. trans/main/dgdb/dgsubc3/c32018.html. Informal Papers submitted to the document was prepared under the ADDRESSES: You may submit comments UNSCEGHS provide information for the direction of Loren Sweatt, Deputy by mail, delivery service, or by hand to Sub-Committee and are used either as a Assistant Secretary of Labor for Ms. Yoon Ferguson, U.S. Department of mechanism to provide information to Occupational Safety and Health, U.S. Labor, 200 Constitution Ave. NW, Room the Sub-Committee or as the basis for Department of Labor, pursuant to S–3323, Washington, DC 20210; by fax future Working Papers. Informal Papers sections 4, 6, and 8 of the Occupational (202) 354–9647; or email to for the 36th session of the UNSCEGHS Safety and Health Act of 1970 (29 U.S.C. [email protected]. Please use only are located at: https://www.unece.org/ 653, 655, 657), and Secretary’s Order 1– one method of transmission for trans/main/dgdb/dgsubc4/c4inf35.html. 2012 (77 FR 3912), (Jan. 25, 2012). comments (mail/delivery, fax or email). In addition to participating at the Please note that comments submitted Signed at Washington, DC, on October 24, after the comment period will not be public meeting, interested parties may 2018. submit comments on the Working and considered. Loren Sweatt, Informal Papers for the 36th session of SUPPLEMENTARY INFORMATION: the UNSCEGHS to the docket Deputy Assistant Secretary of Labor for established for International/Globally Occupational Safety and Health. I. Background Harmonized System (GHS) efforts at [FR Doc. 2018–23647 Filed 10–29–18; 8:45 am] The Office of Workers’ Compensation http://www.regulations.gov, Docket No. BILLING CODE 4510–26–P Programs (OWCP) administers the OSHA–2016–0005. Longshore and Harbor Workers’ The PHMSA Meeting: The Federal Compensation Act (LHWCA). The Act Register notice and additional detailed provides benefits to workers’ injured in information relating to PHMSA’s public maritime employment on the navigable meeting will be available upon waters of the United States or in an publication at: http:// adjoining area customarily used by an

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employer in loading, unloading, electronic, mechanical, or other meeting times and dates. All meetings repairing, or building a vessel. In technological collection techniques or are Eastern time and ending times are addition, several acts extend the other forms of information technology, approximate. Longshore Act’s coverage to certain e.g., permitting electronic submissions ADDRESSES: National Endowment for the other employees. of responses. Arts, Constitution Center, 400 7th St. The Longshore and Harbor Workers’ SW, Washington, DC 20506. Compensation Act (LHWCA), at 33 III. Current Actions U.S.C. 919(e), requires that any order The Department of Labor seeks the FOR FURTHER INFORMATION CONTACT: rejecting or making an LHWCA award (a extension of approval of this Further information with reference to compensation order) be filed in the information collection in order to carry these meetings can be obtained from Ms. appropriate district director’s office of out its responsibility to meet the Sherry Hale, Office of Guidelines & the Office of Workers’ Compensation statutory requirements to provide Panel Operations, National Endowment Programs (OWCP), and that copies be compensation or death benefits under for the Arts, Washington, DC 20506; sent by registered or certified mail to the the Act to workers and survivors [email protected], or call 202/682–5696. claimant and the employer. The covered by the Act. SUPPLEMENTARY INFORMATION: The implementing regulations at 20 CFR Agency: Office of Workers’ closed portions of meetings are for the 702.349(b) allow parties and their Compensation Programs. purpose of Panel review, discussion, representatives to waive certified mail Type of Review: Extension. evaluation, and recommendations on service and consent to electronic service Title: Request for Electronic Service of financial assistance under the National instead. The compensation order Orders—Waiver of Certified Mail Foundation on the Arts and the notifies Employers/Carriers that Requirements. Humanities Act of 1965, as amended, payment of LHWCA compensation is OMB Number: 1240–0053. including information given in due within 10 days of filing. If Agency Number: LS–801 and LS–802. confidence to the agency. In accordance Affected Public: Claimants, compensation is not paid within that with the determination of the Chairman employers, large insurance companies, time frame, an additional 20% in of July 5, 2016, these sessions will be and representatives. compensation must be paid [see closed to the public pursuant to Total Respondents: 9,240. subsection (c)(6) of section 552b of title LHWCA § 914(f)]. Total Annual Responses: 9,240. The information collected will be Estimated Total Burden Hours: 770. 5, United States Code. used by OWCP to more efficiently serve Estimated Time per Response: 5 The upcoming meetings are: compensation orders by email instead of minutes. Visual Arts (review of applications): by registered or certified mail. Form LS– Frequency: On occasion. This meeting will be closed. 801 will be completed by the employer/ Total Burden Cost (capital/startup): Date and time: November 29, 2018; insurance carrier and/or an authorized $0. 11:30 a.m. to 1:30 p.m. representative and forwarded to the Total Burden Cost (operating/ Visual Arts (review of applications): District Director indicating waiver of maintenance): $0. This meeting will be closed. service by registered or certified mail Comments submitted in response to Date and time: November 29, 2018; and designation of receipt by email this notice will be summarized and/or 2:30 p.m. to 4:30 p.m. instead. The LS–802 will be completed included in the request for Office of Visual Arts (review of applications): by the claimants and/or an authorized Management and Budget approval of the This meeting will be closed. representative and forwarded to the information collection request; they will Date and time: November 30, 2018; District Director indicating waiver of also become a matter of public record. 11:30 a.m. to 1:30 p.m. service by registered or certified mail Dated: October 25, 2018. Visual Arts (review of applications): This meeting will be closed. and designation of receipt by email Yoon Ferguson, instead. This information collection is Date and time: November 30, 2018; Agency Clearance Officer, Office of Workers’ currently approved for use through 2:30 p.m. to 4:30 p.m. Compensation Programs, US Department of Museums (review of applications): This February 28, 2019. Labor. meeting will be closed. II. Review Focus [FR Doc. 2018–23674 Filed 10–29–18; 8:45 am] Date and time: December 4, 2018; The Department of Labor is BILLING CODE 4510–CF–P 11:30 a.m. to 1:30 p.m. particularly interested in comments Museums (review of applications): This which: meeting will be closed. * Evaluate whether the proposed NATIONAL FOUNDATION ON THE Date and time: December 4, 2018; collection of information is necessary ARTS AND THE HUMANITIES 2:30 p.m. to 4:30 p.m. for the proper performance of the Presenting & Multidisciplinary Works National Endowment for the Arts functions of the agency, including (review of applications): This whether the information will have Arts Advisory Panel Meetings meeting will be closed. practical utility; Date and time: December 4, 2018; * Evaluate the accuracy of the AGENCY: National Endowment for the 2:00 p.m. to 4:00 p.m. agency’s estimate of the burden of the Arts. Museums (review of applications): This proposed collection of information, ACTION: Notice of meetings. meeting will be closed. including the validity of the Date and time: December 5, 2018; methodology and assumptions used; SUMMARY: Pursuant to the Federal 11:30 a.m. to 1:30 p.m. * Enhance the quality, utility and Advisory Committee Act, as amended, Museums (review of applications): This clarity of the information to be notice is hereby given that 28 meetings meeting will be closed. collected; and of the Arts Advisory Panel to the Date and time: December 5, 2018; * Minimize the burden of the National Council on the Arts will be 2:30 p.m. to 4:30 p.m. collection of information on those who held by teleconference. Presenting & Multidisciplinary Works are to respond, including through the DATES: See the SUPPLEMENTARY (review of applications): This use of appropriate automated, INFORMATION section for individual meeting will be closed.

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Date and time: December 5, 2018; Date and time: December 13, 2018; the National Council on the Humanities 2:00 p.m. to 4:00 p.m. 3:30 p.m. to 5:30 p.m. will be held on November 15, 2018, as Our Town (review of applications): This Media Arts (review of applications): follows: The policy discussion session meeting will be closed. This meeting will be closed. (open to the public) will convene at 9:00 Date and time: December 5, 2018; Date and time: December 13, 2018; a.m. until approximately 10:30 a.m., 2:30 p.m. to 5:00 p.m. 11:30 a.m. to 1:30 p.m. followed by the discussion of specific Arts Education (review of applications): Our Town (review of applications): This grant applications and programs before This meeting will be closed. meeting will be closed. the Council (closed to the public) from Date and time: December 6, 2018; Date and time: December 13, 2018; 10:30 a.m. until 12:00 p.m. The 11:30 a.m. to 1:30 p.m. 2:30 p.m. to 5:00 p.m. following Committees will meet in the Arts Education (review of applications): Dated: October 25, 2018. NEH offices: This meeting will be closed. Sherry Hale, Digital Humanities: Room 4085. Date and time: December 6, 2018; Education Programs: Room 2002. 2:30 p.m. to 4:30 p.m. Staff Assistant, National Endowment for the Federal/State Partnership: Room Presenting & Multidisciplinary Works Arts. 4089. (review of applications): This [FR Doc. 2018–23660 Filed 10–29–18; 8:45 am] Preservation and Access: Room 4002. meeting will be closed. BILLING CODE 7537–01–P Public Programs: Room P002. Date and time: December 6, 2018; Research Programs: Room P003. 2:00 p.m. to 4:00 p.m. Our Town (review of applications): This NATIONAL FOUNDATION ON THE The plenary session of the National meeting will be closed. ARTS AND THE HUMANITIES Council on the Humanities will convene Date and time: December 6, 2018; on November 16, 2018, at 9:00 a.m. in 11:00 a.m. to 1:30 p.m. National Endowment for the the Conference Center at Constitution Our Town (review of applications): This Humanities Center. The agenda for the morning session (open to the public) will be as meeting will be closed. Meeting of National Council on the Date and time: December 6, 2018; follows: Humanities 2:30 p.m. to 5:00 p.m. A. Minutes of the Previous Meeting Presenting & Multidisciplinary Works AGENCY: National Endowment for the B. Reports (review of applications): This Humanities. 1. Chairman’s Remarks meeting will be closed. ACTION: Notice of meeting. 2. Senior Deputy Chairman’s Remarks Date and time: December 7, 2018; 1. Presentation by guest speaker 2:00 p.m. to 4:00 p.m. SUMMARY: Pursuant to the Federal Kaywin Feldman, Minneapolis Folk & Traditional Arts (review of Advisory Committee Act, notice is Institute of Art applications): This meeting will be hereby given that the National Council 3. Congressional Affairs and Budget closed. on the Humanities will meet to advise Reports Date and time: December 11, 2018; the Chairman of the National 4. Reports on Policy and General 1:00 p.m. to 3:00 p.m. Endowment for the Humanities (NEH) Matters Our Town (review of applications): This with respect to policies, programs and a. Digital Humanities meeting will be closed. procedures for carrying out his b. Education Programs Date and time: December 11, 2018; functions; to review applications for c. Federal/State Partnership 11:00 a.m. to 1:30 p.m. financial assistance under the National d. Preservation and Access Our Town (review of applications): This Foundation on the Arts and Humanities e. Public Programs meeting will be closed. Act of 1965 and make recommendations f. Research Programs Date and time: December 11, 2018; thereon to the Chairman; and to The remainder of the plenary session 2:30 p.m. to 5:00 p.m. consider gifts offered to NEH and make will be for consideration of specific Arts Education (review of applications): recommendations thereon to the applications and therefore will be This meeting will be closed. Chairman. Date and time: December 12, 2018; closed to the public. 1:30 p.m. to 3:30 p.m. DATES: The meeting will be held on As identified above, portions of the Media Arts (review of applications): Thursday, November 15, 2018, from meeting of the National Council on the This meeting will be closed. 9:00 a.m. until 12:00 p.m., and Friday, Humanities will be closed to the public Date and time: December 12, 2018; November 16, 2018, from 9:00 a.m. until pursuant to sections 552b(c)(4), 2:30 p.m. to 4:30 p.m. adjourned. 552b(c)(6), and 552b(c)(9)(B) of Title 5 U.S.C., as amended. The closed sessions Our Town (review of applications): This ADDRESSES: The meeting will be held at will include review of personal and/or meeting will be closed. Constitution Center, 400 7th Street SW, proprietary financial and commercial Date and time: December 12, 2018; Washington, DC 20506. See information given in confidence to the 11:00 a.m. to 1:30 p.m. SUPPLEMENTARY INFORMATION for room agency by grant applicants, and Folk & Traditional Arts (review of numbers. applications): This meeting will be discussion of certain information, the closed. FOR FURTHER INFORMATION CONTACT: premature disclosure of which could Date and time: December 13, 2018; Elizabeth Voyatzis, Committee significantly frustrate implementation of 1:00 p.m. to 3:00 p.m. Management Officer, 400 7th Street SW, proposed agency action. I have made Local Arts Agencies (review of 4th Floor, Washington, DC 20506; (202) this determination pursuant to the applications): This meeting will be 606–8322; [email protected]. authority granted me by the Chairman’s closed. SUPPLEMENTARY INFORMATION: The Delegation of Authority to Close Date and time: December 13, 2018; National Council on the Humanities is Advisory Committee Meetings dated 1:00 p.m. to 3:00 p.m. meeting pursuant to the National April 15, 2016. Local Arts Agencies (review of Foundation on the Arts and Humanities Please note that individuals planning applications): This meeting will be Act of 1965 (20 U.S.C. 951–960, as to attend the public sessions of the closed. amended). The Committee meetings of meeting are subject to security screening

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procedures. If you wish to attend any of telephone: 301–287–9127; email: under Section I.B, ‘‘Submitting the public sessions, please inform NEH [email protected]. For technical Comments.’’ as soon as possible by contacting questions, contact the individuals listed • NRC’s PDR: You may examine and Melanie Gaylord at (202) 606–8322 or in the FOR FURTHER INFORMATION purchase copies of public documents at [email protected]. Please also CONTACT section of this document. the NRC’s PDR, Room O1–F21, One provide advance notice of any special • Mail comments to: May Ma, Office White Flint North, 11555 Rockville needs or accommodations, including for of Administration, Mail Stop: TWFN–7– Pike, Rockville, Maryland 20852. a sign language interpreter. A60M, U.S. Nuclear Regulatory B. Submitting Comments Dated: October 24, 2018. Commission, Washington, DC 20555– 0001. Please include Docket ID NRC–2018– Elizabeth Voyatzis, For additional direction on obtaining 0155 in your comment submission. Committee Management Officer. information and submitting comments, The NRC cautions you not to include [FR Doc. 2018–23591 Filed 10–29–18; 8:45 am] see ‘‘Obtaining Information and identifying or contact information that BILLING CODE 7536–01–P Submitting Comments’’ in the you do not want to be publicly SUPPLEMENTARY INFORMATION section of disclosed in your comment submission. this document. The NRC will post all comment submissions at http:// NUCLEAR REGULATORY FOR FURTHER INFORMATION CONTACT: COMMISSION Lloyd Desotell, Office of Nuclear www.regulations.gov as well as enter the comment submissions into ADAMS. Material Safety and Safeguards, [NRC–2018–0155] The NRC does not routinely edit telephone: 301–415–5969, email: comment submissions to remove [email protected]; or Karen Instructions for Completing NRC’s identifying or contact information. Uniform Low-Level Radioactive Waste Pinkston, Office of Nuclear Material If you are requesting or aggregating Manifest Safety and Safeguards, telephone: 301– comments from other persons for 415–3650, email: Karen.Pinkston@ submission to the NRC, then you should AGENCY: Nuclear Regulatory nrc.gov; Both are staff of the U.S. inform those persons not to include Commission. Nuclear Regulatory Commission, identifying or contact information that ACTION: Draft NUREG; request for Washington, DC 20555–0001. they do not want to be publicly comment. SUPPLEMENTARY INFORMATION: disclosed in their comment submission. SUMMARY: The U.S. Nuclear Regulatory I. Obtaining Information and Your request should state that the NRC Commission (NRC) is issuing for public Submitting Comments does not routinely edit comment submissions to remove such information comment a draft NUREG, NUREG/BR– A. Obtaining Information 0204, Rev. 3, ‘‘Instructions for before making the comment Completing NRC’s Uniform Low-Level Please refer to Docket ID NRC–2018– submissions available to the public or Radioactive Waste Manifest.’’ This 0155 when contacting the NRC about entering the comment into ADAMS. the availability of information for this document provides instructions to II. Discussion prepare NRC Form 540 (Uniform Low- action. You may obtain publicly- available information related to this NUREG/BR–0204, Rev. 3, Level Radioactive Waste Manifest ‘‘Instructions for Completing the NRC’s (Shipping Paper)), NRC Form 541 action by any of the following methods: • Federal Rulemaking website: Go to Uniform Low-Level Radioactive Waste (Uniform Low-Level Radioactive Waste https://www.regulations.gov and search Manifest,’’ provides guidance on Manifest (Container and Waste for Docket ID NRC–2018–0155. completing NRC Forms 540, 541, and Description)), and NRC Form 542 • NRC’s Agencywide Documents 542 (i.e., the NRC’s Uniform Low-Level (Uniform Low-Level Radioactive Waste Access and Management System Waste Manifest). The last revision to Manifest (Manifest Index and Regional (ADAMS): You may obtain publicly- this NUREG/BR, Rev. 2, was published Compact Tabulation)). NRC Forms 540 available documents online in the in July 1998. In SECY–13–0001, ‘‘Staff and 541 must be prepared for low-level ADAMS Public Documents collection at Recommendations for Improving the radioactive waste intended for ultimate http://www.nrc.gov/reading-rm/ Integration of the Ongoing 10 CFR part disposal at a licensed low-level adams.html. To begin the search, select 61 Rulemaking Initiatives’’ (ADAMS radioactive waste land disposal facility. ‘‘Begin Web-based ADAMS Search.’’ For Accession No. ML12199A412), staff NRC Form 542 is required only if problems with ADAMS, please contact noted that stakeholders suggested that processors and collectors of low-level the NRC’s Public Document Room (PDR) NUREG/BR–0204 needs to be rewritten radioactive waste are shipping low-level reference staff at 1–800–397–4209, 301– and that assumptions concerning the radioactive waste attributed to others for 415–4737, or by email to pdr.resource@ reporting of certain hard-to-detect disposal at a licensed low-level nrc.gov. NUREG/BR–0204, Rev. 3, isotopes (i.e., H–3, C–14, Tc-99 and I– radioactive waste land disposal facility. ‘‘Instructions for Completing NRC’s 129) on the Uniform Waste Manifest DATES: Submit comments by December Uniform Low-Level Radioactive Waste should be revisited. To address these 31, 2018. Comments received after this Manifest’’ is available in ADAMS under stakeholder comments, the NRC staff date will be considered if it is practical Accession No. ML18261A002. The NRC held two public workshops in March to do so, but the Commission is able to has prepared a draft regulatory analysis and June of 2013 to collect comments ensure consideration only for comments for this proposed guidance. The analysis specifically on NUREG/BR–0204. received before this date. examines the costs and benefits of the Comments received on the NUREG/BR– ADDRESSES: You may submit comments alternatives considered by the NRC. The 0204, Rev. 2, as a result of these by any of the following methods: NRC requests public comment on the workshops can be found on the Federal • Federal Rulemaking Website: Go to draft regulatory analysis. The draft Rulemaking website http://www.regulations.gov and search regulatory analysis can be found under (www.regulations.gov) under Docket ID for Docket ID NRC–2018–0155. Address ADAMS Accession No. ML18275A039. NRC–2013–0035. Many of the questions about dockets IDs in Comments on the draft analysis may be comments received focused on the Regulations.gov to Jennifer Borges; submitted to the NRC as indicated reporting of the hard-to-detect isotopes

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(i.e., H–3, C–14, Tc-99 and I–129) on the the draft Rev. 3 to NUREG/BR–0204, Week of October 29, 2018 Uniform Low-Level Radioactive Waste and on the draft regulatory analysis. The Monday, October 29, 2018 Manifest. NRC staff will consider any comments In 2013, the NRC staff also identified received in preparing the final version 9:00 a.m. Transformation at the NRC additional changes that may be needed of Rev. 3 and the revised NRC Forms (Public) (Contact: Kevin Williams: for the Uniform Low-Level Radioactive 540, 541, and 542. In responding, 301–415–1611) Waste Manifest forms and associated commenters are encouraged to provide This meeting will be webcast live at guidance in NUREG/BR–0204 as a part specific suggestions and the basis for the web address—http://www.nrc.gov/. of the ongoing part 61 of title 10 of the suggestions offered. Specifically, the Week of November 5, 2018—Tentative Code of Federal Register (10 CFR) NRC staff requests comment on the rulemaking (Docket ID NRC–2009– following questions: There are no meetings scheduled for 0257). The 10 CFR part 61 rulemaking, the week of November 5, 2018. however, had not progressed far enough 1. Do the proposed revised Uniform Week of November 12, 2018—Tentative for the specific changes to the Uniform Low-Level Radioactive Waste Manifest Low-Level Radioactive Waste Manifest Forms 540, 541, and 542 request all of There are no meetings scheduled for forms and NUREG/BR–0204 to be the information that is needed for the the week of November 12, 2018. transport and disposal of low-level known with certainty. Week of November 19, 2018—Tentative Therefore, staff developed Regulatory radioactive waste to be safely managed? Information Summary (RIS–15–002) to Is there any additional information that There are no meetings scheduled for address stakeholder concerns regarding should be collected? the week of November 19, 2018. the reporting of hard-to-detect 2. Is any additional guidance or Week of November 26, 2018—Tentative radionuclides on the Uniform Low- clarification needed in the instructions Thursday, November 29, 2018 Level Radioactive Waste Manifest. This for filling out the Uniform Low-Level RIS, titled ‘‘Reporting of H-3, C-14, Tc- Radioactive Waste Manifest Forms in 10:00 a.m. Briefing on Security Issues 99, and I-129 on the Uniform Waste NUREG/BR–0204? (Closed Ex. 1) Manifest’’ (ADAMS Accession No. ML14272A217), informs addressees of 3. NRC Form 541 has lists of container Week of December 3, 2018 the option to use indirect methods to description codes (note 1), waste Monday, December 3, 2018 determine the activity of H-3, C-14, Tc- descriptor codes (note 2), and sorption 10:00 a.m. Briefing on Equal 99, and I-129 reported on the Uniform and solidification media (note 3) that Low-Level Radioactive Waste Manifest have not been updated recently. Are Employment Opportunity, when the radionuclide is present at a there any items that should be added to Affirmative Employment, and Small concentration less than the lower limit these lists based on new technology or Business (Public) (Contact: Larniece of detection (LLD). The request for changes to industry practices? Are there McKoy Moore: 301–415–1942) comments on draft RIS was published any items on these lists that should be This meeting will be webcast live at on in the Federal Register on June 2, deleted because they are no longer in the web address—http://www.nrc.gov/. 2014 (79 FR 31348), and the final RIS use or for any other reason? Should the Thursday, December 6, 2018 was published on February 18, 2015. items in the lists be combined in any In September of 2017, the NRC way? 10:00 a.m. Meeting with Advisory received direction from the Commission Committee on Reactor Safeguards Dated at Rockville, Maryland, this 25th day on the part 61 rulemaking in SRM– (Public) (Contact: Mark Banks: 301– of October, 2018. SECY–16–0106 (ADAMS Accession No. 415–3718) ML17251B147), and the NRC staff For the Nuclear Regulatory Commission. This meeting will be webcast live at determined that there was enough Andrea L. Kock, the Web address—http://www.nrc.gov/. certainty in the portions of the part 61 Deputy Director, Division of CONTACT PERSON FOR MORE INFORMATION: rulemaking that affected the Uniform Decommissioning, Uranium Recovery, and For more information or to verify the Low-Level Radioactive Waste Manifest Waste Programs, Office of Nuclear Material status of meetings, contact Denise to issue a draft of the manifest forms Safety and Safeguards. McGovern at 301–415–0681 or via email and the instructions in NUREG/BR– [FR Doc. 2018–23694 Filed 10–29–18; 8:45 am] at [email protected]. The 0204 for comment. The NRC staff BILLING CODE 7590–01–P schedule for Commission meetings is considered the comments received in subject to change on short notice. 2013 when revising these documents. The NRC Commission Meeting Major areas of revision include: NUCLEAR REGULATORY Schedule can be found on the internet Updated references to Department of COMMISSION at: http://www.nrc.gov/public-involve/ Transportation (DOT) regulations to public-meetings/schedule.html. reflect the current DOT regulations, [NRC–2018–0001] The NRC provides reasonable additional discussion on the reporting accommodation to individuals with of inventories based on LLD values, the Sunshine Act Meetings disabilities where appropriate. If you potential use of indirect methods to need a reasonable accommodation to determine these inventories, including TIME AND DATE: Weeks of October 29, participate in these public meetings, or the use of indirect methods in waste November 5, 12, 19, 26, December 3, need this meeting notice or the classification, clarification of the 2018. transcript or other information from the certification statement on Form 540, and public meetings in another format (e.g., overall improvements to the clarity of PLACE: Commissioners’ Conference braille, large print), please notify NUREG/BR–0204. Room, 11555 Rockville Pike, Rockville, Kimberly Meyer-Chambers, NRC The NRC is requesting public Maryland. Disability Program Manager, at 301– comments on the draft revised Uniform 287–0739, by videophone at 240–428– STATUS: Public and Closed. Low-Level Radioactive Waste Manifest 3217, or by email at Kimberly.Meyer- (NRC Forms 540, 541, and 542) and on MATTERS TO BE CONSIDERED: [email protected]. Determinations on

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requests for reasonable accommodation ADDRESSES: Please refer to Docket ID exemption is necessary in order to issue will be made on a case-by-case basis. NRC–2008–0252 when contacting the the requested license amendment, the Members of the public may request to NRC about the availability of NRC granted the exemption and issued receive this information electronically. information regarding this document. the amendment concurrently, rather If you would like to be added to the You may obtain publicly-available than in sequence. This included issuing distribution, please contact the Nuclear information related to this document a combined safety evaluation containing Regulatory Commission, Office of the using any of the following methods: the NRC staff’s review of both the Secretary, Washington, DC 20555 (301– • Federal Rulemaking Website: Go to exemption request and the license 415–1969), or you may email http://www.regulations.gov and search amendment. The exemption met all [email protected] or for Docket ID NRC–2008–0252. Address applicable regulatory criteria set forth in [email protected]. questions about NRC Docket IDs in Sections 50.12 and 52.7 of 10 CFR part Dated at Rockville, Maryland, this 25th day Regulations.gov to Jennifer Borges; 52. The license amendment was found of October, 2018. telephone: 301–287–9127; email: to be acceptable as well. The combined safety evaluation is available in ADAMS For the Nuclear Regulatory Commission. [email protected]. For technical questions, contact the individual listed under Accession No. ML18207A262. Denise L. McGovern, in the FOR FURTHER INFORMATION Identical exemption documents Policy Coordinator, Office of the Secretary. CONTACT section of this document. (except for referenced unit numbers and [FR Doc. 2018–23764 Filed 10–26–18; 11:15 am] • NRC’s Agencywide Documents license numbers) were issued to SNC for BILLING CODE 7590–01–P Access and Management System VEGP Units 3 and 4 (COLs NPF–91 and (ADAMS): You may obtain publicly- NPF–92). The exemption documents for available documents online in the VEGP Units 3 and 4 can be found in NUCLEAR REGULATORY ADAMS Public Documents collection at ADAMS under Accession Nos. COMMISSION http://www.nrc.gov/reading-rm/ ML18235A031 and ML18235032, adams.html. To begin the search, select respectively. The exemption is [Docket Nos. 52–025 and 52–026; NRC– ‘‘Begin Web-based ADAMS Search.’’ For reproduced (with the exception of 2008–0252] problems with ADAMS, please contact abbreviated titles and additional the NRC’s Public Document Room (PDR) citations) in Section II of this document. Southern Nuclear Operating Company, reference staff at 1–800–397–4209, 301– The amendment documents for COLs Inc., Vogtle Electric Generating Plant, 415–4737, or by email to pdr.resource@ NPF–91 and NPF–92 are available in Units 3 and 4; Changes to Tier 2* nrc.gov. The ADAMS accession number ADAMS under Accession Nos. Departure Evaluation Process for each document referenced (if it is ML18235A033 and ML18235A035, respectively. A summary of the AGENCY: Nuclear Regulatory available in ADAMS) is provided the amendment documents is provided in Commission. first time that it is mentioned in this Section III of this document. ACTION: Exemption and combined document. The request for the license amendment; issuance. amendment and exemption was II. Exemption submitted by letter dated December 21, Reproduced below is the exemption 2017, and available in ADAMS under SUMMARY: The U.S. Nuclear Regulatory document issued to VEGP Units 3 and Accession No. ML17355A416. Commission (NRC) is granting an 4. It makes reference to the combined • NRC’s PDR: You may examine and exemption for prior NRC approval of safety evaluation that provides the purchase copies of public documents at any departure from Tier 2* information reasoning for the findings made by the the NRC’s PDR, Room O1–F21, One or any departure from Tier 2 NRC (and listed under Item 1) in order White Flint North, 11555 Rockville information that involves a change to or to grant the exemption: departure from Tier 2* information, Pike, Rockville, Maryland 20852. 1. In a letter dated December 21, 2017, provided that specified criteria are not FOR FURTHER INFORMATION CONTACT: as supplemented by letters dated April met, and is issuing License Amendment Chandu Patel, Office of New Reactors, 6, May 11, June 18, August 3, August 10, Nos. 142 and 141 to Combined Licenses U.S. Nuclear Regulatory Commission, and September 13, 2018, SNC requested (COLs) NPF–91 and NPF–92, Washington, DC 20555–0001; telephone: from the Commission an exemption respectively. The COLs were issued to 301–415–3025; email: Chandu.Patel@ from the requirements of 10 CFR part Southern Nuclear Operating Company, nrc.gov. 52, Appendix D, ‘‘Design Certification Inc., and Georgia Power Company, SUPPLEMENTARY INFORMATION: Rule for the AP1000 Design,’’ Section Oglethorpe Power Corporation, MEAG VIII, ‘‘Processes for Changes and Power SPVM, LLC, MEAG Power SPVJ, I. Introduction Departures,’’ paragraphs VIII.B.5.a, LLC, MEAG Power SPVP, LLC, and the The NRC is granting an exemption VIII.B.6.b, and VIII.B.6.c, for prior NRC City of Dalton, Georgia (collectively from paragraphs B.5.a, B.6.b, and B.6.c approval of any departure from Tier 2* SNC); for construction and operation of of section VIII, ‘‘Processes for Changes information or any departure from Tier the Vogtle Electric Generating Plant and Departures,’’ of Appendix D, of Part 2 information that involves a change to (VEGP) Units 3 and 4, located in Burke 52 of Title 10 of the Code of Federal or departure from Tier 2* information, County, Georgia. Regulations (10 CFR), and issuing provided that specified criteria are not The granting of the exemption allows License Amendment No. to COLs, NPF– met. SNC specified the criteria in a new the imposition of License Condition 91 and NPF–92, to SNC. With the license condition in license amendment 2.D.13 asked for in the amendment requested amendment, SNC sought request (LAR) 17–037, ‘‘Changes to the request. Because the acceptability of the proposed License Condition 2.D.13 and Tier 2* Departure Evaluation Process,’’ exemption was determined in part by proposed changes that would revise the which SNC submitted together with the the acceptability of the amendment, the Updated Final Safety Analysis Report exemption request. The proposed exemption and amendment are being Tier 2 information. license condition would allow SNC to issued concurrently. Part of the justification for granting apply the change process for Tier 2 DATES: The exemption and amendment the exemption was provided by the information in 10 CFR part 52, were issued on September 20, 2018. review of the amendment. Because the Appendix D, Section VIII.B.5, to a

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proposed departure from Tier 2* findings as required by the Act and the (Open)—The ACRS Chairman will make information in the UFSAR (which Commission’s rules and regulations in opening remarks regarding the conduct includes the plant-specific design 10 CFR Chapter I, which are set forth in of the meeting. certification document (DCD), provided the license amendment. 8:35 a.m.–10:30 a.m.: Waterford the criteria in the new condition are not A notice of consideration of issuance Steam Electric Station, Unit 3 License met. For the reasons set forth in Section of amendment to facility operating Renewal Application (Open)—The 3.2 of the NRC staff’s Safety Evaluation, license or COL, as applicable, proposed Committee will have briefings by and which can be found at ADAMS no significant hazards consideration discussion with representatives of the Accession No. ML18207A262, the determination, and opportunity for a NRC staff and Entergy regarding the Commission finds that: hearing in connection with these safety evaluation associated with the A. the exemption is authorized by actions, was published in the Federal subject license renewal application. law; Register on February 13, 2018 (83 FR 10:45 a.m.–12:45 p.m.: River Bend B. the exemption presents no undue 6234). Public comments were received Nuclear Generating Station, Unit 1 risk to public health and safety; during the 30-day comment period. The License Renewal Application (Open)— C. the exemption is consistent with staff’s responses to the comments The Committee will have briefings by the common defense and security; appear in Section 5.0 of the Safety and discussion with representatives of D. special circumstances are present Evaluation. the NRC staff and Entergy regarding the in that the application of the rule in this The Commission has determined that safety evaluation associated with the circumstance is not necessary to serve these amendments satisfy the criteria for subject license renewal application. the underlying purpose of the rule; categorical exclusion in accordance 1:45 p.m.–2:45 p.m.: Preparation for 2. Accordingly, SNC is granted an with 10 CFR 51.22. Therefore, pursuant Meeting with Commission (Open)—The exemption from the requirements to to 10 CFR 51.22(b), no environmental Committee will prepare for the obtain prior NRC approval for any impact statement or environmental upcoming meeting with the Commission departure from Tier 2* information and assessment need be prepared for these in December. an exemption from the requirement to amendments. 3 p.m.–6 p.m.: Preparation of ACRS obtain prior NRC approval for any Reports (Open)—The Committee will departure from Tier 2 information that IV. Conclusion continue its discussion of proposed involves a change to or departure from Using the reasons set forth in the ACRS reports. Tier 2* information, as described in the combined safety evaluation, the staff Friday, November 2, 2018, Conference licensee’s request dated December 21, granted the exemption and issued the Room 1C3 & 1C5, Three White Flint 2017, as supplemented by letters dated amendment that SNC requested on North, 11601 Landsdown Street, North April 6, May 11, June 18, August 3, September 20, 2018. The exemption and Bethesda, MD 20852 August 10, and September 13, 2018, amendment were issued on September provided that each of the criteria in 20, 2018, as part of a combined package 8:30 a.m.–10 a.m.: Future ACRS License Condition 2.D.(13)(a) is not met to the licensee (ADAMS Accession No. Activities/Report of the Planning and for each such departure. These ML18235A029). Procedures Subcommittee and Reconciliation of ACRS Comments and exemptions are related to, and necessary Dated at Rockville, Maryland, this 25th day for the granting of License Amendment of October 2018. Recommendations (Open/Closed)—The Committee will hear discussion of the No. 142, which is being issued For the Nuclear Regulatory Commission. concurrently with this exemption. recommendations of the Planning and 3. As explained in Section 6.0 of the Jennifer L. Dixon-Herrity, Procedures Subcommittee regarding NRC staff’s Safety Evaluation (ADAMS Chief, Licensing Branch 4, Division of items proposed for consideration by the Accession No. ML18207A262), this Licensing, Siting, and Environmental Full Committee during future ACRS Analysis, Office of New Reactors. exemption meets the eligibility criteria meetings. [Note: A portion of this for categorical exclusion set forth in 10 [FR Doc. 2018–23627 Filed 10–29–18; 8:45 am] meeting may be closed pursuant to 5 CFR 51.22(c)(9). Therefore, pursuant to BILLING CODE 7590–01–P U.S.C. 552b (c)(2) and (6) to discuss 10 CFR 51.22(b), no environmental organizational and personnel matters impact statement or environmental that relate solely to internal personnel NUCLEAR REGULATORY assessment needs to be prepared in rules and practices of the ACRS, and COMMISSION connection with the issuance of the information the release of which would exemption. Revised 658th Meeting of the Advisory constitute a clearly unwarranted 4. This exemption is effective as of the Committee on Reactor Safeguards invasion of personal privacy]. date of its issuance. (ACRS) 10:15 a.m.–12 p.m.: Preparation of ACRS Reports (Open)—The Committee III. License Amendment Request In accordance with the purposes of will continue its discussion of proposed By letter dated December 21, 2017 Sections 29 and 182b of the Atomic ACRS reports. (ADAMS Accession No. ML17355A416), Energy Act (42 U.S.C. 2039, 2232b), the 1 p.m.–6 p.m.: Preparation of ACRS SNC requested that the NRC amend the Advisory Committee on Reactor Reports (Open)—The Committee will COLs for VEGP, Units 3 and 4, COLs Safeguards (ACRS) will hold meetings continue its discussion of proposed NPF–91 and NPF–92. The proposed on November 1–3, 2018, Three White ACRS reports and retreat items. amendment is described in Section I of Flint North, 11601 Landsdown Street, Saturday, November 3, 2018, this Federal Register notice. North Bethesda, MD 20852. The Comission has determined for Conference Room 1C3 & 1C5, Three these amendments that the application Thursday, November 1, 2018, White Flint North, 11601 Landsdown complies with the standards and Conference Room 1C3 & 1C5, Three Street, North Bethesda, MD 20852 requirements of the Atomic Energy Act White Flint North, 11601 Landsdown 8:30 p.m.–12 p.m.: Preparation of of 1954, as amended (the Act), and the Street, North Bethesda, MD 20852 ACRS Reports (Open)—The Committee Commission’s rules and regulations. 8:30 a.m.–8:35 a.m.: Opening will continue its discussion of proposed The Commission has made appropriate Remarks by the ACRS Chairman ACRS reports and retreat items.

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Procedures for the conduct of and the meeting to ensure the availability of provided below. In addition, please be participation in ACRS meetings were this service. Individuals or aware that the Council asks that oral published in the Federal Register on organizations requesting this service testimony at the meeting be limited to October 4, 2017 (82 FR 46312). In will be responsible for telephone line 5 minutes per speaker. accordance with those procedures, oral charges and for providing the DATES: Tuesday, November 13, 2018, at or written views may be presented by equipment and facilities that they use to 1:00 p.m. members of the public, including establish the video teleconferencing ADDRESSES: Office of Personnel representatives of the nuclear industry. link. The availability of video Management, 1900 E Street NW, Room Persons desiring to make oral statements teleconferencing services is not 1350, Washington, DC 20415. should notify Quynh Nguyen, Cognizant guaranteed. FOR FURTHER INFORMATION CONTACT: ACRS Staff (Telephone: 301–415–5844, Note: The ‘‘Waterford Steam Electric Email: [email protected]), 5 days Brenda L. Roberts, Deputy Associate Station, Unit 3 License Renewal Director, Pay and Leave, Office of before the meeting, if possible, so that Application’’ meeting was listed on the appropriate arrangements can be made previous notice as ending at 10 a.m. but is Personnel Management, 1900 E Street to allow necessary time during the currently scheduled to end at 10:30 a.m. NW, Room 7H31, Washington, DC meeting for such statements. In view of 20415–8200. Phone (202) 606–2838; the possibility that the schedule for Dated: October 24, 2018. FAX (202) 606–0824; or email at pay- ACRS meetings may be adjusted by the Russell E. Chazell, [email protected]. Chairman as necessary to facilitate the Federal Advisory Committee Management For The President’s Pay Agent. conduct of the meeting, persons Officer, Office of the Secretary. Alexys Stanley, planning to attend should check with [FR Doc. 2018–23619 Filed 10–29–18; 8:45 am] Regulatory Affairs Analyst. the Cognizant ACRS staff if such BILLING CODE 7590–01–P [FR Doc. 2018–23630 Filed 10–29–18; 8:45 am] rescheduling would result in major inconvenience. The bridgeline number BILLING CODE 6329–39–P for the meeting is 866–822–3032, OFFICE OF PERSONNEL passcode 8272423#. MANAGEMENT Thirty-five hard copies of each SECURITIES AND EXCHANGE presentation or handout should be Federal Salary Council; Meeting Notice COMMISSION provided 30 minutes before the meeting. AGENCY: Office of Personnel [Release No. 34–84481; File No. SR– In addition, one electronic copy of each CboeEDGX–2018–037] presentation should be emailed to the Management. Cognizant ACRS Staff one day before ACTION: Notice of meeting. Self-Regulatory Organizations; Cboe meeting. If an electronic copy cannot be EDGX Exchange, Inc.; Notice of Filing SUMMARY: The Federal Salary Council provided within this timeframe, of a Proposed Rule Change To Permit will meet on Tuesday, November 13, presenters should provide the Cognizant the Listing and Trading of P.M.-Settled 2018, at the time and location shown ACRS Staff with a CD containing each Series on Certain Broad-Based Index below. The Council is an advisory body presentation at least 30 minutes before Options on a Pilot Basis the meeting. composed of representatives of Federal In accordance with Subsection 10(d) employee organizations and experts in October 24, 2018. of Public Law 92–463 and 5 U.S.C. the fields of labor relations and pay Pursuant to Section 19(b)(1) of the 552b(c), certain portions of this meeting policy. The Council makes Securities Exchange Act of 1934 (the may be closed, as specifically noted recommendations to the President’s Pay ‘‘Act’’),1 and Rule 19b-4 thereunder,2 above. Use of still, motion picture, and Agent (the Secretary of Labor and the notice is hereby given that on October television cameras during the meeting Directors of the Office of Management 11, 2018, Cboe EDGX Exchange, Inc. may be limited to selected portions of and Budget and the Office of Personnel filed with the Securities and Exchange the meeting as determined by the Management) about the locality pay Commission (the ‘‘Commission’’ or Chairman. Electronic recordings will be program for General Schedule ‘‘SEC’’) the proposed rule change as permitted only during the open portions employees. The Council’s described in Items I, II, and III below, of the meeting. recommendations cover the which Items have been prepared by the ACRS meeting agendas, meeting establishment or modification of locality Exchange. The Commission is transcripts, and letter reports are pay areas, the coverage of salary publishing this notice to solicit available through the NRC Public surveys, the process of comparing comments on the proposed rule change Document Room at pdr.resource@ Federal and non-Federal rates of pay, from interested persons. nrc.gov, or by calling the PDR at 1–800– and the level of comparability payments 397–4209, or from the Publicly that should be paid. I. Self-Regulatory Organization’s Available Records System (PARS) The Council will hear public Statement of the Terms of Substance of component of NRC’s document system testimony about the locality pay the Proposed Rule Change (ADAMS) which is accessible from the program, review the results of pay Cboe EDGX Exchange, Inc. (the NRC website at http://www.nrc.gov/ comparisons, and formulate its ‘‘Exchange’’ or ‘‘EDGX Options’’) reading-rm/adams.html or http:// recommendations to the President’s Pay proposes to permit the listing and www.nrc.gov/reading-rm/doc- Agent on pay comparison methods, trading of P.M.-settled series on certain collections/#ACRS/. locality pay rates, and locality pay areas broad-based index options on a pilot Video teleconferencing service is and boundaries for 2020. basis. [The text of the proposed rule available for observing open sessions of The meeting is open to the public. change is provided below.] [sic] ACRS meetings. Those wishing to use Individuals who wish to provide The text of the proposed rule change this service should contact Mr. Theron testimony or present material at the is also available on the Exchange’s Brown, ACRS Audio Visual Technician meeting should contact the Office of (301–415–6702), between 7:30 a.m. and Personnel Management using the 1 15 U.S.C. 78s(b)(1). 3:45 p.m. (ET), at least 10 days before telephone number or email address 2 17 CFR 240.19b–4.

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website (http://www.cboe.com/ permitting the trading of XSP options on risky switchover for liquidity providers. AboutCBOE/ a P.M.-settled basis will encourage As a result, without closing expiring CBOELegalRegulatoryHome.aspx), at greater trading in XSP options. contracts at 4:00 p.m., it is foreseeable the Exchange’s Office of the Secretary, Other than settlement and closing that Market-Makers could react by and at the Commission’s Public time on the last trading day (as widening spreads in order to Reference Room. discussed below), contract terms for compensate for the additional risk. P.M.-settled XSP options will be the Therefore, the Exchange believes that, in II. Self-Regulatory Organization’s same as the A.M.-settled XSP options. order to mitigate potential investor Statement of the Purpose of, and The proposed contract would use a $100 confusion and the potential for Statutory Basis for, the Proposed Rule multiplier. The minimum trading increased costs to investors, it is Change increments, strike price intervals, and appropriate to cease trading in the In its filing with the Commission, the expirations would be the same as the expiring P.M.-settled XSP contracts at Exchange included statements A.M.-settled XSP option series. P.M.- 4:00 p.m. The Exchange does not concerning the purpose of and basis for settled XSP options would have believe the proposed change will impact the proposed rule change and discussed European-style exercise. The Exchange volatility on the underlying cash market any comments it received on the will also have flexibility to open for at the close on third Fridays. Further, proposed rule change. The text of these trading additional series in response to other options exchanges close trading in statements may be examined at the customer demand. certain options on the last trading day places specified in Item IV below. The The proposed rule change amends for certain classes.4 Exchange has prepared summaries, set Rule 29.10(a) to state that, on their last If the Exchange were to propose an forth in sections A, B, and C below, of trading day, transactions in P.M.-settled extension of the XSPPM Pilot Program the most significant aspects of such XSP options may be effected on the or should the Exchange propose to make statements. Exchange between the hours of 9:30 the XSPPM Pilot Program permanent, a.m. and 4:00 p.m. Eastern time (as the Exchange would submit a filing A. Self-Regulatory Organization’s opposed to the normal trading hours for Statement of the Purpose of, and the proposing such amendments to the non-expiring P.M.-settled XSP options, XSPPM Pilot Program. Further, any Statutory Basis for, the Proposed Rule which are from 9:30 a.m. to 4:15 p.m. Change positions established under the XSPPM Eastern time). XSP options are typically Pilot Program would not be impacted by 1. Purpose priced in the market based on the expiration of the XSPPM Pilot corresponding futures values. The The proposed rule change permits the Program. For example, if the Exchange primary listing markets for the listing and trading of P.M.-settled series lists a P.M.-settled XSP option that component securities that comprise the on certain broad-based index options on expires after the XSPPM Pilot Program S&P 500 Index close trading in those a pilot basis.3 First, the proposed rule expires (and is not extended), then those securities at 4:00 p.m. The primary change would permit the listing and positions would continue to exist. If the listing exchanges for the component trading of XSP options with third- pilot were not extended, then the securities disseminate closing prices of positions could continue to exist. Friday-of-the-month expiration dates, the component securities, which are However, any further trading in those whose exercise settlement value will be used to calculate the exercise settlement series would be restricted to based on the closing index value on the value of the S&P 500 Index. The expiration day (‘‘P.M.-settled’’) for an Exchange believes that, under normal transactions where at least one side of initial period of twelve months (the trading circumstances, the primary the trade is a closing transaction. ‘‘XSPPM Pilot Program’’) from the date listing markets have sufficient As part of the XSPPM Pilot Program, of approval of this proposed rule bandwidth to prevent any data queuing the Exchange will submit a pilot report change. Second, the proposed rule that would cause any trades that are to the Commission at least two months change would permit the listing and executed prior to the closing time from prior to the expiration date of the pilot. trading of P.M.-settled options on broad- being reported after 4:00 p.m. Despite This annual report will contain an based indexes with weekly expirations the fact that the exercise settlement analysis of volume, open interest, and (‘‘Weeklys’’) and end-of-month value will be fixed at or soon after 4:00 trading patterns. The analysis would expirations (‘‘EOMs’’) for an initial p.m., if the Exchange did not close examine trading in the proposed option period of 12 months (the ‘‘Nonstandard trading in expiring P.M.-settled XSP product as well as trading in the Expirations Pilot Program’’) from the options at 4:00 p.m. on their last trading securities that comprise the S&P 500 date of approval of this proposed rule day, trading in expiring P.M.-settled Index. In addition, for series that exceed change. XSP options would continue for an certain minimum open interest parameters, the annual report will XSPPM Pilot Program additional fifteen minutes until 4:15 p.m. and would not be able to be priced provide analysis of index price volatility Proposed Rule 29.11(a)(6) permits the on corresponding futures values, but and, if needed, share trading activity. listing and trading, in addition to A.M.- rather the known cash value. At the The annual report will contain the settled XSP options, of P.M.-settled XSP same time, the prices of non-expiring following volume and open interest options with third-Friday-of-the-month P.M.-settled XSP option series would data: expiration dates on a pilot basis for an continue to move and be priced in (1) Monthly volume aggregated for all initial period of 12 months from the response to changes in corresponding trades; date of approval of this proposed rule futures prices. (2) monthly volume aggregated by change. XSP options are A.M.-settled A potential pricing divergence could expiration date; pursuant to the generic listing criteria in occur between 4:00 p.m. and 4:15 p.m. Rule 29.11(a)(5). The Exchange believes on the final trading day in expiring 4 See Cboe Options Rule 24.6, Interpretations and P.M.-settled XSP options (e.g. switch Policies .01 (options with Quarterly Index 3 The Exchange is authorized to list for trading Expirations), .03 (Cboe S&P 500 A.M./P.M. Basis options that overlie the Mini-SPX Index (‘‘XSP’’) from pricing off of futures to cash). options), .04 (P.M.-settled SPX options with third and the Russell 2000 Index (‘‘RUT’’). See Rule Further, the switch from pricing off of Friday-of-the-month expiration and P.M.-settled 29.11(a). futures to cash can be a difficult and XSP options), and .05 (MSCI EAFE Index options).

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(3) monthly volume for each determine whether the XSPPM Pilot date. If the last trading day of a month individual series; Program is consistent with the Exchange is a Monday, Wednesday, or Friday and (4) month-end open interest Act. The Exchange will make public all the Exchange lists EOMs and Weeklys, aggregated for all series; data and analyses it submits to the as applicable, in a given class, the (5) month-end open interest Commission under the XSPPM Pilot Exchange will list an EOM instead of a aggregated by expiration date; and Program. Weekly in the given class. Other (6) month-end open interest for each Other exchanges currently have pilots expirations in the same class are not individual series. that permit P.M.-settled index options.5 counted as part of the maximum The annual report will also contain Nonstandard Expirations Pilot Program number of Weeklys for a broad-based the information noted above for index class. If the Exchange is not open expiration Friday A.M.-settled XSP The proposed rule change permits the for business on a respective Monday, option series, if applicable, for the listing and trading, on a pilot basis, of the normally Monday expiring Weeklys period covered in the annual report. In P.M.-settled options on broad-based would expire on the following business addition to the annual report, the indexes with nonstandard expiration day. If the Exchange is not open for Exchange will provide the Commission dates for an initial period of 12 months business on a respective Wednesday or with interim reports of the information from the date of approval of this Friday, the normally Wednesday or listed in (1) through (6) above. proposed rule change. The Nonstandard Friday expiring Weekly will expire on In the annual report, the annual report Expirations Pilot Program will permit the previous business day. would contain the following analysis of both Weeklys and EOMs as discussed Proposed Rule 29.11(a)(2) [sic] trading patterns in expiration Friday, below. Contract terms for the Weekly permits the Exchange to open for P.M.-settled XSP option series in the and EOM expirations will be similar to trading EOMs on any broad-based index XSPPM Pilot Program: those of the A.M.-settled broad-based eligible for standard options trading to (1) A time series analysis of open index options, except that the Weekly expire on the last trading day of the interest; and and EOM expirations will be P.M.- month. EOMs will be subject to all (2) an analysis of the distribution of settled. trade sizes. provisions of Rule 29.11 and treated the Proposed Rule 29.11(j)(1) permits the same as options on the same underlying Also, for series that exceed certain Exchange to open for trading Weeklys minimum parameters, the annual report index that expire on the third Friday of on any broad-based index eligible for the expiration month. However, EOMs will also contain the following analysis standard options trading to expire on related to index price changes and, if will be P.M.-settled, and new series of any Monday, Wednesday, or Friday EOMs may be added up to and needed, underlying share trading (other than the third Friday-of-the- volume at the close on expiration including on the expiration date for an month or days that coincide with an expiring EOM. Fridays: EOM). Weeklys will be subject to all The maximum number of expirations (1) A comparison of index price provisions of Rule 29.11 and will be that may be listed for EOMs in a given changes at the close of trading on a treated the same as options on the same class is the same as the maximum given expiration Friday with underlying index that expire on the number of expirations permitted in Rule comparable price changes from a control third Friday of the expiration month. 29.11(a)(3) for standard options on the sample. The data will include a However, Weeklys will be P.M.-settled, same broad-based index.7 EOMs need calculation of percentage price changes and new Weekly series may be added not be for consecutive end-of-month for various time intervals and compare up to and including on the expiration expirations. However, the expiration that information to the respective date for an expiring Weekly. control sample. Raw percentage price The maximum number of expirations date of a non-consecutive expiration change data as well as percentage price that may be listed for each Weekly (i.e., may not be beyond what would be change data normalized for prevailing a Monday expiration, a Wednesday considered the last expiration date if the market volatility, as measured by an expiration, or Friday expiration, as maximum number of expirations were appropriate index as agreed by the applicable) in a given class will be the listed consecutively. EOMs that are first Commission and the Exchange, would same as the maximum number of listed in a given class may expire up to be provided; and expirations permitted in Rule four weeks from the actual listing date. (2) a calculation of share volume for 29.11(a)(3) for standard options on the Other expirations in the same class are a sample set of the component securities same broad-based index.6 Weeklys not counted as part of the maximum representing an upper limit on share would not need to be for consecutive number of EOMs for a broad-based trading that could be attributable to Monday, Wednesday, or Friday index class. expiring in-the-money series. The data, expirations, as applicable. However, the The proposed rule change amends if needed, will include a comparison of expiration date of a non-consecutive Rule 29.11(c)(5)(C) to provide that the the calculated share volume for expiration would not be permitted lowest strike interval for series of XSP securities in the sample set to the beyond what would be considered the options listed under the Nonstandard average daily trading volumes of those last expiration date if the maximum Expirations Pilot Program will be $0.50. securities over a sample period. number of expirations were listed With respect to XSP, this is consistent The minimum open interest consecutively. Weeklys that are first with the minimum strike interval for parameters, control sample, time listed in a given class could expire up XSP options listed under the Short 8 intervals, method for randomly selecting to four weeks from the actual listing Term Series Program. Additionally, the component securities, and sample this is consistent with the minimum periods would be determined by the 5 See Cboe Options Rule 24.9, Interpretation and strike interval for options on the Exchange and the Commission. Policy .14 and Phlx Rule 1101A, Commentary .05. Standard & Poor’s Depository Receipts Additionally, the Exchange will 6 Pursuant to Rule 29.11(a)(3), the Exchange may Trust (SPY), which is an ETF that like provide the Commission with any list up to six expiration months at any one time. XSP tracks the performance of 1/10th Therefore, pursuant to the proposed rule change, additional data or analyses the the Exchange may list a maximum of six Weekly Commission requests because it deems expirations under the Nonstandard Expirations 7 Id. such data or analyses necessary to Pilot Program. 8 See Rule 29.11(c)(5)(C).

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the value of the S&P 500 Index, with the expiration date of the pilot (the exchanges accompanied by rising open weekly expirations.9 ‘‘annual report’’). The annual report will interest in Weekly and EOM series Weeklys and EOMs will be subject to contain an analysis of volume, open would suggest that users are shifting the same rules that currently govern the interest, and trading patterns. In positions. trading of standard monthly broad- addition, for series that exceed certain For each Weekly and EOM expiration based index options, including sales minimum open interest parameters, the that has open interest that exceeds practice rules, margin requirements, and annual report will provide analysis of certain minimum thresholds, the annual floor trading procedures. Contract terms the index price volatility, and, if report will contain the following for Weeklys and EOMs will be the same needed, share trading activity. analysis related to index price changes as those for standard monthly broad- For all Weekly and EOM series, the and, if needed, underlying share trading based index options. Since Weeklys and annual report will contain the following volume at the close on expiration dates: EOMs will be new types of series, and volume and open interest data for each (1) A comparison of index price not a new class, the Exchange proposes broad-based index overlying Weekly changes at the close of trading on a that Weeklys and EOMs will be and EOM options: given expiration date with comparable aggregated for any applicable reporting (1) Monthly volume aggregated for all price changes from a control sample. and other requirements.10 Pursuant to Weekly and EOM series; The data will include a calculation of new proposed Rule 29.11(j)(4), expiring (2) Volume in Weekly and EOM series percentage price changes for various transactions in Weeklys and EOMs may aggregated by expiration date; time intervals and compare that be effected on the Exchange between the (3) Month-end open interest information to the respective control hours of 9:30 a.m. and 4:00 p.m. aggregated for all Weekly and EOM sample. Raw percentage price change (Eastern time). series; data as well as percentage price change As stated above, this proposed rule (4) Month-end open interest for EOM data normalized for prevailing market change establishes a Nonstandard series aggregated by expiration date and volatility, as measured by an Expirations Pilot Program for broad- open interest for Weekly series appropriate index agreed to by the based index options on a pilot basis, for aggregated by expiration date; Commission and the Exchange, will be an initial period of 12 months from the (5) Ratio of monthly aggregate volume provided; and date of approval of this proposed rule in Weekly and EOM series to total (2) If needed, a calculation of share change. If the Exchange were to propose monthly class volume; and volume for a sample set of the an extension of the Nonstandard (6) Ratio of month-end open interest component securities representing an Expirations Pilot Program or should the in EOM series to total month-end class upper limit on share trading that could Exchange propose to make it permanent, open interest and ratio of open interest be attributable to expiring in-the-money the Exchange would submit a filing in each Weekly series to total class open Weekly and EOM series. The data, if proposing such amendments. Further, interest. needed, will include a comparison of any positions established under the In addition, the annual report will the calculated share volume for Nonstandard Expirations Pilot Program contain the information noted above for securities in the sample set to the would not be impacted by the standard expiration Friday, A.M.-settled average daily trading volumes of those expiration of the pilot. For example, if series, if applicable, for the period securities over a sample period. the Exchange lists a Weekly or EOM that covered in the annual report as well as The minimum open interest expires after the Nonstandard for the six-month period prior to the parameters, control sample, time Expirations Pilot Program expires (and initiation of the pilot. intervals, method for selecting the is not extended), then those positions Upon request by the SEC, the component securities, and sample would continue to exist. However, any Exchange will provide a data file periods will be determined by the further trading in those series would be containing: (1) Weekly and EOM option Exchange and the Commission. restricted to transactions where at least volume data aggregated by series, and Additionally, the Exchange will one side of the trade is a closing (2) Weekly open interest for each provide the Commission with any transaction. expiring series and EOM month-end additional data or analyses the As part of the Nonstandard open interest for expiring series. Commission requests because it deems Expirations Pilot Program, the Exchange In the annual report, the Exchange such data or analyses necessary to will submit a pilot report to the also proposes to identify Weekly and determine whether the Nonstandard Commission at least two months prior to EOM trading patterns by undertaking a Expirations Pilot Program is consistent time series analysis of open interest in with the Exchange Act. The Exchange 9 See Rule 19.6, Interpretation and Policy .05(f). Weekly and EOM series aggregated by will make public all data and analyses 10 Rule 29.5(a) requires Options Members to expiration date compared to open it submits to the Commission under the comply with the applicable rules of Cboe Options interest in near-term standard expiration Nonstandard Expirations Pilot Program. with respect to position limits for broad-based index options for options traded on Cboe Options. Friday A.M.-settled series in order to Other exchanges currently have pilots Cboe Options Rule 24.4, Interpretation and Policy determine whether users are shifting that have weekly and end-of-month .03 sets forth the reporting requirements for certain positions from standard series to expirations.11 market indexes that do not have position limits, Weekly and EOM series. In addition, to including XSP and RUT, and would apply to XSP Additional Information and RUT options traded on the Exchange pursuant the extent that data on other weekly or to Rule 29.5(a); see also Cboe Options Rule 24.4(b), monthly P.M.-settled products from Precedent exists for P.M.-settled which provides that Weeklys and EOMs will be other exchanges is publicly available, broad-based index options, as other aggregated with option contracts on the same broad- the report will also compare open options exchanges list P.M.-settled based index and will be subject to the overall 12 position limit, and would apply to Weeklys/EOMs interest with these options in order to broad-based index options. The traded on the Exchange pursuant to Rule 29.5(a). determine whether users are shifting The Exchange notes that the proposed aggregation positions from other weekly or monthly 11 See Cboe Options Rule 24.9(e); and Phlx Rule is consistent with the aggregation requirements or P.M.-settled products to the Weekly and 1101A(b)(vii). 12 other types of option series (e.g. quarterly expiring EOM series. Declining open interest in See, e.g., Cboe Options Rule 24.9(a)(4) (OEX not options) that may be listed on the Exchange and listed as A.M.-settled) and Interpretation and Policy that do not expire on the customary ‘‘third Friday’’ standard series or the weekly or .14 (permits listing of P.M.-settled SPX and XSP (see Cboe Options Rule 24.4(e)). monthly P.M.-settled products of other Continued

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Exchange does not believe that any indexes. A list of identifying current ISG position limits on RUT and XSP market disruptions will be encountered members is available at https:// options.14 Therefore, there will be no with the introduction of listing P.M.- www.isgportal.org/isgPortal/public/ position limits on P.M.-settled RUT and settled options on the Exchange. The members.htm. XSP options. P.M.-settled XSP options Exchange will monitor for any such The Exchange has analyzed its and Weekly/EOM broad-based index disruptions or the development of any capacity and represents that it believes options are currently authorized for factors that would cause such the Exchange and OPRA have the listing on Cboe Options,15 and thus the disruptions. necessary systems capacity to handle same margin requirements and position The Exchange notes that P.M.-settled the additional traffic associated with the and exercise limits that apply to these options predominate in the over-the- listing of P.M.-settled XSP and Weekly/ products as listed and traded on Cboe counter (‘‘OTC’’) market, and the EOM option series up to the proposed Options will apply to these products Exchange is not aware of any adverse number of possible expirations and when listed and traded on the effects in the stock market attributable strike prices. The Exchange believes any Exchange. The proposed rule change to the P.M.-settlement feature. The additional traffic that would be will also result in similar regulatory Exchange is merely proposing to offer a generated from the introduction of P.M.- treatment for similar option products. P.M.-settled product in an exchange settled XSP and Weekly/EOM options environment that offers the benefit of series will be manageable. The 2. Statutory Basis added transparency, price discovery, Exchange believes its Members will not The Exchange believes the proposed and stability. In response to any have a capacity issue as a result of this rule change is consistent with the potential concerns that disruptive proposed rule change. The Exchange Securities Exchange Act of 1934 (the trading conduct could occur as a result also represents that it does not believe ‘‘Act’’) and the rules and regulations of the concurrent listing and trading of this expansion will cause fragmentation thereunder applicable to the Exchange two index option products based on the of liquidity. The Exchange will monitor and, in particular, the requirements of same index but for which different the trading volume associated with the Section 6(b) of the Act.16 Specifically, settlement methodologies exist (i.e., one additional options series listed as a the Exchange believes the proposed rule is A.M.-settled and one is P.M.-settled), result of this proposed rule change and change is consistent with the Section the Exchange notes that Cboe Options the effect (if any) of these additional 6(b)(5) 17 requirements that the rules of lists and trades both A.M.-settled and series on market fragmentation and on an exchange be designed to prevent P.M.-settled SPX options, and Phlx lists the capacity of the Exchange’s fraudulent and manipulative acts and and trades both A.M.-settled and P.M.- automated systems. practices, to promote just and equitable settled NDX options. The Exchange is P.M.-settled options would be subject principles of trade, to foster cooperation not aware of any market disruptions to all provisions of Rule 29.11. P.M.- and coordination with persons engaged occurring as a result of these exchanges settled options would be subject to the in regulating, clearing, settling, offering both products. same rules that govern the trading of processing information with respect to, The adoption of P.M.-settled options A.M.-settled options overlying the same and facilitating transactions in on an exchange that lists A.M.-settled indexes, including sales practice rules, securities, to remove impediments to options in the same class would provide margin requirements, and floor trading and perfect the mechanism of a free and greater spread opportunities. This procedures. P.M.-settled options will be open market and a national market manner of trading in different products subject to the margin requirements set system, and, in general, to protect allows a market participant to take forth in Chapter 28 and the position investors and the public interest. advantage of the different expiration limits set forth in Rule 29.5. Chapter 28 The Exchange believes the proposed times, providing expanded trading imposes the margin requirements of rule change will attract order flow to the opportunities. In the options market either Cboe Options or the New York Exchange, increase the variety of listed currently, market participants regularly Stock Exchange on Exchange Options options to investors, and provide a trade similar or related products in Members. Similarly, Rule 29.5 imposes valuable hedge tool to investors. The conjunction with each other, which position (and exercise) limits for broad- Exchange believes the proposed rule contributes to overall market liquidity. based index options of Cboe Options on change will also remove impediments to The Exchange represents it has an Exchange Options Members. Since P.M.- and perfect the mechanism of a free and adequate surveillance program in place settled options will be a new type of open market, and in general protect for index options. The Exchange is a series, and not a new class, the investors by expanding the ability of member of the Intermarket Surveillance Exchange proposes that the P.M.-settled investors to hedge risks against market Group (‘‘ISG’’), which is comprised of options will be aggregated for any movements stemming from economic an international group of exchanges, applicable reporting and other releases or market events that occur market centers, and market regulators. requirements.13 Currently, there are no during the month and at the end of the The purpose of ISG is to provide a month. Accordingly, the Exchange framework for the sharing of 13 See Rule 29.5(a), which requires Options believes that P.M.-settled options will information and the coordination of Members to comply with the applicable rules of create greater trading and hedging Cboe Options with respect to position limits for opportunities and flexibility, and regulatory efforts among exchanges broad-based index options for options traded on trading securities and related products Cboe Options. Cboe Options Rule 24.4(b), which to address potential intermarket applies to index options traded on the Exchange are listed on the Exchange and that do not expire on the customary ‘‘third Friday.’’ See Cboe Options manipulations and trading abuses. ISG pursuant to Rule 29.5(a), provides that Nonstandard Expirations will be aggregated with option contracts Rule 24.4 (which applies to the Exchange pursuant plays a crucial role in information on the same broad-based index and subject to the to Rule 29.5(a)). 14 sharing among markets that trade overall position limit. Additionally, Cboe Options See Cboe Options Rule 24.4(a) (which applies securities, options on securities, Rule 24.4(d), which applies to index options traded to the Exchange pursuant to Rule 29.5(a)). 15 security futures products, and futures on the Exchange pursuant to Rule 29.5(a), positions Similarly, pursuant to Cboe Options Chapter in reduced-value index options will be aggregated 12, Cboe Options Trading Permit Holders may and options on broad-based security with positions in full-value indices. The Exchange request to have New York Stock Exchange margin notes that the proposed aggregation is consistent requirements apply to their trading. options); and PHLX Rule 1101A, Commentary .05 with the aggregation requirements for other types of 16 15 U.S.C. 78f(b). (permits listing of P.M.-settled NDX options). option series (e.g. quarterly expiring options) that 17 15 U.S.C. 78f(b)(5).

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provide customers with the ability to participants with an alternative to help of the purposes of the Act. P.M.-settled more closely tailor their investment offset market-on-close imbalances.19 options would be available for trading objectives. Other exchanges currently have pilots on the Exchange to all market The Commission has previously that permit P.M.-settled index options 20 participants. The Exchange believes the stated that when cash-settled index and Weekly/EOM options.21 proposed rule change will increase the options were first introduced in the The proposed rule change to permit variety of listed options to investors, 1980s, they generally utilized closing- transactions on the Exchange in P.M.- and provide valuable hedge tools to price settlement procedures (i.e., P.M. settled XSP and Weekly/EOM options investors. The listing of P.M.-settled settlement). The Commission stated it on their last trading day between the options will enhance competition by became concerned about the impact of hours of 9:30 a.m. and 4:00 p.m. Eastern providing investors with an additional P.M. settlement on cash-settled index time (as opposed to the normal trading investment vehicle, through which options on the markets for the hours for non-expiring P.M.-settled XSP investors can gain and hedge exposure underlying stocks at the close on and Weekly/EOM options, which are to the stocks that compose the expiration Fridays, especially during the from 9:30 a.m. to 4:15 p.m. Eastern time) applicable broad-based indexes. quarterly expirations of the third Friday will prevent potential pricing Additionally, markets participants are of March, June, September, and divergence that could occur between welcome to become Members and trade December when options, index futures, 4:00 p.m. and 4:15 p.m. on the final at the Exchange if they determine this and options on index futures all expire trading day in expiring P.M.-settled XSP proposed rule change has made the simultaneously. The Commission options. Without closing expiring Exchange more attractive or favorable. expressed concerns that P.M. settlement contracts at 4:00 p.m., it is foreseeable Further, this product could offer a was believed to have contributed to that Market-Makers would react by competitive alternative to other existing above-average volume and added widening spreads in order to investment products that seek to allow market volatility on those days, which compensate for the additional risk. Members to gain broad market exposure. sometimes led to sharp price Therefore, the Exchange believes that, in Finally, all options exchanges are free to movements during the last hour of order to mitigate potential investor compete by listing and trading index trading, as a consequence of which the confusion and the potential for options that are P.M.-settled. Other close of trading on the quarterly increased costs to investors, it is exchanges currently have pilots that expiration Friday became known as the appropriate to cease trading in the permit P.M.-settled index options 23 or ‘‘triple witching hour.’’ The expiring P.M.-settled XSP and Weekly/ Weeklys/EOMs.24 Commission observed that besides EOM contracts at 4:00 p.m. The The proposed rule change to permit contributing to investor anxiety, Exchange does not believe the proposed transactions on the Exchange in P.M.- heightened volatility during the change will impact volatility on the settled XSP and Weekly/EOM options expiration periods created the underlying cash market at the close on on their last trading day between the opportunity for manipulation and other third Fridays. Further, the other options hours of 9:30 a.m. and 4:00 p.m. Eastern abusive trading practices in anticipation exchanges close trading in certain time (as opposed to the normal trading of the liquidity constraints.18 options on the last trading day for hours for non-expiring P.M.-settled XSP However, the Exchange believes that certain classes.22 and Weekly/EOM options, which are the above concerns that have led to the The Exchange has analyzed its from 9:30 a.m. to 4:15 p.m. Eastern time) transition to A.M. settlement for index capacity and represents that it believes will prevent potential pricing derivatives have been largely mitigated. the Exchange and OPRA have the divergence that could occur between It believes that expiration pressure in necessary systems capacity to handle 4:00 p.m. and 4:15 p.m. on the final the underlying cash markets at the close the additional traffic associated with the trading day in expiring P.M.-settled XSP has been greatly reduced with the listing of P.M.-settled options. The and Weekly/EOM options. Without advent of multiple primary listing and Exchange believes any additional traffic closing expiring contracts at 4:00 p.m., unlisted trading privilege markets, and that may be generated from the it is foreseeable that Market-Makers that trading is now widely dispersed introduction of P.M.-settled options will would react by widening spreads in among many market centers. be manageable. The Exchange order to compensate for the additional Additionally, the Exchange notes that represents that it has in place adequate risk. Therefore, the Exchange believes opening procedures in the 1990s were surveillance procedures to monitor that, in order to mitigate potential deemed acceptable to mitigate one-sided trading in these options thereby helping investor confusion and the potential for order flow driven by index option to ensure the maintenance of a fair and increased costs to investors, it is expiration and that the New York Stock orderly market. appropriate to cease trading in the Exchange and Nasdaq Stock Market, B. Self-Regulatory Organization’s expiring P.M.-settled XSP and Weekly/ LLC each use an automated closing Statement on Burden on Competition EOM contracts at 4:00 p.m. The cross procedures and has a closing order Exchange does not believe the proposed type that facilitates orderly closings. The Exchange does not believe that change will impact volatility on the These closing procedures on the the proposed rule change will impose underlying cash market at the close on exchanges on which the components of any burden on competition that is not third Fridays. Further, the other options necessary or appropriate in furtherance the S&P 500 Index trade are well- exchanges close trading in certain equipped to mitigate imbalance pressure options on the last trading day for 19 See id. at the close. In addition, after-hours 25 20 See Cboe Options Rule 24.9, Interpretation and certain classes. trading now provides market Policy .14; and Phlx Rule 1101A, Commentary .05. 21 See Cboe Options Rule 24.9(e); and Phlx Rule 23 See Cboe Options Rule 24.9, Interpretation and 18 See Securities Exchange Act Release No. 65256 1101A(b)(vii). Policy .14 and Phlx Rule 1101A, Interpretation and (September 2, 2011), 76 FR 55569 (September 9, 22 See Cboe Options Rule 24.6, Interpretations Policy .05. 2011) (SR–C2–2011–008) (order approving listing of and Policies .01 (options with Quarterly Index 24 See Cboe Options Rule 24.9(e); and Phlx Rule SPXPM options on C2); see also Securities Expirations), .03 (Cboe S&P 500 a.m./PM Basis 1101A(b)(vii). Exchange Act Release No. 81293 (August 2, 2017), options), .04 (P.M.-settled SPX options with third 25 See Cboe Options Rule 24.6, Interpretations 82 FR 151 (August 8, 2017) (SR–Phlx–2017–04) (or Friday-of-the-month expiration and P.M.-settled and Policies .01 (options with Quarterly Index approving listing of NDXPM options on Phlx). XSP options), and .05 (MSCI EAFE Index options). Continued

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The Exchange believes that the rules/sro.shtml). Copies of the (a)(5), (a)(6), (a)(7), (a)(8), (a)(9)(ii) and proposed rule change will relieve any submission, all subsequent (a)(10), permit consideration of the burden on, or otherwise promote, amendments, all written statements scheduled matters at the closed meeting. competition, as the rules are with respect to the proposed rule Commissioner Peirce, as duty officer, substantially the same as those of other change that are filed with the voted to consider the items listed for the options exchanges, as noted above. Commission, and all written closed meeting in closed session. communications relating to the The subject matters of the closed C. Self-Regulatory Organization’s proposed rule change between the meeting will be: Statement on Comments on the Commission and any person, other than Institution and settlement of Proposed Rule Change Received From those that may be withheld from the injunctive actions; Members, Participants, or Others public in accordance with the Institution and settlement of The Exchange neither solicited nor provisions of 5 U.S.C. 552, will be administrative proceedings; and received comments on the proposed available for website viewing and Other matters relating to enforcement rule change. printing in the Commission’s Public proceedings. III. Date of Effectiveness of the Reference Room, 100 F Street NE, At times, changes in Commission Proposed Rule Change and Timing for Washington, DC 20549, on official priorities require alterations in the Commission Action business days between the hours of scheduling of meeting items. 10:00 a.m. and 3:00 p.m. Copies of the CONTACT PERSON FOR MORE INFORMATION: Within 45 days of the date of filing also will be available for For further information and to ascertain publication of this notice in the Federal inspection and copying at the principal what, if any, matters have been added, Register or within such longer period office of the Exchange. All comments deleted or postponed; please contact up to 90 days (i) as the Commission may received will be posted without change. Brent J. Fields from the Office of the designate if it finds such longer period Persons submitting comments are Secretary at (202) 551–5400. to be appropriate and publishes its cautioned that we do not redact or edit Dated: October 25, 2018. reasons for so finding or (ii) as to which personal identifying information from Lynn M. Powalski, the Exchange consents, the Commission comment submissions. You should will: submit only information that you wish Deputy Secretary. A. by order approve or disapprove to make available publicly. All [FR Doc. 2018–23773 Filed 10–26–18; 11:15 am] such proposed rule change, or BILLING CODE 8011–01–P B. institute proceedings to determine submissions should refer to File whether the proposed rule change Number SR–CboeEDGX–2018–037, and should be disapproved. should be submitted on or before November 20, 2018. SECURITIES AND EXCHANGE COMMISSION IV. Solicitation of Comments For the Commission, by the Division of Interested persons are invited to Trading and Markets, pursuant to delegated [Release No. 34–84476; File No. SR–BX– submit written data, views, and authority.26 2018–048] arguments concerning the foregoing, Eduardo A. Aleman, Self-Regulatory Organizations; Nasdaq including whether the proposed rule Assistant Secretary. BX, Inc.; Notice of Filing and change is consistent with the Act. [FR Doc. 2018–23625 Filed 10–29–18; 8:45 am] Immediate Effectiveness of Proposed Comments may be submitted by any of BILLING CODE 8011–01–P Rule Change To Delete the Current the following methods: Rules on Arbitration Electronic Comments SECURITIES AND EXCHANGE October 24, 2018. • Use the Commission’s internet COMMISSION Pursuant to Section 19(b)(1) of the comment form (http://www.sec.gov/ Securities Exchange Act of 1934 rules/sro.shtml); or Sunshine Act Meetings (‘‘Act’’),1 and Rule 19b–4 thereunder,2 • Send an email to rule-comments@ notice is hereby given that on October sec.gov. Please include File Number SR– TIME AND DATE: 2:00 p.m. on Thursday, 9, 2018, Nasdaq BX, Inc. (‘‘BX’’ or CboeEDGX–2018–037 on the subject November 1, 2018. ‘‘Exchange’’) filed with the Securities line. PLACE: The meeting will be held at the and Exchange Commission (‘‘SEC’’ or Paper Comments Commission’s headquarters, 100 F ‘‘Commission’’) the proposed rule Street NE, Washington, DC 20549. • Send paper comments in triplicate change as described in Items I, II, and STATUS: This meeting will be closed to III, below, which Items have been to Secretary, Securities and Exchange the public. Commission, 100 F Street NE, prepared by the Exchange. The MATTERS TO BE CONSIDERED: Washington, DC 20549–1090. Commission is publishing this notice to Commissioners, Counsel to the All submissions should refer to File solicit comments on the proposed rule Commissioners, the Secretary to the Number SR–CboeEDGX–2018–037. This change from interested persons. Commission, and recording secretaries file number should be included on the will attend the closed meeting. Certain I. Self-Regulatory Organization’s subject line if email is used. To help the staff members who have an interest in Statement of the Terms of Substance of Commission process and review your the matters also may be present. the Proposed Rule Change comments more efficiently, please use The General Counsel of the The Exchange proposes to delete the only one method. The Commission will Commission, or his designee, has current rules on arbitration (‘‘Current post all comments on the Commission’s certified that, in his opinion, one or Arbitration Rules’’), under the 10000 internet website (http://www.sec.gov/ more of the exemptions set forth in 5 Series (Rules 10001 through 10102), and U.S.C. 552b(c)(3), (5), (6), (7), (8), 9(B) incorporate by reference The Nasdaq Expirations), .03 (Cboe S&P 500 a.m./PM Basis options), .04 (P.M.-settled SPX options with third and (10) and 17 CFR 200.402(a)(3), Friday-of-the-month expiration and P.M.-settled 1 15 U.S.C. 78s(b)(1). XSP options), and .05 (MSCI EAFE Index options). 26 17 CFR 200.30–3(a)(12). 2 17 CFR 240.19b–4.

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Stock Market LLC’s (‘‘Nasdaq’’) rules on operates the largest securities dispute 2. Statutory Basis arbitration at General 6 (‘‘Proposed resolution forum in the United States,4 Arbitration Rules’’), into General 6 of and has given the Exchange access to The Exchange believes that its the Exchange’s rulebook’s (‘‘Rulebook’’) these services. Under the Current proposal is consistent with Section 6(b) shell structure.3 Arbitration Rules, Members and of the Act,9 in general, and furthers the The text of the proposed rule change associated persons of a Member are objectives of Section 6(b)(5) of the Act,10 is available on the Exchange’s website at subject to the FINRA Code of in particular, in that it is designed to http://nasdaqbx.cchwallstreet.com/, at Arbitration Procedure. promote just and equitable principles of the principal office of the Exchange, and Because the Affiliated Exchanges are trade, to remove impediments to and at the Commission’s Public Reference also parties to similar Regulatory perfect the mechanism of a free and Room. Contracts with FINRA that make their open market and a national market II. Self-Regulatory Organization’s members and associated persons of such system, and, in general to protect Statement of the Purpose of, and members subject to the FINRA Code of investors and the public interest, by Statutory Basis for, the Proposed Rule Arbitration Procedure, the Exchange promoting efficiency and structural Change believes it is pertinent that a common conformity of the Exchange’s processes set of rules on arbitration be included in In its filing with the Commission, the with those of the Affiliated Exchanges the General section of the Rulebook’s Exchange included statements and to make the Exchange’s Rulebook shell. Nasdaq completed this process concerning the purpose of and basis for easier to read and more accessible to its recently 5 and, pursuant to subsequent the proposed rule change and discussed Members. The Exchange believes that filings, the intention is to replace the any comments it received on the the adoption and harmonization of the existing arbitration rules for each of the proposed rule change. The text of these arbitration rules and cross-reference Affiliated Exchanges by incorporating statements may be examined at the updates are of a non-substantive nature. the Nasdaq rules on arbitration by places specified in Item IV below. The B. Self-Regulatory Organization’s Exchange has prepared summaries, set reference. forth in sections A, B, and C below, of Therefore, the Exchange will Statement on Burden on Competition incorporate by reference the Proposed the most significant aspects of such The Exchange does not believe that statements. Arbitration Rules in ‘‘General 6 Arbitration’’ of the shell’s ‘‘General the proposed rule change will impose A. Self-Regulatory Organization’s Equity and Options Rules’’ section. any burden on competition not Statement of the Purpose of, and The relocation and harmonization of necessary or appropriate in furtherance Statutory Basis for, the Proposed Rule the arbitration rules is part of the of the purposes of the Act. The Change Exchange’s continued effort to promote proposed changes do not impose a 1. Purpose efficiency and conformity of its burden on competition because, as processes with those of its Affiliated previously stated, they are (i) of a non- The Exchange proposes to delete the Exchanges.6 The Exchange believes that substantive nature, (ii) intended to rules on arbitration, currently under the the adoption and placement of the harmonize the structure of the 10000 Series (Rules 10001 through Proposed Arbitration Rules to their new Exchange’s rules with those of its 10102), and incorporate by reference the location in the shell will facilitate the Affiliated Exchanges, and (iii) intended Nasdaq rules on arbitration at General 6 use of the Rulebook by Members 7 of the to organize the Rulebook in a way that of Nasdaq’s rulebook into General 6 of Exchange who are members of other it will ease the Members’ navigation and the Exchange’s Rulebook. The Exchange adopted the Current Affiliated Exchanges. Moreover, the reading of the rules across the Affiliated Arbitration Rules to ensure a fair and proposed changes are of a conforming Exchanges. efficient manner in which to handle any nature and will not amend the substance of the adopted rules other C. Self-Regulatory Organization’s dispute, claim or controversy arising out Statement on Comments on the of, or in connection with, the business than to update the language to that of the Proposed Arbitration Rules, and to Proposed Rule Change Received From of any Member of the Exchange. To help Members, Participants, or Others administer the process of dispute make conforming cross-reference resolution, the Exchange and FINRA are changes. No written comments were either parties to a Regulatory Contract, BX will continue to file proposed rule solicited or received. pursuant to which FINRA has agreed to changes to amend its General 6 Rules perform certain functions and provide until such time as it receives an III. Date of Effectiveness of the access to certain services, including: exemption from the Securities and Proposed Rule Change and Timing for Member regulation and registration; Exchange Commission, pursuant to its Commission Action authority under Section 36 of the non-real time market surveillance; Because the foregoing proposed rule examinations and investigations; and Exchange Act of 1934 (‘‘Act’’) and Rule 8 change does not: (i) Significantly affect dispute resolution. FINRA currently 0–12 thereunder, from the Section 19(b) filing requirements to separately the protection of investors or the public interest; (ii) impose any significant 3 Recently, the Exchange added a shell structure file a proposed rule change to amend to its Rulebook with the purpose of improving General 6. burden on competition; and (iii) become efficiency and readability and to align its rules operative for 30 days from the date on closer to those of its five sister exchanges, The 4 http://www.finra.org/arbitration-and-mediation. which it was filed, or such shorter time Nasdaq Stock Market LLC; Nasdaq PHLX LLC; 5 Nasdaq ISE, LLC; Nasdaq GEMX, LLC; and Nasdaq See Securities Exchange Act Release No. 83834 as the Commission may designate, it has MRX, LLC (‘‘Affiliated Exchanges’’). The shell (August 13, 2018), 83 FR 41115 (August 17, 2018) become effective pursuant to Section structure currently contains eight (8) Chapters (SR–NASDAQ–2018–067). 19(b)(3)(A)(iii) of the Act 11 and which, once complete, will apply a common set of 6 See footnote 3. rules to the Affiliated Exchanges. See Securities 7 Exchange Rule 0120(i). Exchange Act Release No. 82174 (November 29, 8 See 17 CFR 240.0–12; Securities Exchange Act 9 15 U.S.C. 78f(b). 2017), 82 FR 57492 (December 5, 2017) (SR–BX– Release No. 39624 (February 5, 1998), 63 FR 8101 10 15 U.S.C. 78f(b)(5). 2017–054). (February 18, 1998). 11 15 U.S.C. 78s(b)(3)(A)(iii).

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subparagraph (f)(6) of Rule 19b–4 Reference Room, 100 F Street NE, General 6 of the Exchange’s rulebook’s thereunder.12 Washington, DC 20549, on official (‘‘Rulebook’’) shell structure.3 At any time within 60 days of the business days between the hours of 10 The text of the proposed rule change filing of the proposed rule change, the a.m. and 3 p.m. Copies of the filing also is available on the Exchange’s website at Commission summarily may will be available for inspection and http://ise.cchwallstreet.com/, at the temporarily suspend such rule change if copying at the principal office of the principal office of the Exchange, and at it appears to the Commission that such Exchange. All comments received will the Commission’s Public Reference action is necessary or appropriate in the be posted without change. Persons Room. public interest, for the protection of submitting comments are cautioned that II. Self-Regulatory Organization’s investors, or otherwise in furtherance of we do not redact or edit personal Statement of the Purpose of, and the purposes of the Act. If the identifying information from comment Statutory Basis for, the Proposed Rule Commission takes such action, the submissions. You should submit only Change Commission shall institute proceedings information that you wish to make to determine whether the proposed rule available publicly. All submissions In its filing with the Commission, the should be approved or disapproved. should refer to File Number SR–BX– Exchange included statements 2018–048 and should be submitted on concerning the purpose of and basis for IV. Solicitation of Comments or before November 20, 2018. the proposed rule change and discussed Interested persons are invited to any comments it received on the For the Commission, by the Division of proposed rule change. The text of these submit written data, views, and Trading and Markets, pursuant to delegated arguments concerning the foregoing, 13 statements may be examined at the authority. places specified in Item IV below. The including whether the proposed rule Eduardo A. Aleman, change is consistent with the Act. Exchange has prepared summaries, set Assistant Secretary. Comments may be submitted by any of forth in sections A, B, and C below, of the following methods: [FR Doc. 2018–23620 Filed 10–29–18; 8:45 am] the most significant aspects of such BILLING CODE 8011–01–P statements. Electronic Comments A. Self-Regulatory Organization’s • Use the Commission’s internet Statement of the Purpose of, and comment form (http://www.sec.gov/ SECURITIES AND EXCHANGE COMMISSION Statutory Basis for, the Proposed Rule rules/sro.shtml); or Change • Send an email to rule-comments@ sec.gov. Please include File Number SR– [Release No. 34–84478; File No. SR–ISE– 1. Purpose BX–2018–048 on the subject line. 2018–85] The Exchange proposes to delete the rules on arbitration, currently under Paper Comments Self-Regulatory Organizations; Nasdaq Chapter 18, and incorporate by • ISE, LLC; Notice of Filing and Send paper comments in triplicate reference the Nasdaq rules on Immediate Effectiveness of Proposed to Secretary, Securities and Exchange arbitration at General 6 of Nasdaq’s Rule Change To Delete Current Rules Commission, 100 F Street NE, rulebook into General 6 of the on Arbitration, under Chapter 18 Washington, DC 20549–1090. Exchange’s Rulebook. All submissions should refer to File October 24, 2018. The Exchange adopted the Current Number SR–BX–2018–048. This file Arbitration Rules to ensure a fair and Pursuant to Section 19(b)(1) of the number should be included on the efficient manner in which to handle any Securities Exchange Act of 1934 subject line if email is used. To help the dispute, claim or controversy arising out (‘‘Act’’),1 and Rule 19b–4 thereunder,2 Commission process and review your of, or in connection with, the business notice is hereby given that on October comments more efficiently, please use of any Member of the Exchange. To help 9, 2018, Nasdaq ISE, LLC (‘‘ISE’’ or only one method. The Commission will administer the process of dispute ‘‘Exchange’’) filed with the Securities post all comments on the Commission’s resolution, the Exchange and FINRA are and Exchange Commission (‘‘SEC’’ or internet website (http://www.sec.gov/ parties to a Regulatory Contract, ‘‘Commission’’) the proposed rule rules/sro.shtml). pursuant to which FINRA has agreed to change as described in Items I, II, and Copies of the submission, all perform certain functions and provide III, below, which Items have been subsequent amendments, all written access to certain services, including: prepared by the Exchange. The statements with respect to the proposed Member regulation and registration; Commission is publishing this notice to rule change that are filed with the non-real time market surveillance; solicit comments on the proposed rule Commission, and all written examinations and investigations; and change from interested persons. communications relating to the dispute resolution. FINRA currently proposed rule change between the I. Self-Regulatory Organization’s operates the largest securities dispute Commission and any person, other than Statement of the Terms of Substance of resolution forum in the United States,4 those that may be withheld from the the Proposed Rule Change and has given the Exchange access to public in accordance with the provisions of 5 U.S.C. 552, will be The Exchange proposes to delete the 3 Recently, the Exchange added a shell structure available for website viewing and current rules on arbitration (‘‘Current to its Rulebook with the purpose of improving Arbitration Rules’’), under Chapter 18, efficiency and readability and to align its rules printing in the Commission’s Public closer to those of its five sister exchanges, The and incorporate by reference The Nasdaq Stock Market LLC; Nasdaq BX, Inc.; Nasdaq 12 17 CFR 240.19b–4(f)(6). In addition, Rule 19b– Nasdaq Stock Market LLC’s (‘‘Nasdaq’’) PHLX LLC; Nasdaq GEMX, LLC; and Nasdaq MRX, 4(f)(6) requires a self-regulatory organization to give rules on arbitration at General 6 LLC (‘‘Affiliated Exchanges’’). The shell structure the Commission written notice of its intent to file (‘‘Proposed Arbitration Rules’’), into currently contains eight (8) Chapters which, once the proposed rule change at least five business days complete, will apply a common set of rules to the prior to the date of filing of the proposed rule Affiliated Exchanges. See Securities Exchange Act change, or such shorter time as designated by the 13 17 CFR 200.30–3(a)(12). Release No. 82173 (November 29, 2017), 82 FR Commission. The Exchange has satisfied this 1 15 U.S.C. 78s(b)(1). 57505 (December 5, 2017) (SR–ISE–2017–102). requirement. 2 17 CFR 240.19b–4. 4 http://www.finra.org/arbitration-and-mediation.

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these services. Under the Current objectives of Section 6(b)(5) of the Act,9 At any time within 60 days of the Arbitration Rules, Members and in particular, in that it is designed to filing of the proposed rule change, the associated persons of a Member are promote just and equitable principles of Commission summarily may subject to the FINRA Code of trade, to remove impediments to and temporarily suspend such rule change if Arbitration Procedure. perfect the mechanism of a free and it appears to the Commission that such Because the Affiliated Exchanges are open market and a national market action is necessary or appropriate in the also parties to similar Regulatory system, and, in general to protect public interest, for the protection of Contracts with FINRA that make their investors and the public interest, by investors, or otherwise in furtherance of members and associated persons of such promoting efficiency and structural the purposes of the Act. If the members subject to the FINRA Code of conformity of the Exchange’s processes Commission takes such action, the Arbitration Procedure, the Exchange with those of the Affiliated Exchanges Commission shall institute proceedings believes it is pertinent that a common and to make the Exchange’s Rulebook to determine whether the proposed rule set of rules on arbitration be included in easier to read and more accessible to its should be approved or disapproved. the General section of the Rulebook’s Members. The Exchange believes that IV. Solicitation of Comments shell. Nasdaq completed this process the adoption and harmonization of the recently 5 and, pursuant to subsequent arbitration rules and cross-reference Interested persons are invited to filings, the intention is to replace the updates are of a non-substantive nature. submit written data, views, and existing arbitration rules for each of the arguments concerning the foregoing, Affiliated Exchanges by incorporating B. Self-Regulatory Organization’s including whether the proposed rule the Nasdaq rules on arbitration by Statement on Burden on Competition change is consistent with the Act. reference. The Exchange does not believe that Comments may be submitted by any of Therefore, the Exchange will the proposed rule change will impose the following methods: incorporate by reference the Proposed any burden on competition not Electronic Comments Arbitration Rules in ‘‘General 6 necessary or appropriate in furtherance • Use the Commission’s internet Arbitration’’ of the shell’s ‘‘General of the purposes of the Act. The comment form (http://www.sec.gov/ Rules’’ section. proposed changes do not impose a rules/sro.shtml); or The relocation and harmonization of burden on competition because, as • Send an email to rule-comments@ the arbitration rules is part of the previously stated, they are (i) of a non- sec.gov. Please include File Number SR– Exchange’s continued effort to promote substantive nature, (ii) intended to ISE–2018–85 on the subject line. efficiency and conformity of its harmonize the structure of the processes with those of its Affiliated Exchange’s rules with those of its Paper Comments Exchanges.6 The Exchange believes that Affiliated Exchanges, and (iii) intended • Send paper comments in triplicate the adoption and placement of the to organize the Rulebook in a way that to Secretary, Securities and Exchange Proposed Arbitration Rules to their new it will ease the Members’ navigation and Commission, 100 F Street NE, location in the shell will facilitate the reading of the rules across the Affiliated Washington, DC 20549–1090. use of the Rulebook by Members of the Exchanges. Exchange who are members of other All submissions should refer to File Affiliated Exchanges. Moreover, the C. Self-Regulatory Organization’s Number SR–ISE–2018–85. This file proposed changes are of a conforming Statement on Comments on the number should be included on the nature and will not amend the Proposed Rule Change Received From subject line if email is used. To help the substance of the adopted rules other Members, Participants, or Others Commission process and review your comments more efficiently, please use than to update the language to that of No written comments were either only one method. The Commission will the Proposed Arbitration Rules, and to solicited or received. make conforming cross-reference post all comments on the Commission’s changes. III. Date of Effectiveness of the internet website (http://www.sec.gov/ ISE will continue to file proposed rule Proposed Rule Change and Timing for rules/sro.shtml). changes to amend its General 6 Rules Commission Action Copies of the submission, all subsequent amendments, all written until such time as it receives an Because the foregoing proposed rule statements with respect to the proposed exemption from the Securities and change does not: (i) Significantly affect rule change that are filed with the Exchange Commission, pursuant to its the protection of investors or the public Commission, and all written authority under Section 36 of the interest; (ii) impose any significant communications relating to the Exchange Act of 1934 (‘‘Act’’) and Rule burden on competition; and (iii) become proposed rule change between the 0–12 7 thereunder, from the Section operative for 30 days from the date on Commission and any person, other than 19(b) filing requirements to separately which it was filed, or such shorter time those that may be withheld from the file a proposed rule change to amend as the Commission may designate, it has public in accordance with the General 6. become effective pursuant to Section provisions of 5 U.S.C. 552, will be 19(b)(3)(A)(iii) of the Act 10 and 2. Statutory Basis available for website viewing and subparagraph (f)(6) of Rule 19b–4 printing in the Commission’s Public The Exchange believes that its thereunder.11 proposal is consistent with Section 6(b) Reference Room, 100 F Street NE, 8 Washington, DC 20549, on official of the Act, in general, and furthers the 9 15 U.S.C. 78f(b)(5). business days between the hours of 10 10 15 U.S.C. 78s(b)(3)(A)(iii). 5 See Securities Exchange Act Release No. 83834 11 17 CFR 240.19b–4(f)(6). In addition, Rule 19b– a.m. and 3 p.m. Copies of the filing also (August 13, 2018), 83 FR 41115 (August 17, 2018) 4(f)(6) requires a self-regulatory organization to give will be available for inspection and (SR–NASDAQ–2018–067). the Commission written notice of its intent to file copying at the principal office of the 6 See footnote 3. the proposed rule change at least five business days Exchange. All comments received will 7 See 17 CFR 240.0–12; Securities Exchange Act prior to the date of filing of the proposed rule Release No. 39624 (February 5, 1998), 63 FR 8101 change, or such shorter time as designated by the be posted without change. Persons (February 18, 1998). Commission. The Exchange has satisfied this submitting comments are cautioned that 8 15 U.S.C. 78f(b). requirement. we do not redact or edit personal

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identifying information from comment The text of the proposed rule change believes it is pertinent that a common submissions. You should submit only is available on the Exchange’s website at set of rules on arbitration be included in information that you wish to make http://nasdaqmrx.cchwallstreet.com/, at the General section of the Rulebook’s available publicly. All submissions the principal office of the Exchange, and shell. Nasdaq completed this process should refer to File Number SR–ISE– at the Commission’s Public Reference recently 5 and, pursuant to subsequent 2018–85 and should be submitted on or Room. filings, the intention is to replace the before November 20, 2018. existing arbitration rules for each of the II. Self-Regulatory Organization’s For the Commission, by the Division of Affiliated Exchanges by incorporating Statement of the Purpose of, and the Nasdaq rules on arbitration by Trading and Markets, pursuant to delegated Statutory Basis for, the Proposed Rule 12 reference. authority. Change Eduardo A. Aleman, Therefore, the Exchange will Assistant Secretary. In its filing with the Commission, the incorporate by reference the Proposed Arbitration Rules in ‘‘General 6 [FR Doc. 2018–23622 Filed 10–29–18; 8:45 am] Exchange included statements concerning the purpose of and basis for Arbitration’’ of the shell’s ‘‘General BILLING CODE 8011–01–P the proposed rule change and discussed Rules’’ section. any comments it received on the The relocation and harmonization of SECURITIES AND EXCHANGE proposed rule change. The text of these the arbitration rules is part of the COMMISSION statements may be examined at the Exchange’s continued effort to promote places specified in Item IV below. The efficiency and conformity of its [Release No. 34–84479; File No. SR–MRX– Exchange has prepared summaries, set processes with those of its Affiliated 2018–32] forth in sections A, B, and C below, of Exchanges.6 The Exchange believes that the adoption and placement of the Self-Regulatory Organizations; Nasdaq the most significant aspects of such statements. Proposed Arbitration Rules to their new MRX, LLC; Notice of Filing and location in the shell will facilitate the Immediate Effectiveness of Proposed A. Self-Regulatory Organization’s use of the Rulebook by Members of the Rule Change To Delete Current Rules Statement of the Purpose of, and Exchange who are members of other on Arbitration, Under Chapter 18 Statutory Basis for, the Proposed Rule Affiliated Exchanges. Moreover, the Change October 24, 2018. proposed changes are of a conforming Pursuant to Section 19(b)(1) of the 1. Purpose nature and will not amend the substance of the adopted rules other Securities Exchange Act of 1934 The Exchange proposes to delete the 1 2 than to update the language to that of (‘‘Act’’), and Rule 19b–4 thereunder, rules on arbitration, currently under notice is hereby given that on October the Proposed Arbitration Rules, and to Chapter 18, and incorporate by make conforming cross-reference 9, 2018, Nasdaq MRX, LLC (‘‘MRX’’ or reference the Nasdaq rules on ‘‘Exchange’’) filed with the Securities changes. arbitration at General 6 of Nasdaq’s MRX will continue to file proposed and Exchange Commission (‘‘SEC’’ or rulebook into General 6 of the ‘‘Commission’’) the proposed rule rule changes to amend its General 6 Exchange’s Rulebook. Rules until such time as it receives an change as described in Items I, II, and The Exchange adopted the Current III, below, which Items have been exemption from the Securities and Arbitration Rules to ensure a fair and Exchange Commission, pursuant to its prepared by the Exchange. The efficient manner in which to handle any Commission is publishing this notice to authority under Section 36 of the dispute, claim or controversy arising out Exchange Act of 1934 (‘‘Act’’) and Rule solicit comments on the proposed rule of, or in connection with, the business change from interested persons. 0–12 7 thereunder, from the Section of any Member of the Exchange. To help 19(b) filing requirements to separately I. Self-Regulatory Organization’s administer the process of dispute file a proposed rule change to amend Statement of the Terms of Substance of resolution, the Exchange and FINRA are General 6. the Proposed Rule Change parties to a Regulatory Contract, pursuant to which FINRA has agreed to 2. Statutory Basis The Exchange proposes to delete the perform certain functions and provide current rules on arbitration (‘‘Current The Exchange believes that its access to certain services, including: Arbitration Rules’’), under Chapter 18, proposal is consistent with Section 6(b) member regulation and registration; 8 and incorporate by reference The of the Act, in general, and furthers the non-real time market surveillance; 9 Nasdaq Stock Market LLC’s (‘‘Nasdaq’’) objectives of Section 6(b)(5) of the Act, examinations and investigations; and rules on arbitration at General 6 in particular, in that it is designed to dispute resolution. FINRA currently (‘‘Proposed Arbitration Rules’’), into promote just and equitable principles of operates the largest securities dispute General 6 of the Exchange’s rulebook’s trade, to remove impediments to and resolution forum in the United States,4 (‘‘Rulebook’’) shell structure.3 perfect the mechanism of a free and and has given the Exchange access to open market and a national market 12 17 CFR 200.30–3(a)(12). these services. Under the Current system, and, in general to protect 1 15 U.S.C. 78s(b)(1). Arbitration Rules, Members and investors and the public interest, by 2 17 CFR 240.19b–4. associated persons of a Member are promoting efficiency and structural 3 Recently, the Exchange added a shell structure subject to the FINRA Code of conformity of the Exchange’s processes to its Rulebook with the purpose of improving Arbitration Procedure. efficiency and readability and to align its rules Because the Affiliated Exchanges are 5 See Securities Exchange Act Release No. 83834 closer to those of its five sister exchanges, The (August 13, 2018), 83 FR 41115 (August 17, 2018) Nasdaq Stock Market LLC; Nasdaq BX, Inc.; Nasdaq also parties to similar Regulatory (SR–NASDAQ–2018–067). PHLX LLC; Nasdaq ISE, LLC; and Nasdaq GEMX, Contracts with FINRA that make their 6 LLC (‘‘Affiliated Exchanges’’). The shell structure members and associated persons of such See footnote 3. 7 See 17 CFR 240.0–12; Securities Exchange Act currently contains eight (8) Chapters which, once members subject to the FINRA Code of complete, will apply a common set of rules to the Release No. 39624 (February 5, 1998), 63 FR 8101 Affiliated Exchanges. See Securities Exchange Act Arbitration Procedure, the Exchange (February 18, 1998). Release No. 82172 (November 29, 2017), 82 FR 8 15 U.S.C. 78f(b). 57495 (December 5, 2017) (SR–MRX–2017–26). 4 http://www.finra.org/arbitration-and-mediation. 9 15 U.S.C. 78f(b)(5).

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with those of the Affiliated Exchanges to determine whether the proposed rule For the Commission, by the Division of and to make the Exchange’s Rulebook should be approved or disapproved. Trading and Markets, pursuant to delegated easier to read and more accessible to its authority.12 Members. The Exchange believes that IV. Solicitation of Comments Eduardo A. Aleman, the adoption and harmonization of the Interested persons are invited to Assistant Secretary. arbitration rules and cross-reference submit written data, views, and [FR Doc. 2018–23623 Filed 10–29–18; 8:45 am] updates are of a non-substantive nature. arguments concerning the foregoing, BILLING CODE 8011–01–P B. Self-Regulatory Organization’s including whether the proposed rule change is consistent with the Act. Statement on Burden on Competition SECURITIES AND EXCHANGE Comments may be submitted by any of The Exchange does not believe that COMMISSION the following methods: the proposed rule change will impose [Release No. 34–84480; File No. SR– any burden on competition not Electronic Comments CboeBZX–2018–066] necessary or appropriate in furtherance • of the purposes of the Act. The Use the Commission’s internet Self-Regulatory Organizations; Cboe proposed changes do not impose a comment form (http://www.sec.gov/ BZX Exchange, Inc.; Notice of Filing of burden on competition because, as rules/sro.shtml); or a Proposed Rule Change To Permit the previously stated, they are (i) of a non- • Send an email to rule-comments@ Listing and Trading of P.M.-Settled substantive nature, (ii) intended to sec.gov. Please include File Number SR– Series on Certain Broad-Based Index harmonize the structure of the MRX–2018–32 on the subject line. Options on a Pilot Basis Exchange’s rules with those of its Affiliated Exchanges, and (iii) intended Paper Comments October 24, 2018. to organize the Rulebook in a way that Pursuant to Section 19(b)(1) of the • Send paper comments in triplicate it will ease the Members’ navigation and Securities Exchange Act of 1934 (the reading of the rules across the Affiliated to Secretary, Securities and Exchange ‘‘Act’’),1 and Rule 19b–4 thereunder,2 Exchanges. Commission, 100 F Street NE, notice is hereby given that on October Washington, DC 20549–1090. 11, 2018, Cboe BZX Exchange, Inc. filed C. Self-Regulatory Organization’s with the Securities and Exchange Statement on Comments on the All submissions should refer to File Number SR–MRX–2018–32. This file Commission (the ‘‘Commission’’ or Proposed Rule Change Received From ‘‘SEC’’) the proposed rule change as Members, Participants, or Others number should be included on the subject line if email is used. To help the described in Items I, II, and III below, No written comments were either Commission process and review your which Items have been prepared by the solicited or received. comments more efficiently, please use Exchange. The Commission is publishing this notice to solicit III. Date of Effectiveness of the only one method. The Commission will post all comments on the Commission’s comments on the proposed rule change Proposed Rule Change and Timing for from interested persons. Commission Action internet website (http://www.sec.gov/ rules/sro.shtml). I. Self-Regulatory Organization’s Because the foregoing proposed rule Statement of the Terms of Substance of change does not: (i) Significantly affect Copies of the submission, all the Proposed Rule Change the protection of investors or the public subsequent amendments, all written interest; (ii) impose any significant statements with respect to the proposed Cboe BZX Exchange, Inc. (the burden on competition; and (iii) become rule change that are filed with the ‘‘Exchange’’ or ‘‘BZX Options’’) operative for 30 days from the date on Commission, and all written proposes to permit the listing and which it was filed, or such shorter time communications relating to the trading of P.M.-settled series on certain as the Commission may designate, it has proposed rule change between the broad-based index options on a pilot become effective pursuant to Section Commission and any person, other than basis. 19(b)(3)(A)(iii) of the Act 10 and those that may be withheld from the The text of the proposed rule change subparagraph (f)(6) of Rule 19b–4 public in accordance with the is also available on the Exchange’s thereunder.11 provisions of 5 U.S.C. 552, will be website (http://www.cboe.com/ At any time within 60 days of the available for website viewing and AboutCBOE/CBOELegal filing of the proposed rule change, the printing in the Commission’s Public RegulatoryHome.aspx), at the Commission summarily may Reference Room, 100 F Street NE, Exchange’s Office of the Secretary, and temporarily suspend such rule change if Washington, DC 20549, on official at the Commission’s Public Reference it appears to the Commission that such business days between the hours of 10 Room. action is necessary or appropriate in the a.m. and 3 p.m. Copies of the filing also II. Self-Regulatory Organization’s public interest, for the protection of will be available for inspection and Statement of the Purpose of, and investors, or otherwise in furtherance of copying at the principal office of the Statutory Basis for, the Proposed Rule the purposes of the Act. If the Exchange. All comments received will Change Commission takes such action, the be posted without change. Persons In its filing with the Commission, the Commission shall institute proceedings submitting comments are cautioned that Exchange included statements we do not redact or edit personal 10 concerning the purpose of and basis for 15 U.S.C. 78s(b)(3)(A)(iii). identifying information from comment 11 the proposed rule change and discussed 17 CFR 240.19b–4(f)(6). In addition, Rule 19b– submissions. You should submit only 4(f)(6) requires a self-regulatory organization to give any comments it received on the information that you wish to make the Commission written notice of its intent to file proposed rule change. The text of these the proposed rule change at least five business days available publicly. All submissions prior to the date of filing of the proposed rule should refer to File Number SR–MRX– 12 17 CFR 200.30–3(a)(12). change, or such shorter time as designated by the 2018–32 and should be submitted on or Commission. The Exchange has satisfied this 1 15 U.S.C. 78s(b)(1). requirement. before November 20, 2018. 2 17 CFR 240.19b–4.

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statements may be examined at the trading additional series in response to other options exchanges close trading in places specified in Item IV below. The customer demand. certain options on the last trading day Exchange has prepared summaries, set The proposed rule change amends for certain classes.4 forth in sections A, B, and C below, of Rule 29.10(a) to state that, on their last If the Exchange were to propose an the most significant aspects of such trading day, transactions in P.M.-settled extension of the XSPPM Pilot Program statements. XSP options may be effected on the or should the Exchange propose to make Exchange between the hours of 9:30 the XSPPM Pilot Program permanent, A. Self-Regulatory Organization’s a.m. and 4:00 p.m. Eastern time (as the Exchange would submit a filing Statement of the Purpose of, and the opposed to the normal trading hours for proposing such amendments to the Statutory Basis for, the Proposed Rule non-expiring P.M.-settled XSP options, XSPPM Pilot Program. Further, any Change which are from 9:30 a.m. to 4:15 p.m. positions established under the XSPPM 1. Purpose Eastern time). XSP options are typically Pilot Program would not be impacted by priced in the market based on the expiration of the XSPPM Pilot The proposed rule change permits the corresponding futures values. The Program. For example, if the Exchange listing and trading of P.M.-settled series primary listing markets for the lists a P.M.-settled XSP option that on certain broad-based index options on component securities that comprise the expires after the XSPPM Pilot Program 3 a pilot basis. First, the proposed rule S&P 500 Index close trading in those expires (and is not extended), then those change would permit the listing and securities at 4:00 p.m. The primary positions would continue to exist. If the trading of XSP options with third- listing exchanges for the component pilot were not extended, then the Friday-of-the-month expiration dates, securities disseminate closing prices of positions could continue to exist. whose exercise settlement value will be the component securities, which are However, any further trading in those based on the closing index value on the used to calculate the exercise settlement series would be restricted to expiration day (‘‘P.M.-settled’’) for an value of the S&P 500 Index. The transactions where at least one side of initial period of twelve months (the Exchange believes that, under normal the trade is a closing transaction. ‘‘XSPPM Pilot Program’’) from the date trading circumstances, the primary As part of the XSPPM Pilot Program, of approval of this proposed rule listing markets have sufficient the Exchange will submit a pilot report change. Second, the proposed rule bandwidth to prevent any data queuing to the Commission at least two months change would permit the listing and that would cause any trades that are prior to the expiration date of the pilot. trading of P.M.-settled options on broad- executed prior to the closing time from This annual report will contain an based indexes with weekly expirations being reported after 4:00 p.m. Despite analysis of volume, open interest, and (‘‘Weeklys’’) and end-of-month the fact that the exercise settlement trading patterns. The analysis would expirations (‘‘EOMs’’) for an initial value will be fixed at or soon after 4:00 examine trading in the proposed option period of 12 months (the ‘‘Nonstandard p.m., if the Exchange did not close product as well as trading in the Expirations Pilot Program’’) from the trading in expiring P.M.-settled XSP securities that comprise the S&P 500 date of approval of this proposed rule options at 4:00 p.m. on their last trading Index. In addition, for series that exceed change. day, trading in expiring P.M.-settled certain minimum open interest XSP options would continue for an XSPPM Pilot Program parameters, the annual report will additional fifteen minutes until 4:15 provide analysis of index price volatility Proposed Rule 29.11(a)(6) permits the p.m. and would not be able to be priced and, if needed, share trading activity. listing and trading, in addition to A.M.- on corresponding futures values, but The annual report will contain the settled XSP options, of P.M.-settled XSP rather the known cash value. At the following volume and open interest options with third-Friday-of-the-month same time, the prices of non-expiring data: expiration dates on a pilot basis for an P.M.-settled XSP option series would (1) Monthly volume aggregated for all initial period of 12 months from the continue to move and be priced in trades; date of approval of this proposed rule response to changes in corresponding (2) monthly volume aggregated by change. XSP options are A.M.-settled futures prices. expiration date; pursuant to the generic listing criteria in A potential pricing divergence could (3) monthly volume for each Rule 29.11(a)(5). The Exchange believes occur between 4:00 p.m. and 4:15 p.m. individual series; permitting the trading of XSP options on on the final trading day in expiring (4) month-end open interest a P.M.-settled basis will encourage P.M.-settled XSP options (e.g. switch aggregated for all series; greater trading in XSP options. from pricing off of futures to cash). (5) month-end open interest Other than settlement and closing Further, the switch from pricing off of aggregated by expiration date; and time on the last trading day (as futures to cash can be a difficult and (6) month-end open interest for each discussed below), contract terms for risky switchover for liquidity providers. individual series. The annual report will also contain P.M.-settled XSP options will be the As a result, without closing expiring the information noted above for same as the A.M.-settled XSP options. contracts at 4:00 p.m., it is foreseeable expiration Friday A.M.-settled XSP The proposed contract would use a $100 that Market-Makers could react by option series, if applicable, for the multiplier. The minimum trading widening spreads in order to period covered in the annual report. In increments, strike price intervals, and compensate for the additional risk. addition to the annual report, the expirations would be the same as the Therefore, the Exchange believes that, in Exchange will provide the Commission A.M.-settled XSP option series. P.M.- order to mitigate potential investor confusion and the potential for with interim reports of the information settled XSP options would have increased costs to investors, it is listed in (1) through (6) above. European-style exercise. The Exchange appropriate to cease trading in the will also have flexibility to open for expiring P.M.-settled XSP contracts at 4 See Cboe Options Rule 24.6, Interpretations and 4:00 p.m. The Exchange does not Policies .01 (options with Quarterly Index 3 The Exchange is authorized to list for trading Expirations), .03 (Cboe S&P 500 A.M./P.M. Basis options that overlie the Mini-SPX Index (‘‘XSP’’) believe the proposed change will impact options), .04 (P.M.-settled SPX options with third and the Russell 2000 Index (‘‘RUT’’). See Rule volatility on the underlying cash market Friday-of-the-month expiration and P.M.-settled 29.11(a). at the close on third Fridays. Further, XSP options), and .05 (MSCI EAFE Index options).

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In the annual report, the annual report dates for an initial period of 12 months Friday expiring Weekly will expire on would contain the following analysis of from the date of approval of this the previous business day. trading patterns in expiration Friday, proposed rule change. The Nonstandard Proposed Rule 29.11(a)(2) [sic] P.M.-settled XSP option series in the Expirations Pilot Program will permit permits the Exchange to open for XSPPM Pilot Program: both Weeklys and EOMs as discussed trading EOMs on any broad-based index (1) A time series analysis of open below. Contract terms for the Weekly eligible for standard options trading to interest; and and EOM expirations will be similar to expire on the last trading day of the (2) an analysis of the distribution of those of the A.M.-settled broad-based month. EOMs will be subject to all trade sizes. index options, except that the Weekly provisions of Rule 29.11 and treated the Also, for series that exceed certain and EOM expirations will be P.M.- same as options on the same underlying minimum parameters, the annual report settled. index that expire on the third Friday of will also contain the following analysis Proposed Rule 29.11(j)(1) permits the the expiration month. However, EOMs related to index price changes and, if Exchange to open for trading Weeklys will be P.M.-settled, and new series of needed, underlying share trading on any broad-based index eligible for EOMs may be added up to and volume at the close on expiration standard options trading to expire on including on the expiration date for an Fridays: any Monday, Wednesday, or Friday expiring EOM. (1) A comparison of index price (other than the third Friday-of-the- The maximum number of expirations changes at the close of trading on a month or days that coincide with an that may be listed for EOMs in a given given expiration Friday with EOM). Weeklys will be subject to all class is the same as the maximum comparable price changes from a control provisions of Rule 29.11 and will be number of expirations permitted in Rule sample. The data will include a treated the same as options on the same 29.11(a)(3) for standard options on the calculation of percentage price changes underlying index that expire on the same broad-based index.7 EOMs need for various time intervals and compare third Friday of the expiration month. not be for consecutive end-of-month However, Weeklys will be P.M.-settled, that information to the respective expirations. However, the expiration and new Weekly series may be added control sample. Raw percentage price date of a non-consecutive expiration up to and including on the expiration change data as well as percentage price may not be beyond what would be date for an expiring Weekly. change data normalized for prevailing considered the last expiration date if the market volatility, as measured by an The maximum number of expirations that may be listed for each Weekly (i.e., maximum number of expirations were appropriate index as agreed by the listed consecutively. EOMs that are first Commission and the Exchange, would a Monday expiration, a Wednesday expiration, or Friday expiration, as listed in a given class may expire up to be provided; and four weeks from the actual listing date. (2) a calculation of share volume for applicable) in a given class will be the same as the maximum number of Other expirations in the same class are a sample set of the component securities not counted as part of the maximum representing an upper limit on share expirations permitted in Rule 29.11(a)(3) for standard options on the number of EOMs for a broad-based trading that could be attributable to index class. expiring in-the-money series. The data, same broad-based index.6 Weeklys The proposed rule change amends if needed, will include a comparison of would not need to be for consecutive Rule 29.11(c)(5)(C) to provide that the the calculated share volume for Monday, Wednesday, or Friday lowest strike interval for series of XSP securities in the sample set to the expirations, as applicable. However, the options listed under the Nonstandard average daily trading volumes of those expiration date of a non-consecutive Expirations Pilot Program will be $0.50. securities over a sample period. expiration would not be permitted With respect to XSP, this is consistent The minimum open interest beyond what would be considered the with the minimum strike interval for parameters, control sample, time last expiration date if the maximum XSP options listed under the Short intervals, method for randomly selecting number of expirations were listed Term Series Program.8 Additionally, the component securities, and sample consecutively. Weeklys that are first this is consistent with the minimum periods would be determined by the listed in a given class could expire up strike interval for options on the Exchange and the Commission. to four weeks from the actual listing Additionally, the Exchange will date. If the last trading day of a month Standard & Poor’s Depository Receipts provide the Commission with any is a Monday, Wednesday, or Friday and Trust (SPY), which is an ETF that like additional data or analyses the the Exchange lists EOMs and Weeklys, XSP tracks the performance of 1/10th as applicable, in a given class, the the value of the S&P 500 Index, with Commission requests because it deems 9 such data or analyses necessary to Exchange will list an EOM instead of a weekly expirations. determine whether the XSPPM Pilot Weekly in the given class. Other Weeklys and EOMs will be subject to Program is consistent with the Exchange expirations in the same class are not the same rules that currently govern the Act. The Exchange will make public all counted as part of the maximum trading of standard monthly broad- data and analyses it submits to the number of Weeklys for a broad-based based index options, including sales Commission under the XSPPM Pilot index class. If the Exchange is not open practice rules, margin requirements, and Program. for business on a respective Monday, floor trading procedures. Contract terms Other exchanges currently have pilots the normally Monday expiring Weeklys for Weeklys and EOMs will be the same that permit P.M.-settled index options.5 would expire on the following business as those for standard monthly broad- day. If the Exchange is not open for based index options. Since Weeklys and Nonstandard Expirations Pilot Program business on a respective Wednesday or EOMs will be new types of series, and The proposed rule change permits the Friday, the normally Wednesday or not a new class, the Exchange proposes listing and trading, on a pilot basis, of that Weeklys and EOMs will be P.M.-settled options on broad-based 6 Pursuant to Rule 29.11(a)(3), the Exchange may aggregated for any applicable reporting list up to six expiration months at any one time. indexes with nonstandard expiration Therefore, pursuant to the proposed rule change, the Exchange may list a maximum of six Weekly 7 Id. 5 See Cboe Options Rule 24.9, Interpretation and expirations under the Nonstandard Expirations 8 See Rule 29.11(c)(5)(C). Policy .14 and Phlx Rule 1101A, Commentary .05. Pilot Program. 9 See Rule 19.6, Interpretation and Policy .05(f).

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and other requirements.10 Pursuant to (2) Volume in Weekly and EOM series The data will include a calculation of new proposed Rule 29.11(j)(4), aggregated by expiration date; percentage price changes for various transactions in expiring Weeklys and (3) Month-end open interest time intervals and compare that EOMs may be effected on the Exchange aggregated for all Weekly and EOM information to the respective control between the hours of 9:30 a.m. and 4:00 series; sample. Raw percentage price change p.m. (Eastern time). (4) Month-end open interest for EOM data as well as percentage price change As stated above, this proposed rule series aggregated by expiration date and data normalized for prevailing market change establishes a Nonstandard open interest for Weekly series volatility, as measured by an Expirations Pilot Program for broad- aggregated by expiration date; appropriate index agreed to by the based index options on a pilot basis, for (5) Ratio of monthly aggregate volume Commission and the Exchange, will be an initial period of 12 months from the in Weekly and EOM series to total provided; and date of approval of this proposed rule monthly class volume; and (2) If needed, a calculation of share change. If the Exchange were to propose (6) Ratio of month-end open interest volume for a sample set of the an extension of the Nonstandard in EOM series to total month-end class component securities representing an Expirations Pilot Program or should the open interest and ratio of open interest upper limit on share trading that could Exchange propose to make it permanent, in each Weekly series to total class open be attributable to expiring in-the-money the Exchange would submit a filing interest. Weekly and EOM series. The data, if proposing such amendments. Further, In addition, the annual report will needed, will include a comparison of any positions established under the contain the information noted above for the calculated share volume for Nonstandard Expirations Pilot Program standard expiration Friday, A.M.-settled securities in the sample set to the would not be impacted by the series, if applicable, for the period average daily trading volumes of those expiration of the pilot. For example, if covered in the annual report as well as securities over a sample period. the Exchange lists a Weekly or EOM that for the six-month period prior to the The minimum open interest expires after the Nonstandard initiation of the pilot. parameters, control sample, time Expirations Pilot Program expires (and Upon request by the SEC, the intervals, method for selecting the is not extended), then those positions Exchange will provide a data file component securities, and sample would continue to exist. However, any containing: periods will be determined by the further trading in those series would be (1) Weekly and EOM option volume Exchange and the Commission. restricted to transactions where at least data aggregated by series, and Additionally, the Exchange will one side of the trade is a closing (2) Weekly open interest for each provide the Commission with any transaction. expiring series and EOM month-end additional data or analyses the As part of the Nonstandard open interest for expiring series. Commission requests because it deems Expirations Pilot Program, the Exchange In the annual report, the Exchange such data or analyses necessary to will submit a pilot report to the also proposes to identify Weekly and determine whether the Nonstandard Commission at least two months prior to EOM trading patterns by undertaking a Expirations Pilot Program is consistent the expiration date of the pilot (the time series analysis of open interest in with the Exchange Act. The Exchange ‘‘annual report’’). The annual report will Weekly and EOM series aggregated by will make public all data and analyses contain an analysis of volume, open expiration date compared to open it submits to the Commission under the interest, and trading patterns. In interest in near-term standard expiration Nonstandard Expirations Pilot Program. addition, for series that exceed certain Friday A.M.-settled series in order to Other exchanges currently have pilots minimum open interest parameters, the determine whether users are shifting that have weekly and end-of-month annual report will provide analysis of positions from standard series to expirations.11 the index price volatility, and, if Weekly and EOM series. In addition, to needed, share trading activity. the extent that data on other weekly or Additional Information For all Weekly and EOM series, the monthly P.M.-settled products from Precedent exists for P.M.-settled annual report will contain the following other exchanges is publicly available, broad-based index options, as other volume and open interest data for each the report will also compare open options exchanges list P.M.-settled broad-based index overlying Weekly interest with these options in order to broad-based index options.12 The and EOM options: determine whether users are shifting Exchange does not believe that any (1) Monthly volume aggregated for all positions from other weekly or monthly market disruptions will be encountered Weekly and EOM series; P.M.-settled products to the Weekly and with the introduction of listing P.M.- EOM series. Declining open interest in settled options on the Exchange. The 10 Rule 29.5(a) requires Options Members to standard series or the weekly or Exchange will monitor for any such comply with the applicable rules of Cboe Options monthly P.M.-settled products of other with respect to position limits for broad-based disruptions or the development of any index options for options traded on Cboe Options. exchanges accompanied by rising open factors that would cause such Cboe Options Rule 24.4, Interpretation and Policy interest in Weekly and EOM series disruptions. .03 sets forth the reporting requirements for certain would suggest that users are shifting The Exchange notes that P.M.-settled market indexes that do not have position limits, positions. options predominate in the over-the- including XSP and RUT, and would apply to XSP and RUT options traded on the Exchange pursuant For each Weekly and EOM expiration counter (‘‘OTC’’) market, and the to Rule 29.5(a); see also Cboe Options Rule 24.4(b), that has open interest that exceeds Exchange is not aware of any adverse which provides that Weeklys and EOMs will be certain minimum thresholds, the annual effects in the stock market attributable aggregated with option contracts on the same broad- report will contain the following to the P.M.-settlement feature. The based index and will be subject to the overall position limit, and would apply to Weeklys/EOMs analysis related to index price changes traded on the Exchange pursuant to Rule 29.5(a). and, if needed, underlying share trading 11 See Cboe Options Rule 24.9(e); and Phlx Rule The Exchange notes that the proposed aggregation volume at the close on expiration dates: 1101A(b)(vii). is consistent with the aggregation requirements or (1) A comparison of index price 12 See, e.g., Cboe Options Rule 24.9(a)(4) (OEX not other types of option series (e.g., quarterly expiring changes at the close of trading on a listed as A.M.-settled) and Interpretation and Policy options) that may be listed on the Exchange and .14 (permits listing of P.M.-settled SPX and XSP that do not expire on the customary ‘‘third Friday’’ given expiration date with comparable options); and PHLX Rule 1101A, Commentary .05 (see Cboe Options Rule 24.4(e)). price changes from a control sample. (permits listing of P.M.-settled NDX options).

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Exchange is merely proposing to offer a Exchange believes its Members will not products as listed and traded on Cboe P.M.-settled product in an exchange have a capacity issue as a result of this Options will apply to these products environment that offers the benefit of proposed rule change. The Exchange when listed and traded on the added transparency, price discovery, also represents that it does not believe Exchange. The proposed rule change and stability. In response to any this expansion will cause fragmentation will also result in similar regulatory potential concerns that disruptive of liquidity. The Exchange will monitor treatment for similar option products. trading conduct could occur as a result the trading volume associated with the 2. Statutory Basis of the concurrent listing and trading of additional options series listed as a two index option products based on the result of this proposed rule change and The Exchange believes the proposed same index but for which different the effect (if any) of these additional rule change is consistent with the settlement methodologies exist (i.e., one series on market fragmentation and on Securities Exchange Act of 1934 (the is A.M.-settled and one is P.M.-settled), the capacity of the Exchange’s ‘‘Act’’) and the rules and regulations the Exchange notes that Cboe Options automated systems. thereunder applicable to the Exchange lists and trades both A.M.-settled and P.M.-settled options would be subject and, in particular, the requirements of P.M.-settled SPX options, and Phlx lists to all provisions of Rule 29.11. P.M.- Section 6(b) of the Act.16 Specifically, and trades both A.M.-settled and P.M.- settled options would be subject to the the Exchange believes the proposed rule settled NDX options. The Exchange is same rules that govern the trading of change is consistent with the Section not aware of any market disruptions A.M.-settled options overlying the same 6(b)(5) 17 requirements that the rules of occurring as a result of these exchanges indexes, including sales practice rules, an exchange be designed to prevent offering both products. margin requirements, and floor trading fraudulent and manipulative acts and The adoption of P.M.-settled options procedures. P.M.-settled options will be practices, to promote just and equitable on an exchange that lists A.M.-settled subject to the margin requirements set principles of trade, to foster cooperation options in the same class would provide forth in Chapter 28 and the position and coordination with persons engaged greater spread opportunities. This limits set forth in Rule 29.5. Chapter 28 in regulating, clearing, settling, manner of trading in different products imposes the margin requirements of processing information with respect to, allows a market participant to take either Cboe Options or the New York and facilitating transactions in advantage of the different expiration Stock Exchange on Exchange Options securities, to remove impediments to times, providing expanded trading Members. Similarly, Rule 29.5 imposes and perfect the mechanism of a free and opportunities. In the options market position (and exercise) limits for broad- open market and a national market currently, market participants regularly based index options of Cboe Options on system, and, in general, to protect trade similar or related products in Exchange Options Members. Since P.M.- investors and the public interest. conjunction with each other, which settled options will be a new type of The Exchange believes the proposed contributes to overall market liquidity. series, and not a new class, the rule change will attract order flow to the The Exchange represents it has an Exchange proposes that the P.M.-settled Exchange, increase the variety of listed adequate surveillance program in place options will be aggregated for any options to investors, and provide a for index options. The Exchange is a applicable reporting and other valuable hedge tool to investors. The member of the Intermarket Surveillance requirements.13 Currently, there are no Exchange believes the proposed rule Group (‘‘ISG’’), which is comprised of position limits on RUT and XSP change will also remove impediments to an international group of exchanges, options.14 Therefore, there will be no and perfect the mechanism of a free and market centers, and market regulators. position limits on P.M.-settled RUT and open market, and in general protect The purpose of ISG is to provide a XSP options. P.M.-settled XSP options investors by expanding the ability of framework for the sharing of and Weekly/EOM broad-based index investors to hedge risks against market information and the coordination of options are currently authorized for movements stemming from economic regulatory efforts among exchanges listing on Cboe Options,15 and thus the releases or market events that occur trading securities and related products same margin requirements and position during the month and at the end of the to address potential intermarket and exercise limits that apply to these month. Accordingly, the Exchange manipulations and trading abuses. ISG believes that P.M.-settled options will plays a crucial role in information 13 See Rule 29.5(a), which requires Options create greater trading and hedging sharing among markets that trade Members to comply with the applicable rules of opportunities and flexibility, and securities, options on securities, Cboe Options with respect to position limits for broad-based index options for options traded on provide customers with the ability to security futures products, and futures Cboe Options. Cboe Options Rule 24.4(b), which more closely tailor their investment and options on broad-based security applies to index options traded on the Exchange objectives. indexes. A list of identifying current ISG pursuant to Rule 29.5(a), provides that Nonstandard The Commission has previously members is available at https:// Expirations will be aggregated with option contracts on the same broad-based index and subject to the stated that when cash-settled index www.isgportal.org/isgPortal/public/ overall position limit. Additionally, Cboe Options options were first introduced in the members.htm. Rule 24.4(d), which applies to index options traded 1980s, they generally utilized closing- The Exchange has analyzed its on the Exchange pursuant to Rule 29.5(a), positions price settlement procedures (i.e., P.M. capacity and represents that it believes in reduced-value index options will be aggregated with positions in full-value indices. The Exchange settlement). The Commission stated it the Exchange and OPRA have the notes that the proposed aggregation is consistent became concerned about the impact of necessary systems capacity to handle with the aggregation requirements for other types of P.M. settlement on cash-settled index the additional traffic associated with the option series (e.g. quarterly expiring options) that options on the markets for the listing of P.M.-settled XSP and Weekly/ are listed on the Exchange and that do not expire on the customary ‘‘third Friday.’’ See Cboe Options underlying stocks at the close on EOM option series up to the proposed Rule 24.4 (which applies to the Exchange pursuant expiration Fridays, especially during the number of possible expirations and to Rule 29.5(a)). quarterly expirations of the third Friday strike prices. The Exchange believes any 14 See Cboe Options Rule 24.4(a) (which applies of March, June, September, and additional traffic that would be to the Exchange pursuant to Rule 29.5(a)). December when options, index futures, 15 Similarly, pursuant to Cboe Options Chapter generated from the introduction of P.M.- 12, Cboe Options Trading Permit Holders may settled XSP and Weekly/EOM options request to have New York Stock Exchange margin 16 15 U.S.C. 78f(b). series will be manageable. The requirements apply to their trading. 17 15 U.S.C. 78f(b)(5).

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and options on index futures all expire from 9:30 a.m. to 4:15 p.m. Eastern time) proposed rule change has made the simultaneously. The Commission will prevent potential pricing Exchange more attractive or favorable. expressed concerns that P.M. settlement divergence that could occur between Further, this product could offer a was believed to have contributed to 4:00 p.m. and 4:15 p.m. on the final competitive alternative to other existing above-average volume and added trading day in expiring P.M.-settled XSP investment products that seek to allow market volatility on those days, which options. Without closing expiring Members to gain broad market exposure. sometimes led to sharp price contracts at 4:00 p.m., it is foreseeable Finally, all options exchanges are free to movements during the last hour of that Market-Makers would react by compete by listing and trading index trading, as a consequence of which the widening spreads in order to options that are P.M.-settled. Other close of trading on the quarterly compensate for the additional risk. exchanges currently have pilots that expiration Friday became known as the Therefore, the Exchange believes that, in permit P.M.-settled index options 23 or ‘‘triple witching hour.’’ The order to mitigate potential investor Weeklys/EOMs.24 Commission observed that besides confusion and the potential for The proposed rule change to permit contributing to investor anxiety, increased costs to investors, it is transactions on the Exchange in P.M.- heightened volatility during the appropriate to cease trading in the settled XSP and Weekly/EOM options expiration periods created the expiring P.M.-settled XSP and Weekly/ on their last trading day between the opportunity for manipulation and other EOM contracts at 4:00 p.m. The hours of 9:30 a.m. and 4:00 p.m. Eastern abusive trading practices in anticipation Exchange does not believe the proposed time (as opposed to the normal trading of the liquidity constraints.18 change will impact volatility on the hours for non-expiring P.M.-settled XSP However, the Exchange believes that underlying cash market at the close on and Weekly/EOM options, which are the above concerns that have led to the third Fridays. Further, the other options from 9:30 a.m. to 4:15 p.m. Eastern time) transition to A.M. settlement for index exchanges close trading in certain will prevent potential pricing derivatives have been largely mitigated. options on the last trading day for divergence that could occur between It believes that expiration pressure in certain classes.22 4:00 p.m. and 4:15 p.m. on the final the underlying cash markets at the close The Exchange has analyzed its trading day in expiring P.M.-settled XSP has been greatly reduced with the capacity and represents that it believes and Weekly/EOM options. Without advent of multiple primary listing and the Exchange and OPRA have the closing expiring contracts at 4:00 p.m., unlisted trading privilege markets, and necessary systems capacity to handle it is foreseeable that Market-Makers that trading is now widely dispersed the additional traffic associated with the would react by widening spreads in among many market centers. listing of P.M.-settled options. The order to compensate for the additional Additionally, the Exchange notes that Exchange believes any additional traffic risk. Therefore, the Exchange believes opening procedures in the 1990s were that may be generated from the that, in order to mitigate potential deemed acceptable to mitigate one-sided introduction of P.M.-settled options will investor confusion and the potential for order flow driven by index option be manageable. The Exchange increased costs to investors, it is expiration and that the New York Stock represents that it has in place adequate appropriate to cease trading in the Exchange and Nasdaq Stock Market, surveillance procedures to monitor expiring P.M.-settled XSP and Weekly/ LLC each use an automated closing trading in these options thereby helping EOM contracts at 4:00 p.m. The cross procedures and has a closing order to ensure the maintenance of a fair and Exchange does not believe the proposed type that facilitates orderly closings. orderly market. change will impact volatility on the These closing procedures on the B. Self-Regulatory Organization’s underlying cash market at the close on exchanges on which the components of Statement on Burden on Competition third Fridays. Further, the other options the S&P 500 Index trade are well- exchanges close trading in certain equipped to mitigate imbalance pressure The Exchange does not believe that options on the last trading day for at the close. In addition, after-hours the proposed rule change will impose certain classes.25 trading now provides market any burden on competition that is not The Exchange believes that the participants with an alternative to help necessary or appropriate in furtherance proposed rule change will relieve any offset market-on-close imbalances.19 of the purposes of the Act. P.M.-settled Other exchanges currently have pilots options would be available for trading burden on, or otherwise promote, that permit P.M.-settled index options 20 on the Exchange to all market competition, as the rules are and Weekly/EOM options.21 participants. The Exchange believes the substantially the same as those of other The proposed rule change to permit proposed rule change will increase the options exchanges, as noted above. transactions on the Exchange in P.M.- variety of listed options to investors, C. Self-Regulatory Organization’s settled XSP and Weekly/EOM options and provide valuable hedge tools to Statement on Comments on the on their last trading day between the investors. The listing of P.M.-settled Proposed Rule Change Received From hours of 9:30 a.m. and 4:00 p.m. Eastern options will enhance competition by Members, Participants, or Others time (as opposed to the normal trading providing investors with an additional hours for non-expiring P.M.-settled XSP investment vehicle, through which The Exchange neither solicited nor and Weekly/EOM options, which are investors can gain and hedge exposure received comments on the proposed to the stocks that compose the rule change. 18 See Securities Exchange Act Release No. 65256 applicable broad-based indexes. (September 2, 2011), 76 FR 55569 (September 9, Additionally, markets participants are 23 See Cboe Options Rule 24.9, Interpretation and 2011) (SR–C2–2011–008) (order approving listing of Policy .14 and Phlx Rule 1101A, Interpretation and SPXPM options on C2); see also Securities welcome to become Members and trade Policy .05. Exchange Act Release No. 81293 (August 2, 2017), at the Exchange if they determine this 24 See Cboe Options Rule 24.9(e); and Phlx Rule 82 FR 151 (August 8, 2017) (SR–Phlx–2017–04) (or 1101A(b)(vii). approving listing of NDXPM options on Phlx). 22 See Cboe Options Rule 24.6, Interpretations 25 See Cboe Options Rule 24.6, Interpretations 19 See id. and Policies .01 (options with Quarterly Index and Policies .01 (options with Quarterly Index 20 See Cboe Options Rule 24.9, Interpretation and Expirations), .03 (Cboe S&P 500 AM/PM Basis Expirations), .03 (Cboe S&P 500 AM/PM Basis Policy .14; and Phlx Rule 1101A, Commentary .05. options), .04 (P.M.-settled SPX options with third options), .04 (P.M.-settled SPX options with third 21 See Cboe Options Rule 24.9(e); and Phlx Rule Friday-of-the-month expiration and P.M.-settled Friday-of-the-month expiration and P.M.-settled 1101A(b)(vii). XSP options), and .05 (MSCI EAFE Index options). XSP options), and .05 (MSCI EAFE Index options).

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III. Date of Effectiveness of the inspection and copying at the principal The text of the proposed rule change Proposed Rule Change and Timing for office of the Exchange. All comments is available on the Exchange’s website at Commission Action received will be posted without change. http://nasdaqphlx.cchwallstreet.com/, Within 45 days of the date of Persons submitting comments are at the principal office of the Exchange, publication of this notice in the Federal cautioned that we do not redact or edit and at the Commission’s Public Register or within such longer period personal identifying information from Reference Room. comment submissions. You should up to 90 days (i) as the Commission may II. Self-Regulatory Organization’s submit only information that you wish designate if it finds such longer period Statement of the Purpose of, and to make available publicly. All to be appropriate and publishes its Statutory Basis for, the Proposed Rule submissions should refer to File reasons for so finding or (ii) as to which Change the Exchange consents, the Commission Number SR–CboeBZX–2018–066, and will: should be submitted on or before In its filing with the Commission, the A. By order approve or disapprove November 20, 2018. Exchange included statements such proposed rule change, or For the Commission, by the Division of concerning the purpose of and basis for B. institute proceedings to determine Trading and Markets, pursuant to delegated the proposed rule change and discussed whether the proposed rule change authority.26 any comments it received on the should be disapproved. Eduardo A. Aleman, proposed rule change. The text of these Assistant Secretary. statements may be examined at the IV. Solicitation of Comments places specified in Item IV below. The [FR Doc. 2018–23624 Filed 10–29–18; 8:45 am] Exchange has prepared summaries, set Interested persons are invited to BILLING CODE 8011–01–P submit written data, views, and forth in sections A, B, and C below, of arguments concerning the foregoing, the most significant aspects of such including whether the proposed rule SECURITIES AND EXCHANGE statements. change is consistent with the Act. COMMISSION A. Self-Regulatory Organization’s Comments may be submitted by any of Statement of the Purpose of, and the following methods: [Release No. 34–84477; File No. SR–Phlx– 2018–62] Statutory Basis for, the Proposed Rule Electronic Comments Change • Self-Regulatory Organizations; Nasdaq 1. Purpose Use the Commission’s internet PHLX LLC; Notice of Filing and comment form (http://www.sec.gov/ Immediate Effectiveness of Proposed The Exchange proposes to delete the rules/sro.shtml); or • Rule Change To Delete Current Rules rules on arbitration, currently under Send an email to rule-comments@ on Arbitration Rule 950, and incorporate by reference sec.gov. Please include File Number SR– the Nasdaq rules on arbitration at CboeBZX–2018–066 on the subject line. October 24, 2018. General 6 of Nasdaq’s rulebook into Paper Comments Pursuant to Section 19(b)(1) of the General 6 of the Exchange’s Rulebook. Securities Exchange Act of 1934 • The Exchange adopted the Current Send paper comments in triplicate (‘‘Act’’),1 and Rule 19b–4 thereunder,2 to Secretary, Securities and Exchange Arbitration Rules to ensure a fair and notice is hereby given that on October efficient manner in which to handle any Commission, 100 F Street NE, 9, 2018, Nasdaq PHLX LLC (‘‘Phlx’’ or Washington, DC 20549–1090. dispute, claim or controversy arising out ‘‘Exchange’’) filed with the Securities of, or in connection with, the business All submissions should refer to File and Exchange Commission (‘‘SEC’’ or of any Member of the Exchange. To help Number SR-CboeBZX–2018–066. This ‘‘Commission’’) the proposed rule administer the process of dispute file number should be included on the change as described in Items I, II, and resolution, the Exchange and FINRA are subject line if email is used. To help the III, below, which Items have been parties to a Regulatory Contract, Commission process and review your prepared by the Exchange. The pursuant to which FINRA has agreed to comments more efficiently, please use Commission is publishing this notice to perform certain functions and provide only one method. The Commission will solicit comments on the proposed rule access to certain services, including: post all comments on the Commission’s change from interested persons. Member regulation and registration; internet website (http://www.sec.gov/ I. Self-Regulatory Organization’s non-real time market surveillance; rules/sro.shtml). Copies of the examinations and investigations; and submission, all subsequent Statement of the Terms of Substance of the Proposed Rule Change dispute resolution. FINRA currently amendments, all written statements operates the largest securities dispute with respect to the proposed rule The Exchange proposes to delete the resolution forum in the United States,4 change that are filed with the current rules on arbitration (‘‘Current and has given the Exchange access to Commission, and all written Arbitration Rules’’), under Rule 950, these services. Under the Current communications relating to the and incorporate by reference The Arbitration Rules, Members and proposed rule change between the Nasdaq Stock Market LLC’s (‘‘Nasdaq’’) associated persons of a Member are Commission and any person, other than rules on arbitration at General 6 subject to the FINRA Code of those that may be withheld from the (‘‘Proposed Arbitration Rules’’), into Arbitration Procedure. public in accordance with the General 6 of the Exchange’s rulebook’s provisions of 5 U.S.C. 552, will be (‘‘Rulebook’’) shell structure.3 Nasdaq Stock Market LLC; Nasdaq BX, Inc.; Nasdaq available for website viewing and ISE, LLC; Nasdaq GEMX, LLC; and Nasdaq MRX, printing in the Commission’s Public 26 17 CFR 200.30–3(a)(12). LLC (‘‘Affiliated Exchanges’’). The shell structure Reference Room, 100 F Street NE, 1 15 U.S.C. 78s(b)(1). currently contains eight (8) Chapters which, once Washington, DC 20549, on official 2 17 CFR 240.19b–4. complete, will apply a common set of rules to the 3 Recently, the Exchange added a shell structure Affiliated Exchanges. See Securities Exchange Act business days between the hours of to its Rulebook with the purpose of improving Release No. 82169 (November 29, 2017), 82 FR 10:00 a.m. and 3:00 p.m. Copies of the efficiency and readability and to align its rules 57508 (December 5, 2017) (SR–PHLX–2017–97). filing also will be available for closer to those of its five sister exchanges, The 4 http://www.finra.org/arbitration-and-mediation.

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Because the Affiliated Exchanges are perfect the mechanism of a free and public interest, for the protection of also parties to similar Regulatory open market and a national market investors, or otherwise in furtherance of Contracts with FINRA that make their system, and, in general to protect the purposes of the Act. If the members and associated persons of such investors and the public interest, by Commission takes such action, the members subject to the FINRA Code of promoting efficiency and structural Commission shall institute proceedings Arbitration Procedure, the Exchange conformity of the Exchange’s processes to determine whether the proposed rule believes it is pertinent that a common with those of the Affiliated Exchanges should be approved or disapproved. set of rules on arbitration be included in and to make the Exchange’s Rulebook the General section of the Rulebook’s easier to read and more accessible to its IV. Solicitation of Comments shell. Nasdaq completed this process Members. The Exchange believes that Interested persons are invited to recently 5 and, pursuant to subsequent the adoption and harmonization of the submit written data, views, and filings, the intention is to replace the arbitration rules and cross-reference arguments concerning the foregoing, existing arbitration rules for each of the updates are of a non-substantive nature. including whether the proposed rule Affiliated Exchanges by incorporating B. Self-Regulatory Organization’s change is consistent with the Act. the Nasdaq rules on arbitration by Statement on Burden on Competition Comments may be submitted by any of reference. the following methods: Therefore, the Exchange will The Exchange does not believe that incorporate by reference the Proposed the proposed rule change will impose Electronic Comments Arbitration Rules in ‘‘General 6 any burden on competition not • Use the Commission’s internet Arbitration’’ of the shell’s ‘‘General necessary or appropriate in furtherance comment form (http://www.sec.gov/ Equity and Options Rules’’ section. of the purposes of the Act. The rules/sro.shtml); or The relocation and harmonization of proposed changes do not impose a • Send an email to rule-comments@ the arbitration rules is part of the burden on competition because, as sec.gov. Please include File Number SR– Exchange’s continued effort to promote previously stated, they are (i) of a non- Phlx–2018–62 on the subject line. efficiency and conformity of its substantive nature, (ii) intended to processes with those of its Affiliated harmonize the structure of the Paper Comments Exchanges.6 The Exchange believes that Exchange’s rules with those of its • Send paper comments in triplicate the adoption and placement of the Affiliated Exchanges, and (iii) intended to Secretary, Securities and Exchange Proposed Arbitration Rules to their new to organize the Rulebook in a way that Commission, 100 F Street NE, location in the shell will facilitate the it will ease the Members’ navigation and Washington, DC 20549–1090. use of the Rulebook by Members of the reading of the rules across the Affiliated All submissions should refer to File Exchange who are members of other Exchanges. Number SR–Phlx–2018–62. This file Affiliated Exchanges. Moreover, the C. Self-Regulatory Organization’s number should be included on the proposed changes are of a conforming Statement on Comments on the subject line if email is used. To help the nature and will not amend the Proposed Rule Change Received From Commission process and review your substance of the adopted rules other Members, Participants, or Others comments more efficiently, please use than to update the language to that of only one method. The Commission will No written comments were either the Proposed Arbitration Rules, and to post all comments on the Commission’s solicited or received. make conforming cross-reference internet website (http://www.sec.gov/ changes. III. Date of Effectiveness of the rules/sro.shtml). PHLX will continue to file proposed Proposed Rule Change and Timing for Copies of the submission, all rule changes to amend its General 6 Commission Action subsequent amendments, all written Rules until such time as it receives an Because the foregoing proposed rule statements with respect to the proposed exemption from the Securities and change does not: (i) Significantly affect rule change that are filed with the Exchange Commission, pursuant to its the protection of investors or the public Commission, and all written authority under Section 36 of the interest; (ii) impose any significant communications relating to the Exchange Act of 1934 (‘‘Act’’) and Rule burden on competition; and (iii) become proposed rule change between the 0–12 7 thereunder, from the Section operative for 30 days from the date on Commission and any person, other than 19(b) filing requirements to separately which it was filed, or such shorter time those that may be withheld from the file a proposed rule change to amend as the Commission may designate, it has public in accordance with the General 6. become effective pursuant to Section provisions of 5 U.S.C. 552, will be 2. Statutory Basis 19(b)(3)(A)(iii) of the Act 10 and available for website viewing and subparagraph (f)(6) of Rule 19b–4 The Exchange believes that its printing in the Commission’s Public thereunder.11 Reference Room, 100 F Street NE, proposal is consistent with Section 6(b) At any time within 60 days of the 8 Washington, DC 20549, on official of the Act, in general, and furthers the filing of the proposed rule change, the 9 business days between the hours of 10 objectives of Section 6(b)(5) of the Act, Commission summarily may in particular, in that it is designed to a.m. and 3 p.m. Copies of the filing also temporarily suspend such rule change if will be available for inspection and promote just and equitable principles of it appears to the Commission that such trade, to remove impediments to and copying at the principal office of the action is necessary or appropriate in the Exchange. All comments received will 5 See Securities Exchange Act Release No. 83834 be posted without change. Persons 10 15 U.S.C. 78s(b)(3)(A)(iii). (August 13, 2018), 83 FR 41115 (August 17, 2018) submitting comments are cautioned that 11 17 CFR 240.19b–4(f)(6). In addition, Rule 19b– (SR–NASDAQ–2018–067). we do not redact or edit personal 6 4(f)(6) requires a self-regulatory organization to give See footnote 3. the Commission written notice of its intent to file identifying information from comment 7 See 17 CFR 240.0–12; Securities Exchange Act the proposed rule change at least five business days Release No. 39624 (February 5, 1998), 63 FR 8101 submissions. You should submit only prior to the date of filing of the proposed rule information that you wish to make (February 18, 1998). change, or such shorter time as designated by the 8 15 U.S.C. 78f(b). Commission. The Exchange has satisfied this available publicly. All submissions 9 15 U.S.C. 78f(b)(5). requirement. should refer to File Number SR–Phlx–

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2018–62 and should be submitted on or Percent DATES: Please send your comments by before November 20, 2018. November 29, 2018. OMB must receive Non-Profit Organizations with For the Commission, by the Division of your comments by this date in order to Credit Available Elsewhere 2.500 Trading and Markets, pursuant to delegated act quickly on the ICR. Non-Profit Organizations authority.12 without Credit Available ADDRESSES: All comments should Eduardo A. Aleman, Elsewhere ...... 2.500 reference Federal Docket Management Assistant Secretary. For Economic Injury: System (FDMS) Docket Number [FR Doc. 2018–23621 Filed 10–29–18; 8:45 am] Non-Profit Organizations FMCSA–2018–0159. Interested persons BILLING CODE 8011–01–P without Credit Available are invited to submit written comments Elsewhere...... 2.500 on the proposed information collection to the Office of Information and The number assigned to this disaster SMALL BUSINESS ADMINISTRATION Regulatory Affairs, Office of for physical damage is 157808 and for Management and Budget. Comments [Disaster Declaration # 15780 and # 15781; economic injury is 157810. should be addressed to the attention of FLORIDA Disaster Number FL–00141] the Desk Officer, Department of (Catalog of Federal Domestic Assistance Transportation/Federal Motor Carrier Presidential Declaration of a Major Number 59008) Safety Administration, and sent via Disaster for Public Assistance Only for electronic mail to oira_submission@ the State of Florida Rafaela Monchek, Acting Associate Administrator for Disaster omb.eop.gov, or faxed to (202) 395– AGENCY: U.S. Small Business Assistance. 6974, or mailed to the Office of Administration. [FR Doc. 2018–23626 Filed 10–29–18; 8:45 am] Information and Regulatory Affairs, Office of Management and Budget, ACTION: Notice. BILLING CODE 8025–01–P Docket Library, Room 10102, 725 17th SUMMARY: This is a Notice of the Street NW, Washington, DC 20503. Presidential declaration of a major FOR FURTHER INFORMATION CONTACT: Mr. disaster for Public Assistance Only for DEPARTMENT OF TRANSPORTATION Selden Fritschner, Senior the State of Florida (FEMA–4399–DR), Transportation Specialist, Office of dated 10/23/2018. Federal Motor Carrier Safety Administration Safety Programs, Commercial Driver’s Incident: Hurricane Michael. License Division (MC–ESL), Department Incident Period: 10/07/2018 through [Docket No. FMCSA–2018–0159] of Transportation, Federal Motor Carrier 10/19/2018. Safety Administration, 6th Floor, West DATES: Issued on 10/23/2018. Agency Information Collection Building, 1200 New Jersey Avenue SE, Physical Loan Application Deadline Activities; Revision of an Approved Washington, DC 20590–0001. Date: 12/24/2018. Information Collection Request: Telephone: 202–366–0677; Email Economic Injury (EIDL) Loan Commercial Driver Licensing and Test Address: [email protected]. Application Deadline Date: 07/23/2019. Standards Office hours are from 9 a.m. to 5 p.m., ADDRESSES: Submit completed loan Monday through Friday, except Federal AGENCY: Federal Motor Carrier Safety Holidays. applications to: U.S. Small Business Administration (FMCSA), DOT. Administration, Processing and SUPPLEMENTARY INFORMATION: Disbursement Center, 14925 Kingsport ACTION: Notice and request for comments. Title: Commercial Driver Licensing Road, Fort Worth, TX 76155. and Test Standards. FOR FURTHER INFORMATION CONTACT: A. SUMMARY: In accordance with the OMB Control Number: 2126–0011. Escobar, Office of Disaster Assistance, Paperwork Reduction Act of 1995, Type of Request: Revision of a U.S. Small Business Administration, FMCSA announces its plan to submit currently-approved information 409 3rd Street SW, Suite 6050, the Information Collection Request (ICR) collection. Washington, DC 20416, (202) 205–6734. described below to the Office of Respondents: Drivers with a SUPPLEMENTARY INFORMATION: Notice is Management and Budget (OMB) for commercial learner’s permit (CLP) or hereby given that as a result of the review and approval. FMCSA requests commercial driver’s license (CDL) and President’s major disaster declaration on approval to revise and renew an ICR State driver licensing agencies. 10/23/2018, Private Non-Profit titled, ‘‘Commercial Driver Licensing Estimated Number of Respondents: organizations that provide essential and Test Standards,’’ due to, in part, a 7,364,972 driver respondents and 4,746 services of a governmental nature may decrease in the number of commercial State respondents. file disaster loan applications at the driver’s license records and the addition Estimated Time per Response: Varies. address listed above or other locally of one information collection item: Expiration Date: October 31, 2018. announced locations. ‘‘Driver completion of knowledge and Frequency of Response: Varies. The following areas have been skills tests.’’ This ICR is needed to determined to be adversely affected by ensure that drivers, motor carriers and Estimated Total Annual Burden: the disaster: the States are complying with 2,825,503 hours, which is the total of four tasks for CDL drivers (2,403,248 Primary Counties: Bay, Calhoun, notification and recordkeeping requirements for information related to hours), added to a total of eight tasks for Gadsden, Gulf, Jackson, Liberty. State driver licensing agency CDL The Interest Rates are: testing, licensing, violations, convictions and disqualifications and activities (422,255 hours). Information collection tasks and Percent that the information is accurate, complete and transmitted and recorded associated burden hours are as follows: For Physical Damage: within certain time periods as required IC–1.1 Driver Notification of by the Commercial Motor Vehicle Safety Convictions/Disqualifications to 12 17 CFR 200.30–3(a)(12). Act of 1986 (CMVSA), as amended. Employer: 473,577 hours

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IC–1.2 Driver Providing Previous usefulness, and clarity of the collected internet, you may view the docket Employment History to New information; and (4) ways that the online by visiting the Docket Employer: 297,758 hours burden could be minimized without Management Facility in Room W12–140 IC–1.3 Driver Completion of the CDL reducing the quality of the collected on the ground floor of the DOT West Application Form: 40,719 hours information. Building, 1200 New Jersey Avenue SE, IC–1.4 Driver Completion of Knowledge Issued under the authority delegated in 49 Washington, DC 20590, between 9 a.m. and Skills Tests: 1,591,194 hours CFR 1.87 on: October 24, 2018 and 5 p.m., ET, Monday through Friday, IC–2.1 State Recording of Medical G. Kelly Regal, except Federal holidays. Examiner’s Certificate Information: 80,344 hours Associate Administrator for Office of B. Privacy Act Research and Information Technology. IC–2.2 State Recording of the Self In accordance with 5 U.S.C. 553(c), [FR Doc. 2018–23707 Filed 10–29–18; 8:45 am] Certification of Commercial Motor DOT solicits comments from the public Vehicle (CMV) Operation: 3,018 hours BILLING CODE 4910–EX–P to better inform its rulemaking process. IC–2.3 State Verification of Medical DOT posts these comments, without Certification Status: 3,180 hours DEPARTMENT OF TRANSPORTATION edit, including any personal information IC–2.4 Annual State Certification of the commenter provides, to Compliance: 1,632 hours Federal Motor Carrier Safety www.regulations.gov, as described in IC–2.5 State Preparing for and Administration the system of records notice (DOT/ALL– Participating in Annual Program 14 FDMS), which can be reviewed at Review: 10,200 hours [Docket No. FMCSA–2018–0014] www.dot.gov/privacy. IC–2.6 CDLIS/PDPS/State Recordkeeping: 214,548 hours Qualification of Drivers; Exemption II. Background IC–2.7 Knowledge and Skills Test Applications; Vision On July 17, 2018, FMCSA published Recordkeeping: 82,034 hours AGENCY: Federal Motor Carrier Safety a notice announcing receipt of IC–2.8 Knowledge and Skills Test Administration (FMCSA), DOT. applications from 13 individuals Examiner Certification: 27,299 hours ACTION: Notice of final disposition. requesting an exemption from vision Background: The licensed drivers in requirement in 49 CFR 391.41(b)(10) the United States deserve reasonable SUMMARY: FMCSA announces its and requested comments from the assurance that their fellow motorists are decision to exempt 13 individuals from public (83 FR 33292). The public properly qualified to drive the vehicles the vision requirement in the Federal comment period ended on August 16, they operate. Before the Commercial Motor Carrier Safety Regulations 2018, and no comments were received. Motor Vehicle Safety Act of 1986 (FMCSRs) to operate a commercial FMCSA has evaluated the eligibility (CMVSA or the Act) Public Law 99–570, motor vehicle (CMV) in interstate of these applicants and determined that Title XII, 100 Stat. 3207, codified at 49 commerce. They are unable to meet the granting the exemptions to these U.S.C. chapter 313) was signed by the vision requirement in one eye for individuals would achieve a level of President on October 27, 1986, 18 States various reasons. The exemptions enable safety equivalent to or greater than the and the District of Columbia authorized these individuals to operate CMVs in level that would be achieved by any person licensed to drive an interstate commerce without meeting complying with the current regulation automobile to also legally drive a large the vision requirement in one eye. 49 CFR 391.41(b)(10). truck or bus. No special training or DATES: The exemptions were applicable The physical qualification standard special license was required to drive on August 17, 2018. The exemptions for drivers regarding vision found in 49 these vehicles, even though it was expire on August 17, 2020. CFR 391.41(b)(10) states that a person is widely recognized that operation of FOR FURTHER INFORMATION CONTACT: Ms. physically qualified to driver a CMV if certain types of vehicles called for Christine A. Hydock, Chief, Medical that person has distant visual acuity of special skills, knowledge and training. Programs Division, (202) 366–4001, at least 20/40 (Snellen) in each eye Even in the 32 States that had a [email protected], FMCSA, without corrective lenses or visual classified driver licensing system in Department of Transportation, 1200 acuity separately corrected to 20/40 place, only 12 of these States required New Jersey Avenue SE, Room W64–224, (Snellen) or better with corrective an applicant to take a skills test in a Washington, DC 20590–0001. Office lenses, distant binocular acuity of a least representative vehicle. Equally serious hours are from 8:30 a.m. to 5 p.m., ET, 20/40 (Snellen) in both eyes with or was the problem of drivers possessing Monday through Friday, except Federal without corrective lenses, field of vision multiple driver licenses. By spreading ° holidays. If you have questions of at least 70 in the horizontal meridian their convictions among several States, regarding viewing or submitting in each eye, and the ability to recognize CMV drivers could avoid punishment material to the docket, contact Docket the colors of traffic signals and devices for their infringements, and stay behind Services, telephone (202) 366–9826. showing red, green, and amber. the wheel. For a detailed history of regulatory SUPPLEMENTARY INFORMATION: III. Discussion of Comments developments in 49 CFR parts 383 and I. Public Participation FMCSA received no comments in this 384 to implement the mandates in the proceeding. CMVSA, see the supporting statement in A. Viewing Documents and Comments the docket for this matter.’’ To view comments, as well as any IV. Basis for Exemption Determination Public Comments Invited: You are documents mentioned in this notice as Under 49 U.S.C. 31136(e) and 31315, asked to comment on any aspect of this being available in the docket, go to FMCSA may grant an exemption for up information collection, including: (1) http://www.regulations.gov. Insert the to five years from the vision standard in Whether the proposed collection is docket number, FMCSA–2018–0014, in 49 CFR 391.41(b)(10) if the exemption is necessary for the FMCSA to perform its the keyword box, and click ‘‘Search.’’ likely to achieve an equivalent or greater functions; (2) the accuracy of the Next, click the ‘‘Open Docket Folder’’ level of safety than would be achieved estimated burden; (3) ways for the button and choose the document to without the exemption. The exemption FMCSA to enhance the quality, review. If you do not have access to the allows applicants to operate CMVs in

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interstate commerce. FMCSA grants them are more compact. These 391.41(b)(10), subject to the exemptions from the FMCSRs for a two- conditions tax visual capacity and requirements cited above: year period to align with the maximum driver response just as intensely as Ronald D. Blakely (MI) duration of a driver’s medical interstate driving conditions. Homero Dominguez (TX) certification. The applicants in this notice have Larry L. George (LA) The Agency’s decision regarding these driven CMVs with their limited vision Jason C. Hetrick (PA) exemption applications is based on in careers ranging for 4 to 78 years. In Michael A. Hildebrand (PA) medical reports about the applicants’ the past three years, no drivers were Junior M. Isenberg (KY) vision as well as their driving records involved in crashes, and one driver was David G. Livingston (VT) and experience driving with the vision convicted of a moving violation in a Joseph P. Markley (PA) deficiency. The qualifications, CMV. All the applicants achieved a Derek L. Redford (ID) experience, and medical condition of record of safety while driving with their David Tavarez (NJ) each applicant were stated and vision impairment, demonstrating the William B. Van Drielen (NV) discussed in detail in the July 17, 2018, likelihood that they have adapted their Willie R. White, Jr. (NV) Federal Register notice (83 FR 33292) driving skills to accommodate their Curtis C. Williams (MO) and will not be repeated in this notice. condition. As the applicants’ ample In accordance with 49 U.S.C. 31136(e) FMCSA recognizes that some drivers driving histories with their vision and 31315, each exemption will be valid do not meet the vision requirement but deficiencies are good predictors of for two years from the effective date have adapted their driving to future performance, FMCSA concludes unless revoked earlier by FMCSA. The accommodate their limitation and their ability to drive safely can be exemption will be revoked if the demonstrated their ability to drive projected into the future. following occurs: (1) The person fails to safely. The 13 exemption applicants Consequently, FMCSA finds that in comply with the terms and conditions listed in this notice are in this category. each case exempting these applicants of the exemption; (2) the exemption has They are unable to meet the vision from the vision requirement in 49 CFR resulted in a lower level of safety than requirement in one eye for various 391.41(b)(10) is likely to achieve a level was maintained prior to being granted; reasons, including amblyopia, complete of safety equal to that existing without or (3) continuation of the exemption loss of vision, corneal scar, irregularly the exemption. would not be consistent with the goals shaped pupil, macular myelinated nerve V. Conditions and Requirements and objectives of 49 U.S.C. 31136 and fibers, macular scar, optic nerve 31315. damage, posterior staphyloma, The terms and conditions of the prosthetic eye, and retinal detachment. exemption are provided to the Issued on: October 24, 2018. In most cases, their eye conditions were applicants in the exemption document Larry W. Minor, not recently developed. Nine of the and includes the following: (1) Each Associate Administrator for Policy. applicants were either born with their driver must be physically examined [FR Doc. 2018–23706 Filed 10–29–18; 8:45 am] vision impairments or have had them every year (a) by an ophthalmologist or BILLING CODE 4910–EX–P since childhood. The four individuals optometrist who attests that the vision that sustained their vision conditions as in the better eye continues to meet the adults have had it for a range of 6 to 18 standard in 49 CFR 391.41(b)(10) and (b) DEPARTMENT OF TRANSPORTATION years. Although each applicant has one by a certified Medical Examiner who Federal Railroad Administration eye which does not meet the vision attests that the individual is otherwise requirement in 49 CFR 391.41(b)(10), physically qualified under 49 CFR [Docket No. FRA–2018–0008–N–10] each has at least 20/40 corrected vision 391.41; (2) each driver must provide a in the other eye, and in a doctor’s copy of the ophthalmologist’s or Proposed Agency Information opinion, has sufficient vision to perform optometrist’s report to the Medical Collection Activities; Comment all the tasks necessary to operate a CMV. Examiner at the time of the annual Request Doctors’ opinions are supported by medical examination; and (3) each AGENCY: Federal Railroad the applicants’ possession of a valid driver must provide a copy of the license to operate a CMV. By meeting Administration (FRA), Department of annual medical certification to the Transportation (DOT). State licensing requirements, the employer for retention in the driver’s ACTION: applicants demonstrated their ability to qualification file, or keep a copy in his/ Notice of information collection; operate a CMV, with their limited vision her driver’s qualification file if he/she is request for comment. in intrastate commerce, even though self-employed. The driver must also their vision disqualified them from SUMMARY: Under the Paperwork have a copy of the exemption when Reduction Act of 1995 (PRA), this notice driving in interstate commerce. We driving, for presentation to a duly believe that the applicants’ intrastate announces that FRA is forwarding the authorized Federal, State, or local Information Collection Requests (ICRs) driving experience and history provide enforcement official. an adequate basis for predicting their abstracted below to the Office of ability to drive safely in interstate VI. Preemption Management and Budget (OMB) for review and comment. The ICRs describe commerce. Intrastate driving, like During the period the exemption is in the information collections and their interstate operations, involves effect, no State shall enforce any law or expected burden. On August 1, 2018, substantial driving on highways on the regulation that conflicts with this FRA published a notice providing a 60- interstate system and on other roads exemption with respect to a person day period for public comment on the built to interstate standards. Moreover, operating under the exemption. driving in congested urban areas ICRs. exposes the driver to more pedestrian VII. Conclusion DATES: Interested persons are invited to and vehicular traffic than exists on Based upon its evaluation of the 13 submit comments on or before interstate highways. Faster reaction to exemption applications, FMCSA November 29, 2018. traffic and traffic signals is generally exempts the following drivers from the ADDRESSES: Submit written comments required because distances between vision requirement, 49 CFR on the ICRs to the Office of Information

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and Regulatory Affairs, Office of FRA to enhance the quality, utility, and CFR part 236 that results in a more Management and Budget, 725 17th clarity of the information being favorable aspect than intended) or other Street NW, Washington, DC 20503, collected; and (4) ways to minimize the condition hazardous to the movement of Attention: FRA Desk Officer. Comments burden of information collection a train. Section 233.7 provides that each may also be sent via email to OMB at activities on the public, including the railroad must report signal failures the following address: oira_ use of automated collection techniques within 15 days in accordance with the [email protected]. or other forms of information instructions printed on Form FRA F FOR FURTHER INFORMATION CONTACT: Mr. technology. 6180.14. Robert Brogan, Information Collection The summaries below describe the Title 49 CFR part 235 sets forth the Clearance Officer, Office of Railroad ICRs that FRA will submit for OMB specific conditions under which FRA Safety, Regulatory Analysis Division, clearance as the PRA requires: will approve the modification or RRS–21, Federal Railroad Title: Railroad Locomotive Safety discontinuance of railroad signal Administration, 1200 New Jersey Standards and Event Recorders. systems. These regulations also describe Avenue SE, Room W33–497, OMB Control Number: 2130–0004. the process that should be followed by Washington, DC 20590 (telephone: (202) Abstract: The Locomotive Safety a railroad to seek such an approval. The 493–6292); or Ms. Kim Toone, Standards at 49 CFR part 229 require application process prescribed under 49 Information Collection Clearance railroads to inspect, repair, and CFR part 235 enables FRA to obtain the Officer, Office of Administration, Office maintain locomotives, including their necessary information to make logical of Information Technology, RAD–20, event recorders, to ensure they are safe and informed decisions concerning Federal Railroad Administration, 1200 and free of defects. Crashworthy railroad requests to modify or New Jersey Avenue SE, Room W34–212, locomotive event recorders provide FRA discontinue signaling systems. Section Washington, DC 20590 (telephone: (202) with verifiable factual information about 235.5 requires railroads to apply for 493–6132). how trains are operated. These devices FRA approval to discontinue or are used by FRA and State inspectors for materially modify railroad signal SUPPLEMENTARY INFORMATION: The PRA, systems. However, section 235.7 cites 44 U.S.C. 3501–3520, and its part 229 rule enforcement. The information garnered from crashworthy signal system changes that do not implementing regulations, 5 CFR part require FRA approval such as removal 1320, require Federal agencies to issue event recorders is used by railroads to monitor railroad operations and by of an interlocking where a drawbridge two notices seeking public comment on has been permanently closed by the information collection activities before railroad employees (locomotive engineers, train crews, dispatchers) to formal approval of another OMB may approve paperwork packages. governmental agency. Section 235.8 See 44 U.S.C. 3506, 3507; 5 CFR 1320.8 improve train handling, and promote the safe and efficient operation of trains allows railroads to seek relief from the through 1320.12. On August 1, 2018, requirements in 49 CFR part 236. FRA published a 60-day notice in the throughout the country, based on a surer knowledge of different control inputs. Sections 235.10, 235.12, and 235.13 Federal Register soliciting comment on explain where the application must be the ICRs for which it is now seeking Type of Request: Extension with change of a current information submitted, what information must be OMB approval. See 83 FR 37606. FRA included, what the format should be, received no comments in response to collection. Affected Public: Businesses and who is authorized to sign the this notice. application. FRA provides public notice (railroads). Before OMB decides whether to concerning applications for relief and Form(s): FRA F 6180.49A. approve these proposed collections of allows individuals and organizations to Respondent Universe: 741 Railroads. information, it must provide 30 days for protest the granting of an application for Frequency of Submission: On public comment. Federal law requires relief. Section 235.20 describes the occasion. OMB to approve or disapprove protest process, including essential Total Estimated Annual Responses: paperwork packages between 30 and 60 information that must accompany the 7,509,648. days after the 30-day notice is protest, the address for filing the protest, Total Estimated Annual Burden: published. 44 U.S.C. 3507(b)–(c); 5 CFR the time limit for filing the protest, and 3,815,751 hours. 1320.12(d); see also 60 FR 44978, 44983, the requirement that a person requesting Aug. 29, 1995. OMB believes the 30-day Title: Railroad Signal System a public hearing explain why written notice informs the regulated community Requirements. statements cannot be used to explain his to file relevant comments and affords OMB Control Number: 2130–0006. or her position. the agency adequate time to digest Abstract: The regulations pertaining Title 49 CFR part 236 contains FRA’s public comments before it renders a to railroad signal systems are contained signal system requirements. Section decision. 60 FR 44983, Aug. 29, 1995. in 49 CFR parts 233 (Signal System 236.110 requires that the results of Therefore, respondents should submit Reporting Requirements), 235 signal system tests required under their respective comments to OMB (Instructions Governing Applications for §§ 236.102 through 236.109; 236.376 within 30 days of publication to best Approval of a Discontinuance or through 236.387; 236.576 and 236.577; ensure having their full effect. Material Modification of a Signal and 236.586 through 236.589 be Comments are invited on the System), and 236 (Rules, Standards, and recorded on pre-printed forms provided following ICRs regarding: (1) Whether Instructions Governing the Installation, by the railroad or by electronic means, the information collection activities are Inspection, Maintenance, and Repair of subject to FRA approval. These forms necessary for FRA to properly execute Signal and Train Control Systems, show the name of the railroad, place its functions, including whether the Devices, and Appliances). Section 233.5 and date of the test conducted, type of information will have practical utility; provides that each railroad must report equipment tested, and results of the test. (2) the accuracy of FRA’s estimates of to FRA within 24 hours after learning of They also describe any repairs, the burden of the information collection an accident or incident arising from replacements, and adjustments activities, including the validity of the signal failure (e.g., failure of a signal performed on the equipment that has methodology and assumptions used to appliance, device, method or system to been tested, and the condition in which determine the estimates; (3) ways for function or indicate as required by 49 the equipment was left. This section

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also requires that the employee development or implementation of more DEPARTMENT OF TRANSPORTATION conducting the test must sign the form efficient railroad transportation and that the record be retained at the equipment or other transportation Maritime Administration office of the supervisory official. Test innovations, the applicable section of [Docket No. MARAD–2018–0158] results made in compliance with the Rock Island Act, currently codified § 236.587 must be retained for 92 days. at 49 U.S.C. 20306, provides the Requested Administrative Waiver of The results of all other tests required Secretary of Transportation with the the Coastwise Trade Laws: Vessel under §§ 236.102 through 109; 236.376 authority to grant an exemption to those YEMAYA; Invitation for Public through 236.387; 236.576 and 236.577; requirements based on evidence Comments and 236.586 through 236.589, including received and findings developed at a results of periodic tests, must be hearing. In accordance with that statute, AGENCY: Maritime Administration, DOT. retained until the next record is filed, FRA held a public hearing and invoked ACTION: Notice. but no less than one year. Additionally, its discretionary authority under 49 § 236.587 requires each railroad to make U.S.C. 20306 to provide a limited SUMMARY: The Secretary of a departure test of the cab signal, exemption from 49 U.S.C. 20303 for Transportation, as represented by the automatic train stop, or train control freight trains and freight cars operating Maritime Administration (MARAD), is devices on locomotives prior to a with electronically controlled authorized to grant waivers of the U.S.- locomotive entering equipped territory. pneumatic (ECP) brake systems. In build requirements of the coastwise This section further requires that doing so, FRA revised the regulations trade laws to allow the carriage of no whoever performs the departure test governing freight power brakes and more than twelve passengers for hire on must certify in writing that the test was equipment in October 2008 by adding a vessels, which are three years old or properly performed. The certification new subpart G. The revisions are more. A request for such a waiver has and test results must be posted in the designed to provide for and encourage been received by MARAD. The vessel, locomotive cab with a copy of the the safe implementation and use of ECP and a brief description of the proposed certification and test results retained at brake system technologies. These service, is listed below. the office of the supervisory official. revisions contain specific requirements DATES: Submit comments on or before However, if it is impractical to leave a on the design, interoperability, training, November 29, 2018. copy of the certification and test results inspection, testing, handling of ADDRESSES: You may submit comments at the location where the test is defective equipment, and periodic identified by DOT Docket Number conducted, then the test results must be maintenance related to ECP brake MARAD–2018–0158 by any one of the transmitted to either the dispatcher or systems. The final rule also provides following methods: another designated official who must flexibility to facilitate the voluntary • Federal eRulemaking Portal: Go to keep a written record of the test results adoption of this advanced brake system http://www.regulations.gov. Search and the name of the person performing technology. The collection of MARAD–2018–2018–0158 and follow the test. All records prepared under this information is used by FRA to monitor the instructions for submitting section are required to be retained for 92 and enforce regulatory requirements comments. days. Finally, § 236.590 requires related to power brakes on freight cars, • Mail or Hand Delivery: Docket railroads to clean and inspect the including the requirements related to Management Facility is in the West pneumatic apparatus of automatic train ECP brake systems. The collection of Building, Ground Floor of the U.S. stop, train control, or cab signal devices information is also used by locomotive Department of Transportation. The on locomotives as required by engineers and road crews to verify that Docket Management Facility location § 229.29(a). the terminal air brake test has been address is: U.S. Department of Type of Request: Extension with performed in a satisfactory manner. Transportation, MARAD–2018–0158, change of a currently approved Type of Request: Extension with 1200 New Jersey Avenue SE, West information collection. change of a currently approved Building, Room W12–140, Washington, Affected Public: Businesses. information collection. DC 20590, between 9 a.m. and 5 p.m., Form(s): FRA F 6180.14. Affected Public: Businesses. Monday through Friday, except on Respondent Universe: 741 Railroads. Form(s): N/A. Federal holidays. Respondent Universe: 741 Railroads. Frequency of Submission: On Frequency of Submission: On Note: If you mail or hand-deliver your occasion. occasion. comments, we recommend that you Total Estimated Annual Responses: Total Estimated Annual Responses: include your name and a mailing 1,673,437. 30,518,808. address, an email address, or a Total Estimated Annual Burden: Total Estimated Annual Burden: telephone number in the body of your 444,820 hours. 1,045,478 hours. document so that we can contact you if Title: Inspection Brake System Safety Under 44 U.S.C. 3507(a) and 5 CFR we have questions regarding your Standards for Freight and Other Non- 1320.5(b) and 1320.8(b)(3)(vi), FRA submission. Passenger Trains and Equipment (Power informs all interested parties that it may Instructions: All submissions received Brakes). not conduct or sponsor, and a must include the agency name and OMB Control Number: 2130–0008. respondent is not required to respond specific docket number. All comments Abstract: Recognizing the importance to, a collection of information unless it received will be posted without change of upgrading rail technologies, Congress displays a currently valid OMB control to the docket at www.regulations.gov, in 1980 passed the Rock Island Railroad number. including any personal information provided. For detailed instructions on Transition and Employee Assistance Act Authority: 44 U.S.C. 3501–3520. (the ‘‘Rock Island Act’’), which, inter submitting comments, see the section alia, provides statutory relief for the Juan D. Reyes III, entitled Public Participation. implementation of new technologies. Chief Counsel. FOR FURTHER INFORMATION CONTACT: More specifically, when certain [FR Doc. 2018–23586 Filed 10–29–18; 8:45 am] Bianca Carr, U.S. Department of statutory requirements preclude the BILLING CODE 4910–06–P Transportation, Maritime

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Administration, 1200 New Jersey identifying information, will be made build requirements of the coastwise Avenue SE, Room W23–453, publicly available. trade laws to allow the carriage of no Washington, DC 20590. Telephone 202– more than twelve passengers for hire on May I submit comments confidentially? 366–9309, Email [email protected]. vessels, which are three years old or SUPPLEMENTARY INFORMATION: As If you wish to submit comments more. A request for such a waiver has described by the applicant the intended under a claim of confidentiality, you been received by MARAD. The vessel, service of the vessel YEMAYA is: should submit three copies of your and a brief description of the proposed —Intended Commercial Use of Vessel: complete submission, including the service, is listed below. ‘‘Bareboat charters’’ information you claim to be confidential DATES: Submit comments on or before —Geographic Region Including Base of business information, to the Department November 29, 2018. Operations: ‘‘Michigan, Illinois’’ (Base of Transportation, Maritime ADDRESSES: You may submit comments of Operations: Holland, MI) Administration, Office of Legislation identified by DOT Docket Number —Vessel Length and Type: 60′ Arduman and Regulations, MAR–225, W24–220, MARAD–2018–0161 by any one of the motor with twin diesel Caterpillar 1200 New Jersey Avenue SE, following methods: engines Washington, DC 20590. Include a cover • Federal eRulemaking Portal: Go to The complete application is available letter setting forth with specificity the http://www.regulations.gov. Search for review identified in the DOT docket basis for any such claim and, if possible, MARAD–2018–0161 and follow the as MARAD–2018–0158 at http:// a summary of your submission that can instructions for submitting comments. www.regulations.gov. Interested parties be made available to the public. • Mail or Hand Delivery: Docket may comment on the effect this action Privacy Act Management Facility is in the West may have on U.S. vessel builders or Building, Ground Floor of the U.S. In accordance with 5 U.S.C. 553(c), businesses in the U.S. that use U.S.-flag Department of Transportation. The DOT solicits comments from the public vessels. If MARAD determines, in Docket Management Facility location to better inform its rulemaking process. accordance with 46 U.S.C. 12121 and address is: U.S. Department of DOT posts these comments, without MARAD’s regulations at 46 CFR part Transportation, MARAD–2018–0161, edit, to www.regulations.gov, as 388, that the issuance of the waiver will 1200 New Jersey Avenue SE, West described in the system of records have an unduly adverse effect on a U.S.- Building, Room W12–140, Washington, notice, DOT/ALL–14 FDMS, accessible vessel builder or a business that uses DC 20590, between 9 a.m. and 5 p.m., through www.dot.gov/privacy. To U.S.-flag vessels in that business, a Monday through Friday, except on facilitate comment tracking and waiver will not be granted. Comments Federal holidays. response, we encourage commenters to should refer to the vessel name, state the Note: If you mail or hand-deliver your provide their name, or the name of their commenter’s interest in the waiver comments, we recommend that you organization; however, submission of application, and address the waiver include your name and a mailing names is completely optional. Whether criteria given in section 388.4 of address, an email address, or a or not commenters identify themselves, MARAD’s regulations at 46 CFR part telephone number in the body of your all timely comments will be fully 388. document so that we can contact you if considered. If you wish to provide we have questions regarding your Public Participation comments containing proprietary or submission. confidential information, please contact How do I submit comments? Instructions: All submissions received the agency for alternate submission must include the agency name and Please submit your comments, instructions. specific docket number. All comments including the attachments, following the Authority: 49 CFR 1.93(a), 46 U.S.C. 55103, received will be posted without change instructions provided under the above 46 U.S.C. 12121 to the docket at www.regulations.gov, heading entitled ADDRESSES. Be advised * * * * * including any personal information that it may take a few hours or even provided. For detailed instructions on days for your comment to be reflected Dated: October 25, 2018. submitting comments, see the section on the docket. In addition, your By Order of the Maritime Administrator. entitled Public Participation. comments must be written in English. T. Mitchell Hudson, Jr., FOR FURTHER INFORMATION CONTACT: We encourage you to provide concise Secretary, Maritime Administration. Bianca Carr, U.S. Department of comments and you may attach [FR Doc. 2018–23650 Filed 10–29–18; 8:45 am] Transportation, Maritime additional documents as necessary. BILLING CODE 4910–81–P Administration, 1200 New Jersey There is no limit on the length of the Avenue SE, Room W23–453, attachments. Washington, DC 20590. Telephone 202– Where do I go to read public comments, DEPARTMENT OF TRANSPORTATION 366–9309, Email [email protected]. and find supporting information? Maritime Administration SUPPLEMENTARY INFORMATION: As Go to the docket online at http:// described by the applicant the intended www.regulations.gov, keyword search [Docket No. MARAD–2018–0161] service of the vessel Y KNOT is: —Intended Commercial Use of Vessel: MARAD–2018–0158 or visit the Docket Requested Administrative Waiver of Carrying small groups of passengers Management Facility (see ADDRESSES for the Coastwise Trade Laws: Vessel Y for hire under private charter hours of operation). We recommend that KNOT; Invitation for Public Comments you periodically check the Docket for —Geographic Region Including Base of new submissions and supporting AGENCY: Maritime Administration, DOT. Operations: ‘‘Florida, New York material. ACTION: Notice. (excluding New York Harbor)’’ (Base of Operations: Miami, Florida.) Will my comments be made available to SUMMARY: The Secretary of —Vessel Length and Type: 68’ Leopard the public? Transportation, as represented by the motor vessel Yes. Be aware that your entire Maritime Administration (MARAD), is The complete application is available comment, including your personal authorized to grant waivers of the U.S.- for review identified in the DOT docket

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as MARAD–2018–0161 at http:// a summary of your submission that can MARAD–2018–0162 and follow the www.regulations.gov. Interested parties be made available to the public. instructions for submitting comments. may comment on the effect this action • Privacy Act Mail or Hand Delivery: Docket may have on U.S. vessel builders or Management Facility is in the West businesses in the U.S. that use U.S.-flag In accordance with 5 U.S.C. 553(c), Building, Ground Floor of the U.S. vessels. If MARAD determines, in DOT solicits comments from the public Department of Transportation. The accordance with 46 U.S.C. 12121 and to better inform its rulemaking process. Docket Management Facility location MARAD’s regulations at 46 CFR part DOT posts these comments, without address is: U.S. Department of 388, that the issuance of the waiver will edit, to www.regulations.gov, as Transportation, MARAD–2018–0162, have an unduly adverse effect on a U.S.- described in the system of records 1200 New Jersey Avenue SE, West vessel builder or a business that uses notice, DOT/ALL–14 FDMS, accessible Building, Room W12–140, Washington, U.S.-flag vessels in that business, a through www.dot.gov/privacy. To DC 20590, between 9 a.m. and 5 p.m., waiver will not be granted. Comments facilitate comment tracking and Monday through Friday, except on should refer to the vessel name, state the response, we encourage commenters to Federal holidays. commenter’s interest in the waiver provide their name, or the name of their Note: If you mail or hand-deliver your application, and address the waiver organization; however, submission of comments, we recommend that you criteria given in section 388.4 of names is completely optional. Whether include your name and a mailing MARAD’s regulations at 46 CFR part or not commenters identify themselves, address, an email address, or a 388. all timely comments will be fully telephone number in the body of your considered. If you wish to provide Public Participation document so that we can contact you if comments containing proprietary or we have questions regarding your How do I submit comments? confidential information, please contact submission. the agency for alternate submission Instructions: All submissions received Please submit your comments, instructions. including the attachments, following the must include the agency name and instructions provided under the above Authority: 49 CFR 1.93(a), 46 U.S.C. 55103, specific docket number. All comments 46 U.S.C. 12121. heading entitled ADDRESSES. Be advised received will be posted without change that it may take a few hours or even * * * * * to the docket at www.regulations.gov, days for your comment to be reflected Dated: October 25, 2018. including any personal information on the docket. In addition, your By Order of the Maritime Administrator. provided. For detailed instructions on submitting comments, see the section comments must be written in English. T. Mitchell Hudson, Jr., entitled Public Participation. We encourage you to provide concise Secretary, Maritime Administration. comments and you may attach FOR FURTHER INFORMATION CONTACT: [FR Doc. 2018–23655 Filed 10–29–18; 8:45 am] additional documents as necessary. Bianca Carr, U.S. Department of BILLING CODE 4910–81–P There is no limit on the length of the Transportation, Maritime attachments. Administration, 1200 New Jersey Avenue SE, Room W23–453, Where do I go to read public comments, DEPARTMENT OF TRANSPORTATION Washington, DC 20590. Telephone 202– and find supporting information? Maritime Administration 366–9309, Email [email protected]. Go to the docket online at http:// [Docket No. MARAD–2018–0162] SUPPLEMENTARY INFORMATION: As www.regulations.gov. keyword search described by the applicant the intended MARAD–2018–0161 or visit the Docket Requested Administrative Waiver of service of the vessel ONE LOVE is: Management Facility (see ADDRESSES for the Coastwise Trade Laws: Vessel —Intended Commercial Use of Vessel: hours of operation). We recommend that ONE LOVE; Invitation for Public ‘‘Charter Boat’’ you periodically check the Docket for Comments new submissions and supporting —Geographic Region Including Base of material. AGENCY: Maritime Administration, DOT. Operations: ‘‘Florida’’ (Base of Operations: Key Largo, Florida) ACTION: Notice. Will my comments be made available to —Vessel Length and Type: 40′ fixed keel the public? SUMMARY: The Secretary of catamaran sailing vessel Yes. Be aware that your entire Transportation, as represented by the The complete application is available comment, including your personal Maritime Administration (MARAD), is for review identified in the DOT docket identifying information, will be made authorized to grant waivers of the U.S.- as MARAD–2018–0162 at http:// publicly available. build requirements of the coastwise www.regulations.gov. Interested parties trade laws to allow the carriage of no may comment on the effect this action May I submit comments confidentially? more than twelve passengers for hire on may have on U.S. vessel builders or If you wish to submit comments vessels, which are three years old or businesses in the U.S. that use U.S.-flag under a claim of confidentiality, you more. A request for such a waiver has vessels. If MARAD determines, in should submit three copies of your been received by MARAD. The vessel, accordance with 46 U.S.C. 12121 and complete submission, including the and a brief description of the proposed MARAD’s regulations at 46 CFR part information you claim to be confidential service, is listed below. 388, that the issuance of the waiver will business information, to the Department DATES: Submit comments on or before have an unduly adverse effect on a U.S.- of Transportation, Maritime November 29, 2018. vessel builder or a business that uses Administration, Office of Legislation ADDRESSES: You may submit comments U.S.-flag vessels in that business, a and Regulations, MAR–225, W24–220, identified by DOT Docket Number waiver will not be granted. Comments 1200 New Jersey Avenue SE, MARAD–2018–0162 by any one of the should refer to the vessel name, state the Washington, DC 20590. Include a cover following methods: commenter’s interest in the waiver letter setting forth with specificity the • Federal eRulemaking Portal: Go to application, and address the waiver basis for any such claim and, if possible, http://www.regulations.gov. Search criteria given in section 388.4 of

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MARAD’s regulations at 46 CFR part all timely comments will be fully telephone number in the body of your 388. considered. If you wish to provide document so that we can contact you if comments containing proprietary or we have questions regarding your Public Participation confidential information, please contact submission. How do I submit comments? the agency for alternate submission Instructions: All submissions received Please submit your comments, instructions. must include the agency name and including the attachments, following the Authority: 49 CFR 1.93(a), 46 U.S.C. specific docket number. All comments instructions provided under the above § 55103, 46 U.S.C. § 12121. received will be posted without change heading entitled ADDRESSES. Be advised * * * * * to the docket at www.regulations.gov, including any personal information that it may take a few hours or even Dated: October 25, 2018. days for your comment to be reflected provided. For detailed instructions on By Order of the Maritime Administrator. on the docket. In addition, your submitting comments, see the section comments must be written in English. T. Mitchell Hudson, Jr., entitled Public Participation. We encourage you to provide concise Secretary, Maritime Administration. FOR FURTHER INFORMATION CONTACT: comments and you may attach [FR Doc. 2018–23656 Filed 10–29–18; 8:45 am] Bianca Carr, U.S. Department of additional documents as necessary. BILLING CODE 4910–81–P Transportation, Maritime There is no limit on the length of the Administration, 1200 New Jersey attachments. Avenue SE, Room W23–453, DEPARTMENT OF TRANSPORTATION Where do I go to read public comments, Washington, DC 20590. Telephone 202– 366–9309, Email [email protected]. and find supporting information? Maritime Administration SUPPLEMENTARY INFORMATION: As Go to the docket online at http:// [Docket No. MARAD–2018–0160] described by the applicant the intended www.regulations.gov., keyword search service of the vessel MACONDO is: MARAD–2018–0162 or visit the Docket Requested Administrative Waiver of Management Facility (see ADDRESSES for the Coastwise Trade Laws: Vessel —Intended Commercial Use of Vessel: hours of operation). We recommend that MACONDO; Invitation for Public Vessel will be used for recreational you periodically check the Docket for Comments sailing charters including sunset new submissions and supporting cruises, day sails, and overnight AGENCY: material. Maritime Administration, DOT. excursions upon the waters of Marina ACTION: Notice. del Rey and Santa Monica Bay from Will my comments be made available to Paradise Cove to Santa Catalina the public? SUMMARY: The Secretary of Island, California. The majority of the Transportation, as represented by the Yes. Be aware that your entire time the boat operation will be within Maritime Administration (MARAD), is comment, including your personal 10 nautical miles of Marina del Rey. identifying information, will be made authorized to grant waivers of the U.S.- The area of operation is Santa Monica publicly available. build requirements of the coastwise Bay and on occasion, the boat would trade laws to allow the carriage of no travel to Santa Catalina Island. May I submit comments confidentially? more than twelve passengers for hire on —Geographic Region Including Base of If you wish to submit comments vessels, which are three years old or Operations: ‘‘California’’ (Base of under a claim of confidentiality, you more. A request for such a waiver has Operations: Marina del Rey, CA) should submit three copies of your been received by MARAD. The vessel, —Vessel Length and Type: 47.6′ fixed- complete submission, including the and a brief description of the proposed keel, single mast, sloop rig sailboat service, is listed below. information you claim to be confidential The complete application is available DATES: Submit comments on or before business information, to the Department for review identified in the DOT docket November 29, 2018. of Transportation, Maritime as MARAD–2018–0160 at http:// Administration, Office of Legislation ADDRESSES: You may submit comments www.regulations.gov. Interested parties and Regulations, MAR–225, W24–220, identified by DOT Docket Number may comment on the effect this action 1200 New Jersey Avenue SE, MARAD–2018–0160 by any one of the may have on U.S. vessel builders or Washington, DC 20590. Include a cover following methods: • businesses in the U.S. that use U.S.-flag letter setting forth with specificity the Federal eRulemaking Portal: Go to vessels. If MARAD determines, in basis for any such claim and, if possible, http://www.regulations.gov. Search accordance with 46 U.S.C. 12121 and a summary of your submission that can MARAD–2018–0160 and follow the MARAD’s regulations at 46 CFR part be made available to the public. instructions for submitting comments. 388, that the issuance of the waiver will • Mail or Hand Delivery: Docket have an unduly adverse effect on a U.S.- Privacy Act Management Facility is in the West vessel builder or a business that uses In accordance with 5 U.S.C. 553(c), Building, Ground Floor of the U.S. U.S.-flag vessels in that business, a DOT solicits comments from the public Department of Transportation. The waiver will not be granted. Comments to better inform its rulemaking process. Docket Management Facility location should refer to the vessel name, state the DOT posts these comments, without address is: U.S. Department of commenter’s interest in the waiver edit, to www.regulations.gov, as Transportation, MARAD–2018–0160, application, and address the waiver described in the system of records 1200 New Jersey Avenue SE, West criteria given in section 388.4 of notice, DOT/ALL–14 FDMS, accessible Building, Room W12–140, Washington, MARAD’s regulations at 46 CFR part through www.dot.gov/privacy. To DC 20590, between 9 a.m. and 5 p.m., 388. facilitate comment tracking and Monday through Friday, except on response, we encourage commenters to Federal holidays. Public Participation provide their name, or the name of their Note: If you mail or hand-deliver your organization; however, submission of comments, we recommend that you How do I submit comments? names is completely optional. Whether include your name and a mailing Please submit your comments, or not commenters identify themselves, address, an email address, or a including the attachments, following the

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instructions provided under the above (Authority: 49 CFR 1.93(a), 46 U.S.C. 55103, specific docket number. All comments heading entitled ADDRESSES. Be advised 46 U.S.C. 12121) received will be posted without change that it may take a few hours or even * * * * * to the docket at www.regulations.gov, days for your comment to be reflected including any personal information on the docket. In addition, your Dated: October 25, 2018. provided. For detailed instructions on comments must be written in English. By Order of the Maritime Administrator. submitting comments, see the section We encourage you to provide concise T. Mitchell Hudson, Jr., entitled Public Participation. comments and you may attach Secretary, Maritime Administration. FOR FURTHER INFORMATION CONTACT: additional documents as necessary. [FR Doc. 2018–23654 Filed 10–29–18; 8:45 am] Bianca Carr, U.S. Department of There is no limit on the length of the BILLING CODE 4910–81–P attachments. Transportation, Maritime Administration, 1200 New Jersey Where do I go to read public comments, DEPARTMENT OF TRANSPORTATION Avenue SE, Room W23–453, and find supporting information? Washington, DC 20590. Telephone 202– Go to the docket online at http:// Maritime Administration 366–9309, Email [email protected]. www.regulations.gov, keyword search [Docket No. MARAD–2018–0159] SUPPLEMENTARY INFORMATION: As MARAD–2018–0160 or visit the Docket described by the applicant the intended Management Facility (see ADDRESSES for Requested Administrative Waiver of service of the vessel SHANGHAI MAC hours of operation). We recommend that the Coastwise Trade Laws: Vessel is: you periodically check the Docket for SHANGHAI MAC; Invitation for Public new submissions and supporting Comments —Intended Commercial Use of Vessel: material. ‘‘Day charter cruises along the Napa AGENCY: Maritime Administration, DOT. River.’’ Will my comments be made available to ACTION: Notice. the public? —Geographic Region Including Base of SUMMARY: The Secretary of Operations: ‘‘California’’ (Base of Yes. Be aware that your entire Transportation, as represented by the Operations: Vallejo Marina in Vallejo, comment, including your personal Maritime Administration (MARAD), is CA) identifying information, will be made authorized to grant waivers of the U.S.- —Vessel Length and Type: 70′6″ Azimut publicly available. build requirements of the coastwise Motor boat May I submit comments confidentially? trade laws to allow the carriage of no more than twelve passengers for hire on The complete application is available If you wish to submit comments vessels, which are three years old or for review identified in the DOT docket under a claim of confidentiality, you more. A request for such a waiver has as MARAD–2018–0159 at http:// should submit three copies of your been received by MARAD. The vessel, www.regulations.gov. Interested parties complete submission, including the and a brief description of the proposed may comment on the effect this action information you claim to be confidential service, is listed below. may have on U.S. vessel builders or business information, to the Department DATES: Submit comments on or before businesses in the U.S. that use U.S.-flag of Transportation, Maritime November 29, 2018. vessels. If MARAD determines, in accordance with 46 U.S.C. 12121 and Administration, Office of Legislation ADDRESSES: You may submit comments and Regulations, MAR–225, W24–220, identified by DOT Docket Number MARAD’s regulations at 46 CFR part 1200 New Jersey Avenue SE, MARAD–2018–0159 by any one of the 388, that the issuance of the waiver will Washington, DC 20590. Include a cover following methods: have an unduly adverse effect on a U.S.- letter setting forth with specificity the • Federal eRulemaking Portal: Go to vessel builder or a business that uses basis for any such claim and, if possible, http://www.regulations.gov. Search U.S.-flag vessels in that business, a a summary of your submission that can MARAD–2018–0159 and follow the waiver will not be granted. Comments be made available to the public. instructions for submitting comments. should refer to the vessel name, state the • commenter’s interest in the waiver Privacy Act Mail or Hand Delivery: Docket Management Facility is in the West application, and address the waiver In accordance with 5 U.S.C. 553(c), Building, Ground Floor of the U.S. criteria given in section 388.4 of DOT solicits comments from the public Department of Transportation. The MARAD’s regulations at 46 CFR part to better inform its rulemaking process. Docket Management Facility location 388. DOT posts these comments, without address is: U.S. Department of Public Participation edit, to www.regulations.gov, as Transportation, MARAD–2018–0159, described in the system of records 1200 New Jersey Avenue SE, West How do I submit comments? notice, DOT/ALL–14 FDMS, accessible Building, Room W12–140, Washington, through www.dot.gov/privacy. To DC 20590, between 9 a.m. and 5 p.m., Please submit your comments, facilitate comment tracking and Monday through Friday, except on including the attachments, following the response, we encourage commenters to Federal holidays. instructions provided under the above provide their name, or the name of their Note: If you mail or hand-deliver your heading entitled ADDRESSES. Be advised organization; however, submission of comments, we recommend that you that it may take a few hours or even names is completely optional. Whether include your name and a mailing days for your comment to be reflected or not commenters identify themselves, address, an email address, or a on the docket. In addition, your all timely comments will be fully telephone number in the body of your comments must be written in English. considered. If you wish to provide document so that we can contact you if We encourage you to provide concise comments containing proprietary or we have questions regarding your comments and you may attach confidential information, please contact submission. additional documents as necessary. the agency for alternate submission Instructions: All submissions received There is no limit on the length of the instructions. must include the agency name and attachments.

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Where do I go to read public comments, DEPARTMENT OF THE TREASURY money laundering, the counterfeiting of and find supporting information? goods or currency, bulk cash smuggling, Office of Foreign Assets Control narcotics trafficking, or other illicit economic Go to the docket online at http:// activity that involves or supports the www.regulations.gov., keyword search Notice of OFAC Sanctions Actions Government of North Korea or any senior MARAD–2018–0159 or visit the Docket official thereof. AGENCY: Office of Foreign Assets Management Facility (see ADDRESSES for Entities hours of operation). We recommend that Control, Treasury. you periodically check the Docket for ACTION: Notice. 1. WEE TIONG (S) PTE LTD (a.k.a. WEE TIONG S PTE LTD), 1813 Geylang Bahru, new submissions and supporting SUMMARY: The Department of the #01–01 Kallang Distripark 339715, material. Treasury’s Office of Foreign Assets Singapore; 64D Kallang Pudding Road, #02– Will my comments be made available to Control (OFAC) is publishing the names 00, Wee Tiong Building 349323, Singapore; 02–00 Wee Tiong Building, 64D, Kallang the public? of one or more persons and vessels that have been placed on OFAC’s Specially Pudding Road 349323, Singapore; 1805 Yes. Be aware that your entire Geylang Bahru #01–03 339711, Singapore; Designated Nationals and Blocked Secondary sanctions risk: North Korea comment, including your personal Persons List based on OFAC’s Sanctions Regulations, sections 510.201 and identifying information, will be made determination that one or more 510.210; Registration Number 199308567K publicly available. applicable legal criteria were satisfied. [DPRK]. May I submit comments confidentially? All property and interests in property Designated pursuant to Section 1(a)(ii)(D) subject to U.S. jurisdiction of these E.O. 13551 for having directly or indirectly, If you wish to submit comments persons and these vessels are blocked, engaged in money laundering, the counterfeiting of goods or currency, bulk under a claim of confidentiality, you and U.S. persons are generally prohibited from engaging in transactions cash smuggling, narcotics trafficking, or other should submit three copies of your illicit economic activity that involves or complete submission, including the with them. supports the Government of North Korea or information you claim to be confidential DATES: See SUPPLEMENTARY INFORMATION any senior official thereof. business information, to the Department section. 2. WT MARINE PTE LTD, #11–09 Parkway of Transportation, Maritime FOR FURTHER INFORMATION CONTACT: Parade 449269, Singapore; 64D Kallang Administration, Office of Legislation OFAC: Associate Director for Global Pudding Road, #09–00 Wee Tiong Building 349323, Singapore; Secondary sanctions risk: and Regulations, MAR–225, W24–220, Targeting, tel.: 202–622–2420; Assistant 1200 New Jersey Avenue SE, North Korea Sanctions Regulations, sections Director for Sanctions Compliance & 510.201 and 510.210; Registration Number Washington, DC 20590. Include a cover Evaluation, tel.: 202–622–2490; 201616714Z [DPRK]. letter setting forth with specificity the Assistant Director for Licensing, tel.: Designated pursuant to Section 1(a)(ii)(D) basis for any such claim and, if possible, 202–622–2480; or the Department of the of E.O. 13551 for having directly or a summary of your submission that can Treasury’s Office of the General indirectly, engaged in money laundering, the be made available to the public. Counsel: Office of the Chief Counsel counterfeiting of goods or currency, bulk cash smuggling, narcotics trafficking, or other Privacy Act (Foreign Assets Control), tel.: 202–622– 2410. illicit economic activity that involves or supports the Government of North Korea or In accordance with 5 U.S.C. 553(c), SUPPLEMENTARY INFORMATION: any senior official thereof. DOT solicits comments from the public to better inform its rulemaking process. Electronic Availability Vessels DOT posts these comments, without The Specially Designated Nationals 1. NYMEX STAR Singapore flag; edit, to www.regulations.gov, as and Blocked Persons List and additional Secondary sanctions risk: North Korea described in the system of records information concerning OFAC sanctions Sanctions Regulations, sections 510.201 and notice, DOT/ALL–14 FDMS, accessible programs are available on OFAC’s 510.210; Vessel Registration Identification through www.dot.gov/privacy. To website (www.treasury.gov/ofac). IMO 9078191 (vessel) [DPRK] (Linked To: facilitate comment tracking and WT MARINE PTE LTD). Notice of OFAC Actions response, we encourage commenters to Identified pursuant to E.O. 13551 as provide their name, or the name of their On October 25, 2018, OFAC property in which WT MARINE PTE LTD, an determined that the property and entity whose property and interests in organization; however, submission of property are blocked pursuant to E.O. 13551, names is completely optional. Whether interests in property subject to U.S. has an interest. or not commenters identify themselves, jurisdiction of the following persons 2. JW JEWEL Singapore flag; Secondary all timely comments will be fully and the following vessels subject to U.S. sanctions risk: North Korea Sanctions considered. If you wish to provide jurisdiction are blocked pursuant to the Regulations, sections 510.201 and 510.210; comments containing proprietary or relevant sanctions authority listed Vessel Registration Identification IMO confidential information, please contact below. 9402964 (vessel) [DPRK] (Linked To: WT MARINE PTE LTD). the agency for alternate submission Individual instructions. Identified pursuant to E.O. 13551 as 1. TAN, Wee Beng, 51 Siang Kuang property in which WT MARINE PTE LTD, an (Authority: 49 CFR 1.93(a), 46 U.S.C. § 55103, Avenue, Singapore; DOB 14 Feb 1977; entity whose property and interests in 46 U.S.C. § 12121) Gender Male; Secondary sanctions risk: property are blocked pursuant to E.O. 13551, * * * * * North Korea Sanctions Regulations, sections has an interest. 510.201 and 510.210; Director of Wee Tiong Dated: October 25, 2018. Additionally, on October 25, 2018, (S) Pte Ltd; Managing Director of WT Marine OFAC updated the entries on the By Order of the Maritime Administrator. Pte Ltd (individual) [DPRK]. Specially Designated Nationals and T. Mitchell Hudson, Jr., Designated pursuant to Section 1(a)(ii)(D) of Executive Order 13551 of August 30, 2010, Blocked Persons List for the following Secretary, Maritime Administration. ‘‘Blocking Property of Certain Persons With individuals, whose property and [FR Doc. 2018–23651 Filed 10–29–18; 8:45 am] Respect to North Korea’’ (E.O. 13551) for interests in property are subject to U.S. BILLING CODE 4910–81–P having directly or indirectly, engaged in jurisdiction and who continue to be

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blocked under the relevant sanctions DEPARTMENT OF THE TREASURY Estimated Number of Respondents: authorities listed below. 655. Agency Information Collection Frequency of Response: Quarterly. Individuals Activities; Submission for OMB Estimated Total Number of Annual 1. OWHADI, Mohammad Ebrahim (a.k.a. Review; Comment Request; Multiple Responses: 9,725. OWHADI, Jalal; a.k.a. TAHERI, Jalal; a.k.a. IRS Information Collection Requests Estimated Time per Response: 6 VAHEDI, Jalal), Iran; DOB 1963; Gender Male minutes. AGENCY: Departmental Offices, U.S. Estimated Total Annual Burden (individual) [SDGT] (Linked To: ISLAMIC Department of the Treasury. REVOLUTIONARY GUARD CORPS (IRGC)– Hours: 978. QODS FORCE; Linked To: TALIBAN). ACTION: Notice. Title: Form 8801—Credit for Prior 1. OWHADI, Mohammad Ebrahim (a.k.a. Year Minimum Tax—Individuals, SUMMARY: The Department of the OWHADI, Jalal; a.k.a. TAHERI, Jalal; a.k.a. Estates and Trusts. Treasury will submit the following OMB Control Number: 1545–1073. VAHEDI, Jalal), Iran; DOB 1963; Additional information collection requests to the Sanctions Information—Subject to Secondary Type of Review: Extension without Office of Management and Budget Sanctions; Gender Male (individual) [SDGT] change of a currently approved (OMB) for review and clearance in [IRGC] [IFSR] (Linked To: ISLAMIC collection. accordance with the Paperwork REVOLUTIONARY GUARD CORPS (IRGC)– Description: Form 8801 is used by Reduction Act of 1995, on or after the QODS FORCE; Linked To: TALIBAN). individuals, estates, and trusts to date of publication of this notice. The compute the minimum tax credit, if any, Designated on October 23, 2018 public is invited to submit comments on available from a tax year beginning after pursuant to section 1(c) of E.O. 13224 these requests. 1986 to be used in the current year or for acting for or on behalf of the DATES: Comments should be received on to be carried forward for use in a future ISLAMIC REVOLUTIONARY GUARD or before November 29, 2018 to be year. CORPS–QODS FORCE (IRGC–QF), a assured of consideration. Form: 8801. person determined to be subject to E.O. ADDRESSES: Send comments regarding Affected Public: Businesses or other 13224, and pursuant to section 1(d)(i) of the burden estimate, or any other aspect for-profits. E.O. 13224 for assisting in, sponsoring, of the information collection, including Estimated Number of Respondents: or providing financial, material, or suggestions for reducing the burden, to 38,744. technological support for, or financial or (1) Office of Information and Regulatory Frequency of Response: Annually. other services to or in support of, the Affairs, Office of Management and Estimated Total Number of Annual Responses: 12,914. TALIBAN, a person determined to be Budget, Attention: Desk Officer for Estimated Time per Response: 7.06 subject to E.O. 13224. Treasury, New Executive Office Building, Room 10235, Washington, DC hours per response. 2. RAZAVI, Esma’il (a.k.a. MOHAJERI, 20503, or email at OIRA_Submission@ Estimated Total Annual Burden Mostafa), Iran; DOB 1959; Gender Male OMB.EOP.gov and (2) Treasury PRA Hours: 91,173. (individual) [SDGT] (Linked To: ISLAMIC Clearance Officer, 1750 Pennsylvania Title: Qualified Separate Lines of REVOLUTIONARY GUARD CORPS (IRGC)– Ave. NW, Suite 8100, Washington, DC Business. QODS FORCE; Linked To: TALIBAN). 20220, or email at [email protected]. OMB Control Number: 1545–1221. -to- Type of Review: Extension without FOR FURTHER INFORMATION CONTACT: change of a currently approved 2. RAZAVI, Esma’il (a.k.a. MOHAJERI, Copies of the submissions may be collection. Mostafa), Iran; DOB 1959; Additional obtained from Jennifer Leonard by Description: The affected public Sanctions Information—Subject to Secondary emailing [email protected], calling includes employers who maintain Sanctions; Gender Male (individual) [SDGT] (202) 622–0489, or viewing the entire qualified employee retirement plans. [IRGC] [IFSR] (Linked To: ISLAMIC information collection request at Where applicable, the employer must REVOLUTIONARY GUARD CORPS (IRGC)– www.reginfo.gov. QODS FORCE; Linked To: TALIBAN). furnish notice to the IRS that the SUPPLEMENTARY INFORMATION: employer treats itself as operating Designated on October 23, 2018 Internal Revenue Service (IRS) qualified separate lines of business and pursuant to section 1(c) of E.O. 13224 some may request an IRS determination for acting for or on behalf of the IRGC– Title: FI–27–89 (Temporary and Final) that such lines satisfy administrative QF, a person determined to be subject Real Estate Mortgage Investment scrutiny. to E.O. 13224, and pursuant to section Conduits; Reporting Requirements and Form: None. 1(d)(i) of E.O. 13224 for assisting in, Other Administrative Matters; FI–61–91 Affected Public: Businesses or other sponsoring, or providing financial, (Final) Allocation of Allocable for-profits. material, or technological support for, or Investment. Estimated Number of Respondents: financial or other services to or in OMB Control Number: 1545–1018. 125. support of, the TALIBAN, a person Type of Review: Extension without Frequency of Response: Annually. change of a currently approved Estimated Total Number of Annual determined to be subject to E.O. 13224. collection. Responses: 125. Dated: October 25, 2018. Description: These previously Estimated Time per Response: 3.55 Andrea M. Gacki, approved regulations prescribe the hours per response. Director, Office of Foreign Assets Control. manner in which an entity elects to be Estimated Total Annual Burden Hours: 444. [FR Doc. 2018–23659 Filed 10–29–18; 8:45 am] taxed as a real estate mortgage investment conduit (REMIC) and the Title: TD 8395—Special Valuation BILLING CODE 4810–AL–P filing requirements for REMICs and Rules. certain brokers. OMB Control Number: 1545–1241. Form: None. Type of Review: Extension without Affected Public: Businesses or other change of a currently approved for-profits. collection.

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Description: Section 2701 of the Type of Review: Extension without facsimile signature of the returns Internal Revenue Code allows various change of a currently approved preparer. elections by family members who make collection. Form: None. gifts of common stock or partnership Description: This document contains Affected Public: Businesses or other interests and retain senior interest. The previously approved final regulations for-profits. elections affect the value of the gifted relating to joint returns, property Estimated Number of Respondents: interests and the retained interests. This exempt from levy, interest, penalties, 20,000. document contains final regulations offers in compromise, and the awarding Frequency of Response: Annually. relating to chapter 14 of the Internal of costs and certain fees. The regulations Estimated Total Number of Annual Revenue Code as enacted in the reflect changes to the law made by the Responses: 20,000. Omnibus Budget Reconciliation Act of Taxpayer Bill of Rights 2 and a Estimated Time per Response: 1.2 1990, Public Law 101–508, 104 Stat. conforming amendment made by the hours per response. 1388. These previously approved Personal Responsibility and Work Estimated Total Annual Burden regulations provide special valuation Opportunity Reconciliation Act of 1996. Hours: 24,000. rules for purposes of Federal estate and The regulations affect taxpayers with Title: Third-Party Disclosure gift taxes imposed under chapter 1 and respect to filing of returns, interest, Requirements in the IRS Regulations. 12 of the Code. In addition, these penalties, court costs, and payment, OMB Control Number: 1545–1466. regulations provide rules involving deposit, and collection of taxes. Type of Review: Revision of a lapsing rights and other transactions Form: None. currently approved collection. that are treated as completed transfers Affected Public: Individuals or Description: Taxpayers must obtain under chapter 14. Households. third-party certification or Form: None. Estimated Number of Respondents: documentation to avail themselves of Affected Public: Individuals or 38. certain credits, deductions or other Households. Frequency of Response: On Occasion. benefits permitted by the Internal Revenue Code. Taxpayers will use these Estimated Number of Respondents: Estimated Total Number of Annual documents or information to support 1,200. Responses: 38. claims for certain credits, deductions or Frequency of Response: Annually. Estimated Time per Response: 2.26 hours per response. tax benefits on their returns. The Estimated Total Number of Annual Service may review these documents or Responses: 1,200. Estimated Total Annual Burden Hours: 86. information during any examination of Estimated Time per Response: .41 taxpayers’ returns to verify the Title: Qualified Electric Vehicle hours per response. taxpayers’ entitlement to the claimed Credit. Estimated Total Annual Burden credits, deductions or tax benefits. This Hours: 496. OMB Control Number: 1545–1374. Type of Review: Extension without submission contains third-party Title: TD 8513—Bad Debt Reserves of disclosure regulations subject to the Banks. change of a currently approved collection. Paperwork Reduction Act of 1995. OMB Control Number: 1545–1290. Form: None. Description: Form 8834 is used to Type of Review: Extension without Affected Public: Businesses or other claim any qualified electric vehicle change of a currently approved for-profits. passive activity credit allowed for the collection. Estimated Number of Respondents: current tax. The data on Form 8834 will Description: Section 585(c) of the 245,073,905. be used to determine that the credit is Frequency of Response: .53342215 Internal Revenue Code requires large allowable and that it has been properly banks to change from the reserve responses annually. computed. Estimated Total Number of Annual method of accounting to the specific Form: 8834. charge off method of accounting for bad Responses: 130,727, 849. Affected Public: Businesses or other Estimated Time per Response: .26 debts. The information required by for-profits. section 1.585–8 of the regulations hours per response. Estimated Number of Respondents: Estimated Total Annual Burden identifies any election made or revoked 3,136. by the taxpayer in accordance with Hours: 33,931,750. Frequency of Response: Annually. Title: Electronic Federal Tax Payment section 585(c). Estimated Total Number of Annual Form: None. System (EFTPS). Responses: 3,136. OMB Control Number: 1545–1467. Affected Public: Businesses or other Estimated Time per Response: 4.79 for-profits. Type of Review: Extension without hours per response. change of a currently approved Estimated Number of Respondents: Estimated Total Annual Burden 2,500. collection. Hours: 15,022. Description: Enrollment is vital to the Frequency of Response: Annually. Title: TD 8549 (Final) Preparer implementation of the Electronic Estimated Total Number of Annual Penalties—Manual Signature Federal Tax Payment System (EFTPS). Responses: 2,500. Requirement. EFTPS is an electronic remittance Estimated Time per Response: .25 OMB Control Number: 1545–1385. processing system that the Service will hours per response. Type of Review: Extension without use to accept electronically transmitted Estimated Total Annual Burden change of a currently approved federal tax payments. This system is a Hours: 625. collection. necessary outgrowth of advanced Title: TD 8725—Miscellaneous Description: The reporting information and communication Sections Affected by the Taxpayer Bill requirements affect return preparers of technologies. of Rights 2 and the Personal fiduciary returns. They will be required Forms: 9783, 9779, 14781, 9787, and Responsibility and Work Opportunity to submit a list of the names and 9789. Reconciliation Act of 1996. identifying numbers of all fiduciary Affected Public: Businesses or other OMB Control Number: 1545–1356. returns which are being filed with a for-profits.

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Estimated Number of Respondents: OMB Control Number: 1545–1648. Description: This document contains 4,350,000. Type of Review: Extension without previously approved final regulations Frequency of Response: On occasion. change of a currently approved that provide guidance on the reporting Estimated Total Number of Annual collection. requirements for interest on deposits Responses: 4,350,000. Description: Publication 3319 is the maintained at the U.S. office of certain Estimated Time per Response: .17 grant application and program financial institutions and paid to hours per response. requirements for our external customers, nonresident alien individuals. These Estimated Total Annual Burden non-profits, legal aid societies, regulations affect persons making Hours: 755,192. universities, law schools, and will be payments of interest with respect to Title: Distributions from an Archer used by anyone in the US and territories such a deposit. MSA or Medicare + Choice MSA. to apply for a low income taxpayer Form: None. OMB Control Number: 1545–1517. grant. There is a website, which collects Affected Public: Businesses or other Type of Review: Extension without the information. for-profit. change from a currently approved Form: None. Estimated Number of Respondents: collection. Affected Public: Not-for-profit- 2,000. Description: This form is used to institutions. Frequency of Response: Annually. report distributions from a medical Estimated Number of Respondents: Estimated Total Number of Annual savings account as set forth in section 310. Responses: 2,000. 220(h). Frequency of Response: Annually. Form: 1099–SA. Estimated Time per Response: .25 Estimated Total Number of Annual hours per response. Affected Public: Businesses or other Responses: 310. for-profits. Estimated Total Annual Burden Estimated Time per Response: 29.03 Hours: 500. Estimated Number of Respondents: hours per response. 10,336. Estimated Total Annual Burden Title: Form 8802—Application for Frequency of Response: 2.4999 Hours: 9,000. United States Residency Certification. responses per respondent. OMB Control Number: 1545–1817. Title: REG–209709–94 (Final-TD Estimated Total Number of Annual Type of Review: Extension without 8865) Amortization of Intangible Responses: 25,839. change of a currently approved Property. Estimated Time per Response: .14 collection. OMB Control Number: 1545–1671. hours per response. Description: All requests for U.S. Type of Review: Extension without Estimated Total Annual Burden residency certification must be received change of a currently approved Hours: 3,618. on Form 8802, Application for United Title: HSA, Archer MSA, or Medicare collection. Description: The collection of States Residency Certification. This Advantage MSA Information. information in this previously approved application must be sent to the OMB Control Number: 1545–1518. Philadelphia Service Center. As proof of Type of Review: Extension without regulation is in § 1.197–2(h)(9). This information is required in order to residency in the United States and of change of a currently approved entitlement to the benefits of a tax collection. provide guidance on the time and manner of making the election under treaty, U.S. treaty partner countries Description: Section 220(h) requires require a U.S. Government certification trustees to report to the IRS and medical section 197(f)(9)(B). Under this election, the seller of a section 197 intangible that you are a U.S. citizen, U.S. savings account holders the Corporation, U.S. partnership, or contributions and year-end fair market may pay a tax on the sale in order to avoid the application of the resident of the United States for value of any contributions made to a purposes of taxation. medical savings account (MSA). antichurning rules of section 197(f)(9) to the purchaser. This information will be Form: 8802. Congress requires Treasury to report to Affected Public: Businesses or other them the total contributions made to an used to confirm the parties to the transaction, calculate any additional tax for-profits. MSA for the current tax year. Section Estimated Number of Respondents: 1201 of the Medicare prescription Drug, due, and notify the purchaser of the seller’s election. The likely respondents 1,000,000. Improvement, and Modernization Act of Frequency of Response: On occasion. are business or other for-profit 2003 (Public Law 108–173) created new Estimated Total Number of Annual institutions. Code section 223. Section 223(h) Responses: 130,132. requires the reporting of contributions Form: None. Affected Public: Businesses or other Estimated Time per Response: 3.63 to and the year-end fair market value of hours per response. health savings accounts for tax years for-profits. Estimated Number of Respondents: Estimated Total Annual Burden beginning after December 31, 2003. Hours: 472,380. Form: 5498–SA. 500. Affected Public: Businesses or other Frequency of Response: Annually. Title: TD 9157 (Final) Guidance for-profits. Estimated Total Number of Annual Regarding the Treatment of Certain Estimated Number of Respondents: Responses: 500. Contingent Payment Debt Instruments 9.167. Estimated Time per Response: 3 hours w/one or more Payments that are Frequency of Response: Annually. per response. Denominated in, or Determined by Estimated Total Number of Annual Estimated Total Annual Burden Reference to, a Nonfunctional Currency. Responses: 9,167. Hours: 1,500. OMB Control Number: 1545–1831. Estimated Time per Response: .17 Title: TD 9584—Guidance on Type of Review: Extension without hours per response. Reporting Interest Paid to Nonresident change of a currently approved Estimated Total Annual Burden Aliens. collection. Hours: 1,559. OMB Control Number: 1545–1725. Description: This document contains Title: Low-Income Taxpayer Clinic Type of Review: Extension without previously approved final regulations Grant Application Package and change of a currently approved regarding the treatment of contingent Guidelines; Grant website. collection. payment debt instruments for which

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one or more payments are denominated Title: Qualified Severance of a Trust Estimated Total Number of Annual in, or determined by reference to, a for Generation-Skipping Transfer (GST) Responses: 20,000. currency other than the taxpayer’s Tax Purposes. Estimated Time per Response: 32.78 functional currency. These regulations OMB Control Number: 1545–1902. hours per response. are necessary because current Type of Review: Extension without Estimated Total Annual Burden regulations do not provide guidance change of a currently approved Hours: 917,800. concerning the tax treatment of such collection. Title: Application for Automatic instruments. The regulations affect Description: This previously Extension of Time To File Form 709 issuers and holders of such instruments approved Regulation requires taxpayers and/or Payment of Gift/Generation- including investment banks and others to report a qualified severance by filing Skipping Transfer Tax. who hold these debt instruments for a Form 706–GS(T), or such other form OMB Control Number: 1545–1913. investments. that may be published by the Internal Type of Review: Extension without Form: None. Revenue Service in the future that is change of a currently approved Affected Public: Businesses or other specifically designated to be utilized to collection. for-profits. report qualified severance’s. Where Description: Form 8892 was created to Estimated Number of Respondents: Form 706–GS(T) is used, the filer serve a dual purpose. First, the form 100. should attach a Notice of Qualified enables taxpayers to request an Frequency of Response: On occasion. Severance to the return that clearly extension of time to File 709, when they Estimated Total Number of Annual identifies the trust that is being severed are not filing an individual income tax Responses: 250. and the new trusts created as a result of extension. Second, it serves as a Estimated Time per Response: .4 the severance. The Notice must also payment voucher for taxpayers, who are hours per response. provide the inclusion ratio of the trust filing an individual income tax Estimated Total Annual Burden that was severed and the inclusion extension (by Form 4868) and will have Hours: 100. ratios of the new trusts resulting from a gift tax balance due on Form 709. Title: Application for Registration (For the severance. The information Form: 8892. Certain Excise Tax Activities) and collected will be used by the IRS to Affected Public: Individuals or Questionnaires. identify the trusts being severed and the Households. OMB Control Number: 1545–1835. new trusts created upon severance. The Estimated Number of Respondents: Type of Review: Extension without collection of information is required in 10,000. change of a currently approved order to have a qualified severance. If Frequency of Response: Annually. collection. there was no reporting requirement, the Estimated Total Number of Annual Description: Form 637 is used to IRS would be unable to achieve its Responses: 10,000. apply for excise tax registration for objectives. Estimated Time per Response: .72 activities under sections 4101, 4222, Form: None. hours per response. and 4682. This includes, but is not Affected Public: Individuals or Estimated Total Annual Burden limited to, pipeline operator or vessel Households. Hours: 7,200. operator: Activity Letter, Enterers, Estimated Number of Respondents: Title: Form 8896—Low Sulfur Diesel position holders, refiners, and terminal 350. Fuel Production Credit. operators, Blenders, Producers or Frequency of Response: On occasion. OMB Control Number: 1545–1914. importers of alcohol, agri-biodiesel, and Estimated Total Number of Annual Type of Review: Extension without biodiesel (including renewable diesel), Responses: 650. change of a currently approved Producers of second generation biofuel. Estimated Time per Response: 2.08 collection. The information will be used to make an hours per response. Description: Internal Revenue Code informed decision on whether the Estimated Total Annual Burden section 45H allows small business applicant/registrant qualifies for Hours: 1,352. refiners a 5 cent/gallon credit for the registration. Form 637 Questionnaires Title: Form 8858—Information Return production of low sulfur diesel fuel. will be used to collect information about of U.S. Persons With Respect To Foreign Form 8896 is used to claim the credit. persons who are attempting to register Disregarded Entities; and Transactions Form: 8896. or are registered with the Internal Between Foreign Disregarded Entity of a Affected Public: Businesses or other Revenue Service (IRS) in accordance Foreign Tax Owner and the Filer. for-profits. with Internal Revenue Code (IRC) OMB Control Number: 1545–1910. Estimated Number of Respondents: § 4101, 4222, or Notice 2005–04. The Type of Review: Revision of a 66. information will be used to make an currently approved collection. Frequency of Response: Annually. informed decision on whether the Description: Form 8858 and Schedule Estimated Total Number of Annual applicant/registrant qualifies for M (Form 8858) are used by certain U.S. Responses: 66. registration. persons that own a foreign disregarded Estimated Time per Response: 3.93 Form: 637. entity (FDE) directly or, in certain hours per response. Affected Public: Businesses or other circumstances, indirectly or Estimated Total Annual Burden for-profits. constructively. The form and schedules Hours: 260. Estimated Number of Respondents: are used to satisfy the reporting Title: 26 U.S. Code § 475—Mark to 4,840. requirements of sections 6011, 6012, market accounting method for dealers in Frequency of Response: On occasion. 6031, and 6038, and related regulations. securities. Estimated Total Number of Annual Forms: 8858, Ach M (F. 8858). OMB Control Number: 1545–1945. Responses: 4,840. Affected Public: Businesses or other Type of Review: Extension without Estimated Time per Response: 6.3 for-profits. change of a currently approved hours per response. Estimated Number of Respondents: collection. Estimated Total Annual Burden 28,000. Description: Section 475 was added Hours: 30,499. Frequency of Response: Annually. by section 13223(a) of the Revenue

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Reconciliation Act of 1993, Public Law Frequency of Response: Annually. Description: The previously approved 103–66, 107 Stat.481, and is effective for Estimated Total Number of Annual final regulations set forth the rules for all taxable years ending on or after Responses: 106,200. taxation of distributions from December 31, 1993. The statutory Estimated Time per Response: .31 Designated Roth Accounts which are a requirements under 26 U.S.C. 475 are hours per response. part of a 401(k) plan or 403(b) plan. codified under 26 CFR part 1, sections Estimated Total Annual Burden Form: None. 1.475 et al. Information collection Hours: 32,922. Affected Public: Businesses or other requirements under § 1.475(a)–4 sets Title: Form 3949–A—Information for-profits. forth an elective safe harbor that permits Referral. Estimated Number of Respondents: dealers in securities and dealers in OMB Control Number: 1545–1960. 397,000. commodities to elect to use the values Type of Review: Extension without Frequency of Response: On occasion. of positions reported on certain change of a currently approved Estimated Total Number of Annual financial statements as the fair market collection. Responses: 397,000. values of those positions for purposes of Description: This application is Estimated Time per Response: 2.26 section 475 of the Internal Revenue voluntary and the information requested hours per response. Code (Code). This safe harbor is helps us determine if there has been a Estimated Total Annual Burden intended to reduce the compliance violation of Income Tax Law. We need Hours: 898,000. burden on taxpayers and to improve the the taxpayer identification numbers- Title: Revenue Procedures 2008–60; administrability of the valuation Social Security Number (SSN) or 2012–27: Election Involving the Repeal requirement of section 475. The Employer Identification Number (EIN) of the Bonding Requirement and recordkeeping requirement under in order to fully process your Notification of Increase of Tax under section 1.475(b)–4 are required to application. Failure to provide this § 42(j)(6). determine whether exemption from information may lead to suspension of OMB Control Number: 1545–2120. mark- to-market treatment is properly processing this application. Type of Review: Extension without claimed, and will be used to make that Form: 3949–A. change of a currently approved determination upon audit of taxpayer’s Affected Public: Individuals or collection. books and records. The information Households. Description: This revenue procedure under section 1.475(c)–1(a)(3)(iii), is Estimated Number of Respondents: affects taxpayers who are maintaining a necessary to determine whether a 215,000. surety bond or a Treasury Direct consolidated group has elected to Frequency of Response: On occasion. Account (TDA) to satisfy the low- Estimated Total Number of Annual disregard inter-member transactions in income housing tax credit recapture Responses: 215,000. determining a member’s status as a exception in § 42(j)(6) of the Internal Estimated Time per Response: .25 dealer in securities. Revenue Code, as in effect on or before hours per response. Form: None. July 30, 2008. This revenue procedure Affected Public: Businesses or other Estimated Total Annual Burden Hours: 53,750. provides the procedures for taxpayers to for-profits. follow when making the election under Estimated Number of Respondents: Title: Form 8899—Notice of Income section 3004(i)(2)(B)(ii) of the Housing 15,708. from Donated Intellectual Property. Assistance Tax Act of 2008 (Pub. L. OMB Control Number: 1545–1962. Frequency of Response: Annually. 110–289) to no longer maintain a surety Estimated Total Number of Annual Type of Review: Extension without bond or a TDA to avoid recapture. Responses: 15,708. change of a currently approved Form: None. Estimated Time per Response: 3.32 collection. Affected Public: Individuals or hours per response. Description: Form 8899 is filed by Estimated Total Annual Burden charitable organizations receiving Households. Hours: 52,182. donations of intellectual property if the Estimated Number of Respondents: 7800. Title: Contributions of Motor donor provides a timely notice. The initial deduction is limited to the Frequency of Response: Annually. Vehicles, Boats, and Airplanes. Estimated Total Number of Annual OMB Control Number: 1545–1959. donor’s basis, additional deductions are Responses: 7,800. Type of Review: Revision of a allowed to the extent of income from the Estimated Time per Response: 1 hour currently approved collection. property, reducing excessive per response. Description: Section 884 of the deductions. American Jobs Creation Act of 1004 Form: 8899. Estimated Total Annual Burden (Pub. L. 108–357) added paragraph 12 to Affected Public: Businesses or other Hours: 7,800. section 170(f) for contributions of used for-profits. Title: Form 8928—Return of Certain motor vehicles, boats, and airplanes. Estimated Number of Respondents: Excise Taxes Under Chapter 43 & TD Section 170(f)(12) requires that a donee 1,000. 9457-Employer Comparable organization provide an Frequency of Response: Annually. Contributions to HSAs and Requirement acknowledgement to the donor of this Estimated Total Number of Annual for filing excise taxes under sections type of property and is required to file Responses: 1,000. 4980B, 4980D, 4980E and 4980G. the same information to the Internal Estimated Time per Response: 5.43 OMB Control Number: 1545–2146. Revenue Service. Form 1098–C may be hours per response. Type of Review: Extension without used as the acknowledgement and it, or Estimated Total Annual Burden change of a currently approved an acceptable substitute, must be filed Hours: 5,430. collection. with the IRS. Title: REG–146459–05—TD 9324 Description: Form 8928 is used by Form: 1098–C. (Final) Designated Roth Contributions employers, group health plans, HMOs, Affected Public: Not-for-profit Under Section 402A. and third party administrators to report institutions. OMB Control Number: 1545–1992. and pay excise taxes due for failures Estimated Number of Respondents: Type of Review: Revision of a under sections 4980B, 4980D, 4980E, 106,200. currently approved collection. and 4980G. The information results

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from the requirement from TD 9457 to Description: Form 8952 was created DEPARTMENT OF THE TREASURY file a return for the payment of the by the IRS in conjunction with a new excise taxes under section 4980B, program developed to permit taxpayers Agency Information Collection 4980D, 4980E, and 4980G of the code. to voluntarily reclassify workers as Activities; Submission for OMB Form: 8928. employees for federal employment tax Review; Comment Request; Multiple Affected Public: Businesses or other purposes and obtain similar relief to Fiscal Service Information Collection for-profits. that obtained in the current Requests Estimated Number of Respondents: Classification Settlement Program. To AGENCY: Departmental Offices, U.S. 100. participate in the program, taxpayers Department of the Treasury. Frequency of Response: On occasion. must meet certain eligibility Estimated Total Number of Annual requirements, apply to participate in ACTION: Notice. Responses: 100. VCSP, and enter into closing agreements SUMMARY: The Department of the Estimated Time per Response: 23.48 with the IRS. Treasury will submit the following hours per response. Form: 8952. information collection requests to the Estimated Total Annual Burden Affected Public: Businesses or other Office of Management and Budget Hours: 2,348. for-profits. (OMB) for review and clearance in Title: TD 9544 (REG–112805–10)— accordance with the Paperwork Branded Prescription Drugs. Estimated Number of Respondents: 1,700. Reduction Act of 1995, on or after the OMB Control Number: 1545–2209. date of publication of this notice. The Frequency of Response: Annually. Type of Review: Extension without public is invited to submit comments on change of a currently approved Estimated Total Number of Annual these requests. collection. Responses: 1,700. DATES: Comments should be received on Description: Section 9008 of the Estimated Time per Response: 9.85 or before November 29, 2018 to be Patient Protection and Affordable Care hours per response. assured of consideration. Act (ACA), Public Law 111–148 (124 Estimated Total Annual Burden Stat. 119 (2010)), as amended by section ADDRESSES: Send comments regarding Hours: 16,745. 1404 of the Health Care and Education the burden estimate, or any other aspect Reconciliation Act of 2010 (HCERA), Title: Form 1098–MA—Mortgage of the information collection, including Public Law 111–152 (124 Stat. 1029 Assistance Payments. suggestions for reducing the burden, to (2010)) imposes an annual fee on OMB Control Number: 1545–2221. (1) Office of Information and Regulatory Affairs, Office of Management and manufacturers and importers of branded Type of Review: Extension without prescription drugs that have gross Budget, Attention: Desk Officer for change of a currently approved Treasury, New Executive Office receipts of over $5 million from the collection. sales of these drugs to certain Building, Room 10235, Washington, DC _ government programs (covered entity/ Description: This form is a statement 20503, or email at OIRA Submission@ covered entities). The previously reported to the IRS and to taxpayers. It OMB.EOP.gov and (2) Treasury PRA approved final regulations supersede will be filed and furnished by State Clearance Officer, 1750 Pennsylvania temporary regulations and describe how Housing Finance Agencies (HFAs) and Ave. NW, Suite 8100, Washington, DC the IRS will administer the branded the Department of Housing and Urban 20220, or email at [email protected]. prescription drug fee. Section 51.7T(b) Development (HUD) to report the total FOR FURTHER INFORMATION CONTACT: of the temporary regulations provides amounts of mortgage assistance Copies of the submissions may be that the IRS will send each covered payments and homeowner mortgage obtained from Jennifer Quintana by entity notification of its preliminary fee payments made to mortgage servicers. emailing [email protected], calling calculation by May 15 of the fee year. The requirement for the statement are (202) 622–0489, or viewing the entire If a covered entity chooses to dispute authorized by Notice 2011–14, information collection request at the IRS’ preliminary fee calculation, the supported by Public Law 111–203, sec. www.reginfo.gov. 1496, and Public Law 110–343, Division covered entity must follow the SUPPLEMENTARY INFORMATION: procedures for submitting an error A, sec. 109. report that are established in § 51.8T. Form: 1098–MA. Bureau of the Fiscal Service (FS) Form: None. Affected Public: State, Local, and 1. Title: Annual Letters—Certificate of Affected Public: Businesses or other Tribal Governments. Authority (A) and Admitted Reinsurer for-profits. Estimated Number of Respondents: (B). Estimated Number of Respondents: 52. OMB Control Number: 1530–0014. 45. Frequency of Response: Annually. Type of Review: Extension without Frequency of Response: On occasion. change of a currently approved Estimated Total Number of Annual Estimated Total Number of Annual collection. Responses: 60,000. Responses: 45. Description: Annual letters sent to Estimated Time per Response: 40 Estimated Time per Response: 2.84 insurance companies providing surety hours per response. hours per response. bonds to protect the U.S. or companies Estimated Total Annual Burden Estimated Total Annual Burden providing reinsurance to the U.S. Hours: 1,800. Hours: 170,400. Information needed for renewal of Title: Form 8952—Application for Authority: 44 U.S.C. 3501 et seq. certified companies and their Voluntary Classification Settlement underwriting limitations, and of Program. Dated: October 25, 2018. admitted reinsurers. OMB Control Number: 1545–2215. Spencer W. Clark, Form: Annual Letter A, Annual Letter Type of Review: Extension without Treasury PRA Clearance Officer. B. change of a currently approved [FR Doc. 2018–23644 Filed 10–29–18; 8:45 am] Affected Public: Businesses or other collection. BILLING CODE 4830–01–P for-profits.

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Estimated Number of Respondents: OMB Control Number: 1530–0035. 20503, or email at OIRA_Submission@ 341. Type of Review: Extension without OMB.EOP.gov and (2) Treasury PRA Frequency of Response: Annually. change of a currently approved Clearance Officer, 1750 Pennsylvania Estimated Total Number of Annual collection. Ave. NW, Suite 8100, Washington, DC Responses: 341. Description: One or more fiduciaries 20220, or email at [email protected]. Estimated Time per Response: 18.75 (individual or corporate) must use this FOR FURTHER INFORMATION CONTACT: hours. form to establish entitlement and Copies of the submissions may be Estimated Total Annual Burden request distribution of United States obtained from Jennifer Quintana by Hours: 6,394. Treasury Securities and/or related emailing [email protected], calling 2. Title: Request for Payment of payments to the person lawfully entitled (202) 622–0489, or viewing the entire Federal Benefit by Check and EFT due to termination of a trust, information collection request at Waiver Form. distribution of an estate, attainment of www.reginfo.gov. OMB Control Number: 1530–0019. majority, restoration to competency, or Type of Review: Extension without other reason. SUPPLEMENTARY INFORMATION: change of a currently approved Form: FS Form 1455. Financial Crimes Enforcement Network collection. Affected Public: Individuals and (FinCEN) Description: 31 CFR part 208 requires households. that all Federal non-tax payments be Estimated Number of Respondents: 1. Title: Suspicious Activity Report by made by electronic funds transfer (EFT). 17,700. Securities and Futures Industries. This form is used to collect information Frequency of Response: On occasion. OMB Control Number: 1506–0019. from individuals requesting a waiver Estimated Total Number of Annual Type of Review: Extension without from the EFT requirement because of a Responses: 17,700. change of a currently approved mental impairment and/or who live in Estimated Time per Response: 30 collection. a remote geographic location that does minutes. Description: Treasury requires certain not support the use of EFT. These Estimated Total Annual Burden securities broker-dealers, futures individuals may continue to receive Hours: 8,850. commission merchants and introducing payment by check. However, 31 CFR brokers in commodities to file part 208 requires individuals requesting Authority: 44 U.S.C. 3501 et seq. suspicious activity reports. This renewal one of these waiver conditions to submit Dated: October 25, 2018. pertains to OMB approval of the a written justification. Spencer W. Clark, information collection requirement per Form: FS Form 1201W, FS Form Treasury PRA Clearance Officer. se imposed upon brokers or dealers in 1201W (SP), FS Form 1201W–DFAS. [FR Doc. 2018–23646 Filed 10–29–18; 8:45 am] securities and futures commission Affected Public: Individuals and BILLING CODE 4810–AS–P merchants and introducing brokers in households. commodities. OMB approval of the Estimated Number of Respondents: allocated burden hours associated with 3,250. DEPARTMENT OF THE TREASURY these requirements (31 CFR 1023.320 Frequency of Response: Once. and 1026.320), stemming from the Estimated Total Number of Annual Agency Information Collection submission and record maintenance of Responses: 3,250. Activities; Submission for OMB the BSARs themselves, is reflected in Estimated Time per Response: 20 Review; Comment Request; Multiple the burden for the BSAR as approved minutes. Financial Crimes Enforcement Network under OMB Control No. 1506–0065. Estimated Total Annual Burden Information Collection Requests This splitting in the coverage of the Hours: 1,083. OMB numbers is a result of FinCEN’s 3. Title: Claim for Lost, Stolen or AGENCY: Departmental Offices, U.S. streamlining of SAR reporting into one Destroyed U.S. Savings Bonds and Department of the Treasury. a single, unified format. Although the Supplemental Statement for U.S. ACTION: Notice. means of reporting was consolidated Securities. into a single reporting format covering OMB Control Number: 1530–0021. SUMMARY: The Department of the multiple industry sectors under OMB Type of Review: Extension without Treasury will submit the following Control No. 1506–0065, the reporting change of a currently approved information collection requests to the requirements themselves are still collection. Office of Management and Budget contained in separate rules covered by Description: The information is (OMB) for review and clearance in various OMB control numbers. necessary to apply for relief on account accordance with the Paperwork Consequently, the burden listed in this of the loss, theft, or destruction of Reduction Act of 1995, on or after the renewal under control number 1506– United States Savings Bonds or the non- date of publication of this notice. The 0019 is estimated at one response and receipt of United States Securities. public is invited to submit comments on one hour in order to avoid double- Form: FS Form 1048, FS Form 2243. these requests. Affected Public: Individuals and counting the same burdens that have DATES: Comments should be received on households. already been included in the estimate or before November 29, 2018 to be Estimated Number of Respondents: under control number 1506–0065. assured of consideration. 72,000. Form: FinCEN Form 111. Frequency of Response: On occasion. ADDRESSES: Send comments regarding Affected Public: Businesses or other Estimated Total Number of Annual the burden estimate, or any other aspect for-profits. Responses: 72,000. of the information collection, including Estimated Number of Respondents: 1. Estimated Time per Response: 17 suggestions for reducing the burden, to Frequency of Response: On Occasion. minutes. (1) Office of Information and Regulatory Estimated Total Number of Annual Estimated Total Annual Burden Affairs, Office of Management and Responses: 1. Hours: 20,352. Budget, Attention: Desk Officer for Estimated Time per Response: 1 hour. 4. Title: Request by Fiduciary for Treasury, New Executive Office Estimated Total Annual Burden Reissue of United States Savings Bonds. Building, Room 10235, Washington, DC Hours: 1 hour.

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2. Title: Anti-Money Laundering DEPARTMENT OF THE TREASURY Estimated Number of Respondents: programs for money services business, 23,781. mutual funds, operators of credit card Agency Information Collection Frequency of Response: On occasion. systems, and Providers of Prepaid Activities; Submission for OMB Estimated Total Number of Annual Access. Review; Comment Request; Multiple Responses: 23,781. OMB Control Number: 1506–0020. Departmental Offices Information Estimated Time per Response: 9 Collection Requests hours. Type of Review: Extension without Estimated Total Annual Burden change of a currently approved AGENCY: Departmental Offices, U.S. Hours: 214,029. collection. Department of the Treasury. 2. Title: Treasury International Capital Description: Money services ACTION: Notice. (TIC) Form D: Report of Holdings of, businesses, mutual funds, and operators and Transactions in, Financial of credit card systems, and providers of SUMMARY: The Department of the Derivatives Contracts with Foreign prepaid access are required to develop Treasury will submit the following Residents. and implement written anti-money information collection requests to the OMB Control Number: 1505–0199. laundering program. A copy of the Office of Management and Budget Type of Review: Revision of a program must be maintained for five (OMB) for review and clearance in currently approved collection. years. See 31 CFR 103.125, 103.130, and accordance with the Paperwork Description: Form D is required by 103.135. Reduction Act of 1995, on or after the law and is designed to collect timely Form: None. date of publication of this notice. The information on International portfolio public is invited to submit comments on capital movements, including U.S. Affected Public: Businesses or other these requests. for-profits. residents’ holdings of, and transactions DATES: Comments should be received on in, financial derivatives contracts with Estimated Number of Respondents: or before November 29, 2018 to be foreign residents. The information is 327,106. assured of consideration. used in the computation of the U.S. Frequency of Response: On Occasion. ADDRESSES: Send comments regarding balance of payments accounts and Estimated Total Number of Annual the burden estimate, or any other aspect international investments position, as Responses: 2,910,406. of the information collection, including well as in the formulation of U.S. Estimated Time per Response: 9 suggestions for reducing the burden, to International financial and monetary minutes. (1) Office of Information and Regulatory policies. Estimated Total Annual Burden Affairs, Office of Management and Form: TIC Form D. Hours: 413,216. Budget, Attention: Desk Officer for Affected Public: Businesses or other Treasury, New Executive Office for-profits. 3. Title: Correspondent Accounts for Estimated Number of Respondents: Foreign Shell Banks; Record keeping Building, Room 10235, Washington, DC 20503, or email at OIRA_Submission@ 35. and Termination of Correspondent Frequency of Response: Quarterly. Accounts. OMB.EOP.gov and (2) Treasury PRA Clearance Officer, 1750 Pennsylvania Estimated Total Number of Annual OMB Control Number: 1506–0043. Ave. NW, Suite 8100, Washington, DC Responses: 140. Type of Review: Extension without 20220, or email at [email protected]. Estimated Time per Response: 30 hours. change of a currently approved FOR FURTHER INFORMATION CONTACT: collection. Estimated Total Annual Burden Copies of the submissions may be Hours: 4,200. Description: These rules prohibit obtained from Jennifer Quintana by domestic financial institutions from 3. Title: Determinations Regarding emailing [email protected], calling Certain Nonbank Financial Companies. maintaining correspondent accounts (202) 622–0489, or viewing the entire with foreign shell banks and require OMB Control Number: 1505–0244. information collection request at Type of Review: Extension without such institutions to maintain records of www.reginfo.gov. change of a currently approved the owners, and agents, for service of SUPPLEMENTARY INFORMATION: collection. legal process of foreign banks. Description: The information Form: None. Departmental Offices (DO) collected in § 1310.20 from state Affected Public: Businesses or other 1. Title: Solicitation of Proposal regulatory agencies will be used for-profits. Information for Award of Public generally by FSOC to carry out its duties Estimated Number of Respondents: Contracts. under Title I of the Dodd-Frank Act. The 2,000. OMB Control Number: 1505–0081. collections of information in §§ 1310.21 Frequency of Response: On Occasion. Type of Review: Extension without and 1310.22 provide an opportunity to change of a currently approved request a hearing or submit written Estimated Total Number of Annual collection. materials to the Council concerning Responses: 27,000. Description: Information requested of whether, in the company’s view, Estimated Time per Response: 11.33 offerors is specific to each procurement material financial distress at the hours. solicitation, and is required for Treasury company, or the nature, scope, size, Estimated Total Annual Burden to properly evaluate the capabilities and scale, concentration, Hours: 306,000. experience of potential contractors who interconnectedness, or mix of the Authority: 44 U.S.C. 3501 et seq. desire to provide the supplies or activities of the company, could pose a services to be acquired. Evaluation will threat to the financial stability of the Dated: October 25, 2018. be used to determine which proposal United States. Spencer W. Clark, most benefit the Government. Form: None. Treasury PRA Clearance Officer. Form: None. Affected Public: Businesses or other [FR Doc. 2018–23645 Filed 10–29–18; 8:45 am] Affected Public: Businesses or other for-profits. BILLING CODE 4810–02–P for-profits. Estimated Number of Respondents: 1.

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Frequency of Response: On occasion. SUMMARY: The Department of Veterans of podiatrists is intended to enhance the Estimated Total Number of Annual Affairs (VA) is correcting a Notice that flexibility of the Department to recruit, Responses: 1. published in the Federal Register on develop, and retain the most highly- Estimated Time per Response: 20 September 12, 2018 which provides qualified podiatrists to serve our hours. information that podiatrists be paid Nation’s Veterans and maintain a Estimated Total Annual Burden from the Veterans Health standard of excellence in the VA health Hours: 20. Administration (VHA) physician and care system. dentist pay system. Authority: 44 U.S.C. 3501 et seq. Correction DATES: Annual pay ranges are applicable Dated: October 24, 2018. November 25, 2018. In FR Doc. 20018–19847, appearing Spencer W. Clark, FOR FURTHER INFORMATION CONTACT: on page 46259 in the Federal Register Treasury PRA Clearance Officer. Farine Cohen, Program Analyst, Policy of 83 FR 46258, the following correction [FR Doc. 2018–23610 Filed 10–29–18; 8:45 am] and Programs, VHA Workforce is made: BILLING CODE 4810–25–P Management and Consulting Office 1. On page 46259, in the Pay Table (10A2A), Department of Veterans 1—Clinical Specialty, the minimum Affairs, 810 Vermont Avenue NW, TIER 1 dollar amount should be Washington, DC 20420, (202) 461–7179. corrected to read as $103,395 vs. DEPARTMENT OF VETERANS This is not a toll-free number. $100,967. AFFAIRS SUPPLEMENTARY INFORMATION: On September 12, 2018, at 83 FR 46258, VA Dated: October 24, 2018. Annual Pay Ranges for Physicians, published a Notice that provides Jeffrey M. Martin, Dentists, and Podiatrists of the information and gives notices of annual Assistant Director, Office of Regulation Policy Veterans Health Administration (VHA) pay ranges for VHA podiatrists as & Management, Office of the Secretary, Department of Veterans Affairs. AGENCY: Department of Veterans Affairs. prescribed by the Secretary for Department-wide applicability. The pay [FR Doc. 2018–23670 Filed 10–29–18; 8:45 am] ACTION: Notice; correction. table placement and annual salary rates BILLING CODE 8320–01–P

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Reader Aids Federal Register Vol. 83, No. 210 Tuesday, October 30, 2018

CUSTOMER SERVICE AND INFORMATION CFR PARTS AFFECTED DURING OCTOBER

Federal Register/Code of Federal Regulations At the end of each month the Office of the Federal Register General Information, indexes and other finding 202–741–6000 publishes separately a List of CFR Sections Affected (LSA), which aids lists parts and sections affected by documents published since Laws 741–6000 the revision date of each title. Presidential Documents 3 CFR 7 CFR Executive orders and proclamations 741–6000 Proclamations: 51...... 50475 The United States Government Manual 741–6000 9791...... 50241 318...... 49987 Other Services 9792...... 50243 319...... 49987 Electronic and on-line services (voice) 741–6020 9793...... 50245 400...... 51301 Privacy Act Compilation 741–6050 9794...... 50247 900...... 52943 9795...... 50249 906...... 52944 945...... 49776 ELECTRONIC RESEARCH 9796...... 50251 9797...... 50253 982...... 52946 989...... 53965 World Wide Web 9798...... 50803 9799...... 51299 1220...... 53365 Full text of the daily Federal Register, CFR and other publications 9800...... 51613 1400...... 49459 is located at: www.govinfo.gov. 9801...... 51615 1416...... 49459 Federal Register information and research tools, including Public 9802...... 51621 Proposed Rules: Inspection List and electronic text are located at: 9803...... 52111 56...... 50527 www.federalregister.gov. 9804...... 52113 62...... 50527 70...... 50527 E-mail 9805...... 52933 9806...... 52935 226...... 50038 FEDREGTOC (Daily Federal Register Table of Contents Electronic 9807...... 52937 810...... 49498 Mailing List) is an open e-mail service that provides subscribers 9808...... 53797 905...... 49499, 53003 with a digital form of the Federal Register Table of Contents. The 9809...... 53799 920...... 49312 digital form of the Federal Register Table of Contents includes 9810...... 54511 944...... 53003 HTML and PDF links to the full text of each document. Administrative Orders: 985...... 50527 To join or leave, go to https://public.govdelivery.com/accounts/ Memorandums: 986...... 50531 USGPOOFR/subscriber/new, enter your email address, then Memorandum of June 989...... 53402 follow the instructions to join, leave, or manage your 28, 2010 (revoked 1212...... 49314 subscription. by Memo. of October 8 CFR PENS (Public Law Electronic Notification Service) is an e-mail 25, 2018)...... 54513 service that notifies subscribers of recently enacted laws. Memorandum of June Proposed Rules: To subscribe, go to http://listserv.gsa.gov/archives/publaws-l.html 14, 2013 (revoked 103...... 51114 and select Join or leave the list (or change settings); then follow by Memo. of October 212...... 51114 the instructions. 25, 2018)...... 54513 213...... 51114 FEDREGTOC and PENS are mailing lists only. We cannot Memorandum of 214...... 51114 respond to specific inquiries. September 10, 245...... 51114 Reference questions. Send questions and comments about the 2018 ...... 50237 248...... 51114 Memorandum of Federal Register system to: [email protected] 10 CFR The Federal Register staff cannot interpret specific documents or October 16, 2018 ...... 53157 regulations. Memorandum of 52...... 51304 October 19, 2018 ...... 53961 72...... 53159 Proposed Rules FEDERAL REGISTER PAGES AND DATE, OCTOBER Memorandum of October 25, 2018 ...... 54513 2...... 50533 49265–49458...... 1 Notice of October 17, 72...... 53191 49459–49768...... 2 2018 ...... 52941 431...... 49501 49769–49986...... 3 Notice of October 25, 1004...... 54268 49987–50254...... 4 2018 ...... 54227 50255–50474...... 5 Presidential 11 CFR 50475–50802...... 9 Determinations: 9405...... 53801 50803–51300...... 10 No. 2018–12 of 9407...... 53801 51301–51620...... 11 September 11, 9409...... 53801 51621–51814...... 12 2018 ...... 50239 9410...... 53801 51815–52114...... 15 No. 2018–13 of 9420...... 53801 52115–52304...... 16 September 28, 9428...... 53801 52305–52750...... 17 2018 ...... 53363 52751–52942...... 18 No. 2019–02 of 12 CFR 52943–53158...... 19 October 5, 2018 ...... 51617 45...... 50805 53159–53362...... 22 No. 2019–03 of 201...... 49472 53363–53562...... 23 October 5, 2018 ...... 51619 204...... 49473, 54517 53563–53800...... 24 237...... 50805 5 CFR 53801–53964...... 25 349...... 50805 53965–54228...... 26 9800...... 49769 624...... 50805 54229–54512...... 29 Proposed Rules: 1221...... 50805 54313–54662...... 30 337...... 54266 1231...... 49987

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1239...... 52950 420...... 52767 800...... 51316 3050...... 52178 1273...... 52950 Proposed Rules: 801...... 51322 40 CFR 1290...... 52115 4...... 52902 Proposed Rules: Proposed Rules: 210...... 49630 1...... 54059 9 ...... 49295, 49806, 50838, 30...... 50046 229...... 49630 51360, 54031, 54032 350...... 53829 239...... 49630 32 CFR 52 ...... 49295, 49297, 49298, 722...... 49857 240 ...... 49630, 50297, 53007 310...... 52317 49300, 49492, 49826, 50007, 1083...... 51653 249...... 49630 706...... 52768 50010, 50012, 50014, 50018, Proposed Rules: 50022, 50024, 50264, 50266, 14 CFR 18 CFR 151...... 53020 50271, 50274, 50506, 50849, 25 ...... 53163, 53166, 53168 4...... 53575 275...... 54297 50851, 50854, 51361, 51366, 29...... 51623, 51624 40...... 53992 553...... 53412 51629, 52772, 52983, 53816, 39 ...... 49265, 49269, 49272, Proposed Rules: 54032, 54053 49275, 49475, 49780, 49784, 2...... 51654 33 CFR 61...... 53183, 49786, 49789, 49791, 49793, 38...... 51654 100 ...... 49489, 51625, 52770 63...... 51842, 53183 50477, 50479, 50482, 50814, 117 ...... 49278, 49279, 49280, 70...... 49300 50816, 50818, 50821, 51304, 20 CFR 50007, 50259, 51628, 51837, 71...... 54521 51313, 51815, 51819, 51823, 416...... 51836 51838, 52148, 52319, 52976, 72...... 54521 51825, 51829, 52118, 52120, 53375, 53376, 53584, 53810, 80...... 53584 Proposed Rules: 81...... 50024, 52157 52123, 52126, 52131, 52135, 404...... 51400 53813, 54245, 54247, 54248 52137, 52140, 52143, 52305, 165 ...... 49281, 49283, 50260, 82...... 50026 408...... 51400 131...... 52163 52751, 52754, 52756, 53171, 416...... 51400 50262, 50503, 51334, 51336, 53366, 53368, 53563, 53567, 51338, 51628, 51838, 52320, 141...... 51636 53569, 53573, 53802, 53974, 21 CFR 52977, 52979, 52981, 53814 180 ...... 50284, 51857, 51863, 53976, 54229 52986, 52991, 52996, 54259 172...... 50487, 50490 Proposed Rules: 271...... 54521 71 ...... 49277, 49482, 49483, 100...... 52333 177...... 50490 272...... 54521 50255, 50256, 50823, 51315, 165 ...... 50310, 50545, 53023, 573...... 49485 700...... 52694 51832, 51833, 51834, 52147, 53199 866...... 52313 720...... 52694 53806, 53807, 53809, 53979, 868...... 52964, 54006 53981, 53982, 53983, 54232, 34 CFR 721 ...... 49295, 49806, 50838, 874...... 54007 51360, 54031, 54032 54234, 54236, 54238, 54239, 611...... 52148 878 ...... 52966, 52968, 52970 723...... 52694 54519 614...... 52148 882...... 52315, 52972 725...... 52694 91...... 52954, 53985 636...... 52148 886...... 52973 790...... 52694 97 ...... 53174, 53177, 54241, 649...... 52148 Proposed Rules: 791...... 52694 54243 112...... 53196 680...... 52148 Chap. II ...... 53991 693...... 52148 Proposed Rules: 117...... 53197 9...... 51910, 51911 Proposed Rules: 573...... 49508, 54526 695...... 52148 21...... 50536 696...... 52148 52 ...... 49330, 49509, 49870, 23...... 54057 22 CFR 697...... 52148 49872, 49894, 50052, 50312, 25...... 53193 698...... 52148 50314, 50548, 50551, 50865, 5...... 50823 50867, 51403, 53201, 53832, 39 ...... 49317, 50047, 50537, 121...... 50003 699...... 52148 50539, 50860, 50862, 51887, 54300 123...... 50003 Proposed Rules: 60 ...... 52056, 54303, 54527, 51889, 52171, 52173, 53404, Ch. VI...... 51906 53407, 53409 23 CFR 54532 61...... 53195 36 CFR 61...... 54532 658 Appendix C...... 49487 62...... 49897 71 ...... 49506, 50050, 51895, 242...... 50758 771...... 54480 63...... 54532 51897, 51898, 51900, 51901, 1007...... 50826 774...... 54480 70...... 49509, 54532 51903 1008...... 50826 72...... 54532 91...... 53590, 54278 24 CFR 1009...... 50826 81...... 50556 570...... 50257 1011...... 50826 15 CFR 82...... 49332 Proposed Rules: 85...... 53204 902...... 49994, 52760 26 CFR 242...... 49322 86...... 49344, 53204 Proposed Rules: 1 ...... 50258, 50864, 51072 37 CFR 180...... 52787, 53594 740...... 53411, 53742 Proposed Rules: 192...... 54543 742...... 53742 1 ...... 51904, 52726, 54279, 42...... 51340 271 ...... 49900, 50869, 53595, 744...... 53742, 54519 54420, 54527 201 ...... 51840, 52150, 54010 54304 758...... 53411 54...... 54420 Proposed Rules: 272...... 53595 772...... 53742 301...... 51906, 52726 201...... 52176, 52336 721 ...... 49903, 50872, 51910, 774...... 53742 602...... 51904 202...... 52336 51911, 52179 16 CFR 29 CFR 38 CFR 42 CFR 410...... 50484 4001...... 49799 3...... 52322, 53179 411...... 49832 1234...... 53371 4022...... 49799, 51836 4...... 54250 412...... 49832 Proposed Rules: 4043...... 49799 36...... 50506 413...... 49832, 49836 1130...... 50542 4044...... 49799 Proposed Rules: 424...... 49832, 49836 Proposed Rules: 17...... 52345 495...... 49836 17 CFR 541...... 49869 Proposed Rules: 39 CFR 210...... 50148 2510...... 53534, 54420 84...... 53835 227...... 52962 2590...... 54420 20...... 52323 Ch. IV...... 54546 229...... 50148 111...... 51359, 52326 403...... 52789 230...... 50148, 52962 30 CFR 3010...... 52154 405...... 49513 239...... 50148 779...... 53575 3050...... 49286 423...... 49513 240...... 50148 Proposed Rules: 249...... 50148 31 CFR 20...... 52351 44 CFR 274...... 50148 33...... 53575 111...... 52353 Ch. I ...... 49302

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64...... 50289 404...... 52355 15...... 53421 50 CFR 16...... 53421 45 CFR 47 CFR 17...... 52775 232...... 50052 102...... 51369 1...... 51867, 53822 100...... 50758 242...... 50052 300...... 52760 155...... 53575 27...... 53190 252...... 50052 Proposed Rules: 52...... 53377 622 ...... 50295, 51390, 52330, 144...... 54480 64...... 53588 53823 146...... 54480 73...... 50035 49 CFR 635 ...... 50857, 51391, 52169 147...... 54480 Proposed Rules: 264...... 54480 648 ...... 53399, 53824, 53825, 155...... 54480 9...... 54180 541...... 53396 54055, 54264 12...... 54180 655...... 53399 46 CFR 622...... 54480 20...... 54180 Proposed Rules: 660...... 50510, 53827 136...... 53818 25...... 54180 10...... 50053 665...... 49495 142...... 53818 54...... 53420 172...... 52878 679 ...... 49496, 49497, 49994, 502...... 50290 63...... 53026 175...... 52878 50036, 51399, 52332, 52760 503...... 50290 64...... 54180 Proposed Rules: 515...... 50290 76...... 51911 395...... 50055 520...... 50290 523...... 53204 17 ...... 50560, 50574, 50582, 530...... 50290 48 CFR 531...... 53204 50610, 51418, 51570, 54561 535...... 50290 801...... 49302 533...... 53204 100...... 49322 540...... 50290 811...... 49302 536...... 53204 229...... 53422 550...... 50290 832...... 49302 537...... 53204 622 ...... 50056, 51424, 53839, 555...... 50290 852...... 49302 555...... 50872 54069 560...... 50290 870...... 49302, 54054 571...... 50872, 51766 648...... 50059, 53440 Proposed Rules: Proposed Rules: 591...... 50872 697...... 50061 401...... 52355 13...... 53421 1152...... 50326 698...... 51426

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in today’s List of Public enacted public laws. To Laws. subscribe, go to http:// LIST OF PUBLIC LAWS Public Laws Electronic listserv.gsa.gov/archives/ Last List October 29, 2018 Notification Service publaws-l.html (PENS) Note: No public bills which Note: This service is strictly have become law were for E-mail notification of new received by the Office of the PENS is a free electronic mail laws. The text of laws is not Federal Register for inclusion notification service of newly available through this service. PENS cannot respond to specific inquiries sent to this address.

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