| Page Range | 54513-54661 | |
| FR Document |
| Page and Subject | |
|---|---|
| 83 FR 54513 - Developing a Sustainable Spectrum Strategy for America's Future | |
| 83 FR 54591 - Performance Review Board Membership | |
| 83 FR 54630 - Sunshine Act Meetings | |
| 83 FR 54621 - Sunshine Act Meetings | |
| 83 FR 54598 - Denial of Hearing Request Regarding Proposal To Refuse To Approve a New Drug Application for Oxycodone Hydrochloride Immediate-Release Abuse-Deterrent Formulation, Oral Capsules, 5 Milligrams, 15 Milligrams, and 30 Milligrams; Order Refusing Approval | |
| 83 FR 54608 - Notice of Public Meeting | |
| 83 FR 54614 - Eric Lee Knight, M.D.; Decision and Order | |
| 83 FR 54643 - Agency Information Collection Activities; Revision of an Approved Information Collection Request: Commercial Driver Licensing and Test Standards | |
| 83 FR 54644 - Qualification of Drivers; Exemption Applications; Vision | |
| 83 FR 54612 - Importer of Controlled Substances Application: Sharp (Bethlehem), LLC | |
| 83 FR 54612 - Importer of Controlled Substances Application: Fisher Clinical Services, Inc. | |
| 83 FR 54611 - Importer of Controlled Substances Application: United States Pharmacopeial Convention | |
| 83 FR 54527 - Adopting Subpart Ba Requirements in Emission Guidelines for Municipal Solid Waste Landfills | |
| 83 FR 54610 - Importer of Controlled Substances Application: Cambrex High Point, Inc. | |
| 83 FR 54611 - Bulk Manufacturer of Controlled Substances Registration | |
| 83 FR 54561 - Endangered and Threatened Wildlife and Plants; Removing the Hawaiian Hawk From the Federal List of Endangered and Threatened Wildlife | |
| 83 FR 54611 - Bulk Manufacturer of Controlled Substances Application: Insys Manufacturing, LLC | |
| 83 FR 54613 - Bulk Manufacturer of Controlled Substances Application: Sigma Aldrich Research | |
| 83 FR 54620 - Instructions for Completing NRC's Uniform Low-Level Radioactive Waste Manifest | |
| 83 FR 54519 - Addition of an Entity to the Entity List | |
| 83 FR 54546 - Medicare Program; International Pricing Index Model for Medicare Part B Drugs | |
| 83 FR 54613 - Importer of Controlled Substances Application: Catalent CTS, LLC | |
| 83 FR 54604 - Meeting of the National Advisory Council on Nurse Education and Practice | |
| 83 FR 54610 - Importer of Controlled Substances Registration | |
| 83 FR 54591 - Formations of, Acquisitions by, and Mergers of Savings and Loan Holding Companies | |
| 83 FR 54590 - Formations of, Acquisitions by, and Mergers of Bank Holding Companies | |
| 83 FR 54575 - Proposed Collection; Comment Request | |
| 83 FR 54617 - Proposed Extension of Existing Collection; Comment Request | |
| 83 FR 54526 - Zinpro Corp.; Filing of Food Additive Petition (Animal Use) | |
| 83 FR 54526 - Adisseo France S.A.S.; Filing of Food Additive Petition (Animal Use) | |
| 83 FR 54661 - Annual Pay Ranges for Physicians, Dentists, and Podiatrists of the Veterans Health Administration (VHA) | |
| 83 FR 54581 - Energy Conservation Program: Decision and Order Granting a Waiver to AHT Cooling Systems GmbH and AHT Cooling Systems USA Inc. From the Department of Energy Commercial Refrigerator, Freezer, and Refrigerator-Freezer Test Procedure | |
| 83 FR 54580 - Agency Information Collection Extension | |
| 83 FR 54566 - Crystalline Silicon Photovoltaic Cells, Whether or Not Assembled Into Modules, From the People's Republic of China: Amended Final Results of Countervailing Duty Administrative Review; 2015 | |
| 83 FR 54579 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Student Assistance General Provisions-Subpart K-Cash Management | |
| 83 FR 54579 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Income Based Repayment-Notifications | |
| 83 FR 54578 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Health Education Assistance Loan (HEAL) Program: Forms | |
| 83 FR 54580 - Agency Information Collection Activities; Comment Request; FY 2018 Child Care Access Means Parents in School Annual Performance Report Package 84.335A | |
| 83 FR 54566 - Approval of Subzone Status; Digi-Key Corporation; Thief River Falls, Minnesota | |
| 83 FR 54568 - Certain Steel Wheels From the People's Republic of China: Preliminary Determination of Sales at Less-Than-Fair-Value | |
| 83 FR 54618 - Arts Advisory Panel Meetings | |
| 83 FR 54652 - Notice of OFAC Sanctions Actions | |
| 83 FR 54649 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel ONE LOVE; Invitation for Public Comments | |
| 83 FR 54648 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel Y KNOT; Invitation for Public Comments | |
| 83 FR 54650 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel MACONDO; Invitation for Public Comments | |
| 83 FR 54571 - Marine Mammals; Issuance of Permits | |
| 83 FR 54570 - Marine Mammals; File No. 22095 | |
| 83 FR 54651 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel SHANGHAI MAC; Invitation for Public Comments | |
| 83 FR 54647 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel YEMAYA; Invitation for Public Comments | |
| 83 FR 54615 - Affirmative Decisions on Petitions for Modification Granted in Whole or in Part | |
| 83 FR 54588 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NESHAP for Chemical Recovery Combustion Sources at Kraft, Soda, Sulfite, and Stand-Alone Semichemical Pulp Mill (Renewal) | |
| 83 FR 54616 - Preparations for the 36th Session of the UN Sub-Committee of Experts on the Globally Harmonized System of Classification and Labelling of Chemicals (UNSCEGHS) | |
| 83 FR 54658 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Multiple Fiscal Service Information Collection Requests | |
| 83 FR 54659 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Multiple Financial Crimes Enforcement Network Information Collection Requests | |
| 83 FR 54653 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Multiple IRS Information Collection Requests | |
| 83 FR 54584 - Environmental Management Site-Specific Advisory Board, Paducah | |
| 83 FR 54583 - Environmental Management Site-Specific Advisory Board, Oak Ridge | |
| 83 FR 54593 - 21st Century Cures: Announcing the Establishment of a Surrogate Endpoint Table; Establishment of a Public Docket; Request for Comments | |
| 83 FR 54573 - Submission for OMB Review; Comment Request | |
| 83 FR 54606 - Information Collection Request to Office of Management and Budget; OMB Control Number: 1625-0088 | |
| 83 FR 54607 - Collection of Information Under Review by Office of Management and Budget; OMB Control Number: 1625-0015 | |
| 83 FR 54597 - Considerations for the Development of Dried Plasma Products Intended for Transfusion; Draft Guidance for Industry; Availability | |
| 83 FR 54527 - Additional First Year Depreciation Deduction; Hearing | |
| 83 FR 54594 - Sesame as an Allergen in Foods | |
| 83 FR 54573 - Nominations for the 2019-2022 General Advisory Committee and the Scientific Advisory Subcommittee to the United States Delegation to the Inter-American Tropical Tuna Commission | |
| 83 FR 54521 - North Dakota: Authorization of State Hazardous Waste Management Program Revisions and Incorporation by Reference of Approved State Hazardous Waste Management Program | |
| 83 FR 54587 - North Dakota Pollutant Discharge Elimination System; Transfer | |
| 83 FR 54532 - Proposed Approval of Recodification and Revisions to State Air Pollution Control Rules; North Dakota; Proposed Interim Approval of Title V Program Recodification and Revisions; Proposed Approval of Recodification and Revisions To State Programs and Delegation of Authority To Implement and Enforce Clean Air Act Section 111 and 112 Standards and Requirements | |
| 83 FR 54624 - Federal Salary Council; Meeting Notice | |
| 83 FR 54622 - Southern Nuclear Operating Company, Inc., Vogtle Electric Generating Plant, Units 3 and 4; Changes to Tier 2* Departure Evaluation Process | |
| 83 FR 54643 - Presidential Declaration of a Major Disaster for Public Assistance Only for the State of Florida | |
| 83 FR 54624 - Self-Regulatory Organizations; Cboe EDGX Exchange, Inc.; Notice of Filing of a Proposed Rule Change To Permit the Listing and Trading of P.M.-Settled Series on Certain Broad-Based Index Options on a Pilot Basis | |
| 83 FR 54635 - Self-Regulatory Organizations; Cboe BZX Exchange, Inc.; Notice of Filing of a Proposed Rule Change To Permit the Listing and Trading of P.M.-Settled Series on Certain Broad-Based Index Options on a Pilot Basis | |
| 83 FR 54634 - Self-Regulatory Organizations; Nasdaq MRX, LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Delete Current Rules on Arbitration, Under Chapter 18 | |
| 83 FR 54632 - Self-Regulatory Organizations; Nasdaq ISE, LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Delete Current Rules on Arbitration, under Chapter 18 | |
| 83 FR 54641 - Self-Regulatory Organizations; Nasdaq PHLX LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Delete Current Rules on Arbitration | |
| 83 FR 54630 - Self-Regulatory Organizations; Nasdaq BX, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Delete the Current Rules on Arbitration | |
| 83 FR 54623 - Revised 658th Meeting of the Advisory Committee on Reactor Safeguards (ACRS) | |
| 83 FR 54608 - Certain X-Ray Breast Imaging Devices and Components Thereof; Notice of a Commission Determination To Review the Final Initial Determination In-Part; Extension of the Target Date | |
| 83 FR 54604 - Government-Owned Inventions; Availability for Licensing | |
| 83 FR 54605 - Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meetings | |
| 83 FR 54605 - National Institute on Aging; Notice of Closed Meeting | |
| 83 FR 54605 - National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed Meetings | |
| 83 FR 54575 - Arms Sales Notification | |
| 83 FR 54591 - Medicare and Medicaid Programs: Application From the American Association for Accreditation of Ambulatory Surgery Facilities, Inc. (AAAASF) for Continued CMS-Approval of Its Outpatient Physical Therapy and Speech Language Pathology Services Accreditation Program | |
| 83 FR 54660 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Multiple Departmental Offices Information Collection Requests | |
| 83 FR 54517 - Reserve Requirements of Depository Institutions | |
| 83 FR 54572 - Public Meeting for Recommending a National Estuarine Research Reserve Site in Connecticut's Lower Connecticut River and Eastern Long Island Sound | |
| 83 FR 54566 - Notice of Public Meetings of the New York Advisory Committee | |
| 83 FR 54584 - New England Power Generators, Inc. v. ISO New England Inc.; Notice of Filing | |
| 83 FR 54586 - Venture Global Calcasieu Pass, LLC; TransCameron Pipeline, LLC; Notice of Availability of the Final Environmental Impact Statement for the Proposed Calcasieu Pass Project | |
| 83 FR 54585 - Panel Member List for Hydropower Licensing Study Dispute Resolution; Notice Requesting Applications for Panel Members for Hydropower Licensing Study Dispute Resolution | |
| 83 FR 54585 - National Fuel Gas Supply Corporation; Notice of Request Under Blanket Authorization | |
| 83 FR 54589 - Agency Information Collection Activities: Submission for OMB Review; Comment Request | |
| 83 FR 54619 - Meeting of National Council on the Humanities | |
| 83 FR 54645 - Proposed Agency Information Collection Activities; Comment Request | |
| 83 FR 54543 - Health and Environmental Protection Standards for Uranium and Thorium Mill Tailings | |
| 83 FR 54519 - Amendment of Air Traffic Service (ATS) Routes in the Vicinity of Mattoon and Charleston, IL |
Foreign-Trade Zones Board
Industry and Security Bureau
International Trade Administration
National Oceanic and Atmospheric Administration
Army Department
Federal Energy Regulatory Commission
Centers for Medicare & Medicaid Services
Food and Drug Administration
Health Resources and Services Administration
National Institutes of Health
Coast Guard
Bureau of Safety and Environmental Enforcement
Fish and Wildlife Service
Drug Enforcement Administration
Mine Safety and Health Administration
Occupational Safety and Health Administration
Workers Compensation Programs Office
National Endowment for the Arts
National Endowment for the Humanities
Federal Aviation Administration
Federal Motor Carrier Safety Administration
Federal Railroad Administration
Maritime Administration
Foreign Assets Control Office
Internal Revenue Service
Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice of recently enacted public laws.
To subscribe to the Federal Register Table of Contents electronic mailing list, go to https://public.govdelivery.com/accounts/USGPOOFR/subscriber/new, enter your e-mail address, then follow the instructions to join, leave, or manage your subscription.
Board of Governors of the Federal Reserve System.
Final rule.
The Board is amending Regulation D, Reserve Requirements of Depository Institutions, to reflect the annual indexing of the reserve requirement exemption amount and the low reserve tranche for 2019. The Regulation D amendments set the amount of total reservable liabilities of each depository institution that is subject to a zero percent reserve requirement in 2019 at $16.3 million (up from 16.0 million in 2018). This amount is known as the reserve requirement exemption amount. The Regulation D amendments also set the amount of net transaction accounts at each depository institution (over the reserve requirement exemption amount) that is subject to a three percent reserve requirement in 2019 at $124.2 million (up from $122.3 million in 2018). This amount is known as the low reserve tranche. The adjustments to both of these amounts are derived using statutory formulas specified in the Federal Reserve Act.
The Board is also announcing changes in two other amounts, the nonexempt deposit cutoff level and the reduced reporting limit, that are used to determine the frequency at which depository institutions must submit deposit reports.
Sophia H. Allison, Senior Special Counsel (202/452-3565), Legal Division, or Kristen R. Payne, Senior Financial Institution and Policy Analyst (202/452-2872), Division of Monetary Affairs; for users of Telecommunications Device for the Deaf (TDD) only, contact (202/263-4869); Board of Governors of the Federal Reserve System, 20th and C Streets NW, Washington, DC 20551.
Section 19(b)(2) of the Federal Reserve Act (12 U.S.C. 461(b)(2)) requires each depository institution to maintain reserves against its transaction accounts and nonpersonal time deposits, as prescribed by Board regulations, for the purpose of implementing monetary policy. Section 11(a)(2) of the Federal Reserve Act (12 U.S.C. 248(a)(2)) authorizes the Board to require reports of liabilities and assets from depository institutions to enable the Board to conduct monetary policy. The Board's actions with respect to each of these provisions are discussed in turn below.
Pursuant to section 19(b) of the Federal Reserve Act (Act), transaction account balances maintained at each depository institution are subject to reserve requirement ratios of zero, three, or ten percent. Section 19(b)(11)(A) of the Act (12 U.S.C. 461(b)(11)(A)) provides that a zero percent reserve requirement shall apply at each depository institution to total reservable liabilities that do not exceed a certain amount, known as the reserve requirement exemption amount. Section 19(b)(11)(B) provides that, before December 31 of each year, the Board shall issue a regulation adjusting the reserve requirement exemption amount for the next calendar year if total reservable liabilities held at all depository institutions increase from one year to the next. No adjustment is made to the reserve requirement exemption amount if total reservable liabilities held at all depository institutions should decrease during the applicable time period. The Act requires the percentage increase in the reserve requirement exemption amount to be 80 percent of the increase in total reservable liabilities of all depository institutions over the one-year period that ends on the June 30 prior to the adjustment.
Total reservable liabilities of all depository institutions increased by 2.4 percent, from $7,858 billion to $8,050 billion, between June 30, 2017, and June 30, 2018. Accordingly, the Board is amending Regulation D to set the reserve requirement exemption amount for 2019 at $16.3 million, an increase of $0.3 million from its level in 2018.
Pursuant to section 19(b)(2) of the Act (12 U.S.C. 461(b)(2)), transaction account balances maintained at each depository institution over the reserve requirement exemption amount and up to a certain amount, known as the low reserve tranche, are subject to a three percent reserve requirement. Transaction account balances over the low reserve tranche are subject to a ten percent reserve requirement. Section 19(b)(2) also provides that, before December 31 of each year, the Board shall issue a regulation adjusting the low reserve tranche for the next calendar year. The Act requires the adjustment in the low reserve tranche to be 80 percent of the percentage increase or decrease in total transaction accounts of all depository institutions over the one-year period that ends on the June 30 prior to the adjustment.
Net transaction accounts of all depository institutions increased 2.0 percent, from $2,379 billion to $2,425 billion, between June 30, 2017, and June 30, 2018. Accordingly, the Board is amending Regulation D to set the low reserve tranche for net transaction
The new low reserve tranche and reserve requirement exemption amount will be effective for all depository institutions for the fourteen-day reserve maintenance period beginning Thursday, January 17, 2019. For depository institutions that report deposit data weekly, this maintenance period corresponds to the fourteen-day computation period that begins December 18, 2018. For depository institutions that report deposit data quarterly, this maintenance period corresponds to the seven-day computation period that begins December 18, 2018.
Section 11(b)(2) of the Federal Reserve Act authorizes the Board to require depository institutions to file reports of their liabilities and assets as the Board may determine to be necessary or desirable to enable it to discharge its responsibility to monitor and control the monetary and credit aggregates. The Board screens depository institutions each year and assigns them to one of four deposit reporting panels (weekly reporters, quarterly reporters, annual reporters, or nonreporters). The panel assignment for annual reporters is effective in June of the screening year; the panel assignment for weekly and quarterly reporters is effective in September of the screening year.
In order to ease reporting burden, the Board permits smaller depository institutions to submit deposit reports less frequently than larger depository institutions. The Board permits depository institutions with net transaction accounts above the reserve requirement exemption amount but total transaction accounts, savings deposits, and small time deposits below a specified level (the “nonexempt deposit cutoff”) to report deposit data quarterly. Depository institutions with net transaction accounts above the reserve requirement exemption amount and with total transaction accounts, savings deposits, and small time deposits greater than or equal to the nonexempt deposit cutoff are required to report deposit data weekly. The Board requires certain large depository institutions to report weekly regardless of the level of their net transaction accounts if the depository institution's total transaction accounts, savings deposits, and small time deposits exceeds or is equal to a specified level (the “reduced reporting limit”). The nonexempt deposit cutoff level and the reduced reporting limit are adjusted annually, by an amount equal to 80 percent of the increase, if any, in total transaction accounts, savings deposits, and small time deposits of all depository institutions over the one-year period that ends on the June 30 prior to the adjustment.
From June 30, 2017, to June 30, 2018, total transaction accounts, savings deposits, and small time deposits at all depository institutions increased 3.6 percent, from $12,157 billion to $12,599 billion. Accordingly, the Board is increasing the nonexempt deposit cutoff level by $29.1 million to $1.029 billion for 2019 (up from $1.000 billion in 2018). The Board is also increasing the reduced reporting limit by $60.7 million to $2.147 billion for 2019 (up from $2.086 billion in 2018).
Beginning in 2019, the boundaries of the four deposit reporting panels will be defined as follows. Those depository institutions with net transaction accounts over $16.3 million (the reserve requirement exemption amount) or with total transaction accounts, savings deposits, and small time deposits greater than or equal to $2.147 billion (the reduced reporting limit) are subject to detailed reporting, and must file a Report of Transaction Accounts, Other Deposits and Vault Cash (FR 2900 report) either weekly or quarterly. Of this group, those with total transaction accounts, savings deposits, and small time deposits greater than or equal to $1.029 billion (the nonexempt deposit cutoff level) are required to file the FR 2900 report each week, while those with total transaction accounts, savings deposits, and small time deposits less than $1.029 billion are required to file the FR 2900 report each quarter. Those depository institutions with net transaction accounts less than or equal to $16.3 million (the reserve requirement exemption amount) and with total transaction accounts, savings deposits, and small time deposits less than $2.147 billion (the reduced reporting limit) are eligible for reduced reporting, and must either file a deposit report annually or not at all. Of this group, those with total deposits greater than $16.3 million (but with total transaction accounts, savings deposits, and small time deposits less than $2.147 billion) are required to file the Annual Report of Deposits and Reservable Liabilities (FR 2910a) report annually, while those with total deposits less than or equal to $16.3 million are not required to file a deposit report. A depository institution that adjusts reported values on its FR 2910a report in order to qualify for reduced reporting will be shifted to an FR 2900 reporting panel.
The provisions of 5 U.S.C. 553(b) relating to notice of proposed rulemaking have not been followed in connection with the adoption of these amendments. The amendments involve expected, ministerial adjustments prescribed by statute and by the Board's policy concerning reporting practices. The adjustments in the reserve requirement exemption amount, the low reserve tranche, the nonexempt deposit cutoff level, and the reduced reporting limit serve to reduce regulatory burdens on depository institutions. Accordingly, the Board finds good cause for determining, and so determines, that notice in accordance with 5 U.S.C. 553(b) is unnecessary.
The Regulatory Flexibility Act (RFA) does not apply to a rulemaking where a general notice of proposed rulemaking is not required.
In accordance with the Paperwork Reduction Act of 1995,
Banks, banking, Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, the Board is amending 12 CFR part 204 as follows:
12 U.S.C. 248(a), 248(c), 461, 601, 611, and 3105.
(f) For all depository institutions, Edge and Agreement corporations, and United States branches and agencies of foreign banks, required reserves are computed by applying the reserve requirement ratios below to net transaction accounts, nonpersonal time deposits, and Eurocurrency liabilities of the institution during the computation period.
Federal Aviation Administration (FAA), DOT.
Final rule, delay of effective date.
This action changes the effective date of a final rule published in the
The effective date of the final rule published on September 7, 2018 (83 FR 45337) is delayed from November 8, 2018 to January 3, 2019. The Director of the Federal Register approved this incorporation by reference action under Title 1 Code of Federal Regulations part 51, subject to the annual revision of FAA Order 7400.11 and publication of conforming amendments.
Colby Abbott, Airspace Policy Group, Office of Airspace Services, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-8783.
The FAA published a final rule in the
VOR Federal airways are published in paragraph 6010(a) of FAA Order 7400.11C dated August 13, 2018, and effective September 15, 2018, which is incorporated by reference in 14 CFR 71.1. The VOR Federal airways listed in this document will be subsequently published in the Order.
Section 553(b)(3)(B) of Title 5, United States Code, (the Administrative Procedure Act) authorizes agencies to dispense with notice and comment procedures for rules when the agency for “good cause” finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under this section, an agency, upon finding good cause, may issue a final rule without seeking comment prior to the rulemaking. The FAA finds that prior notice and public comment to this final rule is unnecessary due to the brief length of the extension of the effective date and the fact that there is no substantive change to the rule.”
49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., P. 389.
Bureau of Industry and Security, Commerce.
Final rule.
In this rule, the Bureau of Industry and Security (BIS) amends the Export Administration Regulations (EAR) by adding one entity to the Entity List. The entity that is added to the Entity List has been determined by the U.S. Government to pose a significant risk of becoming involved in activities contrary to the national security or foreign policy interests of the United States. This entity will be listed under the destination of China.
Chair, End-User Review Committee, Office of the Assistant Secretary, Export
The Entity List (15 CFR, Subchapter C, part 744, Supplement No. 4) identifies entities reasonably believed to be involved, or to pose a significant risk of being or becoming involved, in activities contrary to the national security or foreign policy interests of the United States. The Export Administration Regulations (EAR) (15 CFR, Subchapter C, parts 730-774) imposes additional license requirements on, and limits the availability of most license exceptions for, exports, reexports, and transfers (in-country) to listed entities. The license review policy for each listed entity is identified in the “License review policy” column on the Entity List, and the impact on the availability of license exceptions is described in the relevant
The End-User Review Committee (ERC), composed of representatives of the Departments of Commerce (Chair), State, Defense, Energy and, where appropriate, the Treasury, makes all decisions regarding additions to, removals from, or other modifications to the Entity List. The ERC makes all decisions to add an entry to the Entity List by majority vote and all decisions to remove or modify an entry by unanimous vote.
Under § 744.11(b) (Criteria for revising the Entity List) of the EAR, persons for whom there is reasonable cause to believe, based on specific and articulable facts, have been involved, are involved, or pose a significant risk of being or becoming involved in, activities that are contrary to the national security or foreign policy interests of the United States, and those acting on behalf of such persons, may be added to the Entity List.
Pursuant to 744.11(b) of the EAR, the ERC determined that Fujian Jinhua Integrated Circuit Company poses a significant risk of becoming involved in activities that could have a negative impact on the national security interests of the United States. The ERC determined that the conduct of this entity raises sufficient concern that prior review of exports, reexports, or transfers (in-country) of items subject to the EAR involving this entity, and the possible imposition of license conditions or license denials on shipments to the entity, will enhance BIS's ability to prevent activities contrary to the national security interests of the United States.
For the one entity added to the Entity List in this final rule, BIS imposes a license requirement for all items subject to the EAR and a license review policy of presumption of denial. In addition, no license exceptions are available for exports, reexports, or transfers (in-country) to the person being added to the Entity List in this rule. The acronym “a.k.a.” (also known as) is used in entries on the Entity List to identify aliases, thereby assisting exporters, reexporters and transferors in identifying entities on the Entity List.
This final rule adds the following entity to the Entity List:
(1)
Sanchuang Park, Century Avenue, Jinjiang City, Fujian Province, China.
Shipments of items removed from eligibility for a License Exception or export or reexport without a license (NLR) as a result of this regulatory action that were en route aboard a carrier to a port of export or reexport, on October 30, 2018, pursuant to actual orders for export or reexport to a foreign destination, may proceed to that destination under the previous eligibility for a License Exception or export or reexport without a license (NLR).
On August 13, 2018, the President signed into law the John S. McCain National Defense Authorization Act for Fiscal Year 2019, which included the Export Control Reform Act of 2018 (ECRA) (Title XVII, Subtitle B of Pub. L. 115-232), which provides the legal basis for BIS's principal authorities and serves as the authority under which BIS issues this rule. As set forth in section 1768 of ECRA, all delegations, rules, regulations, orders, determinations, licenses, or other forms of administrative action that have been made, issued, conducted, or allowed to become effective under the Export Administration Act of 1979 (50 U.S.C. 4601
1. Executive Orders 13563 and 12866 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has been determined to be not significant for purposes of Executive Order 12866. This rule is not an Executive Order 13771 regulatory action because this rule is not significant under Executive Order 12866.
2. Notwithstanding any other provision of law, no person is required to respond to nor be subject to a penalty for failure to comply with a collection of information subject to the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Total burden hours associated with the PRA and OMB control number 0694-0088 are not expected to increase as a result of this rule. You may send comments regarding the collection of information associated with this rule, including suggestions for reducing the burden, to Jasmeet K. Seehra, Office of Management and Budget (OMB), by email to
3. This rule does not contain policies with Federalism implications as that term is defined in Executive Order 13132.
4. Pursuant to section 1762 of the Export Control Reform Act of 2018 (Title XVII, Subtitle B of Pub. L. 115-232), which was included in the John S. McCain National Defense Authorization Act for Fiscal Year 2019, this action is exempt from the Administrative Procedure Act (APA) (5 U.S.C. 553) requirements for notice of proposed rulemaking, opportunity for public participation, and delay in effective date.
5. Because a notice of proposed rulemaking and an opportunity for public comment are not required to be given for this rule by the APA or any other law, the analytical requirements of the Regulatory Flexibility Act, 5 U.S.C. 601,
Exports, Reporting and recordkeeping requirements, Terrorism.
Accordingly, part 744 of the Export Administration Regulations (15 CFR parts 730-774) is amended as follows:
Pub. L. 115-232, Title XVII, Subtitle B. 50 U.S.C. 4601
Environmental Protection Agency (EPA).
Final rule.
The Environmental Protection Agency (EPA) is granting final authorization to the hazardous waste program revisions submitted by North Dakota on September 20, 2016 and March 24, 2017. The EPA published a proposed rule on June 5, 2018, and provided for public comment. The comment period ended on July 5, 2018. No comments were received for this rulemaking. No further opportunity for comment will be provided. This final rule also codifies and incorporates by reference the authorized provisions of the North Dakota regulations in the Code of Federal Regulations.
This final rule is effective on October 30, 2018. The incorporation by reference of authorized provisions in the North Dakota regulations contained in this rule is approved by the Director of the Federal Register as of October 30, 2018, in accordance with 5 U.S.C. 552(a) and 1 CFR part 51.
The EPA has established a docket for this action under Docket ID No. EPA-R08-RCRA-2018-0084. All documents in the docket are listed on the
Moye Lin, Resource Conservation and Recovery Program, EPA Region 8, 1595 Wynkoop Street, Denver, Colorado 80202-1129; phone number (303) 312-6667; Email address:
North Dakota submitted a final complete program revision application on September 20, 2016, and March 24, 2017, seeking authorization of their changes in accordance with 40 CFR 271.21. We now make a final decision that North Dakota's hazardous waste program revisions satisfy all of the requirements necessary to qualify for final authorization. For a list of rules that become effective with this final rule, please see the proposed rule published in the June 5, 2018
In the proposed rule published on June 5, 2018 (83 FR 25986), the EPA also proposed to codify the EPA's authorization of North Dakota's base hazardous waste management program and the state's revisions to that program. In this action, the EPA is amending 40 CFR 272.1751 to incorporate by reference North Dakota's authorized hazardous waste statutes and regulations. In accordance with the requirements of 1 CFR 51.5, the EPA is incorporating by reference North Dakota's authorized hazardous waste statutes and regulations as described in Section I, above. The EPA has made, and will continue to make, these materials generally available electronically through
Section 272.1751 also references material which is not being incorporated by reference, but which the EPA considered in determining the adequacy of North Dakota's program. Section 272.1751(c)(2) references the demonstration of adequate authority, including procedural and enforcement provisions, which provides the legal basis for the state's implementation of the hazardous waste management program. In addition, § 272.1751(c)(5), (c)(6), and (c)(7) reference the Memorandum of Agreement, the Attorney General's Statements, and the Program Description, respectively. These documents are evaluated as part of the approval process of the hazardous waste management program in accordance with subtitle C of RCRA but are not part of the material to be incorporated by reference. The public is reminded that some provisions of North Dakota's hazardous waste program are not part of the federally-authorized state program. These non-authorized provisions include:
1. Provisions that are not part of the RCRA subtitle C program because they are “broader in scope” than RCRA subtitle C (see 40 CFR 271.1(i));
2. Federal rules for which North Dakota is not authorized, but which have been incorporated into the state regulations because of the way the state adopted federal regulations by reference;
3. State procedural and enforcement authorities which are necessary to establish the ability of the state's program to enforce compliance, but which do not supplant the federal statutory enforcement and procedural authorities.
4. Federal rules which North Dakota adopted, but which were vacated by the U.S. Court of Appeals for the District of Columbia Circuit (D.C. Cir. No. 09-1038, rulings dated July 7, 2017, and March 6, 2018).
State provisions that are “broader in scope” than the federal program are not incorporated by reference in 40 CFR part 272. For reference and clarity, the EPA lists in 40 CFR 272.1751(c)(3) the North Dakota statutory provisions that are “broader in scope” than the federal program, and which are not part of the authorized program being incorporated by reference. While “broader in scope” provisions are not part of the authorized program and cannot be enforced by the EPA, the state may enforce such provisions under state law.
North Dakota has adopted, but is not authorized for, the federal rules published in the
The Office of Management and Budget (OMB) has exempted this action from the requirements of Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011). This action authorizes and codifies state requirements for the purpose of RCRA section 3006 and imposes no additional requirements beyond those imposed by state law. Therefore, this action is not subject to review by OMB. This action is not subject to Executive Order 13771 (82 FR 9339, February 3, 2017) because today's authorization and codification of North Dakota's revised hazardous waste program under RCRA is exempted under Executive Order 12866. Accordingly, I certify that this action will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
This action also is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because it is not economically significant, and it does not make decisions based on environmental health or safety risks. This action is not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001), because it is not a significant regulatory action under Executive Order 12866.
Under RCRA 3006(b), the EPA grants a state's application for authorization as long as the state meets the criteria required by RCRA. It would thus be inconsistent with applicable law for the EPA, when it reviews a state authorization application, to require the use of any particular voluntary consensus standard in place of another standard that otherwise satisfies the requirements of RCRA. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. As required by section 3 of Executive Order 12988 (61 FR 4729, February 7, 1996), in issuing this action, the EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation and provide a clear legal standard for affected conduct. The EPA has complied with Executive Order 12630 (53 FR 8859, March 15, 1988) by examining the takings implications of the action in accordance with the “Attorney General's Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings” issued under the executive order. This action does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Executive Order 12898 (59 FR 7629, February 16, 1994) establishes federal executive policy on environmental justice. Its main provision directs federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations and low-income populations in the United States. Because this rule authorizes and codifies pre-existing state rules which are at least equivalent to, and no less stringent than existing federal requirements, and imposes no additional requirements beyond those imposed by state law, and there are no anticipated significant adverse human health or environmental effects, the rule is not subject to Executive Order 12898.
The Congressional Review Act, 5 U.S.C. 801-808, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule to each House of the Congress and to the Comptroller General of the United States. The EPA will submit a report containing this document and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication in the
Environmental protection, Administrative practice and procedure, Confidential business information, Hazardous waste, Hazardous waste transportation, Indian lands, Intergovernmental relations, Penalties, Reporting and recordkeeping requirements.
Environmental protection, Hazardous materials transportation, Hazardous waste, Incorporation by reference, Intergovernmental relations, Water pollution control, Water supply.
This rule is issued under the authority of Sections 2002(a), 3006 and 7004(b) of the Solid Waste Disposal Act as amended, 42 U.S.C. 6912(a), 6926, 6974(b).
For the reasons set forth in the preamble, under the authority at 42 U.S.C. 6912(a), 6926, and 6974(b), EPA is granting final authorization under part 271 to the State of North Dakota for revisions to its hazardous waste program under the Resource Conservation and Recovery Act and is amending 40 CFR part 272 as follows:
Sections 2002(a), 3006, and 7004(b) of the Solid Waste Disposal Act, as amended by the Resource Conservation and Recovery Act of 1976, as amended, 42 U.S.C. 6912(a), 6926, and 6974(b).
(a)
(b)
(c)
(i) The Binder entitled “EPA-Approved North Dakota Statutory and Regulatory Requirements Applicable to the Hazardous Waste Management Program,” dated April 2018.
(ii) [Reserved]
(2)
(i) North Dakota Century Code (NDCC), Volume 13A, 2012 Replacement, North Dakota Constitution, Article XI: Sections 5 and 6.
(ii) North Dakota Century Code, Volume 4A, 2012 Replacement. Chapter 23-01 “State Department of Health,” Section 23-01-04.1; Chapter 23-20.3 “Hazardous Waste Management,” Sections 23-20.3-01, 23-20.3-02 introductory paragraph, (2), (3) through (8), (10), (13) through (16), and (18); 23-20.3-03; 23-20.3-04; 23-20.3-05(3), (5), (6), and (8); 23-20.3-06 through 23-20.3-10; and Chapter 23-29 “Solid Waste Management and Land Protection,” Section 23-29-04.
(iii) North Dakota Century Code, Volume 4A, 2015 Pocket Supplement. Chapter 23-01 “State Department of Health,” Section 23-01-36.
(iv) North Dakota Century Code, Volume 5, 2012 Replacement. Chapter 28-32 “Administrative Agencies Practice Act,” Section 28-32-21.1 “Actions against administrative agencies—Attorney's fees and costs.”
(v) North Dakota Century Code, Volume 6, 2012 Replacement. Chapter 32-40 “Environmental Law Enforcement,” Sections 32-40-03 through 32-40-11.
(vi) North Dakota Century Code, Volume 9A, 2012 Replacement, as amended by the 2015 Pocket Supplement. Chapter 44-04 “Duties, records and meetings,” Sections 44-04-18 through 19.1.
(vii) North Dakota Administrative Code (NDAC), Article 33-24, Hazardous Waste Management, as amended through January 1, 2016. Sections 33-24-01-15; 33-24-01-16; 33-24-06-05, except .2.c; 33-24-06-06.2; 33-24-06-09; 33-24-06-15.1.6 through .3.b; 33-24-07-03.4; 33-24-07-04 through 33-24-07-14; 33-24-07-25 through 33-24-07-27; and 33-24-07-40 through 33-24-07-54.
(3)
(i) North Dakota Century Code, 2012 Replacement, Volume 4A, Chapter 23-01 “State Department of Health,” Section 23-01-04.1(6).
(ii) North Dakota Century Code, Volume 4A, 2012 Replacement. Chapter 23-20.3 “Hazardous Waste Management,” Sections 23-20.3-02(1); 23-20.3-05.1; 23-20.3-05.2; and 23-20.3-05.3.
(iii) North Dakota Administrative Code, Article 33-24, “Hazardous Waste Management,” as amended through January 1, 2016, Sections 33-24-01-09.4; 33-24-01-10.4; 33-24-01-19.1.d; 33-24-02-04.1.y; 33-24-03-03.4; 33-24-04-02.3; 33-24-05-02 second sentence; 33-24-06-14.3.a(4); and 33-24-06-21.
(iv) North Dakota's hazardous waste regulations set forth additional transporter requirements including permit requirements at 33-24-04-02. The transporter permit requirements are broader in scope than the federal program.
(4)
(ii) The following federal rules are not delegable to states. North Dakota has adopted these provisions and left the authority to the EPA for implementation and enforcement: Imports and Exports of Hazardous Waste: Implementation of OECD Council Decision C(92)39 Concerning the Control of Transfrontier Movements of Wastes Destined for Recovery Operations, published April 12, 1996; and Revisions to the Requirements for: Transboundary Shipments of Hazardous Wastes Between OECD Member Countries, Export Shipments of Spent Lead-Acid Batteries, Submitting Exception Reports for Export Shipments of Hazardous Wastes, and Imports of Hazardous Wastes, published January 8, 2010.
(iii) North Dakota has adopted the following federal provisions from the
(5)
(6)
(7)
(a) The statutory provisions include: North Dakota Century Code (NDCC), Volume 4A, 2012 Replacement. Chapter 23-20.3 “Hazardous Waste Management,” Sections 23-20.3-05(1), (2), (4), (7), and (9). Copies of the North Dakota statutes that are incorporated by reference are available from Matthew Bender & Company Inc., 701 E Water Street, Charlottesville, VA 22902-5389, phone number: (800) 833-9844.
(b) The regulatory provisions include: North Dakota Administrative Code (NDAC), Article 33-24, as revised January 1, 2016, except reserved provisions.
Chapter 33-24-01—General provisions: Sections 33-24-01-01 through 33-24-01-04, 33-24-01-05, except .2.k and .7.a; 33-24-01-06 through 33-24-01-09; 33-24-01-10, except .4.f; 33-24-01-11 through 33-24-01-14; 33-24-01-17; 33-24-01-18; and 33-24-01-19, except .1.d.
Chapter 33-24-02—Identification and Listing of Hazardous Waste: Sections 33-24-02-01 through 33-24-02-03; 33-24-02-04, except .1.y; 33-24-02-05; 33-24-02-06, except .1.e; 33-24-02-07 through 33-24-02-10; 33-24-02-11, except the phrase “or a miniflash continuously closed cup tester, using the test method specified in American Society for Testing and Material D6450-99 (incorporated by reference in section 33-24-01-05)” in paragraph .1.a; 33-24-02-12 through 33-24-02-19; 33-24-02-25 through 33-24-02-27; 33-24-02-33 through 33-24-02-42; 33-24-02-50 through 33-24-02-70; 33-24-02-120 through 33-24-02-129; 33-24-02-170 through 33-24-02-175; 33-24-02-180 through 33-24-02-194; 33-24-02-200 through 33-24-02-209; and Appendices I, IV, and V.
Chapter 33-24-03—Standards for Generators: Sections 33-24-03-01, except .4; 33-24-03-02; 33-24-03-03.1 and .2; 33-24-03-03.3 except the phrase “and a transporter permit”; 33-24-03-04 through 33-24-03-24; 33-24-03-30; 33-24-03-40; 33-24-03-60 through 33-24-03-77; and Appendix I.
Chapter 33-24-04—Standards for Transporters: Sections 33-24-04-01, except .4 and Note following paragraph .3.b; 33-24-04-02.1, except the phrase “, a transporter permit, and a registration certificate”; 33-24-04-02.2, except the phrases “and a registration certificate, or a transporter permit,” in the first sentence, and “and issue a registration certificate” in the second sentence; and 33-24-04-03 through 33-24-04-08.
Chapter 33-24-05—Standards for Treatment, Storage, and Disposal Facilities and for the Management of Specific Hazardous Waste and Specific Types of Hazardous Waste Management Facilities: Sections 33-24-05-01; 33-24-05-02, except the second sentence; 33-24-05-03, except 33-24-05-03.1; 33-24-05-04 through 33-24-05-10; 33-24-05-15 through 33-24-05-20; 33-24-05-26 through 33-24-05-31; 33-24-05-37; 33-24-05-38, except .1.c and .4; 33-24-05-39 through 33-24-05-44; 33-24-05-47 through 33-24-05-69; 33-24-05-74 through 33-24-05-81; 33-24-05-89 through 33-24-05-98; 33-24-05-103 through 33-24-05-115; 33-24-05-118 through 33-24-05-128; 33-24-05-130 through 33-24-05-138; 33-24-05-144 through 33-24-05-151; 33-24-05-160 through 33-24-05-170; 33-24-05-176 through 33-24-05-188; 33-24-05-201 through 33-24-05-204; 33-24-05-230, except .2.c; 33-24-05-235, except .1/Table entries (6) and (7); 33-24-05-250 through 33-24-05-253; 33-24-05-256; 33-24-05-258; 33-24-05-265; 33-24-05-266; 33-24-05-270 through 33-24-05-281; 33-24-05-282, except .2; 33-24-05-283; 33-24-05-284.8 through .13; 33-24-05-285; 33-24-05-286; 33-24-05-288 through 33-24-05-290; 33-24-05-300 through 33-24-05-303; 33-24-05-400 through 33-24-05-406; 33-24-05-420 through 33-24-05-435; 33-24-05-450 through 33-24-05-460; 33-24-05-475 through 33-24-05-477; 33-24-05-501 through 33-24-05-506; 33-24-05-525 through 33-24-05-537; 33-24-05-550 through 33-24-05-555; 33-24-05-600; 33-24-05-610 through 33-24-05-612; 33-24-05-620 through 33-24-05-624; 33-24-05-630 through 33-24-05-632; 33-24-05-640 through 33-24-05-647; 33-24-05-650 through 33-24-05-667; 33-24-05-670 through 33-24-05-675; 33-24-05-680; 33-24-05-681; 33-24-05-701 through 33-24-05-705; 33-24-05-708 through 33-24-05-720; 33-24-05-730 through 33-24-05-740; 33-24-05-750 through 33-24-05-756; 33-24-05-760 through 33-24-05-762; 33-24-05-770, except .4; 33-24-05-780; 33-24-05-781; 33-24-05-800 through 33-24-05-802; 33-24-05-820 through 33-24-05-826; 33-24-05-850; 33-24-05-855 through 33-24-05-857; 33-24-05-860; 33-24-05-865; 33-24-05-866; 33-24-05-870; 33-24-05-875; 33-24-05-880; 33-24-05-885; 33-24-05-890; 33-24-05-895 through 33-24-05-900; 33-24-05-905; 33-24-05-910; 33-24-05-915; 33-24-05-916; 33-24-05-950; 33-24-05-951; 33-24-05-960; 33-24-05-961; 33-24-05-963 through 33-24-05-968; 33-24-05-980 through 33-24-05-986; 33-24-05-990 through 33-24-05-998; 33-24-05-1010 through 33-24-05-1016; 33-24-05-1020; 33-24-05-1031; 33-24-05-1040 through 33-24-05-1043; 33-24-05-1045 through 33-24-05-1047; 33-24-05-1060 through 33-24-05-1063; 33-24-05-1067; 33-24-05-1068; 33-24-05-1071; 33-24-05-1080 through 33-24-05-1087; 33-24-05-1100 through 33-24-05-1114; 33-24-05-1130 through 33-24-05-1138; and Appendices I through VIII, X through XIII, XV through XXIV, and XXVI through XXIX.
Chapter 33-24-06—Permits: Sections 33-24-06-01; 33-24-06-02, 33-24-06-03, except Note following paragraph .1.a.(2); 33-24-06-04; 33-24-06-05.2.c; 33-24-06-06.1; 33-24-06-07; 33-24-06-08; 33-24-06-10 through 33-24-06-13; 33-24-06-14, except .3.a.(4); 33-24-06-15 introductory paragraph through .1.a; 33-24-06-16.5 through .7; 33-24-06-17 through 33-24-06-20; 33-24-06-30 through 33-24-06-35; 33-24-06-45; 33-24-06-48; 33-24-06-52; 33-24-06-56; 33-24-06-57; 33-24-06-62; 33-24-06-65; 33-24-06-70; 33-24-06-73; 33-24-06-76; 33-24-06-80; 33-24-06-85; 33-24-06-100; and Appendix I to Section 33-24-06-14.
Chapter 33-24-07—Permitting Procedures: Sections 33-24-07-01; 33-24-07-02; and 33-24-07-03, except .4.
Copies of the North Dakota regulations that are incorporated by reference are available from North Dakota Legislative Counsel, Second Floor, State Capitol, 600 East Boulevard Avenue, Bismarck, North Dakota 58505, phone number: (701) 328-2916.
Food and Drug Administration, HHS.
Notification; petition for rulemaking.
The Food and Drug Administration (FDA or we) is announcing that Zinpro Corp. has filed a petition proposing that the food additive regulations be amended to provide for the safe use of silicon dioxide as an anticaking agent for the use with zinc-L-selenomethionine as a feed component.
The food additive petition was filed on July 29, 2014.
For access to the docket, go to
Carissa Doody, Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-6283,
Under the Federal Food, Drug, and Cosmetic Act (section 409(b)(5) (21 U.S.C. 348(b)(5))), notice is given that a food additive petition (FAP 2285) has been filed by Zinpro Corp., 10400 Viking Dr., Suite 240, Eden Prairie, MN 55344. The petition proposes to amend Title 21 of the Code of Federal Regulations (CFR) in part 573 (21 CFR part 573)
The petitioner has claimed that this action is categorically excluded under 21 CFR 25.32(r) because it is of a type that does not individually or cumulatively have a significant effect on the human environment. In addition, the petitioner has stated that, to their knowledge, no extraordinary circumstances exist. If FDA determines a categorical exclusion applies, neither an environmental assessment nor an environmental impact statement is required. If FDA determines a categorical exclusion does not apply, we will request an environmental assessment and make it available for public inspection.
Food and Drug Administration, HHS.
Notification; petition for rulemaking.
The Food and Drug Administration (FDA or we) is announcing that Adisseo France S.A.S. has filed a petition proposing that the food additive regulations be amended to provide for the safe use of silicon dioxide as a carrier for selenomethionine hydroxy analogue at a level not to exceed 95 percent of the selenomethionine hydroxy analogue in its packaged form.
The food additive petition was filed on June 18, 2015.
For access to the docket, go to
Chelsea Trull, Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-6729,
Under the Federal Food, Drug, and Cosmetic Act (section 409(b)(5) (21 U.S.C. 348(b)(5))), notice is given that a food additive petition (FAP 2291) has been filed by Adisseo France S.A.S., Immeuble Antony Parc II, 10 Place du Général de Gaulle, 92160 Antony, France. The petition proposes to amend Title 21 of the Code of Federal Regulations (CFR) in part 573 (21 CFR part 573)
The petitioner has claimed that this action is categorically excluded under 21 CFR 25.32(r) because it is of a type that does not individually or cumulatively have a significant effect on the human environment. In addition, the petitioner has stated that, to their knowledge, no extraordinary circumstances exist. If FDA determines a categorical exclusion applies, neither an environmental assessment nor an environmental impact statement is required. If FDA determines a categorical exclusion does not apply, we will request an environmental assessment and make it available for public inspection.
Internal Revenue Service (IRS), Treasury.
Proposed rule; notice of hearing.
This document provides a notice of public hearing on proposed regulations relating to guidance regarding the additional first year depreciation deduction under section 168(k) of the Internal Revenue Code.
The public hearing is being held on Wednesday, November 28, 2018, at 10:00 a.m. The IRS must receive speakers' outlines of the topics to be discussed at the public hearing by Thursday, November 15, 2018.
The public hearing is being held in the IRS Auditorium, Internal Revenue Service Building, 1111 Constitution Avenue NW, Washington, DC 20224. Due to building security procedures, visitors must enter at the Constitution Avenue entrance. In addition, all visitors must present a valid photo identification to enter the building.
Send Submissions to CC:PA:LPD:PR (REG-104397-18), Room 5205, Internal Revenue Service, P.O. Box 7604, Ben Franklin Station, Washington, DC 20044. Submissions may be hand-delivered Monday through Friday to CC:PA:LPD:PR (REG-104397-18), Couriers Desk, Internal Revenue Service, 1111 Constitution Avenue NW, Washington, DC 20224 or sent electronically via the Federal eRulemaking Portal at
Concerning the proposed regulations, Elizabeth R. Binder, (202) 317-7005; concerning submissions of comments, the hearing and/or to be placed on the building access list to attend the hearing, Regina Johnson at (202) 317-6901 (not toll-free numbers).
The subject of the public hearing is the notice of proposed rulemaking (REG-104397-18) that was published in the
The rules of 26 CFR 601.601(a)(3) apply to the hearing. Persons who wish to present oral comments at the hearing that submitted written comments by October 9, 2018, must submit an outline of the topics to be addressed and the amount of time to be devoted to each topic by Thursday, November 15, 2018.
A period of 10 minutes is allotted to each person for presenting oral comments. After the deadline for receiving outlines has passed, the IRS will prepare an agenda containing the schedule of speakers. Copies of the agenda will be made available, free of charge, at the hearing or by contacting the Publications and Regulations Branch at (202) 317-6901 (not a toll-free number).
Because of access restrictions, the IRS will not admit visitors beyond the immediate entrance area more than 30 minutes before the hearing starts. For information about having your name placed on the building access list to attend the hearing, see the
Environmental Protection Agency (EPA).
Proposed rule.
In this action, the Environmental Protection Agency (EPA) proposes to amend the 2016 Emission Guidelines and Compliance Times for Municipal Solid Waste Landfills (“MSW Landfills EG”). The requirements for state and federal plans implementing the MSW Landfills EG were adopted from 1975 regulations, referred to herein as the “old implementing regulations,” which are cross-referenced in the MSW Landfill EG. In a separate regulatory proposal published in the
•
•
•
•
For questions about this proposed action, contact Andrew Sheppard, Sector Policies and Programs Division (E143-03), Office of Air Quality Planning and Standards, U.S. Environmental
The EPA may publish any comment received to its public docket. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission (
The
Table 1 of this preamble lists the source categories that may be affected
In addition to being available in the docket, an electronic copy of this action is available on the internet. Following signature by the EPA Administrator, the EPA will post a copy of this proposed action at
On August 29, 2016, the EPA published a final rule titled “Emission Guidelines and Compliance Times for Municipal Solid Waste Landfills” (the “MSW Landfills EG”), under Clean Air Act (CAA) section 111(d) (81 FR 59276). Section 111(d) is the provision of the CAA that governs the establishment of performance standards for existing sources. The MSW Landfills EG, which was promulgated as a new subpart at 40 CFR part 60, subpart Cf, updated the control requirements and monitoring, reporting, and recordkeeping provisions for existing MSW landfill sources. The MSW Landfills EG incorporates by cross-reference or direct adoption certain requirements for state and federal plans as specified in 40 CFR part 60, subpart B. Subpart B at 40 CFR part 60 contains the historic regulations, initially promulgated in 1975 to implement CAA section 111(d), that established generally applicable procedural and substantive requirements for CAA section 111(d) regulations (the “old implementing regulations”). Under the old implementing regulations at 40 CFR 60.23(a) as adopted by the MSW Landfills EG, state plans were due 9 months after the August 29, 2016, publication date of the MSW Landfills EG. Thus, states were required to submit their plans to the EPA by May 30, 2017.
On August 31, 2018, as part of the proposed Affordable Clean Energy (ACE) rule (a CAA section 111(d)-rule addressing greenhouse gas emissions from fossil-fuel-fired electric generating units), the EPA proposed revisions to the old implementing regulations for all CAA section 111(d) emission guidelines (83 FR 44746). Specifically, the proposed ACE rule included a new regulation at 40 CFR part 60, subpart Ba (“proposed new implementing regulations”) that would, among other things, change the timing requirements for the submission of state plans, the EPA's review of state plans, and the issuance of federal plans to more closely align the procedures to that provided under CAA section 110 as specified in CAA section 111(d)(1).
In the proposed ACE rule, the EPA proposed to apply the 40 CFR part 60, subpart Ba timing requirements to all “ongoing” emission guidelines already published under CAA section 111(d) (83 FR 44769). However, the EPA recognizes that, without further action, the promulgation of the proposed new implementing regulations would not be sufficient to change the timing requirements for the MSW Landfills EG, even though it is an ongoing CAA section 111(d) action. This is because the MSW Landfills EG includes a cross-reference to the old implementing regulations, as well as a specific deadline for the submission of state plans that was based on the timing requirements in the old implementing regulations. The EPA is proposing to amend the cross-references and deadline in the MSW Landfills EG to align with the proposed timing requirements in 40 CFR part 60, subpart Ba.
Specifically, the EPA is proposing to amend the MSW Landfills EG regulatory text in 40 CFR part 60, subpart Cf to adjust the state plan due date from May 30, 2017, to August 29, 2019, which aligns with the proposed new timing requirements in 40 CFR part 60, subpart
As explained in the proposed ACE rule, CAA section 111(d)(1) directs the EPA to promulgate regulations establishing a procedure “similar to” that under CAA section 110 (governing the development, submission, and EPA review of SIPs to address National Ambient Air Quality Standards) for states to submit plans to the EPA that establish standards of performance for existing sources (
Separate and apart from the interaction between the text of CAA section 111(d) and the 1990 amendments to CAA section 110, the EPA's experience also has shown that states need more time to submit a plan than provided for in the old implementing regulations at 40 CFR part 60, subpart B. When the EPA proposed the MSW Landfills EG, some commenters objected to the 9-month period to submit a state plan as not being achievable for a number of reasons, such as the amount of time needed for rule development, public outreach, public notice, and to hold a public hearing for rule adoption. Commenters recommended allowing states varying amounts of time, from 12 to 24 months, to submit a state plan. (
In addition, as explained in the proposed ACE rule, CAA section 111(d)(2)(A) authorizes the EPA to prescribe a plan for a state “in cases where the State fails to submit a satisfactory plan.” The EPA, therefore, is charged with determining whether state plans developed and submitted under CAA section 111(d)(1) are “satisfactory.” The EPA reiterates the position in the proposed ACE rule that, given the flexibilities that CAA section 111(d) and emission guidelines generally accord to states, and the EPA's prior experience on reviewing and acting on SIPs under CAA section 110, it is appropriate to extend the period for the EPA's review and approval or disapproval of plans from the 4-month period provided in 40 CFR part 60, subpart B, to the 12-month period (after a determination of completeness, either affirmatively by the EPA or by operation of law) provided in the proposed new implementing regulations. This timeline would provide adequate time for the EPA to review plans and follow notice-and-comment rulemaking procedures to ensure an opportunity for public comment on the EPA's proposed action on a state plan (
Finally, for this proposed action, the EPA is reiterating the rationale in the proposed ACE rule for extending the timing from 6 months to 2 years for the EPA to promulgate a federal plan for states that fail to submit an approvable state plan in response to the MSW Landfills EG. This 2-year timeline is consistent with the federal implementation plan deadline under CAA section 110(c) (s
In summary, under this proposed rule, which would adopt the timing requirements in proposed 40 CFR part 60, subpart Ba, states would have until August 29, 2019, to submit their state plans (3 years from the effective date of the MSW Landfills EG). After a state has submitted its plan, the EPA would have 6 months to determine if the plan is complete. If the EPA does not make a determination of completeness within that period of time, the state plan would be deemed complete by operation of law, and the EPA would have 12 additional months to approve or disapprove the state plan. If the EPA determines that the plan is complete, the EPA would have 12 months from the date of that determination to approve or disapprove the state plan. If the EPA determines that the plan is incomplete, the EPA would have 2 years to promulgate a federal plan. Similarly, if the EPA disapproves a state plan (even one that met the completeness requirements), the EPA would have 2 years to promulgate a federal plan. However, a state would always be able to submit a revised state plan that corrects the deficiencies, and, depending on the timing, the EPA could either approve that plan before promulgating a federal plan or, if a federal plan had already been promulgated, approve it and withdraw the federal plan.
Although the costs and benefits of harmonizing the timing requirements of state plans cannot be quantified due to inherent uncertainties, the EPA believes that they will be minimal and requests comment on this. Some facilities may have an incentive to install landfill gas collection systems. Landfill gas can be recovered and used as an energy source, either offsetting existing energy costs or providing a source of revenue. This offers financial advantages for some facilities to install landfill gas collection systems early in the development of the project (
For states, the costs of complying with the new timing requirements, which include the new completeness criteria, are likely minimal.
In summary, the purpose of this proposal is to amend the MSW Landfills EG to align the timing requirements in the EG, which were adopted from the old implementing regulations, with the timing and completeness checklist requirements in the proposed new implementing regulations at 40 CFR part 60, subpart Ba (
Additional information about these statutes and Executive Orders can be found at
This action is a significant regulatory action that was submitted to the Office of Management and Budget (OMB) for review. Any changes made in response to OMB recommendations have been documented in the docket.
This action is not expected to be subject to Executive Order 13771 because this proposed rule is expected to result in no more than
This action does not impose any new information collection burden under the PRA. OMB has previously approved the information collection activities contained in the existing regulations and has assigned OMB control number 2060-0720. Because the burden to prepare and submit a state plan have been fully incorporated into the 2016 MSW Landfills EG, and this action does not change any of the requirements associated with the stringency of the rule, there are no changes to the previously estimated information collection burden.
I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. This action proposes a technical amendment to the MSW Landfills EG promulgated in 2016, which was determined not to impose any requirements on small entities due to the fact that emission guidelines established under CAA section 111(d) do not impose any requirements on regulated entities and, thus, will not have a significant economic impact
This action does not contain any unfunded mandate as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments.
The action implements mandate(s) specifically and explicitly set forth in 40 CFR part 60, subpart Ba without the exercise of any policy discretion by the EPA.
This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.
This action does not have tribal implications, as specified in Executive Order 13175. The MSW Landfills EG recognized that one tribe had three landfills that may potentially be subject to the emission guidelines, but noted that these landfills have already met requirements under the previous new source performance standards/emission guidelines framework as promulgated in 1996 (
This action is not subject to Executive Order 13045 because it is not economically significant as defined in Executive Order 12866, and because the EPA does not believe the environmental health or safety risks addressed by this action present a disproportionate risk to children. This regulatory action is a procedural change and does not have any impact on human health or the environment. Thus, it will not disproportionately affect children.
This action is not a “significant energy action” because it is not likely to have a significant adverse effect on the supply, distribution, or use of energy. Further, we have concluded that this action is not likely to have any adverse energy effects because it is a procedural change and does not have any impact on energy supply, distribution, or use.
This rulemaking does not involve technical standards.
The EPA believes that this action is not subject to Executive Order 12898 (59 FR 7629, February 16, 1994) because it does not establish an environmental health or safety standard. This regulatory action is a procedural change and the EPA does not anticipate that it will have any material impact on human health or the environment.
Environmental protection, Administrative practice and procedures, Emission guidelines, Landfills, Reporting and recordkeeping requirements, State plan.
For the reasons stated in the preamble, the Environmental Protection Agency proposes to amend part 60 of title 40, chapter I, of the Code of Federal Regulations as follows:
42 U.S.C. 7401
(a) If you are the Administrator of an air quality program in a state or United States protectorate with one or more existing municipal solid waste landfills that commenced construction, modification, or reconstruction on or before July 17, 2014, you must submit a state plan to the U.S. Environmental Protection Agency (EPA) that implements the Emission Guidelines contained in this subpart. The requirements for state and federal plans are specified in 40 CFR part 60, subpart B with the exception that §§ 60.23 and 60.27 will not apply. The following requirements apply instead:
(1) Notwithstanding the provisions of § 60.20a(a) in 40 CFR part 60, subpart Ba, the requirements of §§ 60.23a and 60.27a will apply for state and federal plans, except that the requirements of § 60.23a(a)(1) will apply to a notice of availability of a final guideline document that was published under § 60.22(a); and
(2) The requirements of § 60.27a(e)(1) will refer to a final guideline document that was published under § 60.22(a) and the requirements of § 60.27a(e)(2) will refer to § 60.24(f).
(b) You must submit a state plan to the EPA by August 29, 2019.
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA or the “Agency”) has reviewed changes to the North Dakota Air Pollution Control Rules. Concluding review of those changes, the EPA is proposing interim approval of revisions to the North Dakota operating permit program for stationary sources subject to title V of the Clean Air Act (CAA or the “Act”) and recodification of the title V program under a new title of the North Dakota Administrative Code (NDAC). This document also proposes approval
Written comments must be received on or before November 29, 2018.
Submit your comments, identified by Docket ID No. EPA-R08-OAR-2018-0299 at
Gregory Lohrke, Air Program, EPA, Region 8, Mailcode 8P-AR, 1595 Wynkoop Street, Denver, Colorado 80202-1129; (303) 312-6396;
The North Dakota Century Code (NDCC) currently designates the NDDH as the primary state environmental agency (NDCC 23-01). The North Dakota health department's authority to administer and implement the North Dakota Air Pollution Control Rules is codified in NDAC Article 33-15. On April 7, 2017, the Governor of North Dakota signed legislation to amend the NDCC for the creation of the NDDEQ and initiate the transfer of all authority, powers and duties of the NDDH related to environmental quality to the new Department.
After the EPA receives a program revision, the Administrator shall approve or disapprove program revisions based on the requirements of part 70 and the Act.
Title V of the 1990 CAA amendments directed the EPA to develop and promulgate rules that define the necessary elements of an approvable state operating permits program and the necessary standards and procedures by which the EPA will approve, oversee, and, when necessary, withdraw approval of a state's permitting authority under such programs. These operating permit program requirements are codified at 40 CFR part 70 (part 70). Title V also directs states to develop and submit to the EPA approvable programs for the issuance of operating permits to all major stationary sources and to certain other sources within the state's jurisdiction. Part 70 includes the procedure for state requests to the EPA for approval of revisions to the state's operating permit program (§ 70.4(i)), and for EPA approvals of partial or complete transferal of permitting authority from one state agency to another (§ 70.4(i)(2)).
North Dakota received interim approval of its operating permit program effective on August 7, 1995 (60 FR 35335). The State later received final, full approval effective on August 16, 1999 (64 FR 32433). On August 6, 2018, the State of North Dakota submitted to the EPA a formal request for approval of all operating permit program recodifications and revisions, for transferal of permitting authority to the NDDEQ, along with requests for approvals of delegations of authority for other related programs under the Act (
The EPA finds the State of North Dakota's modified operating permits program submittal to be administratively complete for requesting approval of recodification and revisions to the State's program and the transfer of all authorities related to the permitting program to the newly created NDDEQ. This determination was made with reference to the criteria for administrative completeness found in 40 CFR part 70. An accounting of specific, required submittal elements for revisions to state operating permit programs and transfers of authority to new state agencies are in 40 CFR 70.4(i)(2). This section specifies the submittal requirements for any state-initiated program revision as being: (1) A modified program description; (2) an Attorney General's statement; and (3) such other documents as EPA determines to be necessary (70.4(i)(2)(i)). Additional evaluation criteria specific to initial program submittals, used as supplemental criteria in the EPA's review of the necessary submittal elements, are found under § 70.4(b).
As required under 40 CFR 70.4(i)(2)(i), the State of North Dakota included in its request for approval of revisions to its operating permit program a description of how the NDDEQ intends to carry out its responsibilities under part 70 and title V of the CAA (see criteria for program descriptions at § 70.4(b)(1)). The State's program description outlines both the basis for operating permit program implementation and the organizational structure of the NDDEQ's Division of Air Quality. The program description also includes job classification descriptions for all staff positions responsible for carrying out the operating permits program under the NDDEQ's air quality division. Implementation of the North Dakota title V program will be based on implementation authority granted by the relevant sections of NDAC article 33.1-15, as submitted to the EPA for review.
Title 40 CFR 70.4(b)(3) enumerates the necessary elements of the Attorney General's statement required for program revisions covered by § 70.4(i)(2)(i). These elements are necessary to ensure that the State operating permit authority receiving transfer of the title V program has the complete legal authority to carry out the requirements of a part 70 program. This includes, but is not limited to, the authority to: Issue permits and assure source compliance with each applicable requirement and requirement of part 70; incorporate monitoring, recordkeeping, reporting and compliance certification
North Dakota's Attorney General's statement provides descriptions of the legal authority under the recodified laws and regulations of the State to carry out all aspects of an operating permits program, including the authority to carry out each of these preceding elements.
During North Dakota's review of the NDAC for recodification and submittal to the EPA, the State discovered limitations on the opportunity for judicial review in State courts. The EPA regulation for state operating permit programs outlines the conditions and requirements for granting affected parties the opportunity to appeal for judicial review in state courts (40 CFR 70.4(b)(3)(x)-(xii)). The Attorney General's opinion explains that while State law provides for opportunity for judicial review for most of the requirements in 40 CFR 70.4(b)(3)(x)-(xii), the provisions are overly limited. The opinion explains that the State intends to revise its rules to remedy the limitations on judicial review:
Forthcoming Department rules will provide that if the final permit action being challenged is the Department's failure to take final action, a petition for judicial review may be filed at any time before the Department denies the permit or issues the final permit; and that where petitions for judicial review are based solely on grounds arising after the 30-day deadline for judicial review, such petitions may be filed no later than 30 days after the new grounds for review arise.
The statement concludes by explaining that “an addendum to the opinion will be submitted once these rules are adopted.” Therefore, while State law grants the Department authority to grant petitioners the right to some opportunities for judicial review, Department rules limit the full authority required under 40 CFR 70.4(b)(3)(x)-(xii) (NDCC §§ 23.1-01-11, 23.1-06-04(1)(l), 28-32-42; NDAC § 33.1-15-14-06(8)). The EPA proposes to find that the Attorney General's statement is appropriate and consistent with the transfer of authority, except for the limitations on judicial review under title V and § 70.4(b)(3)(x)-(xii) described in the Attorney General's opinion. The effects of these limitations on the EPA's proposed action are discussed in section II.C of this document.
The transfer of permitting program authorities to the newly created Department will be accompanied by a transfer of all related program operations as they have existed under the authority of the NDDH. Since the North Dakota title V program is reasonably assumed to operate in the future as it has since full program approval in 1999, the EPA asked for no additional supporting documents, such as would be required for initial program submittals under 40 CFR 70.4(b)(4)-(16), except for the relevant NDCC and NDAC sections as revised and recodified for program transfer. With the exception to the revisions needed to the regulations discussed in section II.B.4 of this notice, we propose to find that the recodified regulations are substantively equal to those the EPA previously approved for implementation and enforcement of the State's operating permit program, the structure and operations of the implementing authority can be assured to continue in a similar, adequate manner as they did under the NDDH, and the relevant NDCC and NDAC sections are appropriate and consistent with the transfer of authority.
Since the full approval of North Dakota's title V operating permit program in 1999 (64 FR 32433), the State has made several minor changes to the section of North Dakota regulations that provide the legal authority to implement and enforce such a program. North Dakota made most of these amendments to NDAC section 33-15-14-06 to bring its regulations into alignment with the federal part 70 operating permit program requirements as amended between 1999 and the present.
• Under subsection 1 (“Definitions”), three paragraphs were added to reflect the EPA's amendments to 40 CFR 70.2. Two paragraphs add new definitions for “Approved replicable methodology (ARM)”
• Under subsection 4 (“Permit applications”), several paragraphs, along with specific language, were removed relating to the timeline for initial title V permit applications, which the State explains no longer apply to any source in North Dakota and are no longer necessary. Two paragraphs were added to specify requirements for a description and compliance schedule for source requirements associated with a proposed AOS, to be included in the compliance plan for all title V sources submitting operating permit applications (paragraphs 4.c.(8)(b)[4] and (c)[4]). The State made these additions, as well as limited revisions to various paragraphs (33-15-14-06.4.c(2), (3)(c) and (7)) under this subsection,
• Under subsection 5 (“Permit content”), North Dakota revised the language of paragraphs a.(1) and a.(9) to account for the EPA's revisions to various part 70 requirements attendant to the addition of definitions for ARM and AOS. These changes were made in accordance with the EPA's 2009 revisions to part 70 regulations (74 FR 51417). These two paragraphs incorporate paragraphs 40 CFR 70.6(a)(1) and (a)(9), as revised in 2009 with minor terminology changes to accommodate reference to the North Dakota Program instead of a generalized state program. The State also revised language under paragraph c.(5)(c)[2] of this subsection to clarify and update compliance certification requirements in accordance with the EPA's 2014 revisions to section 70.6 (79 FR 43661). This paragraph incorporates 40 CFR 70.6(c)(5)(iii)(B), as revised in 2014 with minor terminology changes to accommodate reference to the North Dakota Program and the State's air quality control rules instead of a generalized state program and the CFR;
• Under subsection 8 (“Judicial review of title V permit to operate decisions”), the State added the subsection by adding paragraphs 8.a through 8.e to codify most of the legal authority to provide judicial review of permit decisions as required of state operating permit programs and described under section 70.4(b)(3)(x)-(xii); and
• Under subsection 10 (“Compliance assurance monitoring”), North Dakota incorporated by reference the compliance assurance monitoring (CAM) regulations of 40 CFR part 64 with minor revisions to three definitions used in part 64 to insure the State's delegated implementation and enforcement authority regarding those regulations.
• Additionally, the EPA promulgated amendments to the part 70 regulations that North Dakota has not adopted and the EPA proposes to find that is was not necessary for the State to adopt these amendments.
North Dakota's revised title V program submittal includes all amendments to NDAC section 33-15-14-06 as they have been incorporated into the recodification of North Dakota's title V permitting regulations at NDAC 33.1-15-14-06. These amendments were made to either directly reflect the EPA's amendments to the federal part 70 regulations during the years since North Dakota's full program approval (64 FR 32433) or as North Dakota-specific amendments. All of the State's amendments, except for those to NDAC subsection 33-15-14-06.8 and its successor, the limitations of which are discussed in section II.B.2 of today's notice, are found to be approvable. Many of these changes were made to bring state regulations into accord with the EPA's changes to part 70 requirements over that time period. The remaining changes to NDAC 33-15-14-06 were not in response to modified federal regulations; however, the State's changes do not create an operating permits program any less stringent than is required under 40 CFR part 70. We propose to find that all previously unapproved amendments to the North Dakota Program between full approval and the transfer of authority to the NDDEQ, as they have been recodified under NDAC 33.1-15-14-06, are approvable for the purposes of part 70 program implementation and enforcement.
North Dakota's request for transfer of the title V operating permit program includes the request to transfer associated State responsibilities for the CAA title IV Acid Rain Program (40 CFR parts 72, 75 and 76).
North Dakota's program meets the minimum requirements and otherwise substantially meets the part 70 requirements,
Section 112 of the CAA authorizes the EPA to develop and periodically revise a list of all categories and subcategories of major sources and area sources of hazardous air pollutants (HAP). To reduce HAP emissions from these sources, this section of the Act also authorizes the EPA to promulgate federally enforceable NESHAP and MACT requirements for source categories. The NESHAP and MACT requirements are promulgated in parts 61 and 63 of title 40 of the CFR. Section 112(l) of the Act provides a mechanism for approval of programs and delegation of authority to the states to implement and enforce these federal standards and requirements. A state's program may provide for partial or complete delegation of the Agency's authorities and responsibilities to implement and enforce section 112 standards and requirements, so long as those authorities are carried out by an approvable state program with standards and requirements no less stringent than those promulgated by the EPA. The regulations found in 40 CFR part 63, subpart E establish procedures consistent with section 112(l) for the approval of state rules, programs, or other requirements, as well as procedures for the delegation of authority to states to implement and enforce all section 112 federal rules as promulgated, without changes, after their incorporation into state code (40 CFR 63.91).
North Dakota first received straight delegation of authority to implement and enforce NESHAP and MACT requirements on July 7, 1995 (60 FR 35335) upon the parallel interim approvals of the State's section 112 implementation and enforcement plan and the State's title V program.
The NDDH's planned transfer of authorities pursuant to State law to a new State agency required minor revisions and the recodification of State rules and its section 112 program for implementation and enforcement of NESHAP and MACT requirements. The recodification of the State's program requires the State provide the Agency with a copy of the revised authorities and a formal request for approval measured against the criteria for approval found under 40 CFR 63.91(d) and any additional relevant approval criteria in 40 CFR part 63, subpart E.
In a letter dated August 6, 2018, North Dakota submitted to the EPA final revisions to the State's Air Pollution Control Rules pertaining to administration, implementation and enforcement of CAA section 112 emissions standards and requirements by the new NDDEQ. This letter included a request to approve straight delegation of all NESHAP and MACT requirements incorporated unchanged into the recodified State regulations, and a submittal package justifying the approvability of the State's revised section 112 program. The EPA reviewed the State's program and recodified incorporations of federal requirements (NDAC chapters 33.1-15-12 and 33.1-15-22) for equivalency to the formerly approved implementation and enforcement program and former codification of federal requirements (NDAC chapters 33-15-12 and 33-15-22). The EPA also evaluated the submittal for approvability on the program's own merits as measured against the approval criteria found in subpart E of 40 CFR part 63. Additionally, we evaluated North Dakota's request for section 112 program approval based on the nine elements in the EPA's 1983 “Good Practices Manual for Delegation of NSPS and NESHAPs”: (1) Emission limits consistent with Federal regulations; (2) test methods consistent with federal regulations; (3) reporting and monitoring requirements; (4) enforcement; (5) waiver procedures; (6) surveillance; (7) public notification and disclosure of information; (8) resources; and (9) reporting to EPA.
Referring to a state's title V program final approval would normally satisfy the common approval criteria set forth for straight delegation of section 112 authorities to the state (40 CFR 63.91(d)(3)). However, North Dakota's title V program also underwent recodification during the proposed transfer of authority to the NDDEQ and was revised since EPA's final approval. Notice of proposed rulemaking action on the recodifications and revisions to North Dakota's title V program is found in Section II of today's proposed rulemaking document. Due to the concurrent nature of the title V revisions and recodifications and section 112 program recodifications and of the EPA's simultaneous review of those revisions, the EPA evaluates the section 112 program recodifications against the criteria for stand-alone up-front completeness and approvability.
The North Dakota request for section 112 program approval was measured for completeness against all up-front approval criteria found under 40 CFR 63.91(d). These criteria as they were fulfilled by the State of North Dakota are: (1) A written finding by the State Attorney General that the NDDEQ has the necessary legal authority to implement and enforce the State's rules and source requirements upon program approval and to assure compliance by all sources within the State of North Dakota with each applicable section 112 standard or requirement (§ 63.91(d)(3)(i));
North Dakota provides the required items of 40 CFR 63.91(d)(3), and so fulfills the section 112 program submittal criteria set out by that section and the EPA's 1983 Manual, as outlined below.
1. With respect to the State's legal authority to implement and enforce a section 112 program in the manner required under § 63.91(d)(3)(i): Sections VI, VII, XIV and XXII of the Attorney General's Opinion provides reference to the statutory source of the State's implementation and enforcement authority for administering a section 112 program.
2. Pursuant the requirement of § 63.91(d)(3)(ii) that the submittal include a copy of all statutes, regulations, and requirements containing the appropriate provisions granting the authority to implement and enforce the state's section 112 program, including the related requirements in the EPA's 1983 Good Practices Manual (program elements 1-7)
3. Pursuant the requirement of § 63.91(d)(3)(iii) that the State show adequate resources to implement and enforce all aspects of a section 112 program, the State notes in its submittal that the NDDEQ will be funded and staffed at the same level as the Environmental Health Division of the NDDH which previously carried out all aspects of the section 112 program.
4. Pursuant to the requirements of §§ 63.91(d)(3)(iv) and (v), which require a demonstration of planned expeditious implementation and enforcement of the section 112 program, the State's submittal quotes a specific provision of Senate Bill 2327 that specifies that all “orders, determinations, and permits” made by the NDDH before the transfer of authority remain in effect. The NESHAPs and MACT Program Descriptions provide additional details regarding program implementation. As there will be a continuity in the orders, determinations and permit conditions that compose the section 112 program, there is no further need for implementation schedules or compliance plans as would be needed in an initial program approval. Pursuant to the EPA's 1983 Best Practices Manual program element for reporting to the EPA, the NESHAP and MACT Program Descriptions explain that the DEQ will report to the EPA as required by the Performance Partnership Agreement (PPA)
North Dakota's request included NESHAP in 40 CFR part 61 as they existed on July 2, 2010, and in 40 CFR part 63 as they existed through July 1, 2015.
The NDDEQ would maintain primary responsibility for the enforcement of the delegated section 112 standards within the State. If the NDDEQ determines that such enforcement is not feasible and so notifies the EPA, or on the occasion of the NDDEQ acting in a manner incongruous with the terms of this delegation arrangement, the EPA may exercise its parallel enforcement authority pursuant section 113 of the CAA with respect to sources within North Dakota subject to the section 112 hazardous air pollutant standards.
Additionally, some portions of the NESHAP/MACT standards and the associated general provisions may not be delegated to a state. The EPA retains authority over those portions of the section 112 standards and associated general provisions which may not be delegated. In general, the EPA will delegate to a state the authority to make decisions which are not likely to be nationally significant or to alter the stringency of the underlying standard. Pursuant to this goal, the EPA has codified those part 63 general provisions which may, and may not, be delegated to a state in 40 CFR 63.91(g). The EPA's complete reasoning for defining those provisions which are and are not delegable may be found in EPA's July 10, 1998 memorandum
If this delegation is finalized, all questions concerning implementation and enforcement of the excluded standards in the State of North Dakota
If this NESHAP delegation is finalized, the State will obtain concurrence from the EPA on any matter involving the interpretation of section 112 of the CAA or 40 CFR parts 61 and 63 to the extent that implementation or enforcement of these provisions have not been covered by prior EPA determinations or guidance.
The EPA retains the right, as provided by CAA section 112(l)(7) and 40 CFR 63.90(d)(2), to enforce any applicable emission standard or requirement under section 112. In addition, the EPA may enforce any federally approved state rule, requirement, or program under 40 CFR 63.90(e) and 63.91(c)(1)(i). The EPA also has the authority to make certain decisions under the General Provisions (subpart A) of parts 61 and 63. In addition, the EPA may review and disapprove state determinations and subsequently require corrections.
In addition to the information identified in the Performance Partnership Agreement, the State must provide any additional compliance related information to the EPA Region 8 Air Program within 45 days of a request under 40 CFR 63.96(a). In receiving delegation for specific General Provisions authorities, the State must submit to the EPA Region 8 on a semi-annual basis, copies of determinations issued under these authorities.
The EPA oversees a state's decisions to ensure the delegated authorities are being adequately implemented and enforced. We will integrate oversight of the delegated authorities into the existing mechanisms and resources for oversight currently in place. If, during oversight, we determine that the State made decisions that decreased the stringency of the delegated standards, then the State shall be required to take corrective actions and the source(s) affected by the decisions will be notified, as required by 40 CFR 63.91(g)(1)(ii) and (b). We will initiate withdrawal of the program or rule if the corrective actions taken are insufficient.
For the delegated NESHAP standards and authorities covered by this proposed action, if finalized, sources would submit all of the information required pursuant to the general provisions and the relevant subpart(s) of the delegated NESHAP (40 CFR parts 61 and 63) directly to the State. The State is the primary point of contact with respect to delegated NESHAPs. Sources do not need to send a copy to the EPA. The EPA Region 8 proposes to waive the requirement that notifications and reports for delegated standards be submitted to the EPA in addition to the State in accordance with 40 CFR 63.9(a)(4)(ii) and 63.10(a)(4)(ii).
As stated in previous NESHAP delegation actions, the EPA has approved North Dakota's mechanism of incorporation by reference of NESHAP standards into the State regulations, as they apply to both part 70 and non-part 70 sources.
The State also has the option of receiving partial delegation of a section 112 requirement, and the option to cancel the delegation of authority to implement and enforce previously adopted requirements. Automatic partial delegation of severable portions of any standard requires that the state: (1) Clearly define the separable subcategory in the particular standard, or the specific separable subset of affected sources in the specific standard so that regulated sources and the public know who is the implementing and enforcing authority; and (2) the applicable portions of the federal standard must be adopted by IBR into the state regulations or rules with an additional, clear explanation of what
The EPA proposes to approve North Dakota's program for receiving delegated authority to implement and enforce emissions standards and other requirements for air pollutants subject to section 112 of the CAA as recodified by the State. The EPA also proposes approval of revisions to the section 112 automatic delegation arrangement between the EPA and the State of North Dakota to accommodate the transfer of environmental regulatory programs from the NDDH to the NDDEQ. The proposed approval of recodification of federal NESHAP and MACT requirements and legal authorities to implement and enforce section 112 requirements, and the recognition of the NDDEQ's ability to receive delegated federal authority to administer the State's section 112 program will affect the transfer from the NDDH to the NDDEQ of the authority to implement and enforce all incorporated, unchanged federal NESHAP and MACT requirements.
Section 111 of the CAA authorizes the EPA to establish a list of source categories which contribute significantly to air pollution and authorizes the Agency to publish regulations establishing federal performance standards for new sources within such categories. Section 111 performance standards for new sources are categorically referred to as NSPS and may individually be found in 40 CFR part 60.
Section 111(c) of the Act establishes that the EPA may find a state program as “adequate” for purposes of implementing and enforcing the NSPS and delegate these authorities to the state. Delegation of authority confers upon the state primary implementation and enforcement responsibility; however, the EPA also retains concurrent authority to enforce the standards, and sole authority over those portions of the standards that may not be delegated. The usual method for establishing adequacy of a state's program is to verify both the existence of an approved state title V permitting program and that the part 60 federal NSPS requirements are IBR in the state's code. If these two program features can be positively verified, the state is considered capable of implementing and enforcing the section 111 standards and the state may request delegation of authority to administer the NSPS requirements for sources within the state. After section 111 program approval, a state and the EPA may reach an agreement to “automatically” delegate future NSPS requirements to the state, if the future requirements are IBR in the state's code. Automatic delegation arrangements allow the state to administer the NSPS as they are updated or introduced without need for case-by-case approvals from the EPA. North Dakota and the EPA currently maintain such an arrangement.
The EPA last affirmed delegation of NSPS to North Dakota in a letter dated February 27, 2014,
As North Dakota is seeking approval of the transfer of its title V program to the NDDEQ concurrent with the State's revisions to its section 111 program, the EPA requested that the State demonstrate the adequacy of its program and resources for implementing and enforcing NSPS requirements independent of a fully approved operating permits program. The EPA evaluated the State's section 111 program based on the minimum program elements recommended in the Agency's 1983 “Good Practices Manual for Delegation of NSPS and NESHAPs.”
The EPA reviewed North Dakota's section 111 program adequacy demonstration with reference to the “Good Practices” manual for NSPS delegations. The requirements of emission limits and test methods consistent with federal regulations, as well as the requirement of adequate source reporting and monitoring requirements, have been met with the IBR of federal NSPS requirements in the State air pollution control rules. The State updated all IBR citations as necessary. The EPA reviewed the State's incorporations and finds them substantively equivalent to incorporations as they existed at the time of the 2014 approval of NSPS delegation of authority to the State during the NDDH's administration of North Dakota's environmental regulations.
North Dakota's request included NSPS in 40 CFR part 60 as they existed through July 1, 2015.
The NDDEQ would maintain primary responsibility for the enforcement of the delegated section 111 standards within the State. If the NDDEQ determines that such enforcement is not feasible and so notifies the EPA, or on the occasion of the NDDEQ acting in a manner incongruous with the terms of this delegation arrangement, the EPA may exercise its parallel enforcement authority pursuant section 113 of the CAA with respect to sources within North Dakota subject to the section 111 new source performance standards.
There are some section 111 standards that may not be delegated to a state and which are not included in this automatic delegation arrangement. The emission guidelines (EG) found in 40 CFR part 60, subparts Cb, Cc, Cd, Ce, Cf, BBBB, DDDD, FFFF, and MMMM require states to develop implementation plans for `existing' facilities of certain source categories, which are then approved under a separate process pursuant to section 111(d) of the CAA.
In addition, some portions of the section 111 standards and the associated general provisions of part 60, by their own terms, may not be delegated to a state. The EPA Administrator retains authority to implement those sanctions that require: (1) Approving equivalency determinations and alternate test methods; (2) decision making to ensure national consistency; and (3) EPA rulemaking in order to implement. 40 CFR 60.4(d) also contains certain NSPS authorities that are not delegated to state and local agencies. Additionally, the document titled “INSERT” in the docket for this proposal contains a list of example sections in 40 CFR part 60 that may not be delegated to a state. Accordingly, EPA retains authority over those portions of the CFR part 60 standards that may not be delegated.
If this delegation is finalized, all questions concerning implementation and enforcement of the excluded standards in the State of North Dakota should be directed to the EPA Region 8 Office.
If this NSPS delegation is finalized, the State will obtain concurrence from the EPA on any matter involving the interpretation of section 111 of the CAA or 40 CFR part 60 to the extent that implementation or enforcement of these provisions have not been covered by prior EPA determinations or guidance.
We retain the right, as provided by CAA section 111(c)(2), to enforce any applicable emission standard or requirement under section 111. We also retain any authority in an individual standard that may not be delegated according to provisions of the standard and retain the authorities stated in the preceding delegation agreement.
The State must provide any information identified in the Performance Partnership Agreement to the EPA, in accordance with the terms of the Agreement.
The EPA oversees the State's decisions to ensure the delegated authorities are being adequately implemented and enforced. We will integrate oversight of the delegated authorities into the existing mechanisms and resources for oversight currently in place. We will initiate withdrawal of the program or rule if the corrective actions taken are insufficient.
For the delegated NSPS standards and authorities covered by this proposed action, if finalized, sources would submit all of the information required pursuant to the general provisions and the relevant subparts of the delegated NSPS (40 CFR part 60) directly to the State. The State is the primary point of contact with respect to delegated NSPS. Sources do not need to send a copy to the EPA. For those standards and authorities not delegated as discussed above, sources must continue to submit all appropriate information to the EPA.
As stated in previous NSPS delegation actions, the EPA has approved North Dakota's mechanism of incorporation by reference of NSPS standards into the State regulations, as they apply to both part 70 and non-part 70 sources.
The State also has the option of receiving partial delegation of a section 111 requirement, and the option to cancel the delegation of authority to
With this notice of proposed rulemaking, the EPA is providing public notice and opportunity for public comment on the Agency's intention to approve revisions to the State of North Dakota's section 111 program for implementation and enforcement of NSPS requirements. The agency is also proposing straight delegation of all applicable implementation and enforcement authorities necessary to regulate section 111 sources covered by the relevant subparts of 40 CFR part 60 incorporated unaltered into State code. This proposed delegation shall not be construed as extending to those part 60 subparts which cover existing sources that require EPA approval of a state plan that affects the implementation and enforcement of federal emissions guidelines for such source categories (section 111(d) sources); nor shall this proposed action be construed as delegating those authorities under section 111 of the Act and part 60 which are reserved by the Administrator of the EPA and not subject to delegation. The EPA is also proposing approval of revisions to the automatic delegation arrangement between the EPA and the State of North Dakota to accommodate the transfer of delegated NSPS implementation and enforcement from the NDDH to the NDDEQ.
All revisions to the title V operating permits program, and section 111 and 112 programs would be federally enforceable as of the effective date of the EPA's approval of the respective revision and recodification of those programs, with the exception of the EPA's grant of interim approval of the part 70 program. The State plans to rely on the date when the EPA signs the final notice for purposes of notifying the state legislature that the EPA has approved these revisions, which will provide for the transfer authority from NDDH to NDDEQ to be effective under State law. Prior to the effective date of this approval, the State intends to take the necessary additional steps as specified in S.L. 2017, ch. 199, Section 1, to ensure that NDDEQ rules and the NDDEQ would become federally enforceable on the effective date of the EPA's approval. Unless and until the NDDEQ rules and agency become fully effective under federal law, for purposes of federal law the EPA recognizes the State's program as currently approved under the North Dakota Department of Health.
Under the CAA, the Administrator is required to approve:
• A state permit program submittal that complies with the provisions of the Act and applicable federal regulations. 42 U.S.C. 7661a(d); 40 CFR 70.1(c), 70.4(i). Thus, in reviewing permit program submittals, the EPA's role is to approve state choices, provided they meet the criteria of the CAA and the criteria, standards and procedures defined in 40 CFR part 70;
• A state program for receiving delegated authority to implement and enforce emission standards and other requirements for air pollutants subject to section 112 if such program complies with the provisions of the Act and applicable federal regulations. 42 U.S.C. 7412(l); 40 CFR part 63, subpart E. Thus, in reviewing section 112 program submittals, the EPA's role is to approve state choices, provided they meet the criteria of the CAA and the criteria, standards and procedures defined in 40 CFR parts 61 and 63; and
• A state program for receiving delegated authority to implement and enforce emission limitations for new stationary sources subject to section 111 if such program complies with the provisions of the Act and applicable federal regulations. 42 U.S.C 7411(c). Thus, in reviewing section 111 program submittals, the EPA's role is to approve state choices, provided they meet the criteria of the CAA and implement the requirements, standards and procedures defined in 40 CFR part 60.
Accordingly, this action merely proposes to approve state law as meeting federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:
• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because Operating Permits Program approvals are exempted under Executive Order 12866;
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and
• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, this action is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the proposed rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations,
42 U.S.C. 7401
Environmental Protection Agency (EPA).
Proposed rule; withdrawal.
The U.S. Environmental Protection Agency (EPA) is withdrawing its January 19, 2017, proposed rule addressing health and environmental protection standards under the Uranium Mill Tailings Radiation Control Act of 1978 (UMTRCA) that would have applied to byproduct materials produced by uranium in-situ recovery (ISR) and would have subsequently been implemented by the U.S. Nuclear Regulatory Commission and its Agreement States. The EPA is withdrawing the proposed rule for three reasons. First, the EPA, informed in part by feedback received on the proposal, has serious questions as to whether the proposed rule as written is within EPA's authority under UMTRCA. Second, the EPA no longer believes that a national rulemaking to promulgate standards is necessary at this time, as the EPA believes the existing regulatory structures are sufficient to ensure the targeted protection of public health and the environment at existing ISR facilities. Third, present market circumstances suggest that the influx of new ISR license applications that was once anticipated and that was an underlying motive for the proposal is not likely to materialize.
The proposed rule published on January 19, 2017 (82 FR 7400), entitled “Health and Environmental Protection Standards for Uranium and Thorium Mill Tailings,”, is withdrawn as of October 30, 2018.
Ingrid Rosencrantz, Office of Radiation and Indoor Air, Radiation Protection Division, Mail Code 6608T, U.S. Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone number: 202-343-9290; fax number: 202-343-2304; email address:
On January 19, 2017, the U.S. Environmental Protection Agency (EPA) proposed new health and environmental protection standards under the Uranium Mill Tailings Radiation Control Act of 1978 (UMTRCA) (2017 Proposal).
The EPA has decided to withdraw the 2017 Proposal for three reasons. First, stakeholders, including the NRC, raised significant concerns regarding the EPA's legal authority under UMTRCA to propose these standards. Based on those significant concerns, we now have serious questions concerning whether the EPA has the legal authority under UMTRCA to issue the regulations as developed in the 2017 Proposal.
Second, the EPA no longer believes that a national rulemaking to promulgate standards is currently necessary as the Agency believes the existing regulatory structures are sufficient to ensure the targeted protection of public health and the environment at existing ISR facilities. The NRC stated in its public comments that its “current regulations, at 10 CFR part 40, Appendix A, and those of the various Agreement States, as supplemented by site-specific license conditions, guidance documents . . . and the operational experience and technical expertise of the regulatory agency staff,
Third, present market circumstances suggest that the influx of new ISR license applications that was once anticipated, and that was motivation for the proposal, is not likely to materialize. Therefore, there is less need for the rule, which was intended to provide a more workable and efficient approach for addressing these expected new applications, compared to existing mechanisms.
In the 2015 Proposal, the EPA explained that it was “proposing these new standards” under its authority in section 206 of UMTRCA which “authorizes EPA to promulgate general standards for the protection of public health, safety, and the environment from radiological and non-radiological hazards associated with . . . the processing and the possession, transfer, and disposal of byproduct material at sites at which ores are processed primarily for their uranium and thorium source material content or which are used for the disposal of such byproduct material.”
Most of the commenters' objections to the EPA's application of its authority under UMTRCA in the 2015 Proposal centered around the meaning of the phrase “standards of general application” in the statutory provision. Commenters opposing the proposed standards stated, “the proposed rules were legally invalid and felt the EPA was overreaching its authority under UMTRCA by proposing standards that are too detailed and prescriptive.”
In its response to the many comments opposing the EPA's proposed application of its authority, the EPA in the 2017 Proposal indicated that it “disagree[d] with those commenters who believe the EPA has redefined its role or overreached its authority in developing the new standards for ISR facilities.”
Several stakeholders, including the NRC, subsequently submitted comments on the 2017 Proposal, again stating that the proposed standards could not be reasonably classified as “generally applicable standards” under UMTRCA and thus was outside EPA's authority. In the 2017 Proposal, the EPA identified the proposed standards as falling into one of three different categories: (1) “Constituent concentration standards;” (2) “initial stability standards;” and (3) “long-term stability standards.”
Other commenters disputed the EPA's authority to adopt regulatory requirements that they alleged could not reasonably be considered “generally applicable standards.” For example, the Uranium Producers of America (UPA) argued that the proposed standards “exceed[s] EPA's jurisdictional authority as set forth by UMTRCA.”
Other stakeholders submitted comments in support of the 2017 Proposal, reiterating their position that they believe the EPA has the authority to propose these types of “generally applicable standards” under UMTRCA.
Based on the discussion above, EPA now has serious questions concerning whether we have the legal authority to issue the regulations as proposed in the 2017 Proposal. In conjunction with the grounds for withdrawal discussed below, this uncertainty as to our authority weighs in favor of withdrawing the 2017 Proposal.
When EPA initiated this rulemaking, there was already an effective system in place providing environmental oversight of ISR operations. As we explained in the 2015 Proposal, “in 1983, EPA originally promulgated regulations at 40 CFR part 192, Health and Environmental Protection Standards for Uranium and Thorium Mill Tailings, in response to the statutory requirements of the Atomic Energy Act [AEA] of 1954, as amended by the Uranium Mill Tailings Radiation Control Act of 1978 (UMTRCA).”
In the 2015 Proposal, under the heading “Why does EPA believe new standards are necessary?” the Agency stated: “We believe that ISR-specific standards are necessary because uranium ISR operations are very different from conventional uranium mills and the existing standards do not adequately address their unique aspects. In particular, we believe it is necessary to take a longer view of groundwater protection than has been typical of current ISR industry practices. Although the presence of significant uranium deposits typically diminishes groundwater quality, current industry practices for restoration and monitoring of the affected aquifer may not be adequate to prevent either the further degradation of water quality or the more widespread contamination of groundwater that is suitable for human consumption.”
In response to both proposals, the EPA has received numerous comments questioning the need or benefits of the rule. For example, in the 2017 Proposal the EPA noted that “Industry commenters and others say that there is no need for this rule because the EPA has not identified an instance in which an ISR operation has contaminated a source of drinking water.”
In addition to the public stakeholder comments mentioned above, most importantly, the NRC, the agency tasked with implementing the program, weighed in on the debate, stating in its public comments that “the NRC staff has concluded that its application of the 10 CFR part 40, Appendix A regulations to ISR facilities meets the AEA standard of `adequate protection' of public health and safety and the environment. . . .”
In considering these factors, as well as the presence of an existing program that the NRC (the implementing agency) believes is sufficient, and the lack of expected growth and status of the industry as described further in the next section of this withdrawal action, the EPA believes that the reasonably envisioned public health and environmental benefits of the proposed rulemaking are limited and do not warrant EPA proceeding with its proposed rulemaking. The existing regulatory structures, adequately address the current environmental concerns.
Finally, the EPA believes that market forces themselves have lessened the need for such a rule. Initially, several factors, including the expected growth in this industry, led the EPA and the NRC to believe that regulation of ISR activities could be more workable and efficient if the EPA issued standards of general application specific to the ISR facilities that the NRC would incorporate into its own regulations and implement through its licensing activities.
The NRC is currently reviewing license applications for only three expansions of ISR facilities and, for the next five years, the NRC expects only one license application for an expansion of one ISR facility and one license application for one new ISR facility.
The proposal of generally applicable national standards by EPA was driven partly by the expectation of a significant number of new facilities (which would have also applied to operating wellfields at existing facilities), making these proposed ISR-specific standards a more immediate prerequisite to achieving the efficiency across all regulatory programs that the NRC acknowledged could be gained by a “regulatory regime . . . specific to ISRs.”
Given this change in circumstances, completion of this rule is no longer expected to achieve the regulatory efficiency that was sought when this rulemaking effort began. The NRC and the NRC Agreement States currently regulate, through existing licenses, the limited number of operating ISR facilities and such an approach has been workable in practice for this number of
In addition, we find support for our decision to withdraw the proposed rule in the NRC's comments on the 2017 Proposal. As explained above, the EPA developed the proposed standards partly based on its understanding, after consultation with the NRC, that the anticipated growth in the number of ISR facilities highlighted a need for standards specific to ISR facilities, rather than continuing to apply standards that were originally written to address surface disposal of uranium mill tailings.
The NRC's current regulations, at 10 CFR part 40, Appendix A, and those of the various Agreement States, as supplemented by site-specific license conditions, guidance documents (
Considering the prevailing economic conditions affecting current and projected production, which leads the NRC now to expect significantly fewer future license applications, as opposed to the large increase that it expected at the time the rulemaking process was initiated (which was motivation for the proposal), we conclude that withdrawing this proposal is appropriate.
The statutory authority for this notice is provided by section 275 of the Atomic Energy Act (AEA), as added by section 206 of UMTRCA (42 U.S.C. 2022) and the Administrative Procedure Act (APA) (5 U.S.C. 551
Because the EPA is not promulgating any regulatory requirements, there are no compliance costs or impacts associated with today's final action.
Today's action does not establish new regulatory requirements. Hence, the requirements of other regulatory statutes and Executive Orders that generally apply to rulemakings (
Centers for Medicare & Medicaid Services (CMS), HHS.
Advance notice of proposed rulemaking with comment.
We are issuing this advance notice of proposed rulemaking (ANPRM) to solicit public comments on potential options we may consider for testing changes to payment for certain separately payable Part B drugs and biologicals (hereafter called “drugs”). Specifically, CMS intends to test whether phasing down the Medicare payment amount for selected Part B drugs to more closely align with international prices; allowing private-sector vendors to negotiate prices for drugs, take title to drugs, and compete for physician and hospital business; and changing the 4.3 percent (post-sequester) drug add-on payment in the model to reflect 6 percent of historical drug costs translated into a set payment amount, would lead to higher quality of care for beneficiaries and reduced expenditures to the Medicare program.
To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on December 31, 2018.
In commenting, please refer to file code CMS-5528-ANPRM. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.
Comments, including mass comment submissions, must be submitted in one of the following three ways (please choose only one of the ways listed):
1.
2.
Please allow sufficient time for mailed comments to be received before the close of the comment period.
3.
For information on viewing public comments, see the beginning of the
Hillary Cavanagh, 410-786-6574 or the IPI Model Team at
Comments received timely will also be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, phone 1-800-743-3951.
The Medicare program and its beneficiaries currently pay more for many high-cost drugs than many other countries.
The IPI Model aims to drive better quality for Medicare beneficiaries and reduce Medicare drug spending by offering comparable pricing relative to other countries and addressing flawed incentives in the current payment system. Currently, Medicare pays substantially more than other countries for the highest-cost physician administered drugs.
We are proposing to design the IPI Model to achieve the following: (1) Reduce expenditures while preserving or enhancing the quality of care for beneficiaries; (2) ensure the United States (U.S.) is paying comparable prices for Part B drugs relative to other countries by phasing in reduced Medicare payment for selected drugs based on a composite of international prices; (3) reduce out-of-pocket costs for included drugs for Medicare beneficiaries, and thereby increase access and adherence due to decreased drug costs; (4) maintain relative stability in provider revenue through an alternative drug add-on payment for furnishing drugs that removes the current percentage-based drug add-on payments, which creates incentives for higher list prices and to prescribe higher cost drugs; (5) reduce participating health care providers' burden and financial risk associated with furnishing included drugs by using private-sector vendors to purchase and take title to included drugs; and (6) introduce greater competition into the acquisition process for separately payable Part B drugs.
In section III. of this ANPRM, we discuss the model concept design for the IPI Model. This IPI Model would focus on selected separately payable Part B drugs and biologicals (hereafter called “drugs”). Specifically, the IPI Model would initially focus on Part B single source drugs, biologicals, and biosimilars that encompass a high percentage of Part B drug utilization and spending. The Innovation Center would test this model under section 1115A of the Social Security Act (the Act), which authorizes testing models expected to reduce program expenditures, while preserving or enhancing the quality of care furnished to beneficiaries. The model under consideration would include physicians, hospitals, and potentially other providers and suppliers in selected geographic areas. The IPI Model test would include the following components:
• Set the Medicare payment amount for selected Part B drugs to be phased down to more closely align with international prices;
• Allow private-sector vendors to negotiate prices for drugs, take title to drugs, and compete for physician and hospital business; and
• Increase the drug add-on payment in the model to reflect 6 percent of historical drug costs.
• Pay physicians and hospitals the add-on based on a set payment amount structure; CMS would calculate what CMS would have paid in the absence of the model, before sequestration, and redistribute this amount to model participants based on a set payment amount.
These and other components of the potential model are described in greater detail in this ANPRM.
We are considering issuing a proposed rule in the Spring of 2019 with the potential model to start in Spring 2020. The potential model would operate for five years, from Spring 2020 to Spring 2025. Of note, as discussed in section III.I. of this ANPRM, the IPI Model may have an impact on Medicaid drug rebates and payments, which we continue to explore.
With the release of this ANRPM, we solicit public input on our intended model design to inform our ongoing work to develop the IPI Model.
In the U.S., Part B drugs that are administered in the outpatient setting usually flow from the manufacturer through drug wholesalers (or specialty distributors) to the provider or supplier. At each step of the process, the drugs are sold to the next entity in the supply chain and that entity takes title to the drug. Distribution management systems are employed to order drugs, track sales and shipments, manage price and customer lists, record financial transactions, and support other industry processes. Figure 1 provides a high-level
The role of the health care provider within the buy-and-bill system is to seek out low cost drug suppliers and purchasing mechanisms (for example, by joining a group purchasing organization (GPO)), order, buy (or use financing), receive, and store drugs, administer drugs to patients, file claims to bill insurers for payment, and collect patient cost-sharing. There are many different buying strategies that enable physicians and hospitals to obtain lower drug prices. These strategies include using GPOs, group purchasing arrangements, wholesaler/distributor price lists, the 340B Prime Vendor,
Physicians generally purchase Part B drugs from a wholesaler, distributor, or specialty pharmacy. Hospitals generally purchase for their outpatient departments through their hospital pharmacy's arrangement with a drug wholesaler. Physicians and hospitals also have arrangements with manufacturers, individually or through their GPOs, for discounts that are tied to prescribing, for example volume discounts based on purchases of drugs for all patients that are treated. Drug wholesalers, distributors, and specialty pharmacies negotiate with manufacturers on the price they will pay to acquire drugs. When applicable, contract pricing controls the price that the health care provider will pay to the wholesaler, distributor, or specialty pharmacy, while shipping and handling and other terms may vary. Through a process called the “chargeback process,” manufacturers reduce the final drug prices to wholesalers and other
Under the Medicare Prescription Drug, Improvement and Modernization Act of 2003, which established section 1847B of the Act, we have authority to implement the “Competitive Acquisition Program” or “CAP” for Part B drugs that are not paid on a cost or prospective payment basis. The CAP was implemented in the mid-2000s.
The CAP was an alternative to the average sales price (ASP) methodology that is used to pay for the majority of Part B drugs, particularly drugs that are administered during a physician's office visit. Instead of buying drugs for their offices, physicians who chose to participate in the CAP would place a patient-specific drug order with an approved CAP vendor; the vendor would provide the drug to the office and then bill Medicare and collect cost-sharing amounts from the patient. Drugs were supplied in unopened containers (not pharmacy-prepared individualized doses like syringes containing a patient's prescribed dose). When the CAP was in place, most Part B drugs used in participating physicians' offices were supplied by the approved CAP vendor. Unlike the buy and bill process that is still used to obtain many Part B drugs, physicians who participated in the CAP did not buy or take title to the drug. Physician participation in the CAP was voluntary, but physicians had to elect to participate in the CAP. CAP drug claims were processed by a designated carrier.
CMS conducted bidding for CAP vendors in 2005. The first CAP contract period ran from July 1, 2006 until December 31, 2008. One drug vendor participated in the program, providing drugs within approximately 180 Healthcare Common Procedure Coding System (HCPCS) billing codes (including heavily utilized drugs in Part B) to physicians across the United States and its territories. The parameters for the second round of the vendor contract were essentially the same as those for the first round. While CMS received several qualified bids for the subsequent contract period, shortly before the second contract period began, contractual issues with the successful bidders led to the postponement of the program, and the CAP has been suspended since January 1, 2009.
As described previously, the CAP operated for a brief time from 2006 to 2008. The Part B drug market has changed since that time. Higher cost drugs, particularly biologicals manufactured by sole sources, are driving increasing Part B drug expenditures.
Since 2009, physicians have faced growing financial risks under the buy and bill approach, as the prices of Part B drugs have increased. Hospitals have varying ability to negotiate discounts, so some hospitals face similar financial challenges for the outpatient drugs they provide. Further, the rising costs of prescription drugs in the Medicare Part B program strain federal resources as well as beneficiaries' wallets.
As envisioned, the CAP had the potential to reduce risk for enrolled physicians and Medicare expenditures. As implemented, the CAP was tied to the ASP payment under section 1847A of the Act and did not achieve savings.
Recently, we have heard from stakeholders, including physician and hospital groups, and beneficiary advocates, that a CAP-like approach with improvements, particularly in regards to onsite availability of drugs, could potentially address concerns about the financial burdens associated with furnishing Part B drugs and their rising costs, and address challenges experienced in the CAP. Stakeholder feedback on the CAP has been considered in the development of the potential IPI Model described in this ANPRM. In addition, comments received on a Request for Information on a potential model to leverage the authority under the CAP for Part B drugs and biologicals that was included in the Calendar Year 2019 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System proposed rule (83 FR 37046) and comments received on the HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (83 FR 22692) were considered.
Medicare Part B drug expenditures have increased significantly over time. From 2011 to 2016, Medicare FFS drug spending increased from $17.6 billion to $28 billion under Medicare Part B, representing a compound annual growth rate (CAGR) of 9.8 percent, with per capita spending increasing 54 percent, from $532 to $818.
Drug acquisition costs in the United States exceed those in Europe, Canada, and Japan, according to a Department of Health and Human Services (HHS) analysis
Among the 27 products included in the analysis, acquisition costs in the U.S. were 1.8 times higher than in comparator countries.
As a result, Medicare beneficiaries and the Medicare program are bearing unnecessary, potentially avoidable costs for Part B drugs.
The potential IPI Model would leverage and improve upon the CAP approach by paying physicians and hospitals for drug-related costs, providing more flexibility for drug ordering and distribution, and by having model vendors compete for business from physicians and hospitals. Through the potential IPI Model, we seek to test ways to remove physicians and hospitals outpatient departments from the buy and bill process, without creating undue disruption to the distribution system.
CMS is considering contracting with a number of private-sector vendors that would supply physicians, hospital outpatient departments, and other included providers and suppliers with the drugs and biologicals that CMS would include in the model in all of the model's selected geographic areas. Similar to the CAP, the model vendors, rather than the health care providers, would take on the financial risk of acquiring the drugs and billing Medicare. Instead of paying the model vendors based on bid amounts, as section 1847B of the Act prescribes for the CAP, under the IPI Model Medicare would pay the vendor for the included drugs based on international prices discussed in section III.D. of this ANPRM, which would be intended to lower the amount Medicare pays for included drugs and beneficiary cost-sharing. The model vendors would have flexibility to offer innovative delivery mechanisms to encourage physicians and hospitals to obtain drugs through the vendor's distribution arrangements, such as electronic ordering, frequent delivery, onsite stock replacement programs, and other technologies. Physicians and hospitals in the model test would select the vendors that best provide customer service and support beneficiary choice of treatments, and would be able to engage with multiple vendors for different drugs and to change vendors. In addition to the Medicare drug administration payment that would still be made to physicians and hospitals, the model would pay physicians and hospitals a “drug add-on amount” that would be different from the current drug add-on amount.
Outside of the designated model test areas and for drugs not included in the model, health care providers would continue to use the buy and bill approach and the current Medicare FFS payment policies would apply.
This ANPRM describes features of a potential model in more detail, such as how an international pricing index could be developed and tested. We intend to waive program requirements to the extent necessary to test the model design that we would implement through notice and comment rulemaking. We seek feedback on a number of potential model elements described in the following sections of this ANPRM. These include:
• What limitations would be in place on the entities that could participate as vendors (
• Which countries should be included in calculating an international pricing index? How frequently should international data be updated?
• What should be the schedule for phasing in the spending target?
• Should we introduce health care provider bonuses to incentivize reductions in cost or utilization relative to a benchmark?
As CMS develops the IPI Model, we seek to minimize disruption within the drug distribution system while increasing competition, lowering U.S. drug prices, and removing the incentive for higher list prices. Under the CAP, the CAP vendor had to acquire the CAP drug and ship the drug to the ordering physician after receiving a beneficiary-specific order. Under the IPI Model we are considering, vendors would have the flexibility to offer a variety of delivery options, including beneficiary-specific prescriptions, pre-ordering approaches such as onsite inventory management solutions, and other arrangements that would not require physicians and hospitals to purchase the drugs or face greater buying costs. Physicians and hospitals would select the vendors that offer delivery mechanisms that best meet their patient care needs, practice size and location(s), and support needs. Agreements between the vendors and physicians/hospitals would establish the terms of their arrangements and would include appropriate guardrails to protect all parties, including beneficiaries and the Medicare program. CMS seeks feedback on whether CMS should be a party to and/or regulate these agreements, and whether the agreements should specify obligations to ensure the physical safety and integrity of the included drugs until they are administered to an included beneficiary, how drug disposition would be handled, and data sharing methods, confidentiality requirements, and potentially other requirements.
Under the potential IPI Model, we would intend to allow greater flexibility than under the CAP in the types of entities that could be selected as a model vendor (in accordance with applicable laws), and to minimize the impacts on drug distribution processes. Under the CAP, specialty pharmacies were the only entities that met the CAP vendor criteria, and only one such vendor participated in the program. To increase competition, the IPI Model would potentially allow entities such as GPOs, wholesalers, distributors, specialty pharmacies, individual or groups of physicians and hospitals, manufacturers, Part D sponsors, and/or other entities to perform the role of
We would require that model vendors purchase and take title to the included drugs, but to allow for innovative distribution approaches, model vendors would not be required to take physical possession of the drugs. For example, if a manufacturer establishes a limited distribution program, model vendors could negotiate with the manufacturer ways to purchase the drug while the established limited distribution entity would continue to ship the drug to the physician or hospital for administration.
We would expect that all model vendors would operate on a national basis; that is, model vendors potentially would be required to serve all of the selected model geographic areas and supply all included drugs to the physicians and hospitals that enroll with the vendor. The model would promote competition among multiple national vendors; vendors would compete for agreements with physicians and hospitals and other health care providers that would be included in the model. Physicians and hospitals would not be required to use only one vendor; we would encourage model participants to obtain drugs from the most cost effective model vendors. Enrolling with more than one vendor would allow physicians and hospitals more options for obtaining drugs timely, although the minimum requirement would be that model participants maintain enrollment with at least one vendor in order to furnish included drugs to the beneficiaries they serve timely.
Model vendors would operate enrollment for physicians and hospitals and would send periodic enrollment reports and other documentation to CMS to support model operations. In addition, model vendors would be prohibited from paying rebates or volume-based incentive payments to physicians and hospitals.
The model vendors' responsibilities would be based on the responsibilities of the CAP contractor under section 1847B of the Act and would be specified in a model vendor agreement. The model vendors would be responsible for such activities as—
• Negotiating with manufacturers for the vendor's drug acquisition prices for included drugs;
• Establishing mechanisms for the model vendor to take title to, but not necessarily physical possession of, included drugs, and arranging for the distribution of included drugs to participant health care providers for administration to included beneficiaries;
• Establishing mechanisms within the vendor's arrangements with manufacturers, physicians, hospitals, and other included providers and suppliers to receive compensation for vendor services;
• Implementing processes for participant health care providers to enroll with the vendor and to obtain included drugs;
• Meeting applicable licensure requirements in each State in which the vendor would supply included drugs and be enrolled in Medicare as a participating supplier, unless the model vendor distributes included drugs under contract with one or more entities, in which case the vendor must require that such entities meet applicable licensure requirements and be enrolled in Medicare as a participating supplier;
• Establishing mechanisms for physicians and hospitals to notify the vendor of the disposition of an included drug;
• Submitting claims for included drugs in accordance to model billing instructions established by CMS;
• Paying manufacturers for included drugs that were administered;
• Operating vendor-administered payment arrangements, such as indication based pricing, or outcomes-based agreements;
• Developing and implementing program integrity safeguards to ensure that all model requirements and applicable Medicare requirements are followed;
• Participating in model activities, including monitoring and evaluation activities;
• Providing support and technical assistance to participant health care providers; and
• Performing other functions and requirements as specified in the model vendor agreement, such as administrative requirements.
Physicians and hospitals would pay the model vendor for distribution costs and would collect beneficiary cost-sharing, including billing supplemental insurers.
In addition, similar to how the CAP operated, under the model, vendors would submit claims to Medicare and would be paid an applicable amount for the Part B drug that was administered to an included beneficiary. The model payment amounts to vendors for included drugs would be updated quarterly. The payment amount is described in section III.D. of this ANPRM. Unlike the CAP, under the potential model CMS would not solicit bid amounts for drugs. To the extent it would be legally allowable, vendors' agreements with physicians and hospitals could include provisions for delivery fees and other vendor costs.
On a periodic basis, for example quarterly, CMS would ensure that payment to the model vendors for administered drugs is substantiated by the physician and hospital submitted claims.
We seek feedback on other options for model vendor payment, including whether payment should include an administration fee from CMS and whether vendors' agreements with physicians and hospitals could include provisions for delivery fees and other vendor costs.
We are considering whether, given the flexibilities that model vendors and physicians and hospitals would have under the model, the model should include dispute resolution support, and if so, what such support should include.
We intend to operate a competitive selection process to identify the model vendors that would participate in the IPI Model. As we solicit applications for potential model vendors, we would encourage a variety of qualified entities to apply, including new business arrangements that could fulfill the vendor role on a national basis. We intend to select three or more model vendors so that physicians and hospitals have a number of vendors from which to obtain drugs and so that model vendors compete on the basis of
The model vendor solicitation would also specify the selection factors, which may include: The ability to negotiate with manufacturers; the ability to ensure product integrity; The ability to establish a customer service/grievance process; financial performance and solvency; record of integrity and the implementation of internal integrity measures; internal financial controls; maintenance of appropriate licensure to purchase drugs and biologicals; and ability to meet the model vendor agreement requirements within 6 months.
We would refuse to establish a model vendor agreement with an entity for reasons including—
• Exclusion of the entity under section 1128 of the Act from participation in Medicare or other Federal health care programs; or
• Past or present violations or misconduct related to the pricing, marketing, distribution, or handling of drugs covered under the Medicare program.
We would similarly include reasons to terminate a model vendor in the model vendor agreement. In addition, to ensure that selected model vendors would be able to perform their responsibilities under the model vendor agreement without influence from parties that have a financial interest related to included drugs or participating health care providers, we are considering including conflict of interest requirements similar to those established for the CAP in 42 CFR 414.912.
We are inviting public comment on the factors that would be necessary to allow CMS to identify entities that would most likely perform the responsibilities of a model vendor efficiently and effectively with minimal start up time.
• We seek information about the types of entities that could serve as national vendors for the model. Should CMS require model vendors to enroll any included health care provider? If included physicians and hospitals could be model vendors, should they be required to be a vendor for other health care providers, and should they have to operate on a national basis? Should any vendor be required to provide services on a national basis?
• We are also interested in public comment on the potential guardrails that would be appropriate if manufacturers and/or health care providers could serve as model vendors. Also should CMS receive shared savings based on the difference between a model vendor's negotiated price and CMS' payment amount? If so, how would CMS operationalize this shared savings approach?
• What should be the potential responsibilities of model vendors and model participants (included physicians, hospitals, and potentially other providers and suppliers) under the model. Specifically, are there ways that vendors and model participants could collaborate to enhance quality and reduce costs?
• What would be the ability of the potential types of entities that could be model vendors to negotiate for drug prices that would be at or below the IPI Model payment? Would certain types of entities have advantages or face additional challenges?
• Are there processes that model vendors could use to increase their price negotiation leverage with manufacturers and lower their potential loss exposure without increasing burdens on beneficiaries, physicians, and hospitals?
• Are there unsurmountable challenges related to physicians and hospitals paying for distribution costs and to continue to collect beneficiary cost-sharing, including billing supplemental insurers?
• Should physicians and hospitals receive bad debt payments if beneficiaries fail to satisfy cost-sharing obligations?
• Is there a need for the model to include billing and dispute resolution support, and if so, what should such support include?
• Should CMS pay the model vendors or should providers pay the model vendors for the responsibilities associated with taking title to drugs and distributing drugs? What incentives are established if CMS pays the model vendors?
• What should be the reasons for excluding entities from serving as a model vendor or terminating a model vendor agreement, as well as appropriate conflict of interest requirements?
• Should the role for the model vendors include entering into value-based payment arrangements (for example, indication-based pricing or outcomes-based agreements)? And if so, should there be requirements around these arrangements?
IPI Model participants would include all physician practices and hospital outpatient departments (HOPDs) that furnish the model's included drugs in the selected model geographic areas. CMS is considering whether to also include durable medical equipment (DME) suppliers, Ambulatory Surgical Centers (ASCs), or other Part B providers and suppliers that furnish the included drugs. Model participation would be mandatory for the physician practices, HOPDs, and potentially other providers and suppliers, in each of the selected geographic areas.
We intend to provide a more comprehensive list of health care providers included under the model if a proposed rulemaking moves forward.
For purposes of the potential IPI Model, beneficiaries would be included in the model if they are furnished any of the included drugs by a model participant in one of the selected geographic areas. More specifically, the following beneficiary eligibility criteria would be used based on the date that the included drug was furnished—
• The beneficiary is enrolled in Medicare Part B;
• The beneficiary is not enrolled in any group health plan or United Mine Workers of America health plan;
• Medicare FFS is the primary payer.
Medicare FFS beneficiaries who are not eligible for inclusion in the model would continue to receive drugs that were obtained by their health care provider using the buy and bill approach.
Under the IPI Model, model participants in the selected geographic areas would have to enroll with at least one model vendor and obtain included drugs from a model vendor for administration to included Medicare FFS beneficiaries. Model participants would have to follow model-specific billing instructions to submit informational drug claims and the model add-on payment. To reduce beneficiary impact, model participants would continue to collect beneficiary cost-sharing. We are considering ways to ensure the reconciling of beneficiary cost-sharing that model participants
The model would require the participation of physician practices and HOPDs (and potentially other providers and suppliers) in selected geographic areas across the U.S. and its territories, which would allow the Innovation Center to gain experience and insight into using an alternative payment methodology for drugs included in the model. We anticipate the selected geographic areas would include 50 percent of Medicare Part B spending on separately payable Part B drugs. The mandatory participation of physician practices and HOPDs (and potentially other health care providers that furnish included drugs) in the selected geographic areas would avoid having expected financial performance in the model influence the physician practice/HOPD's decision to participate or not. It also would ensure we capture the experiences of various types of physician practices and HOPDs in different geographic areas with varying characteristics and historic utilization patterns.
For the IPI Model, we are considering a randomized design with the randomization to intervention and comparison groups occurring at the geographic unit of analysis. There are two main factors that need to be considered when selecting geographies for the model: (1) The most appropriate geographic unit (ZIP code, county, core based statistical area, state, etc.) that reflects how care is delivered in markets, and (2) the geographic scope of the model, or the number of geographic units needed to generate statistically credible findings. Typically, the more geographic units available for random assignment to the model's intervention and comparison groups the better.
However, there is a tradeoff between the size of the geographic unit and the number of units available for assignment. We are considering using CBSAs (Core Based Statistical Areas) as the primary unit of analysis in the model. CMS is further considering whether it would be necessary to use larger geographic units such as aggregations of CBSAs (metropolitan statistical areas or combined statistical areas) to avoid the potential for routine shifts in the site of care to a practice location with a different assignment under the model. Geographic areas located outside CBSAs would not be included in the randomization to intervention or comparison groups. Health care providers outside of the randomized geographies could potentially have the opportunity to opt into the model. However, health care providers that are not part of the randomized treatment and control groups, but that opt into the model, would not be included in the evaluation sample.
Medicare Part B covers drugs administered by physicians in physician offices and hospital outpatient departments and certain drugs in other settings. In addition to payment for drug administration, Medicare Part B typically pays for separately payable Part B drugs at the average sales price (ASP) of a given drug, plus 6 percent of the ASP as an add-on (with sequestration, the actual payment allowance is ASP + 4.3 percent). This add-on payment can help to cover the costs of drug ordering, storage and handling borne by physicians and hospitals, payments to join group purchasing organizations (GPOs) or other entities with similar purchasing arrangements, as well as a portion of the drug costs themselves, in instances when the drug is acquired at a price more than ASP. However, the drug add-on payment may encourage increased utilization, particularly of higher-cost drugs, since doing so increases revenue for the physician or hospital when the add-on is higher than drug acquisition-related costs.
This section describes our thinking on alternative methods for making the drug add-on payment a set payment amount rather than as a percentage of ASP. We intend to structure the potential IPI model such that physicians and hospitals would be incentivized to seek out lower cost drugs for their beneficiaries, reduce inappropriate utilization, continue to pay for certain distribution costs, continue to bill Medicare for drug administration, albeit following model-specific instructions, and continue to collect beneficiary cost-sharing for included drugs. The goals for the model add-on payments would be to hold health care providers harmless to current revenue to the greatest extent possible; create an incentive to encourage appropriate drug utilization; remove the incentive to prescribe higher-cost drugs; and create incentives to prescribe lower-cost drugs in order to reduce beneficiary cost sharing. We have considered several different structures for the set payment amount.
CMS would base payment calculations for the alternative compensation on six percent (+6 percent) of the included Part B drugs' ASP, which would represent an increase from the +4.3 percent add-on that currently is paid due to sequestration, and would support appropriate drug utilization under the model structure. That is, in total the alternative compensation for model participants would approximate the expected add-on amount for included drugs in the absence of the model, before sequestration. Because the alternative compensation would not be paid in a manner that is tied directly to the ASP of an administered drug, there would not be an incentive for use of higher cost drugs when an alternative is available. As described in section III.D. of this ANPRM, Medicare payment for the drugs themselves would be to the model vendors; model participants would no longer “buy and bill” Medicare for included Part B drugs administered to included beneficiaries. Payment for drug administration services, when applicable, would continue to be separately billed by model participants to Medicare; there would be no change in the payment for drug administration services under the model. Beneficiary cost-sharing would apply to the model-specific alternative compensation payments and for model payments for included drugs.
Model participants would be paid a set payment amount per encounter or per month (based on beneficiary panel size) for an administered drug, which would not vary based on the model payment for the drug itself. We are considering whether to set a unique payment amount for each class of drugs, physician specialty, or physician practice (or hospital). That is, there would be a set payment amount per administered drug that would be based on—(1) which class of drugs the administered drug belongs to; (2) the physician's specialty; or (3) the physician's practice. If used, specialties would likely be defined broadly rather than at a subspecialty level (for example, ophthalmology rather than neuro-ophthalmology) given the difficulty of doing this through claims data, although CMS may identify an alternative approach. We would calculate the final payment amount, by drug class, physician specialty, or physician practice, annually based on
Total model payments to a model participant would vary based on utilization under an encounter-based model. To incentivize reduced utilization where appropriate, CMS is considering creating a bonus pool, where model participants would achieve bonus payments for prescribing lower-cost drugs or practicing evidence-based utilization. Importantly, as described in section III.F.3. of this ANPRM, we would monitor drug utilization carefully throughout the model to ensure beneficiary access to drugs is not compromised.
We welcome input from stakeholders on the potential approach for defining model participants, selecting geographic areas, and calculating an alternative to the ASP add-on for the IPI Model. Specifically, we would like to receive information on which alternative add-on option is preferable and how the specific payment methodology might be designed. For example:
• The exclusion of certain types of physician practices and/or HOPDs from the model. For example, should we consider excluding small physician practices/HOPDs (for example, those with 3 or fewer physicians) from the model or establish a low-volume threshold that would exclude those physician practices and HOPDs that fall below the threshold from participating in the model? How could CMS analyze an appropriate threshold?
• The inclusion of additional Part B providers and suppliers that furnish and bill for any of the model's included drugs as well as the inclusion of providers that are paid on a cost basis, such as PPS-exempt cancer hospitals, children's hospitals, or critical access hospitals.
• The potential approach to selecting geographic areas for the intervention and comparison groups in the model. Are there particular regions of the country that would need adjustments or exclusions from the model (for example, rural areas)?
• How should we operationalize the model for large provider networks that cover some regions that are included and some that are excluded?
• Should class of drugs, physician specialty, or physician practice determine the payment amount? Are there other characteristics that should determine the alternative add-on payment amount?
• How should a per month alternative add-on payment be determined? How and how often should a beneficiary panel size be determined?
• The potential inclusion of a bonus pool. Should a bonus pool be included in the model? If so, how should the model participant bonus pool be constructed to meet the goals of the model to incentivize the use of lower-cost drugs and clinically appropriate utilization? How could a bonus pool be constructed to best protect and enhance quality under the model? How should CMS handle variable low-volume estimates and missing data values when assessing performance for purposes of a bonus pool?
• The potential phase in of an alternate provider compensation. Should CMS phase in a change from percentage-based add-on payments to set payment amounts, or should set payment amounts be implemented in Year 1 of the potential IPI Model?
• How should CMS implement an administrative process to account for beneficiary cost-sharing for drugs that is collected by model participants?
The Part B drug benefit includes many types of drugs and encompasses a variety of care settings and payment methodologies. Of the approximately $28 billion per year of FFS Part B drug spending in 2016, about $23.6 billion or 84 percent, is for drugs administered incident to a physician's services. Among the “incident to” drugs, over 90 percent of spending is for single source drugs and biologicals (including biosimilars) as defined in section 1847A of the Act.
In Years 1 and 2 of the potential IPI Model, we would include single source drugs, biologicals, biosimilars, and multiple source drugs with a single manufacturer that we identify from what we believe are reliable sources of international pricing data, prior to direct data collection, as discussed in section III.D. of this ANPRM. In Years 3, 4 and 5, we would broaden the scope of included drugs to incorporate more of these single source drugs and biologicals as more sources of international pricing data become available, and we are considering further increasing the number of Part B drugs included in the model as discussed later in this section. We would begin with these two broad groups of drugs—single source drugs and biologicals—as they encompass most drugs used by most physician specialties that bill under Part B. At a minimum, we believe that we could begin the model by including most of the HCPCS codes that appear in the recent HHS report;
The OPPS packages certain drugs with costs below a certain threshold and for policy reasons. This model would only include drugs that are separately paid under the OPPS, including drugs on pass-through payment status, and for which the drug's HCPCS code is assigned a distinct Ambulatory Payment Classification (APC) group for use when the drug is furnished in a HOPD. The model would include any separately payable drug or biological furnished in an HOPD, including any of the HOPD's off-campus provider-based departments (PBDs), regardless of whether those PBDs are excepted or nonexcepted under section 1833(t)(21)(B)(ii) of the
For purposes of included drugs, we would remove any HCPCS codes that become inactive if they are not replaced by a successor code, and we would not include HCPCS codes for which a product becomes unavailable. If pricing data were available for other heavily utilized incident to drugs, we would consider adding them to the model. Over the course of the model, we seek to include HCPCS codes that encompass at least 75 percent of allowed charges in Part B. We note that HCPCS codes for products that are used across multiple settings, such as clotting factors or immunoglobulin G, would be included based on overall Part B use, but the model would only include those drugs when they are administered incident to a physician's service.
In addition, we are considering including multiple source drugs and drugs provided in other settings. Specifically, we are considering including multiple source drugs because we are concerned that price increases among generic drugs are also contributing to the rising payments for Part B drugs. Increasing the number of drugs included in the model over time could also be accomplished by setting; however, drug acquisition and billing within Part B settings outside of the physician office and outpatient hospital may not be conducive to a CAP vendor-like approach.
We are also considering the best ways to include newly approved and marketed drugs in the model. We anticipate that international pricing data for some but not all of these drugs would be available. We include a discussion of the potential alternatives for payments for new therapies in section III.D.5. of this ANPRM.
We anticipate that newly effective HCPCS codes could be added to the model on a quarterly or annual basis. Based on experiences with the CAP, we are concerned about issues such as the lag time resulting from the provider having to obtain drugs from regular channels before the drug is available from the vendor, the lead time for the development of vendors' acquisition arrangements, and the potential unavailability of pricing benchmarks for new drugs immediately after a drug is marketed.
Although we are not currently able to estimate exactly what the distribution of drugs over the course of the model may look like, Table 1 presents the percentage of the total allowed Part B charges for 2017 for Part B drugs. Table 1 lists the percentage of the total spending for the following two groups of HCPCS codes: The top 50 drugs by allowed charges in the office and hospital outpatient departments for 2017 and the top 100 such drugs. Spending for biologicals (including biosimilars), single source drugs, multiple source drugs and potentially excluded drugs within each of the three groups is also shown. We believe that this information is a reasonable preliminary estimate of the potential scope of this model and its possible incorporation of additional Part B drugs during the 5-year model duration.
The potential
We are considering excluding the following: drugs that are identified by the FDA to be in short supply (similar to the exclusion from the AMP price substitution policy for drugs in short supply (77 FR 69141)); and drugs paid under miscellaneous or “not otherwise classified” (NOC) codes, such as J3490, due to the operational complexity of identifying if drugs paid under the NOC codes are included model drugs. Thus, compounded drugs would be excluded from the model. We also plan to exclude radiopharmaceuticals and ESRD drugs paid under the authority in section 1881 of the Act. Finally, we also would exclude drugs that are packaged under the OPPS when they are furnished by a hospital outpatient department. If these drugs met other criteria, they would be included in the model when furnished by physician offices.
We are seeking information on the following:
• Whether the data that CMS uses to determine the inclusion of drugs and biologicals should be limited to claims from the physician's office and hospital outpatient department settings, or whether other settings should be included.
• The drugs to include in the model. Specifically, we are seeking information on how to incorporate multiple source drugs.
• Whether to include Part B drugs in all settings in which they are separately payable or only in certain settings.
• Whether quarterly updates for HCPCS codes included in the model are feasible. Feedback from the perspective of potential model participants and vendors are especially encouraged.
• The best way to include new drugs in the model as they become available.
• Whether to determine inclusion of drugs based on on-label (FDA approved) indications only, or whether CMS should consider on-label and off-label use (if supported by clinical guidelines and/or compendia).
We seek comment as to whether aspects of mandatory participation would require physicians and hospitals to have an agreement with a single vendor or would require physicians and hospitals to obtain all drugs included in the model via a single vendor.
The Medicare payment for separately payable Part B drugs is typically based on ASP of a given Part B drug, plus 6 percent of the ASP as an add-on payment. For the potential IPI Model,
The potential calculation steps would include the following:
• CMS would calculate an average international price for each Part B drug included in the model based on a standard unit that is comparable to that in the drug HCPCS code.
• CMS would then calculate the ratio of Medicare spending using ASP prices for all Part B Drugs included in the model to estimated spending using international prices for the same number and set of drugs. In order to do this calculation, CMS would multiply Part B volumes by the ASP prices and then by the international prices. The resulting ratio of Medicare spending under ASP versus Medicare spending under the international prices holding volume and mix of drugs constant would represent the International Price Index (IPI).
• CMS would also establish the model Target Price for each drug by multiplying the IPI by a factor that achieves the model goal of more closely aligning Medicare payment with international prices, which would be about a 30 percent reduction in Medicare spending for included Part B drugs over time, and then multiplying that revised index (IPI adjusted for spending reduction) by the international price for each included drug. CMS would calibrate the revised index to account for any drugs with ASP below the Target Price. The percentage reduction between ASP and Target Price would vary for each drug. We would monitor price changes and recalibrate as needed.
• CMS would phase-in the Target Price over the 5 years of the model, as a blend of ASP and the Target Price. For each calculation, if ASP is lower than the Target Price for an included drug, the model would set the payment amount to ASP for that drug.
The potential phase-in would use the following blend of ASP and Target Price:
• As with current Part B drug payments, we would plan to update the model payment amount for each drug periodically based on new ASP and international pricing data.
2. Data Sources on International Drug Sales
CMS is considering including collection of international drug sales data for purposes of the IPI Model. In the interim, before these data could be available, CMS is considering relying on existing data sources for calculating the model payment to model vendors for included drugs.
CMS has evaluated several existing data sources to determine the availability of international drug price information. Based on our review, we believe there are appropriate sources that could be used for purposes of the potential IPI Model. These data sets include those provided by private companies or data obtained through review of publicly filed materials by manufacturers in other countries. Examples may include IQVIA's MIDAS dataset, the dataset used in the recent HHS analysis.
We are considering including a data collection system for manufacturers to report to CMS their international drug sales data to support the calculation of the IPI and the Target Price for each drug. We acknowledge that manufacturers have numerous and varying arrangements in other countries as well as in the U.S., so we are considering how we would determine the definition of manufacturer to ensure that U.S. manufacturers would robustly report this information to CMS. Under the Medicaid Drug Rebate Program in section 1927 of the Act, manufacturers are required to provide information to CMS on a quarterly basis to support the ASP calculations (as well as to support calculations for WAC and AMP
We envision that we would require quarterly reporting on the international sales information and CMS would provide reporting instructions. The instructions would include information such as instructions for the unit level at which the manufacturer would report the sales information, which countries to include and how to account for the exchange rate, and use of reasonable assumptions. We anticipate that the units of measure for the international drug sales data would be the same as the units in a corresponding drug product's HCPCS code. For example, products reported in milligrams of drug in the U.S. would be reported in milligrams, and products reported in international units of biological activity would be reported in the same units of corresponding biological activity.
We acknowledge that this potential approach could create situations where very large numbers of units would be reported, and we seek information on alternative units of measure to consider. We recognize that it would take some time to establish the infrastructure and reporting instructions to collect and validate international sales information directly from manufacturers for purposes of a model. In light of this, we are considering whether existing data sources could be used to establish the IPI and Target Price in the short term and transition to using manufacturer reported data when available. We seek comment on the potential use of
We are considering examining the IPI and model payments on a quarterly basis, on the same schedule and using the same quarterly sales period duration as ASP data. We believe that we could use quarterly updates of existing data sources in the short term while we set up the infrastructure to collect and validate international drug sales information from the manufacturers on a quarterly basis (the data would be reported to CMS within 30 days of the close of the quarter). We seek comment on whether to examine the international pricing data, and recalculate the IPI and Target Prices on a quarterly, annual or other basis. We also seek feedback on the mechanism for reporting of international sales, and on any additional requirements that would be needed to ensure a feasible process to collect valid international sales information for the countries that would be included in the IPI, as discussed in the following section of this ANPRM. We also seek comment on ways to ensure confidentiality of reporting of international drug pricing to CMS.
We are considering using pricing data from the following countries: Austria, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Japan, Netherlands, and the United Kingdom.
We are considering including these countries as they are either economies comparable to the United States or they are included in Germany's market basket for reference pricing for their drug prices, and existing data sources contain pricing information for these countries. Some of the countries above have far lower per-capita incomes than the U.S. However, these countries were not consistently the lowest-priced countries according to the HHS analysis.
For newly approved and marketed Part B drugs that would be included in the model, there could be some time lag or other issues associated with capturing international sales information. In the absence of international pricing data, CMS could still calculate a model payment amount by applying a standard factor. CMS could, for example, assume the same ratio for the new drug as the IPI, which would be the average volume-weighted payment amount across all Part B drugs included in the model. We seek comment on options for calculating the model payment for new drugs that may not yet have international sales.
We welcome input from stakeholders on the potential approach for establishing model payments for included drugs based on international pricing. For example:
• What sources of international pricing data capture drug information for the international markets that should be included in our payment methodology?
• Are there particular data sources to establish payment amounts based on international pricing that would best support this effort?
• How should private market drug sales included in countries that provide drugs through public insurance be included? How should CMS protect manufacturer reported international pricing information?
• What is the appropriate frequency for updating the international pricing information that we use in calculating the Part B payment under the model?
• How should manufacturers report international pricing information? Are there specific issues with data reporting processes that stakeholders would like the agency to consider, especially mechanisms that could reduce burden?
• How should we define manufacturer to ensure that all relevant entities that sell single source drug products, biologics, biosimilars and, if applicable, multiple source drugs report under the model?
• Are there areas of concern in data collection and reporting that could lead to inaccurate price calculations?
• Which countries should be included in our international price index calculations? Should the countries vary? What characteristics should CMS consider to analyze these countries?
• Are there specific considerations in the comparison of international and ASP prices that CMS should address?
• How should CMS standardize data collection and reporting? What should be the target reduction to ASP payment (that is, Target Price), and what should be the schedule for phasing down to the target savings amount?
• How would such a change in payment policy, as described in this section, affect incentives in the market? How could using international reference pricing affect innovation incentives in the biopharmaceutical market?
Using international sales data in the potential IPI Model could raise considerations for drug prices, drug availability, and sales data in foreign markets. For example, manufacturers may seek to raise prices or limit foreign sales. However, existing, multiyear pricing relationships in foreign markets may minimize this response. There are also potential model implications in considering manufacturers' responses in foreign markets. For example, there may be a decrease or lack of international sales to serve as inputs to the model's IPI calculation, if manufacturers withdraw or do not launch included drugs in foreign markets. Similarly, manufacturers may also adjust their product launch strategies within the U.S.
Requests for feedback and information:
• CMS welcomes input from stakeholders on the potential considerations related to foreign markets and the potential model payment approach that would rely on international sales data. For example the following:
• What foreign market considerations should CMS consider in developing the potential IPI Model?
• How should CMS monitor for changes in foreign markets that could impact the IPI Model?
• What are ways to address changes in foreign sales that could impact model payment calculations?
In addition to existing beneficiary protections, we would plan to actively monitor the IPI Model test to ensure it is operating effectively and meeting the needs of beneficiaries, health care providers, and the Medicare program.
We would expect beneficiary cost-sharing for included drugs under the potential IPI Model would either be the same or lower than the non-model cost-sharing. Medicare payment policy for beneficiary cost-sharing would remain the same but since the IPI Model should reduce Medicare payment for some Part B drugs, the 20 percent beneficiary
To minimize impact on beneficiaries, their health care provider would continue to collect cost-sharing for included drugs.
We plan to coordinate with the Medicare Beneficiary Ombudsman to ensure that any Model-related beneficiary complaints, grievances, or requests for information submitted would be responded to in a timely manner.
Consistent with other Innovation Center Models, we would also implement a monitoring program for the IPI Model to ensure the model is meeting the needs of Medicare beneficiaries, health care providers and the Medicare program. These monitoring activities would enable CMS to access timely information about the effects of the Model on beneficiaries, providers, suppliers, and on the Medicare program and to facilitate real time identification and response to potential issues. We envision using Medicare claims and other available program data to analyze and monitor the Model's implementation, including actively looking at real-time data to identify potential impacts on beneficiaries, health care providers, model vendors, and the Medicare program. We would use these findings to inform Model oversight and the potential need for action to address findings.
As an example, CMS may conduct real-time analyses of claims and administrative data, such as monthly updates and historic comparisons of trends, including ensuring appropriate drug utilization and program spending, as well as changes in site-of-service delivery, mortality, hospital admissions, and other indicators present in claims and administrative data to identify any potential issues related to access and utilization. CMS would also consider how to best understand beneficiary experience in the model. We would consider surveys but would also be interested in other potential strategies to include beneficiary experience in our monitoring activities.
We are inviting public feedback on the appropriate beneficiary outcomes to monitor and how to monitor and measure such outcomes, as well as patient experience, in a way that minimizes burden on included health care providers and beneficiaries.
In designing each Innovation Center model, CMS considers potential overlap between a new model and other ongoing and potential models and programs. Based on the type of overlap, such as provider or beneficiary, operating rules are established for whether or not providers and beneficiaries can be part of both models as well as how to handle overlap when it is allowed to occur. These policies help to ensure that the evaluation of model impact is not compromised by issues of model overlap and that the calculation of Medicare savings is not overestimated due to double counting of beneficiaries and dollars across different models. In this vein, CMS has begun to review which models would have significant overlap with the potential IPI Model. One example is the Oncology Care Model (OCM) which runs through mid-2021. The OCM would require new policies that address model overlap due to the potential inclusion of some of OCM's initiating cancer therapies in the IPI Model and the probable overlap of some geographic areas with OCM practices included in the IPI Model. The IPI Model would potentially overlap with other Innovation Center models that operate in the same geographic areas and include Part B drug spending in the calculation of model payments, incentive payments or shared savings, and the Medicare Shared Savings Programs. We plan to carefully explore these potential overlaps and consider ways address overlap issues as we further develop the IPI Model.
With respect to single source or innovator multiple source drugs (which Medicaid recognizes to include biologicals and biosimilars), the term “Medicaid Best Price” is the lowest price available from the manufacturer during the rebate period to any wholesaler, retailer, provider, health maintenance organization, non-profit entity or governmental entity within the U.S. with certain exclusions. We seek comment on how to avoid unintended consequences on the interaction of the IPI Model with other federal programs.
Since the model payments to model vendors for drugs is a Medicare payment and it is not a “price available from the manufacturer,” the model payment amounts would not be included in the manufacturer's determination of best price. However, since the model payment amounts would drive manufacturer drug prices down, the model may impact a manufacturer's best price. In order for model vendors to purchase included drugs in the U.S. at prices that would not lead to financial loss, the prices available from the manufacturer would need to be competitive with the model payments. Therefore, such manufacturer sales to the model vendors could potentially lower best price and potentially increase Medicaid rebates. Medicaid programs could benefit.
Specifically, if the manufacturer lowers prices available to a model vendor at or below the model payment rate, such prices would be considered in the manufacturer's determination of best price and may reset the manufacturer's best price. This is particularly possible because the model payment amount includes the impact of sales outside of the U.S., which are typically lower than prices in the U.S., while a manufacturer's best price represents prices available only to purchasers in the U.S. We seek public comments on how manufacturers would respond to these factors as they relate to model vendors and Medicaid drug rebates.
Similarly, the model payment amounts to model vendors would not be part of the AMP determination. AMP is defined at section 1927(k)(1) of the Act. Generally, AMP is determined based on the average price paid to the manufacturer for a drug in the U.S. by wholesalers and retail community pharmacies with certain exclusions. The AMP for a Part B drug will likely be determined using the AMP computation for 5i drugs,
We continue to consider how the model may impact the Medicaid program. Authority for implementing innovative payment and quality models under 1115A of the Act does not completely include Title XIX waiver authority, and thus, such waiver authority does not extend to the Medicaid Drug Rebate Program, which is authorized under Title XIX at section 1927 of the Act. We welcome public feedback, including from State Medicaid programs, on this issue.
The Health Resources and Services Administration (HRSA) administers the 340B Drug Pricing Program that allows certain hospitals and other health care providers (“covered entities”) to obtain discounted prices on “covered outpatient drugs” (as defined at 1927(k)(2) of the Act) from drug manufacturers. HRSA calculates a 340B ceiling price for each covered outpatient drug, which represents the maximum price a manufacturer can charge a covered entity for the drug. Several types of hospitals as well as clinics that receive certain federal grants from the HHS may enroll in the 340B program as covered entities. Such entities located in the selected model geographic areas would be included in the IPI Model and would be supplied included drugs for included beneficiaries through a model vendor.
Covered entities that enroll in the 340B Program can purchase drugs at no more than a “ceiling price”, which are calculated based on a drug's AMP net the Medicaid unit rebate amount. Since the Medicaid unit rebate amount is based partly on AMP minus best price, to the extent the potential model affects a drug's AMP and best price, the 340B prices would be affected.
Congress created the Innovation Center for the purpose of testing innovative payment and service delivery models that are expected to reduce program expenditures while preserving or enhancing the quality of care for Medicare beneficiaries. In the IPI Model, we are considering collecting quality measures to help us better understand the impact of this model on beneficiary access and quality of care. We intend to identify quality measures to be collected as part of this model that reflect national priorities for quality improvement and patient-centered care consistent with the measures described in section 1890(b)(7)(B) of the Act, to the extent feasible. To this end, we are interested in several categories of measures, specifically: patient experience measures, medication management measures, medication adherence, and measures related to access and utilization.
We are sensitive to concerns regarding adding administrative burden to model participants. Some models (for example, the Bundled Payments for Care Improvement Advanced Model) are currently structured to include quality measures that are calculated directly by CMS or collected during the evaluation and do not require the submission of additional data by providers and suppliers. We are considering following this approach, to the extent feasible, and to assess the quality of care for purposes of real-time monitoring of utilization, hospitalization, mortality, shifts in site-of-service and other important indicators of patient access and outcomes, without requiring providers or suppliers to report additional data.
We seek information on the categories and types of quality measures CMS can incorporate in the model that are targeted and judicious, while still capturing key indicators of patient experience, access, and medication management. We welcome recommendations for specific measures.
We plan to test the potential IPI Model under the authority of section 1115A of the Act and to waive certain Medicare program requirements as necessary solely for purposes of testing the potential model. Under section 1115A(d)(1) of the Act, the Secretary of Health and Human Services may waive the requirements of Titles XI and XVIII and of sections 1902(a)(1), 1902(a)(13), 1903(m)(2)(A)(iii), and 1934 of the Act (other than subsections (b)(1)(A) and (c)(5) of such section) as may be necessary solely for purposes of carrying out section 1115A of the Act with respect to testing models described in section 1115A(b) of the Act.
We plan to waive requirements of the following provisions as may be necessary solely for purposes of testing the Model. The purpose of this flexibility would be to allow Medicare to test approaches described in the “Model Payment Methodology” section, with the goal of reducing Medicare expenditures while improving or maintaining the quality of beneficiaries' care as we implement and test this potential model.
• Section 1833(t) of the Act and 42 CFR 419.64 related to Medicare payment amounts for drugs and biologicals under the OPPS as necessary to permit testing of a modified payment amount for included drugs using the pricing approaches described in this section;
• Section 1847A of the Act and 42 CFR 414.904 and 414.802 related to use of ASP+6 percent and WAC as necessary to permit testing of a modified payment using the pricing approaches described in this paper.
• Section 1847B of the Act and 42 CFR 414.906 through 414.920 related to the Medicare Part B Drug Competitive Acquisition Program (CAP) requirements as necessary to permit testing using a CAP-like approach for the acquisition of included therapies through vendor-administered payment arrangements.
• Other requirements under title XVIII of the Act as may be necessary solely to test separate payment for included therapies furnished to included beneficiaries by participant health care providers not paid under the outpatient prospective payment system or section 1847A of the Act.
CMS may terminate the potential IPI Model for reasons including, but not limited to, the following: CMS determines that it no longer has the funds to support the Model; or CMS terminates the Model in accordance with section 1115A(b)(3)(B) of the Act.
Models operated under section 1115A of the Act are required to have an evaluation that must include an analysis of the quality of care furnished under the model and the changes in spending by reason of the model. The evaluation of the model would help inform the Secretary and policymakers whether this model, as designed, reduces program expenditures while maintaining or improving the quality of care furnished to Medicare beneficiaries.
Whenever feasible, a comparison group composed of entities similar to the model participants but not exposed to the model is used to determine the model impact. In this particular potential model, intervention and comparison groups would be determined through a random selection or assignment process. A randomized design helps minimize the impact of unmeasurable factors that may
We seek input on the evaluation approach to examine the IPI Model's impact on Medicare spending and quality of care including potential alternatives.
This section outlines the potential financial impact of implementing the potential IPI Model on federal Medicare and Medicaid spending. There are many uncertainties around estimating the financial effects of this model. In addition to the various policy parameters that are either currently unspecified or subject to change throughout the policy development process, the expected change in beneficiary, provider, vendor, and manufacturer behavior would significantly affect the financial impact of the model. The current analysis of this model reflects many generalized assumptions that are likely to change pending further policy development and additional analysis. As such, the estimates shown below should be considered an approximate measure of the potential savings of the potential model, and subsequent analyses would likely be materially different from those shown below as additional information becomes available.
The following table presents the potential financial impact of the model. For 2020-25, federal Medicare spending is estimated to be reduced by $16.3 billion and Medicaid spending for Medicare-Medicaid dual beneficiaries is expected to be reduced by $1.6 billion, of which $0.9 billion is reduced federal spending and $0.7 billion is reduced State spending.
Note the following:
• No changes in utilization are assumed in this analysis.
• Medicare Advantage spending would be reduced proportionately to the reduction in FFS spending.
• Included drugs would represent 61 percent of Part B allowed drug spending in years 1 and 2, 81 percent of Part B allowed drug spending in years 3 and 4, and 94 percent of allowed drug spending in year 5.
• The Medicaid impact represents the portion of Medicare cost-sharing that is paid on behalf of dual beneficiaries. It is estimated based on the change in Medicare cost-sharing and current dual beneficiary enrollment. No assumptions are made for State price limitations that would limit the beneficiary cost-sharing paid for by Medicaid.
• Effects on private market cannot be estimated at this time and are not reflected in this analysis.
Based on a review of the Part B drugs that constituted the majority of Part B drug spending in 2017, as well as the top reported Medicaid drugs that were also covered by Part B, the affected drugs reimbursed by Medicaid spending totaled at least $4 billion in 2017, or an estimated 6 percent of gross Medicaid drug spending. The model may impact AMP, ASP, best price, and 340B pricing for these affected drugs, reducing both reimbursements as well as rebates. CMS would seek comment on whether we should exempt prices offered under the model from AMP and Best Price calculations.
The potential IPI Model would affect a significant number of health care providers that would furnish included drugs to included Medicare beneficiaries. The effect of the model on individual hospitals, physicians, practitioners, and other providers and suppliers would depend on individual practice patterns and the drugs that would be selected for inclusion.
This ANPRM is a general solicitation of comments on several options pertaining to the potential IPI Model and thereby not subject to OMB review as stated in the implementing regulations of the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501
Because of the large number of public comments we normally receive on
In accordance with the provisions of Executive Order 12866, this ANPRM was reviewed by the Office of Management and Budget.
Fish and Wildlife Service, Interior.
Proposed rule; document availability and reopening of comment period.
We, the U.S. Fish and Wildlife Service (Service), announce the reopening of the public comment period on the August 6, 2008, proposed rule to remove the Hawaiian hawk or io (
The comment period for the proposed rule published August 6, 2008, at 73 FR 45680 is reopened. To ensure that we are able to consider your comments and information, they must be received or postmarked no later than November 29, 2018. Please note that, if you are using the Federal eRulemaking Portal (see
You may submit comments by one of the following methods:
(1)
(2)
We request that you send comments only by the methods described above. We will post all comments on
Mary Abrams, Field Supervisor, telephone: 808-792-9400. Direct all questions or requests for additional information to: U.S. Fish and Wildlife Service, Pacific Islands Fish and Wildlife Office, 300 Ala Moana Boulevard, Room 3-122, Honolulu, HI 96850. Persons who use a telecommunications device for the deaf (TDD) may call the Federal Relay Service at 800-877-8339.
On August 6, 2008, we published a proposed rule to delist the Hawaiian hawk (io) (73 FR 45680). Please refer to that proposed rule and the recovery plan (which can be found at:
Since the 2008 proposed rule, we opened three additional comment periods. During these comment periods, we received new or updated information on projected urban growth rates and conversion of agriculture lands to unsuitable Hawaiian hawk habitat; and potential effects of climate change (
Since the 2014 notice to reopen the comment period, we received updated information on trends in human population growth, urbanization, and land subdivision; biocontrol efforts for strawberry guava; impacts from ROD and climate change; and recent volcanic activity. We have also received some preliminary data from an in-house population viability assessment (PVA) (Vorsino and Nelson 2016, unpublished data). In addition, we are not aware of any changes in the status of the biofuel crop production or processing facility on the island since 2014 that would impact the status of the Hawaiian hawk.
Although trends in urban and exurban growth, and land subdivision show upward movement, the rate of growth has slowed. Population growth for Hawaii County between 2010 and 2017 was 1.1 percent annually, 0.5 percent lower than the 1.6 projection in 2012 (Hawaii Department of Business, Economic Development and Tourism (HDBEDT) 2018, in litt.). The number of new homes built per year has also decreased (County of Hawaii 2015, p. 146). Most urban and exurban growth is occurring in or adjacent to already developed areas (County of Hawaii 2015, p. 77, 150). We expect residential and exurban construction for Hawaii County to continue at a similar pace in the foreseeable future as indicated by expected human population growth for Hawaii County and home construction for the island of Hawaii for the last three decades (County of Hawaii 2010, tables 16.1-16.13; County of Hawaii 2015, pp. 144-146, 149-150; HDBEDT 2018, in litt.). Urban and exurban growth and subdivisions in Puna may slow even more due to the recent volcanic activity of Kilauea, which began in May 2018. The north Kona region has one of the highest urban and exurban growth rates on the island (County of Hawaii 2015, p. 11), as well as one of the highest densities of Hawaiian hawk (Gorresen
Since the successful deployment in 2012 of a biocontrol agent for strawberry guava (the Brazilian scale insect,
Hawaiian hawks frequently nest in native ohia (
Although new information shows negative habitat trends due to urbanization, nonnative plant species invasion, and ROD, efforts at habitat restoration that benefit the Hawaiian hawk are being implemented and are achieving success.
Both State and private foresters report an increase in forest areas on the island of Hawaii, particularly in native forest areas (Koch and Walter 2018, in litt.). Starting at the turn of the century, several large landowners (private, Federal, and State) have ended their
There has also been a marked increase in protection of native forests-which combined with an increase in forest areas results in increased protection for the Hawaiian hawk by protecting potential nesting, breeding, and hunting habitat. Several large conservation efforts across the island are being implemented by Federal, State, and private landowners, often in collaborative efforts.
Fencing and ungulate removal at Puu Waawaa Forest Bird Sanctuary and parts of the State's Natural Area Reserve System contribute to Hawaiian hawk habitat restoration (Gorresen
In 2016, the Governor of Hawaii initiated the Sustainable Hawaii Initiative (Initiative) in response to the 2016 World Conservation Congress Legacy Commitment to protect 30 percent (253,000 ac (102,385 ha)) of Hawaii's highest priority watershed forests by 2030 (
Over the past 6 years, the Hawaiian Legacy Reforestation Initiative (HLRI) has converted 1,000 ac (405 ha) of denuded pastureland into an intact ecosystem with over 300,000 endemic trees (
Additional ongoing conservation efforts (
At the onset of the most recent Kilauea volcano eruption (May 2018), primarily private lands were impacted; however, more recently the ongoing eruption has impacted native forest areas. In June 2018, the 1,514 ac (613 ha) Malama Ki Forest Reserve (FR) and surrounding areas were either buried by acres of lava or scorched by fumes of sulphur dioxide (Bergfield 2018, in litt.; KHON2 2018, in litt.). This area previously provided habitat for endangered forest birds and plants, and other native species. We do not have an exact number of how much native forest has been, or will be, lost as the eruption is ongoing. The Kilauea eruption is so far concentrated to the East Rift Zone area (USGS 2018, in litt.).
The island of Hawaii, like the island chain, has fortunately evaded most hurricanes due to the surrounding cool water. An exception occurred in 2014 with Hurricane Iselle. Although Hurricane Iselle morphed into a tropical storm before making landfall on the island, it caused extensive canopy loss in some regions of the island (Federal Emergency Management Agency (FEMA) 2014, in litt.). Iselle was the strongest tropical storm to make landfall on the island of Hawaii in recorded history. In 2016, Hurricane Darby made landfall on the island of Hawaii but as a much weaker tropical storm. While
A preliminary female specific stochastic PVA model for the Hawaiian hawk was developed (Vorsino and Nelson 2016, unpublished data) using the mean and variance values of age-specific survival and fecundity (ability and willingness to produce offpring) in native, mixed native-exotic, and exotic habitat (Gorresen
Current analysis of biodiesel fuel development indicates that construction and testing of facilities on the island of Hawaii has plateaued at 2014 levels, with just one biodiesel facility on the island. In addition to the other information we request in Public Comments below, we request new information on the actual conversion of agricultural land to crops for biodiesel fuel production, including former and current crop type and acreage.
Section 4(g)(1) of the Act requires us, in cooperation with the States, to implement a monitoring program for not less than 5 years for all species that have been delisted due to recovery. The purpose of this requirement is to develop a program that detects the failure of any delisted species to sustain itself without the protective measures provided by the Act. If, at any time during the monitoring period, data indicate that protective status under the Act should be reinstated, we can initiate listing procedures, including, if appropriate, emergency listing.
The Service has developed a draft post-delisting monitoring (PDM) plan for Hawaiian hawk in cooperation with the State of Hawaii Department of Land and Natural Resources, Division of Forestry and Wildlife (DOFAW); the National Park Service (NPS); and the U.S. Geological Survey, Ecosystem Mission Area (formerly the Biological Resources Division). The draft PDM plan includes monitoring the Hawaiian hawk population every 5 years for 20 years and is designed to verify that the Hawaiian hawk remains secure from risk of extinction after its removal from the Federal List of Endangered and Threatened Wildlife. While not required, with this notice, we are again soliciting public comments and peer review on the draft PDM plan, which can be found on
We intend that any final action resulting from the proposal will be based on the best scientific and commercial data available and will be as accurate and effective as possible. To ensure our determination is based on the best available scientific and commercial information, we request information on the Hawaiian hawk from governmental agencies, native Hawaiian groups, the scientific community, industry, and any other interested parties. We request comments or suggestions on our August 6, 2008 (73 FR 45680), proposal to delist the Hawaiian hawk; our draft PDM plan; new information presented in this
(1) The species' biology, range, and population trends, including:
(a) Life history, ecology, and habitat use of the Hawaiian hawk, as well as the species' use of koa plantations and exurban areas;
(b) Range, distribution, population size, and population trends;
(c) Positive and negative effects of current and foreseeable land management practices on the Hawaiian hawk, including conservation efforts associated with watershed partnerships (
(d) Potential effects of temperature and rainfall change on fire frequency and intensity and forest type and distribution;
(e) Potential impacts of ROD and climate change (
(f) Potential impacts of the recent Kilauea Volcano eruptions.
(2) The factors, as detailed in the August 6, 2008, proposed rule (73 FR 45680), that are the basis for making a listing/delisting/downlisting determination for a species under section 4(a) of the Act, which are:
(a) The present or threatened destruction, modification, or curtailment of its habitat or range;
(b) Overutilization for commercial, recreational, scientific, or educational purposes;
(c) Disease or predation;
(d) The inadequacy of existing regulatory mechanisms; or
(e) Other natural or manmade factors affecting its continued existence.
(3) Input or considerations for post-delisting monitoring of the Hawaiian hawk.
You may submit your information by one of the methods listed in
Information and supporting documentation that we receive and use in preparing the proposal will be available for you to review at
If you submitted comments or information previously on the August 6, 2008, proposed rule (73 FR 45680); the February 11, 2009, document that made available our draft PDM plan (74 FR 6853); the June 5, 2009, publication announcing public hearings and reopening the proposal's and draft PDM
A complete list of references cited is available on the internet at
The primary authors of this document are staff of the Service's Pacific Islands Fish and Wildlife Office (see
The authority for this action is the Endangered Species Act of 1973, as amended (16 U.S.C. 1531
Commission on Civil Rights.
Announcement of meetings.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission), and the Federal Advisory Committee Act (FACA), that a meeting of the New York Advisory Committee to the Commission will convene by conference call at 12:00 p.m. (EDT) on: Friday, November 9, 2018. The purpose of the meeting is to discuss topics of study.
Friday, November 9, 2018 at 12:00 p.m. EDT
David Barreras, at
Interested members of the public may listen to the discussion by calling the following toll-free conference call-in number: 1-877-260-1479 and conference ID# 6006921. Please be advised that before placing them into the conference call, the conference call operator will ask callers to provide their names, their organizational affiliations (if any), and email addresses (so that callers may be notified of future meetings). Callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free conference call-in number.
Persons with hearing impairments may also follow the discussion by first calling the Federal Relay Service at 1-800-977-8339 and providing the operator with the toll-free conference call-in number: 1-877-260-1479 and conference ID# 6006921.
Members of the public are invited to make statements during the open comment period of the meetings or submit written comments. The comments must be received in the regional office approximately 30 days after each scheduled meeting. Written comments may be mailed to the Midwest Regional Office, U.S. Commission on Civil Rights, 230 S Dearborn Street, Suite 2120, Chicago, IL 60604, faxed to (312) 353-8324, or emailed to David Barreras at
Records and documents discussed during the meeting will be available for public viewing as they become available at
On August 24, 2018, the Executive Secretary of the Foreign-Trade Zones (FTZ) Board docketed an application submitted by the Koochiching Economic Development Authority, grantee of FTZ 259, requesting subzone status subject to the existing activation limit of FTZ 259, on behalf of Digi-Key Corporation, in Thief River Falls, Minnesota.
The application was processed in accordance with the FTZ Act and Regulations, including notice in the
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Commerce) is amending the final results of the countervailing duty administrative review of crystalline silicon photovoltaic cells, whether or
Applicable October 30, 2018.
Gene H. Calvert, AD/CVD Operations, Office VII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone (202) 482-3586.
In accordance with section 751(a)(1) of the Tariff Act of 1930, as amended (the Act), and 19 CFR 351.221(b)(5), on July 23, 2018, Commerce published its final results in the administrative review of the countervailing duty order on solar cells from China for the period of review (POR) January 1, 2015, through December 31, 2015.
The merchandise covered by this order is crystalline silicon photovoltaic cells, and modules, laminates, and panels, consisting of crystalline silicon photovoltaic cells, whether or not partially or fully assembled into other products, including, but not limited to, modules, laminates, panels and building integrated materials. Merchandise covered by this order is currently classified in the Harmonized Tariff Schedule of the United States (HTSUS) under subheadings 8501.61.0000, 8507.20.80, 8541.40.6020, 8541.40.6030, and 8501.31.8000. These HTSUS subheadings are provided for convenience and customs purposes; the written description of the scope of this order is dispositive. A full description of the scope of the order is contained in the
Section 751(h) of the Act and 19 CFR 351.224(f) define a “ministerial error” as an error in addition, subtraction, or other arithmetic function, clerical error resulting from inaccurate copying, duplication, or the like, and any other similar type of unintentional error which the Secretary considers ministerial. Commerce finds that an error alleged by Canadian Solar regarding the calculation of the benchmark used to calculate benefits in the Aluminum Extrusions for Less Than Adequate Remuneration (LTAR) Program constitutes a ministerial error within the meaning of 19 CFR 351.224(f).
In accordance with section 751(h) of the Act and 19 CFR 351.224(e), we are amending the
As a result of correcting the ministerial error, we determine the countervailable subsidy rates for the producers/exporters under review to be as follows:
Review-Specific Average Rate Applicable to the Non-Selected Companies Subject to this Review:
Normally, Commerce would issue appropriate assessment instructions to U.S. Customs and Border Protection (CBP) 15 days after the date of publication of these amended final results of review, to liquidate shipments of subject merchandise produced and/or exported by the companies listed above entered, or withdrawn from warehouse, for consumption on or after January 1, 2015, through December 31, 2015. However, on August 31, 2018, and on September 20 and 24, 2018, the CIT enjoined liquidation of certain entries that are subject to the
Commerce intends to instruct CBP to collect cash deposits of estimated countervailing duties, in the amounts shown above for the companies listed above, on shipments of subject merchandise entered, or withdrawn from warehouse, for consumption on or after July 23, 2018, which is the date of publication of the
This notice also serves as a reminder to parties that are subject to administrative protective order (APO) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3), which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of the return/destruction of APO materials, or conversion to judicial protective order, is hereby requested. Failure to comply with the regulations and the terms of an APO is a sanctionable violation.
We intend to disclose the calculations performed for these amended final results to interested parties within five business days of the date of publication of this notice in accordance with 19 CFR 351.224(b).
We are issuing and publishing these results in accordance with section 751(h) and 777(i)(1) of the Act, and 19 CFR 351.224(e).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Commerce) preliminarily determines that steel wheels from the People's Republic of China (China) are being, or are likely to be, sold in the United States at less-than-fair-value (LTFV) for the period of investigation (POI) July 1, 2017, through December 31, 2017. Interested parties are invited to comment on this preliminary determination.
Applicable October 30, 2018.
Lingjun Wang, AD/CVD Operations, Office VII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-2316.
This preliminary determination is made in accordance with section 733(b) of the Tariff Act of 1930, as amended (the Act). Commerce published the notice of initiation of this investigation on April 24, 2018.
The products covered by this investigation are steel wheels from China. For a complete description of the scope of this investigation,
In accordance with the preamble to Commerce's regulations,
Commerce is conducting this investigation in accordance with section 731 of the Act. Pursuant to section 776(a) and (b) of the Act, we have preliminarily relied upon facts otherwise available, with adverse inferences, for the China-wide entity because it did not respond to our requests for information. Specifically, two mandatory respondents withdrew their participation, and no other companies have demonstrated their eligibility for a separate rate; thus, all companies are preliminarily found to be part of the China-wide entity. Furthermore, we find that the China-wide entity's lack of participation, including the failure of certain parts of the China-wide entity to respond to Commerce's questionnaires, constitute circumstances under which it is reasonable to conclude that the China-wide entity as a whole failed to cooperate to the best of its ability to comply with Commerce's requests for information. For a full description of the methodology underlying Commerce's preliminary determination,
Commerce preliminarily determines that the following estimated weighted-average dumping margins exist:
In accordance with section 733(d)(2) of the Act, Commerce will direct U.S. Customs and Border Protection (CBP) to suspend liquidation of subject merchandise as described in the scope of the investigation section entered, or withdrawn from warehouse, for consumption on or after the date of publication of this notice in the
To determine the cash deposit rate, Commerce normally adjusts the estimated weighted-average dumping margin by the amount of domestic subsidy pass-through and export subsidies determined in a companion CVD proceeding when CVD provisional measures are in effect. Accordingly, where Commerce has made a preliminary affirmative determination for domestic subsidy pass-through or export subsidies, Commerce has offset the calculated estimated weighted-average dumping margin by the appropriate rate(s). As discussed in the Preliminary Decision Memorandum, we have made no adjustment for domestic subsidy pass-through. As further explained in the Preliminary Decision Memorandum, as an extension of our AFA finding for the China-wide entity, the appropriate export subsidy adjustment is the lowest amount of export subsidies found for any respondent in the companion CVD investigation, which is zero.
These suspension of liquidation instructions will remain in effect until further notice.
Normally, Commerce discloses to interested parties the calculations performed in connection with a preliminary determination within five days of its public announcement or, if there is no public announcement, within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b). However, because Commerce preliminarily applied total AFA to companies in this investigation in accordance with section 776 of the Act, and the applied AFA rate is based solely on the petition, there are no calculations to disclose.
Because the mandatory respondents withdrew their participation, Commerce preliminarily determines each of the mandatory respondents to have been uncooperative, and verification of Sunrise and Jingu will not be conducted.
Case briefs or other written comments may be submitted to the Assistant Secretary for Enforcement and Compliance no later than 45 days after the date of publication of the preliminary determination, unless the Secretary alters the time limit. Rebuttal briefs, limited to issues raised in case briefs, may be submitted no later than five days after the deadline date for case briefs.
Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing, limited to issues raised in the case and rebuttal briefs, must submit a written request to the Assistant Secretary for Enforcement and Compliance, U.S. Department of Commerce, within 30 days after the date of publication of this notice. Requests should contain the party's name, address, and telephone number, the number of participants, whether any participant is a foreign national, and a list of the issues to be discussed. If a request for a hearing is made, Commerce intends to hold the hearing at the U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230, at a time and date to be determined. Parties should confirm the date, time, and location of the hearing two days before the scheduled date.
Section 735(a)(1) of the Act and 19 CFR 351.210(b)(1) provide that Commerce will issue the final determination within 75 days after the date of its preliminary determination. However, on August 15, 2018, pursuant to section 735(a)(2) of the Act, Sunrise requested that Commerce postpone the final determination and extend provisional measures from four months to six months.
In accordance with section 733(f) of the Act, Commerce will notify the International Trade Commission (ITC) of its preliminary determination of sales at LTFV. If the final determination is affirmative, the ITC will determine before the later of 120 days after the date of this preliminary determination or 45 days after the final determination whether imports of the subject merchandise are materially injuring, or threaten material injury to, the U.S. industry.
This determination is issued and published in accordance with sections 733(f) and 777(i)(1) of the Act and 19 CFR 351.205(c).
The merchandise subject to the investigation is certain on-the-road steel wheels, discs, and rims for tubeless tires, with a nominal rim diameter of 22.5 inches and 24.5 inches, regardless of width. Certain on-the-road steel wheels with a nominal wheel diameter of 22.5 inches and 24.5 inches are generally for Class 6, 7, and 8 commercial vehicles (as classified by the Federal Highway Administration Gross Vehicle Weight Rating system), including tractors, semi-trailers, dump trucks, garbage trucks, concrete mixers, and buses, and are the current standard wheel diameters for such applications. The standard widths of certain on-the-road steel wheels are 7.5 inches, 8.25 inches, and 9.0 inches, but all certain on-the-road steel wheels, regardless of width, are covered by the scope. While 22.5 inches and 24.5 inches are standard wheel sizes used by Class 6, 7, and 8 commercial vehicles, the scope covers sizes that may be adopted in the future for Class 6, 7, and 8 commercial vehicles.
The scope includes certain on-the-road steel wheels with either a “hub-piloted” or “stud-piloted” mounting configuration, and includes rims and discs for such wheels, whether imported as an assembly or separately. The scope includes certain on-the-road steel wheels, discs, and rims, of carbon and/or alloy steel composition, whether cladded or not cladded, whether finished or not finished, and whether coated or uncoated. All on-the-road wheels sold in the United States are subject to the requirements of the National Highway Traffic Safety Administration and bear markings, such as the “DOT” symbol, indicating compliance with applicable motor vehicle standards.
Excluded from the scope are:
(1) Steel wheels for tube-type tires that require a removable side ring;
(2) aluminum wheels;
(3) wheels where steel represents less than fifty percent of the product by weight; and
(4) steel wheels that do not meet National Highway Traffic Safety Administration requirements, other than the rim marking requirements found in 49 CFR 571.120S5.2.
Imports of the subject merchandise are currently classified under the following Harmonized Tariff Schedule of the United States (HTSUS) subheadings: 8708.70.4530, 8708.70.4560, 8708.70.6030, 8708.70.6060, 8716.90.5045, and 8716.90.5059. Merchandise meeting the scope description may also enter under the following HTSUS subheadings: 4011.20.1015, 4011.20.5020, and 8708.99.4850. While HTSUS subheadings are provided for convenience and customs purposes, the written description of the subject merchandise is dispositive.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; receipt of application.
Notice is hereby given that SeaWorld, LLC., 9205 Southpark Center Loop, Suite 400, Orlando, FL 32819 (Responsible Party: Christopher Dold, DVM), has applied in due form for a scientific research and enhancement permit for one non-releasable beluga whale (
Written, telefaxed, or email comments must be received on or before November 29, 2018.
The application and related documents are available for review by selecting “Records Open for Public Comment” from the “Features” box on the Applications and Permits for Protected Species (APPS) home page,
These documents are also available upon written request or by appointment in the Permits and Conservation Division, Office of Protected Resources, NMFS, 1315 East-West Highway, Room 13705, Silver Spring, MD 20910; phone (301) 427-8401; fax (301) 713-0376.
Written comments on this application should be submitted to the Chief, Permits and Conservation Division, at the address listed above. Comments may also be submitted by facsimile to (301) 713-0376, or by email to
Those individuals requesting a public hearing should submit a written request to the Chief, Permits and Conservation Division at the address listed above. The request should set forth the specific reasons why a hearing on this application would be appropriate.
Amy Sloan, Jennifer Skidmore, or Courtney Smith, (301) 427-8401.
The subject permit is requested under the authority of the Marine Mammal Protection Act of 1972, as amended (MMPA; 16 U.S.C. 1361
The applicant proposes to conduct research on and provide long-term care for one male beluga whale calf from the Cook Inlet DPS. The calf stranded alone as a neonate when he was less than a month old, and was rescued and rehabilitated by the Alaska marine mammal stranding network under the authority of the NMFS Marine Mammal Health and Stranding Response Program's (MMHSRP) scientific research and enhancement permit. Based on his young age, health conditions, and need for socialization with other beluga whales, NMFS determined him to be non-releasable and unable to survive in the wild, and chose SeaWorld of Texas to accept Tyonek into their beluga population, which was best suited for his needs. NMFS followed the standard placement process for non-releasable marine mammals as outlined in the NMFS Placement Process for Non-releasable Marine Mammals, No. 02-308-02, which is available at:
SeaWorld's proposed research activities for this beluga whale include investigations of vocalizations (passive recordings) and hearing development (auditory evoked potential measurements). The proposed enhancement would include educational presentations on topics including the endangered status and current threats to the Cook Inlet DPS; continued daily husbandry care (feeding, training, and monitoring growth (measurements, weight, ultrasound)); veterinary care (exams and biological sampling including but not limited to blood, exhalate, swabs, urine, feces; and treatments as warranted); and behavioral observations and enrichment. This animal would be placed on public display incidental to the proposed activities but would not be used in interactive programs with the public or trained for performance. Presentations to educate the public may include demonstrations of trained husbandry and enrichment behaviors as well as natural behaviors. The permit is requested for a 5-year period, the maximum duration of a permit.
In compliance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321
NMFS has forwarded the application to the Marine Mammal Commission and its Committee of Scientific Advisors.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; issuance of permits.
Notice is hereby given that individuals and institutions have been issued Letters of Confirmation for activities conducted under the General Authorization for Scientific Research on marine mammals. See
The Letters of Confirmation and related documents are available for review upon written request or by appointment in the following office:
Permits and Conservation Division, Office of Protected Resources, NMFS, 1315 East-West Highway, Room 13705, Silver Spring, MD 20910; phone (301) 427-8401; fax (301) 713-0376.
Office of Protected Resources, Permits and Conservation Division, (301) 427-8401.
The requested Letters of Confirmation have been issued under the authority of the Marine Mammal Protection Act of 1972, as amended (16 U.S.C. 1361
In compliance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321
Office for Coastal Management, National Ocean Service, National Oceanic and Atmospheric Administration, U.S. Department of Commerce.
Public meeting notice.
Notice is hereby given that a public meeting will be held for the purpose of providing information and receiving comments on the preliminary recommendation by the State of Connecticut that portions of the Lower Connecticut River and Eastern Long Island Sound be proposed to NOAA for designation as a National Estuarine Research Reserve.
The public meeting will be held at 6 p.m. on November 13, 2018 in the Academic Building Auditorium at the University of Connecticut's Avery Point campus, located at 1084 Shennecossett Rd, Groton, CT 06340.
The proposed research reserve site is comprised of the following state-owned properties: Lord Cove Wildlife Management Area; Great Island Wildlife Management Area; Bluff Point State Park and Coastal Reserve and Natural Area Preserve; Haley Farm State Park; and the public trust portions of waterbodies defined by:
(a) Long Island Sound ranging approximately west to east from the mouth of the Connecticut River to Mason's Island and north to south waterward of the mean high water
(b) the area waterward of the mean high shoreline of the lower Thames River from approximately the Gold Star Bridge south to the area described in (a);
(c) the area waterward of the mean high shoreline of the lower Connecticut River from approximately Lord Cove south to the area described in (a).
The views of interested persons and organizations regarding the proposed site recommendation are solicited. This information may be expressed orally and in written statements. A presentation about the proposed site and the National Estuarine Research Reserve System will be provided. Written comments may be also be sent to: Kevin O'Brien, Connecticut Department of Energy and Environmental Protection—Land & Water Resources Division, 79 Elm Street, Hartford, CT 06106-5127 or to:
The research reserve system is a federal and state partnership program administered by the federal government, specifically the National Oceanic and Atmospheric Administration (NOAA). The research reserve system currently has 29 sites and protects more than 1.3 million acres of estuarine and Great Lakes habitat for long-term research, monitoring, education, and stewardship. Established by the Coastal Zone Management Act of 1972, each reserve is managed by a lead state agency or university, with input from local partners. NOAA provides partial funding and national programmatic guidance.
This particular site selection effort is a culmination of several years of local, grassroots-support for a research reserve site in Connecticut. The preliminary site recommendation follows a comprehensive evaluation process that sought the views of the public, affected landowners, and other interested parties. State and local agency representatives, as well as estuarine experts, served as committee members and evaluated site proposals. The committee is recommending the Lower Connecticut River and Eastern Long Island Sound as the preferred site for the state to nominate to NOAA.
Ms. Erica Seiden, Office for Coastal Management, National Ocean Service, NOAA, 1305 East West Highway, N/OCM, Silver Spring, MD 20910 or Email:
Persons with disabilities please contact Michelle MarcAurele at the University of Connecticut Avery Point campus by November 6, 2018 to make arrangements. Phone: 860-405-9115, Email:
The Department of Commerce will submit to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. Chapter 35).
The National Marine Fisheries Service (NMFS) requires any U.S. citizen issued a Special Coral Reef Ecosystem Fishing Permit to complete logbooks and submit them to NMFS (50 CFR 665). The Special Coral Reef Ecosystem Fishing Permit is authorized under the Fishery Ecosystem Plans for American Samoa Archipelago, Hawaiian Archipelago, Mariana Archipelago, and Pacific Remote Island Areas. The information in the logbooks is used to obtain fish catch/fishing effort data on coral reef fishes and invertebrates harvested in designated low-use marine protected areas and on those listed in the regulations as potentially-harvested coral reef taxa in waters of the U.S. exclusive economic zone in the western Pacific region. These data are needed to determine the condition of the stocks, whether the current management measures are having the intended effects, and to evaluate the benefits and costs of changes in management measures. The logbook information includes interactions with protected species, including sea turtles, monk seals, and other marine mammals, which are used to monitor and respond to incidental takes of endangered and threatened marine species.
This information collection request may be viewed at reginfo.gov. Follow the instructions to view Department of Commerce collections currently under review by OMB.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
National Marine Fisheries Service, National Oceanic and Atmospheric Administration, Commerce.
Notice; request for nominations.
National Marine Fisheries Service, on behalf of the Secretary of Commerce, is seeking nominations for the General Advisory Committee to the U.S. delegation to the Inter-American Tropical Tuna Commission, as well as to a Scientific Advisory Subcommittee of the General Advisory Committee. The purpose of the General Advisory Committee and its Scientific Advisory Subcommittee is to provide public input
Nominations must be received no later than November 29, 2018.
Nominations should be directed to Barry Thom, Regional Administrator, NMFS West Coast Region, and may be submitted by any of the following means:
•
•
Taylor Debevec, NMFS West Coast Region; email:
The Tuna Conventions Act (16 U.S.C. 951
The Chair of the Pacific Fishery Management Council's (Pacific Council) Advisory Subpanel for Highly Migratory Fisheries and the Chair of the Western Pacific Fishery Management Council's (Western Pacific Council's) Advisory Committee shall be ex-officio members of the GAC by virtue of their positions advising those Councils. GAC members will be eligible to participate as members of the U.S. delegation to the Commission and its working groups to the extent that the Commission rules and space for delegations allow.
Meetings of the GAC, except when in executive session, shall be open to the public, and prior notice of meetings shall be made public in timely fashion. In accordance with Public Law 114-81, the GAC shall not be subject to the Federal Advisory Committee Act (5 U.S.C. App.).
Individuals appointed to serve as a member of the GAC shall serve without pay. While away from their homes or regular places of business to attend meetings of the GAC, they shall be allowed travel expenses, including per diem in lieu of subsistence, in the same manner as persons employed intermittently by the Federal Government are allowed expenses under 5 U.S.C. 5703. In addition, individuals appointed to serve as a member of the GAC shall not be considered Federal employees except for the purposes of injury compensation or tort.
The TCA also provides that the Secretary of Commerce, in consultation with the Secretary of State, shall appoint persons to serve on the subcommittee of the GAC, referred to here as the “Scientific Advisory Subcommittee” (SAS). The SAS shall be composed of no fewer than 5 and no more than 15 qualified scientists with balanced representation from the public and private sectors, including non-governmental conservation organizations. In determining whether a person is a qualified scientist the Secretary may consider, among other things, advanced degrees and/or publications in fields such as fisheries or marine science.
The SAS shall also function as the National Scientific Advisory Committee which is required to be established pursuant to Article XI of the Agreement on the International Dolphin Conservation Program (AIDCP). In this regard, the SAS shall perform the functions of the National Scientific Advisory Committee as specified in Annex VI of the AIDCP. These functions include, but are not limited to: (1) Receiving and reviewing relevant data, including data provided to NMFS by IATTC staff; (2) advising and recommending measures and actions to the U.S. Government that should be undertaken to conserve and manage stocks of living marine resources in the eastern Pacific Ocean; (3) making recommendations to the U.S. Government regarding research needs related to the eastern Pacific Ocean tuna purse seine fishery; (4) promoting the regular and timely full exchange of data among the AIDCP Parties on a variety of matters related to the implementation of the AIDCP; and (5) consulting with other experts, as necessary, in order to achieve the objectives of the AIDCP.
Members of the SAS/National Scientific Advisory Committee shall receive no compensation for their service.
Each member of the GAC shall be appointed for a term of 3 years and may be reappointed. The Secretary of Commerce and the Secretary of State shall provide the GAC with relevant information concerning fisheries and international fishery agreements. The Secretary of Commerce shall provide to the GAC such administrative and technical support services that are necessary for its effective functioning in a timely manner.
Applications for the GAC and the SAS/National Scientific Advisory Committee should be submitted to NMFS West Coast Region (see
(1) Full name, address (home and business, if different), telephone, and email address of nominee;
(2) Specification about whether the application is for the GAC or the SAS/National Scientific Advisory Committee or both;
(3) Nominee's organization(s) or professional affiliation(s) serving as the basis for the nomination;
(4) Background statement describing the nominee's qualifications and experience, especially as related to fisheries for tuna and tuna-like species in the eastern Pacific Ocean or other factors relevant to the implementation of the Convention Establishing the IATTC or the AIDCP. Applications to the SAS should highlight advanced degrees and academic publications; and
(5) A written statement from the nominee of intent to participate actively and in good faith in the meetings and activities of either the GAC or the SAS/National Scientific Advisory Committee, or both.
Applicants who submitted material in response to the
16 U.S.C. 951
U.S. Army Corps of Engineers, DoD.
Information collection notice.
In compliance with the
Consideration will be given to all comments received by December 31, 2018.
You may submit comments, identified by docket number and title, by any of the following methods:
•
•
Any associated form(s) for this collection may be located within this same electronic docket and downloaded for review/testing. Follow the instructions at
To request more information on this proposed information collection or to obtain a copy of the proposal and associated collection instruments, please write to the U.S. Army Corps of Engineers Omaha District, ATTN: Kelly Baxter, 1616 Capitol Ave., Ste. 9000, Omaha, NE 68102; call at 402-995-2447; or email at
For a secondary source to request more information on this proposed information collection, please write to the U.S. Army Corps of Engineers Walla Walla District, ATTN: Karen Zelch, 201 N 3rd Ave, Walla Walla, WA 99362; call at 509-527-7251; or email at
The purpose of this survey effort is to gather information that will support development of a water-based recreational demand model for the Columbia River Basin in Washington, Oregon, Idaho, and western Montana. The proposed design involves a mail survey for preliminary screening to identify eligible recreators, followed by a telephone survey of eligible recreators to collect data on recreational trips and activities within the region. The model will be used to evaluate recreational impacts associated with alternatives identified within the CRSO EIS.
We anticipate that approximately 11,500 households will complete the mail screener. Based on the results of a small pretest, we expect that it will take approximately 1 minute to read the screener letter and approximately 5 minutes to complete the screener questionnaire (total of 6 minutes per respondent). Approximately 1,242 eligible adults within those households will complete the follow-up telephone survey. Also based on the results of a small pretest, we expect that it will take approximately 20 minutes to complete the follow-up telephone survey. Based on that data, the burden for 10,258 households will be 6 minutes. The burden for 1,242 eligible adults will be a total of 26 minutes. This yields a total respondent burden estimate of 1,564 hours.
Defense Security Cooperation Agency, Department of Defense.
Arms sales notice.
The Department of Defense is publishing the unclassified text of an arms sales notification.
DSCA at
This 36(b)(1) arms sales notification is published to fulfill the requirements of section 155 of Public Law 104-164 dated July 21, 1996. The following is a copy of a letter to the Speaker of the House of Representatives, Transmittal 18-34 with attached Policy Justification and Sensitivity of Technology.
(i)
(iii)
Six (6) P-8A Patrol Aircraft, which includes:
Commercial engines; Tactical Open Mission Software (TOMS); Electro-Optical (E.O.) and Infrared (IR) MX-20HD; AN/AAQ-2(V)1 Acoustic System; AN/APY-10 Radar; ALQ-240 Electronic Support Measures; AN/ALE-47 Counter Measures Dispensing System; support equipment; operation support systems; maintenance trainer/classrooms; publications; software, engineering, and logistics technical assistance; foreign Liaison officer support, contractor engineering technical services; repair and return; transportation; aircraft ferry; and other associated training, logistics, support equipment and services.
(iv)
(v)
(vi)
(vii)
(viii)
* As defined in Section 47(6) of the Arms Export Control Act.
The Republic of Korea (ROK) has requested to buy six (6) P-8A Patrol Aircraft, which includes: nine (9) Multifunctional Information Distribution System Joint Tactical Radio Systems 5 (MIDS JTRS 5) (one (1) for each aircraft, one (1) for the Tactical Operations Center (TOC) and two (2) as spares); fourteen (14) LN-251 with Embedded Global Positioning Systems (GPS)/Inertial Navigations Systems (EGIs) (two (2) for each aircraft and two (2) as spares); and forty-two (42) AN/AAR-54 Missile Warning Sensors (six (6) for each aircraft and six (6) as spares). Also included are commercial engines; Tactical Open Mission Software (TOMS); Electro-Optical (E.O.) and Infrared (IO) MX-20HD; AN/AAQ-2(V)1 Acoustic System; AN/APY-10 Radar; ALQ-240 Electronic Support Measures; AN/ALE-47 Counter Measures Dispensing System; support equipment; operation support systems; maintenance trainer/classrooms; publications; software, engineering, and logistics technical assistance; foreign liaison officer support; contractor engineering technical services; repair and return; transportation; aircraft ferry; and other associated training, logistics, support equipment and services. The total estimated program cost is $2.1 billion.
The ROK is one of the closest allies in the INDOPACOM Theater. The proposed sale will support U.S. foreign policy and national security objectives by enhancing Korea's naval capabilities to provide national defense and significantly contribute to coalition operations.
The ROK procured and has operated U.S.-produced P-3 Maritime Surveillance Aircraft (MSA) for over 25 years, providing interoperability and critical capabilities to coalition maritime operations. The ROK has maintained a close MSA acquisition and sustainment relationship with the U.S. Navy over that period. The proposed sale will allow the ROK to modernize and sustain its MSA capability for the next 30 years. As a long-time P-3 operator, the ROK will have no difficulty transitioning its MSA force to P-8A.
The proposed sale of this equipment and support does not alter the basic military balance in the region.
The prime contractor will be The Boeing Company, Seattle, WA. Additional contractors include: ASEC; Air Cruisers Co LLC; Arnprior Aerospace, Canada; AVOX Zodiac Aerospace; BAE; Canadian Commercial Corporation (CCC)/EMS; Compass; David Clark; DLS or ViaSat, Carlsbad, CA; DRS; Exelis, McLean, VA; GC Micro, Petaluma, CA; General Dynamics; General Electric, UK; Harris; Joint Electronics; Lockheed Martin; Martin Baker; Northrop Grumman Corp, Falls Church, VA; Pole Zero, Cincinnati, OH; Raytheon, Waltham, MA; Raytheon, UK; Rockwell Collins, Cedar Rapids, IA; Spirit Aero, Wichita, KS; Symmetries Telephonics, Farmingdale, NY; Terma, Arlington, VA; Viking; and WESCAM.
The purchaser typically requests offsets. There are no known offset agreements proposed in connection with this potential sale. Any offset agreement will be defined in negotiations between the Purchaser and the prime contractor.
Implementation of this proposed sale will require approximately three (3) U.S. government personnel and ten (10) contractor personnel to support the program in country.
There will be no adverse impact on U.S. defense readiness as a result of this proposed sale.
(vii)
1. The P-8A aircraft is a militarized version of the Boeing 737-800 Next Generation (NG) commercial aircraft. The P-8A is replacing the P-3C as the Navy's long-range Anti-Submarine Warfare (ASW), Anti-Surface Warfare (ASuW), Intelligence, Surveillance and Reconnaissance (ISR) aircraft. The overall highest classification of the P-8A weapon system is SECRET. The P-8A mission systems hardware is largely UNCLASSIFIED, while individual software elements (mission systems, acoustics, ESM, EWSP, etc.) are classified up to SECRET.
2. P-8A mission systems include:
a. Tactical Open Mission Software (TOMS). TOMS functions include environment planning, tactical aids, weapons planning aids, and data correlation. TOMS includes an algorithm for track fusion which automatically correlates tracks produced by on board and off board sensors.
b. Electro-Optical (E.O.) and Infrared (IR) MX-20HD. The E.O./IR system processes visible E.O. and IR spectrum to detect and image objects.
c. AN/AAQ-2(V)1 Acoustic System. The Acoustic sensor system is integrated within the mission system as the primary sensor or the aircraft ASW missions. The system has multi-static active coherent (MAC) 64 sonobuoy processing capability and acoustic sensor prediction tools.
d. AN/APY-10 Radar. The aircraft radar is a direct derivative of the legacy AN/APS-137(V) installed in the P-3C. The radar capabilities include GPS Selective Availability Anti-Spoofing Module (SAASM), SAR and ISAR imagery resolutions, and periscope detection mode.
e. ALQ-240 Electronic Support Measures (ESM). This system provides real time capability for the automatic detection, location, measurement, and analysis of RF-signals and modes. Real time results are compared with a library of known emitters to perform emitter classification.
f. Electronic Warfare Self Protection (EWSP). The P-8A aircraft EWSP consists of the ALQ-213 Electronic Warfare Management System (EWMS), AN/AAR-54 Missile Warning Sensors and AN/ALE-47 Countermeasures Dispensing System (CMDS). The EWSP includes threat information. Technical data and documentation to be provided are UNCLASSIFIED.
g. Multifunctional Information Distribution System-Joint Tactical Radio System 5 (MIDS JTRS 5) is an advanced Link-16 Command, Control, Communications, and Intelligence (C3I) system incorporating high-capacity, jam-resistant, digital communication links for exchange of near real-time tactical information, including both data and vice, among air, ground, and sea elements. The MIDS JTRS 5 terminal hardware, publications, performance specifications, operational capability, parameters, vulnerabilities to countermeasures, and software documentation are classified CONFIDENTIAL. The classified information to be provided consists of that which is necessary for the operation, maintenance, and repair (through intermediate level) of the data link terminal, installed systems, and related software.
h. The Embedded Global Positioning System (EGI)-Inertial Navigation System (INS)/LN-251 is a sensor that combines Global Positioning System (GPS) and inertial sensor inputs to provide accurate location information for navigation and targeting. The EGI-INS/LN-251 is UNCLASSIFIED. The GPS cryptovariable keys needed for highest GPS accuracy are classified up to SECRET.
3. If a technologically advanced adversary were to obtain access of the P-8A specific hardware and software elements, systems could be reverse engineering to discover USN capabilities and tactics. The consequences of the loss of this technology, to a technologically advanced or competent adversary, could result in the development of countermeasures or equivalent systems, which could reduce system effectiveness or be used in the development of a system with similar advanced capabilities.
4. A determination has been made that the recipient government can provide substantially the same degree of protection for the technology being released as the U.S. Government. This sale is necessary in furtherance of the U.S. foreign policy and national security objectives outlined in the Policy Justification.
5. All defense articles and services listed in this transmittal have been authorized for release and export to the Republic of Korea.
Federal Student Aid (FSA), Department of Education (ED).
Notice.
In accordance with the Paperwork Reduction Act of 1995, ED is proposing an extension of an existing information collection.
Interested persons are invited to submit comments on or before November 29, 2018.
To access and review all the documents related to the information collection listed in this notice, please use
For specific questions related to collection activities, please contact Beth Grebeldinger, 202-377-4018.
The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.
Federal Student Aid (FSA), Department of Education (ED).
Notice.
In accordance with the Paperwork Reduction Act of 1995, ED is proposing an extension of an existing information collection.
Interested persons are invited to submit comments on or before November 29, 2018.
To access and review all the documents related to the information collection listed in this notice, please use
For specific questions related to collection activities, please contact Beth Grebeldinger, 202-377-4018.
The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.
Federal Student Aid (FSA), Department of Education (ED).
Notice.
In accordance with the Paperwork Reduction Act of 1995, ED is proposing an extension of an existing information collection.
Interested persons are invited to submit comments on or before November 29, 2018.
To access and review all the documents related to the information collection listed in this notice, please use
For specific questions related to collection activities, please contact Beth Grebeldinger, 202-377-4018.
The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general
Office of Postsecondary Education (OPE), Department of Education (ED).
Notice.
In accordance with the Paperwork Reduction Act of 1995, ED is proposing a reinstatement of a previously approved information collection.
Interested persons are invited to submit comments on or before December 31, 2018.
To access and review all the documents related to the information collection listed in this notice, please use
For specific questions related to collection activities, please contact Harold Wells, 202-453-6131.
The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.
U.S. Department of Energy.
Notice and request for comments.
The Department of Energy (DOE), pursuant to the Paperwork Reduction Act of 1995, intends to extend for three years, an information collection request with the Office of Management and Budget (OMB).
Comments regarding this proposed information collection must be received on or before December 31, 2018. If you anticipate difficulty in submitting comments within that period, contact the person listed below as soon as possible.
Written comments may be sent to Eric Mulch at 1000 Independence Ave. SW, Washington, DC 20585 or by email at
Eric F. Mulch, Attorney-Adviser, at (202) 287-5746, or via email at
Comments are invited on: (a) Whether the extended collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. This information collection request contains: (1)
Section 161 of the Atomic Energy Act of 1954, 42 U.S.C. 2201, the Department of Energy Organization Act, 42 U.S.C 7101,
Office of Energy Efficiency and Renewable Energy, Department of Energy.
Notice of decision and order.
The U.S. Department of Energy (“DOE”) gives notice of a Decision and Order (Case Number 2017-007) that grants AHT Cooling Systems GmbH and AHT Cooling Systems USA Inc. (“AHT”) a waiver from specified portions of the DOE test procedure for determining the energy consumption of specified commercial refrigerators, freezers, and refrigerator-freezers (collectively “commercial refrigeration equipment”) basic models. Under the Decision and Order, AHT is required to test and rate the specified basic models of its commercial refrigeration equipment in accordance with the alternate test procedure specified in the Decision and Order.
The Decision and Order is effective on October 30, 2018. The Decision and Order will terminate upon the compliance date of any future amendment to the test procedure for commercial refrigeration equipment located at 10 CFR part 431, subpart C, appendix B that addresses the issues presented in this waiver. At such time, AHT must use the relevant test procedure for this equipment for any testing to demonstrate compliance with standards, and any other representations of energy use.
In accordance with Title 10 of the Code of Federal Regulations (10 CFR 431.401(f)(2)), DOE gives notice of the issuance of its Decision and Order as set forth below. The Decision and Order grants AHT a waiver from the applicable test procedure in 10 CFR part 431, subpart C, appendix B (“Appendix B”) for specified basic models of commercial refrigeration equipment, provided that AHT tests and rates such equipment using the alternate test procedure specified in the Decision and Order. AHT's representations concerning the energy consumption of the specified basic models must be based on testing according to the provisions and restrictions in the alternate test procedure set forth in the Decision and Order, and the representations must fairly disclose the test results. Distributors, retailers, and private labelers are held to the same requirements when making representations regarding the energy consumption of this equipment. (42 U.S.C. 6314(d))
Consistent with 10 CFR 431.401(j), not later than December 31, 2018, any manufacturer currently distributing in commerce in the United States equipment employing a technology or characteristic that results in the same need for a waiver from the applicable test procedure must submit a petition for waiver. Manufacturers not currently distributing such equipment in commerce in the United States must petition for and be granted a waiver prior to the distribution in commerce of that equipment in the United States. Manufacturers may also submit a request for interim waiver pursuant to the requirements of 10 CFR 431.401.
The Energy Policy and Conservation Act of 1975 (“EPCA”),
DOE's regulations set forth at 10 CFR 431.401 contain provisions that allow an interested person to seek a waiver from the test procedure requirements for a particular basic model when the petitioner's basic model for which the petition for waiver was submitted contains one or more design characteristics that either (1) prevent testing according to the prescribed test procedure, or (2) cause the prescribed test procedures to evaluate the basic model in a manner so unrepresentative of its true energy consumption characteristics as to provide materially inaccurate comparative data. 10 CFR 431.401(a)(1). A petitioner must include in its petition any alternate test procedures known to the petitioner to evaluate the basic model in a manner representative of its energy consumption characteristics. 10 CFR 431.401(b)(1)(iii).
DOE may grant a waiver subject to conditions, including adherence to alternate test procedures. 10 CFR 431.401(f)(2). As soon as practicable after the granting of any waiver, DOE will publish in the
The wavier process also provides that DOE may grant an interim waiver if it appears likely that the petition for waiver will be granted and/or if DOE determines that it would be desirable for public policy reasons to grant immediate relief pending a determination on the underlying petition for waiver. 10 CFR 431.401(e)(2). Within one year of issuance of an interim waiver, DOE will either: (i) Publish in the
By letter dated May 16, 2017, AHT submitted a petition for waiver and an application for interim waiver for specified basic models of commercial refrigeration equipment that are required to be tested using the commercial refrigeration equipment test procedure at 10 CFR part 431, subpart C, appendix B.
On June 4, 2018, DOE published a notice that announced its receipt of the petition for waiver and granted AHT an interim waiver. 83 FR 25658. (“Notice of Petition for Waiver”). In the Notice of Petition for Waiver, DOE presented AHT's claim that its specified basic models cannot be tested according to Appendix B due to their lack of defrost when operated in freezer mode. AHT requested an alternate test procedure, which would test the specified commercial freezer basic models according to appendix B, but with the test period starting after the unit achieves steady state conditions and the door-opening period starting 3 hours after the start of the test period.
As explained in the Notice of Petition for Waiver, DOE evaluated the alternate test procedure requested by AHT, as well as the operating manual for the commercial freezer basic models. DOE's test procedure requires beginning the test period at the start of a defrost cycle and recording data for 24 hours, and initiating a door-opening period 3 hours after the start of a defrost cycle. As such, for the specified basic models, which do not defrost, there is no defined start to either the test period or the door-opening period under DOE's test procedure. Based on review of the application for an interim waiver, DOE determined that the alternate test procedure that AHT suggested appropriately reflects the energy consumption of and is appropriate for the commercial freezer basic models identified in AHT's petition for waiver.
In the Notice of Petition for Waiver, DOE also solicited comments from interested parties on all aspects of the petition and the specified alternate test procedure, which was consistent with AHT's requested alternate approach. DOE received no comments in response to the Notice of Petition for Waiver.
For the reasons explained here and in the Notice of Petition for Waiver, DOE understands that absent a waiver, the commercial freezer basic models identified by AHT in its petition contain a design characteristic—lack of a defrost cycle when operated in freezer mode—that prevents testing and rating such models on a basis representative of their true energy consumption characteristics. DOE has reviewed the recommended procedure suggested by AHT and concludes that it will allow for the accurate measurement of the energy use of the equipment, while alleviating the testing problems associated with AHT's implementation of DOE's applicable commercial refrigeration equipment test procedure for the specified basic models. Thus, DOE is requiring that AHT test and rate the commercial freezer basic models for which it has requested a waiver according to the alternate test procedure specified in this Decision and Order, which is identical to the procedure provided in the interim waiver.
This Decision and Order is applicable only to the basic models listed within it and does not extend to any other basic models. DOE evaluates and grants waivers for only those basic models specifically set out in the petition, not future models that may be manufactured by the petitioner. AHT may request that the scope of this waiver be extended to include additional basic models that employ the same technology as those listed in this waiver. 10 CFR 431.401(g). AHT may also submit another petition for waiver from the test procedure for additional basic models that employ a different technology and meet the
DOE notes that it may modify or rescind the waiver at any time upon DOE's determination that the factual basis underlying the petition for waiver is incorrect, or upon a determination that the results from the alternate test procedure are unrepresentative of the basic models' true energy consumption characteristics. 10 CFR 431.401(k)(1). Likewise, AHT may request that DOE rescind or modify the waiver if the company discovers an error in the information provided to DOE as part of its petition, determines that the waiver is no longer needed, or for other appropriate reasons. 10 CFR 431.401(k)(2).
After careful consideration of all the material that was submitted by AHT in this matter, it is
(1) AHT must, as of the date of publication of this Order in the
(2) The alternate test procedure for the AHT basic models listed in paragraph (1) of this Order is the test procedure for commercial refrigeration equipment prescribed by DOE at 10 CFR part 431, subpart C, appendix B, except that the test period shall be selected as detailed below. All other requirements of Appendix B and DOE's regulations remain applicable.
The test shall begin when steady state conditions occur (per ASHRAE Standard 72-2005, Section 3, definitions, which defines steady state as “the condition where the average temperature of all test simulators changes less than 0.2 °C (0.4 °F) from one 24-hour period or refrigeration cycle to the next” ASHRAE 72-2005, Section 3, definitions). Additionally, the door-opening requirements shall be as defined in ASHRAE 72-2005 Section 7.2, with the exception that the eight-hour period of door openings shall begin three hours after the start of the test. Ambient temperature, test simulator temperatures, and all other data shall be recorded at three-minute intervals beginning at the start of the test and throughout the 24-hour testing period.
(3)
(4) This waiver shall remain in effect according to the provisions of 10 CFR 431.401.
(5) This waiver is issued on the condition that the statements, representations, and documentation provided by AHT are valid. If AHT makes any modifications to the controls or capabilities (
(6) Granting of this waiver does not release AHT from the certification requirements set forth at 10 CFR part 429.
Signed in Washington, DC, on October 16, 2018.
Office of Environmental Management, Department of Energy.
Notice of open meeting.
This notice announces a meeting of the Environmental Management Site-Specific Advisory Board (EM SSAB), Oak Ridge. The Federal Advisory Committee Act requires that public notice of this meeting be announced in the
Wednesday, November 14, 2018 6:00 p.m.
DOE Information Center, Office of Science and Technical Information, 1 Science.gov Way, Oak Ridge, Tennessee 37831.
Melyssa P. Noe, Alternate Deputy Designated Federal Officer, U.S. Department of Energy, Oak Ridge Office of Environmental Management (OREM), P.O. Box 2001, EM-942, Oak Ridge, TN 37831. Phone (865) 241-3315; Fax (865) 241-6932; Email:
Office of Environmental Management, Department of Energy.
Notice of open meeting.
This notice announces a meeting of the Environmental Management Site-Specific Advisory Board (EM SSAB), Paducah. The Federal Advisory Committee Act requires that public notice of this meeting be announced in the
Thursday, November 15, 2018 6:00 p.m.
West Kentucky Community and Technical College, Emerging Technology Center, 5100 Alben Barkley Drive, Paducah, Kentucky 42001.
Jennifer Woodard, Deputy Designated Federal Officer, Department of Energy Paducah Site Office, Post Office Box 1410, MS-103, Paducah, Kentucky 42001, (270) 441-6825.
Breaks Taken As Appropriate.
Take notice that on October 19, 2018, ISO New England Inc. submitted tariff filing per: Refund Report to be effective N/A, pursuant to the order issued by the Federal Energy Regulatory Commission (Commission) on September 20, 2018.
Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed on or before the comment date. On or before the comment date, it is not necessary to serve motions to intervene or protests on persons other than the Applicant.
The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at
This filing is accessible on-line at
Take notice that on October 11, 2018, National Fuel Gas Supply Corporation (National Fuel), 6363 Main Street, Williamsville, New York 14221, filed in Docket No. CP19-4-000, a Prior Notice Request pursuant to sections 157.205 and 157.216 of the Commission's regulations under the Natural Gas Act (NGA), and National Fuel's blanket certificate issued in Docket No. CP83-4-000, requesting authorization to plug and abandon one injection/withdrawal (I/W) well (Zoar Well 804-I) and abandon in place approximately 212 feet of 4-inch-diameter associated well line (AW 804) in the Zoar Storage Field located in Eerie County, New York. National Fuel states elevated levels of corrosion were found in the production casing of Zoar Well 804-I during evaluations and rehabilitation would be cost prohibitive due to the well's configuration and historically low volume deliverability, all as more fully described in the application which is on file with the Commission and open to public inspection. The filing may also be viewed on the web at
Any questions regarding this prior notice should be directed to Alice A. Curtiss, Deputy General Counsel, National Fuel Gas Supply Corporation, 6363 Main Street, Williamsville, New York 14221, by telephone at (716) 857-7075, by fax at (716) 857-7206, or by email at
Any person or the Commission's staff may, within 60 days after issuance of the instant notice by the Commission, file pursuant to Rule 214 of the Commission's Procedural Rules (18 CFR 385.214) a motion to intervene or notice of intervention and pursuant to section 157.205 of the regulations under the NGA (18 CFR 157.205), a protest to the request. If no protest is filed within the time allowed therefore, the proposed activity shall be deemed to be authorized effective the day after the time allowed for filing a protest. If a protest is filed and not withdrawn within 30 days after the allowed time for filing a protest, the instant request shall be treated as an application for authorization pursuant to section 7 of the NGA.
Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9, within 90 days of this Notice the Commission staff will either: Complete its environmental assessment (EA) and place it into the Commission's public record (eLibrary) for this proceeding; or issue a Notice of Schedule for Environmental Review. If a Notice of Schedule for Environmental Review is issued, it will indicate, among other milestones, the anticipated date for the Commission staff's issuance of the EA for this proposal. The filing of the EA in the Commission's public record for this proceeding or the issuance of a Notice of Schedule for Environmental Review will serve to notify federal and state agencies of the timing for the completion of all necessary reviews, and the subsequent need to complete all federal authorizations within 90 days of the date of issuance of the Commission staff's EA.
Persons who wish to comment only on the environmental review of this project should submit an original and two copies of their comments to the Secretary of the Commission. Environmental commenters will be placed on the Commission's environmental mailing list and will be notified of any meetings associated with the Commission's environmental review process. Environmental commenters will not be required to serve copies of filed documents on all other parties. However, the non-party commenters will not receive copies of all documents filed by other parties or issued by the Commission and will not have the right to seek court review of the Commission's final order.
The Commission strongly encourages electronic filings of comments, protests, and interventions in lieu of paper using the “eFiling” link at
This notice requests applications from those interested in being listed as potential panel members to assist in the Federal Energy Regulatory Commission's (Commission) study dispute resolution process for the integrated licensing process (ILP) of hydropower projects.
The Commission's ILP regulations pertaining to hydroelectric licensing under the Federal Power Act encourages informal resolution of study disagreements. In cases where this is not successful, a formal study dispute resolution process is available for state and federal agencies or Indian tribes with mandatory conditioning authority.
The ILP provides that the disputed study must be submitted to a dispute resolution panel consisting of a person from Commission staff, a person from the agency or Indian tribe referring the dispute to the Commission, and a third person selected by the other two panelists from a pre-established list of persons with expertise in the disputed resource area.
The role of the panel members is to make a finding, with respect to each disputed study request, on the extent to which each study criteria set forth in the regulations is or is not met,
TPMs can only be selected from a list of qualified persons (TPM list) that is developed and maintained by the Commission. This notice seeks additional members for the TPM list, which was originally compiled in 2004, 2010, and 2015. Current members of the TPM list do not need to reapply, but are encouraged to update their qualifications and contact information, if not current. Each qualified panel member will be listed by area(s) and sub-area(s) of technical expertise, for example Aquatic Resources—instream flows. The TPM list and qualifications will be available to the public on the Commission's website. All individuals submitting their applications to the Commission for consideration must meet the Commission's qualifications.
The applicant should describe in detail his/her qualifications in items 1-4 listed below.
1. Technical expertise, including education and experience in each resource area and sub-area for which the applicant wishes to be considered:
2. Knowledge of the effects of construction and operation of hydroelectric projects.
3. Working knowledge of laws relevant to the expertise, such as: The Fish and Wildlife Coordination Act, the Endangered Species Act, the Clean Water Act, the Coastal Zone Management Act, the Wild and Scenic Rivers Act, the Federal Power Act, or other applicable laws.
4. Ability to promote constructive communication about a disputed study.
Applicants must submit their applications along with the names and contact information of three references. Applications will be evaluated as they are received, and each applicant will be individually notified of the Commission's decision.
Kim Nguyen, Federal Energy Regulatory Commission, Office of Energy Projects, 888 First Street NE, Room 61-01, Washington, DC 20426, (202) 502-6105,
The staff of the Federal Energy Regulatory Commission (FERC or Commission) has prepared a final environmental impact statement (EIS) for the Calcasieu Pass Project, proposed by Venture Global Calcasieu Pass, LLC (Venture Global Calcasieu Pass) and TransCameron Pipeline, LLC (TransCameron Pipeline) in the above-referenced dockets. Venture Global Calcasieu Pass requests authorization to site, construct, and operate a natural gas liquefaction and storage facility, and marine export terminal in Cameron Parish, Louisiana. TransCameron Pipeline requests authorization to construct, install, and operate certain natural gas pipeline facilities also in Cameron Parish, Louisiana. The new liquefaction facilities would have a peak production capacity of 12 million metric tons of liquefied natural gas (LNG) per annum.
The final EIS assesses the potential environmental effects of construction and operation of the Calcasieu Pass Project in accordance with the requirements of the National Environmental Policy Act. The FERC staff concludes that approval of the proposed project, with the mitigation measures recommended in the EIS, would have some adverse environmental impact; however, all of these impacts would be reduced to less-than-significant levels.
The U.S. Army Corps of Engineers, U.S. Coast Guard, U.S. Department of Energy, U.S. Environmental Protection Agency, and U.S. Department of Transportation participated as cooperating agencies in the preparation of the EIS. Cooperating agencies have jurisdiction by law or special expertise with respect to resources potentially affected by a proposal and participate in the National Environmental Policy Act analysis. Although the cooperating agencies provided input on the conclusions and recommendations presented in the final EIS, the agencies will present their own conclusions and recommendations in their respective Records of Decision for the project.
The final EIS addresses the potential environmental effects of the construction and operation of the following project facilities:
• Nine integrated pre-cooled single mixed refrigerant (SMR) blocks;
• two full-containment aboveground LNG storage tanks, each with a usable capacity of approximately 200,000 cubic meters;
• a 1,500-foot by 3,000-foot turning basin adjacent to the Calcasieu River Ship Channel;
• two LNG berthing docks, each designed to handle carriers of 120,000 to 210,000 cubic meter cargo capacity;
• a 720 megawatt natural gas-fired combined cycle gas turbine electric generation facility;
• approximately 23.4 miles of 42-inch-diameter pipeline to bring feed gas from interconnections with ANR Pipeline Company, Texas Eastern Transmission, LP, and Bridgeline Holdings, LP to the terminal site;
• one meter station;
• three mainline valves; and
• one pig launcher at the meter station and one pig receiver at the gas gate station on the terminal site.
The Commission staff mailed a copy of the
Additional information about the project is available from the Commission's Office of External Affairs, at (866) 208-FERC, or on the FERC website (
In addition, the Commission offers a free service called eSubscription that allows you to keep track of all formal issuances and submittals in specific dockets. This can reduce the amount of time you spend researching proceedings by automatically providing you with notification of these filings, document summaries, and direct links to the documents. Go to
Environmental Protection Agency (EPA).
Notice of availability; request for comment.
The Environmental Protection Agency (EPA) is providing notice of a proposed program revision to transfer the authority to implement and enforce the North Dakota Pollutant Discharge Elimination System (NDPDES) program from the North Dakota Department of Health (NDDOH) to the newly established North Dakota Department of Environmental Quality (NDDEQ). If approved, the NDDEQ will administer the approved NDPDES program regulating discharges of pollutants into waters of the United States under its jurisdiction as described in the state's program application. The EPA will retain the authority to issue NPDES permits for facilities located in Indian country and/or discharging to waters in Indian country.
Written comments and/or requests for a public hearing must be received on or before November 29, 2018.
Submit your comments, identified by Docket ID No. EPA-R08-OAR-2018-0389, to the Federal Rulemaking Portal:
VelRey Lozano, U.S. Environmental Protection Agency, Region 8, (8WP-CWW), 1595 Wynkoop Street, Denver, Colorado 80202-1129, 303-312-6128, email
On April 7, 2017, the Governor of North Dakota signed a bill into law mandating the creation of a new North Dakota Department of Environmental Quality. NDDEQ will be a cabinet-level agency that will implement all of the federally authorized or delegated environmental programs currently run by the Environmental Health Section of NDDOH. The law gives NDDOH until July 1, 2019, to obtain the necessary program authorizations and approvals from EPA to allow NDDEQ to implement the State's delegated and/or authorized environmental programs.
A state may revise its NPDES program. 40 CFR 123.62(a). In doing so, the State must submit a modified program description, Attorney General's statement, Memorandum of Agreement or other such documentation as EPA determines to be necessary under the circumstances. 40 CFR 123.62(b). States with approved programs are required to notify EPA whenever they propose to transfer all or part of the approved State agency to any other State agency and to identify any new division of responsibilities amongst the agencies involved. 40 CFR 123.62(c). Organizational charts required in the State's original authorization package must be revised and resubmitted.
On July 30, 2018, the EPA received a complete program revision package from the state of North Dakota. The EPA has determined the program revision package contains all the required elements. The full program revision package is available for inspection and copying at the addresses appearing in the
Entities potentially affected by this action are: The EPA; and the regulated community and residents within the state of North Dakota (see Table 1). This table is not intended to be exhaustive; rather, it provides a guide for readers regarding entities that this action is likely to affect.
If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under
With this action, the EPA is providing notice of a proposed program revision to the State of North Dakota's approved NPDES program to transfer authority to administer the NDPDES program from the NDDOH to the NDDEQ. This action is not changing the current scope of North Dakota's NDPDES program and is transferring authority to another agency to implement the state's current NPDES program as part of the larger effort to move all federally authorized or delegated environmental programs from the NDDOH to the NDDEQ. If the proposed program revision is approved, EPA will retain the authority to issue permits for facilities located in Indian country
This action is taken under the authority of section 402 of the Clean Water Act as amended, 33 U.S.C. 1342. Under 40 CFR 123.62(b)(2), the EPA is required to determine whether proposed program revisions are substantial and, if so, issue public notice and provide an opportunity to comment for a period of at least 30 days. The EPA considers this transfer of state authority to be substantial.
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), NESHAP for Chemical Recovery Combustion Sources at Kraft, Soda, Sulfite, and Stand-Alone Semichemical Pulp Mill (EPA ICR Number 1805.10, OMB Control Number 2060-0377), to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a request for approval of a new collection. Public comments were previously requested via the
Additional comments may be submitted on or before November 29, 2018.
Submit your comments, referencing Docket ID Number EPA-HQ-OECA-2014-0061, to: (1) EPA online using
The EPA's policy is that all comments received will be included in the public docket without change including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI), or other information whose disclosure is restricted by statute.
Patrick Yellin, Monitoring, Assistance, and Media Programs Division, Office of Compliance, Mail Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone number: (202) 564-2970; fax number: (202) 564-0050; email address:
Supporting documents, which explain in detail the information that the EPA will be collecting, are available in the public docket for this ICR. The docket
Federal Deposit Insurance Corporation (FDIC).
Notice and request for comment.
The FDIC, as part of its obligations under the Paperwork Reduction Act of 1995 (PRA), invites the general public and other Federal agencies to take this opportunity to comment on the renewal of the existing information collections described below (3064-0121 and 3064-0135). On August 20, 2018, the FDIC requested comment for 60 days on a proposal to renew the information collections described below. No comments were received. The FDIC hereby gives notice of its plan to submit to OMB a request to approve the renewal of these information collections, and again invites comment on these renewals.
Comments must be submitted on or before November 29, 2018.
Interested parties are invited to submit written comments to the FDIC by any of the following methods:
•
•
•
•
All comments should refer to the relevant OMB control number. A copy of the comments may also be submitted to the OMB desk officer for the FDIC: Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Washington, DC 20503.
Manny Cabeza, Counsel, 202-898-3767,
On August 20, 2018, the FDIC requested comment for 60 days on a proposal to renew the information collections described below. No comments were received. The FDIC hereby gives notice of its plan to submit to OMB a request to approve the renewal of these collections, and again invites comment on these renewals.
1.
2.
The number of PECs completed each year has been declining since 2009. If this trend were to continue, the number of respondents would be expected to continue to decrease from 369 over the next three years, which would imply that the estimated number of respondents should be lower for this collection compared to the one in 2015. The SMEs have acknowledged that 600 respondents may be a conservative estimate, but also believe that it is reasonable. This rationale stems from the fact that the current rate of bank failures is very low. The SMEs also point out that the PECs are collected from prospective purchasers and not just the winning bidders. As a result, the annual number of PECs could increase if there is an increase in the demand for the assets the FDIC sells even if the number of assets for sale decreases in line with the current trend of diminishing bank failures.
The estimated hourly burden for this information collection is 30 minutes per PEC form. The SMEs have arrived at this estimate through their personal observations of individuals completing these forms at open-outcry auction events. The table below contains estimates for the total estimated reporting burden for this information collection.
Comments are invited on: (a) Whether the collection of information is necessary for the proper performance of the FDIC's functions, including whether the information has practical utility; (b) the accuracy of the estimates of the burden of the information collection, including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. All comments will become a matter of public record.
The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841
The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The applications will also be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States.
Unless otherwise noted, comments regarding each of these applications
1.
1.
The companies listed in this notice have applied to the Board for approval, pursuant to the Home Owners' Loan Act (12 U.S.C. 1461
The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The application also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the HOLA (12 U.S.C. 1467a(e)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 10(c)(4)(B) of the HOLA (12 U.S.C. 1467a(c)(4)(B)). Unless otherwise noted, nonbanking activities will be conducted throughout the United States.
Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than November 27, 2018.
A. Federal Reserve Bank of Philadelphia (William Spaniel, Senior Vice President) 100 North 6th Street, Philadelphia, Pennsylvania 19105-1521. Comments can also be sent electronically to
1.
Centers for Medicare & Medicaid Services, HHS.
Notice of Performance Review Board Membership.
Kathy Vaughn, 410-786-1050 or
5 U.S.C. 4314(c)(1) through (5) requires each agency to establish, in accordance with regulations prescribed by the Office of Personnel Management, one or more Senior Executive Service (SES) Performance Review Boards.
The PRB shall review and evaluate the initial summary rating of a senior executive's performance, the executive's response, and the higher-level official's comments on the initial summary rating. In addition, the PRB will review and recommend executive performance bonuses and pay increases.
5 U.S.C. 4314(c)(4) requires the appointment of board members to be published in the
Centers for Medicare and Medicaid Services (CMS), HHS.
Notice with request for comment.
This proposed notice acknowledges the receipt of an application from the American Association for Accreditation of Ambulatory Surgery Facilities, Inc. (AAAASF) for continued recognition as a national accrediting organization (AO) for clinics, rehabilitation agencies, or public health agencies that furnish outpatient physical therapy and speech language pathology services that wish to participate in the Medicare or Medicaid programs.
To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on November 29, 2018.
In commenting, please refer to file code CMS-3369-PN. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.
Comments, including mass comment submissions, must be submitted in one of the following three ways (please choose only one of the ways listed):
1.
2.
Please allow sufficient time for mailed comments to be received before the close of the comment period.
3.
For information on viewing public comments, see the beginning of the
Erin McCoy, (410) 786-2337, Monda Shaver, (410) 786-3410, or Renee Henry, (410) 786-7828.
Under section 1861(p) of the Medicare statute, eligible beneficiaries may receive outpatient physical therapy and speech language pathology (OPT) services from a provider of services, a clinic, rehabilitation agency, a public health agency, or others, provided certain requirements are met. Section 1832(a)(2)(C) of the Social Security Act (the Act) permits payment for OPT services. Regulations concerning provider agreements are at 42 CFR part 489 and those pertaining to activities relating to the survey and certification of facilities are at 42 CFR part 488. The regulations at 42 CFR part 485 subpart H specify the conditions that a clinic, rehabilitation agency or public health agency (“OPT providers”) must meet in order to participate in the Medicare program, the scope of covered services, and the conditions for Medicare payment for OPT providers.
Generally, to enter into an agreement, an OPT provider must first be certified by a State survey agency as complying with the conditions of participation set forth in part 485, subpart H of our Medicare regulations. Thereafter, the OPT provider is subject to regular surveys by a State survey agency to determine whether it continues to meet these requirements.
Section 1865(a)(1) of the Act provides that, if a provider entity demonstrates through accreditation by a Centers for Medicare & Medicaid Services (CMS) approved national accrediting organization (AO) that all applicable Medicare conditions are met or exceeded, we may deem those provider entities as having met the requirements. Accreditation by an AO is voluntary and is not required for Medicare participation.
If an AO is recognized by the Secretary of the Department of Health and Human Services as having standards for accreditation that meet or exceed Medicare requirements, any provider entity accredited by the national accrediting body's approved program may be deemed to meet the Medicare conditions. An AO applying for approval of its accreditation program under part 488, subpart A, must provide CMS with reasonable assurance that the AO requires the accredited provider entities to meet requirements that are at least as stringent as the Medicare conditions. Our regulations concerning the approval of AOs are set forth at § 488.5.
AAAASF's current term of approval for its OPT provider accreditation program expires April 4, 2019.
Section 1865(a)(2) of the Act and our regulations at § 488.5 require that our findings concerning review and approval of an AO's requirements consider, among other factors, the applying AO's requirements for accreditation; survey procedures; resources for conducting required surveys; capacity to furnish information for use in enforcement activities; monitoring procedures for provider entities found not in compliance with the conditions or requirements; and ability to provide CMS with the necessary data for validation.
Section 1865(a)(3)(A) of the Act further requires that we publish, within 60 days of receipt of an organization's complete application, a notice identifying the national accrediting body making the request, describing the nature of the request, and providing at least a 30-day public comment period. We have 210 days from the receipt of a complete application to publish notice of approval or denial of the application.
The purpose of this proposed notice is to inform the public of AAAASF's request for continued CMS approval of its OPT provider accreditation program. This proposed notice also solicits public comment on whether AAAASF's requirements meet or exceed the Medicare conditions of participation (CoPs) for OPT providers.
AAAASF submitted all the necessary materials to enable us to make a determination concerning its request for continued CMS-approval of its OPT provider accreditation program. This application was determined to be complete on September 6, 2018. Under Section 1865(a)(2) of the Act and our regulations at § 488.5, our review and evaluation of AAAASF will be conducted in accordance with, but not necessarily limited to, the following factors:
• The equivalency of AAAASF's standards for OPT providers as compared with Medicare's CoPs for OPT providers.
• AAAASF's survey process to determine the following:
++ The composition of the survey team, surveyor qualifications, and the ability of the organization to provide continuing surveyor training.
++ The comparability of AAAASF's processes to those of State agencies, including survey frequency, and the ability to investigate and respond appropriately to complaints against accredited facilities.
++ AAAASF's processes and procedures for monitoring an OPT provider found out of compliance with AAAASF's program requirements. These monitoring procedures are used only when AAAASF identifies noncompliance. If noncompliance is identified through validation reviews or complaint surveys, the State survey agency monitors corrections as specified at § 488.9(c)(1).
++ AAAASF's capacity to report deficiencies to the surveyed facilities and respond to the facility's plan of correction in a timely manner.
++ AAAASF's capacity to provide CMS with electronic data and reports necessary for effective validation and assessment of the organization's survey process.
++ The adequacy of AAAASF's staff and other resources, and its financial viability.
++ AAAASF's capacity to adequately fund required surveys.
++ AAAASF's policies with respect to whether surveys are announced or unannounced, to assure that surveys are unannounced.
++ AAAASF's agreement to provide CMS with a copy of the most current accreditation survey together with any other information related to the survey as CMS may require (including corrective action plans).
This document does not impose information collection requirements, that is, reporting, recordkeeping or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Because of the large number of public comments we normally receive on
Upon completion of our evaluation, including evaluation of comments received as a result of this proposed notice, we will publish a final notice in the
Food and Drug Administration, HHS.
Notice; establishment of docket; request for comments.
The Food and Drug Administration (FDA or Agency) is announcing the establishment of a public docket to receive suggestions and comments from interested parties (including academic institutions, regulated industry, and patient groups) on the Agency's publication of the surrogate endpoint table (SE table). FDA has developed a web page, available at
Submit either electronic or written comments on this notice by December 31, 2018.
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before December 31, 2018. The
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Christopher Leptak, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6461, Silver Spring, MD 20993-0002, 301-796-0017,
Section 3011 of the 21st Century Cures Act established section 507 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 357), which mandates that FDA publish a list of surrogate endpoints used as a basis to approve or license a drug or biological product under both accelerated and traditional approval provisions. The SE table fulfills this legislative requirement and is intended to provide valuable information for drug developers on endpoints that may be considered and discussed with FDA for individual development programs. FDA refers the public to the following web page for additional background information as well as the SE table:
Section 507(e)(9) of the FD&C Act defines the term “surrogate endpoint” to mean a marker,
This SE table includes SEs that sponsors have used as primary efficacy clinical trial endpoints for approval of new drug applications (NDAs) or biologics license applications (BLAs). The table also includes SEs that may be appropriate for use as a primary efficacy clinical trial endpoint for drug or biologic approval, although the SEs have not necessarily been used to support an approved NDA or BLA. FDA believes that this table should facilitate discussions of potential SEs by sponsors when developers are designing their drug development programs.
To help FDA determine the utility of the SE table, develop future iterations of the SE table, and identify best methods for conveying this information on FDA's website, FDA is soliciting public suggestions and comments on the SE table listed on the following web page:
Specifically, FDA welcomes comments concerning: (1) The utility of the SE table; (2) suggestions on SEs that may not be reflected on the current SE table but that have been used for drug or biologic approvals; (3) the best approach for developing future iterations of the table, and (4) SE table questions you would like FDA to address in future communications. As required by section 507(c)(1) of the FD&C Act, FDA will update this table on the website every 6 months. The Agency will consider comments submitted to the docket as it revises the SE table.
Food and Drug Administration, HHS.
Notice; request for comments.
The Food and Drug Administration (FDA or we) invites data and other information on the prevalence and severity of sesame allergies in the United States and the prevalence of sesame-containing foods sold in the United States that are not required to disclose sesame as an ingredient. We are taking this action to inform possible regulatory action on sesame to protect and promote the public health.
Submit either electronic or written comments on this document by December 31, 2018.
You may submit comments as follows. Electronic comments must be submitted on or before December 31, 2018. The
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
Received comments, those filed in a timely manner (see
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” We will review this copy, including the claimed confidential information, in our consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Carol D'Lima, Office of Nutrition and Food Labeling, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2033.
Food allergies occur when the body's immune system reacts to certain food proteins (Ref. 1). Allergic reactions to food due to immunoglobulin E (IgE) antibodies cause the body to release inflammatory chemicals and can be particularly severe, leading to symptoms such as hives, facial swelling, vomiting, wheezing, shock, and even death. Because there is no cure for food allergies, allergic consumers must use avoidance to prevent allergic reactions. Successful avoidance requires, among other things, that allergic consumers and their caregivers can read and understand the relevant information on packaged food labels and can identify food allergens in other settings, such as at retail or food service establishments.
The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that a food (other than a raw agricultural commodity) that bears or contains a “major food allergen” declare the allergen using its “common or usual name.” A food is misbranded if it contains a major food allergen and fails to declare that major food allergen on its label using the major food allergen's common or usual name (section 403(w) of the FD&C Act). The FD&C Act defines a “major food allergen,” in part, as any of the following:
• Milk,
• Eggs,
• Fish (
• Crustacean shellfish (
• Tree nuts (
• Wheat,
• Peanuts, and
• Soybeans.
See section 201(qq)(1) of the FD&C Act (21 U.S.C. 321(qq)(1)). When Congress amended the FD&C Act regarding food allergens in 2004, these eight foods and food groups, out of more than 160 identified food allergens, accounted for 90 percent of serious food allergic reactions. We issued guidance in 2006 to help the public understand our implementation of the amendments, including what foods and manufacturers are subject to the amendments and labeling requirements (Ref. 2). We issued another guidance in 2014 to clarify the information we need when considering whether to exempt certain ingredients derived from major food allergens from the allergen labeling requirements (Ref. 3). These statutory requirements with respect to a label or labeling for major food allergens do not alter the authority of the Secretary of Health and Human Services under the FD&C Act to require a label or labeling for other food allergens (21 U.S.C. 343 note).
A common or usual name must accurately identify or describe, in as simple and direct terms as possible, the basic nature of the food or its characterizing properties or ingredients and can either be the name established by common use or the name required by a regulation (21 CFR 102.5). In addition to the specific requirement for allergen labeling, any food is misbranded unless its label uses: (1) The common or usual name of the food, if it has one, and (2) the common or usual name of each ingredient, if the food is made from two or more ingredients (section 403(i) of the FD&C Act). Thus, the FD&C Act includes other authorities that assist consumers with a food allergy or other reason for avoiding an ingredient. For example, the label of a food made with sugar must declare this ingredient by its common or usual name—“sugar”—rather than the chemical name “sucrose” (see section 403(i) of the FD&C Act (21 U.S.C. 343(i))).
In addition, section 403(x) of the FD&C Act gives us the authority to issue regulations requiring the disclosure of spices, flavorings, colorings, and incidental additives that are, or contain, allergens other than the eight major food allergens. We relied on this authority, in part, to require the labeling of carmine and cochineal in foods (see 74 FR 207).
In 2014, the Center for Science in the Public Interest, several medical professionals, and two consumer advocacy groups submitted a citizen petition (Ref. 4) requesting, in part, that we issue a rule to require that sesame seeds and sesame products be regulated in a manner similar to the manner in which major food allergens are regulated under the FD&C Act, and specifically to require sesame's disclosure by the common or usual name “sesame” in food labeling. The petition noted, among other things, that the European Union, Canada, Australia, and New Zealand require labeling of
We are interested in learning more about the prevalence and severity of sesame allergies in the United States, and the prevalence of sesame-containing foods sold in the United States that are not required to disclose sesame as an ingredient. We will consider the data and other information submitted, along with previously submitted information, to inform possible steps on sesame as an allergen in food to protect and promote the public health.
We invite comment, particularly scientific data and other evidence, about the following topics:
1. What is the prevalence of IgE-mediated sesame food allergies in the United States? Please provide any studies or data that support your conclusion, and provide your unit of measure (
2. How does the prevalence of IgE-mediated sesame food allergies in the United States compare to the prevalence of IgE-mediated allergies to the major food allergens? Please provide any studies or data that support your conclusion.
3. What proportion of allergic reactions in the United States may be attributed specifically to exposure to undeclared sesame? Please provide any studies or data that support your conclusion.
4. What proportion of allergic reactions to undeclared sesame occur in response to sesame found in packaged food products versus sesame found in foods served at retail or food service establishments (
5. In packaged food products, what proportion of allergic reactions to sesame is due to:
a. Sesame in generically listed spices, flavorings, colorings, or incidental additives;
b. Sesame used as an ingredient and listed by some other name (
c. Cross-contact?
1. What are examples of products or product categories that contain sesame as a spice, flavor, color, or incidental additive and that do not list “sesame” on the product labeling?
2. What amount or concentration of sesame is in products or product categories that contain sesame as a spice, flavor, color, or incidental additive and that do not list “sesame” on the product labeling? Please provide a unit of measure (
3. What are examples of products or product categories other than “spices” that contain sesame in one of the listed ingredients, but the common or usual name of that ingredient does not list “sesame,” specifically, on the product labeling? Please provide a copy of the labeling, if available.
4. What amount or concentration of sesame is in products or product categories that contain sesame in one of the listed ingredients, but the common or usual name of that ingredient does not list “sesame,” specifically, on the product labeling? Please provide a unit of measure (
5. What are examples of food products or product categories in which sesame has been found in a product because of cross-contact?
6. What amount or concentration of sesame has been found in products or product categories that contain sesame because of cross-contact? Please provide a unit of measure (
1. What would the costs be if we established disclosure requirements for sesame? We are interested in any costs, specifically those to manufacturers for labeling changes to reflect sesame as an ingredient, spice, flavor, color, or incidental additive.
2. What would the costs be to manufacturers to control allergen cross-contact from sesame and what would the costs be of educating food managers at retail or food establishments to control for sesame as an allergen?
3. What steps have manufacturers taken to eliminate or reduce cross-contact from sesame and/or sesame-containing ingredients?
The following references are on display at the Dockets Management Staff (see
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled “Considerations for the Development of Dried Plasma Products Intended for Transfusion; Draft Guidance for Industry.” This guidance is intended to assist manufacturers, sponsors, and applicants developing dried plasma products intended for transfusion in order to facilitate the availability of safe and effective dried plasma products in the United States. The draft guidance document provides considerations for the successful development and licensing of dried plasma products and for the approval of devices used to manufacture dried plasma. The guidance includes recommendations on optimal sources of input plasma; manufacturing and product quality, including product characterization; packaging and reconstitution; clinical studies; and device submissions.
Submit either electronic or written comments on the draft guidance by January 28, 2019 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
You may submit comments on any guidance at any time as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).
Submit written requests for single copies of the draft guidance to the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist the office in processing your requests. The draft guidance may also be obtained by mail by calling CBER at 1-800-835-4709 or 240-402-8010. See the
Jonathan McKnight, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.
FDA is announcing the availability of a draft document entitled “Considerations for the Development of Dried Plasma Products Intended for Transfusion; Draft Guidance for Industry.” Plasma is a critical component of early transfusion therapy in the management of traumatic hemorrhage. Plasma can replenish various coagulation proteins that are consumed during the coagulopathy that can accompany traumatic injury. Because plasma products intended for transfusion such as fresh frozen plasma (FFP), plasma frozen within 24 hours after phlebotomy (PF24), and plasma frozen within 24 hours after phlebotomy held at room temperature up to 24 hours after phlebotomy (PF24, RT24) are stored frozen, these products need to be thawed prior to transfusion. This limits
Recent clinical studies have demonstrated promising efficacy and safety of dried plasma, particularly in military applications, and dried plasma products are available for limited use in Germany, South Africa, and France. This guidance is intended to assist manufacturers, sponsors, and applicants developing dried plasma products intended for transfusion in order to facilitate the availability of safe and effective dried plasma products in the United States.
This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on considerations for the development of dried plasma products intended for transfusion. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.
This draft guidance refers to previously approved collections of information subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 211 have been approved under OMB control number 0910-0139; the collections of information in 21 CFR part 312 have been approved under OMB control number 0910-0014; the collections of information in 21 CFR part 601 have been approved under OMB control number 0910-0338; the collections of information in 21 CFR part 610 have been approved under OMB control numbers 0910-0116, 0910-0139, and 0910-0338; the collections of information in 21 CFR part 630 have been approved under OMB control number 0910-0116; the collections of information in 21 CFR part 640 have been approved under OMB control number 0910-0116; the collections of information in 21 CFR part 812 have been approved under OMB control number 0910-0078; and the collections of information in 21 CFR part 814 have been approved under OMB control number 0910-0231.
Persons with access to the internet may obtain the draft guidance at either
Food and Drug Administration, HHS.
Notice.
The Chief Scientist is denying a request for a hearing regarding the proposal by the Center for Drug Evaluation and Research (CDER) of the Food and Drug Administration (FDA or Agency) to refuse to approve a new drug application submitted by Pharmaceutical Manufacturing Research Services, Inc. (PMRS) for oxycodone hydrochloride (HCl) immediate-release (IR) capsules, 5 milligrams (mg), 15 mg, and 30 mg in its present form. The Chief Scientist denies approval.
The order is applicable October 30, 2018.
Nathan R. Sabel, Office of Scientific Integrity, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4206, Silver Spring, MD 20993, 301-796-8588.
PMRS submitted new drug application (NDA) 209155 for oxycodone HCl IR capsules, 5 mg, 15 mg, and 30 mg, under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(b)(2)), relying in part on the Agency's previous findings of safety and effectiveness for ROXICODONE (oxycodone HCl IR tablets (NDA 021011)) (Ref. 1).
PMRS's product contains excipients, including a dye blend, that have solubility in common solvents, including water and ethanol, similar to the solubility of the active pharmaceutical ingredient (API). PMRS contends that a solution prepared from its product for subcutaneous or intravenous injection will look relatively “impure” compared to a solution prepared from Roxicodone and will have a dark, opaque, “contaminated-looking” appearance, providing both a “visual deterrent” and a “chemical deterrent” to abuse by injection (Refs. 2 and 3).
PMRS also provided in vitro data intended to demonstrate that its product would be more difficult to grind into particle sizes suitable for snorting compared to ROXICODONE but provided no data from studies in human subjects to evaluate the pharmacokinetic or pharmacodynamic properties of the product following abuse via the nasal route (Ref. 1).
On November 16, 2017, CDER issued a complete response letter to PMRS under § 314.110(a) (21 CFR 314.110(a)) stating that the NDA could not be
(1) The application in its present form is not approvable with the proposed labeling describing abuse-deterrent properties, for multiple reasons. In particular, (a) the oxycodone in the formulation can be readily extracted in commonly available solvents into a solution suitable for injection; (b) there were insufficient data showing the presence of excipients (including dye) in the formulation can be expected to deter abuse by injection; (c) the data submitted were insufficient to show the product was meaningfully resistant to manipulation for misuse or abuse; and (d) there were not data submitted, including data from pharmacokinetic and human abuse liability studies, fully characterizing the product's abuse potential by all relevant routes of abuse. Also, the data submitted were not sufficient to rule out the possibility that the proposed formulation could result in a greater proportion of abuse by injection of PMRS's product compared to a conventional oxycodone IR formulation. Abuse by injection carries greater risk of overdose and transmission of infectious disease than abuse by other routes.
(2) The safety and purity of the excipients intended (but not shown) to confer abuse-deterrent properties were not adequately characterized, either by the intended oral route of use or by expected routes of abuse, including injection.
(3) An overall evaluation of elemental impurities in the final formulation and a risk assessment for each heavy metal (taking into consideration the maximum daily dose) were not provided.
(4) The application did not fully comply with the patent certification requirements applicable to applications submitted under section 505(b)(2) of the FD&C Act.
The complete response letter describes additional deficiencies relating to the chemistry, manufacturing, and controls (CMCs) and current good manufacturing practice requirements that CDER determined precluded approval of the application in its present form (Ref. 5). The complete response letter also noted that satisfactory resolution of objectionable inspection observations was required before the application could be approved (Ref. 5).
In response to the complete response letter, on November 17, 2017, PMRS submitted a request for an opportunity for hearing under § 314.110(b)(3) on whether there are grounds under section 505(d) of the FD&C Act for denying approval of the NDA.
On February 13, 2018, FDA published a notice of opportunity for a hearing (NOOH) setting forth CDER's proposal to refuse to approve PMRS's NDA for oxycodone HCl IR capsules in 5-mg, 15-mg, and 30-mg strengths (83 FR 6196). The NOOH stated that, for the reasons described above and others described in the complete response letter, notice is given to PMRS and to all other interested persons that FDA proposes to issue an order refusing to approve the NDA because the application fails to meet the criteria for approval under section 505(d) of the FD&C Act, including that: (1) PMRS has not provided sufficient data to show that the product would be safe (section 505(d)(1)); (2) PMRS has not shown that the methods used in, and the facilities and controls used for, the manufacture, processing, or packing of the product are adequate to preserve its identity, strength, quality, and purity (section 505(d)(3)); and (3) the labeling PMRS proposed for the product is false or misleading (section 505(d)(7)).
PMRS submitted a request for a hearing on February 15, 2018. PMRS also submitted data, information, and analysis in support of its hearing request on April 13, 2018 (April Submission).
Under § 12.24(a)(2) (21 CFR 12.24(a)(2)), the Agency reviews a hearing request to determine whether a hearing has been justified. FDA has the authority to deny a hearing when it appears from the hearing request that there are no material disputes of fact. See
In determining whether there are material issues of fact suitable for a hearing, FDA considers the specific criteria set out in § 12.24(b) and grants a hearing only if the material submitted in support of the request shows the following: (1) There is a genuine and substantial factual issue for resolution at a hearing; a hearing will not be granted on issues of policy or law;
Following review of the administrative record related to this proceeding, the Chief Scientist
Among other bases for proposing to deny PMRS's NDA, the NOOH cites the requirement that FDA deny approval to applications that propose labeling that is false or misleading in any particular (see section 505(d)(7) of the FD&C Act; 21 CFR 314.125(b)(6)). On this basis, the November 16, 2017, complete response letter explained that the NDA in its current form is not approvable with the proposed labeling describing abuse-deterrent properties. PMRS proposed labeling that includes multiple statements that the product has properties that make it more difficult to manipulate for purposes of abuse and misuse than a conventional formulation (Ref. 6). These statements include the assertion that the product “is formulated with inactive ingredients that make the capsule more difficult to manipulate for misuse and abuse” and that “the results of this testing demonstrated that [the product] capsules, in comparison to Roxicodone tablets, have increased resistance to physical and chemical extraction.” (Ref. 6).
Specifically, the complete response letter explained that PMRS submitted “[n]o data . . . to support the proposed hypothesis that the presence of excipients or dye in the solution would create a deterrence to intravenous abuse” (Ref. 5). Generally, PMRS's hypothesis is that commonly used methods of preparing a solution for injection, if applied to its product, will result in a solution that will look “visually unappealing” compared to a solution prepared from Roxicodone, and will have a dark, opaque, “contaminated-looking” appearance that will serve as a “visual deterrent” to abuse (Ref. 2). PMRS's NDA provided in vitro data intended to show that a solution prepared for injection would have such an appearance (Refs. 2 and 3).
As CDER informed PMRS during the application process, CDER considered this in vitro data unable to prove that PMRS's hypothesis is correct that individuals would actually be deterred by the appearance of a solution prepared from this formulation (Ref. 8). Although a solution prepared from PMRS's product may appear a certain way based on the in vitro data provided, PMRS has produced no scientific data or information to establish that people who inject opioids would be less likely to do so because of this appearance or based upon knowledge that the solution contains other components of the drug product in addition to the API. To demonstrate that this formulation deters abuse, and thus to support the proposed labeling for abuse-deterrent properties, CDER asked PMRS to provide evidence sufficient to prove that people who abuse opioids by injection would be deterred from doing so based on the solution's appearance.
“At this time, we are not aware of data that support a deterrent effect based on the presence of a dye in a formulation intended to be abuse-deterrent. Provide evidence that supports the concept that the incorporation of a dye into a formulation imparts abuse-deterrent effects to that formulation. A hypothetical argument that the presence of a dye will provide an abuse-deterrent effect is not sufficient to support labeling.” (Ref. 8).
Critically, however, PMRS's NDA and subsequent submissions in this proceeding contain no such data or information on this critical question, either from PMRS's studies of its own product or from any potentially relevant scientific literature. In lieu of scientifically valid evidence for the proposition that appearance deters abuse, PMRS simply reiterates how the solution appears. PMRS states, variously, that the “dark, significant color is visually unappealing for potential intravenous abuse” (Ref. 2); that “PMRS considers this visual deterrent effective in classifying drug products as abuse deterrent” (id.); that “[t]he use of an FD&C dye was considered a deterrent to abuse as it
PMRS has also failed to offer evidence to establish its proposed conclusion related to another deficiency cited in the complete response letter (Ref. 5), specifically, PMRS's failure to establish that its product formulation deters abuse by snorting. Despite CDER's requests that human testing be conducted to establish whether this formulation deters abuse by snorting (see Refs. 5 and 8), PMRS declined to conduct such testing or to provide any other information to show that its product functions to deter abuse by snorting. Without human testing, or other appropriate data and information, it is not possible to evaluate whether PMRS's formulation has properties that render it more or less likely to be snorted.
The Chief Scientist concludes that PMRS has not created a genuine and substantial issue of fact justifying a hearing on this issue. As CDER informed PMRS during the review process and in the complete response letter, PMRS has not provided evidence that demonstrate its product deters abuse. Despite requesting a factual hearing and offering in vitro data intended to demonstrate how its product looks in solution, PMRS has not provided sufficient and reliable data or information that creates a genuine and substantial dispute of fact with respect to whether the appearance of such a solution deters abuse in the manner PMRS proposes to describe in its labeling. PMRS may have submitted evidence to show what the product looks like when prepared for injection but PMRS has not provided no clinical evidence—or indeed any evidence—that this appearance will deter abuse as PMRS's NDA represents in its proposed labeling. In addition, PMRS has failed to provide sufficient evidence to establish that the product formulation deters abuse by snorting. As a result, there exists no contested factual issue with respect to the information available to demonstrate whether PMRS's formulation possesses abuse-deterrent properties. Accordingly, the Chief Scientist denies PMRS's request for a factual hearing on this issue under §§ 12.24(b) and 314.200(g) because there exists no genuine and substantial issue of fact that would require such a hearing to resolve.
Having found that that is no genuine and substantial question of fact with respect to whether PMRS's proposed labeling is false or misleading, the Chief Scientist also finds that the Agency must therefore issue an order refusing to approve PMRS's NDA in its present form under section 505(d)(7) of the FD&C Act.
FDA makes approval decisions, including decisions regarding the content of FDA-approved prescription drug labeling, based on a comprehensive scientific evaluation of the available data and information, allowing only information for which there is a scientific basis to be included.
Against this backdrop, PMRS's unsupported assertions and in vitro data are insufficient to demonstrate that its product formulation will deter abuse. Given the lack of data establishing the effect of PMRS's formulation on its risks of abuse compared to a conventional formulation, the labeling statements PMRS has proposed suggesting that sufficient and reliable evidence exists and establishes that PMRS's formulation deters abuse would be false and misleading. Thus, the proposed labeling
Instead of providing data and information addressing the absence of genuine and substantial issues of fact discussed in the previous sections, the PMRS's submissions consists largely of legal and policy objections to FDA's approach to evaluating, labeling, and approving opioids, as well as requests for the Agency to take specific actions regarding other drug products premised on PMRS's proposed alternative policies regarding opioids. These legal and policy arguments do not raise a genuine and substantial issue of fact justifying a hearing. See § 12.24(b)(1) (“A hearing will not be granted on issues of policy or law.”).
PMRS argues that CDER incorrectly proposed refusing to approve its NDA with the proposed abuse-deterrent labeling because CDER applied what PMRS considers the flawed approach to the evaluation and labeling of abuse-deterrent products contained in FDA's 2015 guidance for industry, “Abuse-Deterrent Opioids—Evaluation and Labeling” (Ref. 14) (the Guidance). Specifically, PMRS argues that the guidance's emphasis on premarket studies (
First, PMRS makes a policy argument that FDA, by following the approach described in the Guidance, routinely approves abuse-deterrent labeling claims that are too strong or overly broad based on premarket data. But this argument does not raise an issue of fact regarding the approvability of an NDA for a product bearing a labeling claim that PMRS characterizes as a “more appropriately limited claim about abuse deterrence” (April Submission at 2). As stated above, PMRS has not presented data, information, or analysis that support a conclusion that its product is approvable with
The Chief Scientist finds PMRS's APA claim similarly irrelevant to the question of whether a hearing should be granted. PMRS contends that, by recommending that PMRS follow the
In sum, the Chief Scientist concludes that PMRS has raised no legal or policy argument that alters the determinations discussed in the previous sections.
In its August Submission, PMRS argues that a Part 12 hearing would be “otherwise in the public interest” within the meaning of § 314.200(g)(6) in order to resolve broader policy issues related to opioid abuse. The Chief Scientist disagrees and finds in her discretion that a Part 12 hearing on this NDA would not otherwise be in the public interest.
As discussed above, PMRS's submissions raise arguments relevant to FDA's regulation of opioid products and to the crisis of opioid abuse, generally. For example, PMRS argues that the “emphasis on so-called abuse-deterrent formulations and labeling in response to the opioid epidemic has resulted in the market entry of additional misbranded products” and that “[s]uch false and misleading labeling serves only to confuse prescribers and patients about what the product is and . . . is not” (April Submission at 4). In its submissions, PMRS also requests that FDA take specific regulatory action regarding several other specific opioid products.
The Agency continues to take a variety of steps to address the public health crisis created by opioid abuse and the resulting addiction and death. For example, in May 2017, the Commissioner of Food and Drugs (the Commissioner) announced the establishment of an Opioid Policy Steering Committee to explore and develop additional approaches or strategies FDA could deploy to combat the opioid crisis.
The Agency is also working to enhance prescriber and patient awareness of the safe use of opioids. In 2017, FDA notified holders of approved applications for IR opioid analgesics of the Agency's determination that a REMS is necessary for IR opioid analgesics to ensure that the benefits of these drugs continue to outweigh the risks. Under this new policy, the IR opioid analgesics that are intended to be used in the outpatient setting will be subject to the same REMS requirements as the Extended-Release/Long-Acting opioid analgesics.
In addition, the Agency is undertaking a study to improve its understanding of prescriber beliefs relating to use of opioid products with abuse-deterrent properties.
As these examples show, the Agency is working to address the crisis of opioid addiction and abuse and recognizes the importance of seeking public comment and participation relevant to FDA's opioid-related policies. However, the Chief Scientist does not believe that a Part 12 hearing on the approvability of PMRS's NDA is an appropriate forum to address such concerns and finds in her discretion that such a hearing would not be in the public interest.
As described above, the Chief Scientist has determined that PMRS has not raised a genuine and substantial issue of fact that would warrant a hearing and that PMRS's proposed labeling containing abuse-deterrent representations would be false and misleading under section 505(d)(7) of the FD&C Act. Although the complete response letter and NOOH describe additional deficiencies in PMRS's NDA, it is not necessary to address these issues in this order because, even if resolved in PMRS's favor, PMRS's NDA would still be refused approval in its present form under section 505(d)(7) of the FD&C Act.
For the reasons described above, the Chief Scientist finds that PMRS has not raised any genuine and substantial issue of fact that would justify a hearing (see §§ 12.24(b)(1) and 314.200(g)(1)). Accordingly, PMRS's request for a hearing is denied. The record conclusively shows that the approval criteria set forth in section 505(d)(7) of the FD&C Act have not been met. Therefore, under section 505(d) of the FD&C Act of the FD&C Act, the Chief Scientist hereby denies approval to PMRS's NDA in its present form.
The following references marked with an asterisk (*) are on display in the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and are available for reviewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at
Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS).
Notice.
The National Advisory Council on Nurse Education and Practice (NACNEP or the Council) has scheduled a public meeting. Information about NACNEP and the agenda for this meeting can be found on the NACNEP website at
November 19, 2018, 8:30 a.m.-4:15 p.m. ET.
This meeting will be held by teleconference and webinar. The conference call-in number is 1-888-455-0640; passcode: HRSA COUNCIL. The webinar link is
Tracy L. Gray, MBA, MS, RN, Division of Nursing and Public Health, Bureau of Health Workforce, HRSA, 5600 Fishers Lane, 11N112, Rockville, Maryland 20857; 301-443-3346; or
NACNEP provides advice and recommendations to the Secretary of Health and Human Services (Secretary) and the U.S. Congress on policy matters arising in the administration of Title VIII of the Public Health Service (PHS) Act, as amended, including the range of issues relating to nurse supply, education, and practice improvements. NACNEP provides an annual report to the Secretary and Congress describing the activities of NACNEP, including findings and recommendations made by NACNEP concerning the activities under this title.
During the November 19, 2018, meeting, NACNEP will continue discussing areas where nursing can take the lead in the transition of the health care system to value-based care through improvements to nurse education and practice, to advance the development of its 15th Report. In addition, the members will discuss strategic priorities and future directions for the Council and discuss possible topics for its 16th Report. Agenda items are subject to change as priorities dictate. Refer to the NACNEP website for any updated information concerning the meeting.
Members of the public will have the opportunity to provide comments. Public participants may submit written statements in advance of the scheduled meeting. Oral comments will be honored in the order they are requested and may be limited as time allows. Requests to make oral comments or provide written statements to NACNEP should be sent to Ms. Tracy L. Gray, Designated Federal Official, using the contact information above at least 3 business days prior to the meeting.
National Institutes of Health, HHS.
Notice.
The invention listed below is jointly owned by an agency of the U.S. Government with Pontificia Universidad Catolica de Chile and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Licensing information and copies of the U.S. patent application listed below may be obtained by communicating with Ami Gadhia, JD, LL.M., CLP, Technology Transfer and Patenting Specialist, National Center for Advancing Translational Sciences, NIH, 9800 Medical Center Drive, Rockville, MD 20850, Phone: 301-217-6098, or email
Technology description follows.
The invention includes compounds that inhibit c-Abl tyrosine kinase, and methods of making them which include administering (i) a therapeutically effective amount of the compound or a stereoisomer, tautomer, pharmaceutically acceptable salt, solvate, or prodrug thereof; or (ii) a therapeutically effective amount of the pharmaceutical compositions to a patient with the disease which involves c-Abl tyrosine kinase, including the overexpression of it. In some embodiments, the compound inhibits c-Abl tyrosine kinase by binding to an allosteric site of the c-Abl tyrosine kinase. In some embodiments, the compound binds to a myristate pocket of the c-Abl tyrosine kinase.
This technology is available for licensing for commercial development in accordance with 35 U.S.C. 209 and 37 CFR part 404, as well as for further
• Novel therapeutics for neurodegenerative diseases AND other indications which involve c-Abl kinase (
• Novel compounds that have a commercial advantage over those currently known because they are able to selectively bind to c-Abl at an allosteric site, can cross the blood-brain barrier, and show robust efficacy in several neurodegenerative models. All of this allows them to potentially treat neurodegenerative diseases, cancer etc.
• Pre-Clinical (in vivo validation).
• Juan Marugan, Marc Ferrer, Noel Southall, Andres Dulcey, Xin Hu, Christopher Dextras, Daniel Talley, Alejandra Alvarez, Silvana Zanlungo.
Licensing Contact: Ami Gadhia, JD, LL.M., CLP, 301-217-6098;
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
Coast Guard, DHS.
Sixty-day notice requesting comments.
In compliance with the Paperwork Reduction Act of 1995, the U.S. Coast Guard intends to submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB), Office of Information and Regulatory Affairs (OIRA), requesting an extension of its approval for the following collection of information: 1625-0088, Voyage Planning for Tank Barge Transits in the Northeast United States. Our ICR describes the information we seek to collect from the public. Before submitting this ICR to OIRA, the Coast Guard is inviting comments as described below.
Comments must reach the Coast Guard on or before December 31, 2018.
You may submit comments identified by Coast Guard docket number [USCG-2018-0879] to the Coast Guard using the Federal eRulemaking Portal at
A copy of the ICR is available through the docket on the internet at
Mr. Anthony Smith, Office of Information Management, telephone 202-475-3532, or fax 202-372-8405, for questions on these documents.
This Notice relies on the authority of the Paperwork Reduction Act of 1995; 44 U.S.C. chapter 35, as amended. An ICR is an application to OIRA seeking the approval, extension, or renewal of a Coast Guard collection of information (Collection). The ICR contains information describing the Collection's purpose, the Collection's likely burden on the affected public, an explanation of the necessity of the Collection, and other important information describing the Collection. There is one ICR for each Collection.
The Coast Guard invites comments on whether this ICR should be granted based on the Collection being necessary for the proper performance of Departmental functions. In particular, the Coast Guard would appreciate comments addressing: (1) The practical utility of the Collection; (2) the accuracy of the estimated burden of the Collection; (3) ways to enhance the quality, utility, and clarity of information subject to the Collection; and (4) ways to minimize the burden of the Collection on respondents, including the use of automated collection techniques or other forms of information technology. In response to your comments, we may revise this ICR or decide not to seek an extension of approval for the Collection. We will consider all comments and material received during the comment period.
We encourage you to respond to this request by submitting comments and related materials. Comments must contain the OMB Control Number of the ICR and the docket number of this request, [USCG-2018-0879], and must be received by December 31, 2018.
We encourage you to submit comments through the Federal eRulemaking Portal at
We accept anonymous comments. All comments received will be posted without change to
The Paperwork Reduction Act of 1995; 44 U.S.C. chapter 35, as amended.
Coast Guard, DHS.
Thirty-day notice requesting comments.
In compliance with the Paperwork Reduction Act of 1995 the U.S. Coast Guard is forwarding an Information Collection Requests (ICR), abstracted below, to the Office of Management and Budget (OMB), Office of Information and Regulatory Affairs (OIRA), requesting an extension of its approval for the following collection of information: 1625-0015, Bridge Permit Application Guide. Our ICR describes the information we seek to collect from the public. Review and comments by OIRA ensure we only impose paperwork burdens commensurate with our performance of duties.
Comments must reach the Coast Guard and OIRA on or before November 29, 2018.
You may submit comments identified by Coast Guard docket number [USCG-2018-0497] to the Coast Guard using the Federal eRulemaking Portal at
(1)
(2)
A copy of the ICR is available through the docket on the internet at
Mr. Anthony Smith, Office of Information Management, telephone 202-475-3532, or fax 202-372-8405, for questions on these documents.
This Notice relies on the authority of the Paperwork Reduction Act of 1995; 44 U.S.C. chapter 35, as amended. An ICR is an application to OIRA seeking the approval, extension, or renewal of a Coast Guard collection of information (Collection). The ICR contains information describing the Collection's purpose, the Collection's likely burden on the affected public, an explanation of the necessity of the Collection, and other important information describing the Collection. There is one ICR for each Collection. The Coast Guard invites comments on whether this ICR should be granted based on the Collection being necessary for the proper performance of Departmental functions. In particular, the Coast Guard would appreciate comments addressing: (1) The practical utility of the Collection; (2) the accuracy of the estimated burden of the Collection; (3) ways to enhance the quality, utility, and clarity of information subject to the Collection; and (4) ways to minimize the burden of the Collection on respondents, including the use of automated collection techniques or other forms of information technology. These comments will help OIRA determine whether to approve the ICR referred to in this Notice.
We encourage you to respond to this request by submitting comments and related materials. Comments to Coast Guard or OIRA must contain the OMB Control Number of the ICR. They must also contain the docket number of this request, [USCG-2018-0497], and must be received by November 29, 2018.
We encourage you to submit comments through the Federal eRulemaking Portal at
We accept anonymous comments. All comments received will be posted without change to
OIRA posts its decisions on ICRs online at
This request provides a 30-day comment period required by OIRA. The Coast Guard published the 60-day notice (83 FR 42522, August 22, 2018) required by 44 U.S.C. 3506(c)(2). That
The Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended.
Bureau of Safety and Environmental Enforcement (BSEE), Interior.
Notice of public meeting.
The Bureau of Safety and Environmental Enforcement (BSEE) is hosting a public meeting to discuss advancement of a low-emission spray combustion unit for responding to oil spills.
This public meeting will be held on December 10, 2018 from 9 to 11 a.m.
The meeting will be held in Room 121 at 1201 Elmwood Park Blvd., New Orleans, LA 70123.
Karen N. Stone, (703) 787-1810 or email
This notice is to inform the interested public that BSEE, Oil Spill Preparedness Division (OSPD), Response Research Branch will be conducting a public meeting to discuss advancement of a low-emission spray combustion unit being designed to burn water-in-oil emissions. System integration including platform/barge configurations will be discussed to ready the unit towards use in oil spill cleanup operations.
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has determined to review the final initial determination (“ID”) in-part and extend the target date for completion of the investigation until January 25, 2019.
Amanda Pitcher Fisherow, Esq., Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436, telephone (202) 205-2737. Copies of non-confidential documents filed in connection with this investigation are or will be available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436, telephone (202) 205-2000. General information concerning the Commission may also be obtained by accessing its internet server at
The Commission instituted this investigation on August 1, 2017, based on a complaint and supplement, filed on behalf of Hologic, Inc. of Marlborough, Massachusetts (“Hologic”). 82 FR 35829-24 (Aug. 1, 2017). The complaint, as supplemented, alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain x-ray breast imaging and components thereof by reason of infringement of certain claims of U.S. Patent No. 7,831,296 (“the '296 patent”); U.S. Patent No. 8,452,379 (“the '379 patent”); U.S. Patent No. 7,688,940 (“the '940 patent”); U.S. Patent No. 7,986,765 (“the '765 patent”); and U.S. Patent No. 7,123,684 (“the '684 patent”). The complaint further alleges that an industry in the United States exists as required by section 337. The Notice of Investigation named FUJIFILM Corporation of Tokyo, Japan; FUJIFILM Medical Systems USA, Inc. of Stamford, Connecticut; and FUJIFILM Techno Products Co., Ltd. of Hanamaki-Shi Iwate, Japan (collectively, “Fujifilm”) as respondents. The Office of Unfair Import Investigations (“OUII”) was named as a party. On January 18, 2018, the '765 patent was terminated in its entirety from the investigation.
On July 26, 2018, the ALJ issued the final ID and found a violation of section 337 has occurred. On August 8, 2018, Fujifilm and OUII each filed petitions for review of the final ID. On August 16, 2018, OUII and Hologic filed responses to the petitions for review.
Having examined the record of this investigation, including the ALJ's final ID, the petitions for review, and the responses thereto, the Commission has determined to review the final ID in part. Specifically, the Commission has determined to review the ID's findings on (1)
In connection with its review, the Commission is interested in responses to the following questions:
1. Was the argument that “conventional mammogram,” as used in the '379 and '296 patents, should be construed to include diagnostic images waived?
2. Does the claimed “dose” for a “conventional mammogram,” as used in the '379 and '296 patents, meet the indefiniteness standard set forth in
3. To what extent are the ID's findings on whether the “dose” for a conventional mammogram has changed over time necessary in establishing whether the “dose” for conventional mammogram is definite/indefinite?
4. Please discuss whether the terms of degree, as used in the asserted claims of '379 and '296 patents, are indefinite. The Commission is interested in evidence that would provide an understanding of the terms to a person of ordinary skill in the art and the relevant case law.
5. The asserted claims of the '379 and '296 patents require a comparison of different x-ray doses and in particular, to a dose used for a conventional mammogram. Does the specification, claims, prosecution history, or extrinsic record shed light on whether the comparison is made to a conventional two-dimensional system or whether the comparison is made to the two-dimensional mode on a device that performs both two-dimensional and three-dimensional imaging?
6. Would claims 1, 2, and 22 of the '940 patent be anticipated by the GE Senographe 2000D System and/or Manual if the Commission were to find that the claims allow for the anti-scatter grid to be completely removed?
The parties are requested to brief only the discrete issues above, with reference to the applicable law and evidentiary record. The parties are not to brief other issues on review, which are adequately presented in the parties' existing filings.
In connection with the final disposition of this investigation, the Commission may (1) issue an order that could result in the exclusion of the subject articles from entry into the United States, and/or (2) issue one or more cease and desist orders that could result in the respondents being required to cease and desist from engaging in unfair acts in the importation and sale of such articles. Accordingly, the Commission is interested in receiving written submissions that address the form of remedy, if any, that should be ordered. If a party seeks exclusion of an article from entry into the United States for purposes other than entry for consumption, the party should so indicate and provide information establishing that activities involving other types of entry either are adversely affecting it or likely to do so. For background, see
If the Commission contemplates some form of remedy, it must consider the effects of that remedy upon the public interest. The factors the Commission will consider include the effect that an exclusion order and/or cease and desist orders would have on (1) the public health and welfare, (2) competitive conditions in the U.S. economy, (3) U.S. production of articles that are like or directly competitive with those that are subject to investigation, and (4) U.S. consumers. The Commission is therefore interested in receiving written submissions that address the aforementioned public interest factors in the context of this investigation.
If the Commission orders some form of remedy, the U.S. Trade Representative, as delegated by the President, has 60 days to approve or disapprove the Commission's action.
The Commission has also determined to extend the target date for completion of this investigation until January 25, 2019.
Please discuss whether the accused Fujifilm products have been proven to be more effective in screening for breast cancer than comparable systems available in the United States (
The written submissions and proposed remedial orders must be filed no later than close of business on November 5, 2018. Reply submissions must be filed no later than the close of business on November 13, 2018. Opening submissions are limited to 75 pages. Reply submissions are limited to 50 pages. No further submissions on any of these issues will be permitted unless otherwise ordered by the Commission.
Persons filing written submissions must file the original document electronically on or before the deadlines stated above and submit eight true paper copies to the Office of the Secretary by noon the next day pursuant to section 210.4(f) Of the Commission's Rules of Practice and Procedure (19 CFR 2.10.4(f)). Submissions should refer to the investigation number (“Inv. No. 337-TA-1063”) in a prominent place on the cover page and/or the first page. (
Any person desiring to submit a document to the Commission in confidence must request confidential treatment. All such requests should be directed to the Secretary to the Commission and must include a full statement of the reasons why the Commission should grant such treatment.
The authority for the Commission's determination is contained in section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and in part 210 of the Commission's Rules of Practice and Procedure (19 CFR part 210).
By order of the Commission.
Notice of application.
Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before November 29, 2018. Such persons may also file a written request for a hearing on the application on or before November 29, 2018.
Written comments should be sent to: Drug Enforcement Administration, Attention: DEA
The Attorney General has delegated his authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Assistant Administrator of the DEA Diversion Control Division (“Assistant Administrator”) pursuant to section 7 of 28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR 1301.34(a), this is notice that on July 16, 2018, Cambrex High Point, Inc., 4180 Mendenhall Oaks Parkway, High Point, North Carolina 27265-8017 applied to be registered as an importer of the following basic class of controlled substance:
The company plans to import the listed controlled substance for clinical trial narcotic material for bulk manufacture.
Notice of registration.
The registrant listed below has applied for and been granted registration by the Drug Enforcement Administration (DEA) as an importer of schedule I or schedule II controlled substances.
The company listed below applied to be registered as an importer of various basic classes of controlled substances. Information on the previously published notice is listed in the table below. No comments or objections were submitted and no requests for hearing were submitted for this notice.
The DEA has considered the factors in 21 U.S.C. 823, 952(a) and 958(a) and determined that the registration of the listed registrant to import the applicable basic classes of schedule I or II controlled substances is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. The DEA investigated the company's maintenance of effective controls against diversion by inspecting and testing the company's physical security systems, verifying the company's compliance with state and local laws, and reviewing the company's background and history.
Therefore, pursuant to 21 U.S.C. 952(a) and 958(a), and in accordance with 21 CFR 1301.34, the DEA has granted a registration as an importer for schedule II controlled substances to the above listed company.
Notice of registration.
Registrants listed below have applied for and been granted registration by the Drug Enforcement Administration (DEA) as bulk manufacturers of various classes of schedule I and II controlled substances.
The companies listed below applied to be registered as bulk manufacturers of various basic classes of controlled substances. Information on previously published notices is listed in the table below. No comments or objections were submitted for these notices.
The DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of these registrants to manufacture the applicable basic classes of controlled substances is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. The DEA investigated each of the company's maintenance of effective controls against diversion by inspecting and testing each company's physical security systems, verifying each company's compliance with state and local laws, and reviewing each company's background and history.
Therefore, pursuant to 21 U.S.C. 823(a), and in accordance with 21 CFR 1301.33, the DEA has granted a registration as a bulk manufacturer to the above listed companies.
Notice of application.
Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before December 31, 2018.
Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152.
The Attorney General has delegated his authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Assistant Administrator of the DEA Diversion Control Division (“Assistant Administrator”) pursuant to section 7 of 28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR 1301.33(a), this is notice that on August 22, 2018, Insys Manufacturing, LLC, 2700 Oakmont Drive, Round Rock, Texas 78665-1019 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances:
The company plans to manufacture bulk synthetic active pharmaceutical ingredients (APIs) for product development and distribution to its customers. No other activity for these drug codes are authorized for this registration.
Notice of application.
Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before November 29, 2018. Such persons may also file a written request for a hearing on the application on or before November 29, 2018.
Written comments should be sent to: Drug Enforcement Administration, Attention: DEA
The Attorney General has delegated his authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Assistant Administrator of the DEA Diversion Control Division (“Assistant Administrator”) pursuant to section 7 of 28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR 1301.34(a), this is notice that on August 17, 2018, United States Pharmacopeial
The company plans to import the bulk controlled substance for distribution of analytical reference standards to its customers for research and analytical purposes.
Notice of application.
Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before November 29, 2018. Such persons may also file a written request for a hearing on the application on or before November 29, 2018.
Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/OALJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152.
The Attorney General has delegated his authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Assistant Administrator of the DEA Diversion Control Division (“Assistant Administrator”) pursuant to section 7 of 28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR 1301.34(a), this is notice that on August 30, 2018, Sharp (Bethlehem), LLC, 2400 Baglyos Circle, Bethlehem, Pennsylvania 18020, applied to be registered as an importer of the following basic class of controlled substances:
The company plans to import dosage forms of the listed controlled substances to conduct clinical trials.
Approval of permit applications will occur only when the registrant's activity is consistent with what is authorized under to 21 U.S.C. 952 (a)(2).
Authorization will not extend to the import of FDA approved or non-approved finished dosage forms for commercial sale.
Notice of application.
Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before November 29, 2018. Such persons may also file a written request for a hearing on the application on or before November 29, 2018.
Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/OALJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152.
The Attorney General has delegated his authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Assistant Administrator of the DEA Diversion Control Division (“Assistant Administrator”) pursuant to section 7 of 28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR 1301.34(a), this is notice that on August 17, 2018, Fisher Clinical Services Inc., 7554 Schantz Road, Allentown, Pennsylvania 18106, applied to be registered as an importer of the following basic classes of controlled substances:
The company plans to import the listed controlled substances for clinical trials.
Notice of application.
Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before December 31, 2018.
Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152.
The Attorney General has delegated his authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been delegated to the Assistant Administrator of the DEA Diversion Control Division (“Assistant Administrator”) pursuant to section 7 of 28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR 1301.33(a), this is notice that on June 14, 2018, Sigma Aldrich Research, 1-3 Strathmore Road, Natick, Massachusetts 01760-2447 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances:
The company plans to manufacture reference standards.
Notice of application.
Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before November 29, 2018. Such persons may also file a written request for a hearing on the application on or before November 29, 2018.
Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/OALJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152.
The Attorney General has delegated his authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Assistant Administrator of the DEA Diversion Control Division (“Assistant Administrator”) pursuant to section 7 of 28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR 1301.34(a), this is notice that on July 17, 2018, Catalent CTS, LLC, 10245 Hickman Mills Drive, Kansas City,
The company plans to import finished dosage unit products containing gamma-hydroxybutryic acid and marihuana extracts for clinical trial studies. These marihuana extracts compounds are listed under drug code 7350. No other activity for these drug codes is authorized for this registration. Approval of permit applications will occur only when the registrant's business activity is consistent with what is authorized under 21 U.S.C. 952(a) (2). Authorization will not extend to the import of FDA-approved or non-approved finished dosage forms for commercial sale.
On February 6, 2018, the Acting Assistant Administrator, Diversion Control Division, Drug Enforcement Administration (hereinafter, DEA or Government), issued an Order to Show Cause to Eric Lee Knight, M.D. (hereinafter, Registrant), of Derry, New Hampshire. Order to Show Cause (hereinafter, OSC), at 1. The OSC proposes the revocation of Registrant's Certificate of Registration on the ground that he does “not have authority to handle controlled substances in the State of New Hampshire, the state in which . . . [he is] registered with the DEA.”
Regarding jurisdiction, the OSC alleges that Registrant holds DEA Certificate of Registration No. BK7282940 at the registered address of 93
The substantive ground for the proceeding, as alleged in the OSC, is that Registrant is “without authority to handle controlled substances in New Hampshire, the state in which [he is] registered with the DEA.”
The OSC notifies Registrant of his right to request a hearing on the allegations or to submit a written statement while waiving his right to a hearing, the procedures for electing each option, and the consequences for failing to elect either option.
In a Declaration dated April 27, 2018, a Diversion Investigator (hereinafter, DI), who describes herself as being assigned to the DEA Boston Field Division-Manchester (New Hampshire) District Office, states that after two unsuccessful attempts at serving the OSC on Registrant, she and two Task Force Officers traveled to the residence of Registrant on February 16, 2018, and “[a]fter displaying our credentials to Dr. Knight, I presented the original copy of the . . . [OSC] to Dr. Knight.” (Government Exhibit (hereinafter, GX) 8 at 2-3 (Declaration of DEA Diversion Investigator).
In its Request for Final Agency Action dated May 3, 2018, the Government represents that “[m]ore than 30-days have passed since Registrant received the . . . [OSC]; however, Registrant has not submitted to DEA a request for hearing.” Request for Final Agency Action, at 2. In its Request for Final Agency Action—Addendum dated September 26, 2018, the Government represents that Registrant has not “corresponded in writing or otherwise with regard to his position on a hearing before DEA.” Request for Final Agency Action—Addendum, at 2. The Government requests the issuance of a Final Order revoking Registrant's DEA registration.
Based on the DI's Declaration, the Government's written representations, and my review of the record, I find that the Government personally served the OSC on Registrant on February 16, 2018. I also find that more than 30 days have now passed since the date the Government served the OSC. Further, based on the Government's written representations, I find that neither Registrant, nor anyone purporting to represent him, requested a hearing, submitted a written statement while waiving Registrant's right to a hearing, or submitted a corrective action plan. Accordingly, I find that Registrant has waived his right to a hearing and his right to submit a written statement and corrective action plan. 21 CFR 1301.43(d) and 21 U.S.C. 824(c)(2)(C). I, therefore, issue this Decision and Order based on the record submitted by the Government, which constitutes the entire record before me. 21 CFR 1301.43(e).
Registrant is the holder of DEA Certificate of Registration No. BK7282940 at the registered address of 93
In this case, the Board issued an Order of Emergency License Suspension and Notice of Hearing on September 25, 2017. The Board's Order suspended Registrant's New Hampshire medical license until further order of the Board. GX 3 (Order of Emergency License Suspension and Notice of Hearing), at 13. On October 9, 2017, the Board accepted Registrant's agreement “not to practice medicine . . . [including the writing of] prescriptions . . . until further order of the Board.” GX 4 (Preliminary Agreement Not to Practice), at 1.
According to New Hampshire's online records, of which I take official notice, Registrant's license to practice medicine is still suspended.
Accordingly, I find that Registrant currently is not licensed to engage in the practice of medicine in New Hampshire, the State in which he is registered with the DEA.
Pursuant to 21 U.S.C. 824(a)(3), the Attorney General is authorized to suspend or revoke a registration issued under section 823 of the Controlled Substances Act (hereinafter, CSA), “upon a finding that the registrant . . . has had his State license or registration suspended . . . [or] revoked . . . by competent State authority and is no longer authorized by State law to engage in the . . . dispensing of controlled substances.” With respect to a practitioner, the DEA has also long held that the possession of authority to dispense controlled substances under the laws of the State in which a practitioner engages in professional practice is a fundamental condition for obtaining and maintaining a practitioner's registration.
This rule derives from the text of two provisions of the CSA. First, Congress defined the term “practitioner” to mean “a physician . . . or other person licensed, registered, or otherwise permitted, by . . . the jurisdiction in which he practices . . ., to distribute, dispense, . . . [or] administer . . . a controlled substance in the course of professional practice.” 21 U.S.C. 802(21). Second, in setting the requirements for obtaining a practitioner's registration, Congress directed that “[t]he Attorney General shall register practitioners . . . if the applicant is authorized to dispense . . . controlled substances under the laws of the State in which he practices.” 21 U.S.C. 823(f). Because Congress has clearly mandated that a practitioner possess State authority in order to be deemed a practitioner under the CSA, the DEA has held repeatedly that revocation of a practitioner's registration is the appropriate sanction whenever he is no longer authorized to dispense controlled substances under the laws of the State in which he practices.
In this case, according to the Board, the Registrant is alleged to have engaged in numerous acts of professional misconduct based upon,
Pursuant to 28 CFR 0.100(b) and the authority thus vested in me by 21 U.S.C. 824(a), I order that DEA Certificate of Registration No. BK7282940 issued to Eric Lee Knight, M.D., be, and it hereby is, revoked. Pursuant to 28 CFR 0.100(b) and the authority thus vested in me by 21 U.S.C. 823(f), I further order that any pending application of Eric Lee Knight, M.D., to renew or modify this registration, as well as any other pending application by him for registration in the State of New Hampshire, be, and it hereby is, denied. This Order is effective November 29, 2018.
Mine Safety and Health Administration (MSHA), Labor.
Notice.
The Federal Mine Safety and Health Act of 1977 and the Code of Federal Regulations govern the application, processing, and disposition of petitions for modification. This
Copies of the final decisions are posted on MSHA's website at
Barbara Barron at 202-693-9447 (voice),
Under section 101 of the Federal Mine Safety and Health Act of 1977, a mine operator may petition and the Secretary of Labor (Secretary) may modify the application of a mandatory safety standard to that mine if the Secretary determines that: (1) An alternative method exists that will guarantee no less protection for the miners affected than that provided by the standard; or (2) the application of the standard will result in a diminution of safety to the affected miners.
MSHA bases the final decision on the petitioner's statements, any comments and information submitted by interested persons, and a field investigation of the conditions at the mine. In some instances, MSHA may approve a
On the basis of the findings of MSHA's investigation, and as designee of the Secretary, MSHA has granted or partially granted the following petitions for modification:
•
•
•
•
•
•
•
Occupational Safety and Health Administration (OSHA), Department of Labor.
Notice of public meeting.
This notice is to advise interested persons that on Tuesday, November 13, 2018, OSHA will conduct a public meeting to discuss proposals in preparation for the 36th session of the United Nations Sub-Committee of Experts on the Globally Harmonized System of Classification and Labelling of Chemicals (UNSCEGHS) to be held December 5 through December 7, 2018, in Geneva, Switzerland. OSHA, along with the U.S. Interagency Globally Harmonized System of Classification and Labelling of Chemicals (GHS) Coordinating Group, plans to consider the comments and information gathered at this public meeting when developing the U.S. Government positions for the UNSCEGHS meeting. OSHA also will give an update on the Regulatory Cooperation Council (RCC).
Also on Tuesday, November 13, 2018, the Department of Transportation (DOT), Pipeline and Hazardous Materials Safety Administration (PHMSA) will conduct a public meeting (See Docket No. PHMSA-2018-0024 Notice No. 2018-11) to discuss proposals in preparation for the 54th session of the United Nations Sub-Committee of Experts on the Transport of Dangerous Goods (UNSCE TDG) to be held November 26 through December 4, 2018, in Geneva, Switzerland. During this meeting, PHMSA is also requesting comments relative to potential new work items that may be considered for inclusion in its international agenda. PHMSA will also provide an update on recent actions to enhance transparency and stakeholder interaction through improvements to the international standards portion of its website.
Tuesday, November 13, 2018.
Both meetings will be held at the DOT Headquarters Conference Center, West Building, Oklahoma City Conference Room, 1200 New Jersey Avenue SE, Washington, DC 20590.
Attendees may use the same form to pre-register for both meetings. Failure to pre-register may delay your access into the DOT Headquarters building. Additionally, if you are attending in person, arrive early to allow time for security checks necessary to access the building.
Conference call-in and “Skype meeting” capability will be provided for both meetings. Information on how to access the conference call and “Skype meeting” will be posted when available at:
At the Department of Transportation, please contact Mr. Steven Webb or Mr. Aaron Wiener, Office of Hazardous Materials Safety, Department of Transportation, Washington, DC 20590, telephone: (202) 366-8553.
At the Department of Labor, please contact Ms. Maureen Ruskin, OSHA Directorate of Standards and Guidance, Department of Labor, Washington DC 20210, telephone: (202) 693-1950, email:
General topics on the agenda include:
• Review of Working Papers.
• Correspondence Group updates.
• Regulatory Cooperation Council (RCC) update.
Information on the work of the UNSCEGHS including meeting agendas, reports, and documents from previous sessions can be found on the United Nations Economic Commission for Europe (UNECE) Transport Division website located at the following web address:
The UNSCEGHS bases its decisions on Working papers. The Working Papers for the 36th session of the UNSCEGHS are located at:
Informal Papers submitted to the UNSCEGHS provide information for the Sub-Committee and are used either as a mechanism to provide information to the Sub-Committee or as the basis for future Working Papers. Informal Papers for the 36th session of the UNSCEGHS are located at:
In addition to participating at the public meeting, interested parties may submit comments on the Working and Informal Papers for the 36th session of the UNSCEGHS to the docket established for International/Globally Harmonized System (GHS) efforts at
The primary purpose of PHMSA's meeting is to prepare for the 54th session of the UNSCE TDG. This session represents the third meeting scheduled for the 2017-2018 biennium. UNSCOE will consider proposals for the 21st Revised Edition of the
During this meeting, PHMSA is also soliciting input relative to preparing for the 54th session of the UNSCE TDG as well as potential new work items which may be considered for inclusion in its international agenda. Following the 54th session of the UNSCE TDG, a copy of the Sub-Committee's report will be available at the UN Transport Division's website at
Additional information regarding the UNSCE TDG and related matters can be found on PHMSA's website at
Notice.
The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the paperwork Reduction Act of 1995 (PRA95). This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. Currently, the Office of Workers' Compensation (OWCP) is soliciting comments concerning the proposed collection: Waiver of Service by Registered or Certified Mail for Employers and/or Insurance Carriers (LS-801) and Waiver of Service by Registered or Certified Mail for Claimants and Authorized Representatives (LS-802). A copy of the proposed information collection request can be obtained by contacting the office listed below in the address section of this Notice.
Written comments must be submitted to the office listed in the addresses section below on or before December 31, 2018.
You may submit comments by mail, delivery service, or by hand to Ms. Yoon Ferguson, U.S. Department of Labor, 200 Constitution Ave. NW, Room S-3323, Washington, DC 20210; by fax (202) 354-9647; or email to
The Office of Workers' Compensation Programs (OWCP) administers the Longshore and Harbor Workers' Compensation Act (LHWCA). The Act provides benefits to workers' injured in maritime employment on the navigable waters of the United States or in an adjoining area customarily used by an
The Longshore and Harbor Workers' Compensation Act (LHWCA), at 33 U.S.C. 919(e), requires that any order rejecting or making an LHWCA award (a compensation order) be filed in the appropriate district director's office of the Office of Workers' Compensation Programs (OWCP), and that copies be sent by registered or certified mail to the claimant and the employer. The implementing regulations at 20 CFR 702.349(b) allow parties and their representatives to waive certified mail service and consent to electronic service instead. The compensation order notifies Employers/Carriers that payment of LHWCA compensation is due within 10 days of filing. If compensation is not paid within that time frame, an additional 20% in compensation must be paid [see LHWCA § 914(f)].
The information collected will be used by OWCP to more efficiently serve compensation orders by email instead of by registered or certified mail. Form LS-801 will be completed by the employer/insurance carrier and/or an authorized representative and forwarded to the District Director indicating waiver of service by registered or certified mail and designation of receipt by email instead. The LS-802 will be completed by the claimants and/or an authorized representative and forwarded to the District Director indicating waiver of service by registered or certified mail and designation of receipt by email instead. This information collection is currently approved for use through February 28, 2019.
The Department of Labor is particularly interested in comments which:
* Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
* Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
* Enhance the quality, utility and clarity of the information to be collected; and
* Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
The Department of Labor seeks the extension of approval of this information collection in order to carry out its responsibility to meet the statutory requirements to provide compensation or death benefits under the Act to workers and survivors covered by the Act.
Comments submitted in response to this notice will be summarized and/or included in the request for Office of Management and Budget approval of the information collection request; they will also become a matter of public record.
National Endowment for the Arts.
Notice of meetings.
Pursuant to the Federal Advisory Committee Act, as amended, notice is hereby given that 28 meetings of the Arts Advisory Panel to the National Council on the Arts will be held by teleconference.
See the
National Endowment for the Arts, Constitution Center, 400 7th St. SW, Washington, DC 20506.
Further information with reference to these meetings can be obtained from Ms. Sherry Hale, Office of Guidelines & Panel Operations, National Endowment for the Arts, Washington, DC 20506;
The closed portions of meetings are for the purpose of Panel review, discussion, evaluation, and recommendations on financial assistance under the National Foundation on the Arts and the Humanities Act of 1965, as amended, including information given in confidence to the agency. In accordance with the determination of the Chairman of July 5, 2016, these sessions will be closed to the public pursuant to subsection (c)(6) of section 552b of title 5, United States Code.
The upcoming meetings are:
National Endowment for the Humanities.
Notice of meeting.
Pursuant to the Federal Advisory Committee Act, notice is hereby given that the National Council on the Humanities will meet to advise the Chairman of the National Endowment for the Humanities (NEH) with respect to policies, programs and procedures for carrying out his functions; to review applications for financial assistance under the National Foundation on the Arts and Humanities Act of 1965 and make recommendations thereon to the Chairman; and to consider gifts offered to NEH and make recommendations thereon to the Chairman.
The meeting will be held on Thursday, November 15, 2018, from 9:00 a.m. until 12:00 p.m., and Friday, November 16, 2018, from 9:00 a.m. until adjourned.
The meeting will be held at Constitution Center, 400 7th Street SW, Washington, DC 20506. See
Elizabeth Voyatzis, Committee Management Officer, 400 7th Street SW, 4th Floor, Washington, DC 20506; (202) 606-8322;
The National Council on the Humanities is meeting pursuant to the National Foundation on the Arts and Humanities Act of 1965 (20 U.S.C. 951-960, as amended). The Committee meetings of the National Council on the Humanities will be held on November 15, 2018, as follows: The policy discussion session (open to the public) will convene at 9:00 a.m. until approximately 10:30 a.m., followed by the discussion of specific grant applications and programs before the Council (closed to the public) from 10:30 a.m. until 12:00 p.m. The following Committees will meet in the NEH offices:
Digital Humanities: Room 4085.
Education Programs: Room 2002.
Federal/State Partnership: Room 4089.
Preservation and Access: Room 4002.
Public Programs: Room P002.
Research Programs: Room P003.
The plenary session of the National Council on the Humanities will convene on November 16, 2018, at 9:00 a.m. in the Conference Center at Constitution Center. The agenda for the morning session (open to the public) will be as follows:
The remainder of the plenary session will be for consideration of specific applications and therefore will be closed to the public.
As identified above, portions of the meeting of the National Council on the Humanities will be closed to the public pursuant to sections 552b(c)(4), 552b(c)(6), and 552b(c)(9)(B) of Title 5 U.S.C., as amended. The closed sessions will include review of personal and/or proprietary financial and commercial information given in confidence to the agency by grant applicants, and discussion of certain information, the premature disclosure of which could significantly frustrate implementation of proposed agency action. I have made this determination pursuant to the authority granted me by the Chairman's Delegation of Authority to Close Advisory Committee Meetings dated April 15, 2016.
Please note that individuals planning to attend the public sessions of the meeting are subject to security screening
Nuclear Regulatory Commission.
Draft NUREG; request for comment.
The U.S. Nuclear Regulatory Commission (NRC) is issuing for public comment a draft NUREG, NUREG/BR-0204, Rev. 3, “Instructions for Completing NRC's Uniform Low-Level Radioactive Waste Manifest.” This document provides instructions to prepare NRC Form 540 (Uniform Low-Level Radioactive Waste Manifest (Shipping Paper)), NRC Form 541 (Uniform Low-Level Radioactive Waste Manifest (Container and Waste Description)), and NRC Form 542 (Uniform Low-Level Radioactive Waste Manifest (Manifest Index and Regional Compact Tabulation)). NRC Forms 540 and 541 must be prepared for low-level radioactive waste intended for ultimate disposal at a licensed low-level radioactive waste land disposal facility. NRC Form 542 is required only if processors and collectors of low-level radioactive waste are shipping low-level radioactive waste attributed to others for disposal at a licensed low-level radioactive waste land disposal facility.
Submit comments by December 31, 2018. Comments received after this date will be considered if it is practical to do so, but the Commission is able to ensure consideration only for comments received before this date.
You may submit comments by any of the following methods:
• Federal Rulemaking Website: Go to
• Mail comments to: May Ma, Office of Administration, Mail Stop: TWFN-7-A60M, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.
For additional direction on obtaining information and submitting comments, see “Obtaining Information and Submitting Comments” in the
Lloyd Desotell, Office of Nuclear Material Safety and Safeguards, telephone: 301-415-5969, email:
Please refer to Docket ID NRC-2018-0155 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:
•
•
•
Please include Docket ID NRC-2018-0155 in your comment submission.
The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC will post all comment submissions at
If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment into ADAMS.
NUREG/BR-0204, Rev. 3, “Instructions for Completing the NRC's Uniform Low-Level Radioactive Waste Manifest,” provides guidance on completing NRC Forms 540, 541, and 542 (
In 2013, the NRC staff also identified additional changes that may be needed for the Uniform Low-Level Radioactive Waste Manifest forms and associated guidance in NUREG/BR-0204 as a part of the ongoing part 61 of title 10 of the Code of
Therefore, staff developed Regulatory Information Summary (RIS-15-002) to address stakeholder concerns regarding the reporting of hard-to-detect radionuclides on the Uniform Low-Level Radioactive Waste Manifest. This RIS, titled “Reporting of H-3, C-14, Tc-99, and I-129 on the Uniform Waste Manifest” (ADAMS Accession No. ML14272A217), informs addressees of the option to use indirect methods to determine the activity of H-3, C-14, Tc-99, and I-129 reported on the Uniform Low-Level Radioactive Waste Manifest when the radionuclide is present at a concentration less than the lower limit of detection (LLD). The request for comments on draft RIS was published on in the
In September of 2017, the NRC received direction from the Commission on the part 61 rulemaking in SRM-SECY-16-0106 (ADAMS Accession No. ML17251B147), and the NRC staff determined that there was enough certainty in the portions of the part 61 rulemaking that affected the Uniform Low-Level Radioactive Waste Manifest to issue a draft of the manifest forms and the instructions in NUREG/BR-0204 for comment. The NRC staff considered the comments received in 2013 when revising these documents. Major areas of revision include: Updated references to Department of Transportation (DOT) regulations to reflect the current DOT regulations, additional discussion on the reporting of inventories based on LLD values, the potential use of indirect methods to determine these inventories, including the use of indirect methods in waste classification, clarification of the certification statement on Form 540, and overall improvements to the clarity of NUREG/BR-0204.
The NRC is requesting public comments on the draft revised Uniform Low-Level Radioactive Waste Manifest (NRC Forms 540, 541, and 542) and on the draft Rev. 3 to NUREG/BR-0204, and on the draft regulatory analysis. The NRC staff will consider any comments received in preparing the final version of Rev. 3 and the revised NRC Forms 540, 541, and 542. In responding, commenters are encouraged to provide specific suggestions and the basis for suggestions offered. Specifically, the NRC staff requests comment on the following questions:
1. Do the proposed revised Uniform Low-Level Radioactive Waste Manifest Forms 540, 541, and 542 request all of the information that is needed for the transport and disposal of low-level radioactive waste to be safely managed? Is there any additional information that should be collected?
2. Is any additional guidance or clarification needed in the instructions for filling out the Uniform Low-Level Radioactive Waste Manifest Forms in NUREG/BR-0204?
3. NRC Form 541 has lists of container description codes (note 1), waste descriptor codes (note 2), and sorption and solidification media (note 3) that have not been updated recently. Are there any items that should be added to these lists based on new technology or changes to industry practices? Are there any items on these lists that should be deleted because they are no longer in use or for any other reason? Should the items in the lists be combined in any way?
For the Nuclear Regulatory Commission.
Weeks of October 29, November 5, 12, 19, 26, December 3, 2018.
Commissioners' Conference Room, 11555 Rockville Pike, Rockville, Maryland.
Public and Closed.
This meeting will be webcast live at the web address—
There are no meetings scheduled for the week of November 5, 2018.
There are no meetings scheduled for the week of November 12, 2018.
There are no meetings scheduled for the week of November 19, 2018.
This meeting will be webcast live at the web address—
This meeting will be webcast live at the Web address—
For more information or to verify the status of meetings, contact Denise McGovern at 301-415-0681 or via email at
The NRC Commission Meeting Schedule can be found on the internet at:
The NRC provides reasonable accommodation to individuals with disabilities where appropriate. If you need a reasonable accommodation to participate in these public meetings, or need this meeting notice or the transcript or other information from the public meetings in another format (
Members of the public may request to receive this information electronically. If you would like to be added to the distribution, please contact the Nuclear Regulatory Commission, Office of the Secretary, Washington, DC 20555 (301-415-1969), or you may email
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Exemption and combined license amendment; issuance.
The U.S. Nuclear Regulatory Commission (NRC) is granting an exemption for prior NRC approval of any departure from Tier 2* information or any departure from Tier 2 information that involves a change to or departure from Tier 2* information, provided that specified criteria are not met, and is issuing License Amendment Nos. 142 and 141 to Combined Licenses (COLs) NPF-91 and NPF-92, respectively. The COLs were issued to Southern Nuclear Operating Company, Inc., and Georgia Power Company, Oglethorpe Power Corporation, MEAG Power SPVM, LLC, MEAG Power SPVJ, LLC, MEAG Power SPVP, LLC, and the City of Dalton, Georgia (collectively SNC); for construction and operation of the Vogtle Electric Generating Plant (VEGP) Units 3 and 4, located in Burke County, Georgia.
The granting of the exemption allows the imposition of License Condition 2.D.13 asked for in the amendment request. Because the acceptability of the exemption was determined in part by the acceptability of the amendment, the exemption and amendment are being issued concurrently.
The exemption and amendment were issued on September 20, 2018.
Please refer to Docket ID NRC-2008-0252 when contacting the NRC about the availability of information regarding this document. You may obtain publicly-available information related to this document using any of the following methods:
•
•
•
Chandu Patel, Office of New Reactors, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-3025; email:
The NRC is granting an exemption from paragraphs B.5.a, B.6.b, and B.6.c of section VIII, “Processes for Changes and Departures,” of Appendix D, of Part 52 of Title 10 of the
Part of the justification for granting the exemption was provided by the review of the amendment. Because the exemption is necessary in order to issue the requested license amendment, the NRC granted the exemption and issued the amendment concurrently, rather than in sequence. This included issuing a combined safety evaluation containing the NRC staff's review of both the exemption request and the license amendment. The exemption met all applicable regulatory criteria set forth in Sections 50.12 and 52.7 of 10 CFR part 52. The license amendment was found to be acceptable as well. The combined safety evaluation is available in ADAMS under Accession No. ML18207A262.
Identical exemption documents (except for referenced unit numbers and license numbers) were issued to SNC for VEGP Units 3 and 4 (COLs NPF-91 and NPF-92). The exemption documents for VEGP Units 3 and 4 can be found in ADAMS under Accession Nos. ML18235A031 and ML18235032, respectively. The exemption is reproduced (with the exception of abbreviated titles and additional citations) in Section II of this document. The amendment documents for COLs NPF-91 and NPF-92 are available in ADAMS under Accession Nos. ML18235A033 and ML18235A035, respectively. A summary of the amendment documents is provided in Section III of this document.
Reproduced below is the exemption document issued to VEGP Units 3 and 4. It makes reference to the combined safety evaluation that provides the reasoning for the findings made by the NRC (and listed under Item 1) in order to grant the exemption:
1. In a letter dated December 21, 2017, as supplemented by letters dated April 6, May 11, June 18, August 3, August 10, and September 13, 2018, SNC requested from the Commission an exemption from the requirements of 10 CFR part 52, Appendix D, “Design Certification Rule for the AP1000 Design,” Section VIII, “Processes for Changes and Departures,” paragraphs VIII.B.5.a, VIII.B.6.b, and VIII.B.6.c, for prior NRC approval of any departure from Tier 2* information or any departure from Tier 2 information that involves a change to or departure from Tier 2* information, provided that specified criteria are not met. SNC specified the criteria in a new license condition in license amendment request (LAR) 17-037, “Changes to the Tier 2* Departure Evaluation Process,” which SNC submitted together with the exemption request. The proposed license condition would allow SNC to apply the change process for Tier 2 information in 10 CFR part 52, Appendix D, Section VIII.B.5, to a
A. the exemption is authorized by law;
B. the exemption presents no undue risk to public health and safety;
C. the exemption is consistent with the common defense and security;
D. special circumstances are present in that the application of the rule in this circumstance is not necessary to serve the underlying purpose of the rule;
2. Accordingly, SNC is granted an exemption from the requirements to obtain prior NRC approval for any departure from Tier 2* information and an exemption from the requirement to obtain prior NRC approval for any departure from Tier 2 information that involves a change to or departure from Tier 2* information, as described in the licensee's request dated December 21, 2017, as supplemented by letters dated April 6, May 11, June 18, August 3, August 10, and September 13, 2018, provided that each of the criteria in License Condition 2.D.(13)(a) is not met for each such departure. These exemptions are related to, and necessary for the granting of License Amendment No. 142, which is being issued concurrently with this exemption.
3. As explained in Section 6.0 of the NRC staff's Safety Evaluation (ADAMS Accession No. ML18207A262), this exemption meets the eligibility criteria for categorical exclusion set forth in 10 CFR 51.22(c)(9). Therefore, pursuant to 10 CFR 51.22(b), no environmental impact statement or environmental assessment needs to be prepared in connection with the issuance of the exemption.
4. This exemption is effective as of the date of its issuance.
By letter dated December 21, 2017 (ADAMS Accession No. ML17355A416), SNC requested that the NRC amend the COLs for VEGP, Units 3 and 4, COLs NPF-91 and NPF-92. The proposed amendment is described in Section I of this
The Comission has determined for these amendments that the application complies with the standards and requirements of the Atomic Energy Act of 1954, as amended (the Act), and the Commission's rules and regulations. The Commission has made appropriate findings as required by the Act and the Commission's rules and regulations in 10 CFR Chapter I, which are set forth in the license amendment.
A notice of consideration of issuance of amendment to facility operating license or COL, as applicable, proposed no significant hazards consideration determination, and opportunity for a hearing in connection with these actions, was published in the
The Commission has determined that these amendments satisfy the criteria for categorical exclusion in accordance with 10 CFR 51.22. Therefore, pursuant to 10 CFR 51.22(b), no environmental impact statement or environmental assessment need be prepared for these amendments.
Using the reasons set forth in the combined safety evaluation, the staff granted the exemption and issued the amendment that SNC requested on September 20, 2018. The exemption and amendment were issued on September 20, 2018, as part of a combined package to the licensee (ADAMS Accession No. ML18235A029).
For the Nuclear Regulatory Commission.
In accordance with the purposes of Sections 29 and 182b of the Atomic Energy Act (42 U.S.C. 2039, 2232b), the Advisory Committee on Reactor Safeguards (ACRS) will hold meetings on November 1-3, 2018, Three White Flint North, 11601 Landsdown Street, North Bethesda, MD 20852.
Procedures for the conduct of and participation in ACRS meetings were published in the
Thirty-five hard copies of each presentation or handout should be provided 30 minutes before the meeting. In addition, one electronic copy of each presentation should be emailed to the Cognizant ACRS Staff one day before meeting. If an electronic copy cannot be provided within this timeframe, presenters should provide the Cognizant ACRS Staff with a CD containing each presentation at least 30 minutes before the meeting.
In accordance with Subsection 10(d) of Public Law 92-463 and 5 U.S.C. 552b(c), certain portions of this meeting may be closed, as specifically noted above. Use of still, motion picture, and television cameras during the meeting may be limited to selected portions of the meeting as determined by the Chairman. Electronic recordings will be permitted only during the open portions of the meeting.
ACRS meeting agendas, meeting transcripts, and letter reports are available through the NRC Public Document Room at
Video teleconferencing service is available for observing open sessions of ACRS meetings. Those wishing to use this service should contact Mr. Theron Brown, ACRS Audio Visual Technician (301-415-6702), between 7:30 a.m. and 3:45 p.m. (ET), at least 10 days before the meeting to ensure the availability of this service. Individuals or organizations requesting this service will be responsible for telephone line charges and for providing the equipment and facilities that they use to establish the video teleconferencing link. The availability of video teleconferencing services is not guaranteed.
The “Waterford Steam Electric Station, Unit 3 License Renewal Application” meeting was listed on the previous notice as ending at 10 a.m. but is currently scheduled to end at 10:30 a.m.
Office of Personnel Management.
Notice of meeting.
The Federal Salary Council will meet on Tuesday, November 13, 2018, at the time and location shown below. The Council is an advisory body composed of representatives of Federal employee organizations and experts in the fields of labor relations and pay policy. The Council makes recommendations to the President's Pay Agent (the Secretary of Labor and the Directors of the Office of Management and Budget and the Office of Personnel Management) about the locality pay program for General Schedule employees. The Council's recommendations cover the establishment or modification of locality pay areas, the coverage of salary surveys, the process of comparing Federal and non-Federal rates of pay, and the level of comparability payments that should be paid.
The Council will hear public testimony about the locality pay program, review the results of pay comparisons, and formulate its recommendations to the President's Pay Agent on pay comparison methods, locality pay rates, and locality pay areas and boundaries for 2020.
The meeting is open to the public. Individuals who wish to provide testimony or present material at the meeting should contact the Office of Personnel Management using the telephone number or email address provided below. In addition, please be aware that the Council asks that oral testimony at the meeting be limited to 5 minutes per speaker.
Tuesday, November 13, 2018, at 1:00 p.m.
Office of Personnel Management, 1900 E Street NW, Room 1350, Washington, DC 20415.
Brenda L. Roberts, Deputy Associate Director, Pay and Leave, Office of Personnel Management, 1900 E Street NW, Room 7H31, Washington, DC 20415-8200. Phone (202) 606-2838; FAX (202) 606-0824; or email at
For The President's Pay Agent.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
Cboe EDGX Exchange, Inc. (the “Exchange” or “EDGX Options”) proposes to permit the listing and trading of P.M.-settled series on certain broad-based index options on a pilot basis. [The text of the proposed rule change is provided below.] [sic]
The text of the proposed rule change is also available on the Exchange's
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The proposed rule change permits the listing and trading of P.M.-settled series on certain broad-based index options on a pilot basis.
Proposed Rule 29.11(a)(6) permits the listing and trading, in addition to A.M.-settled XSP options, of P.M.-settled XSP options with third-Friday-of-the-month expiration dates on a pilot basis for an initial period of 12 months from the date of approval of this proposed rule change. XSP options are A.M.-settled pursuant to the generic listing criteria in Rule 29.11(a)(5). The Exchange believes permitting the trading of XSP options on a P.M.-settled basis will encourage greater trading in XSP options.
Other than settlement and closing time on the last trading day (as discussed below), contract terms for P.M.-settled XSP options will be the same as the A.M.-settled XSP options. The proposed contract would use a $100 multiplier. The minimum trading increments, strike price intervals, and expirations would be the same as the A.M.-settled XSP option series. P.M.-settled XSP options would have European-style exercise. The Exchange will also have flexibility to open for trading additional series in response to customer demand.
The proposed rule change amends Rule 29.10(a) to state that, on their last trading day, transactions in P.M.-settled XSP options may be effected on the Exchange between the hours of 9:30 a.m. and 4:00 p.m. Eastern time (as opposed to the normal trading hours for non-expiring P.M.-settled XSP options, which are from 9:30 a.m. to 4:15 p.m. Eastern time). XSP options are typically priced in the market based on corresponding futures values. The primary listing markets for the component securities that comprise the S&P 500 Index close trading in those securities at 4:00 p.m. The primary listing exchanges for the component securities disseminate closing prices of the component securities, which are used to calculate the exercise settlement value of the S&P 500 Index. The Exchange believes that, under normal trading circumstances, the primary listing markets have sufficient bandwidth to prevent any data queuing that would cause any trades that are executed prior to the closing time from being reported after 4:00 p.m. Despite the fact that the exercise settlement value will be fixed at or soon after 4:00 p.m., if the Exchange did not close trading in expiring P.M.-settled XSP options at 4:00 p.m. on their last trading day, trading in expiring P.M.-settled XSP options would continue for an additional fifteen minutes until 4:15 p.m. and would not be able to be priced on corresponding futures values, but rather the known cash value. At the same time, the prices of non-expiring P.M.-settled XSP option series would continue to move and be priced in response to changes in corresponding futures prices.
A potential pricing divergence could occur between 4:00 p.m. and 4:15 p.m. on the final trading day in expiring P.M.-settled XSP options (
If the Exchange were to propose an extension of the XSPPM Pilot Program or should the Exchange propose to make the XSPPM Pilot Program permanent, the Exchange would submit a filing proposing such amendments to the XSPPM Pilot Program. Further, any positions established under the XSPPM Pilot Program would not be impacted by the expiration of the XSPPM Pilot Program. For example, if the Exchange lists a P.M.-settled XSP option that expires after the XSPPM Pilot Program expires (and is not extended), then those positions would continue to exist. If the pilot were not extended, then the positions could continue to exist. However, any further trading in those series would be restricted to transactions where at least one side of the trade is a closing transaction.
As part of the XSPPM Pilot Program, the Exchange will submit a pilot report to the Commission at least two months prior to the expiration date of the pilot. This annual report will contain an analysis of volume, open interest, and trading patterns. The analysis would examine trading in the proposed option product as well as trading in the securities that comprise the S&P 500 Index. In addition, for series that exceed certain minimum open interest parameters, the annual report will provide analysis of index price volatility and, if needed, share trading activity.
The annual report will contain the following volume and open interest data:
(1) Monthly volume aggregated for all trades;
(2) monthly volume aggregated by expiration date;
(3) monthly volume for each individual series;
(4) month-end open interest aggregated for all series;
(5) month-end open interest aggregated by expiration date; and
(6) month-end open interest for each individual series.
The annual report will also contain the information noted above for expiration Friday A.M.-settled XSP option series, if applicable, for the period covered in the annual report. In addition to the annual report, the Exchange will provide the Commission with interim reports of the information listed in (1) through (6) above.
In the annual report, the annual report would contain the following analysis of trading patterns in expiration Friday, P.M.-settled XSP option series in the XSPPM Pilot Program:
(1) A time series analysis of open interest; and
(2) an analysis of the distribution of trade sizes.
Also, for series that exceed certain minimum parameters, the annual report will also contain the following analysis related to index price changes and, if needed, underlying share trading volume at the close on expiration Fridays:
(1) A comparison of index price changes at the close of trading on a given expiration Friday with comparable price changes from a control sample. The data will include a calculation of percentage price changes for various time intervals and compare that information to the respective control sample. Raw percentage price change data as well as percentage price change data normalized for prevailing market volatility, as measured by an appropriate index as agreed by the Commission and the Exchange, would be provided; and
(2) a calculation of share volume for a sample set of the component securities representing an upper limit on share trading that could be attributable to expiring in-the-money series. The data, if needed, will include a comparison of the calculated share volume for securities in the sample set to the average daily trading volumes of those securities over a sample period.
The minimum open interest parameters, control sample, time intervals, method for randomly selecting the component securities, and sample periods would be determined by the Exchange and the Commission.
Additionally, the Exchange will provide the Commission with any additional data or analyses the Commission requests because it deems such data or analyses necessary to determine whether the XSPPM Pilot Program is consistent with the Exchange Act. The Exchange will make public all data and analyses it submits to the Commission under the XSPPM Pilot Program.
Other exchanges currently have pilots that permit P.M.-settled index options.
The proposed rule change permits the listing and trading, on a pilot basis, of P.M.-settled options on broad-based indexes with nonstandard expiration dates for an initial period of 12 months from the date of approval of this proposed rule change. The Nonstandard Expirations Pilot Program will permit both Weeklys and EOMs as discussed below. Contract terms for the Weekly and EOM expirations will be similar to those of the A.M.-settled broad-based index options, except that the Weekly and EOM expirations will be P.M.-settled.
Proposed Rule 29.11(j)(1) permits the Exchange to open for trading Weeklys on any broad-based index eligible for standard options trading to expire on any Monday, Wednesday, or Friday (other than the third Friday-of-the-month or days that coincide with an EOM). Weeklys will be subject to all provisions of Rule 29.11 and will be treated the same as options on the same underlying index that expire on the third Friday of the expiration month. However, Weeklys will be P.M.-settled, and new Weekly series may be added up to and including on the expiration date for an expiring Weekly.
The maximum number of expirations that may be listed for each Weekly (
Proposed Rule 29.11(a)(2) [sic] permits the Exchange to open for trading EOMs on any broad-based index eligible for standard options trading to expire on the last trading day of the month. EOMs will be subject to all provisions of Rule 29.11 and treated the same as options on the same underlying index that expire on the third Friday of the expiration month. However, EOMs will be P.M.-settled, and new series of EOMs may be added up to and including on the expiration date for an expiring EOM.
The maximum number of expirations that may be listed for EOMs in a given class is the same as the maximum number of expirations permitted in Rule 29.11(a)(3) for standard options on the same broad-based index.
The proposed rule change amends Rule 29.11(c)(5)(C) to provide that the lowest strike interval for series of XSP options listed under the Nonstandard Expirations Pilot Program will be $0.50. With respect to XSP, this is consistent with the minimum strike interval for XSP options listed under the Short Term Series Program.
Weeklys and EOMs will be subject to the same rules that currently govern the trading of standard monthly broad-based index options, including sales practice rules, margin requirements, and floor trading procedures. Contract terms for Weeklys and EOMs will be the same as those for standard monthly broad-based index options. Since Weeklys and EOMs will be new types of series, and not a new class, the Exchange proposes that Weeklys and EOMs will be aggregated for any applicable reporting and other requirements.
As stated above, this proposed rule change establishes a Nonstandard Expirations Pilot Program for broad-based index options on a pilot basis, for an initial period of 12 months from the date of approval of this proposed rule change. If the Exchange were to propose an extension of the Nonstandard Expirations Pilot Program or should the Exchange propose to make it permanent, the Exchange would submit a filing proposing such amendments. Further, any positions established under the Nonstandard Expirations Pilot Program would not be impacted by the expiration of the pilot. For example, if the Exchange lists a Weekly or EOM that expires after the Nonstandard Expirations Pilot Program expires (and is not extended), then those positions would continue to exist. However, any further trading in those series would be restricted to transactions where at least one side of the trade is a closing transaction.
As part of the Nonstandard Expirations Pilot Program, the Exchange will submit a pilot report to the Commission at least two months prior to the expiration date of the pilot (the “annual report”). The annual report will contain an analysis of volume, open interest, and trading patterns. In addition, for series that exceed certain minimum open interest parameters, the annual report will provide analysis of the index price volatility, and, if needed, share trading activity.
For all Weekly and EOM series, the annual report will contain the following volume and open interest data for each broad-based index overlying Weekly and EOM options:
(1) Monthly volume aggregated for all Weekly and EOM series;
(2) Volume in Weekly and EOM series aggregated by expiration date;
(3) Month-end open interest aggregated for all Weekly and EOM series;
(4) Month-end open interest for EOM series aggregated by expiration date and open interest for Weekly series aggregated by expiration date;
(5) Ratio of monthly aggregate volume in Weekly and EOM series to total monthly class volume; and
(6) Ratio of month-end open interest in EOM series to total month-end class open interest and ratio of open interest in each Weekly series to total class open interest.
In addition, the annual report will contain the information noted above for standard expiration Friday, A.M.-settled series, if applicable, for the period covered in the annual report as well as for the six-month period prior to the initiation of the pilot.
Upon request by the SEC, the Exchange will provide a data file containing: (1) Weekly and EOM option volume data aggregated by series, and
(2) Weekly open interest for each expiring series and EOM month-end open interest for expiring series.
In the annual report, the Exchange also proposes to identify Weekly and EOM trading patterns by undertaking a time series analysis of open interest in Weekly and EOM series aggregated by expiration date compared to open interest in near-term standard expiration Friday A.M.-settled series in order to determine whether users are shifting positions from standard series to Weekly and EOM series. In addition, to the extent that data on other weekly or monthly P.M.-settled products from other exchanges is publicly available, the report will also compare open interest with these options in order to determine whether users are shifting positions from other weekly or monthly P.M.-settled products to the Weekly and EOM series. Declining open interest in standard series or the weekly or monthly P.M.-settled products of other exchanges accompanied by rising open interest in Weekly and EOM series would suggest that users are shifting positions.
For each Weekly and EOM expiration that has open interest that exceeds certain minimum thresholds, the annual report will contain the following analysis related to index price changes and, if needed, underlying share trading volume at the close on expiration dates:
(1) A comparison of index price changes at the close of trading on a given expiration date with comparable price changes from a control sample. The data will include a calculation of percentage price changes for various time intervals and compare that information to the respective control sample. Raw percentage price change data as well as percentage price change data normalized for prevailing market volatility, as measured by an appropriate index agreed to by the Commission and the Exchange, will be provided; and
(2) If needed, a calculation of share volume for a sample set of the component securities representing an upper limit on share trading that could be attributable to expiring in-the-money Weekly and EOM series. The data, if needed, will include a comparison of the calculated share volume for securities in the sample set to the average daily trading volumes of those securities over a sample period.
The minimum open interest parameters, control sample, time intervals, method for selecting the component securities, and sample periods will be determined by the Exchange and the Commission.
Additionally, the Exchange will provide the Commission with any additional data or analyses the Commission requests because it deems such data or analyses necessary to determine whether the Nonstandard Expirations Pilot Program is consistent with the Exchange Act. The Exchange will make public all data and analyses it submits to the Commission under the Nonstandard Expirations Pilot Program. Other exchanges currently have pilots that have weekly and end-of-month expirations.
Precedent exists for P.M.-settled broad-based index options, as other options exchanges list P.M.-settled broad-based index options.
The Exchange notes that P.M.-settled options predominate in the over-the-counter (“OTC”) market, and the Exchange is not aware of any adverse effects in the stock market attributable to the P.M.-settlement feature. The Exchange is merely proposing to offer a P.M.-settled product in an exchange environment that offers the benefit of added transparency, price discovery, and stability. In response to any potential concerns that disruptive trading conduct could occur as a result of the concurrent listing and trading of two index option products based on the same index but for which different settlement methodologies exist (
The adoption of P.M.-settled options on an exchange that lists A.M.-settled options in the same class would provide greater spread opportunities. This manner of trading in different products allows a market participant to take advantage of the different expiration times, providing expanded trading opportunities. In the options market currently, market participants regularly trade similar or related products in conjunction with each other, which contributes to overall market liquidity.
The Exchange represents it has an adequate surveillance program in place for index options. The Exchange is a member of the Intermarket Surveillance Group (“ISG”), which is comprised of an international group of exchanges, market centers, and market regulators. The purpose of ISG is to provide a framework for the sharing of information and the coordination of regulatory efforts among exchanges trading securities and related products to address potential intermarket manipulations and trading abuses. ISG plays a crucial role in information sharing among markets that trade securities, options on securities, security futures products, and futures and options on broad-based security indexes. A list of identifying current ISG members is available at
The Exchange has analyzed its capacity and represents that it believes the Exchange and OPRA have the necessary systems capacity to handle the additional traffic associated with the listing of P.M.-settled XSP and Weekly/EOM option series up to the proposed number of possible expirations and strike prices. The Exchange believes any additional traffic that would be generated from the introduction of P.M.-settled XSP and Weekly/EOM options series will be manageable. The Exchange believes its Members will not have a capacity issue as a result of this proposed rule change. The Exchange also represents that it does not believe this expansion will cause fragmentation of liquidity. The Exchange will monitor the trading volume associated with the additional options series listed as a result of this proposed rule change and the effect (if any) of these additional series on market fragmentation and on the capacity of the Exchange's automated systems.
P.M.-settled options would be subject to all provisions of Rule 29.11. P.M.-settled options would be subject to the same rules that govern the trading of A.M.-settled options overlying the same indexes, including sales practice rules, margin requirements, and floor trading procedures. P.M.-settled options will be subject to the margin requirements set forth in Chapter 28 and the position limits set forth in Rule 29.5. Chapter 28 imposes the margin requirements of either Cboe Options or the New York Stock Exchange on Exchange Options Members. Similarly, Rule 29.5 imposes position (and exercise) limits for broad-based index options of Cboe Options on Exchange Options Members. Since P.M.-settled options will be a new type of series, and not a new class, the Exchange proposes that the P.M.-settled options will be aggregated for any applicable reporting and other requirements.
The Exchange believes the proposed rule change is consistent with the Securities Exchange Act of 1934 (the “Act”) and the rules and regulations thereunder applicable to the Exchange and, in particular, the requirements of Section 6(b) of the Act.
The Exchange believes the proposed rule change will attract order flow to the Exchange, increase the variety of listed options to investors, and provide a valuable hedge tool to investors. The Exchange believes the proposed rule change will also remove impediments to and perfect the mechanism of a free and open market, and in general protect investors by expanding the ability of investors to hedge risks against market movements stemming from economic releases or market events that occur during the month and at the end of the month. Accordingly, the Exchange believes that P.M.-settled options will create greater trading and hedging opportunities and flexibility, and
The Commission has previously stated that when cash-settled index options were first introduced in the 1980s, they generally utilized closing-price settlement procedures (
However, the Exchange believes that the above concerns that have led to the transition to A.M. settlement for index derivatives have been largely mitigated. It believes that expiration pressure in the underlying cash markets at the close has been greatly reduced with the advent of multiple primary listing and unlisted trading privilege markets, and that trading is now widely dispersed among many market centers. Additionally, the Exchange notes that opening procedures in the 1990s were deemed acceptable to mitigate one-sided order flow driven by index option expiration and that the New York Stock Exchange and Nasdaq Stock Market, LLC each use an automated closing cross procedures and has a closing order type that facilitates orderly closings. These closing procedures on the exchanges on which the components of the S&P 500 Index trade are well-equipped to mitigate imbalance pressure at the close. In addition, after-hours trading now provides market participants with an alternative to help offset market-on-close imbalances.
Other exchanges currently have pilots that permit P.M.-settled index options
The proposed rule change to permit transactions on the Exchange in P.M.-settled XSP and Weekly/EOM options on their last trading day between the hours of 9:30 a.m. and 4:00 p.m. Eastern time (as opposed to the normal trading hours for non-expiring P.M.-settled XSP and Weekly/EOM options, which are from 9:30 a.m. to 4:15 p.m. Eastern time) will prevent potential pricing divergence that could occur between 4:00 p.m. and 4:15 p.m. on the final trading day in expiring P.M.-settled XSP options. Without closing expiring contracts at 4:00 p.m., it is foreseeable that Market-Makers would react by widening spreads in order to compensate for the additional risk. Therefore, the Exchange believes that, in order to mitigate potential investor confusion and the potential for increased costs to investors, it is appropriate to cease trading in the expiring P.M.-settled XSP and Weekly/EOM contracts at 4:00 p.m. The Exchange does not believe the proposed change will impact volatility on the underlying cash market at the close on third Fridays. Further, the other options exchanges close trading in certain options on the last trading day for certain classes.
The Exchange has analyzed its capacity and represents that it believes the Exchange and OPRA have the necessary systems capacity to handle the additional traffic associated with the listing of P.M.-settled options. The Exchange believes any additional traffic that may be generated from the introduction of P.M.-settled options will be manageable. The Exchange represents that it has in place adequate surveillance procedures to monitor trading in these options thereby helping to ensure the maintenance of a fair and orderly market.
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. P.M.-settled options would be available for trading on the Exchange to all market participants. The Exchange believes the proposed rule change will increase the variety of listed options to investors, and provide valuable hedge tools to investors. The listing of P.M.-settled options will enhance competition by providing investors with an additional investment vehicle, through which investors can gain and hedge exposure to the stocks that compose the applicable broad-based indexes. Additionally, markets participants are welcome to become Members and trade at the Exchange if they determine this proposed rule change has made the Exchange more attractive or favorable. Further, this product could offer a competitive alternative to other existing investment products that seek to allow Members to gain broad market exposure. Finally, all options exchanges are free to compete by listing and trading index options that are P.M.-settled. Other exchanges currently have pilots that permit P.M.-settled index options
The proposed rule change to permit transactions on the Exchange in P.M.-settled XSP and Weekly/EOM options on their last trading day between the hours of 9:30 a.m. and 4:00 p.m. Eastern time (as opposed to the normal trading hours for non-expiring P.M.-settled XSP and Weekly/EOM options, which are from 9:30 a.m. to 4:15 p.m. Eastern time) will prevent potential pricing divergence that could occur between 4:00 p.m. and 4:15 p.m. on the final trading day in expiring P.M.-settled XSP and Weekly/EOM options. Without closing expiring contracts at 4:00 p.m., it is foreseeable that Market-Makers would react by widening spreads in order to compensate for the additional risk. Therefore, the Exchange believes that, in order to mitigate potential investor confusion and the potential for increased costs to investors, it is appropriate to cease trading in the expiring P.M.-settled XSP and Weekly/EOM contracts at 4:00 p.m. The Exchange does not believe the proposed change will impact volatility on the underlying cash market at the close on third Fridays. Further, the other options exchanges close trading in certain options on the last trading day for certain classes.
The Exchange believes that the proposed rule change will relieve any burden on, or otherwise promote, competition, as the rules are substantially the same as those of other options exchanges, as noted above.
The Exchange neither solicited nor received comments on the proposed rule change.
Within 45 days of the date of publication of this notice in the
A. by order approve or disapprove such proposed rule change, or
B. institute proceedings to determine whether the proposed rule change should be disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
2:00 p.m. on Thursday, November 1, 2018.
The meeting will be held at the Commission's headquarters, 100 F Street NE, Washington, DC 20549.
This meeting will be closed to the public.
Commissioners, Counsel to the Commissioners, the Secretary to the Commission, and recording secretaries will attend the closed meeting. Certain staff members who have an interest in the matters also may be present.
The General Counsel of the Commission, or his designee, has certified that, in his opinion, one or more of the exemptions set forth in 5 U.S.C. 552b(c)(3), (5), (6), (7), (8), 9(B) and (10) and 17 CFR 200.402(a)(3), (a)(5), (a)(6), (a)(7), (a)(8), (a)(9)(ii) and (a)(10), permit consideration of the scheduled matters at the closed meeting.
Commissioner Peirce, as duty officer, voted to consider the items listed for the closed meeting in closed session.
The subject matters of the closed meeting will be:
Institution and settlement of injunctive actions;
Institution and settlement of administrative proceedings; and
Other matters relating to enforcement proceedings.
At times, changes in Commission priorities require alterations in the scheduling of meeting items.
For further information and to ascertain what, if any, matters have been added, deleted or postponed; please contact Brent J. Fields from the Office of the Secretary at (202) 551-5400.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to delete the current rules on arbitration (“Current Arbitration Rules”), under the 10000 Series (Rules 10001 through 10102), and incorporate by reference The Nasdaq
The text of the proposed rule change is available on the Exchange's website at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Exchange proposes to delete the rules on arbitration, currently under the 10000 Series (Rules 10001 through 10102), and incorporate by reference the Nasdaq rules on arbitration at General 6 of Nasdaq's rulebook into General 6 of the Exchange's Rulebook.
The Exchange adopted the Current Arbitration Rules to ensure a fair and efficient manner in which to handle any dispute, claim or controversy arising out of, or in connection with, the business of any Member of the Exchange. To help administer the process of dispute resolution, the Exchange and FINRA are parties to a Regulatory Contract, pursuant to which FINRA has agreed to perform certain functions and provide access to certain services, including: Member regulation and registration; non-real time market surveillance; examinations and investigations; and dispute resolution. FINRA currently operates the largest securities dispute resolution forum in the United States,
Because the Affiliated Exchanges are also parties to similar Regulatory Contracts with FINRA that make their members and associated persons of such members subject to the FINRA Code of Arbitration Procedure, the Exchange believes it is pertinent that a common set of rules on arbitration be included in the General section of the Rulebook's shell. Nasdaq completed this process recently
Therefore, the Exchange will incorporate by reference the Proposed Arbitration Rules in “General 6 Arbitration” of the shell's “General Equity and Options Rules” section.
The relocation and harmonization of the arbitration rules is part of the Exchange's continued effort to promote efficiency and conformity of its processes with those of its Affiliated Exchanges.
BX will continue to file proposed rule changes to amend its General 6 Rules until such time as it receives an exemption from the Securities and Exchange Commission, pursuant to its authority under Section 36 of the Exchange Act of 1934 (“Act”) and Rule 0-12
The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act. The proposed changes do not impose a burden on competition because, as previously stated, they are (i) of a non-substantive nature, (ii) intended to harmonize the structure of the Exchange's rules with those of its Affiliated Exchanges, and (iii) intended to organize the Rulebook in a way that it will ease the Members' navigation and reading of the rules across the Affiliated Exchanges.
No written comments were either solicited or received.
Because the foregoing proposed rule change does not: (i) Significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A)(iii) of the Act
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
Copies of the submission, all subsequent amendments, all written statements with respect to the proposed rule change that are filed with the Commission, and all written communications relating to the proposed rule change between the Commission and any person, other than those that may be withheld from the public in accordance with the provisions of 5 U.S.C. 552, will be available for website viewing and printing in the Commission's Public Reference Room, 100 F Street NE, Washington, DC 20549, on official business days between the hours of 10 a.m. and 3 p.m. Copies of the filing also will be available for inspection and copying at the principal office of the Exchange. All comments received will be posted without change. Persons submitting comments are cautioned that we do not redact or edit personal identifying information from comment submissions. You should submit only information that you wish to make available publicly. All submissions should refer to File Number SR-BX-2018-048 and should be submitted on or before November 20, 2018.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to delete the current rules on arbitration (“Current Arbitration Rules”), under Chapter 18, and incorporate by reference The Nasdaq Stock Market LLC's (“Nasdaq”) rules on arbitration at General 6 (“Proposed Arbitration Rules”), into General 6 of the Exchange's rulebook's (“Rulebook”) shell structure.
The text of the proposed rule change is available on the Exchange's website at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Exchange proposes to delete the rules on arbitration, currently under Chapter 18, and incorporate by reference the Nasdaq rules on arbitration at General 6 of Nasdaq's rulebook into General 6 of the Exchange's Rulebook.
The Exchange adopted the Current Arbitration Rules to ensure a fair and efficient manner in which to handle any dispute, claim or controversy arising out of, or in connection with, the business of any Member of the Exchange. To help administer the process of dispute resolution, the Exchange and FINRA are parties to a Regulatory Contract, pursuant to which FINRA has agreed to perform certain functions and provide access to certain services, including: Member regulation and registration; non-real time market surveillance; examinations and investigations; and dispute resolution. FINRA currently operates the largest securities dispute resolution forum in the United States,
Because the Affiliated Exchanges are also parties to similar Regulatory Contracts with FINRA that make their members and associated persons of such members subject to the FINRA Code of Arbitration Procedure, the Exchange believes it is pertinent that a common set of rules on arbitration be included in the General section of the Rulebook's shell. Nasdaq completed this process recently
Therefore, the Exchange will incorporate by reference the Proposed Arbitration Rules in “General 6 Arbitration” of the shell's “General Rules” section.
The relocation and harmonization of the arbitration rules is part of the Exchange's continued effort to promote efficiency and conformity of its processes with those of its Affiliated Exchanges.
ISE will continue to file proposed rule changes to amend its General 6 Rules until such time as it receives an exemption from the Securities and Exchange Commission, pursuant to its authority under Section 36 of the Exchange Act of 1934 (“Act”) and Rule 0-12
The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act. The proposed changes do not impose a burden on competition because, as previously stated, they are (i) of a non-substantive nature, (ii) intended to harmonize the structure of the Exchange's rules with those of its Affiliated Exchanges, and (iii) intended to organize the Rulebook in a way that it will ease the Members' navigation and reading of the rules across the Affiliated Exchanges.
No written comments were either solicited or received.
Because the foregoing proposed rule change does not: (i) Significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A)(iii) of the Act
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
Copies of the submission, all subsequent amendments, all written statements with respect to the proposed rule change that are filed with the Commission, and all written communications relating to the proposed rule change between the Commission and any person, other than those that may be withheld from the public in accordance with the provisions of 5 U.S.C. 552, will be available for website viewing and printing in the Commission's Public Reference Room, 100 F Street NE, Washington, DC 20549, on official business days between the hours of 10 a.m. and 3 p.m. Copies of the filing also will be available for inspection and copying at the principal office of the Exchange. All comments received will be posted without change. Persons submitting comments are cautioned that we do not redact or edit personal
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to delete the current rules on arbitration (“Current Arbitration Rules”), under Chapter 18, and incorporate by reference The Nasdaq Stock Market LLC's (“Nasdaq”) rules on arbitration at General 6 (“Proposed Arbitration Rules”), into General 6 of the Exchange's rulebook's (“Rulebook”) shell structure.
The text of the proposed rule change is available on the Exchange's website at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Exchange proposes to delete the rules on arbitration, currently under Chapter 18, and incorporate by reference the Nasdaq rules on arbitration at General 6 of Nasdaq's rulebook into General 6 of the Exchange's Rulebook.
The Exchange adopted the Current Arbitration Rules to ensure a fair and efficient manner in which to handle any dispute, claim or controversy arising out of, or in connection with, the business of any Member of the Exchange. To help administer the process of dispute resolution, the Exchange and FINRA are parties to a Regulatory Contract, pursuant to which FINRA has agreed to perform certain functions and provide access to certain services, including: member regulation and registration; non-real time market surveillance; examinations and investigations; and dispute resolution. FINRA currently operates the largest securities dispute resolution forum in the United States,
Because the Affiliated Exchanges are also parties to similar Regulatory Contracts with FINRA that make their members and associated persons of such members subject to the FINRA Code of Arbitration Procedure, the Exchange believes it is pertinent that a common set of rules on arbitration be included in the General section of the Rulebook's shell. Nasdaq completed this process recently
Therefore, the Exchange will incorporate by reference the Proposed Arbitration Rules in “General 6 Arbitration” of the shell's “General Rules” section.
The relocation and harmonization of the arbitration rules is part of the Exchange's continued effort to promote efficiency and conformity of its processes with those of its Affiliated Exchanges.
MRX will continue to file proposed rule changes to amend its General 6 Rules until such time as it receives an exemption from the Securities and Exchange Commission, pursuant to its authority under Section 36 of the Exchange Act of 1934 (“Act”) and Rule 0-12
The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act. The proposed changes do not impose a burden on competition because, as previously stated, they are (i) of a non-substantive nature, (ii) intended to harmonize the structure of the Exchange's rules with those of its Affiliated Exchanges, and (iii) intended to organize the Rulebook in a way that it will ease the Members' navigation and reading of the rules across the Affiliated Exchanges.
No written comments were either solicited or received.
Because the foregoing proposed rule change does not: (i) Significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A)(iii) of the Act
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
Copies of the submission, all subsequent amendments, all written statements with respect to the proposed rule change that are filed with the Commission, and all written communications relating to the proposed rule change between the Commission and any person, other than those that may be withheld from the public in accordance with the provisions of 5 U.S.C. 552, will be available for website viewing and printing in the Commission's Public Reference Room, 100 F Street NE, Washington, DC 20549, on official business days between the hours of 10 a.m. and 3 p.m. Copies of the filing also will be available for inspection and copying at the principal office of the Exchange. All comments received will be posted without change. Persons submitting comments are cautioned that we do not redact or edit personal identifying information from comment submissions. You should submit only information that you wish to make available publicly. All submissions should refer to File Number SR-MRX-2018-32 and should be submitted on or before November 20, 2018.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
Cboe BZX Exchange, Inc. (the “Exchange” or “BZX Options”) proposes to permit the listing and trading of P.M.-settled series on certain broad-based index options on a pilot basis.
The text of the proposed rule change is also available on the Exchange's website (
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these
The proposed rule change permits the listing and trading of P.M.-settled series on certain broad-based index options on a pilot basis.
Proposed Rule 29.11(a)(6) permits the listing and trading, in addition to A.M.-settled XSP options, of P.M.-settled XSP options with third-Friday-of-the-month expiration dates on a pilot basis for an initial period of 12 months from the date of approval of this proposed rule change. XSP options are A.M.-settled pursuant to the generic listing criteria in Rule 29.11(a)(5). The Exchange believes permitting the trading of XSP options on a P.M.-settled basis will encourage greater trading in XSP options.
Other than settlement and closing time on the last trading day (as discussed below), contract terms for P.M.-settled XSP options will be the same as the A.M.-settled XSP options. The proposed contract would use a $100 multiplier. The minimum trading increments, strike price intervals, and expirations would be the same as the A.M.-settled XSP option series. P.M.-settled XSP options would have European-style exercise. The Exchange will also have flexibility to open for trading additional series in response to customer demand.
The proposed rule change amends Rule 29.10(a) to state that, on their last trading day, transactions in P.M.-settled XSP options may be effected on the Exchange between the hours of 9:30 a.m. and 4:00 p.m. Eastern time (as opposed to the normal trading hours for non-expiring P.M.-settled XSP options, which are from 9:30 a.m. to 4:15 p.m. Eastern time). XSP options are typically priced in the market based on corresponding futures values. The primary listing markets for the component securities that comprise the S&P 500 Index close trading in those securities at 4:00 p.m. The primary listing exchanges for the component securities disseminate closing prices of the component securities, which are used to calculate the exercise settlement value of the S&P 500 Index. The Exchange believes that, under normal trading circumstances, the primary listing markets have sufficient bandwidth to prevent any data queuing that would cause any trades that are executed prior to the closing time from being reported after 4:00 p.m. Despite the fact that the exercise settlement value will be fixed at or soon after 4:00 p.m., if the Exchange did not close trading in expiring P.M.-settled XSP options at 4:00 p.m. on their last trading day, trading in expiring P.M.-settled XSP options would continue for an additional fifteen minutes until 4:15 p.m. and would not be able to be priced on corresponding futures values, but rather the known cash value. At the same time, the prices of non-expiring P.M.-settled XSP option series would continue to move and be priced in response to changes in corresponding futures prices.
A potential pricing divergence could occur between 4:00 p.m. and 4:15 p.m. on the final trading day in expiring P.M.-settled XSP options (
If the Exchange were to propose an extension of the XSPPM Pilot Program or should the Exchange propose to make the XSPPM Pilot Program permanent, the Exchange would submit a filing proposing such amendments to the XSPPM Pilot Program. Further, any positions established under the XSPPM Pilot Program would not be impacted by the expiration of the XSPPM Pilot Program. For example, if the Exchange lists a P.M.-settled XSP option that expires after the XSPPM Pilot Program expires (and is not extended), then those positions would continue to exist. If the pilot were not extended, then the positions could continue to exist. However, any further trading in those series would be restricted to transactions where at least one side of the trade is a closing transaction.
As part of the XSPPM Pilot Program, the Exchange will submit a pilot report to the Commission at least two months prior to the expiration date of the pilot. This annual report will contain an analysis of volume, open interest, and trading patterns. The analysis would examine trading in the proposed option product as well as trading in the securities that comprise the S&P 500 Index. In addition, for series that exceed certain minimum open interest parameters, the annual report will provide analysis of index price volatility and, if needed, share trading activity.
The annual report will contain the following volume and open interest data:
(1) Monthly volume aggregated for all trades;
(2) monthly volume aggregated by expiration date;
(3) monthly volume for each individual series;
(4) month-end open interest aggregated for all series;
(5) month-end open interest aggregated by expiration date; and
(6) month-end open interest for each individual series.
The annual report will also contain the information noted above for expiration Friday A.M.-settled XSP option series, if applicable, for the period covered in the annual report. In addition to the annual report, the Exchange will provide the Commission with interim reports of the information listed in (1) through (6) above.
In the annual report, the annual report would contain the following analysis of trading patterns in expiration Friday, P.M.-settled XSP option series in the XSPPM Pilot Program:
(1) A time series analysis of open interest; and
(2) an analysis of the distribution of trade sizes.
Also, for series that exceed certain minimum parameters, the annual report will also contain the following analysis related to index price changes and, if needed, underlying share trading volume at the close on expiration Fridays:
(1) A comparison of index price changes at the close of trading on a given expiration Friday with comparable price changes from a control sample. The data will include a calculation of percentage price changes for various time intervals and compare that information to the respective control sample. Raw percentage price change data as well as percentage price change data normalized for prevailing market volatility, as measured by an appropriate index as agreed by the Commission and the Exchange, would be provided; and
(2) a calculation of share volume for a sample set of the component securities representing an upper limit on share trading that could be attributable to expiring in-the-money series. The data, if needed, will include a comparison of the calculated share volume for securities in the sample set to the average daily trading volumes of those securities over a sample period.
The minimum open interest parameters, control sample, time intervals, method for randomly selecting the component securities, and sample periods would be determined by the Exchange and the Commission.
Additionally, the Exchange will provide the Commission with any additional data or analyses the Commission requests because it deems such data or analyses necessary to determine whether the XSPPM Pilot Program is consistent with the Exchange Act. The Exchange will make public all data and analyses it submits to the Commission under the XSPPM Pilot Program.
Other exchanges currently have pilots that permit P.M.-settled index options.
The proposed rule change permits the listing and trading, on a pilot basis, of P.M.-settled options on broad-based indexes with nonstandard expiration dates for an initial period of 12 months from the date of approval of this proposed rule change. The Nonstandard Expirations Pilot Program will permit both Weeklys and EOMs as discussed below. Contract terms for the Weekly and EOM expirations will be similar to those of the A.M.-settled broad-based index options, except that the Weekly and EOM expirations will be P.M.-settled.
Proposed Rule 29.11(j)(1) permits the Exchange to open for trading Weeklys on any broad-based index eligible for standard options trading to expire on any Monday, Wednesday, or Friday (other than the third Friday-of-the-month or days that coincide with an EOM). Weeklys will be subject to all provisions of Rule 29.11 and will be treated the same as options on the same underlying index that expire on the third Friday of the expiration month. However, Weeklys will be P.M.-settled, and new Weekly series may be added up to and including on the expiration date for an expiring Weekly.
The maximum number of expirations that may be listed for each Weekly (
Proposed Rule 29.11(a)(2) [sic] permits the Exchange to open for trading EOMs on any broad-based index eligible for standard options trading to expire on the last trading day of the month. EOMs will be subject to all provisions of Rule 29.11 and treated the same as options on the same underlying index that expire on the third Friday of the expiration month. However, EOMs will be P.M.-settled, and new series of EOMs may be added up to and including on the expiration date for an expiring EOM.
The maximum number of expirations that may be listed for EOMs in a given class is the same as the maximum number of expirations permitted in Rule 29.11(a)(3) for standard options on the same broad-based index.
The proposed rule change amends Rule 29.11(c)(5)(C) to provide that the lowest strike interval for series of XSP options listed under the Nonstandard Expirations Pilot Program will be $0.50. With respect to XSP, this is consistent with the minimum strike interval for XSP options listed under the Short Term Series Program.
Weeklys and EOMs will be subject to the same rules that currently govern the trading of standard monthly broad-based index options, including sales practice rules, margin requirements, and floor trading procedures. Contract terms for Weeklys and EOMs will be the same as those for standard monthly broad-based index options. Since Weeklys and EOMs will be new types of series, and not a new class, the Exchange proposes that Weeklys and EOMs will be aggregated for any applicable reporting
As stated above, this proposed rule change establishes a Nonstandard Expirations Pilot Program for broad-based index options on a pilot basis, for an initial period of 12 months from the date of approval of this proposed rule change. If the Exchange were to propose an extension of the Nonstandard Expirations Pilot Program or should the Exchange propose to make it permanent, the Exchange would submit a filing proposing such amendments. Further, any positions established under the Nonstandard Expirations Pilot Program would not be impacted by the expiration of the pilot. For example, if the Exchange lists a Weekly or EOM that expires after the Nonstandard Expirations Pilot Program expires (and is not extended), then those positions would continue to exist. However, any further trading in those series would be restricted to transactions where at least one side of the trade is a closing transaction.
As part of the Nonstandard Expirations Pilot Program, the Exchange will submit a pilot report to the Commission at least two months prior to the expiration date of the pilot (the “annual report”). The annual report will contain an analysis of volume, open interest, and trading patterns. In addition, for series that exceed certain minimum open interest parameters, the annual report will provide analysis of the index price volatility, and, if needed, share trading activity.
For all Weekly and EOM series, the annual report will contain the following volume and open interest data for each broad-based index overlying Weekly and EOM options:
(1) Monthly volume aggregated for all Weekly and EOM series;
(2) Volume in Weekly and EOM series aggregated by expiration date;
(3) Month-end open interest aggregated for all Weekly and EOM series;
(4) Month-end open interest for EOM series aggregated by expiration date and open interest for Weekly series aggregated by expiration date;
(5) Ratio of monthly aggregate volume in Weekly and EOM series to total monthly class volume; and
(6) Ratio of month-end open interest in EOM series to total month-end class open interest and ratio of open interest in each Weekly series to total class open interest.
In addition, the annual report will contain the information noted above for standard expiration Friday, A.M.-settled series, if applicable, for the period covered in the annual report as well as for the six-month period prior to the initiation of the pilot.
Upon request by the SEC, the Exchange will provide a data file containing:
(1) Weekly and EOM option volume data aggregated by series, and
(2) Weekly open interest for each expiring series and EOM month-end open interest for expiring series.
In the annual report, the Exchange also proposes to identify Weekly and EOM trading patterns by undertaking a time series analysis of open interest in Weekly and EOM series aggregated by expiration date compared to open interest in near-term standard expiration Friday A.M.-settled series in order to determine whether users are shifting positions from standard series to Weekly and EOM series. In addition, to the extent that data on other weekly or monthly P.M.-settled products from other exchanges is publicly available, the report will also compare open interest with these options in order to determine whether users are shifting positions from other weekly or monthly P.M.-settled products to the Weekly and EOM series. Declining open interest in standard series or the weekly or monthly P.M.-settled products of other exchanges accompanied by rising open interest in Weekly and EOM series would suggest that users are shifting positions.
For each Weekly and EOM expiration that has open interest that exceeds certain minimum thresholds, the annual report will contain the following analysis related to index price changes and, if needed, underlying share trading volume at the close on expiration dates:
(1) A comparison of index price changes at the close of trading on a given expiration date with comparable price changes from a control sample. The data will include a calculation of percentage price changes for various time intervals and compare that information to the respective control sample. Raw percentage price change data as well as percentage price change data normalized for prevailing market volatility, as measured by an appropriate index agreed to by the Commission and the Exchange, will be provided; and
(2) If needed, a calculation of share volume for a sample set of the component securities representing an upper limit on share trading that could be attributable to expiring in-the-money Weekly and EOM series. The data, if needed, will include a comparison of the calculated share volume for securities in the sample set to the average daily trading volumes of those securities over a sample period.
The minimum open interest parameters, control sample, time intervals, method for selecting the component securities, and sample periods will be determined by the Exchange and the Commission.
Additionally, the Exchange will provide the Commission with any additional data or analyses the Commission requests because it deems such data or analyses necessary to determine whether the Nonstandard Expirations Pilot Program is consistent with the Exchange Act. The Exchange will make public all data and analyses it submits to the Commission under the Nonstandard Expirations Pilot Program. Other exchanges currently have pilots that have weekly and end-of-month expirations.
Precedent exists for P.M.-settled broad-based index options, as other options exchanges list P.M.-settled broad-based index options.
The Exchange notes that P.M.-settled options predominate in the over-the-counter (“OTC”) market, and the Exchange is not aware of any adverse effects in the stock market attributable to the P.M.-settlement feature. The
The adoption of P.M.-settled options on an exchange that lists A.M.-settled options in the same class would provide greater spread opportunities. This manner of trading in different products allows a market participant to take advantage of the different expiration times, providing expanded trading opportunities. In the options market currently, market participants regularly trade similar or related products in conjunction with each other, which contributes to overall market liquidity.
The Exchange represents it has an adequate surveillance program in place for index options. The Exchange is a member of the Intermarket Surveillance Group (“ISG”), which is comprised of an international group of exchanges, market centers, and market regulators. The purpose of ISG is to provide a framework for the sharing of information and the coordination of regulatory efforts among exchanges trading securities and related products to address potential intermarket manipulations and trading abuses. ISG plays a crucial role in information sharing among markets that trade securities, options on securities, security futures products, and futures and options on broad-based security indexes. A list of identifying current ISG members is available at
The Exchange has analyzed its capacity and represents that it believes the Exchange and OPRA have the necessary systems capacity to handle the additional traffic associated with the listing of P.M.-settled XSP and Weekly/EOM option series up to the proposed number of possible expirations and strike prices. The Exchange believes any additional traffic that would be generated from the introduction of P.M.-settled XSP and Weekly/EOM options series will be manageable. The Exchange believes its Members will not have a capacity issue as a result of this proposed rule change. The Exchange also represents that it does not believe this expansion will cause fragmentation of liquidity. The Exchange will monitor the trading volume associated with the additional options series listed as a result of this proposed rule change and the effect (if any) of these additional series on market fragmentation and on the capacity of the Exchange's automated systems.
P.M.-settled options would be subject to all provisions of Rule 29.11. P.M.-settled options would be subject to the same rules that govern the trading of A.M.-settled options overlying the same indexes, including sales practice rules, margin requirements, and floor trading procedures. P.M.-settled options will be subject to the margin requirements set forth in Chapter 28 and the position limits set forth in Rule 29.5. Chapter 28 imposes the margin requirements of either Cboe Options or the New York Stock Exchange on Exchange Options Members. Similarly, Rule 29.5 imposes position (and exercise) limits for broad-based index options of Cboe Options on Exchange Options Members. Since P.M.-settled options will be a new type of series, and not a new class, the Exchange proposes that the P.M.-settled options will be aggregated for any applicable reporting and other requirements.
The Exchange believes the proposed rule change is consistent with the Securities Exchange Act of 1934 (the “Act”) and the rules and regulations thereunder applicable to the Exchange and, in particular, the requirements of Section 6(b) of the Act.
The Exchange believes the proposed rule change will attract order flow to the Exchange, increase the variety of listed options to investors, and provide a valuable hedge tool to investors. The Exchange believes the proposed rule change will also remove impediments to and perfect the mechanism of a free and open market, and in general protect investors by expanding the ability of investors to hedge risks against market movements stemming from economic releases or market events that occur during the month and at the end of the month. Accordingly, the Exchange believes that P.M.-settled options will create greater trading and hedging opportunities and flexibility, and provide customers with the ability to more closely tailor their investment objectives.
The Commission has previously stated that when cash-settled index options were first introduced in the 1980s, they generally utilized closing-price settlement procedures (
However, the Exchange believes that the above concerns that have led to the transition to A.M. settlement for index derivatives have been largely mitigated. It believes that expiration pressure in the underlying cash markets at the close has been greatly reduced with the advent of multiple primary listing and unlisted trading privilege markets, and that trading is now widely dispersed among many market centers. Additionally, the Exchange notes that opening procedures in the 1990s were deemed acceptable to mitigate one-sided order flow driven by index option expiration and that the New York Stock Exchange and Nasdaq Stock Market, LLC each use an automated closing cross procedures and has a closing order type that facilitates orderly closings. These closing procedures on the exchanges on which the components of the S&P 500 Index trade are well-equipped to mitigate imbalance pressure at the close. In addition, after-hours trading now provides market participants with an alternative to help offset market-on-close imbalances.
Other exchanges currently have pilots that permit P.M.-settled index options
The proposed rule change to permit transactions on the Exchange in P.M.-settled XSP and Weekly/EOM options on their last trading day between the hours of 9:30 a.m. and 4:00 p.m. Eastern time (as opposed to the normal trading hours for non-expiring P.M.-settled XSP and Weekly/EOM options, which are from 9:30 a.m. to 4:15 p.m. Eastern time) will prevent potential pricing divergence that could occur between 4:00 p.m. and 4:15 p.m. on the final trading day in expiring P.M.-settled XSP options. Without closing expiring contracts at 4:00 p.m., it is foreseeable that Market-Makers would react by widening spreads in order to compensate for the additional risk. Therefore, the Exchange believes that, in order to mitigate potential investor confusion and the potential for increased costs to investors, it is appropriate to cease trading in the expiring P.M.-settled XSP and Weekly/EOM contracts at 4:00 p.m. The Exchange does not believe the proposed change will impact volatility on the underlying cash market at the close on third Fridays. Further, the other options exchanges close trading in certain options on the last trading day for certain classes.
The Exchange has analyzed its capacity and represents that it believes the Exchange and OPRA have the necessary systems capacity to handle the additional traffic associated with the listing of P.M.-settled options. The Exchange believes any additional traffic that may be generated from the introduction of P.M.-settled options will be manageable. The Exchange represents that it has in place adequate surveillance procedures to monitor trading in these options thereby helping to ensure the maintenance of a fair and orderly market.
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. P.M.-settled options would be available for trading on the Exchange to all market participants. The Exchange believes the proposed rule change will increase the variety of listed options to investors, and provide valuable hedge tools to investors. The listing of P.M.-settled options will enhance competition by providing investors with an additional investment vehicle, through which investors can gain and hedge exposure to the stocks that compose the applicable broad-based indexes. Additionally, markets participants are welcome to become Members and trade at the Exchange if they determine this proposed rule change has made the Exchange more attractive or favorable. Further, this product could offer a competitive alternative to other existing investment products that seek to allow Members to gain broad market exposure. Finally, all options exchanges are free to compete by listing and trading index options that are P.M.-settled. Other exchanges currently have pilots that permit P.M.-settled index options
The proposed rule change to permit transactions on the Exchange in P.M.-settled XSP and Weekly/EOM options on their last trading day between the hours of 9:30 a.m. and 4:00 p.m. Eastern time (as opposed to the normal trading hours for non-expiring P.M.-settled XSP and Weekly/EOM options, which are from 9:30 a.m. to 4:15 p.m. Eastern time) will prevent potential pricing divergence that could occur between 4:00 p.m. and 4:15 p.m. on the final trading day in expiring P.M.-settled XSP and Weekly/EOM options. Without closing expiring contracts at 4:00 p.m., it is foreseeable that Market-Makers would react by widening spreads in order to compensate for the additional risk. Therefore, the Exchange believes that, in order to mitigate potential investor confusion and the potential for increased costs to investors, it is appropriate to cease trading in the expiring P.M.-settled XSP and Weekly/EOM contracts at 4:00 p.m. The Exchange does not believe the proposed change will impact volatility on the underlying cash market at the close on third Fridays. Further, the other options exchanges close trading in certain options on the last trading day for certain classes.
The Exchange believes that the proposed rule change will relieve any burden on, or otherwise promote, competition, as the rules are substantially the same as those of other options exchanges, as noted above.
The Exchange neither solicited nor received comments on the proposed rule change.
Within 45 days of the date of publication of this notice in the
A. By order approve or disapprove such proposed rule change, or
B. institute proceedings to determine whether the proposed rule change should be disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to delete the current rules on arbitration (“Current Arbitration Rules”), under Rule 950, and incorporate by reference The Nasdaq Stock Market LLC's (“Nasdaq”) rules on arbitration at General 6 (“Proposed Arbitration Rules”), into General 6 of the Exchange's rulebook's (“Rulebook”) shell structure.
The text of the proposed rule change is available on the Exchange's website at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Exchange proposes to delete the rules on arbitration, currently under Rule 950, and incorporate by reference the Nasdaq rules on arbitration at General 6 of Nasdaq's rulebook into General 6 of the Exchange's Rulebook.
The Exchange adopted the Current Arbitration Rules to ensure a fair and efficient manner in which to handle any dispute, claim or controversy arising out of, or in connection with, the business of any Member of the Exchange. To help administer the process of dispute resolution, the Exchange and FINRA are parties to a Regulatory Contract, pursuant to which FINRA has agreed to perform certain functions and provide access to certain services, including: Member regulation and registration; non-real time market surveillance; examinations and investigations; and dispute resolution. FINRA currently operates the largest securities dispute resolution forum in the United States,
Because the Affiliated Exchanges are also parties to similar Regulatory Contracts with FINRA that make their members and associated persons of such members subject to the FINRA Code of Arbitration Procedure, the Exchange believes it is pertinent that a common set of rules on arbitration be included in the General section of the Rulebook's shell. Nasdaq completed this process recently
Therefore, the Exchange will incorporate by reference the Proposed Arbitration Rules in “General 6 Arbitration” of the shell's “General Equity and Options Rules” section.
The relocation and harmonization of the arbitration rules is part of the Exchange's continued effort to promote efficiency and conformity of its processes with those of its Affiliated Exchanges.
PHLX will continue to file proposed rule changes to amend its General 6 Rules until such time as it receives an exemption from the Securities and Exchange Commission, pursuant to its authority under Section 36 of the Exchange Act of 1934 (“Act”) and Rule 0-12
The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act. The proposed changes do not impose a burden on competition because, as previously stated, they are (i) of a non-substantive nature, (ii) intended to harmonize the structure of the Exchange's rules with those of its Affiliated Exchanges, and (iii) intended to organize the Rulebook in a way that it will ease the Members' navigation and reading of the rules across the Affiliated Exchanges.
No written comments were either solicited or received.
Because the foregoing proposed rule change does not: (i) Significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A)(iii) of the Act
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
All submissions should refer to File Number SR-Phlx-2018-62. This file number should be included on the subject line if email is used. To help the Commission process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's internet website (
Copies of the submission, all subsequent amendments, all written statements with respect to the proposed rule change that are filed with the Commission, and all written communications relating to the proposed rule change between the Commission and any person, other than those that may be withheld from the public in accordance with the provisions of 5 U.S.C. 552, will be available for website viewing and printing in the Commission's Public Reference Room, 100 F Street NE, Washington, DC 20549, on official business days between the hours of 10 a.m. and 3 p.m. Copies of the filing also will be available for inspection and copying at the principal office of the Exchange. All comments received will be posted without change. Persons submitting comments are cautioned that we do not redact or edit personal identifying information from comment submissions. You should submit only information that you wish to make available publicly. All submissions should refer to File Number SR-Phlx-
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
U.S. Small Business Administration.
Notice.
This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the State of Florida (FEMA-4399-DR), dated 10/23/2018.
Issued on 10/23/2018.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW, Suite 6050, Washington, DC 20416, (202) 205-6734.
Notice is hereby given that as a result of the President's major disaster declaration on 10/23/2018, Private Non-Profit organizations that provide essential services of a governmental nature may file disaster loan applications at the address listed above or other locally announced locations.
The following areas have been determined to be adversely affected by the disaster:
The Interest Rates are:
The number assigned to this disaster for physical damage is 157808 and for economic injury is 157810.
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995, FMCSA announces its plan to submit the Information Collection Request (ICR) described below to the Office of Management and Budget (OMB) for review and approval. FMCSA requests approval to revise and renew an ICR titled, “Commercial Driver Licensing and Test Standards,” due to, in part, a decrease in the number of commercial driver's license records and the addition of one information collection item: “Driver completion of knowledge and skills tests.” This ICR is needed to ensure that drivers, motor carriers and the States are complying with notification and recordkeeping requirements for information related to testing, licensing, violations, convictions and disqualifications and that the information is accurate, complete and transmitted and recorded within certain time periods as required by the Commercial Motor Vehicle Safety Act of 1986 (CMVSA), as amended.
Please send your comments by November 29, 2018. OMB must receive your comments by this date in order to act quickly on the ICR.
All comments should reference Federal Docket Management System (FDMS) Docket Number FMCSA-2018-0159. Interested persons are invited to submit written comments on the proposed information collection to the Office of Information and Regulatory Affairs, Office of Management and Budget. Comments should be addressed to the attention of the Desk Officer, Department of Transportation/Federal Motor Carrier Safety Administration, and sent via electronic mail to
Mr. Selden Fritschner, Senior Transportation Specialist, Office of Safety Programs, Commercial Driver's License Division (MC-ESL), Department of Transportation, Federal Motor Carrier Safety Administration, 6th Floor, West Building, 1200 New Jersey Avenue SE, Washington, DC 20590-0001. Telephone: 202-366-0677; Email Address:
Information collection tasks and associated burden hours are as follows:
For a detailed history of regulatory developments in 49 CFR parts 383 and 384 to implement the mandates in the CMVSA, see the supporting statement in the docket for this matter.”
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Notice of final disposition.
FMCSA announces its decision to exempt 13 individuals from the vision requirement in the Federal Motor Carrier Safety Regulations (FMCSRs) to operate a commercial motor vehicle (CMV) in interstate commerce. They are unable to meet the vision requirement in one eye for various reasons. The exemptions enable these individuals to operate CMVs in interstate commerce without meeting the vision requirement in one eye.
The exemptions were applicable on August 17, 2018. The exemptions expire on August 17, 2020.
Ms. Christine A. Hydock, Chief, Medical Programs Division, (202) 366-4001,
To view comments, as well as any documents mentioned in this notice as being available in the docket, go to
In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. DOT posts these comments, without edit, including any personal information the commenter provides, to
On July 17, 2018, FMCSA published a notice announcing receipt of applications from 13 individuals requesting an exemption from vision requirement in 49 CFR 391.41(b)(10) and requested comments from the public (83 FR 33292). The public comment period ended on August 16, 2018, and no comments were received.
FMCSA has evaluated the eligibility of these applicants and determined that granting the exemptions to these individuals would achieve a level of safety equivalent to or greater than the level that would be achieved by complying with the current regulation 49 CFR 391.41(b)(10).
The physical qualification standard for drivers regarding vision found in 49 CFR 391.41(b)(10) states that a person is physically qualified to driver a CMV if that person has distant visual acuity of at least 20/40 (Snellen) in each eye without corrective lenses or visual acuity separately corrected to 20/40 (Snellen) or better with corrective lenses, distant binocular acuity of a least 20/40 (Snellen) in both eyes with or without corrective lenses, field of vision of at least 70° in the horizontal meridian in each eye, and the ability to recognize the colors of traffic signals and devices showing red, green, and amber.
FMCSA received no comments in this proceeding.
Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption for up to five years from the vision standard in 49 CFR 391.41(b)(10) if the exemption is likely to achieve an equivalent or greater level of safety than would be achieved without the exemption. The exemption allows applicants to operate CMVs in
The Agency's decision regarding these exemption applications is based on medical reports about the applicants' vision as well as their driving records and experience driving with the vision deficiency. The qualifications, experience, and medical condition of each applicant were stated and discussed in detail in the July 17, 2018,
FMCSA recognizes that some drivers do not meet the vision requirement but have adapted their driving to accommodate their limitation and demonstrated their ability to drive safely. The 13 exemption applicants listed in this notice are in this category. They are unable to meet the vision requirement in one eye for various reasons, including amblyopia, complete loss of vision, corneal scar, irregularly shaped pupil, macular myelinated nerve fibers, macular scar, optic nerve damage, posterior staphyloma, prosthetic eye, and retinal detachment. In most cases, their eye conditions were not recently developed. Nine of the applicants were either born with their vision impairments or have had them since childhood. The four individuals that sustained their vision conditions as adults have had it for a range of 6 to 18 years. Although each applicant has one eye which does not meet the vision requirement in 49 CFR 391.41(b)(10), each has at least 20/40 corrected vision in the other eye, and in a doctor's opinion, has sufficient vision to perform all the tasks necessary to operate a CMV.
Doctors' opinions are supported by the applicants' possession of a valid license to operate a CMV. By meeting State licensing requirements, the applicants demonstrated their ability to operate a CMV, with their limited vision in intrastate commerce, even though their vision disqualified them from driving in interstate commerce. We believe that the applicants' intrastate driving experience and history provide an adequate basis for predicting their ability to drive safely in interstate commerce. Intrastate driving, like interstate operations, involves substantial driving on highways on the interstate system and on other roads built to interstate standards. Moreover, driving in congested urban areas exposes the driver to more pedestrian and vehicular traffic than exists on interstate highways. Faster reaction to traffic and traffic signals is generally required because distances between them are more compact. These conditions tax visual capacity and driver response just as intensely as interstate driving conditions.
The applicants in this notice have driven CMVs with their limited vision in careers ranging for 4 to 78 years. In the past three years, no drivers were involved in crashes, and one driver was convicted of a moving violation in a CMV. All the applicants achieved a record of safety while driving with their vision impairment, demonstrating the likelihood that they have adapted their driving skills to accommodate their condition. As the applicants' ample driving histories with their vision deficiencies are good predictors of future performance, FMCSA concludes their ability to drive safely can be projected into the future.
Consequently, FMCSA finds that in each case exempting these applicants from the vision requirement in 49 CFR 391.41(b)(10) is likely to achieve a level of safety equal to that existing without the exemption.
The terms and conditions of the exemption are provided to the applicants in the exemption document and includes the following: (1) Each driver must be physically examined every year (a) by an ophthalmologist or optometrist who attests that the vision in the better eye continues to meet the standard in 49 CFR 391.41(b)(10) and (b) by a certified Medical Examiner who attests that the individual is otherwise physically qualified under 49 CFR 391.41; (2) each driver must provide a copy of the ophthalmologist's or optometrist's report to the Medical Examiner at the time of the annual medical examination; and (3) each driver must provide a copy of the annual medical certification to the employer for retention in the driver's qualification file, or keep a copy in his/her driver's qualification file if he/she is self-employed. The driver must also have a copy of the exemption when driving, for presentation to a duly authorized Federal, State, or local enforcement official.
During the period the exemption is in effect, no State shall enforce any law or regulation that conflicts with this exemption with respect to a person operating under the exemption.
Based upon its evaluation of the 13 exemption applications, FMCSA exempts the following drivers from the vision requirement, 49 CFR 391.41(b)(10), subject to the requirements cited above:
In accordance with 49 U.S.C. 31136(e) and 31315, each exemption will be valid for two years from the effective date unless revoked earlier by FMCSA. The exemption will be revoked if the following occurs: (1) The person fails to comply with the terms and conditions of the exemption; (2) the exemption has resulted in a lower level of safety than was maintained prior to being granted; or (3) continuation of the exemption would not be consistent with the goals and objectives of 49 U.S.C. 31136 and 31315.
Federal Railroad Administration (FRA), Department of Transportation (DOT).
Notice of information collection; request for comment.
Under the Paperwork Reduction Act of 1995 (PRA), this notice announces that FRA is forwarding the Information Collection Requests (ICRs) abstracted below to the Office of Management and Budget (OMB) for review and comment. The ICRs describe the information collections and their expected burden. On August 1, 2018, FRA published a notice providing a 60-day period for public comment on the ICRs.
Interested persons are invited to submit comments on or before November 29, 2018.
Submit written comments on the ICRs to the Office of Information
Mr. Robert Brogan, Information Collection Clearance Officer, Office of Railroad Safety, Regulatory Analysis Division, RRS-21, Federal Railroad Administration, 1200 New Jersey Avenue SE, Room W33-497, Washington, DC 20590 (telephone: (202) 493-6292); or Ms. Kim Toone, Information Collection Clearance Officer, Office of Administration, Office of Information Technology, RAD-20, Federal Railroad Administration, 1200 New Jersey Avenue SE, Room W34-212, Washington, DC 20590 (telephone: (202) 493-6132).
The PRA, 44 U.S.C. 3501-3520, and its implementing regulations, 5 CFR part 1320, require Federal agencies to issue two notices seeking public comment on information collection activities before OMB may approve paperwork packages.
Before OMB decides whether to approve these proposed collections of information, it must provide 30 days for public comment. Federal law requires OMB to approve or disapprove paperwork packages between 30 and 60 days after the 30-day notice is published. 44 U.S.C. 3507(b)-(c); 5 CFR 1320.12(d);
The summaries below describe the ICRs that FRA will submit for OMB clearance as the PRA requires:
Title 49 CFR part 235 sets forth the specific conditions under which FRA will approve the modification or discontinuance of railroad signal systems. These regulations also describe the process that should be followed by a railroad to seek such an approval. The application process prescribed under 49 CFR part 235 enables FRA to obtain the necessary information to make logical and informed decisions concerning railroad requests to modify or discontinue signaling systems. Section 235.5 requires railroads to apply for FRA approval to discontinue or materially modify railroad signal systems. However, section 235.7 cites signal system changes that do not require FRA approval such as removal of an interlocking where a drawbridge has been permanently closed by the formal approval of another governmental agency. Section 235.8 allows railroads to seek relief from the requirements in 49 CFR part 236. Sections 235.10, 235.12, and 235.13 explain where the application must be submitted, what information must be included, what the format should be, and who is authorized to sign the application. FRA provides public notice concerning applications for relief and allows individuals and organizations to protest the granting of an application for relief. Section 235.20 describes the protest process, including essential information that must accompany the protest, the address for filing the protest, the time limit for filing the protest, and the requirement that a person requesting a public hearing explain why written statements cannot be used to explain his or her position.
Title 49 CFR part 236 contains FRA's signal system requirements. Section 236.110 requires that the results of signal system tests required under §§ 236.102 through 236.109; 236.376 through 236.387; 236.576 and 236.577; and 236.586 through 236.589 be recorded on pre-printed forms provided by the railroad or by electronic means, subject to FRA approval. These forms show the name of the railroad, place and date of the test conducted, type of equipment tested, and results of the test. They also describe any repairs, replacements, and adjustments performed on the equipment that has been tested, and the condition in which the equipment was left. This section
Under 44 U.S.C. 3507(a) and 5 CFR 1320.5(b) and 1320.8(b)(3)(vi), FRA informs all interested parties that it may not conduct or sponsor, and a respondent is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
44 U.S.C. 3501-3520.
Maritime Administration, DOT.
Notice.
The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirements of the coastwise trade laws to allow the carriage of no more than twelve passengers for hire on vessels, which are three years old or more. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
Submit comments on or before November 29, 2018.
You may submit comments identified by DOT Docket Number MARAD-2018-0158 by any one of the following methods:
•
•
Bianca Carr, U.S. Department of Transportation, Maritime
As described by the applicant the intended service of the vessel YEMAYA is:
Please submit your comments, including the attachments, following the instructions provided under the above heading entitled
Go to the docket online at
Yes. Be aware that your entire comment, including your personal identifying information, will be made publicly available.
If you wish to submit comments under a claim of confidentiality, you should submit three copies of your complete submission, including the information you claim to be confidential business information, to the Department of Transportation, Maritime Administration, Office of Legislation and Regulations, MAR-225, W24-220, 1200 New Jersey Avenue SE, Washington, DC 20590. Include a cover letter setting forth with specificity the basis for any such claim and, if possible, a summary of your submission that can be made available to the public.
In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. DOT posts these comments, without edit, to
49 CFR 1.93(a), 46 U.S.C. 55103, 46 U.S.C. 12121
By Order of the Maritime Administrator.
Maritime Administration, DOT.
Notice.
The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirements of the coastwise trade laws to allow the carriage of no more than twelve passengers for hire on vessels, which are three years old or more. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
Submit comments on or before November 29, 2018.
You may submit comments identified by DOT Docket Number MARAD-2018-0161 by any one of the following methods:
•
•
Bianca Carr, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE, Room W23-453, Washington, DC 20590. Telephone 202-366-9309, Email
As described by the applicant the intended service of the vessel Y KNOT is:
Please submit your comments, including the attachments, following the instructions provided under the above heading entitled
Go to the docket online at
Yes. Be aware that your entire comment, including your personal identifying information, will be made publicly available.
If you wish to submit comments under a claim of confidentiality, you should submit three copies of your complete submission, including the information you claim to be confidential business information, to the Department of Transportation, Maritime Administration, Office of Legislation and Regulations, MAR-225, W24-220, 1200 New Jersey Avenue SE, Washington, DC 20590. Include a cover letter setting forth with specificity the basis for any such claim and, if possible, a summary of your submission that can be made available to the public.
In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. DOT posts these comments, without edit, to
49 CFR 1.93(a), 46 U.S.C. 55103, 46 U.S.C. 12121.
By Order of the Maritime Administrator.
Maritime Administration, DOT.
Notice.
The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirements of the coastwise trade laws to allow the carriage of no more than twelve passengers for hire on vessels, which are three years old or more. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
Submit comments on or before November 29, 2018.
You may submit comments identified by DOT Docket Number MARAD-2018-0162 by any one of the following methods:
•
•
Bianca Carr, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE, Room W23-453, Washington, DC 20590. Telephone 202-366-9309, Email
As described by the applicant the intended service of the vessel ONE LOVE is:
Please submit your comments, including the attachments, following the instructions provided under the above heading entitled
Go to the docket online at
Yes. Be aware that your entire comment, including your personal identifying information, will be made publicly available.
If you wish to submit comments under a claim of confidentiality, you should submit three copies of your complete submission, including the information you claim to be confidential business information, to the Department of Transportation, Maritime Administration, Office of Legislation and Regulations, MAR-225, W24-220, 1200 New Jersey Avenue SE, Washington, DC 20590. Include a cover letter setting forth with specificity the basis for any such claim and, if possible, a summary of your submission that can be made available to the public.
In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. DOT posts these comments, without edit, to
49 CFR 1.93(a), 46 U.S.C. § 55103, 46 U.S.C. § 12121.
By Order of the Maritime Administrator.
Maritime Administration, DOT.
Notice.
The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirements of the coastwise trade laws to allow the carriage of no more than twelve passengers for hire on vessels, which are three years old or more. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
Submit comments on or before November 29, 2018.
You may submit comments identified by DOT Docket Number MARAD-2018-0160 by any one of the following methods:
•
•
Bianca Carr, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE, Room W23-453, Washington, DC 20590. Telephone 202-366-9309, Email
As described by the applicant the intended service of the vessel MACONDO is:
Please submit your comments, including the attachments, following the
Go to the docket online at
Yes. Be aware that your entire comment, including your personal identifying information, will be made publicly available.
If you wish to submit comments under a claim of confidentiality, you should submit three copies of your complete submission, including the information you claim to be confidential business information, to the Department of Transportation, Maritime Administration, Office of Legislation and Regulations, MAR-225, W24-220, 1200 New Jersey Avenue SE, Washington, DC 20590. Include a cover letter setting forth with specificity the basis for any such claim and, if possible, a summary of your submission that can be made available to the public.
In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. DOT posts these comments, without edit, to
By Order of the Maritime Administrator.
Maritime Administration, DOT.
Notice.
The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirements of the coastwise trade laws to allow the carriage of no more than twelve passengers for hire on vessels, which are three years old or more. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
Submit comments on or before November 29, 2018.
You may submit comments identified by DOT Docket Number MARAD-2018-0159 by any one of the following methods:
•
•
Bianca Carr, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE, Room W23-453, Washington, DC 20590. Telephone 202-366-9309, Email
As described by the applicant the intended service of the vessel SHANGHAI MAC is:
Please submit your comments, including the attachments, following the instructions provided under the above heading entitled
Go to the docket online at
Yes. Be aware that your entire comment, including your personal identifying information, will be made publicly available.
If you wish to submit comments under a claim of confidentiality, you should submit three copies of your complete submission, including the information you claim to be confidential business information, to the Department of Transportation, Maritime Administration, Office of Legislation and Regulations, MAR-225, W24-220, 1200 New Jersey Avenue SE, Washington, DC 20590. Include a cover letter setting forth with specificity the basis for any such claim and, if possible, a summary of your submission that can be made available to the public.
In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. DOT posts these comments, without edit, to
By Order of the Maritime Administrator.
Office of Foreign Assets Control, Treasury.
Notice.
The Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing the names of one or more persons and vessels that have been placed on OFAC's Specially Designated Nationals and Blocked Persons List based on OFAC's determination that one or more applicable legal criteria were satisfied. All property and interests in property subject to U.S. jurisdiction of these persons and these vessels are blocked, and U.S. persons are generally prohibited from engaging in transactions with them.
See
OFAC: Associate Director for Global Targeting, tel.: 202-622-2420; Assistant Director for Sanctions Compliance & Evaluation, tel.: 202-622-2490; Assistant Director for Licensing, tel.: 202-622-2480; or the Department of the Treasury's Office of the General Counsel: Office of the Chief Counsel (Foreign Assets Control), tel.: 202-622-2410.
The Specially Designated Nationals and Blocked Persons List and additional information concerning OFAC sanctions programs are available on OFAC's website (
On October 25, 2018, OFAC determined that the property and interests in property subject to U.S. jurisdiction of the following persons and the following vessels subject to U.S. jurisdiction are blocked pursuant to the relevant sanctions authority listed below.
1. TAN, Wee Beng, 51 Siang Kuang Avenue, Singapore; DOB 14 Feb 1977; Gender Male; Secondary sanctions risk: North Korea Sanctions Regulations, sections 510.201 and 510.210; Director of Wee Tiong (S) Pte Ltd; Managing Director of WT Marine Pte Ltd (individual) [DPRK].
Designated pursuant to Section 1(a)(ii)(D) of Executive Order 13551 of August 30, 2010, “Blocking Property of Certain Persons With Respect to North Korea” (E.O. 13551) for having directly or indirectly, engaged in money laundering, the counterfeiting of goods or currency, bulk cash smuggling, narcotics trafficking, or other illicit economic activity that involves or supports the Government of North Korea or any senior official thereof.
1. WEE TIONG (S) PTE LTD (a.k.a. WEE TIONG S PTE LTD), 1813 Geylang Bahru, #01-01 Kallang Distripark 339715, Singapore; 64D Kallang Pudding Road, #02-00, Wee Tiong Building 349323, Singapore; 02-00 Wee Tiong Building, 64D, Kallang Pudding Road 349323, Singapore; 1805 Geylang Bahru #01-03 339711, Singapore; Secondary sanctions risk: North Korea Sanctions Regulations, sections 510.201 and 510.210; Registration Number 199308567K [DPRK].
Designated pursuant to Section 1(a)(ii)(D) E.O. 13551 for having directly or indirectly, engaged in money laundering, the counterfeiting of goods or currency, bulk cash smuggling, narcotics trafficking, or other illicit economic activity that involves or supports the Government of North Korea or any senior official thereof.
2. WT MARINE PTE LTD, #11-09 Parkway Parade 449269, Singapore; 64D Kallang Pudding Road, #09-00 Wee Tiong Building 349323, Singapore; Secondary sanctions risk: North Korea Sanctions Regulations, sections 510.201 and 510.210; Registration Number 201616714Z [DPRK].
Designated pursuant to Section 1(a)(ii)(D) of E.O. 13551 for having directly or indirectly, engaged in money laundering, the counterfeiting of goods or currency, bulk cash smuggling, narcotics trafficking, or other illicit economic activity that involves or supports the Government of North Korea or any senior official thereof.
1. NYMEX STAR Singapore flag; Secondary sanctions risk: North Korea Sanctions Regulations, sections 510.201 and 510.210; Vessel Registration Identification IMO 9078191 (vessel) [DPRK] (Linked To: WT MARINE PTE LTD).
Identified pursuant to E.O. 13551 as property in which WT MARINE PTE LTD, an entity whose property and interests in property are blocked pursuant to E.O. 13551, has an interest.
2. JW JEWEL Singapore flag; Secondary sanctions risk: North Korea Sanctions Regulations, sections 510.201 and 510.210; Vessel Registration Identification IMO 9402964 (vessel) [DPRK] (Linked To: WT MARINE PTE LTD).
Identified pursuant to E.O. 13551 as property in which WT MARINE PTE LTD, an entity whose property and interests in property are blocked pursuant to E.O. 13551, has an interest.
Additionally, on October 25, 2018, OFAC updated the entries on the Specially Designated Nationals and Blocked Persons List for the following individuals, whose property and interests in property are subject to U.S. jurisdiction and who continue to be
1. OWHADI, Mohammad Ebrahim (a.k.a. OWHADI, Jalal; a.k.a. TAHERI, Jalal; a.k.a. VAHEDI, Jalal), Iran; DOB 1963; Gender Male (individual) [SDGT] (Linked To: ISLAMIC REVOLUTIONARY GUARD CORPS (IRGC)-QODS FORCE; Linked To: TALIBAN).
1. OWHADI, Mohammad Ebrahim (a.k.a. OWHADI, Jalal; a.k.a. TAHERI, Jalal; a.k.a. VAHEDI, Jalal), Iran; DOB 1963; Additional Sanctions Information—Subject to Secondary Sanctions; Gender Male (individual) [SDGT] [IRGC] [IFSR] (Linked To: ISLAMIC REVOLUTIONARY GUARD CORPS (IRGC)-QODS FORCE; Linked To: TALIBAN).
Designated on October 23, 2018 pursuant to section 1(c) of E.O. 13224 for acting for or on behalf of the ISLAMIC REVOLUTIONARY GUARD CORPS-QODS FORCE (IRGC-QF), a person determined to be subject to E.O. 13224, and pursuant to section 1(d)(i) of E.O. 13224 for assisting in, sponsoring, or providing financial, material, or technological support for, or financial or other services to or in support of, the TALIBAN, a person determined to be subject to E.O. 13224.
2. RAZAVI, Esma'il (a.k.a. MOHAJERI, Mostafa), Iran; DOB 1959; Gender Male (individual) [SDGT] (Linked To: ISLAMIC REVOLUTIONARY GUARD CORPS (IRGC)-QODS FORCE; Linked To: TALIBAN).
2. RAZAVI, Esma'il (a.k.a. MOHAJERI, Mostafa), Iran; DOB 1959; Additional Sanctions Information—Subject to Secondary Sanctions; Gender Male (individual) [SDGT] [IRGC] [IFSR] (Linked To: ISLAMIC REVOLUTIONARY GUARD CORPS (IRGC)-QODS FORCE; Linked To: TALIBAN).
Designated on October 23, 2018 pursuant to section 1(c) of E.O. 13224 for acting for or on behalf of the IRGC-QF, a person determined to be subject to E.O. 13224, and pursuant to section 1(d)(i) of E.O. 13224 for assisting in, sponsoring, or providing financial, material, or technological support for, or financial or other services to or in support of, the TALIBAN, a person determined to be subject to E.O. 13224.
Departmental Offices, U.S. Department of the Treasury.
Notice.
The Department of the Treasury will submit the following information collection requests to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995, on or after the date of publication of this notice. The public is invited to submit comments on these requests.
Comments should be received on or before November 29, 2018 to be assured of consideration.
Send comments regarding the burden estimate, or any other aspect of the information collection, including suggestions for reducing the burden, to (1) Office of Information and Regulatory Affairs, Office of Management and Budget, Attention: Desk Officer for Treasury, New Executive Office Building, Room 10235, Washington, DC 20503, or email at
Copies of the submissions may be obtained from Jennifer Leonard by emailing
44 U.S.C. 3501
Departmental Offices, U.S. Department of the Treasury.
Notice.
The Department of the Treasury will submit the following information collection requests to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995, on or after the date of publication of this notice. The public is invited to submit comments on these requests.
Comments should be received on or before November 29, 2018 to be assured of consideration.
Send comments regarding the burden estimate, or any other aspect of the information collection, including suggestions for reducing the burden, to (1) Office of Information and Regulatory Affairs, Office of Management and Budget, Attention: Desk Officer for Treasury, New Executive Office Building, Room 10235, Washington, DC 20503, or email at
Copies of the submissions may be obtained from Jennifer Quintana by emailing
44 U.S.C. 3501 et seq.
Departmental Offices, U.S. Department of the Treasury.
Notice.
The Department of the Treasury will submit the following information collection requests to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995, on or after the date of publication of this notice. The public is invited to submit comments on these requests.
Comments should be received on or before November 29, 2018 to be assured of consideration.
Send comments regarding the burden estimate, or any other aspect of the information collection, including suggestions for reducing the burden, to (1) Office of Information and Regulatory Affairs, Office of Management and Budget, Attention: Desk Officer for Treasury, New Executive Office Building, Room 10235, Washington, DC 20503, or email at
Copies of the submissions may be obtained from Jennifer Quintana by emailing
44 U.S.C. 3501 et seq.
Departmental Offices, U.S. Department of the Treasury.
Notice.
The Department of the Treasury will submit the following information collection requests to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995, on or after the date of publication of this notice. The public is invited to submit comments on these requests.
Comments should be received on or before November 29, 2018 to be assured of consideration.
Send comments regarding the burden estimate, or any other aspect of the information collection, including suggestions for reducing the burden, to (1) Office of Information and Regulatory Affairs, Office of Management and Budget, Attention: Desk Officer for Treasury, New Executive Office Building, Room 10235, Washington, DC 20503, or email at
Copies of the submissions may be obtained from Jennifer Quintana by emailing
44 U.S.C. 3501 et seq.
Department of Veterans Affairs.
Notice; correction.
The Department of Veterans Affairs (VA) is correcting a Notice that published in the
Annual pay ranges are applicable November 25, 2018.
Farine Cohen, Program Analyst, Policy and Programs, VHA Workforce Management and Consulting Office (10A2A), Department of Veterans Affairs, 810 Vermont Avenue NW, Washington, DC 20420, (202) 461-7179. This is not a toll-free number.
On September 12, 2018, at 83 FR 46258, VA published a Notice that provides information and gives notices of annual pay ranges for VHA podiatrists as prescribed by the Secretary for Department-wide applicability. The pay table placement and annual salary rates of podiatrists is intended to enhance the flexibility of the Department to recruit, develop, and retain the most highly-qualified podiatrists to serve our Nation's Veterans and maintain a standard of excellence in the VA health care system.
In FR Doc. 20018-19847, appearing on page 46259 in the
1. On page 46259, in the Pay Table 1—Clinical Specialty, the minimum TIER 1 dollar amount should be corrected to read as $103,395 vs. $100,967.
(a) Executive departments and agencies (agencies) shall report to the Secretary of Commerce (Secretary), working through the National Telecommunications 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.
(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;
(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.
(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.
(f) The Secretary is authorized and directed to publish this memorandum in the
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration |