June 24, 2021 – Federal Register Recent Federal Regulation Documents

The Environmental Protection Agency (EPA), Office of Research and Development (ORD), gives notice of a virtual meeting of the Board of Scientific Counselors (BOSC) Executive Committee (EC) to conduct a consultation on equity and barriers to environmental justice.

This document corrects technical and typographical errors in the proposed rule that appeared in the May 10, 2021 Federal Register titled ``Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long Term Care Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2022 Rates; Quality Programs and Medicare Promoting Interoperability Program Requirements for Eligible Hospitals and Critical Access Hospitals; Proposed Changes to Medicaid Provider Enrollment; and Proposed Changes to the Medicare Shared Savings Program.''

The Coast Guard is establishing a special local regulation on the waters of the Gulf of Mexico, in the vicinity of Lido Beach, Florida, during the Sarasota Powerboat Grand Prix. Approximately 70 boats and jet skis, traveling at speeds in excess of 100 miles per hour are expected to participate. Additionally, it is anticipated that 100 spectator vessels will be present along the race course. The special local regulation is necessary to protect the safety of race participants, participant vessels, spectators, and the general public on certain navigable waters of the Gulf of Mexico, Lido Beach, Florida during the event. The special local regulation will establish an enforcement area where all persons and vessels, except those persons and vessels participating in the high speed boat races, are prohibited from entering, transiting through, anchoring in, or remaining within the regulated area without obtaining permission from the Captain of the Port St. Petersburg or a designated representative.

The Coast Guard is establishing a series of temporary safety zones on the waters of Boothbay Harbor, Maine. These safety zones are necessary to provide for the safety of participant vessels and the general public during Tall Ships Boothbay Harbor, 2021, an event allowing for public tours of tall ships (large sailing vessels) from various countries while at the docks of Boothbay Harbor, Maine. When enforced, this rule will prohibit persons and vessels from entering into the safety zone unless authorized by the Captain of the Port Northern New England or a designated representative.

On December 19, 2019, Holtec Decommissioning International, LLC (HDI) submitted to the U.S. Nuclear Regulatory Commission (NRC) a letter enclosing the post-shutdown decommissioning activities report (PSDAR) for the Indian Point Nuclear Generating, Unit Nos. 1, 2, and 3 (Indian Point Energy Center (IPEC)), contingent upon the transfer of the IPEC licenses to HDI. The PSDAR, which includes the site-specific decommissioning cost estimate (DCE), provides an overview of HDI's planned activities, schedule, projected costs, and environmental impacts for the decommissioning of the IPEC. The IPEC license transfer transaction closed on May 28, 2021. Accordingly, the NRC is noticing receipt of the PSDAR and making it available for public comment. The NRC will hold a public meeting in the vicinity of the IPEC to discuss the PSDAR's content and receive comments. The date, time, and location of the meeting will be provided in a future Federal Register notice.

The U.S. Nuclear Regulatory Commission (NRC) is issuing for public comment a draft regulatory guide (DG), DG-4029, ``Use of Plant Parameter Envelope in Early Site Permit Applications.'' DG-4029 is a new regulatory guide that proposes guidance for nuclear power plant applicants that elect to use the plant parameter envelope (PPE) concept to assume certain design parameters for an early site permit (ESP) application when a specific reactor technology has not been selected for a proposed site. It incorporates the PPE portions of NRC Review Standard (RS)-002, ``Processing Applications for Early Site Permits.'' The issuance of this DG allows the NRC staff to withdraw the outdated guidance in RS-002 while retaining the PPE information in it for future use by prospective ESP applicants.

The Commission hereby gives notice of the scheduling of the final phase of antidumping investigation Nos. 731-TA-1550-1553 (Final) pursuant to the Tariff Act of 1930 (``the Act'') to determine whether an industry in the United States is materially injured or threatened with material injury, or the establishment of an industry in the United States is materially retarded, by reason of imports of polyester textured yarn from Indonesia, Malaysia, Thailand, and Vietnam, provided for in subheadings 5402.33.30 and 5402.33.60 of the Harmonized Tariff Schedule of the United States, preliminarily determined by the Department of Commerce (``Commerce'') to be sold at less-than-fair- value.

On December 14, 2020, the Department of Health and Human Services published in the Federal Register a final rule (``Rule'') establishing the 340B Drug Pricing Program (340B Program) Administrative Dispute Resolution (ADR) Board (hereafter, ``the Board''). See 85 FR 80632 (Dec. 14, 2020). According to the Rule, the purpose of the 340B Program's ADR process is to resolve (1) claims by covered entities that they have been overcharged for covered outpatient drugs by manufacturers and (2) claims by manufacturers, after a manufacturer has conducted an audit as authorized by section 340B(a)(5)(C) of the Public Health Service Act, that a covered entity has violated the prohibitions on diversion or duplicate discounts. The Rule states that Board members from the Centers for Medicare & Medicaid Services (CMS) and the Health Resources and Services Administration (HRSA) must have relevant expertise and experience in drug pricing or drug distribution. The Rule also states that Board members from the Office of the General Counsel (OGC) must have expertise and experience in handling complex litigation. From the 340B ADR Board, the HRSA Administrator will select three voting members, one from each of the three HHS operating/staff divisions involved (i.e., CMS, HRSA, OGC) to form 340B ADR Panels that will review claims and, pursuant to delegated authority from the Secretary, make certain final agency decisions. All previous appointments to the Board are revoked. Based on recommendations from OGC, CMS, and HRSA, I hereby appoint the following Board members, who shall serve a term of two years, to be extended for additional terms upon agreement by the member and the head of his or her operating/staff division. Sean R. Keveney, Deputy General Counsel, the Office of the General Counsel, Department of Health and Human Services; Andy J. Miller, National Complex Litigation and Investigations Division Attorney, the Office of the General Counsel, Department of Health and Human Services; Glenn Clark, Public Health Advisor, HIV/AIDS Bureau, Health Resources and Services Administration, Department of Health and Human Services; CAPT Christina Meade, Area Regional Pharmacy Consultant, Office of Regional Operations, Health Resources and Services Administration, Department of Health and Human Services; CDR Timothy Lape, Division of Medicare Health Plans Operations, Medicare Branch, Centers for Medicare & Medicaid Services, Department of Health and Human Services; Adele Pietrantoni, Office of Program Operations and Local Engagement, Division of Drug and Health Plan Operations, Centers for Medicare & Medicaid Services, Department of Health and Human Services; Chantelle Britton, Senior Advisor, Office of Pharmacy Affairs, Health Resources and Services Administration, Department of Health and Human Services, as ex-officio, non-voting member; and Julie Zadecky, Pharmacist, Office of Pharmacy Affairs, Health Resources and Services Administration, Department of Health and Human Services, as ex-officio, non-voting member.

In accordance with the requirements of the Paperwork Reduction Act of 1995, the Department of Transportation (the Department) invites public comments on a request to the Office of Management and Budget (OMB) to approve modifications to a currently approved Information Collection Request (ICR). The forms have been updated to reflect efficiencies in the application process adopted by the Department, provide clarifying information, and make the forms easier for applicants to use. The general process of applying for credit assistance is not changing; applications are still accepted on a rolling basis. The ICR continues to be necessary for the Department to evaluate projects and project sponsors for credit program eligibility and creditworthiness as required by law.

FRA is issuing this notice of conditional approval to Alaska Railroad Corporation (ARRC) in response to its August 29, 2020, petition to extend FRA's approval authorizing ARRC's transport of Liquefied Natural Gas (LNG) by rail in cryogenic portable tanks (T75, UN cryogenic portable tanks or cryogenic ISO tanks).

The FHWA, on behalf of Caltrans, is issuing this notice to announce actions taken by Caltrans that are final within the meaning of 23 U.S.C. 139(l)(1). The actions relate to the proposed Eastbound (EB) State Route 91 (SR-91) Atlantic Ave. to Cherry Ave. Auxiliary Lane Improvements Project on SR-91 at post mile R11.8 to R13.2 within the County of Los Angeles, State of California. Those actions grant licenses, permits, and approvals for the project.

The Copyright Royalty Judges solicit comments on a motion of Allocation Phase claimants for partial distribution of 2019 cable royalty funds.

In accordance with Section 3(b) of the Wild and Scenic Rivers Act, the USDA, Forest Service, Washington Office, is transmitting the final boundary to Congress for the Snake River Headwaters National Wild and Scenic River segments administered by the Secretary of Agriculture (acting through the Chief of the Forest Service).

Notice is hereby given that Sea World LLC (Responsible Party: Christopher Dold, DVM), 6240 Sea Harbor Drive, Orlando, Florida 32821, has applied in due form for a permit to continue captive maintenance and enhancement activities on two non-releasable Guadalupe fur seals (Arctocephalus townsendi) with the option of holding up to six non- releasable furs seals at any given time.

The Copyright Royalty Judges solicit comments on a motion of Allocation Phase claimants for partial distribution of 2019 satellite royalty funds.