May 26, 2023 – Federal Register Recent Federal Regulation Documents

We, the U.S. Fish and Wildlife Service, announce receipt of an application for an incidental take permit under the Endangered Species Act and a draft habitat conservation plan from the Sweetwater Authority. We request public comment on the application, which includes the applicant's proposed habitat conservation plan (HCP), and on the Service's preliminary determination that the proposed permitting action may be eligible for a categorical exclusion pursuant to the Council on Environmental Quality's National Environmental Policy Act (NEPA) regulations, the Department of the Interior's (DOI) NEPA regulations, and the DOI Departmental Manual. To make this preliminary determination, we prepared a draft environmental action statement and low-effect screening form, which is also available for public review. We invite comment from the public and local, State, Tribal, and Federal agencies.

In accordance with the National Environmental Policy Act of 1969, as amended (NEPA), and the Federal Land Policy and Management Act of 1976, as amended (FLPMA), the Bureau of Land Management (BLM) has prepared a draft environmental impact statement (Draft EIS)/resource management plan amendments (RMPA) for the Greenlink West Project and by this notice is providing information announcing the opening of the comment period on the Draft EIS/RMPA. The BLM Nevada State Office is the lead agency for purposes of the NEPA analysis with the U.S. National Park Service (NPS), Bureau of Indian Affairs (BIA), and other agencies serving as cooperating agencies.

This proposed rule would seek to implement policies in the Medicaid Drug Rebate Program (MDRP) related to the new legislative requirements in the Medicaid Services Investment and Accountability Act of 2019 (MSIAA), which are needed to address drug misclassification, as well as drug pricing and product data misreporting by manufacturers. Additionally, we are proposing several other program integrity and program administration provisions or modifications in this proposed rule including revising and proposing key definitions used in the MDRP. This proposed rule also designates a time limitation on manufacturers initiating audits with States; clarifies and establishes requirements for State fee-for-service (FFS) pharmacy reimbursement; codifies conditions relating to States claiming FFP for physician-administered drugs (PADs); clarifies the requirement of accumulating price concessions when determining best price; designates drug price verification and transparency through data collection; and proposes two new contracting requirements between States and their Medicaid managed care plans. In addition, this rule includes a proposal unrelated to MDRP that would make revisions to the third-party liability regulation due to Bipartisan Budget Act (BBA) of 2018. Finally, we are proposing to rescind revisions made by the December 31, 2020 final rule ``Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements'' to the Determination of Best Price and Determination of Average Manufacturer Price (AMP) sections.

The United States Environmental Protection Agency (EPA) is proposing amendments to the new chemicals procedural regulations under the Toxic Substances Control Act (TSCA). These amendments are intended to align the regulatory text with the amendments to TSCA's new chemicals review provisions contained in the Frank R. Lautenberg Chemical Safety for the 21st Century Act, enacted on June 22, 2016, improve the efficiency of EPA's review processes, and update the regulations based on existing policies and experience implementing the New Chemicals Program. The proposal includes amendments that would reduce the need to redo all or part of the risk assessment by improving information initially submitted in new chemicals notices, which should also help reduce the length of time that new chemicals notices are under review. EPA is also proposing several amendments to the regulations for low volume exemptions (LVEs) and low release and exposure exemptions (LoREXs), which include requiring EPA approval of an exemption notice prior to commencement of manufacture, making per- and polyfluoroalkyl substances (PFAS) categorically ineligible for these exemptions, and providing that certain persistent, bioaccumulative, toxic (PBT) chemical substances are ineligible for these exemptions, consistent with EPA's 1999 PBT policy.

The Energy Policy and Conservation Act, as amended (``EPCA''), prescribes energy conservation standards for various consumer products and certain commercial and industrial equipment, including room air conditioners. EPCA also requires the U.S. Department of Energy (``DOE'') to periodically determine whether more-stringent, standards would be technologically feasible and economically justified, and would result in significant energy savings. In this final rule, DOE is adopting amended energy conservation standards for room air conditioners. It has determined that the amended energy conservation standards for these products would result in significant conservation of energy, and are technologically feasible and economically justified.

The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to issue coastwise endorsement eligibility determinations for foreign-built vessels which will carry no more than twelve passengers for hire. A request for such a determination has been received by MARAD. By this notice, MARAD seeks comments from interested parties as to any effect this action may have on U.S. vessel builders or businesses in the U.S. that use U.S.-flag vessels. Information about the requestor's vessel, including a brief description of the proposed service, is listed below.

The Federal Emergency Management Agency (FEMA) is issuing this notice and request for information (RFI) to seek input from the public on implementation of the Community Disaster Resilience Zones Act of 2022, including updates to the methodology and data used for the National Risk Index and any other hazard assessment products; potential improvements to FEMA's provision of hazard data; the process used to designate community disaster resilience zones; financial and technical assistance for resilience or mitigation projects primarily benefitting community disaster resilience zones; and the community disaster resilience zone project application and certification process.

The Environmental Protection Agency (EPA) published a notice in the Federal Register on April 21, 2023, requesting comments on a proposed Information Collection Request (EPA ICR Number 2723.01, OMB Control Number 2040-NEW) being submitted to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. That notice contained an error in the Agency Docket ID Number. This document corrects that error.

The Commission is noticing a recent Postal Service filing for the Commission's consideration concerning a negotiated service agreement. This notice informs the public of the filing, invites public comment, and takes other administrative steps.

In accordance with the procedures governing the application for, and the processing of, special permits from the Department of Transportation's Hazardous Material Regulations, notice is hereby given that the Office of Hazardous Materials Safety has received the application described herein.

In accordance with the procedures governing the application for, and the processing of, special permits from the Department of Transportation's Hazardous Material Regulations, notice is hereby given that the Office of Hazardous Materials Safety has received the application described herein.

The Children's Bureau (CB), the Administration for Children and Families (ACF) is requesting a three-year extension of the data information collection for the Adoption and Foster Care Analysis and Reporting System (AFCARS) that was implemented as part of the AFCARS final rule published in May 2020 (85 FR 28410). There are no proposed changes to the data information collection published as the regulation in May 2020. The estimated time per response related to record keeping has been revised since the previous published notice (88 FR 16449) due to feedback from the State and Tribal reporting agencies.

The Maritime Administration (MARAD) requests applications from qualified candidates to enter into Maritime Security Program (MSP) Operating Agreements for the operation of two U.S.-registered merchant vessels in international trade, subject to the availability of appropriations. The MSP maintains a fleet of active, commercially viable, militarily useful, privately-owned U.S.-flagged vessels that are engaged in international trade and are capable of supporting both U.S. economic competitiveness in peacetime and national defense and security requirements in times of conflict or emergency. This request for applications provides, among other things, application criteria and a deadline for submitting applications for vessel enrollment into MSP.

The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to issue coastwise endorsement eligibility determinations for foreign-built vessels which will carry no more than twelve passengers for hire. A request for such a determination has been received by MARAD. By this notice, MARAD seeks comments from interested parties as to any effect this action may have on U.S. vessel builders or businesses in the U.S. that use U.S.-flag vessels. Information about the requestor's vessel, including a brief description of the proposed service, is listed below.

The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to issue coastwise endorsement eligibility determinations for foreign-built vessels which will carry no more than twelve passengers for hire. A request for such a determination has been received by MARAD. By this notice, MARAD seeks comments from interested parties as to any effect this action may have on U.S. vessel builders or businesses in the U.S. that use U.S.-flag vessels. Information about the requestor's vessel, including a brief description of the proposed service, is listed below.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures.'' This guidance document provides recommendations that may help manufacturers comply with the special controls related to non-clinical performance data for gynecologic and general laparoscopic power morcellation containment systems (``tissue containment systems''). Tissue containment systems are used to enable isolation and containment of tissue during a power morcellation procedure performed following a laparoscopic procedure for the excision of benign tissue that is not suspected to contain malignancy.

On May 18, 2023, the Department of Education (Department) published in the Federal Register a notice of proposed rulemaking (NPRM) to amend regulations under Part B of the Individuals with Disabilities Education Act (Part B of IDEA or the Act) that govern the Assistance to States for the Education of Children with Disabilities program, including the Preschool Grants program. We are correcting the Docket ID used for submitting public comments. All other information in the NPRM remains the same.