2023 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``COVID-19: Developing Drugs and Biological Products for Treatment or Prevention.'' The purpose of this guidance is to assist sponsors in the clinical development of drugs and biological products for the treatment or prevention of COVID-19. This guidance describes FDA's current recommendations for phase 2 and phase 3 trials with a focus on trial population, trial design, efficacy endpoints, safety considerations, and statistical considerations. This guidance supersedes the guidance of the same name initially issued on May 19, 2020, and reissued on February 22, 2021.

We, the Fish and Wildlife Service (Service), announce receipt of an application from Vistas at Davenport, LLC (applicant) for an incidental take permit (ITP) under the Endangered Species Act. The applicant requests the ITP to take the federally listed sand skink and blue-tailed mole skink incidental to the construction of a residential development in Polk County, Florida. 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, both of which are also available for public review. We invite comment from the public and local, State, Tribal, and Federal agencies.

Isosciences, LLC has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information.

This action adds service(s) to the Procurement List that will be furnished by nonprofit agencies employing persons who are blind or have other severe disabilities.

We, the Fish and Wildlife Service (Service), announce receipt of an application from the Orange County Public Library System (Horizon West Library; applicant) for an incidental take permit (ITP) under the Endangered Species Act. The applicant requests the ITP to take the federally listed sand skink (Neoseps reynoldsi) incidental to the construction and operation of a public library and related activities in Orange County, Florida. 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, both of which are also available for public review. We invite comment from the public and local, State, Tribal, and Federal agencies.

In the Federal Register of October 18, 2023, EPA issued a notice to announce the availability of EPA's interim registration review decisions for the following chemicals: Citric acid and salts, and linalool; and the closure of the registration review case for triadimenol. That notice incorrectly included a DATES section that established a comment deadline of December 18, 2023. A comment period is not necessary or appropriate for that document because the decisions announced in that document are final for triadimenol, and final for the interim phase of the process for citric acid and salts, and linalool. This document corrects that document by reaffirming the nature of all the decisions announced in that document and by closing the comment period it incorrectly established.

The Commission previously proposed amendments to its regulations concerning rate incentives for Market Dominant products. After the period for filing comments in the instant docket closed, in Docket No. R2023-3, the Postal Service proposed, and the Commission subsequently approved, two Market Dominant rate incentives for Calendar Year (CY) 2024. Because the rule proposals in the instant docket may have a bearing on any future proposals to include these rate incentives in the percentage change in rates calculation, the Commission provides the public with an opportunity to comment on the relationship of the rule proposals in the instant docket and the rate incentives approved for CY 2024 in Docket No. R2023-3.

Navinta LLC has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information.

VHG Labs DBA LGC Standards has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information.

National Marine Fisheries Service (NMFS) is providing notification that the agency will not identify additional fisheries to observe on the 2024 Annual Determination (AD), pursuant to its authority under the Endangered Species Act (ESA). Through the AD, NMFS identifies U.S. fisheries operating in the Atlantic Ocean, Gulf of Mexico, and Pacific Ocean that will be required to take observers upon NMFS' request. The purpose of observing identified fisheries is to learn more about sea turtle bycatch in a given fishery, evaluate measures to prevent or reduce sea turtle bycatch, and implement the prohibition against sea turtle takes. Fisheries identified on the 2020 and 2023 ADs (see table 1) remain on the AD for a 5-year period and are required to carry observers upon NMFS' request until September 29, 2025, for the 2020 AD and December 31, 2027, for the 2023 AD.

The Coast Guard is establishing a temporary safety zone for all navigable waters within a 1,000-foot radius of a fireworks launch barge in Lake Charles, LA. This safety zone is necessary to protect persons and vessels from hazards associated with a fireworks display. This regulation prohibits persons and vessels from entering the safety zone unless authorized by the Captain of the Port, Marine Safety Unit Port Arthur, or a designated representative.

The FAA announces its decision to adopt the USAF FEIS Airspace Optimization for Readiness at Mountain Home Air Force Base (MHAFB), Mountain Home, Idaho. Based on its independent review and evaluation of the FEIS and supporting documents, the FAA is adopting the FEIS and issuing a ROD for the modification of special use airspace (SUA) at the Mountain Home Range Complex (MHRC).

The Rural Business-Cooperative Service (RB-CS) (Agency), a Rural Development (RD) agency of the United States Department of Agriculture (USDA), is issuing a final rule to amend the interim rule published on May 22, 2020. The interim rule amended the Business and Industry (B&I) Guaranteed Loan Program to allow flexibility to obligate Federal funds for guaranteed loans pursuant to the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) in response to the national COVID-19 Public Health Emergency. This final rule addresses public comments received on the interim rule and makes clarifying modifications identified by commenters and the Agency.

This notice acknowledges the receipt of an application from the Accreditation Commission for Health Care (ACHC) for continued approval by the Centers for Medicare & Medicaid Services (CMS) of ACHC's national accrediting organization program for suppliers providing home infusion therapy (HIT) services and that wish to participate in the Medicare or Medicaid programs. The statute requires that within 60 days of receipt of an organization's complete application, CMS will publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.

This notice acknowledges the receipt of an application from a hospital that has requested a waiver of statutory requirements that would otherwise require the hospital to enter into an agreement with its designated organ procurement organization (OPO). This notice requests comments from OPOs and the general public for our consideration in determining whether we should grant the requested waiver.

The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.

The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.

Notice is hereby given that Adam Pack, Ph.D., University of Hawaii at Hilo, 200 West Kawili Street, Hilo, HI 96720, has applied for an amendment to Scientific Research Permit No. 26593.

The Federal Bureau of Investigation, Department of Justice (DOJ), will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995.

The Commission is recognizing a recently filed Postal Service document with the Commission concerning its plan to remedy inefficiencies identified in the Commission's flats study. This notice informs the public of the filing, invites public comment, and takes other administrative steps.

The Department of Labor (DOL) is correcting a notice that appeared in the Federal Register on October 17, 2023. DOL is correcting an error in the estimated burden hours, estimated number of respondents and the estimated number of responses. This is an Employee Benefits Security Administration (EBSA)-sponsored information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (PRA). Public comments on the ICR are invited.