2024 – 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 "Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development; Guidance for Industry." This guidance is intended to provide a framework for considering whether and what type of long-term neurologic, sensory, and developmental evaluations could be useful in supporting a determination of safety of an FDA-regulated "medical product" (i.e., drug, biological product, or medical device) for use in neonates. Although short-term safety evaluations may be appropriate for adults or other populations, such evaluations may not identify important adverse events in the neonatal population, as medical treatment during the neonatal period coincides with a time of critical growth and physiologic development and latent effects may not be evident until later in life following early-life exposures. Consideration of the potential for long-term neurologic, sensory, and developmental effects in the neonatal population early in a development program is important for establishing safety of a medical product intended for use in neonates. This guidance finalizes the draft guidance of the same title issued on February 13, 2023.

The Food and Drug Administration (FDA or Agency) is withdrawing approval of the new drug application (NDA) 205851 and the new animal drug application (NADA) 141-389 for the designated medical gas Helium, USP held by Linde, Inc., 175 East Park Dr., Tonawanda, NY 14150-7844. Linde, Inc. notified the Agency in writing that the drug product was no longer marketed and requested that the approval of the application be withdrawn.

The Food and Drug Administration (FDA, Agency, or we) has determined that TAVIST (clemastine fumarate) tablet, 2.68 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.

The Coast Guard is establishing a temporary safety zone for certain navigable waters within St. John's River in Jacksonville, FL. This action is necessary to provide for the safety of life on these navigable waters during the Naval Air Station Jacksonville Air Show. Entry of vessels or persons into this safety zone is prohibited unless specifically authorize by the Captain of the Port Sector Jacksonville or a designated representative.

On July 26, 2024, President Joseph Biden issued a memorandum to the Secretary of State and the Secretary of Homeland Security (Secretary) determining that it was in the foreign policy interest of the United States to defer for 18 months through January 25, 2026, the removal of certain Lebanese nationals present in the United States and to provide them with employment authorization documentation. The memorandum directed the Secretary to make provision for immediate allowance of employment authorization for such individuals. This notice provides information about Deferred Enforced Departure (DED) for Lebanese nationals and provides information on how eligible individuals may apply for DED-based Employment Authorization Documents (EADs) with USCIS, as well as for travel authorization.

The Environmental Protection Agency (EPA) Administrator signed an order dated July 31, 2024, granting in part and denying in part a petition dated April 1, 2024, from the Center for Biological Diversity. The petition requested that the EPA object to a Clean Air Act (CAA) operating permit issued by the Colorado Department of Public Health and Environment's Air Pollution Control Division (Division) to HighPoint Operating Corporation for its Anschutz Equus Farms 4-62-28 NWNW oil and gas production facility located in Weld County, Colorado.

This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the State of Georgia (FEMA-4830-DR), dated 10/09/2024. Incident: Hurricane Helene. Incident Period: 09/24/2024 and continuing.

This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the State of Florida (FEMA-4828-DR), dated 10/05/2024. Incident: Hurricane Helene. Incident Period: 09/23/2024 and continuing.

The Coast Guard is establishing a temporary safety zone for all navigable waters from mile marker 607 to 612 of the Ohio River in New Albany, IN. The safety zone is needed to protect personnel, vessels, and the marine environment from potential hazards created by the demolition at Duke Energy Gallagher Station. Entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port, Sector Ohio Valley.

In accordance with the Paperwork Reduction Act of 1995, this notice invites the general public and other public agencies to comment on this proposed information collection. This new collection will provide the U.S. Department of Agriculture, Food and Nutrition Service (FNS) key information from a large representative sample of SNAP households to enable FNS to examine how SNAP households change through time.

On August 12, 2024, interstate passenger motor carriers Avalon Transportation, LLC (Avalon Transportation), and Avalon Motor Coaches, LLC (Avalon Motor Coaches), filed an application for control over certain assets of the following Coach USA, Inc. (Coach USA) subsidiaries: Kerrville Bus Company, Inc. (Kerrville); All West Coachlines, Inc. (All West); American Coach Lines of Atlanta, Inc. (ACL Atlanta); Coach Leasing, Inc.; CAM Leasing, LLC; and Coach USA Administration, Inc. (collectively, Coach USA Subsidiaries). On September 19, 2024, Virgin-Fish, Inc. (Virgin-Fish), and Jeffrey Brush submitted a filing joining the application. (Avalon Transportation, Avalon Motor Coaches, Virgin-Fish, and Jeffrey Brush will be collectively referred to as "Avalon" or "Applicants.") The Board is tentatively approving and authorizing this transaction. If no opposing comments are timely filed, this notice will be the final Board action.

The North Pacific Fishery Management Council (Council) Bering Sea Aleutian Islands Crab Plan Team (BSAI CPT) will meet November 5, 2024.

The Ecosystem-Based Management Subcommittee (SSC ES) of the Pacific Fishery Management Council's (Pacific Council) Scientific and Statistical Committee (SSC) will convene an online meeting to review new forage indicators in the California Current Integrated Ecosystem Assessment Team's Ecosystem Status Report. This review may potentially inform future annual reports to the Pacific Council on the state of the California Current Ecosystem. The SSC ES meeting is open to the public.

This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the State of South Carolina (FEMA-4835-DR), dated 09/29/2024. Incident: Tropical Storm Debby. Incident Period: 08/04/2024 through 08/22/2024.

This notice announces an in-person/virtual hybrid 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 Federal Register.

HRSA published a notice in the Federal Register of July 23, 2024, concerning a meeting of the National Advisory Council on Migrant Health on October 22, 2024, and October 23, 2024. The notice states the meeting will be held in-person and via webinar. However, due to the impact of recent hurricanes on council members, this meeting now will be held via webinar only on Zoom.

The U.S. Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing the names of one or more persons that have been placed on OFAC's Specially Designated Nationals and Blocked Persons List (SDN 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 are blocked, and U.S. persons are generally prohibited from engaging in transactions with them.