Department of Health and Human Services December 2, 2024 – Federal Register Recent Federal Regulation Documents

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during July, August, and September 2024. The animal drug regulations are also being amended to improve their accuracy and readability.

The Administration for Children and Families (ACF) Office of Community Services (OCS) within the U.S. Department of Health and Human Services (HHS) is requesting an extension without change to the current version of the Low Income Home Energy Assistance Program (LIHEAP) Performance Measures (Office of Management and Budget (OMB) #0970-0449) for use through June 30,2025, and for approval of a revised version to use beginning July 1, 2025.

In accordance with the Federal Advisory Committee Act, HHS is hereby giving notice that the National Advisory Council on Nurse Education and Practice (NACNEP or Council) is rechartered.

This notice announces a $730.00 calendar year (CY) 2025 application fee for institutional providers that are initially enrolling in the Medicare or Medicaid program or the Children's Health Insurance Program (CHIP); revalidating their Medicare, Medicaid, or CHIP enrollment; or adding a new Medicare practice location. This fee is required with any enrollment application submitted on or after January 1, 2025, and on or before December 31, 2025.

As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services (HHS) is hereby giving notice that the Advisory Committee on Minority Health (ACMH) will hold a meeting conducted as a webcast on December 16, 2024. This virtual meeting will be open to the public. Registration is required for the public to attend the meeting, provide comment, and/or distribute material(s) to ACMH members.

The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that KEBILIDI (eladocagene exuparvovec-tneq), approved on November 13, 2024, manufactured by PTC Therapeutics Inc., meets the criteria for a priority review voucher.

In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), is seeking nominations for membership on the Safety and Occupational Health Study Section (SOHSS). SOHSS consists of 20 experts in fields associated with occupational medicine and nursing, industrial hygiene, occupational safety and engineering, toxicology, chemistry, safety and health education, ergonomics, epidemiology, economic science, psychology, pulmonary pathology/physiology, and social science.