Department of Health and Human Services September 19, 2024 – Federal Register Recent Federal Regulation Documents

This notice announces the dates and times of the virtual Healthcare Common Procedure Coding System (HCPCS) public meeting to be held from November 6, 2024, through November 8, 2024, to discuss CMS' preliminary coding, Medicare benefit category, and payment determinations, if applicable, for new revisions to the HCPCS Level II code set for non-drug and non-biological items and services, as well as how to register for those meetings.

This final notice announces our decision to approve the National Association of Boards of Pharmacy (NABP) for continued recognition as a national accrediting organization that accredits suppliers of home infusion therapy (HIT) services that wish to participate in the Medicare or Medicaid programs.

HRSA is awarding supplemental funds in fiscal year 2024 to provide coverage for calls to the toll-free Poison Help line that originate from Puerto Rico. The current program period of performance ends on August 31, 2024.

CDC has modified its structure. This notice announces the reorganization of the Office of Laboratory Science and Safety (OLSS). OLSS was retitled to the Office of Laboratory Systems and Response (OLSR) and additional organizational updates were approved.

The ACF, OCS, Division of Energy Assistance announces a preliminary determination that funds from the federal fiscal year 2023 (FY23) Low Income Home Energy Assistance Program (LIHEAP) are available for reallotment to states, territories, tribes, and tribal organizations that received FY24 direct LIHEAP awards. The purpose of this award is to redistribute FY23 annual LIHEAP funds that recipients were unable to obligate or carry over to FY24. No sub-recipients of these recipients or other entities may apply for these funds.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA or the Agency) is announcing the fee rate for using a priority review voucher for fiscal year (FY) 2025. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended, authorizes FDA to determine and collect priority review user fees for certain applications for review of human drug or biological products when those applications use a tropical disease, rare pediatric disease, or material threat medical countermeasure (MCM) priority review voucher. These vouchers are awarded to the sponsors of tropical disease, rare pediatric disease, or material threat MCM product applications, respectively, that meet the requirements of the FD&C Act, upon FDA approval of such applications. The amount of the fee for using a priority review voucher is determined each fiscal year, based on the difference between the average cost incurred by FDA to review a human drug application designated as priority review in the previous fiscal year, and the average cost incurred in the review of an application that is not subject to priority review in the previous fiscal year. This notice establishes the FY 2025 priority review fee rate applicable to submission of eligible applications for review of human drug or biological products using a rare pediatric disease, material threat MCM, or tropical disease priority review voucher and outlines the payment procedures for such fees.

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 a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate 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.