Department of Health and Human Services September 30, 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 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.

The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a document entitled "Amended Environmental Assessment for Production of AquAdvantage Salmon at the Bay Fortune and Rollo Bay Facilities on Prince Edward Island, Canada." This amended environmental assessment (EA) has been prepared by FDA in support of the approved new animal drug application (NADA 141-454) concerning AquAdvantage Salmon (AAS), in response to an order by the U.S. District Court, Northern District of California.

The Food and Drug Administration (FDA or the Agency) is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. Nominees recommended to serve as a voting or nonvoting consumer representative may be self-nominated or may be nominated by a consumer organization. FDA seeks to include the views of individuals on its advisory committee regardless of their gender identification, religious affiliation, racial and ethnic identification, or disability status and, therefore, encourages nominations of appropriately qualified candidates from all groups.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Clarification of Radiation Control Regulations for Manufacturers of Diagnostic X-Ray Equipment." This guidance provides clarification to industry and FDA staff of the Federal regulations that relate to diagnostic x-ray equipment. These regulations pertain to the recordkeeping, reporting, manufacturing, importing, and installation of an "electronic product" as defined in FDA regulations. This guidance supersedes FDA's 1989 guidance entitled "Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment."

The Food and Drug Administration's (FDA), Center for Veterinary Medicine's (CVM), Office of Management (OM) and Office of New Animal Drug Evaluation (ONADE) have modified their organizational structures. The new organizational structures were approved by the Secretary of Health and Human Services on July 22, 2024.

The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), announces the renewal of the charter of the Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP).

In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.