Department of Health and Human Services December 13, 2023 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a summary on the comments received for the ``Methodological Challenges Related to Patient Experience Data; Request for Information and Comments'' notice published on May 2, 2023. The input received in response to the Request for Information will help FDA plan two public workshops focused on methodological challenges and will help FDA identify priorities for future work.

The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a draft guidance for industry entitled ``Advanced Manufacturing Technologies Designation Program.'' FDA encourages the early adoption of advanced manufacturing technologies (AMTs) that have the potential to benefit patients by improving manufacturing and supply dependability and optimizing development time of drug and biological products. These technologies can be integral to ensuring quality and supporting a robust supply of drugs that are life-supporting, life-sustaining, of critical importance to providing healthcare, or in shortage. AMTs can directly improve product quality through higher capability manufacturing designs and enhanced controls (e.g., leading to fewer human errors). This draft guidance provides recommendations to persons and organizations interested in participating in FDA's Advanced Manufacturing Technologies Designation Program, which is intended to facilitate the development of drugs, including biological products, manufactured using an AMT that has been designated as such under the program.

Under the Federal Advisory Committee Act, the Food and Drug Administration (FDA) is announcing the establishment of the Genetic Metabolic Diseases Advisory Committee. The Commissioner of Food and Drugs (Commissioner) has determined that it is in the public interest to establish such a committee. Duration of this committee is 2 years from the date the Charter is filed, unless the Commissioner formally determines that renewal is in the public interest.

The Food and Drug Administration (FDA or Agency) is requesting nominations for a voting consumer representative to serve on the Genetic Metabolic Diseases Advisory Committee. FDA is also requesting that any consumer organizations interested in participating in the selection of a voting consumer representative to serve on the Genetic Metabolic Diseases Advisory Committee notify FDA in writing. Nominees recommended to serve as a voting consumer representative may either be self-nominated or may be nominated by a consumer organization. Nominations will be accepted for the current vacancy effective with this notice. FDA seeks to include the views of members of all gender groups, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups.

In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

The Departments of Health and Human Services and Agriculture announce the fourth meeting of the 2025 Dietary Guidelines Advisory Committee (Committee). This meeting will be open to the public virtually.