Department of Health and Human Services April 17, 2023 – Federal Register Recent Federal Regulation Documents

In accordance with regulatory provisions, the Centers for Disease Control and Prevention (CDC) announces the following meeting for the Advisory Board on Radiation and Worker Health (ABRWH or the Advisory Board). This meeting is open to the public, but without a public comment period. The public is welcome to submit written comments in advance of the meeting, to the contact person below. Written comments received in advance of the meeting will be included in the official record of the meeting. The public is also welcomed to listen to the meeting by joining the teleconference (information below). The audio conference line has 150 ports for callers.

The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), is seeking nominations for membership on the Advisory Council for the Elimination of Tuberculosis (ACET). ACET consists of 10 experts including the Chair in fields associated with public health, epidemiology, immunology, infectious diseases, pulmonary disease, pediatrics, tuberculosis, microbiology, and preventive health care delivery.

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

The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) in response to an outbreak of mpox. FDA has issued an Authorization for an in vitro diagnostic device as requested by Cue Health, Inc. The Authorization contains, among other things, conditions on the emergency use of the authorized product. The Authorization follows the August 9, 2022, determination by the Secretary of Health and Human Services (HHS) that there is a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of U.S. citizens living abroad, and that involves monkeypox virus. On the basis of such determination, the Secretary of HHS declared, on September 7, 2022, that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of infection with the monkeypox virus, including in vitro diagnostics that detect and/or diagnose infection with non-variola Orthopoxvirus, pursuant to the FD&C Act, subject to terms of any authorization issued under that section. The Authorization, which includes an explanation of the reasons for issuance, is reprinted in this document.

The National Institutes of Health (NIH), Office of the Director, Office of Disease Prevention (ODP) is requesting public comment on its draft strategic plan for Fiscal Years 2024-2028 (FY24- 28), Prevention Research: Creating a Healthier Future for All. ODP invites feedback on its proposed priorities from prevention researchers in academia and industry, health care providers, patient advocacy organizations, community-based organizations, health service organizations, scientific or professional organizations, trainees and early-stage investigators, federal agencies, those employed by NIH or at institutions receiving NIH support, and the general public. Organizations are strongly encouraged to submit a single response that reflects the views of the organization and membership as a whole.

The Food and Drug Administration (FDA, the Agency, or we) is announcing a public workshop entitled ``Rare Disease Endpoint Advancement Pilot Program Workshop: Novel Endpoints for Rare Disease Drug Development.'' Convened by the Duke-Robert J. Margolis, MD Center for Health Policy (Duke-Margolis) and supported by a cooperative agreement between FDA and Duke-Margolis, the workshop will include discussions of the Rare Disease Endpoint Advancement (RDEA) Pilot Program and novel endpoint development for rare disease drug development.

On April 10, 2023, we published a collection of information notice in the Federal Register concerning our revised Managed Care Rate Setting Guidance. The notice included an incorrect web address for obtaining copies of the supporting statement, the revised guide, and supporting documents.