Department of Health and Human Services August 28, 2023 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry entitled ``Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic ActCompliance Policies.'' This guidance describes FDA's compliance policies regarding enforcement of requirements for the interoperable, electronic, package level product tracing (referred to as enhanced drug distribution security requirements) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) that will go into effect on November 27, 2023. FDA believes the compliance policies outlined in this guidance will help supply chain stakeholders, particularly trading partners, by accommodating the additional time that may be needed to continue to develop and refine appropriate systems and processes to conduct interoperable, electronic tracing at the package level, to achieve robust supply chain security under the Drug Supply Chain Security Act (DSCSA) while helping ensure continued patient access to prescription drugs.

In accordance with regulatory provisions, the Centers for Disease Control and Prevention (CDC) announces the following meeting for the Subcommittee on Procedures Reviews (SPR) of 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 audio conference (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 Board of Scientific Counselors, Center for Preparedness and Response, (BSC, CPR). The BSC, CPR consists of 11 experts in fields associated with business, crisis leadership, emergency response and management, informatics, laboratory science, medicine, mental and behavioral health, public health law, public health practice, risk communication, and social science.

In accordance with regulatory provisions, the Centers for Disease Control and Prevention (CDC) announces the following meeting of the Clinical Laboratory Improvement Advisory Committee (CLIAC). This is a hybrid meeting, accessible both in person and virtually. It is open to the public, limited only by the in-person space available. The public is also welcome to view the meeting by joining the audio conference (information below). Time will be available for public comment, and the public is also welcome to submit written comments in advance of the meeting (see the public participation section below).

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