Department of Health and Human Services September 14, 2018 – Federal Register Recent Federal Regulation Documents

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the Advisory Committee on Minority Health (ACMH) will hold a meeting conducted as a telephone conference call. This call will be open to the public. Preregistration is required for both public participation and comment. Any individual who wishes to participate in the call should email OMH-ACMH@hhs.gov by October 11, 2018. Instructions regarding participating in the call and how to provide verbal public comments will be given at the time of preregistration. Information about the meeting is available from the designated contact and will be posted on the website for the Office of Minority Health (OMH), www.minorityhealth.hhs.gov. Information about ACMH activities can be found on the OMH website under the heading About OMH.

The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific guidances. The guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products'' that explained the process that would be used to make product-specific guidances available to the public on FDA's website. The guidances identified in this notice were developed using the process described in that guidance.

In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Subcommittee for Procedure Reviews (SPR) of the Advisory Board on Radiation and Worker Health (ABRWH). 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 welcome to listen to the meeting by joining the audio conference (information below). The audio conference line has 150 ports for callers.

The Departments of Agriculture and Health and Human Services published a document in the Federal Register of September 6, 2018 concerning solicitation of nominations for membership on the 2020 Dietary Guidelines Advisory Committee. The document contained incorrect dates.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``510(k) Third-Party Review Program; Draft Guidance for Industry, Food and Drug Administration Staff, and Third-Party Review Organizations.'' This draft guidance provides a comprehensive look into FDA's current thinking regarding the 510(k) Third-Party (3P) Review Program authorized under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Under the FDA Reauthorization Act of 2017 (FDARA), FDA was directed to issue draft guidance on the factors that will be used in determining whether a class I or class II device type, or subset of such device types, is eligible for review by an accredited person. The 3P Review Program is intended to allow review of devices by 3P Review Organizations to provide manufacturers of these devices an alternative review process that allows FDA to best utilize our resources on higher risk devices. This draft guidance is not final nor is it in effect at this time.

The Administration for Community Living (ACL) announces the intent to award a single-source supplement to the current cooperative agreement held by Meals on Wheels America for the project Enhancing the Knowledge and Skills of the Aging Network.