Department of Health and Human Services August 24, 2023 – Federal Register Recent Federal Regulation Documents

As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Service is hereby giving notice that the Presidential Advisory Council on HIV/AIDS (PACHA or the Council) will convene the 78th full council meeting on Wednesday, September 20, 2023. The meeting will convene in Charleston, West Virginia and it will also utilize virtual technologies. The meeting will be open to the public. Due to limited space, pre-registration is encouraged for members of the public who wish to attend the meeting in-person. Please email your name to PACHA@hhs.gov by close of business Wednesday, September 13, 2023 to pre-reigster. There will be a public comment session during the meeting; pre-registration is required to provide public comment. To pre-register to provide public comment, please send an email to PACHA@hhs.gov and include your name, organization, and title by close of business Wednesday, September 13, 2023. If you decide you would like to provide public comment but do not pre-register, you may submit your written statement by emailing PACHA@hhs.gov by close of business September 27, 2023. The meeting agenda will be posted on the PACHA page on HIV.gov at https://www.hiv.gov/federal-response/pacha/about-pacha prior to the meeting.

The Office of the Assistant Secretary for Health (OASH) is seeking nominations for membership on the Presidential Advisory Council on HIV/AIDS (referred to as PACHA and/or the Council). The PACHA is a federal advisory committee within the U. S. Department of Health and Human Services (HHS). Management support for the activities of this Council is the responsibility of the OASH. The qualified individuals will be nominated to the Secretary of Health and Human Services for consideration for appointment as members of the PACHA. Members of the Council, including the Chair, are appointed by the Secretary. Members are invited to serve for overlapping terms of up to four-year; terms of more than two years are contingent upon the authorized continuation of the Council. The Council was established to provide advice, information, and recommendations to the Secretary regarding programs, policies, and research to promote effective treatment, prevention and cure of HIV and AIDS, including considering common co-morbidities, as needed to promote effective HIV diagnosis, treatment, prevention, and quality care services. The functions of the Council are solely advisory in nature.

The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) announces an alternative form of hearing regarding the Center for Drug Evaluation and Research's (CDER's) proposal to refuse to approve ITCA 650 (exenatide in DUROS device), a drug-device combination product that is the subject of a new drug application (NDA) submitted by Intarcia Therapeutics, Inc. (Intarcia). CDER is holding a public hearing before an advisory committee under FDA regulations as an alternative form of hearing.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Endocrinologic and Metabolic Drugs Advisory Committee (the Committee). The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

The Substance Abuse and Mental Health Services Administration (SAMHSA) within the Department of Health and Human Services (HHS), is soliciting applications from qualified individuals or organizations to be considered for non-voting representative positions on the Maternal Mental Health Task Force subcommittee of the Advisory Committee for Women's Services (ACWS) (ACWS Subcommittee), as authorized in the Consolidated Appropriations Act. This notice solicits additional representatives.