Department of Health and Human Services May 23, 2024 – 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 81st full council meeting on Wednesday, June 5-Thursday, June 6, 2024. The meeting will include panels on the state of HIV science; agencies' perspectives on ending the HIV epidemic; State-level system approaches from health departments; and anti-LGBTQI+ laws and their impact nationally & globally. It will be open to the public and 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 Tuesday, May 28, 2024. 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 Thursday, June 13, 2024. 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 Food and Drug Administration (FDA or Agency) is announcing the availability of a draft revised guidance for industry (GFI) #115 (VICH GL22) entitled "Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Reproduction Testing (Revision 1)." This draft guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). In order to establish the safety of veterinary drug residues in human food, a number of toxicological evaluations are required, including the assessment of any effects on reproduction. The objective of this guidance is to ensure international harmonization of reproduction testing that is appropriate for the evaluation of effects on reproduction from long-term, low-dose exposures; these effects may be encountered from the presence of veterinary drug residues in food.

The Secretary of Health and Human Services (Secretary) announces a meeting of the Interdepartmental Substance Use Disorders Coordinating Committee (ISUDCC). The ISUDCC is open to the public and members of the public can attend the meeting via telephone or webcast only, and not in person. Agenda with call-in information will be posted on the SAMHSA website prior to the meeting at: https://www.samhsa.gov/about-us/advisory- councils/meetings. The meeting's focus will be on the draft report of the ISUDCC's recommendations on how the Federal Government can further integrate and coordinate harm reduction approaches and strategies across the continuum of prevention, treatment, and recovery policies, programs, and practices. This meeting will also include presentations on the recently released Harm Reduction Framework, the Naloxone Saturation Academies, and SAMHSA's Overdose Prevention and Response Toolkit. Committee Name: Interdepartmental Substance Use Disorders Coordinating Committee (ISUDCC).

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) hereby gives notice that the National Vaccine Advisory Committee (NVAC) will hold an in-person meeting. The meeting will be open to the public and public comment will be heard during the meeting.