Department of Health and Human Services May 2, 2024 – Federal Register Recent Federal Regulation Documents

The National Advisory Committee on Seniors and Disasters (NACSD) will conduct a public meeting on Monday, May 20, 2024 (2:30 p.m.-4:30 p.m. ET). Notice of the meeting is required under Section 10(a)(2) of the Federal Advisory Committee Act (FACA). The NACSD is required by section 2811B of the Public Health Service Act (PHS) Act (42 U.S.C. 300hh-10c), as amended by the Pandemic and All-Hazards Preparedness and Advancing Innovation Act (PAHPAIA), Public Law 116-22, and governed by the provisions of the Federal Advisory Committee Act (FACA). The NACSD provides expert advice and guidance to the U.S. Department of Health and Human Services (HHS) regarding all-hazards public health and medical preparedness, response, and recovery activities related to meeting the unique needs of older adults. ASPR manages and convenes the NACSD on behalf of the Secretary of HHS. The NACSD will discuss and deliberate questions posed by ASPR on climate and health equity. Procedures for Public Participation: The public and expert stakeholders are invited to observe the meeting either in-person or virtually and pre-registration is required. The pre-registration link and a more detailed agenda will be available on the NACSD website. Anyone may submit questions and comments to the NACSD by email (NACSD@hhs.gov) before the meeting. American Sign Language translation and Communication Access Real-Time Translation will be provided. We would like to specifically seek input from the public on climate and health equity considerations in disaster training as well as opportunities and strategic priorities for national public health and medical preparedness, response, and recovery specific to the needs of older adults. Representatives from industry, academia, health professions, health care consumer organizations, non-federal government agencies, or community-based organizations may request up to five minutes to speak directly to the Committee. Requests to speak to the Committee will be approved in consultation with the Committee Chair and based on time available during the meeting. Requests to speak to the NACSD during the public meeting must be sent to NACSD@hhs.gov by close of business on May 15, 2024. Please provide the full name, credentials, official position(s), and relevant affiliations for the speaker and a brief description of the intended topic. Presentations that contain material with a commercial bias, advertising, marketing, or solicitations will not be allowed. A meeting summary will be available on the NACSD website post meeting.

The Administration for Community Living (ACL) announces the intent to award a single-source supplement to the current cooperative agreement held by the Puerto Rico Ombudsman Office for the Elderly (PROOE) for the project Puerto Rico Disaster Assistance Grant which is through the Older Americans Act, Disaster Assistance for State Units on Aging (SUAs) and Tribal Organizations in Major Disasters Declared by the President and the Consolidated Appropriations Act, 2023.

The Food and Drug Administration (FDA) is requesting nominations for a nonvoting representative of the interests of the tobacco growers to serve on the Tobacco Products Scientific Advisory Committee (TPSAC), in the Center for Tobacco Products. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore encourages nominations of appropriately qualified candidates from these groups. A nominee may either be self-nominated or nominated by an organization. In addition, FDA is requesting that any industry organizations interested in participating in the selection of a nonvoting representative of the interests of the tobacco growers industry to serve on the TPSAC, notify FDA in writing. Nominations will be accepted for either the representative to serve on TPSAC or for the selection group effective with this notice.

In accordance with the requirements of the Privacy Act of 1974, as amended, the U.S. Department of Health and Human Services (HHS) is establishing two new systems of records that will be maintained by the Administration for Children and Families (ACF), Office on Trafficking in Persons (OTIP): System No. 09-80-0391, Anti- Trafficking Information Management System (ATIMS) Records; and System No. 09-80-0392, National Human Trafficking Training and Technical Assistance Center (NHTTAC) Participant Records.

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry (GFI) #187A entitled "Heritable Intentional Genomic Alterations in Animals: Risk-Based Approach." This guidance is intended to clarify FDA's requirements and recommendations with respect to heritable intentional genomic alterations (IGAs) in animals. The guidance is being issued as one of two companion documents. This guidance, entitled "Heritable Intentional Genomic Alterations in Animals: Risk-Based Approach," describes FDA's risk-based regulatory approach to the oversight of heritable IGAs in animals. This means that for people or companies developing certain types of IGAs in animals, FDA may not expect them to submit an application or get approval before marketing their product. For other types of IGAs in animals that do go through the approval process, the companion draft guidance document, GFI #187B entitled "Heritable Intentional Genomic Alterations in Animals: The Approval Process" describes how the approval process applies to heritable IGAs in animals.