0920-AA71 202504 Unified Agenda of Federal Regulatory and Deregulatory Actions 0920 Centers for Disease Control and Prevention CDC 0900 Department of Health and Human Services HHS Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review of the List of Select Agents and Toxins

The Bioterrorism Preparedness Act requires that the Department of Health and Human Services (HHS) Secretary review and republish the list of select agents and toxins on at least a biennial basis. CDC published an Advanced Notice of Proposed Rulemaking in 2020 and a Notice of Proposed Rulemaking in January 2024. HHS finalized one part of the January 2024 proposed rule in December 2024, and it focused on changes to the select agents and toxins list. The second final rule will focus on administrative and programmatic changes to ensure enhanced biosafety and biosecurity of select agents and toxins. These regulations have significant national security implications to prevent bioterrorism and biowarfare, mitigate insider threat and biosecurity concerns, and protect critical infrastructure for pandemic preparedness.

]]> Other Significant Previously Published in The Unified Agenda Final Rule Stage No No Other 42 CFR 73 Pub. L. 107-188 No ANPRM 03/17/2020 85 FR 15087 ANPRM Comment Period End 05/18/2020 NPRM 01/30/2024 89 FR 5823 NPRM Comment Period End 04/01/2024 Final Rule 12/17/2024 89 FR 101941 Final Rule Effective 01/16/2025 Final Rule 05/00/2026 No No Federal Local State No No No No Shelley Jorgensen Director, Division of Regulatory Science and Compliance 0920 Centers for Disease Control and Prevention CDC 404 718-2000 lrsat@cdc.gov 1600 Clifton Road NE, H21-54, Atlanta GA 30329