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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.