Saturday, December 7, 2024

OMB Approves CDC Final Rule on Select Agents and Toxins Update

Yesterday the OMB’s Office of Information and Regulatory Affairs (OIRA) announced that it had approved a final rule from the HHS’ Centers for Disease Control and Prevention (CDC) on “Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review of the List of Select Agents and Toxins”. This rulemaking is typically coordinated the USDA’s APHIS final rule on “Biennial Review and Republication of the Select Agent and Toxin List” which was recently approved by OMB. This final rule was sent to OIRA on October 3rd, 2024. An advanced notice of proposed rulemaking (ANPRM) was published on March 17th, 2020. The notice of proposed rulemaking (NPRM) was published on January 30th, 2024.

According to the Spring 2024 Unified Agenda entry for this rulemaking:

“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. This final rule concludes the biennial review and republication of the list of biological agents and toxins regulated by HHS.”

I will probably not be covering these two select agent rules in any detail here. I will at least include a note in the appropriate ‘Short Takes’ post when they are published. 

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