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HHS/CDC RIN: 0920-AA71 Publication ID: Fall 2024 
Title: Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review of the List of Select Agents and Toxins 
Abstract:

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 to allow the public an additional opportunity to comment on potential changes to HHS’s list of select agents.  Further, CDC’s standard practice is to send email notices called SA-Grams to the regulated entities and Responsible Officials regarding changes and alerts concerning the Select Agent Program as well as announcements of opportunities to provide comment on proposed rules.  HHS will finalize the January 2024 proposed rule in two separate rulemakings: One final rule will focus on changes to the select agents and toxins list. The second final rule will focus on administrative and programmatic changes.

 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 42 CFR 73   
Legal Authority: Pub. L. 107-188   
Legal Deadline:  None
Timetable:
Action Date FR Cite
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  12/00/2024 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: Federal, Local, State 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Daniel A Singer
Acting Director, Division of Regulatory Science and Compliance
Department of Health and Human Services
Centers for Disease Control and Prevention
1600 Clifton Road NE, H21-4,
Atlanta, GA 30329
Phone:404 718-2000
Email: lrsat@cdc.gov