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HHS/CDC RIN: 0920-AA34 Publication ID: Fall 2011 
Title: Public Health Security and Bioterrorism Preparedness and Response Act of 2002; Biennial Review and Republication of the Select Agent and Toxin List 
Abstract: The Bioterrorism Preparedness Act requires that the HHS Secretary review and republish the list of select agents and toxins on at least a biennial basis. To assist with the biennial review, HHS reviewed recommendations provided by subject matter experts and the Intragovernmental Select Agents and Toxins Advisory Committee. In addition, on July 2, 2010, the President signed "Executive Order 13546: Optimizing the Security of Biological Select Agents and Toxins in the United States" to review, tier, and reduce the Select Agent List; establishing personal reliability standards for BSAT workers; and establishing physical security standards for identified Tier 1 select agents and toxins. This final rule implements the Executive Order and updates the list of select agents and toxins. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: None     (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: PL 107-188    42 USC 262(a)   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  10/03/2011  76 FR 61206   
NPRM Comment Period End  12/02/2011    
NPRM Comment Period Reopened  12/16/2011  76 FR 78215   
NPRM Comment Period Reopened End  01/17/2012    
Final Action  10/00/2012    
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Dr. Dan Sosin
Acting Director, Division of Select Agents and Toxins
Department of Health and Human Services
Centers for Disease Control and Prevention
1600 Clifton Road NE., MS A-46,
Atlanta, GA 30329
Phone:404 718-2000
Email: dms8@cdc.gov