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HHS/CDC RIN: 0920-AA34 Publication ID: Spring 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: By statute, the HHS Secretary establishes by regulation a list of each biological agent and each toxin that has the potential to pose a severe threat to public health and safety. In determining whether to include an agent or toxin on the list, the HHS Secretary considers the effect on human health of exposure to an agent or toxin; the degree of contagiousness of the agent and the methods by which the agent or toxin is transferred to humans; the availability and effectiveness of pharmacotherapies and immunizations to treat and prevent illnesses resulting from an agent or toxin; the potential for an agent or toxin to be used as a biological weapon; and the needs of children and other vulnerable populations. 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 NPRM follows on the Advanced Notice of Proposed Rulemaking published July 21, 2010. In the NPRM, HHS is also requesting public comment on including the SARS virus and Chapare virus on the list relative to the proposed tiering 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 
EO 13771 Designation: uncollected 
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
Action Date FR Cite
NPRM  10/00/2011    
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