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HHS/CDC RIN: 0920-AA09 Publication ID: Fall 2004 
Title: ●Possession, Use, and Transfer of Select Agents and Toxins 
Abstract: Title II of subtitle B of Public Law 107-188, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), repeals, expands, and incorporates the Secretary's current authority to regulate the transfer of certain biological agents and toxins (select agents). The Bioterrorism Act specifies that the Secretary develop and biennially review a specified list of select agents. Safety procedures must be established and enforced for the possession, use, and transfer of the listed agents and toxins; access to select agents is limited to individuals and entities that pass background checks administered by the Attorney General. The Bioterrorism Act exempts certain information from disclosure under the Freedom of Information Act, including information that would identify the location of regulated entities or their security measures. Subtitle C of the Bioterrorism Act outlines the required interagency coordination between the Department of Health and Human Services and the Department of Agriculture regarding agents that are regulated by both departments (overlap agents). This action will bring to completion the Department’s rulemaking in this area. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 42 CFR 72    42 CFR 72.6   
Legal Authority: PL 107-188   
Legal Deadline:  None
Timetable:
Action Date FR Cite
Final Action  01/00/2005    
Additional Information: Under RIN 0920-AA08, this regulation published as an interim final rule on December 13, 2002, at 67 FR 76886. An amended interim final rule with a request for comments was also published on November 3, 2003, at 68 FR 62245. Subsequently, RIN 0920-AA08 was inadvertently completed in the april 2003 Unified Agenda.
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
Related RINs: Previously reported as 0920-AA08 
Agency Contact:
Mark Hemphill
Chief of Policy, Select Agent Program
Department of Health and Human Services
Centers for Disease Control and Prevention
MS E-79, 1600 Clifton Road,
Atlanta, GA 30333
Phone:404 498-2255