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HHS/CDC RIN: 0920-AA31 Publication ID: Spring 2011 
Title: Possession, Use, and Transfer of Select Agents and Toxins (Sars-CoV) 
Abstract: The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 authorizes the HHS Secretary to regulate the possession, use, and transfer of select agents and toxins that have the potential to pose a severe threat to public health and safety. These regulations are set forth at 42 CFR 73. Criteria used to determine whether a select agent or toxin should be included under the provisions of these regulations are based on: (1) The effect on human health as a result of exposure to the agent or toxin, (2) the degree of contagiousness of the agent or toxin, (3) the methods by which the agent or toxin is transferred to humans, (4) the availability and effectiveness of pharmacotherapies and immunizations to treat and prevent any illness resulting from infection by the agent or toxin, and (5) any other criteria, including the needs of children and other vulnerable populations that the HHS Secretary considers appropriate. We are proposing this action because SARS-CoV (1) causes significant mortality, especially in the elderly; (2) has the capability to easily transmit from human to human; (3) there is currently no method to treat or prevent infections caused by the SARS-CoV virus; and (4) it has been documented that the virus persists in the environment. 
Agency: Department of Health and Human Services(HHS)  Priority: Economically Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Completed Actions 
Major: Yes  Unfunded Mandates: No 
CFR Citation: 42 CFR 73.3   
Legal Authority: PL 107-188   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  07/13/2009  74 FR 33401   
NPRM Comment Period End  09/11/2009    
Merged With 0920-AA34  05/01/2011    
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Related RINs: Merged with 0920-AA34 
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