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HHS/CDC RIN: 0920-AA24 Publication ID: Fall 2008 
Title: ●Possession, Use, and Transfer of Select Agents and Toxins 
Abstract: The biological agents and toxins listed in section 73.3 of title 42 of the Code of Federal Regulations have been determined by the Secretary of the U.S. Department of Health and Human Services (HHS) to have the potential to pose a severe threat to public health and safety. On October 20, 2005, we published in the Federal Register an interim final rule adding the reconstructed replication competent forms of the 1918 pandemic influenza virus containing any portion of the coding regions of all eight gene segments to the list of HHS select agents and toxins. Based on public comments we received, we are proposing to revise the entry for the 1918 pandemic influenza virus from “reconstructed replication competent forms of the 1918 pandemic influenza virus containing any portion of the coding regions of all eight gene segments” to “Chimeric influenza viruses containing gene segments from the 1918 pandemic influenza strain.” We are also proposing to add SARS-associated coronavirus (SARS-CoV) to the list of HHS select agents and toxins. We are proposing this action because SARS-CoV (1) causes significant mortality, especially in the elderly; (2) has the capability of easily being transmitted 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 may persist in the environment. 
Agency: Department of Health and Human Services(HHS)  Priority: Economically Significant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Long-Term Actions 
Major: Undetermined  Unfunded Mandates: No 
CFR Citation: 42 CFR 73.3   
Legal Authority: PL 107-188   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  To Be Determined    
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