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HHS/FDA RIN: 0910-AC25 Publication ID: Fall 2009 
Title: Exception From General Requirements for Informed Consent; Request for Comments and Information 
Abstract: This final rule will affirm the interim final rule's exception from the general requirement for informed consent in certain circumstances involving the use of investigational in vitro diagnostic devices to identify chemical, biological, radiological, or nuclear agents in a potential terrorist event or other public health emergency. The agency is issuing this rule because it is concerned that, during a potential terrorism event or other public health emergency, delaying testing of specimens to obtain informed consent may threaten the life of the subjects or others who have been exposed to or who may be at risk of exposure to a chemical, biological, radiological, or nuclear agent. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
EO 13771 Designation: uncollected 
CFR Citation: 21 CFR 50.23   
Legal Authority: 21 USC 321    21 USC 343    21 USC 346 to 346a    21 USC 348    21 USC 350a to 350b    21 USC 352    21 USC 353    21 USC 355    21 USC 360    21 USC 360c to 360f    21 USC 360h to 360j    21 USC 371    21 USC 379e    21 USC 381    42 USC 216    42 USC 241    42 USC 262    42 USC 263b to 263n   
Legal Deadline:  None
Action Date FR Cite
Interim Final Rule  06/07/2006  71 FR 32827   
Interim Final Rule Comment Period End  08/07/2006    
Final Action  09/00/2010    
Regulatory Flexibility Analysis Required: No  Government Levels Affected: State 
Small Entities Affected: No  Federalism: Yes 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Claudia M. Gaffey
Medical Officer
Department of Health and Human Services
Food and Drug Administration
Room 314/HFZ-314, Center for Devices and Radiological Health, WO66, Room 5516, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:301 796-6196
Fax:301 847-8144