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HHS/FDA RIN: 0910-AC25 Publication ID: Spring 2008 
Title: Exception From General Requirements for Informed Consent; Request for Comments and Information 
Abstract: This final rule will add an 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. 
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 
CFR Citation: 21 CFR 50.23 
Legal Authority: 21 USC 321; 21 USC 343; 21 USC 346; 21 USC 346a; 21 USC 348; 21 USC 350a; 21 USC 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
Timetable:
Action Date FR Cite
Interim Final Rule  06/07/2006  71 FR 32827 
Final Action  12/00/2008   
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
Email: claudia.gaffey@fda.hhs.gov

 
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