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HHS/FDA RIN: 0910-AC25 Publication ID: Fall 2004 
Title: Exception From General Requirements for Informed Consent; Request for Comments and Information 
Abstract: FDA is proposing to 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: Long-Term Actions 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 50.23 
Legal Authority: 21 USC 321; 21 USC 351; 21 USC 352; 21 USC 355; 21 USC 360; 21 USC 360bbb; 21 USC 360c; 21 USC 360d; 21 USC 360e; 21 USC 360f; 21 USC 360h; 21 USC 360i; 21 USC 360j; 21 USC 371; 21 USC 381 
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  12/00/2005   
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
Agency Contact:
Gail Schmerfeld
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
14-101-11, 9200 Corporate Boulevard,
Rockville, MD 20850
Phone:877 287-1373
Fax:240 276-3904
Email: gail.schmerfeld@fda.hhs.gov

 
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