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HHS/FDA RIN: 0910-AC25 Publication ID: Spring 2005 
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: 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 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
Interim Final Rule  09/00/2005    
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
Agency Contact:
Darin Achilles
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
14-101-11, 10903 New Hampshire Avenue, Document Control Center, Building 71, Room G335,
Silver Spring, MD 20993
Phone:877 287-1373
Fax:301 595-1426
Email: ctpregulations@fda.hhs.gov