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HHS/FDA RIN: 0910-AA89 Publication ID: Fall 2003 
Title: Determination That Informed Consent Is Infeasible or Is Contrary to the Best Interest of Recipients 
Abstract: The final rule would establish criteria and standards for the President to apply in making a determination that informed consent is not feasible or is contrary to the best interest of military personnel engaged in specific military operations. Under Federal law, the President is authorized to waive the Federal Food, Drug, and Cosmetic Act's informed consent requirements in military operations, if the President finds that obtaining consent is infeasible, contrary to the best interests of recipients, or contrary to national security interests. 
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    21 CFR 312   
Legal Authority: 21 USC 321    21 USC 346    21 USC 346a    21 USC 348    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  10/05/1999  64 FR 54180   
Final Action  01/00/2004    
Regulatory Flexibility Analysis Required: No  Government Levels Affected: Federal 
Federalism: No 
Included in the Regulatory Plan: No 
Agency Contact:
Philip L. Chao
Senior Policy Analyst
Department of Health and Human Services
Food and Drug Administration
Room 15-61 (HF-23), Office of Policy and Planning (HF-23), Room 14C-17, 5600 Fishers Lane,
Rockville, MD 20857
Phone:301 827-0587
Fax:301 827-4774
Email: philip.chao@fda.hhs.gov

 
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