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HHS/FDA RIN: 0910-AG32 Publication ID: Fall 2010 
Title: Informed Consent Elements  
Abstract: The rule is to implement section 801(b)(3)(A) of the Food and Drug Administration Amendments Act of 2007. The provision requires the Food and Drug Administration to update its informed consent regulations to require inclusion in the informed consent documents and process a statement that clinical trial information for such clinical investigation has been or will be submitted for inclusion in the registry data bank pursuant to subsection (j) of section 402 of the Public Health Service Act (PHSA). The regulation will require the insertion of a specific statement in all informed consent documents that, if applicable, the clinical trial information for such clinical investigation has been or will be submitted for inclusion in the registry data bank pursuant to subsection (j) of section 402 of the PHSA. 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 50.25   
Legal Authority: 21 USC 355(i)(4)    21 USC 360j(g)(3)(D)    21 USC 371(a)    secs 505(i), 520(g), and 701(a), FD&C Act   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  12/29/2009  74 FR 68750   
NPRM Comment Period End  03/01/2010    
Final Action  12/00/2010    
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: Federal 
Small Entities Affected: Businesses, Organizations  Federalism: No 
Included in the Regulatory Plan: No 
International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.
RIN Data Printed in the FR: No 
Agency Contact:
Jarilyn Dupont
Director of Regulatory Policy
Department of Health and Human Services
Food and Drug Administration
WO Building 32, Room 4245, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:301 796-4830
Fax:301 847-3541
Email: jarilyn.dupont@fda.hhs.gov