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HHS/FDA RIN: 0910-AG71 Publication ID: 2012 
Title: Additional Safeguards for Children in Clinical Investigation of FDA-Regulated Products 
Abstract: FDA is finalizing a rule to amend its human subject protection regulations and institutional review board regulations. FDA is taking this action to provide additional safeguards for children enrolled in FDA-regulated clinical trials. 
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    21 CFR 56   
Legal Authority: 21 USC 343    21 USC 350a    21 USC 350b    21 USC 352 to 353    21 USC 355    21 USC 360j    21 USC 371    42 USC 262   
Legal Deadline:  None
Timetable:
Action Date FR Cite
Interim Final Rule  04/24/2001  66 FR 20589   
Final Action  12/00/2012 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: Federal 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Robert "Skip" Nelson
Lead Medical Officer
Department of Health and Human Services
Food and Drug Administration
WO 32, Room 5126, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:301 796-8665
Email: robert.nelson@fda.hhs.gov