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HHS/FDA RIN: 0910-AC07 Publication ID: Fall 2008 
Title: Additional Safeguards for Children in Clinical Investigations 
Abstract: The final rule will finalize the interim final rule that published in April 2001, providing additional protections for children involved as subjects in clinical investigations of FDA-regulated products, as required by the Children's Health Act of 2000. 
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 56   
Legal Authority: 21 USC 321    21 USC 343    21 USC 346 to 346a    21 USC 348    21 USC 350a and 350b    21 USC 351 to 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    41 USC 216    41 USC 241    41 USC 262    41 USC 263b to 263n   
Legal Deadline:  None
Timetable:
Action Date FR Cite
Interim Final Rule  04/24/2001  66 FR 20589   
Final Action  06/00/2009    
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Carol Drew
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Suite 3037 (HFD-7), Center for Drug Evaluation and Research, WO 51, Room 6306, 10903 New Hampshire Avenue,
Silver Spring, MD 20993-0002
Phone:301 796-3601
Fax:301 847-8440