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HHS/FDA RIN: 0910-AC07 Publication ID: Spring 2002 
Title: Additional Safeguards for Children in Clinical Investigations of FDA Regulated Products 
Abstract: The final rule will finalize the interim rule that published in April 2001 and provide 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: Undetermined  Unfunded Mandates: Undetermined 
CFR Citation: 21 CFR 50; 21 CFR 56 
Legal Authority: 21 USC 321; 21 USC 343; 21 USC 346; 21 USC 346a; 21 USC 348; 21 USC 350a; 21 USC 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:
Action Source Description Date
Other  Statutory  The Children's Health Act of 2000 requires that, within six months of the date of its enactment on 10/17/2000, FDA adopt existing HHS regulations providing additional protections for children involved  04/17/2001 
Action Date FR Cite
Interim Rule  04/24/2001  66 FR 20589 
Final Rule  09/00/2002   
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: 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

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