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HHS/FDA RIN: 0910-AC35 Publication ID: Spring 2002 
Title: ●Section 17 Best Pharmaceuticals for Children Act 
Abstract: To require drug product labeling to include a toll-free number for reports of adverse events regarding drug products, and a statement that the number is to be used for reporting purposes only and not to receive medical advice. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: Undetermined  Unfunded Mandates: No 
CFR Citation: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations.
Legal Authority: 21 USC 355a 
Legal Deadline:
Action Source Description Date
Final  Statutory    01/04/2003 
Timetable:
Action Date FR Cite
Interim Final Rule  12/00/2002   
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
Agency Contact:
Ann L. Simoneau
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Suite 3037, HFD-7, 1451 Rockville Pike,
Rockville, MD 20852
Phone:301 594-2041
Fax:301 827-5562

 
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