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HHS/FDA RIN: 0910-AC35 Publication ID: Fall 2004 
Title: Toll-Free Number for Reporting Adverse Events on Labeling for Human Drugs 
Abstract: To require the labeling of human drugs approved under section 505 of the Federal Food, Drug, and Cosmetic Act to include a toll-free number for reports of adverse events, 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: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 201    21 CFR 208    21 CFR 209   
Legal Authority: 21 USC 355b   
Legal Deadline:
Action Source Description Date
Final  Statutory    01/04/2003 

Statement of Need: Consumers may not be aware of FDA's adverse event reporting program under Medwatch. This requirement will promote FDA's mission to protect the public health by informing consumers of FDA's Medwatch system.

Summary of the Legal Basis: Section 17 of the Best Pharmaceuticals for Children Act (BPCA) requires a final rule to issue within one year of the date of its enactment on January 4, 2002.

Alternatives: This rule is required by section 17 of the BPCA. FDA has considered alternatives within the scope of the statutory requirements, in particular, ways to reach the broadest consumer audience and to minimize costs to the pharmacy profession.

Anticipated Costs and Benefits: Anticipated costs are to drug manufacturers and authorized dispensers of drug products, including pharmacies. The BPCA contains a provision requiring the Secretary to seek to minimize the cost to the pharmacy profession. Anticipated benefits are to obtain information about adverse events from consumers, which may inform FDA of trends in reported adverse events and result in a review of the safety and/or effectiveness of particular drug products on the market.

Risks: None.

Action Date FR Cite
NPRM  04/22/2004  69 FR 21778   
NPRM Comment Period End  07/21/2004    
Final Action  05/00/2005    
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: Yes 
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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