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HHS/FDA RIN: 0910-AC35 Publication ID: Fall 2008 
Title: Toll-Free Number for Reporting Adverse Events on Labeling for Human Drugs 
Abstract: To require certain 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: Completed Actions 
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 
Timetable:
Action Date FR Cite
NPRM  04/22/2004  69 FR 21778   
NPRM Comment Period End  07/21/2004    
Interim Final Rule  01/03/2008  73 FR 402   
Final Action  10/28/2008  73 FR 63886   
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: Federal, State 
Small Entities Affected: Businesses  Federalism: Yes 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: 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