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HHS/FDA

RIN: 0910-AC35

Publication ID: Fall 2007

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 (To search for a specific CFR, visit the Code of Federal Regulations.)
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    Final Action  01/00/2008

Regulatory Flexibility Analysis Required: Yes	Government Levels Affected: None
Small Entities Affected: Businesses	Federalism: No
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, 10903 New Hampshire Ave., Bldg. 51, rm. 6306, Silver Spring, MD 20993-0002 Phone:301 796-3601 Fax:301-847-8440