0910-AC35 200310 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Toll-Free Number for Reporting Adverse Events on Labeling for Human Drugs 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. Other Significant Previously Published in The Unified Agenda Proposed Rule Stage No No 21 CFR 201 21 CFR 208 21 CFR 209 21 USC 355b Statutory Final 01/04/2003 Yes 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. 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. 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 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. None. NPRM 03/00/2004 Yes Businesses None NA Not Collected Carol Drew 0910 Food and Drug Administration FDA 301 796-3601 301 847-8440 Suite 3037 (HFD-7), Center for Drug Evaluation and Research, WO 51, Room 6306, 10903 New Hampshire Avenue, Silver Spring MD 20993-0002