0910-AC35 200804 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 Other Significant Previously Published in The Unified Agenda Final Rule Stage No No 21 CFR 201 21 CFR 208 21 CFR 209 21 USC 355b Statutory Final 01/04/2003 No 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 12/00/2008 Yes Businesses None No Yes 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