0910-AB61 200304 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Supplements and Other Changes to an Approved Application Other Significant Previously Published in The Unified Agenda Final Rule Stage No No 21 CFR 314 21 USC 356a No NPRM 06/28/1999 64 FR 34608 Final Action 10/00/2003 No None No NA Not Collected Howard Muller P. 0910 Food and Drug Administration FDA 301 796-3601 301 847-8440 howard.mullerjr@fda.hhs.gov Suite 3037 (HFD-7), Center for Drug Evaluation and Research, WO 51, Room 6234, 10903 New Hampshire Avenue, Silver Spring MD 20993-0002