0910-AG13 201004 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Premarketing Safety Reporting Requirements for Human Drug and Biological Products Other Significant Previously Published in The Unified Agenda Final Rule Stage No No 21 CFR 312 21 CFR 320 42 USC 216 42 USC 241 42 USC 242a 42 USC 262 and 263 42 USC 263a to 263n 42 USC 264 42 USC 300aa 21 USC 321 21 USC 331 21 USC 351 to 353 21 USC 355 21 USC 360b to 360j 21 USC 361a 21 USC 371 21 USC 374 21 USC 375 21 USC 379e 21 USC 381 No NPRM 03/14/2003 68 FR 12406 NPRM Comment Period Extended 06/18/2003 NPRM Comment Period End 07/14/2003 NPRM Comment Period Extended End 10/14/2003 Final Action 09/00/2010 No Businesses None No No No 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