0910-AA97 199810 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 Adverse Drug Reaction Reporting Requirements for Human Drug and Biological Products Other Significant Previously Published in The Unified Agenda Proposed Rule Stage Undetermined Undetermined 21 CFR 20 21 CFR 310 21 CFR 312 21 CFR 314 21 CFR 600 21 USC 216 21 USC 262 21 USC 263 21 USC 263a 21 USC 264 21 USC 300aa 21 USC 321 21 USC 331 21 USC 351 to 353 21 USC 355 to 357 21 USC 371 21 USC 374 No NPRM 02/00/1999 NPRM Comment Period End 05/00/1999 Undetermined Undetermined NA Not Collected Audrey Thomas A. 0910 Food and Drug Administration FDA 301 796-3601 301 847-8440 audrey.thomas@fda.hhs.gov Suite 3037 (HFD-7), Center for Drug Evaluation and Research, WO 51, Room 6364, 10903 New Hampshire Avenue, Silver Spring MD 20993-0002 Not Procurement Related No