0910-AA97 200304 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Safety Reporting Requirements for Human Drug and Biological Products Other Significant Previously Published in The Unified Agenda Long-Term Actions Undetermined Undetermined 21 CFR 310 21 CFR 312 21 CFR 314 21 CFR 320 21 CFR 600 21 CFR 601 21 CFR 606 42 USC 216 42 USC 241 42 USC 242a 42 USC 262 42 USC 263 42 USC 263a-n 42 USC 264 42 USC 300aa 21 USC 321 21 USC 331 21 USC 351 to 353 21 USC 355 21 USC 360 21 USC 360b-j 21 USC 361a 21 USC 371 21 USC 374 21 USC 375 21 USC 379e 21 USC 381 Yes NPRM 03/14/2003 68 FR 12406 Final Rule To Be Determined Yes Businesses Undetermined No 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