0910-AA97 200510 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 Safety Reporting Requirements for Human Drug and Biological Products This regulation is one component of the Secretary's initiative to reduce medical errors. The final rule would amend the expedited and periodic safety reporting regulations for human drugs and biological products to revise certain definitions and reporting formats as recommended by the International Conference on Harmonisation and to define new terms; to add to or revise current reporting requirements; to revise certain reporting time frames; and propose other revisions to these regulations to enhance the quality of safety reports received by FDA. Other Significant Previously Published in The Unified Agenda Final Rule Stage 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 to 263-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 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 Extension End 10/14/2003 Comment Review End 06/00/2006 Yes Businesses Undetermined NA 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