0910-AF62 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 Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review Substantive, Nonsignificant Previously Published in The Unified Agenda Final Rule Stage No No 21 CFR 201.59 21 CFR 610.21 21 USC 321 21 USC 331 21 USC 351 to 353 21 USC 355 21 USC 358 21 USC 360 21 USC 360b to 360d 21 USC 360h 21 USC 360i 21 USC 360gg to 360ss 21 USC 371 21 USC 372 21 USC 374 21 USC 379e 21 USC 381 42 USC 216 42 USC 241 42 USC 262 42 USC 263 42 USC 263a 42 USC 264 No NPRM 12/29/2004 69 FR 78281 NPRM Comment Period End 03/29/2005 Final Action 12/00/2005 No No None No NA Not Collected Astrid Szeto L. 0910 Food and Drug Administration FDA 301 827-6210 301 827-9434 Center for Biologics Evaluation and Research, 1401 Rockville Pike, Suite 200N, HFM-17, Rockville MD 20852