0910-AC56 200310 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 The final rule amends the FDA biologics regulations in response to the report and recommendations of the Panel on Review of Bacterial Vaccines and Toxoids with Standards of Potency (the Panel). The Panel reviewed the safety, efficacy, and labeling of bacterial vaccines and toxoids with standards of potency, bacterial antitoxins, and immune globulins. On the basis of the Panel's findings and recommendations, FDA is classifying these products as Category I (safe, effective, and not misbranded), Category II (unsafe, ineffective, or misbranded), or Category IIIB (off the market pending completion of studies permitting a determination of effectiveness). 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 381 42 USC 216 42 USC 262 42 USC 263 42 USC 264 No NPRM 12/13/1985 50 FR 51002 NPRM Comment Period End 03/13/1986 Final Action 04/00/2004 No None NA Not Collected Astrid Szeto L. 0910 Food and Drug Administration FDA 301 827-6210 301 827-9434 astrid.szeto@fda.hhs.gov Suite 200N (HFM-17), Center for Biologics Evaluation and Research (HFM-17), 1401 Rockville Pike, Suite 200N, Rockville MD 20852-1448