0910-AF62 200604 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 On December 13, 1985, the Food and Drug Administration (FDA) proposed to amend the biologics regulations and proposed to classify the bacterial vaccines and toxoids on the basis of findings and recommendations of the Panel on Review of Bacterial Vaccines and Toxoids (the Panel). The Panel reviewed the safety, efficacy, and labeling of bacterial vaccines and toxoids with standards of potency, including anthrax vaccine absorbed, bacterial antitoxins, and immune globulins. After reviewing the Panel's report and comments on the proposal, FDA published a final rule and final order on January 5, 2004 (69 FR 255). On October 27, 2004, the United States District Court for the District of Columbia vacated the January 5, 2004, final rule and final order. On December 29, 2004 (69 FR 78280), FDA published a withdrawal of the January 5, 2004, final rule and final order. Concurrently with the withdrawal of the final rule and final order, FDA published again a proposed rule and proposed order (December 2004 proposal) (69 FR 78281) to provide notice and to give interested persons an opportunity to comment. Substantive, Nonsignificant Previously Published in The Unified Agenda Completed Actions No No 21 CFR 610.21 21 USC 321 21 USC 331 21 USC 351 to 353 21 USC 355 21 USC 360 21 USC 360c 21 USC 360d 21 USC 360h 21 USC 360i 21 USC 371 21 USC 372 21 USC 374 21 USC 381 42 USC 216 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 12/19/2005 70 FR 75018 Final Order 12/19/2005 70 FR 75180 No No None 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