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HHS/FDA RIN: 0910-AF62 Publication ID: Spring 2006 
Title: Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review 
Abstract: 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. 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Completed Actions 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 610.21   
Legal Authority: 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   
Legal Deadline:  None
Action Date FR Cite
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   
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
Agency Contact:
Astrid L. Szeto
Senior Regulatory Review Officer
Department of Health and Human Services
Food and Drug Administration
Center for Biologics Evaluation and Research, 1401 Rockville Pike, Suite 200N, HFM-17,
Rockville, MD 20852
Phone:301 827-6210
Fax:301 827-9434

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