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HHS/FDA RIN: 0910-AF62 Publication ID: Spring 2005 
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, 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 (69 FR 78281) to provide notice and to give interested persons an opportunity to comment. FDA is proposing to amend the biologics regulations in response to the report and recommendations of the Panel and in consideration of comments submitted to the Division of Dockets Management. FDA intends to classify 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). 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 201.59; 21 CFR 610.21 
Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 358; 21 USC360; 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 
Legal Deadline:  None
Action Date FR Cite
NPRM  12/29/2004  69 FR 78281 
NPRM Comment Period End  03/29/2005   
Final Action  07/00/2005   
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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