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HHS/FDA RIN: 0910-AC56 Publication ID: Spring 2003 
Title: ●Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review 
Abstract: 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). 
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; 21 USC 352; 21 USC 353; 21 USC 355; 21 USC 358; 21 USC 360; 21 USC 360b; 21 USC 360c; 21 USC 360d; 21 USC 360h; 21 USC 360i; 21 USC 360gg-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
Timetable:
Action Date FR Cite
NPRM  12/13/1985  50 FR 51002 
NPRM Comment Period End  03/13/1986   
Final Action  03/00/2004   
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
Agency Contact:
Astrid L. Szeto
Director Regulatory Review Officer
Department of Health and Human Services
Food and Drug Administration
Suite 200N (HFM-17), Center for Biologics Evaluation and Research (HFM-17), 1401 Rockville Pike, Suite 200N,
Rockville, MD 20852-1448
Phone:301 827-6210
Fax:301 827-9434
Email: astrid.szeto@fda.hhs.gov

 
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