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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