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HHS/FDA RIN: 0910-AF20 Publication ID: Fall 2005 
Title: Revocation of the Status of Specific Products; Group A Streptococcus 
Abstract: FDA is issuing a direct final rule and companion proposed rule to revoke 21 CFR 610.19, Status of specific products; Group A streptococcus. The products had been licensed by the National Institutes of Health prior to 1972, when regulatory authority over these products was transferred to FDA. The regulation prohibits the use of Group A streptococcus organisms and derivatives of Group A streptococcus as ingredients in Bacterial Vaccines and Bacterial Antigens with "No U.S. Standard of Potency." The regulation was written to apply to a group of products that are no longer on the market, namely, streptococcus vaccines and antigens with "No U.S. Standard of Potency" that were not purified. The regulation was never intended to refer to purified streptococcus vaccines, which were not developed at that time. Therefore, the regulation is being revoked. 
Agency: Department of Health and Human Services(HHS)  Priority: Info./Admin./Other 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 610.19 
Legal Authority: 42 USC 262 
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM - Companion to Direct Final Rule  10/00/2005   
Direct Final Rule  10/00/2005   
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
Agency Contact:
Paul E. Levine
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Suite 200N (HFM-17), Center for Biologics Evaluation and Research, Suite 200N (HFM-17), 1401 Rockville Pike,
Rockville, MD 20852
Phone:301 827-6210

 
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