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HHS/FDA

RIN: 0910-AF20

Publication ID: Spring 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 current regulation was based on the panel report for bacterial vaccines with No U.S. Standard of Potency." The vaccines had been licensed by the National Institutes of Health prior to 1972, when regulatory authority over these vaccines 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	09/00/2005
Direct Final Rule	09/00/2005

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