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HHS/FDA

RIN: 0910-AF20

Publication ID: Fall 2006

Title: Revocation of the Status of Specific Products; Group A Streptococcus
Abstract: FDA issued 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: Completed Actions
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	12/02/2005	70 FR 72257
Direct Final Rule	12/02/2005	70 FR 72197
Final Action	04/21/2006	71 FR 20533

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