0910-AF20 200410 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Revocation of the Status of Specific Products; Group A Streptococcus 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 never intended to refer to purified streptococcus vaccines, which were not developed at that time. Therefore, the regulation is being revoked. Info./Admin./Other Previously Published in The Unified Agenda Proposed Rule Stage No No 21 CFR 610.19 42 USC 262 No NPRM - Companion to Direct Final Rule 05/00/2005 Direct Final Rule 05/00/2005 No No None No NA Not Collected Paul Levine E. 0910 Food and Drug Administration FDA 301 827-6210 Suite 200N (HFM-17), Center for Biologics Evaluation and Research, Suite 200N (HFM-17), 1401 Rockville Pike, Rockville MD 20852