Revocation of Status of Specific Products; Group A Streptococcus; Confirmation of Effective Date
Direct Final Rule; Confirmation Of Effective Date.
The Food and Drug Administration (FDA) is confirming the effective date of June 2, 2006, for the direct final rule that appeared in the Federal Register of December 2, 2005 (70 FR 72197). The direct final rule removes the regulation applicable to the status of specific products; Group A streptococcus. FDA is removing the regulation because the existing requirement for Group A streptococcus organisms and derivatives is both obsolete and a perceived impediment to the development of Group A streptococcus vaccines. This document confirms the effective date of the direct final rule.
2 actions from May 2005 to May 2005
- NPRM - Companion to Direct Final Rule
- Direct Final Rule
Table of Contents
DATES: Back to Top
Effective date confirmed: June 2, 2006.
FOR FURTHER INFORMATION CONTACT: Back to Top
Valerie A. Butler, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-6210.
SUPPLEMENTARY INFORMATION: Back to Top
In the Federal Register of December 2, 2005 (70 FR 72197), FDA solicited comments concerning the direct final rule for a 75-day period ending February 15, 2006. FDA stated that the effective date of the direct final rule would be on June 2, 2006, 6 months after the date of publication in the Federal Register, unless any significant adverse comment was submitted to FDA during the comment period. FDA did not receive any significant adverse comments. Therefore, FDA is removing from the regulation 21 CFR 610.19 because this provision is obsolete and a perceived impediment to the development of Group A streptococcus vaccines.
Authority: Back to Top
Therefore, under the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act and under authority delegated to the Commissioner of Food and Drugs, the amendment issued thereby becomes effective on June 2, 2006.
Dated: April 14, 2006.
Assistant Commissioner for Policy.
[FR Doc. 06-3790 Filed 4-20-06; 8:45 am]
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