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Rule

Revocation of Status of Specific Products; Group A Streptococcus; Confirmation of Effective Date

Action

Direct Final Rule; Confirmation Of Effective Date.

Summary

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.

Unified Agenda

Revocation of the Status of Specific Products; Group A Streptococcus

2 actions from May 2005 to May 2005

  • May 2005
    • NPRM - Companion to Direct Final Rule
  • May 2005
    • 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 Therefore, FDA is removing from the regulation 21 CFR 610.19 because this provision is obsolete and a perceived impediment to the development of Group A streptococcus vaccines.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.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 06-3790 Filed 4-20-06; 8:45 am]

BILLING CODE 4160-01-S

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