[Federal Register Volume 71, Number 77 (Friday, April 21, 2006)]
[Rules and Regulations]
[Pages 20533-20534]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-3790]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 610

[Docket No. 2005N-0355]
RIN 0910-AF20


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Direct final rule; confirmation of effective date.

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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.

DATES: Effective date confirmed: June 2, 2006.

FOR FURTHER INFORMATION CONTACT: 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: 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this provision is obsolete and a perceived impediment to the 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: 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.


[[Page 20534]]


    Dated: April 14, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 06-3790 Filed 4-20-06; 8:45 am]
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