[Printable PDF]
[Federal Register: April 21, 2006 (Volume 71, Number 77)]
[Rules and Regulations]
[Page 20533-20534]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21ap06-7]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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this provision is obsolete and a perceived impediment to the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]
BILLING CODE 4160-01-S