[Printable PDF]
[Federal Register: May 14, 2004 (Volume 69, Number 94)]
[Rules and Regulations]
[Page 26768-26769]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14my04-6]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 600
[Docket No. 2003N-0528]
Revision of the Requirements for Spore-Forming Microorganisms;
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 1, 2004, for the direct final rule that appeared
in the
[[Page 26769]]
Federal Register of December 30, 2003 (68 FR 75116). The direct final
rule amends the biologics regulations by providing options to the
existing requirement for separate, dedicated facilities and equipment
for work with spore-forming microorganisms. This document confirms the
effective date of the direct final rule.
DATES: Effective date confirmed: June 1, 2004.
FOR FURTHER INFORMATION CONTACT: Valerie A. Butler, Center for
Biologics Evaluation and Research (HFM-17), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-
6210.
SUPPLEMENTARY INFORMATION: In the Federal Register of December 30, 2003
(68 FR 75116), FDA issued a direct final rule amending the biologics
regulations by providing options to the existing requirement for
separate, dedicated facilities and equipment for work with spore-
forming microorganisms. The regulations were amended due to advances in
facility, system, and equipment design and in sterilization
technologies that allow work with spore-forming microorganisms to be
performed in multiproduct manufacturing areas.
FDA solicited comments concerning the direct final rule for a 75-
day period ending March 15, 2004. FDA stated that the effective date of
the direct final rule would be on June 1, 2004, unless any significant
adverse comment was submitted to FDA during the comment period. FDA
received only one comment (from private industry) on the direct final
rule. The comment requested FDA to revise Sec. 600.11(e)(4) (21 CFR
600.11(e)(4)), and asked whether this rulemaking affects the
interpretation of Sec. 600.11(e)(4). That comment is beyond the scope
of this rulemaking, which is not intended to affect the requirements
for live vaccine processing set forth in Sec. 600.11(e)(4). FDA has
determined that the received comment is not a significant adverse
comment.
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 amendments issued thereby
become effective on June 1, 2004.
Dated: May 7, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-11027 Filed 5-13-04; 8:45 am]
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