[Federal Register Volume 69, Number 94 (Friday, May 14, 2004)]
[Rules and Regulations]
[Pages 26768-26769]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-11027]


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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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