Document ID: FDA-2008-N-0135-0001
Agency: fda
Document Type: Rule
Title: Revision of the Requirements for Live Vaccine Processing; Confirmation of Effective Date
Posted Date: 2008-03-07T05:00Z

[Federal Register: March 7, 2008 (Volume 73, Number 46)]
[Rules and Regulations]               
[Page 12262-12263]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07mr08-3]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 600

[Docket No. FDA-2008-N-0135] (formerly Docket No. 2007N-0284]

 
Revision of the Requirements for Live Vaccine Processing; 
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 March 18, 2008, for the direct final rule that 
appeared in the Federal Register of October 18, 2007 (72 FR 59000). The 
direct final rule amends the biologics regulations by providing options 
to the existing requirements for the processing of live vaccines. This 
document confirms the effective date of the direct final rule.

[[Page 12263]]

DATES: Effective date confirmed: March 18, 2008.

FOR FURTHER INFORMATION CONTACT: Stephen Ripley, 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 October 18, 2007 
(72 FR 59000), FDA solicited comments concerning the direct final rule 
for a 75-day period ending January 2, 2008. FDA stated that the 
effective date of the direct final rule would be on March 18, 2008, 75 
days after the end of the comment period, unless any significant 
adverse comment was submitted to FDA during the comment period. FDA 
received two letters of comment on the direct final rule. However, 
neither of these constitutes significant adverse comment. Therefore, 
FDA is confirming the effective date of the direct final rule. The two 
comments received were from private industry and an individual. The 
comments received and FDA's responses to the comments are discussed as 
follows:
    Both comments requested clarification of the change under the new 
21 CFR 600.11(e)(4)(i)(B), the language for which was taken directly 
from the existing 21 CFR 600.11(e)(4). One comment asked whether the 
requirements under this section are intended to cover research and 
development. The comment also asked for the definition of 
``microorganism'' and whether ``test'' refers to viral inactivation.
    The new provision mirrors the last sentence in the existing 
provision. The requirements under 21 CFR 600.11(e)(4)(i)(B) apply to 
buildings and equipment used for the manufacture of biological products 
regulated by FDA, not for research and development. We do not believe 
it is necessary to define the term ``microorganism,'' as this is a 
generally understood term, and is used throughout 21 CFR part 600. The 
terms ``test'' and ``test procedures'' do not refer to manufacturing 
steps such as viral inactivation.
    Another comment asked whether the industry practice of using 
biological indicators for equipment or materials sterilization 
qualification is consistent with the requirements in new 21 CFR 
600.11(e)(4)(i)(B).
    This direct final rule does not apply to microorganisms used as 
biological indicators for validation, qualification or monitoring of 
sterilization cycles. The rule does not change the requirements for 
those products set forth in 21 CFR 600.11(e)(2).
    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 March 18, 2008.

    Dated: February 29, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-4471 Filed 3-6-08; 8:45 am]

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