E8-4471. 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.

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.

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.