E9-20119. Revision of the Requirements for Publication of License Revocation; 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 September 17, 2009, for the direct final rule that appeared in the Federal Register of May 5, 2009 (74 FR 20583). The direct final rule amends the biologics regulations to clarify the regulatory procedures for notifying the public about the revocation of a biologics license. The rule provides that FDA will publish a notice in the Federal Register following revocation of a biologics license under FDA regulations and will include a statement of the specific grounds for the revocation. This document confirms the effective date of the direct final rule.

DATES:

Effective date confirmed: September 17, 2009.

FOR FURTHER INFORMATION CONTACT:

Paul E. Levine, Jr., 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 May 5, 2009 (74 FR 20583), FDA issued a direct final rule amending the biologics regulations for notifying the public about the revocation of a biologics license by clarifying that FDA will publish a notice of license revocation in cases where the Commissioner has made a finding that reasonable grounds for revocation exist under 21 CFR 601.5(b). The rule, as amended, does not affect other regulations or procedures for notification of license revocation. The rule, as amended, also does not affect existing FDA practices for publishing notices of voluntary withdrawal, including notices of voluntary withdrawal of new drug applications.

FDA solicited comments concerning the direct final rule for a 75-day period ending July 20, 2009. FDA stated that the effective date of the direct final rule would be on September 17, 2009, 60 days after the end of the comment period, unless any significant adverse comment was submitted to FDA during the comment period. FDA did not receive any significant adverse comments.

Authority: Therefore, under the biological products provisions 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, 21 CFR part 601 is amended. Accordingly, the amendments issued thereby are effective.

Dated: August 14, 2009.

David Horowitz,

Assistant Commissioner for Policy.