[Federal Register Volume 74, Number 161 (Friday, August 21, 2009)]
[Rules and Regulations]
[Page 42175]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-20119]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 601

[Docket No. FDA-2009-N-0100]


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.

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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.
[FR Doc. E9-20119 Filed 8-20-09; 8:45 am]
BILLING CODE 4160-01-S