Document ID: FDA-2009-N-0436-0003
Agency: fda
Document Type: Rule
Title: Confirmation of Effective Date: New Animal Drug Applications
Posted Date: 2010-03-08T05:00Z

[Federal Register Volume 75, Number 44 (Monday, March 8, 2010)]
[Rules and Regulations]
[Page 10413]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-4923]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 514

[Docket No. FDA-2009-N-0436]

New Animal Drug Applications; 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 8, 2010, for the final rule that appeared in 
the Federal Register of October 23, 2009 (74 FR 54749). The direct 
final rule amends the regulations regarding new animal drug 
applications (NADAs). Specifically, this direct final rule is being 
issued to provide that NADAs shall be submitted in the described form, 
as appropriate for the particular submission. Currently, the regulation 
requires that all NADAs contain the same informational sections and 
does not explicitly provide the appropriate flexibility needed to 
address the development of all types of new animal drug products. This 
amendment will allow the agency to appropriately review safety and 
effectiveness data submitted to support the approval of new animal drug 
products. This document confirms the effective date of the direct final 
rule.

DATES: Effective date confirmed: March 8, 2010.

FOR FURTHER INFORMATION CONTACT:  Urvi Desai, Center for Veterinary 
Medicine (HFV-100), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-276-8297, e-mail: urvi.desai@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In the Federal Register of October 23, 2009 
(74 FR 54749), FDA solicited comments concerning the direct final rule 
for a 75-day period ending January 6, 2010. FDA stated that the 
effective date of the direct final rule would be on March 8, 2010, 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 Federal Food, Drug, and Cosmetic 
Act and under authority delegated to the Commissioner of Food and 
Drugs, 21 CFR part 514 is amended. Accordingly, the amendments 
issued thereby are effective.

    Dated: March 3, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-4923 Filed 3-5-10; 8:45 am]
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