[Federal Register Volume 75, Number 44 (Monday, March 8, 2010)]
[Rules and Regulations]
[Page 10413]
From the Federal Register Online via the Government Publishing 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: [email protected].
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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