2010-4923. New Animal Drug Applications; 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 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: [e-mail].

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.