New Animal Drug Applications; Confirmation of Effective Date

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.