FDA considering changes to ADUFA

Rockville, MD. - 2/22/08 - The Food and Drug Administration (FDA) is considering the implementation of an Animal Drug User Fee Act (ADUFA) Reauthorization plan that focuses on the drug review program's funding, application process and technology.

Enacted in 2003, ADUFA authorizes FDA to collect user fees from the animal health industry, funds which are then applied to the approval process, making it faster and more predictable.

Intending to improve ADUFA performance, the proposed recommendations aim to ensure financial footing for the Animal Drug Review Program; enhance the process for Review of Animal Drug Applications; and improve the Information Technology Infrastructure for Animal Drug Review.

The recommendations, which would be applied for fiscal years 2009 through 2013 if approved, will be reviewed during an open meeting March 11 where the public will be encouraged to share their opinions on the plan. Written comments may also be submitted until April 14, 2008.

The public meeting notice and request for comments announcement by the Federal Register is available here .