Draft Guidance for Industry; Animal Drug User Fees: Fees Exceed Costs Waivers and Reductions; Availability

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance for industry ( 183) entitled "Animal Drug User Fees: Fees Exceed Costs Waivers and Reductions." The draft guidance explains the procedures FDA expects to use to evaluate waiver requests under the fees exceed costs waiver provision of the Animal Drug User Fee Act of 2003.