Guidance for Industry: Animal Drug User Fees; Fees Exceed Costs Waiver/Reduction; Availability

Zusammenfassung

The Food and Drug Administration (FDA) is announcing the availability of the guidance for industry ( 183) entitled "Guidance for Industry: Animal Drug User Fees; Fees Exceed Costs Waiver/Reduction." This 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 (ADUFA).