Animal Drug User Fee Cover Sheet

The cover sheet (Form FDA 3546) is designed to collect the minimum necessary information to determine whether a fee is required for the review of an application or supplement or whether an application fee waiver was granted, to determine the amount of the fee required, and to assure that each animal drug user fee payment is appropriately linked to the animal drug application for which payment is made. The form, when completed electronically, will result in the generation of a unique payment identification number used by FDA to track the payment. FDA’s Center for Veterinary Medicine and FDA’s Office of Financial Management will use the information collected to initiate the administrative screening of new animal drug applications and supplements to determine whether payment has been received.

The latest form for Animal Drug User Fee Cover Sheet expires 2020-08-31 and can be found here.