U.S. Food and Drug Administration

Animal Drug User Fee Act

The Act

On August 14, 2008, President Bush signed the Animal Drug User Fee Amendments of 2008 (ADUFA).  ADUFA was originally passed in 2003 and was set to expire on September 30, 2008. The new amendments extend ADUFA until 2013.  ADUFA amends the Food, Drug and Cosmetic Act to authorize FDA to collect fees to enhance the performance of the new animal drug review process and ensure that new animal drug products are safe and effective for animals as well as for the public with respect to animals intended for food consumption.

This program is similar to the very successful programs for human drugs and medical devices, the Prescription Drug User Fee Act and the Medical Device User Fee and Modernization Act.

>>More on ADUFA


Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2009 (Federal Register,Sept. 15, 2008)
PDF (59 KB)

Fee rate notices from previous years


User Fee Cover Sheet


Guidance for Industry #173: Animal Drug Sponsor Fees under the Animal Drug User Fee Act (ADUFA) (60 KB PDF)

Guidance for Industry #170: Animal Drug User Fees and Fee Waivers and Reductions
PDF (96.5 KB)

Guidance for Industry #183: Animal Drug User Fees: Fees Exceed Costs Waiver/Reduction (161 KB PDF)


FY 2007 Performance Report
PDF (205 KB)

FY 2007 Financial Report
PDF (307 KB)

Reports archive

More ADUFA Information

Other User Fee Information


Email general questions to cvmadufa@fda.hhs.gov

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