Animal Drug User Fees
Proposals to reauthorize the Animal Drug User Fee Act of 2003
and authorize animal generic drug user fees

Topics on this Page

• Introduction
• What Is FDA Doing?
• News Update
• Background on ADUFA and AGDUFA

Introduction

The Food and Drug Administration has sent to Congress two proposals for user fee programs for animal drug review. One proposal calls for the reauthorization of a user fee program that FDA has successfully implemented since 2004 for review of applications for non-generic, or "pioneer," new animal drugs. This program is due to expire at the end of the current Fiscal Year (September 30, 2008). The other proposal is for a first-ever generics user fee program for generic animal drugs. Both user fee programs will facilitate more efficient development of safe and effective products available for veterinarians and animal producers, thereby improving public health.

The reauthorized user fee program for pioneer animal drugs would generate an estimated $98 million in revenue over the next 5 fiscal years. The user fee program for generic animal drugs would generate an estimated $27 million during that same time period.

Both user fee programs require FDA to meet specific performance criteria. And in both cases the user fees would be used to supplement appropriated funding for animal drug review.

What Is FDA Doing?

• FDA Recommends Two User Fee Programs to Enhance the Review Process for Animal Drugs

News Update

• FDA Proposes Recommendations for Two Animal Drug Funding Programs (April 24, 2008)

ADUFA and AGDUFA: Background

Animal Drug User Fee Amendments

• Proposed Legislation for ADUFA Reauthorization
• Section-by-Section Differences Between the Animal Drug User Fee Act of 2003 (ADUFA I) and the Animal Drug User Fee Amendments of 2008 (ADUFA II)
• Animal Drug User Fee Act Performance Goals and Procedures

Animal Generic Drug User Fee Act

• Proposed Legislation for AGDUFA
• Animal Generic Drug User Fee Act Performance Goals and Procedures