March 11, 2013
The U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM) has completed its recommendations for the reauthorization of the Animal Drug User Fee Act (ADUFA) and the Animal Generic Drug User Fee Act (AGDUFA). The proposals for reauthorization outline the performance goals and procedures for each program for fiscal years 2014 through 2018.
Health and Human Services Secretary Kathleen Sebelius transmitted the recommendations to Congress on Feb. 25, 2013. On Feb. 27, 2013, CVM Director Bernadette Dunham testified on the recommendations and FDA’s performance record under ADUFA and AGDUFA before the U.S. Senate Committee on Health, Education, Labor and Pensions, receiving an overwhelmingly positive response from the committee members in attendance.
These two programs authorize FDA to collect fees to enhance the animal drug review process and the generic new drug review process to ensure that new animal drug products are safe and effective for animals, and for humans with respect to animals intended for food consumption.
Congress first approved the user fee program for animal drugs under the Animal Drug User Fee Act (ADUFA) of 2003, and the program for generic new animal drugs under the Animal Generic Drug User Fee Act of 2008. Both programs must be reauthorized every five years.
The authority for these programs expires on October 1, 2013 unless reauthorized by Congress. FDA’s recommendations for ADUFA III and AGDUFA II were developed in consultation both with drug industry representatives and with veterinary medicine stakeholders.
ADUFA Reauthorization - Performance Goals and Procedures - Fiscal Years 2014 through 2018(PDF - 123KB) Proposed ADUFA III Provisions of the Federal Food, Drug, and Cosmetic Act(PDF - 204KB) AGDUFA Reauthorization - Performance Goals and Procedures - Fiscal Years 2014 through 2018(PDF - 87KB) Proposed AGDUFA II Provisions of the Federal Food, Drug, and Cosmetic Act(PDF - 90KB)