We have convened this hearing this morning to examine the animal drug and animal generic drug user fee agreements that are due to be reauthorized this year--the Animal Drug User Fee Agreement, called ADUFA, and the Animal Generic Drug User Fee Agreement, called AGDUFA. These programs mirror the fee programs for human medical products that this committee shepherded through the Senate last Congress as part of the FDA Safety and Innovation Act. Both ADUFA and AGDUFA allow FDA to collect user fees from sponsors of animal drug and animal generic drug applications, and the Agency uses those fees to help fund the review of animal drug applications. At today's hearing, we will discuss the history and purpose of these agreements between FDA and the animal drug industries that it regulates. We will delve into the agreements themselves to better understand the revenue that the fees provide and the performance standards that will benefit the industries paying those fees.

Animal drug user fee agreements : hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Thirteenth Congress, first session, on examining animal drug user fee agreements, focusing on advancing animal health for the public health, February 27, 2013.

This report discusses aspects of the Animal Drug User Fee Act of 2003 (ADUFA I), including funding and program performance; FDA's ADUFA II and Animal Generic Drug User Fee Act of 2008 (AGDUFA) proposals; congressional activity; and other relevant issues.