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.

It established a new requirement, effective in FY2004, for FDA to collect fees from sponsors of brand-name animal drugs in order to reduce the backlog of reviews for those products, decrease the time required for future reviews, and improve the predictability of the review process. [...] Overview of ADUFA I Legislative History The Animal Drug User Fee Act of 2003 (ADUFA I, P. L. 108-130) established, for the first time, effective in FY2004, authority for FDA to collect fees from sponsors of animal drugs in order to reduce the backlog of application reviews for those products, and to decrease the time required for future reviews. [...] The law requires the Secretary, to the extent practicable, to segregate the review of ANADAs from that of NADAs, and adopt other administrative procedures to ensure that review times of ANADAs do not increase because of activities under the user fee program. [...] The act required the Secretary to set annual fees at least 60 days before the start of each fiscal year and to publish the fees and methodology in the Federal Register. [...] The goals were not incorporated in the statute, which instead refers to the goals as identified in the Secretary's letter to the chairmen and ranking members of the House 15 ADUFA fee information is available at [ ].

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.