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. Animal drug user fee authority sunsets October 1, 2008. If the program were not reauthorized by then, FDA would have been prohibited at that time from collecting user fees, and would have to lay off animal drug review staff. On July 8, 2008, bills were introduced in the House to reauthorize ADUFA ( H.R. Both bills were forwarded without amendment to the full committee by the House Energy and Commerce Subcommittee on Health the following day, and were marked up by the full committee on July 16, 2008. 6432 , as amended, under suspension. The engrossed bill incorporated an amended version of H.R. On August 1, 2008, the Senate took up the House-passed measure and passed it by unanimous consent. Reauthorization of the existing user fee program was supported by animal drug research and development companies, livestock producers, and the American Veterinary Medical Association. Because a sunset of program authority would have been highly disruptive to the animal drug review process, many supporters felt that ADUFA reauthorization was "must pass" legislation in the 110 th Congress. A coalition of consumer groups opposed the user fee program and its reauthorization, however, citing concerns about the safety of animal drugs approved for livestock production. This report discusses aspects of ADUFA I, including funding and program performance; FDA's proposed changes for ADUFA II; FDA's proposal for a new generic animal drug user fee program; congressional activity; and relevant issues. Appendix A provides a summary of ADUFA I. Appendix B describes the FDA process for approval of animal drugs. This report will be updated to incorporate legislative actions and other events as they unfold. Overview of ADUFA I

		Legislative History

The Animal Drug User Fee Act of 2003 (ADUFA I, P.L. The bills that were ultimately enacted in the 108 th Congress were H.R. FDA Proposal for Generic Animal Drug User Fees

Though ADUFA I required FDA to take steps to ensure that the user fee program did not compromise the timeliness of generic animal drug reviews, FDA has had difficulty keeping up with these reviews, and has not generally met the statutory requirement to act on ANADAs within 180 days. Both bills were forwarded without amendment to the full committee by the House Energy and Commerce Subcommittee on Health on July 9, and marked up and passed by the full committee on July 16. 6432 (ADUFA reauthorization) as reported, and H.R. 6433 (AGDUFA), as reported. 6433 , the Animal Generic Drug User Fee Act of 2008, as introduced, would establish a new animal generic drug user fee program, largely in line with FDA's proposal. On July 30, 2008, the House passed an amended version of H.R. The measure has been sent to the President, who is expected to sign it.
The Animal Drug User Fee Act of 2003 (ADUFA I, P.L. 108-130) gave the Food and Drug Administration (FDA) initial authority to collect user fees from sponsors for the review of animal drug applications. ADUFA mirrors fee programs for human drugs and medical devices. Program authority sunsets October 1, 2008, and FDA would have to lay off staff in its review program if the program were not reauthorized by then. ADUFA supporters—including companies that make brand-name animal drugs, and livestock producer groups—considered ADUFA reauthorization to be "must pass" legislation in the 110th Congress. A coalition of consumer groups opposed the program and its reauthorization, citing, in particular, concerns about the safety of animal drugs used in livestock production.
After negotiations with brand-name animal drug companies, FDA made several proposals for the reauthorization of ADUFA (ADUFA II), including a near-doubling of the total amount of fees to be collected in the future. The proposed increase would support continued enhancements of FDA's review program, further improvements in the timeliness of reviews, and the elimination of a backlog of pre-approval inspections of foreign manufacturing facilities. FDA presented draft reauthorizing legislation to Congress in April 2008. H.R. 6432, the Animal Drug User Fee Amendments of 2008, a bill to reauthorize the program, was introduced on July 8, 2008. Subsequently, the bill was forwarded without amendment to the full committee by the House Energy and Commerce Subcommittee on Health, and was marked up by the full committee on July 16, 2008.
ADUFA does not cover generic animal drugs. FDA has not been able to maintain the statutory requirement for timeliness of generic animal drug reviews since ADUFA was enacted. FDA presented a draft Animal Generic Drug User Fee Act (AGDUFA) to Congress in April 2008, separate from the ADUFA II draft bill. H.R. 6433, the Animal Generic Drug User Fee Act of 2008, was introduced on July 8, 2008. Subsequently, the bill was forwarded without amendment to the full committee by the House Energy and Commerce Subcommittee on Health, and was marked up by the full committee on July 16, 2008.
On July 30, 2008, the House passed H.R. 6432, as amended, under suspension. The engrossed (House-passed) bill incorporated an amended version of H.R. 6432 (ADUFA reauthorization), as reported, and H.R. 6433 (AGDUFA), as reported, without amendment. On August 1, 2008, the Senate took up the House-passed measure and passed it by unanimous consent. The measure has been sent to the President, who is expected to sign it.
This report discusses aspects of ADUFA I, including funding and program performance; FDA's ADUFA II and AGDUFA proposals; congressional activity; and relevant issues. Appendix A provides a summary of ADUFA I. Appendix B describes the FDA process for approval of animal drugs. This report will be updated to incorporate legislative actions and other events as they unfold.