	Background

		Introduction

The Federal Food, Drug, and Cosmetic Act (FFDCA) authorizes the Food and Drug Administration (FDA) to regulate the safety and effectiveness of animal drugs. FDA's review of brand-name and generic a nimal drug applications is funded through a combination of annual discretionary appropriations from Congress and user fees collected from the regulated industry. Authority to collect user fees for brand-name (pioneer) animal drugs has been written to sunset at five-year intervals, and was reauthorized in 2008 and 2013 in laws referred to as ADUFA II and ADUFA III, respectively. Congress first authorized FDA's collection of user fees for generic animal drugs for FY2009 in the Animal Generic Drug User Fee Act of 2008 (AGDUFA I, P.L. 110-316 ), coincident with ADUFA II. Under both its brand-name and generic animal drug authorities, FDA shall use fee revenue for the costs of "the process for the review" of the respective animal drug type, which includes the following: review of applications and other submissions; facility inspections; oversight of research to support the application/submission; issuance of regulations, policies, standards, and action letters; and review of labeling and advertising prior to approval. Neither authority permits postmarket review activities under current law. As a result, user fee reauthorizations are often considered "must pass," and Congress has consistently reauthorized ADUFA and AGDUFA before their sunset dates. 2. 100-670 ) created an expedited pathway for the review of generic animal drugs. Authorities that address FDA's regulation of animal drugs used in food-producing animals are generally permanent. They are not part of the statutory language in FFDCA Title VII that authorizes user fees and is subject to sunset. However, ADUFA /AGDUFA reauthorization offers a rare legislative focus on animal drug issues, and amendments dealing with these and other aspects of animal drug use are often considered by Congress during the reauthorization process. Animal Drug User Fee Programs

		Brand-Name (Pioneer) Animal Drugs and ADUFA

Congress first authorized user fees for brand-name animal drug review in 2003 in response to the same concerns from animal drug sponsors that had spurred establishment of a user fee program for human drugs a decade earlier. Minutes of all negotiation meetings between FDA and industry must be posted on the FDA website. According to the agency's section by section summary of the proposed statutory changes, the proposed ADUFA IV, in addition to codifying several of the proposals in the draft agreement, would amend (1) the definition of "animal drug application" to include an application for conditional approval under FFDCA Section 571, and (2) the definition of "process for the review of animal drug applications" to include certain activities related to implementation of the US-European Union GMP Mutual Inspection Agreement. In exchange for the authority to collect user fees, AGDUFA requires FDA to pursue certain performance goals negotiated between the agency and industry. Reauthorization

FFDCA Section 742(d), as amended by AGDUFA II, sets forth the process for reauthorization of AGDUFA II, directing FDA to develop recommendations for the following five fiscal years in consultation with specified congressional committees, scientific and academic experts, veterinary professionals, patient and consumer advocacy groups, and the regulated industry.
The Food and Drug Administration's (FDA's) review of brand-name and generic animal drug applications is funded through a combination of annual discretionary appropriations from Congress and user fees collected from the regulated industry.
The Animal Drug User Fee Act of 2003 (ADUFA I, P.L. 108-130) gave FDA initial authority to collect user fees from sponsors to improve the timeliness of review of animal drug applications. ADUFA I did not cover generic animal drugs. In 2008, in response to concerns regarding generic drug application review times and a backlog of applications, Congress passed legislation that reauthorized ADUFA and created a new user fee program for generic animal drugs. Title II of P.L. 110-316, the Animal Generic Drug User Fee Act (AGDUFA I), provided FDA with authority to collect user fees for the review of generic animal drug applications.
Under both its brand-name and generic animal drug authorities, FDA may use fee revenue only for the costs of "the process for the review" of the respective animal drug type, which includes the following: review of applications and other submissions; facility inspections; oversight of research to support the application/submission; issuance of regulations, policies, standards, and action letters; and review of labeling and advertising prior to approval. Neither authority permits postmarket review activities under current law.
Authority to collect user fees for animal drug review has been written to sunset at five-year intervals; as a result, reauthorization is often considered to be "must pass" legislation. Congress last reauthorized ADUFA and AGDUFA through September 30, 2018, via the Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013 (P.L. 113-14). ADUFA and AGDUFA reauthorization consists of two parts: (1) statutory language that reauthorizes the programs, and (2) the negotiated agreement on performance goals and procedures between FDA and industry for the upcoming five-year interval. FDA is tasked by law with specific responsibilities in the reauthorization process.
As required for the upcoming reauthorization, in May 2016 FDA held two public meetings, one each for ADUFA and AGDUFA, to begin the process. For the next several months through early 2017, FDA held separate negotiations with the brand-name and generic animal drug industries, and met with other stakeholder groups (scientific and academic experts, veterinary professionals, patient and consumer advocacy groups). On October 25, 2017, FDA published in the Federal Register the "ADUFA IV" and "ADGUFA III" reauthorization proposals, including commitments negotiated with industry. On November 2, 2017, the agency held two public meetings, one each for ADUFA and AGDUFA, to discuss the proposed recommendations and commitments. Pursuant to the statute, these recommendations must be submitted to Congress by January 15, 2018.
Unlike user fee authorities which sunset every five years, provisions in law that address FDA's regulation of animal drugs are typically permanent. They are not part of the statutory language that authorizes user fees, and they are not subject to sunset. However, ADUFA /AGDUFA reauthorization offers a rare, "must pass" legislative focus on animal drug issues. Amendments dealing with other animal drug issues of interest to Congress, such as the use of antimicrobial drugs in food-producing animals, are often considered during the reauthorization process.