{ "id": "R45077", "type": "CRS Report", "typeId": "REPORTS", "number": "R45077", "active": true, "source": "EveryCRSReport.com", "versions": [ { "source": "EveryCRSReport.com", "id": 577610, "date": "2018-01-12", "retrieved": "2018-05-10T11:44:09.305829", "title": "Animal Drug User Fee Programs", "summary": "The Food and Drug Administration\u2019s (FDA\u2019s) 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.\nThe 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. \nUnder both its brand-name and generic animal drug authorities, FDA may use fee revenue only for the costs of \u201cthe process for the review\u201d 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.\nAuthority 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 \u201cmust pass\u201d 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.\nAs 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 \u201cADUFA IV\u201d and \u201cADGUFA III\u201d 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.\nUnlike user fee authorities which sunset every five years, provisions in law that address FDA\u2019s 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, \u201cmust pass\u201d 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.", "type": "CRS Report", "typeId": "REPORTS", "active": true, "formats": [ { "format": "HTML", "encoding": "utf-8", "url": "http://www.crs.gov/Reports/R45077", "sha1": "a5825a761369be0293fdc1560299c249f609e0b1", "filename": "files/20180112_R45077_a5825a761369be0293fdc1560299c249f609e0b1.html", "images": { "/products/Getimages/?directory=R/html/R45077_files&id=/0.png": "files/20180112_R45077_images_708ec91db171b5106e1ed454490391644f892a7f.png" } }, { "format": "PDF", "encoding": null, "url": "http://www.crs.gov/Reports/pdf/R45077", "sha1": "ce88c712a9eb3e733096d0ac6dc85e83629b9ff7", "filename": "files/20180112_R45077_ce88c712a9eb3e733096d0ac6dc85e83629b9ff7.pdf", "images": {} } ], "topics": [] } ], "topics": [ "Appropriations", "Environmental Policy", "Health Policy" ] }