AGDUFA, Public Law 110-316, authorizes FDA to collect fees for certain abbreviated applications for generic new animal drugs, on certain generic new animal drug products, and on certain sponsors of such abbreviated applications for generic new animal drugs and/or investigational submissions for generic new animal drugs.
AGDUFA was patterned in part after the Animal Drug User Fee Act (ADUFA). Under AGDUFA, three different kinds of user fees are established: (1) fees for certain types of abbreviated applications for generic new animal drugs (approximately 30 percent of estimated revenue); (2) annual fees for certain generic new animal drug products (approximately 35 percent of estimated revenue); and (3) annual fees for sponsors of generic animal drug applications and/or investigational submissions for a generic new animal drug (approximately 35 percent of estimated revenue). The aggregate fee revenue amount and amounts for each type of fee are set in statute, with provisions for adjustment. AGDUFA authorizes FDA to set fees for each fiscal year so that the total revenue FDA plans to receive in each category is estimated to equal the statutory amount, after adjustment for workload, if required.
AGDUFA requires FDA to submit two reports to Congress each fiscal year: 1) a performance report to be sent within 60 days of the end of the fiscal year, and 2) a financial report to be sent within 120 days of the end of the fiscal year. The FY 2010 AGDUFA Performance Report, that describes FDA’s progress in meeting the goals referred to in AGDUFA, is being transmitted separately to Congress. This report is the FY 2010 AGDUFA Financial Report that addresses the implementation and use of animal generic drug user fees by FDA during the period of October 1, 2009 through September 30, 2010.
As required by AGDUFA, this report discusses the legal conditions that FDA must satisfy before it can collect and spend the animal generic drug user fees each year. In addition, this report presents summary statements of FY 2010 fee collections, carryover cash balances, obligations from fees, and total costs of the process for the review of animal generic drug applications from both fees and appropriations.