The Federal Food, Drug, and Cosmetic Act, as amended by ADUFA, authorizes FDA to collect fees from the animal pharmaceutical industry to augment appropriations spent on FDA’s animal drug review process. FDA spends the fee revenues to hire, support, and maintain personnel for the review of animal drug applications to ensure safe and effective drug products reach the American public more quickly.
The Animal Drug User Fee Amendments of 2008 (Title I of the 2008 amendments made to the Federal Food, Drug, and Cosmetic Act) amended ADUFA and extended its authorization for an additional 5 years, through 2013. The reauthorization is referred to as ADUFA II.
Under ADUFA II, approximately one fourth of the revenues continue to be derived from each of four types of fees: (1) fees on certain animal drug applications and supplemental animal drug applications (for which safety or effectiveness data are required); (2) annual fees for certain animal drug products; (3) annual fees for certain establishments that manufacture animal drug products; and (4) annual fees paid by certain animal drug sponsors. The aggregate fee revenue amount, and amounts for each type of fee, are set in statute, with provisions for adjustment. ADUFA II authorizes FDA to set fees for each fiscal year so that the total revenue FDA receives in each category is estimated to equal the statutory amount, after adjustment for workload. FY 2009 is the sixth year of the ADUFA program. FDA set fees for FY 2009 in accordance with the amounts specified in ADUFA II (see 73 FR 53254). Inflation adjustments were built into the statutory fee revenue totals for each of the 5 years of ADUFA II, so no additional changes are necessary. Additionally, adjustments to the statutory fee revenue totals for workload will begin after FY 2009, according to the workload adjustment provision in ADUFA II.
ADUFA requires FDA to submit two reports to Congress in each fiscal year: 1) a performance report sent within 60 days of the end of the fiscal year, and 2) a financial report sent within 120 days of the end of the fiscal year. The FY 2009 ADUFA Performance Report, that describes FDA’s progress in meeting the goals referred to in ADUFA, is being transmitted separately to Congress. This report is the FY 2009 ADUFA Financial Report that addresses the implementation and use of animal drug user fees by FDA during the period of October 1, 2008 through September 30, 2009.
As required by ADUFA, this report also discusses the legal conditions that FDA must satisfy before it can collect and spend the animal drug user fees each year. In addition, this report presents summary statements of FY 2009 fee collections, carryover cash balances, obligations from fees, and total costs of the process for the review of animal drug applications from both fees and appropriations.