Background: FY 2011 ADUFA Financial Report
The Federal Food, Drug, and Cosmetic Act (FD&C 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 fee revenues and appropriations to hire, support, and maintain personnel for the review of animal drug applications to ensure safe and effective animal drug products reach the American public more quickly.
The Animal Drug User Fee Amendments of 2008 (Public Law 110-316) amended ADUFA and extended its authorization for an additional five 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 amounts, 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 plans to receive in each category is estimated to equal the statutory amount, after adjustment for workload. However, the workload adjustment cannot result in fee revenues for a fiscal year that are less than the fee revenues for that fiscal year as specified in the statute.
In August 2010, FDA set fees for FY 2011 in accordance with the amounts specified in ADUFA II (see 73 FR 53254). Because applying the workload adjustment factor for FY 2011 as calculated by FDA would have resulted in fee revenues lower than the statutory amount, FDA used the statutory revenue amounts for each category of fees in determining its fee revenue target for FY 2011. In addition, because inflation adjustments were built into the statutory fee revenue totals for each of the five years of ADUFA II, no additional adjustments to the statutory fee revenue amounts for inflation were necessary.
ADUFA requires FDA to submit two reports to Congress each fiscal year:
1) a performance report to be submitted within 60 days after the end of the fiscal year; and
2) a financial report to be submitted within 120 days after the end of the fiscal year.
The FY 2011 ADUFA Performance Report, which describes FDA’s progress in meeting the goals referred to in ADUFA, is being transmitted separately to Congress. This report is the FY 2011 ADUFA Financial Report that addresses the implementation and use of animal drug user fees by FDA during the period of October 1, 2010, through September 30, 2011.
As required by ADUFA, this report discusses the legal conditions that must be satisfied for FDA to collect and spend animal drug user fees each year. In addition, this report also presents statements of FY 2011 fee collections, cash carryover balances, obligations of user fees, and total costs of the process for the review of animal drug applications paid from user fees and appropriations.