FY 2006 ADUFA Financial Report
required by the
ANIMAL DRUG USER FEE ACT OF 2003
Food and Drug Administration
Department of Health and Human Services
Table of Contents
Appendix A: Conditions for Assessment and Use of Fees
Appendix B: Number of Application Paid by Fees in FY 2006
Appendix C: Waivers and Reductions Granted
Appendix D: Allowable and Excluded Costs for the Process for the Review of Animal Drug Applications
Appendix E: Development of Costs for the Process for the Review of Animal Drug Applications
September 13, 2007
The Honorable Richard Cheney
President of the Senate
United States Senate
Washington, D.C. 20510
Dear Mr. President:
Enclosed for your consideration is the third annual financial report to Congress required by the Animal Drug User Fee Act of 2003 (ADUFA). This report covers fiscal year (FY) 2006, documenting how each of the legal conditions specified in ADUFA allowing the Food and Drug Administration (FDA) to continue collecting and spending the animal drug user fees was met.
In addition, this report presents the user fee collections and related expenses for FY 2006, and details the amounts carried forward at the end of the year that remain available to enhance the process for the review of new animal drug applications and submissions. In FY 2006, FDA had net collections of $11 million and spent $9.7 million in animal drug user fees. Approximately 70 percent of the fees were spent on personnel compensation and benefits for staff. The remaining 30 percent was spent for other operational expenses including support and infrastructure for the animal drug review process. The infusion of human capital resources possessing the right scientific and technical competencies with appropriate infrastructure and support is critical to enabling FDA to meet the performance goals associated with ADUFA — goals that become increasingly more stringent each year.
We are pleased that Congress enacted ADUFA, which will provide increasing levels of user fees through FY 2008. The additional funding will enable FDA to substantially strengthen its animal drug review process, and continue to ensure new safe and effective animal drugs are available to the public in a timely manner.
Michael O. Leavitt
Identical letters to:
The Animal Drug User Fee Act of 2003 (ADUFA) requires the Food and Drug Administration (FDA) to report annually on the financial aspects of its implementation of the Act. Required under ADUFA, this is the third financial report that covers activities for fiscal year (FY) 2006.
ADUFA (Public Law 108-130) was signed into law by the President on November 18, 2003. It authorizes FDA to collect fees for certain applications and supplements, establishments, products, and sponsors in support of the review of new animal drugs. On November 10, 2005, the President signed appropriations legislation for FY 2006 (Public Law 109-97), which included animal drug user fees for FDA. This action enabled FDA to begin to collect and spend the authorized FY 2006 animal drug user fees.
ADUFA specifies that the following three legal conditions must be satisfied each fiscal year in order for FDA to collect and spend ADUFA user fees:
- FDA’s overall salaries and expenses appropriation, excluding fees, must exceed FDA’s overall FY 2003 salaries and expenses appropriation, excluding fees and adjusted for inflation.
- Fee collections must be specified in Appropriation Acts.
- FDA must spend at least as much from appropriated funds for the review of animal drug applications as it spent in FY 2003, adjusted for inflation.
The report explains how FDA met the three legal conditions in FY 2006. The statements and tables in the report provide data on animal drug fee collections and expenditures for the animal drug review process in FY 2006. In FY 2006, FDA collected $11 million in animal drug user fees, spent $9.7 million user fees for the review process, and carried a cash balance of $4.9 million forward for future fiscal years.
ADUFA implementation strategies facilitated the recruitment of 17 new review staff in FY 2006. The animal drug user fees spent in FY 2006 supported 58 full-time equivalent staff years and in addition, other operational expenses such as computers, furniture, supplies, rent, and other infrastructure needs. In FY 2007, FDA will spend user fees to continue enhancing the review program and recruit the additional review staff necessary to meet the challenging performance goals associated with this program in FY 2007 and beyond.