About FDA
FY 2007 ADUFA Financial Report
required by the
ANIMAL DRUG USER FEE ACT OF 2003
Food and Drug Administration
Department of Health and Human Services
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Table of Contents
Main Report
Letter from the Secretary of Health and Human Services
Meeting the Legal Conditions for User Fees in FY 2007
Obligation of User Fee Collections
Total Cost of the Process for this Review of Animal Drug Applications
Appendices
Appendix A: Conditions for Assessment and Use of Fees
Appendix B: Number of Applications Paid By Fees in FY 2007
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
Letter to the Secretary Department of Health and Human Services
October 16, 2008
The Honorable Richard Cheney
President of the Senate
United States Senate
Washington, D.C. 20510
Dear Mr. President:
Enclosed for your consideration is the fourth annual financial report to Congress required by the Animal Drug User Fee Act (ADUFA) of 2003. This report covers fiscal year (FY) 2007, documenting how each of the legal conditions specified in the 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 2007, 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 2007, FDA had net collections of $13.5 million and spent $12.3 million in animal drug user fees. Approximately 54 percent of the fees were spent on personnel compensation and benefits for staff. The remaining 46 percent was spent for other operational expenses including support and infrastructure for the animal drug review process.
The funds provided by the ADUFA are crucial to ensuring FDA has qualified personnel and the appropriate infrastructure to review new animal drugs in a timely manner.
Sincerely,
Michael O. Leavitt
Enclosure
Identical letters to:
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Executive Summary
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 fourth financial report that covers activities for fiscal year (FY) 2007.
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.
This report explains how FDA met the three legal conditions in FY 2007. The statements and tables in the report provide data on animal drug fee collections and expenditures for the animal drug review process in FY 2007. In FY 2007, FDA collected $13.5 million in animal drug user fees, spent $12.3 million in user fees for the review process, and carried a cash balance of $6.1 million forward for future fiscal years.
ADUFA implementation strategies facilitated the recruitment of 18 new review staff in FY 2007. The animal drug user fees spent in FY 2007 supported 55 full-time equivalent staff years and in addition, other operational expenses such as computers, furniture, supplies, rent, and other infrastructure needs. In FY 2008, 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 2008.
