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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

 

This Report is available in printer-friendly PDF format 302 KB)

Note: Documents in PDF format require the Adobe Acrobat Reader®. If you experience problems with PDF documents, please download the latest version of the Reader®.

 


 

Table of Contents

 

Main Report

Letter from the Secretary of Health and Human Services

Executive Summary

Background

Meeting the Legal Conditions for User Fees in FY 2007

User Fee Collections

Obligation of User Fee Collections

Carryover Balances

Total Cost of the Process for this Review of Animal Drug Applications

Management Plans for FY 2008

Footnote

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

Footnote

 


 

Letter to the Secretary Department of Health and Human Services

HHS Letterhead 

 


 

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:

  • Speaker of the House of Representatives
  • Chairman and Ranking Minority Member, Committee on Health, Education, Labor, and Pensions, United States Senate
  • Chairman and Ranking Minority Member, Committee on Energy and Commerce, House of Representatives

 


 

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:

  1. 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.
  2. Fee collections must be specified in Appropriation Acts.
  3. 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.