PDUFA III Five-Year Plan (July 2003)
2003 - 2004 - 2005 - 2006 - 2007
Department of Health and Human Services
FOOD AND DRUG ADMINISTRATION
Office of Management and Systems
The Prescription Drug User Fee Act (PDUFA) provides authority for FDA to collect additional resources (fees from industry) that enable FDA to accelerate its drug evaluation process without compromising review quality. The Prescription Drug User Fee Amendments of 2002 extended PDUFA through September 30, 2007 (PDUFA III). Under PDUFA III, FDA is committed to meeting demanding performance goals documented in a June 4, 2002 letter from the Secretary of Health and Human Services to the Chairmen and Ranking Minority Members of the House Committee on Energy and Commerce and the Senate Committee on Health, Education, Labor and Pensions.
In July 1998, FDA completed the first PDUFA II Five-Year Plan. It was FDA’s blueprint for investing the resources expected under PDUFA II. That plan was revised and updated periodically. Following that tradition, this initial PDUFA III Five-Year Plan similarly sets out FDA’s plans for investing the resources expected under PDUFA III, by organization component and major performance goals.
The planned fee collections and spending over the 5-year period from FY 2003 through FY 2007 total a little over $1.25 billion. This plan provides background information on PDUFA, documents the assumptions upon which the plan is based, and describes the efforts and anticipated costs to meet the performance goals associated with PDUFA III.
By spending category, 64 percent of the fee revenues will be allocated for employee salary and benefit costs, 15 percent for center and ORA operating funds, 11 percent for IT investments, 4 percent for rental payments to GSA, and 5 percent central accounts. By organization, CDER will spend 58 percent, CBER will spend 11 percent, ORA will spend 2 percent, and OC overhead will spend 8 percent, centrally funded items will use 5%, and rent payments to GSA will use 4%.
Spending at this level will not only sustain the 1088 staff years paid from fees by the end of FY 2002, but will also enable the agency to add an additional 376 staff years for the drug review process by FY 2007. Planned increases from 2002 staffing levels by component are:
- CDER-a net increase of 293 staff years by the end of 5 years
- CBER-a net increase of 59 staff years by the end of 5 years
- ORA-level staffing by the end of 5 years
- OC-a net increase of 24 staff years by the end of 5 years
Operating at these levels should enable the agency to meet PDUFA III goals through FY 2007.
Planning Process CDER Plan Summary CDER Plan Summary Tables CBER Plan Summary CBER Plan Summary Tables ORA Plan Summary ORA Plan Summary Tables OC Plan Summary OC Plan Summary Tables Information Technology, Rent and Central Accounts Information Technology, Rent and Central Account Summary Tables FDA Plan Summary FDA Plan Summary Tables Annual Reassessments Appendix A - PDUFA III Information Technology Five-Year Plan
Purpose Background - PDUFA I Background - PDUFA II Background - PDUFA III Background - PDUFA Goals Assumptions - Inflation and Inflation Adjustments Assumptions - Workload and Workload Adjustments Assumptions - Revenue Levels and Adjustments Assumptions - Anticipated Collections Assumptions - Support of PDUFA II Fee Base Levels Assumptions - All Statutory Triggers Will Be Met Assumptions - Human Resources May Be Acquired By Either Hiring Or Contracting Assumptions - Resources For The Human Drug Application Review Process Will Increase By About 16 Percent By The End Of PDUFA III Assumptions - The Resources Are Allocated To Assure That The Performance Goals Are Met Assumptions - The Plan Will Be Reassessed And Updated Annually Planning Process CDER Plan Summary CDER Plan Summary Tables CBER Plan Summary CBER Plan Summary Tables ORA Plan Summary ORA Plan Summary Tables OC Plan Summary OC Plan Summary Tables Information Technology, Rent and Central Accounts Information Technology, Rent and Central Account Summary Tables FDA Plan Summary FDA Plan Summary Tables Annual Reassessments Appendix A - PDUFA III Information Technology Five-Year Plan