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U.S. Department of Health and Human Services

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PDUFA IV Five-Year Financial Plan - 2009 Update (September 2009)

FDA and HHS Logo

Five-Year Financial Plan-
2009 Update

2008 - 2009 - 2010 - 2011 - 2012


Department of Health and Human Services
Office of Administration
Office of Financial Operations

Update-September 2009


Executive Summary

The Prescription Drug User Fee Act (PDUFA) provides authority for the Food and Drug Administration (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 2007 extended PDUFA through September 30, 2012 (PDUFA IV). Under PDUFA IV, FDA is committed to meeting the demanding performance goals documented in a September 7, 2007 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. In July 2003, FDA completed the PDUFA III Five Year Plan. In September 2008 FDA completed the PDUFA IV Five-Year Financial Plan similarly sets out FDA's plans for investing the resources expected under PDUFA IV, by organization component and areas of PDUFA IV program increase. This FY 2009 Update to that plan revises the revenue FDA assumes that it will collect over the 5 years due to the workload adjustment in PDUFA IV. That change (Assumption 2 on page 7) causes an upward adjustment of planned revenue of about $130 million over the 5 years of the plan.

The planned fee collections and spending over the 5-year period from fiscal year (FY) 2008 through FY 2012 increase to a total of over $2.88 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 IV.

By spending category, 60 percent of the fee revenues will be allocated for employee salary and benefit costs, 18 percent for operating expenses to support the staff, 8 percent for IT investments, 7 percent for rental payments to GSA and rent related costs, and 7 percent central accounts.

Spending at this level will sustain 1989 full time equivalent (FTE) staff years paid from fees in FY 2008. This is an increase of 472 more FTE paid from fees in FY 2008 than in FY 2007 - 290 FTE to sustain 2007 performance levels, plus 183 FTE for program enhancements. In addition, the agency will be able to add another 330 FTE by FY 2012. Planned increases over FY 2007 FTE levels, by component, are:

  • CDER – a net increase of 381 staff years in 2008 and of 720 at the end of 5 years
  • CBER – a net increase of 67 staff years in 2008 and of 127 at the end of 5 years
  • ORA – a net increase of 1 staff year in 2008 and through the end of 5 years
  • OC – a net increase of 23 staff years in 2008 and of 52 by the end of 5 years

Operating at these levels should enable the agency to meet PDUFA IV goals through FY 2012.