For Industry

PDUFA IV Five Year Financial Plan Report (September 2008)

PDUFA IV

Five-Year Financial Plan

Fiscal Years

2008 - 2009 - 2010 - 2011 - 2012

Department of Health and Human Services

FOOD AND DRUG ADMINISTRATION

Office of Operations

Office of Management

September 2008

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. Following that tradition, this PDUFA IV Five-Year 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.

The planned fee collections and spending over the 5-year period from fiscal year (FY) 2008 through FY 2012 total a little over $2.75 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. By organization, CDER will spend 59 percent, CBER will spend 10 percent, ORA will spend 1 percent, OC overhead will account for 8 percent, centrally funded items will account for 7 percent, and rent payments to GSA and rent related expenses will account for 7 percent, and IT will account for 8 percent.

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 190 FTE by FY 2012. Planned increases over FY 2007 FTE levels, by component, are: