PDUFA IV 5-Year Financial Plan (2008): Planning Process
The planning process for meeting new PDUFA IV goals began during discussions with stakeholders in the last year of PDUFA III. The ability to continue to meet PDUFA III goals was contingent on receiving enough resources to maintain the PDUFA III fee base plus the resources described in Assumption 5, PDUFA IV Fee Base. As new goals were proposed, resource implications were also estimated and discussed. These ongoing discussions over many months resulted in the PDUFA IV goals sent to Congress on March 16, 2007. The PDUFA IV resource levels and adjusters to achieve these goals were enacted in the PDUFA IV statute.
This PDUFA IV Five-Year Financial Plan is patterned after the five-year plan for PDUFA III. The plan reflects the resources anticipated and FDA plans for investing those resources. The plan is intended to be a dynamic document, and will be updated if necessary for significant changes in circumstances.
In developing this plan, the Office of Management (OM) worked with the Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), and the Office of Regulatory Affairs (ORA) to integrate their plans into an overall FDA plan. The primary focus of this effort was to ensure sound plans supporting PDUFA IV goals. CDER, CBER and ORA were each asked to reassess essential needs in order to ensure that they meet the PDUFA IV goals.
The complete PDUFA IV Information Technology (IT) Five-Year Plan has been developed and made available separately.
The overall PDUFA IV Five-Year Financial Plan resulting from this process provides a sound blueprint for the investments needed to ensure FDA success with PDUFA IV. The following pages summarize the planned distribution of PDUFA IV funds to each component (CDER, CBER, and ORA, and OC) over the five years of the plan and a summary section on IT, Rent and Central Accounts. At the end there are FDA Plan Summary Tables. The two largest demands continue to be: (1) additional human resources to meet the PDUFA IV goals and (2) IT investments both to enhance paperless application receipt and review and to consolidate IT resources to assure their efficient use.