The planning process for meeting new PDUFA III goals began during discussions with stakeholders in the last year of PDUFA II. The ability to continue to meet PDUFA II goals was contingent on getting enough resources to maintain the PDUFA II additive base and the resources needed to enhance training and staffing. As new goals were proposed, resource implications were also estimated and discussed. These ongoing discussions over many months resulted in the PDUFA III goal letters of June 4, 2002. The PDUFA III resource levels and adjusters to achieve these goals were enacted in the PDUFA III statute.
This PDUFA III Five-Year Plan is patterned after the five-year plan for PDUFA II and its annual updates. The plan reflects the resources anticipated and FDA plans for investing those resources. The plan is intended to be a living and dynamic document, and will be updated annually.
In developing this plan, the Office of Management and Systems (OMS) worked with CDER, CBER, and ORA to integrate their plans into an overall FDA plan. The primary focus of this effort was to ensure sound plans supporting PDUFA III goals. CDER, CBER and ORA were each asked to reassess essential needs in order to ensure that they meet the PDUFA III goals.
The complete PDUFA III Information Technology (IT) Five-Year Plan is included in this plan (Appendix A). It is summarized in the following pages as a single overall plan for FDA, rather than in the narratives and estimates of each component, as was the case in the PDUFA II IT plans.
The overall PDUFA III Five-Year Plan resulting from this process provides a sound blueprint for the investments needed to ensure FDA success with PDUFA III. The following pages summarize the planned distribution of PDUFA III 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 III goals and (2) IT investments both to enhance paperless application receipt and review and to consolidate IT resources to assure their efficient use.