This plan will be revised each year based on the latest information available. This information facilitates the resource allocation and planning for center work required to meet the PDUFA III goals. Actual workload and revenues will continue to be monitored closely.
The plan is a dynamic framework for the investments FDA must make. It will be updated again in the second quarter of FY 2004. That update will take into account the actual accomplishments, workload, revenues, and expenses of the previous fiscal years and the planned accomplishments, workload, revenues and fees to be charged over the remaining period of PDUFA III. Workload and revenue estimates are always based on the information set forth in the latest Federal Register notice setting fees, published in August of each year.
If reassessments of center/ORA PDUFA workload indicate that PDUFA workload is not in line with the distribution of resources in this plan, then adjustments may be made.
Because FDA plans to spend all funds it expects to collect, adjustments needed by the centers and ORA each year will generally be within the total amounts already planned for the fiscal year. For example, if an unplanned IT item becomes a high priority, then cutbacks will have to be made in other components of that organization’s plan (such as other IT items, hiring, or operating support) in order to fund that need.