PDUFA IV 5-Year Financial Plan (2008): Annual Reassessments
This plan will be reassessed each year each year based on the latest information available. This information facilitates the resource allocation and planning for CDER, CBER, ORA and OC work required to meet the PDUFA IV goals. Actual workload and revenues will continue to be monitored closely.
If reassessments of CDER, CBER, ORA and OC drug-review related workload indicate that PDUFA workload is not in line with the distribution of resources in this plan, then adjustments may be made. If the adjustments are significant then the plan may be revised.
Because FDA plans to spend all funds it expects to collect, adjustments needed by CDER, CBER, ORA and OC 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.