Evaluation of FDA Resource Capacity Planning and Time-Reporting Systems

The U.S. Food and Drug Administration (FDA) wanted to evaluate its Resource Capacity Planning (RCP) capability and time-reporting systems for three of its programs: the Prescription Drug User Fee Act (PDUFA) program, Biosimilar User Fee Act (BsUFA) program, and Generic Drug User Fee Amendments (GDUFA) program. Specifically, FDA wanted to evaluate (1) how effective the Capacity Planning Adjustment (CPA) is in forecasting resource needs, and how effective the CPA workload drivers are in representing the program workload; (2) opportunities for enhancing FDA’s time-reporting systems to inform human resource needs; and (3) how the programs integrated and utilized RCP information within their resource and operational decision-making processes. FDA tasked ERG with performing the assessment.

ERG developed an evaluation framework (including the objectives, questions, and metrics to answer the evaluation questions) and then interviewed FDA experts and collected FDA documentation and data relevant to answering the evaluation questions. ERG prepared a report (Evaluation of FDA Resource Capacity Planning for PDUFA, BsUFA and GDUFA) that summarized the findings and provided recommendations to improve FDA’s RCP capabilities, including the CPA and time-reporting systems. We presented the evaluation results at a public meeting on PDUFA, BsUFA, and GDUFA efficiency, providing a roadmap for advancing FDA’s resource planning and operational capabilities.