Resource Capacity Planning
Description
FDA needs to accurately predict the volume and complexity of incoming drug application submissions to ensure appropriate staffing and resources are available for timely reviews under the user fee program
Detailed example
Forecasts workload submissions across major user fee programs to help support fee setting for the human drug review programs
AI / analytics pattern
Classical/Predictive Machine Learning: Models trained on data to make predictions or classifications based on identified patterns or relationships.
Automation level / stage
c) Deployed – The use case is being actively authorized or utilized to support the functions or mission of an agency.
Expected benefit
Forecasting human drug review program submissions and corresponding FDA workload to support better resource planning and ensure timely review of drug applications that benefit public health.
Controls / human review
ATO: Yes; PIA: Not published
Data needed
FDA systems including DARRTS and Panorama