Drug Utilization: Hospital Inpatient & Emergency Dept. Data (Recompete)

CDER Mission Justification: This data source is used to track inpatient drug utilization and drug shortages to inform multiple reviews. This budget item, which is neither IT nor research, allows FDA access to the only available data source that provides visibility to inpatient and emergency room drug utilization patterns. Therefore, a lapse in access will prevent CDER from responding to inquiries requiring the use of these data. Fund Type Rationale: Funding to ensure program continuity. The funding is split evenly between PDUFA and GDUFA because Hospital Inpatient Drug Utilization Data is used to support safety reviews, advisory committee meetings and other internal and external presentations for both new drugs and generic products. The cost estimate was based on historical information and an increase of 5% on current option year amount (