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

Background
The U.S. Food and Drug Administration (FDA) and the Center for Drug Evaluation and Research (CDER) are committed to protecting public health. The Office of Surveillance and Epidemiology (OSE) evaluates drug risks and promotes safe drug use among the American populace. This contract aims to enhance FDA's capabilities in accessing hospital drug utilization data, which is critical for monitoring drug safety and effectiveness post-marketing.

The recent enactment of PDUFA VII emphasizes the need for modernized data systems to support FDA's regulatory decision-making processes.

Work Details
The contractor will provide continuous access to hospital drug utilization data for adult and pediatric patients, including:
1. Automated access to existing commercial data resources for short-stay hospitals, including pediatric specialty hospitals and Emergency Departments.
2. Capability to describe national patterns of drug utilization through scientifically sound methodologies.
3. Unlimited internet access via an interface tool for real-time data retrieval.
4. Ability to download large datasets for epidemiological studies.
5. Data must include discharge-level and patient-level information, including demographics, diagnoses, drugs administered, and treatment procedures.
6. Continuous quality control measures ensuring valid data access that meets contract requirements.

Period of Performance
The contract will be performed over a base period of 12 months with four one-year options, starting from May 12, 2025.

Place of Performance
The primary place of performance will be at the Contractor’s facility, with onsite meetings at FDA’s main campus in Silver Spring, Maryland.