Regulatory Decision Frameworks and Predictive Modeling

The contract involves the development of AI and machine learning-driven predictive models and decision support tools aimed at enhancing regulatory decision-making processes. Leveraging both high-quality scientific data and real-world data, the objective is to improve the accuracy and efficiency of regulatory evaluations. This initiative is critical for advancing the FDA's ability to assess and manage health-related risks more effectively. This subcontract falls under the NAICS code 541990 and is managed by the FDA Office of Acquisitions and Grants Services within the Department of Health and Human Services. The work will be performed in Silver Spring, Maryland, and focuses on creating frameworks that support regulatory decisions through sophisticated data analysis and predictive modeling techniques. The contract was posted in January 2026 and seeks specialized expertise to integrate innovative technologies into regulatory workflows.