Definitive Contract 75F40119C10021

This is a firm-fixed price contract awarded by the U.S. Food and Drug Administration (FDA) to the Icahn School of Medicine at Mount Sinai (Icahn School) for a research project titled "PREDICTOX- A KNOWLEDGE ENVIRONMENT FOR PREDICTION OF DRUG INDUCED ADVERSE EVENTS". The potential value of the contract is $1,400,000.00. The contract does not have a set-aside designation. The Icahn School, a private university and non-profit organization, will be the prime contractor performing the research. The Critical Path Institute (C-Path), a non-profit organization, has been identified as a major subcontractor responsible for developing a database to host clinical and preclinical data related to drug-induced toxicity, as well as establishing quality control processes, developing prediction models, and creating user interfaces. This contract supports the FDA's efforts to advance regulatory science and improve decision-making in drug development and evaluation.