The Division of Preclinical Innovation (DPI) at the National Center for Advancing Translational Sciences (NCATS) conducts translational research in the area of human therapeutics development and aims to move small molecule and biologic drug candidates forward in the drug development pipeline, at which point, DPI will hand off the drug candidate to external partner(s) to bring the novel therapy to patients. The overall goal of this project is to support safety evaluations that are of interest to NCATS by conducting various toxicology studies. Specifically, to help identify, develop, and perform in-vitro and in-vivo IND/NDA/BLA-enabling safety studies for small and large molecules. In addition, in vitro tests and in-vivo exploratory studies will be carried out to aid therapeutic target evaluation, lead optimization, and compound selection processes on a case-by-case basis. To accomplish this goal, the Government plans to solicit proposals from offerors having in-house capability in one or more of the following technical areas: (1) Exploratory and Genetic Toxicology and (2) In-Vivo Toxicity Testing.