This contract will support the conduct of regulatory toxicological and pharmacological studies with potential cancer preventive agents to enable or advance human clinical trials. As such, the data from these studies must be suitable for filing with the Food and Drug Administration as part of Investigational New Drug Applications (IND) or New Drug Applications (NDA). Successful Contractors shall perform studies in two or more of the following Technical Task areas: genotoxicity testing; general toxicology in experimental animals; reproductive toxicology studies in rodents and rabbits; and specialized studies as needed. Specific Task Orders will be submitted to successful Contractors to support the regulatory requirements of specific candidate agent(s), depending on the characteristics of the agent and its position along the drug development pathway. Tasks shall be conducted in accordance with quality oversight that is appropriate to the phase of the specific task and within all applicable and current federal, state, and local laws, codes, ordinances and regulations, as well as all PHS Safety and Health provisions as applicable. The tasks shall also comply with applicable FDA and/or International Conference of Harmonisation (ICH) guidance including, but not limited to, those listed in the Addendum to this Statement of Work.
