The purpose of this contract is to establish a Division-wide Regulatory Management Center to: (1) centralize all regulatory support services for DAIT-funded clinical research programs, currently carried out under multiple grants and contracts, into a single contract dedicated to regulatory affairs; (2) provide regulatory support services for individual clinical trial projects conducted under investigator-initiated cooperative agreement grants within a centralized contract; and (3) provide regulatory support services for future DAIT-supported clinical research programs and individual projects.