*DARRTS DME & O&M, BA and Production Support New Contract

DARRTS is a component-based, multi-tier enterprise application accessed via a web-based interface. The system runs within the CDER intranet network and is only available to authorized users. DARRTS provides FDA users with the ability to receive, manage, track, and report on drug applications, delivering major advancements regarding flexibility, integration, and meeting CDER's business requirements. DARRTS helps the FDA provide better reports to Congress on a number of issues, including performance on PDUFA, GDUFA, and BsUFA. The purpose of this TO is to acquire services necessary for modifications and O&M of the DARRTS Program to support functional and interface changes, as well as enhancements to support additional PDUFA VII and GDUFA III requirements and the CDER Regulatory Review Process Modernization effort.