Data Resource Management For Human Drug Review

The Data Resource Management for Human Drug Review Master Blanket Purchase Agreement (BPA) is a federal contract vehicle established by the Food and Drug Administration (FDA) to procure comprehensive data management, information technology, and support services for the Center for Drug Evaluation and Research (CDER). The vehicle enables the FDA to rapidly acquire specialized services related to electronic submissions management, knowledge management, data analytics, and integrated information systems support. Task orders under this BPA primarily focus on enhancing the FDA's technological capabilities for processing, analyzing, and managing drug-related data and submissions.

The BPA has predominantly been awarded to Booz Allen Hamilton Inc. and Octo Consulting Group, LLC, with task order values ranging from approximately $2.3 million to $7.6 million and performance periods typically spanning 1-2 years. Recent task orders have included specific projects such as Over-the-Counter Monograph User Fee Program support, Submission Data Support, Integrated Data Management Enhancements, and ICIMS deployment services. The contract vehicle consistently utilizes labor hours and time-and-materials pricing mechanisms and does not employ specific set-aside designations. Most task orders are centered in Silver Spring, Maryland, and support the FDA's mission of managing and reviewing human drug applications through advanced technological solutions and data management practices.