FDA Safety And Innovation Act Support Services (FDASIA)

The FDA Safety and Innovation Act Support Services (FDASIA) Blanket Purchase Agreement (BPA) is a multiple-award contract vehicle established under the Professional Services Schedule to support the Food and Drug Administration's (FDA) technology modernization, data management, and regulatory process improvement initiatives. Based on the Professional Services Schedule solicitation, the BPA enables federal agencies to procure comprehensive professional services across various domains, including business consulting, program support, IT services, and strategic analytics. The contract vehicle specifically focuses on delivering integrated solutions to support the FDA's Center for Drug Evaluation and Research (CDER) in modernizing its informatics, drug review, and safety platforms.

The BPA has primarily been utilized by task orders awarded to three major professional services firms: Deloitte & Touche LLP, Booz Allen Hamilton Inc., and Accenture Federal Services LLC. Typical task orders range from $3 million to $18 million in value, with performance periods typically spanning 12 to 24 months. Key service scopes include drug safety platform analytics, workflow optimization, IT strategy development, business process management, and informatics platform support. The task orders are consistently awarded on a labor hours or time-and-materials pricing basis, with no specific small business set-aside designations. Performance locations are predominantly in Silver Spring, Maryland, and the work directly supports the FDA's mission of enhancing medical product safety, regulatory review processes, and technological capabilities through initiatives mandated by the Food and Drug Administration Safety and Innovation Act.