OCS Core Data Fitness Service

The Special Notice published by the Department of Health and Human Services Food and Drug Administration announces a sole-source award for the OCS Core Data Fitness Service. The FDA's Office of Finance Budget Acquisition and Planning intends to issue a single non-competitive award to provide data management and analysis services supporting the Core DataFitness Assessment for reviewing clinical and non-clinical study data. The contract will be valued at $689,620 and awarded to International Business Machines Corp (IBM) for a one-year performance period from September 15, 2025, to September 14, 2026. This announcement explicitly states it is not a request for proposal and that the government will not consider any information received for determining whether to conduct a competitive procurement. The services will be provided at the FDA facility located at 10903 New Hampshire Avenue Building 66 in Silver Spring, Maryland.

The purpose of this sole-source procurement is to maintain continuous support for the Office of Computational Science's Core DataFitness program, which provides automated data quality validation for clinical trial study submissions used in regulatory reviews. The FDA has classified this as mission-critical with zero allowable service gap, making the sole-source award necessary due to ongoing protests that have delayed competitive procurement efforts. IBM is being selected as the sole vendor because of its unique technological capabilities, proprietary analytical tools, and institutional knowledge of FDA systems that make it the only entity capable of providing the required specialized services. The procurement serves as a bridge contract while the FDA works to complete a competitive Blanket Purchase Agreement award by the beginning of fiscal year 2026. Contractors should note that this is a notification of exemption from fair opportunity rather than a solicitation, and no further competitive opportunities will be available for this specific requirement.