Notice of Intent to Sole Source PROMETHEUS FEDERAL SERVICES LLC

The Department of Health and Human Services Food and Drug Administration Office of Acquisition and Grant Services has issued a Special Notice for a potential sole-source contract with Prometheus Federal Services LLC. The notice pertains to a cybersecurity project for the Center for Devices and Radiological Health (CDRH) involving Software Bill of Materials (SBOM) Validation and Reporting. This opportunity is specifically set aside for a Service-Disabled Veteran-Owned Small Business and was posted on May 2, 2025, with a response deadline of May 9, 2025. The contract is not initially being competed, but the government will consider alternative vendors who can demonstrate capability to meet the requirement. The notice invites potential contractors to submit written capability statements that clearly show their ability to perform the specified work.

The primary objective of this project is to develop and maintain a system for analyzing and reporting cybersecurity vulnerabilities in medical devices with software, hardware, or firmware components. Interested contractors must submit their capability statements via email to Hilda Aryeh by 3:00 PM EST on May 9, 2025. The contract is structured as a firm fixed-price agreement with a 5-month base period and two 12-month option periods, running from September 1, 2025 to February 23, 2028. Work will primarily be performed remotely from the Washington DC area, with potential on-site interactions at the FDA's White Oak Campus. Contractors must be prepared to comply with strict security, privacy, and Section 508 accessibility standards, and be capable of handling sensitive government information. The project requires comprehensive documentation, detailed record-keeping, and adherence to specific training and incident response protocols. While the government intends to award the contract to Prometheus Federal Services LLC, they reserve the right to compete the contract based on received capability statements.