DataFit Operation and Maintenance

The Food and Drug Administration's Center for Drug Evaluation and Research requires professional services to install, update, support, and develop enhancements for DataFit, the agency's data standards validation platform. This combined firm-fixed-price and labor-hour contract, identified as FDA-75F40126Q00317, encompasses a base year from September 28, 2026, to September 27, 2027, with two subsequent one-year option periods and a possible six-month extension. Performance is primarily based at the contractor's site, though in-person meetings are required at FDA facilities in Silver Spring, Maryland. The scope of work includes end-to-end project management following the HHS Enterprise Performance Life Cycle, agile methodologies, and compliance with NIST, OMB, and Section 508 accessibility standards. Key deliverables include management plans, monthly status reports, and technical documentation such as version description and operations and maintenance plans. Award will be determined via a best-value trade-off analysis, prioritizing prior experience and technical approach over price. The technical evaluation focuses on management approach and risk mitigation strategies, with confidence ratings of high, medium, or low assigned to non-price factors. Security requirements are stringent, requiring Tier 2 background investigations for personnel, PIV card issuance for long-term facility access, and FIPS 140-2 validated encryption for data at rest and in transit. All invoicing must be processed electronically through the U.S. Department of Treasury’s Invoice Processing Platform. Proposals must be submitted in two volumes by August 22, 2026, with strict adherence to page limits and formatting guidelines.