Comprehensive Data Management & Streamlining Solution for Business-Critical Data (Data Stream)

The FDA’s Center for Tobacco Products is conducting market research to assess industry capability to deliver a comprehensive data‑management and streamlining solution (“Data Stream”) for business‑critical tobacco‑product submission data. Respondents must describe a solution that addresses a full suite of tasks, from inventorying existing FDA data sources, defining a product‑centric lifecycle framework, creating AI‑enabled metadata tagging for unstructured submissions, delivering prototype tools, and providing a final findings report. The effort is planned as a 12‑month firm‑fixed‑price contract, with numerous deliverables tied to a project schedule that will be established after award. • Perform a data inventory and baseline assessment of all FDA tobacco‑product submission data sources. • Develop product‑definition, lifecycle framework, and both conceptual and logical data models. • Build AI‑enabled metadata‑tagging structures and prototype applications to aid reviewer workflow, with optional proof‑of‑concept demonstrations. • Deliver extensive documentation, monthly status reports, project plans, agile roadmaps, and a final close‑out package within the 12‑month period.