Contractor-Hosted Fully Integrated Records Facility (FIRF) IDIQ

The FDA is seeking a Service‑Disabled Veteran‑Owned Small Business (SDVOSB) to operate a contractor‑hosted Fully Integrated Records Facility (FIRF) that will receive, process, store, and distribute FDA regulatory submissions and other records. The contractor must provide a secure 20,000 sq ft (or larger) facility within 60 mi of the FDA White Oak Campus, meet stringent federal information‑security and physical‑security requirements, and supply all personnel, equipment, courier services, and IT infrastructure needed to support six major task areas, including same‑day processing of at least 95 % of submissions. The contract is an IDIQ with a five‑year ordering period (plus a possible six‑month extension) and a ceiling of $50 M; pricing will be based on fully‑burdened labor rates and a sample task‑order total of about $1.9 M. • Provide a secure FIRF facility (≥ 20,000 sq ft) within 60 mi of Silver Spring, MD. • Perform document receipt, scanning, data‑entry, tracking, courier, and records‑management functions for FDA’s pre‑market and post‑market activities. • Meet extensive security, privacy, FedRAMP, CUI, and HIPAA compliance standards, and submit required key‑personnel resumes and commitment agreements.