Contractor-Hosted Fully Integrated Records Facility (FIRF) IDIQ

The FDA is seeking a single‑award IDIQ contract to provide a Contractor‑Hosted Fully Integrated Records Facility (FIRF) that will support the agency’s regulatory submission processing, records management, and related courier services. The contractor must operate an off‑site facility within 60 mi of FDA’s White Oak Campus, meet stringent security (CUI, HSPD‑12, FedRAMP) and records‑management standards, and staff the contract with fully‑burdened labor rates across multiple labor categories. The IDIQ will have a five‑year ordering period (with a possible six‑month extension) and a ceiling of $50 M, allowing Time‑and‑Materials, Labor‑Hour, and Firm‑Fixed‑Price task orders. • Operate a ≥ 20,000 sq ft off‑site FIRF facility, ≤ 60 mi round‑trip from Silver Spring, MD, with Verizon data‑cable connectivity. • Provide end‑to‑end document handling: receipt, same‑day processing (≥ 95 %), scanning, data entry, tracking, secure storage, and courier services for FDA reviewers. • Comply with extensive security and privacy clauses (FISMA, NIST 800‑53, FedRAMP, HIPAA BAA, CUI), maintain an Authority‑to‑Operate, and submit monthly and quarterly performance and security reports. • Submit fully‑burdened hourly rates for each labor category; price task orders against those rates under an LPTA evaluation (technical acceptability first, then lowest price).