The FDA is seeking a Service‑Disabled Veteran‑Owned Small Business (SDVOSB) to operate a contractor‑hosted Fully Integrated Records Facility (FIRF) under an Indefinite Delivery‑Indefinite Quantity (IDIQ) contract. The contractor will provide end‑to‑end records‑management services—including receipt, processing, scanning, cataloguing, storage, data entry, redaction, courier, and transition support—for both paper and electronic regulatory submissions. The IDIQ will span a five‑year ordering period with a guaranteed minimum of $10,000 and a ceiling of $50 million, allowing Time‑and‑Materials, Labor‑Hour, and Firm‑Fixed‑Price task orders. The facility must be within 60 miles of FDA’s White Oak Campus, be at least 20,000 sq ft, and support a dedicated Verizon data line. Key responsibilities include 95 % same‑day processing, secure handling of confidential records, and integration with FDA’s tracking systems.
• Operate an off‑site FIRF supporting FDA’s regulatory document flow (≈3.5 M submissions FY2025)
• Provide mailroom, scanning, digitization, data‑entry, and secure storage services
• Maintain a secure, FDA‑authorized IT environment with direct data‑cable connectivity
• Deliver same‑day processing for 95 % of submissions and expedited courier services (1‑2 hr)
• Manage transition‑in/out, facility security, and compliance with Federal Records Act and FISMA
• Submit fully burdened labor rates; contract may be exercised via T&M, LH, or FFP task orders