Amendment-RFI Questions Answered.docx

This document is an Amendment-RFI (Request for Information) with answers to specific questions about a potential ketamine-based analgesic for battlefield use. The RFI reveals the Department of War (DoW) is seeking a large-scale ketamine product solution with significant production capacity, estimating a steady-state monthly volume of 26,722 units and a surge capacity of 53,445 units per month for 24 months. The government is interested in various ketamine administration formats, including autoinjectors, oral capsules, pumps, topical creams, and patches, with the ultimate goal of developing a product that can receive FDA approval for tactical combat casualty care. The acquisition cycle currently focuses on U.S. requirements, with vendors expected to manage the complexity of potential NATO/ally purchasing alongside primary Department of War production needs.