Battlefield Pain Management – Analgesic

This solicitation, identified as HT942726RE009 and titled Battlefield Pain Management – Analgesic, is issued under the Defense Health Agency’s prototype Other Transaction Authority (pOTA) authority pursuant to 10 U.S.C. § 4022 to acquire a single-use analgesic product for battlefield use, with the goal of achieving FDA approval for acute moderate to severe pain. The product must be administered rapidly and easily, possess a small physical profile for individual carry, and remain stable without refrigeration across extreme temperature conditions ranging from -25°C to 45°C, with a required shelf life of 2–3 years at controlled room temperature. It must comply with USP <659> packaging standards and meet stringent quality system requirements under 21 CFR Part 820, including labeling control and documentation of chemical composition. The product must be classified as DEA Schedule II or higher and may utilize a device-based delivery method such as a nasal spray or autoinjector, with physiological constraints limiting blood pressure and heart rate decreases to no more than 20% and preserving blood clotting capacity with minimal airway impact. The project spans an estimated eight years divided into three objectives—Chemistry, Manufacturing, and Controls (CMC) and stability studies over three years, non-clinical enabling studies over two years, and clinical trials and human factors testing over three years, contingent on successful completion of prior phases. Proposals must be submitted in three distinct volumes—Technical, Management, and Administrative and Cost—and adhere to strict formatting requirements including searchable PDF format, page limits for specified sections, and inclusion of a Microsoft Project file for the schedule. The submission window was extended from July 30, 2026, to August 14, 2026, with questions due by July 10, 2026, and must be sent via email to designated points of contact. Proposals must demonstrate at least one pass/fail gate condition: participation of a nontraditional defense contractor or nonprofit research institute to a significant extent; all significant participants being small businesses or nontraditional contractors; or cost-sharing from non-federal sources accounting for at least one-third of the total project cost. Evaluation focuses on technical approach, management strategy, and cost structure, with award determined by the most advantageous proposal. The agreement is not subject to the FAR or DFARS, except for referenced clauses such as DFARS 252.232-