Battlefield Pain Management – Analgesic

This solicitation under the Prototype Other Transaction Authority (10 U.S.C. § 4022) seeks innovative analgesic solutions for battlefield use, with the goal of achieving FDA approval for a single-use product intended to manage acute moderate to severe pain in combat settings. The product must be rapid to administer, compact in size and weight for individual carrying, and capable of functioning without refrigeration across extreme temperatures ranging from -25°C to 45°C while maintaining a 2-3 year shelf life at controlled room temperature. It must comply with USP <659> and MIL-STD-810 environmental standards, adhere to 21 CFR Part 820 quality system requirements for labeling and packaging, and meet strict physiological limits including no more than a 20% reduction in blood pressure, heart rate, or clotting ability, with only minor, non-ventilation-required airway changes. The product must be classified as a DEA Schedule II or higher controlled substance and may be delivered via nasal spray or autoinjector. The effort spans eight years, divided into three phases: three years for Chemistry Manufacturing Controls and stability studies, two years for non-clinical enabling studies, and three years for clinical trials and human factors testing culminating in potential EUA submission. The contract is structured as an Other Transaction Agreement exempt from FAR and DFARS, except where explicitly referenced, and is not subject to Bayh-Dole provisions. Proposals must demonstrate at least one of three pass/fail conditions: inclusion of a significant nontraditional defense contractor or nonprofit research institution, all non-federal participants being small businesses or nontraditional contractors, or at least one-third of project costs being privately funded. Evaluation focuses on technical approach, management strategy, and cost, with no assigned weights provided. Submission requires three clearly organized volumes in searchable PDF format, accompanied by a Microsoft Project plan, with strict formatting rules prohibiting embellishments. All participants must be registered in SAM with an active UEI and CAGE code, and must include NAICS code 541714. Compliance with prohibitions on malign foreign talent programs is mandatory, requiring certification and disclosure of foreign affiliations, ownerships, and funding sources. Payment occurs through WAWF using NPI, cost vouchers, or invoices tied to CLINs and ACRNs, with acceptance managed by an Agreement Officer Representative. Data deliverables, including CMC reports, clinical study outcomes, and regulatory filings, are governed by CDRL and DID attachments