Battlefield Pain Management – Analgesic

The Defense Health Agency Contracting Activity seeks development of a single-use, FDA-approved analgesic product for battlefield pain management under prototype Other Transaction Authority (10 U.S.C. 4022), with proposals due August 14, 2026 and questions due July 10, 2026. No more than two awards will be made.

To qualify for award, the proposal must satisfy at least one of three statutory conditions: include at least one nontraditional defense contractor or nonprofit research institution participating to a significant extent; ensure all significant participants are small businesses or NDCs; or demonstrate at least one-third of total project costs funded by non-Federal sources. The NAICS code is 541714, Research and Development in Biotechnology.

Place of performance includes Fort Detrick, Frederick, Maryland, with potential operations at CONUS and OCONUS sites. The product must be indicated for moderate to severe acute pain management during Tactical Combat Casualty Care in austere environments and serve as a replacement for discontinued DSUVIA and Oral Transmucosal Fentanyl Citrate products. Acceptable routes of administration are intramuscular, intranasal, oral, subcutaneous, or sublingual. The product must maintain a 2–3 year shelf life at controlled room temperature, operate from -25°C to 45°C without refrigeration, achieve rapid onset within 10 minutes with 30-minute analgesic duration, comply with 21 CFR Parts 58 and 11, and meet Trade Act Agreement requirements. Performers must demonstrate large-scale manufacturing and surge-production capability within one to two years of market release.

The estimated total period of performance is eight years: three years for Chemistry Manufacturing Controls and stability studies (Objective 1); two years for non-clinical enabling studies (Objective 2); and three years for Phase 1/2/3 clinical trials and human factors studies (Objective 3, executed after Objective 2 completion). Funding will be incremental. All prime awardees must register and maintain active SAM.gov status. Proposals must include three volumes: Technical Approach and Regulatory Strategy (20 pages); Management Approach with Integrated Master Schedule and Quality Management Plan (20 pages); and Administrative and Cost volumes including priced milestones and a completed Malign Foreign Talent Programs disclosure form. Amendment 0001 extended the proposal due date from July 30 to August 14 and clarified product and manufacturing requirements.