Prototype development for Battlefield Wound Infection Prevention and Treatment (BWI P&T) Barrier Combination

The Defense Health Agency Contracting Activity seeks prototype development of a Battlefield Wound Infection Prevention and Treatment (BWI P&T) Barrier Combination product—a combination wound treatment with a physical barrier infused or impregnated with antimicrobial and/or antifungal properties requiring FDA approval or clearance—with proposals due November 6 at 12 p.m. Eastern and questions due October 2. This is a single-award prototype Other Transaction Authority procurement under 10 U.S.C. 4022, not subject to FAR or DFARS except where expressly referenced.

Place of performance is Frederick, Maryland (Fort Detrick) and performer U.S. facilities and clinical trial sites. Statutory eligibility requires that at least one nontraditional defense contractor or nonprofit research institution participate significantly; or all significant participants other than the Government be small businesses or nontraditional contractors; or at least one-third of total project costs be funded by non-Federal parties. All offerors must register in SAM.gov with NAICS 541715 and serve as FDA Sponsor per 21 C.F.R. 312 Subpart D.

The estimated period of performance is 54 months total: Objective 1 (24 months) on preclinical testing and prototype development; Objective 2 (24 months) on clinical studies and FDA regulatory submissions, conducted simultaneously or overlapping but not exceeding 48 months combined; and Objective 3 (6 months) for FDA approval notification. The final product must achieve Technology Readiness Level 7 upon FDA submission and TRL 8 upon FDA approval or clearance, with minimum 12-month shelf-life and barrier integrity for at least 24 hours on a wound.

The Government prefers Firm Fixed Price but accepts Cost-Plus Fixed Fee. Funding will be incremental. Proposals are organized in three volumes: Technical (20-page limit for approach, plus Statement of Work with milestones); Management (20-page limit for Project Management Plan, Risk Management, Staffing, Subcontractor Management, Commercialization, and Regulatory Strategy); and Administrative and Cost/Price (FDA Form 1571, Warranties and Representations, cost templates, and supporting documentation). The NAICS code is 541715; PSC is AN13.