The Biomedical Advanced Research and Development Authority (BARDA), a division of the U.S. Department of Health and Human Services (HHS), has released a significant new opportunity to strengthen national preparedness for burn mass casualty incidents (BMCIs). Through the Solicitation RFP #75A50125R00007, BARDA is seeking proposals for FDA-approved enzymatic debridement products for the treatment of deep and full-thickness burn injuries. This initiative directly addresses critical capacity gaps in burn care by supporting the procurement and advanced development of next-generation non-surgical treatments.
Building Resilience for National Health Emergencies
Burn injuries are among the most resource-intensive medical emergencies to treat. They require specialized surgical intervention, extended hospitalization, and coordinated long-term care. In a BMCI scenario, the U.S. health system’s limited burn care capacity could be quickly overwhelmed. BARDA has worked extensively with the clinical burn community to identify where innovation is needed most. Their findings point to two critical junctures: the initial triage and care phase, and the long-term treatment and recovery period.
This solicitation targets the second of these areas. The standard of care (surgical debridement) involves physically removing necrotic tissue (eschar), often along with healthy tissue, through invasive procedures. These surgeries are labor-intensive, delay definitive care, and require specialized surgical suites and staff. Enzymatic debridement products offer a non-surgical, bedside-ready alternative that selectively removes necrotic tissue while preserving viable skin, helping reduce complications, free up surgical resources, and improve patient outcomes.
Solicitation Structure and Program Objectives
BARDA’s approach is twofold: procure immediately available, FDA-approved enzymatic debridement products and support the development of next-generation formulations with enhanced stability, cost-efficiency, and use-case versatility (e.g., for blast trauma).
The program’s architecture is built around a Collaborative Access-Maintenance Vendor Managed Inventory (CAM-VMI) system that requires the awardee to:
- Establish and maintain a Preparedness Inventory of at least 2,750 product units, ready for rapid national deployment.
- Coordinate this inventory with their commercial supply (Planned Inventory) to rotate stock, prevent expiration, and streamline readiness.
- Participate in emergency deployment exercises and demonstrate the ability to ship within 24 hours of notice.
- Optionally, support the formulation, clinical testing, manufacturing, and regulatory approval of enhanced enzymatic debridement products with added value for national preparedness.
In total, the contract consists of a 10-year base period and six option periods covering product development, regulatory milestones, and expanded procurement.
Key Proposal Deadlines
Interested offerors should note the following critical dates:
- Questions Due: July 31, 2025, by 2:00 PM ET.
- Proposal Due Date: August 27, 2025, by 2:00 PM ET
Funding and Award Information
BARDA anticipates awarding one or more contracts under this solicitation. The contract structure includes both Firm-Fixed Price (FFP) and Cost-Plus-Fixed-Fee (CPFF) line items. Key features include:
- Base contract duration: 10 years
- Initial procurement: Minimum of 2,750 units of FDA-approved product
- Optional procurement: Up to an additional 5,000 units
- Advanced development options: Formulation R&D, clinical studies, U.S.-based manufacturing scale-up, and trauma use expansion
This structure provides both immediate impact through deployable product and long-term value through sustained innovation.
Supporting Human Health and Readiness
BARDA’s investment in enzymatic debridement products represents a forward-looking strategy to bolster the nation’s burn response capabilities while reducing reliance on surgical infrastructure. By enabling faster, safer, and more scalable burn care, the program enhances the U.S. healthcare system’s ability to respond to high-casualty events; whether due to industrial accidents, natural disasters, or intentional attacks.
The inclusion of optional funding for expanded indication applications further expands the preparedness utility of these products, offering the potential to treat a wider spectrum of complex injuries in both military and civilian settings.
EverGlade Consulting can help you develop a compelling BARDA proposal, manage registration and compliance, and navigate every phase of the award process. Reach out today to join the future of predictive biology. We offer services ranging from Pursuit, Proposal and Post-Award support to comply with federal regulations at agencies including BARDA, ARPA-H, NIH, DTRA, JPEO, DOD, DIU, DOE, and DARPA.
