Justification-and-Approval FDP-PLM-v5 signed redacted

CUI
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Justification and Approval (J&A) for Other than Full and Open Competition Revolutionary Federal Acquisition Regulation (FAR) Overhaul (RFO) Parts 6 and 12 Implemented by Class Deviation 2026-O0017, Revision 1
1. Identification of the Agency and Contracting Activity: Defense Health Agency (DHA), DHA Contracting Activity (DHACA), on behalf of the Portfolio Acquisition Executive Medical Products (PAE MP), Warfighter Protection and Acute Care Project Management Office (WPAC PMO), 1430 Veterans Drive, Fort Detrick, Maryland 21702. 2. Nature and/or Description of Action being Approved: This is an individual J&A requesting approval to award a new firm fixed price Research and Development contract to obtain the Product Lifecycle Management (PLM) activities necessary to sustain the commercial viability of a Single Donor, Type Specific, universal Freeze-Dried Plasma (FDP) product made by Vascular Solutions LLC (a subsidiary of Teleflex Incorporated).
3. Description of Supplies/Services and Estimated Value: PAE MP, WPAC PMO has a requirement to develop, license, and sustain a FDP product in accordance with the Department of War (DoW) Acquisition System, U.S. Food and Drug Administration (FDA) regulations and guidelines, and industry best practices. The purpose of this contract, for which sole-source authorization is sought, is for PLM activities necessary to sustain the commercial viability of a FDP product. PLM activities include shelf-life improvement development activities, characterization studies to increase the pool of available plasma starting material, international shipping validation studies, optimization studies for current manufacturing process to increase throughput, and next generation lyophilization bag container development. Bleeding is the leading cause of death on the battlefield. Management of severe hemorrhage due to trauma, in addition to requiring surgical repair of damaged organs and tissues, requires the replacement of large volumes of blood products, including plasma. Fresh frozen plasma (FFP) is the current standard of care for treatment of the coagulopathy of trauma. The availability of FFP on the battlefield is limited by the technical and operational logistic demands of the currently available products (FFP and thawed plasma). The DHA has a requirement to develop improved blood products in order to improve availability, reduce logistical burden, and minimize risk of severe bleeding and hemorrhage on the battlefield. A FDP product will make possible the