Justification-and-Approval_HT942726RE014_FDP-PLM-v5_signed(2)_redacted_final.pdf

CUI

Control Number:

Controlled by: Defense Health Agency (DHA) Controlled by: Defense Health Agency Contracting Activity (DHACA) CUI Category(ies): Source Selection Limited Dissemination Control: FEDCON

CUI

Source Selection Information - See RFO FAR 2.101 and 3.104-4

OCT 2024

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 fielding of plasma farther forward on the battlefield to allow greater capability across decisive actions, where and when needed, in a manner consistent with current and future operations.

CUI

Source Selection Information - See RFO FAR 2.101 and 3.104-4

OCT 2024

In 2013, the FDA approved Octaplas™, manufactured by Octapharma, an Austrian company.

Octaplas™ is a pooled plasma product that is solvent detergent treated and frozen. Octapharma received European regulatory approval in 2023 for OctaplasLG Powder, a freeze-dried form of the OctaplasLG™ starting material. Octapharma received an EUA from the FDA on August 8, 2024, for emergent treatment of hemorrhage or coagulopathy involving agents of military combat (e.g., firearms, projectiles, and explosive devices) when plasma is not available or when the use of plasma is not practical. PAE MP entered into a CRADA with Octapharma for EUA use/Adverse Event reporting, etc. PAE MP, WPAC PMO also has an IDIQ supply contract (HT942525DE004) with Octapharma for procurement of FDP EUA product.

The PAE MP, WPAC PMO is also working with Vascular Solutions LLC (a subsidiary of Teleflex Incorporated) to complete required activities for licensure of their EZPLAZ FDP product. Vascular Solutions LLC resubmitted their FDP BLA to the FDA in September 2025.

The FDA conducted a Pre-Approval Inspection of Vascular Solutions LLC manufacturing facility in December 2025.

Vascular Solutions LLC is currently working to complete the required activities as requested by the FDA during the Pre- Approval Inspection and BLA review. The BLA review date is 29 July 2026.

There is an effort by Velico Medical, LLC, funded by the Biomedical Advanced Research and Development Authority, to develop a Spray-Dried Plasma system for use in blood banks.

Velico's business models are to sell the device and consumables to blood centers who would then make their own FDP product. Velico is currently preparing to conduct a Phase 3 study estimated to being in early 2027. The German Red Cross and the National Bioproducts Institute aren’t currently interested in pursuing an EUA or FDA approval at this time. Octapharma has filed an EUA for their OctaplasLG Powder .

9. Other Facts:

a. Procurement History:

(1) Is this a new requirement? No. See section 9.b for additional information.

(2) If 9.a.(1) is No, was the action just prior to this one competed? No.

(3) If 9.a.(2) is Yes, what has changed where this action cannot be competed? Not Applicable.

b. Additional Information:

(1) W81XWH-20-C-0088 was awarded on a sole source basis to Vascular Solutions LLC based on Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency

CUI

Source Selection Information - See RFO FAR 2.101 and 3.104-4

OCT 2024

Requirements. No responses were received referencing the Sole Source Justification posted to SAM.gov.

(2) W81XWH-20-C-0088 was awarded on 9/9/2020; performance started on that same day and ended on 12/31/2025. The purpose of W81XWH-20-C-0088 was to conduct several activities necessary to successfully obtain and sustain commercial viability of a FDA licensed FDP product. Specific aims included support for a new Sterile Water For Injection (SWFI) supplier, support for the transfer of sponsorship, support for quality by design for process improvement to production sustainment, activities to increase production throughput and minimize human error, and activities for the modification of the dehumidification system in the transfer room.

(3) Based on the results of the market research completed for the previous justification, no actions were taken to increase competition. The FDP IPT continues to monitor other development efforts.

(4) No prior contract for this requirement was accomplished using full and open competition.

(5) There are no explanations of any unusual patterns that have been revealed by the history (e.g., several consecutive, urgent buys).

(6) There have not been significant changes. Vascular Solutions LLC remains uniquely positioned to execute the necessary development activities to successfully obtain PLM activities necessary to sustain the commercial viability of a Single Donor, Type Specific, universal FDP product. Vascular Solutions LLC has already resubmitted their BLA to the FDA and continues to complete the required activities as requested by the FDA during the Pre-Approval Inspection and BLA review. Vascular Solutions LLC will be the regulatory sponsor of the BLA and will manufacture, market, and distribute the FDP product. There are no other FDA approved Dried Plasma products available.

10. Interested Sources: In response to SSN HT942726RE014 one source expressed interested via the ‘Interested Vendor’ feature for the notice. SPMC International, LLC is a one-person consulting firm. In response to NOI HT942726RE014 one source expressed written interest.

SemperMade submitted a capability statement in response to the NOI. The Government has determined that SemperMade cannot meet the requirements as the firm is not a dried plasma manufacturer and states as such in their response. SemperMade also cannot conduct the characterization studies or stability studies that the Government is requesting to be performed under the resultant contract. To date, no other sources have written to express an interest.

CUI

Source Selection Information - See RFO FAR 2.101 and 3.104-4

OCT 2024

Certifications

11. Technical & Requirements Certifications:

I certify the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

12. Legal Review:

I have reviewed this justification and have found it to be legally sufficient.

13. Contracting Officer Determination of Fair and Reasonable Pricing and Certification of Accuracy and Completion.

Fair and Reasonable Cost Determination:

I hereby determine that the anticipated cost to the Government for this contract action will be fair and reasonable.

CUI

Source Selection Information - See RFO FAR 2.101 and 3.104-4

OCT 2024

CUI

Source Selection Information - See RFO FAR 2.101 and 3.104-4

OCT 2024

Approval Based on the foregoing justification, I hereby approve the procurement of PLM activities necessary to sustain the commercial viability of a FDP product in the amount of on an other than full and open competition basis pursuant to the authority of RFO 6.103-1(a) Only one responsible source and no other supplies or services will satisfy agency requirement, subject to availability of funds, and provided that the supplies and/or services herein described have otherwise been authorized for acquisition.