Cryopreserved Platelets (CPP) for US FDA Licensure
Closed Pre-Solicitation Posted
- Solicitation number
- HT9427-26-RFI-705
- Agency
-
Defense Health Agency
Department of Defense
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 541715 Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- PSC
- Not on record
- Place of performance
- Frederick, Maryland 21702, United States
Notice details come from SAM.gov. Updated .
About this opportunity
The Defense Health Agency is seeking industry input on the development and regulatory sponsorship of Dimethyl Sulfoxide (DMSO) Cryopreserved Platelets (CPP), a frozen biologic-platelet product designed to extend shelf life to two years or longer compared to conventional liquid stored platelets limited to 5-7 days. This Request for Information (RFI HT9427-26-RFI-705) represents early-stage market research to identify qualified commercial partners capable of serving as the Investigational New Drug (IND) application holder and regulatory sponsor for IND #14047. Responders must demonstrate technical expertise, FDA regulatory experience, and capability to execute all activities necessary for Emergency Use Authorization (EUA) and Biological License Application submission. Submissions are due electronically by 3:00 PM Eastern Time on May 4, 2026, and must include a white paper not exceeding 10 pages, a rough order of magnitude cost estimate, and a completed contact information table demonstrating qualifications. The RFI should be submitted to Peter Mitchell at peter.d.mitchell8.civ@health.mil with the subject line "Response to RFI for Cryopreserved Platelets (CPP)."
No set-aside designations apply to this procurement opportunity. This is a pre-solicitation notice that carries no obligation for the government to award a contract or conduct a future solicitation, and the Defense Health Agency reserves the right to use all submitted information for any legally appropriate purpose. Previous Phase 1 and Phase 2 clinical studies have already demonstrated in vivo viability and non-inferiority to liquid stored platelets in treating postoperative blood loss, indicating a mature product in development. The estimated period of performance for the EUA phase is no longer than 60 months, establishing a substantial timeline for regulatory and development activities. No specific award values or budget ranges are disclosed in this pre-solicitation notice, as this RFI is intended to gather preliminary information from the marketplace before formal procurement action.
Notice text
Defense Health Agency seeks to develop and manage medical materiel to protect and sustain the Warfighter on point for the Nation. We develop, directly through collaboration with commercial partners, medical products that enhance readiness and improve the quality of life of active-duty personnel in the operational environment. OPMED’s WPAC PMO has been developing a biologic product: Dimethyl Sulfoxide (DMSO) Cryopreserved Platelets (CPP), a frozen, biologic-platelet product. DMSO CPP are formulated to provide a platelet-derived product with a longer shelf life (2 years and potentially longer) than liquid stored platelets (LSP), which are currently licensed for storage up to 5-7 days at room temperature (20ºC to 24ºC) under gentle agitation.
Files
| File | Type | Posted |
|---|---|---|
| REQUEST FOR INFORMATION-HT9427-26-RFI-705 v1.docx | DOCX document | |
| REQUEST FOR INFORMATION -HT9427-26-RFI-705.docx | DOCX document |
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