Freeze-Dried Platelet Product for the Treatment of Trauma-Associated Blood Loss in Canines

Request for Information (RFI)

This RFI is issued by the Defense Health Agency (DHA), specifically the Operational Medical Systems (OPMED) Warfighter Protection and Acute Care (WPAC) Project Management Office (PMO), for market research purposes. The objective is to identify technologies for the development of a freeze-dried platelet product for treating trauma-associated blood loss in canines. This RFI is not a solicitation, and no contract will be awarded based on responses. The government may use the information to refine requirements or potentially issue a future solicitation.

The government is seeking information on canine freeze-dried platelet products with the following characteristics:

• Safe, efficacious, and shelf-stable for easy administration.
• Efficacy and stability at ambient temperature for at least one year (preferably three or more).
• Technology design and parameters related to efficacy, safety, reconstitution time/temperature, shelf-life stability, size/weight, and FDA (CVM) regulatory status.
• Assessment of Technology Readiness Levels (TRLs).
• Description of manufacturing state, potential locations, and scale-up.
• Summary of product classification and FDA approval pathway.
• High-level commercialization strategy.
• Past/present work with U.S. government organizations.

This RFI does not obligate the government to award a contract. The contract type is unknown at this time.

• Responses are due electronically by 2:00 PM Eastern on March 2, 2026, to katherine.j.ramsburgciv@health.mil.
• The email subject line must be: "RFI response for HT9427-26-RFI-703".
• Submissions should include a Capabilities Statement demonstrating the ability to perform the scope of work.
• A Rough Order of Magnitude (ROM) for research, development, testing, and FDA approval is requested.
• A high-level project timeline is also requested.
• Responses are limited to five (5) pages, including diagrams, references, and pictures.

Responses are appreciated from all capable and qualified sources, especially small businesses.

• Attachments include TRL definitions and Company & Product Information template.
• All proprietary information should be marked as such. The government reserves the right to use non-proprietary technical information in future solicitations.

Form / Attachment / Pricing Sheet

This document, "Attachment 2 - Company Product Information," is a form designed to collect specific company and product details from potential respondents. It serves as a standardized way for bidders to provide essential information required for the RFI (HT9427-26-RFI-703).

The form requests the following information:

• Company Name, Address, Point of Contact, Phone Number, E-mail Address
• Tax Identification Number (TIN), CAGE Code, UEI Number
• Company Web Page and Location(s)
• Small Business Status
• SAM Registration Status
• Other Socio-Economic Classifications (e.g., 8(a), HUB Zone, Woman-Owned, Veteran-Owned) and graduation date if applicable
• Possession of a current Indirect Rate Agreement or Forward Pricing Rate Agreement
• Acceptable cost accounting system status (DFARS 252.242-7006 or SF 1408 pre-award survey)
• Federal Supply Schedule (GS Contract Holder) information, including contract number if applicable

Bidders must complete this form accurately and thoroughly to provide the government with necessary information for evaluating their company's qualifications and eligibility for the opportunity. Failure to provide complete information may impact the assessment of the response.

Form / Attachment / Pricing Sheet

This document defines Technology Readiness Levels (TRLs) for certain canine veterinary medical products. It serves as a reference to understand the maturity of different aspects of product development.

The document outlines four major activity areas:

• M - Manufacturing Development
• S - Safety studies in Canines
• E - Efficacy studies in Canines
• R - Regulatory maturity (FDA Center for Veterinary Medicine)

Each activity area is mapped to specific TRLs (5, 6, 7, and 8), detailing the progress and validation stages within that area. For example, TRL 5 for Manufacturing Development indicates that a pilot lot has been produced to support initial safety and efficacy studies, while TRL 8 signifies that processes have been validated.

This attachment provides a framework for understanding the expected level of technological maturity for veterinary medical products. Bidders may need to reference these TRL definitions to assess their own capabilities, understand the government's expectations regarding product development stages, or to provide information related to the TRLs of their proposed solutions within a solicitation.