A02 RFI for FREEZE-DRIED PLATELET CANINE_wgh.pdf

REQUEST FOR INFORMATION (RFI)

for

FREEZE-DRIED PLATELET PRODUCT FOR THE TREATMENT OF TRAUMA-ASSOCIATED BLOOD LOSS IN

CANINES

THIS IS NOT A REQUEST FOR PROPOSALS (RFP) OR A REQUEST FOR QUOTATIONS

(RFQ). IT IS STRICTLY A REQUEST FOR INFORMATION (RFI). NEITHER UNSOLICITED

PROPOSALS NOR ANY OTHER KINDS OF OFFERS WILL BE CONSIDERED IN RESPONSE TO

THIS RFI. NO CONTRACT/ORDER WILL BE AWARDED PURSUANT TO THIS

ANNOUNCEMENT.

Disclaimer: The purpose of this RFI notice is to gain market knowledge. This notice does not obligate the Government to award a contract/order or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's solution and qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a synopsis and/or solicitation may or may NOT be published at a future date and time.

1.0 RFI Number: HT9427-26-RFI-703

2.0 RFI Issuing Office: Defense Health Agency Contracting Activity (DHACA) - Research & Development 2

3.0 RFI Issue Date: January 30, 2026

4.0 RFI Title: Freeze Dried Platelet Product for the Treatment of Trauma-Associated Blood Loss in Canines

5.0 Agency: Defense Health Agency (DHA)

6.0 Office: Operational Medical Systems (OPMED) Warfighter Protection and Acute Care (WPAC) Project Management Office (PMO)

7.0 Location: Frederick, MD (on Fort Detrick)

8.0 Contract Type: Unknown

In accordance with Federal Acquisition Regulation (FAR) 15.201 "Exchange with industry before receipt of proposals," this RFI is for information and planning purposes only at this time and shall not be construed as a solicitation or as an obligation on the part of the DHA, DHACA, or any collaborative Department of Defense (DoD) activities.

This RFI is for information and planning purposes only and is neither to be construed as a commitment by the Government nor will the Government pay for information solicited. Respondents are solely responsible for all expenses associated with responding to this RFI. No evaluation letters and/or results will be issued to the respondents. Currently, no solicitation exists; therefore, please do not request a copy of the solicitation.

NO PHONE CALLS WILL BE ACCEPTED OR RETURNED.

Neither unsolicited proposals nor any other kind of offer will be considered in response to this RFI.

Responses to this notice are not offers and will not be accepted by the Government to form a binding contract. In keeping with the standards of FAR Part 10, the Government may request additional information from responders. Responders are solely responsible for all expenses associated with responding to this RFI or any follow-up information request. All information received in response to this RFI or any follow-up information request that is marked “Proprietary” will be handled accordingly. Responses to the RFI will not be returned. At this time, questions concerning the composition and requirements for a future request for proposal will not be entertained.

9.0 Background: The OPMED is conducting market research to identify technologies that meet requirements for the development of a freeze-dried platelet product for the treatment of trauma-associated blood loss in canines. This market research may also assist with the further development and/or refinement of the requirements.

10.0 Objective and Purpose/Scope: Military Working Dogs (MWDs) play a critical role in protecting human lives and supporting military objectives in the operational environment. MWDs work in close conjunction with their handlers and Service Members and are exposed to the same combat trauma threats and similar non-battle injury risks, and thus canine blood or blood components are indicated for appropriate treatment.

The OPMED has a requirement to develop, deliver, and field safe and effective Canine Blood Products (CBP) for the treatment of traumatic hemorrhage. The CBP program is using a Family of Systems (FoS) approach that aims to develop multiple medical materiel solutions that are most relevant for use in austere environments where medical products and evacuation may be limited.

This RFI seeks responses to the canine freeze-dried platelet component of this FoS only.

11.0 North American Industry Classification System (NAICS) Code:

12. RFI Attachments: The following documents are attached to the RFI o Attachment 1: Technology Readiness Levels (TRLs) (Reference Only) o Attachment 2: Company & Product Information

13. Response Due Date: Interested parties shall submit the RFI response electronically by 2:00pm Eastern on March 2, 2026, via e-mail to:

Katherine Ramsburg via email at: katherine.j.ramsburgciv@health.mil Email Subject/title: "RFI response for HT9427-26-RFI-703”

14. SUBMISSION INSTRUCTIONS:

14.1 The Government appreciates responses from ALL capable and qualified sources, especially small businesses.

14.2 CAPABILITIES STATEMENT: Interested firms should submit a capabilities statement that demonstrates the Respondent's ability to perform the scope of work identified in this RFI. The Capabilities Statement should address the following topics:

CHARACRTERISTICS:

The canine freeze-dried platelet product should have the following desired characteristics:

• Provide a safe, efficacious, and shelf-stable canine platelet treatment that is easy to administer.

• Maintain efficacy and stability during storage at ambient temperature (extreme temperatures preferred) for at least one year (three years or more is preferred).

TECHNOLOGY:

Technology design and parameters under development with respect to:

o Efficacy as compared to fresh platelet concentrate o Evidence of safety o Reconstitution time and temperature o Shelf-life stability (time and temperature) o Size and weight o FDA (CVM) regulatory status

• Assessment of Technology Readiness Level (TRL), based on the attached TRL definitions.

• Provide a description of the state of technology manufacturing, potential manufacturing locations, and scale up required for commercial production.

mailto:katherine.j.ramsburgciv@health.mil

FOOD & DRUG ADMINISTATION (FDA):

• A summary of product classification and the regulatory pathway to FDA approval of the technology, including anticipated nonclinical, clinical, and laboratory studies necessary and expected time to achieve approval.

COMMERCIALIZATION:

• High-level commercialization strategy.

PAST/PRESENT WORK:

• Any past or present connections to U.S. government organizations, programs, or personnel

OTHER:

• Any other information that may be relevant to product development, to include geographic sources of manufacturing and source materials

14.3 ROUGH ORDER OF MAGNITUDE (ROM): The total estimated cost for research, development, testing and FDA approval should be provided.

14.4 PROJECT TIMELINE: A high-level timeline of major activities that relate to research, development, testing, manufacturing, and regulatory approval should be provided.

14.5 ATTACHMENT 2: Completed Company & Product Information

Responses should adhere to the following formatting and outline instructions:

Cover Page (1 page)

14.5.1 Title

14.5.2 Organization

14.5.3 Responding technical and administrative points of contact (names, addresses, phone, and email)

14.5.4 Topic area: “FREEZE DRIED PLATELET PRODUCTION FOR THE TREATMENT OF TRAUMA-

ASSOCIATED BLOOD LOSS IN CANINES”

Format Specifications & Page Limitations:

Arial 12-point font, single spaced, single sided, 8.5 by 11- inch paper with 1-inch margins. All submissions shall be made electronically (as described above) and be in one of the following formats:

Microsoft Word or searchable Adobe PDF. Responses shall be limited to five (5) pages, including diagrams, references, and pictures.

15.0 Confidentiality: All 'Proprietary', 'Classified', 'Confidential', or 'Sensitive' information shall be marked as such and will be treated accordingly. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s). All submissions become Government property and will not be returned.

(End of RFI)