FDP_Sources_Sought_Notice_EUA product_20August2024v1.docx

Sources Sought Notice

1. SSN Number: HT9425-24-SSN-TJK2

2. SSN Title: Freeze Dried Plasma (FDP) Emergency Use Authorization or FDA Licensed Product

3. Agency: United States Army Medical Research and Development Command (USAMRMC)

4. Office: United States Army Medical Materiel Development Activity (USAMMDA)

5. Contracting Office: United States Army Medical Research Acquisition Activity (USAMRAA), Fort Detrick, Frederick, MD.

6. Location: TBD

7. Synopsis: In accordance with Federal Acquisition Regulation (FAR) 15.201, "Exchange with industry before receipt of proposals," this Sources Sought Notice is for information and planning purposes only, at this time, and shall not be construed as a solicitation or obligation on the part of the USAMRDC. This SSN is not expected to be a Request for Proposal or Invitation for Bid, nor does it restrict the Government to an ultimate acquisition approach. This notice is for information and planning purposes only, and is not to be construed as a commitment by the Government. The Government will not pay for solicited information. At this time, no solicitation exists; therefore, please do not request a copy of the solicitation. NO PHONE CALLS PLEASE. If a solicitation is released, a synopsis will be posted on the Government Point of Entry at https://sam.gov/. It is the responsibility of any potential vendor to monitor SAM.gov for the release of any solicitation or synopsis.

8. Background: The USAMMDA's mission is to develop and manage medical materiel to protect and sustain the WaSSNghter 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. 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). A Freeze Dried Plasma (FDP) product would reduce wastage due to breakage and expiration, and 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.

9. Objective and Purpose: USAMMDA is seeking to procure either a Food and Drug Administration (FDA) licensed Freeze Dried Plasma product or a Freeze Dried Plasma product that has a current Emergency Use Authorization (EUA) from the FDA. USAMMDA is seeking potential industry partners who have a FDP product at this stage of development.

10. Information Requested in Capability Statement:

· Describe the company’s Freeze Dried Plasma technology and whether the product is FDA licensed or has a current Emergency Use Authorization.

11. North American Industry Classification System (NAICS) Code: The NAICS code for this potential action is 541715 (Research and Development in the Physical Engineering and Life Sciences, except Nanotechnology and Biotechnology) with a Size Standard of 1,000 employees.

12. Response Due Date: Interested parties should submit the attached SSN response electronically by 3:00 pm EDT 24 August 2024 via e-mail to Timothy Kelly at timothy.j.kelly169.civ@health.mil.

13. Instructions to Responders:

13.1 The Government appreciates responses from all capable and qualified sources.

13.2 The subject header of the e-mail for submission of the SSN response shall be: W81XWH-24-SSN-TJK2 Freeze Dried Plasma SSN.

13.3 Interested firms should submit a response (Capability Statement) that demonstrates the Offeror’s capabilities identified in this SSN. The Capability Statement shall not exceed five (5) typed pages; additional sheets for cover page, table of contents, tables, and charts will not be counted toward page limitation.

13.3.1

a. Cover Page (1 page)

b. Current Technical Expertise, Knowledge, and Management Capability

c. Brief summary of relevant experience pertaining to the requirement (for example: government, academia, or industry experience).

d. List of citations and other relevant documents describing experience and past performance

13.4 Fill in the below table when responding to this Sources Sought.

SSN Number

Company Name

Company Address

Point of Contact

Phone Number

E-mail Address

Tax Identification Number (TIN)

Cage Code

DUNS

Company Web Page

Company Location(s)

Company is / is not a Small Business

Company is / is not SAM Registered

Other Classifications (e.g. 8(a), HubZone, Woman-Owned, Veteran-Owned, Service-Disabled Veteran-Owned)

If 8(a), date that the company graduates from the program.

14. Disclaimer and Important Notes: The purpose of this SSN notice is to gain market knowledge. The Government is not obliged to award a contract or otherwise pay for the information provided in the responses received. 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 responses are complete and sufficiently detailed to allow the Government to determine the organization's solution. Responders are advised that the Government is under no obligation to acknowledge receipt of the information received, or to provide feedback to respondents regarding any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published on SAM.gov. Responses to this notice will not be considered adequate responses to a solicitation.

15. Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in submitted responses. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).

Original Point of Contact (POC): Timothy Kelly, timothy.j.kelly169.civ@health.mil