Request-for-Information-Pivotal-Novel-Countermeasure.docx

Request for Information (RFI)

1. RFI Number: HT9425-24-RFI-EMZ02

2. RFI Title: Pivotal Novel Countermeasure

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

4. Office: U.S. Air Force 59th Medical Wing, Science and Technology Office

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

6. Location: Joint Base San Antonio – Lackland Air Force Base

7. Background: The USAF 59th Medical Wing, Science and Technology Office has a requirement for research and development services. This research study Is titled “Pivotal validation of a novel countermeasure to improve recovery following traumatic brain injury (TBI) combined with hemorrhagic shock in prolonged field care, delayed evacuation, or remote settings before evacuation”.

8. Objectives:

The main objectives are summarized as follows:

· To determine whether intravenous (IV) administration of tatM2NX after TBI will improve neurological severity score (NSS), memory function, reduce neuronal cell death and TBI-related biomarkers post insult.

· Assess pharmacokinetics in an uninjured large swine model and general safety outcome data (blood chemistry, renal and hepatic function).

9. Information Requested in Capability Statement:

· Confirm ability to conduct research in a manor that will meet the objectives listed above.

10. North American Industry Classification System (NAICS) Code: The NAICS code for this potential action is: 541714 Research and Development in Biotechnology (Except Nanobiotechnology)

11. Response Due Date: Interested parties should submit their RFI response electronically by 12:00 pm Eastern on 18 April 2024 via e-mail to Mr. Eric Zampelli at eric.m.zampelli.civ@healt.mil.

12. Instructions to Responders:

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

12.2 The Government welcomes input and will accept questions pertaining to this RFI; however, the Government reserves the right to answer or not answer all questions pertaining to this RFI. Only one set of questions per vendor will be accepted. Telephone requests will not be entertained.

12.3 The subject header of the e-mail for submission of questions and/or the RFI response shall be: HT9425-24-RFI-EMZ02.

12.4 Interested firms should submit a response (Capability Statement) that demonstrates the Offeror’s capabilities identified in this RFI. 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.

12.5 Fill in the below table when responding to this Sources Sought / RFI.

RFI 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.

13. Disclaimer and Important Notes:

In accordance with Federal Acquisition Regulation (FAR) 15.201, "Exchange with industry before receipt of proposals," and FAR 52.215-3, "Request for information (RFI) or Solicitation for Planning Purposes (SFP)," this RFI 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. The purpose of this RFI notice is to gain market knowledge. This RFI is not expected to be a Request for Proposal or Invitation for Bid, nor does it restrict the Government to an ultimate acquisition approach. 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. At this time, no solicitation exists; therefore, please do not request a copy of the solicitation. NO PHONE CALLS PLEASE. It is the responsibility of any potential vendor to monitor SAM.gov for the release of any solicitation or synopsis. Responses to this notice will not be considered adequate responses to a solicitation.

14. 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): Eric Zampelli; eric.m.zampelli.civ@health.mil