2024-04-18 Oxygen Carrier Request For Information-Posting.docx

REQUEST FOR INFORMATION

REQUEST FOR INFORMATION (RFI) NO. : HT9425-24-CB7-JD01

1.0 RFI TITLE: Oxygen Carrier for Use in Treatment of Canine Hemorrhagic Shock

2.0 AGENCY: U.S. Army Medical Materiel Development Activity (USAMMDA)

3.0 OFFICE: Warfighter Protection and Acute Care Project Management Office (WPAC)

4.0 LOCATION: Fort Detrick, MD

5.0 SUBJECT: The WPAC of the USAMMDA is conducting market research to determine whether a commercial solution can be provided to meet requirements for development, within the context of U.S. FDA regulations, of an Oxygen Carrier for Use in Treatment of Canine Hemorrhagic Shock. It is estimated that the annual military procurement requirement for a canine oxygen carrier is 700 treatments. This market research may also assist with the further development and/or refinement of the requirements.

6.0 DISCLAIMER: 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 USAMRDC, or collaborative Department of Defense (DoD) activities. Neither unsolicited proposals nor any other kind of offers 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.

7.0 DESCRIPTION: WPAC of the USAMMDA has a requirement for development of an oxygen carrier that would be useful for immediate treatment of hemorrhagic shock in canines. WPAC believes that the oxygen carrier should have the following desired characteristics:

(1) Its administration will increase the probability of survival.

(2) Its administration will reduce the need for other treatment products.

(3) It will be amenable to administration immediately after injury, most likely along with blood components such as plasma or platelets. Thus, a packaged product that requires lengthy preparation for administration is not desirable. An upper limit of six (6) minutes for preparation time is under consideration.

(4) It will be amenable to military use in an austere environment, as distinguished from a veterinary hospital.

(5) It will be packaged in a low volume (250 milliliters or less) to minimize the burden of transporting it and storing it.

(6) It will be stable (retain its effectiveness) for at least one year over a broad temperature range, such as -20 degrees Celsius to 40 degrees Celsius.

(7) It will be amenable to administration by at least one of several routes, such as oral, intravenous, intraosseous, and intramuscular.

8.0 SUBMISSION INSTRUCTIONS: Entities interested in submitting a response must furnish a CAPABILITIES STATEMENT. The subject header of the email for submission of questions and/or the RFI response shall be: “REQUEST FOR INFORMATION (RFI) NO.: HT9425-24-CB7-JD01Oxygen Carrier for Use in Treatment of Canine Hemorrhagic Shock.” All information regarding capabilities statements or any other proprietary information relative to this RFI shall be marked appropriately. Electronic files shall not exceed 20MB. All submissions become Government property and will not be returned. Submission should include the following information:

8.1 CAPABILITIES STATEMENT: The Capabilities Statement should address the following topics:

a. Provide technical information about one or more candidates that has the desired characteristics (the 7 characteristics identified in Section 7.0). The requested technical information about candidates is as follows:

· identity / designation;

· basic chemical information (Chemical Abstracts Service Number if available);

· evidence of possible efficacy from in silico, in vitro, or in vivo analysis;

· mechanism of action, as theorized or known;

· evidence of safety.

b. For each candidate, provide the following information:

· status and ownership of intellectual property;

· FDA regulatory rights;

· business arrangements already made for product development;

· business arrangements under consideration to support product development;

· any past or present connections to U.S. government organizations, programs, or personnel;

· any other information that may be relevant in a business sense to product development.

c. Assessment of the candidate’s Technology Readiness Level (TRL), based on the attached TRL definitions (Attachment 1). For each major activity (abbreviated M, S, E, or R), state the level attained (5, 6, 7, or 8). If level 5 has not been attained, state it as “Pre-5.” It is recognized that, for any given candidate, there may be varying levels of maturity for the major activities.

d. Discuss the ability to, or potential ability to, have the desired characteristics (the 7 characteristics identified in Section 7.0). Address each of the 7 characteristics. If a desired characteristic is thought to be unattainable or irrelevant to intended use, explain why.

e. Present a summary of the regulatory pathway to FDA approval of the technology, including anticipated clinical and laboratory studies necessary to achieve marketing approval.

f. Present a high-level commercialization strategy.

g. Present a project timeline for performance of major activities that relate to research, development, testing and regulatory approval.

h. Present a rough order of magnitude (ROM) for the total estimated cost for research, development, testing and FDA approval.

For topics g and h, respondents may find it useful to provide schedule and cost estimates for product development in the form of a table, wherein the schedule for major activities is presented in years and costs are stated in millions (M) of U.S. dollars.

9.0 SUBMISSION CONTACT INFORMATION: Interested entities shall forward submissions to Jamie Diggs at jamie.l.diggs.civ@health.mil no later than the close of business May 20, 2024. Telephonic communication will not be considered as submission nor receive response.

Only electronic responses are requested. No evaluation letters and/or results will be issued to the respondents. 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 offeror to monitor this site for the release of any solicitation or synopsis. Telephonic communication will not be considered as submission nor receive response.

Responses shall be limited to thirty (30) pages. Please address all topics described in Section 8. All submissions become Government property and will not be returned.

10.0 REQUIRED INFORMATION: Fill in the below table when responding to this RFI.

RFI Number

Company Name

Company Address

Point of Contact

Phone Number

E-mail Address

Tax Identification Number (TIN)

CAGE Code

DUNS Number

Company Web Page

Company Location(s)

Company is / is not a Small Business

Company is / is not SAM Registered

Other Socio-Economic Classifications (e.g. 8(a), HUB Zone, Woman-Owned, Veteran-Owned, Service- Disabled Veteran-Owned)

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

Attachment 1

TECHNOLOGY READINESS LEVELS FOR CERTAIN CANINE VETERINARY MEDICAL PRODUCTS