FINAL_FY18_JWMRP_Pre-Award-RFI.docx

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Award: W81XWH19C0145, Malaria Vaccine Phase III Clinical Trial
Solicitation number
W81XWH-19-RFI-DAM02
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Request for Information (RFI)

1. RFI Number: W81XWH-19-RFI-DAM02

2. Agency: United States Army Medical Research and Materiel Command (USAMRMC)

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

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

5. Location: TBD

6. Synopsis: The Joint Warfighter Medical Research Program (JWMRP) provides an opportunity to advance previously funded DoD or Service medical research and development (R&D) projects that address the medical requirements of the Services. The JWMRP complements and enhances the Defense Health Program by facilitating the further development of promising industry and academic efforts. Each year a broad spectrum of R&D initiatives are considered under the JWMRP. The efforts are aligned to one of the six Joint Program Committee (JPC) scientific domains. These are: Medical Simulation and Information Sciences (JPC-1), Military Infectious Diseases (JPC-2), Military Operational Medicine (JPC-5), Combat Casualty Care (JPC-6), Radiation Health Effects (JPC-7), and Clinical and Rehabilitative Medicine (JPC-8). Through research efforts focused in advanced technology development and product demonstration and validation, the JWMRP offers a pathway to transition maturing medical solutions to the Military Health System (MHS) for the benefit of our Service members and other MHS beneficiaries.

7. Background:

As directed by Congress in the FY2018 Consolidated Appropriations Act, Public Law 115-141, page 207 of the Senate’s Explanatory Statement states that $50M “shall be used to augment and accelerate high priority Department of Defense (DoD) and Service medical requirements and to continue both core and congressionally-directed prior year initiatives that are close to achieving their objectives and yielding a benefit to military medicine. These funds shall not be used for new projects or for basic research, and they shall be awarded at the discretion of the Secretary of Defense following a review of medical research and development gaps, as well as unfinanced medical requirements of the Services.”

8. Objective and Purpose:

The Government is seeking vendors with the capability to achieve the objectives for either of the two separate requirements described below. All respondents must have previously received DoD funding for a project preceding the project discussed in the respondent’s response to this RFI, per the JWMRP Congressional language.

Project #1:

The objective is to conduct a large-scale study to optimize threat related attention training for post-traumatic stress symptoms (PTSS), and to examine the specificity of therapeutic mechanisms and durability of attention bias modification (ABM) and attentional control training (ACT) by developing and testing a mobile application that delivers ABM for people with post-traumatic stress disorder (PTSD) and alcohol-use disorder in a sample of veterans with these disorders..

Project #2:

The objective is to conduct a randomized, double blind, placebo-controlled trial of the safety and protective efficacy of a malaria vaccine. The respondent must complete the following tasks: (1) Manufacture and quality control (QC) release of a malaria vaccine for use in a proposed trial, initiate and conduct stability program testing for this vaccine, and complete regulatory submissions; (2) Finalize the clinical protocol for a clinical trial and obtain relevant ethical and regulatory approvals; (3) Conduct the clinical trial and complete analyses and reports.

9. Information Requested in Capability Statement:

· Brief summary of relevant experience pertaining to the requirements described above (for example government, academia or industry experience).

· Include the award number of the previous DoD award which qualifies the respondent for this program.

10. 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.

11. Response Due Date: Interested parties should submit the attached RFI response electronically by 12:00 pm Eastern 02 April 2019 via e-mail to Doug Medcalf at douglas.a.medcalf.civ@mail.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: W81XWH-19-RFI-DAM02.

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 two (2) typed pages.

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 USAMRMC. 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 in Federal Business Opportunities at https://www.fbo.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 FedBizOpps 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: Doug Medcalf, douglas.a.medcalf.civ@mail.mil

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