DoD Defense Medical, Battlefield Resuscitation for Immediate Stabilization of Combat Casualties Award

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Funding Opportunity ID: 330524
Opportunity Number: W81XWH-21-DMRDP-BRISCC
Opportunity Title: DoD Defense Medical, Battlefield Resuscitation for Immediate Stabilization of Combat Casualties Award
Opportunity Category: Discretionary
Opportunity Category Explanation:
Funding Instrument Type: Cooperative Agreement
Grant
Category of Funding Activity: Science and Technology and other Research and Development
Category Explanation:
CFDA Number(s): 12.420
Eligible Applicants: Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled “Additional Information on Eligibility”
Additional Information on Eligibility:
Agency Code: DOD-AMRAA
Agency Name: Department of Defense
Dept. of the Army — USAMRAA
Posted Date: Dec 21, 2020
Close Date: Apr 07, 2021
Last Updated Date: Dec 21, 2020
Award Ceiling: $0
Award Floor: $0
Estimated Total Program Funding: $16,700,000
Expected Number of Awards: 21
Description: The intent of this Program Announcement is to support the early development of high-impact materiel products and new ways, methods, or modifications to existing trauma practice (i.e., knowledge products3) for future multi-domain operations (MDO) where evacuation capabilities may be significantly delayed or unavailable. Projects should consider the varied expertise levels of the medical providers and the possible diverse environmental conditions. A focus is on enhancing capabilities at the point of greatest need, including life-saving interventions to be rendered immediately post-injury, during periods of prolonged care in-theater. Medical materiel solutions are encouraged to include characteristics relevant to military use in austere, combat environments. Characteristics and concepts to consider include but are not limited to:• Low-weight and low-cube: Compared to existing materiel products, the product is a smaller size and weight to aid in portability and storage.• Low-power, longer shelf life: The product has reduced power usage requirements and longer shelf life than currently available products.• Modularity and interoperability: The materiel product is compatible with and easily added to existing technologies, equipment, or platforms being used by the military.• Ruggedization: The materiel product is able to withstand harsh and varied environments such as extreme temperature fluctuations, vibration, and high altitude while maintaining operability and stability.• Low-complexity, decision-supported, closed or semi-closed loop feedback or automation: The product is simple to operate, provides decision support to user, and can be partially or fully autonomous. The product can be used by various levels of medical providers with minimal training.• Affordability: The materiel and knowledge products would result in cost-savings over what is currently available and considers the costs of maintaining and sustaining the product.The proposed research must be relevant to Service members. It is also expected that outcomes of funded research will benefit Veterans, military beneficiaries, and the American public.The types of awards made under the Program Announcement will be assistance agreements. An assistance agreement is appropriate when the Federal Government transfers a “thing of value” to a “state, local government,” or “other recipient” to carry out a public purpose of support or stimulation authorized by a law of the United States instead of acquiring property or service for the direct benefit and use of the U.S. Government. An assistance agreement can take the form of a grant or cooperative agreement. The level of involvement on the part of the DoD during project performance is the key factor in determining whether to award a grant or cooperative agreement. If “no substantial involvement” on the part of the funding agency is anticipated, a grant award will be made (31 USC 6304). Conversely, if substantial involvement on the part of the funding agency is anticipated, a cooperative agreement will be made (31 USC 6305), and the award will identify the specific substantial involvement. Substantial involvement may include, but is not limited to, collaboration, participation, or intervention in the research to be performed under the award. The award type, along with the start date, will be determined during the negotiation process.Research Scope: The FY21 DMRDP JPC-6/CCCRP BRISCC Award is structured with three different funding levels based on the scope of the research proposed. It is the responsibility of the Principal Investigator (PI) to select the funding level that is most appropriate for the proposed research project. The Government reserves the right to fund an application at a lower funding level.• Funding Level 1: Innovative, high-risk/high-reward research that is in the early stages of idea development or is an untested theory that addresses an important problem. Preliminary data are not required.• Funding Level 2: Preclinical and clinical research that is supported by substantial preliminary or published data. Clinical trials are not allowed under this funding opportunity.• Funding Level 3: Advanced preclinical and clinical research supported by substantial preliminary or published data that require additional financial resources due to maturity of the research proposed. Clinical trials are not allowed under this funding opportunity.The anticipated total costs budgeted for the entire period of performance for an FY21 DMRDP BRISCC Award Funding Level 1 will not exceed $800,000. The anticipated total costs budgeted for the entire period of performance for an FY21 DMRDP BRISCC Award Funding Level 2 will not exceed $1.25 million (M). The anticipated total costs budgeted for the entire $2.0M. Refer to Section II.D.5, Funding Restrictions, for detailed funding information.Awards will be made no later than September 30, 2022. For additional information refer to Section II.F.1, Federal Award Notices.The JPC-6/CCCRP expects to allot approximately $4.7M of FY21, $5.5M of FY22, and $6.5M of FY23 DHP RDT&E appropriations to fund approximately 8 to 21 FY21 DMRDP BRISCC Award applications. Funding of applications received is contingent upon the availability of Federal funds for this program as well as the number of applications received, the quality and merit of the applications as evaluated by scientific and programmatic review, and the requirements of the Government. Funds to be obligated on any award resulting from this funding opportunity will be available for use for a limited time period based on the fiscal year of the funds. It is anticipated that awards made from this FY21 funding opportunity will be funded with FY21 funds, which will expire for use on September 30, 2027; FY22 funds, which will expire for use on September 30, 2028; and FY23 funds, which will expire for use on September 30, 2029. As of the release date of this Program Announcement, the FY21 Defense Appropriations Bill has not been passed and there is no guarantee that any additional funds will be made available to support this program. The funding estimated for this Program Announcement is approximate and subject to realignment. Funding of applications received in response to this Program Announcement is contingent upon the availability of Federal funds for this program.This Program Announcement may support basic, applied, preclinical, and clinical research involving human subjects and human anatomical substances; however clinical trials are not allowed under this funding opportunity. A clinical trial is defined as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.Research Involving Human Anatomical Substances, Human Subjects, or Human Cadavers: All DoD-funded research involving new and ongoing research with human anatomical substances, human subjects, or human cadavers must be reviewed and approved by the USAMRDC Office of Research Protections (ORP), Human Research Protection Office (HRPO), prior to research implementation. This administrative review requirement is in addition to the local Institutional Review Board (IRB) or Ethics Committee (EC) review. Local IRB/EC approval at the time of submission is not required. Allow a minimum of 2 to 3 months for HRPO regulatory review and approval processes. Refer to the General Application Instructions, Appendix 1, and the Human Subject Resource Document available on the electronic Biomedical Research Application Portal (eBRAP) “Funding Opportunities & Forms” web page (https://ebrap.org/eBRAP/public/Program.htm) for additional information.If the proposed research is cooperative (i.e., involving more than one institution), a written plan for single IRB review arrangements must be provided at the time of application submission or award negotiation. The lead institution responsible for developing the master protocol and master consent form should be identified and should be the single point of contact for regulatory submissions and requirements.Use of DoD or Department of Veterans Affairs (VA) Resources: If the proposed research involves access to active duty military patient populations and/or DoD or VA resources or databases, the application must describe the access at the time of submission and include a plan for maintaining access as needed throughout the proposed research. Refer to Section II.D.2.b.ii, Full Application Submission Components, for detailed information. Refer to the General Application Instructions, Appendix 1, for additional information.Recruitment Milestones: For research involving human subject enrollment, the proposal/application must indicate the quarterly enrollment targets across all sites in Attachment 5: Statement of Work. Successful applicants will work with USAMRAA to establish milestones for human subject recruitment. Continued support for the project will be based upon satisfactory progress in meeting the established milestones.Rigor of Experimental Design: All projects should adhere to accepted standards for rigorous study design and reporting to maximize the reproducibility and translational potential of preclinical research. Core standards are described in Landis, S.C., et al., A call for transparent reporting to optimize the predictive value of preclinical research, Nature 2012, 490:187-191 (www.nature.com/nature/journal/v490/n7419/full/nature11556.html). While these standards were written for preclinical studies, the basic principles of randomization, blinding, sample-size estimation, and data handling derive from well-established best practices in research, and should be applied consistently across basic and translational studies. Projects that include research on animal models are required to submit Attachment 8: Animal Research Plan, as part of the proposal/application package to describe how these standards will be addressed. Applicants should consult the ARRIVE (Animal Research: Reporting In Vivo Experiments) guidelines to ensure relevant aspects of rigorous animal research are adequately planned for, and, ultimately, reported. The ARRIVE guidelines can be found at https://www.elsevier.com/__data/promis_misc/622936arrive_guidelines.pdf.Research Involving Animals: All DoD-funded research involving new and ongoing research with animals must be reviewed and approved by the USAMRDC ORP Animal Care and Use Review Office (ACURO), in addition to the local Institutional Animal Care and Use Committee (IACUC) of record. IACUC approval at the time of submission is not required. Allow at least 3 to 4 months for ACURO regulatory review and approval processes for animal studies. Refer to the General Application Instructions, Appendix 1, for additional information.
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