Defense Medical Research and Development Program – En Route Care Award

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Funding Opportunity ID: 331679
Opportunity Number: W81XWH-21-DMRDP-ERCA
Opportunity Title: Defense Medical Research and Development Program – En Route Care 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: Feb 22, 2021
Close Date: Jun 23, 2021
Last Updated Date: Feb 22, 2021
Award Ceiling: $0
Award Floor: $0
Estimated Total Program Funding: $5,400,000
Expected Number of Awards: 4
Description: The intent of this award mechanism is to support development of highly innovative materiel and knowledge products to drive critical combat casualty care capabilities to the Warfighter in highly mobile, austere, and extreme environments where evacuation capabilities may be significantly delayed or unavailable.(Ref. 2, above) This Funding Opportunity aligns with the recently published Committee on En Route Combat Casualty Care (CoERCCC) top 10 research priorities including: medical documentation, clinical decision support, patient monitoring, transfer of care, transport physiology, maintenance of normothermia, transport timing, intelligent tasking, commanders’ decision support, and unmanned transport,(Ref. 14, above) and focuses on research to knowledge and materiel to improve the en route care and patient movement from point of injury to definitive care by ground, air, and sea.The solutions under this Funding Opportunity will not be limited to military use. Knowledge and materiel products developed will have applications in civilian environments as well. Natural disasters, explosive events, accidents, and mass shootings can generate a surge of casualties and complex injuries that can mirror those seen on the battlefield. Additionally, civilians, particularly those in rural areas, face challenges with delayed access to hospital-based care. While only 20% of all Americans live in rural areas, they account for more than 50% of all trauma-related fatalities. The majority of these individuals do not live within an hour of a Level I or II trauma center and could benefit from improvements in ERC. Solutions generated by this work will be applicable in civilian settings where mode of patient movement, environmental conditions, or traumatic condition are similar to the military use case.We anticipate that projects funded under this award mechanism, as systematic application of knowledge or understanding, directed toward the production of useful materials, devices, and systems or methods, including design, development, and improvement of prototypes and new processes to meet specific requirements, will increase survivability from both combat-related and trauma-induced injuries.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 ofthe 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.The anticipated total costs budgeted for the entire period of performance for an FY21 DMRDP JPC-6/CCCRP ERCA will not exceed $1.4 million (M). 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 CDMRP expects to allot approximately $1.8M of the FY21, $1.8M of the FY22, and $1.8M of the FY23 DHP RDT&E appropriations to fund approximately three or four (3 or 4) FY21 DMRDP JPC_6/CCCRP ERC 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, FY22, and FY23 funds, which will expire for use on September 30, 2027, September 30, 2028, and September 30, 2029, respectively.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 U.S. Army Medical Research and Development Command (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.This Funding Opportunity may support applied or clinical research; 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.Clinical Research is defined as: (1) Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, and (d) development of new technologies; (2) Epidemiologic and behavioral studies; and (3) Outcomes research and health services research. Note: Studies that meet the requirements for IRB Exemption 4 are not considered CDMRP-defined clinical research. IRB Exemption 4 refers to research involving the collection or study of existing de-identified specimens or data, if these sources are publicly available.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.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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