DoD Combat Readiness, Rapid Development and Translational Research Award

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Funding Opportunity ID: 328340
Opportunity Number: W81XWH-20-S-CRRP
Opportunity Title: DoD Combat Readiness, Rapid Development and Translational Research 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: Jul 24, 2020
Close Date: Dec 03, 2020
Last Updated Date: Jul 24, 2020
Award Ceiling: $0
Award Floor: $0
Estimated Total Program Funding: $8,000,000
Expected Number of Awards: 4
Description: The CRRP seeks to enhance medical capabilities and Force readiness at the point of greatestneed in order to save the most lives in trauma care scenarios, which may be complicated bycombat operations, limited resources, austere conditions, and/or mass casualty events. The intent of the FY20 CRRP RDTRA is to support research that will accelerate the movement of promising ideas into clinical applications, including healthcare products, technologies, and/or practice guidelines. Research under this award mechanism should represent a rapidadvancement or innovative “leap ahead” and have the potential for broadly applicable, cross- cutting advances benefiting military health and medicine as well as the general public.Applicants may leverage existing resources in translational research to address high-impact research ideas or unmet needs to enable the delivery of life-saving care to the Warfighter during prolonged and en route care in austere and combat environments. Research of interest mayinclude knowledge products, “knowledge resulting from research with the potential to improve individual or public health,”2 and solutions that can accelerate the introduction of military- relevant health products or technologies into clinical and/or operational use. For this awardmechanism, the definition of “leveraging” is as follows: An investigator basing a research project on existing resources in order to amplify potential gains in knowledge or accelerate technical maturity. Projects should consider the varied expertise levels of the medical providers, available resources, and the possible diverse environmental conditions in combat situations.Proposal/application submissions are encouraged to include characteristics relevant to military use in non-hospital settings in theater, but submissions that propose solutions to advance civiliantrauma care are not precluded, since civilian trauma and trauma care in the military are mutually influential, and may be co-occurring in certain situations.Preclinical research, including animal studies, that is already supported by substantial preliminary or published data and strongly validates clinical translation is appropriate for this award mechanism.Research involving human subjects and human anatomical substances is permitted; 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.The proposed research must be relevant to active duty Service members, Veterans, military beneficiaries, and/or the American public.The anticipated total costs budgeted for the entire period of performance for an FY20 CRRP RDTRA will not exceed $2M. Refer to Section II.D.5, Funding Restrictions, for detailed funding information.Awards will be made no later than September 30, 2021. For additional information refer to Section II.F.1, Federal Award Notices.The CDMRP expects to allot approximately $8.0M to fund approximately 4 RDTRA proposals/applications. Funding of proposals/applications received is contingent upon the availability of Federal funds for this program as well as the number of proposals/applications received, the quality and merit of the proposals/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 FY20 funding opportunity will be funded with FY20 funds, which will expire for use onSeptember 30, 2026.The USAMRDC executes its extramural research program primarily through the awarding of contracts and assistance agreements (grants and cooperative agreements). The type of instrument used to reflect the business relationship between the organization and the Government is at the discretion of the Government, in accordance with the Federal Grant and Cooperative Agreement Act of 1977, as amended, 31 USC 6301-6308, which provides the legal criteria to select a procurement contract or an assistance agreement. An assistance agreement (grant or cooperative 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. If “no substantial involvement” on the part of the fundingagency is anticipated, a grant award will be made (31 USC 6304).Conversely, if substantial involvement on the part of the funding agency is anticipated, acooperative agreement will be made (31 USC 6305) and the award will identify the specific substantial involvement. Substantial involvement may include collaboration, participation, or intervention in the research to be performed under the award.A contract is required when the principal purpose of the instrument is to acquire property or services for the direct benefit or use of the U.S. Government.The award type, along with the start date, will be determined during the negotiation process. Please see Appendix 2, Section E, of the General Submission Instructions for more information.This BAA may not be used to support fundamental basic research: For this BAA, basic research is defined as research directed toward greater knowledge or understanding of the fundamental aspects of phenomena and of observable facts without specific applications toward process or products in mind.Research Involving a U.S. Food and Drug Administration (FDA)-Regulated Drug, Biologic, or Device: If the study proposed involves the use of a drug or biologic that has not been approved by the FDA for the proposed investigational use, evidence is required that an Investigational New Drug (IND) application that meets all requirements under the Code of Federal Regulations, Title 21, Part 312 (21 CFR 312) has been submitted or will be submitted to the FDA within 60 days of award. If the investigational product is a device, evidence is required that an Investigational Device Exemption (IDE) application, that meets all requirements under 21 CFR 812, has been submitted or will be submitted to the FDA within 60 days of award. The Government reserves the right to withdraw funding if the IND or IDE application has not been submitted to the FDA within 60 days of the DoD award date or if the documented application status of the IND or IDE has not been obtained within 12 months of the award date.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 Submission 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 regulatorysubmissions and requirements.
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