Opportunity Information: Apply for W81XWH 20 S CRRP
The DoD Combat Readiness, Rapid Development and Translational Research Award (RDTRA) is a funding opportunity under the Combat Readiness Requirements Program (CRRP) that focuses on improving trauma care and medical readiness in the kinds of environments where military medicine is most stressed: combat operations, austere settings with limited supplies, prolonged field care, en route care, and mass casualty situations. The central aim is practical impact at the point of greatest need, meaning solutions that can help save lives when evacuation is delayed, equipment is constrained, and care may be delivered by providers with varying levels of training under unpredictable environmental conditions.
This award is designed specifically to speed up translation, moving strong ideas and promising early findings into real-world clinical applications. The program emphasizes rapid advancement or an innovative "leap ahead" rather than slow, incremental progress. Funded work should be positioned to accelerate the development of healthcare products, technologies, and/or practice guidelines that can realistically transition toward clinical or operational use. While the military setting is the priority, the opportunity also recognizes that military and civilian trauma care influence each other, so proposals that mainly advance civilian trauma care are still eligible as long as the work remains relevant to service members, Veterans, military beneficiaries, and/or the broader American public.
A notable feature of the RDTRA mechanism is the encouragement to "leverage" existing translational research resources. In this context, leveraging means building on tools, platforms, datasets, prior studies, established models, or other existing capabilities so the project can amplify knowledge gains and/or reach higher technical maturity faster than it could from a standing start. The opportunity explicitly welcomes knowledge products (knowledge resulting from research that can improve individual or public health) and other solutions that shorten the path for military-relevant medical products or technologies to reach clinical and operational settings.
In terms of allowable research, the award supports translational and advanced preclinical work, including animal studies, when there is substantial preliminary or published evidence that strongly supports a clear route to clinical translation. Research involving human subjects, human anatomical substances, or human cadavers is permitted, but clinical trials are not allowed. The opportunity uses a standard definition of a clinical trial: any study where human subjects are prospectively assigned to an intervention (including placebo or control conditions) to evaluate effects on biomedical or behavioral health outcomes. In other words, human-focused research can be included, but not in a way that constitutes a prospective interventional trial designed to test outcomes.
The funding and scale are set up for a small number of relatively substantial awards. For FY20, the program anticipated a total program allocation of about $8.0 million to fund roughly four awards. Individual applications were expected to request no more than $2.0 million in total costs for the full period of performance. Awards were expected to be made by September 30, 2021, and were anticipated to use FY20 funds that would remain available for use until September 30, 2026, reflecting the time-limited nature of federal fiscal-year appropriations.
From an administrative and contracting standpoint, the Department of Defense (through the U.S. Army Medical Research Acquisition Activity, supporting the USAMRDC extramural program) may issue either a grant or a cooperative agreement for selected projects. Which instrument is used depends on how much involvement the government expects to have during the research. If no substantial government involvement is anticipated, the award is typically a grant; if substantial involvement is anticipated (such as collaboration, active participation, or intervention in the work), the award is typically a cooperative agreement. The final instrument type and start date are determined during negotiations, and funding depends on federal fund availability and the results of scientific and programmatic review (merit, quality, and fit with government requirements). The announcement also clarifies that this mechanism is not intended to support fundamental basic research, defined here as work aimed at understanding phenomena without a specific application toward a product, process, or practical use.
Regulatory requirements are emphasized for projects involving FDA-regulated products and for any work involving humans or human materials. If the proposed study uses an investigational drug or biologic not approved by the FDA for the intended use, the award requires evidence that an Investigational New Drug (IND) application has been or will be submitted to the FDA within 60 days of the DoD award. Similarly, investigational devices require evidence of an Investigational Device Exemption (IDE) submission within 60 days. The government reserves the right to withdraw funding if these submissions are not made on time or if documented IND/IDE status is not obtained within 12 months of the award date. For human subjects, human anatomical substances, or human cadavers, DoD-funded work must undergo review by the USAMRDC Office of Research Protections, Human Research Protection Office (HRPO), in addition to any local IRB or ethics review. Local IRB approval is not required at the time of application submission, but applicants are advised to plan for HRPO review timelines, typically at least two to three months. Multi-institution projects must also provide a plan for single-IRB arrangements and identify the lead institution responsible for the master protocol and consent materials as the primary regulatory point of contact.
Key opportunity details from the notice include the funding opportunity number W81XWH-20-S-CRRP, administration by the Department of Defense (Department of the Army, USAMRAA), a discretionary R&D activity category (CFDA 12.420), broad eligibility described as unrestricted in the listing, an original application closing date of December 3, 2020, and an expectation of approximately four awards under this specific RDTRA mechanism.Apply for W81XWH 20 S CRRP
- The Department of Defense, Dept. of the Army -- USAMRAA in the science and technology and other research and development sector is offering a public funding opportunity titled "DoD Combat Readiness, Rapid Development and Translational Research Award" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 12.420.
- This funding opportunity was created on Jul 24, 2020.
- Applicants must submit their applications by Dec 03, 2020. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The number of recipients for this funding is limited to 4 candidate(s).
- Eligible applicants include: Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled Additional Information on Eligibility.
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FAQs: DoD Combat Readiness, Rapid Development and Translational Research Award (RDTRA)
What is the RDTRA award?
The DoD Combat Readiness, Rapid Development and Translational Research Award (RDTRA) is a funding opportunity under the Combat Readiness Requirements Program (CRRP) focused on improving trauma care and medical readiness in high-stress military medical environments, including combat operations, austere settings, prolonged field care, en route care, and mass casualty situations.
What is the main goal of this funding opportunity?
The central aim is practical impact where need is greatest: solutions that can save lives when evacuation is delayed, supplies and equipment are constrained, and care is delivered under unpredictable conditions by providers with varying levels of training.
What kinds of operational settings does the program prioritize?
The program prioritizes military medicine in demanding environments such as combat operations, austere and resource-limited settings, prolonged field care scenarios, en route care, and mass casualty events.
Is the program focused on research or real-world application?
It is specifically designed to speed up translation, moving strong ideas and early findings toward real-world clinical or operational applications. The emphasis is on rapid advancement or an innovative "leap ahead" rather than slow, incremental progress.
What types of outputs or deliverables are encouraged?
Funded projects should be positioned to accelerate development of healthcare products, technologies, and/or practice guidelines that can realistically transition toward clinical or operational use. The opportunity also explicitly welcomes knowledge products that can improve individual or public health and shorten the path to deployment of military-relevant medical products or technologies.
Can a project be primarily focused on civilian trauma care?
Yes. Proposals that mainly advance civilian trauma care are still eligible as long as the work remains relevant to service members, Veterans, military beneficiaries, and/or the broader American public.
What does it mean to "leverage" existing translational research resources?
Leveraging means building on existing tools, platforms, datasets, prior studies, established models, or other capabilities so the project can amplify knowledge gains and/or reach higher technical maturity faster than it could starting from scratch.
What kinds of research are allowable under RDTRA?
The award supports translational and advanced preclinical work, including animal studies, when there is substantial preliminary or published evidence supporting a clear route to clinical translation. Research involving human subjects, human anatomical substances, or human cadavers is permitted, but clinical trials are not allowed.
Are animal studies allowed?
Yes. Animal studies are supported as part of translational and advanced preclinical work, provided there is substantial preliminary or published evidence that supports a clear path to clinical translation.
Is human subjects research allowed?
Yes. Research involving human subjects, human anatomical substances, or human cadavers is permitted, as long as the work does not meet the definition of a clinical trial under this opportunity.
Are clinical trials allowed under this award?
No. Clinical trials are not allowed under this funding opportunity.
How does the opportunity define a clinical trial?
A clinical trial is defined as any study in which human subjects are prospectively assigned to an intervention (including placebo or control conditions) to evaluate effects on biomedical or behavioral health outcomes.
Can a project include human-focused research without being a clinical trial?
Yes. Human-focused research can be included, but not in a way that constitutes a prospective interventional trial designed to test outcomes (as defined by the opportunity).
What is the expected total program funding and number of awards?
For FY20, the program anticipated a total allocation of about $8.0 million to fund roughly four awards under this mechanism.
What is the maximum budget per application?
Individual applications were expected to request no more than $2.0 million in total costs for the full period of performance.
When were awards expected to be made?
Awards were expected to be made by September 30, 2021.
What federal funds support these awards, and how long are they available?
Awards were anticipated to use FY20 funds that would remain available for use until September 30, 2026, reflecting the time-limited nature of federal fiscal-year appropriations.
What awarding instruments might the DoD use (grant vs cooperative agreement)?
The DoD may issue either a grant or a cooperative agreement. The choice depends on expected government involvement during the research: a grant is typical when no substantial government involvement is anticipated, while a cooperative agreement is typical when substantial involvement (such as collaboration, active participation, or intervention) is anticipated.
Is the instrument type decided at application submission?
No. The final instrument type (grant or cooperative agreement) and the start date are determined during negotiations.
Is funding guaranteed if an application is selected?
Funding depends on federal fund availability and the results of scientific and programmatic review, including merit, quality, and fit with government requirements.
Is fundamental basic research supported by this mechanism?
No. This mechanism is not intended to support fundamental basic research, defined in the notice as work aimed at understanding phenomena without a specific application toward a product, process, or practical use.
What regulatory requirements apply to FDA-regulated products?
Regulatory requirements are emphasized for projects involving FDA-regulated products. If the study uses an investigational drug or biologic not approved by the FDA for the intended use, evidence is required that an IND has been or will be submitted to the FDA within 60 days of the DoD award. For investigational devices, evidence is required that an IDE has been or will be submitted within 60 days.
What happens if IND/IDE submissions are not made on time?
The government reserves the right to withdraw funding if IND/IDE submissions are not made within the required timelines or if documented IND/IDE status is not obtained within 12 months of the award date.
What oversight applies to projects involving human subjects or human materials?
For research involving human subjects, human anatomical substances, or human cadavers, DoD-funded work must be reviewed by the USAMRDC Office of Research Protections, Human Research Protection Office (HRPO), in addition to any local IRB or ethics review.
Is local IRB approval required at the time of application?
No. Local IRB approval is not required at the time of application submission.
How long should applicants plan for HRPO review?
Applicants are advised to plan for HRPO review timelines, typically at least two to three months.
What is required for multi-institution projects regarding IRB review?
Multi-institution projects must provide a plan for single-IRB arrangements and identify the lead institution responsible for the master protocol and consent materials as the primary regulatory point of contact.
What is the funding opportunity number for this RDTRA announcement?
The funding opportunity number listed is W81XWH-20-S-CRRP.
Which agency administers this opportunity?
The opportunity is administered by the Department of Defense (Department of the Army) through the U.S. Army Medical Research Acquisition Activity (USAMRAA), supporting the USAMRDC extramural program.
What is the CFDA number and activity type mentioned in the notice?
The notice lists CFDA 12.420 and describes the activity category as discretionary R&D.
Who is eligible to apply?
The eligibility in the listing is described as unrestricted.
What was the original application closing date?
The original application closing date stated in the notice was December 3, 2020.
About how many awards were expected under this specific RDTRA mechanism?
The notice indicated an expectation of approximately four awards under this RDTRA mechanism.
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