DoD Combat Readiness, Rapid Development and Translational Research Award | W81XWH 20 S CRRP

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.

• 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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