Combat Readiness - Rapid Development and Translational Research Award | W81XWH 21 S CRRP

Opportunity Information: Apply for W81XWH 21 S CRRP

The Combat Readiness - Rapid Development and Translational Research Award (RDTRA) is a Department of Defense (DoD) funding opportunity under the Combat Readiness Requirements Program (CRRP) that focuses on quickly improving trauma care capabilities in the kinds of environments where the military has the hardest time delivering care: forward or pre-hospital settings, prolonged field care, and en route care where resources are limited, conditions are austere, and mass casualty situations can occur. The central goal is to improve Force readiness and save lives by accelerating the translation of strong, promising ideas into practical clinical or operational use, such as healthcare products, medical technologies, and practice guidelines. The program is looking for projects that represent a clear, rapid advance or a genuine "leap ahead" rather than incremental progress, and it emphasizes solutions that can have broad value for military medicine while still being relevant to civilian trauma care (since lessons and innovations often flow both ways).

A defining feature of this mechanism is its emphasis on leveraging existing translational resources to move faster and increase the chances of near-term impact. In this context, "leveraging" means building on resources that already exist (data, platforms, prior studies, prototypes, established networks, or other translational infrastructure) so the proposed work can amplify gains in knowledge and/or accelerate technical maturity. The opportunity explicitly welcomes both "knowledge products" (research results that can improve individual or public health, including evidence that can support practice changes) and tangible solutions that speed the introduction of military-relevant products or technologies into clinical or operational settings. Proposals are expected to reflect real-world military constraints, including the varied training levels of likely users (for example, medics versus higher-level clinicians), limited supplies and equipment, and unpredictable environmental conditions typical of combat operations.

In terms of what research is allowed, the RDTRA is not intended for fundamental basic research. The opportunity draws a line between exploratory science aimed at understanding phenomena without a near-term application and applied or preclinical work that is already supported by substantial preliminary or published evidence and is strongly positioned for clinical translation. Within that applied/translational lane, the program can support preclinical studies (including animal work when justified), clinical research, and small-scale early clinical trials such as first-in-human or Phase 1/1b. It specifically does not allow Phase 2 or Phase 3 clinical trials aimed at FDA licensure for drugs or definitive/pivotal testing for FDA device clearance, and it also prohibits studies that would require an Exception from Informed Consent (EFIC), which is often relevant in emergency trauma settings but is not permitted under this announcement.

The announcement uses a broad definition of clinical research that includes patient-oriented studies involving direct interaction with human participants, development and testing of therapeutic interventions, clinical trials, new technology development, as well as epidemiologic, behavioral, outcomes, and health services research. However, purely secondary analyses of existing, de-identified specimens or datasets that qualify for IRB Exemption 4 are not considered "clinical research" under the CDMRP definition used here. For any funded clinical trial, there are transparency requirements, including posting the IRB-approved informed consent form on a public federal website in line with applicable federal rules (referenced as 21 CFR 312).

The work must be relevant to active-duty Service Members, Veterans, military beneficiaries, and/or the broader American public. While the emphasis is clearly on battlefield trauma and military operational medicine, projects that also advance civilian trauma care are allowed, reflecting the reality that military and civilian trauma systems influence each other and may overlap during disasters or large-scale incidents.

On funding structure, applicants choose between two options. The standard RDTRA provides a 2-year period of performance with total costs not to exceed $1.8 million. A second pathway, RDTRA with an Option, supports a base 2-year project plus a potential 1-year option (for a total of up to 3 years). The base and option phases must be distinct but connected, with separate milestones, outcomes, and budgets, and the option is meant to be a true follow-on that leverages what was produced in the base period. Under the option structure, the base phase can be up to $1.8 million and the option year up to $1.0 million. The program also builds in an accountability checkpoint: a virtual milestone review around month 18 of the base period to assess progress against the proposed Statement of Work. Exercising the option is not automatic; it depends on future congressional funding, fit with the next year’s priorities and language, satisfactory performance, and continued program relevance.

Regulatory readiness is treated as a gating issue for anything requiring FDA oversight. If an Investigational New Drug (IND) application or Investigational Device Exemption (IDE) is needed during the base RDTRA period, applicants must show documentation of communication with the FDA indicating the IND/IDE is active and safe to proceed by March 15, 2022, or the application will not be considered for funding. Similar expectations apply when international clinical sites are involved: applicants must provide documentation from the host country regulatory agency indicating the investigational product is active/safe to proceed by the same deadline. If the IND/IDE is only needed in the option year, the documentation must be in place before the end of the base period. In addition, if a clinical trial is included in the RDTRA (or in the base period of the RDTRA with Option), the trial must be initiated no later than month 9 of the initial period of performance, underscoring how strongly this mechanism prioritizes speed and execution.

From a program scale standpoint, the DoD anticipated allocating about $7.2 million total to fund roughly four awards. Awards were expected to be made by September 30, 2022, and the funds were anticipated to be initially obligated using FY21 appropriations with an availability window extending to September 30, 2027. The government also noted it would evaluate extramural applications alongside intramural submissions and could fund any mix of internal and external proposals, depending on merit, program fit, and available funds.

Administrative and compliance requirements are substantial, as is typical for DoD medical research. Human subjects research (including research involving human anatomical substances or cadavers) requires not only local IRB or ethics review, but also review and approval by the USAMRDC Office of Research Protections, Human Research Protection Office (HRPO), before research starts. Local IRB approval is not required at submission, but teams need to plan for HRPO review timelines (often 2 to 3 months). Multi-site cooperative research must include a plan for single-IRB arrangements, naming the lead institution responsible for the master protocol and consent documents as the central regulatory point of contact. Animal research similarly requires both local IACUC review and USAMRDC ACURO review, and applicants are expected to plan for a 3 to 4 month approval window. The opportunity also stresses rigorous experimental design and reproducibility practices (randomization, blinding, sample-size justification, and transparent reporting), and animal studies require a dedicated Animal Research Plan attachment aligned with recognized standards such as ARRIVE.

Finally, the program includes data-sharing expectations for specific topic areas: any prospectively collected human traumatic brain injury (TBI) data generated under this mechanism must be shared through the Federal Interagency Traumatic Brain Injury Research (FITBIR) Informatics System. This requirement is meant to speed progress by enabling broader comparison, reuse, and integration of TBI datasets across the research community.

Overall, the RDTRA is built for teams that already have a credible translational foundation and can move quickly toward real-world deployment or clinical use, with a clear line of sight to near-term impact in combat casualty care and operational medicine, without drifting into basic science or late-stage pivotal trials.

• 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 "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 16, 2021.
• Applicants must submit their applications by Dec 01, 2021. (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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