Opportunity Information: Apply for W81XWH 19 S CRRP
The DoD Combat Readiness Program (CRRP) Rapid Development and Translational Research Award (RDTRA) is a funding opportunity from the U.S. Army Medical Research Acquisition Activity (USAMRAA) under the Congressionally Directed Medical Research Programs (CDMRP). Its main purpose is to push high-impact, military-relevant medical ideas forward fast, especially ideas that can improve lifesaving care in future combat settings where conditions may be austere, resources limited, evacuation delayed, and mass casualties possible. The emphasis is on getting promising concepts closer to real-world use at the point of greatest need, with a practical focus on prolonged field care and en route care rather than hospital-based specialty care.
The RDTRA is built around translation, meaning the work should help move a concept toward clinical application, operational use, or adoption into practice. That can include healthcare products and technologies (for example, devices, diagnostics, monitoring tools, or therapeutics), as well as practice guidelines and other knowledge products that could directly improve outcomes. A central expectation is that applicants will "leverage" existing translational resources, meaning they should build on prior investments, existing platforms, established datasets, prior prototypes, validated methods, or other concrete groundwork in order to accelerate technical maturity and amplify gains in knowledge. This mechanism is not meant for open-ended discovery science; it explicitly does not support fundamental basic research that lacks a clear line of sight to a specific application or product.
Projects should be designed with realistic battlefield constraints in mind. That includes accounting for wide differences in the training and expertise of potential end users (medics, corpsmen, nurses, physicians, and other providers), and the unpredictable conditions in which a solution might be used (temperature extremes, limited power, low bandwidth, limited supplies, transport vibration, contamination risk, and minimal staffing). While the program is clearly military-focused, proposals that also advance civilian trauma care are allowed, recognizing that military and civilian trauma systems often exchange best practices and innovations.
From a scientific scope standpoint, the award supports translational studies that are already well grounded in strong preliminary or published evidence. Preclinical research is allowed, including animal studies, as long as the data package convincingly supports the likelihood of clinical translation. Research with human subjects and human anatomical substances is permitted, but clinical trials are not allowed. In this announcement, a clinical trial is defined in the standard way: a prospective assignment of human subjects to an intervention (including placebo or control) to evaluate effects on biomedical or behavioral outcomes. So, applicants can do certain types of human research (such as observational studies, feasibility work that does not prospectively assign interventions, or studies involving specimens), but they cannot run an interventional clinical trial under this mechanism.
The opportunity is open to a broad range of applicants (unrestricted eligibility, subject to the detailed rules in the full notice). The government indicates awards may be issued as either grants or cooperative agreements. Which instrument is used depends on how much substantial involvement the DoD expects to have during performance. If the agency anticipates active collaboration, participation, or other hands-on involvement, it may use a cooperative agreement; otherwise, it may use a traditional grant. The final award type and start date are set during negotiations.
Funding levels are substantial but capped per project. The anticipated maximum direct costs for the entire period of performance are up to $1.5 million per award. Programmatically, CDMRP expected to allocate about $13 million total to make roughly five to six awards. As with most federal competitions, actual funding depends on federal appropriations, proposal pressure, and how applications score during both scientific peer review and programmatic review. The notice also highlights fiscal constraints on the use of funds tied to the fiscal year of appropriation, with FY19 funds expected to expire for use on September 30, 2025, and awards anticipated to be made by September 30, 2020.
Several compliance and regulatory expectations are emphasized because the goal is real translation, not just publication. If a project involves an FDA-regulated drug, biologic, or device used for an investigational purpose, the awardee must be ready to operate within FDA pathways. Specifically, if an Investigational New Drug (IND) or Investigational Device Exemption (IDE) is required, evidence must be provided that the IND or IDE has been submitted or will be submitted within 60 days of award. The government reserves the right to withdraw funding if submission does not occur within that 60-day window, or if documented application status is not obtained within 12 months.
If the work involves human subjects, human anatomical substances, or human cadavers, it must go through Department of Defense human research protections review. In addition to any local IRB or ethics review, the USAMRDC Office of Research Protections, Human Research Protection Office (HRPO) must review and approve the work before it begins. Local IRB approval is not required at submission, but applicants are warned to plan for HRPO timelines, typically at least 2 to 3 months, and potentially longer for international studies. If human recruitment is involved, the application must lay out quarterly enrollment targets, and performance milestones for enrollment will be established and monitored, with continued support tied to meeting those milestones.
If the work involves animals, there is a parallel DoD oversight layer. Beyond local IACUC review, the USAMRDC Animal Care and Use Review Office (ACURO) must approve animal use before any animal work starts. The notice flags that ACURO review can take 3 to 4 months and that selected applicants should expect to submit detailed animal-use documentation during award setup. The program also stresses rigor and reproducibility for preclinical work, encouraging established best practices like randomization, blinding, sample-size justification, and transparent data handling, and pointing investigators to widely used frameworks such as Landis standards and the ARRIVE reporting guidelines. Animal studies require an Animal Research Plan attachment describing how rigor standards will be implemented.
The DoD also pays close attention to whether applicants truly have access to the populations and resources they claim they will use. If a project needs access to active duty populations, DoD databases, or other protected DoD resources, the application should document access and include letters of support signed by an appropriate approving authority. Similar documentation is expected for Department of Veterans Affairs (VA) access, including letters from VA facility leadership or designees, and clarity on whether a VA-affiliated nonprofit corporation will administer funds. If access is uncertain or cannot be confirmed, the government can delay, withdraw, or revoke funding until the research team demonstrates real access.
Finally, for traumatic brain injury (TBI) research that generates prospectively collected human subject data, the program requires data sharing through the Federal Interagency Traumatic Brain Injury Research (FITBIR) Informatics System. That comes with concrete planning requirements, including using informed consent language that covers FITBIR sharing and implementing FITBIRs Global Unique Identifier (GUID) process. The GUID requires collecting certain personal identifiers to generate the code, while keeping that personally identifiable information from being transmitted to FITBIR. Applicants are expected to anticipate staffing and cost needs for data submission even though the platform itself is free.
In practical terms, this opportunity is best suited for teams that already have a validated prototype, a strong preclinical data package, a mature translational plan, and a clear path to operational relevance in austere combat care, but who still need targeted funding to cross key readiness thresholds. The program is structured to reward projects that can show near-term progress toward deployable capabilities, field-usable medical guidance, or other implementable solutions that improve survival and outcomes for Service members and, by extension, trauma patients more broadly.Apply for W81XWH 19 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 Sep 10, 2019.
- Applicants must submit their applications by Nov 13, 2019. (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 6 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 Program (CRRP) Rapid Development and Translational Research Award (RDTRA)
What is the RDTRA funding opportunity?
The Rapid Development and Translational Research Award (RDTRA) is a funding opportunity under the Department of Defense (DoD) Combat Readiness Program (CRRP), managed by the U.S. Army Medical Research Acquisition Activity (USAMRAA) within the Congressionally Directed Medical Research Programs (CDMRP). It supports fast-moving, high-impact, military-relevant medical efforts aimed at improving lifesaving care in future combat environments.
What is the main goal of RDTRA?
The primary goal is to accelerate promising medical ideas toward real-world use in combat care settings, especially where conditions are austere, resources are limited, evacuation may be delayed, and mass casualties may occur. The emphasis is on practical solutions that can be used where they are needed most.
What types of care settings are emphasized?
The opportunity is oriented toward prolonged field care and en route care rather than hospital-based specialty care. Applicants are expected to design with battlefield realities in mind.
What does the program mean by "translation"?
Translation means moving a concept closer to clinical application, operational use, or adoption into practice. The work should be structured to advance technical maturity and readiness toward deployment or implementation, not simply generate academic findings.
What types of deliverables are considered responsive?
RDTRA can support translation of healthcare products and technologies (such as devices, diagnostics, monitoring tools, and therapeutics) as well as practice guidelines and other knowledge products that could directly improve outcomes in combat-relevant trauma care.
Is basic discovery research supported?
No. The mechanism is not intended for open-ended discovery science and does not support fundamental basic research that lacks a clear line of sight to a specific application or product.
What does it mean to "leverage" existing translational resources?
Applicants are expected to build on prior investments and concrete groundwork to accelerate progress. Examples include existing platforms, established datasets, prior prototypes, validated methods, and other matured resources that shorten timelines and increase the likelihood of near-term translation.
What battlefield constraints should applicants consider in their project design?
Projects should account for real operational constraints such as variable end-user training (medics, corpsmen, nurses, physicians, and other providers), temperature extremes, limited power, low bandwidth, limited supplies, transport vibration, contamination risk, and minimal staffing.
Can projects have civilian trauma care benefits?
Yes. While the program is military-focused, proposals that also advance civilian trauma care are allowed, reflecting the exchange of best practices and innovations between military and civilian trauma systems.
What level of evidence is expected to support a proposal?
Supported studies should be grounded in strong preliminary or published evidence. The intent is to fund translational work that is already convincingly positioned to move toward operational or clinical use.
Is preclinical research allowed, including animal studies?
Yes. Preclinical research is allowed, including animal studies, as long as the data package convincingly supports the likelihood of clinical translation.
Is human subjects research allowed?
Yes. Research involving human subjects and human anatomical substances is permitted under this opportunity, subject to DoD human research protections requirements.
Are clinical trials allowed under RDTRA?
No. Clinical trials are not allowed. In this announcement, a clinical trial is defined as a prospective assignment of human subjects to an intervention (including placebo or control) to evaluate effects on biomedical or behavioral outcomes.
What kinds of human studies may be possible if clinical trials are not allowed?
The announcement indicates that certain types of human research may be permissible, such as observational studies, feasibility work that does not prospectively assign interventions, and studies involving specimens, as long as the work does not meet the clinical trial definition used in the notice.
Who is eligible to apply?
Eligibility is described as unrestricted, subject to the detailed rules in the full notice. Applicants should still confirm all requirements and constraints in the complete funding announcement.
What type of award instrument will be used?
Awards may be issued as either grants or cooperative agreements. The choice depends on the level of substantial involvement the DoD expects to have during performance. Cooperative agreements are used when active collaboration or hands-on involvement is anticipated; otherwise, a traditional grant may be used.
How much funding is available per award?
The anticipated maximum direct costs for the entire period of performance are up to $1.5 million per award.
How many awards does the program expect to make?
CDMRP expected to allocate about $13 million total to make roughly five to six awards, depending on appropriations, application volume, and review outcomes.
Is funding guaranteed?
No. As with most federal competitions, actual funding depends on federal appropriations, proposal pressure, and how applications score during scientific peer review and programmatic review.
Are there timing constraints related to the appropriated funds?
Yes. The notice highlights fiscal constraints tied to the fiscal year of appropriation, including that FY19 funds were expected to expire for use on September 30, 2025, and awards were anticipated to be made by September 30, 2020.
What FDA-related requirements apply to FDA-regulated products?
If a project involves an FDA-regulated drug, biologic, or device for an investigational purpose, the awardee must be prepared to operate within FDA pathways. If an IND or IDE is required, evidence must be provided that it has been submitted or will be submitted within 60 days of award.
What happens if an IND or IDE is not submitted on time?
The government reserves the right to withdraw funding if the IND/IDE submission does not occur within the 60-day window, or if documented application status is not obtained within 12 months.
What DoD approvals are required for human subjects research?
Projects involving human subjects, human anatomical substances, or human cadavers must undergo DoD human research protections review. In addition to any local IRB or ethics review, the USAMRDC Office of Research Protections, Human Research Protection Office (HRPO) must review and approve the work before it begins.
Is local IRB approval required at the time of application submission?
No. The notice indicates local IRB approval is not required at submission, but applicants are advised to plan for HRPO review timelines before research can start.
How long can HRPO review take?
The notice advises planning for HRPO timelines typically of at least 2 to 3 months, with potentially longer timelines for international studies.
Are there special requirements if the project involves recruiting human participants?
Yes. If human recruitment is involved, the application must include quarterly enrollment targets. Enrollment performance milestones will be established and monitored, and continued support can be tied to meeting those milestones.
What DoD approvals are required for animal research?
Animal studies require approval not only from the local IACUC, but also from the USAMRDC Animal Care and Use Review Office (ACURO) before any animal work begins.
How long can ACURO review take?
The notice flags that ACURO review can take 3 to 4 months. Selected applicants should expect to submit detailed animal-use documentation during award setup.
What rigor and reproducibility expectations apply to preclinical studies?
The program emphasizes rigor and reproducibility and encourages best practices such as randomization, blinding, sample-size justification, and transparent data handling. It points to commonly used frameworks such as Landis standards and the ARRIVE reporting guidelines.
Is an Animal Research Plan required?
Yes. Animal studies require an Animal Research Plan attachment describing how rigor standards will be implemented.
How important is documented access to DoD populations or resources?
It is a major focus. If a project needs access to active duty populations, DoD databases, or other protected DoD resources, the application should document access and include letters of support signed by an appropriate approving authority.
What documentation is expected for Department of Veterans Affairs (VA) access?
Similar documentation is expected for VA access, including letters from VA facility leadership or designees and clarity on whether a VA-affiliated nonprofit corporation will administer funds.
What happens if access to required populations or resources cannot be confirmed?
If access is uncertain or cannot be confirmed, the government may delay, withdraw, or revoke funding until the research team demonstrates real access.
Are there data sharing requirements for traumatic brain injury (TBI) research?
Yes. For TBI research that generates prospectively collected human subject data, data sharing through the Federal Interagency Traumatic Brain Injury Research (FITBIR) Informatics System is required.
What planning is needed for FITBIR data sharing?
The notice describes requirements such as using informed consent language that covers FITBIR sharing and implementing FITBIR's Global Unique Identifier (GUID) process.
What is the FITBIR GUID process?
The GUID process requires collecting certain personal identifiers to generate a code, while ensuring that personally identifiable information is not transmitted to FITBIR.
Should applicants budget for FITBIR data submission?
Yes. Applicants are expected to anticipate staffing and cost needs for data submission even though the FITBIR platform itself is free.
What kinds of teams or projects are the best fit for RDTRA?
The opportunity is best suited for teams that already have a validated prototype, a strong preclinical data package, a mature translational plan, and a clear path to operational relevance in austere combat care, but need targeted funding to cross key readiness thresholds.
What kinds of outcomes is the program trying to accelerate?
The structure is designed to reward near-term progress toward deployable capabilities, field-usable medical guidance, or other implementable solutions that improve survival and outcomes for Service members and, more broadly, trauma patients.
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