Combat Casualty Care - Multi-Domain Lifesaving Trauma Innovations (MuLTI) Award | W81XWH 19 S CCC1

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The Combat Casualty Care - Multi-Domain Lifesaving Trauma Innovations (MuLTI) Award is a U.S. Department of Defense research funding opportunity run through the U.S. Army Medical Research Acquisition Activity (USAMRAA) under the Combat Casualty Care Research Program (CCCRP) and Joint Program Committee-6 (JPC-6). Its basic purpose is to push forward practical, near-term innovations that improve trauma care and survivability in operational settings, with an emphasis on work that can realistically translate into usable medical capabilities rather than open-ended discovery science. The award is competed under a Broad Agency Announcement (BAA) structure, and proposals from outside DoD (extramural) are reviewed in the same pool as proposals from inside DoD organizations (intramural). The government explicitly reserves the right to fund any mix of extramural and intramural efforts based on merit, program fit, and available funds.

In terms of overall scale, the program projected roughly 10.7 million dollars from FY19 appropriations, 9.9 million from FY20, and 9.5 million from FY21 (all Defense Health Program RDT&E funds), with an expectation of funding on the order of about 12 to 30 awards from the FY19 cycle depending on the number and quality of submissions. These totals are estimates, not guarantees, and the announcement stresses that funding depends on congressional appropriations and may be realigned. For individual projects, the total cost cap for the full period of performance depends on whether the work enrolls human subjects prospectively or qualifies as a clinical trial. Projects involving prospective accrual of human subjects and clinical trials may request up to 2.5 million dollars in total costs (direct plus indirect). All other types of research are capped at 1.0 million dollars total costs.

A key boundary for this program is that it does not support fundamental basic research. The DoD draws a clear line here: basic research aimed at general knowledge without a specific application in mind is considered out of scope. Instead, MuLTI is positioned for applied and translational efforts, including preclinical studies, clinical research, and early-stage clinical testing such as Phase 0 and Phase I trials. At the same time, the program is not intended to pay for later-stage, definitive regulatory trials. Phase II and Phase III clinical trials for FDA licensure of drugs and pivotal/definitive testing intended to support FDA device clearance are explicitly not allowed under this BAA. In practice, that means the program is geared toward establishing feasibility, early safety, proof-of-concept, and de-risking steps that move a trauma-care technology or intervention toward operational use, without paying for the expensive confirmatory trials typically required for broad regulatory approval.

The announcement also explains the contracting and assistance mechanisms the government may use. USAMRMC (the broader command executing the extramural program) can fund work using grants, cooperative agreements, or procurement contracts, and the final instrument is chosen by the government based on the nature of the relationship and the applicable legal standards in 31 USC 6301-6308. If the government expects no substantial involvement in how the research is carried out, a grant is typically used. If the government expects substantial involvement (for example, active collaboration, participation, or intervention in the work), a cooperative agreement is more likely, and the award will spell out what that involvement looks like. If the main purpose is to acquire a product or service for direct government use, a contract is used instead. For contract awards specifically, there is also a pathway for prototype-related efforts: USAMRAA may include optional line items for advanced component development or delivery of prototype units, but such additions are limited by National Defense Authorization Act provisions (notably NDAA FY2010 Section 819 as modified by NDAA FY2015 Section 811).

For studies that enroll human participants, the MuLTI Award sets concrete planning and accountability expectations. Applicants have to lay out quarterly enrollment targets across all participating sites in the Statement of Work, and awardees then work with USAMRAA to formalize recruitment milestones. Continued support is tied to satisfactory progress against those milestones, which signals that the program is serious about execution and timelines rather than leaving enrollment as an open-ended risk. If the project involves FDA-regulated products, the announcement is equally direct about regulatory readiness. For unapproved drugs or biologics used investigationally, the awardee must provide evidence that an Investigational New Drug (IND) application has been or will be submitted to FDA within 60 days of award. For investigational devices, an Investigational Device Exemption (IDE) submission or status documentation is similarly required within 60 days. The government can withdraw funding if the IND/IDE is not submitted within that 60-day window, or if documented application status is not obtained within 12 months, which effectively forces teams to plan their regulatory strategy early.

If a proposed clinical trial spans multiple institutions, the program expects a clear governance and coordination plan. The application should describe the multi-site structure and identify a lead organization responsible for developing the master protocol and master consent form, serving as the single point of contact for regulatory submissions. The DoD strongly recommends using a single IRB or ethics committee pathway when feasible to streamline oversight. Before other sites receive the master documents for their own reviews, the USAMRMC Office of Research Protections (ORP), through the Human Research Protection Office (HRPO), must review the master protocol and consent. The application should also address how collaborating institutions will communicate and transfer data, how specimens or imaging outputs will be handled, and it must include an intellectual and material property plan that all participating institutions agree to, which is a common friction point in multi-site studies and is treated here as a required up-front deliverable.

Oversight requirements are a major feature of the opportunity, especially for human and animal research. Any DoD-funded work involving human subjects, human anatomical substances, or human cadavers must receive HRPO approval before research begins, in addition to local IRB/EC review. Importantly, local IRB approval is not required at the time of application submission, but HRPO review is still mandatory before initiation, and teams are told to budget time for it: typically 2 to 4 months, with potentially longer timelines for international clinical studies. The announcement also warns investigators to keep protocols aligned to the DoD-funded scope where possible, because if a protocol covers both DoD- and non-DoD-funded activities, HRPO may review the entire protocol and DoD human-subjects requirements could then be applied across the broader, non-DoD work, potentially triggering additional revisions. For studies judged by an IRB to involve more than minimal risk, DoD requires an independent research monitor with expertise appropriate to the identified risks, reinforcing the program's emphasis on participant protection and safety reporting.

Animal research is handled with similar rigor. Any DoD-funded animal work must be reviewed and approved not only by the institution's IACUC, but also by USAMRMC ORP's Animal Care and Use Review Office (ACURO). As with human subjects, IACUC approval is not required at submission, but ACURO approval is required before animal work starts, and investigators are advised to plan for at least 3 to 4 months for the ACURO review process. If selected for funding, the awardee will be required to provide specific documentation, including the institutional animal use protocol, evidence of IACUC approval, and the required DoD animal-use appendix materials.

Finally, the opportunity puts real weight on study quality, reproducibility, and translational credibility. Applicants are expected to follow accepted standards for rigorous experimental design and reporting, including principles like randomization, blinding, appropriate sample-size estimation, and transparent data handling. For animal model work, an Animal Research Plan attachment is required to explain how these rigor standards will be met, and applicants are encouraged to align with ARRIVE guidelines. This is meant to reduce wasted effort from underpowered or biased studies and to increase the chances that preclinical findings can actually support a meaningful next step toward a fieldable trauma-care solution.

Administrative details from the posting include the funding opportunity number W81XWH-19-S-CCC1, an unrestricted eligibility statement (open broadly to applicant types, subject to the full announcement text), an original closing date of May 29, 2019, and an expected award count around 20 (noting the broader estimate range of 12 to 30). Overall, MuLTI is best read as a DoD translational trauma innovation mechanism: relatively sizable awards, a preference for actionable development and early clinical evaluation, strict limits against late-stage pivotal trials, and heavy emphasis on regulatory planning, milestone-based execution, and compliance with DoD human and animal protections.

• 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 Casualty Care - Multi-Domain Lifesaving Trauma Innovations (MuLTI) 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 Jan 18, 2019.
• Applicants must submit their applications by May 29, 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 20 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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