DoD Military Burn, Technology/Therapeutic Development Award | W81XWH 22 MBRP TTDA

Opportunity Information: Apply for W81XWH 22 MBRP TTDA

The DoD Military Burn Research Program (MBRP) Technology/Therapeutic Development Award (TTDA) is a product-driven funding opportunity focused on pushing promising, well-supported preclinical burn research toward real-world clinical products. The central goal is translation: taking a technology or therapeutic that already has meaningful early evidence behind it and moving it closer to clinical application, specifically in ways that address one or more critical gaps identified in the FY22 MBRP TTDA Focus Areas. A strong emphasis is placed on relevance to military needs, meaning the proposed product should be clearly tied to challenges faced by burn-injured Service Members, Veterans, and other military beneficiaries, while also potentially benefiting the broader public.

The award supports development of tangible medical products such as drugs, biologics, and other pharmacologic agents, as well as device-based solutions. It can also support "knowledge products" when they are directly applicable to a technology or therapeutic under development. In this context, a knowledge product is not just general information or basic science findings; it is a non-materiel deliverable grounded in evidence that is meant to transition into practice, training, clinical tools, or other implementable solutions across the continuum of care, including prevention of negative outcomes. In other words, even if the end product is guidance, training, or a tool, it must be designed to change practice or support the deployment of medical solutions rather than simply describing a problem.

A defining feature of the TTDA is that applicants must come in with more than a concept. By the pre-application stage, the product must already be at least Technology Readiness Level (TRL) 3 or Knowledge Readiness Level (KRL) 3, meaning there must be a demonstrated proof-of-concept. The solicitation also expects that a prototype or preliminary version of the product already exists and that its potential utility has been shown. Applications must include data supporting the rationale for the work, and those data can be unpublished or drawn from the scientific literature. This makes the mechanism best suited for teams that have already generated substantial preliminary results and are ready to tackle the practical development steps needed to move toward human use, but are not yet at clinical deployment.

The types of activities the program is looking to fund are generally the translational, enabling steps that sit between discovery research and clinical use. Examples include testing new therapeutic or technological modalities in established or validated preclinical systems, validating or testing devices, improving delivery systems, or chemically optimizing lead compounds. It can also include planning and executing pilot or full-scale Good Manufacturing Practice (GMP) production for therapeutics or technologies to support advanced preclinical work. For drugs and similar agents, the award can fund key development tasks like absorption, distribution, metabolism, excretion, and toxicity (ADME/Tox) studies. It may also support regulatory-enabling packages, including work intended to support an Investigational New Drug (IND) application or an Investigational Device Exemption (IDE), which are often major milestones on the path toward human testing.

Because this is a Department of Defense assistance mechanism, awards are made as either grants or cooperative agreements. Which one is used depends on how involved the DoD expects to be during performance. If the agency anticipates no substantial involvement, it will typically be a grant; if substantial involvement is anticipated (for example, collaboration or active participation by the DoD in the project), it will be a cooperative agreement, and the specific nature of that involvement will be spelled out in the award. This matters for planning because a cooperative agreement can imply closer coordination, additional reporting expectations, or more structured engagement with program staff.

Funding levels are relatively high for a translational program, reflecting the cost of product development work. The total cost cap for an individual FY22 MBRP TTDA award is not to exceed $2.21 million across the full period of performance. The program planned to allocate about $4.42 million total to fund roughly two awards, though actual funding depends on federal availability and the quality and programmatic fit of proposals. Awards were expected to be made no later than September 30, 2023, and FY22 funds associated with awards were anticipated to remain available for use until September 30, 2028, which is important for understanding the government fiscal timeline even when project performance spans multiple years.

Impact is treated as a core review consideration, not a secondary feature. Applicants are expected to clearly identify which FY22 MBRP Focus Area gap they are addressing and explain both near-term and long-term benefits to burn-injured individuals. The solicitation highlights outcomes such as improved prevention, detection, diagnosis, treatment, and standards of care, with the ultimate aim of improving survivorship and long-term recovery for burn casualties. The military relevance requirement is also explicit: proposals should explain how the project addresses burn injury needs that matter in military contexts and how the product or knowledge could realistically be implemented to meet a military requirement, not just succeed scientifically in a lab setting.

The opportunity encourages alignment with DoD and Department of Veterans Affairs (VA) research resources. If a project needs access to active-duty or VA patient populations, or intends to use DoD/VA databases or resources, the application must describe how access will be obtained and sustained throughout the project. While collaboration with DoD or VA investigators is not mandatory, it is encouraged, and applicants are pointed toward resources to identify potential partners and align with existing military research priorities.

A key boundary condition is that clinical trials and clinical research studies are not allowed under this specific award mechanism. The TTDA is positioned firmly in the advanced preclinical and product-development space. However, certain work involving human materials is allowed: studies using human anatomical specimens can be permitted when necessary for device validation or for in vitro or ex vivo work. The announcement also provides definitions clarifying what counts as a clinical trial and what the program considers clinical research, and it notes that some studies using existing de-identified specimens or data (for example, those meeting IRB Exemption 4) are not considered CDMRP-defined clinical research. Applicants who want to do human subject clinical research are directed instead to the FY22 MBRP Clinical Translational Research Award mechanism.

The solicitation also signals a strong expectation for rigorous, reproducible experimental design, especially for preclinical and animal work. It references widely used standards emphasizing randomization, blinding, sample-size estimation, and transparent data handling, and it requires an Animal Research Plan attachment for projects using animal models. Applicants are encouraged to use ARRIVE guidelines 2.0 as a planning and reporting framework, reinforcing that the program is not just funding results, but funding results that are credible and more likely to translate.

Finally, the announcement lays out important regulatory and compliance requirements. DoD-funded projects involving human anatomical substances, human subjects, or human cadavers must undergo review by the USAMRDC Office of Research Protections, Human Research Protection Office (HRPO), in addition to any local IRB or ethics review, and teams should plan for the HRPO process to take up to about three months after submission of complete materials. Multi-institution human research also requires a plan for single IRB arrangements. For animal research, approval is required not only from the institution’s IACUC but also from the USAMRDC Animal Care and Use Review Office (ACURO), with a typical review timeline of at least three to four months. These timelines matter because they can affect how quickly the work can actually begin, even after an award is made.

Overall, the FY22 DoD MBRP TTDA is designed for teams that already have a credible proof-of-concept and are ready to do the hard translational work: refining a product, generating advanced preclinical evidence, preparing for manufacturing and regulatory pathways, and laying out a realistic transition plan to move beyond the grant into the next development stage, such as future clinical trials or eventual delivery to military and civilian healthcare systems.

• 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 Military Burn, Technology/Therapeutic Development 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 May 20, 2022.
• Applicants must submit their applications by Oct 11, 2022. (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 2 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.

Apply for W81XWH 22 MBRP TTDA

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