DOD Peer Reviewed Orthopaedic, Applied Research Award | HT9425 23 PRORP ARA

Opportunity Information: Apply for HT9425 23 PRORP ARA

The DOD Peer Reviewed Orthopaedic Research Program (PRORP) Applied Research Award (ARA) is a Department of Defense funding opportunity designed to move practical, near-term orthopaedic and musculoskeletal injury solutions closer to real-world use, with a clear emphasis on improving military readiness and helping injured Service Members return to duty, work, and everyday function faster. The program is motivated by the scale and seriousness of extremity and musculoskeletal injuries in military settings, including combat-related wounds (which account for a large share of injuries captured in the DOD Trauma Registry) as well as the very common non-combat injuries that happen during training, sports, and routine service life. A core theme is that earlier stabilization, treatment, and rehabilitation can reduce complications, minimize long-term disability, and even reduce limb loss, especially when care and effective tools can be deployed as close to the point of injury as possible. While the military impact is front and center, the DOD also expects the work to translate broadly and benefit civilian patients with similar injuries.

This award mechanism is specifically for applied, preclinical research rather than discovery-driven basic science or human clinical studies. In the PRORP definition, applied research means taking promising concepts and turning them into workable, testable solutions, then generating evidence about feasibility and performance so those solutions can advance toward clinical translation. Examples include developing and testing knowledge products, devices or systems, pharmacologic or biologic candidates, rehabilitation or behavioral interventions, diagnostic or therapeutic techniques, clinical guidance, and other emerging approaches or technologies. The scope can range from smaller studies to larger preclinical projects, but the expectation is that by the end of the project the deliverables are meaningfully closer to practical use, not just exploratory findings. A strong transition plan is treated as an important part of competitiveness, meaning applicants should explain how results will be positioned for the next step, such as advanced development, regulatory planning, or eventual clinical evaluation under a different award mechanism.

Eligibility is described as unrestricted (open to any type of entity, subject to any additional eligibility notes in the full announcement). However, proposals must align with and explicitly address one of the FY23 PRORP ARA Focus Areas referenced in the opportunity (the focus area list is in the full solicitation text). The program also requires that applicants bring preliminary and/or published data that is directly relevant to the proposed work, and that they present a clear scientific rationale with a well-formed, testable hypothesis grounded in a critical review of the existing literature. In other words, reviewers are looking for a logical, evidence-backed argument that the approach is worth maturing and that the proposed studies are designed to answer concrete, decision-driving questions.

The opportunity clearly draws boundaries around what it will and will not fund. It cannot be used for fundamental basic research, defined here as work aimed at understanding underlying phenomena without a specific application in mind. It also cannot be used for clinical research, which the DOD defines broadly to include patient-oriented research involving direct interaction with human subjects, studies of mechanisms of human disease in humans, therapeutic interventions in people, clinical trials, as well as epidemiologic, behavioral, outcomes, and health services research. One narrow exception is noted: studies that qualify for Institutional Review Board (IRB) Exemption 4 (using existing, de-identified specimens or data that are publicly available) are not considered clinical research under CDMRP definitions. Applicants who want to do human studies are directed instead to the FY23 PRORP Clinical Translational Research Award (CTRA) or the PRORP Clinical Trial Award (CTA), which are separate funding mechanisms.

Typical project types that fit this ARA include refining and validating potential solutions or research tools, evaluating and down-selecting candidate products (such as drugs, biologic constructs, or devices/systems) using in vitro and/or in vivo testing, and conducting preparatory activities that support a later clinical trial or regulatory submission. The through-line is that the work should de-risk a technology or approach and provide the kind of data package that allows a credible next step toward translation.

From a funding and administration perspective, the DOD expects to make assistance agreements, which can be issued as either grants or cooperative agreements. The deciding factor is how much substantial involvement the DOD anticipates during performance. If substantial involvement is expected (for example, collaboration or participation by the agency in the research), the award will be a cooperative agreement; if not, it will be a grant. The planned budget guideline is that total costs over the entire period of performance should not exceed 750,000 per award. The program projected roughly 3.75 million total to support about five awards, with final funding dependent on federal fund availability and the number and quality of applications as determined by scientific and programmatic review. Awards were expected to be made by no later than September 30, 2024. The funding is tied to FY23 appropriations and is expected to remain available for obligation and use within the allowable window, with FY23 funds noted as expiring for use on September 30, 2029.

Key administrative details from the listing include the funding opportunity number HT9425-23-PRORP-ARA, agency involvement through the Department of Defense (Department of the Army, USAMRAA), CFDA 12.420, and the original application closing date of September 13, 2023. Overall, the ARA is built for teams that already have a credible starting evidence base and want to generate the preclinical feasibility and maturation data needed to move orthopaedic injury solutions toward deployment and eventual clinical impact, with a strong emphasis on readiness, function restoration, and faster return to duty or work.

• 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 Peer Reviewed Orthopaedic, Applied 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 Apr 19, 2023.
• Applicants must submit their applications by Sep 13, 2023. (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 5 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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