DoD VRP, Clinical Trial Award | HT942524VRPCTA

Opportunity Information: Apply for HT942524VRPCTA

The FY24 Vision Research Program (VRP) Clinical Trial Award (CTA) is a Department of Defense grant opportunity aimed at quickly launching early-phase clinical trials that could meaningfully improve the treatment or management of service-connected eye injuries and visual dysfunction. The focus is strongly translational and action-oriented: projects are expected to move a promising intervention into human testing on a timeline that supports near-term impact for affected Service Members and Veterans. Trials may evaluate new or emerging products and technologies, including drugs or biologics, medical devices, clinical guidance, or other innovative approaches intended to address vision-related injury and dysfunction connected to military service.

A central requirement of this funding mechanism is that the proposed work must meet the federal definition of a clinical trial under 45 CFR 46.102. In practical terms, the study must prospectively assign one or more human participants to one or more interventions (including placebo or control when appropriate) and then evaluate the effects of that intervention on biomedical or behavioral health-related outcomes. The program is explicit that studies that do not measure safety, effectiveness, and/or efficacy outcomes of an intervention do not qualify as clinical trials for this award. Applicants whose projects do not meet the clinical trial definition are directed to consider other FY24 VRP announcements instead. The opportunity also points applicants to a dedicated Human Subjects Resource Document hosted by CDMRP to help teams navigate expectations and compliance for human research protections.

Because these awards are meant to support real clinical testing, regulatory readiness is a major emphasis. For drug or biologic trials involving products that are not already approved by the relevant regulatory authority in the country where the trial will be conducted, an Investigational New Drug (IND) application (or an equivalent international submission) may be required, consistent with 21 CFR 312. If the applicant believes an IND is not required, the burden is on the applicant to provide evidence from the Institutional Review Board (IRB) of record or from the relevant regulatory agency supporting that determination. If an IND (or equivalent) is required, it must be submitted to the appropriate regulatory agency by the FY24 VRP CTA application submission deadline, and the applicant must also provide documentation showing the regulatory agency has the IND in an active status or has indicated it is safe to proceed by March 1, 2025 for the application to remain eligible for funding consideration. The IND is expected to align specifically with the product and the indication being tested in the proposed trial.

A parallel set of requirements applies to device studies. If the investigational product is a device that requires an Investigational Device Exemption (IDE) under 21 CFR 812 (or an international equivalent), applicants must either provide evidence that an IDE is not required or, when required, submit the IDE to the relevant regulatory agency by the application deadline. As with INDs, the program requires documentation from the regulatory agency indicating the IDE is active or the study is safe to proceed by March 1, 2025 for the proposal to remain in consideration. The IDE (or equivalent) should also be specific to the device and the indication being evaluated.

Operationally, the program expects speed and feasibility: the proposed clinical trial should begin no later than six months after the award date, reinforcing that this mechanism is intended for projects that are ready to execute rather than early concept development. Administrative details from the posting indicate it is a discretionary grant administered by the Department of the Army, U.S. Army Medical Research Acquisition Activity (USAMRAA), under CFDA 12.420 (science and technology and other research and development). Eligibility is listed as unrestricted, the opportunity number is HT942524VRPCTA, and the posted closing date is November 8, 2024. The listing notes an expectation of one award, while the award ceiling is not specified in the provided summary.

• The Dept. of the Army -- USAMRAA in the science and technology and other research and development sector is offering a public funding opportunity titled "DoD VRP, Clinical Trial 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 2024-05-16.
• Applicants must submit their applications by 2024-11-08. (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 1 candidate(s).
• Eligible applicants include: Unrestricted.

Apply for HT942524VRPCTA

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