Opportunity Information: Apply for HT942524VRPTRA
The FY24 Department of Defense Vision Research Program (VRP) Translational Research Award (TRA) is a grant opportunity run through the U.S. Army Medical Research Acquisition Activity (USAMRAA) that focuses on pushing eye- and vision-related discoveries toward real-world clinical use, specifically for eye injury or visual dysfunction linked to military exposures. The central aim is translational work that bridges the gap between promising early findings and clinical-ready solutions that can be definitively tested in later-stage clinical trials. In practical terms, the program is looking for projects that can credibly show how a discovery will become a drug, a medical device, or a clinical practice guideline that is mature enough to justify subsequent full clinical trial testing.
A strong application is expected to lay out a clear, realistic pathway from the current state of the science to a clinically actionable product or practice. That includes concrete development steps, defined milestones, and an explanation of what evidence will be generated during the award period to de-risk the approach for future clinical trials. For teams pursuing drug or device development, the DoD emphasizes the importance of regulatory readiness. Applications should include at least one collaborator with demonstrated expertise in the regulatory approval process, reflecting the program expectation that regulatory strategy is not an afterthought but a core part of translational execution.
If a project involves a product that would require regulatory clearance, the opportunity anticipates that an Investigational New Drug (IND) application or an Investigational Device Exemption (IDE), or an international equivalent, will be submitted to an appropriate Regulatory Agency during the award period or by the end of the period of performance. For this opportunity, "Regulatory Agency" includes the U.S. Food and Drug Administration (FDA) and relevant international counterparts. This expectation signals that the award is meant to move beyond exploratory studies and toward the kind of evidence package and documentation that supports regulated clinical testing.
The funding mechanism also offers a Partnering PI option designed to support genuinely collaborative leadership across institutions or disciplines. Under this structure, the project can name two Principal Investigators: an Initiating PI, who handles most administrative responsibilities for submitting the application, and a Partnering PI, who shares substantive responsibility for developing and carrying out the research. If selected for funding, each PI is listed on a separate award made to their organization (if different), and each award carries its own reporting, regulatory, and administrative requirements. This structure is intended to enable balanced partnerships while keeping accountability clear for each participating organization.
In terms of research scope, the program permits studies involving animals, human subjects, and human anatomical substances. It also allows inclusion of a pilot clinical trial (PCT) component, but it does not support a full-scale clinical trial under this award. The purpose of a PCT in this context is limited clinical testing to inform feasibility, rationale, and the design of future trials, rather than to deliver definitive conclusions about safety or efficacy. Importantly, if an application includes a PCT component, it must also include other non-PCT translational research components, such as preclinical studies or other clinical research activities that are not categorized as a pilot clinical trial. Proposals with a PCT element face additional submission requirements and review criteria, reflecting the higher oversight and planning needs when prospective interventions are tested in humans.
The notice draws a clear line between what counts as a clinical trial versus other types of clinical research. It relies on the federal definition in 45 CFR 46.102: a clinical trial is a study where one or more human subjects are prospectively assigned to one or more interventions (including placebo or control) to evaluate the intervention's effects on biomedical or behavioral health-related outcomes. By contrast, retrospective analyses of data from previously conducted clinical trials are not considered clinical trials for the purposes of this opportunity. The program also distinguishes clinical trials from broader clinical research, which is generally observational and may involve human data, specimens, or interaction with human subjects without prospectively assigning interventions to test safety, effectiveness, or efficacy. Examples of clinical research in this framing include studies on mechanisms of human disease, biomarker or imaging diagnostics, health disparity research, technology development that is not an intervention trial, epidemiologic and behavioral studies that do not test interventions, and outcomes or health services research that does not meet the clinical trial definition. It further notes that certain in vitro studies using human data or specimens that cannot be linked to a living individual, and that meet Common Rule exemption criteria, are excluded from the definition of clinical research.
From the source details provided, this is a discretionary grant opportunity (Funding Opportunity Number HT942524VRPTRA) in the Science and Technology and other Research and Development category, under CFDA 12.420. Eligibility is listed as unrestricted. The original closing date was November 8, 2024. The listing indicates an expected number of awards of one, and an award ceiling is not stated in the provided source fields.Apply for HT942524VRPTRA
- 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, 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 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.
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FY24 DoD Vision Research Program (VRP) Translational Research Award (TRA) FAQs
What is the FY24 DoD VRP Translational Research Award (TRA)?
The FY24 Department of Defense Vision Research Program (VRP) Translational Research Award (TRA) is a discretionary grant opportunity managed through the U.S. Army Medical Research Acquisition Activity (USAMRAA). It supports translational eye and vision research aimed at moving promising discoveries toward real-world clinical use.
What is the main goal of this award?
The central goal is to bridge the gap between early scientific findings and clinical-ready solutions that can be definitively tested in later-stage clinical trials. The program is looking for credible translational work that moves a discovery toward a drug, medical device, or clinical practice guideline mature enough to justify future full clinical trial testing.
What types of vision problems are most relevant to this opportunity?
The focus is on eye injury or visual dysfunction linked to military exposures, with the intent of advancing solutions that are relevant to military-related vision needs.
What kinds of end products is the DoD expecting from funded projects?
Projects should be geared toward producing a clinically actionable product or practice, such as:
- A drug or therapeutic approach
- A medical device
- A clinical practice guideline
The emphasis is on translational maturity and readiness for later-stage clinical testing, not purely exploratory science.
What makes an application competitive according to the opportunity description?
A strong application is expected to present a clear and realistic pathway from the current state of the science to a clinically actionable product or practice. This includes concrete development steps, defined milestones, and a description of what evidence will be generated during the award period to reduce risk and support future clinical trials.
Does the opportunity require a regulatory strategy?
Yes. For drug or device development efforts, the DoD emphasizes regulatory readiness as a core component of translational execution rather than an afterthought.
Is a regulatory expert required on the team?
The opportunity states that applications should include at least one collaborator with demonstrated expertise in the regulatory approval process, reflecting expectations around regulatory planning and execution.
What regulatory submissions are anticipated under this award?
If the project involves a product requiring regulatory clearance, the opportunity anticipates submission of an Investigational New Drug (IND) application or an Investigational Device Exemption (IDE), or an international equivalent, to an appropriate Regulatory Agency during the award period or by the end of the period of performance.
Which agencies count as a "Regulatory Agency" for this award?
For this opportunity, "Regulatory Agency" includes the U.S. Food and Drug Administration (FDA) and relevant international counterparts.
Does this award support studies with animals?
Yes. The scope permits studies involving animals.
Does this award support research involving human subjects?
Yes. The program permits studies involving human subjects.
Does this award allow research using human anatomical substances?
Yes. The program permits studies involving human anatomical substances.
Are clinical trials allowed under this award?
A pilot clinical trial (PCT) component is allowed, but a full-scale clinical trial is not supported under this award. The PCT is intended to inform feasibility, rationale, and the design of future trials rather than provide definitive conclusions about safety or efficacy.
If I include a pilot clinical trial (PCT), do I need other research components too?
Yes. If an application includes a PCT component, it must also include other non-PCT translational research components, such as preclinical studies or other clinical research activities that are not categorized as a pilot clinical trial.
Are there special requirements if my proposal includes a pilot clinical trial?
Yes. Proposals that include a PCT component face additional submission requirements and review criteria, reflecting the increased oversight and planning needs when prospective interventions are tested in humans.
How does the opportunity define a "clinical trial"?
The notice relies on the federal definition at 45 CFR 46.102. A clinical trial is a study where one or more human subjects are prospectively assigned to one or more interventions (including placebo or control) to evaluate the effects of the intervention on biomedical or behavioral health-related outcomes.
Are retrospective analyses of prior clinical trials considered clinical trials for this opportunity?
No. Retrospective analyses of data from previously conducted clinical trials are not considered clinical trials for the purposes of this opportunity.
What is the difference between "clinical research" and a "clinical trial" here?
The program distinguishes clinical trials from broader clinical research. In this framing, clinical research is generally observational and may involve human data, specimens, or interaction with human subjects without prospectively assigning interventions to test safety, effectiveness, or efficacy.
What kinds of work are given as examples of clinical research (not a clinical trial)?
The notice lists examples of clinical research such as studies on mechanisms of human disease, biomarker or imaging diagnostics, health disparity research, technology development that is not an intervention trial, epidemiologic and behavioral studies that do not test interventions, and outcomes or health services research that does not meet the clinical trial definition.
Are some in vitro studies excluded from being considered clinical research?
Yes. The notice notes that certain in vitro studies using human data or specimens that cannot be linked to a living individual, and that meet Common Rule exemption criteria, are excluded from the definition of clinical research.
What is the Partnering PI option?
The funding mechanism includes a Partnering PI option intended to support genuinely collaborative leadership across institutions or disciplines by allowing two Principal Investigators to lead the project.
What is the difference between the Initiating PI and the Partnering PI?
Under the Partnering PI structure:
- The Initiating PI handles most administrative responsibilities for submitting the application.
- The Partnering PI shares substantive responsibility for developing and carrying out the research.
How are awards handled if there are two PIs at different organizations?
If selected for funding, each PI is listed on a separate award made to their organization (if different). Each award includes its own reporting, regulatory, and administrative requirements to keep accountability clear for each participating organization.
Who runs or administers this grant opportunity?
The opportunity is run through the U.S. Army Medical Research Acquisition Activity (USAMRAA) under the Department of Defense Vision Research Program.
What is the Funding Opportunity Number for this program?
The Funding Opportunity Number is HT942524VRPTRA.
What is the CFDA number listed for this opportunity?
The listing includes CFDA 12.420.
What type of grant opportunity is this?
It is listed as a discretionary grant opportunity in the Science and Technology and other Research and Development category.
Who is eligible to apply?
Eligibility is listed as unrestricted.
What was the original closing date for applications?
The original closing date was November 8, 2024.
How many awards are expected?
The listing indicates an expected number of awards of one.
Is there an award ceiling listed in the provided details?
No. The award ceiling is not stated in the provided source fields.
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