Closed · HT942524VRPCTA · CFDA 12.420 · Discretionary
DoD VRP, Clinical Trial Award
Federal grant opportunity posted by Dept. of the Army -- USAMRAA, cataloged on Grants.gov.
- Varies
- Award range
- Closed
- Status
- November 12, 2024
- Close date
- 1
- Expected awards
The verdict
DoD VRP, Clinical Trial Award is a closed discretionary listing from Dept. of the Army -- USAMRAA that offered Varies by applicant across 1 expected award. Future funding cycles may be published under the same CFDA number.
- Varies
- award range
- Closed
- application status
- 1
- expected award
- 12.420
- CFDA program
Opportunity snapshot. This Grants.gov announcement - DoD VRP, Clinical Trial Award - is cataloged under number HT942524VRPCTA and tied to CFDA assistance listing 12.420, posted by Dept. of the Army -- USAMRAA. Grants.gov currently shows the opportunity as closed, first posted on May 16, 2024 and last updated on November 8, 2024. The funding category is Discretionary, delivered as a grant.
Award economics. The award range on file is Varies by applicant. The agency has projected $2.6 million in total estimated funding for this announcement. It expects to issue 1 award. If the agency funds the expected 1 award from the $2.6 million estimated pool, the average award works out to roughly $2.6 million. Cost sharing is not required, so applicants do not need to commit matching funds to be competitive on this opportunity. Federal award ranges are often upper bounds; actual allocations reflect program appropriations, the strength of the applicant pool, and the evaluation committee's scoring.
Deadline and action path. This opportunity closed on November 12, 2024. Future funding cycles may be published under the same CFDA number, so monitoring the parent program page is the most reliable way to catch re-announcements. Every Grants.gov submission requires an active SAM.gov registration and a Unique Entity ID. Review the Eligibility section below carefully, federal eligibility categories (nonprofit, state or local government, tribal, individual, educational institution, small business) have distinct registration and reporting requirements. Pre-application outreach to the listed agency contact is permitted and often welcomed, it helps clarify scope and scoring priorities. Before acting on the deadline or award figures above, verify them directly on the official Grants.gov listing, amendments can change dates and amounts after this page was last refreshed.
Award Range
Varies by applicant
Close Date
November 12, 2024
Posted
May 16, 2024
Est. Total Funding
$2,560,000
Expected Awards
1
Instrument
Grant
Description
The FY24 VRP CTA supports the rapid implementation of early-phase clinical trials with the potential to have a significant impact on the treatment or management of service-connected eye injury and visual dysfunction.Clinical trials may be designed to evaluate promising new products, pharmacologic agents (drugs or biologics), devices, clinical guidance, and/or emerging approaches and technologies.Funding from this award mechanism must support a clinical trial. A clinical trial is defined in the Code of Federal Regulations, Title 45, Part 46.102 (45 CFR 46.102) as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include a placebo or another control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.Studies that do not seek to measure safety, effectiveness, and/or efficacy outcome(s) of an intervention are not considered clinical trials.Applicants seeking funding for research that does not meet this definition should consider one of the other FY24 VRP program announcements being offered.For more information, a Human Subject Resource Document is provided at https://cdmrp.health.mil/pubs/pdf/Human%20Subjects%20Resource%20Document_DEC2022.pdfFor the purposes of this funding opportunity, Regulatory Agency refers to the U.S. Food and Drug Administration (FDA) or any relevant international Regulatory Agency unless otherwise noted.If the proposed clinical trial involves the use of a drug that has not been approved by the relevant Regulatory Agency for the country where the research will be conducted, then submission of an Investigational New Drug (IND) application, or equivalent, that meets all requirements under 21 CFR 312 may be required. It is the responsibility of the applicant to provide evidence from the Institutional Review Board (IRB) of record or the relevant Regulatory Agency if an IND, or equivalent, is not required. If an IND, or equivalent, is required, the regulatory application must be submitted to the relevant Regulatory Agency by the FY24 VRP CTA application submission deadline. In addition, applicants must provide documentation of communication from the Regulatory Agency indicating that the IND, or equivalent, is active/safe to proceed by March 1, 2025, in order for the FY24 VRP CTA application to be considered for funding. Refer to Attachment 10: Regulatory Strategy for further details. The IND, or equivalent, should be specific for the product and indication to be tested in the proposed clinical trial. For more information on IND applications specifically, the FDA has provided guidance at https://www.fda.gov/drugs/types-applications/investigational-new-drug-ind-application.If the investigational product is a device, then submission of an Investigational Device Exemption (IDE) application, or equivalent, that meets all requirements under 21 CFR 812 may be required. It is the responsibility of the applicant to provide evidence if an IDE, or equivalent, is not required. If an IDE, or equivalent, is required, the regulatory application must be submitted to the relevant Regulatory Agency by the FY24 VRP CTA application submission deadline. In addition, applicants must provide documentation of communication from the Regulatory Agency indicating that the IDE, or equivalent, is active/safe to proceed by March 1, 2025, in order for the FY24 VRP CTA application to be considered for funding. Refer to Attachment 10: Regulatory Strategy for further details. The IDE, or equivalent, should be specific for the device and indication to be tested in the proposed clinical trial.The proposed clinical trial is expected to begin no later than 6 months after the award date.
Eligibility
Grants.gov lists this opportunity under eligibility category code 99. These codes correspond to applicant types (state/local government, tribal organization, nonprofit, educational institution, individual, small business, etc.) defined in Grants.gov's own eligibility reference. See the current Grants.gov eligibility categories or check the official listing below for this opportunity's exact eligibility statement.
Official Listing on Grants.gov
View full details, application forms, and submission instructions.
Agency Contact
CDMRP Help Desk Phone: 301-682-5507 Email: help@eBRAP.org
Key Dates
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| Sources | the SAM.gov Assistance Listings and Grants.gov |