Opportunity Information: Apply for W81XWH 15 NFRP CTA
Apply for W81XWH 15 NFRP CTA
- 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 Neurofibromatosis 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 Military Medical Research and Development.
- This funding opportunity was created on May 6, 2015 and posted on May 6, 2015.
- Applicants must submit their applications by Jul 27, 2015. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $2,880,000.00 to eligible and selected applicants.
- 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.
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Opportunity Summary:
The DoD Neurofibromatosis Clinical Trial Award (NFRP CTA) is a Department of Defense funding opportunity run through the U.S. Army Medical Research Acquisition Activity (USAMRAA) under the Neurofibromatosis Research Program (NFRP). Its purpose is to support clinical trial research that could meaningfully improve the treatment or day-to-day management of neurofibromatosis (NF). The program is specifically aimed at studies that can move the field forward in a practical, patient-facing way, rather than early laboratory or animal work.
This award is strictly for clinical trials, meaning the funded project must prospectively enroll human participants and test an intervention in people while measuring outcomes tied to safety, effectiveness, efficacy, or other exploratory clinical information. The announcement gives a broad view of what counts as an intervention, including drugs or biologics, medical devices, surgical procedures, rehabilitative approaches, behavioral interventions, clinical guidance, and other emerging technologies or methods. A key point is that the measurable outcome must represent a direct effect on the human subject caused by the intervention or interaction being tested.
The mechanism is flexible about the stage and scale of the clinical trial. It can support smaller, early-stage efforts such as pilot studies, first-in-human work, or Phase 0 trials that are intended to demonstrate feasibility or generate information needed to design a larger study. It can also support larger-scale trials designed to determine efficacy in the appropriate patient population. The common thread across these options is that the work must be trial-based and positioned to produce clinically relevant evidence for NF.
Preclinical research is explicitly not allowed under this mechanism. Funds cannot be used for studies that are solely laboratory-based, animal-based, or otherwise outside a true human-subjects clinical trial framework. Investigators whose projects are preclinical are directed to other NFRP award mechanisms offered in the same fiscal year instead of this one.
The opportunity also spells out expectations for evidence supporting the proposed trial. For pilot trials, applicants must include a scientific rationale and/or preliminary data that are relevant to the pilot clinical trial being proposed. For Phase I or Phase II trials, the requirements are more stringent: both a clear scientific rationale and preliminary data relevant to the proposed trial are required. This is meant to ensure that trials are grounded in enough prior knowledge to justify enrolling participants and testing the intervention.
Administratively, this opportunity was listed as Funding Opportunity Number W81XWH-15-NFRP-CTA and categorized as discretionary funding. The funding instrument types include cooperative agreement and grant, and it falls under the Department of Defense medical research and development CFDA listing 12.420 (Military Medical Research and Development). The total estimated funding was $2,880,000 with an expected two awards, and there was no cost sharing or matching requirement. Eligibility was described as unrestricted (open to any type of entity), subject to any additional clarifications in the full text of the announcement.
Key dates for this archived announcement were a posted date of May 6, 2015, an original and final closing date of July 27, 2015, and an archive date of August 26, 2015. Applicants were also pointed to a Human Subject Resource Document available through eBRAP (https://ebrap.org/eBRAP/public/Program.htm) for guidance on human-subjects considerations within the program context. For help accessing the full announcement, the contact listed was the CDMRP Help Desk at 301-682-5507.
DoD Neurofibromatosis Clinical Trial Award (NFRP CTA) - FAQs
What is the DoD Neurofibromatosis Clinical Trial Award (NFRP CTA)?
The NFRP CTA is a Department of Defense funding opportunity under the Neurofibromatosis Research Program (NFRP), administered through the U.S. Army Medical Research Acquisition Activity (USAMRAA). It supports clinical trial research intended to meaningfully improve treatment or day-to-day management of neurofibromatosis (NF).
What is the primary purpose of this award?
The purpose is to fund human clinical trials that move the field forward in a practical, patient-facing way by generating clinically relevant evidence that can improve NF treatment or management.
Is this funding intended for basic science, lab research, or animal studies?
No. Preclinical research is explicitly not allowed. Funds cannot be used for studies that are solely laboratory-based, animal-based, or otherwise outside a true human-subjects clinical trial framework.
What types of studies are eligible under this mechanism?
Only clinical trials are eligible. The project must prospectively enroll human participants and test an intervention in people while measuring outcomes tied to safety, effectiveness, efficacy, or other exploratory clinical information.
How does the announcement define a "clinical trial" for this award?
A funded project must prospectively enroll human participants, test an intervention in humans, and measure outcomes related to safety, effectiveness, efficacy, or other exploratory clinical information. The outcome must reflect a direct effect on the human subject caused by the intervention or interaction being tested.
What counts as an "intervention" under this opportunity?
The announcement describes interventions broadly, including drugs or biologics, medical devices, surgical procedures, rehabilitative approaches, behavioral interventions, clinical guidance, and other emerging technologies or methods.
What kind of outcomes must be measured?
The measurable outcomes must represent a direct effect on the human subject that is caused by the intervention or interaction being tested. Outcomes may relate to safety, effectiveness, efficacy, or other exploratory clinical information.
Does the award support early-stage trials like pilot studies or Phase 0 trials?
Yes. The mechanism is flexible and can support smaller, early-stage efforts such as pilot studies, first-in-human work, or Phase 0 trials intended to demonstrate feasibility or generate information needed to design a larger study.
Does the award support larger clinical trials designed to determine efficacy?
Yes. It can also support larger-scale trials intended to determine efficacy in the appropriate patient population, as long as the work is trial-based and positioned to produce clinically relevant evidence for NF.
Are Phase I and Phase II clinical trials allowed?
Yes. The opportunity describes Phase I and Phase II trials as within scope, with specific expectations for scientific rationale and preliminary data.
What evidence is required to support a pilot clinical trial application?
For pilot trials, applicants must include a scientific rationale and/or preliminary data that are relevant to the pilot clinical trial being proposed.
What evidence is required to support a Phase I or Phase II clinical trial application?
For Phase I or Phase II trials, both a clear scientific rationale and preliminary data relevant to the proposed trial are required.
If my project is preclinical, can I still apply to this award?
No. Preclinical projects are directed to other NFRP award mechanisms offered in the same fiscal year rather than this clinical trial-specific mechanism.
What is the Funding Opportunity Number for this award?
The Funding Opportunity Number listed for this archived announcement is W81XWH-15-NFRP-CTA.
What type of funding is this categorized as?
It was categorized as discretionary funding.
What funding instrument types are available under this opportunity?
The funding instrument types include a cooperative agreement and a grant.
What CFDA listing is associated with this opportunity?
The opportunity falls under CFDA 12.420, Military Medical Research and Development (Department of Defense medical research and development).
How much total funding was estimated for this opportunity?
The total estimated funding was $2,880,000.
How many awards were expected to be made?
The announcement indicated an expectation of two awards.
Is cost sharing or matching required?
No. There was no cost sharing or matching requirement stated.
Who was eligible to apply?
Eligibility was described as unrestricted (open to any type of entity), subject to any additional clarifications included in the full text of the announcement.
When was this opportunity posted and when did it close?
The posted date was May 6, 2015. The original and final closing date was July 27, 2015.
Is this announcement current or archived?
This announcement was archived on August 26, 2015.
Where can applicants find human-subjects guidance specific to this program?
Applicants were pointed to a Human Subject Resource Document available through eBRAP at https://ebrap.org/eBRAP/public/Program.htm.
Who can I contact for help accessing the full announcement?
The contact listed for help accessing the full announcement was the CDMRP Help Desk at 301-682-5507.
Which organizations administer this funding opportunity?
The opportunity is a DoD funding announcement run through USAMRAA under the Neurofibromatosis Research Program (NFRP).
What is the main emphasis of the program in terms of impact?
The emphasis is on studies that can move the NF field forward in a practical, patient-facing way and are positioned to produce clinically relevant evidence, rather than early laboratory or animal work.
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