Opportunity Information: Apply for W81XWH 15 PRORP ARA
Apply for W81XWH 15 PRORP ARA
- 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 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 Military Medical Research and Development.
- This funding opportunity was created on Jun 30, 2015 and posted on Jun 30, 2015.
- Applicants must submit their applications by Nov 19, 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 $3,000,000.00 to eligible and selected applicants.
- The number of recipients for this funding is limited to 4 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 Peer Reviewed Orthopaedic Applied Research Award (PRORP ARA; Funding Opportunity Number W81XWH-15-PRORP-ARA) is a U.S. Army Medical Research Acquisition Activity (USAMRAA) funding opportunity under the Congressionally Directed Medical Research Programs (CDMRP) that was introduced for the first time in FY2015. Its purpose is to support applied, translational orthopaedic research aimed at improving treatment and restoring function for Service members who have sustained musculoskeletal injuries during combat or combat-related activities. While the military need is the primary driver, the program also expects that successful advances will translate to meaningful benefits for civilian patients with similar injuries.
A central requirement is that proposed work must align with one of the FY15 PRORP ARA Focus Areas (the application has to explicitly address at least one). The award is not intended for fundamental basic research. In practical terms, projects should not be framed as open-ended investigations of underlying biological mechanisms without a clear pathway to a usable medical solution. Instead, the ARA is built for applied research that pushes promising concepts toward real-world use by refining and validating potential solutions, assessing feasibility, and generating the kind of evidence needed to justify the next step toward human testing.
The types of activities encouraged under this mechanism include maturing and de-risking candidate products or approaches, such as drugs, biologics, devices, systems, diagnostic or therapeutic techniques, rehabilitation and behavioral interventions, clinical guidance approaches, or other emerging technologies relevant to orthopaedic injury care and functional restoration. Examples of allowable work include in vitro and in vivo studies to evaluate and down-select among product candidates, nonclinical efficacy studies, and preclinical safety or toxicity studies that would be sufficient to support future regulatory steps such as an Investigational New Drug (IND) or Investigational Device Exemption (IDE) application. The announcement also supports preparatory efforts that set up a future clinical trial or regulatory submission, emphasizing that the end result should be a product, approach, or technology that is positioned for human testing after the award period.
At the same time, the program draws a clear line around what it will not fund: clinical trials. The opportunity defines a clinical trial as the prospective enrollment of human subjects where an intervention is tested for measurable outcomes tied to safety, effectiveness, or efficacy. If a project involves prospectively assigning an intervention to human participants and measuring outcomes as a direct effect of that intervention, it falls outside the scope of this ARA and would instead belong under the PRORP Clinical Trial Award mechanism. The announcement notes that some human-related work may be possible when it is not a clinical trial, such as certain human-use and/or observational studies, but applicants are expected to use CDMRP guidance to correctly distinguish clinical research from a clinical trial.
Competitiveness depends heavily on readiness and rigor. Preliminary data are required, and applicants are expected to include preliminary and/or published results directly relevant to the research question. Beyond having data, investigators must demonstrate logical reasoning, a strong scientific rationale, and a clearly formulated, testable hypothesis grounded in a critical review of the existing literature. In other words, proposals should show not only that an idea is interesting, but that it is supported, well-justified, and structured to produce actionable, decision-quality outcomes that move the work closer to clinical translation.
The program offers two funding levels based on project scope and maturity. Funding Level 1 is intended for research already supported by preliminary data that can make meaningful progress toward clinical translation; where appropriate, this level expects demonstration of efficacy in relevant in vivo models. Funding Level 2 is geared toward more advanced translational studies with the potential to lead to near-term clinical investigation, meaning the work should be at a later stage of development and closer to a clinical entry point, even though the award itself cannot pay for a clinical trial.
Administratively, this FY2015 opportunity was posted June 30, 2015, with an original (and final) closing date of November 19, 2015, and an archived date of December 19, 2015. The estimated total funding was $3,000,000, with an expectation of about 4 awards. The funding instrument types listed include grant and cooperative agreement, and the CFDA number is 12.420 (Military Medical Research and Development). Eligibility is described as unrestricted, meaning a wide range of entity types could apply, subject to any additional eligibility notes in the full announcement. There is no cost sharing or matching requirement indicated. For access issues, the opportunity directs applicants to the CDMRP Help Desk at 301-682-5507.
FAQs: DoD Peer Reviewed Orthopaedic Applied Research Award (PRORP ARA) - FY2015
What is the PRORP Applied Research Award (ARA)?
The Peer Reviewed Orthopaedic Applied Research Award (PRORP ARA) is a U.S. Department of Defense funding opportunity run by the U.S. Army Medical Research Acquisition Activity (USAMRAA) under the Congressionally Directed Medical Research Programs (CDMRP). It was introduced for the first time in FY2015 and supports applied, translational orthopaedic research.
What is the purpose of this award?
The purpose is to support applied, translational orthopaedic research aimed at improving treatment and restoring function for Service members who sustained musculoskeletal injuries during combat or combat-related activities. While military need is the primary driver, the program also expects successful advances to translate to meaningful benefits for civilian patients with similar injuries.
What kind of research does this funding opportunity prioritize?
This mechanism prioritizes applied research that moves promising concepts toward real-world use. That includes refining and validating potential solutions, assessing feasibility, and generating evidence needed to justify the next step toward human testing after the award period.
Is fundamental basic research allowed under this award?
No. The ARA is not intended for fundamental basic research. Projects should not be framed as open-ended investigations of underlying biological mechanisms without a clear pathway to a usable medical solution.
What are the required Focus Areas for FY15 PRORP ARA?
Proposed work must align with at least one of the FY15 PRORP ARA Focus Areas, and the application must explicitly address at least one Focus Area. (The specific Focus Areas are not listed in the information provided here.)
What types of products or approaches can be supported?
The announcement encourages work that matures and de-risks candidate products or approaches relevant to orthopaedic injury care and functional restoration, including drugs, biologics, devices, systems, diagnostic techniques, therapeutic techniques, rehabilitation interventions, behavioral interventions, clinical guidance approaches, or other emerging technologies.
What kinds of studies and activities are considered allowable?
Examples of allowable work include in vitro and in vivo studies to evaluate and down-select among product candidates, nonclinical efficacy studies, and preclinical safety or toxicity studies that would be sufficient to support future regulatory steps such as an Investigational New Drug (IND) or Investigational Device Exemption (IDE) application.
Does the ARA support preparing for a future clinical trial or regulatory submission?
Yes. The opportunity supports preparatory efforts that position a product, approach, or technology for human testing after the award period, including generating data and evidence needed for future regulatory submissions or setting up a future clinical trial (without funding the clinical trial itself).
Are clinical trials allowed under this award?
No. The program draws a clear line that it will not fund clinical trials under this mechanism. Projects that qualify as clinical trials are outside the scope of the ARA and belong under the PRORP Clinical Trial Award mechanism.
How does this opportunity define a clinical trial?
A clinical trial is defined as prospective enrollment of human subjects where an intervention is tested for measurable outcomes tied to safety, effectiveness, or efficacy. If a project prospectively assigns an intervention to human participants and measures outcomes as a direct effect of that intervention, it is considered a clinical trial and is not allowed under the ARA.
Is any human subjects work allowed if it is not a clinical trial?
Some human-related work may be possible when it is not a clinical trial, such as certain human-use and/or observational studies. Applicants are expected to use CDMRP guidance to correctly distinguish clinical research from a clinical trial.
Are preliminary data required?
Yes. Preliminary data are required, and applicants are expected to include preliminary and/or published results directly relevant to the research question.
What makes an application competitive for this award?
Competitiveness depends heavily on readiness and rigor. Beyond having preliminary data, investigators must demonstrate logical reasoning, a strong scientific rationale, and a clearly formulated, testable hypothesis grounded in a critical review of existing literature. Proposed outcomes should be actionable and decision-quality, moving the work closer to clinical translation.
What are the two funding levels described in the announcement?
The program offers two funding levels based on project scope and maturity: Funding Level 1 and Funding Level 2.
What is Funding Level 1 intended to support?
Funding Level 1 is intended for research already supported by preliminary data that can make meaningful progress toward clinical translation. Where appropriate, this level expects demonstration of efficacy in relevant in vivo models.
What is Funding Level 2 intended to support?
Funding Level 2 is geared toward more advanced translational studies with the potential to lead to near-term clinical investigation. The work should be at a later stage of development and closer to a clinical entry point, even though the award itself cannot pay for a clinical trial.
What is the Funding Opportunity Number for this program?
The Funding Opportunity Number is W81XWH-15-PRORP-ARA.
Who administers this funding opportunity?
This opportunity is administered by the U.S. Army Medical Research Acquisition Activity (USAMRAA) under CDMRP.
What types of funding instruments are used?
The funding instrument types listed are grant and cooperative agreement.
What is the CFDA number associated with this opportunity?
The CFDA number is 12.420 (Military Medical Research and Development).
How much total funding was estimated for FY2015?
The estimated total funding was $3,000,000.
How many awards were expected to be made?
The program expected to make about 4 awards.
When was this FY2015 opportunity posted and when did it close?
The opportunity was posted on June 30, 2015. The original (and final) closing date was November 19, 2015.
When was the opportunity archived?
The opportunity was archived on December 19, 2015.
Who is eligible to apply?
Eligibility is described as unrestricted, meaning a wide range of entity types could apply, subject to any additional eligibility notes in the full announcement.
Is cost sharing or matching required?
No cost sharing or matching requirement is indicated in the information provided.
Who should applicants contact for access issues or help?
For access issues, applicants are directed to the CDMRP Help Desk at 301-682-5507.
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