Opportunity Information: Apply for W81XWH 16 PRORP ARA

  • The Department of Defense, Dept. of the Army -- USAMRAA in the science and technology and other research and development sector is offering a public funding opportunity titled "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.
  • This funding opportunity was created on Aug 02, 2016.
  • Applicants must submit their applications by Dec 07, 2016. (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 5 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.
Apply for W81XWH 16 PRORP ARA

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Opportunity Summary:

The Peer Reviewed Orthopaedic Applied Research Award (PRORP ARA) is a Department of Defense funding opportunity administered through the U.S. Army Medical Research Acquisition Activity (USAMRAA) under the Congressionally Directed Medical Research Programs. Its purpose is to support applied orthopaedic research that can improve treatment outcomes and help restore function for Service members who have sustained musculoskeletal injuries during combat or combat-related activities. While the program is driven by military needs, it is also intended that the resulting advances, tools, or approaches would translate to benefits for civilians with similar injuries.

A defining feature of this award is that it is strictly focused on applied research rather than fundamental basic science. In this context, applied research means taking existing ideas, concepts, and early findings and pushing them toward practical solutions that can be evaluated for technical feasibility and readiness for translation. The solicitation emphasizes work that could lead to tangible health-related outputs, such as promising knowledge products, pharmacologic agents, biologics, devices or systems, rehabilitation and behavioral interventions, diagnostic or therapeutic techniques, clinical guidance, or other emerging approaches and technologies. Projects can range from small to large in scope, but they are expected to produce results that position a product or approach for future human testing and continued movement toward clinical use.

To align with program intent, applicants must anchor their proposal to one, and only one, of the FY16 PRORP Focus Areas referenced in the announcement (these focus areas are listed in the full solicitation). This requirement is treated as a hard constraint, meaning proposals that try to span multiple focus areas or do not clearly map to a single one are unlikely to be considered responsive. The award is meant to mature a solution along the translational pipeline, so competitive proposals are expected to show a clear path from the proposed work to a practical next step, such as readiness for a clinical study, a regulatory interaction, or another milestone that moves the innovation closer to implementation.

The program also requires preliminary support for the proposed direction. Applicants must include preliminary and/or published data relevant to the research question, and they must demonstrate logical reasoning that connects prior evidence to the planned approach. The announcement highlights the need for a strong scientific rationale and a well-formulated, testable hypothesis grounded in a critical review and analysis of the literature. In other words, this mechanism is not designed for speculative concepts without supporting evidence; it is designed for ideas that already have some traction and now need focused applied work to reduce risk and demonstrate feasibility.

Examples of activities that fit this mechanism include refining concepts into workable solutions and testing technical feasibility; evaluating, maturing, and down-selecting product candidates (including drugs, biologic constructs, and devices or systems) using in vitro and/or in vivo studies; and conducting preparatory work that would support a future clinical trial or regulatory submission. This makes the award particularly relevant for teams that are past the earliest discovery stage but not yet ready to run a human trial, and who need resources to optimize a candidate, generate performance data, complete key preclinical evaluations, or assemble documentation and planning that enables the next translational leap.

At the same time, the solicitation draws a firm boundary around what the award cannot fund. Clinical trials are explicitly not allowed under this mechanism. The announcement defines a clinical trial as prospective accrual of human subjects in which an intervention is tested to measure outcomes related to exploratory information, safety, effectiveness, and/or efficacy, where the outcome represents a direct effect of the intervention on the human subject. Applicants who intend to conduct this kind of prospective interventional human study are directed instead to the separate FY16 PRORP Clinical Trial Award opportunity (W81XWH-16-PRORP-CTA). The funding notice also points applicants to the eBRAP Human Subject Resource Document for guidance on distinguishing clinical research from a clinical trial, which matters for determining whether a proposed human-subjects component is allowable.

From an administrative standpoint, this opportunity was posted as Funding Opportunity Number W81XWH-16-PRORP-ARA, categorized as discretionary funding, and offered through either grants or cooperative agreements. It falls under the Science and Technology and other Research and Development activity category and is associated with CFDA number 12.420. Eligibility is described as unrestricted, meaning it is open to a broad range of applicant organization types, subject to any additional eligibility notes contained in the full announcement. The opportunity was created on August 2, 2016, with an original closing date of December 7, 2016, and it projected approximately five awards. The award ceiling is listed as 0 in the source data, which typically indicates that a specific maximum was not captured in that field and applicants would need to consult the full solicitation for budget constraints, expectations, and any limits or negotiation details.

Overall, the PRORP Applied Research Award is aimed at translating orthopaedic and musculoskeletal injury research into actionable solutions for warfighter care, with an emphasis on feasibility, product maturation, and readiness for eventual clinical translation. Strong applications under this mechanism are typically those that commit to a single program focus area, present credible preliminary evidence, propose well-justified applied studies (often preclinical or development-oriented), and deliver clear deliverables that set up the next step toward human evaluation, without crossing into conducting a clinical trial within the award period.

Peer Reviewed Orthopaedic Applied Research Award (PRORP ARA) - FAQs

What is the PRORP Applied Research Award (ARA)?

The Peer Reviewed Orthopaedic Applied Research Award (PRORP ARA) is a Department of Defense funding opportunity administered through the U.S. Army Medical Research Acquisition Activity (USAMRAA) under the Congressionally Directed Medical Research Programs. It supports applied orthopaedic research intended to improve treatment outcomes and help restore function for Service members with musculoskeletal injuries sustained during combat or combat-related activities.

What is the main purpose of this award?

The purpose is to move orthopaedic and musculoskeletal injury solutions closer to practical use by supporting applied research that demonstrates technical feasibility and readiness for translation. The program is driven by military needs, with the intent that resulting advances may also benefit civilians with similar injuries.

Is this award for basic science or applied research?

This mechanism is strictly focused on applied research, not fundamental basic science. It is intended to take existing concepts and early findings and push them toward practical solutions that can be matured and evaluated for feasibility and translational readiness.

What kinds of outputs or deliverables does the program encourage?

The solicitation emphasizes tangible, health-related outputs such as knowledge products, pharmacologic agents, biologics, devices or systems, rehabilitation and behavioral interventions, diagnostic or therapeutic techniques, clinical guidance, and other emerging approaches or technologies.

How mature should a project be to be competitive?

Projects are generally expected to be past the earliest discovery stage and positioned to generate results that set up a practical next step toward human testing or clinical use. Competitive proposals typically show a clear path to a milestone such as readiness for a clinical study, a regulatory interaction, or another defined translational step.

Do applicants need to select a PRORP Focus Area?

Yes. Applicants must anchor the proposal to one, and only one, of the FY16 PRORP Focus Areas referenced in the announcement. Proposals that span multiple focus areas or do not clearly map to a single focus area are unlikely to be considered responsive.

Are preliminary data required?

Yes. Applicants must include preliminary and/or published data relevant to the research question, along with logical reasoning that connects existing evidence to the planned approach. The mechanism is not intended for purely speculative ideas without supporting evidence.

What does the program expect in terms of scientific rationale?

The solicitation calls for a strong scientific rationale and a well-formulated, testable hypothesis grounded in a critical review and analysis of the literature. The application should clearly explain how prior findings support the proposed applied work.

What are examples of activities that fit this award?

Examples listed include refining concepts into workable solutions and testing technical feasibility; evaluating, maturing, and down-selecting product candidates (including drugs, biologic constructs, and devices or systems) using in vitro and/or in vivo studies; and conducting preparatory work that would support a future clinical trial or regulatory submission.

Can this award fund a clinical trial?

No. Clinical trials are explicitly not allowed under this mechanism.

How does the announcement define a clinical trial for this award?

A clinical trial is defined as prospective accrual of human subjects in which an intervention is tested to measure outcomes related to exploratory information, safety, effectiveness, and/or efficacy, where the outcome represents a direct effect of the intervention on the human subject.

If a project includes a clinical trial, is there another PRORP mechanism to use?

Yes. Applicants intending to conduct a prospective interventional human study are directed to the separate FY16 PRORP Clinical Trial Award opportunity (W81XWH-16-PRORP-CTA).

Is there guidance for distinguishing clinical research from a clinical trial?

Yes. The notice points applicants to the eBRAP Human Subject Resource Document for guidance on distinguishing clinical research from a clinical trial, which matters for determining whether a proposed human-subjects component is allowable.

What is the Funding Opportunity Number for this award?

The Funding Opportunity Number listed is W81XWH-16-PRORP-ARA.

Which agency administers this opportunity?

It is administered through the U.S. Army Medical Research Acquisition Activity (USAMRAA) under the Congressionally Directed Medical Research Programs.

What type of funding instrument is used?

The opportunity is offered through either grants or cooperative agreements.

How is this opportunity categorized?

It is categorized as discretionary funding and falls under the Science and Technology and other Research and Development activity category.

What CFDA number is associated with this opportunity?

The opportunity is associated with CFDA number 12.420.

Who is eligible to apply?

Eligibility is described as unrestricted, meaning it is open to a broad range of applicant organization types, subject to any additional eligibility notes contained in the full announcement.

When was the opportunity posted and when did it close?

The opportunity was created on August 2, 2016, with an original closing date of December 7, 2016.

How many awards were expected to be made?

The opportunity projected approximately five awards.

Is there a maximum award amount listed?

The source data lists an award ceiling of 0, which typically indicates a specific maximum was not captured in that field. Applicants would need to consult the full solicitation for budget constraints, expectations, and any limits or negotiation details.

What is the overall focus of the PRORP ARA in plain terms?

It is aimed at translating orthopaedic and musculoskeletal injury research into actionable solutions for warfighter care by funding applied studies that reduce risk, demonstrate feasibility, mature a candidate or approach, and set up the next step toward eventual human evaluation, without conducting a clinical trial during the award.

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