Defense Health Program Department of Defense Peer Reviewed Orthopaedic Research Program

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Anticipated Funding Opportunities for Fiscal Year 2021 (FY21)

The FY21 Defense Appropriations Act provides funding to the Department of Defense Peer Reviewed Orthopaedic Research Program (PRORP) to support high-impact, clinically-relevant research to advance optimal treatment and rehabilitation from musculoskeletal injuries. As directed by the Office of the Assistant Secretary of Defense for Health Affairs, the Defense Health Agency J9, Research and Development Directorate manages the Defense Health Program (DHP) Research, Development, Test, and Evaluation (RDT&E) appropriation.  The managing agent for the anticipated Program Announcements/Funding Opportunities is the Congressionally Directed Medical Research Programs (CDMRP) at the U.S. Army Medical Research and Development Command (USAMRDC).

The FY21 PRORP Program Announcements and General Application Instructions for the following award mechanisms are posted on the Grants.gov website. 

Applications submitted to the FY21 PRORP must address one or more of the following focus areas:

  • Compartment Syndrome: Novel treatment strategies to improve current diagnoses for compartment syndrome. Alternatives to intracompartmental pressure measurements are encouraged.
  • Limb Stabilization and Protection: Development of rapid limb stabilization and novel wound protectants for severely or critically wounded limbs to enable prolonged care and eventual transport to the point of definitive treatment.
  • Osseointegration: Identification of best practices to address infection, rejection, and/or failure of percutaneous osseointegrated prosthetic limbs.
  • Prosthetic and Orthotic Devices: Development of high-performance novel prosthetic or orthotic devices designed to enhance whole person performance and decrease pain in patients with amputation and limb salvage, and impairment. Multicenter studies which focus on transfemoral amputees are encouraged.
  • Retention Strategies: Development, optimization, and/or validation of battlefield-feasible diagnostic capabilities, decision support tools, interventions, and/or rehabilitation strategies that can facilitate retention on duty for common combat-related musculoskeletal injuries.  Biomarker studies are excluded. The current standard of care must be noted. The rehabilitation strategy to be used in the proposed study must be specified, as applicable.
    • Battlefield Care: Strategies that can be utilized at or near the point of injury to allow an injured Service member to remain on the battlefield or on mission without the need for evacuation. Treatment strategies that allow return to mission effectiveness within 30 days will be considered.
    • Return to Duty: Treatment strategies that can be utilized along the continuum of care and enable return to duty of the Service member within one year of injury.
  • Tissue Regeneration Therapeutics: Development of advanced tissue regeneration therapeutics in nerve, muscle, and/or composite tissue for the restoration of traumatically injured extremities. Isolated bone or cartilage tissue engineering studies are excluded. Early clinical feasibility studies involving volumetric muscle loss are encouraged.
  • Translation of Early Findings: Translation of early research findings in the orthopaedic surgical care topic areas listed below to move the research toward clinical trials and clinical practice.
    • Soft Tissue Trauma: Strategies to develop and/or identify musculoskeletal extremity soft tissue trauma treatments for shoulder, knee, or chronic ankle instability and sequela only, to optimize return to duty, work, or reintegration.
    • Fracture-Related Infection: Strategies to decrease the burden of fracture-related infections (may include prevention, early detection, or improved eradication). Alternatives to systemic antibiotic delivery are encouraged. Novel approaches that improve the current standard of treatment to prevent fracture-related infections are encouraged. 

https://cdmrp.army.mil/funding/prorp

Applied Research Award – Preproposal due May 27, 2021

Independent investigators at all academic levels (or equivalent)

Supports applied research applications focused on advancing optimal treatment and restoration of function for individuals with musculoskeletal injuries sustained during combat, combat-related activities, and non-battle injuries that impact unit readiness and the ability to return to duty/work.

• Proposed research should be supported by preliminary and/or published data and have the potential to make significant advancements toward clinical translation.

• Clinical research and clinical trials are not allowed under this award mechanism.

• Applications must address one of the following FY21 PRORP ARA Focus Areas:

○ Limb Stabilization and Protection

○ Retention Strategies

− Battlefield Care

− Return to Duty

○ Osseointegration

• Pre-application submission is required; application submission is by invitation only.

The maximum allowable funding for the entire period of performance is $725,000 for total costs.

• Indirect costs may be proposed in accordance with the institution’s negotiated rate agreement.

• The maximum period of performance is 3 years.

Clinical Trial Award – Preproposal due May 27, 2021

Independent investigators at all academic levels (or equivalent) are eligible to submit applications.

•Supports rapid implementation of clinical trials with the potential to have a significant impact on the treatment or management of military combat-related orthopaedic injuries or non-battle injuries that significantly impact unit readiness and return to duty/work rates.

•Investigational New Drug or Investigational Device Exemption applications, if needed, should be submitted to the Food and Drug Administration within 6 months of the award date.

•Applications must address one of the following FY21 PRORP CTA Focus Areas:

○Limb Stabilization and Protection

○Retention Strategies

−Battlefield Care

−Return to Duty

○Translation of Early Findings

−Soft Tissue Trauma

−Fracture-Related Infection

•Applications submitted to address the Translation of Early Findings – Soft Tissue Trauma Focus Area and include the Rehabilitation Option are eligible for Research Level 2.

•All applications, regardless of the selected Focus Area, are eligible for Research Level 1.

•Funding must support a clinical trial and may not be used for animal or preclinical research studies.

•Pre-application submission is required; application submission is by invitation only.

Research Level 1:

•The maximum allowable funding for the entire period of performance is$2.25 million (M) for total costs.

•Indirect costs may be proposed in accordance with the institution’s negotiated rate agreement.

•The maximum period of performance is 4 years.

Research Level 2:

•The maximum allowable funding for the entire period of performance is$2.75M for total costs.

•Indirect costs may be proposed in accordance with the institution’s negotiated rate agreement.

•The maximum period of performance is 4 years.

Clinical Translational Research Award – Preproposal due May 27, 2021

Independent investigators at all academic levels (or equivalent)

•Supports high-impact and/or new/emerging clinical research that may or may not be ready for a full-scale randomized controlled clinical trial.

•Funding must support clinical research studies involving humans.

•Preliminary data relevant to the proposed research project are required.

•Investigational New Drug or Investigational

Device Exemption applications, if needed, should be submitted to the Food and Drug Administration within 12 months of the award date

•Applications must address one of the following FY21 PRORP CTRA Focus Areas:

○Retention Strategies

−Battlefield Care

−Return to Duty

○Tissue Regeneration Therapeutics

○Compartment Syndrome

○Osseointegration

○Prosthetic and Orthotic Devices

•Pre-application submission is required; application submission is by invitation only.

•The maximum allowable funding for the entire period of performance is$1.5M for total costs.

•Indirect costs may be proposed in accordance with the institution’s negotiated rate agreement.

•The maximum period of performance is 4 years

A pre-application is required and must be submitted through the electronic Biomedical Research Application Portal (eBRAP) at https://eBRAP.org prior to the pre-application deadline.  All applications must conform to the final Program Announcements and General Application Instructions available for electronic downloading from the Grants.gov website.  The application package containing the required forms for each award mechanism will also be found on Grants.gov.  A listing of all CDMRP and other USAMRDC extramural funding opportunities can be obtained on the Grants.gov website by performing a basic search using CFDA Number 12.420. 

For more information about the PRORP or other CDMRP-administered programs, please visit the CDMRP website (https://cdmrp.army.mil).