DEPARTMENT OF DEFENSE - CONGRESSIONALLY DIRECTED MEDICAL RESEARCH PROGRAMS

NEWS RELEASE

Released: February 1, 2021

Defense Health Program
Department of Defense Peer Reviewed Orthopaedic Research Program
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 PRORP is providing the information in this pre-announcement to allow investigators time to plan and develop ideas for submission to the anticipated FY21 funding opportunities. This pre-announcement should not be construed as an obligation by the Government. The FY21 PRORP Program Announcements and General Application Instructions for the following award mechanisms will be posted on the Grants.gov website. Pre-application and application deadlines will be available when the Program Announcements are released.

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.
Award Mechanism Eligibility Key Mechanism Elements Funding
Applied Research Award Independent investigators at all academic levels (or equivalent) are eligible to submit applications.
  • Submission of a preproposal is required; application submission is by invitation only.
  • Supports applied research applications focused on advancing optimal treatment and restoration of function for military personnel with musculoskeletal injuries sustained during combat or combat-related activities.
  • Proposed research should be supported by preliminary data and have the potential to make significant advancements toward clinical translation.
  • Clinical trials are not allowed under this award mechanism.
  • Applications must address one of the following FY21 PRORP Focus Areas:
    • Limb Stabilization and Protection
    • Retention Strategies
    • Osseointegration
    • Maximum funding of $725,000 for total costs (direct plus indirect costs).
    • Maximum period of performance is years. 
    Clinical Trial Award Independent investigators at all academic levels (or equivalent) are eligible to submit applications.
  • Submission of a preproposal is required; application submission is by invitation only.
  • Supports rapid implementation of clinical trials with the potential to have a major impact on military combat-related orthopaedic injuries or non-battle injuries that significantly impact unit readiness and return-to-duty/work rates.
  • Funding must support a clinical trial and may not be used for preclinical research studies.
  • Collaboration with military researchers and clinicians is encouraged, but not required.
  • 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 the following FY21 PRORP Focus Areas:
    • Limb Stabilization and Protection
    • Retention Strategies
    • Translation of Early Findings
  • Applications submitted to the Translation of Early Findings - Soft Tissue Trauma Focus Area (only) may elect a Rehabilitation Option, which provides a higher funding maximum for surgical intervention studies that propose an integrative rehabilitation component.
    • Maximum funding of $2.25 Million for total costs. ($2.75M maximum total costs if requesting the Rehabilitation Option.)
    • Maximum period of performance is years. 
    Clinical Translational Research Award Independent investigators at all academic levels (or equivalent) are eligible to submit applications.
  • Submission of a preproposal is required; application submission is by invitation only.
  • Supports high-impact and/or emerging 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 or published data relevant to the proposed research project are required.
  • Collaboration with military researchers and clinicians is encouraged, but not 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 PRARP Overarching Challenges:
    • Retention Strategies
    • Compartment Syndrome
    • Osseointegration
    • Prosthetic and Orthotic Devices
    • Tissue Regeneration Therapeutics
    • Maximum funding of $1.5M for total costs.
    • Maximum period of performance is 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 that will be 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. 

    Submission deadlines are not available until the Program Announcements are released. For email notification when Program Announcements are released, subscribe to program-specific news and updates under “Email Subscriptions” on the eBRAP homepage at https://eBRAP.org. For more information about the PRARP or other CDMRP-administered programs, please visit the CDMRP website (https://cdmrp.army.mil).

    Point of Contact:

    CDMRP Public Affairs
    301-619-9783
    usarmy.detrick.medcom-cdmrp.mbx.cdmrp-public-affairs@mail.mil


    Last updated Monday, February 1, 2021