Defense Health Program Department of Defense Peer Reviewed Orthopaedic Research Program Anticipated Funding Opportunities for Fiscal Year 2020 (FY20)

Defense Health Program
Department of Defense 
Peer Reviewed Orthopaedic Research Program

Anticipated Funding Opportunities for Fiscal Year 2020 (FY20)

 

The FY20 Defense Appropriations Act provides funding to the Department of Defense Peer Reviewed Orthopaedic Research Program (PRORP) to support innovative, 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 FY20 funding opportunities.  This pre-announcement should not be construed as an obligation by the Government.  The FY20 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 FY20 PRORP must address one or more of the following FY20 Focus Areas:

1.     Compartment Syndrome: Novel treatment strategies to improve current diagnoses for compartment syndrome. Alternatives to intracompartmental pressure measurements are encouraged.

2.     Limb Stabilization and Protection: Development and/or clinical assessment of rapid limb stabilization and novel wound protectants for severely wounded limbs to enable transport at the point of need.

3.     Orthotic Devices: Refinement of high-performance novel orthotic devices designed to enhance whole person performance and decrease pain in patients with limb salvage and impairment.

4.     Osseointegration: Identification of best practices to address infection, rejection, and/or failure of percutaneous osseointegrated prosthetic limbs.

5.     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 and the standard of care must be specified, as applicable.

o   Point of Injury: Battlefield-feasible strategies that can be utilized at or near the point of injury to allow an injured Service member to remain on duty and stay on mission without the need for immediate evacuation.

o   Point of Duty: Strategies that can be utilized along the continuum of care to allow an injured Service member to return to duty without separation from Service.

6.     Tissue Regeneration Therapeutics: Development of advanced tissue regeneration therapeutics in nerve, muscle (to include volumetric muscle loss), and/or composite tissue for the restoration of traumatically injured extremities.  Isolated bone or cartilage tissue engineering studies are excluded.

7.     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.

o   Soft Tissue Trauma: Strategies to develop and/or identify musculoskeletal extremity soft tissue trauma treatments for anterior cruciate ligament (ACL) or shoulder instability only, to optimize return to duty, work, or reintegration.

o   Fracture-Related Infection: Strategies to decrease the burden of fracture-related infections (may include prevention, early detection, or improved eradication).  Alternatives to systemic and/or local antibiotic delivery are encouraged. 

https://cdmrp.army.mil/pubs/press/2020/20prorppreann

 

Applied Research Award

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

  • Pre-application is required; full 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 FY20 PRORP Focus Areas:

o    Limb Stabilization and Protection

o    Retention Strategies

o    Osseointegration

  • Maximum funding of $725,000 for total costs (direct plus indirect costs).
  • Maximum period of performance is 3 years.

Clinical Trial Award

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

  • Pre-application is required; full 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 FY20 PRORP Focus Areas:

o    Limb Stabilization and Protection

o    Retention Strategies

o    Translation of Early Findings

Applications submitted to the Translation of Early Findings (soft tissue trauma only) Focus Area may elect a Rehabilitation Option, which provides a higher funding maximum for surgical intervention studies that propose an integrative rehabilitation component.

  • Maximum funding of $2.25M 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.

  • Pre-application is required; full 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 FY19 PRORP Focus Areas:

o    Retention Strategies

o    Tissue Regeneration Therapeutics

o    Compartment Syndrome

o    Osseointegration

o    Orthotic Devices

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

Point of Contact:

CDMRP Public Affairs
301-619-9783