The Fiscal Year 2019 (FY19) Defense Appropriation provides $30 million (M) to the Department of Defense Peer Reviewed Orthopaedic Research Program (PRORP) to support the most significant gaps in care for the leading burden of injury and for facilitating return to duty by funding innovative, high-impact, clinically relevant research to advance optimal treatment and rehabilitation from musculoskeletal injuries sustained during combat and combat-related activities. 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 Materiel Command (USAMRMC).
The PRORP is providing the information in this pre-announcement to allow investigators time to plan and develop applications. FY19 PRORP Program Announcements and General Application Instructions for the following award mechanisms are anticipated to be posted on the Grants.gov website by June 2019. Pre-application and application deadlines will be available when the Program Announcements are released. This pre-announcement should not be construed as an obligation by the Government.
The PRORP will solicit research applications that specifically address at least one of the following FY19 Focus Areas:
- 1. Compartment Syndrome Models: Diagnostic and/or treatment strategies developed in a large animal model that replicates compartment syndrome. Model system should be clinically relevant and scientifically reproducible.
- 2. Limb Stabilization and Protection: Development of rapid limb stabilization and novel wound protectants for severely wounded limbs to enable transport at the point of need.
- 3. Retention on Duty Strategies: Development and/or optimization 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.)
- 4. Skin-implant Interface: Identification of best practices to address infection at the skin-implant interface for osseointegrated prosthetic limbs.
- 5. Translation of Early Findings: Translation of early research findings in orthopaedic surgical care topic areas (volumetric muscle loss, compartment syndrome, and soft tissue trauma) to move the research toward clinical trials and clinical practice.
- 6. Tissue Regeneration Therapeutics: Development of advanced tissue regeneration therapeutics in nerve, muscle, and/or composite tissue for the restoration of traumatically injured extremities (excludes isolated bone tissue engineering studies).
The following FY19 PRORP award mechanisms are planned for release (note that Focus Area requirements vary by award mechanism):
https://cdmrp.army.mil/pubs/press/2019/19prorppreann
Applied Research Award
Independent investigators at all academic levels (or equivalent) are eligible to submit applications.
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· 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 the following FY19 PRORP Focus Areas:
- o Compartment Syndrome Models
- o Limb Stabilization and Protection
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- Retention on Duty Strategies
· Maximum funding of $750,000 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.
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· 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.
· 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 FY19 PRORP Focus Areas:
- o Limb Stabilization and Protection
- o Retention on Duty Strategies
- o Translation of Early Findings
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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.
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· Maximum funding of $2.5M for total costs. ($3M maximum total costs if requesting the Rehabilitation Option.)
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- · Maximum period of performance is 4 years.
Clinical Translational Research Award
Independent investigators at all academic levels (or equivalent) are eligible to submit applications.
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· 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.
· 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 the following FY19 PRORP Focus Areas:
- o Retention on Duty Strategies
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- Tissue Regeneration Therapeutics
· Maximum funding of $2M for total costs.
· 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 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 USAMRMC 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
usarmy.detrick.medcom-cdmrp.mbx.cdmrp-public-affairs@mail.mil
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