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Department of Defense Peer Reviewed Orthopaedic Research Program – Funding Opportunities for Fiscal Year 2019 (FY19)

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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).

FY19 PRORP Program Announcements and General Application Instructions for the following award mechanisms are posted on the Grants.gov. 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):

Additional information can be found here: https://cdmrp.army.mil/funding/prorp

  • Applied Research Award- Preproposal is due June 26, 2019
  • Independent investigators at all academic levels (or equivalent)
  • 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 o Retention on Duty Strategies o Skin Implant Interface
  • Maximum funding of $750,000 for total costs (direct plus indirect costs).
  • Maximum period of performance is 3 years.
  • Clinical Trial Award – Preproposal due June 26, 2029
  • Independent investigators at all academic levels (or equivalent) 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:
    • Limb Stabilization and Protection o Retention on Duty Strategies
    • Translation of Early Findings 
    • Volumetric Muscle Loss
    • Compartment Syndrome
    • Soft Tissue Trauma
  • Funding Level 1:
  • Maximum funding of $2.5M for total costs (includes direct and indirect costs)
  • Maximum period of performance is 4 years.
  • Funding Level 2:
  • (Translation of Early Findings – Soft Tissue Trauma Focus Area with Rehabilitation Option):
  • Maximum funding of $3M maximum total costs and indirect costs • Maximum period of performance is 4 years.
  • Clinical Translational Research Award – Preproposal due June 26, 2019
  • Independent investigators at all academic levels (or equivalent) 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 o Tissue Regeneration Therapeutics
  • Maximum funding of $2M for total costs (includes direct and indirect 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 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.

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).

Department of Defense Peer Reviewed Orthopaedic Research Program – Funding Opportunities for Fiscal Year 2018

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FY18 PRORP Program Announcements and General Application Instructions for the following award mechanisms are posted on Grants.gov. 

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 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).

The mission of the PRORP is to address the most significant gaps in care for the leading burden of injury 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. 

Prolonged Field Care (PFC) has been identified as the number one capability gap across the Army.  PFC includes field trauma care extended beyond doctrinal timelines until the patient can be transported from the point of injury to an appropriate level of care.  In order to address this gap and prepare the orthopaedic field for the next conflict or mass event, the FY18 PRORP has identified several orthopaedic areas of focus for funding that will support patient care closer to the point of injury and to allow patients to more quickly return to duty/work. 

The PRORP will solicit research applications that specifically address at least one of the following FY18 Focus Areas:

  • Animal Models – Develop animal models that replicate Prolonged Field Care-related injuries, including ischemia reperfusion injury and compartment syndrome.
  • Device Development – Develop offloading and stability devices (e.g., braces, casting) for ligamentous injuries, small extremity fractures, and /or other non-severe common battlefield musculoskeletal injuries for immediate return to duty.
  • Wound Infection – Evaluate and /or translate promising available clinical interventions in prevention and control of combat extremity wound infections (e.g., for long bone open fractures) to improve their durability to treat Service member injuries as close as possible to the point of injury.  Projects that further develop novel wound protectants for this population will also be considered.
  • Treatment Techniques and Outcomes – Develop and /or evaluate optimal non-surgical and /or surgical treatment strategies and intervention delivery parameters (e.g., frequency, intensity, time, and intervention type) to rapidly remediate duty-limiting  impairments, functional limitations, or barriers to full duty readiness following orthopedic injuries.  Interventions may include, but are not limited to:  combination therapies (simultaneous application of multiple treatment modalities), injections, dry needling, manual therapy, therapeutic exercise, or other techniques to return Service members to duty within 72 hours.
  • Surgical Care – Translate early research findings, in any of the below Surgical Care Areas, to humans.
    • Surgical Care Areas: Peripheral Nerve Injuries, Prevention of Heterotopic Ossification, Volumetric Muscle Loss, Extremity Fractures, Pelvic Ring Injuries, Compartment Syndrome, Gaps in Clinical Practice Guidelines (http://www.usaisr.amedd.army.mil/cpgs.html), Surgical Techniques to Optimize Gait, Soft Tissue Trauma, Osteoarthritis.
  • Surgical Techniques and Outcomes – Evaluate optimal surgical treatment strategies, tools, and delivery parameters to improve functional outcomes of Service members who have sustained orthopaedic injuries.  The proposed research should address at least one topic from the Surgical Care Areas (listed below), and strategies to return the patient to duty and potentially shorten recovery in theater.
    • Surgical Care Areas: Peripheral Nerve Injuries, Prevention of Heterotopic Ossification, Volumetric Muscle Loss, Extremity Fractures, Pelvic Ring Injuries, Compartment Syndrome, Gaps in Clinical Practice Guidelines (http://www.usaisr.amedd.army.mil/cpgs.html), Surgical Techniques to Optimize Gait, Soft Tissue Trauma, Osteoarthritis
  • Rehabilitation Techniques and Outcomes – Evaluate optimal rehabilitation treatment strategies, tools, and delivery parameters to improve functional outcomes for immediate return to duty of Service members who have sustained orthopaedic injuries.
  • Acute Pain – Evaluate promising available or emerging clinical interventions to control acute pain (e.g., analgesics, anti-inflammatory agents, nerve blocks) following orthopaedic injuries in the pre-hospital setting.  Projects that investigate a pathway to enhance non-physician capabilities to deliver rapid, long lasting, analgesia with minimal cognitive side effects in an austere environment are encouraged.
  • Improved Surgical Interventions – Develop or optimize orthopaedic surgical interventions to support their use in the pre-hospital environment.
  • Tissue Regeneration:
    • Development and preclinical testing of therapies for volumetric muscle loss due to traumatically damaged tissues of the extremities.
    • Develop and /or evaluate regenerative medicine therapies (devices, drugs, biologics, and /or techniques) for traumatically injured tissues of the extremities.
    • Evaluate advanced regenerative medicine therapeutics for restoration of traumatically injured extremity tissues.

The following FY18 PRORP award mechanisms are released (note that Focus Area requirements vary by award mechanism):

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

Applied Research Award – Preproposal due July 30, 2018

  • 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 the following FY18 PRORP Focus Areas:
    • Animal Models
    • Device Development
    • Wound Infection
    • Tissue Regeneration
  • Maximum funding of $750,000 for total costs.
  • Maximum period of performance is 3 years.

Clinical Trial Award – Preproposal due July 30, 2018

  • 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.
  • Studies that include active duty military or Veteran participants as all or a portion of the study population will be considered.
  • 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 FY18 PRORP Focus Areas:
    • Surgical Techniques and Outcomes
    • Rehabilitation Techniques and Outcomes
    • Acute Pain
    • Improved Surgical interventions
    • Tissue Regeneration
  • Maximum funding of $3 million (M) for direct costs (plus indirect costs).
  • Maximum period of performance is 4 years.

Clinical Translational Research Award – Preproposal due July 30, 2018

  • 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.
  • Studies that include active duty military or Veteran participants as all or a portion of the study population will be considered.
  • 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 FY18 PRORP Focus Areas:
    • Treatment Techniques and Outcomes
    • Wound Infection
    • Surgical Care
    • Tissue Regeneration
  • Maximum funding of $2M for direct costs (plus indirect 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 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 funding opportunities can be obtained on the Grants.gov website by performing a basic search using CFDA Number 12.420. 

Applications must be submitted through the Federal Government’s single-entry portal, Grants.gov.  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 (http://cdmrp.army.mil).

Point of Contact:

CDMRP Help Desk
301-682-5507
help@eBrap.org

 

Department of Defense Orthotics and Prosthetics Outcomes Research Program – Funding Opportunities for Fiscal Year 2018

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The FY18 Defense Appropriation provides $10 million (M) to the Department of Defense Orthotics and Prosthetics Outcomes Research Program (OPORP) to support research that evaluates the comparative effectiveness of orthotic and prosthetic clinical interventions using patient-centric outcomes for Service members and Veterans who have undergone limb amputation.  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 Research, Development, Test, and Evaluation 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 Materiel Command (USAMRMC).

FY18 OPORP Program Announcements and General Application Instructions for the following award mechanisms are posted on the Grants.gov. 

OPORP awards are focused on outcomes-based best practices through analysis of the merits of prosthetic and orthotic device options currently available, not on the development of new or the improvement of existing technology.  The intent of the awards is to generate clinically useful evidence that will enhance and optimize patient outcomes.

Focus Areas:  The OPORP will only consider applications that specifically address the critical needs of the Orthotics and Prosthetics Outcomes research community in one or more of the FY18 Focus Areas.  The OPORP will solicit research applications that address at least one of the following FY18 Focus Areas:

  • Orthotic or Prosthetic Device Form:  Understand patient outcomes through the analysis and characterization of variables related to the form of currently available clinical options such as device size, shape, material, and/or configurations.
  • Orthotic or Prosthetic Device Fit:  Understand patient outcomes related to human-device interface and component connection through the analysis of variables in currently available clinical options that facilitate fit-related metrics such as comfort and/or usability.
  • Orthotic or Prosthetic Device Function:  Understand patient outcomes through the analysis of variables related to currently available device function such as device control, sensors, and passive or active response with respect to activities of daily living and other real-world activities.

http://cdmrp.army.mil/funding/oporp

Clinical Research Award – Preproposal due August 6, 2018

  • Independent investigators at all academic levels (or equivalent)
  • Supports research that evaluates the comparative effectiveness of orthotic and/or prosthetic clinical interventions using patient-centric outcomes for Service members and Veterans with limb loss and/or limb impairment.
  • Proposed projects should be designed to provide outcomes data regarding orthotic and/or prosthetic devices and must include the anticipated effect on patient care metrics.
  • Collaboration among academia, industry, the DoD, and the Department of Veterans Affairs (VA) is highly encouraged, including longitudinal outcomes studies.
  • Applications submitted to the FY18 OPORP CRA must address one or more of the FY18 OPORP Focus Areas.
  • Animal studies are not allowed.
  • Clinical trials are not allowed.
  • Preproposal submission is required; application submission is by invitation only.
  • Funding Level 1:
    • Maximum funding of $350,000 for total costs (direct costs plus indirect costs).
    • Maximum period of performance is 2 years.
  • Funding Level 2:
    • Maximum funding of $1,500,000 for total costs (direct costs plus indirect costs).
    • Maximum period of performance is 4 years.

Clinical Trial Award – Preproposal due August 6, 2018

Independent investigators at all academic levels (or equivalent)

  • Supports rapid implementation of clinical trials with the potential to make significant impacts on improving health and well-being of Service members and Veterans with limb loss and/or limb deficit.
  • Supports research that evaluates the comparative effectiveness of orthotic and/or prosthetic clinical interventions using patient-centric outcomes.
  • Proposed projects should be designed to provide outcomes data regarding orthotic and/or prosthetic devices and must include the anticipated effect on patient care metrics.
  • Collaboration among academia, industry, the DoD, and the VA is highly encouraged, including longitudinal outcomes studies.
  • Applications submitted to the FY18 OPORP CTA must address one or more of the FY18 OPORP Focus Areas.
  • Preclinical research is not allowed.
  • Preproposal submission is required; application submission is by invitation only.
  • Preclinical research is not allowed.
  • Funding Level 1:
    • Maximum funding of $350,000 for total costs (direct costs plus indirect costs).
    • Maximum period of performance is 2 years.
  • Funding Level 2:
    • Maximum funding of $2,500,000 for total costs (direct costs plus indirect 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 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. 

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 OPORP or other CDMRP-administered programs, please visit the CDMRP website (http://cdmrp.army.mil).

Point of Contact:

CDMRP Help Desk
301-682-5507
help@eBrap.org

 

Department of Defense Psychological Health/Traumatic Brain Injury Research Program – Funding Opportunities for Fiscal Year 2018-2019 (FY18/19)

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The FY18 Defense Appropriation provides $125 million (M) to the Department of Defense Psychological Health/Traumatic Brain Injury Research Program (PH/TBIRP) to support critical traumatic brain injury (TBI)- and psychological health (PH)-related research and development efforts to benefit Service members, Veterans, and other beneficiaries of the military health system.  As directed by the Office of the Assistant Secretary of Defense for Health Affairs, the Defense Health Agency (DHA) J9, Research and Development Directorate, manages the Defense Health Program’s Research, Development, Test, and Evaluation appropriation.  The U.S. Army Medical Research and Materiel Command (USAMRMC) Congressionally Directed Medical Research Programs (CDMRP) provides execution management support for DHA research program areas, including the Joint Program Committee-8/Clinical and Rehabilitative Medicine Research Program (JPC-8/CRMRP).  The managing agent for this Program Announcement is the CDMRP with strategic oversight from the JPC-8/CRMRP.

The PH/TBIRP is providing the information in this pre-announcement to allow investigators time to plan and develop applications.  FY18/19 PH/TBIRP Complex TBI Rehabilitation Research (CTRR) Program Announcements and General Application Instructions for the following award mechanisms are anticipated to be posted on the Grants.gov website in June 2018.  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 FY18/19 PH/TBIRP will solicit research applications for the following CTRR Focus Areas:

Mechanisms of Recovery following isolated or cumulative TBI(s) in Service member-relevant injuries:  Clinical research in human subjects that measures physiologic responses to cognitive rehabilitation with the intent to better understand how rehabilitation remediates cognitive or sensorimotor deficits, and ultimately to optimize rehabilitation prescription.

Ecological Assessment:  Investigation of outcome measures focused on military-specific tasks that inform return-to-duty/participation decisions following rehabilitation in patients with TBI.

Cognitive Rehabilitation:  Evaluation of rehabilitation intervention effectiveness in remediating cognitive impairments and functional limitations after TBI.

http://cdmrp.army.mil/pubs/press/2018/18phtbipreann

CTRR – Clinical Research Award (CTRR-CRA)

  • Independent investigators at all academic levels (or equivalent)
  • Supports applied and translational research to advance the development of knowledge and materiel products for rehabilitation and restoration of function following TBI.
  • Supported research can include preclinical studies using human subjects or samples and observational or mechanistic clinical research studies.
  • Clinical trials are not allowed.
  • Preclinical research using animals is not allowed.
  • Must address one or more FY18/19 PH/TBIRP CTRR Focus Areas.
  • Preproposal is required; application submission is by invitation only.
  • Maximum funding of $2.0M for total costs (direct plus indirect costs).
  • Maximum period of performance is 3 years.

CTRR – Clinical Trial Award (CTRR-CTA)

  • Independent investigators at all academic levels (or equivalent)
  • Supports small, single-site, Phase I clinical trials to advance the development of knowledge and materiel products for rehabilitation and restoration of function following TBI in Service members, Veterans, and other individuals.
  • Interventions should be limited, existing, and manualized.  Studies may include seeking to optimize dosing in existing interventions.
  • Preclinical studies are not allowed.
  • Must address one or more FY18/19 PH/TBIRP CTRR Focus Areas.
  • Preproposal is required; application submission is by invitation only.
  • Maximum funding of $1.5M for total costs (direct plus indirect costs).
  • Maximum period of performance is 2 years.

CTRR – Clinical Trial Development Award (CTRR-CTDA)

  • Independent investigators at all academic levels (or equivalent)
  • Supports design and development of the necessary research resources that will serve as a foundation for investigator-initiated clinical trials as described above under CTRR – Clinical Trial Award (CTRR-CTA)
  • Final supporting studies required for approval of Investigational New Drug Applications/Investigational Device Exemptions (IND/IDE-enabling) are allowed.  Other preclinical studies are not allowed.
  • Clinical trials are not allowed within the period of performance of the CTRR-CTDA.
  • Must address one or more FY18/19 PH/TBIRP CTRR Focus Areas.
  • Preproposal is required; application submission is by invitation only.
  • Maximum funding of $200,000 for total costs (direct plus indirect costs).
  • Maximum period of performance is 1 year.

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 PH/TBIRP or other CDMRP-administered programs, please visit the CDMRP website (http://cdmrp.army.mil).

Point of Contact:

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