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Orthotics and Prosthetics Outcomes

NEWS RELEASE

Released: January 7, 2021

Defense Health Program
Department of Defense Orthotics and Prosthetics Outcomes Research Program
Anticipated Funding Opportunities for Fiscal Year 2021 (FY21)

Although the Fiscal Year 2021 (FY21) Defense Appropriations Bill has been signed into law, the FY21 appropriation for the Department of Defense Orthotics and Prosthetics Outcomes Research Program (OPORP) is contingent upon the outcome of a pending rescissions request. The OPORP 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 Defense Appropriations Act is anticipated to provide funding to the Department of Defense OPORP to support supports research that evaluates orthoses and/or prostheses using patient-centric outcomes relevant to Service Members and military beneficiaries, Veterans, and other individuals with limb loss and/or limb impairment. 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). 

Subject to the FY21 Congressional appropriation for OPORP funding, FY21 OPORP 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. 

The vision of the OPORP is to ensure the highest possible quality of life for our injured Service members, Veterans, and beneficiaries through the advancement of knowledge in orthotics- and prosthetics-related practice. The OPORP supports research on outcomes-based best practices through analysis of prosthetic and/or orthotic device options that are currently available, and not on the development of new devices or the improvement of an existing technology. Projects involving spinal orthoses, pediatric populations, or analysis of short-term use devices will not be considered for the FY21 OPORP.

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

  • Orthoses or Prostheses Form: Optimize 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. 
  • Orthoses or Prostheses Fit: Optimize patient outcomes related to the human-device interface through the analysis of variables in currently available clinical options that facilitate fit-related metrics such as comfort, limb health, and/or usability. 
  • Orthoses or Prostheses Control: Optimize patient outcomes through the analysis of variables related to currently available device mechanisms such as device control, sensors, and passive or active response. 
  • Orthoses or Prostheses Function: Optimize patient outcomes by analyzing device-inclusive care protocols and interventions to inform best practices such as evaluation and prescription, timing of interventions, community functioning, and multidisciplinary approaches to clinical care in order to understand short- and long-term outcomes with respect to activities of daily living and other real-world activities.

Award Mechanism Eligibility Key Mechanism Elements Funding
Clinical Research Award Independent investigators at all academic levels (or equivalent).
  • Supports clinical research but not clinical trials.
  • Proposed clinical research projects may include (but are not limited to) methodologies and designs such as surveys, observational studies, or meta-analysis and systematic reviews that focus on outcomes related to the FY21 OPORP focus areas.
  • Funding Level 1 supports pilot research studies that have the potential to make significant advancements toward clinical translation. Preliminary data are encouraged but not required for this Funding Level.
  • Funding Level 2 supports research that has the potential to make significant advancements toward clinical translation. Proposed projects may include large-scale studies that, if successful, will produce high-quality outcomes that provide strong support for evidence-based practice and/or have the potential to drive changes in clinical practice. Preliminary data and/or published data from the literature that are relevant to the orthotic and/or prosthetic device outcomes and support the rationale for the proposed research are required.
  • Preclinical studies using animals are not allowed.
 Funding Level 1
  • Maximum funding of $350,000 for total costs (direct plus indirect costs).
  • Maximum period of performance is 2 years.

Funding Level 2

  • Maximum funding of $2 million (M) for total costs (direct plus indirect costs).
  • Maximum period of performance is 4 years.
Clinical Trial Award Independent investigators at all academic levels (or equivalent).
  • Supports clinical trials with the potential to have a significant impact on improving the health and well-being of individuals with limb loss and/or limb impairment.
  • Funding Level 1 supports pilot and early stage clinical trials that are exploratory and involve limited human exposure (e.g., small sample size) with the potential to make significant advancements toward clinical translation. Preliminary data are encouraged but not required for this Funding Level.
  • Funding Level 2 supports large clinical trials with the potential to make significant advancements toward clinical translation. Proposed projects may include large-scale trials that, if successful, will produce high-quality outcomes with robust, statistically relevant participant numbers to provide strong, definitive support for evidence-based practice and/or have the potential to drive changes in clinical practice. Pragmatic clinical studies, randomized controlled trials, and comparative effectiveness studies are welcome and encouraged. Preliminary data relevant to the proposed clinical trial are required.
  • Preclinical research is not allowed.
 Funding Level 1
  • Maximum funding of $350,000 for total costs (direct plus indirect costs).
  • Maximum period of performance is 3 years.

Funding Level 2

  • Maximum funding of $4 million (M) for total costs (direct 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 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 OPORP or other CDMRP-administered programs, please visit the CDMRP website (https://cdmrp.health.mil).

Point of Contact:

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


Last updated Thursday, December 5, 2024