Department of Defense Peer Reviewed Orthopaedic, Applied Research Award

The FY21 PRORP ARA seeks applied research applications focused on advancing optimal treatment and restoration of function for individuals with musculoskeletal injuries sustained during combat, combat-related activities, and non-battle injuries that impact unit readiness and the ability to return to duty/work. Applicants are encouraged to address how the proposed research will support patient care closer to the point of injury and/or allow patients to more quickly return to duty/work. It is expected that any research findings would also provide benefit to the general population. To meet the intent of the award mechanism, applications must specifically address an FY21 PRORP ARA Focus Area, listed in Section II.A.1, above.

The FY21 PRORP ARA is focused on applied research, defined as work that refines concepts and ideas into potential solutions with a view toward evaluating technical feasibility of promising new knowledge products, pharmacologic agents, behavioral and rehabilitation interventions, diagnostic and therapeutic techniques, clinical guidance, and/or emerging approaches and technologies.

Research Scope: Research proposed under the FY21 PRORP ARA may include small- to large-scale projects. Upon successful completion, the proposed research is expected to yield knowledge products, approaches, or technologies that have the potential to advance toward clinical translation. Strong transition plans are expected.

Inclusion of preliminary and/or published data relevant to the proposed research is required. Investigators must demonstrate logical reasoning for the proposed work. To be competitive, the application must include a sound scientific rationale and a well-formulated, testable hypothesis established through a critical review and analysis of the literature.

Studies allowed under the FY21 PRORP ARA may include, but are not limited to:

• Refinement of concepts and ideas into potential solutions, or research tools, with a view toward evaluating technical feasibility of emerging approaches, technologies, and promising new knowledge products.

• Evaluation, maturation, and/or down-selection of potential product candidates (drugs, biologic constructs, or devices/systems) in vitro and/or in vivo.

• Preparation activities needed to support a future clinical trial or regulatory submission.

Awards may not be used to support fundamental basic research. Basic research is defined as research directed toward greater knowledge or understanding of the fundamental aspects of phenomena and of observable facts without specific applications toward process or products in mind.

The types of awards made under the program announcement will be assistance agreements. An assistance agreement is appropriate when the federal government transfers a “thing of value” to a “state, local government,” or “other recipient” to carry out a public purpose of support or stimulation authorized by a law of the United States instead of acquiring property or service for the direct benefit and use of the U.S. government. An assistance agreement can take the form of a grant or cooperative agreement. The level of involvement on the part of the Department of Defense (DOD) during project performance is the key factor in determining whether to award a grant or cooperative agreement. If “no substantial involvement” on the part of the funding agency is anticipated, a grant award will be made (31 USC 6304). Conversely, if substantial involvement on the part of the funding agency is anticipated, a cooperative agreement will be made (31 USC 6305), and the award will identify the specific substantial involvement. Substantial involvement may include, but is not limited to, collaboration, participation, or intervention in the research to be performed under the award. The award type, along with the start date, will be determined during the negotiation process.

The anticipated total costs budgeted for the entire period of performance for an FY21 PRORP ARA will not exceed $725,000. Refer to Section II.D.5, Funding Restrictions, for detailed funding information.

Awards will be made no later than September 30, 2022. For additional information refer to Section II.F.1, Federal Award Notices.

The CDMRP expects to allot approximately $2.90M to fund approximately four Applied Research Award applications. Funding of applications received is contingent upon the availability of federal funds for this program as well as the number of applications received, the quality and merit of the applications as evaluated by scientific and programmatic review, and the requirements of the government. Funds to be obligated on any award resulting from this funding opportunity will be available for use for a limited time period based on the fiscal year of the funds. It is anticipated that awards made from this FY21 funding opportunity will be funded with FY21 funds, which will expire for use on September 30, 2027.