DoD Tick-Borne Disease, Idea Development Award by CDMRP

The FY21 TBDRP IDA intends to support research that could lead to impactful discoveries or significant advancements that will accelerate progress toward improving Lyme disease and/or other tick-borne diseases research, patient care, and/or quality of life for military Service Members, Veterans, and their beneficiaries, as well as the American public. This research should be conceptually innovative, introducing a new concept or question, challenging existing paradigms, approaching issues from a new perspective, or exhibiting other uniquely creative qualities, and should not merely be an incremental advance upon published data. Applications must describe the short- and long-term impact of the proposed research, as well as the evidence-based burden of disease on public health. Applications should also include a well-formulated, testable hypothesis based on strong scientific rationale that is established through logical reasoning, critical review and analysis of the literature, and/or preliminary data (if available). This award mechanism promotes basic through translational research, including preclinical and clinical research, as well as correlative studies associated with an existing clinical trial to establish proof-of-principle for further development in future studies.

Research involving human subjects and human anatomical substances is permitted; however, clinical trials are not allowed under this program announcement. A clinical trial is defined as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.

To leverage existing resources and maximize statistical power, the use of validated specimens from Lyme and other tick-borne disease biorepositories and databases is encouraged, but not required. Investigators are strongly encouraged to incorporate the following components into their study design where appropriate: authentication of proposed cell lines; statistical rigor of in vitro cellular studies and preclinical animal experiments; and validation in well-pedigreed cohorts of uniformly documented patients. Studies utilizing data derived from large patient studies that include long-term health records, biospecimen repositories, and pre-existing research, and/or studies that apply state-of-the art genomic and/or proteomic analysis, bioinformatics, and/or mathematical models to such data are also encouraged. The criteria defining the inclusion/exclusion of curated biospecimens or data in biorepositories or databases must be described to demonstrate the validity of their use in the proposed studies.

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 direct costs budgeted for the entire period of performance for an FY21 TBDRP IDA Award will not exceed $600,000. 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 $4.8M to fund approximately 5 Idea Development 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.