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W81XWH-21-TBDRP-CDA

The FY21 TBDRP CDA supports early-career investigators in their efforts to conduct impactful research with the mentorship of an experienced tick-borne diseases researcher (i.e., the mentor), thus providing an opportunity to obtain the funding, guidance, and experience necessary for productive, independent careers at the forefront of tick-borne diseases research. This award supports impactful research projects with an emphasis on discovery that may be translational in nature, but are not clinical trials. Under this award mechanism, the early-career investigator is considered the Principal Investigator (PI), and the application should focus on the PI’s research and career development. It should be clear that the proposed research is intellectually designed by the PI and not a product of the mentor. Preliminary data are not required; however, the research proposal should outline strong hypothesis-driven research supported by a robust scientific rationale. Through careful review of the literature, the PI and mentor should ensure that the proposed study is novel and non-duplicative in nature.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.The following are key aspects of the FY21 TBDRP Career Development Award:• Principal Investigator: The PI must be an early-career research scientist, physician scientist, or other qualified clinical scientist, within 10 years of completion of their terminal degree (excluding time spent in residency or on family medical leave). The PI’s record of accomplishments and the proposed research will be evaluated regarding their potential for contributing to the field of tick-borne diseases research. Because career development is the focus of this award, the PI’s institution should demonstrate a commitment to the PI through a minimum of 75% protected research time for all tick-borne diseases research projects by the PI, although more protected time is highly desirable.• Mentorship: The mentor must be an experienced tick-borne diseases researcher as demonstrated by a recent (last 5 years) history of funding and publications in tick-borne diseases research, and should ideally have experience mentoring other independent scientists.Collectively, the PI/mentorship team should have demonstrated experience in the field (pathogen/disease and associated methods) of the proposed studies. The mentor must hold a position at or above the level of Associate Professor (or equivalent). In addition, the mentor must demonstrate a commitment to developing the PI’s career in tick-borne diseases research. The mentor and PI may be at different organizations.• Career Development Plan: A career development plan is required and should be prepared by the PI with appropriate guidance from the mentor. The plan should outline how the PI will gain experience in tick-borne diseases research and engage with the tick-borne diseases scientific and advocacy communities (as applicable). A clearly articulated strategy for acquiring the necessary skills, competence, and expertise to establish a career at the forefront of tick-borne diseases research should be included, as well as a plan for how the mentor will contribute to the PI’s career development as a tick-borne disease researcher and to the success of the proposed research for the duration of the project.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 CDA award will not exceed $300,000. 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$1.44M to fund approximately 3 Career 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.
Categories: Science and Technology and other Research and Development.
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