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Catalyze: Product Definition for Small Molecules and Biologics - Target Identification and Validation, and Preliminary Product/Lead Series Identification (R61/R33 – Clinical Trials Not Allowed)
This Funding Opportunity Announcement (FOA) will provide the early stage translational support needed to identify and characterize potential therapeutic candidates (compound and lead series) to treat heart, lung, blood, and sleep diseases and disorders. This FOA is part of a suite of Catalyze innovation grants to advance projects to the point where they can meet the entry criteria for the NHLBI Catalyze Preclinical program or attract independent development support from other federal or private partners for preclinical optimization and development of therapeutic candidates.
This specific Catalyze Product Definition initiative will provide the early stage translational support needed for the activities required to develop potential therapeutic candidates to treat HLBS diseases and disorders. This FOA is intended to provide support for early stage projects through use of a bi-phasic approach. The R61 phase allows investigators to identify, validate and screen compounds of interest and the R33 phase supports identification of a lead series for pre-clinical testing and development. A companion FOA (RFA-HL-20-027) is available for more advanced projects that have already completed the activities supported by the R61 phase of this initiative, but need continued support to identify a lead series. Through Catalyze, the small molecule and biologics initiatives have companion initiatives that support development of devices and diagnostics (RFA-HL-20-024 and RFA-HL-20-028). See website for additional information.
- Letter of Intent: 30 days prior to the application due date
- Application Due Dates: November 8, 2019, March 9, 2020, March 9, 2021, July 9, 2021
- AIDS Application Due Dates: December 10, 2019, May 11, 2020, May 11, 2021, August 11, 2021
RFA-HL-20-023 Expiration Date: August 12, 2021
Application budgets must not exceed direct costs of $350,000 per year during the R61 phase and also must not exceed direct costs of $350,000 per year during the R33 phase.
The total budget (Federal award and non-Federal matching contributions) should reflect the actual needs of the overall proposed project. Annual project budgets should reflect the actual costs anticipated in each year.
Matching Fund Requirement: For the R33 portion of this award, the recipient is required to provide at least a 0.25:1 non-Federal match of the Federal direct costs requested.
The maximum project period of the combined R61 and R33 phases is three years, with up to 2 years for the R61 phase and up to 2 years for the R33 phase. The R61 and the R33 cannot be awarded in the same fiscal year. The scope of the proposed project should determine the requested project award period.