This Notice of Funding Opportunity (NOFO) 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 (HLBS) diseases and disorders. This NOFO 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 NOFO will provide the early stage translational support needed for the activities required to develop potential therapeutic candidates and combination products to treat HLBS diseases and disorders. This NOFO 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 develop the individual components of a combination drug product and the R33 phase supports identification of a lead series for pre-clinical testing and development. A companion NOFO (RFA-HL-26-018) 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 or further test a combination product. A therapeutic candidate with two or more distinct, individual components should use RFA-HL-26-017 and its companion RFA-HL26-018. Individual components may be include a drug, a biologic, a combination product including a cell or genetic therapy component, or an eligible biologic regulated by the FDA's Center for Biologics Evaluation and Research (CBER), or Center for Drug Evaluation and Research (CDER). Through Catalyze, the small molecule and biologics initiatives have companion initiatives that support development of devices and diagnostics (RFA-HL-26-019 and RFA-HL-26-020) and an initiative that supports the development of enabling technologies and transformative platforms (RFA-HL-26-016). See website for additional information.
Deadlines:
- Letter of Intent: 30 days prior to the application due date
- Application Due Dates: Feb. 11, 2025; June 18, 2025; Oct 21, 2025; Feb 11, 2026; June 18, 2026; Oct 21, 2026; Feb 11, 2027; June 17, 2027; Oct 21, 2027
- AIDS Application Due Dates: April 21, 2025; Aug 21, 2025; Dec 22, 2025; April 21, 2026; Aug 21, 2026; Dec 23, 2026; April 23, 2027; August 23, 2027; Dec 23, 2027
RFA-HL-26-019 Expiration Date: December 24, 2027
Application budgets must not exceed direct costs of $400,000 per year during the R61 phase and also must not exceed direct costs of $400,000 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.
Cost Matching Funds: For the R33 portion of this award, the recipient is expected to provide at least a 0.25:1 non-Federal match of the Federal direct costs requested.