Catalyze Funding Opportunities
Currently, there are five funding opportunities: two that target therapeutics (dependent on early or late entry stage of development), two that target devices, diagnostics, and tools (dependent on early or late entry stage of development), and one that targets enabling technologies and transformative platforms. The five funding opportunities are summarized in the table below.
| FOA # and Title | Funding Mechanism | Funding Purpose |
|---|---|---|
|
Catalyze: Enabling Technologies and Transformative Platforms for HLBS Research (R33 - Clinical Trials Not Allowed) |
R33 (Direct to R33) R33 Exploratory/Developmental Grants Phase II |
This NOFO solicits R33 applications where major feasibility gaps for the enabling technology or transformative platform have already been overcome, as demonstrated with supportive preliminary data, but still requires further development and rigorous validation to encourage downstream demonstration, utilization and adoption. Well-suited applications must offer the potential to accelerate and/or transform the areas of early detection and screening, model development, clinical diagnosis, treatment, control, prevention or epidemiology, while addressing issues associated with HLBS-related diseases and disorders. Projects proposing application of existing technologies where the novelty resides in the biological or clinical target/question being pursued are not appropriate for this solicitation. Applications considered nonresponsive to the NOFO will not be reviewed. |
|
Catalyze: Product Definition for Small Molecules, Biologics and Combination Products - Target Identification and Validation, and Preliminary Product/Lead Series Identification (R61/R33 – Clinical Trials Not Allowed) |
R61/R33 Phase 1 Exploratory/Developmental Grant/ Exploratory/Developmental Grants Phase II |
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. |
|
Catalyze: Product Definition for Small Molecules, Biologics, and Combination Products - Preliminary Product/Lead Series Identification and Combination Product Prototype (R33 - Clinical Trial Not Allowed) |
R33 (Direct to R33) R33 Exploratory/Developmental Grants Phase II |
This Notice of Funding Opportunity (NOFO) will provide the early stage translational support needed to identify a lead compound series toward development of potential therapeutic agents to treat heart, lung, blood, and sleep (HLBS) diseases and disorders. |
|
Catalyze: Product Definition – Medical Device prototype design/testing and disease target identification and assay development (R61/R33 - Clinical Trial Not Allowed) |
R61/R33 Phase 1 Exploratory/Developmental Grant/ Exploratory/Developmental Grants Phase II |
This Notice of Funding Opportunity (NOFO) will provide the early stage translational support needed to develop and test device prototype designs, identify diagnostic disease targets and develop associated assays, and develop research tools for use in the treatment of heart, lung, blood and sleep (HLBS) diseases and disorders. |
|
Catalyze: Product Definition – Medical Device Prototype Optimization (R33 - Clinical Trial Not Allowed) |
R33 (Direct to R33) R33 Exploratory/Developmental Grants Phase II |
This Notice of Funding Opportunity (NOFO) will provide the early stage translational support needed for prototype testing/design modification, assay development for diagnostic disease targets, and development of research tools for use in the treatment of heart, lung, blood, and sleep (HLBS) diseases and disorders. |
Catalyze Key Dates to Remember
| Application Due Dates | Review and Award Cycles | ||||
|---|---|---|---|---|---|
| New | Renewal / Resubmission / Revision (as allowed) | AIDS | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
| February 11, 2025 | February 11, 2025 | April 21, 2025 | July 1, 2025 | October 1, 2025 | December 1, 2025 |
| June 18, 2025 | June 18, 2025 | August 21, 2025 | November 1, 2025 | January 1, 2026 | April 1, 2026 |
| October 21, 2025 | October 21, 2025 | December 22, 2025 | March 1, 2026 | May 1, 2026 | July 1, 2026 |
| February 11, 2026 | February 11, 2026 | April 21, 2026 | July 1, 2026 | October 1, 2026 | December 1, 2026 |
| June 18, 2026 | June 18, 2026 | August 21, 2026 | November 1, 2026 | January 1, 2027 | April 1, 2027 |
| October 21, 2026 | October 21, 2026 | December 23, 2026 | March 1, 2027 | May 1, 2027 | July 1, 2027 |
| February 11, 2027 | February 11, 2027 | April 23, 2027 | July 1, 2027 | October 1, 2027 | December 1, 2027 |
| June 17, 2027 | June 17, 2027 | August 23, 2027 | November 1, 2027 | January 1, 2028 | April 1, 2028 |
| October 21, 2027 | October 21, 2027 | December 23, 2027 | March 1, 2028 | May 1, 2028 | July 1, 2028 |
Phased Awards (R61/R33) and Direct to R33
Catalyze funding mechanism requirements (budget limits, cost sharing, Accelerator Partnerships, etc.) differ according to the type of technology under development, the stage of development, and the duration of the project. For therapeutic and device/diagnostic/tool development, both phased (R61/R33) and R33 awards are available. Researchers with projects that are earlier in development may apply for phased awards, while those with more advanced projects may apply directly for an R33 opportunity. In a phased award, transition from the R61 phase to the R33 phase is based on successful completion of the R61 phase and meeting additional R33 requirements.
This table summarizes the differences between the funding mechanisms:
| FOA # | RFA-HL-26-016 | RFA-HL-26-017 | RFA-HL-26-018 | RFA-HL-26-019 | RFA-HL-26-020 |
|---|---|---|---|---|---|
| Technology Type | Enabling Technologies & Transformative Platforms | Therapeutics | Therapeutics | Devices/Diagnostics/Tools | Devices/Diagnostics/Tools |
| FOA Name | Catalyze: Enabling Technologies and Transformative Platforms for HLBS Research | Catalyze: Product Definition for Small Molecules, Biologics and Combination Products - Target Identification and Validation, and Preliminary Product/Lead Series Identification | Catalyze: Product Definition for Small Molecules, Biologics, and Combination Products - Preliminary Product/Lead Series Identification and Combination Product Prototype | Catalyze: Product Definition – Medical Device prototype design/testing and disease target identification and assay development | Catalyze: Product Definition – Medical Device Prototype Optimization |
| (R33 - Clinical Trials Not Allowed) | (R61/R33 – Clinical Trials Not Allowed) | (R33 - Clinical Trial Not Allowed) | (R61/R33 - Clinical Trial Not Allowed) | (R33 - Clinical Trial Not Allowed) | |
| Budget amounts | Application budgets must not exceed $350,000 direct costs per year. | 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. | Application budgets must not exceed direct costs of $400,000 per year. 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. | Application budgets must not exceed direct costs of $300,000 per year during the R61 phase and also must not exceed direct costs of $300,000 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. | Application budgets must not exceed direct costs of $300,000 per year. 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 sharing expectations | No cost sharing required | 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. | The recipient is expected to provide at least a 0.25:1 non-Federal match of the Federal direct costs requested. | 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. | The recipient is expected to provide at least a 0.25:1 non-Federal match of the Federal direct costs requested. |
| Letter of support for cost sharing funds | No cost sharing required | Required to transition from R61 to R33 phase | Required at time of application | Required to transition from R61 to R33 | Required at time of application |
| Special Requirements | Requires a separate attachment that describes the milestones, timeline and project management plan. In addition, within the Research Section applicants are required to include a subsection to describe performance measures. | Requires a separate attachment that describes the milestones, timeline and project management plan. In addition, within the Research Section applicants are required to include a subsection to describe performance measures. | Requires a separate attachment that describes the milestones, timeline and project management plan. In addition, within the Research Section applicants are required to include a subsection to describe performance measures. |