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 |
|---|---|---|
|
Enabling Technologies and Transformative Platforms |
(Direct to R33) |
To develop enabling technologies and transformative platforms to catalyze next-generation predictive, diagnostic, and therapeutic products. applications must offer the potential for projects to accelerate progress and/or transform current protocol in the areas of early detection and screening, model development, clinical diagnosis, treatment, control, prevention, or epidemiology |
|
Product Definition - Small Molecule and Biologic Target Identification and Validation, Assay Development, and Screening |
phased award |
To identify, validate, and screen compounds of interest and to identify a lead compound series to move into preclinical testing for optimization, safety, and efficacy |
|
Product Definition - Small Molecule and Biologic Lead Series Preliminary Product/Lead Series Identification |
(Direct to R33) |
To develop and move a lead compound series forward to preclinical testing For projects that have already identified, validated and screened compounds of interest and are therefore far enough along in development to skip R61 stage |
|
Product Definition - Device Prototype Design/Testing and Diagnostic Disease Target Identification and Assay Development, Research Tool Development |
phased award |
For initial development of prototypes through testing, identifying diagnostic disease targets and developing associated assays, and developing research tools |
|
Product Definition - Device prototype testing and Diagnostic disease assay development, and Research Tool Development |
(Direct to R33) |
To develop and test existing device prototypes, explore assay components for diagnostics validation, and develop research tools For projects that have already identified and tested initial prototype designs, that have identified a disease target and generated experimental design, or that identified, tested and piloted research tools, and are therefore far enough along in development to skip R61 stage |
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 21, 2024 | February 21, 2024 | April 18, 2024 | July 1, 2024 | October 1, 2024 | December 1, 2024 |
| July 22, 2024 | July 22, 2024 | August 19, 2024 | November 1, 2024 | January 1, 2025 | April 1, 2025 |
| November 21, 2024 | November 21, 2024 | December 20, 2024 | March 1, 2025 | May 1, 2025 | July 1, 2025 |
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-23-010 | RFA-HL-23-011 | RFA-HL-23-012 | RFA-HL-23-013 | RFA-HL-23-014 |
|---|---|---|---|---|---|
| Technology Type | Enabling Technologies & Transformative Platforms | Therapeutics | Therapeutics | Devices/Diagnostics/Tools | Devices/Diagnostics/Tools |
| FOA Name | Enabling Technologies and Transformative Platforms for HLBS Research (R33 - Clinical Trials Not Allowed) | Product Definition for Small Molecules and Biologics - Target Identification and Validation, and Preliminary Product/Lead Series Identification (R61/R33 – Clinical Trials Not Allowed) | Product Definition for Small Molecules and Biologics - Preliminary Product/Lead Series Identification (R33 - Clinical Trial Not Allowed) | Product Definition – Device Prototype Design and Testing, Diagnostic Disease Target Identification and Assay Development, and Research Tool Development (R61/R33 | Product Definition – Device Prototype Testing and Design Modification, Diagnostic Disease Target Assay Development and Design Characterization, and Research Tool Testing and |
| Clinical Trial Not Allowed) | Validation (R33 - Clinical Trials Not Allowed) | ||||
| Budget amounts | Maximum direct costs of $300,000 per year | Maximum direct costs of $350,000 per year in either the R61 or R33 phase | Maximum direct costs of $350,000 per year | Maximum direct costs of $250,000 per year in either the R61 or R33 phase | Maximum direct costs of $250,000 per year. |
| Cost sharing expectations | No cost sharing required | For the R33 portion ONLY: minimum 0.25:1 non-federal cash match of the federal direct costs recommended | Minimum of 0.25:1 non-federal cash match of the federal direct costs recommended | For the R33 portion ONLY: minimum 0.25:1 non-federal cash match of the federal direct costs recommended | Minimum of 0.25:1 non-federal cash match of the federal direct costs recommended |
| 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 |
R61/R33 Transition for development of therapeutics (RFA-HL-23-011) and devices/diagnostics/tools (RFA-HL-23-013)
- To transition from the R61 to R33 phase, awardees must do the following:
- achieve acceptable progress toward milestones
- demonstrate the ability to secure third-party investment by providing evidence of non-federal cash match
- provide a letter of support as evidence that an Accelerator Partner has been identified.
- Progress and achievement of these requirements will be evaluated by an NHLBI committee tasked with making advancement decisions.
- For phased awards, evidence of having secured the cash match and the Accelerator Partner is not required at the time of application, but will be needed at the time of R61 milestone review to transition to an R33 award.
Cost Share
- Expectations for phased awards (RFA-HL-23-011 and RFA-HL-23-013)
- Proof of matching funds is not required at the time of application and onset of the R61 phase of these awards, but will be expected as part of the transition process to the R33 award. As the R61 phase nears its end, evidence of matching funds must be provided to NIH in the form of a letter of support prior to the meeting of the NHLBI committee that makes the advancement decisions. To be considered responsive to these FOAs, applicants are expected to include a description in the Budget Justification of how the matching funds will be used for the R33 phase of the award. Evidence of the cash match is expected prior to release of R33 federal funds.
- The Enabling Technologies and Transformative Platforms for HLBS research RFA (RFA-HL-23-010) does not have a cost sharing component.
- Expectations for the non-phased R33 awards for therapeutics (RFA-HL-23-012) and device/diagnostics/tools (RFA-HL-23-014)
- The non-phased applications must include a letter of support from the non-federal source(s) of cash matching. Applications that do not include this letter will be considered unresponsive and will not be peer reviewed. Evidence of the cash match is required prior to release of R33 federal funds. This requirement is not negotiable.
- The Enabling Technologies and Transformative Platforms for HLBS Research RFA (RFA-HL-23-010) does not have a cost sharing component.
- Cost share what does and does not count
- Sources of non-federal funding could include, but are not necessarily limited to, foundations, participating institutions, a state or local governmental body, angel investors, venture capital firms, individual benefactors, or any combination of the above.
- In-kind contributions are encouraged, but do NOT apply to the cash matching requirements and do not need to be reported to the NIH. Institutions must be able to document their actual contributions to the project and provide assurances that the organization(s) are committed to providing the funds and resources for their share of the project.
- It is acceptable for an Accelerator Partner to provide cash matching funds for the R33 stage, but it is not required.
- Federal funds may NOT be used as a source of cost sharing.
- Generally, cost share requirements may NOT be met from the following sources:
- Costs borne by another federal grant or sub award
- Costs or contributions toward cost sharing on another federal grant, a federal procurement, contract, or any other award of Federal funds
- Cost of services or property financed by income earned by contractors under a contract from the recipient (or sub recipient)
- Program income
- Patient incentives