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  1. Product Definition
  2. Funding Opportunities and Application Information

Funding Opportunities and Application Information

What's new?

Major changes to the Product Definition Notice of Funding Opportunities renewals (issued November 22, 2024)

  • Maximum Direct Cost increased for all NOFOs
  • All Combination products with a drug component should apply to the therapeutic NOFOs (HL-26-017 (R61/R33) or HL-26-018 (R33))
  • In addition to New and Resubmission applications, the R33 NOFOs for Therapeutics (HL-26-018) and Devices (HL-26-020) now accept Renewal applications of Catalyze R33 awards.

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

RFA-HL-26-016

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.

RFA-HL-26-017

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 (Phased Award)

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.

RFA-HL-26-018

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.

RFA-HL-26-019

Catalyze: Product Definition – Medical Device prototype design/testing and disease target identification and assay development (R61/R33 - Clinical Trial Not Allowed)

R61/R33 (Phased Award)

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.

RFA-HL-26-020

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 DatesReview and Award Cycles
NewRenewal / Resubmission / Revision
(as allowed)		AIDSScientific Merit ReviewAdvisory Council ReviewEarliest Start Date
February 11, 2025February 11, 2025April 21, 2025July 1, 2025October 1, 2025December 1, 2025
June 18, 2025June 18, 2025August 21, 2025November 1, 2025January 1, 2026April 1, 2026
October 21, 2025October 21, 2025December 22, 2025March 1, 2026May 1, 2026July 1, 2026
February 11, 2026February 11, 2026April 21, 2026July 1, 2026October 1, 2026December 1, 2026
June 18, 2026June 18, 2026August 21, 2026November 1, 2026January 1, 2027April 1, 2027
October 21, 2026October 21, 2026December 23, 2026March 1, 2027May 1, 2027July 1, 2027
February 11, 2027February 11, 2027April 23, 2027July 1, 2027October 1, 2027December 1, 2027
June 17, 2027June 17, 2027August 23, 2027November 1, 2027January 1, 2028April 1, 2028
October 21, 2027October 21, 2027December 23, 2027March 1, 2028May 1, 2028July 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.

Letter of Intent

  • Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information it contains allows Institutes and Center (IC) staff to estimate the potential review workload and plan the review.
  • Part 1. Overview Information provides the due date for the letter of intent. Prospective applicants should include the following information in the letter:
    • Descriptive title of proposed activity
    • Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
    • Names of other key personnel
    • Participating institution(s)
    • Number and title of this funding opportunity
  • The letter of intent should be sent to:

R61/R33 Transition for development of therapeutics (RFA-HL-26-017) and devices/diagnostics/tools (RFA-HL-26-019)

  • For phased awards, evidence of the cost match and identification of the Accelerator Partner is not required for the initial application.
  • 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 cost match by inclusion of a letter of support addressed to NIH.
    • Provide a letter of support as evidence that an Accelerator Partner has been identified.
  • Expectations for phased awards (RFA-HL-26-017 and RFA-HL-26-019)
    • Proof of matching funds is not required at the time of initial application and activation of the R61 phase of these awards.
    • As the R61 phase nears its end, evidence of non-Federal 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. NHLBI recommends a minimum of a 0.25:1 non-Federal cost match of the Federal direct costs.
    • 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 cost match is expected prior to release of R33 federal funds.
    • The Enabling Technologies and Transformative Platforms for HLBS research RFA (RFA-HL-26-016) does not have a cost sharing component.
  • Progress and achievement of these requirements will be evaluated by an NHLBI committee tasked with making advancement decisions.

Cost Matching Component

  • Expectations for the non-phased R33 awards for therapeutics (RFA-HL-26-018) and device / diagnostics/tools (RFA-HL-26-020)
    • The non-phased applications must include a letter of support from the non-Federal source(s) of cost matching. Applications that do not include this letter will be considered nonresponsive and will not be peer reviewed.
    • Evidence of the cost match equivalent to at least 25% of the direct federal costs of the award 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-26-016) does not have a cost sharing component.
  • Cost Matching Component Requirements
    • 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 cost matching requirements. 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 cost 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