Catalyze: Product Definition – Device Prototype Design and Testing, Diagnostic Disease Target Identification and Assay Development, and Research Tool Development (R61/R33 - Clinical Trial Not Allowed)

Funding Agency:
National Institutes of Health

This Catalyze Product Definition Funding Opportunity Announcement (FOA) 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. 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 product optimization and characterization.

This specific Catalyze Product Definition initiative will provide the early stage translational support needed for the activities required to develop and test device prototypes, identify diagnostic disease targets and develop associated assays, and develop research tools to treat HLBS diseases and disorders. This is a phased initiative for early stage projects. The R61 phase provides support to identify and test initial prototype designs, to identify a disease target and generate experimental design, and to identify, test and pilot research tools. The R33 phase provides support for continued prototype development and testing, in addition to modifying design features and user feedback, diagnostic product generation, exploration of assay components, and characterization of a load design, and research tool improvement, large trial testing and data integration. Following successful completion of the program, it is expected that the potential products will be poised to move forward for in vivo testing (optimization, safety, efficacy) with additional support from NIH and/or other federal and private programs. A companion FOA (RFA-HL-23-014) is available for more advanced projects that have already completed the activities supported by the R61 phase of this initiative, but need support for continued development of their product. For innovators developing small molecule and biologics, Catalyze has companion initiatives that support therapeutic development (RFA-HL-23-011 and RFA-HL-23-012) and an initiatve that supports the development of enabling technologies and transformative platforms for HLBS (RFA-HL-20-010). See website for additional information.


  • Letter of Intent: 30 days prior to the application due date
  • Application Due Dates: March 21, 2022; July 21, 2022; Nov 21, 2022; Feb 21, 2023; July 21, 2023; Nov 21, 2023; Feb 21, 2024; July 22, 2024; Nov 21, 2024
  • AIDS Application Due Dates: April 18, 2022; Aug 18, 2022; Dec 21, 2022; April 18, 2023; Aug 18, 2023; Dec 21, 2023; April 18, 2024; Aug 19, 2024; Dec 20, 2024

RFA-HL-23-013 Expiration Date: December 21, 2024

Agency Website

Amount Description

Application budgets must not exceed direct costs of $250,000 per year during the R61 phase and also must not exceed direct costs of $250,000 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.

Funding Type





Medical - Translational

External Deadline

February 21, 2024