The National Heart, Lung, and Blood Institute (NHLBI) is offering the Catalyze Product Definition grant to accelerate basic science discoveries into viable diagnostic and therapeutic candidates for heart, lung, blood, and sleep (HLBS) diseases. This phased R61/R33 initiative provides early-stage translational support. The R61 phase focuses on identifying and testing initial medical device prototypes, defining disease targets, and piloting research tools. The R33 phase supports continued prototype development, diagnostic product generation, and research tool improvement, preparing potential products for subsequent in vivo testing. This grant also aims to develop translational researchers proficient in product development and entrepreneurship.
Opportunity ID: 357339
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-HL-26-019 |
| Funding Opportunity Title: | Catalyze Product Definition Medical Device prototype design/testing and disease target identification and assay development (R61/R33 – Clinical Trial Not Allowed) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.233 — National Center on Sleep Disorders Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Nov 22, 2024 |
| Last Updated Date: | Nov 22, 2024 |
| Original Closing Date for Applications: | Dec 23, 2027 |
| Current Closing Date for Applications: | Dec 23, 2027 |
| Archive Date: | Jan 28, 2028 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Native American tribal governments (Federally recognized) Small businesses Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments Others (see text field entitled “Additional Information on Eligibility” for clarification) County governments City or township governments State governments Independent school districts For profit organizations other than small businesses Private institutions of higher education Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) Public and State controlled institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education |
| Additional Information on Eligibility: | Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | The goal of the NHLBI Catalyze Program is to provide a comprehensive suite of support and services to facilitate the transition of basic science discoveries into viable diagnostic and therapeutic candidates that have been cleared for human testing, and to develop translational researchers fluent in product development and entrepreneurship. 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. This initiative has a companion initiative that supports development of therapeutics and combination products and is also part of a suite of innovation grants to advance projects to the point where they can meet the entry criteria for the NHLBI Catalyze Preclinical Program. |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/rfa-files/RFA-HL-26-019.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH Grants Information
grantsinfo@nih.gov Email:grantsinfo@nih.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
Folder 357339 Full Announcement-RFA-HL-26-019 -> RFA-HL-26-019-Full-Announcement.pdf
Packages
| Agency Contact Information: | NIH Grants Information grantsinfo@nih.gov Email: grantsinfo@nih.gov |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| FORMS-I | Use for due dates on or after January 25, 2025 | PKG00288955 | Jan 11, 2025 | Dec 23, 2027 | View |
Package 1
Mandatory forms
357339 RR_SF424_5_0-5.0.pdf
357339 PHS398_CoverPageSupplement_5_0-5.0.pdf
357339 RR_OtherProjectInfo_1_4-1.4.pdf
357339 PerformanceSite_4_0-4.0.pdf
357339 RR_KeyPersonExpanded_4_0-4.0.pdf
357339 RR_Budget10_3_0-3.0.pdf
357339 PHS398_ResearchPlan_5_0-5.0.pdf
357339 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
357339 RR_SubawardBudget10_30_3_0-3.0.pdf
357339 PHS_AssignmentRequestForm_4_0-4.0.pdf
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