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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.
Funding Opportunity Number: RFA-HL-26-019. Assistance Listing: 93.233,93.837,93.838,93.839. Funding Instrument: G. Category: HL.
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Search similar grants →According to the current listing, eligibility includes: Eligible applicants: State governments; County governments; City or township governments; Special district governments; Independent school districts; Public and State controlled institutions of higher education; Native American tribal governments (Federally recognized); Public housing authorities / Indian housing authorities; Native American tribal organizations (other than Federally recognized); Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education; Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education; Private institutions of higher education; For-profit organizations other than small businesses; Small businesses; Others (see text field entitled Additional Information on Eligibility for clarification). 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. Confirm the full requirements in the official notice before applying.
Applications for Catalyze Product Definition Medical Device prototype design/testing and disease target identification and assay development (R61/R33 - Clinical Trial Not Allowed) are due December 23, 2027. Build your timeline backwards from this date to cover registrations, approvals, and final submission checks.
Yes — Catalyze Product Definition Medical Device prototype design/testing and disease target identification and assay development (R61/R33 - Clinical Trial Not Allowed) is offered by National Institutes of Health and this listing comes from Grants.gov, an official U.S. federal source. Federal applications generally require registrations (for example SAM.gov or an agency submission portal), so allow extra lead time.
This opportunity targets applicants in Alaska and Hawaii. Check the official notice for exact location requirements.
Start from the official opportunity page linked in this listing — it carries the sponsor's submission instructions.
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