Catalyze: Product Definition Medical Device Prototype Optimization (R33 - Clinical Trial Not Allowed)
Open Posted
- Opportunity number
- RFA-HL-26-020
- Agency
-
National Institutes of Health
Department of Health and Human Services
- Applications due
- Award size
- Not on record
Opportunity facts
- Assistance listings
- Funding instrument
- Grant
- Category
-
- Health
- Eligible applicants
-
- County Governments
- Higher Education Inst. (Public)
- Small Businesses
- State Governments
- City/Township Governments
- Higher Education Inst. (Private)
- Tribal Governments (Federally Recognized)
- Tribal Organizations (Not Federally Recognized)
- Independent School Districts
- 501(c)(3) Nonprofits
- Special District Governments
- For Profit Organizations
- Public or Indian Housing Auth.
- Non-501(c)(3) Nonprofits
- Other
- Points of contact
-
- NIH OER Webmaster grantsinfo@nih.gov
- Full announcement
Opportunity details come from Grants.gov. Updated .
About this opportunity
The National Institutes of Health is soliciting applications for the NHLBI Catalyze Product Definition Medical Device Prototype Optimization grant (R33 - Clinical Trial Not Allowed) with an application due date of December 23, 2027. This initiative supports early-stage translational research for prototype testing and design modification, assay development for diagnostic disease targets, and research tool development focused on heart, lung, and blood (HLBS) diseases and disorders.
Eligible applicants include county, city, township, and state governments; small businesses; nonprofits (501(c)(3) and non-501(c)(3)); higher education institutions (public and private); tribal governments and tribal organizations; for-profit organizations; independent school districts; public or Indian housing authorities; and special district governments. The program also welcomes applications from Alaska Native and Native Hawaiian Serving Institutions, HBCUs, Hispanic-serving institutions, AANAPISIs, TCCUs, faith-based and community-based organizations, U.S. territories, and regional organizations. Non-domestic (non-U.S.) entities are not eligible as primary applicants, though non-domestic components of U.S. organizations and foreign components as defined in the NIH Grants Policy Statement are allowed.
The program aims to transition basic science discoveries into viable diagnostic and therapeutic candidates cleared for human testing and to develop translational researchers with expertise in product development and entrepreneurship. Successful applicants are expected to advance their products to in vivo testing (optimization, safety, efficacy) with support from NIH and other federal or private sources. The initiative is part of a broader NHLBI Catalyze suite that includes companion therapeutics development and preclinical program pathways.
The funding operates under CFDA numbers 93.838 (Lung Diseases Research), 93.837 (Cardiovascular Diseases Research), 93.839 (Blood Diseases and Resources Research), and 93.233 (National Center on Sleep Disorders Research). Applications are evaluated by initial peer review through an appropriate study section, followed by secondary review by the National Heart, Lung, and Blood Advisory Council. Evaluation emphasizes scientific merit, technical adequacy of design, investigator competency, adequacy of facilities and resources, budget necessity, and relevance to program objectives.
Synopsis
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 prototype testing/design modification, assay development for diagnostic disease targets, and development of research tools for use in the treatment of HLBS diseases and disorders. 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.
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.
Files
| File | Type | Posted |
|---|---|---|
| RFA-HL-26-020-Full-Announcement.html | HTML file | |
| PKG00288957.pdf |
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