Catalyze Product Definition Medical Device prototype design/testing and disease target identification and assay development (R61/R33 - Clinical Trial Not Allowed)
Open Posted
- Opportunity number
- RFA-HL-26-019
- 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
-
- Non-501(c)(3) Nonprofits
- Higher Education Inst. (Public)
- Tribal Organizations (Not Federally Recognized)
- Public or Indian Housing Auth.
- City/Township Governments
- County Governments
- Tribal Governments (Federally Recognized)
- For Profit Organizations
- 501(c)(3) Nonprofits
- Special District Governments
- Independent School Districts
- Small Businesses
- Other
- State Governments
- Higher Education Inst. (Private)
- 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 National Heart, Lung, and Blood Institute (NHLBI) seeks applicants for the Catalyze Product Definition initiative to support early-stage medical device prototype development, diagnostic assay creation, and research tool advancement for heart, lung, and blood disorders, with applications due December 23, 2027. This phased R61/R33 mechanism does not support clinical trials.
Eligible applicants include 501(c)(3) nonprofits, higher education institutions (public and private), tribal organizations (federally and non-federally recognized), state and local governments, small businesses, for-profit organizations, housing authorities, and special district governments. Non-domestic components of U.S. organizations are eligible; non-domestic entities themselves are not.
The R61 phase provides funding to identify and test initial prototype designs, identify a disease target and generate experimental design, and identify, test, and pilot research tools. The R33 phase supports continued prototype development and testing, design modification based on user feedback, diagnostic product generation, assay component exploration, load design characterization, and research tool improvement including large trial testing and data integration.
Applications are evaluated on scientific merit and general significance of proposed objectives; technical adequacy of experimental design and approach; competency of the investigator or group; adequacy of available and proposed facilities and resources; necessity of budget components relative to the proposed project; and relevance to announced program objectives.
Funding flows through four NIH programs: Lung Diseases Research (CFDA 93.838), Cardiovascular Diseases Research (CFDA 93.837), Blood Diseases and Resources Research (CFDA 93.839), and National Center on Sleep Disorders Research (CFDA 93.233). Following successful completion, products are expected to be positioned for in vivo testing with additional NIH or other federal and private support.
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 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.
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-26-019-Full-Announcement.html | HTML file | |
| PKG00288955.pdf |
On GovTribe
Work this opportunity
- Track it in your pipeline
- Find teaming partners
- Similar grant opportunities
- Ask GovTribe AI about this opportunity