Funder: [National Institutes of Health - https://www.nih.gov]
Due Dates: November 21, 2024 (final) | Rolling prior dates through 2024
Funding Amounts: Up to $250,000 direct costs/year for R61 and R33 phases; total project period up to 3 years; cost matching required for R33 phase (0.25:1 non-Federal match)
Summary: Supports early-stage development and testing of device prototypes, diagnostic assays, and research tools for heart, lung, blood, and sleep (HLBS) disorders.
Key Information: Phased R61/R33 award; clinical trials not allowed; transition to R33 contingent on milestones, cost match, and accelerator partner; strong emphasis on project management and regulatory/IP planning.
Description
This funding opportunity from the National Heart, Lung, and Blood Institute (NHLBI) under the NIH Catalyze program provides early-stage translational support for the development and testing of device prototypes, diagnostic disease target identification and assay development, and research tool development specifically aimed at heart, lung, blood, and sleep (HLBS) diseases and disorders.
The program is structured as a phased R61/R33 award:
- R61 Phase: Focuses on initial prototype design and testing, disease target identification, assay development, and pilot testing of research tools.
- R33 Phase: Supports further development, optimization, user feedback incorporation, large-scale testing, and data integration.
The goal is to advance projects to a stage where they can enter NHLBI's Catalyze Preclinical program or attract independent development support for preclinical product optimization and characterization.
Projects must demonstrate novelty, a strong biological rationale, and relevance to NHLBI mission-relevant therapies. Clinical trials and therapeutic agent development are not supported under this FOA but are covered by companion FOAs.
Special requirements include:
- Project Management: Each project must identify a team member responsible for project management, supported by the Catalyze Coordinating Center.
- Milestones: Applicants must propose clear, measurable milestones for both R61 and R33 phases. Transition to R33 depends on achieving R61 milestones.
- Cost Matching: A minimum 0.25:1 non-Federal cash match is expected for the R33 phase.
- Accelerator Partner: Required for R33 phase to provide expertise in product development, commercialization, regulatory strategy, and mentoring.
Intellectual property and regulatory strategies must be addressed in the application and will be evaluated for transition to the R33 phase.
Due Dates
- Final application due date: November 21, 2024, 5:00 PM local time
- Earlier due dates were available in prior years; check NIH Guide for current opportunities.
- Letter of Intent: 30 days prior to application due date (optional but encouraged)
Funding Amount
- Direct costs up to $250,000 per year for each phase (R61 and R33)
- Total project period up to 3 years (up to 2 years for R61 and up to 2 years for R33; phases cannot overlap in the same fiscal year)
- Cost matching required for R33 phase: minimum 0.25:1 non-Federal cash match of Federal direct costs
- NHLBI intends to commit approximately $6.3 million per year to fund up to 13 new awards annually across this and companion FOAs
Eligibility
- Eligible Applicants:
- Public and private institutions of higher education (including HBCUs, Hispanic-serving institutions, etc.)
- Nonprofits with or without 501(c)(3) status (excluding institutions of higher education)
- For-profit organizations including small businesses
- State, county, city, township, and special district governments
- Federally recognized and other Native American tribal governments and organizations
- Independent school districts, public housing authorities, faith-based and community-based organizations, regional organizations
- Foreign Institutions: Not eligible to apply; however, foreign components of U.S. organizations are allowed.
- Clinical Trials: Not allowed under this FOA.
- Cost Sharing: Required for R33 phase as described above.
- Multiple Applications: Allowed if scientifically distinct; duplicate or highly overlapping applications will not be accepted.
Application Process
- Applications must be submitted electronically via Grants.gov and tracked in eRA Commons.
- Use SF424 (R&R) application forms, specifically Forms Version H.
- Include a detailed IP and Regulatory Strategies attachment describing intellectual property status and regulatory plans.
- Propose clear, measurable milestones and a timeline for both R61 and R33 phases.
- Include a description of plans for project management.
- Provide a plan for identifying and engaging an Accelerator Partner for the R33 phase.
- Include a Data Management and Sharing Plan as per NIH policy.
- Follow all NIH application instructions and page limits.
- Budget must reflect actual needs; include cost matching documentation for R33 phase prior to transition.
- Applicants are encouraged to contact NHLBI scientific staff prior to submission.
Additional Information
- This FOA is part of a suite of Catalyze innovation grants, with companion FOAs supporting therapeutic development and more advanced product development.
- The NHLBI Catalyze Coordinating Center provides program administration, milestone-driven project management support, and outreach.
- Applications will be reviewed for scientific and technical merit, with emphasis on significance, innovation, approach, investigator expertise, environment, and project management.
- Milestones and progress will be monitored quarterly; continuation to R33 phase depends on milestone achievement, cost match, and accelerator partner.
- Cost matching cannot be from other federal funds or program income.
- The NHLBI will assist awardees with regulatory, reimbursement, business, legal, and partner engagement expertise as needed.
- Clinical trials and clinical research are excluded from this FOA.
- The FOA expires November 22, 2024, and has been reissued as RFA-HL-26-019.
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