RFA-HL-26-019: Catalyze Product Definition - Medical Device Prototype Design/Testing and Disease Target Identification and Assay Development (R61/R33; Clinical Trial Not Allowed)

RFA-HL-26-019: Catalyze Product Definition - Medical Device Prototype Design/Testing and Disease Target Identification and Assay Development (R61/R33; Clinical Trial Not Allowed)

Executive summary

RFA-HL-26-019 is a National Institutes of Health (NIH) Notice of Funding Opportunity from the National Heart, Lung, and Blood Institute (NHLBI). It is part of the NHLBI Catalyze program and funds early-stage product-definition work for devices, diagnostics, and research tools relevant to heart, lung, blood, and sleep (HLBS) diseases and disorders. The award uses a phased R61/R33 structure: the R61 phase establishes feasibility and early evidence, while the R33 phase supports continued development after the R61 milestones have been met.

The next listed due date for a new application is October 21, 2026, at 5:00 PM local time of the applicant organization. The notice also lists later new-application dates on February 11, June 17, and October 21, 2027. This is therefore an active recurring NOFO, not a closed historical listing. The page should be revisited before each submission because the notice says that the application schedule and submission requirements must be read together with the current NIH Application Guide and later NIH notices.

The program is not a general research award and is not a clinical-trial mechanism. It is intended for a defined product or tool whose development can be organized around measurable technical, biological, usability, regulatory, and product-development milestones. Applicants should be able to explain what the R61 work will establish, what evidence will justify the R33 phase, and how the resulting product could move toward preclinical development or other independent support.

Program purpose and project fit

The official notice describes three broad areas of work. A project may develop and test a medical-device prototype, identify a diagnostic disease target and develop associated assays, or develop a research tool for an HLBS application. The common thread is product definition: the proposed work should turn a scientifically grounded idea into a better specified, tested, and development-ready product or tool.

For a device, R61 work may include testing key components, using computational modeling to inform design, producing a first prototype or benchtop unit, conducting in-vitro or acute in-vivo testing, testing in a small-animal model, or carrying out limited biocompatibility, hemocompatibility, or histopathology work. R33 work may then include system integration, packaging and engineering optimization, design for manufacturing, comparison with a gold standard or competing device, verification and validation testing against appropriate standards, larger-animal or chronic in-vivo testing, and preparation for an FDA pre-submission meeting.

For a diagnostic, the R61 phase is aimed at identifying a disease target and generating the experimental design. Examples in the notice include testing with limited human samples, analyzing spiked samples or plasma, building a working prototype, scaling synthesis of an imaging agent, or adding an assay to an existing sensing platform. R33 work can include validation in a larger panel of human samples or clinical datasets, improvement of sensitivity, precision, accuracy, repeatability, and stability, comparison with a gold standard or competing device, FDA pre-submission preparation, evaluation of interfering analytes, and assessment of multiplex or miniaturized assay designs.

Research-tool projects have their own examples, including algorithms for HLBS disease detection, smartphone interfaces with limited user testing, pilot studies that establish feasibility for larger testing, focus groups for initial usability, and tools that integrate electronic-health-record data. The notice also gives later-phase examples such as larger population testing, wireless data integration, expansion to mobile platforms, and multi-site studies. Because the NOFO is marked “Clinical Trial Not Allowed,” applicants must determine carefully whether their proposed human research is an NIH-defined clinical trial. A project that proposes a clinical trial is nonresponsive even if the tool itself is relevant to HLBS research.

Award structure and funding

The R61 and R33 phases are linked, rather than two unrelated awards. Applicants submit milestones for both phases, and the R33 component is contingent on acceptable progress during R61. The notice requires two separate groups of clear, quantifiable milestones with timelines, completed sequentially within a combined project period of no more than three years. No phase may exceed two years, and the R61 and R33 phases cannot be awarded in the same fiscal year.

Application budgets may not exceed $300,000 in direct costs per year during R61 and may not exceed $300,000 in direct costs per year during R33. The total project budget, including any non-Federal matching contribution, should reflect the actual needs of the proposed work. NHLBI expects a minimum 0.25:1 non-Federal cash match of the Federal direct costs requested for the R33 phase. Proof of the match is not required with the initial application, but matching funds must be documented and reported as required, and federal funds may not be used as the match.

NHLBI states that it intends to commit up to $4,466,000 in total costs in each of fiscal years 2026, 2027, and 2028. The notice says those totals and up to eight new awards per year apply to this NOFO together with three companion Catalyze funding opportunities. They are program-level planning amounts, not a guaranteed award amount for each applicant or a promise that this one NOFO will make eight awards.

At least one Accelerator Partner is required for the R33 portion. An Accelerator Partner is a commercialization or product-development expert who can help the research team assess medical and commercial potential, connect with development partners, and address areas such as product development, business strategy, market analysis, regulatory submissions, intellectual property, and reimbursement. Evidence of an Accelerator Partner is not required at initial submission, but it is required when NHLBI evaluates transition from R61 to R33. Transition also depends on acceptable milestone progress and evidence of the required third-party, non-Federal cash match.

Eligibility

The notice permits applications from a broad set of U.S. applicant organizations. Eligible categories include public or private institutions of higher education; nonprofits with or without 501(c)(3) status; small businesses and other for-profit organizations; state, county, city, township, and special-district governments; eligible federal agencies; U.S. territories or possessions; tribal organizations; faith-based or community-based organizations; regional organizations; independent school districts; and public or Indian housing authorities.

Foreign organizations themselves are not eligible to apply. The notice does allow non-domestic components of U.S. organizations and foreign components as defined by NIH policy. That distinction should be checked with the applicant’s sponsored-research or grants office before the proposal is assembled.

Registration is an operational eligibility requirement. The applicant organization must maintain the registrations described in the NIH Application Guide and complete them before submission. The notice warns that registration may take six weeks or more, so an organization that is new to NIH systems should start well before the October 21, 2026 deadline. The allowed application types are New and Resubmission.

Application contents and submission route

The application package must be accessed through NIH ASSIST, an institutional system-to-system solution, or Grants.gov Workspace. An institutional system-to-system submission is tracked through Grants.gov and eRA Commons; applicants should confirm availability with their institutional officials. The NIH Application Guide supplies the general Research instructions, page limits, and form requirements, while this NOFO supplies additional Catalyze-specific instructions.

The Specific Aims section must contain separate headers for “R61 Phase Specific Aims” and “R33 Phase Specific Aims.” Each phase should state the objectives and activities that advance the proposed product. The Research Strategy must describe both phases and explain the biological rationale, the relationship between the product and the disease area, the unmet need, relevant product-development history, design novelty, and current project status. The strategy must also explain how R33 data will support later development.

The application must include an attachment named exactly IP and Regulatory Strategies.pdf. It is required, and an application without it is considered incomplete and will not be peer-reviewed. The attachment should describe known intellectual-property constraints, prior filings or publications, third-party rights, and plans for working with technology-transfer officials. It should also describe the regulatory path and the data needed for a future FDA pre-submission meeting, 510(k) filing, or Investigational Device Exemption filing when relevant. If the project is too early for a mature strategy, the application should say so and describe the current stage and possible future strategies.

Applicants must define specific, measurable, achievable, relevant, and time-bound milestones for both phases. A list of activities is not enough. The R61 milestones should show what feasibility, prototype, assay, or tool evidence will be produced and how it supports the R33 decision. The R33 milestones should show how the product will be improved, tested, compared, or prepared for the next development step. The timeline must be the last element of the Research Strategy and must show the sequence from R61 to R33.

The proposal should identify a team member responsible for project management, budget for appropriate project-management support, and include support for the PD/PI to attend an NHLBI-held 1.5-day innovation meeting or workshop once each budget year in the Washington, DC metropolitan area. Applicants conducting research that generates scientific data must address the NIH Data Management and Sharing Plan, and applications involving human subjects must use the appropriate human-subjects forms and study records.

Current schedule and planning notes

The official schedule includes the following new-application dates:

All applications are due by 5:00 PM local time of the applicant organization. The notice encourages early submission so that errors found during the submission process can be corrected before the due date. Its expiration date is December 24, 2027. The schedule is not a reason to wait: SAM, eRA Commons, Grants.gov, institutional approvals, letters for match support, and the required IP and regulatory attachment can all take time.

A practical preparation sequence

Start by matching the concept to the notice’s scope. Identify the HLBS disease or disorder, the unmet need, the product or tool, and the evidence that makes the approach plausible. Remove clinical-trial aims and therapeutic-agent development aims that belong in another Catalyze notice. If the proposal is for a device or diagnostic, decide what prototype or assay evidence can realistically be generated in R61 and what later work belongs in R33.

Next, build the milestone table before writing the narrative. Each milestone should have a measurable output, a target time, a responsible person, and a decision rule. Include technical risks and a fallback path. Draft the R61-to-R33 transition logic at the same time: the reviewers should be able to see why successful R61 work would justify the second phase and what evidence would indicate that the project should not continue.

Then assemble the development support plan. Identify potential Accelerator Partners early, map the regulatory and IP questions, and document any third-party rights or technology-transfer issues. Plan the non-Federal cash match for R33 without counting federal funds, program income, patient incentives, or other excluded sources. Budget for project management and the NHLBI innovation meeting or workshop requirement.

Finally, have the sponsored-research office validate the registrations, application type, forms, page limits, attachment filename, human-subjects classification, data-management plan, and submission route. Submit through ASSIST, the institutional system-to-system route, or Grants.gov Workspace early enough to resolve validation errors. The official NIH notice remains the controlling source for any change before submission.

Official source

The current notice is published by NIH and NHLBI at the RFA-HL-26-019 official funding opportunity page. The page lists the October 21, 2026 next new-application date, the later 2027 dates, the budget limits, the eligibility categories, the R61/R33 requirements, and the required submission materials.