Catalyze: Enabling Technologies and Transformative Platforms for HLBS Research (R33 - Clinical Trials Not Allowed) | RFA HL 26 016

FAQs: Catalyze: Enabling Technologies and Transformative Platforms for HLBS Research (R33 - Clinical Trials Not Allowed)

What is this funding opportunity?

This is an NIH National Heart, Lung, and Blood Institute (NHLBI) funding opportunity under the NHLBI Catalyze Program titled "Catalyze: Enabling Technologies and Transformative Platforms for HLBS Research (R33 - Clinical Trials Not Allowed)." It is designed to advance promising early-stage scientific advances toward practical, real-world health impact by supporting validation-focused development of enabling technologies and multi-use platforms relevant to heart, lung, blood, and sleep (HLBS) research.

What is the main goal of the NHLBI Catalyze Program behind this opportunity?

The broader Catalyze Program aims to help investigators move basic research discoveries toward viable diagnostic or therapeutic candidates that can eventually be cleared for human testing, while also strengthening a translational workforce with experience in product development, regulatory expectations, and entrepreneurship. The emphasis is on building things that can realistically be advanced and adopted, not only on generating new knowledge.

What types of projects are being prioritized?

This initiative prioritizes enabling technologies and transformative, multi-use platforms rather than one-off, single-disease tools. Competitive projects are expected to propose platforms or technologies that can be validated and then reused across many projects, settings, or disease applications, with a credible path to accelerating HLBS research and downstream clinical and public health benefits.

What does "transformative, multi-use platform" mean in this context?

Based on the opportunity description, a transformative, multi-use platform is something that can be applied broadly rather than being limited to a single narrow use case. It should offer leverage for the broader HLBS community by changing timelines, reducing barriers, opening up new capabilities, or meaningfully speeding up or reshaping major parts of the translational pipeline.

Which parts of the translational pipeline are considered relevant targets for these platforms?

The opportunity identifies multiple translational areas where a platform could have impact, including early detection and screening, model development (including improved experimental or preclinical models), clinical diagnosis, treatment approaches, disease control strategies, behavior-related interventions, prevention, and epidemiology.

Does the opportunity require that a platform be limited to HLBS diseases only?

No. A platform may have broader applicability beyond HLBS, but the application must clearly justify how the platform will improve the outlook for diseases and disorders within NHLBI's mission space (heart, lung, blood, and sleep) and how the validation plan will de-risk the technology for adoption in that context.

What does the R33 mechanism imply for the kind of work that should be proposed?

The description signals an emphasis on disciplined, milestone-oriented development and validation. Applicants are expected to focus on robust technical development, performance evaluation, reproducibility, scalability, and evidence that the platform is ready to serve as a reliable foundation for later-stage translational or clinical efforts.

Are clinical trials allowed under this opportunity?

No. The opportunity explicitly states "Clinical Trials Not Allowed." The supported work is meant to remain on the enabling technology or platform validation side rather than moving into human efficacy testing.

If clinical trials are not allowed, what kind of evidence is NHLBI expecting?

The opportunity emphasizes rigorous validation to help technologies survive the transition from academic proof-of-concept to broadly usable solutions. This includes attention to performance evaluation, reproducibility, scalability, and other validation activities that de-risk the platform and demonstrate readiness for future adoption and later-stage work.

Is this opportunity focused on incremental improvements or bigger leaps?

The theme is leverage rather than incremental improvement. The work should aim to change timelines, reduce barriers, or create new capabilities that can accelerate HLBS research and its downstream benefits.

Who is eligible to apply?

Eligibility is broad and includes applicants from government, academia, nonprofit organizations, and industry. Eligible applicants include state, county, city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; and both nonprofit and for-profit organizations (including small businesses).

Are nonprofit organizations eligible even if they do not have 501(c)(3) status?

Yes. Nonprofits are eligible whether or not they have 501(c)(3) status, as long as they are not institutions of higher education (as stated in the eligibility description provided).

Are small businesses eligible to apply?

Yes. The eligibility description states that both for-profit organizations (other than small businesses) and small businesses can apply.

Are tribal entities eligible to apply?

Yes. Tribal participation is supported through federally recognized Native American tribal governments and Native American tribal organizations other than federally recognized tribal governments.

Are U.S. territories or possessions eligible to apply?

Yes. The eligibility description explicitly includes U.S. territories or possessions among eligible groups.

Are foreign (non-U.S.) organizations eligible to apply as the primary applicant?

No. Non-domestic (non-U.S.) entities (foreign organizations) are not eligible to apply as applicants.

Can a U.S.-based applicant include foreign components or non-domestic components?

Yes. The description states that non-domestic components of U.S. organizations are eligible, and foreign components (as NIH defines them in the Grants Policy Statement) are allowed. In practical terms, a U.S.-based applicant can include certain foreign collaborations or work elements when justified, but a foreign institution cannot be the primary applicant.

What additional types of institutions are explicitly highlighted as eligible?

The notice highlights a wide range of additional eligible groups, including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), faith-based or community-based organizations, Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), regional organizations, eligible federal agencies, and U.S. territories or possessions.

What is the Funding Opportunity Number (FOA number)?

The Funding Opportunity Number provided is RFA-HL-26-016.

What agency and institute are offering this opportunity?

This opportunity is offered by the National Institutes of Health (NIH), specifically through the National Heart, Lung, and Blood Institute (NHLBI).

What is the award ceiling listed for this opportunity?

The posted award ceiling is $350,000.

What is the original closing date?

The original closing date provided is 2027-12-23.

What type of grant is this described as?

It is described as a discretionary grant funding opportunity.

What category is the activity listed under?

The opportunity is listed with activity in the health category.

Which CFDA numbers are associated with this opportunity?

The CFDA numbers listed are 93.233, 93.837, 93.838, and 93.839.

How should applicants frame the HLBS relevance if the technology is broadly applicable?

Applicants should make a clear case that the platform will improve the outlook for diseases and disorders within NHLBI's mission space and present a rigorous validation plan that demonstrates the platform can be a reliable foundation for later-stage translational or clinical efforts in HLBS.

What signals does the opportunity give about what reviewers or program staff are likely to value?

The structure and messaging emphasize disciplined milestones and validation, practical translational utility, and the development of durable platforms that can be adopted by others to accelerate HLBS research and ultimately improve prevention, diagnosis, and treatment options.