Opportunity Information: Apply for RFA HL 26 018
The NIH National Heart, Lung, and Blood Institute (NHLBI) is offering a discretionary grant opportunity under the NHLBI Catalyze Program called "Catalyze: Product Definition for Small Molecules, Biologics, and Combination Products - Preliminary Product/Lead Series Identification and Combination Product Prototype (R33 - Clinical Trial Not Allowed)" (Funding Opportunity Number RFA-HL-26-018). The program is designed to help move promising basic science discoveries toward real-world diagnostic and therapeutic products by giving teams the structured early translational support they need to turn an idea or early finding into a more clearly defined, development-ready candidate. A second core aim is workforce development: training and shaping translational researchers who understand not just biology and medicine, but also the practical steps of product development and entrepreneurship needed to bring innovations forward.
This particular "Product Definition" initiative focuses on early-stage activities for therapeutics and combination products aimed at heart, lung, blood, and sleep (HLBS) diseases and disorders. In practical terms, it is meant to fund and guide the work that happens before full preclinical development: identifying a viable therapeutic candidate or lead series (for example, selecting and refining small molecules or biologics with the right basic profile), characterizing those candidates in ways that reduce uncertainty, and for combination products, building an initial prototype. The broader NHLBI Catalyze ecosystem is set up like a pipeline, and this opportunity is positioned as a step that helps projects mature enough to meet entry criteria for the NHLBI Catalyze Preclinical Program. The announcement also notes that there is a companion initiative that supports device and diagnostic development, indicating that NHLBI is providing parallel tracks depending on whether a project is a therapeutic/combination product or a device/diagnostic.
The funding mechanism is an R33, and the notice clearly states "Clinical Trial Not Allowed." That means proposed work must stay on the preclinical and product-definition side of the line and should not involve testing the intervention in humans or conducting clinical trials. Applicants should expect to frame their milestones around candidate/lead identification, early characterization, and prototype development activities rather than clinical evaluation.
Eligibility is broad across many organization types. Eligible applicants include state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; Native American tribal governments (federally recognized); tribal organizations (other than federally recognized tribal governments); public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (excluding institutions of higher education in those nonprofit categories); for-profit organizations other than small businesses; and small businesses, among others. The opportunity explicitly calls out additional eligible applicant categories often emphasized by NIH for broad participation, including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal government agencies, regional organizations, and U.S. territories or possessions.
The opportunity includes important restrictions and clarifications on foreign involvement. Non-domestic (non-U.S.) entities (foreign organizations) are not eligible to apply as the applicant organization. However, non-domestic components of U.S. organizations are eligible to apply, and foreign components are allowed as defined in the NIH Grants Policy Statement. In other words, the applicant institution must be U.S.-based, but certain project elements may involve foreign components if they meet NIH policy requirements.
Administratively, the sponsoring agency is the National Institutes of Health, with activity categories in health and CFDA numbers listed as 93.233, 93.837, 93.838, and 93.839. The opportunity was created on 2024-11-22, and the original closing date listed is 2027-12-23, indicating a multi-year window during which applications may be accepted according to the schedule and cycles described in the full funding announcement. The notice does not provide an award ceiling or an expected number of awards in the provided text, so applicants would need to consult the full RFA for budget limits, project period details, review criteria, required milestones, and any program-provided services or support elements that may be part of the Catalyze model.Apply for RFA HL 26 018
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Catalyze: Product Definition for Small Molecules, Biologics, and Combination Products - Preliminary Product/Lead Series Identification and Combination Product Prototype (R33 - Clinical Trial Not Allowed)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.233, 93.837, 93.838, 93.839.
- This funding opportunity was created on 2024-11-22.
- Applicants must submit their applications by 2027-12-23.
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.
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Frequently Asked Questions (FAQs)
1) What is the name of this funding opportunity?
The opportunity is titled "Catalyze: Product Definition for Small Molecules, Biologics, and Combination Products - Preliminary Product/Lead Series Identification and Combination Product Prototype (R33 - Clinical Trial Not Allowed)."
2) What is the Funding Opportunity Number (FON)?
The Funding Opportunity Number is RFA-HL-26-018.
3) Which NIH Institute is offering this opportunity?
This opportunity is offered by the NIH National Heart, Lung, and Blood Institute (NHLBI).
4) What program is this opportunity part of?
It is part of the NHLBI Catalyze Program, which is positioned as a pipeline to help projects progress from early discoveries toward development-ready diagnostic and therapeutic products.
5) What is the primary purpose of this grant?
The purpose is to support early translational work that helps move promising basic science discoveries toward real-world therapeutic and combination product candidates by providing structured support to define the product and reduce uncertainty before full preclinical development.
6) What kinds of projects does this "Product Definition" initiative focus on?
It focuses on early-stage activities for therapeutics and combination products, specifically small molecules, biologics, and combination products targeting heart, lung, blood, and sleep (HLBS) diseases and disorders.
7) What specific development stage is targeted by this opportunity?
This initiative targets the stage before full preclinical development, emphasizing preliminary product/lead series identification, early characterization work to reduce uncertainty, and (for combination products) building an initial prototype.
8) How does this opportunity fit within the broader NHLBI Catalyze ecosystem?
It is described as a step in a larger pipeline, intended to help projects mature enough to meet entry criteria for the NHLBI Catalyze Preclinical Program.
9) Is there a related or companion initiative for other types of technologies?
Yes. The announcement notes there is a companion initiative that supports device and diagnostic development, indicating parallel tracks depending on whether a project is a therapeutic/combination product or a device/diagnostic.
10) What is the funding mechanism/activity code?
The mechanism is an R33.
11) Are clinical trials allowed under this opportunity?
No. The opportunity clearly states "Clinical Trial Not Allowed," meaning proposed work should not involve testing the intervention in humans or conducting clinical trials.
12) What types of milestones should applicants plan for, based on the description?
Applicants should expect to frame milestones around candidate or lead series identification, early characterization activities, and (for combination products) prototype development rather than any clinical evaluation activities.
13) What therapeutic areas or disease domains are in scope?
The opportunity targets heart, lung, blood, and sleep (HLBS) diseases and disorders.
14) Who is eligible to apply?
Eligibility is broad and includes many organization types, such as:
- State, county, and local governments
- Special district governments
- Independent school districts
- Public and state-controlled institutions of higher education
- Private institutions of higher education
- Native American tribal governments (federally recognized)
- Tribal organizations (other than federally recognized tribal governments)
- Public housing authorities / Indian housing authorities
- Nonprofits with and without 501(c)(3) status (excluding institutions of higher education in those nonprofit categories)
- For-profit organizations other than small businesses
- Small businesses
15) Are institutions and organizations serving specific communities explicitly highlighted as eligible?
Yes. The opportunity explicitly calls out additional eligible categories often emphasized by NIH for broad participation, including:
- Alaska Native and Native Hawaiian Serving Institutions
- Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)
- Hispanic-serving Institutions
- Historically Black Colleges and Universities (HBCUs)
- Tribally Controlled Colleges and Universities (TCCUs)
- Faith-based or community-based organizations
- Eligible federal government agencies
- Regional organizations
- U.S. territories or possessions
16) Can a foreign (non-U.S.) organization apply as the main applicant?
No. Non-domestic (non-U.S.) entities (foreign organizations) are not eligible to apply as the applicant organization.
17) Are any foreign components allowed on projects led by U.S. applicant organizations?
Yes. Non-domestic components of U.S. organizations are eligible to apply, and foreign components are allowed as defined in the NIH Grants Policy Statement. The applicant institution must be U.S.-based, but certain project elements may involve foreign components if they meet NIH policy requirements.
18) Who is the sponsoring agency?
The sponsoring agency is the National Institutes of Health (NIH), and the offering Institute is NHLBI.
19) What CFDA numbers are associated with this opportunity?
The CFDA numbers listed are 93.233, 93.837, 93.838, and 93.839.
20) When was this opportunity created?
The opportunity was created on 2024-11-22.
21) What is the closing date listed in the provided information?
The original closing date listed is 2027-12-23, suggesting a multi-year window during which applications may be accepted according to the schedule and cycles described in the full funding announcement.
22) Does the provided information state the award ceiling or the expected number of awards?
No. The provided text does not include an award ceiling or an expected number of awards.
23) Where should applicants look for budget limits, project period details, and review criteria?
Applicants would need to consult the full Request for Applications (RFA) for budget limits, project period details, review criteria, required milestones, and details on any program-provided services or support elements that may be part of the Catalyze model.
24) What should applicants keep in mind about the type of work that is appropriate for this R33?
Based on the description, the work should remain on the preclinical and product-definition side, concentrating on identifying and refining a viable candidate or lead series, characterizing candidates to reduce uncertainty, and developing an initial prototype for combination products, without crossing into human testing.
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