Opportunity Information: Apply for RFA HL 23 012
Catalyze: Product Definition for Small Molecules and Biologics - Preliminary Product/Lead Series Identification (R33 - Clinical Trial Not Allowed) is a National Institutes of Health (NIH) funding opportunity (RFA-HL-23-012) designed to help research teams bridge the gap between basic discovery and a viable therapeutic development program. The central purpose is to provide early translational support to identify and define a credible lead compound or lead series (for either small molecules or biologics) that could eventually become a therapeutic agent for conditions within the National Heart, Lung, and Blood Institute (NHLBI) mission areas, including heart, lung, blood, and sleep diseases and disorders. In practical terms, the FOA is aimed at taking promising early findings and pushing them far enough along that they become development-ready, either by meeting the entry requirements for the NHLBI Catalyze Preclinical program or by becoming attractive to other development partners in the federal or private sector who can carry the work forward into preclinical optimization and, later, clinical development.
This opportunity uses the R33 grant mechanism and explicitly does not allow clinical trials, signaling that the work should remain in the non-clinical translational space. The emphasis is on product definition and preliminary lead identification rather than human testing. Applicants are expected to focus on the key steps needed to converge on a lead series: establishing a compelling rationale for the therapeutic approach, demonstrating tractable and reproducible activity, and generating the kinds of data that reduce early technical risk. While the notice text provided does not list specific experimental requirements, the overall framing makes clear that NHLBI is looking for projects that can move beyond exploratory biology and toward a more development-minded package, such as evidence that a candidate modality can be advanced, iterated, and positioned for formal preclinical optimization.
As part of the NHLBI Catalyze suite of innovation grants, this FOA functions as an earlier rung in a staged translational pipeline. The intent is not only to fund science, but to help teams reach a decision point where the project can either (1) transition into more advanced NHLBI-supported preclinical efforts or (2) be sufficiently de-risked to secure independent support from outside partners. This makes it particularly relevant for teams that have a strong starting concept but still need resources and structure to define a true therapeutic lead, clarify the proposed product profile, and generate the early development evidence that sophisticated funders and translational programs typically expect.
The opportunity is listed as discretionary and uses a grant funding instrument. It is associated with CFDA numbers 93.233 and 93.837 through 93.840. The award ceiling is $350,000, based on the source data provided. The original closing date is December 20, 2024, and the FOA record creation date is January 24, 2022. The expected number of awards is not specified in the provided excerpt.
Eligibility is broad and includes many common applicant categories across government, academia, nonprofit, and industry. Eligible applicants include state, county, city/township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; Native American tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; small businesses; and other applicant types. The FOA also calls out additional eligible applicant groups such as 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, regional organizations, eligible agencies of the federal government, Indian/Native American tribal governments other than federally recognized, and U.S. territories or possessions.
On the foreign eligibility side, the FOA draws a clear line: non-domestic (non-U.S.) entities (foreign organizations and foreign institutions) are not eligible to apply as applicant organizations. At the same time, it allows non-domestic components of U.S. organizations to participate, and it allows foreign components as defined in the NIH Grants Policy Statement. That structure is common in NIH funding where the prime applicant must be U.S.-based, but parts of the work may be performed through allowable foreign collaborations when well-justified.
Overall, this FOA is best understood as an early translational push for therapeutic concepts that are still in the stage of selecting and justifying a lead or lead series, rather than optimizing a mature candidate or running human studies. It is meant for projects that can articulate a clear path to a defined therapeutic product concept in NHLBI-relevant diseases, generate development-relevant evidence around that concept, and then hand off into a preclinical optimization pathway, either through NHLBI Catalyze programs or external partners.Apply for RFA HL 23 012
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Catalyze: Product Definition for Small Molecules and Biologics - Preliminary Product/Lead Series Identification (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, 93.840.
- This funding opportunity was created on 2022-01-24.
- Applicants must submit their applications by 2024-12-20. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $350,000.00 in funding.
- 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)
What is this funding opportunity?
This opportunity is the NIH/NHLBI funding announcement titled "Catalyze: Product Definition for Small Molecules and Biologics - Preliminary Product/Lead Series Identification (R33 - Clinical Trial Not Allowed)" (RFA-HL-23-012). It supports early translational work to move promising discoveries toward a viable therapeutic development program by identifying and defining a credible lead compound or lead series.
Which NIH institute is sponsoring this program?
The opportunity is within the National Institutes of Health (NIH) and is aligned with the National Heart, Lung, and Blood Institute (NHLBI) mission areas.
What is the main purpose of this FOA?
The central purpose is to bridge the gap between basic discovery and a development-ready therapeutic program by supporting the identification and definition of a lead compound or lead series (small molecule or biologic) that could eventually become a therapeutic agent for diseases and disorders within NHLBI mission areas.
What types of therapeutic modalities are in scope?
The FOA explicitly supports both small molecules and biologics, as long as the project is focused on preliminary product definition and lead (or lead series) identification.
What disease areas does the FOA target?
The program targets conditions within NHLBI mission areas, including heart, lung, blood, and sleep diseases and disorders.
What stage of research is this FOA intended to support?
This FOA is intended for early translational research. It is aimed at taking promising early findings and pushing them far enough to become development-ready, particularly by converging on a credible lead compound or lead series and generating development-relevant evidence that reduces early technical risk.
What does "product definition" mean in the context of this FOA?
Based on the provided description, "product definition" refers to work that moves beyond exploratory biology toward a development-minded package. This includes clarifying the therapeutic rationale, demonstrating tractable and reproducible activity, and producing data that supports the feasibility of advancing, iterating, and positioning a candidate modality for preclinical optimization and later development.
What is meant by "preliminary lead series identification"?
It refers to the process of identifying and defining a credible lead compound or a set of related candidate molecules (a lead series) that can serve as the foundation for further preclinical optimization or partnering. The emphasis is on reaching a credible lead decision point rather than completing full optimization.
What is the funding mechanism for this opportunity?
This opportunity uses the NIH R33 grant mechanism.
Are clinical trials allowed under this FOA?
No. The FOA explicitly states "Clinical Trial Not Allowed," which means projects should remain in the non-clinical translational space and should not involve human testing.
If clinical trials are not allowed, what kind of work is expected?
The FOA emphasizes non-clinical translational work aimed at converging on a lead series. The description highlights expectations such as establishing a compelling rationale for the therapeutic approach, demonstrating tractable and reproducible activity, and generating data that reduces early technical risk and supports development readiness.
Is this FOA intended to fund late-stage preclinical optimization?
No. The opportunity is framed as an earlier step focused on lead/lead series identification and product definition, rather than optimization of a mature candidate.
How does this FOA fit into the NHLBI Catalyze program?
This FOA is described as an earlier rung in a staged translational pipeline within the NHLBI Catalyze suite of innovation grants. The goal is to help teams reach a decision point where the project can transition into more advanced preclinical efforts (such as the NHLBI Catalyze Preclinical program) or attract other federal or private development partners.
What outcomes is NHLBI looking for at the end of an award?
Based on the provided text, NHLBI is looking for projects that reach a credible decision point by defining a therapeutic product concept and identifying a lead or lead series with development-relevant evidence. The intent is for successful projects to be positioned to enter NHLBI Catalyze Preclinical efforts or become attractive to external partners for preclinical optimization and later clinical development.
What is the award ceiling for this opportunity?
The award ceiling is $350,000, based on the provided source data.
How is the opportunity classified in terms of funding instrument and category?
It uses a grant funding instrument and is listed as discretionary.
What CFDA numbers are associated with this opportunity?
The opportunity is associated with CFDA numbers 93.233 and 93.837 through 93.840.
What is the application deadline?
The original closing date provided is December 20, 2024.
When was the FOA record created?
The FOA record creation date is January 24, 2022.
How many awards will be made?
The expected number of awards is not specified in the provided excerpt.
Who is eligible to apply?
Eligibility is broad and includes many applicant types across government, academia, nonprofit, and industry. 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
- Private institutions of higher education
- Federally recognized Native American tribal governments
- Native American tribal organizations that are not federally recognized
- Public housing authorities / Indian housing authorities
- Nonprofits with 501(c)(3) status (other than institutions of higher education)
- Nonprofits without 501(c)(3) status (other than institutions of higher education)
- For-profit organizations other than small businesses
- Small businesses
- Other applicant types
Are certain institution types explicitly called out as eligible?
Yes. The FOA also calls out additional eligible applicant groups, 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
- Regional organizations
- Eligible agencies of the federal government
- Indian/Native American tribal governments other than federally recognized
- U.S. territories or possessions
Can foreign (non-U.S.) organizations apply as the main applicant?
No. Non-domestic (non-U.S.) entities, including foreign organizations and foreign institutions, are not eligible to apply as applicant organizations.
Are any foreign components allowed if the prime applicant is U.S.-based?
Yes. The FOA allows non-domestic components of U.S. organizations to participate, and it allows foreign components as defined in the NIH Grants Policy Statement. This indicates the prime applicant must be U.S.-based, but certain foreign collaborations/components may be permissible when appropriately structured.
Is this opportunity focused more on basic discovery or translational readiness?
It is focused on translational readiness. The description emphasizes moving beyond exploratory biology toward a development-minded package that supports lead/lead series definition and de-risking for downstream preclinical optimization and partnering.
What is the key value proposition for applicants?
The FOA is positioned to provide early translational support, resources, and structure to help teams define a true therapeutic lead, clarify a proposed product profile, and generate early development evidence that can enable progression into NHLBI Catalyze preclinical programs or attract external development partners.
What is the FOA identifier for this opportunity?
The FOA is identified as RFA-HL-23-012.
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