Opportunity Information: Apply for RFA HL 20 023
Catalyze: Product Definition for Small Molecules and Biologics - Target Identification and Validation, and Preliminary Product/Lead Series Identification (R61/R33 Clinical Trials Not Allowed) is a National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI) funding opportunity designed to help research teams move promising basic discoveries toward real therapeutic development. The focus is on early translational work that turns an interesting biological idea into a clearer product concept by validating a drug target and identifying an initial therapeutic approach, whether that is a small-molecule program or a biologic (such as an antibody, peptide, protein, or other modality). The diseases and disorders of interest fall within NHLBI's mission areas, specifically heart, lung, blood, and sleep-related conditions.
This opportunity sits within NHLBI's broader "Catalyze" suite of innovation grants, which are meant to bridge the gap between academic discovery and later-stage development. The practical goal is to help projects mature to the point where they can either (1) meet the entry criteria for the NHLBI Catalyze Preclinical program, where more advanced preclinical optimization and development activities can occur, or (2) become attractive enough to secure independent development support from other federal programs or private-sector partners. In other words, the FOA is structured to help investigators de-risk a therapeutic concept by producing the kinds of data that funders and development partners typically require before investing in more expensive preclinical work.
The scientific scope emphasizes two major translational steps: target identification and validation, and preliminary product or lead series identification. Target identification and validation generally includes demonstrating that a specific biological target is meaningfully linked to disease biology and that manipulating it produces a desirable effect. Preliminary product or lead series identification generally includes finding an initial set of candidate therapeutic entities (for example, an early lead compound series for small molecules or initial biologic candidates) and beginning to characterize them enough to justify further optimization. The intent is not to complete full preclinical development, but to generate credible evidence that a tractable target exists and that a feasible therapeutic starting point has been identified.
The award mechanism is an R61/R33, which is a phased approach commonly used by NIH to support milestone-driven translational research. Typically, the earlier phase supports proof-of-concept and feasibility work, and the later phase supports expansion and refinement once predefined milestones are met. While specific milestone language is set by the application and negotiated at award, the underlying idea is that continued funding is tied to measurable progress rather than open-ended exploratory research. The FOA explicitly states that clinical trials are not allowed, reinforcing that supported activities must remain in the non-clinical translational space (for example, discovery, validation, and early candidate identification and characterization, rather than testing interventions in humans).
From an administrative standpoint, this is a discretionary federal grant funded by the U.S. Department of Health and Human Services through NIH/NHLBI. The opportunity number is RFA-HL-20-023, and it is categorized under health-related funding activities. It is associated with multiple CFDA (assistance listing) numbers, including 93.233 and several NHLBI-related listings (93.837 through 93.840), reflecting the institute's different program authorities.
Eligibility is intentionally broad and includes a wide range of potential applicants across academia, government, nonprofit, and industry. Eligible applicants include public and state-controlled institutions of higher education, private institutions of higher education, nonprofits with and without 501(c)(3) status (excluding higher education institutions in those categories), for-profit organizations (including those other than small businesses), small businesses, and various government entities (state, county, city/township, special districts, and independent school districts). The eligibility list also includes Native American tribal governments (federally recognized) and tribal organizations (other than federally recognized tribal governments), as well as public housing authorities and Indian housing authorities, with additional clarifications referenced in the full FOA text. This broad eligibility is consistent with the program's translational aim, since early therapeutic development often benefits from academic-industry collaboration or from applied R&D capacity housed outside traditional academic settings.
In terms of scale, the FOA listed an award ceiling of $350,000 and anticipated making around 13 awards. While the ceiling indicates the maximum award size under the announcement, actual budgets typically depend on the scope of work proposed and the program's expectations for milestone-driven deliverables. The opportunity was originally created on September 9, 2019, and the original closing date was August 11, 2021, indicating a defined application window for proposals under this specific announcement.
Overall, this grant opportunity is best understood as an early translational "product definition" on-ramp for therapeutic programs in NHLBI mission areas. It supports the work needed to transform an early scientific insight into a more development-ready package by establishing why a target matters, showing that it can be manipulated in a therapeutically meaningful way, and identifying initial candidate molecules or biologic leads that can serve as the starting point for preclinical optimization or external partnering.Apply for RFA HL 20 023
- The Department of Health and Human Services, National Institutes of Health in the health sector is offering a public funding opportunity titled "Catalyze: Product Definition for Small Molecules and Biologics - Target Identification and Validation, and Preliminary Product/Lead Series Identification (R61/R33 Clinical Trials 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 Sep 09, 2019.
- Applicants must submit their applications by Aug 11, 2021. (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.
- The number of recipients for this funding is limited to 13 candidate(s).
- 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 (see text field entitled Additional Information on Eligibility for clarification).
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Frequently Asked Questions (FAQs)
What is the purpose of this funding opportunity?
This NIH/NHLBI opportunity is designed to help research teams move promising basic discoveries toward therapeutic development by doing early translational work that clarifies and de-risks a potential product concept. The emphasis is on validating a drug target and identifying an initial therapeutic approach (small molecule or biologic) that can serve as a credible starting point for later preclinical development or partnering.
What is the official title of the opportunity?
Catalyze: Product Definition for Small Molecules and Biologics - Target Identification and Validation, and Preliminary Product/Lead Series Identification (R61/R33 Clinical Trials Not Allowed).
Which agency and institute are sponsoring this grant?
The sponsor is the National Institutes of Health (NIH), specifically the National Heart, Lung, and Blood Institute (NHLBI), within the U.S. Department of Health and Human Services (HHS).
What is the funding opportunity number?
The opportunity number is RFA-HL-20-023.
What scientific areas or diseases does this opportunity focus on?
The diseases and disorders of interest fall within NHLBI mission areas: heart, lung, blood, and sleep-related conditions.
What types of research activities are supported?
The scope emphasizes two early translational steps: (1) target identification and validation, and (2) preliminary product or lead series identification for either small molecules or biologics (such as antibodies, peptides, proteins, or other modalities). The goal is to generate evidence that a tractable target exists and that a feasible therapeutic starting point has been identified.
What does "target identification and validation" mean in the context of this FOA?
It generally means demonstrating that a specific biological target is meaningfully linked to disease biology and that manipulating the target produces a desirable effect. In other words, the project should build a credible case that the target matters and that intervening on it could be therapeutically useful.
What does "preliminary product/lead series identification" mean here?
It generally refers to finding an initial set of candidate therapeutic entities, such as an early lead compound series for small molecules or initial biologic candidates, and beginning to characterize them enough to justify further optimization and development in a later program stage.
Does this opportunity support small molecules, biologics, or both?
Both. The program supports early product definition work for small-molecule programs and for biologic modalities (including antibodies, peptides, proteins, and other biologic approaches).
Is the intent to complete full preclinical development?
No. The intent is not to complete full preclinical development. The focus is on generating credible validation and early lead identification data that make a project ready for more advanced preclinical optimization or attractive for external development support.
How does this FOA fit within NHLBI's broader programs?
This opportunity is part of NHLBI's broader "Catalyze" suite of innovation grants, which are intended to bridge the gap between academic discovery and later-stage development.
What are the expected next steps after completing this project?
The practical goal is to help projects mature so they can either (1) meet entry criteria for the NHLBI Catalyze Preclinical program (where more advanced preclinical optimization and development can occur), or (2) become attractive enough to secure independent development support from other federal programs or private-sector partners.
What funding mechanism is used for this opportunity?
The award mechanism is an R61/R33, a phased NIH approach that supports milestone-driven translational research.
What does the R61/R33 phased mechanism imply for applicants?
It implies a milestone-based structure: the earlier phase typically supports proof-of-concept and feasibility work, and the later phase supports expansion and refinement once predefined milestones are met. Continued funding is tied to measurable progress rather than open-ended exploratory research, with milestones proposed in the application and negotiated at award.
Are clinical trials allowed under this FOA?
No. The FOA explicitly states that clinical trials are not allowed. Supported activities must remain in the non-clinical translational space (such as discovery, validation, and early candidate identification and characterization), rather than testing interventions in humans.
Who is eligible to apply?
Eligibility is broad and includes: public and state-controlled institutions of higher education; private institutions of higher education; nonprofits with and without 501(c)(3) status (excluding higher education institutions in those nonprofit categories); for-profit organizations (including those other than small businesses); small businesses; and many government entities.
Which government entities are listed as eligible?
The eligibility list includes state governments; county governments; city or township governments; special district governments; independent school districts; and other entities referenced in the FOA.
Are tribal governments and tribal organizations eligible?
Yes. The eligibility list includes Native American tribal governments (federally recognized) and tribal organizations (other than federally recognized tribal governments).
Are public housing authorities eligible?
Yes. Public housing authorities and Indian housing authorities are included in the eligibility list, with additional clarifications referenced in the full FOA text.
Can industry apply, including companies that are not small businesses?
Yes. The eligibility list includes for-profit organizations, including those other than small businesses, as well as small businesses.
What is the maximum award amount mentioned in the FOA?
The FOA listed an award ceiling of $350,000.
How many awards were anticipated?
The FOA anticipated making around 13 awards.
Will every project receive the maximum budget?
Not necessarily. While the FOA lists a ceiling, actual budgets typically depend on the scope of work proposed and the program's expectations for milestone-driven deliverables.
When was this funding opportunity created and when did it close?
The opportunity was originally created on September 9, 2019. The original closing date was August 11, 2021, indicating a defined application window for proposals under this specific announcement.
What type of federal funding is this?
This is a discretionary federal grant funded by HHS through NIH/NHLBI, categorized under health-related funding activities.
Which CFDA (assistance listing) numbers are associated with this opportunity?
It is associated with multiple CFDA (assistance listing) numbers, including 93.233 and several NHLBI-related listings (93.837 through 93.840).
What is the overall "product definition" outcome this program is trying to achieve?
The program is intended to transform an early scientific insight into a more development-ready package by establishing why a target matters, showing that it can be manipulated in a therapeutically meaningful way, and identifying initial candidate small molecules or biologic leads that can serve as the starting point for preclinical optimization or external partnering.
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