Opportunity Information: Apply for RFA DA 22 023
The funding opportunity titled "Advancing Validated Drug Targets for Substance Use Disorders (R43/R44 - Clinical Trial Not Allowed)" is a National Institutes of Health (NIH) small business grant solicitation designed to move promising, well-supported drug targets for substance use disorders (SUDs) closer to the clinic. It uses the SBIR/STTR-style phased mechanism (R43/R44), which generally supports early-stage feasibility and development work in small business concerns, with the intent of advancing translational projects that have already cleared an important hurdle: the target is robustly validated. In other words, this program is not meant for speculative target discovery. It is meant for projects where the biological rationale is strong enough that the next logical step is to build the tools, compounds, and preclinical package needed to justify eventual human testing.
A central focus of this FOA is helping small businesses progress along the early drug development pipeline for SUD therapeutics. The announcement explicitly supports projects that enter at key preclinical stages: assay development (AD), lead identification (LI), lead optimization (LO), or preclinical development (PCD). That scope covers a broad span of work, from building and validating the screening assays that will be used to find or characterize compounds, through identifying initial chemical or biologic leads, improving those leads to achieve better potency, selectivity, and drug-like properties, and then completing the kinds of preclinical development studies that typically position a program for Investigational New Drug (IND)-enabling activities. The practical intent is to de-risk the program scientifically and technically so that, after this funding, the project is closer to meeting the evidence expectations for an IND submission pathway, even if the FOA itself is not paying for clinical testing.
The FOA is clear that clinical trials are not allowed under this solicitation. That means the supported research should remain on the preclinical side, such as in vitro studies, nonclinical in vivo pharmacology where appropriate, medicinal chemistry and optimization, ADME/PK profiling, early safety or tolerability assessments that do not constitute human trials, and other development tasks that build a credible dossier for later regulatory interactions. The end goal is not to run a clinical trial within the grant period, but to generate the validated assays, optimized leads, and preclinical evidence base that can justify and support the next translational leap.
Eligibility is intentionally narrow and oriented around U.S. innovation via small businesses. The eligible applicants are small business concerns, aligning with the R43/R44 mechanism and NIH's small business translational mission. The solicitation also specifies important restrictions related to foreign participation: non-domestic (non-U.S.) entities (foreign institutions) are not eligible to apply, and non-domestic components of U.S. organizations are not eligible to apply. At the same time, it notes that foreign components, as defined in the NIH Grants Policy Statement, may be allowed, which typically means limited, well-justified work performed outside the U.S. can sometimes be included as a component of a domestic application when it provides a unique resource, expertise, population, or capability that cannot be readily obtained in the U.S., and when it is consistent with NIH policy and program goals.
From the source details, this is a discretionary grant opportunity under the NIH, with the funding activity categorized under education and health, and associated with CFDA number 93.279. The opportunity number is RFA-DA-22-023, indicating it is an RFA issued within NIDA's domain (the DA prefix is commonly associated with the National Institute on Drug Abuse). The original closing date listed is February 18, 2022, and the record creation date is July 29, 2021. While the provided data do not specify an award ceiling or the expected number of awards, the purpose and structure suggest competitive, milestone-driven translational awards typical of NIH small business programs, where applicants are expected to present a coherent development plan, clear go/no-go criteria, and strong evidence that the target and approach are sufficiently validated to warrant product-focused investment.
Overall, the opportunity is best understood as a push to convert validated SUD biology into tangible therapeutic candidates by funding practical drug development steps inside small businesses. It aims to help applicants build credible assays, discover and refine leads, and assemble the preclinical development package that positions a project to complete IND-enabling work and ultimately enter clinical evaluation later, outside the scope of this specific "clinical trial not allowed" FOA.Apply for RFA DA 22 023
- The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Advancing Validated Drug Targets for Substance Use Disorders (R43/R44 - 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): 93.279.
- This funding opportunity was created on 2021-07-29.
- Applicants must submit their applications by 2022-02-18. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Small businesses.
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Frequently Asked Questions (FAQs)
What is the title of this funding opportunity?
The opportunity is titled "Advancing Validated Drug Targets for Substance Use Disorders (R43/R44 - Clinical Trial Not Allowed)."
Which federal agency is offering this grant?
This is a National Institutes of Health (NIH) funding opportunity. Based on the opportunity number (RFA-DA-22-023) and the DA prefix, it is associated with the National Institute on Drug Abuse (NIDA).
What is the main purpose of this FOA?
The purpose is to move promising, well-supported (robustly validated) drug targets for substance use disorders (SUDs) closer to the clinic by funding practical, preclinical drug development activities in small businesses.
What does "validated drug targets" mean in the context of this FOA?
It means the biological rationale for the target is already strong and well supported. This FOA is not intended for speculative target discovery; it is intended for projects where the target has cleared an important validation hurdle and the next step is to build tools, compounds, and a preclinical package to support later clinical translation.
Is this program meant for early target discovery research?
No. The FOA is positioned for projects that already have robust target validation and are ready to advance through preclinical development steps that reduce scientific and technical risk.
What grant mechanism does this opportunity use?
It uses the NIH small business phased mechanism R43/R44, consistent with SBIR/STTR-style feasibility and development support for small business concerns.
What types of projects or stages of drug development are supported?
The FOA explicitly supports entry at key preclinical stages, including assay development (AD), lead identification (LI), lead optimization (LO), and preclinical development (PCD).
What is included under assay development (AD) in this FOA?
Assay development includes building and validating screening assays used to find, characterize, or prioritize compounds or biologics against the validated SUD drug target.
What is included under lead identification (LI)?
Lead identification covers efforts to identify initial chemical or biologic leads, typically using validated assays and other preclinical methods to find promising starting points for development.
What is included under lead optimization (LO)?
Lead optimization includes improving leads to achieve better potency, selectivity, and drug-like properties, often through iterative design and testing (for example, medicinal chemistry and related profiling).
What is included under preclinical development (PCD)?
Preclinical development includes the kinds of nonclinical studies that position a program for later IND-enabling activities, such as generating a credible preclinical evidence base and development package.
Are clinical trials allowed under this FOA?
No. The FOA explicitly states that clinical trials are not allowed. Funded work must remain on the preclinical side.
If clinical trials are not allowed, what types of research activities are appropriate?
Appropriate activities include in vitro studies, nonclinical in vivo pharmacology where appropriate, medicinal chemistry and optimization, ADME/PK profiling, and early safety or tolerability assessments that do not constitute human trials, along with other preclinical development tasks that help support later regulatory steps.
What is the intended endpoint or outcome of this funding?
The intent is to de-risk a translational program and generate validated assays, optimized leads, and a credible preclinical evidence base that better positions the project for an IND submission pathway later (even though the FOA itself does not fund clinical testing).
Who is eligible to apply?
Eligible applicants are small business concerns, consistent with the NIH R43/R44 small business program structure.
Can a non-U.S. (foreign) organization apply as the main applicant?
No. Non-domestic (non-U.S.) entities (foreign institutions) are not eligible to apply.
Can a U.S. organization apply if the work will be performed by its non-U.S. component?
No. The FOA specifies that non-domestic components of U.S. organizations are not eligible to apply.
Are any foreign activities allowed at all?
Potentially yes. The FOA notes that foreign components (as defined in the NIH Grants Policy Statement) may be allowed, which typically refers to limited, well-justified work performed outside the U.S. when it provides unique resources, expertise, populations, or capabilities not readily available in the U.S., and when consistent with NIH policy and program goals.
What is the opportunity number for this FOA?
The opportunity number is RFA-DA-22-023.
What is the CFDA number associated with this opportunity?
The CFDA number listed is 93.279.
How is this grant categorized in the source details?
It is described as a discretionary grant opportunity under NIH, with the funding activity categorized under education and health.
When was this opportunity record created?
The record creation date listed is July 29, 2021.
What was the original closing date?
The original closing date listed is February 18, 2022.
Does the provided information specify the award ceiling or the expected number of awards?
No. The provided details do not specify an award ceiling or the expected number of awards.
What kind of application approach does this FOA imply?
Based on the described purpose and structure, it implies a competitive, milestone-driven translational approach typical of NIH small business programs, where applicants present a coherent development plan, clear go/no-go criteria, and strong evidence that the target and approach are sufficiently validated for product-focused investment.
What kinds of substance use disorder (SUD) therapeutic efforts is this FOA trying to accelerate?
It is trying to accelerate the conversion of validated SUD biology into tangible therapeutic candidates by supporting the practical steps needed to create robust assays, discover and refine leads, and assemble the preclinical development package needed for later regulatory and clinical progression.
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| Fentanyl and its Analogs: Effects and Consequences for Treatment of Addiction and Overdose (UG3/UH3 Clinical Trial Optional) Apply for RFA DA 22 022 Funding Number: RFA DA 22 022 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Maximizing Opportunities for Scientific and Academic Independent Careers (MOSAIC) Institutionally-Focused Research Education Award to Promote Diversity (UE5 - Clinical Trial Not Allowed) Apply for PAR 21 277 Funding Number: PAR 21 277 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
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| A Multilevel Approach to Connecting Underrepresented Populations to Clinical Trials (CUSP2CT U01 Clinical Trial Not Allowed) Apply for RFA CA 21 057 Funding Number: RFA CA 21 057 Agency: National Institutes of Health Category: Education, Health Funding Amount: $450,000 |
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