Opportunity Information: Apply for RFA DA 22 018
The grant opportunity "Advancing Validated Drug Targets for Substance Use Disorders (R41/R42 - Clinical Trial Not Allowed)" is a National Institutes of Health (NIH) small business funding program aimed at pushing promising, well-supported drug targets for substance use disorders (SUDs) further down the development pipeline. It is issued as Funding Opportunity Number RFA-DA-22-018 and uses the SBIR mechanism (R41/R42), which is specifically designed to help small business concerns translate scientific and technical innovation into products that can ultimately benefit public health. The focus here is not on early, speculative target discovery, but on continuing projects where the biological target is already "robustly validated," meaning there is strong evidence linking the target to SUD biology and a reasonable basis for believing that modulating it could produce therapeutic benefit.
The core purpose of the announcement is to fund small businesses working on discrete stages of preclinical drug development, with the expectation that awardees will advance toward the kinds of studies needed to support an Investigational New Drug (IND) application. The FOA explicitly welcomes projects entering at several common drug development inflection points: assay development (AD), lead identification (LI), lead optimization (LO), or preclinical development (PCD). In practical terms, that means a company might propose to build or refine a screening assay suitable for finding active compounds, screen for initial hits and identify leads, improve those leads to achieve better potency/selectivity and drug-like properties, or complete more advanced preclinical packages such as pharmacokinetics, safety-related studies, formulation work, and other IND-enabling activities. The unifying theme across these entry points is progression: the work should materially de-risk the program and move it closer to being IND-ready.
This is a discretionary grant program in the NIH health and education activity space and is associated with CFDA number 93.279, which corresponds to NIH substance abuse and addiction research activities (historically tied to NIDA-supported programs). While the scientific topic is SUD therapeutics, the structure is clearly product-development oriented: the government is trying to accelerate the translation of validated targets into tangible candidate therapeutics by supporting the expensive, milestone-heavy work that often occurs between basic discoveries and a development candidate suitable for regulatory submission.
Eligibility is centered on U.S. small businesses, consistent with SBIR rules and NIH policy. The FOA states that non-domestic (non-U.S.) entities (foreign institutions) are not eligible to apply, and non-domestic components of U.S. organizations are also not eligible. At the same time, it leaves room for "foreign components" as defined in the NIH Grants Policy Statement to be allowed, which typically refers to limited, well-justified parts of the project being conducted outside the U.S. under specific conditions and approvals, rather than the applicant organization itself being foreign. This matters for applicants that may rely on specialized assays, chemistry, or animal model capabilities that exist abroad, but it does not change the basic rule that the applicant must be an eligible U.S. small business concern.
The "Clinical Trial Not Allowed" designation indicates that the work supported under this FOA must remain in the preclinical and translational development domain and cannot include clinical testing in human subjects as defined by NIH clinical trial policy. In other words, the intent is to fund the build-up of the evidence package needed to justify first-in-human studies, not to run those human studies under this specific award.
Key administrative details provided include an original closing date of February 18, 2022, and a creation date of July 29, 2021. The source listing does not specify an award ceiling or the number of expected awards, which often means applicants need to consult the full FOA text for budget limits, project period constraints, and any milestone or go/no-go requirements that NIH commonly applies to product development-focused SBIR/STTR announcements. Overall, the opportunity is best understood as NIH support for small companies that already have a strong SUD target rationale and are ready to do the rigorous development work needed to generate optimized leads and preclinical data packages that can realistically feed into IND-enabling development plans.Apply for RFA DA 22 018
- 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 (R41/R42 - 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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FAQs: Advancing Validated Drug Targets for Substance Use Disorders (R41/R42 - Clinical Trial Not Allowed)
What is the name of this grant opportunity?
The opportunity is titled "Advancing Validated Drug Targets for Substance Use Disorders (R41/R42 - Clinical Trial Not Allowed)".
Which agency is offering this funding?
This is a National Institutes of Health (NIH) funding opportunity in the health and education area, associated with NIH substance abuse and addiction research activities.
What is the Funding Opportunity Number (FOA number)?
The Funding Opportunity Number is RFA-DA-22-018.
What type of funding mechanism is used?
The FOA uses the SBIR mechanism under R41/R42, which is designed to help small business concerns translate scientific and technical innovation into products that can benefit public health.
What is the overall purpose of the program?
The purpose is to push promising, well-supported (robustly validated) drug targets for substance use disorders (SUDs) further down the development pipeline by funding specific stages of preclinical drug development expected to move a program toward the kinds of studies needed to support an Investigational New Drug (IND) application.
What kinds of projects are a good fit for this FOA?
This FOA is intended for product-development oriented projects that advance an already validated SUD therapeutic target through concrete preclinical development steps that de-risk the program and move it closer to IND-readiness.
Is this opportunity meant for early-stage target discovery?
No. The focus is not on early, speculative target discovery. It is meant for projects where the biological target is already robustly validated, with strong evidence linking the target to SUD biology and a reasonable basis for believing that modulating it could provide therapeutic benefit.
What does "robustly validated" mean in this context?
Based on the description provided, "robustly validated" means there is strong evidence connecting the target to substance use disorder biology and a reasonable basis to believe that modulating the target could produce therapeutic benefit.
What stages of drug development does the FOA support?
The FOA welcomes projects entering at several common preclinical drug development inflection points, including:
- Assay development (AD)
- Lead identification (LI)
- Lead optimization (LO)
- Preclinical development (PCD)
What is meant by assay development (AD) under this program?
Assay development work can include building or refining a screening assay that is suitable for finding active compounds against the validated target.
What is meant by lead identification (LI) under this program?
Lead identification can include screening for initial hits and identifying leads that act on the validated target.
What is meant by lead optimization (LO) under this program?
Lead optimization can include improving leads to achieve better potency, selectivity, and other drug-like properties.
What is meant by preclinical development (PCD) under this program?
Preclinical development can include more advanced packages such as pharmacokinetics, safety-related studies, formulation work, and other IND-enabling activities.
What is the unifying expectation across the supported entry points?
The unifying theme is progression: proposed work should materially de-risk the program and move it closer to being IND-ready.
Are clinical trials allowed under this FOA?
No. The FOA is designated "Clinical Trial Not Allowed", meaning the supported work must remain in the preclinical and translational development domain and cannot include clinical testing in human subjects as defined by NIH clinical trial policy.
If clinical trials are not allowed, what is the intent regarding human studies?
The intent is to fund the build-up of evidence needed to justify first-in-human studies later, not to run those human studies under this specific award.
Who is eligible to apply?
Eligibility is centered on U.S. small businesses, consistent with SBIR rules and NIH policy.
Are non-U.S. (foreign) institutions eligible to apply?
No. The FOA states that non-domestic (non-U.S.) entities (foreign institutions) are not eligible to apply.
Are non-domestic components of U.S. organizations eligible?
No. The FOA also states that non-domestic components of U.S. organizations are not eligible.
Can any part of the work be done outside the United States?
The description indicates the FOA leaves room for "foreign components" as defined in the NIH Grants Policy Statement to be allowed in limited cases. This generally refers to well-justified portions of the project being conducted outside the U.S. under specific conditions and approvals, while the applicant organization remains an eligible U.S. small business.
What is the CFDA number associated with this opportunity?
The opportunity is associated with CFDA 93.279, corresponding to NIH substance abuse and addiction research activities (historically tied to NIDA-supported programs).
What are the key dates mentioned?
The information provided lists a creation date of July 29, 2021 and an original closing date of February 18, 2022.
Does the listing specify an award ceiling or number of expected awards?
No. The source listing does not specify an award ceiling or the number of expected awards.
Where would an applicant typically find budget limits, project period constraints, or milestone requirements?
Because those details are not included in the listing provided, applicants would typically need to consult the full FOA text for any budget limits, project period constraints, and milestone or go/no-go requirements often used in product development-focused SBIR announcements.
What kind of applicant is this opportunity best suited for?
It is best suited for a small company that already has a strong SUD target rationale and is ready to do the rigorous, milestone-driven work needed to generate optimized leads and preclinical data packages that can feed into IND-enabling development plans.
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| Coordinating and Data Management Center for Acquired Resistance to Therapy Network (ARTNet; U24 Clinical Trial Not Allowed) Apply for RFA CA 21 053 Funding Number: RFA CA 21 053 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
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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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| National Cancer Institute Youth Enjoy Science Research Education Program (R25 Clinical Trial Not Allowed) Apply for RFA CA 21 020 Funding Number: RFA CA 21 020 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| 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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