Opportunity Information: Apply for RFA DA 22 021

This opportunity, titled "Leveraging Artificial Intelligence (AI) tools for Substance Use Disorders (SUD) drug discovery and development (R41/R42 - Clinical Trial Not Allowed)," is a National Institutes of Health (NIH) funding announcement (RFA-DA-22-021) that supports small business-led research and development focused on using AI to accelerate or improve the drug discovery and drug development pipeline for substance use disorders. The emphasis is on developing AI-enabled technologies, methods, and platforms that can help identify, design, prioritize, and advance potential therapeutics for SUDs. A key boundary in the scope is that alcohol use disorder is excluded, meaning applicants should target other SUD areas rather than therapies specifically for alcohol-related conditions.

The mechanism is the NIH Small Business Innovation Research (SBIR) phased award structure using R41/R42. In practical terms, this generally means a Phase I (R41) period aimed at establishing feasibility and demonstrating proof-of-concept, followed by a Phase II (R42) period aimed at expanding, validating, and advancing the technology toward a more mature, product-ready stage. The announcement is explicitly "Clinical Trial Not Allowed," which signals that proposed work must not include clinical trials. Projects should remain in the preclinical, computational, and technology-development space, such as algorithm development, model training and validation, in silico screening, target identification, lead optimization, predictive toxicology, or other non-clinical steps that move drug candidates or drug-development decision-making forward without testing interventions in human subjects as clinical trials.

Eligible applicants are limited to small business concerns, aligning with the SBIR purpose of translating innovations into commercializable products and services. The listing also clarifies foreign eligibility restrictions: non-U.S. (foreign) institutions cannot apply as applicants, and non-U.S. components of U.S. organizations are not eligible to apply. However, foreign components as defined by the NIH Grants Policy Statement may be allowed in some circumstances, which typically means a U.S. small business could potentially include certain foreign collaborations or activities if they are well-justified, meet NIH policy requirements, and are formally treated as a foreign component rather than a foreign applicant organization.

From an administrative standpoint, the opportunity is categorized as a discretionary grant within the NIH health and education funding activity area and is associated with CFDA number 93.279. The funding announcement was created on April 8, 2021, with an original closing date of August 10, 2021. The source information provided does not specify an award ceiling or the expected number of awards, so applicants would normally look to the full FOA text and NIH SBIR budget guidance for typical phase limits, allowable costs, and any institute-specific caps or expectations.

Overall, the intent is to encourage small businesses to build and demonstrate AI-driven drug discovery and development capabilities that can meaningfully reduce timelines, improve candidate selection, increase predictive accuracy for efficacy or safety, or otherwise improve decision-making in the SUD therapeutic development process (excluding alcohol use disorder), while keeping the proposed research firmly on the non-clinical-trial side of the translational spectrum.

  • The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Leveraging Artificial Intelligence (AI) tools for Substance Use Disorders (SUD) drug discovery and development (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 2021-04-08.
  • Applicants must submit their applications by 2021-08-10. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • Eligible applicants include: Small businesses.
Apply for RFA DA 22 021

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