Opportunity Information: Apply for RFA DA 24 038
Developing Regulated Therapeutic and Diagnostic Solutions for Patients Affected by Opioid and/or Stimulants Use Disorders (OUD/StUD) (R41/R42 Clinical Trial Optional) is a National Institutes of Health (NIH) Small Business Technology Transfer (STTR) funding opportunity (RFA-DA-24-038) aimed at moving new, evidence-based, FDA-regulated products toward commercialization for people affected by opioid use disorder and/or stimulant use disorder. The core purpose is to support small business concerns that are building real-world medical solutions that can be regulated by the FDA, with the broader goal of strengthening the response to the ongoing opioid and psychostimulant crisis and delivering tangible benefits to individuals, families, and communities.
The NOFO focuses on two main scientific and product-development tracks. The first is pharmacotherapeutics, which includes both small-molecule drug candidates and biologics intended to prevent, treat, or otherwise address OUD and/or StUD in a clinically meaningful way. The second track is medical therapeutic and diagnostic devices, which can include hardware-based devices as well as software as a medical device (SaMD). In practice, this means the program is open to a wide range of regulated product concepts, such as novel medications, biologic interventions, diagnostic tools, patient monitoring or support technologies, and device-driven therapeutic approaches, as long as the project is aligned with an FDA-regulated pathway and is grounded in evidence-based development.
A defining feature of the opportunity is its emphasis on commercialization-oriented R and D within the STTR framework, which typically involves a formal collaboration between a small business and a nonprofit research institution. The intent is not just early discovery, but translational development that positions a product for real adoption and impact, including work that advances performance validation, usability and feasibility, regulatory planning, and other steps that support eventual market entry. Clinical trials are optional under this announcement, meaning applicants can propose projects that do or do not involve a clinical study, depending on what is appropriate for the maturity and risk profile of the technology.
The announcement also explicitly encourages applications from small businesses that already have technologies on the market or in development for other indications and want to demonstrate that their existing FDA-regulated product could be repurposed, adapted, or extended to address OUD and/or StUD. That makes the program relevant not only to startups creating brand-new interventions, but also to companies with platforms, devices, diagnostics, digital health products, or therapeutic candidates that may translate well into substance use disorder care with additional targeted development and evidence generation.
Eligibility is limited to small businesses as the applicant organization type, consistent with STTR requirements. Non-domestic (non-U.S.) entities are not eligible to apply, and non-domestic components of U.S. organizations are also not eligible. However, foreign components may be permitted in certain circumstances as defined by the NIH Grants Policy Statement, so applicants with any international collaboration elements need to handle that carefully and follow NIH policy and the full NOFO details.
Key administrative details included in the posting are that this is a discretionary grant opportunity within the Education and Health activity category, associated with CFDA number 93.279, offered by NIH. The original application closing date listed is February 14, 2025. The award ceiling shown in the provided data is $300,000 (as listed), and the opportunity was created on April 18, 2023. Overall, the program is designed to push promising, regulated therapeutic and diagnostic innovations closer to clinical utility and commercialization for OUD and StUD, with an explicit public health motivation tied to the national overdose and stimulant crisis.Apply for RFA DA 24 038
- The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Developing Regulated Therapeutic and Diagnostic Solutions for Patients Affected by Opioid and/or Stimulants use Disorders (OUD/StUD) (R41/R42 Clinical Trial Optional)" 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 2023-04-18.
- Applicants must submit their applications by 2025-02-14. (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 $300,000.00 in funding.
- Eligible applicants include: Small businesses.
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| Ending the HIV Epidemic: Focus on Justice Populations with SUD-Data Coordination and Dissemination Center (UM1 Clinical Trial Optional) Apply for RFA DA 24 023 Funding Number: RFA DA 24 023 Agency: National Institutes of Health Category: Education, Health Funding Amount: $1,000,000 |
| Cancer Immunoprevention Network (CIP-Net) ?Research Projects (UG3/UH3 Clinical Trials Not Allowed) Apply for RFA CA 23 029 Funding Number: RFA CA 23 029 Agency: National Institutes of Health Category: Education, Health Funding Amount: $500,000 |
| Cancer Prevention, Detection, Diagnosis, and Treatment Technologies for Global Health (U01 Clinical Trial Optional) Apply for RFA CA 24 005 Funding Number: RFA CA 24 005 Agency: National Institutes of Health Category: Education, Health Funding Amount: $475,000 |
| SBIR Phase IIB Bridge Awards to Accelerate the Development of Cancer-Relevant Technologies Toward Commercialization (R44 Clinical Trial Optional) Apply for RFA CA 23 034 Funding Number: RFA CA 23 034 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
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| Translating Socioenvironmental Influences on Neurocognitive Development and Addiction Risk (TranSINDA) (R34 Clinical Trial Not Allowed) Apply for RFA DA 24 019 Funding Number: RFA DA 24 019 Agency: National Institutes of Health Category: Education, Health Funding Amount: $450,000 |
| Patient Engagement Resource Centers to Inform SUD Treatment Services Research (R24 Clinical Trial Optional) Apply for RFA DA 24 016 Funding Number: RFA DA 24 016 Agency: National Institutes of Health Category: Education, Health Funding Amount: $350,000 |
| Advancing Psychedelics Research for Treating Addiction (R01 Clinical Trial Not Allowed) Apply for RFA DA 24 028 Funding Number: RFA DA 24 028 Agency: National Institutes of Health Category: Education, Health Funding Amount: $350,000 |
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| Advancing Psychedelics Research for Treating Addiction (R61/R33 Basic Experimental Study with Humans Required) Apply for RFA DA 24 029 Funding Number: RFA DA 24 029 Agency: National Institutes of Health Category: Education, Health Funding Amount: $700,000 |
| Emergency Medicine Research Career Development Program in the Neurological Sciences (EMRCDP-NS) (K12 - No Independent Clinical Trial Allowed) Apply for PAR 23 151 Funding Number: PAR 23 151 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
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| Field-Deployable, Low-Cost Point-of-Need Approaches and Technologies to Lower the Barriers to Substance Use Disorders (SUD) Diagnosis and Treatment (R43/R44 Clinical Trial Optional) Apply for RFA DA 24 018 Funding Number: RFA DA 24 018 Agency: National Institutes of Health Category: Education, Health Funding Amount: $295,924 |
| Field-Deployable, Low-Cost Point-of-Need Approaches and Technologies to Lower the Barriers to Substance Use Disorders (SUD) Diagnosis and Treatment (R41/R42 Clinical Trial Optional) Apply for RFA DA 24 017 Funding Number: RFA DA 24 017 Agency: National Institutes of Health Category: Education, Health Funding Amount: $295,924 |
| Accelerating Behavioral and Social Science through Ontology Development and Use: Research Network Projects (U01 Clinical Trial Not Allowed) Apply for PAR 23 182 Funding Number: PAR 23 182 Agency: National Institutes of Health Category: Education, Health Funding Amount: $500,000 |
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