Opportunity Information: Apply for RFA DA 25 048
The National Institutes of Health (NIH) is offering a Small Business Innovation Research/Small Business Technology Transfer style funding opportunity under RFA-DA-25-048, titled "Seeking Products to Address Social Needs impacting Substance Use Disorders (SUD) (R43/R44 Clinical Trial Optional)." This is a discretionary grant opportunity designed specifically to help small business concerns move practical, market-ready technologies toward commercialization. The focus is on products that address health-related social needs that contribute to or worsen substance use disorders, with one clear boundary: projects must target SUDs other than alcohol use disorder.
At its core, this opportunity is about translating ideas into deployable solutions that can reduce barriers and improve outcomes for people affected by SUD by tackling upstream social and environmental factors. While the notice text provided does not list specific social needs, NIH use of the term "health-related social needs" generally refers to concrete, individual-level needs that sit within broader social determinants of health, such as housing instability, food insecurity, transportation challenges, employment and income barriers, safety, access to health and social services, and related navigation and support gaps. The intent is not just to study these issues, but to develop technologies that can be commercialized and used in real-world settings to mitigate them in ways that ultimately improve prevention, treatment engagement, retention, recovery supports, and other SUD-related outcomes.
The funding mechanism is R43/R44, which corresponds to the SBIR phased approach, where Phase I (R43) typically supports early feasibility and proof-of-concept and Phase II (R44) supports further development, refinement, and steps toward commercialization. The listing specifies "Clinical Trial Optional," meaning applicants may propose work that includes a clinical trial if it is appropriate for the product and stage of development, but a clinical trial is not required. This is important for product developers because some technologies may need pilot testing in clinical or community environments, while others may be better suited for usability testing, implementation pilots, or technical validation that does not meet NIH's definition of a clinical trial.
Eligibility is limited to small businesses. Non-U.S. (foreign) institutions are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible to apply. However, the notice notes that "foreign components," as defined by the NIH Grants Policy Statement, may be allowable in some cases, which typically means a U.S. small business applicant might include certain limited foreign activities or collaborations if they are well-justified and meet NIH policy requirements. Anyone considering an international partnership would need to read the full Notice of Funding Opportunity carefully to confirm what is permissible and what documentation is required.
Administratively, this opportunity is offered by NIH and is categorized under education and health, with CFDA number 93.279. The original closing date is March 13, 2026, and the record shows an award ceiling of $295,924. The posting indicates an expected awards field but does not provide a number in the supplied data, so applicants should consult the full announcement for information on anticipated award counts, budget guidance by phase, and any institute-specific priorities.
In practical terms, the best fit applicants are U.S.-based small businesses that already have a product concept or prototype and can clearly explain how their technology will address a defined social need that affects SUD risk or recovery, why it is likely to work in the intended setting (for example, clinics, community organizations, justice settings, mobile outreach, or home-based support), and how it can realistically reach a market. Because NIH emphasizes commercialization in SBIR/STTR-style opportunities, strong applications typically pair a credible technical development plan with a clear path to adoption and sustainability, including an understanding of the customer (health systems, payers, community providers, state agencies, employers, or other stakeholders), the reimbursement or purchasing pathway, regulatory considerations if relevant, and a realistic plan for scaling beyond the grant period.
For the exact scope, review criteria, required components, and any topic-specific instructions, the full Notice of Funding Opportunity is the authoritative source, especially since eligibility nuances (including foreign component rules) and phase-specific expectations are usually spelled out in detail there.Apply for RFA DA 25 048
- The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Seeking Products to Address Social Needs impacting Substance Use Disorders (SUD) (R43/R44 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 2023-09-28.
- Applicants must submit their applications by 2026-03-13. (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 $295,924.00 in funding.
- Eligible applicants include: Small businesses.
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Frequently Asked Questions (FAQs)
1) What is the name and ID of this funding opportunity?
This opportunity is offered by the National Institutes of Health (NIH) under RFA-DA-25-048 and is titled "Seeking Products to Address Social Needs impacting Substance Use Disorders (SUD) (R43/R44 Clinical Trial Optional)."
2) What type of grant mechanism is this?
It uses the SBIR phased mechanism R43/R44. Phase I (R43) generally supports early feasibility and proof-of-concept work, while Phase II (R44) supports further development, refinement, and steps toward commercialization.
3) What is NIH looking to fund through this opportunity?
NIH is seeking practical, market-ready technologies that can be moved toward commercialization and that address health-related social needs that contribute to or worsen substance use disorders (SUD). The intent is to translate ideas into deployable solutions that reduce barriers and improve SUD-related outcomes by addressing upstream social and environmental factors.
4) Is this opportunity focused on research or product development?
Based on the description provided, it is oriented toward product development with an emphasis on commercialization. The goal is not simply to study social needs, but to develop technologies that can be deployed in real-world settings and ultimately reach a market.
5) Which substance use disorders are within scope?
The focus is on SUDs other than alcohol use disorder. Projects must not target alcohol use disorder.
6) What does "health-related social needs" mean in this context?
The notice text provided does not list a specific set of needs, but it explains that NIH generally uses the term to refer to concrete, individual-level needs within broader social determinants of health. Examples described include housing instability, food insecurity, transportation challenges, employment and income barriers, safety, access to health and social services, and related navigation and support gaps.
7) What kinds of outcomes or impacts are these products expected to support?
The opportunity is aimed at technologies that mitigate social needs in ways that improve SUD-related outcomes such as prevention, treatment engagement, retention, recovery supports, and related outcomes.
8) Are clinical trials required?
No. The opportunity is labeled "Clinical Trial Optional," meaning a clinical trial may be included if appropriate for the product and its development stage, but it is not required.
9) If clinical trials are optional, what other kinds of testing might be relevant?
Depending on the technology, the description indicates products may be suited for pilot testing in clinical or community environments, usability testing, implementation pilots, or technical validation that does not meet NIH's definition of a clinical trial.
10) Who is eligible to apply?
Eligibility is limited to small businesses. The description emphasizes that this is designed specifically to help small business concerns move technologies toward commercialization.
11) Can non-U.S. (foreign) institutions apply?
No. Non-U.S. (foreign) institutions are not eligible to apply.
12) Can a U.S. organization include non-U.S. components?
No. Non-U.S. components of U.S. organizations are also not eligible to apply, as stated in the information provided.
13) Are any international collaborations allowed at all?
The description notes that "foreign components," as defined by the NIH Grants Policy Statement, may be allowable in some cases. This typically means a U.S. small business applicant might include limited foreign activities or collaborations if well-justified and compliant with NIH policy requirements. Applicants considering international involvement are directed to the full Notice of Funding Opportunity for the authoritative rules and required documentation.
14) Which federal agency is sponsoring this opportunity?
The sponsoring agency is the National Institutes of Health (NIH).
15) How is this opportunity categorized?
The opportunity is categorized under education and health.
16) What is the CFDA number associated with this opportunity?
The CFDA number listed is 93.279.
17) What is the application deadline?
The original closing date listed is March 13, 2026.
18) What is the maximum award amount mentioned in the listing?
The record shows an award ceiling of $295,924.
19) How many awards will NIH make under this opportunity?
The supplied information indicates an expected awards field exists but does not provide a number. Applicants should consult the full announcement for anticipated award counts.
20) What kinds of applicants are a good fit for this opportunity?
The description suggests the best fit is U.S.-based small businesses that already have a product concept or prototype and can clearly explain (a) the defined social need being addressed, (b) how the technology will reduce barriers or improve SUD-related outcomes, (c) why it is likely to work in the intended setting, and (d) how it can realistically reach a market.
21) What kinds of real-world settings are envisioned for deployment or testing?
Examples provided include clinics, community organizations, justice settings, mobile outreach, and home-based support environments.
22) What does NIH generally expect regarding commercialization in SBIR-style awards?
The description states that NIH emphasizes commercialization. Strong applications typically combine a credible technical development plan with a clear path to adoption and sustainability, including understanding the customer and how the product will be purchased or reimbursed.
23) Who might be the customer or buyer for a commercialized product?
The description lists potential stakeholders such as health systems, payers, community providers, state agencies, employers, or other relevant purchasers/adopters depending on the product.
24) Should applicants address reimbursement, purchasing pathways, or regulatory considerations?
Yes. The description notes that strong commercialization-focused applications often address reimbursement or purchasing pathways and regulatory considerations (if relevant), along with a realistic plan to scale beyond the grant period.
25) Where should applicants look for the authoritative requirements and review criteria?
The full Notice of Funding Opportunity is identified as the authoritative source for exact scope, review criteria, required components, topic-specific instructions, eligibility nuances (including foreign component rules), and phase-specific expectations.
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| Comprehensive Partnerships to Advance Cancer Health Equity (CPACHE) (U54 Clinical Trial Optional) Apply for PAR 23 308 Funding Number: PAR 23 308 Agency: National Institutes of Health Category: Education, Health Funding Amount: $1,700,000 |
| Revision Applications for Validation of Biomarker Assays Developed Through NIH-Supported Research Grants (R01 Clinical Trial Not Allowed) Apply for PAR 24 047 Funding Number: PAR 24 047 Agency: National Institutes of Health Category: Education, Health Funding Amount: $150,000 |
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| Translational Research Toward Development of a Kaposi Sarcoma Herpesvirus (KSHV) Vaccine (U01 Clinical Trial Optional) Apply for RFA CA 24 006 Funding Number: RFA CA 24 006 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Applying Imaging Pipelines for Spatial Characterization of Cellular Interactions in HIV-related CNS Pathology and/or Substance Use (R61/R33 Clinical Trial Not Allowed) Apply for RFA DA 24 030 Funding Number: RFA DA 24 030 Agency: National Institutes of Health Category: Education, Health Funding Amount: $300,000 |
| Targeting Inflammasomes in HIV and Substance Use (R01 Clinical Trial Not Allowed) Apply for RFA DA 25 012 Funding Number: RFA DA 25 012 Agency: National Institutes of Health Category: Education, Health Funding Amount: $500,000 |
| Targeting Inflammasomes in HIV and Substance Use (R21 Clinical Trial Not Allowed) Apply for RFA DA 25 013 Funding Number: RFA DA 25 013 Agency: National Institutes of Health Category: Education, Health Funding Amount: $275,000 |
| Tools for decentralized clinical trials for substance use disorder (R43/R44 Clinical Trials Optional) Apply for RFA DA 25 052 Funding Number: RFA DA 25 052 Agency: National Institutes of Health Category: Education, Health Funding Amount: $295,924 |
| Tools for Decentralized Clinical Trials for Substance Use Disorder (R41/R42 Clinical Trials Optional) Apply for RFA DA 25 051 Funding Number: RFA DA 25 051 Agency: National Institutes of Health Category: Education, Health Funding Amount: $1,972,828 |
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