Opportunity Information: Apply for RFA DA 23 018
The Enabling SUD Digital Therapeutics Research to Improve Payor Adoption (R44 - Clinical Trial Only) opportunity (RFA-DA-23-018) is a discretionary National Institutes of Health (NIH) grant designed to push substance use disorder (SUD) digital therapeutics closer to real-world uptake by focusing on the evidence that matters most to payors. The core idea is that many digital therapeutics may show promise clinically, but still struggle to gain broad coverage or reimbursement without strong, decision-ready data. This program specifically targets that gap by funding clinical trials intended to produce convincing results that can support payor adoption, meaning data that can help insurers and other payors feel confident about coverage decisions and integration into routine care.
The funding is structured as an R44, which is an NIH Small Business Innovation Research (SBIR) mechanism typically used when a small business is moving beyond early development and into more advanced evaluation, often with an eye toward commercialization and market entry. In this case, the emphasis is explicitly on clinical trials only, signaling that applicants are expected to be ready to run a rigorous clinical study rather than just building or refining a product. The end goal is not simply to demonstrate that a digital therapeutic can work in a controlled setting, but to generate the type of outcomes evidence that payors often require, such as meaningful clinical impact, real-world relevance, and data that supports the value proposition of the intervention.
Eligibility is limited to small businesses, aligning with the SBIR focus on supporting innovation that can be brought to market. Foreign participation is restricted in a very direct way: non-U.S. entities (foreign institutions) cannot apply, and non-U.S. components of U.S. organizations are also not eligible to apply. However, foreign components as defined under the NIH Grants Policy Statement may be allowed, which generally means limited, well-justified involvement of a foreign site or collaborator could be permissible under specific conditions, but the applicant organization itself must be U.S.-based and meet SBIR small business requirements.
Key administrative details include an original closing date of November 15, 2022, a creation date of June 29, 2022, and an award ceiling of $2,500,000. The opportunity is listed under CFDA number 93.279 and falls under education and health as the funding activity category. The sponsoring agency is NIH, and the broad public health aim is to strengthen the evidence base for SUD digital therapeutics in a way that improves the likelihood they will be covered, reimbursed, and used at scale, rather than remaining stuck at the pilot or niche-adoption stage.Apply for RFA DA 23 018
- The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Enabling SUD Digital Therapeutics Research to Improve Payor Adoption (R44- Clinical Trial Only)" 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 2022-06-29.
- Applicants must submit their applications by 2022-11-15. (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 $2,500,000.00 in funding.
- Eligible applicants include: Small businesses.
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Frequently Asked Questions (FAQs)
What is this grant opportunity?
The opportunity is titled Enabling SUD Digital Therapeutics Research to Improve Payor Adoption (R44 - Clinical Trial Only) (RFA-DA-23-018). It is a discretionary National Institutes of Health (NIH) funding opportunity designed to support clinical trials of substance use disorder (SUD) digital therapeutics, with a specific focus on generating evidence that improves the chances of payor coverage and reimbursement.
What is the main goal of the program?
The main goal is to move promising SUD digital therapeutics closer to real-world uptake by funding clinical trials that produce decision-ready evidence for payors (such as insurers). The program is aimed at closing the gap between clinical promise and broad adoption by focusing on outcomes and evidence that can support coverage decisions and routine care integration.
Why does the program emphasize "payor adoption"?
The program is built around the idea that some digital therapeutics may look clinically promising but still struggle to achieve broad coverage or reimbursement. Payors often require strong, convincing evidence that the intervention has meaningful impact, real-world relevance, and a clear value proposition. This opportunity funds research intended to generate the kind of evidence that payors typically want to see.
What does "R44" mean in this context?
R44 is an NIH Small Business Innovation Research (SBIR) mechanism. It is commonly used when a small business is moving beyond early development into more advanced evaluation, often with commercialization and market entry in view. For this opportunity, the R44 structure aligns with the emphasis on later-stage testing and evidence generation.
What does "Clinical Trial Only" mean?
"Clinical Trial Only" indicates the opportunity is specifically intended to fund applicants who are ready to run a rigorous clinical study. The emphasis is not on building or refining a product at an early stage, but on conducting a clinical trial designed to produce persuasive outcomes evidence relevant to payors.
What kinds of projects is this opportunity trying to support?
Based on the description, the opportunity supports clinical trials of SUD digital therapeutics that are intended to produce evidence that matters most to payors, such as meaningful clinical impact, real-world relevance, and results that strengthen the intervention's value proposition for coverage and reimbursement.
Who is eligible to apply?
Eligibility is limited to small businesses, consistent with the SBIR focus on supporting innovations that can be brought to market.
Are non-U.S. organizations allowed to apply?
No. The information provided states that non-U.S. entities (foreign institutions) cannot apply.
Can a U.S. organization apply if it has a non-U.S. component?
Non-U.S. components of U.S. organizations are stated as not eligible to apply. The applicant organization itself must be U.S.-based and meet SBIR small business requirements.
Is any foreign involvement allowed at all?
Possibly. The description notes that foreign components (as defined under the NIH Grants Policy Statement) may be allowed under specific conditions. This generally implies limited and well-justified foreign site or collaborator involvement could be permissible, but it does not change the requirement that the applicant organization must be U.S.-based and eligible as an SBIR small business.
What agency is sponsoring this opportunity?
The sponsoring agency is the National Institutes of Health (NIH).
What is the award ceiling?
The award ceiling listed is $2,500,000.
What is the CFDA number associated with this opportunity?
The opportunity is listed under CFDA 93.279.
What is the funding activity category?
The funding activity category is listed as education and health.
When was the opportunity created?
The creation date provided is June 29, 2022.
What was the original closing date?
The original closing date provided is November 15, 2022.
What kind of evidence is this program trying to generate?
The description emphasizes evidence that payors can use for coverage decisions, including outcomes that demonstrate meaningful clinical impact, real-world relevance, and support for the value proposition (evidence that helps justify reimbursement and integration into routine care).
Is the goal only to show that a digital therapeutic works clinically?
No. The stated goal goes beyond controlled-setting effectiveness. The program is specifically aimed at producing evidence that improves the likelihood of coverage, reimbursement, and scale, rather than leaving products stuck in pilot stages or niche adoption.
What is the broader public health aim of this opportunity?
The broader public health aim is to strengthen the evidence base for SUD digital therapeutics in ways that improve the likelihood they will be covered and used at scale, supporting broader access through payor adoption and routine-care integration.
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