Developing Digital Therapeutics for Substance Use Disorders (UG3/UH3 Clinical Trial optional) | PAR 24 064

Opportunity Information: Apply for PAR 24 064

Developing Digital Therapeutics for Substance Use Disorders (UG3/UH3 Clinical Trial optional), PAR-24-064, is a National Institutes of Health cooperative agreement funding opportunity aimed at speeding up the creation and advancement of software-based treatments for substance use disorders. The focus is on clinical-grade digital therapeutics, meaning interventions delivered through mobile apps, web platforms, or other software systems that are designed and evaluated with the kind of rigor expected for medical products. The overall intent is to push promising digital tools to the next stage of development so they can become real-world treatment options, including, where appropriate, products that ultimately achieve FDA authorization. At the same time, the announcement recognizes that FDA authorization is not the only route to impact and dissemination, and it allows flexibility for applicants to propose other viable pathways for getting effective digital interventions into practice.

The FOA is structured around moving digital therapeutics forward along the development pipeline, from earlier-stage work through clinical evaluation. Applicants can propose pre-clinical development activities (for example, refining the intervention, improving usability and engagement, ensuring privacy and security, verifying technical performance, and establishing feasibility) and/or clinical development and testing. A key feature is that projects may involve entirely new digital therapeutics designed specifically for substance use disorders, or they may adapt or repurpose digital therapeutics originally developed for other health indications and test them for SUD treatment. The “clinical trial optional” designation signals that a clinical trial is allowed but not mandatory; teams can propose the study design that best fits the maturity of their product and the evidence needed to responsibly advance it.

Because the award mechanism is a cooperative agreement, NIH is expected to have substantial programmatic involvement during the project. In practice, that often means closer coordination with NIH staff than a standard grant, with milestones, go/no-go decision points, and active project stewardship intended to keep development moving efficiently and aligned with the program goals. The UG3/UH3 structure commonly supports a phased approach, where an initial stage focuses on development and preparation activities and a later stage supports more advanced testing and validation, although the exact expectations should be confirmed in the full FOA text and any companion notices.

Eligibility is broad and includes many types of organizations that could realistically build and test digital therapeutics, such as universities and colleges (public, state-controlled, and private), nonprofits (with or without 501(c)(3) status), for-profit organizations (including small businesses), and various government entities (state, county, city/township, special districts, independent school districts, and eligible federal agencies). Tribal entities are explicitly included, covering federally recognized tribal governments as well as other tribal organizations. The announcement also highlights additional eligible applicant categories such as HBCUs, Hispanic-serving institutions, Tribal Colleges and Universities, AANAPISIs, Alaska Native and Native Hawaiian-serving institutions, faith-based or community-based organizations, U.S. territories or possessions, and even non-U.S. (foreign) organizations and regional organizations, signaling an interest in attracting a diverse set of applicants and settings.

From a practical standpoint, the projects NIH is trying to catalyze here are those that can plausibly lead to safe, effective, and scalable digital treatments for substance use disorders. That implies attention not just to clinical outcomes, but also to real-world implementation considerations like engagement and retention, accessibility, interoperability with care systems when relevant, data protection, and a dissemination plan consistent with the intended regulatory and market pathway. The FOA sits in the health and education activity category and is associated with CFDA number 93.279. The opportunity was created on February 27, 2024, and lists an original closing date of November 19, 2026, giving prospective applicants a multi-year window to prepare a competitive development and testing proposal.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Developing Digital Therapeutics for Substance Use Disorders (UG3/UH3 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 2024-02-27.
• Applicants must submit their applications by 2026-11-19. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

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