Cooperative AgreementPostedDiscretionary

Developing Digital Therapeutics for Substance Use Disorders (UG3/UH3 Clinical Trial optional)

National Institutes of Health
PAR-24-064
Application Deadline
Nov 19, 2026
241 days left
Days Remaining
241
Until deadline
Award Ceiling
Total Program Funding

Grant Opportunity Analysis

The National Institutes of Health (NIH) is offering a funding opportunity titled "Developing Digital Therapeutics for Substance Use Disorders (UG3/UH3 Clinical Trial optional)" aimed at accelerating the development of digital therapeutics (DTx) to treat substance use disorders (SUDs). This initiative seeks to support the creation of clinical-grade mobile, web, or software-based platforms that are safe and effective for SUD treatment, with a focus on obtaining FDA authorization for these interventions. The funding follows a two-phase structure, with the UG3 phase allowing for up to two years of initial development and milestone achievement, and the UH3 phase extending up to three years based on successful progression, with no budget limit for the latter phase and a cap of $500,000 for the UG3 phase. Interested applicants, including various educational institutions and organizations, must submit their proposals by February 26, 2024, and can reach out to NIH Grants Information at grantsinfo@nih.gov for further inquiries.

Eligible Applicants

Others
Additional Eligibility Information

Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession.

Grant Documents

2 Files
PAR-24-064-Full-Announcement.html
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PAR-24-064.html
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AI Summary
The Department of Health and Human Services, through the National Institute on Drug Abuse (NIDA), is issuing a funding opportunity for developing Digital Therapeutics (DTx) aimed at treating Substance Use Disorders (SUDs). The funding—identified by opportunity number PAR-24-064—focuses on accelerating DTx development, with an emphasis on obtaining FDA authorization. The grant follows a two-phase structure: the UG3 phase (up to two years) for initial development and milestone achievement, and the UH3 phase (up to three years) contingent upon the successful progression of the UG3 phase. Key objectives include advancing clinical-grade mobile, web, or software interventions tailored to SUD treatment. Applicants must devise measurable milestones and regulatory strategies while partnering with relevant FDA offices for guidance. There will be no limit on the budget for the UH3 phase, with specified annual budgets capped at $500,000 for the UG3 phase. The program encourages diverse applicants, including higher education institutions, nonprofits, and for-profit organizations. The deadline for submission is February 26, 2024, with various review metrics assessing significance, innovation, and research approach. This NOFO exemplifies a commitment to innovative solutions for addressing the critical public health issue of substance use disorders.

Related Grant Opportunities

Project Timeline

postedOriginal Opportunity PostedFeb 27, 2024
deadlineApplication DeadlineNov 19, 2026
expiryArchive DateDec 25, 2026

Funding Details

No cost sharing required

Agency & Classification

Agency
National Institutes of Health(HHS-NIH11)
Funding Category
Health
Funding Instrument
Cooperative Agreement

Grantor Contact

CFDA Numbers

93.279

Official Sources