Developing Digital Therapeutics for Substance Use Disorders (UG3/UH3 Clinical Trial optional)
ID: 352661Type: Posted
Overview

Buyer

National Institutes of Health (HHS-NIH11)

Eligible Applicants

Others

Funding Category

Health

Funding Instrument

Cooperative Agreement

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes

Original Source

https://grants.gov/search-results-detail/352661

Additional Information

http://grants.nih.gov/grants/guide/pa-files/PAR-24-064.html
Timeline
    Description

    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.

    Point(s) of Contact
    grantsinfo@nih.gov
    Files
    Title
    Posted
    PAR-24-064-Full-Announcement.html
    PAR-24-064.html
    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.
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