Development of Clinical Outcome Assessments as New FDA-Qualified Drug Development Tools to Accelerate Therapeutics Development for Opioid and Stimulant Use Disorders (UG3/UH3 Clinical Trial Optional)
ID: 351557Type: 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/351557

Additional Information

http://grants.nih.gov/grants/guide/rfa-files/RFA-DA-25-028.html
Timeline
    Description

    The National Institutes of Health (NIH), through the National Institute on Drug Abuse (NIDA), is inviting applications for the development of Clinical Outcome Assessments (COA) aimed at enhancing therapeutic development for Opioid and Stimulant Use Disorders (OUD and SUD). Applicants are required to submit a COA development plan that encompasses two phases: an initial two-year UG3 phase followed by a potential three-year UH3 phase, contingent upon the successful achievement of operational milestones. This funding opportunity underscores the urgent need for validated COAs in the treatment of substance use disorders and emphasizes the importance of inclusivity in research through the mandatory inclusion of a Plan for Enhancing Diverse Perspectives (PEDP). Up to $2.5 million is available for three to five awards, with a maximum budget of $500,000 per year. The submission period opens on June 9, 2024, and closes on July 10, 2024. For further inquiries, interested parties can contact NIH Grants Information at grantsinfo@nih.gov.

    Point(s) of Contact
    grantsinfo@nih.gov
    Files
    Title
    Posted
    RFA-DA-25-028-Full-Announcement.html
    RFA-DA-25-028.html
    The National Institutes of Health (NIH), through the National Institute on Drug Abuse (NIDA), is seeking applications for the development of Clinical Outcome Assessments (COA) aimed at enhancing therapeutic development for Opioid and Stimulant Use Disorders (OUD and SUD). This funding opportunity, designated as UG3/UH3, encourages projects to create COAs that can qualify as Drug Development Tools (DDT) per FDA guidelines. Applicants must deliver a COA development plan split into two phases, with an initial two-year UG3 phase followed by a potential three-year UH3 phase, contingent on successful milestone achievement. A vital requirement is the inclusion of a Plan for Enhancing Diverse Perspectives (PEDP) to foster inclusivity in research. Up to $2.5 million is available for three to five awards, with a maximum budget of $500,000 per year. Key dates include a submission opening on June 9, 2024, with a closing date of July 10, 2024. This initiative underscores the NIH's commitment to address the urgent need for validated COAs in the treatment of substance use disorders, engaging diverse perspectives throughout the research process.
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