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
Timeline
  1. 1
    Forecast Posted Not available
  2. 2
    Forecast Due Not available
  3. 3
    Posted Dec 18, 2023 12:00 AM
  4. 4
    Due Jul 9, 2024 12:00 AM
Description

The National Institutes of Health (NIH) has posted a grant opportunity titled "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)". This funding opportunity aims to support the development of Clinical Outcome Assessments (COA) for Substance Use Disorders (SUD) and progress them into the FDA drug development tool qualification program. The grant utilizes the UG3/UH3 Phased Innovation Awards Cooperative Agreement grant mechanism, consisting of two phases. The COA development plan should cover both UG3 and UH3 phases, with the UG3 phase requiring a set of operational milestones to be completed within 2 years. Upon successful completion of the UG3 phase, the project transitions to the UH3 phase, which is funded for an additional three years. The goal of this grant is to expand the armamentarium of COA that are FDA qualified as drug development tools for SUDs, ultimately facilitating the development of treatments for these disorders. Applicants are required to include a Plan for Enhancing Diverse Perspectives (PEDP) as part of the application, which will be evaluated during the scientific and technical peer review process. Failure to include a PEDP will result in the application being considered incomplete and withdrawn. Interested applicants are encouraged to carefully review the NOFO instructions and PEDP guidance material. For more information and to apply, visit the grant opportunity website. For any inquiries, contact NIH Grants Information at grantsinfo@nih.gov.

Point(s) of Contact
Files
Title
Posted
4/10/2024
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