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)

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The purpose of this funding opportunity is to support the development of Clinical Outcome Assessments (COA) for Substance Use Disorders (SUD). The COA development plan is expected to progress into the FDA drug development tool qualification program. This notice of funding opportunity (NOFO) utilizes the UG3/UH3Phased Innovation Awards Cooperative Agreement grant mechanism that includes two phases. The applications responding to this NOFO should contain a COA development plan that will cover both UG3 and UH3 phases. In the first 2-year UG3 phasethe project must have a set of operational milestones to be completed by the end of this period. Once NIDA program has evaluated the progress of the UG3 phase and determined that the UG3 phase has been successfully completed, it transitions to the UH3 phase to be funded for three additional years.The goal of this NOFO is to expand the armamentarium of COA that are FDA qualified as drug development tool (DDT) in the context of use (COI) of a SUD. Achieving this goal will greatly facilitate the development of treatments for SUDs. This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP), which will be assessed as part of the scientific and technical peer review evaluation. Applications that fail to include a PEDP will be considered incomplete and will be withdrawn. Applicants are strongly encouraged to read the NOFO instructions carefully and view the available PEDP guidance material.

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