# 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)

Source: https://welltoldgrants.com/grants/rfa-da-25-028-development-of-clinical-outcome-assessments-as-new-fda/  
Official notice: https://www.grants.gov/search-results-detail/351557

> National Institutes of Health offered grants to nonprofits, colleges and universities, state and local governments, tribes, small businesses and businesses. Applications closed on July 9, 2024.

| Field | Value |
|---|---|
| Opportunity number | RFA-DA-25-028 |
| Agency | National Institutes of Health |
| Status | Forecast |
| Deadline | July 9, 2024 |
| Award ceiling | not stated |
| Award floor | not stated |
| Expected awards | not stated |
| Total funding | not stated |
| Cost sharing | not required |
| Assistance Listings | 93.279 |

## Who can apply

- State governments
- County governments
- City or township governments
- Special district governments
- Independent school districts
- Public and State controlled institutions of higher education
- Native American tribal governments (Federally recognized)
- Public housing authorities/Indian housing authorities
- Native American tribal organizations (other than Federally recognized tribal governments)
- Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
- Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
- Private institutions of higher education
- For profit organizations other than small businesses
- Small businesses
- Others (see text field entitled "Additional Information on Eligibility" for clarification)

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.

## What the grant funds

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.

## Questions people ask

### Is RFA-DA-25-028 still open?

No. It closed on July 9, 2024.

### Who can apply for 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)?

National Institutes of Health accepted applications from nonprofits, colleges and universities, state and local governments, tribes, small businesses and businesses. The notice adds further conditions, so read its eligibility section.

### What is the deadline for 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)?

Closed July 9, 2024. Applications are no longer accepted; the program's newer notices are on this page when there are any.

### Who has been funded under RFA-DA-25-028?

NIH RePORTER lists 4 projects funded under RFA-DA-25-028 in fiscal 2025 to 2026, at 4 institutions. The most were at Johns Hopkins University, McLean Hospital, City College of New York.

### Who has won Drug Use and Addiction Research Programs grants before?

The largest recipients over five fiscal years were Yale Univ, The Johns Hopkins University, University of California, San Diego. The program made 5,071 awards worth $7.3 billion in that time.