This National Institute on Drug Abuse (NIDA) grant supports the development of Clinical Outcome Assessments (COA) for Substance Use Disorders (SUD). The objective is to establish new FDA-qualified COAs as drug development tools, thereby accelerating the creation of effective treatments for opioid and stimulant use disorders. This funding opportunity utilizes a UG3/UH3 phased award mechanism. The initial two-year UG3 phase requires specific operational milestones. Successful completion, evaluated by NIDA, leads to the three-year UH3 phase. This aims to expand the array of FDA-qualified COAs, greatly facilitating SUD treatment development. A mandatory Plan for Enhancing Diverse Perspectives (PEDP) must be included for application consideration.
Opportunity ID: 351557
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-DA-25-028 |
| Funding Opportunity Title: | 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) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Education Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.279 — Drug Abuse and Addiction Research Programs |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Dec 19, 2023 |
| Last Updated Date: | Dec 19, 2023 |
| Original Closing Date for Applications: | Jul 09, 2024 |
| Current Closing Date for Applications: | Jul 09, 2024 |
| Archive Date: | Aug 14, 2024 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Private institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal governments (Federally recognized) For profit organizations other than small businesses County governments Public and State controlled institutions of higher education State governments City or township governments Small businesses Others (see text field entitled “Additional Information on Eligibility” for clarification) Independent school districts Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Special district governments Public housing authorities/Indian housing authorities |
| Additional Information on Eligibility: | 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. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | 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. |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-25-028.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH Grants Information
grantsinfo@nih.gov Email:grantsinfo@nih.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
Folder 351557 Full Announcement-RFA-DA-25-028 -> RFA-DA-25-028-Full-Announcement.pdf
Packages
| Agency Contact Information: | NIH Grants Information grantsinfo@nih.gov Email: grantsinfo@nih.gov |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| FORMS-H | Use for due dates on or after January 25, 2023 | PKG00284227 | Jun 09, 2024 | Jul 09, 2024 | View |
Package 1
Mandatory forms
351557 RR_SF424_5_0-5.0.pdf
351557 PHS398_CoverPageSupplement_5_0-5.0.pdf
351557 RR_OtherProjectInfo_1_4-1.4.pdf
351557 PerformanceSite_4_0-4.0.pdf
351557 RR_KeyPersonExpanded_4_0-4.0.pdf
351557 RR_Budget10_3_0-3.0.pdf
351557 PHS398_ResearchPlan_5_0-5.0.pdf
351557 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
351557 RR_SubawardBudget10_30_3_0-3.0.pdf
351557 PHS_AssignmentRequestForm_3_0-3.0.pdf
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