NINDS Exploratory Clinical Trials (UG3/UH3 Clinical Trial Required)
- Posted
- April 18, 2022
- Closed
- November 12, 2024
- Cost sharing
- No
- Instrument
- Cooperative Agreement
- Assistance listing
- 93.853
- Category
- Health
- Archives
- December 12, 2024
Program funding history
Awards made under Assistance Listing 93.853 across FY2025–FY2027, from public federal spending records.
- FY2025 obligated
- $1.8B
- FY2026 obligated
- $2B
- FY2027 (to date) obligated
- $0
- Awards in window
- 8,124
Top recipients: The General Hospital Corporation, Regents of the University of California, San Francisco, the, The Johns Hopkins University, Regents of the University of Michigan, Washington University, the
Source: USAspending.gov · refreshed October 2026 · Program page: awards, recipients and the opportunities under this listing →
Synopsis
The purpose of this Funding Opportunity Announcement (FOA) is to encourage grant applications for investigator-initiated exploratory clinical trials to the National Institute of Neurological Disorders and Stroke (NINDS). The trials must address questions within the mission and research interests of the NINDS and may include Phase 1 and 2 studies of drugs and biologics, feasibility studies of devices, and early studies of surgical, behavioral or rehabilitation therapies. All exploratory trials must contribute to the justification for and provide some of the data required to inform a future trial to establish efficacy (such as a Phase 3, Phase 4 or Pivotal trial). This FOA uses the UG3/UH3 mechanism. Only projects that provide satisfactory progress in the UG3 phase may move to the UH3 phase, as outlined below. For a drug, biologic or device that has not completed a Phase 1/Early Feasibility trial: The UG3 mechanism will be used to plan and execute the Phase I trial(s). If Phase 1 trials are successful, the UG3 will also include the planning phase of a Phase 2 trial. The UH3 mechanism will then support the execution of the Phase 2 clinical trial. Transition to the UH3 will depend on successfully reaching agreed upon milestones. For a drug, biologic or device that has successfully completed the Phase 1/Early Feasibility trial(s), do not use this FOA. Instead use the Companion FOA XXX. For genetic studies, do not use this FOA. Instead, use FOA XXX.
Who can apply
- Special district governments
- Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
- Public housing authorities/Indian housing authorities
- Private institutions of higher education
- Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
- City or township governments
- State governments
- County governments
- Independent school districts
- Native American tribal governments (Federally recognized)
- For profit organizations other than small businesses
- Small businesses
- Others (see text field entitled "Additional Information on Eligibility" for clarification)
- Public and State controlled institutions of higher education
- Native American tribal organizations (other than Federally recognized tribal governments)
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.
The official record
Grants.gov published the official terms and dates of this opportunity; this page keeps them as they were listed.
View on Grants.gov Full announcement
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