First in Human and Early Stage Clinical Trials of Novel Investigational Drugs or Neuromodulatory Device-based Interventions for Psychiatric Disorders (U01 Clinical Trial Required)
National Institutes of Health · Opportunity number PAR-25-180
Details summarized from the official notice as of Oct 15, 2026. Always confirm eligibility, deadlines and requirements in the official notice before applying.
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Key facts
| Opportunity number | PAR-25-180 |
|---|---|
| Agency | National Institutes of Health Department of Health and Human Services |
| Assistance listing (ALN, formerly CFDA) | 93.242 |
| Posted | Nov 26, 2024 |
| Deadline | Oct 15, 2027 |
| Cost sharing or matching required | No |
| Funding type | Cooperative agreement |
| Category | Health |
| Last updated here | Oct 15, 2026 |
Summary from the notice
Who can apply
The official notice lists these applicant types as eligible:
- County governments
- Public and Indian housing authorities
- Private colleges and universities
- Federally recognized tribal governments
- Others named in the notice (see the eligibility text)
- Nonprofits without 501(c)(3) status (other than colleges)
- Public and state colleges and universities
- State governments
- Small businesses
- City or township governments
- For-profit organizations other than small businesses
- Nonprofits with 501(c)(3) status (other than colleges)
- Special district governments
- Independent school districts
- Other Native American tribal organizations
Who should take a closer look
- Small businesses
- Nonprofits
- Colleges and universities
- State governments
- Local governments
- Tribal governments and organizations
- Larger for-profit companies
Not listed as eligible
- Individuals
Unless the eligibility text in the notice names you, this opportunity is probably not for you.
Eligibility details from the notice
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; Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
Registrations you will likely need
Most applications submitted through Grants.gov need the following. Registration can take several weeks, so start early. The notice lists the exact requirements.
- SAM.gov registration for your organization, which also gives you a Unique Entity ID (UEI). Registration is free.
- A Login.gov account, which Grants.gov uses for sign-in.
- A Grants.gov applicant registration linked to your organization's UEI.
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