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NIAID Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required)

National Institutes of Health · Opportunity number PAR-27-064

View the official notice on Grants.gov
993 days left (deadline Jul 5, 2029)

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 numberPAR-27-064
AgencyNational Institutes of Health
Department of Health and Human Services
Assistance listing (ALN, formerly CFDA)93.855
PostedJun 16, 2026
DeadlineJul 5, 2029
Cost sharing or matching requiredNo
Funding typeCooperative agreement
CategoryHealth
Last updated hereOct 15, 2026

Summary from the notice

This notice of funding opportunity (NOFO) encourages applications for implementation of investigator-initiated, milestone driven clinical trials that need enhanced oversight, and as applicable, include mechanistic studies. Mechanistic work in clinical trials may be of great value because it promotes the understanding of human diseases and the development of future therapeutic modalities. Support is available for clinical trials up to 5 years, as well as for extended clinical trials of 6- or 7-years.Investigators are encouraged to visit this NIH website for additional information about the overall mission and research areas of NIAID.Only one clinical trial may be proposed in each NIAID Clinical Trial Implementation Cooperative Agreement (U01) application. In accordance with NIH standard peer-review processes, the applications will be peer-reviewed, and only meritorious applications will be considered.

Who can apply

The official notice lists these applicant types as eligible:

  • Nonprofits without 501(c)(3) status (other than colleges)
  • Others named in the notice (see the eligibility text)
  • State governments
  • Independent school districts
  • Federally recognized tribal governments
  • Private colleges and universities
  • Special district governments
  • County governments
  • Other Native American tribal organizations
  • For-profit organizations other than small businesses
  • Public and Indian housing authorities
  • Nonprofits with 501(c)(3) status (other than colleges)
  • Small businesses
  • City or township governments
  • Public and state colleges and universities

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

Refer to Section III. Eligibility Information in the NOFO for additional information on eligibility.Foreign Organizations/International CollaborationsNon-domestic (non-U.S.) Entities (Foreign Organizations) are eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.Foreign components, as defined in the NIH Grants Policy Statement, are 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.

Past awards for this program

Totals for assistance listing 93.855 from public USASpending.gov data, as of Mar 26, 2026. Past awards do not predict future funding.

YearListingAwardsTotalAverage
2026 93.855 1 $1,062,954,652 $1,062,954,652

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