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

Open

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

PostedJun 16, 2026
Closing dateJul 5, 2029
Award ceilingNot listed
Expected awardsNot listed
From Grants.gov

Eligibility

Nonprofits are listed as eligible applicants.

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

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.

Description

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.

Funding

Total program fundingNot listed
Award floorNot listed
Award ceilingNot listed
CategoryHealth
Assistance listing93.855

Official sources

Last verified on Grants.gov Nov 4, 2026. Grantvello is not affiliated with Grants.gov or National Institutes of Health. The notice on Grants.gov is the binding text.