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

Federal funding opportunity PAR-27-064 from National Institutes of Health (Department of Health and Human Services).

Apply on Grants.gov →Application closes July 5, 2029

Posted: June 16, 2026
Closes: July 5, 2029
Cost sharing: No
Instrument: Cooperative Agreement
Assistance listing: 93.855
Category: Health
Archives: September 5, 2029

Program funding history

Awards made under Assistance Listing 93.855 across FY2024–FY2026, from public federal spending records.

FY2024 obligated: $4.1B
FY2025 obligated: $4.2B
FY2026 (to date) obligated: $3.1B
Awards in window: 14,719

Top recipients: Fred Hutchinson Cancer Center, The Johns Hopkins University, Regents of the University of California, San Francisco, the, Duke University, Washington University, the

Source: USAspending.gov · refreshed August 2026

Synopsis

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

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

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.

How to apply

Applications go through the official government listing. Grants Radar links you straight to the source — applying is free.

View on Grants.gov

Agency contact: National Institutes of Health · [email protected] · 301-402-2541

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