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

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Key Information

Due Date: July 5, 2029


Agency: United States Department of Health and Human Services


Source: Federal


Website: View Website


Funding Categories:

Funding Amount: Not Specified


Funding Type: Cooperative Agreement


Match Required: No


Status: Posted


Contact Info: NIAID_IICT_U01@mail.nih.gov
National Institute of Allergy and Infectious Diseases (NIAID) NIAID_IICT_U01@mail.nih.gov

Overview

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.
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Additional Info

Posted Date: June 16, 2026


Application Due Date: July 5, 2029


Estimated Award Date: Not Specified


Eligible Applicants:

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