The National Institutes of Health (NIH) intends to publish a Notice of Funding Opportunity (NOFO) to solicit applications that propose early to definitive clinical trials. Trials testing drugs, devices, biologics, procedures, behavioral, social, economic, health services, or other biomedical or non-pharmacological interventions are of interest to this initiative. The trials should align with the research mission of the participating Institutes, Centers, and Offices (ICOs) of the NIH. 

The NOFO will utilize the R61/R33 activity code, a bi-phasic, milestone-driven award. The R61 phase provides support for planning activities, and the R33 phase provides support for a clinical trial, with a maximum project period of 7 years.  

Applications are not being solicited at this time. This notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and relevant projects. Investigators with expertise in clinical trial planning, design, implementation, intervention development, and/or stakeholder engagement are encouraged to consider applying for the NOFO. 

Nonprofit

• Nonprofits non-higher education without 501(c)(3)
• Other Native American tribal organizations
• Nonprofits non-higher education with 501(c)(3)

Government

• Public and Indian housing authorities
• County governments
• Federally recognized Native American tribal governments
• Special district governments
• City or township governments
• State governments

Business

• Small businesses
• For-profit organizations other than small businesses

Education

• Public and state institutions of higher education
• Private institutions of higher education
• Independent school districts

Miscellaneous

• Other