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National Institutes of Health · United States

Early to Definitive Clinical Trials (R61/R33 Clinical Trial Required)

Forecast — expected to open 31 May 2027

This is a forecast: the funder has announced the opportunity but it is not open yet; posting is expected around 31 May 2027 and the estimated deadline is 31 Jul 2027. Eligible applicant types include nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, city or township governments, for profit organizations other than small businesses and 12 more.

About this call

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.

Who can apply

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

Applicant categories are a starting point. The official call decides eligibility.

Topics

Health

How to apply

1. Read the full notice of funding opportunity (NOFO) linked from the official page: eligibility, cost sharing and evaluation criteria.
2. Make sure your organisation has an active SAM.gov registration and Unique Entity ID (UEI); registration can take several weeks.
3. For NIH: the organisation and the principal investigator also need eRA Commons accounts; applications are usually submitted through Grants.gov (for example with ASSIST).
4. Prepare the required forms, narrative, budget and attachments exactly as the NOFO specifies.
5. Submit before the deadline and keep the tracking number. Check for amendments before you submit.

From the call text

Who can apply

Not stated in the call text we hold — check the official page

Company stage

Not stated in the call text we hold — check the official page

Single applicant or consortium

Not stated in the call text we hold — check the official page

Where applicants must be based

Not stated in the call text we hold — check the official page

Where to apply

Not stated in the call text we hold — check the official page

Contact

NIA Scientific Program Contact · NIA-NOFO-Scientific@nih.gov · Please contact via e-mail

Where these facts come from

Official sources

Official call page

Facts on this page come from the funder’s official data, taken on 15 Nov 2026. The funder's own documents, including later amendments, always take precedence.

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