Opportunity Information: Apply for PAR 27 064
The NIAID Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required), Funding Opportunity Number PAR-27-064, is an NIH discretionary funding opportunity designed to support investigator-initiated clinical trials that are ready for implementation and would benefit from a cooperative agreement structure with enhanced federal involvement and oversight. The emphasis is on milestone-driven trials, meaning applicants are expected to lay out clear, measurable progress points and decision criteria that guide trial execution and allow for close monitoring of performance, timelines, and feasibility as the study advances. This mechanism is aimed at studies where the additional coordination and oversight associated with a U01 is appropriate, rather than a more standard grant mechanism.
A major feature of this NOFO is its encouragement of mechanistic studies when they are applicable to the clinical trial being proposed. In this context, mechanistic work generally refers to analyses that help explain how an intervention works, why it succeeds or fails, and what biological or immunological pathways are involved. NIAID is signaling that these embedded or linked studies can add significant value by improving understanding of human disease processes and generating insights that can inform next-generation treatments, vaccines, diagnostics, or other therapeutic approaches. The mechanistic component is not presented as universally required for every application, but it is highlighted as an important opportunity to increase the scientific yield of a clinical trial when scientifically justified.
The award supports implementation of a single clinical trial per application, which is an important constraint for planning and proposal design. Applicants cannot bundle multiple independent trials into one U01 submission under this NOFO; instead, the expectation is one clearly defined protocol with its associated operational plan, oversight structure, recruitment and retention approach, data management, safety monitoring, and, if relevant, mechanistic sub-studies. Because this is a clinical trial required announcement, proposed projects must meet NIH’s definition of a clinical trial and must be structured accordingly, including the operational and regulatory elements needed to start and run the trial.
In terms of project period, NIAID indicates it will support clinical trials up to 5 years in duration, with an option for extended trials lasting 6 or 7 years when warranted. This is useful for studies that require longer follow-up, extended enrollment windows, or outcomes that take more time to accrue. While the summary information provided does not list a specific award ceiling or the expected number of awards, the cooperative agreement format typically implies active programmatic engagement from NIH staff, particularly around milestones, monitoring, and any needed course corrections to keep the trial on track.
Applications will go through standard NIH peer review, and only those judged to be scientifically and technically strong will be considered for funding. The NOFO references Section III (Eligibility Information) for full eligibility rules, but the provided eligibility list is broad and includes many common applicant types: state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; nonprofit organizations with or without 501(c)(3) status (excluding higher education institutions in those categories); for-profit organizations other than small businesses; small businesses; and other eligible entities, including certain Native American tribal governments and tribal organizations, and public housing authorities/Indian housing authorities.
International participation is explicitly allowed and relatively flexible. Non-U.S. entities (foreign organizations) are eligible to apply directly. In addition, non-U.S. components of U.S. organizations may participate, and foreign components (as defined in the NIH Grants Policy Statement) are allowed. This makes the opportunity workable for multinational trials, trials conducted in non-U.S. settings, or U.S.-led studies that require overseas sites, populations, or laboratory collaborations.
Administratively, the sponsoring agency is the National Institutes of Health, and the activity category is Health under CFDA 93.855. The opportunity was created on 2026-06-16, and the original closing date is listed as 2029-07-05, suggesting a multi-year window during which NIH intends to accept applications, likely through multiple receipt dates outlined in the full NOFO. Applicants are also encouraged to consult NIAID’s mission and research areas to ensure alignment, since fit with institute priorities is typically a key factor in both responsiveness and ultimate funding decisions under NIH programs.Apply for PAR 27 064
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NIAID Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.855.
- This funding opportunity was created on 2026-06-16.
- Applicants must submit their applications by 2029-07-05.
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than 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, For-profit organizations other than small businesses, Small businesses, Others.
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FAQs: NIAID Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required) - PAR-27-064
What is the name of this funding opportunity?
The opportunity is the NIAID Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required), Funding Opportunity Number (FON) PAR-27-064.
Who is the sponsoring agency?
The sponsoring agency is the National Institutes of Health (NIH), through the National Institute of Allergy and Infectious Diseases (NIAID).
What type of funding mechanism is this?
This is a cooperative agreement (U01). A cooperative agreement is used when there is expected to be enhanced federal involvement in the supported project, including coordination and oversight.
Is this opportunity for clinical trials only?
Yes. This is labeled "Clinical Trial Required," which means the proposed project must meet the NIH definition of a clinical trial and must be structured as a clinical trial application, including the operational and regulatory elements needed to start and run the study.
What is the primary purpose of this U01 opportunity?
It is designed to support investigator-initiated clinical trials that are ready for implementation and would benefit from a cooperative agreement structure with enhanced NIH involvement and oversight.
What does "ready for implementation" imply in this announcement?
Based on the description provided, the emphasis is on trials that can move into execution with a clear operational plan, defined oversight, and the ability to measure progress against predefined milestones as the study advances.
What does "milestone-driven" mean for applicants?
Applicants are expected to propose clear and measurable milestones (progress points) and decision criteria. These milestones are meant to guide trial execution and allow close monitoring of performance, timelines, and feasibility, with the ability to assess whether the trial is staying on track.
Why would an investigator choose a U01 cooperative agreement instead of a standard grant mechanism?
This mechanism is intended for situations where the added coordination and oversight associated with a U01 is appropriate. The summary emphasizes enhanced federal involvement, especially around milestones, monitoring, and course corrections to keep the trial on track.
How many clinical trials can be included in one application?
One. The award supports implementation of a single clinical trial per application, and applicants cannot bundle multiple independent trials into one submission under this NOFO.
What needs to be included conceptually when proposing the single trial?
The summary indicates the expectation is one clearly defined protocol with its associated operational plan, oversight structure, recruitment and retention approach, data management, safety monitoring, and, if relevant, mechanistic sub-studies.
Are mechanistic studies required?
No. Mechanistic studies are encouraged when applicable, but they are not presented as universally required for every application.
What are "mechanistic studies" in the context of this NOFO?
Mechanistic studies generally refer to analyses that help explain how an intervention works, why it succeeds or fails, and which biological or immunological pathways are involved. The goal is to increase the scientific yield of the clinical trial when scientifically justified.
Why is NIAID encouraging mechanistic studies alongside clinical trials?
The summary notes that embedded or linked mechanistic work can improve understanding of human disease processes and generate insights that may inform next-generation treatments, vaccines, diagnostics, or other therapeutic approaches.
What is the maximum project period supported?
NIAID indicates it will support clinical trials up to 5 years in duration, with an option for extended trials lasting 6 or 7 years when warranted.
When would a 6- or 7-year trial be appropriate under this opportunity?
The summary suggests extensions may be warranted for studies that require longer follow-up, extended enrollment windows, or outcomes that take more time to accrue.
Is there an award ceiling or a stated number of awards?
Not in the summary provided. The information given does not list a specific award ceiling or the expected number of awards.
How are applications reviewed?
Applications will go through standard NIH peer review, and only those judged to be scientifically and technically strong will be considered for funding.
Who is eligible to apply?
The summary describes broad eligibility and points to Section III (Eligibility Information) in the full NOFO for complete rules. The listed eligible applicant types include:
- State governments
- County governments
- City or township governments
- Special district governments
- Independent school districts
- Public and state-controlled institutions of higher education
- Private institutions of higher education
- Nonprofit organizations with or without 501(c)(3) status (excluding higher education institutions in those categories)
- For-profit organizations other than small businesses
- Small businesses
- Other eligible entities, including certain Native American tribal governments and tribal organizations
- Public housing authorities/Indian housing authorities
Are foreign (non-U.S.) organizations eligible to apply directly?
Yes. Non-U.S. entities (foreign organizations) are explicitly eligible to apply directly.
Can U.S. organizations include foreign components or overseas sites?
Yes. The summary states that non-U.S. components of U.S. organizations may participate, and foreign components (as defined in the NIH Grants Policy Statement) are allowed.
Does this opportunity support multinational or non-U.S.-based trials?
Yes. Because foreign organizations can apply and foreign components are allowed, the opportunity is workable for multinational trials, trials conducted in non-U.S. settings, or U.S.-led studies that require overseas sites, populations, or laboratory collaborations.
What is the activity category and CFDA number?
The activity category is Health, and the CFDA listing is 93.855.
When was this opportunity created?
The opportunity was created on 2026-06-16.
What is the listed closing date?
The original closing date is listed as 2029-07-05, suggesting a multi-year window during which NIH intends to accept applications (likely through multiple receipt dates in the full NOFO).
Does NIAID alignment matter for this NOFO?
Yes. Applicants are encouraged to consult NIAID's mission and research areas to ensure alignment, since fit with institute priorities is typically a key factor in responsiveness and funding decisions under NIH programs.
What level of NIH involvement should applicants expect during the project?
While details are not provided in the summary, it notes that the cooperative agreement format typically implies active programmatic engagement from NIH staff, particularly around milestones, monitoring, and potential course corrections to keep the trial on track.
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