Opportunity Information: Apply for PAR 21 083
The NIAID Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required), Funding Opportunity Number PAR-21-083, is a National Institutes of Health (NIH) discretionary funding opportunity from the National Institute of Allergy and Infectious Diseases (NIAID). It uses a cooperative agreement mechanism (U01), which typically means the award is meant to support a well-defined clinical trial project while also involving substantial scientific or programmatic interaction with NIAID staff during the life of the award. The FOA is aimed at moving beyond planning and into actual trial implementation, with a particular emphasis on investigator-initiated clinical trials that are considered high-risk, along with mechanistic studies that are closely tied to those trials.
A central goal of this announcement is to support clinical trials that are ambitious or uncertain enough that they may not fit easily into more conventional funding paths, while still having the potential to generate important clinical and scientific payoffs. The FOA highlights mechanistic research as a major value-add: integrating mechanistic studies into a clinical trial can help explain why an intervention works or does not work, identify biological pathways involved in disease or treatment response, discover biomarkers, and generate insights that inform future therapeutic development. In practice, this means applicants are encouraged to embed or tightly coordinate laboratory, immunologic, genomic, microbiologic, or other translational investigations with the clinical endpoints of the trial, so the study produces not only efficacy and safety findings but also deeper understanding of human disease processes and treatment mechanisms.
The opportunity is aligned with NIAIDs mission space, and applicants are explicitly encouraged to review NIAIDs research priorities and high-priority scientific areas on the institute website. While the text provided does not list specific topic areas, the intent is that proposed trials and associated mechanistic work should clearly fit within NIAIDs overall role and portfolio, which broadly covers allergy, immunology, and infectious diseases, as well as related countermeasure development and clinical research needs within that scope.
A key structural constraint is that only one clinical trial may be proposed per U01 application under this FOA. That means an application should be built around a single, clearly defined trial, rather than a bundle of multiple trials. Mechanistic components are encouraged, but they are expected to be associated with that one clinical trial rather than representing separate standalone clinical studies. This one-trial-per-application rule shapes how applicants should frame their aims, budgets, timelines, and operational plans, focusing on a single trial with well-integrated mechanistic objectives where appropriate.
From an eligibility standpoint, the provided source data indicates eligible applicants include small businesses. The activity category is Health and the CFDA number listed is 93.855, which corresponds to NIAID-related assistance programs. The original closing date shown is 2024-01-13, and the FOA record creation date is 2021-01-14. Award ceiling and expected award counts are not specified in the supplied data, so applicants would need to rely on the full FOA and any NIH/NIAID guidance for budget expectations and likely award volume.
Overall, PAR-21-083 is designed for teams ready to run an investigator-driven clinical trial that carries meaningful scientific risk but also the potential for major impact, especially when paired with mechanistic studies that can clarify biological effects and accelerate future therapeutic strategies. The cooperative agreement format signals that NIAID expects to be actively engaged with awardees to help steer successful execution, which can be particularly important for complex or higher-risk trial implementations.Apply for PAR 21 083
- 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 2021-01-14.
- Applicants must submit their applications by 2024-01-13. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Small businesses.
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FAQs: NIAID Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required) - PAR-21-083
What is the funding opportunity called and who is offering it?
The opportunity is the NIAID Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required) under Funding Opportunity Number (FON) PAR-21-083. It is a National Institutes of Health (NIH) discretionary funding opportunity offered by the National Institute of Allergy and Infectious Diseases (NIAID).
What type of award mechanism is this?
This FOA uses a cooperative agreement mechanism (U01). A U01 generally supports a well-defined clinical trial project and involves substantial scientific or programmatic interaction with NIAID staff during the award period.
Does this opportunity require a clinical trial?
Yes. The FOA is explicitly described as "U01 Clinical Trial Required," and it is focused on clinical trial implementation rather than planning-only activities.
What is the main purpose of PAR-21-083?
The central purpose is to support investigator-initiated clinical trials that are ready to move beyond planning and into implementation. The FOA places particular emphasis on trials that are considered high-risk and on mechanistic studies that are closely tied to those trials.
What does "implementation" mean in the context of this FOA?
Based on the description provided, "implementation" means the work is oriented toward actually conducting the clinical trial (not merely designing or planning it). Applications should be structured around executing a specific, well-defined trial.
What kinds of clinical trials is NIAID trying to support through this announcement?
The FOA is aimed at ambitious, investigator-initiated clinical trials that may be high-risk or uncertain and may not fit easily into more conventional funding paths, but that still have the potential to generate important clinical and scientific payoffs.
What does "high-risk" mean here?
The provided information characterizes "high-risk" as trials that are ambitious or uncertain enough that they may not fit well into conventional funding mechanisms, while still offering the potential for major impact if successful.
Are mechanistic studies required or just encouraged?
Mechanistic studies are strongly emphasized and described as a major value-add. The information provided states they are encouraged and should be closely tied to the clinical trial, but it does not state they are strictly required for every application.
What are mechanistic studies in this context?
Mechanistic studies are translational or biological investigations integrated into (or tightly coordinated with) the clinical trial to help explain how and why an intervention works or does not work. Examples mentioned include laboratory, immunologic, genomic, microbiologic, or other translational investigations that complement the trial's clinical endpoints.
Why does NIAID emphasize embedding mechanistic research into trials?
The FOA highlights that mechanistic research can help explain intervention effects, identify biological pathways, discover biomarkers, and generate insights that inform future therapeutic development. The goal is for the trial to produce safety and efficacy findings as well as deeper understanding of human disease processes and treatment mechanisms.
How should mechanistic work relate to the clinical endpoints?
The expectation described is that mechanistic components should be integrated with, or tightly coordinated to, the clinical endpoints of the trial so that mechanistic objectives complement and enhance the clinical findings rather than function as disconnected activities.
How many clinical trials can be included in one application?
Only one clinical trial may be proposed per U01 application under this FOA. The application should be built around a single, clearly defined trial rather than multiple trials bundled together.
Can the application include multiple mechanistic projects?
The information provided encourages mechanistic components, but they are expected to be associated with the single proposed clinical trial. The description does not authorize separate standalone clinical studies alongside the main trial.
What scientific areas should the proposed trial fit within?
The opportunity is aligned with NIAID's mission space. The description advises applicants to review NIAID research priorities and high-priority scientific areas on the institute website. While specific topic areas are not listed in the provided text, proposals should clearly fit within NIAID's portfolio, broadly covering allergy, immunology, and infectious diseases and related countermeasure development and clinical research needs.
Is this opportunity limited to specific diseases or interventions?
The provided information does not list specific diseases, pathogens, or intervention types. It states that the trial and associated mechanistic work should clearly align with NIAID's mission and priorities.
Who is eligible to apply based on the information provided?
The supplied source data indicates that eligible applicants include small businesses.
What is the activity category for this opportunity?
The activity category is listed as Health.
What is the CFDA number associated with this FOA?
The CFDA number provided is 93.855, which corresponds to NIAID-related assistance programs.
What are the key dates included in the information provided?
The FOA record creation date shown is 2021-01-14. The original closing date shown is 2024-01-13.
Are award amounts or the number of awards specified?
No. The award ceiling and the expected number of awards are not specified in the supplied data. The description notes that applicants would need to rely on the full FOA and any NIH/NIAID guidance for budget expectations and likely award volume.
What does NIAID involvement look like under a cooperative agreement (U01)?
The description indicates that the cooperative agreement format typically includes substantial scientific or programmatic interaction with NIAID staff during the life of the award, reflecting NIAID's active engagement to support successful execution, particularly for complex or higher-risk trial implementations.
Is this FOA intended for planning a trial or running a trial?
This FOA is intended to move beyond planning and into actual trial implementation.
What kind of research outputs does this FOA aim to generate?
It aims to generate clinical outcomes such as efficacy and safety findings, and also deeper biological insights through mechanistic work, such as understanding pathways of disease or treatment response and identifying potential biomarkers that could inform future therapeutic development.
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