Opportunity Information: Apply for PAR 24 099
The NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44 Clinical Trial Required), Funding Opportunity Number PAR-24-099, is a National Institutes of Health discretionary funding program designed to help U.S. small business concerns move into the actual implementation of an investigator-initiated clinical trial that aligns with the research mission of the National Institute of Allergy and Infectious Diseases (NIAID). It uses a cooperative agreement mechanism (U44), which generally means the project will be carried out with substantial NIH/NIAID involvement compared with a traditional grant, reflecting the hands-on nature of running a clinical trial and the need for close coordination around trial conduct, milestones, and oversight.
At its core, the opportunity is aimed at hypothesis-driven clinical trials that are also milestone-driven, meaning applicants should be prepared to define clear, measurable objectives and go/no-go decision points that show whether the study is progressing as planned. The NOFO supports clinical trial implementation rather than purely planning or exploratory work, and it emphasizes disciplined execution: strong rationale, well-defined endpoints, operational readiness, and a trial design that can generate interpretable results tied to the stated hypothesis. In addition to the main clinical outcomes, the program also welcomes mechanistic studies, which can be included to help explain how an intervention works, identify biological correlates, or clarify pathways that relate to efficacy, safety, or immune responses, as long as they are appropriately integrated with the clinical trial.
A notable feature of this NOFO is its explicit encouragement of higher-risk clinical studies, but with an important clarification about what "high-risk" means in this context. It is not referring to elevated risk to human participants; instead, it refers to scientific or operational novelty and uncertainty. Examples include studies that involve non-routine interventions, administration of an unlicensed product, or use of a licensed product for an unapproved indication. In other words, NIAID is signaling interest in trials that may carry greater development or translation uncertainty because they test something new, unconventional, or not yet established in the intended clinical setting, while still requiring appropriate participant protections and regulatory compliance.
Eligibility is limited to small businesses, consistent with the SBIR program’s purpose of supporting innovation and commercialization-oriented R&D within U.S. small business concerns. Foreign organizations (non-U.S. entities) are not eligible to apply, and non-domestic components of U.S. organizations are also not eligible to apply as part of the project. However, foreign components as defined by the NIH Grants Policy Statement may be allowed in some circumstances, which typically means that certain limited, well-justified activities could be performed outside the U.S. if they are necessary for the project and meet NIH policy requirements.
Key administrative details provided include the sponsoring agency (National Institutes of Health), the health-related activity category, and the CFDA number 93.855. The opportunity was created on January 29, 2024, and lists an original closing date of January 13, 2027. While the provided source text does not specify an award ceiling or expected number of awards, the central takeaway is that this is a Phase II SBIR pathway specifically focused on executing a clinical trial under a cooperative agreement structure, with strong emphasis on milestone-based progress and openness to scientifically bold trial concepts that fit within NIAID’s mission areas.Apply for PAR 24 099
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44 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 2024-01-29.
- Applicants must submit their applications by 2027-01-13.
- Eligible applicants include: Small businesses.
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FAQs: NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44 Clinical Trial Required) - PAR-24-099
What is this funding opportunity?
This opportunity is the NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44 Clinical Trial Required), Funding Opportunity Number PAR-24-099. It is a discretionary funding program from the National Institutes of Health (NIH), specifically the National Institute of Allergy and Infectious Diseases (NIAID), intended to support U.S. small businesses conducting the actual implementation of an investigator-initiated clinical trial that aligns with NIAID's research mission.
Which NIH institute is sponsoring this opportunity?
The sponsoring agency is the National Institutes of Health (NIH), and the specific institute tied to this program is the National Institute of Allergy and Infectious Diseases (NIAID).
What does "SBIR Phase II" mean in this context?
Based on the information provided, this is an SBIR Phase II pathway aimed at U.S. small business concerns. The emphasis is on moving into clinical trial implementation (executing the clinical trial), rather than doing only preliminary or exploratory work.
What funding mechanism is used (and what does U44 mean)?
The mechanism is a cooperative agreement (U44). A cooperative agreement generally indicates substantial NIH/NIAID involvement compared with a traditional grant. In practice, this reflects the hands-on nature of implementing a clinical trial and the need for close coordination around trial conduct, milestones, and oversight.
Is a clinical trial required under this NOFO?
Yes. The opportunity is explicitly framed as a "Clinical Trial Required" program and is focused on clinical trial implementation.
What types of clinical trials does this NOFO support?
The NOFO supports hypothesis-driven clinical trials that are also milestone-driven. Applicants should be prepared to propose a trial design with a strong scientific rationale, well-defined endpoints, operational readiness, and an approach capable of generating interpretable results tied to the stated hypothesis.
Does this funding support clinical trial planning only?
No. The emphasis is on clinical trial implementation rather than purely planning or exploratory work. The program description focuses on disciplined execution and readiness to conduct the trial.
What does "milestone-driven" mean for applicants?
"Milestone-driven" means applicants should define clear, measurable objectives and include go/no-go decision points to demonstrate whether the study is progressing as planned. This frames the project around concrete progress markers and decision-making checkpoints.
Are mechanistic studies allowed as part of the project?
Yes. Mechanistic studies are welcomed if they are appropriately integrated with the clinical trial. These studies can help explain how an intervention works, identify biological correlates, or clarify pathways related to efficacy, safety, or immune responses.
What does the NOFO mean by encouraging "higher-risk" studies?
In this context, "high-risk" refers to scientific or operational novelty and uncertainty, not increased risk to human participants. NIAID is signaling interest in trials that may have greater development or translation uncertainty because they test something new or unconventional in the intended clinical setting.
Does "higher-risk" mean participants can be exposed to greater danger?
No. The description clarifies that "high-risk" is not about elevated risk to human participants. Participant protections and regulatory compliance are still required.
What are examples of "high-risk" trials as described here?
Examples provided include studies involving non-routine interventions, administration of an unlicensed product, or use of a licensed product for an unapproved indication.
Who is eligible to apply?
Eligibility is limited to small businesses, consistent with the SBIR program's purpose of supporting innovation and commercialization-oriented R&D within U.S. small business concerns.
Can foreign organizations apply?
No. Foreign organizations (non-U.S. entities) are not eligible to apply.
Can a U.S. applicant include non-domestic components as part of the project?
No. Non-domestic components of U.S. organizations are not eligible to apply as part of the project.
Are any foreign activities allowed at all?
Possibly. The description notes that foreign components, as defined by the NIH Grants Policy Statement, may be allowed in some circumstances. This typically means limited, well-justified activities performed outside the U.S. may be permitted if they are necessary for the project and meet NIH policy requirements.
What is the main purpose of the program?
The central purpose is to help U.S. small business concerns move into the actual implementation of an investigator-initiated clinical trial aligned with NIAID's mission, using a cooperative agreement structure with strong emphasis on milestone-based progress and appropriate oversight.
What kind of results is NIAID looking for from supported trials?
The program emphasizes trials designed to produce interpretable results tied to the stated hypothesis, with well-defined endpoints and disciplined execution. Mechanistic data may also be included when integrated appropriately.
How involved will NIH/NIAID be during the project?
Because this is a U44 cooperative agreement, the project is expected to involve substantial NIH/NIAID involvement compared with a traditional grant, reflecting close coordination needs for trial conduct, milestones, and oversight.
What is the Funding Opportunity Number for this program?
The Funding Opportunity Number is PAR-24-099.
What is the CFDA number associated with this opportunity?
The CFDA number provided is 93.855.
When was this opportunity created?
The opportunity was created on January 29, 2024.
What is the closing date listed for this opportunity?
The original closing date listed is January 13, 2027.
Does the provided information state an award ceiling or number of awards?
No. The provided source text does not specify an award ceiling or the expected number of awards.
What is the key takeaway for applicants deciding whether this fits?
This is a Phase II SBIR pathway focused on executing a clinical trial (not just planning), under a cooperative agreement (U44) with substantial NIH/NIAID involvement, emphasizing milestone-based progress and openness to scientifically bold trial concepts that fit within NIAID mission areas.
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