Opportunity Information: Apply for PAR 13 250
Apply for PAR 13 250
- 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)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.855 Allergy and Infectious Diseases Research 93.856 Microbiology and Infectious Diseases Research.
- This funding opportunity was created on Jun 24, 2013 and posted on Jun 24, 2013.
- Applicants must submit their applications by May 13, 2016. (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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Opportunity Summary:
The NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44) is a National Institutes of Health funding opportunity designed specifically for eligible small business concerns that are ready to move into implementing an investigator-initiated clinical trial aligned with the research mission of the National Institute of Allergy and Infectious Diseases (NIAID). The focus is on hypothesis-driven clinical studies that are managed against clear, pre-defined milestones, and the award uses a cooperative agreement structure (U44). In practical terms, that means the project is not just funded and left alone; NIAID expects to have substantial involvement during the life of the award, which is typical for cooperative agreements where close coordination, progress monitoring, and milestone-based decision points matter.
A key feature of this opportunity is its encouragement of clinical trials that are considered "high risk" from a development and innovation standpoint. Here, "high risk" is not about putting participants at higher safety risk; it refers to studies that push beyond routine clinical research in ways that can make execution and outcomes more uncertain. Examples include trials involving non-routine interventions, administration of an unlicensed product, or use of an already-licensed product for an unapproved indication. While lower-risk trials can be proposed, the FOA clearly signals interest in bolder studies that could open new scientific or clinical directions in allergy, immunology, and infectious diseases.
The program also welcomes mechanistic studies as part of the clinical trial approach, meaning applicants can propose embedded investigations that help explain how an intervention works, what biological pathways are affected, or which immune or microbial markers correlate with response. This can strengthen the scientific value of a trial by generating data that informs not only whether something works, but why it works and for whom. At the same time, the FOA limits scope by requiring that each application propose no more than one clinical trial, which helps ensure projects remain focused and manageable within Phase II SBIR expectations.
Another important element is how applicants can and cannot use NIAID clinical trial infrastructure. NIAID highlights that it already supports a strong ecosystem for clinical studies through independently managed resources funded by grants and contracts, as well as capabilities housed within established NIAID-supported clinical trial networks. Applicants may leverage NIAID's independent clinical study infrastructure, but the FOA draws a firm boundary: it will not support studies that require dedicated resources that are part of a NIAID-supported clinical trial network. In other words, the proposal should not be built around tapping into a network's dedicated, network-specific operational assets; instead, it should rely on appropriate independent resources and planning that fit the SBIR-supported trial implementation model.
Commercial readiness is treated as a required part of the application, not an afterthought. A Commercialization Plan must be included, describing how the small business will promote further commercialization of the intervention, product, or technology that is derived from or associated with the proposed clinical trial. This plan is expected to go beyond general intentions and address concrete steps for advancing toward market adoption, including how the Phase II awardee will encourage and establish partnerships with third-party investors and/or strategic partners. The intent is to ensure the clinical trial is not isolated from real-world development pathways and that there is a credible strategy for translating trial outcomes into a viable commercial product or platform.
Administratively, this is a discretionary funding opportunity from the National Institutes of Health, using a Cooperative Agreement funding instrument, in the Health activity category. It is tied to CFDA program areas 93.855 (Allergy and Infectious Diseases Research) and 93.856 (Microbiology and Infectious Diseases Research). There is no cost sharing or matching requirement, and eligibility is restricted to small businesses. The opportunity was posted on June 24, 2013, with an original and final closing date of May 13, 2016, and an archive date of June 13, 2016, meaning the specific FOA referenced (PAR 13-250) is historical rather than currently open. The full announcement was hosted through the NIH Grants Guide, and NIH provided standard technical contact support through the NIH Office of Extramural Research webmaster for access or linking issues.
FAQs: NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44)
What is the NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44)?
It is a National Institutes of Health (NIH) funding opportunity from the National Institute of Allergy and Infectious Diseases (NIAID) designed for eligible small business concerns that are ready to implement an investigator-initiated clinical trial aligned with the NIAID research mission. The funding mechanism is a cooperative agreement (U44), meaning NIAID expects substantial involvement during the award.
Is this opportunity a grant or a cooperative agreement, and why does that matter?
This opportunity uses a cooperative agreement structure (U44), not a standard grant. Practically, that means NIAID is expected to have substantial involvement during the life of the award, including close coordination, progress monitoring, and milestone-based decision points.
Who is eligible to apply?
Eligibility is restricted to small businesses (eligible small business concerns). No other eligibility categories are described in the provided information.
What type of clinical trial does this funding opportunity support?
It supports implementation of an investigator-initiated clinical trial that is aligned with NIAID's research mission, with an emphasis on hypothesis-driven clinical studies that are managed against clear, pre-defined milestones.
What research areas are relevant for this opportunity?
The opportunity is aligned with NIAID's mission, and the provided information highlights allergy, immunology, and infectious diseases. It is also tied to CFDA program areas 93.855 (Allergy and Infectious Diseases Research) and 93.856 (Microbiology and Infectious Diseases Research).
Does the FOA encourage "high risk" clinical trials?
Yes. A key feature is encouragement of clinical trials considered "high risk" from a development and innovation standpoint, meaning the trial pushes beyond routine clinical research in ways that can make execution and outcomes more uncertain.
What does "high risk" mean in this FOA?
In this context, "high risk" refers to development and innovation risk, not increased safety risk to participants. The examples provided include trials involving non-routine interventions, administration of an unlicensed product, or use of an already-licensed product for an unapproved indication.
Are lower-risk clinical trials allowed?
Yes. The information indicates that while lower-risk trials can be proposed, the FOA signals particular interest in bolder studies that could open new scientific or clinical directions in allergy, immunology, and infectious diseases.
Can mechanistic studies be included as part of the clinical trial?
Yes. The program welcomes mechanistic studies as part of the clinical trial approach, including embedded investigations intended to help explain how an intervention works, what pathways are affected, or which immune or microbial markers correlate with response.
How many clinical trials can be proposed in a single application?
Each application must propose no more than one clinical trial, which helps keep the project focused and manageable within Phase II SBIR expectations.
What is the expectation around milestones and monitoring?
The FOA emphasizes hypothesis-driven studies managed against clear, pre-defined milestones. Because it is a cooperative agreement, NIAID expects substantial involvement such as progress monitoring and milestone-based decision points during the award.
Can applicants use NIAID clinical trial infrastructure?
Applicants may leverage NIAID's independently managed clinical study infrastructure (resources supported through grants and contracts), as described in the provided information.
Are NIAID-supported clinical trial networks allowed to be used for dedicated network resources?
No. The FOA draws a firm boundary and will not support studies that require dedicated resources that are part of a NIAID-supported clinical trial network. The proposal should not be built around using a network's dedicated, network-specific operational assets.
What is the key distinction between independent NIAID infrastructure and network-dedicated resources?
Based on the provided information, independent infrastructure refers to resources funded through grants and contracts that are independently managed and can be leveraged. Network-dedicated resources refer to operational assets that are specific to NIAID-supported clinical trial networks; the FOA will not support studies requiring those dedicated network resources.
Is a Commercialization Plan required?
Yes. Commercial readiness is treated as a required part of the application. A Commercialization Plan must be included describing how the small business will promote further commercialization of the intervention, product, or technology derived from or associated with the proposed clinical trial.
What must the Commercialization Plan cover?
The plan is expected to go beyond general intentions and include concrete steps for advancing toward market adoption, including how the Phase II awardee will encourage and establish partnerships with third-party investors and/or strategic partners.
Why does this FOA emphasize commercialization?
The stated intent is to ensure the clinical trial is not isolated from real-world development pathways and that there is a credible strategy for translating trial outcomes into a viable commercial product or platform.
Is cost sharing or matching required?
No. The provided information states there is no cost sharing or matching requirement.
Which federal agency and institute sponsor this opportunity?
The opportunity is offered through the National Institutes of Health (NIH) and is specifically associated with the National Institute of Allergy and Infectious Diseases (NIAID).
What is the activity category and funding type?
It is described as a discretionary funding opportunity from NIH, using a Cooperative Agreement funding instrument, in the Health activity category.
What are the key dates for this funding opportunity?
It was posted on June 24, 2013. The original and final closing date was May 13, 2016. The archive date was June 13, 2016.
Is this FOA currently open for applications?
No. The information provided states the FOA referenced (PAR 13-250) is historical rather than currently open, with a final closing date of May 13, 2016 and an archive date of June 13, 2016.
Where was the full announcement posted?
The full announcement was hosted through the NIH Grants Guide.
Who provides technical support for access or linking issues?
NIH provided standard technical contact support through the NIH Office of Extramural Research webmaster for access or linking issues.
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