Opportunity Information: Apply for PAR 18 632
The NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44 Clinical Trial Required), Funding Opportunity Number PAR-18-632, is a National Institutes of Health funding opportunity designed specifically for U.S. small business concerns that are ready to carry out an investigator-initiated clinical trial that aligns with the National Institute of Allergy and Infectious Diseases (NIAID) research mission. It uses the SBIR Phase II mechanism and is awarded as a cooperative agreement, meaning the project is supported like a grant but with substantial involvement from NIAID staff during planning, oversight, and execution. The intent is to help small businesses move beyond early feasibility and into real-world clinical testing in a structured, accountable way that supports product and evidence development.
The program emphasizes clinical trials that are hypothesis-driven and milestone-driven. In practice, that means applicants are expected to clearly state the scientific or clinical hypothesis the trial is meant to test and to lay out measurable milestones that will be used to track progress and guide continued support. While standard or lower-risk clinical trials can be proposed, NIAID explicitly encourages studies considered "high-risk" from a clinical research operations standpoint. Here, "high-risk" is not about exposing participants to higher danger; it refers to trials that are more complex or novel in execution, such as using non-routine interventions, administering an unlicensed product, or testing a licensed product for an unapproved indication. The goal is to encourage innovation in clinical evaluation where the path may be less straightforward but the potential scientific or public health payoff is meaningful.
The FOA also encourages mechanistic studies, meaning the trial can include components that help explain how an intervention works biologically or immunologically, not just whether it works. That can be important for infectious disease and immunology-related products where understanding mechanism can support later-stage development, refinement of dosing or schedules, identification of biomarkers, or selection of populations most likely to benefit. Even with that flexibility, the application is expected to focus on a single clinical trial; the opportunity does not allow applicants to bundle multiple distinct clinical trials into one submission.
NIAID highlights that it already maintains a strong ecosystem for conducting clinical studies, including resources supported through grants, cooperative agreements, and contracts, as well as capabilities embedded in established NIAID-supported clinical trial networks. Applicants may propose to use NIAID's independent clinical study infrastructure, but the FOA draws a clear boundary: funds will not be provided for trials that rely on dedicated resources that are part of a NIAID-supported clinical trial network. In other words, a small business can potentially leverage certain NIAID-related infrastructure, but it cannot propose a study that depends on reserved network resources in a way that would effectively treat the network as the funded trial platform.
Eligibility is limited to small businesses, consistent with SBIR rules. Foreign entities (non-U.S. institutions) are not eligible to apply, and non-domestic components of U.S. organizations are also not eligible. However, foreign components as defined under the NIH Grants Policy Statement may be allowed, which typically means discrete parts of the project may occur outside the U.S. if they are well-justified and meet NIH policy requirements, but the applicant organization must be a U.S. small business and the overall project structure must comply with the stated restrictions.
Administratively, this is a discretionary funding opportunity in the health category under CFDA 93.855. The FOA was created on 2018-02-06, and the original closing date listed is 2021-01-13. The source information provided does not specify an award ceiling or expected number of awards, so prospective applicants would normally confirm current budget limits, program priorities, and any updated submission dates or reissuances by checking the live NIH notice and related guide announcements. Overall, the opportunity is aimed at helping small businesses implement one well-defined, clinically meaningful, milestone-based trial in areas relevant to NIAID, with a particular interest in ambitious or operationally novel clinical studies and the option to incorporate mechanistic research to strengthen the scientific value of the results.Apply for PAR 18 632
- 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 2018-02-06.
- Applicants must submit their applications by 2021-01-13. (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 SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44 Clinical Trial Required) - PAR-18-632
What is this funding opportunity?
This is an NIH funding opportunity from the National Institute of Allergy and Infectious Diseases (NIAID) that supports U.S. small business concerns that are ready to implement an investigator-initiated clinical trial aligned with the NIAID research mission. It uses the SBIR Phase II mechanism and is specifically for carrying out a clinical trial (clinical trial required).
What is the Funding Opportunity Number (FOA number)?
The Funding Opportunity Number is PAR-18-632.
What funding mechanism is used?
It uses the SBIR Phase II mechanism and is awarded as a cooperative agreement (U44).
What does "cooperative agreement" mean in this context?
A cooperative agreement is supported like a grant, but it includes substantial involvement from NIAID staff during planning, oversight, and execution of the project. The involvement is part of how the award is managed and monitored.
Who is eligible to apply?
Eligibility is limited to U.S. small business concerns, consistent with SBIR rules.
Are foreign organizations eligible to apply?
No. Foreign entities (non-U.S. institutions) are not eligible to apply.
Are non-domestic components of U.S. organizations eligible?
No. Non-domestic components of U.S. organizations are also not eligible under this opportunity.
Are any foreign components allowed at all?
Potentially, yes. Foreign components (as defined under the NIH Grants Policy Statement) may be allowed if they are discrete parts of the project, are well-justified, and meet NIH policy requirements. The applicant organization must still be a U.S. small business, and the overall project must comply with the stated restrictions.
What type of project is NIAID looking to fund?
The program is intended to help small businesses move beyond early feasibility and into real-world clinical testing. It supports one well-defined, clinically meaningful, investigator-initiated clinical trial that fits within the NIAID mission and is run in a structured, accountable way.
Is a clinical trial required under this FOA?
Yes. This is described as a "Clinical Trial Implementation" opportunity and explicitly indicates "Clinical Trial Required."
Does the application need to be hypothesis-driven?
Yes. NIAID emphasizes hypothesis-driven clinical trials, meaning the application is expected to clearly state the scientific or clinical hypothesis the trial will test.
Does the application need to be milestone-driven?
Yes. Applicants are expected to propose measurable milestones that will be used to track progress and guide continued support.
What does NIAID mean by encouraging "high-risk" studies?
"High-risk" here refers to clinical research operations risk (complexity or novelty of execution), not higher risk to participant safety. Examples include trials that use non-routine interventions, administer an unlicensed product, or test a licensed product for an unapproved indication.
Are standard or lower-risk clinical trials allowed?
Yes. Standard or lower-risk clinical trials can be proposed, even though NIAID encourages operationally complex or novel studies.
Can the trial include mechanistic studies?
Yes. The FOA encourages mechanistic studies that help explain how an intervention works biologically or immunologically, not only whether it works. These components can strengthen product and evidence development.
Why might mechanistic studies be important for this program?
Mechanistic work can help interpret clinical results and support later-stage development, including refinement of dosing or schedules, identification of biomarkers, and selection of populations most likely to benefit.
Can an application propose more than one clinical trial?
No. The application is expected to focus on a single clinical trial. The opportunity does not allow bundling multiple distinct clinical trials into one submission.
Can applicants use NIAID clinical study infrastructure?
Applicants may propose to use NIAID's independent clinical study infrastructure. NIAID notes it has an ecosystem of resources supported through grants, cooperative agreements, and contracts, along with capabilities in established NIAID-supported clinical trial networks.
Are there restrictions related to NIAID-supported clinical trial networks?
Yes. Funds will not be provided for trials that rely on dedicated resources that are part of a NIAID-supported clinical trial network. In other words, the project cannot depend on reserved network resources in a way that effectively makes the network the funded trial platform.
What is the intent of the program overall?
The intent is to help small businesses implement a structured, accountable Phase II clinical trial with clear hypotheses and milestones, supported through a cooperative agreement with substantial NIAID involvement, to advance clinically meaningful evaluation aligned with NIAID's mission.
What is the CFDA number and category for this opportunity?
It is listed as a discretionary funding opportunity in the health category under CFDA 93.855.
When was the FOA created and what is the closing date listed in the source information?
The FOA was created on 2018-02-06, and the original closing date listed is 2021-01-13.
Does the provided information include an award ceiling or expected number of awards?
No. The source information provided does not specify an award ceiling or the expected number of awards.
What should applicants do about budget limits, current priorities, or updated dates?
Since the provided information does not include budget caps, expected awards, or any updates beyond the original closing date, prospective applicants would typically confirm current budget limits, program priorities, and any updated submission dates or reissuances by checking the live NIH notice and related guide announcements.
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