NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44 Clinical Trial Required) | PAR 18 632

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.

• 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.

Apply for PAR 18 632

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