Development and Optimization of Next-Generation Immunological Assays to Support Influenza Clinical Studies and Trials (UH2/UH3 Clinical Trial Not Allowed) | RFA AI 22 020

Opportunity Information: Apply for RFA AI 22 020

The grant opportunity titled "Development and Optimization of Next-Generation Immunological Assays to Support Influenza Clinical Studies and Trials (UH2/UH3 Clinical Trial Not Allowed)" (Funding Opportunity Number RFA AI 22 020) is a discretionary funding program run by the National Institutes of Health (NIH) under CFDA 93.855. It uses a cooperative agreement mechanism, meaning awardees should expect substantial scientific coordination and involvement from NIH program staff compared to a standard research grant. The core aim is to support collaborative, multidisciplinary teams that can build, refine, and validate newer, better immunological assay approaches specifically tailored to influenza research, with the practical expectation that these assays will be ready to plug into influenza clinical studies and trials by the time the project ends.

Scientifically, the emphasis is on creating and optimizing "next-generation" immunological assays, which generally implies methods that improve on current tools in sensitivity, specificity, throughput, reproducibility, standardization, or their ability to capture more informative immune readouts. While the opportunity description does not list specific assay types, the intent is clearly translational and use-focused: the assays should not just be interesting in a lab setting, but should be mature enough to be adopted in real-world influenza clinical research settings. The notice also makes clear that clinical trials are not allowed under this FOA, which typically means applicants should not propose interventional studies assigning human participants to receive an intervention; instead, the work should center on assay development and optimization that supports trials rather than running a trial itself.

The project structure is based on the UH2/UH3 phased award model. In practice, that usually means an initial exploratory or development phase (UH2) followed by a second phase (UH3) that supports expanded optimization, refinement, and demonstration of readiness for intended use, with progression commonly tied to meeting predefined milestones. The practical message to applicants is that they should lay out a clear pathway from concept to a deliverable assay platform that is robust, standardized, and credible for influenza clinical study use by the end of the overall award period.

Eligibility is broad and includes many categories of U.S. public and private organizations: state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations that are not federally recognized governments; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations (other than small businesses); and small businesses. The announcement also explicitly highlights additional eligible applicant types such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISISs, Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and even non-U.S. entities (foreign organizations). Taken together, this signals NIH interest in drawing from a wide pool of technical expertise and institutional capacity, including organizations that may bring specialized assay platforms, biostatistical rigor, clinical laboratory experience, or access to relevant specimens and influenza research networks.

From a funding and timing standpoint, the opportunity was created on 2022-04-05 and had an original closing date of 2022-07-01. The listed award ceiling is $500,000. The source text shows "ExpectedAwards:" without a number, so the total number of awards is not specified in the provided data. Overall, the program is best understood as targeted support for teams that can produce standardized, next-generation immune measurement tools for influenza, with a strong expectation of real adoption in clinical study environments and with NIH actively involved through the cooperative agreement structure.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Development and Optimization of Next-Generation Immunological Assays to Support Influenza Clinical Studies and Trials (UH2/UH3 Clinical Trial Not Allowed)" 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 2022-04-05.
• Applicants must submit their applications by 2022-07-01. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $500,000.00 in funding.
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

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