Development of Sample Sparing Assays for Monitoring Immune Responses (U24 Clinical Trial Not Allowed) | RFA AI 19 017

Opportunity Information: Apply for RFA AI 19 017

The National Institutes of Health (NIH) announced this discretionary funding opportunity, RFA-AI-19-017, titled "Development of Sample Sparing Assays for Monitoring Immune Responses (U24 Clinical Trial Not Allowed)." It uses a cooperative agreement mechanism (U24), which means awardees should expect substantial scientific and/or programmatic involvement from NIH staff during the project. The overall goal is to speed up the development and validation of new immune-monitoring assays that require less human specimen material while still producing high-quality, information-rich data. In practice, the FOA is aimed at enabling researchers to get more usable immune system readouts from limited human-derived samples, which is often a major constraint in clinical and translational immunology.

The scientific purpose centers on "sample sparing" approaches for studying the human immune system in both health and disease. The FOA emphasizes two main paths to achieving this: (1) meaningfully reducing the volume or amount of specimen needed for any given measurement, and/or (2) enabling simultaneous multi-parameter assessments so that more immune features can be measured at once from the same small sample. This could include assay concepts that consolidate multiple immune function metrics into a single workflow, improve sensitivity so less input material is required, or otherwise increase the efficiency of immune profiling when specimens are scarce, precious, or difficult to obtain. The intent is that these cutting-edge assays will maximize the value of human specimens by reducing sample consumption while maintaining or improving the ability to monitor immune responses.

Because this is labeled "Clinical Trial Not Allowed," applications should not propose clinical trials under NIH definitions. The work is instead oriented toward assay development, optimization, analytical validation, and related preclinical or translational laboratory activities that do not constitute a clinical trial. The end result NIH is pushing for is a set of robust, validated, sample-efficient tools that can be applied broadly to immune monitoring, rather than an interventional study evaluating clinical outcomes.

Eligibility is broad and includes many domestic organization types: state, county, city/township, and 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 other than federally recognized tribal governments; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (outside of higher education); for-profit organizations (other than small businesses) as well as small businesses; and other eligible entities. The FOA explicitly calls out additional eligible applicants 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 government agencies, regional organizations, tribal governments other than federally recognized ones, and U.S. territories or possessions.

Foreign eligibility is restricted. Non-domestic (non-U.S.) entities, including foreign organizations and foreign institutions, are not eligible to apply as the applicant organization. In addition, non-domestic components of U.S. organizations are not eligible to apply. However, the FOA allows "foreign components" as defined in the NIH Grants Policy Statement, meaning a U.S.-based applicant may include certain foreign activities or collaborations when they meet NIH policy requirements and are justified scientifically.

Administrative details provided in the source include an original closing date of July 30, 2019, and a creation date of March 27, 2019. The sponsoring agency is NIH, the activity category is Health, and the CFDA number listed is 93.855. The listing does not provide an award ceiling or expected number of awards in the excerpt shown, so applicants would normally need to consult the full FOA text for budget expectations, project period, review criteria, and specific required components for assay development and validation plans.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Development of Sample Sparing Assays for Monitoring Immune Responses (U24 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 2019-03-27.
• Applicants must submit their applications by 2019-07-30. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• 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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