Exploring the Scientific Value of Existing or New Sepsis Human Biospecimen Collections (R21/R33 - Clinical Trial Not Allowed) | PAR 21 077

Opportunity Information: Apply for PAR 21 077

Exploring the Scientific Value of Existing or New Sepsis Human Biospecimen Collections (R21/R33 - Clinical Trial Not Allowed) is a National Institutes of Health (NIH) discretionary grant opportunity (PAR-21-077; CFDA 93.859) focused on improving how human biospecimens and related clinical information from critically ill patients are collected, stored, shared, and ultimately used to drive mechanistic discoveries in sepsis. The core intent is not to fund a clinical trial or test an intervention in patients, but to build and evaluate high-quality human sepsis biospecimen resources that can serve as reliable "testbeds" for research into the biology of sepsis, including why patients differ so dramatically in immune responses, organ dysfunction, trajectories, and outcomes.

A central theme of the announcement is efficiency and usefulness to the broader sepsis research community. Projects are expected to support the practical work of biospecimen collection and biobanking, along with robust, well-annotated clinical datasets that make samples interpretable and reusable. The FOA emphasizes scientific value: applicants should either leverage existing sepsis biospecimen collections or create new ones, then demonstrate and/or rigorously assess how valuable those collections are for answering real mechanistic questions in human sepsis. In parallel, the program seeks to generate clear guidance on best practices for collecting, using, and analyzing sepsis biospecimens, so that future studies can be more comparable across sites and yield results that are easier to reproduce and generalize.

The activity code structure (R21/R33) signals a phased approach. In NIH terms, this generally means an initial exploratory or feasibility phase (R21) followed by a second phase (R33) that supports an expanded effort once predefined milestones are met. In practice, the early phase would be used to establish or validate operating procedures, demonstrate that recruitment and sampling workflows are workable in critical care settings, confirm specimen quality and data completeness, and show that the collection can support meaningful mechanistic analyses. The later phase would then scale up collection, expand sharing capacity, and more fully establish the biospecimen resource as a platform for ongoing studies by the applicant team and, importantly, by other investigators.

The scope of supported work centers on biospecimens and the clinical context needed to interpret them. This includes banking and sharing specimens collected from critically ill patients in ways that preserve integrity for downstream analyses and pairing those specimens with standardized, high-value clinical variables. Because sepsis is heterogeneous and time-sensitive, the FOA implicitly prioritizes attention to timing of collection, consistency of processing, and the ability to relate samples to key clinical events, severity measures, treatments, and outcomes. The goal is to maximize the long-term scientific return of each sample by ensuring the associated metadata are robust enough to support modern mechanistic work, such as immunologic profiling, host response characterization, biomarker development, and stratification of sepsis subphenotypes.

Eligibility is broad across U.S.-based organizations and includes 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 and without 501(c)(3) status; for-profit organizations (other than small businesses); and small businesses. The FOA also explicitly highlights additional eligible applicant types such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, regional organizations, eligible federal agencies, Indian/Native American Tribal Governments (other than federally recognized), and U.S. territories or possessions. Foreign institutions are not eligible to apply, non-U.S. components of U.S. organizations are not eligible, and foreign components (as NIH defines them) are not allowed, reinforcing that the supported collection and infrastructure must be domestically based.

Administratively, this is an NIH grant mechanism under the discretionary category. The original closing date listed is 2022-11-16, and the FOA was created on 2020-11-13. While the summary you provided does not include a stated award ceiling or number of expected awards, the emphasis is clearly on building widely useful sepsis biospecimen resources and on producing practical, community-facing recommendations for best practices that can raise standards across human sepsis research.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Exploring the Scientific Value of Existing or New Sepsis Human Biospecimen Collections (R21/R33 - 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): 93.859.
• This funding opportunity was created on 2020-11-13.
• Applicants must submit their applications by 2022-11-16. (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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