Emerging Science and Technology in Transplantation (U01 Clinical Trial Not Allowed) | RFA AI 21 016

Opportunity Information: Apply for RFA AI 21 016

The Emerging Science and Technology in Transplantation (U01 Clinical Trial Not Allowed) funding opportunity (RFA-AI-21-016) is a National Institutes of Health (NIH) cooperative agreement meant to build and support a coordinated research group focused on advancing transplantation immunology. The central aim is to bring together interdisciplinary teams and apply newer scientific tools and technology platforms to persistent problems in transplantation, especially the immune mechanisms that drive allograft rejection versus long-term acceptance. Rather than funding isolated projects, the FOA is structured to stimulate a collaborative, cooperative research effort where investigators work in a more integrated way with each other and with NIH program involvement that is typical of a U01 mechanism.

Scientifically, the FOA concentrates on three priority areas that NIH views as especially promising for near-term breakthroughs in transplant immunology. The first is microbiota, reflecting growing evidence that microbial communities (for example, in the gut or other body sites) can shape immune tone, influence inflammatory pathways, and potentially affect graft outcomes. The second is intravital imaging, which refers to advanced imaging approaches that allow researchers to visualize immune cells and tissue interactions in living organisms in real time, helping to uncover dynamics that conventional endpoint assays can miss. The third is targeted therapeutic delivery, emphasizing strategies to deliver drugs, biologics, or immune-modulating agents more precisely to relevant tissues or cell types, with the goal of improving efficacy and reducing systemic toxicity. Across these areas, the intent is that emerging technologies will generate new insights into alloimmune responses and open up practical paths to better diagnostics and interventions that prevent or treat rejection, or that promote immune tolerance.

From an outcomes perspective, the FOA is designed to accelerate the translation of cutting-edge science into transplant-relevant knowledge, such as identifying mechanisms and biomarkers that predict rejection risk, mapping immune cell behavior within graft tissue, and developing delivery methods that can selectively modulate immune responses. While the opportunity is oriented toward impactful, clinically meaningful transplantation science, it explicitly indicates "Clinical Trial Not Allowed," meaning applicants should propose preclinical, mechanistic, translational, or technology-development research that does not meet NIH’s definition of a clinical trial.

Organizationally, this is a discretionary federal funding opportunity under the health activity category (CFDA 93.855) using the cooperative agreement funding instrument type (U01). A cooperative agreement implies more substantial NIH involvement than a standard research grant, often including coordination across awardees and shared milestones or governance expectations consistent with a research group model.

Eligibility is broad across U.S.-based organizations and government entities. Eligible applicants include state, county, and city or township 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; other Native American tribal organizations; public housing/Indian housing authorities; nonprofit organizations (both 501(c)(3) and non-501(c)(3), excluding higher education where specified); for-profit organizations other than small businesses; and small businesses. The FOA also highlights inclusion of a wide range of institution types such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), as well as faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions.

At the same time, there are clear limits on non-U.S. participation. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply directly, and non-domestic components of U.S. organizations are also not eligible to apply. However, foreign components are allowed as defined by the NIH Grants Policy Statement, meaning a U.S. applicant organization may be able to include certain foreign collaborations or elements if they meet NIH’s definition and are appropriately justified and structured within NIH policy.

Key administrative details in the source information include an original closing date of September 3, 2021, and a creation date of May 11, 2021. The award ceiling and expected number of awards are not specified in the provided text, indicating applicants would typically need to consult the full FOA or NIH notices for budget and award volume details. Overall, the opportunity is best understood as NIH’s effort to organize and fund a coordinated set of research activities that push transplantation immunology forward by leveraging microbiome science, advanced real-time imaging, and precision delivery technologies, ultimately aiming to improve long-term graft outcomes and enable more durable immune tolerance strategies.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Emerging Science and Technology in Transplantation (U01 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 2021-05-11.
• Applicants must submit their applications by 2021-09-03. (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.

Apply for RFA AI 21 016

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