Nonhuman Primate Transplantation Tolerance Cooperative Study Group (U19 Clinical Trial Not Allowed) | RFA AI 22 003

Opportunity Information: Apply for RFA AI 22 003

The National Institutes of Health (NIH) released this funding opportunity, RFA AI 22 003, to establish the Nonhuman Primate Transplantation Tolerance Cooperative Study Group (NHPCSG) as a multi-center cooperative program. The scientific focus is on developing, refining, and rigorously evaluating strategies that can induce and sustain immune tolerance to allogeneic (donor-derived) transplants using nonhuman primate (NHP) models. In practical terms, the program is meant to help researchers move beyond temporary immunosuppression and toward approaches that train the immune system to accept a transplanted organ or tissue long-term, with the broader aim of enabling safer, more durable graft survival and creating a clear path toward eventual clinical translation in humans.

This opportunity uses a U19 cooperative agreement mechanism, which typically means NIH expects a coordinated, collaborative structure across multiple sites rather than a collection of independent projects. Under a cooperative agreement, NIH staff generally have substantial involvement in the program's oversight, coordination, and milestone-driven progress, reflecting the "team science" nature of a study group. The "Clinical Trial Not Allowed" designation signals that applications should not propose clinical trials in humans under this award; instead, the work is centered on preclinical transplantation tolerance research in NHP models, with emphasis on generating evidence and protocols strong enough to inform future clinical studies supported under different mechanisms.

The overarching goal of the NHPCSG is to accelerate the translation of tolerance-induction protocols that are both effective and safe. That includes optimizing protocols that can maintain long-term graft function while reducing the harms associated with chronic immunosuppressive drugs, such as infection risk, malignancy risk, metabolic complications, and drug toxicity. By emphasizing nonhuman primate models, the RFA is targeting a translationally relevant step between small-animal studies and human application, because NHP immune systems, transplant physiology, and clinical management considerations often more closely mirror human transplantation than rodent models do.

Eligibility is broad and includes many common applicant types, such as state and local governments, public and private institutions of higher education, nonprofit organizations (with or without 501(c)(3) status), for-profit organizations (other than small businesses), and small businesses. It also explicitly includes a range of mission- and community-oriented institutions and organizations 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 and eligible federal agencies. In addition, certain tribal entities beyond federally recognized tribal governments are noted as eligible in the listing.

Foreign eligibility is limited in an important way. Non-domestic (non-U.S.) entities, meaning foreign organizations and foreign institutions, are not eligible to apply as the applicant organization. Non-domestic components of U.S. organizations are also not eligible to apply. However, "foreign components" as defined by the NIH Grants Policy Statement are allowed, which generally means a U.S.-based applicant may include specific, well-justified elements of the project that occur outside the U.S. when they are necessary for the project and meet NIH policy requirements.

From an administrative standpoint, the opportunity is categorized as discretionary funding, uses the cooperative agreement funding instrument, and falls under the health activity category. The CFDA number associated with the program is 93.855, and NIH is the sponsoring agency. The original closing date listed for applications was 2022-05-13, and the opportunity record shows a creation date of 2022-01-18. The public synopsis provided does not specify an award ceiling or the expected number of awards in the excerpted fields, so applicants would typically need to consult the full RFA text for budget structure, project period expectations, and the planned scale of the consortium.

Overall, this RFA is essentially about building a coordinated NHP research consortium to produce robust, comparable, and translatable evidence on how to achieve transplant tolerance across different centers. The intent is to standardize and test promising tolerance strategies in a rigorous, collaborative setting so that the most effective and safest approaches can be positioned for later human testing, while keeping this particular award focused on nonhuman primate preclinical research rather than human clinical trials.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Nonhuman Primate Transplantation Tolerance Cooperative Study Group (U19 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 2022-01-18.
• Applicants must submit their applications by 2022-05-13. (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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