Opportunity Information: Apply for RFA AI 22 002
The National Institutes of Health (NIH) is soliciting applications under Funding Opportunity Number RFA-AI-22-002 for the Nonhuman Primate Transplantation Tolerance Cooperative Study Group (NHPCSG). This is a discretionary health funding opportunity (CFDA 93.855) using the U01 cooperative agreement mechanism, meaning funded projects are expected to operate as a coordinated program with substantial NIH programmatic involvement rather than as fully independent investigator-initiated grants. The funding opportunity is explicitly labeled "Clinical Trial Not Allowed," indicating that the supported work must not include human clinical trials; the focus is on preclinical research and translational preparation using nonhuman primate (NHP) models.
The central purpose of the NHPCSG is to build and run a multi-center cooperative research program aimed at developing, optimizing, and rigorously evaluating strategies that can induce and maintain immune tolerance to allogeneic transplants in NHPs. In practical terms, the program is meant to help the field move beyond chronic immunosuppression by testing approaches that teach the recipient immune system to accept a transplanted organ or tissue from a genetically different donor without ongoing broad immune suppression. By using NHP models, the program targets a level of biological and immunological similarity to humans that is generally considered more predictive for transplantation outcomes than smaller-animal models, with the intention of reducing the risk and uncertainty when transitioning promising tolerance protocols toward clinical use.
The overarching goal is clinical translation, but through a preclinical pathway: generating the evidence, optimization steps, and comparative performance data needed to identify tolerance-induction protocols that are both effective and safe enough to justify future human testing in separate, appropriately designed clinical studies. This includes demonstrating long-term graft survival and durable immune tolerance, while also paying close attention to safety issues that can derail translation, such as infection risk, malignancy risk, off-target immune effects, graft-versus-host-like phenomena in certain settings, and other complications that may emerge when manipulating the immune system to achieve tolerance.
Because this is structured as a cooperative study group, applicants should expect an emphasis on collaboration across multiple centers, harmonized or comparable experimental designs where appropriate, shared standards for key endpoints and immunologic monitoring, and coordinated decision-making that supports the group mission. Cooperative programs like this typically value the ability to execute complex NHP transplantation studies with consistent quality, robust oversight, and the infrastructure needed for specialized assays, longitudinal follow-up, and cross-site data integration, all of which support the stated goal of producing results that are credible and usable for eventual clinical planning.
Eligibility is broad across U.S.-based organizational types. Eligible applicants include state, county, 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 authorities/Indian housing authorities; nonprofit organizations (both 501(c)(3) and non-501(c)(3), excluding institutions of higher education in those nonprofit categories as specified); for-profit organizations other than small businesses; small businesses; and other entities. The announcement also highlights additional eligible applicant categories 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), eligible federal agencies, faith-based or community-based organizations, regional organizations, and U.S. territories or possessions.
Foreign eligibility is restricted in a way that is common for NIH cooperative programs. Non-domestic (non-U.S.) entities (foreign organizations and foreign institutions) are not eligible to apply as the applicant organization, and non-domestic components of U.S. organizations are also not eligible to apply. However, foreign components, as defined in the NIH Grants Policy Statement, are allowed. In effect, a U.S. applicant may be able to include certain foreign collaborations or activities as a component of the project when justified and allowable under NIH policy, but the primary applicant institution and its eligible components must be domestic.
Key administrative details provided in the source information include the agency (NIH), the original closing date (2022-05-13), and the creation date of the opportunity record (2022-01-18). The listing does not specify an award ceiling or the expected number of awards in the provided fields, so applicants would typically need to consult the full RFA text for budget guidance, the anticipated scale of the program, and any institute- or program-specific expectations regarding the number of participating centers, required cores, or mandated governance structures.
In summary, this opportunity is designed to accelerate progress toward practical, clinically relevant transplantation tolerance by supporting a coordinated, multi-center set of NHP studies that can identify and refine tolerance-induction approaches with strong evidence for durable graft acceptance and acceptable safety, while operating under a cooperative agreement structure that prioritizes shared goals, alignment across participating sites, and NIH involvement in program coordination.Apply for RFA AI 22 002
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Nonhuman Primate Transplantation Tolerance Cooperative Study Group (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 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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Frequently Asked Questions (FAQs)
What is the funding opportunity number and program name?
This opportunity is Funding Opportunity Number (FON) RFA-AI-22-002 for the Nonhuman Primate Transplantation Tolerance Cooperative Study Group (NHPCSG) through the National Institutes of Health (NIH).
Which agency is offering this grant?
The agency offering this opportunity is the National Institutes of Health (NIH).
What is the assistance listing / CFDA number for this opportunity?
The opportunity is listed as CFDA 93.855.
What type of award mechanism is being used?
The funding mechanism is a U01 cooperative agreement. This means funded projects are expected to operate as a coordinated program with substantial NIH programmatic involvement, rather than as fully independent investigator-initiated projects.
What does it mean that this is a cooperative agreement (U01)?
Under a cooperative agreement, the work is structured as a coordinated program. The information provided indicates there will be substantial NIH involvement and an expectation of collaboration, harmonized or comparable study designs where appropriate, shared standards for endpoints and monitoring, and coordinated decision-making in support of the group mission.
Are human clinical trials allowed under this opportunity?
No. The opportunity is explicitly labeled "Clinical Trial Not Allowed," meaning the supported work must not include human clinical trials.
If clinical trials are not allowed, what kind of work is this meant to support?
The focus is on preclinical research and translational preparation using nonhuman primate (NHP) models, aimed at producing evidence and optimization data to support future human testing in separate clinical studies.
What is the central purpose of the NHPCSG program?
The central purpose is to build and run a multi-center cooperative research program to develop, optimize, and rigorously evaluate strategies that can induce and maintain immune tolerance to allogeneic transplants in nonhuman primates.
What does "transplantation tolerance" mean in the context of this opportunity?
Based on the description provided, tolerance strategies are approaches intended to teach the recipient immune system to accept a transplanted organ or tissue from a genetically different donor without ongoing broad (chronic) immunosuppression.
What kinds of transplants are in scope for these studies?
The opportunity describes tolerance to allogeneic transplants in nonhuman primates. The specific organ or tissue types are not detailed in the provided information, so the full RFA would typically be consulted for any more specific scope.
Why does this program emphasize nonhuman primate (NHP) models?
The description indicates NHP models are used because they provide biological and immunological similarity to humans that is generally considered more predictive for transplantation outcomes than smaller-animal models, helping reduce risk and uncertainty when moving promising tolerance protocols toward clinical use.
What is the overarching goal of the NHPCSG?
The overarching goal is clinical translation through a preclinical pathway. The program is intended to generate evidence, optimization steps, and comparative performance data needed to identify tolerance-induction protocols that are effective and safe enough to justify future human testing in separate clinical studies.
What types of outcomes or endpoints are emphasized in the program description?
The program description emphasizes demonstrating long-term graft survival and durable immune tolerance, along with careful attention to safety outcomes relevant to translation.
What safety considerations are specifically highlighted?
The description highlights safety issues that can derail translation, including infection risk, malignancy risk, off-target immune effects, graft-versus-host-like phenomena in certain settings, and other complications that may emerge when manipulating the immune system to achieve tolerance.
Is this opportunity intended to replace chronic immunosuppression?
The program is described as aiming to help the field move beyond chronic immunosuppression by testing approaches that promote immune acceptance of the graft without ongoing broad immune suppression.
Is a multi-center approach expected?
Yes. The opportunity is described as a multi-center cooperative research program with an emphasis on collaboration across multiple centers.
What types of coordination are expected across participating centers?
The description indicates expectations such as harmonized or comparable experimental designs where appropriate, shared standards for key endpoints and immunologic monitoring, coordinated decision-making supporting the group mission, and cross-site data integration.
What capabilities or infrastructure does the opportunity imply applicants should have?
The description suggests cooperative programs like this value the ability to execute complex NHP transplantation studies with consistent quality and robust oversight, as well as infrastructure for specialized assays, longitudinal follow-up, and cross-site data integration.
Who is eligible to apply?
Eligibility is broad across U.S.-based organizational types. Eligible applicants include (as listed in the description): state, county, 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 authorities/Indian housing authorities; nonprofit organizations (501(c)(3) and non-501(c)(3), excluding institutions of higher education in those nonprofit categories as specified); for-profit organizations other than small businesses; small businesses; and other entities.
Are institutions serving specific communities explicitly included as eligible?
Yes. The description highlights additional eligible applicant categories 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), and Tribally Controlled Colleges and Universities (TCCUs).
Are faith-based or community-based organizations eligible?
Yes. The description lists faith-based or community-based organizations among the highlighted eligible categories.
Are U.S. territories or possessions eligible to apply?
Yes. The description includes U.S. territories or possessions among eligible categories.
Can a foreign (non-U.S.) organization apply as the primary applicant?
No. The description states that non-domestic (non-U.S.) entities (foreign organizations and foreign institutions) are not eligible to apply as the applicant organization.
Are non-domestic components of U.S. organizations eligible to apply?
No. The description states that non-domestic components of U.S. organizations are also not eligible to apply.
Are foreign components allowed in any form?
Yes. The description states that foreign components, as defined in the NIH Grants Policy Statement, are allowed. In practical terms, a U.S. applicant may be able to include certain foreign collaborations or activities as a component of the project when justified and allowable under NIH policy.
What is the original closing date listed for this opportunity?
The original closing date provided is 2022-05-13.
What is the opportunity record creation date?
The opportunity record creation date provided is 2022-01-18.
Does the provided listing specify an award ceiling?
No. The provided information states that the listing does not specify an award ceiling in the fields shown, and applicants would typically need to consult the full RFA text for budget guidance.
Does the provided listing specify the expected number of awards?
No. The provided information states that the expected number of awards is not specified in the fields shown, and applicants would typically need to consult the full RFA text for details about anticipated scale and structure.
What should applicants do to find budget guidance and program structure requirements?
Based on the information provided, applicants would typically consult the full RFA text for budget guidance, the anticipated scale of the program, and any institute- or program-specific expectations (such as number of participating centers, required cores, or governance structures).
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