Opportunity Information: Apply for RFA AI 14 048
Apply for RFA AI 14 048
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Immunobiology of Xenotransplantation (U01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.855 Allergy and Infectious Diseases Research 93.856 Microbiology and Infectious Diseases Research.
- This funding opportunity was created on Jul 18, 2014 and posted on Jul 18, 2014.
- Applicants must submit their applications by Nov 20, 2014. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $2,500,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $2,500,000.00 in funding.
- Eligible applicants include: Native American tribal organizations (other than Federally recognized tribal governments) Small businesses Others (see text field entitled Additional Information on Eligibility for clarification) Independent school districts Public and State controlled institutions of higher education State governments Native American tribal governments (Federally recognized) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Public housing authorities/Indian housing authorities Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments County governments Private institutions of higher education For profit organizations other than small businesses City or township governments.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISISs) Eligible Agencies of the Federal Government Faith based or Community based Organizations Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Indian/Native American Tribal Governments (Other than Federally Recognized) Non domestic (non U.S.) Entities (Foreign Organizations) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession Non domestic (non U.S.) Entities (Foreign Institutions) are not eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
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Opportunity Summary:
The Immunobiology of Xenotransplantation (U01) funding opportunity (RFA-AI-14-048) is a National Institutes of Health (NIH) cooperative agreement designed to build a coordinated research program focused on xenotransplantation, specifically the transplantation of pig (porcine) organs or tissues into nonhuman primates (NHPs) as a critical preclinical step toward eventual human clinical use. The announcement solicits applications to participate in the Immunobiology of Xenotransplantation Cooperative Research Program (IXCRP), with an emphasis on developing and using rigorous porcine-to-NHP transplant models for islet, kidney, heart, lung, or liver xenotransplantation. In practical terms, the program is looking for teams that can run well-controlled, clinically relevant animal studies that generate mechanistic insights and test interventions that meaningfully extend graft function and survival.
The scientific goals are centered on understanding and controlling the immune response to xenografts. First, the program aims to delineate the cellular and molecular mechanisms that drive xenograft rejection as well as the mechanisms that can lead to immune tolerance. This includes mapping which immune cells and pathways are responsible for early and late graft injury, identifying key inflammatory and coagulation-related processes that are uniquely problematic across species barriers, and clarifying how innate and adaptive immunity interact in xenotransplant settings. Second, the program intends to support development of effective strategies that improve xenograft survival. That can include immunomodulatory approaches, tolerance-induction strategies, or other interventions that reduce rejection risk and prolong function in these demanding preclinical models. Third, it aims to characterize the physiological compatibility and limitations of xenografts, recognizing that success is not only about avoiding immune destruction but also about ensuring that the transplanted pig organ or tissue can perform appropriately in a primate recipient, with acceptable function, metabolism, and long-term stability.
The long-term objective is translational: to produce novel, effective strategies that can ultimately support safe and durable xenotransplantation in the clinic. By requiring robust pig-to-NHP models, the initiative is trying to ensure that results move beyond simplified experiments and instead address the kinds of immunologic, physiologic, and practical challenges that would matter for human application. Because this is a U01 cooperative agreement rather than a standard research grant, awardees should expect substantial NIH programmatic involvement, coordination, and shared expectations around milestones, data sharing, and participation in a larger collaborative research effort. In many NIH cooperative programs, the intent is not just to fund isolated projects but to assemble a network where projects complement each other and collectively drive the field forward.
From an administrative standpoint, the opportunity falls under NIH’s health research mission areas tied to Allergy and Infectious Diseases Research (CFDA 93.855) and Microbiology and Infectious Diseases Research (CFDA 93.856). The total estimated funding listed for the opportunity is $2,500,000, and the award ceiling is also $2,500,000, with no cost sharing or matching requirement. The FOA was posted on July 18, 2014, with an original and current closing date of November 20, 2014, and it was archived on December 21, 2014, meaning it is no longer open for applications but remains relevant as a record of NIH priorities and a template for similar future solicitations.
Eligibility is broad across U.S.-based organizations and institutions. Eligible applicants include public and state-controlled institutions of higher education, private institutions of higher education, nonprofits (including 501(c)(3) and certain non-501(c)(3) entities), small businesses, and for-profit organizations other than small businesses, along with various levels of government (state, county, city/township, special district), public housing authorities/Indian housing authorities, and Native American tribal governments (federally recognized) as well as tribal organizations. The eligibility language also explicitly includes a range of mission-specific institution types such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribal Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), along with faith-based or community-based organizations and eligible federal agencies. Non-U.S. entities (foreign organizations or foreign institutions) are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible; however, foreign components (as NIH defines them in policy) are allowed, which typically means a U.S. applicant may include certain discrete foreign activities under the award if justified and permitted under NIH rules.
For access and troubleshooting, the announcement points applicants to the NIH Grants Guide web listing and provides NIH Office of Extramural Research (OER) webmaster contact emails for technical difficulties in accessing or linking to the full FOA.
Frequently Asked Questions (FAQs): The Immunobiology of Xenotransplantation (U01) - RFA-AI-14-048
1) What is this funding opportunity?
This opportunity, titled The Immunobiology of Xenotransplantation (U01) (FOA: RFA-AI-14-048), is a National Institutes of Health (NIH) cooperative agreement intended to build a coordinated research program in xenotransplantation. It focuses on transplanting pig (porcine) organs or tissues into nonhuman primates (NHPs) as an essential preclinical step toward eventual human clinical use.
2) What program does this FOA support?
The FOA solicits applications to participate in the Immunobiology of Xenotransplantation Cooperative Research Program (IXCRP). The goal is to assemble complementary projects into a coordinated program rather than fund isolated, stand-alone studies.
3) What is the main scientific focus of the program?
The central focus is the immune response to xenografts and how to understand, control, and improve outcomes in pig-to-NHP transplant models. The program emphasizes generating mechanistic insight and testing interventions that meaningfully extend graft function and survival.
4) What types of xenotransplant models are emphasized?
The program emphasizes rigorous porcine-to-NHP transplant models designed to be well-controlled and clinically relevant. The FOA highlights these transplant areas: islet, kidney, heart, lung, and liver xenotransplantation.
5) What kinds of studies does NIH appear to be looking for?
Based on the description, NIH is seeking teams capable of running well-controlled, clinically relevant animal studies in pig-to-NHP xenotransplantation. The studies are expected to produce mechanistic findings and to evaluate interventions that extend graft performance and survival in demanding preclinical settings.
6) What are the key scientific goals described in the announcement?
The announcement describes three primary scientific goals:
- Delineate mechanisms of rejection and tolerance, including cellular and molecular drivers of early and late graft injury.
- Develop strategies to improve xenograft survival, including immunomodulation and tolerance-induction or other approaches to reduce rejection and prolong function.
- Characterize physiological compatibility and limitations of pig organs/tissues in primate recipients, including function, metabolism, and long-term stability (not just avoidance of immune-mediated destruction).
7) Does the FOA focus only on immunology?
No. While the core emphasis is immunobiology (rejection, tolerance, innate/adaptive immunity), the FOA also explicitly includes physiological compatibility and limitations of xenografts, recognizing that successful xenotransplantation requires both immune control and acceptable organ/tissue performance in the recipient.
8) What immune processes are specifically highlighted as important?
The FOA highlights the need to map which immune cells and pathways drive early and late graft injury, understand innate and adaptive immune interactions, and identify key inflammatory and coagulation-related processes that are uniquely challenging across species barriers.
9) What is the long-term objective of the program?
The long-term objective is translational: to generate novel, effective strategies that can ultimately support safe and durable clinical xenotransplantation. The pig-to-NHP model requirement is intended to keep the work aligned with challenges relevant to eventual human application.
10) What does it mean that this is a U01 cooperative agreement?
A U01 is an NIH cooperative agreement, which generally implies substantial NIH programmatic involvement. Awardees should expect coordination and shared expectations around items such as milestones, data sharing, and participation in a broader collaborative research effort (as described in the announcement).
11) Is this a single-project grant or part of a broader network?
The announcement indicates the intent is to build a coordinated program/network (IXCRP) where projects complement each other and collectively advance the field, rather than supporting purely independent projects.
12) What NIH mission areas or CFDA programs are associated with this FOA?
Administratively, the opportunity is tied to NIH health research mission areas associated with:
- Allergy and Infectious Diseases Research (CFDA 93.855)
- Microbiology and Infectious Diseases Research (CFDA 93.856)
13) How much funding is associated with this opportunity?
The FOA lists total estimated funding of $2,500,000 and an award ceiling of $2,500,000.
14) Is cost sharing or matching required?
No. The opportunity states there is no cost sharing or matching requirement.
15) Is this FOA still open for applications?
No. The FOA is archived (archived date: December 21, 2014). The original and current closing date listed is November 20, 2014, so it is no longer accepting applications.
16) When was the FOA posted and when did it close?
The FOA was posted on July 18, 2014. The original and current closing date is November 20, 2014.
17) Who is eligible to apply?
Eligibility is broad for U.S.-based organizations and institutions. Eligible applicants listed include:
- Public and state-controlled institutions of higher education
- Private institutions of higher education
- Nonprofits (including 501(c)(3) and certain non-501(c)(3) entities)
- Small businesses
- For-profit organizations other than small businesses
- State governments
- County governments
- City or township governments
- Special district governments
- Public housing authorities / Indian housing authorities
- Native American tribal governments (federally recognized)
- Native American tribal organizations (other than federally recognized tribal governments)
- Eligible federal agencies
- Faith-based or community-based organizations
18) Are minority-serving institutions explicitly included?
Yes. The eligibility language explicitly includes institution types such as:
- Historically Black Colleges and Universities (HBCUs)
- Hispanic-serving institutions
- Tribal Colleges and Universities (TCCUs)
- Alaska Native and Native Hawaiian Serving Institutions
- Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)
19) Can foreign organizations apply?
No. The announcement states that non-U.S. entities (foreign organizations or foreign institutions) are not eligible to apply.
20) Are non-U.S. components of U.S. organizations eligible?
No. The FOA states that non-U.S. components of U.S. organizations are not eligible.
21) Are foreign components allowed at all under this program?
Yes. While foreign organizations cannot apply and non-U.S. components of U.S. organizations are not eligible, the FOA indicates that foreign components (as NIH defines them in policy) are allowed. In practical terms, this means a U.S. applicant may be able to include certain discrete foreign activities if justified and permitted under NIH rules (as referenced in the announcement).
22) Where can applicants find the official listing and help with access issues?
The announcement points users to the NIH Grants Guide web listing and provides NIH Office of Extramural Research (OER) webmaster contact emails for technical difficulties related to accessing or linking to the full FOA.
23) Why is this archived FOA still useful?
Even though it is no longer open, the archived FOA can still be useful as a record of NIH priorities in xenotransplantation and as a template for similar future solicitations that may use related program structures, expectations, and scientific themes.
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