Opportunity Information: Apply for RFA AI 09 035

  • The National Institutes of Health in the health sector is offering a public funding opportunity titled "Immunobiology of Xenotransplantation (U01, U19)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.855 Allergy, Immunology and Transplantation Research.
  • This funding opportunity was created on Aug 11, 2009 and posted on Aug 11, 2009.
  • Applicants must submit their applications by Dec 2, 2009. (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.
  • Eligible applicants include: Public and State controlled institutions of higher education County governments City or township governments Native American tribal organizations (other than Federally recognized tribal governments) For profit organizations other than small businesses Private institutions of higher education Independent school districts Small businesses Others (see text field entitled Additional Information on Eligibility for clarification) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal governments (Federally recognized) Special district governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education State governments Public housing authorities/Indian housing authorities.
  • Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Eligible Agencies of the Federal Government Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Indian/Native American Tribal Governments (Other than Federally Recognized) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession.
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Opportunity Summary:

The Immunobiology of Xenotransplantation (U01, U19) funding opportunity (RFA-AI-09-035) is a National Institute of Allergy and Infectious Diseases (NIAID), NIH cooperative agreement program aimed at moving xenotransplantation closer to real clinical use. The program, called the Immunobiology of Xenotransplantation Cooperative Research Program (IXCRP), focuses specifically on building and refining rigorous preclinical models in which organs or tissues from pigs are transplanted into non-human primates (NHPs). The organ and tissue targets called out in the announcement include islets, kidney, heart, lung, and liver. In practical terms, the FOA is trying to support research teams that can use these pig-to-primate systems to answer the immunology and physiology questions that must be solved before xenotransplantation can be considered safe, durable, and predictable in people.

The scientific goals are organized around three connected needs. First, the program wants investigators to clearly map the cellular and molecular mechanisms that drive xenograft rejection and, on the other side of the equation, the mechanisms that enable immune tolerance. That means digging into the immune pathways, cells, and signals that cause acute and chronic rejection in these cross-species transplants, and identifying what conditions or interventions can shift the response toward acceptance. Second, the FOA emphasizes developing strategies that actually improve xenograft survival in these demanding models, moving beyond descriptive immunology toward interventions that extend function and prevent failure. Third, it highlights the importance of understanding physiological compatibility and limitations, recognizing that even if immunologic rejection can be controlled, organ function may still be constrained by cross-species differences in biology, regulation, or performance. The long-term objective tying all of this together is to generate credible, translatable approaches that could support eventual clinical xenotransplantation.

From a funding and structure standpoint, the announcement uses cooperative agreement mechanisms rather than standard research grants, specifically U01 for single-project efforts and U19 for multi-project efforts. Cooperative agreements generally mean there is expected to be substantial NIH program involvement, coordination, or partnership during the life of the award, which fits a field like xenotransplantation where standardized models, shared benchmarks, and coordinated progress can matter a lot. NIAID indicated an intention to commit about $2.5 million in total costs in fiscal year 2010 and expected to make roughly two to four awards across U01 and/or U19 applications, assuming sufficient funds and a strong pool of meritorious applications.

Administratively, this is a discretionary NIH funding opportunity in the health category under CFDA 93.855 (Allergy, Immunology and Transplantation Research), with no cost sharing or matching requirement. It was posted on August 11, 2009, with an application due date of December 2, 2009, and an archive date of January 2, 2010. Eligibility is broad and includes many common applicant types across academia, government, nonprofit, and industry, such as public and private institutions of higher education, for-profit organizations (including small businesses), nonprofits with or without 501(c)(3) status, and various government entities (state, local, special district). The eligibility language also explicitly includes a range of mission- or population-focused institutions and jurisdictions, such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, U.S. territories or possessions, and tribal governments (federally recognized and other than federally recognized), among others.

Overall, the opportunity is best understood as a targeted investment by NIAID to accelerate progress on the core immunobiology and functional biology hurdles that limit pig-to-primate xenotransplantation, with an emphasis on robust preclinical models, intervention development, and coordinated, NIH-engaged research teams using U01 and U19 cooperative agreements.

Frequently Asked Questions (FAQ)

What is this funding opportunity?

This opportunity is the NIH/NIAID cooperative agreement program titled The Immunobiology of Xenotransplantation (U01, U19), Funding Opportunity Announcement (FOA) number RFA-AI-09-035. It supports research intended to move xenotransplantation closer to real clinical use by strengthening the preclinical evidence base.

What program is this part of?

It is part of the Immunobiology of Xenotransplantation Cooperative Research Program (IXCRP).

What is the overall purpose of the IXCRP?

The program is aimed at building and refining rigorous preclinical models where pig organs or tissues are transplanted into non-human primates (NHPs), so researchers can address key immunology and physiology questions required before xenotransplantation could be considered safe, durable, and predictable in humans.

What types of transplants does the FOA focus on?

The FOA focuses on pig-to-non-human primate xenotransplantation models (organs/tissues from pigs transplanted into NHP recipients).

Which organs or tissues are specifically called out as targets?

The announcement specifically calls out: islets, kidney, heart, lung, and liver.

What are the main scientific goals of the program?

The FOA organizes the scientific goals around three connected needs:

  • Mechanisms of rejection and tolerance: mapping the cellular and molecular mechanisms that drive xenograft rejection and identifying mechanisms that enable immune tolerance.
  • Strategies to improve survival: developing strategies and interventions that improve xenograft survival in demanding pig-to-primate models, going beyond descriptive immunology.
  • Physiological compatibility: understanding cross-species physiological compatibility and limitations that could constrain organ function even if immunologic rejection is controlled.

What does the FOA mean by studying mechanisms of rejection and tolerance?

Based on the FOA description, this includes investigating the immune pathways, cells, and signals that cause acute and chronic rejection in cross-species transplants, and identifying conditions or interventions that shift responses toward acceptance (immune tolerance).

Does the opportunity emphasize intervention development or only basic characterization?

It explicitly emphasizes moving beyond descriptive immunology toward strategies and interventions that improve xenograft survival and extend function in these preclinical models.

Why is physiological compatibility highlighted?

The FOA notes that even if immunologic rejection can be controlled, organ function may still be limited by cross-species differences in biology, regulation, or performance. Understanding these constraints is a core program priority.

What is the long-term objective of the research supported by this FOA?

The long-term objective is to generate credible, translatable approaches that could support eventual clinical xenotransplantation.

What funding mechanisms are used?

This FOA uses NIH cooperative agreement mechanisms: U01 (single-project efforts) and U19 (multi-project efforts).

What is the difference between U01 and U19 in this announcement?

As described in the FOA summary:

  • U01 supports a single-project effort.
  • U19 supports a multi-project effort.

What does it mean that this is a cooperative agreement?

In this FOA, cooperative agreements indicate expected substantial NIH program involvement, coordination, or partnership during the award. The description ties this to the need for standardized models, shared benchmarks, and coordinated progress in xenotransplantation research.

Which NIH Institute is sponsoring this opportunity?

The sponsoring Institute is the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).

How much funding did NIAID intend to commit?

NIAID indicated an intention to commit about $2.5 million in total costs in fiscal year 2010, assuming availability of funds.

How many awards were expected?

NIAID expected to make approximately two to four awards across U01 and/or U19 applications, assuming sufficient funds and a strong pool of meritorious applications.

What is the CFDA number and program category?

The FOA is listed under CFDA 93.855, titled Allergy, Immunology and Transplantation Research, and it is in the health category.

Is cost sharing or matching required?

No. The FOA specifies no cost sharing or matching requirement.

What type of funding opportunity is this administratively?

It is described as a discretionary NIH funding opportunity in the health category.

When was the FOA posted?

The FOA was posted on August 11, 2009.

What was the application due date?

The application due date was December 2, 2009.

When was the archive date?

The archive date was January 2, 2010.

Who is eligible to apply?

Eligibility is broad and includes many applicant types across academia, government, nonprofit, and industry, including:

  • Public and private institutions of higher education
  • For-profit organizations (including small businesses)
  • Nonprofits with or without 501(c)(3) status
  • Government entities (state, local, special district)

Does the eligibility language explicitly include minority-serving or mission-focused institutions?

Yes. The eligibility language explicitly includes, among others, HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, and applicants in U.S. territories or possessions.

Are tribal governments included as eligible applicants?

Yes. The eligibility language explicitly includes tribal governments, both federally recognized and other than federally recognized.

What kind of research teams is this FOA trying to support?

It is trying to support research teams that can use pig-to-primate preclinical systems to answer the immunology and physiology questions that need to be solved before xenotransplantation can be considered safe and predictable in humans, with an emphasis on robust models, intervention development, and coordinated NIH-engaged efforts.

Why does the FOA emphasize robust preclinical models?

The FOA frames rigorous pig-to-NHP models as the practical foundation for generating credible evidence about rejection mechanisms, tolerance strategies, graft survival interventions, and physiological compatibility constraints that would be relevant to eventual clinical use.

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