Nonhuman Primate Transplantation Tolerance (U19) | Apply Online

Frequently Asked Questions (FAQs): Nonhuman Primate Transplantation Tolerance (U19) (RFA-AI-16-008)

What is the Nonhuman Primate Transplantation Tolerance (U19) opportunity (RFA-AI-16-008)?

It is a National Institute of Allergy and Infectious Diseases (NIAID) funding announcement supporting a coordinated, multi-center research effort focused on immune tolerance in transplantation using nonhuman primate (NHP) models. The program is organized under the Nonhuman Primate Transplantation Tolerance Cooperative Study Group (NHPCSG).

Which NIH institute is sponsoring this funding opportunity?

The opportunity is sponsored by NIAID, which is part of the National Institutes of Health (NIH) within the U.S. Department of Health and Human Services (HHS).

What does it mean that this is a U19 cooperative agreement?

A U19 is a cooperative agreement mechanism. In this context, it indicates that funded teams conduct the research while working closely with NIH program staff in an active partnership, consistent with how cooperative agreements are typically structured.

What is the NHPCSG?

NHPCSG stands for the Nonhuman Primate Transplantation Tolerance Cooperative Study Group. It is described as a collaborative network intended to produce rigorous, comparable preclinical evidence that can inform human clinical transplantation.

What is the main scientific focus of the program?

The focus is immune tolerance in transplantation, studied in nonhuman primate transplant models. The work is aimed at testing and refining tolerance induction strategies that could help transplant recipients accept grafts with minimal long-term reliance on broad immunosuppression.

Which transplant areas are included in the scientific scope?

The announcement highlights nonhuman primate models in four major transplant areas: kidney transplantation, pancreatic islet transplantation, heart transplantation, and lung transplantation.

What are the two major objectives emphasized in the announcement?

The two major objectives are: (1) evaluating preclinical safety and efficacy of existing and newly developed tolerance regimens in relevant NHP transplant models, and (2) clarifying the biology of tolerance by studying mechanisms of tolerance induction, maintenance, and failure (or loss of tolerance).

What kinds of research activities are implied by the opportunity?

Based on the description, activities can include immune monitoring, mechanistic studies of cellular and molecular pathways, and careful longitudinal assessment of graft function and immune responses in nonhuman primates, with an emphasis on understanding both whether a regimen works and why it works (and when it breaks down).

What is meant by “tolerance induction strategies” in this announcement?

It refers to approaches designed to help a transplant recipient accept a transplanted organ or tissue with reduced need for long-term broad immunosuppression, by inducing immune tolerance to the graft.

Why are nonhuman primate (NHP) models central to this program?

The program frames NHP studies as an essential translational bridge between rodent research and human clinical trials, especially in transplantation where immune systems, organ size, and clinical procedures are closer to human reality in primate models.

What is the long-term goal of the research supported by this opportunity?

The long-term translational goal is clinical: to develop and evaluate tolerance induction regimens that can ultimately improve long-term graft survival in human transplant recipients.

How does the multi-center structure affect the type of evidence the program wants?

The description emphasizes harmonized study designs, shared standards, and reproducible datasets across a cooperative, multi-site study group, with the intent of generating rigorous and comparable preclinical evidence that better predicts clinical outcomes.

Who is eligible to apply?

Eligibility is broad and includes domestic organizations such as: federally recognized tribal governments and tribal organizations; state and local governments; public housing authorities/Indian housing authorities; public and private institutions of higher education; nonprofit organizations with or without 501(c)(3) status (with exclusions as noted in the announcement); for-profit organizations other than small businesses; small businesses; and additional applicants as allowed under the announcement’s “additional eligibility” provisions.

What kinds of organizations might participate given the consortium-style approach described?

The description suggests a consortium model that could include academic medical centers, primate research facilities, hospitals, biotech companies, and specialized nonprofits, combining expertise in transplantation surgery, immunology, animal modeling, and immune monitoring.

Which federal department and agency are associated with this opportunity?

The opportunity is under the U.S. Department of Health and Human Services (HHS) and the National Institutes of Health (NIH), listed as HHS-NIH11.

What is the activity category for this funding opportunity?

The activity category listed for the opportunity is “Health.”

What CFDA numbers are associated with this announcement?

The CFDA numbers associated with the announcement are 93.855 and 93.856.

When was this funding opportunity posted and when did it close?

It was posted/created on April 19, 2016. The closing date was August 3, 2016, and the original and current closing dates match.

Does the provided announcement text state an award ceiling or the expected number of awards?

No. The provided text notes that it does not specify an award ceiling or an expected number of awards, and indicates applicants would typically need to consult the full solicitation for budget and project structure expectations.

Does the description explain how a U19 application should be structured (for example, components, cores, or governance)?

Not in the text provided. It states that details such as how many components a U19 application should include, core resources, governance, or shared infrastructure expectations would typically be found in the full solicitation.

What is the practical reason for emphasizing rigorous, comparable preclinical evidence?

The stated intent is to reduce uncertainty when moving toward human testing by producing reproducible datasets and more clinically predictive evidence from harmonized, multi-site nonhuman primate studies.