Opportunity Information: Apply for RFA AI 12 005
Apply for RFA AI 12 005
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Clinical Trials in Organ Transplantation in Children (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 Jan 26, 2012 and posted on Jan 4, 2012.
- Applicants must submit their applications by May 4, 2012. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $4,300,000.00 to eligible and selected applicants.
- Eligible applicants include: Small businesses Public and State controlled institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Others (see text field entitled Additional Information on Eligibility for clarification) Special district governments City or township governments Native American tribal governments (Federally recognized) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts County governments State governments For profit organizations other than small businesses Public housing authorities/Indian housing authorities Private institutions of higher education.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions 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) 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 eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
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Opportunity Summary:
The Clinical Trials in Organ Transplantation in Children (CTOT-C) (U01) funding opportunity (RFA-AI-12-005) is a National Institutes of Health program led by the National Institute of Allergy and Infectious Diseases (NIAID) to support a coordinated research consortium focused on pediatric solid organ transplantation. The program is designed for institutions that can work together to run multi-site clinical research in children and adolescents who are under 21 years old at the time they enroll. Eligible transplant populations include recipients of heart, lung, liver, small intestine, and kidney transplants. The overall goal is to improve long-term outcomes in pediatric transplant recipients by addressing problems that drive late graft dysfunction, graft loss, and immune-mediated illness and death that are especially relevant in children.
The opportunity uses a cooperative agreement mechanism (U01), which typically means the funded teams will not only receive financial support but will also work closely with NIH staff in planning and carrying out the research agenda. Funding is intended to enable Phase I, Phase II, and Phase III clinical trials as well as observational clinical studies. A key feature is that clinical studies are expected to be paired with mechanistic investigations, meaning applicants should include laboratory and translational components aimed at understanding the underlying immune and biological processes that influence graft function, rejection, tolerance, infection risk, and other transplant-related complications in children. In practice, this supports research that can connect what happens clinically (for example, rejection episodes, medication toxicity, infection, chronic graft deterioration) with measurable immune signatures or pathways that explain why outcomes occur and how they might be prevented.
The emphasis on pediatrics reflects the reality that children have unique immunology, growth and development considerations, long expected lifespans after transplant, and prolonged exposure to immunosuppression, all of which can shape both short-term risks and long-term morbidity. By focusing on strategies to reduce late graft injury and immune-driven complications, the CTOT-C program is aimed at producing evidence that can improve durable graft survival, minimize treatment-related harm, and reduce mortality that stems from immune dysfunction, such as severe infection, chronic rejection processes, or other immune-mediated conditions.
This announcement is classified as a discretionary grant opportunity within the NIH health research activity area. It lists CFDA numbers 93.855 (Allergy and Infectious Diseases Research) and 93.856 (Microbiology and Infectious Diseases Research). The estimated total funding level is $4.3 million, and there is no cost sharing or matching requirement. The opportunity was posted January 4, 2012, created January 26, 2012, with an original closing date of April 18, 2012, later extended to May 4, 2012, and archived June 4, 2012.
Eligibility is broad across U.S.-based organizations and can include public and private institutions of higher education, nonprofits (including those with and without 501(c)(3) status), small businesses and other for-profit organizations (other than small businesses), and a variety of government entities such as state, county, city/township, special district governments, and independent school districts. The eligibility list also highlights inclusion of community-based and faith-based organizations, eligible federal agencies, and a range of mission-focused institutions such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Alaska Native and Native Hawaiian-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), and tribal organizations and governments (including federally recognized tribal governments). Non-U.S. entities (foreign institutions) are not eligible to apply as primary applicants, but non-U.S. components of U.S. organizations may participate, and foreign components as defined by NIH policy are allowed, enabling certain international collaborations when tied to a U.S. applicant.
In short, this FOA is meant to build and sustain a pediatric transplant clinical research network capable of running rigorous trials and well-designed observational studies, while simultaneously generating mechanistic data to explain outcomes and guide future therapies. The program’s practical deliverable is better long-term transplant success in children through evidence-based approaches that prevent chronic graft decline and reduce immune-related complications that can shorten lives or diminish quality of life after pediatric organ transplantation.
Frequently Asked Questions (FAQs)
What is the Clinical Trials in Organ Transplantation in Children (CTOT-C) (U01) funding opportunity?
CTOT-C is a National Institutes of Health (NIH) grant opportunity (RFA-AI-12-005) led by the National Institute of Allergy and Infectious Diseases (NIAID). It is intended to support a coordinated research consortium focused on pediatric solid organ transplantation and multi-site clinical research in children and adolescents.
What is the main goal of the CTOT-C program?
The overall goal is to improve long-term outcomes in pediatric transplant recipients by addressing problems that drive late graft dysfunction, graft loss, and immune-mediated illness and death that are especially relevant in children.
What ages are included in the pediatric population for this program?
The program targets children and adolescents who are under 21 years old at the time they enroll in the clinical research.
Which transplanted organs are included under this opportunity?
Eligible transplant populations include recipients of heart, lung, liver, small intestine, and kidney transplants.
What type of funding mechanism is used (U01), and what does that imply?
This opportunity uses a cooperative agreement mechanism (U01). In general, this indicates that funded teams receive financial support and are also expected to work closely with NIH staff in planning and carrying out the research agenda.
What kinds of studies can be supported through this FOA?
Funding is intended to enable Phase I, Phase II, and Phase III clinical trials, as well as observational clinical studies, in pediatric solid organ transplantation.
Are mechanistic or laboratory components expected as part of the clinical research?
Yes. A key feature of this FOA is that clinical studies are expected to be paired with mechanistic investigations. Applicants are expected to include laboratory and translational components aimed at understanding immune and biological processes that influence outcomes such as graft function, rejection, tolerance, infection risk, and other transplant-related complications in children.
What does it mean to connect clinical outcomes with mechanistic investigations?
In practice, it supports research that links clinical events (for example, rejection episodes, medication toxicity, infection, or chronic graft deterioration) with measurable immune signatures or pathways to help explain why outcomes occur and how they might be prevented.
Why is there a specific emphasis on pediatrics in this program?
The FOA emphasizes pediatrics because children have unique immunology and growth/development considerations, long expected lifespans after transplant, and prolonged exposure to immunosuppression. These factors can shape both short-term risks and long-term morbidity, making pediatric-specific evidence especially important.
What types of complications or outcome drivers is the program trying to address?
The program is focused on strategies to reduce late graft injury and immune-driven complications, including late graft dysfunction, graft loss, chronic graft decline, and immune-mediated illness and death (such as severe infection, chronic rejection processes, or other immune-mediated conditions).
What is the practical deliverable or expected impact of CTOT-C?
The practical deliverable is better long-term transplant success in children, including improved durable graft survival, minimized treatment-related harm, and reduced mortality stemming from immune dysfunction, through evidence-based approaches informed by both clinical and mechanistic data.
Which NIH institute leads this program?
This NIH program is led by the National Institute of Allergy and Infectious Diseases (NIAID).
How is this grant opportunity classified?
This announcement is classified as a discretionary grant opportunity within the NIH health research activity area.
What CFDA numbers are associated with this funding opportunity?
The announcement lists CFDA numbers 93.855 (Allergy and Infectious Diseases Research) and 93.856 (Microbiology and Infectious Diseases Research).
What is the estimated total funding level for the opportunity?
The estimated total funding level is $4.3 million.
Is cost sharing or matching required?
No. The opportunity states there is no cost sharing or matching requirement.
Who is eligible to apply?
Eligibility is broad across U.S.-based organizations. Eligible applicants include public and private institutions of higher education, nonprofits (including those with and without 501(c)(3) status), small businesses, other for-profit organizations (other than small businesses), and a variety of government entities (state, county, city/township, special district governments, and independent school districts). The eligibility list also highlights community-based and faith-based organizations, eligible federal agencies, and a range of mission-focused institutions such as HBCUs, Hispanic-serving institutions, Alaska Native and Native Hawaiian-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), and tribal organizations and governments (including federally recognized tribal governments).
Are for-profit organizations eligible?
Yes. The eligibility description includes small businesses and other for-profit organizations (other than small businesses).
Are nonprofits without 501(c)(3) status eligible?
Yes. The eligibility language includes nonprofits with and without 501(c)(3) status.
Are tribal organizations and tribal governments eligible?
Yes. The eligibility list explicitly includes tribal organizations and governments, including federally recognized tribal governments, as well as Tribally Controlled Colleges and Universities (TCCUs).
Are non-U.S. (foreign) institutions eligible to apply as the primary applicant?
No. Non-U.S. entities (foreign institutions) are not eligible to apply as primary applicants.
Can international partners participate in some way?
Yes, in limited ways. The opportunity states that non-U.S. components of U.S. organizations may participate, and foreign components (as defined by NIH policy) are allowed. This enables certain international collaborations when tied to a U.S. applicant.
Is this opportunity intended for single-site projects or multi-site collaboration?
It is designed for institutions that can work together to run multi-site clinical research as part of a coordinated research consortium.
What is the focus area within transplantation?
The focus is pediatric solid organ transplantation, with an emphasis on improving long-term graft and patient outcomes through coordinated clinical studies and mechanistic investigations.
When was this opportunity posted and when did it close?
The opportunity was posted January 4, 2012, created January 26, 2012, with an original closing date of April 18, 2012, later extended to May 4, 2012. It was archived June 4, 2012.
Is this opportunity still active?
No. Based on the information provided, the opportunity was archived on June 4, 2012.
What is the overarching research strategy encouraged by this FOA?
The FOA encourages a combined approach: running rigorous pediatric transplant clinical trials and observational studies while simultaneously generating mechanistic (laboratory/translational) data to explain clinical outcomes and guide future therapies.
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