Opportunity Information: Apply for RFA AI 09 015
Apply for RFA AI 09 015
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Coordinating Center for Organ Transplant Clinical Trials (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, Immunology and Transplantation Research 93.856 Microbiology and Infectious Diseases Research.
- This funding opportunity was created on Apr 2, 2009 and posted on Apr 2, 2009.
- Applicants must submit their applications by Jul 21, 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 $3,800,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $2,500,000.00 in funding.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: Native American tribal organizations (other than Federally recognized tribal governments) State governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments Independent school districts Small businesses Native American tribal governments (Federally recognized) Public and State controlled institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) Public housing authorities/Indian housing authorities Special district governments Private institutions of higher education County governments For profit organizations other than small businesses Nonprofits having a 501(c)(3) status with the IRS, other than 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.
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Opportunity Summary:
This funding opportunity, titled "Coordinating Center for Organ Transplant Clinical Trials (U01)" (Funding Opportunity Number RFA-AI-09-015), is a National Institutes of Health (NIH) grant announcement led by the National Institute of Allergy and Infectious Diseases (NIAID). The main goal is to support the renewal of a Statistical and Clinical Coordinating Center (SACCC) that serves as the central operational backbone for NIAID-sponsored organ transplantation research. In practical terms, the SACCC is expected to function as the hub that helps multiple clinical research networks run complex transplant studies consistently, safely, and in a way that produces reliable, analyzable data.
The coordinating center supported through this award is specifically intended to support clinical studies conducted by three NIAID-sponsored programs: the Clinical Trials in Organ Transplantation (CTOT) Consortium, the Clinical Trials in Organ Transplantation in Children (CTOT-C) Consortium, and the Genomics of Transplantation Cooperative Research Program (GTCRP). These groups represent adult transplant trials, pediatric transplant trials, and genomics-focused transplant research, respectively, and the SACCC is meant to provide shared infrastructure across them. The overall idea is that transplant trials often involve multiple sites, specialized protocols, high-risk patient populations, and intensive follow-up, so a dedicated center is needed to coordinate study operations and maintain high standards across all participating institutions.
The SACCC scope of work centers on three major responsibilities. First, it must provide statistical expertise, which typically includes designing analytic plans, supporting protocol development from a statistical perspective, guiding sample size and power calculations, developing randomization approaches when needed, and ensuring that study endpoints and interim analyses are handled appropriately. Second, it must manage data, meaning the SACCC is responsible for building and maintaining data systems, overseeing data collection and quality control, managing databases, and producing timely reports that allow investigators and NIAID to track study progress and data integrity. Third, it must provide clinical site monitoring, which generally involves ensuring that participating clinical sites follow the protocol, documenting compliance, verifying the accuracy of submitted data against source documents when required, and helping sites correct issues through training and corrective action processes.
A major emphasis of this opportunity is compliance. The SACCC will work closely with NIAID staff to ensure that supported studies comply with Good Clinical Practice (GCP) and with federal regulations governing human subjects research. This includes the kinds of operational and regulatory activities that are essential in clinical research, such as oversight of informed consent processes, adverse event reporting workflows, protocol deviation tracking, and the general documentation practices that allow an audit trail and demonstrate participant protections. Because the award uses a cooperative agreement mechanism, NIAID is not merely a passive funder; it expects substantial involvement with awardees in planning, oversight, and coordination, consistent with the U01 structure.
The funding mechanism is a Cooperative Agreement (U01), and the opportunity is categorized under discretionary funding in the health area. NIAID anticipated making one award. NIAID indicated it planned to commit about $3.8 million in fiscal year 2010 to support one new or competing renewal application under this announcement. The project period is five years. The budget guidance notes that direct costs, excluding consortium facilities and administrative (F&A) costs, are limited to roughly $2.0 to $2.5 million per year across the five-year period, signaling that NIAID expected an organization with significant coordinating-center capacity and experience, including the staffing and systems needed to support multiple concurrent transplant studies.
Eligibility is broad and includes many types of domestic organizations and governmental units. Eligible applicants listed include public and private institutions of higher education, nonprofit organizations (including 501(c)(3) and other nonprofits), for-profit organizations (including small businesses and other for-profits), state and local governments (such as county, city/township, special district governments), public housing authorities/Indian housing authorities, independent school districts, and Native American tribal governments and organizations (including federally recognized tribal governments and other tribal entities). The announcement also explicitly includes a range of mission-driven and historically underrepresented institution types and community-based organizations, such as Historically Black Colleges and Universities (HBCUs), Hispanic-Serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions. The opportunity does not require cost sharing or matching.
Key administrative details include a posted date of April 2, 2009, with an original and current closing date of July 21, 2009, and an archive date of August 21, 2009. The CFDA numbers associated with the opportunity are 93.855 (Allergy, Immunology and Transplantation Research) and 93.856 (Microbiology and Infectious Diseases Research), reflecting NIAID's portfolio areas that intersect with transplantation science, immunology, and infection risks in immunosuppressed patients. The full announcement was hosted through the NIH Grants Guide, and NIH provided contact direction through the NIH Office of Extramural Research (OER) webmaster emails for access and linking issues.
Taken together, this grant opportunity is essentially a five-year investment in the centralized statistical, data, and clinical operations infrastructure needed to run multicenter organ transplant clinical studies across adult, pediatric, and genomics-oriented programs. The successful applicant would be expected to demonstrate deep experience with multicenter clinical trials coordination, robust data management capabilities, strong biostatistical leadership, and a proven ability to monitor sites and maintain GCP and human-subject protections under close collaboration with NIAID through the U01 cooperative agreement structure.
Frequently Asked Questions (FAQs)
What is the title and funding opportunity number for this grant?
The opportunity is titled "Coordinating Center for Organ Transplant Clinical Trials (U01)" and the Funding Opportunity Number is RFA-AI-09-015.
Which agency and NIH institute are leading this funding opportunity?
This is a National Institutes of Health (NIH) funding opportunity led by the National Institute of Allergy and Infectious Diseases (NIAID).
What is the main purpose of this award?
The purpose is to support the renewal of a Statistical and Clinical Coordinating Center (SACCC) that serves as a centralized operational hub for NIAID-sponsored organ transplantation clinical research, helping studies run consistently, safely, and in a way that produces reliable, analyzable data.
What is the SACCC (Statistical and Clinical Coordinating Center)?
The SACCC is the central coordinating center expected to provide shared infrastructure and operational support across multiple NIAID-sponsored organ transplantation programs, including statistical support, data management, and clinical site monitoring.
Which NIAID-sponsored programs will the coordinating center support?
The coordinating center supported through this award is intended to support clinical studies conducted by: (1) the Clinical Trials in Organ Transplantation (CTOT) Consortium, (2) the Clinical Trials in Organ Transplantation in Children (CTOT-C) Consortium, and (3) the Genomics of Transplantation Cooperative Research Program (GTCRP).
What kinds of research do CTOT, CTOT-C, and GTCRP represent?
CTOT focuses on adult transplant clinical trials, CTOT-C focuses on pediatric transplant clinical trials, and GTCRP focuses on genomics-oriented transplantation research.
What are the three major areas of responsibility for the SACCC?
The SACCC scope of work centers on: (1) statistical expertise, (2) data management, and (3) clinical site monitoring.
What types of statistical activities are expected from the SACCC?
Expected statistical activities include supporting protocol development from a statistical perspective, developing analytic plans, guiding sample size and power calculations, developing randomization approaches when needed, and ensuring endpoints and interim analyses are handled appropriately.
What data management responsibilities are included in the SACCC scope?
The SACCC is responsible for building and maintaining data systems, overseeing data collection and quality control, managing databases, and producing timely reports to help investigators and NIAID track progress and data integrity.
What does clinical site monitoring involve under this opportunity?
Clinical site monitoring generally involves ensuring sites follow protocols, documenting compliance, verifying accuracy of submitted data against source documents when required, and helping sites address issues through training and corrective action processes.
How important is compliance and human subjects protection in this award?
Compliance is a major emphasis. The SACCC is expected to work closely with NIAID staff to ensure supported studies comply with Good Clinical Practice (GCP) and federal regulations governing human subjects research.
What kinds of regulatory and operational compliance activities are referenced?
Examples include oversight of informed consent processes, adverse event reporting workflows, protocol deviation tracking, and maintaining documentation practices that support an audit trail and demonstrate participant protections.
What is the funding mechanism used for this opportunity?
The funding mechanism is a Cooperative Agreement (U01).
What does it mean that this is a cooperative agreement (U01)?
Under a U01 cooperative agreement, NIAID is expected to have substantial involvement in planning, oversight, and coordination with the awardee, rather than acting only as a passive funder.
How many awards did NIAID anticipate making?
NIAID anticipated making one award.
What level of funding did NIAID plan to commit for this award?
NIAID indicated it planned to commit about $3.8 million in fiscal year 2010 to support one new or competing renewal application under this announcement.
What is the project period for this grant?
The project period is five years.
What budget guidance is provided regarding direct costs?
Direct costs (excluding consortium facilities and administrative (F&A) costs) are limited to roughly $2.0 to $2.5 million per year across the five-year period.
What does the budget guidance suggest about the expected applicant capacity?
The guidance signals that NIAID expected an organization with significant coordinating-center capacity and experience, including staffing and systems to support multiple concurrent transplant studies.
Is cost sharing or matching required?
No. The opportunity does not require cost sharing or matching.
Who is eligible to apply?
Eligibility is broad and includes many types of domestic organizations and governmental units, including public and private institutions of higher education, nonprofit organizations (including 501(c)(3) and other nonprofits), for-profit organizations (including small businesses and other for-profits), and various state and local government entities.
Are tribal governments and tribal organizations eligible?
Yes. Eligible applicants include Native American tribal governments and organizations, including federally recognized tribal governments and other tribal entities.
Are community-based, faith-based, and regional organizations included as eligible applicants?
Yes. The announcement explicitly includes faith-based or community-based organizations and regional organizations among eligible applicants.
Are historically underrepresented and mission-driven institutions listed as eligible?
Yes. Examples explicitly included are Historically Black Colleges and Universities (HBCUs), Hispanic-Serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), and Alaska Native and Native Hawaiian Serving Institutions.
Are U.S. territories or possessions eligible to apply?
Yes. U.S. territories or possessions are included among eligible applicants.
Does the opportunity mention eligible federal agencies?
Yes. The eligibility list explicitly includes eligible federal agencies.
What are the key dates for this funding opportunity?
The posted date is April 2, 2009. The original and current closing date is July 21, 2009. The archive date is August 21, 2009.
What CFDA numbers are associated with this opportunity?
The CFDA numbers are 93.855 (Allergy, Immunology and Transplantation Research) and 93.856 (Microbiology and Infectious Diseases Research).
Where was the full announcement hosted?
The full announcement was hosted through the NIH Grants Guide.
Who is referenced for help with access or linking issues?
NIH provided contact direction through the NIH Office of Extramural Research (OER) webmaster emails for access and linking issues.
What overall need is this grant trying to address in organ transplantation research?
The opportunity reflects the need for centralized statistical, data, and clinical operations infrastructure to run complex multicenter organ transplant studies, including high-risk patient populations, specialized protocols, and intensive follow-up, across adult, pediatric, and genomics-oriented programs.
What kinds of capabilities would a strong applicant be expected to demonstrate?
Based on the description, the successful applicant would be expected to demonstrate deep experience with multicenter clinical trials coordination, robust data management capabilities, strong biostatistical leadership, and an ability to monitor sites and maintain GCP and human-subject protections while collaborating closely with NIAID under the U01 structure.
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