Opportunity Information: Apply for RFA DK 09 003
Apply for RFA DK 09 003
- The National Institutes of Health in the food and nutrition health sector is offering a public funding opportunity titled "Adult to Adult Living Donor Liver Transplantation Cohort Study (A2ALL) (U01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.847 Diabetes, Digestive, and Kidney Diseases Extramural Research.
- This funding opportunity was created on Dec 12, 2008 and posted on Dec 12, 2008.
- Applicants must submit their applications by Mar 19, 2009. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $250,000.00 in funding.
- Eligible applicants include: Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses Native American tribal governments (Federally recognized) Small businesses County governments Others (see text field entitled Additional Information on Eligibility for clarification) Public housing authorities/Indian housing authorities Independent school districts Private institutions of higher education City or township governments Special district governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) State governments.
- 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 Foreign institutions must be located within North America
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Opportunity Summary:
The Adult to Adult Living Donor Liver Transplantation Cohort Study (A2ALL) (U01) funding opportunity (RFA DK 09 003) is a National Institutes of Health cooperative agreement announcement issued by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) to support the continuation of a major clinical research network focused on adult-to-adult living donor liver transplantation (LDLT). The core aim is to generate strong, real-world evidence on both the near-term and long-term outcomes of LDLT for two groups that matter most in this procedure: the living donors who undergo surgery without direct medical benefit to themselves, and the transplant recipients whose survival and quality of life depend on the transplant. Beyond clinical outcomes, the study is also positioned to deepen scientific understanding of liver regeneration and other biological processes that can be uniquely examined in the setting of partial liver donation and regrowth.
The program is designed as a coordinated network rather than a single-center project. NIH plans to fund up to nine clinical transplant centers (TCs) plus one centralized data coordinating center (DCC). The transplant centers would be responsible for enrolling and following donors and recipients, collecting standardized clinical data, and implementing common research protocols. The data coordinating center would serve as the hub for data management and quality control, statistical analysis, and cross-site coordination so that findings are comparable across institutions and can be combined into a single, rigorous cohort. This structure is meant to support large-scale, multi-site cohort research where consistent methods, shared governance, and centralized analytics are essential for credible results.
The award uses the NIH Cooperative Agreement (U01) mechanism, which signals that the NIH will have substantial programmatic involvement compared with a traditional investigator-initiated grant. In practical terms, applicants should expect an active partnership with NIDDK staff in areas such as study governance, protocol development or refinement, performance monitoring, and network-wide decision-making. The goal of that cooperative structure is to keep the network aligned around shared milestones, common data standards, and a cohesive scientific agenda that can reliably answer complex questions about LDLT outcomes and biology.
From a funding standpoint, NIDDK anticipated a total program budget of about $3.5 million through this announcement, with an expected set of awards covering the clinical sites and the single DCC. The listed award ceiling is $250,000 (as provided in the source data). The opportunity does not require cost sharing or matching, which lowers barriers for participation and helps ensure that scientific and clinical capability, rather than institutional ability to contribute matching funds, drives competitiveness.
Eligibility is broad and intentionally inclusive. Applications were welcomed from a wide range of organization types, including public and private institutions of higher education, nonprofit organizations (including both 501(c)(3) and non-501(c)(3)), for-profit organizations (including small businesses), state and local governments, tribal governments and tribal organizations, public housing authorities, independent school districts, and various special district and regional entities. The eligibility language also explicitly includes institutions such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian-serving institutions, and faith-based or community-based organizations. Foreign institutions were permitted only if located within North America. Importantly, the announcement emphasizes that participation is not limited to the centers already involved in A2ALL, meaning new transplant programs and coordinating groups could compete to join or lead components of the next phase.
Key dates included a posting and creation date of December 12, 2008, with an original and current closing date of March 19, 2009, and an archive date of April 19, 2009. The opportunity is categorized as discretionary funding, with the activity category listed under health (and tagged in the source record with food and nutrition/health categorization) and is associated with CFDA 93.847 (Diabetes, Digestive, and Kidney Diseases Extramural Research).
In summary, this FOA sought to sustain and expand a national, multi-center LDLT cohort infrastructure capable of answering high-impact questions about donor safety, recipient outcomes, and liver regeneration through a tightly coordinated NIH-supported network. The deliverable implied by the structure is not just individual site studies, but a unified, high-quality cohort dataset and collaborative research output that can guide clinical practice, inform patient counseling and risk assessment, and advance the biological science that is uniquely accessible through living donor liver transplantation.
Frequently Asked Questions (FAQs)
What is the A2ALL (U01) funding opportunity?
The Adult to Adult Living Donor Liver Transplantation Cohort Study (A2ALL) (U01) funding opportunity (RFA DK 09 003) is a National Institutes of Health (NIH) cooperative agreement announcement issued by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). It supports continuation of a major clinical research network focused on adult-to-adult living donor liver transplantation (LDLT).
What is the main purpose of this program?
The core purpose is to generate strong, real-world evidence on near-term and long-term outcomes of adult-to-adult LDLT for two key groups: (1) living donors, who undergo surgery without direct medical benefit to themselves, and (2) transplant recipients, whose survival and quality of life depend on the transplant.
What kinds of research questions is the program designed to answer?
Based on the description, the network is designed to evaluate donor safety and outcomes, recipient outcomes, and broader clinical impacts of LDLT over time. It is also positioned to deepen scientific understanding of liver regeneration and related biological processes that can be examined in the setting of partial liver donation and regrowth.
Is this intended to be a single-site study or a multi-site network?
This program is structured as a coordinated, multi-site clinical research network rather than a single-center project.
How many awards did NIH plan to make under this announcement?
NIH planned to fund up to nine clinical transplant centers (TCs) plus one centralized data coordinating center (DCC).
What is the role of the clinical transplant centers (TCs)?
The transplant centers would be responsible for enrolling and following living donors and transplant recipients, collecting standardized clinical data, and implementing common research protocols across sites.
What is the role of the data coordinating center (DCC)?
The DCC would function as the central hub for data management and quality control, statistical analysis, and cross-site coordination. This centralized approach is intended to ensure comparable findings across institutions and allow data to be combined into a single, rigorous cohort.
Why is a centralized coordinating center important for this study?
The opportunity emphasizes that large-scale, multi-site cohort research depends on consistent methods, shared governance, and centralized analytics. A centralized DCC supports data quality, standardization, and the ability to produce credible combined results across the network.
What funding mechanism is used for this opportunity?
The award uses the NIH Cooperative Agreement (U01) mechanism.
What does a U01 cooperative agreement imply about NIH involvement?
A U01 indicates substantial programmatic involvement by NIH compared with a traditional investigator-initiated grant. Applicants should expect active partnership with NIDDK staff in areas such as study governance, protocol development or refinement, performance monitoring, and network-wide decision-making.
How much total funding was anticipated for the program?
NIDDK anticipated a total program budget of about $3.5 million through this announcement to cover the expected set of awards across the clinical sites and the single DCC.
What is the listed award ceiling for this opportunity?
The listed award ceiling is $250,000 (as provided in the source data).
Is cost sharing or matching required?
No. The opportunity does not require cost sharing or matching.
Who is eligible to apply?
Eligibility is broad. Applications were welcomed from many organization types, including public and private institutions of higher education, nonprofit organizations (both 501(c)(3) and non-501(c)(3)), for-profit organizations (including small businesses), state and local governments, tribal governments and tribal organizations, public housing authorities, independent school districts, and various special district and regional entities.
Are minority-serving institutions and community-based organizations included in eligibility?
Yes. The eligibility language explicitly includes Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian-serving institutions, and faith-based or community-based organizations.
Are foreign institutions eligible?
Foreign institutions were permitted only if located within North America.
Is participation limited to centers already involved in A2ALL?
No. The announcement emphasizes that participation is not limited to centers already involved in A2ALL, meaning new transplant programs and coordinating groups could compete to join or lead components of the next phase.
What are the key dates for this funding opportunity?
Key dates included a posting and creation date of December 12, 2008; an original and current closing date of March 19, 2009; and an archive date of April 19, 2009.
How is this opportunity categorized?
The opportunity is categorized as discretionary funding, with the activity category listed under health (and tagged in the source record with food and nutrition/health categorization).
What CFDA number is associated with this opportunity?
This opportunity is associated with CFDA 93.847 (Diabetes, Digestive, and Kidney Diseases Extramural Research).
What are the expected deliverables or outputs implied by the network structure?
The structure implies deliverables beyond individual site studies, including a unified, high-quality cohort dataset and collaborative research output. The description highlights goals such as guiding clinical practice, informing patient counseling and risk assessment, and advancing biological science related to liver regeneration that is uniquely accessible through living donor liver transplantation.
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