Opportunity Information: Apply for RFA HL 22 002
The Lung Transplant Consortium - Clinical Centers funding opportunity (RFA-HL-22-002) is a National Institutes of Health cooperative agreement (U01) meant to build a coordinated, multi-site consortium of high-volume lung transplant clinical centers. The central goal is to support observational and complementary mechanistic clinical research that explains how differences in real-world transplant decision-making and management across centers influence two big areas: how often donor lungs are used (donor lung utilization) and what happens to patients early after transplant. The FOA is explicitly not for clinical trials; instead, it is designed around systematically capturing clinical practice variation, outcomes, and biospecimens, then using those resources to answer hypothesis-driven questions.
A key scientific emphasis is on early post-transplant complications that remain major causes of illness and worse outcomes after lung transplantation, especially primary graft dysfunction (PGD) and acute lung allograft dysfunction (ALAD). Applicants are expected to focus on how site-specific selection criteria (for donors and/or recipients) and clinical management strategies (perioperative and early post-operative care, preservation approaches, immunosuppression practices, ventilation strategies, and other center-level protocols) may contribute to differences in donor lung acceptance and short-term outcomes. The program is built to compare and learn from these variations rather than impose a single practice model, with the idea that better evidence could ultimately guide more effective, safer, and more consistent transplant care.
To be competitive and eligible as a Clinical Center (CC), each application must be organized as a multidisciplinary effort and must include, at minimum, both a lung transplant surgeon and a lung transplant pulmonologist as part of the investigative leadership. The FOA also sets a scale requirement: the proposed CC structure must include a primary site plus any subsites that together perform at least 100 lung transplants annually. This volume threshold signals that the consortium is intended to generate robust, generalizable data quickly, and that participating sites must be able to reliably enroll participants and contribute meaningful numbers of cases and biospecimens.
From a project design standpoint, each CC application is expected to propose clear, hypothesis-driven research questions tied to donor and/or recipient practices and their relationship to outcomes like donor lung utilization, PGD, ALAD, or other relevant short-term endpoints. Importantly, the questions must be answerable using observational approaches and/or through biospecimen collection and analysis performed at the participating sites. In other words, the FOA is looking for rigorous clinical research that can leverage prospective and/or systematically collected clinical data, paired where appropriate with mechanistic measurements from blood, airway samples, tissue, or other biospecimens, without introducing interventional trial components.
Beyond each center’s local research aims, the consortium structure requires substantial coordination across all funded CCs. Awardees will be expected to enroll participants under a common research protocol and to contribute to a standardized core dataset and a core set of biospecimens that will be collected consistently across consortium sites. Oversight and harmonization will occur through a centralized Data Coordinating Center (DCC) and a Steering Committee (SC). This shared infrastructure is meant to produce a longitudinal resource that goes beyond any single center’s project, allowing investigators across the consortium to pursue additional high-value questions over time, including questions that may emerge only after enough standardized data and samples have been accumulated.
This FOA runs alongside a companion funding announcement for the Lung Transplant Consortium Data Coordinating Center (RFA-HL-22-003). Functionally, that means the Clinical Centers are not expected to independently build the full coordinating infrastructure; instead, they plug into a centrally managed system for data standards, participant tracking, quality control, biospecimen governance, and cross-site analyses, while still maintaining strong on-the-ground enrollment and sample collection capabilities.
In terms of who can apply, eligibility is broad and includes many standard U.S. organizational categories such as state and local governments, public and private institutions of higher education, nonprofits (with or without 501(c)(3) status), for-profit organizations (other than small businesses), and small businesses, as well as federally recognized tribal governments and other tribal organizations. The FOA also highlights additional eligible applicant types, including Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, faith-based or community-based organizations, U.S. territories or possessions, and even non-U.S. entities (foreign organizations), reflecting an intent to enable broad participation so long as the applicant can meet the clinical center and volume requirements.
Administratively, this is a discretionary funding opportunity using the cooperative agreement mechanism, which typically means NIH will have substantial programmatic involvement compared with a standard research grant. The CFDA number listed is 93.838 (heart, lung, and blood research). The opportunity’s original closing date is shown as 2021-06-15, and the listed award ceiling is $275,000. The announcement was created on 2021-02-25. Taken together, the FOA is essentially building a coordinated clinical research network where high-volume transplant centers contribute standardized data and biospecimens, enabling the field to more clearly identify which donor/recipient selection and early management practices lead to better utilization of scarce donor lungs and fewer early complications after lung transplantation.Apply for RFA HL 22 002
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Lung Transplant Consortium - Clinical Centers (U01 - Clinical Trial Not Allowed)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.838.
- This funding opportunity was created on 2021-02-25.
- Applicants must submit their applications by 2021-06-15. (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 $275,000.00 in funding.
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.
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FAQs: Lung Transplant Consortium - Clinical Centers (RFA-HL-22-002)
What is RFA-HL-22-002 funding?
RFA-HL-22-002 is a National Institutes of Health (NIH) cooperative agreement (U01) funding opportunity to build a coordinated, multi-site consortium of high-volume lung transplant clinical centers. The focus is on observational and complementary mechanistic clinical research related to real-world lung transplant decision-making and early outcomes.
What is the main purpose of this funding opportunity?
The central goal is to explain how differences in real-world transplant decision-making and management across centers influence (1) donor lung utilization (how often donor lungs are used) and (2) early post-transplant outcomes in recipients.
Is this opportunity intended to support clinical trials?
No. The FOA is explicitly not for clinical trials. It is designed to systematically capture clinical practice variation, outcomes, and biospecimens and use those resources to answer hypothesis-driven research questions without adding interventional trial components.
What types of research are expected under this FOA?
Applications are expected to propose hypothesis-driven questions that can be answered using observational approaches and/or biospecimen collection and analysis performed at participating sites. The work is expected to leverage prospectively and/or systematically collected clinical data, paired where appropriate with mechanistic measurements.
What are the key scientific topics emphasized in this FOA?
A major emphasis is on early post-transplant complications that remain leading causes of morbidity and worse outcomes after lung transplantation, particularly primary graft dysfunction (PGD) and acute lung allograft dysfunction (ALAD).
What outcomes or endpoints does the FOA prioritize?
The FOA prioritizes outcomes tied to donor lung utilization and early post-transplant endpoints, including PGD and ALAD, as well as other relevant short-term outcomes after transplant.
What kinds of center-level differences is the consortium meant to study?
The consortium is designed to evaluate how variation across centers may affect donor lung acceptance and early outcomes. Examples named in the FOA include differences in donor and/or recipient selection criteria and clinical management strategies such as perioperative and early post-operative care, preservation approaches, immunosuppression practices, ventilation strategies, and other center-level protocols.
Does the program require all sites to follow a single standardized clinical practice model?
No. The program is built to compare and learn from existing practice variations rather than impose a single practice model, with the longer-term aim of generating better evidence that could guide safer and more consistent transplant care.
What is required for a Clinical Center (CC) to be competitive and eligible?
Each Clinical Center application must be organized as a multidisciplinary effort and must include, at minimum, both a lung transplant surgeon and a lung transplant pulmonologist as part of the investigative leadership.
Is there a minimum lung transplant volume requirement to apply as a Clinical Center?
Yes. The proposed Clinical Center structure must include a primary site plus any subsites that together perform at least 100 lung transplants annually.
How can a program meet the annual volume threshold?
The FOA allows the volume requirement to be met through a structure that includes a primary site plus subsites, as long as the combined total across those sites is at least 100 lung transplants per year.
Why does the FOA emphasize high-volume centers?
The stated intent is to generate robust, generalizable data quickly and to ensure that participating sites can reliably enroll participants and contribute meaningful numbers of cases and biospecimens.
What must a Clinical Center propose in its research plan?
Each Clinical Center is expected to propose clear, hypothesis-driven research questions tied to donor and/or recipient practices and their relationship to outcomes such as donor lung utilization, PGD, ALAD, or other relevant short-term endpoints, and the questions must be answerable through observational data and/or biospecimen-based analyses conducted at participating sites.
What kinds of biospecimens are contemplated in this FOA?
The FOA anticipates collection and analysis of biospecimens such as blood, airway samples, tissue, or other biospecimens, as appropriate to address mechanistic questions.
Will Clinical Centers operate under a shared protocol across sites?
Yes. Awardees are expected to enroll participants under a common research protocol and contribute to a standardized core dataset and a core set of biospecimens collected consistently across consortium sites.
What consortium-wide governance or coordination structures are mentioned?
Oversight and harmonization are expected through a centralized Data Coordinating Center (DCC) and a Steering Committee (SC). This shared infrastructure supports data standards, participant tracking, quality control, biospecimen governance, and cross-site analyses.
What is the role of the Data Coordinating Center (DCC) relative to the Clinical Centers?
The FOA indicates that Clinical Centers are not expected to independently build the full coordinating infrastructure. Instead, they will plug into a centrally managed system operated through the DCC for functions such as data standards, tracking, quality control, biospecimen governance, and cross-site analyses.
Is there a related funding announcement for the Data Coordinating Center?
Yes. This FOA runs alongside a companion funding announcement for the Lung Transplant Consortium Data Coordinating Center: RFA-HL-22-003.
What long-term resource is this consortium intended to create?
The consortium is intended to create a longitudinal resource of standardized clinical data and biospecimens that extends beyond any one center, enabling additional high-value questions to be pursued over time, including questions that may emerge only after sufficient harmonized data and samples have accumulated.
What type of funding mechanism is used?
This is a discretionary funding opportunity using the NIH cooperative agreement mechanism (U01), which typically involves substantial NIH programmatic involvement compared with a standard research grant.
Who is eligible to apply?
Eligibility is broad and includes state and local governments, public and private institutions of higher education, nonprofits (with or without 501(c)(3) status), for-profit organizations (other than small businesses), small businesses, federally recognized tribal governments, and other tribal organizations. The FOA also highlights Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, faith-based or community-based organizations, U.S. territories or possessions, and non-U.S. entities (foreign organizations).
Does broad organizational eligibility remove the Clinical Center requirements?
No. While many organization types are eligible to apply, the application still needs to meet the Clinical Center expectations described in the FOA, including multidisciplinary leadership and the minimum annual transplant volume across a primary site and subsites.
What CFDA number is associated with this opportunity?
The CFDA number listed for this opportunity is 93.838 (heart, lung, and blood research).
What are the key administrative dates provided?
The announcement was created on 2021-02-25, and the opportunity lists an original closing date of 2021-06-15.
What is the listed award ceiling?
The listed award ceiling is $275,000.
In one sentence, what is this FOA trying to accomplish?
It is building a coordinated clinical research network where high-volume lung transplant centers contribute standardized data and biospecimens so the field can better identify which donor/recipient selection and early management practices improve donor lung utilization and reduce early complications after lung transplantation.
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