Opportunity Information: Apply for RFA AA 24 005
This funding opportunity (RFA-AA-24-005) is a limited competition Notice of Funding Opportunity from the National Institutes of Health (NIH), specifically tied to the National Institute on Alcohol Abuse and Alcoholism (NIAAA). It uses a cooperative agreement mechanism (U24), meaning the awardee is expected to work closely with NIH staff and the broader research network rather than operating fully independently. The goal is to fund a single Data Coordinating Center (DCC) that will support the next phase of the Alcohol-associated Hepatitis Clinical and Translational Network, referred to as the Alcohol-associated Hepatitis Network (AlcHepNet). AlcHepNet has been supported by NIAAA since 2012 and was renewed in 2018, and this NOFO continues that trajectory by focusing on coordinated, late-phase clinical research intended to improve outcomes for people with advanced alcohol-associated liver disease.
The program is structured around a network model. In the upcoming cycle, AlcHepNet is expected to include up to six Clinical Study Sites plus one centralized DCC. Together, they will carry out an integrated treatment clinical trial that explicitly combines treatment for alcohol use disorder (AUD) with treatment of liver disease. The patient populations highlighted for this integrated trial are those with severe alcohol-associated hepatitis (sAH) and those with decompensated alcohol-associated cirrhosis (deAC). The intent is not just to evaluate liver-focused interventions in isolation, but to test approaches that address ongoing alcohol use and addiction treatment as an essential part of improving liver-related and overall health outcomes, including biomedical measures, psychosocial functioning, and quality of life.
The core purpose of the DCC under this U24 is to provide the technical and operational backbone for the network's common-protocol clinical trial as well as to support ancillary studies conducted by individual sites. In practical terms, the DCC is expected to deliver expertise and infrastructure for data management (such as developing and maintaining databases and data pipelines, ensuring data quality, and supporting standardized data collection across sites), statistical analysis (including trial design support, interim and final analyses, and harmonized analytic methods), biospecimen collection coordination (helping standardize procedures and tracking for biologic samples gathered across the network), and broad logistical support. Because this is a cooperative agreement and a network program, the DCC role is fundamentally collaborative: it enables consistent execution across multiple clinical sites, reduces variability in how data and samples are collected and handled, and supports reliable cross-site analyses that can inform clinical practice for these high-risk patient groups.
Eligibility is broad across many U.S.-based organization types commonly allowed for NIH discretionary health funding (CFDA 93.273), including various levels of government (state, county, city/township, special districts), public and private institutions of higher education, federally recognized Native American tribal governments, tribal organizations, public housing authorities/Indian housing authorities, nonprofits (both 501(c)(3) and non-501(c)(3)), for-profit organizations (excluding small businesses in one category but also listing small businesses separately), and other eligible entities. The NOFO also calls out specific categories such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, regional organizations, and U.S. territories or possessions. At the same time, it clearly restricts foreign involvement: non-U.S. entities are not eligible to apply, non-domestic components of U.S. organizations are not eligible, and foreign components (as NIH defines them) are not allowed. In other words, the funded DCC and its activities must be fully domestic.
The opportunity was posted with a creation date of March 6, 2024, and an original application closing date of April 24, 2024. The NOFO does not provide an award ceiling or expected number of awards in the summary data provided, but by design it is oriented toward funding the single DCC function for the network. Overall, the grant is aimed at ensuring AlcHepNet has a centralized, expert hub to run a complex, multi-site clinical trial and related studies focused on integrating AUD treatment with liver disease care for patients facing severe alcohol-associated hepatitis and decompensated alcohol-associated cirrhosis.Apply for RFA AA 24 005
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Limited Competition: Alcohol-associated Hepatitis Clinical Network Integrated Treatment Clinical Trials Data Coordinating Center (U24 - Clinical Trial Required)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.273.
- This funding opportunity was created on 2024-03-06.
- Applicants must submit their applications by 2024-04-24. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- 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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Frequently Asked Questions (FAQs) - RFA-AA-24-005 (AlcHepNet Data Coordinating Center)
What is RFA-AA-24-005?
RFA-AA-24-005 is a limited competition Notice of Funding Opportunity (NOFO) from the National Institutes of Health (NIH), tied to the National Institute on Alcohol Abuse and Alcoholism (NIAAA). It supports the Alcohol-associated Hepatitis Clinical and Translational Network, referred to as the Alcohol-associated Hepatitis Network (AlcHepNet), by funding a single Data Coordinating Center (DCC) for the next phase of the network.
Which NIH institute is sponsoring this opportunity?
This opportunity is sponsored by NIH through the National Institute on Alcohol Abuse and Alcoholism (NIAAA).
What type of award mechanism is used?
The award mechanism is a cooperative agreement (U24). Under a cooperative agreement, the awardee is expected to work closely with NIH staff and the broader research network rather than operating fully independently.
What is the main goal of this funding opportunity?
The main goal is to fund one centralized Data Coordinating Center (DCC) that provides the technical, statistical, data, biospecimen coordination, and operational backbone for AlcHepNet's next phase of coordinated, late-phase clinical research.
How many awards are expected under this NOFO?
Based on the structure described, the NOFO is oriented toward funding a single DCC for the network. The summary information provided does not list an expected number of awards, but the program design emphasizes one centralized DCC.
Does the NOFO list an award ceiling?
No. The summary information provided does not include an award ceiling.
What is AlcHepNet?
AlcHepNet is the Alcohol-associated Hepatitis Clinical and Translational Network (Alcohol-associated Hepatitis Network). It has been supported by NIAAA since 2012 and was renewed in 2018. This NOFO continues that trajectory by supporting the network's next phase.
What is the network structure for the upcoming cycle?
In the upcoming cycle, AlcHepNet is expected to include up to six Clinical Study Sites plus one centralized Data Coordinating Center (DCC).
What kind of study will the network conduct?
The network will carry out an integrated treatment clinical trial that explicitly combines treatment for alcohol use disorder (AUD) with treatment of liver disease.
Which patient populations are highlighted for the integrated trial?
The highlighted patient populations are people with severe alcohol-associated hepatitis (sAH) and people with decompensated alcohol-associated cirrhosis (deAC).
Why does the clinical trial integrate AUD treatment with liver disease treatment?
The intent is to test approaches that do not treat liver-focused interventions in isolation, but instead address ongoing alcohol use and addiction treatment as an essential part of improving outcomes. The outcomes of interest include liver-related and overall health outcomes, biomedical measures, psychosocial functioning, and quality of life.
What is the role of the Data Coordinating Center (DCC) in this program?
The DCC is intended to serve as the centralized hub that supports consistent execution of the network's common-protocol clinical trial across multiple clinical sites and also supports ancillary studies conducted by individual sites.
What data management responsibilities are expected of the DCC?
The DCC is expected to provide expertise and infrastructure for data management, including developing and maintaining databases and data pipelines, ensuring data quality, and supporting standardized data collection across sites.
What statistical responsibilities are expected of the DCC?
The DCC is expected to support statistical analysis functions, including trial design support, interim analyses, final analyses, and harmonized analytic methods across the network.
What biospecimen coordination responsibilities are expected of the DCC?
The DCC is expected to help coordinate biospecimen collection by standardizing procedures and tracking biologic samples collected across the network.
What other types of support is the DCC expected to provide?
In addition to data, statistics, and biospecimens, the DCC is expected to provide broad logistical and operational support needed to run a complex, multi-site clinical trial and related studies within a network model.
How does the DCC help a multi-site network trial?
The DCC enables consistent execution across clinical sites, reduces variability in how data and samples are collected and handled, and supports reliable cross-site analyses that can inform clinical practice for high-risk patient groups.
Is this opportunity limited competition?
Yes. The NOFO is described as a limited competition funding opportunity.
Who is eligible to apply?
Eligibility is broad across many U.S.-based organization types commonly allowed for NIH discretionary health funding (CFDA 93.273). Examples listed include various levels of government (state, county, city/township, special districts), public and private institutions of higher education, federally recognized Native American tribal governments, tribal organizations, public housing authorities/Indian housing authorities, nonprofits (501(c)(3) and non-501(c)(3)), for-profit organizations, small businesses (listed separately), and other eligible entities.
Are minority-serving institutions and community-based organizations included in the eligible categories?
Yes. The NOFO specifically calls out categories such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), and faith-based or community-based organizations, as well as regional organizations and U.S. territories or possessions.
Are foreign organizations eligible to apply?
No. Non-U.S. entities are not eligible to apply.
Can a U.S. organization include a non-domestic component on this award?
No. Non-domestic components of U.S. organizations are not eligible.
Are foreign components allowed in any form?
No. Foreign components (as NIH defines them) are not allowed. The DCC and its activities must be fully domestic.
What is the CFDA (assistance listing) number associated with this opportunity?
The opportunity references CFDA 93.273 for NIH discretionary health funding.
When was this opportunity posted?
The creation (posting) date provided is March 6, 2024.
What was the original application closing date?
The original application closing date provided is April 24, 2024.
What is the overarching focus of the research supported by this DCC?
The overarching focus is coordinated, late-phase clinical research intended to improve outcomes for people with advanced alcohol-associated liver disease, specifically through an integrated model that combines AUD treatment with liver disease care.
Does the DCC support only the common-protocol trial, or also other studies?
The DCC is intended to support both the network's common-protocol clinical trial and ancillary studies conducted by individual clinical study sites.
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