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Limited Competition: Alcohol-associated Hepatitis Clinical Network Integrated Treatment Clinical Trials Data Coordinating Center (U24 - Clinical Trial Required)

ID: RFA-AA-24-005 • Type: Posted
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Description

he purpose of this limited competition Notice of Funding Opportunity (NOFO) is to support the Data Coordinating Center of the previously funded program on Late Phase Clinical Trials and Observational Studies in Alcoholic Hepatitis. The existing program of AH Clinical and Translational Network, hereafter termed Alcohol-associated Hepatitis Network, AlcHepNet, has been sponsored by the NIAAA since 2012 and was renewed in 2018. The purpose of this research program is to improve biomedical, psychosocial and quality of life outcomes for patients with advanced alcohol-associated liver disease. In the next cycle the program will consist of up to six Clinical Study Sites and one Data Coordinating Center to conduct an integrated treatment clinical trial that incorporates active treatment of AUD with treatment of liver disease. The targeted patient population will include severe alcohol-associated hepatitis (sAH) and decompensated alcohol-associated cirrhosis (deAC). Through this RFA, applications are sought for a Data Coordinating Center (DCC) to provide expert assistance to support the AlcHepNet network-wide common protocol clinical trial and local site ancillary studies on data management, statistical analysis, biospecimen collection, and logistical support under the U24 Resource-Related Research Projects Cooperative Agreements funding mechanism.
Background
The purpose of this limited competition Notice of Funding Opportunity (NOFO) is to support the Data Coordinating Center of the previously funded program on Late Phase Clinical Trials and Observational Studies in Alcoholic Hepatitis. The existing program of AH Clinical and Translational Network, hereafter termed Alcohol-associated Hepatitis Network, AlcHepNet, has been sponsored by the NIAAA since 2012 and was renewed in 2018. The purpose of this research program is to improve biomedical, psychosocial and quality of life outcomes for patients with advanced alcohol-associated liver disease.

Grant Details
In the next cycle, the program will consist of up to six Clinical Study Sites and one Data Coordinating Center to conduct an integrated treatment clinical trial that incorporates active treatment of AUD with treatment of liver disease. Through this RFA, applications are sought for a Data Coordinating Center (DCC) to provide expert assistance to support the AlcHepNet network-wide common protocol clinical trial and local site ancillary studies on data management, statistical analysis, biospecimen collection, and logistical support under the U24 Resource-Related Research Projects – Cooperative Agreements funding mechanism.

Eligibility Requirements
Only current AlcHepNet recipients funded through RFA-AA-18-004 are eligible to apply. Investigators with demonstrated experience in coordinating large multi-site clinical research studies and another senior investigator with extensive clinical research experience and expertise in the field of hepatology are recommended.

Period of Performance
The project period can be up to 5 years.

Grant Value
NIAAA intends to commit up to a combined $7 Million in total costs in FY 2024 to fund this RFA and the companion (RFA-AA-24-004). Application budget is limited to $2,550,000 direct costs in each year of the project period.
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Overview

Agency
National Institutes of Health (NIH) [HHS]
Category of Funding
Health
Funding Instruments
Cooperative Agreement
Grant Program (CFDA)
93.273 - Alcohol Research Programs
Grant Category
Discretionary
Cost Sharing / Matching Requirement
False
Source
Grants.gov
On 3/6/24 the National Institutes of Health posted grant opportunity RFA-AA-24-005 for Limited Competition: Alcohol-associated Hepatitis Clinical Network Integrated Treatment Clinical Trials Data Coordinating Center (U24 - Clinical Trial Required). The grant will be issued under grant program 93.273 Alcohol Research Programs.

Timing

Posted Date
March 6, 2024, 12:00 a.m. EST
Closing Date
April 24, 2024, 12:00 a.m. EDT Past Due
Last Updated
March 6, 2024, 3:11 p.m. EST
Version
1
Archive Date
May 30, 2024

Eligibility

Eligible Applicants
Others (see text field entitled "Additional Information on Eligibility" for clarification)
Native American tribal governments (Federally recognized)
Special district governments
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Independent school districts
State governments
City or township governments
Small businesses
For profit organizations other than small businesses
Public and State controlled institutions of higher education
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Public housing authorities/Indian housing authorities
Private institutions of higher education
Native American tribal organizations (other than Federally recognized tribal governments)
County governments
Additional Info
Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); 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); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Contacts

Contact
National Institutes of Health
Contact Email
grantsinfo@nih.gov
Email Description
See Section VII. Agency Contacts within the full opportunity announcement for all other inquires.
Contact Phone
(301) 402-2541
Additional Information
https://grants.nih.gov/grants/guide/rfa-files/RFA-AA-24-005.html
Additional Information Site
http://grants.nih.gov/grants/guide/rfa-files/RFA-AA-24-005.html

Documents

Posted documents for RFA-AA-24-005

Grant Awards

Grants awarded through RFA-AA-24-005

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