The National Institute on Alcohol Abuse and Alcoholism (NIAAA) is offering this limited competition grant to support the Data Coordinating Center (DCC) for the Alcohol-associated Hepatitis Network (AlcHepNet). This grant is for the purpose of advancing the existing program, which has improved biomedical, psychosocial, and quality of life outcomes for patients with advanced alcohol-associated liver disease. The upcoming AlcHepNet cycle will involve up to six Clinical Study Sites and the DCC to conduct an integrated clinical trial. This trial will target severe alcohol-associated hepatitis and decompensated alcohol-associated cirrhosis, incorporating active treatment of Alcohol Use Disorder with liver disease treatment. The selected DCC will provide essential expertise in data management, statistical analysis, biospecimen collection, and logistical support for network-wide common protocols and ancillary studies.
Opportunity ID: 352844
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-AA-24-005 |
| Funding Opportunity Title: | Limited Competition: Alcohol-associated Hepatitis Clinical Network Integrated Treatment Clinical Trials Data Coordinating Center (U24 – Clinical Trial Required) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.273 — Alcohol Research Programs |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Mar 06, 2024 |
| Last Updated Date: | Mar 06, 2024 |
| Original Closing Date for Applications: | Apr 24, 2024 |
| Current Closing Date for Applications: | Apr 24, 2024 |
| Archive Date: | May 30, 2024 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Independent school districts State governments Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) For profit organizations other than small businesses Special district governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses Others (see text field entitled “Additional Information on Eligibility” for clarification) Native American tribal governments (Federally recognized) City or township governments Private institutions of higher education County governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled institutions of higher education |
| Additional Information on Eligibility: | 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. |
Additional Information
| Agency Name: | National Institutes of Health |
| 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. |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/rfa-files/RFA-AA-24-005.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH Grants Information
grantsinfo@nih.gov Email:grantsinfo@nih.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
Folder 352844 Full Announcement-RFA-AA-24-005 -> RFA-AA-24-005-Full-Announcement.pdf
Packages
| Agency Contact Information: | NIH Grants Information grantsinfo@nih.gov Email: grantsinfo@nih.gov |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| FORMS-H | Use for due dates on or after January 25, 2023 | PKG00285238 | Mar 22, 2024 | Apr 24, 2024 | View |
Package 1
Mandatory forms
352844 RR_SF424_5_0-5.0.pdf
352844 PHS398_CoverPageSupplement_5_0-5.0.pdf
352844 RR_OtherProjectInfo_1_4-1.4.pdf
352844 PerformanceSite_4_0-4.0.pdf
352844 RR_KeyPersonExpanded_4_0-4.0.pdf
352844 RR_Budget_3_0-3.0.pdf
352844 PHS398_ResearchPlan_5_0-5.0.pdf
352844 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
352844 RR_SubawardBudget30_3_0-3.0.pdf
352844 PHS_AssignmentRequestForm_3_0-3.0.pdf