The National Institute on Alcohol Abuse and Alcoholism (NIAAA) is offering this grant to advance clinical trials within the established Alcohol-associated Hepatitis Clinical and Translational Network (AlcHepNet). This limited competition opportunity seeks to fund up to six Clinical Study Sites and one Data Coordinating Center. The primary goal is to conduct an integrated clinical trial that simultaneously addresses Alcohol Use Disorder (AUD) and alcohol-associated liver disease (ALD), specifically targeting patients with severe alcohol-associated hepatitis (sAH) and decompensated alcohol-associated cirrhosis (deAC). Applicants for these U01 Collaborative Cooperative Agreements must propose an investigator-initiated common protocol and include a multidisciplinary team, comprising a hepatologist and an addiction medicine specialist, with a proven history of successful clinical trial enrollment.
Opportunity ID: 352842
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-AA-24-004 |
| Funding Opportunity Title: | Limited Competition: Alcohol-associated Hepatitis Clinical Network Integrated Treatment Clinical Trials Clinical Centers (U01-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: | Small businesses Others (see text field entitled “Additional Information on Eligibility” for clarification) For profit organizations other than small businesses Special district governments County governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) State governments Public housing authorities/Indian housing authorities Public and State controlled institutions of higher education Independent school districts City or township governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal governments (Federally recognized) |
| 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: | The purpose of this limited competition Notice of Funding Opportunity (NOFO) is to leverage the established clinical infrastructure 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 AlcHepNet, has been sponsored by the NIAAA since 2012 and was renewed in 2018. 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 Alcohol Use Disorder (AUD) with treatment of alcohol-associated liver disease (ALD). The targeted patient population will include severe alcohol-associated hepatitis (sAH) and decompensated alcohol-associated cirrhosis (deAC). Through this Request for Applications (RFA), U01 Collaborative Cooperative Agreement applications are sought to conduct an investigator-initiated common protocol integrated ALD-AUD treatment clinical trial and site-specific ancillary studies. Each Clinical Center application must consist of a multidisciplinary investigative team that includes a hepatologist and an addiction medicine specialist, and be comprised of primary and if necessary, subsites with a track record of successful enrollment in past clinical trials. |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/rfa-files/RFA-AA-24-004.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 352842 Full Announcement-RFA-AA-24-004 -> RFA-AA-24-004-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 | PKG00285236 | Mar 22, 2024 | Apr 24, 2024 | View |
Package 1
Mandatory forms
352842 RR_SF424_5_0-5.0.pdf
352842 PHS398_CoverPageSupplement_5_0-5.0.pdf
352842 RR_OtherProjectInfo_1_4-1.4.pdf
352842 PerformanceSite_4_0-4.0.pdf
352842 RR_KeyPersonExpanded_4_0-4.0.pdf
352842 PHS398_ResearchPlan_5_0-5.0.pdf
352842 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
352842 RR_Budget_3_0-3.0.pdf
352842 RR_SubawardBudget30_3_0-3.0.pdf
352842 PHS398_ModularBudget_1_2-1.2.pdf
352842 PHS_AssignmentRequestForm_3_0-3.0.pdf
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