Single Source Renewal for the Continuation of the Liver Cirrhosis Network: Scientific and Data Coordination Center (U24 Clinical Trial Optional)

Q: When is the deadline for Single Source Renewal for the Continuation of the Liver Cirrhosis Network: Scientific and Data Coordination Center (U24 Clinical Trial Optional)?

The deadline is January 27, 2027.

National Institutes of Health

Federal Grants for Science Research

Apply Now

Funding Amount

Up to $1,850,000

Deadline

January 27, 2027

294 days left

Grant Type

federal

Overview

Single Source Renewal for the Continuation of the Liver Cirrhosis Network: Scientific and Data Coordination Center (U24 Clinical Trial Optional)

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH) of the U.S. Department of Health and Human Services is seeking a Single Source renewal application to continue scientific service as the Scientific and Data Coordination Center for the Liver Cirrhosis Network.The application will be peer-reviewed and if it is not a meritorious application, it will not be funded. This is a Notice of Funding Opportunity (NOFO) for a Single Source that will invite application(s) from eligible organization(s) to apply. Please see Section III. Eligibility for additional information. In accordance with NIH standard peer-review processes, the application(s) will be peer-reviewed, and only meritorious application(s) will be considered for funding.

Details

Agency: National Institutes of Health
Department: Department of Health and Human Services
Opportunity #: RFA-DK-26-309
Total Funding: $1,850,000
Expected Awards: 1
Instrument: cooperative_agreement

Eligibility

Refer to Section III. Eligibility Information within the NOFO for additional information on eligibility.Eligible OrganizationsOnly the following applicant is eligible to apply for this single source funding: Northwestern University. Please refer to Section I. Notice of Funding Opportunity Information for more details.Foreign Organizations/Foreign CollaborationsNon-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.

Eligibility

Eligible Applicant Types

other

How to Apply

RFA-DK-26-309-Full-Announcement.html

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<title>RFA-DK-26-309: Single Source Renewal for the Continuation of the Liver Cirrhosis Network: Scientific and Data Coordination Center (U24 Clinical Trial Optional)</title>

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<div id="page-title" class="heading1" tabindex="0">Department of Health and Human Services</div>

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<a id='_bookmark261373' tabindex='-1' aria-hidden='true'></a><a name="_Part 1. Overview Information"></a><h1>Part 1. Overview Information</h1>
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<a id='_bookmark261374' tabindex='-1' aria-hidden='true'></a>Participating Organization(s)
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<p>National Institutes of Health (<a href="http://www.nih.gov">NIH</a>)</p>
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<a id='_bookmark261376' tabindex='-1' aria-hidden='true'></a>Components of Participating Organizations
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<p>National Institute of Diabetes and Digestive and Kidney Diseases (<a href="https://www.niddk.nih.gov/" target="_blank" rel="noreferrer">NIDDK</a>)
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<a id='_bookmark261378' tabindex='-1' aria-hidden='true'></a>Funding Opportunity Title
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<span class="title">Single Source Renewal for the Continuation of the Liver Cirrhosis Network: Scientific and Data Coordination Center (U24 Clinical Trial Optional)</span>
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<div class="row" data-index="7">
<div class="col-md-4 datalabel" tabindex="0" data-element-id="261379" data-element-required="true" data-element-has-value="true" data-section-code="OI" data-element-type="TEXT">
<a id='_bookmark261379' tabindex='-1' aria-hidden='true'></a>Activity Code
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<div class=" col-md-8 datacolumn">
<p><a href="http://grants.nih.gov/grants/funding/ac_search_results.htm?text_curr=u24&Search.x=0&Search.y=0&sort=ac&Search_Type=Activity&text_prev=">U24</a> Resource-Related Research Projects – Cooperative Agreements</p>
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<a id='_bookmark261380' tabindex='-1' aria-hidden='true'></a>Announcement Type
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<div class=" col-md-8 datacolumn">
Reissue of

RFA-DK-20-004

<br/>
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<a id='_bookmark261381' tabindex='-1' aria-hidden='true'></a>Related Notices
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<div class=" col-md-8 datacolumn">
<ul><li>Check for any recent <a href="https://grants.nih.gov/grants/guide/url_redirect.php?id=11163">Notices of NIH Policy Changes</a> that may impact application requirements.</li></ul>
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<div class="col-md-4 datalabel" tabindex="0" data-element-id="261382" data-element-required="true" data-element-has-value="true" data-section-code="OI" data-element-type="LINKED_ELEMENT">
<a id='_bookmark261382' tabindex='-1' aria-hidden='true'></a>Funding Opportunity Number (FON)
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<div class=" col-md-8 datacolumn">
<span class="noticenum">RFA-DK-26-309</span>
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<div class="col-md-4 datalabel" tabindex="0" data-element-id="261383" data-element-required="true" data-element-has-value="true" data-section-code="OI" data-element-type="LINKED_ELEMENT">
<a id='_bookmark261383' tabindex='-1' aria-hidden='true'></a>Companion Funding Opportunity
</div>
<div class=" col-md-8 datacolumn">
<a href="https://www.grants.gov/search-results-detail/358910" target="_blank" rel="noreferrer">RFA-DK-26-308</a>

<span class="separator" style="position:relative;left:-3px">,</span> <a href="https://grants.nih.gov/grants/funding/ac_search_results.htm?text_curr=U01&&Search.x=0&&Search.y=0&&Search_Type=Activity" target="_blank" rel="noreferrer">U01</a>
Research Project (Cooperative Agreements)

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<div class="col-md-4 datalabel" tabindex="0" data-element-id="261384" data-element-required="true" data-element-has-value="true" data-section-code="OI" data-element-type="TEXT">
<a id='_bookmark261384' tabindex='-1' aria-hidden='true'></a>Number of Applications
</div>
<div class=" col-md-8 datacolumn">
<p>See Part 2, Section III. 3. Additional Information on Eligibility.</p>
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<a id='_bookmark261385' tabindex='-1' aria-hidden='true'></a>Assistance Listing Number(s)
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<div class=" col-md-8 datacolumn">
93.847
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<div class="col-md-4 datalabel" tabindex="0" data-element-id="261386" data-element-required="true" data-element-has-value="true" data-section-code="OI" data-element-type="TEXT">
<a id='_bookmark261386' tabindex='-1' aria-hidden='true'></a>Funding Opportunity Purpose
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<div class=" col-md-8 datacolumn">
<p>The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH) of the U.S. Department of Health and Human Services is seeking a Single Source renewal application to continue scientific service as the Scientific and Data Coordination Center for the Liver Cirrhosis Network. The application will be peer-reviewed and if it is not a meritorious application, it will not be funded.<br><br>This is a Notice of Funding Opportunity (NOFO) for a Single Source that will invite application(s) from eligible organization(s) to apply. Please see Section III. Eligibility for additional information. In accordance with NIH standard peer-review processes, the application(s) will be peer-reviewed, and only meritorious application(s) will be considered for funding.<br> </p>
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<a id='_bookmark261388' tabindex='-1' aria-hidden='true'></a>Funding Opportunity Goal(s)
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<div class=" col-md-8 datacolumn">
<p>The goals of the Liver Cirrhosis Network will be to complete enrollment in the Liver Cirrhosis Network Cohort; and in the Liver Cirrhosis Network Rosuvastatin Efficacy and Safety for Cirrhosis in the United States clinical studies.</p>
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<a id='_bookmark261389' tabindex='-1' aria-hidden='true'></a><a name="_Key Dates"></a><h2>Key Dates</h2>
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<a id='_bookmark261390' tabindex='-1' aria-hidden='true'></a>Posted Date
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January 09, 2026
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<a id='_bookmark261391' tabindex='-1' aria-hidden='true'></a>Open Date (Earliest Submission Date)
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January 09, 2026
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<th scope="col" colspan="3" style="border:2px solid #bcbcbc;" class="text-center">Application Due Dates</th>
<th scope="col" colspan="3" style="border:2px solid #bcbcbc;" class="text-center">Review and Award Cycles</th>
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<th scope="col" style="width:16.66%;border-left:2px solid #bcbcbc;" class="text-center">New</th>
<th scope="col" style="width:16.66%" class="text-center">Renewal / Resubmission / Revision (as allowed)</th>
<th scope="col" style="width:16.66%;border-right:2px solid #bcbcbc;" class="text-center">AIDS - New/Renewal/Resubmission/Revision, as allowed</th>
<th scope="col" style="width:16.66%" class="text-center">Scientific Merit Review</th>
<th scope="col" style="width:16.66%" class="text-center">Advisory Council Review</th>
<th scope="col" style="width:16.66%;border-right:2px solid #bcbcbc;" class="text-center">Earliest Start Date</th>
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<td>
Not Applicable
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February 09, 2026
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<td>
Not Applicable
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<td>July 2026</td>
<td> October 2026

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<td>December 2026</td>
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<td>
Not Applicable
</td>
<td>
January 27, 2027
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<td>
Not Applicable
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<td>July 2027</td>
<td> October 2027

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<td>December 2027</td>
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<a id='_bookmark261395' tabindex='-1' aria-hidden='true'></a><p>All applications are due by 5:00 PM local time of applicant organization. </p>

<p>Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.</p>
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<a id='_bookmark261401' tabindex='-1' aria-hidden='true'></a>Expiration Date
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January 28, 2027
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<a id='_bookmark261402' tabindex='-1' aria-hidden='true'></a>Due Dates for E.O. 12372
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<p>Not Applicable</p>
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<a id='_bookmark262221' tabindex='-1' aria-hidden='true'></a>Required Application Instructions
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<p>It is critical that applicants follow the instructions in the Research (R) Instructions in the <a href="https://grants.nih.gov/grants/guide/url_redirect.htm?id=82400">How to Apply - Application Guide</a>, except where instructed to do otherwise (in this NOFO or in a Notice from <a href="http://grants.nih.gov/grants/guide/url_redirect.htm?id=11164">NIH Guide for Grants and Contracts</a>).</p><p>Conformance to all requirements (both in the <a href="https://grants.nih.gov/grants/guide/url_redirect.htm?id=82400">How to Apply - Application Guide</a> and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the <a href="https://grants.nih.gov/grants/guide/url_redirect.htm?id=82400">How to Apply - Application Guide</a> as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the <a href="https://grants.nih.gov/grants/guide/url_redirect.htm?id=82400">How to Apply - Application Guide</a>, follow the program-specific instructions.</p><p><strong>Applications that do not comply with these instructions may be delayed or not accepted for review.</strong></p>
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<a id='_bookmark261403' tabindex='-1' aria-hidden='true'></a><p style="margin-left:0in;">There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You <strong>must</strong> use one of these submission options to access the application forms for this opportunity.</p><ol><li>Use the <a href="https://public.era.nih.gov/assist/landing.era?tabId=0819b5fc-46b7-4f02-b6b7-127e5a4e19fa">NIH ASSIST system</a> to prepare, submit and track your application online.</li><li>Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and <a href="https://public.era.nih.gov/commons/">eRA Commons</a> to track your application. Check with your institutional officials regarding availability.</li><li>Use <a href="https://grants.gov/search-grants?oppStatuses=closed|archived|posted|forecasted&fon=PA-25-301">Grants.gov</a> Workspace to prepare and submit your application and <a href="http://public.era.nih.gov/commons/">eRA Commons</a> to track your application.</li></ol>
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<div id="tocDiv">
<div class="heading1" tabindex="0">Table of Contents</div>
<div class="toc-link"><a href="#_Part1.OverviewInformation">Part 1. Overview Information</a></div><div class="toc-link P_SingleIndent"><a href="#_KeyDates">Key Dates</a></div><div class="toc-link"><a href="#_Part2.FullTextofAnnouncement">Part 2. Full Text of Announcement</a></div><div class="toc-link P_SingleIndent"><a href="#_SectionI.NoticeofFundingOpportunityDescription">Section I. Notice of Funding Opportunity Description</a></div><div class="toc-link P_SingleIndent"><a href="#_SectionII.AwardInformation">Section II. Award Information</a></div><div class="toc-link P_SingleIndent"><a href="#_SectionIII.EligibilityInformation">Section III. Eligibility Information</a></div><div class="toc-link P_SingleIndent"><a href="#_SectionIV.ApplicationandSubmissionInformation">Section IV. Application and Submission Information</a></div><div class="toc-link P_SingleIndent"><a href="#_SectionV.ApplicationReviewInformation">Section V. Application Review Information</a></div><div class="toc-link P_SingleIndent"><a href="#_SectionVI.AwardAdministrationInformation">Section VI. Award Administration Information</a></div><div class="toc-link P_SingleIndent"><a href="#_SectionVII.AgencyContacts">Section VII. Agency Contacts</a></div><div class="toc-link P_SingleIndent"><a href="#_SectionVIII.OtherInformation">Section VIII. Other Information</a></div>
</div><br/>

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<a id='_bookmark261405' tabindex='-1' aria-hidden='true'></a><a name="_Part 2. Full Text of Announcement"></a><h1>Part 2. Full Text of Announcement</h1>
</div>

<div data-element-id="261406" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="FOD" data-element-type="TEXT">
<a id='_bookmark261406' tabindex='-1' aria-hidden='true'></a><a name="_Section I. Notice of Funding Opportunity Description"></a><h2>Section I. Notice of Funding Opportunity Description</h2>
</div>

<div data-element-id="261407" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="FOD" data-element-type="TEXT">
<a id='_bookmark261407' tabindex='-1' aria-hidden='true'></a><p>Purpose:</p><p>This is a non-competitive funding opportunity intended to fund a single award. The National Institute of Diabetes and Digestive and Kidney Diseases is announcing its intent to issue a Single Source cooperative agreement award to Northwestern University for continuation of scientific services as the Scientific and Data Coordination Center for the Liver Cirrhosis Network. The application will be peer-reviewed and if it is not a meritorious application, it will not be funded.</p><p>Background:</p><p>Cirrhosis represents not a single disease, but rather the outcome of many chronic liver diseases, caused by a wide range of conditions.  The etiologies of cirrhosis in the United States include infectious causes such as chronic hepatitis B, C and D; genetic causes such as Wilson disease, hemochromatosis and alpha-1-antitrypsin deficiency; nutritional or metabolic causes such as nonalcoholic steatohepatitis (NASH also known as metabolic dysfunction associated steatohepatitis; MASH); autoimmunity such as autoimmune hepatitis, primary biliary cirrhosis and sclerosing cholangitis; and toxic causes such as alcoholic liver disease, and chronic liver injury from medications such as methotrexate and amiodarone.  Cirrhosis from these diseases is almost always the result of chronic injury with persistent inflammation and cell damage that results in faulty healing and fibrosis. As fibrosis accumulates it causes distortion of the architecture of liver, portal hypertension, and compromise of liver function.  Clinical complications of cirrhosis include symptoms (such as fatigue, weakness, weight loss, itching and jaundice), gastrointestinal bleeding from varices or portal hypertensive gastropathy, ascites and disturbance of fluid and electrolyte balance, renal dysfunction, and hepatic encephalopathy.  The most dreaded complication of cirrhosis is hepatocellular carcinoma, a highly fatal cancer that arises in 1 to 3% of persons with cirrhosis yearly.  Once cirrhosis is present, treatment of the underlying liver disease can slow or stop further progress, but it does not eliminate all risk of complications.</p><p>Mortality due to liver disease remains a significant public health burden in the United States, currently ranked as the 10<sup>th</sup> most common cause of death overall, and ranking 6th in persons below the age of 65 years.  The prevalence of cirrhosis appears to be rising in some populations, such as persons living with HIV infection, genetic immune deficiency disorders, and cystic fibrosis.  Hepatocellular carcinoma incidence is also rising in the United States and is a surrogate for the prevalence of cirrhosis.</p><p>Treatment of underlying chronic liver disease such as with antivirals for chronic hepatitis B and C; therapeutic phlebotomy for genetic hemochromatosis; ursodiol for primary biliary cirrhosis; weight loss for nonalcoholic steatohepatitis, and cessation of alcohol consumption for alcoholic liver disease, all are primarily aimed at prevention of cirrhosis by early abrogation of ongoing injury to the still noncirrhotic liver. Curing or ameliorating the liver disease may allow the injured liver to invoke endogenous mechanisms to reverse the consequences of chronic inflammation and the accumulation of mild or even moderate amounts of liver fibrosis.  However, once cirrhosis has been established, neutralization of the causes of liver disease generally will not reverse the cirrhosis.</p><p>Liver transplantation is currently the only medically viable avenue for patients with cirrhosis and end-stage liver disease that will extend longevity.  On an annual basis, despite treatment success rates for chronic hepatitis C and other liver diseases, the number of liver transplants done in the United States continues to increase, most recently rising above 10,000 per year. Of patients placed on the waiting list, at least 3000 patients become too ill to undergo transplantation or die while waiting for an organ each year.  However, it is important to emphasize that liver transplantation is an option for only 10% to20% of patients with end-stage liver disease and that the death rates from chronic liver disease and cirrhosis is more than 50,000 each year in the United States. This rate includes persons who were never placed upon a liver transplant list because they had comorbid conditions that did not allow transplant surgery or had social, psychological, or financial reasons for not qualifying for this serious and expensive option.</p><p>Given the discrepancy between the demand and the supply of organs for patients on liver transplant waiting lists and the even more numerous patients who are unable to be considered for listing for liver transplantation, there is a significant need to improve our understanding of clinical and translational scientific aspects of liver fibrosis and cirrhosis.  This includes improving the understanding of the underlying pro- and anti-fibrotic mechanisms as well as risk factors that accentuate pro- and anti-fibrotic processes and how can this knowledge improve clinical practice and the prevention of the serious complications of cirrhosis. </p><p>To address the public health burden of liver cirrhosis, the NIDDK established the Liver Cirrhosis Network (LCN) through RFA-DK-20-003 and RFA-DK-20-004.  The LCN subsequently conceived, developed and operationalized the Liver Cirrhosis Network Cohort Study (LCN Cohort <a href="https://clinicaltrials.gov/study/NCT05740358">NCT05740358</a>) a prospective study of the natural history of compensated cirrhosis due to its many known causes; and the Liver Cirrhosis Network Rosuvastatin Efficacy and Safety for Cirrhosis in the United States (LCN RESCU <a href="https://clinicaltrials.gov/study/NCT05832229">NCT05832229</a>) a randomized, double-blind, placebo-controlled Phase 2 clinical trial of rosuvastatin in patients with compensated cirrhosis due to its major causes.  The LCN Cohort Study is nearing the enrollment objective of 1200 participants while the LCN RESCU study has enrolled one third of the target enrollment. </p><p>Organization, Components, and Governance:</p><p>The Liver Cirrhosis Network will be administered under a Cooperative Agreement and be composed of Clinical Centers (CC), a single Scientific Data Coordination Center (SDCC), and the NIDDK and other components of the NIH as deemed appropriate by the NIDDK. The Liver Cirrhosis Network will be governed by a Steering Committee composed of investigators from each of the Clinical Centers, the Scientific Data Coordination Center, and the NIDDK and other components of the NIH as deemed appropriate by the NIDDK.  Other subcommittees, working groups, and task forces of the Steering Committee previously established by the LCN will be renewed, prioritized and operationalized as necessary, such as committees on publications, ancillary studies, protocols, pathology, biospecimen use, and radiology. An Executive Committee comprised of at a minimum the Network Chair and Vice-Chair who will be determined by the Steering Committee with NIDDK concurrence at the re-establishment of the Liver Cirrhosis Network; the Program Director/Principal Investigator of the SDCC; and the NIDDK Project  Scientist and Program Official; and other NIDDK personnel and other components of the NIH as deemed necessary by the NIDDK will be established to effect management decisions required between Steering Committee meetings, that is needed for efficient progress of the Network scientific activities.  An independent Data and Safety Monitoring Board (DSMB) has been established by the NIDDK and will be continued to review protocols and monitor patient safety and performance of each Network study.  As a part of its responsibilities, the DSMB will submit recommendations to the NIDDK regarding the continuation of each study. The DSMB will be responsible for final approval of the Data and Safety Monitoring Plan developed by the SDCC.  All protocols or changes to protocols will require to be approved by a central or single Institutional Review Board, the Steering Committee, the Liver Cirrhosis Network Data and Safety Monitoring Board, and the NIDDK before initiation.  Any specific collaboration involving the resources of the Liver Cirrhosis Network will require approval by the Steering Committee and the NIDDK Program Officer. Voting privileges for Steering Committee decisions will be by the Principal Investigator or designee of the grantees for the Clinical Centers, the Scientific Data Coordination Center, and the NIDDK and other components of the NIH as deemed appropriate by the NIDDK.  All face-to-face Steering Committee, DSMB, and other necessary face to face meetings requiring the presence of NIDDK and NIH personnel will be held in the Washington, DC/Baltimore metropolitan area or other suitable venue as appropriate for the operational efficiency of Network scientific activities and for the Programmatic oversight of cost-efficient Network resource management.</p><p>Clinical Centers will be responsible for operationalizing the LCN Cohort and LCN RESCU Studies. Additionally, Clinical Centers will be responsible for developing new protocol concepts conditional upon availability of Network resources, participating in their overall development, conducting the research, and disseminating research findings.  For each investigational or therapeutic protocol, one CC will take the lead responsibility in conjunction with a protocol development subcommittee for drafting the protocol, although the Steering Committee will provide input and will be responsible for assuring development of a common protocol to be implemented by all of the Liver Cirrhosis Network CCs.  The CC PD/PI leading the development of the protocol will also provide protocol oversight and management if implemented as a Liver Cirrhosis Network study.  All CC PDs/PIs will be strongly encouraged to fully commit their center resources and efforts to the Network protocols.  With the advent of electronic medical record (EMR) systems, it is desirable that CCs will be able to efficiently utilize their EMR for efficient screening of patient candidates for participation in the Liver Cirrhosis Network.</p><p>All individual CCs will be required to participate in a cooperative and interactive manner with one another, with the SDCC, and with the NIDDK and other components of the NIH in all aspects of the Liver Cirrhosis Network (see Terms and Conditions of Award). Only investigators who wish to carry out the protocols of the Liver Cirrhosis Network and agree to be governed by the policies and procedures of the Liver Cirrhosis Network and its Steering Committee should apply under this NOFO.</p><p>The SDCC will abide by the NIDDK Regulatory Policies and Guidance document at <a href="https://www.niddk.nih.gov/research-funding/human-subjects-research/policies-clinical-researchers">https://www.niddk.nih.gov/research-funding/human-subjects-research/policies-clinical-researchers</a>; and additionally will support oversight and management of current ongoing LCN Cohort and LCN RESCU Studies.   If new Steering Committee and NIDDK sanctioned protocol development is considered, the SDCC will provide sample size calculations, statistical advice, questionnaires, and data analysis; coordinate implementation, training, and logistical and management support for the conduct of the studies; support manuscript preparation; organize committee meetings; assist in the establishment, coordination, and management of a central or single Institutional Review Board for the Liver Cirrhosis Network; and provide overall study coordination and quality assurance, including coordination of the logistical activities of the Data and Safety Monitoring Board, the Steering Committee and other standing committees; coordination of the biospecimens, tracking, distribution, and eventual depositing of both data and biospecimens into the NIDDK Data and Biospecimen Repository as per NIDDK policy (<a href="https://repository.niddk.nih.gov/home">https://repository.niddk.nih.gov/home</a>).</p><p>The NIDDK/NIH will be responsible for organizing and providing support for the Liver Cirrhosis Network and will be involved substantially with the awardees as a "partner," consistent with the Cooperative Agreement mechanism.  A designated NIDDK Project Scientist, who will provide scientific oversight, will monitor subject recruitment and study progress, ensure disclosure of conflicts of interest and Network adherence to NIDDK policies. The NIDDK will appoint all members of the DSMB. An additional NIDDK Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.</p><p>This is a Notice of Funding Opportunity (NOFO) for a Single Source that will invite application(s) from eligible organization(s) to apply. Please see Section III. Eligibility for additional information. In accordance with NIH standard peer-review processes, the application(s) will be peer-reviewed, and only meritorious application(s) will be considered for funding.<br> </p>
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<div data-element-id="261409" data-element-has-label="false" data-element-required="false" data-element-has-value="true" data-section-code="FOD" data-element-type="TEXT">
<a id='_bookmark261409' tabindex='-1' aria-hidden='true'></a><p>Investigators proposing NIH-defined clinical trials may refer to the <a href="https://researchmethodsresources.nih.gov/">Research Methods Resources</a> website for information about developing statistical methods and study designs.</p>
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<div data-element-id="261410" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="FOD" data-element-type="TEXT">
<a id='_bookmark261410' tabindex='-1' aria-hidden='true'></a><p>See <a href="#_Section_VIII._Other">Section VIII. Other Information</a> for award authorities and regulations.</p>
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<a id='_bookmark261411' tabindex='-1' aria-hidden='true'></a><a name="_Section II. Award Information"></a><h2>Section II. Award Information</h2>
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<div class="row" data-index="40">
<div class="col-md-4 datalabel" tabindex="0" data-element-id="261412" data-element-required="true" data-element-has-value="true" data-section-code="AI" data-element-type="TEXT">
<a id='_bookmark261412' tabindex='-1' aria-hidden='true'></a>Funding Instrument
</div>
<div class=" col-md-8 datacolumn">
<p>Cooperative Agreement: A financial assistance mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this NOFO.</p>
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<div class="row" data-index="41">
<div class="col-md-4 datalabel" tabindex="0" data-element-id="261413" data-element-required="true" data-element-has-value="true" data-section-code="AI" data-element-type="LINKED_ELEMENT">
<a id='_bookmark261413' tabindex='-1' aria-hidden='true'></a> Application Types Allowed
</div>
<div class=" col-md-8 datacolumn">
Renewal
<br>
Revision
<br>
</div>
</div>

<div class="row" data-index="43">
<div class="col-md-push-4 col-md-8 datacolumn">
<a id='_bookmark261415' tabindex='-1' aria-hidden='true'></a><p>The <a href="http://grants.nih.gov/grants/guide/url_redirect.htm?id=11116">OER Glossary</a> and the <a href="https://grants.nih.gov/grants/guide/url_redirect.htm?id=82400">How to Apply - Application Guide</a> provide details on these application types. Only those application types listed here are allowed for this NOFO.</p>
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<div class="row" data-index="44">
<div class="col-md-4 datalabel" tabindex="0" data-element-id="261416" data-element-required="false" data-element-has-value="true" data-section-code="AI" data-element-type="TEXT">
<a id='_bookmark261416' tabindex='-1' aria-hidden='true'></a>Clinical Trial?
</div>
<div class=" col-md-8 datacolumn">
<p>Optional: Accepting applications that either propose or do not propose clinical trial(s).</p>
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</div>

<div class="row" data-index="45">
<div class="col-md-push-4 col-md-8 datacolumn">
<a id='_bookmark261417' tabindex='-1' aria-hidden='true'></a><p><a href="https://grants.nih.gov/grants/guide/url_redirect.htm?id=82370">Need help determining whether you are doing a clinical trial?</a></p>
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<div class="row" data-index="46">
<div class="col-md-4 datalabel" tabindex="0" data-element-id="261418" data-element-required="true" data-element-has-value="true" data-section-code="AI" data-element-type="TEXT">
<a id='_bookmark261418' tabindex='-1' aria-hidden='true'></a>Funds Available and Anticipated Number of Awards
</div>
<div class=" col-md-8 datacolumn">
<p>The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) intends to commit $1,850,000 in FY 2026 to fund one award.</p>
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<div class="row" data-index="47">
<div class="col-md-4 datalabel" tabindex="0" data-element-id="261419" data-element-required="true" data-element-has-value="true" data-section-code="AI" data-element-type="TEXT">
<a id='_bookmark261419' tabindex='-1' aria-hidden='true'></a>Award Budget
</div>
<div class=" col-md-8 datacolumn">
<p>Application budgets are not limited but need to reflect the actual needs of the proposed project.</p>
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</div>

<div class="row" data-index="48">
<div class="col-md-4 datalabel" tabindex="0" data-element-id="261420" data-element-required="true" data-element-has-value="true" data-section-code="AI" data-element-type="TEXT">
<a id='_bookmark261420' tabindex='-1' aria-hidden='true'></a>Award Project Period
</div>
<div class=" col-md-8 datacolumn">
<p>The scope of the proposed project should determine the project period. The maximum project period is 5 years.</p>
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<div data-element-id="261421" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="AI" data-element-type="TEXT">
<a id='_bookmark261421' tabindex='-1' aria-hidden='true'></a><p>NIH grants policies as described in the <a href="http://grants.nih.gov/grants/guide/url_redirect.htm?id=11120">NIH Grants Policy Statement</a> will apply to the applications submitted and awards made from this NOFO.</p>
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<a id='_bookmark261422' tabindex='-1' aria-hidden='true'></a><a name="_Section III. Eligibility Information"></a><h2>Section III. Eligibility Information</h2>
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<a id='_bookmark261423' tabindex='-1' aria-hidden='true'></a><h4>1. Eligible Applicants</p>
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<div class="heading4" tabindex="0" data-element-id="261424" data-element-required="true" data-element-has-value="true" data-section-code="EI" data-element-type="TEXT">
<a id='_bookmark261424' tabindex='-1' aria-hidden='true'></a>Eligible Organizations
</div>

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<p>Only the following applicant is eligible to apply for this single source funding: Northwestern University. Please refer to Section I. Notice of Funding Opportunity Information for more details.</p>
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<div data-element-id="261428" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="EI" data-element-type="TEXT">
<a id='_bookmark261428' tabindex='-1' aria-hidden='true'></a><h4>Foreign Organizations/Foreign Collaborations</h4>
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<div data-element-id="261429" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="EI" data-element-type="RADIO_BUTTON">
<a id='_bookmark261429' tabindex='-1' aria-hidden='true'></a><p class="Normal">Non-domestic (non-U.S.) Entities (Foreign Organizations) <strong>are not</strong> eligible to apply.</p>
</div>

<div data-element-id="261430" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="EI" data-element-type="RADIO_BUTTON">
<a id='_bookmark261430' tabindex='-1' aria-hidden='true'></a><p>Non-domestic (non-U.S.) components of U.S. Organizations <strong>are not</strong> eligible to apply.</p>
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<div data-element-id="261431" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="EI" data-element-type="RADIO_BUTTON">
<a id='_bookmark261431' tabindex='-1' aria-hidden='true'></a><p>Foreign components, as <a href="http://grants.nih.gov/grants/guide/url_redirect.htm?id=11118">defined in the <em>NIH Grants Policy Statement</em></a>, <strong>are not</strong> allowed. </p>
</div>

<div class="heading4" tabindex="0" data-element-id="261432" data-element-required="true" data-element-has-value="true" data-section-code="EI" data-element-type="TEXT">
<a id='_bookmark261432' tabindex='-1' aria-hidden='true'></a>Required Registrations
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<p><strong>Applicant Organizations</strong></p>

<p>Applicant organizations must complete and maintain the following registrations as described in the <a href="https://grants.nih.gov/grants/guide/url_redirect.htm?id=82400">How to Apply - Application Guide</a> to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference <a href="http://grants.nih.gov/grants/guide/url_redirect.htm?id=82423">NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications</a> for additional information</p>

<ul>
<li><a href="https://grants.nih.gov/grants/guide/url_redirect.htm?id=82390">System for Award Management (SAM) –</a> Applicants must complete and maintain an active registration, <strong>which requires renewal at least annually</strong>. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.

<ul>
<li><a href="http://grants.nih.gov/grants/guide/url_redirect.htm?id=11176">NATO Commercial and Government Entity (NCAGE) Code</a> – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.</li>
<li>Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.</li>
</ul>
</li>
<li><a href="https://grants.nih.gov/grants/guide/url_redirect.htm?id=11123">eRA Commons</a> - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.</li>
<li><a href="http://grants.nih.gov/grants/guide/url_redirect.htm?id=82300">Grants.gov</a> – Applicants must have an active SAM registration in order to complete the Grants.gov registration.</li>
</ul>

<p><strong>Program Directors/Principal Investigators (PD(s)/PI(s))</strong></p>

<p>All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.</p>
</div>

<div class="heading4" tabindex="0" data-element-id="261433" data-element-required="true" data-element-has-value="true" data-section-code="EI" data-element-type="TEXT">
<a id='_bookmark261433' tabindex='-1' aria-hidden='true'></a>Eligible Individuals (Program Director/Principal Investigator)
</div>

<div data-element-id="261433" data-element-has-label="true" data-element-required="true" data-element-has-value="true" data-section-code="EI" data-element-type="TEXT">
<p>Only the PI/PDs associated with the award issued under RFA DK-20-004 to Northwestern University is eligible to apply for this single source funding. Please refer to Section I. Notice of Funding Opportunity Information for more details.</p><p>For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the <a href="https://grants.nih.gov/grants/guide/url_redirect.htm?id=82400">How to Apply - Application Guide</a>.</p>
</div>

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Focus Areas & Funding Uses

Fields of Work

$2,000,000 - $5,000,000

Deadline

April 13, 2026

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Single Source Renewal for the Continuation of the Liver Cirrhosis Network: Scientific and Data Coordination Center (U24 Clinical Trial Optional)

Overview

Single Source Renewal for the Continuation of the Liver Cirrhosis Network: Scientific and Data Coordination Center (U24 Clinical Trial Optional)

Details

Eligibility

Eligibility

Eligible Applicant Types

How to Apply

RFA-DK-26-309-Full-Announcement.html

Focus Areas & Funding Uses

Fields of Work

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Ready to apply for Single Source Renewal for the Continuation of the Liver Cirrhosis Network: Scientific and Data Coordination Center (U24 Clinical Trial Optional)?