Limited Competition Renewal for the Continuation of the Liver Cirrhosis Network: Clinical Research Centers (U01 Clinical Trial Required)
National Institutes of Health
Funding Amount
Up to $330,214
Deadline
March 8, 2027
333 days left
Grant Type
federal
Overview
Limited Competition Renewal for the Continuation of the Liver Cirrhosis Network: Clinical Research Centers (U01 Clinical Trial Required)
This is a Notice of Funding Opportunity (NOFO) for a Limited Competition that will invite applications from eligible organizations to apply. Please see Section III. Eligibility for additional information. In accordance with NIH standard peer-review processes, the applications will be peer-reviewed, and only meritorious applications will be considered.
Details
- Agency: National Institutes of Health
- Department: Department of Health and Human Services
- Opportunity #: RFA-DK-26-308
- Total Funding: $3,302,147
- Expected Awards: 10
- Instrument: cooperative_agreement
Eligibility
Refer to Section III. Eligibility Information in the NOFO for additional information on eligibility.This is a Limited Competition funding opportunity intended to fund organizations who are grant recipients of RFA-DK-20-003.Foreign Organizations/International 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
How to Apply
RFA-DK-26-308-Full-Announcement.html
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<title>RFA-DK-26-308: Limited Competition Renewal for the Continuation of the Liver Cirrhosis Network: Clinical Research Centers (U01 Clinical Trial Required)</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='_bookmark261213' 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='_bookmark261214' 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='_bookmark261216' 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='_bookmark261218' tabindex='-1' aria-hidden='true'></a>Funding Opportunity Title
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<span class="title">Limited Competition Renewal for the Continuation of the Liver Cirrhosis Network: Clinical Research Centers (U01 Clinical Trial Required)</span>
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<a id='_bookmark261219' tabindex='-1' aria-hidden='true'></a>Activity Code
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<p><a href="http://grants.nih.gov/grants/funding/ac_search_results.htm?text_curr=u01&Search.x=0&Search.y=0&Search_Type=Activity">U01</a> Research Project – Cooperative Agreements</p>
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<a id='_bookmark261220' tabindex='-1' aria-hidden='true'></a>Announcement Type
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Reissue of
<a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-DK-20-003.html" target="_blank" rel="noreferrer">RFA-DK-20-003</a>
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<a id='_bookmark261221' 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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<a id='_bookmark261222' tabindex='-1' aria-hidden='true'></a>Funding Opportunity Number (FON)
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<span class="noticenum">RFA-DK-26-308</span>
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<a id='_bookmark261223' tabindex='-1' aria-hidden='true'></a>Companion Funding Opportunity
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<div class=" col-md-8 datacolumn">
<a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-DK-26-309.html" target="_blank" rel="noreferrer">RFA-DK-26-309</a>
<span class="separator" style="position:relative;left:-3px">,</span> <a href="https://grants.nih.gov/grants/funding/ac_search_results.htm?text_curr=U24&&Search.x=0&&Search.y=0&&Search_Type=Activity" target="_blank" rel="noreferrer">U24</a>
Resource-Related Research Project (Cooperative Agreements)
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<a id='_bookmark261224' tabindex='-1' aria-hidden='true'></a>Number of Applications
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<p>Only one application per institution is allowed, as defined in Part 2, Section III. 3. Additional Information on Eligibility</p>
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<a id='_bookmark261225' tabindex='-1' aria-hidden='true'></a>Assistance Listing Number(s)
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93.847
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<a id='_bookmark261226' tabindex='-1' aria-hidden='true'></a>Funding Opportunity Purpose
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<p>This is a Notice of Funding Opportunity (NOFO) for a Limited Competition that will invite applications from eligible organizations to apply. Please see Section III. Eligibility for additional information. In accordance with NIH standard peer-review processes, the applications will be peer-reviewed, and only meritorious applications will be considered.</p>
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<a id='_bookmark261228' tabindex='-1' aria-hidden='true'></a>Funding Opportunity Goal(s)
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<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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February 06, 2026
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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>
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Not Applicable
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March 06, 2026
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<td> October 2026
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Not Applicable
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March 08, 2027
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Not Applicable
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<td> October 2027
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<td>December 2027</td>
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<a id='_bookmark261235' 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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<p>Not Applicable</p>
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March 09, 2027
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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 Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, 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='_bookmark262235' 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='_bookmark261245' tabindex='-1' aria-hidden='true'></a><a name="_Part 2. Full Text of Announcement"></a><h1>Part 2. Full Text of Announcement</h1>
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<a id='_bookmark261246' 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="261247" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="FOD" data-element-type="TEXT">
<a id='_bookmark261247' tabindex='-1' aria-hidden='true'></a><p>Purpose:</p><p>The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is proposing the continuation of the Liver Cirrhosis Network through this Limited Competition Notice of Funding Opportunity Announcement which is renewing the LCN Clinical Centers awarded under RFA-DK-20-003. Please see Section III. Eligibility for additional information.In conjunction with RFA-DK-26-309 NIDDK is renewing the LCN Scientific Data Coordination Center, to continue the long-term follow-up of patients enrolled in the LCN Cohort Study; and to complete enrollment and the two years of treatment and follow up of patients the LCN RESCU trials.In accordance with NIH standard peer-review processes, the applications will be peer-reviewed, and only meritorious applications will be considered.</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>Objectives:</p><p>Clinical Center applications in response to this Notice of Funding Opportunity are charged with the enhancing patient recruitment and retention to complete the research goals in the LCN Cohort Study and RESCU Trial. The central and critical objective of this NOFO is to promote clinical and translational research on cirrhosis that might lead to means of treatment, amelioration, and possible reversal. To this end, applications in response to the NOFO are required to describe approaches, strategies, and methodologies that will promote the completion of enrollment; the retention of enrolled patients; the collection of biospecimens; and analyses of data that would better define factors that might improve long-term outcomes of patients with cirrhosis. Description of improving enrollment should discuss how to capture patients with cirrhosis who are also living with human immunodeficiency virus infection that reflects representation of the local and regional population of the participating center.</p><p>The scientific potential of the LCN data and biospecimen collection is expected to strengthen as each LCN study nears and achieves enrollment completion. The completed enrollment of the LCN Cohort study and LCN RESCU trial will provide an extensive database of serial clinical, biochemical, and radiologic results that can be used to shed light on the causes of disease progression ore regression. As such, each applicant to this NOFO must propose a single, separate Scientific Exploratory Specific Aim that must utilize and leverage the LCN data and biospecimen collection. The scientific pursuits should be distinct and non-overlapping with the scientific objectives of the LCN Cohort and RESCU Studies. Examples of topics; discovering, evaluating or determining biomarker assays of alcohol exposure or for development of hepatocellular carcinoma, portal hypertension, frailty and sarcopenia; analyses of genomic, proteomic, and other omic platforms; integration of bioinformatics or imaging processing and reading centralization in service of LCN research activities; analysis of environmental, dietary, or nutritional factors that might worsen compensated cirrhosis. This list of topics serves only as examples and is not complete. The intent of the Scientific Exploratory Specific Aim is to assess each applicant’s understanding of the LCN data and biospecimen resources and of pressing scientific issues pertaining to cirrhosis. Please note that the Scientific Exploratory Specific Aim will not be initiated or operationalized within the LCN unless future funds beyond this NOFO become available to specifically support these Exploratory Aims. For that reason, a budget for the Scientific Exploratory Specific Aim must not be included in the application to this NOFO.</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 award recipients 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 in support of the Liver Cirrhosis Network research and data management activities will seek renewal through a separate NOFO, the details of which may be accessed at RFA-DK-26-309. In brief, the SDCC 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 grant recipients 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>
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<a id='_bookmark261249' 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="261250" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="FOD" data-element-type="TEXT">
<a id='_bookmark261250' 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='_bookmark261251' tabindex='-1' aria-hidden='true'></a><a name="_Section II. Award Information"></a><h2>Section II. Award Information</h2>
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<a id='_bookmark261252' tabindex='-1' aria-hidden='true'></a>Funding Instrument
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<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="col-md-4 datalabel" tabindex="0" data-element-id="261253" data-element-required="true" data-element-has-value="true" data-section-code="AI" data-element-type="LINKED_ELEMENT">
<a id='_bookmark261253' tabindex='-1' aria-hidden='true'></a> Application Types Allowed
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Renewal
<br>
Revision
<br>
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<a id='_bookmark261255' 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 How to Apply Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.</p>
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<a id='_bookmark261256' tabindex='-1' aria-hidden='true'></a>Clinical Trial?
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<p>Required: Only accepting applications that propose clinical trial(s).</p>
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<a id='_bookmark261257' 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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<a id='_bookmark261258' tabindex='-1' aria-hidden='true'></a>Funds Available and Anticipated Number of Awards
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<p>The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) intends to commit $3,300,000 in FY 2026 to fund up to ten awards.</p>
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<a id='_bookmark261259' tabindex='-1' aria-hidden='true'></a>Award Budget
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<p>Application budgets are not limited but need to reflect the actual needs of the proposed project.</p>
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<a id='_bookmark261260' tabindex='-1' aria-hidden='true'></a>Award Project Period
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<p>The scope of the proposed project should determine the project period. The maximum project period is 5 years.</p>
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<a id='_bookmark261261' 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='_bookmark261262' 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='_bookmark261263' tabindex='-1' aria-hidden='true'></a><h4>1. Eligible Applicants</p>
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<a id='_bookmark261264' tabindex='-1' aria-hidden='true'></a>Eligible Organizations
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<p>Higher Education Institutions - Includes all types</p><ul><li>Public/State Controlled Institutions of Higher Education</li><li>Private Institutions of Higher Education</li></ul><p>Nonprofits Other Than Institutions of Higher Education</p><ul><li>Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)</li><li>Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)</li></ul><p>For-Profit Organizations</p><ul><li>Small Businesses</li><li>For-Profit Organizations (Other than Small Businesses)</li></ul><p>Local Governments</p><ul><li>State Governments</li><li>County Governments</li><li>City or Township Governments</li><li>Special District Governments</li><li>Indian/Native American Tribal Governments (Federally Recognized)</li><li>Indian/Native American Tribal Governments (Other than Federally Recognized).</li></ul>
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<a id='_bookmark261265' tabindex='-1' aria-hidden='true'></a><p>Federal Governments</p>
<ul>
<li>Eligible Agencies of the Federal Government</li>
<li>U.S. Territory or Possession</li>
</ul>
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<a id='_bookmark261266' tabindex='-1' aria-hidden='true'></a><p>Other</p>
<ul>
<li>Independent School Districts</li>
<li>Public Housing Authorities/Indian Housing Authorities</li>
<li>Native American Tribal Organizations (other than Federally recognized tribal governments)</li>
<li>Faith-based or Community-based Organizations</li>
<li>Regional Organizations</li>
</ul>
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<a id='_bookmark261267' tabindex='-1' aria-hidden='true'></a><p>This is a Limited Competition funding opportunity intended to fund organizations who are grant recipients of <a href="https://grants.nih.gov/grants/guide/rfa-files/rfa-dk-20-003.html">RFA-DK-20-003</a>.</p>
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<a id='_bookmark261268' tabindex='-1' aria-hidden='true'></a><h4>Foreign Organizations/International Collaborations</h4>
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<a id='_bookmark261269' 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>
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<div data-element-id="261270" 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='_bookmark261270' 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="261271" 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='_bookmark261271' tabindex='-1' aria-hidden='true'></a><p class="Normal">Foreign components, as <a href="http://grants.nih.gov/grants/guide/url_redirect.htm?id=11118">defined in the NIH Grants Policy Statement</a>, <b>are not </b>allowed.</p>
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<a id='_bookmark261272' 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 How to Apply- Application Guide 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 the <a href="http://grants.nih.gov/grants/guide/url_redirec
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