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2510 lines
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<HTML lang="en-US">
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<TITLE>Expired RFA-DK-20-021: Mechanistic Studies of the Interaction between SARS-CoV-2/COVID-19 and Diseases and Organ Systems of Interest to NIDDK (R01 Clinical Trial Optional)</TITLE>
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<META NAME="description" CONTENT="NIH Funding Opportunities and Notices in the NIH Guide for Grants and Contracts: Mechanistic Studies of the Interaction between SARS-CoV-2/COVID-19 and Diseases and Organ Systems of Interest to NIDDK (R01 Clinical Trial Optional) RFA-DK-20-021. NIDDK">
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<META NAME="Keywords" CONTENT="RFA-DK-20-021: Mechanistic Studies of the Interaction between SARS-CoV-2/COVID-19 and Diseases and Organ Systems of Interest to NIDDK (R01 Clinical Trial Optional)">
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<meta name="viewport" content="width=device-width, initial-scale=1.0">
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<link href="../guide_styles/css/bootstrap.min.css" rel="stylesheet">
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<link href="../guide_styles/css/style.css" rel="stylesheet">
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<link href="../guide_styles/css/FOAM_Style.css" rel="stylesheet">
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</HEAD>
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<BODY>
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<link type="text/css" href="../guide_styles/css/expired.css" rel="stylesheet" media="all">
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<div class="noticeBar">This notice has expired. Check the <a href="https://grants.nih.gov/funding/searchguide/">NIH Guide</a> for active opportunities and notices.</div>
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<div id="watermark_background">
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<p id="watermark_text">EXPIRED</p>
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<div id="page-title" class="heading1" tabindex="0">Department of Health and Human Services</div></br>
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<div>
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<a name="_Part_1._Overview"></a><h1 class="heading1">Part 1. Overview Information</h1>
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</div>
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<div class="row" data-index="2">
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<div class="col-md-4 datalabel" tabindex="0">
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Participating Organization(s)
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<div class="col-md-8 datacolumn">
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<p>National Institutes of Health (<a href="http://www.nih.gov">NIH</a>)</p>
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<p></p>
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<div class="col-md-4 datalabel" tabindex="0">
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Components of Participating Organizations
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</div>
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<div class="col-md-8 datacolumn">
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<p>National Institute of Diabetes and Digestive and Kidney Diseases (<a href="https://www.niddk.nih.gov/" target="_blank">NIDDK</a>)
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<p></p>
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<div class="row" data-index="6">
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<div class="col-md-4 datalabel" tabindex="0">
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Funding Opportunity Title
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<div class="col-md-8 datacolumn">
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<span class="title">Mechanistic Studies of the Interaction between SARS-CoV-2/COVID-19 and Diseases and Organ Systems of Interest to NIDDK (R01 Clinical Trial Optional)</span>
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<div class="row" data-index="7">
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Activity Code
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</div>
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<div class="col-md-8 datacolumn">
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<p><a href="//grants.nih.gov/grants/funding/ac_search_results.htm?text_curr=r01&Search.x=0&Search.y=0&Search_Type=Activity">R01</a> Research Project Grant</p>
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Announcement Type
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<div class="col-md-8 datacolumn">
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<p class="Normal">New</p>
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<div class="row" data-index="9">
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<div class="col-md-4 datalabel" tabindex="0">
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Related Notices
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<ul><li><b>October 23, 2020 </b> - Notice of Pre-Application Webinar for RFA-DK-20-021. See Notice <a href="/grants/guide/notice-files/NOT-DK-21-001.html">NOT-DK-21-001</a>.</li> </ul>
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<div class="row" data-index="10">
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<div class="col-md-4 datalabel" tabindex="0">
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Funding Opportunity Announcement (FOA) Number
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</div>
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<div class="col-md-8 datacolumn">
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<span class="noticenum">RFA-DK-20-021</span>
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Companion Funding Opportunity
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<div class="col-md-8 datacolumn">
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<p class="Normal">None</p>
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Number of Applications
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<div class="col-md-8 datacolumn">
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<p>See <a href="#_3._Additional_Information">Section III. 3. Additional Information on Eligibility</a>.</p>
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<div class="row" data-index="13">
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<div class="col-md-4 datalabel" tabindex="0">
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Catalog of Federal Domestic Assistance (CFDA) Number(s)
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</div>
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<div class="col-md-8 datacolumn">
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<p class="Normal">93.847</p>
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<div class="col-md-4 datalabel" tabindex="0">
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Funding Opportunity Purpose
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<div class="col-md-8 datacolumn">
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<p class="Normal">The purpose of this Funding Opportunity Announcement (FOA) is to support basic and clinical mechanistic research on Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and Coronavirus Disease 2019 (COVID-19) susceptibility, routes of infection, course of disease, morbidity and mortality in people with pre-existing diseases, or adverse acute or chronic outcomes in organs, tissues, and biological systems of specific interest to NIDDK. These include diabetes and other metabolic diseases, obesity, and endocrine, digestive, liver, pancreas, kidney, urological, and hematologic tissues and diseases.</p>
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<a name="_Key_Dates"></a><h2 class="heading2">Key Dates</h2>
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</div>
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<div class="row" data-index="16">
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<div class="col-md-4 datalabel" tabindex="0">
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Posted Date
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July 10, 2020
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<div class="row" data-index="17">
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<div class="col-md-4 datalabel" tabindex="0">
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Open Date (Earliest Submission Date)
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</div>
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<div class="col-md-8 datacolumn">
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November 16, 2020
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<div class="row" data-index="18">
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<div class="col-md-4 datalabel" tabindex="0">
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Letter of Intent Due Date(s)
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</div>
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<div class="col-md-8 datacolumn">
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<p class="Normal">November 16, 2020</p>
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<div class="row" data-index="19">
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Application Due Date(s)
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</div>
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<div class="col-md-8 datacolumn">
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<p class="Normal" style="margin:0in 0in 0.0001pt">December 16, 2020</p>
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<p><p style="margin:0in 0in 0.0001pt">All applications are due by 5:00 PM local time of applicant organization. All <a href="#Application Types Allowed">types of non-AIDS applications</a> allowed for this funding opportunity announcement are due on the listed date(s).</p>
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<p style="margin:0in 0in 0.0001pt">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></p>
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<div class="row" data-index="21">
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<div class="col-md-4 datalabel" tabindex="0">
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AIDS Application Due Date(s)
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</div>
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<div class="col-md-8 datacolumn">
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<p class="Normal" style="margin:0in 0in 0.0001pt">December 16, 2020</p>
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<p class="Normal" style="margin:0in 0in 0.0001pt">All applications are due by 5:00 PM local time of applicant organization. All <a href="#Application Types Allowed">types of AIDS and AIDS-related applications</a> allowed for this funding opportunity announcement are due on the listed date(s).</p>
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<p class="Normal" style="margin:0in 0in 0.0001pt">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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<div class="row" data-index="22">
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Scientific Merit Review
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<div class="col-md-8 datacolumn">
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<p class="Normal">February/March<font color="#001000" face="Helvetica" style="background-color: transparent;"> 2021</font></p>
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Advisory Council Review
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<div class="col-md-8 datacolumn">
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<p class="Normal">May 2021</p>
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<div class="col-md-4 datalabel" tabindex="0">
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Earliest Start Date
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</div>
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<div class="col-md-8 datacolumn">
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<p class="Normal">July 2021</p>
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Expiration Date
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December 17, 2020
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<div class="col-md-4 datalabel" tabindex="0">
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Due Dates for E.O. 12372
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<p>Not Applicable</p>
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<div class="heading4" tabindex="0" >
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Required Application Instructions
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</div>
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<div>
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<p>It is critical that applicants follow the instructions in the Research (R) Instructions in the <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=12000">SF424 (R&R) Application Guide</a>,except where instructed to do otherwise (in this FOA or in a Notice from <a href="//grants.nih.gov/grants/guide/">NIH Guide for Grants and Contracts </a>).</p>
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<p>Conformance to all requirements (both in the Application Guide and the FOA) 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 <a href="#_Section_IV._Application_1">Section IV</a>. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.</p>
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<p><strong>Applications that do not comply with these instructions may be delayed or not accepted for review.</strong></p>
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<div>
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<style>
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.assist_button {
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background-color: #4CAF50; /* Green */
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border: none;
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color: white;
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padding: 8px 16px;
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text-align: center;
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text-decoration: none;
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display: inline-block;
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font-size: 14px;
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}
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.important {
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color: #F00;
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font-weight: bold;
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font-size 14px;
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}
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</style>
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<div class="heading1" tabindex="0">Table of Contents</div>
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<div class="toc-link"><a href="#_Part_1._Overview">Part 1. Overview Information
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</a></div><div class="toc-link P_SingleIndent"><a href="#_Key_Dates">Key Dates
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</a></div><div class="toc-link"><a href="#_Part_2._Full">Part 2. Full Text of Announcement
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</a></div><div class="toc-link P_SingleIndent"><a href="#_Section_I._Funding">Section I. Funding Opportunity Description
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</a></div><div class="toc-link P_SingleIndent"><a href="#_Section_II._Award_1">Section II. Award Information
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</a></div><div class="toc-link P_SingleIndent"><a href="#_Section_III._Eligibility">Section III. Eligibility Information
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</a></div><div class="toc-link P_SingleIndent"><a href="#_Section_IV._Application_1">Section IV. Application and Submission Information
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</a></div><div class="toc-link P_SingleIndent"><a href="#_Section_V._Application">Section V. Application Review Information
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</a></div><div class="toc-link P_SingleIndent"><a href="#_Section_VI._Award">Section VI. Award Administration Information
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</a></div><div class="toc-link P_SingleIndent"><a href="#_Section_VII._Agency">Section VII. Agency Contacts
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</a></div><div class="toc-link P_SingleIndent"><a href="#_Section_VIII._Other">Section VIII. Other Information
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</a></div>
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</div><br/>
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<div>
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<a name="_Part_2._Full"></a><h1 class="heading1">Part 2. Full Text of Announcement</h1>
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</div>
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<div>
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<a name="_Section_I._Funding"></a><h2 class="heading2">Section I. Funding Opportunity Description</h2>
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</div>
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<div>
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<p class="Normal"><strong>Background</strong></p>
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<p class="Normal">Patients with many underlying diseases and conditions are at increased risk of acquiring and having adverse outcomes from SARS-CoV-2 infection. In addition, emerging evidence suggests that many organs are targeted by this virus, which contributes significantly to COVID-19 morbidity and leads to organ-specific complications after recovery from infection. NIDDK is interested in diabetes and other metabolic diseases, obesity, and endocrine, digestive, hepatobiliary, pancreas, kidney, urological and hematologic tissues and diseases. Mechanistic understanding of the ways that SARS-CoV-2 infects and affects these organs and systems, including individual susceptibility to infection and acute and long-term sequalae of COVID-19, are largely unknown. Investigations of those mechanisms are expected to contribute to additional strategies for management of SARS-CoV-2 infected individuals with concurrent diseases and conditions or new organ- or system-specific sequalae of infection.</p>
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<p class="Normal"><strong>Research Objectives and Scope</strong></p>
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<p class="Normal">NIDDK solicits new research in human subjects or model organisms, using isolated tissues, cells, or in vivo approaches to delineate and address mechanisms by which people with diseases in the mission of NIDDK have poor outcomes from SARS-CoV-2 infection, including variable susceptibility, altered course of disease, morbidity and mortality. Research focused on how SARS-CoV-2 and COVID-19 lead to acute or chronic damage to organs, contributing to development of the diseases of interest to NIDDK, is also responsive. The knowledge gained will contribute a new evidence base to accelerate advances in diagnostics, therapeutics, clinical management, and public health innovation, as related to diseases and outcomes of interest to NIDDK.</p>
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<p class="Normal">Our communities already affected by health disparities are also suffering disproportionally due to the COVID-19 pandemic. Much of this is likely due to elevated exposure to the disease because of social issues, family, employment, and other economic circumstances, issues that are not easily addressed by basic biomedical research. However, NIDDK urges researchers to work to provide a biological knowledge basis for improving prevention and care for everyone, particularly our most vulnerable and affected neighbors.</p>
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<p class="Normal">Most of what is known about SARS-CoV-2 and COVID-19 comes from anecdote, observational clinical studies, epidemiological studies, or from studies focused on other related infectious agents. While it is clear that there is an interaction between COVID-19 and diseases of interest to NIDDK and that organs of interest to NIDDK can be adversely impacted by infection, the nature of this disease is still largely unknown. While there are numerous intriguing hypotheses regarding the pathways involved, it is likely too soon to expect a great deal of compelling preliminary data to support those hypotheses. Therefore, applicants to this FOA are not expected to have substantial preliminary data from COVID-19 patients or animal or cell models of COVID-19. However, applicants are encouraged to provide compelling justification for the significance, relevance, and feasibility of their proposed research.</p>
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<p class="Normal"><strong>This FOA is not intended to test novel drug therapies, such as Phase 1-3 interventional clinical trials. Projects primarily focused on pathways of viral infection, invasion, and shedding, without consideration of pathogenic consequences to NIDDK-relevant host organs/tissues/cells will be considered nonresponsive to this FOA. </strong></p>
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<p class="Normal"><strong>Specific Areas of Research Interest</strong></p>
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<p class="Normal">The intent of this FOA is to support mechanistic oriented work on the pathways responsible for increased adverse outcomes, either due to diseases of interest to NIDDK or that result in damage to organs of interest to NIDDK, in cells, tissues, animal models and human subjects, including but not limited to:</p>
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<ul>
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<li class="Normal">Identifying the pathways involved in altered susceptibility, routes of infection, course of disease, and adverse outcomes including death due to COVID-19 in people with diseases of interest to NIDDK;</li>
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<li class="Normal">Identifying mechanisms responsible for acute and chronic organ and system dysfunction and sequalae due to infection, in the presence or absence of diseases of interest to NIDDK;</li>
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<li class="Normal">Contributing to an understanding of the many roles of health disparities in risk of infection, organ injury and adverse outcomes. The goal is to prevent and better treat COVID-19 and its sequelae, and to prevent death and long-term disability from COVID-19 infection in people from communities that suffer from health disparities;</li>
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<li class="Normal">In patients that are co-infected with SARS-CoV-2 and HIV/AIDS, it is a priority to understand the mechanisms by which organs and tissues that manifest diseases relevant to the NIDDK mission are negatively impacted by SARS-CoV-2/COVID-19;</li>
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<li class="Normal">Understanding how mechanisms and routes of viral infection contribute to pathogenic processes in tissues and diseases of interest to NIDDK;</li>
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<li class="Normal">Providing mechanistic information that would inform on risk factors and biomarkers related to variable clinical presentation, organ and system injury and outcomes;</li>
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<li class="Normal">Probing interactions between COVID-19 susceptibility and severity, and drugs or other therapies used to treat diseases of interest to NIDDK;</li>
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<li class="Normal">Conducting small pilot studies to obtain mechanistic information from clinical trials, observational studies, and sample collections.</li>
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</ul>
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<p class="Normal">For diabetes, metabolic and endocrine diseases, study questions could include, but are not limited to:</p>
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<ul>
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<li class="Normal">Exploring the mechanisms for any increased susceptibility or altered course of COVID-19 due to type 1 or type 2 diabetes or diabetic complications;</li>
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<li class="Normal">Identifying the roles of dysregulated glycemia, insulin resistance, insulin secretion, etc. in severity of response to COVID-19 infection;</li>
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<li class="Normal">Exploring mechanisms whereby COVID-19 infection results in acute or chronic metabolic dysfunction, or the onset of diabetes or other endocrine diseases;</li>
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<li class="Normal">Identifying mechanisms involved in alterations in the course of existing type 1 or type 2 diabetes or the complications of diabetes following COVID-19 infection.</li>
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</ul>
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<p class="Normal">For obesity and nutrition, study questions could include, but are not limited to:</p>
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<ul>
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<li class="Normal">Identifying the specific tissues, biological systems and pathways that explain the increased susceptibility, greater severity, or diminished response to treatment for COVID-19 in patients with obesity;</li>
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<li class="Normal">Elucidating the aspects of adipose tissue biology that could play a key role in regulating or modulating the severity of COVID-19 infection, disease course, response to treatment, and outcomes in the obese state;</li>
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<li class="Normal">Determining the mechanisms by which differences in nutritional status, including micronutrient status and metabolism, impact observed variability and disparities in COVID-19 susceptibility, course, and response to treatment;</li>
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<li class="Normal">Determining the mechanisms by which diet-host-microbiome interactions impact the course of COVID-19 infection and/or are impacted by COVID-19 infection.</li>
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</ul>
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<p class="Normal">For digestive diseases and liver diseases, study questions could include, but are not limited to:</p>
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<ul>
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<li class="Normal">Understanding the mechanisms by which SARS-CoV-2/COVID-19 induces disease flares, exacerbates disease activity, or otherwise contributes to adverse disease outcomes in patients with underlying digestive diseases including inflammatory bowel disease, functional bowel syndromes, gastroparesis, pancreatitis, chronic hepatitis and cirrhosis, cholestatic liver diseases, autoimmune liver diseases and nonalcoholic fatty liver disease;</li>
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<li class="Normal">Determining if SARS-CoV-2 induces pathology in GI and liver cell types/organs that express SARS-CoV-2 viral receptors, such as ileal enterocytes, endothelium and fibroblasts, pancreatic ductal cells, and all cells of the liver;</li>
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<li class="Normal">Determining how SARS-CoV-2 interacts with the enteric nervous system to either worsen GI diseases within the mission of the Division of Digestive Diseases and Nutrition or to spread to other organs or the central nervous system;</li>
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<li class="Normal">Determining how SARS-CoV-2 may induce diarrhea, nausea, and vomiting, symptoms that are well-known to present with COVID-19 disease.</li>
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</ul>
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<p class="Normal">For kidney, urologic, and hematologic diseases<strong>, </strong>study questions could include, but are not limited to:</p>
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<ul>
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<li class="Normal">Identifying factors and mechanisms by which renal disease portends worse COVID-19 related morbidity and mortality;</li>
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<li class="Normal">Exploring factors and mechanisms by which COVID-19 might uniquely increase the incidence or severity of acute kidney injury (AKI);</li>
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<li class="Normal">Determining if SARS-CoV2 causes direct kidney injury and if so, to which cells and by which mechanisms;</li>
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<li class="Normal">Exploring mechanisms by which COVID-19 may negatively impact renal function and related outcomes in individuals with renal transplants or glomerulonephritis (GN);</li>
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<li class="Normal">Exploring effects of COVID-19 on the structure and function of urologic organs;</li>
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<li class="Normal">Identifying mechanisms by which COVID-19 and cytokine dysregulation alter hematopoietic stem and progenitor cell proliferation or function (e.g. myeloid blood cell production or tissue macrophage function);</li>
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<li class="Normal">Identifying biologic pathways and mechanisms that contribute to a significantly altered course of COVID-19 sequelae in cohorts of inherited cytopenias.</li>
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</ul>
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<p class="Normal">Due to the novelty and severity of the COVID-19 pandemic and lack of relevant published mechanistic data, it is likely that awardees from this FOA would benefit from interaction during the course of their research. We therefore expect to organize activities that would allow investigators to share their ideas and data, such as annual or more frequent virtual meetings.</p>
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<p class="Normal">NIDDK plans to host a pre-receipt informational webinar for researchers interested in applying for RFA DK-20-021. It will take place on Monday, November 9, 2020 at 3:00pm ET. Please register by writing to <a href="/cdn-cgi/l/email-protection#513c38323930343d7f3c343f223039113f38397f363e27"><span class="__cf_email__" data-cfemail="dcb1b5bfb4bdb9b0f2b1b9b2afbdb49cb2b5b4f2bbb3aa">[email protected]</span></a> with your name, affiliation and email address.</p>
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</div>
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<div>
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<p>See <a href="#_Section_VIII._Other">Section VIII. Other Information</a> for award authorities and regulations.</p>
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</div>
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<div>
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<a name="_Section_II._Award_1"></a><h2 class="heading2">Section II. Award Information</h2>
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</div>
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<div class="row" data-index="34">
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<div class="col-md-4 datalabel" tabindex="0">
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Funding Instrument
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</div>
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<div class="col-md-8 datacolumn">
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<p class="Normal">Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.</p>
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<div class="row" data-index="35">
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<div class="col-md-4 datalabel" tabindex="0">
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Application Types Allowed
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</div>
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<div class="col-md-8 datacolumn">
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New
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<!-- If there are no labels defined for table element, we treat that as 1 row and append the text. -->
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<p>The <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11116"><font color="#0000ff">OER Glossary</font></a> and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.</p>
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<div class="row" data-index="38">
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<div class="col-md-4 datalabel" tabindex="0">
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Clinical Trial?
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</div>
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<div class="col-md-8 datacolumn">
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Optional: Accepting applications that either propose or do not propose clinical trial(s)
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<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="40">
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<div class="col-md-4 datalabel" tabindex="0">
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Funds Available and Anticipated Number of Awards
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</div>
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<div class="col-md-8 datacolumn">
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<p class="Normal">NIDDK intends to commit $5,000,000 in FY 2021 to fund 11-13 awards.</p>
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<div class="row" data-index="41">
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<div class="col-md-4 datalabel" tabindex="0">
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Award Budget
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</div>
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<div class="col-md-8 datacolumn">
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<p class="Normal">Application budgets are limited to $250,000 in direct costs per year [exclusive of third-party facilities and administration (F&A) costs].</p>
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<div class="row" data-index="42">
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<div class="col-md-4 datalabel" tabindex="0">
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Award Project Period
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</div>
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<div class="col-md-8 datacolumn">
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<p class="Normal">The maximum project period is 3 years.</p>
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<p>NIH grants policies as described in the <a href="//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 FOA.</p>
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</div>
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<a name="_Section_III._Eligibility"></a><h2 class="heading2">Section III. Eligibility Information</h2>
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<h4 class="heading4">1. Eligible Applicants</h4>
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<div class="heading4" tabindex="0" >
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Eligible Organizations
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<div>
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<p class="Normal">Higher Education Institutions</p>
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<ul>
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<li class="Normal">Public/State Controlled Institutions of Higher Education</li>
|
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<li class="Normal">Private Institutions of Higher Education</li>
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</ul>
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<p class="Normal" style="margin-left: 25px;">The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:</p>
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<ul style="margin-left:25px;">
|
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<li class="Normal">Hispanic-serving Institutions</li>
|
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<li class="Normal">Historically Black Colleges and Universities (HBCUs)</li>
|
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<li class="Normal">Tribally Controlled Colleges and Universities (TCCUs)</li>
|
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<li class="Normal">Alaska Native and Native Hawaiian Serving Institutions</li>
|
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<li class="Normal">Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)</li>
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</ul>
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<p class="Normal">Nonprofits Other Than Institutions of Higher Education</p>
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<ul>
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<li class="Normal">Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)</li>
|
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<li class="Normal">Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)</li>
|
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</ul>
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<p class="Normal">For-Profit Organizations</p>
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<ul>
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<li class="Normal">Small Businesses</li>
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<li class="Normal">For-Profit Organizations (Other than Small Businesses)</li>
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</ul>
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<p class="Normal">Local Governments</p>
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<ul>
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<li class="Normal">State Governments</li>
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<li class="Normal">County Governments</li>
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<li class="Normal">City or Township Governments</li>
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<li class="Normal">Special District Governments</li>
|
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<li class="Normal">Indian/Native American Tribal Governments (Federally Recognized)</li>
|
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<li class="Normal">Indian/Native American Tribal Governments (Other than Federally Recognized)</li>
|
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</ul>
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</div>
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<div>
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<p class="Normal">Federal Governments</p><ul> <li class="Normal">Eligible Agencies of the Federal Government</li> <li class="Normal">U.S. Territory or Possession</li></ul>
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</div>
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<div>
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<p class="Normal">Other</p>
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<ul>
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<li class="Normal">Independent School Districts</li>
|
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<li class="Normal">Public Housing Authorities/Indian Housing Authorities</li>
|
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<li class="Normal">Native American Tribal Organizations (other than Federally recognized tribal governments)</li>
|
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<li class="Normal">Faith-based or Community-based Organizations</li>
|
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<li class="Normal">Regional Organizations</li>
|
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</ul>
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</div>
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<div>
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</div>
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<div class="heading4" tabindex="0" >
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Foreign Institutions
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</div>
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<div>
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</div>
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<div>
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<p>Non-domestic (non-U.S.) Entities (Foreign Institutions) <strong>are not</strong> eligible to apply.</p>
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</div>
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<div>
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<p>Non-domestic (non-U.S.) components of U.S. Organizations <strong>are not</strong> eligible to apply.</p>
|
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</div>
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<div>
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<p>Foreign components, as <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11118">defined in the <em>NIH Grants Policy Statement</em></a>, <strong>are </strong>allowed. </p>
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</div>
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<div class="heading4" tabindex="0" >
|
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Required Registrations
|
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</div>
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<div>
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<p class="Normal"><strong>Applicant organizations</strong></p>
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<p class="Normal">Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) 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. The <a href="//grants.nih.gov/grants/guide/notice-files/NOT-OD-15-039.html">NIH Policy on Late Submission of Grant Applications</a> states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.</p>
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<ul>
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<li><a href="http://fedgov.dnb.com/webform" Title="Link to Non-U.S. Government Site">Dun and Bradstreet Universal Numbering System (DUNS)</a> - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.</li>
|
|
<li><a href="https://www.sam.gov/portal/public/SAM/">System for Award Management (SAM)</a> Applicants must complete and maintain an active registration, which requires renewal at least annually. 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="//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>
|
|
</ul>
|
|
</li>
|
|
<li><a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11123">eRA Commons</a> - Applicants must have an active DUNS number to register in eRA Commons. </span></span></span>Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. </span></span></span>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>Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.</li>
|
|
</ul>
|
|
|
|
<p class="Normal"><strong>Program Directors/Principal Investigators (PD(s)/PI(s))</strong></p>
|
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|
|
<p class="Normal">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>
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</div>
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Eligible Individuals (Program Director/Principal Investigator)
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<p>Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.</p>
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<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 SF424 (R&R) Application Guide.</p>
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<h4 class="heading4">2. Cost Sharing</h4>
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<p>This FOA does not require cost sharing as defined in the <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11126">NIH Grants Policy Statement.</a></p>
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<h4 class="heading4"><a name="_3._Additional_Information"></a>3. Additional Information on Eligibility</h4>
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<label class="heading4">Number of Applications</label>
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<p class="Normal">Applicant organizations may submit more than one application, provided that each application is scientifically distinct.</p>
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<p class="Normal">The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:</p>
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<ul>
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<li class="Normal">A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.</li>
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<li class="Normal">A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.</li>
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<li class="Normal">An application that has substantial overlap with another application pending appeal of initial peer review (see <a href="//grants.nih.gov/grants/guide/notice-files/NOT-OD-11-101.html">NOT-OD-11-101</a>)</li>
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</ul>
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<a name="_Section_IV._Application_1"></a><h2 class="heading2">Section IV. Application and Submission Information</h2>
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<h4 class="heading4">1. Requesting an Application Package</h4>
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<p>The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace </span></span></span>are available in <a href="#_Required_Application_Instructions">Part 1</a> of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.</p>
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<h4 class="heading4">2. Content and Form of Application Submission</h4>
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It is critical that applicants follow the instructions in the Research (R) Instructions in the <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=12000">SF424 (R&R) Application Guide</a> except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
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<p class="Normal"><normal class="Normal"><label class="heading4">Letter of Intent</label> </normal></p>
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<p class="Normal">Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.</p>
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<p class="Normal">By the date listed in <a href="#_Part_1._Overview">Part 1. Overview Information</a>, prospective applicants are asked to submit a letter of intent that includes the following information:</p>
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<li class="Normal">Descriptive title of proposed activity</li>
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<li class="Normal">Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)</li>
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<li class="Normal">Names of other key personnel</li>
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<li class="Normal">Participating institution(s)</li>
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<li class="Normal">Number and title of this funding opportunity</li>
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</ul>
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<p class="Normal">The letter of intent should be sent to:</p>
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<p class="Normal">John F. Connaughton, Ph.D.<br />
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Chief, Scientific Review Branch<br />
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)<br />
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Telephone: 301-594-7797<br />
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Email: <a href="/cdn-cgi/l/email-protection#b1fff8f5f5fafdd4c5c5d4c3ded7d8dfc5d4dfc5f1dcd0d8dd9fdfd8d99fd6dec7"><span class="__cf_email__" data-cfemail="b4fafdf0f0fff8d1c0c0d1c6dbd2dddac0d1dac0f4d9d5ddd89adadddc9ad3dbc2">[email protected]</span></a></p>
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<div class="heading4" tabindex="0" >
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Page Limitations
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<p class="Normal">All page limitations described in the SF424 Application Guide and the <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11133">Table of Page Limits</a> must be followed.</p>
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<div class="heading4" tabindex="0" >
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Instructions for Application Submission
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<p class="Normal">The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.</p>
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<div class="heading4" tabindex="0" >
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SF424(R&R) Cover
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<p class="Normal">All instructions in the SF424 (R&R) Application Guide must be followed.</p>
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SF424(R&R) Project/Performance Site Locations
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<p class="Normal">All instructions in the SF424 (R&R) Application Guide must be followed.</p>
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<div class="heading4" tabindex="0" >
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SF424(R&R) Other Project Information
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<p class="Normal">All instructions in the SF424 (R&R) Application Guide must be followed.</p>
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<div class="heading4" tabindex="0" >
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SF424(R&R) Senior/Key Person Profile
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<p class="Normal">All instructions in the SF424 (R&R) Application Guide must be followed.</p>
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<p class="Normal"><label class="heading4">R&R or Modular Budget</label> </p>
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<p class="Normal">All instructions in the SF424 (R&R) Application Guide must be followed.</p>
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R&R Subaward Budget
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<p class="Normal">All instructions in the SF424 (R&R) Application Guide must be followed.</p>
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<div class="heading4" tabindex="0" >
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PHS 398 Cover Page Supplement
|
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</div>
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<div>
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<p class="Normal">All instructions in the SF424 (R&R) Application Guide must be followed.</p>
|
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<div class="heading4" tabindex="0" >
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PHS 398 Research Plan
|
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<div>
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<p class="Normal">All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:</p>
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<p class="Normal"><strong>Research Strategy</strong></p>
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|
<p class="Normal">Because of need for timely response to the current health crisis caused by SARS-CoV-2 and COVID-19, a responsive grant application need not have extensive preliminary data, but such data may be included if available. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data.</p>
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<p class="Normal"><strong>Resource Sharing Plan</strong>: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.</p>
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<p class="Normal">The following modifications also apply:</span></p>
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<ul style="margin-left:25px;">
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<li>All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.</li>
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<div class="heading4" tabindex="0" >
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Appendix:
|
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</div>
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<div>
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Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
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<div class="heading4" tabindex="0" >
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PHS Human Subjects and Clinical Trials Information
|
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</div>
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<div>
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<p class="Normal">When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:</p>
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<p class="Normal">If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the <strong>Study Record: PHS Human Subjects and Clinical Trials Information </strong>form or <strong>Delayed Onset Study</strong> record.</p>
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<p class="Normal"><strong>Study Record: PHS Human Subjects and Clinical Trials Information</strong></p>
|
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|
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<p class="Normal">All instructions in the SF424 (R&R) Application Guide must be followed.</p>
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<strong>Delayed Onset Study</strong>
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<p>Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).</span></span></span>All instructions in the SF424 (R&R) Application Guide must be followed.</p>
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|
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PHS Assignment Request Form
|
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</div>
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<div>
|
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<p class="Normal">All instructions in the SF424 (R&R) Application Guide must be followed.</p>
|
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</div>
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<h4 class="heading4">3. Unique Entity Identifier and System for Award Management (SAM)</h4>
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<p class="Normal">See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov</p>
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</div>
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<h4 class="heading4">4. Submission Dates and Times</h4>
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<p class="Normal"><a href="#_Part_1._Overview" style="font-family: Verdana; font-size: 10pt;">Part I. Overview Information</a> contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or </span><a href="https://grants.nih.gov/grants/guide/url_redirect.html?id=82380" style="font-family: Verdana; font-size: 10pt;">Federal holiday</a>, the application deadline is automatically extended to the next business day.</span></p>
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<p>Organizations must submit applications to <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11128" target="_blank">Grants.gov</a> (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11123" target="_blank">eRA Commons</a>, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.</p>
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<p>Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.</p>
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<p>Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.</p>
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</div>
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<h4 class="heading4">5. Intergovernmental Review (E.O. 12372)</h4>
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<p class="Normal">This initiative is not subject to <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11142">intergovernmental review.</a></p>
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<h4 class="heading4">6. Funding Restrictions</h4>
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<p class="Normal">All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11120" style="font-family: Verdana; font-size: 10pt;">NIH Grants Policy Statement</a>.</p>
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<p class="Normal">Pre-award costs are allowable only as described in the <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11143">NIH Grants Policy Statement</a>.</p>
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<h4 class="heading4">7. Other Submission Requirements and Information</h4>
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<p>Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.</p>
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<p>Applicants must complete all required registrations before the application due date. <a href="#_Section_III._Eligibility">Section III. Eligibility Information</a> contains information about registration.</p>
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|
<p>For assistance with your electronic application or for more information on the electronic submission process, visit <a href="https://grants.nih.gov/grants/how-to-apply-application-guide.html" style="color:blue; text-decoration:underline">How to Apply Application Guide</a></span></span></span>. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the <a href="https://grants.nih.gov/grants/how-to-apply-application-guide/due-dates-and-submission-policies/dealing-with-system-issues.htm" style="color:blue; text-decoration:underline">Dealing with System Issues</a> guidance</span></span></span></span>. For assistance with application submission, contact the Application Submission Contacts in <a href="#_Section_VII._Agency">Section VII</a>.</p>
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<p class="Normal" style="margin-left: 25px;"><strong>Important reminders:</strong></p>
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<p class="Normal" style="margin-left: 25px;">All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See <a href="#_Required_Registrations">Section III</a> of this FOA for information on registration requirements.</p>
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<p class="Normal" style="margin-left: 25px;">The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.</p>
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<p class="Normal" style="margin-left: 25px;">See <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11146">more tips</a> for avoiding common errors.</p>
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<p class="Normal">Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by <a href="#_Components_of_Participating">components of participating organizations</a>, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.</p>
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<p class="heading4"><strong>Use of Common Data Elements in NIH-funded Research</strong></p>
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<p class="Normal">Many NIH ICs encourage the use of common data elements (CDEs) in basic, clinical, and applied research, patient registries, and other human subject research to facilitate broader and more effective use of data and advance research across studies. CDEs are data elements that have been identified and defined for use in multiple data sets across different studies. Use of CDEs can facilitate data sharing and standardization to improve data quality and enable data integration from multiple studies and sources, including electronic health records. NIH ICs have identified CDEs for many clinical domains (e.g., neurological disease), types of studies (e.g. genome-wide association studies (GWAS)), types of outcomes (e.g., patient-reported outcomes), and patient registries (e.g., the Global Rare Diseases Patient Registry and Data Repository). NIH has established a Common Data Element (CDE) Resource Portal" (<a href="http://cde.nih.gov/">http://cde.nih.gov/</a>) to assist investigators in identifying NIH-supported CDEs when developing protocols, case report forms, and other instruments for data collection. The Portal provides guidance about and access to NIH-supported CDE initiatives and other tools and resources for the appropriate use of CDEs and data standards in NIH-funded research. Investigators are encouraged to consult the Portal and describe in their applications any use they will make of NIH-supported CDEs in their projects. <strong> </strong></p>
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Post Submission Materials
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<p class="Normal">Applicants are required to follow the instructions for post-submission materials, as described in <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=82299">the policy</a>. Any instructions provided here are in addition to the instructions in the policy.</p>
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<a name="_Section_V._Application"></a><h2 class="heading2">Section V. Application Review Information</h2>
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<h4 class="heading4">1. Criteria</h4>
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<p class="Normal">Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11149">NIH mission</a> are evaluated for scientific and technical merit through the NIH peer review system.</p>
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<p class="Normal">For this particular announcement, note the following:</p>
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<p class="Normal">Because of need for timely response to the current health crisis caused by SARS-CoV-2 and COVID-19, a responsive grant application need not have extensive preliminary data, but such data may be included if available. </span>Accordingly, reviewers will focus their evaluation on the conceptual framework and the potential to significantly advance our knowledge or understanding. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data.</p>
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<p class="Normal">In addition, for applications involving clinical trials: A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.</p>
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Overall Impact
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<p class="Normal">Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).</p>
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Scored Review Criteria
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<p class="Normal">Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.</p>
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<p class="Normal" style="margin-left: 25px;"><label class="heading4">Significance</label> </p>
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<p class="Normal" style="margin-left: 25px;">Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field</span></span></span>?</p>
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<p class="Normal" style="margin-left: 25px;"><strong>In addition, for applications involving clinical trials</strong></p>
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<p class="Normal" style="margin-left: 25px;">Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?</p>
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<p class="Normal" style="margin-left: 25px;"><label class="heading4">Investigator(s)</label> </p>
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<p class="Normal" style="margin-left: 25px;">Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?</p>
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<p class="Normal" style="margin-left: 25px;"><strong>In addition, for applications involving clinical trials</strong></p>
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<p class="Normal" style="margin-left: 25px;">With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?</p>
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<p class="Normal" style="margin-left: 25px;"><label class="heading4">Innovation</label> </p>
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<p class="Normal" style="margin-left: 25px;">Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?</p>
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<p class="Normal" style="margin-left: 25px;"><strong>In addition, for applications involving clinical trials</strong></p>
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<p class="Normal" style="margin-left: 25px;">Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?</p>
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<p class="Normal" style="margin-left: 25px;"><label class="heading4">Approach</label> </p>
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<p class="Normal" style="margin-left: 25px;">Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project</span></span></span>? </span></span></span>Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?</p>
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<p class="Normal" style="margin-left: 25px;"><strong>In addition, for applications involving clinical trials</strong></p>
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<p class="Normal" style="margin-left: 25px;">Does the application adequately address the following, if applicable</p>
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<p class="Normal" style="margin-left: 25px;"><em>Study Design </em></p>
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<p class="Normal" style="margin-left: 25px;">Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified? </p>
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<p class="Normal" style="margin-left: 25px;">Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity? </p>
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<p class="Normal" style="margin-left: 25px;">Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable? </p>
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<p class="Normal" style="margin-left: 25px;"><em>Data Management and Statistical Analysis </em></p>
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<p class="Normal" style="margin-left: 25px;">Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?</p>
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<p class="Normal" style="margin-left: 25px;">If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults)</span></span></span>, justified in terms of the scientific goals and research strategy proposed?</p>
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<p class="Normal" style="margin-left: 25px;"><label class="heading4">Environment</label> </p>
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<p class="Normal" style="margin-left: 25px;">Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?</p>
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<p class="Normal" style="margin-left: 25px;"><strong>In addition, for applications involving clinical trials</strong></p>
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<p class="Normal" style="margin-left: 25px;">If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed? </p>
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<p class="Normal" style="margin-left: 25px;">Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate? </p>
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<p class="Normal" style="margin-left: 25px;">If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?</p>
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<p class="Normal" style="margin-left: 25px;">If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?</p>
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Additional Review Criteria
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<p class="Normal">As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.</p>
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<p class="heading4">Study Timeline </p>
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<p class="Normal"><strong>Specific to applications involving clinical trials</strong></p>
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<p class="Normal">Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?</p>
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<p class="Normal">Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?</p>
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<p class="Normal" style="margin-left: 25px;"><label class="heading4">Protections for Human Subjects</label> </p>
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<p class="Normal" style="margin-left: 25px;">For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.</p>
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<p class="Normal" style="margin-left: 25px;">For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11175">Guidelines for the Review of Human Subjects</a>.</p>
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<p class="Normal" style="margin-left: 25px;"><label class="heading4">Inclusion of Women, Minorities, and Individuals Across the Lifespan</label> </p>
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<p class="Normal" style="margin-left: 25px;">When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults)</span></span></span> to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11174">Guidelines for the Review of Inclusion in Clinical Research</a>.</p>
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<p class="Normal" style="margin-left: 25px;"><label class="heading4">Vertebrate Animals</label> </p>
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<p class="Normal" style="margin-left: 25px;">The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11150">Worksheet for Review of the Vertebrate Animal Section</a>.</p>
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<p class="Normal" style="margin-left: 25px;"><label class="heading4">Biohazards</label> </p>
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<p class="Normal" style="margin-left: 25px;">Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.</p>
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<p class="Normal" style="margin-left: 25px;"><label class="heading4">Resubmissions</label> </p>
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<p class="Normal" style="margin-left: 25px;">Not Applicable</p>
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<p class="Normal" style="margin-left: 25px;"><label class="heading4">Revisions</label> </p>
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Additional Review Considerations
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<p class="Normal">As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.</p>
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<p class="Normal" style="margin-left: 25px;"><label class="heading4">Applications from Foreign Organizations</label> </p>
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<p class="Normal" style="margin-left: 25px;">Not Applicable</p>
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<p class="Normal" style="margin-left: 25px;"><label class="heading4">Select Agent Research</label> </p>
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<p class="Normal" style="margin-left: 25px;">Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).</p>
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<p class="Normal" style="margin-left: 25px;"><label class="heading4">Resource Sharing Plans</label> </p>
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<p class="Normal" style="margin-left: 25px;">Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11151">Data Sharing Plan</a>; (2) <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11152">Sharing Model Organisms</a>; and (3) <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11153"> Genomic Data Sharing Plan (GDS)</a>.</p>
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<p class="Normal" style="margin-left: 25px;"><label class="heading4">Authentication of Key Biological and/or Chemical Resources:</label> </p>
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<p class="Normal" style="margin-left: 25px;">For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.</p>
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<p class="Normal" style="margin-left: 25px;"><label class="heading4">Budget and Period of Support</label> </p>
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<p class="Normal" style="margin-left: 25px;">Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.</p>
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<h4 class="heading4">2. Review and Selection Process</h4>
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<p class="Normal">Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NIDDK, in accordance with <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11154"><font color="#0000ff">NIH peer review policy and procedures</font></a>, using the stated <a href="file:///C:/Users/mckenziene/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/13V4QPZR/Research%20Draft.doc#_1._Criteria"><font color="#0000ff">review criteria</font></a>. Assignment to a Scientific Review Group will be shown in the eRA Commons.</p>
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<p class="Normal">As part of the scientific peer review, all applications will receive a written critique.</p>
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<p class="Normal">Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.</p>
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<a href="//grants.nih.gov/grants/guide/notice-files/NOT-OD-11-064.html">Appeals</a> of initial peer review will not be accepted for applications submitted in response to this FOA.
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<p class="Normal">Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Diabetes and Digestive and Kidney Diseases Advisory Council (NDDKAC). The following will be considered in making funding decisions:</p>
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<ul style="margin-left:25px;">
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<li class="Normal">Scientific and technical merit of the proposed project as determined by scientific peer review.</li>
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<li class="Normal">Availability of funds.</li>
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<li class="Normal">Relevance of the proposed project to program priorities.</li>
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<h4 class="heading4">3. Anticipated Announcement and Award Dates</h4>
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After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11123">eRA Commons</a>. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.
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<p>Information regarding the disposition of applications is available in the <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11156">NIH Grants Policy Statement</a>.</p>
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<a name="_Section_VI._Award"></a><h2 class="heading2">Section VI. Award Administration Information</h2>
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<h4 class="heading4">1. Award Notices</h4>
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If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11157">NIH Grants Policy Statement</a>.
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<p>A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.</p>
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<p>Awardees must comply with any funding restrictions described in <a href="#_5._Funding_Restrictions">Section IV.5. Funding Restrictions</a>. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.</p>
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<p>Any application awarded in response to this FOA will be subject to terms and conditions found on the <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11158">Award Conditions and Information for NIH Grants</a> website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.</p>
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<p class="Normal" style="margin:0in 0in 0.0001pt">Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA. </p>
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<p class="Normal" style="margin:0in 0in 0.0001pt"> </p>
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<p class="Normal">ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (<a href="https://register.clinicaltrials.gov">https://register.clinicaltrials.gov</a>). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see <a href="https://grants.nih.gov/policy/clinical-trials/reporting/index.htm">https://grants.nih.gov/policy/clinical-trials/reporting/index.htm</a> </p>
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<p class="Normal">Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols. </p>
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<p class="Normal">Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at <a href="//grants.nih.gov/grants/policy/hs/data_safety.htm">http://grants.nih.gov/grants/policy/hs/data_safety.htm</a> and in the application instructions (SF424 (R&R) and PHS 398).</p>
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<p class="Normal">Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE). </p>
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<h4 class="heading4">2. Administrative and National Policy Requirements</h4>
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<p class="Normal">All NIH grant and cooperative agreement awards include the <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11120"><i>NIH Grants Policy Statement</i></a> as part of the NoA. For these terms of award, see the <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11157"><i>NIH Grants Policy Statement</i> Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General</a> and <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11159">Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities</a>. More information is provided at <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11158">Award Conditions and Information for NIH Grants</a>.</p>
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<p class="Normal">Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see <a href="https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html">https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html</a> and <a href="https://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html">http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html</a>.</p>
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<p class="Normal">HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.</p>
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<li class="Normal">Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. HHS provides guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see <a href="https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html">https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html</a> and <a href="https://www.lep.gov">https://www.lep.gov</a>. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at <a href="https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53">https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53</a>.</li>
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<ul>
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<li class="Normal">Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see <a href="https://www.hhs.gov/ocr/civilrights/understanding/disability/index.html">http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html</a>.</li>
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<ul>
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<li class="Normal">HHS funded health and education programs must be administered in an environment free of sexual harassment. Please see <a href="https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html">https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html</a>; https://www2.ed.gov/about/offices/list/ocr/docs/shguide.html; and <a href="https://www.eeoc.gov/eeoc/publications/upload/fs-sex.pdf">https://www.eeoc.gov/eeoc/publications/upload/fs-sex.pdf</a>. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see <a href="https://grants.nih.gov/grants/policy/harassment.htm">https://grants.nih.gov/grants/policy/harassment.htm</a>.</li>
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</ul>
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<ul>
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<li class="Normal">Recipients of FFA must also administer their programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws. Collectively, these laws prohibit exclusion, adverse treatment, coercion, or other discrimination against persons or entities on the basis of their consciences, religious beliefs, or moral convictions. Please see <a href="https://www.hhs.gov/conscience/conscience-protections/index.html">https://www.hhs.gov/conscience/conscience-protections/index.html</a> and <a href="https://www.hhs.gov/conscience/religious-freedom/index.html">https://www.hhs.gov/conscience/religious-freedom/index.html</a>.</li>
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</ul>
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<p class="Normal">Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at <a href="https://www.hhs.gov/ocr/about-us/contact-us/index.html">https://www.hhs.gov/ocr/about-us/contact-us/index.html</a> or call 1-800-368-1019 or TDD 1-800-537-7697.</p>
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<p class="Normal">In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.</p>
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Cooperative Agreement Terms and Conditions of Award
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<p class="Normal">Not Applicable</p>
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<h4 class="heading4">3. Reporting</h4>
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When multiple years are involved, awardees will be required to submit the <a href="//grants.nih.gov/grants/rppr/index.htm">Research Performance Progress Report (RPPR)</a> annually and financial statements as required in the <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11161">NIH Grants Policy Statement.</a>
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<p>A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11161">NIH Grants Policy Statement</a>.</p>
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<p>The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11170">www.fsrs.gov</a> on all subawards over $25,000. See the <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11171">NIH Grants Policy Statement</a> for additional information on this reporting requirement.</p>
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<p>In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.</p>
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<a name="_Section_VII._Agency"></a><h2 class="heading2">Section VII. Agency Contacts</h2>
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</div>
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<p>We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.</p>
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Application Submission Contacts
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<p>eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date</span></span></span>, and post-submission issues)</p>
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<p>Finding Help Online: <a href="//grants.nih.gov/support/">http://grants.nih.gov/support/</a> (preferred method of contact)<br />
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Telephone: 301-402-7469 or 866-504-9552 (Toll Free)</p>
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<p>General Grants Information (Questions regarding application instructions, application </span></span></span>processes, and NIH grant resources)<br />
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Email: <a href="/cdn-cgi/l/email-protection#2d6a5f4c43595e64434b426d434445034a425b"><span class="__cf_email__" data-cfemail="0b4c796a657f7842656d644b656263256c647d">[email protected]</span></a> (preferred method of contact)<br />
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Telephone: 301-945-7573</p>
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<p>Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)<br />
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Contact Center Telephone: 800-518-4726<br />
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Email: <a href="/cdn-cgi/l/email-protection#7f0c0a0f0f100d0b3f180d1e110b0c51181009"><span class="__cf_email__" data-cfemail="71020401011e0305311603101f05025f161e07">[email protected]</span></a></p>
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Scientific/Research Contact(s)
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<p class="Normal">Maren R. Laughlin, Ph.D.<br />
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Division of Diabetes, Endocrinology and Metabolic Diseases<br />
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)<br />
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Telephone: 301-594-8802<br />
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Email: <a href="/cdn-cgi/l/email-protection#b2ffd3c0d7dc9cfed3c7d5dadedbdcf2dcdbda9cd5ddc4"><span class="__cf_email__" data-cfemail="470a26352229690b2632202f2b2e2907292e2f69202831">[email protected]</span></a></p>
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<p class="Normal">David Saslowsky, Ph.D.<br />
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Division of Digestive Diseases and Nutrition<br />
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)<br />
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Telephone: 301-594-8876<br />
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Email: <a href="/cdn-cgi/l/email-protection#ca8eabbca3aee499abb9a6a5bdb9a1b38aa4a3a2e4ada5bcf5"><span class="__cf_email__" data-cfemail="84c0e5f2ede0aad7e5f7e8ebf3f7effdc4eaedecaae3ebf2">[email protected]</span></a></p>
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<p class="Normal">Bonnie Burgess-Beusse, Ph.D.<br />
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Division of Digestive Diseases and Nutrition<br />
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)<br />
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Telephone: 301-594-4726<br />
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Email: <a href="/cdn-cgi/l/email-protection#27654849494e4209655255404254540a65425254544267494e4f09404851"><span class="__cf_email__" data-cfemail="c082afaeaea9a5ee82b5b2a7a5b3b3ed82a5b5b3b3a580aea9a8eea7afb6">[email protected]</span></a></p>
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<p class="Normal">Ivonne Schulman, M.D.<br />
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Division of Kidney, Urologic, and Hematologic Diseases<br />
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)<br />
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Telephone: 301-435-3350<br />
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Email: <a href="/cdn-cgi/l/email-protection#e1a8978e8f8f84cfb28289948d8c808fa18f8889cf868e97"><span class="__cf_email__" data-cfemail="c089b6afaeaea5ee93a3a8b5acada1ae80aea9a8eea7afb6">[email protected]</span></a></p>
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<p class="Normal"></p>
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<p class="Normal">Afshin Parsa, M.D.<br />
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Division of Kidney, Urologic, and Hematologic Diseases<br />
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)<br />
|
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Telephone: 301-827-1375<br />
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Email: <a href="/cdn-cgi/l/email-protection#c180a7b2a9a8afef91a0b3b2a081afa8a9efa6aeb7"><span class="__cf_email__" data-cfemail="f5b493869d9c9bdba594878694b59b9c9ddb929a83">[email protected]</span></a></p>
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</div>
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Peer Review Contact(s)
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<p class="Normal">Xiaodu Guo, Ph.D.<br />
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)<br />
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Telephone: 301-594-4719<br />
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Email: <a href="/cdn-cgi/l/email-protection#6403110b1c240a0d00000f4a0a0d0c4a030b12"><span class="__cf_email__" data-cfemail="f99e8c9681b997909d9d92d7979091d79e968f">[email protected]</span></a></p>
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</div>
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Financial/Grants Management Contact(s)
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</div>
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<div>
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<p class="Normal">Todd Le<br />
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)<br />
|
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Telephone: 301-594-7794<br />
|
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Email: <a href="/cdn-cgi/l/email-protection#88c4eddcc8edf0fcfae9a6e6e1ecece3a6e6e1e0a6efe7fe"><span class="__cf_email__" data-cfemail="a4e8c1f0e4c1dcd0d6c58acacdc0c0cf8acacdcc8ac3cbd2">[email protected]</span></a></p>
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</div>
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<a name="_Section_VIII._Other"></a><h2 class="heading2">Section VIII. Other Information</h2>
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<p class="Normal">Recently issued trans-NIH <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11163">policy notices</a> may affect your application submission. A full list of policy notices published by NIH is provided in the <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11164">NIH Guide for Grants and Contracts</a>. All awards are subject to the terms and conditions, cost principles, and other considerations described in the <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11120">NIH Grants Policy Statement</a>.</p>
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Authority and Regulations
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</div>
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<div>
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<p class="Normal">Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.</p>
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<HR>
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<A HREF="/grants/guide/WeeklyIndex.cfm?07-10-20">Weekly TOC for this Announcement</A><br>
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<A HREF="/grants/guide/index.html">NIH Funding Opportunities and Notices</A>
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<div class="col-md-4"> <a href="/grants/oer.htm"><img src="/images7/nih-oer-logo.jpg" alt="NIH Office of Extramural Research Logo" usemap="#Map2" border="0"></a>
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<div style="float:left; padding: 5 5 5 70"> <a href="https://www.hhs.gov/"><img src="/images7/dhhs_sm.gif" width="36" height="37" border="0" alt="Department of Health and Human Services (HHS) - Home Page" long desc="Logo, circular in shape, depicting an American eagle in-flight with stylized profiles of human faces appearing on the trailing edge of the wings. The perimeter of the logo is encircled with the words 'Department of Health and Human Services U S A'"></a></div>
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<div style="padding: 5 5 5 5;">Department of Health<br>
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and Human Services (HHS)</div>
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