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<HTML lang="en-US">
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<TITLE>Expired RFA-HD-25-009: Using Archived Data and Specimen Collections to Advance Maternal and Pediatric HIV/AIDS Research (R21 - Clinical Trial Not Allowed)</TITLE>
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<META NAME="description" CONTENT="NIH Funding Opportunities and Notices in the NIH Guide for Grants and Contracts: Using Archived Data and Specimen Collections to Advance Maternal and Pediatric HIV/AIDS Research (R21 - Clinical Trial Not Allowed) RFA-HD-25-009. NICHD">
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<META NAME="Keywords" CONTENT="RFA-HD-25-009: Using Archived Data and Specimen Collections to Advance Maternal and Pediatric HIV/AIDS Research (R21 - Clinical Trial Not Allowed)">
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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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<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>
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<div>
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<div data-element-id="191532" data-element-has-label="false" data-element-required="false" data-element-has-value="true" data-section-code="OI" data-element-type="TEXT">
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<a name="_Part 1. Overview Information"></a><h1 class="heading1">Part 1. Overview Information</h1>
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<div class="row" data-index="2">
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<div class="col-md-4 datalabel" tabindex="0" data-element-id="191533" data-element-required="true" data-element-has-value="true" data-section-code="OI" data-element-type="TEXT">
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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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Components of Participating Organizations
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<div class=" col-md-8 datacolumn">
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<p>Eunice Kennedy Shriver National Institute of Child Health and Human Development (<a href="https://www.nichd.nih.gov/" target="_blank" rel="noreferrer">NICHD</a>)
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<p>National Institute of Mental Health (<a href="https://www.nimh.nih.gov/index.shtml" target="_blank" rel="noreferrer">NIMH</a>)
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</p>
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<div class="col-md-4 datalabel" tabindex="0" data-element-id="191537" data-element-required="true" data-element-has-value="true" data-section-code="OI" data-element-type="LINKED_ELEMENT">
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Funding Opportunity Title
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</div>
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<div class=" col-md-8 datacolumn">
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<span class="title">Using Archived Data and Specimen Collections to Advance Maternal and Pediatric HIV/AIDS Research (R21 - Clinical Trial Not Allowed)</span>
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</div>
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<div class="col-md-4 datalabel" tabindex="0" data-element-id="191538" data-element-required="true" data-element-has-value="true" data-section-code="OI" data-element-type="TEXT">
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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 class="Normal"><a href="//grants.nih.gov/grants/funding/ac_search_results.htm?text_curr=r21&Search.x=0&Search.y=0&Search_Type=Activity">R21</a> Exploratory/Developmental Research Grant</p>
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<div class="col-md-4 datalabel" tabindex="0" data-element-id="191539" data-element-required="true" data-element-has-value="true" data-section-code="OI" data-element-type="LINKED_ELEMENT">
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Announcement Type
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<div class=" col-md-8 datacolumn">
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Reissue of
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<a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-HD-24-006.html" target="_blank" rel="noreferrer">RFA-HD-24-006</a>
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<br/>
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<div class="col-md-4 datalabel" tabindex="0" data-element-id="191540" data-element-required="true" data-element-has-value="true" data-section-code="OI" data-element-type="TEXT">
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Related Notices
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<div class=" col-md-8 datacolumn">
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<ul>
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<li class="Normal"><strong>August 31, 2022</strong>- Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice <a href="https://grants.nih.gov/grants/guide/notice-files/not-od-22-198.html">NOT-OD-22-198</a>.</li>
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<li class="Normal"><strong>August 5, 2022</strong>- Implementation Details for the NIH Data Management and Sharing Policy. See Notice <a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-22-189.html">NOT-OD-22-189</a>.</li>
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<div class="col-md-4 datalabel" tabindex="0" data-element-id="191541" data-element-required="true" data-element-has-value="true" data-section-code="OI" data-element-type="LINKED_ELEMENT">
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Funding Opportunity Number (FON)
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</div>
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<div class=" col-md-8 datacolumn">
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<span class="noticenum">RFA-HD-25-009</span>
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<div class="row" data-index="11">
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<div class="col-md-4 datalabel" tabindex="0" data-element-id="191542" data-element-required="true" data-element-has-value="true" data-section-code="OI" data-element-type="LINKED_ELEMENT">
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Companion Funding Opportunity
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<div class=" col-md-8 datacolumn">
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None
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<div class="col-md-4 datalabel" tabindex="0" data-element-id="191543" data-element-required="true" data-element-has-value="true" data-section-code="OI" data-element-type="TEXT">
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Number of Applications
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<div class=" col-md-8 datacolumn">
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<p>See Section III. 3. Additional Information on Eligibility.</p>
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<div class="col-md-4 datalabel" tabindex="0" data-element-id="191544" data-element-required="true" data-element-has-value="true" data-section-code="OI" data-element-type="LINKED_ELEMENT">
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Assistance Listing Number(s)
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</div>
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<div class=" col-md-8 datacolumn">
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93.865, 93.242
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</div>
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<div class="row" data-index="14">
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<div class="col-md-4 datalabel" tabindex="0" data-element-id="191545" data-element-required="true" data-element-has-value="true" data-section-code="OI" data-element-type="TEXT">
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Funding Opportunity Purpose
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</div>
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<div class=" col-md-8 datacolumn">
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<p>The purpose of this Notice of Funding Opportunity (NOFO) is to utilize archived HIV/AIDS data and biospecimen collections to generate new research questions and findings related to epidemiology, pathogenesis, treatment, prevention, clinical manifestations, and HIV-associated co-infections in maternal, pediatric, and adolescent populations.</p>
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</div>
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<div data-element-id="191546" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="KD" data-element-type="TEXT">
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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="col-md-4 datalabel" tabindex="0" data-element-id="191547" data-element-required="true" data-element-has-value="true" data-section-code="KD" data-element-type="DATE">
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Posted Date
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</div>
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<div class=" col-md-8 datacolumn">
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April 25, 2024
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</div>
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<div class="row" data-index="17">
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<div class="col-md-4 datalabel" tabindex="0" data-element-id="191548" data-element-required="true" data-element-has-value="true" data-section-code="KD" data-element-type="LINKED_ELEMENT">
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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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June 24, 2024
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</div>
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</div>
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<div class="row" data-index="18">
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<div class="col-md-4 datalabel" tabindex="0" data-element-id="191549" data-element-required="true" data-element-has-value="true" data-section-code="KD" data-element-type="TEXT">
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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">30 days prior to application due date</p>
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<div data-element-id="191550" data-element-has-label="false" data-element-required="false" data-element-has-value="true" data-section-code="KD" data-element-type="LINKED_ELEMENT">
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<th scope="col" colspan="3" style="border:2px solid #bcbcbc;" class="text-center">Application Due Dates</th>
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<th scope="col" colspan="3" style="border:2px solid #bcbcbc;" class="text-center">Review and Award Cycles</th>
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</tr>
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<th scope="col" style="width:16.66%;border-left:2px solid #bcbcbc;" class="text-center">New</th>
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<th scope="col" style="width:16.66%" class="text-center">Renewal / Resubmission / Revision (as allowed)</th>
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<th scope="col" style="width:16.66%;border-right:2px solid #bcbcbc;" class="text-center">AIDS - New/Renewal/Resubmission/Revision, as allowed</th>
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<th scope="col" style="width:16.66%" class="text-center">Scientific Merit Review</th>
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<th scope="col" style="width:16.66%" class="text-center">Advisory Council Review</th>
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<th scope="col" style="width:16.66%;border-right:2px solid #bcbcbc;" class="text-center">Earliest Start Date</th>
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July 24, 2024
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Not Applicable
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<td>
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July 24, 2024
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<td>November 2024</td>
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<td> January 2025
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<td>April 2025</td>
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<div data-element-id="191551" data-element-has-label="false" data-element-required="false" data-element-has-value="false" data-section-code="KD" data-element-type="TEXT">
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<div data-element-id="191552" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="KD" data-element-type="TEXT">
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<p class="Normal">All applications are due by 5:00 PM local time of applicant organization. </p>
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<p class="Normal">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 data-element-id="191553" data-element-has-label="false" data-element-required="false" data-element-has-value="false" data-section-code="KD" data-element-type="CHECKBOX">
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<div data-element-id="191554" data-element-has-label="false" data-element-required="false" data-element-has-value="false" data-section-code="KD" data-element-type="TEXT">
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<div data-element-id="191555" data-element-has-label="false" data-element-required="false" data-element-has-value="false" data-section-code="KD" data-element-type="TEXT">
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<div data-element-id="191556" data-element-has-label="false" data-element-required="false" data-element-has-value="false" data-section-code="KD" data-element-type="TEXT">
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</div>
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<div data-element-id="191557" data-element-has-label="false" data-element-required="false" data-element-has-value="false" data-section-code="KD" data-element-type="TEXT">
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<div class="col-md-4 datalabel" tabindex="0" data-element-id="191558" data-element-required="true" data-element-has-value="true" data-section-code="KD" data-element-type="LINKED_ELEMENT">
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Expiration Date
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<div class=" col-md-8 datacolumn">
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July 25, 2024
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<div class="col-md-4 datalabel" tabindex="0" data-element-id="191559" data-element-required="true" data-element-has-value="true" data-section-code="KD" data-element-type="TEXT">
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Due Dates for E.O. 12372
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</div>
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<div class=" col-md-8 datacolumn">
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<p class="Normal">Not Applicable</p>
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Required Application Instructions
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</div>
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<div data-element-id="191560" data-element-has-label="true" data-element-required="true" data-element-has-value="true" data-section-code="KD" data-element-type="TEXT">
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<p class="Normal">It is critical that applicants follow the instructions in the Research (R) Instructions in the <a href="https://grants.nih.gov/grants/guide/url_redirect.php?id=82400">How to Apply - Application Guide</a>, except where instructed to do otherwise (in this NOFO or in a Notice from <a href="//grants.nih.gov/grants/guide/url_redirect.php?id=11164">NIH Guide for Grants and Contracts</a>).</p>
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<p class="Normal">Conformance to all requirements (both in the <a href="https://grants.nih.gov/grants/guide/url_redirect.php?id=82400">How to Apply - Application Guide</a> and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the <a href="https://grants.nih.gov/grants/guide/url_redirect.php?id=82400">How to Apply - Application Guide</a> as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the <a href="https://grants.nih.gov/grants/guide/url_redirect.php?id=82400">How to Apply - Application Guide</a>, follow the program-specific instructions.</p>
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<p class="Normal"><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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background-color: #4CAF50; /* Green */
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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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.important {
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color: #F00;
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font-weight: bold;
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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 Information">Part 1. Overview Information</a></div><div class="toc-link P_SingleIndent"><a href="#_Key Dates">Key Dates</a></div><div class="toc-link"><a href="#_Part 2. Full Text of Announcement">Part 2. Full Text of Announcement</a></div><div class="toc-link P_SingleIndent"><a href="#_Section I. Notice of Funding Opportunity Description">Section I. Notice of Funding Opportunity Description</a></div><div class="toc-link P_SingleIndent"><a href="#_Section II. Award Information">Section II. Award Information</a></div><div class="toc-link P_SingleIndent"><a href="#_Section III. Eligibility Information">Section III. Eligibility Information</a></div><div class="toc-link P_SingleIndent"><a href="#_Section IV. Application and Submission Information">Section IV. Application and Submission Information</a></div><div class="toc-link P_SingleIndent"><a href="#_Section V. Application Review Information">Section V. Application Review Information</a></div><div class="toc-link P_SingleIndent"><a href="#_Section VI. Award Administration Information">Section VI. Award Administration Information</a></div><div class="toc-link P_SingleIndent"><a href="#_Section VII. Agency Contacts">Section VII. Agency Contacts</a></div><div class="toc-link P_SingleIndent"><a href="#_Section VIII. Other Information">Section VIII. Other Information</a></div>
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<div data-element-id="191562" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="FOD" data-element-type="TEXT">
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<a name="_Part 2. Full Text of Announcement"></a><h1 class="heading1">Part 2. Full Text of Announcement</h1>
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</div>
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<div data-element-id="191563" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="FOD" data-element-type="TEXT">
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<a name="_Section I. Notice of Funding Opportunity Description"></a><h2 class="heading2">Section I. Notice of Funding Opportunity Description</h2>
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</div>
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<div data-element-id="191564" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="FOD" data-element-type="TEXT">
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<p>To maximize the scientific potential of valuable maternal, pediatric, and adolescent HIV resources, secondary analyses of archived data and the use of biospecimen collections will allow interested applicants to go beyond original hypotheses to answer new research questions.</p><p>The <a href="https://www.nichd.nih.gov/about/org/der/branches/mpidb">Maternal and Pediatric Infectious Disease Branch (MPIDB)</a> has a well-established role in the collection and archiving of maternal, pediatric, and adolescent HIV/AIDS data and specimens. The NICHD <a href="https://dash.nichd.nih.gov/">Data and Specimen Hub (DASH)</a> stores and provides access to phenotypic data linked to biospecimen collections, and access to additional <a href="https://dash.nichd.nih.gov/Resource/LinksToOtherArchives">External Archives for other NICHD Funded Studies</a>. Collections include research on HIV/AIDS, pharmacology, pregnancy, and infant care, as well as other topics across various life stages, domestic and international settings, and study types. Access to DASH is free and publicly available.</p><p>Other data and specimen collections, and resources, relevant for this NOFO, include but are not limited to the following:</p><ul><li><a href="https://gcc02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fimpaactnetwork.org%2F&data=05%7C01%7Clori.scott-sheldon%40nih.gov%7Caf8897ef88c94db463fe08da9ce501dd%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C637994804633894413%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=tplXIgVy98gg7Cs5b%2Bqno4Y4NXd5ZzFz1SY6jqPlRoU%3D&reserved=0">International Maternal and Pediatric Adolescent AIDS Clinical Trials Network</a> (IMPAACT), a domestic and international clinical trials network for HIV in infants, children, adolescents and pregnant women;</li><li><a href="https://www.atnconnect.org/" Title="Link to Non-U.S. Government Site">Adolescent Medicine Trials Networks for HIV/AIDS Interventions</a> (ATN), a domestic research program studying the HIV prevention cascade and the HIV treatment/care cascade;</li><li><a href="https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fphacsstudy.org%2F&data=05%7C01%7Clori.scott-sheldon%40nih.gov%7Caf8897ef88c94db463fe08da9ce501dd%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C637994804633894413%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=swEv2yPBijOEJt7kuZXuZ7IijuaVzwg7MFywvIjt914%3D&reserved=0">Pediatric HIV/AIDS Cohort Study</a> (PHACS), which conducts domestic research looking at long-term safety of antiretrovirals (ARV) medications taken during pregnancy among women living with HIV (WLHIV), long-term effects of HIV and its therapy in youth with perinatally acquired HIV, and other studies addressing the impact of HIV exposure in uninfected infants, children, and youth.</li><li>The <a href="https://www.nichd.nih.gov/about/org/der/branches/opptb/mprint">Maternal and Pediatric Precision in Therapeutics (MPRINT) Hub</a> which focuses on aggregating, presenting, and expanding the available knowledge, tools, and expertise in maternal and pediatric therapeutics research.</li><li>The International Epidemiological Databases to Evaluate AIDS (<a href="https://www.iedea.org/" Title="Link to Non-U.S. Government Site">IeDEA</a>), an international research consortium collecting observational, clinic-based data from over 2.2 million people living with HIV and at risk for HIV across 44 countries since 2006, which includes the Adolescent and Young Adult Network of IeDEA (<a href="https://www.iedea.org/working-groups/adolescent-and-young-adult-network-of-iedea-ayani/" Title="Link to Non-U.S. Government Site">AYANI</a>) cohort representing adolescents and young adults living with HIV.</li><li>The <a href="https://www.nichdclinicalstudies.org/SitePages/NISDI.aspx" Title="Link to Non-U.S. Government Site">NICHD International Site Development Initiative (NISDI)</a>, which describes the characteristics of pregnant women living with HIV and their HIV-exposed infants in Latin America and the Caribbean and other studies of WLHIV.</li><li>The <a href="https://statepi.jhsph.edu/mwccs/" Title="Link to Non-U.S. Government Site">Multicenter AIDS Cohort Study (MACS) / Women’s Interagency HIV Study (WIHS) Combined Cohort Study (MACS/WIHS-CSS)</a>, which studies chronic health conditions that affect people living with HIV</li></ul><p>Use of other data and specimen collections must follow study and network-specific requirements for secondary analyses. Letters of support and/or commitment must be provided from collaborators, key personnel, institutions, or other significant contributors for any data sets, resources, biospecimen collections, or partnerships required for the proposed project. Applicants are encouraged to incorporate innovative data science approaches to augment existing HIV epidemiological data. </p><p><strong>Areas of Research Interest:</strong></p><ul><li>Investigating responses to antiretroviral (ARV) regimens in mothers, infants, and adolescents for the prevention of HIV transmission;</li><li>Examining the role of the myeloid lineage in HIV pathology and persistence;</li><li>Exploring the pathogenesis and long-term effects of HIV infection or exposure in infants, children, and adolescents and associated co-infections such as malaria, tuberculosis, SARS-CoV-2, cytomegalovirus, and Epstein-Barr virus;</li><li>Identifying biomarkers of pediatric HIV disease progression that predict treatment response(s);</li><li>Exploring approaches for achieving viral suppression rates including the use of long acting injectables in youth living with HIV (YLHIV);</li><li>Examining the linkages between behavioral, clinical, social and structural determinants related to adolescent and young adult HIV screening, diagnosis, and treatment;</li><li>Understanding vaccine hesitancy including generational impacts, such as attitudes and adherence to vaccination schedules in individuals living with HIV;</li><li>Identify critical multi-level psychosocial factors that influence engagement in HIV care for adolescents including their impact on the transition to adult HIV care;</li><li>Use data science approaches to determine the potential differential impact of HIV interventions on outcomes along the HIV care and prevention continua for key youth populations and other youth who exhibit greater disparities with regards to HIV-related health outcomes.</li></ul><h4>NICHD Data Sharing Expectations </h4><p>The <a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-013.html">NIH Policy for Data Management and Sharing (Policy)</a> expects researchers maximize the sharing of scientific data and data be accessible as soon as possible and no later than the time of an associated publication or the end of the award period, whichever comes first. NIH requires all applications submitted in response to this NOFO to include a Data Management and Sharing Plan (DMS Plan). The Plan is expected to address the Elements as described in Supplemental Information to the NIH Policy for Data Management and Sharing: Elements of an NIH Data Management and Sharing Plan (<a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-014.htm">NOT-OD-21-014)</a>. The Plan will be reviewed and approved by NIH Program Staff prior to award. Recipients will be required to comply with their approved Plan and any approved updates. For human data, NICHD encourages the use of the Data and Specimen Hub (DASH), a centralized resource for researchers to store and access de-identified data from studies funded by NICHD. Information about DASH may be obtained at <a href="https://dash.nichd.nih.gov/">https://dash.nichd.nih.gov/</a>. For projects generating large-scale human genetic data, applicants should provide a Provisional or Institutional Certification specifying whether the individual-level data can be shared through an NIH approved repository, such as dbGaP and the Sequence Read Archive, in line with the <a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-124.html">NIH Genomic Data Sharing Policy</a>. If use of DASH is not feasible, NICHD expects awardees to share data through other equivalent broad-sharing data repositories. Researchers should submit information about the location and availability of data in other repositories to the DASH Catalog, if applicable.</p><p>For applications that aim to co-analyze already shared data with data that have not yet been shared with the broader research community, applicants should be aware that such primary data should be shared with the broad research community. Additional information on the Data Management and Sharing Policy is available on the <a href="https://www.nichd.nih.gov/about/org/od/odss#resources">NICHD Office of Data Science and Sharing website</a>. </p>
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<div data-element-id="191565" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="FOD" data-element-type="TEXT">
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<p>See Section VIII. Other Information for award authorities and regulations.</p>
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</div>
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<div data-element-id="191567" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="AI" data-element-type="TEXT">
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<a name="_Section II. Award Information"></a><h2 class="heading2">Section II. Award Information</h2>
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</div>
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<div class="row" data-index="37">
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<div class="col-md-4 datalabel" tabindex="0" data-element-id="191568" data-element-required="true" data-element-has-value="true" data-section-code="AI" data-element-type="TEXT">
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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 financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.</p>
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</div>
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</div>
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<div class="row" data-index="38">
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<div class="col-md-4 datalabel" tabindex="0" data-element-id="191569" data-element-required="true" data-element-has-value="true" data-section-code="AI" data-element-type="LINKED_ELEMENT">
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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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<br>
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</div>
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</div>
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<div class="row" data-index="40">
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<div class="col-md-push-4 col-md-8 datacolumn">
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<p class="Normal">The <a href="//grants.nih.gov/grants/guide/url_redirect.php?id=11116">OER Glossary</a> and the <a href="https://grants.nih.gov/grants/guide/url_redirect.php?id=82400">How to Apply - Application Guide</a> provide details on these application types. Only those application types listed here are allowed for this NOFO.</p>
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<div class="row" data-index="41">
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<div class="col-md-4 datalabel" tabindex="0" data-element-id="191572" data-element-required="false" data-element-has-value="true" data-section-code="AI" data-element-type="TEXT">
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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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<p class="Normal">Not Allowed: Only accepting applications that do not propose clinical trials.</p>
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</div>
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</div>
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<div class="row" data-index="42">
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<div class="col-md-push-4 col-md-8 datacolumn">
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<p class="Normal"><a href="https://grants.nih.gov/grants/guide/url_redirect.php?id=82370">Need help determining whether you are doing a clinical trial?</a></p>
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</div>
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</div>
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<div class="row" data-index="43">
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<div class="col-md-4 datalabel" tabindex="0" data-element-id="191574" data-element-required="true" data-element-has-value="true" data-section-code="AI" data-element-type="TEXT">
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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>The following NIH components intend to commit the following amounts in FY 2025. </p><p>NICHD, $900,000, 3-4 awards.</p><p>NIMH, $200,000, 1 award</p>
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</div>
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</div>
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<div class="row" data-index="44">
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<div class="col-md-4 datalabel" tabindex="0" data-element-id="191575" data-element-required="true" data-element-has-value="true" data-section-code="AI" data-element-type="TEXT">
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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">Direct costs are limited to $275,000 over a two-year period, with no more than $200,000 in direct costs in any year.</p>
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</div>
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</div>
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<div class="row" data-index="45">
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<div class="col-md-4 datalabel" tabindex="0" data-element-id="191576" data-element-required="true" data-element-has-value="true" data-section-code="AI" data-element-type="TEXT">
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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 2 years.</p>
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</div>
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<!--This variable defines that we need to start a new row. -->
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<div data-element-id="191577" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="AI" data-element-type="TEXT">
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<p class="Normal">NIH grants policies as described in the <a href="//grants.nih.gov/grants/guide/url_redirect.php?id=11120">NIH Grants Policy Statement</a> will apply to the applications submitted and awards made from this NOFO.</p>
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<div data-element-id="191578" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="EI" data-element-type="TEXT">
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<a name="_Section III. Eligibility Information"></a><h2 class="heading2">Section III. Eligibility Information</h2>
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<div data-element-id="191579" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="EI" data-element-type="TEXT">
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<p class="heading4">1. Eligible Applicants</p>
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<div class="heading4" tabindex="0" data-element-id="191580" data-element-required="true" data-element-has-value="true" data-section-code="EI" data-element-type="TEXT">
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Eligible Organizations
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</div>
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<div data-element-id="191580" data-element-has-label="true" data-element-required="true" data-element-has-value="true" data-section-code="EI" data-element-type="TEXT">
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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 data-element-id="191581" data-element-has-label="false" data-element-required="false" data-element-has-value="true" data-section-code="EI" data-element-type="TEXT">
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<p class="Normal">Federal Governments</p>
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<ul>
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<li class="Normal">Eligible Agencies of the Federal Government</li>
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<li class="Normal">U.S. Territory or Possession</li>
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</ul>
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</div>
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<div data-element-id="191582" data-element-has-label="false" data-element-required="false" data-element-has-value="true" data-section-code="EI" data-element-type="TEXT">
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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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<li class="Normal">Non-domestic (non-U.S.) Entities (Foreign Organizations)</li>
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</ul>
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</div>
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<div data-element-id="191583" data-element-has-label="false" data-element-required="false" data-element-has-value="false" data-section-code="EI" data-element-type="TEXT">
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</div>
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<div class="heading4" tabindex="0" data-element-id="191584" data-element-required="true" data-element-has-value="false" data-section-code="EI" data-element-type="TEXT">
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Foreign Organizations
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</div>
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<div data-element-id="191584" data-element-has-label="true" data-element-required="true" data-element-has-value="false" data-section-code="EI" data-element-type="TEXT">
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</div>
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<div data-element-id="191585" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="EI" data-element-type="RADIO_BUTTON">
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<p class="Normal">Non-domestic (non-U.S.) Entities (Foreign Organizations) <strong>are </strong>eligible to apply.</p>
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</div>
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<div data-element-id="191586" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="EI" data-element-type="RADIO_BUTTON">
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<p>Non-domestic (non-U.S.) components of U.S. Organizations <strong>are </strong>eligible to apply.</p>
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</div>
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<div data-element-id="191587" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="EI" data-element-type="RADIO_BUTTON">
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<p>Foreign components, as <a href="//grants.nih.gov/grants/guide/url_redirect.php?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" data-element-id="191588" data-element-required="true" data-element-has-value="true" data-section-code="EI" data-element-type="TEXT">
|
|
Required Registrations
|
|
</div>
|
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|
<div data-element-id="191588" data-element-has-label="true" data-element-required="true" data-element-has-value="true" data-section-code="EI" data-element-type="TEXT">
|
|
<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 <a href="https://grants.nih.gov/grants/guide/url_redirect.php?id=82400">How to Apply - Application Guide</a> to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference <a href="//grants.nih.gov/grants/guide/url_redirect.php?id=82423">NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications</a> for additional information</p>
|
|
|
|
<ul>
|
|
<li class="Normal"><a href="https://grants.nih.gov/grants/guide/url_redirect.php?id=82390">System for Award Management (SAM) –</a> Applicants must complete and maintain an active registration, <strong>which requires renewal at least annually</strong>. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
|
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|
|
<ul>
|
|
<li class="Normal"><a href="//grants.nih.gov/grants/guide/url_redirect.php?id=11176">NATO Commercial and Government Entity (NCAGE) Code</a> – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.</li>
|
|
<li class="Normal">Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.</li>
|
|
</ul>
|
|
</li>
|
|
<li class="Normal"><a href="https://grants.nih.gov/grants/guide/url_redirect.php?id=11123">eRA Commons</a> - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.</li>
|
|
<li class="Normal"><a href="//grants.nih.gov/grants/guide/url_redirect.php?id=82300">Grants.gov</a> – Applicants must have an active 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>
|
|
</div>
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<div class="heading4" tabindex="0" data-element-id="191589" data-element-required="true" data-element-has-value="true" data-section-code="EI" data-element-type="TEXT">
|
|
Eligible Individuals (Program Director/Principal Investigator)
|
|
</div>
|
|
|
|
<div data-element-id="191589" data-element-has-label="true" data-element-required="true" data-element-has-value="true" data-section-code="EI" data-element-type="TEXT">
|
|
<p class="Normal">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 their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities<a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-22-019.html">,</a> <a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-22-019.html">NOT-OD-22-019</a>.</p>
|
|
|
|
<p class="Normal">For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the <a href="https://grants.nih.gov/grants/guide/url_redirect.php?id=82400">How to Apply - Application Guide</a>.</p>
|
|
</div>
|
|
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|
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|
|
<div data-element-id="191590" data-element-has-label="false" data-element-required="false" data-element-has-value="false" data-section-code="EI" data-element-type="TEXT">
|
|
|
|
</div>
|
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|
|
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|
|
<div data-element-id="191591" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="EI" data-element-type="TEXT">
|
|
<p class="heading4">2. Cost Sharing</p>
|
|
|
|
<p class="Normal">This NOFO does not require cost sharing as defined in the <a href="//grants.nih.gov/grants/guide/url_redirect.php?id=11126">NIH Grants Policy Statement NIH Grants Policy Statement Section 1.2 Definition of Terms.</a></p>
|
|
</div>
|
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|
|
<div data-element-id="191592" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="EI" data-element-type="TEXT">
|
|
<p class="heading4">3. Additional Information on Eligibility</p>
|
|
|
|
<p class="heading4">Number of Applications</p>
|
|
</div>
|
|
|
|
|
|
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|
|
|
|
|
<div data-element-id="191593" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="EI" data-element-type="TEXT">
|
|
<p class="Normal">Applicant organizations may submit more than one application, provided that each application is scientifically distinct.</p>
|
|
|
|
<p class="Normal">The NIH will not accept duplicate or highly overlapping applications under review at the same time, per <a href="//grants.nih.gov/grants/guide/url_redirect.php?id=82415">NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application</a>. This means that the NIH will not accept:</p>
|
|
|
|
<ul>
|
|
<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>
|
|
<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>
|
|
<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/url_redirect.php?id=82423">NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications</a>).</li>
|
|
</ul>
|
|
</div>
|
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|
|
<div data-element-id="191594" data-element-has-label="false" data-element-required="false" data-element-has-value="false" data-section-code="EI" data-element-type="TEXT">
|
|
|
|
</div>
|
|
|
|
|
|
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|
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|
|
<div data-element-id="191595" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT">
|
|
<a name="_Section IV. Application and Submission Information"></a><h2 class="heading2">Section IV. Application and Submission Information</h2>
|
|
</div>
|
|
|
|
|
|
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|
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|
|
<div data-element-id="191596" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT">
|
|
<p class="heading4">1. Requesting an Application Package</p>
|
|
|
|
<p class="Normal">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 are available in <a href="#_Required_Application_Instructions">Part 1</a> of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.</p>
|
|
</div>
|
|
|
|
|
|
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|
|
<div data-element-id="191597" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT">
|
|
<p class="heading4">2. Content and Form of Application Submission</p>
|
|
|
|
<p class="Normal">It is critical that applicants follow the instructions in the Research (R) Instructions in the <a href="https://grants.nih.gov/grants/guide/url_redirect.php?id=82400">How to Apply - Application Guide</a> except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the <a href="https://grants.nih.gov/grants/guide/url_redirect.php?id=82400">How to Apply - Application Guide</a> is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.</p>
|
|
</div>
|
|
|
|
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|
|
|
<div data-element-id="191598" data-element-has-label="false" data-element-required="false" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT">
|
|
<h4>Letter of Intent</h4><p>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><p>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><ul><li>Descriptive title of proposed activity</li><li>Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)</li><li>Names of other key personnel</li><li>Participating institution(s)</li><li>Data and/or biospecimen collection(s) to be used</li><li>Number and title of this funding opportunity</li></ul><p>The letter of intent should be sent to:</p><p>Eric Lorenzo, PhD<br><i>Eunice Kennedy Shriver</i> National Institute of Child Health and Human Development (NICHD)<br>Telephone: 301-443-4993<br>Email: <a href="/cdn-cgi/l/email-protection#4520372c266b292a37202b3f2a052b2c2d6b222a33"><span class="__cf_email__" data-cfemail="99fcebf0fab7f5f6ebfcf7e3f6d9f7f0f1b7fef6ef">[email protected]</span></a></p>
|
|
</div>
|
|
|
|
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|
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|
|
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|
|
<div data-element-id="191599" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT">
|
|
<p class="heading4">Page Limitations</p>
|
|
|
|
<p class="Normal">All page limitations described in the <a href="https://grants.nih.gov/grants/guide/url_redirect.php?id=82400">How to Apply – Application Guide</a> and the <a href="https://grants.nih.gov/grants/guide/url_redirect.php?id=61134">Table of Page Limits</a> must be followed.</p>
|
|
</div>
|
|
|
|
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|
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|
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|
|
|
|
|
<div data-element-id="191600" data-element-has-label="false" data-element-required="false" data-element-has-value="false" data-section-code="ASI" data-element-type="TEXT">
|
|
|
|
</div>
|
|
|
|
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|
|
<div class="heading4" tabindex="0" data-element-id="191601" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT">
|
|
Instructions for Application Submission
|
|
</div>
|
|
|
|
<div data-element-id="191601" data-element-has-label="true" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT">
|
|
<p class="Normal">The following section supplements the instructions found in the <a href="https://grants.nih.gov/grants/guide/url_redirect.php?id=82400">How to Apply – Application Guide</a> and should be used for preparing an application to this NOFO.</p>
|
|
</div>
|
|
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|
|
<div data-element-id="191602" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT">
|
|
<p class="heading4">SF424(R&R) Cover</p>
|
|
|
|
<p class="Normal">All instructions in the <a href="https://grants.nih.gov/grants/guide/url_redirect.php?id=82400">How to Apply - Application Guide</a> must be followed.</p>
|
|
</div>
|
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|
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|
<div data-element-id="191604" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT">
|
|
<p class="heading4">SF424(R&R) Project/Performance Site Locations</p>
|
|
|
|
<p class="Normal">All instructions in the <a href="https://grants.nih.gov/grants/guide/url_redirect.php?id=82400">How to Apply - Application Guide</a> must be followed.</p>
|
|
</div>
|
|
|
|
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|
|
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|
|
<div data-element-id="191606" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT">
|
|
<p class="heading4">SF424(R&R) Other Project Information</p>
|
|
|
|
<p class="Normal">All instructions in the <a href="https://grants.nih.gov/grants/guide/url_redirect.php?id=82400">How to Apply - Application Guide</a> must be followed.</p>
|
|
</div>
|
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|
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|
|
<div data-element-id="191607" data-element-has-label="false" data-element-required="false" data-element-has-value="false" data-section-code="ASI" data-element-type="TEXT">
|
|
|
|
</div>
|
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|
|
<div data-element-id="191608" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT">
|
|
<p class="heading4">SF424(R&R) Senior/Key Person Profile</p>
|
|
|
|
<p class="Normal">All instructions in the <a href="https://grants.nih.gov/grants/guide/url_redirect.php?id=82400">How to Apply - Application Guide</a> must be followed.</p>
|
|
</div>
|
|
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|
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|
|
<div data-element-id="191610" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT">
|
|
<p class="heading4">R&R or Modular Budget</p>
|
|
|
|
<p class="Normal">All instructions in the <a href="https://grants.nih.gov/grants/guide/url_redirect.php?id=82400">How to Apply - Application Guide</a> must be followed.</p>
|
|
</div>
|
|
|
|
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|
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|
|
|
|
<div data-element-id="191612" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT">
|
|
<p class="heading4">R&R Subaward Budget</p>
|
|
|
|
<p class="Normal">All instructions in the <a href="https://grants.nih.gov/grants/guide/url_redirect.php?id=82400">How to Apply - Application Guide</a> must be followed.</p>
|
|
</div>
|
|
|
|
|
|
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|
|
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|
|
<div data-element-id="191614" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT">
|
|
<p class="heading4">PHS 398 Cover Page Supplement</p>
|
|
|
|
<p class="Normal">All instructions in the <a href="https://grants.nih.gov/grants/guide/url_redirect.php?id=82400">How to Apply - Application Guide</a> must be followed.</p>
|
|
</div>
|
|
|
|
|
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|
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|
|
<div data-element-id="191616" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT">
|
|
<p class="heading4">PHS 398 Research Plan</p>
|
|
|
|
<p class="Normal">All instructions in the <a href="https://grants.nih.gov/grants/guide/url_redirect.php?id=82400">How to Apply - Application Guide</a> must be followed, with the following additional instructions:</p>
|
|
</div>
|
|
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|
|
<div data-element-id="191617" data-element-has-label="false" data-element-required="false" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT">
|
|
<p><strong>Research Strategy: </strong>Describe the focus of the proposed secondary analyses, resources to be used, and potential scientific contributions to the field of HIV/AIDS in maternal, pediatric, and adolescent populations. Provide feasibility data to support your application, especially if the use of stored samples could impact certain assays or methodologies.</p><p><strong>Letters of Support</strong>: Letters of support and/or commitment must be provided from collaborators, key personnel, institutions, or other significant contributors for any data sets, resources, biospecimen collections, or partnerships required for the proposed project.</p>
|
|
</div>
|
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|
|
<div data-element-id="191618" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT">
|
|
<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 <a href="https://grants.nih.gov/grants/guide/url_redirect.php?id=82400">How to Apply - Application Guide</a>.</p>
|
|
</div>
|
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|
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|
|
<div data-element-id="191619" data-element-has-label="false" data-element-required="false" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT">
|
|
<p>The following modifications also apply:</p><p>NICHD expects that biospecimens resulting from NICHD-funded research will be shared with the wider scientific community to the extent feasible and in a timely manner.</p><p>Researchers can submit information about the location and availability of biospecimens to the DASH catalog, if applicable.</p>
|
|
</div>
|
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|
|
<div data-element-id="191620" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT">
|
|
<p class="Normal"><strong>Other Plan(s): </strong>Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.</p>
|
|
|
|
<p class="Normal">All instructions in the <a href="https://grants.nih.gov/grants/guide/url_redirect.php?id=82400">How to Apply - Application Guide</a> must be followed, with the following additional instructions:</p>
|
|
</div>
|
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|
|
<div data-element-id="191621" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT">
|
|
<ul><li>All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.</li><li>For more information, see Section I, NICHD Data Sharing Expectations.</li></ul>
|
|
</div>
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<div data-element-id="191622" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT">
|
|
<p class="Normal"><strong>Appendix:</strong> Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the <a href="https://grants.nih.gov/grants/guide/url_redirect.php?id=82400">How to Apply - Application Guide</a>.</p>
|
|
|
|
<ul>
|
|
<li class="Normal">No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.</li>
|
|
</ul>
|
|
</div>
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<div data-element-id="191623" data-element-has-label="false" data-element-required="false" data-element-has-value="false" data-section-code="ASI" data-element-type="TEXT">
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</div>
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<div data-element-id="191624" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT">
|
|
<p class="heading4">PHS Human Subjects and Clinical Trials Information</p>
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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 <a href="https://grants.nih.gov/grants/guide/url_redirect.php?id=82400">How to Apply - Application Guide</a>, 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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|
<p class="Normal">All instructions in the <a href="https://grants.nih.gov/grants/guide/url_redirect.php?id=82400">How to Apply - Application Guide</a> must be followed.</p>
|
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</div>
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<div data-element-id="191625" data-element-has-label="false" data-element-required="false" data-element-has-value="false" data-section-code="ASI" data-element-type="TEXT">
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</div>
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<div data-element-id="191626" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT">
|
|
<p class="Normal"><strong>Delayed Onset Study</strong></p>
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|
<p class="Normal">Note: <a href="https://grants.nih.gov/grants/glossary.htm#DelayedOnsetStudy">Delayed onset</a> does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the <a href="https://grants.nih.gov/grants/guide/url_redirect.php?id=82400">How to Apply - Application Guide</a> must be followed.</p>
|
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</div>
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<div data-element-id="191627" data-element-has-label="false" data-element-required="false" data-element-has-value="false" data-section-code="ASI" data-element-type="TEXT">
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</div>
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<div data-element-id="191628" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT">
|
|
<p class="heading4">PHS Assignment Request Form</p>
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|
<p class="Normal">All instructions in the <a href="https://grants.nih.gov/grants/guide/url_redirect.php?id=82400">How to Apply - Application Guide</a> must be followed.</p>
|
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</div>
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<div data-element-id="191630" data-element-has-label="false" data-element-required="false" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT">
|
|
<p class="heading4">Foreign Organizations</p>
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|
<p class="Normal">Foreign (non-U.S.) organizations must follow policies described in the <a href="//grants.nih.gov/grants/guide/url_redirect.php?id=11137">NIH Grants Policy Statement</a>, and procedures for foreign organizations described throughout the How to Apply Application Guide.</p>
|
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</div>
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<div data-element-id="191631" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT">
|
|
<p class="heading4">3. Unique Entity Identifier and System for Award Management (SAM)</p>
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|
|
<p class="Normal">See Part 2. 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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<div data-element-id="191632" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT">
|
|
<p class="heading4">4. Submission Dates and Times</p>
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|
<p class="Normal"><a href="#_Part_1._Overview">Part I.</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 <a href="https://grants.nih.gov/grants/guide/url_redirect.php?id=82380">Federal holiday</a>, the application deadline is automatically extended to the next business day.</p>
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|
<p class="Normal">Organizations must submit applications to <a href="//grants.nih.gov/grants/guide/url_redirect.php?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.php?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 <a href="//grants.nih.gov/grants/guide/url_redirect.php?id=82423">NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications</a>.</p>
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|
<p class="Normal"><strong>Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.</strong></p>
|
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|
<p class="Normal">Information on the submission process and a definition of on-time submission are provided in the <a href="https://grants.nih.gov/grants/guide/url_redirect.php?id=82400">How to Apply – Application Guide</a>.</p>
|
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</div>
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<div data-element-id="191633" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT">
|
|
<p class="heading4">5. Intergovernmental Review (E.O. 12372)</p>
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|
|
<p class="Normal">This initiative is not subject to <a href="https://grants.nih.gov/grants/policy/nihgps/html5/section_10/10.10.1_executive_orders.htm">intergovernmental review.</a></p>
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</div>
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<div data-element-id="191634" data-element-has-label="false" data-element-required="false" data-element-has-value="false" data-section-code="ASI" data-element-type="TEXT">
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</div>
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<div data-element-id="191635" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT">
|
|
<p class="heading4">6. Funding Restrictions</p>
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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.php?id=11120">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.php?id=11143">NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost</a>.</p>
|
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</div>
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<div data-element-id="191636" data-element-has-label="false" data-element-required="false" data-element-has-value="false" data-section-code="ASI" data-element-type="TEXT">
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</div>
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<div data-element-id="191637" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT">
|
|
<p class="heading4">7. Other Submission Requirements and Information</p>
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|
<p class="Normal">Applications must be submitted electronically following the instructions described in the <a href="https://grants.nih.gov/grants/guide/url_redirect.php?id=82400">How to Apply - Application Guide</a>. Paper applications will not be accepted.</p>
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|
|
<p class="Normal">Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.</p>
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|
<p class="Normal">For assistance with your electronic application or for more information on the electronic submission process, visit <a href="https://grants.nih.gov/grants/guide/url_redirect.php?id=82400">How to Apply – Application Guide</a>. 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">Dealing with System Issues</a> guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.</p>
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<p class="Normal"><strong>Important reminders:</strong></p>
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|
<p class="Normal">All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form<b>. </b>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 Section III of this NOFO for information on registration requirements.</p>
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|
|
<p class="Normal">The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the <a href="https://grants.nih.gov/grants/guide/url_redirect.php?id=82400">How to Apply - Application Guide</a>.</p>
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|
|
<p class="Normal">See <a href="//grants.nih.gov/grants/guide/url_redirect.php?id=11146">more tips</a> for avoiding common errors.</p>
|
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</div>
|
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<div data-element-id="191638" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT">
|
|
<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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</div>
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<div data-element-id="191639" data-element-has-label="false" data-element-required="false" data-element-has-value="false" data-section-code="ASI" data-element-type="TEXT">
|
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</div>
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<div data-element-id="191640" data-element-has-label="false" data-element-required="false" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT">
|
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<p class="heading4"> </p>
|
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</div>
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<div data-element-id="191641" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT">
|
|
<p class="heading4">Post Submission Materials</p>
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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.php?id=82299">the policy</a></p>
|
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</div>
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<div data-element-id="191642" data-element-has-label="false" data-element-required="false" data-element-has-value="false" data-section-code="ASI" data-element-type="TEXT">
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</div>
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<div data-element-id="191643" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ARI" data-element-type="TEXT">
|
|
<a name="_Section V. Application Review Information"></a><h2 class="heading2">Section V. Application Review Information</h2>
|
|
</div>
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<div data-element-id="191644" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ARI" data-element-type="TEXT">
|
|
<p class="heading4">1. Criteria</p>
|
|
|
|
<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.php?id=11149">NIH mission</a> are evaluated for scientific and technical merit through the NIH peer review system.</p>
|
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</div>
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<div data-element-id="191645" data-element-has-label="false" data-element-required="false" data-element-has-value="true" data-section-code="ARI" data-element-type="TEXT">
|
|
<p class="Normal">For this particular NOFO, note the following:<br>
|
|
</p>
|
|
|
|
<p class="Normal" style="margin-left: 25px;">The R21 exploratory/developmental grant supports investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research. An R21 grant application need not have extensive background material or preliminary information. Accordingly, reviewers will emphasize the conceptual framework, the level of innovation, 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. Preliminary data are not required for R21 applications; however, they may be included if available.</p>
|
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</div>
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<div data-element-id="191646" data-element-has-label="false" data-element-required="false" data-element-has-value="false" data-section-code="ARI" data-element-type="TEXT">
|
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|
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</div>
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<div class="heading4" tabindex="0" data-element-id="191648" data-element-required="true" data-element-has-value="true" data-section-code="ARI" data-element-type="TEXT">
|
|
Overall Impact
|
|
</div>
|
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|
|
<div data-element-id="191648" data-element-has-label="true" data-element-required="true" data-element-has-value="true" data-section-code="ARI" data-element-type="TEXT">
|
|
<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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</div>
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<div class="heading4" tabindex="0" data-element-id="191649" data-element-required="true" data-element-has-value="true" data-section-code="ARI" data-element-type="TEXT">
|
|
Scored Review Criteria
|
|
</div>
|
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|
|
<div data-element-id="191649" data-element-has-label="true" data-element-required="true" data-element-has-value="true" data-section-code="ARI" data-element-type="TEXT">
|
|
<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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</div>
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<div data-element-id="191650" data-element-has-label="false" data-element-required="false" data-element-has-value="true" data-section-code="ARI" data-element-type="LINKED_ELEMENT">
|
|
<div class="P_SingleIndent criteria-div"> <label class="heading4">Significance</label> <br/>
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|
<span><p>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?</p></span>
|
|
<span></span>
|
|
<label class="heading4">Investigator(s)</label> <br/>
|
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|
|
<span><p class="Normal">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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</span>
|
|
<span></span>
|
|
<label class="heading4">Innovation</label> <br/>
|
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|
|
<span><p class="Normal">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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</span>
|
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<span></span>
|
|
<label class="heading4">Approach</label> <br/>
|
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|
<span><p class="Normal">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? 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">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), justified in terms of the scientific goals and research strategy proposed?</p>
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</span>
|
|
<span></span>
|
|
<label class="heading4">Environment</label> <br/>
|
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|
<span><p class="Normal">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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</span>
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<span></span>
|
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</div>
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</div>
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<div class="heading4" tabindex="0" data-element-id="191651" data-element-required="true" data-element-has-value="true" data-section-code="ARI" data-element-type="TEXT">
|
|
Additional Review Criteria
|
|
</div>
|
|
|
|
<div data-element-id="191651" data-element-has-label="true" data-element-required="true" data-element-has-value="true" data-section-code="ARI" data-element-type="TEXT">
|
|
<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>
|
|
</div>
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<div data-element-id="191652" data-element-has-label="false" data-element-required="false" data-element-has-value="true" data-section-code="ARI" data-element-type="LINKED_ELEMENT">
|
|
<div class="P_SingleIndent criteria-div"> <label class="heading4">Protections for Human Subjects</label> <br/>
|
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|
|
<span><p>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><p>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.php?id=11175">Guidelines for the Review of Human Subjects</a>.</p></span>
|
|
<span></span>
|
|
<label class="heading4">Inclusion of Women, Minorities, and Individuals Across the Lifespan</label> <br/>
|
|
|
|
<span><p>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) 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.php?id=11174">Guidelines for the Review of Inclusion in Clinical Research</a>.</p></span>
|
|
<span></span>
|
|
<label class="heading4">Vertebrate Animals</label> <br/>
|
|
|
|
<span><p>The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the <a href="//grants.nih.gov/grants/guide/url_redirect.php?id=11150">Worksheet for Review of the Vertebrate Animals Section.</a></p></span>
|
|
<span></span>
|
|
<label class="heading4">Biohazards</label> <br/>
|
|
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<span><p>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></span>
|
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<span></span>
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|
<label class="heading4">Resubmissions</label> <br/>
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|
<span></span>
|
|
<span><p>Not Applicable</p></span>
|
|
<label class="heading4">Renewals</label> <br/>
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|
<span></span>
|
|
<span><p>Not applicable</p></span>
|
|
<label class="heading4">Revisions</label> <br/>
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<span></span>
|
|
<span><p>Not applicable</p></span>
|
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</div>
|
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</div>
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<div class="heading4" tabindex="0" data-element-id="191653" data-element-required="true" data-element-has-value="true" data-section-code="ARI" data-element-type="TEXT">
|
|
Additional Review Considerations
|
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</div>
|
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<div data-element-id="191653" data-element-has-label="true" data-element-required="true" data-element-has-value="true" data-section-code="ARI" data-element-type="TEXT">
|
|
<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>
|
|
</div>
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<div data-element-id="191654" data-element-has-label="false" data-element-required="false" data-element-has-value="true" data-section-code="ARI" data-element-type="LINKED_ELEMENT">
|
|
<div class="P_SingleIndent criteria-div"> <label class="heading4">Applications from Foreign Organizations</label> <br/>
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<span><p class="Normal">Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.</p>
|
|
</span>
|
|
<span></span>
|
|
<label class="heading4">Select Agent Research</label> <br/>
|
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|
<span><p class="Normal">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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</span>
|
|
<span></span>
|
|
<label class="heading4">Resource Sharing Plans</label> <br/>
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|
<span><p class="Normal">Reviewers will comment on whether the Resource Sharing Plan(s) (e.g., <a href="https://sharing.nih.gov/other-sharing-policies/model-organism-sharing-policy#policy-overview">Sharing Model Organisms</a>) or the rationale for not sharing the resources, is reasonable.</p>
|
|
</span>
|
|
<span></span>
|
|
<label class="heading4">Authentication of Key Biological and/or Chemical Resources</label> <br/>
|
|
|
|
<span><p class="Normal">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>
|
|
</span>
|
|
<span></span>
|
|
<label class="heading4">Budget and Period of Support</label> <br/>
|
|
|
|
<span><p class="Normal">Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.</p>
|
|
</span>
|
|
<span></span>
|
|
</div>
|
|
</div>
|
|
|
|
|
|
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|
|
|
|
|
|
<div data-element-id="191655" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ARI" data-element-type="TEXT">
|
|
<p class="heading4">2. Review and Selection Process</p>
|
|
</div>
|
|
|
|
|
|
|
|
|
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|
|
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|
|
<div data-element-id="191656" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ARI" data-element-type="TEXT">
|
|
<p>Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NICHD, in accordance with <a href="//grants.nih.gov/grants/guide/url_redirect.php?id=11154">NIH peer review policy and procedures</a>, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.</p>
|
|
</div>
|
|
|
|
|
|
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|
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|
|
|
|
|
|
<div data-element-id="191657" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ARI" data-element-type="TEXT">
|
|
<p class="Normal">As part of the scientific peer review, all applications will receive a written critique.</p>
|
|
</div>
|
|
|
|
|
|
|
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|
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|
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|
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|
|
<div data-element-id="191658" data-element-has-label="false" data-element-required="false" data-element-has-value="true" data-section-code="ARI" data-element-type="TEXT">
|
|
<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>
|
|
</div>
|
|
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|
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|
|
<div data-element-id="191659" data-element-has-label="false" data-element-required="false" data-element-has-value="true" data-section-code="ARI" data-element-type="CHECKBOX">
|
|
<p class="Normal"><a href="https://grants.nih.gov/grants/policy/nihgps/html5/section_2/2.4.2_appeals_of_initial_scientific_review.htm">Appeals</a> of initial peer review will not be accepted for applications submitted in response to this NOFO.</p>
|
|
</div>
|
|
|
|
|
|
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|
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|
|
|
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|
|
<div data-element-id="191660" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ARI" data-element-type="TEXT">
|
|
<p>Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Child Health and Human Development Council (NACHHD). The following will be considered in making funding decisions:</p><ul><li>Scientific and technical merit of the proposed project as determined by scientific peer review.</li><li>Availability of funds.</li><li>Relevance of the proposed project to program priorities.</li></ul>
|
|
</div>
|
|
|
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|
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|
|
|
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|
|
<div data-element-id="191661" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ARI" data-element-type="TEXT">
|
|
<p class="heading4">3. Anticipated Announcement and Award Dates</p>
|
|
|
|
<p class="Normal">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.php?id=11123">eRA Commons</a>. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.</p>
|
|
|
|
<p class="Normal">Information regarding the disposition of applications is available in the <a href="//grants.nih.gov/grants/guide/url_redirect.php?id=82416">NIH Grants Policy Statement Section 2.4.4 Disposition of Applications</a>.</p>
|
|
</div>
|
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|
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|
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|
|
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|
|
|
|
|
<div data-element-id="191662" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="AAI" data-element-type="TEXT">
|
|
<a name="_Section VI. Award Administration Information"></a><h2 class="heading2">Section VI. Award Administration Information</h2>
|
|
</div>
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
<div data-element-id="191663" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="AAI" data-element-type="TEXT">
|
|
<p class="heading4">1. Award Notices</p>
|
|
|
|
<p class="Normal">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.php?id=82418">NIH Grants Policy Statement</a>. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding. </p>
|
|
|
|
<p class="Normal">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 recipient's business official.</p>
|
|
|
|
<p class="Normal">Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. 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>
|
|
|
|
<p class="Normal">Any application awarded in response to this NOFO will be subject to terms and conditions found on the <a href="https://grants.nih.gov/grants/policy/nihgps/HTML5/part_ii_subpart_b.htm">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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</div>
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|
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<div data-element-id="191664" data-element-has-label="false" data-element-required="false" data-element-has-value="true" data-section-code="AAI" data-element-type="TEXT">
|
|
<p class="Normal">Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.</p>
|
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</div>
|
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|
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<div data-element-id="191665" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="AAI" data-element-type="TEXT">
|
|
<h4>2. Administrative and National Policy Requirements</h4><p>All NIH grant and cooperative agreement awards include the <a href="//grants.nih.gov/grants/guide/url_redirect.php?id=11120">NIH Grants Policy Statement</a> as part of the NoA. For these terms of award, see the <a href="//grants.nih.gov/grants/guide/url_redirect.php?id=11157">NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General</a> and <a href="//grants.nih.gov/grants/guide/url_redirect.php?id=11159">Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities</a>, including of note, but not limited to:</p><ul><li><a href="https://grants.nih.gov/grants/policy/nihgps/HTML5/section_3/3.1_federalwide_standard_terms_and_conditions_for_research_grants.htm">Federalwide Standard Terms and Conditions for Research Grants</a></li><li><a href="//grants.nih.gov/grants/guide/url_redirect.php?id=82417">Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment</a></li><li><a href="https://grants.nih.gov/grants/policy/nihgps/HTML5/section_4/4.2.1_acknowledgement_of_federal_funding.htm">Acknowledgment of Federal Funding</a></li></ul><p>If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.</p><p>If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (<a href="https://www.hhs.gov/sites/default/files/form-hhs690.pdf">HHS-690</a>). To learn more, see the <a href="https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/laws/index.html">Laws and Regulations Enforced by the HHS Office for Civil Rights website</a>.</p><p>HHS recognizes that NIH 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 NOFO.</p><p>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 System for Award Management (SAM.gov) requirements. SAM.gov requires Federal agencies to review and consider information about an applicant in the designated integrity and performance system (currently SAM.gov) prior to making an award. An applicant can review and comment on any information in the responsibility/qualification records available in SAM.gov. NIH will consider any comments by the applicant, in addition to the information available in the responsibility/qualification records in SAM.gov, 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 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.</p>
|
|
</div>
|
|
|
|
|
|
|
|
|
|
|
|
|
|
<div class="heading4" tabindex="0" data-element-id="191666" data-element-required="true" data-element-has-value="true" data-section-code="AAI" data-element-type="TEXT">
|
|
Cooperative Agreement Terms and Conditions of Award
|
|
</div>
|
|
|
|
<div data-element-id="191666" data-element-has-label="true" data-element-required="true" data-element-has-value="true" data-section-code="AAI" data-element-type="TEXT">
|
|
<p class="Normal">Not Applicable</p>
|
|
</div>
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
<div data-element-id="191667" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="AAI" data-element-type="TEXT">
|
|
<p class="heading4">3. Data Management and Sharing</p>
|
|
|
|
<p class="Normal">Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the <a href="https://grants.nih.gov/grants/policy/nihgps/HTML5/section_8/8.2.3_sharing_research_resources.htm#Data">NIH Grants Policy Statement</a>. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.</p>
|
|
</div>
|
|
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|
|
|
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|
|
|
|
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|
|
<div data-element-id="191668" data-element-has-label="false" data-element-required="false" data-element-has-value="false" data-section-code="AAI" data-element-type="TEXT">
|
|
|
|
</div>
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
<div data-element-id="191669" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="AAI" data-element-type="TEXT">
|
|
<p class="heading4">4. Reporting</p>
|
|
|
|
<p class="Normal">When multiple years are involved, recipients 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.php?id=82419">NIH Grants Policy Statement</a>.</p>
|
|
</div>
|
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|
|
<div data-element-id="191670" data-element-has-label="false" data-element-required="false" data-element-has-value="false" data-section-code="AAI" data-element-type="TEXT">
|
|
|
|
</div>
|
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|
|
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|
|
<div data-element-id="191671" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="AAI" data-element-type="TEXT">
|
|
<p class="Normal">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.php?id=82420">NIH Grants Policy Statement</a>. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.</p>
|
|
|
|
<p class="Normal">The Federal Funding Accountability and Transparency Act of 2006 as amended (FFATA), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients 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.php?id=11170">www.fsrs.gov</a> on all subawards over the threshold. See the <a href="//grants.nih.gov/grants/guide/url_redirect.php?id=82420">NIH Grants Policy Statement</a> for additional information on this reporting requirement.</p>
|
|
|
|
<p class="Normal">In accordance with the regulatory requirements provided at 2 CFR Part 200.113 and Appendix XII to 2 CFR Part 200, 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 (Responsibility/Qualification in SAM.gov, formerly 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 2 CFR Part 200 – Award Term and Condition for Recipient Integrity and Performance Matters.</p>
|
|
</div>
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|
|
<div data-element-id="191673" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="AC" data-element-type="TEXT">
|
|
<a name="_Section VII. Agency Contacts"></a><h2 class="heading2">Section VII. Agency Contacts</h2>
|
|
</div>
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|
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<div data-element-id="191674" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="AC" data-element-type="TEXT">
|
|
<p>We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.</p>
|
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</div>
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<div class="heading4" tabindex="0" data-element-id="191675" data-element-required="true" data-element-has-value="true" data-section-code="AC" data-element-type="TEXT">
|
|
Application Submission Contacts
|
|
</div>
|
|
|
|
<div data-element-id="191675" data-element-has-label="true" data-element-required="true" data-element-has-value="true" data-section-code="AC" data-element-type="TEXT">
|
|
<p class="Normal">eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)</p>
|
|
|
|
<p class="Normal">Finding Help Online: <a href="https://www.era.nih.gov/need-help" target="_blank" title="https://www.era.nih.gov/need-help">https://www.era.nih.gov/need-help</a> (preferred method of contact)<br>
|
|
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)</p>
|
|
|
|
<p class="Normal">General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)<br>
|
|
Email: <a href="/cdn-cgi/l/email-protection#713603101f0502381f171e311f18195f161e07"><span class="__cf_email__" data-cfemail="793e0b18170d0a30171f1639171011571e160f">[email protected]</span></a> (preferred method of contact)<br>
|
|
Telephone: 301-637-3015</p>
|
|
|
|
<p class="Normal">Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)<br>
|
|
Contact Center Telephone: 800-518-4726<br>
|
|
Email: <a href="/cdn-cgi/l/email-protection#52212722223d2026123520333c26217c353d24"><span class="__cf_email__" data-cfemail="ea999f9a9a85989eaa8d988b849e99c48d859c">[email protected]</span></a></p>
|
|
</div>
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|
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<div class="heading4" tabindex="0" data-element-id="191676" data-element-required="true" data-element-has-value="true" data-section-code="AC" data-element-type="TEXT">
|
|
Scientific/Research Contact(s)
|
|
</div>
|
|
|
|
<div data-element-id="191676" data-element-has-label="true" data-element-required="true" data-element-has-value="true" data-section-code="AC" data-element-type="TEXT">
|
|
<p>Eric Lorenzo, PhD<br><i>Eunice Kennedy Shriver</i> National Institute of Child Health and Human Development (NICHD)<br>Telephone: 301-443-4993<br>Email: <a href="/cdn-cgi/l/email-protection#c3a6b1aaa0edafacb1a6adb9ac83adaaabeda4acb5"><span class="__cf_email__" data-cfemail="5d382f343e7331322f383327321d333435733a322b">[email protected]</span></a></p>
|
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</div>
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<div data-element-id="191677" data-element-has-label="false" data-element-required="false" data-element-has-value="true" data-section-code="AC" data-element-type="LINKED_ELEMENT">
|
|
<p>Anais Stenson, Ph.D.<br>National Institute of Mental Health (NIMH)<br>Telephone: 240-926-7572<br>Email: <a href="/cdn-cgi/l/email-protection#90f1fef1f9e3bee3e4f5fee3fffed0fef9f8bef7ffe6"><span class="__cf_email__" data-cfemail="fa9b949b9389d4898e9f94899594ba949392d49d958c">[email protected]</span></a></p>
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</div>
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<p>Joanna Kubler-Kielb, PhD<br><i>Eunice Kennedy Shriver</i> National Institute of Child Health & Human Development (NICHD)<br>Telephone: 301-435-6916<br>Email: <a href="/cdn-cgi/l/email-protection#6a01030f0608002a070b030644040302440d051c"><span class="__cf_email__" data-cfemail="2e45474b424c446e434f47420040474600494158">[email protected]</span></a></p>
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<p class="Normal">Margaret Young<br><i>Eunice Kennedy Shriver </i>National Institute of Child Health and Human Development (NICHD)<br>Telephone: 301-642-4552<br>Email:<a href="/cdn-cgi/l/email-protection#7d101c0f1a1c0f180953041208131a3d131415531a120b"><span class="__cf_email__" data-cfemail="335e524154524156471d4a5c465d54735d5a5b1d545c45">[email protected]</span></a></p>
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<p>Rita Sisco<br>National Institute of Mental Health (NIMH)<br>Telephone: 301-443-2805<br>Email: <a href="/cdn-cgi/l/email-protection#15667c66767a675578747c793b7b7c7d3b727a63"><span class="__cf_email__" data-cfemail="07746e74646875476a666e6b29696e6f29606871">[email protected]</span></a></p>
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<a name="_Section VIII. Other Information"></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.php?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.php?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.php?id=11120">NIH Grants Policy Statement</a>.</p>
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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 2 CFR Part 200.</p>
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<A HREF="/grants/guide/WeeklyIndex.cfm?04-26-24">Weekly TOC for this Announcement</A><br>
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