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<!-- From FOATemplate.txt -->
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<TITLE>Expired RFA-AI-20-078: Immune Development in Early Life (IDEaL) (U19 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: Immune Development in Early Life (IDEaL) (U19 Clinical Trial Not Allowed) RFA-AI-20-078. NIAID">
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<META NAME="Keywords" CONTENT="RFA-AI-20-078: Immune Development in Early Life (IDEaL) (U19 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>
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<div class="row">
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<div class="col-xs-12">
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<div class=WordSection1>
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<div class="heading1"><a name="_Toc258852634"></a>Department of Health and Human Services</div>
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<div class="heading1"><a name="_Toc258873264"></a><a
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name="_Part_1._Overview"></a>Part 1. Overview Information</div>
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<table class=regulartextTable border=1 cellspacing=0 cellpadding=0 width="100%">
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<div class="row">
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<div class="col-md-4 datalabel">Participating Organization(s)</div>
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<div class="col-md-8 datacolumn"><p class=regulartext>National Institutes of Health (<a href="http://www.nih.gov">NIH</a>)</p></div>
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</div><!--end row-->
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<div class="row">
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<div class="col-md-4 datalabel"><a name="_Components_of_Participating"></a>Components
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of Participating Organizations</div>
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<div class="col-md-8 datacolumn"><p class=regulartext>National Institute of Allergy and Infectious Diseases (<a
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href="http://www.niaid.nih.gov">NIAID</a>)<br>
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National Institute of Environmental Health Sciences (<a
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href="http://www.niehs.nih.gov">NIEHS</a><br>
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<em>Eunice Kennedy Shriver</em> National Institute of Child Health and Human Development (<a href="https://www.nichd.nih.gov/">NICHD</a>)</p></div>
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</div><!--end row-->
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<div class="row">
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<div class="col-md-4 datalabel">Funding Opportunity Title</div>
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<div class="col-md-8 datacolumn"><p class="title">Immune Development in Early Life (IDEaL) (U19
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Clinical Trial Not Allowed)</p></div>
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</div><!--end row-->
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<div class="row">
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<div class="col-md-4 datalabel">Activity Code</div>
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<div class="col-md-8 datacolumn"><p class=regulartext><a
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href="//grants.nih.gov/grants/funding/ac_search_results.htm?text_curr=u19&Search.x=0&Search.y=0&sort=ac&Search_Type=Activity&text_prev=">U19</a>
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Research Project Cooperative Agreements</p></div>
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</div><!--end row-->
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<div class="row">
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<div class="col-md-4 datalabel">Announcement Type</div>
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<div class="col-md-8 datacolumn"><p class=regulartext>New</p></div>
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</div><!--end row-->
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<div class="row">
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<div class="col-md-4 datalabel">Related Notices</div>
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<div class="col-md-8 datacolumn">
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<ul>
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<li><strong>May 3, 2021</strong> - Notice of NICHD Participation in RFA-AI-20-078. See Notice <a href="//grants.nih.gov/grants/guide/notice-files/NOT-HD-21-030.html">NOT-HD-21-030</a>.</li>
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<li><strong>April 28, 2021</strong> - Notice of Change in Key Dates for RFA-AI-20-078. See Notice <a href="//grants.nih.gov/grants/guide/notice-files/NOT-AI-21-049.html">NOT-AI-21-049</a>.</li>
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</ul>
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</div>
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</div><!--end row-->
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<div class="row">
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<div class="col-md-4 datalabel">Funding Opportunity Announcement (FOA) Number</div>
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<div class="col-md-8 datacolumn"><p class="title">RFA-AI-20-078 </p></div>
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</div><!--end row-->
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<div class="row">
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<div class="col-md-4 datalabel">Companion Funding Opportunity</div>
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<div class="col-md-8 datacolumn"><p class=regulartext><a
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href="https://grants.nih.gov/grants/guide/rfa-files/RFA-AI-20-077.html">RFA-AI-20-077</a>
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- <a
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href="//grants.nih.gov/grants/funding/ac_search_results.htm?text_curr=u01&Search.x=0&Search.y=0&Search_Type=Activity">U01</a>
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Research Project Cooperative Agreements </p></div>
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</div><!--end row-->
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<div class="row">
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<div class="col-md-4 datalabel"><a name="_Number_of_Applications"></a>Number of
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Applications</div>
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<div class="col-md-8 datacolumn"><p class=regulartext>See <a href="#_3._Additional_Information">Section III. 3.
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Additional Information on Eligibility</a>. </p></div>
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</div><!--end row-->
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<div class="row">
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<div class="col-md-4 datalabel">Catalog of Federal Domestic Assistance (CFDA) Number(s)<sub>
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</sub></div>
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<div class="col-md-8 datacolumn"><p class=regulartext>93.855; 93.113, 93.865 </p></div>
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</div><!--end row-->
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<div class="row">
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<div class="col-md-4 datalabel">Funding Opportunity Purpose</div>
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<div class="col-md-8 datacolumn"><p class=regulartext>The purpose of this Funding Opportunity Announcement is to
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support research to define the mechanisms regulating the establishment,
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development, and maintenance of immunity throughout childhood (from birth to
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less than 18 years of age), including the impact of pathogenic or commensal
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microbes or vaccination against infectious diseases, allergens, and
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environmental pollutants on immune ontogeny and function. This program will
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establish collaborations among immunologists, neonatologists, pediatricians,
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systems biologists, and microbiologists to expand our knowledge of the
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developing immune system. Knowledge obtained through this program may be
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applied to the design of improved vaccines and immunotherapies to combat
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infections or treat/prevent immune-mediated diseases in this vulnerable
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population. </p></div>
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</div><!--end row-->
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</table>
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<div class="heading2" style="clear:both;">Key Dates</div>
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<table class=regulartextTable border=1 cellspacing=0 cellpadding=0 width="100%">
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<div class="row">
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<div class="col-md-4 datalabel">Posted Date</div>
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<div class="col-md-8 datacolumn"><p class=regulartext>January 12, 2021</p></div>
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</div><!--end row-->
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<div class="row">
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<div class="col-md-4 datalabel">Open Date (Earliest Submission Date)</div>
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<div class="col-md-8 datacolumn"><p class=regulartext><strong>New Date</strong> May 18, 2021</p></div>
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</div><!--end row-->
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<div class="row">
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<div class="col-md-4 datalabel">Letter of Intent Due Date(s)</div>
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<div class="col-md-8 datacolumn"><p class=regulartext>30 days prior to the application due date </p></div>
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</div><!--end row-->
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<div class="row">
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<div class="col-md-4 datalabel">Application Due Date(s)</div>
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<div class="col-md-8 datacolumn"><p class=regulartext><strong>New Date</strong> June 18, 2021</p>
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<p class=regulartext>All applications are due by 5:00 PM local time of
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applicant organization. All <a href="#Application Types Allowed">types of non-AIDS
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applications</a> allowed for this funding opportunity announcement are due on
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the listed date.</p>
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<p class=regulartext>Applicants are encouraged to apply early to allow adequate
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time to make any corrections to errors found in the application during the
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submission process by the due date.</p></div>
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</div><!--end row-->
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<div class="row">
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<div class="col-md-4 datalabel">AIDS Application Due Date(s)</div>
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<div class="col-md-8 datacolumn"><p class=regulartext><strong>New Date</strong> June 18, 2021</p>
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<p class=regulartext>All applications are due by 5:00 PM local time of
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applicant organization. </p>
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<p class=regulartext>All <a href="#Application Types Allowed">types of AIDS and
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AIDS-related applications</a> allowed for this funding opportunity
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announcement are due on the listed date. </p>
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<p class=regulartext>Applicants are encouraged to apply early to allow adequate
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time to make any corrections to errors found in the application during the
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submission process by the due date.</p></div>
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</div><!--end row-->
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<div class="row">
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<div class="col-md-4 datalabel">Scientific Merit Review </div>
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<div class="col-md-8 datacolumn"><p class=regulartext><a
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href="http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward"></a>October
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2021 </p></div>
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</div><!--end row-->
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<div class="row">
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<div class="col-md-4 datalabel">Advisory Council Review</div>
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<div class="col-md-8 datacolumn"><p class=regulartext>January 2022 </p></div>
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</div><!--end row-->
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<div class="row">
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<div class="col-md-4 datalabel">Earliest Start Date</div>
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<div class="col-md-8 datacolumn"><p class=regulartext>March 2022 </p></div>
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</div><!--end row-->
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<div class="row">
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<div class="col-md-4 datalabel">Expiration Date</div>
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<div class="col-md-8 datacolumn"><p><strong>New Date</strong> June 19, 2021 per issuance of <a href="//grants.nih.gov/grants/guide/notice-files/NOT-AI-21-049.html">NOT-AI-21-049</a>. (Original Expiration Date: June 05, 2021)</p></div>
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</div><!--end row-->
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<div class="row">
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<div class="col-md-4 datalabel">Due Dates for E.O. 12372 </div>
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<div class="col-md-8 datacolumn"><p class=regulartext>Not Applicable</p></div>
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</div><!--end row-->
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</table>
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<div class="heading4"><a name="_Required_Application_Instructions"></a>Required
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Application Instructions</div>
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<p class=regulartext>It is critical that applicants follow the Multi-Project (M)
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Instructions in the <a
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href="//grants.nih.gov/grants/guide/url_redirect.htm?id=12000">SF424
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(R&R) Application Guide</a>, except where instructed to do otherwise (in
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this FOA or in a Notice from the <a href="//grants.nih.gov/grants/guide/"><i>NIH
|
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Guide for Grants and Contracts</i></a>). Conformance to all requirements (both
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in the Application Guide and the FOA) is required and strictly enforced. Applicants
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must read and follow all application instructions in the Application Guide as
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well as any program-specific instructions noted in <a
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href="#_Section_IV._Application_1">Section IV</a>. When the program-specific
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instructions deviate from those in the Application Guide, follow the
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program-specific instructions. <b>Applications that do not comply with
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these instructions may be delayed or not accepted for review.</b></p>
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<br>
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<style>
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background-color: #4CAF50; /* Green */
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border: none;
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color: white;
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padding: 8px 16px;
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text-align: center;
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text-decoration: none;
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display: inline-block;
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font-size: 14px;
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}
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.important {
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color: #F00;
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font-weight: bold;
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font-size 14px;
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</style>
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<div class="heading1">Table of Contents</div>
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<p class=regulartext><a href="#_Part_1._Overview">Part 1. Overview Information</a><br>
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<a href="#_Part_2._Full">Part 2. Full Text of the Announcement</a></p>
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<p class=regulartext><span class=P_SingleIndent><a href="#_Section_I._Funding">Section
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I. Funding Opportunity Description</a></span><br>
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<span class=P_SingleIndent><a href="#_Section_II._Award_1">Section II. Award Information</a></span><br>
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<span class=P_SingleIndent><a href="#_Section_III._Eligibility">Section III. Eligibility Information</a></span><br>
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<span class=P_SingleIndent><a href="#_Section_IV._Application_1">Section IV. Application and Submission
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Information</a></span><br>
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<span class=P_SingleIndent><a href="#_Section_V._Application">Section V. Application Review Information</a></span><br>
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<span class=P_SingleIndent><a href="#_Section_VI._Award">Section VI. Award Administration Information</a></span><br>
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<span class=P_SingleIndent><a href="#_Section_VII._Agency">Section VII. Agency Contacts</a></span><br>
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<span class=P_SingleIndent><a href="#_Section_VIII._Other">Section VIII. Other Information</a></span></p>
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<div class="heading1"><a name="_Toc258873265"></a><a
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name="_Toc258852635"></a><br>
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<a name="_Part_2._Full"></a>Part 2.
|
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Full Text of Announcement</div>
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<div class="heading2"><a name="_Toc258873266"></a><a
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name="_Toc258852636"></a><a name=IFundOppDesc></a><a name="_Section_I._Funding"></a>Section I. Funding Opportunity Description</div>
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<p class=regulartext><a name="_Toc258873267"> </a></p>
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<div class="heading4">Purpose</div>
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<p class=regulartext>The purpose of this Funding Opportunity Announcement (FOA)
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is to support research to define the mechanisms regulating the establishment,
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development, and maintenance of immunity throughout childhood (from birth to
|
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less than 18 years of age), including the impact of pathogenic or commensal
|
|
microbes or vaccination against infectious diseases, allergens, and
|
|
environmental pollutants on immune ontogeny and function. This program will
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establish collaborations among a diverse set of experts (e.g., immunologists,
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neonatologists, pediatricians, systems biologists, and microbiologists) to
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investigate the dynamics and drivers of immune development, regulation, and
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function throughout childhood (birth to less than 18 years old). Studies may
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include SARS-CoV-2, cytomegalovirus (CMV), herpes simplex virus (HSV),
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congenital syphilis, human immunodeficiency virus or acquired immunodeficiency
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syndrome (HIV/AIDS), tuberculosis (Mycobacterium tuberculosis), and other
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infections that affect children within this age range. Awardees will partner
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with other researchers to conduct longitudinal studies of existing cohorts of
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mother-infant dyads and/or children and adolescents from birth to less than 18
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years of age. The ultimate goal of this program is to expand knowledge of
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immune development and functionality in children that will provide foundational
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information to improve immune health and vaccine efficacy in this vulnerable
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population.</p>
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<div class="heading4">Background</div>
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<p class=regulartext>Rapid changes occur during the development of the human
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immune system in early life when there is an increased risk of infection and
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associated morbidity and mortality. Globally, 85% of deaths among children and
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young adolescents in 2018 occurred in the first five years of life, accounting
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for 5.3 million deaths (WHO). Of these, 23% of neonatal deaths were due to
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infections such as sepsis, meningitis, pneumonia, tetanus, and diarrheal
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diseases. In contrast, in approximately 1 million children aged 5-14 years
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(WHO 2018 estimate), the leading causes of death included injuries and lower
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respiratory tract infections; by comparison, in the United States, adolescents
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and youth comprised approximately 21% of new HIV diagnoses. </p>
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<p class=regulartext>The immune system in children is distinct from that of
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adults and is characterized by a suboptimal response to infections and vaccines
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predominantly in the first two to three years of life. The current severe acute
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respiratory syndrome coronavirus-2 (SARS-CoV-2) pandemic, for example, has
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brought to light some differences in disease susceptibility, severity, and
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manifestation in children. While children of all ages may become ill with
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SARS-CoV-2, most do not develop severe disease. However, several infected
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children develop a condition known as multisystem inflammatory syndrome in
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children (MIS-C), a clinical presentation that is observed in children with a median
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age of 8 years, and infrequently reported in adolescents and adults. The
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ability of an infectious agent, like SARS-CoV-2, to induce distinct disease
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manifestations stratified by age highlights the importance of characterizing
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immune developmental and functional stages throughout childhood. In addition,
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while immune function in children appears to be sufficient to allow survival to
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adulthood, impaired responses to a range of pathogens and vaccines do result in
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susceptibility to severe disease in a significant proportion of this
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population. For example, young children are at increased risk of severe disease
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from influenza viruses, HIV, and other infections. Worldwide,
|
|
polysaccharide-encapsulated bacteria (Streptococcus pneumoniae, Hemophilus
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|
influenza type b and Neisseria meningitidis) are the leading causes of serious
|
|
bacterial infection in young children. Although vaccines are available to
|
|
protect against these organisms, a huge burden of disease and death is still
|
|
present. Furthermore, there are currently no vaccines for certain childhood
|
|
pathogens, such as respiratory syncytial virus, that commonly cause very
|
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serious infections in infants and young children. </p>
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<p class=regulartext>The immune differences that render young children
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susceptible to infections also reduce their immune responses to most vaccines.
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|
A mechanistic understanding of how immune ontogeny and functionality in early
|
|
life transitions from neonatal to adult functional capacity in the context of
|
|
vaccines or other preventive interventions remain to be clearly elucidated.
|
|
There is scant characterization of immune development in healthy young children
|
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beyond the first few years of life. Much remains to be learned about
|
|
age-dependent maturation of immune components in different populations. Whereas
|
|
longitudinal age-related changes in the numbers and function of immune cells in
|
|
tissues that include the skin, gut, and respiratory mucosae are beginning to be
|
|
investigated, functional maturation of different cell types (e.g., eosinophils,
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basophils), postnatal ontogeny of pattern recognition receptors and their
|
|
responses to cognate ligands, and environmental influences upon immune
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|
developmental processes require further investigation.</p>
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<p class=regulartext>A safe and effective HIV vaccine remains a critical need in
|
|
the fight against the HIV pandemic, especially to prevent emerging infections
|
|
in infants, adolescents, and young adults. Recent studies highlighting the
|
|
differences in immune responses between adults and children have suggested that
|
|
implementation of an HIV vaccine or non-vaccine biomedical HIV prevention
|
|
interventions during early life may afford an opportunity to protect prior to
|
|
the vulnerable period of adolescence and sexual debut. Studies evaluating viral
|
|
and bacterial vaccines also have shown that vaccine-induced immunity wanes
|
|
rapidly after vaccination in infancy and requires multiple booster injections
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to induce long-term protection. For example, routine diphtheria, tetanus
|
|
toxoid, acellular pertussis (DTaP) vaccination provides moderate protection
|
|
during the first year and wanes within the subsequent 2-3 years, reducing
|
|
protection from pertussis outbreaks in adolescents. Thus, understanding the
|
|
immunological mechanisms in children will help inform the design and
|
|
development of improved vaccine strategies that contribute to durable immune
|
|
responses and maintenance of immunological memory in these populations.</p>
|
|
|
|
|
|
|
|
<p class=regulartext>Different exposures early in life, such as a farm
|
|
environment, caesarean section, breast-feeding, birth history or environmental
|
|
pollutants can alter the risk of allergic diseases and asthma. Understanding
|
|
the impact of such exposures on immune function and potential immunological
|
|
mechanisms that either protect from or predispose to immune-mediated disease
|
|
would provide strategies for the development of preventive approaches. The
|
|
immune system can be a target for toxic effects caused by a wide variety of
|
|
environmental agents. Heavy metals, polychlorinated biphenyls (PCBs),
|
|
polybrominated biphenyls (PBBs), and certain air pollutants may cause immune
|
|
dysregulation and contribute to increased rates of immune-mediated or
|
|
infectious diseases. Children are susceptible to such perturbations that may
|
|
not necessarily lead to immediately detectable clinical manifestations.
|
|
Environmental factors may act on the host for many years before clinical
|
|
disease becomes apparent. Additionally, clinical disease may only become
|
|
evident after the immune system is challenged by other factors such as viral
|
|
infection. Although immune development has not been completely characterized,
|
|
there is increasing evidence that immune-associated diseases are dependent upon
|
|
specific windows of early life exposure, sex of the offspring, and epigenetic
|
|
influences among others. Children's susceptibility to environmental toxicants
|
|
such as per- and polyfluoroalkyl substances (PFAS) not only increases their
|
|
propensity for asthma in their youth, but may also affect vaccine responses as
|
|
adults, lowering their resistance to disease.</p>
|
|
|
|
|
|
|
|
<p class=regulartext>The Immunity in Neonates and Infants program began in 2012
|
|
and was renewed in 2017 to support U01 cooperative agreement awards. While the
|
|
program has supported several advances that contribute to our understanding of
|
|
the immune landscape in the first year of life, knowledge gaps remain. This
|
|
initiative, Immune Development in Early Life (IDEaL) (U19) and the companion
|
|
initiative, Immune Development in Early Life (IDEaL) (U01), collectively
|
|
referred to as the IDEaL research program, will facilitate a collaborative
|
|
effort with shared resources to address known gaps in knowledge and expand the
|
|
understanding of the fundamental mechanisms of immune maturation, function, and
|
|
regulation beyond the first year of life through adolescence. For example,
|
|
research might focus on studies that investigate how metabolic changes support
|
|
or influence immune cell function; explore mechanisms of immunological memory
|
|
in innate cells; address the role of epigenetic changes in regulating immune
|
|
development and function; and the application of new assays and technologies to
|
|
enable the assessment of immune cell populations and interactions in systems
|
|
that closely reflect their physiological environments.</p>
|
|
|
|
|
|
|
|
<div class="heading4">Research Objectives and Scope</div>
|
|
|
|
<p class=regulartext>The ultimate goal of the IDEaL
|
|
research program is to expand knowledge of immune development and functionality
|
|
in children that will provide foundational information to improve immune health
|
|
and vaccine efficacy in children from birth through adolescence (defined as
|
|
birth to less than 18 years of age). The program will support mechanistic,
|
|
hypothesis-driven studies that focus on defining fundamental aspects of immune
|
|
development and function in response to vaccines and other prevention
|
|
strategies, pathogenic infections, commensal microorganisms, allergens, and/or
|
|
environmental pollutants. Interdisciplinary research teams with expertise in
|
|
immunology, pediatrics, infectious diseases, vaccinology, and immune-mediated
|
|
diseases may be established to address areas of interest. It
|
|
is important to understand the development and function of the immune system
|
|
using longitudinal assessments, either through establishment and follow-up of a
|
|
new cohort or by following an established cohort over the course of several
|
|
years to understand how intrinsic and extrinsic exposures affect immune
|
|
maturation and functional capabilities. The population of interest for this FOA
|
|
are infants, children, and adolescents ages birth to less than 18 years, though
|
|
subsets within this age range can be the focus of a particular application.
|
|
Applications are expected to be integrated and synergistic, containing Research
|
|
Projects and Cores connected by a common theme that produce scientific gains
|
|
beyond those achievable if each project were performed independently. An
|
|
application may include different pathogens or commensal microbes, vaccines,
|
|
allergens, or environmental pollutants to investigate common immune pathways or
|
|
mechanisms; or may analyze different aspects of the immune response to the same
|
|
vaccine, infection, allergen, or environmental pollutant. Animal studies (small
|
|
and/or large animal models) may be included to extend or guide mechanistic
|
|
analyses of human samples; note that HIV research studies that include animal
|
|
models may only use non-human primates. </p>
|
|
|
|
|
|
|
|
<p class=regulartext>Examples of research areas of interest include, but are not
|
|
limited to:</p>
|
|
|
|
|
|
|
|
<ul>
|
|
<li>
|
|
Mechanisms regulating the generation and maintenance of T and B
|
|
cell memory;</li>
|
|
<li>
|
|
Molecular mechanisms of innate immunity, including trained
|
|
immunity;</li>
|
|
<li>
|
|
Effect of the microbiota on host immune development and response;</li>
|
|
<li>
|
|
Mechanisms of tissue-specific and mucosal immunity;</li>
|
|
<li>
|
|
Role and mechanisms of action of adjuvants/immune-potentiating
|
|
molecules or compounds for improving protective immune responses in children; </li>
|
|
<li>
|
|
Impact of sex differences on innate and adaptive immune
|
|
development and function;</li>
|
|
<li>
|
|
Impact of maternal factors on immune system development in early
|
|
life that include examination of longer-term effects in the child;</li>
|
|
<li>
|
|
Mechanism by which environmental exposures affect the
|
|
functionality of the pediatric immune system;</li>
|
|
<li>
|
|
Mechanisms regulating exhaustion of the immune response to
|
|
chronic infection or exposure, and impact on vaccine responses;</li>
|
|
<li>
|
|
Metabolic and/or epigenetic regulation of the pediatric immune
|
|
response;</li>
|
|
<li>
|
|
HIV:</li>
|
|
<li class="P_DoubleIndent">
|
|
Key factors impacting the pediatric immune response and efficacy
|
|
of HIV vaccine candidates and other HIV-prevention strategies;</li>
|
|
<li class="P_DoubleIndent">
|
|
Broadly neutralizing antibody development during pediatric immune
|
|
maturation;</li>
|
|
<li class="P_DoubleIndent">
|
|
Longitudinal imaging of immune cell dynamics and immune responses
|
|
to vaccines or other prevention strategies in the pediatric population;</li>
|
|
<li class="P_DoubleIndent">
|
|
Development of mucosal immunity in the context of
|
|
vaccine/prevention strategies;</li>
|
|
<li class="P_DoubleIndent">
|
|
Studies testing or proposing development of drugs/vaccines to
|
|
prevent infection that is specific to the pediatric population.</li>
|
|
</ul>
|
|
|
|
<p class=regulartext>Applications proposing the following studies or topic areas
|
|
will be considered non-responsive and will not be reviewed:</p>
|
|
|
|
|
|
|
|
<ul>
|
|
<li>
|
|
Studies in children with known genetic abnormalities, including
|
|
primary immunodeficiencies; children undergoing cancer chemotherapy; children
|
|
who are undergoing transplantation procedures; children with autoimmune
|
|
diseases, or receiving immunosuppressive therapy;</li>
|
|
<li>
|
|
Studies that focus on non-immune mechanisms of infectious
|
|
diseases (e.g., transmission, carriage, pathogenesis, or vaccine
|
|
development/testing) instead of immunological response mechanisms;</li>
|
|
<li>
|
|
Studies on exposures to alcohol, chemotherapeutic agents,
|
|
radiation (which is not a result of an ambient environmental exposure), drugs
|
|
of abuse, and pharmaceuticals;</li>
|
|
<li>
|
|
Clinical trials. However, analysis of samples from completed
|
|
clinical trials, samples obtained from clinical trials supported by other
|
|
mechanisms (e.g., SARS-CoV-2 or HIV vaccine studies supported by separate
|
|
grants or contracts) , or samples obtained from human subjects immunized with
|
|
licensed vaccines, where the vaccine is administered according to the product
|
|
label instructions, are permitted. A definition of clinical trials is available
|
|
at <a
|
|
href="https://grants.nih.gov/grants/glossary.htm#ClinicalTrial">https://grants.nih.gov/grants/glossary.htm#ClinicalTrial</a>;</li>
|
|
<li>
|
|
Genome-wide association studies (GWAS);</li>
|
|
<li>
|
|
Behavioral research;</li>
|
|
<li>
|
|
Studies that solely focus on characterization of microbiome;</li>
|
|
<li>
|
|
HIV studies focused on animal model development and animal models
|
|
other than non-human primates;</li>
|
|
<li>
|
|
Studies, other than HIV research, testing or proposing
|
|
development of drugs and/or vaccines to treat or prevent an infection;</li>
|
|
<li>
|
|
Studies that focus on individuals 18 years of age or older. However,
|
|
individuals 18 years of age or older may be included as a comparator for
|
|
younger age groups.</li>
|
|
</ul>
|
|
|
|
<div class="heading4">IDEaL Research Program Components</div>
|
|
|
|
<p class=regulartext><strong>Administrative
|
|
Core (required):</strong> The Administrative Core will be responsible
|
|
for the overall management, communication, coordination and supervision of the
|
|
program, including monitoring progress, developing and implementing a project
|
|
management plan, defining timelines, and overseeing adherence to compliance
|
|
with data sharing. The PDs/PIs of each U19 award will be responsible for the
|
|
development and implementation of a U19-wide Project Management Plan (PMP) to
|
|
assist with monitoring progress towards defined milestones based on the
|
|
research conducted within each U19. Additional professional staff may be
|
|
involved with development, implementation, monitoring and updating the PMP. </p>
|
|
|
|
|
|
|
|
<p class=regulartext><strong>Data
|
|
Management and Analysis Core (required):</strong> This core will be
|
|
responsible for providing central data storage, data management with safeguards
|
|
to protect the integrity of the data to all projects and cores within an IDEaL
|
|
U19 application, and will be responsible for ensuring the submission of data,
|
|
meta-data and related data analyses to the <a
|
|
href="https://www.immport.org/home">ImmPort</a> database, or other appropriate
|
|
public databases recommended by NIAID. This core will provide bioinformatics
|
|
expertise and data integration and analysis support, including computational
|
|
modeling if necessary, as well as study design and statistical
|
|
support/services, as needed. </p>
|
|
|
|
|
|
|
|
<p class=regulartext><strong>Service/Resource
|
|
Core(s) (optional):</strong> If proposed, Service Cores will support the
|
|
research projects with technologies or services that have already been
|
|
validated and refined for use (e.g. existing assays, reagents, technologies,
|
|
clinical, informatics or other services). A Service Core must be used by at
|
|
least two of the Research Projects. If proposed, Service Cores are limited to
|
|
no more than three per U19.</p>
|
|
|
|
|
|
|
|
<p class=regulartext><strong>Research
|
|
Projects (required):</strong> Each application must contain at least
|
|
two, but no more than three, research projects that should show synergy and be
|
|
organized around a common central theme and/or overall hypothesis. </p>
|
|
|
|
|
|
|
|
<p class=regulartext>Awardees under this FOA will participate in the IDEaL
|
|
Research Program including participation in the Annual Program Progress
|
|
Meetings, service on the IDEaL Steering Committee (and subcommittees), and
|
|
review by the External Scientific Group. These activities are described below.</p>
|
|
|
|
|
|
|
|
<p class=regulartext><a name="_Hlk49519432"><strong>IDEaL Annual Program Progress Meeting:</strong></a>
|
|
All awardees will participate in an annual one and a half to two-day
|
|
programmatic meeting arranged by NIH and held after award in the Rockville, MD
|
|
area. The purpose of these annual meetings is to discuss individual project
|
|
progress and foster collaborations among the PDs/PIs, scientific staff and
|
|
other program personnel funded by the IDEaL research program of U01 and U19
|
|
awardees. The annual meetings are open to investigators supported under this
|
|
FOA and to NIH extramural staff.</p>
|
|
|
|
|
|
|
|
<p class=regulartext><strong>IDEaL
|
|
Steering Committee:</strong> A Steering Committee (SC) will be
|
|
established by NIH to serve as the governing body of the IDEaL research
|
|
program. The purpose of the SC is to coordinate and facilitate the research
|
|
and activities of the IDEaL research program; review the progress of awardees;
|
|
identify scientific opportunities, emerging needs and challenges; ensure the
|
|
timely release of data through publications; facilitate access and use of <a
|
|
href="https://www.immport.org/home">ImmPort</a>; develop guidelines for the
|
|
publication of collaborative research program results; facilitate resource
|
|
sharing; prepare cumulative research program progress reports; promote
|
|
scientific collaboration and exchange of scientific findings among the
|
|
awardees; develop and implement sub-committees to facilitate and promote common
|
|
IDEaL-wide collaborations and procedural harmonizations such as data sharing,
|
|
data harmonization, integration and analyses; and to develop/follow policies
|
|
and procedures enacted by the SC with concurrence of the NIH Project
|
|
Scientist(s). </p>
|
|
|
|
|
|
|
|
<p class=regulartext>Membership of the SC will consist of individuals from the
|
|
U01 and U19 awards, NIH extramural staff, and other subject matter experts, as
|
|
determined by NIH. Awardees of the U01 will provide one PD/PI (only one individual
|
|
if multi-PDs/PIs leadership) and awardees of the U19 will provide one PD/PI
|
|
(only one individual if multi-PDs/PIs leadership) to serve as voting members of
|
|
the IDEaL Steering Committee. NIH extramural staff from the NIH ICs funding the
|
|
IDEaL research program will be non-voting members of the Steering Committee and
|
|
will participate in all Steering Committee activities. Members of the SC will
|
|
participate in all SC activities, and attend the Annual Program Progress
|
|
meeting, and other SC meetings or teleconferences, as determined by NIH. </p>
|
|
|
|
|
|
|
|
<p class=regulartext><strong>IDEaL
|
|
External Scientific Group:</strong> An External Scientific Group (ESG)
|
|
will be established by NIH in consultation with the IDEaL awardees to provide
|
|
external perspective and informed guidance for accomplishing the goals of the
|
|
program. The purpose of the ESG is to review progress and provide
|
|
recommendations to the awardees regarding the current status of the research,
|
|
the progress related to stated goals or outcomes, and address concerns about
|
|
the focus or direction of the research. The ESG members will attend the Annual
|
|
Program Progress meeting with awardees and NIH staff. <strong>DO NOT NAME OR CONTACT</strong>
|
|
potential members of the ESG either within the application (name) or before,
|
|
during or after application submission (contact), respectively. </p>
|
|
|
|
|
|
|
|
<p class=regulartext>See <span class=P_SingleIndent><a href="#_Section_VIII._Other">Section VIII. Other
|
|
Information</a></span> for award authorities and regulations.</p>
|
|
|
|
<div class="heading2"><a name="_Section_II._Award_1"></a>Section II. Award Information</div>
|
|
|
|
|
|
|
|
<table class=regulartextTable border=1 cellspacing=0 cellpadding=0 width="100%">
|
|
|
|
|
|
<div class="row">
|
|
<div class="col-md-4 datalabel">Funding Instrument</div>
|
|
<div class="col-md-8 datacolumn"><p class=regulartext>Cooperative Agreement: A support mechanism used when there
|
|
will be substantial Federal scientific or programmatic involvement.
|
|
Substantial involvement means that, after award, NIH scientific or project
|
|
staff will assist, guide, coordinate, or participate in project activities. See
|
|
Section VI.2 for additional information about the substantial involvement for
|
|
this FOA. </p></div>
|
|
</div><!--end row-->
|
|
|
|
|
|
<div class="row">
|
|
<div class="col-md-4 datalabel">Application Types Allowed</div>
|
|
<div class="col-md-8 datacolumn"><p class=regulartext>New <br>
|
|
<br>
|
|
</p>
|
|
<p class=regulartext>The <a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11116">OER
|
|
Glossary</a> and the SF424 (R&R) Application Guide provide details on
|
|
these application types. Only those application types listed here are allowed
|
|
for this FOA.</p></div>
|
|
</div><!--end row-->
|
|
|
|
|
|
<div class="row">
|
|
<div class="col-md-4 datalabel">Clinical Trial?</div>
|
|
<div class="col-md-8 datacolumn"><p class=regulartext>Not Allowed: Only accepting applications that do not
|
|
propose clinical trials</p>
|
|
|
|
<p class=regulartext><a
|
|
href="https://grants.nih.gov/grants/guide/url_redirect.htm?id=82370">Need
|
|
help determining whether you are doing a clinical trial?</a></p></div>
|
|
</div><!--end row-->
|
|
|
|
|
|
<div class="row">
|
|
<div class="col-md-4 datalabel">Funds Available and Anticipated Number of Awards</div>
|
|
<div class="col-md-8 datacolumn"><p class=regulartext>Issuing IC and partner <a
|
|
href="#_Components_of_Participating">component</a> intend to commit an
|
|
estimated total of $7.6M in FY 2022 to fund 2-3 awards.</p></div>
|
|
</div><!--end row-->
|
|
|
|
|
|
<div class="row">
|
|
<div class="col-md-4 datalabel">Award Budget</div>
|
|
<div class="col-md-8 datacolumn"><p class=regulartext>Application budgets are limited to $1.0 M in direct costs
|
|
per year and must reflect the actual needs of the proposed project. </p></div>
|
|
</div><!--end row-->
|
|
|
|
|
|
<div class="row">
|
|
<div class="col-md-4 datalabel">Award Project Period</div>
|
|
<div class="col-md-8 datacolumn"><p class=regulartext>The scope of the project should determine the project
|
|
period. The maximum project period is 5 years.</p></div>
|
|
</div><!--end row-->
|
|
</table>
|
|
|
|
|
|
|
|
|
|
<p class="regulartext" style="clear:both;">NIH grants policies as
|
|
described in the <a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11120"><i>NIH
|
|
Grants Policy Statement</i></a> will apply
|
|
to the applications submitted and awards made from this FOA.</p>
|
|
|
|
|
|
|
|
<div class="heading2"><a name="_Toc258873268"></a><a
|
|
name="_Section_III._Eligibility"></a>Section III. Eligibility
|
|
Information</div>
|
|
|
|
<div class="heading3">1. Eligible Applicants</div>
|
|
|
|
|
|
|
|
<div class="heading4">Eligible Organizations</div>
|
|
|
|
<p class=regulartext>Higher Education Institutions</p>
|
|
|
|
<ul>
|
|
<li>
|
|
Public/State Controlled Institutions of Higher Education </li>
|
|
<li>
|
|
Private Institutions of Higher Education </li>
|
|
</ul>
|
|
|
|
<p class=P_SingleIndent>The following types of Higher Education Institutions
|
|
are always encouraged to apply for NIH support as Public or Private
|
|
Institutions of Higher Education: </p>
|
|
|
|
<p class=P_DoubleIndent>o
|
|
Hispanic-serving Institutions</p>
|
|
|
|
<p class=P_DoubleIndent>o
|
|
Historically Black Colleges and Universities (HBCUs)</p>
|
|
|
|
<p class=P_DoubleIndent>o
|
|
Tribally Controlled Colleges and Universities (TCCUs) </p>
|
|
|
|
<p class=P_DoubleIndent>o
|
|
Alaska Native and Native Hawaiian Serving Institutions</p>
|
|
|
|
<p class=P_DoubleIndent>o
|
|
Asian American Native American Pacific Islander Serving
|
|
Institutions (AANAPISIs)</p>
|
|
|
|
|
|
|
|
<p class=regulartext>Nonprofits Other Than Institutions of Higher Education</p>
|
|
|
|
<ul>
|
|
<li>
|
|
Nonprofits with 501(c)(3) IRS Status (Other than Institutions of
|
|
Higher Education) </li>
|
|
<li>
|
|
Nonprofits without 501(c)(3) IRS Status (Other than Institutions
|
|
of Higher Education) </li>
|
|
</ul>
|
|
|
|
<p class=regulartext>For-Profit Organizations</p>
|
|
|
|
<ul>
|
|
<li>
|
|
Small Businesses</li>
|
|
<li>
|
|
For-Profit Organizations (Other than Small Businesses)</li>
|
|
</ul>
|
|
|
|
<p class=regulartext>Governments</p>
|
|
|
|
<ul>
|
|
<li>
|
|
State Governments </li>
|
|
<li>
|
|
County Governments</li>
|
|
<li>
|
|
City or Township Governments</li>
|
|
<li>
|
|
Special District Governments</li>
|
|
<li>
|
|
Indian/Native American Tribal Governments (Federally Recognized) </li>
|
|
<li>
|
|
Indian/Native American Tribal Governments (Other than Federally
|
|
Recognized)</li>
|
|
<li>
|
|
Eligible Agencies of the Federal Government</li>
|
|
<li>
|
|
U.S. Territory or Possession</li>
|
|
</ul>
|
|
|
|
<p class=regulartext>Other</p>
|
|
|
|
<ul>
|
|
<li>
|
|
Independent School Districts</li>
|
|
<li>
|
|
Public Housing Authorities/Indian Housing Authorities</li>
|
|
<li>
|
|
Native American Tribal Organizations (other than Federally
|
|
recognized tribal governments)</li>
|
|
<li>
|
|
Faith-based or Community-based Organizations</li>
|
|
<li>
|
|
Regional Organizations</li>
|
|
</ul>
|
|
|
|
<div class="heading4">Foreign Institutions</div>
|
|
|
|
<p class=regulartext>Non-domestic (non-U.S.) Entities (Foreign Institutions) <b>are
|
|
not</b> eligible to apply.<br>
|
|
Non-domestic (non-U.S.) components of U.S. Organizations <b>are </b> eligible
|
|
to apply.<br>Foreign components, as <a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11118">defined in
|
|
the <i>NIH Grants Policy Statement</i></a>, <b>are </b> allowed. </p>
|
|
|
|
|
|
|
|
<div class="heading4">Required Registrations</div>
|
|
|
|
<p class=regulartext><strong>Applicant
|
|
Organizations</strong></p>
|
|
|
|
<p class=regulartext>Applicant organizations must complete and maintain the
|
|
following registrations as described in the SF 424 (R&R) Application Guide
|
|
to be eligible to apply for or receive an award. All registrations must be
|
|
completed prior to the application being submitted. Registration can take 6
|
|
weeks or more, so applicants should begin the registration process as soon as
|
|
possible. The <a
|
|
href="//grants.nih.gov/grants/guide/notice-files/NOT-OD-15-039.html">NIH
|
|
Policy on Late Submission of Grant Applications</a> states that failure to
|
|
complete registrations in advance of a due date is not a valid reason for a
|
|
late submission.</p>
|
|
|
|
<ul>
|
|
<li>
|
|
<a href="http://fedgov.dnb.com/webform" Title="Link to Non-U.S. Government Site">Dun and Bradstreet
|
|
Universal Numbering System (DUNS)</a> - All registrations require that
|
|
applicants be issued a DUNS number. After obtaining a DUNS number, applicants
|
|
can begin both SAM and eRA Commons registrations. The same DUNS number must be
|
|
used for all registrations, as well as on the grant application.</li>
|
|
<li>
|
|
<a href="https://www.sam.gov/portal/public/SAM/">System for Award Management (SAM)</a>
|
|
Applicants must complete and maintain an active registration, <b>which
|
|
requires renewal at least annually</b>. 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. </li>
|
|
<li>o
|
|
<a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11176">NATO
|
|
Commercial and Government Entity (NCAGE) Code</a> Foreign organizations must
|
|
obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. </li>
|
|
<li>
|
|
<a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11123">eRA Commons</a> - Applicants
|
|
must have an active DUNS number to register in eRA Commons. Organizations can
|
|
register with the eRA Commons as they are working through their SAM or
|
|
Grants.gov registration, but all registrations must be in place by time of
|
|
submission. eRA Commons requires organizations to identify at least one Signing
|
|
Official (SO) and at least one Program Director/Principal Investigator (PD/PI)
|
|
account in order to submit an application. </li>
|
|
<li>
|
|
<a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=82300">Grants.gov</a> Applicants
|
|
must have an active DUNS number and SAM registration in order to complete the
|
|
Grants.gov registration. </li>
|
|
</ul>
|
|
|
|
<p class=regulartext><strong>Program
|
|
Directors/Principal Investigators (PD(s)/PI(s)) </strong></p>
|
|
|
|
<p class=regulartext>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 class="heading4">Eligible Individuals (Program Director/Principal
|
|
Investigator)</div>
|
|
|
|
<p class=regulartext>Any individual(s) with the skills, knowledge, and resources
|
|
necessary to carry out the proposed research as the Program Director(s)/Principal
|
|
Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to
|
|
develop an application for support. Individuals from underrepresented racial
|
|
and ethnic groups as well as individuals with disabilities are always encouraged
|
|
to apply for NIH support.</p>
|
|
|
|
|
|
|
|
<p class=regulartext>For institutions/organizations proposing multiple PDs/PIs, visit
|
|
the Multiple Program Director/Principal Investigator Policy and submission
|
|
details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R)
|
|
Application Guide. </p>
|
|
|
|
|
|
|
|
<p class=regulartext>An individual may serve as PD/PI on a single PD/PI
|
|
application or a PD/PI on a multi-PDs/PIs application on either an IDEaL U19 or
|
|
U01 application, but not both. PD/PIs may serve as Project leaders, Core
|
|
leaders or collaborators on an application where they are not the PD/PI on a
|
|
single PD/PI application or a PD/PI within a multiple PDs/PIs application. </p>
|
|
|
|
|
|
|
|
<div class="heading3">2. Cost Sharing</div>
|
|
|
|
<p class=regulartext>This FOA does not require cost sharing as defined in the <a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11126"><i>NIH
|
|
Grants Policy Statement</i>.</a></p>
|
|
|
|
|
|
|
|
<div class="heading3"><a name="_3._Additional_Information"></a>3. Additional Information on Eligibility</div>
|
|
|
|
<div class="heading4">Number of Applications</div>
|
|
|
|
<p class=regulartext>Applicant organizations may submit more than one application,
|
|
provided that each application is scientifically distinct. </p>
|
|
|
|
|
|
|
|
<p class=regulartext>The NIH will not accept duplicate or highly overlapping
|
|
applications under review at the same time. This means that the NIH will
|
|
not accept:</p>
|
|
|
|
<ul>
|
|
<li>
|
|
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>
|
|
A resubmission (A1) application that is submitted before issuance
|
|
of the summary statement from the review of the previous new (A0) application.</li>
|
|
<li>
|
|
An application that has substantial overlap with another
|
|
application pending appeal of initial peer review (see <a
|
|
href="https://grants.nih.gov/grants/guide/notice-files/not-od-11-101.html">NOT-OD-11-101</a>).</li>
|
|
</ul>
|
|
|
|
<p class=regulartext><a name="_Toc258873269"></a><a
|
|
name="_Section_IV._Application"></a> </p>
|
|
|
|
<div class="heading2"><a name="_Section_IV._Application_1"></a>Section IV. Application and Submission Information</div>
|
|
|
|
<div class="heading3">1. Requesting an
|
|
Application Package</div>
|
|
|
|
<p class=regulartext>The application forms package specific to this opportunity
|
|
must be accessed through ASSIST or an institutional system-to-system solution. A
|
|
button to apply using ASSIST is available in <a
|
|
href="#_Required_Application_Instructions">Part 1</a> of this FOA. See your
|
|
administrative office for instructions if you plan to use an institutional
|
|
system-to-system solution.</p>
|
|
|
|
|
|
|
|
<div class="heading3"><a name="_2._Content_and"></a>2. Content and Form of Application Submission</div>
|
|
|
|
|
|
|
|
<p class=regulartext>It is critical that applicants follow the Multi-Project (M) Instructions
|
|
in the <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=12000">SF424
|
|
(R&R) Application Guide</a>, except where instructed in this funding
|
|
opportunity announcement to do otherwise and where instructions in the
|
|
Application Guide are directly related to the Grants.gov downloadable forms
|
|
currently used with most NIH opportunities. Conformance to the requirements in
|
|
the Application Guide is required and strictly enforced. Applications that are
|
|
out of compliance with these instructions may be delayed or not accepted for
|
|
review.</p>
|
|
|
|
|
|
|
|
<div class="heading4">Letter of Intent </div>
|
|
|
|
<p class=regulartext>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 class=regulartext>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>
|
|
Number and title of this funding opportunity </li>
|
|
</ul>
|
|
|
|
|
|
|
|
<p class=regulartext>The letter of intent should be sent to: </p>
|
|
|
|
<p class=P_SingleIndent>Maggie Morris Fears, Ph.D.<br>
|
|
Telephone: 301-761-5444<br>
|
|
Email: <a href="/cdn-cgi/l/email-protection#d3beb2b4b4bab6fdbebca1a1baa0b5b6b2a1a093bdbabbfdb4bca5"><span class="__cf_email__" data-cfemail="d7bab6b0b0beb2f9bab8a5a5bea4b1b2b6a5a497b9bebff9b0b8a1">[email protected]</span></a>
|
|
</p>
|
|
|
|
|
|
|
|
<div class="heading4">Page Limitations</div>
|
|
|
|
|
|
|
|
<table class=regulartextTable border=1 cellspacing=0 cellpadding=0>
|
|
<thead>
|
|
<tr>
|
|
<td width=355 valign=top>
|
|
<p class=regulartext><strong>Available
|
|
Component Types </strong></p>
|
|
</td>
|
|
<td width=216 valign=top>
|
|
<p class=regulartext><strong>Research
|
|
Strategy/Project Plan Page Limits</strong></p>
|
|
</td>
|
|
</tr>
|
|
</thead>
|
|
<tr>
|
|
<td width=355 valign=top>
|
|
<p class=regulartext>Overall</p>
|
|
</td>
|
|
<td width=216 valign=top>
|
|
<p class=regulartext>12</p>
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td width=355 valign=top>
|
|
<p class=regulartext>Administrative Core</p>
|
|
</td>
|
|
<td width=216 valign=top>
|
|
<p class=regulartext>6</p>
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td width=355 valign=top>
|
|
<p class=regulartext>Data Management and Analysis Core</p>
|
|
</td>
|
|
<td width=216 valign=top>
|
|
<p class=regulartext>6</p>
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td width=355 valign=top>
|
|
<p class=regulartext>Service/Resource Core(s) (optional)</p>
|
|
</td>
|
|
<td width=216 valign=top>
|
|
<p class=regulartext>6 (each)</p>
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td width=355 valign=top>
|
|
<p class=regulartext>Research Project(s)</p>
|
|
</td>
|
|
<td width=216 valign=top>
|
|
<p class=regulartext>12 (each)</p>
|
|
</td>
|
|
</tr>
|
|
</table>
|
|
|
|
|
|
|
|
<p class=regulartext>Additional page limits described in the SF424 Application
|
|
Guide and the <a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11133">Table of
|
|
Page Limits</a> must be followed.</p>
|
|
|
|
|
|
|
|
<div class="heading4">Instructions for the Submission of Multi-Component Applications</div>
|
|
|
|
<p class=regulartext>The following section supplements the instructions found in
|
|
the SF424 (R&R) Application Guide, and should be used for preparing a
|
|
multi-component application. </p>
|
|
|
|
|
|
|
|
<p class=regulartext>The application should consist of the following components:</p>
|
|
|
|
<ul>
|
|
<li>
|
|
Overall: required</li>
|
|
<li>
|
|
Administrative Core: required, maximum 1</li>
|
|
<li>
|
|
Data Management and Analysis Core: required, maximum 1</li>
|
|
<li>
|
|
Service/Resource Core(s): optional, maximum 3 (each core must
|
|
support at least two Projects)</li>
|
|
<li>
|
|
Research Projects: required, minimum 2, maximum 3</li>
|
|
</ul>
|
|
|
|
<div class="heading4">Overall Component</div>
|
|
|
|
<p class=regulartext>When preparing your application, use Component Type
|
|
Overall .</p>
|
|
|
|
|
|
|
|
<p class=regulartext>All instructions in the SF424 (R&R) Application Guide
|
|
must be followed, with the following additional instructions, as noted.</p>
|
|
|
|
|
|
|
|
<div class="heading4Indent">SF424 (R&R) Cover (Overall)</div>
|
|
|
|
<p class=P_SingleIndent>Complete entire form. </p>
|
|
|
|
|
|
|
|
<div class="heading4Indent">PHS 398 Cover Page Supplement (Overall)</div>
|
|
|
|
<p class=P_SingleIndent>Note: Human Embryonic Stem Cell
|
|
lines from other components should be repeated in cell line table in Overall
|
|
component. </p>
|
|
|
|
|
|
|
|
<div class="heading4Indent">Research & Related Other
|
|
Project Information (Overall)</div>
|
|
|
|
<p class=P_SingleIndent>Follow standard instructions. </p>
|
|
|
|
|
|
<div class="heading4Indent">Project/Performance Site
|
|
Location(s) (Overall)</div>
|
|
|
|
<p class=P_SingleIndent>Enter primary site only. </p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent><i>A summary of Project/Performance
|
|
Sites in the Overall section of the assembled application image in eRA Commons
|
|
compiled from data collected in the other components will be generated upon
|
|
submission.</i></p>
|
|
|
|
|
|
|
|
<div class="heading4Indent">Research & Related
|
|
Senior/Key Person Profile (Overall)</div>
|
|
|
|
<p class=P_SingleIndent>Include only the Project
|
|
Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to
|
|
this FOA) for the entire application. </p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent><i>A summary of Senior/Key Persons
|
|
followed by their Biographical Sketches in the Overall section of the assembled
|
|
application image in eRA Commons will be generated upon submission.</i></p>
|
|
|
|
|
|
|
|
<div class="heading4Indent">Budget (Overall)</div>
|
|
|
|
<p class=P_SingleIndent>The only budget information
|
|
included in the Overall component is the Estimated Project Funding section of
|
|
the SF424 (R&R) Cover. </p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent><i>A budget summary in the Overall
|
|
section of the assembled application image in eRA Commons compiled from
|
|
detailed budget data collected in the other components will be generated upon
|
|
submission.</i></p>
|
|
|
|
<p class=P_SingleIndent> </p>
|
|
|
|
<div class="P_SingleIndent">PHS 398 Research Plan (Overall)</div>
|
|
|
|
<p class=P_SingleIndent><strong> </strong></p>
|
|
|
|
<p class=P_SingleIndent><b>Specific Aims: </b> Describe the
|
|
central scientific theme of the proposed research program and list the broad,
|
|
long-range objectives and goals of the proposed overall program. </p>
|
|
|
|
<p class=P_SingleIndent><b> </b></p>
|
|
|
|
<p class=P_SingleIndent><b>Research Strategy: </b>This narrative section summarizes
|
|
the overall research plan for the multi-project application and explains how
|
|
the proposed research supports mechanistic studies on the development,
|
|
regulation, and function of human immune responses and fulfils the purpose and
|
|
objectives of this FOA. Describe the central theme of the proposed project and
|
|
explain how the proposed Research Projects are synergistic and fit under the
|
|
overarching project theme. The multi-project application should be viewed as a
|
|
confederation of interrelated projects, each capable of standing on its own
|
|
scientific merit, but complementary to one another. This is an important
|
|
section for it provides the group of investigators an opportunity to give
|
|
conceptual wholeness to the overall program by giving a statement of the general
|
|
problem area and by laying out a broad strategy for addressing the problems. As
|
|
the strategy develops, each project and core should be cited briefly as to its
|
|
place in the overall scheme. Briefly summarize the special features in the
|
|
environment and/or resources that make this application strong or unique. As
|
|
applicable, describe the synergy and collaborations that are expected to occur.
|
|
To highlight program synergy, applicants may describe how the individual
|
|
components (research projects and shared service/resource cores) will be
|
|
coordinated and work together to address the overall goals and aims of the
|
|
program, and indicate collaborations, shared expertise, and leveraging of
|
|
resources, as applicable. In addition, applicants may address optimizing interactions
|
|
between projects and cores to achieve specific objectives of the research
|
|
program. </p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent>Include a schematic overview of the interactions and
|
|
collaborations among the components (projects and cores), indicate
|
|
collaborations among members and relevant publications co-authored by members
|
|
of the program. Project synergy may also be addressed in other sections of the
|
|
application, as appropriate.</p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent><b>Letters of Support: </b> Provide
|
|
any institutional letters of support specific to the Overall Component. </p>
|
|
|
|
<p class=P_SingleIndent><strong> </strong></p>
|
|
|
|
<p class=P_SingleIndent><strong>Resource
|
|
Sharing Plan:</strong> Individuals are required to comply with the
|
|
instructions for the Resource Sharing Plans as provided in the SF424 (R&R)
|
|
Application Guide, with the following modification:</p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent>All applications, regardless of the amount of direct
|
|
costs requested for any one year, should address a Data Sharing Plan.</p>
|
|
|
|
<p class=P_SingleIndent> </p>
|
|
|
|
<p class=P_SingleIndent>Awardees will be expected to deposit data and data
|
|
analyses into <a href="https://www.immport.org/home" Title="Link to Non-U.S. Government Site">ImmPort</a> or other
|
|
public data portal as designated by NIAID. </p>
|
|
|
|
<p class=P_SingleIndent> </p>
|
|
|
|
<p class=P_SingleIndent><b>Appendix:</b></p>
|
|
|
|
<p class=P_SingleIndent>Only limited items are allowed in the Appendix. Follow
|
|
all instructions for the Appendix as described in the SF424 (R&R)
|
|
Application Guide; any instructions provided here are in addition to the SF424
|
|
(R&R) Application Guide instructions. </p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent>PHS Human Subjects and Clinical
|
|
Trials Information (Overall)</p>
|
|
|
|
<p class=P_SingleIndent>When involving human subjects research, clinical
|
|
research, and/or NIH-defined clinical trials follow all instructions for the
|
|
PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R)
|
|
Application Guide, with the following additional instructions:</p>
|
|
|
|
<p class=P_SingleIndent> </p>
|
|
|
|
<p class=P_SingleIndent>If you answered Yes to the question Are Human
|
|
Subjects Involved? on the R&R Other Project Information form, there must
|
|
be at least one human subjects study record using the<strong> Study Record: PHS Human Subjects and
|
|
Clinical Trials Information</strong> form or a <strong>Delayed Onset Study</strong>
|
|
record within the application. The study record(s) must be included in the
|
|
component(s) where the work is being done, unless the same study spans multiple
|
|
components. To avoid the creation of duplicate study records, a single study
|
|
record with sufficient information for all involved components must be included
|
|
in the Overall component when the same study spans multiple components. </p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent><strong>Study
|
|
Record: PHS Human Subjects and Clinical Trials Information</strong></p>
|
|
|
|
<p class=P_SingleIndent>All instructions in the SF424
|
|
(R&R) Application Guide must be followed </p>
|
|
|
|
<p class=P_SingleIndent> </p>
|
|
|
|
<p class=P_SingleIndent><strong>Delayed
|
|
Onset Study</strong></p>
|
|
|
|
<p class=P_SingleIndent>Note: <a
|
|
href="https://grants.nih.gov/grants/glossary.htm#DelayedOnsetHumanSubjectStudy">Delayed
|
|
onset</a> does NOT apply to a study that can be described but will not start
|
|
immediately (i.e., delayed start).</p>
|
|
|
|
<p class=P_SingleIndent>All instructions in the SF424
|
|
(R&R) Application Guide must be followed </p>
|
|
|
|
<p class=P_SingleIndent> </p>
|
|
|
|
<div class="P_SingleIndent">PHS Assignment Request
|
|
Form (Overall)</div>
|
|
|
|
<p class=P_SingleIndent>All instructions in the SF424
|
|
(R&R) Application Guide must be followed. </p>
|
|
|
|
<p class=P_SingleIndent> </p>
|
|
|
|
<div class="heading4">Administrative Core</div>
|
|
|
|
<p class=regulartext>When preparing your application, use Component Type Admin Core
|
|
. </p>
|
|
|
|
|
|
|
|
<p class=regulartext>All instructions in the SF424 (R&R) Application Guide
|
|
must be followed, with the following additional instructions, as noted.</p>
|
|
|
|
|
|
|
|
<div class="heading4Indent">SF424 (R&R) Cover (<a
|
|
name="_Hlk54358165">Administrative</a> Core)</div>
|
|
|
|
<p class=P_SingleIndent>Complete only the following fields:</p>
|
|
|
|
<ul>
|
|
<li>
|
|
Applicant Information</li>
|
|
<li>
|
|
Type of Applicant (optional)</li>
|
|
<li>
|
|
Descriptive Title of Applicant’s Project</li>
|
|
<li>
|
|
Proposed Project Start/Ending Dates</li>
|
|
</ul>
|
|
|
|
<div class="heading4Indent">PHS 398 Cover Page Supplement (Administrative
|
|
Core)</div>
|
|
|
|
<p class=P_SingleIndent>Enter Human Embryonic Stem Cells in
|
|
each relevant component.</p>
|
|
|
|
|
|
|
|
<div class="heading4Indent">Research & Related Other
|
|
Project Information (Administrative Core)</div>
|
|
|
|
<p class=P_SingleIndent><b>Human Subjects:</b> Answer only
|
|
the Are Human Subjects Involved? and 'Is the Project Exempt from Federal
|
|
regulations? questions.</p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent><b>Vertebrate Animals:</b> Answer
|
|
only the Are Vertebrate Animals Used? question.</p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent><b>Project Narrative: </b>Do not
|
|
complete. Note: ASSIST screens will show an asterisk for this attachment
|
|
indicating it is required. However, eRA systems only enforce this requirement
|
|
in the Overall component and applications will not receive an error if omitted
|
|
in other components.</p>
|
|
|
|
|
|
|
|
<div class="heading4Indent">Project /Performance Site
|
|
Location(s) (Administrative Core)</div>
|
|
|
|
<p class=P_SingleIndent>List all performance sites that
|
|
apply to the specific component.</p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent><i>Note: <em>The Project Performance</em>
|
|
Site form allows up to 300 sites, prior to using additional attachment for
|
|
additional entries.</i></p>
|
|
|
|
|
|
<div class="heading4Indent">Research & Related
|
|
Senior/Key Person Profile (Administrative Core)</div>
|
|
|
|
<ul>
|
|
<li>
|
|
In the Project Director/Principal Investigator section of the
|
|
form, use Project Role of Other with Category of Core Lead and provide a
|
|
valid eRA Commons ID in the Credential field.</li>
|
|
<li>
|
|
In the additional Senior/Key Profiles section, list Senior/Key
|
|
persons that are working in the component.</li>
|
|
<li>
|
|
Include a single Biographical Sketch for each Senior/Key person
|
|
listed in the application regardless of the number of components in which they
|
|
participate. When a Senior/Key person is listed in multiple components, the
|
|
Biographical Sketch can be included in any one component.</li>
|
|
<li>
|
|
If more than 100 Senior/Key persons are included in a component,
|
|
the Additional Senior Key Person attachments should be used. </li>
|
|
</ul>
|
|
|
|
<div class="heading4Indent">Budget (Administrative Core)</div>
|
|
|
|
<p class=P_SingleIndent>Budget forms appropriate for the
|
|
specific component will be included in the application package.</p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent>Within the budget, applicants should request funds
|
|
for the following:</p>
|
|
|
|
|
|
|
|
<ul>
|
|
<li>
|
|
Travel of the PDs/PIs, Administrative Core Leader (unless the
|
|
same as PDs/PIs) and other required personnel to participate in the Annual
|
|
Program Progress meeting (one 2-day meeting per year to be held in the
|
|
Rockville, MD area). Applicants may propose travel funds only for attendance at
|
|
program meetings related to this FOA.</li>
|
|
<li>
|
|
Include funds for the overall administrative effort, including
|
|
administrative services, such as a Project Manager or Administrative Assistant
|
|
responsible for day to day administrative management of the award,
|
|
collaborative activities, communications, and publications. </li>
|
|
</ul>
|
|
|
|
<p class=P_SingleIndent><i>Note: The R&R Budget form
|
|
included in many of the component types allows for up to 100 Senior/Key Persons
|
|
in section A and 100 Equipment Items in section C prior to using attachments
|
|
for additional entries. All other SF424 (R&R) instructions apply.</i></p>
|
|
|
|
|
|
|
|
<div class="heading4Indent">PHS 398 Research Plan (Administrative
|
|
Core)</div>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent><b>Specific Aims:</b> List in priority
|
|
order the proposed activities and services of the Administrative Core.
|
|
Concisely describe the work to be completed to address issues of program
|
|
coordination, communication, and management.</p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent><b>Research Strategy: </b> </p>
|
|
|
|
<ul>
|
|
<li>
|
|
Describe the organizational and administrative structure, and a
|
|
complete staffing plan for the proposed research program. Include plans on how
|
|
the scientific and administrative leadership of the U19 will interact with Project
|
|
and Core Leaders to exchange information about progress, performance issues and
|
|
other matters related to the functional requirements of the U19.</li>
|
|
<li>
|
|
Describe specific opportunities for coordination, administration
|
|
and collaboration among leaders and staff. </li>
|
|
<li>
|
|
Provide an administrative plan that includes a discussion of the
|
|
structure and roles of administrative staff, including the functions to be performed,
|
|
how fiscal and other resources will be prioritized, allocated and managed, how communications
|
|
will be facilitated; how conflict resolution will be attained; how research
|
|
related travel and training will be managed. Present a leadership succession
|
|
plan. </li>
|
|
<li>
|
|
Discuss how the staffing plan for the Administrative Core
|
|
incorporates anticipated needs for professional staff to serve as effective
|
|
administrators for specific functions. </li>
|
|
<li>
|
|
Describe how the Project Management Plan (PMP) will be developed,
|
|
implemented, monitored and updated. In addition, describe how the PMP will be
|
|
used to track and monitor the proposed timelines and milestones, and how this
|
|
plan will inform the PDs/PIs, Core Leaders and other project staff about
|
|
progress and timeliness in achieving progress towards individual and collective
|
|
goals. Describe general plans for PMP staffing to ensure effective project
|
|
management for the U19. </li>
|
|
</ul>
|
|
|
|
<p class=P_SingleIndent><b>Letters of Support:</b> Provide
|
|
any institutional letters of support specific to the Administrative Core.</p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent><b>Resource Sharing Plan:</b> Individuals are
|
|
required to comply with the instructions for the Resource Sharing Plans as
|
|
provided in the SF424 (R&R) Application Guide, with the following
|
|
modification:</p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent>All applications, regardless of the amount of direct
|
|
costs requested for any one year, should address a Data Sharing Plan.</p>
|
|
|
|
<p class=P_SingleIndent>Awardees will be expected to deposit data and data
|
|
analyses into <a href="https://www.immport.org/home" Title="Link to Non-U.S. Government Site">ImmPort</a> or other
|
|
public data portal as designated by NIAID. </p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent><b>Appendix:</b> </p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent>Only limited items are allowed in the Appendix. Follow
|
|
all instructions for the Appendix as described in the SF424 (R&R)
|
|
Application Guide; any instructions provided here are in addition to the SF424
|
|
(R&R) Application Guide instructions. </p>
|
|
|
|
|
|
|
|
<div class="heading4Indent">PHS Human Subjects and Clinical Trials Information
|
|
(Administrative Core)</div>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent>When involving human subjects research, clinical
|
|
research, and/or NIH-defined clinical trials follow all instructions for the
|
|
PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R)
|
|
Application Guide, with the following additional instructions:</p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent>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 a <strong>Delayed Onset Study</strong>
|
|
record.</p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent><strong>Study
|
|
Record: PHS Human Subjects and Clinical Trials Information</strong></p>
|
|
|
|
<p class=P_SingleIndent>All instructions in the SF424
|
|
(R&R) Application Guide must be followed </p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent><strong>Delayed
|
|
Onset Study</strong></p>
|
|
|
|
<p class=P_SingleIndent>Note: <a
|
|
href="https://grants.nih.gov/grants/glossary.htm#DelayedOnsetHumanSubjectStudy">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 SF424 (R&R)
|
|
Application Guide must be followed </p>
|
|
|
|
|
|
|
|
<div class="heading4">Data Management and Analysis Core </div>
|
|
|
|
<p class=regulartext>When preparing your application, use Component Type Core. </p>
|
|
|
|
|
|
|
|
<p class=regulartext>All instructions in the SF424 (R&R) Application Guide
|
|
must be followed, with the following additional instructions, as noted.</p>
|
|
|
|
|
|
|
|
<div class="heading4Indent">SF424 (R&R) Cover (Data Management and Analysis Core
|
|
)</div>
|
|
|
|
<p class=P_SingleIndent>Complete only the following fields:</p>
|
|
|
|
<ul>
|
|
<li>
|
|
Applicant Information</li>
|
|
<li>
|
|
Type of Applicant (optional)</li>
|
|
<li>
|
|
Descriptive Title of Applicant’s Project</li>
|
|
<li>
|
|
Proposed Project Start/Ending Dates</li>
|
|
</ul>
|
|
|
|
|
|
|
|
<div class="heading4Indent">PHS 398 Cover Page Supplement (Data Management and
|
|
Analysis Core)</div>
|
|
|
|
<p class=P_SingleIndent>Enter Human Embryonic Stem Cells in each relevant component.</p>
|
|
|
|
|
|
|
|
<div class="heading4Indent">Research & Related Other Project Information (Data
|
|
Management and Analysis Core)</div>
|
|
|
|
<p class=P_SingleIndent><strong>Human
|
|
Subjects:</strong> Answer only the Are Human Subjects Involved? and
|
|
'Is the Project Exempt from Federal regulations? questions.</p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent><strong>Vertebrate
|
|
Animals</strong>: Answer only the Are Vertebrate Animals Used?
|
|
question.</p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent><strong>Project
|
|
Narrative:</strong> Do not complete. Note: ASSIST screens will show an
|
|
asterisk for this attachment indicating it is required. However, eRA systems
|
|
only enforce this requirement in the Overall component and applications will
|
|
not receive an error if omitted in other components.</p>
|
|
|
|
|
|
|
|
<div class="heading4Indent">Project/Performance Site Location(s) (Data Management and
|
|
Analysis Core)</div>
|
|
|
|
<p class=P_SingleIndent>List all performance sites that apply to the specific
|
|
component.</p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent>Note: The Project Performance Site form allows up to 300
|
|
sites, prior to using additional attachment for additional entries.</p>
|
|
|
|
|
|
<div class="heading4Indent">Research & Related Senior/Key Person Profile (Data
|
|
Management and Analysis Core)</div>
|
|
|
|
<p class=P_SingleIndent>ASSIST will default to Core Lead . If you would like to use
|
|
a different category, then replace Project Lead below with a different
|
|
Category (e.g., Core Lead). </p>
|
|
|
|
<ul>
|
|
<li>
|
|
In the Project Director/Principal Investigator section of the
|
|
form, use Project Role of Other with Category of Core Lead and provide a
|
|
valid eRA Commons ID in the Credential field.</li>
|
|
<li>
|
|
In the additional Senior/Key Profiles section, list Senior/Key
|
|
persons that are working in the component.</li>
|
|
<li>
|
|
Include a single Biographical Sketch for each Senior/Key person
|
|
listed in the application regardless of the number of components in which they
|
|
participate. When a Senior/Key person is listed in multiple components, the
|
|
Biographical Sketch can be included in any one component.</li>
|
|
<li>
|
|
If more than 100 Senior/Key persons are included in a component,
|
|
the Additional Senior Key Person attachments should be used. </li>
|
|
</ul>
|
|
|
|
|
|
|
|
<div class="heading4Indent">Budget (Data Management and Analysis Core)</div>
|
|
|
|
<p class=P_SingleIndent>Budget forms appropriate for the specific component will be
|
|
included in the application package. </p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent>Within the budget section, applicants
|
|
should request funds to support the following: </p>
|
|
|
|
|
|
|
|
<ul>
|
|
<li>
|
|
Central data storage, data management, safeguards to protect the
|
|
integrity of the data for all projects and cores, and submission of data and
|
|
data analyses to <a href="https://www.immport.org/home" Title="Link to Non-U.S. Government Site">ImmPort</a> or other
|
|
databases designated by NIAID. </li>
|
|
<li>
|
|
Travel for the Data Management and Analysis Core Leader (or their
|
|
representative) and other required Core personnel to participate in the Annual
|
|
Program Progress meeting (one 2-day meeting per year to be held in the
|
|
Rockville, MD area). Applicants may propose travel funds only for attendance at
|
|
program meetings related to this FOA.</li>
|
|
</ul>
|
|
|
|
<p class=P_SingleIndent>Note: The R&R Budget form included in many of the
|
|
component types allows for up to 100 Senior/Key Persons in section A and 100
|
|
Equipment Items in section C prior to using attachments for additional entries.
|
|
All other SF424 (R&R) instructions apply.</p>
|
|
|
|
|
|
|
|
<div class="heading4Indent">PHS 398 Research Plan (Data Management and Analysis Core)</div>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent><strong>Specific
|
|
Aims:</strong> List
|
|
in priority order the proposed activities and services of the Core. Clearly
|
|
describe the relationship of the Core to the overall U19 goals and how the
|
|
proposed activities relate to the other research projects and cores.</p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent><strong>Research
|
|
Strategy: </strong></p>
|
|
|
|
<ul>
|
|
<li>
|
|
Describe the overall function of the Core and describe how the
|
|
services of this Core will support and advance the outcomes from the proposed
|
|
research program.</li>
|
|
<li>
|
|
Explain the role of this Core in the research program. Discuss
|
|
how the Core Leadership will support and facilitate data management, data
|
|
analysis, and data sharing. </li>
|
|
<li>
|
|
Discuss the staffing plans that will support the functions
|
|
associated with this Core, including any professional staff or staff with
|
|
specialized skills to fully address the extent of Core needs. </li>
|
|
<li>
|
|
Describe the processes, procedures, methods and plans to provide
|
|
the bioinformatics infrastructure support for the following: </li>
|
|
</ul>
|
|
|
|
<p class=P_SingleIndent> </p>
|
|
|
|
<ul>
|
|
<li>
|
|
Statistical consideration of study design;</li>
|
|
<li>
|
|
Data collection, cleaning, and tracking;</li>
|
|
<li>
|
|
Database infrastructure;</li>
|
|
<li>
|
|
Information management and monitoring; </li>
|
|
<li>
|
|
Management of complex cross-sectional or longitudinal data;</li>
|
|
<li>
|
|
Computational modeling (as needed);</li>
|
|
<li>
|
|
Data-sharing, as appropriate;</li>
|
|
<li>
|
|
Sample size and power calculations;</li>
|
|
<li>
|
|
Statistical analysis and data integration methods.</li>
|
|
|
|
<li>
|
|
Describe how the Core staff will apply meaningful data or
|
|
statistical analyses to ensure studies (especially those with small sample
|
|
sizes, or descriptive data) are adequately powered and interpreted. If primary
|
|
study results will be descriptive in nature, the methods that are used should
|
|
ensure sufficient precision in the proposed estimates. If primary hypotheses
|
|
are being formally tested, applicants must demonstrate sufficient statistical
|
|
power to elucidate key differences that support these primary hypotheses.</li>
|
|
<li>
|
|
For clinical studies, applicants should provide specific
|
|
statistical design and power information under the PHS Human Subjects and
|
|
Clinical Trials Information and these should not be duplicated under the
|
|
Research Strategy. </li>
|
|
</ul>
|
|
|
|
<p class=P_SingleIndent><strong>Letters
|
|
of Support:</strong> Provide any letters of support from collaborators
|
|
that are specific to the Data Management and Analysis Core.</p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent><strong>Resource
|
|
Sharing Plan:</strong> Individuals are required to comply with the
|
|
instructions for the Resource Sharing Plans as provided in the SF424 (R&R)
|
|
Application Guide, with the following modification:</p>
|
|
|
|
|
|
|
|
<ul>
|
|
<li>
|
|
All applications, regardless of the amount of direct costs
|
|
requested for any one year, should provide a Data Sharing Plan. <a
|
|
name="_Hlk54351089">As part of the plan, applicants should detail the
|
|
procedures for sharing, release, and access of data, tools, models, reagents,
|
|
and other resources generated under this project to the broader scientific
|
|
community in adherence to the requirements and timelines described in the NIAID
|
|
Data and Reagents Sharing and Release Guidelines (</a><a
|
|
href="https://www.niaid.nih.gov/research/data-sharing-and-release-guidelines">https://www.niaid.nih.gov/research/data-sharing-and-release-guidelines</a>)
|
|
and the NIH Genomic Data Sharing (GDS) Policy (<a
|
|
href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-124.html">https://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-124.html</a>).</li>
|
|
<li>
|
|
Awardees will be expected to deposit data and data analyses into <a
|
|
href="https://www.immport.org/home">ImmPort</a> or other public data portals as
|
|
designated by NIAID. </li>
|
|
</ul>
|
|
|
|
<p class=P_SingleIndent><strong>Appendix:
|
|
</strong></p>
|
|
|
|
<p class=P_SingleIndent>Only limited items are allowed in the Appendix. Follow
|
|
all instructions for the Appendix as described in the SF424 (R&R)
|
|
Application Guide; any instructions provided here are in addition to the SF424
|
|
(R&R) Application Guide instructions. </p>
|
|
|
|
|
|
|
|
<div class="heading4Indent">PHS Human Subjects and Clinical Trials Information (Data
|
|
Management and Analysis Core )</div>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent>When involving human subjects research, clinical
|
|
research, and/or NIH-defined clinical trials follow all instructions for the
|
|
PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R)
|
|
Application Guide, with the following additional instructions:</p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent>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 a <strong>Delayed Onset Study</strong>
|
|
record.</p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent><strong>Study
|
|
Record: PHS Human Subjects and Clinical Trials Information</strong></p>
|
|
|
|
<p class=P_SingleIndent>All instructions in the SF424 (R&R) Application
|
|
Guide must be followed </p>
|
|
|
|
|
|
<p class=P_SingleIndent><strong>Delayed
|
|
Onset Study</strong></p>
|
|
|
|
<p class=P_SingleIndent>Note: <a
|
|
href="https://grants.nih.gov/grants/glossary.htm#DelayedOnsetHumanSubjectStudy">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 SF424 (R&R)
|
|
Application Guide must be followed </p>
|
|
|
|
|
|
|
|
<div class="heading4">Service/Resource Core (Optional)</div>
|
|
|
|
<p class=regulartext>When preparing your application, use Component Type Core. </p>
|
|
|
|
|
|
|
|
<p class=regulartext>All instructions in the SF424 (R&R) Application Guide
|
|
must be followed, with the following additional instructions, as noted.</p>
|
|
|
|
|
|
|
|
<div class="heading4Indent">SF424 (R&R) Cover (Service/Resource Core)</div>
|
|
|
|
<p class=P_SingleIndent>Complete only the following fields:</p>
|
|
|
|
<ul>
|
|
<li>
|
|
Applicant Information</li>
|
|
<li>
|
|
Type of Applicant (optional)</li>
|
|
<li>
|
|
Descriptive Title of Applicant’s Project</li>
|
|
<li>
|
|
Proposed Project Start/Ending Dates</li>
|
|
</ul>
|
|
|
|
|
|
<div class="heading4Indent">PHS 398 Cover Page Supplement (Service/Resource Core)</div>
|
|
|
|
<p class=P_SingleIndent>Enter Human Embryonic Stem Cells in each relevant component.</p>
|
|
|
|
|
|
|
|
<div class="heading4Indent">Research & Related Other Project Information (Service/Resource
|
|
Core)</div>
|
|
|
|
<p class=P_SingleIndent><strong>Human
|
|
Subjects:</strong> Answer only the Are Human Subjects Involved? and
|
|
'Is the Project Exempt from Federal regulations? questions.</p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent><strong>Vertebrate
|
|
Animals:</strong> Answer only the Are Vertebrate Animals Used?
|
|
question.</p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent><strong>Project
|
|
Narrative:</strong> Do not complete. Note: ASSIST screens will show an
|
|
asterisk for this attachment indicating it is required. However, eRA systems
|
|
only enforce this requirement in the Overall component and applications will
|
|
not receive an error if omitted in other components.</p>
|
|
|
|
|
|
|
|
<div class="heading4Indent">Project /Performance Site Location(s) (Service/Resource Core)</div>
|
|
|
|
<p class=P_SingleIndent>List all performance sites that apply to the specific
|
|
component.</p>
|
|
|
|
<p class=P_SingleIndent> </p>
|
|
|
|
<p class=P_SingleIndent>Note: The Project Performance Site form allows up to 300
|
|
sites, prior to using additional attachment for additional entries.</p>
|
|
|
|
<p class=P_SingleIndent> </p>
|
|
|
|
<div class="P_SingleIndent">Research & Related Senior/Key Person Profile (Service/Resource
|
|
Core)</div>
|
|
|
|
<p class=P_SingleIndent>
|
|
In the Project Director/Principal Investigator section of the
|
|
form, use Project Role of Other with Category of Core Lead and provide a
|
|
valid eRA Commons ID in the Credential field.</p>
|
|
|
|
<p class=P_SingleIndent>
|
|
In the additional Senior/Key Profiles section, list Senior/Key
|
|
persons that are working in the component.</p>
|
|
|
|
<p class=P_SingleIndent>
|
|
Include a single Biographical Sketch for each Senior/Key person
|
|
listed in the application regardless of the number of components in which they
|
|
participate. When a Senior/Key person is listed in multiple components, the
|
|
Biographical Sketch can be included in any one component.</p>
|
|
|
|
<p class=P_SingleIndent>
|
|
If more than 100 Senior/Key persons are included in a component,
|
|
the Additional Senior Key Person attachments should be used. </p>
|
|
|
|
<p class=P_SingleIndent> </p>
|
|
|
|
<div class="P_SingleIndent">Budget (Service/Resource Core)</div>
|
|
|
|
<p class=P_SingleIndent>Budget forms appropriate for the specific component will be
|
|
included in the application package.</p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent>Within the budget section, applicants should request funds
|
|
to support the following: </p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent>
|
|
Travel for the Service/Resource Core Leader (or their
|
|
representative) and other required Core personnel to participate in the Annual
|
|
Program Progress meeting (one 2-day meeting per year to be held in the
|
|
Rockville, MD area). Applicants may propose travel funds only for attendance at
|
|
program meetings related to this FOA.</p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent>Note: The R&R Budget form included in many of the
|
|
component types allows for up to 100 Senior/Key Persons in section A and 100
|
|
Equipment Items in section C prior to using attachments for additional entries.
|
|
All other SF424 (R&R) instructions apply.</p>
|
|
|
|
<p class=P_SingleIndent> </p>
|
|
|
|
<div class="P_SingleIndent">PHS 398 Research Plan (Service/Resource Core)</div>
|
|
|
|
<p class=P_SingleIndent> </p>
|
|
|
|
<p class=P_SingleIndent><strong>Specific
|
|
Aims:</strong> List
|
|
in priority order the proposed activities of the Service/Resource Core. Clearly
|
|
describe the relationship of the Core to the overall U19 goals and how the
|
|
proposed activities relate to the other research projects and cores in the
|
|
application. </p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent> <strong>Research
|
|
Strategy</strong>: </p>
|
|
|
|
<ul>
|
|
<li>
|
|
Describe the overall function of the Core and how this Core will
|
|
support and advance the outcomes from the research program.</li>
|
|
<li>
|
|
Discuss how the Core Leadership will support and facilitate the
|
|
functions provided by the Core. Describe and discuss the staffing plan
|
|
requirements to ensure specialized staffing needs are available that reflect
|
|
the core functions. Note that a Service/Resource Core must support at least
|
|
two research projects. </li>
|
|
<li>
|
|
Describe the processes, procedures, and methods associated with
|
|
the prioritization of the core functions. </li>
|
|
<li>
|
|
Explain the scientific rationale for selecting the methods,
|
|
technologies, and strategies to accomplish the aims of the Core.</li>
|
|
<li>
|
|
Describe any novel concepts, approaches, tools, or technologies
|
|
for the proposed studies, including their advantage over existing
|
|
methodologies.</li>
|
|
</ul>
|
|
|
|
<p class=P_SingleIndent><strong> Letters
|
|
of Support:</strong></p>
|
|
|
|
<ul>
|
|
<li>
|
|
Provide letters of support from the PDs/PIs of the clinical study
|
|
or clinical trial from which samples were obtained indicating access to the
|
|
samples has been granted and the timeframe for acquisition. </li>
|
|
<li>
|
|
Provide letters of support for access to unique assays, reagents
|
|
or technologies that may be required to perform the work conducted by the Core.
|
|
</li>
|
|
</ul>
|
|
|
|
<p class=P_SingleIndent><strong>Resource
|
|
Sharing Plan:</strong> Individuals are required to comply with the
|
|
instructions for the Resource Sharing Plans as provided in the SF424 (R&R)
|
|
Application Guide, with the following modification:</p>
|
|
|
|
|
|
|
|
<ul>
|
|
<li>
|
|
All applications, regardless of the amount of direct costs
|
|
requested for any one year, should address a Data Sharing Plan.</li>
|
|
<li>
|
|
Awardees will be expected to deposit data and data analyses into <a
|
|
href="https://www.immport.org/home">ImmPort</a> or other public data portal as
|
|
designated by NIAID. </li>
|
|
</ul>
|
|
|
|
<p class=P_SingleIndent><strong>Appendix:
|
|
</strong></p>
|
|
|
|
<p class=P_SingleIndent>Only limited items are allowed in the Appendix. Follow
|
|
all instructions for the Appendix as described in the SF424 (R&R)
|
|
Application Guide; any instructions provided here are in addition to the SF424
|
|
(R&R) Application Guide instructions. </p>
|
|
|
|
|
|
|
|
<div class="heading4Indent">PHS Human Subjects and Clinical Trials Information (Service/Resource
|
|
Core)</div>
|
|
|
|
<p class=P_SingleIndent>When involving human subjects research, clinical
|
|
research, and/or NIH-defined clinical trials follow all instructions for the
|
|
PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R)
|
|
Application Guide, with the following additional instructions:</p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent>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 a <strong>Delayed Onset Study</strong>
|
|
record.</p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent><strong>Study
|
|
Record: PHS Human Subjects and Clinical Trials Information</strong></p>
|
|
|
|
<p class=P_SingleIndent>All instructions in the SF424 (R&R) Application
|
|
Guide must be followed </p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent><strong>Delayed
|
|
Onset Study</strong></p>
|
|
|
|
<p class=P_SingleIndent>Note: <a
|
|
href="https://grants.nih.gov/grants/glossary.htm#DelayedOnsetHumanSubjectStudy">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 SF424 (R&R)
|
|
Application Guide must be followed </p>
|
|
|
|
|
|
|
|
<div class="heading4">Research Project</div>
|
|
|
|
<p class=regulartext>When preparing your application, use Component Type Project. </p>
|
|
|
|
|
|
|
|
<p class=regulartext>All instructions in the SF424 (R&R) Application Guide
|
|
must be followed, with the following additional instructions, as noted.</p>
|
|
|
|
|
|
|
|
<div class="heading4Indent">SF424 (R&R) Cover (Research Project)</div>
|
|
|
|
<p class=P_SingleIndent>Complete only the following fields:</p>
|
|
|
|
<ul>
|
|
<li>
|
|
Applicant Information</li>
|
|
<li>
|
|
Type of Applicant (optional)</li>
|
|
<li>
|
|
Descriptive Title of Applicant’s Project</li>
|
|
<li>
|
|
Proposed Project Start/Ending Dates</li>
|
|
</ul>
|
|
|
|
|
|
|
|
<div class="heading4Indent">PHS 398 Cover Page Supplement (Research Project)</div>
|
|
|
|
<p class=P_SingleIndent>Enter Human Embryonic Stem Cells in each relevant component.</p>
|
|
|
|
|
|
|
|
<div class="heading4Indent">Research & Related Other Project Information (Research
|
|
Project)</div>
|
|
|
|
<p class=P_SingleIndent><strong>Human
|
|
Subjects:</strong> Answer only the Are Human Subjects Involved? and
|
|
'Is the Project Exempt from Federal regulations? questions.</p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent><strong>Vertebrate
|
|
Animals:</strong> Answer only the Are Vertebrate Animals Used?
|
|
question.</p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent><strong>Project
|
|
Narrative:</strong> Do not complete. Note: ASSIST screens will show an
|
|
asterisk for this attachment indicating it is required. However, eRA systems
|
|
only enforce this requirement in the Overall component and applications will
|
|
not receive an error if omitted in other components.</p>
|
|
|
|
|
|
|
|
<div class="heading4Indent">Project /Performance Site Location(s) (Research Project)</div>
|
|
|
|
<p class=P_SingleIndent>List all performance sites that apply to the specific
|
|
component.</p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent>Note: The Project Performance Site form allows up to 300
|
|
sites, prior to using additional attachment for additional entries.</p>
|
|
|
|
|
|
|
|
<div class="heading4Indent">Research & Related Senior/Key Person Profile (Research
|
|
Project)</div>
|
|
|
|
<ul>
|
|
<li>
|
|
In the Project Director/Principal Investigator section of the
|
|
form, use Project Role of Other with Category of Project Lead and provide a
|
|
valid eRA Commons ID in the Credential field.</li>
|
|
<li>
|
|
In the additional Senior/Key Profiles section, list Senior/Key
|
|
persons that are working in the component.</li>
|
|
<li>
|
|
Include a single Biographical Sketch for each Senior/Key person
|
|
listed in the application regardless of the number of components in which they
|
|
participate. When a Senior/Key person is listed in multiple components, the
|
|
Biographical Sketch can be included in any one component.</li>
|
|
<li>
|
|
If more than 100 Senior/Key persons are included in a component,
|
|
the Additional Senior Key Person attachments should be used. </li>
|
|
</ul>
|
|
|
|
|
|
|
|
<div class="heading4Indent">Budget (Research Project)</div>
|
|
|
|
<p class=P_SingleIndent>Budget forms appropriate for the specific component will be
|
|
included in the application package. </p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent>Within the budget section, applicants should request funds
|
|
to support the following:</p>
|
|
|
|
|
|
|
|
<ul>
|
|
<li>
|
|
Travel funds for the Research Project Leader (or their
|
|
representative) and other required Project personnel to participate in the
|
|
Annual Program Progress meeting (one 2-day meeting per year to be held in the
|
|
Rockville, MD area). Applicants may propose travel funds only for attendance at
|
|
program meetings related to this FOA</li>
|
|
<li>
|
|
If applicable, request funds associated with acquiring biological
|
|
samples from independently funded, ongoing or completed clinical studies or
|
|
clinical trials: those costs might include for example, the costs of
|
|
re-consenting study participants, preparation of protocol amendments, and
|
|
additional sample collection, preparation, and shipping.</li>
|
|
</ul>
|
|
|
|
<p class=P_SingleIndent>Note: The R&R Budget form included in many of the
|
|
component types allows for up to 100 Senior/Key Persons in section A and 100
|
|
Equipment Items in section C prior to using attachments for additional entries.
|
|
All other SF424 (R&R) instructions apply.</p>
|
|
|
|
|
|
|
|
<div class="heading4Indent">PHS 398 Research Plan (Research Project)</div>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent><strong>Specific
|
|
Aims:</strong> <a
|
|
name="_Hlk49163316">List the broad long-range objectives and goals of the
|
|
proposed project</a>. Describe the hypothesis or hypotheses to be tested. In
|
|
addition, state the individual project's relationship to the overall U19 goals
|
|
and how it relates to other Projects or Cores. </p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent><strong>Research
|
|
Strategy: </strong></p>
|
|
|
|
<ul>
|
|
<li>
|
|
Describe how the proposed studies will utilize the appropriate
|
|
tools, methods, technologies and approaches (e.g., primary human immune cells,
|
|
tissues or fluids, and if needed, relevant animal models) to provide
|
|
mechanistic insights that will advance our understanding of immune development,
|
|
function or regulation over time applicable to adaptive, innate, and/or mucosal
|
|
immune responses to pathogen infection, vaccination, microbiome, allergens, and
|
|
environmental pollutants in children.</li>
|
|
<li>
|
|
Explain the rationale for selecting the tools, methods,
|
|
technologies, and approaches to accomplish the specific aims.</li>
|
|
<li>
|
|
Clearly describe the rationale and approach for selection of
|
|
cohort(s), the age range, sample sources and longitudinal assessments with
|
|
respect to the specific aims and the overall goals of the U19. </li>
|
|
<li>
|
|
Describe how the design of the study will address the requirement
|
|
to perform longitudinal assessments of the proposed unit of data collection.
|
|
Describe the proposed data and/or statistical analyses plans with respect to
|
|
the study design. </li>
|
|
<li>
|
|
If the research project uses samples from human subjects,
|
|
describe and justify how the samples are appropriate for the hypothesis to be
|
|
tested by the research project. Discuss the details of sample collection,
|
|
storage and nature of the assay with respect to the hypothesis to be tested.</li>
|
|
<li>
|
|
State the biological significance of the research. Explain how
|
|
the Research Project addresses the common immunological theme of the application
|
|
and how the project contributes to the overall goals of the project.</li>
|
|
<li>
|
|
If the research project uses an animal model, describe and
|
|
justify the species (relevance to the human clinical condition) and age (with
|
|
respect to the developmental time period of birth to less than 18 years of
|
|
human development) of the animal used. Describe the relevance of the chosen
|
|
animal model to the study of selected infections, vaccines, allergens, or
|
|
environmental pollutants in children from birth to less than 18 years of age.
|
|
Explain how the results from the animal model will guide mechanistic insights
|
|
into human immune development, function, or regulation and how they will extend
|
|
or complement the findings of proposed human studies. Note that animal studies
|
|
on HIV-related projects may only include non-human primates (NHP) as subjects.</li>
|
|
</ul>
|
|
|
|
<p class=P_SingleIndent><strong>Letters
|
|
of Support:</strong> Provide letters of support from collaborators that
|
|
are applicable to the Research Project, including a Memorandum of Understanding
|
|
(MOU) or Materials Transfer Agreement (MTA) that documents availability and/or
|
|
access to human materials for each source (i.e. sample availability and
|
|
timeline to acquire).</p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent><strong>Resource
|
|
Sharing Plan:</strong> Individuals are required to comply with the
|
|
instructions for the Resource Sharing Plans as provided in the SF424 (R&R)
|
|
Application Guide, with the following modification:</p>
|
|
|
|
|
|
|
|
<ul>
|
|
<li>
|
|
All applications, regardless of the amount of direct costs
|
|
requested for any one year, should address a Data Sharing Plan.</li>
|
|
<li>
|
|
Awardees will be expected to deposit data and data analyses into <a
|
|
href="https://www.immport.org/home">ImmPort</a> or other public data portal as
|
|
designated by NIAID. </li>
|
|
</ul>
|
|
|
|
<p class=P_SingleIndent><strong>Appendix:
|
|
</strong></p>
|
|
|
|
<p class=P_SingleIndent>Only limited items are allowed in the Appendix. Follow
|
|
all instructions for the Appendix as described in the SF424 (R&R)
|
|
Application Guide; any instructions provided here are in addition to the SF424
|
|
(R&R) Application Guide instructions. </p>
|
|
|
|
|
|
|
|
<div class="heading4Indent">PHS Human Subjects and Clinical Trials Information (Research
|
|
Project)</div>
|
|
|
|
<p class=P_SingleIndent>When involving human subjects research, clinical
|
|
research, and/or NIH-defined clinical trials follow all instructions for the
|
|
PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R)
|
|
Application Guide, with the following additional instructions:</p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent>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 a <strong>Delayed Onset Study</strong>
|
|
record.</p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent><strong>Study
|
|
Record: PHS Human Subjects and Clinical Trials Information</strong></p>
|
|
|
|
<p class=P_SingleIndent>All instructions in the SF424 (R&R) Application
|
|
Guide must be followed </p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent><strong>Delayed
|
|
Onset Study</strong></p>
|
|
|
|
<p class=P_SingleIndent>Note: <a
|
|
href="https://grants.nih.gov/grants/glossary.htm#DelayedOnsetHumanSubjectStudy">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 SF424 (R&R)
|
|
Application Guide must be followed </p>
|
|
|
|
|
|
|
|
<div class="heading3">3. Unique Entity Identifier
|
|
and System for Award Management (SAM)</div>
|
|
|
|
<p class=regulartext>See Part 1. Section III.1 for information regarding the
|
|
requirement for obtaining a unique entity identifier and for completing and
|
|
maintaining active registrations in System for Award Management (SAM), NATO
|
|
Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and
|
|
Grants.gov.</p>
|
|
|
|
|
|
|
|
<div class="heading3">4. Submission Dates and
|
|
Times</div>
|
|
|
|
<p class=regulartext><a href="#_Part_1._Overview">Part I. Overview Information</a>
|
|
contains information about Key Dates and times. Applicants are encouraged to
|
|
submit applications before the due date to ensure they have time to make any
|
|
application corrections that might be necessary for successful submission. When
|
|
a submission date falls on a weekend or <a
|
|
href="https://grants.nih.gov/grants/guide/url_redirect.htm?id=82380">Federal
|
|
holiday</a>, the application deadline is automatically extended to the next
|
|
business day.</p>
|
|
|
|
|
|
|
|
<p class=regulartext>Organizations must submit applications to <a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11128"
|
|
target="_blank">Grants.gov</a> (the online portal to find and apply for grants
|
|
across all Federal agencies) using ASSIST or other electronic submission
|
|
systems. Applicants must then complete the submission process by tracking the
|
|
status of the application in the <a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11123"
|
|
target="_blank">eRA Commons</a>, NIH’s electronic system for grants
|
|
administration. NIH and Grants.gov systems check the application against many
|
|
of the application instructions upon submission. Errors must be corrected and a
|
|
changed/corrected application must be submitted to Grants.gov on or before the
|
|
application due date and time. If a Changed/Corrected application is submitted
|
|
after the deadline, the application will be considered late. Applications that
|
|
miss the due date and time are subjected to the NIH Policy on Late Application
|
|
Submission. </p>
|
|
|
|
|
|
|
|
<p class=regulartext><strong>Applicants
|
|
are responsible for viewing their application before the due date in the eRA
|
|
Commons to ensure accurate and successful submission. </strong></p>
|
|
|
|
|
|
|
|
<p class=regulartext>Information on the submission process and a definition of
|
|
on-time submission are provided in the SF424 (R&R) Application Guide.</p>
|
|
|
|
|
|
|
|
<div class="heading3">5. Intergovernmental Review
|
|
(E.O. 12372)</div>
|
|
|
|
<p class=regulartext>This initiative is not subject to <a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11142">intergovernmental
|
|
review.</a> </p>
|
|
|
|
|
|
|
|
<div class="heading3"><a name="_5._Funding_Restrictions"></a>6. Funding Restrictions</div>
|
|
|
|
<p class=regulartext>All NIH awards are subject to the terms and conditions, cost
|
|
principles, and other considerations described in the <a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11120"><i>NIH
|
|
Grants Policy Statement</i></a>. </p>
|
|
|
|
|
|
|
|
<p class=regulartext>Pre-award costs are allowable only as described in the <a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11143"><i>NIH
|
|
Grants Policy Statement</i></a>.</p>
|
|
|
|
|
|
|
|
<div class="heading3">7. Other Submission
|
|
Requirements and Information</div>
|
|
|
|
<p class=regulartext>Applications must be submitted electronically following the
|
|
instructions described in the SF424 (R&R) Application Guide. Paper
|
|
applications will not be accepted. </p>
|
|
|
|
|
|
|
|
<p class=regulartext>For information on how your application will be
|
|
automatically assembled for review and funding consideration after submission
|
|
go to: <a
|
|
href="//grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf">http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf</a>. </p>
|
|
|
|
|
|
|
|
<p class=regulartext><b>Applicants must complete all required registrations
|
|
before the application due date.</b> <span class=P_SingleIndent><a href="#_Section_III._Eligibility">Section
|
|
III. Eligibility Information</a></span> contains information about registration.</p>
|
|
|
|
|
|
|
|
<p class=regulartext>For assistance with your electronic application or for more information on the electronic submission
|
|
process, visit <a
|
|
href="https://grants.nih.gov/grants/how-to-apply-application-guide.html">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 <a
|
|
href="#_Section_VII._Agency">Section VII</a>.</p>
|
|
|
|
|
|
|
|
<p class=regulartext><strong>Important reminders:</strong></p>
|
|
|
|
<p class=regulartext>All PD(s)/PI(s) and component
|
|
Project Leads must include their eRA Commons ID in the Credential field<b> </b>of
|
|
the Senior/Key Person Profile Component of the SF424(R&R) Application Package<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.</p>
|
|
|
|
|
|
|
|
<p class=regulartext>The applicant organization must
|
|
ensure that the DUNS number it provides on the application is the same number
|
|
used in the organization’s profile in the eRA Commons and for the System for
|
|
Award Management (SAM). Additional information may be found in the SF424
|
|
(R&R) Application Guide.</p>
|
|
|
|
|
|
|
|
<p class=regulartext>See <a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11146">more tips</a>
|
|
for avoiding common errors. </p>
|
|
|
|
|
|
|
|
<p class=regulartext>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>
|
|
|
|
|
|
|
|
<div class="heading4"><a name="_Toc258873270">Post Submission Materials</a></div>
|
|
|
|
<p class=regulartext>Applicants are required to follow the instructions for
|
|
post-submission materials, as described in <a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=82299">the policy</a>.
|
|
Any instructions
|
|
provided here are in addition to the instructions in the policy.</p>
|
|
|
|
|
|
|
|
<div class="heading2"><a name="_Section_V._Application"></a>Section V. Application Review Information</div>
|
|
|
|
<div class="heading3"><a name="_1._Criteria"></a>1.
|
|
Criteria</div>
|
|
|
|
<p class=regulartext>Only the review criteria described below will be considered
|
|
in the review process. Applications submitted to the NIH in support of the <a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11149">NIH mission</a>
|
|
are evaluated for scientific and technical merit through the NIH peer review
|
|
system.</p>
|
|
|
|
|
|
|
|
<div class="heading4">Overall Impact - Overall</div>
|
|
|
|
<p class=regulartext>Reviewers will provide an overall impact score to reflect
|
|
their assessment of the likelihood for the program 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
|
|
program proposed).</p>
|
|
|
|
|
|
|
|
<div class="heading4"><a name="scored_1"></a>Scored Review Criteria - Overall</div>
|
|
|
|
<p class=regulartext>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 program that by its nature is not
|
|
innovative may be essential to advance a field.</p>
|
|
|
|
|
|
|
|
<div class="heading4Indent">Significance</div>
|
|
|
|
<p class=P_SingleIndent>Does the program 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 program 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>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent><strong>Specific
|
|
to this FOA: </strong></p>
|
|
|
|
|
|
<ul>
|
|
<li>
|
|
If successful, will the outcomes from this research program help
|
|
drive the current and future research about immune system development from
|
|
birth through adolescence? </li>
|
|
</ul>
|
|
|
|
|
|
|
|
<div class="heading4Indent"><a name="scored_2"></a>Investigator(s)</div>
|
|
|
|
<p class=P_SingleIndent>Are the PD(s)/PI(s), collaborators,
|
|
and other researchers well suited to the program? 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>
|
|
|
|
|
|
|
|
<div class="heading4Indent"><a name="scored_3"></a>Innovation</div>
|
|
|
|
<p class=P_SingleIndent>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>
|
|
|
|
|
|
|
|
<div class="heading4Indent"><a name="scored_4"></a>Approach</div>
|
|
|
|
<p class=P_SingleIndent>Are the overall strategy,
|
|
methodology, and analyses well-reasoned and appropriate to accomplish the
|
|
specific aims of the program? Have 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>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent>If the program involves human
|
|
subjects and/or NIH-defined clinical research, are the plans to address:</p>
|
|
|
|
<p class=P_SingleIndent> 1) the protection of human
|
|
subjects from research risks, and </p>
|
|
|
|
<p class=P_SingleIndent> 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>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent><strong>Specific
|
|
to this FOA:</strong></p>
|
|
|
|
|
|
|
|
<ul>
|
|
<li>
|
|
To what extent does the integrated and collaborative approach
|
|
through the use of hypothesis-testing, mechanistic, and longitudinal studies of
|
|
the developing pediatric immune system sufficiently and comprehensively address
|
|
the goals of the proposed research program? </li>
|
|
<li>
|
|
Are the proposed hypotheses clearly directed at addressing
|
|
mechanisms of pediatric immune system development, regulation, and function?</li>
|
|
<li>
|
|
Are there coordination and synergy of the individual projects
|
|
towards the achievement of the central objectives of the research program? Will
|
|
the integration of the individual projects into a single research program be
|
|
more beneficial than pursuing each project independently? </li>
|
|
</ul>
|
|
|
|
<div class="heading4Indent"><a name="scored_5"></a>Environment</div>
|
|
|
|
<p class=P_SingleIndent>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>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent><strong>Overall Impact - Research Projects</strong></p>
|
|
|
|
<p class=P_SingleIndent>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>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent><strong>Scored Review Criteria - Research
|
|
Projects</strong></p>
|
|
|
|
<p class=P_SingleIndent>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>
|
|
|
|
|
|
|
|
<p class=heading4Indent>Significance</p>
|
|
|
|
<p class=P_SingleIndent>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>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent><strong>Specific
|
|
to this FOA: </strong></p>
|
|
|
|
|
|
|
|
<ul>
|
|
<li>
|
|
To what extent will the outcomes from the research projects lead
|
|
to new and potentially transformative discoveries in pediatric immune
|
|
development and responses to pathogens, commensal microbes, vaccines, allergens
|
|
or environmental pollutants? </li>
|
|
</ul>
|
|
|
|
|
|
|
|
<p class=heading4Indent>Investigator(s)</p>
|
|
|
|
<p class=P_SingleIndent>Are the Project Leads, 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-Lead, do the investigators have complementary and
|
|
integrated expertise; are their leadership approach, governance and
|
|
organizational structure appropriate for the project?</p>
|
|
|
|
|
|
|
|
<p class=heading4Indent>Innovation</p>
|
|
|
|
<p class=P_SingleIndent>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>
|
|
|
|
|
|
|
|
<p class=heading4Indent>Approach</p>
|
|
|
|
<p class=P_SingleIndent>Are the overall strategy, methodology, and analyses well-reasoned
|
|
and appropriate to accomplish the specific aims of the project? Have
|
|
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>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent>If the project involves human subjects and/or
|
|
NIH-defined clinical research, are the plans to address:</p>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent>1) the protection of human subjects from research
|
|
risks, and </p>
|
|
|
|
<p class=P_SingleIndent>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>
|
|
|
|
|
|
|
|
<p class=P_SingleIndent><strong>Specific
|
|
for this FOA:</strong></p>
|
|
|
|
|
|
|
|
<ul>
|
|
<li>
|
|
Will the longitudinal assessments proposed address the major
|
|
theme of immune system development from birth through adolescence? Is
|
|
justification provided for the human cohort(s) selected and the longitudinal
|
|
assessment(s) proposed for the study?</li>
|
|
<li>
|
|
For studies using human subjects/clinical samples, are the
|
|
timeline for protocol development and implementation, plans for recruitment and
|
|
retention of study participants, proposed study site(s), safety monitoring and
|
|
plans for management and analysis of study data appropriate and feasible?</li>
|
|
<li>
|
|
For studies proposing the use of animal models, if applicable, are
|
|
the relevance of the proposed animal models to human diseases and the timing of
|
|
immune development and function to the developmental age under study
|
|
well-justified? Is there strong scientific potential for findings in animals to
|
|
reflect or recapitulate human immune function?</li>
|
|
<li>
|
|
In studies using human biospecimens collected from independently
|
|
funded clinical research or clinical trials, are the timeline and documentation
|
|
adequate and feasible to successfully obtain the samples and implement the
|
|
proposed project(s)?</li>
|
|
<li>
|
|
For studies involving human subjects, clinical samples or animal
|
|
models, are the data and/or statistical analyses plans acceptable?</li>
|
|
</ul>
|
|
|
|
<p class=heading4Indent>Environment</p>
|
|
|
|
<p class=P_SingleIndent>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>
|
|
|
|
<p class=P_SingleIndent> </p>
|
|
|
|
|
|
|
|
<div class="heading4">Overall Impact - Administrative, Service/Resource
|
|
(optional), Data Management and Analysis Cores</div>
|
|
|
|
<p class=regulartext>Reviewers will provide an overall impact score to reflect
|
|
their assessment of the likelihood for the core to exert a sustained, powerful
|
|
influence on the research field(s) involved, in consideration of the following
|
|
review criteria.</p>
|
|
|
|
|
|
|
|
<div class="heading4">Review Criteria - Administrative,
|
|
Service/Resource (optional), Data Management and Analysis Cores </div>
|
|
|
|
<p class=regulartext>Reviewers will consider each of the review criteria below,
|
|
as appropriate for the individual core, in the determination of scientific
|
|
merit and provide an overall impact score for each Core but will not give
|
|
separate scores for these items.</p>
|
|
|
|
|
|
|
|
<div class="heading4Indent">Administrative Core</div>
|
|
|
|
<ul>
|
|
<li>
|
|
Is the proposed organizational and administrative structure of
|
|
the application sufficient to implement the proposed research through
|
|
completion? Does the staffing plan address specific opportunities for
|
|
coordination, administration and collaboration among leaders and staff? </li>
|
|
<li>
|
|
Is the plan for exchanging information among the project and core
|
|
leaders adequate to achieve a thorough understanding of the day to day
|
|
functioning of the U19, including identifying barriers to progress?</li>
|
|
<li>
|
|
Are the plans for coordination, problem identification and resolution,
|
|
and establishment of a strong collaborative environment for the project
|
|
appropriate?</li>
|
|
<li>
|
|
Are the plans for resource allocation within the project adequate
|
|
and appropriate?</li>
|
|
<li>
|
|
Is the management plan for fiscal accountability and
|
|
communication within the project appropriate?</li>
|
|
<li>
|
|
Is the Project Management Plan (PMP) sufficiently detailed to
|
|
ensure compliance with the timelines and milestones for the project, and to
|
|
achieve the stated goals and objectives of the U19? Is the plan for monitoring
|
|
and updating the PMP clearly articulated? </li>
|
|
</ul>
|
|
|
|
<div class="heading4Indent">Data Management and Analysis Core</div>
|
|
|
|
<ul>
|
|
<li>
|
|
How well does the staffing plan address the unique needs for
|
|
specialized staffing to achieve all the necessary functions of the core
|
|
(including data transfer to <a href="https://www.immport.org/home" Title="Link to Non-U.S. Government Site">ImmPort</a>
|
|
of other public portals designated by NIAID), and the extent to which the
|
|
leadership of the core is appropriate to the outcomes? </li>
|
|
<li>
|
|
Is there sufficient bioinformatics infrastructure to support the
|
|
proposed activities?</li>
|
|
<li>
|
|
If support is proposed for study design, statistical analyses and
|
|
computational modeling (if applicable), are sufficient effort and expertise
|
|
included in the core?</li>
|
|
<li>
|
|
Are the data and/or statistical analyses plans meaningful,
|
|
adequate and appropriate for the hypotheses proposed, including proposed power
|
|
calculations and data analysis for the use of data derived from human clinical
|
|
samples?</li>
|
|
</ul>
|
|
|
|
<div class="heading4"> </div>
|
|
|
|
<div class="heading4Indent">Service/Resource Core (optional)</div>
|
|
|
|
<ul>
|
|
<li>
|
|
Does the Core provide support to two or more Research Projects?</li>
|
|
<li>
|
|
Is there a clear relationship of the Core to the central
|
|
scientific theme of the overall project?</li>
|
|
<li>
|
|
Is the process for prioritization of Core functions appropriate
|
|
and justified?</li>
|
|
<li>
|
|
Does the staffing plan address the specific and unique needs of
|
|
the service/resource core? </li>
|
|
<li>
|
|
If a Clinical Core is included, does the leader have the
|
|
experience and capabilities to guide and support the clinical research
|
|
activities proposed in the application?</li>
|
|
</ul>
|
|
|
|
<div class="heading4">Additional Review Criteria - Overall, Research Projects,
|
|
and Cores </div>
|
|
|
|
<p class=regulartext>As applicable for the program 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 class="heading4Indent"><a name=humans></a>Protections
|
|
for Human Subjects</div>
|
|
|
|
<p class=P_SingleIndent>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 class=P_SingleIndent>For research that involves human
|
|
subjects and meets the criteria for one or more of the categories of research
|
|
that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the
|
|
justification for the exemption, 2) human subjects involvement and
|
|
characteristics, and 3) sources of materials. For additional information on
|
|
review of the Human Subjects section, please refer to the <a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11175">Guidelines
|
|
for the Review of Human Subjects</a>.</p>
|
|
|
|
|
|
|
|
<div class="heading4Indent"><a name=inclusion></a>Inclusion
|
|
of Women, Minorities, and Individuals Across the Lifespan </div>
|
|
|
|
<p class=P_SingleIndent>When the proposed program 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.htm?id=11174">Guidelines
|
|
for the Review of Inclusion in Clinical Research</a>.</p>
|
|
|
|
|
|
|
|
<div class="heading4Indent"><a name=animals></a>Vertebrate
|
|
Animals</div>
|
|
|
|
<p class=P_SingleIndent>The committee will evaluate the
|
|
involvement of live vertebrate animals as part of the scientific assessment
|
|
according to the following criteria: (1) description of proposed procedures
|
|
involving animals, including species, strains, ages, sex, and total number to
|
|
be used; (2) justifications for the use of animals versus alternative models
|
|
and for the appropriateness of the species proposed; (3) interventions to
|
|
minimize discomfort, distress, pain and injury; and (4) justification for
|
|
euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia
|
|
of Animals. Reviewers will assess the use of chimpanzees as they would any other
|
|
application proposing the use of vertebrate animals. For additional information
|
|
on review of the Vertebrate Animals section, please refer to the <a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11150">Worksheet
|
|
for Review of the Vertebrate Animal Section</a>.</p>
|
|
|
|
|
|
|
|
<div class="heading4Indent"><a name=biohazards></a>Biohazards</div>
|
|
|
|
<p class=P_SingleIndent>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>
|
|
|
|
|
|
|
|
<div class="heading4Indent"><a name=resubmissions></a>Resubmissions</div>
|
|
|
|
<p class=P_SingleIndent>Not Applicable </p>
|
|
|
|
|
|
|
|
<div class="heading4Indent"><a name=renewals></a>Renewals</div>
|
|
|
|
<p class=P_SingleIndent>Not Applicable</p>
|
|
|
|
|
|
|
|
<div class="Heading4Char"><a name=revisions></a>Revisions</div>
|
|
|
|
<p class=P_SingleIndent>Not Applicable</p>
|
|
|
|
|
|
|
|
<div class="heading4">Additional Review Considerations - Overall, Research
|
|
Projects, and Cores </div>
|
|
|
|
<p class=regulartext>As applicable for the program 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 class="heading4Indent"><a name=foreign></a>Applications
|
|
from Foreign Organizations</div>
|
|
|
|
<p class=P_SingleIndent>Not Applicable </p>
|
|
|
|
|
|
|
|
<div class="heading4Indent"><a name=agents></a>Select Agent
|
|
Research</div>
|
|
|
|
<p class=P_SingleIndent>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>
|
|
|
|
|
|
|
|
<div class="heading4Indent"><a name=sharing></a>Resource
|
|
Sharing Plans</div>
|
|
|
|
<p class=P_SingleIndent>Reviewers will comment on whether
|
|
the following Resource Sharing Plans, or the rationale for not sharing the
|
|
following types of resources, are reasonable: 1) <a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11151">Data
|
|
Sharing Plan</a>; 2) <a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11152">Sharing
|
|
Model Organisms</a>; and 3) <a
|
|
href="//grants.nih.gov/grants/guide/notice-files/NOT-OD-14-124.html">Genomic
|
|
Data Sharing Plan</a> .</p>
|
|
|
|
<div class="heading4Indent"><br>
|
|
<a name=authentication></a>Authentication of Key Biological
|
|
and/or Chemical Resources</div>
|
|
|
|
<p class=P_SingleIndent>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>
|
|
|
|
|
|
|
|
<div class="heading4Indent"><a name=budget></a>Budget and
|
|
Period of Support</div>
|
|
|
|
<p class=P_SingleIndent>Reviewers will consider whether the
|
|
budget and the requested period of support are fully justified and reasonable
|
|
in relation to the proposed research.</p>
|
|
|
|
|
|
|
|
<div class="heading3">2. Review and Selection
|
|
Process </div>
|
|
|
|
<p class=regulartext>Applications will be evaluated for scientific and technical
|
|
merit by (an) appropriate Scientific Review Group(s), convened by National
|
|
Institute of Allergy and Infectious Diseases (NIAID) in accordance with <a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11154">NIH peer
|
|
review policy and procedures</a>, using the stated <a href="#_1._Criteria">review
|
|
criteria</a>. Assignment to a Scientific Review Group will be shown in the eRA
|
|
Commons. </p>
|
|
|
|
|
|
|
|
<p class=regulartext>As part of the scientific peer review, all applications:</p>
|
|
|
|
<ul>
|
|
<li>
|
|
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. </li>
|
|
<li>
|
|
Will receive a written critique.</li>
|
|
</ul>
|
|
|
|
<p class=regulartext><a
|
|
href="//grants.nih.gov/grants/guide/notice-files/NOT-OD-11-064.html">Appeals</a>
|
|
of initial peer review will not be accepted for applications submitted in
|
|
response to this FOA.</p>
|
|
|
|
|
|
|
|
<p class=regulartext>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 FOA. Following initial peer review, recommended applications
|
|
will receive a second level of review by the appropriate national Advisory
|
|
Council or Board. 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 class="heading3"><a name="_3._Anticipated_Announcement"></a>3. Anticipated Announcement and Award Dates</div>
|
|
|
|
<p class=regulartext>After the peer review of the application is completed, the
|
|
PD/PI will be able to access his or her Summary Statement (written critique)
|
|
via the <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11123">eRA
|
|
Commons</a>. Refer to Part 1 for dates for peer review, advisory council
|
|
review, and earliest start date.</p>
|
|
|
|
|
|
|
|
<p class=regulartext>Information regarding the disposition of applications is
|
|
available in the <a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11156"><i>NIH
|
|
Grants Policy Statement</i></a>. </p>
|
|
|
|
|
|
|
|
<div class="heading2"><a name="_Toc258873271"></a><a
|
|
name="_Section_VI._Award"></a>Section VI. Award
|
|
Administration Information</div>
|
|
|
|
<div class="heading3">1. Award Notices</div>
|
|
|
|
<p class=regulartext>If the application is under consideration for funding, NIH
|
|
will request "just-in-time" information from the applicant as
|
|
described in the <a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11157"><i>NIH
|
|
Grants Policy Statement</i></a>. </p>
|
|
|
|
|
|
|
|
<p class=regulartext>A formal notification in the form of a Notice of Award (NoA)
|
|
will be provided to the applicant organization for successful applications. The
|
|
NoA signed by the grants management officer is the authorizing document and
|
|
will be sent via email to the grantee’s business official. </p>
|
|
|
|
|
|
|
|
<p class=regulartext>Awardees must comply with any funding restrictions described
|
|
in <a href="#_5._Funding_Restrictions">Section IV.5. Funding Restrictions</a>. Selection
|
|
of an application for award is not an authorization to begin performance. Any
|
|
costs incurred before receipt of the NoA are at the recipient's risk. These
|
|
costs may be reimbursed only to the extent considered allowable pre-award costs.</p>
|
|
|
|
<p class=regulartext>Any application awarded in response to this FOA will be
|
|
subject to terms and conditions found on the <a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11158">Award
|
|
Conditions and Information for NIH Grants</a> website. This includes any
|
|
recent legislation and policy applicable to awards that is highlighted on this
|
|
website.</p>
|
|
|
|
|
|
|
|
<p class=regulartext>Institutional Review Board or Independent Ethics Committee
|
|
Approval: Grantee 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 awardee must provide NIH copies of documents related to all major
|
|
changes in the status of ongoing protocols.</p>
|
|
|
|
|
|
|
|
<div class="heading3">2. Administrative and
|
|
National Policy Requirements</div>
|
|
|
|
<p class=regulartext>All NIH grant and cooperative agreement awards include the <a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11120"><i>NIH
|
|
Grants Policy Statement</i></a> as part of the NoA. For these terms of award,
|
|
see the <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11157"><i>NIH
|
|
Grants Policy Statement</i> Part II: Terms and Conditions of NIH Grant Awards,
|
|
Subpart A: General</a> and <a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11159">Part II:
|
|
Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for
|
|
Specific Types of Grants, Grantees, and Activities</a>. More information is
|
|
provided at <a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11158">Award
|
|
Conditions and Information for NIH Grants</a>.</p>
|
|
|
|
|
|
|
|
<p class=regulartext>Recipients of federal financial assistance (FFA) from HHS
|
|
must administer their programs in compliance with federal civil rights laws
|
|
that prohibit discrimination on the basis of race, color, national origin,
|
|
disability, age and, in some circumstances, religion, conscience, and
|
|
sex. This includes ensuring programs are accessible to persons with
|
|
limited English proficiency. The HHS Office for Civil Rights provides guidance
|
|
on complying with civil rights laws enforced by HHS. Please see <a
|
|
href="https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html">https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html</a>
|
|
and <a href="https://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html">http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html</a>.</p>
|
|
|
|
|
|
|
|
<p class=regulartext>HHS recognizes that research projects are often limited in
|
|
scope for many reasons that are nondiscriminatory, such as the principal
|
|
investigator’s scientific interest, funding limitations, recruitment
|
|
requirements, and other considerations. Thus, criteria in research protocols
|
|
that target or exclude certain populations are warranted where
|
|
nondiscriminatory justifications establish that such criteria are appropriate
|
|
with respect to the health or safety of the subjects, the scientific study
|
|
design, or the purpose of the research. For additional guidance regarding how
|
|
the provisions apply to NIH grant programs, please contact the
|
|
Scientific/Research Contact that is identified in Section VII under Agency
|
|
Contacts of this FOA.</p>
|
|
|
|
|
|
|
|
<ul>
|
|
<li>
|
|
Recipients of FFA must ensure that their programs are accessible
|
|
to persons with limited English proficiency. HHS provides guidance to
|
|
recipients of FFA on meeting their legal obligation to take reasonable steps to
|
|
provide meaningful access to their programs by persons with limited English
|
|
proficiency. Please see <a
|
|
href="https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html">https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html</a>
|
|
and <a href="https://www.lep.gov">https://www.lep.gov</a>. For further guidance on providing
|
|
culturally and linguistically appropriate services, recipients should review
|
|
the National Standards for Culturally and Linguistically Appropriate Services
|
|
in Health and Health Care at <a
|
|
href="https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53">https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53</a>.
|
|
</li>
|
|
<li>
|
|
Recipients of FFA also have specific legal obligations for
|
|
serving qualified individuals with disabilities. Please see <a href="https://www.hhs.gov/ocr/civilrights/understanding/disability/index.html">http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html</a>.</li>
|
|
|
|
<li>
|
|
HHS funded health and education programs must be administered in
|
|
an environment free of sexual harassment. Please see <a
|
|
href="https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html">https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html</a>;
|
|
https://www2.ed.gov/about/offices/list/ocr/docs/shguide.html; and <a
|
|
href="https://www.eeoc.gov/eeoc/publications/upload/fs-sex.pdf">https://www.eeoc.gov/eeoc/publications/upload/fs-sex.pdf</a>.
|
|
For information about NIH's commitment to supporting a safe and respectful work
|
|
environment, who to contact with questions or concerns, and what NIH's
|
|
expectations are for institutions and the individuals supported on NIH-funded
|
|
awards, please see <a href="https://grants.nih.gov/grants/policy/harassment.htm">https://grants.nih.gov/grants/policy/harassment.htm</a>.
|
|
</li>
|
|
|
|
<li>
|
|
Recipients of FFA must also administer their programs in
|
|
compliance with applicable federal religious nondiscrimination laws and
|
|
applicable federal conscience protection and associated anti-discrimination
|
|
laws. Collectively, these laws prohibit exclusion, adverse treatment,
|
|
coercion, or other discrimination against persons or entities on the basis of
|
|
their consciences, religious beliefs, or moral convictions. Please see <a
|
|
href="https://www.hhs.gov/conscience/conscience-protections/index.html">https://www.hhs.gov/conscience/conscience-protections/index.html</a>
|
|
and <a href="https://www.hhs.gov/conscience/religious-freedom/index.html">https://www.hhs.gov/conscience/religious-freedom/index.html</a>.
|
|
</li>
|
|
</ul>
|
|
|
|
|
|
|
|
<p class=regulartext>Please contact the HHS Office for Civil Rights for more
|
|
information about obligations and prohibitions under federal civil rights laws
|
|
at <a href="https://www.hhs.gov/ocr/about-us/contact-us/index.html">https://www.hhs.gov/ocr/about-us/contact-us/index.html</a>
|
|
or call 1-800-368-1019 or TDD 1-800-537-7697. </p>
|
|
|
|
|
|
|
|
<p class=regulartext>In accordance with the statutory provisions contained in
|
|
Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal
|
|
Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal
|
|
Awardee Performance and Integrity Information System (FAPIIS) requirements.
|
|
FAPIIS requires Federal award making officials to review and consider
|
|
information about an applicant in the designated integrity and performance
|
|
system (currently FAPIIS) prior to making an award. An applicant, at its
|
|
option, may review information in the designated integrity and performance
|
|
systems accessible through FAPIIS and comment on any information about itself
|
|
that a Federal agency previously entered and is currently in FAPIIS. The
|
|
Federal awarding agency will consider any comments by the applicant, in
|
|
addition to other information in FAPIIS, in making a judgement about the
|
|
applicant’s integrity, business ethics, and record of performance under Federal
|
|
awards when completing the review of risk posed by applicants as described in
|
|
45 CFR Part 75.205 Federal awarding agency review of risk posed by
|
|
applicants. This provision will apply to all NIH grants and cooperative
|
|
agreements except fellowships.</p>
|
|
|
|
|
|
|
|
<p class=heading4>Cooperative Agreement Terms and Conditions of Award</p>
|
|
|
|
<p class=regulartext>The following special terms of award are in addition to, and
|
|
not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB)
|
|
administrative guidelines, U.S. Department of Health and Human Services (DHHS)
|
|
grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and NIH
|
|
grant administration policies. <br>
|
|
<br>
|
|
The administrative and funding instrument used for this program will be the
|
|
cooperative agreement, an "assistance" mechanism (rather than an
|
|
"acquisition" mechanism), in which substantial NIH programmatic
|
|
involvement with the awardees is anticipated during the performance of the
|
|
activities. Under the cooperative agreement, the NIH purpose is to support and
|
|
stimulate the recipients' activities by involvement in and otherwise working
|
|
jointly with the award recipients in a partnership role; it is not to assume
|
|
direction, prime responsibility, or a dominant role in the activities.
|
|
Consistent with this concept, the dominant role and prime responsibility
|
|
resides with the awardees for the project as a whole, although specific tasks
|
|
and activities may be shared among the awardees and the NIH as defined below.
|
|
</p>
|
|
|
|
<p class=regulartext><strong>The
|
|
PD(s)/PI(s) will have the primary responsibility for</strong>:</p>
|
|
|
|
<ul>
|
|
<li>
|
|
Serving as the lead for scientific and administrative oversight
|
|
for the proposed research, including overseeing, managing, and coordinating the
|
|
overall Program.</li>
|
|
<li>
|
|
Providing oversight and coordination for the successful
|
|
completion of the data- and other resource-sharing plans negotiated with
|
|
NIAID. </li>
|
|
<li>
|
|
Ensuring adherence to the timelines and milestones within the
|
|
Project Management Plan</li>
|
|
<li>
|
|
Serve as voting member of the Steering Committee</li>
|
|
<li>
|
|
Sharing reagents and resources with other investigators funded
|
|
under this FOA as appropriate and consistent with achieving the goals of the
|
|
program.</li>
|
|
<li>
|
|
Awardees will retain custody of and have primary rights to the
|
|
data and software developed under these awards, subject to Government rights of
|
|
access consistent with current DHHS, PHS, and NIH policies. </li>
|
|
</ul>
|
|
|
|
<p class=regulartext><strong>NIH
|
|
staff (Project Scientist) have substantial programmatic involvement that is above
|
|
and beyond the normal stewardship role in awards, as described below</strong>:
|
|
</p>
|
|
|
|
<ul>
|
|
<li>
|
|
Providing input into the design of research activities and
|
|
oversight of technical performance. </li>
|
|
<li>
|
|
Coordinating NIH staff assistance with regard to: </li>
|
|
<li class="P_DoubleIndent">
|
|
Oversight and monitoring of collaborative research </li>
|
|
<li class="P_DoubleIndent">
|
|
Feasibility of timely progress towards completion of planned
|
|
activities</li>
|
|
<li class="P_DoubleIndent">
|
|
Facilitating collaborations with, and access to, other
|
|
NIH-supported research resources and services</li>
|
|
<li class="P_DoubleIndent">
|
|
Facilitating collaborations within and outside of NIH</li>
|
|
<li class="P_DoubleIndent">
|
|
Facilitating compliance with data-sharing and other
|
|
resource-sharing plans </li>
|
|
<li class="P_DoubleIndent">
|
|
Plans for incorporation of new technologies or other resources</li>
|
|
<li class="P_DoubleIndent">
|
|
Periodic on-site monitoring with respect to compliance with
|
|
Federal regulations associated with scientific need, such as quality control,
|
|
accuracy of data recording, sample accrual, etc. </li>
|
|
<li>
|
|
Providing advice and input on modifications to data- and
|
|
resource- sharing plans to ensure completion</li>
|
|
<li>
|
|
Serving as a liaison/facilitator among awardees and with the
|
|
NIAID <a href="https://www.immport.org/home" Title="Link to Non-U.S. Government Site">ImmPort</a> database and other web
|
|
portals.</li>
|
|
<li>
|
|
Periodically reviewing data and access confidential data
|
|
generated under the award for use in the preparation of internal reports on the
|
|
activities of the awardees.</li>
|
|
<li>
|
|
Serve as a resource for scientific and policy information related
|
|
to the goals of the awardees' research.</li>
|
|
<li>
|
|
Serve as non-voting member of Steering Committee.</li>
|
|
<li>
|
|
Appoint subject matter experts as non-voting members on Steering
|
|
Committee. </li>
|
|
<li>
|
|
Additionally, an agency program official or IC program director
|
|
will be responsible for the normal scientific and programmatic stewardship of
|
|
the award and will be named in the award notice. </li>
|
|
</ul>
|
|
|
|
<p class=regulartext><strong>Areas
|
|
of Joint Responsibility include</strong>:</p>
|
|
|
|
<ul>
|
|
<li>
|
|
Establish an External Scientific Group (ESG) </li>
|
|
<li>
|
|
Establish a Steering Committee consisting of awardees and NIH
|
|
Project Scientists from funding ICs.</li>
|
|
<li><strong class="Bullet">
|
|
</strong>Review progress and foster collaborations</li>
|
|
</ul>
|
|
|
|
<p class=regulartext><strong>Dispute
|
|
Resolution</strong>:</p>
|
|
|
|
<p class=regulartext>Any disagreements that may arise in scientific or
|
|
programmatic matters (within the scope of the award) between award recipients
|
|
and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel
|
|
composed of three members will be convened. It will have three members: a
|
|
designee of the Steering Committee chosen without NIH staff voting, one NIH
|
|
designee, and a third designee with expertise in the relevant area who is
|
|
chosen by the other two; in the case of individual disagreement, the first
|
|
member may be chosen by the individual awardee. This special dispute resolution
|
|
procedure does not alter the awardee's right to appeal an adverse action that
|
|
is otherwise appealable in accordance with PHS regulation 42 CFR Part 50,
|
|
Subpart D and DHHS regulation 45 CFR Part 16.</p>
|
|
|
|
|
|
|
|
<div class="heading3">3. Reporting</div>
|
|
|
|
<p class=regulartext>When multiple years are involved, awardees will be required
|
|
to submit the <a href="//grants.nih.gov/grants/rppr/index.htm">Research Performance Progress Report
|
|
(RPPR)</a> annually and financial statements as required in the <a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11161"><i>NIH
|
|
Grants Policy Statement</i>.</a> </p>
|
|
|
|
|
|
|
|
<p class=regulartext><a name=SectionVII></a>A final RPPR, invention statement, and the expenditure data portion of the
|
|
Federal Financial Report are required for closeout of an award, as described in
|
|
the <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11161"><i>NIH
|
|
Grants Policy Statement</i></a>.</p>
|
|
|
|
|
|
|
|
<p class=regulartext>The Federal Funding Accountability and Transparency Act of
|
|
2006 (Transparency Act), includes a requirement for awardees of Federal grants
|
|
to report information about first-tier subawards and executive compensation
|
|
under Federal assistance awards issued in FY2011 or later. All awardees of
|
|
applicable NIH grants and cooperative agreements are required to report to
|
|
the Federal Subaward Reporting System (FSRS) available at <a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11170">www.fsrs.gov</a>
|
|
on all subawards over $25,000. See the <a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11171"><i>NIH
|
|
Grants Policy Statement</i></a> for additional information on this reporting
|
|
requirement. </p>
|
|
|
|
|
|
|
|
<p class=regulartext>In accordance with the regulatory requirements provided at
|
|
45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have
|
|
currently active Federal grants, cooperative agreements, and procurement
|
|
contracts from all Federal awarding agencies with a cumulative total value
|
|
greater than $10,000,000 for any period of time during the period of
|
|
performance of a Federal award, must report and maintain the currency of
|
|
information reported in the System for Award Management (SAM) about civil,
|
|
criminal, and administrative proceedings in connection with the award or
|
|
performance of a Federal award that reached final disposition within the most
|
|
recent five-year period. The recipient must also make semiannual
|
|
disclosures regarding such proceedings. Proceedings information will be
|
|
made publicly available in the designated integrity and performance system
|
|
(currently FAPIIS). This is a statutory requirement under section 872 of
|
|
Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010
|
|
of Public Law 111-212, all information posted in the designated integrity and
|
|
performance system on or after April 15, 2011, except past performance reviews
|
|
required for Federal procurement contracts, will be publicly available. Full
|
|
reporting requirements and procedures are found in Appendix XII to 45 CFR Part
|
|
75 Award Term and Conditions for Recipient Integrity and Performance Matters.</p>
|
|
|
|
|
|
|
|
<div class="heading2"><a name="_Toc258873272"></a><a
|
|
name="_Section_VII._Agency"></a>Section VII. Agency Contacts</div>
|
|
|
|
<p class=regulartext>We encourage inquiries concerning this funding opportunity
|
|
and welcome the opportunity to answer questions from potential applicants. <br>
|
|
<br>
|
|
</p>
|
|
|
|
<div class="heading4">Application Submission Contacts</div>
|
|
|
|
<p class=regulartext>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=regulartext>Finding Help Online: http://grants.nih.gov/support/ (preferred
|
|
method of contact)<br>
|
|
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)</p>
|
|
|
|
|
|
|
|
<p class=regulartext>General Grants Information
|
|
(Questions regarding application instructions, application processes, and NIH
|
|
grant resources)<br>
|
|
Email: <a href="/cdn-cgi/l/email-protection#5d1a2f3c33292e14333b321d333435733a322b"><span class="__cf_email__" data-cfemail="82c5f0e3ecf6f1cbece4edc2ecebeaace5edf4">[email protected]</span></a> (preferred
|
|
method of contact)<br>
|
|
Telephone: 301-945-7573</p>
|
|
|
|
|
|
|
|
<p class=regulartext>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#5a292f2a2a35282e1a3d283b342e29743d352c"><span class="__cf_email__" data-cfemail="25565055554a5751654257444b51560b424a53">[email protected]</span></a><br>
|
|
<br>
|
|
</p>
|
|
|
|
<div class="heading4">Scientific/Research Contact(s)</div>
|
|
|
|
<p class=regulartext>Mercy Prabhudas, Ph.D., M.B.A.<br>Division of Allergy, Immunology and Transplantation<br>National Institute of Allergy and Infectious Diseases
|
|
(NIAID)<br>
|
|
Telephone: 240-627-3534 <br>
|
|
Email: <a href="/cdn-cgi/l/email-protection#adc0dddfcccfc5d8c9ccdeedc3c4ccc4c983c3c4c583cac2db"><span class="__cf_email__" data-cfemail="89e4f9fbe8ebe1fcede8fac9e7e0e8e0eda7e7e0e1a7eee6ff">[email protected]</span></a> </p>
|
|
|
|
|
|
|
|
<p class=regulartext>Que Dang, Ph.D.<br>Division of AIDS<br>National Institute of Allergy and Infectious Diseases
|
|
(NIAID)<br>Telephone: 240-292-6181 <br>
|
|
Email: <a href="/cdn-cgi/l/email-protection#e1909484cf85808f86a18f8889cf868e97"><span class="__cf_email__" data-cfemail="0d7c786823696c636a4d636465236a627b">[email protected]</span></a></p>
|
|
|
|
|
|
|
|
<p class=regulartext>Anjali Singh, Ph.D.<br>National Institute of Allergy and Infectious Diseases
|
|
(NIAID)<br>Division of AIDS<br>Telephone: 240-627-3030<br>Email: <a href="/cdn-cgi/l/email-protection#74151a1e15181d071d1a131c341a1d151d105a1a1d1c5a131b02" title="mailto:anjalisingh@niaid.nih.gov"><span class="__cf_email__" data-cfemail="fe9f90949f92978d97909996be90979f979ad0909796d0999188">[email protected]</span></a></p>
|
|
|
|
|
|
|
|
<p class=regulartext>Michael C. Humble, Ph.D.<br>National Institute of Environmental Health Sciences (NIEHS)<br>Telephone: 984-287-3272<br>Email: <a href="/cdn-cgi/l/email-protection#4129342c232d24012f282429326f2f28296f262e37"><span class="__cf_email__" data-cfemail="b3dbc6ded1dfd6f3dddad6dbc09ddddadb9dd4dcc5">[email protected]</span></a>
|
|
</p>
|
|
|
|
|
|
|
|
<div class="heading4">Peer Review Contact(s)</div>
|
|
|
|
<p class=regulartext>Maggie Morris Fears, Ph.D.<br>National Institute of Allergy and Infectious Diseases
|
|
(NIAID)<br>Telephone: 301-761-5444<br>Email: <a href="/cdn-cgi/l/email-protection#92fff3f5f5fbf7bcfffde0e0fbe1f4f7f3e0e1d2fcfbfabcf5fde4"><span class="__cf_email__" data-cfemail="0e636f6969676b2063617c7c677d686b6f7c7d4e60676620696178">[email protected]</span></a></p>
|
|
|
|
|
|
|
|
<div class="heading4">Financial/Grants Management Contact(s)</div>
|
|
|
|
<p class=regulartext>Ashley Ranellone<br>National Institute of Allergy and Infectious Diseases
|
|
(NIAID)<br>Telephone: 301-594-8541<br>Email: <a href="/cdn-cgi/l/email-protection#d6a4b7b8b3babab9b8b3b7b596b8bfb7bfb2f8b8bfbef8b1b9a0"><span class="__cf_email__" data-cfemail="295b48474c454546474c484a69474048404d07474041074e465f">[email protected]</span></a>
|
|
</p>
|
|
|
|
|
|
|
|
<p class=regulartext>James Williams<br>National Institute of Environmental Health Science (NIEHS)<br>Telephone: 984-287-3338<br>Email: <a href="/cdn-cgi/l/email-protection#5e29373232373f332d342c1e30373b362d7030373670393128"><span class="__cf_email__" data-cfemail="fb8c929797929a96889189bb95929e9388d5959293d59c948d">[email protected]</span></a>
|
|
</p>
|
|
|
|
|
|
|
|
|
|
<div class="heading2"><a name="_Toc258873273"></a><a
|
|
name="_Section_VIII._Other"></a>Section VIII. Other
|
|
Information</div>
|
|
|
|
<p class=regulartext>Recently issued trans-NIH <a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11163">policy
|
|
notices</a> may affect your application submission. A full list of policy
|
|
notices published by NIH is provided in the <a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11164"><i>NIH
|
|
Guide for Grants and Contracts</i></a>. All
|
|
awards are subject to the terms and conditions, cost principles, and other
|
|
considerations described in the <a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11120">NIH Grants Policy Statement</a>.</p>
|
|
|
|
<p class=regulartext> </p>
|
|
|
|
<div class="heading4">Authority and Regulations</div>
|
|
|
|
<p class=regulartext>Awards are made under the authorization of Sections 301 and
|
|
405 of the Public Health Service Act as amended (42 USC 241 and 284) and under
|
|
Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.</p>
|
|
|
|
</div>
|
|
|
|
|
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<A HREF="/grants/guide/WeeklyIndex.cfm?01-15-21">Weekly TOC for this Announcement</A><br>
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<A HREF="/grants/guide/index.html">NIH Funding Opportunities and Notices</A>
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