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<!-- From FOATemplate.txt -->
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<TITLE>Expired RFA-OD-19-029: The Intersection of Sex and Gender Influences on Health and Disease (R01 Clinical Trial Optional)</TITLE>
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<META NAME="description" CONTENT="NIH Funding Opportunities and Notices in the NIH Guide for Grants and Contracts: The Intersection of Sex and Gender Influences on Health and Disease (R01 Clinical Trial Optional) RFA-OD-19-029. ORWH">
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<META NAME="Keywords" CONTENT="RFA-OD-19-029: The Intersection of Sex and Gender Influences on Health and Disease (R01 Clinical Trial Optional)">
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<meta name="viewport" content="width=device-width, initial-scale=1.0">
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<link href="../guide_styles/css/bootstrap.min.css" rel="stylesheet">
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<link href="../guide_styles/css/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 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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<p style="clear:both;"> </p>
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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>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>Office of Research on Women’s Health (<a
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href="http://orwh.od.nih.gov">ORWH</a>)</p>
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<p>All applications to this
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funding opportunity announcement should fall within the mission of the
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Institutes/Centers. ORWH and SGMRO may co-fund applications assigned to
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those Institutes/Centers.</p>
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<p>National Center for Complementary and Integrative Health (<a
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href="http://www.nccam.nih.gov">NCCIH</a>)</p>
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<p>National Human Genome Research Institute (<a
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href="http://www.nhgri.nih.gov/">NHGRI</a>)</p>
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<p>National Institute on Aging (<a
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href="https://www.nia.nih.gov/">NIA</a>)</p>
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<p>National Institute on Alcohol Abuse and Alcoholism (<a
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href="http://www.niaaa.nih.gov">NIAAA</a>)<br>
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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 on Drug Abuse (<a href="http://www.nida.nih.gov">NIDA</a>)</p>
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<p>National Institute of Dental and Craniofacial Research (<a
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href="http://www.nidcr.nih.gov">NIDCR</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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National Institute of Mental Health (<a href="http://www.nimh.nih.gov">NIMH</a>) <br>
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National Institute of Nursing Research (<a href="http://www.ninr.nih.gov">NINR</a>)</p>
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<p>Sexual & Gender Minority
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Research Office (<a href="https://dpcpsi.nih.gov/sgmro">SGMRO</a>)</p>
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<p>National Heart, Lung, and Blood Institute (<a href="https://www.nhlbi.nih.gov/"> NHLBI </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">The Intersection
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of Sex and Gender Influences on Health and Disease (R01 Clinical
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Trial Optional)</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><a
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href="//grants.nih.gov/grants/funding/ac_search_results.htm?text_curr=r01&Search.x=0&Search.y=0&Search_Type=Activity">R01</a> Research Project Grant </p></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>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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<p><strong>October 13, 2022</strong> - This RFA has been reissued as <a href="//grants.nih.gov/grants/guide/rfa-files/RFA-OD-22-028.html">RFA-OD-22-028</a></p>
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<p><strong>October 28, 2021</strong> - Reminder: FORMS-G Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2022 - New Grant Application Instructions Now Available. See Notice <a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-22-018.html">NOT-OD-22-018</a>.
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</p>
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<p><strong>September 13, 2021</strong> - Updates to the Non-Discrimination Legal Requirements for NIH Recipients. See Notice
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<a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-181.html">NOT-OD-21-181</a>.
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</p>
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<p>
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<strong>August 5, 2021 </strong> - New NIH "FORMS-G" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2022. See Notice <a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-169.html">NOT-OD-21-169</a>.
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</p>
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<p><strong>August 5, 2021</strong> - Update: Notification of Upcoming Change in Federal-wide Unique Entity Identifier Requirements. See Notice <a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-170.html">NOT-OD-21-170</a>
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</p>
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<p><strong>April 20, 2021</strong> - Expanding Requirement for eRA Commons IDs to All Senior/Key Personnel. See Notice <a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-109.html">NOT-OD-21-109</a>
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</p>
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<p>
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<b>September 24, 2020 </b> - Notice of NHLBI Participation in RFA-OD-19-029. See Notice <a href="/grants/guide/notice-files/NOT-HL-20-812.html">NOT-HL-20-812</a>.</p>
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<p><b>September 15, 2020 </b> - Notice of Change: Expansion of Research Scope of RFA-OD-19-029. See Notice <a href="/grants/guide/notice-files/NOT-OD-20-168.html">NOT-OD-20-168</a>.</p> <p><b>June 19, 2020</b> - Notice of Change to NIA-Specific Text in RFA-OD-19-029. See Notice <a href="/grants/guide/notice-files/NOT-AG-20-037.html">NOT-AG-20-037</a>.</p>
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<p><b>March 10, 2020</b> - Reminder: FORMS-F Grant Application Forms & Instructions Must be Used for Due Dates On or After May 25, 2020- New Grant Application Instructions Now Available. See Notice <a href="/grants/guide/notice-files/NOT-OD-20-077.html">NOT-OD-20-077</a>. </p>
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<a
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href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-19-128.html">NOT-OD-19-128</a>,
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Changes to NIH Requirements Regarding Proposed Human Fetal Tissue Research.</p>
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<p><a
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href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-19-137.html">NOT-OD-19-137</a>,
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Clarifying Competing Application Instructions and Notice of Publication of
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Frequently Asked Questions (FAQs) Regarding Proposed Human Fetal Tissue
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Research.</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 Announcement (FOA) Number</div>
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<div class="col-md-8 datacolumn"><p class="title">RFA-OD-19-029</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>None </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>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> </sub></div>
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<div class="col-md-8 datacolumn"><p>93.313, 93.213, 93.172, 93.866, 93.273, 93.855, 93.279,
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93.121, 93.113, 93.361, 93.242, 93.837, 93.838, 93.939, 93.840, 93.233</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>The purpose of this Funding Opportunity Announcement (FOA)
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is to invite R01 applications on the influence and intersection of sex and
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gender in health and disease including: (1) research applications that
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examine sex and gender factors and their intersection in understanding health
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and disease; and (2) research that addresses one of
|
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the five objectives from Strategic Goal 1 of the new 2019-2023 <a
|
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href="https://orwh.od.nih.gov/sites/orwh/files/docs/ORWH_Strategic_Plan_2019_02_21_19_V2_508C.pdf">Trans-NIH
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Strategic Plan for Women's Health Research</a> "Advancing Science
|
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for the Health of Women." The awards under this FOA will be administered
|
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by NIH ICs using funds that have been made available through the Office of
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Research on Women’s Health (ORWH) and the scientific partnering Institutes
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and Centers across NIH.</p></div>
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</div><!--end row-->
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<br
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clear=all>
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<div class="heading2" style="clear:both;">Key Dates</div>
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<p style="clear:both;"> </p>
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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>September 27, 2019</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>October 25, 2019 </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>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>November 25, 2019; November 25, 2020, November 26, 2021 </p>
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<p>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(s)</p>
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<p>No late applications will be accepted for this Funding
|
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Opportunity Announcement</p>
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<p>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>November 25, 2019; November 25, 2020, November 26, 2021</p>
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<p>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
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AIDS and AIDS-related applications</a> allowed for this funding opportunity
|
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announcement are due on the listed date(s).</p>
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<p>No late applications will be accepted for this Funding
|
|
Opportunity Announcement</p>
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<p>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>February/March 2020; February/March 2021; February/March
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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">Advisory Council Review</div>
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<div class="col-md-8 datacolumn"><p>May 2020; May 2021; May 2022 <a
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href="http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward"></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">Earliest Start Date</div>
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<div class="col-md-8 datacolumn"><p>July 2020; July 2021; July 2022<a
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href="http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward"></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">Expiration Date</div>
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<div class="col-md-8 datacolumn"><p>November 27, 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>Not Applicable</p></div>
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</div><!--end row-->
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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>It is critical that applicants follow the Research (R)
|
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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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.assist_button {
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background-color: #4CAF50; /* Green */
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color: white;
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padding: 8px 16px;
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text-align: center;
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text-decoration: none;
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display: inline-block;
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font-size: 14px;
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.important {
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</style>
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<div class="heading1">Table of Contents</div>
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<p><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><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
|
|
name="_Toc258852635"></a><br>
|
|
<a name="_Part_2._Full"></a>Part 2.
|
|
Full Text of Announcement</div>
|
|
<div class="heading2"><a name="_Toc258873266"></a><a
|
|
name="_Toc258852636"></a><a name=IFundOppDesc></a><a name="_Section_I._Funding"></a>Section I. Funding Opportunity Description</div>
|
|
<p class="heading4"><strong>Purpose</strong></a></p>
|
|
<p>The purpose of this Funding Opportunity Announcement (FOA)
|
|
is to solicit R01 applications on the influence and intersection of sex and
|
|
gender in health and disease including: (1) research applications that examine
|
|
sex and gender factors and their intersection in understanding health and
|
|
disease; and (2) research that addresses one of the five objectives from
|
|
Strategic Goal 1 of the new 2019-2023 <a
|
|
href="https://orwh.od.nih.gov/sites/orwh/files/docs/ORWH_Strategic_Plan_2019_02_21_19_V2_508C.pdf">Trans-NIH
|
|
Strategic Plan for Women's Health Research</a> "Advancing Science for
|
|
the Health of Women.<u>" </u>The awards under this FOA will be
|
|
administered by NIH ICs using funds that have been made available through the
|
|
Office of Research on Women’s Health (ORWH) and the scientific partnering
|
|
Institutes and Centers across NIH. </p>
|
|
<p class="heading4"><strong>Background</strong></p>
|
|
<p>The Office of Research on Women’s Health (<a
|
|
href="https://orwh.od.nih.gov/">ORWH</a>) works in partnership with the NIH
|
|
Institutes, Centers and Offices (ICOs), as well as with federal agencies and
|
|
their offices to ensure that women's health research is an integral part of the
|
|
larger scientific framework to enhance heath and treat disease. The ORWH
|
|
mission includes strengthening research relevant to diseases, disorders, and
|
|
conditions that affect women and ensuring that research supported by NIH
|
|
adequately addresses issues regarding women’s health. The ORWH recently led the
|
|
development of the 2019-2023 <a
|
|
href="https://orwh.od.nih.gov/sites/orwh/files/docs/ORWH_Strategic_Plan_2019_02_21_19_V2_508C.pdf">Trans-NIH
|
|
Strategic Plan for Women's Health Research</a> , which offered a vision in
|
|
which the biomedical research enterprise thoroughly integrates sex and gender
|
|
influences so that every woman receives evidence-based
|
|
disease prevention and treatment tailored to her own needs, circumstances, and
|
|
goals. Within this strategic framework, this FOA focuses on the need to
|
|
better understand the influence and intersection of sex and gender. Research
|
|
supported by this FOA seeks to stimulate research advances on the influence of
|
|
sex and gender, lay the groundwork for innovative investigative approaches, and
|
|
improve health care tailored to women of all ages and backgrounds.</p>
|
|
<p>In the last decade, there has been growing recognition that,
|
|
disease prevalence, course and outcomes in women and men are influenced by both
|
|
biologic sex and gender. An increasing body of research suggests that there are
|
|
diseases that are unique to women, more common in women than in men, or
|
|
characterized by differences in disease course in women compared with men.
|
|
Research on the sex and gender factors that drive these crucial differences
|
|
however is limited. </p>
|
|
<p>The Institute of Medicine (IOM) report, "Exploring the
|
|
Biological Contributions to Human Health: Does Sex Matter?" (<a
|
|
href="http://www.nap.edu/read/10028/chapter/1">IOM Report, 2001</a>) defines the
|
|
term sex and gender. The terms are used to refer to separate but inextricably
|
|
linked influences in health. The terms however are often conflated or used
|
|
interchangeably. Sex and gender are conceptually complex, and our understanding
|
|
is likely to evolve with the availability of a more complete body of research. </p>
|
|
<p>Sex and gender are important considerations in many areas of
|
|
research, including basic biological, psychological, social, and behavioral
|
|
studies. Sex and gender are distinct concepts, but in human health their
|
|
influence is often inextricably linked and poorly understood. With continuous
|
|
interaction between sex and gender, human health is determined by both
|
|
biological sex and gender expression and identity, so both influences need to
|
|
be more fully integrated and elucidated in biomedical research. In 2015, ORWH
|
|
convened a workshop titled, Improving the Health of Women in the United States
|
|
(National Academies of Sciences, Engineering, and Medicine, 2016). Results from
|
|
the workshop revealed that many analyses of health data are not stratified by
|
|
sex or gender, making it difficult to fully understand the health of women or
|
|
to translate findings to provide evidence-based care. In addition, many gaps in
|
|
our understanding of diseases and conditions in women are the result of the
|
|
continued overreliance on male models (e.g. animals, cells) and the historical
|
|
overreliance on men as participants in clinical research. Interdisciplinary
|
|
approaches, routine sex-disaggregation of data, refined measurement tools, and
|
|
integrative approaches were deemed critical to addressing the health challenges
|
|
of women today.</p>
|
|
<p>With the implementation of the SABV Policy that went into
|
|
effect (<a
|
|
href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-102.html">NOT-OD-15-102</a>)
|
|
as part of the initiative to enhance Rigor and Reproducibility (<a
|
|
href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-103.html">NOT-OD-15-103</a>)
|
|
in 2016, as well as the <a
|
|
href="file:///C:/Users/mitchellm3/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/57XCVOSW/21st%20Century%20Cures%20Act">21st
|
|
Century Cures Act</a> that reinforces our efforts to advance women’s health,
|
|
there has been growing appreciation for the importance of sex and gender in
|
|
health and disease. A growing body of empirical data provides clear evidence
|
|
that women and men have different risks for the onset, expression, course,
|
|
pathophysiology, and treatment response in many disorders that occur at
|
|
different stages of development and throughout the life span. For example,
|
|
beginning in puberty, women are twice as likely as men to experience
|
|
depression and this increased risk is likely related to both sex and gender
|
|
influences. These sex and gender influences are not well understood however,
|
|
and many questions remain unanswered. A better understanding of this sex
|
|
difference could lead to major advancements in the diagnosis or treatment of Autism
|
|
Spectrum Disorder (ASD) in both males and females. </p>
|
|
<p class="heading4"><strong>Research
|
|
Objectives and Scope</strong></p>
|
|
<p>This announcement solicits research to target gaps in
|
|
knowledge regarding the influence and intersection of sex and gender on disease
|
|
conditions to improve understanding of the factors and mechanisms underlying
|
|
sex differences in health. The primary objectives of this announcement </p>
|
|
<p>include: (1) research applications that examine sex and
|
|
gender factors and their intersection in understanding health and disease; and
|
|
(2) research that addresses one of the five objectives from Strategic Goal 1 of
|
|
the new 2019-2023 <a
|
|
href="https://orwh.od.nih.gov/sites/orwh/files/docs/ORWH_Strategic_Plan_2019_02_21_19_V2_508C.pdf">Trans-NIH
|
|
Strategic Plan for Women's Health Research</a>. </p>
|
|
<p>For the purposes of this FOA, the following definitions are
|
|
utilized to describe and differentiate sex and gender-based factors:</p>
|
|
<p><strong>Sex-based
|
|
Factors</strong>: Biological variables defined by characteristics
|
|
encoded in DNA, such as reproductive organs and other physiological and
|
|
functional characteristics. See NIH Guide Notice NOT-OD-15-102 (<a
|
|
href="https://grants.nih.gov/grants/guide/notice-files/not-od-15-102.html">https://grants.nih.gov/grants/guide/notice-files/not-od-15-102.html</a>). </p>
|
|
<p><strong>Gender-based
|
|
Factors</strong>: Social, environmental, cultural, and behavioral
|
|
factors including individual gender identity and the choices that influence a
|
|
person’s self-identity and health (Clayton and Tannenbaum, 2016 <a
|
|
href="https://jamanetwork.com/journals/jama/fullarticle/2577142">https://jamanetwork.com/journals/jama/fullarticle/2577142</a>).</p>
|
|
<p><strong>In
|
|
order to be responsive to this FOA, application must address all of the
|
|
following:</strong></p>
|
|
<p>(1) Include one or more sex-based
|
|
variables, including but not limited to: evaluation of sex as a biological
|
|
variable; sex-based comparisons on conditions in females and males; biologically
|
|
based variables such as hormones, physical features, anatomy, or biomarkers.</p>
|
|
<p>(2) Include one or more gender-based variables, including
|
|
but not limited to: assessment of psychosocial variables relevant to health
|
|
conditions; measures of socially constructed roles, experiences, identities, or
|
|
behaviors of girls, women, boys, men, or gender diverse people.</p>
|
|
<p>(3) The intersection of sex and gender. </p>
|
|
<p>(4) One of the five objectives from Strategic Goal 1 of the
|
|
new 2019-2023 <a
|
|
href="https://orwh.od.nih.gov/sites/orwh/files/docs/ORWH_Strategic_Plan_2019_02_21_19_V2_508C.pdf">Trans-NIH
|
|
Strategic Plan for Women's Health Research</a>. </p>
|
|
<p><strong>The
|
|
strategic plan for Goal 1 has the following objectives:</strong></p>
|
|
<p class=Bullet>1.1 <b>Discover
|
|
basic biological differences between females and males.</b> Studying female and
|
|
male cells, organs, and biological systems is necessary to improve our
|
|
understanding of the mechanisms by which sex influences health and disease.
|
|
Research that examines the possible influences of sex on both normal biology
|
|
and pathophysiology is critical. Generating fundamental knowledge about female
|
|
biology and scientifically meaningful sex differences in both normal and
|
|
abnormal processes strengthens the foundation for the design of rigorous
|
|
preclinical and clinical studies that account for sex as a biological variable,
|
|
enhancing their relevance to the health of women.</p>
|
|
<p class=Bullet>1.2 <b>Investigate
|
|
the influence of sex and gender on disease prevention, presentation,
|
|
management, and outcomes.</b> Sex and gender factors and their intersection
|
|
influence the course of many diseases, including risk and protective factors,
|
|
presentation, treatment, and recovery. Gaps in knowledge about these influences
|
|
remain for many illnesses and chronic diseases affecting women, including the
|
|
effects of comorbidities. Identifying meaningful effects of sex and gender on
|
|
diseases and understanding how these influences affect the health of women will
|
|
address sex- and gender-based disease burden, contribute to a more individualized
|
|
approach to health care, promote disease prevention, and improve quality of
|
|
life.</p>
|
|
<p class=Bullet>1.3 <b>Identify
|
|
the immediate, mid-, and long-term effects of exposures on health and disease
|
|
outcomes.</b> Various types of exposures affect disease risk across different
|
|
timescales, ranging from an immediate outcome at the time of exposure to a
|
|
delayed outcome that becomes evident at a later stage in life. Exposures
|
|
include, but are not limited to, factors such as the microbiome, exogenous
|
|
hormones, environmental toxins, the built environment, and behavior-related
|
|
exposures such as physical activity, sleep, and nutrition. Additional exposures
|
|
include social and psychological exposures such as stress and trauma across the
|
|
life course; discrimination and stigma; caregiving; and factors linked to
|
|
resilience, such as social support and family cohesion. Socioeconomic exposures
|
|
such as poverty, family and community resources, educational attainment, and
|
|
access to health care are also relevant to the health of women. Identifying the
|
|
effects of exposures can inform the use of preventive interventions to reduce
|
|
disease risk and promote well-being.</p>
|
|
<p class=Bullet>1.4 <b>Promote
|
|
research that explores the influence of sex and gender on the connection
|
|
between the mind and body, and its impact on health and disease.</b> Research
|
|
is needed to understand the mechanisms of mind and body connections, including
|
|
their dysregulation, and their impact on behavior and cognition. Such studies
|
|
are particularly relevant to certain conditions that differentially affect
|
|
women such as pain, depression, sleep disorders, obesity, cardiovascular
|
|
disease, and metabolic disturbances. Investigating the relationship between
|
|
mental and physical factors and health outcomes can help identify opportunities
|
|
for prevention, mitigate disease risk, and manage disease progression.</p>
|
|
<p class=Bullet>1.5 <b>Expand
|
|
research on female-specific conditions and diseases, including reproductive
|
|
stages, and maternal and gynecologic health.</b> There is a need for focused
|
|
investigation of female reproductive health and illness, including menstruation
|
|
(normal and dysfunctional), infertility, pregnancy, lactation, and menopause.
|
|
Additionally, there is a need for increased attention to research gynecologic
|
|
health and disease in women of all ages. Maternal health is critically
|
|
important to the health of a woman during pregnancy and throughout her life
|
|
course, and for the health of her children. Because the maternal mortality rate
|
|
in U.S. women is on the rise (<a
|
|
href="https://www.ncbi.nlm.nih.gov/pubmed/27733286">GBD 2015 Maternal Mortality
|
|
Collaborators, 2016</a>), particularly in women of color, investigation of
|
|
disparities in mortality and morbidity related to pregnancy is needed.</p>
|
|
<p>In addition, applications submitted in response to this FOA
|
|
are encouraged to consider: </p>
|
|
<p><em>Health
|
|
Disparities:</em> Women are disproportionately affected by some
|
|
conditions and diseases in terms of incidence, diagnosis, course, and response
|
|
to treatment. Some populations of women may be at higher risk for adverse
|
|
disease outcomes because of factors such as: biology, genes, culture,
|
|
education, sexual orientation, gender expression or identity, effects of
|
|
poverty, access to care, quality of care, and access to opportunities for
|
|
inclusion as research subjects in clinical trials and studies. </p>
|
|
<p><em>Life
|
|
course/Lifespan:</em> The health of girls and women is affected by
|
|
developmental, physiological, and psychological age. Women’s lives are
|
|
marked by a continuum from intrauterine life to the elderly years: infancy,
|
|
childhood and adolescence, menarche, reproductive life, the menopausal
|
|
transition, postmenopausal years, the elderly, and the frail elderly.
|
|
Each of these factors may influence health, disease, lifestyle, treatment
|
|
choices, and response to therapy.</p>
|
|
<p><strong>Research
|
|
Scope</strong></p>
|
|
<p>This FOA supports basic, preclinical, translational and
|
|
clinical research investigations composed of teams who share expertise,
|
|
knowledge, and skills in the following research formats:</p>
|
|
<p>Interdisciplinary or
|
|
transdisciplinary research that includes collaborations across a range of
|
|
disciplines, including but not limited to, economics, medical anthropology,
|
|
psychology, and demography to address research from a multi-disciplinary
|
|
perspective that may address gaps in the fuller context of women's lives and
|
|
the underlying common root causes of poorer health outcomes.</p>
|
|
<p>In addition to new, cross-cutting interdisciplinary
|
|
research, studies that leverage existing funded cohorts and datasets for
|
|
analyses of hypotheses related to sex and gender influences in health and
|
|
disease are of high interest. Comparative analyses of existing
|
|
samples/datasets/databases and/or data-mining and data curation to investigate
|
|
the role of sex/gender are encouraged. </p>
|
|
<p>This FOA is designed to stimulate research that incorporates
|
|
and/or enhances understanding of the influence of sex and gender and their
|
|
intersectionality in health outcomes. For further information on NIH's
|
|
expectations about consideration of sex as a biological variable, and NIH's
|
|
initiative to improve reproducibility through rigor and transparency, please
|
|
see the following Notices published in the NIH Guide: <a
|
|
href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-102.html">NOT-OD-15-102</a>, <a
|
|
href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-103.html">NOT-OD-15-103</a>, <a
|
|
href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-011.html">NOT-OD-16-011</a>, <a
|
|
href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-012.html">NOT-OD-16-012</a>.</p>
|
|
<p><b>Areas of Interest of
|
|
Participating Institutes, Centers and Offices</b></p>
|
|
<p>The participating NIH ICOs below identify priority research
|
|
approaches and specific topics within the scope of their institute’s scientific
|
|
mission and consistent with their interests toward a better understanding of
|
|
the intersection of sex and gender in health and disease.</p>
|
|
<p><b>The </b><b>National Center for Complementary and
|
|
Integrative Health (NCCIH)</b><b> </b></p>
|
|
<p>The mission of the <a
|
|
href="https://nccih.nih.gov/">National Center for Complementary and Integrative
|
|
Health (NCCIH)</a> is to define, through
|
|
rigorous scientific investigation, the usefulness and safety of complementary
|
|
and integrative health interventions and their role in improving health and
|
|
health care. For the purposes of this FOA, NCCIH is interested in research on the
|
|
contributions of sex, gender, and the intersection of sex and gender on the
|
|
mechanisms of action of complex interventions including various mind and body
|
|
approaches and natural products. NCCIH is also interested in research that
|
|
investigates the influence of sex and gender on utilization of these approaches
|
|
to improve health outcomes among diverse populations, including gender diverse
|
|
populations. Natural products include botanicals, pre/probiotics, and products
|
|
marketed as dietary supplements. Mind and body approaches include various
|
|
meditation approaches (e.g., mindfulness), hypnosis or guided imagery,
|
|
meditative movement approaches (e.g., yoga, tai chi, qi-gong), body-based
|
|
approaches (e.g., spinal manipulation, massage, mobilization, acupuncture), a combination
|
|
of these approaches (e.g., meditation and yoga, such as in mindfulness-based
|
|
stress reduction MBSR), or complex interventions including music and art
|
|
therapy. NCCIH will not accept single-site or multi-site efficacy or
|
|
effectiveness research through this FOA (please see <a
|
|
href="https://nccih.nih.gov/grants/funding/clinicaltrials">NCCIH Clinical Trial
|
|
Funding Opportunities</a> instead). NCCIH will accept assignment of applications in the
|
|
area of complementary and integrative health that do not propose clinical
|
|
trials, such as observational, basic, and mechanistic (animal) studies. Investigators
|
|
are strongly encouraged to discuss their plans with NCCIH Scientific/Research
|
|
contact prior to submitting their application to identify the most appropriate
|
|
FOA for their research.</p>
|
|
<p><b>National Human Genome Research Institute (NHGRI) </b></p>
|
|
<p>NHGRI will support the development of resources, approaches,
|
|
and technologies that will accelerate genomic research on the structure of
|
|
genomes, the biology of genomes, and the biology of disease; that will use
|
|
genomics to advance the science of medicine; and that will incorporate genomics
|
|
to improve the effectiveness of healthcare. NHGRI will also support genomic
|
|
research in several cross-cutting areas, including the ethical, legal and
|
|
societal implications of genomics and genetics research, bioinformatics,
|
|
technology development, and research training and career development.</p>
|
|
<p>In general, NHGRI supports studies that provide
|
|
generalizable methods and knowledge. Applications for studies relevant
|
|
only to a particular disease or organ system should be directed to the
|
|
appropriate Institute or Center. NHGRI strongly encourages potential
|
|
applicants to contact program staff in the early stages of developing your
|
|
application. The contact information for the three scientific programs are:</p>
|
|
<p>Division of Genome Science: <a
|
|
href="https://www.genome.gov/27550609/division-of-genome-sciences-staff/">https://www.genome.gov/27550609/division-of-genome-sciences-staff/</a> </p>
|
|
<p>Division of Genomic Medicine: <a
|
|
href="https://www.genome.gov/27550610/division-of-genomic-medicine-staff/">https://www.genome.gov/27550610/division-of-genomic-medicine-staff/</a> </p>
|
|
<p>Division of Genomics and Society: <a
|
|
href="https://www.genome.gov/27550080/division-of-genomics-and-society/">https://www.genome.gov/27550080/division-of-genomics-and-society/</a></p>
|
|
<p><b>National Institute on
|
|
Aging</b> <b>(NIA)</b></p>
|
|
<p>The National Institute on Aging
|
|
invites research that examines sex and gender factors and their intersections
|
|
to improve understanding of health and disease in the context of Alzheimer s
|
|
disease and related dementias. Research in NIA applications must focus on a
|
|
high-priority topic of interest specified in <a
|
|
href="https://grants.nih.gov/grants/guide/pa-files/par-19-070.html">PAR-19-070</a>: "Research on Current Topics in
|
|
Alzheimer's Disease and Its Related Dementias (R01 Clinical Trial
|
|
Optional)". </p>
|
|
<p><b>National Institute of Allergy and Infectious Diseases
|
|
(NIAID) </b></p>
|
|
<p>Areas of programmatic interest to NIAID include, but are not
|
|
limited to, the following:</p>
|
|
<ul>
|
|
<li>Research on all areas of HIV infection, including developing and
|
|
testing preventive HIV vaccines, and other non-vaccine biomedical prevention
|
|
strategies such as systemic protecting long-acting post-exposure prophylaxis
|
|
(PrEP) and Multipurpose Prevention Technologies [MPT], and new strategies for
|
|
controlling or eliminating HIV infection and AIDS-associated opportunistic
|
|
infections</li>
|
|
<li>Basic and applied research to better understand, treat, and
|
|
ultimately prevent other infectious, immunologic, and allergic diseases</li>
|
|
</ul>
|
|
<p><b>National Institute on Alcohol Abuse and Alcoholism
|
|
(NIAAA)</b></p>
|
|
<p>NIAAA is interested in supporting basic, preclinical,
|
|
translational and clinical research applications that will examine the
|
|
influence of sex and gender on treatment, prevention, and management of alcohol
|
|
use disorder.</p>
|
|
<p>NIAAA priorities are as follows:</p>
|
|
<ul>
|
|
<li>lmpact of factors including stress and trauma across the lifespan
|
|
and sleep on sex and gender leading to alcohol use, addiction, or cessation of
|
|
consumption. </li>
|
|
<li>Effects of sex and gender and their interaction on alcohol
|
|
withdrawal and relapse.</li>
|
|
</ul>
|
|
<p><b>The National Institute on Drug Abuse (NIDA)</b></p>
|
|
<p>NIDA<b> </b>invites applications that investigate the
|
|
intersection of sex and gender factors in vulnerability to substance use and
|
|
addiction, its consequences, and treatment and prevention outcomes.</p>
|
|
<p><b>National Institute of Dental and Craniofacial Research
|
|
(NIDCR)</b></p>
|
|
<p>NIDCR encourages applications that address mechanisms
|
|
underlying the manifestations of sex- and gender-based differences in Dental,
|
|
Oral, and Craniofacial (DOC)-related diseases and
|
|
conditions. Specifically, NIDCR encourages studies aimed at understanding
|
|
immune reactivity, genetic variation, environmental triggers, aging, and
|
|
hormonal changes as they affect sex- and gender-based differences. Further,
|
|
NIDCR encourages clinical research studies that address the influence of sex
|
|
and gender on oral disease prevention, diagnosis, and management, and studies
|
|
that assess the influence of sex and gender on oral health outcomes.
|
|
Investigators proposing clinical trials must use NIDCR’s UG3/UH3 mechanism.
|
|
Please see <a
|
|
href="https://grants.nih.gov/grants/guide/notice-files/NOT-DE-18-014.html">NOT-DE-18-014</a> for information about NIDCR’s clinical trials program. All applicants are
|
|
strongly encouraged to discuss potential requests with the NIDCR Program
|
|
Officer listed in the Scientific/Research Contacts<b><i>.</i></b></p>
|
|
<p><strong>National
|
|
Institute of Environmental Health Sciences (NIEHS)</strong></p>
|
|
<p>Research areas must focus on interests within the mission of
|
|
NIEHS. Examples include research on sex and gender influences in health and
|
|
disease in response to environmental exposures; research on environmental
|
|
exposures and sex and gender influences in fundamental biology across the
|
|
lifespan; research focused on better understanding the role of environmental
|
|
exposures and sex and gender influences in relation to pregnancy, reproductive
|
|
disorders and disease, metabolic diseases, cancers, metabolic disease,
|
|
cardiovascular disease, and other disease conditions.</p>
|
|
<p><b>National Institute of Mental Health (NIMH)</b></p>
|
|
<p>NIMH will only accept HIV/AIDS applications. Mental health
|
|
applications that do not study HIV/ AIDS are non-responsive and will not be
|
|
reviewed. </p>
|
|
<p>Specific Areas of Research Interest for:</p>
|
|
<p>High priority areas of research within this announcement
|
|
include, but are not limited to, the following:</p>
|
|
<p>1.Studies to better understand the interplay between gender
|
|
affirming hormone therapy, gender identity, and sex at birth, and how
|
|
interactions between those factors impact HIV prevention and treatment
|
|
outcomes.</p>
|
|
<p>2. Intervention research to improve HIV prevention and
|
|
treatment outcomes for transgender individuals that focuses on the influences
|
|
of sex and gender.</p>
|
|
<p>3. Studies to better understand the differential
|
|
effects of sex and gender on neurocognitive outcomes among people living with
|
|
HIV.</p>
|
|
<p>4. Studies to understand how the interactive effects of
|
|
sex and gender influence intersectional stigma, trauma/violence, mental health
|
|
and, ultimately, HIV prevention or treatment outcomes</p>
|
|
<p><b>National Institute of Nursing
|
|
Research (NINR)</b></p>
|
|
<p>The
|
|
mission of the NINR is to promote and improve the health of individuals,
|
|
families, and communities by supporting research that spans and integrates the
|
|
behavioral and biological sciences, and that develops the scientific basis for
|
|
clinical practice. NINR supports research on a range of topics in women s
|
|
health within NINR’s four areas of scientific focus: symptom science, wellness,
|
|
self-management of chronic conditions, and end-of-life and palliative care
|
|
research. NINR is especially interested in applications that propose
|
|
research on sex/gender influences in HIV/AIDS research.</p>
|
|
<p><a name="_Section_II._Award_1"></a>See <a
|
|
href="#_Section_VIII._Other">Section
|
|
VIII. Other Information</a> for award authorities and regulations.</p>
|
|
<div class="heading2">Section II. Award
|
|
Information</div>
|
|
|
|
|
|
|
|
<div class="row">
|
|
<div class="col-md-4 datalabel">Funding Instrument</div>
|
|
<div class="col-md-8 datacolumn"><p>Grant: A support mechanism
|
|
providing money, property, or both to an eligible entity to carry out an
|
|
approved project or activity. </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>New</p>
|
|
<p class=regulartext>Resubmission
|
|
</p>
|
|
<p>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>Optional: Accepting applications that either propose or do
|
|
not propose clinical trial(s)</p>
|
|
<p><a
|
|
href="https://grants.nih.gov/grants/guide/url_redirect.htm?id=82370">Need
|
|
help determining whether you are doing a clinical trial?</a></p></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>The number of awards is contingent upon NIH appropriations
|
|
and the submission of a sufficient number of meritorious applications.</p>
|
|
<p>ORWH and partner <a href="#_Components_of_Participating">components</a> intend to commit an estimated total of $3 million to fund up to 7 awards. The
|
|
number of awards depends on the size and scope of the most meritorious
|
|
applications, scientific programmatic interest, and availability of funds.</p></div>
|
|
</div><!--end row-->
|
|
|
|
|
|
<div class="row">
|
|
<div class="col-md-4 datalabel">Award Budget</div>
|
|
<div class="col-md-8 datacolumn"><p>Application budgets may not
|
|
exceed direct costs of $350,000 per year. </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>The total project period
|
|
for an application submitted in response to this FOA may not exceed 4 years. </p></div>
|
|
</div><!--end row-->
|
|
|
|
|
|
|
|
|
|
<p>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>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>Nonprofits Other Than Institutions of Higher Education</p>
|
|
<ul>
|
|
<li>Nonprofits with 501(c)(3) IRS Status (Other than Institutions of
|
|
Higher Education) </li>
|
|
<li>Nonprofits without 501(c)(3) IRS Status (Other than Institutions
|
|
of Higher Education) </li>
|
|
</ul>
|
|
<p>For-Profit Organizations</p>
|
|
<ul>
|
|
<li>Small Businesses</li>
|
|
<li>For-Profit Organizations (Other than Small Businesses)</li>
|
|
</ul>
|
|
<p>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>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>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 not</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"><a name="_Required_Registrations"></a>Required
|
|
Registrations</div>
|
|
<p><strong>Applicant
|
|
Organizations</strong></p>
|
|
<p>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, <strong>which requires renewal at least
|
|
annually</strong>. The renewal process may require as much time as the
|
|
initial registration. SAM registration includes the assignment of a Commercial
|
|
and Government Entity (CAGE) Code for domestic organizations which have not
|
|
already been assigned a CAGE Code. </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><strong>Program
|
|
Directors/Principal Investigators (PD(s)/PI(s)) </strong></p>
|
|
<p>All PD(s)/PI(s) must have an eRA Commons account.
|
|
PD(s)/PI(s) should work with their organizational officials to either
|
|
create a new account or to affiliate their existing account with the applicant
|
|
organization in eRA Commons. If the PD/PI is also the organizational Signing
|
|
Official, they must have two distinct eRA Commons accounts, one for each role.
|
|
Obtaining an eRA Commons account can take up to 2 weeks.</p>
|
|
<div class="heading4">Eligible Individuals (Program Director/Principal Investigator)</div>
|
|
<p>Any individual(s) with the skills, knowledge, and resources
|
|
necessary to carry out the proposed research as the Program
|
|
Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with
|
|
his/her organization to develop an application for support. Individuals from
|
|
underrepresented racial and ethnic groups as well as individuals with
|
|
disabilities are always encouraged to apply for NIH support.</p>
|
|
<p>For institutions/organizations proposing multiple PDs/PIs,
|
|
visit the Multiple Program Director/Principal Investigator Policy and
|
|
submission details in the Senior/Key Person Profile (Expanded) Component of the
|
|
SF424 (R&R) Application Guide. </p>
|
|
<div class="heading3">2. Cost Sharing</div>
|
|
<p>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>Applicant organizations may submit more than one application,
|
|
provided that each application is scientifically distinct. </p>
|
|
<p>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="//grants.nih.gov/grants/guide/notice-files/NOT-OD-11-101.html">NOT-OD-11-101</a>).</li>
|
|
</ul>
|
|
<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>The application forms package specific to this opportunity
|
|
must be accessed through ASSIST, Grants.gov Workspace or an institutional
|
|
system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are
|
|
available in <a href="#_Required_Application_Instructions">Part 1</a> of this
|
|
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>It is critical that applicants follow the Research (R)
|
|
Instructions in the <a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=12000">SF424
|
|
(R&R) Application Guide</a>, except where instructed in this funding
|
|
opportunity announcement to do otherwise. Conformance to the requirements in
|
|
the Application Guide is required and strictly enforced. Applications that are
|
|
out of compliance with these instructions may be delayed or not accepted for
|
|
review.</p>
|
|
<div class="heading4">Letter of Intent </div>
|
|
<p>Although a letter of intent is not required, is not binding,
|
|
and does not enter into the review of a subsequent application, the information
|
|
|
|
that it contains allows IC staff to estimate the potential review workload and
|
|
plan the review. </p>
|
|
<p>By the date listed in <a href="#_Part_1._Overview">Part 1. Overview
|
|
Information</a>, prospective applicants are asked to submit a letter of intent
|
|
that includes the following information:</p>
|
|
<ul>
|
|
<li>Descriptive title of proposed activity</li>
|
|
<li>Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)</li>
|
|
<li>Names of other key personnel</li>
|
|
<li>Participating institution(s)</li>
|
|
<li>Number and title of this funding opportunity </li>
|
|
</ul>
|
|
<p>The letter of intent should be sent to: </p>
|
|
<p class=P_SingleIndent>Rebecca DelCarmen-Wiggins, Ph.D.<br>
|
|
Telephone: 301-451-8689<br>
|
|
Email: <a href="/cdn-cgi/l/email-protection#4c3e2829202f2d3e210c212d252062222524622b233a"><span class="__cf_email__" data-cfemail="7d0f1918111e1c0f103d101c141153131415531a120b">[email protected]</span></a> </p>
|
|
<div class="heading4">Page Limitations</div>
|
|
<p>All page limitations described in the SF424 Application
|
|
Guide and the <a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11133">Table of
|
|
Page Limits</a> must be followed. </p>
|
|
<div class="heading4">Instructions for Application Submission</div>
|
|
<p>The following section supplements the instructions found in
|
|
the SF424 (R&R) Application Guide and should be used for preparing an
|
|
application to this FOA.</p>
|
|
<div class="heading4">SF424(R&R) Cover</div>
|
|
<p>All instructions in the SF424 (R&R) Application Guide
|
|
must be followed. </p>
|
|
<div class="heading4">SF424(R&R) Project/Performance Site Locations</div>
|
|
<p>All instructions in the SF424 (R&R) Application Guide
|
|
must be followed. </p>
|
|
<div class="heading4">SF424(R&R) Other Project Information</div>
|
|
<p>All instructions in the SF424 (R&R) Application Guide
|
|
must be followed. </p>
|
|
<div class="heading4">SF424(R&R) Senior/Key Person Profile </div>
|
|
<p>All instructions in the SF424 (R&R) Application Guide
|
|
must be followed. </p>
|
|
<div class="heading4">R&R or Modular Budget</div>
|
|
<p>All instructions in the SF424 (R&R) Application Guide
|
|
must be followed. </p>
|
|
<div class="heading4">R&R Subaward Budget</div>
|
|
<p>All instructions in the SF424 (R&R) Application Guide
|
|
must be followed. </p>
|
|
<div class="heading4">PHS 398 Cover Page Supplement</div>
|
|
<p>All instructions in the SF424 (R&R) Application Guide
|
|
must be followed. </p>
|
|
<div class="heading4">PHS 398 Research Plan</div>
|
|
<p>All instructions in the SF424 (R&R) Application Guide
|
|
must be followed, with the following additional instructions: </p>
|
|
<p><strong>Research
|
|
Strategy: </strong>Applicants must <b>address all of the following</b>:</p>
|
|
<ul>
|
|
<li>Describe the inclusion of one or more sex-based variable(s):
|
|
Evaluation of sex as a biological variable; sex- based comparisons on
|
|
conditions in females and males; biologically based variables such as hormones,
|
|
physical features, anatomy, or biomarkers.</li>
|
|
<li>Describe the inclusion of one or more gender-based variable(s)
|
|
such as assessment of psychosocial variables relevant to health conditions;
|
|
measures of socially constructed roles, experiences, identities, or behaviors
|
|
of girls, women, boys, men, or gender diverse people.</li>
|
|
<li>Address the intersection of sex and gender: Include integrative
|
|
discussions that address the intersection of sex and gender in the context of
|
|
advancing a better understanding of health and disease. Studies relevant to
|
|
understanding the intersection of sex and gender can include sex-based
|
|
comparisons of gender-related variables.</li>
|
|
<li>Address one of the five objectives from Strategic Goal 1 of the
|
|
new 2019-2023 <a
|
|
href="https://orwh.od.nih.gov/sites/orwh/files/docs/ORWH_Strategic_Plan_2019_02_21_19_V2_508C.pdf">Trans-NIH
|
|
Strategic Plan for Women's Health Research</a>. The Trans-NIH Strategic Plan
|
|
includes five major research priorities which provides an optimal and timely
|
|
framework for this FOA. These include research to:</li>
|
|
</ul>
|
|
<p>1.1 Discover
|
|
biological differences between females and males.</p>
|
|
<p>1.2 Investigate
|
|
the influence of sex and gender on disease prevention, presentation,
|
|
management, and outcomes. </p>
|
|
<p>1.3 Identify
|
|
the immediate, mid-, and long-term effects of exposures on health and disease
|
|
outcomes.</p>
|
|
<p>1.4 Promote
|
|
research that explores the influence of sex and gender on the connection
|
|
between the mind and body, and its impact on health and disease.</p>
|
|
<p>1.5 Expand
|
|
research on female-specific conditions and diseases including reproductive
|
|
stages, and maternal and gynecologic health.</p>
|
|
<p>The strategic plan endorsed by the
|
|
NIH Director in March 2019 is the result of a collective effort, based on input
|
|
from periodic strategic planning working group meetings, guidance from the
|
|
Advisory Council on Research on Women’s Health (ACRWH), and recommendations
|
|
from the Coordinating Committee on Research on Women's Health (CCRWH), composed
|
|
of representatives from the NIH Institutes and Centers For more information,
|
|
applicants are encouraged to review the ORWH website.</p>
|
|
<p><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>
|
|
</ul>
|
|
<p><strong>Appendix: </strong></p>
|
|
<p>Only limited Appendix materials are allowed. Follow all
|
|
instructions for the Appendix as described in the SF424 (R&R) Application
|
|
Guide. </p>
|
|
<div class="heading4">PHS Human Subjects and Clinical Trials Information</div>
|
|
<p>When involving human subjects research, clinical research,
|
|
and/or NIH-defined clinical trials (and when applicable, clinical trials
|
|
research experience) follow all instructions for the PHS Human Subjects and
|
|
Clinical Trials Information form in the SF424 (R&R) Application Guide, with
|
|
the following additional instructions:</p>
|
|
<p>If you answered Yes to the question Are Human Subjects
|
|
Involved? on the R&R Other Project Information form, you must include at
|
|
least one human subjects study record using the <strong>Study Record: PHS Human Subjects and Clinical Trials
|
|
Information </strong>form or <strong>Delayed
|
|
Onset Study</strong> record. </p>
|
|
<p><strong>Study
|
|
Record: PHS Human Subjects and Clinical Trials Information</strong></p>
|
|
<p>All instructions in the SF424 (R&R) Application Guide
|
|
must be followed.</p>
|
|
<p><strong>Delayed
|
|
Onset Study</strong></p>
|
|
<p>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>All instructions in the SF424 (R&R) Application Guide
|
|
must be followed. </p>
|
|
<div class="heading4">PHS Assignment Request Form</div>
|
|
<p>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>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><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>Organizations must submit applications to <a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11128"
|
|
target="_blank">Grants.gov</a> (the online portal to find and apply for grants
|
|
across all Federal agencies). Applicants must then complete the submission
|
|
process by tracking the status of the application in the <a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11123"
|
|
target="_blank">eRA Commons</a>, NIH’s electronic system for grants
|
|
administration. NIH and Grants.gov systems check the application against many
|
|
of the application instructions upon submission. Errors must be corrected and a
|
|
changed/corrected application must be submitted to Grants.gov on or before the application
|
|
due date and time. If a Changed/Corrected application is submitted after the
|
|
deadline, the application will be considered late. Applications that miss the
|
|
due date and time are subjected to the NIH Policy on Late Application
|
|
Submission.</p>
|
|
<p><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>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>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>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>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>Applications must be submitted electronically following the
|
|
instructions described in the SF424 (R&R) Application Guide. Paper applications
|
|
will not be accepted. </p>
|
|
<p><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>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=P_SingleIndent><strong>Important
|
|
reminders:</strong></p>
|
|
<p class=P_SingleIndent>All PD(s)/PI(s) 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. See <a
|
|
href="#_Required_Registrations">Section III</a> of this FOA for information on
|
|
registration requirements.</p>
|
|
<p class=P_SingleIndent>The applicant organization must ensure that the DUNS
|
|
number it provides on the application is the same number used in the
|
|
organization’s profile in the eRA Commons and for the System for Award
|
|
Management. Additional information may be found in the SF424 (R&R)
|
|
Application Guide.</p>
|
|
<p class=P_SingleIndent>See <a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11146">more tips</a> for avoiding common errors. </p>
|
|
<p>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>
|
|
<p>In order to expedite review, applicants are requested to
|
|
notify the ORWH Program Officer, Dr. Rebecca DelCarmen-Wiggins at <a href="/cdn-cgi/l/email-protection#9eecfafbf2fdffecf3def3fff7f2b0f0f7f6b0f9f1e8"><span class="__cf_email__" data-cfemail="691b0d0c050a081b04290408000547070001470e061f">[email protected]</span></a>, when the
|
|
application has been submitted. Please include the FOA number and title, PD/PI
|
|
name, and title of the application.</p>
|
|
<div class="heading4"><a name="_Toc258873270"> </a></div>
|
|
<div class="heading4">Post Submission Materials</div>
|
|
<p>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>Only the review criteria described below will be considered
|
|
in the review process. </p>
|
|
<p>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>
|
|
<p><b>In addition, for
|
|
applications involving clinical trials:</b></p>
|
|
<p>A proposed Clinical Trial
|
|
application may include study design, methods, and intervention that are not by
|
|
themselves innovative but address important questions or unmet needs.
|
|
Additionally, the results of the clinical trial may indicate that further
|
|
clinical development of the intervention is unwarranted or lead to new avenues
|
|
of scientific investigation.</p>
|
|
<div class="heading4">Overall Impact </div>
|
|
<p>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>
|
|
<div class="heading4">Scored Review Criteria</div>
|
|
<p>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>
|
|
<div class="heading4Indent">Significance</div>
|
|
<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><em>Specific to this FOA: </em></strong></p>
|
|
<p class=P_SingleIndent>Is there a clear justification for the sex-based and
|
|
gender-based variables that will be included in the study? </p>
|
|
<p class=P_SingleIndent><strong>In
|
|
addition, for applications involving clinical trials</strong></p>
|
|
<p class=P_SingleIndent>Are the scientific
|
|
rationale and need for a clinical trial to test the proposed hypothesis or
|
|
intervention well supported by preliminary data, clinical and/or preclinical
|
|
studies, or information in the literature or knowledge of biological
|
|
mechanisms? For trials focusing on clinical or public health endpoints, is this
|
|
clinical trial necessary for testing the safety, efficacy or effectiveness of
|
|
an intervention that could lead to a change in clinical practice, community
|
|
behaviors or health care policy? For trials focusing on mechanistic,
|
|
behavioral, physiological, biochemical, or other biomedical endpoints, is this
|
|
trial needed to advance scientific understanding?</p>
|
|
<div class="heading4Indent">Investigator(s)</div>
|
|
<p class="P_SingleIndent">Are the PD(s)/PI(s), collaborators,
|
|
and other researchers well suited to the project? If Early Stage Investigators
|
|
or those in the early stages of independent careers, do they have appropriate
|
|
experience and training? If established, have they demonstrated an ongoing
|
|
record of accomplishments that have advanced their field(s)? If the project is
|
|
collaborative or multi-PD/PI, do the investigators have complementary and
|
|
integrated expertise; are their leadership approach, governance and
|
|
organizational structure appropriate for the project?</p>
|
|
<p class=P_SingleIndent><strong>In
|
|
addition, for applications involving clinical trials</strong></p>
|
|
<p class="P_SingleIndent">With
|
|
regard to the proposed leadership for the project, do the PD/PI(s) and key
|
|
personnel have the expertise, experience, and ability to organize, manage and
|
|
implement the proposed clinical trial and meet milestones and timelines? Do
|
|
they have appropriate expertise in study coordination, data management and
|
|
statistics? For a multicenter trial, is the organizational structure
|
|
appropriate and does the application identify a core of potential center
|
|
investigators and staffing for a coordinating center? </p>
|
|
<div class="heading4Indent">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>
|
|
<p class=P_SingleIndent><strong>In
|
|
addition, for applications involving clinical trials</strong></p>
|
|
<p class="P_SingleIndent">Does
|
|
the design/research plan include innovative elements, as appropriate, that
|
|
enhance its sensitivity, potential for information or potential to advance
|
|
scientific knowledge or clinical practice? </p>
|
|
<div class="heading4Indent">Approach</div>
|
|
<p class=P_SingleIndent>Are the overall strategy, methodology, and analyses
|
|
well-reasoned and appropriate to accomplish the specific aims of the project? Have
|
|
the investigators included plans to address weaknesses in the rigor of prior
|
|
research that serves as the key support for the proposed project? Have the
|
|
investigators presented strategies to ensure a robust and unbiased approach, as
|
|
appropriate for the work proposed? Are potential problems, alternative
|
|
strategies, and benchmarks for success presented? If the project is in the
|
|
early stages of development, will the strategy establish feasibility and will
|
|
particularly risky aspects be managed? Have the investigators presented
|
|
adequate plans to address relevant biological variables, such as sex, for
|
|
studies in vertebrate animals or human subjects? </p>
|
|
<p class=P_SingleIndent>If the project involves human subjects and/or
|
|
NIH-defined clinical research, are the plans to address 1) the protection of
|
|
human subjects from research risks, and 2) inclusion (or exclusion) of
|
|
individuals on the basis of sex/gender, race, and ethnicity, as well as the
|
|
inclusion or exclusion of individuals of all ages (including children and older
|
|
adults), justified in terms of the scientific goals and research strategy
|
|
proposed? </p>
|
|
<p class=P_SingleIndent><strong><em>Specific to this FOA:</em></strong></p>
|
|
<p class=P_SingleIndent>Are the research strategy, methodology and analyses,
|
|
appropriate to address the intersection of sex and gender in the proposed
|
|
project?</p>
|
|
<p class=P_SingleIndent><strong>In
|
|
addition, for applications involving clinical trials</strong></p>
|
|
<p class=P_SingleIndent>Does the application adequately address the
|
|
following, if applicable</p>
|
|
<p class=P_SingleIndent><i>Study Design</i>
|
|
</p>
|
|
<p class=P_SingleIndent>Is the study design justified and appropriate to
|
|
address primary and secondary outcome variable(s)/endpoints that will be clear,
|
|
informative and relevant to the hypothesis being tested? Is the scientific
|
|
rationale/premise of the study based on previously well-designed preclinical
|
|
and/or clinical research? Given the methods used to assign participants and
|
|
deliver interventions, is the study design adequately powered to answer the
|
|
research question(s), test the proposed hypothesis/hypotheses, and provide
|
|
interpretable results? Is the trial appropriately designed to conduct the
|
|
research efficiently? Are the study populations (size, gender, age, demographic
|
|
group), proposed intervention arms/dose, and duration of the trial, appropriate
|
|
and well justified?</p>
|
|
<p class=P_SingleIndent>Are potential ethical issues adequately addressed? Is
|
|
the process for obtaining informed consent or assent appropriate? Is the
|
|
eligible population available? Are the plans for recruitment outreach,
|
|
enrollment, retention, handling dropouts, missed visits, and losses to follow-up
|
|
appropriate to ensure robust data collection? Are the planned recruitment
|
|
timelines feasible and is the plan to monitor accrual adequate? Has the need
|
|
for randomization (or not), masking (if appropriate), controls, and
|
|
inclusion/exclusion criteria been addressed? Are differences addressed, if
|
|
applicable, in the intervention effect due to sex/gender and race/ethnicity?</p>
|
|
<p class=P_SingleIndent>Are the plans to standardize, assure quality of, and
|
|
monitor adherence to, the trial protocol and data collection or distribution
|
|
guidelines appropriate? Is there a plan to obtain required study agent(s)? Does
|
|
the application propose to use existing available resources, as applicable?</p>
|
|
<p class=P_SingleIndent><i>Data Management and Statistical Analysis</i><br>
|
|
Are planned analyses and statistical approach appropriate for the proposed
|
|
study design and methods used to assign participants and deliver interventions?
|
|
Are the procedures for data management and quality control of data adequate at
|
|
clinical site(s) or at center laboratories, as applicable? Have the methods for
|
|
standardization of procedures for data management to assess the effect of the
|
|
intervention and quality control been addressed? Is there a plan to complete
|
|
data analysis within the proposed period of the award?</p>
|
|
<div class="heading4Indent">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>In
|
|
addition, for applications involving clinical trials</strong></p>
|
|
<p class="P_SingleIndent">If proposed, are the
|
|
administrative, data coordinating, enrollment and laboratory/testing centers,
|
|
appropriate for the trial proposed?</p>
|
|
<p class="P_SingleIndent">Does the application adequately
|
|
address the capability and ability to conduct the trial at the proposed site(s)
|
|
or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?</p>
|
|
<p class="P_SingleIndent">If international site(s) is/are
|
|
proposed, does the application adequately address the complexity of executing
|
|
the clinical trial?</p>
|
|
<p class="P_SingleIndent">If multi-sites/centers, is there
|
|
evidence of the ability of the individual site or center to: (1) enroll the
|
|
proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in
|
|
an accurate and timely fashion; and, (4) operate within the proposed
|
|
organizational structure? </p>
|
|
<div class="heading4">Additional Review Criteria</div>
|
|
<p>As applicable for the project proposed, reviewers will
|
|
evaluate the following additional items while determining scientific and
|
|
technical merit, and in providing an overall impact score, but will not give
|
|
separate scores for these items.</p>
|
|
<p class=heading4Indent>Study Timeline </p>
|
|
<p class=P_SingleIndent><strong>Specific
|
|
to applications involving clinical trials</strong></p>
|
|
<p class=P_SingleIndent>Is the study timeline described in detail, taking
|
|
into account start-up activities, the anticipated rate of enrollment, and
|
|
planned follow-up assessment? Is the projected timeline feasible and well
|
|
justified? Does the project incorporate efficiencies and utilize existing
|
|
resources (e.g., CTSAs, practice-based research networks, electronic medical
|
|
records, administrative database, or patient registries) to increase the
|
|
efficiency of participant enrollment and data collection, as appropriate? </p>
|
|
<p class=P_SingleIndent>Are potential challenges and corresponding solutions
|
|
discussed (e.g., strategies that can be implemented in the event of enrollment
|
|
shortfalls)?</p>
|
|
<div class="heading4Indent">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">Inclusion of Women, Minorities,
|
|
and Individuals Across the Lifespan </div>
|
|
<p class="P_SingleIndent">When the proposed project involves
|
|
human subjects and/or NIH-defined clinical research, the committee will
|
|
evaluate the proposed plans for the inclusion (or exclusion) of individuals on
|
|
the basis of sex/gender, race, and ethnicity, as well as the inclusion (or
|
|
exclusion) of individuals of all ages (including children and older adults) to
|
|
determine if it is justified in terms of the scientific goals and research
|
|
strategy proposed. For additional information on review of the Inclusion
|
|
section, please refer to the <a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11174">Guidelines for the Review of Inclusion
|
|
in Clinical Research</a>.</p>
|
|
<div class="heading4Indent">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">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">Resubmissions</div>
|
|
<p class="P_SingleIndent">For Resubmissions, the committee
|
|
will evaluate the application as now presented, taking into consideration the
|
|
responses to comments from the previous scientific review group and changes
|
|
made to the project. </p>
|
|
<div class="heading4Indent">Renewals</div>
|
|
<p class="P_SingleIndent">Not Applicable</p>
|
|
<div class="heading4Indent">Revisions</div>
|
|
<p class="P_SingleIndent">Not Applicable</p>
|
|
<div class="heading4">Additional Review Considerations</div>
|
|
<p>As applicable for the project proposed, reviewers will
|
|
consider each of the following items, but will not give scores for these items,
|
|
and should not consider them in providing an overall impact score.</p>
|
|
<div class="heading4Indent">Applications from Foreign
|
|
Organizations</div>
|
|
<p class="P_SingleIndent">Not applicable</p>
|
|
<div class="heading4Indent">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">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/url_redirect.htm?id=11153"> Genomic Data Sharing Plan (GDS)</a>. </p>
|
|
<div class="heading4Indent">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">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>Applications will be evaluated for scientific and technical
|
|
merit by an appropriate Scientific Review Group convened by the Center for
|
|
Scientific Review 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>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><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>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>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>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>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>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>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>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>Individual awards are based on the application submitted to,
|
|
and as approved by, the NIH and are subject to the IC-specific terms and
|
|
conditions identified in the NoA. </p>
|
|
<p>ClinicalTrials.gov: If an award provides for one or more
|
|
clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the
|
|
"responsible party" must register and submit results information for
|
|
certain applicable clinical trials on the ClinicalTrials.gov Protocol
|
|
Registration and Results System Information Website (<a
|
|
href="https://register.clinicaltrials.gov">https://register.clinicaltrials.gov</a>).
|
|
NIH expects registration and results reporting of all trials whether required
|
|
under the law or not. For more information, see <a
|
|
href="https://grants.nih.gov/policy/clinical-trials/reporting/index.htm">https://grants.nih.gov/policy/clinical-trials/reporting/index.htm</a> </p>
|
|
<p>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>
|
|
<p>Data and Safety Monitoring Requirements: The NIH policy for
|
|
data and safety monitoring requires oversight and monitoring of all
|
|
NIH-conducted or -supported human biomedical and behavioral intervention
|
|
studies (clinical trials) to ensure the safety of participants and the validity
|
|
and integrity of the data. Further information concerning these requirements is
|
|
found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the
|
|
application instructions (SF424 (R&R) and PHS 398). </p>
|
|
<p>Investigational New Drug or Investigational Device Exemption
|
|
Requirements: Consistent with federal regulations, clinical research projects
|
|
involving the use of investigational therapeutics, vaccines, or other medical
|
|
interventions (including licensed products and devices for a purpose other than
|
|
that for which they were licensed) in humans under a research protocol must be
|
|
performed under a Food and Drug Administration (FDA) investigational new drug
|
|
(IND) or investigational device exemption (IDE). </p>
|
|
<div class="heading3">2. Administrative and
|
|
National Policy Requirements</div>
|
|
<p>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>Recipients of federal financial
|
|
assistance (FFA) from HHS must administer their programs in compliance with
|
|
federal civil rights law. This means that recipients of HHS funds must ensure
|
|
equal access to their programs without regard to a person’s race, color,
|
|
national origin, disability, age and, in some circumstances, sex and religion.
|
|
This includes ensuring your programs are accessible to persons with limited
|
|
English proficiency. 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.</p>
|
|
<p>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. HHS provides
|
|
general 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/index.html">https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html</a>.
|
|
The HHS Office for Civil Rights also provides guidance on complying with civil
|
|
rights laws enforced by HHS. Please see <a
|
|
href="https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html">https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html</a>;
|
|
and <a
|
|
href="https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html">https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html</a>.
|
|
Recipients of FFA also have specific legal obligations for serving qualified
|
|
individuals with disabilities. Please see <a
|
|
href="https://www.hhs.gov/civil-rights/for-individuals/disability/index.html">https://www.hhs.gov/civil-rights/for-individuals/disability/index.html</a>.
|
|
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. Also note it is an HHS
|
|
Departmental goal to ensure access to quality, culturally competent care,
|
|
including long-term services and supports, for vulnerable populations. 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">http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53</a>. </p>
|
|
<p>In accordance with the statutory provisions contained in
|
|
Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal
|
|
Year 2009 (Public Law 110-417), NIH awards will be subject to 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>Not Applicable</p>
|
|
<div class="heading3">3. Reporting</div>
|
|
<p>When multiple years are involved, awardees will be required
|
|
to submit the <a href="//grants.nih.gov/grants/rppr/index.htm">Research
|
|
Performance Progress Report (RPPR)</a> annually and financial statements as
|
|
required in the <a
|
|
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11161">NIH Grants
|
|
Policy Statement.</a> </p>
|
|
<p><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>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>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>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>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>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>General Grants Information
|
|
(Questions regarding application instructions, application processes, and NIH
|
|
grant resources)<br>
|
|
Email: <a href="/cdn-cgi/l/email-protection#1a5d687b746e6953747c755a747372347d756c"><span class="__cf_email__" data-cfemail="682f1a09061c1b21060e0728060100460f071e">[email protected]</span></a> (preferred
|
|
method of contact)<br>
|
|
Telephone: 301-945-7573</p>
|
|
<p>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#5b282e2b2b34292f1b3c293a352f28753c342d"><span class="__cf_email__" data-cfemail="e695939696899492a6819487889295c8818990">[email protected]</span></a><br><br>
|
|
</p>
|
|
<div class="heading4">Scientific/Research Contact(s)</div>
|
|
<p>Rebecca DelCarmen-Wiggins, Ph.D.<br>
|
|
Office of Research on Women's Health (ORWH)<br>
|
|
Telephone: 301-451-8689 <br>
|
|
Email: <a href="/cdn-cgi/l/email-protection#d4a6b0b1b8b7b5a6b994b9b5bdb8fababdbcfab3bba2"><span class="__cf_email__" data-cfemail="2456404148474556496449454d480a4a4d4c0a434b52">[email protected]</span></a></p>
|
|
<p>Susannah Allison, Ph.D.<br>
|
|
National Institute of Mental Health (NIMH)<br>
|
|
Telephone: 240-627-386 <br>
|
|
Email: <a href="/cdn-cgi/l/email-protection#77161b1b1e0418190402371a161e1b59191e1f59101801"><span class="__cf_email__" data-cfemail="69080505001a06071a1c290408000547070001470e061f">[email protected]</span></a> </p>
|
|
<p>Christopher Barnhart, Ph.D.<br>
|
|
Sexual and Gender Minority Research Office (SGMRO)<br>
|
|
Telephone: 301-761-5262<br>
|
|
Email: <a href="/cdn-cgi/l/email-protection#e3a08b918a90978c938b8691cd8182918d8b829197a38d8a8bcd848c95"> <span class="__cf_email__" data-cfemail="713219031802051e011914035f1310031f19100305311f18195f161e07">[email protected]</span></a></p>
|
|
<p>Inna Belfer, M.D., Ph.D.<br>
|
|
National Center for Complementary and Integrative Health
|
|
(NCCIH)<br>
|
|
Telephone: 301-435-1573<br>Email: <a href="/cdn-cgi/l/email-protection#3d5453535c135f58515b584f7d535455135a524b"><span class="__cf_email__" data-cfemail="244d4a4a450a464148424156644a4d4c0a434b52">[email protected]</span></a> </p>
|
|
<p>Abee Boyles, Ph.D. <br>
|
|
National Institute of Environmental Health Sciences (NIEHS)<br>
|
|
Telephone: 984-287-3241 <br>
|
|
Email: <a href="/cdn-cgi/l/email-protection#a9c8cbcccc87cbc6d0c5ccdae9c7c0c187cec6df"><span class="__cf_email__" data-cfemail="3a5b585f5f14585543565f497a545352145d554c">[email protected]</span></a></p>
|
|
<p>Juliane Caviston, Ph.D.<br>
|
|
National Institute of Allergy and Infectious Diseases (NIAID)<br>
|
|
Telephone: 301-761-5094<br>
|
|
Email: <a href="/cdn-cgi/l/email-protection#dfb5aab3b6beb1baf1bcbea9b6acabb0b19fb1b6b7f1b8b0a9"><span class="__cf_email__" data-cfemail="0369766f6a626d662d6062756a70776c6d436d6a6b2d646c75">[email protected]</span></a></p>
|
|
<p>Preethi Chander, Ph.D.<br>
|
|
National Institute of Dental and
|
|
Craniofacial Research (NIDCR)<br>
|
|
Telephone: 301-827-4620<br>
|
|
Email: <a href="/cdn-cgi/l/email-protection#93e3e1f6f6e7fbfabdf0fbf2fdf7f6e1d3fdfafbbdf4fce5"><span class="__cf_email__" data-cfemail="addddfc8c8d9c5c483cec5ccc3c9c8dfedc3c4c583cac2db">[email protected]</span></a> </p>
|
|
<p>Dena Fischer, D.D.S., M.S.D., M.S.<br>
|
|
National Institute of Dental and
|
|
Craniofacial Research (NIDCR)<br>
|
|
Telephone: 301-594-4876<br>
|
|
Email: <a href="/cdn-cgi/l/email-protection#7410111a155a121d07171c1106341a1d1c5a131b02"><span class="__cf_email__" data-cfemail="aacecfc4cb84ccc3d9c9c2cfd8eac4c3c284cdc5dc">[email protected]</span></a> </p>
|
|
<p>Melissa Gerald, Ph.D.<br>
|
|
National Institute of Aging<br>
|
|
Telephone: 301-451-4503<br>
|
|
Email: <a href="/cdn-cgi/l/email-protection#df92bab3b6acacbef1b8baadbeb3bb9fb1b6b7f1b8b0a9"><span class="__cf_email__" data-cfemail="83cee6efeaf0f0e2ade4e6f1e2efe7c3edeaebade4ecf5">[email protected]</span></a> </p>
|
|
<p>Ivana Grakalic, Ph.D.<br>
|
|
National Institute on Alcohol Abuse
|
|
and Alcoholism (NIAAA)<br>
|
|
Telephone: 301-443-7600<br>
|
|
Email: <a href="/cdn-cgi/l/email-protection#58313f2a39333934313b183539313476363130763f372e"><span class="__cf_email__" data-cfemail="59303e2b38323835303a193438303577373031773e362f">[email protected]</span></a> </p>
|
|
<p>Holly Moore, Ph.D.<br>
|
|
National Institute on Drug Abuse
|
|
(NIDA)<br>
|
|
Telephone: 301-827-7376<br>
|
|
Email: <a href="/cdn-cgi/l/email-protection#d7bfb8bbbbaef9bab8b8a5b297b9bebff9b0b8a1"><span class="__cf_email__" data-cfemail="dfb7b0b3b3a6f1b2b0b0adba9fb1b6b7f1b8b0a9">[email protected]</span></a></p>
|
|
<p>Kelli Oster<br>
|
|
National Institute of Nursing Research (NINR)<br>
|
|
Telephone: 301-594-2177<br>
|
|
Email: <a href="/cdn-cgi/l/email-protection#59362a2d3c2b32193438303577373031773e362f"><span class="__cf_email__" data-cfemail="b1dec2c5d4c3daf1dcd0d8dd9fdfd8d99fd6dec7">[email protected]</span></a></p>
|
|
<p>Thaddeus T Schug, Ph.D.<br>
|
|
National Institute of Environmental Health Sciences (NIEHS)<br>
|
|
Telephone: 984-287-3319 <br>
|
|
Email: <a href="/cdn-cgi/l/email-protection#196a7a716c7e6d5977707c716a37777071377e766f"><span class="__cf_email__" data-cfemail="4f3c2c273a283b0f21262a273c6121262761282039">[email protected]</span></a></p>
|
|
<p>Lillian Shum, Ph.D.<br>
|
|
National Institute of Dental and Craniofacial Research
|
|
(NIDCR)<br>
|
|
Telephone: 301-594-0618 <br>
|
|
Email: <a href="/cdn-cgi/l/email-protection#2a79425f47666a474b434604444342044d455c"><span class="__cf_email__" data-cfemail="dc8fb4a9b1909cb1bdb5b0f2b2b5b4f2bbb3aa">[email protected]</span></a> </p>
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<p>Jennifer Troyer, Ph.D.<br>
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National Human Genome Research Institute (NHGRI)<br>
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Telephone: 301-480-3565 <br>
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Email: <a href="/cdn-cgi/l/email-protection#1460667b6d71667e5479757d783a7a7d7c3a737b62"><span class="__cf_email__" data-cfemail="6b1f1904120e19012b060a020745050203450c041d">[email protected]</span></a></p>
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<p>Della White, Ph.D.<br>
|
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National Center for Complementary and
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Integrative Health (NCCIH)<br>
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Telephone: 301-827-6358<br>
|
|
Email: <a href="/cdn-cgi/l/email-protection#8aeeefe6e6eba4fde2e3feefcae4e3e2a4ede5fc"><span class="__cf_email__" data-cfemail="91f5f4fdfdf0bfe6f9f8e5f4d1fff8f9bff6fee7">[email protected]</span></a> </p>
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<p>Sung Sug (Sarah) Yoon, RN, Ph.D.<br>
|
|
National Institute of Nursing Research (NINR)<br>
|
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Telephone: 301-402-6959 <br>
|
|
Email: <a href="/cdn-cgi/l/email-protection#b7c4c2d9d0c4c2d099ced8d8d9f7d9dedf99d0d8c1"><span class="__cf_email__" data-cfemail="7003051e170305175e091f1f1e301e19185e171f06">[email protected]</span></a> </p>
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<div class="heading4"> </div>
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<div class="heading4">Peer Review Contact(s)</div>
|
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<p>Elaine Sierra-Rivera, Ph.D.<br>
|
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Center for Scientific Review (CSR) <br>
|
|
Telephone: 301-435-1043<br>
|
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Email: <a href="/cdn-cgi/l/email-protection#13617a657661726076537060613d7d7a7b3d747c65"><span class="__cf_email__" data-cfemail="2f5d46594a5d4e5c4a6f4c5c5d0141464701484059">[email protected]</span></a> </p>
|
|
<div class="heading4">Financial/Grants Management Contact(s)</div>
|
|
<p>John Bladen<br>National Institute on Aging (NIA)<br>Telephone: 301-402-7730<br>Email: <a href="/cdn-cgi/l/email-protection#452f27292421202b0528242c296b2b2c2d6b222a33"><span class="__cf_email__" data-cfemail="d7bdb5bbb6b3b2b997bab6bebbf9b9bebff9b0b8a1">[email protected]</span></a> </p>
|
|
<p>Shelley Carow<br>National Center for Complementary and Integrative Health (NCCIH)<br>Telephone: 301-594-3788<br>Email: <a href="/cdn-cgi/l/email-protection#88fbebe9fae7ffc8e5e9e1e4a6e6e1e0a6efe7fe"><span class="__cf_email__" data-cfemail="483b2b293a273f082529212466262120662f273e">[email protected]</span></a> </p>
|
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<p>Pamela Fleming<br>National Institute on Drug Abuse (NIDA)<br>Telephone: 301 480 1159<br>
|
|
Email: <a href="/cdn-cgi/l/email-protection#9feff9f3faf2f6f1f8dff2fef6f3b1f1f6f7b1f8f0e9"><span class="__cf_email__" data-cfemail="f080969c959d999e97b09d91999cde9e9998de979f86">[email protected]</span></a></p>
|
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<p>Judy Fox<br>National Institute on Alcohol Abuse and Alcoholism (NIAAA)<br>Telephone: 301-443-4704<br>
|
|
Email: <a href="/cdn-cgi/l/email-protection#7218141d0a321f131b1e5c1c1b1a5c151d04"><span class="__cf_email__" data-cfemail="3258545d4a725f535b5e1c5c5b5a1c555d44">[email protected]</span></a></p>
|
|
<p>Deanna Ingersoll<br>National Human Genome Research Institute (NHGRI)<br>Telephone: 301-402-0733<br>E-mail: <a href="/cdn-cgi/l/email-protection" class="__cf_email__" data-cfemail="eb82858c8e99988487878fab868a8287c5858283c58c849d">[email protected]</a> </p>
|
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<p>Aaron Nicholas<br>National Institute of Environmental Health Sciences (NIEHS)<br>Telephone: 984-287-3297 <br>Email: <a href="/cdn-cgi/l/email-protection#27494e444f484b464667494e424f5409494e4f09404851"><span class="__cf_email__" data-cfemail="234d4a404b4c4f4242634d4a464b500d4d4a4b0d444c55">[email protected]</span></a></p>
|
|
<p>Kelli Oster<br>National Institute of Nursing Research (NINR)<br>Telephone: 301-594-2177<br> Email: <a href="/cdn-cgi/l/email-protection#2748545342554c674a464e4b09494e4f09404851"><span class="__cf_email__" data-cfemail="7619050213041d361b171f1a58181f1e58111900">[email protected]</span></a> </p>
|
|
<p>Diana Rutberg, M.B.A.<br>
|
|
National Institute of Dental and Craniofacial Research
|
|
(NIDCR)<br>
|
|
Telephone: 301-594-4798<br> Email: <a href="/cdn-cgi/l/email-protection#c5b7b0b1a7a0b7a2a185a8a4aca9ebabacadeba2aab3"><span class="__cf_email__" data-cfemail="215354554344534645614c40484d0f4f48490f464e57">[email protected]</span></a> </p>
|
|
<p>Donna Sullivan<br>
|
|
National Institute of Allergy and Infectious Diseases
|
|
(NIAID)<br>
|
|
Telephone: 240-669-2979<br>
|
|
Email: <a href="/cdn-cgi/l/email-protection#1b5f486e7777726d7a755b75727a727f35757273357c746d"><span class="__cf_email__" data-cfemail="6d293e180101041b0c032d03040c040943030405430a021b">[email protected]</span></a></p>
|
|
<p>Rita Sisco<br>
|
|
National Institute of Mental Health (NIMH)<br>
|
|
Telephone: 301-443-2805<br>
|
|
Email: <a href="/cdn-cgi/l/email-protection#b8cbd1cbdbd7caf8d5d9d1d496d6d1d096dfd7ce"><span class="__cf_email__" data-cfemail="2e5d475d4d415c6e434f47420040474600494158">[email protected]</span></a></p>
|
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<div class="heading2"><a name="_Toc258873273"></a><a
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name="_Section_VIII._Other"></a>Section VIII. Other
|
|
Information</div>
|
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<p>Recently issued trans-NIH <a
|
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href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11163">policy
|
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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>
|
|
<div class="heading4">Authority and Regulations</div>
|
|
<p>Awards are made under the authorization of Sections 301 and
|
|
405 of the Public Health Service Act as amended (42 USC 241 and 284) and under
|
|
Federal Regulations 42 CFR Part 52 and 45 CFR Part 75. </p>
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<HR>
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<A HREF="/grants/guide/WeeklyIndex.cfm?09-27-19">Weekly TOC for this Announcement</A><br>
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<A HREF="/grants/guide/index.html">NIH Funding Opportunities and Notices</A>
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<div style="float:left; padding: 5 5 5 70"> <a href="https://www.hhs.gov/"><img src="/images7/dhhs_sm.gif" width="36" height="37" border="0" alt="Department of Health and Human Services (HHS) - Home Page" long desc="Logo, circular in shape, depicting an American eagle in-flight with stylized profiles of human faces appearing on the trailing edge of the wings. The perimeter of the logo is encircled with the words 'Department of Health and Human Services U S A'"></a></div>
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<div style="padding: 5 5 5 5;">Department of Health<br>
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and Human Services (HHS)</div>
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