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<TITLE>PAR-24-231: Community Level Interventions to Improve Minority Health and Reduce Health Disparities (R01 - Clinical Trial Optional)</TITLE>
<META NAME="description" CONTENT="NIH Funding Opportunities and Notices in the NIH Guide for Grants and Contracts: Community Level Interventions to Improve Minority Health and Reduce Health Disparities (R01 - Clinical Trial Optional) PAR-24-231. NIMHD">
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<div id="page-title" class="heading1" tabindex="0">Department of Health and Human Services</div>
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<a name="_Part 1. Overview Information"></a><h1 class="heading1">Part 1. Overview Information</h1>
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<div class="row" data-index="2">
<div class="col-md-4 datalabel" tabindex="0" data-element-id="191533" data-element-required="true" data-element-has-value="true" data-section-code="OI" data-element-type="TEXT">
Participating Organization(s)
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<div class=" col-md-8 datacolumn">
<p>National Institutes of Health (<a href="http://www.nih.gov">NIH</a>)</p>
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<div class="col-md-push-4 col-md-8 datacolumn">
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Components of Participating Organizations
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<div class=" col-md-8 datacolumn">
<p>National Institute on Minority Health and Health Disparities (<a href="https://www.nimhd.nih.gov/" target="_blank" rel="noreferrer">NIMHD</a>)
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Funding Opportunity Title
</div>
<div class=" col-md-8 datacolumn">
<span class="title">Community Level Interventions to Improve Minority Health and Reduce Health Disparities (R01 - Clinical Trial Optional)</span>
</div>
</div>
<div class="row" data-index="7">
<div class="col-md-4 datalabel" tabindex="0" data-element-id="191538" data-element-required="true" data-element-has-value="true" data-section-code="OI" data-element-type="TEXT">
Activity Code
</div>
<div class=" col-md-8 datacolumn">
<p class="Normal"><a href="//grants.nih.gov/grants/funding/ac_search_results.htm?text_curr=r01&amp;Search.x=0&amp;Search.y=0&amp;Search_Type=Activity">R01</a> Research Project Grant</p>
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<div class="col-md-4 datalabel" tabindex="0" data-element-id="191539" data-element-required="true" data-element-has-value="true" data-section-code="OI" data-element-type="LINKED_ELEMENT">
Announcement Type
</div>
<div class=" col-md-8 datacolumn">
New
</div>
</div>
<div class="row" data-index="9">
<div class="col-md-4 datalabel" tabindex="0" data-element-id="191540" data-element-required="true" data-element-has-value="true" data-section-code="OI" data-element-type="TEXT">
Related Notices</div><div class="col-md-8 datacolumn">
<ul>
<li>
<strong>April 04, 2024</strong> - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice <a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-24-084.html">NOT-OD-24-084</a>
</li>
<li class="Normal"><strong>August 31, 2022</strong>- Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice&nbsp;<a href="https://grants.nih.gov/grants/guide/notice-files/not-od-22-198.html">NOT-OD-22-198</a>.</li>
<li class="Normal"><strong>August 5, 2022</strong>- Implementation Details for the NIH Data Management and Sharing Policy. See Notice&nbsp;<a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-22-189.html">NOT-OD-22-189</a>.</li>
</ul>
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Funding Opportunity Number (FON)
</div>
<div class=" col-md-8 datacolumn">
<span class="noticenum">PAR-24-231</span>
</div>
</div>
<div class="row" data-index="11">
<div class="col-md-4 datalabel" tabindex="0" data-element-id="191542" data-element-required="true" data-element-has-value="true" data-section-code="OI" data-element-type="LINKED_ELEMENT">
Companion Funding Opportunity
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<div class=" col-md-8 datacolumn">
None
</div>
</div>
<div class="row" data-index="12">
<div class="col-md-4 datalabel" tabindex="0" data-element-id="191543" data-element-required="true" data-element-has-value="true" data-section-code="OI" data-element-type="TEXT">
Number of Applications
</div>
<div class=" col-md-8 datacolumn">
<p class="Normal">See Part 2, Section III. 3. Additional Information on Eligibility.</p>
</div>
</div>
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<div class="col-md-4 datalabel" tabindex="0" data-element-id="191544" data-element-required="true" data-element-has-value="true" data-section-code="OI" data-element-type="LINKED_ELEMENT">
Assistance Listing Number(s)
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<div class=" col-md-8 datacolumn">
93.307
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Funding Opportunity Purpose
</div>
<div class=" col-md-8 datacolumn">
<p>The purpose of this initiative is to support research to develop and test community-level interventions to improve minority health and reduce health disparities.</p>
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<a name="_Key Dates"></a><h2 class="heading2">Key Dates</h2>
</div>
<div class="row" data-index="16">
<div class="col-md-4 datalabel" tabindex="0" data-element-id="191547" data-element-required="true" data-element-has-value="true" data-section-code="KD" data-element-type="DATE">
Posted Date
</div>
<div class=" col-md-8 datacolumn">
June 10, 2024
</div>
</div>
<div class="row" data-index="17">
<div class="col-md-4 datalabel" tabindex="0" data-element-id="191548" data-element-required="true" data-element-has-value="true" data-section-code="KD" data-element-type="LINKED_ELEMENT">
Open Date (Earliest Submission Date)
</div>
<div class=" col-md-8 datacolumn">
July 31, 2024
</div>
</div>
<div class="row" data-index="18">
<div class="col-md-4 datalabel" tabindex="0" data-element-id="191549" data-element-required="true" data-element-has-value="true" data-section-code="KD" data-element-type="TEXT">
Letter of Intent Due Date(s)
</div>
<div class=" col-md-8 datacolumn">
<p>30 days prior to the application due date. &nbsp;</p>
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The following table includes NIH <a href="https://grants.nih.gov/grants/how-to-apply-application-guide/due-dates-and-submission-policies/due-dates.htm" target="_blank" rel="noreferrer">standard due dates</a> marked with an asterisk.
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<th scope="col" colspan="3" style="border:2px solid #bcbcbc;" class="text-center">Application Due Dates</th>
<th scope="col" colspan="3" style="border:2px solid #bcbcbc;" class="text-center">Review and Award Cycles</th>
</tr>
<tr>
<th scope="col" style="width:16.66%;border-left:2px solid #bcbcbc;" class="text-center">New</th>
<th scope="col" style="width:16.66%" class="text-center">Renewal / Resubmission / Revision (as allowed)</th>
<th scope="col" style="width:16.66%;border-right:2px solid #bcbcbc;" class="text-center">AIDS - New/Renewal/Resubmission/Revision, as allowed</th>
<th scope="col" style="width:16.66%" class="text-center">Scientific Merit Review</th>
<th scope="col" style="width:16.66%" class="text-center">Advisory Council Review</th>
<th scope="col" style="width:16.66%;border-right:2px solid #bcbcbc;" class="text-center">Earliest Start Date</th>
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</thead>
<tbody>
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<td>
October 05, 2024 *
</td>
<td>
November 05, 2024 *
</td>
<td>
January 07, 2025 *
</td>
<td>March 2025</td>
<td> May 2025
</td>
<td>July 2025</td>
</tr>
<tr>
<td>
October 05, 2025 *
</td>
<td>
November 05, 2025 *
</td>
<td>
January 07, 2026 *
</td>
<td>March 2026</td>
<td> May 2026
</td>
<td>July 2026</td>
</tr>
<tr>
<td>
October 05, 2026 *
</td>
<td>
November 05, 2026 *
</td>
<td>
January 07, 2027 *
</td>
<td>March 2027</td>
<td> May 2027
</td>
<td>July 2027</td>
</tr>
</tbody>
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</div>
<div data-element-id="191551" data-element-has-label="false" data-element-required="false" data-element-has-value="false" data-section-code="KD" data-element-type="TEXT">
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<p class="Normal">All applications are due by 5:00 PM local time of applicant organization.&nbsp;</p>
<p class="Normal">Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.</p>
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<div class="col-md-4 datalabel" tabindex="0" data-element-id="191558" data-element-required="true" data-element-has-value="true" data-section-code="KD" data-element-type="LINKED_ELEMENT">
Expiration Date
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<div class=" col-md-8 datacolumn">
January 08, 2027
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<div class="row" data-index="28">
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Due Dates for E.O. 12372
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<p class="Normal">Not Applicable</p>
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Required Application Instructions
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<p class="Normal">It is critical that applicants follow the instructions in the Research (R) Instructions in the&nbsp;<a href="https://grants.nih.gov/grants/guide/url_redirect.php?id=82400">How to Apply - Application Guide</a>, except where instructed to do otherwise (in this NOFO or in a Notice from <a href="//grants.nih.gov/grants/guide/url_redirect.php?id=11164">NIH Guide for Grants and Contracts</a>).</p>
<p class="Normal">Conformance to all requirements (both in the <a href="https://grants.nih.gov/grants/guide/url_redirect.php?id=82400">How to Apply - Application Guide</a> and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the <a href="https://grants.nih.gov/grants/guide/url_redirect.php?id=82400">How to Apply - Application Guide</a> as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the <a href="https://grants.nih.gov/grants/guide/url_redirect.php?id=82400">How to Apply - Application Guide</a>, follow the program-specific instructions.</p>
<p class="Normal"><strong>Applications that do not comply with these instructions may be delayed or not accepted for review.</strong></p>
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<p>There are several options available to submit your application through Grants.gov to NIH and
Department of Health and Human Services partners. You <b>must</b> use one of these submission
options to access the application forms for this opportunity.</p>
<ol>
<li>Use the NIH ASSIST system to prepare, submit and track your application online.
<form action="https://public.era.nih.gov/assist" method="post" target="new">
<input type="submit" value="Apply Online Using ASSIST" name="button" class="assist_button" />
</form>
</li>
<li>Use an institutional system-to-system (S2S) solution to prepare and submit your application
to Grants.gov and <a href="https://public.era.nih.gov/commons/">eRA Commons</a> to track your
application. Check with your institutional officials regarding availability. <br /><br /></li>
<li>Use <a href="https://grants.gov/search-grants?oppStatuses=closed|archived|posted|forecasted&fon=PAR-24-231" target="_new">Grants.gov</a>
Workspace to prepare and submit your application and
<a href="http://public.era.nih.gov/commons/">eRA Commons</a> to track your application.</li>
<br /><br />
<div class="heading1" tabindex="0">Table of Contents</div>
<div class="toc-link"><a href="#_Part 1. Overview Information">Part 1. Overview Information</a></div><div class="toc-link P_SingleIndent"><a href="#_Key Dates">Key Dates</a></div><div class="toc-link"><a href="#_Part 2. Full Text of Announcement">Part 2. Full Text of Announcement</a></div><div class="toc-link P_SingleIndent"><a href="#_Section I. Notice of Funding Opportunity Description">Section I. Notice of Funding Opportunity Description</a></div><div class="toc-link P_SingleIndent"><a href="#_Section II. Award Information">Section II. Award Information</a></div><div class="toc-link P_SingleIndent"><a href="#_Section III. Eligibility Information">Section III. Eligibility Information</a></div><div class="toc-link P_SingleIndent"><a href="#_Section IV. Application and Submission Information">Section IV. Application and Submission Information</a></div><div class="toc-link P_SingleIndent"><a href="#_Section V. Application Review Information">Section V. Application Review Information</a></div><div class="toc-link P_SingleIndent"><a href="#_Section VI. Award Administration Information">Section VI. Award Administration Information</a></div><div class="toc-link P_SingleIndent"><a href="#_Section VII. Agency Contacts">Section VII. Agency Contacts</a></div><div class="toc-link P_SingleIndent"><a href="#_Section VIII. Other Information">Section VIII. Other Information</a></div>
</div><br/>
<div data-element-id="191562" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="FOD" data-element-type="TEXT">
<a name="_Part 2. Full Text of Announcement"></a><h1 class="heading1">Part 2. Full Text of Announcement</h1>
</div>
<div data-element-id="191563" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="FOD" data-element-type="TEXT">
<a name="_Section I. Notice of Funding Opportunity Description"></a><h2 class="heading2">Section I. Notice of Funding Opportunity Description</h2>
</div>
<div data-element-id="191564" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="FOD" data-element-type="TEXT">
<p><strong>Background</strong></p><p>This initiative represents the next iteration of the NIMHD Community-Based Participatory Research (CBPR) program that was established in 2005. As CBPR methodologies and other forms of community-engaged research approaches have become more common in NIH- and NIMHD-funded projects, the need to have an initiative focused on the CBPR approach rather than specific research questions or topic areas has decreased. Instead, this initiative will emphasize research priorities that can be addressed through community-engaged research approaches and that utilize the&nbsp;<a href="https://www.nimhd.nih.gov/about/overview/research-framework/nimhd-framework.html">NIMHD Research Framework</a> to assess and intervene on health determinants beyond the individual level, at the interpersonal, family, organizational, neighborhood, community, and societal levels. Recommendations generated from the NIMHD Science Visioning process indicated the need for a shift from individual-level and researcher-derived interventions to more community-derived, structural, multi-level, and multi-sectoral interventions to improve minority health effectively and sustainably and reduce and ultimately eliminate health disparities. Community-level interventions, in which interventions target determinants associated with the overall community, such as physical, built, or sociocultural environments; resources; or functioning, address many of these identified priorities, and by necessity, require community engagement to develop and/or evaluate them.</p><p><strong>Key Definitions for the NOFO:</strong></p><p><strong>Community</strong>: A social group of any size whose members reside in a specific locality, share government, and often have a common cultural and historical heritage (<a href="file://nihfiler/alvidrezjl.$/community%20interventions%20concept/Dictionary.com">Dictionary.com</a>). Communities may be self-defined (e.g., the LGBTQ+ community in a city or county) or defined by the catchment area of local government or service providers (e.g., residents served by a county school district or community clinic). Examples of communities include but are not limited to neighborhoods, towns, cities, counties, school districts, reservations or tribal communities, military bases, or college campuses. Virtual or other communities that do not reside in the same geographic location are not included for this initiative.</p><p><strong>Community-level intervention</strong>: An intervention that modifies community characteristics, including the physical or social environment; laws, policies, or practices of organizations or governmental agencies within the community; and/or norms or collective behaviors of community residents. Interventions that are delivered in community settings and/or use community-based outreach or enrollment but do not target community-level determinants of health are not considered community- level interventions. Similarly, exclusive individual-level interventions that help individuals cope with or manage the consequences of community-level determinants rather than intervening to change the community-level determinants, are not considered community-level interventions. Individual-level interventions may well be a component of a community-level intervention.</p><p><strong>Community-engaged research</strong>: The process of working collaboratively with groups of people affiliated by geographic proximity, special interests, or similar situations with respect to issues affecting their well-being (Centers for Disease Control and Prevention). Community-engaged research is that which emphasizes collaborative partnerships with key stakeholders such as community partners, leaders, and knowledge holders, and leverages community resources to achieve community benefit via the research process. Approaches to community engagement include participatory action research, community-based participatory research, team science, empowerment evaluation approaches, community asset mapping, and citizen science.</p><p><strong>Populations with health disparities</strong>:<i>&nbsp;</i>Populations defined in section 464z-3(d)(1) of the Public Health Service Act, 42 U.S.C. 285t(d)(1) as &#147;health disparity populations&#148; based on higher overall rates of disease incidence, prevalence, morbidity, mortality, or survival rates in the population as compared to the health status of the general population. NIH-designated U.S. health disparity populations currently include Blacks/African Americans, Hispanics/Latinos, American Indians/Alaska Natives, Asian Americans, Native Hawaiians and Pacific Islanders, Middle Eastern/North Africans, socioeconomically disadvantaged populations, underserved rural populations, &nbsp;sexual and gender minorities, and individuals with disabilities.</p><p><strong>Research Objectives</strong></p><p>This initiative will support research projects to develop and test prospective community-level interventions to improve minority health and decrease health disparities. Community-level intervention projects are expected to have the following features:</p><ul><li>Are led by or conducted in full partnership with appropriate community partners, such as community-based organizations, faith-based organizations, local businesses, neighborhood associations, labor unions, patient or consumer advocacy groups, public health departments, healthcare systems, school systems, law enforcement or criminal justice agencies, social service agencies, or departments of commerce, labor, transportation, housing, recreation. Multi-sectoral collaborations involving partnerships with multiple types of organizations in the public and private sector are strongly encouraged.</li><li>Are focused on improving health outcomes or reducing health disparities in one or more NIH-designated health disparity populations in the US.</li><li>Are focused on the entire population in communities (e.g., an intervention to increase the availability of fresh produce or walkable green spaces) or a specific population within communities (e.g., an intervention to improve physical activity among high school students or older adults within the community).</li><li>Are guided by a conceptual model identifying hypothesized pathways between the community-level intervention, community-level determinants, and health outcomes.</li><li>Collect or obtain data beyond individual self-report to determine how the intervention is impacting community-level determinants of health.</li><li>Are supported by relevant preliminary data. It is not required for the community-level intervention to have been pilot tested in multiple communities.</li><li>Prospectively test the impact of interventions on self-reported or measured health outcomes. Retrospective analysis of existing or past community-level interventions or initiatives are not responsive to this initiative.</li><li>Include health outcomes at the individual, interpersonal/organizational, or community level, or a combination.</li><li>Use appropriate measures and analytic methods appropriate for examining community-level mechanisms of action and health outcomes.</li><li>Test interventions that have the potential to be sustainable in the community after project funding is over.</li></ul><p>Investigators who wish to evaluate the effect of an intervention on a health-related biomedical or behavioral outcome are strongly encouraged to use appropriate intervention study designs, such as a parallel group- or cluster-randomized trial, a stepped-wedge group- or cluster randomized trial, a rigorous quasi-experimental design such as a group- or cluster-level regression discontinuity design or an interrupted time-series design, or a rigorous alternative. Intervention designs that lack comparison conditions or sites (e.g., an intervention implemented in a single clinic or neighborhood) are strongly discouraged. Whenever participants are assigned to study arms in groups or clusters (e.g., families, clinics, schools, worksites, communities, counties, states) and observations taken on individual participants are analyzed for intervention effects, special methods are required for analysis and sample size. Methods consistent with plans for assignment of participants and delivery of interventions should be documented in the application. Additional information is available at&nbsp;<a href="https://researchmethodsresources.nih.gov/"><i>https://researchmethodsresources.nih.gov/</i></a>.</p><p><strong>Specific Areas of Research Interest</strong></p><p>Community-level intervention targets of special interest include but are not limited to the following:</p><ul><li>Increasing affordable healthy food options and opportunities for physical activity outside the home.</li><li>Changing community norms and reducing structural barriers related to health promoting behaviors, such as breastfeeding, vaccination, physical activity, and preventive health screening.</li><li>Improving community attitudes (e.g., reducing prejudice, stigma, or discrimination) towards sociodemographic groups (e.g., racial/ethnic minorities, sexual and gender minorities) or towards individuals with certain health conditions (e.g., HIV, mental illness) that are detrimental to the health and well-being of these populations.</li><li>Promoting screening, detection, help-seeking, and self-management related to acute or chronic illnesses (e.g., COVID-19, cancer, HIV, stroke, diabetes, cardiovascular disease, depression, substance use disorders).</li><li>Enhancing the ability of community-dwelling older adults to age in place or individuals with disabilities to live independently and maintain health and well-being.</li><li>Promoting community re-integration and health of individuals returning to the community after incarceration or institutionalization.</li><li>Promoting healthy transition of individuals returning to the community after acute or chronic hospitalization.</li><li>Preventing accidental injury, interpersonal violence, or suicide and suicide thoughts and behaviors especially with use of firearms.</li></ul><p>NIMHD also encourages the use of standardized measures for conducting health disparities research such as the PhenX tool kit. Investigators involved in human-subject studies are strongly encouraged to employ a common set of tools and resources that will promote the collection of comparable data on SDOH across studies. In particular, studies with human participants should incorporate SDOH measures from the Core and Specialty collections that are available in the Social Determinants of Health Collection of the PhenX Toolkit (<a href="http://www.phenxtoolkit.org/" Title="Link to Non-U.S. Government Site">www.phenxtoolkit.org</a>).</p><p><strong>Applications Not Responsive to the NOFO</strong></p><ul><li>Projects without a focus on one or more NIH-designated populations experiencing health disparities in the US.</li><li>Projects that do not test a prospective community-level intervention.</li><li>Projects that only use individual-level data.</li><li>Projects that are individual-level randomized clinical trials.</li><li>Projects that do not involve one or more community partners, as indicated by inclusion of representatives of community organizations as compensated key personnel.</li></ul><p><i><strong>Non-responsive applications will not be reviewed</strong></i>. Applicants are strongly encouraged to reach out to the relevant scientific contact(s) to discuss whether their applications are responsive.</p>
</div>
<div data-element-id="191565" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="FOD" data-element-type="TEXT">
<p class="Normal">See <a href="#_Section_VIII._Other">Section VIII. Other Information</a> for award authorities and regulations.</p>
</div>
<div data-element-id="191566" data-element-has-label="false" data-element-required="false" data-element-has-value="true" data-section-code="FOD" data-element-type="TEXT">
<p class="Normal">Investigators proposing NIH-defined clinical trials may refer to the <a href="https://researchmethodsresources.nih.gov/">Research Methods Resources</a> website for information about developing statistical methods and study designs.</p>
</div>
<div data-element-id="191567" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="AI" data-element-type="TEXT">
<a name="_Section II. Award Information"></a><h2 class="heading2">Section II. Award Information</h2>
</div>
<div class="row" data-index="37">
<div class="col-md-4 datalabel" tabindex="0" data-element-id="191568" data-element-required="true" data-element-has-value="true" data-section-code="AI" data-element-type="TEXT">
Funding Instrument
</div>
<div class=" col-md-8 datacolumn">
<p class="Normal">Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.</p>
</div>
</div>
<div class="row" data-index="38">
<div class="col-md-4 datalabel" tabindex="0" data-element-id="191569" data-element-required="true" data-element-has-value="true" data-section-code="AI" data-element-type="LINKED_ELEMENT">
Application Types Allowed
</div>
<div class=" col-md-8 datacolumn">
New
<br>
Resubmission
<br>
</div>
</div>
<div class="row" data-index="40">
<div class="col-md-push-4 col-md-8 datacolumn">
<p class="Normal">The&nbsp;<a href="//grants.nih.gov/grants/guide/url_redirect.php?id=11116">OER Glossary</a>&nbsp;and the <a href="https://grants.nih.gov/grants/guide/url_redirect.php?id=82400">How to Apply - Application Guide</a> provide details on these application types. Only those application types listed here are allowed for this NOFO.</p>
</div>
</div>
<div class="row" data-index="41">
<div class="col-md-4 datalabel" tabindex="0" data-element-id="191572" data-element-required="false" data-element-has-value="true" data-section-code="AI" data-element-type="TEXT">
Clinical Trial?
</div>
<div class=" col-md-8 datacolumn">
<p class="Normal">Optional: Accepting applications that either propose or do not propose clinical trial(s).</p>
</div>
</div>
<div class="row" data-index="42">
<div class="col-md-push-4 col-md-8 datacolumn">
<p class="Normal"><a href="https://grants.nih.gov/grants/guide/url_redirect.php?id=82370">Need help determining whether you are doing a clinical trial?</a></p>
</div>
</div>
<div class="row" data-index="43">
<div class="col-md-4 datalabel" tabindex="0" data-element-id="191574" data-element-required="true" data-element-has-value="true" data-section-code="AI" data-element-type="TEXT">
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>
</div>
</div>
<div class="row" data-index="44">
<div class="col-md-4 datalabel" tabindex="0" data-element-id="191575" data-element-required="true" data-element-has-value="true" data-section-code="AI" data-element-type="TEXT">
Award Budget
</div>
<div class=" col-md-8 datacolumn">
<p>Application budgets are limited to $1,000,000 direct costs annually, not including Consortium F&amp;A costs.&nbsp;</p>
</div>
</div>
<div class="row" data-index="45">
<div class="col-md-4 datalabel" tabindex="0" data-element-id="191576" data-element-required="true" data-element-has-value="true" data-section-code="AI" data-element-type="TEXT">
Award Project Period
</div>
<div class=" col-md-8 datacolumn">
<p>The scope of the proposed project should determine the project period. The maximum project period is 5 years.</p>
</div>
</div>
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<p class="Normal">NIH grants policies as described in the <a href="//grants.nih.gov/grants/guide/url_redirect.php?id=11120">NIH Grants Policy Statement</a> will apply to the applications submitted and awards made from this NOFO.</p>
</div>
<div data-element-id="191578" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="EI" data-element-type="TEXT">
<a name="_Section III. Eligibility Information"></a><h2 class="heading2">Section III. Eligibility Information</h2>
</div>
<div data-element-id="191579" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="EI" data-element-type="TEXT">
<p class="heading4">1. Eligible Applicants</p>
</div>
<div class="heading4" tabindex="0" data-element-id="191580" data-element-required="true" data-element-has-value="true" data-section-code="EI" data-element-type="TEXT">
Eligible Organizations
</div>
<div data-element-id="191580" data-element-has-label="true" data-element-required="true" data-element-has-value="true" data-section-code="EI" data-element-type="TEXT">
<p class="Normal">Higher Education Institutions</p>
<ul>
<li class="Normal">Public/State Controlled Institutions of Higher Education</li>
<li class="Normal">Private Institutions of Higher Education</li>
</ul>
<p class="Normal" style="margin-left: 25px;">The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:</p>
<ul style="margin-left:25px;">
<li class="Normal">Hispanic-serving Institutions</li>
<li class="Normal">Historically Black Colleges and Universities (HBCUs)</li>
<li class="Normal">Tribally Controlled Colleges and Universities (TCCUs)</li>
<li class="Normal">Alaska Native and Native Hawaiian Serving Institutions</li>
<li class="Normal">Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)</li>
</ul>
<p class="Normal">Nonprofits Other Than Institutions of Higher Education</p>
<ul>
<li class="Normal">Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)</li>
<li class="Normal">Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)</li>
</ul>
<p class="Normal">For-Profit Organizations</p>
<ul>
<li class="Normal">Small Businesses</li>
<li class="Normal">For-Profit Organizations (Other than Small Businesses)</li>
</ul>
<p class="Normal">Local Governments</p>
<ul>
<li class="Normal">State Governments</li>
<li class="Normal">County Governments</li>
<li class="Normal">City or Township Governments</li>
<li class="Normal">Special District Governments</li>
<li class="Normal">Indian/Native American Tribal Governments (Federally Recognized)</li>
<li class="Normal">Indian/Native American Tribal Governments (Other than Federally Recognized)</li>
</ul>
</div>
<div data-element-id="191581" data-element-has-label="false" data-element-required="false" data-element-has-value="true" data-section-code="EI" data-element-type="TEXT">
<p>Federal Governments</p><ul><li>U.S. Territory or Possession</li></ul>
</div>
<div data-element-id="191582" data-element-has-label="false" data-element-required="false" data-element-has-value="true" data-section-code="EI" data-element-type="TEXT">
<p class="Normal">Other</p>
<ul>
<li class="Normal">Independent School Districts</li>
<li class="Normal">Public Housing Authorities/Indian Housing Authorities</li>
<li class="Normal">Native American Tribal Organizations (other than Federally recognized tribal governments)</li>
<li class="Normal">Faith-based or Community-based Organizations</li>
<li class="Normal">Regional Organizations</li>
</ul>
</div>
<div data-element-id="191583" data-element-has-label="false" data-element-required="false" data-element-has-value="false" data-section-code="EI" data-element-type="TEXT">
</div>
<div class="heading4" tabindex="0" data-element-id="191584" data-element-required="true" data-element-has-value="false" data-section-code="EI" data-element-type="TEXT">
Foreign Organizations
</div>
<div data-element-id="191584" data-element-has-label="true" data-element-required="true" data-element-has-value="false" data-section-code="EI" data-element-type="TEXT">
</div>
<div data-element-id="191585" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="EI" data-element-type="RADIO_BUTTON">
<p class="Normal">Non-domestic (non-U.S.) Entities (Foreign Organizations) <strong>are not</strong> eligible to apply.</p>
</div>
<div data-element-id="191586" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="EI" data-element-type="RADIO_BUTTON">
<p>Non-domestic (non-U.S.) components of U.S. Organizations <strong>are not</strong> eligible to apply.</p>
</div>
<div data-element-id="191587" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="EI" data-element-type="RADIO_BUTTON">
<p>Foreign components, as <a href="//grants.nih.gov/grants/guide/url_redirect.php?id=11118">defined in the <em>NIH Grants Policy Statement</em></a>, <strong>are not</strong> allowed.&#160;</p>
</div>
<div class="heading4" tabindex="0" data-element-id="191588" data-element-required="true" data-element-has-value="true" data-section-code="EI" data-element-type="TEXT">
Required Registrations
</div>
<div data-element-id="191588" data-element-has-label="true" data-element-required="true" data-element-has-value="true" data-section-code="EI" data-element-type="TEXT">
<p class="Normal"><strong>Applicant Organizations</strong></p>
<p class="Normal">Applicant organizations must complete and maintain the following registrations as described in the <a href="https://grants.nih.gov/grants/guide/url_redirect.php?id=82400">How to Apply - Application Guide</a> to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference <a href="//grants.nih.gov/grants/guide/url_redirect.php?id=82423">NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications</a> for additional information</p>
<ul>
<li class="Normal"><a href="https://grants.nih.gov/grants/guide/url_redirect.php?id=82390">System for Award Management (SAM) &ndash;</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.
<ul>
<li class="Normal"><a href="//grants.nih.gov/grants/guide/url_redirect.php?id=11176">NATO Commercial and Government Entity (NCAGE) Code</a> &ndash; Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.</li>
<li class="Normal">Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.</li>
</ul>
</li>
<li class="Normal"><a href="https://grants.nih.gov/grants/guide/url_redirect.php?id=11123">eRA Commons</a> - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their&nbsp;Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.</li>
<li class="Normal"><a href="//grants.nih.gov/grants/guide/url_redirect.php?id=82300">Grants.gov</a> &ndash; Applicants must have an active SAM registration in order to complete the Grants.gov registration.</li>
</ul>
<p class="Normal"><strong>Program Directors/Principal Investigators (PD(s)/PI(s))</strong></p>
<p class="Normal">All PD(s)/PI(s) must have an eRA Commons account. &nbsp;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>
<div class="heading4" tabindex="0" data-element-id="191589" data-element-required="true" data-element-has-value="true" data-section-code="EI" data-element-type="TEXT">
Eligible Individuals (Program Director/Principal Investigator)
</div>
<div data-element-id="191589" data-element-has-label="true" data-element-required="true" data-element-has-value="true" data-section-code="EI" data-element-type="TEXT">
<p class="Normal">Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support. </p>
<p class="Normal">For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the <a href="https://grants.nih.gov/grants/guide/url_redirect.php?id=82400">How to Apply - Application Guide</a>.</p>
</div>
<div data-element-id="191590" data-element-has-label="false" data-element-required="false" data-element-has-value="false" data-section-code="EI" data-element-type="TEXT">
</div>
<div data-element-id="191591" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="EI" data-element-type="TEXT">
<p class="heading4">2. Cost Sharing</p>
<p class="Normal">This NOFO does not require cost sharing as defined in the <a href="//grants.nih.gov/grants/guide/url_redirect.php?id=11126">NIH Grants Policy Statement NIH Grants Policy Statement Section 1.2 Definition of Terms.</a></p>
</div>
<div data-element-id="191592" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="EI" data-element-type="TEXT">
<p class="heading4">3. Additional Information on Eligibility</p>
<p class="heading4">Number of Applications</p>
</div>
<div data-element-id="191593" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="EI" data-element-type="TEXT">
<p class="Normal">Applicant organizations may submit more than one application, provided that each application is scientifically distinct.</p>
<p class="Normal">The NIH will not accept duplicate or highly overlapping applications under review at the same time, per <a href="//grants.nih.gov/grants/guide/url_redirect.php?id=82415">NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application</a>. This means that the NIH will not accept:</p>
<ul>
<li class="Normal">A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.</li>
<li class="Normal">A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.</li>
<li class="Normal">An application that has substantial overlap with another application pending appeal of initial peer review (see&nbsp;<a href="//grants.nih.gov/grants/guide/url_redirect.php?id=82423">NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications</a>).</li>
</ul>
</div>
<div data-element-id="191594" data-element-has-label="false" data-element-required="false" data-element-has-value="false" data-section-code="EI" data-element-type="TEXT">
</div>
<div data-element-id="191595" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT">
<a name="_Section IV. Application and Submission Information"></a><h2 class="heading2">Section IV. Application and Submission Information</h2>
</div>
<div data-element-id="191596" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT">
<p class="heading4">1. Requesting an Application Package</p>
<p class="Normal">The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in <a href="#_Required_Application_Instructions">Part 1</a> of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.</p>
</div>
<div data-element-id="191597" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT">
<p class="heading4">2. Content and Form of Application Submission</p>
<p class="Normal">It is critical that applicants follow the instructions in the Research (R) Instructions in the&nbsp;<a href="https://grants.nih.gov/grants/guide/url_redirect.php?id=82400">How to Apply - Application Guide</a>&nbsp;except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the <a href="https://grants.nih.gov/grants/guide/url_redirect.php?id=82400">How to Apply - Application Guide</a> is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.</p>
</div>
<div data-element-id="191598" data-element-has-label="false" data-element-required="false" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT">
<h4>Letter of Intent</h4><p>Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.</p><p>By the date listed in <a href="#_Part_1._Overview">Part 1. Overview Information</a>, prospective applicants are asked to submit a letter of intent that includes the following information:</p><ul><li>Descriptive title of proposed activity</li><li>Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)</li><li>Names of other key personnel</li><li>Participating institution(s)</li><li>Number and title of this funding opportunity</li></ul><p>The letter of intent should be sent to:</p><p>Crystal L. Barksdale, PhD, MPH<br> National Institute on Minority Health and Health Disparities (NIMHD)</span><br> Telephone: 301-827-4228</span><br> Email: </span><a href="/cdn-cgi/l/email-protection#e18293989295808dcf8380938a9285808d84a18f8889cf868e97"><span class="__cf_email__" data-cfemail="0a697873797e6b6624686b7861796e6b666f4a646362246d657c">[email&#160;protected]</span></a>&nbsp;</p>
</div>
<div data-element-id="191599" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT">
<p class="heading4">Page Limitations</p>
<p class="Normal">All page limitations described in the <a href="https://grants.nih.gov/grants/guide/url_redirect.php?id=82400">How to Apply &ndash; Application Guide</a> and the <a href="https://grants.nih.gov/grants/guide/url_redirect.php?id=61134">Table of Page Limits</a> must be followed.</p>
</div>
<div data-element-id="191600" data-element-has-label="false" data-element-required="false" data-element-has-value="false" data-section-code="ASI" data-element-type="TEXT">
</div>
<div class="heading4" tabindex="0" data-element-id="191601" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT">
Instructions for Application Submission
</div>
<div data-element-id="191601" data-element-has-label="true" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT">
<p class="Normal">The following section supplements the instructions found in the <a href="https://grants.nih.gov/grants/guide/url_redirect.php?id=82400">How to Apply &ndash; Application Guide</a> and should be used for preparing an application to this NOFO.</p>
</div>
<div data-element-id="191602" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT">
<p class="heading4">SF424(R&amp;R) Cover</p>
<p class="Normal">All instructions in the <a href="https://grants.nih.gov/grants/guide/url_redirect.php?id=82400">How to Apply - Application Guide</a> must be followed.</p>
</div>
<div data-element-id="191604" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT">
<p class="heading4">SF424(R&amp;R) Project/Performance Site Locations</p>
<p class="Normal">All instructions in the <a href="https://grants.nih.gov/grants/guide/url_redirect.php?id=82400">How to Apply - Application Guide</a> must be followed.</p>
</div>
<div data-element-id="191606" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT">
<p class="heading4">SF424(R&amp;R) Other Project Information</p>
<p class="Normal">All instructions in the <a href="https://grants.nih.gov/grants/guide/url_redirect.php?id=82400">How to Apply - Application Guide</a> must be followed.</p>
</div>
<div data-element-id="191607" data-element-has-label="false" data-element-required="false" data-element-has-value="false" data-section-code="ASI" data-element-type="TEXT">
</div>
<div data-element-id="191608" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT">
<p class="heading4">SF424(R&amp;R) Senior/Key Person Profile</p>
<p class="Normal">All instructions in the <a href="https://grants.nih.gov/grants/guide/url_redirect.php?id=82400">How to Apply - Application Guide</a> must be followed.</p>
</div>
<div data-element-id="191610" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT">
<p class="heading4">R&amp;R or Modular Budget</p>
<p class="Normal">All instructions in the <a href="https://grants.nih.gov/grants/guide/url_redirect.php?id=82400">How to Apply - Application Guide</a> must be followed.</p>
</div>
<div data-element-id="191612" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT">
<p class="heading4">R&amp;R Subaward Budget</p>
<p class="Normal">All instructions in the <a href="https://grants.nih.gov/grants/guide/url_redirect.php?id=82400">How to Apply - Application Guide</a> must be followed.</p>
</div>
<div data-element-id="191614" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT">
<p class="heading4">PHS 398 Cover Page Supplement</p>
<p class="Normal">All instructions in the <a href="https://grants.nih.gov/grants/guide/url_redirect.php?id=82400">How to Apply - Application Guide</a> must be followed.</p>
</div>
<div data-element-id="191616" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT">
<p class="heading4">PHS 398 Research Plan</p>
<p class="Normal">All instructions in the&nbsp;<a href="https://grants.nih.gov/grants/guide/url_redirect.php?id=82400">How to Apply - Application Guide</a> must be followed, with the following additional instructions:</p>
</div>
<div data-element-id="191617" data-element-has-label="false" data-element-required="false" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT">
<p><strong>Research Strategy:</strong> Identify and describe the communities of focus, including the populations experiencing health disparities that will be included. Provide a justification of how the intervention constitutes a community-level intervention. Provide a conceptual model that describes hypothesized causal pathways between the community-level intervention, community-level determinants, and health outcomes. Describe data sources that will be used to assess changes in community-level determinants. Provide a data analytic plan that specifies how community-level and/or multi-level intervention effects and interactions or outcomes will be handled, as appropriate. Describe and specify the roles of community partners. Describe the potential of the intervention to be sustainable in the community after the project is over and scalable to other communities.</p><p><strong>Letters of support:&nbsp;</strong>Provide letters from community collaborators and/or community leaders indicating endorsement of the community intervention(s) proposed, as well as any arrangements regarding involvement of personnel, or use of data, resources, or facilities of community-based organizations.</p>
</div>
<div data-element-id="191618" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT">
<p class="Normal"><strong>Resource Sharing Plan</strong>:&nbsp;Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the&nbsp;<a href="https://grants.nih.gov/grants/guide/url_redirect.php?id=82400">How to Apply - Application Guide</a>.</p>
</div>
<div data-element-id="191619" data-element-has-label="false" data-element-required="false" data-element-has-value="false" data-section-code="ASI" data-element-type="TEXT">
</div>
<div data-element-id="191620" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT">
<p class="Normal"><strong>Other Plan(s):&nbsp;</strong>Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.</p>
<p class="Normal">All instructions in the <a href="https://grants.nih.gov/grants/guide/url_redirect.php?id=82400">How to Apply - Application Guide</a> must be followed, with the following additional instructions:</p>
</div>
<div data-element-id="191621" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT">
<ul><li>All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.&nbsp;&nbsp;</li></ul>
</div>
<div data-element-id="191622" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT">
<p><strong>Appendix:</strong>&nbsp;Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the <a href="https://grants.nih.gov/grants/guide/url_redirect.php?id=82400">How to Apply - Application Guide</a>.</p><ul><li>No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.</li></ul>
</div>
<div data-element-id="191623" data-element-has-label="false" data-element-required="false" data-element-has-value="false" data-section-code="ASI" data-element-type="TEXT">
</div>
<div data-element-id="191624" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT">
<p class="heading4">PHS Human Subjects and Clinical Trials Information</p>
<p class="Normal">When involving human subjects research, clinical research, and/or NIH-defined&nbsp;clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the <a href="https://grants.nih.gov/grants/guide/url_redirect.php?id=82400">How to Apply - Application Guide</a>, with the following additional instructions:</p>
<p class="Normal">If you answered &#147;Yes&#148; to the question &#147;Are Human Subjects Involved?&#148; on the R&amp;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 class="Normal"><strong>Study Record: PHS Human Subjects and Clinical Trials Information</strong></p>
<p class="Normal">All instructions in the <a href="https://grants.nih.gov/grants/guide/url_redirect.php?id=82400">How to Apply - Application Guide</a> must be followed.</p>
</div>
<div data-element-id="191625" data-element-has-label="false" data-element-required="false" data-element-has-value="false" data-section-code="ASI" data-element-type="TEXT">
</div>
<div data-element-id="191626" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT">
<p class="Normal"><strong>Delayed Onset Study</strong></p>
<p class="Normal">Note: <a href="https://grants.nih.gov/grants/glossary.htm#DelayedOnsetStudy">Delayed onset</a> does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the <a href="https://grants.nih.gov/grants/guide/url_redirect.php?id=82400">How to Apply - Application Guide</a> must be followed.</p>
</div>
<div data-element-id="191627" data-element-has-label="false" data-element-required="false" data-element-has-value="false" data-section-code="ASI" data-element-type="TEXT">
</div>
<div data-element-id="191628" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT">
<p class="heading4">PHS Assignment Request Form</p>
<p class="Normal">All instructions in the <a href="https://grants.nih.gov/grants/guide/url_redirect.php?id=82400">How to Apply - Application Guide</a> must be followed.</p>
</div>
<div data-element-id="191631" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT">
<p class="heading4">3. Unique Entity Identifier and System for Award Management (SAM)</p>
<p class="Normal">See Part 2. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov</p>
</div>
<div data-element-id="191632" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT">
<p class="heading4">4. Submission Dates and Times</p>
<p class="Normal"><a href="#_Part_1._Overview">Part I.</a>&nbsp;contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or <a href="https://grants.nih.gov/grants/guide/url_redirect.php?id=82380">Federal holiday</a>, the application deadline is automatically extended to the next business day.</p>
<p class="Normal">Organizations must submit applications to <a href="//grants.nih.gov/grants/guide/url_redirect.php?id=11128" target="_blank">Grants.gov</a> (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the <a href="//grants.nih.gov/grants/guide/url_redirect.php?id=11123" target="_blank">eRA Commons</a>, NIH&#146;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. &nbsp;If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the <a href="//grants.nih.gov/grants/guide/url_redirect.php?id=82423">NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications</a>.</p>
<p class="Normal"><strong>Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.</strong></p>
<p class="Normal">Information on the submission process and a definition of on-time submission are provided in the <a href="https://grants.nih.gov/grants/guide/url_redirect.php?id=82400">How to Apply &ndash; Application Guide</a>.</p>
</div>
<div data-element-id="191633" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT">
<p class="heading4">5. Intergovernmental Review (E.O. 12372)</p>
<p class="Normal">This initiative is not subject to <a href="https://grants.nih.gov/grants/policy/nihgps/html5/section_10/10.10.1_executive_orders.htm">intergovernmental review.</a></p>
</div>
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</div>
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<p class="heading4">6. Funding Restrictions</p>
<p class="Normal">All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the <a href="//grants.nih.gov/grants/guide/url_redirect.php?id=11120">NIH Grants Policy Statement</a>.</p>
<p class="Normal">Pre-award costs are allowable only as described in the <a href="//grants.nih.gov/grants/guide/url_redirect.php?id=11143">NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost</a>.</p>
</div>
<div data-element-id="191636" data-element-has-label="false" data-element-required="false" data-element-has-value="false" data-section-code="ASI" data-element-type="TEXT">
</div>
<div data-element-id="191637" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT">
<p class="heading4">7. Other Submission Requirements and Information</p>
<p class="Normal">Applications must be submitted electronically following the instructions described in the <a href="https://grants.nih.gov/grants/guide/url_redirect.php?id=82400">How to Apply - Application Guide</a>. Paper applications will not be accepted.</p>
<p class="Normal">Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.</p>
<p class="Normal">For assistance with your electronic application or for more information on the electronic submission process, visit <a href="https://grants.nih.gov/grants/guide/url_redirect.php?id=82400">How to Apply &ndash; Application Guide</a>. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the <a href="https://grants.nih.gov/grants/how-to-apply-application-guide/due-dates-and-submission-policies/dealing-with-system-issues.htm">Dealing with System Issues</a> guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.</p>
<p class="Normal"><strong>Important reminders:</strong></p>
<p class="Normal">All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form<b>. </b>Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this NOFO for information on registration requirements.</p>
<p class="Normal">The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization&#146;s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the <a href="https://grants.nih.gov/grants/guide/url_redirect.php?id=82400">How to Apply - Application Guide</a>.</p>
<p class="Normal">See <a href="//grants.nih.gov/grants/guide/url_redirect.php?id=11146">more tips</a> for avoiding common errors.</p>
</div>
<div data-element-id="191638" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT">
<p>Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by NIMHD, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.</p>
</div>
<div data-element-id="191639" data-element-has-label="false" data-element-required="false" data-element-has-value="false" data-section-code="ASI" data-element-type="TEXT">
</div>
<div data-element-id="191640" data-element-has-label="false" data-element-required="false" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT">
<h4>&nbsp;</p>
</div>
<div data-element-id="191641" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT">
<p class="heading4">Post Submission Materials</p>
<p class="Normal">Applicants are required to follow the instructions for post-submission materials, as described in <a href="//grants.nih.gov/grants/guide/url_redirect.php?id=82299">the policy</a></p>
</div>
<div data-element-id="191642" data-element-has-label="false" data-element-required="false" data-element-has-value="false" data-section-code="ASI" data-element-type="TEXT">
</div>
<div data-element-id="191643" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ARI" data-element-type="TEXT">
<a name="_Section V. Application Review Information"></a><h2 class="heading2">Section V. Application Review Information</h2>
</div>
<div data-element-id="191644" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ARI" data-element-type="TEXT">
<p class="heading4">1. Criteria</p>
<p class="Normal">Only the review criteria described below will be considered in the review process. &nbsp;Applications submitted to the NIH in support of the <a href="//grants.nih.gov/grants/guide/url_redirect.php?id=11149">NIH mission</a> are evaluated for scientific and technical merit through the NIH peer review system.</p>
</div>
<div data-element-id="191646" data-element-has-label="false" data-element-required="false" data-element-has-value="false" data-section-code="ARI" data-element-type="TEXT">
</div>
<div data-element-id="191647" data-element-has-label="false" data-element-required="false" data-element-has-value="true" data-section-code="ARI" data-element-type="TEXT">
<p class="Normal">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>
<div class="heading4" tabindex="0" data-element-id="191648" data-element-required="true" data-element-has-value="true" data-section-code="ARI" data-element-type="TEXT">
Overall Impact
</div>
<div data-element-id="191648" data-element-has-label="true" data-element-required="true" data-element-has-value="true" data-section-code="ARI" data-element-type="TEXT">
<p class="Normal">Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).</p>
</div>
<div class="heading4" tabindex="0" data-element-id="191649" data-element-required="true" data-element-has-value="true" data-section-code="ARI" data-element-type="TEXT">
Scored Review Criteria
</div>
<div data-element-id="191649" data-element-has-label="true" data-element-required="true" data-element-has-value="true" data-section-code="ARI" data-element-type="TEXT">
<p class="Normal">Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.</p>
</div>
<div data-element-id="191650" data-element-has-label="false" data-element-required="false" data-element-has-value="true" data-section-code="ARI" data-element-type="LINKED_ELEMENT">
<div class="P_SingleIndent criteria-div"> <div>
<label class="heading4">Significance</label>&nbsp;<br/>
<span><p>Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?</p><p><strong>In addition, for applications involving clinical trials</strong></p><p>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></span>
<span><p><strong>Specific to this NOFO</strong>: Are the communities of focus clearly defined and justified, including the populations experiencing health disparities to be included? Is a clear and compelling conceptual model provided that describes hypothesized causal pathways between the community-level intervention, community-level determinants, and health outcomes? Does the intervention have the potential to be sustainable in the community after the project is over and scalable to other communities?</p></span>
</div>
<div>
<label class="heading4">Investigator(s)</label>&nbsp;<br/>
<span><p>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><strong>In addition, for applications involving clinical trials</strong></p><p>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></span>
<span><p><strong>Specific to this NOFO:&nbsp;</strong>Are the roles of community partners specified and justified?</p></span>
</div>
<div>
<label class="heading4">Innovation</label>&nbsp;<br/>
<span><p class="Normal">Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?</p>
<p class="Normal"><strong>In addition, for applications involving clinical trials</strong></p>
<p class="Normal">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>
</span>
<span></span>
</div>
<div>
<label class="heading4">Approach</label>&nbsp;<br/>
<span><p class="Normal">Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?&#160;</p>
<p class="Normal">If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?</p>
<p class="Normal"><strong>In addition, for applications involving clinical trials</strong></p>
<p class="Normal">Does the application adequately address the following, if applicable</p>
<p class="Normal"><em>Study Design </em></p>
<p class="Normal">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="Normal">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="Normal">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="Normal"><em>Data Management and Statistical Analysis </em></p>
<p class="Normal">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>
</span>
<span><p><strong>Specific to this NOFO:&nbsp;</strong>Are data sources that will be used to assess changes in community-level determinants clearly specified and appropriate? Is an appropriate data analytic plan provided that specifies how community-level and/or multi-level intervention effects and interactions or outcomes will be handled?</p></span>
</div>
<div>
<label class="heading4">Environment</label>&nbsp;<br/>
<span><p class="Normal">Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?</p>
<p class="Normal"><strong>In addition, for applications involving clinical trials</strong></p>
<p class="Normal">If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?</p>
<p class="Normal">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="Normal">If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?</p>
<p class="Normal">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>
</span>
<span><p><strong>Specific to this NOFO:</strong> Do letters of support indicate involvement and endorsement of the community-level intervention(s) by collaborators and/or leaders from within the community?</p></span>
</div>
</div>
</div>
<div class="heading4" tabindex="0" data-element-id="191651" data-element-required="true" data-element-has-value="true" data-section-code="ARI" data-element-type="TEXT">
Additional Review Criteria
</div>
<div data-element-id="191651" data-element-has-label="true" data-element-required="true" data-element-has-value="true" data-section-code="ARI" data-element-type="TEXT">
<p>As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.</p>
</div>
<div data-element-id="191652" data-element-has-label="false" data-element-required="false" data-element-has-value="true" data-section-code="ARI" data-element-type="LINKED_ELEMENT">
<div class="P_SingleIndent criteria-div"> <div>
<label class="heading4">Study Timeline</label>&nbsp;<br/>
<span><p><strong>Specific to applications involving clinical trials</strong></p><p>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>Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?</p></span>
<span></span>
</div>
<div>
<label class="heading4">Protections for Human Subjects</label>&nbsp;<br/>
<span><p class="Normal">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="Normal">For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the <a href="//grants.nih.gov/grants/guide/url_redirect.php?id=11175">Guidelines for the Review of Human Subjects</a>.</p>
</span>
<span></span>
</div>
<div>
<label class="heading4">Inclusion of Women, Minorities, and Individuals Across the Lifespan</label>&nbsp;<br/>
<span><p class="Normal">When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the <a href="//grants.nih.gov/grants/guide/url_redirect.php?id=11174">Guidelines for the Review of Inclusion in Clinical Research</a>.</p>
</span>
<span></span>
</div>
<div>
<label class="heading4">Vertebrate Animals</label>&nbsp;<br/>
<span><p class="Normal">The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the <a href="//grants.nih.gov/grants/guide/url_redirect.php?id=11150">Worksheet for Review of the Vertebrate Animals Section.</a></p>
</span>
<span></span>
</div>
<div>
<label class="heading4">Biohazards</label>&nbsp;<br/>
<span><p class="Normal">Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.</p>
</span>
<span></span>
</div>
<div>
<label class="heading4">Resubmissions</label>&nbsp;<br/>
<span></span>
<span><p>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></span>
</div>
<div>
<label class="heading4">Renewals</label>&nbsp;<br/>
<span></span>
<span><p>Not Applicable. &nbsp;</p></span>
</div>
<div>
<label class="heading4">Revisions</label>&nbsp;<br/>
<span></span>
<span><p>Not Applicable. &nbsp;</p></span>
</div>
</div>
</div>
<div class="heading4" tabindex="0" data-element-id="191653" data-element-required="true" data-element-has-value="true" data-section-code="ARI" data-element-type="TEXT">
Additional Review Considerations
</div>
<div data-element-id="191653" data-element-has-label="true" data-element-required="true" data-element-has-value="true" data-section-code="ARI" data-element-type="TEXT">
<p class="Normal">As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.</p>
</div>
<div data-element-id="191654" data-element-has-label="false" data-element-required="false" data-element-has-value="true" data-section-code="ARI" data-element-type="LINKED_ELEMENT">
<div class="P_SingleIndent criteria-div"> <div>
<label class="heading4">Applications from Foreign Organizations</label>&nbsp;<br/>
<span></span>
<span><p>Not Applicable.&nbsp;</p></span>
</div>
<div>
<label class="heading4">Select Agent Research</label>&nbsp;<br/>
<span><p>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></span>
<span></span>
</div>
<div>
<label class="heading4">Resource Sharing Plans</label>&nbsp;<br/>
<span><p>Reviewers will comment on whether the Resource Sharing Plan(s) (e.g., <a href="https://sharing.nih.gov/other-sharing-policies/model-organism-sharing-policy#policy-overview">Sharing Model Organisms</a>) or the rationale for not sharing the resources, is reasonable.</p></span>
<span></span>
</div>
<div>
<label class="heading4">Authentication of Key Biological and/or Chemical Resources</label>&nbsp;<br/>
<span><p>For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.</p></span>
<span></span>
</div>
<div>
<label class="heading4">Budget and Period of Support</label>&nbsp;<br/>
<span><p>Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.</p></span>
<span></span>
</div>
</div>
</div>
<div data-element-id="191655" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ARI" data-element-type="TEXT">
<p class="heading4">2. Review and Selection Process</p>
</div>
<div data-element-id="191656" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ARI" data-element-type="TEXT">
<p>Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review&nbsp;, in accordance with <a href="//grants.nih.gov/grants/guide/url_redirect.php?id=11154">NIH peer review policies and practices</a>, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.</p>
</div>
<div data-element-id="191657" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ARI" data-element-type="TEXT">
<p class="Normal">As part of the scientific peer review, all applications will receive a written critique.</p>
</div>
<div data-element-id="191658" data-element-has-label="false" data-element-required="false" data-element-has-value="true" data-section-code="ARI" data-element-type="TEXT">
<p class="Normal">Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.</p>
</div>
<div data-element-id="191659" data-element-has-label="false" data-element-required="false" data-element-has-value="false" data-section-code="ARI" data-element-type="CHECKBOX">
</div>
<div data-element-id="191660" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ARI" data-element-type="TEXT">
<p>Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the 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><li>Representation of populations that experience health disparities, geographic regions, and health conditions addressed.</li></ul>
</div>
<div data-element-id="191661" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ARI" data-element-type="TEXT">
<p class="heading4">3. Anticipated Announcement and Award Dates</p>
<p class="Normal">After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the&nbsp;<a href="//grants.nih.gov/grants/guide/url_redirect.php?id=11123">eRA Commons</a>.&nbsp;Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.</p>
<p class="Normal">Information regarding the disposition of applications is available in the&nbsp;<a href="//grants.nih.gov/grants/guide/url_redirect.php?id=82416">NIH Grants Policy Statement Section 2.4.4 Disposition of Applications</a>.</p>
</div>
<div data-element-id="191662" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="AAI" data-element-type="TEXT">
<a name="_Section VI. Award Administration Information"></a><h2 class="heading2">Section VI. Award Administration Information</h2>
</div>
<div data-element-id="191663" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="AAI" data-element-type="TEXT">
<p class="heading4">1. Award Notices</p>
<p class="Normal">If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the&nbsp;<a href="//grants.nih.gov/grants/guide/url_redirect.php?id=82418">NIH Grants Policy Statement</a>. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.&nbsp;</p>
<p class="Normal">A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.</p>
<p class="Normal">Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.</p>
<p class="Normal">Any application awarded in response to this NOFO will be subject to terms and conditions found on the <a href="https://grants.nih.gov/grants/policy/nihgps/HTML5/part_ii_subpart_b.htm">Award Conditions and Information for NIH Grants</a> website.&nbsp; This includes any recent legislation and policy applicable to awards that is highlighted on this website.</p>
</div>
<div data-element-id="191664" data-element-has-label="false" data-element-required="false" data-element-has-value="true" data-section-code="AAI" data-element-type="TEXT">
<p class="Normal">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 class="Normal">ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain &#147;applicable clinical trials&#148; 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 class="Normal">Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.</p>
<p class="Normal">Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at <a href="//grants.nih.gov/grants/policy/hs/data_safety.htm">http://grants.nih.gov/grants/policy/hs/data_safety.htm</a> and in the application instructions (SF424 (R&amp;R) and PHS 398).</p>
<p class="Normal">Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).</p>
</div>
<div data-element-id="191665" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="AAI" data-element-type="TEXT">
<h4>2. Administrative and National Policy Requirements</h4><p>All NIH grant and cooperative agreement awards include the <a href="//grants.nih.gov/grants/guide/url_redirect.php?id=11120">NIH Grants Policy Statement</a> as part of the NoA. For these terms of award, see the <a href="//grants.nih.gov/grants/guide/url_redirect.php?id=11157">NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General</a> and <a href="//grants.nih.gov/grants/guide/url_redirect.php?id=11159">Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities</a>, including of note, but not limited to:</p><ul><li><a href="https://grants.nih.gov/grants/policy/nihgps/HTML5/section_3/3.1_federalwide_standard_terms_and_conditions_for_research_grants.htm">Federalwide Standard Terms and Conditions for Research Grants</a></li><li><a href="//grants.nih.gov/grants/guide/url_redirect.php?id=82417">Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment</a></li><li><a href="https://grants.nih.gov/grants/policy/nihgps/HTML5/section_4/4.2.1_acknowledgement_of_federal_funding.htm">Acknowledgment of Federal Funding</a></li></ul><p>If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.</p><p>If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (<a href="https://www.hhs.gov/sites/default/files/form-hhs690.pdf">HHS-690</a>). To learn more, see the <a href="https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/laws/index.html">Laws and Regulations Enforced by the HHS Office for Civil Rights website</a>.</p><p>HHS recognizes that NIH research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator&#146;s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.</p><p>In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to System for Award Management (SAM.gov) requirements. SAM.gov requires Federal agencies to review and consider information about an applicant in the designated integrity and performance system (currently SAM.gov) prior to making an award. An applicant can review and comment on any information in the responsibility/qualification records available in SAM.gov. NIH will consider any comments by the applicant, in addition to the information available in the responsibility/qualification records in SAM.gov, in making a judgement about the applicant&#146;s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 2 CFR Part 200.206 &#147;Federal awarding agency review of risk posed by applicants.&#148; This provision will apply to all NIH grants and cooperative agreements except fellowships.</p>
</div>
<div class="heading4" tabindex="0" data-element-id="191666" data-element-required="true" data-element-has-value="true" data-section-code="AAI" data-element-type="TEXT">
Cooperative Agreement Terms and Conditions of Award
</div>
<div data-element-id="191666" data-element-has-label="true" data-element-required="true" data-element-has-value="true" data-section-code="AAI" data-element-type="TEXT">
<p class="Normal">Not Applicable</p>
</div>
<div data-element-id="191667" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="AAI" data-element-type="TEXT">
<p class="heading4">3. Data Management and Sharing</p>
<p class="Normal">Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the <a href="https://grants.nih.gov/grants/policy/nihgps/HTML5/section_8/8.2.3_sharing_research_resources.htm#Data">NIH Grants Policy Statement</a>. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.</p>
</div>
<div data-element-id="191668" data-element-has-label="false" data-element-required="false" data-element-has-value="false" data-section-code="AAI" data-element-type="TEXT">
</div>
<div data-element-id="191669" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="AAI" data-element-type="TEXT">
<p class="heading4">4. Reporting</p>
<p class="Normal">When multiple years are involved, recipients will be required to submit the&nbsp;<a href="//grants.nih.gov/grants/rppr/index.htm">Research Performance Progress Report (RPPR)</a>&nbsp;annually and financial statements as required in the <a href="//grants.nih.gov/grants/guide/url_redirect.php?id=82419">NIH Grants Policy Statement</a>.</p>
</div>
<div data-element-id="191670" data-element-has-label="false" data-element-required="false" data-element-has-value="false" data-section-code="AAI" data-element-type="TEXT">
</div>
<div data-element-id="191671" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="AAI" data-element-type="TEXT">
<p>A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the <a href="//grants.nih.gov/grants/guide/url_redirect.php?id=82420">NIH Grants Policy Statement</a>. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.</p><p>The Federal Funding Accountability and Transparency Act of 2006 as amended (FFATA), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.&nbsp; All recipients of applicable NIH grants and cooperative agreements&nbsp;are required to report to the Federal Subaward Reporting System (FSRS) available at <a href="//grants.nih.gov/grants/guide/url_redirect.php?id=11170">www.fsrs.gov</a> on all subawards over the threshold.&nbsp;&nbsp;See the <a href="//grants.nih.gov/grants/guide/url_redirect.php?id=82420">NIH Grants Policy Statement</a> for additional information on this reporting requirement.</p><p>In accordance with the regulatory requirements provided at 2 CFR Part 200.113 and Appendix XII to 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM)&nbsp;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.&nbsp; The recipient must also make semiannual disclosures regarding such proceedings.&nbsp;Proceedings information will be made publicly available in the designated integrity and performance system (Responsibility/Qualification in SAM.gov, formerly FAPIIS).&nbsp;&nbsp;This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).&nbsp; 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.&nbsp;&nbsp;Full reporting requirements and procedures are found in Appendix XII to 2 CFR Part 200 &ndash; Award Term and Condition&nbsp;for Recipient Integrity and Performance Matters.</p>
</div>
<div class="heading4" tabindex="0" data-element-id="191672" data-element-required="false" data-element-has-value="true" data-section-code="AAI" data-element-type="TEXT">
5. Evaluation
</div>
<div data-element-id="191672" data-element-has-label="true" data-element-required="false" data-element-has-value="true" data-section-code="AAI" data-element-type="TEXT">
<p class="Normal">Enter text here.</p>
</div>
<div data-element-id="191673" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="AC" data-element-type="TEXT">
<a name="_Section VII. Agency Contacts"></a><h2 class="heading2">Section VII. Agency Contacts</h2>
</div>
<div data-element-id="191674" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="AC" data-element-type="TEXT">
<p>We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.</p>
</div>
<div class="heading4" tabindex="0" data-element-id="191675" data-element-required="true" data-element-has-value="true" data-section-code="AC" data-element-type="TEXT">
Application Submission Contacts
</div>
<div data-element-id="191675" data-element-has-label="true" data-element-required="true" data-element-has-value="true" data-section-code="AC" data-element-type="TEXT">
<p class="Normal">eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten&nbsp;submission by the due date, and post-submission issues)</p>
<p class="Normal">Finding Help Online:&nbsp;<a href="https://www.era.nih.gov/need-help" target="_blank" title="https://www.era.nih.gov/need-help">https://www.era.nih.gov/need-help</a>&nbsp;(preferred method of contact)<br>
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)</p>
<p class="Normal">General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)<br>
Email:&nbsp;<a href="/cdn-cgi/l/email-protection#2e695c4f405a5d674048416e40474600494158"><span class="__cf_email__" data-cfemail="723500131c06013b1c141d321c1b1a5c151d04">[email&#160;protected]</span></a>&nbsp;(preferred method of contact)<br>
Telephone: 301-637-3015</p>
<p class="Normal">Grants.gov Customer Support&nbsp;(Questions regarding Grants.gov registration and Workspace)<br>
Contact Center Telephone: 800-518-4726<br>
Email:&nbsp;<a href="/cdn-cgi/l/email-protection#2a595f5a5a45585e6a4d584b445e59044d455c"><span class="__cf_email__" data-cfemail="53202623233c2127133421323d27207d343c25">[email&#160;protected]</span></a></p>
</div>
<div class="heading4" tabindex="0" data-element-id="191676" data-element-required="true" data-element-has-value="true" data-section-code="AC" data-element-type="TEXT">
Scientific/Research Contact(s)
</div>
<div data-element-id="191676" data-element-has-label="true" data-element-required="true" data-element-has-value="true" data-section-code="AC" data-element-type="TEXT">
<p>Crystal L. Barksdale, PhD, MPH<br>National Institute on Minority Health and Health Disparities (NIMHD)<br>Telephone: 301-827-4288<br>Email:&nbsp;<a href="/cdn-cgi/l/email-protection#2241505b5156434e0c404350495146434e47624c4b4a0c454d54"><span class="__cf_email__" data-cfemail="86e5f4fff5f2e7eaa8e4e7f4edf5e2e7eae3c6e8efeea8e1e9f0">[email&#160;protected]</span></a>&nbsp;</p>
</div>
<div class="heading4" tabindex="0" data-element-id="191678" data-element-required="true" data-element-has-value="true" data-section-code="AC" data-element-type="TEXT">
Peer Review Contact(s)
</div>
<div data-element-id="191678" data-element-has-label="true" data-element-required="true" data-element-has-value="true" data-section-code="AC" data-element-type="TEXT">
<p>Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).</p>
</div>
<div class="heading4" tabindex="0" data-element-id="191680" data-element-required="true" data-element-has-value="true" data-section-code="AC" data-element-type="TEXT">
Financial/Grants Management Contact(s)
</div>
<div data-element-id="191680" data-element-has-label="true" data-element-required="true" data-element-has-value="true" data-section-code="AC" data-element-type="TEXT">
<p>Priscilla Grant, JD<br>National Institute on Minority Health and Health Disparities (NIMHD)</span><br>Telephone: 301-594-8412</span><br>Email: </span><a href="/cdn-cgi/l/email-protection#48382f7b702008262120662f273e"><span class="__cf_email__" data-cfemail="235344101b4b634d4a4b0d444c55">[email&#160;protected]</span></a>&nbsp;</p>
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<a name="_Section VIII. Other Information"></a><h2 class="heading2">Section VIII. Other Information</h2>
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<p class="Normal">Recently issued trans-NIH <a href="//grants.nih.gov/grants/guide/url_redirect.php?id=11163">policy notices</a> may affect your application submission. A full list of policy notices published by NIH is provided in the <a href="//grants.nih.gov/grants/guide/url_redirect.php?id=11164">NIH Guide for Grants and Contracts</a>. All awards are subject to the terms and conditions, cost principles, and other considerations described in the <a href="//grants.nih.gov/grants/guide/url_redirect.php?id=11120">NIH Grants Policy Statement</a>.</p>
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Authority and Regulations
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<p class="Normal">Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.</p>
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<A HREF="/grants/guide/WeeklyIndex.cfm?06-14-24">Weekly TOC for this Announcement</A><br>
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