Expired PAR-20-302: Tobacco Control Policies to Promote Health Equity (R01 Clinical Trial Optional)

<script>(function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start': new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0], j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src= 'https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f); })(window,document,'script','dataLayer','GTM-T2DH393N');</script>  <HTML lang="en-US"> <HEAD>  <TITLE>Expired PAR-20-302: Tobacco Control Policies to Promote Health Equity (R01 Clinical Trial Optional)</TITLE> <META NAME="description" CONTENT="NIH Funding Opportunities and Notices in the NIH Guide for Grants and Contracts: Tobacco Control Policies to Promote Health Equity (R01 Clinical Trial Optional) PAR-20-302. NCI"> <META NAME="Keywords" CONTENT="PAR-20-302: Tobacco Control Policies to Promote Health Equity (R01 Clinical Trial Optional)"> <meta name="viewport" content="width=device-width, initial-scale=1.0"> <link href="../guide_styles/css/bootstrap.min.css" rel="stylesheet"> <link href="../guide_styles/css/style.css" rel="stylesheet"> <link href="../guide_styles/css/FOAM_Style.css" rel="stylesheet"> </HEAD> <BODY> <link type="text/css" href="../guide_styles/css/expired.css" rel="stylesheet" media="all"> <div class="noticeBar">This notice has expired. Check the <a href="https://grants.nih.gov/funding/searchguide/">NIH Guide</a> for active opportunities and notices.</div> <div id="watermark_background"> <p id="watermark_text">EXPIRED</p> </div> <div class="container"> <div class="row"> <div class="col-xs-12"> <div class="container"> <div class="row"> <div id="page-title" class="heading1" tabindex="0">Department of Health and Human Services</div> <div>  </div> </div>  <div data-element-id="22446" data-element-has-label="false" data-element-required="false" data-element-has-value="true" data-section-code="OI" data-element-type="TEXT"> <a name="_Part_1._Overview"></a><h1 class="heading1">Part 1. Overview Information</h1> </div> <div class="row" data-index="2"> <div class="col-md-4 datalabel" tabindex="0" data-element-id="22447" data-element-required="true" data-element-has-value="true" data-section-code="OI" data-element-type="TEXT"> Participating Organization(s) </div> <div class="col-md-8 datacolumn"> <p>National Institutes of Health (<a href="http://www.nih.gov">NIH</a>)</p>  <p></p> </div> </div>  <div class="row" data-index="4"> <div class="col-md-4 datalabel" tabindex="0" data-element-id="22449" data-element-required="true" data-element-has-value="true" data-section-code="OI" data-element-type="LINKED_ELEMENT"> Components of Participating Organizations </div> <div class="col-md-8 datacolumn"> <p>National Cancer Institute (<a href="https://www.cancer.gov/" target="_blank">NCI</a>) <p>All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers. </p> <p>Division of Program Coordination, Planning and Strategic Initiatives, Office of Disease Prevention (<a href="https://prevention.nih.gov/" target="_blank">ODP</a>) </p> <p>National Institute on Minority Health and Health Disparities (<a href="https://nimhd.nih.gov/"> NIMHD </a>)</p>  <p></p> </div> </div>  <div class="row" data-index="6"> <div class="col-md-4 datalabel" tabindex="0" data-element-id="22451" data-element-required="true" data-element-has-value="true" data-section-code="OI" data-element-type="LINKED_ELEMENT"> Funding Opportunity Title </div> <div class="col-md-8 datacolumn"> <span class="title">Tobacco Control Policies to Promote Health Equity (R01 Clinical Trial Optional)</span> </div> </div>  <div class="row" data-index="7"> <div class="col-md-4 datalabel" tabindex="0" data-element-id="22452" 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&Search.x=0&Search.y=0&Search_Type=Activity">R01</a> Research Project Grant</p> </div> </div>  <div class="row" data-index="8"> <div class="col-md-4 datalabel" tabindex="0" data-element-id="22453" data-element-required="true" data-element-has-value="true" data-section-code="OI" data-element-type="TEXT"> Announcement Type </div> <div class="col-md-8 datacolumn"> <p class="Normal">Reissue of <a href="https://grants.nih.gov/grants/guide/pa-files/par-18-675.html">PAR-18-675</a> - U.S. Tobacco Control Policies to Reduce Health Disparities (R01 Clinical Trial Optional)</p> </div> </div>  <div class="row" data-index="9"> <div class="col-md-4 datalabel" tabindex="0" data-element-id="22454" 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"> <p><a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-23-012.html">NOT-OD-23-012</a> Reminder: FORMS-H Grant Application Forms and Instructions Must be Used for Due Dates On or After January 25, 2023 - New Grant Application Instructions Now Available</p> <p> <a href="/grants/guide/notice-files/NOT-OD-22-190.html">NOT-OD-22-190</a> - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, 2022</p> <p> <strong>October 28, 2021</strong> - Reminder: FORMS-G Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2022 - New Grant Application Instructions Now Available. See Notice <a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-22-018.html">NOT-OD-22-018</a>. </p> <p><strong>September 13, 2021</strong> - Updates to the Non-Discrimination Legal Requirements for NIH Recipients. See Notice <a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-181.html">NOT-OD-21-181</a>. </p> <p> <strong>August 5, 2021 </strong> - New NIH "FORMS-G" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2022. See Notice <a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-169.html">NOT-OD-21-169</a>. </p> <p><strong>August 5, 2021</strong> - Update: Notification of Upcoming Change in Federal-wide Unique Entity Identifier Requirements. See Notice <a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-170.html">NOT-OD-21-170</a> </p> <p><strong>April 20, 2021</strong> - Expanding Requirement for eRA Commons IDs to All Senior/Key Personnel. See Notice <a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-109.html">NOT-OD-21-109</a> </p> <p class="Normal"> <li><b>September 24, 2020 </b> - Notice of NIMHD Participation in PAR-20-302. See Notice <a href="/grants/guide/notice-files/NOT-MD-20-028.html">NOT-MD-20-028</a>.</li></p> </div> </div>  <div class="row" data-index="10"> <div class="col-md-4 datalabel" tabindex="0" data-element-id="22455" data-element-required="true" data-element-has-value="true" data-section-code="OI" data-element-type="LINKED_ELEMENT"> Funding Opportunity Announcement (FOA) Number </div> <div class="col-md-8 datacolumn"> <span class="noticenum">PAR-20-302</span> </div> </div>  <div class="row" data-index="11"> <div class="col-md-4 datalabel" tabindex="0" data-element-id="22456" data-element-required="true" data-element-has-value="true" data-section-code="OI" data-element-type="TEXT"> Companion Funding Opportunity </div> <div class="col-md-8 datacolumn"> <p class="Normal"> </span><a href="https://grants.nih.gov/grants/guide/pa-files/par-20-303.html">PAR-20-303</span></a></span>-Tobacco Control Policies to Promote Health Equity (R21 Clinical Trial Optional)</p> </div> </div>  <div class="row" data-index="12"> <div class="col-md-4 datalabel" tabindex="0" data-element-id="22457" 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>See <a href="#_3._Additional_Information">Section III. 3. Additional Information on Eligibility</a>.</p> </div> </div>  <div class="row" data-index="13"> <div class="col-md-4 datalabel" tabindex="0" data-element-id="22458" data-element-required="true" data-element-has-value="true" data-section-code="OI" data-element-type="TEXT"> Catalog of Federal Domestic Assistance (CFDA) Number(s) </div> <div class="col-md-8 datacolumn"> <p class="Normal">93.395, 93.307 </p> </div> </div>  <div class="row" data-index="14"> <div class="col-md-4 datalabel" tabindex="0" data-element-id="22459" data-element-required="true" data-element-has-value="true" data-section-code="OI" data-element-type="TEXT"> Funding Opportunity Purpose </div> <div class="col-md-8 datacolumn"> <p class="Normal">The purpose of this Funding Opportunity Announcement (FOA) is to support observational or intervention research focused on reducing disparities in tobacco use and secondhand smoke (SHS) exposure in the U.S. Specifically, this FOA aims to stimulate scientific inquiry focused on innovative state and local level tobacco prevention and control policies. The long-term goal of this FOA is to reduce disparities in tobacco-related cancers, and in doing so, to promote health equity among all populations. Applicants submitting applications related to health economics are encouraged to consult <a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-025.html">NOT-OD-16-025</a> to ensure that the research projects align with NIH mission priorities in health economics research.</p>  </div> </div>  <div data-element-id="22460" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="KD" data-element-type="TEXT"> <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="22461" 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"> September 04, 2020 </div> </div>  <div class="row" data-index="17"> <div class="col-md-4 datalabel" tabindex="0" data-element-id="22462" data-element-required="true" data-element-has-value="true" data-section-code="KD" data-element-type="DATE"> Open Date (Earliest Submission Date) </div> <div class="col-md-8 datacolumn"> October 12, 2020 </div> </div>  <div class="row" data-index="18"> <div class="col-md-4 datalabel" tabindex="0" data-element-id="22463" 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 class="Normal">30 days prior to the application due date</p> </div> </div>  <div class="row" data-index="19"> <div class="col-md-4 datalabel" tabindex="0" data-element-id="22464" data-element-required="true" data-element-has-value="true" data-section-code="KD" data-element-type="TEXT"> Application Due Date(s) </div> <div class="col-md-8 datacolumn"> <p class="Normal" style="margin:0in 0in 0.0001pt">November 12, 2020; thereafter, <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11111">Standard dates</a> apply.</p>  <p><p style="margin:0in 0in 0.0001pt">All applications are due by 5:00 PM local time of applicant organization. All <a href="#Application Types Allowed">types of non-AIDS applications</a> allowed for this funding opportunity announcement are due on the listed date(s).</p> <p style="margin:0in 0in 0.0001pt">Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.</p></p> </div> </div>  <div class="row" data-index="21"> <div class="col-md-4 datalabel" tabindex="0" data-element-id="22466" data-element-required="true" data-element-has-value="true" data-section-code="KD" data-element-type="TEXT"> AIDS Application Due Date(s) </div> <div class="col-md-8 datacolumn"> <p class="Normal">Not Applicable</p> </div> </div>  <div class="row" data-index="22"> <div class="col-md-4 datalabel" tabindex="0" data-element-id="22467" data-element-required="true" data-element-has-value="true" data-section-code="KD" data-element-type="TEXT"> Scientific Merit Review </div> <div class="col-md-8 datacolumn"> <p class="Normal"><a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11113">Standard dates</a> apply</p> </div> </div>  <div class="row" data-index="23"> <div class="col-md-4 datalabel" tabindex="0" data-element-id="22468" data-element-required="true" data-element-has-value="true" data-section-code="KD" data-element-type="TEXT"> Advisory Council Review </div> <div class="col-md-8 datacolumn"> <p class="Normal"><a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11113">Standard dates</a> apply</p> </div> </div>  <div class="row" data-index="24"> <div class="col-md-4 datalabel" tabindex="0" data-element-id="22469" data-element-required="true" data-element-has-value="true" data-section-code="KD" data-element-type="TEXT"> Earliest Start Date </div> <div class="col-md-8 datacolumn"> <p class="Normal"><a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11113">Standard dates</a> apply</p> </div> </div>  <div class="row" data-index="25"> <div class="col-md-4 datalabel" tabindex="0" data-element-id="22470" data-element-required="true" data-element-has-value="true" data-section-code="KD" data-element-type="DATE"> Expiration Date </div> <div class="col-md-8 datacolumn"> September 08, 2023 </div> </div>  <div class="row" data-index="26"> <div class="col-md-4 datalabel" tabindex="0" data-element-id="22471" data-element-required="true" data-element-has-value="true" data-section-code="KD" data-element-type="TEXT"> Due Dates for E.O. 12372 </div> <div class="col-md-8 datacolumn"> <p>Not Applicable</p>  </div> </div>  <div class="heading4" tabindex="0" data-element-id="22472" data-element-required="true" data-element-has-value="true" data-section-code="KD" data-element-type="TEXT"> Required Application Instructions </div> <div data-element-id="22472" data-element-has-label="true" data-element-required="true" data-element-has-value="true" data-section-code="KD" data-element-type="TEXT"> <p>It is critical that applicants follow the instructions in the Research (R) Instructions in the <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=12000">SF424 (R&R) Application Guide</a>,except where instructed to do otherwise (in this FOA or in a Notice from <a href="//grants.nih.gov/grants/guide/">NIH Guide for Grants and Contracts </a>).</p> <p>Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in <a href="#_Section_IV._Application_1">Section IV</a>. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.</p> <p><strong>Applications that do not comply with these instructions may be delayed or not accepted for review.</strong></p> </div> <div> <style> .assist_button { background-color: #4CAF50; /* Green */ border: none; color: white; padding: 8px 16px; text-align: center; text-decoration: none; display: inline-block; font-size: 14px; } .important { color: #F00; font-weight: bold; font-size 14px; } </style> <div class="heading1" tabindex="0">Table of Contents</div> <div class="toc-link"><a href="#_Part_1._Overview">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">Part 2. Full Text of Announcement </a></div><div class="toc-link P_SingleIndent"><a href="#_Section_I._Funding">Section I. Funding Opportunity Description </a></div><div class="toc-link P_SingleIndent"><a href="#_Section_II._Award_1">Section II. Award Information </a></div><div class="toc-link P_SingleIndent"><a href="#_Section_III._Eligibility">Section III. Eligibility Information </a></div><div class="toc-link P_SingleIndent"><a href="#_Section_IV._Application_1">Section IV. Application and Submission Information </a></div><div class="toc-link P_SingleIndent"><a href="#_Section_V._Application">Section V. Application Review Information </a></div><div class="toc-link P_SingleIndent"><a href="#_Section_VI._Award">Section VI. Award Administration Information </a></div><div class="toc-link P_SingleIndent"><a href="#_Section_VII._Agency">Section VII. Agency Contacts </a></div><div class="toc-link P_SingleIndent"><a href="#_Section_VIII._Other">Section VIII. Other Information </a></div> </div><br/>  <div data-element-id="22474" 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"></a><h1 class="heading1">Part 2. Full Text of Announcement</h1> </div>  <div data-element-id="22475" 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._Funding"></a><h2 class="heading2">Section I. Funding Opportunity Description</h2> </div>  <div data-element-id="22476" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="FOD" data-element-type="TEXT"> <p class="heading4">Purpose</p> <p class="Normal">This FOA seeks applications for research projects to help reduce disparities in tobacco use and secondhand smoke (SHS) exposure in the United States and promote health equity through scientific inquiry focused on innovative state and local tobacco prevention and control policies including, but not limited to:</p> <ul> <li class="Normal">protecting nonsmokers from secondhand smoke (SHS) exposure;</li> <li class="Normal">reducing appeal of tobacco products through state or local level restrictions on advertising and marketing;</li> <li class="Normal">reducing the demand for tobacco products through state or local level tax and pricing strategies;</li> <li class="Normal">providing insurance coverage for tobacco dependence treatment; and</li> <li class="Normal">other promising public and private tobacco control policy approaches.</li> </ul> <p class="Normal">The long-term goal of this FOA is to reduce tobacco-related cancer health disparities, and in doing so, to promote health equity among all populations. Applicants submitting applications related to health economics are encouraged to consult <a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-025.html">NOT-OD-16-025</a> to ensure that the research projects align with NIH mission priorities in health economics research.</p> <p class="Normal">Applicants may propose projects utilizing tobacco prevention and control strategies to promote health equity among all populations and reduce cancer health disparities in vulnerable populations. All applications must include an overall strategy that builds upon rigorous dissemination and implementation science. Investigators should include a well-designed plan for proactively disseminating research findings, including a specific plan for identifying and engaging critical community partners in the research, clearly described roles and responsibilities of key partners and plans regarding the nature and extent of future collaborations. Investigators should describe the communication plan and detailed list of responsible parties for decision-making and dissemination of research findings.</p> <p class="Normal">This FOA is proposed in response to the March 2016 Report to the NCI Board of Scientific Advisors, titled <a href="https://cancercontrol.cancer.gov/pdf/nci-tobacco-control-research-priorities-rpt-feb-2016.pdf">Tobacco Control Research Priorities for the Next Decade: Working Group Recommendations for 2016-2025</a>. This report concluded that research is needed to identify innovative local, state, federal and private sector policy approaches that will advance the goal of eliminating tobacco use and its resultant harms, as well as effective strategies to more completely disseminate these approaches and that research is needed to identify and implement tobacco control policies that reduce or eliminate tobacco-related inequalities. <a href="https://www.cdc.gov/tobacco/stateandcommunity/best-practices-health-equity/pdfs/bp-health-equity.pdf">Health Equity in Tobacco Prevention and Control</a> describes "health equity as the opportunity for everyone to reach their full potential, regardless of any socially determined circumstance. Health equity can be achieved in tobacco prevention and control by eliminating differences in tobacco use and exposure to secondhand smoke between certain groups."</p> <p class="Normal">This FOA will utilize the Research Project Grant (R01) mechanism and is suitable for projects where proof-of-principle of the proposed technology or methodology has already been established and supportive preliminary data are available.</p> <p class="Normal">This FOA runs in parallel with another FOA of identical scientific scope (<a href="https://grants.nih.gov/grants/guide/pa-files/par-20-303.html">PAR-20-303</a>)</span></span>, which utilizes the Exploratory/Developmental Grant (R21) mechanism.</p> <p class="heading4">Background and Rationale</p> <p class="Normal">The landmark <a href="https://profiles.nlm.nih.gov/NN/B/B/M/Q/">1964 Surgeon General’s report</a> on smoking and health began a process of public education, programmatic and policy intervention, and social norm change that has revolutionized how most Americans view commercial tobacco use, and in particular cigarette smoking. As a result, over the past five decades, the prevalence of cigarette smoking among U.S. adults has markedly declined from 42.4% in 1965 to 13.7% in 2018. Tobacco prevention and control efforts implemented since the 1964 Surgeon General’s report are estimated to have prevented 8 million premature smoking-attributable deaths in the United States and to have extended mean life span by 19-20 years, between the years 1964 and 2012.</p> <p class="Normal">Despite this progress, tobacco use remains the leading cause of preventable premature death in the U.S., as it does in most other high-income nations. The overall decline in prevalence masks substantial differences in adult cigarette smoking prevalence among different U.S. subpopulations, related to income, level of educational attainment, race or ethnicity, place of residence, health insurance coverage, the presence or absence of co-morbid mental health conditions and or substance abuse, and other factors. For example, in 2016, cigarette smoking prevalence was 14.3% among those living at or above the federal poverty level, compared with 25.3% among those living below the federal poverty level. In 2018, cigarette smoking prevalence was 29.2% among lesbian, gay, bisexual, and transgender (LGBT) adults compared with 19.5% among heterosexual adults. Similarly, exposure to SHS has dropped from about 50% of all nonsmokers in 1999-2000 to about 25% in 2013-2014. However, exposure remains especially high among some groups: approximately half of black nonsmokers are exposed to SHS, including seven in 10 black children; and SHS exposure is more than twice as high among nonsmokers living below the poverty level, compared with those living above the poverty level (48% vs. 21%, respectively).</p> <p class="Normal">Disparities in smoking prevalence are increasingly reflected in differences in lung cancer incidence and mortality. For example, in 2016, the age-adjusted incidence of lung and bronchus cancer per 100,000 persons ranged from 86.8 in Kentucky to 25.1 in Utah. A 2016 editorial in JAMA Oncology notes the close link between tobacco use rates and overall cancer mortality, stating, the variation [in overall cancer death rates] across states today is greater than the overall improvement in mortality over the past 40 years: cancer mortality varies as much as 30% across states, and is strongly associated with state-level tobacco use. Differences in tobacco use are also strongly linked to differences in overall mortality between population subgroups. For example, in the U.S., England, Wales, Canada, and Poland, more than half the difference in mortality between men of high vs. low social strata is due to differences in the risk of dying from smoking at ages 35-69. A continued focus on tobacco prevention and control efforts at the population level can help reduce tobacco use, as well as the incidence of lung and other cancers. For example, in California, both tobacco use and lung cancer mortality have declined faster than the national average, and this is expected to continue.</p> <p class="Normal">NCI Tobacco Control Monograph 22, <a href="https://cancercontrol.cancer.gov/brp/tcrb/monographs/22">A Socioecological Approach to Addressing Tobacco-Related Health Disparities</a>, concludes that knowledge of tobacco-related health disparities (TRHD) is "enhanced by considering the interaction of factors at the individual, interpersonal, community or neighborhood, and societal or policy levels, and by considering the impact of diverse factors across the tobacco use continuum over the life span. Additional research to understand and reduce TRHD and promote health equity is essential to reducing the burden of tobacco use and tobacco-related cancer in the United States."</p> <p class="Normal">Healthy People 2000 established the goal of reducing health disparities and expanded it to eliminating health disparities in Healthy People 2010. Healthy People 2020 (HP2020) includes addressing both health equity and health disparity and defines them as follows: Health equity: attainment of the highest level of health for all people. Achieving health equity requires valuing everyone equally with focused and ongoing societal efforts to address avoidable inequalities, historical and contemporary injustices, and the elimination of health and health care disparities. Health disparity is a particular type of health difference that is closely linked with social, economic, and or environmental disadvantage, and that adversely affects groups of people who have systematically experienced greater obstacles to health based on their racial or ethnic group; religion; SES; gender; age; mental health; disability; sexual orientation or gender identity; geographic location; or other characteristics historically linked to discrimination or exclusion. The HP 2020 goal combines both concepts to achieve health equity, eliminate disparities, and improve the health of all groups.</p> <p class="heading4">Key Challenges</p> <p class="Normal">Evidence-based policy approaches to tobacco prevention and control have the potential to further decrease the health and economic burdens of tobacco use and to reduce the wide disparities in tobacco use and tobacco-caused cancers across various subpopulations in the U.S. Policy interventions prioritize population-level outcomes by seeking to change the social-environmental context in which decisions about tobacco use are made. They may be especially valuable for reducing disparities in tobacco use and promoting health equity among all populations because of their broad reach, ability to change social norms, and because they can be implemented at much lower cost than interventions that target individuals. However, gaps in our understanding of tobacco control policies remain, especially as they relate to the ability of new and existing policies to reduce disparities in tobacco use and tobacco-related cancers and to promote health equity across all populations.</p> <p class="Normal">The nation’s tobacco prevention and control environment and policy landscape are increasingly complex and rapidly changing. <strong><em>Key challenges include the following:</em></strong></p> <ul> <li class="Normal">The significant advances in reducing tobacco use were achieved when cigarettes were the tobacco product used by the vast majority of Americans. Today, consumers are exposed to, and are increasingly using a wider variety of tobacco products, including cigars, little cigars and cigarillos, smokeless tobacco products, Electronic Nicotine Delivery Systems (ENDS), heated tobacco products, and waterpipes or hookah. Many of these tobacco products are relatively inexpensive, easy to obtain, and some are specifically marketed toward youth, young adults, certain racial or ethnic groups, or LGBT people. These products also pose new challenges to comprehensive smoke free policies, which may differ between population subgroups.</li> <li class="Normal">State and local marijuana laws are changing rapidly. As of October 2019, eleven states and Washington, DC, allow for personal possession and consumption of marijuana by adults. As of March 2020 33 states, and the District of Columbia, Guam, Puerto Rico, and the U.S. Virgin Islands have passed some type of medical marijuana measure. In addition, some tobacco products, especially cigars, cigarillos and ENDS, are now commonly used together with marijuana (cannabis) or cannabis oil. Less restrictive marijuana laws are widely expected to influence tobacco use patterns and may influence population subgroups differently.</li> <li class="Normal">The 2009 Family Smoking Prevention and Tobacco Control Act established the Food and Drug Administration (FDA) authority to regulate the manufacture, marketing, and distribution of tobacco products and expanded the ability of state and local governments to regulate tobacco product advertising. As a result, states and localities have now begun to implement innovative policies in this area, such as measures that restrict point-of-sale tobacco advertising or the sale of flavored tobacco products. These efforts hold promise to reduce tobacco use, including among populations with higher prevalence. State and local policy interventions may allow for more focused approaches to reducing disparities in tobacco use and promoting broader health equity.</li> <li class="Normal">The communication and media landscape is complex and rapidly changing, and online user-generated content and social networking sites (such as Facebook, Instagram, Twitter, and YouTube) have become an integral part of the communication landscape. Social media interactions may be used to promote tobacco prevention and control strategies, but may also have adverse effects on tobacco use, through the spread of inaccurate health information, the emergence of online communities with norms that support tobacco use, tobacco industry promotional efforts, and other means. Levels of computer ownership and high-speed internet access are lower among older Americans, Blacks, Hispanics, low-SES people, and people living outside metropolitan areas than among other groups; however, levels are substantial for all groups and are expected to continue to rise. Mobile technologies also offer the potential to reach rural populations, people with insufficient access to the health care system, and other high-risk groups.</li> </ul> <p class="Normal">We understand in this environment of the COVID-19 pandemic that the broader health, social, cultural and economic conditions may impact the adoption and implementation of tobacco prevention and control policies. Many of the same populations who are most at risk for tobacco use and tobacco-related cancers are the same people who are disproportionately bearing the health burden of the current COVID-19 pandemic. Applications should reflect current conditions and may consider interactions between tobacco prevention and control policies and factors related to the pandemic.</p> <p class="heading4">Research Objectives</p> <p class="Normal">The central charge of this FOA is to understand how to improve the effectiveness of existing tobacco prevention and control policy strategies as well as to study new policy approaches to reducing disparities in commercial tobacco use and SHS exposure. The knowledge generated will contribute to reducing disparities in tobacco-related cancers and promoting health equity for all populations.</p> <p class="Normal"><b><i>Primary research topics that fall within the scope of this FOA include, but are not limited to the following:</i></b></p> <p class="Normal" style="margin-left: 25px;">1. Comprehensive smoke free policies (e.g., how to increase adoption and implementation of comprehensive smoke free policies in workplaces, multi-unit housing, homes, vehicles, parks, etc.);</p> <p class="Normal" style="margin-left: 25px;">2. Policies to reduce the appeal of tobacco products through advertising and marketing restrictions at the state or local level, or reduce the demand for tobacco products with various pricing interventions;</p> <p class="Normal" style="margin-left: 25px;">3. Policies related to coverage for tobacco dependence treatment (e.g., state, local and or federal policies affect access to, affordability, and use of cessation services among high risk populations, and the impact of surcharges on tobacco users);</p> <p class="Normal" style="margin-left: 25px;">4. Overarching policy environment (e.g. studies that examine the dynamic interplay of different tobacco prevention and control policies on tobacco use, how tobacco control policies may work together to reduce tobacco use among both youth and adults, focusing on how to accelerate progress in communities that have experienced slower declines in tobacco use, etc.); and</p> <p class="Normal" style="margin-left: 25px;">5. Innovative dissemination and implementation of research findings.</p> <p class="Normal"><em><strong>Office of Disease Prevention- Shared Interest</strong></em></p> <p class="Normal">Data Harmonization for Substance Abuse and Addiction via the PhenX Toolkit: In order to encourage data integration and replication, the participating Institutes and Centers encourage investigators involved in human-subjects studies to employ a common set of tools and resources that will promote the collection of comparable data across studies. One way to do so is to incorporate the measures from the Core and Specialty collections, which are available in the Substance Abuse and Addiction Collection and the Tobacco Regulatory Research Collection of the PhenX Toolkit (<a href="http://www.phenxtoolkit.org" Title="Link to Non-U.S. Government Site">www.phenxtoolkit.org</a>). Please see NOT-DA-12-008 (<a href="https://grants.nih.gov/grants/guide/notice-files/NOT-DA-12-008.html">https://grants.nih.gov/grants/guide/notice-files/NOT-DA-12-008.html</a>) and NOT-OD-17-034 (<a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-034.html" title="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-034.html">https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-034.html</a>) for further details.</p> <p class="Normal">Data Harmonization for Social Determinants of Health (SDOH) via the PhenX Toolkit: Investigators involved in human-subject studies are encouraged to employ a common set of tools and resources that will promote the collection of comparable data on SDOH across studies. In particular, human-subject studies 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" Title="Link to Non-U.S. Government Site">www.phenxtoolkit.org</a>).</p> <p class="Normal"><b>Design, Analysis, and Sample Size Considerations for Studies to Evaluate Policies</b></p> <p class="Normal">Investigators who wish to evaluate the effect of a policy on a health-related biomedical or behavioral outcome may propose a study design in which groups that are subject to the policy are compared to groups that are not subject to the policy. Designs that might be proposed include a parallel group- or cluster-randomized trial, a stepped-wedge group- or cluster randomized trial, a multiple baseline design, or another quasi-experimental design. Whenever participants are assigned in groups or clusters (e.g., families, clinics, schools, worksites, communities, counties, states), or participants receive some part of their intervention in a group or cluster, and observations on individual participants are analyzed for between-group effects, special methods are required for analysis and sample size. Applicants will need to show that their methods are appropriate given their plans for assignment of participants and delivery of interventions. Additional information is available at<i> </i><a href="https://researchmethodsresources.nih.gov/"><i>https://researchmethodsresources.nih.gov/</i></a>.</p> <p class="heading4"><strong>Applications Not Responsive to this FOA</strong></p> <p class="Normal"><strong>Applications not responsive to this FOA will not be reviewed.</strong></p> <ul> <li class="Normal">Studies of biological mechanisms or disease processes.</li> </ul> </div>  <div data-element-id="22477" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="FOD" data-element-type="TEXT"> <p>See <a href="#_Section_VIII._Other">Section VIII. Other Information</a> for award authorities and regulations.</p> </div>  <div data-element-id="22478" 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_1"></a><h2 class="heading2">Section II. Award Information</h2> </div> <div class="row" data-index="34"> <div class="col-md-4 datalabel" tabindex="0" data-element-id="22479" 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 support 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="35"> <div class="col-md-4 datalabel" tabindex="0" data-element-id="22480" data-element-required="true" data-element-has-value="true" data-section-code="AI" data-element-type="MULTI_SELECT"> Application Types Allowed </div> <div class="col-md-8 datacolumn"> Resubmission<br/>New<br/>Renewal  <p>The <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11116"><font color="#0000ff">OER Glossary</font></a> and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.</p> </div> </div>  <div class="row" data-index="38"> <div class="col-md-4 datalabel" tabindex="0" data-element-id="22483" data-element-required="true" data-element-has-value="true" data-section-code="AI" data-element-type="SINGLE_SELECT"> Clinical Trial? </div> <div class="col-md-8 datacolumn"> Optional: Accepting applications that either propose or do not propose clinical trial(s)  <p><a href="https://grants.nih.gov/grants/guide/url_redirect.htm?id=82370">Need help determining whether you are doing a clinical trial?</a></p> </div> </div>  <div class="row" data-index="40"> <div class="col-md-4 datalabel" tabindex="0" data-element-id="22485" 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 class="Normal">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="41"> <div class="col-md-4 datalabel" tabindex="0" data-element-id="22486" 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"> Application budgets are not limited but need to reflect the actual needs of the proposed project. </div> </div>  <div class="row" data-index="42"> <div class="col-md-4 datalabel" tabindex="0" data-element-id="22487" 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 class="Normal">The scope of the proposed project should determine the project period. The maximum project period is 5 years.</p>  </div> </div>  <div data-element-id="22488" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="AI" data-element-type="TEXT"> <p>NIH grants policies as described in the <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11120">NIH Grants Policy Statement</a> will apply to the applications submitted and awards made from this FOA.</p> </div>  <div data-element-id="22489" 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"></a><h2 class="heading2">Section III. Eligibility Information</h2> </div>  <div data-element-id="22490" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="EI" data-element-type="TEXT"> <h4 class="heading4">1. Eligible Applicants</h4> </div>  <div class="heading4" tabindex="0" data-element-id="22491" data-element-required="true" data-element-has-value="true" data-section-code="EI" data-element-type="TEXT"> Eligible Organizations </div> <div data-element-id="22491" 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="22492" data-element-has-label="false" data-element-required="false" data-element-has-value="true" data-section-code="EI" data-element-type="RADIO_BUTTON"> <p class="Normal">Federal Governments</p><ul> <li class="Normal">Eligible Agencies of the Federal Government</li> <li class="Normal">U.S. Territory or Possession</li></ul> </div>  <div data-element-id="22493" 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="22495" 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="22496" data-element-required="true" data-element-has-value="false" data-section-code="EI" data-element-type="TEXT"> Foreign Institutions </div> <div data-element-id="22496" 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="22497" 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.) Entities (Foreign Institutions) <strong>are not</strong> eligible to apply.</p> </div>  <div data-element-id="22498" 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="22499" 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.htm?id=11118">defined in the <em>NIH Grants Policy Statement</em></a>, <strong>are not</strong> allowed. </p> </div>  <div class="heading4" tabindex="0" data-element-id="22500" data-element-required="true" data-element-has-value="true" data-section-code="EI" data-element-type="TEXT"> Required Registrations </div> <div data-element-id="22500" 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 SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The <a href="//grants.nih.gov/grants/guide/notice-files/NOT-OD-15-039.html">NIH Policy on Late Submission of Grant Applications</a> states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.</p> <ul> <li><a href="http://fedgov.dnb.com/webform" Title="Link to Non-U.S. Government Site">Dun and Bradstreet Universal Numbering System (DUNS)</a> - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.</li> <li><a href="https://www.sam.gov/portal/public/SAM/">System for Award Management (SAM)</a> Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code. <ul> <li><a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11176">NATO Commercial and Government Entity (NCAGE) Code</a> Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. </li> </ul> </li> <li><a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11123">eRA Commons</a> - Applicants must have an active DUNS number to register in eRA Commons. </span></span></span>Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. </span></span></span>eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.</li> <li>Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.</li> </ul> <p class="Normal"><strong>Program Directors/Principal Investigators (PD(s)/PI(s))</strong></p> <p class="Normal">All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.</p> </div>  <div class="heading4" tabindex="0" data-element-id="22501" 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="22501" data-element-has-label="true" data-element-required="true" data-element-has-value="true" data-section-code="EI" data-element-type="TEXT"> <p>Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.</p> <p>For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.</p> </div>  <div data-element-id="22502" 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="22503" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="EI" data-element-type="TEXT"> <h4 class="heading4">2. Cost Sharing</h4> <p>This FOA does not require cost sharing as defined in the <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11126">NIH Grants Policy Statement.</a></p> </div>  <div data-element-id="22504" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="EI" data-element-type="TEXT"> <h4 class="heading4"><a name="_3._Additional_Information"></a>3. Additional Information on Eligibility</h4> <h4 class="heading4">Number of Applications</h4> </div>  <div data-element-id="22505" 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. This means that the NIH will not accept:</p> <ul> <li class="Normal">A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.</li> <li class="Normal">A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.</li> <li class="Normal">An application that has substantial overlap with another application pending appeal of initial peer review (see <a href="//grants.nih.gov/grants/guide/notice-files/NOT-OD-11-101.html">NOT-OD-11-101</a>).</li> </ul> </div>  <div data-element-id="22506" 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="22507" 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_1"></a><h2 class="heading2">Section IV. Application and Submission Information</h2> </div>  <div data-element-id="22508" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT"> <h4 class="heading4">1. Requesting an Application Package</h4> <p>The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace </span></span></span>are available in <a href="#_Required_Application_Instructions">Part 1</a> of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.</p> </div>  <div data-element-id="22509" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT"> <h4 class="heading4">2. Content and Form of Application Submission</h4> It is critical that applicants follow the instructions in the Research (R) Instructions in the <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=12000">SF424 (R&R) Application Guide</a> except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review. </div>  <div data-element-id="22510" data-element-has-label="false" data-element-required="false" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT"> <p class="Normal"><normal class="Normal"><p class="heading4">Letter of Intent</p></normal></p> <p class="Normal">Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.</p> <p class="Normal">By the date listed in <a href="#_Part_1._Overview">Part 1. Overview Information</a>, prospective applicants are asked to submit a letter of intent that includes the following information:</p> <ul> <li class="Normal">Descriptive title of proposed activity</li> <li class="Normal">Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)</li> <li class="Normal">Names of other key personnel</li> <li class="Normal">Participating institution(s)</li> <li class="Normal">Number and title of this funding opportunity</li> </ul> <p class="Normal">The letter of intent should be sent to:</p> <p>Margaret Mayer, PhD, MPH</strong><br> National Cancer Institute (NCI)</strong><br> Telephone: 240-276-6433</strong><br> Email: <a href="/cdn-cgi/l/email-protection#2d404c5f4a4c5f485903404c54485f6d434445034a425b"><span class="__cf_email__" data-cfemail="412c203326203324356f2c20382433012f28296f262e37">[email protected]</span></a></strong></p> </div>  <div class="heading4" tabindex="0" data-element-id="22511" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT"> Page Limitations </div> <div data-element-id="22511" 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">All page limitations described in the SF424 Application Guide and the <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11133">Table of Page Limits</a> must be followed.</p> </div>  <div data-element-id="22512" 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="22513" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT"> Instructions for Application Submission </div> <p>Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing (DMS) Plan will be attached in the Other Plan(s) attachment in FORMS-H and subsequent application forms packages. For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages. </p> <div data-element-id="22513" 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 SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.</p> </div>  <div class="heading4" tabindex="0" data-element-id="22514" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT"> SF424(R&R) Cover </div> <div data-element-id="22514" 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">All instructions in the SF424 (R&R) Application Guide must be followed.</p> </div>  <div class="heading4" tabindex="0" data-element-id="22516" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT"> SF424(R&R) Project/Performance Site Locations </div> <div data-element-id="22516" 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">All instructions in the SF424 (R&R) Application Guide must be followed.</p> </div>  <div class="heading4" tabindex="0" data-element-id="22518" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT"> SF424(R&R) Other Project Information </div> <div data-element-id="22518" 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">All instructions in the SF424 (R&R) Application Guide must be followed.</p> </div>  <div data-element-id="22519" 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="22520" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT"> SF424(R&R) Senior/Key Person Profile </div> <div data-element-id="22520" 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">All instructions in the SF424 (R&R) Application Guide must be followed.</p> </div>  <div data-element-id="22522" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT"> <h4 class="heading4">R&R or Modular Budget</h4> <p class="Normal">All instructions in the SF424 (R&R) Application Guide must be followed.</p> </div>  <div class="heading4" tabindex="0" data-element-id="22524" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT"> R&R Subaward Budget </div> <div data-element-id="22524" 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">All instructions in the SF424 (R&R) Application Guide must be followed.</p> </div>  <div class="heading4" tabindex="0" data-element-id="22526" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT"> PHS 398 Cover Page Supplement </div> <div data-element-id="22526" 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">All instructions in the SF424 (R&R) Application Guide must be followed.</p> </div>  <div class="heading4" tabindex="0" data-element-id="22528" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT"> PHS 398 Research Plan </div> <p><b>Other Plan(s): </b></p> <p>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 and subsequent application forms packages. For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages. </p> <p>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.</p> <div data-element-id="22528" 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">All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:</p> </div>  <div data-element-id="22529" data-element-has-label="false" data-element-required="false" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT"> <p class="Normal"> </span>Dissemination and Implementation Science: All applications must include an overall strategy that builds upon rigorous dissemination and implementation science. Investigators should include a well-designed plan for proactively disseminating research findings, including a specific plan for identifying and engaging critical community partners in the research, clearly described roles and responsibilities of key partners and plans regarding the nature and extent of future collaborations. Investigators should describe the communication plan and detailed list of responsible parties for decision-making and dissemination of research findings.</p> <p class="Normal"><strong>Research Strategy:</strong> The sub-sections indicated below should address the following specific aspects.</p> <p class="Normal"><i>Innovation</i>:</p> <p class="Normal">Explain how the overall strategy employs innovative approaches that build upon rigorous dissemination and implementation science.</p> <p class="Normal"><i>Approach</i>:</p> <p class="Normal">The description in the sub-section must address and provide the necessary supporting details explaining how the proposed project will meet the following key dissemination and implementation science requirements:</p> <ul> <li class="Normal">All applications must include an overall strategy that builds upon rigorous dissemination and implementation science.</li> <li class="Normal">Investigators should include a well-designed plan for proactively disseminating research findings, including a specific plan for identifying and engaging critical community partners in the research, clearly described roles and responsibilities of key partners and plans regarding the nature and extent of future collaborations.</li> <li class="Normal">Investigators should describe the communication plan and detailed list of responsible parties for decision-making and dissemination of research findings.</li> </ul> </div>  <div data-element-id="22530" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT"> <p class="Normal"><strong>Resource Sharing Plan</strong>: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.</p> <p class="Normal">The following modifications also apply:</span></p> </div>  <div data-element-id="22531" data-element-has-label="false" data-element-required="false" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT"> <ul style="margin-left:25px;"> <li>All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.</li> </ul> </div>  <div class="heading4" tabindex="0" data-element-id="22532" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT"> Appendix: </div> <div data-element-id="22532" 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">Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.</p> <p class="Normal"></span></p> <p class="Normal"></span></p> </div>  <div data-element-id="22533" 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="22534" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT"> PHS Human Subjects and Clinical Trials Information </div> <div data-element-id="22534" 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">When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:</p> <p class="Normal">If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the <strong>Study Record: PHS Human Subjects and Clinical Trials Information </strong>form or <strong>Delayed Onset Study</strong> record.</p> <p class="Normal"><strong>Study Record: PHS Human Subjects and Clinical Trials Information</strong></p> <p class="Normal">All instructions in the SF424 (R&R) Application Guide must be followed.</p> </div>  <div data-element-id="22535" 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="22536" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT"> <strong>Delayed Onset Study</strong> <p>Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).</span></span></span>All instructions in the SF424 (R&R) Application Guide must be followed.</p> </div>  <div data-element-id="22537" 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="22538" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT"> PHS Assignment Request Form </div> <div data-element-id="22538" 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">All instructions in the SF424 (R&R) Application Guide must be followed.</p> </div>  <div data-element-id="22540" data-element-has-label="false" data-element-required="false" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT"> <h4 class="heading4"> </span></h4> </div>  <div data-element-id="22541" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT"> <h4 class="heading4">3. Unique Entity Identifier and System for Award Management (SAM)</h4> <p class="Normal">See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov</p> </div>  <div class="heading4" tabindex="0" data-element-id="22542" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT"> 4. Submission Dates and Times </div> <div data-element-id="22542" 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"><a href="#_Part_1._Overview">Part I. Overview Information</a> contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or <a href="https://grants.nih.gov/grants/guide/url_redirect.html?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.htm?id=11128" target="_blank">Grants.gov</a> (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11123" target="_blank">eRA Commons</a>, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.</p> <p class="Normal">Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.</p> <p class="Normal">Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.</p> </div>  <div data-element-id="22543" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT"> <h4 class="heading4">5. Intergovernmental Review (E.O. 12372)</h4> <p class="Normal">This initiative is not subject to <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11142">intergovernmental review.</a></p> </div>  <div class="heading4" tabindex="0" data-element-id="22544" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT"> 6. Funding Restrictions </div> <div data-element-id="22544" 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">All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11120">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.htm?id=11143">NIH Grants Policy Statement</a>.</p> </div>  <div data-element-id="22545" 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="22546" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT"> 7. Other Submission Requirements and Information </div> <div data-element-id="22546" 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">Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.</p> <p class="Normal">Applicants must complete all required registrations before the application due date. <a href="#_Section_III._Eligibility">Section III. Eligibility Information</a> contains information about registration.</p> <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/how-to-apply-application-guide.html" style="color:blue; text-decoration:underline">How to Apply Application Guide</a>. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the <a href="https://grants.nih.gov/grants/how-to-apply-application-guide/due-dates-and-submission-policies/dealing-with-system-issues.htm">Dealing with System Issues</a> guidance. For assistance with application submission, contact the Application Submission Contacts in <a href="#_Section_VII._Agency">Section VII</a>.</span></p> <p class="Normal" style="margin-left: 25px;"><strong>Important reminders:</strong></p> <p class="Normal" style="margin-left: 25px;">All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See <a href="#_Required_Registrations">Section III</a> of this FOA for information on registration requirements.</p> <p class="Normal" style="margin-left: 25px;">The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.</p> <p class="Normal" style="margin-left: 25px;">See <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11146">more tips</a> for avoiding common errors.</p> </div>  <div data-element-id="22547" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT"> <p class="Normal">Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.</p> </div>  <div data-element-id="22548" 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="22549" data-element-has-label="false" data-element-required="false" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT"> <p class="heading4">Requests of $500,000 or more for direct costs in any year</p> <p class="Normal">Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.</p> </div>  <div data-element-id="22550" 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="22551" data-element-required="true" data-element-has-value="true" data-section-code="ASI" data-element-type="TEXT"> Post Submission Materials </div> <div data-element-id="22551" 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">Applicants are required to follow the instructions for post-submission materials, as described in <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=82299">the policy</a>. Any instructions provided here are in addition to the instructions in the policy.</p> </div>  <div data-element-id="22552" 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="22553" 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"></a><h2 class="heading2">Section V. Application Review Information</h2> </div>  <div data-element-id="22554" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ARI" data-element-type="TEXT"> <h4 class="heading4">1. Criteria</h4> <p>Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) as part of the Resource Sharing Plan will not be evaluated at time of review.</p> <p class="Normal">Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11149">NIH mission</a> are evaluated for scientific and technical merit through the NIH peer review system.</p> </div>  <div data-element-id="22556" 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"><em>In addition, for applications involving clinical trials</em></p> <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="22557" data-element-required="true" data-element-has-value="true" data-section-code="ARI" data-element-type="TEXT"> Overall Impact </div> <div data-element-id="22557" 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="22558" 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="22558" 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="22559" 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" style="margin-left: 25px;">Significance</p> <p class="Normal" style="margin-left: 25px;">Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field</span></span></span>?</p> </div>  <div data-element-id="22560" 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"><strong>In addition, for applications involving clinical trials:</strong></p> <p class="Normal">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 the trial needed to advance scientific understanding?</p> </div>  <div data-element-id="22561" 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" style="margin-left: 25px;">Investigator(s)</p> <p class="Normal" style="margin-left: 25px;">Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?</p> </div>  <div data-element-id="22562" 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"><strong>In addition, for applications involving clinical trials:</strong>With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?</p> </div>  <div data-element-id="22563" 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" style="margin-left: 25px;">Innovation</p> <p class="Normal" style="margin-left: 25px;">Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?</p> </div>  <div data-element-id="22564" 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><b>Specific to this FOA</b>: Does the overall strategy employ innovative approaches that build upon rigorous dissemination and implementation science?</a></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> </div>  <div data-element-id="22565" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ARI" data-element-type="TEXT"> <h4 class="heading4" style="margin-left: 25px;">Approach</h4> <p class="Normal" style="margin-left: 25px;">Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?</p> </div>  <div data-element-id="22566" 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"><strong><a>Specific to this FOA: </a></strong><a>If the aims of the proposed project are achieved, how will the research findings be disseminated to relevant communities? How appropriate are the applicant’s plan for identifying and engaging critical community partners in research including clearly described roles and responsibilities of key partners; and plans regarding the nature and extent of future collaborations? </a>Does the application include a clearly articulated communication plan and detailed list of responsible parties for decision-making and dissemination of research findings, and how likely are these plans to ensure that they reach the intended audiences?</p> <p class="Normal"><strong>In addition, for applications involving clinical trials: </strong>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> </div>  <div data-element-id="22567" 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" style="margin-left: 25px;">If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults)</span></span></span>, justified in terms of the scientific goals and research strategy proposed?</p> </div>  <div data-element-id="22568" 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="22569" 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" style="margin-left: 25px;">Environment</p> <p class="Normal" style="margin-left: 25px;">Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?</p> </div>  <div data-element-id="22570" 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"><strong>In addition, for applications involving clinical trials: </strong>If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed? 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? If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial? If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?</p> </div>  <div data-element-id="22571" data-element-has-label="false" data-element-required="false" data-element-has-value="false" data-section-code="ARI" data-element-type="TEXT"> </div>  <div class="heading4" tabindex="0" data-element-id="22572" 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="22572" data-element-has-label="true" data-element-required="true" data-element-has-value="true" data-section-code="ARI" data-element-type="TEXT"> <p class="Normal">As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.</p> </div>  <div data-element-id="22573" data-element-has-label="false" data-element-required="false" data-element-has-value="true" data-section-code="ARI" data-element-type="TEXT"> <p class="heading4">Study Timeline</p> <p class="Normal"><em>Specific for applications involving clinical trials</em></p> <p class="Normal">Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?</p> <p class="Normal">Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?</p> </div>  <div data-element-id="22574" 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" style="margin-left: 25px;">Protections for Human Subjects</p> <p class="Normal" style="margin-left: 25px;">For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.</p> <p class="Normal" style="margin-left: 25px;">For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11175">Guidelines for the Review of Human Subjects</a>.</p> </div>  <div data-element-id="22575" 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" style="margin-left: 25px;">Inclusion of Women, Minorities, and Individuals Across the Lifespan</p> <p class="Normal" style="margin-left: 25px;">When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults)</span></span></span> to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11174">Guidelines for the Review of Inclusion in Clinical Research</a>.</p> </div>  <div data-element-id="22576" 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" style="margin-left: 25px;">Vertebrate Animals</p> <p class="Normal" style="margin-left: 25px;">The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11150">Worksheet for Review of the Vertebrate Animal Section</a>.</p> </div>  <div data-element-id="22577" 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" style="margin-left: 25px;">Biohazards</p> <p class="Normal" style="margin-left: 25px;">Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.</p> </div>  <div data-element-id="22578" 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" style="margin-left: 25px;">Resubmissions</p> </div>  <div data-element-id="22579" 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" style="margin-left: 25px;">For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.</p> </div>  <div data-element-id="22580" 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" style="margin-left: 25px;">Renewals</p> </div>  <div data-element-id="22581" 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" style="margin-left: 25px;">For Renewals, the committee will consider the progress made in the last funding period.</p> </div>  <div data-element-id="22582" 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" style="margin-left: 25px;">Revisions</p> </div>  <div data-element-id="22583" 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" style="margin-left: 25px;">Not Applicable</p> </div>  <div class="heading4" tabindex="0" data-element-id="22584" data-element-required="true" data-element-has-value="true" data-section-code="ARI" data-element-type="TEXT"> Additional Review Considerations </div> <p>Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) as part of the Resource Sharing Plan will not be evaluated at time of review.</p> <div data-element-id="22584" 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="22585" 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="22586" 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" style="margin-left: 25px;">Applications from Foreign Organizations</p> </div>  <div data-element-id="22587" 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" style="margin-left: 25px;">Not Applicable</p> </div>  <div data-element-id="22588" 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" style="margin-left: 25px;">Select Agent Research</p> <p class="Normal" style="margin-left: 25px;">Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).</p> </div>  <div data-element-id="22589" 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" style="margin-left: 25px;">Resource Sharing Plans</p> </div>  <div data-element-id="22590" 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" style="margin-left: 25px;">Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11151">Data Sharing Plan</a>; (2) <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11152">Sharing Model Organisms</a>; and (3) <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11153"> Genomic Data Sharing Plan (GDS)</a>.</p> </div>  <div data-element-id="22591" 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" style="margin-left: 25px;">Authentication of Key Biological and/or Chemical Resources:</p> <p class="Normal" style="margin-left: 25px;">For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.</p> </div>  <div data-element-id="22592" 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" style="margin-left: 25px;">Budget and Period of Support</p> <p class="Normal" style="margin-left: 25px;">Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.</p> </div>  <div data-element-id="22593" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ARI" data-element-type="TEXT"> <h4 class="heading4">2. Review and Selection Process</h4> </div>  <div data-element-id="22594" 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">Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific review (CSR), in accordance with <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11154"><font color="#0000ff">NIH peer review policy and procedures</font></a>, using the stated <a href="file:///C:/Users/mckenziene/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/13V4QPZR/Research%20Draft.doc#_1._Criteria"><font color="#0000ff">review criteria</font></a>. Assignment to a Scientific Review Group will be shown in the eRA Commons.</p> </div>  <div data-element-id="22595" 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="22596" 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="22599" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ARI" data-element-type="TEXT"> Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions: <ul style="margin-left:25px;"> <li>Scientific and technical merit of the proposed project as determined by scientific peer review.</li> <li>Availability of funds.</li> <li>Relevance of the proposed project to program priorities.</li> </ul> </div>  <div data-element-id="22600" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="ARI" data-element-type="TEXT"> <h4 class="heading4">3. Anticipated Announcement and Award Dates</h4> After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11123">eRA Commons</a>. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date. <p>Information regarding the disposition of applications is available in the <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11156">NIH Grants Policy Statement</a>.</p> </div>  <div data-element-id="22601" 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"></a><h2 class="heading2">Section VI. Award Administration Information</h2> </div>  <div data-element-id="22602" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="AAI" data-element-type="TEXT"> <h4 class="heading4">1. Award Notices</h4> If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11157">NIH Grants Policy Statement</a>. <p>A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.</p> <p>Awardees must comply with any funding restrictions described in <a href="#_5._Funding_Restrictions">Section IV.5. Funding Restrictions</a>. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.</p> <p>Any application awarded in response to this FOA will be subject to terms and conditions found on the <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11158">Award Conditions and Information for NIH Grants</a> website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.</p> </div>  <div data-element-id="22603" 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" style="margin:0in 0in 0.0001pt"> </span></p> </div>  <div data-element-id="22604" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="AAI" data-element-type="TEXT"> <h4 class="heading4">2. Administrative and National Policy Requirements</h4> <p class="Normal">All NIH grant and cooperative agreement awards include the <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11120"><i>NIH Grants Policy Statement</i></a> as part of the NoA. For these terms of award, see the <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11157"><i>NIH Grants Policy Statement</i> Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General</a> and <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11159">Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities</a>. More information is provided at <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11158">Award Conditions and Information for NIH Grants</a>.</p> <p class="Normal">Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see <a href="https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html">https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html</a> and <a href="http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html">http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html</a>.</p> <p class="Normal">HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.</p> <ul> <li class="Normal">Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. HHS provides guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see <a href="https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html">https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html</a> and <a href="https://www.lep.gov">https://www.lep.gov</a>. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at <a href="https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53">https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53</a>.</li> </ul> <ul> <li class="Normal">Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see <a href="http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html">http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html</a>.</li> </ul> <ul> <li class="Normal">HHS funded health and education programs must be administered in an environment free of sexual harassment. Please see <a href="https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html">https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html</a>; https://www2.ed.gov/about/offices/list/ocr/docs/shguide.html; and <a href="https://www.eeoc.gov/eeoc/publications/upload/fs-sex.pdf">https://www.eeoc.gov/eeoc/publications/upload/fs-sex.pdf</a>. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see <a href="https://grants.nih.gov/grants/policy/harassment.htm">https://grants.nih.gov/grants/policy/harassment.htm</a>.</li> </ul> <ul> <li class="Normal">Recipients of FFA must also administer their programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws. Collectively, these laws prohibit exclusion, adverse treatment, coercion, or other discrimination against persons or entities on the basis of their consciences, religious beliefs, or moral convictions. Please see <a href="https://www.hhs.gov/conscience/conscience-protections/index.html">https://www.hhs.gov/conscience/conscience-protections/index.html</a> and <a href="https://www.hhs.gov/conscience/religious-freedom/index.html">https://www.hhs.gov/conscience/religious-freedom/index.html</a>.</li> </ul> <p class="Normal">Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at <a href="https://www.hhs.gov/ocr/about-us/contact-us/index.html">https://www.hhs.gov/ocr/about-us/contact-us/index.html</a> or call 1-800-368-1019 or TDD 1-800-537-7697.</p> <p class="Normal">In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.</p> </div>  <div class="heading4" tabindex="0" data-element-id="22605" 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="22605" 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="22606" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="AAI" data-element-type="TEXT"> <p><strong>Data Management and Sharing</strong></p> <p>Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023. </p> <p>Consistent with the 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="/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> <h4 class="heading4">3. Reporting</h4> When multiple years are involved, awardees will be required to submit the <a href="//grants.nih.gov/grants/rppr/index.htm">Research Performance Progress Report (RPPR)</a> annually and financial statements as required in the <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11161">NIH Grants Policy Statement.</a> </div>  <div data-element-id="22607" 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="22608" 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.htm?id=11161">NIH Grants Policy Statement</a>.</p> <p>The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11170">www.fsrs.gov</a> on all subawards over $25,000. See the <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11171">NIH Grants Policy Statement</a> for additional information on this reporting requirement.</p> <p>In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.</p> </div>  <div data-element-id="22609" 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"></a><h2 class="heading2">Section VII. Agency Contacts</h2> </div>  <div data-element-id="22610" 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="22611" 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="22611" data-element-has-label="true" data-element-required="true" data-element-has-value="true" data-section-code="AC" data-element-type="TEXT"> <p>eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date</span></span></span>, and post-submission issues)</p> <p>Finding Help Online: <a href="//grants.nih.gov/support/">http://grants.nih.gov/support/</a> (preferred method of contact)<br /> Telephone: 301-402-7469 or 866-504-9552 (Toll Free)</p> <p>General Grants Information (Questions regarding application instructions, application </span></span></span>processes, and NIH grant resources)<br /> Email: <a href="/cdn-cgi/l/email-protection#bff8cdded1cbccf6d1d9d0ffd1d6d791d8d0c9"><span class="__cf_email__" data-cfemail="bcfbceddd2c8cff5d2dad3fcd2d5d492dbd3ca">[email protected]</span></a> (preferred method of contact)<br /> Telephone: 301-637-3015</p> <p>Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)<br /> Contact Center Telephone: 800-518-4726<br /> Email: <a href="/cdn-cgi/l/email-protection#c0b3b5b0b0afb2b480a7b2a1aeb4b3eea7afb6"><span class="__cf_email__" data-cfemail="285b5d5858475a5c684f5a49465c5b064f475e">[email protected]</span></a></p> </div>  <div class="heading4" tabindex="0" data-element-id="22612" 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="22612" data-element-has-label="true" data-element-required="true" data-element-has-value="true" data-section-code="AC" data-element-type="TEXT"> <p>Margaret Mayer, PhD, MPH</strong><br> National Cancer Institute (NCI)</strong><br> Telephone: 240-276-6433</strong><br> Email: <a href="/cdn-cgi/l/email-protection#fd909c8f9a9c8f9889d3909c84988fbd939495d39a928b"><span class="__cf_email__" data-cfemail="7b161a091c1a091e0f55161a021e093b151213551c140d">[email protected]</span></a></strong></p> <p>Annette Kaufman, PhD, MPH</strong><br> National Cancer Institute</strong><br> Telephone: 301-467-8521</strong><br> Email: <a href="/cdn-cgi/l/email-protection#2843495d4e45494649684549414406464140064f475e"><span class="__cf_email__" data-cfemail="62090317040f030c03220f030b0e4c0c0b0a4c050d14">[email protected]</span></a></strong></p> <p class="Normal">Mary L. Garcia-Cazarin, M.S., Ph.D.<br>Tobacco Regulatory Science Program<br>Office of Disease Prevention<br>Telephone: 301-451-2937<br><a href="/cdn-cgi/l/email-protection#a7cac6d5de89c0c6d5c4cec68ac4c6ddc6d5cec9e7c9cecf89c0c8d1">Email: <span class="__cf_email__" data-cfemail="620f03101b4c050310010b034f01031803100b0c220c0b0a4c050d14">[email protected]</span></a></p> <p class="Normal">Priscah Mujuru, Dr.PH, MPH, RN <br> National Institute on Minority Health and Health Disparities (NIMHD) <br> Telephone: 301-594-9765 <br> Email: <a href="/cdn-cgi/l/email-protection#49393b203a2a282167243c233c3b3c09272021672e263f"> <span class="__cf_email__" data-cfemail="f484869d8797959cda99819e818681b49a9d9cda939b82">[email protected]</span> </a> </p> </div>  <div class="heading4" tabindex="0" data-element-id="22613" 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="22613" data-element-has-label="true" data-element-required="true" data-element-has-value="true" data-section-code="AC" data-element-type="TEXT"> <p>Jacinta Bronte-Tinkew, PhD</strong><br> Center for Scientific Review (CSR)</strong><br> Telephone: 301-896-0009</strong><br> Email: <a href="/cdn-cgi/l/email-protection#6802090b01061c09460a1a07061c0d451c0106030d1f28060100460f071e"><span class="__cf_email__" data-cfemail="2c464d4f4542584d024e5e434258490158454247495b6c424544024b435a">[email protected]</span></a></strong></p> </div>  <div class="heading4" tabindex="0" data-element-id="22614" 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="22614" 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">Rebecca Brightful<br /> National Cancer Institute (NCI)<br /> Telephone: 301-631-3011<br /> Email:<a href="/cdn-cgi/l/email-protection#fa9888939d928e9c88ba979b9396d4949392d49d958c"><span class="__cf_email__" data-cfemail="2e4c5c4749465a485c6e434f47420040474600494158">[email protected]</span></a></p> <p class="Normal">Priscilla Grant, JD <br /> National Institute on Minority Health and Health Disparities (NIMHD) <br /> Telephone: 301-594-8412 <br /> Email: <a href="/cdn-cgi/l/email-protection#f08097c3c898b09e9998de979f86"><span class="__cf_email__" data-cfemail="e0829087d3d888a08e8988ce878f96">[email protected]</span></a></p> </div>  <div data-element-id="22615" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="OTI" data-element-type="TEXT"> <a name="_Section_VIII._Other"></a><h2 class="heading2">Section VIII. Other Information</h2> </div>  <div data-element-id="22616" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="OTI" data-element-type="TEXT"> <p class="Normal">Recently issued trans-NIH <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11163">policy notices</a> may affect your application submission. A full list of policy notices published by NIH is provided in the <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11164">NIH Guide for Grants and Contracts</a>. All awards are subject to the terms and conditions, cost principles, and other considerations described in the <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11120">NIH Grants Policy Statement</a>.</p> </div>  <div class="heading4" tabindex="0" data-element-id="22617" data-element-required="true" data-element-has-value="true" data-section-code="OTI" data-element-type="TEXT"> Authority and Regulations </div> <div data-element-id="22617" data-element-has-label="true" data-element-required="true" data-element-has-value="true" data-section-code="OTI" data-element-type="TEXT"> <p class="Normal">Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.</p> </div>  <div data-element-id="22618" data-element-has-label="false" data-element-required="false" data-element-has-value="true" data-section-code="OTI" data-element-type="TEXT"> <normal class="Normal"></normal> </div> </div> </div>  </div> </div> </div> <div class="row"> <div class="col-xs-12"> <P> <HR> <A HREF="/grants/guide/WeeklyIndex.cfm?09-04-20">Weekly TOC for this Announcement</A><br> <A HREF="/grants/guide/index.html">NIH Funding Opportunities and Notices</A> <hr> </div> </div> <div class="row"> <div class="col-md-4"> <a href="/grants/oer.htm"><img src="/images7/nih-oer-logo.jpg" alt="NIH Office of Extramural Research Logo" usemap="#Map2" border="0"></a> <map name="Map2" id="Map2"> <area shape="rect" coords="89,17,359,39" href="http://www.nih.gov" /> <area shape="rect" coords="91,39,286,58" href="http://grants.nih.gov/grants/oer.htm" /> <area shape="rect" coords="3,5,78,55" href="http://grants.nih.gov/grants/oer.htm" /> </map> </div> <div class="col-md-4"> <div style="float:left; padding: 5 5 5 70"> <a href="http://www.hhs.gov/"><img src="/images7/dhhs_sm.gif" width="36" height="37" border="0" alt="Department of Health and Human Services (HHS) - Home Page" long desc="Logo, circular in shape, depicting an American eagle in-flight with stylized profiles of human faces appearing on the trailing edge of the wings. The perimeter of the logo is encircled with the words 'Department of Health and Human Services U S A'"></a></div> <div style="padding: 5 5 5 5;">Department of Health<br> and Human Services (HHS)</div> </div> <div class="col-md-4"> <div style="padding: 5 5 5 0" align="center"> <a href="http://www.usa.gov/"><img src="/images7/USA_Gov_logo.gif" border="0" alt="USA.gov - Government Made Easy" long desc="Logo,- the words 'USA.gov - Government Made Easy' with single streaking star above the logo"></a> </div> </div> </div> <div class="row"> <div class="col-xs-12" align="center" style="padding: 20 5 5 5"> <span style="color:#6E6E6E; font-size:1.0em; font-family: 'Trebuchet MS', Arial, Helvetica, sans-serif">NIH... Turning Discovery Into Health<sup>®</sup></span> </div> </div> <div class="row"> <div class="col-xs-12" align="center"> </div> </div> </div> <script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></BODY> </HTML>

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