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<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-19-387: Perception and Cognition Research to Inform Cancer Image Interpretation (R01 Clinical Trial Optional)</TITLE> <META NAME="description" CONTENT="NIH Funding Opportunities and Notices in the NIH Guide for Grants and Contracts: Perception and Cognition Research to Inform Cancer Image Interpretation (R01 Clinical Trial Optional) PAR-19-387. NCI"> <META NAME="Keywords" CONTENT="PAR-19-387: Perception and Cognition Research to Inform Cancer Image Interpretation (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 > <div> <div id="page-title" class="heading1">Department of Health and Human Services</div> </br>  </div> </div>  <div> <a name="_Part_1._Overview"></a> <h1 class="Heading1">Part 1. Overview Information</h1> </div> <div class="row"> <div class="col-md-4 datalabel"> Participating Organization(s) </div> <div class="col-md-8 datacolumn"> National Institutes of Health (<a href="http://www.nih.gov">NIH</a>)  <p></p>  </div>  </div>  <div class="row"> <div class="col-md-4 datalabel"> Components of Participating Organizations </div> <div class="col-md-8 datacolumn"> National Cancer Institute (<a href="https://www.cancer.gov/" target="_blank">NCI</a>) <p>National Institute of Biomedical Imaging and Bioengineering (<a href="https://www.nibib.nih.gov/" target="_blank">NIBIB</a>)  <p></p>  </div>  </div>  <div class="row"> <div class="col-md-4 datalabel"> Funding Opportunity Title </div> <div class="col-md-8 datacolumn"> <span class="title">Perception and Cognition Research to Inform Cancer Image Interpretation (R01 Clinical Trial Optional)</span>  </div>  </div>  <div class="row"> <div class="col-md-4 datalabel"> Activity Code </div> <div class="col-md-8 datacolumn"> <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  </div>  </div>  <div class="row"> <div class="col-md-4 datalabel"> 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-18-640.html">PAR-18-640</a></p>  </div>  </div>  <div class="row"> <div class="col-md-4 datalabel"> 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> <b>March 10, 2020</b> - Reminder: FORMS-F Grant Application Forms & Instructions Must be Used for Due Dates On or After May 25, 2020- New Grant Application Instructions Now Available. See Notice <a href="/grants/guide/notice-files/NOT-OD-20-077.html">NOT-OD-20-077</a>. </p> July 26, 2019 - Changes to NIH Requirements Regarding Proposed Human Fetal Tissue Research. See Notice <a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-19-128.html">NOT-OD-19-128</a> </p> <p>August 23, 2019 - Clarifying Competing Application Instructions and Notice of Publication of Frequently Asked Questions (FAQs) Regarding Proposed Human Fetal Tissue Research. See Notice <a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-19-137.html">NOT-OD-19-137</a>  </div>  </div>  <div class="row"> <div class="col-md-4 datalabel"> Funding Opportunity Announcement (FOA) Number </div> <div class="col-md-8 datacolumn"> <span class="noticenum">PAR-19-387</span>  </div>  </div>  <div class="row"> <div class="col-md-4 datalabel"> Companion Funding Opportunity </div> <div class="col-md-8 datacolumn"> <p class="Normal"><a href="https://grants.nih.gov/grants/guide/pa-files/PAR-19-389.html"><u>PAR-19-389</u></a>, <a href="//grants.nih.gov/grants/funding/ac_search_results.htm?text_curr=r21&Search.x=0&Search.y=0&Search_Type=Activity">R21</a> Exploratory/Developmental Grant</p>  </div>  </div>  <div class="row"> <div class="col-md-4 datalabel"> Number of Applications </div> <div class="col-md-8 datacolumn"> See <a href="#_3._Additional_Information">Section III. 3. Additional Information on Eligibility</a>.  </div>  </div>  <div class="row"> <div class="col-md-4 datalabel"> Catalog of Federal Domestic Assistance (CFDA) Number(s) </div> <div class="col-md-8 datacolumn"> <p class="Normal">93.395; 93.394; 93.286</p>  </div>  </div>  <div class="row"> <div class="col-md-4 datalabel"> Funding Opportunity Purpose </div> <div class="col-md-8 datacolumn"> <p class="Normal">The purpose of this Funding Opportunity Announcement (FOA) is to facilitate research on the perceptual and cognitive processes underlying the performance of cancer image observers in radiology and pathology, in order to improve the accuracy of cancer detection and diagnosis.</p>  </div> </div>  <div> <a name="_Key_Dates"></a> <h2 class="Heading2">Key Dates</h2> </div> <div class="row"> <div class="col-md-4 datalabel"> Posted Date </div> <div class="col-md-8 datacolumn"> <p class="Normal">October 2, 2019</p>  </div>  </div>  <div class="row"> <div class="col-md-4 datalabel"> Open Date (Earliest Submission Date) </div> <div class="col-md-8 datacolumn"> January 05, 2020  </div>  </div>  <div class="row"> <div class="col-md-4 datalabel"> Letter of Intent Due Date(s) </div> <div class="col-md-8 datacolumn"> <p class="Normal">Not Applicable</p>  </div>  </div>  <div class="row"> <div class="col-md-4 datalabel"> Application Due Date(s) </div> <div class="col-md-8 datacolumn"> <p class="Normal" style="margin:0in 0in 0.0001pt"><a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11111">Standard dates</a> apply.</p> <p class="Normal">The first standard due date for this FOA is February 5, 2020</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"> <div class="col-md-4 datalabel"> AIDS Application Due Date(s) </div> <div class="col-md-8 datacolumn"> Not Applicable <p class="Normal" style="margin:0in 0in 0.0001pt"> </p> <p class="Normal" style="margin:0in 0in 0.0001pt"> </p> <p class="Normal" style="margin:0in 0in 0.0001pt"> </p>  </div>  </div>  <div class="row"> <div class="col-md-4 datalabel"> 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"> <div class="col-md-4 datalabel"> 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"> <div class="col-md-4 datalabel"> 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"> <div class="col-md-4 datalabel"> Expiration Date </div> <div class="col-md-8 datacolumn"> January 08, 2023  </div>  </div>  <div class="row"> <div class="col-md-4 datalabel"> Due Dates for E.O. 12372 </div> <div class="col-md-8 datacolumn"> Not Applicable  </div> </div>  <div class="heading4 " > Required Application Instructions </div> <div> 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> </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">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> <a name="_Part_2._Full"></a> <h1 class="Heading1">Part 2. Full Text of Announcement</h1> </div>  <div> <a name="_Section_I._Funding"></a> <h2 class="Heading2">Section I. Funding Opportunity Description</h2> </div>  <div> <p class="Normal"><strong style="font-size: 12pt;">Purpose</strong></p> <p class="Normal">The purpose of this </span>FOA is to facilitate research on the perceptual and cognitive processes underlying the performance of cancer image observers. Specifically, the FOA will bring scientists with expertise in visual perception and cognition together with radiologists, pathologists, nuclear medicine physicians, and other experts in cancer image interpretation. The scientific scope of the PAR will yield insights to improve the accuracy of cancer detection and diagnosis as a result of NCI's investment in studying the underlying perceptual and cognitive processes.</p> <p class="Normal">This FOA runs in parallel with an FOA of similar scientific scope, <a href="https://grants.nih.gov/grants/guide/pa-files/PAR-19-389.html">PAR-19-389</a>, which utilizes the Exploratory/Developmental Grant (R21) mechanism.</p> <p class="heading4">Background and Rationale</p> <p class="Normal"><em><strong>Challenges in Cancer Image  </span> Interpretation</strong></em></p> <p class="Normal">Despite technical advances in many areas of diagnostic imaging, the detection and diagnosis of cancer via imaging remains fallible. For example, data from the Breast Cancer Surveillance Consortium show false-negative rates of approximately 15% and false-positive rates of 10% for mammography. For lung cancer screening via computed tomography (CT) and chest radiography, false-negative rates have been reported to be as high as 39% and 70% respectively, with false-positive rates of 23% and 7%. While some of these errors may be due to technical issues or limitations of contemporary imaging technologies, a large proportion are attributable </span>  to </span>limitations of the perceptual and cognitive faculties of the clinicians and other specialists who diagnose, stage, and treat cancer. Perceptual and cognitive errors account for 60-70% of diagnostic error in radiology, and the majority of errors in breast and lung cancer diagnosis. The interpretation of a given case varies between different radiologists, and within the same radiologist at different times. Similar findings have been reported for cancer diagnoses in pathology and cytology, though the problem is understudied. While some sources of perceptual and cognitive errors have been identified (e.g., low prevalence, subsequent search misses). In other words, errors in cancer image interpretation are still largely unexplained. Research in perception and cognition will uncover important factors that influence how observers perceive, remember, learn, and act upon the images they view.</span> </span></p> <p class="Normal">We are in a period of rapid technological development in medical imaging. Conventional two-dimensional (2D) radiology is rapidly being supplanted by newer imaging techniques [e.g., computerized tomography (CT), magnetic resonance imaging (MRI)</span> </span>  </span>, and tomosynthesis] that provide three-dimensional (3D), or volumetric information about anatomical structure. However, interpretation of 3D medical images is slower and more arduous than 2D image interpretation. By understanding the perceptual processes that underlie how humans perceive 3D shape from 2D information, we may be able to develop and evaluate new techniques for presenting volumetric information. Similar problems are posed by a range of novel molecular imaging techniques coming into use. These techniques involve molecular probes or tracers that allow visualization of the distribution of the molecule of interest throughout the body. For example, imaging the uptake of an androgen receptor with a combination of CT and PET can reveal the location of prostate tumors. Unfortunately, the perceptual and cognitive aspects of using molecular imaging have been largely ignored.</p> <p class="Normal"><em><strong>What is needed</strong></em></p> <p class="Normal">No matter how sophisticated our imaging technologies become, we still rely on human observers to make the final decision. It is thus critical to understand how radiologists, pathologists, and other cancer image observers process and interact with the images they are called upon to interpret. Progress in addressing these challenges will require interdisciplinary collaboration. An effective program for solving major problems in cancer image perception will require radiologists, pathologists, cytologists, nuclear medicine physicians and other cancer image specialists to collaborate with medical image perception researchers, cognitive psychologists, computer scientists, neuroscientists, and other basic researchers with expertise in image interpretation.</p> <p class="Normal">In particular, a successful research program will involve a cyclic interaction between the clinical context and the basic research environment. The research program should identify a critical problem in cancer image perception, studies the underlying perceptual or cognitive mechanisms in a basic laboratory setting, and tests only the most promising hypotheses in the applied cancer imaging context. Differences between the laboratory and clinical findings can then inform the next round.</p> <p class="Normal">Basic research laboratories have the capacity to use highly controlled, synthetic stimuli that can be generated at will, and non-expert observers can be easily recruited at low cost</span> </span>  </span>, relative to professional cancer image interpretation specialists. This allows a perceptual laboratory to test a large number of hypotheses with less cost than would be expended on a single cancer image perception study with expert clinicians. However, findings from such studies are not guaranteed to generalize to professional observers interpreting real images in the clinical contexts. Thus, research must be grounded in the realities of clinical practice. This interactive strategy will allow an efficient winnowing of hypotheses so as to maximize the scientific impact of studies performed in the applied cancer imaging context.</p> <p class="heading4">Specific Research Objectives</p> <p class="Normal">This FOA seeks to better understand the cognitive and perceptual processes underlying the interpretation of medical images, in order to improve the accuracy of cancer detection and diagnosis.</p> <p class="Normal">Projects suitable for this FOA will have a focus on underlying cognitive and perceptual mechanisms, rather than descriptive studies. For example, a study demonstrating the relationship between experience and interpretation accuracy would not be appropriate, but a study identifying the visual features acquired by expert observers would be appropriate. In particular, the FOA seeks to encourage research that identifies a critical problem in cancer image perception, studies the underlying perceptual or cognitive mechanisms in a basic laboratory setting, and tests the most promising hypotheses in the applied cancer imaging context.</p> <p class="Normal"><strong>This FOA is not appropriate for the development of new software tools or expert systems, </strong>but studies of how human observers interact with such systems would be appropriate.</p> <p class="Normal">Projects that address international differences in cancer image interpretation performance and methods are encouraged.</p> <p class="Normal">This FOA encourages transdisciplinary research projects that integrate expertise from diverse disciplines such as medical image perception, cognitive psychology, vision science, neuroscience, computer science, radiology, nuclear medicine, pathology, molecular imaging, and dermatology.</p> <p class="Normal"><em><strong>Consideration</strong><strong> and questions that might be addressed in this FOA could include (but are not limited to) the following:</strong></em></p> <ul> <li class="Normal"><a>While computer-aided detection (CAD) systems perform well at detecting cancer in the laboratory, the technology has not improved cancer detection in the clinic. What are the perceptual and cognitive processes underlying this failure? How can we modify the presentation of CAD information to avoid these pitfalls?</a></li> <li class="Normal">Breast density affects the detectability of cancer in mammography. Radiologists reading films find it harder to detect tumors in dense breasts than in fatty breasts. However, recent studies suggest that radiologists reading digital mammograms find it harder to detect tumors in fatty breasts. What are the perceptual processes underlying this discrepancy? What strategies can we provide to radiologists to counteract the effects of breast density?</li> <li class="Normal">Training of cancer image observers is largely ad hoc and varies from institution to institution based on how different instructors were themselves trained. A more systematic approach might facilitate training and improve the performance of cancer observers. How can we leverage the principles of perceptual learning </span>  to </span>develop systematic, evidence-based techniques for training observers to interpret cancer images?</li> <li class="Normal">Having two observers read the same case independently is known to improve the accuracy of cancer image interpretation. In basic perceptual studies, having two observers perform the task jointly improves performance more than if they work independently. Other research has shown that dividing the perceptual labor so that different observers search for different types of targets can improve search efficiency. How can these "collaborative gains" be achieved in the cancer imaging context?</li> <li class="Normal">There is a robust effect of target prevalence (how often targets are encountered) in basic perception studies; rare targets are more difficult to find. This effect has now been definitively established in the cancer context as well, in both mammography and cervical cancer. Theoretical models of the effect of target prevalence on visual search performance have been developed. How can we leverage these models to improve the sensitivity of cancer image observers in low-prevalence environments such as screening?</li> </ul> <p class="Normal"><strong style="font-size: 10pt;">Information relevant to Specific Institutes/Centers and Agencies</strong></p> <p class="Normal"><em style="font-size: 10pt;">National Institute of Biomedical Imaging and Bioengineering (NIBIB): </em><em style="font-size: 10pt;">NIBIB has interest in perception and cognition research, with a focus on the development of new technologies and methodologies.</em></p> <p class="Normal"><strong>Specific areas of interest in perception and cognition research include, but are not limited to:</strong></p> <ul> <li class="Normal">Perception of multidimensional data, including in the spectral domain;</li> <li class="Normal">Augmented reality systems and advanced imaging displays;</li> <li class="Normal">Mobile systems within constrained environments;</li> <li class="Normal">Optimization of images for machine intelligence versus human perception;</li> <li class="Normal">Developing ideal observers for humans versus machine intelligence systems, including virtual observers;</li> <li class="Normal">Image quality metrics for computers versus humans;</li> <li class="Normal">Low dose radiation and image perception (i.e. sparsity levels of image quality for image perception by computers versus humans).</li> </ul> <p class="Normal"><i>NOTE: </i>For this FOA, for those applications proposing research involving clinical trials, NIBIB will only support applications proposing early-stage clinical trials through Phase I, first-in-human, safety, feasibility, or other small clinical trials that inform the early-stage technology development in the submitted application. NIBIB will not support applications proposing Phase II, III, IV or pivotal clinical trials, or trials in which the primary outcome is efficacy, effectiveness, or a post-market concern.</p> <p class="Normal">Applicants are strongly encouraged to contact the NIBIB Scientific Contact listed in this FOA for guidance in advance of submitting an application that includes human subjects research to ensure their proposed project is in compliance with new NIH human subjects research and clinical trials policies (<a href="https://grants.nih.gov/policy/clinical-trials.htm">https://grants.nih.gov/policy/clinical-trials.htm</a>) and consistent with the types of clinical trial applications that NIBIB supports.</p> </div>  <div> See <a href="#_Section_VIII._Other">Section VIII. Other Information</a> for award authorities and regulations. </div>  <div> <a name="_Section_II._Award_1"></a> <h2 class="Heading2">Section II. Award Information</h2> </div> <div class="row"> <div class="col-md-4 datalabel"> 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"> <div class="col-md-4 datalabel"> Application Types Allowed </div> <div class="col-md-8 datacolumn"> New<br/> Renewal<br/> Resubmission  <p></p>  <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"> <div class="col-md-4 datalabel"> 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"> <div class="col-md-4 datalabel"> 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"> <div class="col-md-4 datalabel"> 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"> <div class="col-md-4 datalabel"> 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> 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. </div>  <div> <a name="_Section_III._Eligibility"></a> <h2 class="Heading2">Section III. Eligibility Information</h2> </div>  <div> <h4 class="Heading4">1. Eligible Applicants</h4> </div>  <div class="heading4 " > Eligible Organizations </div> <div> <p>Higher Education Institutions</p> <ul> <li>Public/State Controlled Institutions of Higher Education</li> <li>Private Institutions of Higher Education</li> </ul> <p class="Normal" style="margin-left:40px;">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: 40px;"> <li class="BulletDoubleIndent">Hispanic-serving Institutions</li> <li class="BulletDoubleIndent">Historically Black Colleges and Universities (HBCUs)</li> <li class="BulletDoubleIndent">Tribally Controlled Colleges and Universities (TCCUs)</li> <li class="BulletDoubleIndent">Alaska Native and Native Hawaiian Serving Institutions</li> <li class="BulletDoubleIndent">Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)</li> </ul> <p>Nonprofits Other Than Institutions of Higher Education</p> <ul> <li>Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)</li> <li>Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)</li> </ul> <p>For-Profit Organizations</p> <ul> <li>Small Businesses</li> <li>For-Profit Organizations (Other than Small Businesses)</li> </ul> <p>Governments</p> <ul> <li>State Governments</li> <li>County Governments</li> <li>City or Township Governments</li> <li>Special District Governments</li> <li>Indian/Native American Tribal Governments (Federally Recognized)</li> <li>Indian/Native American Tribal Governments (Other than Federally Recognized)</li> <li>Eligible Agencies of the Federal Government</li> <li>U.S. Territory or Possession</li> </ul> Other <ul> <li>Independent School Districts</li> <li>Public Housing Authorities/Indian Housing Authorities</li> <li>Native American Tribal Organizations (other than Federally recognized tribal governments)</li> <li>Faith-based or Community-based Organizations</li> <li>Regional Organizations</li> <li>Non-domestic (non-U.S.) Entities (Foreign Institutions)</li> </ul> </div>   <div class="heading4 " > Foreign Institutions </div>  <div> Non-domestic (non-U.S.) Entities (Foreign Institutions) <strong>are </strong>eligible to apply </div>  <div> Non-domestic (non-U.S.) components of U.S. Organizations <strong>are </strong>eligible to apply. </div>  <div> 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 </strong>allowed.  </div>  <div class="heading4 " > Required Registrations </div> <div> <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 " > Eligible Individuals (Program Director/Principal Investigator) </div> <div> 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. </div>   <div> <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> <h4 class="Heading4"><a name="_3._Additional_Information"></a>3. Additional Information on Eligibility</h4> <p> <label class="heading4">Number of Applications</label>  </p> </div>  <div> Applicant organizations may submit more than one application, provided that each application is scientifically distinct. <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>A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.</li> <li>A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.</li> <li>An application that has substantial overlap with another application pending appeal of initial peer review (see <a href="//grants.nih.gov/grants/guide/notice-files/NOT-OD-11-101.html">NOT-OD-11-101</a>)</li> </ul> </div>   <div> <a name="_Section_IV._Application_1"></a> <h2 class="Heading2">Section IV. Application and Submission Information</h2> </div>  <div> <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> <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> <p class="Normal"> <normal class="Normal"> <label class="heading4">Letter of Intent</label>  </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 class="Normal">Todd S. Horowitz, Ph.D.<br /> National Cancer Institute (NCI)<br> Telephone: 240-276-6963 <br /> Email: <a href="/cdn-cgi/l/email-protection#ec98838888c284839e839b859896ac818d8580c2828584c28b839a"><span class="__cf_email__" data-cfemail="fc88939898d294938e938b958886bc919d9590d2929594d29b938a">[email protected]</span></a></p> </div>  <div class="heading4 " > Page Limitations </div> <div> 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 </div>   <div class="heading4 " > Instructions for Application Submission </div> <div> 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. </div>  <div class="heading4 " > SF424(R&R) Cover </div> <div> All instructions in the SF424 (R&R) Application Guide must be followed. </div>   <div class="heading4 " > SF424(R&R) Project/Performance Site Locations </div> <div> All instructions in the SF424 (R&R) Application Guide must be followed. </div>   <div class="heading4 " > SF424(R&R) Other Project Information </div> <div> All instructions in the SF424 (R&R) Application Guide must be followed. </div>   <div class="heading4 " > SF424(R&R) Senior/Key Person Profile </div> <div> All instructions in the SF424 (R&R) Application Guide must be followed. </div>   <div> <label class="heading4">R&R or Modular Budget</label>   <p>All instructions in the SF424 (R&R) Application Guide must be followed.</p> </div>   <div class="heading4 " > R&R Subaward Budget </div> <div> All instructions in the SF424 (R&R) Application Guide must be followed. </div>   <div class="heading4 " > PHS 398 Cover Page Supplement </div> <div> All instructions in the SF424 (R&R) Application Guide must be followed. </div>   <div class="heading4 " > PHS 398 Research Plan </div> <div> All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: </div>  <div> <p class="Normal"><strong><a>Research Strategy: </a></strong> The Research Strategy should clearly describe the cyclic interaction between the clinical context and the basic research environment.</span></p> </div>  <div> <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>The following modifications also apply:</p> </div>  <div> <ul style="margin-left: 40px;"> <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 " > Appendix: </div> <div> Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide. </div>   <div class="heading4 " > PHS Human Subjects and Clinical Trials Information </div> <div> 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>If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the <strong>Study Record: PHS Human Subjects and Clinical Trials Information </strong>form or <strong>Delayed Onset Study</strong> record.</p> <p><strong>Study Record: PHS Human Subjects and Clinical Trials Information</strong></p> <p>All instructions in the SF424 (R&R) Application Guide must be followed.</p> </div>   <div> <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 class="heading4 " > PHS Assignment Request Form </div> <div> All instructions in the SF424 (R&R) Application Guide must be followed. </div>   <div> <label class="heading4">Foreign Institutions</label>   <p>Foreign (non-U.S.) institutions must follow policies described in the <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11137">NIH Grants Policy Statement</a>, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.</p> </div>  <div> <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> <h4 class="Heading4">4. Submission Dates and Times</h4> <p class="Normal"><a href="#_Part_1._Overview" style="font-family: Verdana; font-size: 10pt;">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 </span><a href="https://grants.nih.gov/grants/guide/url_redirect.html?id=82380" style="font-family: Verdana; font-size: 10pt;">Federal holiday</a> , the application deadline is automatically extended to the next business day.</span></p> <p>Organizations must submit applications to <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11128" target="_blank">Grants.gov</a> (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11123" target="_blank">eRA Commons</a>, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.</p> <p>Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.</p> <p>Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.</p> </div>  <div> <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> <h4 class="Heading4">6. Funding Restrictions</h4> <p class="Normal"> All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the </span><a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11120" style="font-family: Verdana; font-size: 10pt;">NIH Grants Policy Statement</a> .</span></p> <p>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> <h4 class="Heading4">7. Other Submission Requirements and Information</h4> <p>Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.</p> <p>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>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></span></span></span>. 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" style="color:blue; text-decoration:underline">Dealing with System Issues</a> guidance</span></span></span></span>. For assistance with application submission, contact the Application Submission Contacts in <a href="#_Section_VII._Agency">Section VII</a>.</p> <p class="Normal" style="margin-left: 40px;"><strong>Important reminders:</strong></p> <p style="margin-left: 40px;">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 style="margin-left: 40px;">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 style="margin-left: 40px;">See <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11146">more tips</a> for avoiding common errors.</p> </div>  <div> <p class="Normal">Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed.</p> </div>   <div> <label class="heading4">Requests of $500,000 or more for direct costs in any year</label>   <p>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 class="heading4 " > Post Submission Materials </div> <div> 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. </div>   <div> <a name="_Section_V._Application"></a> <h2 class="Heading2">Section V. Application Review Information</h2> </div>  <div> <h4 class="Heading4">1. Criteria</h4> <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> <p class="Normal">In addition, for applications involving clinical trials:</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.</span></p> </div>  <div class="heading4 " > Overall Impact </div> <div> 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). </div>  <div class="heading4 " > Scored Review Criteria </div> <div> 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. </div>  <div> <p class="Normal" style="margin-left: 40px;"> <label class="heading4Indent">Significance</label>  </p> <p class="Normal" style="margin-left: 40px;"> 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> <p class="Normal" style="margin-left: 40px;"><strong>Specific to this FOA: </strong>Whether the project address an important problem or a critical barrier to progress in the field should be evaluated relative to the current state of the field, not speculations about how the field might evolve in the future.</p> <p class="Normal" style="margin-left: 40px;"><strong>In addition, for applications involving clinical trials</strong>: Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?</p> </div>  <div> <p class="Normal" style="margin-left: 40px;"> <label class="heading4Indent">Investigator(s)</label>  </p> <p class="Normal" style="margin-left: 40px;">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> <p class="Normal" style="margin-left: 40px;"><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> <p class="Normal" style="margin-left: 40px;"> <label class="heading4Indent">Innovation</label>  </p> <p class="Normal" style="margin-left: 40px;">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> <p class="Normal" style="margin-left: 40px;"><strong>In addition, for applications involving clinical trials: </strong>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> <p style="margin-left: 40px;"> <label class="heading4Indent">Approach</label>  </p> <p style="margin-left: 40px;">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</span></span></span> ? </span></span></span>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> <p class="Normal" style="margin-left: 40px;"><a name="_Hlk11684232"><strong>Specific to this FOA:</strong> Does the research program involve a cyclic interaction between the clinical context and the basic research environment?</a></p> <p class="Normal" style="margin-left: 40px;"><strong>In addition, for applications involving clinical trials</strong>: Does the application adequately address the following, if applicable</p> <p class="Normal" style="margin-left: 40px;"><em>Study Design </em></p> <p class="Normal" style="margin-left: 40px;">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" style="margin-left: 40px;">Are potential ethical issues adequately addressed? Is the process for obtaining informed consentor 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" style="margin-left: 40px;">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" style="margin-left: 40px;"><em>Data Management and Statistical Analysis </em></p> <p class="Normal" style="margin-left: 40px;">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> <p style="margin-left: 40px;">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> <p style="margin-left: 40px;"> <label class="heading4Indent">Environment</label>  </p> <p style="margin-left: 40px;">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> <p class="Normal" style="margin-left: 40px;"><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 class="heading4 " > Additional Review Criteria </div> <div> <div>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.</div> </div>  <div> <p class="heading4Indent"> Study Timeline </span></p> <p class="Normal" style="margin-left: 40px;"><strong>Specific to applications involving clinical trials</strong></p> <p class="Normal" style="margin-left: 40px;">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? Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?</p> </div>  <div> <p class="Normal" style="margin-left: 40px;"> <label class="heading4Indent">Protections for Human Subjects</label>  </p> <p class="Normal" style="margin-left: 40px;">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: 40px;">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> <p style="margin-left: 40px;"> <label class="heading4Indent">Inclusion of Women, Minorities, and Individuals Across the Lifespan</label>  </p> <p style="margin-left: 40px;">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> <p style="margin-left: 40px;"> <label class="heading4Indent">Vertebrate Animals</label>  </p> <p style="margin-left: 40px;">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> <p style="margin-left: 40px;"> <label class="heading4Indent">Biohazards</label>  </p> <p style="margin-left: 40px;">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> <p style="margin-left: 40px;"> <label class="heading4Indent">Resubmissions</label>  </p> </div>  <div> <p style="margin-left: 40px;">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> <p style="margin-left: 40px;"> <label class="heading4Indent">Renewals</label>  </p> </div>  <div> <p style="margin-left: 40px;">For Renewals, the committee will consider the progress made in the last funding period.</p> </div>  <div> <p style="margin-left: 40px;"> <label class="heading4Indent">Revisions</label>  </p> </div>  <div> <p class="Normal" style="margin-left: 40px;">Not Applicable</p> </div>  <div class="heading4 " > Additional Review Considerations </div> <div> 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. </div>   <div> <p style="margin-left: 40px;"> <label class="heading4Indent">Applications from Foreign Organizations</label>  </p> </div>  <div> <p class="Normal" style="margin-left: 40px;">Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.</p> </div>  <div> <p class="Normal" style="margin-left: 40px;"> <label class="heading4Indent">Select Agent Research</label>  </p> <p class="Normal" style="margin-left: 40px;">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> <p style="margin-left: 40px;"> <label class="heading4Indent">Resource Sharing Plans</label>  </p> </div>  <div> <p class="Normal" style="margin-left: 40px;">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> <p class="Normal" style="margin-left: 40px;"> <label class="heading4Indent">Authentication of Key Biological and/or Chemical Resources:</label>  </p> <p class="Normal" style="margin-left: 40px;">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> <p class="Normal" style="margin-left: 40px;"> <label class="heading4Indent">Budget and Period of Support</label>  </p> <p class="Normal" style="margin-left: 40px;">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> <h4 class="Heading4">2. Review and Selection Process</h4> </div>  <div> <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, 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> As part of the scientific peer review, all applications: </div>  <div> <ul style="margin-left: 40px;"> <li>May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.</li> <li>Will receive a written critique.</li> </ul> </div>   <div> 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: 40px;"> <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> <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> <a name="_Section_VI._Award"></a> <h2 class="Heading2">Section VI. Award Administration Information</h2> </div>  <div> <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> <p class="Normal">Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.</p> <p class="Normal">ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (<a href="https://register.clinicaltrials.gov/">https://register.clinicaltrials.gov</a>). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see <a href="https://grants.nih.gov/policy/clinical-trials/reporting/index.htm">https://grants.nih.gov/policy/clinical-trials/reporting/index.htm</a></p> <p class="Normal">Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.</p> <p class="Normal">Data and Safety: Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).</p> <p class="Normal">Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).</p> <p class="Normal">Milestones: Future support of a study funded under this FOA is contingent upon adequate participant recruitment based on projected milestones.</p> </div>  <div> <h4 class="Heading4">2. Administrative and National Policy Requirements</h4> All NIH grant and cooperative agreement awards include the <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11120">NIH Grants Policy Statement</a> as part of the NoA. For these terms of award, see the <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11157">NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General</a>  and <a href="//grants.nih.gov/grants/guide/url_redirect.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 class="Normal">Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency.  HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.</p> <p class="Normal">For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see <a href="https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html" style="color:blue; text-decoration:underline">https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html</a>. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see <a href="https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html" style="color:blue; text-decoration:underline">https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html</a><a href="https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html" style="color:blue; text-decoration:underline">https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html</a>. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see <a href="https://www.hhs.gov/civil-rights/for-individuals/disability/index.html" style="color:blue; text-decoration:underline">https://www.hhs.gov/civil-rights/for-individuals/disability/index.html</a>. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at <a href="https://www.hhs.gov/ocr/about-us/contact-us/index.html" style="color:blue; text-decoration:underline">https://www.hhs.gov/ocr/about-us/contact-us/index.html</a> or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at <a href="https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53">http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53</a>.</p> <p 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 " > Cooperative Agreement Terms and Conditions of Award </div> <div> Not Applicable </div>  <div> <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> 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. </div>  <div> <a name="_Section_VII._Agency"></a> <h2 class="Heading2">Section VII. Agency Contacts</h2> </div>  <div> We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. </div>  <div class="heading4 " > Application Submission Contacts </div> <div> 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#2c6b5e4d42585f65424a436c424544024b435a"><span class="__cf_email__" data-cfemail="e7a09586899394ae898188a7898e8fc9808891">[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#99eaece9e9f6ebedd9feebf8f7edeab7fef6ef"><span class="__cf_email__" data-cfemail="fd8e888d8d928f89bd9a8f9c93898ed39a928b">[email protected]</span></a> </div>  <div class="heading4 " > Scientific/Research Contact(s) </div> <div> <p class="Normal">Todd S Horowitz, Ph.D<br /> National Cancer Institute (NCI)<br /> Telephone: 240-276-6963<br /> Email: <a href="/cdn-cgi/l/email-protection#14607b70703a7c7b667b637d606e5479757d783a7a7d7c3a737b62"><span class="__cf_email__" data-cfemail="483c272c2c6620273a273f213c32082529212466262120662f273e">[email protected]</span></a></p> <p class="Normal"><a>Behrouz Shabestari, Ph.D.<br /> National Institute of Biomedical Imaging and Bioengineering (NIBIB)<br /> Telephone: 301-451-6771<br /> Email: </a><a href="/cdn-cgi/l/email-protection#0d4f68657f627877237e656c6f687e796c7f644d636465236a627b"><span class="__cf_email__" data-cfemail="4b092e2339243e316538232a292e383f2a39220b252223652c243d">[email protected]</span></a></p> </div>  <div class="heading4 " > Peer Review Contact(s) </div> <div> <p class="Normal">Maribeth Champoux, Ph.D.<br /> Center for Scientific Review (CSR)<br /> Telephone: 301-594-3163<br /> Email: <a href="/cdn-cgi/l/email-protection#f7949f969a8798829ab7948485d9999e9fd9909881"><span class="__cf_email__" data-cfemail="caa9a2aba7baa5bfa78aa9b9b8e4a4a3a2e4ada5bc">[email protected]</span></a></p> </div>  <div class="heading4 " > Financial/Grants Management Contact(s) </div> <div> <p class="Normal"> Carol Perry</span><br> National Cancer Institute (NCI)<br> Telephone: 240-276-6282<br> Email: <a href="/cdn-cgi/l/email-protection#d3a3b6a1a1aab093beb2babffdbdbabbfdb4bca5"><span class="__cf_email__" data-cfemail="3f4f5a4d4d465c7f525e56531151565711585049">[email protected]</span></a></p> <u5:p class="Normal"> </u5:p> <p class="Normal"> Angelos Bacas</span><br> National Institute of Biomedical Imaging and Bioengineering (NIBIB)<br /> Telephone: 301-451-4782<br /> Email: <a href="/cdn-cgi/l/email-protection#1d7c7f2e2f247f5d737475337a726b"><span class="__cf_email__" data-cfemail="07666534353e6547696e6f29606871">[email protected]</span></a></p> </div>  <div> <a name="_Section_VIII._Other"></a> <h2 class="Heading2">Section VIII. Other Information</h2> </div>  <div> 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>. </div>  <div class="heading4 " > Authority and Regulations </div> <div> 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. </div>  </div> </div> </div>  </div> </div> </div> <div class="row"> <div class="col-xs-12"> <P> <HR> <A HREF="/grants/guide/WeeklyIndex.cfm?10-04-19">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="https://grants.nih.gov/grants/oer.htm" /> <area shape="rect" coords="3,5,78,55" href="https://grants.nih.gov/grants/oer.htm" /> </map> </div> <div class="col-md-4"> <div style="float:left; padding: 5 5 5 70"> <a href="https://www.hhs.gov/"><img src="/images7/dhhs_sm.gif" width="36" height="37" border="0" alt="Department of Health and Human Services (HHS) - Home Page" long desc="Logo, circular in shape, depicting an American eagle in-flight with stylized profiles of human faces appearing on the trailing edge of the wings. 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