Research Grants in Clinical Informatics (R01 Clinical Trial Optional)
National Institutes of Health
Funding Amount
$0 - $250,000
Deadline
March 5, 2029
1062 days left
Grant Type
federal
Overview
Research Grants in Clinical Informatics (R01 Clinical Trial Optional)
The National Library of Medicine (NLM) seeks applications for innovative research in clinical informatics. The overarching goal of this forthcoming program is to catalyze the development and advancement of novel informatics methodologies that empower clinicians, patients, and the broader public to better understand, manage, and improve health and health care delivery. This NOFO will support research focused on the design, implementation, and evaluation of clinical informatics tools and methods that enable data-driven discovery, promote evidence-based decision-making, and support personalized and precision health care. Emphasis will be placed on domain-independent, scalable, and reusable/reproducible approaches for the discovery, analysis, organization, and management of health-related digital objects—including electronic health records (EHRs), clinical notes, imaging data, and patient-generated data. The aim is to transform raw and heterogeneous health data into actionable knowledge, to develop innovative tools, and to implement practical applications that can be generalized across multiple clinical settings and populations. Projects should demonstrate the potential to accelerate scientific insights, improve clinical workflows, and ultimately lead to improved health outcomes.
Details
- Agency: National Institutes of Health
- Department: Department of Health and Human Services
- Opportunity #: PAR-26-042
- Total Funding: $2,500,000
- Expected Awards: 10
- Instrument: grant
Eligibility
Refer to Section III. Eligibility Information in the NOFO for additional information on eligibility.Foreign Organizations/International CollaborationsNon-domestic (non-U.S.) Entities (Foreign Organizations) are eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.Foreign components, as defined in the NIH Grants Policy Statement, are allowed.NIH will no longer issue awards (i.e., new, renewal, or non-competing continuation) to domestic or foreign entities that involve foreign subawards/subcontracts. All NIH-funded research involving foreign subawards/subcontracts must be submitted in response to a NOFO that is specifically designated for funded international collaborations. This new requirement was effective, May 1, 2025.Applications involving foreign subawards/subcontracts submitted in response to this NOFO will be deemed noncompliant and will not be considered for funding. This policy applies to all monetary international collaborations resu
Eligibility
Eligible Applicant Types
How to Apply
PAR-26-042-Full-Announcement.html
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<title>PAR-26-042: Research Grants in Clinical Informatics (R01 Clinical Trial Optional)</title>
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<div id="page-title" class="heading1" tabindex="0">Department of Health and Human Services</div>
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<a id='_bookmark261213' tabindex='-1' aria-hidden='true'></a><a name="_Part 1. Overview Information"></a><h1>Part 1. Overview Information</h1>
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<p>National Institutes of Health (<a href="http://www.nih.gov">NIH</a>)</p>
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<p>National Library of Medicine (<a href="https://www.nlm.nih.gov/" target="_blank" rel="noreferrer">NLM</a>)
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<div class="col-md-push-4 col-md-8 datacolumn">
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<a id='_bookmark261218' tabindex='-1' aria-hidden='true'></a>Funding Opportunity Title
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<span class="title">Research Grants in Clinical Informatics (R01 Clinical Trial Optional)</span>
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<a id='_bookmark261219' tabindex='-1' aria-hidden='true'></a>Activity Code
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<p><a href="http://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>
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New
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<a id='_bookmark261221' tabindex='-1' aria-hidden='true'></a>Related Notices
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<div class=" col-md-8 datacolumn">
<ul><li>Check for any recent <a href="https://grants.nih.gov/grants/guide/url_redirect.php?id=11163">Notices of NIH Policy Changes</a> that may impact application requirements.</li></ul>
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<a id='_bookmark261222' tabindex='-1' aria-hidden='true'></a>Funding Opportunity Number (FON)
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<span class="noticenum">PAR-26-042</span>
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None
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<p>See Part 2, Section III. 3. Additional Information on Eligibility.</p>
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93.879
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<a id='_bookmark261226' tabindex='-1' aria-hidden='true'></a>Funding Opportunity Purpose
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<p>The National Library of Medicine (NLM) seeks applications for innovative research in clinical informatics. The overarching goal of this forthcoming program is to catalyze the development and advancement of novel informatics methodologies that empower clinicians, patients, and the broader public to better understand, manage, and improve health and health care delivery. This NOFO will support research focused on the design, implementation, and evaluation of clinical informatics tools and methods that enable data-driven discovery, promote evidence-based decision-making, and support personalized and precision health care. Emphasis will be placed on domain-independent, scalable, and reusable/reproducible approaches for the discovery, analysis, organization, and management of health-related digital objects—including electronic health records (EHRs), clinical notes, imaging data, and patient-generated data. The aim is to transform raw and heterogeneous health data into actionable knowledge, to develop innovative tools, and to implement practical applications that can be generalized across multiple clinical settings and populations. Projects should demonstrate the potential to accelerate scientific insights, improve clinical workflows, and ultimately lead to improved health outcomes.</p>
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<a id='_bookmark261228' tabindex='-1' aria-hidden='true'></a>Funding Opportunity Goal(s)
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<p>To facilitate management of electronic health records and clinical research data.</p>
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<a id='_bookmark261229' tabindex='-1' aria-hidden='true'></a><a name="_Key Dates"></a><h2>Key Dates</h2>
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February 11, 2026
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April 06, 2026
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The following table includes NIH <a href="https://grants.nih.gov/grants/how-to-apply-application-guide/due-dates-and-submission-policies/due-dates.htm" target="_blank" rel="noreferrer">standard due dates</a> marked with an asterisk.
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<th scope="col" colspan="3" style="border:2px solid #bcbcbc;" class="text-center">Review and Award Cycles</th>
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<th scope="col" style="width:16.66%;border-left:2px solid #bcbcbc;" class="text-center">New</th>
<th scope="col" style="width:16.66%" class="text-center">Renewal / Resubmission / Revision (as allowed)</th>
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June 05, 2026 *
</td>
<td>
July 05, 2026 *
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<td>
Not Applicable
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<td>November 2026</td>
<td> January 2027
</td>
<td>April 2027</td>
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<tr>
<td>
October 05, 2026 *
</td>
<td>
November 05, 2026 *
</td>
<td>
Not Applicable
</td>
<td>March 2027</td>
<td> May 2027
</td>
<td>July 2027</td>
</tr>
<tr>
<td>
February 05, 2027 *
</td>
<td>
March 05, 2027 *
</td>
<td>
Not Applicable
</td>
<td>July 2027</td>
<td> October 2027
</td>
<td>December 2027</td>
</tr>
<tr>
<td>
June 05, 2027 *
</td>
<td>
July 05, 2027 *
</td>
<td>
Not Applicable
</td>
<td>November 2027</td>
<td> January 2028
</td>
<td>April 2028</td>
</tr>
<tr>
<td>
October 05, 2027 *
</td>
<td>
November 05, 2027 *
</td>
<td>
Not Applicable
</td>
<td>March 2028</td>
<td> May 2028
</td>
<td>July 2028</td>
</tr>
<tr>
<td>
February 05, 2028 *
</td>
<td>
March 05, 2028 *
</td>
<td>
Not Applicable
</td>
<td>July 2028</td>
<td> October 2028
</td>
<td>December 2028</td>
</tr>
<tr>
<td>
June 05, 2028 *
</td>
<td>
July 05, 2028 *
</td>
<td>
Not Applicable
</td>
<td>November 2028</td>
<td> January 2029
</td>
<td>April 2029</td>
</tr>
<tr>
<td>
October 05, 2028 *
</td>
<td>
November 05, 2028 *
</td>
<td>
Not Applicable
</td>
<td>March 2029</td>
<td> May 2029
</td>
<td>July 2029</td>
</tr>
<tr>
<td>
February 05, 2029 *
</td>
<td>
March 05, 2029 *
</td>
<td>
Not Applicable
</td>
<td>July 2029</td>
<td> October 2029
</td>
<td>December 2029</td>
</tr>
</tbody>
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<a id='_bookmark261235' tabindex='-1' aria-hidden='true'></a><p>All applications are due by 5:00 PM local time of applicant organization. </p>
<p>Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.</p>
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<a id='_bookmark261241' tabindex='-1' aria-hidden='true'></a>Due Dates for E.O. 12372
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<p>Not Applicable</p>
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March 06, 2029
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<p>It is critical that applicants follow the instructions in the Research (R) Instructions in the <a href="https://grants.nih.gov/grants/guide/url_redirect.htm?id=82400">How to Apply - Application Guide</a>, except where instructed to do otherwise (in this NOFO or in a Notice from <a href="http://grants.nih.gov/grants/guide/url_redirect.htm?id=11164">NIH Guide for Grants and Contracts</a>).</p>
<p>Conformance to all requirements (both in the Application Guide and the NOFO) 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 Section IV. 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>
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<a id='_bookmark262235' tabindex='-1' aria-hidden='true'></a><p style="margin-left:0in;">There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You <strong>must</strong> use one of these submission options to access the application forms for this opportunity.</p><ol><li>Use the <a href="https://public.era.nih.gov/assist/landing.era?tabId=0819b5fc-46b7-4f02-b6b7-127e5a4e19fa">NIH ASSIST system</a> to prepare, submit and track your application online.</li><li>Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and <a href="https://public.era.nih.gov/commons/">eRA Commons</a> to track your application. Check with your institutional officials regarding availability.</li><li>Use <a href="https://grants.gov/search-grants?oppStatuses=closed|archived|posted|forecasted&fon=PA-25-301">Grants.gov</a> Workspace to prepare and submit your application and <a href="http://public.era.nih.gov/commons/">eRA Commons</a> to track your application.</li></ol>
</div>
<div id="tocDiv">
<div class="heading1" tabindex="0">Table of Contents</div>
<div class="toc-link"><a href="#_Part%201.%20Overview%20Information">Part 1. Overview Information</a></div><div class="toc-link P_SingleIndent"><a href="#_Key%20Dates">Key Dates</a></div><div class="toc-link"><a href="#_Part%202.%20Full%20Text%20of%20Announcement">Part 2. Full Text of Announcement</a></div><div class="toc-link P_SingleIndent"><a href="#_Section%20I.%20Notice%20of%20Funding%20Opportunity%20Description">Section I. Notice of Funding Opportunity Description</a></div><div class="toc-link P_SingleIndent"><a href="#_Section%20II.%20Award%20Information">Section II. Award Information</a></div><div class="toc-link P_SingleIndent"><a href="#_Section%20III.%20Eligibility%20Information">Section III. Eligibility Information</a></div><div class="toc-link P_SingleIndent"><a href="#_Section%20IV.%20Application%20and%20Submission%20Information">Section IV. Application and Submission Information</a></div><div class="toc-link P_SingleIndent"><a href="#_Section%20V.%20Application%20Review%20Information">Section V. Application Review Information</a></div><div class="toc-link P_SingleIndent"><a href="#_Section%20VI.%20Award%20Administration%20Information">Section VI. Award Administration Information</a></div><div class="toc-link P_SingleIndent"><a href="#_Section%20VII.%20Agency%20Contacts">Section VII. Agency Contacts</a></div><div class="toc-link P_SingleIndent"><a href="#_Section%20VIII.%20Other%20Information">Section VIII. Other Information</a></div>
</div><br/>
<div data-element-id="261245" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="FOD" data-element-type="TEXT">
<a id='_bookmark261245' tabindex='-1' aria-hidden='true'></a><a name="_Part 2. Full Text of Announcement"></a><h1>Part 2. Full Text of Announcement</h1>
</div>
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<a id='_bookmark261246' tabindex='-1' aria-hidden='true'></a><a name="_Section I. Notice of Funding Opportunity Description"></a><h2>Section I. Notice of Funding Opportunity Description</h2>
</div>
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<a id='_bookmark261247' tabindex='-1' aria-hidden='true'></a><p>Clinical informatics sits at the intersection of healthcare, information science, and technology, offering critical tools and approaches to improve patient care, advance clinical practice, and inform decision-making. As the healthcare landscape continues to generate vast volumes of complex data, there is a growing need for innovative informatics solutions that can turn data into actionable knowledge. The National Library of Medicine (NLM) supports research that transforms health data into meaningful knowledge to improve health outcomes and enhance decision-making. Specifically, this NOFO aligns with NLM’s commitment to accelerating discovery and advancing health through data-driven research. By supporting clinical informatics research, NLM aims to catalyze the development of scalable, interoperable, and data-driven methods that enable better diagnosis, treatment, and prevention strategies across clinical settings.</p><p>NLM’s clinical informatics research portfolio has historically spanned a broad range of topics, including artificial intelligence, clinical decision support, medical language processing, biomedical imaging, and large-scale analysis of clinical data to improve health and drive discovery. Through this work, NLM has funded innovative research that accelerates data-driven discovery, translates findings into clinical solutions, and empowers individuals to better understand and manage their health data. With this new initiative, NLM seeks bold, forward-looking projects in clinical informatics that develop novel, generalizable methods for transforming complex health data into usable knowledge and supporting decision-making. Applications submitted under this announcement should emphasize domain-independent, scalable, and reusable approaches for the discovery, analysis, organization, and management of health-related data and digital objects.</p><p>The overarching goal of this initiative is to advance the development of innovative informatics solutions that enable both healthcare providers and individuals to better understand and improve overall health. </p><p>Research questions and topics of interest under this program are envisioned to include but are not limited to:</p><ul><li>Tools to assess information and knowledge needs of health care professionals and patients.</li><li>Building & leveraging next-gen CDSS (Clinical Decision Support Systems), comprehensive patient-centric digital tools that promote precision medicine.</li><li>Research on EHR usability, interoperability, and tools to streamline clinical documentation while reducing clinician burden and improving patient care.</li><li>Predictive analytics for proactive care/preventative care - including models that identify at-risk patients and in real time to recommend timely interventions.</li><li>Transformative methods in data integration - research topics that include innovation approaches to harmonizing diverse data streams and exploring advanced techniques that can be implemented in a practical manner.</li><li>AI tools and methods with a focus on benefits to patients and health systems/workflow, patient satisfaction, costs, operational efficiency.</li><li>Research to improve quality and outcomes of patient care, for example, for enabling clinicians to monitor patients' conditions for changes or detect undiagnosed diseases earlier.</li><li>Automate administrative processes and reduce workforce burden and burnout.</li></ul><p><strong>Research Objectives</strong></p><p>Research approaches should foster data-driven discovery to accomplish NLM mission-related goals. Additionally, the following expectations should be addressed in all applications:</p><ul><li>Research should exemplify scientific rigor, feasibility, technological innovation, and the potential for significant impact across biomedical and clinical domains.</li><li>Outputs should be transformative and generalizable across diseases and biological systems; use of specific biological systems may be permissible for proof-of-concept and initial methodology development, but applicants must demonstrate broad applicability beyond that.</li><li>Products should be durable with the potential to inform and advance further research.</li><li>Intended use cases must be clearly stated and evaluated, with approaches expected to be wide-reaching.</li><li>Detailed descriptions of approaches are expected, with metrics provided for the scope and scale of the study.</li><li>Improvements over comparable existing approaches must be documented, and any limitations, trade-offs or risks resulting from the proposed innovative approach must be described and addressed.</li><li>Applicants must describe a plan to account for accuracy of the product(s), to maintain the product(s), and to capture and communicate considerations for downstream use.</li><li>All awardees are expected to widely disseminate the results of their research, including software products, datasets, resources and platforms.</li><li>For applications that incorporate the aggregation of public or non-controlled-access data, applicants are expected to address methods for mitigating privacy concerns that may arise from such aggregated data. Privacy protections for human subjects are expected to be long-term and must extend beyond the funding period.</li></ul><p><strong>Applications Not Responsive to this NOFO</strong></p><p>The following types of projects will be considered non-responsive to the scope of NLM’s Research Grants in Clinical Informatics program:</p><ul><li>Projects that do not align with current NIH or Department of Health and Human Services priorities, including projects that partially incorporate non-aligning activities.</li><li>Projects not centrally focused on, or not clearly pertaining to, clinical informatics.</li><li>Projects focused on social determinants of health (SDOH), or ethical, legal and social issues (ELSI).</li><li>Projects that duplicate NLM products and databases.</li><li>Projects that do not produce open-access datasets, methods, resources or tools.</li><li>Projects focused on mere incremental improvements of, or on the maintenance of, existing tools, resources or platforms; significant innovation and advancement is expected from this initiative.</li><li>Projects with most of the effort devoted to experimental research; only a small portion of the budget may be permitted for experimental validation of computational approaches.</li><li>Projects narrowly focused on specific diseases and with limited potential to yield broadly applicable tools.</li></ul><p>Non-responsive applications will not be reviewed. Potential applicants are strongly encouraged to discuss their proposed project with the Scientific/Research Contacts listed in Section VII for guidance about the application process and suitability of the project for support by NLM.</p>
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<a id='_bookmark261249' tabindex='-1' aria-hidden='true'></a><p>Investigators proposing NIH-defined clinical trials may refer to the <a href="https://researchmethodsresources.nih.gov/">Research Methods Resources</a> website for information about developing statistical methods and study designs.</p>
</div>
<div data-element-id="261250" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="FOD" data-element-type="TEXT">
<a id='_bookmark261250' tabindex='-1' aria-hidden='true'></a><p>See Section VIII. Other Information for award authorities and regulations.</p>
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<a id='_bookmark261251' tabindex='-1' aria-hidden='true'></a><a name="_Section II. Award Information"></a><h2>Section II. Award Information</h2>
</div>
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<a id='_bookmark261252' tabindex='-1' aria-hidden='true'></a>Funding Instrument
</div>
<div class=" col-md-8 datacolumn">
<p>Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.</p>
</div>
</div>
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<div class="col-md-4 datalabel" tabindex="0" data-element-id="261253" data-element-required="true" data-element-has-value="true" data-section-code="AI" data-element-type="LINKED_ELEMENT">
<a id='_bookmark261253' tabindex='-1' aria-hidden='true'></a> Application Types Allowed
</div>
<div class=" col-md-8 datacolumn">
New
<br>
Renewal
<br>
Resubmission
<br>
Revision
<br>
</div>
</div>
<div class="row" data-index="43">
<div class="col-md-push-4 col-md-8 datacolumn">
<a id='_bookmark261255' tabindex='-1' aria-hidden='true'></a><p>The <a href="http://grants.nih.gov/grants/guide/url_redirect.htm?id=11116">OER Glossary</a> and the How to Apply Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.</p>
</div>
</div>
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<div class="col-md-4 datalabel" tabindex="0" data-element-id="261256" data-element-required="false" data-element-has-value="true" data-section-code="AI" data-element-type="TEXT">
<a id='_bookmark261256' tabindex='-1' aria-hidden='true'></a>Clinical Trial?
</div>
<div class=" col-md-8 datacolumn">
<p>Optional: Accepting applications that either propose or do not propose clinical trial(s).</p>
</div>
</div>
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<div class="col-md-push-4 col-md-8 datacolumn">
<a id='_bookmark261257' tabindex='-1' aria-hidden='true'></a><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>
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<div class="col-md-4 datalabel" tabindex="0" data-element-id="261258" data-element-required="true" data-element-has-value="true" data-section-code="AI" data-element-type="TEXT">
<a id='_bookmark261258' tabindex='-1' aria-hidden='true'></a>Funds Available and Anticipated Number of Awards
</div>
<div class=" col-md-8 datacolumn">
<p>The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.</p>
</div>
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<div class="col-md-4 datalabel" tabindex="0" data-element-id="261259" data-element-required="true" data-element-has-value="true" data-section-code="AI" data-element-type="TEXT">
<a id='_bookmark261259' tabindex='-1' aria-hidden='true'></a>Award Budget
</div>
<div class=" col-md-8 datacolumn">
<p>Application budgets are limited to $250,000 per year in direct costs and need to reflect the actual needs of the proposed project.</p>
</div>
</div>
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<div class="col-md-4 datalabel" tabindex="0" data-element-id="261260" data-element-required="true" data-element-has-value="true" data-section-code="AI" data-element-type="TEXT">
<a id='_bookmark261260' tabindex='-1' aria-hidden='true'></a>Award Project Period
</div>
<div class=" col-md-8 datacolumn">
<p>The scope of the proposed project should determine the project period. The maximum project period is 4 years. </p>
</div>
</div>
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<div data-element-id="261261" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="AI" data-element-type="TEXT">
<a id='_bookmark261261' tabindex='-1' aria-hidden='true'></a><p>NIH grants policies as described in the <a href="http://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 NOFO.</p>
</div>
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<a id='_bookmark261262' tabindex='-1' aria-hidden='true'></a><a name="_Section III. Eligibility Information"></a><h2>Section III. Eligibility Information</h2>
</div>
<div data-element-id="261263" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="EI" data-element-type="TEXT">
<a id='_bookmark261263' tabindex='-1' aria-hidden='true'></a><h4>1. Eligible Applicants</p>
</div>
<div class="heading4" tabindex="0" data-element-id="261264" data-element-required="true" data-element-has-value="true" data-section-code="EI" data-element-type="TEXT">
<a id='_bookmark261264' tabindex='-1' aria-hidden='true'></a>Eligible Organizations
</div>
<div data-element-id="261264" data-element-has-label="true" data-element-required="true" data-element-has-value="true" data-section-code="EI" data-element-type="TEXT">
<p>Higher Education Institutions - Includes all types</p><ul><li>Public/State Controlled Institutions of Higher Education</li><li>Private Institutions of Higher Education</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>Local 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></ul>
</div>
<div data-element-id="261265" data-element-has-label="false" data-element-required="false" data-element-has-value="true" data-section-code="EI" data-element-type="TEXT">
<a id='_bookmark261265' tabindex='-1' aria-hidden='true'></a><p>Federal Governments</p>
<ul>
<li>Eligible Agencies of the Federal Government</li>
<li>U.S. Territory or Possession</li>
</ul>
</div>
<div data-element-id="261266" data-element-has-label="false" data-element-required="false" data-element-has-value="true" data-section-code="EI" data-element-type="TEXT">
<a id='_bookmark261266' tabindex='-1' aria-hidden='true'></a><p>Other</p>
<ul>
<li>Independent School Districts</li>
<li>Public Housing Authorities/Indian Housing Authorities</li>
<li>Native American Tribal Organizations (other than Federally recognized tribal governments)</li>
<li>Faith-based or Community-based Organizations</li>
<li>Regional Organizations</li>
<li>Non-domestic (non-U.S.) Entities (Foreign Organizations)</li>
</ul>
</div>
<div data-element-id="261267" data-element-has-label="false" data-element-required="false" data-element-has-value="true" data-section-code="EI" data-element-type="TEXT">
<a id='_bookmark261267' tabindex='-1' aria-hidden='true'></a><p><strong>Foreign Organizations/ International Collaborations</strong></p><p>NIH will no longer issue awards (new, renewal, or non-competing continuation) to domestic or foreign entities that involve foreign subawards/subcontracts. All NIH-funded research involving foreign subawards/subcontracts must be submitted in response to a NOFO that is specifically designated for funded international collaborations. This new requirement was effective, May 1, 2025.</p><p>Applications involving foreign subawards/subcontracts submitted in response to this NOFO will be deemed noncompliant and will not be considered for funding. This policy applies to all monetary international collaborations resulting in foreign subawards/subcontracts, however, it does not preclude unfunded international collaborations or <a href="https://grants.nih.gov/grants/policy/nihgps/HTML5/section_1/1.2_definition_of_terms.htm">foreign components</a>, funding for foreign consultants, or procurement of unique equipment or supplies from foreign vendors.</p>
</div>
<div data-element-id="261268" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="EI" data-element-type="TEXT">
<a id='_bookmark261268' tabindex='-1' aria-hidden='true'></a><h4>Foreign Organizations/International Collaborations</h4>
</div>
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<a id='_bookmark261269' tabindex='-1' aria-hidden='true'></a><p class="Normal">Non-domestic (non-U.S.) Entities (Foreign Organizations) <strong>are </strong>eligible to apply.</p>
</div>
<div data-element-id="261270" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="EI" data-element-type="RADIO_BUTTON">
<a id='_bookmark261270' tabindex='-1' aria-hidden='true'></a><p>Non-domestic (non-U.S.) components of U.S. Organizations <strong>are </strong>eligible to apply.</p>
</div>
<div data-element-id="261271" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="EI" data-element-type="RADIO_BUTTON">
<a id='_bookmark261271' tabindex='-1' aria-hidden='true'></a><p class="Normal">Foreign components, as <a href="http://grants.nih.gov/grants/guide/url_redirect.htm?id=11118">defined in the NIH Grants Policy Statement</a>, <b>are </b>allowed.</p>
</div>
<div data-element-id="262147" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="EI" data-element-type="TEXT">
<a id='_bookmark262147' tabindex='-1' aria-hidden='true'></a><p>NIH will no longer issue awards (i.e., new, renewal, or non-competing continuation) to domestic or foreign entities that involve foreign subawards/subcontracts. All NIH-funded research involving foreign subawards/subcontracts must be submitted in response to a NOFO that is specifically designated for funded international collaborations. This new requirement was effective, May 1, 2025.</p><p>Applications involving foreign subawards/subcontracts submitted in response to this NOFO will be deemed noncompliant and will not be considered for funding. This policy applies to all monetary international collaborations resulting in foreign subawards/subcontracts, however, it does not preclude unfunded international collaborations or <a href="https://grants.nih.gov/grants/policy/nihgps/HTML5/section_1/1.2_definition_of_terms.htm">foreign components</a>, funding for foreign consultants, or procurement of unique equipment or supplies from foreign vendors.</p>
</div>
<div class="heading4" tabindex="0" data-element-id="261272" data-element-required="true" data-element-has-value="true" data-section-code="EI" data-element-type="TEXT">
<a id='_bookmark261272' tabindex='-1' aria-hidden='true'></a>Required Registrations
</div>
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<p><strong>Applicant Organizations</strong></p>
<p>Applicant organizations must complete and maintain the following registrations as described in the How to Apply- 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference the <a href="http://grants.nih.gov/grants/guide/url_redirect.htm?id=82423">NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications</a> for additional information.</p>
<ul>
<li><a href="https://grants.nih.gov/grants/guide/url_redirect.htm?id=82390">System for Award Management (SAM) –</a> Applicants must complete and maintain an active registration, <strong>which requires renewal at least annually</strong>. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
<ul>
<li><a href="http://grants.nih.gov/grants/guide/url_redirect.htm?id=11176">NATO Commercial and Government Entity (NCAGE) Code</a> – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.</li>
<li>Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.</li>
</ul>
</li>
<li><a href="https://grants.nih.gov/grants/guide/url_redirect.htm?id=11123">eRA Commons</a> - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.</li>
<li><a href="http://grants.nih.gov/grants/guide/url_redirect.htm?id=82300">Grants.gov</a> – Applicants must have an active SAM registration in order to complete the Grants.gov registration.</li>
</ul>
<p><strong>Program Directors/Principal Investigators (PD(s)/PI(s))</strong></p>
<p>All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.</p>
</div>
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<a id='_bookmark261273' tabindex='-1' aria-hidden='true'></a>Eligible Individuals (Program Director/Principal Investigator)
</div>
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<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 their organization to develop an application for 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 How to Apply-Application Guide.</p>
</div>
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<a id='_bookmark261275' tabindex='-1' aria-hidden='true'></a><h4>2. Cost Sharing</h4><p>This NOFO does not require cost sharing as defined in the <a href="http://grants.nih.gov/grants/guide/url_redirect.htm?id=11126">NIH Grants Policy Statement Section 1.2 Definition of Terms</a>.</p>
</div>
<div data-element-id="261276" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="EI" data-element-type="TEXT">
<a id='_bookmark261276' tabindex='-1' aria-hidden='true'></a><h4>3. Additional Information on Eligibility</h4><p>Number of Applications</p>
</div>
<div data-element-id="261277" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="EI" data-element-type="TEXT">
<a id='_bookmark261277' tabindex='-1' aria-hidden='true'></a><p>Applicant organizations may submit more than one application, provided that each application is scientifically distinct.</p>
<p>The NIH will not accept duplicate or highly overlapping applications under review at the same time, per <a href="http://grants.nih.gov/grants/guide/url_redirect.htm?id=82415">NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application</a>. This means that the NIH will not accept:</p>
<ul>
<li>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="http://grants.
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