Single-Site Investigator-Initiated Clinical Trials (R61/R33 Clinical Trial Required)
National Institutes of Health
Funding Amount
Varies
Deadline
November 2, 2028
940 days left
Grant Type
federal
Overview
Single-Site Investigator-Initiated Clinical Trials (R61/R33 Clinical Trial Required)
This Notice of Funding Opportunity (NOFO) supports applications to develop and conduct investigator-initiated single site clinical trials including efficacy, comparative effectiveness, pragmatic and/or dissemination and implementation science clinical trials. Trials using innovative designs such as platform trials, adaptive, and Bayesian designs are encouraged. These trials may include ones that test different therapeutic, behavioral, dissemination and implementation science clinical trials and/or prevention strategies. Trials for which this NOFO applies must be relevant to the research mission of the NHLBI and meet the NIH definition of a clinical trial (see NOT-OD-15-015). For additional information about the mission, strategic vision, and research priorities of the NHLBI, applicants are encouraged to consult the NHLBI website.This NOFO will utilize a bi-phasic, milestone-driven mechanism of award. The objective of the application is to present the scientific rationale for the clinical trial and a comprehensive scientific and operational plan that describes it. The application should address project management, participant recruitment and retention, performance milestones, scientific conduct of the trial, and dissemination of results. The multiple PD/PI model is strongly encouraged but not required. Applicants are encouraged to include a PD/PI with expertise in biostatistics, clinical trial design, and coordination. The application should also describe its approaches to increase community engagement from conceptual design of the intervention through implementation and sustainability, close gaps in health outcomes within the US population, and increase health for all.
Details
- Agency: National Institutes of Health
- Department: Department of Health and Human Services
- Opportunity #: PAR-27-011
- 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-27-011-Full-Announcement.html
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<title>PAR-27-011: Single-Site Investigator-Initiated Clinical Trials (R61/R33 Clinical Trial Required)</title>
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<div id="page-title" class="heading1" tabindex="0">Department of Health and Human Services</div>
<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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<a id='_bookmark261214' tabindex='-1' aria-hidden='true'></a>Participating Organization(s)
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<p>National Institutes of Health (<a href="http://www.nih.gov">NIH</a>)</p>
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<a id='_bookmark261216' tabindex='-1' aria-hidden='true'></a>Components of Participating Organizations
</div>
<div class=" col-md-8 datacolumn">
<p>National Heart, Lung, and Blood Institute (<a href="https://www.nhlbi.nih.gov/" target="_blank" rel="noreferrer">NHLBI</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
</div>
<div class=" col-md-8 datacolumn">
<span class="title">Single-Site Investigator-Initiated Clinical Trials (R61/R33 Clinical Trial Required)</span>
</div>
</div>
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<a id='_bookmark261219' tabindex='-1' aria-hidden='true'></a>Activity Code
</div>
<div class=" col-md-8 datacolumn">
<p><a href="http://grants.nih.gov/grants/funding/ac_search_results.htm?text_curr=r61&Search.x=0&Search.y=0&Search_Type=Activity">R61</a>/<a href="http://grants.nih.gov/grants/funding/ac_search_results.htm?text_curr=r33&Search.x=0&Search.y=0&Search_Type=Activity">R33</a> Exploratory/Developmental Phased Award</p>
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<a id='_bookmark261220' tabindex='-1' aria-hidden='true'></a>Announcement Type
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<div class=" col-md-8 datacolumn">
Reissue of
PAR-25-028
<br/>
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<a id='_bookmark261221' tabindex='-1' aria-hidden='true'></a>Related Notices
</div>
<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>
</div>
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<div class="row" data-index="10">
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<a id='_bookmark261222' tabindex='-1' aria-hidden='true'></a>Funding Opportunity Number (FON)
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<div class=" col-md-8 datacolumn">
<span class="noticenum">PAR-27-011</span>
</div>
</div>
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<a id='_bookmark261223' tabindex='-1' aria-hidden='true'></a>Companion Funding Opportunity
</div>
<div class=" col-md-8 datacolumn">
None
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<div class="row" data-index="12">
<div class="col-md-4 datalabel" tabindex="0" data-element-id="261224" data-element-required="true" data-element-has-value="true" data-section-code="OI" data-element-type="TEXT">
<a id='_bookmark261224' tabindex='-1' aria-hidden='true'></a>Number of Applications
</div>
<div class=" col-md-8 datacolumn">
<p>See Section III. 3. Additional Information on Eligibility.</p>
</div>
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<a id='_bookmark261225' tabindex='-1' aria-hidden='true'></a>Assistance Listing Number(s)
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<div class=" col-md-8 datacolumn">
93.837, 93.838, 93.233, 93.840, 93.839
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<a id='_bookmark261226' tabindex='-1' aria-hidden='true'></a>Funding Opportunity Purpose
</div>
<div class=" col-md-8 datacolumn">
<p>This Notice of Funding Opportunity (NOFO) supports applications to develop and conduct investigator-initiated single site clinical trials including efficacy, comparative effectiveness, pragmatic and/or dissemination and implementation science clinical trials. Trials using innovative designs such as platform trials, adaptive, and Bayesian designs are encouraged. These trials may include ones that test different therapeutic, behavioral, dissemination and implementation science clinical trials and/or prevention strategies. Trials for which this NOFO applies must be relevant to the research mission of the NHLBI and meet the NIH definition of a clinical trial (see <a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html">NOT-OD-15-015</a>). For additional information about the mission, strategic vision, and research priorities of the NHLBI, applicants are encouraged to consult the <a href="https://www.nhlbi.nih.gov/">NHLBI website</a>.</p><p>This NOFO will utilize a bi-phasic, milestone-driven mechanism of award. The objective of the application is to present the scientific rationale for the clinical trial and a comprehensive scientific and operational plan that describes it. The application should address project management, participant recruitment and retention, performance milestones, scientific conduct of the trial, and dissemination of results. The multiple PD/PI model is strongly encouraged but not required. Applicants are encouraged to include a PD/PI with expertise in biostatistics, clinical trial design, and coordination. The application should also describe its approaches to increase community engagement from conceptual design of the intervention through implementation and sustainability, close gaps in health outcomes within the US population, and increase health for all. </p>
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<a id='_bookmark261228' tabindex='-1' aria-hidden='true'></a>Funding Opportunity Goal(s)
</div>
<div class=" col-md-8 datacolumn">
<p>The Division of Cardiovascular Sciences supports research and training to foster heart and vascular research in the basic, translational, clinical and population sciences, and to foster training to build talented young investigators in these areas, funded through competitive research training grants.</p><p>The Division of Lung Diseases supports research and research training on the causes, diagnosis, prevention, and treatment of lung diseases and sleep disorders. </p><p>The Division of Blood Diseases and Resources supports and research and training to foster research and research training on the pathophysiology, diagnosis, treatment, and prevention of non-neoplastic blood diseases, including anemias, sickle cell disease, thalassemia; biology of red blood cells, white blood cells, and platelets, hematopoietic stem cells and the bone marrow niche, hemophilia and other abnormalities of hemostasis and thrombosis.</p><p>The Center for Translation Research and Implementation Science (CTRIS) plans, fosters, and supports late-stage research to identify promising approaches for ensuring successful integration of evidence and evidence-based interventions within clinical and public health settings, such as health centers, worksites, schools, and communities in the United States and abroad.</p><p>The National Center on Sleep Disorders Research (NCSDR) supports research and research training related to sleep disordered breathing, and the fundamental functions of sleep and circadian rhythms.</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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<a id='_bookmark261230' tabindex='-1' aria-hidden='true'></a>Posted Date
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March 18, 2026
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<a id='_bookmark261231' tabindex='-1' aria-hidden='true'></a>Open Date (Earliest Submission Date)
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May 02, 2026
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<th scope="col" colspan="3" style="border:2px solid #bcbcbc;" class="text-center">Application Due Dates</th>
<th scope="col" colspan="3" style="border:2px solid #bcbcbc;" class="text-center">Review and Award Cycles</th>
</tr>
<tr>
<th scope="col" style="width:16.66%;border-left:2px solid #bcbcbc;" class="text-center">New</th>
<th scope="col" style="width:16.66%" class="text-center">Renewal / Resubmission / Revision (as allowed)</th>
<th scope="col" style="width:16.66%;border-right:2px solid #bcbcbc;" class="text-center">AIDS - New/Renewal/Resubmission/Revision, as allowed</th>
<th scope="col" style="width:16.66%" class="text-center">Scientific Merit Review</th>
<th scope="col" style="width:16.66%" class="text-center">Advisory Council Review</th>
<th scope="col" style="width:16.66%;border-right:2px solid #bcbcbc;" class="text-center">Earliest Start Date</th>
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<tbody>
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<td>
June 02, 2026
</td>
<td>
July 02, 2026
</td>
<td>
Not Applicable
</td>
<td>November 2026</td>
<td> January 2027
</td>
<td>April 2027</td>
</tr>
<tr>
<td>
October 02, 2026
</td>
<td>
November 02, 2026
</td>
<td>
Not Applicable
</td>
<td>March 2027</td>
<td> May 2027
</td>
<td>July 2027</td>
</tr>
<tr>
<td>
February 01, 2027
</td>
<td>
March 01, 2027
</td>
<td>
Not Applicable
</td>
<td>July 2027</td>
<td> October 2027
</td>
<td>December 2027</td>
</tr>
<tr>
<td>
June 02, 2027
</td>
<td>
July 02, 2027
</td>
<td>
Not Applicable
</td>
<td>November 2027</td>
<td> January 2028
</td>
<td>April 2028</td>
</tr>
<tr>
<td>
October 01, 2027
</td>
<td>
November 01, 2027
</td>
<td>
Not Applicable
</td>
<td>March 2028</td>
<td> May 2028
</td>
<td>July 2028</td>
</tr>
<tr>
<td>
February 01, 2028
</td>
<td>
March 01, 2028
</td>
<td>
Not Applicable
</td>
<td>July 2028</td>
<td> October 2028
</td>
<td>December 2028</td>
</tr>
<tr>
<td>
June 01, 2028
</td>
<td>
June 30, 2028
</td>
<td>
Not Applicable
</td>
<td>November 2028</td>
<td> January 2029
</td>
<td>April 2029</td>
</tr>
<tr>
<td>
October 02, 2028
</td>
<td>
November 02, 2028
</td>
<td>
Not Applicable
</td>
<td>March 2029</td>
<td> May 2029
</td>
<td>July 2029</td>
</tr>
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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
</div>
<div class=" col-md-8 datacolumn">
<p>Not Applicable</p>
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<a id='_bookmark261242' tabindex='-1' aria-hidden='true'></a>Expiration Date
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November 03, 2028
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<a id='_bookmark261243' tabindex='-1' aria-hidden='true'></a>Required Application Instructions
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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>
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<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>
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<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>
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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>
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<a id='_bookmark261247' tabindex='-1' aria-hidden='true'></a><p><strong>NOFO</strong> <strong>Research Objectives</strong></p><p>This NOFO supports applications to develop and conduct investigator-initiated single-site clinical trials. Clinical trials supported by this NOFO include Phase II and above clinical trials. This NOFO is applicable to single-site clinical trials only, and will utilize a bi-phasic (R61/R33), milestone-driven mechanism consisting of a start-up phase of up to one year (R61), and a full enrollment and clinical trial execution phase of up to four years (R33). Proposed research may utilize a design anywhere along the continuum of efficacy, effectiveness, pragmatic and/or dissemination and implementation research clinical trials. For this NOFO, pragmatic trials are considered those that test an intervention under the usual clinical conditions in which it will be applied, while efficacy trials do so under more idealized circumstances. Implementation trials test strategies to adopt and integrate evidence-based health interventions and change practice patterns within specific settings. These implementation trials can include hybrid implementation/effectiveness studies. Innovative trial designs such as adaptive and Bayesian designs will be considered. The trial design should be appropriate for the study question. Trials for which this NOFO applies are expected to contribute to the evidence base for important health matters of relevance to the research mission of NHLBI, close gaps in health outcomes within the US population, and increase health for all. For additional information about the mission, strategic vision, and research priorities of the NHLBI, applicants are encouraged to consult the <a href="https://www.nhlbi.nih.gov/">NHLBI website</a>. </p><p>A key characteristic of this NOFO is completion of core milestones. A core milestone is defined as a scheduled event in the project timeline that signifies the completion of a major project stage or activity. Milestones must be performance-based to achieve completion of the trial on time and on budget, and must be established for both the R61 and R33 phases of the project. These clinical trials are expected to be conducted with a high degree of efficiency, with streamlined administrative procedures wherever possible. Applicants are strongly encouraged to employ project management principles as appropriate. Applications that address contingency plans to proactively confront potential delays or disturbances in meeting the milestones are strongly encouraged. </p><p>The definition of a single-site clinical trial is one in which the protocol is implemented by one investigational site that conducts and coordinates the protocol. While a single-site clinical trial may enroll participants from multiple locations/clinics within a geographic area, those participants will receive an intervention or undergo outcome assessments under the direction and oversight of one research team at one investigational site. </p><p><strong>Phases of Award</strong></p><p>The R61 phase will support finalization of the protocol and the informed consent/assent document; the development of the manual of operations and procedures, case report forms and other resources necessary to the performance of the trial; further development of study partnerships; establishment of a Data and Safety Monitoring Board (DSMB) and review and approval of the protocol by the DSMB; and Institutional Review Board approval of the trial. </p><p>For trials using an FDA regulated product and requiring an IND or IDE application to administer the product to humans, investigators must (1) secure IND authorization or IDE approval and (2) provide documentation of this authorization or approval to NHLBI before a funding decision will be made. Necessary drugs, devices, or other resources must be obtained by the end of the R61 award to allow for the successful launch and execution of the proposed clinical trial in the R33 phase. </p><p>Investigators and NHLBI will review and mutually agree upon final revised milestones that will be included in the Terms and Conditions of the grant, if awarded. Transition from the R61 to the R33 phase is predicated on the successful completion of all milestones proposed and peer-review for the R61 phase of the application. The core milestones must be met during the R61 phase to allow for successful launch of the full trial in the R33 phase. The overall planned enrollment will be agreed upon between the recipient and the NHLBI prior to an award. Enrollment of participants into the clinical trial is expected to begin before the end of the R61 phase to optimize the probability of successfully completing the trial on time and on budget. NHLBI will conduct an administrative review approximately 9 months into the R61 phase to determine progress toward achievement of milestones included in the Notice of Award. Milestones and timelines for the R33 phase may be revised and finalized at the time of the R61/R33 transition. Less than satisfactory progress in the R33 phase may lead to closing out the award. </p><p>R33 milestones must address timing of overall recruitment/enrollment and retention goals, including accrual goals for women, minorities, and individuals of all ages including children and older adults. It is expected that performance of core milestones, such as planned enrollment goals, will be shared on a regular basis through <a href="https://econnect.nhlbi.nih.gov/econnect/">eConnect</a>, an NHLBI platform that facilitates transfer of electronic information to NHLBI. Subject to NHLBI funding availability and scientific priorities, R33 awards will be made after administrative review with specific attention to the extent to which all agreed-upon R61 milestones have been met. If the R33 is funded, NHLBI will review the progress of the clinical trial on a regular basis. Slower than anticipated progress towards meeting milestones will result in a re-evaluation of the award by NHLBI including whether the objectives of the trial can be met on time and on budget. If milestones have not been satisfactorily met, subsequent funding years may not be approved and may lead to closing out the award. </p><p>NHLBI policies regarding milestones and relevant clinical research/studies policies are described in the following: <a href="https://www.nhlbi.nih.gov/research/funding/human-subjects/accrual-guidelines">NHLBI Accrual of Human Subjects (Milestones) Policy</a>, <a href="http://www.nhlbi.nih.gov/research/funding/human-subjects/women-minority-policy">NHLBI Policy for Inclusion of Women and Minorities in Clinical Research</a>, <a href="http://www.nhlbi.nih.gov/research/funding/human-subjects/data-safety-monitoring-policy">NHLBI Policy for Data and Safety Monitoring of Extramural Clinical Studies,</a> and <a href="https://www.nhlbi.nih.gov/grants-and-training/policies-and-guidelines/nhlbi-policy-for-data-sharing"><u>NHLBI Supplement to the NIH Policy for Data Management and Sharing</u></a>.</p><p><strong>Investigators</strong></p><p>This NOFO encourages investigators experienced in the conduct of clinical research to apply. Early Stage Investigators with clinical research experience are strongly encouraged to apply, provided they will receive scientific support from senior investigators (e.g., as Co-Investigators). </p><p><strong>Clinical Trials Not Supported by and Non-Responsive to this NOFO</strong></p><p>The following types of clinical trials are not intended to be supported by this NOFO and will be considered non-responsive:</p><ul><li>Phase I (first-in-human) trials</li><li>Observational studies that do not meet the NIH definition of a clinical trial (see <a href="https://grants.nih.gov/grants/guide/notice-files/NOT-HL-18-611.html">NOT-HL-18-611</a>)</li><li>Multi-site trials</li><li>Drug or device safety trials</li><li>Mechanistic or Basic Experimental Studies in Humans (BESH) (<a href="https://grants.nih.gov/grants/guide/notice-files/NOT-HL-19-690.html">NOT-HL-19-690</a>)</li></ul><p><strong>Prior to Submission</strong></p><p><strong>Prior to submitting</strong> to this NOFO, all applicants are <strong>strongly</strong> <strong>encouraged</strong> to consult with the Scientific/Research contacts for the area of science for which they are planning to develop an application. Early contact (at least 12 weeks prior to submission) is encouraged. This period of time provides an opportunity for NHLBI staff to discuss the scope and goals, and to provide information and guidance to the applicants. </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>
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<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>
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<a id='_bookmark261252' tabindex='-1' aria-hidden='true'></a>Funding Instrument
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<p>Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.</p>
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<a id='_bookmark261253' tabindex='-1' aria-hidden='true'></a> Application Types Allowed
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New
<br>
Resubmission
<br>
Revision
<br>
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<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>
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<a id='_bookmark261256' tabindex='-1' aria-hidden='true'></a>Clinical Trial?
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<p>Required: Only accepting applications that propose clinical trial(s).</p>
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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>
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<a id='_bookmark261258' tabindex='-1' aria-hidden='true'></a>Funds Available and Anticipated Number of Awards
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<p class="Normal" paraeid="{4cdb0268-1afb-4f09-9079-6ed8030b9692}{165}" paraid="1347832785">The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. </p>
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<a id='_bookmark261259' tabindex='-1' aria-hidden='true'></a>Award Budget
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<p class="Normal">Application budgets are not limited but need to reflect the actual needs of the proposed project. </p>
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<a id='_bookmark261260' tabindex='-1' aria-hidden='true'></a>Award Project Period
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<p>The scope of the proposed project should determine the requested project award period. </p><p>The maximum project period of the combined R61 and R33 phases is 5 years, with up to 1 year for the R61 phase and up to 4 years for the R33 phase. </p>
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<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>
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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>
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<a id='_bookmark261263' tabindex='-1' aria-hidden='true'></a><h4>1. Eligible Applicants</p>
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<a id='_bookmark261264' tabindex='-1' aria-hidden='true'></a>Eligible Organizations
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<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>
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<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>
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<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>
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<a id='_bookmark261268' tabindex='-1' aria-hidden='true'></a><h4>Foreign Organizations/International Collaborations</h4>
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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>
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<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>
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<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>
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<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>
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<a id='_bookmark261272' tabindex='-1' aria-hidden='true'></a>Required Registrations
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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>
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<a id='_bookmark261273' tabindex='-1' aria-hidden='true'></a>Eligible Individuals (Program Director/Principal Investigator)
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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 appl
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