Maximizing Investigators' Research Award (MIRA) (R35 - Clinical Trial Optional)
National Institutes of Health
Funding Amount
Varies
Deadline
May 26, 2028
778 days left
Grant Type
federal
Overview
Maximizing Investigators' Research Award (MIRA) (R35 - Clinical Trial Optional)
The Maximizing Investigators' Research Award (MIRA) provides support for individual investigators for research within the scientific mission of NIGMS via a single grant to achieve the following:Increase the stability of funding for NIGMS-supported investigators, which could enhance their ability to take on ambitious scientific projects and approach problems more creatively;Increase flexibility for investigators to follow important new research directions within the NIGMS mission as opportunities arise, rather than being bound to specific aims proposed in advance of the studies;More widely distribute funding among the nation's highly talented and promising investigators to increase overall scientific productivity and the chances for important breakthroughs;Reduce the time spent by researchers writing and reviewing grant applications, allowing them to spend more time conducting research;Reduce the administrative burden associated with a PD/PI managing multiple NIGMS research grants; andEnable PD(s)/PI(s) to devote more time and energy to mentoring junior scientists in a more stable research environment.This NOFO invites applications from eligible NIGMS-funded investigators and from New Investigators proposing research that is aligned with NIGMS' scientific mission. The NOFO also allows renewal applications from all current MIRA grantees (including those previously funded as Early-Stage Investigators). Current Early-Stage Investigators (ESIs) should apply through the ESI MIRA NOFO, not this NOFO.
Details
- Agency: National Institutes of Health
- Department: Department of Health and Human Services
- Opportunity #: PAR-26-121
- Instrument: grant
Eligibility
Refer to Section III. Eligibility Information in the NOFO for additional information on eligibility.Foreign Organizations/Foreign CollaborationsNon-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are not 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 re
Eligibility
Eligible Applicant Types
How to Apply
PAR-26-121-Full-Announcement.html
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<title>PAR-26-121: Maximizing Investigators' Research Award (MIRA) (R35 - 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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<div data-element-id="261373" data-element-has-label="false" data-element-required="false" data-element-has-value="true" data-section-code="OI" data-element-type="TEXT">
<a id='_bookmark261373' 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='_bookmark261374' 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='_bookmark261376' tabindex='-1' aria-hidden='true'></a>Components of Participating Organizations
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<p>National Institute of General Medical Sciences (<a href="https://www.nigms.nih.gov/" target="_blank" rel="noreferrer">NIGMS</a>)
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<a id='_bookmark261378' tabindex='-1' aria-hidden='true'></a>Funding Opportunity Title
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<span class="title">Maximizing Investigators' Research Award (MIRA) (R35 - Clinical Trial Optional)</span>
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<a id='_bookmark261379' 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=r35&Search.x=0&Search.y=0&sort=ac&Search_Type=Activity&text_prev=">R35</a> Outstanding Investigator Award</p>
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<a id='_bookmark261380' tabindex='-1' aria-hidden='true'></a>Announcement Type
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Reissue of
<a href="https://grants.nih.gov/grants/guide/pa-files/PAR-22-180.html" target="_blank" rel="noreferrer">PAR-22-180</a>
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<a id='_bookmark261381' 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='_bookmark261382' tabindex='-1' aria-hidden='true'></a>Funding Opportunity Number (FON)
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<span class="noticenum">PAR-26-121</span>
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<a id='_bookmark261383' tabindex='-1' aria-hidden='true'></a>Companion Funding Opportunity
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None
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<a id='_bookmark261384' tabindex='-1' aria-hidden='true'></a>Number of Applications
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<p>See <a href="#_3._Additional_Information">Section III. 3. Additional Information on Eligibility</a>.</p>
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<a id='_bookmark261385' tabindex='-1' aria-hidden='true'></a>Assistance Listing Number(s)
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93.859
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<a id='_bookmark261386' tabindex='-1' aria-hidden='true'></a>Funding Opportunity Purpose
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<p>The Maximizing Investigators' Research Award (MIRA) provides support for individual investigators for research within the <a href="https://www.nigms.nih.gov/about/overview/Pages/Overview">scientific mission of NIGMS</a> via a single grant to achieve the following:</p><ul><li>Increase the stability of funding for NIGMS-supported investigators, which could enhance their ability to take on ambitious scientific projects and approach problems more creatively;</li><li>Increase flexibility for investigators to follow important new research directions within the NIGMS mission as opportunities arise, rather than being bound to specific aims proposed in advance of the studies;</span></li><li>More widely distribute funding among the nation's highly talented and promising investigators to increase overall scientific productivity and the chances for important breakthroughs;</span></li><li>Reduce the time spent by researchers writing and reviewing grant applications, allowing them to spend more time conducting research;</li><li>Reduce the administrative burden associated with a PD/PI managing multiple NIGMS research grants; and</li><li>Enable PD(s)/PI(s) to devote more time and energy to mentoring junior scientists in a more stable research environment. </li></ul><p>This NOFO invites applications from eligible NIGMS-funded investigators and from <a href="https://grants.nih.gov/policy/early-stage/index.htm">New Investigators</a> proposing research that is aligned with NIGMS' scientific mission. The NOFO also allows <a href="https://grants.nih.gov/grants/glossary.htm#RenewalApplication">renewal applications</a> from all current MIRA grantees (including those previously funded as Early-Stage Investigators). Current <a href="https://grants.nih.gov/grants/glossary.htm#EarlyStageInvestigator(ESI)">Early-Stage Investigators (ESIs)</a> should apply through the <a href="https://www.nigms.nih.gov/research/mechanisms/mira/pages/default.aspx">ESI MIRA</a> NOFO, not this NOFO.</p>
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<a id='_bookmark261388' tabindex='-1' aria-hidden='true'></a>Funding Opportunity Goal(s)
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<p>The National Institute of General Medical Sciences (NIGMS) supports basic research that increases our understanding of biological processes and lays the foundation for advances in disease diagnosis, treatment, and prevention. NIGMS also supports research in specific clinical areas that affect multiple organ systems: anesthesiology and peri-operative pain; clinical pharmacology ​common to multiple drugs and treatments; and injury, critical illness, sepsis, and wound healing.​ NIGMS-funded scientists investigate how living systems work at a range of levels — from molecules and cells to tissues and organs — in research organisms, humans, and populations. Additionally, to ensure the vitality and continued productivity of the research enterprise, NIGMS provides leadership in supporting the training of future scientists and developing research capacity throughout the country.</p>
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<a id='_bookmark261389' tabindex='-1' aria-hidden='true'></a><a name="_Key Dates"></a><h2>Key Dates</h2>
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<a id='_bookmark261391' tabindex='-1' aria-hidden='true'></a>Open Date (Earliest Submission Date)
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December 27, 2025
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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>
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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>
<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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January 27, 2026
</td>
<td>
January 27, 2026
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<td>
Not Applicable
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<td>July 2026</td>
<td> October 2026
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<td>December 2026</td>
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May 27, 2026
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<td>
May 27, 2026
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<td>
Not Applicable
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<td>November 2026</td>
<td> January 2027
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<td>April 2027</td>
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<td>
January 27, 2027
</td>
<td>
January 27, 2027
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<td>
Not Applicable
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<td>July 2027</td>
<td> October 2027
</td>
<td>December 2027</td>
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<td>
May 27, 2027
</td>
<td>
May 27, 2027
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<td>
Not Applicable
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<td>November 2027</td>
<td> January 2028
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<td>April 2028</td>
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<td>
January 27, 2028
</td>
<td>
January 27, 2028
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Not Applicable
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<td>July 2028</td>
<td> October 2028
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<td>December 2028</td>
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May 26, 2028
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<td>
May 26, 2028
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<td>
Not Applicable
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<td>November 2028</td>
<td> January 2029
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<td>April 2029</td>
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<a id='_bookmark261395' 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='_bookmark261401' tabindex='-1' aria-hidden='true'></a>Expiration Date
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May 27, 2028
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<a id='_bookmark261402' tabindex='-1' aria-hidden='true'></a>Due Dates for E.O. 12372
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<p>Not Applicable</p>
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<a id='_bookmark262221' 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 <a href="https://grants.nih.gov/grants/guide/url_redirect.htm?id=82400">How to Apply - Application Guide</a> and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the <a href="https://grants.nih.gov/grants/guide/url_redirect.htm?id=82400">How to Apply - Application Guide</a> as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the <a href="https://grants.nih.gov/grants/guide/url_redirect.htm?id=82400">How to Apply - Application Guide</a>, 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='_bookmark261403' 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="#_Part1.OverviewInformation">Part 1. Overview Information</a></div><div class="toc-link P_SingleIndent"><a href="#_KeyDates">Key Dates</a></div><div class="toc-link"><a href="#_Part2.FullTextofAnnouncement">Part 2. Full Text of Announcement</a></div><div class="toc-link P_SingleIndent"><a href="#_SectionI.NoticeofFundingOpportunityDescription">Section I. Notice of Funding Opportunity Description</a></div><div class="toc-link P_SingleIndent"><a href="#_SectionII.AwardInformation">Section II. Award Information</a></div><div class="toc-link P_SingleIndent"><a href="#_SectionIII.EligibilityInformation">Section III. Eligibility Information</a></div><div class="toc-link P_SingleIndent"><a href="#_SectionIV.ApplicationandSubmissionInformation">Section IV. Application and Submission Information</a></div><div class="toc-link P_SingleIndent"><a href="#_SectionV.ApplicationReviewInformation">Section V. Application Review Information</a></div><div class="toc-link P_SingleIndent"><a href="#_SectionVI.AwardAdministrationInformation">Section VI. Award Administration Information</a></div><div class="toc-link P_SingleIndent"><a href="#_SectionVII.AgencyContacts">Section VII. Agency Contacts</a></div><div class="toc-link P_SingleIndent"><a href="#_SectionVIII.OtherInformation">Section VIII. Other Information</a></div>
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<a id='_bookmark261405' 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='_bookmark261406' 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='_bookmark261407' tabindex='-1' aria-hidden='true'></a><h4>Purpose</h4><p style="margin-left:0px;">To enhance grant funding efficiency and efficacy, the NIGMS established the <a href="https://www.nigms.nih.gov/research/mechanisms/MIRA/pages/default.aspx">Maximizing Investigators' Research Award (MIRA)</a>, a single grant that provides support for an investigator's NIGMS-aligned research program, encompassing all projects within their laboratory that align with the <a href="https://www.nigms.nih.gov/about/overview/pages/default.aspx">scientific mission of NIGMS</a>.</p><p style="margin-left:0px;">It is anticipated that MIRA will achieve the following:</p><ul><li>Increase the stability of funding for NIGMS-supported investigators, which could enhance their ability to take on ambitious scientific projects and approach problems more creatively;</li><li>Increase flexibility for investigators to follow important new research directions within the NIGMS mission as opportunities arise, rather than being bound to specific aims proposed in advance of the studies;</li><li>More widely distribute funding among the nation's highly talented and promising investigators to increase overall scientific productivity and the chances for important breakthroughs;</li><li>Reduce the time spent by researchers writing and reviewing grant applications, allowing them to spend more time conducting research;</li><li>Reduce the administrative burden associated with a PD/PI managing multiple NIGMS research grants; and</li><li>Enable PD(s)/PI(s) to devote more time and energy to mentoring junior scientists in a more stable research environment.</li></ul><p style="margin-left:0px;">This NOFO invites new applications from eligible investigators as defined in the eligibility section (<a href="https://public.era.nih.gov/foa/docTemplates/55896/exportDocument/html/foaRequest.era?tracking=true#_Section%20III.%20Eligibility%20Information">Section III. 1</a>) and renewals from all current MIRA recipients. Early-Stage Investigators (ESIs) should apply through the <a href="https://www.nigms.nih.gov/research/mechanisms/mira/pages/default.aspx">ESI MIRA</a> NOFO, not this NOFO.</p><p style="margin-left:0px;">The NIGMS MIRA differs from other institutes' R35 awards in that the MIRA is not a grant designed to only support a small number of investigators; instead, as described in the Institute's 2021-2025 <a href="https://www.nigms.nih.gov/about-nigms/what-we-do/strategic-plans">strategic plan</a>, MIRAs represent over 60% of NIGMS' R01-equivalent awards.</p><p style="margin-left:0px;">NIGMS will ensure a broad research portfolio, encompassing varied scientific disciplines, methodologies, geographic regions, institutions, and investigators. This approach maximizes the exploration of innovative ideas and enhances the potential for high impact scientific breakthroughs.</p><h4>Overview of the MIRA</h4><p>The NIGMS MIRA is intended to provide support for the <a href="https://www.nigms.nih.gov/about/overview/pages/default.aspx">NIGMS-mission aligned</a> research program in an investigator’s laboratory. NIGMS supports basic research on biological processes as well as translational and clinical research in <a href="https://www.nigms.nih.gov/Research/specificareas/Pages/ClinicalResearchAreas">specific areas</a>. In addition to investigating scientific questions, MIRA can support technology development and computational approaches, either as sole research program interests or as components of a broader research program. MIRA investigators have the flexibility to explore new ideas, techniques, and approaches, provided the research remains within the scientific mission of NIGMS. Research involving human subjects, vertebrate animals, stem cells, select agents, or foreign components requires prior approval by NIGMS staff per existing policies and procedures.</p><p>Compared to traditional R01 funding, the MIRA offers distinct advantages:</p><ul><li>Grants typically have longer grant periods, on average, than NIGMS R01s;</li><li>Allows flexibility in changing research directions;</li><li>Significantly higher renewal rates as compared to NIGMS R01s;</li><li>Reduced administrative burden by consolidating multiple current or prospective NIGMS research grants into a single award, allowing investigators to spend less time on application writing and grant management, and more time on research.</li></ul><p>Although mutually beneficial collaborations are encouraged during the course of a MIRA, the MIRA is designed to support the NIGMS-aligned research of an independent investigator's laboratory. For research requiring financial support of collaborators and subcontractors, other funding mechanisms may be more appropriate.</p><p>Research involving human subjects is permitted in the MIRA program. Clinical research must be completely within the context of the research areas supported by NIGMS, which include several specific <a href="https://www.nigms.nih.gov/Research/specificareas/Pages/ClinicalResearchAreas.aspx">clinical areas</a>: anesthesiology, perioperative pain, clinical pharmacology, sepsis, injury and critical illness, wound healing, innate immunity and inflammation. Clinical research that involves recruitment of human subjects at more than one site or the substantial financial support of multiple collaborators and subcontractors is not allowed, because these fixed commitments are not consistent with the highly flexible nature of the MIRA program. <a href="https://grants.nih.gov/grants/glossary.htm#MechanisticStudy">Mechanistic</a> <a href="https://grants.nih.gov/grants/glossary.htm#ClinicalTrial">clinical trials</a> are permitted in MIRA when the mechanistic study is an essential part of the research program. Clinical trials that are designed to test safety and efficacy of interventions (Phase I, Phase II, Phase III) for the purpose of future clinical treatment and/or regulatory approval are not permitted in MIRA. Studies that propose clinical dissemination and implementation research, comparative effectiveness research, and/or pragmatic clinical trials are also not permitted.</p><p>Potential applicants are strongly encouraged to confer with the NIGMS <a href="https://www.nigms.nih.gov/about/pages/contactbyarea.aspx">program official</a> managing their qualifying award(s) or relevant research portfolio(s), or for additional questions, the Scientific/Research Contacts listed in this NOFO (in <a href="https://public.era.nih.gov/foa/docTemplates/55896/exportDocument/html/foaRequest.era?tracking=true#_Section%20VII.%20Agency%20Contacts">Section VII. Agency Contacts</a>) before submitting a MIRA application. NIGMS will not fund applications containing research projects that align with the missions of other NIH Institutes and Centers or federal agencies.</p><p><strong>Overlap During Peer Review</strong></p><p>Since a MIRA is designed to provide support for a PD's/PI's entire NIGMS-mission-aligned research program, it will overlap with most other NIGMS research grant applications. Therefore, a PD/PI may not have a MIRA application and another NIGMS research project grant application (e.g., R01, R15, R21, and R37) pending review at the same time. An application is pending review until its summary statement is issued. The following NIGMS applications are exempted from this policy:</p><ul><li>Grants supporting resources for the research community (e.g., R24 grants)</li><li>Collaborative Program Grant for Multidisciplinary Teams (RM1) grants;</li><li>Biomedical Technology Optimization and Dissemination (RM1) grants; Training or workforce development;</li><li>Multi-site <a href="https://www.nigms.nih.gov/Research/clinicaltrials/pages/investigatorapps.aspx">clinical research</a>, both clinical trials and observational studies, with costs for patient recruitment, protocol-related expenses, and/or community resource activities (e.g., specimen banking, dissemination);</li><li>INBRE, COBRE, IDeA-CTRs, SEPA, and NARCH;</li><li>SBIR/STTR ;</li><li>Conference.</li></ul><p><strong>Resolving Overlap with Other NIGMS Research Grants During the Award Process</strong></p><p>A PD/PI awarded a MIRA must discontinue funding from other NIGMS research grants, except in specific situations as noted below. The following scenarios provide examples of how funding overlaps are addressed:</p><ul><li>A PD/PI receiving support as a collaborator or subcontractor on another investigator's NIGMS research project grant (e.g., R01, R15, R21, and R37) must discontinue such funding.</li><li>A PD/PI serving as a Project Leader or multiple PD/PI on a NIGMS multi-component grant or a Collaborative Program Grant for Multidisciplinary Teams (RM1), will have their MIRA award level adjusted to eliminate overlap. The PD/PI must discontinue funding from the multi-component grant at the end of its competitive segment. The PD/PI may continue to serve as a Project Leader or multi-PD/PI while maintaining at least 45% effort on the MIRA, but may not receive additional funds from the multi-component grant. NIGMS encourages collaborative and interdisciplinary research, and MIRA PDs/PIs may use MIRA funds to support their contributions for team-based research with other investigators. </li><li>A PD/PI serving as a PD/PI or subsection lead on a Biomedical Technology Optimization and Dissemination (BTOD) (RM1) grant may retain BTOD funding but must use it exclusively for late-stage technology optimization and dissemination efforts in their laboratory. MIRA funds may be used to support early-stage technology development efforts. The PD/PI must maintain at least 45% effort on their MIRA and commit at least 3 person-months to the BTOD grant if serving as a PD/PI, or at least 1 person-month if serving as a lead investigator for technology optimization projects (TOPs) or community engagement (CE). </li><li>A PD/PI with a NIGMS K award must discontinue the K award prior to the MIRA start date. A PD/PI with a K award from another NIH institute and Center may receive a MIRA but must reduce effort on the K award to be less than the effort committed to the MIRA (measured in person-months). </li></ul><p>NIGMS will facilitate an orderly process to transition to MIRA funding when reductions in other commitments are required. Specific details will be provided by NIGMS staff on a case by case basis.</p><p>The MIRA budget will be determined by NIGMS staff, based upon the PD's/PI's prior NIGMS funding history, recommendations from the peer review group and the National Advisory General Medical Sciences Council, and the expected productivity and impact of the proposed research program. MIRA applications from PDs/PIs whose total research support from all sources exceeds $1,500,000 in annual total costs are subjected to NIGMS' <a href="https://www.nigms.nih.gov/Research/Pages/unrestricted-support">Special Council Review</a> policy.</p><p>A PD/PI with more than $400,000 in direct costs from NIGMS research grants will generally receive a MIRA budget that is approximately 12% lower than the PD's/PI's average NIGMS research funding levels over recent years (as determined by NIGMS staff). MIRA budgets for New Investigators will generally be $275,000 in annual direct costs.</p><p>Budgets for MIRA renewals are determined independently based on a variety of considerations, including peer review outcomes, the PD's/PI’s other support and commitments, NIGMS' scientific priorities, and available budget. Overall, most MIRA renewal budgets are expected to be comparable to prior funding periods, though some may increase or decrease. For more information, see this <a href="https://loop.nigms.nih.gov/tag/mira/">Feedback Loop Post</a>.</p><p><strong>Applying for Subsequent Awards after Receiving a MIRA</strong></p><p>NIGMS will not accept assignment of an <a href="https://commonfund.nih.gov/tra">NIH Director's Transformative Research Award (TRA)</a> R01 or <a href="https://commonfund.nih.gov/pioneer">NIH Director's Pioneer Award (DP1)</a> application if the PD/PI has a MIRA, since by virtue of assignment to NIGMS, the proposed research falls within the mission of NIGMS and would by definition overlap with the MIRA.</p><p><strong>Supplements to MIRAs:</strong> </p><p>MIRA grants are eligible for <a href="https://www.nigms.nih.gov/Research/supplements/Pages/default">administrative supplements</a> offered by NIGMS, depending on the specific supplement program's intent and constraints.</p><p><strong>Renewals:</strong> </p><p>MIRA renewals are expected to have higher success rates compared to R01s due to the Institute's commitment to the program as well as the consolidation of separate research projects, which will result in fewer applications. If a MIRA renewal application is unsuccessful, the grant will terminate at the end of its approved project period. A <a href="https://grants.nih.gov/grants/glossary.htm#Resubmission">resubmission</a> (A1) application is not allowed; however, a PD/PI may submit a new MIRA application as long as they are eligible. </p><p>Any MIRA application submitted after a prior renewal's pending review must be a new application. However, if a renewal application is withdrawn prior to peer review, another renewal can be submitted in its place.</p>
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<a id='_bookmark261409' 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='_bookmark261410' tabindex='-1' aria-hidden='true'></a><p>See <a href="#_Section_VIII._Other">Section VIII. Other Information</a> for award authorities and regulations.</p>
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<a id='_bookmark261411' 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='_bookmark261412' 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='_bookmark261413' tabindex='-1' aria-hidden='true'></a> Application Types Allowed
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New
<br>
Renewal
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Revision
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<a id='_bookmark261415' 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 <a href="https://grants.nih.gov/grants/guide/url_redirect.htm?id=82400">How to Apply - Application Guide</a> provide details on these application types. Only those application types listed here are allowed for this NOFO.</p>
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<a id='_bookmark261416' tabindex='-1' aria-hidden='true'></a>Clinical Trial?
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<p>Optional: Accepting applications that either propose or do not propose clinical trial(s).</p>
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<a id='_bookmark261417' 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='_bookmark261418' tabindex='-1' aria-hidden='true'></a>Funds Available and Anticipated Number of Awards
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<p>The number of awards is contingent upon NIGMS appropriations and the submission of a sufficient number of meritorious applications.</p>
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<a id='_bookmark261419' tabindex='-1' aria-hidden='true'></a>Award Budget
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<p>Applications from investigators with existing NIGMS research grants may request up to $750,000 direct costs per year. Investigators should request well-justified costs that are aligned with their proposed research program, noting that efficient use of funds is an expectation of the MIRA program. Budget justification is considered during the review process and in making funding decisions. Generally, awards will be commensurate with the PD's/PI’s average total NIGMS research funding over the past few years.</p><p>For new applications from PDs/PIs previously funded through NIGMS R01-equivalents other than MIRAs, well-justified budget increases may be considered for PDs/PIs previously supported by budgets below $275,000 in annual direct costs, while modest reductions of approximately 12% on average, are expected for PDs/PIs with $400,000 or more in annual direct costs from NIGMS. The MIRA budget will typically be lower than an NIH <a href="https://commonfund.nih.gov/tra">Transformative Research Award</a> and will be significantly reduced from an <a href="https://commonfund.nih.gov/pioneer">NIH Director's Pioneer Award</a> (DP1).</p><p>MIRA budgets for New Investigators are typically set at $275,000 in annual direct costs, not including equipment.</p><p>For MIRA renewal applications, NIGMS expects that the award level may vary based on the justification and available funds. Meritorious renewal applications that are not prioritized for full funding may receive reduced budgets.</p><p>Equipment should be requested in Year 1 only. Unless equipment costs are requested, annual direct costs will remain constant throughout the award period.</p>
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<a id='_bookmark261420' tabindex='-1' aria-hidden='true'></a>Award Project Period
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<p class="Normal">Applications may request a maximum project period of five years.</p>
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<a id='_bookmark261421' 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='_bookmark261423' tabindex='-1' aria-hidden='true'></a><h4>1. Eligible Applicants</p>
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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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<li>Eligible Agencies of the Federal Government</li>
<li>U.S. Territory or Possession</li>
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<a id='_bookmark261426' 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>
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<a id='_bookmark261428' tabindex='-1' aria-hidden='true'></a><h4>Foreign Organizations/Foreign Collaborations</h4>
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<a id='_bookmark261429' tabindex='-1' aria-hidden='true'></a><p class="Normal">Non-domestic (non-U.S.) Entities (Foreign Organizations) <strong>are not</strong> eligible to apply.</p>
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<a id='_bookmark261430' tabindex='-1' aria-hidden='true'></a><p>Non-domestic (non-U.S.) components of U.S. Organizations <strong>are not</strong> eligible to apply.</p>
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<a id='_bookmark261431' tabindex='-1' aria-hidden='true'></a><p>Foreign components, as <a href="http://grants.nih.gov/grants/guide/url_redirect.htm?id=11118">defined in the <em>NIH Grants Policy Statement</em></a>, <strong>are </strong>allowed. </p>
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<title>PAR-26-121: Maximizing Investigators' Research Award (MIRA) (R35 - Clinical Trial Optional)</title>
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<div id="page-title" class="heading1" tabindex="0">Department of Health and Human Services</div>
<div>
<div data-element-id="261373" data-element-has-label="false" data-element-required="false" data-element-has-value="true" data-section-code="OI" data-element-type="TEXT">
<a id='_bookmark261373' tabindex='-1' aria-hidden='true'></a><a name="_Part 1. Overview Information"></a><h1>Part 1. Overview Information</h1>
</div>
<div class="row" data-index="2">
<div class="col-md-4 datalabel" tabindex="0" data-element-id="261374" data-element-required="true" data-element-has-value="true" data-section-code="OI" data-element-type="TEXT">
<a id='_bookmark261374' tabindex='-1' aria-hidden='true'></a>Participating Organization(s)
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<div class=" col-md-8 datacolumn">
<p>National Institutes of Health (<a href="http://www.nih.gov">NIH</a>)</p>
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<div class="row" data-index="3">
<div class="col-md-push-4 col-md-8 datacolumn">
</div>
</div>
<div class="row" data-index="4">
<div class="col-md-4 datalabel" tabindex="0" data-element-id="261376" data-element-required="true" data-element-has-value="true" data-section-code="OI" data-element-type="LINKED_ELEMENT">
<a id='_bookmark261376' tabindex='-1' aria-hidden='true'></a>Components of Participating Organizations
</div>
<div class=" col-md-8 datacolumn">
<p>National Institute of General Medical Sciences (<a href="https://www.nigms.nih.gov/" target="_blank" rel="noreferrer">NIGMS</a>)
</div>
</div>
<div class="row" data-index="5">
<div class="col-md-push-4 col-md-8 datacolumn">
</div>
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<div class="col-md-4 datalabel" tabindex="0" data-element-id="261378" data-element-required="true" data-element-has-value="true" data-section-code="OI" data-element-type="LINKED_ELEMENT">
<a id='_bookmark261378' tabindex='-1' aria-hidden='true'></a>Funding Opportunity Title
</div>
<div class=" col-md-8 datacolumn">
<span class="title">Maximizing Investigators' Research Award (MIRA) (R35 - Clinical Trial Optional)</span>
</div>
</div>
<div class="row" data-index="7">
<div class="col-md-4 datalabel" tabindex="0" data-element-id="261379" data-element-required="true" data-element-has-value="true" data-section-code="OI" data-element-type="TEXT">
<a id='_bookmark261379' 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=r35&Search.x=0&Search.y=0&sort=ac&Search_Type=Activity&text_prev=">R35</a> Outstanding Investigator Award</p>
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</div>
<div class="row" data-index="8">
<div class="col-md-4 datalabel" tabindex="0" data-element-id="261380" data-element-required="true" data-element-has-value="true" data-section-code="OI" data-element-type="LINKED_ELEMENT">
<a id='_bookmark261380' tabindex='-1' aria-hidden='true'></a>Announcement Type
</div>
<div class=" col-md-8 datacolumn">
Reissue of
<a href="https://grants.nih.gov/grants/guide/pa-files/PAR-22-180.html" target="_blank" rel="noreferrer">PAR-22-180</a>
<br/>
</div>
</div>
<div class="row" data-index="9">
<div class="col-md-4 datalabel" tabindex="0" data-element-id="261381" data-element-required="true" data-element-has-value="true" data-section-code="OI" data-element-type="TEXT">
<a id='_bookmark261381' 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>
</div>
<div class="row" data-index="10">
<div class="col-md-4 datalabel" tabindex="0" data-element-id="261382" data-element-required="true" data-element-has-value="true" data-section-code="OI" data-element-type="LINKED_ELEMENT">
<a id='_bookmark261382' tabindex='-1' aria-hidden='true'></a>Funding Opportunity Number (FON)
</div>
<div class=" col-md-8 datacolumn">
<span class="noticenum">PAR-26-121</span>
</div>
</div>
<div class="row" data-index="11">
<div class="col-md-4 datalabel" tabindex="0" data-element-id="261383" data-element-required="true" data-element-has-value="true" data-section-code="OI" data-element-type="LINKED_ELEMENT">
<a id='_bookmark261383' tabindex='-1' aria-hidden='true'></a>Companion Funding Opportunity
</div>
<div class=" col-md-8 datacolumn">
None
</div>
</div>
<div class="row" data-index="12">
<div class="col-md-4 datalabel" tabindex="0" data-element-id="261384" data-element-required="true" data-element-has-value="true" data-section-code="OI" data-element-type="TEXT">
<a id='_bookmark261384' tabindex='-1' aria-hidden='true'></a>Number of Applications
</div>
<div class=" col-md-8 datacolumn">
<p>See <suggestion-start name="formatInline:hqnoervnq67p:eda100731bde3c591f0ca80d89b70cc04:SOLISA_188"></suggestion-start><a href="#_3._Additional_Information">Section III. 3. Additional Information on Eligibility</a><suggestion-end name="formatInline:hqnoervnq67p:eda100731bde3c591f0ca80d89b70cc04:SOLISA_188"></suggestion-end>.</p>
</div>
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<div class="row" data-index="13">
<div class="col-md-4 datalabel" tabindex="0" data-element-id="261385" data-element-required="true" data-element-has-value="true" data-section-code="OI" data-element-type="LINKED_ELEMENT">
<a id='_bookmark261385' tabindex='-1' aria-hidden='true'></a>Assistance Listing Number(s)
</div>
<div class=" col-md-8 datacolumn">
93.859
</div>
</div>
<div class="row" data-index="14">
<div class="col-md-4 datalabel" tabindex="0" data-element-id="261386" data-element-required="true" data-element-has-value="true" data-section-code="OI" data-element-type="TEXT">
<a id='_bookmark261386' tabindex='-1' aria-hidden='true'></a>Funding Opportunity Purpose
</div>
<div class=" col-md-8 datacolumn">
<p>The Maximizing Investigators' Research Award (MIRA) provides support to individual investigators for research within the <a href="https://www.nigms.nih.gov/about/overview/Pages/Overview">scientific mission of NIGMS</a> via a single grant to achieve the following:</p><ul><li>Increase the stability of funding for NIGMS-supported investigators, which could enhance their ability to take on ambitious scientific projects and approach problems more creatively;</li><li>Increase flexibility for investigators to follow important new research directions within the NIGMS mission as opportunities arise, rather than being bound to specific aims proposed in advance of the studies;</span></li><li>More widely distribute funding among the nation's highly talented and promising investigators to increase overall scientific productivity and the chances for important breakthroughs;</span></li><li>Reduce the time spent by researchers writing and reviewing grant applications, allowing them to spend more time conducting research;</li><li>Reduce the administrative burden associated with a PD/PI managing multiple NIGMS research grants; and</li><li>Enable PDs/PIs to devote more time and energy to mentoring junior scientists in a more stable research environment. </li></ul><p>This NOFO invites applications from eligible NIGMS-funded investigators and from <a href="https://grants.nih.gov/policy/early-stage/index.htm">New Investigators</a> proposing research that is aligned with NIGMS' scientific mission. The NOFO also allows <a href="https://grants.nih.gov/grants/glossary.htm#RenewalApplication">renewal applications</a> from all current MIRA grantees (including those previously funded as Early-Stage Investigators). Current <a href="https://grants.nih.gov/grants/glossary.htm#EarlyStageInvestigator(ESI)">Early-Stage Investigators (ESIs)</a> should apply through the <a href="https://www.nigms.nih.gov/research/mechanisms/mira/pages/default.aspx">ESI MIRA</a> NOFO, not this NOFO.</p>
</div>
</div>
<div class="row" data-index="16">
<div class="col-md-4 datalabel" tabindex="0" data-element-id="261388" data-element-required="true" data-element-has-value="true" data-section-code="OI" data-element-type="TEXT">
<a id='_bookmark261388' tabindex='-1' aria-hidden='true'></a>Funding Opportunity Goal(s)
</div>
<div class=" col-md-8 datacolumn">
<p>The National Institute of General Medical Sciences (NIGMS) supports basic research that increases our understanding of biological processes and lays the foundation for advances in disease diagnosis, treatment, and prevention. NIGMS also supports research in specific clinical areas that affect multiple organ systems: anesthesiology and peri-operative pain; clinical pharmacology ​common to multiple drugs and treatments; and injury, critical illness, sepsis, and wound healing.​ NIGMS-funded scientists investigate how living systems work at a range of levels — from molecules and cells to tissues and organs — in research organisms, humans, and populations. Additionally, to ensure the vitality and continued productivity of the research enterprise, NIGMS provides leadership in supporting the training of future scientists and developing research capacity throughout the country.</p>
</div>
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<a id='_bookmark261389' tabindex='-1' aria-hidden='true'></a><a name="_Key Dates"></a><h2>Key Dates</h2>
</div>
<div class="row" data-index="18">
<div class="col-md-4 datalabel" tabindex="0" data-element-id="261390" data-element-required="true" data-element-has-value="false" data-section-code="KD" data-element-type="DATE">
<a id='_bookmark261390' tabindex='-1' aria-hidden='true'></a>Posted Date
</div>
<div class=" col-md-8 datacolumn">
</div>
</div>
<div class="row" data-index="19">
<div class="col-md-4 datalabel" tabindex="0" data-element-id="261391" data-element-required="true" data-element-has-value="true" data-section-code="KD" data-element-type="LINKED_ELEMENT">
<a id='_bookmark261391' tabindex='-1' aria-hidden='true'></a>Open Date (Earliest Submission Date)
</div>
<div class=" col-md-8 datacolumn">
December 27, 2025
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</div>
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<div data-element-id="261393" data-element-has-label="false" data-element-required="false" data-element-has-value="true" data-section-code="KD" data-element-type="LINKED_ELEMENT">
<a id='_bookmark261393' tabindex='-1' aria-hidden='true'></a>
<table class="table table-bordered table-striped table-hover eraDataTable" id="keyDatesContentTable">
<thead>
<tr>
<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>
</tr>
</thead>
<tbody>
<tr>
<td>
January 27, 2026
</td>
<td>
January 27, 2026
</td>
<td>
Not Applicable
</td>
<td>July 2026</td>
<td> October 2026
</td>
<td>December 2026</td>
</tr>
<tr>
<td>
May 27, 2026
</td>
<td>
May 27, 2026
</td>
<td>
Not Applicable
</td>
<td>November 2026</td>
<td> January 2027
</td>
<td>April 2027</td>
</tr>
<tr>
<td>
January 27, 2027
</td>
<td>
January 27, 2027
</td>
<td>
Not Applicable
</td>
<td>July 2027</td>
<td> October 2027
</td>
<td>December 2027</td>
</tr>
<tr>
<td>
May 27, 2027
</td>
<td>
May 27, 2027
</td>
<td>
Not Applicable
</td>
<td>November 2027</td>
<td> January 2028
</td>
<td>April 2028</td>
</tr>
<tr>
<td>
January 27, 2028
</td>
<td>
January 27, 2028
</td>
<td>
Not Applicable
</td>
<td>July 2028</td>
<td> October 2028
</td>
<td>December 2028</td>
</tr>
<tr>
<td>
May 26, 2028
</td>
<td>
May 26, 2028
</td>
<td>
Not Applicable
</td>
<td>November 2028</td>
<td> January 2029
</td>
<td>April 2029</td>
</tr>
</tbody>
</table>
</div>
<div data-element-id="261394" data-element-has-label="false" data-element-required="false" data-element-has-value="false" data-section-code="KD" data-element-type="TEXT">
</div>
<div data-element-id="261395" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="KD" data-element-type="TEXT">
<a id='_bookmark261395' 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>
</div>
<div data-element-id="261396" data-element-has-label="false" data-element-required="false" data-element-has-value="false" data-section-code="KD" data-element-type="CHECKBOX">
</div>
<div data-element-id="261397" data-element-has-label="false" data-element-required="false" data-element-has-value="false" data-section-code="KD" data-element-type="TEXT">
</div>
<div data-element-id="261398" data-element-has-label="false" data-element-required="false" data-element-has-value="false" data-section-code="KD" data-element-type="TEXT">
</div>
<div data-element-id="261399" data-element-has-label="false" data-element-required="false" data-element-has-value="false" data-section-code="KD" data-element-type="TEXT">
</div>
<div data-element-id="261400" data-element-has-label="false" data-element-required="false" data-element-has-value="false" data-section-code="KD" data-element-type="TEXT">
</div>
<div class="row" data-index="28">
<div class="col-md-4 datalabel" tabindex="0" data-element-id="261401" data-element-required="true" data-element-has-value="true" data-section-code="KD" data-element-type="LINKED_ELEMENT">
<a id='_bookmark261401' tabindex='-1' aria-hidden='true'></a>Expiration Date
</div>
<div class=" col-md-8 datacolumn">
May 27, 2028
</div>
</div>
<div class="row" data-index="29">
<div class="col-md-4 datalabel" tabindex="0" data-element-id="261402" data-element-required="true" data-element-has-value="true" data-section-code="KD" data-element-type="TEXT">
<a id='_bookmark261402' tabindex='-1' aria-hidden='true'></a>Due Dates for E.O. 12372
</div>
<div class=" col-md-8 datacolumn">
<p>Not Applicable</p>
</div>
</div>
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<div class="heading4" tabindex="0" data-element-id="262221" data-element-required="true" data-element-has-value="true" data-section-code="KD" data-element-type="TEXT">
<a id='_bookmark262221' tabindex='-1' aria-hidden='true'></a>Required Application Instructions
</div>
<div data-element-id="262221" data-element-has-label="true" data-element-required="true" data-element-has-value="true" data-section-code="KD" data-element-type="TEXT">
<p>It is critical that applicants follow the instructions in the Research (R) Instructions in the <a href="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 <a href="https://grants.nih.gov/grants/guide/url_redirect.htm?id=82400">How to Apply - Application Guide</a> and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the <a href="https://grants.nih.gov/grants/guide/url_redirect.htm?id=82400">How to Apply - Application Guide</a> as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the <a href="https://grants.nih.gov/grants/guide/url_redirect.htm?id=82400">How to Apply - Application Guide</a>, follow the program-specific instructions.</p><p><strong>Applications that do not comply with these instructions may be delayed or not accepted for review.</strong></p>
</div>
<div data-element-id="261403" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="KD" data-element-type="TEXT">
<a id='_bookmark261403' 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="#_Part1.OverviewInformation">Part 1. Overview Information</a></div><div class="toc-link P_SingleIndent"><a href="#_KeyDates">Key Dates</a></div><div class="toc-link"><a href="#_Part2.FullTextofAnnouncement">Part 2. Full Text of Announcement</a></div><div class="toc-link P_SingleIndent"><a href="#_SectionI.NoticeofFundingOpportunityDescription">Section I. Notice of Funding Opportunity Description</a></div><div class="toc-link P_SingleIndent"><a href="#_SectionII.AwardInformation">Section II. Award Information</a></div><div class="toc-link P_SingleIndent"><a href="#_SectionIII.EligibilityInformation">Section III. Eligibility Information</a></div><div class="toc-link P_SingleIndent"><a href="#_SectionIV.ApplicationandSubmissionInformation">Section IV. Application and Submission Information</a></div><div class="toc-link P_SingleIndent"><a href="#_SectionV.ApplicationReviewInformation">Section V. Application Review Information</a></div><div class="toc-link P_SingleIndent"><a href="#_SectionVI.AwardAdministrationInformation">Section VI. Award Administration Information</a></div><div class="toc-link P_SingleIndent"><a href="#_SectionVII.AgencyContacts">Section VII. Agency Contacts</a></div><div class="toc-link P_SingleIndent"><a href="#_SectionVIII.OtherInformation">Section VIII. Other Information</a></div>
</div><br/>
<div data-element-id="261405" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="FOD" data-element-type="TEXT">
<a id='_bookmark261405' tabindex='-1' aria-hidden='true'></a><a name="_Part 2. Full Text of Announcement"></a><h1>Part 2. Full Text of Announcement</h1>
</div>
<div data-element-id="261406" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="FOD" data-element-type="TEXT">
<a id='_bookmark261406' 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>
<div data-element-id="261407" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="FOD" data-element-type="TEXT">
<a id='_bookmark261407' tabindex='-1' aria-hidden='true'></a><h4>Purpose</h4><p style="margin-left:0px;">To enhance grant funding efficiency and efficacy, the NIGMS established the <a href="https://www.nigms.nih.gov/research/mechanisms/MIRA/pages/default.aspx">Maximizing Investigators' Research Award (MIRA)</a>, a single grant that provides support for an investigator's NIGMS-aligned research program, encompassing all projects within their laboratory that align with the <a href="https://www.nigms.nih.gov/about/overview/pages/default.aspx">scientific mission of NIGMS</a>.</p><p style="margin-left:0px;">It is anticipated that MIRA will achieve the following:</p><ul><li>Increase the stability of funding for NIGMS-supported investigators, which could enhance their ability to take on ambitious scientific projects and approach problems more creatively;</li><li>Increase flexibility for investigators to follow important new research directions within the NIGMS mission as opportunities arise, rather than being bound to specific aims proposed in advance of the studies;</li><li>More widely distribute funding among the nation's highly talented and promising investigators to increase overall scientific productivity and the chances for important breakthroughs;</li><li>Reduce the time spent by researchers writing and reviewing grant applications, allowing them to spend more time conducting research;</li><li>Reduce the administrative burden associated with a PD/PI managing multiple NIGMS research grants; and</li><li>Enable PD(s)/PI(s) to devote more time and energy to mentoring junior scientists in a more stable research environment.</li></ul><p style="margin-left:0px;">This NOFO invites new applications from eligible investigators as defined in the eligibility section (<a href="https://public.era.nih.gov/foa/docTemplates/55896/exportDocument/html/foaRequest.era?tracking=true#_Section%20III.%20Eligibility%20Information">Section III. 1</a>) and renewals from all current MIRA recipients. Early-Stage Investigators (ESIs) should apply through the <a href="https://www.nigms.nih.gov/research/mechanisms/mira/pages/default.aspx">ESI MIRA</a> NOFO, not this NOFO.</p><p style="margin-left:0px;">The NIGMS MIRA differs from other institutes' R35 awards in that the MIRA is not a grant designed to only support a small number of investigators; instead, as described in the Institute's 2021-2025 <a href="https://www.nigms.nih.gov/about-nigms/what-we-do/strategic-plans">strategic plan</a>, MIRAs represent over 60% of NIGMS' R01-equivalent awards.</p><p style="margin-left:0px;">NIGMS will ensure a broad research portfolio, encompassing varied scientific disciplines, methodologies, geographic regions, institutions, and investigators. This approach maximizes the exploration of innovative ideas and enhances the potential for high impact scientific breakthroughs.</p><h4>Overview of the MIRA</h4><p>The NIGMS MIRA is intended to provide support for the <a href="https://www.nigms.nih.gov/about/overview/pages/default.aspx">NIGMS-mission aligned</a> research program in an investigator’s laboratory. NIGMS supports basic research on biological processes as well as translational and clinical research in <a href="https://www.nigms.nih.gov/Research/specificareas/Pages/ClinicalResearchAreas">specific areas</a>. In addition to investigating scientific questions, MIRA can support technology development and computational approaches, either as sole research program interests or as components of a broader research program. MIRA investigators have the flexibility to explore new ideas, techniques, and approaches, provided the research remains within the scientific mission of NIGMS. Research involving human subjects, vertebrate animals, stem cells, select agents, or foreign components requires prior approval by NIGMS staff per existing policies and procedures.</p><p>Compared to traditional R01 funding, the MIRA offers distinct advantages:</p><ul><li>Grants typically have longer grant periods, on average, than NIGMS R01s;</li><li>Allows flexibility in changing research directions;</li><li>Significantly higher renewal rates as compared to NIGMS R01s;</li><li>Reduced administrative burden by consolidating multiple current or prospective NIGMS research grants into a single award, allowing investigators to spend less time on application writing and grant management, and more time on research.</li></ul><p>Although mutually beneficial collaborations are encouraged during the course of a MIRA, the MIRA is designed to support the NIGMS-aligned research of an independent investigator's laboratory. For research requiring financial support of collaborators and subcontractors, other funding mechanisms may be more appropriate.</p><p>Research involving human subjects is permitted in the MIRA program. Clinical research must be completely within the context of the research areas supported by NIGMS, which include several specific <a href="https://www.nigms.nih.gov/Research/specificareas/Pages/ClinicalResearchAreas.aspx">clinical areas</a>: anesthesiology, perioperative pain, clinical pharmacology, sepsis, injury and critical illness, wound healing, innate immunity and inflammation. Clinical research that involves recruitment of human subjects at more than one site or the substantial financial support of multiple collaborators and subcontractors is not allowed, because these fixed commitments are not consistent with the highly flexible nature of the MIRA program. <a href="https://grants.nih.gov/grants/glossary.htm#MechanisticStudy">Mechanistic</a> <a href="https://grants.nih.gov/grants/glossary.htm#ClinicalTrial">clinical trials</a> are permitted in MIRA when the mechanistic study is an essential part of the research program. Clinical trials that are designed to test safety and efficacy of interventions (Phase I, Phase II, Phase III) for the purpose of future clinical treatment and/or regulatory approval are not permitted in MIRA. Studies that propose clinical dissemination and implementation research, comparative effectiveness research, and/or pragmatic clinical trials are also not permitted.</p><p>Potential applicants are strongly encouraged to confer with the NIGMS <a href="https://www.nigms.nih.gov/about/pages/contactbyarea.aspx">program official</a> managing their qualifying award(s) or relevant research portfolio(s), or for additional questions, the Scientific/Research Contacts listed in this NOFO (in <a href="https://public.era.nih.gov/foa/docTemplates/55896/exportDocument/html/foaRequest.era?tracking=true#_Section%20VII.%20Agency%20Contacts">Section VII. Agency Contacts</a>) before submitting a MIRA application. NIGMS will not fund applications containing research projects that align with the missions of other NIH Institutes and Centers or federal agencies.</p><p><strong>Overlap During Peer Review</strong></p><p>Since a MIRA is designed to provide support for a PD's/PI's entire NIGMS-mission-aligned research program, it will overlap with most other NIGMS research grant applications. Therefore, a PD/PI may not have a MIRA application and another NIGMS research project grant application (e.g., R01, R15, R21, and R37) pending review at the same time. An application is pending review until its summary statement is issued. The following NIGMS applications are exempted from this policy:</p><ul><li>Grants supporting resources for the research community (e.g., R24 grants)</li><li>Collaborative Program Grant for Multidisciplinary Teams (RM1) grants;</li><li>Biomedical Technology Optimization and Dissemination (RM1) grants; </li><li>Training or workforce development;</li><li>Multi-site <a href="https://www.nigms.nih.gov/Research/clinicaltrials/pages/investigatorapps.aspx">clinical research</a>, both clinical trials and observational studies, with costs for patient recruitment, protocol-related expenses, and/or community resource activities (e.g., specimen banking, dissemination);</li><li>INBRE, COBRE, IDeA-CTRs, SEPA, and NARCH;</li><li>SBIR/STTR ;</li><li>Conference.</li></ul><p><strong>Resolving Overlap with Other NIGMS Research Grants During the Award Process</strong></p><p>A PD/PI awarded a MIRA must discontinue funding from other NIGMS research grants, except in specific situations as noted below. The following scenarios provide examples of how funding overlaps are addressed:</p><ul><li>A PD/PI receiving support as a collaborator or subcontractor on another investigator's NIGMS research project grant (e.g., R01, R15, R21, and R37) must discontinue such funding.</li><li>A PD/PI serving as a Project Leader or multiple PD/PI on a NIGMS multi-component grant or a Collaborative Program Grant for Multidisciplinary Teams (RM1), will have their MIRA award level adjusted to eliminate overlap. The PD/PI must discontinue funding from the multi-component grant at the end of its competitive segment. The PD/PI may continue to serve as a Project Leader or multi-PD/PI while maintaining at least 45% effort on the MIRA, but may not receive additional funds from the multi-component grant. NIGMS encourages collaborative and interdisciplinary research, and MIRA PDs/PIs may use MIRA funds to support their contributions for team-based research with other investigators. </li><li>A PD/PI serving as a PD/PI or subsection lead on a Biomedical Technology Optimization and Dissemination (BTOD) (RM1) grant may retain BTOD funding but must use it exclusively for late-stage technology optimization and dissemination efforts in their laboratory. MIRA funds may be used to support early-stage technology development efforts. The PD/PI must maintain at least 45% effort on their MIRA and commit at least 3 person-months to the BTOD grant if serving as a PD/PI, or at least 1 person-month if serving as a lead investigator for technology optimization projects (TOPs) or community engagement (CE). </li><li>A PD/PI with a NIGMS K award must discontinue the K award prior to the MIRA start date. A PD/PI with a K award from another NIH institute and Center may receive a MIRA but must reduce effort on the K award to be less than the effort committed to the MIRA (measured in person-months). </li></ul><p>NIGMS will facilitate an orderly process to transition to MIRA funding when reductions in other commitments are required. Specific details will be provided by NIGMS staff on a case by case basis.</p><p>The MIRA budget will be determined by NIGMS staff, based upon the PD's/PI's prior NIGMS funding history, recommendations from the peer review group and the National Advisory General Medical Sciences Council, and the expected productivity and impact of the proposed research program. MIRA applications from PDs/PIs whose total research support from all sources exceeds $1,500,000 in annual total costs are subjected to NIGMS' <a href="https://www.nigms.nih.gov/Research/Pages/unrestricted-support">Special Council Review</a> policy.</p><p>A PD/PI with more than $400,000 in direct costs from NIGMS research grants will generally receive a MIRA budget that is approximately 12% lower than the PD's/PI's average NIGMS research funding levels over recent years (as determined by NIGMS staff). MIRA budgets for New Investigators will generally be $275,000 in annual direct costs.</p><p>Budgets for MIRA renewals are determined independently based on a variety of considerations, including peer review outcomes, the PD's/PI’s other support and commitments, NIGMS' scientific priorities, and available budget. Overall, most MIRA renewal budgets are expected to be comparable to prior funding periods, though some may increase or decrease. For more information, see this <a href="https://nigms.nih.gov/loop/2022/02/mira-renewals-award-rates-and-budget-changes">Feedback Loop Post</a>.</p><p><strong>Applying for Subsequent Awards after Receiving a MIRA</strong></p><p>NIGMS will not accept assignment of an <a href="https://commonfund.nih.gov/tra">NIH Director's Transformative Research Award (TRA)</a> R01 or <a href="https://commonfund.nih.gov/pioneer">NIH Director's Pioneer Award (DP1)</a> application if the PD/PI has a MIRA, since by virtue of assignment to NIGMS, the proposed research falls within the mission of NIGMS and would by definition overlap with the MIRA.</p><p><strong>Supplements to MIRAs:</strong> </p><p>MIRA grants are eligible for <a href="https://www.nigms.nih.gov/Research/supplements/Pages/default">administrative supplements</a> offered by NIGMS, depending on the specific supplement program's intent and constraints.</p><p><strong>Renewals:</strong> </p><p>MIRA renewals are expected to have higher success rates compared to R01s due to the Institute's commitment to the program as well as the consolidation of separate research projects, which will result in fewer applications. If a MIRA renewal application is unsuccessful, the grant will terminate at the end of its approved project period. A <a href="https://grants.nih.gov/grants/glossary.htm#Resubmission">resubmission</a> (A1) application is not allowed; however, a PD/PI may submit a new MIRA application as long as they are eligible. </p><p>Any MIRA application submitted after a prior renewal's pending review must be a new application. However, if a renewal application is withdrawn prior to peer review, another renewal can be submitted in its place.</p>
</div>
<div data-element-id="261409" data-element-has-label="false" data-element-required="false" data-element-has-value="true" data-section-code="FOD" data-element-type="TEXT">
<a id='_bookmark261409' 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="261410" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="FOD" data-element-type="TEXT">
<a id='_bookmark261410' tabindex='-1' aria-hidden='true'></a><p>See <suggestion-start name="formatInline:hqnoervnq67p:ec8d3ac59f6905259a1c210505ec35ba6:SOLISA_188"></suggestion-start><a href="#_Section_VIII._Other">Section VIII. Other Information</a><suggestion-end name="formatInline:hqnoervnq67p:ec8d3ac59f6905259a1c210505ec35ba6:SOLISA_188"></suggestion-end> for award authorities and regulations.</p>
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<div data-element-id="261411" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="AI" data-element-type="TEXT">
<a id='_bookmark261411' tabindex='-1' aria-hidden='true'></a><a name="_Section II. Award Information"></a><h2>Section II. Award Information</h2>
</div>
<div class="row" data-index="40">
<div class="col-md-4 datalabel" tabindex="0" data-element-id="261412" data-element-required="true" data-element-has-value="true" data-section-code="AI" data-element-type="TEXT">
<a id='_bookmark261412' 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>
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</div>
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<div class="col-md-4 datalabel" tabindex="0" data-element-id="261413" data-element-required="true" data-element-has-value="true" data-section-code="AI" data-element-type="LINKED_ELEMENT">
<a id='_bookmark261413' tabindex='-1' aria-hidden='true'></a> Application Types Allowed
</div>
<div class=" col-md-8 datacolumn">
New
<br>
Renewal
<br>
Revision
<br>
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</div>
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<div class="col-md-push-4 col-md-8 datacolumn">
<a id='_bookmark261415' 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 <a href="https://grants.nih.gov/grants/guide/url_redirect.htm?id=82400">How to Apply - Application Guide</a> provide details on these application types. Only those application types listed here are allowed for this NOFO.</p>
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<div class="col-md-4 datalabel" tabindex="0" data-element-id="261416" data-element-required="false" data-element-has-value="true" data-section-code="AI" data-element-type="TEXT">
<a id='_bookmark261416' 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>
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<div class="col-md-push-4 col-md-8 datacolumn">
<a id='_bookmark261417' 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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<div class="col-md-4 datalabel" tabindex="0" data-element-id="261418" data-element-required="true" data-element-has-value="true" data-section-code="AI" data-element-type="TEXT">
<a id='_bookmark261418' tabindex='-1' aria-hidden='true'></a>Funds Available and Anticipated Number of Awards
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<div class=" col-md-8 datacolumn">
<p>The number of awards is contingent upon NIGMS appropriations and the submission of a sufficient number of meritorious applications.</p>
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<div class="col-md-4 datalabel" tabindex="0" data-element-id="261419" data-element-required="true" data-element-has-value="true" data-section-code="AI" data-element-type="TEXT">
<a id='_bookmark261419' tabindex='-1' aria-hidden='true'></a>Award Budget
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<div class=" col-md-8 datacolumn">
<p>Applications from investigators with existing NIGMS research grants may request up to $750,000 direct costs per year. Investigators should request well-justified costs that are aligned with their proposed research program, noting that efficient use of funds is an expectation of the MIRA program. Budget justification is considered during the review process and in making funding decisions. Generally, awards will be commensurate with the PD's/PI’s average total NIGMS research funding over the past few years.</p><p>For new applications from PDs/PIs previously funded through NIGMS R01-equivalents other than MIRAs, well-justified budget increases may be considered for PDs/PIs previously supported by budgets below $275,000 in annual direct costs, while modest reductions of approximately 12% on average, are expected for PDs/PIs with $400,000 or more in annual direct costs from NIGMS. The MIRA budget will typically be lower than an NIH <a href="https://commonfund.nih.gov/tra">Transformative Research Award</a> and will be significantly reduced from an <a href="https://commonfund.nih.gov/pioneer">NIH Director's Pioneer Award</a> (DP1).</p><p>MIRA budgets for New Investigators are typically set at $275,000 in annual direct costs, not including equipment.</p><p>For MIRA renewal applications, NIGMS expects that the award level may vary based on the justification and available funds. Meritorious renewal applications that are not prioritized for full funding may receive reduced budgets.</p><p>Equipment should be requested in Year 1 only. Unless equipment costs are requested, annual direct costs will remain constant throughout the award period.</p>
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<div class="row" data-index="48">
<div class="col-md-4 datalabel" tabindex="0" data-element-id="261420" data-element-required="true" data-element-has-value="true" data-section-code="AI" data-element-type="TEXT">
<a id='_bookmark261420' tabindex='-1' aria-hidden='true'></a>Award Project Period
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<div class=" col-md-8 datacolumn">
<p class="Normal">Applications may request a maximum project period of five years.</p>
</div>
</div>
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<div data-element-id="261421" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="AI" data-element-type="TEXT">
<a id='_bookmark261421' 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='_bookmark261422' 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='_bookmark261423' tabindex='-1' aria-hidden='true'></a><h4>1. Eligible Applicants</p>
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<div class="heading4" tabindex="0" data-element-id="261424" data-element-required="true" data-element-has-value="true" data-section-code="EI" data-element-type="TEXT">
<a id='_bookmark261424' tabindex='-1' aria-hidden='true'></a>Eligible Organizations
</div>
<div data-element-id="261424" 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>
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<a id='_bookmark261425' 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="261426" data-element-has-label="false" data-element-required="false" data-element-has-value="true" data-section-code="EI" data-element-type="TEXT">
<a id='_bookmark261426' 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>
</ul>
</div>
<div data-element-id="261427" data-element-has-label="false" data-element-required="false" data-element-has-value="false" data-section-code="EI" data-element-type="TEXT">
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<a id='_bookmark261428' tabindex='-1' aria-hidden='true'></a><h4>Foreign Organizations/Foreign Collaborations</h4>
</div>
<div data-element-id="261429" 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='_bookmark261429' tabindex='-1' aria-hidden='true'></a><p class="Normal">Non-domestic (non-U.S.) Entities (Foreign Organizations) <strong>are not</strong> eligible to apply.</p>
</div>
<div data-element-id="261430" 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='_bookmark261430' tabindex='-1' aria-hidden='true'></a><p>Non-domestic (non-U.S.) components of U.S. Organizations <strong>are not</strong> eligible to apply.</p>
</div>
<div data-element-id="261431" data-element-has-label="false" data-element-required="true" data-
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