Resource-Related Research Projects for Development of Models and Related Materials for Studying Human Health and Diseases (R24 Clinical Trials Not Allowed)

Q: When is the deadline for Resource-Related Research Projects for Development of Models and Related Materials for Studying Human Health and Diseases (R24 Clinical Trials Not Allowed)?

The deadline is September 28, 2028.

Overview

The Office of Research Infrastructure Programs (ORIP) encourages grant applications aimed at developing, characterizing, or improving research models of human health and diseases; developing biology based new approach methodologies (NAMs) applicable to human health and diseases; or improving access to information about or generated from the use of models of human disease. The models, including NAMs, and related biological materials developed must be broadly applicable to the scientific interests of two or more NIH Institutes or Centers (ICs) and must evaluate diseases and processes that impact multiple organ systems in order to align with the ORIP"s NIH-wide mission and programs. Applications must describe the need for and the potential impact of the proposed resources on the research community across a range of scientific disciplines supported by multiple NIH ICs. Applications to develop models that relate strictly to a specific disease or a select area of research or that do not have a broad impact on the NIH-wide research community will not be accepted. Projects that predominantly address the research interests of one NIH IC but are only peripherally related to the research interests of other ICs will also not be accepted, if submitted in response to this notice of funding opportunity (NOFO).

Details

Agency: National Institutes of Health
Department: Department of Health and Human Services
Opportunity #: RFA-OD-25-010
Total Funding: $5,000,000
Expected Awards: 6
Instrument: grant

Eligibility

Refer to Section III. Eligibility Information of 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 not allowed.

Eligibility

Eligible Applicant Types

city_or_township_governmentsothernonprofits_non_higher_education_without_501c3private_institutions_of_higher_educationcounty_governmentspublic_and_state_institutions_of_higher_educationfor_profit_organizations_other_than_small_businessesfederally_recognized_native_american_tribal_governmentsstate_governmentssmall_businessesnonprofits_non_higher_education_with_501c3

How to Apply

RFA-OD-25-010-Full-Announcement.html

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<title>RFA-OD-25-010: Resource-Related Research Projects for Development of Models and Related Materials for Studying Human Health and Diseases (R24 Clinical Trials Not Allowed)</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='_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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<p>Division of Program Coordination, Planning and Strategic Initiatives, Office of Research Infrastructure Programs (<a href="https://orip.nih.gov/" target="_blank" rel="noreferrer">ORIP</a>)

<p>All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.
</p>
<p>INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (<a href="https://www.nih.gov/include-project" target="_blank" rel="noreferrer">INCLUDE Project</a>)
</p>
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<a id='_bookmark261378' tabindex='-1' aria-hidden='true'></a>Funding Opportunity Title
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<div class=" col-md-8 datacolumn">
<span class="title">Resource-Related Research Projects for Development of Models and Related Materials for Studying Human Health and Diseases (R24 Clinical Trials Not Allowed)</span>
</div>
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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=r24&Search.x=0&Search.y=0&Search_Type=Activity">R24</a> Resource-Related Research Projects</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/rfa-files/RFA-OD-22-013.html" target="_blank" rel="noreferrer">RFA-OD-22-013</a>

<br/>
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<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>
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<a id='_bookmark261382' tabindex='-1' aria-hidden='true'></a>Funding Opportunity Number (FON)
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<div class=" col-md-8 datacolumn">
<span class="noticenum">RFA-OD-25-010</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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93.351
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<a id='_bookmark261386' tabindex='-1' aria-hidden='true'></a>Funding Opportunity Purpose
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<div class=" col-md-8 datacolumn">
<p style="margin-left:0in;">The Office of Research Infrastructure Programs (<a href="https://orip.nih.gov/">ORIP</a>) encourages grant applications aimed at developing, characterizing, or improving research models of human health and diseases; developing biology based new approach methodologies (NAMs) applicable to human health and diseases; or improving access to information about or generated from the use of models of human disease. The models, including NAMs, and related biological materials developed must be broadly applicable to the scientific interests of two or more NIH Institutes or Centers (ICs) and must evaluate diseases and processes that impact multiple organ systems in order to align with the ORIPs NIH-wide mission and programs. Applications must describe the need for and the potential impact of the proposed resources on the research community across a range of scientific disciplines supported by multiple NIH ICs. Applications to develop models that relate strictly to a specific disease or a select area of research or that do not have a broad impact on the NIH-wide research community will not be accepted. Projects that predominantly address the research interests of one NIH IC but are only peripherally related to the research interests of other ICs will also not be accepted, if submitted in response to this notice of funding opportunity (NOFO).</p>
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<a id='_bookmark261388' tabindex='-1' aria-hidden='true'></a>Funding Opportunity Goal(s)
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<div class=" col-md-8 datacolumn">
<p>The Office of Research Infrastructure Programs (ORIP) is a program office in the Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI) dedicated to supporting research infrastructure and related research resource programs. ORIP consists of the Division of Comparative Medicine (DCM) and the Division of Construction and Instruments (DCI).</p>
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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">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>
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<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>
September 28, 2026
</td>
<td>
September 28, 2026
</td>
<td>
Not Applicable
</td>
<td>March 2027</td>
<td> May 2027

</td>
<td>July 2027</td>
</tr>
<tr>
<td>
January 26, 2027
</td>
<td>
January 26, 2027
</td>
<td>
Not Applicable
</td>
<td>July 2027</td>
<td> October 2027

</td>
<td>December 2027</td>
</tr>
<tr>
<td>
May 26, 2027
</td>
<td>
May 26, 2027
</td>
<td>
Not Applicable
</td>
<td>November 2027</td>
<td> January 2028

</td>
<td>April 2028</td>
</tr>
<tr>
<td>
September 28, 2027
</td>
<td>
September 28, 2027
</td>
<td>
Not Applicable
</td>
<td>March 2028</td>
<td> May 2028

</td>
<td>July 2028</td>
</tr>
<tr>
<td>
January 26, 2028
</td>
<td>
January 26, 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>
<tr>
<td>
September 28, 2028
</td>
<td>
September 28, 2028
</td>
<td>
Not Applicable
</td>
<td>March 2029</td>
<td> May 2029

</td>
<td>July 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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September 29, 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 class="Normal">Not Applicable</p>
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<a id='_bookmark262221' tabindex='-1' aria-hidden='true'></a>Required Application Instructions
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<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>

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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>
</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><p style="margin-left:0in;">Experimental research models are indispensable for studying the genetic basis and pathobiological mechanisms underlying human diseases, identifying drug targets, and developing effective preventive and therapeutic approaches. Human health and disease-related resources include biology-based new approach methodologies (NAMs); naturally occurring mutant and genetically modified animals; related biological materials, such as nucleic acids, proteins, cell cultures, and tissues; reagents; and knowledge of an animals genome, life cycle, molecular, cellular and physiological phenotypes, and behaviors. Resources can also include information needed for optimal use of animal models, such as physical and genetic maps or computer models. <a href="https://orip.nih.gov/">ORIP</a> supports development, maintenance, and distribution of these various types of resources related to models of human disease encompassing animals, small model organisms, and in particular NAMs that are reflective of human biology and pathophysiology.</p><p style="margin-left:0in;"><strong>Purpose and Scope</strong></p><p style="margin-left:0in;">ORIPs intent with this NOFO is to support resource-related research projects that are aimed at developing and characterizing new human health- and disease-based resources, improving existing resources, or acquiring deep understanding of a model system to improve the utilization, accessibility, and translational value of experimental research models to the research community. The NIH-wide mission of ORIP is to support all NIH ICs that fund basic, preclinical, and translational research by strengthening their existing programs, developing research resources, advancing areas of emerging science, and developing new initiatives to move biomedical research forward. Therefore, proposed studies, models, technologies, methodologies, and biological materials must be applicable to two or more NIH ICs and must explore multiple organ systems or evaluate diseases and processes that impact multiple organ systems.</p><p style="margin-left:0in;">An application under this NOFO may be predominantly research based if that research potentially leads to the development of tools or resources that will have a broad impact on the NIH-wide biomedical research community. An application also may be aimed at final development or enhancement of existing resources.</p><p style="margin-left:0in;">Applications responding to this NOFO should:</p><ul><li>Demonstrate the need for the proposed resources or technologies/tools within broad biomedical research communities and the relevance of the resources and technologies/tools to a range of scientific disciplines.</li><li>Address the impact, benefit, utilization, distribution, and accessibility of the proposed resources and technologies/tools to broad biomedical research areas supported by multiple NIH ICs.</li><li>Describe plans to track potential impact of the proposed resources and technologies/tools.</li><li>Describe potential sources of support for the resources and technologies/tools as well as plans to ensure the continued availability of the resources and technologies/tools to the research community after the ORIP-supported grant ends, such as plans to deposit the resources to stock centers or databases accessible to the research community.</li><li>Include a replication and validation plan for proposed models or related resources to be developed.</li></ul><p style="margin-left:0in;">Cost recovery is not required for applications responding to this NOFO.</p><p style="margin-left:0in;">Proposed studies, models, technologies, methodologies, and biological materials that relate strictly to a specific disease or research discipline or are relevant to the mission and programs of a single NIH IC will not be considered suitable for this NOFO. Such applications should be directed to the IC with a specific interest in that mission. For example, investigators interested in developing resources with a primary focus on aging, cancer, cardiovascular disease, infectious disease, or neurological disorders should contact respective NIH ICs relevant to these topics. Furthermore, applications proposing studies to develop a limited number of resources or are related primarily to the interest of one NIH IC and only peripherally to the interests of other ICs are not acceptable.</p><p style="margin-left:0in;">Proposed projects under this NOFO should be aimed at generating a substantial amount of human health and disease model related resources and information with broad impacts. Examples of resource-related projects suitable for this NOFO, include, but are not limited to:</p><ul><li>Development of new approach methodologies (NAMs), including laboratory (<i>in vitro</i> or <i>in chemico)</i>, computer-based (<i>in silico)</i>, or hybrid methods—advancing our ability to simulate physiological and disease processes. These tools aim to model the complex interactions among molecules, cells, tissues, and organs outside of the whole organism, and serve as valuable complements to animal research. Rigorous testing and validation of these models to demonstrate reliability, reproducibility, and human biological relevance is essential.</li><li>Development of informatics tools or systems biology approaches, especially artificial intelligence or machine learning tools, that integrate various types of data, including genomic, proteomic, metabolomic, imaging, or phenotypic data, to generate novel hypotheses and improve the value of human health and disease models for biomedical research.</li><li>Development, improvements or refinements of technologies or methods applicable to human health and disease model research that aim to enhance its rigor and reproducibility.</li><li>Generation of mutant or transgenic animal models for studying fundamental biological processes and investigating mechanisms underlying a broad range of human diseases that impact multiple organ systems.</li><li>Production of antibodies or other reagents and demonstration of their utility for quantifying or characterizing macromolecules or cells in animal models of a variety of human diseases.</li><li>Development of information resources for generating novel hypotheses and improving the utilization of animals in biomedical research, including deep phenotyping of organelles, single cells, cellular networks, microbiomes, or behaviors.</li><li>Development of genetic, genomic, proteomic, metabolomic or phenomic tools for deep characterization and understanding of disease-related biological processes.</li><li>Generation of genetic resources at the genome scale, including DNA or viral vector libraries, for gene editing of cell lines, germplasm, or somatic cells.</li><li>Development of methods or tools for improving cryopreservation, or other long-term preservation approaches, of animal cells, germplasm, embryos, or genetic stocks.</li><li>Development of methods or tools for characterizing stem cells and advancing techniques of regenerative medicine. These include stem cell generation, reprogramming, characterization, and transplantation; stem cell-based therapeutic applications; and analysis of the safety of newer technologies such as RNA-guided endonucleases (CRISPR/Cas9), optogenetics/chemogenetics, and humanized animal models generated with non-fetal human tissues.</li><li>Generation of models or resources that can contribute to the understanding of newly emerging human pathogens of interest to multiple NIH ICs and may be applied in response to pandemics and other active NIH-wide public health initiatives.</li></ul><p style="margin-left:0in;">Applications for developing a limited number of resources are not suitable for this NOFO and may be appropriate for <a href="https://orip.nih.gov/funding">research project grant activities through R21 or R01</a> awards supported by ORIP or NIH ICs. Examples of projects that WILL NOT be supported under this NOFO include those that:</p><ul><li>Develop experimental models, cell lines, or NAMs that relate strictly to a specific disease or research area or are primarily relevant to the mission and programs of predominantly one NIH IC.</li><li>Develop cell lines of a single cell type that relate strictly to a specific disease or research area, or that are primarily relevant to the mission and programs of predominantly one NIH IC.</li><li>Primarily focus on husbandry and management of animal colonies.</li><li>Primarily focus on genomic sequencing of model organisms (e.g., only for data deposition into a repository).</li><li>Primarily focus on creating, expanding, or maintaining genomic or other types of databases.</li><li>Create or maintain individual model organism databases.</li><li>Develop or distribute wild-type animals and related biospecimens treated with diet, drug, toxin, infectious agents, or other environmental factors.</li><li>Develop or distribute wild-type animals and related biospecimens subjected to physical or surgical manipulations.</li><li>Involve threatened or endangered species.</li><li>Develop, expand, or maintain repositories of specific tissues and related bio-specimens (i.e. RNA extracts, processed tissues) from model organisms.</li><li>Primarily involve human subjects, human cell lines, or related human biological materials.</li></ul><p style="margin-left:0in;">This NOFO will support the development of human health and disease models and related resources to advance a variety of important research areas and have an impact on the NIH-wide biomedical research community. Those applications proposing to develop resources should describe plans to deposit their resources to stock centers or databases accessible to the research community and register their resources with current resource tagging and identification initiatives, such as <a href="https://www.force11.org/">FORCE 11</a>. These projects should also encourage investigators who use the resources to make use of the <a href="https://www.scicrunch.com/">Research Resource Identifiers (RRIDs)</a> in their publications and reports.</p><p style="margin-left:0in;">Program Directors/Principal Investigators (PD/PIs) planning to work with their institutions to submit applications to this NOFO are strongly encouraged to contact the scientific contacts prior to submission (see Scientific/Research Contacts in Section VII. Agency Contacts) to receive guidance on appropriateness of the intended resource and research plans for this program, competitiveness of a potential application, and alignment with ORIP's program priorities.</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 <a href="#_Section_VIII._Other">Section VIII. Other Information</a> for award authorities and regulations.</p>
</div>

<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>
</div>
</div>

<div class="row" data-index="41">
<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>
Resubmission
<br>
Revision
<br>
</div>
</div>

<div class="row" data-index="43">
<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>
</div>
</div>

<div class="row" data-index="44">
<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>Not Allowed: Only accepting applications that do not propose clinical trials.</p>
</div>
</div>

<div class="row" data-index="45">
<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>
</div>
</div>

<div class="row" data-index="46">
<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
</div>
<div class=" col-md-8 datacolumn">
<p>Contingent upon NIH appropriations and the submission of meritorious applications, NIH intends to commit $5,000,000 per fiscal year in FY 2026-2029 to fund at least six awards per fiscal year, including Down Syndrome related awards if there are any.</p>
</div>
</div>

<div class="row" data-index="47">
<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
</div>
<div class=" col-md-8 datacolumn">
<p style="margin-left:0in;">Application budgets are not limited but need to reflect the actual needs of the proposed project.</p><p>Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) should refer to <a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-23-075.html">NOT-OD-23-075</a> and must contact a Scientific/ Research Contact for approval at least 6 weeks before submitting the new or renewal application.</p><p>For Renewal (a.k.a. Type 2) applications including Renewal Resubmission applications, no more than a 5 percent increase of direct cost based on a previous non-competing year with the highest direct cost in the prior four-year funding cycle will be accepted.</p>
</div>
</div>

<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
</div>
<div class=" col-md-8 datacolumn">
<p class="Normal">The duration of the proposed project may not exceed four years.</p>
</div>
</div>

<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>

<div data-element-id="261422" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="EI" data-element-type="TEXT">
<a id='_bookmark261422' tabindex='-1' aria-hidden='true'></a><a name="_Section III. Eligibility Information"></a><h2>Section III. Eligibility Information</h2>
</div>

<div data-element-id="261423" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="EI" data-element-type="TEXT">
<a id='_bookmark261423' tabindex='-1' aria-hidden='true'></a><h4>1. Eligible Applicants</p>
</div>

<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>Indian/Native American Tribal Governments (Federally Recognized)</li><li>Indian/Native American Tribal Governments (Other than Federally Recognized)</li></ul>
</div>

<div data-element-id="261425" data-element-has-label="false" data-element-required="false" data-element-has-value="true" data-section-code="EI" data-element-type="TEXT">
<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="261428" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="EI" data-element-type="TEXT">
<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-element-has-value="true" data-section-code="EI" data-element-type="RADIO_BUTTON">
<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 not</strong> allowed. </p>
</div>

<div class="heading4" tabindex="0" data-element-id="261432" data-element-required="true" data-element-has-value="true" data-section-code="EI" data-element-type="TEXT">
<a id='_bookmark261432' tabindex='-1' aria-hidden='true'></a>Required Registrations
</div>

<div data-element-id="261432" data-element-has-label="true" data-element-required="true" data-element-has-value="true" data-section-code="EI" data-element-type="TEXT">
<p><strong>Applicant Organizations</strong></p>

<p>Applicant organizations must complete and maintain the following registrations as described in the <a href="https://grants.nih.gov/grants/guide/url_redirect.htm?id=82400">How to Apply - Application Guide</a> 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 <a href="http://grants.nih.gov/grants/guide/url_redirect.htm?id=82423">NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications</a> for additional information</p>

<ul>
<li><a href="https://grants.nih.gov/grants/guide/url_redirect.htm?id=82390">System for Award Management (SAM) –</a> Applicants must complete and maintain an active registration, <strong>which requires renewal at least annually</strong>. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.

<ul>
<li><a href="http://grants.nih.gov/grants/guide/url_redirect.htm?id=11176">NATO Commercial and Government Entity (NCAGE) Code</a> – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.</li>
<li>Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.</li>
</ul>
</li>
<li><a href="https://grants.nih.gov/grants/guide/url_redirect.htm?id=11123">eRA Commons</a> - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.</li>
<li><a href="http://grants.nih.gov/grants/guide/url_redirect.htm?id=82300">Grants.gov</a> – Applicants must have an active SAM registration in order to complete the Grants.gov registration.</li>
</ul>

<p><strong>Program Directors/Principal Investigators (PD(s)/PI(s))</strong></p>

<p>All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.</p>
</div>

<div class="heading4" tabindex="0" data-element-id="261433" data-element-required="true" data-element-has-value="true" data-section-code="EI" data-element-type="TEXT">
<a id='_bookmark261433' tabindex='-1' aria-hidden='true'></a>Eligible Individuals (Program Director/Principal Investigator)
</div>

<div data-element-id="261433" data-element-has-label="true" data-element-required="true" data-element-has-value="true" data-section-code="EI" data-element-type="TEXT">
<p>Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as t

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