Impact of Initial Influenza Exposure on Immunity in Infants (U01 Clinical Trial Not Allowed)
National Institutes of Health
Funding Amount
Up to $3,000,000
Deadline
June 4, 2026
56 days left
Grant Type
federal
Overview
Impact of Initial Influenza Exposure on Immunity in Infants (U01 Clinical Trial Not Allowed)
The purpose of this notice of funding opportunity (NOFO) is to support the establishment or continuation of longitudinal infant cohorts to determine and compare how initial and repeated natural influenza infections and/or influenza vaccinations shape infant and childhood immunity to future influenza exposures. The goal of this research is to understand how these exposures influence immune responses to subsequent influenza infections and/or vaccines and provide key information to facilitate design of durable, broadly protective influenza vaccines.
Details
- Agency: National Institutes of Health
- Department: Department of Health and Human Services
- Opportunity #: RFA-AI-27-019
- Total Funding: $9,600,000
- Expected Awards: 3
- Instrument: cooperative_agreement
Eligibility
Refer to Section III. Eligibility Information in the NOFO for additional information on eligibility.Foreign Organizations/International CollaborationsNon-domestic (non-U.S.) Entities (Foreign Organizations) are eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.Foreign components, as defined in the NIH Grants Policy Statement, are allowed.NIH will no longer issue awards (i.e., new, renewal, or non-competing continuation) to domestic or foreign entities that involve foreign subawards/subcontracts. All NIH-funded research involving foreign subawards/subcontracts must be submitted in response to a NOFO that is specifically designated for funded international collaborations. This new requirement was effective, May 1, 2025.Applications involving foreign subawards/subcontracts submitted in response to this NOFO will be deemed noncompliant and will not be considered for funding. This policy applies to all monetary international collaborations resu
Eligibility
Eligible Applicant Types
How to Apply
RFA-AI-27-019-Full-Announcement.html
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<title>RFA-AI-27-019: Impact of Initial Influenza Exposure on Immunity in Infants (U01 Clinical Trial Not Allowed)</title>
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<div id="page-title" class="heading1" tabindex="0">Department of Health and Human Services</div>
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<a id='_bookmark261213' tabindex='-1' aria-hidden='true'></a><a name="_Part 1. Overview Information"></a><h1>Part 1. Overview Information</h1>
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<p>National Institutes of Health (<a href="http://www.nih.gov">NIH</a>)</p>
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<a id='_bookmark261216' tabindex='-1' aria-hidden='true'></a>Components of Participating Organizations
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<p>National Institute of Allergy and Infectious Diseases (<a href="https://www.niaid.nih.gov/" target="_blank" rel="noreferrer">NIAID</a>)
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<a id='_bookmark261218' tabindex='-1' aria-hidden='true'></a>Funding Opportunity Title
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<span class="title">Impact of Initial Influenza Exposure on Immunity in Infants (U01 Clinical Trial Not Allowed)</span>
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<a id='_bookmark261219' tabindex='-1' aria-hidden='true'></a>Activity Code
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<p><a href="http://grants.nih.gov/grants/funding/ac_search_results.htm?text_curr=u01&Search.x=0&Search.y=0&Search_Type=Activity">U01</a> Research Project – Cooperative Agreements</p>
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<a id='_bookmark261220' tabindex='-1' aria-hidden='true'></a>Announcement Type
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Reissue of
RFA-AI-18-010
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<a id='_bookmark261221' tabindex='-1' aria-hidden='true'></a>Related Notices
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<ul><li>Check for any recent <a href="https://grants.nih.gov/grants/guide/url_redirect.php?id=11163">Notices of NIH Policy Changes</a> that may impact application requirements.</li></ul>
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<a id='_bookmark261222' tabindex='-1' aria-hidden='true'></a>Funding Opportunity Number (FON)
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<span class="noticenum">RFA-AI-27-019</span>
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<a id='_bookmark261223' tabindex='-1' aria-hidden='true'></a>Companion Funding Opportunity
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None
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<a id='_bookmark261224' tabindex='-1' aria-hidden='true'></a>Number of Applications
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<p>See Part 2, Section III. 3. Additional Information on Eligibility.</p>
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<a id='_bookmark261225' tabindex='-1' aria-hidden='true'></a>Assistance Listing Number(s)
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93.855
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<a id='_bookmark261226' tabindex='-1' aria-hidden='true'></a>Funding Opportunity Purpose
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<p>The purpose of this notice of funding opportunity (NOFO) is to support the establishment or continuation of longitudinal infant cohorts to determine and compare how initial and repeated natural influenza infections and/or influenza vaccinations shape infant and childhood immunity to future influenza exposures. The goal of this research is to understand how these exposures influence immune responses to subsequent influenza infections and/or vaccines and provide key information to facilitate design of durable, broadly protective influenza vaccines.</p>
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<a id='_bookmark261228' tabindex='-1' aria-hidden='true'></a>Funding Opportunity Goal(s)
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<p>To assist public and private nonprofit institutions and individuals to establish, expand and improve biomedical research and research training in infectious diseases and related areas; to conduct developmental research, to produce and test research materials. To assist public, private and commercial institutions to conduct developmental research, to produce and test research materials, to provide research services as required by the agency for programs in infectious diseases, and controlling disease caused by infectious or parasitic agents, allergic and immunologic diseases and related areas. Projects range from studies of microbial physiology and antigenic structure to collaborative trials of experimental drugs and vaccines, mechanisms of resistance to antibiotics as well as research dealing with epidemiological observations in hospitalized patients or community populations and progress in allergic and immunologic diseases. Because of this dual focus, the program encompasses both basic research and clinical research.</p>
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<a id='_bookmark261229' tabindex='-1' aria-hidden='true'></a><a name="_Key Dates"></a><h2>Key Dates</h2>
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February 10, 2026
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May 04, 2026
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June 04, 2026
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June 04, 2026
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<td> January 2027
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<td>March 2027</td>
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<a id='_bookmark261235' tabindex='-1' aria-hidden='true'></a><p>All applications are due by 5:00 PM local time of applicant organization. </p>
<p>Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.</p>
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<p>Not Applicable</p>
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June 05, 2026
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<p>It is critical that applicants follow the instructions in the Research (R) Instructions in the <a href="https://grants.nih.gov/grants/guide/url_redirect.htm?id=82400">How to Apply - Application Guide</a>, except where instructed to do otherwise (in this NOFO or in a Notice from <a href="http://grants.nih.gov/grants/guide/url_redirect.htm?id=11164">NIH Guide for Grants and Contracts</a>).</p>
<p>Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.</p>
<p><strong>Applications that do not comply with these instructions may be delayed or not accepted for review.</strong></p>
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<a id='_bookmark262235' tabindex='-1' aria-hidden='true'></a><p style="margin-left:0in;">There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You <strong>must</strong> use one of these submission options to access the application forms for this opportunity.</p><ol><li>Use the <a href="https://public.era.nih.gov/assist/landing.era?tabId=0819b5fc-46b7-4f02-b6b7-127e5a4e19fa">NIH ASSIST system</a> to prepare, submit and track your application online.</li><li>Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and <a href="https://public.era.nih.gov/commons/">eRA Commons</a> to track your application. Check with your institutional officials regarding availability.</li><li>Use <a href="https://grants.gov/search-grants?oppStatuses=closed|archived|posted|forecasted&fon=PA-25-301">Grants.gov</a> Workspace to prepare and submit your application and <a href="http://public.era.nih.gov/commons/">eRA Commons</a> to track your application.</li></ol>
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<div 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>
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<a id='_bookmark261245' tabindex='-1' aria-hidden='true'></a><a name="_Part 2. Full Text of Announcement"></a><h1>Part 2. Full Text of Announcement</h1>
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<a id='_bookmark261246' tabindex='-1' aria-hidden='true'></a><a name="_Section I. Notice of Funding Opportunity Description"></a><h2>Section I. Notice of Funding Opportunity Description</h2>
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<a id='_bookmark261247' tabindex='-1' aria-hidden='true'></a><h4 style="margin-left:0in;">Purpose</h4><p>The purpose of this notice of funding opportunity (NOFO) is to support the establishment or continuation of longitudinal infant cohorts to determine and compare how initial and repeated natural influenza infections and/or influenza vaccinations shape infant and childhood immunity to future influenza exposures. Research supported under this program will define and characterize immunity acquired upon initial exposure to influenza antigens from natural infections and/or vaccinations and examine how these exposures influence immune responses to subsequent influenza infections and/or vaccines. The goal of this research is to provide key information to facilitate design of durable, broadly protective influenza vaccines.</p><h4 style="margin-left:0in;">Background</h4><p>Seasonal influenza outbreaks occur annually and cause significant worldwide morbidity and mortality, particularly in vulnerable populations such as infants, young children, and the elderly. An even greater threat to the general population is the ever-present and unpredictable emergence of a novel viral strain for which humans may have limited to no pre-existing immunity. Because influenza viruses exhibit frequent antigenic change, influenza vaccines are developed against the strains predicted to circulate in the upcoming influenza season and novel strains that have the potential to widely infect humans. Therefore, annual vaccination remains the cornerstone for the control of influenza. Seasonal influenza vaccines typically contain two strains of influenza A (H1N1 and H3N2) virus and one or more influenza B viruses formulated as trivalent or quadrivalent vaccines, respectively. Currently available influenza vaccines provide suboptimal protection against seasonal influenza and provide limited protection against newly emerging strains. Numerous factors can significantly reduce vaccine effectiveness to circulating strains and contribute to waning immunity. A major advancement in influenza control would be the development of a vaccine that confers broad, robust, and durable protection against many or most seasonal strains of influenza, as well as novel strains that could cause significant morbidity and mortality in humans.</p><p>Humans encounter numerous influenza strains and may receive numerous vaccinations throughout their lifetime. Immune responses to these exposures are determined by the genetics of the infecting viruses and intrinsic factors, including host genetics, exposure and vaccination history, age, the presence or absence of chronic illnesses, and immune status. Additionally, one's initial infection with an influenza virus impacts immunity, including antibody responses, to subsequent infections with new strains. This concept of "original antigenic sin" was proposed in 1960 by Thomas Francis, Jr. to describe the impact of pre-existing immunological memory from an initial influenza encounter upon exposure to a different influenza virus. Recent epidemiologic evidence suggests that exposure during early childhood elicits a lifelong immunologic "imprint" that impacts the response to subsequent novel strains, including providing protection against novel hemagglutinin (HA) subtypes from the same phylogenetic group as the original infecting virus. Immunological "imprinting" has important implications for public health because it may also negatively influence responses to subsequent influenza infections and vaccinations. A better understanding of “imprinting” could allow it potentially to be harnessed for future vaccine design that provides infants with a broader immune landscape and protection from subsequent infections.</p><p>Understanding how infants' immune responses are altered or expanded by their encounter with subsequent influenza infections and/or vaccinations will be critical to define the breadth of immunological coverage that can be achieved with an effective universal influenza vaccine. Detailed immunological studies of clinical samples from infants will provide new insights into the mechanisms by which immunity is acquired following initial exposure to influenza via infection or vaccination and help define which influenza antigen/epitope-associated responses result in more broad-based immunity. This initiative is intended to support the establishment or continuation of focused, multi-disciplinary, prospective studies of longitudinal infant cohorts and immunological research studies to address critical knowledge gaps.</p><h4 style="margin-left:0in;">Research Objectives and Scope</h4><p>Despite early exposure to natural influenza infections or vaccinations, influenza infections continue to occur throughout life. Numerous studies have shown that one's initial exposure to influenza impacts immunity to subsequent exposures with different influenza strains. However, the impact of initial influenza infections and/or vaccinations on immunity to subsequent influenza exposures is not well understood. This initiative responds to the need for increased investments in clinical and basic research in well-characterized infant cohorts by exploring the impact of birth year, initial and subsequent vaccinations, and natural infections on influenza immunity. Recent innovations in the study of human immunology coupled with other advanced technologies can be leveraged to determine the critical immune components required for generation, maintenance, and evolution of broadly protective immunity against influenza in humans. Specifically, this research initiative will support the establishment or continuation of infant cohorts coupled with immunological analyses to determine how initial natural influenza exposure and/or primary influenza vaccination shape infant and childhood immune responses to subsequent influenza infections and/or vaccines. The findings from this research will help to advance the design of a universal influenza vaccine.</p><p>This initiative will support a synergistic and cross-disciplinary effort to generate, coordinate, and integrate data from human clinical samples to address critical questions in influenza immune "imprinting" research. The study findings will be made available to the public as rapidly as possible. The clinical data and biological samples collected from the cohort(s) are expected to be available for sharing and use by the scientific community to continue research in this important field, as appropriate and consistent with achieving the goals of the program.</p><p>This NOFO requires applicants to establish or continue prospective cohort(s) of infants that will be followed prior to and after:</p><ul><li>receiving their initial influenza vaccination (i.e., clinician routinely recommended vaccine); and/or</li><li>having an initial documented clinical diagnosis of influenza infection (i.e., clinician confirmed, molecularly diagnosed, and subtyped confirmed) prior to receiving their initial influenza vaccination.</li></ul><p>Infant enrollment ideally should occur between birth and prior to initial influenza exposure. These cohorts are expected to be followed for at least three influenza seasons, with desired capabilities to follow for longer periods, to understand the impact of initial and subsequent influenza infections and/or vaccinations on the breadth and quality of influenza-specific humoral and T cell-mediated immune responses, as well as innate immune responses triggered by influenza vaccines or natural infections.</p><p>This program supports inclusion of domestic prospective cohorts and appropriate international cohorts, especially from countries where infection or vaccination rates complement those seen in the U.S. Inclusion of relevant international cohorts facilitates recruitment and retention of additional participants, allowing for experimental and statistical validation of research results and strengthening clinical applications.</p><p>Inclusion of pregnant women and post-partum mothers in the prospective cohorts is strongly encouraged. Pregnant women should be followed at least through the last trimester of pregnancy and post-partum mothers followed through infant weaning. Each mother's influenza exposure history (i.e., vaccine and natural infection) and circulating influenza-specific antibody responses should be captured during pregnancy, immediately post-partum, and through weaning in order to examine the effects of maternal influenza exposure and circulating maternal anti-influenza antibodies on infant immune responses to influenza vaccines or natural infection.</p><p>Areas of research <strong>must</strong> address both topics listed below (identified as 1 and 2):</p><p style="margin-left:18.75pt;">1. Determination of the effect of repeated exposures to infections and/or vaccinations on the maintenance and evolution of influenza-specific humoral and T cell-mediated immunity in infants/young children.</p><p style="margin-left:25px;">Within this topic, examples of areas of research include:</p><ul><li>Changes in antibody titer, specificity and function, including changes in post-translational modifications;</li><li>Impact on B cell subset generation and maintenance, including plasmablasts, long-lived plasma cells and memory B cells;</li><li>Impact on the differentiation, specificity, function and maintenance of effector and memory T cell populations;</li><li>Impact on the differentiation, specificity, and function of innate cell populations (e.g., trained immunity).<br> </li></ul><p style="margin-left:18.75pt;">2. Comparison of immune mechanisms/components elicited by influenza vaccination versus natural infection.</p><p style="margin-left:18.75pt;">Within this topic, examples of areas of research include:</p><ul><li>Understanding the cross-talk between components of innate and adaptive immunity elicited by influenza vaccination versus natural infection that impacts acquired influenza immunity;</li><li>Comparison of B cell and T cell responses elicited by influenza vaccination versus natural infection;</li><li>Comparison of the quality and functionality of antibodies induced by natural infections or vaccination, including hemagglutination inhibition assay (HAI), neutralizing antibody responses, neuraminidase antibody responses, as well as antibody-dependent cell-mediated cytotoxicity (ADCC), antibody-dependent cellular phagocytosis (ADCP), antibody-dependent complement deposition (ADCD), and stalk-binding assays;</li><li>Impact of other respiratory virus infections or routine childhood vaccinations on anti-influenza immunity;</li><li>Impact of maternal anti-influenza immune status on offspring’s immune response to initial influenza vaccine or infection (in neonatal period prior to weaning).</li></ul><p>The approach taken to establish, maintain, and characterize the cohort, including determination of the type of experimental and clinical data and biological samples to collect, should provide the greatest degree of innovation possible to advance our understanding of rational universal influenza vaccine design for this vulnerable population.</p><h4 style="margin-left:0in;">Program Infrastructure and Support</h4><p><strong>Administration and Leadership Team</strong><br>The Administration and Leadership Team, led by the Program Director(s)/Principal Investigator(s) [PD(s)/PI(s)], will be responsible for organizing, coordinating, and providing oversight for the implementation and execution of activities that facilitate progress and completion of the research project. This team will serve as the administrative oversight, coordination, and communications hub for the entire study. The Administration and Leadership Team will also work with the Data Stewardship and Analysis Team to develop efficient and statistically powered study designs and provide support for the preliminary and final data analyses for the research.</p><p><strong>Data Stewardship and Analysis Team</strong><br>The Data Stewardship and Analysis Team will be responsible for the range of activities related to data including: collection, management, analyses, quality assurance and standards, and development of statistically powered study designs for the study. The Data Stewardship and Analysis Team will also implement processes and procedures for receipt, storage, retrieval, and inventory of biological specimens, harmonization of specimens to clinical and experimental data (including metadata), tracking and monitoring of biological specimen use, storage, and/or distribution, and executing data sharing agreements among recipients of these awards, and for sharing of data/meta-data with the broader research community including public repositories recommended by NIAID program staff. Team members will work with key personnel to develop efficient study designs and statistical calculations and provide support for the preliminary and final data analyses for the study.</p><p><strong>Clinical Research Support Team</strong><br>The Clinical Research Support Team will be responsible for leading and coordinating the activities associated with human subjects’ research across the study, including for example, multi-site coordination, pre-study community outreach, tracking and monitoring enrollment, recruitment, maintenance, and status of regulatory documents with data collection and reporting, and compliance with human subjects’ research data and quality procedures. This team will serve as the process and procedure hub for the interaction among the clinical sites and other functional work areas.</p><p><strong>External Advisory Committee (EAC)</strong><br>An External Advisory Committee will be established post-award by NIAID to review progress and to provide recommendations to investigators as part of the annual programmatic meeting. The EAC membership will consist of scientific experts in the fields of infant and child health, immunology, and influenza virology. Following establishment, the EAC will meet annually to review the progress of the recipient projects and make recommendations to the PDs/PIs regarding direction of the research program on an ongoing basis and in consultation with NIAID staff.<strong> Note that </strong> <strong>new applicants should not contact, recruit, or name potential EAC members until application review activities are completed. For a renewal application, applicants should provide the names of current and former members but should not recruit or name new members until application review activities are completed.</strong></span></p><p><strong>Annual Programmatic Meetings</strong><br>In the first year of the award, a kick-off meeting will be held to articulate and establish the major roles and functions of the program. Beginning in year 02 of the award and annually thereafter, a program meeting will be held to facilitate collaborations, provide progress reporting, seek new research directions and ideas, and update NIAID. These meetings will be attended by the PD(s)/PI(s), key personnel, EAC members, the NIAID Project Scientist, other NIAID personnel, and other relevant interest holders.</p><p><strong>Opportunity Fund</strong><br>In consultation with NIAID, each recipient will develop and manage an Opportunity Fund that is intended to support research in new or emerging research, promote sharing of resources and expertise, and other collaborative activities consistent with the research objectives of the award. The recipient will be responsible for developing the specific processes necessary for solicitation, review, selection, and implementation of small pilot projects awarded through the Opportunity Fund. These small projects may include for example, collaborative pilot/feasibility projects among recipients, early-stage investigator or trainee research projects, or other activities that further the collaborative objectives and goals among the recipients.</p><p><strong>Applications proposing any of the following topic areas will be considered nonresponsive and will not be reviewed</strong>:</p><ul><li>Applications that are not focused on the effect of repeated exposures to natural infections or vaccinations on the maintenance and evolution of influenza-specific humoral and T cell-mediated immunity in infants and children.</li><li><a href="https://grants.nih.gov/policy/clinical-trials/definition.htm">Clinical trials</a>; however, clinical research and research using samples from human subjects are allowed.</li><li>Studies on HIV, SIV or AIDS.</li><li>Studies using animals or animal models.</li><li>Genome-wide association studies (GWAS).</li><li>Behavioral research.</li></ul>
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<a id='_bookmark261250' 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='_bookmark261251' tabindex='-1' aria-hidden='true'></a><a name="_Section II. Award Information"></a><h2>Section II. Award Information</h2>
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<a id='_bookmark261252' tabindex='-1' aria-hidden='true'></a>Funding Instrument
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<p>Cooperative Agreement: A financial assistance mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this NOFO.</p>
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<div class="col-md-4 datalabel" tabindex="0" data-element-id="261253" data-element-required="true" data-element-has-value="true" data-section-code="AI" data-element-type="LINKED_ELEMENT">
<a id='_bookmark261253' tabindex='-1' aria-hidden='true'></a> Application Types Allowed
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New
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<a id='_bookmark261255' tabindex='-1' aria-hidden='true'></a><p>The <a href="http://grants.nih.gov/grants/guide/url_redirect.htm?id=11116">OER Glossary</a> and the How to Apply Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.</p>
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<p>Not Allowed: Only accepting applications that do not propose clinical trials.</p>
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<a id='_bookmark261257' tabindex='-1' aria-hidden='true'></a><p><a href="https://grants.nih.gov/grants/guide/url_redirect.htm?id=82370">Need help determining whether you are doing a clinical trial?</a></p>
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<a id='_bookmark261258' tabindex='-1' aria-hidden='true'></a>Funds Available and Anticipated Number of Awards
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<p>NIAID intends to commit $9.6 million in FY 2027 to fund 2-4 awards.</p>
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<a id='_bookmark261259' tabindex='-1' aria-hidden='true'></a>Award Budget
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<p>Application budgets are not expected to exceed $3 million in direct costs per year and need to reflect the actual needs of the proposed project.</p>
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<a id='_bookmark261260' tabindex='-1' aria-hidden='true'></a>Award Project Period
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<p>The scope of the proposed project should determine the project period. The maximum project period must be five years. </p>
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<a id='_bookmark261261' tabindex='-1' aria-hidden='true'></a><p>NIH grants policies as described in the <a href="http://grants.nih.gov/grants/guide/url_redirect.htm?id=11120">NIH Grants Policy Statement</a> will apply to the applications submitted and awards made from this NOFO.</p>
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<a id='_bookmark261262' tabindex='-1' aria-hidden='true'></a><a name="_Section III. Eligibility Information"></a><h2>Section III. Eligibility Information</h2>
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<a id='_bookmark261263' tabindex='-1' aria-hidden='true'></a><h4>1. Eligible Applicants</p>
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<a id='_bookmark261264' tabindex='-1' aria-hidden='true'></a>Eligible Organizations
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<p>Higher Education Institutions - Includes all types</p><ul><li>Public/State Controlled Institutions of Higher Education</li><li>Private Institutions of Higher Education</li></ul><p>Nonprofits Other Than Institutions of Higher Education</p><ul><li>Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)</li><li>Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)</li></ul><p>For-Profit Organizations</p><ul><li>Small Businesses</li><li>For-Profit Organizations (Other than Small Businesses)</li></ul><p>Local Governments</p><ul><li>State Governments</li><li>County Governments</li><li>City or Township Governments</li><li>Special District Governments</li><li>Indian/Native American Tribal Governments (Federally Recognized)</li><li>Indian/Native American Tribal Governments (Other than Federally Recognized).</li></ul>
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<a id='_bookmark261265' tabindex='-1' aria-hidden='true'></a><p>Federal Governments</p>
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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='_bookmark261266' tabindex='-1' aria-hidden='true'></a><p>Other</p>
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<li>Independent School Districts</li>
<li>Public Housing Authorities/Indian Housing Authorities</li>
<li>Native American Tribal Organizations (other than Federally recognized tribal governments)</li>
<li>Faith-based or Community-based Organizations</li>
<li>Regional Organizations</li>
<li>Non-domestic (non-U.S.) Entities (Foreign Organizations)</li>
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<a id='_bookmark261268' tabindex='-1' aria-hidden='true'></a><h4>Foreign Organizations/International Collaborations</h4>
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<a id='_bookmark261269' tabindex='-1' aria-hidden='true'></a><p class="Normal">Non-domestic (non-U.S.) Entities (Foreign Organizations) <strong>are </strong>eligible to apply.</p>
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<a id='_bookmark261270' tabindex='-1' aria-hidden='true'></a><p>Non-domestic (non-U.S.) components of U.S. Organizations <strong>are </strong>eligible to apply.</p>
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<a id='_bookmark261271' tabindex='-1' aria-hidden='true'></a><p class="Normal">Foreign components, as <a href="http://grants.nih.gov/grants/guide/url_redirect.htm?id=11118">defined in the NIH Grants Policy Statement</a>, <b>are </b>allowed.</p>
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<a id='_bookmark262147' tabindex='-1' aria-hidden='true'></a><p>NIH will no longer issue awards (i.e., new, renewal, or non-competing continuation) to domestic or foreign entities that involve foreign subawards/subcontracts. All NIH-funded research involving foreign subawards/subcontracts must be submitted in response to a NOFO that is specifically designated for funded international collaborations. This new requirement was effective, May 1, 2025.</p><p>Applications involving foreign subawards/subcontracts submitted in response to this NOFO will be deemed noncompliant and will not be considered for funding. This policy applies to all monetary international collaborations resulting in foreign subawards/subcontracts, however, it does not preclude unfunded international collaborations or <a href="https://grants.nih.gov/grants/policy/nihgps/HTML5/section_1/1.2_definition_of_terms.htm">foreign components</a>, funding for foreign consultants, or procurement of unique equipment or supplies from foreign vendors.</p>
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<a id='_bookmark261272' tabindex='-1' aria-hidden='true'></a>Required R
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