Opportunities for Collaborative Research at the NIH Clinical Center (U01 Clinical Trial Optional)
National Institutes of Health
Funding Amount
Up to $500,000
Deadline
March 6, 2027
332 days left
Grant Type
federal
Overview
Opportunities for Collaborative Research at the NIH Clinical Center (U01 Clinical Trial Optional)
The goal of this program is to support collaborative translational research projects aligned with NIH efforts to enhance the translation of basic biological discoveries into clinical applications that improve health. It encourages high quality science demonstrating the potential to result in understanding an important disease process or lead to new therapeutic interventions, diagnostics, or prevention strategies within the research interests and priorities of the participating NIH Institutes/Centers (ICs).Specifically, the program seeks to broaden and strengthen translational research collaborations between basic and clinical researchers both within and outside NIH to accelerate and enhance translational science by promoting partnerships between NIH intramural investigators (e.g., those conducting research within the labs and clinics of the NIH) and extramural investigators (e.g., those conducting research in labs outside the NIH), and by providing support for extramural investigators to take advantage of the unique research opportunities available at the NIH Clinical Center by conducting clinical research projects in collaboration with NIH intramural investigators.
Details
- Agency: National Institutes of Health
- Department: Department of Health and Human Services
- Opportunity #: PAR-26-116
- Instrument: cooperative_agreement
Eligibility
Refer to Section III. Eligibility Information in the NOFO for additional information on eligibility. Non-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 resulting in foreign subawards/subcontracts, however,
Eligibility
Eligible Applicant Types
How to Apply
PAR-26-116-Full-Announcement.html
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<title>PAR-26-116: Opportunities for Collaborative Research at the NIH Clinical Center (U01 Clinical Trial Optional)</title>
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<div id="page-title" class="heading1" tabindex="0">Department of Health and Human Services</div>
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<a id='_bookmark261213' tabindex='-1' aria-hidden='true'></a><a name="_Part 1. Overview Information"></a><h1>Part 1. Overview Information</h1>
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<a id='_bookmark261214' tabindex='-1' aria-hidden='true'></a>Participating Organization(s)
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<p>National Institutes of Health (<a href="http://www.nih.gov">NIH</a>)</p>
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<a id='_bookmark261216' tabindex='-1' aria-hidden='true'></a>Components of Participating Organizations
</div>
<div class=" col-md-8 datacolumn">
<p>Office of The Director, National Institutes of Health (<a href="https://www.nih.gov/institutes-nih/nih-office-director" target="_blank" rel="noreferrer">OD</a>)
<p>National Eye Institute (<a href="https://www.nei.nih.gov/" target="_blank" rel="noreferrer">NEI</a>)
</p>
<p>National Heart, Lung, and Blood Institute (<a href="https://www.nhlbi.nih.gov/" target="_blank" rel="noreferrer">NHLBI</a>)
</p>
<p>National Institute on Alcohol Abuse and Alcoholism (<a href="https://www.niaaa.nih.gov/" target="_blank" rel="noreferrer">NIAAA</a>)
</p>
<p>National Institute of Allergy and Infectious Diseases (<a href="https://www.niaid.nih.gov/" target="_blank" rel="noreferrer">NIAID</a>)
</p>
<p>National Institute of Arthritis and Musculoskeletal and Skin Diseases (<a href="https://www.niams.nih.gov/" target="_blank" rel="noreferrer">NIAMS</a>)
</p>
<p>Eunice Kennedy Shriver National Institute of Child Health and Human Development (<a href="https://www.nichd.nih.gov/" target="_blank" rel="noreferrer">NICHD</a>)
</p>
<p>National Institute on Deafness and Other Communication Disorders (<a href="https://www.nidcd.nih.gov/" target="_blank" rel="noreferrer">NIDCD</a>)
</p>
<p>National Institute of Dental and Craniofacial Research (<a href="https://www.nidcr.nih.gov/" target="_blank" rel="noreferrer">NIDCR</a>)
</p>
<p>National Institute of Mental Health (<a href="https://www.nimh.nih.gov/index.shtml" target="_blank" rel="noreferrer">NIMH</a>)
</p>
<p>National Institute of Neurological Disorders and
Stroke (<a href="https://www.ninds.nih.gov/" target="_blank" rel="noreferrer">NINDS</a>)
</p>
<p>National Center for Complementary and Integrative Health (<a href="https://nccih.nih.gov/" target="_blank" rel="noreferrer">NCCIH</a>)
</p>
<p>National Cancer Institute (<a href="https://www.cancer.gov/" target="_blank" rel="noreferrer">NCI</a>)
</p>
<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>Office of Research on Women's Health (<a href="https://orwh.od.nih.gov/" target="_blank" rel="noreferrer">ORWH</a>)
</p>
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<a id='_bookmark261218' tabindex='-1' aria-hidden='true'></a>Funding Opportunity Title
</div>
<div class=" col-md-8 datacolumn">
<span class="title">Opportunities for Collaborative Research at the NIH Clinical Center (U01 Clinical Trial Optional)</span>
</div>
</div>
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<a id='_bookmark261219' tabindex='-1' aria-hidden='true'></a>Activity Code
</div>
<div class=" col-md-8 datacolumn">
<p><a href="http://grants.nih.gov/grants/funding/ac_search_results.htm?text_curr=u01&Search.x=0&Search.y=0&Search_Type=Activity">U01</a> Research Project – Cooperative Agreements</p>
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<div class="col-md-4 datalabel" tabindex="0" data-element-id="261220" data-element-required="true" data-element-has-value="true" data-section-code="OI" data-element-type="LINKED_ELEMENT">
<a id='_bookmark261220' tabindex='-1' aria-hidden='true'></a>Announcement Type
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<div class=" col-md-8 datacolumn">
Reissue of
<a href="https://grants.nih.gov/grants/guide/pa-files/PAR-21-343.html" target="_blank" rel="noreferrer">PAR-21-343</a>
<br/>
</div>
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<a id='_bookmark261221' tabindex='-1' aria-hidden='true'></a>Related Notices
</div>
<div class=" col-md-8 datacolumn">
<ul><li>Check for any recent <a href="https://grants.nih.gov/grants/guide/url_redirect.php?id=11163">Notices of NIH Policy Changes</a> that may impact application requirements.</li></ul>
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<a id='_bookmark261222' tabindex='-1' aria-hidden='true'></a>Funding Opportunity Number (FON)
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<div class=" col-md-8 datacolumn">
<span class="noticenum">PAR-26-116</span>
</div>
</div>
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<a id='_bookmark261223' tabindex='-1' aria-hidden='true'></a>Companion Funding Opportunity
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<div class=" col-md-8 datacolumn">
None
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<a id='_bookmark261224' tabindex='-1' aria-hidden='true'></a>Number of Applications
</div>
<div class=" col-md-8 datacolumn">
<p>See <a href="#_3._Additional_Information">Section III. 3. Additional Information on Eligibility</a>.</p>
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<a id='_bookmark261225' tabindex='-1' aria-hidden='true'></a>Assistance Listing Number(s)
</div>
<div class=" col-md-8 datacolumn">
93.313, 93.242, 93.867, 93.394, 93.395, 93.855, 93.121, 93.853, 93.837, 93.838, 93.839, 93.840, 93.233, 93.273, 93.846, 93.213, 93.173, 93.865
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<a id='_bookmark261226' tabindex='-1' aria-hidden='true'></a>Funding Opportunity Purpose
</div>
<div class=" col-md-8 datacolumn">
<p>The goal of this program is to support collaborative translational research projects aligned with NIH efforts to enhance the translation of basic biological discoveries into clinical applications that improve health. It encourages high quality science demonstrating the potential to result in understanding an important disease process or lead to new therapeutic interventions, diagnostics, or prevention strategies within the research interests and priorities of the participating NIH Institutes/Centers (ICs).</p><p>Specifically, the program seeks to broaden and strengthen patient-centric translational research collaborations between basic and clinical researchers both within and outside NIH to accelerate and enhance translational science by promoting partnerships between NIH intramural investigators (e.g., those conducting research within the labs and clinics of the NIH) and extramural investigators (e.g., those conducting research in labs outside the NIH), and by providing support for extramural investigators to take advantage of the unique research opportunities available at the NIH Clinical Center by conducting clinical research projects in collaboration with NIH intramural investigators.</p><p>In order to be eligible for this program, the application must include at least one intramural scientist as a co-Program Director/Principal Investigator (co-PD/PI), and at least some of the clinical research must be conducted at the NIH Clinical Center. Through this collaboration, external researchers may gain access to the NIH Clinical Center and leverage the wide variety of Clinical Center resources, expertise, and infrastructure available to test promising laboratory-and animal-based discoveries with potential for advancing disease diagnosis, treatment and prevention. The special environment of the Clinical Center can support studies that may not be readily supported elsewhere. This may include collaborations that propose targeted increases in new patients enrolled in protocols at the Clinical Center. For this initiative, patients must be seen at the NIH Clinical Center. Projects that take only minimal advantage of Clinical Center resources, such as projects only utilizing banked samples or data, will not be considered for funding.</p>
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<a id='_bookmark261228' tabindex='-1' aria-hidden='true'></a>Funding Opportunity Goal(s)
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<div class=" col-md-8 datacolumn">
<p>The goals of the agency are:</p><ul><li>to foster fundamental creative discoveries, innovative research strategies, and their applications as a basis for ultimately protecting and improving health;</li><li>to expand the knowledge base in medical and associated sciences in order to enhance the Nation's economic well-being and ensure a continued high return on the public investment in research</li></ul>
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<a id='_bookmark261229' tabindex='-1' aria-hidden='true'></a><a name="_Key Dates"></a><h2>Key Dates</h2>
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<a id='_bookmark261230' tabindex='-1' aria-hidden='true'></a>Posted Date
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<a id='_bookmark261231' tabindex='-1' aria-hidden='true'></a>Open Date (Earliest Submission Date)
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January 05, 2026
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The following table includes NIH <a href="https://grants.nih.gov/grants/how-to-apply-application-guide/due-dates-and-submission-policies/due-dates.htm" target="_blank" rel="noreferrer">standard due dates</a> marked with an asterisk.
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<th scope="col" colspan="3" style="border:2px solid #bcbcbc;" class="text-center">Application Due Dates</th>
<th scope="col" colspan="3" style="border:2px solid #bcbcbc;" class="text-center">Review and Award Cycles</th>
</tr>
<tr>
<th scope="col" style="width:16.66%;border-left:2px solid #bcbcbc;" class="text-center">New</th>
<th scope="col" style="width:16.66%" class="text-center">Renewal / Resubmission / Revision (as allowed)</th>
<th scope="col" style="width:16.66%;border-right:2px solid #bcbcbc;" class="text-center">AIDS - New/Renewal/Resubmission/Revision, as allowed</th>
<th scope="col" style="width:16.66%" class="text-center">Scientific Merit Review</th>
<th scope="col" style="width:16.66%" class="text-center">Advisory Council Review</th>
<th scope="col" style="width:16.66%;border-right:2px solid #bcbcbc;" class="text-center">Earliest Start Date</th>
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<td>
February 05, 2026 *
</td>
<td>
March 05, 2026 *
</td>
<td>
Not Applicable
</td>
<td>July 2026</td>
<td> October 2026
</td>
<td>December 2026</td>
</tr>
<tr>
<td>
February 05, 2027 *
</td>
<td>
March 05, 2027 *
</td>
<td>
Not Applicable
</td>
<td>July 2027</td>
<td> October 2027
</td>
<td>December 2027</td>
</tr>
</tbody>
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<a id='_bookmark261235' tabindex='-1' aria-hidden='true'></a><p>All applications are due by 5:00 PM local time of applicant organization. </p>
<p>Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.</p>
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<a id='_bookmark261241' tabindex='-1' aria-hidden='true'></a>Due Dates for E.O. 12372
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<p>Not Applicable</p>
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<a id='_bookmark261242' tabindex='-1' aria-hidden='true'></a>Expiration Date
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March 06, 2027
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<a id='_bookmark261243' tabindex='-1' aria-hidden='true'></a>Required Application Instructions
</div>
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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>
</div>
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<a id='_bookmark262235' tabindex='-1' aria-hidden='true'></a><p style="margin-left:0in;">There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You <strong>must</strong> use one of these submission options to access the application forms for this opportunity.</p><ol><li>Use the <a href="https://public.era.nih.gov/assist/landing.era?tabId=0819b5fc-46b7-4f02-b6b7-127e5a4e19fa">NIH ASSIST system</a> to prepare, submit and track your application online.</li><li>Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and <a href="https://public.era.nih.gov/commons/">eRA Commons</a> to track your application. Check with your institutional officials regarding availability.</li><li>Use <a href="https://grants.gov/search-grants?oppStatuses=closed|archived|posted|forecasted&fon=PA-25-301">Grants.gov</a> Workspace to prepare and submit your application and <a href="http://public.era.nih.gov/commons/">eRA Commons</a> to track your application.</li></ol>
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<div class="heading1" tabindex="0">Table of Contents</div>
<div class="toc-link"><a href="#_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><p>The goal of this Notice of Funding Opportunity (NOFO) is to support collaborative, patient-centric translational research projects aligned with NIH efforts to enhance the translation of basic biological discoveries into clinical applications that improve health. This opportunity is specifically to promote partnerships between NIH intramural investigators (e.g., those conducting research within the labs and clinics of the NIH) and extramural investigators (e.g., those conducting research in labs and clinics outside of the NIH). It will provide support for extramural investigators to take advantage <a href="http://www.cc.nih.gov/translational-research-resources/resources.html">of the unique research opportunities available at the NIH Clinical Center (</a><a href="https://ocreco.od.nih.gov/new_u01/new_u01.html">https://ocreco.od.nih.gov/new_u01/new_u01.html</a>) by conducting research projects in collaboration with NIH intramural investigators. For this initiative, while some study participants may be seen at extramural sites, other study subjects must be seen at the NIH Clinical Center. Projects that take only minimal advantage of Clinical Center resources, such as projects only utilizing banked specimens or data, would not be considered for funding.</p><p>While translating basic research into clinical practice is increasingly difficult, time-consuming, and expensive, translational research is crucially important in converting basic scientific discoveries into new diagnostics and therapies for patients. As such, this NOFO intends to broaden and strengthen translational research collaborations between basic and clinical researchers both within and outside NIH to accelerate and enhance translational science. All teams must have at least one intramural and one extramural investigator.</p><p>This program will provide access for external researchers to the NIH Clinical Center and will leverage the wide variety of Clinical Center resources, expertise, and infrastructure available to test promising laboratory- and animal-based discoveries with potential implications for disease diagnosis, treatment and prevention in human subjects. The NIH Clinical Center is a hospital exclusively dedicated to clinical research, thus research is the culture and research studies are routine. Its mission includes the support of clinical studies that are considered intellectually challenging and risky but with the potential of high reward with new breakthroughs in medicine. The special environment of the Clinical Center supports studies that may not be readily supported elsewhere. This includes collaborations that propose targeted increases in new patients enrolled in protocols at the Clinical Center.</p><p>Examples of the special resources of the Clinical Center include:</p><ul><li>Large cohorts of patients, including studies of >500 rare diseases;</li><li>The manufacturing and use of newly designed PET ligands for imaging studies;</li><li>The availability of blood products for special research studies;</li><li>Collaborative opportunities on clinical protocols (http://clinicalstudies.info.nih.gov/) on unique pharmaceutical agents and/or other modes of therapy, or extraordinarily rare diseases with investigators who are known experts;</li><li>A robust training curriculum in clinical research;</li><li>The ability to support long-term clinical studies at minimal cost to patients and their families.</li><li>On-campus amenities (e.g., <a href="http://clinicalcenter.nih.gov/familylodge/index.shtml">Family Lodge</a> and <a href="https://childrensinn.org/">Children's Inn</a>) to assist patients and families in supportive, home-like environments as they leave their own homes to participate in clinical research; and</li><li>A number of other resources</li></ul><p>For entry to the program, projects must have a collaborating Investigator in the NIH Intramural Program. As a collaborative partner, the intramural investigator will be actively involved in the planning and execution of the research project. Applicants are strongly encouraged to contact the appropriate Scientific/Research contact listed in Section VII if the collaborating intramural investigator is from an NIH Institute or Center that is different from the Institute or Center expected to receive the X02/U01 applications. Additional information is available on the "Frequently Asked Questions" website for the program (<a href="https://ocreco.od.nih.gov/new_u01/faqs.html">https://ocreco.od.nih.gov/new_u01/faqs.html</a>).</p><p>Applications for this program will be submitted by the extramural institution with the participation of the intramural investigator(s) integrated into the application as described in the Collaboration Plan, and with the budget requirements for the NIH Clinical Center (if any) and for the intramural investigators included in the Budget form of the application. Funded projects will include an award to the applicant organization which will exclude any funds requested to support the participation of the Clinical Center. Support for intramural participation will first be determined, then provided if applicable by a budget allocation within the NIH. Annual progress reports will be prepared and submitted by the extramural institutions, with the participation and input of the intramural investigator(s) and should include the project findings, publications, impact of the project, a description of which Clinical Center unique resources were utilized and any new intramural- extramural partnerships that developed.</p><p><strong>NIH Clinical Center Costs</strong></p><p>No Clinical Center costs will be charged to the grant except for the cost of all drugs that are the subject of the study, including controls (standard of care drugs will be free). Resources required need to be determined before the research protocol can be approved by the Clinical Center. The collaborating intramural investigator is responsible for coordination with the Clinical Center to assure that any Clinical Center related costs are clearly identified and documented in a timely manner. If there are such Clinical Center costs, the (extramural) applicant will enter this amount as a "subaward" budget in the budget section of the application, using "NIH Clinical Center Costs" as the descriptor. More detailed information about Clinical Center costs may be found at <a href="https://ocreco.od.nih.gov/new_u01/budget.html">https://ocreco.od.nih.gov/new_u01/budget.html</a>.</p><p>F&A (Indirect) Costs: Applicant organizations are reminded that Facilities and Administrative (F&A) or "indirect costs" are allowable for only the allowable extramural costs of the project. F&A will not be paid for any NIH Clinical Center services or intramural investigator costs.</p><p>Budget Justification: Detailed information about intramural investigator costs and any NIH Clinical Center costs should be included in the narrative "Budget Justification" section.</p><p><strong>Additional Guidance on Budget Preparation</strong></p><p>The budget requests for this NOFO are more complex and will require more coordination than those of other programs. Therefore, extramural investigators are encouraged to begin discussions about logistics and budget issues with their intramural collaborators and with NIH staff in the early phases of application preparation. Determination of any Clinical Center costs will require coordination between the intramural investigator and the Clinical Center Office of the Chief Financial Officer, and sufficient time should be allowed for this process. Specific questions about budget preparation may be addressed to the Agency Contacts listed in Section VII or to <a href="mailto:ClinicalCtrPartner@mail.nih.gov">ClinicalCtrPartner@mail.nih.gov</a>.</p><p><strong>Letters of Support</strong><br>Applications must include Letters of Support (LOS) from the NIH Clinical Center and one of the participating NIH Institutes/Centers.</p><p>Requests for Letters of Support should be made through the Request for LOS process. Instructions for submitting requests can be found at <a href="https://ocreco.od.nih.gov/new_u01/letters_of_support.html.">https://ocreco.od.nih.gov/new_u01/letters_of_support.html.</a> </p><p>Applicants must send requests by October 31st to:</p><p>David J. Eckstein, PhD<br>Program Director, Strategic Partnerships<br>NIH Office of Clinical Research<br>Telephone: 301-496-4121<br>Email: <a href="mailto:ClinicalCtrPartner@mail.nih.gov">ClinicalCtrPartner@mail.nih.gov</a></p><p><strong>IMPORTANT: </strong>Applicants are strongly encouraged to consult with the Scientific/Research Contacts for the area of science for which they are planning to develop an application. Early contact provides an opportunity for IC staff to discuss the program scope and goals, and to provide information and guidance. Other aspects of an application that are unique to this program including collaboration with Intramural Investigators may also be discussed.</p><p>For a more complete listing of resources in these research areas at the NIH Clinical Center and for assistance in how to apply, please refer to the website for the program at <a href="https://ocreco.od.nih.gov/new_u01/new_u01.html">https://ocreco.od.nih.gov/new_u01/new_u01.html</a>. </p><p><strong>Non-Responsive Applications:</strong></p><p>Applications will be considered non-responsive if they take only minimal advantage of Clinical Center resources, such as utilizing only banked samples or data.</p>
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<a id='_bookmark261249' tabindex='-1' aria-hidden='true'></a><p>Investigators proposing NIH-defined clinical trials may refer to the <a href="https://researchmethodsresources.nih.gov/">Research Methods Resources</a> website for information about developing statistical methods and study designs.</p>
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<a id='_bookmark261250' tabindex='-1' aria-hidden='true'></a><p>See <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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<a id='_bookmark261253' tabindex='-1' aria-hidden='true'></a> Application Types Allowed
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New
<br>
Renewal
<br>
Resubmission
<br>
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<div class="col-md-push-4 col-md-8 datacolumn">
<a id='_bookmark261255' tabindex='-1' aria-hidden='true'></a><p>The <a href="http://grants.nih.gov/grants/guide/url_redirect.htm?id=11116">OER Glossary</a> and the How to Apply Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.</p>
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<a id='_bookmark261256' 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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<div class="col-md-push-4 col-md-8 datacolumn">
<a id='_bookmark261257' tabindex='-1' aria-hidden='true'></a><p><a href="https://grants.nih.gov/grants/guide/url_redirect.htm?id=82370">Need help determining whether you are doing a clinical trial?</a></p>
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<a id='_bookmark261258' tabindex='-1' aria-hidden='true'></a>Funds Available and Anticipated Number of Awards
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<p class="Normal">The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.</p>
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<a id='_bookmark261259' tabindex='-1' aria-hidden='true'></a>Award Budget
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<p class="Normal">Application budgets need to reflect the actual needs of the proposed project. The maximum amount available per application is $500,000 direct costs per year; this amount includes extramural recipient costs, Clinical Center costs and intramural investigator's costs attributed to the proposed research project. The total of all three types of cost must not exceed $500,000 (direct costs) per year.</p><p class="Normal">The NIH Clinical Center costs and intramural investigator's costs will not be included in the award issued to the recipient.</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. For projects that do not need a planning year, the maximum project period is 4 years. If the project needs to include a planning year as part of the research plan, a fifth year can be proposed (grant year 1) at a reduced budget level. </p>
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<a id='_bookmark261261' tabindex='-1' aria-hidden='true'></a><p>NIH grants policies as described in the <a href="http://grants.nih.gov/grants/guide/url_redirect.htm?id=11120">NIH Grants Policy Statement</a> will apply to the applications submitted and awards made from this NOFO.</p>
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<a id='_bookmark261262' tabindex='-1' aria-hidden='true'></a><a name="_Section III. Eligibility Information"></a><h2>Section III. Eligibility Information</h2>
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<a id='_bookmark261263' tabindex='-1' aria-hidden='true'></a><h4>1. Eligible Applicants</p>
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<a id='_bookmark261264' tabindex='-1' aria-hidden='true'></a>Eligible Organizations
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<p>Higher Education Institutions - Includes all types</p><ul><li>Public/State Controlled Institutions of Higher Education</li><li>Private Institutions of Higher Education</li></ul><p>Nonprofits Other Than Institutions of Higher Education</p><ul><li>Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)</li><li>Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)</li></ul><p>For-Profit Organizations</p><ul><li>Small Businesses</li><li>For-Profit Organizations (Other than Small Businesses)</li></ul><p>Local Governments</p><ul><li>State Governments</li><li>County Governments</li><li>City or Township Governments</li><li>Special District Governments</li><li>Indian/Native American Tribal Governments (Federally Recognized)</li><li>Indian/Native American Tribal Governments (Other than Federally Recognized).</li></ul>
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<a id='_bookmark261265' tabindex='-1' aria-hidden='true'></a><p>Federal Governments</p>
<ul>
<li>Eligible Agencies of the Federal Government</li>
<li>U.S. Territory or Possession</li>
</ul>
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<a id='_bookmark261266' tabindex='-1' aria-hidden='true'></a><p>Other</p>
<ul>
<li>Independent School Districts</li>
<li>Public Housing Authorities/Indian Housing Authorities</li>
<li>Native American Tribal Organizations (other than Federally recognized tribal governments)</li>
<li>Faith-based or Community-based Organizations</li>
<li>Regional Organizations</li>
<li>Non-domestic (non-U.S.) Entities (Foreign Organizations)</li>
</ul>
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<a id='_bookmark261268' tabindex='-1' aria-hidden='true'></a><h4>Foreign Organizations/International Collaborations</h4>
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<a id='_bookmark261269' tabindex='-1' aria-hidden='true'></a><p class="Normal">Non-domestic (non-U.S.) Entities (Foreign Organizations) <strong>are </strong>eligible to apply.</p>
</div>
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<a id='_bookmark261270' tabindex='-1' aria-hidden='true'></a><p>Non-domestic (non-U.S.) components of U.S. Organizations <strong>are </strong>eligible to apply.</p>
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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 Registrations
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<p><strong>Applicant Organizations</strong></p>
<p>Applicant organizations must complete and maintain the following registrations as described in the How to Apply- Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference the <a href="http://grants.nih.gov/grants/guide/url_redirect.htm?id=82423">NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications</a> for additional information.</p>
<ul>
<li><a href="https://grants.nih.gov/grants/guide/url_redirect.htm?id=82390">System for Award Management (SAM) –</a> Applicants must complete and maintain an active registration, <strong>which requires renewal at least annually</strong>. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
<ul>
<li><a href="http://grants.nih.gov/grants/guide/url_redirect.htm?id=11176">NATO Commercial and Government Entity (NCAGE) Code</a> – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.</li>
<li>Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.</li>
</ul>
</li>
<li><a href="https://grants.nih.gov/grants/guide/url_redirect.htm?id=11123">e
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