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<TITLE>Expired PA-23-134: NIH Administrative Supplements to Recover Losses due to Hurricanes Fiona and Ian Under the Consolidated Appropriations Act, 2023 (Admin Supp Clinical Trial Optional)</TITLE>
<META NAME="description" CONTENT="NIH Funding Opportunities and Notices in the NIH Guide for Grants and Contracts: NIH Administrative Supplements to Recover Losses due to Hurricanes Fiona and Ian Under the Consolidated Appropriations Act, 2023 (Admin Supp Clinical Trial Optional) PA-23-134. NIH">
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<div class="noticeBar">This notice has expired. Check the <a href="https://grants.nih.gov/funding/searchguide/">NIH Guide</a> for active opportunities and notices.</div>
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<p id="watermark_text">EXPIRED</p>
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<div class="heading1"><a name="_Toc258852634"></a>Department of Health and Human Services</div>
<div class="heading1"><a name="_Toc258873264"></a><a name="_Part_1._Overview"></a>Part 1. Overview Information</div>
<table class=regulartextTable border=0.0pt cellspacing=0 cellpadding=0 width="100%">
<tr style="padding:7px;">
<td width="27%" valign=top>
<div class="heading4">Participating Organization(s)</div>
</td>
<td width="72%" valign=top>
<p class=regulartext>National Institutes of Health (<a href="http://www.nih.gov">NIH</a>)</p>
</td>
</tr>
<tr style="padding:7px;">
<td width="27%" valign=top>
<div class="heading4"><a name="_Components_of_Participating"></a>Components
of Participating Organizations</div>
</td>
<td width="72%" valign=top>
<p class=regulartext>National Cancer Institute (<a
href="http://www.nci.nih.gov/">NCI</a>)</p>
<p class=regulartext>National Eye Institute (<a href="http://www.nei.nih.gov">NEI</a>)</p>
<p class=regulartext>National Heart, Lung, and Blood Institute (<a href="http://www.nhlbi.nih.gov">NHLBI</a>)</p>
<p class=regulartext>National Human Genome Research Institute (<a href="http://www.nhgri.nih.gov/">NHGRI</a>)</p>
<p class=regulartext>National Institute on Aging (<a href="http://www.nia.nih.gov">NIA</a>)</p>
<p class=regulartext>National Institute on Alcohol Abuse and Alcoholism (<a
href="http://www.niaaa.nih.gov">NIAAA</a>)</p>
<p class=regulartext>National Institute of Allergy and Infectious Diseases (<a
href="http://www.niaid.nih.gov">NIAID</a>)</p>
<p class=regulartext>National Institute of Arthritis and Musculoskeletal and Skin Diseases (<a
href="http://www.niams.nih.gov">NIAMS</a>)</p>
<p class=regulartext>National Institute of Biomedical Imaging and Bioengineering (<a
href="http://www.nibib.nih.gov">NIBIB</a>)</p>
<p class=regulartext><i>Eunice Kennedy Shriver</i> National Institute of Child Health and Human
Development (<a href="http://www.nichd.nih.gov">NICHD</a>)</p>
<p class=regulartext>National Institute on Deafness and Other Communication Disorders (<a
href="http://www.nidcd.nih.gov">NIDCD</a>)</p>
<p class=regulartext>National Institute of Dental and Craniofacial Research (<a
href="http://www.nidcr.nih.gov">NIDCR</a>)</p>
<p class=regulartext>National Institute of Diabetes and Digestive and Kidney Diseases (<a
href="http://www.niddk.nih.gov">NIDDK</a>)</p>
<p class=regulartext>National Institute on Drug Abuse (<a href="http://www.nida.nih.gov">NIDA</a>)</p>
<p class=regulartext>National Institute of Environmental Health Sciences (<a
href="http://www.niehs.nih.gov">NIEHS</a>)</p>
<p class=regulartext>National Institute of General Medical Sciences (<a
href="http://www.nigms.nih.gov">NIGMS</a>)</p>
<p class=regulartext>National Institute of Mental Health (<a href="http://www.nimh.nih.gov">NIMH</a>)</p>
<p class=regulartext>National Institute of Neurological Disorders and Stroke (<a
href="http://www.ninds.nih.gov">NINDS</a>)</p>
<p class=regulartext>National Institute of Nursing Research (<a href="http://www.ninr.nih.gov">NINR</a>)</p>
<p class=regulartext>National Institute on Minority Health and Health Disparities (<a
href="http://www.nimhd.nih.gov/">NIMHD</a>)National Library of Medicine (<a href="http://www.nlm.nih.gov">NLM</a>)</p>
<p class=regulartext>Fogarty International Center (<a href="http://www.fic.nih.gov">FIC</a>)National Center for Complementary and Integrative Health (<a
href="http://www.nccam.nih.gov">NCCIH</a>)</p>
<p class=regulartext>National Center for Advancing Translational Sciences (<a
href="http://ncats.nih.gov/">NCATS</a>) </p>
<p class=regulartext>Division of Program Coordination, Planning and Strategic
Initiatives, Office of Research Infrastructure Programs (<a
href="http://dpcpsi.nih.gov/orip/index.aspx">ORIP</a>)</p>
<p class=regulartext>Office of Strategic Coordination (<a href="http://commonfund.nih.gov/">Common
Fund</a>)</p>
<p class=regulartext>All applications to this notice of funding opportunity should
fall within the mission of the Institutes/Centers listed above. The following
NIH Offices may co-fund applications assigned to those Institutes/Centers.</p>
<p class=regulartext>Division of Program
Coordination, Planning and Strategic Initiatives, Office of Disease
Prevention (<a href="http://prevention.nih.gov/default.aspx">ODP</a>)</p>
<p class=regulartext>Office of Behavioral and Social Sciences Research (<a
href="http://obssr.od.nih.gov">OBSSR</a>)</p>
<p class=regulartext>Office of Dietary Supplements (<a
href="http://dietary-supplements.info.nih.gov">ODS</a>)</p>
<p class=regulartext>Office of Research on Women&rsquo;s Health (<a href="http://orwh.od.nih.gov">ORWH</a>)</p>
</td>
</tr>
<tr style="padding:7px;">
<td width="27%" valign=top>
<div class="heading4">Funding Opportunity Title</div>
</td>
<td width="72%" valign=top>
<p class=MsoTitle>NIH Administrative Supplements to Recover
Losses due to Hurricanes Fiona and Ian Under the Consolidated Appropriations
Act, 2023 (Admin Supp Clinical Trial Optional)</p>
</td>
</tr>
<tr style="padding:7px;">
<td width="27%" valign=top>
<div class="heading4">Activity Code</div>
</td>
<td width="72%" valign=top>
<p class=regulartext>Administrative Supplement</p>
<p class=regulartext>Additional funds may be awarded as supplements to parent
awards for all activity codes. </p>
</td>
</tr>
<tr style="padding:7px;">
<td width="27%" valign=top>
<div class="heading4">Announcement Type</div>
</td>
<td width="72%" valign=top>
<p class=regulartext>New</p>
</td>
</tr>
<tr style="padding:7px;">
<td width="27%" valign=top>
<div class="heading4">Related Notices</div>
</td>
<td width="72%" valign=top>
<p class=regulartext><a
href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-20-128.html">NOT-OD-20-128</a>
June 30, 2020- Notice of Requirement for Electronic Submission of all
Administrative Supplements </p>
<p class=regulartext><a
href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-22-195.html">NOT-OD-22-195</a>
New NIH "FORMS-H" Grant Application Forms and Instructions Coming
for Due Dates on or after January 25, 2023</p>
</td>
</tr>
<tr style="padding:7px;">
<td width="27%" valign=top>
<div class="heading4">Notice of Funding Opportunity (NOFO) Number</div>
</td>
<td width="72%" valign=top>
<p class=MsoTitle>PA-23-134</p>
</td>
</tr>
<tr style="padding:7px;">
<td width="27%" valign=top>
<div class="heading4">Companion Notice of Funding
Opportunity</div>
</td>
<td width="72%" valign=top>
<p class=regulartext>None</p>
</td>
</tr>
<tr style="padding:7px;">
<td width="27%" valign=top>
<div class="heading4"><a name="_Number_of_Applications"></a>Number of Applications</div>
</td>
<td width="72%" valign=top>
<p class=regulartext>See <a href="#_3._Additional_Information">Section III. 3.
Additional Information on Eligibility</a>. </p>
</td>
</tr>
<tr style="padding:7px;">
<td width="27%" valign=top>
<div class="heading4">Assistance Listing Number(s)<sub> </sub></div>
</td>
<td width="72%" valign=top>
<p class=regulartext>93.661 </p>
</td>
</tr>
<tr style="padding:7px;">
<td width="27%" valign=top>
<div class="heading4">Funding Opportunity Purpose</div>
</td>
<td width="72%" valign=top>
<p class=regulartext>The purpose of this funding opportunity is for
investigators and institutions impacted by Hurricanes Fiona and Ian with active
NIH grants to request: </p>
<p class=P_SingleIndent>1) a 24-month extension of the current budget
period, with 12-months of funding at the same funding level as the current
year of the grant and/or </p>
<p class=P_SingleIndent>2) a one-time administrative supplement of up to
$150,000 in direct costs (excluding consortium facilities and administrative
costs) to replace lost and/or damaged research resources; and/or</p>
<p class=P_SingleIndent>3) up to $250,000 to replace a single item of
equipment so long as that request is accompanied by well-documented support
for the need to replace that item of equipment; and/or </p>
<p class=P_SingleIndent>4) minor alternation and renovation to research
facilities up to $500,000. </p>
<p class=P_SingleIndent>Supplement requests will be routed to the
appropriate NIH Institutes and Centers for consideration. </p>
<p class=P_SingleIndent> </p>
<p class=regulartext>The number of awards issued will depend on the number of
applicants received and funneled through the review process. </p>
<p class=regulartext>Benefits of this opportunity are restricted to applicants
located in a county or parish where a major disaster has been declared under
the Stafford Act as a result of Hurricanes Fiona and Ian.</p>
<p class=regulartext>Grants at NIH-supported institutions impacted by
Hurricanes Fiona and Ian will be eligible for both the funded extension
and/or administrative supplements. If a grant has relocated or relocates
prior to the award of the funded extension, the funded extension may be
withdrawn.</p>
<p class=regulartext>Applications submitted in response to this announcement
will be considered for funding only with funds appropriated from the
Consolidated Appropriations Act, 2023 (Public Law 117-328). This opportunity
does not preclude additional requests for administrative supplements on other
NIH grant programs or for these mechanisms. Institutes and Centers will still
consider such requests on a case-by-case basis.</p>
<p class=regulartext>These funds cannot duplicate nor overlap with reimbursement
provided by FEMA, under a contract for insurance, or by self-insurance.
Self-insurance is a formal plan, pursuant to law or regulation, in which
amounts are set aside in a fund to cover losses of specified types and
amounts, typically by a commercial insurance company. Appropriated funds are
precluded from expenses that are or can be reimbursed by the formal
self-insurance plan. </p>
<p class=regulartext>This opportunity applies to awards active at the time of
the hurricanes. </p>
</td>
</tr>
</table>
<div class="heading2" style="clear:both;">Key Dates</div>
<table class=regulartextTable border=1 cellspacing=0 cellpadding=0 width="100%">
<div class="row">
<div class="col-md-4 datalabel">Posted Date</div>
<div class="col-md-8 datacolumn"><p class=regulartext>March 17, 2023</p></div>
</div><!--end row-->
<div class="row">
<div class="col-md-4 datalabel">Open Date (Earliest Submission Date)</div>
<div class="col-md-8 datacolumn"><p class=regulartext>March 17, 2023</p></div>
</div><!--end row-->
<div class="row">
<div class="col-md-4 datalabel">Letter of Intent Due Date(s)</div>
<div class="col-md-8 datacolumn"><p class=regulartext>Not Applicable</p></div>
</div><!--end row-->
<div class="row">
<div class="col-md-4 datalabel">Application Due Date(s)</div>
<div class="col-md-8 datacolumn"><p class=regulartext>Applications will be accepted on a rolling basis,
beginning March 17, 2023 </p>
<p class=regulartext>Applicants are encouraged to apply early to allow adequate
time to make any corrections to errors found in the application during the
submission process by the due date.</p></div>
</div><!--end row-->
<div class="row">
<div class="col-md-4 datalabel">AIDS Application Due Date(s)</div>
<div class="col-md-8 datacolumn"><p class=regulartext>Not Applicable</p></div>
</div><!--end row-->
<div class="row">
<div class="col-md-4 datalabel">Scientific Merit Review </div>
<div class="col-md-8 datacolumn"><p class=regulartext>Not Applicable</p></div>
</div><!--end row-->
<div class="row">
<div class="col-md-4 datalabel">Advisory Council Review</div>
<div class="col-md-8 datacolumn"><p class=regulartext>Not Applicable</p></div>
</div><!--end row-->
<div class="row">
<div class="col-md-4 datalabel">Earliest Start Date</div>
<div class="col-md-8 datacolumn"><p class=regulartext>Not Applicable</p></div>
</div><!--end row-->
<div class="row">
<div class="col-md-4 datalabel">Expiration Date</div>
<div class="col-md-8 datacolumn"><p class=regulartext>September 30, 2023 </p></div>
</div><!--end row-->
<div class="row">
<div class="col-md-4 datalabel">Due Dates for E.O. 12372 </div>
<div class="col-md-8 datacolumn"><p class=regulartext>Not Applicable</p></div>
</div><!--end row-->
</table>
<div class="heading4"><a name="_Required_Application_Instructions"></a>Required
Application Instructions</div>
<p class=regulartext>It is critical that applicants follow the instructions in
the Application Guide (<a
href="https://grants.nih.gov/grants/guide/url_redirect.php?id=82400">SF424
(R&R) Application Guide</a>, as
appropriate) except where instructed to do otherwise (in this NOFO or in a Notice
from the <a href="//grants.nih.gov/grants/guide/url_redirect.php?id=11164"><i>NIH
Guide for Grants and Contracts</i></a>). 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 <a
href="#_Section_IV._Application_1">Section IV</a>. When the program-specific instructions
deviate from those in the Application Guide, follow the program-specific
instructions. <b>Applications that do not comply with these instructions may
be delayed or not accepted for review.</b></p>
<br>
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<div class="heading1">Table of Contents</div>
<p class=regulartext><a href="#_Part_1._Overview">Part 1. Overview Information</a><br>
<a href="#_Part_2._Full">Part 2. Full Text of the Announcement</a></p>
<p class=P_SingleIndent><span class=P_SingleIndent><a href="#_Section_I._Funding">Section I. Notice of Funding
Opportunity Description</a></span><br>
<span class=P_SingleIndent><a href="#_Section_II._Award_1">Section II. Award Information</a></span><br>
<span class=P_SingleIndent><a href="#_Section_III._Eligibility">Section III. Eligibility Information</a></span><br>
<span class=P_SingleIndent><a href="#_Section_IV._Application_1">Section IV. Application and Submission Information</a></span><br>
<span class=P_SingleIndent><a href="#_Section_V._Application">Section V. Application Review Information</a></span><br>
<span class=P_SingleIndent><a href="#_Section_VI._Award">Section VI. Award Administration Information</a></span><br>
<span class=P_SingleIndent><a href="#_Section_VII._Agency">Section VII. Agency Contacts</a></span><br>
<span class=P_SingleIndent><a href="#_Section_VIII._Other">Section VIII. Other Information</a></span></p>
<div class="heading1"><a name="_Toc258852635"></a><a name="_Toc258873265"></a><a
name="_Part_2._Full"></a>Part 2. Full Text of Announcement</div>
<div class="heading2"><a name=IFundOppDesc></a><a
name="_Toc258852636"></a><a name="_Toc258873266"></a><a
name="_Section_I._Funding"></a>Section I. Notice of Funding Opportunity Description</div>
<p class=regulartext><a name="_Toc258873267"></a><a name="_Section_II._Award"></a> </p>
<p class=regulartext>Applications submitted in response to this announcement will
be considered for funding only with funds appropriated from the Consolidated
Appropriations Act, 2023 (Public Law 117-328). </p>
<p class=regulartext>This funding opportunity is for those investigators and
institutions impacted by Hurricanes Fiona and Ian and with NIH grants active at
the time of the storms. Benefits of this opportunity are restricted to applicants
located in a county or parish where a major disaster has been declared under
the Stafford Act as a result of Hurricanes Fiona and Ian.</p>
<p class=regulartext>Two options are available: </p>
<p class=regulartext>1) Funded Extension: Recipients may request a funded
extension at the same funding level as the current year of the grant. The
active grant can have multiple future years still committed, e.g., it need not
be in the final year. For those approved for funding, the extension will be
funded as a 24-month extension of the current budget period; however, the
funding provided will be equivalent to 12 months of support based on the
funding level of the current budget period. </p>
<p class=regulartext>2) One-time Administrative Supplements: Recipients may
request </p>
<p class=P_SingleIndent>a) up to $150,000 in direct costs (excluding
consortium F&A costs) to replace lost and/or damaged research resources
such as small pieces of equipment or their repair, supplies, reagents, animals,
etc.; and/or</p>
<p class=P_SingleIndent>b) up to $250,000 to replace a single item of
equipment so long as that request is accompanied by well-documented support for
the need to replace that item of equipment; and/or </p>
<p class=P_SingleIndent>c) minor alternation and renovation (A&R) to
research facilities up to $500,000. </p>
<p class=regulartext>Excluded from the one-time supplement options are salaries,
training costs, travel and recurring supplies (only replacement supplies can be
requested).</p>
<p class=regulartext>Grants at NIH-supported institutions impacted by Hurricanes
Fiona and Ian will be eligible for the funded extension option and/or the
administrative supplement options. If a grant has relocated or relocates prior
to the award of the additional support, the additional support may be
withdrawn.</p>
<p class=regulartext>This funding opportunity includes training and
training-related programs at otherwise eligible institutions. Such programs
include individual research career development awards (Ks), individual
fellowships (Fs), institutional training and scientist development grants (Ts,
Ds, K12s/KL2) and Education grants (R25s). Since the options available for
these programs are very program-specific, contact the Program Official Contact
identified in your Notice of Award before considering submitting an
administrative supplement request. In all cases involving training and
training-related programs, as part of any supplement request a justification
must address how the training and/or educational plan has been disrupted. All
costs requested must be costs that are allowable on the parent grant. </p>
<p class=regulartext>This opportunity does not preclude additional requests for
administrative supplements on other NIH grant programs or for these mechanisms.
Institutes and Centers will still consider such requests on a case-by-case
basis.</p>
<p class=regulartext>Funds provided by NIH through these supplements cannot
duplicate nor overlap with reimbursement provided by FEMA, under a contract for
insurance, or by self-insurance. </p>
<p class=regulartext><a href="#_Section_VIII._Other">See Section VIII. Other Information
for award authorities and regulations.</a></p>
<div class="heading2"><a name="_Section_II._Award_1"></a>Section II. Award Information</div>
<table class=regulartextTable border=1 cellspacing=0 cellpadding=0 width="100%">
<div class="row">
<div class="col-md-4 datalabel">Funding Instrument</div>
<div class="col-md-8 datacolumn"><p class=regulartext>The funding instrument will be the same as the parent
award. </p>
<p class=regulartext>Grant: A support mechanism providing money, property, or
both to an eligible entity to carry out an approved project or activity.</p>
<p class=regulartext>Cooperative Agreement: A support 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></div>
</div><!--end row-->
<div class="row">
<div class="col-md-4 datalabel">Application Types Allowed</div>
<div class="col-md-8 datacolumn"><p class=regulartext>Non-competing Administrative Supplements</p></div>
</div><!--end row-->
<div class="row">
<div class="col-md-4 datalabel">Clinical Trial?</div>
<div class="col-md-8 datacolumn"><p class=regulartext>Optional: Accepting applications that either propose or do
not propose clinical trial(s)</p>
<p class=regulartext>Administrative supplement applications
may not propose changes to the overall human subjects or clinical trial designation
of the award.</p>
<p class=regulartext><a
href="https://grants.nih.gov/grants/guide/url_redirect.php?id=82370">Need
help determining whether you are doing a clinical trial?</a></p></div>
</div><!--end row-->
<div class="row">
<div class="col-md-4 datalabel">Funds Available and Anticipated Number of Awards </div>
<div class="col-md-8 datacolumn"><p class=regulartext>The number of awards is contingent upon funds received by
the NIH from the Consolidated Appropriations Act, 2023 (Public Law 117-328), and
the submission of a sufficient number of meritorious applications.</p>
<p class=regulartext>The NIH intends to commit up to $25 million; awards
will be made in FY23-FY24.</p></div>
</div><!--end row-->
<div class="row">
<div class="col-md-4 datalabel">Award Budget</div>
<div class="col-md-8 datacolumn"><p class=regulartext>This funding mechanism provides for the following options:
</p>
<p class=regulartext>1) Funded Extension: Recipients may request a funded
extension at the same funding level as the current year of the
grant. The active grant can have multiple future years still committed,
e.g., it need not be in the final year. For those approved for funding,
the extension will be funded as a 24-month extension of the current budget
period; however, the funding provided will be equivalent to 12 months of
support based on the funding level of the current budget period. </p>
<p class=regulartext>2) One-time Administrative Supplements: Recipients
may request </p>
<p class=P_SingleIndent>a) up to $150,000 in direct costs (excluding
consortium F&A costs) to replace lost and/or damaged research resources
such as small pieces of equipment or their repair, supplies, reagents,
animals, etc.; and/or;</p>
<p class=P_SingleIndent> </p>
<p class=P_SingleIndent>b) up to $250,000 to replace a single item of
equipment so long as that request is accompanied by well-documented support
for the need to replace that item of equipment; and/or </p>
<p class=P_SingleIndent> </p>
<p class=P_SingleIndent>c) minor alternation and renovation (A&R) to
research facilities up to $500,000 (see Sec. 10.8.2, Alteration and
Renovation Projects Under Non-Construction Grants, of the NIH Grant Policy
Statement.). </p>
<p class=P_SingleIndent> </p>
<p class=regulartext>Excluded from the one-time supplement options are
salaries, training costs, travel and recurring supplies (only replacement
supplies can be requested).</p>
<p class=regulartext>If both a funded extension and one-time administrative
supplement(s) are approved and awarded, the funds requested in the supplement
may not duplicate any costs requested in the funded extension.</p>
<p class=regulartext>The funding mechanism being used to support this program,
administrative supplements, can be used to cover cost increases that are
associated with achieving certain new research objectives, as long as the
research objectives are within the original scope of the peer reviewed and approved
project, or the cost increases are for unanticipated expenses within the original
scope of the project. Any cost increases need to result from making
modifications to the project that would increase or preserve the overall impact
of the project consistent with its originally approved objectives and purposes.
</p></div>
</div><!--end row-->
<div class="row">
<div class="col-md-4 datalabel">Award Project Period</div>
<div class="col-md-8 datacolumn"><p class=P_SingleIndent>1. For the funded extension
option, the application will request 24 months of additional time. </p>
<p class=P_SingleIndent> </p>
<p class=regulartext>2. For the one-time administrative supplement and minor
A&R options, the project and budget period must be within the currently
approved project period for the existing award if at least 24 months remain. An
extension of the current project period may be requested if less than 24
months remain in the current period. </p></div>
</div><!--end row-->
</table>
<p class="regulartext" style="clear:both;">NIH grants policies as
described in the <i><a
href="//grants.nih.gov/grants/guide/url_redirect.php?id=11120">NIH Grants
Policy Statement</a></i> will apply
to the applications submitted and awards made from this NOFO.</p>
<div class="heading2"><a
name="_Hlk101171112"></a><a name="_Toc258873268"></a><a
name="_Section_III._Eligibility"></a>Section III. Eligibility
Information</div>
<div class="heading3">1. Eligible Applicants</div>
<div class="heading4">Eligible Organizations</div>
<p class=regulartext>Eligibility is limited to institutions
located in a county or parish where a major disaster has been declared under
the Stafford Act as a result of Hurricanes Fiona and Ian.</p>
<ul>
<li>
Applicants should first assess the impact of the hurricanes on a
particular project, including time lost and the additional work necessary to
restore the project in order to address the approved aims and objective.
Recipients will need to wait until after such an assessment has been completed
before applying.</li>
</ul>
<p class=regulartext>This announcement is for supplements to existing projects.
To be eligible, the parent award must be active, and the award must have been
active at the time of the hurricanes. Applications will be considered from
parent awards currently in a no-cost extension, only if the extension was
requested due to the impacts of Hurricanes Fiona and Ian. Applicants must
provide a justification demonstrating the reason the award was extended.</p>
<p class=regulartext>IMPORTANT: The research proposed by the NIH recipient in the
supplement application must be within the original scope of the NIH-supported
grant project. </p>
<div class="heading4">Foreign Institutions</div>
<p class=regulartext>Non-domestic (non-U.S.) Entities (Foreign Institutions) <b>are
not</b> eligible to apply.</p>
<p class=regulartext>Non-domestic (non-U.S.) components of U.S. Organizations <b>are not</b> eligible
to apply.</p>
<p class=regulartext>Foreign components, as <a
href="//grants.nih.gov/grants/guide/url_redirect.php?id=11118">defined in
the<i> NIH Grants Policy Statement</i></a>, <b>are not</b> allowed. </p>
<div class="heading4">Required Registrations</div>
<p class=regulartext><strong>Applicant
Organizations</strong></p>
<p class=regulartext>Applicant organizations must complete and maintain the following
registrations as described in the SF 424 (R&R) Application Guide to be
eligible to apply for or receive an award. Since administrative supplements are
made against active grants and cooperative agreements, many of these registrations
may already be in place. 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. The <a
href="//grants.nih.gov/grants/guide/notice-files/NOT-OD-15-039.html">NIH Policy
on Late Submission of Grant Applications</a> states that failure to complete
registrations in advance of a due date is not a valid reason for a late
submission.</p>
<ul>
<li>
<a
href="https://grants.nih.gov/grants/guide/url_redirect.php?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="//grants.nih.gov/grants/guide/url_redirect.php?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.php?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 registration;
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="//grants.nih.gov/grants/guide/url_redirect.php?id=82300">Grants.gov</a>
Applicants must have an active SAM registration in order to complete the
Grants.gov registration. </li>
</ul>
<p class=regulartext><strong>Program
Directors/Principal Investigators (PD(s)/PI(s)) </strong></p>
<p class=regulartext>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 class="heading4">Eligible Individuals (Program Director/Principal Investigator)</div>
<p class=regulartext>Individual(s) must hold an active grant or cooperative
agreement, and the research proposed in the supplement must be accomplished
within the competitive segment of the active award. Individuals are encouraged to
work with their organizations to develop applications for support. Individuals
from diverse backgrounds, including underrepresented racial and ethnic groups, individuals
with disabilities, and women are always encouraged to apply for NIH support.<br>
For supplements to parent awards that include multiple PDs/PIs, the supplement
may be requested by any or all of the PDs/PIs (in accordance with the existing
leadership plan) and submitted by the awardee institution of the parent award. Do
not use this administrative supplement application to add, delete, or change the
PDs/PIs listed on the parent award. Visit the Multiple Program Director/Principal
Investigator Policy in the SF424 (R&R) Application Guide for more information.
</p>
<div class="heading3">2. Cost Sharing</div>
<p class=regulartext>This NOFO does not require cost sharing as defined in the <a
href="//grants.nih.gov/grants/guide/url_redirect.php?id=11126"><i>NIH
Grants Policy Statement</i>.</a></p>
<div class="heading3"><a name="_3._Additional_Information"></a>3. Additional Information on Eligibility</div>
<div class="heading4">Number of Applications</div>
<p class=regulartext>Applicant organizations may submit more than one application,
provided that each is sufficiently distinct from any other administrative supplement
currently under consideration by the awarding NIH Institute or Center. <a
name="_Toc258873269"></a><a name="_Section_IV._Application"></a></p>
<p class=regulartext>Since applications to this announcement will only receive administrative
review by the awarding Institute or Center, and will not receive a peer review,
the NIH policy on resubmissions will not apply. However, applications not accepted
by the Institute or Center for review, or not funded by the Institute or Center,
should not be submitted again without either responding to any written concerns
or contacting the awarding Institute or Center for instructions. </p>
<div class="heading2"><a
name="_Section_IV._Application_1"></a>Section IV. Application
and Submission Information</div>
<div class="heading3">1. Requesting an Application
Package</div>
<p class=regulartext>Applicants must prepare applications using current forms in
accordance with the Application Guide.</p>
<p class=regulartext>The application forms package specific to this opportunity
must be accessed through <a
href="https://grants.nih.gov/grants/how-to-apply-application-guide/prepare-to-apply-and-register/submission-options/assist.htm">ASSIST</a>, <a
href="https://www.grants.gov/applicants/workspace-overview.html">Grants.gov Workspace</a> or an
institutional system-to-system solution. Applicants are encouraged to contact
the administrative office for instructions if you plan to use an institutional
system-to-system solution.</p>
<div class="heading3"><a name="_2._Content_and"></a>2. Content and Form of Application Submission</div>
<p class=regulartext>All forms must be completed for the supplemental activities <b>only</b>
and must not reflect funding or activities for the previously awarded parent
award.</p>
<p class=regulartext>It is critical that applicants follow the instructions for
their submission option (<a
href="https://grants.nih.gov/grants/guide/url_redirect.php?id=82400">SF424 (R&R)
Application Guide</a>, as appropriate) except where instructed in this notice
of funding opportunity announcement to do otherwise. Conformance to documented requirements
is required and strictly enforced. Applications that are out of compliance with
these instructions may be delayed or not accepted for review.</p>
<div class="heading4">Page Limitations</div>
<p class=regulartext>All page limitations applicable to the parent award as
described in the Application Guide and the <a
href="//grants.nih.gov/grants/guide/url_redirect.php?id=11132">Table of
Page Limits</a> for the activity code of the parent award must be followed,
with the following exceptions or additional requirements, and/or except where
instructed in a Notice of Special Interest (NOSI) to do otherwise:</p>
<div class="heading4">Application Submission</div>
<p class=regulartext>Administrative supplement requests must be submitted through
Grants.gov using electronic submission processes. </p>
<p class=heading4Indent>Instructions for Electronic
Application Submission </p>
<p class=P_SingleIndent>Use the Apply button(s) in Part I of this
announcement to access the application forms package posted at Grants.gov. If
presented with more than one form package, use the Competition ID and Competition
Titles provided to determine the most appropriate application forms package for
your situation.</p>
<p class=P_SingleIndent>Prepare applications using the SF424 (R&R) forms
associated with the chosen package. Please note that some forms marked optional
in the application package are required for submission of applications for this
announcement. Follow all instructions in the <a
href="//grants.nih.gov/grants/funding/424/index.htm">SF424 (R&R) Application
Guide</a> to ensure you complete all appropriate required and optional forms,
with the following additional guidance:</p>
<ul>
<li>SF424
R&R Cover form: Select Revision in the Type of Application field. The "Descriptive
Title of the Applicant's Project" must match the title of the currently
funded grant.</li>
<li>R&R
Other Project Information form: If applicable, attach PDF documents in the
Other Attachments field indicating that the proposed research experience was
approved by the Institutional Animal Care and Use Committee (IACUC) or human
subjects Institutional Review Board (IRB) at the recipient institution. Name
the documents IACUC Documentation.pdf and/or IRB Documentation.pdf .
Adherence to the NIH policy for including women and minorities in clinical studies
must also be ensured, if additional human subjects involvement is planned for
the supplement. </li>
<li>Project/Performance
Site Location(s) form: Include the primary site where the proposed supplement
activities will be performed. If a portion of the proposed supplement
activities will be performed at any other site(s), identify the locations in
the fields provided.</li>
<li>Sr/Key
Person Profile (Expanded) form: List the PD/PI as the first person (regardless
of their role on the supplement activities). List any other Senior/Key Personnel
who are being added through this supplement, or for whom additional funds are
being requested through this supplement; include a biographical sketch for
each.</li>
<li>Budget
forms (e.g., R&R Budget, PHS 398 Training Budget): Only include funds requested
for the additional supplement activities.</li>
<li>Research
Plan form (e.g., PHS 398 Research Plan form, PHS 398 Research Training Program
Plan): At a minimum, the Research Strategy section should be completed and must
include a summary or abstract of the funded parent award or project. Other sections
should also be included if they are being changed by the proposed supplement activities.</li>
</ul>
<div class="heading3">3. Unique Entity Identifier
and System for Award Management (SAM)</div>
<p class=regulartext>See Part 1. Section III.1 for information regarding the
requirement for obtaining a unique entity identifier and for completing and
maintaining active registrations in System for Award Management (SAM), NATO
Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and
Grants.gov.</p>
<div class="heading3">4. Submission Dates and
Times</div>
<p class=regulartext><a href="#_Part_1._Overview">Part I. Overview Information</a>
contains information about Key Dates and Times. Applicants are encouraged to submit
electronic applications before the due date to ensure they have time to make
any application corrections that might be necessary for successful submission. When
a submission date falls on a weekend or <a
href="https://www.opm.gov/policy-data-oversight/snow-dismissal-procedures/federal-holidays/">Federal
holiday</a>, the application deadline is automatically extended to the next
business day.</p>
<p class=regulartext><strong>Applicants
are responsible for viewing their electronic application before the due date in
the <a href="https://grants.nih.gov/grants/guide/url_redirect.php?id=11123">eRA Commons</a> to ensure accurate and
successful submission. </strong></p>
<p class=regulartext>For electronic application submission, information on the
submission process and a definition of on-time submission are provided in the SF424(R&R)
Application Guide.</p>
<div class="heading3">5. Intergovernmental Review
(E.O. 12372)</div>
<p class=regulartext>This initiative is not subject to <a
href="https://grants.nih.gov/grants/policy/nihgps/html5/section_10/10.10.1_executive_orders.htm">intergovernmental
review.</a> </p>
<div class="heading3"><a name="_5._Funding_Restrictions"></a>6. Funding Restrictions</div>
<p class=regulartext>All NIH awards are subject to the terms and conditions, cost
principles, and other considerations described in the <i><a
href="//grants.nih.gov/grants/guide/url_redirect.php?id=11120">NIH Grants
Policy Statement</a></i>. </p>
<p class=regulartext>This funding opportunity is for those investigators and
institutions impacted by Hurricanes Fiona and Ian, with NIH grants active at
the time of the storm. Eligibility is limited to institutions located in
a county or parish where a major disaster has been declared under the Stafford
Act as a result of Hurricanes Fiona and Ian. All NIH awards are subject to the
terms and conditions, cost principles, and other considerations described in
the NIH Grants Policy Statement with the exceptions noted below.</p>
<p class=regulartext>Pre-award costs are allowable only as described in the <i><a
href="//grants.nih.gov/grants/guide/url_redirect.php?id=11143">NIH Grants
Policy Statement</a></i>. </p>
<p class=regulartext>For the Funded Extension Option, funds are restricted to the
same level of funding as the current year of the grants. All costs must be
allowable under the terms and conditions of the parent award.</p>
<p class=regulartext>For the one-time administrative supplements option: </p>
<p class=P_SingleIndent>a) Funds are restricted to up to $150,000 in direct
costs (excluding consortium F&A costs) to replace lost and/or damaged
research resources such as small pieces of equipment or their repair, supplies,
reagents, animals, etc.; and/or;</p>
<p class=P_SingleIndent>b) Recipients may request up to $250,000 to replace a
single item of equipment so long as that request is accompanied by
well-documented support for the need to replace that item of equipment; and/or </p>
<p class=P_SingleIndent>c) minor alternation and renovation (A&R) to
research facilities up to $500,000 (see Sec. 10.8.2, Alteration and Renovation
Projects Under Non-Construction Grants, of the NIH Grant Policy Statement.).</p>
<p class=regulartext>Excluded from the one-time supplement options are salaries,
training costs, travel and recurring supplies (only replacement supplies can be
requested).</p>
<p class=regulartext>If both a funded extension and one-time administrative
supplement(s) are approved and awarded, the costs requested in the supplement may
not duplicate any costs requested in the funded extension. </p>
<p class=regulartext>Funds will be restricted so that they cannot duplicate costs
reimbursed by FEMA, under a contract for insurance or self-insurance. If during
the period of the award a claim is paid which provides such duplication, the recipient
will be required to pay back the funds to the NIH.</p>
<div class="heading3">7. Other Submission Requirements
and Information</div>
<p class=regulartext>Applications must be submitted using the instructions
specified above. </p>
<p class=regulartext><b>Applicants must complete all required registrations prior
to submission.</b> <span class=P_SingleIndent><a href="#_Section_III._Eligibility">Section III.
Eligibility Information</a></span> contains information about registration.</p>
<p class=regulartext>For assistance with your electronic application or for more information on the electronic submission
process, visit <a
href="https://grants.nih.gov/grants/how-to-apply-application-guide.html">How to
Apply Application Guide</a>. If you encounter a system issue beyond your
control that threatens your ability to complete the submission process on-time,
you must follow the <a
href="https://grants.nih.gov/grants/how-to-apply-application-guide/due-dates-and-submission-policies/dealing-with-system-issues.htm">Dealing
with System Issues</a> guidance. For assistance with application submission
contact the Application Submission Contacts in <span class=P_SingleIndent><a href="#_Section_VII._Agency">Section
VII</a></span>.</p>
<p class=P_SingleIndent><strong>Important
reminders:<br>
</strong>For applications submitted electronically on the SF424
(R&R) Application forms, all PD(s)/PI(s) must include their eRA Commons ID
in the Credential field of the Senior/Key Person Profile form. Failure to
register in the eRA Commons and to include a valid PD/PI Commons ID in the credential
field will prevent the successful submission of an electronic application to NIH.</p>
<p class=P_SingleIndent>The applicant organization must ensure that the unique
entity identifier provided on the application is the same identifier used in
the organization&rsquo;s profile in the eRA Commons and for the System for Award
Management. Additional information may be found in the SF424 (R&R)
Application Guide.</p>
<p class=regulartext><a name="_Toc258873270"> </a></p>
<div class="heading4">Post Submission Materials</div>
<p class=regulartext>Not Applicable</p>
<div class="heading2"><a name="_Section_V._Application"></a>Section V. Application Review Information</div>
<div class="heading3"><a name="_1._Criteria"></a>1.
Criteria</div>
<p class=regulartext>Administrative Supplements do not receive peer review. Instead,
the administrative criteria described below will be considered in the administrative
evaluation process. </p>
<p class=regulartext>The staff of the NIH awarding component will evaluate requests
for a supplement to determine its overall merit. The following general criteria
will be used:</p>
<p class=heading4Indent>Budget and Period
of Support</p>
<p class=regulartext>NIH staff will consider whether the
budget and the requested period of support are fully justified and reasonable
in relation to the proposed research.</p>
<p class=heading4Indent>Overall Impact</p>
<p class=P_SingleIndent>NIH staff will consider the ability of the proposed
supplement activities to increase or preserve the parent award&rsquo;s overall impact
within the original scope of award:</p>
<ul>
<li>
Will the administrative supplement increase or preserve the
likelihood for the project to exert a sustained, powerful influence on the research
field(s) involved?</li>
<li>
Will the administrative supplement increase or preserve the
likelihood that the fellowship will enhance the candidate's potential for, and
commitment to, a productive, independent scientific research career in a
health-related field?</li>
<li>
Will the administrative supplement increase or preserve the likelihood
for the candidate to maintain a strong research program?</li>
<li>
Will the administrative supplement increase or preserve the likelihood
for the program to exert a sustained, powerful influence on the research field(s)
involved?</li>
<li>
Will the administrative supplement increase or preserve the potential
benefit of the instrument requested for the overall research community and its potential
impact on NIH-funded research?</li>
</ul>
<p class=regulartext>In addition, each of the following criteria will be evaluated
as applicable for the proposed supplement. </p>
<div class="heading4">Protections for Human Subjects: </div>
<p class=regulartext>For research that involves human
subjects but does not involve one of the categories of research that are exempt
under 45 CFR Part 46, NIH staff will evaluate the justification for involvement
of human subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.</p>
<p class=regulartext>For research that involves human
subjects and meets the criteria for one or more of the categories of research
that are exempt under 45 CFR Part 46, NIH staff will evaluate: 1) the justification
for the exemption, 2) human subjects involvement and characteristics, and 3)
sources of materials. For additional information on review of the Human Subjects
section, please refer to the <a
href="//grants.nih.gov/grants/guide/url_redirect.php?id=11175">Guidelines
for the Review of Human Subjects</a>.</p>
<div class="heading4">Inclusion of Women, Minorities,
and Individuals Across the Lifespan</div>
<p class=regulartext>When the proposed project involves human subjects and/or NIH-defined
clinical research, the committee will evaluate the proposed plans for the inclusion
(or exclusion) of individuals on the basis of sex/gender, race, and ethnicity,
as well as the inclusion (or exclusion) of individuals of all ages (including
children and older adults) to determine if it is justified in terms of the scientific
goals and research strategy proposed. </p>
<div class="heading4">Vertebrate Animals</div>
<p class=regulartext>NIH staff will evaluate the
involvement of live vertebrate animals as part of the scientific assessment according
to the following five points: (1) description of proposed procedures involving animals,
including species, strains, ages, sex, and total number to be used; (2) justifications
for the use of animals versus alternative models and for the appropriateness of
the species proposed; (3) interventions to minimize discomfort, distress, pain
and injury; and (4) justification for euthanasia method if NOT consistent with
the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the
use of chimpanzees as they would any other application proposing the use of
vertebrate animals. For additional information on review of the Vertebrate
Animals section, please refer to the <a
href="//grants.nih.gov/grants/guide/url_redirect.php?id=11150">Worksheet
for Review of the Vertebrate Animal Section.</a></p>
<div class="heading4">Biohazards</div>
<p class=regulartext>NIH staff will assess whether
materials or procedures proposed are potentially hazardous to research
personnel and/or the environment, and if needed, determine whether adequate protection
is proposed.</p>
<div class="heading3">2. Review and Selection
Process </div>
<p class=regulartext>Administrative supplement requests will undergo an administrative
evaluation by NIH staff, but not a full peer review. Applications submitted for
this funding opportunity will be assigned to the awarding component for the parent
award and will be administratively evaluated using the criteria shown above.<br>
<br>
</p>
<div class="heading3"><a name="_3._Anticipated_Announcement"></a>3. Anticipated Announcement and Award Dates</div>
<p class=regulartext>Not Applicable </p>
<div class="heading2"><a name="_Toc258873271"></a><a
name="_Section_VI._Award"></a>Section VI. Award Administration
Information</div>
<div class="heading3">1. Award Notices</div>
<p class=regulartext>A formal notification in the form of a Notice of Award (NoA)
will be provided to the applicant organization for successful applications. This
may be as an NoA for the supplemental activities only; alternatively, it may be
as either a revision to the current year NoA or included as part of a future
year NoA. The NoA signed by the grants management officer is the authorizing
document and will be sent via email to the recipient&rsquo;s business official. </p>
<p class=regulartext>Recipients must comply with any funding restrictions described
in <a href="#_5._Funding_Restrictions">Section IV.5. Funding Restrictions</a>. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.</p>
<p class=regulartext>Any application awarded in response to this NOFO will be
subject to terms and conditions found on the <a
href="https://grants.nih.gov/grants/policy/nihgps/HTML5/part_ii_subpart_b.htm">Award
Conditions and Information for NIH Grants</a> website. This includes any
recent legislation and policy applicable to awards that is highlighted on this website.
When calculating the award for additional funds, NIH will 1) prorate funding if
the requested budget period is adjusted at the time of award, and 2) use the
institution&rsquo;s current F&A rate; i.e., the rate in effect when the new
funding is provided.</p>
<div class="heading3">2. Administrative and
National Policy Requirements</div>
<p class=regulartext>All NIH grant and cooperative agreement
awards include the <a
href="//grants.nih.gov/grants/guide/url_redirect.php?id=11120">NIH Grants
Policy Statement</a> as part of the NoA. For these terms of award, see the <a
href="//grants.nih.gov/grants/guide/url_redirect.php?id=11157">NIH Grants
Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A:
General</a> and <a
href="//grants.nih.gov/grants/guide/url_redirect.php?id=11159">Part II: Terms
and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for
Specific Types of Grants, Recipients, and Activities</a>, including of note, but
not limited to:</p>
<ul>
<li>
<a
href="https://grants.nih.gov/grants/policy/nihgps/HTML5/section_3/3.1_federalwide_standard_terms_and_conditions_for_research_grants.htm">Federalwide
Research Terms and Conditions</a> </li>
<li>
<a
href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-041.html">Prohibition
on Certain Telecommunications and Video Surveillance Services or Equipment</a> </li>
<li>
<a
href="https://grants.nih.gov/grants/policy/nihgps/HTML5/section_4/4.2.1_acknowledgement_of_federal_funding.htm">Acknowledgment of Federal Funding</a> </li>
</ul>
<p class=regulartext>If a recipient is successful and receives a Notice of Award,
in accepting the award, the recipient agrees that any activities under the award
are subject to all provisions currently in effect or implemented during the
period of the award, other Department regulations and policies in effect at the
time of the award, and applicable statutory provisions.</p>
<p class=regulartext>Should the applicant organization successfully compete for
an award, recipients of federal financial assistance (FFA) from HHS will be
required to complete an HHS Assurance of Compliance form (HHS 690) in which the
recipient agrees, as a condition of receiving the grant, to administer programs
in compliance with federal civil rights laws that prohibit discrimination on
the basis of race, color, national origin, age, sex and disability, and
agreeing to comply with federal conscience laws, where applicable. This
includes ensuring that entities take meaningful steps to provide meaningful
access to persons with limited English proficiency; and ensuring effective
communication with persons with disabilities. Where applicable, Title XI and
Section 1557 prohibit discrimination on the basis of sexual orientation, and
gender identity, The HHS Office for Civil Rights provides guidance on complying
with civil rights laws enforced by HHS. See <a
href="https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.hhs.gov%2Fcivil-rights%2Ffor-providers%2Fprovider-obligations%2Findex.html&data=05%7C01%7Ccarrie.mitchell%40nih.gov%7Ce8bc304bfdb644bb556e08dac343ad36%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638036992699510830%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=AY%2F1fYgD%2Bbumf5GYC6piwPsEJ1H0G3yetf%2FtOjaSPuc%3D&reserved=0">https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html</a>
and <a
href="https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.hhs.gov%2Fcivil-rights%2Ffor-individuals%2Fnondiscrimination%2Findex.html&data=05%7C01%7Ccarrie.mitchell%40nih.gov%7Ce8bc304bfdb644bb556e08dac343ad36%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638036992699510830%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=FVdcrY38rDvkbEyNG7CJUvclJYXUTpr1UiZmJQY0GoI%3D&reserved=0">https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html</a>.</p>
<p class=regulartext>HHS recognizes that research projects are often limited in
scope for many reasons that are nondiscriminatory, such as the principal investigator s
scientific interest, funding limitations, recruitment requirements, and other
considerations. Thus, criteria in research protocols that target or exclude certain
populations are warranted where nondiscriminatory justifications establish that
such criteria are appropriate with respect to the health or safety of the subjects,
the scientific study design, or the purpose of the research. For additional
guidance regarding how the provisions apply to NIH grant programs, please contact
the Scientific/Research Contact that is identified in Section VII under Agency
Contacts of this NOFO.</p>
<ul>
<li>
For guidance on meeting the legal obligation to take reasonable
steps to ensure meaningful access to programs or activities by limited English
proficient individuals see <a
href="https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html">https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html</a> and <a
href="https://www.lep.gov/">https://www.lep.gov</a>.</li>
<li>
For information on an institution's specific legal obligations
for serving qualified individuals with disabilities, including reasonable accommodations
and making services accessible to them, see see <a href="https://www.hhs.gov/ocr/civilrights/understanding/disability/index.html">http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html</a>.</li>
<li>
HHS funded health and education programs must be administered in an
environment free of sexual harassment, see <a
href="https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html">https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html</a>.
For information about NIH's commitment to supporting a safe and respectful work
environment, who to contact with questions or concerns, and what NIH's expectations
are for institutions and the individuals supported on NIH-funded awards, please
see <a href="https://grants.nih.gov/grants/policy/harassment.htm">https://grants.nih.gov/grants/policy/harassment.htm</a>.
</li>
<li>
For guidance on administering programs in compliance with applicable
federal conscience protection and associated anti-discrimination laws see <a
href="https://www.hhs.gov/conscience/conscience-protections/index.html">https://www.hhs.gov/conscience/conscience-protections/index.html</a>
and <a href="https://www.hhs.gov/conscience/religious-freedom/index.html">https://www.hhs.gov/conscience/religious-freedom/index.html</a>.
</li>
</ul>
<p class=regulartext>Please contact the HHS Office for Civil Rights for more information
about obligations and prohibitions under federal civil rights laws at <a
href="https://www.hhs.gov/ocr/about-us/contact-us/index.html">https://www.hhs.gov/ocr/about-us/contact-us/index.html</a>
or call 1-800-368-1019 or TDD 1-800-537-7697. </p>
<p class=regulartext>In accordance with the statutory
provisions contained in Section 872 of the Duncan Hunter National Defense
Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be
subject to the Federal Awardee Performance and Integrity Information System (FAPIIS)
requirements. FAPIIS requires Federal award making officials to review and consider
information about an applicant in the designated integrity and performance system
(currently FAPIIS) prior to making an award. An applicant, at its option, may
review information in the designated integrity and performance systems accessible
through FAPIIS and comment on any information about itself that a Federal
agency previously entered and is currently in FAPIIS. The Federal awarding
agency will consider any comments by the applicant, in addition to other information
in FAPIIS, in making a judgement about the applicant&rsquo;s integrity, business
ethics, and record of performance under Federal awards when completing the
review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR
Part 200.206 Federal awarding agency review of risk posed by applicants.
This provision will apply to all NIH grants and cooperative agreements except
fellowships.</p>
<p class=heading4>Cooperative Agreement Terms and Conditions of Award</p>
<p class=regulartext>Any supplements to Cooperative Agreements will be subject to
the same Cooperative Agreement terms and conditions as the parent award.</p>
<div class="heading3">3. Data Management and Sharing</div>
<p class=regulartext>Note: The NIH Policy for Data Management and Sharing is effective
for due dates on or after January 25, 2023. </p>
<p class=regulartext>Any supplements will be subject to the same data management
and sharing requirements as the parent award. </p>
<p class=regulartext>Consistent with the NIH Policy for Data Management and Sharing,
when data management and sharing is applicable to the award, recipients will be
required to adhere to the Data Management and Sharing requirements as outlined
in the <a
href="https://grants.nih.gov/grants/policy/nihgps/HTML5/section_8/8.2.3_sharing_research_resources.htm#Data">NIH
Grants Policy Statement</a>. Upon the approval of a Data Management and Sharing
Plan, it is required for recipients to implement the plan as described. </p>
<div class="heading3">4. Reporting</div>
<p class=regulartext>Reporting requirements will be specified in the terms and
conditions of award as applicable to the supplemental activities. In most non-competing
continuation applications, the progress report and budget for the supplement
must be included with, but clearly delineated from, the progress report and budget
for the parent award. The progress report must include information about the
activities supported by the supplement even if support for future years is not
requested. Continuation of support for the supplement activities in the remaining
years of the competitive segment of the grant will depend upon satisfactory
review by the NIH awarding component of progress for both the parent award and
the supplement project, the research proposed for the next budget period, and
the appropriateness of the proposed budget for the proposed effort. This
information is submitted with the <a
href="//grants.nih.gov/grants/rppr/index.htm">Research Performance
Progress Report (RPPR)</a> and financial statements as required in the <a
href="https://grants.nih.gov/grants/policy/nihgps/HTML5/section_8/8.4.1_reporting.htm">NIH
Grants Policy Statement</a>. NIH NOFOs outline intended research goals and objectives.
Post award, NIH will review and measure performance based on the details and
outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301
and 2 CFR 200.301</p>
<p class=regulartext>Funds awarded for supplements will be issued in unique
subaccounts in the HHS Payment Management System and will require separate
financial reporting from any other funds awarded.</p>
<p class=regulartext>The Federal Funding Accountability and Transparency Act of
2006 (Transparency Act), includes a requirement for recipients of Federal
grants to report information about first-tier subawards and executive compensation
under Federal assistance awards issued in FY2011 or later. All recipients of
applicable NIH grants and cooperative agreements are required to report to
the Federal Subaward Reporting System (FSRS) available at <a
href="//grants.nih.gov/grants/guide/url_redirect.php?id=11170">www.fsrs.gov</a>
on all subawards over the threshold. See the <i><a
href="https://grants.nih.gov/grants/policy/nihgps/HTML5/section_4/4.1.8_federal_funding_accountability_and_transparency_act__ffata_.htm">NIH
Grants Policy Statement</a></i> for additional information on this reporting requirement.
</p>
<p class=regulartext>In accordance with the regulatory requirements provided at
45 CFR 75.113 and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR
Part 200, recipients that have currently active Federal grants, cooperative
agreements, and procurement contracts from all Federal awarding agencies with a
cumulative total value greater than $10,000,000 for any period of time during
the period of performance of a Federal award, must report and maintain the
currency of information reported in the System for Award Management
(SAM) about civil, criminal, and administrative proceedings in connection
with the award or performance of a Federal award that reached final disposition
within the most recent five-year period. The recipient must also make
semiannual disclosures regarding such proceedings. Proceedings information
will be made publicly available in the designated integrity and performance system
(currently FAPIIS). This is a statutory requirement under section 872 of
Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of
Public Law 111-212, all information posted in the designated integrity and
performance system on or after April 15, 2011, except past performance reviews
required for Federal procurement contracts, will be publicly available. Full
reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75
and 2 CFR Part 200 Award Term and Condition for Recipient Integrity and Performance
Matters.</p>
<div class="heading2"><a name="_Toc258873272"></a><a
name="_Section_VII._Agency"></a>Section VII. Agency Contacts</div>
<p class=regulartext>We encourage inquiries concerning this funding opportunity and
welcome the opportunity to answer questions from potential applicants.</p>
<div class="heading4">Application Submission Contacts</div>
<p class=regulartext>eRA Service Desk (Questions
regarding ASSIST, eRA Commons, application errors and warnings, documenting
system problems that threaten submission by the due date, and post-submission issues)</p>
<p class=regulartext>Finding Help Online: <a
href="https://www.era.nih.gov/need-help" target="_blank"
title="https://www.era.nih.gov/need-help">https://www.era.nih.gov/need-help</a> (preferred
method of contact)<br>
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)</p>
<p class=regulartext>General Grants Information (Questions regarding application instructions,
application processes, and NIH grant resources)<br>
Email: <a href="/cdn-cgi/l/email-protection#fdba8f9c93898eb4939b92bd939495d39a928b"><span class="__cf_email__" data-cfemail="4a0d382b243e3903242c250a242322642d253c">[email&#160;protected]</span></a> (preferred
method of contact)<br>
Telephone: 301-480-7075</p>
<p class=regulartext>Grants.gov Customer Support (Questions regarding Grants.gov
registration and Workspace)<br>
Contact Center Telephone: 800-518-4726<br>
Email: <a href="/cdn-cgi/l/email-protection#295a5c5959465b5d694e5b48475d5a074e465f"><span class="__cf_email__" data-cfemail="b2c1c7c2c2ddc0c6f2d5c0d3dcc6c19cd5ddc4">[email&#160;protected]</span></a></p>
<div class="heading4">Scientific/Research Contact(s)</div>
<p class=regulartext>For any scientific or research-related questions on this
administrative supplement notice please contact the Program Officer listed on
the NoA of the most recent parent award.</p>
<div class="heading4">Peer Review Contact(s)</div>
<p class=regulartext>Not Applicable</p>
<div class="heading4">Financial/Grants Management Contact(s)</div>
<p class=regulartext>For any financial or grants management questions on this
administrative supplement notice please contact the Grants Management Specialist
or Grants Management Officer listed on the NoA of the most recent parent award.
</p>
<div class="heading2"><a name="_Toc258873273"></a><a
name="_Section_VIII._Other"></a>Section VIII. Other Information</div>
<p class=regulartext>Recently issued trans-NIH <a
href="//grants.nih.gov/grants/guide/url_redirect.php?id=11163">policy
notices</a> may affect your application submission. A full list of policy notices
published by NIH is provided in the <a
href="//grants.nih.gov/grants/guide/url_redirect.php?id=11164"><i>NIH
Guide for Grants and Contracts</i></a>. All
awards are subject to the terms and conditions, cost principles, and other
considerations described in the</p>
<div class="heading4">Authority and Regulations</div>
<p class=regulartext>Awards are made under the authorization of Sections 301 and 405
of the Public Health Service Act as amended (42 USC 241 and 284) and under
Federal Regulations 42 CFR Part 52 and 45 CFR Part 75. and 2 CFR Part 200 </p>
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