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<TITLE>Expired RFA-CA-20-038: Emergency Awards: SARS-CoV-2 Serological Sciences Centers of Excellence (U54 Clinical Trial Optional)</TITLE>
<META NAME="description" CONTENT="NIH Funding Opportunities and Notices in the NIH Guide for Grants and Contracts: Emergency Awards: SARS-CoV-2 Serological Sciences Centers of Excellence (U54 Clinical Trial Optional) RFA-CA-20-038. NCI">
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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>
<div id="watermark_background">
<p id="watermark_text">EXPIRED</p>
</div>
<div class="container">
<div class="row">
<div class="col-xs-12">
<div class=WordSection1>
<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>
<p style="clear:both;"> </p>
<div class="row">
<div class="col-md-4 datalabel">Participating Organization(s)</div>
<div class="col-md-8 datacolumn"><p>National Institutes of Health (<a href="http://www.nih.gov">NIH</a>)</p></div>
</div><!--end row-->
<div class="row">
<div class="col-md-4 datalabel"><a name="_Components_of_Participating"></a>Components
of Participating Organizations</div>
<div class="col-md-8 datacolumn"><p>National Cancer Institute (<a
href="http://www.nci.nih.gov/">NCI</a>)</p>
<p>National Institute of Allergy and Infectious Diseases (<a
href="https://www.niaid.nih.gov/" target="_blank">NIAID</a>)<br>
<br>
</p></div>
</div><!--end row-->
<div class="row">
<div class="col-md-4 datalabel">Funding Opportunity Title</div>
<div class="col-md-8 datacolumn"><p class="title">Emergency Awards: SARS-CoV-2 Serological
Sciences Centers of Excellence (U54 Clinical Trial Optional) </p></div>
</div><!--end row-->
<div class="row">
<div class="col-md-4 datalabel">Activity Code</div>
<div class="col-md-8 datacolumn"><p><a
href="//grants.nih.gov/grants/funding/ac_search_results.htm?text_curr=u54&Search.x=0&Search.y=0&Search_Type=Activity">U54</a> Specialized Center- Cooperative Agreements</p></div>
</div><!--end row-->
<div class="row">
<div class="col-md-4 datalabel">Announcement Type</div>
<div class="col-md-8 datacolumn"><p>New</p></div>
</div><!--end row-->
<div class="row">
<div class="col-md-4 datalabel">Related Notices</div>
<div class="col-md-8 datacolumn"> <ul><li><b>June 25, 2020</b> - Request for Proposals (RFP) Solicitation S20-119: Serological Sciences Network Capacity Building Centers. See Notice <a href="/grants/guide/notice-files/NOT-CA-20-077.html">NOT-CA-20-077</a>.</li><li><b>June 11, 2020</b> - Pre-Application Webinar for NCI's Serological Sciences Network Funding Opportunities (RFA-CA-20-038, RFA-CA-20-039). See Notice <a href="/grants/guide/notice-files/NOT-CA-20-074.html">NOT-CA-20-074</a>.</li></ul></div>
</div><!--end row-->
<div class="row">
<div class="col-md-4 datalabel">Funding Opportunity Announcement (FOA) Number</div>
<div class="col-md-8 datacolumn"><p class="title">RFA-CA-20-038 </p></div>
</div><!--end row-->
<div class="row">
<div class="col-md-4 datalabel">Companion Funding Opportunity</div>
<div class="col-md-8 datacolumn"><p>RFA-CA-20-039, <a
href="https://grants.nih.gov/grants/funding/ac_search_results.htm?text_curr=u01&Search.x=0&Search.y=0&Search_Type=Activity">U01</a> Research Projects Cooperative Agreements </p></div>
</div><!--end row-->
<div class="row">
<div class="col-md-4 datalabel"><a name="_Number_of_Applications"></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></div>
</div><!--end row-->
<div class="row">
<div class="col-md-4 datalabel">Catalog of Federal Domestic Assistance (CFDA) Number(s)<sub> </sub></div>
<div class="col-md-8 datacolumn"><p>93.394; 93.395; 93.396; 93.855</p></div>
</div><!--end row-->
<div class="row">
<div class="col-md-4 datalabel">Funding Opportunity Purpose</div>
<div class="col-md-8 datacolumn"><p>This Funding Opportunity Announcement (FOA) is associated
with the COVID-19 Supplement funded through the Paycheck Protection Program
and Health Care Enhancement Act (P.L. 116-139) which directs the National
Cancer Institute of the NIH to develop, validate, improve, and implement
serological testing and associated technologies . The purpose of the FOA is
to establish Serological Sciences Centers of Excellence with the goal of
identifying and advancing research opportunities to characterize the immune
responses elicited by SARS-CoV-2 viral infection; understanding the
mechanisms driving the serological, humoral and cellular immune responses;
determining host, genetic, and environmental modifiers of the immune response;
determining the serological correlates of disease pathogenesis and protection
against future infection; defining access, communication, and implementation barriers
related to SARS-CoV-2 serological testing. These U54 Centers will be part of
a Serological Sciences Network (SeroNet). Other components of the Network
will include Serological Sciences Research Projects (U01), the FNLCR Serology
Laboratory, Serological Capacity Building Centers (CBC) and a Serological
Sciences Network Coordinating Center (SSNCC) which will be managed through Frederick
National Lab for Cancer Research (FNLCR), a Federally Funded Research and
Development Center. It may also include SBIR grants and other grants and
contracts related to serology associated with SARS-CoV-2. All components are
expected to collaborate across the entire Network, sharing data, results, and
reagents.</p>
<p>This FOA solicits multi-component U54 Center applications,
whereas the companion FOA, RFA-CA-20-039, solicits applications for discrete
U01 research projects. Successful applicants from both FOAs will become
members of the Serological Sciences Network. </p></div>
</div><!--end row-->
<div class="heading2" style="clear:both;">Key Dates</div>
<p style="clear:both;"> </p>
<div class="row">
<div class="col-md-4 datalabel">Posted Date</div>
<div class="col-md-8 datacolumn"><p>June 5, 2020</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>June 22, 2020 </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>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>July 22, 2020 </p>
<p>All applications are due by 5:00 PM local time of
applicant organization. All <a href="#Application Types Allowed">types of non-AIDS
applications</a> allowed for this funding opportunity announcement are due on
the listed date(s). 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>
<p>No late applications will be accepted for this FOA.</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>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>August 2020 </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>August 2020 </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>September 30, 2020</p></div>
</div><!--end row-->
<div class="row">
<div class="col-md-4 datalabel">Expiration Date</div>
<div class="col-md-8 datacolumn"><p>July 23, 2020 </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>Not Applicable</p></div>
</div><!--end row-->
<div class="heading4"><a name="_Required_Application_Instructions"></a>Required
Application Instructions</div>
<p>It is critical that applicants follow the Multi-Project (M)
Instructions in the <a
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=12000">SF424
(R&R) Application Guide</a>, except where instructed to do otherwise (in
this FOA or in a Notice from the <a href="//grants.nih.gov/grants/guide/"><i>NIH
Guide for Grants and Contracts</i></a>). Conformance to all requirements (both
in the Application Guide and the FOA) 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>
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<div class="heading1">Table of Contents</div>
<p><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><span class=P_SingleIndent><a href="#_Section_I._Funding">Section
I. 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="_Toc258873265"></a><a
name="_Toc258852635"></a><br>
<a name="_Part_2._Full"></a>Part 2.
Full Text of Announcement</div>
<div class="heading2"><a name="_Toc258873266"></a><a
name="_Toc258852636"></a><a name=IFundOppDesc></a><a name="_Section_I._Funding"></a>Section I. Funding Opportunity Description</div>
<p>This Funding Opportunity Announcement (FOA) is associated
with the COVID-19 Supplement funded through the <a
href="https://www.congress.gov/bill/116th-congress/house-bill/266/text">Paycheck
Protection Program and Health Care Enhancement Act</a> (P.L. 116-139) which
directs the National Cancer Institute of the NIH to develop, validate,
improve, and implement serological testing and associated technologies . The
purpose of the FOA is to establish Serological Sciences Centers of Excellence
with the goal of identifying and advancing research opportunities to
characterize the immune responses elicited by SARS-CoV-2 viral infection;
understanding the mechanisms driving the serological, humoral and cellular
immune responses; determining host, genetic, and environmental modifiers of the
immune response; determining the serological correlates of disease pathogenesis
and protection against future infection; defining access, communication, and
implementation barriers related to SARS-CoV-2 serological testing. These Centers
will be part of a Serological Sciences Network (SeroNet). Other components of
the Network will include Serological Sciences Research Projects (U01), the FNLCR
Serology Laboratory, Serological Capacity Building Centers (CBC) and a
Serological Sciences Network Coordinating Center (SSNCC) which will be managed
through Frederick National Lab for Cancer Research (FNLCR), a Federally Funded
Research and Development Center. It may also include SBIR grants and other
grants and contracts related to serology associated with SARS-CoV-2. SeroNet
activities will be coordinated by the SeroNet Steering Committee in which all
Network members must participate. </p>
<p>All components are expected to collaborate across the entire
Network, sharing data, results and reagents. These components are:</p>
<ul>
<li> <b>Serological Sciences Centers of Excellence (U54; this RFA) </b>
The SeroNet Centers of Excellence will carry out 2-3 projects in basic and
applied serological research to characterize the immune responses elicited by
SARS-CoV-2 viral infection, understand mechanisms driving the broad immune
responses, determine modifiers of the immune response, identify serological
correlates of disease pathogenesis and protection against future infection, or define
access, communications and implementation barriers to serological testing.</li>
<li> <b>Serological Sciences Research Projects (U01) RFA-CA-20-039 - </b>The
SeroNet Research Projects will carry out a research project in basic and
applied serological research to characterize the immune responses elicited by
SARS-CoV-2 viral infection, understand mechanisms driving the broad immune
responses, determine modifiers of the immune response; identify serological
correlates with disease pathogenesis and protection against future infection,
or define access, communications and implementation barriers to serological
testing.</li>
<li> <b>FNLCR Serology Laboratory </b> The Serology Lab will
implement and qualify SARS-CoV-2 assays, develop qualified assay standards, and
generate novel reagents. The Serology Lab will also procure and characterize
serum samples from SARS-CoV-2 patients and controls and establish serum panels.
The Serology Lab will share these assays, reagents, and standards within
SeroNet.</li>
<li> <b>FNLCR Capacity Building Centers (CBC) </b> CBCs will develop
and expand serological testing capacity and practice in the community. CBCs
will conduct serological standardization and assay development and scale up to
screening capacity to reach at least 10,000 patients per week with FDA-Emergency
Use Authorization (EUA) authorized assays.</li>
<li> <b>Serological Sciences Network Coordinating Center (SSNCC)</b><b> </b>(managed by the FNLCR) The Coordinating Center will work closely with NIH
staff and SeroNet component staff and investigators to manage all aspects of
SeroNet coordination including organizing Steering Committee and Investigator
Meetings, managing Network communication and outreach, coordinating reagent
sharing and distribution, and facilitating and coordinating Network data
management.</li>
</ul>
<p>Each proposed Serological Sciences Research Project must be
focused on research related to the serological response to SARS-CoV-2,
characterization of the innate or adaptive immune response to SARS-CoV-2, other
correlates of immunity, patient outcome and/or disease pathogenesis and the
development of novel serological assays for SARS-CoV-2, or definition of
access, communication and implementation barriers. Proposals with cancer relevance
are encouraged.</p>
<p>Applications spanning the full range of research and
research designs, from basic research to population science research, will be
considered responsive. </p>
<div class="heading4"><strong>Potential
areas of investigation include but are not limited to:</strong></div>
<ul>
<li> Developing novel assays, and preclinical and computational model
systems to test adaptive and innate immune responses to SARS-CoV-2 infection
that inform immune parameters and serological markers associated with
asymptomatic vs symptomatic infection, disease severity, risk of re-infection
or vaccine efficacy. </li>
<li> Understanding the mechanisms underlying innate, cell-mediated,
and humoral immune responses to SARS-CoV-2 including macrophage activating
syndrome and cytokine storm - as well as how disease severity differs as a
function of immune health status.</li>
<li> Determine if therapeutics (e.g. remdesivir, antivirals) and
passive antibody therapies used to treat COVID-19 modulate serologic and immune
responses to SARS-CoV-2 (e.g. antibody-dependent enhancement).</li>
<li> Characterizing the serologic differences resulting from natural
infection vs. vaccination against SARS-CoV-2, and how they correlate with the
persistence or longevity of the response. </li>
<li> Identifying genetic and epigenetic determinants (e.g. HLA types)
that modulate the development and durability of immune responses against
SARS-CoV-2 infection and associated serological correlates.</li>
<li> Understanding what factors affect the SARS-CoV-2 immune response
or pathogenesis including SARS-CoV-2 viral load, health conditions (e.g.,
diabetes, obesity, cardiovascular disease, precancerous conditions),
co-infection with other viruses (e.g., HIV, HPV, CMV), or the presence of
endemic coronavirus antibodies. </li>
<li> Understanding how precancerous conditions, cancer, and/or cancer
therapies (i.e., chemotherapy, radiation, immunotherapy, hormonal therapy,
combinations) affect serologic and immune responses to SARS-CoV-2 infection and
the clinical course of infection, and conversely how the immune response to
SARS-CoV-2 affects precancerous conditions, cancers, and responses to cancer
therapies.</li>
<li> Understanding how patient demographic factors (e.g., age, sex,
ethnicity), behavioral (e.g., smoking, physical activity), and environmental
factors affect immune or serological responses to SARS-CoV-2 infection.</li>
<li> Researching the clinical and public health implementation of
validated serologic assays, their interpretation, and follow-up for health
outcomes.</li>
<li> Approaches to promoting and ensuring equitable access
to serologic testing, identification of contextual factors associated with the
uptake of SARS-CoV-2 serologic testing, and whether differential access further
exacerbates health disparities and health outcomes.</li>
<li> Determining the ethical, legal and social implications of
serologic testing for SARS-CoV-2 in diverse populations and the best methods
for appropriate communication of results and interpretation at the individual,
provider, and population level; for example, the impact of serologic testing on
employment, housing, health insurance, access to federal benefits.</li>
</ul>
<p><b>This is an emergency FOA due to the </b><b>SARS-CoV-2 global pandemic; therefore, applicants do not need to provide extensive
background information or preliminary data in this application.</b></p>
<p>Intervention trials addressing behavioral, health care
delivery, or implementation research related to serologic testing and serologic
outcomes are appropriate for this RFA. These research efforts should include a
broad and diverse population, including consideration of age, sex, gender,
race, socioeconomic status, rural populations, ethnicity, as well as specific
vulnerable populations (e.g., individuals with comorbidities such as autoimmune
disease, immunosuppression, and obesity, medically underserved, and
cancer populations across all age groups childhood, adolescent and
young adult, and older populations). Leveraging ongoing cohort studies and
registry data is encouraged.</p>
<div class="heading4">Center Organization</div>
<p>Applications for Serological
Sciences Centers of Excellence should have the
following structure:</p>
<ul type=disc>
<li><b>Administrative
Core </b>to manage and coordinate all Center research and activities
and serve as the liaisons between the Centers and the other components of SeroNet.
Responsibilities of the Administrative Core include ensuring the data
collected conform with the agreed practice and principles of the SeroNet
Standard Operating Procedures (SOPs), Common Data Elements (CDEs) and data
sharing plan as approved by the SeroNet Steering Committee. </li>
</ul>
<ul type=disc>
<li><b>Research Projects</b> should
be well developed research programs. Each Center should include 2-3
Research Projects that closely integrate into the organizing framework and
together constitute a multifaceted approach to the serological response to
SARS-CoV-2. Leaders and senior investigators of the team will be expected
to participate in trans-SeroNet initiatives such as those focused on antibody
detection, sample preservation, clinical/epidemiological data collection,
and clinical utilization of serological testing.</li>
</ul>
<ul type=disc>
<li><b>Shared Resource
Cores </b>should provide technical, experimental, or computational
expertise that is essential to more than one Research Project within the
Center. Each Center may propose up to 2 Shared Resource Cores.</li>
</ul>
<div class="heading4">Non-Responsive Applications (out of scope):</div>
<p>Applications proposing the following topic areas would be
considered non-responsive to this FOA, and will be returned without review:</p>
<ul>
<li> Interventional clinical trials of vaccines and other therapeutics </li>
<li> Fundamental virology studies</li>
<li> The long-term impact of SARS-CoV-2 infection on co-morbidities,
unrelated to cancer or precancers.</li>
</ul>
<p>See <a href="#_Section_VIII._Other">Section VIII. Other
Information</a></span> for award authorities and regulations.</p>
<div class="heading2"><a name="_Section_II._Award_1"></a>Section II. Award Information</div>
<p style="clear:both;"> </p>
<div class="row">
<div class="col-md-4 datalabel">Funding Instrument</div>
<div class="col-md-8 datacolumn"><p>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 FOA.</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>New </p>
<p class=regulartext>The <a
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11116">OER
Glossary</a> and the SF424 (R&R) Application Guide provide details on
these application types. Only those application types listed here are allowed
for this FOA.</p></div>
</div><!--end row-->
<div class="row">
<div class="col-md-4 datalabel">Clinical Trial?</div>
<div class="col-md-8 datacolumn"><p>Optional: Accepting applications that either propose or do
not propose clinical trial(s)</p>
<p><a
href="https://grants.nih.gov/grants/guide/url_redirect.htm?id=82370">Need
help determining whether you are doing a clinical trial?</a></p></div>
</div><!--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>The number of awards is contingent upon NIH appropriations
and the submission of a sufficient number of meritorious applications. </p>
<p>NCI intends to commit $8-16 Million in FY 2020 to fund 4-8
awards. </p></div>
</div><!--end row-->
<div class="row">
<div class="col-md-4 datalabel">Award Budget</div>
<div class="col-md-8 datacolumn">Application budgets are limited $1.5 Million Direct Costs (exclusive
of third-party facilities and administration [F&A] costs) and need to
reflect the actual needs of the proposed project. </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>5 years</p></div>
</div><!--end row-->
<p>NIH grants policies as
described in the <a
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11120"><i>NIH
Grants Policy Statement</i></a> will apply
to the applications submitted and awards made from this FOA.</p>
<div class="heading2"><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>Higher Education Institutions</p>
<ul>
<li> Public/State Controlled Institutions of Higher Education </li>
<li> Private Institutions of Higher Education </li>
</ul>
<p class=P_SingleIndent>The following types of Higher Education Institutions
are always encouraged to apply for NIH support as Public or Private
Institutions of Higher Education: </p>
<p class="P_DoubleIndent">o Hispanic-serving Institutions</p>
<p class="P_DoubleIndent">o Historically Black Colleges and Universities (HBCUs)</p>
<p class="P_DoubleIndent">o Tribally Controlled Colleges and Universities (TCCUs) </p>
<p class="P_DoubleIndent">o Alaska Native and Native Hawaiian Serving Institutions</p>
<p class="P_DoubleIndent">o Asian American Native American Pacific Islander Serving
Institutions (AANAPISIs)</p>
<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>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>
<li> Eligible Agencies of the Federal Government</li>
<li> U.S. Territory or Possession</li>
</ul>
<p>Other</p>
<ul>
<li> Independent School Districts</li>
<li> Public Housing Authorities/Indian Housing Authorities</li>
<li> Native American Tribal Organizations (other than Federally
recognized tribal governments)</li>
<li> Faith-based or Community-based Organizations</li>
<li> Regional Organizations</li>
</ul>
<div class="heading4">Foreign Institutions</div>
<p>Non-domestic (non-U.S.) Entities (Foreign Institutions) <b>are
not</b> eligible to apply.<br>
Non-domestic (non-U.S.) components of U.S. Organizations <b>are not</b> eligible to apply.</p>
<p>Foreign components, as <a
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11118">defined in
the <i>NIH Grants Policy Statement</i></a>, <b>are</b> allowed. </p>
<div class="heading4">Required Registrations</div>
<p><strong>Applicant
Organizations</strong></p>
<p>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. 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="http://fedgov.dnb.com/webform" Title="Link to Non-U.S. Government Site">Dun and Bradstreet
Universal Numbering System (DUNS)</a> - All registrations require that
applicants be issued a DUNS number. After obtaining a DUNS number, applicants
can begin both SAM and eRA Commons registrations. The same DUNS number must be
used for all registrations, as well as on the grant application.</li>
<li> <a href="https://www.sam.gov/portal/public/SAM/">System for Award Management (SAM)</a> Applicants must complete and maintain an active registration, <b>which requires
renewal at least annually</b>. 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. </li>
<li>o In the case of
Emergency awards, if the applicant is unable to comply with the requirement to
complete and maintain SAM registration at the time of application submission,
contact the agency immediately.</li>
<li>o <a
href="//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> <a
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11123">eRA Commons</a> - Applicants
must have an active DUNS number to register in eRA Commons. Organizations can
register with the eRA Commons as they are working through their SAM or
Grants.gov registration, but 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.htm?id=82300">Grants.gov</a> Applicants
must have an active DUNS number and SAM registration in order to complete the
Grants.gov registration. </li>
</ul>
<p><strong>Program
Directors/Principal Investigators (PD(s)/PI(s)) </strong></p>
<p>All PD(s)/PI(s) must have an eRA Commons account.
PD(s)/PI(s) should work with their organizational officials to either
create a new account or to affiliate their existing account with the applicant
organization in eRA Commons. If the PD/PI is also the organizational Signing
Official, they must have two distinct eRA Commons accounts, one for each role.
Obtaining an eRA Commons account can take up to 2 weeks.</p>
<div class="heading4">Eligible Individuals (Program Director/Principal Investigator)</div>
<p>Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program
Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with
his/her organization to develop an application for support. Individuals from
underrepresented racial and ethnic groups as well as individuals with
disabilities are always encouraged to apply for NIH support.</p>
<p>For institutions/organizations proposing multiple PDs/PIs,
visit the Multiple Program Director/Principal Investigator Policy and
submission details in the Senior/Key Person Profile (Expanded) Component of the
SF424 (R&R) Application Guide. </p>
<div class="heading3"> </div>
<div class="heading3">2. Cost Sharing</div>
<p>This FOA does not require cost sharing as defined in the <a
href="//grants.nih.gov/grants/guide/url_redirect.htm?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>Applicant organizations may submit more than one application,
provided that each application is scientifically distinct. </p>
<p>The NIH will not accept duplicate or highly overlapping
applications under review at the same time. This means that the NIH will
not accept:</p>
<ul>
<li> A new (A0) application that is submitted before issuance of the
summary statement from the review of an overlapping new (A0) or resubmission
(A1) application.</li>
<li> A resubmission (A1) application that is submitted before issuance
of the summary statement from the review of the previous new (A0) application.</li>
<li> An application that has substantial overlap with another
application pending appeal of initial peer review (see <a
href="//grants.nih.gov/grants/guide/notice-files/NOT-OD-11-101.html">NOT-OD-11-101</a>).</li>
</ul>
<div class="heading2"><a name="_Toc258873269"></a><a
name="_Section_IV._Application_1"></a>Section IV. Application
and Submission Information</div>
<div class="heading3">1. Requesting an
Application Package</div>
<p>The application forms package specific to this opportunity
must be accessed through ASSIST or an institutional system-to-system solution. A
button to apply using ASSIST is available in <a
href="#_Required_Application_Instructions">Part 1</a> of this FOA. See your
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>It is critical that applicants follow the Multi-Project (M) Instructions
in the <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=12000">SF424
(R&R) Application Guide</a>, except where instructed in this funding
opportunity announcement to do otherwise and where instructions in the
Application Guide are directly related to the Grants.gov downloadable forms
currently used with most NIH opportunities. Conformance to the requirements in
the Application Guide 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>
<table border=1 cellspacing=0 cellpadding=0>
<thead>
<tr>
<td width=355 valign=top><p><strong>Available
Component Types </strong></p></td>
<td width=216 valign=top><p><strong>Research
Strategy/Program Plan Page Limits</strong></p></td>
</tr>
</thead>
<tr>
<td width=355 valign=top><p>Overall</p></td>
<td width=216 valign=top><p>12</p></td>
</tr>
<tr>
<td width=355 valign=top><p>Admin Core (use for Administrative Core)</p></td>
<td width=216 valign=top><p>3</p></td>
</tr>
<tr>
<td width=355 valign=top><p>Shared Resource Core (optional; use for each Core)</p></td>
<td width=216 valign=top><p>3</p></td>
</tr>
<tr>
<td width=355 valign=top><p>Project (use for each Research Project)</p></td>
<td width=216 valign=top><p>6</p></td>
</tr>
</table>
<p>Additional page limits described in the SF424 Application
Guide and the <a
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11133">Table of
Page Limits</a> must be followed.</p>
<div class="heading4">Instructions for the Submission of Multi-Component
Applications</div>
<p>The following section supplements the instructions found in
the SF424 (R&R) Application Guide, and should be used for preparing a
multi-component application. </p>
<p>The application should consist of the following components:</p>
<ul type=disc>
<li>Overall:
required</li>
<li>Administrative
Core: required, maximum of one (1)</li>
<li>Shared
Resource Core: optional, maximum of two (2)</li>
<li>Research
Projects: required, minimum of two (2) and maximum of three (3)</li>
</ul>
<div class="heading4">Overall Component</div>
<p>When preparing your application, use Component Type Overall .</p>
<p>All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions, as noted.</p>
<div class="heading4Indent">SF424 (R&R) Cover (Overall)</div>
<p class="P_SingleIndent">Complete entire form. </p>
<div class="heading4Indent">PHS 398 Cover Page Supplement (Overall)</div>
<p class="P_SingleIndent">Note: Human Embryonic Stem Cell
lines from other components should be repeated in cell line table in Overall
component. </p>
<div class="heading4Indent">Research & Related Other
Project Information (Overall)</div>
<p class="P_SingleIndent">Follow standard instructions. </p>
<div class="heading4Indent">Project/Performance Site
Location(s) (Overall)</div>
<p class="P_SingleIndent">Enter primary site only. </p>
<p class="P_SingleIndent"><i>A summary of Project/Performance
Sites in the Overall section of the assembled application image in eRA Commons
compiled from data collected in the other components will be generated upon
submission.</i></p>
<div class="heading4Indent">Research & Related
Senior/Key Person Profile (Overall)</div>
<p class="P_SingleIndent">Include only the Project
Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to
this FOA) for the entire application. </p>
<p class="P_SingleIndent"><i>A summary of Senior/Key Persons
followed by their Biographical Sketches in the Overall section of the assembled
application image in eRA Commons will be generated upon submission.</i></p>
<div class="heading4Indent">Budget (Overall)</div>
<p class="P_SingleIndent">The only budget information
included in the Overall component is the Estimated Project Funding section of
the SF424 (R&R) Cover. </p>
<p class="P_SingleIndent"><i>A budget summary in the Overall
section of the assembled application image in eRA Commons compiled from
detailed budget data collected in the other components will be generated upon
submission.</i></p>
<div class="heading4Indent">PHS 398 Research Plan (Overall)</div>
<p class="P_SingleIndent"><b>Specific Aims: </b>State the overall vision and goals for the Center. The
Specific Aims should be overarching, at a high level, and distinct from the
aims of the individual components. </p>
<p class="P_SingleIndent"><strong><i>This is an
emergency FOA due to the SARS-CoV-2 global pandemic; therefore, applicants do
not need to provide extensive background information or preliminary data in
this application.</i></strong></p>
<p class=P_SingleIndent><b>Research Strategy: </b> In this section, present a concise overall vision and plan for
the proposed SeroNet Center. The vision should focus on the plans for the
funding period of the Research Center and may briefly highlight how the
Research Center will lay the groundwork for longer-term plans. This section
should describe the fundamental question(s) that will be addressed by the
Research Center and how they integrate to form an overall research theme. Items
to be addressed include:</p>
<p class=P_SingleIndent> <strong><em>Research Theme.</em></strong> Define
the overall research theme of the Research Center. Provide a brief background
and rationale for this selection and outline the significance of research in
the selected area.</p>
<ul>
<li> <strong><em>Center
Organization.</em></strong> The Overall component should include a concise
description of the structure of the Center including the organizing framework.
This description should explain: (1) how the components of the Center, including
key personnel, will interact; (2) why each component is essential for
addressing the organizing framework of the Center; and (3) how the organization
of the components into a Center will create an entity that is greater than the
sum of its parts in terms of generating advances in fundamental science of
SARS-CoV-2 serology.</li>
<li> <strong><em>Center Integration</em></strong><i>.</i> Applications should
explicitly discuss the integration of work proposed in the application.
While the Research Projects make up the foundation of the Serology Centers of
Excellence, applicants are encouraged to describe cross-cutting elements in
this Overall component. Applications should demonstrate that use of the
research Center mechanism is essential to accomplishing studies that would not
occur without the climate, facilities, and research resources that a research
Center can uniquely provide.</li>
<li> <strong><em>Center Expertise.</em></strong> The Overall component should
demonstrate that the Center will include the necessary expertise and support
the team science environment needed to complete the proposed research. The
Applications should demonstrate plans for ongoing communication and sharing of
data and resources within the Center.</li>
<li> <strong><em>Research Projects.</em></strong> Briefly describe each
project, including its scientific integration with the proposed organizing
framework and a rationale for how each project will help, within the funded
period, advance research to characterize the responses elicited by SARS-CoV-2
viral infection within the proposed organizing framework.</li>
<li> <strong><em>Shared Resource Cores.</em></strong> Briefly describe any
Shared Resource Cores, including the projects supported by the Core(s), and how
the core(s) will support the projects.</li>
</ul>
<p class=P_SingleIndent><b>Letters of Support: </b>In
addition to standard items, applicants may provide letters from the respective
leadership official(s) in the institution(s) of the proposed center documenting
specific institutional commitments to the proposed center. </p>
<p class=P_SingleIndent><strong>Resource
Sharing Plan:</strong> Individuals are required to comply with the
instructions for the Resource Sharing Plans as provided in the SF424 (R&R)
Application Guide, with the following modification:</p>
<ul>
<li> All applications, regardless of the amount of direct costs
requested for any one year, should address a Resource Sharing Plan. <strong><i>The resource
sharing plan for the Overall component should cover all the activities of the
Center.</i></strong></li>
<li> The Resource Sharing Plan should describe the proposed process for
making the primary data and resulting publications immediately and broadly
available to the public.</li>
<li> The Resource Sharing Plan should also describe approaches for
making protocols, standard operating procedures (SOPs), and computational tools
and other software broadly available. </li>
<li> The Resource Sharing Plan should address sharing of data within a
Center, across the Network, and with the broader research community, </li>
<li> If a clinical trial is planned the Resource Sharing Plan should
address participants' Study Consents and include (whenever possible) the option
to use data and/or biospecimens for future research studies.</li>
<li> Program staff may negotiate modifications to these plans prior to
funding.</li>
</ul>
<p class="P_SingleIndent"><b>Appendix:</b></p>
<p class=P_SingleIndent>Only limited items are allowed in the Appendix.
Follow all instructions for the Appendix as described in the SF424 (R&R)
Application Guide; any instructions provided here are in addition to the SF424
(R&R) Application Guide instructions. </p>
<p class=heading4Indent>PHS Human Subjects and Clinical
Trials Information (Overall)</p>
<p class=P_SingleIndent>When involving human subjects research, clinical
research, and/or NIH-defined clinical trials follow all instructions for the
PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R)
Application Guide, with the following additional instructions:</p>
<p class=P_SingleIndent>If you answered Yes to the question Are Human
Subjects Involved? on the R&R Other Project Information form, there must
be at least one human subjects study record using the<strong> Study Record: PHS Human Subjects and
Clinical Trials Information</strong> form or a <strong>Delayed Onset Study</strong> record within the application. The study record(s) must be included in the
component(s) where the work is being done, unless the same study spans multiple
components. To avoid the creation of duplicate study records, a single study
record with sufficient information for all involved components must be included
in the Overall component when the same study spans multiple components. </p>
<p class=P_SingleIndent><strong>Study
Record: PHS Human Subjects and Clinical Trials Information</strong></p>
<p class="P_SingleIndent">All instructions in the SF424
(R&R) Application Guide must be followed </p>
<p class=P_SingleIndent><strong>Delayed
Onset Study</strong></p>
<p class="P_SingleIndent">Note: <a
href="https://grants.nih.gov/grants/glossary.htm#DelayedOnsetHumanSubjectStudy">Delayed
onset</a> does NOT apply to a study that can be described but will not start
immediately (i.e., delayed start).</p>
<p class="P_SingleIndent">All instructions in the SF424
(R&R) Application Guide must be followed </p>
<div class="heading4Indent">PHS Assignment Request Form (Overall)</div>
<p class="P_SingleIndent">All instructions in the SF424
(R&R) Application Guide must be followed. </p>
<div class="heading4">Administrative Core</div>
<p>When preparing your application, use Component Type Admin Core .</p>
<p>All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions, as noted.</p>
<div class="heading4Indent">SF424 (R&R) Cover (Administrative Core)</div>
<p class="P_SingleIndent">Complete only the following fields:</p>
<ul>
<li> Applicant Information</li>
<li> Type of Applicant (optional)</li>
<li> Descriptive Title of Applicant&rsquo;s Project</li>
<li> Proposed Project Start/Ending Dates</li>
</ul>
<div class="heading4Indent">PHS 398 Cover Page Supplement (Administrative Core)</div>
<p class="P_SingleIndent">Enter Human Embryonic Stem Cells in
each relevant component.</p>
<div class="heading4Indent">Research & Related Other
Project Information (Administrative Core)</div>
<p class="P_SingleIndent"><b>Human Subjects:</b> Answer only
the Are Human Subjects Involved? and 'Is the Project Exempt from Federal
regulations? questions.</p>
<p class="P_SingleIndent"><b>Vertebrate Animals:</b> Answer
only the Are Vertebrate Animals Used? question.</p>
<p class="P_SingleIndent"><b>Project Narrative: </b>Do not
complete. Note: ASSIST screens will show an asterisk for this attachment
indicating it is required. However, eRA systems only enforce this requirement
in the Overall component and applications will not receive an error if omitted
in other components.</p>
<div class="heading4Indent">Project /Performance Site
Location(s) (Administrative Core)</div>
<div class="heading4Indent">List all performance sites that
apply to the specific component.</div>
<p class="P_SingleIndent"><i>Note: The Project Performance
Site form allows up to 300 sites, prior to using additional attachment for
additional entries.</i></p>
<div class="heading4Indent">Research & Related
Senior/Key Person Profile (Administrative Core)</div>
<ul>
<li> In the Project Director/Principal (PD/PI) Investigator section of
the form, use Project Role of Other with Category of Project Lead and
provide a valid eRA Commons ID in the Credential field.</li>
<li> In the additional Senior/Key Profiles section, list Senior/Key
persons that are working in the component.</li>
<li> Include a single Biographical Sketch for each Senior/Key person
listed in the application regardless of the number of components in which they
participate. When a Senior/Key person is listed in multiple components, the
Biographical Sketch can be included in any one component.</li>
<li> If more than 100 Senior/Key persons are included in a component,
the Additional Senior Key Person attachments should be used. </li>
</ul>
<div class="heading4Indent">Budget (Administrative
Core)</div>
<p class="P_SingleIndent">Budget forms
appropriate for the specific component will be included in the application
package.</p>
<ul>
<li> <strong>Center
Administrator:</strong> Based on the
complexity of the Serological Sciences Centers of Excellence, the
Administrative Core Leader is strongly encouraged to propose and budget for a
Center Administrator to manage day-to-day operations.</li>
<li> <strong>Travel
Funds:</strong> The budget should include
funds to support travel for Center and Network activities, including but not
limited to supporting the participation of PD(s)/PI(s) and other Center members
in all SeroNet Investigator Meetings.</li>
<li> <strong>Funds for Trans-Network
Projects:</strong> Beginning in Budget Period 2, applicants
must allocate 10 percent of their annual budget (within
the Direct Costs cap) to a restricted fund to support collaborative
activities with other components of SeroNet. The amount should be presented in
the Other Expenses category under the heading "Collaborative Funds".
Final decisions for the release of set-aside funds will be made by NIH staff based
on recommendations of the SeroNet Steering Committee.</li>
</ul>
<p class="P_SingleIndent"><i>Note: The R&R Budget form
included in many of the component types allows for up to 100 Senior/Key Persons
in section A and 100 Equipment Items in section C prior to using attachments
for additional entries. All other SF424 (R&R) instructions apply.</i></p>
<div class="heading4Indent">PHS 398 Research Plan (Administrative
Core)</div>
<p class="P_SingleIndent"><b>Specific Aims:</b> Outline Specific Aims for the
Administrative Core. </p>
<p class="P_SingleIndent"><b>Research Strategy: </b>In lieu of the standard Research
Strategy sub-sections (Significance, Innovation, Approach), use the
sub-sections defined below to explain how the effective administrative and
organizational capabilities.</p>
<ul type=disc>
<li class="P_SingleIndent"><strong><em>Management and Communication Plan.</em></strong> The
application should describe the plans for management and integration of
Center activities and communication and evaluation of progress across the
Center. The plan should describe the leadership and communication
strategies to manage and track progress of the multiple projects and sites
that make up the Center. The plan should include a description of the
Center leadership structure. Applicants should concisely describe
oversight mechanisms that will be used by the Center PD(s)/PI(s). </li>
</ul>
<ul type=disc>
<li class="P_SingleIndent"><strong><em>SeroNet Meetings and Other Network Activities.</em></strong> Provide
a brief description of strategies for connecting and integrating the
Center with the broader SeroNet. Funded Centers are expected to
participate in SeroNet Investigators meetings to present results and to
communicate with other Network investigators. The Center PD(s)/PI(s) are
expected to attend the Investigator Meetings and participating faculty,
postdoctoral associates, graduate students, and other Center members are
all encouraged to attend. Center Investigators are also encouraged to
organize and participate in other Network meetings and workshops, organize
collaborative activities, promote Trans-Network collaborations, and share
data through the SSNCC.</li>
</ul>
<ul type=disc>
<li class="P_SingleIndent"><strong><em>Center and Program Evaluation.</em></strong> The
Administrative Core should coordinate participation in Center program
evaluation activities, including progress reports, site visits, and
providing additional communication and materials to NIH as needed.</li>
</ul>
<ul type=disc>
<li class="P_SingleIndent"> </li>
</ul>
<p class="P_SingleIndent"><b>Letters of Support: </b>In addition to standard items,
applicants may provide letters from the respective leadership official(s) in
the institution(s) of the proposed center documenting specific institutional
commitments to the proposed center. </p>
<p class=P_SingleIndent><b>Resource Sharing Plan:</b> Individuals are
required to comply with the instructions for the Resource Sharing Plans as
provided in the SF424 (R&R) Application Guide, with the following
modification:</p>
<p class=P_SingleIndent><strong><em>Resource Sharing Plans should only be
included in the Overall component. Individual components will adhere to the
overarching Resource Sharing Plan.</em></strong></p>
<p class="P_SingleIndent"><b>Appendix:</b> </p>
<p class=P_SingleIndent>Only limited items are allowed in the Appendix.
Follow all instructions for the Appendix as described in the SF424 (R&R)
Application Guide; any instructions provided here are in addition to the SF424
(R&R) Application Guide instructions.</p>
<div class="P_SingleIndent"> </div>
<div class="heading4Indent">PHS Human Subjects and Clinical Trials Information (Administrative Core)</div>
<p class=P_SingleIndent>When involving human subjects research, clinical
research, and/or NIH-defined clinical trials follow all instructions for the
PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R)
Application Guide, with the following additional instructions:</p>
<p class=P_SingleIndent>If you answered Yes to the question Are Human
Subjects Involved? on the R&R Other Project Information form, you must
include at least one human subjects study record using the <strong>Study Record: PHS Human Subjects and
Clinical Trials Information</strong> form or a <strong>Delayed Onset Study</strong> record.</p>
<p class=P_SingleIndent><strong>Study
Record: PHS Human Subjects and Clinical Trials Information</strong></p>
<p class="P_SingleIndent">All instructions in the SF424
(R&R) Application Guide must be followed </p>
<p class=P_SingleIndent><strong>Delayed
Onset Study</strong></p>
<p class="P_SingleIndent">Note: <a
href="https://grants.nih.gov/grants/glossary.htm#DelayedOnsetHumanSubjectStudy">Delayed
onset</a> does NOT apply to a study that can be described but will not start
immediately (i.e., delayed start).All instructions in the SF424 (R&R)
Application Guide must be followed</p>
<div class="heading4"> </div>
<p class=heading4>Shared
Resource Core</p>
<p>When preparing your application, use Component Type Core .</p>
<p>All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions, as noted.</p>
<div class="heading4Indent">SF424 (R&R) Cover (Shared Resource Core)</div>
<p class="P_SingleIndent">Complete only the following fields:</p>
<ul>
<li> Applicant Information</li>
<li> Type of Applicant (optional)</li>
<li> Descriptive Title of Applicant&rsquo;s Project</li>
<li> Proposed Project Start/Ending Dates</li>
</ul>
<div class="heading4Indent">PHS 398 Cover Page Supplement (Shared Resource Core)</div>
<p class="P_SingleIndent">Enter Human Embryonic Stem Cells in
each relevant component.</p>
<div class="heading4Indent">Research & Related Other
Project Information (Shared Resource Core)</div>
<p class="P_SingleIndent"><b>Human Subjects:</b> Answer only
the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations?
questions.</p>
<p class="P_SingleIndent"><b>Vertebrate Animals:</b> Answer
only the Are Vertebrate Animals Used? question.</p>
<p class="P_SingleIndent"><b>Project Narrative: </b>Do not
complete. Note: ASSIST screens will show an asterisk for this attachment
indicating it is required. However, eRA systems only enforce this requirement
in the Overall component and applications will not receive an error if omitted
in other components.</p>
<div class="heading4Indent">Project /Performance Site
Location(s) (Shared Resource Core)</div>
<div class="heading4Indent">List all performance sites that
apply to the specific component.</div>
<p class="P_SingleIndent"><i>Note: The Project Performance
Site form allows up to 300 sites, prior to using additional attachment for
additional entries.</i></p>
<div class="heading4Indent">Research & Related
Senior/Key Person Profile (Shared Resource Core)</div>
<ul>
<li> In the Project Director/Principal Investigator section of the form,
use Project Role of Other with Category of Project Lead and provide a valid
eRA Commons ID in the Credential field.</li>
<li> In the additional Senior/Key Profiles section, list Senior/Key
persons that are working in the component.</li>
<li> Include a single Biographical Sketch for each Senior/Key person
listed in the application regardless of the number of components in which they
participate. When a Senior/Key person is listed in multiple components, the
Biographical Sketch can be included in any one component.</li>
<li> If more than 100 Senior/Key persons are included in a component,
the Additional Senior Key Person attachments should be used. </li>
</ul>
<div class="heading4Indent">Budget (Shared Resource
Core)</div>
<p class="P_SingleIndent">Budget forms
appropriate for the specific component will be included in the application package.</p>
<p class="P_SingleIndent"><i>Note: The R&R Budget form
included in many of the component types allows for up to 100 Senior/Key Persons
in section A and 100 Equipment Items in section C prior to using attachments
for additional entries. All other SF424 (R&R) instructions apply.</i></p>
<div class="heading4Indent">PHS 398 Research Plan (Shared
Resource Core)</div>
<p class="P_SingleIndent"><b>Specific Aims:</b> In addition to outlining the specific
aims of the Shared Resource Core, list which projects will be supported by the
Shared Resource Core.</p>
<div class="P_SingleIndent"><strong>Research Strategy:</strong> The
Shared Resource Cores may be physical or virtual infrastructures (e.g. imaging,
or cloud-based computing or storage) providing a biological, pathological,
computational or engineering resource that supports other Center components in
their activities. Each Shared Resource Core is expected to support at least two
Research Projects and the services and resources provided to other Research
Center components should be clearly defined. Issues to be addressed include,
but are not limited to:</div>
<ul>
<li> Value of the Core services to the Research Center and Research
Projects;</li>
<li> Interactions between the Core and Research Projects;</li>
<li> Procedures for how the core prioritizes services to the proposed
projects in the U54 Center, including allocating resources, cost effectiveness,
and increased efficiency; and</li>
<li> Quality control measures.</li>
</ul>
<p class=P_SingleIndent>Any proposed new shared resources
must not duplicate analogous resources already established in the applicant
institutions. If existing cores and resources are to be used, then funding to
augment such existing resources may be requested. Description of how work
related to the Center will be prioritized within such a core must be provided.</p>
<p class="P_SingleIndent"><b>Letters of Support: </b>In addition to standard items,
applicants may provide letters from the respective leadership official(s) in the
institution(s) of the proposed center documenting specific institutional
commitments to the proposed center. </p>
<p class=P_SingleIndent><b>Resource Sharing Plan:</b> Individuals are
required to comply with the instructions for the Resource Sharing Plans as
provided in the SF424 (R&R) Application Guide, with the following
modification:</p>
<p class=P_SingleIndent><strong><em>Resource Sharing
Plans should only be included in the Overall component. Individual components
will adhere to the overarching Resource Sharing Plan.</em></strong></p>
<p class="P_SingleIndent"><b>Appendix:</b> </p>
<p class=P_SingleIndent>Only limited items are allowed in the Appendix. Follow
all instructions for the Appendix as described in the SF424 (R&R)
Application Guide; any instructions provided here are in addition to the SF424
(R&R) Application Guide instructions.</p>
<div class="P_SingleIndent"> </div>
<div class="heading4Indent">PHS Human Subjects and Clinical Trials Information (Shared Resource Core)</div>
<p class=P_SingleIndent>When involving human subjects research, clinical
research, and/or NIH-defined clinical trials follow all instructions for the
PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R)
Application Guide, with the following additional instructions:</p>
<p class=P_SingleIndent>If you answered Yes to the question Are Human
Subjects Involved? on the R&R Other Project Information form, you must
include at least one human subjects study record using the <strong>Study Record: PHS Human Subjects and
Clinical Trials Information</strong> form or a <strong>Delayed Onset Study</strong> record.</p>
<p class=P_SingleIndent><strong>Study
Record: PHS Human Subjects and Clinical Trials Information</strong></p>
<p class="P_SingleIndent">All instructions in the SF424
(R&R) Application Guide must be followed </p>
<p class=P_SingleIndent><strong>Delayed
Onset Study</strong></p>
<p class="P_SingleIndent">Note: <a
href="https://grants.nih.gov/grants/glossary.htm#DelayedOnsetHumanSubjectStudy">Delayed
onset</a> does NOT apply to a study that can be described but will not start
immediately (i.e., delayed start).All instructions in the SF424 (R&R)
Application Guide must be followed </p>
<div class="heading4Indent">Research Projects</div>
<p class="P_SingleIndent">When preparing your application, use Component Type Project .</p>
<p class="P_SingleIndent">All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions, as noted.</p>
<div class="heading4">SF424 (R&R) Cover (Research Projects)</div>
<p>Complete only the following fields:</p>
<ul>
<li> Applicant Information</li>
<li> Type of Applicant (optional)</li>
<li> Descriptive Title of Applicant&rsquo;s Project starting
with <b>"Project 1:"</b>,<b> "Project 2:"</b>,
etc.</li>
<li> Proposed Project Start/Ending Dates</li>
</ul>
<div class="heading4Indent">PHS 398 Cover Page Supplement (Research Projects)</div>
<p class="P_SingleIndent">Enter Human Embryonic Stem Cells in
each relevant component.</p>
<div class="heading4Indent">Research & Related Other
Project Information (Research Projects)</div>
<p class="P_SingleIndent"><b>Human Subjects:</b> Answer only
the Are Human Subjects Involved? and 'Is the Project Exempt from Federal
regulations? questions.</p>
<p class="P_SingleIndent"><b>Vertebrate Animals:</b> Answer
only the Are Vertebrate Animals Used? question.</p>
<p class="P_SingleIndent"><b>Project Narrative: </b>Do not
complete. Note: ASSIST screens will show an asterisk for this attachment
indicating it is required. However, eRA systems only enforce this requirement
in the Overall component and applications will not receive an error if omitted
in other components.</p>
<div class="heading4Indent">Project /Performance Site
Location(s) (Research Projects)</div>
<div class="heading4Indent">List all performance sites that
apply to the specific component.</div>
<p class="P_SingleIndent"><i>Note: The Project Performance
Site form allows up to 300 sites, prior to using additional attachment for
additional entries.</i></p>
<div class="heading4Indent">Research & Related
Senior/Key Person Profile (Research Projects)</div>
<ul>
<li> In the Project Director/Principal Investigator section of the
form, use Project Role of Other with Category of Project Lead and provide a
valid eRA Commons ID in the Credential field.</li>
<li> In the additional Senior/Key Profiles section, list Senior/Key
persons that are working in the component.</li>
<li> Include a single Biographical Sketch for each Senior/Key person
listed in the application regardless of the number of components in which they
participate. When a Senior/Key person is listed in multiple components, the
Biographical Sketch can be included in any one component.</li>
<li> If more than 100 Senior/Key persons are included in a component,
the Additional Senior Key Person attachments should be used. </li>
</ul>
<div class="heading4Indent">Budget (Research Projects)</div>
<p class="P_SingleIndent">Budget forms appropriate for the
specific component will be included in the application package. </p>
<p class="P_SingleIndent"><i>Note: The R&R Budget form
included in many of the component types allows for up to 100 Senior/Key Persons
in section A and 100 Equipment Items in section C prior to using attachments
for additional entries. All other SF424 (R&R) instructions apply.</i></p>
<div class="heading4Indent">PHS 398 Research Plan (Research
Projects)</div>
<p class="P_SingleIndent"><b>Specific Aims:</b> State the specific aims of the Research Project and provide a
rationale and description of how they fit into the overall research theme of
the Research Center. </p>
<p class="P_SingleIndent"><b>Research Strategy: </b>Applicants should use the standard structure of the Research
Strategy section (i.e., sub-sections <i>Significance, Innovation, and
Approach</i>). </p>
<p class="P_SingleIndent"><strong><i>This is an
emergency FOA due to the SARS-CoV-2 global pandemic; therefore, applicants do
not need to provide extensive background information or preliminary data in
this application.</i></strong></p>
<p class="P_SingleIndent">Clearly describe the
SARS-CoV-2 serological science research addressed by each Project. Explain
how the proposed research will accelerate
understanding the immune response to SARS-CoV-2 and
inform the development of novel serological tests to further define the
characteristics of COVID-19. If
applicable, describe how the shared resource(s) will be used for the proposed
research. </p>
<p class=P_SingleIndent><b>Resource Sharing Plan:</b> Individuals are
required to comply with the instructions for the Resource Sharing Plans as
provided in the SF424 (R&R) Application Guide, with the following
modification:</p>
<p class=P_SingleIndent>All applications, regardless of the amount of direct
costs requested for any one year, should address a Data Sharing Plan.</p>
<p class=P_SingleIndent><strong><em>Resource Sharing
Plans should only be included in the Overall component. Individual components
will adhere to the overarching Resource Sharing Plan.</em></strong></p>
<p class="P_SingleIndent"><b>Appendix:</b> </p>
<p class=P_SingleIndent>Only limited items are allowed in the Appendix. Follow
all instructions for the Appendix as described in the SF424 (R&R)
Application Guide; any instructions provided here are in addition to the SF424
(R&R) Application Guide instructions. </p>
<div class="heading4"> </div>
<div class="heading4Indent">PHS Human Subjects and Clinical Trials Information (Research Projects)</div>
<p class=P_SingleIndent>When involving human subjects research, clinical
research, and/or NIH-defined clinical trials follow all instructions for the
PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application
Guide, with the following additional instructions:</p>
<p class=P_SingleIndent>If you answered Yes to the question Are Human
Subjects Involved? on the R&R Other Project Information form, you must
include at least one human subjects study record using the <strong>Study Record: PHS Human Subjects and
Clinical Trials Information</strong><strong> </strong>form or a <strong>Delayed Onset Study</strong> record.</p>
<p class=P_SingleIndent><strong>Study
Record: PHS Human Subjects and Clinical Trials Information</strong></p>
<p class="P_SingleIndent">All instructions in the SF424
(R&R) Application Guide must be followed </p>
<p class=P_SingleIndent><strong>Delayed
Onset Study</strong></p>
<p class="P_SingleIndent">Note: <a
href="https://grants.nih.gov/grants/glossary.htm#DelayedOnsetHumanSubjectStudy">Delayed
onset</a> does NOT apply to a study that can be described but will not start
immediately (i.e., delayed start).All instructions in the SF424 (R&R)
Application Guide must be followed </p>
<div class="heading3">3. Unique Entity Identifier
and System for Award Management (SAM)</div>
<p>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><a href="#_Part_1._Overview">Part I. Overview Information</a> contains information about Key Dates and times. Applicants are encouraged to
submit 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://grants.nih.gov/grants/guide/url_redirect.htm?id=82380">Federal
holiday</a>, the application deadline is automatically extended to the next
business day.</p>
<p>Organizations must submit applications to <a
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11128"
target="_blank">Grants.gov</a> (the online portal to find and apply for grants
across all Federal agencies) using ASSIST or other electronic submission
systems. Applicants must then complete the submission process by tracking the
status of the application in the <a
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11123"
target="_blank">eRA Commons</a>, NIH&rsquo;s electronic system for grants
administration. NIH and Grants.gov systems check the application against many
of the application instructions upon submission. Errors must be corrected and a
changed/corrected application must be submitted to Grants.gov on or before the
application due date and time. If a Changed/Corrected application is submitted
after the deadline, the application will be considered late. Applications that
miss the due date and time are subjected to the NIH Policy on Late Application
Submission. </p>
<p><strong>Applicants
are responsible for viewing their application before the due date in the eRA Commons
to ensure accurate and successful submission. </strong></p>
<p>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>This initiative is not subject to <a
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11142">intergovernmental
review.</a> </p>
<div class="heading3"><a name="_5._Funding_Restrictions"></a>6. Funding Restrictions</div>
<p>All NIH awards are subject to the terms and conditions, cost
principles, and other considerations described in the <a
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11120"><i>NIH
Grants Policy Statement</i></a>. </p>
<p>Pre-award costs are allowable only as described in the <a
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11143"><i>NIH
Grants Policy Statement</i></a>.</p>
<p>Pre-award
costs may be incurred from January 20, 2020 through the public health emergency
period and prior to the date of the federal award.</p>
<div class="heading3">7. Other Submission
Requirements and Information</div>
<p>Applications must be submitted electronically following the
instructions described in the SF424 (R&R) Application Guide. Paper
applications will not be accepted. </p>
<p>For information on how your application will be
automatically assembled for review and funding consideration after submission
go to: <a
href="//grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf">http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf</a>. </p>
<p><b>Applicants must complete all required registrations
before the application due date.</b> <span class=P_SingleIndent><a href="#_Section_III._Eligibility">Section
III. Eligibility Information</a></span> contains information about registration.</p>
<p>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 <a
href="#_Section_VII._Agency">Section VII</a>.</p>
<p><strong>Important reminders:</strong></p>
<p>All PD(s)/PI(s) and component
Project Leads must include their eRA Commons ID in the Credential field<b> </b>of
the Senior/Key Person Profile Component of the SF424(R&R) Application
Package<b>. </b>Failure to register in the 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>The applicant organization must
ensure that the DUNS number it provides on the application is the same number
used in the organization&rsquo;s profile in the eRA Commons and for the System for
Award Management (SAM). Additional information may be found in the SF424
(R&R) Application Guide.</p>
<p>See <a
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11146">more tips</a> for avoiding common errors. </p>
<p>Upon receipt, applications will be evaluated for
completeness and compliance with application
instructions by the Center for Scientific Review and responsiveness by <a
href="#_Components_of_Participating">components of participating organizations</a>,
NIH. Applications that are incomplete,
non-compliant and/or nonresponsive will not be reviewed.</p>
<div class="heading4">Post Submission Materials</div>
<p>Applicants are required to follow the instructions for
post-submission materials, as described in <a
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=82299">the policy</a>. Any instructions
provided here are in addition to the instructions in the policy.</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>Only the review criteria described below will be considered
in the review process. Applications submitted to the NIH in support of the <a
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11149">NIH mission</a> are evaluated for scientific and technical merit through the NIH peer review
system.</p>
<p><b>For this FOA, note the following:</b></p>
<ul>
<li> <i>This is an emergency FOA due to </i><i>the </i><i>SARS-CoV-2</i><i> global
pandemic; therefore, applicants do not need to provide extensive background
information or preliminary data in this application.</i></li>
<li> Accordingly, reviewers will emphasize the conceptual framework,
the level of innovation, and the potential to significantly advance our
knowledge or understanding. Appropriate justification for the proposed work can
be provided through literature citations, data from other sources, or, when
available, from investigator-generated data. Applications with a cancer
component will be given preference.</li>
</ul>
<p><b>In addition, for applications involving clinical trials:</b> A proposed Clinical Trial application may include study design, methods, and
intervention that are not necessarily innovative but nevertheless address
important questions or unmet needs. The results of the clinical trial may
indicate that further development of the intervention is unwarranted or lead to
new avenues of scientific investigation.</p>
<div class="heading4">Overall Impact - Overall</div>
<p>Reviewers will provide an overall impact score to reflect
their assessment of the likelihood for the project to exert a sustained,
powerful influence on the research field(s) involved, in consideration of the
following review criteria and additional review criteria (as applicable for the
project proposed).</p>
<div class="heading4"><a name="scored_1"></a>Scored Review Criteria - Overall</div>
<p>Reviewers will consider each of the review criteria below in
the determination of scientific merit and give a separate score for each. An
application does not need to be strong in all categories to be judged likely to
have major scientific impact. For example, a project that by its nature is not
innovative may be essential to advance a field.</p>
<div class="heading4Indent">Significance</div>
<p class="P_SingleIndent">Does the project address an
important problem or a critical barrier to progress in the field? Is the prior
research that serves as the key support for the proposed project rigorous? If
the aims of the project are achieved, how will scientific knowledge, technical
capability, and/or clinical practice be improved? How will successful
completion of the aims change the concepts, methods, technologies, treatments,
services, or preventative interventions that drive this field? </p>
<p class="P_SingleIndent"><strong>Specific to this FOA:</strong> How well does the project propose
to identify and advance research to characterize the adaptive and innate immune
responses to SARS-CoV-2 leading to the development and implementation of
serologic testing? If appropriate, to what extent does the proposed
project consider the interaction between the SARS-CoV-2 immune response and
cancer? </p>
<p class=P_SingleIndent><strong>In
addition, for applications involving clinical trials</strong></p>
<p class="P_SingleIndent">Are the scientific rationale and
need for a clinical trial to test the proposed hypothesis or intervention well supported
by preliminary data, clinical and/or preclinical studies, or information in the
literature or knowledge of biological mechanisms? For trials focusing on
clinical or public health endpoints, is this clinical trial necessary for
testing the safety, efficacy or effectiveness of an intervention that could
lead to a change in clinical practice, community behaviors or health care
policy? For trials focusing on mechanistic, behavioral, physiological,
biochemical, or other biomedical endpoints, is the trial needed to advance
scientific understanding?</p>
<div class="heading4Indent"><a name="scored_2"></a>Investigator(s)</div>
<p class="P_SingleIndent">Are the PD(s)/PI(s), collaborators,
and other researchers well suited to the project? If Early Stage Investigators
or those in the early stages of independent careers, do they have appropriate experience
and training? If established, have they demonstrated an ongoing record of
accomplishments that have advanced their field(s)? If the project is
collaborative or multi-PD/PI, do the investigators have complementary and
integrated expertise; are their leadership approach, governance and
organizational structure appropriate for the project? </p>
<p class="P_SingleIndent"><strong>Specific to this FOA:</strong> Are the backgrounds, expertise, and
commitments of the PD(s)/PI(s) and other key persons in line with the overall
goals of Serological Sciences Centers of Excellence? For applications involving multiple
PDs/PIs, are their designated roles and responsibilities well defined,
adequate, and complementary for achieving the goals of the proposed Research
Center? How well do the proposed collaborations among the Serological
Sciences Centers of Excellence PD(s)/PI(s) and other key persons integrate to achieve the overarching research
goals? Have the investigators
demonstrated ongoing records of collaboration?</p>
<p class=P_SingleIndent><strong>In
addition, for applications involving clinical trials</strong></p>
<p class=P_SingleIndent>With regard to the proposed leadership for the
project, do the PD/PI(s) and key personnel have the expertise, experience, and
ability to organize, manage and implement the proposed clinical trial and meet
milestones and timelines? Do they have appropriate expertise in study
coordination, data management and statistics? For a multicenter trial, is the
organizational structure appropriate and does the application identify a core
of potential center investigators and staffing for a coordinating center?</p>
<div class="heading4Indent"><a name="scored_3"></a>Innovation</div>
<p class="P_DoubleIndent">Does the application challenge and
seek to shift current research or clinical practice paradigms by utilizing
novel theoretical concepts, approaches or methodologies, instrumentation, or
interventions? Are the concepts, approaches or methodologies, instrumentation,
or interventions novel to one field of research or novel in a broad sense? Is a
refinement, improvement, or new application of theoretical concepts, approaches
or methodologies, instrumentation, or interventions proposed? </p>
<p class="P_DoubleIndent"><strong>Specific to this FOA: </strong>To what extent does
this application propose approaches to increase the understanding of SARS-CoV-2
immune responses and the underlying mechanisms that will inform the development
of novel serologic tests, or the clinical and public health implementation of
validated serologic assays? </p>
<p class=P_SingleIndent><strong>In
addition, for applications involving clinical trials</strong></p>
<p class=P_SingleIndent>Does the design/research plan include innovative
elements, as appropriate, that enhance its sensitivity, potential for
information or potential to advance scientific knowledge or clinical practice?</p>
<div class="heading4Indent"><a name="scored_4"></a>Approach</div>
<p class="P_SingleIndent">Are the overall strategy,
methodology, and analyses well-reasoned and appropriate to accomplish the
specific aims of the project? Have investigators included plans to address
weaknesses in the rigor of prior research that serves as the key support for
the proposed project? Have the investigators presented strategies to ensure a
robust and unbiased approach, as appropriate for the work proposed? Are potential
problems, alternative strategies, and benchmarks for success presented? If the
project is in the early stages of development, will the strategy establish
feasibility and will particularly risky aspects be managed? Have the
investigators presented adequate plans to address relevant biological
variables, such as sex, for studies in vertebrate animals or human subjects?</p>
<p class="P_SingleIndent">If the project involves human
subjects and/or NIH-defined clinical research, are the plans to address:</p>
<p class="P_SingleIndent"> 1) the protection of human subjects
from research risks, and </p>
<p class="P_SingleIndent"> 2) 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), justified in terms of the scientific goals and research strategy
proposed? </p>
<p class=P_SingleIndent><strong>In
addition, for applications involving clinical trials</strong></p>
<p class=P_SingleIndent>Does the application adequately address the
following, if applicable:</p>
<p class=P_SingleIndent><em>Study
Design </em></p>
<p class=P_SingleIndent>Is the study design justified and appropriate to
address primary and secondary outcome variable(s)/endpoints that will be clear,
informative and relevant to the hypothesis being tested? Is the scientific
rationale/premise of the study based on previously well-designed preclinical
and/or clinical research? Given the methods used to assign participants and
deliver interventions, is the study design adequately powered to answer the
research question(s), test the proposed hypothesis/hypotheses, and provide interpretable
results? Is the trial appropriately designed to conduct the research
efficiently? Are the study populations (size, gender, age, demographic group),
proposed intervention arms/dose, and duration of the trial, appropriate and
well justified? </p>
<p class=P_SingleIndent>Are potential ethical issues adequately addressed? Is
the process for obtaining informed consent or assent appropriate? Is the
eligible population available? Are the plans for recruitment outreach,
enrollment, retention, handling dropouts, missed visits, and losses to
follow-up appropriate to ensure robust data collection? Are the planned
recruitment timelines feasible and is the plan to monitor accrual adequate? Has
the need for randomization (or not), masking (if appropriate), controls, and
inclusion/exclusion criteria been addressed? Are differences addressed, if
applicable, in the intervention effect due to sex/gender and race/ethnicity? </p>
<p class=P_SingleIndent>Are the plans to standardize, assure quality of, and
monitor adherence to, the trial protocol and data collection or distribution
guidelines appropriate? Is there a plan to obtain required study agent(s)? Does
the application propose to use existing available resources, as applicable? </p>
<p class=P_SingleIndent><em>Data
Management and Statistical Analysis </em></p>
<p class="P_SingleIndent">Are planned analyses and statistical
approach appropriate for the proposed study design and methods used to assign
participants and deliver interventions? Are the procedures for data management
and quality control of data adequate at clinical site(s) or at center
laboratories, as applicable? Have the methods for standardization of procedures
for data management to assess the effect of the intervention and quality
control been addressed? Is there a plan to complete data analysis within the
proposed period of the award?</p>
<div class="heading4Indent"><a name="scored_5"></a>Environment</div>
<p class="P_SingleIndent">Will the scientific environment in
which the work will be done contribute to the probability of success? Are the
institutional support, equipment and other physical resources available to the
investigators adequate for the project proposed? Will the project benefit from
unique features of the scientific environment, subject populations, or
collaborative arrangements? </p>
<p class=P_SingleIndent><strong>In
addition, for applications involving clinical trials</strong></p>
<p class=P_SingleIndent>If proposed, are the administrative, data
coordinating, enrollment and laboratory/testing centers, appropriate for the
trial proposed? </p>
<p class=P_SingleIndent>Does the application adequately address the
capability and ability to conduct the trial at the proposed site(s) or centers?
Are the plans to add or drop enrollment centers, as needed, appropriate? </p>
<p class=P_SingleIndent>If international site(s) is/are proposed, does the
application adequately address the complexity of executing the clinical trial?</p>
<p class=P_SingleIndent>If multi-sites/centers, is there evidence of the
ability of the individual site or center to: (1) enroll the proposed numbers;
(2) adhere to the protocol; (3) collect and transmit data in an accurate and
timely fashion; and, (4) operate within the proposed organizational structure?</p>
<div class="heading4">Additional Review Criteria - Overall</div>
<p>As applicable for the project proposed, reviewers will evaluate
the following additional items while determining scientific and technical
merit, and in providing an overall impact score, but will not give separate
scores for these items.</p>
<div class="heading4Indent">Research Projects</div>
<p class="P_SingleIndent">How well do the proposed research projects address topics
that are high priority to SARS-CoV-2 serological science research? Does the
application identify a major research theme and are the proposed research
projects linked to the theme? For each project, are the strategy, methodology,
and analyses well-reasoned and appropriate to accomplish the specific aims of
the research project? Are potential problems, alternative strategies, and
benchmarks for success presented? How will the scientific knowledge gained from
the proposed research projects accelerate understanding the immune response and
inform the development of novel serological tests to further define the
characteristics of COVID-19?</p>
<div class="heading4Indent">Shared Resource Core</div>
<p class="P_SingleIndent">How well is the proposed Shared Resource Core matched to the
needs of the research being proposed? What is the overall quality of the
proposed core services? Are adequate quality control processes proposed for the
facilities or services provided by the Shared Resource Cores (including
procedures, techniques, and quality control)? What are the criteria for
prioritization and usage of Core products and/or services? Are the
qualifications, experience, and commitment of the Shared Resource Core Lead(s)
and other key personnel adequate and appropriate for providing the proposed
facilities or services? Will the proposed shared resource core(s) provide cost
effective services? Is the environment for the shared resource core adequate to
support the program as proposed?</p>
<div class="heading4Indent">Administrative/Coordinating Core</div>
<p class="P_SingleIndent">Is
the proposed Administrative Core well matched to the needs of the Center? Is
the management proposed appropriate for scientific administration as well as
fiscal administration, procurement, and personnel management? Is its role in
the Center clearly defined? If appropriate, how well do the proposed activities
for strengthening research administration address the needs of the Center?</p>
<p class=P_SingleIndent>Study Timeline </p>
<p class=P_SingleIndent><strong>Specific
to applications involving clinical trials</strong></p>
<p class=P_SingleIndent>Is the study timeline described in detail, taking
into account start-up activities, the anticipated rate of enrollment, and
planned follow-up assessment? Is the projected timeline feasible and well
justified? Does the project incorporate efficiencies and utilize existing
resources (e.g., CTSAs, practice-based research networks, electronic medical
records, administrative database, or patient registries) to increase the
efficiency of participant enrollment and data collection, as appropriate? </p>
<p class=P_SingleIndent>Are potential challenges and corresponding solutions
discussed (e.g., strategies that can be implemented in the event of enrollment
shortfalls?</p>
<div class="heading4Indent"><a name=humans></a>Protections
for Human Subjects</div>
<p class="P_SingleIndent">For research that involves human
subjects but does not involve one of the categories of research that are exempt
under 45 CFR Part 46, the committee 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="P_SingleIndent">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, the committee 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.htm?id=11175">Guidelines
for the Review of Human Subjects</a>.</p>
<div class="heading4Indent"><a name=inclusion></a>Inclusion
of Women, Minorities, and Individuals Across the Lifespan </div>
<p class="P_SingleIndent">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. For additional information on review of the Inclusion
section, please refer to the <a
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11174">Guidelines
for the Review of Inclusion in Clinical Research</a>.</p>
<div class="heading4Indent"><a name=animals></a>Vertebrate
Animals</div>
<p class="P_SingleIndent">The committee will evaluate the
involvement of live vertebrate animals as part of the scientific assessment
according to the following criteria: (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.htm?id=11150">Worksheet
for Review of the Vertebrate Animal Section</a>.</p>
<div class="heading4Indent"><a name=biohazards></a>Biohazards</div>
<p class="P_SingleIndent">Reviewers 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="heading4Indent"><a name=resubmissions></a>Resubmissions</div>
<p class="P_SingleIndent">Not Applicable </p>
<div class="heading4Indent"><a name=renewals></a>Renewals</div>
<p class="P_SingleIndent"> Not Applicable</p>
<div class="heading4Indent"><a name=revisions></a>Revisions</div>
<p class="P_SingleIndent">Not Applicable</p>
<div class="heading4">Additional Review Considerations - Overall</div>
<p class="P_SingleIndent">As applicable for the project proposed, reviewers will
consider each of the following items, but will not give scores for these items,
and should not consider them in providing an overall impact score.</p>
<div class="heading4Indent"><a name=foreign></a>Applications
from Foreign Organizations</div>
<p class="P_SingleIndent">Not Applicable</p>
<div class="heading4Indent"><a name=agents></a>Select Agent
Research</div>
<p class="P_SingleIndent">Reviewers will assess the information
provided in this section of the application, including 1) the Select Agent(s)
to be used in the proposed research, 2) the registration status of all entities
where Select Agent(s) will be used, 3) the procedures that will be used to
monitor possession use and transfer of Select Agent(s), and 4) plans for
appropriate biosafety, biocontainment, and security of the Select Agent(s).</p>
<div class="heading4Indent"><a name=sharing></a>Resource
Sharing Plans</div>
<p class="P_SingleIndent">Reviewers will comment on whether
the following Resource Sharing Plans, or the rationale for not sharing the
following types of resources, are reasonable: 1) <a
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11151">Data
Sharing Plan</a>; 2) <a
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11152">Sharing
Model Organisms</a>; and 3) <a
href="//grants.nih.gov/grants/guide/notice-files/NOT-OD-14-124.html">Genomic
Data Sharing Plan</a> .</p>
<div class="heading4Indent"><br>
<a name=authentication></a>Authentication of Key Biological
and/or Chemical Resources</div>
<p class="P_SingleIndent">For projects involving key
biological and/or chemical resources, reviewers will comment on the brief plans
proposed for identifying and ensuring the validity of those resources.</p>
<div class="heading4Indent"><a name=budget></a>Budget and
Period of Support</div>
<p class="P_SingleIndent">Reviewers will consider whether the
budget and the requested period of support are fully justified and reasonable
in relation to the proposed research.</p>
<div class="heading3">2. Review and Selection
Process </div>
<p>Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group(s), convened by the NCI in
accordance with <a
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11154">NIH peer
review policy and procedures</a>, using the stated <a href="#_1._Criteria">review
criteria</a>. Assignment to a Scientific Review Group will be shown in the eRA
Commons. </p>
<p>As part of the scientific peer review, all applications:</p>
<ul>
<li> May undergo a selection process in which only those applications
deemed to have the highest scientific and technical merit (generally the top
half of applications under review) will be discussed and assigned an overall
impact score. </li>
<li> Will receive a written critique.</li>
</ul>
<p><a
href="//grants.nih.gov/grants/guide/notice-files/NOT-OD-11-064.html">Appeals</a> of initial peer review will not be accepted for applications submitted in
response to this FOA.</p>
<p>Applications will be assigned on the basis of established
PHS referral guidelines to the appropriate NIH Institute or Center.
Applications will compete for available funds with all other recommended
applications submitted in response to this FOA. Following initial peer review,
recommended applications will receive a second level of review by the
appropriate national Advisory Council or Board. The following will be
considered in making funding decisions: </p>
<ul>
<li> Scientific and technical merit of the proposed project as
determined by scientific peer review. </li>
<li> Availability of funds. </li>
<li> Relevance of the proposed project to program priorities. </li>
</ul>
<div class="heading3"><a name="_3._Anticipated_Announcement"></a>3. Anticipated Announcement and Award Dates</div>
<p>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>If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the <a
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11157"><i>NIH
Grants Policy Statement</i></a>. </p>
<p>A formal notification in the form of a Notice of Award (NoA)
will be provided to the applicant organization for successful applications. The
NoA signed by the grants management officer is the authorizing document and
will be sent via email to the grantee&rsquo;s business official. </p>
<p>Awardees 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>Any application awarded in response to this FOA will be
subject to terms and conditions found on the <a
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11158">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.</p>
<p>Individual awards are based on the application submitted to,
and as approved by, the NIH and are subject to the IC-specific terms and
conditions identified in the NoA.</p>
<p>ClinicalTrials.gov: If an award provides for one or more
clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the
"responsible party" must register and submit results information for
certain applicable clinical trials on the ClinicalTrials.gov Protocol
Registration and Results System Information Website (<a
href="https://register.clinicaltrials.gov">https://register.clinicaltrials.gov</a>).
NIH expects registration and results reporting of all trials whether required
under the law or not. For more information, see <a
href="https://grants.nih.gov/policy/clinical-trials/reporting/index.htm">https://grants.nih.gov/policy/clinical-trials/reporting/index.htm</a> </p>
<p>Institutional Review Board or Independent Ethics Committee
Approval: Grantee institutions must ensure that all protocols are reviewed by
their IRB or IEC. To help ensure the safety of participants enrolled in
NIH-funded studies, the awardee must provide NIH copies of documents related to
all major changes in the status of ongoing protocols. Data and Safety </p>
<p>Monitoring Requirements: The NIH policy for data and safety
monitoring requires oversight and monitoring of all NIH-conducted or -supported
human biomedical and behavioral intervention studies (clinical trials) to
ensure the safety of participants and the validity and integrity of the data.
Further information concerning these requirements is found at
http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application
instructions (SF424 (R&R) and PHS 398). </p>
<p>Investigational New Drug or Investigational Device Exemption
Requirements: Consistent with federal regulations, clinical research projects
involving the use of investigational therapeutics, vaccines, or other medical
interventions (including licensed products and devices for a purpose other than
that for which they were licensed) in humans under a research protocol must be
performed under a Food and Drug Administration (FDA) investigational new drug
(IND) or investigational device exemption (IDE). </p>
<div class="heading4">Prior Approval of Pilot Projects</div>
<p>Awardee-selected projects that involve {clinical trials or
studies involving greater than minimal risk to human subjects} require prior
approval by NIH prior to initiation. </p>
<ul>
<li> The awardee institution will comply with the NIH <a
href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-128.html">Guidance
on Changes That Involve Human Subjects in Active Awards and That Will Require
Prior NIH Approval</a>. </li>
<li> The awardee institution will provide NIH with specific plans for
data and safety monitoring, and will notify the IRB and NIH of serious adverse
events and unanticipated problems, consistent with <a
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=21600">NIH DSMP
policies</a>. </li>
</ul>
<div class="heading3">2. Administrative and
National Policy Requirements</div>
<p>All NIH grant and cooperative agreement awards include the <a
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11120"><i>NIH
Grants Policy Statement</i></a> as part of the NoA. For these terms of award,
see the <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11157"><i>NIH
Grants Policy Statement</i> Part II: Terms and Conditions of NIH Grant Awards,
Subpart A: General</a> and <a
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11159">Part II:
Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for
Specific Types of Grants, Grantees, and Activities</a>. More information is
provided at <a
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11158">Award
Conditions and Information for NIH Grants</a>.</p>
<p>Recipients of federal financial assistance (FFA) from HHS
must administer their programs in compliance with federal civil rights laws
that prohibit discrimination on the basis of race, color, national origin,
disability, age and, in some circumstances, religion, conscience, and
sex. This includes ensuring programs are accessible to persons with
limited English proficiency. The HHS Office for Civil Rights provides guidance
on complying with civil rights laws enforced by HHS. Please see <a
href="https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html">https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html</a> and <a href="https://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html">http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html</a>.</p>
<p>HHS recognizes that research projects are often limited in
scope for many reasons that are nondiscriminatory, such as the principal
investigator&rsquo;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 FOA.</p>
<ul>
<li> Recipients of FFA must ensure that their programs are accessible
to persons with limited English proficiency. HHS provides guidance to
recipients of FFA on meeting their legal obligation to take reasonable steps to
provide meaningful access to their programs by persons with limited English
proficiency. Please 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>. For further guidance on providing
culturally and linguistically appropriate services, recipients should review
the National Standards for Culturally and Linguistically Appropriate Services
in Health and Health Care at <a
href="https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53">https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53</a>. </li>
<li> Recipients of FFA also have specific legal obligations for
serving qualified individuals with disabilities. Please 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. Please 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>;
https://www2.ed.gov/about/offices/list/ocr/docs/shguide.html; and <a
href="https://www.eeoc.gov/eeoc/publications/upload/fs-sex.pdf">https://www.eeoc.gov/eeoc/publications/upload/fs-sex.pdf</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> Recipients of FFA must also administer their programs in
compliance with applicable federal religious nondiscrimination laws and
applicable federal conscience protection and associated anti-discrimination
laws. Collectively, these laws prohibit exclusion, adverse treatment,
coercion, or other discrimination against persons or entities on the basis of
their consciences, religious beliefs, or moral convictions. Please 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>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>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 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>The following
special terms of award are in addition to, and not in lieu of, otherwise
applicable U.S. Office of Management and Budget (OMB) 2 CFR Part 200
Administrative Regulations, U.S. Department of Health and Human Services (DHHS)
grant administration regulations at 45 CFR Part 75, NIH Grants Policy Statement
(which implements the aforementioned HHS Regulations (45 CFR Part 75), and
other HHS, PHS, and NIH grant administration policies. </p>
<p>The administrative and funding instrument used for this
program will be the cooperative agreement, an "assistance" mechanism
(rather than an "acquisition" mechanism), in which substantial NIH
programmatic involvement with the awardees is anticipated during the performance
of the activities. Under the cooperative agreement, the NIH purpose is to
support and stimulate the recipients' activities by involvement in and
otherwise working jointly with the award recipients in a partnership role; it
is not to assume direction, prime responsibility, or a dominant role in the
activities. Consistent with this concept, the dominant role and prime
responsibility resides with the awardees for the project as a whole, although
specific tasks and activities may be shared among the awardees and the NIH as
defined below.</p>
<p><b>The PD(s)/PI(s) will have the primary
responsibility for:</b></p>
<ul type=disc>
<li>Planning and
conducting the activities and operations defined by the terms and
conditions of the cooperative agreement award. </li>
<li>Conducting the
scientific research in the project, reporting progress and objectives to
NIH staff, and reporting results to the scientific community.</li>
<li>Awardees will be expected to participate in
additional collaborative research activities identified post-award by the Serological
Sciences Network (SeroNet) Steering
Committee (SC).</li>
<li>Assuming
responsibility and accountability to the applicant organization officials
and to the NIH for the performance and proper conduct of the research and
administrative functions supported under this Funding Opportunity
Announcement in accordance with the terms and conditions of award, and
pertinent laws, regulations and policies.</li>
<li>Actively
participating in a cooperative, interactive, and collaborative manner with
NIH staff, FNLCR Serology Lab staff, other SeroNet investigators, Capacity
Building Centers (CBC), and the Coordinating Center at FNLCR, to maximize
impact of the SeroNet and meet Program goals and objectives. This includes
serving as a member of the SeroNet SC, as described below.</li>
<li>Maintaining the
confidentiality of the information developed or handled by the SeroNet,
including, without limitation, unpublished data, protocols, data analysis,
confidential exchanges between members of the SeroNet as well as any
confidential information received by third party collaborators. </li>
<li>To ensure compliance with NIH and
individual IC open-access expectations, each SeroNet
investigator is responsible for: </li>
</ul>
<p class=P_SingleIndentCxSpFirst> Ensuring all resulting
publications and the underlying primary data are immediately and broadly
available to the public, without embargo.</p>
<p class=P_SingleIndentCxSpMiddle> Ensuring protocols, standard
operating procedures (SOPs), and computational tools and other software are
made broadly available. </p>
<p class=P_SingleIndentCxSpMiddle> Ensuring the timely sharing of
data both within a Center and across the Network and with the broader research
community.</p>
<p class=P_SingleIndentCxSpMiddle> Ensuring the sharing of data
through the Serological Sciences Network Coordination Center and other
controlled access databases, consistent with achieving the goals of this
program.</p>
<p class=P_SingleIndentCxSpMiddle> Ensuring if a human study
(clinical trial or observational study) is planned the Data Sharing Plan should
address participants' Study Consents and include (whenever possible) the option
to use data and/or biospecimens for future research studies.</p>
<p class=P_SingleIndentCxSpMiddle> Ensuring that any industry
collaborations are governed by an appropriate </p>
<p class=P_SingleIndent>confidentiality disclosure agreement (CDA) with terms that ensure the collaboration is conducted in
accordance with the Cooperative Agreement, applicable NIH policies and
procedures and any policies and procedures developed by the SC.</p>
<p class=P_SingleIndentCxSpMiddle> Operating in
accordance with processes, goals, and policies established by the SeroNet SC.</p>
<p class=P_SingleIndentCxSpMiddle> Attending regular
Investigator meetings of the SeroNet.</p>
<p class=P_SingleIndentCxSpLast> Participating in site visits of
NIH Program staff members as requested/needed. </p>
<p><b><i>Awardees
must adhere to a Network Communication Plan:</i></b><i> </i>A consensus
Communication Plan will be drafted by the SC during the Kickoff Meeting of the
SeroNet. This plan will clearly spell out interactive requirements that all
SeroNet investigators are expected to follow, including:</p>
<p> Participating in regular conference
calls and contributing to various sub-committees and working groups;</p>
<p> Participating and presenting findings
at SeroNet investigator meetings; </p>
<p> Cooperating with the
Serological Sciences Network Coordinating Center (SSNCC) in support of
trans-Network interactions</p>
<p> Coordinating efforts with other
members of the SeroNet</p>
<ul type=disc>
<li>In addition to
standard annual Research Performance Progress Report (RPPR) submissions,
Principal Investigators may be expected to supply additional
progress-related information.</li>
</ul>
<p class=P_SingleIndent>SeroNet PD(s)/PI(s) are also expected to organize and
participate in collaborative activities and scientific or programmatic working
groups.</p>
<p><b><i>NIH staff</i></b><i> <b>will have
substantial programmatic involvement that is above and beyond the normal
stewardship role in awards, as described below:</b></i></p>
<p>A NIH Program Director acting as Program Official will
named in the Notice of Grant award and will be responsible for the normal
scientific and programmatic stewardship of the award and will be named in the
award notice. The Program Official will make final decisions for the release of
set-aside funds, based on the recommendation of the Steering Committee. </p>
<p>Additionally, designated NIH staff member(s) serving as
Project Scientist(s) will have substantial programmatic involvement that is
above and beyond the normal stewardship of an NIH Program Official.</p>
<p><b><i>NIH IC Project Scientists will be responsible for the
following activities:</i></b></p>
<p class=P_SingleIndentCxSpFirst> Assist and
coordinate interactions and collaborations among the various investigators and
any industrial partners and ensure access to other NIH relevant programs.</p>
<p class=P_SingleIndentCxSpMiddle> Serve as a resource
for the research teams in making them aware of other ongoing NIH activities
that may be relevant to the study.</p>
<p class=P_SingleIndentCxSpMiddle> Participate in site
visits, as appropriate</p>
<ul type=disc>
<li>Evaluate the
effectiveness and facilitate consortium-wide adoption of data- and
tool-sharing and interoperability practices.</li>
</ul>
<ul type=disc>
<li>Ensure that the
SeroNet data and resources are shared with the SSNCC in accordance with
applicable policies.</li>
</ul>
<ul type=disc>
<li>The NIH also
retains the option of organizing periodic external review of progress of
the work supported by the SeroNet award.</li>
<li>In addition, FNLCR
Staff managing the SSNCC will:</li>
<ul type=circle>
<li>Coordinate the
activities SeroNet-SC, as described below </li>
<li>Organize SeroNet
investigator meetings and working groups</li>
<li>Coordinate and
support sharing of samples, reagents and data across SeroNet </li>
</ul>
</ul>
<p>The NIH
reserves the right to terminate any SeroNet award in the event of (1) A
substantial shortfall in accomplishing the management goals and
responsibilities as stated in the reviewed application, (2) A failure to meet
the SeroNet policies and procedures, (3) Substantive changes in the management
of the SeroNet award that are not in keeping with the objectives of the FOA,
(4) A failure to accomplish the scientific goals.</p>
<p><b>Areas of Joint Responsibility include:</b></p>
<p>The Serological Sciences Network (SeroNet) Steering Committee (SC) (SeroNet-SC) serves as
the main governing board of the Network. All major scientific and policy
decisions will be determined by the SeroNet SC. NIH Project Scientists involved
with the management of the SeroNet will help the SC develop and draft sharing and
operating policies that are in accordance with NIH guidelines.</p>
<p>Awardees will be responsible for accepting and
implementing the goals, priorities, procedures, protocols, and policies agreed
upon by the SeroNet-SC to the extent consistent with grants regulations. This
includes compliance with program policies including, as applicable, policies on
the use of common protocols, publication of study results, collaborative
procedures, confidentiality, and sharing plans to be developed by the SC in
collaboration with NIH.</p>
<p class=Normal1><b><i>Steering Committee:</i></b> The
SeroNet Steering Committee will be composed of the following members:</p>
<p class=Normal1> One PD(s)/PI(s) from each of the SeroNet U01/U54 awards, CBCs,
FNLCR Serology Lab and FNLCR Coordinating Center</p>
<p class=Normal1>And</p>
<p class=Normal1> An NIH Project Scientist from each participating IC</p>
<p class=Normal1>Additional NIH staff may participate in
Steering Committee meetings as needed (for example to provide additional
expertise).</p>
<p class=Normal1>Additional non-voting members are
encouraged to participate on the Steering Committee in an advisory capacity.</p>
<p class=Normal1>The Chair(s) of the Steering Committee (who
cannot be NIH staff) will be selected by the Steering Committee. The Steering
Committee will meet in association with the PI meetings and via teleconferences
as needed.</p>
<p class=Normal1>The Steering Committee may establish subcommittees
or working groups for specific purposes.</p>
<p><b><i>The SeroNet SC has the following primary
responsibilities:</i></b></p>
<p>The SC will be tasked with establishing guidelines and
agreements with regard to Network-specific scientific, strategic and
administrative issues. Specific activities of the SeroNet SC will include, but
are not limited to:</p>
<ul type=disc>
<li>Establishing procedures for the solicitation,
evaluation and recommendation to awardees of collaborative/joint projects
to be pursued with support of the set-aside funds from individual U01 and
U54 awards;</li>
</ul>
<ul type=disc>
<li>Identifying
opportunities for sharing techniques, materials, information and tools
developed within each individual SeroNet Center;</li>
</ul>
<ul type=disc>
<li>Facilitating the
development and utilization of SeroNet defined data and metadata standards
and formats;</li>
</ul>
<ul type=disc>
<li>Facilitating
communication and fostering collaboration across the SeroNet;</li>
</ul>
<ul type=disc>
<li>Reviewing progress
of the SeroNet towards meeting the overall Network goals;</li>
</ul>
<ul type=disc>
<li>Developing
publication policies to facilitate collaborations and co-publications by
Network members;</li>
</ul>
<ul type=disc>
<li>Developing
implementation processes and workflows for sharing data, tools, and
resources generated by the SeroNet;</li>
</ul>
<ul type=disc>
<li>Ensuring that the
SeroNet leverages existing NIH resources and programs;</li>
</ul>
<p class=P_SingleIndentCxSpFirst> Evaluating collaborative activities
and providing feedback to the NIH Program Staff;</p>
<ul type=disc>
<li>Discussing
implementation of recommendations or suggestions from the NIH and any
external consultants and planning a timely implementation strategy.</li>
</ul>
<p><b>Dispute Resolution:</b></p>
<p>Any disagreements that may arise in scientific or
programmatic matters (within the scope of the award) between award recipients
and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel
composed of three members will be convened. It will have three members: a
designee of the Steering Committee chosen without NIH staff voting, one NIH
designee, and a third designee with expertise in the relevant area who is
chosen by the other two; in the case of individual disagreement, the first
member may be chosen by the individual awardee. This special dispute resolution
procedure does not alter the awardee's right to appeal an adverse action that
is otherwise appealable in accordance with PHS regulation 42 CFR Part 50,
Subpart D and HHS regulation 45 CFR Part 16.</p>
<div class="heading3">3. Reporting</div>
<p>When multiple years are involved, awardees will be required
to submit the <a href="//grants.nih.gov/grants/rppr/index.htm">Research Performance Progress Report
(RPPR)</a> annually and financial statements as required in the <a
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11161"><i>NIH
Grants Policy Statement</i>.</a> </p>
<p><a name=SectionVII></a>A final RPPR, invention statement, and the expenditure data portion of the
Federal Financial Report are required for closeout of an award, as described in
the <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11161"><i>NIH
Grants Policy Statement</i></a>.</p>
<p>The Federal Funding Accountability and Transparency Act of
2006 (Transparency Act), includes a requirement for awardees of Federal grants
to report information about first-tier subawards and executive compensation
under Federal assistance awards issued in FY2011 or later. All awardees 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.htm?id=11170">www.fsrs.gov</a> on all subawards over $25,000. See the <a
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11171"><i>NIH
Grants Policy Statement</i></a> for additional information on this reporting
requirement.</p>
<p>In accordance with the regulatory requirements provided at
45 CFR 75.113 and Appendix XII to 45 CFR Part 75, 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 Award
Term and Conditions for Recipient Integrity and Performance Matters.</p>
<p>Funds awarded
using appropriations provided by the <a
href="https://www.congress.gov/bill/116th-congress/house-bill/266">H.R.266</a> (PL 116-139) Paycheck Protection
Program and Health Care Enhancement Act will be issued
in unique subaccounts in the HHS Payment Management System, and will require
separate financial reporting from any other funds awarded.</p>
<div class="heading2"><a name="_Toc258873272"></a><a
name="_Section_VII._Agency"></a>Section VII. Agency Contacts</div>
<p>We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants. <br>
<br>
</p>
<div class="heading4">Application Submission Contacts</div>
<p>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>Finding Help Online: http://grants.nih.gov/support/ (preferred
method of contact)<br>
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)</p>
<p>General Grants Information
(Questions regarding application instructions, application processes, and NIH
grant resources)<br>
Email: <a href="/cdn-cgi/l/email-protection#1f586d7e716b6c567179705f71767731787069"><span class="__cf_email__" data-cfemail="460134272832350f28202906282f2e68212930">[email&#160;protected]</span></a> (preferred
method of contact)<br>
Telephone: 301-945-7573</p>
<p>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#592a2c2929362b2d193e2b38372d2a773e362f"><span class="__cf_email__" data-cfemail="03707673736c7177436471626d77702d646c75">[email&#160;protected]</span></a><br>
<br>
</p>
<div class="heading4">Scientific/Research Contact(s)</div>
<p><b>Juli Klemm, PhD<br>
</b>National Cancer Institute (NCI)<br>Telephone: 301.480.5778<br>
Email: <a href="/cdn-cgi/l/email-protection#ef84838a828285af828e8683c1818687c1888099"> <span class="__cf_email__" data-cfemail="1c7770797171765c717d757032727574327b736a">[email&#160;protected]</span></a></p>
<p><b>Samantha Finstad, PhD</b></p>
<p>National Cancer Institute (NCI)<br>
Telephone: 240.276.6460<br>
Email: <a href="/cdn-cgi/l/email-protection#6635070b0708120e0748200f081512070226080f0e48010910"> <span class="__cf_email__" data-cfemail="782b191519160c1019563e11160b0c191c38161110561f170e">[email&#160;protected]</span></a></p>
<p><b>Erik J. Stemmy, Ph.D.</b><br>
National Institute of Allergy and Infectious
Diseases (NIAID)<br>
Telephone: 240-627-3380<br>
Email: <a href="/cdn-cgi/l/email-protection#84e1f6edefaaf7f0e1e9e9fdc4eaedecaae3ebf2"><span class="__cf_email__" data-cfemail="2f4a5d4644015c5b4a4242566f41464701484059">[email&#160;protected]</span></a></p>
<div class="heading4">Peer Review Contact(s)</div>
<p>Referral Officer<br>
National Cancer Institute (NCI)<br>
Telephone: 240-276-6390<br>
Email: <a href="/cdn-cgi/l/email-protection#5f313c362d3a3930391f3b3a3e71313c367131363771383029"><span class="__cf_email__" data-cfemail="0d636e647f686b626b4d69686c23636e6423636465236a627b">[email&#160;protected]</span></a></p>
<div class="heading4">Financial/Grants Management Contact(s)</div>
<p>Crystal Wolfrey<br>
National Cancer Institute (NCI)<br>
Telephone: 240-276-6277<br>
Email: <a href="/cdn-cgi/l/email-protection#a9eadbd0daddc8c587dec6c5cfdbccd0e9c7c0c187cec6df"><span class="__cf_email__" data-cfemail="8bc8f9f2f8ffeae7a5fce4e7edf9eef2cbe5e2e3a5ece4fd">[email&#160;protected]</span></a>
</p>
<p>Ann
Devine<br>
National Institute of Allergy and Infectious Diseases (<a href="http://www.niaid.nih.gov/">NIAID</a>)<br>
Telephone: 240-669-2988<br>
Email: <a href="/cdn-cgi/l/email-protection#b3f2dddd9df7d6c5daddd6f3dddad2dad79ddddadb9dd4dcc5"><span class="__cf_email__" data-cfemail="e4a58a8acaa081928d8a81a48a8d858d80ca8a8d8cca838b92">[email&#160;protected]</span></a></p>
<div class="heading2"><a name="_Toc258873273"></a><a
name="_Section_VIII._Other"></a>Section VIII. Other
Information</div>
<p>Recently issued trans-NIH <a
href="//grants.nih.gov/grants/guide/url_redirect.htm?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.htm?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 <a
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11120">NIH Grants Policy Statement</a>.</p>
<div class="heading4">Authority and Regulations</div>
<p>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. </p>
</div>
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