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<TITLE>Expired PAR-17-190: Maximizing Investigators' Research Award for Early Stage Investigators (R35)</TITLE>
<META NAME="description" CONTENT="NIH Funding Opportunities and Notices in the NIH Guide for Grants and Contracts: Maximizing Investigators' Research Award for Early Stage Investigators (R35) PAR-17-190. NIGMS">
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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>
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<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 Institute of General Medical Sciences (<a
href="http://www.nigms.nih.gov">NIGMS</a>)</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">Maximizing Investigators' Research Award
for Early Stage Investigators (R35)</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=r35&Search.x=0&Search.y=0&sort=ac&Search_Type=Activity&text_prev=">R35</a> Outstanding Investigator Award</p></div>
</div><!--end row-->
<div class="row">
<div class="col-md-4 datalabel">Announcement Type</div>
<div class="col-md-8 datacolumn"><p>Reissue of <a
href="https://grants.nih.gov/grants/guide/rfa-files/RFA-GM-17-004.html">RFA-GM-17-004</a></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>
<strong>February 24, 2020</strong> - This PAR has been reissued as <a href="//grants.nih.gov/grants/guide/pa-files/PAR-20-117.html">PAR-20-117</a>.
</li>
<li><strong>October 7, 2019</strong> - Notice of Intent to Publish a Funding Opportunity Announcement for Maximizing Investigators' Research Award (MIRA) for Early Stage Investigators (R35 - Clinical Trial Optional). See Notice <a href="//grants.nih.gov/grants/guide/notice-files/NOT-GM-19-061.html">NOT-GM-19-061</a>.</li>
<li><b>August 23, 2019</b> -
Clarifying Competing Application Instructions and Notice of Publication of Frequently Asked Questions (FAQs) Regarding Proposed Human Fetal Tissue Research. See Notice
<a href="/grants/guide/notice-files/NOT-OD-19-137.html">NOT-OD-19-137</a>.
</li>
<li><b>July 26, 2019</b> -
Changes to NIH Requirements Regarding Proposed Human Fetal Tissue Research. See Notice <a href="/grants/guide/notice-files/NOT-OD-19-128.html">NOT-OD-19-128</a>.
</li>
<li><b>May 13, 2019</b> - NIGMS-Managed HIV/AIDS Research Portfolio Transitioning to NIAID. See Notice <a href="/grants/guide/notice-files/NOT-GM-19-039.html">NOT-GM-19-039</a>.</li>
<li><strong>December 20, 2018</strong> - Notice of Change to Requirement for Letter of Support from the Applicant Institution's Authorized Organizational Representative in PAR-17-190. See Notice <a href="//grants.nih.gov/grants/guide/notice-files/NOT-GM-19-009.html">NOT-GM-19-009</a>.</li>
<li><b>November 26, 2018</b> - NIH & AHRQ Announce Upcoming Updates to Application Instructions and Review Criteria for Research Grant Applications. See Notice <a href="/grants/guide/notice-files/NOT-OD-18-228.html">NOT-OD-18-228</a>.</li>
<li><a href="//grants.nih.gov/grants/guide/notice-files/NOT-GM-18-046.html">August 10, 2018</a> - Reminder of Required Letter of Support for PAR-17-190. See Notice <a href="//grants.nih.gov/grants/guide/notice-files/NOT-GM-18-046.html">NOT-GM-18-046</a>.</li>
<li><a href="//grants.nih.gov/grants/guide/notice-files/NOT-GM-18-013.html">December 21, 2017</a> - Notice of Correction to Eligibility Information in PAR-17-190. See Notice <a href="//grants.nih.gov/grants/guide/notice-files/NOT-GM-18-013.html">NOT-GM-18-013</a>.</li>
<li>
<a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-18-009.html">NOT-OD-18-009</a> -
Reminder: FORMS-E Grant Application Forms and Instructions Must be Used for Due Dates On or After January 25, 2018.
</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">PAR- 17-190 </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><a
href="https://grants.nih.gov/grants/guide/pa-files/PAR-17-094.html">PAR-17-094</a>, <a
href="//grants.nih.gov/grants/funding/ac_search_results.htm?text_curr=r35&Search.x=0&Search.y=0&sort=ac&Search_Type=Activity&text_prev=">R35</a> Outstanding Investigator Award</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>93.859 </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>The Maximizing Investigators' Research Award (MIRA) under
this FOA is a grant to provide support for the program of research in an <a
href="https://grants.nih.gov/policy/new_investigators/index.htm">early stage
investigator's</a> laboratory that falls within the mission of NIGMS. For the
purpose of this FOA, a program of research is the collection of projects in
the investigator's lab that are relevant to the mission of NIGMS. The goal of
MIRA is to increase the efficiency and efficacy of NIGMS funding. It is
anticipated that this mechanism will: </p>
<p class=Bullet> Increase the stability of funding for NIGMS-supported
investigators, which could enhance their ability to take on ambitious scientific
projects and approach problems more creatively. </p>
<p class=Bullet> Increase flexibility for investigators to follow important new
research directions as opportunities arise, rather than being bound to
specific aims proposed in advance of the studies. </p>
<p class=Bullet> More widely distribute funding among the nation's highly
talented and promising investigators to increase overall scientific
productivity and the chances for important breakthroughs. </p>
<p class=Bullet> Reduce the time spent by researchers writing and reviewing
grant applications, allowing them to spend more time conducting research. </p>
<p class=Bullet> Enable investigators to devote more time and energy to
mentoring trainees in a more stable research environment. </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>March 3, 2017</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>September 3, 2017 </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>October 3, 2017; October 3, 2018; October 3, 2019, 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 these dates.</p>
<p>Applicants are encouraged to apply early to allow adequate
time to make any corrections to errors found in the application during the
submission process by the due date.</p></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>February/March 2018, February/March 2019, February/March 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>May 2018, May 2019, May 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>July 1, 2018; July 1, 2019; July 1, 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>October 4, 2019 </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 Research (R) 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>
<div class="heading4"><a name="_Toc258873267"></a>Purpose</div>
<p>Supporting fundamental research by funding individual
projects has a number of consequences for the efficiency and effectiveness of
the biomedical research enterprise in the U.S. To address these issues
and increase the efficiency and efficacy of its funding mechanisms, NIGMS established
the Maximizing Investigators' Research Award (MIRA) program to award a single grant
to provide support for the program of research in an investigator's laboratory
that is related to the mission of NIGMS. For the purpose of this FOA, a
program of research is the collection of projects in an early stage Program Director/Principal
Investigator's (PD/PI's) lab that are relevant to the mission of NIGMS.
(See: <a
href="https://www.nigms.nih.gov/research/mechanisms/MIRA/pages/default.aspx">MIRA web page</a> <a
href="https://www.nigms.nih.gov/research/mechanisms/MIRA/pages/default.aspx">https://www.nigms.nih.gov/research/mechanisms/MIRA/pages/default.aspx</a>.
For research in the NIGMS mission, see: <a
href="https://www.nigms.nih.gov/about/overview/pages/default.aspx">https://www.nigms.nih.gov/about/overview/pages/default.aspx</a>.)</p>
<p>It is anticipated that this funding mechanism will achieve
the following:</p>
<ul>
<li> Increase the stability of funding for NIGMS-supported
investigators, which could enhance their ability to take on ambitious
scientific projects and approach problems more creatively;</li>
<li> Increase flexibility for investigators to follow important new
research directions as opportunities arise, rather than being bound to specific
aims proposed in advance of the studies;</li>
<li> More widely distribute funding among the nation's highly talented
and promising investigators to increase overall scientific productivity and the
chances for important breakthroughs;</li>
<li> Reduce the time spent by researchers writing and reviewing grant
applications, allowing them to spend more time conducting research; and</li>
<li> Enable PD(s)/PI(s) to devote more time and energy to mentoring
junior scientists in a more stable research environment.</li>
</ul>
<p>In developing MIRA, NIGMS is committed to maintaining
support for at least the current total number of NIGMS-funded investigators and
their associated programs of research. The Institute will also work to ensure
that it maintains a broad and diverse research portfolio in terms of scientific
areas, approaches, regional and institutional distribution, investigator career
stages, and investigator backgrounds. Such diversity will optimize returns on
the Institute's investments by maximizing the ideas explored and the chances
for important breakthroughs. </p>
<p>The NIGMS MIRA program is similar to other NIH R35 awards in
that it provides support for the research projects in a single investigator's
laboratory that are in the mission of the institute; however, MIRA differs from
the other R35 programs in that it is eventually intended to support most NIGMS
investigators. </p>
<div class="heading4">Overview of the MIRA</div>
<p>An NIGMS MIRA grant is intended to provide support for the <a
href="http://www.nigms.nih.gov/about/overview/pages/default.aspx">NIGMS-related research</a> in
an investigator's laboratory. NIGMS supports research on technology
development and computational approaches, as well as basic biomedical sciences,
translational, and clinical research, and all phases of the scientific process,
not only hypothesis testing. Within the scope of the MIRA, investigators
will have the freedom to explore new avenues of inquiry that arise during the
course of their research, as long as they remain within the mission of
NIGMS. Work involving the addition of human subjects, vertebrate animals,
stem cells, select agents, or a new foreign component would require prior
approval of NIH staff according to existing policies and procedures.
Research that involves a major change in scientific focus or that migrates away
from the mission of NIGMS and/or into an area of major interest of one of the
other NIH Institutes or Centers would warrant a discussion with NIGMS program
staff.</p>
<p>MIRA may not be the best mechanism to support all kinds of
research, even though it is within the NIGMS mission. For example,
clinical research, requiring highly detailed human subjects protocols and
milestones, may be more appropriately supported by other mechanisms. In
addition, since the flexibility of MIRA allows for work in any area of the
NIGMS mission, it may not be the best mechanism to support laboratories that
are fully committed to research on HIV/AIDS, which is supported with funds from
the Office of AIDS Research, NIH. Confer with NIGMS program staff (or the
Scientific/Research staff indicated in <a
href="#_Scientific/Research_Contact(s)">Section VII. Agency Contacts</a> of
this FOA) before applying for research in these areas.</p>
<p>Because the MIRA is to support a significant and ambitious
program of research, the investigator is required to devote at least 51% of
his/her time available for research to this award. The time available for
research should be determined in person-months and should not include time
expended toward teaching, administration, and/or clinical duties. The effort
committed by the PD/PI to the MIRA application should be over half of the time
available for research and expressed in person-months.</p>
<p>Because most institutions expect some commitment from
investigators to administrative, teaching and/or clinical duties, any salary
support for the PD/PI requested on the grant should generally be less than 51%
of the PD/PI's annual salary and should in no case be more than the actual
research effort the PD/PI will devote to the grant.</p>
<p>The goal of this announcement is to make the MIRA program
available to early stage investigators in their first independent faculty
position. For that reason, eligibility for this FOA is limited to early
stage investigators. Note that Early Stage Investigator status can be
extended beyond the normal 10-year window after completion of the terminal
research degree or medical residency for certain life or career events, as
described in <a
href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-034.html">NOT-OD-09-034</a> and on the <a
href="https://grants.nih.gov/policy/new_investigators/index.htm">NIH website</a>. Investigators
who applied in response to RFA-GM-16-003 and RFA-GM-17-004 are welcome to apply
provided they are still eligible ESIs, but the application must be written as a
New submission without reference to the previous review or an Introduction to a
Resubmission Application.</p>
<p>Investigators receiving a MIRA are required to relinquish
their other NIGMS research funding, including Mentored Career Development (K)
awards, except for award mechanisms listed below. Investigators with K
awards from another Institute/Center of the NIH may receive an NIGMS MIRA but
will be required to adjust their person-months of effort on those awards to be
less than the number of person-months committed to the MIRA.</p>
<p>Investigators who receive support from the NIGMS research
grants of other investigators serving, for example, as collaborators and subcontractors
on R01s and as project leaders on P01, P20, or P50 subprojects will no longer
be able to receive funds from those sources. NIGMS continues to encourage
collaborative and interdisciplinary research when it is appropriate, and
individual MIRA grantees are free to collaborate with one another or with other
investigators using funds from their individual grants to support their parts
of the team's research.</p>
<p>It is anticipated that the amount of a MIRA made under this
FOA will be somewhat larger than the current average NIGMS R01 award to early
stage investigators, while the project period will be similar to the current
average NIGMS R01 award to early stage investigators.</p>
<p>MIRA is expected to provide the following benefits to
investigators:</p>
<ul>
<li> More flexibility to pursue new ideas and opportunities as they
arise during the course of research because the award is not tied to specific
aims or predicated on completing specific, pre-defined projects;</li>
<li> Increased stability of funding through improved success rates and
more graduated, rather than all-or-none, funding decisions of R35 renewals;</li>
<li> A reduction in administrative burden associated with managing
multiple grants; and</li>
<li> A reduction in required application writing</li>
</ul>
<p>A researcher funded by a MIRA would not be provided any
other sources of NIGMS funding with the following exceptions:</p>
<ul>
<li> Grants supporting research resources;</li>
<li> Contracts;</li>
<li> Cooperative agreements whose FOAs specifically allow funding for
MIRA PD/PIs;</li>
<li> Grants supporting training, workforce development, or diversity
mechanisms; </li>
<li> Grants funding clinical trials; </li>
<li> INBRE (P20), COBRE (P20/P30), or IDeA-CTRs (U54); </li>
<li> SBIR/STTR grants; </li>
<li> Conference grants; </li>
<li> Grants supported through NIGMS HIV/AIDS-related FOAs.</li>
</ul>
<p>Supplements to MIRA grant awards: MIRA grants will be
eligible for Research Supplements to Promote Diversity in Health-Related
Research, and may be eligible for other types of administrative supplements,
including equipment supplements that may be offered by NIGMS through FOAs in
the NIH Guide. </p>
<p>Renewals: NIGMS plans for ESI MIRA awardees to be able
to renew their R35 through MIRA FOAs not limited to ESIs, e.g., through reissuances
of RFA-GM-17-002, which will provide mid-career and senior PD/PIs the
opportunity to apply to the MIRA mechanism. Because there will be fewer
applications as a result of the consolidation of separate research projects,
NIGMS anticipates a higher success rate than is the case for current research
project grants. NIGMS also anticipates there will be opportunities for
increases in the budget of MIRAs awarded to ESIs upon renewal. If an
application for renewal of the MIRA is unsuccessful, the grant will terminate
at the end of its approved project period. However, NIGMS will consider bridge
support for a period of time. In the final year of MIRA funding, PDs/PIs may
alternatively choose to submit a new NIGMS R01 grant application to resume
support of their laboratory through individual project funding. </p>
<p>Evaluation: NIGMS tested the MIRA concept for early stage
investigators on a small scale using RFA-GM-16-003 and RFA-GM-17-004, allowing
the number of applications and phase-in of the MIRA program to be carefully
managed and assessed. NIGMS intends to continue to evaluate the MIRA program,
monitoring both the process and the outcomes of the awards relative to the
intent of the MIRA program and the NIGMS mission. Particular attention
will be paid to maintaining and improving the diversity of the NIGMS portfolio
along all dimensions of diversity, including race/ethnicity, gender, career
stage, geography, institutional setting, and areas of scientific research. </p>
<p><a name="_Section_II._Award_1"></a>See <a
href="#_Section_VIII._Other">Section
VIII. Other Information</a> for award authorities and regulations.</p>
<div class="heading2">Section II. Award
Information</div>
<div class="row">
<div class="col-md-4 datalabel">Funding Instrument</div>
<div class="col-md-8 datacolumn"><p>Grant: A support mechanism providing money, property, or
both to an eligible entity to carry out an approved project or activity. </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.</p></div>
</div><!--end row-->
<div class="row">
<div class="col-md-4 datalabel">Clinical Trial?</div>
<div class="col-md-8 datacolumn">
<p>Clinical Trials Not Allowed for due dates on or after January 25, 2018: Only accepting applications that do not propose independent clinical trials</p>
</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></div>
</div><!--end row-->
<div class="row">
<div class="col-md-4 datalabel">Award Budget</div>
<div class="col-md-8 datacolumn"><p>Applications may request up to $250,000 direct costs per
year. Investigators are encouraged to request what is
actually well justified for their research program. Budget categories should
not include inflationary escalation for recurring costs in out-years. Cost
efficiency is one of the goals of the principles of NIGMS stewardship of
public funds and will be one of the considerations in funding decisions.</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>Applications may request a maximum project period of five
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 in response to 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=ColorfulList-Accent11>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.<br>
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>
<p>NIGMS will accept MIRA applications with foreign
collaborations, but will only provide funding for a foreign consortium
arrangement when the collaboration is essential to the PD/PI's research
program, represents a unique scientific opportunity, and cannot be supported by
the collaborator.</p>
<div class="heading4"><a name="_Required_Registrations"></a>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> (formerly CCR) Applicants must complete and maintain an active registration, <strong>which requires renewal at least
annually</strong>. The renewal process may require as much time as the
initial registration. SAM registration includes the assignment of a Commercial
and Government Entity (CAGE) Code for domestic organizations which have not
already been assigned a CAGE Code. </li>
<li class="BulletDoubleIndent"> <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 and SAM registration in order to complete the
eRA Commons registration. Organizations can register with the eRA Commons as
they are working through their SAM or Grants.gov registration. 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>PD/PIs are required to devote at least 51% of their time
available for research to this award. The time available for research should be
expressed in person-months and should not include effort expended toward
teaching, administration and/or clinical duties.</p>
<p>Only single PD/PI applications are allowed. Applications
with multiple PD(s)/PI(s) will not be accepted. </p>
<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><a name="_Toc258873269"></a><a
name="_Section_IV._Application"></a>It is anticipated that the MIRA review will
be highly competitive; therefore a PD/PI may submit an R01 application and a
MIRA application in parallel. Should both applications be selected for
funding, the PD/PI will be required to relinquish one of the awards.</p>
<p>PD/PIs who submitted a MIRA application in previous years
and are still eligible for this FOA (i.e., retain their ESI status) are welcome
to apply, but must submit a new application, rather than a resubmission.</p>
<div class="heading2"><a name="_Section_IV._Application_1"></a>Section IV. Application and Submission Information</div>
<div class="heading3">1. Requesting an
Application Package</div>
<p>Buttons to access the online ASSIST system or to download
application forms are 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 Research (R) Instructions
in the <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=12000">SF424
(R&R) Application Guide</a>, including <a
href="https://grants.nih.gov/grants/funding/424/SupplementalInstructions.pdf">Supplemental
Grant Application Instructions</a> except where instructed in this funding
opportunity announcement to do otherwise. 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>
<p>For information on Application Submission and Receipt, visit <a href="//grants.nih.gov/grants/guide/url_redirect.htm?id=41137">Frequently
Asked Questions Application Guide, Electronic Submission of Grant Applications</a>.</p>
<div class="heading4">Page Limitations</div>
<p>All page limitations 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 Application Submission</div>
<p>The following section supplements the instructions found in
the SF424 (R&R) Application Guide and should be used for preparing an
application to this FOA.</p>
<div class="heading4">SF424(R&R) Cover</div>
<p>All instructions in the SF424 (R&R) Application Guide
must be followed. </p>
<div class="heading4">SF424(R&R) Project/Performance Site Locations</div>
<p>All instructions in the SF424 (R&R) Application Guide
must be followed. </p>
<div class="heading4">SF424(R&R) Other Project Information</div>
<p>All instructions in the SF424 (R&R) Application Guide
must be followed. </p>
<p><strong>Project
Summary/Abstract:</strong> Use the abstract to provide an overview of
research in the laboratory, the goals for the next five years, and an overall
vision of the research program. This document should serve both the needs of
the public and the needs of the reviewers for an introduction to the research
plan </p>
<div class="heading4">SF424(R&R) Senior/Key Person Profile </div>
<p>All instructions in the SF424 (R&R) Application Guide
must be followed. </p>
<p><strong>Biographical
Sketch</strong>: Use the Personal Statement to address MIRA specific
elements of the Investigator Review Criterion. Include descriptions of
significant service and contributions to the research community. Under the
section on Research Contributions, emphasize especially contributions over the
past five years. Include a link to your My Bibliography complete list of publications
and be sure the data are complete and up to date.</p>
<p>Do not use the Biosketch to circumvent page limits of the Research
Strategy by including figures or preliminary data.</p>
<p>Include Biosketches for any subcontracted independent
investigators and include the same information that is requested for the
PD/PI. </p>
<p><strong>Current
& Pending Support</strong>: Use the SF424 R&R Current and
Pending Support instructions as modified here and attach this information to
the Senior/Key Personnel Form. For this application, list Annual Direct Costs
allocated to the MIRA PD/PI's laboratory, only.</p>
<p>List NIGMS grants first, followed by other NIH grants, followed
by other sources of support.</p>
<div class="heading4">R&R Budget</div>
<p>All instructions in the SF424 (R&R) Application Guide
must be followed. Note especially that the time available for research should
be expressed in person-months and should be over half (at least 51%) of the total
time available for research. In the budget justification, in addition to
stating the PD/PI's commitment of effort to MIRA, the PD/PI must also state
their total research time in person-months. Research time does not include time
expended toward teaching, administration and/or clinical duties. </p>
<p>While a 10-year R&R Detailed Budget form is provided in
the application package, applicants may not request more than 5 years of
support. Budget categories should not include inflationary (cost-of-living)
escalation for recurring costs in out years regardless of whether or not the
annual total direct costs remain constant.</p>
<div class="heading4">R&R Subaward Budget</div>
<p>All instructions in the SF424 (R&R) Application Guide
must be followed. </p>
<p>Consortium/Contractual Arrangements are not anticipated in
most cases and must be extremely well justified.</p>
<div class="heading4">PHS 398 Cover Page Supplement</div>
<p>All instructions in the SF424 (R&R) Application Guide
must be followed. </p>
<div class="heading4">PHS 398 Research Plan</div>
<p>All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions: </p>
<p><strong>Specific
Aims</strong>: Do not submit Specific Aims.</p>
<p><strong>Research
Strategy</strong>: MIRA applications should not use the typical R01
application headings of Significance, Innovation, and Approach. This section
should contain the following information: 1) Background on the area(s) of
research and key gaps in our understanding or important challenges to be
addressed; 2) Recent Progress by the PD/PI, focusing on the past five years, to
give context for the overview of future research. Do not repeat material
adequately covered in the Biosketch. Do NOT include a Publication List.
Instead, include references as necessary in the Bibliography & References
Cited section in the Other Project Information Form. 3) Overview of Future
Research. This should be a description of the key questions or challenges the
PD/PI plans to address and the general strategies that might be used to
approach them. The focus should be on the importance of the questions or
challenges. A detailed experimental plan is not expected. Although the proposed
direction of the PD/PI's scientific program will be considered in review, if
new opportunities or directions arise during the course of the research, the
PD/PI will have the flexibility to change course and pursue them. Note that cost
efficiency is both one of the goals of the MIRA program and a central principle
of NIGMS stewardship of public funds; the proposed approaches should therefore
reflect sensitivity to the issue of cost-efficiency.</p>
<p>Given that the MIRA is intended to enable consolidation of
NIGMS support for multiple projects that may be disparate, there is no obligation
to develop a single unifying theme. Applicants should directly address the
rationale underlying the balance of effort and the resources dedicated to each
activity, and how the activities are distinct or complementary. </p>
<p><strong>Letters
of Support</strong>: The application must include a letter from the
institution's Authorized Organizational Official (AOR) indicating that they are
aware of and accept the condition that other NIGMS research awards must be
relinquished and pending NIGMS research applications, except as allowed in <a
href="#_Section_I._Funding">Section I</a>, withdrawn as a condition of
receiving a MIRA, and providing a statement that if chosen to receive an award,
the PD/PI will devote at least 51% of their time available for research to this
award. The time available for research should be determined in person-months
and should not include time expended towards teaching, administration, and/or
clinical duties. In addition, a letter of support should be included from the
department chair, dean, or other academic unit leader testifying to the
institutional commitment to development of the investigator and any other
pertinent information. This information could include start-up packages and
other institutional research support, space available to the PD/PI, salary
support commitment for the PD/PI, skills and career development opportunities
for the PD/PI, mentoring during the promotion and tenure process, and career
advancement prospects for non-tenure track applicants. Letters from
former mentors are not required, nor encouraged, except in the case of
continuing collaborations.</p>
<p>Letters of support from collaborators must be limited to 1
to 2 pages, must not include attached Biographical Sketches, and should not circumvent
page limitations by including figures and data.</p>
<p>Applications involving a consortium/contractual arrangement are
expected to be rare. If a consortium/contractual arrangement must be included,
the application must also include a letter from the subcontract PD/PI indicating
why they cannot participate in collaborative research with the PD/PI without
support from the MIRA. </p>
<p><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 include a Data Sharing Plan.</li>
</ul>
<p><strong>Appendix: </strong></p>
<p> Do
not use the Appendix to circumvent page limits. Follow all instructions for the
Appendix as described in the SF424 (R&R) Application Guide. </p>
<div class="heading4">PHS Inclusion Enrollment Report</div>
<p>Form only available in FORMS-D application packages for use with due dates on or before January 24, 2018.</p>
<p>When conducting clinical research, follow all instructions
for completing PHS Inclusion Enrollment Report as described in the SF424
(R&R) Application Guide. </p>
<!--CT MARKER-->
<!--RESEARCH PHS HS CT TEXT START-->
<div class="heading4">PHS Human Subjects and Clinical Trials Information</div>
<p>Form only available in FORMS-E application packages for use with due dates on or after January 25, 2018.</p>
<p>When involving NIH-defined human subjects research, clinical research, and/or 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>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><strong>Study Record: PHS Human Subjects and Clinical Trials Information</strong><BR>
All instructions in the SF424 (R&R) Application Guide must be followed.</p>
<p><strong>Delayed Onset Study:</strong> All instructions in the SF424 (R&R) Application Guide must be followed.</p>
<div class="heading4">PHS Assignment Request Form</div>
<p>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://www.opm.gov/Operating_Status_Schedules/fedhol/2010.asp">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). 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'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>For this FOA:</p>
<ul>
<li> A permanent change of PD/PI will not be allowed under the MIRA.
A temporary change may be allowed with prior approval under circumstances such
as sabbatical leave, medical conditions, disability, or personal or family
situations such as child or eldercare.</li>
<li> Transfer of a MIRA to a foreign institution will not be allowed.
Addition of a foreign component, including a significant new foreign
collaboration, requires prior approval; however, MIRA funds may be used to
support a subcontract at a foreign institution only if the collaboration is
essential to the PD/PI's research program, represents a unique scientific
opportunity and cannot be supported by the collaborator. </li>
<li> It is expected that the MIRA will replace all current NIGMS
funding of the laboratory. Institutions will be required to relinquish their
interests in current NIGMS-funded research grants and withdraw pending
applications where the applicant investigator is listed as the PD/PI or
multi-PD/PI. The initial budget period of the MIRA and timing of the award
will be negotiated so that a smooth transition of support takes place.</li>
<li> The PD/PI of a MIRA cannot receive funds from other NIGMS grants
(e.g. as a sub-project leader or as the recipient of a sub-contract), excepting
those listed in <span class=P_SingleIndent><a href="#_Section_I._Funding">Section I</a></span>. </li>
<li> NIGMS will not consider funding future individual PD/PI or
multiple PD/PI research grants from a MIRA investigator during the MIRA funded
project period, except for applications included under the list of exempted
awards in <span class=P_SingleIndent><a href="#_Section_I._Funding">Section I</a></span>. </li>
<li> Budget categories should not include inflationary
(cost-of-living) escalation for recurring costs in out-years, regardless of
whether or not the annual total direct costs remain constant. </li>
</ul>
<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><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="//grants.nih.gov/grants/guide/url_redirect.htm?id=11144">Applying
Electronically</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="//grants.nih.gov/grants/ElectronicReceipt/support.htm#guidelines">Guidelines
for Applicants Experiencing System Issues</a>. For assistance with application
submission, contact the Application Submission Contacts in <a
href="#_Section_VII._Agency">Section VII</a>.</p>
<p class=ColorfulList-Accent11><strong>Important
reminders:</strong></p>
<p class=ColorfulList-Accent11>All PD(s)/PI(s) 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. See <a
href="#_Required_Registrations">Section III</a> of this FOA for information on
registration requirements.</p>
<p class=ColorfulList-Accent11>The applicant organization must ensure that the
DUNS number it provides on the application is the same number used in the
organization's profile in the eRA Commons and for the System for Award Management.
Additional information may be found in the SF424 (R&R) Application Guide.</p>
<p class=ColorfulList-Accent11>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 the National Institute of General Medical Sciences, NIH.
Applications that are incomplete or non-compliant, or that do not fall within
the NIGMS mission, will not be reviewed.<a name="_Toc258873270"></a></p>
<div class="heading4"> </div>
<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>. </p>
<div class="heading2"><a name="_Section_V._Application"></a>
Section V. Application Review Information</div>
<p>
<img src="/common14/images/new.gif"> <b>Important Update:</b> See <a href="/grants/guide/notice-files/NOT-OD-18-228.html">NOT-OD-18-228</a> for updated review language
for due dates on or after January 25, 2019.
</p>
<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. As part of the <a
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11149">NIH mission</a>,
all applications submitted to the NIH in support of biomedical and behavioral
research are evaluated for scientific and technical merit through the NIH peer
review system.</p>
<p>For this particular announcement, note the following: </p>
<p>The goal of the MIRA program is to provide support for a
laboratory's research program that is within the NIGMS mission and to give
investigators relative freedom in pursuing their research goals. For this FOA,
applicants are expected to provide an overview of the research
program/scientific questions they currently plan to address and a general
description of possible strategies. Experimental details are not expected.
Given that a MIRA is intended to administratively consolidate projects that may
be scientifically disparate, there is no obligation for the PD/PI to present a
single unifying theme.</p>
<div class="heading4"> </div>
<div class="heading4">Overall Impact </div>
<p>Reviewers will provide an overall impact score to reflect
their assessment of the likelihood for the program 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
program proposed).</p>
<div class="heading4">Review Criteria</div>
<p>Reviewers will consider each of the review criteria below in
the determination of scientific merit. An application does not need to be
strong in all categories to be judged likely to have major scientific impact. For
example, a program that by its nature is not innovative may be essential to
advance a field.</p>
<h4 class="heading4Indent">Significance</h4>
<p class="P_SingleIndent">Does the program address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the program? If the overall goals of the program are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the research change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? </p>
<p class="P_SingleIndent"><strong>For this FOA: </strong>Are the theme and/or topics of the research program substantive and appropriate for long-term pursuit? Is the proposed research program appropriate in scope and ambition to address the scientific questions posed? Will the proposed research program permit the investigator to establish a uniquely independent place in the field of research? </p>
<div class="P_SingleIndent"></div>
<div class="heading4Indent">Investigator(s)</div>
<p class="P_SingleIndent">Are the PD(s)/PI(s), collaborators,
and other researchers well suited to the program? Do they have appropriate
experience and training?</p>
<p class="P_SingleIndent"><strong>For this FOA:</strong> Does the PD/PI have a
consistent record of productivity and scientific impact commensurate with the
applicant's current career stage? Is s/he clearly the intellectual driver of
the proposed research program? Has the PD/PI shown evidence of being creative
and adaptable, able to recognize new opportunities and to explore new areas of
scientific inquiry, and openness to the use of new systems and strategies, as
appropriate for the proposed research program? Does the PD/PI have strong
potential to establish a successful independent program of research in his/her
own laboratory? Does the PD/PI show promise as a mentor of undergraduate and
graduate students, and postdoctoral associates, and the potential to establish
a record of professional service? </p>
<div class="heading4Indent">Innovation</div>
<p class="P_SingleIndent">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_SingleIndent"><strong>For this FOA:</strong> Will creative strategies be
employed as needed and appropriate to address the research questions posed? </p>
<div class="heading4Indent">Approach</div>
<p class="P_SingleIndent">Is the overall strategy
well-reasoned and appropriate to accomplish the overall goals of the research program?
Has the PD/PI 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 program is in the
early stages of development, will the strategy establish feasibility and will
particularly risky aspects be managed? Has the PD/PI 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 program involves human
subjects and/or NIH-defined clinical research, are the plans to address 1) the
protection of human subjects from research risks, and 2) inclusion (or
exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as
well as the inclusion or exclusion of children, justified in terms of the
scientific goals and research strategy proposed? </p>
<p class="P_SingleIndent"><strong>For this FOA: </strong> Is there a logical plan
for sustained progress across a research program for the five-year award
period? Is there evidence that the research program will evolve appropriately
as the work is performed? Do the plans reflect sensitivity to the need for cost
effectiveness in research? </p>
<div class="heading4Indent">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
features of the scientific environment, subject populations, or collaborative
arrangements? </p>
<p class="P_SingleIndent"><strong>For this FOA: </strong>Is the environment
conducive for the PD/PI to develop as an independent researcher? Are there
appropriate facilities and institutional support to facilitate the advancement
of the PD/PI as an established investigator whose laboratory will have a
sustained impact on biomedical science? </p>
<div class="heading4">Additional Review Criteria</div>
<p>As applicable for the program 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">Protections for Human Subjects</div>
<p class="P_SingleIndent">For research that involves human subjects but does not involve one of the six 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 six 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">Inclusion of Women, Minorities,
and Children </div>
<p class="P_SingleIndent">When the proposed program of
research 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 children 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">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">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">Resubmissions</div>
<p class="P_SingleIndent">Not Applicable</p>
<div class="heading4Indent">Renewals</div>
<p class="P_SingleIndent">Not Applicable</p>
<div class="heading4Indent">Revisions</div>
<p class="P_SingleIndent">Not Applicable</p>
<div class="heading4">Additional Review Considerations</div>
<p>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">Applications from Foreign
Organizations</div>
<p class="P_SingleIndent">Not Applicable</p>
<div class="heading4Indent">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">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/url_redirect.htm?id=11153"> Genomic Data Sharing Plan (GDS)</a>.</p>
<div class="heading4Indent">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">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 NIGMS, 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>Applications will be assigned 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 National Advisory General Medical Sciences Council. The following
will be considered in making funding decisions: </p>
<ul>
<li> Scientific and technical merit of the proposed research program
as determined by scientific peer review. </li>
<li> Availability of funds. </li>
<li> Relevance of the proposed research program to program priorities. </li>
<li> Contributions to portfolio breadth and diversity as outlined in
the NIGMS Strategic Plan.</li>
</ul>
<div class="heading3"><a name="_3._Anticipated_Announcement"></a>3. Anticipated Announcement and Award Dates</div>
<p>After the peer review of the application is completed, the PD/PI
will be able to access his or her Summary Statement (written critique) via the <a
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11123">eRA Commons</a>. Refer
to Part 1 for dates for peer review, advisory council review, and earliest start
date.</p>
<p>Information regarding the disposition of applications is
available in the <a
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=11156"><i>NIH
Grants Policy Statement</i></a>. </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'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>
<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 law. This means that recipients of HHS funds must ensure
equal access to their programs without regard to a person's race, color,
national origin, disability, age and, in some circumstances, sex and religion.
This includes ensuring your programs are accessible to persons with limited
English proficiency. HHS recognizes that research projects are often limited
in scope for many reasons that are nondiscriminatory, such as the principal
investigator's scientific interest, funding limitations, recruitment
requirements, and other considerations. Thus, criteria in research protocols
that target or exclude certain populations are warranted where
nondiscriminatory justifications establish that such criteria are appropriate
with respect to the health or safety of the subjects, the scientific study
design, or the purpose of the research.</p>
<p>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. HHS provides
general 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 https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html.
The HHS Office for Civil Rights also provides guidance on complying with civil
rights laws enforced by HHS. Please see <a href="https://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html">http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html</a>;
and <a href="https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html">https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html</a>.
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>.
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. Also note it is an HHS
Departmental goal to ensure access to quality, culturally competent care,
including long-term services and supports, for vulnerable populations. 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">http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53</a>. </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'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>Not Applicable</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">NIH Grants
Policy Statement.</a> </p>
<p>For this FOA, the instructions are hereby modified as
follows:</p>
<p>a) Under Section B.1 What are the major goals of the
research? Note that the goals of the program of research supported by the MIRA
are broader than the specific aims of a single project and should be
appropriately described. If the goals of the MIRA have changed, complete
section B.1.a. Provide a rationale for the changes in the context of the
originally proposed research program and explain how the research continues to
fit within NIGMS mission interests.</p>
<p>b) Under section D.2.c. additional information, indicate if
there have been changes in Other Support. In addition to the revised Other
Support page, if there have been changes to your other support, discuss how
they affect the activities supported by the MIRA.</p>
<p><a name=SectionVII></a>A final progress report, 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>
<div class="heading4">4. Evaluation</div>
<p>In carrying out its stewardship NIGMS will evaluate the MIRA
programs, employing the measures identified below. In assessing the
effectiveness of its research investments, NIH may request information from
databases, PD/PIs, and from participants themselves. NIGMS will assess the
program's overall outcomes and gauge its effectiveness in increasing the
efficiency and efficacy of NIGMS funding. Upon the completion of a program
evaluation, NIGMS will determine whether to (a) continue the program as
currently configured, (b) continue the program with modifications, or (c)
discontinue the program.</p>
<p>Evaluation Measures: The overall evaluation of the program
will be based on metrics that will include, but are not limited to, the
following:</p>
<ul>
<li> Number of ESI PD/PIs who apply for MIRA instead of R01s</li>
<li> Publication rate of NIGMS MIRA grantees vs. traditional NIGMS
grantees.</li>
<li> Citation rate of NIGMS MIRA grantees vs. traditional NIGMS
grantees.</li>
<li> Level of interest of other NIGMS grantees and applicants in
obtaining NIGMS MIRAs.</li>
<li> Changes in NIGMS funding distribution and number of investigators
supported by the Institute. </li>
<li> Changes in the distribution over time of research topics studied
by NIGMS MIRA vs. traditional grantees.</li>
<li> Rate at which NIGMS MIRA grantees elect to apply to renew their
awards vs. re-enter the traditional system.</li>
</ul>
<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
registration, submitting and tracking an application, documenting system
problems that threaten submission by the due date, post submission issues)<br>
Finding Help Online: <a href="//grants.nih.gov/support/">http://grants.nih.gov/support/</a> (preferred method of contact)<br>
Telephone: 301-402-7469 or 866-504-9552 (Toll Free) </p>
<p><a
href="//grants.nih.gov/grants/guide/url_redirect.htm?id=82301">Grants.gov
Customer Support</a><strong> </strong>(Questions
regarding Grants.gov registration and submission, downloading forms and
application packages)<br>
Contact Center Telephone: 800-518-4726 <br>
Email: <a href="/cdn-cgi/l/email-protection#c1b2b4b1b1aeb3b581a6b3a0afb5b2efa6aeb7"><span class="__cf_email__" data-cfemail="54272124243b2620143326353a20277a333b22">[email&#160;protected]</span></a> </p>
<p class=MsoCommentText>GrantsInfo
(Questions regarding application instructions and process, finding NIH grant
resources)<br>
Email: <a href="/cdn-cgi/l/email-protection#87c0f5e6e9f3f4cee9e1e8c7e9eeefa9e0e8f1"><span class="__cf_email__" data-cfemail="8ccbfeede2f8ffc5e2eae3cce2e5e4a2ebe3fa">[email&#160;protected]</span></a> (preferred method of contact)<br>
Telephone: 301-710-0267<br><br>
</p>
<div class="heading4"><a name="_Scientific/Research_Contact(s)"></a>Scientific/Research
Contact(s)</div>
<p>Sailaja Koduri, Ph.D.<br>
National Institute of General Medical Sciences (NIGMS)<br>
Email: <a href="/cdn-cgi/l/email-protection#f380929a9f929992dd989c9786819ab39d9a9bdd949c85"><span class="__cf_email__" data-cfemail="87f4e6eeebe6ede6a9ece8e3f2f5eec7e9eeefa9e0e8f1">[email&#160;protected]</span></a></p>
<p>Michele McGuirl, Ph.D.<br>
National Institute of General Medical Sciences (NIGMS)<br>
Email: <a href="/cdn-cgi/l/email-protection#99f4fafeecf0ebf5f4f8d9f7f0fef4eab7f7f0f1b7fef6ef"><span class="__cf_email__" data-cfemail="d6bbb5b1a3bfa4babbb796b8bfb1bba5f8b8bfbef8b1b9a0">[email&#160;protected]</span></a></p>
<div class="heading4">Peer Review Contact(s)</div>
<p>Brian Pike, Ph.D.<br>
National Institute of General Medical Sciences (NIGMS)<br>
Telephone: 301-594-3907<br>
Email: <a href="/cdn-cgi/l/email-protection#57273e3c352517393e303a2479393e3f79303821"><span class="__cf_email__" data-cfemail="087861636a7a4866616f657b26666160266f677e">[email&#160;protected]</span></a></p>
<div class="heading4">Financial/Grants Management Contact(s)</div>
<p>Lisa Moeller <br>
National Institute of General Medical Sciences (NIGMS)<br>
Telephone: 301-594-3914 <br>
Email: <a href="/cdn-cgi/l/email-protection#e28f8d878e8e87908ea28f838b8ecc8c8b8acc858d94"><span class="__cf_email__" data-cfemail="c0adafa5acaca5b2ac80ada1a9aceeaea9a8eea7afb6">[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>
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<A HREF="/grants/guide/WeeklyIndex.cfm?03-03-17">Weekly TOC for this Announcement</A><br>
<A HREF="/grants/guide/index.html">NIH Funding Opportunities and Notices</A>
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