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<TITLE>Expired RFA-RM-07-009: 2007 NIH Director's New Innovator Award Program (DP2) </TITLE>
<META NAME="description" CONTENT="NIH Funding Opportunities and Notices in the NIH Guide for Grants and Contracts: 2007 NIH Director's New Innovator Award Program (DP2) RFA-RM-07-009. Roadmap">
<META NAME="Keywords" CONTENT="RFA-RM-07-009: 2007 NIH Director's New Innovator Award Program (DP2) ">
</HEAD>
<BODY BGCOLOR="#FFFFFF" TEXT="#000000">
<LINK href="nih_guide_style.css" rel="stylesheet">
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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=Section1>
<p><span class=heading1><a name="PartI"></a>Part I Overview Information</span></p>
<hr size=2 width="100%" noshade color="#999999" align=center><p class=regulartext><span class=heading3>Department of Health and Human Services</span> </p>
<p class=regulartext><span class=heading3>Participating Organizations</span><br>
National
Institutes of Health (NIH) ( <a href="http://www.nih.gov/">http://www.nih.gov</a>)</p>
<p><span class=heading3>Components of Participating
Organizations</span><br>
This FOA is developed as an NIH Roadmap initiative (<A href="//grants.nih.gov/grants/new_investigators/innovator_award/">http://grants.nih.gov/grants/new_investigators/innovator_award/</A>); all NIH Institutes and Centers are participating. This FOA is being administered by the <a href="http://www.nigms.nih.gov/">National Institute of General Medical Sciences (NIGMS)</A> on behalf of the NIH.<br>
<br>
<span class=heading3>Title:</span> <span
class=addtitle1>2007 NIH
Director's New Innovator Award Program (DP2) </span><br>
<br>
<span class=heading3>Announcement Type</span></p>
<p>New </p>
<p class=regulartext><b>Update:</b> The following update relating to this announcement has been issued: </p>
<ul>
<li><a href="//grants.nih.gov/grants/guide/rfa-files/RFA-RM-08-014.html">November 9, 2007</a> - This RFA has been reissued as (RFA-RM-08-014).</li>
<li><a href="//grants.nih.gov/grants/guide/notice-files/NOT-RM-07-007.html">March 30, 2007</a> - See Notice (NOT-RM-07-007) the purpose of this notice is to clarify the application instructions.</li>
</ul>
<p><b>NOTICE:</b> Applications
submitted in response to this Funding Opportunity Announcement (FOA) for
Federal assistance must be submitted electronically through Grants.gov (<a
href="http://www.grants.gov">http://www.grants.gov</a>) using the SF424
Research and Related (R&R) forms and the SF424 (R&R) Application Guide. </p>
<p class=regulartext><b>APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT. </b></p>
<p class=regulartext>This FOA must be read in conjunction with the application guidelines
included with this announcement in <a href="http://www.grants.gov/Apply">Grants.gov/Apply
for Grants</a> (hereafter called Grants.gov/Apply).</p>
<p class=regulartext>A registration process is necessary before submission, and applicants
are highly encouraged to start the process at least four weeks prior to the
grant submission date. See <a
href="#SectionIV">Section IV</a>.</p>
<p><span class=heading3>Request For Applications (RFA)
Number:</span> <span class="addtitle1">RFA-RM-07-009</span></p>
<p><span class=heading3>Catalog of Federal Domestic
Assistance Number(s)</span> <br>
93.310 </p>
<p><span class=heading3><a name="KeyDates"></a>Key Dates</span> <br>
Release/Posted Date: March 9, 2007<br>
Opening Date: April 25<span class=regulartext>, 2007</span> (Earliest date an
application may be submitted to Grants.gov) <br>
<span class=regulartext>Letters of Intent Receipt Date(s):</span> <span
class=regulartext>Not applicable.</span><br>
<b>NOTE: On time submission requires that applications be successfully
submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant
institution/organization).</b><br>
<span class=regulartext>Application Receipt Date(s): May 22, 2007 </span><br>
<span class=regulartext>Peer Review Date(s): July 2007</span><br>
<span class=regulartext>Advisory Council to the Director Date(s): August 2007</span><br>
<span class=regulartext>Earliest Anticipated Start Date(s): September 28,
2007</span><br>
<span class=regulartext>Additional Information to be Available: March 9,
2007 Frequently Asked Questions (FAQs) are available at </span><a
href="//grants.nih.gov/grants/new_investigators/innovator_award/faq.htm">http://grants.nih.gov/grants/new_investigators/innovator_award/faq.htm</a> <br>
<span class=regulartext>Expiration
Date: May 23, 2007</span> </p>
<p class=regulartext><span
class=heading3>Due Dates for E.O.
12372 </span></p>
<p class=regulartext><span
class=regulartext>Not Applicable </span></p>
<p class=regulartext><span
class=heading2>Additional Overview Content</span><br>
<br>
<span
class=heading3>Executive Summary </span></p>
<ul>
<li><span class=regulartext><b>Purpose</b>.<b> </b>The NIH
Director&rsquo;s New Innovator Award (</span><a href="//grants.nih.gov/grants/new_investigators/innovator_award/">http://grants.nih.gov/grants/new_investigators/innovator_award/</a></span><span
class=regulartext>), created this year, addresses two important goals:
stimulating highly innovative research and supporting promising new
investigators. New investigators may have exceptionally innovative
research ideas, but not the required preliminary data to fare well in the
traditional peer review system. As part of its commitment to increasing
the success of new investigators, NIH has created the NIH Director&rsquo;s New
Innovator Award to support exceptionally creative new investigators who propose
highly innovative approaches that have the potential to produce an unusually
high impact. The New Innovator Award program complements the more traditional
R01 mechanism, which continues to be the primary source of funding for new
investigators.</span></li>
<li><span class=regulartext><b>Mechanism of Support. </b>This
Funding Opportunity Announcement (FOA) will utilize the DP2 grant mechanism.</span>
Applications proposing multiple PIs are not allowed.</li>
<li><span class=regulartext><b>Funds Available and Anticipated
Number of Awards. </b>Total funding available for this five-year program is at
least $40 million for the five-year period. It is anticipated that at least 14
awards will be made.</span></li>
<li><span class=regulartext><b>Budget and Project Period.</b></span><b> </b><span class=regulartext>Awards will be for up to a total of $1.5
million in direct costs (average of $300,000 per year) for a five-year
budget/project period, plus applicable Facilities and Administrative costs to
be determined at the time of award.</span> <span class=regulartext><b>Renewal.</b> Competing renewal applications for a New Innovator Award will not be allowed.</span> However, at the end of the five-year project period, investigators may submit
R01applications through the standard peer review process to continue the research
conducted under the New Innovator Award.</li>
<li><b>Eligible Institutions/Organizations.</b> The following
domestic (U.S.) institutions are eligible to apply: <span class=regulartext>Public/State
Controlled Institutions of Higher Education; Private Institutions of Higher
Education; Nonprofits with 501(c)(3) IRS Status (Other than Institution of
Higher Education); Nonprofits without 501(c)(3) IRS Status (Other than
Institution of Higher Education); Small Businesses; For-Profit Organizations
(Other than Small Business); State Governments; Institutions in U.S.
Territories or Possessions; Indian/Native American Tribal Governments (Federally
Recognized); Indian/Native American Tribal Governments (Other than Federally
Recognized); Indian/Native American Tribally Designated Organizations;
Hispanic-serving Institutions; Historically Black Colleges and Universities
(HBCUs); Tribally Controlled Colleges and Universities (TCCUs); Alaska Native-
and Native Hawaiian-serving Institutions; Regional Organizations; Other(s): Eligible
agencies of the Federal Government; Faith-based or community-based
organizations.</span> Non-domestic
(non-U.S.) entities (Foreign Organizations) are not
eligible to apply.</li>
<li><b>Eligible Project Directors/Principal Investigators (PDs/PIs):
</b><span class=regulartext>Applicant PD/PI&rsquo;s must hold an independent
research position at a domestic (U.S.) institution as of September 20, 2007 and
must have received their most recent doctoral degree (e.g., Ph.D., M.D., D.D.S., D.V.M., or equivalent) or completed their medical
internship and residency in 1997 or later. For the purpose of this FOA,
independent research position means a position that is held by an investigator
who is permitted by his/her institutional policy to apply for R01 grants, with
an appropriate commitment of facilities to be used for the conduct of the
proposed research. Applicants must meet the definition of new investigator.
For the purpose of this RFA, new investigators are defined as those
applicants who have never been PI on an R01 or equivalent grant (e.g., R23,
R29, R37, or U01) or leader of a P01 or center grant
peer-reviewed project. Applicants may
submit or have an R01 grant application pending concurrently with their New
Innovator Award application. The research proposed need not be in a
conventional biomedical or behavioral discipline, but must be relevant to the
mission of NIH. Awardees are required to commit at least 30% of their research
effort to activities supported by the New Innovator Award. Women and members of
groups underrepresented in biomedical or behavioral research are especially
encouraged to apply. There are no citizenship or residency requirements. </span></li>
<li><b>Number of Applications.</b> <span class=regulartext>Applicants
may submit only one application as a PD/PI in response to this FOA. There
is no limit to the number of applications that institutions may submit.</span> </li>
<li><b>Application Materials.</b> See <a
href="#SectionIV1">Section IV.1</a> for application materials. </li>
<li><b>General Information.</b> For general information on SF424
(R&R) Application and Electronic Submission, see these Web sites:
<ul>
<li>SF424 (R&R) Application and Electronic Submission
Information: <a href="//grants.nih.gov/grants/funding/424/index.htm">http://grants.nih.gov/grants/funding/424/index.htm</a></li>
<li>General information on Electronic Submission of Grant
Applications: <a href="http://era.nih.gov/ElectronicReceipt/">http://era.nih.gov/ElectronicReceipt/</a></li>
</ul>
</li>
<li><b>Hearing Impaired.</b> Telecommunications for the hearing
impaired is available at: TTY 301-451-5936. </li>
</ul>
<p class=regulartext><span class=heading2>Table of Contents </span></p>
<hr size=2 width="100%" noshade color="#999999" align=center><p class=regulartext><a
href="#PartI">Part I Overview
Information<br>
</a><br>
<a href="#PartII">Part II Full
Text of Announcement</a><br>
<br>
<a href="#SectionI">Section I.
Funding Opportunity Description</a> <br>
1. Research Objectives <br>
<br>
<a href="#SectionII">Section II.
Award Information</a> <br>
1. Mechanism of Support <br>
2. Funds Available <br>
<br>
<a href="#SectionIII">Section
III. Eligibility Information <br>
</a>1. Eligible Applicants <br>
A. Eligible Institutions <br>
B. Eligible Individuals <br>
2. Cost Sharing or Matching<br>
3. Other - Special Eligibility Criteria <br>
<br>
<a href="#SectionIV">Section IV.
Application and Submission Information</a> <br>
1. Request Application Information <br>
2. Content and Form of Application Submission <br>
3. Submission Dates and Times<br>
A. Submission, Review, and Anticipated Start Dates <br>
1. Letter of Intent <br>
B. Submitting an Application Electronically to the NIH <br>
C. Application Processing <br>
4. Intergovernmental Review <br>
5. Funding Restrictions<br>
6. Other Submission Requirements <br>
<br>
<a href="#SectionV">Section V.
Application Review Information</a> <br>
1. Criteria <br>
2. Review and Selection Process<br>
A. Additional Review Criteria <br>
B. Additional Review Considerations <br>
C. Sharing Research Data <br>
D. Sharing Research Resources <br>
3. Anticipated Announcement and Award Dates <br>
<br>
<a href="#SectionVI">Section VI.
Award Administration Information</a> <br>
1. Award Notices <br>
2. Administrative and National Policy Requirements<br>
A. Cooperative Agreement Terms and Conditions of Award<br>
3. Reporting <br>
<br>
<a href="#SectionVII">Section
VII. Agency Contact(s) <br>
</a>1. Scientific/Research Contact(s) <br>
2. Peer Review Contact(s) <br>
3. Financial/Grants Management Contact(s) <br>
<br>
<a href="#SectionVIII">Section
VIII. Other Information - Required Federal Citations</a> </p>
<p class=regulartext><span class=heading1><a name="PartII"></a>Part II - Full Text of Announcement</span></p>
<hr size=2 width="100%" noshade color="#999999" align=center><p class=regulartext><span class=heading2><a name="SectionI"></a>Section</span><span class=heading2> I. Funding Opportunity
Description</span></p>
<hr size=2 width="100%" noshade color="#999999" align=center><p class=regulartext><span class=heading3>1. Research Objectives</span> </p>
<p class=regulartext>The NIH Director&rsquo;s New Innovator Award is designed to support new
investigators of exceptional creativity who propose highly innovative
approaches that have the potential to produce an unusually high impact <span
class=regulartext>on
significant contemporary problems in biomedical and behavioral research. </span>The term award
is used to mean a grant for conducting research, rather than a reward for past
achievements. Biomedical and behavioral research is defined broadly in this
announcement as encompassing scientific investigations in the biological,
behavioral, clinical, social, physical, chemical, computational, engineering,
and mathematical sciences. The New Innovator Award will emphasize the
importance and potential impact of the scientific problem, the novelty and
innovativeness of the approach and the applicant&rsquo;s potential for creative and
innovative research. Presentation of preliminary data relevant to the project
will be allowed, but is not required. </p>
<p class=regulartext><b>Background </b></p>
<p class=regulartext>The NIH's success depends on the creativity of investigator-initiated
research, much of it supported by the R01 grant mechanism. The <span
class=regulartext>NIH
Director&rsquo;s Pioneer Award (</span><a
href="http://nihroadmap.nih.gov/pioneer/">http://nihroadmap.nih.gov/pioneer/</a>)
was created to provide additional means to identify scientists with ideas that
have the potential for high impact, but may be too novel, span too diverse a
range of disciplines, or be at a stage too early to fare well in the
traditional peer review process. This year, NIH is conducting the fourth
Pioneer Award competition to promote exceptional creativity and innovation in
biomedical research.</p>
<p class=regulartext>The research enterprise of the future also depends on the next
generation of biomedical and behavioral investigators. As part of its
commitment to increasing the success of new investigators, NIH last year
created the NIH Pathway to Independence Award (K99/R00; <a
href="//grants.nih.gov/grants/new_investigators/pathway_independence.htm">http://grants.nih.gov/grants/new_investigators/pathway_independence.htm</a>) to facilitate
the transition from a mentored postdoctoral position to the first
independent research position. </p>
<p class=regulartext>This year, NIH has created the NIH Director&rsquo;s New Innovator Award (<a
href="//grants.nih.gov/grants/new_investigators/innovator_award/">http://grants.nih.gov/grants/new_investigators/innovator_award/</a> ) to support
exceptionally creative new investigators who propose highly innovative
approaches that have the potential to produce an unusually high impact, but
where preliminary data required for a traditional R01 grant may not be
available. This new program is intended to address both the goals of
stimulating the application of innovative research approaches to important
biomedical and behavioral research problems and nurturing unusually creative
investigators at the early stages of their research careers. </p>
<p class=regulartext>This FOA announces the first NIH Director&rsquo;s New Innovator Award
competition for at least 14 awards of up to $1.5 million for a five-year period (an average
annual budget of up to $300,000 direct costs)
plus<span class=regulartext> applicable Facilities</span><span
class=regulartext> and
Administrative costs</span>. Awards will be
made in Fiscal Year 2007. <span class=regulartext>Applicants </span>must hold an
independent research position at a domestic (U.S.) institution<span
class=regulartext> as of
September 20, 2007,</span> must have received their most
recent doctoral degree (e.g., Ph.D., M.D., D.D.S, D.V.M, or equivalent) or
completed their medical internship and residency in 1997 or later,<span
class=regulartext> </span>and must commit at least 30% of their research effort to
the project supported by the New Innovator Award. <span
class=regulartext>Applicants
must meet the definition of new investigator. For </span>the purpose of this FOA, new
investigators are defined as those applicants
who have never been PI on an R01 or equivalent grant (e.g., R23, R29, R37, U01)
or leader of a P01 or center grant peer-reviewed
project. Individuals who are unable to
meet these requirements should not apply. Any request for an exception to the
eligibility requirement of time from last professional degree must be based
upon additional clinical training or unusual circumstances. Requests must be
justified in the Biographical Sketch, and will be considered on a case-by-case
basis. <br>
<br>
See <a href="#SectionVIII">Section
VIII, Other Information - Required Federal Citations</a>, for policies related
to this announcement. <br>
<br>
<a name="SectionII"></a><span class=heading2>Section
II. Award Information</span></p>
<hr size=2 width="100%" noshade color="#999999" align=center><p><span class=heading3>1. Mechanism of Support</span> <br>
<br>
This
Funding Opportunity Announcement (FOA) will use the DP2 award mechanism.
The applicant will be solely responsible for planning, directing, and executing
the proposed project. Applications proposing multiple PIs are not allowed.</p>
<p class=regulartext><span class=heading3>2. Funds Available </span></p>
<p class=regulartext><span class=regulartext>Total funding available for this five-year program is at
least $40 million for the five-year period. It is anticipated that at least 14
awards will be made.</span></p>
<p><span class=heading2><a name="SectionIII"></a>Section III. Eligibility
Information</span></p>
<hr size=2 width="100%" noshade color="#999999" align=center><p class=regulartext><span class=heading3>1. Eligible Applicants</span><br>
<br>
<span class=heading4>1.A.</span><span
class=heading4> Eligible
Institutions </span><br>
<br>
You may submit an application(s) if your institution/organization is a domestic
(U.S.) institution that has any of the following characteristics: </p>
<ul type=disc>
<li class=regulartext>Public/State Controlled Institution of Higher Education </li>
<li class=regulartext>Private Institution of Higher Education </li>
<li class=regulartext>Nonprofit with 501(c)(3) IRS Status (Other than Institution of
Higher Education) </li>
<li class=regulartext>Nonprofit without 501(c)(3) IRS Status (Other than Institution of
Higher Education) </li>
<li class=regulartext>Small Business </li>
<li class=regulartext>For-Profit Organization (Other than Small Business) </li>
<li class=regulartext>State Government </li>
<li class=regulartext>Institutions in U.S.<span
> Territory
or Possession </span></li>
<li class=regulartext>Indian/Native American Tribal Government (Federally Recognized) </li>
<li class=regulartext>Indian/Native American Tribal Government (Other than Federally
Recognized) </li>
<li class=regulartext>Indian/Native American Tribally Designated Organization </li>
<li class=regulartext>Hispanic-serving Institution </li>
<li class=regulartext>Historically Black Colleges and Universities (HBCUs) </li>
<li class=regulartext>Tribally Controlled Colleges and Universities (TCCUs) </li>
<li class=regulartext>Alaska Native- and Native Hawaiian-serving Institution </li>
<li class=regulartext>Regional Organization </li>
<li class=regulartext>Other(s): Eligible agency of the Federal Government; Faith-based or
community-based organization </li>
</ul>
<p class=regulartext>Non-domestic (non-U.S.) entities (Foreign Organizations) are not
eligible to apply.</p>
<p class=regulartext><span class=heading4>1.B. Eligible Individuals </span></p>
<p class=regulartext><span class=regulartext>Applicant PD/PI&rsquo;s </span>must hold an independent research
position at a domestic (U.S.) institution<span class=regulartext> as of September 20, 2007 </span>and must have received their
most recent doctoral degree (e.g., Ph.D., M.D., D.D.S., D.V.M., or equivalent)
or completed their medical internship and residency in 1997 or later. <span class=regulartext>Any r</span>equest for an
exception to the eligibility requirement of time from last professional degree
must be based upon additional clinical training or unusual circumstances.
Requests must be justified in the Biographical Sketch, and will be considered
on a case-by-case basis. For the purpose of this FOA, independent research
position means a position that is held by an investigator who is permitted by
his/her institutional policy to apply for R01 grants, with an appropriate
commitment of facilities to be used for the conduct of the proposed research. </p>
<p class=regulartext><span class=regulartext>Applicants must meet the definition of new investigator.
For </span>the purpose
of this FOA, new investigators are defined as those applicants who have never been PI on an R01 or equivalent grant (e.g.,
R23, R29, R37, U01) or leader of a P01 or center
grant peer-reviewed project. Applicants<span class=regulartext> may submit or have an R01 grant
application pending concurrently with their New Innovator Award application.
The proposed research need not be in a conventional biomedical or behavioral
discipline, but must be relevant to the mission of NIH.</span> This initiative
is to support new investigators proposing new and innovative research with
potential for exceptionally high impact on biomedical problems. <span
class=regulartext>Awardees are
required to commit at least 30% of their research effort to the project
supported by the New Innovator Award. Women and members of groups
underrepresented in biomedical or behavioral research are especially encouraged
to apply. There are no citizenship or residency requirements.</span><span
class=regulartext> </span></p>
<p class=regulartext><span class=heading3>2. Cost Sharing or Matching</span> <br>
<br>
This
program does not require cost sharing as defined in the current <i><a
href="//grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing">NIH
Grants Policy Statement</a></i>.<br>
<br>
<span class=heading3>3.
Other-Special Eligibility Criteria </span><br>
<br>
Not
applicable. </p>
<p class=regulartext><span class=heading2><a name="SectionIV"></a>Section IV. Application and Submission Information</span></p>
<hr size=2 width="100%" noshade color="#999999" align=center><p class=regulartext>To download a SF424 (R&R) Application Package and SF424 (R&R)
Application Guide for completing the SF424 (R&R) forms for this FOA, link
to <a href="http://www.grants.gov/Apply">http://www.grants.gov/Apply/</a> and
follow the directions provided on that Web site.<br>
<br>
A one-time registration for institutions/organizations is required at both: </p>
<ul type=disc>
<li class=regulartext>Grants.gov (<a href="http://www.grants.gov/GetStarted">http://www.grants.gov/GetStarted</a>)
and </li>
<li class=regulartext><span lang=ES-PE>eRA Commons (</span><a
href="http://era.nih.gov/ElectronicReceipt/preparing.htm"><span
lang=ES-PE>http://era.nih.gov/ElectronicReceipt/preparing.htm</span></a><span
lang=ES-PE>)</span><span
> </span></li>
</ul>
<p class=regulartext>PDs/PIs should work with their institutions/organizations to make sure
they are registered in the eRA Commons. </p>
<p class=regulartext>Several additional separate actions are required before an applicant
institution/organization can submit an electronic application, as follows: </p>
<p class=regulartext>1) Organizational/Institutional Registration in <a
href="http://www.grants.gov/GetStarted" title="http://www.grants.gov/GetStarted">Grants.gov/Get
Started</a> </p>
<ul type=disc>
<li class=regulartext><span class=regulartextchar>Your organization will need to
obtain a</span> <a
href="https://eupdate.dnb.com/requestoptions/government/ccrreg/">Data
Universal Number System (DUNS) number</a> <span class=regulartextchar>and
register with the</span> <a
href="http://www.bpn.gov/ccr/scripts/index.html">Central Contractor
Registration (CCR)</a> as part of the Grants.gov registration process. </li>
<li class=regulartext>If your organization does not have a Taxpayer Identification Number
(TIN) or Employer Identification Number (EIN), allow for extra time. A
valid TIN or EIN is necessary for CCR registration. </li>
<li class=regulartext>The CCR also validates the EIN against Internal Revenue Service
records, a step that will take an additional one to two business days. </li>
<li class=regulartext>Direct questions regarding Grants.gov registration to:<br>
<a href="http://grants.gov/CustomerSupport">Grants.gov Customer Support</a><br>
Contact Center Phone: 800-518-4726 <br>
Business Hours: M-F 7:00 a.m. - 9:00 p.m. Eastern Time<br>
Email <a href="/cdn-cgi/l/email-protection#35464045455a4741755247545b41461b525a43"><span class="__cf_email__" data-cfemail="681b1d1818071a1c280f1a09061c1b460f071e">[email&#160;protected]</span></a> </li>
</ul>
<p class=regulartext>2) <a
href="https://commons.era.nih.gov/commons/registration/registrationInstructions.jsp"
title="https://commons.era.nih.gov/commons/registration/registrationInstructions.jsp">Organizational/Institutional
Registration in the eRA Commons</a> </p>
<ul type=disc>
<li class=regulartext>To find out if an organization is already Commons-registered, see
the "<a href="http://era.nih.gov/commons/quick_queries/index.cfm#commons"
title="http://era.nih.gov/commons/quick_queries/index.cfm#commons" Title="Link to Non-U.S. Government Site">List of
Grantee Organizations Registered in NIH eRA Commons. </a> </li>
<li class=regulartext>Direct questions regarding the Commons registration to: <br>
eRA Commons Help Desk<br>
Phone: 301-402-7469 or 866-504-9552 (Toll Free)<br>
TTY: 301-451-5939<br>
Business hours M-F 7:00 a.m. 8:00 p.m. Eastern Time<br>
Email <span class=MsoHyperlink><a href="/cdn-cgi/l/email-protection#41222e2c2c2e2f32012e256f2f28296f262e37"><span class="__cf_email__" data-cfemail="63000c0e0e0c0d10230c074d0d0a0b4d040c15">[email&#160;protected]</span></a> </span></li>
</ul>
<p class=regulartext>3) Project Director/Principal Investigator (PD/PI) Registration in the
NIH eRA Commons: Refer to the <i><a
href="http://era.nih.gov/Docs/COM_UGV2630.pdf"
title="http://era.nih.gov/Docs/COM_UGV2630.pdf">NIH eRA Commons System (COM)
Users Guide</a></i>.<i> </i></p>
<ul type=disc>
<li class=regulartext>The individual designated as the PD/PI on the application must also
be registered in the NIH eRA Commons. It is not necessary for PDs/PIs to
register with Grants.gov. </li>
<li class=regulartext>The PD/PI must hold a PD/PI account in the Commons and must be
affiliated with the applicant organization. This account cannot have any
other role attached to it other than the PD/PI. </li>
<li class=regulartext>This registration/affiliation must be done by the Authorized
Organization Representative/Signing Official (ARO/SO) or his/her designee
who is already registered in the Commons. </li>
<li class=regulartext>Both the PD/PI and AOR/SO need separate accounts in the NIH eRA
Commons since both are authorized to view the application image. </li>
</ul>
<p class=regulartext>Note that if a PD/PI is also an NIH peer reviewer with an Individual
DUNS and CCR registration, that particular DUNS number and CCR registration are
for the individual reviewer only. These are different than any DUNS number and
CCR registration used by an applicant organization. Individual DUNS and CCR
registration should be used only for the purposes of personal reimbursement and
should not be used on any grant applications submitted to the Federal
Government. </p>
<p class=regulartext>Several of the steps of the registration process could take four weeks
or more. Therefore, applicants should immediately check with their business
official to determine whether their organization/institution is already
registered in both <a href="http://www.grants.gov/">Grants.gov</a> and the <a
href="https://commons.era.nih.gov/commons/">Commons</a>. The NIH will accept electronic
applications only from organizations that have completed all necessary
registrations.</p>
<p class=regulartext><span class=heading3><a name="SectionIV1"></a>1. Request Application Information </span><br>
<br>
Applicants
must download the SF424 (R &R) application forms and SF424 (R&R)
Application Guide for this FOA through <a href="http://www.grants.gov/Apply">Grants.gov/Apply</a>.</p>
<p class=regulartext>Note: Only the forms package directly attached to a specific FOA can be
used. You will not be able to use any other SF424 (R&R) forms (e.g., sample
forms, forms from another FOA), although some of the "Attachment"
files may be usable for more than one FOA.<br>
<br>
For further assistance, contact GrantsInfo: Telephone 301-710-0267, Email: <a href="/cdn-cgi/l/email-protection#2f685d4e415b5c664149406f41464701484059"><span class="__cf_email__" data-cfemail="622510030c16112b0c040d220c0b0a4c050d14">[email&#160;protected]</span></a>.<br>
<br>
Telecommunications for the hearing impaired: TTY 301-451-5936.</p>
<p class=regulartext><span class=heading3>2. Content and Form of Application Submission </span></p>
<p class=regulartext>Prepare all applications using the SF424 (R&R) application forms and
in accordance with the SF424 (R&R) Application Guide for this FOA through <u><a
href="http://www.grants.gov/Apply">Grants.gov/APPLY</a>.</u> </p>
<p>The SF424 (R&R) Application Guide
is critical to submitting a complete and accurate application to NIH. There are
fields within the SF424 (R&R) application components that, although not
marked as mandatory, are required by NIH (<i>e.g., the Credential log-in
field of the Research & Related Senior/Key Person Profile component must
contain the PD/PI&rsquo;s assigned eRA Commons User ID</i>). Agency-specific
instructions for such fields are clearly identified in the Application Guide.
For additional information, see Frequently Asked Questions Application
Guide, <a href="http://era.nih.gov/ElectronicReceipt/faq_prepare_app.htm#1">Electronic
Submission of Grant Applications</a>. </p>
<p class=regulartext>The SF424 (R&R) application is comprised of data arranged in
separate components. Some components are required, others are optional. The
forms package associated with this FOA in <u><a
href="http://www.grants.gov/Apply">Grants.gov/APPLY</a> </u>will include all
applicable components, required and optional. A completed application in response
to this FOA will include the following components: </p>
<p class=regulartext><strong>Required Components: </strong><br>
SF424 (R&R) (Cover component) <br>
Research & Related Other Project Information Component<br>
Research & Related Senior/Key Person Profile Component</p>
<p class=regulartext><b>Optional Components:</b><br>
PHS 398 Cover Letter Component </p>
<p class=regulartext>Note: Cover letters should be included only when submitting
changed/corrected or late applications. <b> Do not submit cover letters
with initial submissions.</b></p>
<p class=regulartext><b>The application to be submitted to Grants.gov must
include:</b></p>
<ul>
<li><b>Area of Science Designation:</b> Applicants must choose a
scientific area from the list below. The Area of Science is designated
by entering the two-digit code in the Descriptive Title of Applicant s
Project field on the SF424 Cover Page Component and at the top of the Abstract
page. <b>Only one category may be designated.</b> Category selection will
assist staff in assigning applications to reviewers and is not intended to
limit the areas of biomedical research.<br>
<b><br>
</b></li>
<ul>
<b>Areas of Science:</b><br>
<br>
<li> 01 Behavioral and Social Sciences </li>
<li> 02 Clinical and
Translational Research</li>
<li>03 Instrumentation and
Engineering</li>
<li>04 Molecular Biology </li>
<li> 05 Cellular Biology </li>
<li>06 Chemical Biology</li>
<li>07 Pathogenesis</li>
<li>08 Epidemiology</li>
<li>09 Physiology and Integrative
Systems</li>
<li>10 Quantitative and
Computational Biology <br>
<br>
</li>
</ul>
</li>
<li><b>Effort Commitment:</b> Awardees are required to commit at least 30%
of their research effort to the project supported by the New Innovator
Award. In their list of current and pending support, applicants must
include a statement that, if chosen to receive an award, the applicant will
commit a minimum of 30% of his/her research effort to the project supported by
the New Innovator Award.<br>
<br>
</li>
<li>An <b>abstract</b> of no more than 300 words (no more than one page)
describing the goals of the project. Include the two-digit code for Area
of Science at the top of the Abstract page. This document is uploaded on the
Research & Related Other Project Information Component form, Item 6.)<br>
<br>
</li>
<li>An <b>essay</b> of up to 10 pages that addresses the significance of the
project, what makes the approaches exceptionally innovative, how the applicant
will address risks and challenges, and the applicant&rsquo;s qualifications for this
award. The essay should describe the applicant&rsquo;s view of the major challenges
in biomedical or behavioral research to which he/she can make seminal
contributions. A scientific plan should be provided, written with a level of
detail appropriate for reviewers who are broadly knowledgeable but not who may not be directly involved in the proposed area
of research. The essay should include the following sections within the 10-page
limit: <br>
<br>
<ul>
<li><b>Project description:</b> What is the scientific problem that will be
addressed, and why is this important? What is the likelihood that, if
successful, the result will have a significant impact on the problem? Why is
the planned research uniquely suited to the stated goal of the New Investigator
Award program, rather than a traditional grant mechanism? <br>
<br>
</li>
<li><b>Innovativeness: </b>What are the approaches you plan to take and what
will you do if they are not successful? What is the evidence to demonstrate
that the approaches proposed are significantly more innovative than would
normally be expected, especially for a new investigator<br>
<br>
</li>
<li><b>Investigator qualifications:</b> What evidence supports your claim of
innovativeness and creativity in your research? For example, what qualities do
you have that might demonstrate your inclination to challenge paradigms and
take intellectual risks; your ability to develop unique collaborations, to
integrate diverse sources of information, and to develop novel approaches when
new challenges or opportunities arise; and your persistence in the face of
failure?<br>
</li><br>
</ul>
</li>Preliminary data are allowed, but not
required. Bibliographic citations, figures, and illustrations may be included,
but must fit within the 10-page limit. The essay is uploaded on the
Research & Related Other Project Information Component form, Item 7.</li>
<br>
<br>
<a name=bio id="bio"></a>
<li>A two-page<b> biographical sketch</b>. (Use the format for
biographical sketches shown in Part III of the Application Guide, omitting
Section C, Research Support.) This document is uploaded on the Research
& Related Senior/Key Person Component form. Any request for an exception to
the eligibility requirement of time from last professional degree must be justified
in this section of the application, and must be based upon additional clinical
training or unusual circumstances. Requests will be considered on a
case-by-case basis. <br>
<br>
</li>
<li>A list of <b>current and pending research support</b> from all sources,
including current year direct costs and percent effort devoted to each project.
Applicants must include a statement that, if chosen to receive an award, the
applicant will commit a minimum of 30% of his/her research effort to the
project supported by the New Innovator Award. Applicants must also include in
this section a brief statement of the facilities to be used for the conduct of
the research.</li>
</ul>
<p class=regulartext>(Use the format shown in Part III of
the Application Guide.) This document is uploaded on the Research &
Related Senior/Key Person Component form. </p>
<p>Letters of reference are not required
and will not be accepted.</p>
<p class=regulartext><b>Format specifications for Text (PDF) Attachments:</b> All
attachments must be in PDF format. Follow format specifications for PDF
attachments on page I-17 in the Application Guide.) <b>Fonts:</b>
Use an Arial, Helvetica, Palatino, Linotype, or Georgia typeface, a black font
color, and a font size of 11 points or larger. <b>Type density:</b> Including characters and spaces, must be no more than 15 characters per
inch. Type may be no more than six lines per inch. <b>Page margins:</b>
Use standard paper size (8 x 11). Use at least one-half inch margins
(top, bottom, left, and right) for all pages. Avoid using a two-column
format as it can cause difficulties when reviewing the document electronically. <b>Do not include any information in a header or footer of the
attachment. </b>A header will be self-generated that references the name
of the PD/PI. Page numbers for the footer will be system-generated in the
complete application, with all pages sequentially numbered.</p>
<p class=regulartext><b>Special requirements for completing the SF424 (R&R)
application are in <a href="#SectionIV6">Section IV.6</a>, below.</b></p>
<p class=regulartext>The<b> Budget request </b>is entered only on Line 16a and b, as
described in Section IV.6, below. You may request up to $1.5 million in direct
costs for the five-year budget/project period. Funds may be requested for
personnel, supplies, equipment, sub-contracts, and other allowable costs.
You should estimate the direct costs for each year, and sum them to derive the five-year total.
Only the five-year total should be entered on Line 16a and b and must not
add up to more than $1.5 million. No detailed budget is requested, and
will not be accepted. </p>
<p class=regulartext><span class=heading3>3. Submission Dates and Times</span> <br>
<br>
See <a href="#SectionIV3A">Section
IV.3.A</a> for details. <br>
<br>
<span class=heading4><a name="SectionIV3A"></a>3.A.
Submission, Review, and Anticipated Start Dates </span><br>
Opening Date: April 25, 2007 (Earliest date an application may be
submitted to Grants.gov) <br>
Letters of Intent Receipt Date(s): Not applicable.<br>
<b>NOTE: On time submission requires that applications be successfully
submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant
institution/organization).</b><br>
Application Receipt Date(s): May 22, 2007<br>
Peer Review Date(s): July 2007<br>
Advisory Council to the Director Date(s): August 2007<br>
Earliest Anticipated Start Date(s): September 28, 2007</p>
<p class=heading4>3.A.1. Letter of Intent</p>
<p class=regulartext>A letter of intent is not required and will not be accepted for the
funding opportunity.</p>
<p class=regulartext><span class=heading4>3.B. Submitting an Application Electronically to the NIH </span><br>
<br>
To
submit an application in response to this FOA, applicants should access this
FOA via <a href="http://www.grants.gov/Apply">http://www.grants.gov/Apply</a> and follow steps 1-4. Note: Applications must only be submitted
electronically<b>. PAPER APPLICATIONS WILL NOT BE ACCEPTED. </b></p>
<p class=regulartext><span class=heading4><a name="SectionIV3C"></a>3.C. Application Processing</span><b> <br>
<br>
</b>Applications <b>may</b> be submitted on or after the opening date and <b>must </b>be
successfully received by Grants.gov no later than <b>5:00 p.m. local time</b> (of the
applicant institution/organization) on the application submission/receipt
date(s). (See <a
href="#SectionIV3A">Section
IV.3.A.</a> for all dates.) If an application is not submitted by the receipt
date(s) and time, the application may be delayed in the review process or not
reviewed. </p>
<p>Once an application package has been
successfully submitted through Grants.gov, any errors have been addressed, and
the assembled application has been created in the eRA Commons, the PD/PI and
the Authorized Organization Representative/Signing Official (AOR/SO) have two
business days to view the application image.</p>
<ul type=disc>
<li class=regulartext>If everything is acceptable, no further action is necessary. The
application will automatically move forward for processing by the Division
of Receipt and Referral, Center for Scientific Review, NIH, after two
business days. </li>
<li class=regulartext>Prior to the submission deadline, the AOR/SO can Reject the
assembled application and submit a changed/corrected application within
the two-day viewing window. This option should be used if the AOR/SO
determines that warnings should be addressed. Reminder: warnings do not
stop further application processing. If an application submission results
in warnings (but no errors) it will automatically move forward after two
business days if no action is taken. Please remember that some
warnings may not be applicable or may need to be addressed after
application submission. </li>
<li class=regulartext>If the two-day window falls after the submission deadline, the
AOR/SO will have the option to Reject the application if, due to an eRA
Commons or Grants.gov system issue, the application does not correctly
reflect the submitted application package (e.g., some part of the
application was lost or didn t transfer correctly during the submission
process). The AOR/SO should first contact the <a
href="http://ithelpdesk.nih.gov/eRA/">eRA Commons Helpdesk</a> to confirm
the system error, document the issue, and determine the best course of
action. NIH will not penalize the applicant for an eRA Commons or Grants.gov system issue. </li>
<li class=regulartext>If the AOR/SO chooses to Reject the image after the submission
deadline for a reason other than an eRA Commons or Grants.gov system
failure, a changed/corrected application still can be submitted but it
will be subject to the <a
href="//grants.nih.gov/grants/guide/notice-files/NOT-OD-05-030.html">NIH
late policy</a> guidelines and may not be accepted. The reason for this
delay should be explained in the cover letter attachment. </li>
<li class=regulartext>Both the AOR/SO and PD/PI will receive e-mail notifications when
the application is rejected or the application automatically moves forward
in the process after two days. </li>
</ul>
<p class=regulartext>Upon receipt, applications will be evaluated for completeness and
eligibility by NIH staff. Incomplete applications will not be reviewed. <b><br>
<br>
</b>There will be an acknowledgement of receipt of applications from Grants.gov
and the <a href="https://commons.era.nih.gov/commons/">Commons</a><a
href="https://commons.era.nih.gov/commons/"></a>. Information related to the
assignment of an application to a Scientific Review Group is also in the
Commons. </p>
<p class=regulartext><b>Note: Since email can be unreliable, it is the
responsibility of the applicant to check periodically on their application
status in the Commons.</b></p>
<p class=regulartext><span class=heading3>4. Intergovernmental Review </span><br>
<br>
This
initiative is not subject to <em><a
href="//grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part9.htm#_Toc54600164">intergovernmental
review</a>.</em><b> </b><br>
<br>
<span class=heading3><a name="SectionIV5"></a>5.
Funding Restrictions </span><br>
<br>
All
NIH awards are subject to the terms and conditions, cost principles, and other
considerations described in the <i><a
href="http://grants1.nih.gov/grants/policy/nihgps_2003/index.htm">NIH Grants
Policy Statement</a></i>. <br>
<br>
<span class=heading3><a name="SectionIV6"></a>6.
Other Submission Requirements </span><br>
<br>
<span class=regulartextbold1><b>PD/PI Credential (e.g., Agency Login)</b></span></p>
<p>The NIH requires the PD/PI to fill in
his/her Commons User ID in the PROFILE Project Director/Principal
Investigator section, Credential log-in field of the Research & Related
Senior/Key Person Profile component. The applicant organization must include
its DUNS number in its Organization Profile in the eRA Commons. This DUNS
number must match the DUNS number provided at CCR registration with Grants.gov.
For additional information, see Registration FAQs Important Tips -- <a
href="http://era.nih.gov/ElectronicReceipt/preparing.htm#4c">Electronic
Submission of Grant Applications</a>. </p>
<p class=regulartext><span class=regulartextbold1><b>Organizational DUNS</b></span></p>
<p class=regulartext>The applicant organization must include its DUNS number in its
Organization Profile in the eRA Commons. This DUNS number must match the DUNS
number provided at CCR registration with Grants.gov. For additional information,
see Frequently Asked Questions Application Guide, <a
href="http://era.nih.gov/ElectronicReceipt/faq_prepare_app.htm#1">Electronic
Submission of Grant Applications</a>. </p>
<p class=regulartext><b>Research Plan Component Sections</b></p>
<p class=regulartext>Not applicable.</p>
<p class=regulartext><b>All application instructions outlined in the SF 424
(R&R) Application Guide are to be followed, incorporating Just-in-Time
information concepts, with the following additional requirements for New
Innovator Award applications. Applications that do not conform to the
specific instructions detailed below will not be reviewed. </b></p>
<p class=regulartext><b>1. SF424 (R&R) (COVER COMPONENT): </b><strong>Enter title of
applicant&rsquo;s project. DO NOT include the two-digit Area of Science code at the
beginning of this title. This title </strong><strong>is for use solely by the
applicant for tracking the application through the Grants.gov submission
process. It has different length requirements and
does not need to match the full title in Item 11 below.</strong></p>
<p class=regulartext>Fill out each section using the instructions below. Note that
items that are starred (*) in the application are mandatory.</p>
<table border=1 cellspacing=0 cellpadding=0
>
<tr>
<td valign=top><p align=center><b><span
>Item Number and Title</span></b></p></td>
<td valign=top><p align=center><b><span
>Instructions</span></b></p></td>
</tr>
<tr>
<td valign=top><p><b>1. Type of Submission</b></p></td>
<td valign=top><p>Check Application . (See Section IV. 3C for
information on Changed/Corrected Applications.) </p></td>
</tr>
<tr>
<td valign=top><p><b>2. Date Submitted</b></p></td>
<td valign=top><p>Enter date in this format: mm/dd/yyyy.</p></td>
</tr>
<tr>
<td valign=top><p><b>Applicant Identifier </b></p></td>
<td valign=top><p>Optional for applicant institution use</p></td>
</tr>
<tr>
<td valign=top><p><b>3. Date Received by State</b></p></td>
<td valign=top><p>Leave blank.</p></td>
</tr>
<tr>
<td valign=top><p><b> State Application Identifier</b></p></td>
<td valign=top><p>Leave blank</p></td>
</tr>
<tr>
<td valign=top><p><b>4. Federal Identifier</b></p></td>
<td valign=top><p>For initial submission leave blank; for
Changed/Corrected submissions, enter Grants.gov tracking number of initial
submission</p></td>
</tr>
<tr>
<td valign=top><p><b>5. Applicant Information</b></p></td>
<td valign=top><p>Enter information for <b>Applicant</b> <b>Organization</b></p></td>
</tr>
<tr>
<td valign=top><p><b> Organizational DUNS</b></p></td>
<td valign=top><p>Must match the number entered in the eRA Commons
Institutional Profile for the applicant organization.</p></td>
</tr>
<tr>
<td valign=top><p><b>Legal Name</b></p></td>
<td valign=top><p>Enter the legal name of the <b>Applicant Organization</b></p></td>
</tr>
<tr>
<td valign=top><p><b> Department</b></p></td>
<td valign=top><p>Enter the name of the primary organizational
department, service, laboratory, or equivalent level within the organization
that will undertake the assistance activity.</p></td>
</tr>
<tr>
<td valign=top><p><b>Division</b></p></td>
<td valign=top><p>Enter the name of the primary organizational division,
office, or major subdivision that will undertake the assistance activity.</p></td>
</tr>
<tr>
<td valign=top><p><b>Address</b></p></td>
<td valign=top><p>Enter the address for the <b>Applicant Organization</b></p></td>
</tr>
<tr>
<td valign=top><p><b>Person to be contacted on matters involving this application</b></p></td>
<td valign=top><p>Enter information for the <b>Administrative or Business
Official</b>, not the PD/PI. This person is the individual to be
notified if additional information is needed and/or if an award is made.</p></td>
</tr>
<tr>
<td valign=top><p><b>6. Employer Identification Number (EIN or TIN)</b></p></td>
<td valign=top><p>Enter the EIN or TIN as assigned by the Internal
Revenue Service. If you have a 12-digit EIN established for grant awards
from NIH or other PHS agencies, enter all 12 digits.</p></td>
</tr>
<tr>
<td valign=top><p><b>7. Type of Applicant</b></p></td>
<td valign=top><p>This information is for the <b>Applicant Organization</b>,
not a specific individual.</p></td>
</tr>
<tr>
<td valign=top><p><b>8. Type of Application</b></p></td>
<td valign=top><p>Must be New </p></td>
</tr>
<tr>
<td valign=top><p><b>9. Name of Federal Agency</b></p></td>
<td valign=top><p>Pre-populated</p></td>
</tr>
<tr>
<td valign=top><p><b>10. Catalog of Federal Domestic Assistance Number</b></p></td>
<td valign=top><p>Pre-populated: 93.310 Trans-NIH Research
Support</p></td>
</tr>
<tr>
<td valign=top><p><b>11. Descriptive Title of Applicant&rsquo;s Project</b></p></td>
<td valign=top><p>Limited to 81 characters, including spaces and
punctuation. IN FRONT OF TITLE, enter two-digit code for Area of Science,
followed by a hyphen. Enter two digits only, no letters or spaces between
code, hyphen and title (e.g., 02-Cure of the Common Cold). Only one area may
be selected.</p>
<ul>
<li>01 Behavioral and Social Sciences </li>
<li>02 Clinical and Translational Research</li>
<li>03 Instrumentation and Engineering</li>
<li>04 Molecular Biology</li>
<li>05 Cellular Biology </li>
<li>06 Chemical Biology</li>
<li>07 Pathogenesis</li>
<li>08 Epidemiology</li>
<li>09 Physiology and Integrative Systems</li>
<li>10 Quantitative and Computational Biology<br>
<br>
</li>
</ul></td>
</tr>
<tr>
<td valign=top><p><b>12. Areas Affected by Project</b></p></td>
<td valign=top><p>Enter n/a for not applicable</p></td>
</tr>
<tr>
<td valign=top><p><b>13. Proposed Project</b></p></td>
<td valign=top><p>Enter start date: <b>09/28/2007</b>; Enter end date: <b>08/31/2012</b></p></td>
</tr>
<tr>
<td valign=top><p><b>14. Congressional Districts of <br>
a. Applicant</b></p></td>
<td valign=top><p>Enter the Congressional District in the format: 2
character State Abbreviation 3 character District Number.
Examples: CA-005 for California&rsquo;s 5<sup>th</sup> district, CA-012 for California&rsquo;s 12<sup>th</sup> district. To locate your Congressional district,
visit the Grants.gov Web site. </p></td>
</tr>
<tr>
<td valign=top><p><b>Congressional Districts
of <br>
b. Project</b></p></td>
<td valign=top><p>Enter the Congressional District in the format: 2
character State Abbreviation 3 character District Number.
Examples: CA-005 for California&rsquo;s 5<sup>th</sup> district, CA-012 for California&rsquo;s 12<sup>th</sup> district. If all districts for a state are affected,
enter all for the district number. Example: MD-all for all
congressional districts in Maryland. If nationwide (all districts in
all states) enter US-all. To locate your Congressional district, visit
the Grants.gov Web site. Attach an additional list of Project
Congressional Districts on page 2 (Item 21), if needed.</p></td>
</tr>
<tr>
<td valign=top><p><b>15. Project Director/Principal Investigator
Contact Information</b></p></td>
<td valign=top><p>Enter information for <b>PD/PI</b> here.</p></td>
</tr>
<tr>
<td valign=top><p><b>16. Estimated Project Funding<br>
a. Total Estimated Project Funding</b></p></td>
<td valign=top><p>Enter up to <b>$1,500,000</b></p></td>
</tr>
<tr>
<td valign=top><p><b> b. Total Federal &
Non-Federal Funds</b></p></td>
<td valign=top><p>Enter up to <b>$1,500,000</b></p></td>
</tr>
<tr>
<td valign=top><p><b> c. Estimated Program Income</b></p></td>
<td valign=top><p>Enter 0 (Zero)</p></td>
</tr>
<tr>
<td valign=top><p><b>17. Is Application Subject to Review by State
Executive Order 12372 Process?</b></p></td>
<td valign=top><p>Check No </p></td>
</tr>
<tr>
<td valign=top><p><b>18. Statement and Signatures (Complete
Certification)</b></p></td>
<td valign=top><p>Read statement in box 18. Check I agree box to
provide required certifications and assurances. This field is required.</p></td>
</tr>
<tr>
<td valign=top><p><b>19. Authorized Representative (Signing Official)</b></p></td>
<td valign=top><p>Completed by the AOR/SO.</p></td>
</tr>
<tr>
<td valign=top><p><b>20. Pre-Application</b></p></td>
<td valign=top><p>Leave Blank.</p></td>
</tr>
<tr>
<td valign=top><p><b>21. List of Project Congressional Districts</b></p></td>
<td valign=top><p>See item 14b above.</p></td>
</tr>
</table>
<p><b>2. RESEARCH & RELATED OTHER PROJECT INFORMATION
COMPONENT: <br>
<br>
</b>Fill out each
section using the instructions below. Note that items that are starred
(*) in the application are mandatory.</p>
<table border=1 cellspacing=0 cellpadding=0
>
<tr>
<td valign=top><p align=center><b><span
>Item Number and Title</span></b></p></td>
<td valign=top><p align=center><b><span
>Instructions</span></b></p></td>
</tr>
<tr>
<td valign=top><p><b>1. Are Human Subjects Involved?</b></p></td>
<td valign=top><p>Check <b>No</b> (Note: This information will be
requested at the time of award)</p></td>
</tr>
<tr>
<td valign=top><p><b>2. Are Vertebrate Animals Used?</b></p></td>
<td valign=top><p>Check <b>No</b> (Note: This information will be
requested at the time of award)</p></td>
</tr>
<tr>
<td valign=top><p><b>3. 4. </b></p></td>
<td valign=top><p>Answer as appropriate.</p></td>
</tr>
<tr>
<td valign=top><p><b>5. a. Activities Outside U.S./International <br>
Collaborators</b></p></td>
<td valign=top><p>Answer as appropriate. </p></td>
</tr>
<tr>
<td valign=top><p><b>5.b. Identify Countries</b></p></td>
<td valign=top><p class=instruction><span
>Enter
the countries with which international cooperative activities are involved.</span></p></td>
</tr>
<tr>
<td valign=top><p><b>5.c. Optional Explanation</b></p></td>
<td valign=top><p><b>Do not use. </b> </p></td>
</tr>
<tr>
<td valign=top><p><b>6. Project Summary/Abstract</b></p></td>
<td valign=top><p>Attach <b>abstract. </b>(<b>Maximum of 300 words
[no more than one page]</b>; PDF format)<b> </b></p></td>
</tr>
<tr>
<td valign=top><p><b>7. Project Narrative</b></p></td>
<td valign=top><p>Attach <b>essay</b> (<b>Maximum of ten pages</b>; PDF
format)</p></td>
</tr>
<tr>
<td valign=top><p><b>8. Bibliography & References Cited</b></p></td>
<td valign=top><p><b>Do not use.</b> If you choose to include figures or
bibliographic citations, they must be included in the essay, subject to the
10-page limit.</p></td>
</tr>
<tr>
<td valign=top><p><b>9. Facilities & Other Resources</b></p></td>
<td valign=top><p><b>Do not use.</b></p></td>
</tr>
<tr>
<td valign=top><p><b>10. Equipment</b></p></td>
<td valign=top><p><b>Do not use.</b></p></td>
</tr>
<tr>
<td valign=top><p><b>11. Other Attachments</b></p></td>
<td valign=top><p><b>Do not use.</b></p></td>
</tr>
</table>
<p class=regulartext><b>Note: Applications
found not to comply with the page limit requirements may lead to rejection of
the application during agency validation or delay in the review process.</b></p>
<p class=regulartext><b>3.
SF424 (R & R) SENIOR/KEY PERSON PROFILE COMPONENT:</b></p>
<p>Fill out each section using the instructions below.
Note that items on the application that are starred (*) are mandatory.</p>
<p>Complete items only for Project Director/Principal
Investigator.<b> Do not submit profiles for other senior/key personnel.</b></p>
<table border=1 cellspacing=0 cellpadding=0
>
<tr>
<td valign=top><p align=center><b><span
>Item Title</span></b></p></td>
<td valign=top><p align=center><b><span
>Instructions</span></b></p></td>
</tr>
<tr>
<td valign=top><p><b>Credential, e.g., agency login</b></p></td>
<td valign=top><p>Enter PD/PI&rsquo;s <b>eRA/Common&rsquo;s UserName</b></p></td>
</tr>
<tr>
<td valign=top><p><b>Project Role</b></p></td>
<td valign=top><p>Prefilled</p></td>
</tr>
<tr>
<td valign=top><p><b>Other Project Role Category</b></p></td>
<td valign=top><p>Leave blank</p></td>
</tr>
<tr>
<td valign=top><p><b>Attach Biographical Sketch</b></p></td>
<td valign=top><p>Attach <b>biographical sketch</b> here <b>(two-page
maximum</b>, PDF format). Use the form shown in the URL in Section
4.5.2 of the Application Guide, omitting Section C, Research Support (see
below).</p></td>
</tr>
<tr>
<td valign=top><p><b>Attach Current & Pending Support</b></p></td>
<td valign=top><p>Attach a <b>list of Current and Pending Support</b> here (PDF format). Use the form shown in the URL in Section 4.5.2 of the
Application Guide. Be sure to include statement affirming that you will
devote at least 30% of research effort to New Innovator Award project. Also,<span
> include in this section a brief
statement of the facilities to be used for the conduct of the research.</span></p></td>
</tr>
<tr>
<td valign=top><p><b>Profile Senior Key Person 1</b></p></td>
<td valign=top><p><b>Do not use. </b></p></td>
</tr>
<tr>
<td valign=top><p><b>Additional Senior/Key Person Profile(s)</b></p></td>
<td valign=top><p><b>Do not use.</b></p></td>
</tr>
<tr>
<td valign=top><p><b>Additional Biographical Sketch(es) (Senior/Key Person)</b></p></td>
<td valign=top><p><b>Do not use.</b></p></td>
</tr>
<tr>
<td valign=top><p><b>Additional Current and Pending Support(s)</b></p></td>
<td valign=top><p><b>Do not use.</b></p></td>
</tr>
</table>
<p class=regulartext><b>Note: Applications
found not to comply with the page limit requirements may lead to rejection of
the application during agency validation or delay in the review process.</b></p>
<p class=regulartext><b>4. PHS 398 Cover Letter File (Optional)</b>:</p>
<p class=regulartext>Cover letters should be included only when submitting Changed/Corrected
or late applications. <b>Do not submit cover letters for initial
submissions.</b> The cover letter should contain <b>only</b> the
following information:</p>
<p class=regulartext>1. PD/PI name</p>
<p class=regulartext>2. Funding Opportunity
Title: 2007 NIH Director&rsquo;s New Innovator Award Program (DP2)</p>
<p class=regulartext>3. For late applications, include
an explanation of the delay. (See Late Application Policy in Section
2.14 of the Application Guide.)</p>
<p class=regulartext>4. For Changed/Corrected
Applications after the submission deadline, include an explanation of the
reason for the Changed/Corrected Application.</p>
<p class=regulartext>(See full instructions for submitting the Cover Letter Component in
Section 5.2 of the Application Guide. Note: Items 3 6 of the
Guide do not apply to New Innovator Award applications.)</p>
<p class=regulartext><b>LETTERS OF REFERENCE:</b> </p>
<p class=regulartext>Letters of
reference are not required and will not be accepted.</p>
<p><span class=heading3>Plan for Sharing Research Data</span> </p>
<p class=regulartext>Not applicable<br>
<br>
<span class=heading3>Sharing
Research Resources</span> </p>
<p class=regulartext>Not applicable</p>
<p class=regulartext><span class=heading2><a name="SectionV"></a>Section V. Application Review Information</span></p>
<hr size=2 width="100%" noshade color="#999999" align=center><p class=regulartext><span class=heading3>1. Criteria</span> </p>
<p>Only the review criteria described
below will be considered in the review process.<b><br>
<br>
</b><span class=heading3>2. Review and Selection Process </span><br>
<br>
Applications that are complete and responsive to the FOA will be
evaluated electronically by a specially constituted, multidisciplinary group of
outside experts. The Advisory Committee to the Director (ACD), NIH, will
conduct the second level of review. </p>
<p>The review criteria will emphasize the
importance and potential impact of the scientific problem in biomedical and
behavioral research, the novelty and innovativeness of the approach, and
evidence of the applicant&rsquo;s potential for creative and innovative research as a
new investigator. Also, reviewers will consider appropriateness of the New Innovator
Award grant mechanism to support the proposed project. Specifically,
reviewers will evaluate:</p>
<ul>
<li><b>The scientific problem to be addressed:</b><span
> The
biomedical or behavioral significance/importance of the problem; the
likelihood that, if successful, the project will have a truly significant
impact on this problem. </span></li>
<li><b>Innovativeness of the research proposed:</b> Evidence that the
proposed approaches are significantly more innovative and creative than would
normally be expected, especially for a new investigator, and evidence that the
investigator has considered and addressed the potential risks and challenges. </li>
<li><b>Investigator qualifications:</b><span
> Evidence of the investigator&rsquo;s creativity and potential for
innovation, and the commitment of the investigator to devote 30% or more
of his/her research effort on the New Innovator Award project.</span></li>
</ul>
<p class=regulartext>The following will be considered in making funding decisions: </p>
<ul type=disc>
<li class=regulartext>Scientific merit of the proposed project as determined by peer
review </li>
<li class=regulartext>Availability of funds </li>
<li class=regulartext>Relevance to program priorities </li>
</ul>
<p class=regulartext>The Director, NIH, will make the final selection of awardees based on
the evaluations by the outside experts, the recommendations of the ACD, and
programmatic considerations. </p>
<p class=regulartext>Final selections will be publicly announced, and awards made, by the end
of September 2007. </p>
<p class=regulartext><span class=heading4>2.A. Additional Review Criteria: </span><br>
<br>
<b>Protection of Human
Subjects from Research Risk:</b> The involvement
of human subjects and protections from research risk relating to their
participation in the proposed research will be assessed. See the Human
Subjects Sections of the PHS398 Research Plan component of the SF424
(R&R).. <br>
<br>
<b>Inclusion of Women, Minorities and Children in Research: </b>The adequacy of
plans to include subjects from both genders, all racial and ethnic groups (and
subgroups), and children as appropriate for the scientific goals of the
research will be assessed. Plans for the recruitment and retention of subjects
will also be evaluated. See the Human Subjects Sections of the PHS398 Research
Plan component of the SF424 (R&R)<br>
<br>
<b>Care and Use of Vertebrate Animals in Research:</b> If vertebrate animals
are to be used in the project, the adequacy of the plans for their care and use
will be assessed. See the Other Research Plan Sections of the PHS398 Research
Plan component of the SF424 (R&R). <br>
<br>
<b>Biohazards:</b> If materials or procedures are proposed that are potentially
hazardous to research personnel and/or the environment, determine if the
proposed protection is adequate. </p>
<p class=regulartext><span class=heading4>2. B. Additional Review Considerations </span><br>
<br>
<span class=regulartextChar1><b>Budget and Period of Support: </b></span>The reasonableness of the proposed
budget in relation to the proposed research may be assessed by the reviewers.
The priority score will not be affected by the evaluation of the budget. </p>
<p class=regulartext><span class=heading4>2.C. Sharing Research Data</span> <br>
<br>
Not
applicable. </p>
<p class=regulartext><span class=heading4>2.D. Sharing Research Resources</span> <br>
<br>
Not
applicable. </p>
<p class=regulartext><span class=heading3>3. Anticipated Announcement and Award Dates</span> <br>
<br>
Awardees
will be notified in September, 2007, and
awards will begin September 28, 2007. <br>
<br>
<span class=heading2><a name="SectionVI"></a>Section
VI. Award Administration Information</span></p>
<hr size=2 width="100%" noshade color="#999999" align=center>
<p class=regulartext><span class=heading3>1. Award Notices </span><br>
<br>
If the application is under consideration for funding,
"just-in-time" information will be requested from the applicant. For
details, applicants may refer to the <em><a
href="//grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm">NIH
Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards,
Subpart A: General</a>.</em> </p>
<p class=regulartext>A formal notification in the form of a Notice of Award (NoA) will be
provided to the applicant organization. The NoA signed by the grants management
officer is the only authorizing document. Once all administrative and
programmatic issues have been resolved, the NoA will be generated via email notification
from the awarding component to the grantee business official. <br>
<br>
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. See <a
href="#SectionIV5">Section IV.5.</a>,
Funding Restrictions. <br>
<br>
<span class=heading3>2.
Administrative and National Policy Requirements </span><br>
<br>
All
NIH grant and cooperative agreement awards include the <i>NIH Grants Policy
Statement</i> as part of the NoA. For these terms of award, see the <a
href="//grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm"><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/policy/nihgps_2003/NIHGPS_part9.htm">Part
II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions
for Specific Types of Grants, Grantees, and Activities</a>. </p>
<p class=regulartext>The following terms and conditions will be incorporated into the NoA and
will be provided to the PD/PI and the appropriate institutional official at the
time of award:</p>
<p>2a. When issuing
statements, press releases, and other documents describing projects or programs
funded as a NIH Director&rsquo;s New Innovator Awards, please use the
following acknowledgement: "This work was funded by the National
Institutes of Health through the NIH Director's New Innovator Award Program, grant
number DP2-OD-xxxxxx. Information on the New Innovator Award Program is at <a
href="https://owa.nih.gov/exchweb/bin/redir.asp?URL=http://grants.nih.gov/grants/new_investigators/innovator_award/"
target="_blank">http://grants.nih.gov/grants/new_investigators/innovator_award/</a>. </p>
<p>2b. As indicated in the
FOA, awardees are expected to commit at least 30% of their research effort to
the project supported by the New Innovator Award.</p>
<p class=regulartext><span class=heading3>3. Reporting </span><br>
<br>
Awardees
will be required to submit a scientific progress report on June 1 of each year
describing the progress made under this grant and to submit a final progress
report, Final Invention Statement, and Financial Status Report at the end of
the budget/project period. <br>
<br>
<span class=heading2><a name="SectionVII"></a>Section
VII. Agency Contacts </span></p>
<hr size=2 width="100%" noshade color="#999999" align=center>
<p class=regulartext>We encourage your inquiries
concerning this funding opportunity and welcome the opportunity to answer
questions from potential applicants. Direct inquiries, preferably by e-mail,
to:<br>
<br>
<span class=heading3>1. Scientific/Research Contact:</span></p>
<p class=regulartext>Judith H. Greenberg, Ph.D.<br>
Director, Division of Genetics and Developmental Biology<br>
National Institute of General Medical Sciences<br>
National Institutes of Health<br>
Building 45, Room 2As25, MSC 6200<br>
Bethesda, Maryland 20892-6200<br>
Phone: 301-594-4469<br>
Email: <a href="/cdn-cgi/l/email-protection#234d46544a4d4d4c5542574c51634d4a4b0d444c55"><span class="__cf_email__" data-cfemail="caa4afbda3a4a4a5bcabbea5b88aa4a3a2e4ada5bc">[email&#160;protected]</span></a> </p>
<p class=regulartext><span class=heading3>2. Peer Review Contact:</span></p>
<p class=regulartext>Judith H. Greenberg, Ph.D.<br>
Director, Division of Genetics and Developmental Biology<br>
National Institute of General Medical Sciences<br>
National Institutes of Health<br>
Building 45, Room 2As25, MSC 6200<br>
Bethesda, Maryland 20892-6200<br>
Phone: 301-594-4469<br>
Email: <a href="/cdn-cgi/l/email-protection#aac4cfddc3c4c4c5dccbdec5d8eac4c3c284cdc5dc"><span class="__cf_email__" data-cfemail="a3cdc6d4cacdcdccd5c2d7ccd1e3cdcacb8dc4ccd5">[email&#160;protected]</span></a> </p>
<p class=regulartext><span class=heading3>3. Financial/Grants Management Contact: </span></p>
<p class=regulartext>Marcia
F. Cohn<br>
Grants Management Officer<br>
National Institute of General Medical Sciences<br>
National Institutes of Health<br>
Building 45, MSC 6200<br>
Bethesda, Maryland 20892-6200<br>
Phone: 301-594-3918<br>
<span lang=FR>FAX: 301-480-2554</span><br>
<span lang=FR>Email: </span><a href="/cdn-cgi/l/email-protection#5f3c303731321f323e36337131363771383029"><span lang=FR><span class="__cf_email__" data-cfemail="73101c1b1d1e331e121a1f5d1d1a1b5d141c05">[email&#160;protected]</span></span></a><span
lang=FR> </span></p>
<p>Information
about the New Innovator Awards is at <a
href="//grants.nih.gov/grants/new_investigators/innovator_award/">http://grants.nih.gov/grants/new_investigators/innovator_award/</a>. </p>
<p>Please
see the Frequently Asked Questions (FAQs) on the New Innovator web site at <a
href="//grants.nih.gov/grants/new_investigators/innovator_award/faq.htm">http://grants.nih.gov/grants/new_investigators/innovator_award/faq.htm</a> </p>
<p class=regulartext><span class=heading2><a name="SectionVIII"></a>Section VIII. Other Information</span></p>
<hr size=2 width="100%" noshade color="#999999" align=center><p><span class=heading3>Required Federal Citations </span><br>
<br>
<b>Use
of Animals in Research:</b> <br>
Recipients of PHS support for activities involving live, vertebrate animals
must comply with PHS Policy on Humane Care and Use of Laboratory Animals (<a
href="//grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf">http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf</a>)
as mandated by the Health Research Extension Act of 1985 (<a
href="//grants.nih.gov/grants/olaw/references/hrea1985.htm">http://grants.nih.gov/grants/olaw/references/hrea1985.htm</a>),
and the USDA Animal Welfare Regulations (<a
href="http://www.nal.usda.gov/awic/legislat/usdaleg1.htm">http://www.nal.usda.gov/awic/legislat/usdaleg1.htm</a>)
as applicable. <br>
<br>
<b>Human Subjects Protection:</b> <br>
Federal regulations (45 CFR 46) require that applications and proposals
involving human subjects must be evaluated with reference to the risks to the
subjects, the adequacy of protection against these risks, the potential
benefits of the research to the subjects and others, and the importance of the
knowledge gained or to be gained (<a href="https://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm">http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm</a>). <br>
<br>
<b>Data and Safety Monitoring Plan:</b> <br>
Data and safety monitoring is required for all types of clinical trials,
including physiologic toxicity and dose-finding studies (phase I); efficacy
studies (Phase II); efficacy, effectiveness and comparative trials (Phase III).
Monitoring should be commensurate with risk. The establishment of data and
safety monitoring boards (DSMBs) is required for multi-site clinical trials
involving interventions that entail potential risks to the participants ( NIH
Policy for Data and Safety Monitoring, <i>NIH Guide for Grants and Contracts</i>, <a href="//grants.nih.gov/grants/guide/notice-files/not98-084.html">http://grants.nih.gov/grants/guide/notice-files/not98-084.html</a>). </p>
<p class=regulartext><b>Sharing Research Data:</b> </p>
<p class=regulartext>Not applicable.<br>
<br>
<b>Access to Research Data through the Freedom of
Information Act:</b> <br>
The Office of Management and Budget (OMB) Circular A-110 has been revised to
provide access to research data through the Freedom of Information Act (FOIA)
under some circumstances. Data that are (1) first produced in a project that is
supported in whole or in part with Federal funds and (2) cited publicly and
officially by a Federal agency in support of an action that has the force and
effect of law (i.e., a regulation) may be accessed through FOIA. It is
important for applicants to understand the basic scope of this amendment. NIH
has provided guidance at <a
href="//grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm">http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm</a>.
Applicants may wish to place data collected under this funding opportunity in a
public archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the application.
In addition, applicants should think about how to structure informed consent
statements and other human subjects procedures given the potential for wider
use of data collected under this award. <br>
<br>
<b>Sharing of Model Organisms:</b> <br>
NIH is committed to support efforts that encourage sharing of important
research resources including the sharing of model organisms for biomedical
research (see <a
href="//grants.nih.gov/grants/policy/model_organism/index.htm">http://grants.nih.gov/grants/policy/model_organism/index.htm</a>).
At the same time the NIH recognizes the rights of grantees and contractors to
elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh Dole Act (see the <i><a
href="//grants.nih.gov/grants/policy/nihgps_2003/index.htm">NIH Grants
Policy Statement</a></i>. A model organism sharing plan will be required if an
award is to be made.</p>
<p class=regulartext><b>Inclusion of Women And Minorities in Clinical Research:</b> <br>
It is the policy of the NIH that women and members of minority groups and their
sub-populations must be included in all NIH-supported clinical research
projects unless a clear and compelling justification is provided indicating
that inclusion is inappropriate with respect to the health of the subjects or
the purpose of the research. This policy results from the NIH Revitalization
Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing
clinical research should read the "NIH Guidelines for Inclusion of Women
and Minorities as Subjects in Clinical Research (<a
href="//grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html">http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html</a>);
a complete copy of the updated Guidelines is available at <a
href="//grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm">http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm</a>.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the SF424 (R&R) application; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a) all
applications or proposals and/or protocols must provide a description of plans
to conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and b)
investigators must report annual accrual and progress in conducting analyses,
as appropriate, by sex/gender and/or racial/ethnic group differences. <br>
<br>
<b>Inclusion of Children as Participants in Clinical Research:</b> <br>
The NIH maintains a policy that children (i.e., individuals under the age of
21) must be included in all clinical research, conducted or supported by the
NIH, unless there are scientific and ethical reasons not to include them. <br>
<br>
All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines" on the inclusion of children as
participants in research involving human subjects (<a
href="//grants.nih.gov/grants/funding/children/children.htm">http://grants.nih.gov/grants/funding/children/children.htm</a>). <br>
<br>
<b>Required Education on the Protection of Human Subject Participants:</b> <br>
NIH policy requires education on the protection of human subject participants
for all investigators submitting NIH applications for research involving human
subjects and individuals designated as key personnel. The policy is available
at <a href="//grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html">http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html</a>. <br>
<br>
<b>Human Embryonic Stem Cells (hESC):</b> <br>
Criteria for federal funding of research on hESCs can be found at <a
href="http://stemcells.nih.gov/index.asp">http://stemcells.nih.gov/index.asp</a> and at <a
href="//grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html">http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html</a>.
Only research using hESC lines that are registered in the NIH Human Embryonic
Stem Cell Registry will be eligible for Federal funding (<a
href="http://escr.nih.gov/">http://escr.nih.gov</a>). It is the responsibility
of the applicant to provide in the project description and elsewhere in the
application as appropriate, the official NIH identifier(s) for the hESC line(s)
to be used in the proposed research. Applications that do not provide this
information will be returned without review. <br>
<br>
<b>NIH Public Access Policy:</b> <br>
NIH-funded investigators are requested to submit to the NIH manuscript
submission (NIHMS) system (<a href="http://www.nihms.nih.gov">http://www.nihms.nih.gov</a>)
at PubMed Central (PMC) an electronic version of the author's final manuscript
upon acceptance for publication, resulting from research supported in whole or
in part with direct costs from NIH. The author's final manuscript is defined as
the final version accepted for journal publication, and includes all
modifications from the publishing peer review process.<br>
<br>
NIH is requesting that authors submit manuscripts resulting from 1) currently
funded NIH research projects or 2) previously supported NIH research projects
if they are accepted for publication on or after May 2, 2005. The NIH Public
Access Policy applies to all research grant and career development award
mechanisms, cooperative agreements, contracts, Institutional and Individual
Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural
research studies. The Policy applies to peer-reviewed, original research
publications that have been supported in whole or in part with direct costs
from NIH, but it does not apply to book chapters, editorials, reviews, or
conference proceedings. Publications resulting from non-NIH-supported research
projects should not be submitted. <br>
<br>
For more information about the Policy or the submission process, please visit
the NIH Public Access Policy Web site at <a href="http://publicaccess.nih.gov/">http://publicaccess.nih.gov</a>/
and view the Policy or other Resources and Tools, including the <a
href="http://publicaccess.nih.gov/publicaccess_manual.htm">Authors' Manual</a>. <br>
<br>
<b>Standards for Privacy of Individually Identifiable Health Information:</b> <br>
The Department of Health and Human Services (HHS) issued final modification to
the "Standards for Privacy of Individually Identifiable Health Information",
the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal
regulation under the Health Insurance Portability and Accountability Act
(HIPAA) of 1996 that governs the protection of individually identifiable health
information, and is administered and enforced by the HHS Office for Civil
Rights (OCR). <br>
<br>
Decisions about applicability and implementation of the Privacy Rule reside
with the researcher and his/her institution. The OCR website (<a href="https://www.hhs.gov/ocr/">http://www.hhs.gov/ocr/</a>) provides
information on the Privacy Rule, including a complete Regulation Text and a set
of decision tools on "Am I a covered entity?" Information on the
impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and
research contracts can be found at <a
href="//grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html">http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html</a>. <br>
<br>
<b>Healthy People 2010:</b> <br>
The Public Health Service (PHS) is committed to achieving the health promotion
and disease prevention objectives of "Healthy People 2010," a PHS-led
national activity for setting priority areas. This FOA is related to one or
more of the priority areas. Potential applicants may obtain a copy of
"Healthy People 2010" at <a href="https://www.health.gov/healthypeople">http://www.health.gov/healthypeople</a>. <br>
<br>
<b>Authority and Regulations:</b> <br>
This program is described in the <span class=styleregulartextarialitalicblack>Catalog
of Federal Domestic Assistance</span> at <a href="https://www.cfda.gov/">http://www.cfda.gov/</a> and is not subject to the intergovernmental review requirements of Executive
Order 12372 or Health Systems Agency review. 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 Parts 74 and 92. All awards are subject to the terms and conditions,
cost principles, and other considerations described in the <em><a
href="//grants.nih.gov/grants/policy/nihgps_2003/index.htm">NIH Grants
Policy Statement</a></em>. <br>
<br>
The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and discourage the use of all tobacco products. In addition, Public
Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain
facilities (or in some cases, any portion of a facility) in which regular or
routine education, library, day care, health care, or early childhood
development services are provided to children. This is consistent with the PHS
mission to protect and advance the physical and mental health of the American
people. <br>
<br>
<b>Loan Repayment Programs:</b> <br>
NIH encourages applications for educational loan repayment from qualified
health professionals who have made a commitment to pursue a research career
involving clinical, pediatric, contraception, infertility, and health
disparities related areas. The LRP is an important component of NIH's efforts
to recruit and retain the next generation of researchers by providing the means
for developing a research career unfettered by the burden of student loan debt.
Note that an NIH grant is not required for eligibility and concurrent career
award and LRP applications are encouraged. The periods of career award and LRP
award may overlap providing the LRP recipient with the required commitment of
time and effort, as LRP awardees must commit at least 50% of their time (at
least 20 hours per week based on a 40 hour week) for two years to the research.
For further information, please see: <a href="http://www.lrp.nih.gov">http://www.lrp.nih.gov</a>. </p>
<P><HR><P>
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