NOTICE: Pre-applications submitted in response to this
Funding Opportunity Announcement (FOA) for Federal assistance must be submitted
electronically through Grants.gov (http://www.grants.gov) using
the SF424 Research and Related (R&R) forms and the SF424 (R&R)
Application Guide.

APPLICATIONS MAY NOT
BE SUBMITTED IN PAPER FORMAT.

This FOA must be read
in conjunction with the application guidelines included with this announcement
in Grants.gov/Apply
for Grants (hereafter called Grants.gov/Apply).

A registration process
is necessary before submission and applicants are highly encouraged to start
the process at least four (4) weeks prior to the grant submission date. See Section IV.

Purpose.The NIH Director’s
New Innovator Awards Program (http://nihroadmap.nih.gov/newinnovator/)
was created in 2007 to support a small number of new investigators of
exceptional creativity who propose bold and highly innovative new research
approaches that have the potential to produce a major impact on broad,
important problems in biomedical and behavioral research. The research proposed
need not be in a conventional biomedical or behavioral discipline but must be
relevant to the mission of NIH. The New Innovator Awards complement ongoing
efforts by NIH and its Institutes and Centers to fund new investigators through
R01 grants, which continue to be the major source of NIH support for new
investigators. The purpose of this FOA is to solicit pre-applications for the
NIH Director’s New Innovator Award. Pre-applications are a necessary first step in applying
for a 2009 New Innovator Award. Pre-applications will be evaluated by a group
of external reviewers. Those investigators whose submissions are judged to be
the most outstanding will be notified of the opportunity to submit full (DP2)
applications under RFA-RM-09-003.
All awards will be made under RFA-RM-09-003.
No awards will be made under this announcement. For additional information,
consult the FAQs at http://nihroadmap.nih.gov/newinnovator/faq.aspx.

Mechanism
of Support. This FOA utilizes the X02 grant mechanism for submission of
pre-applications.

Funds Available and Anticipated Number of Awards.No
awards will be made in response to this FOA. Through the associated FOA (RFA-RM-09-003),
NIH expects to commit approximately $55.7 million for the five-year
period. It is anticipated that up to 24 awards will be made in 2009.

Budget and Project Period.No awards will be made under this
announcement. Awards through RFA-RM-09-003 will be for up to $300,000 in direct costs each year for five years, plus
applicable Facilities and Administrative costs, which will be determined
at the time of award.

Eligible
Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources
necessary to carry out the proposed research are invited to work with
their institution/organization to develop a pre-application for support. Women and individuals from underrepresented racial and ethnic groups as well
as individuals with disabilities are always encouraged to apply for NIH
support. Investigators (PD/PIs)
must hold an independent research position at a domestic (U.S.)
institution as of September 19, 2009 and must have received their most
recent doctoral degree (e.g., Ph.D., M.D., D.D.S., D.V.M., PharmD, or
equivalent) or completed their medical internship and residency no earlier
than 1999 and no later than the due date for pre-applications. For the
purpose of this FOA, “independent research position” means a position that
automatically confers eligibility by the researcher’s institutional policy
for an investigator to apply for R01 grants, with an appropriate
commitment of facilities to be used for the conduct of the proposed
research. Investigators still in training or mentored status (postdoctoral
fellows) are not eligible to apply unless they have a written commitment
of an independent faculty position as of September 19, 2009; submission of
the pre-application from that institution serves as the written commitment
of an independent faculty position.

PDs/PIs must meet the
definition of “new investigator.” For the purpose of this FOA, “new
investigators” are defined as those PDs/PIs who have never been awarded an R01
or equivalent NIH grant (e.g., R23, R29, R33, R37, DP1, DP2, U01, P01 or center
grant) or been the leader of a P01 or center grant peer-reviewed project.
Individuals who are PDs/PIs on multi-PI R01 or equivalent NIH grants are not
eligible to apply for the New Innovator Award. Current or past recipients of K
awards are eligible except for the following: K99/R00 or other Independent
Scientist and other non-mentored career awards (K02, K04, K05, K24, and K26).
Investigators may submit or have an R01 (or equivalent) grant application
pending concurrently with their New Innovator Award pre-application or
application. However, if that pending grant is awarded in Fiscal Year 2009 with
a start date of September 30 or earlier, the applicant is no longer eligible to
receive the New Innovator Award. Awardees are required to commit at least 25%
of their research effort each year to activities supported by the New Innovator
Award. Applicants who were not selected for an award in prior years may submit
pre-applications this year if the applicant still meets all the eligibility
criteria. There are no citizenship or residency requirements.

Number
of PDs/PIs.Only one PD/PI may be
designated on the pre-application.

Number
of Pre-Applications. An individual may
submit no more than one pre-application. There
is no limit to the number of pre-applications that institutions may
submit.

Resubmissions. Resubmissions are not
allowed. All
pre-applications must be submitted as “new,” regardless of any previous
submissions to the New Innovator Award Program.

The NIH Director’s New Innovator Award is designed to
support new investigators of exceptional creativity who propose bold and highly
innovative new research approaches that have the potential to produce a major
impact on broad, important problems in biomedical and behavioral research. 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 research proposed for a New Innovator Award may be in
any scientific area relevant to the mission of NIH (biological, behavioral,
clinical, social, physical, chemical, computational, engineering, and
mathematical sciences) but need not be in a conventional biomedical or
behavioral discipline. The focus is on innovation and potential impact.

This FOA announces the 2009 New Innovator Award competition
for fiscal year 2009 and solicits pre-applications.

This
announcement utilizes the X02 mechanism for submission of pre-applications.
Pre-applications are a necessary first step in applying for a 2009 New
Innovator Award. Pre-applications will be evaluated by a group of external
reviewers. Those investigators whose submissions are judged to be the
most outstanding will be notified of the opportunity to submit full (DP2)
applications under RFA-RM-09-003. The Project Director/Principal
Investigator (PD/PI) will be solely responsible for planning, directing, and
executing the proposed project.

2.
Funds Available

Not applicable. No awards will be made under this FOA. All
awards will be made under RFA-RM-09-003.

Any individual
with the skills, knowledge, and resources necessary to carry out the proposed
research as the PD/PI is invited to work with his/her organization to develop a
pre-application. Women and individuals from underrepresented racial and ethnic
groups as well as individuals with disabilities are always encouraged to apply
for NIH support. Only one PD/PI (i.e., no multiple PDs/PIs) may be designated
on the pre-application. NIH intramural
investigators are not eligible for support under this program.

PDs/PIs must hold
an independent research position at a domestic (U.S.) institution as of
September 19, 2009 and must have received their most recent doctoral degree
(e.g., Ph.D., M.D., D.D.S., D.V.M., PharmD, or equivalent) or completed their
medical internship and residency no earlier than 1999 and no later than the due
date for pre-applications. Any request for an exception to the eligibility
requirement of time from last doctoral degree must be based upon additional
medical training (e.g., clinical fellowship) or unusual circumstances. For
requests based on clinical fellowship training, only the time spent in clinical
training, not in research training, will be considered. Requests must be
specifically justified in the Biographical Sketch in the pre-application and
will be considered on a case-by-case basis. Investigators who do not meet these
eligibility requirements and whose pre-applications lack an explicit and
justified request for an exception in the Biographical Sketch will be
considered ineligible.

For the purpose of
this FOA, “independent research position” means a position that automatically
confers eligibility, by the researcher’s institutional policy, for an
investigator to apply for R01 grants, with an appropriate commitment of
facilities to be used for the conduct of the proposed research. Investigators
still in training or mentored status (postdoctoral fellows) are not eligible to
apply unless they have a written commitment of an independent faculty position
as of September 19, 2009; submission of the pre-application from that
institution will serve as the written commitment of an independent faculty
position.

PDs/PIs must meet
the definition of “new investigator.” For the purpose of this FOA, “new
investigators” are defined as those applicants who have never been the PI on an
R01 or equivalent grant (e.g., R23, R29, R33, R37, DP1, DP2, U01, P01 or center
grant) or leader of a P01 or center grant peer-reviewed project that was
reviewed in the investigator’s name. Multiple PIs have the same leadership
status on grants as individual PIs; therefore, researchers who have served as
one of multiple PIs on any ineligible grant are no longer considered new
investigators and are not eligible to apply for a New Innovator Award. Current
or past recipients of K awards are eligible except for the following: K99/R00
or other Independent Scientist and other non-mentored career awards (K02, K04,
K05, K24, and K26). Investigators may submit or have an R01 (or equivalent)
grant application pending concurrently with their New Innovator Award
pre-application. However, if that pending grant is awarded in Fiscal Year 2009
with a start date of September 30 or earlier, the applicant is no longer
eligible to receive the New Innovator Award. Awardees are required to commit at
least 25% of their research effort each year to activities supported by the New
Innovator Award. An applicant
who was not selected for an award in prior years may submit a pre-application
this year if the applicant still meets all the eligibility criteria; however,
all pre-applications must be submitted as “new” regardless of any previous
submissions to the New Innovator Award program. There are no citizenship or
residency requirements.

The proposed
research need not be in a conventional biomedical or behavioral discipline but
must be relevant to the mission of NIH. This initiative is to support new
investigators proposing new and innovative research with potential for
exceptionally high impact on biomedical problems.

An individual may not submit more than one pre-application.
There is no limit to the number of pre-applications an institution may submit.
All pre-applications will be considered “new,” regardless of any previous
submissions to the New Innovator Award Program

Section IV. Application and Submission Information

To
download a SF424 (R&R) Application Package and SF424 (R&R) Application
Guide for completing the SF424 (R&R) forms for this FOA, use the “Apply for
Grant Electronically” button in this FOA or link to http://www.grants.gov/Apply/ and follow
the directions provided on that Web site. See the detailed instructions below
regarding choosing a pre-application package (Section 1- Request Application
Information).

A one-time registration is required for institutions/organizations at both:

The individual designated as PD/PI
on the pre-application must be registered also in the NIH eRA Commons.

The PD/PI must
hold a PD/PI account in the Commons. Applicants should not share a Commons account for both an Authorized Organization
Representative/Signing Official (AOR/SO) role and a PD/PI role; however, if they have both a
PD/PI role and an NIH Internet Assisted Review (IAR) role, both roles should
exist under one Commons account.

This registration/affiliation must
be done by the AOR/SO or his/her designee who is already registered in the Commons.

Both the PD/PI and
AOR/SO need separate accounts in the NIH eRA Commons since both are authorized
to view the application image.

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.

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 Grants.gov and the Commons. The NIH will accept
electronic applications only from organizations that have completed all
necessary registrations.

1. Request Application Information

Individuals submitting
a pre-application must download the SF424 (R&R) application forms and the
SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply. After clicking “Apply for Grant
Electronically,” individuals will be presented with a list of ten
pre-application packages corresponding to ten scientific areas, as described in
the Special Instructions in Section 2 below. The
selection of scientific area by investigators is solely to aid in selection of
the most appropriate group of peer reviewers. The pre-application requirements
and instructions below are identical for all ten packages. All ten scientific areas are considered as a single competition, are
reviewed in the same time period, and compete for a single source of funds.

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 useable for more than one FOA.

Prepare all
pre-applications using the SF424 (R&R) application forms and in accordance
with the SF424 (R&R) Application Guide for this
FOA through Grants.gov/Apply.

The SF424 (R&R)
Application Guide is critical to submitting a complete and accurate
pre-application to NIH. Some fields within the SF424 (R&R) application
components, although not marked as mandatory, are required by NIH (e.g., the
“Credential” log-in field of the “Research & Related Senior/Key Person
Profile” component must contain the PD/PI’s assigned eRA Commons User ID).
Agency-specific instructions for such fields are clearly identified in the
Application Guide. For additional information, see “Frequently Asked Questions
– Application Guide, Electronic
Submission of Grant Applications.”

The SF424 (R&R)
pre-application has several components. Some components are required, others
are optional. The forms package associated with this FOA in Grants.gov/APPLYincludes all applicable components, required and optional. A completed
pre-application in response to this FOA includes the data in the following
components:

Optional Components: PHS 398 Cover Letter File
Note: Cover letters should be submitted only when submitting a
Changed/Corrected Pre-application after the submission date and should include
an explanation for the late submission.

SPECIAL
INSTRUCTIONS

Pre-applications with multiple PDs/PIs are not allowed.

ADDITIONAL
PRE-APPLICATION INSTRUCTIONS

The following instructionsare
specific to the New Innovator Award X02 pre-applications and are exceptions to
the general SF424 instructions. Pre-applications that do not conform to the
specific instructions detailed below will not be reviewed. There are significant changes to
the instructions from previous years, so please review all instructions
carefully.

All of the following must be submitted for the
pre-application to be considered complete:

I. Area
of Science Designation: Individuals must designate one of the following ten areas of science for their pre-application:

The
areas of science are used by NIH staff to assist in assigning pre-applications
to the most appropriate reviewers. To designate a science area, the
investigator must do the following:

1. Download and submit the pre-application with the Grants.gov
application package for the chosen science area. There are 10 separate pre-application packages
(Competition IDs) in Grants.gov for this Funding Opportunity Announcement (FOA), one for each of the above areas of science.
Individuals must download and submit the pre-application package for their
chosen area of science. The pre-application requirements and instructions are
identical for all ten packages. The only difference between
the packages istheindicated category of scientific research. The selection of
scientific area by the PD/PI is solely to aid in selection of the most
appropriate group of peer reviewers and does not in itself affect the PD’s/PI’s
funding potential. All ten scientific areas are
considered as a single competition and are reviewed by the same process, in the
same time period, and compete for a single source of funds. PDs/PIs may
download and submit only one of the ten pre-application packages.

2. Include the area of science and
the project title at the top of the abstract page. The area of science and project title will not be included
in the 300 word limit.

3. Verify that the pre-application has been submitted to the
appropriate science area.
The PD/PI must check the Competition ID field on the
first page of their pre-application (the transmittal sheet) in the Commons. If
the pre-application has been submitted to the wrong science area, the PD/PI
must notify program staff immediately by e-mail to newinnovator@nih.gov. Failure to correct the science area of the pre-application may adversely affect
the pre-application’s review as it may not be reviewed by the most appropriate
group of external reviewers.

II. Abstract: An abstract of no more than 300 words and not to exceed
one page, describing the goals of the project. Include the Project Title and
Area of Science at the top of the abstract page; these do not count toward the
300 word limit. The abstract must contain text only –
no figures, animations, or web links to provide further information. The Abstract is uploaded as an attachment for item 6,
Project Summary/Abstract, on the Other Project Information component of the
pre-application.

III. Public
Health Relevance Statement: A brief statement written in plain language about how the
proposed research can positively impact public health. This statement is uploaded for Item 7, Project Narrative,
on the Other Project Information component of the pre-application.

IV. Essay: An essay of no more than 10 pages that addresses (1) the
significance and potential impact of the project, (2) what makes the approaches
exceptionally innovative and how the PD/PI will address risks and challenges,
and (3) the applicant’s qualifications for this
award. A scientific plan should be provided, written with a level of detail
appropriate for reviewers who are broadly knowledgeable but who may not be
directly involved in the proposed area of research. To focus the essay on the
goals of the New Innovator Award program and the
review criteria for pre-applications, presentation of the proposed research as
a series of specific aims is discouraged. The essay should include the
following sections within the 10-page limit, in the following order, with the headings shown:

Project description: Describe the scientific problem that you propose to
address, its importance, and how solving this problem would have a major impact
on a broad area of biomedical/behavioral science. Why is the planned research uniquely suited to the New Innovator Award program, rather
than a traditional grant mechanism? How is this project distinct from other
research that may be supported in your laboratory?

Innovativeness: State clearly and concisely what makes your project unusually innovative. If the approaches entail a high degree
of risk, what will you do if these approaches are not successful?

Investigator
qualifications:
Provide evidence to support your claim of innovativeness and creativity in your
research. For example, which personal qualities and
experiences demonstrate your inclination to challenge paradigms and take
intellectual risks, develop unique collaborations, integrate diverse sources of
information, or develop novel approaches when new challenges or opportunities arise?

Preliminary data are
allowed but not required. Bibliographic citations (references), figures, and
illustrations may be included, but must fit within the 10-page limit. Do not
include links to websites to provide further information. No animations (movies) are allowed in any documents. The Essay is uploaded in the Research Design and Methods
attachment of the Research Plan Component. Omit the Specific Aims, Background
and Significance, and Preliminary Studies Sections.

V. Biographical
sketch: A two-page biographical sketch for the PD/PI only. (Use
the format for biographical sketches shown in Section 4.5.2 of the Application
Guide, omitting Section C, Research Support.) Biographical sketches for other key personnel should not
be submitted and will not be accepted. A request for
an exception to the eligibility requirement of time from last doctoral degree
must be specifically justified in this section of the pre-application and must
be based upon additional medical training, such as a clinical fellowship, or unusual circumstances, such as time away from
research for care of young children or for military service. Requests will be
considered on a case-by-case basis when the pre-application is received.
Pre-applications from investigators who exceed the
time from last doctoral degree or completion of medical internship/residency
and who fail to provide a well-justified request for an exception to this
eligibility requirement will not be reviewed. The Biographical Sketch is uploaded on the Research & Related Senior/Key Person Component form.

VI. List
of Current and Pending Research Support: A list of current and pending research support from all
sources, including current year direct costs and percent effort devoted to each
project. (Use the format shown in the Application
Guide, Part III, Section 3.1.8). The PD/PI must include an Effort Commitment
statement, described below. Applicants must also include in this section a
brief statement of the facilities to be used for the conduct of the research. This document is uploaded on the
Research & Related Senior/Key Person Component form.

VII. Effort
Commitment:
Awardees are required to commit at least 25% of their research effort to the
project supported by the New Innovator Award. In the list of current and pending support, the PD/PI must include a statement
that, if chosen to receive an award under RFA-RM-09-003, the PD/PI will commit
a minimum of 25% of his/her research effort to the project supported by the New
Innovator Award.

Special requirements
for completing the SF424 (R&R) pre-application
are specified below. In addition:

For Budget request, enter zero for all categories. No awards will be made in
response to the pre-application FOA.

No other documentation,
such as letters of collaboration or biographical
sketches of other personnel will be accepted. Information about personnel other
than the PD/PI is not required, but may be included within the 10-page essay.

All instructions outlined in the SF 424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_Ver2.pdf) are to be followed, incorporating “Just-in-Time” information concepts, with the following
exceptions, which are specific requirements for New Innovator Award
pre-applications. Pre-applications that do not conform to the specific
instructions detailed below will not be reviewed.

1. SF424 (R&R) COVER COMPONENT

Item Number and Title

Instructions

1. Type of Submission

Must be “Pre-Application”

8. Type of Application

Must be “New”

13. Proposed Project

Enter start date: 09/30/2009; Enter end date: 08/31/2014

Estimated Project Funding

Enter $0

2. RESEARCH &
RELATED PROJECT/PERFORMANCE SITE LOCATIONS

Complete as appropriate

3. RESEARCH &
RELATED OTHER PROJECT INFORMATION COMPONENT:

Item Number and Title

Instructions

1. Are Human Subjects Involved?

Check “No” – Detailed plans regarding protection of human subjects,
inclusion of women and minorities, targeted/planned enrollment, and inclusion
of children are not required and should not be submitted with this
pre-application. This information will be required from only those
individuals who submit full applications in response to RFA-RM-09-003.

2. Are Vertebrate Animals Used?

Check “No” – Detailed information regarding the use of vertebrate
animals is not required at the time of submission. This information will be
required only from those individuals who submit full applications in response
to RFA-RM-09-003.

6. Project Summary/Abstract

Attach Abstract (maximum of 300 words and not to exceed one page).
Include Project Title and Science Area at top of page. PDF format; text only
– no figures, animations, or web links.

7. Project Narrative

Attach Public Health Relevance Statement (2-3 sentences), explaining
the relevance of the research to public health); PDF format

8. Bibliography & References Cited

Do not use. If you choose to include figures or reference citations,
they must be included in the Essay, subject to the 10-page limit.

9. Facilities & Other Resources

Do not use.

10. Equipment

Do not use.

11. Other Attachments

Do not use.

Note: Pre-applications found not to
comply with the page limit requirements or that contain attachments other than
those specified will be rejected during the agency validation process.

4. SF424 (R&R)
SENIOR/KEY PERSON PROFILE COMPONENT:

Complete items only for
Project Director/Principal Investigator. Do not
submit profiles for other senior/key personnel.

Item Title

Instructions

Profile- PD/PI – Attach Biographical Sketch

Attach biographical sketch here (two-page maximum; 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). Any request for an
exception to the eligibility requirement of time from last doctoral degree or
medical internship/residency must be specifically justified in this section
of the application, as described in Section IV.2.

Profile- PD/PI – Attach Current & Pending Support

Attach a list of Current and Pending Support here (no page
limit; PDF format). Use the format shown in Part III, Section 3.1.8 of the
Application Guide. Be sure to include a statement affirming that you will
devote at least 25% of research effort to New Innovator Award project. Also,
include in this section a brief statement of the facilities to be used for
the conduct of the research.

Profile – Senior Key Person 1

Do not use. Submit information only
for PD/PI. Information on collaborators may be included in the essay.

Note: Pre-applications found not to comply with the page limit
requirements will not be reviewed.

No other documentation,
such as letters of reference or collaboration or
other biographical sketches will be accepted. Information about personnel other
than the PD/PI is not required but may be included within the 10-page essay.

4. PHS398 COVER PAGE
SUPPLEMENT

Item Title

Instructions

2. Human Subjects

Omit.

4. Human Embryonic Stem Cells

Omit.

5. PHS398 Research Plan
Component Sections

Item Number and Title

Instructions

1. Introduction to Application (for Resubmission or Revision only)

Omit

2. Specific Aims

Omit

3. Background and Significance

Omit

4. Preliminary Studies/Progress Report

Omit

5. Research Design and Methods

Attach 10- page essay (PDF format). Include the area of science
(e.g., (01 – Behavioral and Social Sciences) and project title on the first
page of essay. Literature references are not required but if included must
fit within the 10-page limit. Figures and illustrations may be included but
must also fit within the 10-page limit. Do not include links to websites for
further information. Do not include animations.

6. PHS 398 Cover Letter File (Optional):

Cover letters should be
included only when submitting late pre-applications or Changed/Corrected
pre-applications after the submission deadline. Do not submit cover letters for
initial submissions or for changed/corrected
pre-applications submitted before the submission deadline. The cover letter
should contain only the following information:

To submit a
pre-application in response to this FOA, PDs/PIs should access this FOA via http://www.grants.gov/applicants/apply_for_grants.jsp
and follow Steps 1-4. Note: Pre-applications must only be submitted
electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED.

3.C.
Application Processing

Pre-applications may be submitted on or after the
opening date and must be successfully received by Grants.gov no later
than 5:00
p.m. local time (of the
PDs/Pis institution/organization) on the pre-application due date. (See Section IV.3.A. for all dates.) If an pre-application is not submitted by the due date
and time, the pre-application may be delayed in the review process or not
reviewed.

Once a pre-application package has been
successfully submitted through Grants.gov, any errors have been addressed, and
the assembled pre-application has been created in the eRA Commons, the PD/PI and
the Authorized Organization Representative/Signing Official (AOR/SO) have two
weekdays (Monday – Friday, excluding Federal holidays) to view the
pre-application image to determine if any further action is necessary.

If everything is
acceptable, no further action is necessary. The
pre-application will automatically move forward to the Division of Receipt
and Referral in the Center for Scientific Review for processing after two weekdays,
excluding Federal holidays.

Prior to the submission
deadline, the AOR/SO can “Reject” the assembled pre-application and submit
a changed/corrected pre-application within the two-day viewing window.
This option should be used if it is determined that some part of the
pre-application was lost or did not transfer correctly during the
submission process, the AOR/SO will have the option to “Reject” the
pre-application and submit a Changed/Corrected pre-application. In these cases, please contact the eRA
Help Desk to ensure that the issues are addressed and corrected. Once
rejected, PDs/PIs should follow the instructions for correcting errors in
Section 2.12, including the requirement for cover letters on late
applications. The “Reject” feature should
also be used if you determine that warnings are applicable to your
pre-application and need to be addressed now. Remember, warnings do not
stop further pre-application processing. If a pre-application submission
results in warnings (but no errors), it will automatically move forward
after two weekdays if no action is taken. Some warnings may need to be addressed later in the process.

If
the two-day window falls after the submission deadline, the AOR/SO will have
the option to “Reject” the pre-application if, due to an eRA Commons or Grants.gov system issue, the pre-application does not correctly reflect the submitted
pre-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 eRA Commons Helpdesk 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.

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 pre-application still can be submitted, but it will be
subject to the NIH late
policy guidelines and may not be accepted. The reason for this delay should
be explained in the cover letter attachment.

Both
the AOR/SO and PD/PI will receive e-mail notifications when the pre-application
is rejected or the pre-application automatically moves forward in the process
after two weekdays.

Upon receipt, pre-applications will be evaluated for
completeness by the Center for Scientific Review, NIH. Incomplete pre-applications
will not be reviewed.

There
will be an acknowledgement of receipt of pre-applications from Grants.gov and
the Commons. The submitting AOR/SO
receives the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons acknowledgments. Information related to the assignment of a pre-application to a
Scientific Review Group is also in the Commons.

Note: Since email can be
unreliable, it is the responsibility of the applicant to check periodically on
their pre-application status in the Commons.

The NIH will not
accept any pre-application in response to this FOA that is essentially the same
as one currently pending initial review, unless the applicant
withdraws the pending application. When a previously unfunded application,
originally submitted as an investigator-initiated application, is to be
submitted in response to a funding opportunity, it is to be prepared as a NEW
application. That is, the application for the FOA
must not include an “Introduction” describing the changes and improvements
made, and the text must not be marked to indicate the changes from the previous
unfunded version of the application.

The
PI/PD 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, Electronic
Submission of Grant Applications.”

Appendix
Materials

Appendices are not allowed and will not
be accepted. Pre-applications that contain
attachments other than those specified may be rejected during the agency
validation process.

Resource
Sharing Plan(s)

The following resource sharing policies
do not apply to this FOA:

Data Sharing Plan. Not Applicable

Sharing Model Organisms. Not Applicable

Genome Wide Association Studies (GWAS).
Not Applicable

Section V. Application Review Information

1.
Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).

Only
the review criteria described below will be considered in the review process.

2. Review and Selection Process

Pre-applications that are complete and responsive will be evaluated by a group of
external reviewers, which will include eminent scientists with expertise in the
ten science areas designated in the “Additional Pre-Application Instructions”
section above. Those investigators whose submissions
are judged to be the most outstanding will be notified of the opportunity to
submit full (DP2) applications under RFA-RM-09-003. Given the nature of the review, no summary statement or other written critique will
be provided to the submitting individual.

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 PD’s/PI’s potential for creative and innovative
research as a “new investigator.” Specifically, reviewers will evaluate:

The scientific problem to be addressed: The importance of the scientific
problem and the likelihood that, if successful,
the project will have a major impact on a broad area of biomedical or
behavioral research.

Innovativeness of the research proposed: Evidence that the proposed
scientific problem and/or the 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.

Investigator qualifications: Evidence of the investigator’s creativity and potential for innovation and the
commitment of the investigator to devote 25% or more of his/her research
effort on the New Innovator Award project.

2.A.
Additional Review Criteria

None.

2.B. Additional Review
Considerations

For this FOA,
no specific budget information is to be submitted either with the application
or just-in-time.

2.C. Sharing Research Data

The
following resource sharing policies do not apply to this FOA:

Data Sharing Plan. Not Applicable

Sharing Model Organisms. Not
Applicable

Genome Wide Association Studies
(GWAS). Not Applicable

3.
Anticipated Announcement and Award Dates

Those
investigators whose submissions are judged to be the most outstanding will be
notified in April 2009 of the opportunity to submit full (DP2) applications
under RFA-RM-09-003. Awards will be made under RFA-RM-09-003. Awards under
RFA-RM-09-003 will be announced in September 2009 and will begin September 30,
2009.

Section
VI. Award Administration Information

1.
Award Notices

Not Applicable

2. Administrative and National Policy Requirements

Not Applicable

3.
Reporting

Not Applicable

Section
VII. Agency Contacts

Many
questions are addressed in the FAQs on the New Innovator web site at http://nihroadmap.nih.gov/newinnovator/. We encourage your inquiries concerning
this funding opportunity and welcome the opportunity to answer questions from
potential applicants. Inquiries may fall into three areas: scientific/research
(program), peer review, and financial or grants
management issues:

NOTE: Information responsive to the following federal citations should not be submitted with the X02 New Innovator
Award pre-application. Applicants who are invited to submit DP2 applications
will be asked to submit the following information as part of the DP2
application.

Human Subjects
Protection: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 (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety
Monitoring Plan: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,” NIH Guide
for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Access to Research Data through the Freedom of Information Act: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 http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
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.

Inclusion of
Women And Minorities in Clinical Research: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” (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
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.

Inclusion of Children as Participants in Clinical Research: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. 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 (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants: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 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):Criteria for Federal funding of research on hESCs can
be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the NIH Human Embryonic
Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). 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.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy, investigators
funded by the NIH must submit or have submitted for them to the National
Library of Medicine’s PubMed Central (see http://www.pubmedcentral.nih.gov/), an electronic version of their final, peer-reviewed
manuscripts upon acceptance for publication, to be made publicly available no
later than 12 months after the official date of publication. The
NIH Public Access Policy is available at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html).For more
information, see the Public Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable Health Information: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).

Decisions about applicability and implementation of
the Privacy Rule reside with the researcher and his/her institution. The OCR
website (http://www.hhs.gov/ocr/)
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 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs
in NIH Grant Applications or Appendices:
All applications and proposals
for NIH funding must be self-contained within specified page limitations. For
publications listed in the appendix and/or Progress report, Internet addresses
(URLs) or PubMed Central (PMC) submission identification numbers must be used
for publicly accessible on-line journal articles. Publicly accessible
on-line journal articles or PMC articles/manuscripts accepted for publication
that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference
in either the Bibliography & References Cited section, the Progress Report
Publication List section, or the Biographical Sketch section of the NIH grant
application. A URL or PMC submission identification number citation may be
repeated in each of these sections as appropriate. There is no limit to the
number of URLs or PMC submission identification numbers that can be cited.

Healthy People 2010: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 http://www.health.gov/healthypeople.

Authority and Regulations:This
program is described in the Catalog of Federal
Domestic Assistance at http://www.cfda.gov/ and is not
subject to the intergovernmental review requirements of Executive Order 12372.
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 NIH Grants
Policy Statement.

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.

Loan Repayment Programs: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: http://www.lrp.nih.gov/.