Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)

Components of Participating Organizations
This FOA is developed as an NIH Roadmap initiative (http://grants.nih.gov/grants/new_investigators/innovator_award/); all NIH Institutes and Centers are participating. This FOA is being administered by the National Institute of General Medical Sciences (NIGMS) on behalf of the NIH.

Title: 2008 NIH Director’s New Innovator Award Program (DP2)

Announcement Type
This is a reissue of RFA-RM-07-009, which was previously released March 9, 2007.

Update: The following update relating to this announcement has been issued:

NOTICE: 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 weeks prior to the grant submission date. See Section IV.

Request For Applications (RFA) Number: RFA-RM-08-014

Catalog of Federal Domestic Assistance Number(s)
93.310

Key Dates
Release/Posted Date: November 9, 2007
Opening Date: March 3, 2008 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): Not applicable.
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).
Application Submission/Receipt Date: March 31, 2008
Peer Review Date(s): May-June, 2008
Advisory Council to the Director Review Date: August 2008
Earliest Anticipated Start Date: September 30, 2008
Additional Information To Be Available Date (Activation Date): October 24, 2007 - Frequently Asked Questions (FAQs) at http://grants.nih.gov/grants/new_investigators/innovator_award/faq_2008.htm
Expiration Date: April 1, 2008

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Applicant PD/PIs must hold an independent research position at a domestic (U.S.) institution as of September 19, 2008 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 no earlier than 1998 and no later than the receipt date for applications. For the purpose of this FOA, independent research position means a position that automatically confers eligibility, by the applicant’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, 2008 that is certified by submission of the application from that institution.

Applicants must meet the definition of new investigator. For the purpose of this FOA, new investigators are defined as those applicants who have never been PI on an R01 or equivalent NIH 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. 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). Applicants may submit or have an R01 (or equivalent) grant application pending concurrently with their New Innovator Award application. However, if that pending grant is awarded in Fiscal Year 2008 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.

There are no citizenship or residency requirements.

Applications proposing multiple PIs are not allowed.

Number of Applications. 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. All applications for the 2008 New Innovator Award will be considered as new applications, regardless of any previous applications to the New Innovator Award Program.

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission, Review, and Anticipated Start Dates
1. Letter of Intent
B. Submitting an Application Electronically to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
A. Cooperative Agreement Terms and Conditions of Award
3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

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.

Background

The NIH's success depends on the creativity of investigator-initiated research, much of it supported by the R01 grant mechanism. The NIH Director’s Pioneer Award (http://nihroadmap.nih.gov/pioneer/) was created several years ago 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.

The NIH Director’s New Innovator Award (http://grants.nih.gov/grants/new_investigators/innovator_award/) 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 sources of NIH support for new investigators. Thirty New Innovator Awards were made in 2007. For information on these New Innovator Awardees, see the New Innovator Award web site at http://grants.nih.gov/grants/new_investigators/innovator_award/.

This FOA announces the second NIH Director’s New Innovator Award competition for up to 24 awards of up to $1.5 million for a five-year period (an average annual budget of up to $300,000 direct costs) plus applicable Facilities and Administrative costs. Awards will be made in Fiscal Year 2008.

Analysis of the 2007 cohort of applications indicated that many of the proposed projects were innovative and addressed significant problems in biomedical or behavioral sciences. However, a large number of the projects did not rise to the level of innovation and potential impact expected for this new grant mechanism. Specifically, the New Innovator Award program is meant to support bold and highly innovative new research approaches to important questions of broad biomedical or behavioral significance. The potential impact of the proposed research, if successful, is a major review criterion. Based on the experience from the first New Innovator Award competition, this FOA contains several changes intended to emphasize even more strongly this program’s requirement for substantial innovation and the potential for major impact on a significant problem in biomedical or behavioral research. (See FAQs on New Innovator web site (http://grants.nih.gov/grants/new_investigators/innovator_award/faq_2008.htm) for summary of changes in this FOA.)

This FOA uses Just-in-Time information concepts. For this FOA only, information regarding protection of human subjects, inclusion of women, minorities and children in research, animal care and use, biohazard protection, and sharing of model organisms should not be submitted with this application. The required information will be requested just-in-time if an award is being considered.

Section II. Award Information

1. Mechanism of Support

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. If this FOA is reissued, competing renewal (formerly competing continuation ) applications will not be accepted. All applications will be considered new applications, regardless of any previous applications to the New Innovator Award Program.

2. Funds Available

This is a Roadmap initiative. The NIH Common Fund intends to commit up to $55 million dollars in FY2008 to fund up to 24 grants for the five-year period, contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.

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.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

For this FOA, Facilities and Administrative (F&A) costs requested by consortium participants must be included in the total direct costs requested. The F&A costs for the primary grantee institution will be added at the time of award, and will be based on the grantee institution s current negotiated rate.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit an application(s) if your institution/organization is a domestic institution that has any of the following characteristics:

Non-domestic (non-U.S.) entities (Foreign Organizations) are not eligible to apply.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI), and who meets the eligibility criteria below, is invited to work with his/her organization to develop an application for support. Women and members of groups underrepresented in biomedical or behavioral research are especially encouraged to apply.

Applicant PD/PIs must hold an independent research position at a domestic (U.S.) institution as of September 19, 2008 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 no earlier than 1998 and no later than the receipt date for 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 application and will be considered on a case-by-case basis. Applicants who do not meet these eligibility requirements and whose 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 applicant’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, 2008 that is certified by submission of the application from that institution.

Applicants must meet the definition of new investigator. For 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, 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 applicant’s name. Multiple PIs have the same leadership status on grants as individual PIs; therefore, applicants 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). Applicants may submit or have an R01 (or equivalent) grant application pending concurrently with their New Innovator Award application. However, if that pending grant is awarded in Fiscal Year 2008 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.

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. Awardees are required to commit at least 25% of their research effort each year to the project supported by the New Innovator Award.

There are no citizenship or residency requirements.

For more detail regarding eligibility requirements, see FAQs on the New Innovator web site at http://grants.nih.gov/grants/new_investigators/innovator_award/faq_2008.htm.

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the current NIH Grants Policy Statement.

3. Other-Special Eligibility Criteria

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. All applications for the 2008 New Innovator Award will be considered as new applications, regardless of any previous applications 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, link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site. See the detailed instructions below regarding choosing an application package (Section 1 Request Application Information).

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

PDs/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.

Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:

1) Organizational/Institutional Registration in Grants.gov/Get Started

2) Organizational/Institutional Registration in the eRA Commons

3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

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

Applicants must download the SF424 (R&R) application forms and SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply. After clicking Apply for Grant Electronically, applicants will be presented with a list of ten application packages corresponding to ten scientific areas, as described in the Special Instructions in Section 2 below. (The selection of scientific area by applicants is solely to aid in selection of the most appropriate group of peer reviewers. The 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.

For further assistance, contact GrantsInfo: Telephone 301-710-0267, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Prepare all 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 application to NIH. There are fields within the SF424 (R&R) application components that, 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) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include the following components:

Required Components:
SF424 (R&R) (Cover component)
Research & Related Other Project Information
Research & Related Senior/Key Person

Optional Components:
PHS398 Cover Letter File

When submitting a Changed/Corrected Application after the submission date, a cover letter is required explaining the reason for the Changed/Corrected Application. If you already submitted a cover letter with a previous submission and are now submitting a Changed/Corrected Application, you must include all previous cover letter text in the revised cover letter attachment. The system does not retain any previously submitted cover letters; therefore, you must repeat all information previously submitted in the cover letter as well as any additional information. Cover letters are not required when submitting changed/corrected applications before the receipt deadline.

SPECIAL INSTRUCTIONS

The Commons ID of the PD/PI must be included in the Credential field of the Research & Related Senior/Key Person component. Failure to include this data field will cause the application to be rejected.

Applications proposing multiple PIs are not allowed.

The application to be submitted to Grants.gov must include:

Area of Science Selection: In order to assist NIH staff in assigning applications to the most appropriate reviewers, applicants will designate their area of science by choosing one of ten application packages in Grants.gov. After clicking Apply for Grant Electronically, applicants will be presented with a list of ten application packages, each with a separate Competition ID and Title . Each application package corresponds to one of the science areas listed below.

Areas of Science:

01 Behavioral and Social Sciences

02 Chemical Biology

03 Clinical and Translational Research

04 Epidemiology

05 Immunology

06 Instrumentation and Engineering

07 Molecular and Cellular Biology

08 Neuroscience

09 Physiology and Integrative Systems

10 Quantitative and Computational Biology

Effort Commitment: Awardees are required to commit at least 25% 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 25% of his/her research effort to the project supported by the New Innovator Award.

An abstract of no more than 300 words (not to exceed one page) describing the goals of the project.

An essay of no more than 10 pages that addresses (1) the significance of the project, (2) what makes the approaches exceptionally innovative and how the applicant 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 not 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 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:

Preliminary data are allowed but not required. Bibliographic citations (references), 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.

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.) Any request for an exception to the eligibility requirement of time from last doctoral degree must be specifically justified in this section of the 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 application is received. Applications from investigators who exceed the time from last doctoral degree or completion of medical internship/residency and who fail to provide a 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. No other biographical sketches are to be submitted.

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 URL in Section 3.1.1.8 of the Application Guide.) Applicants must include a statement that, if chosen to receive an award, the applicant will commit a minimum of 25% 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. This document is uploaded on the Research & Related Senior/Key Person Component form.

Special requirements for completing the SF424 (R&R) application are specified in Section IV.6, below. In addition:

The Budget request 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 (including co-investigators and collaborators), 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. A detailed budget is not requested and will not be accepted.

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.

Format specifications for Text (PDF) Attachments: All attachments must be in PDF format. Follow format specifications for PDF attachments in the Application Guide (http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_Ver2.pdf)

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Submission, Review, and Anticipated Start Dates
Opening Date: March 3, 2008 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): Not applicable
Application Submission/Receipt Date: March 31, 2008
Peer Review Date(s): May-June, 2008
Advisory Council to the Director Review Date(s): August, 2008
Earliest Anticipated Start Date: September 30, 2008

3.A.1. Letter of Intent

A letter of intent is not required for the funding opportunity and will not be accepted.

3.B. Submitting an Application Electronically to the NIH

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/Apply and follow steps 1-4. Also see Special Instructions in Section IV.2 of this FOA. Note: Applications must only be submitted electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED.

3.C. Application Processing

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 applicant institution/organization) on the application submission/receipt date. (See Section IV.3.A. for all dates.) If an application is not submitted by the receipt date and time, the application may be delayed in the review process or not reviewed.

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.

Upon receipt, applications will be evaluated for completeness by NIH staff. Incomplete applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. Information related to the assignment of an 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 his/her application status in the Commons.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

6. Other Submission Requirements

PD/PI Credential (e.g., Agency Login)

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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