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 301-435-0714, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-0088.

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)

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.

Organizational DUNS

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, Electronic Submission of Grant Applications.”

Follow all application instructions outlined in the SF 424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_Ver2.pdf) incorporating “Just-in-Time” information concepts, with the following exceptions, which are specific requirements for New Innovator Award applications. 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

8. Type of Application

Must be “New”

13. Proposed Project

Enter start date: 09/30/2008; Enter end date: 08/31/2013

16 Estimated Project Funding
16 a. Total Estimated Project Funding

Enter up to $1,500,000

16 b. Total Federal & Non-Federal Funds

Enter up to $1,500,000

2. RESEARCH & RELATED OTHER PROJECT INFORMATION COMPONENT:

Item Number and Title

Instructions

1. Are Human Subjects Involved?

Follow the Application Guide instructions for all fields in Section 1.a. Check “Yes” or “No” as appropriate. If “Yes”, enter “None,” or the IRB Approval Date, Exemption Number, and Human Subject Assurance Numbers may be entered but are not required at the time of submission. Detailed plans regarding protection of human subjects, inclusion of women and minorities, targeted/planned enrollment, and inclusion of children are not required at the time of submission. This information will be requested on a just-in-time basis at the time of award.

2. Are Vertebrate Animals Used?

Follow the Application Guide instructions for all fields in 2.a. Check “Yes” or “No” as appropriate. Detailed plans regarding the use of vertebrate animals are not required at the time of submission. Enter “None.” The IACUC Approval Date and Animal Welfare Assurance Numbers may be entered but are not required at the time of submission. This information will be requested on a just-in-time basis at the time of award.

6. Project Summary/Abstract

Attach abstract. (Maximum of 300 words [not to exceed one page]; PDF format)

7. Project Narrative

Attach essay (Maximum of ten pages; 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: 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.

3. 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 (PDF format). Use the form shown in the URL in Section 3.1.1.8 of the Application Guide. Be sure to include 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: Applications found not to comply with the page limit requirements will be rejected during the agency validation process.

4. PHS 398 Cover Letter File (Optional):

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

1. PD/PI name.

2. Funding Opportunity Title: 2008 NIH Director’s New Innovator Award Program (DP2).

3. For Changed/Corrected Applications submitted after the submission deadline, include an explanation of the reason for the Changed/Corrected Application.

(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.)

Letters of Reference:

Letters of reference are not required and will not be accepted.

PHS398 Research Plan Component Sections:

Not applicable.

Appendix Materials:

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

Plan for Sharing Research Data

Not applicable.

Sharing Research Resources

Not applicable.

Section V. Application Review Information

1. Criteria

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

2. Review and Selection Process

Applications that are complete and responsive to the FOA will be evaluated by a specially constituted, multidisciplinary group of outside experts. The reviews will be conducted electronically. 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’s potential for creative and innovative research as a “new investigator.” Specifically, reviewers will evaluate:

The Advisory Committee to the Director (ACD), NIH, will conduct the second level of review.

The following will be considered in making funding decisions:

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.

Since the New Innovator Award applications are reviewed differently from other NIH grant mechanisms, priority scores and percentiles are not assigned. Applicants will not receive review scores or comments. There is no appeals process.

Final selections will be publicly announced, and awards made, by the end of September 2008.

2.A. Additional Review Criteria:

NOTE: 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.

Protection of Human Subjects from Research Risk: 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).

Inclusion of Women, Minorities and Children in Research: 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)

Care and Use of Vertebrate Animals in Research: 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).

2.B. Additional Review Considerations

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

2.C. Sharing Research Data

Not Applicable

2.D. Sharing Research Resources

Not Applicable

3. Anticipated Announcement and Award Dates

Awardees will be notified in September, 2008, and awards will begin September 30, 2008.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.

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 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.

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 Section IV.5., “Funding Restrictions.”

Following award, the New Innovator Awards will be administered by the institute or center (IC) whose mission most closely matches that of the research area of the grant. Awardees will be notified of the IC and the grants management and program contacts.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities.

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.

2a. When issuing statements, press releases, and other documents describing projects or programs funded as a NIH Director’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 http://grants.nih.gov/grants/new_investigators/innovator_award/.”

2b. As indicated in the FOA, awardees are expected to commit at least 25% of their research effort to the project supported by the New Innovator Award.

2c. Awardees are expected to attend an annual symposium in the Bethesda, MD, area.

2d. Since the full budget/project period funding for this award is issued from one fiscal year’s appropriation, an extension of time for a period after August 31, 2013 is not allowable. Therefore, it is imperative that the Final Financial Status Report and the Federal Cash Transactions Report be submitted by September 30, 2013.

3. Reporting

Awardees will be required to submit a scientific progress report on September 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. Information about the where to submit progress reports and other documentation will be provided at the time of award.

Section VII. Agency Contacts

Many questions are addressed in the FAQs on the New Innovator web site at http://grants.nih.gov/grants/new_investigators/innovator_award/faq_2008.htm. We encourage any remaining inquiries concerning this funding opportunity (e-mail is strongly preferred) and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Judith H. Greenberg, Ph.D.
Director, Division of Genetics and Developmental Biology
National Institute of General Medical Sciences
National Institutes of Health
Building 45, Room 2As25, MSC 6200
Bethesda, Maryland 20892-6200
Phone: 301-594-4469
Email: newinnovator@nih.gov (e-mail is the strongly preferred method for inquiries)

2. Peer Review Contact:

Judith H. Greenberg, Ph.D.
Director, Division of Genetics and Developmental Biology
National Institute of General Medical Sciences
National Institutes of Health
Building 45, Room 2As25, MSC 6200
Bethesda, Maryland 20892-6200
Phone: 301-594-4469
Email: newinnovator@nih.gov (e-mail is the strongly preferred method for inquiries)

3. Financial/Grants Management Contact:

Marcia F. Cohn
Grants Management Officer
National Institute of General Medical Sciences
National Institutes of Health
Building 45, MSC 6200
Bethesda, Maryland 20892-6200
Phone: 301-594-3918
FAX: 301-480-2554
Email: cohnm@mail.nih.gov

Information about the New Innovator Awards is at http://grants.nih.gov/grants/new_investigators/innovator_award/.

Please see the Frequently Asked Questions (FAQs) on the New Innovator web site at http://grants.nih.gov/grants/new_investigators/innovator_award/faq_2008.htm

Section VIII. Other Information

Required Federal Citations

Information responsive to the following federal citations should not be submitted with the application. Just-in-time information will be requested for those applications being considered for funding.

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

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).

Sharing Research Data:

Not applicable.

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.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). 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 NIH Grants Policy Statement. Beginning October 1, 2004, all investigators submitting an NIH application or contract proposal are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

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:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) 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.

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.

For more information about the Policy or the submission process, please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view the Policy or other Resources and Tools, including the Authors' Manual.

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. Publicly accessible on-line journal articles or PubMed Central (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 essay 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 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 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.

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