Part I Overview Information


Department of Health and Human Services

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

Title:  Pre-Application for the 2009 NIH Director’s New Innovator Award Program (X02)

Announcement Type

New

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

Program Announcement (PAR) Number: PAR-09-013

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.

Catalog of Federal Domestic Assistance Number(s)
93.310

Key Dates
Release/Posted Date: October 23, 2008
Opening Date:  December 15, 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 Due Date(s):  January 15, 2009
Peer Review Date(s): April 2009 
Council Review Date: Not Applicable
Earliest Anticipated Start Date(s): Not Applicable
Additional Information To Be Available: October 31, 2008 – Frequently Asked Questions (FAQs) at http://nihroadmap.nih.gov/newinnovator 
Expiration Date: January 16, 2009

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

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. Receipt, 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 and Information

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices

2. Administrative and National Policy Requirements
3. Reporting

Section VII. Agency Contacts
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.

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.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information


1. Mechanism of Support

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.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

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

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 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.

There are no citizenship or residency requirements.

For more detail regarding eligibility requirements, see FAQs on the New Innovator web site at http://nihroadmap.nih.gov/newinnovator/faq2009.aspx. 

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

Resubmissions of pre-applications are not allowed.

Pre-applications to renew a DP2 award are not allowed.

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:

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

Several additional separate actions are required before an investigator can submit an electronic pre-application, as follows:  

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

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

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/ApplyAfter 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.

For further assistance, contact GrantsInfo -- Telephone 301-435-0714; Email: GrantsInfo@nih.gov.

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

2. Content and Form of Application Submission

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/APPLY includes all applicable components, required and optional. A completed pre-application in response to this FOA includes the data in the following components:

Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan

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 instructions are 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:

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

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 is the indicated 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:

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:

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

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:

1. PD/PI name.

2. Funding Opportunity Title: Pre-Application for the 2009 NIH Director’s New Innovator Award Program (X02).

3. For Changed/Corrected Pre-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.)

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.

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review, and Anticipated Start Dates
Opening Date: December 15, 2008 (Earliest date an application may be submitted to Grants.Gov)
Letters of Intent Receipt Date: Not applicable
Pre-Application Due Date: January 15, 2009
Peer Review Date: April 2009
Council Review Date: Not Applicable
Earliest Anticipated Start Date: Not Applicable

3.A.1. Letter of Intent

A letter of intent is not required for the funding opportunity.

3.B. Submitting an Application Electronically to the NIH

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.

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.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

Not Applicable

6. Other Submission Requirements and Information

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

The NIH requires the PD(s)/PI(s) 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 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:

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:

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:

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:

1. Scientific/Research Contact(s):

Richard Okita, Ph.D.
Program Director, Pharmacological and Physiological Sciences Branch
National Institute of General Medical Sciences
National Institutes of Health
Building 45, Room 2As49, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-4469
Email: newinnovator@nih.gov (e-mail is the strongly preferred method for inquiries)  

2. Peer Review Contact(s):

Richard Okita, Ph.D.
Program Director, Pharmacological and Physiological Sciences Branch
National Institute of General Medical Sciences
National Institutes of Health
Building 45, Room 2As49, MSC 6200
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Telephone: (301) 594-4469
Email: newinnovator@nih.gov (e-mail is the strongly preferred method for inquiries):

Section VIII. Other Information


Required Federal Citations

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. 

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).

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/.


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