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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: 2007 NIH Director's New Innovator Award Program (DP2)

Announcement Type

New

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-07-009

Catalog of Federal Domestic Assistance Number(s)
93.310

Key Dates
Release/Posted Date: March 9, 2007
Opening Date: April 25, 2007 (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 Receipt Date(s): May 22, 2007
Peer Review Date(s): July 2007
Advisory Council to the Director Date(s): August 2007
Earliest Anticipated Start Date(s): September 28, 2007
Additional Information to be Available: March 9, 2007 Frequently Asked Questions (FAQs) are available at http://grants.nih.gov/grants/new_investigators/innovator_award/faq.htm
Expiration Date: May 23, 2007

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. 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 highly innovative approaches that have the potential to produce an unusually high impact on significant contemporary 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 New Innovator Award will emphasize the importance and potential impact of the scientific problem, the novelty and innovativeness of the approach and the applicant’s potential for creative and innovative research. Presentation of preliminary data relevant to the project will be allowed, but is not required.

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 to provide additional means to identify scientists with ideas that have the potential for high impact, but may be too novel, span too diverse a range of disciplines, or be at a stage too early to fare well in the traditional peer review process. This year, NIH is conducting the fourth Pioneer Award competition to promote exceptional creativity and innovation in biomedical research.

The research enterprise of the future also depends on the next generation of biomedical and behavioral investigators. As part of its commitment to increasing the success of new investigators, NIH last year created the NIH Pathway to Independence Award (K99/R00; http://grants.nih.gov/grants/new_investigators/pathway_independence.htm) to facilitate the transition from a mentored postdoctoral position to the first independent research position.

This year, NIH has created the NIH Director’s New Innovator Award (http://grants.nih.gov/grants/new_investigators/innovator_award/ ) to support exceptionally creative new investigators who propose highly innovative approaches that have the potential to produce an unusually high impact, but where preliminary data required for a traditional R01 grant may not be available. This new program is intended to address both the goals of stimulating the application of innovative research approaches to important biomedical and behavioral research problems and nurturing unusually creative investigators at the early stages of their research careers.

This FOA announces the first NIH Director’s New Innovator Award competition for at least 14 awards of up to $1.5 million for a five-year period (an average annual budget of up to $300,000 direct costs) plus applicable Facilities and Administrative costs. Awards will be made in Fiscal Year 2007. Applicants must hold an independent research position at a domestic (U.S.) institution as of September 20, 2007, must have received their most recent doctoral degree (e.g., Ph.D., M.D., D.D.S, D.V.M, or equivalent) or completed their medical internship and residency in 1997 or later, and must commit at least 30% of their research effort to the project supported by the New Innovator Award. 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, R37, U01) or leader of a P01 or center grant peer-reviewed project. Individuals who are unable to meet these requirements should not apply. Any request for an exception to the eligibility requirement of time from last professional degree must be based upon additional clinical training or unusual circumstances. Requests must be justified in the Biographical Sketch, and will be considered on a case-by-case basis.

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

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.

2. Funds Available

Total funding available for this five-year program is at least $40 million for the five-year period. It is anticipated that at least 14 awards will be made.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit an application(s) if your institution/organization is a domestic (U.S.) 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

Applicant PD/PI’s must hold an independent research position at a domestic (U.S.) institution as of September 20, 2007 and must have received their most recent doctoral degree (e.g., Ph.D., M.D., D.D.S., D.V.M., or equivalent) or completed their medical internship and residency in 1997 or later. Any request for an exception to the eligibility requirement of time from last professional degree must be based upon additional clinical training or unusual circumstances. Requests must be justified in the Biographical Sketch, and will be considered on a case-by-case basis. For the purpose of this FOA, independent research position means a position that is held by an investigator who is permitted by his/her institutional policy to apply for R01 grants, with an appropriate commitment of facilities to be used for the conduct of the proposed research.

Applicants must meet the definition of new investigator. For the purpose of this FOA, new investigators are defined as those applicants who have never been PI on an R01 or equivalent grant (e.g., R23, R29, R37, U01) or leader of a P01 or center grant peer-reviewed project. Applicants may submit or have an R01 grant application pending concurrently with their New Innovator Award application. The proposed research need not be in a conventional biomedical or behavioral discipline, but must be relevant to the mission of NIH. 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 30% of their research effort to the project supported by the New Innovator Award. Women and members of groups underrepresented in biomedical or behavioral research are especially encouraged to apply. There are no citizenship or residency requirements.

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

Not applicable.

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.

A one-time registration for institutions/organizations is required 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.

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.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be usable for more than one FOA.

For further assistance, contact GrantsInfo: Telephone 301-710-0267, Email: [email protected].

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

2. Content and Form of Application Submission

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

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

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

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

Optional Components:
PHS 398 Cover Letter Component

Note: Cover letters should be included only when submitting changed/corrected or late applications. Do not submit cover letters with initial submissions.

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

(Use the format shown in Part III of the Application Guide.) This document is uploaded on the Research & Related Senior/Key Person Component form.

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

Format specifications for Text (PDF) Attachments: All attachments must be in PDF format. Follow format specifications for PDF attachments on page I-17 in the Application Guide.) Fonts: Use an Arial, Helvetica, Palatino, Linotype, or Georgia typeface, a black font color, and a font size of 11 points or larger. Type density: Including characters and spaces, must be no more than 15 characters per inch. Type may be no more than six lines per inch. Page margins: Use standard paper size (8 x 11). Use at least one-half inch margins (top, bottom, left, and right) for all pages. Avoid using a two-column format as it can cause difficulties when reviewing the document electronically. Do not include any information in a header or footer of the attachment. A header will be self-generated that references the name of the PD/PI. Page numbers for the footer will be system-generated in the complete application, with all pages sequentially numbered.

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

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, supplies, equipment, sub-contracts, and other allowable costs. You should estimate the direct costs for each year, and sum them to derive the five-year total. Only the five-year total should be entered on Line 16a and b and must not add up to more than $1.5 million. No detailed budget is requested, and will not be accepted.

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Submission, Review, and Anticipated Start Dates
Opening Date: April 25, 2007 (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 Receipt Date(s): May 22, 2007
Peer Review Date(s): July 2007
Advisory Council to the Director Date(s): August 2007
Earliest Anticipated Start Date(s): September 28, 2007

3.A.1. Letter of Intent

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

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

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 and eligibility 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 their 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. The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Registration FAQs Important Tips -- Electronic Submission of Grant Applications.

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.

Research Plan Component Sections

Not applicable.

All application instructions outlined in the SF 424 (R&R) Application Guide are to be followed, incorporating Just-in-Time information concepts, with the following additional requirements for New Innovator Award applications. Applications that do not conform to the specific instructions detailed below will not be reviewed.

1. SF424 (R&R) (COVER COMPONENT): Enter title of applicant’s project. DO NOT include the two-digit Area of Science code at the beginning of this title. This title is for use solely by the applicant for tracking the application through the Grants.gov submission process. It has different length requirements and does not need to match the full title in Item 11 below.

Fill out each section using the instructions below. Note that items that are starred (*) in the application are mandatory.

Item Number and Title

Instructions

1. Type of Submission

Check Application . (See Section IV. 3C for information on Changed/Corrected Applications.)

2. Date Submitted

Enter date in this format: mm/dd/yyyy.

Applicant Identifier

Optional for applicant institution use

3. Date Received by State

Leave blank.

State Application Identifier

Leave blank

4. Federal Identifier

For initial submission leave blank; for Changed/Corrected submissions, enter Grants.gov tracking number of initial submission

5. Applicant Information

Enter information for Applicant Organization

Organizational DUNS

Must match the number entered in the eRA Commons Institutional Profile for the applicant organization.

Legal Name

Enter the legal name of the Applicant Organization

Department

Enter the name of the primary organizational department, service, laboratory, or equivalent level within the organization that will undertake the assistance activity.

Division

Enter the name of the primary organizational division, office, or major subdivision that will undertake the assistance activity.

Address

Enter the address for the Applicant Organization

Person to be contacted on matters involving this application

Enter information for the Administrative or Business Official, not the PD/PI. This person is the individual to be notified if additional information is needed and/or if an award is made.

6. Employer Identification Number (EIN or TIN)

Enter the EIN or TIN as assigned by the Internal Revenue Service. If you have a 12-digit EIN established for grant awards from NIH or other PHS agencies, enter all 12 digits.

7. Type of Applicant

This information is for the Applicant Organization, not a specific individual.

8. Type of Application

Must be New

9. Name of Federal Agency

Pre-populated

10. Catalog of Federal Domestic Assistance Number

Pre-populated: 93.310 Trans-NIH Research Support

11. Descriptive Title of Applicant’s Project

Limited to 81 characters, including spaces and punctuation. IN FRONT OF TITLE, enter two-digit code for Area of Science, followed by a hyphen. Enter two digits only, no letters or spaces between code, hyphen and title (e.g., 02-Cure of the Common Cold). Only one area may be selected.

  • 01 Behavioral and Social Sciences
  • 02 Clinical and Translational Research
  • 03 Instrumentation and Engineering
  • 04 Molecular Biology
  • 05 Cellular Biology
  • 06 Chemical Biology
  • 07 Pathogenesis
  • 08 Epidemiology
  • 09 Physiology and Integrative Systems
  • 10 Quantitative and Computational Biology

12. Areas Affected by Project

Enter n/a for not applicable

13. Proposed Project

Enter start date: 09/28/2007; Enter end date: 08/31/2012

14. Congressional Districts of
a. Applicant

Enter the Congressional District in the format: 2 character State Abbreviation 3 character District Number. Examples: CA-005 for California’s 5th district, CA-012 for California’s 12th district. To locate your Congressional district, visit the Grants.gov Web site.

Congressional Districts of
b. Project

Enter the Congressional District in the format: 2 character State Abbreviation 3 character District Number. Examples: CA-005 for California’s 5th district, CA-012 for California’s 12th district. If all districts for a state are affected, enter all for the district number. Example: MD-all for all congressional districts in Maryland. If nationwide (all districts in all states) enter US-all. To locate your Congressional district, visit the Grants.gov Web site. Attach an additional list of Project Congressional Districts on page 2 (Item 21), if needed.

15. Project Director/Principal Investigator Contact Information

Enter information for PD/PI here.

16. Estimated Project Funding
a. Total Estimated Project Funding

Enter up to $1,500,000

b. Total Federal & Non-Federal Funds

Enter up to $1,500,000

c. Estimated Program Income

Enter 0 (Zero)

17. Is Application Subject to Review by State Executive Order 12372 Process?

Check No

18. Statement and Signatures (Complete Certification)

Read statement in box 18. Check I agree box to provide required certifications and assurances. This field is required.

19. Authorized Representative (Signing Official)

Completed by the AOR/SO.

20. Pre-Application

Leave Blank.

21. List of Project Congressional Districts

See item 14b above.

2. RESEARCH & RELATED OTHER PROJECT INFORMATION COMPONENT:

Fill out each section using the instructions below. Note that items that are starred (*) in the application are mandatory.

Item Number and Title

Instructions

1. Are Human Subjects Involved?

Check No (Note: This information will be requested at the time of award)

2. Are Vertebrate Animals Used?

Check No (Note: This information will be requested at the time of award)

3. 4.

Answer as appropriate.

5. a. Activities Outside U.S./International
Collaborators

Answer as appropriate.

5.b. Identify Countries

Enter the countries with which international cooperative activities are involved.

5.c. Optional Explanation

Do not use.

6. Project Summary/Abstract

Attach abstract. (Maximum of 300 words [no more than 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 bibliographic 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 may lead to rejection of the application during agency validation or delay in the review process.

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

Fill out each section using the instructions below. Note that items on the application that are starred (*) are mandatory.

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

Item Title

Instructions

Credential, e.g., agency login

Enter PD/PI’s eRA/Common’s UserName

Project Role

Prefilled

Other Project Role Category

Leave blank

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).

Attach Current & Pending Support

Attach a list of Current and Pending Support here (PDF format). Use the form shown in the URL in Section 4.5.2 of the Application Guide. Be sure to include statement affirming that you will devote at least 30% of research effort to New Innovator Award project. Also, 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.

Additional Senior/Key Person Profile(s)

Do not use.

Additional Biographical Sketch(es) (Senior/Key Person)

Do not use.

Additional Current and Pending Support(s)

Do not use.

Note: Applications found not to comply with the page limit requirements may lead to rejection of the application during agency validation or delay in the review process.

4. PHS 398 Cover Letter File (Optional):

Cover letters should be included only when submitting Changed/Corrected or late applications. Do not submit cover letters for initial submissions. The cover letter should contain only the following information:

1. PD/PI name

2. Funding Opportunity Title: 2007 NIH Director’s New Innovator Award Program (DP2)

3. For late applications, include an explanation of the delay. (See Late Application Policy in Section 2.14 of the Application Guide.)

4. For Changed/Corrected Applications 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.

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 electronically by a specially constituted, multidisciplinary group of outside experts. The Advisory Committee to the Director (ACD), NIH, will conduct the second level of review.

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. Also, reviewers will consider appropriateness of the New Innovator Award grant mechanism to support the proposed project. Specifically, reviewers will evaluate:

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.

Final selections will be publicly announced, and awards made, by the end of September 2007.

2.A. Additional Review Criteria:

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).

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2. B. Additional Review Considerations

Budget and Period of Support: The reasonableness of the proposed budget in relation to the proposed research may be assessed by the reviewers. The priority score will not be affected by the evaluation of the budget.

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, 2007, and awards will begin September 28, 2007.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, "just-in-time" information will be requested from the applicant. For details, applicants may refer to the 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 only authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official.

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.

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 30% of their research effort to the project supported by the New Innovator Award.

3. Reporting

Awardees will be required to submit a scientific progress report on June 1 of each year describing the progress made under this grant and to submit a final progress report, Final Invention Statement, and Financial Status Report at the end of the budget/project period.

Section VII. Agency Contacts

We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Direct inquiries, preferably by e-mail, to:

1. Scientific/Research 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: [email protected]

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: [email protected]

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: [email protected]

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.htm

Section VIII. Other Information

Required Federal Citations

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. A model organism sharing plan will be required if an award is to be made.

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.

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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NIH Funding Opportunities and Notices


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