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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 Common Fund initiative (http://nihroadmap.nih.gov) through the Office of Strategic Coordination (http://dpcpsi.nih.gov/osc). All NIH Institutes and Centers participate in Common Fund initiatives. This FOA is being administered by the National Institute of General Medical Sciences (NIGMS), (http://www.nigms.nih.gov/) on behalf of NIH.

Title: 2011 NIH Director’s New Innovator Award Program (DP2)

Announcement Type
This is a reissue of RFA-RM-09-011.

Update: The following updats relating to this announcement have been issued:

Request for Applications (RFA) Number: RFA-RM-10-009

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 (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: July 12, 2010
Opening Date: August 20, 2010 (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): September 20, 2010
Peer Review Date(s): April 2011
Council Review Date(s): May 2011
Earliest Anticipated Start Date(s): September 1, 2011
Additional Information To Be Available Date (July 12, 2010): Frequently Asked Questions (FAQs) at http://nihroadmap.nih.gov/newinnovator/faq.asp
Expiration Date: September 21, 2010

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
1. Mechanism of Support
2. Funds Available

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

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
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

This initiative is part of a series of programs known collectively as the NIH Common Fund programs (http://nihroadmap.nih.gov/). Common Fund programs are designed to foster new ways of doing research, to fill fundamental knowledge gaps, and to encourage risk taking to solve complex problems. The overarching criterion for Common Fund programs is that they are expected to transform the way research is conducted across the spectrum of health research. The programs in their entirety therefore do not address specific diseases or conditions, although individual awards within a program may be disease- or condition-specific. The NIH Director’s New Innovator Award Program is a High-Risk Research initiative of the Common Fund.

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. Investigators who were not selected for an award in prior years may submit applications this year as long as they retain their ESI (early stage investigator) eligibility; however, all applications must be submitted as new applications regardless of any previous submission to the program.

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

Section II. Award Information

1. Mechanism of Support

This FOA will use the DP2 award mechanism. The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.

This FOA uses Just-in-Time information concepts (see SF424 (R&R) Application Guide). Budgets are not required and will not be accepted.

2. Funds Available

This is a Common Fund initiative. The NIH Common Fund has set aside sufficient funds in FY2011 to support at least 33 awards, contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.

Awards will be for $300,000 in direct costs each year for five years, plus applicable Facilities and Administrative (F&A) costs to be determined at the time of award.

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

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

Foreign (non-U.S.) 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, and who meets the eligibility criteria below, is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. Multiple PDs/PIs are not allowed.

Applicants must meet the definition of an Early Stage Investigator (ESI). An ESI is a new investigator (defined as a PD/PI who has not completed successfully for a significant NIH independent research award) who is within 10 years of completing his/her terminal research degree or is within 10 years of completing medical residency (or the equivalent). Frequently Asked Questions about the NIH Early Stage Investigator (ESI) Policy can be found at http://grants.nih.gov/grants/new_investigators/.

An extension to the 10-year period may be granted under special circumstances (e.g., family care responsibilities, extended periods of clinical training, disability or illness, etc). To request an extension, an applicant MUST complete the Form for Requesting an Extension in the Early Stage Investigator (ESI) Period (http://grants.nih.gov/grants/new_investigators/esi_extension_add.htm). A request for extension must be approved at the time the New Innovator Award application is submitted. It may take up to several weeks for the approval process, so applicants should plan accordingly.

Applicants are responsible for reviewing and/or updating their degree information in their eRA Commons account in a timely fashion (refer to NIH Notice NOT-OD-09-021). Applicants should allow two weeks for an extension request to be processed. NOTE: If an applicant is not identified as an ESI in the eRA Commons, it may result in the application not being reviewed.

Applicants also must hold an independent research position at a domestic (U.S.) institution as of September 1, 2011. For the purpose of this FOA, independent research position means a position that automatically confers eligibility, by the applicant’s institutional policy, for an investigator to apply for R01 grants, with an appropriate commitment of facilities to be used for the conduct of the proposed research. Investigators still in training or mentored status (postdoctoral fellows) are not eligible to apply unless they have a written commitment of an independent faculty position as of September 1, 2011 that is certified by submission of the application from that institution.

Applicants must never have been the PI on an R01 equivalent grant (e.g., R23, R29, R33, R42, DP1, DP2, RC1, RC2, U01, P01 or center grant) or leader of a P01 or center grant peer-reviewed project that was reviewed in the applicant’s name. Multiple PIs have the same leadership status on grants as individual PIs; therefore, applicants who have served as one of multiple PIs on any ineligible grant are no longer considered new investigators and are not eligible to apply for a New Innovator Award. Applicants may submit or have an R01 (or other equivalent) grant application pending concurrently with their New Innovator Award application. However, if that pending grant is awarded in Fiscal Year 2011 with a start date of September 30 or earlier, the applicant is no longer eligible to receive the New Innovator Award.

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

There are no U.S. citizenship or residency requirements.

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

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

Number of Applications. Applicants may submit only one application as a PD/PI in response to this FOA. There is no limit to the number of applications that an institution may submit

Resubmissions. Resubmission applications are not permitted in response to this FOA.

Renewals. Renewal applications are not permitted in response to this FOA.

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.

Registration:

Appropriate registrations with Grants.gov and eRA Commons must be completed on or before the due date in order to successfully submit an application. 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 with both Grants.gov and the Commons. All registrations must be complete by the submission deadline for the application to be considered on-time (see 3.C.1 for more information about on-time submission).

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 applicant can submit an electronic 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: The registration process is not sequential. Applicants should begin the registration processes for both Grants.gov and eRA Commons as soon as their organization has obtained a DUNS number. Only one DUNS number is required and the same DUNS number must be referenced when completing Grants.gov registration, eRA Commons registration and the SF424 (R&R) forms.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and the 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 useable 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 for this FOA through Grants.gov/Apply and in accordance with the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/index.htm).

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate 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) 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 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:
PHS398 Cover Letter File IMPORTANT: Special instructions for Pioneer Award applications are given in Section 6 ( Other Submission Requirements ). Detailed budgets are not required 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: August 20, 2010 (Earliest date an application may be submitted to Grants.gov) Application Due Date(s): September 20, 2010
Peer Review Date(s): April 2011
Council Review Date(s): May 2011
Earliest Anticipated Start Date(s): September 1, 2011

3.A.1. Letter of Intent

A letter of intent is not required and will not be accepted.

3.B. Submitting an Application Electronically to the NIH

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/applicants/apply_for_grants.jsp and follow Steps 1-4. Note: Applications must only be submitted electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.

3.C. Application Processing

3.C.1 Submitting On-Time

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 due date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the due date(s) and time, the application may be delayed in the review process or not reviewed. All applications must meet the following criteria to be considered on-time :

Please visit http://era.nih.gov/electronicReceipt/app_help.htm for detailed information on what to do if Grants.gov or eRA system issues threaten your ability to submit on time.

Submission to Grants.gov is not the last step applicants must follow their application through to the eRA Commons to check for errors and warnings and view their assembled application!

3.C.2 Two Day Window to Correct eRA Identified Errors/Warnings

IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.

Once an application package has been successfully submitted through Grants.gov, NIH provides applicants a two day error correction window to correct any eRA identified errors or warnings before a final assembled application is created in the eRA Commons. The standard error correction window is two (2) business days, beginning the day after the submission deadline and excluding weekends and standard federal holidays. All errors must be corrected to successfully complete the submission process. Warnings will not prevent the application from completing the submission process.

Please note that the following caveats apply:

3.C.3 Viewing an Application in the eRA Commons

Once any eRA identified 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 weekdays (Monday Friday, excluding Federal holidays) to view the assembled application before it automatically moves forward to NIH for further processing.

Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the IC. Incomplete and/or non-responsive applications will not be reviewed.

There will be an acknowledgement of receipt of 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 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 the application status in the Commons.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, 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 funding opportunity 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

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

Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new award if such costs: 1) are necessary to conduct the project, and 2) would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project (see the NIH Grants Policy Statement).

6. Other Submission Requirements

SPECIAL INSTRUCTIONS

Information for PD/PI should be entered on the SF424 (R&R) Cover component. The Commons ID of the PD/PI must be included in the Credential field of the Research & Related Senior/Key Person component. Failure to include this data field will cause the application to be rejected.

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

Please note that the application components, required documents, and location of uploads have been changed from previous years. Carefully review the instructions below to ensure that the required documents are uploaded to the appropriate fields.

DOCUMENTS TO BE UPLOADED: The following table is a summary of the documents that must be uploaded to the application. Detailed instructions for completing each application component are below.

Document Name

Form/Field

Special Instructions

Abstract

R&R Other Project Information Component, Field 7 (Project Summary/Abstract)

30 lines of text maximum

Public Health Relevancy Statement

R&R Other Project Information Component, Field 8 (Project Narrative)

2 3 sentences maximum

Facilities & Other Resources

R&R Other Project Information Component, Field 10 (Facilities and Other Resources)

One page maximum

Biographical Sketch

SF 424 R&R Senior/Key Person Profile, field titled Attach Biographical Sketch

Two pages maximum; omit section D Other Support (Current and Pending Support information submitted separately see below)
Submit only for PD/PI

List of Current and Pending Research Support

SF424 Senior/Key Person Profile Component

Provide current year direct costs to applicant and percent effort for each project. Include statement that at least 25% of research effort will be for New Innovator Award research.

Essay

PHS 398 Research Plan, Field 2.3 (Research Strategy)

Ten pages maximum; must include science area (1-digit code and name of science area at beginning of essay). No Specific Aims pages should be provided.

Human and Vertebrate Animal Subjects Plans (If applicable)

PHS 398 Research Plan Component, Fields 6-10

Complete instructions for the PHS398 Research Plan component are in the SF424 Application Guide, Section I, part 5 (Competing PHS 398 Components) see page I-109. There are also supplemental instructions for preparing the human subjects plan in Part II of the Application Guide.

Note: All documents must be in PDF format and must comply with prescribed page limits. No additional documents should be uploaded to the application and applications that contain additional materials may not be reviewed. (See detailed information on each application component below)

1. SF424 (R&R) COVER COMPONENT:

Item Number 4.b: Agency Routing Identifier: Enter Science Area Designation: Designate one scientific area from the list below by entering the one-digit code and name of scientific area (e.g., 1 Behavioral and Social Sciences). Choose the one area that best describes your proposed research.

1 Behavioral and Social Sciences
2 Chemical Biology
3 Clinical and Translational Research
4 Immunology
5 Instrumentation and Engineering
6 Molecular and Cellular Biology
7 Neuroscience
8 High Throughput and Integrative Biology
9 Quantitative and Computational Biology

The areas of science listed are very broad and frequently overlapping. New Innovator Award reviewers are chosen for their breadth of knowledge and expertise and will be able to review a broad range of applications. Choose the one science area that is most appropriate for your proposed project.

IMPORTANT: Enter only the one-digit code followed by one space and then the name of the science area (exactly as shown above); do not use quotation marks, dashes, or other characters.

Correct: 1 Behavioral and Social Sciences

Incorrect: 1 Behavioral and Social Sciences ; 1 Behavioral and Social Sciences; 1: Behavioral and Social Sciences

The selection of scientific area by applicants is solely to aid in selection of the most appropriate group of peer reviewers and does not in itself affect an application’s funding potential. The application requirements and instructions are identical for all the science areas. All nine scientific areas are considered as a single competition, are reviewed in the same time period and by the same panel, and compete for a single source of funds.

Note: The science area designation (one digit code and name of science area) must also be included at the beginning of the Essay.

NOTE: The science areas and the procedure for designating a science area have been changed from previous years. See the frequently asked questions on the New Innovator Award website (http://nihroadmap.nih.gov/newinnovator/faq.asp).

Item Number 8. Type of Application: Must be New .

Item Number 13. Proposed Project: Enter start date: 09/30/2011; Enter end date: 7/31/2016.

Item Number 16. Estimated Project Funding: Enter $1,500,000.

Item Number 16a. Total Estimated Project Funding: Enter $1,500,000. (See note below.)

Item Number 16b. Total Federal & Non-Federal Funds: Enter $1,500,000.

Note: The Budget Request is entered only on Line 16a and b, as described above. Funds may be requested for personnel (including co-investigators and collaborators), supplies, equipment, sub-contracts, and other allowable costs. Only the five-year total $1.5 million -- should be entered on Line 16a and b. Applicable Facilities and Administrative (F&A) costs will be determined at the time of award and should not be included in the budget request. A detailed budget is not requested and will not be accepted.

2. Research & Related Project/Performance Site Locations Component: Complete all required fields as indicated on the form.

3. R&R Other Project Information Component:

Fields 1- 6.b. - Complete as required on the form.

Field 7: Project Summary/Abstract: Attach abstract of 30 lines or less describing the goals of the project. Text only no figures, animations, videos, or Web links are allowed

eSubmission is validating 30 lines of text

Field 8: Project Narrative: Upload PHR statement to field 8. In 2 3 sentences using plain language, describe how the proposed research can positively impact public health.

Field 9: Bibliography & References Cited: DO NOT USE. Reference citations are not required, but may be included in the essay and will be included in the ten-page limit.

Field 10: Facilities & Other Resources Statement: Upload a brief statement (1 page maximum) of the facilities to be used for the conduct of the research in the List of Current and Pending Research Support document.

Field 11 Equipment: DO NOT USE.

Field 12. Other Attachments: DO NOT USE.

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

Profile PD/PI Attach Biographical Sketch: Attach PD/PI s biographical sketch, two pages maximum, using the sample format on the Biographical Sketch Format Page shown in the Application Guide, Section 4.5. omitting Section D - Research Support. No biographical sketches of potential collaborators or other key personnel are to be submitted and will not be accepted. Information on potential collaborators is not required but may be included in the Essay.

Profile PD/PI Attach Current and Pending Support: Attach a list of Current and Pending Support from all sources, including current year direct costs and percent effort devoted to each project. Use the format shown in Section 3.1.1.8 of the Application Guide. A statement must be included that, if chosen to receive an award, the applicant will commit a minimum of 25% of his/her research effort to the project supported by the New Innovator Award.

Profile Senior Key Person 1: DO NOT USE. Submit information only for PD/PI. Information on collaborators or other key personnel is not required but may be included in the Essay.

5. PHS 398 Cover Page Supplement

Complete all required fields as indicated on the form.

6. PHS 398 Research Plan Component

Field 2. Research Plan Attachments:

UPLOAD DOCUMENTS TO ONLY THE FOLLOWING FIELDS:

2.3 - Research Strategy upload Essay here. See detailed instructions for Essay below.

2.6 - Protection of Human Subjects upload Human Subjects Plan per the instructions in the Application Guide, Part II, Supplemental Instructions for Preparing the Human Subjects Section of the Research Plan.

2.7 - Inclusion of Women and Minorities upload, as necessary, a section entitled Inclusion of Women and Minorities, per the instructions in the Application Guide, Part II, Supplemental Instructions for Preparing the Human Subjects Section of the Research Plan.

2.8 - Targeted/Planned Enrollment Table upload, as necessary, Targeted/Planned enrollment tables, per the instructions in the Application Guide, Part II, Preparing the Human Subjects Section of the Research Plan.

2.9 - Inclusion of Children upload, as necessary, a section entitled Inclusion of Children, per the instructions in the Application Guide, Part II, Preparing the Human Subjects Section of the Research Plan.

2.10 - Vertebrate Animals upload, as necessary, a Vertebrate Animals Use Plan, per the instructions in the Application Guide. You must address the five points as indicated in the Application Guide, Part I.5, pages 112-113.

2.11 - Select Agent Research upload the requested information per the instructions in the Application Guide, Part I.5, pages 113-114.

DO NOT USE OR UPLOAD ANY ATTACHMENTS TO THE FOLLOWING FIELDS:

2.1 Introduction to Application
2.2 Specific Aims
2.4 Inclusion Enrollment Report
2.5 Progress Report Publication List
2.12 Multiple PD/PI Leadership Plan
2.13 Consortium/Contractual Arrangements
2.14 Letters of Support

Detailed Instructions for Essay:

Submit 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 applicant will address risks and challenges, and (3) the applicant s qualifications for this award. The description of the scientific plan should be 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 applications, presentation of the proposed research as a series of specific aims is discouraged. Preliminary data are allowed but not required. Bibliographic citations (references), figures, and illustrations may be included, but must fit within the 10-page limit. The essay should include the following sections within the 10-page limit, in the following order, with the headings shown:

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

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

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

Note: Bibliographic citations are not required but if included must fit within the ten-page limit. Figures and illustrations may be included but must also fit within the 10-page limit.

7. PHS 398 Cover Letter (Optional):

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

PD/PI name; Funding Opportunity Title: 2011 NIH Director’s New Innovator Award Program (DP2); and an explanation of the reason for the late submission.

(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. Moreover, since this is an RFA, late applications will not be accepted due to service on study sections.)

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

The NIH requires the PD/PI to fill in his/her Commons User ID in the PROFILE Project Director/Principal Investigator section, Credential log-in field of the Research & Related Senior/Key Person Profile component.

Organizational DUNS

The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

PHS398 Research Plan Component Sections

Not applicable.

Budget Component

A Budget Component is not required and will not be accepted. Enter $1,500,000 for items 16, 16a, and 16b in the SF424 (R&R) Cover Component.

Appendix Materials

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

Resource Sharing Plan(s)

The following resource sharing will be requested as just-in-time information if an award is being considered:

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

Review Process

Applications that are complete and responsive to this FOA will be reviewed in two phases by a multidisciplinary scientific review group of outside experts convened by NIGMS on behalf of the Office of the Director and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below. Applications will initially be evaluated for scientific and technical merit by outside reviewers and will not provide overall impact/priority scores nor standard criterion scores. Subsequently, an editorial-style panel will consider the applications and the comments of the initial reviewers to select the most meritorious applications. These will be discussed, and the panel will determine overall impact/priority scores for them. Applications that the panel considers less meritorious will not be discussed. The Advisory Committee to the Director (ACD), NIH, will conduct the final level of review. The Director, NIH, will select awardees based on the outcomes of the scientific peer review, the recommendations of the ACD, and programmatic considerations. Final selection of awardees will be in July 2011.

Applications that are not selected for discussion in the second phase of review will receive summary statements with brief reviewer comments. These applications will be designated as Not Discussed and will not receive a numerical impact/priority score. Applications selected for discussion in the second phase of review will receive summary statements with brief reviewer comments and a numerical impact/priority score. Criterion scores will not be provided for any application.

As part of the scientific peer review, all applications will:

The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability. As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

For the New Innovator Award program, the emphasis in review will be on 1) the importance and potential impact of the scientific problems in biomedical and behavioral research, 2) the novelty and innovativeness of the approach, and 3) evidence of the applicant s potential for creative and innovative research as an early stage investigator.

Overall Impact

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria, and additional review criteria (as applicable for the project proposed).

Significance. Does the project address an important problem or a critical barrier to progress in the field? If the goals of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the goals change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Investigator. Is the PD/PI well suited to the project? As an Early Stage Investigator, does the PD/PI have appropriate experience and training? Does the PI commit to devote 25% or more of his/her research effort on the New Innovator Award project?

Innovation. Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach. Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment. Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Additional Review Criteria

As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.

Protections for Human Subjects. For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.

Inclusion of Women, Minorities, and Children. When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.

Vertebrate Animals. The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information, see http://grants.nih.gov/grants/olaw/VASchecklist.pdf.

Biohazards. Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmission Applications. Resubmissions are not allowed for this FOA.

Renewal Applications. Renewals are not allowed for this FOA.

Revision Applications. Revisions are not allowed for this FOA.

Additional Review Considerations

As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact/priority score.

Applications from Foreign Organizations. Foreign applications are not allowed for this FOA.

Select Agents Research. Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans. If an award is considered likely, plans for sharing or reasons for not sharing will be expected as Just-In-Time information for the following types of resources: 1) Data Sharing Plan (http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).

Budget and Period of Support. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Selection Process

Applications submitted in response to this FOA will compete for available funds with all other recommended applications submitted in response to this FOA. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

Applicants will be notified of their status in March 2011. Awardees will be notified in July 2011. Awards will begin in September, 2011.

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the NIH eRA Commons.

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

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Section IV.5., Funding Restrictions.

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.

3. Reporting

Awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

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.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

Section VII. Agency Contacts

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):

Ravi Basavappa, Ph.D.
National Institute of General Medical Sciences
National Institutes of Health
Building 45, Room 2As19e, MSC 6200
Bethesda, Maryland 20892-6200
301-594-0828
Email: [email protected]

2. Peer Review Contact(s):

George M. Santangelo, Ph.D.
National Institute of General Medical Sciences
National Institutes of Health
Building 45, Room 2As55, MSC 6200
Bethesda, Maryland 20892-6200
Phone: 301-594-4469
Email: [email protected] (e-mail is the strongly preferred method for inquiries)

3. Financial/Grants Management Contact(s):

Nicole A. Fleisher
Grants Management Officer
National Institute of General Medical Sciences
National Institutes of Health
Building 45, MSC 6200
Bethesda, Maryland 20892-6200
Phone: 301-594-3923
FAX: 301-480-2554
Email: [email protected]

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:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing). Investigators should seek guidance from their institutions, on issues related to institutional policies and local institutional review board (IRB) rules, as well as local, State and Federal laws and regulations, including the Privacy Rule.

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/

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

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-09-116.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.

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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