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://nihroadmap.nih.gov. All NIH Institutes and Centers are participating. This FOA is being administered by the National Institute of General Medical Sciences (NIGMS) on behalf of NIH.

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

Announcement Type

New

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

Program Announcement (PA) Number: PAR-09-012

NOTICE: Pre-applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide. 

PRE-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 submitting individuals are highly encouraged to start the process at least four (4) weeks prior to the grant submission date. See Section IV.

Catalog of Federal Domestic Assistance Number(s)
93.310

Key Dates
Release/Posted Date: October 23, 2008
Opening Date:  November 17, 2008 (Earliest date a pre-application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): Not applicable
NOTE: On-time submission requires that pre-applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the submitting individual’s institution/organization). 
Pre-application Due Date(s): December 17, 2008
Peer Review Date(s): March 2009
Council Review Date(s): Not applicable
Earliest Anticipated Start Date(s): Not applicable
Additional Information To Be Available October 17, 2008: Frequently Asked Questions will be posted at http://nihroadmap.nih.gov/clinicalresearch/overview-dynamicoutcomes.aspdExpiration Date: December 18, 2008

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 and Information

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

Section VI. Award Administration Information
1. Award Notices

2. Administrative and National Policy Requirements
3. Reporting

Section VII. Agency Contacts
1. Scientific/Research Contact(s)

2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

The NIH Director’s Pioneer Award Program is a unique aspect of the NIH Roadmap for Medical Research (http://nihroadmap.nih.gov). Pioneer Awards are designed to support individual scientists of exceptional creativity who propose pioneering – and possibly transformative – approaches to major challenges in biomedical and behavioral research. The term “pioneering” is used to describe highly innovative approaches that have the potential to produce an unusually high impact on a broad area of biomedical or behavioral research, and the term “award” is used to mean a grant for conducting research, rather than a reward for past achievements. To be considered pioneering, the proposed research must reflect ideas substantially different from those already being pursued in the investigator’s laboratory or elsewhere. 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 proposed research may be in any scientific area relevant to the mission of NIH but need not be in a conventional biomedical or behavioral discipline.  If the individual’s experience is in non-biological areas, however, he/she must demonstrate a commitment to exploring topics of biomedical or behavioral relevance.

This announcement utilizes the X02 mechanism for submission of pre-applications.  Pre-applications are a necessary first step in applying for a 2009 Pioneer Award. Pre-applications will be evaluated by a group of external reviewers.  Those investigators whose projects are judged to be the most outstanding will be notified of the opportunity to submit full (DP1) applications under RFA-RM-09-001. 

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

Section II. Award Information


1. Mechanism of Support

This announcement utilizes the X02 mechanism for submission of pre-applications.  Pre-applications are a necessary first step in applying for a 2009 Pioneer Award. Pre-applications will be evaluated by a group of external reviewers.  Those investigators whose projects are judged to be the most outstanding will be notified of the opportunity to submit full (DP1) applications under RFA-RM-09-001.  The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.

2. Funds Available

All awards will be made under RFA-RM-09-001.  No awards will be made under this FOA.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

Foreign institutes are not eligible to apply in response to this FOA.

1.B. Eligible Individuals

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her organization to develop and submit a pre-application.  Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. Only one PD/PI (i.e., no multiple PDs/PIs) may be designated on the pre-application. Investigators at all career levels who meet the eligibility criteria and are currently engaged in research are eligible to submit pre-applications.  Those at early to middle stages of their careers, and women and members of groups underrepresented in biomedical or behavioral research are especially encouraged to apply.

This initiative is to support investigators who intend to pursue new research directions – research that is distinct from that currently or previously conducted by the investigator.  Pre-applications for projects that are extensions of ongoing research should not be submitted. Pioneer awardees are required to commit the major portion (at least 51%) of their research effort to activities supported by the Pioneer Award program. Those who will not be able to meet this requirement should not submit pre-applications. Investigators who were not selected for an award in prior years may submit pre-applications this year; however, all applications must be submitted as “new” applications regardless of any previous submission to the program.

Those at early to middle stages of their careers, and women and members of groups underrepresented in biomedical or behavioral research are especially encouraged to apply.

Only one PD/PI (i.e., no multiple PDs/PIs) may be designated on the application. NIH intramural investigators are not eligible for support under this program.

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

Resubmissions of pre-applications are not allowed.

Pre-applications to renew a DP1 award are not allowed.

An individual may not submit more than one pre-application. There is no limit to the number of pre-applications institutions may submit. All pre-applications will be considered “new”, regardless of any previous applications to the Pioneer Award Program.

Section IV. Application and Submission Information


To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, use the “Apply for Grant Electronically” button in this FOA or link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site. See the detailed instructions below regarding choosing a pre-application package (Section IV.2 – Content and Form of Application 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 a submitting individual can submit an electronic pre-application, as follows:  

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

2) Organizational/Institutional Registration in the eRA Commons

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

Both the PD/PI and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the pre-application image.

Note that for this FOA, only one PD/PI will be allowed (i.e., no multiple PD/PIs).

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, submitting individuals 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 pre-applications only from organizations that have completed all necessary registrations.

1. Request Application Information

Submitting individuals must download the SF424 (R&R) application forms and the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply. After clicking “Apply for Grant Electronically,” individuals will be presented with a list of ten pre-application packages corresponding to ten scientific areas, as described in the Special Instructions in Section 2 below.

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

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

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

2. Content and Form of Application Submission

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

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

The SF424 (R&R) pre-application has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed pre-application in response to this FOA includes the data in the following components:

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

Optional Components:

PHS398 Cover Letter File
Note: Cover letters should be submitted only when submitting a Changed/Corrected Pre-application after the submission date, and should include an explanation for the late submission.

SPECIAL INSTRUCTIONS  

Pre-applications with Multiple PDs/PIs are not allowed.

ADDITIONAL PRE-APPLICATION INSTRUCTIONS

The following instructions are specific to the Pioneer Award X02 pre-applications and are exceptions to the general SF424 instructions.  Pre-applications that do not conform to the specific instructions detailed below will not be reviewed. There are significant changes to the instructions from previous years, so please review all instructions carefully. Note:  Letters of reference are not required and will not be accepted for pre-applications.  Reference letters will be required for those applicants submitting full (DP1) applications to RFA-RM-09-001.

All of the following must be submitted for the pre-application to be considered complete:

I)      Area of Science Designation:  Individuals must designate one of the following ten areas of science for their pre-application:

01  Behavioral and Social Sciences
02   Chemical Biology

03  Clinical and Translational Research
04  Epidemiology
05  Immunology
06  Instrumentation and Engineering
07  Molecular and Cellular Biology
08  Neuroscience
09  Physiology and Integrative Systems
10  Quantitative and Computational Biology

The areas of science are used by NIH staff to ensure that applications are assigned to the most appropriate peer reviewers. All ten scientific areas are considered as a single competition, and are reviewed by the same process and in the same time period.

To designate a science area:

1.  Download and submit the pre-application with the Grants.gov pre-application package for the chosen science area. There are 10 separate pre-application packages (Competition IDs) in Grants.gov for this Funding Opportunity Announcement (FOA), one for each of the above areas of science.  The only difference between the packages is the indicated area of science.  Download the application package that is the most appropriate for your research project.  Individuals may download and submit only one of the ten pre-application packages. 

2.  Include the area of science (two-digit code and title of the science area) at the top of the abstract page. The area of science will not be included in the 300-character limit.

3.  Verify that the pre-application has been submitted to the appropriate science area.  The science area will be listed in the Competition ID field on the first page of their pre-application (the transmittal sheet) in the Commons.  If the pre-application has been submitted to the wrong science area, individuals must notify program staff immediately by email to pioneer@nih.gov.

II.  Abstract:  An abstract of no more than 300 words (and not exceeding one page) describing the goals of the project.  The area of science should be listed at the top of the abstract page and does not count toward the 300 word limit. The abstract must contain text only – no figures, animations, or web links to provide further information.  The abstract should be uploaded as an attachment for item 6, Project Summary/Abstract, on the Other Project Information component of the pre-application.

III.      Public Health Relevance Statement: A brief statement written in plain language about how the proposed research can positively impact public health. This statement should be uploaded for item 7, Project Narrative, on the Other Project Information component of the pre-application.

IV.   Essay:  An essay of 3-5 pages that addresses the investigator's innovative vision for, and the significance of, the biomedical or behavioral problem to be addressed, and the investigator’s qualifications to engage in groundbreaking research. The essay should describe the investigator’s view of the major challenges in biomedical or behavioral research to which he/she can make seminal contributions. The scientific plan should be provided in broad terms because the research plan is expected to evolve during the tenure of the grant. The essay should include the following in the order given with the headings as shown:

1.    Project Description:  What is the scientific problem that will be addressed, and why is this important? What are the pioneering, and possibly high-risk, approaches that, if successful, might lead to groundbreaking or paradigm-shifting results?

2.    Evidence of Innovativeness:  What concrete evidence can you provide for your claim of innovativeness? For example, qualities common to many highly innovative people include an interest in, and the ability to integrate, diverse sources of information; an inclination to challenge paradigms and take intellectual risks; persistence in the face of failure; an ability to attract the right collaborators; and the energy and concentration necessary to plan and execute effective strategies for accomplishing goals.

3.    How the Planned Research Differs From My Past or Current Work: Describe how the project represents a new and distinct direction for your research.

4.     Suitability for Pioneer Award Program: Why is the planned research uniquely suited to the stated goal of the Pioneer Award program, rather than a traditional grant mechanism?

Literature references are not required but if included must fit within the five-page limit.  Figures and illustrations may be included but must also fit within the five-page limit.  Do not include links to websites to provide further information. No animations (movies) are allowed in any documents. The essay is uploaded as an attachment in the Research Design and Methods section of the Research Plan Component. Omit the Specific Aims, Background and Significance, and Preliminary Studies Sections.

VI.    Summary of the Investigator’s Most Significant Research Accomplishment. This is limited to one page. Publications or similar documents will not be accepted. This should be uploaded using item 11, Other Attachments, on the Other Project Information Component of the pre-application.

VII.    Biographical Sketch:  A two-page biographical sketch for the PD/PI only. (Use the sample format shown in the URL in Section 4.5.2 of the Application Guide, omitting Section C, Research Support)   Only the Biographical Sketch of the submitting individual should be submitted.  No other persons should be designated as key personnel and no other biographical sketches should be uploaded. The Biographical Sketch is uploaded on the Research & Related Senior/Key Person Component form.

VIII.    List of Current and Pending Research Support:  A list of current and pending research support from all sources, including current year direct costs and percent effort devoted to each project. (Use the format shown in Section 3.1.1.8 of the Application Guide.) An effort commitment statement (described below) must be included in this document. A brief statement of the facilities to be used for the conduct of the research must also be included in this document. This document is uploaded on the Research & Related Senior/Key Person Component form.

IX.    Effort Commitment: Awardees are required to commit at least 51% of their research effort to the project supported by the Pioneer Award. A statement must be included in the list of current and pending support that if chosen to receive an award, the investigator will commit a minimum of 51% of research effort to the project supported by the Pioneer Award.

Special requirements for completing the SF424 (R&R) pre-application are specified below. In addition:

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

All instructions outlined in the SF 424 (R&R) Application Guide
(http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_Ver2.pdf) are to be followed, incorporating “Just-in-Time” information concepts, with the following exceptions, which are specific requirements for Pioneer Award pre-applications. Pre-applications that do not conform to the specific instructions detailed below will not be reviewed.

1. SF424 (R&R) COVER COMPONENT

Item Number and Title

Instructions

1.  Type of Submission

Must be “Pre-Application”

8. Type of Application

Must be “New”

13. Proposed Project

Enter start date: 09/30/2009; Enter end date: 07/31/2014

Estimated Project Funding
Funding

Enter $0

   

2.  RESEARCH & RELATED PROJECT/PERFORMANCE SITE LOCATIONS

Complete as appropriate.

 3.    RESEARCH & RELATED OTHER PROJECT INFORMATION COMPONENT:

Item Number and Title

Instructions

1. Are Human Subjects Involved?

Check ““No.” Detailed plans regarding protection of human subjects, inclusion of women and minorities, targeted/planned enrollment, and inclusion of children are not required and should not be submitted with this pre-application.  This information will be required from only those individuals who submit full applications in response to RFA RM-09-001.

2. Are Vertebrate Animals Used?

F Check “No.” Detailed information regarding the use of vertebrate animals is not required at the time of submission. This information will be required only from those individuals who are notified to submit full applications in response to RFA RM-09-001,

6. Project Summary/Abstract

Attach abstract. (Maximum of 300 words [not to exceed one page]; (PDF format; text only – no figures, animations, or web links)

7. Project Narrative

Attach Public Health Relevancy Statement (2 – 3 sentence) statement explaining public health relevance (PDF format)

8. Bibliography & References Cited

Do not use. If you choose to include figures or reference citations, they must be included in the essay, subject to the 5-page limit.

9. Facilities & Other Resources

Do not use.

10. Equipment

Do not use.

11. Other Attachments

Attach 1 page description of your most significant research accomplishment. (PDF format)

Note: Pre-applications found not to comply with the page limit requirements or that contain attachments other than those specified will not be reviewed.

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

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

Item Title

Instructions

Profile- PD/PI – Attach Biographical Sketch

Attach biographical sketch here (two-page maximum, PDF format). Use the form shown in the URL in Section 4.5.2 of the Application Guide, omitting Section C, Research Support (see below).

Profile- PD/PI – Attach Current & Pending Support

Attach a list of Current and Pending Support here (PDF format). Use the form shown in Section 3.1.1.8 of the Application Guide. Be sure to include statement affirming that you will devote at least 51% of research effort to the Pioneer Award project. Also, include a brief statement of the facilities to be used for the conduct of the research.

Profile – Senior Key Person 1

Do not use.  Submit information only for PD/PI.  Information on collaborators may be included in the essay.

Note: Pre-applications found not to comply with the page limit requirements will be rejected during the agency validation process.

4. PHS398 COVER PAGE SUPPLEMENT

Item Title

Instructions

2. Human Subjects

Omit.

4. Human Embryonic Stem Cells

Omit.

5. PHS398 Research Plan Component Sections

Item Number and Title

Instructions

1. Introduction to Application (for Resubmission or Revision only)

Omit

2. Specific Aims

Omit

3. Background and Significance

Omit

4. Preliminary Studies/Progress Report

Omit

5. Research Design and Methods

Attach 3 – 5 page essay (PDF format). Include area of science (e.g., (01 – Behavioral and Social Sciences) and project title on first page of essay. Literature references are not required but if included must fit within the five-page limit.  Figures and illustrations may be included but must also fit within the five-page limit. Do not include links to websites for further information. Do not include animations.

6. PHS 398 Cover Letter File (Optional):

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

1.   PD/PI name.

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

3. For Changed/Corrected Pre-applications submitted after the submission deadline, include an explanation of the reason for the Changed/Corrected Pre-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 Pioneer Award pre-applications.)

Appendix Materials 

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

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review and Anticipated Start Dates
Opening Date:  November 17, 2008 (Earliest date an pre-application may be submitted to Grants.gov)
Pre-application Due Date(s): December 17, 2008
Peer Review Date(s): March 2009
Council Review Date(s): Not applicable  
Earliest Anticipated Start Date(s): Not applicable

3.A.1. Letter of Intent

A letter of intent is not required for this announcement.

3.B. Submitting an Application Electronically to the NIH

To submit a pre-application in response to this FOA, individuals should access this FOA via http://www.grants.gov/applicants/apply_for_grants.jsp and follow Steps 1-4. Note:  Pre-applications must only be submitted electronically.  PAPER PRE-APPLICATIONS WILL NOT BE ACCEPTED. 

3.C. Application Processing

Pre-applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the individual’s institution/organization) on the pre-application due date(s). (See Section IV.3.A. for all dates.) If a pre-application is not submitted by the due date(s) and time, the pre-application may be delayed in the review process or not reviewed.

Once an pre-application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled pre-application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two weekdays (Monday – Friday, excluding Federal holidays) to view the pre-application image to determine if any further action is necessary.

Upon receipt, pre-applications will be evaluated for completeness by the Center for Scientific Review, NIH. Incomplete pre-applications will not be reviewed.

There will be an acknowledgement of receipt of pre-applications from Grants.gov and the Commons. The submitting AOR/SO receives the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons acknowledgments. Information related to the assignment of a pre-application to a Scientific Review Group is also in the Commons. 

Note: Since email can be unreliable, it is the responsibility of the submitting individual to periodically check the status of the pre-application in the Commons.

The NIH will not accept any pre-application in response to this FOA that is essentially the same as an application currently pending initial review, unless the investigator withdraws the pending application. When a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the FOA must not include an “Introduction” describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

Not applicable

6. Other Submission Requirements and Information.

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

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

Organizational DUNS

The 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.”

Appendix Materials 

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

Resource Sharing Plan(s)

The following resource sharing policies do not apply to this FOA:

Section V. Application Review Information


1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).  

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

2. Review and Selection Process

Pre-applications that are complete and responsive will be evaluated by a group of external reviewers which will include eminent scientists with expertise in the ten science areas designated in the “Additional Pre-Application Instructions” section above.  Those investigators whose submissions are judged to be the most outstanding will be notified of the opportunity to submit a full (DP1) application under RFA-RM-09-001. Given the nature of the review, no summary statement or other written critique will be provided to submitting individual.

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health.

Pre-applications will be evaluated based on the likelihood that the submitting individual will pursue a pioneering approach to a problem of relevance to biomedical or behavioral research, the absence of alternative funding to pursue this direction, and compelling justification for the advantage of evaluation by the Pioneer Award process. In particular, reviewers will evaluate:

2.A. Additional Review Criteria

None.

2.B. Additional Review Considerations

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

2.C. Resource Sharing Plan(s)

The following resource sharing policies do not apply to this FOA:

3. Anticipated Announcement and Award Dates

 Those investigators whose projects are judged to be the most outstanding will be notified in April, 2009, of the opportunity to submit full (DP1) applications under RFA-RM-09-001.  No awards will be made under this FOA.  Awards will be made under PAR-RM-09-001.  Awards under PAR-RM-09-001 will be announced in September, 2009, and will begin September 30, 2009.

Section VI. Award Administration Information


1. Award Notices

Not applicable.

2. Administrative and National Policy Requirements

Not applicable

3. Reporting

Not applicable

Section VII. Agency Contacts


We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential submitting individuals. 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
Phone: 301-594-0828
Email:  pioneer@nih.gov  (e-mail is the strongly preferred method for inquiries)

2. Peer Review 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
Phone: 301-594-0828
Email:  pioneer@nih.gov  (e-mail is the strongly preferred method for inquiries)

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).

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 submitting individuals to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Submitting individuals 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, submitting individuals should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research” (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the SF424 (R&R) application; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for Federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility of the submitting individual to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy, investigators funded by the NIH must submit or have submitted for them to the National Library of Medicine’s PubMed Central (see http://www.pubmedcentral.nih.gov/), an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication. The NIH Public Access Policy is available at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html). For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (HHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the HHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, Internet addresses (URLs) or PubMed Central (PMC) submission identification numbers must be used for publicly accessible on-line journal articles. Publicly accessible on-line journal articles or PMC articles/manuscripts accepted for publication that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference in either the Bibliography & References Cited section, the Progress Report Publication List section, or the Biographical Sketch section of the NIH grant application. A URL or PMC submission identification number citation may be repeated in each of these sections as appropriate. There is no limit to the number of URLs or PMC submission identification numbers that can be cited.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential submitting individuals 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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