and Human Services (HHS)
EXPIRED
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 the NIH.
Title: 2008 NIH Director's Pioneer Award Program (DP1)
Announcement Type
This is a reissue of RFA-RM-06-005, which was previously released November 18, 2005.
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.
Update: The following update relating to this announcement has been issued:
APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.
This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).
A registration process is necessary before submission and applicants are highly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.
Request For Applications (RFA) Number: RFA-RM-08-013
Catalog of Federal Domestic Assistance Number(s)
93.310
Key Dates
Release/Posted Date: November 1, 2007
Opening Date: December 16, 2007 (Earliest date an application may be
submitted to Grants.gov)
Letters of Intent Receipt Date(s): Not applicable.
NOTE: On time submission requires that applications be successfully submitted
to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization).
Application Submission/Receipt Date: January
16, 2008
Reference Letter Submission/Receipt Dates: December 18, 2007 5:00 p.m. (EST) January 16, 2008
Peer Review Date(s): April 2008
Advisory Council to the Director Review Date: August
2008
Earliest Anticipated Start Date: September 30, 2008
Additional Information to Be Available Date (Activation
Date): October 24, 2007 - Frequently Asked Questions (FAQs) at http://nihroadmap.nih.gov/pioneer/faq.aspx
Expiration Date: January 17,
2008
Due Dates for E.O. 12372
Not Applicable
Additional Overview Content
Executive Summary
The NIH Director’s Pioneer Award Program is meant to complement NIH's traditional, investigator-initiated grant programs by supporting individual scientists of exceptional creativity who propose pioneering and possibly transformative approaches to major contemporary challenges that have the potential to produce a major impact in a broad area of biomedical or behavioral research. To be considered pioneering, the proposed research must reflect ideas substantially different from those already being pursued in the investigator’s laboratory or elsewhere.
Table of Contents
Part I Overview Information
Part II Full Text of Announcement
Section I. Funding Opportunity
Description
1. Research Objectives
Section II. Award Information
1. Mechanism of Support
2. Funds Available
Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing or Matching
3. Other - Special Eligibility Criteria
Section IV. Application and
Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission, Review, and Anticipated
Start Dates
1.
Letter of Intent
B. Submitting an Application
Electronically to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section V. Application Review
Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates
Section VI. Award Administration
Information
1. Award Notices
2. Administrative and National Policy Requirements
A. Cooperative Agreement Terms and Conditions of Award
3. Reporting
Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)
Section VIII. Other Information
- Required Federal Citations
Part II - Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
The NIH Director’s Pioneer Award Program is a unique aspect of the NIH Roadmap for Medical Research (http://nihroadmap.nih.gov) and is a High-Risk Research initiative of Research Teams of the Future. 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.
Background
The NIH's success depends on the creativity of investigator-initiated research, much of it supported by the R01 grant mechanism. Many scientists who participated in the development of the NIH Roadmap, however, expressed the view that additional means might be necessary to identify scientists with ideas that have the potential for high impact but may be too novel, span too diverse a range of disciplines, or be at a stage too early to fare well in the traditional peer review process. A group of distinguished outside consultants proposed that NIH implement a completely new program to encourage highly innovative biomedical research with the great potential to lead to significant advances in human health. This program would complement NIH's traditional, investigator-initiated grant programs. Pioneer Awards are designed to support highly creative and pioneering people who propose exceptionally innovative approaches with the potential for high impact on a significant biomedical or behavioral research problem.
First announced in Fiscal Year 2004, nine awards were made in September 2004, 13 awards each were made in 2005 and 2006, and 12 awards were made in 2007.
This FOA announces a fifth Pioneer Award competition for approximately 5 -10 new awards of $500,000 in direct costs per year for five years that will be made in Fiscal Year 2008. Awardees must commit the major portion (at least 51%) of their research effort to activities supported by the Pioneer Award. Individuals who are unable to meet this requirement should not apply.
This FOA uses Just-in-Time information concepts. For this FOA only, information regarding protection of human subjects, inclusion of women, minorities and children in research, animal care and use, biohazard protection, and sharing of model organisms should not be submitted with this application. The required information will be requested just-in-time if an award is being considered.
1. Mechanism of Support
This Funding Opportunity Announcement (FOA) will use the DP1 award mechanism. The applicant will be solely responsible for planning, directing, and executing the proposed project. Applications proposing multiple PIs are not allowed.
2. Funds Available
This is a Roadmap initiative. The NIH Common
Fund has set aside sufficient
funds in FY2008 to provide at
least 5-10 awards,
contingent upon the availability of funds and the submission of a sufficient
number of meritorious applications.
Awards will be for $500,000 in direct costs each year for five years, plus applicable Facilities and Administrative costs to be determined at the time of award.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
For this FOA, Facilities
and Administrative (F&A) costs requested by consortium participants must
be included in the total direct costs requested. The F&A costs for the primary
grantee institution will be added at the time of award, and will be based on the grantee institution’s current negotiated
rate.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
You may submit an application(s) if your institution/organization is a domestic institution that has any of the following characteristics:
Non-domestic (non-U.S.) entities (Foreign Organizations) are not eligible to apply.
1.B. Eligible Individuals
Investigators at all career levels who meet the eligibility criteria and are currently engaged in research are eligible to apply. The research proposed need not be in a conventional biomedical or behavioral discipline; if the applicant s experience is in non-biological areas, however, he/she must demonstrate a commitment to exploring topics of biomedical or behavioral relevance. If selected for an award, applicants must show evidence of institutional infrastructure support.
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. Applications for projects that are extensions of
ongoing research should not be submitted and will not be funded. Awardees are required to commit the major portion (at
least 51%) of their research effort to activities supported by the Pioneer
Award program. Applicants who were not selected for an award in prior
years may submit applications this year. Investigators at all career
levels are eligible.
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.
There are no citizenship or residency requirements.
2. Cost Sharing or Matching
This program does not require cost sharing as defined in the current NIH
Grants Policy Statement.
3. Other-Special Eligibility Criteria
Applicants may submit only one application
as a PD/PI in response to this FOA. There is no limit to the number of applications
that institutions may submit. All applications will be considered new applications,
regardless of any previous applications to the Pioneer Award Program. Competing
renewal (formerly competing continuation ) applications will not be accepted.
Section IV. Application and Submission Information
To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site. See the detailed instructions below regarding choosing an application package (Section 1 Request Application Information).
A one-time registration is required for institutions/organizations at both:
PDs/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.
Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:
1) Organizational/Institutional Registration in Grants.gov/Get Started
2) Organizational/Institutional Registration in the eRA Commons
3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.
Both the PD/PI and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.
Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.
Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.
1. Request
Application Information
Applicants must download the SF424 (R&R) application
forms and SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply. After clicking Apply for Grant Electronically, applicants
will be presented with a list of ten application packages corresponding
to ten scientific areas, as
described in the Special Instructions in Section 2 below. (The selection of scientific area by applicants is solely
to aid in selection of the most appropriate group of peer reviewers. The
application requirements and instructions below are
identical for all ten packages. All ten
scientific areas are considered as a single competition, are reviewed in
the same time period, and compete for a single source of funds.)
Note: Only the forms package
directly attached to a specific FOA can be used. You will not be able
to use any other SF424 (R&R) forms (e.g., sample forms, forms from
another FOA), although some of the "Attachment" files may be
useable for more than one FOA.
For further assistance, contact GrantsInfo: Telephone
301-710-0267, Email: [email protected].
Telecommunications for the hearing impaired: TTY
301-451-5936.
2. Content and Form of Application Submission
Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide for this FOA through Grants.gov/APPLY.
The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by NIH (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include the following components:
Required Components:
SF424 (R&R) (Cover component)
Research & Related Other Project Information
Research & Related Senior/Key Person
Optional Components:
When submitting a Changed/Corrected Application after
the submission date, a cover letter is required explaining the reason for
the Changed/Corrected Application. If you already submitted a cover letter
with a previous submission and are now submitting a Changed/Corrected Application,
you must include all previous cover letter text in the revised cover letter
attachment. The system does not retain any previously submitted cover letters
therefore, you must repeat all information previously submitted in the cover
letter as well as any additional information. Cover letters are not required
when submitting changed/corrected applications before the receipt deadline.
SPECIAL INSTRUCTIONS
The NIH requires the PD/PI to fill in his/her Commons User ID in the PROFILE Project Director/Principal Investigator section, Credential log-in field of the Research & Related Senior/Key Person Profile component. The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Registration FAQs Important Tips -- Electronic Submission of Grant Applications.
The Commons ID of the PD/PI must be included in the Credential field of the Research & Related Senior/Key Person component. Failure to include this data field will cause the application to be rejected.
Applications proposing multiple PIs are not allowed.
The application to be submitted to Grants.gov must include:
Download the application package that best describes your area of proposed research. You may download and submit only one of the ten application packages.
The application requirements and instructions are identical for all ten packages and are described further in the sections that follow. The only difference between the packages is the indicated category of scientific research. 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. All ten scientific areas are considered as a single competition, are reviewed in the same time period, and compete for a single source of funds.
Areas of Science:
01 Behavioral and Social Sciences
02 Chemical Biology
03 Clinical and Translational Research
04 Epidemiology
05 Immunology
06 Instrumentation and Engineering
07 Molecular and Cellular Biology
08 Neuroscience
09 Physiology and Integrative Systems
10 Quantitative and Computational Biology
Special requirements for completing the SF424 (R&R) application are specified in Section IV.6, 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)
3. Submission Dates and Times
See Section IV.3.A for
details.
3.A. Submission, Review, and Anticipated Start Dates
Opening Date: December 16, 2007 (Earliest
date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): Not
applicable
Application Submission/Receipt Date: January
16, 2008
Reference Letter Submission Dates: December
18, 2007 January 16, 2008
Peer Review Date(s): April 2008
Advisory Council to the Director Review Date(s): August
2008
Earliest Anticipated Start Date: September
30, 2008
3.A.1. Letter of Intent
A letter of intent is not required for the funding opportunity and will not be accepted.
3.B.
Submitting an Application Electronically to the NIH
To submit an application in response to this FOA, applicants should access
this FOA via http://www.grants.gov/Apply and
follow steps 1-4. Also see Special Instructions in Section IV.2 of this
FOA. Note: Applications must only be submitted electronically.
PAPER APPLICATIONS WILL NOT BE ACCEPTED.
3.C. Application Processing
Applications may be submitted on or after
the opening date and must be successfully received by Grants.gov
no later than 5:00 p.m. local time (of the
applicant institution/organization) on the
application submission/receipt date. (See Section
IV.3.A. for all dates.) If an application is not submitted by
the receipt date and time, the application may be delayed in the review
process or not reviewed.
Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two business days to view the application image.
Upon receipt, applications will
be evaluated for completeness by NIH staff. Incomplete applications will
not be reviewed.
There will be an acknowledgement of receipt
of applications from Grants.gov and the Commons. Information
related to the assignment of an application to a Scientific Review Group
is also in the Commons.
Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on his/her application status in the Commons.
4. Intergovernmental
Review
This initiative is not subject to intergovernmental
review.
5. Funding Restrictions
All NIH awards are subject to the terms and conditions,
cost principles, and other considerations described in the NIH Grants
Policy Statement.
6. Other Submission Requirements
PD/PI Credential (e.g., Agency Login)
The NIH requires the PD/PI to fill in his/her Commons User ID in the PROFILE Project Director/Principal Investigator section, Credential log-in field of the Research & Related Senior/Key Person Profile component.
Organizational DUNS
The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
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 following exceptions, which are specific requirements for Pioneer Award applications. Applications that do not conform to the specific instructions detailed below will not be reviewed.
1. SF424 (R&R) COVER COMPONENT
Item Number and Title |
Instructions |
8. Type of Application |
Must be New |
13. Proposed Project |
Enter start date: 09/30/2008; Enter end date: 07/31/2013 |
16 Estimated Project Funding |
Enter $2,500,000 |
16 b. Total Federal & Non-Federal Funds |
Enter $2,500,000 |
2. RESEARCH & RELATED OTHER PROJECT INFORMATION COMPONENT:
Item Number and Title |
Instructions |
1. Are Human Subjects Involved? |
Follow the Application Guide instructions for all fields in Section 1.a. Check Yes or No as appropriate. If Yes , enter None, or the IRB Approval Date, Exemption Number, and Human Subject Assurance Numbers may be entered but are not required at the time of submission. Detailed plans regarding protection of human subjects, inclusion of women and minorities, targeted/planned enrollment, and inclusion of children are not required at the time of submission. This information will be requested on a just-in-time basis at the time of award. |
2. Are Vertebrate Animals Used? |
Follow the Application Guide instructions for all fields in 2.a. Check Yes or No as appropriate. Enter None. Detailed plans regarding the use of vertebrate animals are not required at the time of submission. The IACUC Approval Date and Animal Welfare Assurance Numbers may be entered but are not required at the time of submission. This information will be requested on a just-in-time basis at the time of award. |
6. Project Summary/Abstract |
Attach abstract. (Maximum of 300 words [not to exceed one page]; PDF format) |
7. Project Narrative |
Attach essay (Maximum of 5 pages; PDF format) |
8. Bibliography & References Cited |
Do not use. If you choose to include figures or reference citations, they must be included in the essay, subject to the 5-page limit. |
9. Facilities & Other Resources |
Do not use. |
10. Equipment |
Do not use. |
11. Other Attachments |
Attach description of your most significant research accomplishment (one page maximum; PDF format.) |
Note: Applications found not to comply with the page limit requirements or that contain attachments other than those specified will be rejected during the agency validation process.
3. SF424 (R & R) SENIOR/KEY PERSON PROFILE COMPONENT:
Complete items only for Project Director/Principal Investigator. Do not submit profiles for other senior/key personnel.
Item Title |
Instructions |
Profile- PD/PI - Attach Biographical Sketch |
Attach biographical sketch here (two-page maximum, PDF format). Use the form shown in the URL in Section 4.5.2 of the Application Guide, omitting Section C, Research Support (see below). |
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 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: Applications found not to comply with the page limit requirements will be rejected during the agency validation process.
4. PHS 398 Cover Letter File (Optional):
Cover letters should be included only when submitting 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:
1. PD/PI name.
2. Funding Opportunity Title: 2008 NIH Director’s Pioneer Award Program (DP2).
3. For Changed/Corrected Applications submitted after the submission deadline, include an explanation of the reason for the Changed/Corrected Application.
(See full instructions for submitting the Cover Letter Component in Section 5.2 of the Application Guide. Note: Items 3 6 of the Guide do not apply to Pioneer Award applications.)
Letters of Reference:
Letters of reference are an important component of the Pioneer Award application. Applicants must arrange to have three (and no more than three) letters of reference submitted on their behalf. Applications that are missing letters of reference may be considered non-responsive and may not be reviewed. Late letters will not be accepted. Applicants are responsible for monitoring the submission of their letters to ensure that three letters have been submitted prior to the submission deadline. Applicants can check the status of their letters in their Commons accounts.
Letters may be submitted beginning December 18, 2007, and must be submitted no later than 5:00 p.m. (EST) January 16, 2008.
Applicants must provide the following to their referees (Note: referees will not be able to submit letters without this information):
Applicants are encouraged to forward the instructions below to their referees or to direct their referees to the following web page that includes the instructions (http://nihroadmap.nih.gov/pioneer/LettersofReferenceFormat.aspx).
Confirmations will be sent by email to both the applicant and the referee. The confirmation sent to the applicant will include the referee’s name and the date and time the letter was submitted. The confirmation sent to the referee will include the referee and applicant’s names, a confirmation number, and the date and time the letter was submitted.
Letters of reference are confidential. Applicants will not have access to the letters.
Note: Since email can be unreliable, it is the applicant s responsibility to check the status of his/her letters of reference periodically in the Commons.
Applicants are encouraged to send the following instructions to their referees:
Instructions for Referees:
Letters may be submitted to the Commons at (URL) beginning December 18, 2007, and must be submitted no later than 5:00 p.m. (EST), January 16, 2008. Late letters will not be accepted and applications with fewer than three letters may not be reviewed. Letters must be submitted electronically paper copies will not be accepted.
The applicant’s name should be placed at the top of the letter. Although signatures are not required, the letter must include a signature block with the referee’s full name, title, institution, and contact information.
In two pages or less, describe the applicant’s qualities that support his/her claim to scientific innovativeness and creativity. When possible, give specific examples that illustrate these qualities. Address the likelihood that the applicant will conduct groundbreaking research in the proposed research area.
Letters may be submitted from December 18, 2007 to 5:00 p.m. (EST) January 16, 2008 at (https://public.era.nih.gov/commons/public/reference/submitReferenceLetter.do?mode=new)
The following information is required and must be entered on the letter submission page at the time of submission:
Note: The letter submission page can be accessed without signing into the Commons, and referees do not have to be registered in the Commons. Referees must provide the applicant s Commons User Name and the other information detailed in this section.
Email confirmations will be sent to both the applicant and the referee following submission of the letter. The email confirmation will include a Confirmation Number that will be required when resubmitting letters. Please print the confirmation email for your records.
Note: If you submitted letters for Pioneer Award applicants in a prior year, you must submit new letters of reference this year. Previously submitted letters will not be retrieved.
Please see the detailed instructions on submitting letters of reference at http://nihroadmap.nih.gov/pioneer/LettersofReferenceFormat.aspx and the Frequently Asked Questions at http://nihroadmap.nih.gov/pioneer/faq.aspx. Send question to [email protected].
PHS398 Research Plan Component Sections:
Not applicable.
Appendix Materials:
Appendices are not allowed and will not be accepted. Applications that contain attachments other than those specified may be rejected during the agency validation process.
Plan for Sharing Research
Data
Not applicable.
Sharing Research Resources
Not applicable.
Section V. Application Review Information
1. Criteria
Only the review criteria described below will be considered in the review process.
2. Review and Selection Process
Applications will be evaluated based on the
likelihood that the applicant 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
rather than by the standard peer review process. In particular, reviewers will
evaluate:
The following will be considered in making funding decisions:
Applications that are complete and responsive to the FOA will be evaluated electronically by a multidisciplinary group of outside experts. Those candidates who are identified as the most outstanding will be invited to NIH for interviews in July 2008. Interviews will be conducted by a panel of distinguished outside experts. The Advisory Committee to the Director (ACD), NIH, will conduct the final level of review. The Director, NIH, will make the final selection of awardees based on the evaluations by the outside experts, the recommendations of the ACD, and programmatic considerations. Final selections will be publicly announced, and awards made, by the end of September 2008.
2.A. Additional Review Criteria:
NOTE: For this FOA only, information regarding protection of human subjects, inclusion of women, minorities and children in research, animal care and use, biohazard protection, and sharing of model organisms should not be submitted with this application. The required information will be requested just-in-time if an award is being considered.
Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. See the Human Subjects Sections of the PHS398 Research Plan component of the SF424 (R&R).
Inclusion of Women, Minorities
and Children in Research: The adequacy of plans to include subjects
from both genders, all racial and ethnic groups (and subgroups), and
children as appropriate for the scientific goals of the research will
be assessed. Plans for the recruitment and retention of subjects will
also be evaluated. See the Human Subjects Sections of the PHS398 Research
Plan component of the SF424 (R&R)
Care and Use of Vertebrate Animals in Research: If vertebrate animals
are to be used in the project, the adequacy of the plans for their care
and use will be assessed. See the Other Research Plan Sections of the
PHS398 Research Plan component of the SF424 (R&R).
2.B. Additional Review Considerations
For this FOA, no specific budget information is to be submitted either with the application or just-in-time.
2.C. Sharing Research Data
Not Applicable.
2.D. Sharing Research Resources
Not Applicable.
3. Anticipated Announcement and
Award Dates
Finalists selected for interviews and those
applicants not selected for interviews will be notified in May, 2008. Awardees
will be notified in August, 2008, and awards will begin September 20, 2008.
Section VI. Award Administration
Information
1. Award Notices
If the application is under consideration for funding,
NIH will request "just-in-time" information from the applicant.
For details, applicants may refer to the NIH
Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards,
Subpart A: General.
A formal notification in the form of a Notice of
Award (NoA) will be provided to the applicant organization. The NoA signed
by the grants management officer is the authorizing document. Once all administrative
and programmatic issues have been resolved, the NoA will be generated via
email notification from the awarding component to the grantee business official.
Selection of an application for award is not an
authorization to begin performance. Any costs incurred before receipt of
the NoA are at the recipient's risk. These costs may be reimbursed only
to the extent considered allowable pre-award costs. See Section
IV.5., Funding Restrictions.
2. Administrative and National
Policy Requirements
All NIH grant and cooperative agreement awards include
the NIH Grants Policy Statement as part of the NoA. For these terms
of award, see the NIH
Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards,
Subpart A: General and Part
II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions
for Specific Types of Grants, Grantees, and Activities.
The following terms and conditions will be incorporated into the NoA and will be provided to the PD/PI and the appropriate institutional official at the time of award.
2a. When issuing statements, press releases, and other documents describing projects or programs funded as a NIH Director’s Pioneer Award, please use the following acknowledgement: "This work was funded by the National Institutes of Health through the NIH Director's Pioneer Award Program, grant number DP1-OD-xxxxxx. Information on the Pioneer Award Program is at http://nihroadmap.nih.gov/pioneer/.
2b. As indicated in the FOA, awardees are expected to commit at least 51% of their research effort to the project supported by the Pioneer Award.
2c. Awardees are expected to attend an annual symposium in the Bethesda, MD, area.
3. Reporting
Awardees will be required to submit a scientific progress report on June
1 of each year describing the progress made under this grant and to submit
a final progress report, Final Invention Statement, and Financial Status
Report at the end of the budget/project period.
Many questions are addressed
in the FAQs on the Pioneer
Award web site at http://nihroadmap.nih.gov/pioneer/faq.aspx.
We encourage any
remaining inquiries concerning this funding opportunity (e-mail is strongly preferred) and welcome
the opportunity to answer questions from potential applicants. Inquiries
may fall into three areas: scientific/research, peer review, and financial
or grants management issues:
1. Scientific/Research Contacts:
Ravi Basavappa, Ph.D.
National Institute of General Medical Sciences
National Institutes of Health
Building 45, Room 2As25, MSC 6200
Bethesda, Maryland 20892-6200
Phone: 301-594-0828
Email: [email protected] (e-mail
is the strongly preferred method for inquiries)
2. Peer Review Contact:
Ravi Basavappa, Ph.D.
National Institute of General Medical Sciences
National Institutes of Health
Building 45, Room 2As25, MSC 6200
Bethesda, Maryland 20892-6200
Phone: 301-594-0828
Email: [email protected] (e-mail
is the strongly preferred method for inquiries)
3. Financial/Grants Management Contact:
Marcia F. Cohn
Grants Management Officer
National Institute of General Medical Sciences
National Institutes of Health
Building 45, MSC 6200
Bethesda, Maryland 20892-6200
Phone: 301-594-3918
FAX: 301-480-2554
Email: [email protected]
Section VIII. Other Information
Required Federal Citations
Information responsive to the following federal citations should not be submitted with the application. Just-in-time information will be requested for those applications being considered for funding.
Use of Animals in Research:
Recipients of PHS support for activities involving
live, vertebrate animals must comply with PHS Policy on Humane Care and
Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf)
as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm),
and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm)
as applicable.
Human Subjects Protection:
Federal regulations (45 CFR 46) require that applications
and proposals involving human subjects must be evaluated with reference
to the risks to the subjects, the adequacy of protection against these risks,
the potential benefits of the research to the subjects and others, and the
importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types
of clinical trials, including physiologic toxicity and dose-finding studies
(Phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative
trials (Phase III). Monitoring should be commensurate with risk. The establishment
of data and safety monitoring boards (DSMBs) is required for multi-site
clinical trials involving interventions that entail potential risks to the
participants ( NIH Policy for Data and Safety Monitoring, NIH Guide
for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Sharing Research Data:
Not applicable.
Access to Research Data through the Freedom of Information
Act:
The Office of Management and Budget (OMB) Circular
A-110 has been revised to provide access to research data through the Freedom
of Information Act (FOIA) under some circumstances. Data that are (1) first
produced in a project that is supported in whole or in part with Federal
funds and (2) cited publicly and officially by a Federal agency in support
of an action that has the force and effect of law (i.e., a regulation) may
be accessed through FOIA. It is important for applicants to understand the
basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity
in a public archive, which can provide protections for the data and manage
the distribution for an indefinite period of time. If so, the application
should include a description of the archiving plan in the study design and
include information about this in the budget justification section of the
application. In addition, applicants should think about how to structure
informed consent statements and other human subjects procedures given the
potential for wider use of data collected under this award.
Sharing of Model Organisms:
NIH is committed to support efforts that encourage
sharing of important research resources including the sharing of model organisms
for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors
to elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh Dole Act (see the NIH Grants
Policy Statement. Beginning October 1, 2004, all investigators submitting
an NIH application or contract proposal are expected to include in the application/proposal
a description of a specific plan for sharing and distributing unique model
organism research resources generated using NIH funding or state why such
sharing is restricted or not possible. This will permit other researchers
to benefit from the resources developed with public funding. The inclusion
of a model organism sharing plan is not subject to a cost threshold in any
year and is expected to be included in all applications where the development
of model organisms is anticipated.
Inclusion of Women And Minorities in Clinical
Research:
It is the policy of the NIH that women and members
of minority groups and their sub-populations must be included in all NIH-supported
clinical research projects unless a clear and compelling justification is
provided indicating that inclusion is inappropriate with respect to the
health of the subjects or the purpose of the research. This policy results
from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43).
All investigators proposing clinical research should read the "NIH
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical
Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new
OMB standards; clarification of language governing NIH-defined Phase III
clinical trials consistent with the SF424 (R&R) application; and updated
roles and responsibilities of NIH staff and the extramural community. The
policy continues to require for all NIH-defined Phase III clinical trials
that: a) all applications or proposals and/or protocols must provide a description
of plans to conduct analyses, as appropriate, to address differences by
sex/gender and/or racial/ethnic groups, including subgroups if applicable;
and b) investigators must report annual accrual and progress in conducting
analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.
Inclusion of Children as Participants in Clinical
Research:
The NIH maintains a policy that children (i.e.,
individuals under the age of 21) must be included in all clinical research,
conducted or supported by the NIH, unless there are scientific and ethical
reasons not to include them.
All investigators proposing research involving human
subjects should read the "NIH Policy and Guidelines" on the inclusion
of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).
Required Education on the Protection of Human
Subject Participants:
NIH policy requires education on the protection
of human subject participants for all investigators submitting NIH applications
for research involving human subjects and individuals designated as key
personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs
can be found at http://stemcells.nih.gov/index.asp and
at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the NIH Human Embryonic
Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility
of the applicant to provide in the project description and elsewhere in
the application as appropriate, the official NIH identifier(s) for the hESC
line(s) to be used in the proposed research. Applications that do not provide
this information will be returned without review.
NIH Public Access Policy:
NIH-funded investigators are requested to submit
to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central
(PMC) an electronic version of the author's final manuscript upon acceptance
for publication, resulting from research supported in whole or in part with
direct costs from NIH. The author's final manuscript is defined as the final
version accepted for journal publication, and includes all modifications
from the publishing peer review process.
NIH is requesting that authors submit manuscripts
resulting from 1) currently funded NIH research projects or 2) previously
supported NIH research projects if they are accepted for publication on
or after May 2, 2005. The NIH Public Access Policy applies to all research
grant and career development award mechanisms, cooperative agreements, contracts,
Institutional and Individual Ruth L. Kirschstein National Research Service
Awards, as well as NIH intramural research studies. The Policy applies to
peer-reviewed, original research publications that have been supported in
whole or in part with direct costs from NIH, but it does not apply to book
chapters, editorials, reviews, or conference proceedings. Publications resulting
from non-NIH-supported research projects should not be submitted.
For more information about the Policy or the submission
process, please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view
the Policy or other Resources and Tools, including the Authors' Manual.
Standards for Privacy of Individually Identifiable
Health Information:
The Department of Health and Human Services (HHS)
issued final modification to the "Standards for Privacy of Individually
Identifiable Health Information", the "Privacy Rule", on
August 14, 2002. The Privacy Rule is a federal regulation under the Health
Insurance Portability and Accountability Act (HIPAA) of 1996 that governs
the protection of individually identifiable health information, and is administered
and enforced by the HHS Office for Civil Rights (OCR).
Decisions about applicability and implementation
of the Privacy Rule reside with the researcher and his/her institution.
The OCR website (http://www.hhs.gov/ocr/)
provides information on the Privacy Rule, including a complete Regulation
Text and a set of decision tools on "Am I a covered entity?" Information
on the impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and
research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be
self-contained within specified page limitations. Publicly accessible on-line
journal articles or PubMed Central (PMC) articles/manuscripts accepted for
publication that are directly relevant to the project may be included only as URLs or PMC
submission identification numbers accompanying the full reference in
either the essay or the Biographical Sketch section of the NIH grant application.
A URL or PMC submission identification number citation may be repeated in
each of these sections as appropriate. There is no limit to the number of
URLs or PMC submission identification numbers that can be cited.
Healthy People 2010:
The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of
"Healthy People 2010," a PHS-led national activity for setting
priority areas. This FOA is related to one or more of the priority areas.
Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.
Authority and Regulations: This program is described in the Catalog of Federal
Domestic Assistance at http://www.cfda.gov/ and is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review. Awards are made under the authorization of Sections
301 and 405 of the Public Health Service Act as amended (42 USC 241 and
284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and
92. All awards are subject to the terms and conditions, cost principles,
and other considerations described in the NIH Grants
Policy Statement.
The PHS strongly encourages all grant recipients
to provide a smoke-free workplace and discourage the use of all tobacco
products. In addition, Public Law 103-227, the Pro-Children Act of 1994,
prohibits smoking in certain facilities (or in some cases, any portion of
a facility) in which regular or routine education, library, day care, health
care, or early childhood development services are provided to children.
This is consistent with the PHS mission to protect and advance the physical
and mental health of the American people.
Loan Repayment Programs:
NIH encourages applications for educational loan
repayment from qualified health professionals who have made a commitment
to pursue a research career involving clinical, pediatric, contraception,
infertility, and health disparities related areas. The LRP is an important
component of NIH's efforts to recruit and retain the next generation of
researchers by providing the means for developing a research career unfettered
by the burden of student loan debt. Note that an NIH grant is not required
for eligibility and concurrent career award and LRP applications are encouraged.
The periods of career award and LRP award may overlap providing the LRP
recipient with the required commitment of time and effort, as LRP awardees
must commit at least 50% of their time (at least 20 hours per week based
on a 40 hour week) for two years to the research. For further information,
please see: http://www.lrp.nih.gov.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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