Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

Common Fund (Roadmap). This FOA is developed as an NIH Common Fund initiative (http://nihroadmap.nih.gov) through the Office of Strategic Coordination, Division of Program Coordination, Planning and Strategic Initiatives, Office of the NIH Director (http://dpcpsi.nih.gov/osc). All NIH Institutes and Centers participate in Common Fund initiatives. This FOA is being administered by the National Institute of General Medical Sciences (NIGMS) on behalf of NIH.

Funding Opportunity Title

2012 NIH Director's Pioneer Award Program (DP1)

Activity Code

DP1 NIH Director’s Pioneer Award (NDPA)

Announcement Type

This is a reissue of RFA-RM-10-008

Related Notices
  • August 7, 2012 - This RFA has been reissued as RFA-RM-12-015.
  • September 20, 2011 - Notice of Correction to the Proposed Project Start and End Dates. See NOT-RM-11-026.
Funding Opportunity Announcement (FOA) Number

RFA-RM-11-004

Companion FOA

None

Number of Applications

There is no limit to the number of applications an institution may submit.  Applicants may submit only one application as a PD/PI in response to this FOA.  Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.310

FOA Purpose

The NIH Director’s Pioneer Award program complements NIH’s traditional, investigator-initiated grant programs by supporting individual scientists of exceptional creativity who propose pioneering and possibly transforming approaches to addressing major biomedical or behavioral challenges that have the potential to produce an unusually high impact on a broad area of biomedical or behavioral research. To be considered pioneering, the proposed research must reflect substantially different scientific directions from those already being pursued in the investigator’s laboratory or elsewhere. Awardees must commit the major portion (at least 51%) of their research efforts to the Pioneer Award project.

Key Dates
Posted Date

August 5, 2011

Open Date (Earliest Submission Date)

September 7, 2011

Letter of Intent Due Date

Not Applicable.

Application Due Date(s)

October 7, 2011, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable.

Scientific Merit Review

May, 2012

Advisory Council Review

May, 2012

Earliest Start Date(s)

September 1, 2012

Expiration Date

October 8, 2011

Due Dates for E.O. 12372

Not Applicable.

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Pioneer Awards are designed to support individual scientists of exceptional creativity who propose pioneering – and possibly transforming – 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. 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 that have the potential to improve the public health.

To be considered pioneering, the proposed research must reflect ideas substantially different from those being pursued in the investigator’s laboratory or being pursued elsewhere.  The program is not intended to expand a laboratory's funding in the area of the proposed project.  While the research direction may have as its foundation the applicant’s prior work and expertise, it cannot be an obvious extension or scale up of a current research enterprise which could be anticipated to be competitive as a new or competitive renewal R01 application.  Rather, the proposed project must reflect a fundamental new insight into the potential solution of a problem, which may derive from the development of exceptionally innovative approaches and/or from the posing of radically unconventional hypotheses. 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.  Effort expended toward teaching, administrative, or clinical duties should not be included in this calculation. Applicants with current research commitments exceeding 49% must provide a detailed explanation describing how their effort on existing grants will be adjusted to permit them to devote the required minimum effort to the Pioneer Award project.  Applicants who will not be able to meet this requirement should not submit applications.

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, now the NIH Common Fund, 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.

The NIH Director’s Pioneer Award Program is an initiative of the Common Fund (http://nihcommonfund.nih.gov/).

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New

The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications. NIH intends to commit approximately $6 million for at least 7 awards in fiscal year 2012.

Award Budget

Awards will be for up to $500,000 in direct costs each year for five years, plus applicable Facilities and Administrative (F&A) costs to be determined at the time of award.

Award Project Period

 The maximum project period is 5 years.  

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct. PD/PIs may submit only one application in response to this FOA.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed.    

Section IV. Application and Submission Information

1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

Required and Optional Components

The forms package associated with this FOA includes all applicable components, mandatory and optional.  Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

Description of the PD/PI's Most Significant Research Accomplishment: one page maximum

SF 424(R&R) Cover Component

Follow the instructions provided in the SF424 (R&R) Application Guide, with the following modifications:

Item Number 4.b:  Agency Routing Identifier Field:  Scientific Area Designation

Designate one scientific area from the list below by entering the one-digit code and the name of the scientific area.

Scientific Areas:

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

The Scientific Area Designation is to assist in assigning applications to reviewers. To select the most appropriate scientific area code for your application, you should consider whether reviewers who are knowledgeable in one or another scientific area would be most likely to appreciate the significance of the project, the innovativeness of its approaches, and its potential impact.

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

IMPORTANT: Enter only the one-digit code followed by one space and then the name of the scientific area (e.g., 1 Behavioral and Social Sciences); do not use quotation marks, dashes, or other characters.
 
Correct: 1 Behavioral and Social Sciences.   Incorrect:  “1 Behavioral and Social Sciences”; 1 – Behavioral and Social Sciences; 1: Behavioral and Social Sciences.
 
The selection of scientific area by applicants is solely to aid in selection of the most appropriate group of peer reviewers and does not in itself affect an application’s funding potential.  The application requirements and instructions are identical for all the scientific areas.  All nine scientific areas are considered as a single competition, are reviewed in the same time period and by the same panel, and compete for a single source of funds.

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

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

Item Number 13.  Proposed Project:  Enter start date:  09/30/2011; Enter end date:  7/31/2016. (Correction: Should be Item 12: Proposed Project Start Date: 9/30/2012; End Date 7/31/2017. See NOT-RM-11-026)

Item Number 15a.  Total Estimated Project Funding:  Enter $2,500,000.  (See note below.)

Item Number 15b. Total Non-Federal Funds:  Enter 0.

Item Number 15c.  Total Federal & Non-Federal Funds:  Enter $2,500,000.

Item 15d.  Estimated Program Income:  Enter 0.

Note:  The Budget Request is entered only on Line 15a and c, as described above.  Funds may be requested for personnel (including co-investigators and collaborators), supplies, equipment, sub-contracts, and other allowable costs. Only the five-year total – $2.5 million -- should be entered on Line 15a and c. Applicable Facilities and Administrative (F&A) costs will be determined at the time of award and should not be included in the budget request.  A detailed budget is not requested and will not be accepted.

SF 424(R&R) Other Project Information Component

Follow the instructions provided in the SF424 (R&R) Application Guide, with the following modifications:

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

Field 10:  Facilities & Other Resources Statement:   1 page maximum.

Field 11:  Equipment:  DO NOT USE.

Field 12:  Other Attachments:   Attach description of no more than one page describing the PD/PI’s single most significant publication or research accomplishment that supports the PD/PI's claim of innovativeness and demonstrates the PD/PI's ability to successfully conduct high-risk, high-reward research.  Applicants should submit one single accomplishment, not a summary of several accomplishments, multiple publications, or background narratives.  Publications or other documents will not be accepted. 

SF 424(R&R) Senior/Key Person Profile Expanded Component

Follow the instructions provided in the SF424 (R&R) Application Guide, with the following modifications:

PROFILE - Project Director/Principal Investigator Field:  Attach Biographical Sketch.

Attach PD/PI’s biographical sketch, two pages maximum, following the format on the Biographical Sketch Format Page shown in the Application Guide, Section 4.5. omitting Section A – Personal Statement and Section D - Research Support.  A list of current and pending support must be submitted on the SF 424 Senior/Key Person Profile Component.  No biographical sketches of potential collaborators or other key personnel are to be submitted and will not be accepted.  Information on potential collaborators is not required but may be included in the Essay.

PROFILE - Project Director/Principal Investigator; Field: Attach Current and Pending Support:  Attach a list of Current and Pending Support from all sources, including current year direct costs and percent effort devoted to each project. Use the format for Other Support shown in Section III.1.8 of the Application Guide.  Include overlap and the major goals of each project listed, both current and pending.  A statement must be included that, if chosen to receive an award, the applicant will commit a minimum of 51% of his/her research effort to the project supported by the Pioneer Award.  It is incumbent upon applicants to convince the reviewers that they will be able to devote the required minimum 51% research effort to the proposed project, and that the Pioneer Award project will be the major focus of their labs.  Applicants with current research commitments exceeding 49% must provide a detailed explanation describing how their effort on existing grants will be adjusted to permit them to devote the required minimum effort to the Pioneer Award project.  Applicants who will not be able to meeting this requirement should not submit applications.

PROFILE - Senior Key Person 1:  Do not use.  Submit information only for PD/PI.  Information on collaborators or other key personnel is not required but may be included in the Essay.

PHS398 Cover Letter Component

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

PD/PI name; Funding Opportunity Title: 2011 NIH Director’s Pioneer Award Program (DP1); and an explanation of the reason for the late submission.

See full instructions for submitting the Cover Letter Component in Section 5.2 of the Application Guide. Note: Items 3 – 6 of the Guide do not apply to Pioneer Award applications. Moreover, since this is an FOA, late applications will not be accepted due to service on study sections.

R&R or Modular Budget Component

Budgets are not required and will not be accepted for the FOA.

PHS 398 Research Plan Component

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

2.1:  Introduction to Application:  Do not use.

2.2:  Specific Aims:  Do not use.

2.3:  Research Strategy:  Upload Essay of no more than five pages here. 

In five pages or less, describe your innovative vision for addressing a major biomedical or behavioral problem or challenge, the importance of this problem or challenge, and your qualifications to engage in groundbreaking research. No detailed scientific plan should be provided since the research plan is expected to evolve during the tenure of the grant. The essay should include the following sections in the order given with the headings as shown below:

Scientific Area:  The Scientific Area must be included at the beginning of the Essay; (e.g., 1 Behavioral and Social Sciences).

Project Title: The project title must be included at the beginning of the Essay.

Project description:  What is the scientific problem or challenge 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? The writing should be at a level that conveys the significance and impact of the proposal.

Evidence of PD/PI's 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.

How the planned research differs from the PD/PI's past or current work: How does the proposed project represent a new and distinct direction for your research?  While a new research direction may have as its foundation the applicant's prior work and expertise, it cannot be an obvious extension or scale-up of a current research enterprise, which could be anticipated to be appropriate for a new or competitive renewal R01 application.  Rather, a new research direction must reflect a fundamental new insight into the potential solution of a problem, which may derive from the development of exceptionally innovative approaches and/or from the posing of radically unconventional hypotheses.  Applications for projects that are extensions of ongoing research should not be submitted. 

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

Note: 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.  Letters of collaboration will not be accepted.  Information on collaborators may be included in the Essay. 

2.4:     Inclusion Enrollment Report:  Do not use.
 
2.5:     Progress Report Publication List:  Do not use.
 
2.12:   Multiple PD/PI Leadership Plan:  Do not use.

2.13:   Consortium/Contractual Arrangements.  Do not use.

2.14:   Letters of Support:  Do not use.

2.15:   Resource Sharing Plan:  Do not use.

2.16:  Appendix:  Do not use.

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. Letters must be submitted electronically – paper copies will not be accepted. 

Applicants are responsible for monitoring the submission of their letters in the grant folder in the eRA Commons to ensure that three letters have been submitted prior to the submission deadline. 

Letters must be submitted no later than 5:00 p.m. (local time of the referee) October 7, 2011.  

To submit a letter of reference, the referee will need the following information:

Letters of reference are confidential. Applicants will not have access to the letters. E-mail confirmations will be sent 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.   

Note: Since e-mail 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 strongly encouraged to send the following to their referees or to send their referees the following link to this information:  (http://nihroadmap.nih.gov/pioneer/LettersofReferenceFormat.aspx).   
 
Instructions for Referees:

Letters must be submitted to the Commons at (https://public.era.nih.gov/commons/public/reference/submitReferenceLetter.do?mode=new) by 5:00 p.m. (local time of the referee), October 7, 2011. 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.

IMPORTANT:  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 the applicant’s 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.

Note:  The letter submission page can be accessed without signing into the Commons, and referees do not need to be registered in the Commons.  Referees must enter the following information when submitting letters:

REFEREE INFORMATION
(the individual providing the letter of reference):

APPLICANT INFORMATION (applicants must send this information to their referees):

E-mail confirmations will be sent to both the applicant and the referee following submission of the letter.  The e-mail confirmation will include a Confirmation Number that will be required when submitting revised or changed/corrected letters.  Print the confirmation e-mail for your records. 

Note:  If you submitted letters for Pioneer Award applicants in prior years, 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 Pioneer@NIH.gov.

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

Document  Name

Form/Field

Special Instructions

Abstract

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

Maximum 30 lines of text.

Public Health Relevancy Statement

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

2 – 3 sentences maximum

Facilities & Other Resources

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

One page maximum

Description of the PD/PI’s Most Significant Research Accomplishment

R&R Other Project Information Component, Field 12 (Other Attachments)

One page maximum.  Describe only the single most significant accomplishment.

Biographical Sketch

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

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

List of Current and Pending Research Support

SF424 Senior/Key Person Profile Component

Provide current year direct costs to applicant and percent effort for each project. Include a statement that if chosen to receive an award, the PI will devote a minimum of 51% of his or her research effort to the Pioneer Award project.  If appropriate, include an explanation of how effort on existing grants will be adjusted to allow the PI to devote the required minimum effort to the Pioneer Award project.

Essay

PHS 398 Research Plan, Field 2.3 (Research Strategy)

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

Human and Vertebrate Animal Subjects Plans (If applicable)

PHS 398 Research Plan Component, Fields 6-10

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


Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies; GWAS) as provided in the SF424 (R&R) Application Guide, with the following modifications:

Appendix

Appendices are not allowed and will not be accepted.  Applications that contain attachments other than those specified in this FOA may be rejected during the agency validation process.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.   

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide.  Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the Central Contractor Registration (CCR). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for responsiveness and completeness by the Center for Scientific Review, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

Post Submission Materials

Post submission materials are not allowed and will not be accepted.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

For this particular announcement, note the following:

Pioneer Award (DP1) applications are meant to support individual scientists of exceptional creativity who propose pioneering -- and possibly transforming -- approaches that, if successful, will have a major impact on a broad area of biomedical or behavioral research.  Pioneer Award applications do not require preliminary data, scientific aims, or a detailed research plan.  Accordingly, reviewers will emphasize the following

1)  the significance and innovation of the proposed project;

2)  the investigator (evidence for past innovation; and the PD/PI's demonstrated ability to devote 51% or more research effort on DP1 project); and

3) the suitability of the proposed project for the Pioneer Award mechanism, which includes evidence that the proposed research is of sufficient risk/potential impact that it is more suitable for the Pioneer Award program than for a traditional grant mechanism, and that the proposed research represents a new research direction for the PD/ID.  A new research direction is defined as a significant departure from the direction of ongoing or previously funded research in the PD/PI's laboratory.

Overall Impact

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

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

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

Investigator(s)    

Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative, do the investigators have complementary and integrated expertise?   

Innovation

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

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? 

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?  

Environment

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

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.

Protections for Human Subjects

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

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable.

Renewals

Not Applicable.

Revisions

Not Applicable.

Additional Review Considerations

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

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

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

Resource Sharing Plans

Reviewers will not comment on Resource Sharing Plans.  For this FOA, the Resource Sharing Plans will be provided as Just-In-Time information.  .

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NIGMS on behalf of the Office of the Director, NIH, using the review criteria stated above.  Those candidates identified as the most outstanding will be invited to Bethesda, MD for interviews in May, 2012.  Interviews will be conducted by a panel of distinguished outside experts.  The Director, Division of Program Coordination, Planning, and Strategic Initiatives, Office of the Director, NIH, will make the final selection of awardees based on the outcome of the initial peer review, the recommendations of the Advisory Committee to the Director, NIH, and programmatic considerations.  Final selection of awardees will be in August, 2012, in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

Applications will all be assigned to the Office of the Director, NIH, and will be administered by staff in the National Institute of General Medical Sciences. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the Advisory Committee to the Director, NIH (ACD).  The following will be considered in making funding decisions:

Appeals of review results for applications submitted to this FOA are not allowed.

3. Anticipated Announcement and Award Dates

 Applicants will be notified of the outcome of the first review phase - whether or not they have been selected for an interview -- in April, 2012.  Awardees will be notified in August, 2012.  Awards will begin in September, 2012.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

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 as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. 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.      

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

Not Applicable.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement. 

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Pre-award:

Janna P. Wehrle, Ph.D.

National Institute of General Medical Sciences
National Institutes of Health
45 Center Dr, Rm. 2AS.13B, MSC 6200
Bethesda Maryland 20892-6200
301-594-3555 (phone)
Pioneer@nih.gov

Post-Award:

Janna P. Wehrle, Ph.D.
National Institute of General Medical Sciences
National Institutes of Health
45 Center Dr, Rm. 2AS.13B, MSC 6200
Bethesda Maryland 20892-6200
301-594-0828 (phone)
wehrlej@nigms.nih.gov

Peer Review Contact(s)

Vernon Anderson, Ph.D.
National Institute of General Medical Sciences
National Institutes of Health
Building 45, Room 2As.43J, MSC 6200
Bethesda, Maryland 20892-6200
301-594-3827 (phone)
andersonve@mail.nih.gov

Financial/Grants Management Contact(s)

Nicole A. Fleisher
Grants Management Officer
National Institute of General Medical Sciences
National Institutes of Health
Building 45, MSC 6200
Bethesda, Maryland 20892-6200
Phone: 301-594-3923
FAX: 301-480-2554
Email: Fleishen@nigms.nih.gov  

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

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.


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