Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

Division of Program Coordination, Planning and Strategic Initiatives,
Office of Strategic Coordination (Common Fund)

Funding Opportunity Title

NIH Pioneer Award Program (DP1)

Activity Code

DP1 NIH Director’s Pioneer Award (NDPA)

Announcement Type

Reissue of RFA-RM-12-015

Related Notices

  • June 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same.
  • October 18, 2013 - See Notice NOT-OD-14-003. Guidance on Resumption of NIH Extramural Activities Following the Recent Lapse in Appropriations.
  • August 21, 2013: Removed reference to ASSIST in section IV.3, since ASSIST is currently only available for multi-project applications.

Funding Opportunity Announcement (FOA) Number

RFA-RM-13-006

Companion Funding Opportunity

None

Number of Applications

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

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

93.310

Funding Opportunity Purpose

The NIH Pioneer Award initiative 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 research program or elsewhere.

Key Dates
Posted Date

August 8, 2013

Open Date (Earliest Submission Date)

September 18, 2013, September 10, 2014, and September 9, 2015

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

(Extended to November 1, 2013 per NOT-OD-14-003), Originally October 18, 2013, October 10, 2014, and October 9, 2015, by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

May 2014, May 2015, and May 2016

Advisory Council Review

May 2014, May 2015, and May 2016

Earliest Start Date

September 2014, September 2015, and September 2016

Expiration Date

October 10, 2015

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (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.


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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

The NIH Pioneer Award initiative is part of the NIH Common Fund (formerly known as the NIH Roadmap), which supports cross-cutting programs that are expected to have exceptionally high impact.  All Common Fund initiatives invite investigators to develop bold, innovative, and often risky approaches to address problems that may seem intractable or to seize new opportunities that offer the potential for rapid progress. The NIH Pioneer Awards initiative is a component of the Common Fund High-Risk Research Program that also includes the NIH Director's New Innovator Awards, the NIH Transformative Research Awards, and the NIH Director's Early Independence Awards.

To be considered pioneering, the proposed research must reflect ideas substantially different from those being pursued in the investigator’s research program or being pursued elsewhere.  The program is not intended to expand a current research program'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 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 research project.  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.

Section II. Award Information
Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The NIH intends to commit approximately $5,000,000   for approximately 7 awards in each fiscal year 2014 - 2016.

Award Budget

Awards will be for $500,000 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

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

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(s)/Principal Investigator(s) (PD(s)/PI(s)) 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.

Only single PD/PI applications are allowed. Applications with multiple PD(s)/PI(s) will not be accepted.

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(s)/PI(s) may submit only one application in response to this FOA.

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

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.

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:

Required and Optional Components

The forms package associated with this FOA includes all applicable components, required 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.

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

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

Agency Routing Identifier Field:  Enter Science Area Designations. Designate two scientific areas (a primary and secondary) from the list below. For each area, enter the one-digit code and abbreviation (e.g., 1 BBS). 

1 BBS - Behavioral and Social Science

2 CB - Chemical Biology

3 CTR - Clinical and Translational Research

4 IMM - Immunology

5 IE - Instrumentation and Engineering

6 MCB - Molecular and Cellular Biology

7 NS - Neuroscience

8 HIB - High-Throughput and Integrative Biology

9 QCB - Quantitative and Computational Biology

The Science Area Designations are to assist in assigning applications to reviewers. The science areas are very broad and frequently overlapping. Pioneer Award reviewers are chosen for their breadth of knowledge and expertise and their ability to review a broad range of applications. Choose the primary and secondary science areas that are most appropriate for your proposed project. Choose the two science areas that are most appropriate for your proposed project.

IMPORTANT: For each of the two science area designations enter the one-digit code followed by one space and then the corresponding abbreviation. Enter the primary area first and secondary area second. Separate the two entries by a semicolon.

 Correct Example: 1 BBS; 7 NS

Note: The two scientific area designations (one digit code and abbreviation for each) must also be included at the beginning of the Essay. 

Type of Application:  Must be “New”.

Proposed Project:  For start date, enter September 30 of the fiscal year of the competition and for end date, enter July 31 of the fiscal year five years hence (for example, Start date: 09/30/2014 and End date: 07/31/2019.

Total Federal Funds Requested:  Enter $2,500,000.  (See note below.)

Total Non-Federal Funds:  Enter $0.

Total Federal & Non-Federal Funds:  Enter $2,500,000.

Estimated Program Income:  Enter $0.

Note:  The Budget Request is entered only in Fields "Total Federal Funds Requested" and "Total Federal & Non-Federal Funds" as described above.  Funds may be requested for personnel (including collaborators), supplies, equipment, sub-contracts, and other allowable costs. Only the five-year total – $2.5 million -- should be entered in Fields "Total Federal Funds Requested" and "Total Federal & Non-Federal Funds" . 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.

Cover Letter: List significant collaborators for proposed Pioneer Aware project. Letters of collaboration and biosketches of collaborators are not allowed. Provision of names here is only to help exclude conflicts during reviewer assignment. Information regarding any collaborators may be included in the Essay

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Other Project Information

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

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

Facilities & Other Resources Statement:   1 page maximum.

Equipment:  DO NOT USE.

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

SF424(R&R) Senior/Key Person Profile

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

Profile - Project Director/Principal Investigator FieldAttach Biographical Sketch: Attach PD(s)/PI(s) biographical sketch, two pages maximum, following the format on the Biographical Sketch Format Page shown in the Application Guide, omit 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(s)/Principal Investigator(s) - 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 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(s)/PI(s).  Information on collaborators or other key personnel is not required but may be included in the Essay.

R&R or Modular Budget

Given the lack of a detailed research plan in the application, budgets are not required and will not be accepted for this FOA.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Research Plan

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 the Essay here. 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:   Provide 1-digit code and abbreviation for primary and secondary science areas at beginning of essay. See "Agency Routing Identifier" information above for codes and format.

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 application to broadly knowledgeable scientists with different expertise domains.

Evidence of PD(s)/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(s)/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 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 and their names and affiliations should be listed in the Cover Letter Component. 

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

Consortium/Contractual Arrangements:  Do not use.

Letters of Support:  Do not use.

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 modification:

Appendix: Appendix materials are not allowed.

Planned Enrollment Report

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. 

PHS 398 Cumulative Inclusion Enrollment Report

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide. 

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to 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. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

Applicants are responsible for viewing their application before the due date 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 SF424 (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(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(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. See Section III of this FOA for information on registration requirements.

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 System for Award Management. 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 completeness by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

Letters of Reference:

Letters of reference are an important part 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 will be considered non-responsive and will 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) on the Application Due Date of the competition (October 18, 2013; October 10, 2014; or October 9, 2015).

To submit a letter of reference, the referee (the individual submitting the letter) will need the following information:

Funding Opportunity Number (FOA) for this announcement:  RFA-RM-13-006;

The PD/PI's (Applicant's) Commons User Name -  (Note:  Referees do not need to be registered   in the Commons and do not need their own Commons User Name – only the PD/PI's (Applicant's) Commons User Name is required);

The applicant’s first and last name (note – the name must match exactly the applicant’s name in the Commons);

The URL to the letter submission page: (https://public.era.nih.gov/commons/public/reference/submitReferenceLetter.do?mode=new); and

The letter of reference submission deadline: – The deadline for receipt of letters is 5:00 p.m. (local time of the referee) on the Application Due Date of the competition (October 18, 2013; October 10, 2014; or October 9, 2015).

Letters of reference are confidential. Applicants will not have access to the letters. Email 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 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 strongly encouraged to send the following to their referees or to send their referees the following link to this information:  (https://commonfund.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), on the Application Due Date of the competition (October 18, 2013; October 10, 2014; or October 9, 2015). Late letters will not be accepted and applications with fewer than three letters will 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):

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 submitting revised or changed/corrected letters.  Print the confirmation email for your records. 

Note:  Referees who submitted letters for Pioneer Award applicants in prior years 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 (https://commonfund.nih.gov/pioneer/LettersofReferenceFormat.aspx), and the Frequently Asked Questions at (https://commonfund.nih.gov/pioneer/faq.aspx).  Send question to Pioneer@NIH.gov.

Post-Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

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:

The 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(s)/P('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(s)/PI(s).  A new research direction is defined as a significant departure from the direction of ongoing or previously funded research in the PD(s)/PI(s) laboratory.

Overall Impact

Reviewers will provide an overall impact 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.  An application does not need to be strong in all categories to be judged likely to have major scientific impact.

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(s)/PI(s), 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)?

Innovation

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

Approach

 Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the project?

Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? 

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

Environment

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

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact 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 Guidelines for the Review of Human Subjects.

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 Guidelines for the Review of Inclusion in Clinical Research.

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 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

Not Applicable

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 the Center for Scientific Review, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.  Using the review criteria stated above, those candidates identified as the most outstanding will be invited to Bethesda, MD for interviews in May of the fiscal year of the competition. Interviews will be conducted by a panel of distinguished outside experts.

As part of the scientific peer review, all applications:

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

Applications will be assigned   to the appropriate NIH Institute or Center. 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 appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

Within each fiscal year of competition, applicants will be notified in April of the outcome of the first review phase - whether or not they have been selected for an interview;awardees will be notified in August; awards will begin in September.

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, SAM 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 annual Non-Competing Progress Report (PHS 2590 or RPPR) 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

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
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

Scientific/Research Contact(s)

Ravi Basavappa, Ph.D.
Office of the Director
Telephone: 301-435-7204
Email: PioneerAwards@mail.nih.gov

Peer Review Contact(s)

James Mack, Ph.D.
Center for Scientific Review
Telephone: 301-435-2037
Email: mackj2@csr.nih.gov

Financial/Grants Management Contact(s)

Michael G. Morse
Office of the Director, NIH
Telephone: 301-435-5446
Email: morsem@mail.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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