Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

Office of Strategic Coordination (Common Fund). This FOA is developed as an NIH Common Fund initiative (http://commonfund.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 Office of Strategic Coordination on behalf of the NIH.

Funding Opportunity Title

NIH Director's New Innovator Award Program (DP2)

Activity Code

DP2 NIH Director’s New Innovator Awards

Announcement Type

Reissue of RFA-RM-12-016

Related Notices

  • 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-13-007

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.310

Funding Opportunity Purpose

The NIH Director’s New Innovator (DP2) Award initiative supports a small number of early stage investigators of exceptional creativity who propose bold and highly innovative new research approaches that have the potential to produce a major impact on broad, important problems in biomedical and behavioral research. The New Innovator Award initiative complements ongoing efforts by NIH and its Institutes and Centers to fund early stage investigators through R01 grants, which continue to be the major sources of NIH support for early stage investigators. The NIH Director’s New Innovator Award initiative is a component of the High Risk - High Reward Research Program of the NIH Common Fund.

Key Dates
Posted Date

August 8, 2013

Open Date (Earliest Submission Date)

September 25, 2013, September  17, 2014, and September 16, 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 25, 2013, October, 17, 2014, and October 16, 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

April 2014, April 2015, and April 2016

Advisory Council Review

May 2014, May 2015, and May 2016

Earliest Start Date

September 2014, September 2015, and September 2016

Expiration Date

October 17, 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 Director's New Innovator Award addresses two important goals: stimulating highly innovative research and supporting promising new investigators. New investigators may have exceptionally innovative research ideas, but not the preliminary data required to fare well in the traditional NIH peer review system. As part of NIH's commitment to increasing opportunities for new scientists, it has created the NIH Director's New Innovator Award to support exceptionally creative new investigators who propose highly innovative research projects that have the potential for unusually high impact. This award complements ongoing efforts by NIH and its Institutes and Centers to fund new investigators through R01 grants and other mechanisms.

The NIH Director's New Innovator Award program is different from traditional NIH grants in several ways. It is designed specifically to support unusually creative investigators with highly innovative research ideas at an early stage of their career when they may lack the preliminary data required for an R01 grant application. The emphasis is on innovation and creativity; preliminary data are not required, but may be included. No detailed, annual budget is requested in the application. The review process emphasizes the individual’s creativity, the innovativeness of the research approaches, and the potential of the project, if successful, to have a significant impact on an important biomedical or behavioral research problem.

The research proposed for a New Innovator Award may be in any scientific area relevant to the mission of NIH (biological, behavioral, clinical, social, physical, chemical, computational, engineering, and mathematical sciences). Investigators who were not selected for an award in prior years may submit applications this year as long as they retain their ESI (early stage investigator) eligibility; however, all applications must be submitted as “new” applications regardless of any previous submission to the program.

The NIH Director's New Innovator 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 Director's New Innovator Awards initiative is a component of the Common Fund High-Risk High-Reward Research Program that also includes the NIH Pioneer Awards, the NIH Transformative Research Awards, and the NIH Director's Early Independence Awards.

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

NIH intends to commit approximately $80 million for approximately 33 awards in each of the fiscal years 2014 - 2016. The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget

Awards are multi-year funded and will be for up to the equivalent of $300,000 in Direct Costs each year for five years, plus applicable Facilities and Administrative (F&A) costs to be determined at the time of award.

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.

For the purpose of this FOA, multiple PD(s)/PI(s) are not allowed. 

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

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

Applicants are responsible for reviewing and/or updating their degree information in their eRA Commons account in a timely fashion. Applicants should allow several weeks for an extension request to be processed. NOTE: If an applicant is not identified as an ESI in the eRA Commons, it may result in the application not being reviewed.

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

Applicants may submit or have an R01 (or other equivalent) grant application pending concurrently with their New Innovator Award application. However, if that pending grant is awarded in the fiscal year of the competition (fiscal years end September 30) with a start date of September 30 or earlier in that fiscal year, then the applicant is no longer eligible to receive the New Innovator Award.

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

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

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. Only one application per PD/PI is permitted 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.

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

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

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 science area designations (twoone-digit codes and name of science areas) must also be included at the beginning of the Essay.

Type of Application: Must be “New”.

Proposed Project: The start date should be September 30 of the fiscal year and the end date should be June 30 of the fiscal year five years hence (for example, Start: 09/30/2014 and End: 06/30/2019).

Total Federal Funds Requested: Enter $1,500,000.
Total Non-Federal Funds: Enter $0.
Total Federal & Non-Federal Funds: Enter $1,500,000.
Estimated Program Income: Enter $0.

Note: The Budget Request is entered only in the fields for "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 – $1.5 million -- should be entered in the fields for "Total Federal Funds Requested" and "Total Federal & Non-Federal Funds" Lines 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.

Cover Letter: Provide names and affiliations of significant collaborators for the New Innovator Award 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 additional instructions:

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

Facilities & Other Resources: Upload a brief statement (1 page maximum) of the facilities to be used for the conduct of the research.

Equipment: DO NOT USE.

Other Attachments: DO NOT USE.

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

Profile – PD(s)/PI(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" as shown in the Application Guide. A statement must be included that, if chosen to receive an award, the applicant will commit a minimum of 25% of his/her research effort to the project supported by the New Innovator Award.

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

R&R or Modular Budget

Not Applicable

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:

Introduction to Application: DO NOT USE

Specific Aims: DO NOT USE

Research Strategy: Upload Essay here. Submit an essay that addresses (1) the significance and potential impact of the project, (2) what makes the approaches exceptionally innovative and how the applicant will address risks and challenges, and (3) the applicant’s qualifications for this award. The description of the scientific plan should be written with a level of detail appropriate for reviewers who are broadly knowledgeable but who may not be directly involved in the proposed area of research. To focus the essay on the goals of the New Innovator Award program and the review criteria for applications, presentation of the proposed research as a series of specific aims is discouraged. Preliminary data are allowed but not required. The essay should include the following sections within the page limit, in the following order, with the headings shown:

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

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

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

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

Progress Report Publication List: DO NOT USE

Multiple PD/PI Leadership Plan: DO NOT USE. Multiple PD(s)/PI(s) are not allowed.

Consortium/Contractual Arrangements: DO NOT USE

Letters of Support: DO NOT USE. Letters of Support are not allowed.

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: 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.  

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 NIH Director's New Innovator Award (DP2) grant supports innovative research that has the potential to produce a major impact on a broad area of biomedical or behavioral research.  A DP2 grant application does not have extensive background material, and the essay focuses on the goals of the New Innovator Award program. Preliminary data are not required but may be included. Accordingly, reviewers will emphasize the following: 1) the importance of the scientific problem and the potential impact of the research, 2) the novelty and innovativeness of the approach, and 3) evidence of the applicant's potential for creative and innovative research as an early stage investigator.

Applications that are complete will be reviewed in two phases by a multidisciplinary scientific review group of outside experts convened by the Center for Scientific Review on behalf of the Office of the Director and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below. Applications will initially be evaluated for scientific and technical merit by outside reviewers. Overall impact  scores and standard criterion scores will not be given. Subsequently, an editorial-style panel will consider the applications and the comments of the initial reviewers to select the most meritorious applications. These will be discussed, and the panel will determine overall impact scores for them. Applications that the panel considers less meritorious will not be discussed. The Director of the Division of Program Coordination, Planning, and Strategic Initiatives in the Office of the Director, NIH, will select awardees based on the outcomes of the scientific peer review, the recommendations of the Council level of review, programmatic considerations, and availability of funds. Notification of awardees will be in September of the fiscal year of the competition.

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

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)? Does the PD/PI devote 25% or more of his/her research effort on the New Innovator Award project each year?

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

 Since the resource sharing plans will be part of the just-in-time information, reviewers will not comment on whether the following resource sharing plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

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.

As part of the scientific peer review, all applications:

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

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 the fiscal year of each competition, applicants will be notified of their status in March, awardees will be notified in August, and 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

Progress reports for multiyear funded awards are due annually on or before the anniversary of the budget/project period start date of award. The reporting period for multiyear funded award progress report is the calendar year preceding the anniversary date of the award. Information on the content of the progress report and instructions on how to submit the report are posted at http://grants.nih.gov/grants/policy/myf.htm.

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, NIH
Telephone: 301-594-8190
Email: NewInnovatorAwards@mail.nih.gov

Peer Review Contact(s)

Rajiv Kumar, Ph.D.
Center for Scientific Review
Telephone: 301-435-1212
Email: NewInnovator_review@mail.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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