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 Notice of Funding Opportunity (NOFO) is developed as a Common Fund initiative through the Office of the NIH Director, Office of Strategic Coordination. All NIH Institutes and Centers participate in Common Fund initiatives.  

Funding Opportunity Title
NIH Director’s New Innovator Award Program (DP2 Clinical Trial Optional)
Activity Code

DP2 NIH Director’s New Innovator Awards

Announcement Type
Reissue of RFA-RM-23-005
Related Notices
  • August 31, 2022- Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198.
  • August 5, 2022- Implementation Details for the NIH Data Management and Sharing Policy. See Notice NOT-OD-22-189.
Funding Opportunity Number (FON)
RFA-RM-24-003
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 PD/PI in response to this NOFO. See Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s)
93.310
Funding Opportunity Purpose

The NIH Director’s New Innovator Award Program supports early stage investigators of exceptional creativity who propose bold and highly innovative research projects with the potential to produce a major impact on broad, important areas relevant to the mission of NIH. For the program to support the best possible researchers and research, applications are sought which reflect the full diversity of the research workforce. To support innovative and novel research across the vast NIH mission, individuals from diverse backgrounds (including those from underrepresented groups; see Notice of NIH’s Interest in Diversity) and from the full spectrum of eligible institutions in all geographic locations are encouraged to apply to this Notice of Funding Opportunity. Applications in all topics relevant to the broad mission of NIH are welcome, including, but not limited to, behavioral, social, biomedical, applied, and formal sciences and topics that may involve basic, translational, or clinical research. The NIH Director's New Innovator Award Program complements other ongoing efforts by NIH and its Institutes and Centers to fund early stage investigators. The NIH Director’s New Innovator Award Program is a component of the High-Risk, High-Reward Research (HRHR) Program of the NIH Common Fund.

Key Dates

Posted Date
March 19, 2024
Open Date (Earliest Submission Date)
July 19, 2024
Letter of Intent Due Date(s)

Not Applicable

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed Scientific Merit Review Advisory Council Review Earliest Start Date
August 19, 2024 Not Applicable August 19, 2024 March 2025 May 2025 July 2025

All applications are due 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.

No late applications will be accepted for this Notice of Funding Opportunity (NOFO).

Expiration Date
August 20, 2024
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

The NIH Director's New Innovator Award addresses two important goals: stimulating bold and highly innovative research and supporting promising Early Stage Investigators. The definition of Early Stage Investigator is provided here. Early Stage 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 Early Stage Investigators, it has created the NIH Director's New Innovator Award to support exceptionally creative Early Stage Investigators who propose bold and highly innovative research projects with the potential for unusually high impact. This award complements ongoing efforts by the NIH and its Institutes and Centers to fund Early Stage Investigators through R01 grants and other mechanisms. 

The NIH Director's New Innovator Award is different from traditional NIH grants in several aspects. It is designed specifically to support unusually creative investigators with bold and highly innovative research ideas at an early stage of their career when they may lack the preliminary data required for a conventional R01 grant application. The emphasis is on innovation and creativity; preliminary data are not required but may be included. 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. Given the highly innovative nature of the research, New Innovator Awardees are given unusual flexibility to pivot research direction as they see fit to maximize research impact.

To support innovative and novel research across the NIH mission, the NIH recognizes the need to foster a diverse research workforce across the nation. Talented researchers from diverse backgrounds (including individuals from underrepresented racial and ethnic groups, individuals with disabilities, individuals from disadvantaged backgrounds, and women; see Notice of NIH's Interest in Diversity), are strongly encouraged to work with their institutions to develop applications for this funding opportunity. As outstanding research is conducted at a broad spectrum of institutions, applications from the full range of eligible institutions (including institutions that provide services to underrepresented or underserved communities, those that may be less research-intensive, and from all domestic geographic locations) are encouraged to apply. Applications are welcome in all research areas broadly relevant to the mission of NIH. These areas include, but are not limited to, the behavioral, medical, natural, social, applied, and formal sciences. Research may be basic, translational, or clinical. The primary requirements are that the research be highly innovative and have the potential for unusually broad impact.

New Innovator Awards are for five years and will be issued in two multi-year funded segments with a three-year award followed by a two-year award. A PHS 2590 Non-Competing Continuation Progress Report (a “Type 4,” not a Multi-Year Funded Research Performance Progress Report (RPPR)) must be submitted in year three for funding the second award segment. Detailed Budget pages must be completed according to the special instructions provided in this NOFO.

Investigators who were not selected for an award in prior years may submit applications this year as long as they retain eligibility requirements (including ESI status) described in this NOFO; however, all applications must be submitted as “new” applications regardless of any previous submission to the program. No reference to any prior application may be included. Any reference to a prior application may be grounds for administrative withdrawal.

Prospective applicants are invited to a pre-application webinar on June 25, 2024, from 2:00-3:30 PM EDT. NIH staff will discuss the initiative and answer questions about the application and review process. Questions for the webinar should be submitted ahead of time to NewInnovatorAwards@mail.nih.gov by 11:59 PM local time on June 20, 2024. Additional questions may be taken during the webinar if time allows. Register for the webinar and join on Webex. The webinar will be recorded and posted on the New Innovator Award website.

The NIH Director's New Innovator Award is part of the High-Risk, High-Reward Research (HRHR) Program funded through the NIH Common Fund, 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.

See Section VIII. Other Information for award authorities and regulations.

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

Section II. Award Information

Funding Instrument

Grant: A financial assistance 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 How to Apply - Application Guide provides details on these application types. Only those application types listed here are allowed for this NOFO.

Clinical Trial?

Optional: Accepting applications that either propose or do not propose clinical trial(s).

Funds Available and Anticipated Number of Awards

NIH intends to commit approximately $37.7 million for approximately 30 awards in FY 2025. The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget

Awards will be in two multi-year segments, the first of three years followed by a segment of two years. The three-year segment will have an award budget up to $900,000 in Direct Costs. The two-year segment will have an award budget up to $600,000 in Direct Costs. For each segment applicable Facilities and Administrative costs (F&A) should be added.

Award Project Period

Project periods will be for five years. No cost extensions will be allowed for the Type 4 award, per NIH grants policy.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

All organizations administering an eligible parent award may apply for a supplement under this NOFO.

Higher Education Institutions

  • Public/State Controlled Institutions of Higher Education
  • Private Institutions of Higher Education

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

  • Hispanic-serving Institutions
  • Historically Black Colleges and Universities (HBCUs)
  • Tribally Controlled Colleges and Universities (TCCUs)
  • Alaska Native and Native Hawaiian Serving Institutions
  • Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

  • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
  • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

  • Small Businesses
  • For-Profit Organizations (Other than Small Businesses)

Local Governments

  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Government

  • Eligible Agencies of the Federal Government, which does not include the NIH Intramural Research Program
  • U.S. Territory or Possession

Other

  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations
Foreign Organizations

Non-domestic (non-U.S.) Entities (Foreign Organizations) 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 How to Apply - 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information. 

  • System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
    • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
    • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
  • eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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

All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. 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 their organization to develop an application for support. Individuals from diverse backgrounds, including individuals from underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

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

Applicants must meet the definition of an Early Stage Investigator (ESI) at the time of application submission. An ESI is a new investigator (defined as a PD/PI who has not competed successfully for a significant NIH independent research award) who is within 10 years of completing their terminal research degree or end of post-graduate clinical training. See the Office of Extramural Research website for a complete list of NIH awards that do not disqualify a PD/PI as a new investigator and for frequently asked questions about the NIH ESI Policy.

An extension to the 10-year period may be granted under certain circumstances (e.g., childbirth, family care responsibilities, clinical loan repayment requirements, disability or illness, natural or other disaster, etc.). It may take several weeks for the review process for the request, so applicants should plan accordingly. Note: If an applicant is not identified as an ESI in the eRA Commons, it may result in the application not being reviewed. Applicants are responsible for reviewing and/or updating their degree information in their eRA Commons account in a timely fashion.

Applicants must hold an independent research position at a domestic (U.S.) institution by September 1, 2025. For this NOFO, an “independent research position” is a position that automatically confers eligibility to the investigator (based on institutional policy) to apply for R01 grants with appropriate institutional commitment of facilities for the conduct of the proposed research. Investigators still in training or mentored status (such as postdoctoral fellows) are not eligible to apply unless they have a written commitment from the institution stating they will be in an independent faculty position by September 1, 2025. The commitment is certified by the institution's submission of the application.

Applicants may submit or have an NIH R01 or other grant application (including an ESI MIRA R35 application) pending concurrently with their NIH Director’s New Innovator Award application, but scientific overlap is not allowed per NIH policy. If a pending grant becomes active prior to the New Innovator Award, and the grant mechanism is not on the list of smaller NIH grants and awards that maintain ESI status, the applicant is no longer eligible to receive the New Innovator Award.

Awardees are required to commit at least three person-months (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.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2 Definition of Terms.

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 NOFO.

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

  • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
  • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
  • An application that has substantial overlap with another application pending appeal of initial peer review (see NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

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

Page Limitations

All page limitations described in the How to Apply – Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission

The following section supplements the instructions found in the How to Apply – Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Agency Routing Identifier:  Enter Science Area Designations in Field 4b. 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 BSS).

1 BSS - Behavioral and Social Science
2 CB - Chemical Biology
3 CTR - Clinical and Translational Research
4 IDI - Infectious Diseases and Immunology
5 IE - Instrumentation and Engineering
6 MCB - Molecular and Cellular Biology
7 NS - Neuroscience
8 HIB - High-Throughput and Integrative Biology
9 BCB - Bioinformatics 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 applicant's selection of scientific areas is used solely to aid in the assignment of panel reviewers and does not in itself affect an application’s funding potential. Application requirements and instructions are identical for all the science areas. All applications are reviewed in the same time period, with the same review criteria, and compete for a single source of dedicated 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 BSS; 7 NS

Note: The science area designations (two one-digit codes with abbreviations) must also be included at the beginning of the Essay.

Type of Application: Must be “New”.

Proposed Project: The start date should be September 1, 2025, and the end date should be August 31, 2030.

SF424(R&R) Project/Performance Site Locations

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Bibliography & References Cited: DO NOT USE. Provide essential reference citations in the essay.

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 How to Apply - Application Guide must be followed, with the following additional instructions:

Profile – Project Director/Principal Investigator Field – Current and Pending Support: Attach a list of Current and Pending Support from all sources and effort devoted to each project in person months.

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.

Research and Related Senior/Key Person Profile (Expanded) - Additional Senior/Key Person Profiles(s): DO NOT USE. Only the PD/PI may serve as senior/key personnel.

Research and Related Senior/Key Person Profile (Expanded) - Additional Biographical Sketch(es): DO NOT USE. Only the PD/PI may submit a Biographical Sketch.

R&R  Budget

All instructions in the How to Apply - Application Guide must be followed.

Although annual budgets are required in the application, the funding will be in two multi-year segments. A three-year Multi-Year-Funded award (9/1/2025 – 8/31/2028) will be issued just prior to the beginning of the project period. Near the end of the third year, a two-year Multi-Year-Funded award will be issued for years four and five of the project period (9/1/2028 – 8/31/2030).

The budgets have the following two important constraints: For the first segment ((9/1/2025 – 8/31/2028), the total Direct Cost must not exceed $900,000. For the second segment (9/1/2028 – 8/31/2030), the total Direct Cost must not exceed $600,000. These amounts do not include the F&A associated with any requested consortium/contractual costs.

Itemized budget information is not required and will not be accepted. Instead, a total requested Direct Cost amount for each annual budget period, including requests for equipment purchase, is required.

Some basic information must be completed for NIH to successfully process the budget form. For each of the five annual budget periods:

1. Select the appropriate Budget Type.

2. Provide the Budget Period Start Date and End Date – September 1 of one year and August 31 of the next calendar year, respectively.

3. Make sure Block 15 on the SF424 reflects the sum of Direct Costs plus F&A for the project.

4. Section A: Senior/Key Persons provide an entry for the PD/PI, including the appropriate level of effort, and enter $0 for Requested Salary and $0 for Fringe Benefits. Entering $0 does not imply that the PD/PI will not receive any salary or fringe benefit support from the grant.

5. In Section C: Enter the budget for any requested equipment. Provide justification using the Budget Justification.

6. In Section F: Other Direct Costs add a line item titled ‘Requested Direct Costs’ and provide the total Direct Cost request for that budget period. If equipment is requested in Section C, do not add the equipment budget in Section F. If consortium/contractual costs are requested, include only the Direct Costs (do not include associated F&A).

7. Ensure that the two budget constraints described above are met.

Budget Justification: Use to provide justification only for requested equipment. Provide a description of the equipment and its intended use in the research project.
F&A base: Also use the Budget Justification to explain any adjustments to the F&A cost, such as exclusions for equipment or additions for consortium/contractual costs.

R&R Subaward Budget

Do not complete the R&R Subaward form. All budget information should be provided on the Budget form.

PHS 398 Cover Page Supplement

All instructions in the How to Apply - Application Guide must be followed.

PHS 398 Research Plan

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

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, (3) how will risks and challenges be addressed, and (4) the applicant’s qualifications for this award without duplicating information in the biosketch. The description of the scientific plan should be written at a level appropriate for reviewers who are broadly knowledgeable but may not be directly involved in the proposed area of research. To focus the essay on the goals of the New Innovator Award and the review criteria, presenting the proposed research as a series of specific aims is discouraged. Do not provide a detailed experimental plan. 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 science areas: Provide 1-digit code and abbreviation for primary and secondary science areas at the beginning of essay. See "Agency Routing Identifier" information above for codes and format.

Project Description: Describe the scientific challenge or opportunity that you propose to address, its importance, and how addressing this would have a major impact on a broad area of research relevant to NIH. Provide the scientific context by summarizing the current landscape of the field and how your research, if successful, would extend substantially beyond current boundaries. Describe the overall approach to be taken. State prominently that to comply with the NOFO, a detailed experimental plan and extensive preliminary data are not being provided. However, the essay must be written such that reviewers have a clear sense of what is being proposed to be done and why and are convinced that the research will be performed in a robust and rigorous manner.

Innovativeness: State clearly and concisely what makes your project bold and unusually innovative in the context of the current state-of-the-art of the field. Since the approaches may be highly innovative, and hence risky, what will you do if these approaches are not successful?

Investigator qualifications: Provide evidence to support your claim of innovativeness and creativity in your prior research. For example, what personal qualities and experiences demonstrate your inclination to question paradigms and work with intellectual uncertainties, develop unique collaborations, integrate diverse sources of information, or develop novel approaches when new challenges or opportunities arise?

Suitability for the New Innovator Award program: Why is the planned research uniquely suited to the New Innovator Award rather than a more “traditional” grant mechanism?

Statement of research effort commitment: A statement must be included that, if chosen to receive an award, the applicant will commit a minimum of three person-months (25%) of their research effort to the project supported by the New Innovator Award.

Note: Any bibliographic citations provided must fit within the ten-page limit. To aid in the assessment of scientific rigor, inclusion of the most critical citations is encouraged. Figures and illustrations may be included but must also fit within the ten-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 PHS Assignment Request Form in the section for individuals who should not review the application.

Applicants considering clinical trial research are strongly advised to discuss their research with the scientifically most relevant NIH Institutes or Centers (ICs) to ensure that such research would conform to the clinical trial research policies of those ICs. Funding of applications involving clinical trials is contingent upon conformance to the policies of the IC administering the award. For a list of IC staff contacts, see https://commonfund.nih.gov/highrisk/clinical.

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 as provided in the How to Apply - Application Guide

  • For this NOFO, the Resource Sharing Plan will be expected as Just in Time information if an award is being considered.

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

  • All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.
Appendix:

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply - Application Guide.

PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply - Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the How to Apply - Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply - Application Guide must be followed.

PHS Assignment Request Form

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Since all applications are received as "Office of the Director" applications and are reviewed by Special Emphasis Panels, applicants should not request assignment to a particular review panel (integrated review group) or awarding component (NIH Institute/Center). Since letters of collaboration and biosketches of collaborators are not allowed, provide the names of collaborators and their institutional affiliations in the section for individuals who should not review the application. Also, if you wish to request that certain individuals not review your application, list their names, institutional affiliations, and the reasons why they should not serve as reviewers. NIH will consider this request but is not obligated to accept it.

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 2. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. contains information about Key Dates and times. 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. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

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 and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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 How to Apply – Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. 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 Section 7.9.1 Selected Items of Cost.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the How to Apply - 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 How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. 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 NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply - Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by the Office of Strategic Coordination (Common Fund), NIH. Applications that are incomplete, non-compliant, and/or nonresponsive will not be reviewed.

Post Submission Materials

Only documents to inform of unforeseen events, such as natural disasters, that substantially affect the ability to execute the proposed research will be accepted. No publication updates will be allowed as post-submission material.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.  Applications submitted to the NIH in support of the NIH mission 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 supports innovative research that has the potential to produce a major impact on a broad area of biomedical or behavioral research. A New Innovator Award grant application does not have extensive experimental details, and the essay focuses on the goals of the New Innovator Award. Preliminary data are not required but may be included. Accordingly, reviewers will provide comments emphasizing 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.

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

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. 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? Is the prior research that serves as the key support for the proposed project rigorous? 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?

In addition, for applications involving clinical trials

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Investigator(s)

Are the PD/PI, collaborators, and other researchers well suited to the project? If Early Stage Investigators or those 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)?  Is the PD/PI well suited to the project? Do they have appropriate experience and training?

In addition, for applications involving clinical trials

With regard to the proposed leadership for the project, do the PD/PI and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

Specific to this NOFO: Does the PD/PI have a track record of unusual innovation or creativity and of overcoming substantial technical or conceptual hurdles?

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?

In addition, for applications involving clinical trials

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

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?

In addition, for applications involving clinical trials

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

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.

Study Timeline

Specific to applications involving clinical trials

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

Protections for Human Subjects

For research that involves human subjects but does not involve one of the 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 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 Individuals Across the Lifespan

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. 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 three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals 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

Reviewers will comment on whether the Resource Sharing Plan(s) (i.e., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

Authentication of Key Biological and/or Chemical Resources:

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

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 scientific review groups 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.

For this program, depending on the number of applications submitted, proposals may be evaluated in one or more independent panels. If multiple panels are used, each will be designed to be equivalent with respect to scientific area. For each panel, the initial peer review proceeds in two phases. In the first phase, all applications submitted in response to the NOFO will be reviewed by “mail-in” reviewers assigned based on the primary and secondary areas designated by the PD/PI in the “Agency Routing Identifier” field of the application. For the second phase of review, applications will be evaluated by a second group of reviewers with broad scientific perspective who will be informed by the results of the first phase and will choose applications to discuss and score in one or more independent panel meetings. The same review criteria will be used in both phases of initial peer review.

As part of the scientific peer review, all applications will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit will be discussed and assigned an overall impact score.

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

Applications selected for funding will be assigned to the appropriate NIH Institute or Center for administration. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the Council of Councils. The following will be considered in making funding decisions:

  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Conformance to the clinical trial research policies of the administering Institute or Center.
  • Relevance of the proposed project to program priorities, including 
    • The potential for the investigator to lead research, despite its inherent risks, that is groundbreaking and broadly impactful.
    • Unusually cross-cutting science.
    • Scientific balance in the portfolio of New Innovator Award-supported research.
    • Potential to invigorate exceptionally innovative and impactful science broadly across the nation.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.

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. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

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 recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.6. 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 NOFO will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

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, Recipients, and Activities, including of note, but not limited to:

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the Laws and Regulations Enforced by the HHS Office for Civil Rights website

HHS recognizes that NIH research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to System for Award Management (SAM.gov) requirements. SAM.gov requires Federal agencies to review and consider information about an applicant in the designated integrity and performance system (currently SAM.gov) prior to making an award. An applicant can review and comment on any information in the responsibility/qualification records available in SAM.gov. NIH will consider any comments by the applicant, in addition to the information available in the responsibility/qualification records in SAM.gov, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Data Management and Sharing

Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. Reporting

Progress reports for multi-year funded awards are due annually on or before the anniversary of the budget/project period start date of award except in year 3.The reporting period for multi-year 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 using the RPPR are posted at http://grants.nih.gov/grants/policy/myf.htm

In year three, a PHS 2590 Non-Competing Continuation Progress Report (not a Multi-Year Funded Research Performance Progress Report (RPPR)) must be submitted. Administrative review will be conducted prior to issuing a Type 4 award for years four and five of the project period.

A final RPPR, 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. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 as amended (FFATA), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All recipients 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.

In accordance with the regulatory requirements provided at 2 CFR Part 200.113 and Appendix XII to 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (Responsibility/Qualification in SAM.gov, formerly FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 2 CFR Part 200 – Award Term and Conditions for Recipient Integrity and Performance Matters.

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 Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-637-3015

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Scientific/Research Contact(s)

Patricia Labosky, Ph.D.
Office of the Director (OD)
Email: NewInnovatorAwards@mail.nih.gov

Peer Review Contact(s)

Center for Scientific Review (CSR)
Email: NOFOReviewContact@csr.nih.gov

Financial/Grants Management Contact(s)

Michael Morse
Office of the Director (OD)
Telephone: 301-435-5446
Email: morsem@od.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 2 CFR Part 200.

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