Part 1. Overview Information

Key Dates

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).

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.



Table of Contents
Part 1. Overview Information
Key Dates
Part 2. Full Text of Announcement
Section I. Notice of 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. Notice of Funding Opportunity Description

The NIH Director's Pioneer Award supports individual scientists of exceptional creativity who propose bold, highly innovative, and broadly impactful research towards the ultimate goal of enhancing human health.

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.

The Pioneer Award emphasizes the qualities of the investigator and the innovativeness and potential impact of the proposed research. Preliminary data and detailed experimental plans are not requested or required. To be considered pioneering and as an aspect of innovativeness, the proposed research must reflect substantially different ideas from those being pursued in the investigator’s current research program or elsewhere. The Pioneer Award is not intended to expand a current research program into the area of the proposed project. While the research direction may rely on the applicant’s prior work and expertise as its foundation, it cannot be an obvious extension or scale-up of a current research enterprise. Rather, the proposed project must reflect a fundamental new insight which may involve exceptionally innovative approaches and/or radically unconventional hypotheses. Applications for projects that are straightforward extensions of ongoing research should not be submitted.

Pioneer recipients are required to commit the major portion of their research effort (more than 6 person-months or at least 51%) to activities supported by the Pioneer Award project in the first three years of the project period. Effort expended toward teaching, administrative, or clinical duties should not be included in this calculation. Recipients may reduce effort to a minimum of 4 person-months (33%) and a minimum of 3 person-months (25%) in the fourth and fifth years, respectively, to help them transition to other sources of support since Pioneer Awards cannot be renewed. Applicants with current research commitments equal to 6 person-months or more must adjust their effort on existing grants during the award period to devote the required minimum effort to the Pioneer Award project. Investigators who will not be able to meet this requirement should not submit applications. Given the scientifically risky nature of the proposed research, award recipients will be given unusual flexibility to pivot their research direction as warranted to maximize scientific impact during the project period.

Investigators who were not selected for an award in prior years may submit applications this year as long as they retain eligibility requirements described in this NOFO; however, all applications must be submitted as “new” applications regardless of any previous submissions. 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 view a pre-recorded, pre-application webinar on the Pioneer Award website, where NIH staff discuss the initiative and answer common questions about the application and review process. Additional information and resources can be found on the website, and any questions can be sent to [email protected].

The NIH Director's Pioneer 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.

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

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

Section II. Award Information

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

Higher Education Institutions - Includes all types

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

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 Governments

• Eligible Agencies of the Federal Government, excluding 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

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. 

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 registrations; 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.

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. 

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

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement 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. Individuals may submit only one application as a PD/PI 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.

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 (Field 4b): Enter science area designations

Using the list below, designate the two most appropriate scientific areas (a primary and secondary) of the proposal. 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

For each area, enter the primary area first, followed by a semicolon, then add the secondary area (e.g., 1 BSS; 7 NS).

The areas of science listed above are very broad and frequently overlap. Choose the two science areas most appropriate for your proposed project. The scientific areas are used solely as an aid to assign panel reviewers, who are chosen for their breadth of knowledge and expertise and will be able to review a broad range of applications. Science area designations do not affect an application’s funding potential, and application requirements and instructions are identical for all 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.

Note: The science area designations (two one-digit codes with abbreviation) must also be included at the beginning of the Research Strategy essay.

Type of Application (Field 8): New

Proposed Project (Field 12): Start Date is September 1, 2026, and Ending Date is August 31, 2031

Estimated Project Funding (Field 15):

• Total Federal Funds Requested (Field 15a): $3,500,000
• Total Non-Federal Funds (Field 15b): $0
• Total Federal & Non-Federal Funds (Field 15c): $3,500,000
• Estimated Program Income (Field 15d): $0

Note: The total direct costs for the 5-year project period of the award is $3,500,000 and is entered in the "Total Federal Funds Requested" and "Total Federal & Non-Federal Funds" fields (as described above). Applicable Facilities and Administrative costs (F&A) will be determined at the time of award and should not be included in the budget request. A detailed budget and other budget forms are not required and will not be accepted. Though the information is not requested in the application, funds may be used for personnel (including collaborators), supplies, equipment, subcontracts, data management and sharing costs, and other allowable costs.

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 modifications:

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

Facilities & Other Resources Statement: 1 page maximum.

Equipment: DO NOT USE.

Other Attachments: Only attach Foreign Justification, if applicable.

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 include effort in person months devoted to each project.

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

Do not use or submit.

R&R Subaward Budget

Do not use or submit.

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: The Research Strategy section should be structured as an essay and uploaded as a pdf named “Essay.pdf.” The essay should contain the following information.

Describe your innovative vision for addressing a major challenge or pursuing an opportunity of relevance to NIH, the importance of this challenge or opportunity, and your qualifications to engage in groundbreaking research. No detailed scientific plan should be provided since the research plan is expected to evolve during the tenure of the grant. The essay should include the following sections in the order given with the headings as shown below:

Scientific 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 Title: The project title must be descriptive of the proposed project.

Project description: What is the scientific challenge or opportunity that will be addressed, and why is this important? What are the pioneering, highly innovative approaches that, if successful, would lead to groundbreaking or paradigm-shifting results? It is recommended to prominently indicate that neither a detailed experimental plan nor extensive preliminary data are being provided per the NOFO. However, the reviewers must still have a clear sense of the overall research to be pursued and must be convinced that the research will be pursued in a robust and rigorous manner. The writing should be at a level that conveys the significance and impact of the application to broadly knowledgeable scientists with different expertise domains.

Evidence of PD's/PI's innovativeness: What concrete evidence can you provide for your claim of innovativeness? For example, qualities common to many highly innovative people include the ability to integrate disparate sources of information; an inclination to question paradigms; a willingness to work with intellectual uncertainties; persistence in the face of failure; an ability to work collaboratively with researchers from multiple disciplines; and the energy and concentration necessary to plan and execute effective strategies for accomplishing goals.

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

Suitability for Pioneer Award program: Why is the planned research uniquely suited to the stated goal of the Pioneer Award 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 PD/PI will commit more than 6 person-months (at least 51%) of their research effort to the project supported by the Pioneer Award in the first three years of the award and at least 4 months (33%) research effort and at least 3 months (25%) in years four and five, respectively. Applicants with current research commitments of 6 person-months or more must provide a compelling explanation describing how their effort on existing grants will be adjusted to permit them to devote the required minimum effort to the Pioneer Award project.

Applicants considering research involving clinical trials are strongly advised to discuss their research ideas 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.

Note: References 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. 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 as individuals who should not review your application (see below).

Progress Report Publication List: Do not use.

Multiple PD/PI Leadership Plan: Do not use.

Consortium/Contractual Arrangements: Do not use.

Letters of Support: Do not use.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide.

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

Other Plan(s): 

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.

• No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

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 modifications:

Since all applications received in response to this NOFO are assigned to a single Special Emphasis Panel and initially to the Office of the Director, do not suggest assignment to a specific study section or awarding component (NIH Institute/Center). Since letters of collaboration and biosketches of collaborators are not allowed, provide the names and institutional affiliations of collaborators 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 (OSC), NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Letters of Reference

Letters of reference are an important part of the Pioneer Award application. PD/PIs must arrange to have three (and only three) letters of reference submitted on their behalf. Applications that are missing letters of reference will be considered incomplete and will not be reviewed. Late letters will not be accepted. PD/PIs are responsible for monitoring the submission of letters in their Commons account to ensure that three letters have been submitted prior to the submission deadline. Referees who submitted letters for Pioneer Award PD/PIs in prior years must submit new letters of reference this year. Previously submitted letters will not be retrieved.

Letters of reference are confidential; PD/PIs will not have access to the letters. PD/PIs should not upload letters of reference on behalf of their referees. Confirmed receipt of letters of reference will be sent via email to both the PD/PI and the referee. The confirmation sent to the PD/PI will include the referee’s name and the date and time the letter was submitted. The confirmation sent to the referee will include the referee and PD/PI's names, a confirmation number, and the date and time the letter was submitted.

Instructions to Referees

• Letters may be submitted beginning August 9, 2025, and must be submitted no later than 5:00 p.m. (local time) on September 9, 2025.
• Letters must be submitted electronically at https://public.era.nih.gov/commonsplus/public/reference/submitReferenceLetter.era (paper copies or emails will not be accepted).
  • The letter submission page can be accessed without signing in to the Commons, and referees do not need to be registered in the Commons to submit a letter.
• The PD/PI's name should be placed at the top of the letter.
• Although signatures are not required, the letter must include a signature block with the referee’s full name, title, institution, and contact information.
• In two pages or less, describe the PD/PI's qualities that support the PD/PI's claim to scientific innovativeness and creativity. When possible, give specific examples that illustrate these qualities. Address the likelihood that the applicant will conduct groundbreaking research in the proposed research area

Required Referee Information (the individual providing the letter of reference):

• Referee’s First Name
• Referee’s Last Name
• Referee’s Email Address
• Referee’s Institution/Affiliation
• Referee’s Department

Required PD/PI Information (PD/PI must provide this information to their referees):

• PD/PI's Commons User ID (Important – This must be the PD/PI's Commons User ID, not the referee’s; the letter will not be linked to the appropriate application if the PD/PI's User ID is incorrect)
• PD/PI's Last Name (Note: The name must exactly match the PD/PI's name in the Commons)
• Opportunity Number: RM-25-001
• Reference Letter Confirmation Number (required only when resubmitting a revised or corrected letter for the current funding opportunity)

Please see the detailed instructions on submitting letters of reference and Frequently Asked Questions on the Pioneer Award website. Send questions to [email protected].

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at [email protected]. 

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy

For this NOFO, only documents to inform of unforeseen events, such as natural disasters, that substantially affect the ability to execute the proposed research will be accepted.

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:

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

1. The significance and innovation of the proposed project.
2. The investigator's evidence for past innovation and the ability to commit effort that is sufficient for the proposed project.
3. A substantial change in research direction. A change in research direction is considered to be one that is a not logical extension or scale-up of ongoing efforts, but rather one that is motivated by a fundamental new insight that prompts a new line of research or a substantial departure from an existing line of research.

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.

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).

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

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.

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.

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 with the modifications as described below, 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 will receive a written critique.

• Using the review criteria stated above, those candidates identified as the most outstanding will be invited for interviews that will take place March-April 2026. Interviews will be held either virtually or in person in Bethesda, MD. Interviews will be conducted by a panel of distinguished outside experts. The same review criteria will be used during the interviews as used in the earlier stage.

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

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 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 Pioneer Award-supported research
  • Potential to invigorate exceptionally innovative and impactful science broadly across the nation

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 Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

Prior to making an award, NIH reviews an applicant’s federal award history in SAM.gov to ensure sound business practices. 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 the Responsibility/Qualification records in SAM.gov to ascertain the applicant’s integrity, business ethics, and performance record of managing Federal awards per 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.

3. Anticipated Announcement and Award Dates

PDs/PIs will be notified in April 2026 of the outcome of the first review phase - whether or not they have been selected for an interview; award recipents will be notified by August 2025. Awards will begin in September 2026.

Section VI. Award Administration Information

1. Award Notices

A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.

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.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk.  For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.

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

The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. 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.

All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations.  NIH may terminate awards under certain circumstances.  See 2 CFR Part 200.340 Termination and NIH Grants Policy Statement Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support. 

Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.

Successful recipients under this NOFO agree that:

When recipients, subrecipients, or third-party entities have:

1. ongoing and consistent access to HHS owned or operated information or operational technology systems; and
2. receive, maintain, transmit, store, access, exchange, process, or utilize personal identifiable information (PII) or personal health information (PHI) obtained from the awarding HHS agency for the purposes of executing the award.

Recipients shall develop plans and procedures, modeled after the NIST Cybersecurity framework, to protect HHS systems and data. Please refer to NIH Post-Award Monitoring and Reporting for additional information. 

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

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement Section 8.4.1 Reporting. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.

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 Section 8.6 Closeout. 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.

Section VII. Agency Contacts

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

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: [email protected] (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Patricia Labosky, Ph.D.
Office of the Director (OD)
Email: [email protected]

Center for Scientific Review (CSR)
Email: [email protected]

Email: [email protected]

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.

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.