NIH Director’s Pioneer Award Program (DP1 Clinical Trial Optional)

NIH Director’s Pioneer Award Program (DP1 Clinical Trial Optional) is sponsored by NIH Common Fund. Supports individual scientists of exceptional creativity pursuing bold, pioneering approaches to major challenges in biomedical research relevant to NIH mission. Single PI only, new research direction required.

RFA-RM-27-001: NIH Director’s Pioneer Award (DP1 Clinical Trial Optional) Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations NATIONAL INSTITUTES OF HEALTH ( NIH ) 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 Pioneer Award (DP1 Clinical Trial Optional) DP1 NIH Director's Pioneer Award (NDPA) Check for any recent Notices of NIH Policy Changes that may impact application requirements. Funding Opportunity Number (FON) Companion Funding Opportunity See Part 2, Section III. 3.

Additional Information on Eligibility. Assistance Listing Number(s) Funding Opportunity Purpose The NIH Director's Pioneer Award supports individual scientists 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.

To be considered pioneering, the proposed research must reflect substantially different scientific directions from those already being pursued in the investigator's research program or elsewhere. Applications in all topics relevant to the broad mission of NIH are welcome. Research may involve basic, translational, or clinical research.

The NIH Director's Pioneer Award is a component of the High-Risk, High-Reward Research (HRHR) program of the NIH Common Fund . Funding Opportunity Goal(s) This listing covers multiple offices in the NIH Office of the Director which offers assistance awards or supplements to assistance awards.

Open Date (Earliest Submission Date) Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed 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). 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. Use the NIH ASSIST system to prepare, submit and track your application online. 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. Use Grants.

gov Workspace to prepare and submit your application and eRA Commons to track your application. Part 1. Overview Information 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.

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.

NIH program staff will hold a pre-application webinar to explain the program and answer questions about the application and review process. Check the NIH Calendar of Events for more information. Questions should be sent to PioneerAwards@mail.

nih. gov . More information, FAQs, application guide, contacts for clinical trials, and webinar recording are on the Common Fund website .

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 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 The OER Glossary and the How to Apply - Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO. Optional: Accepting applications that either propose or do not propose clinical trial(s).

Need help determining whether you are doing a clinical trial? Funds Available and Anticipated Number of Awards NIH intends to commit approximately $8 million in FY 2027 to fund approximately 7 awards. The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Awards will be for $700,000 in Direct Costs per year, plus applicable indirect costs. The project period is limited to five years. 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 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 (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) Eligible Agencies of the Federal Government, excluding the NIH Intramural Research Program (IRP) U.S. Territory or Possession 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 Foreign Organizations/Foreign Collaborations 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. NIH will no longer issue awards (i.e., new, renewal, or non-competing continuation) to domestic or foreign entities that involve foreign subawards/subcontracts.

All NIH-funded research involving foreign subawards/subcontracts must be submitted in response to a NOFO that is specifically designated for funded international collaborations. See NIH Grants Policy Statement 16. 8 Collaborative International Research Awards .

Applications involving foreign subawards/subcontracts submitted in response to this NOFO will be deemed noncompliant and will not be considered for funding.

This policy applies to all monetary international collaborations resulting in foreign subawards/subcontracts, however, it does not preclude unfunded international collaborations or foreign components , funding for foreign consultants, or procurement of unique equipment or supplies from foreign vendors.

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. Foreign organizations must obtain a NATO Commercial and Government Entity (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.

All PD(s)/PI(s) must be registered with ORCID . The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help .

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

There is no limit to the number of applications an institution may submit, but individuals may submit only one application as PD/PI in response to this NOFO. 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 Applicant organizations may submit more than one application, provided that each application is scientifically distinct. 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 (in this NOFO, in a policy notice , or other notice from NIH Guide for Grants and Contracts ).

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

2 CTR - Clinical and Translational Research 3 IDI - Infectious Diseases and Immunology 4 IE - Instrumentation and Engineering 5 MCB - Molecular and Cellular Biology 7 HIB - High-Throughput and Integrative Biology 8 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, 2027, and Ending Date is August 31, 2032 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 indirect costs 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. 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.

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

PHS 398 Cover Page Supplement All instructions in the How to Apply - Application Guide must be followed. 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 links through the NIH Common Fund website . 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.

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions: A Data Management and Sharing Plan (DMS Plan) is required for any NIH-funded or conducted research that will generate scientific data. Applicants must submit the DMS Plan at the time of application using the NIH DMS Plan Format Page . The DMS Plan must address the elements in the structured format.

Where the DMS Plan Format Page requires a "Yes or No" response, no additional narrative is allowed. 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.

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.

Since all applications to this NOFO are received as "Office of the Director" applications and are assigned to a single Special Emphasis Panel, 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. 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. 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 components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed. 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. Referees who submitted letters for Pioneer Award PD/PIs in prior years must submit new