Before you can submit an application, you need to make sure you have all the necessary registrations and accounts. Work closely with your institution's business office to get registered and to determine its internal procedure for submitting an application to NIH.

Step 1: Ensure Applicant Institution Is Registered

Applicant institutions must complete and maintain the following registrations to apply and receive awards. Registration can take six weeks or more, so institutions should begin the registration process as soon as possible.

1. System for Award Management (SAM) – Institutions must complete and maintain an active registration, which requires an annual renewal that may take as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code. A Unique Entity Identifier (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.
2. eRA Commons – Institutions must have an active DUNS number to register. To submit an application, a Signing Official (SO) and Program Director/Principal Investigator (PD/PI) account must be designated.
3. Grants.gov – Institutions must have an active SAM registration to complete registration.

Step 2: Ensure Applicant Is Registered

The PD/PI must have an eRA Commons account. The PD/PI should work with his/her institutional officials to either create a new account or to affiliate their existing account with the applicant institution in eRA Commons. Obtaining an eRA Commons account can take up to two weeks.

Step 3: Request an Application Package

The application forms package must be accessed through one of the following systems:

• Application Submission System & Interface for Submission Tracking (ASSIST) – ASSIST is used to prepare and submit applications electronically to NIH and other Public Health Service agencies.
• Grants.gov Workspace – Workspace is the standard way for organizations or individuals to apply for federal grants in Grants.gov.
• Institutional System-to-System – See your institution’s administrative office for instructions if you plan to use an institutional system-to-system solution.

Step 4 (Optional): Contact NIH Institute or Center for Instructions on Clinical Trials

The Pioneer Award welcomes any project relevant to the NIH mission, including clinical trials. Though technical and conceptual risks are expected in highly innovative projects, clinical research must also contend with potential risks to human subjects. Because awards are administered by the most topic-relevant NIH Institute or Center (IC), applicants proposing NIH-defined clinical trials should contact program staff at the appropriate IC to ensure their applications conform to NIH and IC-specific policies for clinical trials.

For a list of IC contacts for clinical trials research, see our page on NIH Clinical Trials Contacts.

Follow the Instructions

It is critical that applicants follow the Research Instructions in the SF424 (R&R) Application Guide except where instructed in the funding opportunity to do otherwise. When the funding opportunity provides instructions that differ from the SF424 (R&R) Application Guide, the instructions given in the funding opportunity take precedence and should be followed.

All attachments should be formatted according to NIH format standards.

Adherence to the application requirements is mandatory and strictly enforced. Applications that are out of compliance with these instructions may not be accepted for review.

Required Forms

Refer to the funding opportunity and SF424 (R&R) Application Guide for complete instructions.

1. SF424 (R&R) Form

Follow all instructions in the SF424 (R&R) Application Guide.

Agency Routing Identifier

Enter Science Area Designations in the Agency Routing Identifier. 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

For each area, enter the one-digit code and abbreviation (e.g., 1 BSS). List 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 primary (and optional secondary) science area that is 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 abbreviations) must also be included at the beginning of the Research Strategy essay.

Type of Application

Must be "New."

Proposed Project

The start date should be September 30 of the funding year, and the end date should be 5 years later on July 31. See the funding opportunity for exact dates.

Estimated Project Funding

• Total Federal Funds Requested: Include Direct and Indirect Costs. Direct Costs should total $3,500,000 for the 5 years of the award.
• Total Non-Federal Funds: Enter $0.
• Total Federal & Non-Federal Funds: Include Direct and Indirect Costs.
• Estimated Program Income: Enter $0.

Note: The budget request is entered only in the fields for "Total Federal Funds Requested" and "Total Federal & Non-Federal Funds" as described above. Funds may be requested for personnel (including collaborators), supplies, equipment, sub-contracts, data management and sharing costs, and other allowable costs. A detailed budget and other budget forms are not requested and will not be accepted.

Cover Letter Attachment

Use the Cover Letter Attachment if relevant information needs to be conveyed as outlined in the SF424 (R&R) Application Guide. The cover letter is for internal NIH use only and will not be shared with peer reviewers. Note, applicants are NOT required to have agency approval documentation for budget requests of $500,000 or more because the funding opportunity expressly states that large budgets are welcome.

2. PHS 398 Cover Page Supplement Form

Follow all instructions in the SF424 (R&R) Application Guide.

3. R&R Other Project Information Form

Follow all instructions in the SF424 (R&R) Application Guide with additional instructions for the sections outlined in the funding opportunity below.

Project Summary/Abstract

There is a limit of 30 lines of text.

Project Narrative

There is a limit of three sentences.

Bibliography & References Cited

Do not use this section. Reference citations are not required. Citations considered essential may be included in the essay and must be included in the page limit.

Facilities & Other Resources

Upload a brief statement (one page maximum) of the facilities to be used for the conduct of the research.

Equipment

Do not use.

Other Attachments

Do not use.

Other Tips

• For more help on human subjects, visit the NIH Grants & Funding website.
• Foreign components are defined as the performance of any significant scientific element or segment of a project outside of the United States, either by the recipient or by a researcher employed by a foreign organization, whether or not grant funds are expended. It is crucial that you disclose all foreign components, which include foreign collaborations that will result in co-authorship. See the definition of Foreign Components for more details.

4. Project/Performance Site Location(s)

Follow all instructions in the SF424 (R&R) Application Guide.

5. R&R Senior/Key Person Profile Form

Follow all instructions in the SF424 (R&R) Application Guide, but only the PD/PI’s biosketch is allowed. Inclusion of other personnel or collaborator biosketches anywhere in the application will result in your application being administratively withdrawn.

Profile Project Director/Principal Investigator

Attach a list of Current and Pending Support from all sources, including current year direct costs and effort in person months devoted to each project.

Profile - Senior/Key Person

Do not use. Submit information for the PD/PI only. Information on collaborators and other key personnel is not required but may be included in the Research Strategy essay.

Additional Senior/Key Person Profile(s)

Do not use. Only the PD/PI may submit a Biographical Sketch. Inclusion of other personnel or collaborator biosketches anywhere in the application will result in your application being administratively withdrawn.

6. R&R Budget of Modular Budget Form

Do not use. A detailed budget is not requested and will not be accepted.

7. R&R Subaward Budget

Do not use. A detailed budget is not requested and will not be accepted.

8. PHS 398 Research Plan Form

Follow all instructions in the SF424 (R&R) Application Guide with additional instructions in the funding opportunity.

Specific Aims

Do not use.

Research Strategy

The Research Strategy essay should contain the information below and be saved as a pdf titled "Essay.pdf."

Your essay should describe:

1. Your innovative vision for addressing a major challenge or pursuing an outstanding opportunity of relevance to NIH.
2. The importance of this challenge or opportunity.
3. 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:

1. 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.
2. Project Title: The project title must be descriptive of the proposed project.
3. Project Description: Prominently indicate that neither a detailed experimental plan nor extensive preliminary data are being provided per the FOA. 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.
   • 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?
4. 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 diverse 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 diverse disciplines; and the energy and concentration necessary to plan and execute effective strategies for accomplishing goals.
5. How the Planned Research Differs from the PD's/PI's Past or Current Work: How does the proposed project represent a new and distinct direction for your research? While a new research direction may have the PDF/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 which may involve the 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.
6. 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?
7. 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 his/her 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 IC staff at 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.

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 (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

You are expected to comply with instructions for Resource Sharing Plans in the SF424 (R&R) Application Guide, but the plans will be asked for as Just in Time information if an award is being considered.

Appendix

Only limited Appendix materials are allowed as described in the SF424 (R&R) Application Guide.

9. PHS Human Subjects and Clinical Trials Information

Follow the instructions in the SF424 (R&R) Application Guide. But 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

Follow the instructions in the SF424 (R&R) Application Guide.

Delayed Onset Study

Follow the instructions in the SF424 (R&R) Application Guide. Note: Delayed onset does not apply to a study that can be described but will not start immediately (i.e., delayed start).

10. PHS Assignment Request Form

Follow all instructions in the SF424 (R&R) Application Guide, but do not request an assignment to a particular review panel (integrated review group) or awarding component (NIH Institute or Center). All applications are automatically received as "Office of the Director" applications and reviewed by a single Special Emphasis Panel convened by the Center for Scientific Review.

Provide the names of collaborators reference letter writers and their institutional affiliations so the Scientific Review Officer can avoid conflicts of interest when selecting reviewers. Also, if you wish to exclude individuals from reviewing your application, list their names, institutional affiliations, and the reasons why they should not serve as reviewers. NIH will consider your request but is not obligated to accept it.
 

Letters of reference are an important element of the Pioneer Award application. Applicants 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. Applicants are responsible for monitoring the submission of letters to ensure that three letters have been submitted prior to the submission deadline. Applicants are encouraged to check the status of their letters in their eRA Commons account.

Letters of Reference Vs. Letters of Support

Letters of reference differ from letters of support. Letters of reference are typically from scientists or others who know the applicant well and are qualified to evaluate the merit of the project proposal and the applicant’s qualifications to fulfill the proposed project. Letters of reference are submitted to NIH directly by the referee and are never seen by the PD/PI.

Letters of support typically come from outside individuals or organizations whose cooperation, assistance, or guidance is needed to successfully complete a project. The letter of support affirms the person or entity’s commitment to assist in the project. Letters of support are not permitted for the Pioneer Award application.

Referee Selection

It is best to select referees who can speak to your scientific expertise, leadership experience, and management skills and address how you are qualified to conduct successful independent research. It may not be best to choose referees based primarily on their official position, such as your departmental chair or institutional dean.

Instructions

For Applicants

1. Arrange to have three (and only three) letters.
2. Letters must be submitted by 5:00 P.M. (local time of referee) on the application due date (late letters will not be accepted).
3. Letters must be submitted electronically through eRA Commons (paper copies will not be accepted). Note: The referee does not need an eRA Commons account to submit a reference letter for an applicant, but the applicant must have a valid eRA Commons account.
4. Provide the referee with the following information:
   • Your eRA Commons user ID
   • Your last name as listed in eRA Commons
   • Funding opportunity number (e.g., RFA-RM-24-002)
   • URL to eRA Commons: https://public.era.nih.gov/commonsplus/public/reference/submitReferenceLetter.era (click on the "Submit a Reference Letter" link on the page)
   • URL to eRA help on submitting reference letters: https://www.era.nih.gov/erahelp/commons/Commons/Ref_Ltr.htm
5. You will not have access to the letters.
6. An email confirmation will be sent to you when a letter is submitted.
7. Check the status of your letters on eRA Commons periodically, and remind referees to submit their letters on time.

For Referees

For more help, see the eRA page on submitting reference letters.

1. Letter must be submitted by 5:00 P.M. (local time of referee) on the application due date (late letters will not be accepted).
2. Letter must be submitted electronically through eRA Commons (paper copies will not be accepted). Note: The referee does not need an eRA Commons account to submit a reference letter for an applicant, but the applicant must have a valid eRA Commons account.
3. Letter must include the following information:
   • PD/PI's name on top of letter
   • Signature block with your full name, title, institution, and contact information
   • 1-2 page description of the applicant's qualities relating to scientific expertise, leadership experience, and management skills necessary to conduct successful independent research (provide specific examples when possible)
4. Submit letter through eRA Commons (you do not need to be registered or logged on to eRA Commons to submit a letter).
   • Provide your first and last name, email address, institution/affiliation, and department.
   • You will need the applicant's eRA Commons user ID, applicant's last name, funding opportunity number (e.g., RFA-RM-24-002), and confirmation number (if submitting a revised Letter).
5.  An email confirmation will be sent to you when the letter is submitted.

NIH expects that applications be submitted on time, which means the application is submitted error free no later than 5:00 PM local (applicant institution) time on the application due date. There is no deadline extension to correct for errors in the application, so all errors must be corrected by the submission deadline.

Institutions often have their own internal deadlines, so be sure to check when your institution needs your application.

About Submitting

Electronic submission of your application is required. Your institution may submit using the NIH Application Submission System and Interface for Submission Tracking (ASSIST), Grants.gov Workspace, or an institutional system-to-system. If your institution uses a proprietary application system, keep in mind that the system may have its own forms, layouts, or special fields.

Regardless of the application method, all applications pass through Grants.gov for a timestamp and validation checks. To be on time, Grants.gov must successfully timestamp your application by 5:00 PM of your institution's local time on the receipt date listed in the funding opportunity.

Submitting your application may not be straightforward, so be sure to learn more about the process and work with your institution’s business office. If you encounter any problems, contact the NIH Service Desk immediately. They will document the date and time you contacted them, which is helpful in case there are delays in resolving the issue and there are downstream effects.

For technical support and information, use the following links:

• Avoiding Common Errors
• Annotated SF424 Grant Application Forms for field-by-field tips on avoiding common application mistakes
• eRA Training
• NIH Service Desk
• Grants.gov Support

Late Applications

As stated in the funding opportunity, late applications will not be accepted.