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. Dun and Bradstreet Universal Numbering System (DUNS) – All institutions must be issued a DUNS number. A DUNS number is needed to complete both SAM and eRA Commons registrations, and the same DUNS number must be used for all registrations and the grant application.
2. 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.
3. Grants.gov – Institutions must have an active DUNS number and SAM registration to complete registration.
4. 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.

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 New Innovator 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 Announcement to do otherwise. When the Funding Opportunity Announcement provides instructions that differ from the SF424 (R&R) Application Guide, the instructions given in the Funding Opportunity Announcement 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 Announcement and SF424 (R&R) Application Guide for complete instructions.

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

Important: For each of the two science area designations, enter the one-digit code followed by one space and then the corresponding abbreviation. Enter the primary area first and secondary area second. Separate the two entries by a semicolon.

Correct Example: 1 BSS; 7 NS

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

The scientific areas are used solely to aid in the assignment of panel reviewers and does not affect an application’s funding potential. Application requirements and instructions are identical for all the science areas. All applications are reviewed at the same time, by the same panel, 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 August 15, 2021, and the end date should be June 30, 2026. New Innovator Awards are multi-year funded; all the funds are disbursed in the first year of the project period. By U.S. statute, funds must be spent by the end of the fifth fiscal year. To allow time for reporting, the project period must end by June 30 of the fifth fiscal year (June 30, 2026). Money not spent by the end of the project period is subject to recovery by the U.S. Treasury. No-cost extensions are not allowed.

Estimated Project Funding

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

Note: The budget request is entered only in the fields for "Total Federal Funds Requested" and "Total Federal & Non-Federal Funds" as described above. Funds may be requested for personnel (including collaborators), supplies, equipment, sub-contracts, and other allowable costs. Only the entire project period direct cost total ($1.5 million) should be entered in the fields for "Total Federal Funds Requested" and "Total Federal & Non-Federal Funds." Applicable Facilities and Administrative (F&A) costs will be determined at the time of award and should not be included in the budget request. A detailed budget is not requested and will not be accepted.

Cover Letter Attachment

The Cover Letter Attachment must include the names of any known project personnel and/or collaborators. The cover letter is for internal NIH use only and will not be shared with peer reviewers. It is used by NIH staff to plan the review and avoid conflicts of interest.

PHS 398 Cover Page Supplement Form

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

R&R Other Project Information Form

Follow all instructions in the SF424 (R&R) Application Guide with additional instructions for the Facilities & Other Resources section outlined in the Funding Opportunity Announcement.

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. Provide essential reference citations in the essay.

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.

Project/Performance Site Location(s)

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

R&R Senior/Key Person Profile Form

Follow all instructions in the SF424 (R&R) Application Guide, with the following modifications:

• Profile - Project Director/Principal Investigator: Attach a list of current and pending support from all sources, including current year direct costs and percent effort devoted to each project.
• Profile - Senior Key Person 1: Do not use. Submit information only for the PD/PI. Information on collaborators or other key personnel is not required but may be included in the Research Strategy essay.
• Research and Related Senior/Key Person Profile (Expanded) - Additional Senior/Key Person Profile(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 Form

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

R&R Subaward Budget Attachment(s) Form

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

PHS 398 Research Plan Form

Follow all instructions in the SF424 (R&R) Application Guide with additional instructions in the Funding Opportunity Announcement.

Specific Aims

Do not use.

Research Strategy

The Research Strategy essay is the major component of the application and is limited to ten pages. The essay should address:

• The significance and potential impact of the project
• What makes the approaches exceptionally innovative
• How risks and challenges will be addressed
• The applicant’s qualifications for the award

The essay should include the following sections with headings, in order, and within the ten-page limit:

1. Project Science Areas: Provide the 1-digit code and abbreviation for primary and secondary science areas at the beginning of the essay. See "Agency Routing Identifier" information above for codes and format.
2. Project Description: The description of the scientific plan should be written at a level appropriate for reviewers who are broadly knowledgeable but may not be topic experts in the proposed area of research. Do not provide a detailed experimental plan, and do not structure the proposed research as a series of specific aims. The focus should be on the goals of the New Innovator Award and the review criteria. Preliminary data are allowed but not required. The project description should:
   • Describe the scientific challenge or opportunity that will be addressed, its importance, and how addressing this would have a major impact on a broad area of research relevant to NIH.
   • Provide scientific context by summarizing the current landscape of the field and how your research, if successful, would substantially extend beyond current boundaries.
   • Describe the overall approach to be taken.
   • State prominently that to comply with instructions in the Funding Opportunity Announcement, a detailed experimental plan and extensive preliminary data are not being provided. While details and preliminary data are not required, reviewers should still get a clear sense of what is being proposed and why and be convinced that the research will be performed in a robust and rigorous manner.
3. Innovativeness: Given what is considered state-of-the-art in the field, state clearly and concisely what makes the project unusually innovative. And since the approaches may be highly innovative and risky, what will be done if these approaches are not successful?
4. Investigator Qualifications: Provide evidence to support your claim of innovativeness and creativity in your prior research. For example, what personal qualities and experiences demonstrate your inclination to question paradigms and work with intellectual uncertainties, develop unique collaborations, integrate diverse sources of information, or develop novel approaches when new challenges or opportunities arise?
5. Suitability for the New Innovator Award Program: Why is the planned research uniquely suited to the New Innovator Award rather than a more “traditional” grant mechanism?
6. Statement of Research Effort Commitment: Include a statement affirming that if you are chosen to receive an award, you will commit a minimum of three person-months (25%) of research effort to the New Innovator Award project.

Additional Notes:

• All bibliographic citations must fit within the ten-page limit. The most critical citations should be included to aid in the assessment of scientific rigor.
• Figures and illustrations may be included but must fit within the ten-page limit.
• Letters of collaboration will not be accepted. Information on collaborators may be included in the essay and their names and affiliations should be listed in the PHS Assignment Request Form.
• Applicants considering clinical trial research are strongly advised to discuss their research with the most scientifically relevant NIH Institutes or Centers (ICs) to ensure the research conforms 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. A list of IC contacts are on our website.

Consortium/Contractual Arrangements

Do not use.

Letters of Support

Do not use. Letters of support from collaborators are not allowed.

Resource Sharing Plan

Follow all instructions in the SF424 (R&R) Application Guide, but Resource Sharing Plans will be expected as Just in Time information if an award is being considered.

Appendix

Follow all instructions in the SF424 (R&R) Application Guide. Limited materials are allowed.

PHS Human Subjects and Clinical Trials Information

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

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.

Since letters of collaboration and biosketches of collaborators are not allowed, provide the names of collaborators and their institutional affiliations. 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.

Always follow the Funding Opportunity Announcement and SF424 Application Guide's instructions for application format. Time has passed since these grantees applied, and the samples may not reflect the latest format or rules.

The text of these applications is copyrighted. You may use it only for nonprofit educational purposes provided the document remains unchanged and the PI, the grantee organization, and NIH are credited.

Note on Section 508 Conformance and Accessibility: We have reformatted these samples to improve accessibility for people with disabilities and users of assistive technology. If you have trouble accessing the content, please contact NIH staff at NewInnovatorAwards@mail.nih.gov.

Thank you to the PIs and institutions for allowing us to publicly post their New Innovator Award applications. We are grateful for their willingness to share and their assistance with this guide.

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 Announcement.

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 Announcement, late applications will not be accepted.