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 unique organization identifier 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 their 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 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 (in Field 4b). Using the list below, designate the two most appropriate scientific areas (a primary and secondary) for the proposal.

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 1st of the funding year, and the end date should be August 31st, 5 years after the start year.

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 Facilities & Other Resources section outlined in the funding opportunity.

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.

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, 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 in person-months.
• 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.

6. R&R Budget Form

Although annual budgets are required in the application, the funding will be in two multi-year segments. A three-year multi-year-funded award will be issued just prior to the beginning of the project period. Near the end of the third year, a two-year multi-year-funded award will be issued for years four and five of the project period.

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

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

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

1. Select the appropriate Budget Type.
2. Provide the Budget Period Start Date and End Date – September 1 of one year and August 31 of the next calendar year, respectively.
3. Make sure Block 15 on the SF424 reflects the sum of Direct Costs plus Indirect Costs (F&A) for the project.
4. Section A: Senior/Key Persons provide an entry for the PD/PI, including the appropriate level of effort, and enter $0 for Requested Salary and $0 for Fringe Benefits. Entering $0 does not imply that the PD/PI will not receive any salary or fringe benefit support from the grant.
5. In Section C: Enter the budget for any requested equipment. Provide justification using the Budget Justification.
6. In Section F: Other Direct Costs add a line item titled ‘Requested Direct Costs’ and provide the total Direct Cost request for that budget period. If equipment is requested in Section C, do not add the equipment budget in Section F. If consortium/contractual costs are requested, include only the Direct Costs (do not include associated Indirect Costs (F&A)).
7. Ensure that the two budget constraints described above are met.

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

7. R&R Subaward Budget Attachment(s) Form

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

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 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, 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.

9. PHS Human Subjects and Clinical Trials Information

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

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.

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.

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.