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 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 Transformative Research 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.

All page limitations described in the SF424 (R&R) Application Guide and the Table of Page Limits must be followed.

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.

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.

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.
• A Project Summary/Abstract must be included. There is a limit of 30 lines of text.
• A Project Narrative must be included. There is a limit of three sentences.

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.

6. R&R or PHS 398 Modular Budget Form

Follow all instructions in the SF424 (R&R) Application Guide. If the budget request is greater than $250,000 in direct costs per year, use the R&R Budget Form. If the budget request is equal to or less than $250,000 in direct costs per year, use the PHS 398 Modular Budget Form.

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 list specific objectives of the proposed research. Instead, describe the overall project and why it is well aligned with the objectives of the Transformative Research Award. The Specific Aims page should include two sections addressing the following questions:

1. Significance, Innovation, and Impact
   • What is the challenge or opportunity that is the focus of your proposed research?
   • Why is this broadly significant?
   • What is the overall approach you are proposing?
   • What are the most innovative aspects of your application?
   • If successful, what would the impact be on our scientific understanding and (ultimately) human health?
2. Insight and Rationale
   • What is the fundamental new insight that is motivating the proposed research?
   • What is the underlying logic or rationale that provides support for pursuing this insight despite little or no preliminary data?

The content of the two sections should be clear and compelling even to those who are not experts in the immediate field of the proposed research.

Anonymized Review Requirements

The text in the Specific Aims page must not contain any information that would allow reviewers to identify the PD(s)/PI(s), other participating individuals, or institutional affiliations.

The Specific Aims page must not include:

• Names of any individuals, whether participating or not in the proposed research
• Names of any institutions, whether participating or not in the proposed research, unless the named institution is in reference to a publicly available resource, such as a database or biobank
• Mention of any honors or awards or other specific attributes of any participating investigator
• Hyperlinks
• Reference to any investigator accomplishments in the public domain (including in publications or available in preprint servers), such as "we developed this technology," "the PIs demonstrated that," "our team was the first to," or "our collaborators are pioneers in"
• Citations that provide specific information about the source. Use numeric citations only, which refer to the corresponding source in the "Bibliography & References Cited" component of the application
• Any other text from which the identity of any participating individual or institution can be reasonably inferred

Inclusion of any text such as described above will result in the application being administratively withdrawn due to non-responsiveness.

Investigator suitability for the proposed research should be described in the biosketch, which will be available to reviewers in the last phase of review.

Research Strategy

The Research Strategy essay must be organized into five sections:

1. Overview of research project
   • Briefly describe what is being proposed and why it is important.
   • Briefly describe what is the state-of-the-art or a major challenge in the broad field of the application and how the proposed project will greatly advance and transform the broad field.
   • State the fundamental new insight that is driving the project.
2. Approach
   • Describe the overall approach to be pursued.
   • Do not include a detailed experimental plan or substantial preliminary data. If limited preliminary data are provided, they will be evaluated. The inclusion of substantial preliminary data is not aligned with the intent of the Transformative Research Award. Prominently state that, per the FOA instructions, a detailed experimental plan and substantial preliminary data are not being provided.
   • In lieu of preliminary data, provide the underlying logic or rationale for pursuing the project in the manner proposed.
   • Summarize the major challenges or risks in the project and alternate approaches that may need to be pursued.
   • Applicants proposing clinical trials may reference but should not repeat information submitted on the PHS Human Subjects Clinical Trial Information form.
   • Despite the lack of detailed plans and data, the reviewers must still ​​​​​
     1. Have a clear sense of what is being proposed and why it is important.
     2. Be convinced that the applicants have thought very deeply about the project.
     3. Be satisfied that the research will be conducted in a robust, rigorous, and reproducible manner. Thus, when vertebrate animal or human subjects are to be used, this section should include the numbers of subjects to be used and a justification for the numbers. In addition, the use of key biological variables, such as sex, should be addressed.
3. Innovation
   • Describe the elements of exceptional innovation in your proposed research and how they compare to current approaches, paradigms, practices, or perspectives.
4. Appropriateness for the Transformative Research Award
   • Why is the proposed research well suited to the goals of the Transformative Research Award program rather than a more traditional research grant program?
5. Timeline
   • Design the project to have deliverables with potential transformative impact by the end of the project period. The project should not be framed as initiating a line of research with potential transformative impact after additional periods of support.
   • Provide a timeline with points indicating where intermediate objectives will be assessed, measurable outcomes that will be used to monitor progress, and the timing and process for reaching decisions regarding the course and direction of continuing the research effort. Given the high degree of risk involved in applications submitted under the Transformative Research Award, it is anticipated that investigators will need to continually reassess approaches based on experimental outcomes and potentially alter course to meet project goals. Possible alternative paths that may be followed at critical junctures in the project plan should be indicated on the timeline.

Anonymized Review Requirements

The text in the Research Strategy essay must not contain any information that would allow reviewers to identify the PD(s)/PI(s), other participating individuals, or institutional affiliations.

The Research Strategy essay must not include:

• Names of any individuals, whether participating or not in the proposed research
• Names of any institutions, whether participating or not in the proposed research, unless the named institution is in reference to a publicly available resource, such as a database or biobank
• Mention of any honors or awards or other specific attributes of any participating investigator
• Hyperlinks
• Reference to any investigator accomplishments in the public domain (including in publications or available in preprint servers), such as "we developed this technology," "the PIs demonstrated that," "our team was the first to," or "our collaborators are pioneers in"
• Citations that provide specific information about the source. Use numeric citations only, which refer to the corresponding source in the "Bibliography & References Cited" component of the application
• Any other text from which the identity of any participating individual or institution can be reasonably inferred

Inclusion of any text such as described above will result in the application being administratively withdrawn due to non-responsiveness.

Investigator suitability for the proposed research should be described in the biosketch, which will be available to reviewers in the last phase of review.

Components of the Other Research Plan Section

The following components of Research Plan section follow the instructions in the SF424 (R&R) Application Guide:

• Vertebrate Animals
• Select Agent Research
• Multiple PD/PI Leadership Plan
• Consortium/Contractual Arrangements
• Letters of Support
• Resource Sharing Plan(s)
• Other Plan(s)
• Authentication of Key Biological and/or Chemical Reagents

9. PHS Human Subjects and Clinical Trials Information

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

Applicants considering clinical trials research are encouraged to discuss their research with the most scientifically relevant NIH Institute or Center (IC) to ensure the research conforms to the IC's clinical trials research policies. Applications must comply with the clinical trials policies of the administering IC in order to be funded. For a list of IC clinical trials staff contacts, visit the HRHR website.

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.

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 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.