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): Submit a Letter of Intent

Potential applicants are requested (but not required) to submit a letter of intent. Letters of Intent are non-binding and are not entered into the review of subsequent applications. The information in the letter is used by NIH staff to estimate the potential review workload and plan the review.

The letter of intent should include only the following information:

1. Descriptive title of proposed activity
2. Name, address, and telephone number of the PD/PI
3. Names of other key personnel
4. Participating institution(s)
5. Number and title of the funding opportunity

Letters of intent can be emailed to [email protected] by the date listed in the funding opportunity.

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.

The PD/PI (Program Director/Principal Investigator) mentioned in the instructions refers to the Early Independence Award candidate.

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 most appropriate scientific area for the proposal. An optional secondary scientific area may also be designated.

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). If selecting two science areas, 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 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.

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 outlined in the funding opportunity.

Facilities & Other Resources

The Facilities & Other Resources section is a critical component of the application and should be given due attention. Try to avoid boilerplate language that isn't tailored to the candidate or their needs. It may also be helpful to provide context for what resources and support are being offered. Are they standard for the institution or the field? Let reviewers know why what is being offered meets the candidate's needs and how it fits with other institutional hires and the field.

Applicant institution officials must address all the items listed in the funding opportunity for the Facilities & Other Resources section, including detailing the PD/PI’s independent research position, outlining institutional resources provided to the PD/PI, and describing the institution’s career development plan for the PD/PI. The commitment of institutional resources to the PD/PI is a major review consideration and should be suitably addressed in this section.

Responses must use the corresponding subheadings and numbering. There is no page limit.

Candidate Selection Process

Describe the process and criteria used to select the PD/PI.

Position Details

During the award period, the PD/PI must be scientifically and administratively independent. The appointment need not be permanent or tenure-track and may be contingent upon receipt of the Early Independence Award. Describe in detail the position to which the PD/PI will be appointed and how independence will be ensured during the award.

1. What is the title of the position?
2. Is the position permanent or tenure-track?
3. Is the position contingent upon receipt of the Early Independence Award?
4. Describe the position in detail.
5. How will the PD/PI's independence be ensured during the award?
6. Describe plans for maintaining protected time for the PD/PI so that they can commit at least 9.6 person-months of effort to the Early Independence Award project each year in years 1-2 of the project period. In years 3-5, the PD/PI may reduce their effort towards the Early Independence Award project but must commit at least 9.6 person-months towards general independent research each year. Clinicians should be permitted to perform clinical duties to the extent necessary to maintain credentials.
7. Describe the organizational structure where the PD/PI's position will be administered (e.g., school, department, etc.).
8. Explain how this administrative structure will best meet the goal of supporting the success of the PD/PI. Include details of responsibilities for integrating the PD/PI and their scientific project into the institutional culture and the faculty community.
9. Describe PD/PI access to potential lab personnel, such as access to postdoctoral fellows, graduate students, undergraduates, or technicians.
10. Describe management plans for potential problematic situations.
11. Describe institutional expectations related to the retention or transfer of the PD/PI at the end of the funding period.
12. Affirm that the PD/PI will be able to conduct independent research by the project start date.
13. Affirm that the institution will initiate the PD/PI appointment into the independent research position by the project start date.

Institutional Resources Commitment

1. If the candidate is not a U.S. citizen or permanent resident, the sponsoring institution must include information about the candidate's visa status and assurance that the candidate's visa provides sufficient time to complete the award at the U.S. institution.
2. Describe details of the laboratory space to be provided to the PD/PI, including physical structure and space layout.
3. Describe support staff and systems available to the PD/PI, including (but not limited to) human resources, supply and equipment ordering systems, and administrative assistance.
4. Describe the institutional financial commitment to the PD/PI. Matching funds are not required; however, an appropriate level of institutional support is expected. Institutional commitment to the development of the PD/PI as a successful and independent research scientist will be given considerable attention during the review and selection process.
5. If the PD/PI already has a commitment of funding for independent research (such as through another independent research program or institutional start-up funds), describe how the Early Independence Award will affect the other funding.

Institutional Career Development Commitment

1. Describe plans for assuring scientific independence. If the PD/PI is staying at the same institution at which they trained, indicate how independence from degree/fellowship mentors will be established and maintained.
2. Describe plans for integrating the PD/PI into scientific and administrative activities at the institution. Describe the scientific collaborative activities (e.g., attendance at faculty meetings, laboratory meetings, participation in institutional scientific retreats, etc.) and career development resources (e.g., courses in laboratory management and grant writing, etc.) that will be available to ensure the PD/PI is successful.
3. Describe the mentoring structure and include membership, meeting frequency, and meeting format. Though the PD/PI must be scientifically independent, it is important that senior colleagues are available as resources and periodically meet with the PD/PI.
4. The primary goal for the PD/PI is to establish an independent scientific research program. However, if the PD/PI has an interest in (limited) teaching, describe what opportunities will be available.
5. Describe expectations and opportunities for the PD/PI to establish a record of independent funding from sources other than the Early Independence Award.

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, 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.

6. PHS 398 Modular Budget Form

Follow all instructions in the SF424 (R&R) Application Guide. Awards will be for up to $250,000 in direct costs per year, plus applicable Facilities and Administrative (F&A) costs.

7. PHS 398 Research Plan Form

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

Specific Aims

The specific aims page has a one-page limit and must contain three sections with the following headings: "Research Objectives," "Institutional Support," and "Early Independence Rationale." These three sections should contain the information described below.

Research Objectives

• State your research topic and overall approach.
• Why is this area of research significant?
• If you have an overarching hypothesis, what is it?
• What impact will your research have if successful?
• What are the major conceptual or technical innovations your are introducing into this research area?

Institutional Support

How will the institutional support (including the assurance of research independence) help you accomplish your research objectives?

Early Independence Rationale

How will the institutional support (including the assurance of research independence) help you accomplish your research objectives?

Research Strategy

The Research Strategy essay must be organized by the ten headings listed below and effectively respond to the listed questions. The essay is the major component of the application. Your job is to convince the reviewers that (1) you are ready for independent research, (2) you have the resources and support needed to succeed, and (3) you have a significant research topic and innovative approach to addressing it. Make reviewers feel confident that you are ready and prepared to begin your independent research career and are a risk worth taking. The essay is limited to twelve pages. Remember to include your project's Science Area designations (1-digit code and abbreviation for the primary and optional secondary designations) at the top of your essay.

1. Rationale for omitting or abbreviating the typical post-doctoral phase:
   • Why would omitting or abbreviating the typical post-doctoral fellowship benefit your long-term scientific career?
   • What is driving your desire to pursue an independent research career at an earlier than usual stage?
2. Evidence of transition to an independent position:
   • Provide evidence using all the characteristics described in Section III.1. Eligible Individuals (Program Director/Principal Investigator) that at the time of application submission, you do not have research independence.
   • Describe any arrangements you may have made to assume an independent research position that would begin prior to award.
3. Personal/career development plan:
   • What particular strengths and weaknesses do you have for launching a productive independent research career?
   • How would you use this award period to build on your strengths and address your weaknesses?
   • How would receipt of this award accelerate your establishment of an independent research career (especially if you already have made an agreement for a functionally independent position)?
   • What will your planned career path be if an Early Independence Award is not provided?
4. Evidence of training ability and leadership:
   • What activities have prepared you to lead a laboratory, train laboratory staff, and perhaps mentor students and post-doctoral fellows? (Note this information may reference but should not duplicate information submitted on the Biosketch.)
5. Host institution interactions:
   • What arrangements have you made with your host institution to provide you with the support and feedback necessary to establish your research program while maintaining your intellectual independence?
   • How will you try to integrate yourself as an active member in your institution's scientific community?
6. Research challenge:
   • What is the scientific challenge that you wish to address in your research?
   • What is the premise of the project, including strengths and weaknesses of prevailing theories?
   • Why is this challenge significant to the biomedical/behavioral research community?
   • What is the expected impact of your research on this challenge?
   • Why did you choose this particular challenge to begin your independent research career?
7. Approach:
   • What is your experimental approach in addressing your research challenge? The description of the approach should convey that you have thought deeply about your project, identified the major potential pitfalls, and considered alternative approaches.
   • Address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects.
   • Preliminary data are not required but may be included. If included, they will be evaluated in the review process. You may wish to indicate prominently that substantial preliminary data are not being provided per the guidance in the funding opportunity.
   • Describe any collaborative elements of the research.
8. Innovation:
   • What are the particularly innovative aspects of your proposed research?
9. Relationship to previous work:
   • How is the proposed research related to your research as a student/trainee?
   • How does the work differ?
   • How will the work be accomplished independently from your previous mentors?
10. Timeline:
    • Affirm that you will be ready and able to conduct independent research by the project start date.
    • What is the timeline for accomplishing intermediate steps in your award period? This should include steps in establishing a functioning laboratory, meeting career development objectives, as well as achieving your scientific objectives.
    • State that you will commit at least 9.6 person-months of effort toward you Early Independence Award project each year in years 1-2. In years 3-5, you may reduce effort towards the Early Independence Award project but must commit at least 9.6 person-months towards general independent research each year.

Letters of Support

Collaborators and consultants should provide letters of support describing their commitment to the research project and their role in the research. Biosketches from collaborators and consultants are not allowed, and their inclusion anywhere in the application will result in your application being administratively withdrawn.

Other Plan(s)

All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of Direct Costs requested for any one year, must address a Data Management and Sharing Plan.

8. PHS Human Subjects and Clinical Trials Information

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

9. 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.

List the names and affiliations of significant collaborators so the Scientific Review Officer knows who is in conflict with the application and should not review it. If you wish to exclude additional 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.

Letters of reference are an important element of the Early Independence Award application. Applicants must arrange to have at least three and no more than five 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 at least 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 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.

Both letters of support and letters of recommendation are needed for the Early Independence Award application. Letters of support are attached to the application by the candidate, but letters of reference are submitted to NIH directly by the referee and are never seen by the candidate.

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 at least three and no more than five 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 is listed in eRA Commons
   • Funding opportunity number (e.g., RFA-RM-24-005)
   • URL to the eRA Commons: 
     https://public.era.nih.gov/commonsplus/public/reference/submitReferenceLetter.era
   • 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

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
   • In two pages or less, describe the PD/PI's qualities that support the PD/PI's claim to possess the scientific, leadership, mentorship, and management skills necessary to conduct successful, completely independent research. When possible, give specific examples that illustrate these qualities.
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 name, applicant's last name, funding opportunity number (e.g., RFA-RM-24-005), 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.