Most competing grant applications to NIH require electronic submission using the SF424 (R&R) application forms. Electronic submission involves two separate systems working together – the federal portal Grants.gov and the NIH eRA Commons. The Office of Extramural Research provides information on electronic submission and submission options. (Paper applications may only be submitted if required by the funding opportunity announcement.) The Division of Receipt and Referral (DRR) in the Center for Scientific Review (CSR) receives and checks for compliance all applications submitted to NIH. Then the DRR assigns each application: 1) to one or more institutes or centers for funding consideration and 2) to a study section (scientific review group) to evaluate the scientific and technical merit of the application.
The applicant organization submits applications prepared by the principal investigator(s) to NIH through Grants.gov, a single access point for all 26 federal grant-making agencies. The eRA Commons is an online interface where a grant applicant can check the submitted grant application for errors and warnings and view the final image.
Investigators are encouraged to include the PHS Assignment Request Form in their application. The form is optional. Use it if you wish to:
- request assignment to a specific awarding institute or center (e.g. NIMH)
- request a specific study section or that it not be assigned to a specific study section
- list individuals who should not review your application
- identify scientific areas of expertise needed to evaluate your application (do not enter names of experts)
CSR offers a number of ways to identify an appropriate study section including searching for a study section or using the CSR Assisted Referral Tool, and you can use NIH RePorter to identify where similar funded proposals were reviewed. Applicants may wish to contact scientific review officers or the DRR (301-435-0715) with specific questions about a potential assignment.
A cover letter may be included (as a PDF attachment) with your application. Cover letters may not be used for assignment requests but instead should address important information, not covered by the PHS Assignment Request Form, such as eligibility for continuous submission or the reason for a late submission.
Permission is not given in advance for a late submission. For standard due dates, NIH has established a window of consideration in which applications must be received in order to have a possibility of acceptance. All late applications must include a cover letter that provides details on the specific reasons for the delay. Further information is found in the NIH Late Application Policy. A special opportunity for continuous submission of R01, R21, and R34 applications with standard due dates is available for appointed members of NIH study sections and advisory groups. NIH Guide Notice 20-060 details the application receipt period for assignment to a particular advisory council round.
Applicants should make sure that submissions are complete and correct. The NIH policy on post submission materials limits the materials that may be accepted after submission; missing pages or corrected pages may not be submitted.
Noncompeting continuation progress reports are not sent to CSR or submitted through Grants.gov but are submitted using the PHS 2590 to a separate central location and then distributed to the funding institute or center. Contract proposals are sent directly to the soliciting institute or center and administrative supplements are sent directly to the institute or center that is funding the parent grant.
For electronic submissions, the Funding Opportunity Announcement (FOA) determines the validations that will be applied in processing receipt of the application by the NIH eRA Commons. If errors are identified in the validation process, the errors must be addressed and a changed/corrected application resubmitted to Grants.gov. Applicants are encouraged to start the submission process early enough to allow for error correction and still have an error-free, on-time submission by 5 p.m. local time on the due date.
The DRR checks for compliance with important NIH policies as follows:
- The application must be complete and must contain sufficient information for the review group to evaluate the scientific and technical merit.
- Simultaneous submissions of similar, essentially identical, or identical applications to one or more components of the PHS are not allowed.
- Resubmission applications cannot be submitted until the summary statement from review of the prior submission is posted in eRA Commons. Subsequent applications may be submitted as new (A0) or as an A1 resubmission. Resubmission applications must include an Introduction that discusses the previous review, and the text should be marked to show where changes have been made. A1 resubmission applications must be submitted within 37 months of the original application.
- Applications submitted in response to a Request for Applications (RFA) are normally new applications. If an RFA submission is not successful, a subsequent application should be submitted as a new application, not a resubmission.
- Applications that are changing activity code should also be submitted as new applications.
- Approval is needed for applications requesting $500,000 or more in direct costs: NIH policy requires that any competing application (new, renewal, resubmission, revision) requesting $500,000 or more in direct costs in any year must be accepted by an institute or center prior to assignment for review. Investigators need to contact the institute or center at least six weeks prior to the submission of the application. Note that any Facilities and Administrative costs of subcontracts are not included.
- Approval is also needed for conference grant (R13/U13) applications.
- Applications proposing research Human Embryonic Stem Cells must indicate the registration number of the cell lines to be used or include a statement that one from the NIH registry will be used.
- Format of applications: Applications are checked to make sure that they follow the font style, type size, page limits, margin size and other requirements specified in the application instructions. Noncompliant applications may be withdrawn from the review and funding consideration process.
- An eRA Commons User Name must be provided for all Principal Investigators for all applications.
- At least three reference letters are required for fellowship applications (predoctoral, postdoctoral, and senior fellowships) and mentored research career development award applications by the application due date.
Other important aspects of a grant application such as information on human subjects research, use of vertebrate animals, and plans for resource sharing are scrutinized at other stages of the grant process. Applications that do not address all the critical components may be delayed in the review process or for potential funding.