This standard operating procedure (SOP) includes the following sections: Purpose, Procedure, Contacts, and Links.
To support investigator-initiated research projects or training grants with total direct costs of $500,000 or more in any year of the grant.
Investigators must ask NIAID to agree to accept assignment of any investigator-initiated (unsolicited) application that requests $500,000 or more in direct costs for any year (excluding subaward facilities and administrative costs).
When determining whether to follow the big grants policy for a given application, investigators should pay attention to the type of notice of funding opportunity (NOFO) through which they are applying.
- Program Announcement (PA)—Prior approval is required for applications that have big grant budgets.
- Program Announcement With Set-Aside Funds (PAS) or Program Announcement With Special Receipt, Referral, or Review Considerations (PAR)—Prior approval is sometimes required for applications that have big grant budgets.
- If there is a specific budget limit for individual applications listed in Section II. Award Information under “Award Budget,” applicants will find further instructions in Section IV. Application and Submission Information, Part 7. Other Submission and Application Requirements under “Requests of $500,000 or more for direct costs in any year.”
- Many Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) NOFOs have unique budget limits that preclude prior approval under the big grants policy.
- Notice of Special Interest (NOSI)—Because NOSIs refer to a NOFO through which investigators can apply, the need to seek prior approval for a big grant application will depend on the particular NOFO.
- Request for Application (RFA)—Applications in response to an RFA do not require prior approval for a big grant. Still, investigators should read RFAs carefully, as they may need prior approval for some other reason.
The big grant policy applies to an application whether it is new (type 1), renewal (type 2), or a revision (type 3) as well as new (A0) or a resubmission (A1).
NIAID accepts assignment of a limited number of big grant applications and weighs their prospects carefully. The Center for Scientific Review (CSR) will return applications that lack NIAID approval to accept assignment.
Although investigators can ask for up to $499,000 without our approval, they should contact NIAID if they come anywhere close to that level for the following reasons:
- If they ask for $499,000 in the first year, the grant out years could be more than $500,000, even if they don't request an annual increase.
- We may not have money to fund applications close to $500,000. NIAID funds few big grants each year because they strain the budget and compromise grant numbers, which Congress monitors.
The NIH big grant policy also applies to multiproject applications even if none of the individual projects request $500,000 or more. It does not apply to applications submitted in response to requests for applications. For more information, see the Multiproject Awards SOP.
Clinical trial applications follow their own process—go to Investigator-Initiated Clinical Trial Resources for more information.
- If you are applying from a small business, we cannot support a clinical trial through an SBIR or STTR grant, with the exception of our NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44). For details, read Small Business Grant Application Process.
- Determine whether you need to follow the big grants policy for your chosen NOFO.
- If you are not sure, contact the program officer or grants management specialist listed in the NOFO under Section VII. Agency Contacts.
- Send a written or electronic request to the program officer listed in the notice of funding opportunity under Scientific/Research Contacts or the program officer who oversees the existing award. He or she can advise you on the feasibility of getting an award and provide guidance on the approval process.
- For P01 program project grants, send your request at least 15 weeks before you plan to apply.
- For all other grants, send your request at least six weeks before you plan to apply.
- If the request will be significantly greater than $500,000, ask for permission even earlier.
- Your program officer will send your request through an internal NIAID preapproval process. At least two weeks before your intended receipt date, you will receive a letter signed by the relevant NIAID division director or designee stating whether your request has been accepted or rejected.
- If your request is rejected, speak to the program officer about your alternatives.
- If your request is approved, attach a copy of the NIAID acceptance letter as part of your Cover Letter Attachment of the grant application when you submit your application.
- In deciding whether to agree to process a big grant preapproval request, consider program relevance, feasibility, scientific priority, and budget.
- For T32 grant applications, email the Office of Research Training and Special Programs (ORTSP) at AITrainingHelpDesk@niaid.nih.gov for approval.
- For other applications, follow your division's procedures to get approval or rejection of a request.
- If the request is approved, do the following:
- Prepare an Agreement To Accept an Application letter to be signed by either your division director or the ORTSP director for T32 applications.
- Send the signed acceptance letter to the applicant with copy to your division coordinator.
- If the request is not approved, follow your division's procedures to notify the PI.
- Review the acceptance letter for accuracy and completion. Resolve any questions with appropriate program staff.
- Ensure that funds are available.
- Initiate an electronic ARA using the eRA ARA module and attach an Agreement To Accept an Application letter.
Division of Extramural Activities
- For T32 grant applications, the ORTSP director initiates an electronic ARA using the IMPAC ARA module and attaches an Agreement To Accept an Application letter.
- NIAID Receipt and Referral staff verify the information in the ARA and submit it.
Applicants with questions should read Contacting Program Officers and Grants Management Specialists.
Office of Research Training and Special Programs—Contact for NIAID Staff
NIAID Receipt and Referral—Contact for NIAID Staff
Use the contacts listed above for questions about your specific situation. If you have a general question or a suggestion to improve this page, email the Office of Knowledge and Educational Resources at firstname.lastname@example.org.