The NIH has issued Notice NOT-OD-26-019, which removes the long-standing requirement for prior approval of applications requesting $500,000 or more in direct costs per year.

Effective immediately:

Letters of Intent (LOIs)

The NIH will no longer request or accept Letters of Intent as part of the application process. Historically, LOIs were used to help Institutes and Centers (IC) estimate peer-review workload and secure appropriate reviewers. With peer review now fully centralized within the Center for Scientific Review (CSR), LOIs are no longer needed. 

Applications Requesting $500,000 or More in Direct Costs

Applications are no longer required to obtain prior approval before submitting an application with $500,000 or more in direct costs (excluding subaward F&A) in any budget period. 

Accordingly:

• A cover letter identifying the Program Officer who granted prior approval is no longer required.

• A copy of the approval itself should not be included.  

All active funding opportunities that previously contained this requirement are superseded by this Notice and will be updated. The NIH Application Guide and NIH Grants Policy Statement will also be revised in the next iterations. 

Important Consideration

Although the prior approval requirement has been eliminated, PIs planning to request direct costs substantially exceeding $500,000 (excluding subaward F&A) in any budget year are strongly encouraged to consult with their Program Official to understand any considerations that may affect funding within the intended IC. 

For questions, please contact your assigned OSRA Grants Specialist or email grantsandcontracts@med.cornell.edu.