In Advance Permission Situations
If your budget is going to exceed $500,000 in direct costs for any year of the project, NIH policy requires prior approval from Institute or Center Program staff at least six weeks prior to the anticipated submission date. Information regarding this approval will need to be submitted in a cover letter (see: Using a Cover Letter for more information) with your application. Program staff should also be contacted to obtain the latest information regarding NIMH research priorities.
You will need to know if a Letter of Intent is requested for the announcement to which you are responding. Please submit if requested.