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SHARE: Pre-Submission Approval - Large Budget ($500k/year or more)
Pre-submission approval may be required ***before***the NIH application due date for applications requesting $500,000 or more in direct costs in any year. If pre-submission approval is required and not granted, your application will not be accepted. Information on R13/U13 pre-submission approval is located on the R13/U13 Guidelines page.

Investigator-initiated applications requesting budgets of**$500,000 or more in direct costs in any year (excluding consortium F&A)**, or when otherwise required by the NOFO (see Section IV of the NOFO),**must seek prior approval to submit** **at least 6 weeks before applying.**Seeking this approval earlier is even better. See below for the process to request prior approval. This policy is in place to help NINDS with budgetary planning.

Step 1: Prepare the following information

Title of the project
	Anticipated submission date
	NOFO title and number
	PI name(s) and institutional affiliations
	Description of the proposed project or draft Specific Aims 
	For multi-component projects / sub-projects:
		Include a title and brief description for all components
			The PI/lead of each component
			Include a description of how components synergize for program project or center grant mechanisms
			[OPTIONAL] A schematic or figure summarizing how the components fit together can be very helpful but not required
	Budget Information
	Excel spreadsheet or table by year including major budget categories (senior/key and other personnel, equipment, trainee support, other direct costs, etc) with direct and total cost per year
		Brief narrative description of requested budget categories
	Current PI(s) Other Support informationStep 2: Submit the information above to the appropriate Program Officer

The appropriate Program Officer can be found be either looking for the NINDS Program Officer named in Section VII of the NOFO under "Scientific/Research Contact(s)" or, if a specific or single name is not provided use the resources at Find your Program Officer.Step 3: NINDS Review and Determination

Program staff will review the information submitted and may follow-up with additional questions.
	Prior approval requests for large budget applications are reviewed for mission fit at NINDS as well as cost and priority considerations. The outcome of the prior approval request review will be communicated back to the applicant prior to the application due date.
	If prior approval is *not*granted, applicants can still reconfigure their application and submit for a budget that does not meet the prior approval threshold (less than $500,000 in direct costs in every year).
	If prior approval *is*granted, applicants must include a cover letter with their application identifying the program staff member and that NINDS has agreed to accept the application. NOTE: The budget must not exceed what was requested during the prior approval process.



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