Applications Requesting $500,000 or More in Direct Costs

The National Institutes of Health (NIH) has updated its policy on the acceptance of applications requesting direct costs of $500,000 or more for any one year. Effective with the January 1, 2002 receipt dates, applicants must seek agreement to accept assignment from Institute/Center staff at least 6 weeks prior to the anticipated submission of any application requesting $500,000 or more in direct costs for any year.

If staff is contacted less than 6 weeks before submission, there may be insufficient time to make a determination about assignment prior to the intended submission date. If the requested dollars are significantly greater than $500,000, then approval should be sought even earlier.

This policy does not apply to applications submitted in response to RFAs or in response to other announcements that include specific budgetary limits. However, such applications must be responsive to any budgetary limits specified, or they will be returned to applicants without review.

An applicant planning to submit a grant application (new, resubmission, revision) with $500,000 OR more in direct costs for any year is required to contact program staff in writing. This contact should be made during the development process of the application but no later than 6 weeks before the anticipated submission date.
 
The packet that will be submitted to the Program Officer should include the following:

• Official Memo from the Institutional Official to NIAAA
  • List the PI/PD, Notice of Funding Opportunity (NOFO) and anticipated submission/receipt date. 
• Abstract
• Specific Aims
• Detailed Budget (first year only)
• Budget all years
• Budget Justification
• Subcontract/Consortium (if applicable)
  • Investigators
  • Scope of work
  • Detailed budget (first year only)
  • Budget all years
  • Budget justification

If the request is approved, the PI will receive an invitation from eRA. In addition, the PI must include a cover letter with the application. The cover letter must identify the program staff member and Institute or Center that has agreed to accept assignment of the application. An eRA invitation letter may be attached to the cover letter. 

An application received without indication of prior staff concurrence and identification of program staff contacted will be returned to the applicant without review. Therefore, NIH strongly encourages applicants to contact Institute or Center staff at the earliest possible time.

For additional information about this policy, the program staff at any Institute or Center may be contacted.

Reference:

• NIH Guide Notice NOT-OD-02-004, October 16, 2001 "REVISED POLICY ON THE ACCEPTANCE FOR REVIEW OF UNSOLICITED APPLICATIONS THAT REQUEST $500,000 OR MORE IN DIRECT COSTS"
• NIH Guide Notice NOT-OD-O5-004, November 2, 2004 "REVISED POLICY ON APPLICATIONS THAT INCLUDE CONSORTIUM/CONTRACTUAL FACILITIES AND ADMINISTRATIVE COSTS"

Updated October 31, 2022