What if my project exceeds $500,000 in direct costs in any given year?

All investigator-initiated new research grant applications exceeding $500,000 (direct costs) in any year should refer to Guidelines for Applications with Direct Costs of $500,000 or More in Any One Year for specific details and guidance on this process. The following steps summarize what is required:

• Contact NHLBI program staff far in advance of the intended receipt date to discuss the research idea or concept.
• A staff visit (either in person or by phone) must be scheduled 2-3 months in advance of the intended receipt date.  NHLBI staff will include a representative from the Program Office and Review Branch.  The Program Director will help you determine, based on the nature of your proposal, who should be included to represent the investigator team. The staff visit will provide you with guidance with respect to whether NHLBI may be willing to accept the application, what information is needed prior to receipt of the application, and the application submission and review process.  (This Checklist may help you prepare for the staff visit)
• You must submit a letter to the Director of the Division most relevant to the proposed research, requesting approval to submit an application to NHLBI (see Guidelines for Applications with Direct Costs of $500,000 or More in Any One Year for specific guidance).  The request should generally be no longer than 5 pages but must provide sufficient information about the specific aims of the research (including subprojects), the significance and/or potential impact on public health or health care of the research, annual and total direct costs and total costs, and key investigators to enable the Institute to make an informed decision about whether or not to accept a proposed application.

Since most new PPG and multicenter clinical trial applications exceed $500K in direct costs in one or more years, applicants must contact Institute staff to discuss the study and schedule a staff visit.   For renewal or supplemental applications, applicants must also contact Institute staff for guidance on pre-submission requirements.

All requests to submit applications for Phase III clinical trials with direct costs greater than $500,000 in any given year must include plans to submit at least two applications, one of which is for the support of a data coordinating center (DCC). The principal investigator for the DCC cannot be involved in (and cannot be a principal investigator on) any other award associated with the trial.  In assessing whether the budget is greater than $500,000, the budgets for the two applications are combined, not considered separately. Additional information may be found in Guidelines for Investigator Initiated Clinical Trials.