General budget instructions are in Section IV, Application and Submission Information, of the Notice of Funding Opportunity.
The budget must clearly separate the following three types of costs:
Cost category | What it includes |
| Extramural costs | Costs for the extramural investigator and the applicant organization. |
| NIH intramural investigator costs | Project-specific costs needed by the NIH intramural investigator. Some ICs may cover these costs. Contact the IC representative listed in the NOFO for that IC's policy. |
| NIH Clinical Center costs | Study drug costs that the NIH Clinical Center will incur because of the proposed research project. |
NIH Clinical Center Study Drug Costs
The only NIH Clinical Center costs that may be included in the U01 budget are costs for drugs being studied as part of the project.
- Industry partnerships: When possible, investigators should work with pharmaceutical partners to reduce study drug costs.
- Clinical Center or grant support: The NIH Clinical Center LOS will state whether the Clinical Center can cover any study drug costs.
- High-cost treatments: Study drug costs expected to exceed $25,000 per year must be paid by the grant, the supporting IC, or an industry partner.
Questions about the budget structure should be sent to [email protected].