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Opportunities for Collaborative Research at the Clinical Center (U01)


General budget instructions can be found in the Funding Opportunity Announcement in Section IV. Application and Submission Information.

The budget request for this opportunity must distinguish between:

  1. Extramural costs are associated with the extramural investigator and the applicant organization.
  2. NIH intramural investigator costs are those required by the intramural investigator for carrying out the proposed work and which are specifically linked to a project. Some ICs provide funding support for the intramural research costs. Please contact your IC contact listed in the FOA for more information about your IC's policy.
  3. NIH Clinical Center costs are study-related drug costs to the Clinical Center that directly result from the proposed research project.

NIH Clinical Center Costs

The only NIH Clinical Center costs which may be included in the budget section of the application are the cost of drugs that are the subject of the study. It is recommended that, when possible, investigators work with pharmaceutical partners to minimize the cost of the study drugs. The Letter of Support from the NIH Clinical Center will indicate whether or not the CC is able to absorb the cost of any of the study drugs. Expensive treatments (i.e. protocols with drug costs expected to exceed $25,000/yr) will need to be paid for by the grant, by the IC, or through industry sponsorship.

To allow ample time for confirming the NIH Clinical Center costs, investigators should submit a budget template to no later than March 1st. Please follow the process below.

  1. The extramural applicant should work with the intramural investigator to determine if it is necessary to complete the Budget Template Microsoft Excel Icon.
    • The Budget Template contains instructions and cost building tools for Clinical Center costs due to study drugs.
  2. The intramural investigator should send the completed Budget Template to the Collaborative U01 team at
  3. The Collaborative U01 team will work with the intramural investigator to determine accurate Clinical Center costs based on the completed template.
    • Determining accurate Clinical Center costs may require several communications with the Collaborative U01 team.
  4. The intramural investigator will receive an email from the Collaborative U01 team with the finalized Budget Template confirming accurate Clinical Center costs.
  5. The extramural applicant should use the descriptor "NIH Clinical Center Costs" and enter the amount as a "subaward" budget in the budget section of the application.
    • Please see Section 4.8 of the SF 424 application instructions for additional information on entering a subaward budget.
    • The subaward budget form will require the DUNS #, Congressional District, and address for the Clinical Center (and any other institute requesting subaward funds). Please contact the for the NIH Clinical Center information.
  6. The extramural applicant must attach the Budget Template and any additional justification and documentation as appropriate to the application.
    • Be sure to list the key personnel and their percent-effort (or "calendar months") on the project. Even though award funds cannot be used to pay the salaries of intramural government employees, you should still list the name(s) and their time on the project and then indicate "0" dollars. If the intramural partner plans to hire temporary personnel on contract, the salary costs as well as level of effort for those individuals should be detailed in the budget.

Please contact the Collaborative U01 team at with any questions.

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