This funding announcement for Opportunities for Collaborative Research at the NIH Clinical Center (U01) is intended to provide extramural (non-NIH) investigators a mechanism to establish collaborations with NIH intramural investigators and to take advantage of the unique research opportunities available at the NIH Clinical Center. Project budgets are limited to $500,000 a year in direct costs for a period of up to three years, and funds should be designated to support the project-related costs of the extramural principal investigator, the intramural principal investigator / co-investigator, and the Clinical Center. Applications are due March 20, 2013, and letters of intent, which are highly encouraged, are due 30 days in advance of the proposal deadline. More information on the application process, particularly as it involves budget formulation or the letters of support requirement, is included below.
U01 Budget Instructions
General budget instructions can be found in the Funding Opportunity Announcement in Section IV. Application and Submission Information. In regards to determining the Clinical Center costs, more information can be found below.
Types of Clinical Center costs which may be included
Inpatient services, outpatient and day hospital services, pharmaceuticals, specialized research services, and other additional costs incurred by the Clinical Center as a result of the proposed research project may be included. Resources required need to be determined before the research protocol can be approved by the Clinical Center.
How the Clinical Center costs are identified
The collaborating intramural PD/PI is responsible for coordination with the Clinical Center to assure that all NIH Clinical Center related costs are clearly identified and documented. NIH Clinical Center related costs should be identified in the Extramural Collaborations budget templates 
(58 KB), which provide specific instructions for completion.
Once the intramural investigator completes the Extramural Collaborations budget templates, he or she should send them to ClinicalCtrPartner@mail.nih.gov. The Clinical Center Partner team will work with the investigator to provide accurate Clinical Center costs based on the completed template. Note: Applicants should allow sufficient time to identify and calculate these costs.
Once the Clinical Center costs are known, the (extramural) applicant will enter this amount as a "subaward" budget in the budget section of the application, using "NIH Clinical Center Costs" as the descriptor, and attach appropriate justification and documentation, including any spreadsheets as appropriate.
U01 Letter of Support Instructions
Applications submitted in response to the FOA must include two letters of support:
- A letter from the Director of the NIH Clinical Center to confirm that the Clinical Center facilities will be able to accommodate the proposed research, and
- A letter from the respective NIH Institute/Center (IC) to confirm that the intramural scientist from the respective NIH IC will be able to collaborate on the project.
Both letters must be included in the "Letters of Support" attachment for the PHS 398 Research Plan. Applicants may send requests for Letters of Support to:
Note: Applicants should allow sufficient time for the request to be fulfilled.
A Note to Intramural Principal Investigators
If you intend to serve as a principal investigator (PI) on this U01, you will need to be registered as a PI in the eRA Commons. If you are not already registered, your IC's Signing Official (SO) or Accounts Administrator (AO) can register you as a PI by creating an account with the PI authority role. When a Signing Official creates an account for a PI, the PI will receive an email to go to eRA Commons to verify the PI's profile information. If you already have a Commons Profile, the Signing Official or Accounts Administrator can affiliate that profile with your IC.
If you need assistance identifying your institute's Signing Official or Accounts Administrator, you may contact the eRA Commons Help desk by phone at 1-866-504-9552 (toll-free), or by email at commons@od.nih.gov.
For more information
For more information on formulating the budget for Clinical Center costs, please contact the Clinical Center Partner team by email at ClinicalCtrPartner@mail.nih.gov or by phone at 301-496-4121.
For general U01 questions, such as intellectual property issues and identifying NIH partners, please refer to the Frequently Asked Questions on this website.
For all other issues, such as application submission on Grants.gov, grants management questions, or scientific/research questions, please see the agency contacts listed in the U01 in Section VII. Agency Contacts.
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