REVISED POLICY ON THE ACCEPTANCE FOR REVIEW OF UNSOLICITED APPLICATIONS THAT REQUEST $500,000 OR MORE IN DIRECT COSTS Release Date: October 6, 2001 NOTICE: NOT-OD-02-004 October 6, 2016 - See Notice NOT-OD-17-005 August 10, 2011 - See Notice NOT-NS-11-023. Improving the Quality of NINDS-Supported Preclinical and Clinical Research through Rigorous Study Design and Transparent Reporting. March 7, 2011 - See Notice NOT-OD-11-049 Notice of Budget Update for PA-11-063. January 4, 2011 - See Notice NOT-EB-11-002 Notice of Update for New Biomedical Frontiers at the Interface of the Life and Physical Sciences (R01). July 29, 2010 - See Notice NOT-DK-10-011 Change of Application Budget Limit for NIDDK PAR-08-182. (NICHD Policy and procedures, see NOT-HD-06-003) (Also see policy revision NOT-NS-06-004 and also NOT-OD-04-040) National Institutes of Health The National Institutes of Health (NIH) is updating 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. BACKGROUND The NIH supports research projects with large budgets but needs to consider such awards as early as possible in the budget and program planning process. Regardless of the merit of the application or the budget justification, unanticipated requests for unusually high amounts of direct costs are difficult for NIH to manage. It is in the best interest of all parties if applicants anticipating large direct costs to contact the appropriate NIH program staff as early as possible to ensure that an Institute/Center would be willing to accept the application. This notice clarifies and revises the policy published in the NIH Guide for Grants and Contracts on March 20, 1998. The current policy advises an applicant planning to submit an investigator-initiated new, competing continuation, competing supplement, or any amended/revised version of the original application requesting $500,000 or more in direct costs for any year to contact Institute or Center program staff before submitting the application. Discussions with program staff should occur as plans for the study are being developed. However, that notice does not specify a timeframe for this process. This revised policy requires applicants to seek agreement 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. PROCEDURES An applicant planning to submit a grant application with $500,000 or more in direct costs for any year is required to contact in writing or by telephone NIH Institute or Center program staff. This contact should be made during the development process of the application but no later than 6 weeks before the anticipated submission date. If the Institute or Center is willing to accept assignment of the application for consideration of funding, the staff will notify the Center for Scientific Review before the application is submitted. The Principal Investigator must include a cover letter with the application. That cover letter must identify the program staff member and Institute or Center that has agreed to accept assignment of the application. 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. INQUIRIES For additional information about this policy, the program staff at any Institute or Center may be contacted. Applicants who are uncertain about which Institute or Center may have the greatest interest in the research for which support is sought should contact: Division of Receipt and Referral Center for Scientific Review National institutes of Health Telephone: (301) 435-0715 FAX: (301) 480-1987
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