For all original new (i.e., never submitted) and competing renewal applications submitted for the January 25, 2009 due date and beyond, NIH will accept only a single amendment (A1) to the application (called a “resubmission” application). A lengthy hiatus after the initial submission may be marked by significant advances in the scientific field and the comments of the reviewers may no longer be relevant. Therefore, a resubmission application must be submitted within 37 months after the date of receipt ("receipt date") of the initial New, Renewal, or revision application (see NOT-OD-10-140). After 37 months, you may submit a New application. Any second resubmission will be administratively withdrawn and not accepted for review.
For original new and competing renewal applications submitted prior to January 25, 2009, applicants are permitted two resubmissions (A1 and A2). For these “grandfathered” applications, any second resubmission (A2) must be submitted no later than the appropriate due date for Cycle III; NIH will not accept any A2 resubmissions after that date. This resubmission policy applies to all NIH extramural applications. Refer to NOT-OD-10-080 for details concerning applicants eligible for continuous submission for R01, R21, and R34 whose original new or competing renewal application was submitted prior to January 25, 2009.
See NOT-OD-07-083 for special conditions and due dates for new investigator resubmission applications submitted for consecutive review cycles. Note this applies only to new investigator R01s submitted for standard receipt dates and reviewed in recurring study sections in CSR, and selected other study sections only (e.g., NOT-MH-08-002).
In the referral process, NIH staff look at all aspects of the application, not just the title and description (abstract). Requesting review by a different review committee does not affect the implementation of this policy. When necessary, previous applications are analyzed for similarities to the present one. Thus, identical applications or those with only minor changes will not be accepted for review.
1.4 Policy on the Acceptance for Review of Unsolicited Applications That Request $500,000 or More in Direct Costs
Applicants must seek agreement to accept assignment from Institute/Center staff at least six weeks prior to the anticipated submission of any application requesting $500,000 or more in direct costs for any year. For the purposes of this policy, the $500,000 limit excludes any consortium F&A costs.
See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html and http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-040.html.
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 contact the appropriate NIH program staff as early as possible to ensure that an Institute/Center (IC) would be willing to accept the application. If staff is contacted less than six 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 prior acceptance policy does not apply to applications submitted in response to RFAs or in response to other Announcements that include specific budgetary limits. Such applications must be responsive to any budgetary limits specified; however, any specified budgetary limit excludes consortium F&A costs.
An applicant planning to submit a grant application with $500,000 or more in direct costs for any year (excluding consortium F&A costs) is required to contact in writing or by telephone NIH IC program staff. This contact should be made during the development process of the application but no later than six weeks before the anticipated submission date. If the IC 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 PD/PI must include a cover letter with the application. That cover letter must identify the program staff member contacted and the Institute/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 not be reviewed. Therefore, NIH strongly encourages applicants to contact appropriate IC staff at the earliest possible time.
For additional information about this policy, contact the program staff at any Institute/Center. Applicants who are uncertain about which IC may have the greatest interest in the research for which support is sought should contact the NIH CSR Receipt and Referral Office at (301) 435-0715.
SBIR/STTR applicants are NOT required to obtain pre-approval to submit an application if the budget exceeds $500K in direct costs per year. The $500K Policy does not apply to applications submitted in response to RFAs or other solicited applications, and SBIR/STTRs are solicited applications. In addition, the budget levels set for SBIR/STTRs are statutory guidelines, not caps.
However, SBIR/STTR applicants are strongly encouraged to contact Institute/Center Program Staff before submitting an application in which the budget and/or project period deviates from the statutory guidelines. While the Phase I and Phase II award levels are guidelines that allow for applicants to propose a budget and project period appropriate for completion of the research project, deviations from the guidelines should be discussed with appropriate NIH staff listed in the Awarding Component/Agency Contact Information Table prior to submission of the application.