Awaiting Receipt of Applications (ARAs) for Large Budget Grant Applications

For grant applications with subtotal direct costs greater than or equal to $500,000 in any one year, the National Cancer Institute (NCI) and the National Institutes of Health (NIH) require investigators to seek approval from the appropriate extramural program prior to submitting a grant application. Approval for applications assigned to the NCI's Division of Cancer Treatment and Diagnosis must be sought in the form of an Awaiting Receipt of Application (ARA) at least six weeks prior to submission.

Failure to seek approval prior to submission will result in the application not being accepted for review, and a delay in consideration until the next application receipt date. This policy applies to new (Type 1), competing renewal (Type 2), competing revision (Type 3), and amended/resubmitted applications (A1). The policy does not apply to applications submitted in response to Requests for Applications (RFAs) or other funding opportunities with specified budget limits, such as the SPORE Program.

Unanticipated requests for unusually high amounts of direct costs, for example, Program Project (P01s) grants with budgets over $2 million direct, are difficult for NIH Institutes and Centers to manage regardless of the merit of the grant application or the budget justification. ARAs help the NCI consider research projects with large awards as early as possible in the budget and program planning process. Investigators are encouraged to contact DCTD staff as early as possible to obtain further assistance in submitting an ARA.

Materials Required for ARAs

To request approval for an ARA, submit the following materials to the appropriate DCTD Program Director at least 6 weeks prior to the anticipated receipt date:

1. A letter requesting approval to submit a grant application to CSR in which the subtotal direct costs equal or exceed $500,000 in any year. The letter should also include the following details:
   • Grant application title. If the ARA is for a resubmission, please include the grant number.
   • Funding Opportunity Announcement (FOA). Please include the FOA number.
   • Scientific Impact. Brief discussion of why the grant application is unique and/or scientifically original, and the potential impact on the related field of research.
   • Budget. Subtotal direct costs, total direct costs, and total costs for each year.
     Tip: Do not include subcontract facilities and administrative (F&A) expenses in the subtotal direct cost calculations for the ARA. View the NIH policy on applications that include consortium and contractual facilities and administrative costs.
   • Budget Categories. In the spreadsheet provided (XLSX, 16 KB), indicate the costs for those budget categories that are driving the budget over $500,000 (or over $2,000,000 for P01s).
2. Draft budget pages with budget justification.
   1. It is not necessary to have institutional sign-off at this point.
   2. For Competing Renewals (Type 2), NCI policy limits (to 10%) the increase in first-year direct costs that may be requested in any competing renewal R01, U01, or P01 application over the award amount in the last year of the prior project period (i.e., over the last non-competing continuation award)
3. Abstract and specific aims, and study timeline, preferably in a Microsoft Word format.
4. If the grant application is a resubmission, include brief responses to the more significant reviewer concerns; however, it is not necessary to provide responses to all reviewer concerns.
5. Data sharing plan. All investigator-initiated applications with direct costs greater than or equal to $500,000 in any single year will be expected to address data sharing in their application (see NOT-OD-03-032 for the full NIH Statement on Sharing Research Data). The NIH expects and supports the timely release and sharing of final research data from NIH-supported studies for use by other researchers. (Note: NIH's definition of "timely release and sharing" is no later than the acceptance for publication of the main findings from the final data set.)
   At a minimum, the data sharing plan should include:
   • type of data that will be shared; please include data dictionary with information describing the variables that will be shared
   • the data repository to which the data will be submitted
   • the timeline for the data to be shared
   NCI's acceptance of the grantee's submitted or negotiated sharing plan will be incorporated as a term and condition of the award.