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 (e.g., Division of Cancer Control and Population Sciences [DCCPS]) prior to submitting an application. In particular, if you are planning to submit a request with subtotal direct costs above $700,000 in any year, please consult the appropriate DCCPS staff before developing specific budget pages and justifications. Approval for applications assigned to NCI’s DCCPS must be sought in the form of an Awaiting Receipt of Application (ARA) at least 8 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.
Unanticipated requests for unusually high amounts of direct costs are difficult for NIH institutes and centers to manage regardless of the merit of the grant application or the budget justification. ARAs help NCI consider research projects with large awards as early as possible in the budget and program planning process. Investigators are encouraged to contact DCCPS staff as early as possible in order to obtain further assistance in submitting an ARA.
|Required ARA Information
|Details to Include in ARA Request
|Links to Related NIH Policies and Other Notes
|Letter requesting approval to submit a grant application to NIH’s Center for Scientific Review (CSR) in which the subtotal direct costs equal or exceed $500,000 in any year.
|To view the NIH policy on applications that include consortium and contractual facilities and administrative costs, see NOT-OD-05-004.
|Draft budget pages with budget justification
Requesting and justifying costs for data management and sharing
To request funds toward data management and sharing costs, investigators should include
|It is not necessary to have institutional sign-off at this point.
For competing renewals (Type 2), NCI policy limits the increase in first-year direct costs that may be requested in any competing renewal (Type 2) R01, U01, or P01 application to 10% over the award amount in the last year of the prior project period (i.e., over the last non-competing continuation award).
For more details about allowable budget levels for NCI renewal, see NOT-CA-08-026. For more details about allowable costs for data management and sharing, see NOT-OD-21-015.
|Abstract, specific aims, and study timeline
|Ideally, this information will be provided as a separate Microsoft Word document.
|Data management and sharing plan
|The principal investigator and institution are expected to
program director to obtain a data management and sharing plan template.
The data management and sharing plan will need to address the following elements:
Contact your assigned
Please note that any information or descriptions related to biospecimen management and sharing should be included in the resource sharing plan section of the grant application. It should not be included in the data management and sharing plan.
|All investigator-initiated applications conducting research that generates scientific data, regardless of budget, will be expected to include a data management and sharing plan to comply with the NIH 2023 Data Management and Sharing Policy (NOT-OD-21-013).
Data management and sharing plans may be further negotiated and considered as part of the funding decision. Applications will only be funded when data management and sharing plans are complete and accepted by NIH program staff. See NOT-OD-21-014 for information about the elements of an NIH data management and sharing plan.
All NIH-funded research that generates large-scale human or non-human genomic data is also subject to the NIH GDS Policy (NOT-OD-14-124). Thresholds for projects that fall within the scope of the GDS Policy are available on the NCI Genomic Data Sharing webpage.
When both the data management and sharing and GDS policies apply, only one plan that addresses both policies should be submitted. Note that GDS Policy expectations remain in place regarding data to be submitted, repository and timelines for data submission and release, and informed consent and institutional certification. See NOT-OD-22-198 for more details on harmonization of the data management and sharing and GDS policies.
Some funding opportunity announcements have specific data sharing expectations.
See also NIH information on preparing data management and sharing plans.
Deadlines for Submitting ARAs
The NIH Guide for Grants and Contracts’ Notices NOT-CA-02-029 and NOT-OD-02-004 state that approval must be sought 6 weeks prior to submitting such applications. However, as mentioned in the “Requirements” section above, approval for applications assigned to NCI’s DCCPS must be sought in most cases at least 8 weeks prior to submission to CSR or NCI in order to complete the necessary internal processing. The only exception is the February 5 receipt deadline, in which we encourage a 10-week deadline to ensure adequate time for processing the request.
Program directors will acknowledge receipt of an ARA request within 2 business days of receiving the request. If an investigator has not received a notice of receipt, they should verify receipt of the ARA by emailing the program director.
See below to learn more about grant application due dates by mechanism for cycles I, II, and III for most applicants, the alternate submission schedule for members of chartered NIH Study Sections and selected other advisory groups, and notes for new investigators.
NIH has an alternate schedule for submission and review of large-budget R01, R21, and R34 (including AIDS-related) grant applications received from members of chartered NIH Study Sections and selected other advisory groups in recognition of their outstanding service to NIH.
Eligible investigators are appointed members of chartered standing NIH Study Sections, Boards of Scientific Counselors, Advisory Boards or Councils, the Peer Review Advisory Committee, and peer reviewers who have served as regular or temporary members 6 times in 18 months.
The schedule, described below, permits periods of continuous submission so that applications may be submitted as soon as they are completed. Applications are reviewed no later than 120 days after receipt. To enable timely second-level review, the following National Cancer Advisory Board (NCAB) dates will apply. If time permits, applications may be moved to earlier NCAB dates following review.
Investigators who intend to submit a large R01 application under the continuous submission policy will be required to submit their ARA 8 weeks prior to the anticipated submission date.
|Submission Period for Continuous Submission
|August 11–December 10
|December 11–April 10
|April 11–August 10
The following table lists the grant application due dates for CSR by grant mechanism, followed by the dates by which your program director must receive ARAs for that cycle. If the due date falls on a weekend or holiday, then the deadline is the next business day.
Be aware that approval given to submit a large-budget application is limited to the cycle (CSR receipt date) for which the proposal is being submitted.
|Research grants – R01 and U01 – new
|ARA deadline for DCCPS
|Research grants – R01 and U01 – renewal, resubmission, revision
|ARA deadline for DCCPS
|Program project grants and center grants – P series new, renewal, resubmission, revision
|ARA deadline for DCCPS
|New investigator – R01 resubmissions (optional submission dates)
|ARA deadline for DCCPS
|All mechanisms cited above (new, renewal, resubmission, revision) for AIDS and AIDS-related applications
|ARA deadline for DCCPS
Reminders for Competing Renewals (Type 2)
In 2008, NCI changed its funding policy for all competing renewal (Type 2) applications to cap first-year direct costs so that they generally do not exceed an increase of 10% over the direct costs awarded for the last year of the prior project period (i.e., the last Type 5 award). See the NIH Guide Notice, NOT-CA-08-026, and contact your program director for more information.
FAQs about ARAs
Yes. You must always submit an ARA when your application’s subtotal direct costs equal or exceed $500,000 in any year.
Approval of your ARA is required prior to submission. However, you should continue to prepare the application for submission during the ARA review process.
Relevant factors include alignment with priority research areas, novelty and complementary nature of the research, reasonableness of the budget, and the proposed data sharing plans.
The investigator is expected to comply with the budget that was approved in the ARA request. However, decreases in direct costs are permitted without further NCI approval. If an increase in direct costs is anticipated, the investigator’s program director should be contacted to determine whether further approval is required.
For cancer-related grant applications in which the subtotal direct costs in any one year equal or exceed $500,000, investigators must seek approval from NCI prior to submitting applications to NIH’s CSR. The NIH Guide for Grants and Contracts’ Notices NOT-CA-02-029 and NOT-OD-02-004 state that approval must be sought 6 weeks prior to submitting such applications. However, approval for applications assigned to NCI’s DCCPS must be sought in the form of an ARA at least 8 weeks prior to submission to CSR or NCI in order to complete the necessary internal processing.
Please contact a program director to discuss budget constraints for submitting R01 and P01 applications to DCCPS.
A denial means that a grant application will not be accepted as proposed. There could be a variety of reasons for a denial of the ARA, and investigators should consult with the program director for advice and what next steps may be appropriate.