Guidance for the Submission of an Awaiting Receipt of Application (ARA)

Required for Unsolicited Large Grant Applications
(≥$500K or more direct costs, in any single year of the grant)

Requirements

For grant applications (e.g., R01, U01, or P01) with direct costs of $500,000 or more in any one year (regardless of the average per 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 an application. (See the NIH Guide for Grants and Contracts Notices NOT-CA-02-029 and NOT-OD-02-004.)

*First-tier consortium and administrative (F&A) costs do not count against the direct cost limit.

Failure to seek approval prior to submission will result in the application not being considered for review, or a possible delay in consideration until the next application receipt date. This policy applies to:

• New (Type 1)
• Competing renewal (Type 2)
• Competing revision (Type 3)
• Amended or resubmitted applications (A1)

The policy does not apply to SBIR (R43/R44), STTR (R41/R42), applications submitted in response to Requests for Applications (RFAs), Program Announcements (PARs), or other funding opportunities with specified budget limits.

ARA approval is limited to the permission to submit the application to NCI for initial peer review. Pre-approval of any large application for review does not commit the NCI or NIH to fund the application should it receive a favorable score.

Deadline for Submitting the ARA to the Division of Cancer Prevention

Investigators with grant applications fitting the above criteria must seek approval and are expected to submit an Awaiting Receipt of Application (ARA) at least six weeks prior to submission of the grant application.

The 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 the appropriate DCP Program Officer as early as possible in order to obtain further assistance in submitting an ARA. If an individual in DCP has not been identified, the investigators should contact the scientific contact for the FOA to which the grant will be submitted.

Although approval of the ARA is required prior to application submission, the investigators should continue to prepare the application for submission during the ARA review process while awaiting notification about approval.

Materials Required for the ARA

Investigators are encouraged to contact the appropriate DCP Program Officer to discuss the following requirements and be prepared to submit all materials at least 6 weeks in advance of the anticipated application receipt date.

(1) Letter of Intent (LOI)

The purpose of the LOI is to request approval to submit a grant application to the NCI Division of Extramural Activities (DEA) (or the NIH Center for Scientific Review) in which the subtotal direct costs equal or exceed $500,000 in any one year of the grant.

The letter should include the following details:

• Title of the Grant Application
  • Important: Keep the title exactly the same for actual application submission
  • If the ARA is for a resubmission, please include the grant number
     
• Key Personnel: The eRA Commons userid must be included for the PI or contact PI
   
• Anticipated Application Receipt Date
   
• Funding Opportunity Announcement Number
   
• Scientific Impact: Briefly discuss why the grant application is innovative or scientifically original, and the potential impact on the related field of research
   
• Estimated Budget: Subtotal direct costs, total direct costs, and total costs for each year
  • Do not include subcontract facilities and administrative (F&A) expenses in the subtotal direct cost calculations in the ARA material
  • See NIH Policy NOT-OD-05-004
     
• Budget Categories: Indicate the costs for those budget categories that are driving the budget to be $500,000 or more in any one year of the duration of the project
   
• Date of Programmatic Consult Meeting: The meeting should take place with DCP Program Officer several weeks prior to receipt date

(2) Draft Budget Pages with Budget Justification

• At the time of submitting the ARA, it is not necessary to have institutional sign-off.
   
• Type 2 Direct Cost Cap Policy
  • Per NOT-CA-08-026, the NCI has a specific policy limiting the amount requested for the direct cost budget for a renewal application. The direct cost budget request for the first Type 2 year generally cannot exceed an increase of 10% over the direct cost budget awarded for the last year of the prior project period (i.e., the last Type 5 award). This dollar cap for the direct cost increase is exclusive of any consortium or sub-contractual component of Facilities and Administrative (F&A) costs that may appear as direct cost in the budget of the applicant organization. In general, a Type-2 request less than the policy level will be awarded at the requested level
     
  • The policy applies to all Type 2 R01, U01 and P01 renewal applications regardless of the amount of the budget request or the budget format (modular or non-modular). Any deviation or alternative calculation requires prior approval from the NCI/DCP Program Officer and Grants Management Specialist at least six weeks prior to submission of the renewal application.
     
• For Program Project Grants (P01s), provide a budget summary for Projects and Cores.

(3) Abstract and Specific Aims

Ideally, this information should be provided as a separate document in Microsoft Word or PDF format.

(4) For a Grant Application Resubmission

Include brief responses to the more significant reviewer concerns; it is not necessary to provide responses to all reviewer concerns. Note that approval of the ARA for a first submission does not apply to or guarantee approval for a resubmission.

(5) For Clinical Trials

Include a description of the recruitment plan which may include enrollment rate, potential recruitment delays or challenges, retention plan, evidence for feasibility of enrollment, strategies to ensure the study population has scientifically appropriate diversity, and decision points for terminating the trial. See guidelines for recruitment planning.

Pre-Submission Consultation

For unsolicited R01 applications proposing subtotal direct costs of $500,000 or more in any one year, investigators are encouraged to discuss their application in a pre-submission consultation with DCP staff. The meeting may be held by teleconference, videoconference, or in person. To schedule this meeting, investigators are encouraged to contact the appropriate DCP Program Officer several weeks in advance of the anticipated receipt date.

The purpose of the pre-submission meeting is to provide feedback to the investigators on the proposed aims and scope of the application, alignment of the budget with infrastructure needs, and resource/data sharing plan. Please note that feedback provided are suggestions; this pre-submission meeting does not constitute a formal NCI review.

Relevant NIH and NCI Policies

• NOT-CA-02-029, Clarification of the NCI Policy on Acceptance for Review of Unsolicited Applications that Request $500,000 or More Direct Costs Per Year (Released September 27, 2002)
   
• NOT-OD-02-004, Revised Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs (Released October 6, 2001)
   
• NOT-OD-05-004, Applications that Include Consortium/Contractual Facilities and Administrative Costs (Released November 2, 2004)
   
• NOT-CA-08-026, Change in Allowable Budget Levels of Renewal (Type 2) R01, U01, and P01 Applications for the National Cancer Institute (Released August 15, 2008)
   
• NOT-CA-04-004, NCI Policy on Unsolicited R01 Applications that Request $700,000 or More Direct Costs Per Year (Released February 10, 2004)
   
• NOT-OD-03-032, Final NIH Statement on Sharing Research Data (Released February 26, 2003)
   
• NOT-OD-21-013, Final NIH Policy for Data Management and Sharing (Released October 29, 2020, Effective Date: January 25, 2023)