Large Budget Grant Applications ( ≥ $500,000)


Purpose

For grant applications in which the subtotal direct costs in any one year equal or exceed $500,000, the National Cancer Institute (NCI) and the National Institutes of Health (NIH) require investigators to seek approval from the appropriate extramural program staff member prior to submitting applications to NIH’s Center for Scientific Review (CSR). The NIH Guide for Grants and Contracts’ Notices NOT-CA-02-029External Web Site Policy and NOT-OD-02-004External Web Site Policy state that approval must be sought six weeks prior to submitting such applications. However, approval for applications assigned to NCI’s Division of Cancer Control and Population Sciences (DCCPS), of which the Epidemiology and Genomics Research Program (EGRP) is a part, must be sought in the form of an Awaiting Receipt of Application (ARA) at least eight weeks prior to submission to CSR or NCI in order to complete the necessary internal processing.

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 (formerly called “competing continuation” applications) (Type 2), competing revision (formerly called a competing supplement) (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 the NIH extramural Divisions, such as DCCPS, consider research projects with large awards as early as possible in the budget and program planning process. Investigators are encouraged to contact the appropriate EGRP Program Directors as early as possible in order to obtain assistance in submitting ARAs.

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Materials Required for ARAs

To request approval for an ARA, submit the following materials to the EGRP Program Director at least 8 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:
    1. Grant application title. If the ARA is for a resubmission, please include the grant number.
    2. Funding Opportunity Announcement (FOA). Please include the FOA number.
    3. 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.
    4. Budget. Subtotal 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 costsExternal Web Site Policy.
    5. Cost-Reduction Measures. Explanation of why the subtotal direct costs per year equal or exceed $500,000, and what cost-reduction measures are being applied to the proposed study (e.g., how you are trying to maximize the cost-effectiveness of the research).
  2. Draft budget pages with budget justification. Note:
    1. The PHS398 or SF424 budget page template should be used. View NIH forms and applicationsExternal Web Site Policy.
      NOTE: Subtotal direct costs, total direct costs and total costs are required for all years proposed.
    2. If you expect that the subtotal direct costs will exceed $2.5M in any year (for R01 and U01 applications), please let your EGRP Program Director know immediately, as he/she will need to request additional levels of NCI approval. Additional levels of approval are required for P01 applications in which the subtotal direct costs exceed $6.0M in any year.
    3. It is not necessary to have institutional sign-off at this point.
    4. 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)External Web Site Policy.
  3. Abstract and specific aims, 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. For genome-wide association studies and whole genome/exome sequencing studies, please provide a draft data sharing plan.

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Deadlines for Submitting ARAs

Most Applicants

The following table lists the grant application due dates for CSR by grant mechanism, followed by the dates by which EGRP must receive ARAs for that cycle. If the EGRP 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.

Grant Mechanism: Cycle I Cycle II Cycle III
Research Grants - R01 AND U01 - new 5-Feb 5-Jun 5-Oct
ARA Deadline for EGRP 12-Dec 10-Apr 10-Aug
Research Grants - R01 AND U01 - renewal, resubmission, revision 5-Mar 5-Jul 5-Nov
ARA Deadline for EGRP 9-Jan 10-May 10-Sept
Program Project Grants and Center Grants - P Series new, renewal, resubmission, revision* 25-Jan 25-May 25-Sept
ARA Deadline for EGRP 30-Nov 30-Mar 31-July
New Investigator - R01 resubmissions (optional submission dates) 20-Mar 20-July 20-Nov
ARA Deadline for EGRP 24-Jan 25-May 25-Sept
All Mechanisms Cited Above (new, renewal, resubmission, revision) for AIDS and AIDS-Related Applications 7-May 7-Sept 7-Jan
ARA Deadline for EGRP 12-Mar 13-July 12-Nov

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NIH Study Section Members, Boards/Councils

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 are appointed members of chartered standing NIH Study Sections, Boards of Scientific Counselors, Advisory Boards or Councils, the Peer Review Advisory Committee (PRAC), and peer reviewers who have served as regular or temporary members six 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 RO1 application under the continuous submission policy will be required to submit their ARA eight weeks prior to the anticipated submission date.

NCAB Round Submission Period for Continuous Submission
May August 17 – December 16
October December 17 – April 16
January April 17 – August 16

See the NIH Guide Notice, NOT-OD-14-028External Web Site Policy.

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New Investigators

New Investigators who submit an amended application under the policyExternal Web Site Policy to shorten the review cycle for New Investigator R01s may not have sufficient time between when the summary statement is released and the next application receipt date to meet the required eight week submission deadline for an ARA. Nevertheless, an ARA is still required if the subtotal direct costs are equal to or exceed $500,000 in any year.

Be aware that:

  • Participating Study Sections will schedule meetings so that New Investigators receive their summary statements no later than March 1, July 1, or November 1.
  • Resubmission applications for consideration at the next cycle must be submitted by March 20, July 20, or November 20
  • In cases where this is a short time period between receipt of the summary statement and the CSR application receipt due date, the investigator should contact Program staff to discuss a suitable deadline for submission of the ARA. See the NIH Guide Notice, NOT-OD-07-083External Web Site Policy.

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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-08-026External Web Site Policy, and contact your Program Director for more information.

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FAQs about ARAs

  1. Q: If I am submitting an amended application and my original application had an ARA that was approved, do I need to submit another ARA?
    A. Yes. You must always submit an ARA when your application’s subtotal direct costs equal or exceed $500,000.
  2. Q: Should I wait to hear if my ARA has been approved before moving forward with submitting my application?
    A: Approval of your ARA is required prior to submission. However, you should continue to prepare the application for submission during the ARA review process.
  3. Q: Once the ARA is approved, does NCI allow changes to the budget?
    A: 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.

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