Process for Submitting Large Budget Cancer Epidemiology Grant Applications ( ≥ $500,000)

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Investigators are encouraged to contact the appropriate EGRP Program Directors (PD) as early as possible in order to obtain assistance in submitting ARAs. Those who do not already have an assigned PD are invited to review the EGRP staff list to identify PDs with related scientific interests.

Requirements

Investigators planning to submit a grant application to the National Cancer Institute (NCI) in which the subtotal direct costs in any one year equal or exceed $500,000, must seek approval from NCI prior to submitting applications to NIH’s Center for Scientific Review (CSR).

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.

Why Do Investigators Need to Obtain Approval to Submit an Application with Large Budgets?

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 budgets as early as possible in the budget and program planning process.

When Does this Policy Apply?

This policy applies to:

  • New (Type 1) applications,
  • 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.

Consequences Associated with Not Obtaining Approval

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.

Materials Required for ARAs

To request approval for an ARA, submit the following materials to the EGRP Program Director, copying the EGRP central ARA inbox (NCIDCCPSEGRPARARequests@mail.nih.gov) at least 8 weeks prior to the anticipated receipt date.

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 in which the subtotal direct costs equal or exceed $500,000 in any year.
  • Grant application title. If the ARA is for a resubmission, please include the grant number.
  • Funding Opportunity Announcement (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. Do not include subcontract facilities and administrative (F&A) expenses in the subtotal direct cost calculations for the ARA.
  • 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.
 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
  • Draft budget pages and budget justification are required from the parent site and subaward sites.
  • Budget Categories. In the spreadsheet provided [XLSX - 11KB], please indicate the total costs by budget category.
  • For Program Project (P01s), please provide a budget summary [XLSX - 26KB] for the Projects and Cores
 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 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 and P01 applications, see NOT-CA-08-026.
Research plan Abstract and specific aims, and study timeline Ideally, this information will be provided as a separate Microsoft Word document.
Data sharing plan The Principal Investigator and institution are expected to:
  • Affirm their intention to share the research data consistent with all relevant NIH resource/data sharing policies.
  • State whether they may need to request an exception to any NIH resource/data sharing policy, and the rationale for the request.
  • State that they understand that detailed resource sharing plans may be requested after peer review, but before funding decisions are made.

The data sharing plan should include information addressing expectations of the all relevant resource sharing policies. At a minimum, it should include:

  • Statement of all NIH resource sharing policies relevant to the proposed grant application.
  • Extent and type of data that will be shared.
  • Data repository to which the data will be submitted.
  • Timeline for the data to be shared.

Resource sharing plans may be further negotiated and considered as part of the funding decision.

All investigator-initiated applications with direct costs $500,000 or more in any single year will be expected to include a data sharing plan in their application to comply with the NIH 2003 Data Sharing Policy (NOT-OD-03-032).

View additional details

All NIH-funded research that generates large-scale human or non-human genomic data is also subject to the NIH Genomic Data Sharing (GDS) Policy (NOT-OD-14-124). Examples of projects that fall within the scope of the GDS Policy are available on the NCI Genomic Data Sharing webpage.

View additional details

Please note that the timeline for sharing data under the GDS policy differs from the 2003 data sharing policy.  The GDS policy requires that data be shared once it has been cleaned (e.g., the analytic dataset is finalized).  The 2003 data sharing policy requires that the data be shared no later than the acceptance for publication of the main findings from the final dataset.

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 six weeks prior to submitting such applications. However, as mentioned in the “Requirements” section above, approval for applications assigned to the Epidemiology and Genomics Research Program (EGRP) in NCI’s Division of Cancer Control and Population Sciences must be sought at least eight weeks prior to submission to CSR or NCI in order to complete the necessary internal processing.

See below to learn more about EGRP’s grant application due dates by mechanism for cycles I, II, 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.

Members of NIH Study Section, 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 investigators 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 11 – December 10
October December 11 – April 10
January April 11 – August 10

See the NIH Guide Notice, NOT-OD-20-060.

All Other 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 27-Nov 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) 10-Apr 10-Aug 10-Dec
ARA Deadline for EGRP 13-Feb 15-Jun 15-Oct
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

Pre-Submission Guidelines for PAR-20-294 (Core Infrastructure Support for Cancer Epidemiology Cohorts)

In addition to the ARA package for all applications in excess of $500,000 in direct costs, applicants requesting $700,000 or more in direct costs in any year to PAR-20-294 (Core Infrastructure Support for Cancer Epidemiology Cohorts) will be required to participate in a pre-submission consultation meeting with EGRP/NCI program staff. This pre-submission meeting should be scheduled via teleconference, videoconference, or in person at least 12 weeks prior to 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.

Requirements

  • ARA Package
  • A table summarizing recruitment, follow-up, and attrition: Include initial enrollment (by 5 year age groups) and current age structure; vital status (alive, deceased, lost-to-follow-up); response rates to most recent questionnaire and/or follow-up by age group. For cohorts actively recruiting, include enrollment in prior funding, target enrollment and timeline to complete recruitment in the upcoming cycle.
  • A table summarizing the investigators who have used the cohort data/resources during the current funding period indicating whether project is led by investigators within or outside of the Cohort Investigator team, as well as projects led by early stage investigators.
  • List of ancillary grants (from all funding sources) that have supported and/or leveraged resources from the cohort for research-related activities in the past five years should be included as an attachment.

Applicants should contact Joanne Elena at Joanne.Elena@nih.gov for further details and coordination.

Timeline for Submissions to PAR-20-924

When planning to submit to PAR PAR-20-294, please consider the following overall timeline:

Topic Action Timetable
Pre-submission Meeting Investigator works with program staff to set up a meeting to be held at least 12 weeks before receipt date. Approximately 3 months before receipt date
Investigator sends EGRP Program Director 5-page proposal including information specified above. 2 weeks prior to pre-submission meeting
NCI Program Director provides the investigator with a summary of the meeting discussions. 1 to 2 weeks after the pre-submission meeting
Pre-submission Documents Investigator submits Awaiting Receipt of Application (ARA) request (required for direct costs ≥ $500,000) to the assigned EGRP Program Director. At least 8 weeks prior to application receipt date
NCI staff reviews ARA for approval purposes. 3-4 weeks after submission of ARA
Submission Investigator submits the application per the instructions in the active NCI Program Project Applications funding announcement (PAR-20-294). November 12, 2020; April 9, 2021; November 9, 021; April 7, 2022; November 9, 2022

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

If I am submitting an amended application and my original application had an ARA that was approved, do I need to submit another ARA?

Yes. You must always submit an ARA when your application’s subtotal direct costs equal or exceed $500,000 in any year.

Should I wait to hear if my ARA has been approved before moving forward with submitting my application?

Approval of your ARA is required prior to submission. However, you should continue to prepare the application for submission during the ARA review process.

Once the ARA is approved, does NCI allow changes to the budget?

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.

How do I know if I need to seek prior approval before submitting my large-budget grant application?

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 six weeks prior to submitting such applications. However, approval for applications assigned to NCI's DCCPS, of which EGRP is a part, must be sought in the form of an ARA at least eight weeks prior to submission to CSR or NCI in order to complete the necessary internal processing.

Is there a limit on the total costs that I can request for each year?

There is no official budget cap for ARAs submitted to NCI/DCCPS. While the proposed science should drive the budget, investigators should be cognizant that NCI has a limited pool of funds for large budget applications, such as large R01s (direct costs of $700K or more in any year) and P01s. DCCPS lists the recently awarded R01 and P01 applications on the Division website. This information can be used as a guide when determining the budget for your ARA.

Relevant NIH 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 (Release date: September 27, 2002)
  • NOT-02-004, Revised Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs (Release date: October 6, 2001)
  • NOT-CA-08-026, Change in Allowable Budget Levels of Renewal (Type 2) R01, U01, and P01 Applications for the National Cancer Institute (Release date: August 15, 2008)
  • NOT-OD-03-032, Final NIH Statement on Sharing Research Data (Release date: February 26, 2003)
  • NOT-OD-14-124, NIH Genomic Data Sharing Policy (Release date: August 27, 2014)
  • NOT-OD-20-060, Update of NIH Continuous Submission Policy: Change in Submission Deadlines and End of Recent Substantial Service Option (Release date: January 24, 2020)
  • NOT-OD-19-053, NIH Policy for Review and Resubmission of New Investigator R01 Applications (Release date: January 7, 2019)
Last Updated: 21 Aug, 2020