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Last Updated: 06/06/24

Program Project (P01) Grant Development Guidance for Investigators Interested in the Division of Cancer Treatment and Diagnosis (DCTD) Research Areas

Background

The goal of this guidance is to help investigators navigate through the P01 (Program Project Grant) pre-application process in the cancer research areas that DCTD supports including the Cancer Diagnosis Program (CDP). Please use this link, NCI Division of Cancer Treatment and Diagnosis (DCTD), to visit DCTD programs to find an appropriate program contact relevant to your research interest.

General Features of the P01 Grant

P01s support broadly based, multidisciplinary, often long-term research programs with a specific major objective. The P01 contains multiple components and projects packaged in one application, consisting of:

  • Research projects (a minimum of 3) that share a central theme, focus, and/or overall objective
  • An Administrative Core
  • Research Support Cores (as needed)

While each project can stand on its own scientific merit, they must complement or interact with one another. These projects are the building blocks of a highly integrated grant and support a common theme or scientific objective rather than the individual components.

In addition, P01s have the following features:

  • Involve organized efforts of relatively large groups, whose members conduct research projects designed to:
    • elucidate various aspects or components of the objective
    • advance the field
  • Directed toward a range of problems having a central focus (in contrast to the narrow plan of a traditional R01).
  • Usually have an established investigator (Project Leader) to lead each research project.
  • Have individual projects that are clearly interrelated and synergistic (inform the other) so that the research ideas, efforts, and outcomes of the program will collectively offer a distinct advantage over pursuing individual projects separately.

P01 Application Preparation and Important Considerations

  • The page limit and details for preparing P01 applications are found in the NCI Program Project Applications funding announcement (PAR-23-059).
  • Investigators should:
    • Submit P01 applications through the NCI Program Project Applications funding announcement (PAR-23-059).
    • Submit an Awaiting Receipt of Application (ARA), (required for all P01 applications).
    • Follow the SF-424 application guide.
    • Schedule a pre-submission meeting with the DCTD program of interest (strongly encouraged for principal investigators (PIs) submitting a new P01 application or planning a renewal/continuation of an existing P01).

Pre-Submission Meeting and Items to Submit

DCTD recommends that applicants schedule a pre-submission meeting with NCI Program staff 3-6 months prior to the anticipated receipt date (Jan 25, May 25, and Sept 25; see Standard Receipt Dates).

Purpose

  • Discuss the P01 idea
  • Receive feedback from NCI staff on the structure of the proposal, aspects that might raise concern with reviewers, and common flaws in P01 applications

    **NCI staff will not suggest specific experiments or guide the research in any way. **

Participants:

  • Investigators
  • DCTD program staff
  • Representative from the NCI’s Division of Extramural Activities (DEA)

Items to Submit (10 working days prior to the pre-submission meeting)

  • Brief executive summary (4-5 pages max) of the overall program that includes:
    • Planned coordination and collaboration reflecting interaction and synergy, and hypothesis
    • How the P01 Project will be integrated to enable sharing of data and results across projects for greater productivity and scientific progress
    • Abstracts and Specific Aims of each project
    • A short description of each core with role(s)
    • Investigators’ names, affiliations, and emails
    • Investigators’ history of working together
  • Proposed Budget: Sub-total of direct cost and indirect cost per year in a separate budget page
  • Target submission date

Budget and Awaiting Receipt of Application (ARA) Submission

  • Budgets for P01s should be under $2.0 million direct cost per year regardless of the merit of the grant application or the budget justification. More details are available on DCTD’s website funding page.
  • For Competing Renewals (Type 2), NCI policy limits to 10% increase in first-year direct costs that may be requested over the award amount in the last year of the prior project period (i.e., over the last non-competing continuation award).
  • Approval for applications assigned to DCTD must be sought in the form of an ARA at least eight weeks prior to submission. ARAs help NCI consider research projects with large awards as early as possible in the budget and program planning process. Please review the Guidance for the Submission of an ARA.

P01 Application Timeline for Investigators

DCTD recommends investigators consider the following timeline for preparing and submitting a P01 application.

Preparation Phases Action Timetable
Pre-submission Meeting Investigator works with DCTD program staff to set up a meeting 3-6 months prior to receipt date
Pre-submission Documents Required Investigator submits Awaiting Receipt of Application (ARA) request (required for direct costs ≥ $500,000) to the assigned/contact At least 8 weeks prior to application receipt date
  NCI/DCTD staff reviews ARA for approval 2-3 weeks after investigator submits ARA
  Investigator submits Letter of Intent (LOI) to the NCI Referral Office using the guidance provided under LOI below At least 30 days prior to application receipt date
Application Submission Investigator submits P01 application as instructed in the active NCI Program Project Applications funding announcement (PAR-23-059) Standard Receipt Dates

Letter of Intent (LOI)

Although an LOI is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIH IC (Institutes and Centers) staff to estimate the potential review workload and plan the review.

DCTD requests prospective applicants to submit an LOI at least 30 days prior to the application receipt date. Refer to Part 1. Overview Information of PAR-23-059. The LOI should include the following:

  • Descriptive title of proposed activity
  • Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
  • Name(s) of other key personnel
  • Participating institution(s)
  • Number and title of this funding opportunity

Send the LOI to:
Referral Officer
National Cancer Institute (NCI)
Telephone: 240-276-6390
Email: ncirefof@dea.nci.nih.gov

Program Deliverables

NCI staff will support P01 investigators by providing guidance on the pre-application development process as follows:

  • Discuss budget restrictions and the ARA submission process; upon receipt of the PI’s documents, the assigned Program Director will submit the ARA to the DCTD Office of the Director
  • Schedule a pre-submission meeting 3-6 months prior to the anticipated receipt date
  • Review pre-submission material and the PI’s budget summary prior to the meeting and provide feedback at the pre-submission meeting
  • Suggest ways to improve the procedural part of the application during the Q&A session at the pre-submission meeting

NOTE

Feedback provided to the investigators at this meeting does not constitute a formal NCI review, and the PI should consider any recommendations to be suggestions. The investigators determine which suggestion(s) to incorporate into their application.

Point of Contact:

Dr. Aniruddha Ganguly (Cancer Diagnosis Program, DCTD): gangulya@mail.nih.gov