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Last Updated: 01/24/23

Program Project (P01) Grant Development Guidance for Investigators Interested in DCTD Research Areas

Program Focus

This guidance is developed to support P01 program investigators interested in the Division of Cancer Treatment and Diagnosis (DCTD) research areas to navigate through the pre-application development process. DCTD supports broad areas of cancer research in its program portfolio. Please use this link to visit DCTD programs: NCI Division of Cancer Treatment and Diagnosis (DCTD) to find an appropriate program.

General Features of Program Project Grant

The P01 application process is complex with multiple components and projects packaged in one application. While each project can stand on its own scientific merit, the projects must complement one another. These components are building blocks of the overall enterprise to support a common theme or scientific objective rather than stand-alone projects.

Each application must consist of at least three research projects, an Administrative Core and Research Support Cores, as needed. The projects must share a common central theme, focus, and/or overall objective. The P01 program supports broadly based, multidisciplinary, often long-term research programs with a specific major objective. The following are characteristics of P01s:

  • Involves organized efforts of relatively large groups, whose members conduct research projects designed to elucidate various aspects or components of the objective.
  • In contrast to the narrow plan of a traditional R01, a program project is directed toward a range of problems having a central research focus.
  • Each research project is usually under the leadership of an established investigator (Project Leader).
  • Individual projects should be 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.
  • In the context of a multi-project application, synergy entails enhancement of scientific knowledge, ideas, and outcomes obtained through cooperative interactions of the individual projects and cores.
  • Meritorious projects should demonstrate an essential element of unity and interdependence, i.e., a system of research activities and projects directed toward a well-defined research program goal.

Important Considerations

  • Submit NCI P01 applications through the NCI Program Project Applications funding announcement (PAR-20-077).
  • All P01 applications are required to submit an Awaiting Receipt of Application (ARA).
  • PIs (Principal Investigators) submitting a new P01 application or PIs planning a renewal/continuation of an existing P01 are strongly encouraged to schedule a Pre-submission meeting with the program of interest.

Pre-Submission Meeting and Items to Submit

The purpose of the pre-submission meeting is to discuss the P01 idea and for NCI staff to provide feedback on the proposal, aspects that might raise concern with reviewers, and common flaws in P01 applications.

It is recommended that the applicant schedule a meeting with NCI program staff 3-7 months prior to the anticipated receipt date (Standard Receipt Dates: Jan 25, May 25, and Sept 25). The following items should be submitted 10 working days prior to the pre-submission meeting:

  • A 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 e-mails
    • Investigators' history of working together
  • Proposed Budget: Sub-total direct cost and direct cost per year in a separate budget page.
  • Target submission date.

Participants of the Pre-Submission Meeting

This will include the investigators, DCTD program staff, and a representative from the NCI's Division of Extramural Activities (DEA).

Budget and ARA Submission

  • Budgets for P01 program grants should be under $2 million direct cost per year regardless of the merit of the grant application or the budget justification. Detail is available on the DCTD's website funding page.
  • 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 Awaiting Receipt of Applications (ARAs) 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 visit Guidance for the Submission of an ARA here.

Summary of P01 Application Timeline for Investigators

It is recommended to 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 3-7 months prior to receipt date
Pre-submission Documents Required Submits Awaiting Receipt of Application (ARA) request (required for direct costs ≥$500,000) to the assigned/contact DCTD Program Director At least 8 weeks prior to application receipt date
  NCI/DCTD staff reviews ARA for approval 2-3 weeks after submitting ARA
  Submit Letter of Intent (LOI) to the NCI Referral Office using the guidance provided under LOI At least 30 days prior to application receipt date
Application Submission Submit P01 application as instructed in the active NCI Program Project Applications funding announcement (PAR-20-077) Standard Receipt Dates

Letter of Intent (LOI)

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC (Institute Center) staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information (PAR-20-077), prospective applicants are asked to submit a letter of intent, at least 30 days prior to the application receipt date, that includes the following information:

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

The letter of intent should be sent to:
Referral Officer
National Cancer Institute (NCI)
Telephone: 240-276-6390

Program Deliverables

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

  • Discuss budget restrictions and the ARA (Awaiting Receipt of Applications) submission process. The ARA should be submitted by the assigned Program Director upon receiving required documents from the PI.
  • A pre-submission meeting should be scheduled 3-7 months prior to the anticipated receipt date.
  • Program staff will review pre-submission material and the budget summary submitted by the PI prior to the meeting and provide feedback at the pre-submission meeting.
  • There will be Q&A session, and NCI staff may suggest ways to improve the procedural part of the application.
  • It should be noted that the feedback provided at this meeting does not constitute a formal NCI review and any recommendations should be taken as suggestions by the PIs. It is up to the investigators to determine which suggestion(s) to incorporate into their application.

Application Preparation

The page limit and details for preparing an application can be found in the NCI Program Project Applications funding announcement (PAR-20-077). The SF-424 application guide must be followed for preparing and submitting applications.

Application Receipt Dates

Please visit the following link for P01 application due dates.

Point of Contact

Dr. Aniruddha Ganguly (Cancer Diagnosis Program, DCTD),