III. Preparation of P01 Grant Application

A. Form

The PHS 398 form is available online and must be used for submitting a project application. P01 applications are submitted on paper.

B. Instructions

The following instructions modify and expand sections of the PHS 398 form that are specific to NCCAM CERC applications. These instructions are meant to be used with the PHS 398 form instructions and the funding opportunity announcement for NCCAM CERC (P01) grants.

1. Face Page, Page 1: For Box 2, check “Yes” and include the number “PAR-12-151” and title “NCCAM CERC Applications (P01).”
2. Table of Contents: Use the format as described in Illustration 1.
3. Summary Budget: Summary budgets are to be prepared as follows:
   1. For a first-year budget for the Center, use a summary format to show totals in each major category for each project and core (Illustration 2).
   2. For the “Budget for Entire Proposed Period of Support,” use the appropriate budget page of the PHS 398 form. The first year of support will reflect the category totals from the “Summary Budget for the Initial Budget Period” (Illustration 2). Omit budget justifications on this page, but include them with the individual project budgets.
   3. For a requested personnel table, list all key personnel and their annual effort (person months) including those for whom no salary is requested (Illustration 3).
4. Biosketches: The biosketch for the PI/PD is placed first and then biosketches for key personnel are placed in alphabetical order. Biosketches should only be placed here and not with the individual projects.
5. Overall Research Plan: Using continuation pages, substitute the following for the Research Strategy instructions of the PHS 398 form. For new applications, the overall research plan consists of the overall research strategy that covers points a–d below (12-page limit). For resubmission applications, the overall research plan consists of an introduction (1-page limit) and the overall research strategy. For renewal applications, the overall research plan consists of the overall research strategy and includes a table or list of publications cited by the project during its previous funding period (no page limits).
   
   The overall research strategy includes:
   1. CERC Introduction and Statement of Objectives: Present the background, rationale, and hypothesis of the central scientific theme and the specific objectives that address questions based on this central theme. Explain the strategy for achieving the objectives of the overall CERC.
   2. Organization and Synergy of the CERC: Describe the relationships among the projects and cores and their contribution to the overall strategy. Describe the unique advantages that would be gained by the proposed CERC, the synergy among the projects, and the means by which the projects collectively will achieve the stated objectives of the proposed research. Describe how the CERC will be administered and how the PI/PD will provide oversight. For new (Type 1) applications, this section should indicate prior collaborative arrangements among investigators in the group. For renewal (Type 2) applications, additional items should be included.
   3. Institutional Environment and Resources: Briefly describe the features of the institutional environment that would facilitate effective implementation of the CERC. As appropriate, describe available resources, such as clinical and laboratory facilities, participating and affiliated units, patient populations, geographic distribution of space and personnel, and consultative resources. If the projects are not at the same location, describe the plans for communication and sharing of biologic material.
   4. Relation of the CERC Organization to the Applicant Institution: Describe the relationships among the proposed CERC and other existing research units at the applicant institution. List any NCCAM-supported center or major research project grants at the applicant institution and their relationships with the proposed CERC. Indicate if any of the proposed cores will utilize or expand cores already existing at the institution.
6. Research Projects: Use a separate PHS Form 398 for each project and follow the instructions, as modified below. Each project should begin with a cover page consisting of the project number, title, and names of the project leaders and key personnel. This should be followed by all the sections of the PHS 398 form with the exception that biosketches are omitted. Describe each project in the same detail and format as required for a regular research grant (R01) application so that the scientific merit can be judged on the basis of the written application. The page limits of an R01 application apply to the research projects (12 pages for the Research Strategy section). As described under “General Review Considerations,” impact scores will be assigned to individual research projects as well as to the CERC as a whole. Thus, the description of each project should be explicit enough to enable peer reviewers to understand and evaluate each project independently.
   
   If human subjects or vertebrate animals will be used in a project, the necessary information must be supplied with that project.
   
   Each project is expected to comply with resource-sharing plans (NIH Data Sharing, Sharing Model Organisms, and Genome-Wide Association Studies (GWAS)), as applicable. These resource-sharing plans can be included with the individual projects or with the overall research plan, if the resource sharing is the same across the projects.
   
   CERC applications do not utilize modular budgets. A detailed budget is required for the first year, and total budget numbers are required for all subsequent years of support. Explicit and detailed budget justifications must be included for all years. For example, all personnel positions, regardless of whether dollars are requested, must be clearly justified. All listed individuals must have a specified time commitment.
7. Cores: Use a separate PHS Form 398 and follow the instructions except as noted here. The cover page should include the core number, title, and names of the project leader and key personnel. Provide a detailed budget for each core in the same way as for each project. Include the distribution of core costs among the projects as shown in Illustration 4. Cores should provide services to at least two research projects.
   
   In the core research strategy, describe the core and the various services it would provide, as well as the personnel, facilities, management, and any special arrangements such as cooperation with other established cores. The core research strategy should also include a clear delineation of procedures, techniques, and quality control and how core usage would be prioritized. If applicable, describe statistical analyses and data management in detail.
   
   Provide necessary information on usage of human subjects and vertebrate animals and inclusion of gender and minorities in human research, as appropriate.
   
   The core description and specific aims are limited to 1 page each and the core research strategy to 6 pages.
   
   Administrative cores will not be allowed.
8. Appendix: List all appendix material to accompany the application on the Table of Contents and follow the instructions for the PHS 398 form. Up to three publications per project or core of the types listed in the PHS 398 form instructions are allowed: grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.
   
   Do not use the appendix to circumvent page limits. Send all appendices (five CDs) to Chief, Review Branch, NCCAM, with two copies of the application.