III. Preparing a P50 Application

A.Submit grant applications on form PHS 398
P50 grant applications must be submitted on form PHS 398 http://grants.nih.gov/grants/funding/phs398/phs398.html using the application standard receipt dates. Please see http://grants.nih.gov/grants/funding/submissionschedule.htm i.e. January 25, May 25 and September 25 for new, renewal or resubmission.

These application guidelines are designed to supplement and be used in conjunction with the Instructions for PHS 398. Since the Form PHS 398 is designed primarily for the traditional research project grant (R01) application, several sections have to be expanded, so that the form can be used to provide the additional information needed for the P50 grant application. Page limitations stipulated in the Instructions for PHS 398 apply to each of the component subprojects within a Clinical Research Center Grant application.

Submit a signed original of the application, including the checklist and three signed photocopies in one package to:

Center for Scientific Review (CSR)
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

In addition to the copies submitted to CSR, send two copies and all appendix CDs, in one package, to:

Chief, Scientific Review Branch, NIDCD
6120 Executive Blvd, EPS – 400C, MSC 7180
Bethesda, MD 20892-7180 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20852 (for express/courier service; non-USPS service)

Instructions for completing PHS 398 (Revised 11/2007)

The PHS 398 application kit is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format.

B. References
Published manuscripts and/or abstracts that are publicly available in a free, online format may be referenced in the application. These publications may not be included in the appendix. URLs or NIH PubMed Central (PMC) submission identification numbers may be included along with the full reference in the Literature Cited section, the Progress Report Publication List section and/or the Biographical Sketch section. While there is no limit to the number of URLs or PMC submission identification numbers that can be cited, applicants should be both judicious and concise. The PD/PI is responsible for making sure that any links are functional.

C. Appendix
All paper PHS 398 applications submitted for May 25, 2008 and subsequent due dates must provide appendix material on CD only. Include five identical CDs in the same package sent with the application under separate cover to the Chief of Scientific Review at NIDCD. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html

Do not use the appendix to circumvent the page limitations of the research plan component. An application that does not observe the required page limitations may be delayed in the review process

D. Letter of Intent
Not Applicable

E. Research Grant Table of Contents (Form Page 3 PHS 398)
Prepare a detailed table of contents that will enable reviewers to find specific information readily. Present the subprojects first and the cores last. Identify each subproject by title, assign each subproject a number and each core a capital letter that reflects the order in which the subprojects and cores are presented in the application, and provide the name of the responsible investigator for each component. Number the pages consecutively. Indicate the beginning page numbers for each subproject, core, and their respective budgets.

F. Budget (Form Pages 4 and 5 PHS 398)
P50 grants are not one of the mechanisms included in NIH's Modular Grants initiative. A detailed budget must be provided.

Reproduce the standard budget forms, pages 4 and 5, as necessary to allow preparation of both a "Detailed Budget for First 12-Month Budget Period" and a "Budget for Entire Proposed Project Period" for a composite budget, each subproject, and each core. All budgets (composite, subproject, core, and consortium/contractual) will be in this one section, placed in the same order that the subproject and cores are listed in the table of contents, and paginated accordingly. The complete budget section should include the following:

Composite budget for first 12-month budget period. Refer to Section VIII, Illustration 1 of this document for a sample composite budget for the first 12-month period. The composite budget is presented on Form Page 4, PHS 398. For each of the applicable budget categories (PERSONNEL, CONSULTANT COSTS, EQUIPMENT, SUPPLIES, TRAVEL, PATIENT CARE COSTS, CONSORTIUM/CONTRACTUAL COSTS, AND OTHER EXPENSES), give the amount requested for each subproject and core and provide subtotals where appropriate, as illustrated. If contractual arrangements or "purchased services" involving other institutions or organizations are anticipated, as in Project 5 and Core B in the sample budget shown in Illustration 1, include both direct and indirect costs associated with such participation in the CONSORTIUM/CONTRACTUAL COSTS category, as shown.

Composite estimates for all years of support requested. Refer to Section VIII, Illustration 2 of this document for a sample future-years composite budget, and use Form Page 5, PHS 398. Use the example format to present these composite budget estimates by category for all years of support requested.

Person months distribution among subprojects: As an aid to reviewers, the information on the person month of personnel should be presented in tabular format, such as shown in Section VIII. Illustration 3.

Individual first and future years’ budget estimates. Use the standard budget forms contained on Form Pages 4 and 5 of the PHS 398 to present the first budget period and future years’ budgets for each subproject and core. Place these after the aforementioned pages (the two pages of composite budgets and the page that illustrates the person month distribution among subprojects and cores) in the order the subprojects and cores are presented in the table of contents and in the application. Where appropriate, provide subtotal costs for calculations that are not obvious, such as: 2 blood samples x 40 patients x 2 outpatient visits @ $20/sample = $3,200. Explain non-inflationary cost increases added in future years. Provide explicit explanations to justify individual personnel and each major item requested in each of the other categories. Include budget justifications on the appropriate budget page (Form Page 5 PHS 398) even though explanatory information may be provided, or seems apparent, in the text of the research subproject or core.

Beginning with the May 2008 submission, budgets for new P50 applications are limited to $1,500,000/year direct cost (DC), including consortium direct costs but excluding facilities and administrative consortium costs. Competing renewals (type 2) P50 grant applications may request budgets (DC) that are no greater than 10% above the budget (DC) of the last year of the existing grant. Annual budget increases should not exceed more than NIH allowances at the time of submission of the application. Salary levels in all years are limited to the NIH maximum rate, currently at $191,300 per year. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-035.html

G. Biographical Sketches (Form Page 6 PHS 398)
Prepare biographical sketches as described in PHS 398 application guidelines and place them, in alphabetical order, in one section immediately after the budget section. Biographical sketches are required for all professional personnel (including consultants) who participate in the research subprojects and cores. If the pertinent publications listed constitute only a portion of an investigator's published works, please indicate the total number of full-length refereed publications.

H. Research Support
To aid in the review of your application, a tabular presentation of research support (current and pending) for all named investigators presented, such as that shown in Section VIII. Illustration 4 is requested.

I. Resources and Environment (Form Page 8 PHS 398)
If necessary, use continuation pages to describe multiple facilities and to explain geographic relationships.

J.  Research Plan
The research plan should begin with a statement that provides an overview of the entire program and describes the central theme and goals of the Clinical Research Center (P50). Provide the rationale for the proposed research program. Explain the strategy for achieving the objective(s) of the overall program and how each subproject and core relate to that strategy.

The beginning of the research plan is the appropriate place to: indicate any prior collaborative arrangements between investigators in the group; emphasize the events that led to the current application; predict the anticipated advantages that would be gained by including the research in the proposed program; describe the overall theme of the center and how the subprojects are related to that theme; and, describe the multidisciplinary nature of the proposed research.

K. Organizational and Administrative Structure
Describe in detail the chain of responsibility for decision-making and administration, beginning with the principal investigator and including the investigators (key personnel) responsible for the research subprojects and cores. Indicate where, in the chain of responsibility, advisory groups of internal and (or) external consultants would be used, and describe their function. (Letters of agreement from consultants should be included in the application).

Specific managerial responsibilities: Indicate who would be responsible for assisting the Principal Investigator with the day-to-day administrative detail, research patient care, program coordination, and the planning and evaluation of the program.

Relation of the Clinical Research Center organization and administration to the applicant institution: Describe the relation between the proposed Clinical Research Center and other existing research, academic, and administrative units of the applicant institution, such as centers, institutes, departments, and central administration.

Consortium/contractual arrangements: If the proposed program includes requests for funds for research activities that involve institutions other than the applicant organization, the program is considered a consortium effort. Such cooperative activities may be included in a P50 application, but it is imperative that a consortium application be prepared so that the programmatic, fiscal, and administrative considerations are explained fully. Where pertinent, include a letter from each of the cooperating organizations that signifies their intent to participate and to provide the necessary resources proposed in the application.

Applications with Multiple PIs: When multiple PD/PIs are proposed, use the Face Page-Continued page to provide items 3a – 3h for all PD/PIs. NIH requires one PD/PI be designated as the “contact PD/PI” for all communications between the PD/PIs and the agency. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PD/PIs, but has no special roles or responsibilities within the project team beyond those mentioned above. The contact PD/PI may be changed during the project period. The contact PD/PI should be listed in block 3 of Form Page 1 (the Face Page), with all additional PD/PIs listed on Form Page 1-Continued. When inserting the name of the PD/PI in the header of each application page, use the name of the “Contact PD/PI, et al.” The contact PD/PI must be from the applicant organization if PD/PIs are from more than one institution.

All individuals designated as PD/PI must be registered in the eRA Commons and must be assigned the PD/PI role in that system (other roles will not give the PD/PI the appropriate access to the application records). Each PD/PI must include their respective eRA Commons ID in the eRA Commons User Name field.

All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed project. See the Multiple Principal Investigator webpage for further information: http://grants2.nih.gov/grants/multi_pi/

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled “Multiple PD/PI Leadership Plan” must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.

If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.

L. Summary Report of Progress
Renewal (formerly competing continuation) applications must include a progress report that highlights achievements of the overall Clinical Research Center since the last competitive review. A specific progress report is required for each subproject and core unit in its respective section of the application. The progress report must include the following information:

• a brief summary of major accomplishments that can be attributed to the grant and a brief explanation of how these accomplishments have contributed to further the stated objective(s) of the grant;
• a list of all publications and manuscripts accepted for publication that have resulted from the grant (do not list manuscripts submitted or in preparation);
• a list of any changes in the professional staffing since the last competitive review;
• a tabular list of subprojects and cores that have been discontinued, completed, or modified since the last competitive review, identified by number and title, with a brief explanation of the reasons for the changes; and
• a list of subprojects and cores in the ongoing program, with the amount of current funding for each and the requested funding for the first budget period of each subproject and core that would be continued.

M. Format for the Presentation of a Component Research Subproject
Describe each subproject in the same detail required for the traditional, individual research grant (R01) application so that the scientific merit can be judged on the basis of the written application alone. Keep in mind that the application will be reviewed by experts who will judge, collectively, all areas represented in the application but who may not be familiar, individually, with each area of research proposed. Therefore, the description of a subproject should be explicit enough to enable experts in related areas to understand the main thrust of the subproject and how the subproject relates to the main theme of the program.

Each component research subproject must begin with the standard printed Form Page 2 PHS 398, DESCRIPTION.

Title of project: Title and number each subproject so that it can be readily distinguished from other subprojects.

Names and titles of investigators: Provide the name, academic title, and department or organization of the principal investigators and all key personnel.

Research plan: Follow the instructions for "Section 2. RESEARCH PLAN" (Instructions PHS 398), for presentation of each research subproject.

N. Format for the Presentation of a Component Core
A "core" is defined as a resource for the program that provides centralized services to more than one research subproject. Actual research is not conducted in a core. The following information must be provided whether the proposed core is new or existing [e.g., as in the case of an institution with an existing Core Center (P30) grant that is appropriate to the P50 application].

Title of core: Title and assign an alphabetic designation to each core so that it can be readily distinguished from the subprojects.

Names and titles of investigators: Provide the name, academic title, and department or organization of the core leader and each participating investigator.

Description of core: Explain the function of the core as a resource for the P50. Describe the facilities, techniques, and professional skills that the core would provide. As justification for the core, indicate how and which specific subprojects would utilize the resources of the core. Estimate the percent time and effort that core personnel would allocate to individual subprojects.

Progress report: For a renewal or revisional application, summarize the utilization and value of each core during the preceding period of support.

O. Resubmission Application

When submitting a resubmission application, an Introduction section is required and should summarize any substantial additions, deletions, and changes made. Include responses to criticisms in the previous summary statement. Do not exceed 3 pages for the Introduction to the resubmission application; each subproject or core of a resubmission may also include an Introduction not to exceed three pages. Changes within the text of the research plan should be highlighted by vertical lines in the margin, bracketing, indenting, or changing of typeface. Incorporate in the progress report any work done since the prior version was submitted. A resubmission application will be returned if substantial changes are not clearly apparent.

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