Program Project (P01) Policies and Guidelines

Policies

Review of P01 Applications

• Until further notice, all P01 applications (new, resubmitted, and renewal) except revisions (competing supplements) will be reviewed by teleconference.

These changes in review practice were instituted with applications intended for award in FY 2009. You may contact the Chief, Office of Scientific Review at NIA if you have any questions concerning this policy.

Cost Limits on P01 Applications

The National Institute on Aging (NIA) limits costs on Program Project (P01) applications (See: http://grants1.nih.gov/grants/guide/notice-files/NOT-AG-07-008.html). NIA accepts for review and funding consideration only new (Type 1) and competing renewal (Type 2) P01 applications with requested costs limited to no more than $1.5 million in direct costs in the first year (exclusive of facilities and administrative (F&A) costs on subcontracts). Budget increases in non-competing years will reflect NIH policy in effect for the year of the non-competing continuation and may be requested to reflect an anticipated inflationary 3% annual increase only.

As with all applications requiring more than $500,000 these requests should be submitted to NIA at least 6 weeks prior to the intended submission date (NOT-OD-02-004).

Guidelines on Application Submission

These instructions supplement but do not replace the Public Health Service Grant Application (revised PHS Form 398) instructions at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-028.html. Applicants are encouraged to refer to the PHS Form 398 periodically because the instructions are updated frequently. In addition to the instructions below, a sample format (see below and at the bottom of this page) is available that shows ways to organize and present the required information.

Following submission of the application the investigators need to visit the eRA commons website (https://commons.era.nih.gov/commons/) on a regular basis to obtain information regarding: the status/image of the grant application; meeting roster; review date; review outcome (score); Summary Statements and other related matters.

Eligibility

• Applications from domestic institutions are eligible to apply. Applications from foreign institutions are not eligible, but individual foreign subprojects within the P01 are acceptable.
• To be eligible for an award, a P01 must have a minimum of three fundable research projects (Note: Cores are NOT research projects) each grant year, including one for the principal investigator (PI).
• Cores must be justified in terms of the P01's needs. A core must serve more than one project. Each P01 must have an administrative core.
• Competing renewal applications must include progress reports that discuss research and core component accomplishments during the previous award period, regardless of whether the components are included in the renewal application.
• Once a P01 has been awarded, revisions (competing supplements) to expand the scope of awarded grants will be considered, but may not extend beyond the timeframe of the parent P01. Unscored or deleted projects cannot be submitted as revisions. A revision application will not be accepted until after the parent P01 application has been awarded.

Submission Dates

All P01 -- new, competing renewal, and resubmitted applications:

• January 25
• May 25

Revisions (Competing supplements) to active P01s may be submitted for any of the regular submission and review cycles in:

• January 25
• May 25
• September 25

P01 applications that do not follow the required format (Font, Page margins, Page limits etc) will be returned without scientific review.

When submitting the application, send the original and three copies to the Center for Scientific Review (see PHS Form 398 for address). Send two copies of the application and six copies of the appendix materials to:

Chief, Office of Scientific Review
National Institute on Aging
National Institutes of Health
7201 Wisconsin Avenue, Suite 2C-212
Bethesda, MD 20892 (For Fedex use, MD 20814)

NIH now requires that all appendix material be submitted on CDs. See: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.

Page Limitations

New and Competing Renewal ("A0") Applications

The 25-page limit cited in the PHS Form 398 instructions applies to each research project individually. Cores are limited to 10 pages for Sections 2 - 5. Provide an introduction -- not exceeding 10 pages -- of the P01 as a whole. Page limitations are strictly enforced in the interest of fairness to all applicants.

Resubmitted ("A1" or "A2") Applications

INTRODUCTION page limits that describes responses to criticisms and issues raised in the Summary Statement are as follows:

1. An introduction not exceeding three (3) pages as an addition to the 10 page Introduction to the P01 as a whole (10+3 for A1 or A2).
2. An introduction not exceeding three (3) pages for each Subproject of the resubmitted P01 Application (25+3 for A1 or A2).
3. An introduction not exceeding one (1) page for each core of the resubmitted P01 Application (10+1 for A1 or A2).

RESEARCH PLAN: The changes must be clearly marked by bracketing, indenting, or changing type font, unless the changes are so extensive that they include most of the text. This exception should be explained in the Introduction. Changes should not be underlined or shaded and should meet the 25-page limit.

Revision (supplemental) Applications

An introduction -- not exceeding three pages -- providing information relevant to the nature of the revision; its relation to the overall theme of the program project; and how it will influence the specific aims, research design, and methods of the funded award is required. Any budget changes for the remainder of the project period of the current grant should be discussed in the Budget Justification section. Resubmitted supplements should include another introduction describing responses to the previous review.

Organization of the Application

Follow the instructions of the PHS Form 398, with the following additions:

Section 1: Information for the Entire Application

Table of Contents

1. Use the sample format in Attachment 1 (MS Word, 33K), rather than Form Page 3, "Table of Contents" from PHS Form 398, which applies only to applications for single projects.
2. Number all pages consecutively. Because the first page of the application is the Title Page, begin the next page with the numeral "2." Do not use lettered numbers (e.g., 2A, 2B, etc.).

Appendices (To be submitted on CDs)

1. Identify appendix material by the PI's name, core or project name and number, and core or project leader's name.
2. Refer to restrictions on any material that may be included in appendices as outlined in the PHS Form 398 instructions.
3. Send appendix CDs to the Chief, OSR, NIA.

Budgets

1. Insert a table describing the "Consolidated Direct Costs for First Year of Requested Support," as shown in Attachment 3 (MS Excel, 16K).
2. Insert budgets for the first 12 months and for the entire proposed period for the overall program. List detailed budgets for individual research projects and cores with the corresponding project or core.
3. Justify all items carefully according to the PHS Form 398 form instructions. A complete budget for a consortium project is to be developed and identified as such. The period of support may not exceed 5 years.

Biographical Sketches

1. Follow the PHS Form 398 instructions.
2. Include sketches for all key personnel, and list them in alphabetical order. However, list the PI's/program director's biographical sketch first.
3. Insert a completed Table II to aid in the review of the application. See Attachment 4 (MS Excel, 16K): "Distribution of Professional Effort (Percent) on This Application."

Section 2: Summary Research Plan for Entire Application

Introduction to the Application (Specific Aims)

1. Summarize the research focus and long-term goals of the overall program.
2. Include the major approaches and studies involved in the application.
3. Discuss the relation of the program to other activities in the applicant's institution (e.g., other relevant research projects) and the extent of institutional, departmental, and interdepartmental cooperation.
4. Describe the administrative relationships of the proposed program to the institution.
5. Include issues relating to institutional commitment and settings.
6. Describe the mechanisms that will ensure the coherence of the project and maintain a multidisciplinary focus.
7. Summarize the major resources available to the entire research program and the environment in which it will be conducted.

If this is a resubmitted or revision application, include information relevant to the overall program. The introduction should contain sufficient information from the original grant application to allow evaluation of the proposed revision in relation to the goals of the original application and how it will integrate with goals of the parent application.

Background and Significance

Self-explanatory.

Preliminary Studies/Progress Report

For new applications:

Provide a summary of relevant prior publications and other accomplishments.

For competing renewals and revisions (supplements):

1. Provide a summary of accomplishments, publications, and any problems encountered with fulfilling the original specific aims.
2. Include a report covering expansion or contraction of the currently funded program, if applicable.
3. Failure to include an adequate progress report will result in deferral of the application.
4. For competing renewal applications only: justify any changes in research emphasis and level of requested funds, and discuss progress for all funded elements in the previous period, regardless if they will be continued in the new application.

Human Subjects

1. Describe the general principles and policies that will apply to human subjects.
2. List the components of the application that involve human subjects and page numbers for the relevant human subjects sections.

See PHS Form 398 instructions.

Women and Minorities

1. Describe the composition of the human subjects and the proactive plan to recruit women and minorities.
2. List the page numbers for the relevant Women and Minorities sections.

See PHS Form 398 instructions.

Vertebrate Animals

1. Describe the general principles and policies that will apply to vertebrate animals.
2. List the components in the application that involve vertebrate animals and page numbers for the relevant Vertebrate Animal sections.

Consortium/Contractual Arrangements

List all performance sites -- including the applicant institution and the collaborating institutions -- on page 2 of the P01 application.

See Detailed Budget Initial Period (Adobe PDF, 292K) of PHS Form 398 instructions.

Consultants

1. Summarize this information for all components of the program, and indicate the consultants by name.
2. Include biographical sketches and signed letters of agreement to serve. For new applications, advisory committee members should not be recruited until after the review is complete, but include criteria used to select advisors.
3. Identify consultants -- and their respective institutions -- currently employed or with whom prospective employment has already been discussed.

Use of Cores by Projects

Insert a completed Table III (see Attachment 5 (MS Excel, 15K): "Percent use of Each Core by Each Project First Year").

Section 3: Research Plans for Individual Projects and Cores

1. Present information for each component project and core according to the Table of Contents.
2. List the cores first, identifying multiple cores by consecutive letters (Core A, Core B, etc.) and titles (Administrative Core, Laboratory Animal Core, etc.).
3. List individual research projects in the application after the cores, and identify them with consecutive Arabic numbers (Project 1, Project 2, etc.).
4. For competing renewals and revisions (supplements), continue numbering components according to the system used in the previous application (e.g., a continuing project included in the previous application should have the same number as in the earlier application). Number the new project in sequence if a project is eliminated and another one is added.
5. Write the title following the PHS 398 instructions.
6. Include the project leader's name at the upper right-hand corner of each page under the PI's name.
7. Prepare each core or project as a separate section beginning on a new page of the application, and begin each with a title page (use the format of Attachment 2 (MS Word, 25K), not the face page of PHS Form 398) and a detailed first year and summary budget for all years. Number the pages consecutively.

NIH recently extended policies on sharing research resources to Sharing Model Organisms. NIH also has provided a Web site that provides frequently asked questions and other information about the policy. (See: http://grants.nih.gov/grants/policy/model_organism/index.htm).

Full information about this policy and other grant-related policies can be found in the PHS 398 form (revised 11/2007).

Review Criteria

In addition to the uniform NIH review criteria for all research grant applications, the following criteria will be considered:

• The scientific merit of the program as a whole.
• The scientific merit of each individual project; each project should be supportable on its own merit.
• The significance of the overall program goals and a well-defined central research focus.
• The coherence and multidisciplinary or multifaceted scope of the program, the coordination and interrelationships among the individual projects and cores, and their relationship to the central focus of the overall program.
• The qualifications, experience, and commitment of the investigators for the individual research projects or cores and their contribution to the research effort, including their ability to devote adequate time and effort. It is expected the project leader will commit a substantial amount of time and effort to the research.
• Accomplishments of the research to date (for renewal and supplemental grant applications).
• The intellectual and physical environment in which the research will be conducted, including the availability of space, equipment, and research subjects, if applicable, and the potential for interaction with scientists from other laboratories and institutions.
• The appropriateness of the administrative and organizational structure to attain the research aims.
• Arrangements for internal quality control of the research, allocation of funds, day-to-day management, internal communications and cooperation among the investigators, including those involving contractual agreements, etc.
• The institutional strength, stability, and commitment to research and to the proposed research program, including fiscal responsibility and management capability to help the PI and staff comply with PHS policy.
• The appropriateness of the period of support.
• Protection of human subjects, gender, and minority recruitment into clinical studies, adequate care and use of vertebrate animals, and biohazard issues.

The review group will use the above criteria to score each research project and core that has significant and substantial merit and a priority score for the overall program, unless it is not recommended for further consideration. The PI's inclusion of marginal projects in an application may affect reviewers' assessment of the overall merit of the proposed program. Therefore, the application should include only projects with individual significance, substantial merit, and contribution to the merit of the overall proposed program.

Complete list of Attachments for Program Project Applications

Attachment 1 (MS Word, 33K): Table of Contents

Attachment 2 (MS Word, 25K): Sample Title Page for Individual Core or Component

Attachment 3 (MS Excel, 16K): Consolidated direct costs for first year of support

Attachment 4 (MS Excel, 16K): Distribution of professional effort (%) on this application

Attachment 5 (MS Excel, 15K): Percentage use of each core by each project in the first year.