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NIDDK Program Project (P01) Guidelines

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Forward

It is a pleasure to provide the research community served by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) the revised Administrative and Review Guidelines for the Program Project Grant Application of the NIDDK. These Guidelines supersede all previous guidelines, and they include recent changes in PHS Form 398 (Rev. 11/07) and in NIH policy. The Guidelines are written to serve applicants, members of peer review groups, and NIDDK staff.

These changes to the Guidelines will take effect immediately and apply to program project applications submitted for January 25, 2010 and later application receipt dates:

• As part of the NIH's ongoing process of enhancing peer review, applications are being shortened and restructured (NOT-OD-09-149). In order to be compliant with these new guidelines, applicants will now be limited to 12 pages per project and 6 pages per core.
• The principal investigator for the overall program project must request support entailing sufficient effort to provide effective oversight of the P01. Only one amended application will be accepted for P01 submissions.The maximum dollar request for new NIDDK program project applications remains subject to a limit of $5 million in direct costs over 5 years and the absolute budget cap on direct costs for renewal applications remains $6.25 million (NOT-DK-05-006).
• Any application that does not adhere to the page limits outlined in this document will be returned without review. Additionally, these Guidelines apply to all submissions targeting the January 25, 2010 due date and beyond, and cannot be circumvented by sending in an application earlier than the submission date.

As with any large grant application, potential applicants are encouraged to contact NIDDK program staff early in the planning process for P01 applications. At a minimum, applicants must: 1) contact NIDDK program staff at least 6 weeks before submitting the application; 2) obtain agreement from NIDDK staff that NIDDK will accept the application; and 3) include a cover letter with the application identifying the NIDDK staff member who agreed to accept the application ( http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html ). As each programmatic division has specific submission requirements, very early contact (up to one year before submission of an application) is strongly recommended.

The transition to electronic submission of P01 applications is currently on hold. More information regarding electronic receipt is available at: http://era.nih.gov/ElectronicReceipt/

Dr. Griffin Rodgers
Director, NIDDK

Table of Contents

______________________________________________________________________

1. Description of the Program Project Grant
   
   
2. Pre-Application Procedures
   1. Assignment
   2. Communication with NIDDK Staff
      
      
3. Preparation of P01 Grant Application
   1. Form
   2. Instructions
      1. Face Page (Page 1)
      2. Program Project Description, Performance Sites, and Key Personnel
      3. Table of Contents
      4. Composite Budget
   3. Biographical Sketches
   4. Current Sources of Support
   5. Overall Research Plan
   6. Research Projects
   7. Core Units
   8. Checklist
   9. Appendix
      
      
4. Additional Instructions for Competing Continuation Applications
   1. Budget Caps
   2. Application
   3. Progress Report
      
      
5. Additional Instructions for Competing Supplement Applications
   
   
6. Additional Instructions for Revised Applications
   
   
7. Receipt Dates and Copy Requirements
   
   
8. Reporting Requirements and Annual Evaluation
   
   
9. Review Guidelines
   1. General Review Considerations
   2. Review of Individual Projects
   3. Review of Individual Cores
   4. Review of Overall Program Project
   5. Administrative Considerations
   6. Final Recommendation
      

Illustration 1 - NIDDK Program Project Grant Application Table of Contents

Illustration 2 - Detailed Budget Page for Initial 12-Month Period

Illustration 3 - Composite Budget for Budget Period

Illustration 4 - Requested Personnel

Illustration 5 - Distribution of Core Unit Costs

Illustration 6 - Publications Citing Support from this Program Project Grant

Illustration 7 - Relationship Between Parent Grant and Supplemental Request

I. Description of the Program Project Grant

A program project (P01) award is for the support of a broadly based multidisciplinary or multifaceted research program which has a well-defined major objective or central theme. It is directed toward a range of scientific questions having a central research focus in contrast to the more narrow thrust of the traditional research project (R01). The program project should reflect the organized efforts of investigators who are conducting research designed to elucidate the various aspects or components of the central theme. Each research project is usually under the leadership of a different experienced investigator and should contribute to the common theme of the overall program. Collectively, these projects should demonstrate essential elements of unity and interdependence and result in a greater contribution to program goals than would occur if each project were pursued individually. It is expected that most of the collaborating scientists will be independent investigators. Thus, support of one senior investigator and several postdoctoral or research associate-level scientists as project leaders is not appropriate. The program project grant is not intended to be a vehicle for departmental research support. In most cases, several departments should be represented.

An investigator may submit a project as an R01 application and as part of the program project for review in the same review cycle. If such a project receives an independently derived priority/impact score/percentile ranking which merits funding of both applications, funding of the project in the program project will take precedence over the R01 application, and the latter will be inactivated administratively.

In addition to the support of research projects, the program project may provide funds for support of common resources and facilities (cores) that would be available for use by the project investigators.. Cores should provide some service, techniques, determination, or instrumentation that will enhance the research endeavors, consolidate manpower effort, and contribute to cost effectiveness and quality. Core support may include personnel, equipment, supplies, services, and facilities required for conducting the studies proposed in the projects. It is expected that a core must provide essential functions or services to at least two priority-scored research projects.

The size of a program project is an important consideration. Program projects that are too large may suffer from lack of communication and interaction among the participants. On the other hand, smaller program projects may suffer from lack of a "critical mass" of investigators and would best be suitable for support using the R01 mechanism. In attempting to deal with these issues, the NIDDK has adopted the following policies:

1. New (Type 1) program project applications cannot request more than $5 million (direct cost) over 5 years (note exclusion of subcontract indirect costs below). .
2. Renewal (Type 2) program project applications have an absolute cap of $6.25 million in direct costs requested for 5 years ( with the exclusion of subcontract indirect costs; see below). Effective with the June 1, 2005 receipt date, Type 2 applications were no longer be subject to the previously established 20% cap on budget escalation.
3. Exceptions to the caps will apply to program project grant applications that include subcontracts. In such cases, the indirect costs related to the subcontracts will be excluded from the requested direct cost levels prior to application of the cap. This exclusion of subcontract indirect costs applies to the $5 million cap for new applications and the absolute cap of $6.25 million for renewal applications.
4. Noncompeting years will be held to a 3 percent or biomedical research index amount (whichever is less) increase over the preceding year, adjusted for expansions or contractions of effort or scope as recommended by peer review, until the absolute cap is reached.
5. Competing revisions (formerly supplements) will be accepted only for the continuation of projects that were originally funded for a time period shorter than the overall program project. The revision (supplemental) request may be up to 3 percent above the previous year's support for that project(s).

The basic criteria for classification as a program project are:

1. A clearly defined, unifying central theme to which each project relates and to which each investigator contributes.
2. A minimum of three research projects that are judged to have significant scientific merit, as well as being complementary or contributory to the central theme of the program project and recommended for the duration of the program, which is usually five years.
3. The participation of experts in several disciplines or in several areas of one discipline. All investigators must contribute to, and share in, the responsibilities of fulfilling the program objective.
4. A principal investigator/program director who is an established research scientist and who has the experience, ability, and time commitment to ensure quality control and to effectively administer and integrate all components of the program. The program project mechanism does not at this time use the multiple-PI option (http://grants.nih.gov/grants/multi_pi/index.htm). The administrative structure should be individualized to meet the needs of the program project. However, the use of an internal advisory committee selected from the participating investigators and/or an external advisory committee of outside consultants is encouraged. New applications should not name the potential external advisory committee members, as this would effectively bans them from being part of the review panel. The application should only describe the mechanism by which the EAC members will be chosen.
5. The interrelationship of projects and collaboration of investigators that will yield synergy and results beyond those achievable were each project pursued independently.

II. Pre-Application Procedures

1. Assignment

   Applications submitted to the National Institutes of Health (NIH) are assigned to individual Institutes (e.g., NIDDK) after careful consideration of the overall scientific goals of the applications in relation to the missions of the Institutes. In general, the NIDDK accepts program project applications in all scientific areas relevant to its mission. In addition, the Center for Scientific Review (CSR), in consultation with Institute staff, makes the decision as to whether or not a given application fits the criteria of a program project. If the budget of any application is $500,000 or more per year, that application will be returned unless the Institute program staff have been contacted before submission and have agreed to its submission. Very early contact and a much longer lead time (up to one year before submission of an application) is recommended.

   Following consultation with NIDDK Program staff, it is strongly encouraged that potential applicants also submit a letter of intent. The letter should be sent at least 3 months prior to the application receipt date to allow NIDDK staff to identify potential opportunities and problems early in the development of the application.

   Letters of intent should be sent to:

   Chief, Review Branch
   Division of Extramural Activities
   National Institute of Diabetes and Digestive and Kidney Diseases
   Two Democracy Plaza , Room 752
   6707 Democracy Boulevard , MSC 5452
   Bethesda , MD 20892-5452
   For courier/express delivery, please use 20817 Zip code
   Phone: (301) 594-8897
   Fax: (301) 480-3505 or (301) 480-4126

   The letter of intent should include only (1) the names of the principal investigator/program director and principal collaborators; (2) descriptive title of the potential application; (3) identification of the organization(s) involved; and (4) announcement (if any) to which the potential application is responsive.

2. Communication with NIDDK Staff

   It is very important to establish communication between the potential applicant group and NIDDK program staff early in the process of P01 development. This interaction is not part of the peer review process. Although specific submission requirements vary among the programmatic divisions of NIDDK, all divisions recommend that potential applicants contact the appropriate program director as soon as possible; contacting NIDDK a full year before the anticipated submission date is strongly suggested. The appropriate NIDDK program director will discuss the following areas with the prospective principal investigator:

   1. Scientific Content and Objectives : It is important for the applicant to appreciate what areas of science are appropriate for NIDDK sponsorship. It is to the applicant's advantage to discuss scientific content and objectives of an application with the appropriate NIDDK staff member. For new applications, a pre-application meeting with NIDDK staff is encouraged. However, advice given by staff must not be interpreted as a commitment to make an award. The staff will not evaluate or discuss the merit of the scientific aspects of the application.
   2. Focus : The size of the proposed program is an important item for discussion.
   3. Organization : The NIDDK staff may assist the potential applicant by suggesting revisions in the organization of the proposed application to reflect better the program project concept. For example, appropriate use of core components and consultants may strengthen an application. Weaknesses in the organization and integration of the written application reflect poorly on both leadership and collaborative arrangements. It is essential to have a clear understanding of why the program project mechanism of support is more appropriate than a collection of individual research applications.
   4. Clarifications : Often problems are created when an application reflects a misunderstanding or misinterpretation of the program project guidelines. Therefore, clarifications should be obtained early in the process from NIDDK staff. It is, however, the applicant's responsibility to read and to follow carefully the directions for application submission as set forth in the PHS Form 398. An incomplete application may result in deferral of the application to a subsequent review cycle, or in the withdrawal of the application from review and return to the applicant.

III. Preparation of P01 Grant Application

1. Form

   The PHS Form 398 (Rev 11/07) is available only online and must be used for submitting a program project application. The original and three copies of the completed application should be mailed to the Center for Scientific Research; an address label is included in the PHS Form 398 application information. In addition, two copies of the application and all appendices (five CDs) should be sent directly to the Chief, Review Branch, NIDDK (same address as for the Letter of Intent, above).

2. Instructions

   The instructions provided below modify and expand appropriate sections of the PHS Form 398 to make it applicable for new or renewal program project applications. These instructions are meant to be used with the PHS Form 398 instructions. It is important to follow the PHS Form 398 instructions closely. For renewal, resubmission, and revision applications, reference should be made to additional instructions below in these P01 guidelines (Section IV, Section V, Section VI). For applications submitted in response to a Funding Opportunity Announcement (FOA), other instructions and requirements may apply.

   1. Face Page, Page 1 : Type "Program Project" on line 2 of the face page next to "Title." Complete all items on the face page as directed.
   2. Program Project Description, Performance Sites, and Key Personnel, Page 2 : Describe the proposed research program, indicating the major thrust of the component projects. List performance sites and complete the key professional personnel section.
   3. Table of Contents : The various sections of the Table of Contents for a program project grant application are described in Illustration 1 of this document.
   4. Composite Budget : New budget guidelines can be found at http://grants1.nih.gov/grants/guide/notice-files/NOT-DK-05-006.html . New (Type 1) program project applications cannot request more than $5 million (direct costs) over 5 years. An exception to the cap will apply to program project applications that include subcontracts. In such cases, the indirect costs related to the subcontracts will be excluded from the requested direct cost levels prior to application of the cap. Renewal (Type 2) applications may request budgets up to an absolute cap of $6.25 million in direct costs for 5 years. As noted above, CSR will return any application requesting more than $500,000 per year, unless the appropriate program staff have been contacted in advance and the Institute has agreed to the application's submission. A series of composite budgets (Illustrations appended) are to be prepared as follows:
      1. A first-year budget for the program project using the page of PHS Form 398 entitled "Detailed Budget for First 12-Month Budget Period" (Illustration 2).
      2. The "Budget for Entire Proposed Period of Support" using the appropriate budget page of PHS Form 398. The first year of support will reflect the category totals from Illustration 2 budget. Omit budget justifications on this page, but include them with the individual project budgets.
      3. A breakdown of the composite budget for each requested year as indicated in Illustration 3.
      4. A requested personnel table, listing all professional and nonprofessional participants in the program, including those for whom no salary is requested, according to the format in Illustration 4. Similarly, present the detailed information for the remaining categories as specified in the instruction sheets for PHS Form 398. Request of support for sufficient effort for the Principal Investigator/Program Director to provide effective oversight and administration of the P01 is a specific review criterion.
3. Biographical Sketches

   Updated biographical sketches are required for all professional personnel. These should be prepared in accordance with the directions for PHS Form 398 (Rev 11/07), arranged in alphabetical order, and placed at the end of the budget section of the application.

   The biographical sketch may not exceed four pages. Complete the educational block at the top of the format page, and complete sections A, B, C, and D.

   1. Section A. Personal statement. Briefly describe why your experience and qualifications make you particularly well-suited for your role (e.g., PD/PI, mentor, participating faculty) in the project that is the subject of the application.
   2. Section B. Positions and Honors. List in chronological order previous positions, concluding with the present position. List any honors. Include present membership on any Federal Government public advisory committee.
   3. Section C. Publications. NIH encourages applicants to limit the list of selected peer-reviewed publications or manuscripts in press to no more than 15. Do not include manuscripts submitted or in preparation. The individual may choose to include selected publications based on recency (5), importance to the field (5), and/or relevance to the proposed research (5). When citing articles that fall under the Public Access Policy, were authored or co-authored by the applicant and arose from NIH support, provide the NIH Manuscript Submission reference number (e.g., NIHMS97531) or the PubMed Central (PMC) reference number (e.g., PMCID234567) for each article. If the PMCID is not yet available because the Journal submits articles directly to PMC on behalf of their authors, indicate "PMC Journal - In Process." A list of these Journals is posted at: http://publicaccess.nih.gov/submit_process_journals.htm. Citations that are not covered by the Public Access Policy, but are publicly available in a free, online format may include URLs or PMCID numbers along with the full reference (note that copies of publicly available publications are not acceptable as appendix material.)
   4. Section D. Research Support. List both selected ongoing and completed research projects for the past three years (Federal or non-Federally-supported). Begin with the projects that are most relevant to the research proposed in the application. Briefly indicate the overall goals of the projects and responsibilities of the key person identified on the Biographical Sketch. Do not include number of person months or direct costs.
4. Overall Research Plan

Using continuation pages, substitute the following for the Research Plan instructions of PHS Form 398. The overall research plan should not exceed 12 pages:

1. Program Introduction and Statement of Objectives: Describe the rationale for the proposed research program. Explain the strategy for achieving the objective of the overall program, how each project and core unit relate to the strategy, and how the projects and cores relate to one another.
   
   It is important to indicate prior collaborative arrangements among investigators in the group, to emphasize the events that have led to the current application, to predict the anticipated unique advantages that would be gained by the research within the proposed program project, to describe how the projects are mutually complementary, and to explain how the projects collectively would achieve the stated objectives of the proposed research.
2. Institutional Environment and Resources : Briefly describe the features of the institutional environment that are or would be relevant to the effective implementation of the proposed program. 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.
3. Organizational and Administrative Structure of the Program Project : Describe in detail, and by diagram if appropriate, the chain of responsibility for decision-making and administration. Describe to whom the principal investigator/program director reports and the administrative structure as it relates to the individual project/core principal investigators.
   
   If advisory groups are included, indicate where in the chain of responsibility they fit, and describe the specific functions of these consultants in the overall program. Please do not include external advisory committee members’ names in new program project applications. For the EAC you should only describe the mechanism by which they will be chosen. For review purposes, it is best if they are not contacted until after the review and selection for funding.
4. Specific Managerial Responsibilities : Indicate who would be responsible for assisting the principal investigator/program director with the day-to-day administrative details, program coordination, and planning and evaluation of the program, and who would be in charge in the absence of the director.
5. Designation of Replacement for Principal Investigator : Describe procedures for appointing a replacement for the principal investigator if the need should arise.
6. Relation of the Program Project Organization and Administration to the Applicant Institution : Describe the relationships among the proposed program project and other existing research, academic, and administrative units of the applicant institution, such as centers, institutes, departments, and central administration. Indicate if any of the proposed cores will utilize or expand cores already existing at the institution.

E. Resource Sharing Plans - These plans are NOT included in the 12-page limit.
Data Sharing Plan : Investigators seeking $500,000 or more in direct costs in any year must include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss their data-sharing plan with their program contact at the time they negotiate an agreement with the Institute/Center (IC) staff to accept assignment of their application. http://grants.nih.gov/grants/policy/data_sharing/index.htm .

Sharing Model Organisms : Regardless of the amount requested, all applications where the development of model organisms is anticipated are to include a description of a specific plan for sharing and distributing unique model organism research resources or state appropriate reasons why such sharing is restricted or not possible. Note that unlike the data sharing requirement above, this requirement is for all applications where the development of model organisms is anticipated. See http://grants2.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html . If model organisms are not planned as part of the research proposal, omit this section.

Genome-Wide Association Studies (GWAS) : Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. GWAS is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.

F. Research Projects

Use a separate PHS Form 398 (minus the standard face page) for each project, and title and number each project sequentially so that it can be readily distinguished from other projects in the program. Each research project should be identified clearly by the same title as that provided in the Table of Contents.

Each project should begin with a face page consisting of the project number, title, and name of the project leader. This should be followed by the abstract, budget pages, and information requested in the instructions for PHS Form 398. Describe each in the same detail and format as required for a regular research grant application so that the scientific merit can be judged on the basis of the written application. For each project, adhere to the restrictions on number of pages and type size indicated in the instructions for PHS Form 398 and as modified in NOT-OD-09-149. The total number of pages for Sections 3-5 of the research plan for each individual project must not exceed 12 pages. Applications exceeding this page limitation will be returned to the applicant. As described under "General Review Considerations," priority scores will be assigned to individual research projects as well as to the program project as a whole. Thus, the description of each project should be explicit enough to enable peer reviewers to understand the main thrust of each project without resorting to appendix materials to provide detailed procedures or critical data. If human subjects or vertebrate animals will be used, the necessary information must be supplied , and the issue of inclusion women, minorities, and children must be addressed for each project and core, as outlined in PHS Form 398.

Modular budget does not apply to the program project grant application. The budget for each research project should adhere to the instructions from PHS Form 398. A detailed budget is required for the first year; budget estimates 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.

G. Cores

Use a separate PHS Form 398, and name and assign a letter designation to each Core. Provide a detailed budget for each core in the same way as for each project. 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 description of the core should not exceed 6 pages, excluding any human subjects and/or vertebrate animals section and Illustration 5.

The core description should include a clear delineation of procedures, techniques, and quality control, and how core usage would be prioritized. If applicable, describe in detail statistical analyses and data management. Provide necessary information of usage of human subjects and vertebrate animals and inclusion of gender and minorities in human research, as appropriate.

Within each core, indicate which core services each project would utilize. In addition, prepare a table that indicates the research projects each core would serve and the proportion of the cost of the core associated with each research project (see Illustration 5). Illustration 5 is not included in the page limits.

H. Checklist

See Sample Checklist Form in PHS Form 398.

I. Appendix

List all appendix material to accompany the application on the Table of Contents.

All appendix materials must now be provided on CDs only ( NOT-OD-08-031 ).

NOTE: Send all appendices (five copies) to Chief, Review Branch, NIDDK, with the two copies of the application (see below). Additional original glossy photographs or color images that do not reproduce well electronically should be sent only after the application has been assigned to a review group, in consultation with the Scientific Review Officer in charge.

IV. Additional Instructions for Renewal (Competing Continuation) Applications

1. Budget Caps

   In general, the size of funded program project grants will be limited by caps on the amounts that can be requested and by restricting the scientific scope of the grant.

   1. Renewal (Type 2) applications may request budgets up to the $6.25 million absolute cap.
   2. As a general rule, the Institute's goal will be to hold increases in renewal awards to an average of no more than the Biomedical Research and Development Price Index (BRDPI).
   3. The absolute cap of $6.25 million direct cost requested for 5 years will be maintained, including any requested escalation in future years.
   4. Noncompeting years will be held to a 3 percent increase over the preceding year, adjusted for expansions or contractions of effort or scope as recommended by peer review.
   5. Once a program project is funded, expanding its scientific scope - by expanding the number of scientific goals and objectives in a competing continuation application - will not be possible. This applies to all program project grants, including those below the absolute cap of $6.25 million direct cost. Support for such expansions must be sought through separate grants.
2. Application

   Preparation of a renewal application should follow the instructions provided in the section of this document entitled "Preparation of P01 Grant Application." An additional one page introduction is allowed for the overall research plan of renewal applications. Retain the number and letter designations for projects and cores in the present grant. Include a general progress report that highlights achievements under the program project since the last review . A more specific progress report will be required for each individual project and core unit in other sections of the application. The general progress report should include the following information:

   1. A brief summary of major accomplishments that can be attributed to the program project grant, a brief explanation of how these accomplishments have contributed to the achievement of the stated objectives of the grant, and a demonstration that synergy has occurred.
   2. Evidence that the previous specific aims have been accomplished and that the new research goals are logical extensions of those aims.
   3. The previous performance of the core(s);
   4. A list of projects and core units that have been discontinued, modified, or completed since the last competitive review, identified by number, title, and investigator with a brief rationale for the actions taken.
   5. The justification for adding new projects or cores or deleting a project or core.
   6. A list of all publications and "in press" (not "in preparation") manuscripts that have resulted from the program project grant, with credits to respective components (see Illustration 6). Do not list publications at the end of each component. The applicant must state clearly when publications have resulted from support through more than one funding source. The reviewers must evaluate the progress and achievements specific to the grant application under review. If this information is unclear, it can affect the review of the application. Illustration 6 is not included within the page limit for this section.
   7. A list of changes, if any, in professional staffing and how these changes have affected the overall program since the last review.
   8. A list of projects and core units in the current program, the amount of current funding for each, and the requested funding for the first budget period of each component that is requested for continuation in this program project renewal.
3. Progress Report

   The progress report for each component should relate specifically to the research supported by this grant and include the following information:

   1. Period--the beginning and ending dates for the period covered by the report;
   2. Detailed report--a description of the progress relative to the research objectives for period covered by the report, whether or not the work has been published. Adjustment of aims, such as those required due to programmatic adjustments to awards, should be discussed.

V. Additional Instructions for Revision (Competing Supplement) Applications

Revisions will be funded only for the continuation of projects that were originally funded for a time period shorter than the overall program project. Once a program project is funded, expanding its scientific size through submission of revision applications will not be possible. A supplemental request may be up to 3 percent above the previous year's support for that project(s). A one-page introduction is allowed for revision applications.

Strong justification must be provided for a program project revision application. It should contain sufficient detail to permit an adequate evaluation of the requested extension of time of projects/cores without having to refer to the parent application.

A letter of intent or direct consultation with NIDDK staff by the principal investigator of the original application may precede the submission of a revision. The named principal investigator of the revision application must be the principal investigator of the parent program project.

In addition to the instructions given in the "Preparation of Application" section, the following points should be noted for supplemental applications:

1. A revision application will not be accepted before the original application receives an award.
2. The format as described previously for new applications is to be followed for the competing supplement application. Thus, the budgets (Illustrations 2 and 3) described earlier are to be provided, as well as active and pending support. In addition, the funding relationship between the parent grant and the supplemental request is to be shown in table form (Illustration 7). "Current support" is defined as the first budget period of the parent grant to which the supplement would be added.
3. Program Introduction and Statement of Objectives must be included. In addition to the information requested, the reasons for the urgent need for supplemental support must be described.
4. A summary report of progress made in the overall program since the previous competitive review must be discussed. List any publications relevant to the supplemental request using the format in Illustration 6 (Illustration 6 is not included in the page limits).
5. In the request for extension of ongoing projects and/or cores that were reviewed in the original application, a detailed description of each component for which supplemental funds are requested should be presented in the format previously described for new/renewal applications. Retain the number and letter designations from the current grant. The progress report for each project should include information describing events that led to the need for supplemental support. For extension of ongoing cores, summarize the utilization and value of the core unit during the preceding project period.

VI. Additional Instructions for Resubmission (Revised or Amended) Applications

Effective with the June 1, 2005 receipt date, NIDDK will accept only one amended application for P01s. Only A1 submissions will be accepted; A2 submissions will no longer be accepted. See: http://grants1.nih.gov/grants/guide/notice-files/NOT-DK-05-006.html

Preparation of a resubmission application should follow the instructions provided in the section of this document entitled "Preparation of P01 Grant Application." A revised application will be returned if substantive changes are not clearly apparent and identified. Simple deletion of components or aims does not constitute substantive revision. Discussion with NIDDK program staff is encouraged prior to submission.

The following additional guidelines should be followed in the preparation of a resubmission application:

1. Preceding the Research Plan for the overall program project, provide a one-page introduction that summarizes the additions, deletions, and changes that have been made.
2. Preceding the Research Plan for each component, provide a one-page Introduction that responds to the criticisms of the previous summary statement and that summarizes changes made in the research plan.
3. Incorporate in the Progress Report/Preliminary Results a discussion of any work done since the previous submission.
4. In all parts of the application, revised portions or passages must be clearly identified to facilitate the review of the revised aspects of the application.

VII. Receipt Dates and Copy Requirements

The receipt dates for program project applications are listed in http://grants.nih.gov/grants/guide/notice-files/NOT-DK-06-023.html. All types of applications (new, renewal, resubmission, and revision) will be accepted for all three receipt dates.

P01 Applications: Receipt, Review, and Award

Letter of Intent*	Receipt Date for Applications	Initial Review	Council Review	Earliest Possible Start Date
Minimum of 3 months prior to application receipt date	Jan 25 May 25 Sept 25	May-Aug Sep-Dec Jan-Apr	Sep Feb May	Dec 1 Apr 1 Jul 1

*Letter of intent is highly encouraged but is not mandatory. Prior approval of all submissions, including program projects, with budgets of $500,000 or more in direct costs is required (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html).

To maximize the likelihood of the continuity of funding, grantees are encouraged to submit competing continuation applications at least 1 year prior to termination of the current project period. The original and three copies of the application should be sent or delivered to the following address:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive , Room 1040 - MSC 7710
Bethesda , MD 20892-7710
Bethesda , MD 20817 (for express/courier service)

Do not send appendices to the above address.

Two additional copies of the application along with all appendices (five CDs) should be sent to:

Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
2 Democracy Plaza, Room 752
6707 Democracy Boulevard , MSC 5452
Bethesda , MD 20892-5452
For courier/express delivery, please use 20817 ZIP code
Phone: (301) 594-8897
Fax: (301) 480-3505 or (301) 480-4126

VIII. Reporting Requirements and Annual Evaluation

Annual progress reports, submitted as part of the annual noncompeting continuation application, are used by the NIDDK and advisory committees to review the program project and its progress. These reports serve to verify in detail the achievement of the objectives outlined in the initial application and award. The NIDDK staff may, as necessary, assemble consultants to review the progress of the program project or to discuss major changes in the program that may require budget adjustments and/or review by the National Diabetes and Digestive and Kidney Disease (NDDK) Advisory Council.

The progress report should describe the progress during the past budget year as indicated under the instructions for competing continuation applications. This expanded progress report does not replace other management reports required by PHS policy.

IX. Review Guidelines

1. General Review Considerations

   For a program project application to be assigned a priority score, at least three component projects must be judged to have sufficient scientific merit to receive priority scores. At least three projects must extend for the duration of the program project. The NIDDK is interested in supporting only the best research; individual research projects that are relatively lower in merit may not be funded under the "umbrella" of the program project mechanism. It is primarily for this reason that each project will be assigned a separate priority score, taking into consideration only its merit as an individual research project. It is important that each project fits and contributes to the theme of the overall program project, but this factor should be judged separately and has no bearing on a project's individual priority score. Instead, these considerations will be addressed later with respect to the merit of the overall program project.

   It is expected that individual components, in order to receive funding, should in general receive scores similar to those for R01 applications. The NIDDK may identify a priority score cut-off for the funding of individual components in a program project. A project whose score is somewhat poorer than currently funded R01 grants may benefit greatly from inclusion in the overall program project, whereby synergism with other components and use of core facilities significantly enhances its value. Conversely, such a project might provide certain elements that greatly enhance other projects in the overall program project. Such considerations would be expected to have an impact on the overall priority score assigned by the reviewers to the program project.

   Requested core budgets may need to be adjusted downward if it is recommended that some of the individual projects utilizing their services are reduced in scope or if they are recommended for no further consideration. Therefore, it is important for both the applicant and the reviewers to address the contribution of the core to each project in both scientific and budget terms. Projects may be deleted during second level review (staff and Advisory Council) when they have priority scores significantly lower than those of the other projects within the program project or significantly lower than those of fundable individual research applications of the NIDDK.

   All applications except revisions (competing supplements) must request and be reviewed for 5 years of project period support. While one or more projects may be recommended for less than 5 years, only in very unusual circumstances may the entire program project be recommended for less than 5 years.

   Any questions regarding these procedures may be directed to:

   Chief, Review Branch
   Division of Extramural Activities
   National Institute of Diabetes and Digestive and Kidney Diseases
   2 Democracy Plaza, Room 752
   6707 Democracy Boulevard , MSC 5452
   Bethesda , MD 20892-5452
   Phone: (301) 594-8897
   Fax: (301) 480-3505 or (301) 480-4126

2. Review of Individual Projects

   For each research component judged to have sufficient scientific merit, a priority (impact) score will be assigned, based on the criteria for the review of individual research projects. For each project, the reviewers will enter criterion scores for the five major review criteria listed below, and will prepare their critiques using the template provided by the Scientific Review Officer.

   The review criteria for individual research projects are given below:

3. 
   
   
   Significance: Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
   
   Investigators: Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?
   
   

   Innovation: Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

   Approach: Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

   If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

   Environment: Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
   
   

   Additional Review Criteria. As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.

   Protections for Human Subjects. For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

   For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.

   Inclusion of Women, Minorities, and Children. When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.

   Vertebrate Animals. The reviewers (committee) will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia.

   Biohazards. Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

   Additional Review Considerations. As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in the overall impact score.

   Budget and Period Support. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

   Select Agent Research. Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

   Applications from Foreign Organizations. Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

   
   3. Review of Individual Cores

The review criteria for the individual cores are given below (cores receive merit descriptors rather than numeric scores):

1. Utility of the core to the program project; each core must provide essential facilities or service for two or more projects judged to have substantial scientific merit;
2. Quality of the facilities or services provided by this core (including procedures, techniques, and quality control) and criteria for prioritization of usage;
3. Qualifications, experience, and commitment of the personnel involved in the core; and
4. Appropriateness of the timetable in relation to the scope of the proposed research support.
5. If human subjects, vertebrate animals, or biohazards are to be used in the core, the adequacy of these sections must be assessed and will be considered in determining the score of the individual core.

In the case of the review of a renewal (competing continuation) application, the progress made during the past period of funding is also an important consideration in the review of projects and cores.

1. Review of Overall Program Project

   The relationship and contributions of each research component and core (excluding those recommended for no further consideration) to the overall theme of the program project will be discussed and evaluated; these points must be clearly and specifically outlined in the summary statement. This should be a separate consideration which is not determined exclusively by the priority scores of the individual projects. Although projects that are not scored are removed from consideration as part of the overall program project, the inclusion of such projects will reflect on the leadership capabilities of the principal investigator/program director.

   The overall program project application is evaluated considering the priority-scored projects, supporting cores, and the administrative structure. For a program project to receive a priority/impact score, it must consist of at least three scored individual projects for the duration of the project period. Each core must provide essential functions or services for at least two of these projects.

   1. Specific factors to be evaluated in the consideration of the overall program project are as follows:

   a. Scientific merit of the program as a whole, as well as that of individual projects, and its potential impact on the field;

   b. The evaluation of the overall program in terms of significance, approach, innovation, investigators, and environment;

   c. Scientific gain of combining the component parts into a program project (beyond that achievable if each project were to be pursued separately);

   d. Cohesiveness and multidisciplinary scope of the program and the coordination and interrelationship of all individual research projects and cores to the common theme;

   e. Leadership and scientific ability of the principal investigator/program director and his or her commitment and ability to develop a well-defined central research focus (request of support for sufficient effort to provide effective oversight and administration of the program should be considered); and

   f. Past accomplishments of the program or a demonstrated ability in mounting similar programs.

2. g. Resource Sharing Plans. Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan (http://grants.nih/gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).

3. 2. Additional criteria for renewal (competing continuation) applications include

4. a. Progress and achievements specific to this program project since the previous review and the evidence through publications, conferences, etc., that collaboration has occurred;

   b. Evidence that the previous specific aims have been accomplished and that the new research goals are logical extensions of ongoing work;

   c. Previous performance and estimated use of the core(s); and

   d. Justification for adding new projects or cores or for deleting components previously supported.

   3. Additional criteria for revision (competing supplement) applications include

   a. Carefully conceived and explained rationale for extension of currently funded projects; and

   b. Progress made through the overall program project to warrant the extension.

   E. Administrative Considerations

5. For all program project applications (new, competing continuation, and supplemental), in addition to evaluating the scientific components, the review also will assess

6. 1. Academic environment where the research will be conducted, including availability of space, equipment, human subjects, animals, or other resources as required, and the potential for interaction with scientists from other departments.
   2. Institutional commitment to the requirements of the program, including fiscal responsibility and management capability of the institution to assist the principal investigator/program director and his or her staff in following DHHS, PHS, and NIH policy.
   3. Administrative planning and leadership capability to provide for internal quality control of ongoing research, allocation of funds, enhancement of internal communication and cooperation among the investigators involved in the program, and replacement of the principal investigator/program director if required on an interim or permanent basis.
   4. Appropriateness of the budget in relation to the proposed program.
8. F. Final Recommendation

   If the overall program project is judged to have sufficient merit, a priority score will be assigned based on the application's merit as a program project. This score is not the average of the priority scores assigned to the individual components. If a component project lacks sufficient scientific merit, it will receive neither a priority score nor a budget recommendation, and it will not be considered in the assignment of an overall priority score.

   It is possible that one or more of the components will have excellent scientific merit but fit poorly, or not at all, within the program project. Such projects may be deleted from the program project and thus would be omitted from consideration when assigning the final priority score to the overall program project. Conversely, components with relatively poorer scientific merit may contain parts that would strengthen or bridge other proposed projects. Therefore, the review committee specifically should address the value of each project to the overall program project and the resultant synergy.
   
   

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