Guidelines for Program Project Grants

National Heart, Lung, and Blood Institute
National Institutes of Health

Revised: January 2008

Note the following policy changes, all of which are effective for applications to be received by the NHLBI after July 1, 2004: The NHLBI no longer restricts the number of individual components of a program project grant application that can be submitted from organizations other than the applicant organization. However, all program project grant applications must provide a compelling justification for how the proposed program structure will encourage and enable extensive interactions among investigators and accelerate the acquisition of knowledge. The NHLBI is interested in supporting new and innovative research through the program project grant. Therefore, no more than half of the projects included in a funded program project grant application may include projects that significantly overlap in time and objectives with currently funded individual research project grants, i.e., individual research project grants that would have to be relinquished if the program project grant application is funded. The Principal Investigator of a program project grant must be a research scientist of recognized stature in his/her scientific discipline with the demonstrated ability to ensure quality control and to administer and integrate all components of the program. If the NHLBI decides to reinstate a project because of a meritorious score of the project when submitted as an R01 application, the Principal Investigator must be the same on both. (See Chapter 4, Section H, for other criteria that must be met as well.) Conditions under which a program project grant may be transferred to another institution are specified. (See Chapter 4, Section H). Applications for NHLBI Program Project Grants with direct costs of $500,000 or more in any year must also comply with the NHLBI Guidelines for Applications with Direct Costs of $500,000 or More in Any One Year.

INTRODUCTION

The Institute is particularly interested in encouraging new scientific directions in program project grants. The P01 mechanism is viewed as an opportunity to attract scientists who have not traditionally been supported by the NHLBI. However, all projects must be interrelated and have objectives that address a central theme within the mandate of the Institute.

PRESUBMISSION

ANYONE planning to submit a P01 application (new competing [Type 1], competing renewal [Type 2], supplemental [Type 3], or amended [A1]) must send a letter of intent at least 2 months prior to submission. Details regarding the letter of intent are in Chapter 4, under Application and Review Process, Section A (Presubmission).

Anyone planning to submit a NEW P01 application:

• Must contact NHLBI program staff early in the process (2 to 3 months prior to the receipt date). Staff will engage in detailed discussions with the proposed principal investigator and offer advice and suggestions that may involve more extensive personal consultation and a review of the draft application by the staff. However, staff will not comment on the merit of the science proposed.
  
  
• Must contact NHLBI staff at least 6 weeks prior to any receipt date as required by the NHLBI Guidelines for Applications greater than or equal to $500K in direct costs to discuss the draft application and obtain written approval from the NHLBI that it will accept the application. Additional information can be found in the published NIH policy (http://grants2.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html).

New applications submitted without prior consultation with NHLBI staff will be returned without review.

Anyone planning to submit a COMPETING CONTINUATION OR AMENDED application must send a letter of intent at least 2 months prior to submission but do not need prior approval to submit an application.

Applications that do not follow this presubmission guidance, are not prepared according to the instructions, or do not meet the criteria for a program project grant will be RETURNED TO THE APPLICANT WITHOUT PEER REVIEW.

CHARACTERISTICS OF A PROGRAM PROJECT

A program project grant application is responsive to NHLBI Guidelines if it has the following:

A.    A clearly defined, unifying, central theme to which each component project relates and to which each research investigator contributes.

• In keeping with the tradition of investigator initiated research, the NHLBI expects the applicants to define the integrating theme and to develop multidisciplinary approaches used to accomplish the objectives of the proposed research.
• The central theme must be clearly developed in the introduction and must be accompanied by a compelling scientific rationale for using the program project mechanism to conduct the proposed multi-disciplinary research, as opposed to a group of separate individual research project grants.
• The central theme of the research program may bridge the programmatic responsibilities of two or more NHLBI Divisions. The theme of the scientific research, not the organizational structure of the NHLBI, should define its boundaries.
• The target goals anticipated on completion of the 5-year program should be outlined carefully in the introduction with special reference to contributions expected from the multidisciplinary team.
• Examples should be presented of previous collaborations that may have led to the goals and hypotheses of the program.

B.    Component research projects that are interrelated and contribute scientifically to the central theme of the program.

• The relationship of hypotheses and goals of each component project to the central theme should be described.
• Each component project requires a well described hypothesis or plan for discovery research, preliminary data, and a timetable for conducting the proposed investigations.
• Component projects may be basic research, clinical research, or a combination of basic and clinical research. Population-based research is acceptable as one of several projects in the program if the objectives of the project can be completed in a 5-year project period. A program project grant may not be used to support Phase III clinical trials. The usual NIH policies concerning research on human subjects apply. Instructions for Form PHS 398 should be followed for addressing use of human subjects. Some additional details are available in Chapter 2, Section D.4.e. of this document.
• If core facilities are included, the scientific and fiscal relationship of each component project to each core should be described and fully justified.
• A program project requires a minimum of three interrelated component projects, each of which is funded for 5 years.
• In general, each individual project in a program project grant should have a different project leader. Although individual investigators are not precluded from leading more than one project in a program project grant, strong justification must be provided for all such instances. In no case may one individual serve as project leader on more than two projects and each funded program project grant must have a minimum of three individual project leaders.
• No more than half of the projects included in a funded program project grant application may include projects that significantly overlap in time and objectives with currently funded individual research project grants, i.e., individual research project grants that would have to be relinquished if the program project grant application is funded.

C.    A principal investigator who is a research scientist of recognized stature in his/her scientific discipline and has the demonstrated ability to ensure quality control and to administer and integrate all components of the program.

• A principal investigator must devote a minimum of 25 percent time commitment to the grant.
• A principal investigator must also be the project leader of one of the component projects submitted and ultimately funded. If the project submitted by the principal investigator is judged by peer review to be of low scientific merit, this will markedly reduce the overall scientific merit ranking assigned to the entire application by the review committee. If the project submitted by the principal investigator does not receive a fundable score, the program project grant application will not be funded.
• A principal investigator must be fully established at the applicant institution at the time of submission of a program project grant application.

D.    Project leaders who provide expertise from several disciplines.

• Project leaders must be individuals whose scientific publications demonstrate their potential to contribute to the overall theme of the program project.
• Project leaders must agree to commit at least 20 percent effort to the project for which they are responsible.
• Investigators with excellent research training, who have not yet achieved established investigator status, may participate; however, most of the project leaders should be investigators with significant research experience.
• Project Leaders must be fully established at their institutions at the time of submission of a program project grant application.

E.    Core leaders who have appropriate expertise

• Core leaders must be qualified for their role(s) in the core unit.
• Core leaders should dedicate time and effort commensurate with the complexity of the core unit's function.

F.    A plan to ensure extensive interaction among all participants and the communication of ideas and results.

• A compelling justification must be presented for how the proposed program structure will encourage and enable extensive interactions among investigators and accelerate the acquisition of knowledge.
• Both internal and external advisory committees should be established to evaluate progress and the effectiveness of interaction among participants. See Chapter 2, section C.3. for additional guidance on creating advisory committees and naming members in the application.

G.    A section titled "Synergy and Interactions Among Projects and Project Leaders." The section must address:

• Collaborative aspects, inter-relatedness of research, and the contribution of each project to both the central theme of the application and the other projects included in the application.
• Multi-authored publications that demonstrate recent collaboration among investigators included in the application and among the project leaders in particular.
• A description of inter-project use of resources and research findings.
• A proposed schedule of seminar series, monthly group meetings, semi-annual retreats, or other features that will stimulate collaboration and interaction among investigators included in the application.
• The role of external and internal advisory committees, their interactions with each other and with the project leaders.
  

CHAPTER 2

GUIDELINES FOR THE PREPARATION 
OF A PROGRAM PROJECT GRANT APPLICATION

A. Introduction

The exceptions and additions noted below are the only changes from the general requirements provided in the instructions for PHS Form 398. Page limitations specified for R01 grant applications in PHS Form 398 apply to each project and core unit of a P01 application.

B. Specific Instructions

1. Face Page (page 1 of application): Type "Program Project" on line 2. The title of the grant application must not exceed 56 characters. Complete all items on the face page of the application. This is page 1 of the application; all succeeding pages should be numbered consecutively.
   
   
2. Description, Performance Sites, and Key Personnel (see PHS Form 398 Instructions)
   • State concisely the overall goals of the entire P01 and the contribution of each component to the overall goals.
   • In the block requesting key personnel, add the position title and department for each individual.
     
     
3. Table of Contents
   • Provide a detailed table of contents that will enable readers to find specific information readily. List each project, the budget for each project, each core unit, and the budget for each core unit, and supply the page number for each item. Identify each project by title, assign each project a number that reflects the order in which the projects are presented in the application, and provide the name of the project leader or responsible investigator. (In the case of competing continuation applications, identify each project with the same number used for it in the previous application, or, if projects have been dropped or added, arrange the numbers in sequence and identify projects being proposed for continuation with their former numbers.)
     
   
   
4. Detailed Budget for Initial Budget Period
   1. All Program Project Grant Applications
      • Provide a detailed categorical budget for EACH PROJECT AND EACH CORE UNIT in their respective sections of the application. In addition, provide and identify a complete budget for each consortium project
      • Incorporate a detailed budget for all requested support for the first year ( Sample Table 1). For each category, such as "Personnel," "Equipment," "Supplies," "Travel," and "Other Expenses," give the amount requested for EACH PROJECT AND CORE UNIT with subtotals. If contractual arrangements or "purchased services" involving other institutions or organizations are anticipated (as in project 5 in Sample Table 1), include total (direct and facilities and administrative) costs associated with each third party participation in the " Consortium/Contractual Costs" category.
        
        
   2. New Program Project Grant Applications
      • New applications may request direct costs in the first year up to the maximum allowable direct costs for the fiscal year (FY) in which funding is proposed to begin (The most recent maximum allowable direct costs are posted on the NHLBI Web site (at http://www.nhlbi.nih.gov/funding/policies/grantcaps.htm). The allowable rate of increase in the direct costs for subsequent years is also posted on the NHLBI Web site (at http://www.nhlbi.nih.gov/funding/policies/operguid.htm). Requests for expensive items of equipment that cause an application to exceed the posted limits may be permitted on a case-by-case basis, following staff consultation. However, applicants should make every attempt to include all equipment in the ceiling amount. Applicants must discuss equipment requests with NHLBI staff early in the planning phase and must receive permission from the Institute to include equipment costs in their budget request. All requests for equipment that may cause an application to exceed the posted NHLBI limits require in-depth justification. Final decisions depend on the nature of the justification and the Institute's fiscal situation.
        
        
   3. Competing Continuation Program Project Grant Applications
      • In the first year of a competing continuation application, direct costs are allowable up to the posted maximum allowable direct costs for the FY in which the funding is proposed to begin or a 10 percent increase over the recommended amount shown on the award statement for the last noncompeting year, whichever is greater (not including F & A costs in consortia arrangements). The increase in the direct costs in each subsequent year and equipment costs are governed by the same policies as outlined above for new applications.
      
      
      
5. Budget for Entire Proposed Period of Support.
   • Prepare a detailed categorical budget that provides totals for each year of requested support. Requests for any increases in succeeding years must be clearly stated and any changes in percent effort and funds must be justified in the individual project and core unit budgets.
   
   
   
6. Biographical Sketch (see PHS Form 398 Instructions)
   
   
7. Other Support
   • Do not include Other Support as a separate section. Although information on Research Support is important in evaluating the qualifications of proposed staff for their roles and for assessing the degree of commitment that is feasible, a description of other support should be included as part of the Biographical Sketch (Research Support) and should not exceed two pages.
   
   
   
8. Resources (see below under Research Plan)
   
   
9. Research Plan
   • FOLLOW THE FORMAT OF THE PHS FORM 398 for each project, providing supplementary information when necessary for each section as indicated below. Describe each research project and each core unit in the same detail that is required for an individual research project grant application, so that the scientific merit can be judged on the basis of the written proposal. Keep in mind that the application will be reviewed by experts who can 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 project should be concise yet explicit enough to enable experts in related areas to understand the main thrust of each project and how it relates to the overall program project grant.
     
     
   • Page limitations specified for R01 applications in PHS Form 398 apply to each project and core unit section. Applications exceeding the page limitation will be returned without peer review. Additional information concerning collaboration and integration between projects and cores and the contribution of each component to the program's specific goals should be succinct. Unnecessarily long, wordy, or confusing presentations are usually perceived as indicative of premature or poorly planned research. The bibliography is not counted toward the 25 page limitation per project.
     
     
   • Full-sized glossy photographs of materials such as electron micrographs or gels may be sent to the Scientific Review Administrator for distribution to the reviewers so long as a photocopy (which could be reduced in size from the glossy photograph in the appendix) is included within the 25-page limit of sections a-d of the Research Plan. All other graphs, diagrams, tables, and charts must be included within the 25-page limit of sections a-d in the Research Plan. The appendix may not be used to circumvent the page limitations in the Research Plan. Applications that do not conform to these restrictions will be returned without peer review. An appendix will not be duplicated with the rest of an application. Therefore, material in an appendix should be sent directly to the Scientific Review Administrator (SRA). (The SRA will instruct the applicant as to when to send extra materials.)

C. Additional Format Instructions - The following sections must precede the portion of the application that contains the details of the individual projects.

1. Program Introduction and Statement of Objectives
   • A program project grant should be viewed as a group of interrelated research projects, each of which is not only individually meritorious scientifically but also complementary to and interrelated with the other projects in the research program and contributes to the integrating theme. The theme of a proposed program project grant should be established in the first few sentences of the general introduction.
   • Describe the rationale for the proposed total research program. Explain the strategy for achieving the objectives of the overall program and how each research project and core unit relates to that strategy and to each other.
     
   • The general introduction of the overall program description is the appropriate place to indicate any prior collaborative arrangements between investigators in the group, to explain the genesis of the current application, to predict the anticipated unique advantages that would be gained by the research within the proposed program project grant, to describe how the projects are synergistic and mutually interrelated, and to explain how the proposed program project grant would enable the stated objectives of the proposed research to be addressed more efficiently and effectively than a group of individual research project grants. (See also Chapter 1, Sections F and G above).
     
     
2. Institutional Environment and Resources
   • Briefly describe the features of the institutional environment that are relevant to the effective implementation of the overall 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. The information requested here supplants the "Resources" page in the PHS Form 398 grant application, which is NOT to be used.
     
     
3. Organizational and Administrative Structure of the Program Project Grant
   
   
   • CHAIN OF RESPONSIBILITY. Describe in detail, and by diagram if appropriate, the chain of responsibility for decision making and administration, beginning with the principal investigator and including the leaders of the research projects and core units. Indicate where, in the chain of responsibility, advisory groups (internal and external consultants) would be used, and describe their function in ensuring quality control in the research efforts.
     
     
   • EXTERNAL AND INTERNAL ADVISORY BOARDS. Every program project grant should have plans for both an external advisory board and an internal advisory board. The external advisory board should normally consist of two or three named advisers committed to the evaluation of the program by written documentation. Two or three additional advisers may be added once the progress of the program and its needs are clearer. New program project grant applications should not constitute their external advisory board prior to or during the review of their application because individuals identified in an application cannot participate in its peer review. The internal advisory board should consist of three to five members outside of the program but within the applicant institution (or within neighboring institutions) who are able to assist in frequent, ongoing reviews.
     
     
   • SPECIFIC MANAGERIAL RESPONSIBILITIES: Indicate who would be responsible for assisting the principal investigator with day-to-day administrative details, program coordination, and planning and evaluation of the program.
     
     
   • RELATION OF THE PROGRAM PROJECT GRANT ORGANIZATION TO THE ADMINISTRATION OF THE APPLICANT INSTITUTION: Describe the relation between the proposed program project grant and other existing research, academic, and administrative units of the applicant institution such as schools, centers, institutions, departments, and central administration.
     
     
   • CONSORTIUM ARRANGEMENTS: Applications that include research activities involving institutions other than the applicant institution are considered consortia. Consortia applications must be prepared so that the programmatic, fiscal, and administrative considerations are explained fully. The published policy governing consortia is available in the business offices of institutions that are eligible to receive Federal grants-in-aid. Consult the latest published policy governing consortia before preparing an application. If clarification of the policy is needed, contact the Chief of the Grants Operations Branch, Division of Extramural Affairs, NHLBI, at 301-435-0144.
     
     
   • DESIGNATION OF REPLACEMENT FOR PRINCIPAL INVESTIGATOR: Describe the procedure for selecting a proposed replacement for the Principal Investigator, should the need arise. The NHLBI must approve any request to replace the Principal Investigator.
     
     
4. Summary Report of Progress
   
   Competing continuation applications must include a progress report that highlights achievements under the program project grant since the last competitive review. A progress report is required for each research project and core unit in other sections of the application. The composite summary/progress report must include:
   • A brief summary of major accomplishments that can be attributed to the program project grant and a brief explanation of how they relate to the stated objectives of the program.
   • A list of all publications and completed (not "in preparation") manuscripts that have resulted from the program project grant.
   • A list of changes, if any, in the professional staffing since the last competitive review.
   • A list of research projects and core units, in tabular form, that have been discontinued, modified, or completed since the last competitive review, identified by number and title, with a brief explanation of the actions taken.
   • A list of research projects and core units in the current program project grant, with the amount of current funding for each and the requested funding for the first budget period of each project and core unit that would be continued in the program project grant. Identify each as a "new" or "continuing" component.
   
   
   

D. Individual Projects

1. Title and number each research project so that it can be readily distinguished from any other project in the program. An individual description should be prepared for each project in the program project grant application as would be required for an R01 application. The title must NOT exceed 56 typewriter characters/spaces. DO NOT provide a face page (i.e., PHS Form 398 face page) for individual projects. Provide the name and academic title of the project leader and each participating investigator. This request is being made pursuant to the basic authority of the NHLBI to award research project grants (see Title 42, United States Code, Section 241).
   
   
2. Present the budget for each research project according to the instructions for PHS Form 398. A detailed categorical budget is required for the first and all subsequent years. Include budget requests and explicit detailed budget justifications for all years.
   
   
3. Describe in detail the facilities to be used by each project. This is to be accomplished by completing the "Resource and Environment" page included in the PHS Form 398 grant application packet.
   
   
4. Research Plan: State the overall objective for each proposed research project and explain how it relates to the central theme of the program project grant and how it interrelates with and complements and/or supplements, the other research projects and core units of the program project grant. In addition, describe the overall expected biomedical significance of the proposed research.
   
   
   1. Specific Aims
      • List the specific aims of the research project for the total period of requested support. Indicate the general priority of each aim in the overall research plan.
        
        
   2. Background and Significance
      • Review the most significant previous work and describe the current status of research in this field: document with complete references.
        
        
   3. Preliminary Studies/Progress Report
      • Refer to PHS form 398 Instructions for Preliminary Studies.
      • See under Summary Report of Progress Studies.
        
        
   4. Research Design and Methods
      • Give details of the research plan, including a description of the experiment(s) or other work proposed; present the methods and techniques to be used; note the limitations, if any, of the procedures proposed. In so far as possible, describe the experiments in the sequence in which they would be conducted. (It is important to convey to the reader that the proposed effort would require the time requested for the project period.)
      • Discuss the kinds of results expected from the experimental procedures described in the "Methods of Procedure" section, and explain how the data would be analyzed and interpreted. Discuss the extent to which anticipated results would relate to the original hypothesis and how they would be important for planning the next steps in the research plan.
        
        
   5. Human Subjects
      • The usual NIH policies concerning research on human subjects apply. Form 398 should be followed for human subjects information.
        
        
      • NIH policy requires applicants for NIH clinical research grants and cooperative agreements to include minorities, women, and children in study populations so that research findings can benefit all persons at risk for the disease, disorder, or condition under study. Special emphasis should be placed on the need for inclusion of minorities, women, and children in studies of diseases, disorders, and conditions that disproportionately affect them. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear and compelling rationale must be provided. Refer to chapter 1, B. for the appropriate types of research in a program project grant.
        
        
      • The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information should be included on PHS Form 398 in Sections a-e of the Research Plan AND summarized in Section e, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, the NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of U.S. racial/ethnic minority populations (i.e., Native Americans including American Indians or Alaska Natives, Asian Americans, Hawaiians and other Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups should be provided.
        
        
      • For foreign studies and domestic studies with a foreign component, the NIH policy on inclusion of women, children, and minority groups in research is the same as that for research conducted in the U.S.
        
        
      • If the required information is not contained within the application, the application will be returned without review.
        
        
   6. Vertebrate Animals (see PHS Form 398 Instructions.)
      • If animals are involved, indicate what kinds are to be used and whether nonhuman primates are to be used, listing the special justifications for their use, and describe in detail their care, use, and treatment and the method to be followed for euthanasia.
        
        
   7. Literature Cited
      • Include a complete citation for each reference in the text. TITLES OF REFERENCE PUBLICATIONS SHOULD BE INCLUDED.
        
        
   8. Consortium/Contractual Arrangements and/or Collaborative Arrangements (See PHS Form 398 Instructions)
      • Describe the collaboration of investigators within the program project grant. Describe in detail any other collaborative arrangements anticipated, either within the applicant institution, between it and other institutions, or among other institutions.
        
        
   9. Consultants (See PHS Form 398 Instructions)
      
      
5. Appendix
   • Appendix materials should NOT be included as part of a grant application. They may be submitted as additional material at the same time that reprints are provided in response to a request from the SRA.
     
     

E. Individual Core Units

A core unit is defined as a resource for the program project grant that provides centralized services to more than one of the research projects.

1. Title and assign a LETTER designation to each core unit so that it can be readily distinguished from any other core unit. Do NOT exceed 56 typewriter characters/spaces for each title.
   
   
2. Provide the name and academic title of the core unit leader and each participating investigator.
   
   
3. Describe the function of the core unit as a resource to the program project grant. This section must present clearly the facilities, techniques, and professional skills that the core unit would provide to the program and explain why its inclusion is essential to two or more of the individual research projects and to the overall research program.
   
   
4. Describe in detail the facilities to be used by EACH core unit. This is to be accomplished by completing the "Resource and Environment" page included in the PHS Form 398 grant application packet.
   
   
5. Present the budget for each core unit in the format and according to the instructions for Form 398. A budget for the entire proposed project period is required for all subsequent years of support (direct costs only). Include explicit and detailed categorical budget justifications for all years and fully describe how the costs interrelate with those of the projects serviced by the core unit.
   
   
6. Relation of the Core Units to the Research Projects: Provide in tabular form information concerning the research projects that each core unit would serve and the proportion of the cost of the core unit associated with each research project involved (Sample Table 2).
( Sample Table 2 ).

CHAPTER 3

ADDITIONAL GUIDELINES FOR THE PREPARATION OF A SUPPLEMENTAL PROGRAM PROJECT GRANT APPLICATION

Supplemental program project grant applications may only be submitted to the NHLBI for continuation of funding of component projects originally recommended for a period shorter than the project period for the program project grant. In such cases, after NHLBI staff has been apprised of the applicant's intent, a supplemental application may be submitted to bring the component project's funding into synchrony with the rest of the program project grant.

Strong justification must be provided for the proposed supplement. The project must be described in sufficient detail to ensure adequate evaluation solely on the basis of the written proposal.

A. Program Abstract

On page 2 of the application, in the space provided, give a brief description of the entire program in addition to a summary of the supplemental request.

B. Budget

Use the instructions from PHS Form 398, "Detailed Budget for Initial Budget Period," to present a composite budget for the first continuing year (or portion thereof) of the supplemental request. For each category, give the amount requested for each research project and core unit and the total for the category. Use a format such as that suggested in the presentation of a composite budget for the first year budget section of new and competing continuation applications (Sample Table 1 in the Appendix).

Use the instructions for "Budget for Entire Proposed Period of Support," of PHS Form 398 to prepare a budget, by category, for all years of supplemental request. The first year of the supplement may be no more than 3 percent greater than the last funded (or committed) year. The budget is subject to a maximum increase of no more than 3 percent in each succeeding year.

Submit a detailed budget for the "Personnel" category for the first year of supplemental request.

Show the funding relation between the parent grant and the supplemental request by a summary table.

Use the column title "Prior Year Budget" to indicate the funding allocation for the year preceding the year for which funds are being sought in the supplemental grant application. In the column titled "Current Grant" indicate the current funding for the supplemental projects or core units for the first year for which supplemental funding is being sought.

C. Budgetary Information Related to the Parent Grant

Include the following tables:

1. The budget remaining for the parent grant. Provide a table for each year of the parent grant that coincides with the requested budget period(s) of the supplemental application.
   
   
2. Any changes, with brief explanations, in the budgets of research projects and core units since the last competitive review. In particular, note and explain any rebudgeting of funds between projects and core units.
   
   

D. Summary Report of Progress

A comprehensive progress report covering the period since the beginning of the project period to the present is required for all supplemental applications. This summarizing progress report, which is to be prepared by the principal investigator, must include:

1. A brief summary of major accomplishments that can be attributed to the program project grant and a brief explanation of how they have contributed to furthering the stated goals of the program.
   
   
2. A list of all publications and completed (not "in preparation") manuscripts that have resulted from the program project.
   
   
3. A list of research projects and core units, in tabular form, that have been discontinued, modified, or completed since the last competitive review, identified by title and number, with a brief explanation of the actions taken.
   
   
4. A list of changes, if any, in the professional staffing since the last competitive review.
   
   

E. Research Plan and Content

• Follow instructions for the Research Plan and project/core content as described in these guidelines and in PHS Form 398 for the format of Component Research Project and Component Core Unit.
  
  

CHAPTER 4

SUBMISSION AND REVIEW OF APPLICATIONS

Please note that only one amendment of a program project grant application will be accepted for review.

The timing of each step in the process and the corresponding earliest start date for each receipt date are indicated below.

1. The Application Review Cycles by Application Receipt Date

APPLICATION AND REVIEW PROCESS

The following phases will normally comprise the process of submission and review of a program project grant application:

A. Presubmission

1. All Program Project Grant Applications
   For all program project grant applications (new, competing continuation, supplemental, and amended), investigators are encouraged to discuss their intent to submit an application with NHLBI staff well in advance of the intended receipt date.
   • To enable the NHLBI to plan its review schedule, the Institute requires that at least 2 months before submission of the application, a letter of intent be sent to:

     Scientific Review Administrator
     Program Project Review
     Two Rockledge Centre, Room 7208
     6701 Rockledge Drive
     Bethesda, Maryland 20892-7924
     Bethesda, Maryland 20817 (for express/courier service)
     301-435-0303
     
     

   The letter should contain the overall program title and that for each of their component projects, together with the names of the Principal Investigator, and the Project Leaders.
   • To enable the Institute staff to advise whether the application meets the scientific and programmatic requirements for a program project grant and is prepared according to the technical guidelines, it is recommended that a draft application be sent to the appropriate Division Director and to the SRA, early in its preparation.
   • Questions concerning budgets and/or grants policy should be addressed to the Chief, Grants Operations Branch of the NHLBI.
     
     
2. New Program Project Grant Applications
   • To ensure that each application meets the policies and guidelines for program project grants and to encourage more complete and well-prepared documents, the NHLBI requires pre-submission discussions of new program project grant applications with staff.
   • New P01 applications with direct costs of $500,000 or more in any year must be accompanied by written NHLBI consent to submit an application. This requirement is based on NIH policy. (NIH Guide to Grants and Contracts, October 16, 2001)
     
     
3. Competing Continuation and Amended New Program Project Grant Applications
   • The NHLBI exempts competing continuation and amended new program project grant applications from the requirement for prior acceptance of applications with direct costs of $500,000 or more.

B. Submission

At the same time that the original and three copies of the grant applications are submitted to the Center for Scientific Review, National Institutes of Health, Suite 1040, 6701 Rockledge Drive MSC 7710, Bethesda MD 20892-7710 (20817 for express/courier service), TWO ADDITIONAL COPIES OF THE GRANT APPLICATION ARE REQUESTED TO BE SUBMITTED TO THE PROGRAM PROJECT REVIEW OFFICE (ROOM 7208, MAIL STOP 7924) BY A SEPARATE MAILING. A copy of the letter indicating the willingness of the NHLBI to accept the application must accompany any new program project grant application.

C. Streamlined Review

The HLBP, with the possible addition of temporary members, has the option to determine, prior to the tailored review, whether an application meets the criteria for a program project grant application and is of significant and substantial merit to warrant further review. Any application found by the HLBP not to meet these criteria, will not be scored and will not be considered further.

D. Tailored Review Committee

New, competing continuation, and amended program project grant applications are normally reviewed by a tailored review committee composed of scientific peers convened to review a group of program project grant applications with similar content.

Competing supplemental applications are normally evaluated by mail review and/or conference call review.

Amended applications in which the majority of projects (three or more) received outstanding priority scores but no more than two projects received less than outstanding scores during the initial review may also be reviewed by mail review and/or conference call in order to reevaluate those particular projects.

In preparation for the meeting of the Tailored Review Committee, the SRA will:

• Transmit questions from reviewers to the applicant in preparation for the review, if the SRA believes they are critical to the review.
• Allow submission of relevant new data acquired since the submission of the application, up to thirty days prior to the tailored committee review.
  
  

The Tailored Review Committee will:

• Assign a priority score to each project based on its intrinsic stand-alone scientific merit. This scoring process is to be comparable to that for R01 applications.
• Describe in the critique of each project its importance and contribution to the overall recommended program.
• Provide written comments on the overall program, as well as the synergy of the projects and how they are interrelated, one to another.
• Rate each core unit as "Recommended" or "Not Recommended" based on whether it is essential for the proposed research and has the capability to fulfill the proposed function. Reviewers will evaluate the number of projects serviced by the core unit (the core unit must service two or more projects); strengths and weaknesses of the proposed approaches, resources, and interactions; whether the investigators are qualified for their role(s) in the core unit and have dedicated appropriate time and effort commensurate with the complexity of its functions; and whether the proposed budget for the core unit is appropriate.

E. Heart, Lung, and Blood Program Project Review Committee Evaluation

The HLBP considers the review reports, makes recommendations, and assigns an overall scientific merit rating to each application. It may not change an individual project score assigned by the Tailored Review Committee, but it is asked to provide written comments to be included in its overall report if it has any disagreement with a project score.

F. National Heart, Lung, and Blood Advisory Council Review

The NHLBAC assesses the recommendations of the HLBP, taking into account the level of merit of the individual projects as well as the overall merit assigned by reviewers, overall programmatic considerations relevant to each application, and the total recommended budget.

G. Funding

• The NHLBI and the NHLBAC are committed to the program project grant as an important support mechanism to accomplish various research goals and opportunities.
• The NIH Plan for Managing the Costs of Biomedical Research has placed an increased emphasis on the total cost of an application as a factor in the funding decision. This affects program project grant applications and other research grant applications with a high total cost.
• To stabilize the base funding of program project grants, the NHLBI has set aside a percentage of its Research Project Grant budget for P01s.
• The priority scores assigned to the component projects are used as one factor in making funding decisions for program project grant components.

H. Post Award Issues

• If the Principal Investigator of a P01 moves to another institution, a request to transfer the P01 to that institution will be considered by the NHLBI only if all of the following conditions are met:
  • The institution from which the P01 would be transferred agrees to permit the transfer of the grant.
    • If the institution from which the P01 would be transferred refuses to permit the transfer, the grant will remain at that institution if a replacement Principal Investigator is proposed who is acceptable to the NHLBI. Otherwise, the grant will be terminated.
  • The institution to which the P01 would be transferred agrees to accept the grant.
    • If the institution to which the P01 would be transferred declines to accept the transfer, the grant will remain at the original institution if a replacement Principal Investigator is proposed who is acceptable to the NHLBI. Otherwise, the grant will be terminated.
  • The facilities and environment at the institution to which the P01 would be transferred are comparable or superior to those at the institution from which it would be transferred.
  • The Principal Investigator of the P01 demonstrates conclusively to the NHLBI that the grant can be effectively administered at the new institution and that interaction between all of the components of the project will not be impaired in any way.
    • If the NHLBI has any doubts about a request to transfer a P01, even if the transfer is acceptable to both institutions, the Principal Investigator must submit an application for competitive review as described in this chapter.
  • If the leader of an individual component of a P01 moves to another institution and the Principal Investigator of the P01 wishes to allow the component to relocate to the new institution along with the component leader, the Principal Investigator of the P01 must demonstrate conclusively to the NHLBI that the interaction between all of the components of the project will not be impaired in any way and request that the NHLBI approve the change.
  • The NHLBI will reinstate into a program project grant a project initially deleted from a P01 application by the Institute if all of the following conditions are met.
    • The project was submitted as an unsolicited R01 application, i.e., not in response to an RFA.
    • Reinstatement of the project is requested by the Principal Investigator of the P01, the Principal Investigator of the R01 application, and their respective Institution(s).
    • The Principal Investigator of the R01 application is the same individual proposed for the project in the P01 application.
    • The P01 is in the first or second year of its project period.
    • The scientific objectives of the R01 application remain consistent with the major theme of the P01.
    • The funds requested and approved for the R01 application do not exceed those initially requested for the project in the P01 application, including associated core costs.
    • The percentile assigned to the R01 application is equal to or better than that used for the R01 official payline for one or more of the Council meetings at which it would be considered.
    If all of these conditions are met, the NHLBI will reinstate the project (and associated core costs) for funding for the same period of time that remains in the parent P01 grant. A reinstated project may be included in the P01 base funding level when determining the allowable direct cost for a competing continuation application.

INSTITUTE CONTACTS

Director, Division of Lung Diseases
Two Rockledge Centre, Suite 10018
6701 Rockledge Drive
Bethesda, Maryland 20892-7952
301-435-0233

Director, Division of Blood Diseases and Resources
Two Rockledge Centre, Room 10160
6701 Rockledge Drive
Bethesda, Maryland 20893-7950
301-435-0080

Director, Division of Epidemiology and Clinical Applications
Two Rockledge Centre, Room 8100
6701 Rockledge Drive
Bethesda, Maryland 20892-7938
301-435-0422

Scientific Review Administrator, Program Project Review
Two Rockledge Centre, Room 7208
6701 Rockledge Drive
Bethesda, Maryland 20892-7924
301-435-0303

Deputy Director, Grants Operations Branch
Two Rockledge Centre, Room 7160
6701 Rockledge Drive
Bethesda, Maryland 20892-7926
301-435-0166

APPENDIX

TABLE 1

Detailed Budget for the First 12-Month Period

Personnel (Applicant organization only)            Time/Effort