NHLBI Program Project Grants (P01) is a funding opportunity from the National Heart, Lung, and Blood Institute (NHLBI/NIH) that supports large-scale, investigator-initiated research programs addressing heart, blood vessel, lung, blood, and sleep disorder biology and disease. Programs must include a minimum of three interrelated research projects sharing common scientific goals.

Eligible applicants include universities, medical colleges, and domestic research centers. Awards support up to $1,515,000 in direct costs per year, with a deadline of September 25, 2026. Clinical trials are optional under this mechanism.

PAR-24-065: NHLBI Program Project Applications (P01 Clinical Trials Optional) This funding opportunity was updated to align with agency priorities. Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Heart, Lung, and Blood Institute ( NHLBI ) Funding Opportunity Title NHLBI Program Project Applications (P01 Clinical Trials Optional) P01 Research Program Projects March 31, 2025 - This funding opportunity was updated to align with agency priorities.

Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. April 04, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice NOT-OD-24-084 August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023.

See Notice NOT-OD-22-198 . August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy. See Notice NOT-OD-22-189 .

Funding Opportunity Number (FON) Companion Notice of Funding Opportunity See Section III. 3. Additional Information on Eligibility .

Assistance Listing Number(s) 93. 838, 93. 837, 93.

233, 93. 839, 93. 840 Notice of Funding Opportunity Purpose This Notice of Funding Opportunity (NOFO), issued by the National Heart, Lung, and Blood Institute (NHLBI) invites submission of investigator-initiated Program Project (P01) applications.

The proposed programs may address scientific areas relevant to the NHLBI mission including the biology and diseases of the heart, blood vessels, lung, and blood; blood resources; and sleep disorders. Programs may also include implementation science, health disparities, and translation research that addresses the mission of the Institute.

Each application submitted in response to this NOFO must include at least three related research projects that share a common central theme, focus, and/or overall objective. Higher budgets may be requested for applications that include at least four projects, one of which includes an Early Stage Investigator as Project Leader.

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) 60 days prior to the application due date The following table includes NIH standard due dates marked with an asterisk. Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed All applications are due by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date. Required Application Instructions It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide , except where instructed to do otherwise (in this NOFO or in a Notice from the NIH Guide for Grants and Contracts ).

Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review. There are several options available to submit your application through Grants. gov to NIH and Department of Health and Human Services partners.

You must use one of these submission options to access the application forms for this opportunity. Use the NIH ASSIST system to prepare, submit and track your application online. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.

gov and eRA Commons to track your application. Check with your institutional officials regarding availability. Part 1.

Overview Information Part 2. Full Text of Announcement Section I. Notice of Funding Opportunity Description Section II.

Award Information Section III. Eligibility Information Section IV. Application and Submission Information Section V.

Application Review Information Section VI. Award Administration Information Section VII. Agency Contacts Section VIII.

Other Information Part 2. Full Text of Announcement Section I.

Notice of Funding Opportunity Description The National Heart, Lung, and Blood Institute (NHLBI) Program Project Grant (P01) supports research related to fundamental processes and diseases of the heart, blood and lymphatic vessels, lungs, and blood, including transfusion medicine, blood resources, and sleep disorders and other programs including implementation science, health disparities, and translation research that address the mission of the Institute.

This NOFO requires a minimum of three interrelated research projects that investigate a complex biomedical theme or research question. The projects may be supported by scientific cores, if justified, to facilitate economy of effort, space, and equipment.

The NHLBI provides support for Program Project Grants (PPGs) in the belief that collaborative research efforts can accelerate the acquisition of knowledge more effectively than a simple aggregate of research projects that have no interaction or thematic integration. NHLBI is particularly interested in encouraging new scientific directions in PPGs.

Use of the P01 mechanism is viewed as an opportunity to attract and include scientists who traditionally have not been supported by the NHLBI. Further, the PPG environment presents an opportunity for emerging scientific leaders to gain insight into how to lead a successful scientific program, and applicants will have the opportunity to include a project led by an Early Stage Investigator (ESI).

All projects in the Program must be interrelated and have objectives that address a central theme within the scientific mandate of the NHLBI. This Notice of Funding Opportunity (NOFO), issued by the NHLBI, invites PPG applications that address the mission of NHLBI as outlined in the Purpose section.

Investigators are encouraged to visit the NHLBI website for additional information about the research mission and high-priority research areas of the NHLBI. The purpose of the Program Project approach is to support integrated, collaborative research programs that have a well-defined, central research focus or objective. Applications must include a minimum of three individual research projects that contribute to the Program objective.

Since the NHLBI is interested in supporting new, innovative research through the Program Project, 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 application is funded.

Each individual research Project should reflect a distinct, separate, scientifically meritorious research effort led by an independent investigator, the Project Leader. In addition, the individual Projects should be clearly interrelated and synergistic so that the research ideas, efforts, and outcomes of the Program as a whole will offer a distinct advantage over pursuing the individual projects separately.

As part of this integration, the PD/PI (or each of the Multiple PD(s)/PI(s)) must also serve as the Project Leader of one of the Projects and each awarded Program Project must have a minimum of three distinct/individual Project Leaders. In addition to individual research Projects, applicants may propose an Administrative Core and one or more shared Scientific Core(s) as necessary to facilitate the proposed research Projects.

It is expected that each Scientific Core will be utilized by two or more Projects within the Program. Any proposed Scientific Core, if justified, is expected to be considered essential to conduct the Program and should not duplicate existing institutional resources. Responses to Frequently Asked Questions (FAQs) are available at: https://www.

nhlbi. nih. gov/grants-and-training/policies-and-guidelines/program-project-grants .

Applications Not Responsive to this NOFO Phase III and Phase IV Clinical Trials are considered non-responsive for this NOFO and will be withdrawn. Applications not responsive to this NOFO will not be reviewed. See Section VIII.

Other Information for award authorities and regulations. Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs. Section II.

Award Information Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. Application Types Allowed Applicants are limited to one renewal (Type 2). No renewal (Type 2) applications beyond year 10 will be accepted to this NOFO.

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO. Optional: Accepting applications that either propose or do not propose clinical trial(s).

Need help determining whether you are doing a clinical trial? Funds Available and Anticipated Number of Awards The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

New (Type 1) and Renewal (Type 2) applications must limit their budget request to $1,515,000 in direct costs (excluding first-tier subcontract Facilities and Administrative [F&A] costs) or less in each year.

If an ESI-led Project is included and the application contains a minimum of four Projects, applications must limit their budget request to $1,765,000 in direct costs (excluding first-tier subcontract Facilities and Administrative [F&A] costs) in each year (with a minimum of $250,000 per year in direct costs for the ESI-led Project). Project budgets should reflect the actual needs of the proposed project.

No annual increases in noncompeting years may be requested. Facilities and administrative costs requested by first tier consortium participants are not included in the direct cost (see NOT-OD-05-004 ). However, facilities and administrative costs for second tier consortium are included in the direct cost.

Applicants should 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. Equipment is included in the budget ceiling. Final decisions on equipment requests will depend on the nature of the justification and the Institute's fiscal situation.

The maximum project period is 5 years. The scope of the proposed project should determine the project period. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.

Section III.

Eligibility Information Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit Organizations (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) Eligible Agencies of the Federal Government U.S. Territory or Possession Independent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Non-domestic (non-U.S.) Entities (Foreign Organization) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement , are allowed. Applicant organizations must complete and maintain the following registrations as described in the How to Apply- Application Guide to be eligible to apply for or receive an award.

All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.

3. 9. 2 Electronically Submitted Applications for additional information.

System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually . The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.

NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM. gov registration process.

The same UEI must be used for all registrations, as well as on the grant application. eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants. gov registration; all registrations must be in place by time of submission.

eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application. Grants. gov Applicants must have an active SAM registration in order to complete the Grants.

gov registration. Program Directors/Principal Investigators (PD(s)/PI(s)) All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons.

If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator) Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

The PD(s)/PI(s) are expected to be a research scientist(s) of recognized stature in his/her scientific discipline with the demonstrated ability to ensure quality control, administrative oversight, and integration of all components of a Program. The PD(s)/PI(s), Project Leaders, and Core Leaders are expected to be fully established at their institution at the time of submission of the application.

Additionally, Project Leaders are expected to have demonstrated the ability to lead an R01, or R01-equivalent, grant. The expectation of demonstrated ability to lead an R01, or R01 equivalent, grant does not apply to ESI Project Leaders or Core Leaders. This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.

2- Definitions of Terms. 3. Additional Information on Eligibility Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time per NIH Grants Policy Statement Section 2. 3. 7.

4 Submission of Resubmission Application . This means that the NIH will not accept: A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application. A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.

An application that has substantial overlap with another application pending appeal of initial peer review (see NIH Grants Policy Statement 2. 3. 9.

4 Similar, Essentially Identical, or Identical Applications ). Section IV. Application and Submission Information 1.

Requesting an Application Package The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this NOFO. See the administrative office for instructions if planning to use an institutional system-to-system solution.

2. Content and Form of Application Submission It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide , except where instructed in this notice of funding opportunity to do otherwise and where instructions in the Application Guide are directly related to the Grants. gov downloadable forms currently used with most NIH opportunities.

Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1.

Overview Information , prospective applicants are asked to submit a letter of intent that includes the following information: Descriptive title of proposed activity Name(s), address(es), and telephone number(s) of the PD(s)/PI(s) Names of other key personnel Participating institution(s) Number and title of this funding opportunity The letter of intent should be sent to: Program Project Review Office Director, Office of Scientific Review National Heart, Lung, and Blood Institute All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed.

Component Type for Submission Opportunity-Specific ESI Led Project Opportunity-Specific ESI Led Project Instructions for the Submission of Multi-Component Applications The following section supplements the instructions found in How to Apply- Application Guide and should be used for preparing a multi-component application.

The application should consist of the following components: Administrative Core: optional; maximum of 1 ESI-Led Project: optional; maximum of 1 When preparing the application, use Component Type Overall . All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424(R&R) Cover (Overall) PHS 398 Cover Page Supplement (Overall) Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component. Research & Related Other Project Information (Overall) Follow standard instructions.

Project/Performance Site Locations (Overall) A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Research and Related Senior/Key Person Profile (Overall) Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this NOFO) for the entire application. All PD(s)/PI(s) must be the Project Leader of one of the component Projects.

Note that multi-PD(s)/PI(s) are allowed for the Overall Program, however applicants must provide strong justification for the use of a multi-leadership model for the Overall Program. Multi-PDs/PIs for component Projects or Cores are not permitted in response to this NOFO.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission. The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission. PHS 398 Research Plan (Overall) Introduction to Application: For Resubmission applications, an Introduction to Application is required in the Overall component. Specific Aims: Describe the specific aims for the Overall Program.

List the goals of the research and summarize expected outcomes. Research Strategy: Describe the significance, innovation, and approach of the overall application and highlight the Program's conceptual unity by describing the scientific problems to be addressed and laying out a broad research strategy to address them.

The Program Project 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 that contribute to the integrating theme. The theme of a proposed Program Project should be established in the first few sentences of this section.

It should include a description of the major research objectives and strategic plan. Explain how the proposed Projects and shared Scientific Cores (if proposed and justified) will be coordinated and work together to address the overall goals and aims of the Program more effectively than if the Projects were conducted independently.

Describe 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, to describe how the Projects are interrelated, and to explain how the proposed Program Project would enable the stated objectives of the proposed research to be addressed more efficiently and effectively than a group of individual research project grants.

Summary Report of Progress: For renewal applications only, include a progress report that summarizes the aims and accomplishments of the Program during the prior funding period. See the SF424 instructions for details about what to include in the progress report. If a project from the prior funding period is being discontinued, explain in the overall progress report.

A progress report is required for each research Project and Core(s) in the respective components of the application.

The composite summary/progress report must include: a brief summary of major accomplishments that can be attributed to the Program Project and a brief explanation of how they relate to the stated objectives of the Program; a list of changes, if any, in the professional staffing since the last competitive review; a list of research Projects and Core(s), 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; and a list of research Projects and Cores in the current Program Project.

Identify each as a "new" or "continuing" component. In addition, if an Administrative Core is not proposed, applicants must provide the information outlined in the Administrative Core Research Strategy section. Letters of Support: Attach letters of support relevant to the Program as a whole (e.g., letters of institutional support).

Letters of support relevant to specific Projects or Cores should be attached in the relevant Project or Core Research Plan forms. Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component.

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions: All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan.

All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. Only one Data Management and Sharing Plan is required per application. Only limited items are allowed in the Appendix.

Follow all instructions for the Appendix as described in How to Apply- Application Guide ; any instructions provided here are in addition to the Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall) When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions: If you answered Yes to the question Are Human Subjects Involved?

on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components.

To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components. Study Record: PHS Human Subjects and Clinical Trials Information All instructions in the SF424 (R&R) Application Guide must be followed.

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply- Application Guide must be followed. PHS Assignment Request Form (Overall) All instructions in the How to Apply- Application Guide must be followed.

When preparing your application, use Component Type Admin Core. All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted. Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component. SF424 (R&R) Cover (Administrative Core) Complete only the following fields: Type of Applicant (optional) Descriptive Title of Applicant’s Project Proposed Project Start/Ending Dates PHS 398 Cover Page Supplement (Administrative Core) Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administrative Core) Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question. Project Narrative: Do not complete.

Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components. Project /Performance Site Location(s) (Administrative Core) List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries. Research & Related Senior/Key Person Profile (Administrative Core) In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.

In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component. Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.

If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used. For this NOFO, only one Core Lead may be designated for the Administrative Core. Multiple Core Leads are not permitted.

Applications that propose multiple Core Leads for the Administrative Core will be considered non-compliant and will not be peer reviewed. Budget (Administrative Core) Budget forms appropriate for the specific component will be included in the application package. Include budget information for Data Management and Sharing Costs, if applicable to the Administrative Core.

While there is no minimum effort required, the Core Lead should dedicate appropriate time and effort commensurate with the complexity of the Core’s function. Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Administrative Core) Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for the Administrative Core component. Specific Aims: List in priority order, the broad, long-range objectives and goals of the proposed Administrative Core.

In addition, state the Core’s relationship to the proposed Program’s goals and how it is related to the component Research Projects and Core(s) in the application. Research Strategy: If an Administrative Core is not proposed, the following must be addressed in the Research Strategy of the Overall Program section. The institution and the PD/PI are responsible for the application and collaborative research activities.

Explain the plans for organizational and administrative management of the entire Program, and for coordination and communication within the Program. Explain the methods that will be used for monitoring progress in the Projects and effective use of the shared Scientific Cores.

Explain the plans for internal quality control of on-going research, management of day-to-day program activities, management of contractual agreements (if applicable), and a plan for resolution of disputes.

Describe how the Core Lead’s administrative, management, and leadership capabilities adequately provide for: internal quality control of on-going research, management of day-to-day program activities, and management of contractual agreements.

Describe communication and cooperation among program leaders and/or program investigators, plans for resolution of disputes, development of scientific meetings and allocation of funds as applicable. Chain of Responsibility : Describe in detail, and by diagram, if appropriate, the chain of responsibility for decision making and administration, beginning with the PD/PI and including the leaders of the research Projects and Cores.

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 should have plans for both an External Advisory Board and an Internal Advisory Board.

For an External Advisory Board, describe the expertise and responsibilities of your potential Board members. If submitting a new application, do not contact, recruit, or name potential members of the External Advisory Board.

New Program Project Grant applications should not constitute an External Advisory Board prior to or during the review of their application because individuals identified in an application cannot participate in its peer review. Renewal applications should provide the names of current and former members. The External Advisory Board should consist of two or three named advisers committed to the evaluation of the Program.

Two or three additional advisers may be added once the progress of the Program and its needs are clearer. The Internal Advisory Board should consist of three to five members outside of the Program but within the applicant institution who are able to assist in frequent, ongoing oversight.

Specific Managerial Responsibilities : Indicate who would be responsible for assisting the PD/PI with day-to-day administrative details, Program coordination, planning, and evaluation of the Program.

Relation of the Program Project Grant to the Administration of the Applicant Institution : Describe the relationship between the proposed Program Project and other existing research, academic, and administrative units of the applicant institution such as schools, centers, institutions, departments, and central administration.

Designation of Replacement for PD/PI : Describe the procedure for selecting a proposed replacement for the PD/PI, should the need arise. The NHLBI must approve any request to replace the PD/PI. Administrative Core Progress : A progress report must be provided for