Guidelines for Program Project Grants

Q1. What are the requirements for a P01 application?

A1. It is critical that your application adhere to the requirements of the funding opportunity announcement (FOA). Failure to do so may result in your application being returned without review. Specifically, these requirements are:

• The direct cost budget caps of $1,515,000 for traditional (no ESI Project) and $1,765,000 for a minimum 4-project P01 containing an ESI-led Project must be adhered to in all requested years (no budget increases are allowed in any future year).
• Each Program Project Grant application must have a minimum of three distinct/individual Project Leaders. Although individual investigators are not precluded from leading more than one Project in a Program Project, justification must be provided for all such instances. In no case may one person serve as Project Leader on more than 2 Projects.
• The multi-PI mechanism is available only for the overall Program Director (PD/PI) position. Any multi-PI must direct his/her own project plus provide an additional 5% effort elsewhere in the application. Multiple leaders on Projects or Cores are not permitted.
• Project Leaders must devote a minimum of 20% effort (2.4 calendar months) to their Project (a consistent and sustained effort over the 12 month period). The overall Program Director must lead his/her own Project with the aforementioned minimum 20% (2.4 calendar months effort) plus devote a minimum additional 5% (0.6 calendar months) effort elsewhere in the Program. There is no minimum effort requirement for Core Leaders.
• Each proposed Scientific Core must contain an institutional letter from the departmental chair or dean indicating the necessity of the Scientific Core. The letter must confirm that the proposed Scientific Core does not duplicate existing institutional resources and describe existing related core facilities at the institution. A separate letter should be included for each proposed scientific core.
• Applications containing an ESI-led Project must include two separate letters from (a) sponsoring institution (Dean or Departmental Chair) and from (b) the Program Project Director (PD/PI) addressing the issues of commitment and leadership skills development as detailed in the FOA. These are 2 separate letters signed by 2 different people.

Q2. The PPG FOA lists two different types of applications: typical applications, with direct costs limited to $1.515 million per year, and applications containing an ESI-led project, limited to $1.765 million per year. What process will these applications go through to gain approval to submit?

A2. All PPG applications will go through the process for applications requesting $500,000 or more. Please refer to Part 2 Section IV of the FOA for further instructions on "Requests of $500,000 or more for direct costs in any one year." Please also see the NHLBI Policy for Applications with Direct Costs of $500,000 or More in a Single Year

Q3. I am considering submitting a Resubmission (A1). Do I need to go through the NHLBI process for applications requesting more than $500,000, including a staff consultation, before submitting?

A3. In most cases, Resubmission (A1) applications will not need to obtain a new staff consultation. This information is detailed under “Requests of $500,000 or more for direct costs in any year” in the FOA. However, if you plan to increase your direct costs requested in any year, for example with the addition of an ESI-led Project, you will need a new staff consultation. In addition, if you plan to make major changes to the application, for example if there is a change in scope or Project leadership, you may find it helpful to consult with NHLBI staff before submitting. Applicants are limited to one renewal (Type 2). No renewal (Type 2) applications beyond year 10 will be accepted.

Q4. When I am applying for a PPG Renewal (Type 2), do I need to go through the NHLBI process for applications requesting more than $500,000, including a staff consultation, before submitting?

A4. A4. In most cases, Renewal applications will not need to obtain a new staff consultation. This information is detailed under “Requests of $500,000 or more for direct costs in any year” in the FOA. However, if you plan to increase your direct costs requested in any year, for example with the addition of an ESI-led Project, you will need a new staff consultation. In addition, if you plan to make major changes to the application, for example if there is a change in scope or Project leadership, you may find it helpful to consult with NHLBI staff before submitting. Applicants are limited to one renewal (Type 2). No renewal (Type 2) applications beyond year 10 will be accepted.

Q5. My PPG application contains a second tier consortium/subcontract. Are facilities and administrative costs for the second tier consortium included in the direct costs?

A5. Yes, facilities and administrative costs for second tier consortium / third tier award (subcontract of a subcontract) are included in the direct costs. These costs must be within the PPG budget cap.

Q6. What amount of effort is required by Project Leaders in a PPG?

A6. The Project Lead must devote a minimum of 2.40 calendar months (20% effort) to the Project. If the Project Lead is also a PD/PI for the Overall Program, they must devote a minimum of 5% effort to one other component (e.g., another Project or a Core) for a total minimum of 3.0 calendar months (25% effort).

Q7. I am planning on submitting a PPG application with an ESI-led Project. Will my application, or the ESI-led Project, be reviewed any differently than a standard/typical PPG application?

A7. In general, no. ESI-led Projects, and PPG applications that include an ESI-led Project, will be reviewed with the same review criteria and general scoring system as standard/typical applications. There will, however, be additional review questions under the "Investigator" and "Environment" criteria for the ESI-led Project. In addition, letters of institutional support will be required to demonstrate that the ESI Project Leader is an independent investigator, and that the PPG will provide an adequate opportunity for leadership mentoring.

Q8. How will the independence of a proposed ESI Project Lead be assessed?

A8. Reviewers will use a combination of information to assess ESI Project Leader independence, including the biosketch, research background, letters of support, and available resources. All ESI projects must include a letter from the Overall Program Director and a letter from the sponsoring institution demonstrating commitment to the candidate’s leadership development and providing assurance that the research facilities, resources, and development opportunities, including faculty capable of productive collaboration with the candidate, will be available for the candidate’s career development and research programs. Evidence for independence may include:

• The candidate has a full-time faculty position.
• The candidate received a start-up package for support of his/her independent research.
• The candidate has research space dedicated to his/her own research.
• The candidate may attend faculty meetings, be the responsible supervisor for graduate students, and/or hire technical support or postdoctoral fellows.
• The candidate is eligible to apply for independent research funding as the PD/PI of an NIH research grant.

Q9. I am an ESI, and plan to be included as a Project Lead for an upcoming PPG application. If awarded, will I lose my ESI/New Investigator status?

A9. No. A PPG Project is not an independent research grant. Therefore, serving as a Project Leader, but not Program Director/Principal Investigator, in a PPG grant will not impact the investigator’s New Investigator or ESI status.

Q10. Can I replace an ESI Project Lead after Review or after Award of my PPG?

A10. Post-award changes to ESI Project Lead will be handled on a case-by-case basis. However, the replacement must be an ESI. In most cases, if an ESI Project Lead is replaced after review or award of a PPG application, the awarded budget will be adjusted so that it does not exceed $1.515 million/year direct costs. Replacement of any Key Personnel, including Project Leads, requires prior approval of NHLBI.

Q11. I originally submitted my (A0) application as a three-Project PPG. For the Resubmission (A1), I would like to include a fourth ESI-led project. Can I submit this as an A1 application, with the larger budget?

A11. Yes, however your letter granting you permission to submit was based on the structure and budget of the Program as proposed. Significant deviations from that proposal and/or budget would require a new staff consultation and a new letter. In addition, you might want to discuss this with your Program Officer, as significant changes to your Program may warrant a New application.

Q12. I am submitting a Renewal (Type 2) PPG application. Can I add an ESI-Led Project with the increased budget in my renewal?

A12. Yes, however your letter granting you permission to submit was based on the structure and budget of the program as proposed. Significant deviations from that proposal and/or budget would require a new staff consultation and a new letter. In addition, you might want to discuss this with your Program Officer, as significant changes to your Program may warrant a New application.

Q13. Can I include an ESI-Led Project in a PPG application that includes only two other Projects if I adhere to the $1,515,000 direct costs per year budget cap?

A13. No. To include an ESI-Led Project, the Program must include at least 3 other Project Leaders who have demonstrated the ability to lead an R01, or R01-equivalent, grant. Applicants may only include an ESI-Led Project if there is a minimum of 4 total Projects comprising the Program.

Q14. I am currently PI on a PPG that is past its tenth year. I would like to submit a Renewal (Type 2) PPG application to continue this Program. Can I do that?

A14. No. The new PPG FOA limits PPG awards to one competitive Renewal. This will allow for a total award period of 10 years maximum for a Program. However, you may always submit a New PPG application, even if it is a continuation of an existing scientific Program.

Q15. I submitted a PPG application containing four Projects, one of which is led by an ESI, and we requested $1,765,000/year direct costs. After we submitted the PPG application, the ESI lost ESI status due to award of an R01 or time after terminal degree. Can we still receive the requested budget if the application is awarded?

A15. Yes. Applications will be assessed at time of submission for ESI eligibility. If the application contains at least four projects, one of which is led by an ESI at time of submission, NHLBI will consider it compliant with requirements for the higher budget when making funding decisions./p>

Q16. I submitted a PPG application containing four Projects, one of which is led by an ESI, and we requested $1,765,000/year direct costs. After we submitted the PPG application, the ESI lost ESI status due to award of an R01 or time after terminal degree. We are now considering submitting a Resubmission (A1) of the PPG application. Can we request the higher budget, even though the Project is no longer led by an ESI?

A16. Yes. The application can be submitted as a Resubmission (A1) with the increased budget, provided the ESI-led project retains the same Project Lead. This remains true even if the ESI Project Lead has lost ESI status in the interim. Eligibility is determined at submission of the original (A0) application.

Q17. I was awarded a PPG with four Projects, one of which is led by an ESI, with a budget of $1,765,000/year direct costs. After 5 years of support, we would like to submit a Renewal (Type 2) application. Will we be able to submit an application with the increased budget if the ESI Project Lead loses ESI status due to award of an R01 or time after terminal degree in the intervening years?

A17. No. For an application to be eligible for the increased budget, one of the four Project Leads must be an ESI at the time of submission of the Renewal (Type 2 A0) application. The ESI Project Lead in the Renewal application need not be the original ESI Project Lead.

Q18. I do not plan to include an Administrative Core in my application. How will reviewers know how I plan to organize and lead my PPG?

A18. Applicants that do not propose an Administrative Core must provide the required information in the Overall Program component of their application. Please refer to Part 2 Section IV of the FOA for information on what needs to be included in the PHS 398 Research Plan for the Overall Program if an Administrative Core is not included.

Q19. How will justification of a Scientific Core be assessed?

A19. Any proposed Scientific Core must include an institutional letter from the Department Chair/Division Head/Dean documenting the need for this Scientific Core and include information regarding other related Core facilities that are currently provided at the Institution. This is to provide the review panel with adequate information to determine if the Scientific Core is necessary, or if the work can be accomplished through other means at the institution (for example, included as a fee-for-service within the Project budgets).

Q20. Can I include an NIH-defined clinical trial as part of my PPG application?

A20. Clinical trials, excluding Phase III clinical trials, are permitted as part of a PPG application. However, NIH is imposing new policies on applications containing clinical trials. You are strongly encouraged to familiarize yourself with the new NIH policies before applying. Please see https://grants.nih.gov/ct-decision/index.htm  for more information on submitting applications containing clinical trials.

Q21. I was recently awarded an NHLBI R35 grant. Can I apply for an NHLBI PPG?

A21. Yes, an R35 PI can serve either as a PD/PI or Project Lead of a PPG application. However, the R35 PI must document any overlap in the Just-In-Time submitted for that application (per standard NIH rules) and explain how potential overlap due to the nature of the R35 will be mitigated. Before applying, investigators should consider whether the proposed research could be accomplished under the R35 award.

Q22. Is the Progress report for Projects/Cores included in the page limitations of my renewal application (Type 2)?

A22. Yes, the Progress report is included within the page limitations of the Research Strategy section of any Projects or Cores in renewal applications.

Q23. Is the Progress Report Publication List for Projects/Cores included in the page limitations of my renewal application (Type 2)?

A23. No, the Progress Report Publication List is uploaded as a separate document in ASSIST and is not included in the page limitations.

Q24. If the Vertebrate Animal Sections of the Projects fully describe the involvement of live vertebrate animals, do we need to include a vertebrate animal section in the Cores as well?

A24. You can refer to the description provided in the Projects, but it is advised that you upload a statement in place of uploading the Vertebrate animal descriptions for the Core, to direct reviewers to the correct place for the information. An exception would be a Vertebrate Animal Core, in which this information might be expected in the Core.

Q25. If the Protection of Human Subjects Sections of the Projects fully describe the involvement of human subjects, do we need to include a Protection of Human Subjects section in the Cores as well?

A25. You can refer to the description provided in the Projects, but it is advised that you upload a statement in place of uploading the Protection of Human Subjects descriptions for the Core, to direct reviewers to the correct place for the information. An exception would be a Clinical Core, in which this information might be expected in the Core.

Q26. How are PPGs reviewed at NHLBI?

A26. All NHLBI Program Project Grant applications are reviewed through a two-step process by a Tailored Review Committee and by the Heart, Lung, and Blood Program Project Review Committee (HLBP) prior to review by the NHLBI Advisory Council.

The Tailored Review Committee is composed of scientific peers convened to review a Program Project Grant application in their area(s) of expertise. The Tailored Review Committee will:

• Provide an overall assessment of each Project based on its intrinsic and scientific merit within the field and provide a percentile descriptor ranking score of that Project broken down into seven categories (i.e., top 1% of projects within the field, 1%-10% of projects within the field, 10-20% of projects within the field, 20-30% of projects within the field, 30-40% of projects within the field, 40-50% of projects within the field, and 50% or less of projects within the field).
• Assign numerical scores to each scored criterion and provide written critiques of the strengths and weaknesses of the scored review criteria.
• Rate each Core as "Recommended" or "Not Recommended" based on whether it is essential and justified for the proposed research and has the capability to fulfill the proposed function.
• Assess whether the proposed budget is appropriate.

The HLBP considers the review reports from the Tailored Review Committee, makes recommendations, and assigns an overall impact score to each application. It may not change an individual Project assessment assigned by the Tailored Review Committee, but it is asked to provide written comments to be included in the summary statement if HLBP's impression of project merit significantly differs from the Tailed Review Committee.

Q27. What is the new review criterion "Integration?"

A27. This is an additional scored criterion that will evaluate the following questions for the Projects: How well-integrated is the Project within the Program? Does inclusion of this Project within a Program offer distinct advantage or scientific gain over pursuing the Project independently? Is the Project interrelated and synergistic within the overall Program? How well does the Project fit into the overall theme of the Program?

Q28. How will funding decisions be made?

A28. Please refer to the NHLBI Funding and Operating Guidelines.

For more information:

Notice of Intent to Publish a Funding Opportunity Announcement for NHLBI Program Project Applications (P01)

Allowable Requested Direct Costs for Program Project Grants (P01s)

NHLBI Policy for Applications with Direct Costs of $500,000 or More in Any One Year

NHLBI Two-Step Review Process for Program Project Grant Applications

Heart, Lung, and Blood Program Project Review Committee Rosters

NHLBI Funding and Operating Guidelines

NIH Early Stage and Early Established Investigator Policies (contains definition of ESI)

New NIH Clinical Trials Policy

Policy on Reinstatement of Program Project (P01) Subprojects