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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:
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
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.
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.
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.
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).
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.
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:
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.
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.
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.
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.
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.
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.
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>
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.
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.
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.
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).
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.
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.
A22. Yes, the Progress report is included within the page limitations of the Research Strategy section of any Projects or Cores in renewal applications.
A23. No, the Progress Report Publication List is uploaded as a separate document in ASSIST and is not included in the page limitations.
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.
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.
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:
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.
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?
A28. Please refer to the NHLBI Funding and Operating Guidelines.
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