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Frequently Asked Questions for RFA-HL-07-005: NHLBI Exploratory Program in Systems Biology (R33) (and HL-06-004)

Questions for August 2006:

Q: How many pages are allowed in the research plan? Is the total number 15, 25, or 30?
A: The maximum number of pages allowed by the entire cluster to describe the Research Plan (Sections A – D) is thirty (30) pages.

The Cluster must have all 30 pages of the Research Plan (Sections 2 - 5 in the SF 424 R&R Form Set) located entirely in the Lead PI’s Application. The Lead PI's application should note which PI will undertake various portions of the research described in the research plan.

Collaborating PI applications must contain all relevant administrative pages, including: Face Page, Description, Performance sites, Key Personnel, Table of Contents, Budget (detailed), Biographical Sketch, Resources, Human Subjects Research, Vertebrate Animals, etc. For Sections 2 - 5 of the Research Plan, Collaborating PIs should only put in a reference to the Lead PI's application, noting their name and the application title (which should be the same in all applications in the cluster).

Q: How should the summary budget for the entire cluster be submitted with the SF 424 R&R form set?
A: Separate from the research budget for their own application, the Lead PD/PI must also submit an overall budget for the entire cluster project including all collaborating applications and subcontracts on the SF424 (R&R) form “Other Project Information Component,” under section 11 “Other Attachments.” This attachment will be uploaded as a PDF document. If you have further questions about the format of the overall budget, please contact either Dr. Pankaj Qasba at Email: qasbap@nhlbi.nih.gov or Dr. Jennie Larkin at Email: LarkinJ2@nhlbi.nih.gov.

TOPICS:
[General]    [Grant Application]    [Budget]    [Review]    [Contacts] 

General

Q: What is the definition of Systems Biology?
A: For the purposes of this RFA, systems biology is defined as an approach to explaining and predicting complex cellular and physiological phenomena of living organisms in terms of underlying physical and chemical processes and accompanying feedback regulations at molecular, cellular, tissue, or whole organ levels. This systems biology approach will combine mathematical modeling and simulation to complement the traditional empirical and experimental approach of biomedical research. Mathematical modeling and simulation may range from the molecular scale through to organ scale models. These models and simulations will be driven by empirical observations and will generate specific, explicitly testable predictions that will enable refinement of the models in response to experimental validation. This iterative development of models and experiments is a critical feature of the systems biology research supported by this RFA.

Q: Could you clarify the scope of experimental model systems in responsive applications?
A: As this RFA aims to improve understanding of physiology and pathophysiology underlying cardiovascular, lung, blood, and sleep function, the main thrust of applications must be to understand the functioning of these tissues and organs. Applications may include neurobiological regulation of heart, lung, or blood function, such as neural control of respiration or blood pressure. Applications using cell culture for experimental validation of model predictions are limited to primary cell cultures. Applications based on immortalized cell lines would be non-responsive as would applications based exclusively on non-mammalian model systems.

Q: This RFA requires both computational and biomedical/experimental investigators as collaborating PIs. Who is a computational researcher?
A: The computational PI will be the member of the team with key responsibility for modeling and simulation approaches used in the research. These simulations should be quantitative and should mathematically describe the underlying physical or chemical processes or accompanying feedback regulations at molecular, cellular, tissue, or whole organ levels. Applications would be deemed non-responsive if their mathematical component is limited to statistical analyses of data rather than quantifying underlying physical and chemical processes and accompanying feedback regulations at molecular, cellular, tissue, or whole organ levels.

Q: What are the receipt dates for this RFA?
A: Contingent on the availability of funds and programmatic priorities, the anticipated receipt dates for this initiative are September 25, 2006, and September 25, 2007.

Q: If my application is not funded, can I submit an amended application?
A: Yes, one amended application will be accepted for applications submitted on the first or second receipt dates. Applications submitted on the first receipt date (March 10, 2006) may submit an amended application to either the second (September 25, 2006) or third (September 25, 2007) receipt dates. Applications first submitted on the second receipt date (September 25, 2006) may submit an amended application on the third receipt date (September 25, 2007).

Q: This RFA describes funding each cluster grant for a three year period, with the entire program spanning a five year period. If the program is successful, will it be continued beyond the termination of this program?
A: This program uses the exploratory and developmental R33 mechanism, which is not renewable. By the end of the award, successful groups should have sufficient results and data to be competitive for new, investigator-initiated applications. NHLBI will evaluate the progress of this program in assembling multidisciplinary collaborative teams, their success at building predictive models and in combining both quantitative and experimental approaches. Based upon this assessment, NHLBI will explore funding opportunities to further systems biology analysis of complex heart, lung, blood, and sleep diseases and disorders.

Q: What physical scale(s) should research be conducted on?
A: Applications may propose research at any scale, spanning the range from molecules to genes to the physiological function of whole organs and regulatory systems. Proposals for multi-scale modeling that directly and explicitly address how to link multiple scales (two or more scales from the molecular to organ levels) within a model are strongly encouraged. One of the review criteria (under the heading “Approach”) is “How well does the project integrate information across multiple scales?”

Grant Application

Q: Must we submit the application as a cluster, with a Lead PI and Collaborating PI(s), or can we just submit a single application with sub-contracts?
A: Applications must be submitted in the specified cluster format, with Lead PI and Collaborating PI(s) applications. Those that do not conform to this format will be deemed non-responsive.

Q: What differentiates the Lead PI from the Collaborating PI(s)?
A: The Lead PI will be the point of contact between NHLBI and participants in the cluster. The Lead PI’s application must contain relevant information for the overall proposal, including a management plan, composition of the scientific steering committee, and timeline and milestones.

Q: What is in the Lead PI’s application?
A: The Lead PI will be the point of contact between NHLBI and participants in the cluster. The Lead PI’s application must contain relevant information for the overall proposal, including a management plan, composition of the scientific steering committee, and timeline and milestones.

  • A face page with information only regarding the lead PI’s application.
  • Complete categorical budget information with justification for the initial and future years for the lead PI’s application.
  • A total overall budget for the cluster, including all collaborating grants and subcontracts, for each year of support requested.
  • An overview of the cluster’s scientific program that couples all study components to the project aims. The synergy achieved from interactions between collaborating applications should be clearly presented. The lead PI application must include the Specific Aims for the overall cluster as well as detailed Specific Aims for their own project.
  • The Lead PI’s application will also include the Management Plan, the Timeline and Milestones, the Background/Significance, the Preliminary Studies, and the Research Design and Methods for the overall cluster.
  • A management plan that specifies the organizational structure with the roles and responsibilities of the lead and collaborating PIs and other key individuals. This management plan must include descriptions of the organizational structure of the collaborative partnership that clearly defines the collaborative team and relationships among the various components.  The project size, structure, and mode of operation should match the needs and scope of the proposed research.
  • Plans for a scientific steering committee consisting of those individuals identified in the management plan that collectively represent the intellectual and technical leadership required to accomplish the approved scientific aims. Each application in the cluster must be represented on the steering committee. The lead PI’s application must identify the composition of the scientific steering committee, including the chair of the steering committee.  The steering committee chair need not be a PI on one of the component applications in the cluster, but their role and % effort must be documented.  In addition to regular steering committee meetings to discuss project status, problems, and directions, the steering committee may propose the reallocation of future year commitments within the cluster of collaborating grants, subject to NHLBI approval.
  • A timeline and a set of specific, quantitative milestones that are to be achieved by the end of the research. These milestones should define expected achievements critical to interoperability of the modeling and experimental components of the proposed research.

Q: What is in the Collaborating PI’s application?
A: The need and purposes for each collaborating application in the cluster must be carefully and completely described and justified. Collaborating PI applications must include the face page, complete categorical budget justifications, facility statements, and other administrative pages. Commitment from the principal investigators and business offices of each component application must be documented.

Q: Is there a minimum percentage effort for either Lead PIs or Collaborating PIs?
A: Yes. Each collaborative PI must devote a minimum of 20% effort during each year of the project, and the lead PI must commit an additional 5% effort toward the overall coordination and administration of the cluster. Thus, the Lead PI must commit at least 25% effort in each year.

Q: Is the Lead PI also the chair of the steering committee?
A: Not necessarily. The Lead PI may be the Chair of the Steering committee or another expert outside those named as investigators in the applications may be named as Chair of the Steering Committee.

Q: What is the page limit on the application and how does this apply to applications in a cluster?
A: The research plan in the Lead PI’s application and in all Collaborating PI applications in a cluster must total no more than 30 pages. These 30 pages may be divided between the lead PI and collaborating PI applications as best suits the needs of the investigators.

Q: Can an institution outside of the United States apply?
A: Yes, institutions from foreign countries are eligible to apply. Several special provisions apply to applications submitted by foreign organizations:

  • Charge back of customs and import fees is not allowed.
  • Format: every effort should be made to comply with the format specifications, which are based upon a standard US paper size of 8.5" x 11."
  • Funds for up to 8% administrative costs (excluding equipment) can now be requested (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-028.html)
  • Organizations must comply with federal/NIH policies on human subjects, animals, and biohazards.
  • Organizations must comply with federal/NIH biosafety and biosecurity regulations. See Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award."
  • Proposed research should provide a unique research opportunity not available in the U.S.

Q: Can an application have a subcontract to Foreign Institutions?
A: Yes.

Q: Regarding eligible institutions, are Canadian and Mexican Universities/research centers considered as “foreign”?
A: Canadian and Mexican institutions are considered to be foreign with respect to submitting an application in response to this solicitation. A foreign institution is defined as “an organization located in a country other than the United States and its territories that is subject to the laws of that country, regardless of the citizenship of the proposed PI.” This is defined in the Glossary Section of Part I of the NIH Grants Policy Statement, dated 12/03, and located on the Internet at address: http://grants1.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part2.htm#_Toc54600040.

Q: What CVs or biosketches need to be enclosed?
A: A NIH-type CV should be included for all key personnel, collaborators, and consultants.

Q: Is a letter of intent required?
A: No, but it helps the Institute staff to plan the review. Applicants are encouraged to send a letter of intent, which must be received by August 24, 2006 or August 24, 2007 and which should include the following information:

  • Descriptive title of proposed research
  • Name, address, and telephone number of the Principal Investigator
  • Names of other key personnel
  • Participating institutions
  • Number and title of this funding opportunity

Q: Can I personally deliver the application on the due date at NIH?
A: No, NIH no longer accepts applications in person; they must be submitted electronically.

Budget

Q: In the applications, do the budgets count towards the 30 page limit for the Research Plan?
A: No, because budget is not a part of the Research Plan .

Q: If an application in the cluster has a budget less than $250,000, can it be submitted as a modular budget?
A: No, a categorical budget is required.

Review

Q: How will NHLBI decide which applications to fund?
A: The decision to fund will be based on three criteria: the scientific merits of the projects described within an application, the availability of funds, and program priorities. These decisions are made at two levels of review. In the first level of review, applications are evaluated for scientific merit by a tailored committee known as a Special Emphasis Panel, or SEP. This committee is composed of biomedical and computational scientists and clinicians, like you. The committee is tasked with the difficult job of stratifying the applications received and identifying those it considers to be meritorious. It does this by assigning to each, a composite score that reflects the significance of the proposed research, the balance of experimental and computational approaches, the integration of the team and its ability to carry out the proposed studies. The committee’s critiques are incorporated into preliminary summary statements that are then made available to both the applicants and members of the National Heart, Lung, and Blood Advisory Council (NHLBAC). In addition to identifying the strengths of applications, the SEP is also asked to identify deficiencies/weaknesses of the various applications so that applicants may use these critiques if they choose to resubmit an amended application. The NHLBAC is composed of scientists, clinicians, and lay persons. It reviews all scored applications and makes recommendations to the Director of NHLBI regarding the scientific merits of each, as well as the applicability and validity of the first review. The final decision rests with the Director of NHLBI.

Q: Who convenes the review committee?
A: The Scientific Review Administrator (SRA) assigned to the review is responsible for selecting and recruiting the consultants that comprise the Special Emphasis Panel. For this RFA, persons working in or familiar with systems biology and the computational and experimental approaches will be recruited. The SRA will read all applications and select consultants based upon the aims, objectives, and keywords described in individual projects. Global areas of expertise, as well as specific project needs are also considered.

Q: Will different application in the same cluster receive different scores from review?
A: No. All applications in a cluster will receive the same score, but the summary statements will detail the strengths and weaknesses of each application in a cluster as well as the overall synergy achieved by the entire cluster.

For further information contact:

Jennie Larkin, Ph.D.
Division of Cardiovascular Diseases
National Heart, Lung, and Blood Institute
6701 Rockledge Dr.
Rockledge II, 9142
Bethesda, MD 20892
Telephone: (301) 435-0513
FAX: (301) 480-1335
Email: LarkinJ2@nhlbi.nih.gov

and

Pankaj Qasba, Ph.D.
Division of Blood Diseases and Resources
National Heart, Lung, and Blood Institute
6701 Rockledge Dr.
Rockledge II, room #
Bethesda , MD 20892
Telephone: (301) 435-0055
FAX: (301) 480-0867
Email:qasbap@nhlbi.nih.gov


Last updated: August 18, 2006

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