Department of Health and Human Services


Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of General Medical Sciences (NIGMS)

Funding Opportunity Title

NIGMS National Centers for Systems Biology (P50)

Activity Code

P50 Specialized Center

Announcement Type

Reissue of PAR-12-187

Related Notices

  • September 27, 2013 - See Notice NOT-GM-13-135. Correction of Instructions for the "Introduction to Application" in the PHS 398 Research Plan form.

Funding Opportunity Announcement (FOA) Number

PAR-13-351

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.859

Funding Opportunity Purpose

The National Institute of General Medical Sciences (NIGMS) invites grant applications from institutions/organizations proposing to establish Centers of Excellence in Systems Biology.  The goal of this initiative is to promote pioneering research, research training, and outreach programs focused on systems-level inquiries of biomedical phenomena within the NIGMS mission.  The description of the NIGMS mission can be found on the website, http://www.nigms.nih.gov

Key Dates
Posted Date

September 11, 2013

Open Date (Earliest Submission Date)

September 23, 2013

Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Date(s)

October 23, 2013; October 23, 2014, 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.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

March-April 2014; March-April 2015

Advisory Council Review

May 2014, May 2015

Earliest Start Date

July 1, 2014; July 1, 2015

Expiration Date

October 24, 2014

Due Dates for E.O. 12372

Not Applicable

** ELECTRONIC APPLICATION SUBMISSION REQUIRED**

NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to all requirements (both in the Application Guide and the FOA) 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.

You will be sent to ASSIST to prepare and submit your application. Problems accessing or using ASSIST should be directed to the eRA Commons Help Desk.
Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. 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. Funding Opportunity Description


Research Objectives

The purpose of this funding opportunity (FOA) is to promote the use of Systems Biology approaches for studying complex biological phenomena, where these phenomena are relevant to the NIGMS mission. The Centers of Excellence program is intended to facilitate pioneering research, research training, and outreach programs in this area and therefore stimulate the field as a whole. The NIGMS mission includes research portfolios in the areas of bioinformatics and computational biology, molecular and cell biology, biophysics, genetics and developmental biology, biological chemistry, pharmacology, anesthesiology, basic social and behavioral sciences, and human physiology in the areas of shock, trauma, burn, wound healing, inflammation, and multi-organ system failure (http://www.nigms.nih.gov/About/). NIGMS does not support research focused on diseases or organ systems that are the domain of other Institutes and Centers within the NIH (http://www.nih.gov). The modeling of emergence of infectious diseases, a systems-related area, is the subject of another NIGMS program (http://www.nigms.nih.gov/Initiatives/MIDAS).

Successful Centers will be characterized by unique, exceptional contributions to existing areas of systems biology research, and/or by extension of systems approaches into emerging areas of opportunity.

Background

"Systems biology" is viewed by the NIGMS as a conceptual framework for the analysis of complex biological systems. Such systems derive from interactions among many distinct components, in varying contexts. These systems exhibit properties, such as nonlinear dynamics and emergent behavior that cannot easily be inferred from studies of components in isolation. Systems biology relies on mathematical methods and computational models to generate hypotheses and to design new experiments. Iteration between theory and experiment is crucial. The quantity and quality of data required for these approaches often challenge current technologies, and development of new technologies, and cross-disciplinary collaborations, may be required. When applied to human health, systems biology can be a powerful tool to test hypotheses relevant to health, disease, and therapeutic interventions.

Medical, biotechnological, and other applications of biological knowledge increasingly depend on our ability to understand the principles undergirding system behavior at a granularity that permits efficacious experimental design, simulations, and predictions of system behavior under perturbation. Whether the goal is to comprehend basic physiology and disease processes, to identify specific targets for drug intervention, or to understand the basic biological principles governing pattern formation in development, the challenge is to achieve a level of understanding of network structure and dynamics that enables tests of predictive power. Predicting quantitatively how any complex system will behave under defined conditions is a challenge; for biological systems, this problem is particularly daunting.

Systems Biology continues to develop as an integrated experimental, informational, and computational science. It has benefited from advances in high-throughput "omics" technologies, microfluidics, and imaging, and is driven by innovations in mathematics, computational analysis and simulation. Biologists may now pay more attention to understanding how biological components work together to produce system behaviors rather than focusing exclusively on the properties of individual molecules and pathways, although the latter is foundational for such inquiries. The adoption of a systems approach is providing new knowledge in many areas of biomedical research including cell motility and signaling networks, global metabolic fluxes, and responses to drugs (and guidance in their development). New, fundamental rules governing systems behavior at various organizational levels – and how these levels are integrated - are emerging from these studies. However, there continue to be significant conceptual, technological, and cultural challenges in systems biology research. It is the purpose of this initiative to promote innovative responses to these challenges.

Conceptual Challenges. Systems biology is an interdisciplinary science that derives from biology, mathematics, computer science, physics, engineering, and other disciplines. The infusion and integration of theories and techniques from other fields are establishing new methodologies for problem definition, hypothesis generation and testing, and experimental approaches in biomedical science. Most biological systems are too complex for even the most powerful computational models to capture all system properties. A useful model, however, should conceptualize and formalize the system under study such that it becomes a powerful hypothesis generator. There is a need for ongoing research on such issues as capturing network structure, parameter estimation and optimization, and model scalability, with the goal of learning how models can be usefully employed to understand and predict biological behavior. An attractive way to achieve this goal is to develop collaborations between biologists and experts from other fields. Such interdisciplinary collaborations will likely provide the inspiration for the generation of new conceptual thinking, as well as new systems biologists.

Technological Challenges. Currently, technological deficits exist in mathematics, computation and experimentation. There are continuing challenges in applying mathematics to the complexity of living systems. Growing volumes of data from diverse high-throughput experiments provide unprecedented opportunities for computational biologists, but also challenges in data storage, analysis, archiving and visualization. Experimentally, there is a demand for high-throughput and other technologies that will help populate quantitative models. Further improvements in measurements at all scales are needed. It is particularly important to sample living systems dynamically, at multiple scales, if realistic models are to be constructed. The systems biology centers are encouraged to develop innovative approaches to address these and other technological challenges.

Training, Outreach and Organizational Challenges. Building cohesive multi-disciplinary research teams by integrating expertise across traditional disciplinary boundaries is not a simple undertaking. A goal of this initiative is to encourage leadership in creating such teams. There is a continuing need to disseminate knowledge widely through outreach activities to the research community through appropriate conferences, personnel exchanges, and sharing of resources. Importantly, the emergence of a new science demands an adequate, diverse workforce of appropriately trained scientists. The future leaders of systems biology research will be knowledgeable and skilled in both experiment and computation. Innovation in research training therefore, is a significant task of the Systems Biology Centers.

The NIGMS strongly supports the analysis of complex biological systems through investigator-initiated research project grants, using the R01, P01, and other appropriate grant mechanisms. However, the resources needed to conduct multi-faceted, multi-disciplinary projects with significant new training and outreach activities is beyond the scope of the typical R01 or P01 grant. Therefore, this FOA provides an opportunity for applicants to assemble unique teams of researchers from diverse disciplines that may not be possible with other funding mechanisms.

Scope of Research

NIGMS intends to promote development of systems biology in areas that are central to the Institute’s mission. Examples of NIGMS mission areas that are relevant to systems biology include, but are not limited to, the following:

Recruitment and Retention

The NIH recognizes a unique and compelling need to promote diversity in the biomedical, behavioral, clinical and social sciences workforce. The NIH expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups; to improve the quality of the training environment; to balance and broaden the perspective in setting research priorities; to improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and to improve the Nation’s capacity to address and eliminate health disparities.

Accordingly the NIH continues to encourage institutions to enhance the pool of students and faculty from backgrounds nationally underrepresented in the biomedical, clinical, behavioral, and social sciences such as: individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research.

The scope and nature of systems biology studies provide an excellent opportunity to enhance diversity of the biomedical research workforce.  Recruitment at all career levels is appropriate, and applicants are encouraged to establish programs that give priority to the undergraduate through professional career levels. These activities must be integrated in the ongoing research activities of the Center.

Special Requirements

Only one renewal will be allowed for each award, making the total length of support for any P50 center under this program limited to a maximum of ten years. During the third year of the first grant cycle, the center will receive an administrative site visit to evaluate the center’s progress on research, research training, outreach, and diversity recruitment efforts. The fifth year of funding will depend on the outcome of that administrative review, and the PD/PI will receive advice about NIGMS interest in accepting a renewal application to extend the initial award.

Additional Information

Currently, the NIGMS supports more than twelve P50 National Centers for Systems Biology (http://www.nigms.nih.gov/Initiatives/SysBio/). Potential applicants are encouraged to view the websites of funded centers http://www.systemscenters.org, to discuss their ideas with NIGMS program staff, and to send a letter of intent prior to submission to ensure that the application will be responsive to the mission of NIGMS and the intent of this FOA.

Section II. Award Information
Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New
Renewal
Resubmission

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

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.

NIGMS intends to fund an estimate of two to four awards, corresponding to a total of $10 million, for fiscal year 2014. Future year amounts will depend on annual appropriations.

Award Budget

An applicant may request a budget in direct costs up to $2 million per year.  Application budgets need to reflect actual needs of the proposed project.  Funds for initial large equipment may be requested in excess of the $2 million limit if prior approval is obtained from staff responsible for Scientific/Research issues, listed in Section VII.

Award Project Period

An applicant may request a project period of up to five years.  The fifth year support for new awardees is conditional on a successful administrative site visit in the third year of the award.  Awardees may apply for single renewal, so the maximum time period is ten years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information


1. Eligible Applicants


Eligible Organizations

Higher Education Institutions

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) 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. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. 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. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH 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.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility


Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

Awards are made with an initial project period up to 5 years and only one renewal is allowed for each award, making the total length of support for any P50 center under this program limited to a maximum of ten years.  The Program Directors/Principal Investigators who went through this program once in a role of a Program Director/Principal Investigator are allowed to submit a new application for a new center. However, such new applications must be substantially different from previous centers run by the applicants in content and scope, including different research problems, approaches, personnel, training and outreach target groups and strategies, with more significant differences than are normally encountered in a renewal application. Applicants may consult the NIH policy for this matter at http://public.csr.nih.gov/ApplicantResources/ReceiptReferal/Pages/Evaluation-of-Unallowable-Resubmission-and-Overlapping-Applications.aspx. Applications seeking renewal of grants beyond the ten-year limit that have the same content and scope but different Program Directors/Principal Investigators will be deemed ineligible and will not proceed to peer review (as described in NOT-GM-13-120).

Section IV. Application and Submission Information


1. Requesting an Application Package

Applicants can access the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement 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.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

Letter of Intent

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:

The letter of intent should be sent to:

Peter M. Lyster, Ph.D.
Telephone: 301-451-6446
Fax: 301-480-0884
Email: lysterp@mail.nih.gov

Page Limitations

Component Types Available in ASSIST

Research Strategy/Program Plan Page Limits

Overall

6

Admin Core

6

Core (use for Research Cores)

6

Project (use for Systems Biology Research Projects)

12

Required Activities

6


Additional page limits described in the SF424 Application Guide and the Table of Page Limits must be followed.

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

Overall Component

When preparing your application in ASSIST, 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)

Complete entire form.

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.

Other Attachments: The following information should be loaded as separate PDF attachments. The filename provided for each attachment will be the name used for the bookmark in the application image.

Center Organizational Structure. Applicants should include a diagram of the organizational structure of the Center. This diagram should demonstrate how the interactions among the Center components will achieve the stated goals of the Center.  The diagram should be attached as a PDF titled "Center_Organizational_Structure".

Table of Research Core Utilization (if applicable). In order to assist the reviewers in determining the relationship between the Research Cores and the Research Projects, a table should be provided that indicates the percentage use of each core relative to the individual projects. The table should be attached as a PDF titled "Table_of_Research_Core_Utilization".

Institutional commitment.  A strong institutional commitment is encouraged, and should be described if provided.  The commitment may include faculty appointments, partial salary support for investigators, purchase of research equipment, and assignment of research space to support the research and facilitate collaboration and interdisciplinary interaction.

Project/Performance Site Location(s) (Overall)

Enter primary site only.

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 & Related Senior/Key Person Profile (Overall)

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

An individual can serve as Center Director of a NIGMS P50 Center of Excellence grant while serving as the PD/PI of another NIGMS supported research Center. 

Multiple Center Directors are allowed; however, very strong justification for the need of such arrangement is expected to be provided in the Multiple PD/PI Leadership Plan on the Research Plan form below.

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.

Budget (Overall)

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:  Specific Aims should be the overall vision for the Center.  These Specific Aims should not be the same as the specific aims of the other components, but should be overarching and at a high level.

Research Strategy:   The Overall Component should provide a concise vision and proposed plan for the Center.  What biological problems are being addressed with the systems approach, how computational modeling will be utilized, what other approaches, methods, software, and tools will be generated, and how will the Center be useful?  Applications should demonstrate that use of the Research Center mechanism is essential to accomplishing studies that would not occur without the climate, facilities and research resources that a Research Center can uniquely provide.

The Overall Component should also include a concise description of the structure of the Center, including a brief management plan. The plan, along with the Center Organizational Structure diagram (provided in "Other Attachment) should explain how the components of the organization, including key personnel, will interact, why each is essential for accomplishing the overall Center goals, and how the organization of the components into a Center will create an entity that is greater than the sum of its parts in terms of generating results that will be important for the greater biomedical research community.

Center Integration.  The program does not have explicit requirements for types of integration.  Applications should explicitly discuss the integration of work proposed in the application.  While the scientific research is focused on at most four structural units (Systems Biology Component projects), applicants are encouraged to describe cross-cutting elements in this Overall Component. Applications should demonstrate that use of the research Center mechanism is essential to accomplishing studies that would not occur without the climate, facilities and research resources that a research Center can uniquely provide.  Some investigators may wish to describe integrative or cross cutting features of the application which do not fall neatly in to the specific Systems Biology Research Components.

Infrastructure. Each Center application is expected to provide evidence of an environment that promotes the conduct of the highest quality, state-of-the-art research, innovation, and leadership in the area of systems biology. Systems research requires sophisticated experimental equipment as well as appropriate computer, data storage, and networking infrastructure resources.  Briefly summarize the infrastructure resources that are available, to be obtained, or will be developed during the award, and justify how these resources will be used to support the research at the host institution as well as the biomedical research community. 

Center Director. The Center Director should be an outstanding, productive, senior researcher, as documented by publications, patents, honors, and similar indices of stature. The Center Director is responsible for overall coordination and development of the Center with the responsibility to provide leadership essential to the success of the Center program, to ensure interaction and collaboration among scientists conducting research, to monitor ongoing research and identify (with the assistance of colleagues) research, training and outreach activities to be expanded or decreased and needs for additional resources or reallocation of resources.

Key Personnel. A cadre of experienced, independent and productive investigators should be present in the proposed Center. These investigators should evidence productivity, stature and leadership, or a potentially strong leadership role, in their respective fields. A broad range of expertise relevant to the Center's goals should be present. Investigative efforts may encompass researchers with primary appointments at the applicant institution as well as at other collaborating sites. Investigators are expected to commit to data sharing and ongoing communications with other investigators in the Center.

Progress Assessment and Evaluation.  The National Centers for Systems Biology program supports a combination of pathfinding basic research and research training.  No simple set of metrics are expected to capture the knowledge that will be useful for assessment and evaluation of the Center.  Investigators are asked to provide a short description of what narrative and data information will be gathered.  This may include: impact on science; quality of papers; success of students, post docs, and professional scientists; outreach and dissemination of products and software; impact on the institution.

For Renewal Applications Only. Include a progress report including a summary of the most significant advances accomplished during the prior period of support. The Progress Report should demonstrate the research environment's conduciveness to productivity by identifying the originally approved specific aims and the progress made on each specific aim. It is especially important that renewals (1) identify innovative work accomplished by the Center during the current funding period and (2) propose innovative work for the new funding period. Changes in the Specific Aims, including termination of Research Components or Cores, should be described and justified and major findings presented with clear descriptions of the importance of these findings to advances in the field. The application should also address any significant organizational changes, and provide summaries of training activities as well as results of outreach and dissemination activities.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

Plan for Software Sharing:  A software dissemination plan, with appropriate timelines, is expected to be included in the research sharing section of the application. There is no prescribed single license for software produced through grants responding to this announcement.  However, NIH does have goals for software dissemination, and reviewers will be instructed to address and evaluate the dissemination plan relative to these goals:

1. The software should be freely available to biomedical researchers and educators in the non-profit sector, such as institutions of education, research institutions, and government laboratories. 

2. The terms of software availability should permit the commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages.

3. To preserve utility to the community, the software should be transferable such that another individual or team can continue development in the event that the original investigators are unwilling or unable to do so.

4. The terms of software availability should include the ability of researchers outside the Center to modify the source code and to share modifications with other colleagues as well as with the Center.  An applicant should take responsibility for creating the original and subsequent “official” versions of a piece of software.

5. Applicants are asked to propose a plan to manage and disseminate the improvements or customizations of their tools and resources by others.  This application may include a plan to incorporate the enhancements into the “official” core software, may involve the creation of an infrastructure for plug-ins, or may describe some other solution.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Administrative Core

When preparing your application in ASSIST, use Component Type ‘Admin Core.’

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

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.

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)

Budget (Administrative Core)

Budget forms appropriate for the specific component will be included in the application package.  Costs and justifications for activities of the External Scientific Advisory Board should be included in the application.

At its discretion, NIGMS may consider the award of supplemental funds to defray the allowable costs incurred in hosting the meeting; however, all requests for supplemental funds must include verification that funds are not otherwise available to cover these costs and could not be made available by rebudgeting from other cost categories.

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 and Revision applications, an Introduction to Application is allowed for each component

Specific Aims:  This section should include Specific Aims of the Administrative core.

Research Strategy:  The Administrative Core is expected to have appropriate and effective administrative and organizational capabilities to support multidisciplinary systems biology research, training and outreach, to foster synergy, and to support planning and evaluation activities. The Program Director/Principal Investigator (PD/PI) of a center grant must commit a minimum effort of 30% or 3.6 person-months per year to the project.

The Administrative Core is expected to have a scientifically and administratively qualified Center Director with responsibility for the scientific, administrative, budgetary, and operational aspects of the Center.

Management Plan.  The application should describe the management and integration of activities in the Center. Applicants should specify appropriate administrative/business management staff, as well as the oversight mechanisms that will be used by the Center Director (PD/PI), any Center Co-Directors, and any other relevant key personnel. The management plan should include how decisions will be made to add new projects and terminate projects that have acquired other sources of support or have not made adequate progress. The plan should describe any provisions for the mentoring and development of new investigators. If multiple geographic sites are involved in the proposed Center, the Administrative Plan should describe the leadership and communication plans to manage the multiple sites.

External Scientific Advisory Board.  The center will be expected to have a scientific advisory board, drawn from experts outside of the project. These advisors will meet annually to review and provide guidance on center activities. While a description of the board's activities should be included in the application, potential members of the board should not be contacted, named, or selected until an award has been made (applications for renewals may name only existing members). This stipulation will allow a wider pool of potential reviewers of the application. Renewal applications should list individuals who have served or currently serve in this capacity.

Program Annual Meeting. Funded centers are expected to attend annual meetings of the NIGMS National Centers for Systems Biology Program, in order to present results and to communicate with other centers. For the purpose of preparing an appropriate budget, it should be presumed that at least two representatives of each center (including the PD/PI) will attend this annual meeting. Participating faculty, graduate students, postdoctoral associates, center staff, and scientific advisory board members all are encouraged to attend the scientific sessions of the annual meeting. Each meeting will be hosted by one of the centers, in turn, and it will be the responsibility of the hosting center to plan the program (with approval from NIH staff) and to advise attendees regarding local arrangements.

Center Website. The application should describe the plans to establish and maintain a Center website to communicate the Center’s mission, describe the availability of resources and other products of the Center, and disseminate research data, software, training information and other resources of the project. Funded Centers are also expected to contribute to a working group that manages the joint NIGMS National Centers for Systems Biology web site http://www.systemscenters.org/.  To the extent that established public databases have the capability for collecting and disseminating the data that would be collected under the grant, it is NIGMS' strong preference that a plan for the rapid deposition of data into such public databases also be described in the application.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report (Administrative Core)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. 

PHS 398 Cumulative Inclusion Enrollment Report (Administrative Core)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide. 

Research Core

When preparing your application in ASSIST, use Component Type ‘Core.’

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Research Core)

Complete only the following fields:

PHS 398 Cover Page Supplement (Research Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research 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.

Project /Performance Site Location(s) (Research 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 (Research Core)

Budget (Research Core)

Budget forms appropriate for the specific component will be included in the application package.

In developing the budget, applicants should take into account funds currently available through existing collaborating grants and explain how these funds might be reconfigured to maximize efficient resource utilization. The Center is intended to provide reasonable support for activities clearly related to the specialized research needs of the Center.

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          (Research Core)

Introduction to Application: For Resubmission applications, an Introduction to Application is

allowed for each component

Specific Aims:  This section should include Specific Aims of the Research Core.

Research Strategy:  A Research Core can be a laboratory, a facility, a service, or other shared resource that supports other Center components in their activities.  Research Cores are expected to support two or more Research Projects and each Research Core should be clearly described in terms of the services and resources to be provided to other Center components.  Issues to be addressed include: quality control, procedures for selecting projects that use the Core, cost effectiveness, and increased efficiency.  Training in complex techniques and methods should be described if they are functions of the proposed cores. Core components are intended to enhance opportunities for investigators at the Center to include new technologies that broaden their research initiatives. While research per se is not an essential part of a scientific core, quality assurance activities that evaluate its operations and are directed at problem identification and improvement of core functioning are appropriate.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Systems Biology Research Project

When preparing your application in ASSIST, use Component Type ‘Project’.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Systems Biology Research Project)

Complete only the following fields:

PHS 398 Cover Page Supplement  (Systems Biology Research Project)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Systems Biology Research Project)

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.

Project/Performance Site Location(s) (Systems Biology Research Project)

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 (Systems Biology Research Project)

Budget (Systems Biology Research Project)

Budget forms appropriate for the specific component will be included in the application package.

Systems Biology research is the major activity of a Center and should be the major part of the budget.   

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          (Systems Biology Research Project)

Introduction to Application: For Resubmission applications, an Introduction to Application is required in the Overall component.

Specific Aims:  This section should include the Specific Aims of the Systems Biology Research Component.

Research Strategy:  The Center should consist of several distinct research projects (at most 4) integrated at a higher level in the general theme of the Center.  Projects should focus on innovative and high-impact systems biology approaches in the context of biomedical research.  The applicant should identify the research questions s/he proposes to address, and how these questions are related to important biomedical, translational, or clinical research problems.

Each Research Project that uses Center Core facilities should describe how the Core resources impact the proposed project.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Additional Required Center Activities 

When preparing your application in ASSIST, use Component Type ‘Required Activities’.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Additional Required Center Activities)

Complete only the following fields:

PHS 398 Cover Page Supplement  (Additional Required Center Activities)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Additional Required Center Activities)

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.

Project/Performance Site Location(s) (Additional Required Center Activities)

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 (Additional Required Center Activities)

Budget (Additional Required Center Activities)

Budget forms appropriate for the specific component will be included in the application package.

Undergraduate or graduate student support in the form of a stipend is not allowed; however, salary/wages is allowable.

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          (Additional Required Center Activities)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is required in the Overall component.

Specific Aims:  This section should include the Specific Aims of the Additional Required Center Activities component.

Research Strategy:  In addition to the leadership in systems biology research, Centers are expected to have significant innovative components of research training and outreach which take advantage of Centers unique environments. To maximize the impact, Centers should engage in training activities and curriculum development appropriate to their institutions that will address the needs of students and professional level scientists.  Training may be tailored to 1) quantitative scientists (including mathematicians, computational and engineering scientists) who wish to apply their skills and knowledge in the biomedical sciences, or 2) biomedical scientists who wish to gain the requisite knowledge and skills in quantitative and computational biology.

At the student level, applicants are expected to identify current educational gaps and needs and to propose creative responses. At the professional level, Centers should propose plans to support and nurture junior and new investigators. Incorporation of developmental research projects led by new investigators in the Center management plan is strongly encouraged.

Systems Biology Centers are expected to promote training through the broad, effective dissemination of the approaches, methods, software, tools, and related resources they develop.  Any of a variety of approaches to the training of the user communities may be proposed.  Examples of acceptable training activities include short courses offered at the Center, workshops and demonstrations at scientific meetings, on-line tutorials, development and sharing of Systems Biology research use cases, and standard or innovative uses of the Center’s web site.  The application should explain the plans for dissemination of the approaches, methods, software, tools, related resources, and associated documentation.

Centers should design their outreach program with the goal of serving scientific communities beyond the participating investigators and institutions. This can be achieved through research collaborations, facility support, visiting investigatorships, fellowships, workshops, summer courses, internships, symposia, Center websites, and/or other means. Outreach to groups of individuals underrepresented in biomedical research is required (see Recruitment and Retention below). Over a period of time, Centers should evolve into highly integrated research, research training, and knowledge-exchange headquarters that will make substantial contributions in the field of systems biology.

Successful Centers should provide their home institutions with the means to implement organizational and professional changes that will make systems biology research an attractive career option for both established and entry-level investigators. A variety of organizational models is possible, and it is not the intent of this announcement to prescribe any particular one.

Applicants must describe their specific plans for and recent experience with the recruitment and selection process.  Renewal and non-competing applications must include a detailed account of experiences in recruiting individuals from underrepresented groups during the previous funding period. This FOA requires all applicants to submit a recruitment and retention plan to enhance diversity, the evaluation of this will not be factored in to the determination of scientific merit and impact score of the application, but will be considered by Program in making funding recommendation. For general information on recruitment and retention plans please see the FAQ http://grants.nih.gov/training/faq_diversity.htm.  Other NIH funding opportunities exist that can be utilized by funded projects to obtain supplemental support to promote diversity in biomedical research. Those are described in a separate announcement (http://grants.nih.gov/grants/guide/pa-files/PA-12-149.html).

The Center must appoint an outreach coordinator who will be responsible for, among other outreach tasks, leading the recruitment effort, overseeing selection and placement of trainees, assessing academic and research progress of students, etc.  Development of partnerships with minority and minority-serving institutions and organizations is also encouraged.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

Post-Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

Section V. Application Review Information


1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

The impact score of the Overall Component is the impact score of the entire application.  

Reviewers will also provide a written critique and overall impact score (but not individual criterion scores) for each Systems Biology Research Project using the standard NIH criterion.

Overall Impact - Overall

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Center to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the Center proposed).

Scored Review Criteria - Overall

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a Center that by its nature is not innovative may be essential to advance a field.

Significance

Does the Center address an important problem or a critical barrier to progress in the field? If the aims of the Center are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the Center? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Are the levels of effort proposed for the PI/PD and other key personnel adequate?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Center? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? 

If the Center involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

If research cores are proposed, are they of high quality with appropriate personnel, and do they provide essential service(s) to the Center?  Does the application 

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Additional Review Criteria - Overall

As applicable for the Center proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Center Leadership

Does the application provide convincing evidence that the center, if funded, will become a leader in research, technology development, research training, knowledge exchange, and community development?

Management Plan

Is the management plan adequate and sufficiently flexible to allow addition of new projects and termination of projects that have successively acquired other sources of support or have underperformed?  Is there a plan to foster development of new investigators? Is the plan for an advisory board to provide scientific and managerial oversight appropriate?

Additional Required Center Activities:

Are the center's plans for research training and outreach adequately described?

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children 

When the proposed Center involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

For Renewals, the committee will consider the progress made in the last funding period, the effectiveness of the PD/PI’s leadership, the impact of Center activities on the field, and the effectiveness of the center’s research training and outreach efforts.

Revisions

Not Applicable

Additional Review Considerations - Overall

As applicable for the Center proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS) 4) Software Sharing Plan.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NIGMS, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory General Medical Sciences Council. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information


1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.      

Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement. 

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

Scientific/Research Contact(s)

Peter M. Lyster, Ph.D.
Division of Biomedical Technology, Bioinformatics, and Computational Biology,
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-451-6446
Email: lysterp@mail.nih.gov

Paul Brazhnik, Ph.D.
Division of Biomedical Technology, Bioinformatics, and Computational Biology,
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-451-6446
Email: brazhnikp@mail.nih.gov

Peer Review Contact(s)

Helen R. Sunshine, Ph.D
Office of Scientific Review,
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-2881
Email: sunshinh@nigms.nih.gov

Financial/Grants Management Contact(s)

Lori Burge
Division of Extramural Activities
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-451-3781
Email: burgel@nigms.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.


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