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-10-200

Related Notices

  • September 11, 2013 - This PAR has been reissued as PAR-13-351.
  • August 22, 2013 - See Notice NOT-GM-13-127. Notice of Early Termination of this FOA.
  • May 22, 2013 - See Notice NOT-GM-13-120. Clarification of Rules for Program Directors/Principal Investigators on Sunsetting National Centers for Systems Biology.
  • October 15, 2012 - See Notice NOT-GM-12-116. The purpose of this Notice is to clarify where the Plan for Software Sharing should be placed for applications.

Funding Opportunity Announcement (FOA) Number

PAR-12-187

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, education, 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, www.nigms.nih.gov

 
Key Dates
Posted Date

May 16, 2012

Letter of Intent Due Date

September 23, 2012; September 23, 2013; September 23, 2014

Application Due Date(s)

October 23, 2012; October 23, 2013; October 23, 2014

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

March-April 2013; March-April 2014; March-April 2015

Advisory Council Review

May 2013; May 2014; May 2015

Earliest Start Date(s)

July 1, 2013; July 1, 2014; July 1, 2015

Expiration Date

(Now Expired August 22, 2013 per NOT-GM-13-127), Originally October 24, 2014

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. While some links are provided, 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.

Looking ahead: NIH is committed to transitioning all grant programs to electronic submission using the SF424 Research and Related (R&R) format and is currently investigating solutions that will accommodate NIH’s multi-project programs. NIH will announce plans to transition the remaining programs in the NIH Guide to Grants and Contracts and on NIH’s Applying Electronically website.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of 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 mechanism (P50) is intended to facilitate pioneering research, research training, education, and outreach programs in this emerging 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, Education, 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 and education, 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:

Training, Education, and Outreach

In addition to the above-described leadership in systems biology research, centers are expected to have significant innovative components of research training, education, and outreach.  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.  At the student level, applicants are expected to identify current educational gaps and needs and to propose creative responses.  Applicants should note that undergraduate or graduate student support in the form of a stipend is not allowed; however, salary/wages is allowable.  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. 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, education 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.

Management and Organization

A management plan for the Center must be provided.  It 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.  Additionally, the plan should address/acknowledge the following:

Project Director/Principal Investigator Effort
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. 

Scientific Advisory Board
The center will be expected to have a scientific advisory board, drawn from experts outside 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 competing renewals may name only existing members).  This stipulation will allow a wider pool of potential reviewers of the application.  Costs and justifications for activities of the board should be included in the application. Renewal applications should list individuals who have served or currently serve in this capacity.

Program Annual Meeting
Funded centers are required 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.  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.

Center Website
Funded Centers are also expected to construct a center website for the dissemination of research data, software, and other resources of the project, and to contribute to a working group that manages the joint 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.

Recruitment and Retention

Recruitment and Retention Plan to Enhance Diversity
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 educational and 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 diversify their student and faculty populations and thus to increase the participation of individuals currently 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.  Institutions are encouraged to identify candidates who will increase diversity on a national or institutional basis.  The NIH is particularly interested in encouraging the recruitment and retention of the following classes of candidates:

A.   Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see data at http://www.nsf.gov/statistics/showpub.cfm?TopID=2&SubID=27 and the most recent report on Women, Minorities, and Persons with Disabilities in Science and Engineering). The following racial and ethnic groups have been shown to be underrepresented in biomedical research: African Americans, Hispanic Americans, American Indians, Alaska Natives, Native Hawaiians, and other Pacific Islanders. In addition, it is recognized that underrepresentation can vary from setting to setting; individuals from racial or ethnic groups that can be convincingly demonstrated to be underrepresented by the grantee institution should be encouraged to participate in this program.

B.   Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities.

C.   Individuals from disadvantaged backgrounds who are defined as:

1.    Individuals who come from a family with an annual income below established low-income thresholds. These thresholds are based on family size; published by the U.S. Bureau of the Census; adjusted annually for changes in the Consumer Price Index; and adjusted by the Secretary for use in all health professions programs. The Secretary periodically publishes these income levels at HHS - Poverty Guidelines, Research, and Measurement. For individuals from low income backgrounds, the institution must be able to demonstrate that such participants have qualified for Federal disadvantaged assistance or they have received any of the following student loans: Health Professions Student Loans (HPSL), Loans for Disadvantaged Student Program, or they have received scholarships from the U.S. Department of Health and Human Services under the Scholarship for Individuals with Exceptional Financial Need.

2.    Individuals who come from a social, cultural, or educational environment such as that found in certain rural or inner-city environments that have demonstrably and recently directly inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career. 

Recruitment and retention plans related to a disadvantaged background (C1 and C2) are most applicable to high school and perhaps undergraduate candidates, but would be more difficult to justify for individuals beyond that level of achievement.

The scope and nature of systems biology studies provide an excellent opportunity to enhance diversity of the biomedical research workforce.  Whereas recruitment at all career levels is appropriate, 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 and educational activities of the Center.  Applicants must describe their specific plans for and recent experience with the recruitment and selection process. Competing continuation and non-competing applications must include a detailed account of experiences in recruiting individuals from underrepresented groups during the previous funding period.  Furthermore, 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.  This FOA requires all applicants to submit a recruitment and retention plan to enhance diversity, the evalution of this will not be factored in to the determination of scientific merit and priority score of the appliction, 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. The plan must be submitted in a separate section with page limits defined below. 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-08-190.html).

Special Requirements

Renewal (Competing Continuation) and Administrative Site Visit
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, education, 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, 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

Application Types Allowed

New
Renewal
Resubmission

The OER Glossary and the PHS398 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 2013. 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 of new awardees is conditional on a successful administrative site visit in the third year.   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

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 must complete the following registrations as described in the PHS398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least4-6 weeks prior to the application due date.

Eligible Individuals (Program Director(s)/Principal Investigator(s))

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.

Multiple PD(s)/PI(s) are not allowed on this FOA. 

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 in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the PHS398 Application Guide.

Section IV. Application and Submission Information

1. Address to Request Application Package

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the PHS398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. 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.

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.
Division of Biomedical Technology, Bioinformatics, and Computational Biology
45 Center Drive
Building 45, 2AS-55K
Bethesda, MD 20892
Telephone: (301) 451-6446
Email: lysterp@mail.nih.gov

Application Submission

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional paper copies of the application and all copies of the Appendix files must be sent to:

Helen R. Sunshine, Ph.D.
Office of Scientific Review
National Institute of General Medical Sciences, NIH
45 Center Drive, Room 3An.12F, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-2881
FAX: (301) 480-8506
Email: sunshinh@nigms.nih.gov

Page Limitations

All page limitations described in the PHS398 Application Guide must be followed, and applicants are asked to use the following section headings and associated page limits:

Research Plan

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:

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 PHS398 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 proposal 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.

The review group will comment on the appropriateness and adequacy of the proposed Software Sharing Plan to meet the goals of the NIH in this program, but will not factor their comments into the determination of the overall score. Program staff and advisors will consider the adequacy of the proposed plan as one of the criteria for award. The proposed Software Sharing Plan, after negotiation with the applicant when necessary, will be made a condition of the award.  Evaluation of the annual non-competing progress reports will include assessment of the responsiveness to the Software Sharing Plan included in Notice of Award.

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide.

Foreign Institutions

Foreign (non-US) Institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the PHS398 Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 

Information on the process of receipt and determining if your application is considered “on-time” is described in detail in the PHS398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

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 received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

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-10-115.

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.

Overall Impact

Reviewers will provide an overall impact/priority 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

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(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?  Is the level 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?   

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

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/priority score, but will not give separate scores for these items.

Center Leadership and Impact: Does the application provide convincing evidence that the center, if funded, will become a leader in research, technology development, research training, education, 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 successfully 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? 

Research Training, Education, and Outreach: Are the center’s plans for research training, education, 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 Human Subjects Protection and Inclusion Guidelines.

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 Human Subjects Protection and Inclusion Guidelines.

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, education, and outreach efforts.

Revisions

Not Applicable.

Additional Review Considerations

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/priority 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).

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. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

Applications will be assigned to the appropriate NIH Institute or Center and 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(s)/PI(s) 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, CCR 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) 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

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

eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.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
Telephone: (301) 451-6446
Email: lysterpe@mail.nih.gov

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

Peer Review Contact(s)

Helen R. Sunshine, Ph.D.
Office of Scientific Review
National Institute of General Medical Sciences
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
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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