Part I Overview Information


Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), ( http://www.nih.gov/)

Components of Participating Organizations
National Institute of General Medical Sciences (NIGMS), (http://www.nigms.nih.gov/)

Title: NIGMS National Centers for Systems Biology (P50)

Announcement Type
This is a modification of RFA-GM-07-004, which was previously released July 7, 2006.

Update: The following update relating to this announcement has been issued:

Request For Applications (RFA) Number: RFA-GM-08-004

Catalog of Federal Domestic Assistance Number(s)
93.859

Key Dates
Release Date: June 11, 2007
Letters of Intent Receipt Date(s): September 21, 2007
Application Receipt Date(s): October 22, 2007  
Peer Review Date(s): March-April 2008
Council Review Date(s): May, 2008
Earliest Anticipated Start Date(s): July 1, 2008
Additional Information To Be Available Date (Url Activation Date): Not Applicable
Expiration Date: October 23, 2007

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
  1. Research Objectives

Section II. Award Information
  1. Mechanism(s) of Support
  2. Funds Available

Section III. Eligibility Information
  1. Eligible Applicants
    A. Eligible Institutions
    B. Eligible Individuals
  2. Cost Sharing or Matching
  3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
  1. Address to Request Application Information
  2. Content and Form of Application Submission
  3. Submission Dates and Times
    A. Receipt and Review and Anticipated Start Dates
      1. Letter of Intent
    B. Sending an Application to the NIH
    C. Application Processing
  4. Intergovernmental Review
  5. Funding Restrictions
  6. Other Submission Requirements

Section V. Application Review Information
  1. Criteria
  2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Sharing Research Data
    D. Sharing Research Resources
  3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
  1. Award Notices
  2. Administrative and National Policy Requirements
  3. Reporting

Section VII. Agency Contact(s)
  1. Scientific/Research Contact(s)
  2. Peer Review Contact(s)
  3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

Background

Medical, biotechnological, and other applications of biological knowledge increasingly depend on our ability to understand the principles that explain the behavior of the system as a whole.  Whether the goal is to comprehend basic physiology and disease processes, to identify specific targets for drug intervention, or to prevent the spread of emerging infectious diseases, the challenge is to achieve an understanding that leads to accurate prediction.  Predicting quantitatively how a complex system will respond to an intervention is intrinsically a computational problem.  For biological systems, this problem is daunting. 

Systems Biology describes a fundamental shift in both the conceptual and technical approaches that scientists use to discover the underlying principles of biological systems.  The field is developing as an integrated experimental, informational, and computational science that is driven by rapid advances in computational analysis of data from genomics, proteomics, and other high-throughput technologies.  As a result, there is a realistic hope that all the genetic elements, their expressed forms, and their variations amongst individuals and populations may be catalogued to produce a comprehensive “parts list.”  Coupled with extensive structural and mechanistic knowledge of individual molecules and pathways, this information allows biomedical researchers to turn their attention to understanding how biological components work together to produce complex phenotypes.  The adoption of a systems approach is providing new knowledge in many areas of biomedical research from cell dynamics and signaling networks to global metabolism and drug development.  It is expected that new, fundamental rules governing systems behavior at various organizational levels may emerge from these studies.  However, there are significant conceptual, technological, and cultural challenges to the realization of the systems biology goals.  It is the purpose of this initiative to promote innovative responses to these challenges. 

Conceptual Challenges.  Systems biology is a new interdisciplinary science that derives from biology, mathematics, computer science, physics, engineering, and other disciplines.   The infusion of theories and techniques from other fields and their integration to establish unique methodologies in problem definition, hypothesis generation, and project execution is a major challenge.  Most biological systems are too complex for even the most powerful computational models to capture all the system properties.  A useful model, however, should be able to accurately conceptualize the system under study and provide reliable predictive values.  To accomplish this, a certain level of abstraction may be required that focuses on the system properties of interest while neglecting some of the other details.  In this regard, there is a need for additional research on such issues as modulating systems, parameter optimization, and model scalability with the goal of learning how models can be usefully employed to understand and predict biological phenomena.   An attractive way to achieve this 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 both computation and experimentation.  These include lack of standards and quality control measures in data collection and software engineering.  High-throughput data collection is generating vast amounts of data that provides unprecedented opportunities for computational biologists.  However, a high level of heterogeneity in data quality and experimental conditions hampers data comparison, integration, and application in computational modeling.  Similar issues exist in software development.  The lack of software engineering standards and sufficient documentation has reduced software usability and resulted in unnecessary duplication of efforts.  Experimentally, there is a demand for the development of novel (and low cost) methodologies to miniaturize, standardize, and automate high-throughput data collection.  Dynamic measurement of live systems at multiple scales that allows digitalization and integration into realistic modeling process is another substantial challenge.  The Systems Biology Centers are encouraged to develop innovative approaches to address these challenges.

Cultural and Educational Challenges.  Building cohesive multidisciplinary research teams by integrating expertise across traditional disciplinary boundaries at the institutional level is not a simple undertaking.  A goal of this initiative is to encourage leadership in creating such teams.  In the larger research community, there is a need for leadership in the dissemination of new knowledge and to reduce excessive overlap and redundancy in project selection and tool development.  Centers will be expected to promote communication, collaboration, and technology and data sharing.  Another aspect to be nurtured is the dialog between theory and experiment.  The goal is to develop constant communication and feedback among experimentalists and theoreticians through the entire life cycle of a project.  Transforming data into systems knowledge and principles will require iterative cycles of data collection, model generation, and model validation.  Finally, the emergence of a new science demands an adequate workforce of appropriately trained scientists.  The future leaders of systems biology research will have to be knowledgeable and skilled in both experiment and computation.  Innovation in training, therefore, will also be 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 the multi-faceted, multi-disciplinary projects may be beyond the scope of the typical R01 or P01 grant.  Therefore, this RFA presents 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 further development of systems biology and broad application of systems biology approaches in areas that are central to the Institute’s mission of supporting basic biomedical and behavioral research. Recognizing systems biology as an emerging and evolving field with various definitions, for the purposes of this FOA, NIGMS defines systems biology as: a discipline at the intersection of biology, mathematics, engineering, and the physical sciences that integrates experimental and computational approaches to study and understand biological processes in cells, tissues, and organisms. Studies at the systems level are distinguished not only by their quantitative nature in data collection and mathematical modeling, but also by their focus on interactions among individual elements such as genes, proteins, and metabolites. These studies often integrate data from multiple levels of the biological information hierarchy in an environmental and evolutionary context and pay particular attention to dynamic processes that vary in time and space. Successive iterations of experiment and theory development are characteristic of systems biology. When applied to human health, systems biology models are intended to predict physiological behavior in response to natural and artificial perturbations and thereby contribute to the understanding and treatment of human diseases. Research areas that historically have been computationally based (e.g., molecular structure modeling) are excluded as a focus of this Center program. Research projects focusing on specific disease processes other than shock, trauma, and burn and research on specific organ systems that are the domain of other NIH Institutes and Centers are not eligible. NIGMS mission areas that are relevant to systems biology include, but are not limited to, studies on:

Leadership Development

The NIGMS National Centers for Systems Biology will be expected to provide national leadership in systems biology research, training, and knowledge dissemination.  They will accomplish this goal through the development of truly innovative programs that are expected to establish new research areas and new research culture, to develop and distribute enabling technologies, and to train a new generation of systems biologists.  Centers should design their programs 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.  Training and education is another significant task of the Centers.  To maximize the impact, Centers should conduct training at multiple levels from undergraduate education to professional career development that are appropriate to their institutions.  At the student level, applicants are expected to identify current educational gaps and needs, and 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 research and development plan is strongly encouraged.  Outreach to the groups of individuals underrepresented in biomedical research is required (see Special Requirements below).  Over a period of time, Centers should evolve into highly integrated research, training, and knowledge exchange headquarters that will make substantial contributions in the emerging 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 attractive career options 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.

Special Requirements

The NIH recognizes a 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 trainee 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 http://www.nsf.gov/statistics/).  Nationally, groups found to be underrepresented in biomedical and behavioral research include, but are not limited to, African Americans, Hispanic Americans, Native Americans (including Alaska Natives), and natives of the U.S. Pacific Islands.  In addition, it is recognized that under-representation can vary from setting to setting and 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 http://aspe.hhs.gov/poverty/indix.shtml. For individuals from low income backgrounds, the institution must be able to demonstrate that such candidates have qualified for Federal disadvantaged assistance or they have received any of the following student loans: Health Professional 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 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.  Furthermore, the Center must establish an outreach coordinator position 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.  Information on relevant minority-serving institutions may be obtained by consultation with staff of the NIGMS Division of Minority Opportunities in Research (http://www.nigms.nih.gov/Minority/).  This RFA requires all applicants to submit a recruitment and retention plan to enhance diversity which will be evaluated by reviewers in the determination of scientific merit and priority score of the application. 

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-05-015.html).

Only one renewal will be allowed for each award, making the total length of support for any P50 Center under this program to be 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, education, outreach, and diversity recruitment efforts. The fifth year of funding will depend on the outcome of that administrative review, and the PI will receive advice about NIGMS interest in accepting a renewal application to extend the initial award.

The Project Director/Principal Investigator of a Center grant must commit a minimum effort of 30% or 3.6 months per year to the project.  Center Directors may be asked to join a committee to promote inter-Center collaborations and/or to organize annual meetings of the National Centers for Systems Biology Program. 

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.  This stipulation will allow a wider pool of potential reviewers of the application.  Costs for activities of the Board should be included in the budget.

Applicants should have a plan to construct a Center website for the dissemination of research data, software, and other resources of the project.  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 is described in the application.

Software developed by the Center is expected to be freely available to biomedical researchers and educators in the non-profit sector, such as institutions of education, research institutes, and government laboratories.  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. The terms of software availability should include the ability of researchers outside the Center and its collaborating projects to modify the source code and to share modifications with other colleagues as well as with the Center.  The application must include written statements from the officials of the applicant institutions responsible for intellectual property issues, to the effect that the institution supports and agrees to abide by the software dissemination plans put forth in the application.  Typically the relevant responsible official will be in the applicant institution’s office of technology transfer or intellectual property, as opposed to an academic official such as a department head or dean. 

Since the inception of the National Centers for Systems Biology Program in 2001, the NIGMS has established seven P50 Centers (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 and intent of this RFA.  Research conducted by future new Centers should complement the projects already funded.

Unfunded applications submitted in response to the previous releases of this RFA may be submitted as resubmission (amended) applications.  Resubmission (amended) applications must include an Introduction describing the changes and improvements made.  The page limit for the Introduction is five pages.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information


1. Mechanism(s) of Support

This funding opportunity will use the P50 Specialized Center award mechanism.

As an applicant, you will have primary responsibility for planning, directing, and executing the proposed project.

This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.

2. Funds Available

The NIGMS intends to commit up to $10 million dollars in total cost in FY 2008 to fund up to three new and/or competing continuation (renewal) grants in response to this RFA. An applicant may request a project period of up to five years and a budget for direct costs up to $2 million per year. 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.1. The fifth year support of new awardees is conditional on a successful administrative site visit in the third year. The earliest anticipated start date is July 1, 2008. 

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award may also vary. Although the financial plans of the IC provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

You may submit applications if your organization has any of the following characteristics:

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution 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.

2. Cost Sharing or Matching

Cost sharing or matching is not required.

The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing

3. Other-Special Eligibility Criteria

None

Section IV. Application and Submission Information


1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.

3. Submission Dates and Times

Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date(s): September 21, 2007
Application Receipt Date(s): October 22, 2007
Peer Review Date(s): March-April 2008
Council Review Date(s): May, 2008
Earliest Anticipated Start Date(s): July 1, 2008

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

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.

The letter of intent is to be sent by the date listed at the beginning of this document.

The letter of intent should be sent to:

Jiayin (Jerry) Li, M.D., Ph.D.
Center for Bioinformatics and Computational Biology
National Institute of General Medical Sciences, NIH
45 Center Drive, Room 2As.55C, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 451-6446
FAX: (301) 480-2802
Email: lij@nigms.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant applications found in the PHS 398 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)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

At the time of submission, two additional copies of the application and all copies of the appendix material 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

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf.

3.C. Application Processing

Applications must be received on or before the application receipt date described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the NIGMS. Incomplete and non-responsive applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application or in response to a different announcement, is to be submitted in response to this funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

The exception is previous applicants to RFA GM-07-004 who may submit resubmission applications in response to this announcement.  Resubmission applications must include an Introduction (5 pages) describing the changes and improvements made, and the text must be marked to indicate the changes from the previous unfunded version of the application. All instructions in this announcement must be followed.

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

4. Intergovernmental Review

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. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or renewal award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or renewal award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.

6. Other Submission Requirements

Application Instructions

Applicants should follow the general instructions for PHS 398 application form with the exception of specific instructions relevant to this RFA given below.

Description (Page 2 of the Application Form): 

In the Description, applicants should describe concisely the mission of the proposed research center, the organizational structure, the goals of the research projects, and the plans for training and outreach activities.

Table of Contents

Prepare a detailed Table of Contents that includes all elements of the application.  Use numeric pagination only.

Participant Affiliations: 

Application should include a separate sheet after the biosketches that lists 1) all participants, including consultants and private sector alliances; 2) all the institutional affiliations for each participant; 3) their roles on the project; and 4) the effort listed separately for each role. 

Page Limit: 

The page limit for the Research Plan section of the application is 80 pages.  Please note that there is no requirement to submit the maximum number of pages; instead, concise, articulate applications are desired.  Applicants may submit CDs or DVDs as appendix material to illustrate some of the dynamic imaging or computational programs that do not convey well on paper.   

Research Plan: 

Rather than divided into several sections each describing an autonomous subproject, the Center proposal should be presented as a whole and include the following components in this order: 

A timeline for the project should be presented.  This timeline should outline how the project's goals can be met within the time frame of the grant. The timeline also will assist the investigators, the NIGMS, and its advisors in evaluating progress toward the project's goals. 

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

All applicants must include a plan for sharing research data in their application. The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing. All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.

The reasonableness of the data sharing plan will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Sharing Research Resources

NIH policy expects that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.

Section V. Application Review Information


1. Criteria

Only the review criteria described below will be considered in the review process.

The following will be considered in making funding decisions:

2. Review and Selection Process

Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIGMS in accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance: Does this proposal address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the Project Director/principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

2.A. Additional Review Criteria:

 In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

Resubmission Applications (formerly “revised/amended” applications): Are the responses to comments from the previous scientific review group adequate? Are the improvements in the resubmission application appropriate?

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

2.C. Sharing Research Data

Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The presence of a data sharing plan will be part of the terms and conditions of the award. The NIGMS will be responsible for monitoring the data sharing policy.

2.D. Sharing Research Resources

NIH policy expects that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

Program staff will be responsible for the administrative review of the plan for sharing research resources.

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Reporting.

3. Anticipated Announcement and Award Dates

The earliest anticipated award date will be in July 2008.

Section VI. Award Administration Information


1. Award Notices

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.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the Notice of Award will be mailed to the business official.

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. See Also Section IV.5. Funding Restrictions.

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 (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement. The Annual Report is due two months prior to the grant anniversary date.  It should be sent to:

Division of Extramural Activities Support, OER
National Institutes of Health
6705 Rockledge Drive, Room 2207, MSC 7987
Bethesda, MD 20892-7987 (for regular or US Postal Service Express mail)
Bethesda, MD 20817 (for other courier/express mail delivery only)
Phone Number: (301) 594-6584

There is no specific page limit on the progress report.  It should include the following information: an overview of the major achievements made in the previous year including status on meeting the milestones, organizational and personnel changes, research progress, education and training activities, outreach activities, data and resource sharing, and intellectual property issues.

Section VII. Agency Contacts


We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Jiayin (Jerry) Li, M.D., Ph.D.
Center for Bioinformatics and Computational Biology
National Institute of General Medical Sciences
45 Center Drive, Room 2As.55C, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 451-6446
FAX: (301) 480-2802
Email: lij@nigms.nih.gov

2. Peer Review Contacts:

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

3. Financial or Grants Management Contacts:

Antoinette Holland
Division of Extramural Activities
National Institute of General Medical Sciences
45 Center Drive, Room 2An.50B, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-5132
FAX: (301) 480-2554
Email: hollanda@nigms.nih.gov

Section VIII. Other Information


Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review.

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_manual.htm).

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002 . The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles.  Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This RFA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. 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 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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