NIGMS National Centers for Systems Biology

RFA Number: RFA-GM-05-010

Part I Overview Information
Department of Health and Human Services

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

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

Announcement Type:
This is a reissue of RFA-GM-03-009 which was previously released on April 29, 2003

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

Catalog of Federal Domestic Assistance Number(s): 93.859

Key Dates
Release Date: September 22, 2004
Letters Of Intent Receipt Date: January 25, 2005
Application Receipt Dates(s): February 25, 2005
Peer Review Date(s): June–July, 2005
Council Review Date(s): September 22-23, 2005
Earliest Anticipated Start Date: December, 2005
Expiration Date: February 26, 2005


Executive Summary

This document invites applications for NIGMS National Centers for Systems Biology, a program established by a previous RFA titled “NIGMS Centers of Excellence in Complex Biomedical Systems Research” and published in the NIH Guide on January 26, 2001. The goal of the program is to promote institutional development of pioneering research, training, and outreach programs focused on quantitative, systems level analysis of biological phenomena of biomedical importance within the NIGMS mission. The NIGMS supports fundamental inquiries focused on molecular and cell biology, biophysics, genetics and developmental biology, human physiology in the areas of trauma, burn, inflammation, and multi-organ failure, and pharmacology and anesthesiology. The 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/icd/).

Under this program, the NIGMS will make one to three new awards using the P50 Center Grant mechanism. An application may request annual direct costs not to exceed $2 million, exclusive of subcontract indirect costs; single-year requests for exceptional equipment above this limit require prior approval of the program director. Organizations that are eligible for this program include domestic non-profit organizations; public or private institutions, such as universities, colleges, hospitals, and laboratories; units of state and local governments; and eligible agencies of the Federal government. Foreign institutions are not eligible to apply. There is no specific eligibility requirement for individuals to become Principle Investigators (PI), refer to eligibility information in Section III 1B. Applications must be prepared using the PHS 398 application form which can be downloaded at http://grants.nih.gov/grants/funding/phs398/phs398.html.

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

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 of Support
2. Funds Available

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

Section IV. Application and Submission and Instructions
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates
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
3. Merit Review Criteria
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources

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

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

Section VIII. Other Information - Required Federal Citations

Part II Full Text of Announcement
Section I. Funding Opportunity Description

1. Research Objectives

Background

The biomedical sciences have undergone a fundamental shift in both the conceptual and technical approaches that can be brought to bear on certain problems of profound importance. These problems center on the understanding of the behavior of biological systems whose function is the product of spatial and temporal ordering of myriad interacting components. Modeling approaches are being used to understand the orderly development of biological pattern in model organisms such as Drosophila and Caenorhabditis elegans, and at the clinical level, new approaches are being explored to understand the integrated activity of tissues and organs. Part of the impetus for systems-scale approaches rests on advances in acquiring data of the necessary quality and quantity to permit computational modeling. Among the most striking examples are the availability of complete DNA sequences for hundreds of organisms, including humans, and the availability of high-throughput instrumentation for analyses of gene function such as gene expression microarrays and proteomics technologies. These advances have made it feasible to generate a truly comprehensive parts list for any organism and to track changes over time. Ultimately, the enumeration of all the informational units of the genomes (protein coding genes, non-protein coding genes, regulatory regions), their processed forms, and their dynamic presence in the cells, should be possible.

Rapid technological advances in large-scale data collection and analysis have enabled scientists to have a global yet detailed view of cellular processes, instead of focusing on individual molecules or a small number of interacting molecules. As a result, unprecedented opportunities have emerged that may open the door to uncover hidden rules governing the ensemble of biomolecules working concertedly to perform certain functions in the cell. In the meantime, substantial challenges in information integration, interpretation, and representation have arisen. In order to move beyond the phase of cataloguing the parts list and truly transform data into knowledge and knowledge into principles, iterative cycles of data collection and model generation and validation will be necessary.

A higher order problem presents itself in understanding how the genome-encoded components and the other molecules (metabolites, ions, water etc.) are constituted in networks of interacting molecules with particular distributions in time and space. Advances in imaging techniques and analytic methods are beginning to yield copious quantitative and spatial data on specific molecules in biological systems. Knowledge of the network and changes in its components over time, and the local rules by which the individual components distribute material and information, will substantially advance our knowledge.

At the organism level, phenotype must take into account the relationships and interactions of biological and environmental variables. Basic biological systems, including gene sequences, structures, and pathways that direct metabolism and development, vary within individuals, among individuals, among populations, and among species. Advances in complex systems-level understanding must ultimately include models that account for these variations.

Medical, biotechnological, and other uses of biological information increasingly depend on our ability to understand the principles and dynamics that explain the behavior of the system as a whole. Whether the goal is to understand the consequences of disease or injury, or to identify particular molecular targets for drug interventions, or to modify the metabolism of microorganisms to produce medicines, the challenge is predictability. Predicting how the system of interest will respond to an intervention is a computational problem. For biological systems, this challenge is daunting.

Parallel to scientific challenges are organizational and educational challenges. At the institutional level, to build cohesive multidisciplinary research teams by integrating expertise across traditional disciplinary boundaries is not a simple undertaking. Beyond institutions, excessive overlap and redundancy in project selection and tool development exists in the research communities that could be reduced by promoting communications, collaborations, and technology and data sharing. The emergence of new science demands an adequate workforce of new scientists. Training for the future leaders of systems biology research who are knowledgeable and skilled in both experimental and computational subjects is timely. Good mechanisms and plans to address these challenges are significant tasks of the new Systems Biology Centers.

The NIGMS currently supports the analysis of complex biological systems through investigator-initiated research project grants, using the R01, P01, R21, and other appropriate grant mechanisms. However, the resources needed to conduct the multi-faceted, multi-disciplinary projects that may be required to achieve significant advances in these complex areas may be beyond the scope of the typical R01 or P01 grant. Therefore, this RFA presents an opportunity for applicants to assemble large teams of investigators from diverse disciplines that may not be possible with other funding mechanisms.

High priority will be given to projects that integrate multi-investigator, multi-disciplinary approaches with a high degree of interplay between computational and experimental approaches. Innovation is critical for both research project design and infrastructure design with a mission of serving communities beyond the participating investigators, institutions, and collaborators. A variety of organizational models is possible, and it is not the intent of this announcement to prescribe any particular one.

The NIGMS awarded two P50 Centers under this program in 2002 (http://www.nigms.nih.gov/news/releases/complex_centers.html), two Centers in 2003 (http://www.nigms.nih.gov/news/releases/complex_centers-2003.html), and one Center in 2004 (http://www.nigms.nih.gov/news/releases/quantitative_bio_center.html). Potential applicants should view the NIGMS website and the funded P50 Center websites to learn the research focuses of the existing Centers. Research conducted by the future Centers should complement and enhance the projects already funded.

Some groups interested in the subject of this RFA might find the P01 mechanism more suited to the scale of their efforts; they should consult the prior announcement at the URL: http://grants.nih.gov/grants/guide/pa-files/PA-98-077.html

Scope of Research

The NIGMS intends to support Systems Biology Research for the areas that 1) are central to its mission of supporting basic biomedical research, and 2) focus on developing new computational approaches to biomedical complexity. Research areas that historically have been computationally based (e.g., molecular structure and modeling) are excluded as a focus of this Center program. Research projects focusing on disease processes and their specific organ systems are not eligible. NIGMS mission areas include, but are not limited to, the following:

Center Developmental Activities

The NIGMS National Centers for Systems Biology will be expected to provide national leadership in systems biology research and training. To do so, they will be expected to support training and outreach activities that will insure the flow of information and expertise both into and out of the Centers. Centers should have plans to bring the most advanced technologies developed at other laboratories to the Centers and to disseminate expertise and knowledge to a wider community through collaborations, visiting investigatorships, fellowships, Center websites, workshops, symposia, summer courses/internships, and/or other means. To maximize the impact, Centers should conduct training at multiple levels appropriate to their institutions. Incorporation of developmental research projects led by junior and new investigators into the Center research and development plans is strongly encouraged. Over a period of time, Centers should evolve into integrated research, training, and knowledge exchange headquarters of scientific communities that will be the engines for coordinated scientific discoveries. The Centers should also have plans for outreach to undergraduate institutions, including minority-serving institutions. 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/about_nigms/more.html).

In addition to research and training contributions, successful Centers will 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.

Section II. Award Information


1. Mechanism of Support

This funding opportunity will use theNIH P50 Research Center Grant award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation and may be re-announced in the future. The earliest expected award date is in December, 2005. Applications submitted in response to the previous RFA announcements of this program, and unfunded, may be revised and resubmitted for this RFA.

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. Specifically, 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 $7 million in FY 2006 to fund one to three new P50 Center grants in response to this RFA. An applicant may request a project period of up to five years and a budget for direct costs of up to $2 million per year, exclusive of subproject fiscal and administrative costs (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-040.html). Funds for initial large equipment may be requested in excess of this $2 million limit if prior approval is obtained from staff responsible for scientific/research issues, listed in Section VII, prior to application submission. 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 will also vary. Although the financial plans of the NIGMS provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. In any event, the total length of support for any P50 Center under this program will be limited to a maximum of ten years. Successful Centers may want to seek support by other mechanisms upon termination of their programs.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

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

Although foreign institutions are not eligible to apply, foreign collaborators may participate in this program through sub-contract with domestic applications.

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 programs.

2. Cost Sharing

Cost sharing is not required under this program, as described in http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#matching_or_cost_sharing

3. Other-Special Eligibility Criteria

Applications focusing on specific disease processes and/or organ systems that are the primary missions of the other categorical institutes within the NIH (http://www.nih.gov/icd/) will be considered non-responsive to this RFA.

Section IV. Application Submission Instructions

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. 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 PHS 398 research grant application instructions and forms (rev. 5/2001). 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.

See also Subsection VI.2. Administrative and National Policy Requirements for additional information.

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

3.A. Receipt, Review and Anticipated Start Dates

Letters Of Intent Receipt Date: January 25, 2005
Application Receipt Dates(s): February 25, 2005

Peer Review Date(s): June-July, 2005

Council Review Date(s): September 22-23, 2005

Earliest Anticipated Start Date: December, 2005

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:

Dr. Jiayin (Jerry) Li
Center for Bioinformatics and Computational Biology
National Institute of General Medical Sciences, NIH
45 Center Drive, Room 2As.19F, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-0682
FAX: (301) 480-2004
Email: lij@nigms.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the PHS 398 research grant application instructions and forms as described above. 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 copies of the application and all copies of the appendix material must be sent to:

Dr. Helen R. Sunshine
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

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/label-bk.pdf.

3.C. Application Processing

Applications must be received on or before the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review.

The NIH will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, unfunded applications submitted in response to the previous versions of this RFA may be submitted as revised applications. Revised applications must adhere to the requirements specified in this document and include an Introduction describing the changes and improvements made. The page limit for the Introduction is five pages.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review

5. Funding Restrictions

All 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 (See also Section VI.3. Award Criteria).

6. Other Submission Requirements

Applicants should follow the general instructions for PHS 398 application form as stated above with the exception/addition 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 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 percent effort listed separately for each role.

Research Plan:

This section is the core of the application. Applicants should specify the administrative and organizational structure(s) that will be used to support the research, training, and outreach. It is anticipated that the Center projects will be multi-disciplinary and will draw on a variety of resources. Thus, a well thought out and carefully described organization will be required. The PI is responsible for ensuring that scientific goals are met, and for developing and managing a decision-making structure and process that will allow resources to be allocated (and reallocated, if necessary) to meet those goals. If core facilities or shared resources are required, these should be described, as should their management and service to the research projects. The applicant should explain how different components of the organization, including key personnel, will interact; why they are essential to accomplishing the research; and how the combined resources create capabilities that are more than the sum of the parts. If any of the components are physically separated from each other (i.e., located in different departments or institutions), the applicant should address how interactions will be facilitated. NIGMS is not specifying a specific organizational structure (e.g., specific numbers of projects and cores) in this RFA, preferring that applicants develop the structure that would best promote the research. However, applicants should note that the effectiveness of the proposed structure will be a criterion of the evaluation prior to an award and will be monitored after an award is made. Training and outreach goals are very important components of the application that will be critically evaluated by the review panel. Applicants should address the critical needs of a specific scientific area and describe plans to effectively meet those needs. As elaborated in the Research Objectives section of this document, the NIGMS expects the Centers to play a leading role in pioneering innovative research, establishing standards for data exchange, attracting the best technology and people to the Centers, disseminating information to a wider community, and providing the field with its future leaders. 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. For those projects for which the investigator deems it appropriate to do so, NIGMS encourages applicants to present explicit, quantitative milestones.

The total page limit for Research Plan is 80 pages that should include the following components:

Please note that there is no requirement to submit the maximum number of pages; instead, concise, articulate applications are desired.

Applicants can submit CDs as appendix material to illustrate some of the dynamic imaging or computational programs that do not convey well on paper.

Principal Investigator Effort:

The Principal Investigator of a Center Grant must commit a minimum effort of 30% to the project. Center Directors may be asked to join a committee to provide feedback on the success of this program and/or organize annual meetings of this program.

Center Advisory Board:

The Center will be expected to have a Board of Advisors, 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 named, contacted, 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 of Advisors should be included in the budget.

Center Website:

Applicants should have a plan to construct Center website for the dissemination of research data, resources, and other information 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's strong preference that a plan for the rapid deposition of data into such public databases also is described in the application.

Administrative Site Visit:

The Center will receive an administrative site visit during the third year of the first grant cycle. 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 competing renewal application to extend the initial award.

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.

Sharing Research Resources

NIH policy requires that grant award 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 and http://www.ott.nih.gov/policy/rt_guide_final.html . 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.

A software dissemination plan, if applicable, must be included in the application. There is no prescribed single license for software produced in this project. However, NIGMS does have goals for software dissemination, and reviewers will be instructed to make comments on 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 institutes, 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) 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.

The scientific review group will comment on the proposed plans for data, resources, and software sharing. The adequacy of the sharing plans will be considered by Program staff of the funding organization when making recommendations about awards. 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. Award Criteria.

Section V. Application Review Information

1. Criteria

No additional criteria are specified other than those cited below.

2. Review and Selection Process

Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIGMS. Incomplete applications will not be reviewed.

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

3. Merit Review Criteria

Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications.

The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of these criteria in assigning the application's overall score, weighting them as appropriate for each application.

Significance: Does the Center application address a significant problem in complex biomedical systems research? Does the proposal address the critical needs of the scientific community? If the goals proposed by the application are achieved, how will scientific knowledge be advanced, and how will the scientific community be better served? What will be the effect of these studies and training/outreach activities on driving the field forward?

Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? Does the application provide convincing evidence that the Center, if funded, will become a leader in research, training, knowledge exchange, and community development? 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 any special emphasis in the proposal to encourage active participation of junior and new investigators? Is the plan for an Advisory Board to provide scientific and managerial oversight appropriate? Are the center development and outreach plans adequately described? Do milestones articulate key indicators and a time frame that will demonstrate significant forward progress for the collaborative project? Will the research resources and data generated by the project be shared with the larger community and be easily accessible? Are there plans and institutional consent to adopt the open source code policy specified in Sharing Research Resources under Section IV 6 of this document?

Innovation: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? Are there innovative features in the organizational design, decision making, training, and outreach plans?

Investigator: Is the investigator appropriately trained, and well suited to carry out this collaborative project? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Is the level of effort proposed for the PI and the members of the steering committee adequate? Are the participating investigators well chosen for their roles in the collaborative project? Are the research grants of the participating investigators within the area of the collaborative project?

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there sufficient evidence of institutional support? Are the relationships between the proposed Center and other related Programs within the institution clearly laid out? Do they complement each other?

3.A. Additional Review Criteria:

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

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 also Section VIII - Other Information.

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 also Section VIII-Other Information.

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 398 research grant application instructions (rev. 5/2001) will be assessed.

3.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research.

3.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 funding organization will be responsible for monitoring the data sharing policy.

3.D. Sharing Research Resources

NIH policy requires that grant award 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 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. The reasonableness of the research resources sharing plan or the rationale for not sharing them 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 open source code requirement is specified in the Other Submission Requirements section of this document. Reviewers should evaluate the source code sharing plan in the proposal, and comment on the written statements on software dissemination from the officials of the applicant institution responsible for intellectual property issues. Reviewers will not factor the software sharing plan into the determination of scientific merit or the priority score.

The adequacy of the research data, resources, and software sharing plans 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 Principal Investigator before recommending funding of an application. The final version of the sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report. (PHS 2590). See Section VI.3. Award Criteria.

Section VI. Award Administration Information


1. Award Notices

After the peer review of the application is completed, the Principal Investigator will also receive a written critique called a Summary Statement.

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/archive/grants/policy/nihgps_2003/index.htm


A formal notification in the form of a Notice of award will be provided to the applicant organization. The notice of award signed by the grants management officer is the authorizing document.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NGA (Notice of Grant Award) are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

The NGA will be sent to the grants administrative official of the applicant organization by e-mail.

2. Administrative and National Policy Requirements

All NIH Grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the notice of grant award. 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/archive/grants/policy/nihgps_2003/index.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/archive/grants/policy/nihgps_2003/index.htm.

3. Award Criteria

The following will be considered in making funding decisions:

4. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 http://grants.nih.gov/grants/funding/2590/2590.htm, annually 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 the NIGMS Grants Management Office. For the awards of this program, there is no specific page limit or format requirement on the progress report at this time. However, the progress reports should include at least the following information: an overview of the major achievements made in the previous year including status on meeting the milestones, center development and management activities, research progress, outreach activities, training activities, data and resources 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:

Dr. James J. Anderson
Center for Bioinformatics and Computational Biology
National Institute of General Medical Sciences, NIH
45 Center Drive, Room 2As.25A, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-0943
FAX: (301) 480-2228
Email: andersoj@nigms.nih.gov

and

Dr. Jiayin (Jerry) Li
Center for Bioinformatics and Computational Biology
National Institute of General Medical Sciences, NIH
45 Center Drive, Room 2As.19F, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-0682
FAX: (301) 480-2004
Email: lij@nigms.nih.gov

2. Peer Review Contact:

Dr. Helen R. Sunshine
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 Contact:

Ms. Antoinette Holland
Grants Administration Branch
National Institute of General Medical Sciences, NIH
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.

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity, and dose-finding studies (phase I); efficacy studies (Phase II) efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants. (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

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, 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.

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://grants1.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html). 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/archive/archive/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 that is available at 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 (see 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.

Public 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 public 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 PA 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.

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. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to 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 PA 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.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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