CENTERS OF EXCELLENCE IN COMPLEX BIOMEDICAL SYSTEMS RESEARCH Release Date: January 26, 2001 RFA: RFA-GM-01-001 National Institute of General Medical Sciences (http://www.nigms.nih.gov/) Letter of Intent Receipt Dates For Planning Grants (P20) and Specialized Center Grants (P50): September 1, 2001 Application Receipt Dates For Planning Grants (P20) and Specialized Center Grants (P50): October 11, 2001 PURPOSE The National Institute of General Medical Sciences (NIGMS) will provide funding for the establishment of new academic Centers of Excellence in Complex Biomedical Systems Research (CE/CBSR). This program is responsive to the Biomedical Information Science and Technology Initiative (BISTI) and its call for National Programs of Excellence in Biomedical Computing (NPEBC). The CE/CBSR goal is to promote the analysis of the organization and dynamic behaviors of complex biological systems. The Center Grant mechanism (P50), together with the Planning Grant mechanism (P20), will support the development of multi-investigator teams capable of engaging biomedical complexity with a scope of activities not possible with other funding mechanisms. Activities will encompass research and training, as well as workshops, symposia, and other forms of outreach. Centers will support research activities that may include the development of new instrumentation and methods, bioinformatics infrastructure, and new theoretical frameworks to advance knowledge of life processes at the system level. Training activities may include programs in computational and information sciences. Workshops and symposia are encouraged, as well as partnering with undergraduate institutions, especially those with substantial numbers of underrepresented minority students. Typical areas of NIGMS interest include computationally- based modeling of processes such as the cell cycle, pattern formation during embryogenesis, the flux of substrates and intermediates in metabolism, and the application of network analysis to understanding the integrated systemic host responses to trauma, burn, or other injury. NIGMS recognizes that biomedical research is entering an era in which computational approaches will be used to deepen our understanding of biological behavior. Building upon mechanistic descriptions of individual biological constituents there will be an increasing emphasis on concepts and methods that target systems and their integrated behavior. Multicomponent, interactive processes at the subcellular, cellular, tissue, and organ levels will be amenable to modeling and simulation in ways previously limited by the lack of adequate data. Traditional molecular and genetic approaches will be augmented with concepts and methods requiring new areas of expertise, particularly from the computational disciplines of engineering, physics, and computer science. The need for quantitative data will likely call for the development of new instrumentation and methods. The organization and representation of these data streams and their relation to preexisting knowledge will require bioinformatics advances, and the development of computer based hypotheses and simulations will require mathematical expertise, as will the development of new theoretical frameworks. The organization of projects incorporating these approaches, and the recruitment of personnel, is not a simple undertaking, and these Centers grants are designed to support these activities. In addition to research contributions, successful Centers will provide their home institutions with the means to implement organizational and professional changes that will make interdisciplinary research in complex biological systems and bioinformatics attractive career options for both established and entry level investigators. The institutions will receive the resources to recruit new investigators who have the skills needed to develop new methods and tools, and to develop appropriate training programs in computational and information sciences. In addition, the Centers will disseminate expertise and knowledge through workshops and symposia, and, because the Centers will be pioneering a new era in biological sciences, they will provide outreach activities to undergraduate institutions, including minority-serving institutions. Current initiatives related to CE/CBSR can be found in prior NIGMS program announcements: http://www.nigms.nih.gov/funding/complex_systems.html. Some groups interested in the scope 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. 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, Centers of Excellence in Complex Biomedical Systems Research, 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. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. Applications from foreign institutions and for-profit organizations will not be accepted, however, subcontracts to foreign institutions and for-profit organizations may be included. MECHANISM OF SUPPORT Support of this program will be through the National Institutes of Health (NIH) P50 Specialized Center Grant and P20 Exploratory Grant mechanisms. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. A P50 Center grant application may request up to five years of support. The length of award will be determined through the peer review and Council advisory processes. Most projects that can be initiated now are likely to have a limited lifetime during which support from the NIGMS will be appropriate, either because the project goals will have been accomplished or the Center will have developed to the point that support from other sources will be more appropriate. Therefore, the total length of support for any P50 Center under this program will be limited to no more than ten years. The anticipated award date is July 1, 2002. Centers 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 Principal Investigator (PI) will receive advice about NIGMS interest in accepting a competing renewal application to extend the initial award. The requested budget for a Center may be up to $2 million direct costs per year (including F&A costs for subcontracts) for continuing operations (e.g., personnel, supplies, travel, and other expenses). Funds for initial large equipment may be requested in excess of this $2 million limit if well justified. It is anticipated that the size of the awards will vary because the nature and scope of research programs proposed will vary. NIGMS anticipates establishing two or three such Centers in fiscal year 2002. The actual number of awards and level of support will depend upon receipt of a sufficient number of applications of high scientific merit and availability of funds. The Principal Investigator of Center Grant must commit a minimum effort of 30%. NIGMS expects to reannounce this RFA. Revised applications will be accepted at that time. At some institutions, the nucleus of a research group that could conduct the research described in this RFA may already exist, and such groups will be able to submit suitable applications for this program directly. However, some groups of investigators may need an opportunity to establish themselves and formulate plans in preparation for submitting a Center application. The Exploratory Grant (P20) mechanism can be used when the applicant wishes to request a period of planning and preliminary investigation prior to preparing a P50 Center application. The planning grant budget may request funds for partial salary of key investigators, travel, and some supplies and equipment. Planning grants will be awarded for up to three years at a direct cost not to exceed $150,000 per year. While there is no minimum effort requirement for the Principal Investigator of a Planning Grant, an appropriate commitment must be made. A planning grant is not required as a precursor to a P50 Center application. Funding of a planning grant does not obligate NIGMS to fund a subsequent P50 Center grant. FUNDS AVAILABLE For FY 2002, a minimum of $5 million will be committed to fund P50 Center applications submitted in response to this RFA. It is anticipated that about 2-3 Centers will be funded, however, this funding level is dependent upon the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of NIGMS, the award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. 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. Examples of first attempts to understand these phenomena can be found at all levels of biological organization, including the modeling of the circuitry of bacteriophage lambda regulation, the modeling of the yeast cell division cycle, and the quantitation of cellular processes such as metabolic flux and response to stress. At higher levels of organization, modeling approaches are being used to understand the orderly development of biological pattern in model organisms such as Drosophila. 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 recent advances in acquiring data of the necessary quality and quantity to permit computer based modeling. Among the most striking recent examples is the availability of complete DNA sequences for a number of organisms, including humans. This advance has made it feasible to generate a truly comprehensive parts list for any organism. Potentially, the enumeration of all the informational units of the genomes (protein coding regions, regulatory elements), their processed forms, and their positional significance, should be possible and, for some microorganisms, close at hand. However, the task of assigning functions to all these elements is formidable. Currently, 30-40% of newly identified coding regions have no known relatives in existing indices of function, and the identification of regulatory elements presents a substantial informatics challenge. Much progress is being made in adapting existing methods (such as gene inactivation) to high- throughput functional analysis, and developing newer computational approaches grounded in evolutionary theory. A higher order problem presents itself in understanding how the genome-encoded components and the stuff of the living state (metabolites, ions, water) are constituted in networks of interacting molecules with particular distributions in time and space. Advances in imaging techniques and analytic methods promise 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, however, a further hurdle must be cleared. The medical, biotechnological, and other usefulness of this information rests 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. NIGMS currently is committed to supporting 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 are not 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. A variety of organizational models are possible, and it is not the purpose of this announcement to prescribe any particular one. Scope of Research The NIGMS intends to support Centers of Excellence in Complex Biomedical Systems for research areas that 1) are central to its mission, and 2) focus on developing new computational approaches to biomedical complexity. Research areas that historically have been computationally based (e.g., population genetics, molecular structure) are excluded as a focus of this Center program. Research projects focusing on disease processes and their specific organ systems are not eligible. An example of particular interest to NIGMS has been articulated in the planning document, A Vision for the Future: A Complete Picture of the Healthy Cell. [URL: http://www.nigms.nih.gov/news/reports/planning.html] This goal includes all the aspects of complex systems research previously listed - the catalog of structure and function, the understanding of intermolecular linkages that lead to a wiring diagram, and ultimately the understanding of intracellular behavior and intercellular interactions in time and space. NIGMS mission areas for which Centers of Excellence in Complex Biomedical Systems Research would be particularly appropriate include the following: o Pattern formation and developmental processes in model systems (e.g., Drosophila, C. elegans, etc.) o Metabolic networks and the control of the flux of substrates, intermediates, and products in cell physiology o Signaling networks and the regulatory dynamics of cellular processes such as cell cycle and apoptosis, and response to environmental stress o Supramolecular machines, such as the replisome, spliceosome, molecular motor assemblies in cell division and motility o Organ system networks involved in multi-organ failure in shock, trauma, and burn injury NIGMS strongly encourages investigators who propose to develop applications to discuss their ideas with NIGMS program staff prior to submission, to ensure that applications will be responsive to the NIGMS mission and intent for this program. Center Developmental Activities Centers will likely support the development of new mathematical tools, theory, and technologies that foster computational solutions. Examples are network theoretical structures for understanding genetic and physiological regulatory circuitry, systems of equations allowing the description of signaling dynamics, and computer models of morphological changes during development. The substantial bioinformatics challenge of such work has been highlighted in the BISTI report (http://www.nih.gov/about/director/060399.htm): "To make optimal use of information technology, biomedical researchers need, first of all, the expertise to marry information technology to biology in a productive way. New hardware and software will be needed, together with deepened support and collaboration from experts in allied fields. Inevitably, those needs will grow as biology moves increasingly from a bench-based to a computer-based science, as models replace some experiments and complement others, as lone researchers are supplemented by interdisciplinary teams. The overarching need is for an intellectual fusion of biomedicine and information technology." To this end, Centers may include bioinformatics tool development that could include DNA sequence feature search programs, specialized databases, development of data sharing and representation formats, and data mining algorithms. The plan may also include the design of new instrumentation that may be required, for example, to obtain time series measurements of multiple parameters of cell and tissue function, including spatial information by imaging technologies. Centers will also be expected to support training in this emerging discipline. One reason for the current lack of adequately qualified personnel is that there are too few appropriate environments available to support this kind of training. The establishment of Centers under this program is intended to help to alleviate this shortage by serving as an academic focus for systems approaches. To maximize their impact, Centers should integrate the training of young investigators and broaden the training of established investigators. Graduate students and postdoctoral fellows should participate in the research. Additional training activities that leverage strengths of the institution and the research program of the Center are encouraged. Such training could be at the undergraduate, graduate, or professional levels. The NIGMS strongly urges the inclusion of partnering programs that will help minority-serving institutions to develop capabilities in these new arenas. Workshops and courses that may develop from Center activities will serve the wider community of investigators and their institutions by disseminating scientific knowledge and organizational information, and are encouraged under this program. Center Directors may be asked to join a committee to provide feedback on this Centers program. GUIDANCE FOR APPLICANTS FOR P50 CENTER GRANTS The applicant should identify clearly in the abstract and more fully in the research plan the new approaches and collaborations, and the specific biological questions that are to be explored as a result of the establishment of the Center. The synergies to be achieved through the establishment of multi-disciplinary teams and novel collaborations should be fully described. The P50 grant application should specify the administrative and organizational structure(s) that will be used to support the research. It is anticipated that these 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. Projects of the complexity, both scientific and managerial, that NIGMS anticipates will characterize these Centers require a substantial amount of the PI"s effort to achieve success. Therefore, the PI will be required to devote at least 30% effort to the leadership and implementation of the Center. If core facilities or shared resources are required, these should be described, as should their management and service to the research projects. The proposal 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. "Centers-without-walls" are welcome under this solicitation. 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. 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 a CE/CBSR grant. The timeline also will assist the investigators, 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. NIGMS encourages applicants to devise a strategy for the Center"s training component that best takes advantage of the research program, the investigators" talents, and other institutional resources, to offer unique and substantial training opportunities for students and other investigators. The CE/CBSR will therefore augment programs previously developed by NIGMS (see http://grants.nih.gov/grants/guide/pa-files/PAR-99-146.html, http://grants.nih.gov/grants/guide/pa-files/PA-98-082.html) for expanding the cadre of investigators working in computational biology. 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. GUIDANCE FOR APPLICANTS FOR P20 PLANNING GRANTS Appropriate activities under the P20 Planning Grant include the establishment of new multi-investigator or interdisciplinary relationships, exploration of organizational concepts, development of the rationale and research design for the subsequent Center, and the collection of preliminary data. DATA AND MATERIALS DISSEMINATION The NIH is interested in ensuring that the information about new methods, technologies, computer software, and high-throughput functional data that are developed through this program become readily available to the research community for further research and development. Such sharing will eventually lead to information and products that improve the health of the public. For this reason, applicants should develop and propose specific plans for sharing of data, materials, and software generated through the grant, taking into consideration the recent Guidance issued by NIH (http://www.nih.gov/od/ott/RTguide_final.htm). 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 be described in the application. The scientific review group will comment on the proposed plan for sharing and data release. The adequacy of the plan will also be considered by NIH staff as one of the criteria for award. The proposed sharing plan, after negotiation with the applicant when necessary, will be made a condition of the award. Evaluation of renewal applications will include assessment of the effectiveness of data, materials, and software release. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS 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 biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are 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 research involving human subjects should read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html), a complete copy of the updated Guidelines are available at: http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm: The revisions relate to NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to 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) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. 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 was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. 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. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. LETTER OF INTENT Prospective applicants are encouraged to submit a letter of intent that includes a descriptive title of the proposed research, the name, address, telephone number, and e-mail address of the PI, names of other key personnel and, if applicable, participating institutions, and the number and title of this RFA. The letter of intent is not binding, and does not enter into the review of subsequent applications. However, the information that it contains allows NIGMS staff to estimate the potential review workload and to plan the review. The letter of intent is to be sent by September 1, 2001, to: James J. Anderson, Ph.D. Division of Genetics and Developmental Biology National Institute of General Medical Sciences Bldg. 45, Room 2AS-25A Bethesda, MD 20892-6200 TEL: (301) 594-0943 FAX: (301) 480-2228 Email: andersoj@nigms.nih.gov APPLICATION PROCEDURES (P50 AND P20) Applications are to be submitted on the grant application form PHS 398 (for newly revised version see: http://grants.nih.gov/grants/funding/phs398/phs398.html) and must be received by the application deadlines indicated on the first page of this RFA. Application kits are available at most institutional offices of sponsored research and may be obtained from: Division of Extramural Outreach and Information Resources National Institutes of Health 6701 Rockledge Drive, MSC 7910 Bethesda, MD 20892-7910 TEL: (301) 710-0267 Email: GrantsInfo@nih.gov The RFA label available in the PHS 398 (rev. 4/98) application form must be affixed to the bottom of the face page of the application. 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 title and number of the RFA must be typed on line 2 of the face page of the application form and the YES box must be marked. The sample RFA label available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to allow for this change. Please note this is in pdf format. Submit a signed 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 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application, including all appendices, must be sent to: Helen R.Sunshine, Ph.D. Office of Scientific Review National Institute of General Medical Sciences Bldg. 45, Room 1AS-13F Bethesda, MD 20892-6200 ADDITIONAL APPLICATION PROCEDURES FOR P50 CENTER GRANTS If the Center is to be organized into projects, then the page limits specified in the PHS 398 form for sections a-d of the Research Plan will apply for each project. If, however, the Center is to integrate its activities in such a way that describing individual projects would not be helpful, then the limit for the narrative section (a-d) is 40 pages. Please note that there is no requirement to submit this maximum number of pages, instead, concise, articulate applications are desired. ADDITIONAL APPLICATION PROCEDURES FOR P20 PLANNING GRANTS The planning activities to be carried out, and the justification for their necessity, should be described in the context of the anticipated P50 Center grant application. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by CSR and for responsiveness by the NIGMS. Incomplete applications will be returned to the applicant without further consideration. 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 the NIGMS in accordance with the standard NIH peer review procedures. The applications will receive a second-level review by the National Advisory Council, General Medical Sciences. Review Criteria The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. To ensure that applications for this CE/CBSR program are evaluated appropriately, the standard NIH review criteria have been adapted to be more appropriate for proposals of the scope described in this RFA. In the written comments reviewers will be asked to discuss the following aspects of the overall application 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 considered in assigning the overall score, weighting them as appropriate for each application. If the Center grant application includes distinct subprojects, the scientific merit of each project will be assessed, based on its merit as an independent effort and its potential importance/contribution to the success of the overall effort. Core facilities and resources will be assessed for their quality, cost- effectiveness, and utility to the overall effort. Overall Review Criteria for P50 Centers (1) Significance: Importance of the proposed research areas and topics being explored, and their relevance to the objective of understanding the organization and dynamics of one or more biomedically important systems. Utility to researchers of any technology, research tools, software, scientific approaches, etc., that are proposed to be developed. Likely effect of the proposed research on the field, and likely impact on the larger biological community. (2) Approach: Quality of the scientific research plan. Likelihood that the proposed research plan will achieve the aims of the proposed research. Appropriateness of the proposed experimental approach, conceptual framework, design, methods, analyses, techniques, and technologies to the proposed research. Acknowledgement of potential problems and consideration of alternative approaches. For proposed multi-component centers, the scientific gain from combining the research components in a center, i.e., the degree of interrelatedness and synergy among the components. (3) Management: Appropriateness and quality of the management plan, including the effectiveness of the management structure. Quality of the plan for deployment of equipment and human resources to attain the research aims and overall Center goals. Organization and coordination of personnel. Quality of the plans for making critical decisions or choices about overall research direction during the project. Where appropriate the cost-effectiveness of approaches used or under development. Adequacy of plans for a Board of Advisors to provide scientific and managerial oversight. (4) Innovation: Novelty or originality of approach, method, technology, experimental design (including presentation, organization, analysis or application of data), conceptual framework, or the insight provided into complex systems. (5) Investigators: Appropriateness of the scientific training, background, and expertise of the Principal Investigator and key personnel to achieving the specific aims and overall goals of the proposed research. Contribution that the individual and combined scientific expertise of the key personnel will make to the achievement of the overall goals of the proposed research. Adequacy of the PI"s ability to lead and coordinate the activities, and develop and implement the management plan, as required for the project"s success. Adequacy of the level of effort of key personnel. (6) Environment: Adequacy of the scientific environment and resources available, including space, equipment, services, infrastructure, and facilities. Degree to which the proposed research plan, experiments, or organization takes advantage of unique features of the scientific environment. Degree of institutional commitment, including any needed expansion of facilities, improvement of infrastructure, and relief from other academic duties where necessary. Environment for training or educational activities, especially for under-represented minorities. (7) Data release and distribution of research tools: Adequacy of plans for dissemination to the scientific community of research tools or research resources (e.g., data sets, computer modeling and simulation software, mutant stocks, DNA libraries) that are proposed to be developed. (8) Training: Quality of the proposed training plan and its likely effectiveness in meeting community needs. Plans to integrate the training components of the Center with other on-going or planned training. Overall Review Criteria for P20 Planning Grants (1) Significance: Importance of the proposed research areas and topics being explored, and their relevance to the objective of understanding the organization and dynamics of one or more biomedical systems. Effect of the proposed areas of research on the field, and the likely impact on the larger biological community. (2) Approach: Quality of the scientific research plan. Likelihood that the proposed planning grant will culminate in the ability of the participants to form an on-going collaboration, generate relevant preliminary data, if appropriate, and submit a competitive application for a CE/CBSR award. (3) Management: Quality of the plan for acquisition, organization, and deployment of equipment and human resources to attain the goals of the exploratory research. Potential success of the proposed exploratory components. Adequacy of the level of effort of key personnel. (4) Innovation: Novelty or originality of the research area being investigated or the methods to be developed. (5) Investigators: Appropriateness of the training, background, and expertise of the P.I. and key personnel to achieving the specific aims and overall goals of the proposed research. (6) Environment: Adequacy of the scientific environment and resources available, including space, equipment, services, infrastructure, and facilities. Degree to which the proposed research plan, experiments, or organization takes advantage of unique features of the scientific environment. Degree of institutional commitment, including any needed expansion of facilities, improvement of infrastructure, and relief from other academic duties where necessary. The environment for training and educational activities. (7) Data release and distribution of research tools: Adequacy of plan to develop a responsive data and tools distribution plan. (8) Training: Adequacy of plan to develop an effective training component that will include under-represented minorities. Additional Review Criteria for P50 and P20 Applications In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o If the application proposes to involve human subjects, then the adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research will be evaluated. Plans for the recruitment and retention of subjects will also be evaluated. o The reasonableness of the proposed budget and duration in relation to the proposed research. o The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application. SCHEDULE Letter of Intent Receipt Dates: September 1, 2001 Application Receipt Dates: October 11, 2001 Peer Review Date: February-March, 2002 Council Review: May, 2002 Earliest Anticipated Start Date: July 1, 2002 AWARD CRITERIA The following will be considered in making funding decisions: o Quality of the proposed project as determined by peer review o Appropriateness of data, materials, and technology sharing plan o Availability of funds o Program priority. INQUIRIES Inquiries are strongly encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: James J. Anderson, Ph.D. Division of Genetics and Developmental Biology National Institute of General Medical Sciences Bldg. 45, Room 2AS-25A Bethesda, MD 20892-6200 TEL: (301) 594-0943 FAX: (301) 480-2228 Email: andersoj@nigms.nih.gov Direct inquiries regarding review issues to: Helen R. Sunshine, Ph.D. Office of Scientific Review National Institute of General Medical Sciences, NIH Bldg. 45, Room 1AS-13F Bethesda, MD 20892-6200 TEL: (301) 594-2881 FAX: (301) 480-8506 Email: sunshinh@nigms.nih.gov Direct inquiries regarding fiscal matters to: Joseph Ellis Grants Administration Branch National Institute of General Medical Sciences, NIH Bldg. 45, Room 2AN-32C Bethesda, MD 20892-6200 TEL: (301) 594-5135 FAX: (301) 480-1969 E-mail: ellisj@nigms.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Nos. 93.821, 93.859, 93.862. Awards are made under authorization of sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-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, and 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.


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