CENTERS OF EXCELLENCE IN GENOMIC SCIENCE (Modified and reissued, see PAR-05-163) (superceded by PAR-02-021) Release Date: May 30, 2000 PA NUMBER: PAR-00-101 National Human Genome Research Institute Letter of Intent Receipt Dates: For Exploratory Grants (P20): May 1, September 1, January 1 annually For Specialized Center (P50): August 1, 2000, April 1 annually thereafter Application Receipt Dates: For Exploratory Grants (P20): June 1, October 1, February 1 annually For Specialized Center (P50): October 1, 2000, June 1 annually thereafter PURPOSE The National Human Genome Research Institute (NHGRI) is initiating a program to establish new academic Centers for advanced genome research. These Centers of Excellence in Genomic Science (CEGS) grants (P50) will support multi- investigator, interdisciplinary teams to develop innovative genomic approaches to address biological problems. The scope of the CEGS program is intended to be broad with a simple unifying theme that the Centers will address important biological problems on a genomic scale. A CEGS may focus, for example, on a particular genome-scale biological problem, on the development of novel technological and computational methods for the production and analysis of comprehensive data sets, or on other ways to develop and use genomic approaches for understanding biological systems. In addition to pursuing research activities, a Center should help to nurture genomic science at its institution, for example, by facilitating the interaction of investigators from different disciplines and by providing training. The NHGRI particularly encourages the formation of new groups of investigators to conduct genomic research. As some newly formed groups may require substantial time and support for development and planning before being in a position to submit a high quality Center grant application, a CEGS Planning Grant (P20) is being offered to facilitate this planning. Applicants intending to focus their Center on bioinformatics approaches may also use the BISTI planning grant (available at: http://grants.nih.gov/grants/guide/pa-files/PAR-00-102.html) in preparation for the CEGS P50 Center grant application. RESEARCH OBJECTIVES Background The NHGRI is currently engaged, along with several other federal, private, and international organizations, in a multi-year research program called the Human Genome Project (HGP). Most of the initial goals of the HGP, including genetic and physical maps of the mouse and human, and the DNA sequences of E. coli, S. cerevisiae, C. elegans, and D. melanogaster have been realized. Others will be met imminently, including the complete human sequence. As of April 2000, more than three-quarters of the human sequence, either in finished or working draft form, has been deposited in the public sequence databases. After generation of a working draft version of at least 90% of the genome, completion of the high quality sequence will follow no later than 2003. Mouse genome sequencing has also begun, with completion of that sequence anticipated no later than 2005. The HGP has been characterized by a focus on large, comprehensive genomic data sets, such as complete DNA sequences and genomic maps, efficient data production, and the development of new technologies. Once the DNA sequence of an organism becomes available, many new avenues to studying its biology are opened. However, new and improved research tools, approaches, and capabilities are needed to discover and use the vast amount of biological information in complete genomic DNA sequences. In 1998, a set of new goals was adopted for the U.S. Human Genome Program (see Goals at http://www.nhgri.nih.gov/98plan/). In addition to completing the human and mouse maps and sequences, the aim of the HGP was extended to developing some of the new data sets and technological approaches that will be necessary to understand and use genomic DNA sequence. The purpose of this new solicitation is to stimulate the development of such new approaches, which are likely to involve computational, instrumental, biochemical, genetic, and analytical technologies. These approaches are likely to require the expertise of teams of investigators from different fields as well as substantial infrastructure. This Program Announcement (PA) signals an augmentation of the NHGRI Center grant program. Previous NHGRI solicitations for Center grants have had as their purpose the production of large data sets, such as genetic maps, physical maps, or DNA sequences, and were derived from the quantitative resource- generation goals of the HGP five-year plans. While such programs continue, this new program is intended to provide support for novel basic genomics research projects. These new Centers will conduct research into biological problems at a genomic scale, or develop new methods, approaches, tools, or technologies to make possible novel analyses of biological questions from a genomic perspective. Some projects may result in new analyses of existing data sets. Other projects may result in technologies and methods that provide the ability to collect, analyze, and present effectively new types of genomic data sets. The NHGRI is committed to continuing to support basic genomic research through investigator-initiated, single-laboratory project grants, using the R01, R21, and other appropriate grant mechanisms, under existing and future programs. However, the resources needed to conduct the multi-faceted, multi-disciplinary projects that may be required to achieve significant advances in these complex problems are sometimes beyond the scope of the typical R01 grant. Therefore, this PA presents an opportunity for applicants to assemble the teams of investigators from diverse disciplines that will be required to approach biological problems using genomics tools in ways that are not possible today. High priority will be given to projects that integrate multi-investigator,"., multi-disciplinary approaches to a scientific problem, especially those that can meld computational and experimental approaches. Scope of Research The U.S. HGP goals for 1998-2003 (Science, Vol. 282, pp. 682 689, 23 Oct. 1998, see http://www.nhgri.nih.gov/98plan/) articulated several areas of genomics for which substantial research opportunities exist. The more recent publication of the Biomedical Information Science and Technology Initiative (BISTI) (http://www.nih.gov/welcome/director/060399.htm) lays out additional challenges, many of which are complementary to those of the HGP. The following excerpts from these reports exemplify the challenges and opportunities that lie ahead: o Sequencing Technology: In the future, de novo sequencing of additional genomes, comparative sequencing of closely related genomes, and sequencing to assess variation within genomes will become increasingly indispensable tools for biological and medical research....[R]esearch must be supported on new technologies that will make even higher throughput DNA sequencing efficient, accurate, and cost-effective, thus providing the foundation for other advanced genomic analysis tools. (HGP goals) o Human Genome Sequence Variation: Natural sequence variation is a fundamental property of all genomes....Basic information about the types, frequencies, and distribution of polymorphisms in the human genome and in human populations is critical for progress in human genetics. Better high- throughput methods for using such information in the study of human disease are also needed. (HGP goals) o Technology for Functional Genomics: The availability of entire genome sequences is enabling a new approach to biology often called functional genomics the interpretation of the function of DNA sequence on a genomic scale....Many genes and other functional elements of the genome are discovered only when the full DNA sequence is known....However, knowing the structure of a gene or other element is only part of the answer. The next step is to elucidate function, which results from the interaction of genomes with their environment....Large-scale characterization of the gene transcripts and their protein products underpins functional analysis....Improved technologies are [also] needed for global approaches to the study of non-protein-coding sequences.... (HGP goals) o Comparative Genomics: Because all organisms are related through a common evolutionary tree, the study of one organism can provide valuable information about others. Much of the power of molecular genetics arises from the ability to isolate and understand genes from one species based on knowledge about related genes in another species. Comparisons between genomes....provide insight into the universality of biologic mechanisms and....into the details of gene structure and function. (HGP goals) o Bioinformatics and Computational Biology: Bioinformatics support is essential to the implementation of genome projects and for public access to their output....Collection, analysis, annotation, and storage of the ever increasing amounts of mapping, sequencing, and expression data in publicly accessible, user-friendly databases is critical to the project"s success. In addition, the community needs computational methods that will allow scientists to extract, view, annotate, and analyze genomic information efficiently. (HGP goals) o 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. (BISTI goals) o The information that biomedical researchers are amassing in profuse quantities today...creates enormous digital repositories of information. The scale of those databases swamps all the information collected before....In order to be useful, the data must be indexed and stored, and the challenges for data analysis and abstraction are formidable. (BISTI goals) The passages quoted above from the U.S. HGP five-year plan and the BISTI report are intended to convey the kinds of subjects and scope of projects that may be appropriate under this Centers program. This PA does not provide a list of examples of possible Center themes because of the NHGRI’s desire not to limit applicants imaginations and to solicit truly new ideas for genomic approaches to biological problems, related to the goals discussed above. The NHGRI strongly encourages investigators who propose to develop such novel approaches to discuss their ideas with NHGRI program staff prior to submitting an application, to ensure that applications will be responsive to the CEGS program. Biomedical research has entered an era in which the solutions to many important problems will require the collection and analysis of large data sets, such as an entire genome, an entire set of expressed RNAs or proteins, an entire gene family from a large number of species, the variation among individuals for a genomic region of substantial size, or a class of gene regulatory or chromatin organizational elements. Therefore, the unifying theme for this program will be that the Centers will address important biological problems on a genomic scale. Preference will be given to approaches and technologies that are applicable to a wide variety of cell types or organisms and that are usable in a high-throughput, cost-effective, comprehensive manner, i.e., are genomic technologies. Similarly, preference will be given to approaches designed to be generally applicable at large scale, for example, not limited to any one genetic locus, specific disease, or organ system. Preference will be given to the development of genomic methods for eukaryotes where genome sequence is available. Methods development or pilot studies using other systems (e.g., eukaryotes whose genomes have not been sequenced, or prokaryotes for which the genomic sequence is known) will be considered with adequate justification, direct applicability to the analysis of eukaryotic genomes must be evident. Where appropriate, integration with other NIH genomics initiatives (e.g., NHLBI genomics program [http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-99-024.html], full-length cDNA [http://www.ncbi.nlm.nih.gov/MGC/], and SNPs [http://www.nhgri.nih.gov:80/About_NHGRI/Der/SNPawardees.htm]) will be considered advantageous. It is anticipated that these Centers may employ large amounts of data to accomplish their goals. However, the application of genomic technologies for data production per se is not the purpose of these Centers. Instead, these Centers may generate data sets to address a biological problem, or may develop tools. The generation of test data sets may be appropriate for developing the methods and technologies, or demonstrating the feasibility of methods under investigation. The cost-effectiveness of the project plan will be a review criterion. Decisions by NHGRI to embark on the large-scale implementation of any new tools developed by these Centers to generate large data sets, particularly when such projects are expensive, will require careful consideration, with advice from the scientific community. Additional Objectives - Training There is a widely recognized shortage of investigators who have the interdisciplinary skills needed to conduct most effectively the types of research described in this PA. o The HGP has created the need for new kinds of scientific specialists who can be creative at the interface of biology and other disciplines, such as computer science, engineering, mathematics, physics, chemistry, and the social sciences. As the popularity of genomic research increases, the demand for these specialists greatly exceeds the supply. In the past, the genome project has benefited immensely from the talents of non-biological scientists, and their participation in the future is likely to be even more crucial. There is an urgent need to train more scientists in interdisciplinary areas that can contribute to genomics. Programs must be developed that will encourage training of both biological and non-biological scientists for careers in genomics....[A] stable academic environment for genomic science must be created so that innovative research can be nurtured and training of new individuals can be assured. (HGP goals) o Strong action by the NIH is required because the existing biomedical research and teaching structures of the universities and research institutions of this country inadequately value interdisciplinary efforts generally, and computation in particular. Few grant programs and fewer academic departments foster the kind of interdisciplinary work required to meet biomedical challenges, let alone educate students about them. National Programs specifically would include formal and informal instruction from the undergraduate through post-graduate levels, and incorporate a range of opportunities for scholars and researchers to participate. (BISTI goals) One reason for the 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 the CEGS program is intended to help to alleviate this shortage by serving as an academic focus for genomic research approaches. To maximize the impact of these Centers, they should integrate the training of young investigators and broadening 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 level. Additional Objectives ELSI In the case of projects that raise ethical, legal, or social concerns (e.g., the study of sequence variation), a component of the Center focusing on analysis of such concerns as they relate to the particular research proposed is encouraged. MECHANISM OF SUPPORT Support of this program will be through the National Institutes of Health (NIH) P50 Specialized Center 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. Genomics is a rapidly changing field, and it is anticipated that most projects that can be initiated now are likely to have a limited lifetime during which support from the NHGRI will be appropriate, either because the project goals will have been accomplished or the Center will have developed to the point that support from another source 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. In general, Centers will receive an administrative site visit during the third year of each competing cycle. The fifth year of funding will depend on the outcome of that administrative review, and the Principal Investigator (P.I.) will receive advice about the NHGRI"s 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 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. Under this cap, it is anticipated that the size of the awards will vary because the nature and scope of research programs proposed will vary. The NHGRI anticipates establishing ten or more such Centers over the next few years, and therefore expects that two to four P50 awards will be made per year. The actual number of awards and level of support will depend on receipt of a sufficient number of applications of high scientific merit and availability of funds. A high priority under this program is the establishment of new academic Centers in which state-of-the-art genomics research can be conducted. At some institutions, the nucleus of a research group that could conduct the research described in this PA 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 will be used when the applicant wishes to request a period of planning and preliminary investigation prior to preparing a P50 Center application. Appropriate activities under the CEGS 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. 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. A planning grant is not required as a precursor to a P50 Center application. Funding of a planning grant does not obligate NHGRI to fund a subsequent P50 Center grant. Applicants anticipating the submission of projects that are largely or exclusively computational should be aware that an additional planning grant opportunity for entry into the CEGS P50 program described here is available. Information on the Planning Grants: National Program for Excellence in Biomedical Computing (Pre-NPEBC) program is available at http://grants.nih.gov/grants/guide/pa-files/PAR-00-102.html. 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 will be considered. GUIDANCE FOR APPLICANTS FOR P50 CENTER GRANTS The applicant should identify clearly in the abstract and more fully in the research plan the new capabilities that are proposed to be developed, or what specific biological question is to be studied, as a result of the establishment of the Center. The synergies achieved through the establishment of multi-disciplinary teams and novel collaborations should be fully described. The P50 grant application should specify the specific administrative and organizational structure(s) that will be used to support the research, and the synergies enabled by those structures. 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 P.I. 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 NHGRI anticipates will characterize these Centers require a substantial amount of the P.I.’s effort to achieve success. Therefore, the P.I. 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 is physically separated from each other (i.e., different departments or institutions), the proposal should address how that separation will be managed. The NHGRI is not specifying a specific organizational structure (e.g., specific numbers of projects and cores) in this PA, 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 CEGS grant. The timeline will also assist the investigators, NHGRI, and its advisors in evaluating progress toward the project"s goals. For those projects for which the investigator deems it appropriate to do so, NHGRI encourages applicants to present explicit, quantitative milestones. The NHGRI 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 CEGS will therefore become an additional mechanism, to those previously developed by NHGRI (see http://www.nhgri.nih.gov/Grant_info/Funding/Training/), for expanding the cadre of investigators working in the field of genomics. Training of racial/ethnic minority individuals, women, and persons with disabilities is a particularly high priority. Data and Materials Dissemination The sharing of materials, data, and software in a timely manner has been an essential element in the rapid progress that has been made in genome research. While Public Health Service (PHS) policy requires that investigators make unique research resources, including DNA sequences and mapping information, readily available when they have been published (NIH Grants Policy Statement, October 1, 1998, p. II-62), the advisors to the NIH and the Department of Energy (DOE) genome programs have encouraged more rapid sharing (http://www.nhgri.nih.gov:80/Grant_info/Funding/Statements/data_release.html). This has become the norm in the genome community. The NIH is interested in ensuring that the information about new methods, technologies, computer software, and genomic biology data that is developed through this program becomes readily available to the research community for further research and development, with the expectation that this 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 the data, materials, and software generated through the grant, taking into consideration the recent Guidance issued by NIH (http://www.ott.nih.gov/policy/rt_guide_final.html). To the extent that established public databases (e.g., GenBank or dbSNP) have the capability for collecting and disseminating the data that would be collected under the grant, it is the NHGRI’s strong preference that a plan for the rapid deposition of data into such public databases be described in the application. The initial 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. LETTER OF INTENT Prospective applicants are asked 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 P.I., names of other key personnel and, if applicable, participating institutions, and the number and title of this PA. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains allows NHGRI staff to estimate the potential review workload and to avoid possible conflict of interest in the review. Please note that applicants planning to request $500,000 or more in direct costs for any year must contact NHGRI program staff before submitting the application (see ADDITIONAL APPLICATION PROCEDURES FOR P50 CENTER GRANTS, below). The letter of intent is to be sent to: Jeffery A. Schloss, Ph.D. Division of Extramural Research National Human Genome Research Institute, NIH Bldg. 31, Room B2-B07 Bethesda, MD 20892-2033 TEL: (301) 496-7531 FAX: (301) 480-2770 Email: jeff_schloss@nih.gov APPLICATION PROCEDURES (P50 AND P20) Applications are to be submitted on the grant application form PHS 398 (rev. 4/98) and will be accepted at the application deadlines indicated on the first page of this PA. Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 435-0714, email: GrantsInfo@nih.gov. The title and number of the PA must be typed on line 2 of the face page of the application form and the YES box must be marked. 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: Scientific Review Branch National Human Genome Research Institute, NIH Bldg. 31, Room B2-B37 Bethesda, MD 20892-2032 TEL: (301) 402-0838 FAX: (301) 435-1580 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. In accordance with NIH policy (NIH Guide for Grants and Contracts, March 20, 1998, available at http://grants.nih.gov/grants/guide/notice-files/not98-030.html), an applicant planning to submit an application requesting $500,000 or more in direct costs for any year MUST contact NHGRI program staff before submitting the application, as plans for the study are being developed, to obtain agreement that NHGRI will accept the application for review. The applicant must identify, in a cover letter sent with the application, the NHGRI staff member who agreed to accept assignment of the application. The NHGRI is not obligated to accept applications requesting more than $500,000 in the absence of such staff agreement. This policy requires an applicant to obtain agreement for acceptance of both any such application and any subsequent amendment. 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 NHGRI. Incomplete applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the PA will be evaluated for scientific and technical merit by an appropriate peer review group, convened by the NHGRI in accordance with the standard NIH peer review procedures. The applications will receive a second- level review by the National Advisory Council for Human Genome Research. 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 CEGS program are evaluated appropriately, the standard NIH review criteria have been adapted to be more appropriate for proposals of the scope described in this PA. 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. Each of these criteria will be considered in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that is not innovative but is essential to move a field forward. Review Criteria for P50 Centers (1) Significance: Importance of the proposed research areas and topics being explored, and their relevance to investigation of a biological problem, particularly one that is amenable to genomic approaches. 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 the 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. (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 a genomic or biological problem. (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 P.I.’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 take 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. (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 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. Review Criteria for P20 Planning Grants (1) Significance: Importance of the proposed research areas and topics being explored, and their relevance to elucidating a biological problem, particularly one that is amenable to genomic approaches. 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 CEGS. (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 take 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. 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. AWARD CRITERIA Applications will compete for available funds with all other recommended applications received through this and other NHGRI programs. The following will be considered in making funding decisions: Quality of the proposed project as determined by peer review, appropriateness of data, materials, and technology sharing plan, availability of funds, and program priority. 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 subpopulations 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 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 "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research" that were published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994, and are available on the web at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not94-100.html. 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 were published in the NIH Guide for Grants and Contracts, March 6, 1998, and are 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. 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, Centers of Excellence in Genomic Science, 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. 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 connect to an Internet site. INQUIRIES Inquiries are strongly encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Jeffery A. Schloss, Ph.D. Division of Extramural Research National Human Genome Research Institute, NIH Bldg. 31, Room B2-B07 Bethesda, MD 20892-2033 TEL: (301) 496-7531 FAX: (301) 480-2770 Email: jeff_schloss@nih.gov Direct inquiries regarding review issues to: Scientific Review Branch National Human Genome Research Institute, NIH Bldg. 31, Room B2-B37 Bethesda, MD 20892-2032 TEL: (301) 402-0838 FAX: (301) 435-1580 Direct inquiries regarding fiscal matters to: Jean Cahill Grants Administration Branch National Human Genome Research Institute, NIH Bldg. 31, Room B2-B34 Bethesda, MD 20892-2031 TEL: (301) 402-0733 FAX: (301) 402-1951 E-mail: jc166o@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.172. 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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