Department of Health and Human Services


Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Human Genome Research Institute (NHGRI)
National Institute of Mental Health  (NIMH)

Funding Opportunity Title

Centers of Excellence in Genomic Science (CEGS) (P50)

Activity Code

P50 Specialized Center

Announcement Type

Reissue of PAR-10-202

Related Notices

None

Funding Opportunity Announcement (FOA) Number

PAR-13-198

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.172; 93.242

Funding Opportunity Purpose

The Centers of Excellence in Genomic Sciences (CEGS) program establishes academic Centers for advanced genome research. Each CEGS grant supports a multi-investigator, interdisciplinary team to develop innovative genomic approaches to address a particular biomedical problem. A CEGS project will address a critical issue in genomic science or genomic medicine, proposing a solution that would be a very substantial advance. Thus, the research conducted at these Centers will entail substantial risk, balanced by outstanding scientific and management plans and very high potential payoff. A CEGS will focus on the development of novel technological or computational methods for the production or analysis of comprehensive data sets, or on a particular genome-scale biomedical problem, or on other ways to develop and use genomic approaches for understanding biological systems. Exploiting its outstanding scientific plan and team, each CEGS will nurture genomic science at its institution by facilitating the interaction of investigators from different disciplines, and by providing training to new investigators it will expand the pool of professional genomics scientists and engineers. Applicants to the CEGS program are required to submit a parallel application to the “Limited Competition: Initiative to Maximize Research Education in Genomics (R25):  Diversity Action Plan” http://grants.nih.gov/grants/guide/pa-files/PAR-13-063.html.

Key Dates
Posted Date

April 12, 2013

Letter of Intent Due Date(s)

June 8, 2013

Application Due Date(s)

July 8, 2013)

AIDS Application Due Date(s)

Not Applicable)

Scientific Merit Review

October-November 2013

Advisory Council Review

January 2014

Earliest Start Date

April 2014

Expiration Date

July 9, 2013

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS 398 Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. While some links are provided, applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

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

Table of Contents

Part 1. Overview Information
Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement


Section I. Funding Opportunity Description


Purpose

The Centers of Excellence in Genomic Science (CEGS) program establishes academic Centers in the United States for advanced genome research, using the P50 Specialized Center mechanism. Each CEGS grant supports a multi-investigator, interdisciplinary team to develop innovative genomic approaches to address a particular biomedical problem. A CEGS project will address a critical issue in genomic science or medicine, proposing a solution that would be a very substantial advance. To achieve such advances, the research conducted at these Centers will entail substantial risk, balanced by outstanding scientific and management plans and very high potential payoff.  A CEGS will focus on the development of novel technological or computational methods for the production or analysis of comprehensive data sets, or on a particular genome-scale biomedical problem, or on other ways to develop and use genomic approaches for understanding biological systems. An extraordinary level of synergy, integration, and potential for advancement of genomics is expected from each CEGS project.  This mechanism will be used only for projects that could not be achieved by using other, more standard grants mechanisms. Exploiting its outstanding scientific plan and team, each CEGS will nurture genomic science and/or genomic medicine at its institution by facilitating the interaction of investigators from different disciplines, and, by providing training of new investigators it will expand the pool of professional genomics scientists and engineers. Applicants to the CEGS program are required to submit a parallel application to the “Limited Competition: Initiative to Maximize Research Education in Genomics (R25):  Diversity Action Plan” http://grants.nih.gov/grants/guide/pa-files/PAR-13-063.html.

Background

The initial goals of the Human Genome Project (HGP) were met with the completion of the mapping and sequencing of the human genome and the genomes of several important model organisms. The HGP and the related genomic research supported by NHGRI have been characterized by a focus on efficient data production, the development of new technologies, and large, comprehensive genomic data sets such as genomic maps and complete DNA sequences, catalogs of human DNA sequence variation (e.g., the HapMap and 1000 genomes projects) and projects to annotate all of the functional elements of the human genome (ENCODE). Once the DNA sequence of an organism becomes available, many new avenues to studying its biology are opened. However, new and improved concept development, research tools, methods, approaches, and capabilities are needed to discover and exploit the vast amount of biological information in complete genomic DNA sequences. Therefore, in 2000, NHGRI established the CEGS program, and was joined in 2001 by NIMH, to stimulate the development of such new approaches, which involve computational, instrumental, biochemical, genetic, and analytical technologies and conceptual frameworks. These approaches require the expertise of teams of investigators from different fields as well as substantial infrastructure. Some of the many important opportunities in genomics are described in “Charting a course for genomic medicine from base pairs to bedside” (Nature, 2011, 470:204) (available at http://www.genome.gov/27543215). Examples of projects that have been supported under the CEGS program to date can be found at http://www.genome.gov/10001771.

The CEGS program extends NHGRI's and NIMH’s research programs in new directions. For example, the Institutes continue to support research to generate comprehensive data sets, and are 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 purpose of the CEGS program is to provide support for the development of innovative, basic and potential large-scale genomics research projects. The CEGS have explored ways to conduct biological research at a genomic scale and have developed new concepts, methods, approaches, tools, or technologies to make possible novel analyses of biological questions from a genomic perspective. The resources needed to conduct the multi-faceted, multi-disciplinary projects that may be required to achieve significant advances for these complex problems are sometimes beyond the scope of the typical R01 grant. Therefore, the CEGS program 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 otherwise are not possible. High priority will be given to projects that integrate multi-investigator, multi-disciplinary approaches to a focused scientific problem, especially those that can merge computational with experimental approaches.

Scope of Research

A CEGS will develop new approaches that will foster the integration of genomics with biomedical research. It will investigate novel ways to apply existing genomic-scale, comprehensive technologies to studying a biological problem, or develop new concepts, methods, technologies, or ways to analyze data, that will advance the state of the art in applying genomic approaches to biomedical studies. It must be tightly focused on a single biological problem or on an approach to solving biological problems, using genomic concepts and methods.

The research plan for a CEGS must encompass a very high level of innovation. The product of CEGS research is expected to dramatically enhance the biomedical research community's capabilities for conducting comprehensive, cost-effective, high-throughput biomedical studies related to the DNA sequence and sequence products of organisms, with particular focus on human biology and disease. A CEGS project is expected to lay out a specific and substantive “product” – e.g., a concept, method, technology or way to analyze data – that can be identified as having been the outcome of CEGS funding. NHGRI and NIMH will consider funding such an effort up to a maximum of ten years, but as the goal of the program is to stimulate rapid progress in genomics, we are interested in the “product” or its precursors (e.g., publications, methods, data) becoming available to the community throughout the duration of the grant; thus active and early sharing of data and resources is a central tenet of the program. In achieving that product, a CEGS has the obligation to take on challenging aspects of a problem, including ones that have slowed progress in the chosen area of research. Other investigators are likely to solve some of those problems during the ten-year duration of a CEGS; a CEGS should be sufficiently nimble as to be able to adopt those solutions, so that CEGS resources can continually be applied toward tackling the unsolved challenges.  If the product is likely to be generated by other projects over the same timeframe as the proposed CEGS, it is generally not appropriate for a CEGS. If a problem is well recognized in the field and multiple laboratories are engaged in solving it, then the project probably doesn’t meet the innovation standard required for a CEGS, though very specific and novel ways to solve the problem may be considered.

Proposing to change the way genomic science will be done in the future entails a substantial level of risk because the research will, by definition, not be incremental. To balance this risk, the application must present a well-developed scientific and management plan to achieve a high pay-off result. Collaborations to develop genomic approaches require proficiency in several disciplines; a CEGS application should engage the expertise of a multi-disciplinary team, drawing from specialists in a wide range of fields such as biology, genetics, clinical medicine, physical sciences, mathematics, computer science, and engineering, as appropriate for the project. The various components of the program must be synergistic and interdependent, not simply related; each component must produce results that are required for progress by the other components. Applications that employ state-of-the-art science that fill in knowledge but do not break substantially new ground are not appropriate for this FOA.

This FOA does not provide a list of examples of possible Center themes because of the desire not to limit applicants' imaginations and to enourage truly new ideas for genomic approaches to biological problems, as they pertain to the goals discussed above. Biomedical research has entered an era in which the solutions to many important problems require the collection and analysis of large data sets, such as large numbers of entire genomes, all expressed RNAs or proteins along with those genomes, entire gene families from a large number of species, or numerous gene regulatory or chromatin organizational elements for multiple cell states. Therefore, the unifying theme for this program will be that the Centers will address important biological problems in a comprehensive manner and on a "genomic scale." In this context, the term “genomics” is not limited to studies directly related to DNA sequence, but instead encompasses global, comprehensive, high-throughput, cost-effective approaches to studying biological systems, including for example DNA, RNA, proteins, metabolites, and regulatory and biochemical pathways and networks. Some projects may result in new analyses of existing data sets, while others may result in technologies and methods that provide the ability to collect, analyze, and present effectively new types of genomic data sets. The genomic approaches and technologies that are proposed to be developed under CEGS support should be applicable to a wide variety of cell types or organisms, and should be usable in a global, high-throughput, cost-effective manner. Methods and concepts that are applicable only to a particular genetic locus, disease, or organ system will not be supported under this program. Model systems, such as a limited number of gene families, regulatory networks, or pathways, may be used to develop the genomic approach, as long as the approach is scalable and broadly applicable. The grant application must clearly justify how the model study will be expandable beyond the particular model(s) used in the developmental research, to ultimately support global analyses. For example, if a particular pathway is being modeled, the application must explain how the modeling algorithms will be extended to other pathways. To the extent that cost-effective, global approaches can be developed and also applied within the context of the CEGS budget, such application of the new approach is acceptable. However, the budget limits under this FOA may preclude both developing and globally applying the genomic approach that is the subject of the research.

Given all of these contingencies, potential applicants are strongly encouraged to contact NHGRI and NIMH staff very early in the application development process.

NIMH is especially interested in novel genomic approaches that have high potential for accelerating our understanding of the genetic basis of the nervous system and mental disorders. Thus, these systems may provide appropriate models for developing the genomic approach, as described above, and similarly, CEGS project outcomes are generally expected to advance these goals because of their broad applicability.

The cost of collecting global data sets is often very high; therefore, a CEGS application that aims to very significantly reduce the cost of collecting a data set that, today, can be collected only at great expense, could be substantially enabling to the genomics community, and is therefore considered appropriate for this FOA.

It is anticipated that a CEGS may employ large amounts of data to accomplish its goals. However, the application of genomic technologies for data production per se is not the purpose of a CEGS, and the CEGS program is not intended primarily to build infrastructure for the application of current genomics technologies. Applicants may use data sets collected under other funding, if the CEGS project's purpose is to develop novel, integrated analyses that extend the interpretation and utility of those data. Decisions by NIH to embark on the large-scale implementation of any new tools developed by a CEGS to generate large data sets will require careful consideration, with advice from the scientific community.

Leveraging of genomic resources: Preference will be given to the development of genomic methods for eukaryotes where genome sequence and related data are already 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 of methods and concepts developed in such a project to the analysis of eukaryotic genomes must be evident. Where appropriate, integration with other NIH genomics initiatives (e.g., ENCODE (ENCyclopedia Of DNA Elements) [http://www.genome.gov/10005107], 1000 genomes [http://www.genome.gov/27528684], the Mammalian Gene Collection [http://mgc.nci.nih.gov], a Catalog of Published Genome-Wide Association Studies [http://www.genome.gov/26525384], and the PhenX Toolkit [http://www.genome.gov/27541903] will be considered advantageous.

ELSI Objective: For CEGS research projects that raise substantial ethical, legal, or social concerns (e.g., the study of sequence variation in specific populations), a component of the Center focusing on analysis of such concerns as they relate to the particular research proposed may be included. To be considered for funding as part of the CEGS grant, the ELSI research must be extensively and effectively integrated with and highly relevant to the research plan. Current information on the NHGRI ELSI research program is available at http://www.genome.gov/10001618. A CEGS application that includes ELSI research should include ELSI scholars in the training program.  Please note that CEGS applications are not required to have an ELSI component. Information pertaining to NHGRI's Centers of Excellence in ELSI Research (CEERS) program is available at http://www.genome.gov/15014773.

Training Objectives

A CEGS has two related training objectives. The first is the training of all Center-associated investigators, and the broader research community at the institution, in the development and use of genomics approaches to the study of biology and medicine. The second is the training of scientists from diverse backgrounds that are currently underrepresented in genomics. Requirements for both are described in this section. The costs associated with the broader training goals are to be incorporated within the $2 million CEGS direct cost cap. Additional funds may be requested for the training of diverse scientists  from underrepresented backgrounds, as further described below.

1. General Genomics Training Component

Each CEGS application is required to have a training component that leverages the strengths of the Center and its investigators to train the next generation of interdisciplinary scientists who will bring creativity to studying biomedical problems through a genomic approach. There is a widely recognized shortage of investigators who have the interdisciplinary skills needed to conduct most effectively the types of genome-scale research described in this FOA. 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 CEGS program is intended to help to alleviate this shortage by supporting the development of Centers that can serve as U.S. academic foci for genomics, and thereby to increase the cadre of investigators qualified to participate in the development of new genomics approaches to biomedical research.

To maximize the impact of these Centers, they should integrate the training of new investigators and broaden the training of established investigators. This might, for example, include plans to recruit into genomics investigators who are already trained and accomplished in other fields of research and engineering. Graduate students and postdoctoral fellows, at a minimum, should participate in the research; however, such participation alone will be considered insufficient to meet the training goals of the CEGS program. NHGRI and NIMH expect applicants to develop creative approaches, using a combination of the standard training vehicles used by academic institutions (e.g., training grants, fellowships, research education programs, seminar programs, course work) and, in addition, more novel avenues. This training program should take advantage of unique aspects of the research program, the combination of participating investigators' talents, and other unique institutional resources that underpin the CEGS, to offer innovative, substantive training opportunities for pre-doctoral students, post-doctoral fellows, and other investigators. The CEGS will therefore become an additional opportunity, beyond those previously developed by NHGRI and NIMH (see e.g., http://www.genome.gov/10000950 and http://www.nimh.nih.gov/research-funding/training/index.shtml), for expanding the cadre of investigators working in the field of genomics.

2. Diversity Action Plan (DAP)

All CEGS grantees are required to participate in NHGRI’s Diversity Action Plan.

There is abundant evidence that the biomedical and educational enterprise will directly benefit from broader inclusion. Recent studies have supported the argument that diversity enhances the quality of education in multiple settings. Studies have suggested that racially and culturally concordant scientific staff may be more successful in recruiting individuals from minority groups into clinical trials. Racially similar physician-patient dyads also may be related to greater patient satisfaction in ways that could enhance communication and participation in clinical research settings. There is no question that the need for a diverse workforce permeates all aspects of the nation's health-related research effort. 

The very nature of genome and ELSI research demands the inclusion of a diversity of points of view and scientific interests. One of the major emphases of genomics is to investigate how DNA sequence variation affects phenotypic differences, especially differences in susceptibility to disease among various groups. The significant societal ramifications of this research will also need to be addressed. It is clearly desirable to have individuals involved who bring diverse perspectives to this research, including an interest in understanding diseases that disproportionately affect medically underserved populations. Genome research will affect all populations and thus all groups need to participate in setting the research agenda and examining the broader issues raised by it.

CEGS awards will not be made in the absence of a DAP program. If your institution already has a Diversity Action Plan that is funded through NHGRI, contact Scientific/Research staff listed in this FOA. For any CEGS application from an institution at which a DAP has not yet been established, an application must be submitted in parallel with the CEGS application, to the “Limited Competition: Initiative to Maximize Research Education in Genomics (R25): Diversity Action Plan” http://grants.nih.gov/grants/guide/pa-files/PAR-13-063.html.

Renewal Applications

Renewal grant applications are accepted in this program (up to a maximum of 10 years of funding). The criteria for accepting renewals are essentially the same as for new applications. A key issue for evaluating renewals concerns the level of innovation that is expected. CEGS projects are envisioned as taking up to 10 years to complete. In most grant programs, a renewal application for a grant that is meeting its originally-proposed goals and timeline would be considered successful. However, for a CEGS grant it is not sufficient to maintain course.

The field of genomics continues to make remarkable advances over short periods of time.  Projects seeking renewal must continue to propose to advance the state of the art of genomics and its applications to biomedicine, substantially beyond what exists at the time of the renewal application. Renewal applications, like new applications, should tackle the hardest problems in the area of their focus, because those are the problems that are impeding significant progress in biomedical research. Successful renewals will also have established a track record in genomics training in general and in their Diversity Action Plan programs specifically; they will be held to a high standard for those essential CEGS components.

Section II. Award Information
Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New
Renewal
Resubmission

The OER Glossary and the PHS 398 Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NHGRI and NIMH anticipate supporting approximately ten CEGS P50 projects at any one time and therefore up to four P50 awards will be made per year. The total amount awarded and the number of awards will depend upon the quality, duration, and costs of the applications received, and the existing investment in the program. Although the financial plans of NHGRI and NIMH provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Award Budget

Applicants may request up to $2 million direct costs for any year for continuing operations (e.g., personnel, standard laboratory equipment, supplies, travel, consortia, and other expenses). Inflationary adjustments above $2 million will not be allowed. Under this cap, it is anticipated that the size and duration of the awards will vary because the nature and scope of research programs will vary. Because of the unusual nature of these Centers, there may be a need to acquire specialized equipment. Funds for such specialized equipment may be requested in excess of the $2 million operating limit if well justified. Specialized equipment in excess of $500,000 over the life of the grant will generally not be permitted.

Award Project Period

A CEGS grant application may request up to five years of support. 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 as a CEGS 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 not exceed ten years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information


1. Eligible Applicants


Eligible Organizations

Higher Education Institutions

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the PHS 398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

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

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least6 weeks prior to the application due date.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

The CEGS program does not permit multiple PDs/PIs.

Investigators who have previously been the PD/PI of a CEGS grant, or who were involved as leaders of a CEGS grant even if not as the PD/PI, are eligible to submit a new CEGS application if it is on a very significantly different topic. CEGS grants are not renewable.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility


Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

Section IV. Application and Submission Information


1. Address to Request Application Package

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

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the PHS 398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

The letter of intent should be sent to:

Jeffery A. Schloss, Ph.D.
Extramural Researchh Program
National Human Genome Research Institute, NIH
5635 Fishers Lane
Bethesda, MD 20892-9305 (U.S. Postal Service Express or regular mail)
Rockville, MD 20850-9305 (for express/courier service; non-USPS service)
Telephone: (301) 496-7531
Email: schlossj@mail.nih.gov

Application Submission

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

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

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

Ken Nakamura, Ph.D.
Scientific Review Branch
National Human Genome Research Institute, NIH
5635 Fishers Lane
Bethesda, MD 20892-9305 (U.S. Postal Service Express or regular mail)
Rockville, MD 20850-9305 (for express/courier service; non-USPS service)
Telephone: (301) 402-0838
Email: kn24c@mail.nih.gov

Page Limitations

All page limitations described in the PHS 398 Application Guide and must be followed, in addition to the following page limitations to the Research Strategy section of each component of the application.

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in the PHS398 Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

CEGS Research Project

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions, as noted.

Face Page (Project)

All instructions in the PHS 398 Application Guide must be followed.

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells (Project)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:   

Description: In addition to other information, the applicant should identify clearly in the abstract the new capabilities that are proposed to be developed, and the specific biological context in which those capabilities will be developed and studied, as a result of the establishment of the Center.

Table of Contents (Project)

All instructions in the PHS 398 Application Guide must be followed.

Detailed Budget for Initial Budget Period (Project)

All instructions in the PHS 398 Application Guide must be followed.

Budget for Entire Proposed Period of Support (Project)

All instructions in the PHS 398 Application Guide must be followed.

Biographical Sketch ( Project)

All instructions in the PHS 398 Application Guide must be followed.

Resources (Project)

All instructions in the PHS 398 Application Guide must be followed.

Research Plan (Project)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Specific Aims: Specific Aims are required.

Research Strategy: The applicant should describe fully the new capabilities that are proposed to be developed, and the specific biological context in which those capabilities will be developed and studied, as a result of the establishment of the Center. The synergies achieved through the establishment of multi-disciplinary teams and collaborations should also be fully described, as these are central requirements for the establishment of a CEGS. The Research Strategy should also describe the experimental rationale and approach and its significance, timelines, contingencies, risky aspects of the research and how that risk will be mitigated, and all of the other aspects of the plan that respond to the characteristics of a CEGS as described in the FOA.

Cost and data quality are central issues in the development and application of genomic approaches.  Therefore, each CEGS application must address these factors and must implement those plans under CEGS support. Cost and quality concerns must be addressed both in terms of any utilization of conventional technologies for the collection of trial data sets within the CEGS research plan (if such data collection is required), and of the manner in which novel technologies and concepts generated by the CEGS would be applied in the future.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS 398 Application Guide, with the following modifications:

The sharing of materials, data, methods, and software in a timely manner has been an essential element in the rapid progress that has been made in genome research. Early in the project, the advisors to the NIH and the Department of Energy (DOE) genome programs encouraged more rapid sharing than had been practiced in most biological research (http://www.genome.gov/10000925). This has become the standard for genome research. In fact, attention to the importance of rapid and wide dissemination of research tools has expanded beyond the genome community. The NIH, as a whole, is interested in ensuring that the information about new methods, technologies, computer software, and as many data developed through federally sponsored research as possible become readily available to the research community as the basis for further research and development. With the expectation that this will stimulate additional research and thus lead more rapidly to information and products that improve the health of the public, the NIH has issued Principles and Guidance that address the issue of data release (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.

This guidance is an integral part of the philosophy of rapid data release in the CEGS program for any large-scale data collection. To the extent that established public databases (e.g., GenBank and dbSNP) have the capability for collecting and disseminating the data that would be collected under a CEGS grant, a plan for the rapid deposition of data into such public databases should be presented in the application. If the established public databases cannot be used for this purpose, applicants should develop and propose specific plans for sharing the data generated through the grant. Similarly, applicants should propose specific plans to share materials, methods, technologies, and software generated through the grant.

The technology transfer practices and policies of the applicant institution, as they relate to resources anticipated to be developed through NIH support of the proposed project, should be described in the CEGS application. If the collaborations supported under the grant will involve commercial entities, the effect this will have on widespread and rapid dissemination of data and materials produced under federal support should also be described. It is to the advantage of applicants and their collaborators to have reached agreement as early as possible on issues related to technology transfer, data and materials dissemination, patenting and licensing, and to describe these plans in the application. Failure to agree on these issues before submitting the grant may delay the release of funds for consortium arrangements and interfere with research progress. Peer reviewers, NHGRI and NIMH staff, and advisors will evaluate the adequacy of dissemination and intellectual property plans prior to award (see below) because this is critical to the purpose of this initiative. Evaluation of annual progress reports and of subsequent renewal applications will also include an assessment of the effectiveness of the sharing of research resources. Please note that institutional sign-off on the grant application signifies that all relevant components of the institution, including the technology transfer office, have reviewed and approved the document.

Management and Training Core

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions, as noted.

Face Page (Core)

All instructions in the PHS 398 Application Guide must be followed.

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells (Core)

All instructions in the PHS 398 Application Guide must be followed.

Table of Contents (Core)

All instructions in the PHS 398 Application Guide must be followed.

Detailed Budget for Initial Budget Period (Core)

All instructions in the PHS 398 Application Guide must be followed.

To be successful, projects of the complexity, both scientific and managerial, that NHGRI and NIMH anticipate will characterize a CEGS require a substantial amount of the PD/PI's effort. Therefore, the PD/PI will be required to devote at least 3.6 person months to the leadership and implementation of the Center.

The PD/PI and other members of the research and training team will be expected to participate in grantee meetings, held approximately annually at grantee sites or near the NIH. Funds for travel of up to five people per grantee meeting may be included in the budget request. Grantees will be expected to host these meetings on a rotating basis, as determined by NIH staff.

Budget for Entire Proposed Period of Support (Core)

All instructions in the PHS 398 Application Guide must be followed.

To be successful, projects of the complexity, both scientific and managerial, that NHGRI and NIMH anticipate will characterize a CEGS require a substantial amount of the PD/PI's effort. Therefore, the PD/PI will be required to devote at least 3.6 Person months to the leadership and implementation of the Center.

The PD/PI and other members of the research and training team will be expected to participate in grantee meetings, held approximately annually at grantee sites or near the NIH. Funds for travel of up to five people per grantee meeting may be included in the budget request. Grantees will be expected to host these meetings on a rotating basis, as determined by NIH staff.

Biographical Sketch (Core)

All instructions in the PHS 398 Application Guide must be followed.

Resources (Core)

All instructions in the PHS 398 Application Guide must be followed.

Cost sharing or institutional support, if any, should be described in this section.

Research Plan (Core)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Specific Aims: Specific Aims are required.

Research Strategy:

Management Plan: A successful P50 grant application will include a well-integrated project plan. The management plan should describe the specific administrative and organizational structure that will be used to support the research, and the synergies enabled by this structure. CEGS 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. Unlike many “centers,” most current CEGS projects do not use service cores.

The application should explain how different components of the organization, including key personnel, will interact, why they are essential to accomplishing the overall goal of the research, and how the combined resources create capabilities that are more than the sum of the parts. Clear evidence that the key investigators will collaborate effectively must be presented in the application. "Centers-without-walls" are welcome under this FOA. However, if any component of a proposed Center is physically separated from the others (i.e., in a different department or institution), the application must address how the effects of that separation will be managed.. Involvement of private sector companies, while not required, is acceptable and may be included to the extent that expertise and resources needed for conducting and disseminating the results of CEGS research may reside outside of academiaThe NIH is not specifying a particular organizational structure for a CEGS, as each applicant should develop the structure that would best promote the proposed research. However, the effectiveness of the proposed structure will be a criterion of the evaluation prior to an award and its implementation will be monitored after an award is made.

The PD/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, as necessary) to meet those goals. In addition to shifting resources among the existing CEGS partners, it may occur, as one set of problems is solved and others arise, that personnel with additional expertise would be needed. But, due to budget limits, that might require reducing or eliminating effort of previously-supported personnel. Working at the “cutting edge” on high-risk projects will require flexibility to accommodate emerging opportunities or to eliminate less productive branches of research. CEGS management must be designed to accommodate such flexibility.

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 NIMH, and their advisors in evaluating progress toward the project's goals. For those projects for which the investigator deems it appropriate to do so, applicants are encouraged to present explicit, quantitative milestones.

CEGS leadership may wish to appoint a team of outside advisors to provide perspectives on progress that the CEGS is making in context of a rapidly advancing field.  NHGRI urges CEGS applicants to describe the function and operation of the proposed advisory board, but not to name individuals who will serve on the advisory board, and not to contact any potential candidates before the application is reviewed.

Training Plan: Referring to the training goals described above (see Scope of Research, Training Objectives), this section of the application will describe the training plan, and how the proposed CEGS training component would broaden the “expert” base of genomics research scientists.

A CEGS application  must demonstrate that an effective program can be established at an institution that does not yet have substantive programs in genomics, or that a new program adds significant value to the genomics capabilities that exist at an institution in which genomics is already well established.

Diversity Action Plan Application: CEGS applicants are required to submit a simultaneous, parallel application to the “Initiative to Maximize Research Education in Genomics (R25)” http://grants.nih.gov/grants/guide/pa-files/PAR-09-245.html.  If your institution already has a Diversity Action Plan that is funded through NHGRI, contact program staff listed in this FOA.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS 398 Application Guide.

Appendix for the Entire Application

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS 398 Application Guide, with the following modification:

·         Include copies of all figures as a pdf file on the CD, so that color and high resolution copies may be uploaded to the application file and provided to reviewers.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 

Information on the process of receipt and determining if your application is considered “on-time” is described in detail in the PHS 398 Application Guide.

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

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

6. Other Submission Requirements and Information

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

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115, with the following modifications:

A progress update may be submitted, limited to 3 printed pages for the CEGS Research Project and 1 printed page for the Management and Training Core. The update is limited to new data supporting the original aims - additional aims or tasks cannot be proposed.  The update must be transmitted as a pdf file, by the Authorized Organization Representative (AOR) of the applicant organization, by email to the Peer Review Contact listed below. The update must be transmitted at least 45 days before the peer review meeting (check your NIH Commons page for the assigned peer review date).   

Section V. Application Review Information


1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact - Overall

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria - Overall

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? If the study is successful, would it simply be an incremental advance, or would it provide a substantial step forward that would likely not be achieved through mechanisms other than this CEGS program? Are these studies relevant to important biomedical problems that can be studied effectively by using genomic approaches? Will technology, research tools, software, scientific approaches, methods of analysis, etc. that are proposed to be developed be of high utility to other scientists? Would these studies have a large effect on the field of genomics and likely be useful to the larger biomedical research community?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Is the level of effort of key personnel adequate? Is there evidence that key personnel can collaborate successfully? Does the team of multi- and interdisciplinary investigators offer novel capability to accomplish the research program?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? Is the level of innovation higher than is typical for investigator-initiated NIH grants? Is the risk adequately mitigated by the quality of the scientific and management approach?  Does the level of innovation, scientific complexity and integration required for success exceed that which would routinely be supported under other grant mechanisms?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? 

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Is there strong synergy among combined efforts of various investigators and organizational components, or could one or more components or investigators be removed without impairing the accomplishment of central goals? Are the plans adequate for monitoring and ensuring high data quality and cost reduction? Are timelines and milestones appropriate? If ELSI research is included, does the ELSI plan adequately leverage the scientific resources of the project, and is it effectively integrated into the research activities of the CEGS?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Is there evidence of institutional support, such as any needed expansion of facilities, improvement of infrastructure, or release from other academic duties where necessary? Is there evidence for a strong training and educational environment?     

Additional Review Criteria - Overall

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.   

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

Not Applicable

Additional Review Considerations - Overall

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.   

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

The CEGS program, and projects that have been funded under this program, are extremely ambitious. Nevertheless, even for applications that receive outstanding impact/priority scores, the budget will be scrutinized with care, and the award may not be for the full amount that the program allows applicants to request.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) at the National Human Genome Research Institute, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

Applications will be assigned to the appropriate NIH Institute or Center and will compete for available funds with all other recommended applications . Following initial peer review, recommended applications will receive a second level of review by the National Advisory Council for Human Genome Research. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information


1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.      

Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

Given the size and complexity of CEGS projects, reporting of scientific progress is anticipated to require substantially more than the standard two page report. In addition to annual written progress reports, grantees will be expected to participate in, and report results at, CEGS grantee meetings held about once a year. An additional progress report may be requested at the time of the third-year administrative site visit.

In general, each CEGS will receive an administrative site visit during the third year of the first competing cycle. Subsequent funding for that cycle will depend on the outcome of that administrative review, and the Program Director/Principal Investigator (PD/PI) will receive advice about the NIH’s interest in accepting a competing renewal application to extend the initial award.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement. 

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

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

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

Scientific/Research Contact(s)

Jefffery A. Schloss, Ph.D.
National Human Genome Research Institute (NHGRI)
Telephone: 301-496-7531
Email: schlossj@mail.nih.gov

Thomas Lehner, Ph.D., M.P.H.
National Instittue of Mental Health (NIMH)
Telephone: 201-443-9869
Email: tlehner@mail.nih.gov

Peer Review Contact(s)

Ken Nakamura, Ph.D.
National Human Genome Research Institute (NHGRI)
Telephone: 301-402-0838
Email: kn24c@mail.nih.gov

Financial/Grants Management Contact(s)

Cheryl Chick
National Human Genome Research Institute (NHGRI)
Telephone: 301-435-7858
Email: ChickC@mail.nih.gov

Rebecca Claycamp
National Institute of Mental Health (NIMH)
Telephone: 301-443-2811
Email: rc253d@mail.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.


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