It is critical that applicants follow the instructions in the Research Instructions for the SF424 (R&R) 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. 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.

Part 1. Overview Information
Part 2. Full Text of the 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

The Centers of Excellence in Genomic Science (CEGS) program establishes academic Centers for advanced genome research at U.S. institutions. 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 and/or significantly furthering the application of genomic knowledge, data and methods towards clinical applications. 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.

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 study 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 conceptual frameworks and technologies. Conceiving and implementing 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 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 substantially advance the development of innovative basic, clinically-oriented, and potential future large-scale genomics research projects. The CEGS have explored ways to conduct biomedical research at a genomic scale and have developed new concepts, methods, approaches, tools, or technologies to make possible novel analyses of biomedical questions from a genomic perspective. The resources needed to conduct the multi-faceted, multidisciplinary 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 provides an opportunity for applicants to assemble the teams of investigators from diverse disciplines that will be required to approach biomedical 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.

A CEGS will develop new approaches that will foster the integration of genomics with biomedical research. It will advance the state of the art in applying genomic approaches to biomedical studies: by developing new genomics concepts, methods, technologies, or ways to analyze data; or by investigating novel ways to apply existing genomic-scale, comprehensive technologies to study a biological problem. It must be tightly focused on a single biomedical problem or on an approach to solving biomedical 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 grant application is expected to describe 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 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, it is expected that the product or its precursors (e.g., publications, methods, data) will become 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 might solve some of the problems on which a CEGS project has set its sights; 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, projects must include 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 activities of the program must be synergistic and interdependent, not simply related; each activity must produce results that are required for progress by the other activities. Applications that employ state-of-the-art science that fills in knowledge but does 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 encourage 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. 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 staff very early in the application development process.

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.

Data, methods and software developed under CEGS support should be released quickly in a way that provides broad access. See the Genomic Data Sharing policy https://www.genome.gov/27562511/nhgri-implementation-of-nih-genomic-data-sharing-policy/

Leveraging of genomic resources: Preference will be given to the development of genomic methods for eukaryotes for which 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], GTEx (Genotype-Tissue Expression) [https://commonfund.nih.gov/GTEx], the Mammalian Gene Collection [http://mgc.nci.nih.gov], a Catalog of Published Genome-Wide Association Studies [http://www.genome.gov/26525384], ClinGen (Clinical Genome Resource) [https://www.genome.gov/27558993] 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), the Center may include research that focuses on analysis of such concerns as they relate to the particular research proposed. 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 education and outreach activity. Note that CEGS applications are not required to have an ELSI activity. Information pertaining to NHGRI's Centers of Excellence in ELSI Research (CEERS) program is available at http://www.genome.gov/15014773.

Each CEGS application is required to include an education and outreach activity that leverages the strengths of the Center and its investigators to further educate interdisciplinary scientists, including students and faculty, who will bring creativity to studying biomedical problems through a genomic approach. There is a shortage of investigators who have the interdisciplinary skills needed to conduct most effectively the types of genome-scale research including concept and methods development described in this FOA. One reason for the lack of adequately qualified personnel is that there are too few environments in which there is active effort to disseminate knowledge of how genomic approaches can most effectively be incorporated into the fundamental design of basic and clinical biomedical research. 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 and application of new genomics approaches to biomedical research.

To maximize the impact of these Centers, they should integrate the education of new investigators and perform outreach to broaden the expertise of established investigators. This might, for example, include plans for investigators who are already accomplished in other fields of research and engineering to acquire expertise in genomics. Graduate students and postdoctoral fellows, at a minimum, should participate in the research; however, such participation alone will be considered insufficient to meet the educational and outreach goals of the CEGS program. Applicants are expected to develop creative approaches, complementing 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 education and outreach 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 opportunities for pre-doctoral students, post-doctoral fellows, and other investigators to develop expertise in genomics. The CEGS will therefore become an additional opportunity, beyond those previously developed by NHGRI (see e.g., http://www.genome.gov/10000950), for expanding the cadre of investigators working in the field of genomics.

NHGRI strongly encourages CEGS programs to participate in the NHGRI's DAP program, "Initiative to Maximize Research Education in Genomics: Diversity Action Plan (R25)" (https://grants.nih.gov/grants/guide/pa-files/PAR-16-345.html), which funds no more than one R25 per institution. Applicants can submit an application for an R25 grant, participate in an R25 currently funded at the applicant institution, or opt-out of having a DAP program with justification as to why the DAP would not be feasible. Non-participation in the DAP program will not affect NHGRI’s decision to fund a CEGS application. Applicants to the CEGS program are strongly encouraged to discuss these DAP options, while they are developing their CEGS research plan, with one of the Scientific/Research contacts listed at the end of the DAP FOA, PAR-16-345.

Renewal grant applications are accepted in this program. 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 CEGS award will not exceed ten years.

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, and not only that which existed at the time of the original application. For a CEGS grant it is not sufficient to maintain course if the state-of-the-art has significantly advanced in relevant areas; for a renewal application, a grant that is merely meeting its originally-proposed goals and timeline would not be sufficient. 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 education and outreach; they will be held to a high standard for this essential CEGS activity.

See Section VIII. Other Information for award authorities and regulations.

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.

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

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

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

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.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

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.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

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

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

It is critical that applicants follow the instructions in the Research Instructions for the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

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:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Lisa Brooks, Ph.D.
Telephone: 301-547-1387
Email: [email protected]

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements for the Research Strategy:

A. CEGS Research Project section is limited to 30 pages

B. Research Management, Education and Outreach is limited to 6 pages

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

Project Summary/Abstract: In addition to other requested information, identify explicitly the new capabilities that are proposed to be developed, and the specific biomedical context in which those capabilities will be developed and studied, as a result of the establishment of the Center.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

To be successful, projects of the scientific and managerial complexity of a CEGS require a substantial amount of one PD/PI's effort. Therefore, while Multi PD/PI applications are permitted, the contact PD/PI will be required to devote at least 3.6 person months annually to the leadership and implementation of the Center.

The PD/PI and other members of the research and education 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.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Specific Aims: In addition to the specific aims of each -- the CEGS Research Project and of the Management, Education and Outreach portions-- identify explicitly the new capabilities that are proposed to be developed, and the specific biomedical context in which those capabilities will be developed and studied, as a result of the establishment of the Center.

Research Strategy: The Research Strategy should consist of the following subsections, uploaded as a single pdf attachment.

A. CEGS Research Project:

The applicant should describe fully the new capabilities that are proposed to be developed, and the specific biomedical 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 Scope of Research section of this FOA.

Describe how success toward the proposed goals would provide, rather than an incremental advance, a substantial step forward that would likely not be achieved through mechanisms other than this CEGS program. Enumerate the innovations. Explain what makes the proposed studies relevant to some of the most challenging biomedical problems that can be studied by using genomic approaches. Specify how the proposed technology, research tools, software, scientific approaches, methods of analysis, etc. will be available and of high utility to other scientists, rather than only to the labs developing those methods.

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.

Describe how the genomic approaches and technologies that are proposed to be developed under CEGS support will be applicable to a wide variety of cell types or organisms, and usable in a global, high-throughput, cost-effective manner. If a model system ? such as a limited number of gene families, regulatory networks, or pathways ? is used to develop the genomic approach, describe how subsequent study will be scalable and broadly applicable to 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.

If an ELSI research project is included, explain how the ELSI research is extensively and effectively integrated with, and highly relevant to, the scientific research project.

B. Research Management, Education and Outreach:

Management Plan: A successful CEGS 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 but instead integrate those functions into the research.

Explain how the scientific and administrative plans mitigate the risks inherent in the highly innovative project. The application should explain how different elements 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 element 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 entities is not required but 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 academia.

The 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 dynamically reallocated, as necessary) to meet those goals, in the context of the rapidly-moving field of genomics. 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 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.

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 application may delay the release of funds for consortium arrangements and interfere with research progress. Peer reviewers, NHGRI 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 as appropriate and consistent with achieving the goals of the program. Please note that institutional sign-off on the grant application signifies that all relevant entities of the institution, including the technology transfer office, have reviewed and approved the document.

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. Such individuals may be named in a renewal application if they were appointed during the initial award period.

Education and Outreach Plan: Referring to the Genomic Education and Outreach Activities goals described in Section I, this section of the application will describe the education and outreach plan, and how activities proposed would broaden the expert base of genomics research scientists, beyond the students who will participate in the research project (e.g., by including established investigators) both at the institution(s) as well as regionally and nationally. This plan may include activities more traditionally thought of as education and training as well as, e.g., dissemination and outreach activities related to the project.

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

The education and outreach activities should be developed with a similar degree of creativity and expertise as is applied to the research concept and strategy. Just as NIH is not specifying a management structure, NIH is also not specifying the precise education and outreach activities that should be undertaken. The activities should build on unique aspects of the research program, the investigators, individuals with credentials in education and training innovation, and the institution. Applicants should explicitly indicate how the plan takes advantage of the unique resources and circumstances of the CEGS in the context of the other local strengths of the institution, and how it is innovative and otherwise different from other education and outreach activities already available at the institution.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
• To the extent that large data sets will be produced in the course of CEGS research, a plan for the rapid deposition of data into such established public databases as may be relevant for the particular data type(s) (e.g., GenBank, dbGaP, GEO) 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 as appropriate. Similarly, applicants should propose specific plans to share materials, methods, technologies, and software generated through the grant as appropriate and consistent with achieving the goals of the program. The plan should be consistent with the NIH Genomic Data Sharing policy (https://gds.nih.gov/03policy2.html)

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

Form only available in FORMS-E application packages for use with due dates on or after January 25, 2018.

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study: All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

This initiative is not subject to intergovernmental review.

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.

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed.

In order to expedite review, applicants are requested to notify the NHGRI Referral Office by email at [email protected] when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Applicants are required to follow our Post Submission Application Materials policy.

In addition, a progress update may be submitted, limited to 2 printed pages.

- 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).

Important Update: See NOT-OD-18-228 for updated review language for due dates on or after January 25, 2019.

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.

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).

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.

Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? 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 be simply 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 some of the most challenging biomedical problems that can be studied effectively by using genomic approaches? Will proposed technology, research tools, software, scientific approaches, methods of analysis, etc. be of high utility to other scientists? Would these studies and the education and outreach activities have a large positive effect on the field of genomics and likely be useful to the larger biomedical research community?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those 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 substantial capability to accomplish both the research and education and outreach activities?

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?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects? 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? Is the plan for resource allocation dynamic and does it match the scientific challenges? Do the education and outreach activities build on strengths of the proposed science and the investigators, and does it serve the research community effectively? 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?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

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?

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.

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 Guidelines for the Review of Human Subjects.

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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.

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.

For Renewals, the committee will consider the progress made in the last funding period and whether the application proposes to sufficiently advance the state of the art.

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

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.

Not Applicable

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).

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) Genomic Data Sharing Plan (GDS).

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

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

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NHGRI 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:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

Applications will be assigned to the appropriate NIH Institute or Center. Applications 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 appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.
• Compliance with resource sharing policies as appropriate.
• Program balance.

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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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

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 terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

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.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

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.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: https://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

Lisa Brooks, Ph.D.
National Human Genome Research Institute (NHGRI)
Telephone: 301-547-1387
Email: [email protected]

Anjene Addington
National Institute of Mental Health (NIMH)
Telephone: 301-443-9869
Email: [email protected]

Ken Nakamura, Ph.D.
National Human Genome Research Institute (NHGRI)
Telephone: 301-402-0838
Email: [email protected]

Lisa Oken
National Human Genome Research Institute (NHGRI)
Telephone: 301-594-5250
Email: [email protected]

Terri Jarosik
National Institute of Mental Health (NIMH)
Telephone: 301-443-3858
Email: [email protected]

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.

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 Part 75.