It is critical that applicants follow the Research (R) Instructions in 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

Purpose

The Centers of Excellence in Genomic Science (CEGS) program establishes academic Centers for advanced genome research at U.S. institutions. Each CEGS award supports a multi-investigator, interdisciplinary team to develop transformative genomic approaches to address a biomedical problem. A CEGS project will address a critical issue in genomic science, genomic medicine, or computational genomics, proposing a highly innovative solution that would be a major advance. The research 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, on a genome-scale biomedical problem, or on other ways to develop and use genomic approaches for understanding biological systems or furthering the application of genomic knowledge, data, and methods towards clinical applications. Each CEGS will nurture genomic science at its institution by facilitating the interaction of investigators from several disciplines. By training new and experienced investigators it will expand the pool of genomics scientists and engineers.

Background

The 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, human DNA sequence variation (the HapMap and 1000 Genomes Projects), and 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 concepts, research tools, methods, approaches, and capabilities are needed to discover and use the vast amount of biological information in complete genomic DNA sequences. Therefore, in 2000 NHGRI established the CEGS program (and NIMH joined in 2001) to stimulate the development of such new approaches, which involve computational, instrumental, biochemical, genetic, and analytical conceptual frameworks and technologies. Developing and implementing these approaches require the expertise of teams of investigators from several 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, 470:204-213) (http://www.genome.gov/27543215). Projects supported by the CEGS program are listed at http://www.genome.gov/10001771.

Scope of research

The purpose of the CEGS program is to support the development of highly innovative and transformative basic or clinically-oriented genomic approaches that open up ways to address important biomedical questions. The CEGS have explored ways to conduct biomedical research at a genomic scale and have developed new concepts, methods, approaches, tools, and technologies to allow novel analyses of biomedical questions from a genomic perspective. The resources needed to conduct the multi-faceted, multidisciplinary projects required to achieve substantial advances for these complex problems may be beyond the scope of an R01 award. Therefore, the CEGS program provides an opportunity to assemble the teams of investigators from diverse disciplines that will be required to approach biomedical problems using genomic 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, including those that integrate one or more of computational, experimental, and clinical research approaches.

A CEGS will advance the state of the art in applying genomic approaches to biomedical studies by developing new genomic 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 have 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, with a focus on human biology and disease. A CEGS application is expected to describe a specific and substantive approach, e.g., a concept, method, technology, or way to analyze data. A CEGS should take on the challenging aspects of a problem, including ones that have slowed progress in the research area. Other investigators might solve some of the problems on which a CEGS project has set its sights; a CEGS should be sufficiently nimble to be able to adopt those solutions, so that CEGS resources are applied toward tackling the unsolved challenges.

If the approach is likely to be developed 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 working on solving it, then the project probably doesn t meet the innovation standard required for a CEGS, although highly novel ways to solve the problem may be considered. Applications that use state-of-the-art science that fills in knowledge but does not break substantially new ground are not appropriate for this FOA; neither are applications that support research groups studying related problems but not focused on a specific coordinated approach.

Proposing to change the way genomic science will be done entails a substantial level of risk because the research will, by definition, not be incremental. To balance this risk, projects must include well-developed scientific and management plans to achieve a high pay-off result. Collaborations to develop genomic approaches require proficiency in several disciplines; a CEGS application should engage specialists in a wide range of fields such as biology, genetics, clinical medicine, physical sciences, statistics, mathematics, computer science, and engineering, as needed. The various activities of the program should be synergistic and interdependent, not simply related; each activity should produce results that are required for progress by the other activities.

This FOA does not list examples of possible CEGS themes because of the desire not to limit applicants' imaginations and to encourage new ideas for genomic approaches to biological problems. Solving many important biomedical problems requires the collection and analysis of large data sets, such as many whole genomes, all expressed RNAs or proteins along with those genomes, entire gene families from many species, numerous gene regulatory or chromatin organizational elements for multiple cell states, or phenotypic data from many people. Therefore, the unifying theme for this program will be that the Centers will develop approaches to address important biomedical 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 biomedical systems, including, for example, DNA, RNA, 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 new types of genomic data sets.

The genomic approaches and technologies that are developed should be applicable to a wide variety of cell types, organisms, or diseases, and should be usable in a global, high-throughput, cost-effective manner. Methods and concepts that are applicable only to a specific genetic locus, cell type, disease, or organ system will not be supported under this program. Model systems, such as one or a few gene families, regulatory networks, cell types, or diseases, may be used to develop the genomic approach, as long as the approach will be scalable and broadly applicable. To the extent that cost-effective, global approaches can be developed and also applied within the CEGS budget, such application of the new approach is acceptable. However, the budget limits under this FOA may preclude large-scale application of the genomic approach that is being developed.

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

A CEGS may use 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 genomic 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.

Given all of these contingencies, potential applicants are strongly encouraged to contact NHGRI and NIMH staff early in the application development process. NHGRI will support work that uses any appropriate disease or model system that can be applied more generally; NIMH will support work that is related to mental illness or the brain.

Clinical trials (optional): CEGS applications may include activities that fit the clinical trials definition, such as testing whether new genomic assays or integration of genomic and clinical data improve a health outcome. The purpose of this FOA is to support the development of transformative genomic approaches, and is not intended to fund applications whose primary focus is on recruitment and data production for a clinical trial. The definition of clinical trials in NOT-OD-15-015 and https://grants.nih.gov/policy/clinical-trials/definition.htm is not intended to expand the scope of applications accepted by the CEGS program beyond studies that have a major genomic component and relate clearly to the aims of the program. Any applications including clinical trials are required to address the information listed for clinical trials. Applicants are strongly encouraged to discuss their research plans with NHGRI or NIMH program staff prior to submitting their applications.

Since the goal of the program is to stimulate rapid progress in genomics, it is expected that the results (e.g., publications, methods, data) will become available to the community throughout the duration of the award. Methods, data, and software developed under CEGS support should be released quickly in a way that provides broad access. See the Genomic Data Sharing policy at https://www.genome.gov/27562511/nhgri-implementation-of-nih-genomic-data-sharing-policy/ .

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 whose genomic sequence is known) will be considered with adequate justification; the direct applicability of approaches developed in such a project to the analysis of eukaryotic genomes must be evident.

Where appropriate, integration with other NHGRI or NIH genomic 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], or the PhenX Toolkit [http://www.genome.gov/27541903] will be considered advantageous.

For CEGS projects that raise substantial ethical, legal, or social issues (ELSI, e.g., the study of sequence variation in specific populations), the Center may include research that focuses on analysis of ELSI issues as they relate to the research proposed. To be considered for funding as part of the CEGS award, the ELSI research must be integrated with and highly relevant to the research plan. Information on the NHGRI ELSI research program is at http://www.genome.gov/10001618. Information on NHGRI's Centers of Excellence in ELSI Research (CEERS) program is at http://www.genome.gov/15014773. A CEGS application that includes ELSI research should include ELSI scholars in the education and outreach activity. CEGS applications are not required to have an ELSI activity.

Genomics education and outreach activities

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 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 this shortage 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 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, beyond those previously developed by NHGRI (see e.g., http://www.genome.gov/10000950), and thereby to increase the cadre of investigators qualified to participate in the development and application of new genomic approaches to biomedical research.

To maximize the impact of these Centers, they should train 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, coursework). This education and outreach program should take advantage of unique aspects of the research program, the investigators' talents, and other institutional resources to offer innovative, substantive opportunities for pre-doctoral students, post-doctoral fellows, and other investigators to develop expertise in genomics.

Participation of CEGS awardees in the Diversity Action Plan (DAP)

NHGRI strongly encourages CEGS awardees to participate in 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). The DAP application should be submitted only after a CEGS application has been identified for potential funding. Applicants are strongly encouraged to discuss the initial results of their CEGS applications with staff before applying for an R25.

Renewal applications

Renewal grant applications are accepted in this program. Genomics is a rapidly changing field, and it is anticipated that most projects will likely have a limited time 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 support for a CEGS award will be for a maximum of ten years: up to five years for the initial award, and then a renewal. Since a goal of this program is to build genomic capacity at various institutions, a CEGS PD/PI or research group may receive a maximum of ten years of support under this program.

The field of genomics continues to make remarkable advances over short periods of time. Projects seeking a renewal must 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, not only what existed at the time of the original application. It is not sufficient to maintain course if the state of the art has substantially advanced; for a renewal application, a Center that is merely meeting its originally-proposed goals would not be sufficient. Renewal applications, like new applications, should tackle the hardest problems in their area of focus, because those are the problems that are impeding progress in biomedical research. Successful renewals will also have established a track record in genomics education and outreach.

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 from 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:

o Hispanic-serving Institutions

o Historically Black Colleges and Universities (HBCUs)

o Tribally Controlled Colleges and Universities (TCCUs)

o Alaska Native and Native Hawaiian Serving Institutions

o 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)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

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) 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.
• o 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 to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. 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).

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace 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 Research (R) Instructions in the SF424 (R&R) 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.

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 e-mailed 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. For this FOA, the Research Strategy section is limited to 30 pages. The Research Management, Education, and Outreach sections are limited to a combined total of 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 the other requested information, identify 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 PD/PI effort. If multi-PDs/PIs are proposed, each PD/PI is expected to commit sufficient time to serve his/her proposed role, with a minimum aggregate PD/PI effort of 3.6 calendar months.

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 NIH. Funds for travel of up to seven 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 the CEGS Research Project and of the Management, Education and Outreach portions, identify 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 (up to 30 pages):

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. The synergies achieved through the establishment of multi-disciplinary teams and collaborations should also be fully described, as these are central requirements for a CEGS.

The Research Strategy should also describe the rationale, the 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 in the proposed goals would provide a transformative advance that would likely not be achieved through mechanisms other than the CEGS program. List 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 made 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, both in terms of any use of conventional technologies for the collection of trial data sets (if such data collection is required), and how the novel technologies and approaches produced by the CEGS would be applied in the future.

Describe how the genomic approaches and technologies that are proposed to be developed will be broadly applicable, such as to a wide variety of cell types, organisms, or diseases, and usable in a global, high-throughput, cost-effective manner. If a model system such as one or a few gene families, regulatory networks, or diseases 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 can 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 (up to 6 pages):

Management Plan: A successful CEGS grant application will include well-integrated project and management plans. 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.

Explain how the scientific and administrative plans mitigate the risks inherent in the highly innovative project. Explain how the various 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; broad resource sharing plans are still expected, consistent with achieving the goals of the program. .

NIH is not specifying a particular organizational structure for a CEGS, as each applicant should develop the structure that best promotes 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. The CEGS PDs/PIs will need to have the flexibility to shift resources among the existing CEGS investigators, and to add or eliminate positions and research topics as needed.

A timeline for the project should be presented. This timeline should outline how the project's goals can be met within the timeframe of a CEGS award. The timeline will also assist the investigators, NIH, and their advisors in evaluating progress toward the project's goals. For those projects for which it is appropriate, applicants are encouraged to present 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 application. If the collaborations supported under the grant will involve commercial entities, the effect this will have on the 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 application may delay the release of funds for consortium arrangements and interfere with research progress. Peer reviewers, NIH 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 program. 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. 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 advice and perspectives on progress that the CEGS is making in the 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, to avoid limiting the pool of reviewers. Such individuals should 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 the activities proposed would broaden the expert base of genomic research scientists beyond the students who will participate in the research project (e.g., by including established investigators) at the institutions 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 that does not yet have substantive programs in genomics, or that a new program will add substantial value to the genomic capabilities that exist at an institution in which genomics is already well established.

The education and outreach activities should be developed with a similar degree of creativity and expertise as for 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 explain how the plan takes advantage of the unique resources and circumstances of the CEGS in the context of 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.

Letters of Support: Include letters of support from any person or group that is supposed to provide the proposed project with resources, such as materials, data, or software. Applicants should include letters only from those offering specific resources and collaborations, rather than many letters of general support, to avoid unnecessarily limiting the pool of non-conflicted reviewers.

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 modifications: Applicants are expected to provide Resource Sharing Plans (Genomic Data Sharing Plan, Data Sharing Plan, Sharing Model Organisms, Software Sharing Plan), if appropriate for the resources proposed.

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Prior to funding, NIH program staff may negotiate modifications to the Resource Sharing Plans with the applicant.

Genomic Data Sharing Plan: Applicants are expected to comply with the NIH Genomic Data Sharing Policy, if appropriate. Applicants should provide a Genomic Data Sharing Plan containing the elements listed here https://gds.nih.gov/03policy2.html and the NHGRI implementation of this policy https://www.genome.gov/27562511/nhgri-implementation-of-nih-genomic-data-sharing-policy/ .

Data Sharing Plan: NIH expects that data, metadata, and technical protocols produced under this FOA will be deposited as appropriate into existing, publicly available data repositories that are easily accessible, in machine-readable formats. For any data produced, applicants should describe the data types, where the data and metadata will be deposited, the timeline and plans for data deposition, and the obtaining of broad consent for any human subjects data. For data types that lack suitable public repositories, applicants should indicate their willingness to identify an appropriate alternative solution. Applicants should ensure that data and other information produced or distributed by the resource follow the FAIR (Findable, Accessible, Interoperable, and Reusable) principles.

Protocol and Reagent Sharing Plan: NIH intends that protocols and reagents produced under this FOA be broadly available, distributed at minimal cost, and without undue intellectual property constraints. Where appropriate, applicants should discuss plans for distributing non-data resources that will be produced, including models, protocols, biomaterials, and reagents.

Software Sharing Plan: A software sharing plan, with appropriate timelines, is expected in applications that are developing software. There is no prescribed single license for software produced in this project; however, reviewers will be asked to evaluate the software sharing plan based on its likely impact. A sharing plan guided by the following principles is thought to promote the largest impact:

1. The software should be freely available to biomedical researchers and educators in the non-profit sector, such as education institutions, research institutions, and government laboratories.

2. The plan should permit the dissemination and commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages.

3. To preserve utility to the community, the software should be transferable such that another individual or team can continue development if the original investigators are unable to do so.

4. The terms of software availability should include the ability of researchers outside the awardee group and its collaborating projects to modify the source code and to share modifications with other colleagues as well as with the awardee group. Applicants should take responsibility for creating the original and subsequent official versions of a piece of software.

5. Applicants should propose a plan to manage and disseminate the improvements or customizations of their tools and resources by others. This proposal may include a plan to incorporate the enhancements into the official core software, may involve the creation of an infrastructure for plug-ins, or may describe some other solution.

Appendix:

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) 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 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

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

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 How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. 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.

Add modifications only if your FOA will deviate from the Policy by adding bullets describing the modification

Applicants are required to follow the instructions for post-submission materials, as described in the policy, with the exceptions listed below:

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 e-mail 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).

Any instructions provided here are in addition to the instructions in the policy.

Only the review criteria described below will be considered in the review process.

Applications submitted to the NIH in support of the NIH mission 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 the prior research that serves as the key support for the proposed project rigorous? 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, even transformative, 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 using genomic approaches? Will the 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?

In addition, for applications proposing clinical trials

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

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?

In addition, for applications proposing clinical trials

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

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 substantially higher than is typical for investigator-initiated NIH grants? Is the risk adequately mitigated by the quality of the scientific and management approaches? Does the level of scientific complexity and integration required for success exceed that which would routinely be supported under other grant mechanisms?

In addition, for applications proposing clinical trials

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed 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 the combined efforts of the various investigators and organizational components? Are the plans adequate for monitoring and ensuring high data quality and cost reduction? Are the timelines and milestones (if included) 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, investigators, and institution, and do they serve the research community effectively? If ELSI research is proposed, does the ELSI research 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 individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

In addition, for applications proposing clinical trials

Does the application adequately address the following, if applicable

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

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?

In addition, for applications proposing clinical trials

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

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.

Study Timeline:

Specific to applications proposing clinical trials

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate? Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

For research that involves human subjects but does not involve one of the 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 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.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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 individuals of all ages (including children and older adults) 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.

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 on the basis of established PHS referral guidelines 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.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration of all trials whether required under the law or not. For more information, see http://grants.nih.gov/ClinicalTrials_fdaaa/

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that the application as well as all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

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.

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 https://www.hhs.gov/civil-rights/for-individuals/section-1557/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 https://www.hhs.gov/civil-rights/for-individuals/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.

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.

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 RPPR, 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, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Adam Felsenfeld, Ph.D.
National Human Genome Research Institute (NHGRI)
Telephone: 301-480-2269
Email: [email protected]

Tara Dutka, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-451-3074
Email: [email protected]

Ken Nakamura, Ph.D.
National Human Genome Research Institute (NHGRI)
Telephone: 301-402-8823
Email: [email protected]

Anneliese Galczynski
National Human Genome Research Institute (NHGRI)
Telephone: 301-443-4935
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.