Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Human Genome Research Institute (NHGRI)

National Institute of Mental Health (NIMH)

Funding Opportunity Title
Centers of Excellence in Genomic Science (RM1 Clinical Trial Optional)
Activity Code

RM1 Research Project with Complex Structure

Announcement Type
Reissue of PAR-19-204
Related Notices

NOT-OD-22-190 - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, 2022

Funding Opportunity Announcement (FOA) Number
PAR-22-107
Companion Funding Opportunity
None
Assistance Listing Number(s)
93.172, 93.242
Funding Opportunity Purpose

The Centers of Excellence in Genomic Science (CEGS) program establishes academic Centers for advanced genome research. Each CEGS award supports a multi-investigator, interdisciplinary team to develop integrated, 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 genomics by facilitating the interaction of investigators from several disciplines. Along with its scientific goals, CEGS will also expand the pool of genomic scientists and engineers that can use and apply the novel methods, concepts, and knowledge developed by the CEGS by providing education and outreach experiences to scientists at all career levels. .

Key Dates

Posted Date
March 08, 2022
Open Date (Earliest Submission Date)
May 22, 2022
Letter of Intent Due Date(s)

May 11, 2022

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
June 22, 2022 June 22, 2022 Not Applicable November 2022 January 2023 April 2023
June 22, 2023 June 22, 2023 Not Applicable November 2023 January 2024 April 2024
June 21, 2024 June 21, 2024 Not Applicable November 2024 January 2025 April 2025

All applications are due by 5:00 PM local time of applicant organization. 

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Expiration Date
June 22, 2024
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in 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 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.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Background

The completion of the Human Genome Project (HGP) at the beginning of the century, and the subsequent advent of routine high-throughput technologies for production of genomic data of multiple different types, have revolutionized biomedical science. These advances have led to biological insight in many areas underlying the basis for human health and disease, and more recently have enabled an increasing range of clinical applications. Advances across genomics, and the integration of genomics into biomedical and clinical research and application, are only accelerating. This drives opportunities for development of innovative concepts and new and improved research tools, methods, approaches, applications and capabilities to discover, use and analyze the vast amount of biological information in complete genomic DNA sequences. The NHGRI CEGS program was established in 2000 to stimulate the development of such new approaches. Successful CEGS have been characterized by a high degree of novelty, very high potential impact on the field, an integrated approach, and the ability to take scientific risks in pursuit of a significant advance. CEGS generally require the expertise of a multidisciplinary team of investigators as well as substantial infrastructure.

Scope of research

The purpose of the CEGS program is to support the development of highly innovative and transformative genomic approaches that open up new ways to address important biomedical questions and problems from a genomic perspective. CEGS are intended to explore novel ways to conduct biomedical research at a genomic scale and are expected to develop new concepts, methods, approaches, tools, and technologies. Topics may cover NHGRI’s current broad research portfolio in basic genomic science, data science and computational genomics. Applications proposing advances in genomic medicine are also encouraged. Applications that integrate across multiple areas or major topics are also welcome. Major areas of high-priority research for NHGRI are described in the 2020 NHGRI Strategic Vision. Current projects supported by the CEGS program are listed at http://www.genome.gov/10001771. No matter the area, applications should include all of the hallmarks of a CEGS described herein. This program does not fund projects focused only on Ethical, Legal and Social Implications (ELSI) research; however, in some cases it may be appropriate to include ELSI research as an integrated part of the overall proposal; see below.

This FOA is supported by both NHGRI and NIMH. NHGRI is interested in CEGS applications that broadly cover genomics; NIMH is interested in applications covering genomic aspects of brain and mental health with emphasis on topics as described in the NIMH strategic plan https://www.nimh.nih.gov/about/strategic-planning-reports/sp2020

This FOA does not list examples of all possible CEGS themes to encourage new ideas for genomic approaches to biomedical problems. The unifying theme for this program will be that the Centers will develop novel approaches to address important biomedical problems in a comprehensive manner and on a genomic scale. Even though the CEGS program encourages work on many different topics, successful CEGS have several common features:

Innovation. The research plan for a CEGS must address the high level of innovation expected in a CEGS project, whatever the topic chosen, across the spectrum of NHGRI strategic interests, from basic genomic science technology development, to topics in genomic medicine. Innovation can be conceptual, technological, methodological, analytical, or along some other identified dimension. The innovation can be in ways to produce or analyze comprehensive data sets; ways to solve a particular genome-scale biomedical problem; ways to apply existing genomic-scale; technologies to study a biological problem or surmount a current significant barrier; ways to develop and use genomic approaches for understanding biological systems; and ways to apply genomic knowledge, data and methods towards clinical applications.

If the proposed 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 would not 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. A CEGS should not propose the obvious next step in a project or field, which could be accomplished by assembling state-of-the-art components and innovating at the level of a typical R01.

Advance/Significance. A CEGS proposes a very substantial advance in its proposed topic that will break down barriers, address challenging research projects, or otherwise have broad impact on the field of genomics. A CEGS will often tackle on the challenging aspects of a problem that have slowed progress in that area. Achieving a substantial advance entails a substantial level of risk because the research, by definition, cannot be incremental; this is balanced by the potential for very high payoff and requires an outstanding scientific plan and effective management strategy. A CEGS should be sufficiently nimble to adapt to unexpected outcomes.

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 key NHGRI and NIMH interest areas in genomics, with a focus on human biology and disease or clinical genomics research. A CEGS application is expected to describe a specific and substantive approach, e.g., a concept, method, technology, way to analyze data, way to integrate and apply systems, etc.

As part of the element of high significance, approaches that are developed should be generally applicable, for example to a wide variety of cell types, organisms, diseases/conditions, populations, etc., 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, local institution, 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, or study populations may be used to develop the genomic approach, as long as the approach will be scalable and broadly applicable.

A CEGS may generate large amounts of data to accomplish its goals. However, a project that is focused on the application of genomic technologies for data production per se, or one that is primarily focused on collection of a dataset in the absence of a novel concept or methodological approach is not a CEGS.

A CEGS is not intended to be a program project or infrastructure for an existing program or department. Ideally a CEGS will bring new capabilities to an institution.

Similarly, A CEGS proposing an advance in genomic medicine may incidentally provide valuable individual-level information to physicians and patients. However, 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.

Integration. A CEGS is a tightly focused project. A CEGS will lay out a specific and substantive "product" that can be identified as having been the outcome of CEGS funding. At the same time, CEGS are implemented by a multi-investigator, interdisciplinary team working in a highly integrated fashion. Collaborations to develop new genomic approaches will require proficiency in several disciplines; a CEGS application should engage specialists in a wide range of fields such as biology, genetics, clinical medicine, ethics and policy, physical sciences, statistics, mathematics, computer science, and engineering, as needed. The components of the proposed CEGS should be well-integrated, interdependent, and synergistic, not simply related; each activity should produce results that are required for progress by the other activities. Applications that support research groups studying related problems that are not focused on a specific coordinated approach are not appropriate as a CEGS.

Additional program goals

In addition to these common scientific aspects, the CEGS program is intended to address other important goals, including research education and outreach, , encouraging diversity of researchers and (where applicable) research participants(as described in https://grants.nih.gov/grants/guide/notice-files/NOT-OD-20-031.html ) to be involved in the CEGS, and resource sharing/dissemination.

Education and outreach.. A CEGS will increase the pool of professional scientists and engineers able to work in or use genomics, by offering innovative, substantive education and outreach opportunities across appropriate disciplines. This activity will include both new and established investigators, including those from other disciplines such as engineering or medicine who want to acquire genomics expertise. Graduate students and postdoctoral fellows, at a minimum, should participate in the research; however, that participation alone is insufficient as an education and outreach effort.

Each CEGS application must include an education activity that complements 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, and thereby to increase the cadre of investigators qualified to participate in the development and application of new genomic approaches to biomedical research.

. For education activities, 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 activity 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 related to the reserch topics of the CEGS.

Outreach plans should be complementary to the Aims of the CEGS. Outreach usually includes dissemination of methods and tools to other scientists. Other possible activities could include outreach to communities (e.g., patient communities, populations) affected by the research, or outreach to focus dissemination of new methods and technologies to institutions that have lower levels of investment in genomics.

Diversity of CEGS investigators and participants in education/outreach. NHGRI expects CEGS projects to create and pursue opportunities to improve the participation of underrepresented groups in genomic science and genomic medicine. Opportunities will arise in multiple areas, especially in diversity of research teams applying and diversity of participants in education and outreach activities..

  • Programs are encouraged to build a diverse team of investigators that includes, for example, faculty from under-represented groups as described in detail in the NIH Notice of Interest in Diversity,  women, and faculty at different career stages (i.e., junior as well as senior faculty). Investigators that meet these descriptions are encouraged to apply.

  • Attention should be given to recruiting participants at all academic levels in the CEGS activities from diverse backgrounds, including groups underrepresented in the biomedical, clinical, behavioral and social sciences. . Institutions with funded CEGS are encouraged to apply for NHGRI or other training activities that emphasize diversity, and that may leverage the CEGS and other genomic studies ongoing at the institution.

  • Outreach and dissemination elements of the proposal should be written with attention to reaching scientists from under-represented populations.. For example, outreach activities may include transfer of technologies and methods developed under the CEGS funding; there may be opportunities for outreach that includes minority-serving institutions or those that may be under-resourced for genomic research..

Diversity of research participants. Depending on the Aims of individual projects, opportunities may also exist for diversity of populations studied, research participants, or diversity of patient populations. For CEGS applications that propose Aims relating to human cells, tissues, individuals, or populations, applicants should propose work on subjects or samples deriving from individuals from populations that are under-represented in research studies of the type that the CEGS proposes. Such applications should also consider sex as a biological variable, and sampling from subjects across the lifespan. If appropriate (e.g. where there is an environmental component to the Aims, or in cases where a CEGS proposes work on patient populations), diverse socioeconomic or geographical environments should be considered.

Resource sharing. One goal of the CEGS program is to stimulate rapid progress in genomics. Therefore, it is expected that all products of the funded research will become available to the community throughout the duration of the award. Because the scientific topics covered by CEGS potentially span all areas of NHGRI interest, and will likely produce new data types,, applicants will need to identify the products that are important for dissemination to the community. Products may include biologics such as cell lines and model organisms but also data, publications, methods, software, device plans, informatics/analytic tools; and resources that may be generated (e.g., data servers, cell lines).

Emerging Centers of Excellence in Genomic Science.

In FY 2020 and 2021, the NHGRI budget included funds for “Emerging Centers of Excellence in Genomic Science” (eCEGS), which were intended to fund new CEGS at institutions that previously had not been funded under the program. If future eCEGS funds are available, they will be allocated similarly. Independently of this, NHGRI encourages institutions that have not previously had CEGS funding to consider applying. Please see “Selection Criteria”, below.

Ethical, Legal, and Social research components. For CEGS projects that raise substantial ethical, legal, or social issues (ELSI), 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. 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.

Clinical trials (optional).

CEGS applications may include activities that fit the clinical trials definition, for example those 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 but 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 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 application requirements for clinical trials. Applicants are strongly encouraged to discuss their research plans with program staff listed below in the Contacts prior to submitting their applications.

Renewal applications.

Genomics is a rapidly changing field, and it is anticipated that most projects will 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 one 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. 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 as well as in the sharing of important research resources and data.

Site visits.

Due to the nature and size of CEGS awards, NHGRI Program staff may elect to perform a site visit (in person or virtual), typically early in the third year of the initial award, to help them understand progress relative to the CEGS program goals above, including novelty, significance, and integration of components.

Non-responsive applications.

Applications with the following properties will be considered non-responsive, and will not be reviewed:

  • Applications that do not include a clear justification of scientific advance/significance.
  • Applications that do not include a clear justification of innovation
  • Applications with research groups studying related problems that are not focused and integrated as a specific coordinated approach
  • Applications that propose generation of data sets or resources, in the absence of high levels of innovation, or where the data generation component is not connected to advancing the other Aims.
  • Applications that lack an Education and Outreach section.

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

Section II. Award Information

Funding Instrument

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

Application Types Allowed
New
Renewal
Resubmission

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

Clinical Trial?

Optional: Accepting applications that either propose or do not propose clinical trial(s).

Funds Available and Anticipated Number of Awards

PA/PAR: 

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget

Applicants may request up to $1.5 million direct costs for any year for continuing operations (e.g., personnel, standard laboratory equipment, supplies, travel, consortia, and other expenses). Inflationary adjustments will not be allowed. Budgets must reflect the actual needs of the proposed project.

Award Project Period

A CEGS application may request up to five years of support. The maximum length of support for a Center under this program (with a renewal) is ten years.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

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)

For-Profit Organizations

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

Local 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)

Federal Governments

  • Eligible Agencies of the Federal Government
  • 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
Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed. 

Required Registrations

Applicant organizations

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.

  • 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.
    • 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.
    • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. SAM registrations prior to fall 2021 were updated to include a UEI. For applications due on or after January 25, 2022, the UEI must be provided on the application forms (e.g., FORMS-G); the same UEI must be used for all registrations, as well as on the grant application.
    • Dun and Bradstreet Universal Numbering System (DUNS) – Organization registrations prior to April 2022 require applicants to obtain a DUNS prior to registering in SAM. By April 2022, the federal government will stop using the DUNS number as an entity identifier and will transition to the Unique Entity Identifier (UEI) issued by SAM. Prior to April 2022, 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.
  • eRA Commons - Once the unique organization identifier (DUNS prior to April 2022; UEI after April 2022) is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; 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 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.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

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.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 2.3.7.4 Submission of Resubmission Application. 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 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Although applicant organizations may submit more than one distinct application, it is unlikely that more than one application per institution will actually be funded (see V.2 Review and Selection Process)..

Section IV. Application and Submission Information

1. Requesting an Application Package

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.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in 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.

Letter of Intent

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

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

  • 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:

Stephanie A. Morris, Ph.D.
Telephone: 301-435-5738
Email: morriss2@mail.nih.gov

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

For this specific FOA, the Research Strategy section is limited to 30 pages.

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 this specific FOA, the overall Research Strategy is divided into two main sections:

1. A "Research Strategy- Science" section limited to 30 pages. This is further subdivided into five headed subsections with the following recommended page lengths:

  • Center Rationale and Significance (4 pages)
  • Center Innovation (3 pages)
  • Center Integration (2 pages)
  • Center Approach (18 pages)
  • Center Management Plan (3 pages)

2. A "Research Strategy--Research Education and Outreach" section limited to a combined total of 6 pages.

A separate Resource Sharing plan is required and will be considered in the overall Impact Score.

Instructions for Application Submission

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.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

R&R Budget

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. For single PI applications, a minimum of 3.6 calendar months is required. If multi-PDs/PIs are proposed, each PD/PI is expected to commit sufficient time to serve his/her proposed role, with a minimum combined 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 CEGS 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.

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Research Strategy should include these sections:

1. Research Strategy- Science (up to 30 pages, subdivided into five headed sections with the recommended page lengths):

a. Center Rationale and Significance (4 pages)

b. Center innovation (3 pages)

c. Center integration (2 pages)

d. Center Approach (18) pages)

e. Center Management Plan (3 pages)

Center Rationale and Significance. The Research Strategy should begin with a concise rationale for the proposed center, explicitly describing the significance of the proposed work. 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. Explain what makes the proposed studies relevant to some of the most challenging biomedical problems that can be studied or addressed by using genomic approaches. Describe the utility of the proposed technology, research tools, software, scientific approaches, methods of analysis, knowledge, etc., to the larger biomedical research community.

Describe how the genomic approaches and technologies that are proposed for development will be broadly applicable or generalizable, such as to a wide variety of cell types, organisms, diseases, clinical contexts, etc., and usable in a global, high-throughput, cost-effective manner. If a model system such as one or a few, regulatory networks, or diseases is used to develop the genomic approach, describe how subsequent study will be scalable and broadly applicable to global analyses. Aspects of this may also be detailed in the Center Approach (see below).

Center Innovation. Describe the innovations in technologies, approaches, concepts, or organization of the effort, that are substantially higher than is typical for investigator-initated grants; or any other aspects of innovation as they relate to the main theme of the proposed Center.

Center Integration. This section should describe how the major components of the proposed Center are designed to work with each other, the synergy among the combined efforts of the various investigators and organizational components, and the scientific contingencies and interdependencies between them. A key feature of a CEGS is the interdependencies between the scientific components. Applicants should convey how the scientific complexity and integration required for success exceeds that which would routinely be supported under other grant mechanisms.

Center Approach. Describe the scientific approach including timelines, milestones,  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.

If needed, provide further details about how the approach chosen will demonstrate generalizability, e.g., across biological systems, diseases, clinical applications or settings, or other aspects related to the theme of the proposed Center.

Describe how data will be managed and analyzed and how information will be integrated within the CEGS.

Address cost and data quality 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/or approaches produced by the CEGS would be applied in the future.

If you propose large-scale generation of data sets or resources, justify why the activity has a high level of innovation and how the data generation component connects to advancing the other aims of the CEGS project.

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.

A timeline for the overall project should be included. This timeline should outline how the project's goals can be met within the timeframe of a CEGS award.

Center Management Plan. The Research Strategy must include a well-integrated project management section that goes beyond the multi-PD/PI plan.

Describe the specific administrative and organizational structure that will be used to support the research, and the synergies enabled by this structure, especially considering the multi-disciplinary structure that the program encourages. Consideration of management plans relevant to (but not included in) the Education and Outreach activities (see below) should also be discussed.

Applicants should describe how interactions between the different proposed components/investigators will achieve results that are more than just the sum of the components, as these are central requirements for a CEGS.

Explain how the management/administrative plans mitigate the risks inherent in the highly innovative project. Explain how the various elements of the organization, including key personnel, will interact, and why they are essential to accomplishing the overall goal of the research. Clear evidence that the key investigators will collaborate effectively must be presented in the application. Provide evidence that the interdisciplinary team of investigators is capable of accomplishing the research, research education and outreach activities. 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 may be included, since expertise and resources needed for conducting and disseminating the results of CEGS research may reside outside of academia; comprehensive resource sharing plans are still expected, consistent with achieving the goals of the program.

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 modify research approaches as needed in response to the research findings. The plan should convey how this flexibility will be supported.

Scientific advisors. As part of the Management Plan, CEGS investigators may wish to appoint a team of outside advisors to provide advice and perspectives on progress. While the function and operation of the proposed advisory board should be described in the application, proposed advisors should not be named, and potential advisor candidates should not be contacted prior to the application peer review, to avoid limiting the pool of reviewers. However, such individuals should be named in a renewal application if they were appointed during the initial award period.

Research Strategy- Research Education and Outreach (up to 6 pages, combined): This section will describe a research education and outreach plan, consistent with the description of the goals of the CEGS program described in the Scope of Research/Additional Program Goals  section.

Applicants should apply a similar degree of creativity and expertise to this section as they do to the research concept and strategy for the science.

Describe the overall plan for education and outreach in this project, including information on approaches being used, frequency of activities, and target audience.

Describe approaches to identify and implement opportunities to reach institutions, scientists, trainees and other individuals from diverse backgrounds, including groups underrepresented in the biomedical, clinical, behavioral, and social sciences as part of their education and outreach efforts.

Describe how the education and outreach opportunities build on unique aspects of the research, resources and circumstances of the CEGS program, as well as other local strengths of the institution.

Describe how the CEGS efforts are innovative and otherwise different from other education and outreach activities already available at the institution.

Applicants should describe how the education and outreach activities proposed will have effect on the field of genomics and the larger biomedical research community.As one element of overall Significance, NHGRI expects that CEGS awardees will have plans to ensure that new methods, technologies, etc. and approaches will be made available to researchers outside the CEGS. Please do not duplicate information in the Resource Sharing plans (but you may refer to them).

Describe how the proposed technology, research tools, software, scientific approaches, methods of analysis, knowledge, etc., will be made available to other research or clinical scientists, rather than only to the laboratories developing those methods.

Describe the plans for evaluating the effectiveness of the Research Education and Outreach activities.

One aspect of dissemination that is characteristic of some CEGS is technology transfer. If relevant, the technology transfer practices and policies of the applicant institution should be described in the application. In cases that will involve commercial entities, please describe the effect on dissemination of data and materials produced under federal support. Applicants and their collaborators should reach an agreement on issues related to technology transfer, data and materials dissemination, patenting, and licensing and describe these plans should be in the application. Peer reviewers, NIH staff, and advisors will evaluate the adequacy of dissemination plans prior to award (see below).

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.

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.

The following modifications also apply:

  • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
  • For other research products:
    • NIH anticipates that CEGS topics and “products” will vary widely, so not all Resource Sharing elements (listed below) will apply equally to all CEGS, and some may not apply at all. However, where applicable, applicants must address them.
    • Resource Sharing plans should not duplicate the Outreach or other sections of the main Research Plan but should refer to them when appropriate.

Plan for Data (including Genomic Data) Sharing: Applicants should propose a data sharing plan consistent with this goal that addresses rapid data sharing with the community and describes plans to adhere to the FAIR Guiding principles (Findable, Accessible, Interoperable, Reusable), including:

    • Data and metadata should be assigned unique and persistent identifiers.
    • Data and metadata should be retrievable using standardized protocols/APIs.
    • Data should pass strict quality metrics.
    • Data should have clear provenance.
    • Rich metadata should be collected with all data.

See:

https://www.genome.gov/about-nhgri/Policies-Guidance/Genomic-Data-Sharing

For NIMH-funded awards, see:

https://grants.nih.gov/grants/guide/notice-files/NOT-MH-19-033.html

In general, data should comply with community standards, formats, ontologies, quality metrics, etc. that may have been developed for data of that type (see for example https://www.ga4gh.org/) to enable integration of data between CEGS and other projects. Wherever possible, data should go to an established repository, to be identified in the Resource Sharing Plan. NHGRI expects that some CEGS-produced data types will be sufficiently novel that there is no recognized repository or established standards; in these cases, applicants should describe reasonable provisions for making the data available.

Selection of Biological Samples and Ability to Share Sample Data with Community: Where human biological samples will be studied, they are expected to have been obtained using a documented informed consent process that allows for future research use and broad data sharing. (NOT-HG-20-011). Sources with participant consent for general research use, or unrestricted access, is strongly encouraged. If new human biospecimens will be collected, or if clinical application is included in the application, the consent process should be described at a high level in the Research Plan and detailed in the Human Subjects Section.

Plan for Software and Data Analysis Sharing: NHGRI is committed to the timely release of open-source software and well-documented data analyses including models and tools developed from proposed studies. Applicants should include plans for open dissemination of methods, protocols, software, and tools to the community such that they are readily usable and extensible, where applicable. These should be made freely available to biomedical researchers and educators. There is no prescribed license for software produced by applications responding to this announcement, but any software license selected by applicants should allow for unrestricted redistribution and modification of software.

  • Methods, protocols, tools, and software should be well-documented and where applicable made available via version-controlled public repositories.
  • Solutions that enhance reproducibility when used by the community and ability of the community to integrate into automated pipelines should be emphasized.
  • A software sharing plan should describe how improvements or tool customizations will be managed and disseminated to the scientific community. Applicants should take responsibility for creating the original and subsequent “official” versions of a piece of software.

Plan for Sharing Other Resources: Physical products, materials, and reagents, such as DNA clones and cell lines, model organism lines, or new -omics devices, etc., generated by awardees, should be made available to the research community and such sharing plans should follow the same principles and spirit as data, software, and analysis release plans. The applicant should provide plans for such resource sharing and distribution in the Resource Sharing section. Key factors for this are documentation sufficient to allow use, availability to the community at reasonable cost and on equal terms, and with lack of reach-through with regard to claims on downstream discoveries. Applicants should also propose plans for sharing experimental protocols and methods.

After initial review, NHGRI program staff will conduct an additional administrative review of the plans for sharing data, software, data analysis, and resources and may negotiate modifications of these plans with the prospective awardee. The final negotiated version of these plans will become a term and condition of the award.

Appendix:

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

  • No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined 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.

PHS Assignment Request Form

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

3. Unique Entity Identifier and System for Award Management (SAM)

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

4. Submission Dates and Times

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.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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 fieldof the Senior/Key Person Profile form. 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 unique entity identifier (DUNS number or UEI as required) provided 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. Applications must include an Education and Outreach section in the Research Plan.

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

.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the 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 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).

Section V. Application Review Information

1. Criteria

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.

For this particular announcement, note the following:

Adequacy of Resource Sharing Plans will be considered in the Impact Score. See "Approach" below. Renewal proposals must meet all the CEGS criteria for innovation, significance, integration, and justify why the work still needs to be funded as a CEGS to achieve its goals, instead of one or more R01 grants.

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

Overall Impact

Overall Impact

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

Scored Review Criteria

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?

In addition, for applications involving 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 and/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?
 

Specific to this FOA:

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? Is the proposal relevant to some of the most challenging biomedical problems that can be studied or solved effectively using genomic approaches? Will the proposed technology, research tools, software, scientific approaches, methods of analysis, etc., be available and 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?

In addition, for applications involving 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?
 

For this particular announcementSpecific to this FOA:

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?

In addition, for applications involving 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?

For this particular announcementSpecific to this FOA:

Is the level of innovation substantially higher than is typical for investigator-initiated NIH grants?

 

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? 
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 involving 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 and/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?
 

For this particular announcementSpecific to this FOA:

Is the risk entailed by undertaking highly novel approaches to significant problems in genomics adequately mitigated by the quality of the research strategy and risk management approaches?

Is there strong synergy among the combined efforts of the various investigators and organizational components? Are the proposed research components well-integrated, and are the dependencies among them clear? Are the timelines and milestones (if included) appropriate? Is the plan for resource allocation among Center components dynamic and does it match the scientific challenges?

Does the level of scientific complexity and integration required for success exceed that which would routinely be supported under other grant mechanisms?

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?

Are the plans for managing data (including data processing, analysis, ensuring quality/reproducibility, etc.) adequate?

Does the application describe how key products of the research will be made available? For new technologies, methods, algorithms, concepts, software, approaches, etc. that will be developed, is there appropriate consideration given to how these will be made known to or available to the community?

Are Education and Outreach plans appropriate and are they likely to be successful? Do they creatively take good advantage of the strengths of the proposed CEGS, investigators, and the local institutional environment? Do the investigators identify opportunities for training and outreach that will reach diverse populations, including under-represented groups, or encourage diversity in the genomic research workforce? Will outreach plans lead to the dissemination of novel methods, approaches, and knowledge to the genomics research community?

 

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 involving 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?
 

Additional Review Criteria

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.

 

Specific to applications involving 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.

 

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. Renewal proposals must meet all the CEGS criteria for innovation, significance, integration, and justify why the work still needs to be funded as a CEGS to achieve its goals, instead of one or more R01 grants.

 

Not applicable

Additional Review Considerations

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.

 

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

 

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).

Reviewers will comment on the quality and adequacy of the Resource Sharing Plans for all products of the proposed research.

This may include:

  • Data, including metadata (see Data Sharing Plan; Genomic Data Sharing Plan); if human samples will be used, this includes the ability to share those data e.g., via a repository
  • Software, data analyses and data analysis tools, protocols
  • Physical products, e.g., reagents, cell lines, model organisms (see Sharing Model Organisms)

 

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.

2. Review and Selection Process

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 will receive a written critique.

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.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

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 National Advisory Council on Human Genome Research. . 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.
  • Program balance, including balance with respect to scientific topics within the CEGS program.
  • Expansion of the community of genomic scientists to include new investigators and experienced investigators new to the field, and outreach to investigators from demographic groups that are generally under-represented in genomic science.
  • Geographic and institutional diversity, including whether the application is from an institution that has previously not had a CEGS award, with the aim of encouraging CEGS from many different institutions.

3. Anticipated Announcement and Award Dates

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

Section VI. Award Administration Information

1. Award Notices

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

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

Recipients must comply with any funding restrictions described in Section IV.6. 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 and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient 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).

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identify, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html

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.

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.

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 and 2 CFR Part 200.206 “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

3. Reporting

When multiple years are involved, recipients 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. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All recipients 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 the threshold.  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 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, 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 and 2 CFR Part 200 – Award Term and Condition for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

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

Application Submission Contacts

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: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-637-3015

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Scientific/Research Contact(s)

Stephanie A. Morris, Ph.D.
National Human Genome Research Institute (NHGRI)
Telephone: 301-435-5738
Email: morriss2@mail.nih.gov

Tara Dutka, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-451-3074
Email: Tara.dutka@nih.gov

Tara Dutka, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-451-3074
Email: tara.dutka@nih.gov
Peer Review Contact(s)

Dr. Keith Mckenney

National Human Genome Research Institute (NHGRI)
Telephone: 301-401-8823
Email: mckenneyk@mail.nih.gov

Financial/Grants Management Contact(s)

Annelise Galczynski

National Human Genome Research Institute (NHGRI)
Telephone: 301-443-4935
Emai: anneliese.galczynski@nih.gov

Terri Jarosik
National Institute of Mental Health (NIMH)
Telephone: 301-443-3858
Email: tjarosik@mail.nih.gov

Heather Weiss
National Institute of Mental Health (NIMH)
Telephone: 301-443-4415
Email: weissh@mail.nih.gov

Section VIII. Other Information

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

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.

NIH Office of Extramural Research Logo
Department of Health and Human Services (HHS) - Home Page
Department of Health
and Human Services (HHS)
USA.gov - Government Made Easy
NIH... Turning Discovery Into Health®


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.