Part 1. Overview Information

Key Dates

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.

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 NOFO or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the Application Guide and the NOFO) 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 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Background

Over the last 32 years, the NHGRI ELSI Research Program has funded research addressing a broad array of advances in genomic science and medicine.  Research supported by the program is carried out using a wide variety of methods and approaches, resulting in publications in more than 400 different journals spanning dozens of disciplines and topics. There is no single society or conference that defines the field, nor a single research search engine that covers its scholarship. The heterogeneity of the field is considered a key strength of the program; however, it also poses several challenges. For example, researchers, educators, health practitioners and policy makers often find it difficult to locate, synthesize and act upon ELSI research. Investigators may duplicate efforts or miss opportunities to build on prior work. The effectiveness of regulations, policies and practice guidelines related to genomics might be improved if there was greater awareness of the evidence-base provided by ELSI research. As the exploration, translation and use of genomics grows across biomedicine and outside of the health sector, those not actively engaged with the ELSI research community may be less familiar with the range of implications tied to this growth. Ensuring ELSI research is easily found, clearly summarized, and broadly accessible will help mitigate harm and maximize benefit as genomic knowledge, data and technologies grow.

In 2019 CERA was funded under RFA-HG-18-008 in order to 1) provide ELSI researchers with an established platform to share their research tools and products related to genomics; 2) serve as a resource that curates and synthesizes ELSI research on key topics in the field, highlights new findings and provides access to these works; and 3) convene ELSI researchers for both small and large scale transdisciplinary projects and meetings to help address the ever emerging ELSI issues that arise with the use of genomics. In November 2020, CERA launched ELSIhub as an online platform that includes searchable databases of publications, research tools, live and archived seminars, and other resources; curated literature collections on foundational and emerging topics; and trainee resources and networking opportunities.

Research Scope and Objectives

This funding opportunity proposes to build upon the key functions of CERA while also developing innovative content and expanding its reach. CERA will focus on the ELSI of genetics and genomics, which is the established focus of the NHGRI ELSI Research Program. All CERA activities and resources should reflect the interests, needs, and perspectives of the broader ELSI research community. For the purposes of this NOFO, the ELSI research community refers to researchers and trainees who receive funding from the NHGRI ELSI Research Program and individuals who conduct research investigating ELSI research questions. The broader ELSI research community includes individuals who conduct, utilize, or have interest in ELSI scholarship and other stakeholders, as appropriate. CERA will work to achieve three primary goals: 1) provide ELSI researchers with an online platform to share ELSI research products; 2) curate and synthesize ELSI research; and 3) facilitate new research collaborations and uptake of ELSI research. CERA will increase the availability and visibility of ELSI products and resources and serve as a source of expertise for the larger research and policy communities.

CERA will develop and maintain an online platform for researchers to share and search for ELSI research products. This platform will collect, receive, index, store, and make publicly available ELSI research products in a structured and searchable central database. For the purposes of this funding announcement, ELSI research products include but are not limited to data collection instruments, analytical techniques, research publications and findings, and other study products. ELSI research products shared by CERA do not include data and metadata collected in ELSI research (see below).  CERA will collaborate with the NHGRI to identify, prioritize, and incentivize the sharing of a broad array of ELSI research products.

The platform should include an intuitive interface which allows researchers with different academic or professional backgrounds and levels of expertise to easily contribute, navigate, and locate CERA resources. To avoid duplicating resource-intensive tasks underway elsewhere, the CERA platform will not serve as a repository for ELSI research data and will not be responsible for data curation, storage, management or sharing. Rather, as NIH funded projects begin to comply with the NIH Data Management and Sharing Policy that went into effect on January 25, 2023, the CERA platform will establish an online resource that collects, organizes and provides links to ELSI research data, metadata and the corresponding ELSI research products and presents this information in a searchable and easily accessible format on the developed platform.

CERA will curate and synthesize ELSI research.  It will plan and facilitate development of broad overviews of ELSI scholarship through meta-analysis, literature review and other methods. CERA will also develop curated resources on foundational and emerging topics. The processes used to select topics, curate information, and develop and disseminate resources will be fully transparent and allow for input and participation from the broader ELSI research community.  To accomplish these curation and synthesis activities, CERA will consult members of the broader ELSI research community and others with relevant expertise as part of this curation process.

CERA will facilitate new collaborations and increase uptake of ELSI research. This goal will be accomplished by convening ELSI researchers and other stakeholders and conducting outreach, dissemination, and translation activities. To increase rigor, reach and effectiveness, collaborations should promote inclusion of researchers and other stakeholders from a broad range of disciplines, professional backgrounds, and lived experiences, including those who are underrepresented in genetic and genomic research. Examples of activities to spur new collaborations could include facilitating special journal issues, holding meetings that generate new scholarship or policy analysis, developing a webinar series, supporting community-based or stakeholder-based discussions, or organizing ELSI panels and presentations at a wide range of conferences.  These activities should serve to connect ELSI researchers and their findings to a wide range of stakeholders who might find them useful.

CERA will develop innovative strategies to: (a) encourage and incentivize broad stakeholder participation in CERA’s work; (b) facilitate engagement and collaboration among interested researchers examining ELSI, including those who self-identify as ELSI researchers and those who do not; (c) ensure that a wide variety of stakeholders directly and indirectly involved in genomics are aware of ELSI research that can be utilized in their work; and (d) inform those interested in ELSI research about the expanding genomic landscape. When developing these strategies, CERA should consider different modes of ELSI research including both embedded and independent ELSI research projects. In addition to ELSI researchers, CERA should also consider the needs and interests of researchers in the fields of genomic science and genomic medicine who may be interested in becoming more engaged in ELSI research. Such researchers may seek general information or guidance about a particular ELSI topic related to their research or may want to collaborate with ELSI researchers to address challenges in their work. CERA should keep apace of emerging areas both in ELSI research and in genomics more broadly. Strategies should address different career stages, including students and trainees interested in ELSI research and trainees whose work in genetics or genomics might involve ELSI considerations.

The ELSI Research Program supports both investigator-initiated and program-initiated activities.  NHGRI ELSI funding opportunities include R01, R21 and R03 grant program announcements and training of new ELSI scholars through several mechanisms. The ELSI program also supports research embedded in larger clinical sequencing programs and in basic genomic sciences programs in collaboration with the NHGRI Division of Genomic Medicine and the Division of Genome Sciences. CERA will be expected to collaborate effectively with  ELSI and genomic researchers and may work with additional NHGRI programs as appropriate. CERA will increase the availability and visibility of ELSI research products and provide expertise to NHGRI programs, other relevant NIH programs, and other US-based and international genomics efforts.

CERA will ensure that the platform, resources, and events are made accessible to a wide variety of potential users. CERA should take a proactive approach in designing a resource that may be utilized by individuals with differing needs or who may require various accommodations or features in order to fully utilize and participate in CERA. In developing this approach, CERA should consider compatibility with assistive technologies. CERA should develop strategies to enable broad participation in any proposed events, including virtual and in-person live events as well as access to archived, recorded events, as appropriate. CERA will identify and be transparent about the accessibility standards used in their project and how they will evaluate and adapt their proposed strategy throughout the course of the project period. Finally, CERA should serves as an exemplar and potential resource on accessibility practices for the broader ELSI research community.

To build and improve upon current efforts, CERA will ensure that it reflects the interests, needs and perspectives of its intended users, to include individuals from a broad range of disciplines, professional backgrounds, and lived experiences. CERA will conduct needs assessments, program evaluation, and usability testing across relevant activities and resources with current and potential users. Needs assessment will prospectively identify needs and interests of the broader ELSI research community and establish a baseline to support program evaluation. Program evaluation will examine the quality of CERA resources and activities throughout the course of the award. Usability testing will assess user experiences with the online platform and other web or technology-based resources or activities. Usability testing will be conducted throughout the course of the award, especially when new capabilities or enhancements are launched. CERA’s approach to needs assessment, program evaluation, and usability testing should be commensurate with the scope and complexity of proposed activities and resources. Plans should include specific performance metrics and benchmarks, strategies to reach those benchmarks, and approaches to track and assess progress.

CERA will establish a clear and comprehensive management plan which covers all aspects of its work. The plan will include clearly defined objectives, milestones, and timelines for each of CERA’s three primary goals. An External Scientific Panel (ESP) will be formed in conjunction with NHGRI at the beginning of the project period to provide expert recommendations on CERA activities and priories throughout the course of the project.

While the NIH Data Management and Sharing (DMS) Policy does not apply to development of infrastructure resources (e.g., the establishment of a platform), other components of this award may facilitate or otherwise support research and the generation of scientific data. Applicants must include a Data Management and Sharing (DMS) Plan addressing management and sharing of scientific data, including those that may be generated by subawards, or research collaborations facilitated or spurred by the CERA. For the platform itself, the infrastructure developed should comport with the desirable characteristics for repositories, many of which are also applicable to knowledgebases (see “Selecting a Repository for Data Resulting from NIH-Supported Research”).

All resources developed by CERA will be designed as non-proprietary and open source employing user interfaces that will allow the upload and download of resources. In addition, all resources developed by CERA will be portable and easily transferred to other institutions as needed.

All applicants are strongly encouraged to contact NHGRI program staff to discuss the alignment of their proposed project with the primary goals of this NOFO.

Plan for Enhancing Diverse Perspectives (PEDP)

• This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP) as described in NOT-MH-21-310, submitted as Other Project Information as an attachment (see Section IV).
• Applicants are strongly encouraged to read the NOFO instructions carefully and view the available PEDP guidance material. The PEDP will be assessed as part of the scientific and technical peer review evaluation, as well as considered among programmatic matters with respect to funding decisions.

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

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

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.

• 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. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their 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.

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 their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women 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 NOFO 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).

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 NOFO. 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 notice of funding opportunity 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:

Nicole Lockhart, Ph.D.
Telephone: 301-480-2493
Email:lockhani@mail.nih.gov

Page Limitations

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 NOFO, the Research Strategy section is limited to 30 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 NOFO.

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.

Other Attachments:

Plan for Enhancing Diverse Perspectives (PEDP)

In an "Other Attachment" entitled "Plan for Enhancing Diverse Perspectives," all applicants must include a summary of strategies to advance the scientific and technical merit of the proposed project through expanded inclusivity. The PEDP should provide a holistic and integrated view of how enhancing diverse perspectives is viewed and supported throughout the application and can incorporate elements with relevance to any review criteria (significance, investigator(s), innovation, approach, and environment) as appropriate. Where possible, applicant(s) should align their description with these required elements within the research strategy section. The PEDP will vary depending on the scientific aims, expertise required, the environment and performance site(s), as well as how the project aims are structured. The PEDP may be no more than 1-page in length and should include a timeline and milestones for relevant components that will be considered as part of the review. Examples of items that advance inclusivity in research and may be part of the PEDP can include, but are not limited to:

• Discussion of engagement with different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, community-based).
• Description of any planned partnerships that may enhance geographic and regional diversity.
• Plan to enhance recruiting of women and individuals from groups traditionally under-represented in the biomedical, behavioral, and clinical research workforce.
• Proposed monitoring activities to identify and measure PEDP progress benchmarks.
• Plan to utilize the project infrastructure (i.e., research and structure) to support career-enhancing research opportunities for diverse junior, early- and mid-career researchers.
• Description of any training and/or mentoring opportunities available to encourage participation of students, postdoctoral researchers and co-investigators from diverse backgrounds.
• Plan to develop transdisciplinary collaboration(s) that require unique expertise and/or solicit diverse perspectives to address research question(s).
• Publication plan that enumerates planned manuscripts and proposed lead authorship.
• Outreach and planned engagement activities to enhance recruitment of individuals from diverse groups as research participants including those from under-represented backgrounds.

For further information on the Plan for Enhancing Diverse Perspectives (PEDP), please see https://braininitiative.nih.gov/about/plan-enhancing-diverse-perspectives-pedp.

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.

Effective management will require a significant commitment by the Program Director(s)/Principal Investigator(s). For an application proposing a single PD/PI, that PD/PI is expected to make a minimum commitment of 4 calendar months.  If multiple PDs/PIs are proposed, the combined time commitment of all PIs must total to at least 4 calendar months and any individual serving as a PD/PI must commit at least 1 calendar month of their time.

Budgets should include support for a dedicated Project Manager who will devote a minimum of 4 calendar months to oversee the day-to-day activities of the project, coordinate across project sites, if applicable, and be responsible for promptly providing requested reporting information to NHGRI program staff.

Budgets should include, but are not limited to, support for 2-3 group members to attend relevant national meetings as part of their outreach and dissemination activities. Budgets should also include attendance for 3-5 members at the biennial ELSI Congress to be held in 2024, 2026 and 2028 which will be planned and organized under a separate award but coordinated with CERA activities.

Budgets should include support for infrastructure, resources, and personnel to ensure broad accessibility to CERA. Budgets should also include support for proposed needs assessments, program evaluation, and usability testing of CERA resources and activities.   

Budgets should include any funds required to support sharing of scientific data under this NOFO. NIH provides guidance on allowable costs for data management and sharing here.

Applicants need to demonstrate an understanding of costs and how to track them. Costs should include infrastructure and all personnel. Applicants should describe how these costs will change over the course of the project.  All cost analyses should include an explicit item for Direct Costs and then be presented in terms of Total Costs.

PEDP implementation costs:

Applicants may include allowable costs associated with PEDP implementation (as outlined in the Grants Policy Statement section 7: https://grants.nih.gov/grants/policy/nihgps/html5/section_7/7.1_general.htm).

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:

1) Platform to share ELSI research products related to genomics

Applicants should describe their overall strategy and vision for an online platform to share and search for ELSI research products, including:

• Plan to develop an online platform to collect, receive, index, store, and make publicly available ELSI research products, including but not limited to data collection instruments, analytical techniques, research publications and findings, and other study products; and excluding data and metadata collected in ELSI research
• Plans for how to identify, collect, receive, index, store, and make publicly available ELSI research products in a structured and searchable central database.
• Innovative strategies to encourage and incentivize past, current and future ELSI investigators to contribute ELSI research products to CERA, such as microattribution, usage or download statistics for contributors, provision of small “seed grants” to contributors, etc.
• Strategies to track and maintain a structured and searchable central database of ELSI scholarship and its products
• Strategies to ensure an intuitive interface which allows researchers with different backgrounds and levels of expertise to easily contribute, navigate, and locate CERA resources
• Detailed plan for collecting, organizing, and providing links to ELSI research data, metadata, and the corresponding ELSI research products and presenting this information in a searchable and easily accessible format
• A description of how the platform will meet the desirable characteristics of a data repository, as applicable.

2) Curating and synthesizing ELSI research

Applicants should describe their overall strategy for curating and synthesizing key topics across the range of ELSI research, including:

• Plan to facilitate broad overviews of ELSI scholarship through meta-analysis, literature review and other methods
• Plan for identifying foundational and emerging ELSI research topics for CERA collection, curation, and synthesis
• Detailed plan to ensure processes used to select topics, curate, and synthesize information, develop resources, and disseminate products will be fully transparent and allow for input and participation from the broader ELSI research community
• Strategies for ensuring curation and synthesis activities include researchers and other stakeholders from a broad range of disciplines, professional backgrounds, and lived experiences
• Plan for the communication and dissemination of resources and products developed through these activities

3) Facilitate new research collaborations and increase uptake of ELSI research

Applicants should describe innovative strategies to facilitate research collaborations and help ensure ELSI research products and findings are accessible and highly utilized, including:

• Strategies to encourage collaborations that include researchers and other stakeholders from a broad range of disciplines, professional backgrounds, and lived experiences, including those who are underrepresented in genetic and genomic research
• Strategies to convene ELSI researchers and other stakeholders through activities including, but not limited to meetings of various sizes and formats, facilitating special journal issues, developing webinar series, supporting community-based or stakeholder-based discussions, or organizing ELSI panels and presentations at a wide range of conferences
• Strategies to encourage and incentivize broad stakeholder participation in CERA
• Plans to facilitate engagement and collaboration among those who identify as ELSI researchers and those who do not, utilizing a variety of outreach, dissemination, and translation strategies
• Plans to ensure that a wide variety of stakeholders directly and indirectly involved in genomics are aware of ELSI research that can be utilized in their work
• Plans to keep apace with, disseminate information about, and facilitate engagement around emerging areas in ELSI research and in genomics more broadly
• Plans and strategies to train potential users on how to access and utilize CERA resources and provide ongoing user support
• Strategies for outreach and dissemination across different career stages, including students and trainees interested in ELSI research and trainees whose work in genetics or genomics might involve ELSI considerations
• Approaches for effective collaboration with  ELSI and genomic researchers supported by NHGRI, other relevant NIH programs, and other US-based and international genomics efforts, as appropriate and relevant to the mission of CERA

4) Accessibility

Applicants should describe how they will ensure that the platform, resources, and events created by CERA are accessible to a wide variety of potential users, including:

• A detailed and proactive plan to enable access by individuals with differing needs or who may require various accommodations or features in order to fully utilize and participate in CERA. This plan should include compatibility with assistive technologies.
• Strategies to enable broad participation in any proposed events, including virtual and in-person live events as well as access to archived, recorded events, as appropriate
• Applicants should describe what standards will be used to determine the degree of accessibility and how they will evaluate and adapt their proposed strategy throughout the course of the project period
• A clear strategy for how CERA will be transparent about accessibility standards and serve as a potential resource on accessibility practices for the broader ELSI research community

5) Needs Assessment, Usability Testing, and Evaluation

Applicants should describe how they will ensure that the CERA reflects the interests, needs and perspectives of its intended users, including individuals from a broad range of disciplines, professional backgrounds, and lived experiences:

• Detailed plans for needs assessments to identify needs and interests of the broader ELSI research community and establish a baseline to support program evaluation. Plans for needs assessments should begin at the start of the first year, be prospective in focus, and be conducted at least annually.
• Detailed plans for program evaluation to examine the quality of CERA resources and activities. Program evaluations should be retrospective in focus and be conducted throughout the course of the award.
• Detailed plans for usability testing to assess user experiences with the online platform and other web or technology-based resources or activities. Plans should describe how usability testing will be conducted throughout the course of the award, including when new capabilities or enhancements are launched.
• CERA’s approach to needs assessment, program evaluation, and usability testing should be commensurate with the scope and complexity of proposed activities and resources.
• All plans related to needs assessment, program evaluation and usability testing should include specific performance metrics and benchmarks, strategies to reach those benchmarks, and approaches to track and assess progress.
• All plans related to needs assessment, program evaluation and usability testing should outline strategies to adapt and respond to needs and interests identified by intended users throughout the course of the project

6) Management Plan

• The management plan should describe how the PD(s)/PI(s) will manage the proposed project, who will oversee the day-to-day activities (i.e., a project manager if not a PD/PI), and how the management structure will support achievement of the proposed goals and milestones.
• Useful elements of this description include the organization of the proposed project; its management structure; key personnel; section leaders and reporting relationships; and the proposed role of the External Scientific Panel. 
• The External Scientific Panel will be assembled and given its charge in collaboration with NHGRI staff, therefore applicants should not contact potential advisors prior to the review of the application, nor should potential advisors be named in the application or provide letters of support.
• Recruitment and training of personnel may also be discussed. The plan should also describe how the various components of the proposed effort will be integrated, and how collaborations or subcontracts, if proposed, will be managed.

7) Non-proprietary

• Describe a detailed plan for ensuring all resources and tools developed by CERA are designed as non-proprietary and open source employing user interfaces that allow the upload and download of resources
• Describe a detailed plan for ensuring all resources and tools developed by the CERA are portable and easily transferred to other institutions as needed.

8) Evidence of Successful Past Performance

• Applicants should provide evidence of research productivity as part of a consortium or other collaborative research network.  
• Applicants should demonstrate the capacity to scale activities and maintain flexibility as CERA evolves.

9) Information Technology (IT)

• Applicants should discuss all pertinent informatics issues involved in providing the IT infrastructure/system administration for the proposed project.

10) Timeline, milestones, and goals

• Applications should establish a timeline and define a clear set of objectives for CERA for each of the 3 primary goals of CERA. Applications should identify annual milestones and specific metrics that will be used to assess progress and effectiveness in the achievement of established goals and objectives.  
• Examples of milestones include but are not limited to 1) implementation of the first needs assessment; 2) public availability and functionality of the CERA platform; 3) completion of a curated resource with collaborators underrepresented in research.
• Examples of metrics include but are not limited to 1) rate of growth in the number of ELSI research products available through CERA; 2) number of activities developed or modified in response to needs assessment results; 3) number of outreach activities and their effectiveness in facilitating new collaborations. 
• Applications should critically review and update milestones and metrics at least annually. Milestones and metrics should be commensurate with the scope and complexity of the project and driven by the timing and progress in achieving proposed resources and activities.
• Milestones or metrics may be revised at the time of the award as described in the terms and conditions of a Cooperative Agreement in section VI.2

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:

Applicants should include a detailed plan on how the structure of the platform, its specific elements and content, the backend infrastructure (e.g., the database schema, the software interfaces, the associated documentation, etc.) and any related data analysis tools, including both executables and source code, will be rendered easily transferable to third parties or other institutions at the completion of the grant period. Software should be freely available to biomedical researchers and educators in the non-profit sector, such as education institutions, research institutions, and government laboratories. For a list of frequently asked questions about Best Practices for Sharing Research Software, see https://datascience.nih.gov/tools-and-analytics/best-practices-for-sharing-research-software-faq.

Consistent with 45 C.F.R. 75.322, the recipient  will own the data and software developed under this award and be able to continue to use these data and software upon expiration or termination of the award. NIH will have unrestricted access and use of the data and software, including the right to transfer them to other resource projects for their use, distribution, and integration with other data.

After initial review, NHGRI program staff will conduct an additional administrative review of the plan for resource sharing and may negotiate modifications of this plan with the prospective recipient . The final negotiated version of this plan will become a term and condition of the award

Other Plan(s): Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

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

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

The following modifications also apply:

While the NIH Data Management and Sharing (DMS) Policy does not apply to development of infrastructure resources (e.g., the establishment of a platform), other components of this award may facilitate or otherwise support research and the generation of scientific data. Therefore, please follow the NIH guidance on writing a Data Management and Sharing (DMS) Plan here, and ensure the Plan is in alignment with NHGRI’s data sharing expectations, which are summarized at genome.gov/data-sharing.

DMS Plans should address management and sharing of scientific data, including those that may be generated by subawards or research collaborations facilitated or spurred by the CERA. Applicants should ensure that data and other information produced or distributed by the resource follow the FAIR (Findable, Accessible, Interoperable, and Reusable) Principles.

Scientific data that need to be managed and shared per the DMS Policy may change over the course the project. If DMS Plan revisions are necessary, Plans should be updated during regular reporting intervals or sooner, with appropriate required approvals by the funding IC of any updates or revisions to the DMS Plan.

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 field of 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 NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier 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 and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

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

Applications must include annual milestones. Applications that fail to include annual milestones will be considered incomplete and will be withdrawn. Applications must include a PEDP submitted as Other Project Information as an attachment. Applications that fail to include a PEDP will be considered incomplete and will be withdrawn before review.

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.

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.

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.

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.

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.

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 NOFO.

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 submitted in response to this NOFO. 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.

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 NOFO 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.

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that 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.

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:

• Federal wide Research Terms and Conditions
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

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 will be required to complete an HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a term and condition of receiving the grant, to administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity. 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 NOFO.

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.

• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including providing program access, reasonable modifications, and to provide effective communication, see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html.

• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.

• For guidance on administering programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/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.

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.”

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, 2 CFR Part 200 and other HHS, PHS, and NIH grant administration policies. 

The administrative and funding instrument used for this award will be managed as a cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with recipient. Specific tasks and activities may be shared among the recipients and the NHGRI staff as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

• Determining research approaches, designing protocols, setting project milestones and timelines, and conducting research.
• Ensuring that the  software, resources, materials, etc. produced as part of this project are released appropriately according to the Resource Sharing Plan.
• Ensuring that the data produced as part of this project are released appropriately according to the Data Management and Sharing Plan.
• Preparing abstracts, presentations and publications in a timely manner.
• Adhering to policies regarding sharing of genomic and other types of data, data access, and standardized formats; timely publication; and intellectual property established by the NIH, NHGRI, and the Steering Committee (SC).
• Not disclosing confidential information.
• Interacting with other relevant NHGRI and NIH activities, as needed, to promote synergy and consistency among similar or related projects.
• Submitting periodic progress reports in a standard format, including metrics of the use and impact on the community, as agreed on with the NHGRI Project Scientist/Scientific Officer (PS/SO).
• Providing reports, summary statistics, and data, as appropriate, in a timely fashion as agreed upon by the PS/SO.
• Sharing research resources, tools, data and information of interest with the broader ELSI and genomic research communities consistent with achieving the goals of the project.
• Attending and participating in SC, ESP, and other working group meetings and accepting and implementing decisions made by the SC or recommended by the ESP.
• Providing annual and overall project period milestones, to the NHGRI as requested (usually at the outset of the award and annually thereafter, but also at other times as requested by NHGRI program staff).
• Recipients(s) will retain custody of and have primary rights to the data and software developed under these awards, subject to Government policies regarding rights of access consistent with current DHHS, PHS, and NIH policies 
• Ownership of the data and software hosted, uploaded, or generated on CERA’s platform remains with the data and software providers. The recipients have no possessor rights of the data, software, and workflows provided or generated by CERA platform users, who will retain ownership and control of their resources.
• A fundamental objective of this cooperative agreement is to ensure that the valuable data, software, workflow resources and other platform content provided by CERA remain available without interruption to the research community if the recipient withdraws, or otherwise can no longer manage the resource, or if the award is terminated by the NIH. At the end of the award, or if a new recipient has been selected prior to the end of the award, the recipient will work with NHGRI staff and the new award recipient to transition the data and software to the new service, or to the Government.
• Software, tools, workflows, and other technologies built under this NOFO should be made available with an open-source license. The use of proprietary software, tools, and workflows is acceptable, but should be compatible, and not in conflict, with the broad resource dissemination requirements of this NOFO.

NHGRI staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

The Project Scientist/Scientific Officer (PS/SO) at NHGRI is a dual role held by a NHGRI Program Director. In the Project Scientist role, the Program Director will have substantial scientific and programmatic involvement during the conduct of this activity through technical assistance, advice, and coordination. In the Scientific Officer role, the Program Director will be responsible for the normal scientific and programmatic stewardship of the award and manages concerns about bias as it affects the project. The role of NHGRI PS/SO will be to facilitate and not to direct the activities. The PS/SO will be named in the Notice of Award.

The PS/SO will have the following substantial involvement:

• Serving as a liaison, helping to coordinate activities among and for the recipients, including acting as a liaison to the NHGRI and as an information resource for the recipients about genome research activities. The PS/SO will also coordinate the efforts of the recipient (s) with other groups conducting similar studies.
• Reporting periodically on the progress of the recipients  to the NHGRI Director and to the National Advisory Council for Human Genome Research.
• Assisting recipient(s) in the development, if needed, of policies for dealing with situations that require coordinated action.
• Providing advice on the management and technical performance of the award.
• Assisting in promoting the availability of the data and related resources developed in the course of the award to the scientific community.
• Being responsible for the normal scientific and programmatic stewardship of the award, including assessments of how well the recipient has met any milestones required for each year of funding. 
• Curtailing, withholding or reducing support for any recipient that fails to make satisfactory progress toward the work scope that NHGRI approved, has ethical or conflict of interest issues, or fails to comply with the Terms and Conditions of Award.
• Involving NIH or NHGRI staff who may assist the recipient(s) as designated by the PS/SO.
• Where warranted and consistent with authorship and conflict of interest requirements of journals in which the Consortium/Network decides to publish, co-authoring manuscripts through their role in scientific program management.

External Scientific Panel (ESP): The NHGRI PS/SO may engage external scientists with relevant scientific and consortium experience, who are not funded as part of the project and who agree to a confidentiality policy, to provide input and advice to the NHGRI PS/SO about the project. The PS/SO will appoint scientists to the ESP and will determine the durations of service.  Activities of the ESP could include:

• Participating, as appropriate, in recipient  meetings, Steering Committees calls, and the annual recipients ’ meetings; a subset of ESP members may also meet remotely at other times during the project period, as needed.
• Reviewing and evaluating the progress of recipients  (individually or as a group) in achieving the goals of the project.
• Recommending changes in priorities based on scientific advances within and outside the project;
• Providing individual recommendations regarding any changes in the project or grant(s) as necessary.

The PS/SO will use these recommendations to make project changes, as appropriate.

Areas of Joint Responsibility:

If there are multiple awards working toward a common goal, close interaction between the participating recipient (s) and the PS/SO will be required, to manage, assess, and implement the award(s). This is accomplished by:

• Meeting monthly by conference call to share information on data resources, methodologies, analytical tools, data analyses, preliminary results, etc.
• Establishing best practices for data integration and collaborative analyses as appropriate.
• Setting research priorities, deciding optimal research approaches and protocol designs, and contributing to the adjustment of research protocols or approaches as warranted.
• Generating responses to ESP recommendations.

The PS/SO will assist and facilitate the group process and not direct it.

• In addition to the PD(s)/PI(s), key co-investigators and pre- and postdoctoral trainees, especially those who are members of under-represented minority groups or those from different but related disciplines, are eligible to attend these meetings.
• Steering Committee (SC): The SC will be the main governing body of the Consortium. The purpose of the SC will be to make recommendations consistent with achieving the project goals, develop policies to build synergy and improve communication and collaboration between the projects, and to provide a forum for discussing progress, challenges and opportunities. Each representative will have one vote. The PS/SO will be a non-voting member.
• The SC will develop its own operating procedures.
• The SC may establish subcommittees to oversee the development and implementation of CERA policies. Subcommittees may be either permanent or time limited, may include additional experts, depending on the needs of the research.
• The PD(s)/PI(s) will be expected to play an active role in these working groups, as appropriate.
• It is expected that most of the decisions on the activities of the SC will be reached by consensus. If a vote is needed, at least 60% of the voting members must vote in favor of the proposal.
• NIH staff will review and approve policies developed by the SC.
• Recipients will be required to accept and implement policies approved by the SC.

Dispute Resolution

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NHGRI may be addressed by convening a Dispute Resolution Panel.  It will be composed of three members: a designee of the SC chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of disagreement for one award, the first member may be chosen by that recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Data Management and Sharing

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. 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.

Recipients  will provide updates at least annually on implementation of the PEDP

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 NOFOs 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.

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: https://www.era.nih.gov/need-help (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: 301-480-7075

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

Nicole Lockhart, Ph.D.
National Human Genome Research Institute (NHGRI)
Telephone: 301-480-2493
Email: lockhani@mail.nih.gov

Lydia Mann Kline, MA
NIH Office of Science Policy
Email: lydia.kline@nih.gov

Rudy Pozzatti, Ph.D.
National Human Genome Research Institute (NHGRI)
Telephone: 301-219-6235
Email: pozzattr@exchange.nih.gov

Maricela Trujillo
National Human Genome Research Institute (NHGRI)
Telephone: 301-480-7716
Email: maricela.trujillo@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.

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.