It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

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

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to establish a National Human Genome Research Institute (NHGRI) Technology Development Coordinating Center. The Coordinating Center will be responsible for enhancing integration between components of the NHGRI Genome Technology program by facilitating opportunities for collaborations and leading efforts to promote standards in genomic technologies. The Coordinating Center will also disseminate program advances, develop resources and outreach strategies for engaging the broader biomedical research community, and manage an Opportunity Funds program to rapidly fund and support promising small-scale work that advances development of innovative genomic technologies. In support of these activities, the Coordinating Center will develop an infrastructure for coordination of technology development funded by NHGRI that will include significant administrative, logistical, and technical management. The Coordinating Center will be expected to work collaboratively with NHGRI-funded technology development grantees and NHGRI staff, as well as interact with other investigators and programs with goals that align with the NHGRI Genome Technology program.

Background

Advances in genomic technologies and methods have facilitated research that is producing significant insights into biology and disease. To further these advances, NHGRI supports the Genome Technology program, which aims to accelerate innovation, development, and early dissemination of genomic technologies. The development of completely novel approaches and the refinement of current technologies to achieve orders-of-magnitude improvements are foundational goals of the program. With these goals in mind, the Genome Technology program consists of a growing set of interrelated efforts that enable novel and refined technologies to proceed through discovery and development, towards commercialization and clinical utilization. These include:

• Novel Nucleic Acid Sequencing Technology Development. The goal of this initiative is to develop new technologies and improve the quality and efficiency of DNA sequencing and direct RNA sequencing through the support of approaches and instrumentation that will significantly advance the field of genomics. These efforts are funded through RFA-HG-18-001, RFA-HG-18-002, and RFA-HG-18-003.
• Novel Genomic Technology Development. This initiative seeks to catalyze the development and advancement of new technologies that can comprehensively analyze genomic features such as methods to evaluate gene regulation and nuclear organization, and the dynamics of genomic features in single and mixed populations of cells (excluding nucleic acid sequencing technologies). These efforts are funded through PAR-18-777, PAR-18-778, and PAR-18-779.
• Novel Synthetic Nucleic Acid Technology Development. This initiative is focused on supporting the advancement of novel technologies and methods to inexpensively and accurately synthesize specified sequences of nucleic acids and synthetic constructs at the scale needed for genomics-based research. These efforts are funded through RFA-HG-20-014, RFA-HG-20-015, and RFA-HG-20-016.

Each of these initiatives supports traditional research projects (R01 and R21) and small business awards (R43 and R44). NHGRI also supports investigator-initiated technology development projects that come in through NIH parent announcements as well as through research supported under the Centers of Excellence in Genomic Science (CEGS) program. Opportunities for coordinated interactions among the diverse community of researchers that contribute to NHGRI technology development are largely limited to activities that occur during yearly grantee meetings. Further, technologies supported under the current NHGRI Genome Technology program are being newly developed and continuously improved in response to scientific advances; however, they are not always widely promoted as resources that are disseminated and used by the broader biomedical research community. With establishment of the NHGRI Technology Development Coordinating Center, an infrastructure will be developed to address the need for closer interactions between these efforts. This will enable opportunities for collaboration among grantees, accelerated technology innovation, and improved dissemination of program advances and resources to the broader biomedical research community.

Applicants to this FOA are encouraged to read the funding opportunities mentioned above as well as visit the websites for the Genome Technology and CEGS programs for more information about NHGRI funded activities in this area. For the purpose of this FOA, "the Genome Technology program" refers to activities for the FOAs stated above. The Center's responsibilities will primarily be for the Genome Technology program unless stated otherwise.

Research Objectives

NHGRI seeks to fund a Coordinating Center that will expand the support and coordination of technology development efforts funded by NHGRI. The goal is to accelerate technology development and progress in the field of genomics. Varied expertise is required, especially prior experience in coordinating large and complex multidisciplinary collaborative research efforts and appropriate expertise in the scientific areas covered by the Genome Technology program. The Coordinating Center’s objectives are outlined as follows:

Facilitate collaborations and promote standards in genomic technologies.

• The Coordinating Center will organize two annual 2-3-day investigator meetings per year - one for NHGRI's Genome Technology program and one for the NHGRI CEGS program. Attendance of these meetings by the respective program grantees is required. Annual meetings for both programs are expected to serve as venues to facilitate sharing of research findings, promote the exchange of ideas, and enable discussion of opportunities, challenges, and emerging needs in genome technology development.
• The Coordinating Center will lead efforts to coordinate, develop, and promote the uptake of standards for technologies supported by the Genome Technology program. This will involve forming working groups to define metrics and develop benchmarking approaches. Groups will be composed of Genome Technology program grantees and will involve discussion of existing standards and approaches, current methods used by grantees to benchmark their technologies, and identification of needs in standards development such as development of genomic technology reference standards for which currently none exist. As part of these efforts, the Coordinating Center will be expected to work with working group members to develop and organize recommendations that can be shared with the broader biomedical research community.
• The Coordinating Center will also be responsible for mediating outreach to programs within and outside of NIH that support standards development relevant to the interests of the Genome Technology program. The focus should be on developing interactions to facilitate sharing of lessons learned, best practices, and existing standards that can be leveraged to enhance development and use of standards for genomic technologies.
• As needed, the Coordinating Center will establish working groups around other topics of great interest to the field of genomic technology development identified by program grantees in consultation with NHGRI staff.

Disseminate advances and develop outreach and community engagement approaches.

• The Coordinating Center will be responsible for establishing a publicly accessible website for the Genome Technology program to share information such as supported technologies, resources, and program advances.
• The Coordinating Center will also be responsible for development of technology transfer informational resources. This will be relevant to all with interests in commercializing genomic technologies and clinical utilization, especially for researchers at institutions with limited internal resources or experience in supporting the technology transfer process. The goal of these efforts is to provide resources that range from information about the fundamentals of intellectual property protections to identifying relevant applications and strategies for technology dissemination and adoption.
• In line with engagement of the community, the Coordinating Center will develop outreach approaches and educational materials to engage program grantees and the broader biomedical research community. This may include activities such as webinars and presentations on technologies that range from overviews of basic technology concepts to new innovations in genome-based technologies. Materials developed should be wide-ranging to target a variety of researchers from trainees to established investigators.

Provide opportunity funds for promising small-scale work.

The Coordinating Center will manage and administer an Opportunity Funds program to support early and innovative pilot projects in priority areas aligned with the goals of the Genome Technology program. Funds for this program will be provided as part of the Coordinating Center in years 2-4 and disbursed to successful applicants as approved by NHGRI. The Coordinating Center will manage solicitation of project proposals, the review process, selection of projects recommended for funding, and disbursement of funds through subawards issued to individual investigators. The Coordinating Center will also be responsible for regularly monitoring and reporting on awardee progress, expenditures, and management of the Opportunity Funds program to NHGRI.

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

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

Higher Education Institutions

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

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

• 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)

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)
• 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.

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

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

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

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

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

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

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

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

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

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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

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

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

The letter of intent should be sent to:

Stephanie A. Morris, Ph.D.
National Human Genome Research Institute (NHGRI)
Telephone: 301-435-5738
Email: [email protected]

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

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

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

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

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

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

Senior/Key Personnel should demonstrate scientific, administrative, technical, and management expertise consistent with the objectives of the Coordinating Center. This should include experience in facilitating collaborations, coordination of large research efforts, website design and management, and management of selection and disbursement of subawards.

The PD(s)/PI(s) must designate a dedicated project manager to direct the day-to-day operations of the Coordinating Center. A PD/PI may serve as the project manager.

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

• Budget requests should include support for the Genome Technology program’s annual meetings (approximately 200 participants) to cover costs for meeting facilities and logistics, participant food and beverages, and travel and accommodations for 4-6 outside speakers.
• Budget request should include support for the Centers of Excellence in Genomic Science (CEGS) program’s annual meetings (approximately 120 participants) to cover costs for meeting facilities and logistics, and participant food and beverages.
• For all annual meetings, budgets should include costs for attendance by appropriate Coordinating Center members.
• Budget requests for years 2-4 must include $750,000 per year to execute subawards from the Opportunity Funds program. This should be detailed in the budget for these years under F. Other Direct Costs, as the single line item "Opportunity Funds".

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

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

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

Research Strategy: In the Research Strategy, applicants should propose plans, approaches, and potential alternative strategies for carrying out the activities of the Coordinating Center described in the Research Objectives. The Research Strategy should consist of the following subsections. Details about what should be discussed in each section are described below.

1. Overview of the Coordinating Center

• Provide an overview of how the Coordinating Center will be structured to facilitate the Center’s objectives and enhance technology development efforts supported by NHGRI.
• This section should include a description of previous experience in facilitating collaborations and coordination of large, complex research efforts, appropriate expertise in technology development, as well as a description of the staffing and management structure for each objective without duplicating information in biosketches.
• Applicants should also include their plans for collaborating with NHGRI-funded technology development grantees and NHGRI staff in the development of approaches and strategies relevant to meeting the Coordinating Center s objectives.
• If there are any additional responsibilities that are not detailed in the FOA but are considered necessary for operation of the Coordinating Center, applicants should note them in this section and describe potential approaches.

2. Plans and Approaches to Facilitate Collaborations and Promote Standards in Genomic Technologies

• Describe plans for organizing annual investigator meetings for the Genome Technology and CEGS programs. This should include descriptions of needed logistical and operational management.
• Propose plans for coordinating genomic technology standards working groups and other working groups as described in the Research Objectives. These should include strategies for consensus building, development of recommendations, and promotion of group outcomes, as well as approaches for facilitating interactions with investigators and groups outside of the Genome Technology program.
• Provide strategies and approaches for enabling communication and coordination of program activities such as establishment of teleconferencing platforms and any needed communication platforms.
• Applicants are encouraged to propose and justify any other activities relevant to facilitating collaborations and coordinating scientifically focused discussion groups.

3. Plans and Approaches to Disseminate Advances and Develop Outreach and Community Engagement Approaches

• Provide a strategy for development and maintenance of the Genome Technology program website. Within this strategy, applicants should detail a plan for website design utilizing a portable software platform and plans for transferring this platform and any other Coordinating Center generated resources to the government (or another Center) at the completion of the Center’s project period.
• Propose and describe strategies for developing technology transfer informational resources outlined in the Research Objectives. For example, these may include webinars, web-based tutorials, in-person presentations, and specialized sessions at the annual meetings.
• Propose and describe strategies that include approaches for developing and promoting educational materials and other informational resources.
• Provide plans for outreach and community engagement. This should include an overview of target audience(s) and methods.
• Where applicable, propose and justify any other activities relevant to disseminating advances and developing outreach and community engagement approaches.

4. Plans and Approaches to Provide Opportunity Funds for Promising Small-scale Work

• Propose and describe a management plan for the Opportunity Funds program that includes a description of the administrative structure, process for solicitation, review, and selection of projects, recommendation process for NHGRI review and approval, procedures for funds disbursement, and plans for monitoring and reporting progress.
• Applicants should also describe plans for interacting with the institutions of awardees and for regularly reporting on awardee progress, expenditures, and management of the Opportunity Funds program.
• As needed, propose and justify any other activities relevant to management of the Opportunity Fund that are not detailed in this section.

6. Timeline

• Provide a detailed timeline (e.g., Gantt chart) of Coordinating Center activities and milestones to track progress towards the Center’s objectives. This should be organized by month and year.

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

Applicants to this FOA should provide plans regarding the sharing needed to achieve the Coordinating Center's objectives that are not otherwise described in the Research Strategy,as appropriate and consistent with achieving the goals of the program. If not documented elsewhere, these should include plans for managing the intellectual property concerns of investigators during annual meetings, and any other opportunities in which investigators share information with the Coordinating Center. Plans should also be included for documenting and freely sharing any software or methods developed under this award,as appropriate and consistent with achieving the goals of the program.

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

Appendix:

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

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.

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

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

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

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

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

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

This initiative is not subject to intergovernmental review.

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

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

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

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

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

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.

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:

The emphasis and priority of this FOA are the coordination of the NHGRI Genome Technology program and the interrelated efforts that comprise this program. The NHGRI Technology Development Coordinating Center will be asked to organize and coordinate efforts as described in this FOA that will enable all supported projects to accelerate technology development and progress in the field of genomics. Coordinating Center objectives are to be performed in collaboration with NHGRI staff. Accordingly, reviewers will evaluate prior experience in managing large, complex research efforts and the potential for the Coordinating Center to provide capabilities in developing the infrastructure to support program coordination and assist in achieving program goals.

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

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

Does the proposed Center address the needs of the technology development research programs that it will serve, pertaining to the objectives of this FOA? Is the scope of activities proposed for the Center appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research programs and genome technology development?

Are the PD(s)/PI(s) and other personnel well suited to their roles in the Center? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing large, complex research efforts? Do the investigators demonstrate significant experience with coordinating collaborative multidisciplinary research? Do they have appropriate expertise in technology development? If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach and organizational structure appropriate for the Center? Does the applicant have experience overseeing selection and management of subawards? Are sufficient expertise and effort provided to realistically manage the day-to-day operations of the Center? Where needed, are the PD(s)/PI(s) and other personnel likely to accomplish the objectives of the Center in a collaborative manner with NHGRI staff?

Does the application propose novel organizational concepts and management strategies in coordinating the technology development research programs the Center will serve? Are the concepts and strategies novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts and management strategies proposed? Does the application propose novel strategies for the development of informational resources and dissemination of program advances?

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the technology development research programs the Center will serve? Are potential problems and alternative strategies presented? Are an appropriate plan for work-flow and a detailed timeline proposed? Are the plans for accomplishing the objectives of the Center adequate and likely to be effective? How sufficient are the approaches for facilitating collaborations and leading efforts to promote genomic technology standards? Are the plans for organization and logistical management of these activities sufficient and realistic? Are the strategies for developing and promoting educational and informational resources likely to engage the broader biomedical research community and raise awareness of genome technology development?

For the Opportunity Funds program, is the process for application solicitation, review, recommendation, and awarding sufficiently detailed and is an adequate administrative structure proposed? Are the plans proposed for interacting with awardee institutions adequate? Is information provided on how the Center will monitor and report on awardee progress, expenditures, and management of the Opportunity Funds program?

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?

Will the institutional environment in which the Center will operate contribute to the probability of success in facilitating the technology development research programs it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Center proposed? Will the Center benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?

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

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

Not Applicable

Not Applicable

Not Applicable

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

Not Applicable

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

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

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

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

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

As part of the scientific peer review, all applications:

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

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 submitted in response to this FOA. 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.
• Potential of proposed project to manage large, complex research efforts.

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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

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

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

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

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Institutional Review Board or Independent Ethics Committee Approval: Grantee 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 awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

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

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

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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

Cooperative Agreement Terms and Conditions of Award

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 Parts 75 and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees 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 the awardees for the

project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

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

• Determining research approaches, designing protocols, setting project milestones, and conducting research for carrying out the responsibilities of the Coordinating Center.
• Agreeing to accept close coordination, cooperation, and participation of NHGRI staff in the scientific and technical management of the Coordinating Center.
• Adhering to the NHGRI policies regarding intellectual property, data release, and other policies currently established and newly established during the funding period of the Coordinating Center.
• Collaborating with awardees of the NHGRI Genome Technology program, NHGRI Centers of Excellence in Genomic Science (CEGS), and other NHGRI-funded genome technology development projects.
• Coordinating, managing, and participating in annual program meetings.
• Leading and organizing working groups that support the discussion and exchange of ideas across the NHGRI Genome Technology program.
• Preparing and disseminating working group and program meeting minutes, as appropriate.
• Accepting and implementing common guidelines and procedures developed for the NHGRI Genome Technology program.
• Solicitation of project proposals and organization of scientific review for the Opportunity Funds program.
• Management and disbursement of Opportunity Funds through subawards to individual investigators at awarded institutions.
• Providing regular reports (reporting period to be determined in collaboration with NHGRI staff) on outreach and community engagement activities, Opportunity Funds management, and other Coordinating Center activities as determined by NHGRI staff. Any foreign collaborations included as part of working groups are the responsibility of the Coordinating Center to report to NIH. NIH reserves the right to ask individual research projects to report as well.
• Where opportunities are identified, coordinating and collaborating with other NHGRI research programs.
• Where opportunities are identified, coordinating and collaborating with other research programs, within and outside of the NIH, that engage in genome technology development and other efforts in alignment with NHGRI's Genome Technology program.
• Data/software ownership and transition to another grantee:
• A fundamental objective of this cooperative agreement is to ensure that the valuable data, products, and resources provided by the Coordinating Center remain available without interruption to the research community if awardee withdraws or otherwise can no longer manage the resource or the award is terminated by the NIH.
• Consistent with 45 C.F.R. 75.322, the awardee will own the data generated and software developed by the awardee, and it will be able to continue to use these data and software upon expiration or termination of the award. NIH will have unrestricted cost-free access and use of the data, resources and software generated by the awardee, including the right to transfer said data and/or software to other NIH-funded and/or managed resource projects, at the NIH's sole reasonable discretion upon termination or expiration of this cooperative agreement.
• Ownership of the data and software that may be hosted (but not created) by the Coordinating Center remains with the data and software providers.
• Open Source Technology: Capabilities and software built as part of Coordinating Center must be delivered under an open source model. Organizations may propose to use proprietary platforms, so long as the requirements for data transparency and interoperability are maintained.
• Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

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

NIH staff designated as project scientists will have substantial programmatic involvement that is above and beyond the normal stewardship role in the conduct of the Coordinating Center's activities. However, the role of NHGRI will be to facilitate and not to direct the activities of the Coordinating Center. Specifically, the project scientist will:

• Negotiate objectives, including timelines, with the Coordinating Center awardee as necessary.
• Help coordinate collaborative research efforts that involve multiple components of the NHGRI Genome Technology program and the NHGRI CEGS program.
• Assist the Coordinating Center with the development, if needed, of policies for dealing with situations that require coordinated action.
• Provide advice on the management and technical performance of the Coordinating Center.
• Assist in promoting informational resources and other materials developed in the course of the Coordinating Center's award to the broader biomedical research community.
• Serve on working groups of the Genome Technology program, as appropriate.
• Coordinate review and approval by NHGRI of recommended Opportunity Funds projects.
• Serve as a liaison to other NIH Institutes/Centers and with groups within and outside of NIH that are similarly involved in genome technology development.
• Periodically report progress to NHGRI Leadership.
• Additionally, an NHGRI Program Director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The assigned Program Director may also serve as the NHGRI Project Scientist.

Areas of Joint Responsibility include:

• The Coordinating Center PD(s)/PI(s) will be expected to work collaboratively with NHGRI-funded technology development grantees and NHGRI staff to develop and disseminate informational resources to the broader biomedical research community.
• Close interactions between the Coordinating Center and participating program investigators will be required, as well as significant involvement from NIH to coordinate NHGRI technology development programs. The Coordinating Center PD(s)/PI(s), the NHGRI Project Scientist, and the NHGRI Program Director are expected to attend annual program meetings.
• For the Genome Technology program, working groups are expected to be developed to discuss genome technology standards and other topics of interest determined by program investigators. As needed, NHGRI staff will work with the Coordinating Center PD(s)/PI(s) and personnel to create working groups focused on these topics. Working groups and other Coordinating Center activities may involve participants from other NIH programs or groups outside of NIH. The Coordinating Center PD(s)/PI(s) will work collaboratively with the NHGRI Project Scientist to interact with other relevant NIH programs and groups outside of NIH, as needed, to promote synergy among genome technology development efforts.
• The NHGRI project scientist will also work with the Coordinating Center PD(s)/PI(s) to help define and prioritize research needs to be supported through the Opportunity Funds program.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Genome Technology program 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 individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee'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.

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

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

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

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

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

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

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

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

Stephanie A. Morris, Ph.D.
National Human Genome Research Institute (NHGRI)
Telephone: 301-435-5738
Email: [email protected]

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

Donna Morris
National Human Genome Research Institute (NHGRI)
Telephone: 301-827-2745
Email: [email protected]

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

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