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

Background

Genomics has had a strong influence on biomedical research, in large part because of the open sharing of data and resources with the research community. The widespread availability of genomic resources provides the entire community with comprehensive datasets and materials of uniform high quality, and allows researchers to compare methods and results, to integrate multiple data types using the same sets of samples or other reagents, and to use integrated and documented sets of analysis tools.

NHGRI currently supports several genomic resources. Examples include the Human Reference Genome Consortium; ClinGen, OMIM, and GENCODE to support annotation of genes and variants and associations with phenotypes; model organism databases (FlyBase, ZFIN); ontologies for genomic features and phenotypes (the Gene Ontology (GO) Consortium, PhenX); analysis platforms (Galaxy, Bioconductor), and collections of DNA structural variants. The resource projects that NHGRI supports share several key characteristics:

1. They fill a demonstrated need and are widely used.

2. They are comprehensive in scope, covering, for example, the entire genome or all genes of an organism.

3. They make data, materials, or software broadly available to all researchers in a user-friendly manner.

4. They use standards, such as for metadata, formats, and documentation, to enable aggregation, integration, and broad use.

5. They use established, state-of-the-art, cost-efficient, and robust production methods to generate and distribute high-quality products of lasting value.

6. They are unique, and do not duplicate resources that are otherwise available.

Scope

Awards under this FOA will support the continued development of genomic resources of broad value to the research community or the establishment of new ones. The major goal of this FOA is to provide access to these genomic resources by the research community; awardees are expected to actively disseminate the data and resources supported under these awards.

Resources for which applications will be accepted under this FOA include (but are not limited to):

--Genomic data resources: Awards may support the development and maintenance of resources that collect, curate, integrate, and distribute information related to comprehensive sets of genes, variants, sequences, phenotypes, and other genetic and genomic information. Frequently, the resources will integrate other data sets and will use or help develop data and metadata standards. The data should be from humans or biomedically relevant species. Microbial and microbiome databases are generally not appropriate for NHGRI support. Applicants are encouraged to consult program staff about all such resources.

--Collections of analysis tools and software platforms: Awards may support the development, maintenance, and distribution of analysis toolsets that can be applied to genomic data, to allow users to work with those data types and integrate them with related data types to provide a deeper understanding of biological phenomena.

--Community data standards and ontologies: These resources develop and support data standards and ontologies with broad relevance to genomic research and encourage community engagement.

--Production of genomic data: Awards may support the comprehensive production and distribution of data about specific genomic features, such as DNA structural variants, functional genomic elements, or protein interactions. They may support the collection of standard data types in broadly used sets of samples, such as the 1000 Genomes samples or GTEx samples. The data production approaches should be well established and thus may be considered not innovative enough for regular R01 awards, but should be justified based on the value of the data produced, especially when multiple data types are to be produced on the sample sets. Some existing NHGRI programs, such as ENCODE, the large-scale genome sequencing program, and KOMP, coordinate the collection of data about certain types of genomic features; applications in these areas are not appropriate for this FOA and should be directed to those programs.

--Collections of samples or other biological materials: Awards may be made for the collection or generation of comprehensive sets such as cell lines, DNA clones, and gene or regulatory region knockout resources for functional analyses. Generally, samples or reagents would be supported only if they are part of an already-defined NHGRI project; it is essential to check with program staff. When possible, the materials generated should be deposited in a standard repository, such as DNA clones in the appropriate clone repository. If an appropriate repository is not available, the application should include a plan for continued maintenance and distribution of the materials during the award period and after it ends. Applications proposing to collect samples restricted to research on particular diseases are more likely to be appropriate for the Institute or Center supporting research on those diseases rather than NHGRI. Sets of samples that are characterized for many phenotypes are generally not appropriate for NHGRI support; they would have to provide unusual general usefulness for a strong programmatic need.

--Competitions or cooperative activities for genomic analysis tools: For example, applicants may organize competitions to predict the molecular function of genetic variants, based on data they produce or obtain, and organize meetings for participants to compare analysis methods. Such activities may be appropriate if they support analysis goals that are of high programmatic priority, involve many participants, and distribute the results broadly; applicants are encouraged to consult Scientific/Research staff.

Interests of participating Institutes: NHGRI in interested in resources that apply to many biomedical questions and diseases. NCI is interested in any of the above types of resources that focus on cancer.

Awards supporting resources differ from typical research (e.g., U01) grants. Genomic resources funded under this FOA must address needs across the broad genomics research community. NHGRI and NCI will provide funding as long as that need is demonstrated and remains a priority for the community.

NHGRI- and NCI-defined programmatic needs will determine in large part which resources are supported. Program staff will consider carefully the long-term effects of funding a new resource. Thus, all applicants are strongly encouraged, early in the planning stages of applications, to contact the relevant program staff, who can advise whether the proposed resources address programmatic priorities.

Applications for resources that support only particular diseases or other specific biological questions, such as human development or mechanisms of mutation, are not appropriate for this FOA. NCI will support only resources that are broadly applicable to cancer, and are not limited to specific cancer types.

To ensure that the awards continue to meet programmatic needs, this FOA will use the U24 cooperative agreement mechanism for support of resources. Under this mechanism, program staff will have significant programmatic involvement in the form of assistance and guidance, although the awardees will have primary responsibility for designing the project and doing the work. Program staff will monitor progress on achieving the aims, particularly how well the resource is meeting the community needs for which it was created. Program staff will work with the awardee on any modifications of the aims as technologies and scientific needs change. Program staff will also help coordinate the work with related resources and research projects.

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

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

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

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

Other

• 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)

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant Organizations

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The letter of intent should be e-mailed to:

Christopher Wellington, B.S.
National Human Genome Research Institute (NHGRI)
Telephone: 301-480-3496
Email: [email protected]

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

for this FOA, 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 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.

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, with the following additional instructions:

Research Strategy:

--Justification: The application should explain the rationale for the community resource, describe the user community that will use the resource, document community uptake and support for the proposed resource, and explain the anticipated impact of the resource widely across genomic and biomedical research. Applications proposing to develop new databases, repositories, or other resources should explain why there is a need or how they complement other related resources.

--Production of the resource: The central focus of the project should be the generation of a research resource using established, state-of-the-art technologies. The application should describe the resource to be generated and how it will be produced. Robust but non-innovative production methods may be appropriate for a broadly used resource; applicants should highlight any innovative aspects.

These elements should be included, if appropriate:

1. How the specific aims will be accomplished, expected outputs, and quarterly milestones for each aspect of the production activity. For resources that are producing or curating data over several years, the application should describe how the approaches will become more efficient and cost-effective over time, and how that will be monitored.

2. The technologies that will be used to establish and maintain the resource, and preliminary data that support the technological approaches.

3. The quality control procedures to be used: The proposed goals and metrics of data quality should be described, including discussion of how comprehensive the data will be. The quality control methods should be described and justified.

4. The plans for updating the resource: Issues that should be addressed include the frequency of data versioning, API (application programming interfaces) and web service modifications, changes to data cross-referencing with other sources, and consistency of user interfaces.

5. The plans for monitoring the use of the resource: The application should describe how use of the elements of the resource will be monitored, the types of users that the resource supports, and the impact of the resource on the research community.

6. The plans for obtaining input on user needs: The application should describe how user input and assessments of user needs will be done to inform priority setting, and how responsiveness will be monitored.

7. How the resource will be integrated or coordinated with related resources.

8. Support of a resource and distribution of resources and data after the period of an award: Applications should include plans for maintenance and distribution of the resource beyond the period of the award. Such plans should acknowledge that, at the end of the project period, all data or resources generated by the project may need to be transferred to other resource projects, as designated by NHGRI or NCI, if they were not already placed in lasting databases or repositories accessible to the broad scientific community.

--Accomplishments: Applications for a continuing resource should describe what has been accomplished. Renewal applications should include a summary of past progress as part of the progress report.

--Research to improve the resource: The application may have an applied research component to improve the methods used to develop the resource. This research component may be up to ten percent of the costs of the award.

--Additional funding: Applications should include any plans for obtaining additional support and co-funding for the resource.

--Special requirements for community data resources

These projects include human or model organism databases and other resources that involve curation of data from the literature and integration with other genomic or genetic data. Applications for these resources should also address the following issues:

1. The data types to be included in the resource: The application should justify including or excluding particular data types, incorporating community priorities, and should provide a plan for adding new data types as they arise. The application should list the amounts of the various data types to be curated.

2. The curation processes to be used: These should be described and justified. The application should include the types of evidence, measures of data quality, the controlled vocabularies to be used, and attribution of data sources. The application may describe tools in use as well as propose to develop or improve tools. The application should describe how the curation process will be made more efficient, including developing scalable methods to speed up both manual and computational curation processes and to incorporate large data sets. Any community annotation efforts should be described.

3. Any plans to leverage and integrate data from other genomic data resources: The application should explain which resources were chosen and why the data are appropriate for inclusion in the proposed resource. If data from existing resources that provide similar or overlapping information are included, the application should justify their value and how unnecessary duplication will be avoided. Applications should discuss how the resource will maintain data provenance.

4. Any plans to coordinate with related data resources: This may include agreeing on controlled vocabularies, shared data models, and common data exchange formats.

--Management

The administrative structure of the project should be described, including the organizational structure, the scientific and technical expertise of the staff, their roles and distribution of effort, and how differences of opinion will be resolved.

Scientific Advisory Board (required for projects requesting $500,000 or more direct costs in any year)

The PD/PI should appoint a Scientific Advisory Board (SAB) to advise on the progress and priorities of the resource project. In consultation with the SAB, the project must set priorities for the types and depth of information to be included. The SAB should encourage continuous improvements as methods, data, and needs change with time. A strong emphasis on operating in a cost-effective manner should be established. Applicants should describe how they would appoint and use the SAB, and how they plan to organize advisory board meetings. Applicants should describe previous experiences with advisory panels, how advice was incorporated into a project, and how the advice contributed to a project’s outcome.

New applications should not name proposed SAB members or recruit members to serve on the SAB prior to the peer review of the application. However, they should describe the expertise to be included on the SAB.

--Dissemination

Applicants should describe the plans for dissemination of the data, software, or biological materials, without duplicating material in the Resource Sharing Plan, since the major goal of this program is to provide wide access to broadly useful resources. The materials or data should be made available soon after verification of their quality. For some projects, the materials or data can be provided to established resources for distribution. For example, clone sets can be supplied to the appropriate model organism resource centers or commercial distributors, and DNA structural variation data can be provided to the central genetic variation databases. Some projects, such as MODs or other genome informatics resources, will require a separate infrastructure for dissemination, and both the hardware and software components of this infrastructure should be described. The utility of the dissemination activity should be described along with the process for improving the resource in response to community needs and input. Any web-based dissemination activities should emphasize user-centric design. Applicants should describe their experience with sharing resources.

For data resources, it may be appropriate to use multiple methods of querying. The application should describe the applicant s experience with building interfaces. Applications should describe the plans to make the data, data schema, and tools in the resource downloadable by users or available in the Cloud or shared resources.

A robust web presence may be appropriate for informatics resources and some other types of resources.

--User training (if appropriate)

Some projects produce resources such as informatics tools and databases that require user training to maximize their utility. Such applications should describe how training on use of the resource will be provided for specialists and non-specialists. Examples include presentations, short courses, or symposia offered independently or at society meetings attended by users; web-based tutorials; and user training guides.

The project may need to provide user support services with consultation and technical assistance. Applicants should describe the experience of their team in providing user support, and plans for this service.

--Broad data use: NIH expects that if human subjects data or samples are collected, consent forms will allow for future research use and broad data sharing. Applicants should include a compelling scientific reason for any restrictions that would be placed on the use of the data.

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

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide. Applicants are expected to provide Resource Sharing Plans (Genomic Data Sharing Plan, Data Sharing Plan, Sharing Model Organisms, Software Sharing Plan), if appropriate for the resources proposed, with the following modifications:

• All applications, regardless of the amount of direct costs requested for any one year, should include Resource Sharing Plans.
• Prior to funding, NHGRI or NCI program staff may negotiate modifications to the Resource Sharing Plans with the applicant.

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

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

Protocol and Reagent Sharing Plan: As one of the primary goals of this program is to advance research through the development and broad dissemination of community resources, NIH intends that protocols and reagents produced under this FOA be broadly available, distributed at minimal cost, and without undue intellectual property constraints. Where appropriate, applicants should discuss plans for distributing non-data resources that will be produced, including models, protocols, biomaterials, and reagents.

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

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

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

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

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

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

Consistent with 45 C.F.R. 75.322, the awardee 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. NIH expects that the awardee will grant other resources the ability to use and redistribute the data, including integrating the data with other datasets, without restriction, unless otherwise limited by consent requirements.

Appendix:

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide, with the following modification: applications that involve human subjects, such as ones proposing to collect samples from people, should provide a template of the consent form to be used.

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

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

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

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

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

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

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

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

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

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

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

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

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

This initiative is not subject to intergovernmental review.

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

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

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

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

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

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

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 8 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

Applicants are required to follow the instructions for post-submission materials, as described in the policy.

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

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

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

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

Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Is the proposed resource valuable for the broad genomics research community?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Have the investigators demonstrated that they have shared resources previously?

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? Is the amount of novelty proposed appropriate for the resource proposed?

For informatics community resource projects: Will the proposed resource continually be able to incorporate new data types or data produced by new technologies? Will the resource develop or adopt new scalable methods to speed up computational and manual data annotation? Will the resource develop new ways to meet the needs of its user communities? Will the resource develop appropriate methods for incorporating community annotation?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

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

Are the methods to produce the resource efficient and cost-effective? If the size of the resource is likely to increase over time, will the proposed methods work at increased scale to allow the applicants to meet the goals in an efficient and cost-effective way?

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

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

Needs assessment: How is the balance of the proposed activities responsive to the needs and opportunities of the potential user communities? Is the plan for assessing and monitoring the cost efficiency and impact adequate?

Community outreach: How adequate are the plans to inform the scientific community about the resource and to collect feedback from the users?

Resource maintenance: How adequate are the plans to collect, update, maintain, and publicly release the data and tools developed? How adequate are the plans to ensure that curation is accurate and that error propagation is minimized?

Resource access: How adequate are the plans for researchers to access the resource data or materials, including plans to make available the entire resource and data schema? How well does the resource plan implement the Findable, Accessible, Interoperable and Reusable (FAIR) guidelines?

Service: How adequate are the plans to provide consultation and technical assistance in the use of the resource, if appropriate?

Training: How adequate are the plans for providing educational programs to the research community on how to use the resource, if appropriate?

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

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

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

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

For Renewals, the committee will consider the progress made in the last funding period.

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

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

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

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

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

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

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

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

As part of the scientific peer review, all applications:

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

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications . Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.
• NHGRI will consider broad relevance to many diseases and research questions.
• NCI will consider broad relevance to cancer, rather than to specific cancers.
• Compliance with broad data, software, and resource sharing policies.
• Cost effectiveness of the methods for resource production.

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

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

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

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

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

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

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

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

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

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 Part 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:

The PD/PI will have the primary responsibility for defining the details for the project within the guidelines of FOA and for performing the scientific activities. The PD/PI will agree to accept close coordination, cooperation, and participation of NIH staff in those aspects of scientific and technical management of the project as described under "NIH Program Staff Responsibilities".

The PD/PI of a Community Resource will:

• Determine approaches, design the protocols, set project milestones, and conduct the work.
• Ensure that the appropriate analyses are developed, evaluated, and chosen for implementation.
• Coordinate the processing of particular materials, programs, or data types with groups working with related resources, programs, or data.
• Monitor those materials, programs, or data types during the production of the full-scale resource, and ensure that the resource is quality is high and meets the planned quality standards.
• Work with relevant databases to ensure that data processing pipelines function properly, and make modifications as needed.
• Ensure that the data, software, and materials produced as part of this project are released appropriately according to the Resource Sharing Plans.
• Adhere to the NHGRI policies regarding intellectual property and other policies that might be established during the course of this activity.
• Submit periodic progress reports in a standard format, as agreed upon with the NIH Program Director. These will include metrics of the use and impact on the community, as agreed on with the NIH Project Scientist.
• If appropriate, establish and run a Scientific Advisory Board to obtain advice about priorities and approaches for the resource.

Consistent with 45 C.F.R. 75.322, the awardee 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. NIH expects that the awardee will grant other resources the ability to use and redistribute the data, including integrating the data with other datasets, without restriction, unless otherwise limited by consent requirements.

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

The NIH Project Scientist is a scientist of the NIH extramural staff who will have substantial scientific and programmatic involvement during the conduct of this activity through technical assistance, advice, and coordination. In addition, the Project Scientist will also serve as Program Official providing normal stewardship of the award. However, the role of NIH staff will be to facilitate and not to direct the activities. The NIH Project Scientist will have the following substantial involvement:

• Serve as a liaison, helping to coordinate activities among and for the awardees, including acting as a liaison to the NHGRI and the other Institutes and Centers of the NIH, and as an information resource about extramural genome research activities.
• Work with the PD/PI to define metrics of use and impact on the community.
• Report periodically on the progress of the resource to the Directors of the NHGRI and other NIH Institutes and Centers.
• Assist awardees in the development of policies, if needed.
• Provide advice in the management and technical performance of the investigation.
• Assist in promoting the availability of the resources developed in the course of this project to the scientific community at large.
• May recommend the withholding or reduction of support of any resource funded under this FOA that substantially fails to achieve its goals, fails to remain state of the art in its capabilities, or fails to comply with the Terms and Conditions of the award.

Areas of Joint Responsibility include:

The PD/PI and NIH Project Scientist together will be responsible for evaluating progress in meeting the research community’s needs for the resource.

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 arbitration. An Arbitration Panel composed of three members will be convened: one designee of the awardee, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 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 progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

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

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

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

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

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: [email protected]

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

Christopher Wellington, B.S.
National Human Genome Research Institute (NHGRI)
Telephone: 301-480-3496
Email: [email protected]

Leah Mechanic, Ph.D., M.P.H.
National Cancer Institute (NCI)
Telephone: 240-276-6847
Email: [email protected]

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

Anneliese Galczynski
National Human Genome Research Institute (NHGRI)
Telephone: 301-443-4935
Email: [email protected]

Carol Perry
National Cancer Institute (NCI)
Telephone: 240-276-6282
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.