Participating Organization(s)	National Institutes of Health (NIH) National Cancer Institute (NCI)
Components of Participating Organizations	National Human Genome Research Institute (NHGRI)
Funding Opportunity Title	Genomic Resource Grants for Community Resource Projects (U41)
Activity Code	U41 Biotechnology Resource Cooperative Agreements
Announcement Type	Reissue of PAR-11-095
Related Notices	May 10, 2017 - New NIH "FORMS-E" Grant Application Forms and Instructions Coming for Due Dates On or After January 25, 2018. See NOT-OD-17-062. May 8, 2017 - This PAR has been reissued as PAR-17-273. NOT-OD-16-004 - NIH & AHRQ Announce Upcoming Changes to Policies, Instructions and Forms for 2016 Grant Applications (November 18, 2015) NOT-OD-16-006 - Simplification of the Vertebrate Animals Section of NIH Grant Applications and Contract Proposals (November 18, 2015) June 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same. May 5, 2014 - Notice of National Cancer Institute (NCI) Participation in PAR 14-191. See Notice NOT-CA-14-034.
Funding Opportunity Announcement (FOA) Number	PAR-14-191
Companion Funding Opportunity	None
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.172, 93.393
Funding Opportunity Purpose	Genomic research has had substantial impact on biomedical research, in large part because of the open sharing of data (often prior to publication) and resources with the greater research community. To facilitate genomic research and the dissemination of its products, NHGRI supports resources that are crucial for disease studies, model organism studies, and other biomedical research. Awards under this FOA will support the development and distribution of genomic resources that will be available to and valuable for the broad research community, using cost-effective approaches. Such resources include (but are not limited to) informatics resources (such as human and model organism databases, ontologies, and coordinated sets of analysis tools), comprehensive identification and collections of genomic features (such as structural variants or functional genomic elements), and standard data types produced for central sets of samples (such as 1000 Genomes or GTEx samples).

Posted Date	April 24, 2014
Open Date (Earliest Submission Date)	May 30, 2014
Letter of Intent Due Date(s)	30 days before the application due date
Application Due Date(s)	June 30, 2014; September 25, 2014; January 25, 2015; May 25, 2015; September 25, 2015; January 25, 2016; May 25, 2016; September 25, 2016; January 25, 2017 by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	Standard dates apply
Advisory Council Review	Standard dates apply
Earliest Start Date	Standard dates apply
Expiration Date	January 26, 2017
Due Dates for E.O. 12372	Not Applicable

NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

Required Application Instructions

It is critical that applicants follow the 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) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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

Genomics has had substantial impact on biomedical research, in large part because of the open sharing of data (often prior to publication) and resources with the greater research community. The widespread availability of genomics resources provides the entire community with comprehensive sets of data and materials of defined and uniform high quality, allows researchers to compare methods and results with the same sets of samples or reagents, allows researchers to use integrated and documented sets of analysis tools and frameworks, allows the integration of multiple data types through use of the same sets of samples or other resources, and promotes the efficient use of funds by not supporting redundant efforts.

NHGRI currently supports a number of genomics resources. Examples include model organism databases (MODs), the Genome Ontology (GO), PhenX, and collections of structural variants. The resource projects that NHGRI has funded share several key characteristics:

1. They fill a demonstrable need and have a wide impact, well beyond the field of genomics itself.

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

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

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

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

Awards under this FOA will support genomic resource projects, either for the continued support of genomic resources of broad value to the research community or for the development of new ones. A major goal of this FOA is to provide access to these genomic resources by the research community. Generally this will require awardees 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):

• Genome informatics resources: A genome informatics resource is a project that collects, curates, integrates, and distributes information related to genes, sequences, phenotypes, and other genetic and genomic information. Awards may support the development, maintenance, and distribution of genomic informatics resources. Microbial and microbiome databases are generally not appropriate for NHGRI support. Applicants are encouraged to consult Scientific/Research staff about all such resources.
• Collections of coordinated tools and frameworks for analysis: NHGRI will support the development and implementation of sets of related analysis tools or frameworks that can be applied to particular types of 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. The coordination of the analysis tools allows users of all experience levels to use many of the tools together efficiently.
• Community data standards and ontologies: These resources are needed to describe data in standard ways so that they can be compared and integrated across studies. Awards may be made to support groups to work with the community to develop consensus standards and ontologies that will be widely used by researchers.
• Collections of genomic data: NHGRI will support the comprehensive collection, production, and distribution of data about specific genomic features, such as structural variants, functional genomic elements, or protein interactions, and the collection of standard data types in central 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 on the basis of the value of the data produced, especially when multiple data types are to be produced on central sample sets. This FOA will support awards for the discovery of comprehensive data about features not currently addressed by existing programs. When possible, these data should be submitted to central databases such as dbSNP or GEO. Some existing NHGRI programs, such as ENCODE, the large-scale genome sequencing program, and KOMP, coordinate the collection of data about certain types of 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. When possible, the materials generated should be deposited in a standard repository, such as DNA clones in the appropriate clone repository or blood samples in the Coriell Institute for Medical Research. 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 need to have unusual general usefulness and strong programmatic need. Generally, samples or reagents would be supported only if they are part of a well-defined NHGRI program; it is essential to check with program staff.
• Competitions or cooperative activities for genomic analysis tools: 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.

Awards for support of resources differ from typical research grants. Many genomic resources, such as data resources, fulfill an ongoing community need and support must be provided as long as that need exists and remains a priority to the community. This means that NHGRI is able to support only a limited number of resources, and that the long-term effects of funding a new resource must be carefully considered. The cost efficiency of the resource is important in consideration for support. Many of the awards made under this FOA will be for ongoing support of existing resources that continue to have value across the entire biological and biomedical research community. NHGRI’s interest is to meet the community needs, not necessarily to continue support for a specific resource; thus applications are accepted from new providers to meet current needs.

As the choice of which resources to support will be determined in large part by NHGRI-defined programmatic needs, all applicants are strongly encouraged, in the early planning stages of applications, to contact the relevant Scientific/Review staff, who can provide advice about whether the proposed resources address programmatic priorities.

To ensure that the awards continue to meet programmatic needs, NHGRI will use the U41 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 assist the coordination of the work with related resources and research projects.

Frequently, the resources will integrate other data sets and help develop or use data and metadata standards.

Applications for resources that support only particular diseases or other specific biological issues should be directed to the appropriate Institute or Center.

Funding Instrument	Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities.
Application Types Allowed	New Renewal Resubmission Revision The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
Award Budget	Application budgets are not limited, but should reflect the needs of the proposed project.
Award Project Period	Applications may request project periods of up to 5 years. The duration must be justified by the proposed work.

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)
• Eligible Agencies of the Federal Government

Other

• Native American Tribal Organizations (other than Federally recognized tribal governments)
• 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.

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
• Of an application with a changed grant activity code.

Applicants can access the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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 Institute staff to estimate the potential review workload and plan the review.

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

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

The letter of intent should be e-mailed to:

Lisa D. Brooks, Ph.D.
National Human Genome Research Institute (NHGRI)
TEL: 301-435-5544
Email: [email protected]

Component Types Available in ASSIST	Research Strategy/Program Plan Page Limits
Overall	6
Project (use for Resource Project)	12
Core (Use for Resource Informatics or Production Core)	12
Admin Core (Use for Management, Dissemination, and Training Core)	6

Additional page limits 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 a multi-component application.

The application should consist of the following components:

• Overall: required
• Resource Project: one required
• Resource Informatics or Production Core: one required
• Management, Dissemination, and Training Core: one required

When preparing your application in ASSIST, use Component Type Overall .

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

SF424 (R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement (Overall)

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Research & Related Other Project Information (Overall)

Follow standard instructions.

Project/Performance Site Location(s) (Overall)

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Research & Related Senior/Key Person Profile (Overall)

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

Budget (Overall)

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

PHS 398 Research Plan (Overall)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is required in the Overall component.

Specific Aims: Provide aims that address the overall goals of the project, including all the components (Resource Project; Resource Informatics or Production; Management, Dissemination, and Training).

Research Strategy: The overview should explain the rationale for the community resource, describe the resource to be generated, document community support for the proposed resource, and explain the anticipated impact of the resource widely across biomedical research. The overview should also include the project's elements, including the technologies that will be used to produce the resource. Applications proposing to develop new databases, repositories, or other resources should clearly explain why there is a need or why the current resources are not adequate.

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 are encouraged to include letters only from those offering specific resources 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 (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, if appropriate for the resources proposed, with the following modifications. These plans should cover all the components of the application, and should be included only in the Overall Component.

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

Specific Plan for Sharing Software: A software dissemination plan, with appropriate timelines, is expected in the application. There is no prescribed single license for software produced in this project; however, reviewers will be asked to evaluate the software sharing and dissemination plan based on its likely impact. A dissemination 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 institutions of education, research institutions, and government laboratories.

2. The terms should also 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 unwilling or unable to do so.

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

5. Given the long-term goals of this initiative to create software and tools for data science research that will serve as a resource to biomedical researchers across the nation, applicants are asked to 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.

Any software dissemination plans represent a commitment by the institution (and its subcontractors as applicable) to support and abide by the plans.

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.

When preparing your application in ASSIST, use Component Type Project.

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

SF424 (R&R) Cover (Resource Project)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Resource Project)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Resource Project)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Resource Project)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Resource Project)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Resource Project)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Resource Project)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

Specific Aims: Provide specific aims for the production of the overall resource.

Research Strategy: The central focus of the project should be the generation of a research resource that is broadly useful. This component should describe the resource in more detail than the Overview Component, how it will be produced, and how it will be integrated or coordinated with related resources.

Complex applications for large awards should include all the elements below. Applications that are less complex will likely require fewer pages and may skip elements below that are not relevant.

The application should include preliminary data that support the technological approach, if appropriate.

Renewal applications should include a progress report.

Other guidance may apply to some, but not all, types of resource applications:

Training about the use of the resource is a common feature of NHGRI community resource awards. For the types of resources where this would be useful, such as informatics tools and data resources, the application should include information on how training in use of the resource will be provided.

If appropriate, the application may have an applied research component to improve the methods used to develop the resource. (Note that hypothesis-driven R21- or R01-like research is not considered applied research). This research component may comprise up to 10 percent of the direct costs of the award.

The resources that NHGRI will support must represent work in genomics that is broadly applicable to many diseases and research questions. If appropriate, applications may include plans for obtaining additional support and co-funding for the resource.

Special requirements for informatics community resource projects

These projects include human or model organism databases and other informatics 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 present a rationale for including or excluding particular data types (incorporating community priorities), and should provide a plan for adding new data types as they arise. In addition to the main data types that are the focus of the resource, the resource should also include types of evidence, measures of data quality, descriptions of curation methods and associated metadata, and attribution of data sources, for both experimental and computational data.

2. The curation processes to be used: These should be described and justified. Processes addressed should include high-quality manual and computational methods as well as extraction of information from the literature. The application should describe the plans to present the curated data and descriptions of the curation process to users. The application should outline the controlled vocabularies that will be used to describe the data. The application should list the amounts of the various data types to be curated.

3. Any plans to leverage and integrate data from other genomics 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 clearly attribute data to other resources.

4. Any plans to coordinate with related data resources: This may include playing an active role in securing agreement on controlled vocabularies and common data exchange formats where necessary. Applicants should discuss their track record in coordinating with other resources.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide.

The resource sharing plans should be provided only in the Overall Component.

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.

Applications that involve human subjects, such as ones proposing to collect samples from people, must provide a template of the consent form to be used. Consent forms that allow broad sharing of de-identified data are strongly preferred; justification must be provided for projects that propose anything less than broad sharing. Similarly, any other restrictions on use of the data (such as for the study of particular diseases) must be stated and justified; such conditions lower the general value and thus programmatic interest in these samples

Planned Enrollment Report (Resource Project)

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

PHS 398 Cumulative Inclusion Enrollment Report (Resource Project)

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

When preparing your application in ASSIST, use Component Type Core.

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

SF424 (R&R) Cover (Resource Informatics or Production Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Resource Informatics or Production Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Resource Informatics or Production Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Resource Informatics or Production Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Resource Informatics or Production Core)

In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.

In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component. Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.

If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Resource Informatics or Production Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Resource Informatics or Production Core)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

Specific Aims: Provide the aims for the production elements of the resource. Depending on the resource, these may be informatics elements, biological material collection and processing, or data production.

Research Strategy: The central focus of the project should be the generation of a research resource using established, state-of-the-art technologies. All applications should include well-defined goals and milestones that describe what will be accomplished during the award period. Data production and curation should become more efficient over time; the application should describe how this will be achieved. Applications should include plans for distributing the data, software, or biological materials, since the major goal of this program is to provide wide access to broadly useful resources. Applicants should describe how they plan to provide outreach to the community to enable researchers to use the resource effectively. Applications should also 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 must be transferred to NIH or NIH-approved institutions if they were not already placed in lasting databases or repositories accessible to the broad scientific community. All software must be made widely available to the broad scientific community.

This section should describe in detail how the specific aims will be accomplished, production methods, expected outputs, metrics for production and quality control, 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. The investigators who will be responsible for the project should be indicated and their roles described.

Complex applications for large awards should include all the elements below. Applications that are less complex may require fewer pages and may skip elements below that are not relevant.

Special requirements for informatics community data resource projects

1. The quality control procedures to be used: The development and use of various quality control methods are encouraged, but should be justified based on how they benefit the resource and avoid generating erroneous data and propagating errors to automatically annotated records. The proposed metrics of data quality should be described, including discussion of how comprehensive the data will be. The application should indicate the values of these quality metrics that the resource expects to reach.

2. The plans for maintaining the stability of the resource: Issues that should be addressed include, but are not limited to, the frequency of data versioning, API (application programming interfaces) and web services modifications, changes to data cross-referencing with other sources, and consistency of user interfaces.

3. Plans to improve curation: The application should describe the types of curation tools needed to generate the information for the resource, and how the curation process will be made more efficient. This includes ensuring that curators have the appropriate training and tools. The application may describe tools in use as well as propose the development of improved or new tools, which should be focused on the needs of the project.

4. Any plans to scale up the curation process: This includes the development of scalable methods to speed up both manual and computational curation processes and to incorporate large data sets. The development of these methods should be focused on the resource rather than being open-ended research activities. These methods should enable the resource to curate large data sets more efficiently.

5. If appropriate, how community annotation would be incorporated into the resource: Providing such a mechanism is recognized as a challenge, but efforts should be made to engage the user community and benefit from its knowledge. Applications should describe how this information would be solicited, vetted for quality, incorporated into the project, and attributed to submitters.

6. The plans for obtaining input on user needs: The application should describe how use of the elements of the resource will be monitored, and how, either continuously or periodically, user input and broad assessments of user needs will be done to inform priority setting.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide. The resource sharing plans should be provided only in the Overall Component.

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

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.

Planned Enrollment Report (Resource Informatics or Production Core)

This information should be provided only in the Resource Project Component)

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

PHS 398 Cumulative Inclusion Enrollment Report (Resource Informatics or Production Core)

This information should be provided only in the Resource Project Component)

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

When preparing your application in ASSIST, use Component Type Core .

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

SF424 (R&R) Cover (Management, Dissemination and Training Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Management, Dissemination and Training Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Management, Dissemination and Training Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Management, Dissemination and Training Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Management, Dissemination and Training Core)

In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.

In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.

Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.

If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Management, Dissemination and Training Core)

Budget forms appropriate for the specific component will be included in the application package.

Funds should be requested in the Consultant Costs category of the budget to support SAB travel expenses for an annual meeting.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Management,Dissemination and Training Core)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

Specific Aims: Provide the aims for management of the resource, access to and dissemination of the resource, and, if appropriate, training for the user community in how to access and use the resource.

Research Strategy:

Management

The administrative structure of the project should be described. This section should include the organizational structure and staff responsibilities, progress reporting, and the Scientific Advisory Board (if one is proposed).

Organizational structure and staff responsibilities

The organizational structure of the project should be described. Issues that should be addressed include how the PD/PI and the project staff will be organized with respect to the project activities, how differences of opinion will be resolved, the scientific and technical expertise of the staff who will run the resource development activities, and their distribution of effort across their areas of responsibility.

Scientific Advisory Board (required for complex projects)

The PD/PI should appoint a Scientific Advisory Board (SAB) to advise on 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 and agendas. 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 the 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.

Access and dissemination

The access and dissemination activities will vary according to the size and goals of the project. Applicants should include a well-described plan for access to and dissemination of the resource and its contents, consistent with achieving the goals of this program. The resource materials or data should be easily accessible by the scientific community. 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 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 access and dissemination. In these cases, 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.

For data resources, it would be appropriate to employ multiple methods of querying, including simple web interfaces for standard queries and tools such as APIs (application programming interfaces) or web services for more complex queries. The application should provide information about the applicant’s experience with building interfaces, and statistics on their use. Applications should describe the plans to make the data, data schema, and tools in the resource downloadable by users.

In all cases, the materials or data should be made available rapidly after verification of their quality.

A robust web presence may be appropriate for informatics resources and some other types of resources. If appropriate, the web site should provide information about:

(1) the project’s focus and capabilities, including research objectives if appropriate;

(2) how to interact with the resource and provide feedback;

(3) contact information;

(4) current newsworthy items;

(5) links to online tutorials, if appropriate;

(6) the availability of software, reagents, and other resources, as applicable; and

(7) links to related NIH-funded resources.

Training (if appropriate)

Some projects produce resources that require user training to maximize their utility. Where appropriate, the application must describe a plan and allocate sufficient resources for training both specialists and non-specialists to make the best use of the resource. Examples include presentations, short courses, or symposia offered independently or in conjunction with society meetings attended by the user community; web-based tutorials; and user manuals and training guides to describe the features of the resource.

The project may need to provide user support services with consultation and technical assistance to those using the resource. Applicants should describe their experience in providing user support, evidence of the quality of that service, and the plans to implement or continue this service.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

The Resource Sharing plans should be provided only in the Overall Component."

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.

Planned Enrollment Report (Management, Dissemination, or Training Core)

(This information should be provided only in the Resource Project Component)

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

PHS 398 Cumulative Inclusion Enrollment Report (Management, Dissemination, or Training (Not applicable)

This information should be provided only in the Resource Project Component.

When conducting clinical research, follow all instructions for completing Cumulative Inclusion

Enrollment Report as described in the SF424 (R&R) Application Guide.

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.

Part I. Overview Information contains information about Key Dates. 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.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. 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.

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.

For information on how your application will be automatically assembled for review and funding consideration after submission go to: https://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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.

Important reminders:
All PD(s)/PI(s) and component Project Leads 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.

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 (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact NIH program staff at least 6 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 our Post Submission Application Materials policy. , with the following additional instructions:

• A progress update may be submitted, limited to 2 pages.
• The update is limited to new data supporting the original aims; additional aims or tasks cannot be proposed.
• The update must be transmitted as a PDF file, by the Authorized Organization Representative (AOR) of the applicant organization, by e-mail to the Scientific Review Officer.
• The update must be transmitted at least 45 days before the peer review meeting. Check your NIH Commons page for the assigned peer review date.

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.

Significance

Does the project address an important problem or a critical barrier to progress in the field? 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?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or 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?

Innovation

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 new scalable methods to speed up manual and computational annotation? Will the resource develop new ways to meet the needs of its user communities? Will the resource develop appropriate methods for soliciting, collecting, vetting, and incorporating community annotation?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? 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?

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?

Environment

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.

FOA-Specific Review Criteria

Needs assessment: The applicant is responsible for identifying the research communities that will use the resource. How is the balance of the component activities proposed consistent with the needs and opportunities presented by the potential user communities?

Community outreach: How adequate are the plans to inform the scientific community about the resource?

Resource maintenance: How adequate are the plans to collect and maintain data? 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 be able to access the resource data or materials, including plans to make available the entire resource and data schema?

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 explain to members of the research community how to use the resource, if appropriate?

Protections for Human Subjects

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.

Inclusion of Women, Minorities, and Children

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.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

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.

Resubmissions

For Resubmissions, the peer review 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.

Renewals

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

Revisions

For Revisions, the peer review 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.

Applications from Foreign Organizations

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.

Select Agent Research

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).

Resource Sharing Plans

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) Genome Wide Association Studies (GWAS).

Budget and Period of Support

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 submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Council for Human Genome Research. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.
• Broad relevance to many diseases and research questions
• Compliance with broad data 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.

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 the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants 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.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), 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 Research Resource group 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 and materials produced as part of this project are released appropriately.
• Ensure that software developed as part of this project is released according to the software sharing plan.
• 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 NHGRI Program Director.
• If appropriate, establish and run a Scientific Advisory Board to obtain advice about priorities and approaches for the resource.

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 HHS, PHS, and NIH policies.

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 NHGRI 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.
• 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, if needed, of policies.
• 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.
• Retain the option to recommend the withholding or reduction of support from any group 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 NHGRI 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 Non-Competing Continuation Grant Progress Report (PHS 2590 or 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.

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)

Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: https://grants.nih.gov/support/index.html

TTY: 301-451-5939
Email: [email protected]

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)
Telephone: 301-945-7573
TTY 301-451-5936
Email: [email protected]

Lisa D. Brooks, Ph.D.
National Human Genome Research Institute (NHGRI)
Telephone: 301-435-5544
Email: [email protected]

Vivien R. Bonazzi, Ph.D.
National Human Genome Research Institute (NHGRI)
Telephone: 301-451-8276
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: 301-402-0838
Email: [email protected]

David Ruane
National Human Genome Research Institute (NHGRI)
Telephone: 301-451-7928
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 Parts 74 and 92.