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
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not 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.

Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed.

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).

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, including Supplemental Grant Application Instructions 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 IC staff to estimate the potential review workload and plan the review.

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

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

The letter of intent should be sent to:

Leroy Worth, PhD
Telephone: 919-541-0670
Fax: 919-316-4606
Email: [email protected]

Component Types Available in ASSIST	Research Strategy/Program Plan Page Limits
Overall	12
Admin Core (Use for the Administrative Core)	6
Core (Use for the Data Repository and Management Core)	12
Research Resource (Use for Statistical Services and Methods Development Resource and Data Sciences Resource)	12

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
• Administrative Core: required
• Data Repository and Management Core: required
• Statistical Services and Methods Development Resource: required
• Data Sciences Resource: 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.

Complete entire form.

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

Follow standard instructions.

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.

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.

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

Specific Aims: Outline the overall aims of the proposed CHEAR Data Center.

Research Strategy: Comprehensively address the main objective of the CHEAR Data Center, which is to provide intellectual and logistical support for the maintenance, analysis, and interpretation of data generated by the CHEAR infrastructure.

As part of this section, describe the following elements:

Background:

• How the proposed CHEAR Data Center will meet the general program objectives as a resource;
• How the proposed Data Center will integrate the diverse expertise of the applicant team to meet the goals of the Center and of CHEAR.

Overall mission/vision for the CHEAR Data Center, including:

• Overview of all components (i.e. Resources and Cores) and their integration;
• Plans for strategic oversight and coordination of effort among components; and
• Plans for collaboration and coordination with the broader CHEAR Network and PRISM programs.

Anticipated challenges/obstacles and alternative strategies to surmount potential obstacles.

Letters of Support: Include letters of support/agreement for any collaborative/cooperative arrangements, subcontracts, or consultants. For program activities to be conducted off site, i.e., at an institution other than the applicant institution, a letter of assurance or comparable documentation, signed by the collaborator as well as the off-site institutional officials, must be submitted with the application.

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

All applications, regardless of the amount of direct costs requested for any one year, must include a Data and Resource Sharing Plan addressing the following:

• The CHEAR Program requires sharing of resources with broad availability of policies, practices, materials, and tools to facilitate collaboration, reuse, and replication, both in other CHEAR supported projects and by other exposure assessment, children’s health and environmental epidemiology researchers. In addition, the CHEAR Program requires the sharing of study data from both the laboratory network and data and statistical resource in a timely manner, and with appropriate privacy and confidentiality protections to facilitate further research, reuse of data, and replication. Thus, the CHEAR Program requires awardees to implement a Resources and Data Sharing Plan consistent with achieving these program goals. The final Resources and Data Sharing plan will be developed by the CHEAR steering committee post award.
• In addition, the CHEAR Program requires sharing of resources that are developed or modified to accomplish aims of this program. This may include, but is not limited to, software, tools, or protocols.
• The goals of software sharing under this program include 1) terms that permit the dissemination and/or commercialization of enhanced or customized versions of the software, or incorporation of the software or components of it into other software packages; and 2) terms of software availability that include the ability of individuals outside the applicant institution and its collaborating organizations to modify the source code and to share modifications with others. If software is developed with support from this program, awardees and their sub-contractors are required to implement software sharing plans consistent with achieving the goals of this program.

The application must also describe plans for:

• Ensuring that data accumulated at Data Center and CC are distributed to other relevant resources in a standard data format; and
• Ensuring that the data accumulated under the Data Center and CC are made publicly available as appropriate to privacy protection agreements and can be retrieved through multiple methods of querying, including simple web interfaces for common standard queries and tools to allow the access to large datasets.

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 Admin Core.

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

Complete only the following fields:

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

Enter Human Embryonic Stem Cells in each relevant component.

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.

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.

• ASSIST will default to Project Lead . If you would like to use a different category, then replace Project Lead below with a different Category (e.g., Core Lead).
• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core 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.
• The U2C PD/PI must serve as the Administrative Core Leader.

Applicants must provide a detailed budget, including justification for all expenditures, for the Administrative Core.

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

The budget for the Administrative Core should include travel for the U2C PD/PI (Core Leader) and other designees to annual Steering Committee and Grantee Meetings. The budget should also include costs associated with internal communications as needed.

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.

Specific Aims: Identify general objectives planned for the Administrative Core along with the main benchmarks that would indicate the accomplishment of these objectives

Research Strategy: The Administrative Core will provide overall administrative and organizational oversight and management of the Statistical Services and Methods Development Resource, the Data Science Resource and Data Repository and Management Core. It will also serve as the primary interface between the Data Center and other units of the overall CHEAR Network (i.e., the CHEAR Coordinating Center and the CHEAR National Exposure Assessment Laboratory Network).

As part of this section, the applicant should address the following:

Overall leadership and personnel capacity that may include but is not limited to the following:

• Administrative, operations, and meeting support staff;
• Business and/or legal expert staff;
• Other staff required to support the Data Center as a whole; and
• Plans and logistical support for meetings of Resource and Core leads as well as other relevant subcommittees;

Support for internal evaluation and self-assessment, including:

• Ability to generate progress reports;
• Ability to assess and anticipate researcher needs; and
• Ability to prioritize and incorporate improvements into operations and software that enhance its utility for research.

Anticipated challenges/obstacles and alternative strategies to surmount potential obstacles.

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

• Generally, Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and GWAS Sharing Plan) are expected, but they are not applicable to this 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.

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

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 (Data Repository and Management 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 (Data Repository and Management Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Data Repository and Management 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) (Data Repository and Management 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 (Data Repository and Management Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Core Lead with Category of Core 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.

The Senior/Key personnel should emphasize experience and expertise in:

• Computer and data science including database/data repository development and management, statistical programming, software engineering, and information technology;
• Environmental health science, epidemiology, and exposure science; and
• Data sharing for human subjects research including the protection of privacy.

Budget (Data Repository and Management Core)

Applicants must provide a detailed budget, including justification for all expenditures, for the Data Repository and Management 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 (Data Repository and Management Core)

Specific Aims: This Core seeks to create a data repository to facilitate access, analysis, and dissemination of data generated within CHEAR. Applicants should outline specific aims to address this goal.

Research Strategy: Applications should describe the following:

• The overall vision of the Data Repository and Management Core and how this meets the CHEAR objectives;
• The proposed process for creating a data repository with the capability to store/aggregate all primary and processed data and associated metadata generated by the CHEAR National Exposure Assessment Laboratory Network;
• Plans to collaborate with the CHEAR Coordinating Center and Laboratory Network to establish a data submission pipeline, quality control metrics, and minimal metadata elements required to deposit CHEAR data in the repository;
• Overall approach and methods to establish a data portal for user-friendly access to CHEAR data (both raw and processed datasets), metadata, and visualization tools. This web-based interface should provide controlled access to both CHEAR participants and the broader scientific community, enable federation to relevant external databases and data resources and facilitate the direct submission to the repository of limited types of additional data generated within and outside of CHEAR for specific collaborative analyses (e.g., genomic data in a specified format);
• Plans to collaborate with CHEAR Coordinating Center and Laboratory Network to develop and implement the policies and procedures for data sharing as well as create systems to facilitate such sharing;
• Ability to ensure data security and maintain confidentiality of personally identifiable information;
• Specific methods for integration of data generated by outside sources in concert with the Data Science Resource;
• Technical capabilities to provide interoperability of the CHEAR data with other databases through federation (e.g. linkage to the Comparative Toxicogenomics Database, dbGAP, ENCODE, GEO, CF Metabolomics, CIDR, RoadMap Epigenomics);
• Tutorials for data access and visualization by a variety of users (na ve users, bioinformaticians, and researchers from a variety of disciplines);
• Technical capabilities and strategies for designing the data repository and management systems in such a way to maximize sustainable functioning in the future, even under limited or no funding; and
• Description of server maintenance, software maintenance and upgrades, and security and backup processes.

As part of this section, the applicant should address the following specific aspects:

How the proposed Data Center will integrate the diverse expertise of the applicant team to meet the goals of the Core.

Operations management, including:

• Ability to ensure efficient and effective day-to-day administrative operations; and
• Coordination with other components of the Resource.

Customer support capacity that may include the following:

• Basic technical support for Investigators participating in CHEAR;
• Communication channels (phone, email, web-based content such as frequently asked questions, and other appropriate mechanisms); and
• Ability to refer to more technical staff for issues requiring more detailed knowledge of programming, databases, statistical or bioinformatics approaches, etc.

Description of server maintenance, software maintenance and upgrades, and security and backup processes.

Discussion of anticipated challenges/obstacles and alternative strategies to surmount potential obstacles.

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

• Generally, Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and GWAS Sharing Plan) are expected, but they are not applicable to this 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 (Data Repository and Management Core)

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 (Data Repository and Management Core)

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 Research Resource.

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

SF424 (R&R) Cover (Statistical Services and Methods Development Resource)

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 (Statistical Services and Methods Development Resource)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Statistical Services and Methods Development Resource)

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) (Statistical Services and Methods Development Resource)

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 (Statistical Services and Methods Development Resource)

• In the Project Director/Principal Investigator section of the form, use Project Role of Resource Director 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.
• The Key and senior personnel should emphasize experience and expertise in:
• Statistics and computational biology including, bioinformatics, statistical programming and statistical methods development; and
• Environmental health science, epidemiology, and exposure science.

Budget (Statistical Services and Methods Development Resource)

Applicants must provide a detailed budget, including justification for all expenditures, for the Statistical Services and Methods Development Resource component.

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 (Statistical Services and Methods Development Resource)

Specific Aims: This Resource seeks to provide statistical consultation and analysis support to investigators utilizing the Laboratory Network resources, as well as support collaborative research efforts, and development and dissemination of new statistical methods and informatics tools. Applicants should outline specific aims to address these goals.

Research Strategy: Applicants must describe how the central objectives of the Statistical Services and Methods Development Resource will be accomplished as outlined in the proposed specific aims for this resource. Address the following aspects:

• Plans for providing statistical, epidemiological and/or bioinformatics support to investigators that will utilize the CHEAR services, from preliminary consulting on study design through performing data analysis and interpreting results;
• Plans for interacting with the Laboratory Network to facilitate quality control and address other data issues that may arise;
• Plans to develop open-source statistical software to facilitate implementation of analytical approaches for children’s environmental health studies as well as training datasets for using packages;
• Plans to support collaborative research efforts, including the establishment of a children’s environmental health research consortium, proposed topics for two to three initial meta-analysis projects, and the approach for completing initial meta-analysis; and
• Plans to develop new statistical and bioinformatics methods to address issues in children’s environmental health, including two to three areas of focus for methods development that will support the overall CHEAR objectives and proposed approaches for each area.

Note: primary data collection to support collaborative research or methods development projects is beyond the scope of this FOA.

As part of this section, the applicant should also address plans for the following:

How the proposed Data Center will integrate the diverse expertise of the applicant team to meet the goals of the Resource.

Operations management, including:

• Ability to ensure efficient and effective day-to-day administrative operations of the Statistical Services and Methods Development Resource; and
• Coordination with other components of the Resource.

Customer support capacity that may include the following:

• Basic technical and statistical support for investigators participating in CHEAR;
• Communication channels (phone, email, web-based content such as frequently asked questions, and other appropriate mechanisms); and
• Ability to refer to more technical staff for issues requiring more detailed knowledge of programming, databases, statistical or bioinformatics approaches, etc.

Description of server maintenance, software maintenance and upgrades, and security and backup processes.

Anticipated challenges/obstacles and alternative strategies to surmount potential obstacles.

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

• Generally, Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and GWAS Sharing Plan) are expected, but they are not applicable to this 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 (Statistical Services and Methods Development Resource)

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 (Statistical Services and Methods Development Resource)

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 Research Resource.

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

SF424 (R&R) Cover (Data Science Resource)

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 (Data Science Resource)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Data Science Resource)

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) (Data Science Resource)

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 (Data Science Resource)

• In the Project Director/Principal Investigator section of the form, use Project Role of Resource Director 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.

The Senior/Key personnel should emphasize experience and expertise in:

• Computer and data science including database/data repository development and management, statistical programming, software engineering, and information technology;
• Environmental health science, epidemiology, and exposure science; and
• Standards development and managing a community-driven process for developing and implementing data standards for high-dimensional scientific data (e.g. exposure ontology).

Budget (Data Science Resource)

Applicants must provide a detailed budget, including justification for all expenditures, for the Data Science Resource component.

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.

Applicants should include resources in the budget to ensure an orderly transition of the data repository at the end of the program period.

PHS 398 Research Plan (Data Science Resource)

Specific Aims: This Resource supports the development and/or implementation and dissemination of robust data and metadata standards to facilitate data and knowledge integration across children s health studies. Applicants should outline specific aims to address these goals.

Research Strategy: Applicants must describe how the central objectives of the Data Science Resource will be accomplished as outlined in the proposed specific aims for this resource. Address the following key functions of the Resource:

• Immediate, efficient, iterative process for identifying existing data and metadata standards most appropriate for data being generated through the CHEAR analytic laboratories and a robust means for implementing those standards in a timeframe that aligns with the initial establishment of the data generation and submission pipeline and continues over the course of the award;
• Near term plan for cataloging CHEAR-relevant data and metadata standards, collecting feedback on those standards and providing/developing scientist-friendly tools to support discoverability and use of standards to assist in linking CHEAR data with other data and knowledge sources (e.g., Comparative Toxicogenomics Database, dbGAP, ENCODE, GEO, Common Fund Metabolomics, CIDR, RoadMap Epigenomics Mapping Centers); and
• Longer term process for identifying and prioritizing data and metadata standard gaps in the environmental exposure domain(s) represented and/or relevant to CHEAR studies and leading and providing direct support for a community-based effort to develop/extend, implement, disseminate and evaluate data and metadata standards that address those gaps.

To accomplish these key functions address the following:

• Overall framework for accomplishing immediate and longer term goals, including relationships/dependencies among different data standard activities and plans for robust coordination of data standard activities with other CHEAR components;
• Plans for working with the Laboratory Network and the Data Repository and Management Core to identify and implement the most appropriate sets of data/metadata standards that capture the full range of data types being generated by or integrated with CHEAR data;
• Methods for version control and dependency tracking for data/metadata standards applied to CHEAR data and the ability to attribute the data standards contributions to the developers;
• Approach for disseminating, tracking use, and soliciting community feedback on data standards and associated tools (e.g., web-based standards catalogue);
• Plans to develop and make available specific tools such as semantic mapping, semantically-enabled federated searching and visualization tools to support data integration with CHEAR deposited-data and other databases and/or resources;
• Ability to lead a community of stakeholders with expertise appropriate for data standards development (e.g., ontologists, bioinformaticians, domain experts, technical developers) in the process of developing/adapting and implementing data/metadata standards for exposures, including approaches to:
  • survey the landscape of existing data standards in the environmental domain to identify gaps or potential overlaps in standards, standards currently in development (e.g. ExO), and opportunities to build on current efforts;
  • identify and prioritize use cases around practical data issues of immediate relevance to CHEAR to address gaps in data/metadata standards; and
  • manage an iterative process of accessing, extending, developing, testing, and implementing data standards based on the use cases;
• Strategies and/or principles for designing the data science tools and resources in such a way to maximize sustainable functioning in the future, even under limited or no funding; and
• Timeline of proposed activities and milestones to assess progress

Note: primary data collection to support collaborative research or methods development projects is beyond the scope of this FOA.

As part of this section, the applicant should also address plans for the following:

How the proposed Data Center will integrate the diverse expertise of the applicant team to meet the goals of the Resource.

Operations management, including:

• Ability to ensure efficient and effective day-to-day administrative operations of the Data Science Resource;
• Capacity to manage several parallel and inter related data support projects and prioritize competing needs; and
• Coordination with other components of the Data Center Resource.

Customer support capacity that may include the following:

• Basic technical support for Investigators participating in CHEAR;
• Communication channels (phone, email, web-based content such as frequently asked questions, and other appropriate mechanisms);
• Ability to refer to more technical staff for issues requiring more detailed knowledge of programming, databases, data federation;
• Ability to refer to staff with in-depth scientific expertise to provide guidance for data/metadata standardization; and
• Description of server maintenance, software maintenance and upgrades, and security and backup processes.

Anticipated challenges/obstacles and alternative strategies to surmount potential obstacles.

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

• Generally, Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and GWAS Sharing Plan) are expected, but they are not applicable to this 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 (Data Science Resource)

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 (Data Science Resource)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in 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: http://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. 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.

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.

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

In order to expedite review, applicants are requested to notify the NIEHS Referral Office by email 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 are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

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 Center 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 Center 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 Center that by its nature is not innovative may be essential to advance a field.

Is the proposed Data Center needed to achieve the goals of the external research community it proposes to serve? Will services offered facilitate or expedite research that would be delayed or infeasible if conducted as independent projects? What advantages will the Center bring to the research community for the storage, maintenance, analysis, interpretation, curation, and integration of data generated by the CHEAR Program? Are the plans for strategic oversight and coordination of effort among other components in the CHEAR Program appropriate?

Has the Center demonstrated its ability to provide adequate support for the storage, maintenance, analysis, interpretation, curation, and integration of data generated by the CHEAR Program?

Are the PD(s)/PI(s) and other personnel well suited to their roles in the Data Center? Do they have appropriate experience and training, and have they demonstrated an ongoing record of excellence in managing community-wide research projects? If the Center is collaborative or multi-PD/PI, do the investigators have complementary and integrated skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the Center described and sufficient to contribute to the likelihood of success of the Center?

Does the application propose novel organizational concepts, management strategies, or services in support of the extramural children's health research community? Are the concepts, strategies, or methods novel to children's health research or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts, management strategies or instrumentation proposed?

Are the overall design, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research community the Data Center will serve? Are potential problems, alternative strategies, and benchmarks for success presented? If the Center is in the early stages of operation, will the strategy establish feasibility and will particularly risky aspects be managed? Are the plans for sharing of exposure data adequate to the needs of the investigators utilizing CHEAR and to the larger research community while maintaining appropriate protection for privacy?

Will the institutional environment in which the Data Center will operate contribute to the probability of success in facilitating the research community it serves? Are the institutional support, equipment, and other physical resources available to the investigators adequate for the Center proposed? Will the Center benefit from unique features of the institutional environment, infrastructure, or personnel?

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

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

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

Not Applicable

Not Applicable

Not Applicable

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

Not Applicable

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

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

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

Reviewers will provide an overall score for the Administrative Core to reflect its likelihood for exerting a sustained, powerful influence on the field(s) involved. The consideration of the following review criteria should also be included. Individual criterion scores will not be assigned.

Review Criteria - Administrative Core

Has the applicant provided a well-reasoned and appropriate strategy for managing and coordinating the Center's activities and providing administrative support for both the Data Repository and Management Core and Research Resource activities?

Is there a well-reasoned plan for the Administrative Core to facilitate interaction between the Data Center and the other components of CHEAR (i.e., the CHEAR Coordinating Center and CHEAR National Exposure Assessment Laboratory Network)?

Does the Administrative Core describe a plan to oversee improvements in CHEAR infrastructure; including the incorporation of methods developed within the Laboratory Network Hubs into other CHEAR activities?

Does the Administrative Core provide a plan to participate in dissemination and outreach activities to promote use of CHEAR to the scientific community?

Is an appropriate plan described to ensure training of CHEAR personnel as needed for standardization of collaborative protocols across components?

Are the Center PD/PI (Core Lead) and other leadership and staff qualified to effectively manage the Center? Have the Director(s) demonstrated an ongoing record of accomplishments related to the objectives of the Core?

Is the percent effort of the Director adequate?

Reviewers will provide an overall score for the Data Repository and Management Core to reflect its likelihood for exerting a sustained, powerful influence on the field. The consideration of the following review criteria should also be included. Individual criterion scores will not be assigned.

Review Criteria - Data Repository and Management Core

Are the Director of the Data Repository and Management Core and other Core staff well suited for the core? Have the core directors demonstrated an ongoing record of accomplishments related to the objectives of the core?

Does the Data Repository and Management Core propose novel strategies to enhance the ability for collection, curation, display, storage, retrieval, integration, interoperability, and reuse of data produced by the CHEAR laboratory components?

Has the applicant provided a well-reasoned and appropriate strategy for establishing and maintaining a data repository and data management infrastructure for CHEAR? Are the proposed approaches user-friendly and likely to facilitate researchers' data access in support of analyses conducted within the CHEAR network? Are potential problems, alternative strategies, and benchmarks for success presented?

Are plans for collaborating with the CHEAR Laboratory Network for implementing and monitoring quality control and data standards adequate?

Are plans for establishing data and software sharing policies and procedures adequate? Do they appropriately account for the need to balance study participant privacy and confidentially with the overall goal of easy access and broad sharing of CHEAR generated data?

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 Data Repository and Management Core benefit from unique features of the scientific environment or collaborative arrangements?

Reviewers will provide an overall score for the Statistical Services and Methods Development Resource to reflect its likelihood for exerting a sustained, powerful influence on the field(s) involved. The consideration of the following review criteria should also be included. Individual criterion scores will not be assigned.

Review Criteria - Statistical Services and Methods Development Resource

Does the Director of the Statistical Services and Methods Development Resource and other Resource staff cover the relevant expertise needed to achieve goals of the Resource, including expertise in statistics, exposure science, epidemiology, bioinformatics, and computational biology?

Does the application propose novel statistical and bioinformatics methodologies or other innovative approaches to analyze data generated by CHEAR and/or address current methodological challenges in children's environmental health research?

Are plans for providing statistical consultation and statistical analysis support to investigators utilizing the CHEAR Laboratory Network resources adequate? Are the collaborative research efforts proposed well-justified and likely to improve understanding of the influence of environmental factors on children's health? Are plans for developing and disseminating new statistical methods and informatics tools adequate and likely to promote easy access and broad sharing of CHEAR generated data?

Are potential problems, alternative strategies, and benchmarks for success presented?

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?

Has the applicant described unique approaches and/or scientific environment to facilitate collaborative projects?

Reviewers will provide an overall score for the Data Science Resource to reflect its likelihood for exerting a sustained, powerful influence on the field(s) involved. The consideration of the following review criteria should also be included. Individual criterion scores will not be assigned

Review Criteria - Data Science Resource

Does the Director of the Data Science Resource and other Resource staff cover relevant expertise (e.g., technical development of biomedical vocabulary/ontology data standards; managing a community-driven standards development process) needed to achieve goals of the Data Science Resource?

Are plans for identifying and implementing data and metadata standards adequate? Are they designed to allow input from other CHEAR components as well as other appropriate members of the broader scientific community?

Are the proposed interfaces/tools to be developed likely to facilitate access to information on data and metadata standards?

Will tools developed support interoperability with deposited data and other databases?

Are potential problems, alternative strategies, and benchmarks for success presented?

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 or collaborative arrangements?

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

As part of the scientific peer review, all applications:

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

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

Applications will be assigned 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 Environmental Health Sciences Council. 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.

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 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.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 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 (or multiple PDs/PIs, if applicable) will have primary authority and responsibility to define objectives and approaches, and to plan, conduct, analyze, and report back results, interpretations, and conclusions of projects conducted. The PD/PI assumes responsibility and accountability to the applicant organization officials and to the NIH for the performance and proper conduct of the CHEAR component in accordance with terms and conditions of the award.

All PD(s)/PI(s) of CHEAR components (Laboratory Network, Data and Statistical Analysis Resource, and Coordinating Center) will have the primary responsibility for:

• Defining objectives and approaches for CHEAR and its components;
• Overseeing the planning, budgeting and conducting of all CHEAR scientific, organizational, and administrative activities specific to the PD(s)/PI(s) s specific award as well as sharing information with other CHEAR awardees to facilitate such activities among the other CHEAR components;
• Promoting, coordinating, and participating in scientific collaborations and approaches across CHEAR components;
• Promoting, coordinating or participating in collaborations between CHEAR and external investigators, including active participation in consultations, data sharing and collaborative research projects with investigators using the CHEAR infrastructure;
• Overseeing or participating in the training of external investigators using CHEAR (including prospective users);
• Establishing agreements amongst themselves and NIH staff that address the following issues: (1) Providing goals and estimated costs for procedures and protocols; (2) Policy and procedures for transferring data among CHEAR components and external investigators; (3) Establishing and adhering to data and metadata standards and sharing data, protocols and other research resources generated by CHEAR components; (4) Procedures for safeguarding confidential information, including data generated by CHEAR components as well as information and/or data received from external investigators; (5) Policy and procedures for addressing ownership of intellectual property that result from aggregate multi-party data; and (6) Policy and procedures for reviewing publications, determining authorship
• Ensuring training of CHEAR personnel as needed for standardization of collaborative protocols across components and for accurate and timely data entry. Participating in quality evaluations including round-robin assessments.
• Overseeing improvements in CHEAR infrastructure; including the incorporation of methods developed within the Laboratory Network Hubs into other CHEAR activities.
• Ensuring adherence to the approved plans for timely sharing of resources and data amongst CHEAR components as well as with external investigators using the CHEAR infrastructure;
• Overseeing or participating in dissemination and outreach activities to promote use of CHEAR to the scientific community;
• Facilitating the formation of and participating in appropriate Working Groups, such as but not limited to exchange of protocols, emerging technologies, data standards, QA/QC;
• Participating as voting member(s) in the activities of the CHEAR Steering Committee and interacting with any sub-committee(s);
• Complying with Coordinating Center requests, as directed by NIH Program Staff and the Steering Committee, to facilitate monitoring of CHEAR progress.
• Attending and participating in the annual PD/PI scientific meetings, and regular committee calls organized by the CHEAR Coordination Center, as relevant
• Accepting and implementing all scientific, organizational, administrative, and policy recommendations approved by the CHEAR Steering Committee to the extent consistent with applicable grant regulations;
• Cooperating in the program evaluation process and interacting with NIH representatives coordinating this process;
• Overseeing the timely preparation and submission to the NIH of progress reports and other information as needed;
• Conducting periodic self-evaluation of the resource; and
• Being prepared for administrative site visits by NIH staff members.

The PD/PI responsible for the CHEAR Coordinating Center will have the following additional responsibilities:

• Organizing the development of CHEAR Steering Committee and other CHEAR sub-committees;
• Organizing and providing logistical support for Steering Committee, Working Groups and other sub-committees;
• Budgeting for, organizing, and providing logistical support for the annual CHEAR Scientific Meeting and annual in-person Steering Committee meeting;
• Identifying, collecting, and managing relevant protocols, data, and other resources used by the CHEAR components;
• Overseeing a Pilot and Feasibility program, with significant input from NIH Program Staff and the CHEAR Steering Committee, to support new emerging technologies or pilot data collection; and
• Serving as the executive secretary for the Steering Committee, which at a minimum includes compiling monthly minutes and quarterly summaries.

Intellectual Property Considerations:

Awardees will be responsible for relevant intellectual property oversight that will include:

• Ensuring the ability to maintain, manage, modify, and distribute items and instruments by securing appropriate permissions from other parties involved;
• Ensuring that infrastructure, items, and instruments developed with NIH grant support are made available to users in a manner consistent with NIH sharing policies (see http://sharing.nih.gov), including the NIH research systems policy and the NIH data sharing policy as applicable;
• Ensuring that agreements with any party, including users, do not unreasonably limit access by other parties to the CHEAR infrastructure and/or items or instruments; and
• Establishing appropriate agreements between/among stakeholders for the appropriate sharing of data and appropriate protection of intellectual property.
• The PD(s)/PI(s) assumes responsibility and accountability to the applicant organization officials and to the NIH for the performance and proper conduct of research conducted with or through CHEAR in accordance with terms and conditions of the award.

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

One or more designated NIH staff, acting as Project Scientist(s), will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards. If more than one Project Scientist is identified on any CHEAR component, one will be assigned as the Lead Project Scientist. The NIH Project Scientist(s) and other substantially involved NIH program staff members will assist CHEAR by:

• Monitoring the operations of CHEAR components and activities;
• Evaluating the progress and compliance of CHEAR with the operating policies of the Steering Committee;
• Attending and participating in all Steering Committee and subcommittee meetings of the CHEAR program;
• Along with the Coordinating Center, organizing and coordinating annual CHEAR Scientific meeting;
• Participating in the CHEAR evaluation activities, including coordination of an external evaluation of the CHEAR Program;
• Evaluating the adherence of CHEAR awardees to any approved data sharing plans or intellectual property plans;
• Serving as a liaison between the Steering Committee, CHEAR, NIH and other federal or international agencies as needed;
• Making recommendations to the CHEAR Steering Committee on strategic directions and improvements to CHEAR components and activities;
• Serving as a liaison to facilitate and/or coordinate interactions between CHEAR and other entities that may be mutually beneficial;
• Using the NIH channels to disseminate knowledge about the CHEAR to scientific community and other stakeholders as needed; and
• Facilitating contacts between CHEAR and non-CHEAR-affiliated researchers interested in potential collaborations with the CHEAR and/or the use of the CHEAR as a resource.

NIH staff members who are substantially involved in the scientific activities (e.g., publications) of the CHEAR will not attend peer review meetings of renewal and/or supplemental applications.

In addition, an NIH Program Director acting as the Program Official will be responsible for the normal scientific and programmatic stewardship of the award, and will be named in the award notice. If this individual becomes substantially involved in the CHEAR activities, he/she will not attend peer review meetings of renewal and/or supplemental applications or will seek NIH waiver if such participation is essential.

The NIH reserves the right to adjust funding, withhold, suspend, or terminate the support to the CHEAR awardee and/or member institutions that are unable to meet the performance requirements set forth in these Terms and Conditions of Award, or significantly change the level of performance.

Areas of Joint Responsibility include:

CHEAR Steering Committee. The CHEAR Steering Committee will serve as the main governing board for the CHEAR Program. The Steering Committee will consist of the following voting members:

• CHEAR PD(s)/PI(s) one of whom is expected to chair the Steering Committee;
• Up to two additional designees from each CHEAR component; and
• The NIH Program Officer(s) and Lead Project Scientists for each CHEAR Component.

NOTE: Each voting member noted above representing CHEAR will have one vote (including those individuals who may have multiple responsibilities).

All NIH representatives will collectively have one vote.

The PD/PI of the Coordinating Center will serve as Steering Committee Chair the first year of the program; thereafter, a Steering Committee Chair will be elected every twelve months from amongst the Steering Committee members by the committee. An individual may continue serving as Chair for more than one year if all committee members agree. NIH staff cannot serve as Steering Committee Chair.

In the event that the Steering Committee cannot agree on critical aspects, such as common protocols, then NIH Staff will have final authority to implement proposed recommendations. All activities must comply with NIH, DHHS, and Federal Guidelines.

Additional individuals may be added to the CHEAR Steering Committee as non-voting members by a decision of the existing voting members. These additional non-voting members may include, for example, other NIH Program Staff members, and/or Program Staff members from other Federal Agencies (e.g., Centers for Disease Control and Prevention, U.S. Food and Drug Administration). PD(s)/PI(s) of projects using the CHEAR infrastructure may also be invited when their presence is needed.

Other guidelines for the Steering Committee, such as a quorum, frequency, duration, and type of meetings (in-person, remote), will be determined at its initial meeting.

The CHEAR Steering Committee will meet twice per year in person and monthly via phone conference. Applicants should budget for in-person meetings. The first meeting will occur in Research Triangle Park, NC. Subsequent meetings will be held at CHEAR awardee locations to be determined.

The CHEAR Steering Committee will have primary responsibility for:

• Overseeing the overall functioning of the CHEAR;
• Reviewing CHEAR strategic goals for its evolution as a research resource (in consultation with Scientific Consulting Panel, see below);
• Sharing progress among the components of the CHEAR; and
• Ensuring that the CHEAR takes advantage of existing NIH resources and programs.

The CHEAR Steering Committee may also form subcommittees, each with a specific functional area of oversight as defined in the application.

Scientific Consulting Panel. A Scientific Consulting Panel will operate as an evaluative subcommittee to the NIH, advising NIH and providing technical expertise to the entire CHEAR. This panel will comprise scientific experts not affiliated with the CHEAR institutions and may include scientists from academic and other research institutions as well as from NIH, other Federal Agencies, pediatricians and clinical staff, and relevant stakeholders. Members of the Scientific Consulting Panel will be selected by the NIH in consultation with the CHEAR Steering Committee. The Scientific Consulting Panel will be charged with the following activities:

• Reviewing the overall progress of the CHEAR and making appropriate recommendations to strengthen activities in certain areas as requested by NIH Staff;
• Participating in the semi-annual CHEAR Scientific Meetings;
• Providing additional consultations to the Steering Committee NIH staff as needed (responding to inquiries via e-mail and/or telephone); and
• Providing linkages to investigators not funded by CHEAR but conducting, or interested in providing related services.

Dispute Resolution:

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

Progress reports for multi-year funded awards are due annually on or before the anniversary of the budget/project period start date of award. The reporting period for multi-year funded award progress report is the calendar year preceding the anniversary date of the award. Information on the content of the progress report and instructions on how to submit the report are posted at http://grants.nih.gov/grants/policy/myf.htm. In addition, this program will require interim progress reports to be filed semi-annually and reporting on activities in the preceding six month period.

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.

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Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-710-0267

David M. Balshaw, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-2448
Email: [email protected]

Claudia Thompson, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-4638
Email: [email protected]

Alfonso Latoni, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-7571
Email: [email protected]

Linda Bass, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-1307
Email: [email protected]

Leroy Worth, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-0670
Email: [email protected]

George Tucker
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-2749
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 75.