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

In order to fully understand children's health (i.e., from pre-conception through age 21) researchers must consider both environmental and genetic factors. Many studies conducted in the past, or in the field today, have not been designed to consider the full array of environmental exposures that may affect a child's health and wellbeing. The National Institute of Environmental Health Sciences (NIEHS) intends to promote the characterization of the exposome ( as originally defined by Christopher Wild in his 2005 Cancer Epidemiology, Biomarkers, and Prevention paper as the totality of environmental exposures from conception through development, including chemical, physical and biological stressors as well as lifestyle and social environments) in studies of children's health through the establishment of an infrastructure to enable the measurement and integration of environmental exposures. NIEHS is publishing three distinct but integrated Funding Opportunity Announcements (FOAs) that solicit a coordinated network of laboratories and statistical and data science resources to provide access to comprehensive exposure analysis that can be performed using biological samples collected in studies of children's health. This resource will be known as the Children's Health Exposure Analysis Resource (CHEAR).

CHEAR will continue the original intent of the National Children's Study to advance our understanding of the impact of environmental exposures on children's health and development. It will provide access to infrastructure for adding comprehensive exposure analysis of biological samples to existing epidemiological and clinical studies involving research in children's health. CHEAR will provide a range of services including:

• expert consultation on exposure analysis, study design, and data analysis and interpretation;
• analysis of samples using state-of-the-art methods and technologies;
• a data repository and associated data science tools;
• statistical and data analytical services including support for meta analyses;
• development and dissemination of new statistical methods and informatics tools; and
• support for pilot and feasibility studies.

The standardized laboratory analysis of samples and data and the central data repository will enable the integration of complex exposure data across multiple studies to enhance the opportunity for data pooling or comparative analyses. In many situations this will provide the otherwise unattainable power to statistically analyze the combined contributions of multiple environmental and genetic factors as determinants of children's health across a range of diseases and disorders. Furthermore, CHEAR will develop and promote data standards and common data elements (e.g., ontologies, annotation, and metadata) within the research community to facilitate inclusion of exposure analysis in children's health research.

Exposures measured by CHEAR will encompass the breadth of the exposome, the totality of biological, psycho-social, chemical, and physical exposures through the use of both comprehensive targeted and non-targeted methods of analysis. This definition of the environment goes significantly beyond the traditional definition applied to most NIEHS programs and includes exposures associated with lifestyle and the social environment to the extent that they can be measured within the infrastructure provided by CHEAR. The program will also include the characterization of associated biological response indicators to provide additional information on exposures and the impact of exposures on key biological pathways relevant for children's development. The comprehensive approach that CHEAR offers to the children's health community will enable communication among investigators leading epidemiological or clinical studies of children's health; promote collaborative research projects; leverage new data on environmental exposures for discovery of new hypotheses and associations; and identify common challenges in research on children's health and search for solutions.

CHEAR is comprised of three units:

• A network of laboratories providing access to state-of-the-art infrastructure for both targeted and untargeted analysis of biological samples as well as characterization of biological responses associated with those exposures (henceforth referred to as the CHEAR National Exposure Assessment Laboratory Network (Lab Network or Hubs); to be supported under RFA-ES-15-009).
• A data and analytics support resource providing a repository for all data and support for statistical analysis and interpretation. This resource will also lead the development of community based of data standards and support the development of ontologies and metadata standards (henceforth referred to as the CHEAR Data Repository, Analysis and Science Center (Data Center); to be supported under RFA-ES-15-010).
• A coordinating Center providing administrative management of the resource including an interface to the research community and an index of additional exposure analysis tools not included within the CHEAR infrastructure (henceforth referred to as the CHEAR Coordinating Center (CC); to be supported under RFA-ES-15-011).

CHEAR will provide these services to the children's health research community. The intent of the program is broad, and will cover a range of epidemiological or clinical study designs. The user community that we would expect to take advantage of this Resource could include researchers conducting children's studies that have a rich characterization of environmental exposures but which could benefit from a more extensive, exposome scale analysis, such as, but not limited to, the NIEHS and Environmental Protection Agency funded Centers for Children's Environmental Health & Disease Prevention Research (http://www.niehs.nih.gov/research/supported/dert/programs/prevention/). Conversely, studies could include projects that currently have little characterization of exposures such as Project VIVA (https://www.hms.harvard.edu/viva/index.html).

The main access to the resource will be through the Coordinating Center which will coordinate consulting services in support of study design and analysis, as well as develop and oversee a proposal process which will evaluate projects based on criteria such as the plans for incorporating or expanding exposure analysis, availability of expertise and capacity within CHEAR, and the likelihood of a high impact scientific contribution.

There is a rich and growing body of literature arising from the children's environmental health research community demonstrating that consequences of environmental exposures during critical periods in development can manifest as disease or dysfunction at any point across the human life span from infancy to old age. Children have increased risks from environmental exposures, including nutrition, stress, drugs, and environmental pollutants because their major organ systems cardiovascular, digestive, immune, nervous, and others are developing from the time of conception through adolescence. Traditionally, studies of the environmental influences on children's health and development have focused primarily on one-to-one relationships between environmental exposures and health related endpoints. Environmental health effects are complex and not a simple, one-to-one, relationship between a particular type and amount of exposure and disease. There are complicated interactions between the environment, genetics, and other factors and these interactions may affect children's health. The concept of the exposome (http://www.niehs.nih.gov/research/supported/dert/programs/exposure/) seeks to compliment traditional epidemiological approaches with an effort to integrate information on exposures to multiple (ideally all) stressors across many scales of variation (time, space, route of exposure, and biological context) and apply that global perspective on exposure to the data driven discovery of novel associations for further hypothesis driven research.

The NIH investment in children's health is significant, with a large number of important children's health studies having extensive data on clinical, biological, and genetic contributions to disease but lacking the comprehensive exposure analysis that CHEAR would provide. Similarly, there are many children's health studies already having well characterized information on a limited number of exposures which would, nonetheless, benefit from a significantly expanded exposure analysis.

Therefore, there is a need for the establishment of a focused infrastructure for comprehensive exposure analysis of biological samples to provide (1) rigorous assessment of a range of environmental exposures, xenobiotics, physiological measurements, and other biological indicators of environmental exposure and response and (2) statistical tools and data science approaches to manage and analyze all of these newly generated datasets in a cohesive and integrated manner. CHEAR will enable the children's health research community to enhance and build on their existing studies by expanding the capability or capacity of measuring both chemical and non-chemical stressors that effect children's wellbeing and development. It is expected that by implementing standard measures and analyses across studies and encouraging collaborations and networking, CHEAR will enable meta-analyses and integration of datasets of multiple cohorts and other study designs.

Other NIH resources such as the Center for Inherited Disease Research (CIDR, http://www.cidr.jhmi.edu/) have provided an opportunity to greatly expand our understanding of the genetic contributions to human disease. The CHEAR infrastructure will establish an environmental counterpart to CIDR and will enable studies to interrogate the combined effects of genes and environment in children's health. Researchers wishing to access the services must submit proposals to the CHEAR Coordinating Center for review and consideration. Analytical services will be provided to approved projects without charge to NIH funded (extramural) projects; NIH intramural projects and those not supported by NIH may access the resource through a cost-recovery effort provided analytical capacity is available.

This FOA will support the creation the CHEAR National Exposure Assessment Laboratory Network, a network of laboratory Hubs, supporting comprehensive analytical services to extend or complement the objectives of children's health studies to measure environmental exposures. The main emphasis for these Hubs is to provide capacity for targeted analyses using state-of-the-art assays specific to known compounds or stressors, such as the methods used by the CDC National Biomonitoring Program (http://www.cdc.gov/nchs/data/nhanes/nhanes_13_14/2013_MEC_Laboratory_Procedures_Manual.pdf). These Hubs will also advance the concept of the exposome by providing a comprehensive assessment of both endogenous and exogenous compounds through the application of untargeted metabolomics approaches, i.e., assessing the global complement of small molecules simultaneously. Hubs will also provide measurements of individual biological responses to provide a biological anchor for these environmental stressors. In addition, each Hub will support a Developmental Core to expand the capabilities of CHEAR by developing and validating new exposure and response measures and to investigate the use of a range of accessible biological samples for children's health studies.

Targeted Analysis is a resource that will include state-of-the-art biomonitoring of specific analytes (or classes), both endogenous and exogenous, known or suspected to affect or modify risk for health outcomes in children. Clinical Laboratory Improvement Amendments (CLIA, https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/index.html?redirect=/clia) certification is not required but may be beneficial in supporting clinical applications of children's health data.

These targeted approaches can include but are not limited to:

• Measurement in biological fluids of environmental chemical and physical exposures known to affect children's health including (but not limited to) polyaromatic hydrocarbons, fluorinated compounds, flame retardants, organophosphate insecticides and pesticides, endocrine disrupting chemicals, phthalates, toxic metals, and;
• Measurement of markers of psycho-social stress (e.g., cortisol and lipid profiles);
• Measurement of chemicals associated with lifestyle choices such as tobacco smoke or substances of abuse;
• Measurement of endogenous compounds including hormone panels (e.g., estradiol/estrogen, androgen, testosterone, thyroid panels, triglycerides, cholesterol, and insulin), measures of oxidative stress (e.g., isoprostanes, IL-10), and immune indicators (Treg cell function, TH1, TH2, and interleukins);
• Measurement of nutritional indicators including micronutrients (e.g., selenium, zinc, water-soluble and fat-soluble vitamins, iron, ferritin, and total-iron-binding capacity) and other dietary factors, (e.g., isoflavones, phytoestrogens, folate, homocysteine, mycotoxins and nitrosamines); and
• Analysis will be conducted on a variety of specimen types such as serum, plasma, cord blood, urine, placenta, saliva, teeth, hair, nails or others.

Laboratory capabilities needed to accomplish these goals include, at a minimum, the following:

• The targeted analysis of environmental exposures with appropriate sensitivity and specificity, as well as state-of-the-art sample collection and processing protocols;
• Comprehensive sample tracking system;
• Quality Assurance/quality control methods;
• Standardized measurements and reporting;
• Developing methods for targeted analysis of emerging compounds of interest; and
• Ability to acquire additional, specialized expertise through subcontracts with other labs.

Untargeted Analysis, the second required resource, will complement targeted analysis of specific compounds with the measurement of large sets of analytes (hundreds to thousands) simultaneously in a manner to allow the hypothesis-free (data-driven or 'agnostic') association between exposure and biological response. It is an expectation, although not a requirement, that all samples submitted for targeted analysis will also be analyzed with untargeted methodologies. Researchers utilizing the CHEAR Lab Network services may also request untargeted analysis without utilizing the targeted analysis services. Activities associated with this resource can include, but are not limited to:

• Mass spectrometry and NMR-based, where appropriate, global analyses of biological samples from ongoing studies
• Comparative analysis of spectra stratified by available supporting information such as high and low exposure groups, case-control studies, or extremes in phenotypic or clinical measures;
• Development of strategies for identifying peaks of interest, including MSn, and compound and standard synthesis (which can be supported by the Common Fund Metabolomics Program Synthesis Core, http://www.metabolomicsworkbench.org/standards/nominatecompounds.php) for identifying and validating MS peaks; and
• Identification of significant peaks (or unique chemical entities - UCEs) found in multiple metabolomics studies through database searches (e.g., Metlin or the Human Metabolomics Database) for subsequent methods development and validation efforts.

Biological Response Indicators, the third required resource, will measure integrated, functional measures of individual response to environmental stressors, using established markers. Approaches may include, but are not limited to:

• State-of-the-art measurements for well-validated intermediate phenotypes or markers, including but not limited to reactive oxygen species, oxidized or adducted proteins or DNA;
• Measures of immune activation/inflammation;
• Measures of response to psycho-social stress;
• Functional Assays including DNA damage response and repair capacity; and
• Molecular analyses including epigenetics, miRNA and mRNA in whole blood, individual cell types, serum, or exosomes.

Developmental Core: This activity will expand the research capacity of the Hub by developing and validating new methods for future analytic services (note that these are examples and are not required). Examples of the types of activities that might be performed include:

• Targeted detection and quantification of emerging environmental stressors of interest including hits from untargeted analyses;
• Adapting measures used in general population studies to children's health studies;
• Developing novel approaches for detecting analytes in easily accessible tissues in addition to serum, plasma, cord blood, and urine;
• Developing approaches for in utero or pre-conception measures (e.g., follicular fluid, semen, vaginal swabs);
• Further development and testing of functional measures including DNA repair capacity, redox status, novel measures of inflammation; and
• Developmental activities to maximize analysis of low-abundance exogenous analytes (removing high abundance nutrition or endogenous metabolites).

Administrative Core: Each Hub will have an Administrative Core that will coordinate all activities with the analytical Hub including:

• Advise applicants on sample requirements, sample quality, typical concentration ranges for specific analytes (e.g., from NHANES or published literature). This can include sample collection and storage protocols for maximizing biological information (specifically for ongoing studies), and sample shipping mediated by the Coordinating Center;
• Support analysis and interpretation of Hub generated data in cooperation with the Data Center;
• Outreach to outside laboratories with analytic capabilities/expertise that do not reside in the Hub;
• Integration with Coordinating Center, other Hubs and Data Center;
• Sample tracking; and
• Integration with the Data Center to develop appropriate annotated data set with standardized measures and responses.

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
Telephone: 919-541-0670
Fax: 301-480-3722
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 Developmental Core)	12
Research Resource (Use for the Targeted Analysis Resource, the Untargeted Analysis Resource and the Biological Response Indicators Analysis 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
• Developmental Core: required
• Targeted Analysis Resource: required
• Untargeted Analysis Resource: required
• Biological Response Indicators Analysis 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.

Other Attachments:

The filename provided for the attachment will be the name used for the bookmark in the application image. Other Attachments must not exceed 10 pages. Applications that exceed this limit will be withdrawn.

The following materials are required:

Demonstration for technical and analytical capabilities and expertise (use the file name: "Capabilities") as described below:

• A tabulation of targeted analyte services to be offered including documented limit of detection and estimated sample throughput capacity; and
• Demonstration of past performance of analytical services applied to epidemiological studies through contracts or collaborations, including a description of sample types, sample volumes, and assay development.

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 goals of the proposed Exposure Assessment Laboratory Network Hub including the specific aims of each component resource and the proposed development core.

Research Strategy: Thoroughly address the main objective of the Exposure Assessment Laboratory Network Hub, which is to create a research resource that will provide analytic services and support for measuring exposures and biological responses in studies of children's health.

The application must describe the planned organizational structure under which the Hub proposes to operate. An organizational chart showing how the group will function as a service facility must also be included.

As part of this section, describe the following elements:

Background:

• How the proposed Hub will meet the general program objectives as an analytical resource;
• Referring to Other Attachments as necessary, describe targeted analyte services to be offered ;and
• Referring to Other Attachments as necessary, describe past performance of analytical services applied to epidemiological studies through contracts or collaborations.

Overview of the vision analytical Hub, including:

• Plans for moving towards a more comprehensive capability for measuring a diverse range of exogenous and endogenous exposures in studies of children's health;
• Plans for integrating internal exposure measures with biological response and other phenotypic data; and
• Plans for long-term sustainability of the Analytic Services (outreach, expanding capabilities, methods development and discovery).

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, should include a Data and Resource Sharing Plan addressing the following:

• The CHEAR Program encourages 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 expects 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 expects 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 encourages 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 expected to implement software sharing plans consistent with achieving the goals of this program.

The application is also expected to 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.

• 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 Hub PD/PI must serve as the Administrative Core Lead and should emphasize experience and expertise in coordinating multi-project programs and facilitating research linking exposure science and epidemiology.

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.

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.

The costs associated with the Administrative Core should not exceed 5% of the total Direct Costs of the Hub. The budget for the Administrative Core should include travel for the Hub PD/PI and resource directors and core leads to attend 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 Hub.

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

Overall Hub 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 Research Resource as a whole;

Detailed plans to support the activities of the Hub including at a minimum:

• Teleconferences; Coordination with the Data Center and other Hubs, and Coordinating Center;
• Support for internal evaluation and self-assessment, including:

- Ability to generate Hub progress reports;

- Ability to assess and anticipate researcher needs; and

- Ability to prioritize and incorporate improvements into Hub operations and software that enhance its utility for research. (e.g., sample tracking, work flow etc.).

- Provide coordination of consulting activities on sample requirements and analyses

• Operations management, including:

- Ability to ensure efficient and effective day-to-day administrative operations of the Hub; and

- Coordination with other CHEAR Components (Hubs, Coordinating Center and Data Center) as appropriate for consultative services to assist researchers in obtaining analytical services, standard data reporting, and integration of exposure data with other study outcomes.

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 (Developmental 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 (Developmental Core)

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

Research & Related Other Project Information (Developmental 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) (Developmental 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 (Developmental Core)

• 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 Senior and Key Personnel should emphasize experience and expertise in bioanalytical chemistry and biomonitoring, clinical chemistry, and/or biochemistry, toxicology, exposure science, and biomarker development and testing.

Budget (Developmental Core)

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

The costs associated with the Developmental Core should not exceed 10% of the total Direct Costs of the Hub.

PHS 398 Research Plan (Developmental Core)

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

Research Strategy: The Developmental Core will provide support for developing new methods for exposure assessment in biological samples; develop protocols for measuring new analytes discovered and verified in the Untargeted Analysis Resource; and identify, measure, and validate new biological response indicators that can be adopted by the Biological Response Indicators Resource.

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

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

Applications should describe detailed plans for the proposed Developmental Core which may include:

• Development of new protocols for analysis of compounds of interest, either identified through untargeted analyses or nominated from external sources, for which there are not existing methods;
• Discovery or identification of analytes in a range of biological matrices including less commonly studied samples such as teeth or follicular fluid;
• Development and testing of novel functional measures of biological response;
• Development of new internal measures of diet, exercise, or response to psycho-social stress;
• Development of signatures of oxidant "load", DNA damage response, persistent inflammation, or immune activation; and
• Development of new sample collection and processing methods for maximizing biological information.

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 (Developmental 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 (Developmental 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 (Targeted Analysis 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 (Targeted Analysis Resource)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Targeted Analysis 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) (Targeted Analysis 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 (Targeted Analysis Resource)

• In the Project Director/Principal Investigator section of the form, use Project Role of 'Other' with Category of 'Resource Director' 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 and Key Personnel should emphasize expertise and experience in:

• Bioanalytical chemistry and biomonitoring, clinical chemistry, and/or biochemistry, toxicology, exposure science, and biomarker development and testing in the context of epidemiological studies;
• Sample tracking, workflow, and quality control for analytical services; and
• Data processing needed for interactions with Data Center and with the study investigators.

Budget (Targeted Analysis Resource)

Applicants must provide a detailed budget, including justification for all expenditures, for the Research Resource Component.

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

The costs associated with the Targeted Analysis Research Resource should represent a minimum of 60% of the total Direct Costs of the Hub. These costs include the provision of analytical services at no cost to the external research groups.

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 (Targeted Analysis Resource)

Specific Aims: This Resource will provide the technical infrastructure for targeted analysis of environmental stressors affecting children's health. Applicants should outline specific aims to address these goals.

Research Strategy: This Resource is intended to serve as a resource to the research community by providing scientific and technical expertise to researchers seeking to expand exposure assessment in their research or clinical settings. Applicants must outline the technical functions of the Targeted Analysis Resource. This Resource will be organized around the technical work (analysis methods, protocols, data management and harmonization required to support the exposure assessment networks).

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

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

Customer support capacity that may include the following:

• Basic technical support for new and established users; and
• Communication channels (phone, email, web-based content such as frequently asked questions, and other appropriate mechanisms) for potential and existing users to obtain information on how to optimally use the resource and each measurement system independently or in combination

Applications should describe detailed plans for the proposed Targeted Analysis Resource which may include:

• Discussion of how the Targeted Analysis Resource will use the required Administrative Core for its functions including interactions with the Administrative Core, Untargeted Analysis Resource, Biological Response Indicators Resource, and the Developmental Core, including the coordination of efforts and lines of responsibilities;
• Description of proposed methods for providing sensitive, reproducible, exposure and measures. This may reference the table of targeted analytes and capacity provided in "Other Attachments" of the Overall description;
• Discussion of plans for data processing and analysis;
• Discussion of internal workflow oversight including quality control and analysis; and

Description of plans for harmonization of methods and analyses with other CHEAR Hubs including the potential for Round Robin and Ring Trial assessments.

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 (Targeted Analysis 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 (Targeted Analysis 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 (Untargeted Analysis 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 (Untargeted Analysis Resource)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Untargeted Analysis 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) (Untargeted Analysis 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 (Untargeted Analysis Resource)

• In the Project Director/Principal Investigator section of the form, use Project Role of 'Other' with Category of 'Resource Director' 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 and Key Personnel should emphasize experience and expertise in:

• Untargeted metabolomics for epidemiological studies including sample preparation and analysis as well as data processing and interpretation;
• Synthetic chemistry and identification of unknown compounds through MS and NMR techniques;
• Data processing; and
• Sample tracking, workflow, and quality control for analytical services.

Budget (Untargeted Analysis Resource)

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

The costs associated with the Biological Response Indicators Resource should represent 10-15% of the total Direct Costs of the Hub. These costs include the provision of analytical services at no cost to the external research groups.

PHS 398 Research Plan (Untargeted Analysis Resource)

Specific Aims: This Resource will provide the technical infrastructure for measuring biological response indicators, including validated functional assays. Applicants should outline specific aims to address these goals.

Research Strategy: This Resource is intended to serve the research community by providing scientific and technical expertise to researchers seeking to link biological response measures to exposure assessment for more comprehensive characterization of exposures and responses that contribute to health outcomes in children. Applicants must outline the technical functions of the Biological Response Indicators Resource. This Resource will be organized around the technical work (analysis methods, protocols, data management and harmonization required to support the exposure assessment networks).

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

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

Applications should describe detailed plans for the proposed Biological Response Indicators Resource which may include:

• Discussion of how the Untargeted Analysis Resource will use the required Administrative Core for its functions including interactions with the Administrative Core, Targeted Analysis Resource, Biological Response Indicators Resource, and the Developmental Core, including the coordination of efforts and lines of responsibilities;
• Description of plans to support the discovery and optimization of novel peaks;
• Discussion of plans for data processing and analysis; and
• Discussion of internal workflow oversight including quality control and analysis.

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 (Untargeted Analysis 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 (Untargeted Analysis 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 (Biological Response Indicators Resource)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant's Project - enter "Research Resource Functionality"
• Proposed Project Start/Ending Dates - enter the same dates as the proposed project period for the entire application

PHS 398 Cover Page Supplement (Biological Response Indicators Resource)

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

Research & Related Other Project Information (Biological Response Indicators 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) (Biological Response Indicators 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 (Biological Response Indicators Resource)

• In the Project Director/Principal Investigator section of the form, use Project Role of 'Other' with Category of 'Resource Director' 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 and Key Personnel should emphasize experience and expertise in:

• Toxicology, molecular biology, exposure science;
• Methods for measuring response markers in stored biological samples;
• Developing, optimizing, and applying biomarker measures or functional assays for children's health;
• Data processing; and
• Sample tracking, workflow, and quality control for analytical services.

Budget (Biological Response Indicators Resource)

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

The costs associated with the Biological Response Indicators Resource should represent 10-15% of the total Direct Costs of the Hub. These costs include the provision of analytical services at no cost to the external research groups.

PHS 398 Research Plan (Biological Response Indicators Resource)

Specific Aims: This Resource will provide the technical infrastructure for measuring biological response indicators, including validated functional assays. Applicants should outline specific aims to address these goals.

Research Strategy: This Resource is intended to serve the research community by providing scientific and technical expertise to researchers seeking to link biological response measures to exposure assessment for more comprehensive characterization of exposures and responses that contribute to health outcomes in children. Applicants must outline the technical functions of the Biological Response Indicators Resource. This Resource will be organized around the technical work (analysis methods, protocols, data management and harmonization required to support the exposure assessment networks).

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

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

Customer support capacity that may include the following:

• Basic technical support for new and established users; and
• Communication channels (phone, email, web-based content such as frequently asked questions, and other appropriate mechanisms) for potential and existing users to obtain information on how to optimally use the resource and each measurement system independently or in combination

Applications should describe detailed plans for the proposed Biological Response Indicators Resource which may include:

• Description of proposed methods for providing sensitive, reproducible response measures. This may reference the table of targeted analytes and capacity provided in "Other Attachment" of the Overall description
• Discussion of how the Biological Response Indicators Resource will use the required Administrative Core for its functions including interactions with the Administrative Core, Targeted Analysis Resource, Untargeted Analysis Resource, and the Developmental Core, including the coordination of efforts and lines of responsibilities;
• Discussion of plans for the measurement of biological response indicators and application of functional assays to analyze samples from children's health studies;
• Description of plans to support the discovery and optimization of novel biological response indicators;
• Discussion of plans for data processing and analysis; and
• Discussion of internal workflow oversight including quality control and analysis.

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 (Biological Response Indicators 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 (Biological Response Indicators 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 Hub 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 Hub 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 Hub that by its nature is not innovative may be essential to advance a field.

Is the proposed Hub needed to achieve the goals of the children's health research community it proposes to serve? Will coordinated services offered facilitate or expedite research that would be delayed or infeasible if conducted as independent projects? What advantages will the Hub bring to the research community? Does the proposed plan describe a laboratory Hub that will provide extensive and efficient analytical measures of exposure and response to researchers examining children's health? Are future directions and needs of the research field addressed with appropriate consideration to adapting or modifying new measures of environmental, lifestyle and other non-genetic factors for studies of children's health? Are the plans for the laboratory Hub to move towards a more comprehensive capability for measuring exogenous and endogenous exposures on an exposome scale addressed?

Are the PD(s)/PI(s) and other personnel well suited to their roles in the Hub? Do they have appropriate experience and training, and have they demonstrated an ongoing record of excellence in supporting community-wide research projects? If the Hub 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? Are the investigator's experience and expertise with analytical services, assay development, and processing of relevant biological samples from epidemiological studies appropriate? Is the investigator's experience in developing and validating novel approaches to exposure assessment well documented?

Does the application propose novel organizational concepts, management strategies, or instrumentation in providing services to the children's health research community? Are the concepts, strategies, or instrumentation 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 novel approaches being used by the investigators to adapt or develop new methods for measuring analytes that reflect exposures to environmental and lifestyle factors in children's studies? Does the proposed plan allow for novel, validated methods to be incorporated into the Targeted Analysis Resource during the project period?

Are the overall design, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research community the Hub will serve? Are potential problems, alternative strategies, and benchmarks for success presented? If the Hub is in the early stages of operation, will the strategy establish feasibility and will particularly risky aspects be managed? Does the proposed plan create a sufficiently high likelihood of successful adaptation and scale-up of existing methods for adoption by diverse children's health studies? Will the proposed effort support the integration of targeted and untargeted exposure assessment with biological response indicators?

Will the institutional environment in which the Hub 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 Hub proposed? Will the Hub benefit from unique features of the institutional environment, infrastructure, or personnel? Are the existing instrumentation and expertise adequate for continued support and expansion of the laboratory Hubs? If additional instrumentation dedicated to the project is needed, can this be acquired rapidly and within the budget for immediate use in the laboratory Hub? Are there sufficient commitments of facilities, infrastructure, and other resources to allow for the full-scale operation throughout the project period?

As applicable for the Hub 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 Hub 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 Hub 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, in consideration of the following review criteria. Individual criterion scores will not be assigned.

Reviewers will specifically assess the likelihood that the proposed resources and oversight by this Core will provide and exert a sustained, effective, influence in the field of children's environmental health. Consideration of the following bullets should also be included in the overall assessment:

• Is a well-reasoned and appropriate strategy for managing and coordinating Hub activities and providing administrative support for the activities of the Developmental Core, the Targeted Analysis, Untargeted, and Biological Response Indicators Resources described?
• Has the application provided an appropriate strategy for coordinating activities with the other laboratory Hubs and integration with the Data Center, and Coordinating Center, and for providing technical information to study investigators on sample collection, storage and/or processing information for obtaining maximum information on analytes from biological samples?
• Does the Hub Director demonstrate an ongoing record of accomplishments related to the objectives of the Core?
• Has the Administrative Core provided an appropriate plan for internal evaluation and self-assessment, including: the ability to generate Hub progress reports, the ability to assess and anticipate researcher needs; and the ability to prioritize and incorporate improvements into Hub operations that enhance its utility for providing additional data and analyses for children's health studies?
• Will the Administrative Core benefit from unique features of the scientific or administrative environment or collaborative arrangements?

Reviewers will provide an overall score for the Development Core, in consideration of the following review criteria and additional review criteria. Individual criterion scores will not be assigned.

Reviewers will consider the following in determining overall merit of the Development Core. An application does not need to be strong in all categories to be judged likely to have major scientific impact

• Are the Core Lead and other staff well suited for the Core? Has the Core Lead demonstrated an ongoing record of accomplishments related to the objectives of the core?
• Does the Development Core enhance the ability of the Hub Resources to utilize novel approaches or methodologies to measure analytes or biological markers reflecting environmental exposures or response?
• Does the application provide a well-reasoned and appropriate strategy for increasing the number of analytes and biological markers measured in children's health studies?
• Has the applicant provided a sound strategy for measuring analytes and markers in accessible biological samples from children's studies beyond blood, serum, plasma, or urine?
• Does the Core proposal provide a strategy for testing and verifying new biomarkers of response or assays for functional capacity?
• Are the institutional support, equipment and other physical resources available to the investigators adequate for the Core proposed? Will the Development Core benefit from unique features of the scientific environment or collaborative arrangements with other components of the laboratory Hub?

Reviewers will evaluate the following resource and provide an overall score based on the individual review criteria for each required resource. Individual criterion scores will not be assigned.

Reviewers should consider the individual bulleted elements in their overall assessment in terms of scientific and technical merit, and in providing overall impact score:

• Do the investigators provide needed complementary expertise in mass spectrometry, exposure science, and other analytical methods for targeted analysis?
• Is the existing infrastructure sufficient to support the planned activities or are plans to acquire and install new equipment appropriate?
• Does the research strategy adequately address in sample tracking, workflow, and quality control to provide the required analytical services to study investigators?
• Does the proposed plan for targeted analyte measurements have appropriate breadth, sensitivity and capacity?
• Are data processing and coordination with the Data Center adequate for transferring analytical data to the data repository?
• Are plans for coordination with the other Hubs appropriate?
• Does the Resource Director provide a plan to ensure efficient and effective day-to-day administrative operations of the Targeted Analysis Resource?

Reviewers will evaluate the following resource and provide an overall score based on the individual review criteria for each required resource. Individual criterion scores will not be assigned.

Reviewers should consider the individual bulleted elements in their overall assessment in terms of scientific and technical merit, and in providing overall impact score:

• Do the investigators provide appropriate complementary expertise in metabalomics, exposomics, and other analytical methods for untargeted (global) metabolite analysis for exogenous and endogenous compounds?
• Is the existing infrastructure sufficient to support the planned activities or are plans to acquire and install new equipment appropriate?
• Does the research describe adequate sample tracking, workflow, and quality control to provide the required analytical services to study investigators?
• Do the investigators have experience with peak identification and characterization for discovery and measures of new analytes associated with exposure and disease?
• Are data processing and coordination with the Data Center adequate for transferring analytical data to the data repository?
• Do the investigators provide expertise in analysis and processing of global metabolite data needed for interactions with other Resources within the laboratory Hub, with the Data Center and with the study investigators?
• Does the Resource Director provide a plan to ensure efficient and effective day-to-day administrative operations of the Untargeted Analysis Resource?

Reviewers will evaluate the following resource and provide an overall score based on the individual review criteria for each required resource. Individual criterion scores will not be assigned.

Reviewers should consider the individual bulleted elements in their overall assessment in terms of scientific and technical merit, and in providing overall impact score:

• Do the investigators provide the necessary complementary expertise in appropriate technologies and other methods for measuring response indicators or markers in stored biological samples?
• Is the existing infrastructure sufficient to support the planned activities or are plans to acquire and install new equipment appropriate?
• Is there adequate expertise in place to ensure proper optimization of biomarker measures for children's health research including assessments of sensitivity, specificity, and reproducibility?
• Do the investigators provide the necessary expertise in data processing needed for interactions with Laboratory Hub and Data Center and with the study investigators?
• Does the Resource Director provide a plan to ensure efficient and effective day-to-day administrative operations of the Biological Response Indicators Resource?

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.

eRA Commons Help Desk (Questions regarding 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: http://grants.nih.gov/support/index.html
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
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 52 and 45 CFR Part 75.