Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Environmental Health Sciences (NIEHS)

Funding Opportunity Title

Children's Health Exposure Analysis Resource (CHEAR): Coordinating Center (U24)

Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

Announcement Type

New

Related Notices

  • March 11, 2015 - Technical Assistance Webinar for the Children's Health Exposure Analysis Resource (CHEAR) Funding Opportunity Announcements (RFA-ES-15-009, RFA-ES-15-010 and RFA-ES-15-011). See Notice NOT-ES-15-016.

Funding Opportunity Announcement (FOA) Number

RFA-ES-15-011

Companion Funding Opportunity

RFA-ES-15-009, U2C Resource-Related Research Multi-Component Projects and Centers Cooperative Agreements

RFA-ES-15-010, U2C Resource-Related Research Multi-Component Projects and Centers Cooperative Agreements

Number of Applications

Only one application per institution is allowed. See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.113

Funding Opportunity Purpose

NIEHS is establishing an infrastructure, the Children’s Health Exposure Analysis Resource (CHEAR), to provide the extramural research community access to laboratory and statistical analyses to add or expand the inclusion of environmental exposures in their research.  CHEAR is being solicited through three FOAs, this FOA solicits a Coordinating Center. In addition, FOAs are being released to solicit  a National Exposure Assessment Laboratory Network and an Exposure Data Repository and Resource for Statistical Analysis and Methods Development.  

The CHEAR Coordinating Center (U24) will serve as the administrative hub and external access point for CHEAR, managing the flow of materials, data, and analyses between CHEAR units and participating investigators.  In addition, the coordinating center will also support administrative functions such as convening steering committee and CHEAR meetings, and organize communication and outreach activities.

Key Dates
Posted Date

February 26, 2015

Open Date (Earliest Submission Date)

March 30, 2015

Letter of Intent Due Date(s)

March 30, 2015

Application Due Date(s)

April 30, 2015, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

June 2015

Advisory Council Review

August 2015

Earliest Start Date

September 2015

Expiration Date

May 1, 2015

Due Dates for E.O. 12372

Not Applicable

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). 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.

Table of Contents

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

Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Purpose

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.

Background and Rationale

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.

Specific Research Objectives

This Funding Opportunity Announcement (FOA) solicits a Coordinating Center for the Children’s Health Exposure Analysis Resource (CHEAR).  CHEAR is a multi-unit infrastructure to provide access to comprehensive exposure assessment for NIH funded studies of children’s health.  The CHEAR Coordinating Center (CC) will serve as the administrative hub and external access point for CHEAR, managing the flow of materials, data, and analyses between CHEAR units and participating investigators.   In addition, the coordinating center will support administrative functions such as convening steering committee and CHEAR meetings, and organize communication and outreach activities.  The four main functions of the CC are to:

  • Coordinate interactions of the research community with the CHEAR infrastructure including a process for receiving and evaluating proposals
  • Develop and implement an internal workflow process for assigning and tracking all activities conducted by CHEAR units
  • Provide governance and administrative support to the CHEAR units
  • Develop resources to facilitate exposure analysis in the broader community 

Coordinating consulting activities, and proposal submission and evaluation

A primary function of the coordinating center will be to serve as the point of contact for the research community and managing access to the services provided by the resource.  In order to accomplish this, the CC will maintain a compendium of expertise; analytical, statistical, and informatic methodologies; and roster of consulting experts across CHEAR.  This information will be used to assemble a user-friendly, intuitive, and easily navigable website to facilitate researchers' information-gathering, selection of consulting services, and use of the infrastructure (i.e. a database for methods and tools in CHEAR).

The CC will establish and oversee a process to provide consulting services, assisting in study design and the selection of optimal services and instruments prior to proposal submission.  It will also establish an electronic process for proposal submission and coordinate proposal evaluation by CHEAR experts and consultants (potentially including subcontracted experts as needed).  As part of the proposal process, the CC will also advise study investigators of Institutional Review Board concerns which may impact their ability to utilize the resource or affect data sharing.  The CC will also support negotiation of Material Transfer Agreements as required.  Where appropriate, the CC will also aid investigators in preparing data summaries which can be shared with study participants to inform them of the impact of the research to which they contributed.

Manage internal workflow

The second major task of the CC will be the establishment and maintenance of a portal and tracking system for managing workflow and coordination within CHEAR; this effort will require active cooperation and agreement from both the laboratories and data center.  This will support the roster of CHEAR expertise for analytical /data services and consulting.  The system will also track service capacity (laboratory and statistical), work assignments, and progress on services being performed within the network.  As part of this task, the CC will develop processes to evaluate the adherence to CHEAR policies and the quality of services provided including both data quality and efficiency; this will be used to support standardization of exposure analysis, sample handling, and coordination between laboratories and the statistical resource components. The CC will facilitate the Laboratory Network efforts to harmonize analyses between the Hubs through either Round Robin or Ring Trial assessments.

Governance and Administrative support to the CHEAR components

Integral to the success of the CHEAR program are communication and interaction between the units of the resource.  The coordinating center, in conjunction with NIH staff, will organize oversight committees including an internal steering committee and external Scientific Consulting Panel.  The CC will be responsible for coordinating the implementation of policies agreed to by the Steering Committee.  As needed, the CC will organize additional, topic specific, workgroups within the resource. The CC will organize regular teleconferences of the steering committee, an annual in-person Steering Committee meeting, and an annual grantee meeting including select projects utilizing the CHEAR infrastructure.

The CC will also be responsible for establishing and managing a Pilot and Feasibility Program which will support either expansion of the CHEAR infrastructure or small projects with the external research community to generate preliminary data in support of larger studies.

Resources to facilitate exposure analysis in the broader community 

The CC will establish and maintain a communications presence including web page and social media strategy, will actively market the capabilities of the resource, and provide user support, training, and outreach regarding the use of the resource to external researchers.

In order to expand the incorporation of exposure analysis in epidemiologic and clinical studies, the CC will establish a suite of available exposure resources beyond the capabilities of CHEAR.  These can include creation of a catalog complimentary to the PhenX toolkit (https://www.phenxtoolkit.org/) of existing and validated tools such as survey instruments or personal exposure monitors, as well as unique biomonitoring capabilities. 

The CC will also provide a forum to facilitate collaboration in the research community.  This can include capabilities such as establishing a discovery index which will allow researchers to find archived biological samples and sample repositories which have broad approval for availability to research purposes beyond their original intent.  This discovery index will also afford opportunities for identifying potential collaborators.  The later function can build off of existing Expert Finder tools such as the NIH supported VIVO resource (http://vivoweb.org/) and will enable matchmaking scenarios such as tool developers looking for opportunities to field test new devices, epidemiological studies looking for emerging tools or looking to combine analyses.

Finally, the CC will also provide an interface with other projects being solicited through the NIH National Children's Study transition.  In particular, an interface with the National Institute of Biomedical Imaging and Bioengineering (NIBIB) led Pediatric Research using Integrated Sensor Monitoring Systems (PRISMS) Network will be established.

Section II. Award Information
Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

New

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NIEHS intends to commit $5.0M total costs in FY 2015 to fund 1 award.

Award Budget

Application budgets are limited to $3.3 million direct cost to cover the project period of 4 years.

Award Project Period

The award project period is limited to 4 years. 

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.

Section III. Eligibility Information
1. Eligible Applicants
Eligible Organizations

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
Foreign Institutions

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.

Required Registrations

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.
  • 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.

Eligible Individuals (Program Director/Principal Investigator)

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.

2. Cost Sharing

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

3. Additional Information on Eligibility
Number of Applications

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).

 Applicant organizations submitting an application to RFA-ES-15-009 may not submit an application to this FOA.

Section IV. Application and Submission Information
1. Requesting an Application Package

Applicants must download 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.

2. Content and Form of Application Submission

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. 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.

Letter of Intent

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

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

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

The letter of intent should be sent to:

Leroy Worth, PhD
Telephone: 919-541-0670
Fax: 301-480-3722
Email: Worth@niehs.nih.gov

Page Limitations

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

Instructions for Application Submission

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

The Senior/Key personnel should emphasize relevant experience in the following areas:

  • Epidemiological sciences in particular environmental epidemiology and ethical issues (i.e. privacy protection and informed consent) related to epidemiological research;
  • Exposure science;
  • Project Management including creativity and innovation in solving technical and project challenges, including service oriented infrastructure programs that are geographically distributed;
  • Web development and use of social media for marketing and promotion of scientific programs;
  • Facilitating cooperation between diverse scientific communities including laboratory scientists, data scientists, statisticians, and epidemiologists;
  • Familiarity with the range of laboratory, statistical, and data science topics included within the CHEAR infrastructure; and
  • Developing and overseeing a communications strategy including web and social media approaches.
R&R Budget

All instructions in the SF424 (R&R) Application Guide must be followed. In the application, research project budget requests must include costs for the PD/PI and up to two other members of the Coordinating Center to attend both the initial in-person CHEAR meeting in Durham, NC and the annual grantee meeting in a location to be determined.  Costs for the PD/PI and key staff, as well as the non-federal members of the Scientific Consulting Panel (assume 6), to attend an annual grantees meeting should also be included.

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Specific Aims: The main objective of the Coordinating Center (CC) is to serve as an external access point for the extramural research community and as the administrative unit for the CHEAR Program and as described above. Applicants should outline specific aims to address these goals.

Research Strategy: Applicants must describe how the central objectives of the Coordinating Center will be accomplished as outlined in the proposed specific aims for this resource including but not limited to:

Plans for providing coordinating interactions with external researchers, including but not limited to:

  • Developing a web-based system to access services offered by CHEAR components;
  • Creating a database for methods and tools available to users of CHEAR;
  • Creating a system for proposal intake, tracking, review and assignment, including a discussion of criteria which will be used for the basis of accepting projects into the Resource; and
  • Interacting with researchers on accepted projects on IRB, materials transfer, and data considerations.

Plans for managing the workflow and coordination among CHEAR research supporting units,, including but not limited to:

  • Interacting with CHEAR Laboratory Network and the Statistical Services to facilitate and assess project flow and address other data issues that may arise;
  • Tracking service capacity, work assignments, and progress;
  • Evaluating quality control of the services rendered;
  • Coordinating with the laboratory network for supporting standardization of exposure analysis and sample handling; and
  • Evaluating the data quality and efficiency of CHEAR including performance assessments.

Plans for providing administrative support for the activities of the CHEAR research supporting program, including but not limited to:

  • Providing a public website and other social media for communication and sharing of activities, events, and resources of the program;
  • Prioritizing and incorporating improvements into CHEAR operations and software that enhance its utility for research;
  • Supporting the activities of the CHEAR Steering Committee  and any subcommittees, as well as the Scientific Consulting Panel; see below);
  • Organizing and supporting the logistics of one face-to-face meeting of the Steering Committee of approximately 1.5 days in each year of the award as well as one additional in-person meeting for all CHEAR grantees and participating users of the infrastructure.
  • Determining a schedule and organizing interim teleconferences with the Steering Committee and the Scientific Consulting Panel (described below) ESP as appropriate.

Plans for providing resources to facilitate exposure analysis in the broader children's health research community, including but not limited to: 

  • Developing and implementing a communication strategy to market CHEAR, including training and outreach to prospective users;
  • Compiling and accessing available exposure analysis capabilities beyond CHEAR; and
  • Establishing a forum for facilitating collaboration in the research community.

The applicant should discuss their approach for engaging with other organizations and projects working in similar areas, and staying abreast of emerging exposure and statistical methods and children’s health research that could be integrated into the other projects supported by CHEAR.

The exact boundaries of the activities of CHEAR, including the Laboratory Network, Data Center, and Coordinating Center are not possible to predict at this time, and will depend in large part on the capacities and experience of the teams awarded and methods developed within the program. Some of these responsibilities will, therefore, need to be negotiated once the program is funded and started. Applicants should describe their willingness to be flexible in determining areas of responsibility in this collaborative program. The CC will not be responsible for data coordination within the Resource. The CC will, however, be responsible for managing the flow of work assignments, and samples, among the various CHEAR units.

Timeline for Achieving Objectives

As noted above, applicants are encouraged to be creative and flexible in the approach to achieving the four objectives for the CC outlined above, but should include a timeline that describes when and how the PD(s)/PI(s) will complete the activities proposed to achieve the CC objectives.  Applicants should also keep in mind that actual activities and completion dates may change following consultation with NIH staff and the CHEAR Steering Committee.

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 and with applicable federal laws, regulations, and rules.  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 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.

Planned Enrollment Report

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

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

3. Submission Dates and Times

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). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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.

6. Other Submission Requirements and Information

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

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by NIEHS, 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 McNair1@niehs.nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

Section V. Application Review Information
1. Criteria

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.

Overall Impact

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

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of 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 impact.

Significance

Is the proposed Coordinating Center needed to achieve the goals of the external children's health research community it proposes to serve and does it provide the necessary resources to support the CHEAR infrastructure?  Will coordinated administration of the resource facilitate or expedite extramural research that would be delayed or infeasible if conducted as independent projects?  What advantages will the Center bring to the research community to the concept of advancing exposure analysis in children's health research?

Investigator(s)

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

Innovation

Does the application propose novel organizational concepts, management strategies, or instrumentation in coordinating the research community the Center will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts, management strategies or instrumentation proposed?  Does the proposed plan allow for technological advances (i.e. upgrades to relevant software or development of new software) during the project period? What innovative outreach and/or user interface approaches will be used to ensure extensive use of the CHEAR by the scientific community? 

Approach

Are the overall design, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the CHEAR Resource and the research community the Coordinating Center will serve?    Are potential problems, alternative strategies, and benchmarks for success presented? If the Center is in the early stages of operation, will the strategy establish feasibility and will particularly risky aspects be managed? Does the proposed plan outline a strategy to successfully bridge the CHEAR infrastructure to the external research community?  Will the proposed plans for portal development and process management support the coordination of the CHEAR infrastructure?  Will the outreach activities proposed advance the field of exposure analysis in the broader research community? 

Environment

Will the institutional environment in which the Center will operate contribute to the probability of success in facilitating the research community it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Center proposed? Will the Center benefit from unique features of the institutional environment, infrastructure, or personnel?  Is the existing hardware and software capacity (servers, web-based portals) adequate for the needs of the CHEAR program? Does the proposed plan include adequate privacy and security protections? Are there sufficient commitments of facilities, infrastructure, and other resources to allow for the full scale operation over time?

Additional Review Criteria

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children 

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable

Renewals

Nor Applicable

Revisions

Not Applicable

Additional Review Considerations

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

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

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

Resource Sharing Plans

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

Budget and Period of Support

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

2. Review and Selection Process

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.
3. Anticipated Announcement and Award Dates

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.

Section VI. Award Administration Information
1. Award Notices

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.

2. Administrative and National Policy Requirements

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 P Ds/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.
  • The contact PD/PI of the CC will serve as chair of the Steering Committee for the first award year. Thereafter, other Steering Committee members may serve as chair on a rotating basis, as agreed by the Steering Committee.

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

3. Reporting

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.

Section VII. Agency Contacts

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

Application Submission Contacts

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: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-435-0714

Scientific/Research Contact(s)

David M. Balshaw, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-2448
Email: Balshaw@nih.gov

Claudia Thompson, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-4638
Email: Claudia.Thompson@nih.gov

Peer Review Contact(s)

Linda Bass, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-1307
Email: Bass@niehs.nih.gov

Alfonso Latoni, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-7571
Email: Alfonso.Latoni@nih.gov  

Leroy Worth, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-0670
Email: Worth@niehs.nih.gov

Financial/Grants Management Contact(s)

George Tucker
National Institute of Environmental Health Sciences (NIEHS))
Telephone: 919-541-2749
Email: TuckerG@mail.nih.gov

Section VIII. Other Information

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.

Authority and Regulations

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

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