Purpose

Human health is the product of both genetic susceptibility and environmental exposure.  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 an individual's health and wellbeing.  The National Institute of Environmental Health Sciences (NIEHS) intends to promote the characterization of the exposome (including chemical, physical, and biological stressors as well as lifestyle and social environments) through the establishment of an infrastructure to enable the measurement and integration of environmental exposures.  The proposed Human Health Exposure Analysis Resource (HHEAR) builds on the success of the Children's Health Exposure Analysis Resource (CHEAR, https://CHEARprogram.org/).  The HHEAR program will continue the essential structure of CHEAR with a consortium comprised of a Coordinating Center, Data Center, and a network of Laboratory Hubs.

Working in concert, the components of HHEAR will provide access to an infrastructure for adding comprehensive exposure analysis of biological samples and linked environmental samples to existing epidemiological and clinical studies involving research focused on understanding and improving human health.  HHEAR 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- and pooled analyses; and
• support for pilot and feasibility studies.

The harmonized laboratory analysis of samples based on rigorous quality control, as well as 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 instances this will provide the otherwise unattainable power to statistically analyze the combined contributions of multiple environmental factors on human health across a range of diseases and disorders. 

Exposures measured by HHEAR will encompass the breadth of the exposome using both comprehensive targeted (hypothesis-driven) and non-targeted (discovery-driven) methods of analysis.  HHEAR will expand the analyses provided by the current CHEAR infrastructure by the addition of a component focused on the analyses of environmental samples to provide greater resolution of the sources of environmental exposures. The comprehensive approach that HHEAR offers to the scientific research community will leverage new data on environmental exposures for discovery of new hypotheses and associations and promote research projects to address common challenges in research on environmental health.

The intent of the program is broad and will cover a range of epidemiological or clinical study designs.  Potential users of this resource include researchers studying the influence of non-genetic factors on human health, including studies with characterization of environmental exposures that could benefit from a more extensive, exposome-scale analysis, as well as studies that currently have little characterization of exposures that would benefit from adding exposure analysis to their existing data.

Background and Rationale

There is a rich and growing body of literature arising from the environmental health research community demonstrating that consequences of environmental exposures, particularly during critical periods in development, can manifest as disease or dysfunction at any point across the life span from infancy to old age. The original CHEAR program was explicitly focused on children as they are known to have increased risks from environmental exposures, including nutrition, stress, drugs, and environmental pollutants because their major organ systems are developing from the time of conception through adolescence.  HHEAR expands this focus to include exposures occurring in other life stages and health outcomes that occur later in life to enable a life-course perspective on differing responses to the environment. Environmental health effects are complex and not simple one-to-one relationships between exposure to a single chemical entity and a single health endpoint.  The comprehensive combination of data provided by HHEAR will facilitate an understanding of the complicated interactions between the multiple environmental and other factors as determinants of health.

The HHEAR infrastructure will facilitate the harmonization of data across studies by providing a focused infrastructure for comprehensive exposure analysis of biological and environmental samples including (1) rigorous assessment of a range of environmental exposures and (2) statistical tools and data science approaches to manage and analyze these newly generated datasets in a cohesive and integrated manner.

Specific Research Objectives

This Funding Opportunity Announcement (FOA) solicits a Coordinating Center for the Human Health Exposure Analysis Resource (HHEAR).  The HHEAR Coordinating Center (CC) will serve as the administrative hub and external access point for HHEAR, managing the flow of project materials and analyses between HHEAR units and participating clients.

The four main functions of the CC are to:

• Coordinate interactions of the research community with the HHEAR infrastructure including a process for receiving and evaluating client proposals,
• Implement and manage an internal workflow process for assigning and tracking all activities conducted by HHEAR units,
• Provide governance and administrative support to HHEAR, and
• Develop educational and outreach activities to facilitate exposure analysis in the broader human health research 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 HHEAR.  The foundation of this will be a user-friendly, intuitive, and easily navigable website to facilitate researchers' access to and use of the infrastructure (i.e. a database for methods and tools in HHEAR).

The CC will establish and oversee a process to provide HHEAR consulting services utilizing expertise from the HHEAR Lab Hubs and Data Center.  The consultation will assist in study design and the selection of optimal analyses to be conducted to support the client’s proposal and sample availability.  It will also manage an electronic process for proposal submission and coordinate proposal evaluation by HHEAR experts and consultants (potentially including subcontracted experts as needed).  As part of the proposal process, the CC will also advise study investigators of required documentation including Institutional Review Board approval, material transfer agreements, and data sharing and use policies of the HHEAR consortium.   

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 HHEAR; this effort will require active cooperation and agreement from both the laboratories and data center. The system will also track service capacity (laboratory and statistical), work assignments, and progress on services being performed within the network.  This workflow will support standardization of operational processes related to sample handling such as sample labeling, shipment, and storage, and coordination between laboratories and the statistical resource components. The CC will facilitate the Laboratory Network efforts to harmonize exposure analyses through organizing and facilitating focused group discussions.  The CC will support Laboratory Network efforts on quality assurance and quality control by evaluating laboratory adherence to HHEAR QA/QC policies, facilitating QA/QC workgroup meetings and integrating QA/QC and proficiency testing performance into work assignments. As part of this task, the CC will develop processes to evaluate the adherence to HHEAR policies and the quality of services provided including both data quality and efficiency of services.

Governance and administrative support to the HHEAR components

Integral to the success of the HHEAR program are communication and interaction between the units of HHEAR.  The coordinating center, in conjunction with NIH staff, will organize oversight committees including internal Steering and Executive Committees and external Scientific Expert Panel.  The CC will be responsible for coordinating the implementation of policies agreed to by the Steering and Executive Committees.  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 investigators/clients from selected projects utilizing the HHEAR infrastructure.

The CC will also be responsible for establishing and managing a Pilot and Feasibility Program which will support either expansion of the HHEAR 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.

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 HHEAR.  These can include a wide range of efforts to understand the importance of exposure assessment in the context of health research such as the Global Burden of Disease reports, the CDC National Exposure Report, the Comparative Toxicogenomics Database and the NIH ECHO and All of Us Research Programs  In addition this could include analytical guidance through protocols from the HHEAR laboratories, international efforts on metabolomics and untargeted analyses of exposure, or additional resources to inform exposure assessment and health outcomes.

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

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.

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

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

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

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, Jr., PhD
Telephone: 984-287-3340
Fax: 301-480-3722
Email: worth@niehs.nih.gov

All page limitations 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 an application to this FOA. All instructions in the SF424 (R&R) Application Guide must be followed. All instructions in the SF424 (R&R) Application Guide must be followed. All instructions in the SF424 (R&R) Application Guide must be followed. All instructions in the SF424 (R&R) Application Guide must be followed.

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

• Epidemiological sciences in particular environmental epidemiology;
• Ethical, Legal, and Social Issues (i.e. privacy protection and informed consent) related to epidemiological research;
• Exposure science;
• Project Management;
• Coordination of service-oriented infrastructure programs that are geographically distributed;
• Web development and use of social media for marketing and promotion of scientific programs;
• Team science for facilitating cooperation between diverse scientific communities including laboratory scientists, data scientists, statisticians, and epidemiologists;
• Technical expertise within the range of laboratory, statistical, and data science topics included in the HHEAR infrastructure.

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

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 HHEAR 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 coordinating interactions with external clients, including but not limited to:

• Developing and maintaining a web-based system for clients to access services offered by HHEAR;
• Maintaining a system for client proposal intake, tracking, review, and assignment,
• Interacting with clients, Lab Hubs, and the Data Center regarding required documentation for accepted projects including final analysis plans, IRB, materials transfer, and data sharing agreements.
• Creating a database and on-line dissemination strategy for methods and tools available to the broader research community;

Plans for managing the workflow and coordination among HHEAR Lab Hubs and Data Center, including but not limited to:

• Interacting with HHEAR consortium members to facilitate and assess project flow and address other project issues that may arise;
• Tracking service capacity, work assignments, and progress;
• Tracking laboratory proficiency testing results and adherence to quality control policies;
• Coordinating with the laboratories for supporting their harmonization of exposure analysis and sample handling; and
• Coordinating with Data Center and the laboratories to evaluate the efficiency of HHEAR internal processes and performance.

Plans for providing administrative support for the activities of HHEAR, including but not limited to:

• Prioritizing and incorporating improvements into HHEAR operations that enhance its utility for the external research community;
• Supporting the activities of the HHEAR Steering and Executive Committees and any subcommittees, as well as the Scientific Expert Panel (see below);
• Organizing and supporting the logistics of face-to-face meetings of the Steering and Executive Committees as well as additional in-person meeting for all HHEAR grantees and participating users of the infrastructure.
• Determining a schedule and organizing interim teleconferences with the Steering and Executive Committees and any required subcommittees as well as the Scientific Consulting Panel (described below) as appropriate.

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

• Developing and implementing a communication strategy to market HHEAR, including training and outreach to prospective users and the broader research community; and
• Compiling, accessing, and disseminating available exposure analysis capabilities beyond HHEAR

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 human health research that could be integrated into the projects supported by HHEAR.

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 HHEAR Steering Committee.

• • The HHEAR Program encourages sharing of resources with broad availability of policies, practices, materials, and tools to facilitate collaboration, reuse, and replication, both in other HHEAR supported projects and by other exposure assessment, children's health and environmental epidemiology researchers. In addition, the HHEAR 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 HHEAR 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 HHEAR steering committee post award.
  • In addition, the HHEAR 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

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide. When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

All instructions in the SF424 (R&R) Application Guide must be followed. Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy. Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed). Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field. 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. 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. The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in, and otherwise working jointly with, the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

 The PD/PI (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 HHEAR component in accordance with terms and conditions of the award.

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

 Defining objectives and approaches for HHEAR and its components;

• Overseeing the planning, budgeting, and conducting of all HHEAR scientific, organizational, and administrative activities specific to the PD(s)/PI(s)'s specific award as well as sharing information with other HHEAR awardees to facilitate such activities among the other HHEAR components;
• Promoting, coordinating, and participating in scientific collaborations and approaches across HHEAR components;
• Promoting, coordinating, or participating in collaborations between HHEAR and external investigators, including active participation in consultations, data sharing, and collaborative research projects with investigators using the HHEAR infrastructure;
• Overseeing or participating in the training of external investigators using HHEAR (including prospective users);
• Establishing agreements amongst themselves and NIH staff that address the following issues:

• Providing goals and estimated costs for analyses;
• Policy and procedures for transferring data among HHEAR components and external investigators;
• Establishing and adhering to data and metadata standards and sharing data, protocols, and other research resources generated by HHEAR components; 
• Procedures for safeguarding confidential information, including data generated by HHEAR components as well as information and/or data received from external investigators;
• Policy and procedures for addressing ownership of intellectual property that result from aggregate multi-party data; and
• Policy and procedures for reviewing publications and determining authorship

• Ensuring training of HHEAR personnel as needed for standardization of collaborative protocols across components and for accurate and timely data entry.  Participating in quality evaluations including round-robin and formal proficiency testing assessments.
• Overseeing improvements in HHEAR infrastructure; including the incorporation of methods developed within the Laboratory Network Hubs into other HHEAR activities.
• Ensuring adherence to the approved plans for timely sharing of resources and data amongst HHEAR components as well as with external investigators using the HHEAR infrastructure;
• Overseeing or participating in dissemination and outreach activities to promote use of HHEAR 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 HHEAR Steering and Executive Committees and interacting with any sub-committee(s);
• Complying with Coordinating Center requests, as directed by NIH Program Staff and the Executive Committee, to facilitate monitoring of HHEAR progress.
• Attending and participating in the annual PD/PI scientific meetings, and regular committee calls organized by the HHEAR Coordinating Center, as relevant
• Accepting and implementing all scientific, organizational, administrative, and policy recommendations approved by the HHEAR Executive Committee to the extent consistent with applicable grant regulations;
• Cooperating in the program evaluation process and interacting with NIH representatives and the Scientific Expert Panel 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 HHEAR Coordinating Center will have the following additional responsibilities:

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

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 HHEAR 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 HHEAR 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 HHEAR 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 HHEAR by:

 Monitoring the operations of HHEAR components and activities;

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

NIH staff members who are substantially involved in the scientific activities (e.g., publications) of the HHEAR 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 HHEAR 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 HHEAR 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:

HHEAR Steering Committee.

 The HHEAR Steering Committee will serve as the main body for deliberation for the HHEAR Program including discussion of current and prioritization of future activities.  As a deliberative body the Steering Committee is intended to provide consensus recommendations to the HHEAR Executive Committee.

The Steering Committee will consist of the following voting members:

• HHEAR PD(s)/PI(s);
• Up to two additional designees from each HHEAR component; and
• The NIH Program Officer(s) and Project Scientists for each HHEAR Component.

The HHEAR Steering Committee may also form subcommittees, each with a specific functional area of oversight as defined in the application.  Members of Steering Committee subcommittees need not be voting members of the Steering Committee.

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.

The Steering Committee will meet via web conference on a regular schedule determined collectively by the group with approval from the Executive Committee.  The Steering Committee will meet in-person at least once per year at a date and location determined by the Executive Committee.

HHEAR Executive Committee.

 The HHEAR Executive Committee will serve as the main decision-making body for the HHEAR Program.  The HHEAR Executive Committee will meet via web conference on a regular schedule agreed by the members and at in-person meetings of the HHEAR Steering Committee.  Additional in-person meetings of the Executive Committee may be held at the request of NIH Program Directors or other members by majority vote.

The HHEAR Executive Committee will have primary responsibility for:

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

The Executive Committee will consist of the following voting members:

• HHEAR PD(s)/PI(s);
• The NIH Program Directors/Officer.

Each component of the HHEAR infrastructure will have one collective vote, including NIH Program staff.  For multi-PI/PD grantees or Laboratories funded to conduct more than one analysis type, one designee will be selected to cast the collective vote of that unit.

Additional, non-voting, members of the HHEAR consortium may attend and participate in Executive Committee meetings with the assent of the group; such participants will not be voting members.

In the event that the Executive 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.

The PD/PI of the Coordinating Center will serve as Executive Committee Chair the first year of the program; thereafter, a Chair will be elected every twelve months 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 Executive Committee Chair.

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

Scientific Expert Panel.

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

 Serving as the review and prioritization body for HHEAR client studies;

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten on-time submission, and post-submission issues)

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application processes and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

David M. Balshaw, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3234
Email: Balshaw@nih.gov

Jennifer B. Collins, MR
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3247
Email: Collins6@niehs.nih.gov

Claudia L. Thompson, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3330
Email: Claudia.Thompson@nih.gov

Linda Bass, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3236
Email: Bass@niehs.nih.gov James Williams
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3338
Email: williamsjr@niehs.nih.gov 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.