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
Human Health Exposure Analysis Resource: Coordinating Center (U24 Clinical Trial Not Allowed)
Activity Code
U24 Resource-Related Research Projects – Cooperative Agreements
Announcement Type
Reissue of RFA-ES-15-011
Related Notices
None
Funding Opportunity Announcement (FOA) Number
RFA-ES-18-010
Companion Funding Opportunity
RFA-ES-18-011, U2C Resource-Related Research Multi-Component Projects and Centers Cooperative Agreements

RFA-ES-18-012, U2C Resource-Related Research Multi-Component Projects and Centers Cooperative Agreements

RFA-ES-18-013, U2C Resource-Related Research Multi-Component Projects and Centers Cooperative Agreements

RFA-ES-18-014, U2C Resource-Related Research Multi-Component Projects and Centers Cooperative Agreements

Catalog of Federal Domestic Assistance (CFDA) Number(s)
93.113
Funding Opportunity Purpose

The NIEHS is establishing an infrastructure, the Human Health Exposure Analysis Resource (HHEAR) as a continuation of the Children's Health Exposure Analysis Resource (CHEAR).  The goal of this consortium is to provide the research community access to laboratory and statistical analyses to add or expand the inclusion of environmental exposures in their research and to make that data publicly available as a means to improve our knowledge of the comprehensive effects of environmental exposures on human health throughout the life course.

HHEAR is comprised of three primary components solicited through five FOAs:

This FOA solicits the HHEAR Coordinating Center (U24) that will serve as the administrative hub and external access point for HHEAR, managing and tracking the flow of projects, materials, and analyses between HHEAR units and participating investigators. In addition, the coordinating center will support administrative functions such as convening HHEAR Steering and Executive Committee meetings, and organizing education, outreach, and publicity activities.

Key Dates

Posted Date
August 30, 2018
Open Date (Earliest Submission Date)
September 29, 2018
Letter of Intent Due Date(s)
September 29, 2018
Application Due Date(s)
October 29, 2018. No late applications will be accepted for this Funding Opportunity Announcement.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)
Not Applicable

.

Scientific Merit Review
March 2019
Advisory Council Review
June 2019
Earliest Start Date
August 2019
Expiration Date
October 30, 2018
Due Dates for E.O. 12372
Not Applicable
Required Application Instructions
It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide,except where instructed to do otherwise (in this FOA or in a Notice from 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.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.
  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

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.
See Section VIII. Other Information for award authorities and regulations.

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. See Section VI.2 for additional information about the substantial involvement for this FOA.

Application Types Allowed
New
Renewal

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

Clinical Trial?
Not Allowed: Only accepting applications that do not propose clinical trials

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

NIEHS intends to commit $1.0 M in FY 2019 to fund 1 award.

Award Budget
Application budgets are limited to $700,000 Direct Costs per year and need to reflect the actual needs of the proposed project.
Award Project Period
The project period is limited to 5 years.   
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from 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 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.

3. Additional Information on Eligibility

 

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)

Section IV. Application and Submission Information

1. Requesting an Application Package

Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide 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.

 

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

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;
  • 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.

Budget requests must include costs for the PD/PI and at least two other members of the Coordinating Center, as well as the non-federal members of the Science Expert Panel (assume 6), to attend two consortium meetings in each grant year.  In addition, the Coordinating Center should include reasonable projections of costs for meeting space and associated technical support for these meetings.
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 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.
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.

The following modifications also apply:

    • 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
Appendix:
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
PHS Human Subjects and Clinical Trials Information
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:

Delayed Onset Study

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

PHS Assignment Request Form
All instructions in the SF424 (R&R) Application Guide must be followed.

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and times. 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. When a submission date falls on a weekend or Federal holiday , the application deadline is automatically extended to the next business day.

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 and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

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.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. 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.

7. 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. For assistance with application submission, contact the Application Submission Contacts in Section VII.

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 atmcnair1@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 the policy. Any instructions provided here are in addition to the instructions in the policy.

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 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).
Scored Review Criteria
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.

 

Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Is the proposed Coordinating Center needed to achieve the goals of the external environmental health research community it proposes to serve and does it provide the necessary resources to support the HHEAR 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 Coordinating Center bring to the research community to the concept of advancing exposure analysis in health research?

 

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Do the PD(s)/PI(s) and other personnel have appropriate experience and training, and have they demonstrated an ongoing record of excellence in managing community-wide research projects?   

 

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Does the application propose novel organizational concepts, management strategies, or instrumentation in coordinating the research community the Center will serve?  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 HHEAR by the scientific community? 

 

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

Are the overall design, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of HHEAR and the research community the Coordinating Center will serve?  Does the proposed plan outline a strategy to successfully bridge the HHEAR infrastructure to the external research community?  Will the proposed plans for portal development and process management support the coordination of the HHEAR infrastructure?  Will the outreach activities proposed advance the field of exposure analysis in the broader research community? 

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

 

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Is the existing hardware and software capacity (servers, web-based portals) adequate for the needs of the HHEAR 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.

 

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

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

 

When the proposed 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.

 

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

 

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

 

Not Applicable

 

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

 

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.

 

Not Applicable

 

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

 

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

 

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

 

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), 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 on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. 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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency.  HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements.  FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award.  An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS.  The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.”  This provision will apply to all NIH grants and cooperative agreements except fellowships.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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 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

3. Reporting

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.
A final RPPR, 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.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.

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 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

Scientific/Research Contact(s)

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

Peer Review Contact(s)
Linda Bass, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3236
Email: Bass@niehs.nih.gov
Financial/Grants Management Contact(s)
James Williams
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3338
Email: williamsjr@niehs.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 52 and 45 CFR Part 75.


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