Department of Health and Human Services
Part 1. Overview Information

 

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Environmental Health Sciences (NIEHS)

Funding Opportunity Title

Human Health Exposure Analysis Resource (HHEAR): Data Repository, Analysis and Science Center (U2C Clinical Trial Not Allowed)

Activity Code

 U2C Resource-Related Research Multi-Component Projects and Centers Cooperative Agreements

Announcement Type

Reissue of RFA-ES-15-010

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-ES-18-014

Companion Funding Opportunity

RFA-ES-18-010, U24 Resource-Related Research Projects – Cooperative Agreements

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

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:

A Coordinating Center (RFA-ES-18-010)

A Data Center (RFA-ES-18-014)

A Network of Exposure Analysis Laboratories focused on:

Targeted analysis of biological samples (RFA-ES-18-011)

Untargeted analysis of biological samples (RFA-ES-18-012)

Environmental sample analysis (RFA-ES-18-013)

This FOA solicits the Data Center. The Data Center will provide intellectual and logistical support for the maintenance, integration, analysis, interpretation, curation, and reuse of data generated by HHEAR in support of extramural research projects. The Data Center will build and manage an exposure data repository and associated data science resources, including a public access Data Portal, a Data Submission and Review Portal, and an ontology and associated standardized data structure. In addition, the Data Center will provide statistical, analytical, and informatic support for HHEAR components and studies using the HHEAR infrastructure. The ultimate goal is maximizing potential use and impact of exposure data in human health studies. 

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

May 2019

Earliest Start Date

August 2019

Expiration Date

October 30, 2018

Due Dates for E.O. 12372

Not Applicable

** ELECTRONIC APPLICATION SUBMISSION REQUIRED**

NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically using ASSIST or an institutional system-to-system solution; paper applications will not be accepted.

Required Application Instructions

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.


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. Table of Contents

    Part 1. Overview Information
    Part 2. Full Text of the Announcement

    Section I. Funding Opportunity Description
    Section II. Award Information
    Section III. Eligibility Information
    Section IV. Application and Submission Information
    Section V. Application Review Information
    Section VI. Award Administration Information
    Section VII. Agency Contacts
    Section VIII. Other Information


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

    Purpose

    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 FOA solicits applications for the HHEAR Data Center. The main role for the HHEAR Data Center will be to provide intellectual and logistical support for the storage, maintenance, analysis, interpretation, curation, and integration of data generated by the network. The HHEAR Data Center will advance the overarching goal of HHEAR to provide access to tools to incorporate and extend exposure analysis on an exposome scale by providing the following data and analytic infrastructure: a Data Science Resource; a Data Repository and Management Core; a Statistical Services and Analysis Resource, and Administrative Core described in detail below.

    Data Science Resource:  Given the enormous amount and diversity of data anticipated, development/extension and implementation of robust data and metadata standards (e.g., ontologies, file exchange standards) are crucial to facilitating data integration across different human health studies supported by the network and more broadly in the larger environmental health sciences community. To the immediate needs of HHEAR, the Data Center will work with the Laboratory Network and the Coordinating Center to identify and implement existing data and metadata standards to support the establishment of the infrastructure. In concert with the Data Repository and Management Core and the Statistical Services and Analysis Resource, the Data Science Resource will contribute to building and maintaining a publicly available data portal through the development and implementation of tools and semantic infrastructure to make HHEAR data Findable, Accessible, Interoperable, Reusable (FAIR; https://www.nature.com/articles/sdata201618.pdf). The Data Science Resource will also lead a longer term, stakeholder-driven process to extend these and identify and address key gaps in existing standards in exposure domains represented in HHEAR. Data and metadata standards being developed and/or used in HHEAR will be catalogued and made available to the broader scientific community.

    Data science-related activities can include, but are not limited to:

    Development of semantic capability and the HHEAR ontology, integration of these technologies into the HHEAR Data Portal, and dissemination as a public resource. The HHEAR data center should build on existing infrastructure and data science resources developed by CHEAR (i.e. ontologies, resources, infrastructure, etc.), as appropriate;

    Working with the HHEAR Laboratory Network to identify and catalogue the most appropriate sets of data and metadata standards to collectively provide coverage of the full range of data types being generated through HHEAR;

    Develop processes and associated tools to facilitate the use and extension of data and metadata standards for data being generated by the Laboratory Network and/or deposited by researchers in the data repository;

    Maintaining accurate versioning of data and metadata standards being applied to HHEAR data sets and clear attribution of those data standards to the developers;

    Leading an effort to address gaps in existing data and metadata standards for exposures. This includes but is not limited to:

    o   Convening a data standards development workgroup that brings together HHEAR investigators with individuals possessing technical expertise (e.g., ontologists) needed to drive standards development in exposure science;

    o   Surveying the landscape of existing data standards in the environmental domain, including those currently in development, to identify gaps and opportunities to build on those ongoing efforts;

    o   Developing and supporting a process to identify and prioritize use cases that are of immediate relevance to HHEAR and that provide an opportunity to fill a data standards gap for environmental data; and 

    o   Managing an iterative process of developing, testing, tracking dependencies, and implementing data and metadata standards arising from the use cases (and the relevant data).

    Provide tools and infrastructure to support efforts around data aggregation and integration, including support for interoperability with other data sources, such as the Environmental Influences on Child Health Outcomes (ECHO) program and the NIH Metabolomics Workbench.

    Data Repository and Management Core:  The goal of the Data Repository and Management Core is to store and manage data and facilitate activities of HHEAR clients and the broader scientific community. Thus, the Core should be designed in a way to maximize data sharing and reuse of the large volume and heterogeneous types of data being collected while also facilitating its sustainable functioning in the future. It is expected that the Core will work with the Resource components of the Center to ensure appropriate data and metadata standards are employed. The HHEAR Data Center will establish and maintain a data repository and data management infrastructure to support collection, curation, display, storage, retrieval, integration, interoperability, and reuse of data produced by the HHEAR Laboratory Network.

    Key tasks can include but are not limited to:

    • Establish and manage a data repository with the capability to store and semantically aggregate all primary and processed data and associated metadata generated by the Laboratory Network as well as accompanying investigator-submitted study (meta)data (e.g., epidemiological data, questionnaire answers, demographics, geocoded location, etc.) including but is not limited to;

    o   Establish and maintain a user-friendly, intuitive, and easily navigable public and controlled-access data portal to facilitate researchers' data access;

    o   Develop and manage a process for HHEAR data access, including tracking requests, providing support for data requestors, verifying eligibility, managing a data access committee, documenting approval/denial and producing summary reports.  This includes working with the CC to collect and maintain accurate information about the extent and type of data sharing allowable in each study under informed consent agreements and other existing study/consortium policies;

    o   Collect and report metrics for data submission, quality assurance, access, and standards compliance to the NIH project staff; and

    o   Provide tutorials targeted at different user groups (e.g., naïve users, experienced bioinformaticians) to support data use and reuse;

    • Manage aspects of data flow between the Exposure Analysis Laboratories, Data Center, and clients.  

    o   Inform and assist the HHEAR Network Labs regarding recommended data workflows; and 

    o   Establish internal data sharing policies and procedures in collaboration with other HHEAR components;     

    • Support deposition, extraction, merging, mapping and/or federation of data from HHEAR and other relevant sources to the repository including coordination with other data repositories for exposure analysis such as the Environmental Influences on Child Health Outcomes (ECHO) program and the National Metabolomics Data Repository.

    Statistical Services and Analysis Resource:  The HHEAR Data Center will be responsible for providing statistical consultation, and as appropriate, directly perform statistical analyses for investigators utilizing the HHEAR Laboratory Network. In this role, it is anticipated that the Data Center will develop a faculty of individuals with expertise across a wide range of biostatistical and bioinformatics areas as well as exposure science and epidemiology to provide such services. The Statistical Services and Analysis Resource will catalyze the application and implementation of novel statistical, analytical, and bioinformatics methodologies and innovative approaches and study designs. In concert with the Data Repository and Management Core and the Data Science Resource, the Statistical Sevices and Analysis Resource will contribute to building a publicly available data portal through the adaption and/or development of an integrated suite of analysis tools, software packages, and educational materials. This resource will also support collaborative research projects, providing statistical consultations, tools, and approaches for the analysis of multi-faceted datasets in a cohesive and integrated manner.  

    The statistical services provided can include, but are not limited to:

    • Statistical, epidemiological, exposure science, and bioinformatics support for client study consultation and proposal review including aspects of study design and protocol development, sample size calculations, statistical analysis plans, and simulations;
    • Quality Control assessments for data provided by either HHEAR Clients or the HHEAR Laboratory Network;
    • Create final datasets and perform statistical analysis, and assist clients with the interpretation of results; such analyses in support of Client studies could include:

    o   Exploration of environmental exposure patterns and correlations;

    o   Mixed models of exposure and more sophisticated methods to deal with multiple exposures simultaneously;

    o   Integration of multiple types of high-dimensional data and incorporation of a variety of omics information (e.g., genomics, proteomics, metabolomics, etc.) with exposure data;

    o   Innovative approaches for intensive longitudinal data analyses; and

    o   Spatio-temporal modeling of environmental exposures and response;

    • Integrate publicly available statistical software that can be used by the research community for the statistical analysis of data in the HHEAR Data Repository; and
    • Partner with complementary Programs, such as

    o   The Powering Research Through Innovative Methods for Mixtures in Epidemiology (PRIME) Program (https://www.niehs.nih.gov/research/supported/exposure/mixtures/prime_program/index.cfm) on implementation of quantitative methods to understand complex relationships between environmental exposures and health outcomes; and

    o   The NIH Metabolomics Workbench (http://www.metabolomicsworkbench.org) on implementation of quantitative methods to analyze metabolomics data.

    Administrative Core:  Each Hub will have an Administrative Core that will coordinate all activities of the Lab Hub including:

    • Consulting with clients on statistical methods and design considerations and informatics resources available to assist in data interpretation;
    • Providing support for IRB review and attestation documentation, as well as management of data sharing and data use agreement documentation
    • Integration with Coordinating Center, other Hubs, and Data Center; and
    • Tracking sample handling and support quality assurance and proficiency testing and data flow coordination.

    See Section VIII. Other Informationfor 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 fund 1 award, corresponding to a total cost of $2.5 million, for fiscal year 2019. Future year amounts will depend on annual appropriations.

    Award Budget

    Application budgets are limited to $1.7 million direct costs per year.

    Award Project Period

     The award 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:

    • o   Hispanic-serving Institutions
    • o   Historically Black Colleges and Universities (HBCUs)
    • o   Tribally Controlled Colleges and Universities (TCCUs)
    • o   Alaska Native and Native Hawaiian Serving Institutions
    • o   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.
    • o   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 e RA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

    Eligible Individuals (Program Director/Principal Investigator)

    Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

    For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

    2. Cost Sharing

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

    3. Additional Information on Eligibility
    Number of Applications

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

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

    A button to access the online ASSIST system is available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

    Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

    2. Content and Form of Application Submission

    It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

    For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

    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

    Page Limitations

    Available Component Types

    Research Strategy/Program Plan Page Limits

    Overall

    12

    Admin Core (Use for the Administrative Core)

    6

    Core (Use for the Data Repository and Management Core)

    12

    Research Resource (Use for the Data Science Resource and the Statistical Services and Analysis Resource)

    12

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

    Instructions for the Submission of Multi-Component Applications

    The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

    The application should consist of the following components:

    • Overall: required
    • Administrative Core: required; maximum 1
    • Data Repository and Management Core: required; maximum 1
    • Research Resource: required; minumum 2; maximum  of 2
    • Data Science Resource; maximum of 1
    • Statistical Services and Analysis Resource; maximum of 1
    Overall Component

    When preparing your application in ASSIST, use Component Type ‘Overall’.

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

    SF424 (R&R) Cover (Overall)

    Complete entire form.

    PHS 398 Cover Page Supplement  (Overall)

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

    Research & Related Other Project Information (Overall)

    Follow standard instructions.

    Project/Performance Site Location(s) (Overall)

    Enter primary site only.

    A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

    Research & Related Senior/Key Person Profile (Overall)

    Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

    A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

    Budget (Overall)

    The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.  

    A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

    PHS 398 Research Plan (Overall)

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

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

    As part of this section, describe the following elements:

    Background:

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

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

    • Overview of all components (i.e. Resources and Cores) and their integration;
    • Plans for strategic oversight and coordination of effort among components;
    • Plans for fostering stakeholder engagement in the development and utilization of the resources and data available, and
    • Plans for collaboration and coordination with the broader HHEAR Network and other related programs (e.g. ECHO, NIH Common Fund Metabolomics Program). 

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

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

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

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

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

    The application must also describe plans for:

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

    Appendix:

    Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.   

    PHS Human Subjects and Clinical Trials Information (Overall)

    When involving NIH-defined human subjects research, clinical research, and/or clinical trials 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, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

    Study Record: PHS Human Subjects and Clinical Trials Information

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

    Delayed Onset Study

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

    PHS Assignment Request Form (Overall)

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

    Administrative Core

    When preparing your application, use Component Type ‘Admin Core.’

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

    SF424 (R&R) Cover (Administrative Core)

    Complete only the following fields:

    • Applicant Information
    • Type of Applicant (optional)
    • Descriptive Title of Applicant’s Project
    • Proposed Project Start/Ending Dates
    PHS 398 Cover Page Supplement (Administrative Core)

    Enter Human Embryonic Stem Cells in each relevant component.

    Research & Related Other Project Information (Administrative Core)

    Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

    Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

    Project Narrative:  Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

    Project /Performance Site Location(s) (Administrative Core)

    List all performance sites that apply to the specific component.

    Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

    Research & Related Senior/Key Person Profile (Administrative Core)
    • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Core Lead’ and provide a valid eRA Commons ID in the Credential field.
    • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
    • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
    • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used. 
    • The U2C PD/PI must serve as the Administrative Core Leader. 
    Budget (Administrative Core)

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

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

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

    Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

    PHS 398 Research Plan (Administrative Core)

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

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

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

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

    • Administrative, operations, and meeting support staff;
    • Business and/or legal expert staff;
    • Other staff required to support the Data Center as a whole; and
    • Plans and logistical support for meetings of Resource and Core leads as well as other relevant subcommittees;
    • Expertise in human subjects protections, IRB approvals, and public access sharing of human data.

    Support for internal evaluation and self-assessment, including:

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

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

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

    • Resource Sharing Plans are required, but they are discussed in the Overall component of this FOA.

    Appendix:

    Limited items are allowed in the Appendix.Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.   

    PHS Human Subjects and Clinical Trials Information (Administrative Core)

    When involving NIH-defined human subjects research, clinical research, and/or clinical trials 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 a 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.

    Delayed Onset Study

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

    Data Repository and Management Core

    When preparing your application, use Component Type ‘Core.’

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

    SF424 (R&R) Cover (Data Repository and Management Core)

    Complete only the following fields:

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

    PHS 398 Cover Page Supplement (Data Repository and Management Core)

    Enter Human Embryonic Stem Cells in each relevant component.

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

    Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

    Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

    Project Narrative:  Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

    Project /Performance Site Location(s) (Data Repository and Management Core)

    List all performance sites that apply to the specific component.

    Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

    Research & Related Senior/Key Person Profile (Data Repository and Management Core)

    • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Core Lead’ with Category of ‘Core Lead’ and provide a valid eRA Commons ID in the Credential field.
    • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
    • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
    • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used. 

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

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

    Budget (Data Repository and Management Core)

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

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

    Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

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

    PHS 398 Research Plan (Data Repository and Management Core)

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

    Research Strategy: Applications should describe the following:

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

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

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

    Operations management, including:

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

    Customer support capacity that may include the following:

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

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

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

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

    • Resource Sharing Plans are required, but they are discussed in the Overall component of this FOA.

    Appendix: Limited items are allowed in the Appendix.Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions. 

    PHS Human Subjects and Clinical Trials Information (Data Repository and Management Core)

    When involving NIH-defined human subjects research, clinical research, and/or clinical trials 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, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a 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.

    Delayed Onset Study

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

    Data Science Resource

    When preparing your application, use Component Type ‘Research Resource.’

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

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

    Complete only the following fields:

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

    PHS 398 Cover Page Supplement (Data Science Resource)

    Enter Human Embryonic Stem Cells in each relevant component.

    Research & Related Other Project Information (Data Science Resource)

    Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

    Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

    Project Narrative:  Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

    Project /Performance Site Location(s) (Data Science Resource)

    List all performance sites that apply to the specific component.

    Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

    Research & Related Senior/Key Person Profile (Data Science Resource)

    • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Resource Director’ with Category of ‘Project Lead’ and provide a valid eRA Commons ID in the Credential field.
    • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
    • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
    • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used. 

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

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

    Budget (Data Science Resource)

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

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

    Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

    Applicants should include resources in the budget to ensure an orderly transition of the semantic infrastructure/ontology at the end of the program period.

    PHS 398 Research Plan (Data Science Resource)

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

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

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

    To accomplish these key functions address the following:

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

    Note: primary data collection to support collaborative research or methods development projects is considered nonresponsive for this FOA.

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

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

    Operations management, including:

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

    Customer support capacity that may include the following:

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

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

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

    • Resource Sharing Plans are required, but they are discussed in the Overall component of this FOA.

    Appendix: Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.   

    PHS Human Subjects and Clinical Trials Information (Data Science Resource)

    When involving NIH-defined human subjects research, clinical research, and/or clinical trials 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, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a 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.

    Delayed Onset Study

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

     
    Statistical Services and Analysis Resource

    When preparing your application, use Component Type ‘Research Resource.’

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

    SF424 (R&R) Cover (Statistical Services and Analysis Resource)

    Complete only the following fields:

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

    PHS 398 Cover Page Supplement (Statistical Services and Analysis Resource)

    Enter Human Embryonic Stem Cells in each relevant component.

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

    Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

    Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

    Project Narrative:  Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

    Project /Performance Site Location(s) (Statistical Services and Analysis Resource)

    List all performance sites that apply to the specific component.

    Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

    Research & Related Senior/Key Person Profile (Statistical Services and Analysis Resource)

    • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Resource Director’ with Category of ‘Project Lead’ and provide a valid eRA Commons ID in the Credential field.
    • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
    • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
    • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used. 

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

    • Statistics and computational biology including, bioinformatics, statistical programming and statistical methods development; and
    • Environmental health science, epidemiology, and exposure science.

    Budget (Statistical Services and Analysis Resource)

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

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

    Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

    PHS 398 Research Plan (Statistical Services and Analysis Resource)

    Specific Aims: This Resource seeks to provide statistical consultation and analysis support to investigators utilizing the Laboratory Network resources, catalyze the application and implementation of novel statistical, analytical, and bioinformatics methodologies, as well as support collaborative research efforts. Applicants should outline specific aims to address these goals.

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

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

    Note: primary data collection  to support collaborative research or methods development projects is considered nonresponsive to this FOA.

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

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

    Operations management, including:

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

    Customer support capacity that may include the following:

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

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

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

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

    • Resource Sharing Plans are required, but they are discussed in the Overall component of this FOA.

    Appendix: Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.    

     PHS Human Subjects and Clinical Trials Information (Statistical Services and Analysis Resource)

    When involving NIH-defined human subjects research, clinical research, and/or clinical trials 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, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a 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.

    Delayed Onset Study

    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) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. 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.

    For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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

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

    Important reminders:

    All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

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

    See more tips for avoiding common errors.

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

    In order to expedite review, applicants are requested to notify the NIEHS Referral Office by email at mcnair1@niehs.nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

    Post Submission Materials

    Applicants are required to follow the instructions for post-submission materials, as described in 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 - Overall

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

    Scored Review Criteria - Overall

    Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a Center that by its nature is not innovative may be essential to advance a field.

    Significance

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

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

    Investigator(s)

    Are the PD(s)/PI(s), collaborators, and other researchers well suited to the proposed roles in the Data Center? 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? If the Center is collaborative or multi-PD/PI, do the investigators have complementary and integrated skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the Center described and sufficient to contribute to the likelihood of success of the Center? 

    Innovation

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

    Approach

    Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Center? 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?

    If the Center 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?   

    Are the overall design, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research community the Data Center will serve? Are the plans for sharing of exposure data adequate to the needs of the investigators utilizing HHEAR and to the larger research community while maintaining appropriate protection for privacy? Is a robust plan for consulting with the client community appropriately descibed? 

    Environment

    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?

    Additional Review Criteria - Overall

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

    Protections for Human Subjects

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

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

    Inclusion of Women, Minorities, and Children 

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

    Vertebrate Animals

    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.

    Biohazards

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

    Resubmissions

    Not Applicable.

    Renewals

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

    Revisions

    Not Applicable.

    Additional Review Considerations - Overall

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

    Applications from Foreign Organizations

    Not Applicable..

    Select Agent Research

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

    Resource Sharing Plans

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


    Authentication of Key Biological and/or Chemical Resources

    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.

    Budget and Period of Support

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

    Review Criteria for the Administrative Core

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

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

    • Has the applicant provided a well-reasoned and appropriate strategy for managing and coordinating the Center's activities and providing administrative support for both the Data Repository and Management Core and Research Resource activities?
    • Is there a well-reasoned plan for the Administrative Core to facilitate interaction between the Data Center and the other components of HHEAR (i.e., the HHEAR Coordinating Center and HHEAR National Exposure Assessment Laboratory Network)? 
    • Does the Administrative Core describe a plan to oversee improvements in HHEAR infrastructure; including the incorporation of methods developed within the Laboratory Network Hubs into other HHEAR activities?
    • Does the Administrative Core provide a plan to participate in dissemination and outreach activities to promote use of HHEAR to the scientific community?
    • Is an appropriate plan described to ensure training of HHEAR personnel as needed for standardization of collaborative protocols across components?
    • Are the Center PD/PI (Core Lead) and other leadership and staff qualified to effectively manage the Center? Have the Director(s) demonstrated an ongoing record of accomplishments related to the objectives of the Core?
    • Is the percent effort of the Director adequate?

    Review Criteria for the Data Science Resource

    Reviewers will provide an overall score for the Data Science Resource, in consideration of the following review criteria.  Individual criterion scores will not be assigned.

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

    • Does the Director of the Data Science Resource and other Resource staff cover relevant expertise (e.g., technical development of biomedical vocabulary/ontology data standards; managing a community-driven standards development process) needed to achieve goals of the Data Science Resource?
    • Are plans for identifying and implementing data and metadata standards adequate? Are they designed to allow input from other HHEAR components as well as other appropriate members of the broader scientific community?
    • Are the proposed interfaces/tools to be developed likely to facilitate access to information on data and metadata standards?
    • Will tools developed support interoperability with deposited data and other databases?
    • Are potential problems, alternative strategies, and benchmarks for success presented?
    • Will the scientific environment in which the work will be done contribute to the probability of success?
    • Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed?
    • Will the project benefit from unique features of the scientific environment or collaborative arrangements?

    Review Criteria for the Data Repository and Management Core

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

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

    • Are the Director of the Data Repository and Management Core and other Core staff well suited for the core? Have the core directors demonstrated an ongoing record of accomplishments related to the objectives of the core?
    • Does the Data Repository and Management Core propose novel strategies to enhance the ability for collection, curation, display, storage, retrieval, integration, interoperability, and reuse of data produced by the HHEAR laboratory components?
    • Has the applicant provided a well-reasoned and appropriate strategy for establishing and maintaining a data repository and data management infrastructure for HHEAR?  Are the proposed approaches user-friendly and likely to facilitate researchers' data access in support of analyses conducted within the HHEAR network?  Are potential problems, alternative strategies, and benchmarks for success presented?
    • Are plans for collaborating with the HHEAR Laboratory Network for implementing and monitoring quality control and data standards adequate?
    • Are plans for establishing data and software sharing policies and procedures adequate?  Do they appropriately account for the need to balance study participant privacy and confidentially with the overall goal of easy access and broad sharing of HHEAR generated data?
    • Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment, and other physical resources available to the investigators adequate for the project proposed? Will the Data Repository and Management Core benefit from unique features of the scientific environment or collaborative arrangements?

    Review Criteria for the Statistical Services and Analysis Resource

    Reviewers will provide an overall score for the Statistical Services and Analysis Resource, in consideration of the following review criteria.  Individual criterion scores will not be assigned.

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

    • Does the Director of the Statistical Services and Analysis Resource and other Resource staff cover the relevant expertise needed to achieve goals of the Resource, including expertise in statistics, exposure science, epidemiology, bioinformatics, and computational biology?
    • Does the application propose utilization of appropriate, cutting-edge statistical and bioinformatic methdologies to analyze data generated by HHEAR?
    • Are plans for providing statistical consultation and statistical analysis support to investigators utilizing the HHEAR Laboratory Network resources adequate? Are plans for the application and implementation of statistical, analytical, and bioinformatics methodologies adequate? Are the collaborative research efforts proposed well-justified and likely to improve understanding of the influence of environmental factors on human health?
    • Are potential problems, alternative strategies, and benchmarks for success presented?
    • Will the scientific environment in which the work will be done contribute to the probability of success?
    • Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed?
    • Has the applicant described unique approaches and/or scientific environment to facilitate collaborative projects?
    2. Review and Selection Process

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

    As part of the scientific peer review, all applications:

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

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

    Applications will be assigned  to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Environmental Health Sciences Council. The following will be considered in making funding decisions:

    • Scientific and technical merit of the proposed project as determined by scientific peer review.
    • Availability of funds.
    • Relevance of the proposed project to program priorities.  
    3. Anticipated Announcement and Award Dates

    After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. 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.

    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.

    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.

    Cooperative Agreement Terms and Conditions of Award

    The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 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 Coordination 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 webconference 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 webconference 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@mail.nih.gov

    Christopher Duncan, PhD
    National Institute of Environmental Health Sciences (NIEHS)
    Telephone: 984-287-3256
    Email: Christopher.Duncan@nih.gov

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

    Peer Review Contact(s)

    Alfonso R. Latoni, PhD
    National Institute of Environmental Health Sciences (NIEHS)
    Telephone: 984-287-3279
    Email: alfonso.latoni@nih.gov

    Financial/Grants Management Contact(s)

    James R. Williams
    National Institute of Environmental Health Sciences (NIEHS)
    Telephone: 984-287-3338
    Email: james.williams3@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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