EXPIRED
NIH's new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.
Required Application Instructions
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
Part 1. Overview Information
Part 2. Full Text of the Announcement
Section
I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission
Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
In order to fully understand children's health (i.e., from pre-conception through age 21) researchers must consider both environmental and genetic factors. Many studies conducted in the past, or in the field today, have not been designed to consider the full array of environmental exposures that may affect a child's health and wellbeing. The National Institute of Environmental Health Sciences (NIEHS) intends to promote the characterization of the exposome ( as originally defined by Christopher Wild in his 2005 Cancer Epidemiology, Biomarkers, and Prevention paper as the totality of environmental exposures from conception through development, including chemical, physical and biological stressors as well as lifestyle and social environments) in studies of children's health through the establishment of an infrastructure to enable the measurement and integration of environmental exposures. NIEHS is publishing three distinct but integrated Funding Opportunity Announcements (FOAs) that solicit a coordinated network of laboratories and statistical and data science resources to provide access to comprehensive exposure analysis that can be performed using biological samples collected in studies of children's health. This resource will be known as the Children's Health Exposure Analysis Resource (CHEAR).
CHEAR will continue the original intent of the National Children's Study to advance our understanding of the impact of environmental exposures on children's health and development. It will provide access to infrastructure for adding comprehensive exposure analysis of biological samples to existing epidemiological and clinical studies involving research in children's health. CHEAR will provide a range of services including:
The standardized laboratory analysis of samples and data and the central data repository will enable the integration of complex exposure data across multiple studies to enhance the opportunity for data pooling or comparative analyses. In many situations this will provide the otherwise unattainable power to statistically analyze the combined contributions of multiple environmental and genetic factors as determinants of children's health across a range of diseases and disorders. Furthermore, CHEAR will develop and promote data standards and common data elements (e.g., ontologies, annotation, and metadata) within the research community to facilitate inclusion of exposure analysis in children's health research.
Exposures measured by CHEAR will encompass the breadth of the exposome, the totality of biological, psycho-social, chemical, and physical exposures through the use of both comprehensive targeted and non-targeted methods of analysis. This definition of the environment goes significantly beyond the traditional definition applied to most NIEHS programs and includes exposures associated with lifestyle and the social environment to the extent that they can be measured within the infrastructure provided by CHEAR. The program will also include the characterization of associated biological response indicators to provide additional information on exposures and the impact of exposures on key biological pathways relevant for children's development. The comprehensive approach that CHEAR offers to the children's health community will enable communication among investigators leading epidemiological or clinical studies of children's health; promote collaborative research projects; leverage new data on environmental exposures for discovery of new hypotheses and associations; and identify common challenges in research on children's health and search for solutions.
CHEAR is comprised of three units:
CHEAR will provide these services to the children's health research community. The intent of the program is broad, and will cover a range of epidemiological or clinical study designs. The user community that we would expect to take advantage of this Resource could include researchers conducting children's studies that have a rich characterization of environmental exposures but which could benefit from a more extensive, exposome scale analysis, such as, but not limited to, the NIEHS and Environmental Protection Agency funded Centers for Children's Environmental Health & Disease Prevention Research (http://www.niehs.nih.gov/research/supported/dert/programs/prevention/). Conversely, studies could include projects that currently have little characterization of exposures such as Project VIVA (https://www.hms.harvard.edu/viva/index.html).
The main access to the resource will be through the Coordinating Center which will coordinate consulting services in support of study design and analysis, as well as develop and oversee a proposal process which will evaluate projects based on criteria such as the plans for incorporating or expanding exposure analysis, availability of expertise and capacity within CHEAR, and the likelihood of a high impact scientific contribution.
There is a rich and growing body of literature arising from the children's environmental health research community demonstrating that consequences of environmental exposures during critical periods in development can manifest as disease or dysfunction at any point across the human life span from infancy to old age. Children have increased risks from environmental exposures, including nutrition, stress, drugs, and environmental pollutants because their major organ systems cardiovascular, digestive, immune, nervous, and others are developing from the time of conception through adolescence. Traditionally, studies of the environmental influences on children's health and development have focused primarily on one-to-one relationships between environmental exposures and health related endpoints. Environmental health effects are complex and not a simple, one-to-one, relationship between a particular type and amount of exposure and disease. There are complicated interactions between the environment, genetics, and other factors and these interactions may affect children's health. The concept of the exposome (http://www.niehs.nih.gov/research/supported/dert/programs/exposure/) seeks to compliment traditional epidemiological approaches with an effort to integrate information on exposures to multiple (ideally all) stressors across many scales of variation (time, space, route of exposure, and biological context) and apply that global perspective on exposure to the data driven discovery of novel associations for further hypothesis driven research.
The NIH investment in children's health is significant, with a large number of important children's health studies having extensive data on clinical, biological, and genetic contributions to disease but lacking the comprehensive exposure analysis that CHEAR would provide. Similarly, there are many children's health studies already having well characterized information on a limited number of exposures which would, nonetheless, benefit from a significantly expanded exposure analysis.
Therefore, there is a need for the establishment of a focused infrastructure for comprehensive exposure analysis of biological samples to provide (1) rigorous assessment of a range of environmental exposures, xenobiotics, physiological measurements, and other biological indicators of environmental exposure and response and (2) statistical tools and data science approaches to manage and analyze all of these newly generated datasets in a cohesive and integrated manner. CHEAR will enable the children's health research community to enhance and build on their existing studies by expanding the capability or capacity of measuring both chemical and non-chemical stressors that effect children's wellbeing and development. It is expected that by implementing standard measures and analyses across studies and encouraging collaborations and networking, CHEAR will enable meta-analyses and integration of datasets of multiple cohorts and other study designs.
Other NIH resources such as the Center for Inherited Disease Research (CIDR, http://www.cidr.jhmi.edu/) have provided an opportunity to greatly expand our understanding of the genetic contributions to human disease. The CHEAR infrastructure will establish an environmental counterpart to CIDR and will enable studies to interrogate the combined effects of genes and environment in children's health. Researchers wishing to access the services must submit proposals to the CHEAR Coordinating Center for review and consideration. Analytical services will be provided to approved projects without charge to NIH funded (extramural) projects; NIH intramural projects and those not supported by NIH may access the resource through a cost-recovery effort provided analytical capacity is available.
This FOA will support the creation the CHEAR National Exposure Assessment Laboratory Network, a network of laboratory Hubs, supporting comprehensive analytical services to extend or complement the objectives of children's health studies to measure environmental exposures. The main emphasis for these Hubs is to provide capacity for targeted analyses using state-of-the-art assays specific to known compounds or stressors, such as the methods used by the CDC National Biomonitoring Program (http://www.cdc.gov/nchs/data/nhanes/nhanes_13_14/2013_MEC_Laboratory_Procedures_Manual.pdf). These Hubs will also advance the concept of the exposome by providing a comprehensive assessment of both endogenous and exogenous compounds through the application of untargeted metabolomics approaches, i.e., assessing the global complement of small molecules simultaneously. Hubs will also provide measurements of individual biological responses to provide a biological anchor for these environmental stressors. In addition, each Hub will support a Developmental Core to expand the capabilities of CHEAR by developing and validating new exposure and response measures and to investigate the use of a range of accessible biological samples for children's health studies.
Targeted Analysis is a resource that will include state-of-the-art biomonitoring of specific analytes (or classes), both endogenous and exogenous, known or suspected to affect or modify risk for health outcomes in children. Clinical Laboratory Improvement Amendments (CLIA, https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/index.html?redirect=/clia) certification is not required but may be beneficial in supporting clinical applications of children's health data.
These targeted approaches can include but are not limited to:
Laboratory capabilities needed to accomplish these goals include, at a minimum, the following:
Untargeted Analysis, the second required resource, will complement targeted analysis of specific compounds with the measurement of large sets of analytes (hundreds to thousands) simultaneously in a manner to allow the hypothesis-free (data-driven or 'agnostic') association between exposure and biological response. It is an expectation, although not a requirement, that all samples submitted for targeted analysis will also be analyzed with untargeted methodologies. Researchers utilizing the CHEAR Lab Network services may also request untargeted analysis without utilizing the targeted analysis services. Activities associated with this resource can include, but are not limited to:
Biological Response Indicators, the third required resource, will measure integrated, functional measures of individual response to environmental stressors, using established markers. Approaches may include, but are not limited to:
Developmental Core: This activity will expand the research capacity of the Hub by developing and validating new methods for future analytic services (note that these are examples and are not required). Examples of the types of activities that might be performed include:
Administrative Core: Each Hub will have an Administrative Core that will coordinate all activities with the analytical Hub including:
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Governments
Other
Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to
apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
Applicant Organizations
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
Applicants can access the SF424 (R&R) application package associated with this funding opportunity using the "Apply for Grant Electronically" button in this FOA or following the directions provided at Grants.gov.
Most applicants will use NIH's ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
The letter of intent should be sent to:
Leroy Worth
Telephone: 919-541-0670
Fax: 301-480-3722
Email: Worth@niehs.nih.gov
Component Types Available in ASSIST |
Research Strategy/Program Plan Page Limits |
Overall |
12 |
Admin Core (Use for the Administrative Core) |
6 |
Core (Use for the Developmental Core) |
12 |
Research Resource (Use for the Targeted Analysis Resource, the Untargeted Analysis Resource and the Biological Response Indicators Analysis Resource) |
12 |
Additional page limits described in the SF424 Application Guide and the Table of Page Limits must be followed.
The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.
The application should consist of the following components:
When preparing your application in ASSIST, use Component Type 'Overall'.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.
Complete entire form.
Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.
Follow standard instructions.
Other Attachments:
The filename provided for the attachment will be the name used for the bookmark in the application image. Other Attachments must not exceed 10 pages. Applications that exceed this limit will be withdrawn.
The following materials are required:
Demonstration for technical and analytical capabilities and expertise (use the file name: "Capabilities") as described below:
Enter primary site only.
A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.
Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.
A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.
The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.
A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.
Specific Aims: Outline the overall goals of the proposed Exposure Assessment Laboratory Network Hub including the specific aims of each component resource and the proposed development core.
Research Strategy: Thoroughly address the main objective of the Exposure Assessment Laboratory Network Hub, which is to create a research resource that will provide analytic services and support for measuring exposures and biological responses in studies of children's health.
The application must describe the planned organizational structure under which the Hub proposes to operate. An organizational chart showing how the group will function as a service facility must also be included.
As part of this section, describe the following elements:
Background:
Overview of the vision analytical Hub, including:
Letters of Support: Include letters of support/agreement for any collaborative/cooperative arrangements, subcontracts, or consultants. For program activities to be conducted off site, i.e., at an institution other than the applicant institution, a letter of assurance or comparable documentation, signed by the collaborator as well as the off-site institutional officials, must be submitted with the application.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:
All applications, regardless of the amount of direct costs requested for any one year, should include a Data and Resource Sharing Plan addressing the following:
The application is also expected to describe plans for:
Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
When preparing your application in ASSIST, use Component Type 'Admin Core.'
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.
Complete only the following fields:
Enter Human Embryonic Stem Cells in each relevant component.
Human Subjects: Answer only the 'Are Human Subjects Involved?' and 'Is the Project Exempt from Federal regulations?' questions.
Vertebrate Animals: Answer only the 'Are Vertebrate Animals Used?' question.
Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.
List all performance sites that apply to the specific component.
Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.
The Hub PD/PI must serve as the Administrative Core Lead and should emphasize experience and expertise in coordinating multi-project programs and facilitating research linking exposure science and epidemiology.
Applicants must provide a detailed budget, including justification for all expenditures, for the Administrative Core.
Budget forms appropriate for the specific component will be included in the application package.
Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.
The costs associated with the Administrative Core should not exceed 5% of the total Direct Costs of the Hub. The budget for the Administrative Core should include travel for the Hub PD/PI and resource directors and core leads to attend annual Steering Committee and Grantee Meetings. The budget should also include costs associated with internal communications as needed.
Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.
Specific Aims: Identify general objectives planned for the Administrative Core along with the main benchmarks that would indicate the accomplishment of these objectives.
Research Strategy: The Administrative Core will provide overall administrative and organizational oversight and management of the Hub.
As part of this section, the applicant should address the following:
Overall Hub leadership and personnel capacity that may include but is not limited to the following:
Detailed plans to support the activities of the Hub including at a minimum:
- Ability to generate Hub progress reports;
- Ability to assess and anticipate researcher needs; and
- Ability to prioritize and incorporate improvements into Hub operations and software that enhance its utility for research. (e.g., sample tracking, work flow etc.).
- Provide coordination of consulting activities on sample requirements and analyses
- Ability to ensure efficient and effective day-to-day administrative operations of the Hub; and
- Coordination with other CHEAR Components (Hubs, Coordinating Center and Data Center) as appropriate for consultative services to assist researchers in obtaining analytical services, standard data reporting, and integration of exposure data with other study outcomes.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:
Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.
When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.
When preparing your application in ASSIST, use Component Type 'Core.'
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.
SF424 (R&R) Cover (Developmental Core)
Complete only the following fields:
PHS 398 Cover Page Supplement (Developmental Core)
All instructions in the SF424 (R&R) Application Guide must be followed.
Research & Related Other Project Information (Developmental Core)
Human Subjects: Answer only the 'Are Human Subjects Involved?' and 'Is the Project Exempt from Federal regulations?' questions.
Vertebrate Animals: Answer only the 'Are Vertebrate Animals Used?' question.
Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.
Project /Performance Site Location(s) (Developmental Core)
List all performance sites that apply to the specific component.
Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.
Research & Related Senior/Key Person Profile (Developmental Core)
The Senior and Key Personnel should emphasize experience and expertise in bioanalytical chemistry and biomonitoring, clinical chemistry, and/or biochemistry, toxicology, exposure science, and biomarker development and testing.
Budget (Developmental Core)
Applicants must provide a detailed budget, including justification for all expenditures, for the Developmental Core.
Budget forms appropriate for the specific component will be included in the application package.
Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.
The costs associated with the Developmental Core should not exceed 10% of the total Direct Costs of the Hub.
PHS 398 Research Plan (Developmental Core)
Specific Aims: Identify general objectives planned for the Developmental Core along with the main benchmarks that would indicate the accomplishment of these objectives.
Research Strategy: The Developmental Core will provide support for developing new methods for exposure assessment in biological samples; develop protocols for measuring new analytes discovered and verified in the Untargeted Analysis Resource; and identify, measure, and validate new biological response indicators that can be adopted by the Biological Response Indicators Resource.
As part of this section, the applicant should address the following:
How the proposed Core will integrate the diverse expertise of the applicant team to meet the goals of the Hub.
Applications should describe detailed plans for the proposed Developmental Core which may include:
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:
Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
Planned Enrollment Report (Developmental Core)
When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.
PHS 398 Cumulative Inclusion Enrollment Report (Developmental Core)
When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.
When preparing your application in ASSIST, use Component Type 'Research Resource.'
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.
SF424 (R&R) Cover (Targeted Analysis Resource)
Complete only the following fields:
PHS 398 Cover Page Supplement (Targeted Analysis Resource)
Enter Human Embryonic Stem Cells in each relevant component.
Research & Related Other Project Information (Targeted Analysis Resource)
Human Subjects: Answer only the 'Are Human Subjects Involved?' and 'Is the Project Exempt from Federal regulations?' questions.
Vertebrate Animals: Answer only the 'Are Vertebrate Animals Used?' question.
Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.
Project /Performance Site Location(s) (Targeted Analysis Resource)
List all performance sites that apply to the specific component.
Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.
Research & Related Senior/Key Person Profile (Targeted Analysis Resource)
The Senior and Key Personnel should emphasize expertise and experience in:
Budget (Targeted Analysis Resource)
Applicants must provide a detailed budget, including justification for all expenditures, for the Research Resource Component.
Budget forms appropriate for the specific component will be included in the application package.
The costs associated with the Targeted Analysis Research Resource should represent a minimum of 60% of the total Direct Costs of the Hub. These costs include the provision of analytical services at no cost to the external research groups.
Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.
PHS 398 Research Plan (Targeted Analysis Resource)
Specific Aims: This Resource will provide the technical infrastructure for targeted analysis of environmental stressors affecting children's health. Applicants should outline specific aims to address these goals.
Research Strategy: This Resource is intended to serve as a resource to the research community by providing scientific and technical expertise to researchers seeking to expand exposure assessment in their research or clinical settings. Applicants must outline the technical functions of the Targeted Analysis Resource. This Resource will be organized around the technical work (analysis methods, protocols, data management and harmonization required to support the exposure assessment networks).
As part of this section, the applicant should address the following:
How the proposed Resource will integrate the diverse expertise of the applicant team to meet the goals of the Hub.
Customer support capacity that may include the following:
Applications should describe detailed plans for the proposed Targeted Analysis Resource which may include:
Description of plans for harmonization of methods and analyses with other CHEAR Hubs including the potential for Round Robin and Ring Trial assessments.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:
Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
Planned Enrollment Report (Targeted Analysis Resource)
When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.
PHS 398 Cumulative Inclusion Enrollment Report (Targeted Analysis Resource)
When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.
When preparing your application in ASSIST, use Component Type 'Research Resource'
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.
SF424 (R&R) Cover (Untargeted Analysis Resource)
Complete only the following fields:
PHS 398 Cover Page Supplement (Untargeted Analysis Resource)
Enter Human Embryonic Stem Cells in each relevant component.
Research & Related Other Project Information (Untargeted Analysis Resource)
Human Subjects: Answer only the 'Are Human Subjects Involved?' and 'Is the Project Exempt from Federal regulations?' questions.
Vertebrate Animals: Answer only the 'Are Vertebrate Animals Used?' question.
Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.
Project /Performance Site Location(s) (Untargeted Analysis Resource)
List all performance sites that apply to the specific component.
Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.
Research & Related Senior/Key Person Profile (Untargeted Analysis Resource)
The Senior and Key Personnel should emphasize experience and expertise in:
Budget (Untargeted Analysis Resource)
Applicants must provide a detailed budget, including justification for all expenditures, for the Research Resource component.
Budget forms appropriate for the specific component will be included in the application package.
Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.
The costs associated with the Biological Response Indicators Resource should represent 10-15% of the total Direct Costs of the Hub. These costs include the provision of analytical services at no cost to the external research groups.
PHS 398 Research Plan (Untargeted Analysis Resource)
Specific Aims: This Resource will provide the technical infrastructure for measuring biological response indicators, including validated functional assays. Applicants should outline specific aims to address these goals.
Research Strategy: This Resource is intended to serve the research community by providing scientific and technical expertise to researchers seeking to link biological response measures to exposure assessment for more comprehensive characterization of exposures and responses that contribute to health outcomes in children. Applicants must outline the technical functions of the Biological Response Indicators Resource. This Resource will be organized around the technical work (analysis methods, protocols, data management and harmonization required to support the exposure assessment networks).
As part of this section, the applicant should address the following:
How the proposed Resource will integrate the diverse expertise of the applicant team to meet the goals of the Hub.
Applications should describe detailed plans for the proposed Biological Response Indicators Resource which may include:
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:
Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
Planned Enrollment Report (Untargeted Analysis Resource)
When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.
PHS 398 Cumulative Inclusion Enrollment Report (Untargeted Analysis Resource)
When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.
When preparing your application in ASSIST, use Component Type 'Research Resource.'
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.
SF424 (R&R) Cover (Biological Response Indicators Resource)
Complete only the following fields:
PHS 398 Cover Page Supplement (Biological Response Indicators Resource)
All instructions in the SF424 (R&R) Application Guide must be followed.
Research & Related Other Project Information (Biological Response Indicators Resource)
Human Subjects: Answer only the 'Are Human Subjects Involved?' and 'Is the Project Exempt from Federal regulations?' questions.
Vertebrate Animals: Answer only the 'Are Vertebrate Animals Used?' question.
Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.
Project /Performance Site Location(s) (Biological Response Indicators Resource)
List all performance sites that apply to the specific component.
Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.
Research & Related Senior/Key Person Profile (Biological Response Indicators Resource)
The Senior and Key Personnel should emphasize experience and expertise in:
Budget (Biological Response Indicators Resource)
Applicants must provide a detailed budget, including justification for all expenditures, for the Research Resource component.
Budget forms appropriate for the specific component will be included in the application package.
Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.
The costs associated with the Biological Response Indicators Resource should represent 10-15% of the total Direct Costs of the Hub. These costs include the provision of analytical services at no cost to the external research groups.
PHS 398 Research Plan (Biological Response Indicators Resource)
Specific Aims: This Resource will provide the technical infrastructure for measuring biological response indicators, including validated functional assays. Applicants should outline specific aims to address these goals.
Research Strategy: This Resource is intended to serve the research community by providing scientific and technical expertise to researchers seeking to link biological response measures to exposure assessment for more comprehensive characterization of exposures and responses that contribute to health outcomes in children. Applicants must outline the technical functions of the Biological Response Indicators Resource. This Resource will be organized around the technical work (analysis methods, protocols, data management and harmonization required to support the exposure assessment networks).
As part of this section, the applicant should address the following:
How the proposed Resource will integrate the diverse expertise of the applicant team to meet the goals of the Hub.
Customer support capacity that may include the following:
Applications should describe detailed plans for the proposed Biological Response Indicators Resource which may include:
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:
Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
Planned Enrollment Report (Biological Response Indicators Resource)
When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.
PHS 398 Cumulative Inclusion Enrollment Report (Biological Response Indicators Resource)
When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.
Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH's electronic system for grants administration.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues.
Important reminders:
All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization's profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
In order to expedite review, applicants are requested to notify the NIEHS Referral Office by email at 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.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.
Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Hub to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the Hub proposed).
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a Hub that by its nature is not innovative may be essential to advance a field.
Is the proposed Hub needed to achieve the goals of the children's health research community it proposes to serve? Will coordinated services offered facilitate or expedite research that would be delayed or infeasible if conducted as independent projects? What advantages will the Hub bring to the research community? Does the proposed plan describe a laboratory Hub that will provide extensive and efficient analytical measures of exposure and response to researchers examining children's health? Are future directions and needs of the research field addressed with appropriate consideration to adapting or modifying new measures of environmental, lifestyle and other non-genetic factors for studies of children's health? Are the plans for the laboratory Hub to move towards a more comprehensive capability for measuring exogenous and endogenous exposures on an exposome scale addressed?
Are the PD(s)/PI(s) and other personnel well suited to their roles in the Hub? Do they have appropriate experience and training, and have they demonstrated an ongoing record of excellence in supporting community-wide research projects? If the Hub is collaborative or multi-PD/PI, do the investigators have complementary and integrated skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the Center described? Are the investigator's experience and expertise with analytical services, assay development, and processing of relevant biological samples from epidemiological studies appropriate? Is the investigator's experience in developing and validating novel approaches to exposure assessment well documented?
Does the application propose novel organizational concepts, management strategies, or instrumentation in providing services to the children's health research community? Are the concepts, strategies, or instrumentation novel to children's health research or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts, management strategies or instrumentation proposed? Are novel approaches being used by the investigators to adapt or develop new methods for measuring analytes that reflect exposures to environmental and lifestyle factors in children's studies? Does the proposed plan allow for novel, validated methods to be incorporated into the Targeted Analysis Resource during the project period?
Are the overall design, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research community the Hub will serve? Are potential problems, alternative strategies, and benchmarks for success presented? If the Hub is in the early stages of operation, will the strategy establish feasibility and will particularly risky aspects be managed? Does the proposed plan create a sufficiently high likelihood of successful adaptation and scale-up of existing methods for adoption by diverse children's health studies? Will the proposed effort support the integration of targeted and untargeted exposure assessment with biological response indicators?
Will the institutional environment in which the Hub will operate contribute to the probability of success in facilitating the research community it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Hub proposed? Will the Hub benefit from unique features of the institutional environment, infrastructure, or personnel? Are the existing instrumentation and expertise adequate for continued support and expansion of the laboratory Hubs? If additional instrumentation dedicated to the project is needed, can this be acquired rapidly and within the budget for immediate use in the laboratory Hub? Are there sufficient commitments of facilities, infrastructure, and other resources to allow for the full-scale operation throughout the project period?
As applicable for the Hub proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
When the proposed Hub involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Not Applicable
Not Applicable
Not Applicable
As applicable for the Hub proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Not Applicable
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genomic Data Sharing Plan .
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Reviewers will provide an overall score for the Administrative Core, in consideration of the following review criteria. Individual criterion scores will not be assigned.
Reviewers will specifically assess the likelihood that the proposed resources and oversight by this Core will provide and exert a sustained, effective, influence in the field of children's environmental health. Consideration of the following bullets should also be included in the overall assessment:
Reviewers will provide an overall score for the Development Core, in consideration of the following review criteria and additional review criteria. Individual criterion scores will not be assigned.
Reviewers will consider the following in determining overall merit of the Development Core. An application does not need to be strong in all categories to be judged likely to have major scientific impact
Reviewers will evaluate the following resource and provide an overall score based on the individual review criteria for each required resource. Individual criterion scores will not be assigned.
Reviewers should consider the individual bulleted elements in their overall assessment in terms of scientific and technical merit, and in providing overall impact score:
Reviewers will evaluate the following resource and provide an overall score based on the individual review criteria for each required resource. Individual criterion scores will not be assigned.
Reviewers should consider the individual bulleted elements in their overall assessment in terms of scientific and technical merit, and in providing overall impact score:
Reviewers will evaluate the following resource and provide an overall score based on the individual review criteria for each required resource. Individual criterion scores will not be assigned.
Reviewers should consider the individual bulleted elements in their overall assessment in terms of scientific and technical merit, and in providing overall impact score:
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:
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:
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee's business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
Cooperative Agreement Terms and Conditions of Award
The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in, and otherwise working jointly with, the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.
The PD(s)/PI(s) will have the primary responsibility for:
The PD/PI (or multiple PDs/PIs, if applicable) will have primary authority and responsibility to define objectives and approaches, and to plan, conduct, analyze, and report back results, interpretations, and conclusions of projects conducted. The PD/PI assumes responsibility and accountability to the applicant organization officials and to the NIH for the performance and proper conduct of the CHEAR component in accordance with terms and conditions of the award.
All PD(s)/PI(s) of CHEAR components (Laboratory Network, Data and Statistical Analysis Resource, and Coordinating Center) will have the primary responsibility for:
The PD/PI responsible for the CHEAR Coordinating Center will have the following additional responsibilities:
Intellectual Property Considerations:
Awardees will be responsible for relevant intellectual property oversight that will include:
NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
One or more designated NIH staff, acting as Project Scientist(s), will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards. If more than one Project Scientist is identified on any CHEAR component, one will be assigned as the Lead Project Scientist. The NIH Project Scientist(s) and other substantially involved NIH program staff members will assist CHEAR by:
NIH staff members who are substantially involved in the scientific activities (e.g., publications) of the CHEAR will not attend peer review meetings of renewal and/or supplemental applications.
In addition, an NIH Program Director acting as the Program Official will be responsible for the normal scientific and programmatic stewardship of the award, and will be named in the award notice. If this individual becomes substantially involved in the CHEAR activities, he/she will not attend peer review meetings of renewal and/or supplemental applications or will seek NIH waiver if such participation is essential.
The NIH reserves the right to adjust funding, withhold, suspend, or terminate the support to the CHEAR awardee and/or member institutions that are unable to meet the performance requirements set forth in these Terms and Conditions of Award, or significantly change the level of performance.
Areas of Joint Responsibility include:
CHEAR Steering Committee. The CHEAR Steering Committee will serve as the main governing board for the CHEAR Program. The Steering Committee will consist of the following voting members:
NOTE: Each voting member noted above representing CHEAR will have one vote (including those individuals who may have multiple responsibilities).
All NIH representatives will collectively have one vote.
The PD/PI of the Coordinating Center will serve as Steering Committee Chair the first year of the program; thereafter, a Steering Committee Chair will be elected every twelve months from amongst the Steering Committee members by the committee. An individual may continue serving as Chair for more than one year if all committee members agree. NIH staff cannot serve as Steering Committee Chair.
In the event that the Steering Committee cannot agree on critical aspects, such as common protocols, then NIH Staff will have final authority to implement proposed recommendations. All activities must comply with NIH, DHHS, and Federal Guidelines.
Additional individuals may be added to the CHEAR Steering Committee as non-voting members by a decision of the existing voting members. These additional non-voting members may include, for example, other NIH Program Staff members, and/or Program Staff members from other Federal Agencies (e.g., Centers for Disease Control and Prevention, U.S. Food and Drug Administration). PD(s)/PI(s) of projects using the CHEAR infrastructure may also be invited when their presence is needed.
Other guidelines for the Steering Committee, such as a quorum, frequency, duration, and type of meetings (in-person, remote), will be determined at its initial meeting.
The CHEAR Steering Committee will meet twice per year in person and monthly via phone conference. Applicants should budget for in-person meetings. The first meeting will occur in Research Triangle Park, NC. Subsequent meetings will be held at CHEAR awardee locations to be determined.
The CHEAR Steering Committee will have primary responsibility for:
The CHEAR Steering Committee may also form subcommittees, each with a specific functional area of oversight as defined in the application.
Scientific Consulting Panel. A Scientific Consulting Panel will operate as an evaluative subcommittee to the NIH, advising NIH and providing technical expertise to the entire CHEAR. This panel will comprise scientific experts not affiliated with the CHEAR institutions and may include scientists from academic and other research institutions as well as from NIH, other Federal Agencies, pediatricians and clinical staff, and relevant stakeholders. Members of the Scientific Consulting Panel will be selected by the NIH in consultation with the CHEAR Steering Committee. The Scientific Consulting Panel will be charged with the following activities:
Dispute Resolution:
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel comprised of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.
Progress reports for multi-year funded awards are due annually on or before the anniversary of the budget/project period start date of award. The reporting period for multi-year funded award progress report is the calendar year preceding the anniversary date of the award. Information on the content of the progress report and instructions on how to submit the report are posted at http://grants.nih.gov/grants/policy/myf.htm. In addition, this program will require interim progress reports to be filed semi-annually and reporting on activities in the preceding six month period.
A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.
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David M. Balshaw, PhD
National Institute of Environmental Health Sciences (NIEHS
Telephone: 919-541-2448
Email: Balshaw@mail.nih.gov
Claudia Thompson, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-4638
Email: Claudia.Thompson@nih.gov
Alfonso Latoni, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-7571
Email: Alfonso.Latoni@nih.gov
Linda Bass, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-1307
Email: Bass@niehs.nih.gov
Leroy Worth, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-0670
Email: Worth@niehs.nih.gov
George Tucker
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-2749
Email: TuckerG@mail.nih.gov
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.