Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute of Environmental Health Sciences (NIEHS)
Funding Opportunity Title	Limited Competition: NIH Competing Revision Awards for Creating Virtual Consortium for Translational/Transdisciplinary Environmental Research (ViCTER)(R01)
Activity Code	R01 Research Project Grant
Announcement Type	Reissue of PAR-10-030
Related Notices	December 20, 2013 - This PAR has been reissued as PAR-14-050.
Funding Opportunity Announcement (FOA) Number	PAR -11-046
Companion FOA	None
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestics Assistance (CFDA) Number(s)	93.113
FOA Purpose	The purpose of the ViCTER program is to foster and promote transdisciplinary collaborations and/or translational research efforts among basic (technology and mechanism oriented), clinical (patient-oriented) and population-based researchers and other individuals with expertise relevant to environmental health who have come together in common interest around a particular environmental stressor(s) of interest. For the purposes of this FOA, transdisciplinary research is defined as the use of cross-disciplinary methods, insights, and research approaches that would not have occurred with a traditional uni-disciplinary investigation and translational research is defined as research that stimulates the bidirectional flow of information across the spectrum of in vitro, lower animal models, higher animal models, human population or clinical-based research in order to provide data useful for the prevention and intervention of human disease. The goal of the Consortia Program is to support the exchange of knowledge and resources among collaborators to carry out small high-risk, high-reward transdisciplinary and/or translational research projects with the potential to lead to sustained collaborative efforts addressing key issues to improve human health in those areas where environmental factors are known or expected to influence the development or progression of disease. Each virtual consortium will consist of an NIEHS-funded researcher (lead applicant), who will serve as the Principal Investigator (PI) and overall coordinator of the consortia, and two new collaborators. The Competing Revision application should include one to two new specific aims for the current NIEHS-funded research project and one to two specific aims from each of the new collaborators that will expand the scope of the current project with the goal of making the research more transdisciplinary and/or translational.

Posted Date	November 29, 2010
Open Date (Earliest Submission Date)	January 22, 2011
Letter of Intent Due Date	January 22, 2011, January 22, 2012, January 22, 2013
Application Due Date(s)	February 22, 2011, February 22, 2012, February 22, 2013 , by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	May 2011, May 2012, May 2013
Advisory Council Review	October 2011, October 2012, October 2013
Earliest Start Date(s)	November 1, 2011, November 1, 2012, November 1, 2013
Expiration Date	February 23, 2013
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (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.

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

Environmental health sciences research has traditionally been organized into broad areas of scientific interest with limited integration across disciplines. This approach is reflected in the diverse research activities supported by the National Institute of Environmental Health Sciences (NIEHS) (http://tools.niehs.nih.gov/portfolio/). NIEHS currently supports research to understand the impact of environmental agents on human health using in vitro cell culture systems, in vivo animal exposures, population-based studies that examine associations between exposures and potential health implications, patient-oriented studies that focus on direct health effects of environmental stressors and susceptibility, and research-community partnerships to promote the translation of findings from environmental health science research into public health action. The application of new technological and methodological advances to environmental health research has provided unprecedented insight into the dynamic and complex nature of biological systems. Investigators in the field of environmental health sciences have started to integrate these tools into their investigations to gain a more global view of the relationship between exposure and disease initiation and progression, how genetic variability impacts susceptibility to environmental stressors, and ways to effectively translate and disseminate complex research findings to the public. However, these efforts are currently restricted to a few laboratories and institutions due to availability of resources, expertise or access to technology. Many investigators could greatly benefit from a more coordinated and integrated approach to facilitate translational research between basic laboratory-based research, population studies, and clinical programs.

NIEHS recognizes that to achieve an integrated translational and/or transdisciplinary research agenda, many experimental approaches need to be employed in a systematic and sustained fashion. To a limited extent, many of NIEHS larger programs such as the Centers for Children’s Environmental Health Research, Breast Cancer and the Environment Research Centers and Centers for Neurodegeneration Science have moved in this direction by requiring both basic and human-based translational research as well as community outreach and education cores. However, these programs are expensive, focused on specific environmental health research topics and cannot be expanded to other equally important environmental exposures or resulting diseases in a time of fiscal restraint.

This Funding Opportunity Announcement (FOA) with set-aside funds and a special review () encourages submission of Competing Revision applications from current NIEHS-funded R01 awardees to develop and implement a Virtual Consortium for Translational/Transdisciplinary Environmental Research (ViCTER) for purposes of this FOA, translational research is defined as research that involves scientists and public health professionals from the same or multiple disciplines working interactively on a common problem to stimulate the bidirectional flow of information across the spectrum using some combination of in vitro systems, rodent models, higher models (sheep/primate), human epidemiological or clinical research, as well as research dissemination and public health action. Transdisiplinary research is defined as research that involves scientists and public health professionals from multiple disciplines working interactively on a common problem to develop novel cross-disciplinary methods, insights, and research approaches that would not have occurred with a traditional uni-disciplinary investigation. For the purposes of this FOA, applications may be translational or transdisciplinary and need not be both.

Scientific Knowledge to be Achieved

This Initiative will allow investigators to expand the scope of a current ES funded R01 by developing new research teams that would create a virtual consortium to include new perspectives, such as basic mechanistic, clinical, epidemiological, computational, engineering and/or health risk communication approaches, expanding the translational and/or transdisciplinary nature of the grants with the goal of improving their impact on public health. Specifically, the NIEHS expects to foster a better understanding of the mechanism of disease/dysfunction in those areas where environmental factors are known or expected to influence the development or progression of disease.

Research Objectives Results and Outcomes

The objective of this program is to develop virtual consortia that will foster transdisiplinary collaboration and/or promote translational research efforts among basic (technology and mechanism oriented), clinical (patient-oriented) and population-based researchers and other individuals with expertise relevant to environmental health sciences. The ultimate goal for creating this Virtual Consortia Program is to support the exchange of knowledge among individuals from this diverse set of disciplines and accelerate the translation of scientific research into meaningful improvements in human health in those areas where environmental factors are known or expected to influence the development or progression of disease. This Virtual Consortium Program is expected to stimulate the development and application of novel approaches for understanding the role of environmental chemicals in the etiology of disease as well as the diagnosis, prevention, and treatment/intervention of harmful exposures, and an understanding of the etiology of diseases and disorders that will impact clinical or public health practice. It is envisioned that these new Virtual Consortia will create new research teams that include new perspectives, such as basic mechanistic, clinical, epidemiological, computational, engineering, and/or health risk communication approaches, to focus on a central theme relevant to environmental exposures or exposure-related diseases. Applicants must demonstrate the translational and/or transdisciplinary nature of the research aims proposed within the Competing Revision application and describe how the creation of the consortium will lead to synergy (the whole being greater than the sum of its parts) among the individual research projects. Because of the funding constraints of the projects in the VICTER, it is anticipated that the subprojects in the consortium will be similar to interrelated small grants in that they can be exploratory in nature, not require preliminary data and be high risk/high payoff.

One of the critical components of the ViCTER Program is their virtual aspect, which allows researchers at remote locations to form a consortium to integrate their research through the development of a virtual center that houses the ViCTER, a consortium director (also referred to as the Principal Investigator of the consortium or lead applicant in this FOA), regular (at least monthly) conference calls and annual update meetings.

The NIEHS anticipates a variety of possible results and outcomes from this ViCTER program, including but not limited to the following:

• Original peer-reviewed papers and synthesis reports.
• Generation and analysis of complex biological, environmental data which provide insight into the interaction of these domains and their influence on disease presentation.
• Addition of the use of state of the art technologies (genomics, epigenomics, metabolomics) to understand the role of environmental exposures in disease and disease susceptibility.
• An improved understanding of the role of single and multiple exposures across the lifespan in the etiology and progression of disease.
• New insights into integration of environmental effects data across tissues and time leading to disease.
• New insights into the role of environmental exposures in diseases linked by a common underlying pathway(s).
• The development and application of biomarkers of exposure, susceptibility and/or effect which illuminate health risks.
• The development and application of novel tools and methods to help determine exposure risk and/or better predict health outcomes with greater specificity.
• The use of developed tools and methods for improved analysis of health risks to inform decision-making at the state and local levels.
• The use of basic science and/or population-based research findings in policy decision-making arenas to limit environmental exposures that are potentially harmful to health.
• Advances in cross-disciplinary training in environmental health based on the latest scientific discoveries.

NIEHS particularly encourages applicants to propose new aims that are high risk/high reward which if achieved are likely to contribute significantly to the ViCTER program’s environmental health science field of focus.

Consortium Structure and Activities Supported

Each ViCTER program will consist of three participants per consortium (including the lead applicant plus two new collaborators). A new collaborator is defined as someone whom the lead applicant has not published scientific research papers with in the last five years (excluding reviews, white papers etc.) In addition only one of the collaborators can be at the same Institution as the lead applicant. The lead applicant must be a current NIEHS-supported R01 awardee, and is responsible for providing the environmental health science focus of the Virtual Consortium Program and housing the virtual consortium. The lead applicant will partner with two new collaborators (no prior or current research funding on their part is needed) to develop, write and implement research projects (at least one new aim per participant) that are thematically related and will expand the science, develop new ideas, and foster collaboration, integration and translation between ViCTER participants. All research projects must fall within the environmental health theme or focus of the proposed consortium and must be new (i.e., consortium members should not have published an original research article together on these specific topics previously). Again, the consortium members should not have published with the PI within the last 5 years on any research topic.

The roles and requirements of the lead applicant and new collaborators are outlined below.

The lead applicant must:

• Be a current NIEHS-supported R01 awardee with a minimum of 2 years of non-competing funding remaining on the active grant at the start date of its noncompeting renewal for the Competing Revision application. Please note the minimum is 3 years of non-competing funding remaining if requesting a project period of 3 years.
• Write a Competing Revision application to expand the scope of the parent R01 grant, providing the central environmental health sciences theme or focus of the proposed ViCTER consortia.
• Propose one to two new aims for the parent grant:
• Demonstrate the translational and/or transdisciplinary nature of the research aim(s) proposed within the Competing Revision application.
• Demonstrate how the new aims relate to and expand the original aims of the parent grant and how they will contribute to the central environmental health sciences theme or focus (including providing proof of principle for a more comprehensive collaboration.).
• Describe how the creation of the consortium will lead to synergy among the individual research projects each participant proposes.
• Describe an administrative plan to, at a minimum, organize and hold regular teleconferences and at least yearly face-to-face meetings for ViCTER participants

Each new collaborator must:

• Propose one to two research aims related to the central environmental health sciences theme or focus of the ViCTER program that will help fulfill the translational and/or transdisciplinary nature of the program.
• Demonstrate the translational and/or transdisciplinary nature of the research aim(s) proposed within the Competing Revision application.
• Describe how membership in the consortium will lead to synergy that would not be possible conducting the individual research project alone.

Applicants can request support for a variety of activities, including but not limited to, the sharing of tissues, assays, animals, and biosamples; coordination of bioinformatics for sample analysis; coordination of analyses; cross training of students, postdoctoral fellows and technicians among labs; research dissemination and community outreach activities; and yearly grantee meeting.

Each consortium member must contribute to the intellectual development of the subprojects. Providing tissue samples, reagents or simple analyses is of itself not sufficient.

Length of the Competing Revision Grant Period

The length of award will depend on needs and time remaining on the parent application. The total project period for an application submitted in response to this funding opportunity may be 2 or 3 years. However, the number of years requested cannot exceed the amount of time remaining in the parent grant period at the earliest anticipated start date (the date of the start of the noncompeting renewal). For example, an application that will have more than or equal to 3 years left in the project period of the parent grant on the start date of the noncompeting renewal may request a project period of 2 or 3 years. Conversely, an application with 2 years left in the project period of the parent grant at the earliest anticipated start date (start date of noncompeting award) may only request a project period of 2 years. Applicants with less than 2 years remaining in the project period of the parent grant at the earliest anticipated start date are not eligible to apply.

Allocation of Funds among Collaborators

Applicants can request up to $250,000 in direct costs per year, $25,000 of which is to support the applicant organization’s costs associated with the coordination of the ViCTER program. The remainder of the $225,000 may be allocated to 1) the lead applicant for the one to two new specific aims that are proposed to expand the scope of the current grant, and 2) for the one to two specific aims of each of the two subproject collaborations for the other ViCTER participants. While the allocations of the $225,000 may be predicated by need, no one subproject should be less than $50,000 direct cost. The activities of each new collaborator and related costs must be separately identified and justified in the budget justification.

Examples of possible ViCTER projects include, but are not limited to:

• Environmental health scientist working on a particular toxicant and effects on reproduction in a higher animal model (PI of consortium) develops a consortium with two other environmental health scientists examining the site and mechanism of the same toxicant on the same tissues, one working in a rodent model and another using an in vitro system to understand the mechanism across species to predict the mechanism in humans.
• Environmental epidemiologist (PI of consortium) following a cohort of children to examine the impact of multiple endocrine disruptors (EDs) on growth develops a consortium with an environmental scientist who has developed an assay to measure the overall estrogenic effect of complex ED mixtures to estimate the total estrogenic impact of real life complex exposure patterns observed in the epidemiological cohort and a community outreach program to alert the local community of the potential health hazards of the environmental agents on children.
• Environmental epidemiologist (PI of consortium) conducting an observational study of robust association between exposure to an ambient air pollutant and a specific disease develops a consortium with a clinician to understand the potential role of known susceptibility genes in predisposition to the disease process, and with a basic scientist exploring mechanistic studies in vitro or rodent models to integrate their findings to develop biomarkers or potential interventions.
• Environmental health scientist (PI of consortium) working on chemical exposure-induced obesity in a rodent model develops a consortium with another scientist working on the physiology and endocrinology of diabetes in a rodent model and a scientist who is an expert in brain signaling and obesity to understand the effects of the environmental chemical on critical pathways involved in obesity and diabetes development.
• Environmental health scientist (PI of consortium) examining the effects of chemical X on disease Y in human epidemiology study develops a consortium with an animal researcher examining adult exposure to X and disease Y, and an animal researcher studying developmental exposures to X and disease Y in order to better understand metabolism, effect of timing and doses and mechanism of chemical X on disease Y across species.
• An environmental health scientist (PI of consortium) measuring the epigenome of a tissue in response to chemical X develops a consortium with two other environmental health researchers measuring the epigenome in response to chemical X in other glands/tissues, in order to develop a comprehensive epigenome of chemical X across tissues.

Of note, the researcher designated as the PI of the consortium in the above examples was chosen arbitrarily (e.g., any of the participants could in theory be the PI). The only requirement is that the PI of the consortium holds the current R01 grant award that will serve as the parent grant for the Competing Revision application.

Required Components

The requirements of the proposed ViCTER Consortia are as follows:

• A current NIEHS-supported R01 awardee (lead applicant) provides the environmental health focus (environmentally relevant disease and/or toxicant) and houses the Virtual Consortium. The lead applicant must have a minimum of 2 years of non-competing funds remaining at the anticipated start date for this FOA (start of the noncompeting renewal in FY 2012) if requesting a project period of 2 years or a minimum is 3 years if requesting a project period of 3 years.
• The lead applicant will write a Competing Revision application to expand the scope of the originally proposed research by proposing new aims that will involve two transdisciplinary collaborators and/or that will stimulate translational research (either transdisciplinary or translational or a combination is acceptable).
• The two new collaborators, who are not required to have an active grant of their own for this program, each write a one to two aim supplement to the parent ES grant expanding on its research to develop new ideas and promote collaboration, transdiscipline and/or translation and synergy.
• Annual face-to-face meetings and regular (at least monthly) teleconferences to coordinate the research.
• Since the goal is to develop virtual consortia, only two of the consortium members (either the PI and one collaborator, or two collaborators and not the PI) may be at the same institution. In addition, the goal is to develop new collaborations. The consortium members should not have published with the PI within the last 5 years.
• All proposed research projects must be new (i.e., consortium members should not have published an original research article together on these specific topics previously).
• See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

In summary, the purpose of the ViCTER program is to foster and promote transdisciplinary collaborations and/or translational research efforts among basic (technology and mechanism oriented), clinical (patient-oriented) and population-based researchers and other individuals with expertise relevant to environmental health who have come together in common interest around a particular environmental stressor(s) of interest. For the purposes of this FOA, transdisciplinary research is defined as the use of cross-disciplinary methods, insights, and research approaches that would not have occurred with a traditional uni-disciplinary investigation and translational research is defined as research that stimulates the bidirectional flow of information across the spectrum of in vitro, lower animal models, higher animal models, human population or clinical-based research in order to provide data useful for the prevention and intervention of human disease.

The goal of the Consortia Program is to support the exchange of knowledge and resources among collaborators to carry out small high-risk, high-reward transdisciplinary and/or translational research projects with the potential to lead to sustained collaborative efforts addressing key issues to improve human health in those areas where environmental factors are known or expected to influence the development or progression of disease. Each virtual consortium will consist of an NIEHS-funded researcher (lead applicant), who will serve as the Principal Investigator and overall coordinator of the consortia, and two new collaborators. The Competing Revision application should include one to two new specific aims for the current NIEHS-funded research project and one to two specific aims from each of the new collaborators that will expand the scope of the current project with the goal of making the research more transdisciplinary and/ or translational.

Funding Instrument	Grant
Application Types Allowed	Revision The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	NIEHS intends to commit $2.5 million in FY2012 to fund 5-7 new Competing Revision awards in response to this announcement. Awards issued under this FOA are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications. Future year amounts will depend on annual appropriations.
Award Budget	Application budgets are limited to $250,000 direct cost, but need to reflect actual needs of the proposed project.
Award Project Period	The total project period for an application submitted in response to this funding opportunity may be 2 or 3 years, but the number of years requested cannot exceed the amount of time remaining in the project period of the parent grant at the earliest anticipated start date (i.e. from the date in 2012 of the budget period start date for noncompeting renewal of the parent grant.) For example, an application that will have more than or equal to 3 years left in the project period start date of the parent grant in 2012, may request a project period of 2 or 3 years. Conversely, an application that will have 2 years left in the project period of the parent grant may only request a project period of 2 years. Applicants with less than 2 years remaining in the project period of the parent grant at anticipated start date are not eligible to apply. Direct costs are limited to $250,000. Two-year applications are particularly encouraged.

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:

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions

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
• Non-domestic (non-U.S.) Entities (Foreign Organizations)

Foreign (non-U.S.) components of U.S. Organizations are allowed.

This is a limited competition made available to current R01 grantees funded by NIEHS with at least 2 years left in the project period of the parent grant at the anticipated start date in FY2012 of the noncompeting renewal. Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI 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.

Eligible Principal Investigators (PIs) will hold a current NIEHS-funded R01 award (parent grant) with greater than 2 years of non-competing funding remaining at the anticipated start date in FY2012 for this FOA.

Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

• Central Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually
• Grants.gov
• eRA Commons

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) 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 SF 424 (R&R) Application Guide.

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

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

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed.

Only one ViCTER application may be submitted from a single R01. Resubmissions are not allowed

Applications must have the following characteristics

• The title provided in the Descriptive Title of Applicant s Project field on the SF424 (R&R) cover must exactly match (including punctuation and spacing) the title of the parent grant.
• The Project Director/Principal Investigator (PD/PI) must be the same as the PD/PI on the parent award. For Multiple PD/PI parent awards, the Contact PD/PI must be the PD/PI listed on the revision request. Revisions allow a change in the Multiple PD/PI team as well as a conversion from a single PD/PI to multiple PD/PI. However, applicants must include a multiple PD/PI Leadership Plan with the revision application.
• Applicants must submit a budget using the same budget format as was used for the current award (i.e., use the SF424 (R&R) PHS398. Modular Budget if the parent grant was submitted using a modular budget or the Research & Related Budget if the parent grant used a detailed budget).
• Provide a one-page Introduction that describes the nature of the revision and how it will expand the scope of the specific aims, research design, and methods of the current grant.
• A current NIEHS-supported R01 awardee (i.e., lead applicant) provides the environmental health focus (environmentally relevant disease and/or toxicant) and houses the Virtual Consortium.
• The requested grant supplement period cannot exceed the project period of the parent grant (i.e., the lead applicant must have a minimum of 2 years of non-competing funding remaining at the start date of the noncompeting renewal for this FOA (the minimum is 3 years if requesting a project period of 3 years).
• The lead applicant writes a Competing Revision application to expand the scope of the originally proposed research by proposing new aims that will involve two transdisciplinary collaborators and/or that will stimulate translational research (either transdisciplinary or translational or a combination is acceptable).
• The two new collaborators each write one to two aims to expand the research of the parent ES grant. These aims are to develop new ideas and promote collaboration that are transdisciplinary and/or translational and synergistic.
• The application includes plans and funds to support annual face-to-face meetings and regular (at least monthly) teleconferences to coordinate the research.
• Since the goal is to develop virtual consortia, only two of the consortium members (either the PI and one collaborator, or the two collaborators) may be at the same institution. Ultimately, the goal is to develop new collaborations.

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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 research
Name, address, and telephone number of the PD(s)/PI(s)
Names of other key personnel
Participating institutions
Number and title of this funding opportunity

The letter of intent should be sent to:

Janice Allen, Ph.D.
Scientific Review Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, K3-03
Keystone Building, Room 3080
Research Triangle Park, NC 27709
Phone: (919) 541-7556
Fax: 301-451-5715
Email: [email protected]

The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for application submission. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.

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

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

Resource Sharing Plan

Not Applicable.

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

Foreign (non-US) organizations must follow policies described in the NIH Grants Policy Statement, and procedures for foreign organizations described throughout the SF424 (R&R) Application Guide.

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

Applicants are responsible for viewing their application 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 SF 424 (R&R) Application Guide. Paper applications will not be accepted.

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

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(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 Central Contractor Registration (CCR). 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 by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

Biographical Sketch for PD/PI and all new Senior/Key Personnel (those who are additions on the revision project). Applicants must include an updated biographical sketch for the PD/PI and new Senior/Key Personnel, using the forms which are available PDF http://grants.nih.gov/grants/funding/phs398/biosketch.pdf). There is no need to repeat information previously provided for other Senior/Key Personnel.

All application attachments must be in PDF format.

Budget

Applicants can request up to $250,000 total in direct costs per year. $25,000 may be budgeted to support applicant organization’s costs associated with the coordination of the ViCTER program. $225,000 may be apportioned among the PI and the two collaborators to support the one to two new specific aims that are proposed to expand the scope of the current grant and the collaborations with other ViCTER participants on an as need basis but no project may get less than $50,000. The activities of each new collaborator and related costs must be separately identified and justified in the budget justification.

The budget provided for the revision application must match the same format as the budget provided in the parent application (i.e., either modular or detailed budget). For instance, if the parent application was submitted using the Modular budget component, then the revision application must also use the Modular budget component. Applicants should use the guidelines outlined in the SF424 (R&R)

Applicants should budget to attend two annual meetings of ViCTER investigators at NIEHS.

PD/PI Credential (e.g., Agency Login)

The NIH requires the PD(s)/PI(s) to fill in his/her Commons User ID in the PROFILE Project Director/Principal Investigator section, Credential log-in field of the Research & Related Senior/Key Person Profile component.

Applicants for a ViCTER should use the following guidance in writing a research plan that is unique to the ViCTER program. Reviewers should focus on the new specific aims being proposed for the ViCTER consortium rather than the work previously proposed for the parent grant. That being said, it is appropriate for reviewers to evaluate the new specific aims with respect to how well they EXTEND the scope of the parent grant to be more translational and/or transdisciplinary in nature.

Introduction (1 page):

Applications must open with a brief description of the original (parent grant) aims followed by a statement of objectives of the ViCTER Program (Introduction to application). The application should:

Describe the major theme of the Center, its goals and objectives, background information and the overall importance of the research to NIEHS. This should include the central theme of focus on a disease(s) and primary environmental stressors of study and the overall hypotheses to be tested. The applicant must provide a compelling rationale for the environmental significance of the disease(s) of interest. The program should be viewed as a group of interrelated research projects, each of which is individually scientifically meritorious but is also complementary and synergistic to the other projects, and related to the overall theme developed for the ViCTER.

Describe the rationale for the total proposed program including the rationale for expansion of the original research plan. Explain the strategy for achieving the expected results and outcomes defined for the overall program and how each research project relates to that strategy. Highlight how the findings of the research efforts will impact clinical and public health practice.

Indicate and describe any collaborative arrangements between investigators in the group and the anticipated unique advantages that would be gained by the interdisciplinary/transdisciplinary approach proposed for the research being conducted.

Explain how different components of the organization, including key personnel, will interact, why they are essential to accomplishing the overall goal of the research, and how combined resources create capabilities that are more than the sum of the parts. Very clear evidence that the key personnel will collaborate effectively must be presented in the application.

Describe the new specific aims for the current NIEHS-funded research project as well as a brief description of the specific aims from each of the new collaborators

Show how these aims which are intended to significantly expand the scope of the current projects will be integrated.

Describe how the specific aims relate to overall theme of the ViCTER and what are the collaborative arrangements to integrate the data into the ViCTER program.

Applicants must demonstrate the translational and/or transdisciplinary nature of the research aims proposed within the Competing Revision application and describe how the creation of the consortium will lead to synergy among the individual research projects.

Include a summary paragraph describing what will be the new data expected from the ViCTER, what will be the IMPACT on the field, and what will be the impact that would not have occurred without the ViCTER.

Research Strategy

Organizational and Administrative Structure of ViCTER (1 page)

As part of the overall research strategy begin with a description in detail and by diagram the organizational structure of the program including an administrative and management plan that achieve an integrated, coordinated interdisciplinary research program.

In broad terms describe how the administrative core supports the goals and organization of the program.

Describe the role of the Director and the investigators responsible for the direction of the research projects. Indicate how the Center’s progress towards expected scientific and training outcomes will be monitored and adjusted as needed.

Describe the relationships between the proposed ViCTER and other existing research, academic, and administrative units of the applicant institution such as schools, centers, institutions, departments, and central administration.

Research Strategy: Research Projects of ViCTER (11 pages)

The Research Strategy should be divided among the three projects and contain significance/innovation and approach with the focus on the approach and methods.

Each project (the project of the PI unique to the ViCTER which will expand the focus of the original R01 and the projects of each of the partner researchers) should clearly state its overall objective and explain its relevance to the central theme of the ViCTER program. In addition, an explanation should be included describing how the project relates to both complements and enhances the other research projects of the program.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

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/priority score to reflect their assessment of the likelihood for the project to produce synergy and exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

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

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Is the environmental health focus of the proposed Virtual Consortium an area where environmental factors are known or expected to influence the development or progression of disease? Is the translational and/or transdisciplinary focus proposed likely to stimulate synergy among the collaborators and accelerate the exchange of knowledge and resources among collaborators to improve human health? Will the creation of the Virtual Consortium make a greater contribution to the central environmental health problem of focus than if each of the individual collaborators conducted their projects alone?

Investigator(s)

Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or 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? Does each of the collaborators involved in the proposed ViCTER contribute unique expertise, resources, methods and/or technologies to the Virtual Consortium?

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 proposed Virtual Consortium represent a new, unique opportunity to foster translational and/or transdisciplinary research that has not been possible previously?

Approach

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

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed? Will the creation of the Virtual Consortium likely foster collaboration, integration and translation? Will the specific objectives of each project benefit significantly from, or depend upon collaborative interactions with the other projects in ViCTER (i.e. objectives that can be uniquely accomplished, specific contributions to the accomplishments of objectives in other projects, objectives that can be accomplished with greater effectiveness and/or economy of effort

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?

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

The ViCTER will be reviewed as a whole for its translational or transdisciplinary nature as well as the degree of synergy (interaction and collaborative research opportunities) that will be stimulated by the consortium. In gauging the overall Application Assessment the following terms are described:

Synergy. Do the new aims contribute to the state of the science beyond that of the individual projects? Will the outcomes of the new aims move the field in a new direction? In other words, will the subprojects contribute in such a way that the whole is greater than the sum of its parts? Does the ViCTER stimulate new collaborations?

Translational and/or Transdisciplinary Nature. Do the aims cross multiple disciplines or move basic science from the laboratory to the human populations or from population-based science into the laboratory?

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 Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable.

Renewals

Not Applicable.

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

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

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

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

Not Applicable.

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.

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

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/priority score.
• Will receive a written critique.

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 Institute of Environmental Health Sciences Advisory 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.

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 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 the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants 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

Not Applicable.

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

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.

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: [email protected]

Annette Kirshner, PhD
Cellular, Organs and Systems Pathobiology Branch
Division of Extramural Research and Training
Nation Institute of Environmental Health Sciences
P.O. Box 12233, K3-15
111 T.W. Alexander Drive
Research Triangle Park, NC 27709
Telephone: (919) 541 -0488
Fax: (919) 541-0462
Email: [email protected]

Jerrold J. Heindel, Ph.D.
Cellular, Organs and Systems Pathobiology Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, K3-15
111 T.W. Alexander Drive
Research Triangle Park, NC 27709
Telephone: 919-541-0781
Fax: 919-541-5064
Email: [email protected]

Janice Allen, Ph.D.
Scientific Review Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, K3-03
111 T.W. Alexander Drive
Keystone Building, Room 3080
Research Triangle Park, NC 27709
Phone: (919) 541-7556
Fax: (301)-451-5715
Email: [email protected]

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date

Wanda Boggs
Grants Management Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, K3-11
111 T.W. Alexander Drive
Research Triangle Park, NC 27709
Telephone: (919) 316-4638
Fax: (919) 541-2860
Email: [email protected]

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 Parts 74 and 92.