Department of Health and Human Services


Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Environmental Health Sciences (NIEHS)

Funding Opportunity Title

NIH Revision Awards for Creating Virtual Consortium for Translational/Transdisciplinary Environmental Research (ViCTER)(R01)

Activity Code

R01 - Research Project

Announcement Type

Reissue of PAR-11-046

Related Notices
  • June 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same.
Funding Opportunity Announcement (FOA) Number

PAR-14-050

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.1132

Funding Opportunity 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, model organisms and animal models, human populations or clinically-based research to provide data useful for the prevention of or the intervention in human disease.  

The goal of the Virtual 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 suspected to influence the development or progression of disease.  Each virtual consortium will consist of an NIEHS-funded researcher, who will serve as the PD/PI and overall coordinator of the consortium, and two new collaborators.  The 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 funded project with the goal of making the research more transdisciplinary and/or translational.   

Key Dates
Posted Date

December 20, 2013

Open Date (Earliest Submission Date)

February 4, 2014

Letter of Intent Due Date(s)

February 4, 2014, February 4, 2015, February 4, 2016

Application Due Date(s)

March 4 2014, March 4, 2015, March 4, 2016, by 5:00 PM local time of applicant organization.

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

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

May/June 2014, May/June 2015, May/June 2016

Advisory Council Review

October 2014, October 2015, October 2016

Earliest Start Date

November 1, 2014, November 1, 2015, November 1, 2016

Expiration Date

March 5, 2016

Due Dates for E.O. 12372

Not Applicable

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). 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.


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Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement


Section I. Funding Opportunity Description


Purpose

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 many types of approaches and methods such as in vitro cell culture systems, in vivo animal exposures, and population-based studies.

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 better characterize exposure and disease relationships including early biological perturbations, genetic and epigenetic variations, vulnerable populations, and complex mixtures. This integration includes an investment in approaches to effectively translate and disseminate complex research findings to the public to improve lives. 

However, these multi-factorial (disciplinary) efforts usually occur in select or limited laboratories and institutions due to lack of availability of resources, expertise or access to technology. Many investigators could greatly benefit from a more coordinated and integrated approach to facilitate translational/transdisciplinary research among 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 and Disease Prevention Research, Breast Cancer and the Environment Research Program and Centers for Neurodegeneration Science have moved in this direction by requiring both basic and human-based translational research. Some have required community outreach and education cores as well. However, these programs are large structured multicomponent grants that require strong preliminary evidence in areas of research with solid evidence of exposure/disease relationships. This Funding Opportunity Announcement (FOA) with set-aside funds and a special review offers such an opportunity by encouraging submission of 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 the bidirectional flow of information across the spectrum of in vitro, model organisms, animal models, human population or clinically-based research to provide data useful for the prevention of, or the intervention in human disease.  

Transdisciplinary research is defined as research that involves scientists 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.

This Initiative will allow investigators to expand the scope of a current NIEHS-funded R01 by developing new research teams creating 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. ViCTER projects are expected to foster a better understanding of the mechanism of disease/dysfunction in those areas where environmental factors are known or are suspected to influence the development or progression of the disease. These Revisions can be the start of a whole new direction for the parent R01.

Research Objectives

The objective of this program is to develop Virtual Consortia that will foster transdisciplinary collaboration and/or promote translational research 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 suspected to influence the development or progression of disease.  This Virtual Consortium Program is expected to initiate research in 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 augment existing research teams with additional expertise and use of 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 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 aims.  It is anticipated that the new aims proposed to expand the project will be exploratory in nature, may not yet be supported by preliminary data  and be high risk/high payoff. These newly added aims should also contribute to data and feasibility for future applications. Preliminary data are not required but may be submitted.

One of the critical components of the ViCTER Program is their virtual aspect. This allows researchers at remote locations to form a consortium to integrate their research through the development of a virtual center that “houses” the ViCTER and includes a consortium director (also referred to as the PD/PI of the consortium) who is responsible for scheduling regular (at least monthly) conference calls and encouraging annual update meetings.

The intent of this program is to stimulate a variety of possible results and outcomes including but not limited to the following:

NIEHS particularly encourages applicants to propose new aims that are high risk/high reward which, if successful, are likely to contribute significantly to the ViCTER program’s environmental health science field and be the motivator of future collaborative research.

The ViCTER supplemental aims are intended to be exploratory or high risk/high reward in nature and need not be supported by supplemental data, although supplemental data may be submitted.   The additional aims should be, well-defined and focused such that they can realistically be completed in two or three years.

Each ViCTER program will consist of at least three participants (the PD/PI plus two new collaborators).  A new collaborator is defined as someone who has not published with the PD/PI within the last five years (excluding reviews, white papers etc.).  In addition only one of the collaborators can be at the same Institution as the PD/PI.

The PD/PI 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 PD/PI will partner with two new collaborators (no prior or current research funding on their part is needed) to develop, write and implement an expanded research focus (at least one new aim per collaborator) that are thematically related and will expand the science, develop new ideas, and foster collaboration, integration and translation among the ViCTER virtual consortium team.  The overall research focus developed by the team 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). 

The PD/PI must be a current NIEHS-supported R01 awardee with a minimum of 2 years funding remaining on the parent grant of the proposed ViCTER at the time of award of the revision.

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

PDs/PIs are encouraged to consult with the Program Officer of their current grant with any questions about the eligibility of their R01 or their collaborators or any other issue relevant to the ViCTER application. 

Section II. Award Information
Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

Revision
Resubmissions to Revisions

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

Funds Available and Anticipated Number of Awards

NIEHS intends to fund an estimate of 4-5 awards, corresponding to a total of $2,000,000 for each fiscal year, 2015, 2016, and 2017.

Award Budget

Application budgets are limited to $250,000 direct cost but need to reflect the actual needs of the proposed project.

Award Project Period

Applicants must request support for 2 or3 years (no partial years), not to exceed the remaining number of years on the parent grant at the time of the next years renewal. The parent grant must be active during the entire project period proposed in the Revision application.

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.

Section III. Eligibility Information


1. Eligible Applicants


Eligible Organizations

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

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)

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

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

Applications must be submitted by the same PD/PI (or Contact PD/PI for multi-PD/PI grants) as listed on the current award. Eligibility is limited to PD(s)/PI(s) of active NIEHS-supported R01 awards with a minimum of 2 years remaining on the grant at the start date of the revision application.

Please note that the minimum is 3 years of non-competing funding remaining if requesting a project period of 3 years. If there are 3 years remaining, then an unsuccessful ViCTER application may be amended and resubmitted but for two years only.  Two year applications cannot be amended and resubmitted.

2. Cost Sharing

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

3. Additional Information on Eligibility


Number of Applications

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

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

Section IV. Application and Submission Information


1. Requesting an Application Package

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.

2. Content and Form of Application Submission

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.

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

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

The letter of intent should be emailed to:

Dr. Patricia Greenwel
Telephone: 301-435-1169
Email: greenwep@csr.nih.gov

Page Limitations

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

Required and Optional Components

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

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

Since the goal is to develop virtual consortia, only two of the consortium members (either the PD/PI and one collaborator, or two collaborators and not the PD/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 PD/PI or each other within the last 5 years.

R&R or Modular Budget

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

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.

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 PD/PI 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 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.

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Specific Aims:

Research Strategy: The Research Strategy should include the following elements:

Organizational and Administrative Structure of ViCTER

Research Aims of ViCTER

The Research Strategy should be divided among the  proposed new aims and contain significance/innovation and approach with the focus on the approach and methods.  It should note the high risk and preliminary nature of the proposed new aims as well as their defined nature.

The new research aims should have a clearly stated overall objective and explanation of their relevance to the central theme of the ViCTER program.  In addition, a description how the aims relate to and enhance the research focus of the ViCTER program should be included. 

State and justify the complex biological problem to be solved. Describe in adequate detail and explain the scientific synergy to this program and explain why the collaborative projects are critical to its solution. Describe the range of scientific expertise to be brought to bear on the problem. Make clear the significance and extension of the parent grant, and explain the value-added benefit of pursuing the problem with a collaborator within the parent grant rather than individual grants.

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). 

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

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide.

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

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

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide. 

Foreign Institutions

Foreign (non-U.S.) institutions are not eligible for this award, except as collaborators.

3. Submission Dates and Times

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). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

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

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

Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

Section V. Application Review Information


1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

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?

Overall Impact

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

Scored Review Criteria

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

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

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?  

Synergy   

Are there strong synergy and integration among the combined efforts of the various investigators within the overall program? Will the specific objectives of the overall research focus benefit significantly from, or depend upon collaborative interactions? Will the outcome move the field in a new direction or stimulate new collaborations? How will data from one aim feed into the other aims?

Additional Review Criteria

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

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 Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children 

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

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

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

Not Applicable

Revisions

For Revisions, the committee will consider the appropriateness of the proposed 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.

Additional Review Considerations

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

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

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.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s),convened by the Center for Scientific Review 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:

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:

3. Anticipated Announcement and Award Dates

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

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information


1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.      

Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

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

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. 

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-435-0714
TTY: 301-451-5936
Email: GrantsInfo@nih.gov

Scientific/Research Contact(s)

Annette Kirshner, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-0488
Email: kirshner@niehs.nih.gov

Peer Review Contact(s)

Patricia Greenwel, Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-435-1169
Email: greenwep@csr.nih.gov

Financial/Grants Management Contact(s)

Barbara Gittleman
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-0585
Email: gittleman@niehs.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.


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