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

Superfund Hazardous Substance Research and Training Program (P42)

Activity Code

P42 Hazardous Substances Basic Research Grants Program

Announcement Type

Reissue of RFA-ES-13-001

Related Notices

  • June 12, 2014 - This RFA has been reissued as RFA-ES-14-007.
  • May 16, 2014 - See Notice NOT-ES-14-008. Notice to Terminate effective immediately.

Funding Opportunity Announcement (FOA) Number

RFA-ES-14-001

Companion Funding Opportunity

None

Number of Applications

Only one application per institution is allowed, as defined in Section III. 3. Additional Information on Eligibility.

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

93.143   

Funding Opportunity Purpose

The National Institute of Environmental Health Sciences (NIEHS) is announcing the continuation of the Superfund Hazardous Substance Research and Training Program, referred to as Superfund Research Program (SRP) Centers. SRP Center grants will support problem-based, solution-oriented research Centers that consist of multiple, integrated projects representing both the biomedical and environmental science and engineering disciplines; as well as cores tasked with administrative, community engagement, research translation, training, and research support functions.  The scope of the SRP Centers is taken directly from the Superfund Amendments and Reauthorization Act of 1986, and includes: (1) advanced techniques for the detection, assessment, and evaluation of the effect on human health of hazardous substances; (2) methods to assess the risks to human health presented by hazardous substances; (3) methods and technologies to detect hazardous substances in the environment; and (4) basic biological, chemical, and physical methods to reduce the amount and toxicity of hazardous substances.     

Key Dates
Posted Date

November 18, 2013

Open Date (Earliest Submission Date)

March 10, 2014

Letter of Intent Due Date(s)

March 10, 2014

Application Due Date(s)

April 10, 2014, 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

October 2014

Advisory Council Review

January 2015

Earliest Start Date

April 2015

Expiration Date

April 11, 2014

Due Dates for E.O. 12372

Not Applicable

** ELECTRONIC APPLICATION SUBMISSION REQUIRED**

NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

Required Application Instructions

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

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

Research Objectives

The National Institute of Environmental Health Sciences (NIEHS) invites qualified investigators from domestic institutions of higher education to submit an application for a Superfund Research Program (SRP) Center grant.  SRP legislation, under the Superfund Amendments and Reauthorization Act (SARA) of 1986, allows NIEHS the flexibility to create university-based Centers to conduct scientific research to address the wide array of scientific uncertainties facing the national Superfund program.  The complex problems related to sites impacted by hazardous substances (e.g., Superfund and related sites) require the expertise of multiple biomedical and environmental science and engineering disciplines.  Applicants responding to this Funding Opportunity Announcement (FOA) are expected to design a research Center that integrates environmental health science with environmental science and engineering (e.g., geochemical, ecological sciences).  The goal of the NIEHS SRP Center is to improve public health by supporting integrative, multidisciplinary research incorporating the following:

1) advanced techniques for the detection, assessment, and evaluation of the effect of hazardous substances on human health;

2) methods to assess the risks to human health presented by hazardous substances;

3) methods and technologies to detect hazardous substances in the environment; and

4) basic biological, chemical, and physical methods to reduce the amount and toxicity of hazardous substances. 

To accomplish these mandates, Centers are expected to assemble interdisciplinary research and training teams with expertise in biomedical science, environmental science and engineering, research translation, and community engagement.

Applicants are encouraged to refer to the SRP’s Strategic Plan (http://www.niehs.nih.gov/research/supported/dert/cris/programs/srp/about/register/index.cfm) which describes and defines the objectives and goals of the SRP in order to address its mandates.  The three primary objectives of the SRP are to (1) address issues of high relevance, (2) maximize the impact of SRP investments, and (3) foster innovation.  In addition, the SRP Mandates are provided on the following website: http://www.niehs.nih.gov/research/supported/dert/cris/programs/srp/about/program/index.cfm.

Scope of the SRP Center Grant

The scope of the SRP Center is defined by the SRP Mandates.  Research and supporting activities under this FOA may utilize a variety of approaches to achieve SRP mandates, listed here: 

1) Advanced techniques for the detection, assessment, and evaluation of the effect of hazardous substances on human health. 

SRP seeks to support mechanistic and/or mode of action research that includes laboratory- and population-based studies for unraveling critical biological pathways that contribute to disease when perturbed by environmental contaminants.  Highly innovative approaches such as high-throughput screening techniques, systems biology, “omics” approaches, tissue engineering, and in silico modeling are desired.  Also, discovery and validation of biomarkers useful for exposure assessment, indicators of biological response, and disease susceptibility are important research activities with translational opportunities for improved risk assessment.  Priority will be placed on research with a clear connection to understanding health effects relevant to populations living near or affected by sites impacted by hazardous substances.  In addition, applicants are encouraged to pursue toxicological endpoints for chemicals lacking toxicological data that are also found at Superfund (and related) sites.

2) Methods to assess the risks to human health presented by hazardous substances.

Historically, risk assessments have been focused on developing models for either human health or ecological health; however, within the interdisciplinary framework of the SRP, integrated human and ecologic models may be developed to assist in making cost-effective and protective decisions.  As a component of risk, understanding the complex phenomena that impact exposure is an important research focus for the SRP.  Exposure science research of interest includes: fate, transport, and transformation of contaminants in the environment; contaminant bioavailability in the environment and in biological systems; identifying biomarkers of exposure; and quantifying body burden.  SRP also recognizes the need for developing methods to integrate exposure over time and to characterize the attributable risk from multiple exposures experienced over one’s lifetime.  Cumulative risk models should be used to synthesize findings from health effects research, susceptible life stages, and mode of action to support more complex exposure assessments in susceptible and diverse populations (e.g., medically and economically disadvantaged).  Studies that validate or confirm risk reduction due to prevention or intervention activities (e.g., remediation, nutritional intervention) are also within SRP scope.  Although SRP recognizes the important public health impact of research focusing on exposures to consumer product-related chemicals, non point-source air pollution, and non point-source drinking water, a higher priority will be placed on research with a clear connection to understanding exposures relevant to populations living near or affected by sites impacted by hazardous substances.

3) Methods and technologies to detect hazardous substances in the environment.

The SRP seeks to support the development and application of new and advanced technologies for detection and monitoring of hazardous substances.  Site characterization can be an expensive and invasive process.  The SRP seeks development of novel methods and devices that offer precise and low-cost measuring capabilities at hazardous waste sites.  This includes bioassays or ecological indicators that assess toxicity to biological systems at sites complicated by multiple contaminant streams or complex environmental media.  In addition, innovative tools that allow for real-time, minimally invasive, on-site monitoring are encouraged, including:  advanced sensors and probes, biosensors, new imaging modalities (e.g., geophysical imaging), self-contained miniaturized toxicity-screening kits, miniaturized analytical probes, and data analysis tools.  The SRP also seeks in situ devices that are capable of multi-analyte readings and/or determination of the degree of bioavailability of a contaminant.  Sensor research should apply to the complex media encountered at hazardous waste sites (soil, sediments, and groundwater).  Tool designs should take into account device reuse, waste generation, and utilization of non-toxic components (particularly for in situ devices).

4) Basic biological, chemical, and physical methods to reduce the amount and toxicity of hazardous substances.

The SRP supports the application of relevant research as a prevention strategy to improve human health by mitigating exposure and reducing toxicity of environmental contaminants.  SRP seeks research that is focused on the scientific principles and underlying processes that drive different remediation technologies as methods to clean up persistent toxicants in various media such as groundwater, sediments, fractured bedrock, and soils.  SRP encourages the continuum of research to focus on the translation of these basic principles into feasible, efficient, and cost-effective chemical, physical, and/or biological technologies that reduce the level of contaminants present in the environment.  Combined remediation approaches are encouraged as a means to maximize the complete degradation of hazardous substances at complex sites.  SRP also encourages development of greener and more sustainable remediation techniques that improve energy efficiency and reduce waste generation including innovative in situ remediation approaches.  The multidisciplinary framework of SRP facilitates collaboration between health effects, ecological and remediation scientists to assess and mitigate unintended toxicological implications of the remediation technology as well as assess the efficacy of remediation activities for reducing exposures risk and disease incidence.

Examples of Research Topics.  As specified in the SRP Strategic Plan, the SRP seeks to improve relevance through encouraging applicants to design problem-based, solution-oriented research to address the needs of its primary stakeholders (e.g., Superfund-related agencies, as well as the individuals and communities living near sites impacted by hazardous substances).  Hence, applicants are encouraged to engage stakeholders as they develop research projects in order to identify critical gaps in knowledge for which basic research is needed.  Furthermore, applicants are encouraged to develop community engagement research projects to address any one of the above mandates.  For a listing of research areas of interest to the SRP and its stakeholders, please refer to the “Suggested Research and Activities” document on the following website (http://www.niehs.nih.gov/research/supported/srp/funding/rfa.cfm).  This webpage also contains links to specific research needs identified by SRP’s sister Superfund agencies (EPA and ATSDR). 

Applicants are encouraged to propose research that fills gaps or needs not currently addressed within the SRP. A list of current grantees can be found at the following website: http://tools.niehs.nih.gov/srp/programs/index.cfm.

Hazardous Substances.  Although not a site-specific program, SRP Centers present a unique opportunity to address research needs of existing Superfund sites; hence, research on chemical contaminants (e.g., halogenated organics or pesticides) and minerals (e.g., metals, elongated mineral particles, or mine tailings) that are the drivers of risk at hazardous waste sites are highly relevant to SRP.  These include:

The applicant should refer to the “Suggested Research and Activities” document on the following website (http://www.niehs.nih.gov/research/supported/srp/funding/rfa.cfm) for a list of hazardous substances, including emerging contaminants, that have been suggested for study by SRP's sister agencies (i.e., EPA and ATSDR). 

Applicants should provide a clear description of how the hazardous substance(s) being studied and subsequent results are relevant to Superfund; lead to better decision making for risk assessors and remediation managers at Superfund sites; and/or address uncertainties involved in understanding the prevalence of disease/dysfunction and/or the effects on molecular, cellular, and pathophysiologic parameters that lead to disease/dysfunction associated with these hazardous substances.  Applicants are encouraged to consult with SRP program staff for specific questions about the relevancy of a hazardous substance for this FOA as the presence of a compound on one of the lists mentioned above does not automatically make it relevant to the SRP.

Activities on Hazardous Waste Sites 

Whether through project research or core activity, Centers are strongly encouraged to seek opportunities for interactions at Superfund and other managed hazardous waste sites.  If on-site activities will be conducted, researchers must coordinate with appropriate Federal or State site officials and must observe best safety practices.  When applicable, applicants must:

In addition, engagement of site officials in the early stages of project development and throughout the process is recommended, as this greatly increases the positive impact of SRP research and its utility to stakeholders. Contact information for SRP stakeholders can be found on the “Suggested Research and Activities” document on the following website: (http://www.niehs.nih.gov/research/supported/srp/funding/rfa.cfm).

NOTE: SRP is not a site-specific program. Applicants are not required to work on Superfund or hazardous waste sites. 

Annual Meetings

It is the intent of the NIEHS to hold annual grantee meetings. The location of the meeting site will rotate among the different grantees and Research Triangle Park, NC. See Section IV. Application and Submission Information.

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

New
Renewal
Resubmission

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 up to four awards, corresponding to a total of $8.5 million, for fiscal year 2015. Future year amounts will depend on annual appropriations.

Award Budget

A new application may request a budget for direct costs of up to $1.6 million dollars for the first year. Renewal applications may request a budget for direct costs of up to $2 million dollars for the first year. Third party F&A is not included in the direct cost limitation.

For all applications, budgets submitted in subsequent years may not exceed an escalation of two percent on recurring direct costs.

Award Project Period

New applications may propose an award period of up to 4 years. Renewal applications may propose an award period of up to 5 years. 

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:

Per NIEHS legislative authority, ONLY Higher Education Institutions may apply for award of this P42 FOA. Section 311(a)(3) of SARA limits recipients of awards to "accredited institutions of higher education," which are defined in the Higher Education Act, 20 USC (annotated) 3381. However, grantees are permitted under the law, and encouraged by NIEHS, to subcontract as appropriate with organizations, domestic or foreign, public or private (such as universities, colleges, hospitals, laboratories, faith-based organizations, units of State and local governments, and eligible agencies of the Federal Government) as necessary to conduct portions of the research. Examples of other organizations may include generators of hazardous wastes; persons involved in the detection, assessment, evaluation, and treatment of hazardous substances; owners and operators of facilities at which hazardous substances are located; State and local governments and community organizations.

Foreign Institutions

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

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

Required Registrations

Applicant Organizations

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

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.

For the purposes of this FOA, the Program Director/Principal Investigator (PD/PI) will be referred to as the "Center Director."  All project and core leaders will be referred to as "Project Leader" or "Core Leader."    

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

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

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

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 and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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

Letter of Intent

The information contained in a Letter of Intent allows IC staff to estimate the potential review workload and plan the review. However, it is not required, is not binding, and does not enter into the review of a subsequent application.

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

Sally Eckert Tilotta, PhD
Scientific Review Officer
Scientific Review Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences (NIEHS)
P.O. Box 12233; Mail drop K3-03
Research Triangle Park, NC 27709
Telephone: 919-541-1446
Fax: 301-451-5715
Email: sally.tilotta@nih.gov

For Courier delivery:
530 Davis Drive, Room 3076
Morrisville, NC 27560

Page Limitations

Component Types Available in ASSIST

Research Strategy/Program Plan Page Limits

Overall

12

Core (Use for Administrative, Research Translation, Community Engagement, Training, and Research Support Cores.  (Please enter in ASSIST using this order.)

12

Project (Use for Biomedical Projects and Environmental Science and Engineering Projects.  Note: Projects will be reviewed in the order in which they were entered into ASSIST)

12


Additional page limits described in the SF424 Application Guide and the Table of Page Limits must be followed, with the following additional requirements:

Instructions for the Submission of Multi-Component Applications

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

The application should consist of the following components:

Note: Applications must successfully meet these minimum requirements without exceeding a total of 12 components.  That is, the total number of components including 4 required projects, four required cores (Administrative Core, Research Translation Core, Community Engagement Core, and Training Core), and optional Research Support Core(s), cannot exceed 12).

Overall Component

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

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

SF424 (R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement  (Overall)

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

Research & Related Other Project Information (Overall)

Follow standard instructions.

Project Summary/Abstract. For the Overall Component, applicants must include a Project Summary/Abstract that briefly describes the problem(s) being addressed by the Overall Center, how the Center solves target problem(s) related to health effects, risk, detection and/or remediation of hazardous substances.  As opposed to a generic description of the Center components, the Project Summary should provide an overall indication of what the Center proposes.  For example, the summary should describe the hazardous substances, study sites, research approaches, model organisms/biological systems, disease pathways, etc.  In addition, the Center should highlight aspects of the application that are particularly innovative or paradigm-shifting.  The primary activities of the cores should be integrated into the summary.  The benefits of the Center (in terms of improving public health, risk assessment, and risk management) should also be included. Ideally, the project summary provides a depth of understanding of the science and activities of the Center written in plain language for a diverse set of reviewers.

Project Narrative. Similarly, it should be clear in the "Project Narrative" (i.e. the "public health relevance" statement) the relevance of the Center’s research to public health and to SRP stakeholders. SRP’s primary stakeholders are its sister Superfund programs at the U.S. Environmental Protection Agency (EPA) and Agency for Toxic Substances and Disease Registry (ATSDR).  Additional stakeholders include other Federal agencies, State, local, and Tribal entities responsible for sites impacted by hazardous substances, as well as the individuals and communities living near these sites.

Other Attachments: The following "Other Attachments" should be included with the overall component in order to aid in the review of applications.  The filename provided for each attachment will be the name used for the bookmark in the application image.

Project/Performance Site Location(s) (Overall)

Enter primary site only.

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

Research & Related Senior/Key Person Profile (Overall)

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

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

Budget (Overall)

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

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

PHS 398 Research Plan   (Overall)

Introduction to Application: For Resubmission applications, an Introduction to Application is required in the Overall component

Specific Aims: Applicants will provide Specific Aims for the Overall Center describing the objectives and goals of the Center, as they relate to the SRP Mandates. It should be clear how the components of the Center interact to solve the target problem(s), and the role of each project and core in contributing to resolving the problem(s) stated in the application.  This section should provide greater scientific detail and approaches than the Project Summary/Abstract.  In addition, each specific aim should be supported by a brief description of how that aim will be accomplished through interactions of projects and cores.     

Research Strategy: Applicants must include an overview of the Center.  In this section, applicants should clearly describe the problem(s) being addressed by the Overall Center, how the components of the Center interact to solve the target problem(s), and the role of each project and core in contributing to resolving the problem(s) related to health effects, risk, detection and/or remediation of hazardous substances.  This section should also include background information and a description of how the Center’s research fits into the SRP mandates; and how the Overall Center is relevant to SRP’s primary stakeholders (e.g., U.S. EPA, Agency for Toxic Substances and Disease Registry (ATSDR), other Federal agencies, State, local, and Tribal entities responsible for sites impacted by hazardous substances, and individuals and communities living near these sites).  Applicants should provide a clear description of how the hazardous substance(s) being studied and subsequent results are relevant to Superfund; lead to better decision making for risk assessors and remediation managers at Superfund sites; and/or address uncertainties involved in understanding the prevalence of disease/dysfunction and/or the effects on molecular, cellular, and pathophysiologic parameters that lead to disease/dysfunction associated with these hazardous substances.  A description of the innovative aspects of the Center should be included.  This section should also include a description of the multidisciplinary and interdisciplinary nature of the Center, the interactions between the projects and cores, how each project and core contributes to the Center’s theme, and how the Center will achieve the integration and interaction among biomedical and environmental science and engineering research.  Applicants should include a brief description of plans for the Administrative Core to facilitate the overall goals of the Center and maintain organization of the Center. (More detailed information on the management of these items should be included in the Administrative Core Research Strategy section.) The applicant should delineate a timeline for the synthesis of key data and findings from the projects and cores as it pertains to approaching a resolution to the stated problem(s).  The following subsections are recommended: Overall Goals and Objectives; Background Information; Relevance to SRP Primary Stakeholders; Significance of the Research; Innovation; Integration of Multiple Disciplines; Center Management; Organizational Structure; and Timeline.

For Renewal Applications. Renewal applications must include, in the Research Strategy, a general progress report that describes achievements under the grant since the last competitive review. The Center Director (i.e., Program Director/Principal Investigator) should carefully prepare this section, and it should not be a copy of the material included for the individual projects. (The individual research projects will also provide a “Progress Report” under the “Approach” section of the Research Strategy.)  This is the section where the benefits of the Center can be expressed/demonstrated. Items to be included are:

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.   

Research Project Components

The SRP requires a minimum of two biomedical and two environmental science and engineering research projects.  Applicants may include, as part of their Center, Community Engagement Research Project(s), which are hypothesis-driven research projects addressing science-based questions based on needs identified by the community (defined as communities impacted by sites contaminated with hazardous substances). Community Engagement Research project(s), if proposed, count towards the minimum two biomedical or two environmental science and engineering projects, depending on the theme of the research project.

Collectively, the Center's research projects should emphasize a balance of basic and applied research that contributes to the problem-based, solution-oriented goal of the Center.  The Center’s central problem should be addressed by the contributions of these projects and should, therefore, include the biomedical and environmental science and engineering expertise necessary to address the central problem. Each project should contribute to the overall Center objective, providing a clear step towards identifying solutions to these problems.  Projects should be hypothesis-driven or product-oriented research.

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

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

SF424 (R&R) Cover (Research Project)

Complete only the following fields:

PHS 398 Cover Page Supplement (Research Project)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Project)

Project Summary/Abstract. For each project, applicants must include a Project Summary/Abstract that briefly describes how the project will solve target problem(s) related to health effects, risk, detection and/or remediation of hazardous substances.  For example, the summary should describe the hazardous substances, study sites, research approaches, model organisms/biological systems, disease pathways, etc.  In addition, the project should highlight aspects of the application that are particularly innovative or paradigm-shifting. Ideally, the project summary provides a depth of understanding of the science and activities of the project written in plain language for a diverse set of reviewers.

Project Narrative:  Similarly, it should be clear in the "Project Narrative" (i.e. the "public health relevance" statement) the relevance of the project’s research to public health and to SRP stakeholders. SRP’s primary stakeholders are its sister Superfund programs at the U.S. Environmental Protection Agency (EPA) and Agency for Toxic Substances and Disease Registry (ATSDR). Additional stakeholders include other Federal agencies, State, local, and Tribal entities responsible for sites impacted by hazardous substances, as well as the individuals and communities living near these sites.

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

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question. Do not complete.

Project /Performance Site Location(s) (Research Project)

List all performance sites that apply to the specific component.

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

Research & Related Senior/Key Person Profile (Research Project)

Budget (Research Project)

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

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

PHS 398 Research Plan          (Research Project)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component

Specific Aims: Specific Aims should describe the objectives and goals of the project as it relates to the SRP Mandates. The specific aims section should also contain a brief statement about how the project integrates with the rest of the Center.

Research Strategy:  The biomedical research projects should address biomedical or human health-related implications of hazardous substances.  This includes but is not limited to: mechanistic-based toxicology studies, epidemiology, human risk assessment, genetic susceptibility, computational toxicology, or biomedical engineering. 

The environmental science and engineering research projects should address environmental science or engineering implications of hazardous substances.  These projects are integral to the protection of human health through predicting, detecting, and preventing exposures.  Environmental science and engineering research projects include, but would not be limited to: civil/environmental engineering, geology, ecology, microbiology, fate and transport studies, hydrogeology, remediation and detection sciences. 

The Research Strategy section should be sub-divided into three parts: Significance, Innovation, and Approach.

For Community Engagement Research Projects, the Research Strategy is expected to include a "Community Engagement Statement" which describes community-based participatory processes of planning, implementing, and communicating pertinent research results to the community.  The Community Engagement Statement should:

Each project should also include a "Relation to Overall Center" statement.  In this statement, clearly state the relevance of the project to the goals of the overall Center, how this project integrates with other projects and cores, and how the findings/activities of this project assist in solving the problem(s) that the Center is addressing. Interactions with the Research Translation Core should also be included.

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. For this FOA, a Resource Sharing Plan is expected for all Projects and should be included within each "Project" component in ASSIST. Projects are expected to include a "Resource Sharing Plan" which includes a Data Sharing Plan consisting of a Research Data Sharing Plan as well as an Investigator-Initiated Research Translation Plan.

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  (Research Project)

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 (Research Project)

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

Administrative Core

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

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

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

PHS 398 Cover Page Supplement (Administrative Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administrative Core)

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

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

Project Narrative:  Do not complete.

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

List all performance sites that apply to the specific component.

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

Research & Related Senior/Key Person Profile (Administrative Core)

The application must name the Center Director who will serve as the Program Director/Principal Investigator (PD/PI) of the Center and Core Leader of the Administrative Core. 

Budget (Administrative Core)

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

Funds for travel by appropriate staff (i.e., Center Director, Project/Core Leaders, Center Administrator, and four trainees) to attend the Superfund Research Program three-day annual meeting shall be included in the Administrative Core’s budget for each year.

The Center Director must commit a minimum of 1.8 person months to the administration of the Center. The Administrative Core annual budget must not to exceed $125,000 Direct Costs for both new and renewal applications. Note: the sum of Direct Costs for the Administrative, Research Translation, Community Engagement, and Training Cores cannot exceed 20% of the total Direct Costs of the Center per year ($320,000 Direct Costs for New Applicants; $400,000 Direct Costs for Renewal Applicants). 

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

PHS 398 Research Plan (Administrative Core)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component

Specific Aims:   Specific Aims should describe the objectives and goals of the Core.  The specific aims section should also contain a brief statement about how the Core integrates with the rest of the Center.   

Research Strategy: The application should describe how the Administrative Core and Center Director will provide leadership and guidance in ensuring the synthesis of findings and activities from research projects and cores towards solving the central problem/objective proposed by the Center.  To accomplish this, the applicant must create within the Administrative Core an infrastructure that promotes cross-discipline interactions among all of the projects and cores and ensures research translation.  I

The Administrative Core's Research Strategy should demonstrate how the core will achieve its administrative functions, as described below.  The applicant should include a description of the lines of communication among the Center project and core leaders, and a description of the mechanisms to be used to encourage and ensure the integration and interaction between the biomedical and environmental science and engineering projects within the Center.  The plan should also describe their strategy for planning and coordinating research and core activities; coordinating research activities and research translation activities; the integration of cross-disciplinary research; overseeing of fiscal and resource management; and providing quality management. This section should indicate who will be responsible for each of these activities and should describe the role(s) of advisory groups and consultants.

To aid the Center Director in achieving the goals set forth for his or her Center, the Administrative Core is required to establish an External Advisory Committee (EAC) to provide guidance to the Center Director in the following areas:

The composition of the committee will reflect the goals of the Center and will include appropriate scientific expertise and appropriate stakeholders, which will include, for example, representatives from the EPA, ATSDR, industry, and/or community organizations, as examples.  All applicants should list the anticipated/target areas of expertise for EAC members.  New applicants should not list names of anticipated EAC members, unless they provide input into the design of the application.  

The Administrative Core should also include a "Relation to Overall Center" statement.  In this statement, clearly state the relevance of the Core to the goals of the overall Center, how this Core will integrate with other projects and cores, and how the findings/activities of this Core will assist in solving the problem(s) that the Center is addressing.  Interactions with the Research Translation Core should also be included.

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  (Administrative Core)

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

PHS 398 Cumulative Inclusion Enrollment Report (Administrative Core)

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

Research Translation Core

The SRP requires a Research Translation Core (RTC) in each SRP Center grant application.  For the purpose of this FOA, the SRP defines Research Translation as “communicating and facilitating the use of research findings emanating from the Center in the manner most appropriate for their application and the advancement of research objectives.”  The SRP Strategic Plan highlights the importance of investigator-initiated research translation.  Hence, each RTC has a critical role in assisting project/core leaders in translating research outcomes to appropriate audiences, thereby encouraging the accurate and timely use of these research products.

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

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

SF424 (R&R) Cover (Research Translation Core)

Complete only the following fields:

PHS 398 Cover Page Supplement (Research Translation Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Translation Core)

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

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

Project Narrative:  Do not complete.

Project/Performance Site Location(s) (Research Translation Core)

List all performance sites that apply to the specific component.

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

Research & Related Senior/Key Person Profile (Research Translation Core)

The RTC leader/staff should have the appropriate scientific and policy background to effectively work within their Center to translate research and effectively work with science and public health experts.

Budget (Research Translation Core)

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

The Research Translation Core annual budget must not to exceed $125,000 Direct Costs for both new and renewal applications. Note: the sum of Direct Costs for the Administrative, Research Translation, Community Engagement, and Training Cores cannot exceed 20% of the total Direct Costs of the Center per year ($320,000 Direct Costs for New Applicants; $400,000 Direct Costs for Renewal Applicants). 

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

PHS 398 Research Plan (Research Translation Core)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

Specific Aims: Specific Aims should describe the plan for research translation which includes: 1) Communicating within SRP; 2) Partnerships with Government Agencies; 3) Technology Transfer; 4) Information Dissemination to Other End-users.  The specific aims section should also contain a brief statement about how the Core integrates with the rest of the Center.

Research Strategy: Within the Research Strategy, the application should describe how the RTC will achieve the following objectives in support of achieving effective research translation: 1) Communicating within SRP; 2) Partnerships with Government Agencies; 3) Technology Transfer; 4) Information Dissemination to Other End-users.  The Research Strategy section should provide a plan to achieve all four objectives.  These objectives are described below:

1)  Communicating within SRP:  NIEHS requires the RTC to communicate both within its institutional Center, as well as the greater SRP community (i.e. other SRP Centers, grantees, and SRP staff at NIEHS).  Therefore, there is an expectation for the RTC to serve several key communication roles such as:

a) Project-specific translation: RTC will work with project investigators to identify and coordinate research translation opportunities for each Center project and cores, as appropriate (see Project "Resource Sharing Plan" above);

b) Center-specific translation: pursuing research translation opportunities emanating from the goals of the overall Center (as opposed to an individual research project);

c) SRP communication: reporting research translation and other activities to SRP staff at NIEHS; and

d) Cross-Center communication: communicating with RTCs from other SRP Centers.

Applicants are expected to delineate a plan and timeline for coordinating activities at all four levels listed above. Of note, a direct line of communication between the Administrative Core and the RTC is extremely important, given the role of the Administrative Core to ensure an effective research translation strategy for the Center. Points of contact should be indicated in the Research Strategy section, particularly with regard to monthly SRP RTC/CE conference calls and submitting Center materials to the SRP Data Collection Form. (The SRP Data Collection Form allows grantees to inform SRP staff of Center Activities such as webinars/meetings, interactions with stakeholders, trainee/investigator awards, news articles and publications: http://tools.niehs.nih.gov/srp/resources/rtc.cfm.)

2) Partnerships with Government Agencies: Establishing ongoing communication with the Federal, State, local, and/or Tribal agencies charged with protecting human health and the environment is of high importance. These partnerships ensure that governmental offices have first-hand access to the valuable resources the Center can provide, and that the investigators have feedback on the real and immediate needs faced by their counterparts in the public sector.  EPA and ATSDR are directly involved in Superfund efforts (e.g., remediation, risk assessments, exposure studies); therefore, partnerships with these agencies are a high priority to SRP.  It is important that in the Research Strategy, each applicant has a plan delineating bi-directional interactions with the appropriate government agencies, identifying shared interests and outlining how to address these needs/interests. 

3) Technology Transfer: It is important that each Center identifies opportunities and delineates mechanisms for the transfer of biomedical and environmental science and engineering technologies generated by the grantee into the hands of an end-user. This may be accomplished through coordinating with formal technology transfer mechanisms (patents, Small Business Innovation Research/Small Business Technology Transfer Research grants, coordinating with institutional technology transfer offices), as well as informally through moving research from bench scale to demonstration, creating web-accessible data sharing systems to host information that may improve upon current risk assessments, or moving biomarker research towards epidemiological, clinical, or population based applications. As part of technology transfer, grantees are encouraged to provide informal technology support, to document the use of the research product, and to assess its value to public health or environmental management.

4) Information Dissemination to Other End-users: Another important RTC activity is to transfer the knowledge gained from Center activities (scientific discoveries, research findings) beyond the government or marketplace, allowing Center outcomes to make a broader impact. The intent is to bring together and provide a forum for investigators and stakeholders to enhance collaboration and utilization of SRP research. SRP therefore requires a plan to disseminate information from the Center to other important end-users such as formal/informal educational groups, hazardous waste practitioners, the lay public, and other academic researchers.   

A variety of appropriate RTC activities and resources, including stakeholder contact information, have been listed in the “Suggested Research and Activities” document on the following website (http://www.niehs.nih.gov/research/supported/srp/funding/rfa.cfm).  For all such activities, best communication practices must be utilized.  As a reference, please see the NIH website on plain language: http://grants.nih.gov/grants/plain_language.htm.  Use of web-broadcasting of these communication activities is particularly encouraged to accommodate stakeholders in remote locations or with limited travel options.

The Research Translation Core should also include a "Relation to Overall Center" statement.  In this statement, clearly state the relevance of the Core to the goals of the overall Center, how this Core will integrate with other projects and cores, and how the findings/activities of this Core will assist in solving the problem(s) that the Center is addressing.   

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, with the following modification:

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.   

Planned Enrollment Report  (Research Translation Core)

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

PHS 398 Cumulative Inclusion Enrollment Report (Research Translation Core)

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

Community Engagement Core

SRP requires each Center to establish a Community Engagement Core (CEC) to enhance the exchange of knowledge and to support the needs of the community with regard to the science emanating from the Center. 

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

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

SF424 (R&R) Cover (Community Engagement Core)

Complete only the following fields:

PHS 398 Cover Page Supplement (Community Engagement Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Community Engagement Core)

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

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

Project Narrative:  Do not complete.

Project /Performance Site Location(s) (Community Engagement Core)

List all performance sites that apply to the specific component.

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

Research & Related Senior/Key Person Profile (Community Engagement Core)

Budget (Community Engagement Core)

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

The Community Engagement Core annual budget must not to exceed $100,000 Direct Costs for both new and renewal applications. Note: the sum of Direct Costs for the Administrative, Research Translation, Community Engagement, and Training Cores cannot exceed 20% of the total Direct Costs of the Center per year ($320,000 Direct Costs for New Applicants; $400,000 Direct Costs for Renewal Applicants). 

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

PHS398 Research Plan (Community Engagement Core)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

Specific Aims: Specific Aims should describe the objectives and goals of the Core.  The specific aims section should also contain a brief statement about how the Core integrates with the rest of the Center.

Research Strategy: The SRP defines target communities as those impacted by sites contaminated with hazardous substances; therefore, CEC activities should involve partnerships with members of the affected community.  Partnerships may also include community-serving organizations such as: local government groups, Tribal councils, community service groups focused on educating the community about local issues, or non-governmental organizations working closely with a community.  There is particular interest in engagement of economically disadvantaged, environmental justice (EJ), and Tribal communities which are severely impacted by sites contaminated with hazardous substances. It is important to note that communities are often comprised of several distinct subpopulations. Community representation should reflect the various segments within an affected community and translation of research findings should be targeted to the specific needs of these distinct groups.  This might include identifying informational needs based on age, ethnicity, race, gender, or residency status (permanent vs. transient).

The CEC is to be designed to fit within the theme of the Center and to support the needs of the community. Appropriate objectives include capacity building, developing tools/resources, facilitating bi-directional exchange between Center scientists and the community.  A variety of appropriate CEC activities and resources have been listed in the “Suggested Research and Activities” document on the following website (http://www.niehs.nih.gov/research/supported/srp/funding/rfa.cfm).  As an outgrowth of CEC activities, interactions with the community should enhance the Center’s research agenda, providing a source of information valuable for the Center’s planning purposes or for the development of community engagement projects. 

In the Research Strategy, the CEC will include a timeline with milestones, a plan to evaluate outcomes, a logic model, and a process to guarantee effective bi-directional exchange of needs, recommendations, and results. Expectations between the community and academic partners should be made transparent, including deliverables, time commitment, as well as plans for future interactions beyond the life of the grant. Also within the Research Strategy, the CEC will include a Community Engagement Statement to describe the community-based participatory processes being utilized. This statement should:

The Community Engagement Core should also include a "Relation to Overall Center" statement.  In this statement, clearly state the relevance of the Core to the goals of the overall Center, how this Core will integrate with other projects and cores, and how the findings/activities of this Core will assist in solving the problem(s) that the Center is addressing.  Interactions with the Research Translation Core should also be included.

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  (Community Engagement Core)

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

PHS 398 Cumulative Inclusion Enrollment Report (Community Engagement Core)

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

Training Core

The SRP requires applicants to include a Training Core to support graduate and postdoctoral level cross-disciplinary training in fields related to environmental health and environmental science and engineering.  The SRP defines "trainees" within the core as graduate students and post-doctoral researchers as either supported directly by the Center or performing research/activities that are supported by the Center.

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

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

SF424 (R&R) Cover (Training Core)

Complete only the following fields:

PHS 398 Cover Page Supplement (Training Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Training Core)

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

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

Project Narrative:  Do not complete.

Other Attachments:

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

List all performance sites that apply to the specific component.

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

Research & Related Senior/Key Person Profile (Training Core)

Budget (Training Core)

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

Salaries and fringe benefits consistent with institutional policies may be requested. Funds may also be requested for tuition, where appropriate, and travel to one scientific meeting per year.  The training of pre- and post-doctoral students may be conducted outside the structured Training Core, and may occur within a project or another core.  In these instances, salary and other related training costs (e.g., equipment, supplies) should be part of the project or core budgets rather than the Training Core budget. However, it is recommended to indicate (in the Training Core budget justification) the number of trainees participating in the Training Core whose salary/costs are being covered in their respective research projects/cores. For budget purposes, trainees should be listed in the appropriate project/core budget pages, and should not be listed as key personnel.

The Training Core annual budget must not to exceed $100,000 Direct Costs for new applicants or $125,000 Direct Costs for renewal applicants.  Note: the sum of Direct Costs for the Administrative, Research Translation, Community Engagement, and Training Cores cannot exceed 20% of the total Direct Costs of the Center per year ($320,000 Direct Costs for New Applicants; $400,000 Direct Costs for Renewal Applicants). 

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

PHS 398 Research Plan (Training Core)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

Specific Aims: Specific Aims should describe the objectives and goals of the Core.  The specific aims section should also contain a brief statement about how the Core integrates with the rest of the Center.

Research Strategy: The Training Core should reflect the interdisciplinary nature of the overall research effort of the Center by enhancing cross-training of trainees in disciplines not traditionally linked with the university graduate structure.  For instance, trainees pursuing degrees in the environmental science and engineering areas should be encouraged to understand how their research fits into the context of environmental health sciences and vice versa for biomedical trainees.  Recommended Training Core activities have been listed in the “Suggested Research and Activities” document (see: http://www.niehs.nih.gov/research/supported/srp/funding/rfa.cfm). 

The Research Strategy for this core should include: 1) how the core will use interdisciplinary approaches to training; 2) how the core will provide trainees (i.e., graduate students and post-doctoral researchers) with opportunities to develop their current research/activities to enhance their own  professional career development and to receive training on best practices in Responsible Conduct of Research; 3) how the core will coordinate trainee participation in the Community Engagement and Research Translation Cores; and 4) how the core will report information about the Center’s trainees to the SRP.  The Research Strategy should also include a recruitment plan for all trainees, referencing the "Diversity Recruitment and Retention Plan," as appropriate. 

All trainees conducting research/activities supported by the Center (regardless if receiving direct support from the Training Core or other projects/cores) should be listed in the Training Core as well as their respective projects/cores (trainees listed in renewal applications should also be entered into NIEHS CareerTrac).  Individuals in the training positions must be considered employees of the institution and not trainees receiving stipends as in National Research Service Award programs. 

For new applications, the core should identify a plan for communication with the Research Translation Core and the Administrative Core to provide information about trainee publications, activities, awards, and accomplishments, to ensure that this information is being communicated to SRP staff and to the public.  For renewal applications, this information should be summarized in the application.

The Training Core description should include a timeline with milestones including frequency (e.g., annually) of updating trainee information in NIEHS CareerTrac. The Training Core should also indicate the point of contact for trainee information submission to the NIH CareerTrac database.

The Training Core should also include a "Relation to Overall Center" statement.  In this statement, clearly state the relevance of the core to the goals of the overall Center, how this core integrates with other projects and cores, and how the findings/activities of this core assist in solving the problem(s) that the Center is addressing. Interactions with the Research Translation Core should also be included.

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  (Training Core)

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

PHS 398 Cumulative Inclusion Enrollment Report (Training Core)

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

Research Support Cores

SRP Centers may choose to include Research Support Core(s) to provide essential, centralized services or resources that will result in an economy of effort and/or savings to the overall costs of a Center.  They can also serve as a useful tool in promoting interdisciplinary activities.  When proposed by a Center, a Research Support Core must support at least two or more research projects.  Typical core facilities include laboratory facilities, biostatistics and/or bioinformatics support, or analytical equipment and services. 

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

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

SF424 (R&R) Cover (Research Support Core)

Complete only the following fields:

PHS 398 Cover Page Supplement (Research Support Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information Component (Research Support Cores)

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

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

Project Narrative:  Do not complete.

Other Attachments:

Quality Assurance Statements. Quality Assurance Statements will be necessary ONLY for Research Support Cores that provide analytical, quantitative services to the applicant’s Center. The Quality Assurance Statement documents a Center's policy on implementing and assessing the effectiveness of its quality assurance and quality control operations. General guidance can be found at http://www.epa.gov/ncer/guidance/guidanceqmps0607.pdf. For more detailed guidance, see EPA Requirements for Quality Management Plans (EPA QA/R-2) on the EPA website at http://www.epa.gov/quality/qs-docs/r2-final.pdf.

The Quality Assurance Statement should include items such as:

Project /Performance Site Location(s) (Research Support Core)

List all performance sites that apply to the specific component.

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

Research & Related Senior/Key Person Profile (Research Support Core)

Budget (Research Support Core)

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

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

PHS398 Research Plan (Research Support Cores)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

Specific Aims: Specific Aims should describe the objectives and goals of the Core.  The specific aims section should also contain a brief statement about how the Core integrates with the rest of the Center.

Research Strategy: In the Research Strategy, the applicant must include the description of the core, the services to be rendered, the methodological approaches to be used, and a plan for prioritizing the use of the facility by Center members. This section must clearly present the facilities, techniques, and professional skills that the core will provide.  As justification for the core, briefly indicate the specific Research Projects that will use the resources of the core.  Be certain to reference relevant tables (e.g. "Table of Research Support Core Utilization," described above). A Research Support Core is principally designed as a service or resource component; it would be highly unusual to include research in a core (a possible exception would be methodology development). Describe the role of the core as a resource to the Center as a whole. Discuss ways in which these centralized services will produce an economy of effort and/or savings in overall costs compared to their inclusion as part of each project in the Center.

Progress Report for Renewal Applications: For renewals, summarize activities carried out during the preceding performance period. Include core utilization by the individual Research Projects. 

The Research Support Core should also include a "Relation to Overall Center" statement.  In this statement, clearly state the relevance of the core to the goals of the overall Center, how this core integrates with other projects and cores, and how the findings/activities of this core assist in solving the problem(s) that the Center is addressing. Interactions with the Research Translation Core should also be included.

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  (Research Support Core)

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

PHS 398 Cumulative Inclusion Enrollment Report (Research Support Core)

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

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

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

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.

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

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

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

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

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by the National Institute of Environmental Health Sciences, NIH. Applications lacking clear relevance to Superfund will be considered nonresponsive. Applications that are incomplete and/or nonresponsive will not be reviewed.

Funding Opportunity Web Seminar

On January 16, 2014 from 1:30 - 3:00 PM EST, a free informational webinar will be held to provide information about this FOA.  Information about how to register for this web seminar can be found on the following website (http://www.niehs.nih.gov/research/supported/dert/cris/programs/srp/funding/webinars/index.cfm). 

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.

For this particular announcement, each application will be evaluated both on the basis of the overall impact of the application as a whole and the overall impact of each of the individual components.  Cores and projects will receive individual priority scores.  Research projects will also receive criterion scores on significance, investigators, innovation, approach, and environment.  Finally, the overall application will receive an overall impact score reflecting the reviewers' assessment of the Center's Significance, Investigator(s), Innovation, Approach, Environment, and Integration as well as the likelihood the Center will be successful in accomplishing its goals.

Overall Impact - Overall

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

Review Criteria - Center

An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a Center that by its nature is not innovative may be essential to advance a field.

Significance

Does the SRP Center address an important problem or critical barrier to our knowledge of human health effects, risks, detection, and mitigation of hazardous substances in the environment?

If successful, would the SRP Center provide data, information, and knowledge to inform the risk assessment and remediation management processes for hazardous waste sites? If successful, would the SRP Center provide a rigorous scientific basis for effective decision-making? Will the Center further the knowledge of environmental health sciences to understand the physical, chemical and biological properties of hazardous substances in the environment?

If the Center were successful, would it lead to an incremental advance, or would it provide a substantial step forward?  

Investigator(s)

Do the experience and scientific leadership of the Center's Director (PD) allow him/her to effectively direct a large complex multidisciplinary Center; and coordinate the interactions of the research projects with effective utilization of Cores to achieve programmatic goals? Is there evidence the Center Director has brought together complementary and integrated expertise, among projects and core leaders, to accomplish the goals of the Center?  Are the leadership approach, governance and organizational structure appropriate for the Center? 

Innovation

Does the Overall SRP Center propose an innovative solution to critical barriers in the understanding of the physical, chemical, and biological properties of hazardous substances in the environment? Does the Center utilize novel theoretical concepts, approaches or methodologies, instrumentation, or interventions to solve complex problems associated with hazardous substances?  

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Center? Are potential problems, alternative strategies, and benchmarks for success presented? Would the expected achievements of the Center be possible through mechanisms other than this multi-project Center?    

Environment

Will the Center's scientific environment contribute to the probability of success? Is there evidence of institutional support for the Center, including evidence of interdepartmental cooperation in order to carry out the multi-disciplinary activities of the Center?    

Integration of the SRP Center

Does the Center propose to integrate projects and cores to target problem(s) within SRP's mandate areas?  Is there evidence that interaction between projects and cores is necessary or ideal to resolve the problem the Center proposes to address?  Is there evidence of integration and interaction of the biomedical related research with the environmental science- and engineering-based research as it contributes to the accomplishment of Center goals? Is there evidence of integration of the Administrative, Research Translation, Community Engagement and Training Cores with the Research Projects (and Research Support Cores, if applicable)? Is there evidence for the translation and delivery of the research findings to appropriate audiences?

Is there strong synergy among the combined efforts of the various investigators within the overall Center? Are the size and structure of the Center sufficient to afford effective interaction focused on a specific central theme, but diverse enough in scientific disciplines in order to achieve meaningful contributions to protecting human health and the environment?

Additional Review Criteria - Center

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children 

When the proposed Center involves 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 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

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

Is there evidence of progress and achievements specific to this Center since the previous competitive review?  Is there documentation through publications and conferences that demonstrates that collaboration between or among projects has occurred? Is there evidence of integration and synergy among the projects and cores within the Center? Is there evidence that the cores have met their objectives and been well utilized by the individual research projects? Is there adequate justification for adding new projects or cores or for deleting components previously supported?

Revisions

Not Applicable

Additional Review Considerations - Center

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

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

Overall Impact – Research Projects and Cores

In addition to the Overall Impact score for the Center, reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project/core 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 or core proposed).

Review Criteria Specific to Research Projects

Reviewers will provide an overall impact score to each project in consideration of the five Scored Review Criteria (Significance, Investigator(s), Innovation, Approach, and Environment) and its contribution to Overall SRP Center (see Additional Review Criteria for all Projects and Cores). A separate score will be given for each of the five scored review criteria as part of the determination of scientific merit. A project 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.   The “Contribution to Overall SRP Center” criterion is not scored separately, but is considered in the determination of the overall impact score of the project.

Significance (Research Projects)

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?

If the study is successful, would it lead to incremental advance, or would it provide a substantial step forward that would likely not be achieved through mechanisms other than this multi-project Center? If successful, will the project result in knowledge or resources that could be utilized to improve human health, risk assessment, or improve the quality of the environment? If successful, would the project provide data, information, and knowledge to inform the processes of risk assessment or remediation management for hazardous waste sites? Will the project provide rigorous scientific data that might be used for effective decision-making by stakeholders?

For Community Engagement Research Projects, are the objectives of the core of high interest/priority to the community? Will the project lead to a mutually-beneficial, bidirectional relationship between the academic institution and the community?

Investigator(s) (Research Projects)

Are the project investigators (i.e. lead investigator for the project), 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?

For Community Engagement Research Projects, does the investigator provide previous experience/evidence for conducting community engagement activities? Does the research environment enhance the likelihood of success?

Innovation (Research Projects)

Does the project 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 project propose an innovative solution to a critical barrier to progress in the understanding of the physical, chemical and biological properties of hazardous substances in the environment?

Approach (Research Projects)

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?

If the project involves research on hazardous waste sites or nearby communities, is there a plan proposed to involve the appropriate Federal, State, or Tribal agency?

For each project, does the “Investigator-Initiated Research Translation Plan" describe how research translation will be conducted?  Do the Project investigators have a plan to work in conjunction with the Research Translation Core to identify appropriate research translation opportunities? 

For Community Engagement Research Projects, is the community of interest clearly defined? Are the community's and academic partners' roles clearly described? Is there evidence of the community's acceptance as a partner in the core? Is the community an integral part of the activity? Is the approach appropriate according to community socioeconomic and cultural factors? Does the management plan adequately describe a process for maintaining transparent communications between the community and the academic partners throughout the entire process of the activity? Does the plan address methods of building and sustaining community partnerships and community participation?

Environment  (Research Projects)

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?

Review Criteria Specific to Administrative Core

The Administrative Core score will be based on review criteria below and its contribution to Overall SRP Center (see "Additional Review Criteria - Research Projects and Cores” below).

Objectives (Administrative Core)

Are the objectives of the Administrative Core appropriate to the Center? Are the approaches and methods proposed adequate to achieve objectives? Do the Administrative Core objectives reflect the interdisciplinary nature of the Center?

Management  (Administrative Core)

Is there evidence that the lines of authority and the administrative structure are designed for effective management of the Center? Is there a decision-making process for the management of funds and resources? Is there evidence of an ability to provide administrative support to the project and core leaders?

Coordination and Integration  (Administrative Core)

Is there evidence of an internal plan to promote integration and coordination? Does the Center’s internal plan promote coordination of interdisciplinary research and stimulate collaborations among constituent research projects and cores, particularly with regard to biomedical and environmental science and engineering project interactions? Are interactions between projects, cores, and external partners/communities evident?

External Advisory Committee  (Administrative Core)

Is there an appropriate plan to establish and use an external advisory committee? Do the members of the committee have the expertise required to evaluate all projects and cores and appropriately represent the applicant’s stakeholders including US EPA or ATSDR (as applicable to renewal applicants)? For new applications, are the appropriate expertise identified for the proposed External Advisory Committee?

Qualifications  (Administrative Core)

Does the senior leadership have appropriate experience and have they demonstrated effective and responsible leadership in the past? Is the percent effort requested adequate? Are the qualifications, duties and time commitments of administrative staff appropriate to contribute to the needs and conduct of the Center’s research activities?

Environment  (Administrative Core)

Is the institutional commitment adequate? Is there evidence of support or cooperation between multiple institutional departments, as applicable?

Review Criteria Specific to Research Translation Core

The Research Translation Core score will be based on review criteria described below and its Contribution to Overall SRP Center (see "Additional Review Criteria - Research Projects and Cores” below).

Objectives (Research Translation Core)

Are the objectives of the Research Translation Core appropriate to the Center? Are the approaches and methods proposed adequate to achieve objectives? Does the Research Translation Core promote and/or enhance interactions among the Center components and identify research translation opportunities on a per-project basis?

Qualifications (Research Translation Core)

Are the qualifications of proposed personnel adequate to conduct the activities described for the core? Do proposed personnel have the appropriate science and policy background to effectively translate findings from all research projects? Do they have an established track record for effectively working with science and public health experts, as well as communities (as applicable)?

Communication (Research Translation Core)

Is there a plan for communicating with the SRP at NIEHS and with other SRP RTCs? Is there a plan for coordinating with the Administrative Core, Community Engagement Core, Training Core, and Research Support Cores (as applicable)?

Partnering with Government (Research Translation Core)

Is the proposed plan to partner with governmental agencies adequate? Does the proposed plan specify bi-directional interactions? For renewal applications, is there evidence that the aims of the Research Translation Core have been met for developing approaches for transferring research findings to appropriate audiences (e.g.,  EPA, EPA Regions, ATSDR, State and local professionals or other professionals) working in the field of hazardous waste management? Is there evidence that the transfer of research findings to these audiences has occurred?

Technology Transfer (Research Translation Core)

Is the proposed plan to identify technology transfer opportunities and to assist in the advancement of technologies into application appropriate?

Information Dissemination to Other End Users (Research Translation Core)

Is the proposed plan to communicate to broad audiences adequate? Is there a plan for identifying and engaging target audiences? Are there adequate commitment and support for the approach being developed? Are the communication tools selected appropriate for the intended audience?

Milestones (Research Translation Core)

Are milestones delineated, realistic and appropriate?

Review Criteria Specific to Community Engagement Core

The Community Engagement Core score will be based on review criteria below and its Contribution to Overall SRP Center (see "Additional Review Criteria - Research Projects and Cores” below).

Community (Community Engagement Core)

Is the community of interest clearly defined? Are the community's and academic partners' roles clearly described? Is there evidence of the community's acceptance as a partner in the core? Is the community an integral part of the activity? Is the approach appropriate according to community socioeconomic and cultural factors?

Objectives (Community Engagement Core)

Are the objectives of the core of high interest/priority to the community? Will the core lead to a mutually-beneficial, bidirectional relationship between the academic institution and the community?

Management Plan (Community Engagement Core)

Does the management plan adequately describe a process for maintaining transparent communications between the community and the academic partners throughout the entire process of the activity? Does the plan address methods of building and sustaining community partnerships and community participation?

Investigator and Environment (Community Engagement Core)

Does the investigator provide previous experience/evidence for conducting community engagement activities? Does the research environment enhance the likelihood of success?

Review Criteria Specific to Training Core

The Training Core score will be based on review criteria below and its Contribution to Overall SRP Center (see "Additional Review Criteria - Research Projects and Cores” below).

Objectives (Training Core)

Are the objectives, design, and direction for the training appropriate to the Center? Are the approaches and methods proposed adequate to develop training curriculum, courses, and collaboration that provide the trainees with opportunities to interface with different disciplines? Does the Training Core reflect the interdisciplinary nature of the Center?

Qualifications (Training Core)

Does the Training Core Leader demonstrate experience in the development of training programs? Does the Training Core Leader encourage the trainees to participate in professional development and/or leadership opportunities? Does the Training Core Leader appear to devote adequate time to the trainees while balancing their own professional duties as a researcher/administrator? Does the Training Core Leader provide a plan for communicating with SRP about its training activities and providing information about the trainees to the SRP, such as trainees’ scientific or related fields, their academic and professional careers, and their leadership skills and experiences? For renewal applications, is the tracking of trainees (e.g. in CareerTrac) adequate and have they demonstrated commitment to tracking/reporting trainee accomplishments?

Recruitment and Selection (Training Core)

Are plans for the recruitment and selection of graduate students and post-doctoral researchers appropriate? Are all the trainees either directly supported by the Center or performing research/activities supported by the Center listed within the Training Core?

Environment (Training Core)

Is the institutional commitment adequate? Are the quality of the facilities and the availability of courses appropriate to the Center? Is there an availability of research support for graduate and post-doctoral training?

Review Criteria Specific to Research Support Core(s)

The Research Support Core(s) score(s) will be based on review criteria described below and its Contribution to Overall SRP Center (see "Additional Review Criteria - Research Projects and Cores” below).

Objectives (Research Support Core)

Are the objectives of the Research Support Core(s) appropriate to the Center? Are the approaches and methods proposed adequate to achieve objectives? Does the Research Support Core promote and/or enhance interactions among the Center components?

Utility to Center (Research Support Core)

Does each Research Support Core provide essential facilities or service for two or more of the Research Projects judged to have substantial scientific merit? Is the projected use sufficient to warrant establishment of the core? Are the core facilities contributing to the overall research activities of the Center? Is there evidence of enhanced efficiencies (including cost) afforded by the core?

Quality Assurance Statement (Research Support Core)

Is the Quality Assurance Statement for cores providing quantitative analyses adequate?

Prioritization (Research Support Core)

Is there a prioritization plan for use of core facilities/services?

Qualifications (Research Support Core)

Does the staff have the appropriate experience and level of commitment?

Additional Review Criteria – Research Projects and Cores

As applicable for the project/core 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.

Contribution to SRP Center (applies to all Projects and Cores)

Does the project/core contribute scientifically to the proposed Center’s problem-solving goals (i.e., the importance of the ideas or aims, the rationale and originality of the approach, the feasibility of the methods, and the value of the result)?

Will the specific scientific objectives of each project/core benefit significantly from, or depend upon, collaborative interactions with other projects in the Center (i.e., objectives that can be uniquely accomplished, specific contributions to the accomplishments of objectives in other projects, and objectives that can be accomplished with greater effectiveness and/or economy of effort)?

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

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

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

Additional Review Considerations – Research Projects and Cores

As applicable for the project/core 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.

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).  For research projects, the reviewers will comment on whether the "Investigator-Initiated Research Translation" plan is reasonable.  

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 National Institute of Environmental Health Sciences, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

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

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

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 Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

Note: A report of attendees at the annual meeting is required in the non-competing continuation progress report.     

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 Center Telephone: 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)

Danielle Carlin, Ph.D., DABT
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-1409
Email: danielle.carlin@nih.gov

Heather Henry, Ph.D.
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-5330
Email: henryh@niehs.nih.gov

William A. Suk, Ph.D., MPH
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-0797
Email: suk@niehs.nih.gov

Peer Review Contact(s)

Sally E. Tilotta, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-1446
Email: sally.tilotta@nih.gov   

Financial/Grants Management Contact(s)

Lisa Archer Edwards, M.B.A.
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-0751
Email: archer@niehs.nih.gov

Michelle Victalino
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-316-4666
Email: victalinom@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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