and Human Services (HHS)
EXPIRED
Participating Organization(s) |
National Institutes of Health (NIH) |
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-12-003 |
Related Notices |
|
Funding Opportunity Announcement (FOA) Number |
RFA-ES-13-001 |
Companion Funding Opportunity |
None |
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 disciplines; as well as cores tasked with administrative, community engagement, research translation, research support, and training 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. |
Posted Date |
November 15, 2012 |
Open Date (Earliest Submission Date) |
March 8, 2013 |
Letter of Intent Due Date(s) |
March 8, 2013 |
Application Due Date(s) |
April 10, 2013, by 5:00 PM local time of applicant organization. |
AIDS Application Due Date(s) |
Not Applicable |
Scientific Merit Review |
October 2013 |
Advisory Council Review |
January 2014 |
Earliest Start Date |
April 2014 |
Expiration Date |
April 11, 2013 |
Due Dates for E.O. 12372 |
Not Applicable |
This FOA uses NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.
Required Application Instructions
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission
Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
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 disciplines. Applicants responding to this Funding Opportunity Announcement (FOA) are expected to design a research Center that integrates environmental health sciences with related environmental science and engineering disciplines (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 and environmental sciences, 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.
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. 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:
Hazardous substances found at Superfund sites. (Applicants may refer to the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) Priority List website for information on hazardous substances associated with Superfund sites: http://www.atsdr.cdc.gov/SPL/index.html).
Hazardous breakdown products of the above substances formed in environmental media by physical, chemical or biological (e.g., plants, microorganisms) processes.
Hazardous metabolites of the above substances or their breakdown products formed after exposure in humans or in experimental animal models.
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.
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.
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.
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 The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. |
Funds Available and Anticipated Number of Awards |
The NIEHS intends to commit $10 million in FY 2014 to fund up to five SRP grants in response to this FOA subject to the availability of funds. |
Award Budget |
A new application may request a budget for direct costs of up to $1.7 million dollars for the first year. Renewal applications may request a budget for direct costs of up to $2.1 million dollars for the first year. Third party F&A is not included in the direct cost limitation. Cores: The sum of Direct Costs for the first year of the award for the Administrative, Research Translation, Community Engagement, and Training Cores cannot exceed 20% of the total Direct Costs of the Center ($340,000 Direct Costs for New Applicants; $420,000 Direct Costs for Renewal Applicants). In addition, the following Direct Cost limitations apply.
Budgets should include funds for travel to attend the SRP annual meeting. 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.
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.
Non-domestic (non-U.S.) Entities (Foreign Institutions) are
not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible
to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
Applicant organizations must complete the following registrations
as described in the SF424 (R&R) Application Guide to be eligible to apply
for or receive an award. Applicants must have a valid Dun and Bradstreet
Universal Numbering System (DUNS) number in order to begin each of the following
registrations.
All Program Directors/Principal Investigators (PD(s)/PI(s)) and
component Project Leads that are not yet registered in eRA Commons must work
with their institutional officials to register. Also, institutional officials
at the applicant organization should ensure that the eRA Commons account for
the contact PD/PI is affiliated with their organization.
eRA Commons accounts are necessary to use ASSIST to prepare and submit
applications.
All registrations must be completed by the application due date. Applicant
organizations are strongly encouraged to start the registration process at least
6 weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the 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"
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (see NIH Grants Policy Statement), except for submission:
Only one application per accredited institution of higher education (normally identified by having a unique DUNS number or NIH IPF number) is allowed.
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.
Applicants will use NIH’s ASSIST system, rather than Grants.gov’s downloadable forms, to prepare and submit applications through Grants.gov to NIH.
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.
On January 30, 2013 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/srp/funding/rfa.cfm).
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
The letter of intent should be sent to:
Linda Bass, PhD
Scientific Review Officer
Scientific Review Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233; Mail drop K3-03
Research Triangle Park, NC 27709
For Courier delivery:
530 Davis Drive, Room 3074
Research Triangle Park, NC 27713
Telephone: 919-541-1307
Fax: 301-451-5715
Email: [email protected]
Please note that submission of the letter of intent by email is preferred.
Applications submitted to this FOA will be made up of a collection of application components. All applications will include an Overall component that provides information regarding the application as a whole, as well as a combination of additional component types. Applicants should select the appropriate application component types in ASSIST when preparing applications. Note, eRA Commons accounts are necessary to use ASSIST to prepare and submit applications.
Component Types Available in ASSIST |
Research Strategy/Program Plan Page Limits |
Overall |
12 |
Project (Use for each project, including community engagement research projects. Note: projects will be reviewed in the order in which they were entered into ASSIST.) |
12 |
Core (Use for Administrative, Research Translation, Community Engagement, Training, and Research Support Cores. Please enter in ASSIST using this order.) |
12 |
Additional page limits described in the SF424 Application Guide and the Table of Page Limits must be followed unless otherwise specified:
The following table provides instruction clarification for the information required in the Overall component of a multi-project application versus information required for all other components included in the application.
Form |
Overall component |
All other components |
SF424 (R&R) cover |
Complete entire form |
Complete only the following fields: Applicant Information |
Project /Performance Site Location(s) |
Enter primary site only. |
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. |
Budget |
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. |
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. |
Research & Related Senior/Key Person Profile |
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. |
Use Project Role of Other with Category of Project
Lead and provide a valid eRA Commons ID in the Credential field in the
Project Director/Principal Investigator section. |
Research & Related Other Project Information |
Follow standard instructions. |
Human Subjects: Answer only the Are Human Subjects
Involved? and Is the Project Exempt from Federal regulations? questions. |
PHS 398 Cover Page Supplement |
Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component. |
Enter Human Embryonic Stem Cells in each relevant component. |
PHS 398 Research Plan |
For Resubmission and Revision applications, an Introduction to Application is required in the Overall component. |
For Resubmission and Revision applications, an Introduction to Application is allowed for each component. |
PHS 398 Research Plan |
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 modifications:
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. |
|
In order to be considered for funding, each application must have a minimum of two biomedical and two environmental science research projects as well as an Administrative Core, Research Translation Core, Community Engagement Core, and Training Core. Research Support Cores are optional.
Applications must successfully meet these minimum requirements without exceeding a total of 12 components. That is, the total number of components including projects, four required cores (Administrative Core, Research Translation Core, Community Engagement Core, and Training Core), and optional Research Support Core(s), cannot exceed 12).
Please see section below for descriptions of the Center components.
Other Project Information Component
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 overall indication what the Center proposed. For example, the summary should describe the hazardous substances, study sites, model organisms/biological systems, etc. In addition, the Center should highlight aspects of the proposal 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.
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.
PHS398 Research Plan
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, in the Overall Research Strategy section, 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). 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 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. A Resource Sharing Plan should be included, as appropriate, for the overall Center for data-sharing activities that involve multiple projects and/or cores. This plan should be included within the "Overall" component in ASSIST. This plan for sharing data should describe coordinating efforts of the overall Center regarding sharing of data within and/or beyond the SRP Center. Information included in the overall Center should complement but not duplicate project/core Resource Sharing Plans.
The SRP requires a minimum of two biomedical and two environmental science research projects. Applicants may include, as part of their Center, Community Engagement Research Project(s), which are hypothesis-driven research projects address 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 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 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.
Other Project Information Component
Other Attachments. Each project should include a "Relation to Overall Center" statement included in each of the Project "SF 424 Research and Related Other Project Information" section under the "Other Attachments Section". This should be loaded as a file titled "Relation to Overall Center" under the "SF424 (R&R) Research & Related Other Project Information" under "Other Attachments." 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.
PHS398 Research Plan (Biomedical and Environmental Science Research Projects)
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 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 research projects include, but would not be limited to: civil/environmental engineering, geology, ecology, microbiology, fate and transport studies, hydrogeology, remediation and detection sciences.
Per PHS398 instructions, 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:
Other Project Information (Admin Core)
Other Attachments. The core should include a "Relation to Overall Center" statement included in the "SF 424 Research and Related Other Project Information" section under the "Other Attachments Section". This should be loaded as a file titled "Relation to Overall Center" under the "SF424 (R&R) Research & Related Other Project Information" under "Other Attachments." 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.
Research & Related Senior/Key Person Profile (Admin 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. Through the required Administrative Core, the Center Director provides leadership and guidance in fulfilling the stated objective of his or her 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. The structure of this core will provide the Center Director with a mechanism for:
PHS398 Research Plan (Admin Core)
Research Strategy. Within the Research Strategy, the application should describe how the Administrative Core will take a leadership role in ensuring the synthesis of findings and activities from research projects and cores towards solving the central problem proposed by the Center. In addition, direct lines of communication between the Administrative Core and Research Translation Core (as well as with the other cores, as appropriate) should be delineated, as all of these cores serve critical roles for Center integration.
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 projects within the Center. The plan should also describe their strategy for coordinating research activities and research translation activities; the integration of cross-disciplinary research; the oversight of fiscal and resource management; and 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.
Note: When preparing your application in ASSIST, please
use the component type "Core". The Center Director must commit a
minimum of 1.8 person months to the administration of the Center. See Section II. Award Information for cost
limitations.
R&R Budget
Funds for travel by appropriate staff (i.e., Center Director, Project/Core Leaders, Business Manager, 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 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.
Other Project Information (Research Translation Core)
Other Attachments. This core should include a "Relation to Overall Center" statement included in the "SF 424 Research and Related Other Project Information" section under the "Other Attachments Section". This should be loaded as a file titled "Relation to Overall Center" under the "SF424 (R&R) Research & Related Other Project Information" under "Other Attachments." 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.
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.
PHS398 Research Plan (Research Translation Core)
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);
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 translation activities to SRP staff at NIEHS; and
d) Cross-Center communication: communicating with RTCs from other SRP Centers.
In the Research Strategy section, applicants are expected to delineate a plan 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.
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 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.
Note: When preparing your application in ASSIST, please use the component type "Core". See Section II. Award Information for cost limitations.
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.
Other Project Information (Community Engagement Core)
Other Attachments. The CEC should include a "Relation to Overall Center" statement included in the "SF 424 Research and Related Other Project Information" section under the "Other Attachments Section". This should be loaded as a file titled "Relation to Overall Center" under the "SF424 (R&R) Research & Related Other Project Information" under "Other Attachments." 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.
PHS398 Research Plan (Community Engagement Core)
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, and a process to guarantee effective bi-directional exchange of needs, recommendations, and results. 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:
Note: When preparing your application in ASSIST, please use the component type "Core". If proposing a Community Engagement Project, please use the component type "Project". See Section II. Award Information for cost limitations.
The SRP requires applicants to include a Training Core, led by a Training Core Leader, to support graduate and postdoctoral level cross-disciplinary training in fields related to environmental health and environmental science/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. 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 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).
Other Project Information (Training Core)
Other Attachments.
The following attachments should be prepared and uploaded:
PHS398 Research Plan (Training Core)
Research Strategy. 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. 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.
R&R Budget (Training Core)
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 carried on outside the structured Training Core, and may occur within a project or another core. In these instances, stipends and other related training costs (e.g., equipment, supplies) should be part of the project or core budgets rather than the Training Core budget. For budget purposes, trainees should be listed in the appropriate project/core budget pages, and should not be listed as key personnel.
Note: When preparing your application in ASSIST, please use the component type "Core". See Section II. Award Information for additional cost limitations.
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.
PHS398 Research Plan (Research Support Cores)
Research Strategy. In the "Research Strategy", the applicant must include the description of these cores, 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/Resubmissions Applications. For renewals, summarize activities carried out during the preceding performance period. Include core utilization by the individual Research Projects.
Other Project Information Component (Research Support Cores)
Other Attachments.
1- Quality Assurance Statements will be necessary ONLY for Research Support Cores that provide analytical, quantitative services to the applicant’s Center. If required, the Quality Assurance Statement should be included in the Other Attachments of the SF424 Research & Related Other Project Information . This should be loaded as a file titled "Quality Assurance Statement" under the "SF424 (R&R) Research & Related Other Project Information" under "Other Attachments." 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:
2- Each individual component (projects and cores) should include a "Relation to Overall Center" statement included in each of the Project/Core "SF 424 Research and Related Other Project Information" section under the "Other Attachments Section".This should be loaded as a file titled "Relation to Overall Center" under the "SF424 (R&R) Research & Related Other Project Information" under "Other Attachments." In this statement, clearly state the relevance to the project/core to the goals of the overall Center, how this project/core integrates with other projects and cores, and how the findings/activities of this project/core assist in solving the problem(s) that the Center is addressing. Interactions with the Research Translation Core should also be included.
Note: When preparing your application in ASSIST, please use the component type "Core".
Not Applicable
Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.
Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.
Applicants are responsible for viewing their application before the deadline in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
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.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.
Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
For this particular announcement, note the following:
The initial review for scientific and technical merit will emphasize two major aspects: (1) Overall Impact - Center; and (2) Overall Impact - Research Projects and Cores.
1) Overall Impact - Center
Is the review of the SRP Center application, i.e. the multi-project grant as an integrated research effort of projects and cores focused on a problem-based, solution-oriented theme? Reviewers will provide an overall impact/priority score in consideration of the Center's Significance, Investigator(s), Innovation, Approach, Environment, and Integration.
2) Overall Impact - Research Projects and Cores
Is the review of each research project, Research Support Core and other core components independently? For research projects, reviewers will provide an overall impact/priority score in consideration of the five Scored Review Criteria (Significance, Investigator(s), Innovation, Approach, and Environment) and its Contribution to Overall SRP Center. All cores are scored based on review criteria specific to that core (described below) and their Contribution to Overall SRP Center.
Reviewers will consider each of the review criteria below in the determination of scientific merit. 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. Is 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?
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.
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-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?
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 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 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.
Revisions
Not Applicable
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.
In addition to the Overall Impact score for the Center, reviewers will provide an overall impact/priority 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).
Reviewers will provide an overall impact/priority 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. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field. The Contribution to Overall SRP Center criterion is not scored separately, but is considered in the determination of the overall impact/priority 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 core 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?
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 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?
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 and Community Engagement Core (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? Is there evidence that the aims of the Research Translation Core for developing approaches for transferring research findings to appropriate audiences such as EPA, EPA Regions, ATSDR, State and local professionals or other professionals working in the field of hazardous waste management have been met? 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?
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?
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?
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?
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?
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/priority 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.
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.
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:
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH Grants
Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to the DUNS, SAM
Registration, and Transparency Act requirements as noted on the Award
Conditions and Information for NIH Grants website.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
Cooperative Agreement Terms and Conditions of Award
Not Applicable
When multiple years are involved, awardees will be required to submit the annual non-competing progress report (PHS 2590 or RPRR) 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.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
Grants.gov
Customer Support (Questions regarding Grants.gov registration and
submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: [email protected]
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]
eRA Commons Help Desk (Questions regarding eRA Commons
registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: [email protected]
Danielle Carlin, Ph.D., DABT
National Institute of Environmental Health Sciences (NIEHS)
Telephone: (919) 541-1409
Email: [email protected]
Heather Henry, Ph.D.
National Institute of Environmental Health Sciences (NIEHS)
Telephone: (919) 541-5330
Email: [email protected]
William A. Suk, Ph.D., MPH
National Institute of Environmental Health Sciences (NIEHS)
Telephone: (919) 541-0797
Email: [email protected]
Linda Bass, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: (919) 541-1307
Email: [email protected]
Lisa Archer Edwards, M.B.A.
National Institute of Environmental Health Sciences (NIEHS)
Telephone: (919) 541-0751
E-mail: [email protected]
Michelle Victalino
National Institute of Environmental Health Sciences (NIEHS)
Telephone: (919) 316-4666
E-mail: [email protected]
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.
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