Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute of Environmental Health Sciences (NIEHS)
Funding Opportunity Title	Superfund Hazardous Substance Research and Training Program (P42)
Activity Code	P42 Hazardous Substances Basic Research Grants Program
Announcement Type	Reissue of RFA-ES-10-010
Related Notices	November 15, 2012 - This RFA has been reissued as RFA-ES-13-001. November 23, 2011 - Clarification of Resource Sharing Plans for RFA ES-12-003 and Announcement of Funding Opportunity Web Seminar. See NOT-ES-12-003.
Funding Opportunity Announcement (FOA) Number	RFA-ES-12-003
Companion FOA	None
Number of Applications	Only one application per accredited institution of higher education will be accepted. Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.113, 93.143
FOA 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 non-biomedical 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 include: (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	October 13, 2011
Letter of Intent Due Date	March 11, 2012
Application Due Date(s)	April 10, 2012
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	October 2012
Advisory Council Review	January 2013
Earliest Start Date(s)	April 2013
Expiration Date	April 11, 2012
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. While some links are provided, 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 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

Purpose

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 non-biomedical 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 (geochemical, ecological sciences). The goal of the NIEHS SRP Center is to improve public health by supporting integrative, multidisciplinary research incorporating the following:

• Responsiveness to Mandates: SARA Section 311(a) Hazardous Substances Research and Training, authorizes NIEHS to create a basic research and training program for the development of:

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.

Research and supporting activities from each Center should address at least one or more of these mandates.

• Relevance to Superfund: SRP considers the diverse research and information needs of its stakeholders as important criteria for determining relevance. The SRP’s primary stakeholders are its sister Superfund programs at the U.S. Environmental Protection Agency (EPA, http://www.epa.gov/superfund/index.htm) and Agency for Toxic Substances and Disease Registry (ATSDR, http://www.atsdr.cdc.gov). 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. SRP’s ultimate goal is to protect human health by providing a rigorous scientific basis for effective decision-making by these stakeholders. Consequently, SRP-funded research is expected to provide fundamentally sound science, while providing data, information, and knowledge to inform the risk assessment and remediation management processes for hazardous waste sites. Therefore, investigators should seek input from stakeholders during proposal development and identify critical issues for which fundamental science is needed. They should clearly describe how results gained from the studies are relevant to Superfund. They should also indicate how these studies will lead to better decision making for risk assessors and remediation managers at Superfund sites and/or addressing uncertainties involved in understanding disease/dysfunction for communities impacted by hazardous substances.
• Problem-based, Solution-oriented Research Theme: As an integrated research program, SRP Centers have the opportunity to tackle complex biomedical and non-biomedical issues identified by stakeholders, bringing a mechanistic understanding to solve some of the vexing problems associated with Superfund and other similar hazardous waste sites. Applicants are encouraged to design Centers where the research team is developed around mechanistic research that will contribute to solving a particular problem (or set of problems) related to health effects, risk, detection, and/or remediation of hazardous substances.
• Innovation: SRP strives to push the boundaries of science using the newest technologies and challenging the current paradigms. SRP firmly supports trans-disciplinary research, through the synthesis and extension of disciplinary boundaries, that adapts technologies and approaches from one field and applies them to other fields in order to solve challenging environmental health problems. Forward-looking or anticipatory research is critical to identify and address future stakeholder needs. This may include utilizing cutting-edge research tools, developing new risk frameworks, or devising more sustainable solutions to address issues at sites affected by hazardous substances.
• Research Translation: SRP is committed to fostering the translation of the scientific accomplishments emanating from an SRP Center to its stakeholders. A required Research Translation Core (RTC) will facilitate and coordinate communication of the results, accomplishments, and implications of the Center’s research to stakeholders in a context that makes the research applicable to the target audience. In addition, the SRP encourages project investigators to coordinate with the RTCs to translate their research products to end-users.
• Community Engagement: The SRP views Community Engagement (defined as the bidirectional interaction between community stakeholders and the Center) as an effective way to inform and advance science for public health protection. Community Engagement connects the Center’s science with issues that are identified by communities and complements the research strengths and theme of the Center. All applicants are required to include 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. SRP also encourages applicants to include, as part of their Center, a community engagement research project.
• Training: The SRP requires applicants to include a Training Core to support graduate and postdoctoral level cross-disciplinary training in fields related to environmental health and environmental science/engineering. The SRP regards the Training Core as a vital component to the mentorship, education, and training of the next generation of environmental health and science professionals.

Applicants are encouraged to refer to the SRP’s Strategic Plan (http://tools.niehs.nih.gov/srp/about/register.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 Grant is defined by the SRP Mandates. Research and supporting activities under this FOA may utilize a variety of approaches to achieve SRP mandates:

1) Health Effects Research: 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, 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.

2) Risk Assessment Research: 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, susceptibility, 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) Detection Research: 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) Remediation Research: 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 at hazardous waste sites. 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 encourages health effects researchers to collaborate with remediation scientists to assess and mitigate unintended toxicological implications of the remediation.

Examples of Research Topics. As outlined or specified in the Strategic Plan, 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) in identifying problems. Hence, applicants are encouraged to engage stakeholders as they develop research projects 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 (see "Research Projects" section below). For a listing of research areas of interest to the SRP and its stakeholders, please refer to the Suggested Research Topics 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 sister Superfund agencies (EPA and ATSDR).

The Strategic Plan also states/requires/directs that SRP will be proactive in achieving coverage and balance across mandate areas, contaminants, and exposure scenarios placing emphasis on stakeholders critical needs. Therefore, the applicant is strongly encouraged to visit the SRP website’s Additional Resources page at http://www.niehs.nih.gov/research/supported/srp/funding/rfa_resources.cfm to determine how research that may be proposed fills research 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, asbestos, 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;
• hazardous breakdown products of the above substances formed in environmental media by physical, chemical or biological (e.g., plants, microorganisms) processes; and
• 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 following Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) Priority List website for information on hazardous substances that are relevant to the US Environmental Protection Agency (EPA) Superfund program and to the Agency for Toxic Substances and Disease Registry (ATSDR): (http://www.atsdr.cdc.gov/cercla).

There are a number of contaminants that are of emerging concern to Superfund. These substances include, but are not limited to:

• high production volume agents with demonstrated potential for human health and environmental impact (e.g., "high priority" for risk-based priority decisions http://www.epa.gov/hpvis);
• chemicals presumed to be toxic based on structural similarity to the CERCLA Priority List of hazardous substances and likely to cause exposures from a point source; and
• environmental contaminants of emerging interest due to: rapidly increasing production volume combined with suspected toxicological and bioaccumulative characteristics or a change in toxicity risk or regulatory status.

SRP recognizes the important role of proactive research on emerging contaminants. NOTE: as with all projects, there should be a clear description of how results gained from studies 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 disease/dysfunction for communities impacted by hazardous substances.

Activities on Hazardous Waste Sites. Whether through project research or core activity, Centers are strongly encouraged to utilize opportunities for interactions at Superfund and other managed hazardous waste sites (EPA Office of Solid Waste and Emergency Response’s map of cleanup sites, http://iaspub.epa.gov/apex/cimc/f?p=255:63:1588319634654771). 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:

• propose a procedure for coordinating and documenting site activities including record of the research conducted, sample collected, or translation/engagement activities; and
• delineate procedures for bi-directional communication and outcome reporting to appropriate site officials, site managers, and SRP staff at NIEHS.

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

Center Components

The SRP requires a minimum of two biomedical and two non-biomedical research projects. 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 non-biomedical 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. Non-biomedical research projects include, but would not be limited to: civil/environmental engineering, geology, ecology, microbiology, fate and transport studies, hydrogeology, remediation and detection sciences. Research should emphasize a balance of basic and applied research that contributes to the problem-based, solution-oriented goal of the Center. The collection of projects should, therefore, bring together biomedical and non-biomedical expertise necessary to address the central problem and to orient research such that the Center findings provide a clear step towards identifying solutions to these problems. Projects should be hypothesis-driven or product-oriented research.

Applicants may include, as part of their Center, Community Engagement Research Project(s). These 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 non-biomedical projects, depending on the theme of the research project. These projects must include a plan for adhering to the community-based participatory processes of planning, implementing, and communicating pertinent research results (detailed in "Application Guidelines" found at http://www.niehs.nih.gov/research/supported/srp/funding/rfa.cfm). Community engagement research projects will be reviewed with the same criteria as research projects along with additional review criteria (see Section V. Application Review Information).

The SRP Strategic Plan emphasizes the importance of investigator-initiated research translation as a means to achieve SRP impact. Project researchers should, therefore, be actively engaged with the Research Translation Core to identify and execute an appropriate plan to translate research project outcomes to potential end-users. These research translation plans should be described in the "Resource Sharing Plan" section of each project and cross-referenced in the Research Translation Core "Research Strategy." Additional instructions for the "Resource Sharing Plan" are provided in the Application Guidelines document, found at http://www.niehs.nih.gov/research/supported/srp/funding/rfa.cfm.

As described in the SRP Strategic Plan, it is important that applicants prioritize and address the most critical research areas to maximize relevancy of SRP. When preparing applications, applicants should, in turn, assemble teams to address research challenges within a given mandate area, contaminant, or exposure scenario with the greatest potential to support SRP s goal to protect human health and the environment from hazardous substances. As such, applications should not overly-emphasize one mandate area (e.g., health effects ) if another mandate area (e.g., remediation or detection technology) is the critical gap in knowledge most likely to prevent exposure to hazardous substances.

See Section III.3. for additional information about special eligibility requirements for research projects.

Administrative Core (Required):

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:

• planning and coordinating research activities
• integrating cross-discipline research
• overseeing fiscal and resource management
• quality management

To demonstrate how the core will achieve its administrative functions, the applicant will include a description of the lines of communication among the Center scientists and core leaders, and a description of the mechanisms to be used to encourage and ensure the integration and interaction between the biomedical and non-biomedical projects within 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.

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

• the scientific merit of the research
• the relevance and importance of the individual components to the goals of the Center
• the integration of research across disciplines
• the effectiveness of research translation activities in linking projects and stakeholders
• the appropriateness of community engagement and training activities.

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 exptertise for EAC members. New applicants should not list names of anticipated EAC members.

Research Translation Core (Required):

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. Therefore, 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.

The RTC will have the following components 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

For all proposed activities, the RTC must describe goals, identify specific projects/cores involved, include a plan for coordinating these activities, delineate a timeline with milestones for achievement of these goals, and a description of the process for outcome-reporting to relevant stakeholders.

1) Communicating within SRP: NIEHS requires the RTC to communicate both within its institutional Center, as well as the greater SRP community (other SRP Centers and SRP staff at NIEHS). This role has implications on four important levels:

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.

SRP requires a plan for coordinating activities at all four levels. 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 each applicant’s plan delineates 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 non-biomedical 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), 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. 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. To reach these stakeholders, a variety of mechanisms would be appropriate activities for the RTC including:

• sponsorship of a one-day workshop for regional waste management professionals to tackle issues related to SRP-Center research;
• development of project-relevant factsheets that translate complex research findings for the lay public (including language translation); and
• development of accessible and advanced communication tools (e.g. internet-based or GIS-based technologies) to enhance transparency in environment and health interactions relevant to the Center’s research.

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.

Additional information about the Research Translation Core is located in the "Application Guidelines" found at http://www.niehs.nih.gov/research/supported/srp/funding/rfa.cfm. (See Section III.3. for budget details).

Community Engagement Core (Required):

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. 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.

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. Examples of appropriate CEC activities include but are not limited to:

• conducting community-based needs assessment;
• partnering with Tribes in determining exposure pathways relevant to their traditional and cultural practices;
• assisting with community-based exposure assessment (e.g., teaching community members how to use personal sensors or exposure assessment devices);
• assisting a community in accessing pertinent information or translating materials into the community’s native language;
• providing scientific expertise in response to a community s questions;
• developing risk communication tools/methods tailored to the community partner;
• providing "train-the-trainer" workshops for risk communication or information dissemination;
• conducting coursework and community-based service projects.

As an outgrowth of these 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.

Each CEC will include a timeline with milestones, measurable outcomes, and a process to guarantee effective bi-directional exchange of needs, recommendations, and results. CECs must include a plan for adhering to community-based participatory processes of planning, implementing, and communicating pertinent results (detailed in "Application Guidelines" found at http://www.niehs.nih.gov/research/supported/srp/funding/rfa.cfm). (See Section III.3. for budget details).

Training Core (Required):

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 non-biomedical areas should be encouraged to understand how their research fits into the context of environmental health sciences and vice versa for biomedical trainees.

The following are recommended Training Core activities:

• conduct and promote interdisciplinary research/activities among the trainees within the Center, and as appropriate, with other trainees from outside the Center;
• provide the trainees with opportunities to develop both the trainees current research/activity programs, as well as their professional development;
• participate in activities which may include: serving in leadership roles, presenting their research or activities to the Center s institution and/or outside organizations, and participating in workshops/conferences that promote professional development (e.g., resume or scientific writing and interviewing skills);
• facilitate practical opportunities for coordination or collaboration among other grantees and for communicating research outcomes to diverse audiences (e.g., the public, their peers, and experts in the field) so that the trainees learn how to explain their work in a manner easily understood by the intended audience whether the audience be the public or professionals in other areas of science;
• host events within their Center to promote collaboration among the trainees (e.g., seminars or field days); and
• coordinate trainee participation in the Community Engagement and Research Translation Cores.

The Training Core should provide reporting information about the Center’s trainees to the SRP. The core should also have direct 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 and to the public. This information should be reported as relevant activities/events occur and summarized in annual progress reporting.

In keeping with the NIH efforts to train members of minority groups, and those with disabilities, applicants are encouraged to consider these candidates in their recruitment efforts. (See Section III.3. for budget details).

Research Support Cores (Optional):

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 two or more research projects. Typical core facilities include laboratory facilities, biostatistics and/or bioinformatics support, or analytical equipment and services. The applicant must include in his/her 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. (See Section VI. Award Administration Information for additional requirements.)

See Section III.3. for additional information about special eligibility requirements for cores.

Funding Instrument	Grant
Application Types Allowed	New Renewal Resubmission The OER Glossary and the PHS398 Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The NIEHS intends to commit $8.5 million in FY 2013 to fund up to four SRP grants in response to this FOA subject to the availability of funds.
Award Budget	A new applicant may request a budget for direct costs of up to $1.7 million dollars for the first year. Applicants submitting renewal applications may request a budget for direct costs of up to $2.1 million dollars. Please see Section III.3. for additional cost limitations on cores. Third party F&A is not included in the direct cost limitation. For all applicants, budgets submitted in subsequent years may not exceed an escalation of two percent on recurring direct costs.
Award Project Period	New applicants may propose an award period of up to 4 years. Renewal applicants 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

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

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

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

Per our legislative Authority, ONLY Higher Education Institutions may apply for P42.

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.

Common Fund/Roadmap text, Collaborative Research, or Projects Greater than 5 years Duration: See instructional documents in the NIH Guide Publishing System for the text to insert.

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 PHS398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

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

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

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

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the 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 the purposes of this FOA, the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) will be referred to as the "Center Director."

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

Only one application per accredited institution of higher education (normally identified by having a unique DUNS number or NIH IPF number) is allowed.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the PHS398 Application Guide.

Applicants must propose a multi-project, multidisciplinary research Center that addresses a problem-based, solution-oriented theme that is related to the goals of the SRP.

The applicant must name a Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) as the designated Center Director of the SRP multi-project grant to provide scientific and administrative leadership to the Center. The Program Director(s)/Principal Investigator(s) must commit a minimum of 1.8 person months to the administration of the Center.

In order to be considered for funding each application must successfully meet the following minimum requirements without exceeding a total of 12 components (i.e. the total number of projects, including the four required cores and optional Research Support Core(s), cannot exceed 12):

• Two Approved Biomedical Research Projects. These projects address biomedical or human health-related implications of hazardous substances. This includes: mechanistic-based toxicology studies, human risk assessment, epidemiology, genetic susceptibility, computational toxicology, and biomedical engineering.
• Two Approved Non-Biomedical Research Projects. These research projects should address environmental science or engineering implications of hazardous substances. This includes: engineering, geology, ecology, microbiology, fate and transport studies, hydrogeology, remediation, and detection sciences.
• An Approved Administrative Core. The Administrative Core must include an external advisory committee which should provide oversight and advice to the Center Director in accomplishing the Center goals. The Administrative Core is limited to $150,000 direct costs in the first year, with subsequent years subject to the standard two percent cost escalations allowed by NIH (see "Cost Limitations" below).
• An Approved Research Translation Core. The Research Translation Core must include plans for: (1) communicating within SRP, (2) partnerships with government agencies, (3) technology transfer, and (4) information dissemination to other end-users. The Research Translation Core is limited to $150,000 direct costs in the first year, with subsequent years subject to the standard two percent cost escalations allowed by NIH (see "Cost Limitations" below).
• An Approved Community Engagement Core (CEC). The Community Engagement Cores are limited to $100,000 direct costs in the first year, with subsequent years subject to the standard two percent cost escalations allowed by NIH (also see "Cost Limitations" bullet below). CECs must include a "Community Engagement Statement" to describe how community engagement activities will be conducted in partnership with the target community.
• An Approved Training Core. The direct costs for the Training Core are not to exceed $100,000 direct costs for new applicants and $125,000 direct costs for renewal applicants (also see "Cost Limitations" bullet below). Individuals in the training positions must be considered employees of the institution and not trainees receiving stipends as in National Research Service Award programs. 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 (See "Cost Limitations" below).
• Cost Limitations.
  • Center: A New Applicant may request a budget for Direct Costs of up to $1.7 million dollars for the first year. Applicants submitting Renewal Applications may request a budget for Direct Costs of up to $2.1 million dollars for the first year.
  • Cores: The sum of Direct Costs for 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:
    • Administrative Core - not to exceed $150,000 Direct Costs,
    • Research Translation Core - not to exceed $150,000 Direct Costs,
    • Community Engagement Core - not to exceed $100,000 Direct Costs; and
    • Training Cores (not to exceed $100,000 Direct Costs for New Applicants; or $125,000 Direct Costs for Renewal Applicants).

Centers may include Research Support Core(s) to provide services to at least two of the research projects. Research Support Cores are not required. If a Research Support Core(s) is included in the application, this core(s) will be counted among the 12-component limit.

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

It is critical that applicants follow the instructions in the PHS398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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

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

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

The letter of intent should be sent to:

Leroy Worth, 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 3080
Research Triangle Park, NC 27709
Telephone: 919- 541-0670
Fax: 301-451-5715
Email: worth@niehs.nih.gov

Please note that submission of the letter of intent by email is preferred.

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional paper copies of the application and all copies of the appendix files must be sent to:

Leroy Worth, Ph.D.
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 3080
Research Triangle Park, NC 27709
Telephone: 919- 541-0670
Fax: 301-451-5715
Email: worth@niehs.nih.gov

All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed.

For this FOA, a 12-page limit applies to the Center Introduction (part of Section II, the Overall Center Plan ) and the Research Strategy section of all projects and cores (part of Sections lll-Vlll).

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions in the SRP application guidelines: http://www.niehs.nih.gov/research/supported/srp/funding/rfa.cfm

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 PHS398 Application Guide. All projects and cores are required to include a Data Sharing Plan, a 1-paragraph description of how final research data and findings will be shared. Plans for investigator-initiated research translation should be described in this section emphasizing research translation components each Center is required to address: 1) Communicating within SRP; 2) Partnerships with Government Agencies; 3) Technology Transfer ; 4) Information Dissemination to Other End-users. (See Section I. Funding Opportunity Description Research Translation Core. ) These plans should be coordinated with the Research Translation Core and Administrative Core..

Appendix

Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide.

Part I. Overview Information contains information about Key Dates.

Information on the process of receipt and determining if your application is considered on-time is described in detail in the PHS398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

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 received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

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

The applications submitted in response to this FOA are complex, and the scientific and programmatic information needed to adequately assess a grant application is not fully accommodated within the instructions accompanying the PHS 398 form. Therefore, applicants need to follow the detailed guidelines that are provided in the Application Guidelines document, found on http://www.niehs.nih.gov/research/supported/srp/funding/rfa.cfm, to supplement the PHS 398 instructions.

Quality Assurance Statements will be necessary ONLY for Research Support Cores that provide analytical, quantitative services to the applicant s Center. Detailed guidelines are provided in the Application Guidelines document, found on http://www.niehs.nih.gov/research/supported/srp/funding/rfa.cfm.

It is the intent of the NIEHS to hold annual grantee meetings. Funds for travel by appropriate staff (i.e., Center Director, Project Investigators, Business Manager, and four trainees) to attend a three-day meeting shall be included in the Administrative Core’s budget for each year. It is also anticipated that the Community Engagement, Research Translation, and Training Core Leaders will convene at the annual meeting, and expenses for this travel should be included in their individual budgets. The location of the meeting site will rotate among the different grantees and Research Triangle Park, NC. A report of attendees at the annual meeting is required in the non-competing continuation progress report.

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 FOA, 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 its Contribution to Overall SRP Center.

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

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(s)/PI(s)) 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?

Innovation

Does the Overall SRP Center address an innovative hypothesis or critical barrier to progress in the understanding of the physical, chemical, and biological properties of hazardous substances in the environment?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Center? 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/priority score, but will not give separate scores for these items.

Integration of the SRP Center:

• Interdisciplinary Nature of Research Activities. Are the projects integrated around a problem-based, solution-oriented theme? Are there plans to effectively pursue interdisciplinary research objectives? Does the Center propose a plan for the development of interdisciplinary collaboration among all components of the Center? Is there evidence of integration and interaction of the non-health related research with the health-based research as it contributes to the central theme of the Center?
• Coordination and Cohesiveness. 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?
• Synergy of the Center. Is there strong synergy among the combined efforts of the various investigators within the overall Center? Is there evidence of meaningful interdisciplinary/multidisciplinary collaboration and synergistic potential among the research projects and cores (i.e., is the whole greater than the sum of the parts?)? Is the size 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 Center.

Renewals

For Renewals, the committee will consider the progress made in the last funding period, for example:

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

Revisions

Not Applicable.

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/priority score.

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

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

Resource Sharing Plans

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

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Overall Impact Research Projects and Cores

In addition to the Overall Impact score for the Center, reviewers will provide an overall impact/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).

Scored Review Criteria Research Projects

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

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

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?

Investigator(s)

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-PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Innovation

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

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?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Additional Review Criteria Research Projects and Cores

As applicable for the project/core proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/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 theme (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)?

Review Criteria Specific to Administrative Core:

• Objectives: 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: 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: 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 non-biomedical project interactions? Are interactions between projects, Research Translation Cores, and external partners/communities evident?
• External Advisory Committee: 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: 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: Is the institutional commitment adequate? Is there evidence of support or cooperation between multiple institutional departments, as applicable?

Review Criteria Specific to Research Translation Core:

• Objectives: 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?
• Qualifications: 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 with SRP: Is the proposed plan adequate for identifying research translation opportunities on a per-project basis? 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: 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: 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: 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: Are milestones delineated, realistic and appropriate?

Community-Based Participatory Processes (additional criteria applies only to Community Engagement Cores and 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/project? Is the community an integral part of the activity/research? Is the approach appropriate according to community socioeconomic and cultural factors?
• Are the objectives of the core/project of high interest/priority to the community? Will the core/project lead to a mutually-beneficial, bidirectional relationship between the academic institution and the community?
• 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/research? Does the plan address methods of building and sustaining community partnerships and community participation?
• Does the investigator provide previous experience/evidence for conducting community engagement activities/projects? Does the research environment enhance the likelihood of success?

Review Criteria Specific to Training Core:

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

Review Criteria Specific to Research Support Core(s):

• Objectives: 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: 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: Is the Quality Assurance Statement for cores providing quantitative analyses adequate?
• Prioritization: Is there a prioritization plan for use of core facilities/services?
• Qualifications: Does the staff have the appropriate experience and level of commitment?

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

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

Renewals

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

Additional Review Considerations Research Projects and Cores

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

Select Agent Research

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

Resource Sharing Plans

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

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. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review), will be discussed and assigned an overall impact/priority score.
• Will receive a written critique.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center and 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:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

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

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

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

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’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, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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

Not Applicable.

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

A final progress report, invention statement, and 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.

Because the SRP Centers are complex, and relevance to Superfund is a requirement for responsiveness, applicants are strongly encouraged to contact NIEHS staff early in the grant preparation process: http://www.niehs.nih.gov/research/supported/srp/about/contact_staff.cfm.

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: GrantsInfo@nih.gov

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: commons@od.nih.gov

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

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

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

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

Leroy Worth, Ph.D.
National Institute of Environmental Health Sciences (NIEHS)
Telephone: (919) 541-0670
Email: worth@niehs.nih.gov

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

Michelle Victalino
National Institute of Environmental Health Sciences (NIEHS)
Telephone: (919) 316-4666
E-mail: victalinom@niehs.nih.gov

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

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