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
Announcement Type	Reissue of RFA-ES-09-012
Related Notices	October 13, 2011 - This RFA has been reissued as RFA-ES-12-003. December 1, 2010 - See Notice NOT-ES-11-002 Notice of Informational Web Seminar.
Funding Opportunity Announcement (FOA) Number	RFA-ES-10-010
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 Domestics 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 29, 2010
Open Date (Earliest Submission Date)	March 15, 2011
Letter of Intent Due Date	March 16, 2011
Application Due Date(s)	April 15, 2011, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	N/A
Scientific Merit Review	October 2011
Advisory Council Review	January 2012
Earliest Start Date(s)	April 2012
Expiration Date	April 16, 2011
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 for conducting science 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 FOA are expected to design a research Center that integrates environmental health sciences with related environmental science and engineering disciplines (geochemical, ecological sciences, etc.). 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. Consequently, SRP-funded research is expected to provide a fundamentally sound science base, 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, identifying critical issues for which fundamental science is needed.
• 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 basic 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 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 Superfund issues.
• Community Engagement: The SRP views Community Engagement (defined as the bidirectional interaction between community stakeholders and the research 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. These hypothesis-driven research projects address science-based questions formulated by the community.
• 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.
• Training: Although not required, a Training Core is considered an asset to multi-project Centers because it involves mentoring the next generation of environmental health and science professionals. The current and future research from these trainees will achieve a longstanding impact on society’s awareness of environmental risks and methods of prevention.

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 over the next five years. 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.

It is believed that environmental factors contribute to the etiology of most human diseases/dysfunctions (e.g., reproductive, immune competence, pulmonary/cardiovascular, cancer, neurodevelopment, neurobehavioral, congenital defects, renal, etc.). Therefore, the SRP seeks to support mechanistic and/or mode of action research that includes laboratory-based 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. 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, but a higher 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 are 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). 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, but 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 basic and applied research on 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 methods and devices that offer precise and low-cost readings to increase spatial density of measurements at a hazardous waste site. This includes bioassays or ecological indicators that assess toxicity to biological systems in sites complicated by multiple contaminant streams or complex environmental media. In addition, innovative tools that allow for real-time, on-site monitoring, are encouraged, including: advanced sensors and probes, biosensors, new imaging modalities, 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, groundwater, etc.) but Centers are also encouraged to consider applications for biomonitoring, in collaboration with biomedical researchers. Similarly, tools developed and used for site assessment may also inform predictive modeling, and these approaches should integrate the resulting environmental data within a contextual framework of how contaminants affect nearby populations - human or wildlife. SRP also encourages researchers to consider the sustainability of monitoring tools taking into account device reuse, waste generation, and utilization of non-toxic components (particularly for in situ devices), etc.

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 non-biomedical research (e.g. engineering, geological, and microbiological sciences) 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 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 green and 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 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 (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 (such as trichloroethylene) and minerals (such as 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 such substances formed in environmental media by physical, chemical or biological (e.g., plants, microorganisms, etc.) 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 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;
• 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. Applicants wishing to focus on these compounds 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.

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. 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.

Center Components

Research Projects (Required):

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.

The SRP Strategic Plan emphasizes the importance of investigator-initiated research translation as a means to achieve SRP impact. Researchers should, therefore, coordinate with the Research Translation Core to identify an appropriate plan to facilitate translation of the research project outcomes to potential end-users.

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. Maximizing relevancy requires that all SRP mandate areas (health effects, risk, detection and remediation) are covered, and the most critical current and emerging needs are addressed. 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.

NOTE (Community Engagement Research Projects): SRP also encourages applicants to include, as part of their Center, a community engagement research project. These hypothesis-driven research projects address science-based questions formulated by the community. Such project would count towards one of the minimum two biomedical or two non-biomedical projects, depending on the theme of the research project. These projects should utilize community-based participatory processes of planning, implementing, and communicating pertinent scientific results from primary research. Please see Community Engagement Core section below for definition of target communities and for a description of Community-Based Participatory Processes. Community engagement research projects will be reviewed as research projects (see Section V. Application Review Information); however, applicants should include a plan for how community engagement activities will be conducted in partnership with the target community. The plan must indicate how the participating community (or community group) will be involved in the design and approach of the activity from the onset through to the conclusion of the activity. Letter(s) of support from the participating community or community group should be included in these applications. As with all research projects, a tentative sequence or timetable for the project should be included. Examples of community engagement research project themes may be found in the Suggested Research Topics document on the following website (http://www.niehs.nih.gov/research/supported/srp/funding/rfa.cfm).

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 bidirectional exchange between Center scientists and the community, etc. Examples of appropriate CEC activities include:

• partnering with tribes in determining exposure pathways relevant to their traditional and cultural practices;
• 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;
• 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. (See Section III.3 for budget details).

Community-Based Participatory Processes: Community Engagement Cores, as well as community engagement research projects, should employ community-based participatory processes of planning, implementing, and communicating pertinent results. Hence, the following information should be included with the application:

• Clearly define the community of interest or community partner, community's and academic partners' roles, and topics that are of interest/priority to the community.
• Indicate how the activity/research will lead to improved public understanding of research and long-term, bidirectional relationships between the academic institution and the community for the benefit of both.
• Demonstrate the community's acceptance of the role as a partner in the core/project and that the community's engagement is an integral part of the activity/research (e.g., involvement in planning, organization, and design of activity/research; letters of support from the community).
• Include a management plan for maintaining transparent communications between the community and the academic partners throughout the entire process. Plan should address methods of building and sustaining community partnerships and community participation.
• Provide previous experience/evidence for conducting community engagement activities/projects.
• Identify the activity/research environment and how it will enhance the likelihood of successful completion of the activity/project.

NOTE: All Community Engagement Core activities (and, if applicable, community engagement research project activities) should be coordinated with the appropriate offices in EPA, ATSDR, state, local, or Tribal agencies. This coordination should not compromise the independence of the engagement efforts since the community may value the support of a non-regulatory agency. All activities will follow effective and sensitive engagement protocols especially as they pertain to communities affected by Superfund sites. This includes recognition of and sensitivity towards specific cultural identities and characteristics (e.g., language and beliefs; challenges in discussing health effects; or non-English speaking stakeholders). A plan should be included for coordination with the Center's Research Translation Core for interaction with government agencies and for communicating to other SRP Centers the lessons learned from Center Community Engagement Cores (and, if applicable, from community engagement research projects).

Research Translation Core (Required):

NIEHS 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 leaders in translating research outcomes to appropriate audiences, thereby encouraging the accurate and timely use of these research products.

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. US EPA and ATSDR are directly involved in the National Superfund efforts; 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. In addition, the Community Engagement activities may require liaison with government agencies; therefore, RTC plans should indicate lines of communication with CEC, as applicable.

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, etc.) 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, etc.) 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, other academic researchers, etc. To reach these stakeholders, a variety of mechanisms would be appropriate activities for the RTC including:

• sponsorship of 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.

Administrative Core (Required):

Through the required Administrative Core, the Principal Investigator 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 Principal Investigator 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 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, a direct line of communication between the Administrative Core and the Research Translation Core should be delineated, as both cores serve a critical role for Center integration.

To aid the Principal Investigator in achieving the goals set forth for his or her Center, the establishment of an External Advisory Committee is required to provide guidance to the Principal Investigator 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 including representatives from the USEPA, ATSDR, industry, and/or community organizations, as examples.

Research Support Cores (Required):

The SRP requires that a Center has at least one Research Support Core. The intent is that this Core will provide essential, centralized services or resources that will result in an economy of effort and/or savings in the overall costs of a Center. Well designed cores also serve as a useful tool in promoting interdisciplinary activities. By definition, 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 IV.6.B. for additional requirements.)

Training Core (Optional):

SRP strongly encourages applicants to include a Training Core, which supports graduate and postdoctoral level cross-disciplinary training in fields related to environmental health and environmental science/engineering. The Training Core needs to reflect the interdisciplinary nature of the overall research effort of the Center enhancing cross training of trainees in disciplines not traditionally linked in 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. In addition to providing students with unique opportunities in interdisciplinary research, the SRP also encourages the Training Cores to facilitate practical opportunities for coordination or collaboration among other grantees and for communicating research outcomes to diverse audiences. For example, all researchers need to know 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. SRP also encourages the Training Core to formally support trainee participation in the Community Engagement and Research Translation Cores. Opportunities such as this will provide students with valuable insights on the full cycle of the research that they conduct.

NOTE: The training of pre- and post-doctoral students may be carried on outside the structured Training Core. In these cases, the budgets for these students should be part of the project or core budgets rather than the Training Core budget. 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).

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 $10 million in FY 2012 to fund three to four SRP grants in response to this FOA.
Award Budget	A new applicant may request a budget for direct costs of up to $1.8 million dollars for the first year. Applicants submitting renewal applications may request up to a three percent increase above the awarded direct costs of the last year of their continuation project (non-competitive renewal). For all applicants, budgets submitted in subsequent years may not exceed an escalation of three percent on recurring direct costs.
Award Project Period	New applicants may propose a project period of up to four years. Renewal applicants may propose a project period of up to five 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

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.

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

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

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

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 Principal Investigator as the designated leader of the SRP multi-project grant to provide scientific and administrative leadership to the Center. The Principal Investigator 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:

• 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, biomedical engineering, etc.
• 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, etc.
• 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 three percent cost escalations allowed by NIH. Support for appropriate staff positions, consultants, travel and supplies are allowed.
• An approved Administrative Core. The Administrative Core must include an external advisory committee which should provide oversight and advice to the Principal Investigator in accomplishing the Center goals.
• One approved Research Support Core. Research Support Cores must be used by at least two of the research projects.
• 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.

In addition to these required Center components, it is important for the applicant to recognize that the SRP is more than a basic research program and is strongly encouraged to make investments in training through an optional Training Core.

• A Training Core. The direct costs for the Training Core are not to exceed six percent of the total direct costs for the total Center’s budget. 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.

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

The letter of intent should be sent to:

Janice B. Allen, 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
email: Allen9@niehs.nih.gov
office: 919-541-7556
fax: 301-451-5715

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:

Janice B. Allen, 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
email: Allen9@niehs.nih.gov
office: 919-541-7556
fax: 301-451-5715

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

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.

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 and responsiveness by NIEHS, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

The applications submitted in response to this FOA are complex, and the scientific and programmatic information needed to adequately assess a grant proposal 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.

In general an SRP grant proposal will consist of the following categories of information:

Section l. This section consolidates the budget information, the list of all professional and non-professional personnel, biosketches for all key personnel, institutional environment and resources and tables of core utilization and use of human subjects/vertebrate animals for the entire applicant’s Center.

Section ll. This section is unique to the multi-project application. The information requested in this section, for the most part, is not covered in the PHS 398 and includes: an overall Center Introduction describing the major theme, goals and objectives; the multidisciplinary nature of the Center and the interactions between the projects and cores; an indication of project designation as biomedical, non-biomedical, and/or community-engagement; a description of the role of the Principal Investigator; a description of the organizational structure of the applicant’s Center including an administrative and a management plan to achieve an integrated coordinated research Center; and for competing renewals, a general progress report. For resubmission (amended) applications, an additional introduction section is required. The Center Introduction component of Section II is limited to 12 pages.

Section lll- Vlll. These sections contain the research plans for the individual research projects, Research Support Cores, Administrative Core, Research Translation Core, Community Engagement Core and Training Core and follow the guidelines established in the PHS 398. Note: according to the Restructured Research Plan, as indicated in NOT-OD-09-149, the Research Strategy section should consist of significance, innovation, approach and either preliminary studies (new applications) or progress report (for renewal/revision applications), as applicable. The Research Strategy section is limited to 12 pages.

Section lX-Xl. These sections include the Plan for Data Sharing, the Checklist and Appendix materials.

Quality Assurance Statements will be necessary ONLY for Research Support Cores that provide analytical, quantitative services to the applicant’s Center.

EPA regulations as stated in 40CFR30.54 require the inclusion of a Quality Assurance Narrative Statement (QANS, OMB # 2080-0033, approved 8/14/97) for any project application involving data collection or processing, environmental measurements, and/or modeling. The QANS provides information on how quality processes or products will be assured. NIEHS cannot consider applications incomplete without this statement; however, it requests that the QANS be included with all applications that contain analytical and quantitative cores. For awards that involve environmentally related measurements or data generation, a quality system that complies with the requirements of ANSI/ASQC E4, "Specifications and Guidelines for Quality Systems for Environmental Data Collection and Environmental Technology Programs," must be in place. The Quality Assurance Statement should not exceed two pages. This Statement should, for each item listed below, present the required information, reference the specific page and paragraph number of the project description containing the information, or provide a justification as to why the item does not apply to the proposed research.

1. Discuss the activities to be performed or hypothesis to be tested and criteria for determining acceptable data quality. (Note: Such criteria may be expressed in terms of precision, accuracy, representativeness, completeness, and comparability or in terms of data quality objectives or acceptance criteria. Furthermore, these criteria must also be applied to determine the acceptability of existing or secondary data to be used in the project. In this context secondary data may be defined as data collected for other purposes or from other sources, including the literature, compilations from computerized data bases, or results from mathematical models of environmental processes and conditions.)

2. Describe the study design, including sample type and location requirements, all statistical analyses that were or will be used to estimate the types and numbers of samples required for physical samples, or equivalent information for studies using survey and interview techniques.

3. Describe the procedures for the handling and custody of samples, including sample collection, identification, preservation, transportation, and storage.

4. Describe the procedures that will be used in the calibration and performance evaluation of all analytical instrumentation and all methods of analysis to be used during the project. Explain how the effectiveness of any new technology will be measured and how it will be benchmarked to improve an existing process, such as those used by industry.

5. Discuss the procedures for data reduction and reporting, including a description of all statistical methods with reference to any statistical software to be used to make inferences and conclusions. Discuss any computer models to be designed or utilized with associated verification and validation techniques.

6. Describe the quantitative and/or qualitative procedures that will be used to evaluate the success of the project, including any plans for peer or other reviews of the study design or analytical methods prior to data collection.

ANSI/ASQC E4, "Specifications and Guidelines for Quality Systems for Environmental Data Collection and Environmental Technology Programs," is available for purchase from the American Society for Quality, phone 1-800-248-1946, item T55. Only in exceptional circumstances should it be necessary to consult this document.

It is the intent of the NIEHS to hold annual grantee meetings. Funds for travel by appropriate staff (i.e., Principal Investigator, Business Manager, and four students) 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 announcement, note the following:

The initial review for scientific and technical merit will emphasize two major aspects: (1) Overall Impact - Overall; and (2) Overall Impact - Research Projects and Cores.

1) Overall Impact - Overall is the review of the Overall SRP Center application, i.e. the multi-project grant as an integrated research effort of projects and support cores focused on a problem-based, solution-oriented theme. Reviewers will provide an overall impact/priority score in consideration of the five Scored Review Criteria (Significance, Investigator, Innovation, Approach, and Environment) as well as the following additional review criteria: Multidisciplinary and Interdisciplinary Nature of the Center; Review Criteria for Renewal Applications (as applicable).

2) Overall Impact - Research Projects and Cores is the review of each research project, research support core and other core components independently. Reviewers will provide an overall impact/priority score in consideration of the five Scored Review Criteria (Significance, Investigator, Innovation, Approach, and Environment), additional review criteria (Protections for Human Subjects, Vertebrate Animals, Inclusion Plans, and Biohazards) and the Project/Core's Contribution to the Overall SRP Center. There are additional review elements for Community Engagement Cores/Projects and for Renewal Applications. Some cores (Administrative, Research Support, Research Translation, and Training) have additional review criteria specific to that core (described below).

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, 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 Center that by its nature is not innovative may be essential to advance a field.

Significance

Does the overall Center address an important problem or a critical barrier to progress in the field? If the aims of the overall Center 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?

Does the Overall 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 Overall SRP Center provide data, information, and knowledge to inform the risk assessment and remediation management processes for hazardous waste sites? Will the Center provide a rigorous scientific basis for effective decision-making?

Is the importance of the proposed Center sufficient to 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 incremental advance, or would it provide a substantial step forward?

Would the expected achievements of the overall program be possible through mechanisms other than this multi-project Center?

Investigator(s)

Are the PD/PIs, collaborators, and other researchers well suited to the Center? 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)?

Do the experience and scientific leadership of the Center's Overall Principal Investigator allow him/her to effectively direct a large complex multidisciplinary Center?

Does the Center Principal Investigator demonstrate the appropriate ability and experience to coordinate the interactions of the research projects with effective utilization of cores to achieve programmatic goals? Are the level of commitment and ability to develop a well-defined central research focus adequate?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? Does the 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? Are potential problems, alternative strategies, and benchmarks for success presented? If the Center is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the Center 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? Are the research projects and cores well integrated, well reasoned, and appropriate to the overall theme and goals of the proposed Center? Is there strong synergy among the combined efforts of the various investigators within the overall Center?

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 Center proposed? Will the Center benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

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.

Multidisciplinary and Interdisciplinary Nature of the Overall SRP Center:

• Interdisciplinary Nature of Research Activities. Are the projects integrated around a central 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?
• 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? Is there evidence for the translation and delivery of the research findings to appropriate audiences?
• Synergy of the Center. Is there evidence of meaningful interdisciplinary/multidisciplinary collaboration and synergistic potential among the research projects and cores? 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 in scientific disciplines in order to achieve meaningful contributions to protecting human health and the environment?
• 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?
• For competing renewals, is there evidence that there were integration and synergy among the projects and cores within the Center?

Review Criteria for Renewal Applications:

• Is there evidence of progress and achievements specific to this Center since the previous competitive review? Is there documentation through publications, conferences, etc. that demonstrates that collaboration between or among projects has occurred?
• 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?

In addition to the Overall Impact score for the Overall Center, reviewers will provide an overall impact/priority score for each Research Project and Core 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/core proposed).

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

Significance

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

Investigator(s)

Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? Does the project address an innovative hypothesis or critical barrier to progress in the field? Does the project 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 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?

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 Overall SRP Center:

• Does the project/core contribute scientifically to the overall 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, objectives that can be accomplished with greater effectiveness and/or economy of effort, etc.)?

Review Criteria for Renewal Applications:

• For renewals, reviewers will evaluate whether previous specific aims, as funded, have been accomplished and whether the new research goals are logical extensions of ongoing work.

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.

In addition to the review criteria described above for research projects and cores, the following will be considered by the review panel in evaluating specified cores (and community engagement projects).

Review Criteria for 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?

Additional Review Criteria for the Administrative Core:

• 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?
• 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)?
• Qualifications of the senior leaders of the 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?
• Qualifications of the administrative staff. Are the qualifications, duties and time commitments of administrative staff appropriate to contribute to the needs and conduct of the Center’s research activities?
• Adequacy of Center’s resources. Are the resources committed to the Administrative Core adequate?

Additional Review Criteria for the Research Support Cores:

• The Core’s utility to the 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?
• The quality of the facility or service provided. Is the Quality Control and Quality Assurance plan for cores providing quantitative analyses adequate?
• Prioritization. Is there a prioritization plan for core usage?
• The qualification of the personnel involved. Does the staff have the appropriate experience and level of commitment?
• For renewals. Is there evidence that the previous aims, as funded, were accomplished?

Additional Review Criteria for the Research Translation Core:

• Qualifications. Are the qualifications of proposed personnel adequate to conduct the activities described for the core?
• Communication within SRP. Is the proposed plan adequate for identifying research translation opportunities on a project-level as well as a Center-level? 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?
• Partnering. 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?
• Communication with broad audiences. 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?
• Adequacy of Center’s resources. Are the resources committed to the Research Translation Core appropriate for the proposed activities?
• For renewals. Is there evidence that the previous aims, as funded, were accomplished?

Additional Review Criteria for the Training Core:

• Objectives. Are the objectives, design, and direction for the research training appropriate to the Center? Are the approaches and methods proposed adequate to develop training curriculum and courses that provide opportunities to interface with different scientific disciplines? Does the Training Core reflect the interdisciplinary nature of the Center?
• Recruitment and selection. Are plans for the recruitment and selection of individuals appropriate?
• Adequacy of the training environment. Is the institutional commitment adequate? Are the quality of the facilities and the availability of courses appropriate to the SRP? Is there an availability of research support for post-doctoral training?
• For renewals. Is there evidence that the previous aims, as funded, were accomplished?

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.

Revisions

Not Applicable

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

Applications from Foreign Organizations

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.

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 (assignments will be shown in the eRA Commons), in accordance with NIH peer review policy and procedures, using the stated review criteria.

As part of the scientific peer review, all applications will:

• 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.
• 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 Council. The following will be considered in making funding decisions:

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

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

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

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

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

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

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

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NGA. 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 Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.FSRS.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

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

Because of the complexity of the SRP, applicants are strongly encouraged to contact NIEHS staff early in the grant preparation process.

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

William Suk, Ph.D.
Director, Center for Risk and Integrated Sciences
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, K3-04
Research Triangle Park, NC 27709
Telephone: 919-541-0797
FAX: 919-541-4937
Email: suk@niehs.nih.gov

Claudia Thompson, Ph.D.
Center for Risk and Integrated Sciences
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, K3-04
Research Triangle Park, NC 27709
Telephone: 919-541-4638
FAX: 919-541-4937
Email: thomps14@niehs.nih.gov

Heather Henry, Ph.D.
Center for Risk and Integrated Sciences
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, K3-04
Research Triangle Park, NC 27709
Telephone: 919-541-5330
FAX: 919-541-4937
Email: henryh@niehs.nih.gov

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

Janice B. Allen, Ph.D.
Scientific Review Officer
Scientific Review Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, K3-03
Research Triangle Park, NC 27709
Telephone: 919-541-7556
FAX: 301-451-5715
Email: Allen9@niehs.nih.gov

Lisa Archer Edwards, M.B.A.
Grants Management Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
111 T.W. Alexander Drive
P.O. Box 12233, K3-11
Research Triangle Park, North Carolina 27709
Telephone: 919-541-0751
FAX: 301-451-5334
E-mail: archer@niehs.nih.gov

Michelle Victalino
Grants Management Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
111 T.W. Alexander Drive
P.O. Box 12233, K3-11
Research Triangle Park, North Carolina 27709
Telephone: 919-316-4666
FAX: 301-451-5334
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.