Grantee Research Project Results

Participating Organization(s)	National Institutes of Health (NIH) U.S. Environmental Protection Agency (EPA) NOTE: This is a joint effort of NIH and EPA and includes requirements of both agencies. Applicants are encouraged to contact NIH and EPA with questions about requirements.
Components of Participating Organizations	National Institute of Environmental Health Sciences (NIEHS) National Center for Environmental Research (NCER)
Funding Opportunity Title	Children's Environmental Health and Disease Prevention Research Centers (P01)
Activity Code	P01 Research Program Projects
Announcement Type	Reissue of RFA-ES-08-002
Related Notices	May 14, 2012 - See Notice NOT-ES-12-011. The purpose of this notice is to inform the extramural research community that a technical assistance webinar will be conducted.
Funding Opportunity Announcement (FOA) Number	RFA-ES-12-001
Companion FOA	None
Number of Applications	Applicant organizations may submit more than one application provided that each application is scientifically distinct. Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.113, 66.509
FOA Purpose	This Funding Opportunity Announcement (FOA) issued by NIEHS and EPA encourages grant applications to support a transdisciplinary program of basic and applied research to examine the effects of environmental factors on children’s health and well-being. Research conducted through the Centers should include substantive areas of science in children’s health while incorporating innovative technologies and approaches and links to the environment. The revised program encourages strong links between disciplines in the basic, applied, clinical and public health sciences to prevent disease and promote health in all children.

Posted Date	April 5, 2012
Letter of Intent Due Date	June 17, 2012
Application Due Date(s)	July 17, 2012
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	November 2012
Advisory Council Review	January 2013
Earliest Start Date(s)	April 2013
Expiration Date	July 18, 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

NIEHS and EPA created the jointly funded Centers for Children's Environmental Health and Disease Prevention Research Program (Children's Centers) in 1998. The guiding principle for this program is to ensure the healthy growth and development of children by protecting them from potential environmental threats and promoting their well-being in the communities where they live, learn and play. The program includes community-based projects, that incorporate both applied and basic science research approaches, and are facilitated by community outreach and translation components. These Children's Centers use multidisciplinary approaches to look at the consequences of early life (pregnancy and early childhood) exposures to environmental chemicals on the health of children and adolescents through a variety of transdisciplinary research programs.

By combining research and outreach, the Children's Centers provide the foundation for a broad base of research on children’s environmental health. They have developed a national network of researchers, health care professionals and advocacy and parents groups to address a range of health outcomes that may result from environmental exposures and unhealthy environments. These could include impairments in overall growth, developmental challenges from adverse birth outcomes which may result in increased risk of chronic diseases later in life (e.g., childhood cancer and metabolic disorders), impairments in nervous system development which may lead to behavioral and learning deficits, altered structure and function of the respiratory system, associated immune responses, and endocrine disruption that may result in systemic disorders.

To protect the environmental health and well-being of children in a sustainable manner, a holistic approach to a child’s environment needs to be considered. This includes factors that may impact a child’s health and well-being including: a child’s developmental stage, physiology, and activities and behaviors; and environmental, economic, and societal (both family and community) factors (both chemical and non-chemical stressors).

NIEHS and EPA will continue to support and facilitate integrated fundamental, clinical, laboratory, and public health science to: (1) identify the positive and/or negative influences of environmental exposures and changing environments on normal physiological function of organs and systems of the fetus/child during gestation/childhood/adolescence; (2) determine the mechanisms of vulnerability to environmental stressors of the fetus and young child at all stages of early development; and (3) consider children’s health from a holistic perspective where the impact of complex environmental exposures may be exacerbated by non-chemical, social, life-style and economic stressors encountered in community settings. Chemical stressors may be considered as single chemicals, or as mixtures and aggregates as may be found in consumer products used by children and environments frequented by children. Non-chemical stressors include modifying factors such as diet and nutrition, physical activity including time spent in various microenvironments, psychosocial factors, and the design of the built environment (e.g., settings: home, school, play areas) from birth through young adulthood. Non-chemical stressors, social and cultural factors, and settings cannot be considered alone, but they can be included as modifier variables to the primary environmental stressor(s).

NIEHS and the EPA recognize that healthy children are the foundation of sustainable communities. Therefore, in addition to considering the health impacts of children’s environments, the Children’s Centers Program is evolving to incorporate principles of sustainability as articulated in the recent NAS report on Sustainability (available at: http://www.nap.edu/catalog.php?record_id=13152).

Under this FOA, NIEHS and EPA plan to provide additional funds to support an optional fourth research project to encourage partnerships between the applicant organization and institutions that are not highly funded for research and development capacity. NIEHS and EPA encourage partnerships with institutions that have traditionally received less than $35 million/year in federal funding for research and development, including institutions that have unique missions and have historically provided services to health disparity populations including minority, low income and tribal communities. These institutions, including Historically Black Colleges and Universities (HBCUs), Hispanic Serving Institutions (HSIs), Tribal Colleges and Universities (TCUs) and Asian American Native American Pacific Islanders Serving Institutions (AANAPISIs), have demonstrated access to these populations, which have not historically fully participated in children’s environmental health research.

This “additional” funding must stay within the confines of the total award budget allowed per grant described in Section II. EPA and NIEHS strongly encourage applications from and partnerships with faculty at colleges and universities that have received less than $35 million/year in federal funding for research and development as listed in the National Science Foundation's publication "Federal Science and Engineering Support to Universities, Colleges, and Nonprofit Institutions: FY 2007," Table 12, column 2 (NSF 2007), available at http://www.nsf.gov/statistics/nsf12301/pdf/tab12.pdf. Additional information is provided below.

NIEHS and EPA have developed a joint program with multiple opportunities to enhance the research in children’s environmental health to meet each Agency’s mission by filling identified research gaps. This Funding Opportunity Announcement (FOA) is designed to encourage applications from strong transdisciplinary research teams proposing an integrated multi-project approach and a well-developed program of cutting-edge research.

The objectives are to (1) capitalize on the research findings and resources from epidemiological and clinical studies of prospective parents, pregnant women and children; (2) enhance the application of novel findings and approaches in areas of basic or mechanistic research e.g., imaging, epigenetics and comparative biology to developmental human studies; (3) develop and apply new or improved biomarkers, environmental measurements (indoors and outdoors), and exposure factors and models to best characterize exposure, potential health effects at various lifestages, and predict longer-term clinical consequences; (4) train new investigators to address emerging issues in children’s environmental health with state of the art tools and methodologies; and (5) ensure active participation of identified stakeholders and the broader community in the research process and translation and application of research findings.

Outputs (results) expected from the research funded under this FOA may include:

• Original peer-reviewed articles and synthesis reports, some of which could inform children’s health decision makers (parents, medical care providers, local governance, policy makers)
• Analysis of complex biological, environmental and social datasets in order to provide insight into the interaction of these domains and their influence on disease occurrence or prevention, success of mitigation strategies, and public health interventions.
• The development and application of multimedia measurements, databases, exposure factors, models, and biomarkers of exposure, susceptibility, and/or effects for use in interpreting children’s health risks and prevention strategies.
• The development and application of novel, low subject burden tools and methods to determine exposure risk from multiple sources and routes, and/or better predict and prevent health outcomes with greater specificity.

Expected outcomes (potential benefits) of the proposed research include:

• The use of both (1) developed tools and methods for more rigorous analyses of children’s health risks and (2) the use of basic science and/or population-based research findings to inform decision-making to reduce or eliminate potentially harmful environmental exposures to children and promote children’s health in community settings.
• Increasing the number of experts trained in cross-disciplinary fields in children’s environmental health based on the latest scientific discoveries.
• Active engagement of a community and other stakeholders in basic and/or population-based research.
• Translation and sharing of research findings with health care professionals and other care providers to promote and improve children’s health.

Research Approaches

The types of research approaches that are encouraged under this FOA include but are not limited to the following:

• Testing new research hypotheses probing environmental linkages to childhood diseases and disorders using existing human studies, registries, environmental samples (both stored and newly collected) and biospecimens. The request to establish a new cohort of pregnant mothers or children is discouraged unless compelling supportive evidence warrants the need. Note: To receive EPA funding any new cohort will have to comply with the requirements identified in section IV.
• The integration of multiple study populations or consortia to pool common data elements or to conduct comparable analyses to improve the ability to test the effect(s) of environmental exposures on diseases, and/or improve understanding of the complex interplay between gene variants and multiple exposures at multiple dose levels for complex disease risk.
• Basic mechanistic laboratory studies utilizing in vitro, in vivo, and/or in silico models of molecular, cellular, tissue and organism responses to developmental perturbation by environmental agents, as one project component, if justified in order to test hypotheses about the environment-disease linkage under study in the overall project.
• Exposure sciences and development and evaluation of targeted prevention and intervention efforts.
• Translation from animal models to clinical investigation.
• Systems approaches to obtain, integrate and analyze complex data arising from multiple sources using interdisciplinary tools.
• - Use of predictive models to test new research hypotheses using available data and comparing the estimates to available data.
• Enhanced involvement of impacted communities in the research process. Community-Based Participatory Research (CBPR) methods/approaches are encouraged. This is a process of scientific inquiry such that community members, persons affected by the health condition, disability or issue under study, or other key stakeholders in the community have the opportunity to be full participants in each phase of the work (from conception to design, implementation, analysis, interpretation, conclusions, and communication of results). CBPR is characterized by substantial community input in the development of the project.
• Research that could lead to better understanding of environmental health issues of children living in rural communities.
• Interdisciplinary approaches to children’s health including the influence of social factors and the design of the built environment.

Applicants must study an environmental agent/chemical/stressor to which there is human exposure and the potential for an in utero exposure. This includes any endocrine active chemical(s) or organic solvents, particulate matter (PM), pesticides, phytochemicals or metals. Non-chemical stressors (e.g., nutrition), social, and cultural factors cannot be considered alone, but applicants are encouraged to include them as secondary or modifier variables to the primary environmental stressor. The Children’s Centers are required to translate and apply their research findings into information for the affected communities, general public, policy-makers and health care professionals with the ultimate goal of protecting children."

Research Topics of interest that applications may focus on under this FOA include, but are not limited to, those listed below. In all cases applicants should show how the application will significantly advance the field rather than confirm or refine earlier findings or models.

• The effects of in utero and/or perinatal exposures to environmental agents (chemical and/or biological) and the role they play by lifestage in biological changes associated with adverse childhood health outcomes.
• Use of emerging technologies or approaches to improve exposure and dose estimates to reduce exposures and improve children’s health in community settings, incorporating more direct measures and modeling of exposure and their correlation with biological processes and child health outcomes.
• Identification and characterization of mechanisms and pathways of exposure, including exposure factors (such as soil and dust ingestion) and factors that may increase vulnerability or protection to the fetus or child exposed to specific environmental agents.
• Assess the impact of perinatal exposures on the composition and/or function of the microbiome and how this contributes to childhood disease.
• Characterization of environmental exposures (chemical and biologic), and related outcomes, in settings of greatest importance for children’s exposures (such as homes, child care centers, schools, playgrounds and/or workplaces) and development of strategies to reduce or prevent adverse exposures in those settings. (For consistency, applicants are encouraged to use the lifestage/age grouping guidance from the EPA Risk Assessment Forum, available at https://www.epa.gov/raf/publications/pdfs/AGEGROUPS.PDF.)
• Identification of childhood age groups/lifestages that might be particularly susceptible to certain environmental health concerns such as those related to dietary intake, air, soil/dust, food, water, and land use.
• Development of appropriate biomarkers predictive of alteration in development to design and evaluate targeted prevention and intervention efforts and to be used to test hypotheses of early environmental exposures influence on development of disease or disorders.
• Identification of potential mechanisms (including genetic and epigenetic) that may influence susceptibility to environmental exposures and contribute to disease onset or course in children, and the role of epigenetics in gene-environment interaction.
• Development of studies that focus on diseases or disorders where an environmental exposure is suspected but less well established such as autoimmune disorders, childhood cancers, adverse birth outcomes, neuropsychiatric and neurological disorders.
• Improved understanding of interactions between environmental chemicals and psychosocial or socioeconomic factors that may increase the vulnerability of children and/or adolescents with the goal of reducing and preventing health disparities.
• Evaluation of environmental health concerns for children in population groups not well represented in the published scientific literature such as Asian and Pacific Islander and Native American children, as well as children living in rural areas.

Each Children's Center will propose an overall scientific research theme and plan related to the role of the environment (defined broadly) in the etiology and prevention of children’s adverse health outcomes that is responsive to the objectives of the NIEHS and EPA Children’s Centers Program and responsive to the mission of each Agency.

The application must contain a minimum of three (3) unique but integrated research projects related to the Center’s theme and three (3) essential elements:

• Community Engagement (CE) including a Community Outreach and Translation Core (COTC).
• Engagement of at least one health specialist directly relevant to the Center’s theme (e.g., Pediatric Health Specialists, Obestestrics, Psychologist, Allergist, and or Birth Defects expert).
• Career development of new, junior faculty-level investigators in the field of environmental health science.

Each Children's Center must also include an Administrative Core to provide oversight, coordination and integration of Center activities as well as a Community Outreach and Translation Core (COTC).

Each Children's Center is expected to include a data sharing plan to facilitate data sharing with other Children's Centers, federal researchers, the public, and other key stakeholders.

Applications not containing at least three projects, the three essential elements referenced above, an Administrative Core will be considered non-responsive and will not be reviewed.

A. Applicants must propose an overall research theme and plan that are responsive to the objectives of the NIEHS and EPA Children’s Centers Program. The central scientific theme should be related to the role of the environment (defined broadly) in the etiology and prevention of adverse health outcomes in children. The application must contain three (3) essential elements (outlined below), a minimum of three (3) research projects, an Administrative Core. In addition, a data sharing planis expected to be included. A fourth research project is optional (see the following sub-section for details).

Each application will require three unique but integrated research projects (equivalent to an R01) related to the Center’s theme with an option for a fourth project described below.

Fourth Research Project (optional)

Applicants may propose an optional fourth research project in children’s environmental health designed to provide an opportunity to expand the research capabilities of institutions that are traditionally not highly funded for research and development capacity and for institutions that have unique missions and have historically provided services to health disparity populations including minority, low income and tribal communities. To be eligible for this optional project, applicants are strongly encouraged to partner with institutions receiving less than $35 million/year in federal funding for research and development as listed in the National Science Foundation's publication "Federal Science and Engineering Support to Universities, Colleges, and Nonprofit Institutions: FY 2007," Table 12, column 2 at http://www.nsf.gov/statistics/nsf12301/pdf/tab12.pdf. More information on potentially eligible institutions can be found at EPA’s web site https://www.epa.gov/osbp/mai_program.htm. Ideally this project would enhance the research capabilities of those colleges and universities receiving less than $35 million/year in federal research and development funding as listed in the NSF 2007 publication; train new investigators in emerging issues in children’s environmental health with state of the art tools and methodologies; and provide career development opportunities. A successful application will demonstrate meaningful and active participation, as well as a collaborative research process involving both institutions. Applicants should demonstrate how the proposed research in this project will be integrated with the other three research projects and identify how the project will significantly advance the field in protecting children’s environmental health.

B. To accomplish the research objectives of the program, each Children's Center will be required to incorporate three (3) essential elements into the proposed program. The essential elements are:

(1) Community engagement (CE) including a Community Outreach and Translation Core (COTC). Each Center must demonstrate meaningful and active participation of relevant stakeholders that may have concerns about children’s environmental health and/or environmental exposures under investigation and must include a COTC. The COTC would develop, implement and evaluate strategies to translate and apply the scientific findings of the Center into information for use by the public, policy- makers, and clinical professionals to protect children’s health. The COTC may include a variety of mechanisms for community engagement for one or more of the projects. Examples include (1) a Community-Based Participatory Research (CBPR) plan demonstrating the collaborative process of research involving both researchers and community representatives. The CPBR plan would include consultation with key stakeholder groups in order to consider their views in the design of research projects and to enhance the translation of findings to these key audiences; and/or (2) community advisory boards.

(2) Engagement of at least one Health Specialist directly relevant to the Center’s theme (e.g., pediatric health specialist, clinical expert in the disease area under investigation) This individual must be an active researcher who is qualified to assist with coordination and integration of the scientific projects and who will help ensure that the science under investigation will translate to clinical practice and/or have a positive impact on public health. This person may come from any discipline that traditionally has direct contact with young children in a treatment-based environment, however, the expertise should be suited to the Center’s scientific theme. This individual should be distinct from the Center Program Director. This function can be supported as part of the Administrative Core at no less than 10% effort. The Health Specialist may serve as a project leader/co-leader/co-investigator with additional percent effort.

(3) Career Development. In order to foster the next generation of creative new scientists in children’s environmental health, Center Program Directors are required to support the research career development of new, junior faculty-level investigators within the structure of the Children’s Center. We encourage applicants to consider inclusion of an early stage investigator (including investigators from institutions that have not received federal funding for research and development in excess of $35 million/year as listed in the NSF 2007 publication above) as part of the Center’s career development plan. One individual should be designated for Faculty Development in the application. This person will be expected to devote a minimum of 3 person-months o the award and have a long-term commitment to research in the environmental health sciences. The Faculty Development Investigator (FDI) may hold either a health professional doctorate (M.D., D.O, Pharm. D., doctoral degree in nursing, or other equivalent degree) or a research doctoral degree (Ph.D., or equivalent), should have fewer than eight years of postdoctoral experience (excluding clinical training years) at the time the application is submitted, and should have demonstrated outstanding abilities in basic, clinical or population based research. Designated Faculty Development Investigators must meet the NIH definition of New Investigator, http://grants.nih.gov/grants/new_investigators/resources.htm#definition. The Program Directormust include a description of the career development proposed to be undertaken by the Faculty Development Investigator and provide a letter of recommendation for the designee. A letter from the FDI candidate outlining his/her career goals should also be included in the application. The Faculty Development plan should be included as part of the Administrative Core If the candidate is unknown at time of submission, a general plan to recruit the FDI is required.

C: CORE(S):

1. Administrative CORE (required): Each Center must include an Administrative Core unit to provide oversight, coordination, and integration of Center activities. Individuals in senior leadership positions should provide intellectual, administrative, and scientific leadership for the Center and are critical to its overall effectiveness and evolution. These individuals should be in place and committed to a defined percent effort. Unless otherwise performed by the COTC, the Administrative Core should coordinate community engagement and facilitate meaningful exchange between Center investigators, the community, and stakeholders.

An External Advisory Committee (EAC) to the Center Director should be established and managed as part of the Administrative Core. The function of the EAC is to assist in evaluating the merit, value and ongoing progress of each research project and the relevance and importance of individual organizational elements to accomplish the overall goals of the Center. This group should consist of three to five members having expertise appropriate for the Center's research focus, plus one representative from a community group. Representation from a state or local health department is also encouraged. At least two-thirds (67 percent) of the Committee members should be from outside the grantee institution. The EAC is required to meet at least once annually and NIEHS and EPA staff should be notified of the meeting and invited to attend. A brief report describing the recommendations of the EAC should be provided as part of the annual progress report. Names of potential EAC members should not be solicited or submitted in the application. Please only submit a description of proposed protocols and planned committee by representation and area of expertise. If awarded, you will be asked to provide an identifiable list of membership to the EAC for review by the funding agencies.

2. Community Outreach and Translation Core (COTC) (required): The purpose of this Core is to develop, demonstrate and evaluate strategies to translate and apply the scientific findings of the Center into information for the public, policymakers, and clinical professionals to use to protect the health of children. This must include personnel from one or more of the following areas: health educators, nurses, members of community or faith-based organizations, members of organizations which advocate for research and services pertaining to children's health, members of professional societies of health care professionals, and state and local health departments or medical service organizations. Examples of activities considered responsive are the creation of training materials for health professions, development of novel strategies for dissemination of research findings to the broad audience of stakeholders, and assessment of community understanding of research results and plans for action. Community-Based Participatory Research (CBPR) methods/approaches are encouraged. This is a process of scientific inquiry such that community members, persons affected by the health condition, disability or issue under study, or other key stakeholders in the community have the opportunity to be full participants in each phase of the work (from conception to design, implementation, analysis, interpretation, conclusions, and communication of results). CBPR is characterized by substantial community input in the development of the project.

NIEHS has created a database management system to archive and disseminate outreach materials developed within an environmental research portfolio. There is an expectation that the COTCs will use this repository for the Center management of materials development with the intention for broader outreach to the environmental health research community, stake holders and public. NIEHS will facilitate gaining access to this database and NIEHS will be responsible to manage and maintain the repository and to facilitate outreach efforts.

3. Other CORES (as needed): Each Center is encouraged to make use of existing Core services and resources available through their institution. New Cores should be proposed in the application only if they are not available through existing services or facilities. Each new Core proposed must serve at least two research projects and provide a technique, service, or instrumentation that will enhance ongoing research efforts. Examples include animal resources, cell/tissue culture, pathology, public and environmental health, biostatistics, molecular biology, neuropsychology, neuroimaging, analytical chemistry, exposure assessment, genotyping, and re-sequencing.

The specific Strategic Goal and Objective from the EPA’s Strategic Plan that relate to this FOA are: Goal 3: Cleaning Up Communities and Advancing Sustainable Development, Objective 3.1: Promote Sustainable and Livable Communities. The EPA’s FY 2011-2015 Strategic Plan can be found at: https://www.epa.gov/planandbudget/strategicplan.html. The NIEHS strategic plan can be found at http://www.niehs.nih.gov/about/od/strategicplan/strategicplan2006/index.cfm. NIH grants policies as described in the NIH Grants Policy Statement and the Grants Compliance and Oversight section will apply to the applications submitted and awards made in response to this FOA. Recipients of NIH and EPA grant funds must comply with all applicable Federal statutes (such as those included in appropriations acts) regulations, and policies. Additionally, they must also comply with their institutional requirements.

To be eligible for EPA funding consideration, a project’s focus is to consist of activities within the statutory terms of EPA’s financial assistance authorities; specifically, the statute(s) listed below (see section VIII). Generally, a project must address the causes, effects, extent, prevention, reduction, and elimination of air pollution, water pollution, solid/hazardous waste pollution, toxic substances control, or pesticide control depending on which statute(s) is listed above. These activities should relate to the gathering or transferring of information or advancing the state of knowledge. Applications should emphasize this “learning” concept, as opposed to “fixing” an environmental problem via a well-established method. Applications relating to other topics which are sometimes included within the term “environment” such as recreation, conservation, restoration, protection of wildlife habitats, etc., must describe the relationship of these topics to the statutorily required purpose of pollution prevention and/or control.

EPA has specific application guidance for research that involves human subjects. Please see the last paragraph of this section for further information pertaining to the need of this guidance, and Section IV, “EPA Human Subjects Research Statement (HSRS)” of this FOA for specific instructions.

Agency policy and ethical considerations prevent EPA technical staff and managers from providing applicants with information that may create an unfair competitive advantage. Consequently, EPA employees will not review, comment, advise, and/or provide technical assistance to applicants preparing applications in response to EPA FOAs. EPA employees cannot endorse any particular application.

Multiple Investigator applications may be submitted. If you choose to submit a Multiple Program Director(s)/Principal Investigator(s) application, you must follow the specific instructions provided in Sections IV. and V. of this FOA. For further information, please see the EPA Implementation Plan for Policy on Multiple Program Director(s)/Principal Investigator(s) (http://rbm.nih.gov/toolkit.htm).

These awards may involve the collection of “Geospatial Information,” which includes information that identifies the geographic location and characteristics of natural or constructed features or boundaries on the Earth or applications, tools, and hardware associated with the generation, maintenance, or distribution of such information. This information may be derived from, among other things, a Geographic Positioning System (GPS), remote sensing, mapping, charting, and surveying technologies, or statistical data.

For human subjects research applications, there are many scientific and ethical considerations that must be addressed by the study sponsor and research team, including, but not limited to, those related to recruitment, retention, participant compensation, third-party issues, researcher-participant interactions, researcher-community interactions, communications, interventions, and education. All such research must comply with the requirements of the Common Rule (40 CFR Part 26), and any human observational exposure studies must also adhere to the principles set forth in the Scientific and Ethical Approaches for Observational Exposure Studies (SEAOES) (EPA/600/R-08/062) (https://www.epa.gov/nerl/sots/SEAOES_doc20080707.pdf) document. SEAOES, which was published by researchers in EPA and which discusses the principles for the ethical conduct of human research studies, serves as a resource for applicants interested in applying under this FOA. References to “SEAOES Principles” in this FOArefers, in general, to the issues of interest in conducting human subjects research studies that maintain the highest scientific and ethical standards and safety during the conduct of these studies. All applications must include a Human Subjects Research Statement (HSRS; described in Section IV) and if the project involves human subjects research, it will be subject to an additional level of review prior to funding decisions being made as described in Section V of this FOA.

Funding Instrument	Grant
Application Types Allowed	New Renewal The OER Glossary and the PHS398 Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	NIEHS and EPA intend to fund an estimate of 7 awards, corresponding to a total of approximately $12 million per year combined from both agencies, including direct and Facilities and Administrative (F&A) costs, annually for 5 years beginning in fiscal year 2013. Future year amounts will depend on annual appropriations. EPA and NIEHS plan to concurrently fund Centers with funding shared by EPA and NIEHS and managed by both EPA and NIEHS. If a Center is concurrently funded, the Center will be supported by two awards: one which provides the EPA portion of the budget, and a companion award which provides the NIEHS portion of the budget. There may be an opportunity for a Center to be funded by only one agency related to mission priorities or program needs, in which case the Center will receive one award by the funding agency. In appropriate circumstances, EPA and NIEHS reserve the right to partially fund applications by funding discrete portions or phases of proposed projects. If EPA and NIEHS decide to partially fund a application, they will do so in a manner that does not prejudice any applicants or affect the basis upon which the application, or portion thereof, was evaluated and selected for award, and therefore maintains the integrity of the competition and selection process. Both NIEHS and EPA reserve the right to reject all applications and make no awards, or make fewer awards than anticipated, or to make additional awards consistent with the policies of the Agencies, if additional funding becomes available after the original selections are made. Any additional selections for awards will be made no later than six months after the original selection decisions.
Award Budget	For each Center, application budgets are limited to $1 million per year direct costs for up to 5 years or up to $1.2 million per year direct costs for up to five years if the optional Project 4 is included. Budgets need to reflect actual needs of the proposed projects. Funding in subsequent years is contingent upon satisfactory progress during the preceding year and availability of funds.
Award Project Period	The total project period for an application submitted in response to this funding opportunity may not exceed 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.

NIH grants policies as described in the NIH Grants Policy Statement and the Grants Compliance and Oversight (http://grants.nih.gov/grants/compliance/compliance.htm) section 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

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Note: Nonprofit organizations described in Section 501(c) (4) of the Internal Revenue Code that lobby are not eligible to apply for EPA funding. Profit-making firms are also not eligible to receive grants from EPA under this program.

National laboratories funded by Federal Agencies (Federally-Funded Research and Development Centers, “FFRDCs”) may not apply. FFRDC employees may cooperate or collaborate with eligible applicants within the limits imposed by applicable legislation and regulations. They may participate in planning, conducting, and analyzing the research directed by the applicant, but may not direct projects on behalf of the applicant organization. The institution, organization, or governance receiving the award may provide funds through its assistance agreement from the EPA to an FFRDC for research personnel, supplies, equipment, and other expenses directly related to the research. However, salaries for permanent FFRDC employees may not be provided through this mechanism.

Federal Agencies may not apply. Federal employees are not eligible to serve in a principal leadership role on an assistance agreement, and may not receive salaries or augment their Agency’s appropriations in other ways through awards made under this program.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

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(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 least4-6 weeks prior to the application due date.

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

For institutions/organizations proposing multiple PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS398 Application Guide.

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

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

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 will not be accepted.

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:

Linda Bass, Ph.D.
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
MSC K3-03
530 Davis Drive
Durham, NC, 27713
Telephone: (919) 541-1307
FAX: (919) 541-2503
Email: bass@niehs.nih.gov

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:

Linda Bass, Ph.D.
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
MSC K3-03
530 Davis Drive
Durham, NC, 27713
Telephone: (919) 541-1307
FAX: (919) 541-2503
Email: bass@niehs.nih.gov

All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed, with the following requirements:

Overview of the Program Project: 12 pages

Research Project Descriptions:

Research Project Cover Page: 1 page

Research Project Summary: 1 page

Research Project Specific Aims: 1 page

Research Strategy: 12 pages

Core Descriptions:

Core Unit Cover Page: 1 page

Core Unit Summary: 1 page

Core Unit Specific Aims: 1 page

Core Unit Structure, Administration & Services: 6 pages

Description

Follow instructions in the PHS 398 Application Guide, and note the following additional instructions.

The program project grant application should be structured as a series of separate but interrelated projects . State the proposed program’s broad, long-term objectives, specific aims, and the significance to the mission of NIEHS. Define the relevance of each proposed project and shared resource core to the overall theme and goals of the program.

Detailed Budget for Initial Budget Period

Follow instructions in the PHS 398 Application Guide, and note the following additional instructions.

Use PHS-398 Form Page, "DETAILED BUDGET FOR INITIAL BUDGET PERIOD," to present the total budget for all requested support for the first year. For each category, such as "Personnel," "Equipment," etc., give the amount requested for each Research Project component and each Core unit, with subtotals.

If consortium arrangements involving other institutions or organizations are anticipated, include total (direct and indirect) costs associated with such third-party participation in the Consortium/Contractual Costs category. Costs for purchased services should be itemized under the "Other Expenses" category.

Budget for Entire Proposed Period of Support

Follow instructions in the PHS 398 Application Guide, and note the following additional instructions.

Use PHS-398 Form Page, "BUDGET FOR ENTIRE PROPOSED PROJECT PERIOD," to prepare a budget, by category, that provides totals for each year of requested support. Requests for any increases in succeeding years must be justified in the individual Research Project component and Core unit budgets.

Budgets for Individual Research Project Components and Core Components

Prepare “Detailed Budget for Initial Budget Period” for each component

Prepare “Budget for Entire Proposed Period of Support” for each component

Budget Justifications and Explanations

Describe the specific functions of all key personnel, consultants, collaborators, and support staff. For all years, explain and justify any unusual items such as major equipment or alterations and renovations.

Biographical Sketch

Follow instructions in the PHS 398 Application Guide, and note the following additional instructions.

Biographical sketches are required for all key personnel participating in the Research Project components and Core units. Compile all biographical sketches starting with the overall program project leader followed by all other investigators, including the individual project/ core leaders, in alphabetical order. Do not repeat biographical sketches in the individual research projects or shared resources cores.

Resources

Follow instructions in the PHS 398 Application Guide, and note the following additional instructions.

Complete the "Resources" page of PHS-398 for the overall project. Briefly describe the features of the institutional environment that are or would be relevant to the effective implementation of the proposed program. As appropriate, describe available resources, such as clinical and laboratory facilities, participating and affiliated units, patient populations, geographical distribution of space and personnel, and consultative resources.

Project Overview

Each P01 program project application must include a minimum of three individual (albeit connected) research projects each of which is pertinent to the central goal of the program. If support of core resources is requested, a separate component describing and justifying these should be included.

Research Projects

The Research Projects should include:

Cover page.
Project Summary
Project Specific Aims
An overall research strategy section for the project
Any justification for human and animal experimentation.

Each individual project of a program project grant should represent both a separate and an interdependent research effort. Each research project should be prepared according to the application guide instructions. The overall format and page limits for an R01 application apply to each of the component projects. The special benefits associated with being part of the program project must also be addressed. Do not repeat the individual budget pages and biosketches.

Instead of the standard PHS 398 face page for each project, create a cover page for the project that lists the project name and the name of the project director.

Specific Aims

Specific aims should be built around serving the goals of the program project.

Research Strategy

Approach. The special benefits associated with being part of the program project and the relationship of this project to the other projects and cores should be addressed.

Core Descriptions -- Administrative Core

A successful CEHC application will include a well-integrated project plan. Within the Administrative Core, the specific administrative and organizational structure that is needed to support the research and the synergies enabled by the Center needed to be clearly articulated. CEHC projects will be multidisciplinary and interdisciplinary and will draw from a variety of resources. Thus, a well thought out and carefully described organizational structure will be required.

A narrative description should be provided that includes the planning and coordination of research activities; the integration of cross-disciplinary research; the tracking of progress towards Center outputs and outcomes, the oversight of fiscal and resource management; and the maintenance of ongoing communication with NIEHS and EPA. Indicate who will be responsible for each of these activities. Describe the role(s) of advisory groups and consultants.

Describe how the Administrative Core will coordinate the research activities with existing training resources, activities or programs at the institution. No specific funds should be used to develop new training programs or to directly support existing training programs, however, a listing of available training resources should be provided. A plan for tracking the impact of CEHC on investigator training should be described.

Develop and describe a career development plan with the institution

Describe how the Administrative Core will coordinate meetings of CEHC investigators with investigators from other CEHCs including active participation in planning the annual Children's Centers meeting.

The applicant should budget travel funds sufficient for attendance of the Center Director and Project and Core leaders at an annual meeting, a one and one-half day meeting at the NIEHS in