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	September 30, 2014 - This RFA has been reissued as RFA-ES-14-002. 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 http://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 http://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: http://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) (http://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: [email protected]

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: [email protected]

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 Research Triangle Park, NC or at the US EPA in Research Triangle Park, NC or Washington DC.

Describe the Children's Health Specialist and their expertise and role in the overall integration of the proposed projects and the support of the overall translation central theme of the Center.

Facility/Service Cores

Describe the function of the core as a resource to the program. This section must clearly present the facilities, techniques, and professional skills that the core will provide. As justification for the core, briefly indicate the specific Research Projects that will use the resources of the core. A Research Support Core is principally designed as a service or resource component; it would be highly unusual to include research in a core (a possible exception would be methodology development). Please contact the NIEHS program staff if you require guidance on this issue.

Describe the role of the core as a resource to the program as a whole. Discuss ways in which these centralized services will produce an economy of effort and/or savings in overall costs compared to their inclusion as part of each project in the program. To aid in the review of your application it is recommended that you prepare in tabular form information concerning the research projects that each facility core unit would serve and the proportion of the cost of the facility core unit associated with each research project involved.

NOTE: An Applicant is not required to include facility cores in their CEHC.

Community Outreach and Translation Core

A successful COTC should describe a plan to collect, integrate and disseminate research findings and Centers activities for the public, policy makers, and clinical professionals to use to protect the health of children.

Describe the membership of the COTC and types of expertise to be recruited to enhance effective communication strategies. Describe the type of innovative methods that may be used to enhance COTC activities including ways of interacting with stakeholders or identified end-users of materials.

Describe plans of how the COTC investigators will be able to access the effectiveness of their developed products and whenever possible.

Describe how the COTC will interact with Center investigators and the Administrative Core to develop materials and assist with the goals of the COTC.

Describe how the COTC will develop, enhance, and ensure a productive working relationship between the community and Children’s Center researchers.

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:

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.

EPA Human Subjects Research Statement (HSRS) (4 pages)

All human research studies conducted or supported by EPA are governed by EPA regulations at 40 CFR Part 26 (Protection of Human Subjects; http://www.gpo.gov/fdsys/pkg/CFR-2010-title40-vol1/xml/CFR-2010-title40-vol1-part26.xml). This includes the Basic Federal Policy for the Protection of Human Research Subjects, also known as the Common Rule, at subpart A and additional prohibitions and special protections for pregnant women, nursing women, and children in research conducted or supported by EPA at subparts B, C, and D. Depending upon the type of research being conducted, additional subparts of 40 CFR 26 may be relevant.

Procedures for the review and oversight of human research subject to 40 CFR Part 26 are also provided in EPA Order 1000.17 Change A1 (http://www.epa.gov/phre/pdf/epa_order_1000-17-a1.pdf). These include review of projects for EPA-supported human research by the EPA Human Subjects Research Review Official (HSRRO). EPA Order 1000.17 Change A1 requires preliminary approval by the HSRRO of all proposed EPA-supported human research before the agreement can be entered into. Additional requirements must be met and final approval received from the HSRRO before the research can begin. When reviewing human observational exposure studies, EPA Order 1000.17 Change A1 requires the HSRRO to apply the principles described in the SEAOES document (http://www.epa.gov/nerl/sots/SEAOES_doc20080707.pdf) and grant approval only to studies that adhere to those principles.

All applications submitted under this solicitation must include a HSRS as described below. Use the definitions below to determine whether the proposed research involves human subjects, and then prepare a HSRS as explained below in the HSRS Requirements section.

Definitions (from 40 CFR 26 Subparts A, B, and C)

• "Human subject" means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.
• "Intervention" includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.
• "Interaction" includes communication or interpersonal contact between investigator and subject.
• "Private information" includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record).
• "Individually identifiable" means the identity of the subject is or may readily be ascertained by the investigator or associated with the information.
• "Research involving the intentional exposure of a human subject" means a study of a substance in which the exposure to the substance experienced by a human subject participating in the study would not have occurred but for the human subject’s participation in the study.
• "Observational research" means any human research that does not meet the definition of research involving intentional exposure of a human subject.

Human Subjects Research Statement (HSRS) Requirements

If the proposed research does not involve human subjects as defined above, provide the following statement in your application package as your HSRS: The proposed research does not involve human subjects. Applicants should provide a clear justification about how the proposed research does not meet the definition (for example, all samples come from deceased individuals OR samples are purchased from a commercial source and provided without identifiers, etc).

If the proposed research involves human subjects, then include in your application package a HSRS that addresses each applicable section listed below, referencing the specific location of the information in the Research Plan, providing the information in the HSRS, or explaining why the section does not apply to the proposed research. (Not all will apply.) Please use the definitions provided above to ensure consistency in the interpretation of terminology. Do not exceed four consecutively numbered, 8.5x11-inch pages of single-spaced, standard 12-point type with 1-inch margins.

NOTE: Before EPA approves any research involving human subjects, the requirements of the regulations at 40 CFR 26 must be met. For further information, see Section VI.C.3. Also, before EPA approves human observational exposure research, EPA will examine it to ensure consistency with the SEAOES Principles. The factors below are not intended to be exhaustive of all those needed for the HSRRO to provide the final approval necessary for research to be conducted, but provide a basis upon which the HSRRO may grant the conditional approval necessary for the funding process to begin.

(1) Human subjects involvement, characteristics, and design.

(a) Describe and justify the proposed involvement of human subjects in the work being proposed.

(b) Describe the characteristics of the subject population, including their anticipated number, page range, and health status if relevant.

(c) Describe and justify the sampling plan, as well as the recruitment and retention strategies and the criteria for inclusion or exclusion of any subpopulations.

(d) Describe the research material that will be obtained from or about living individuals in the form of data, specimens, or records.

(e) List any collaborating sites where human subjects research will be performed, and describe the role of those sites and collaborating investigators in the research.

(f) Describe and justify any compensation being provided to subjects for their participation in the research.

(g) Describe the plan for communicating individual and/or aggregate research results to participants, if relevant.

(2) Potential risks to subjects.

(a) Describe the potential risks to human subjects (physical, psychological, financial, legal, or other) and assess their likelihood and seriousness to the human subjects.

(3) Adequacy of protection against risks.

(a) Describe planned procedures for protecting against or minimizing potential risks and assess their likely effectiveness.

(b) Describe planned procedures for the process of obtaining and maintaining informed consent. Include a description of the circumstances under which consent will be sought and obtained, who will seek it, the nature of the information to be provided to prospective subjects, and the method of documenting consent.

(c) If waiver of some or all of the elements of informed consent or of documentation of consent will be sought, provide justification for the waiver.

(d) Where appropriate, discuss the plans for ensuring necessary medical or professional intervention in the event of adverse effects to subjects.

(4) Protection of vulnerable groups.

(a) Explain the rationale for the involvement of any vulnerable populations, including pregnant women, fetuses, and children if relevant.

(b) Describe the additional protections in place, if any, for protecting vulnerable populations included in the research.

(c) If children are included in the research, describe the process for obtaining parental permission and child assent if relevant.

(5) Protection of privacy and confidentiality.

(a) Describe how data, specimens, and/or records will be collected, managed, and protected, including at collaborating sites, if any, as well as at the primary site.

(b) Indicate who will have access to individually identifiable private information about human subjects.

(c) Describe any additional procedures for the protection of privacy and confidentiality of the human research subjects.

(d) Discuss any mandatory reporting requirements with the potential to come into play during the conduct of the research and describe how these will be communicated to participants if relevant.

(e) Discuss the potential of the research to obtain information about third parties and describe how this will be handled if it occurs.

(6) Relationship between researcher and community.

(a) If the research will take place in a community setting, describe the procedures in place for defining the community, obtaining its involvement in the research, and establishing and maintaining trust.

(7) Potential benefits of the research to the participants and others.

(a) Discuss the potential benefits of the research to the research participants and others.

(b) Discuss why the risks to subjects are reasonable in relation to the anticipated benefits.

(8) Importance of the knowledge to be gained.

(a) Discuss the importance of the knowledge to be gained as a result of the proposed research.

(b) Discuss why the risks to subjects are reasonable in relation to the importance of the knowledge that reasonably may be expected to result.

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.

For EPA awards: Executive Order 12372, Intergovernmental Review of Federal Programs, does not apply to the EPA’s Office of Research and Development's research and training programs unless EPA has determined that the activities that will be carried out under the application (a) require an Environmental Impact Statement (EIS), or (b) do not require an EIS but will be newly initiated at a particular site and require unusual measures to limit the possibility of adverse exposure or hazard to the general public, or (c) have a unique geographic focus and are directly relevant to the governmental responsibilities of a State or local government within that geographic area.

If EPA determines that Executive Order 12372 applies to an application, the applicant must follow the procedures in 40 CFR Part 29. The applicant must notify their state's single point of contact (SPOC). To determine whether their state participates in this process, and how to comply, applicants should consult http://www.whitehouse.gov/omb/grants_spoc/. If an applicant is in a State that does not have a SPOC, or the State has not selected research and development grants for intergovernmental review, the applicant must notify directly affected State, area wide, regional and local entities of its application.

EPA will notify the successful applicant(s) if Executive Order 12372 applies to its application prior to award.

EPA awards are subject to the following funding restrictions:

EPA awards funds to one eligible applicant as the recipient even if other eligible applicants are named as partners or co-applicants or members of a coalition or consortium. The recipient is accountable to EPA for the proper expenditure of funds. IF the grant is funded by both NIEHS and EPA, then the recipient is accountable to EPA and NIEHS for the proper expenditure of funds.

All award decisions are subject to the availability of funds. In accordance with the Federal Grant and Cooperative Agreement Act, 31 U.S.C. 6301 et seq., the primary purpose of an assistance agreement is to accomplish a public purpose of support or stimulation authorized by federal statute, rather than acquisition for the direct benefit or use of the Agency. In issuing a grant, the EPA and NIEHS anticipate that there will be no substantial EPA involvement in the design, implementation, or conduct of the research. However, the EPA and NIEHS will monitor research progress through a variety of means, including annual reports provided by grantees and other contacts, as well as site visits with the Principal Investigator(s).

EPA funding may be used to provide subgrants or subawards of financial assistance, which includes using subawards or subgrants to fund partnerships, provided the recipient complies with applicable requirements for subawards or subgrants including those contained in 40 CFR Parts 30 or 31, as appropriate. Applicants must compete contracts for services and products, including consultant contracts, and conduct cost and price analyses to the extent required by the procurement provisions of the regulations at 40 CFR Parts 30 or 31, as appropriate. The regulations also contain limitations on consultant compensation. Applicants are not required to identify subawardees/subgrantees and/or contractors (including consultants) in their application. However, if they do, the fact that an applicant selected for award has named a specific subawardee/subgrantee, contractor, or consultant in the application EPA selects for funding does not relieve the applicant of its obligations to comply with subaward/subgrant and/or competitive procurement requirements as appropriate. Please note that applicants may not award sole source contracts to consulting, engineering or other firms assisting applicants with the application based solely on the firm's role in preparing the application.

Successful applicants cannot use subgrants or subawards to avoid requirements in EPA grant regulations for competitive procurement by using these instruments to acquire commercial services or products from for-profit organizations to carry out its assistance agreement. The nature of the transaction between the recipient and the subawardee or subgrantee must be consistent with the standards for distinguishing between vendor transactions and subrecipient assistance under Subpart B Section .210 of OMB Circular A-133, and the definitions of subaward at 40 CFR 30.2(ff) or subgrant at 40 CFR 31.3, as applicable. Neither EPA nor NIEHS will be a party to these transactions. Applicants acquiring commercial goods or services must comply with the competitive procurement standards in 40 CFR Part 30 or 40 CFR Part 31.36 and cannot use a subaward/subgrant as the funding mechanism.

Section V of the announcement describes the evaluation criteria and evaluation process that will be used to make selections under this announcement. During this evaluation, except for those criteria that relate to the applicant's own qualifications, past performance, and reporting history, the review panel will consider, if appropriate and relevant, the qualifications, expertise, and experience of:

(i) an applicant's named subawardees/subgrantees identified in the application if the applicant demonstrates in the application that if it receives an award that the subaward/subgrant will be properly awarded consistent with the applicable regulations in 40 CFR Parts 30 or 31. For example, applicants must not use subawards/subgrants to obtain commercial services or products from for profit firms or individual consultants.

(ii) an applicant's named contractor(s), including consultants, identified in the application if the applicant demonstrates in its application that the contractor(s) was selected in compliance with the competitive procurement standards in 40 CFR Part 30 or 40 CFR 31.36 as appropriate. For example, an applicant must demonstrate that it selected the contractor(s) competitively or that a proper non-competitive sole-source award consistent with the regulations will be made to the contractor(s), that efforts were made to provide small and disadvantaged businesses with opportunities to compete, and that some form of cost or price analysis was conducted. EPA may not accept sole source justifications for contracts for services or products that are otherwise readily available in the commercial marketplace.

As part of the budgetary process, EPA will not consider the qualifications, experience, and expertise of named subawardees/subgrantees and/or named contractor(s) during the application evaluation process unless the applicant complies with these requirements.

Each proposed project must be able to be completed within the project period and with the initial award of funds. Applicants should request the entire amount of money needed to complete the project. Recipients should not anticipate additional funding beyond the initial award of funds for a specific project.

Applications must be received on 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 components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

Budget for Submissions to EPA: Please note that when formulating budgets for proposals/applications, applicants must not include management fees or similar charges in excess of the direct costs and indirect costs at the rate approved by the applicants cognizant audit agency, or at the rate provided for by the terms of the agreement negotiated with EPA. The term "management fees or similar charges" refers to expenses added to the direct costs in order to accumulate and reserve funds for ongoing business expenses, unforeseen liabilities, or for other similar costs that are not allowable under EPA assistance agreements. Management fees or similar charges may not be used to improve or expand the project funded under this agreement, except to the extent authorized as a direct cost of carrying out the scope of work.

Confidentiality:

By submitting an application in response to this Funding Opportunity Anncouncement, the applicant grants the EPA permission to make limited disclosures of the application to technical reviewers both within and outside the Agency for the express purpose of assisting the Agency with evaluating the application. Information from a pending or unsuccessful application will be kept confidential to the fullest extent allowed under law; information from a successful application may be publicly disclosed to the extent permitted by law.

EPA recommends that you do not include confidential business information ( CBI ) in your application. However, if confidential business information is included, it will be treated in accordance with 40 CFR 2.203. Applicants must clearly indicate which portion(s) of their proposal/application they are claiming as CBI. EPA will evaluate such claims in accordance with 40 CFR Part 2. If no claim of confidentiality is made, EPA is not required to make the inquiry to the applicant otherwise required by 40 CFR 2.204(c)(2) prior to disclosure. The Agency protects competitive proposals/applications from disclosure under applicable provisions of the Freedom of Information Act prior to the completion of the competitive selection process.

NIEHS and EPA awards:

Each Center must budget $5,000.00 per year to support annual Children's Environmental Health Meetings in venues yet to be determined in collaboration with the Center Investigators, NIEHS and EPA Program Officials. These funds can be used to support costs asociated with logistics of the annual Children's Center meeting, including facilities necessary for hosting meeting and traveling outside speakers. Additionally, Centers will be responsible for the support of traveling key personnel to the annual Children's Center Meetings. All Program Directors will be expected to be an active participant in the planning and implementation of the annual meeting.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115, with the following modifications:

EPA Award Procedures: Applicants to be recommended for EPA funding will be required to submit additional information and an electronic version of the revised project abstract. They may also be asked to provide responses to comments or suggestions offered by the peer reviewers and/or a revised budget. EPA Project Officers will contact the Principal Investigator to obtain these materials. Before or after an award, applicants may be required to provide additional quality assurance documentation.

EPA Quality Assurance Documentation: For any project involving data collection or processing, conducting surveys, environmental measurements, modeling, or the development of environmental technology (whether hardware-based or via new techniques), EPA will require the recipient to submit a Quality Management Plan and other appropriate quality assurance documentation on the processes that will be used to assure that results of the research satisfy the intended project objectives. This is not required for application submission, but will be required for any applications that EPA chooses to recommend for funding. More detailed information on requirements can be found at http://www.epa.gov/ncer/guidance/qa.html.

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.

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project 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 proposed).

Does the Center consist of a cohesive and multidisciplinary focus? Does a coordinated interrelationship exist between the research projects and cores? Are the components of the Center related to the common theme of the Center? What is the scientific gain of combining the component parts into a Center? For new applications, is there evidence of the degree of synergy (degree of interaction, collaborative research opportunities) that will be stimulated by the Center? How do the research projects and cores relate to the central theme and the ability of the Center to meet its long range goals? Will the specific scientific objectives of each project benefit significantly from, or depend upon collaborative interactions with other projects in the program (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)? Have the investigators adequately conceptualized the Center’s expected results and potential benefits to the broader public?

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?

Investigator(s)

Are the PD(s)/PI(s), 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(s)/PI(s), 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?

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?

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 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.

If the Research Project(s) include(s) Community Based Participatory Research as an aspect of the Project, then the following criteria will be included in the evaluation. Are the Center s activities appropriate to the needs of the community involved? Is the research proposed focused on children’s environmental health or the exposure under investigation? Is there a mechanism present for regular communication and coordination among investigators and relevant stakeholders with concerns focused on children’s environmental health or environmental exposures? Are the stakeholders involved in other aspects of the Center? Does a productive working relationship exist between Center investigators and community stakeholders? Will information be adequately disseminated?

Administrative Core

What is the decision-making process within the proposed Center? Is it adequate for the evaluation of research productivity, allocation of funds, and management of the resources? Are procedures clearly outlined to measure and track Center goals, outputs and outcomes?

How will the Administrative Core promote joint planning and evaluation activities as well as collaborations and interactions among different Research Projects of the Centers?

What are the academic environment and resources in which the research will be conducted? Is there available and appropriate space, equipment, human subjects, animals, or other resources as required for potential interaction with scientist(s) from other departments to complete the scope of work as proposed?

What is the institutional commitment to the Center, including fiscal responsibility and management capability of the institution to assist the PD/PI and his/her staff in following DHHS, PHS, NIH and EPA policy?

If the community engagement is discussed as a function of the Administrative Core, then the following criteria must be included in the evaluation. Are the Center s activities appropriate to the needs of the community involved? How will the Center facilitate regular communication and coordination among investigators and relevant stakeholders with concerns focused on children’s environmental health or environmental exposures? How are the stakeholders involved in other aspects of the Center and how they will interact with Center activities and develop a relationship with the Center Investigators? If a Community Advisory Board is proposed, does it have appropriate and adequate membership to be successful?

Facility/Service Cores

What is the Core's utility to Center investigators? Does each Core provide services for two or more research projects that are judged to have substantial merit?

What is the quality of the facility or services provided?

What are the availability and/or adequacy of the physical space, laboratory, clinic and/or equipment proposed for the Core?

What is the cost-effectiveness of the service provided?

Are the qualifications of the personnel involved, their experience, and commitment to the Core appropriate?

Community Outreach and Translation Core

Are the plans for the establishment of a Community Outreach and Translation Core appropriate and adequate for success?

Have particular community groups or organizations been identified and are their support and commitment adequate and appropriate?

Are the detailed plans and approaches for dissemination from the Core adequate for success?

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable.

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.

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

As part of the scientific peer review, all applications:

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

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

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

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

EPA Selection Process Post Review:

EPA's internal review criteria for all applications under consideration for EPA support:

Applications discussed and receiving numerical impact/priorty scores as a result of the NIEHS peer review will undergo an internal programmatic review, as described below, conducted by technical experts from the EPA, including individuals from the Office of Research and Development (ORD) and program and regional offices involved with the science or engineering proposed. All other applications are automatically declined.

After the peer review, those applicants receiving numerical impact/priority scores will be asked to provide additional information for the programmatic review pertaining to the proposed Principal Investigator's (PI) (in the case of Multiple-PI applications, the Contact PI s) "Past Performance and Reporting History." The applicant must provide the EPA Project Officer with information on the proposed Contact PI's past performance and reporting history under prior Federal agency assistance agreements (assistance agreements include grants and cooperative agreements but not contracts) in terms of: (i) the level of success in managing and completing each agreement, and (ii) history of meeting the reporting requirements under each agreement.

This information is required only for the proposed Contact PI's performance under Federal assistance agreements initiated within the last three years that were similar in size and scope to the proposed project.

The specific information required for each agreement is shown below, and must be provided within three weeks of EPA's request. A maximum of three pages will be permitted for the response; excess pages will not be reviewed. Note: If no prior past performance information and/or reporting history exists, you will be asked to so state.

1. Name of Granting Agency.

2. Grant number.

3. Grant title.

4. Brief description of the grant.

5. A description of how the agreement is similar in size and scope to the proposed project and whether or not it was successfully managed and completed; if not successfully managed and completed, provide an explanation.

6. Information relating to the proposed /Contact PI's past performance in reporting on progress towards achieving the expected results (outputs/outcomes) under the agreement. Include the history of submitting timely progress/final technical reports, describe how progress towards achieving the expected results was reported/documented, and if such progress was not being made, provide an explanation of whether, and how, this was reported.

7. Total (all years) grantdollar value.

8. Project period.

9. Technical contact (project officer), telephone number, and Email address (if available).

The purpose of the programmatic review is to ensure an integrated research portfolio for the Agency and help determine which applications to recommend for award. In conducting the programmatic review, the EPA will consider information provided by the applicant and may consider information from other sources, including prior and current grantors and agency files.

The EPA internal programmatic review panel will assess:

1. The relevance of the proposed science to EPA research priorities.

2. The proposed Contact PI's past performance [under Federal agency assistance agreements (assistance agreements include grants and cooperative agreements but not contracts) initiated within the last three years that were similar in size and scope to the proposed project] in two areas: First, in successfully managing and completing these prior Federal assistance projects, including whether there is a satisfactory explanation for any lack of success. Second, in reporting progress toward achieving results under these agreements, including the proposed Contact PI's history of submitting timely progress/final technical reports that adequately describe the progress toward achieving the expected results (outputs/outcomes) under the agreements. Any explanation of why progress toward achieving the results was not made will also be considered. Applicants whose proposed Contact PI has no relevant past performance and/or reporting history, or for whom this information is not available, will be evaluated neither favorably nor unfavorably on these elements.

EPA considers relevance more important than the Contact PI s past performance.

EPA Human Subjects Research Statement (HSRS) Review

Applications being considered for funding after the EPA Programmatic Review that involve human subjects research studies will have their HSRS reviewed by EPA’s Human Subjects Research Review Official (HSRRO) prior to award. The HSRRO will review the information provided in the HSRS and the Research Plan to determine if the ethical treatment of human subjects is described in a manner appropriate for conditional approval to be granted.

Final EPA funding decisions are made by the NCER Director based on the results of the peer review, the internal programmatic review and, where applicable, the EPA HSRRO’s assessment of the applicant’s HSRS (see Section IV). In addition, in making the final funding decisions, the NCER Director may also consider program balance and available funds. Applicants selected for funding will be required to provide additional information listed below under Award Notices. The application will then be forwarded to EPA’s Grants and Interagency Agreement Management Division for award in accordance with the EPA’s procedures.

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

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

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

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

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

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

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

Not Applicable.

For EPA, the official notification of an award will be made by the Agency’s Grants and Interagency Agreement Management Division. Applicants are cautioned that only a grants officer is authorized to bind the Government to the expenditure of funds; preliminary selection by the NCER Director in the Office of Research and Development does not guarantee an award will be made.

Non-profit applicants that are recommended for EPA funding under this announcement are subject to pre-award administrative capability reviews consistent with Sections 8b., 8c. and 9d. of EPA Order 5700.8 - Policy on Assessing Capabilities of Non-Profit Applicants for Managing Assistance Awards (http://www.epa.gov/ogd/grants/award/5700_8.pdf). In addition, non-profit applicants that qualify for funding may, depending on the size of the award, be required to fill out and submit to the Grants Management Office the Administrative Capabilities Form with supporting documents contained in Appendix A of EPA Order 5700.8.

Disputes related to this assistance agreement competition will be resolved in accordance with the dispute resolution procedures set forth in 70 FR 3629, 3630 (January 26, 2005) which can be found at http://www.epa.gov/ogd/competition/resolution.htm. Questions regarding disputes may be referred to the Eligibility Contact identified below.

Expectations and responsibilities of EPA/NCER grantees are summarized in this section, although the terms grant and grantee are used. See http://www.epa.gov/ncer/guidance for the full terms and conditions associated with an award, including which activities require prior approval from the EPA.

a. Meetings: Principal Investigators will be expected to budget for, and participate in, All-Investigators Meetings (also known as progress reviews) approximately once per year with EPA and NIEHS scientists and other grantees to report on research activities and discuss issues of mutual interest.

b. Approval of Changes after Award: Prior written approval of changes may be required from EPA. Examples of these changes are contained in 40 C.F.R. 30.25. Note: prior written approval is also required from the EPA Award Official for incurring costs more than 90 calendar days prior to award.

c. Human Subjects: A grant applicant must agree to meet all EPA requirements for studies using human subjects prior to implementing any work with these subjects. These requirements are given in 40 CFR 26. Studies involving intentional exposure of human subjects who are children or pregnant or nursing women are prohibited by Subpart B of 40 CFR 26. For observational studies involving children or pregnant women and fetuses please refer to Subparts C & D of 40 CFR 26. U.S. Department of Health and Human Services regulations at 45 CFR 46.101(e) have long required "... compliance with pertinent Federal laws or regulations which provide additional protection for human subjects." EPA’s regulation 40 CFR 26 is such a pertinent Federal regulation. Therefore, the applicant's Institutional Review Board (IRB) approval must state that the applicant's study meets the EPA's regulations at 40 CFR 26. No work involving human subjects, including recruiting, may be initiated before the EPA has received a copy of the applicant’s IRB approval of the project and the EPA has also provided approval. Where human subjects are involved in the research, the recipient must provide evidence of subsequent IRB reviews, including amendments or minor changes of protocol, as part of annual reports.

d. Animal Welfare: A grant recipient must agree to comply with the Animal Welfare Act of 1966 (P.L. 89-544), as amended, 7 U.S.C. 2131-2156. The recipient must also agree to abide by the "U.S. Government Principles for the Utilization and Care of Vertebrate Animals used in Testing, Research, and Training" (50 Federal Register 20864-20865. May 20, 1985).

e. Congress, through OMB, has instructed each federal agency to implement Information Quality Guidelines designed to "provide policy and procedural guidance...for ensuring and maximizing the quality, objectivity, utility, and integrity of information, including statistical information, disseminated by Federal agencies." The EPA's implementation may be found at http://epa.gov/quality/exmural.html#genreqts. These procedures may apply to data generated by grant recipients if those data are disseminated as described in the Guidelines.

The Office of Management and Budget (OMB) Circular A-110 located at 2 CFR Part 215 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with federal funds and (2) cited publicly and officially by a federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. If such data are requested by the public, the EPA must ask for it, and the grantee must submit it, in accordance with A-110 and the EPA regulations at 40 C.F.R. 30.36.

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.

An EPA grant recipient is expected to manage assistance agreement funds efficiently and effectively and make sufficient progress towards completing the project activities described in the research plan in a timely manner. The assistance agreement will include terms/conditions implementing this requirement.

A grant recipient must agree to provide annual progress reports, with associated summaries, and a final report with an executive summary. The executive summary will be posted on EPA/NCER’s website.

A grant recipient must agree to provide copies of any peer reviewed journal article(s) resulting from the research during the project period. In addition, the recipient should notify the EPA Project Officer of any papers published after completion of the grant that were based on research supported by the grant. NCER posts references to all publications resulting from a grant on the NCER web site.

Acknowledgement of EPA Support: EPA’s full or partial support must be acknowledged in journal articles, oral or poster presentations, news releases, interviews with reporters and other communications. Any documents developed under this agreement that are intended for distribution to the public or inclusion in a scientific, technical, or other journal shall include the following statement or another as specified by EPA’s project officer:

This publication [article] was made possible by EPA grant number _______. Its contents are solely the responsibility of the grantee and do not necessarily represent the official views of the EPA. Further, the EPA does not endorse the purchase of any commercial products or services mentioned in the publication.

A graphic that may be converted to a slide or used in other ways, such as on a poster, is located at http://epa.gov/ncer/guidance/star_images.html. EPA expects recipients to use this graphic in oral and poster presentations.

Subaward and Executive Compensation Reporting: Applicants must ensure that they have the necessary processes and systems in place to comply with the sub-award and executive total compensation reporting requirements established under OMB guidance at 2 CFR Part 170, unless they qualify for an exception from the requirements, should they be selected for funding.

Central Contractor Registration (CCR) and Data Universal Numbering System (DUNS) Requirements: Unless exempt from these requirements under OMB guidance at 2 CFR Part 25 (e.g., individuals), applicants must:

1. Be registered in the CCR prior to submitting an application or proposal under this announcement. CCR information can be found at https://www.bpn.gov/ccr/

2. Maintain an active CCR registration with current information at all times during which it has an active Federal award or an application or proposal under consideration by an agency, and

3. Provide its DUNS number in each application or proposal it submits to the agency. Applicants can receive a DUNS number, at no cost, by calling the dedicated toll-free DUNS Number request line at 1-866-705-5711, or visiting the D&B website at: http://www.dnb.com.

If an applicant fails to comply with these requirements, it will, should it be selected for award, affect their ability to receive the award.

EPA Pre-Application Assistance and Communications: In accordance with EPA's Assistance Agreement Competition Policy (EPA Order 5700.5A1), EPA staff will not meet with individual applicants to discuss draft proposals, provide informal comments on draft proposals, or provide advice to applicants on how to respond to ranking criteria. Applicants are responsible for the contents of their applications/proposals. However, consistent with the provisions in the announcement, EPA will respond to questions from individual applicants regarding threshold eligibility criteria, administrative issues related to the submission of the proposal, and requests for clarification about the announcement. In addition, if necessary, EPA may clarify threshold eligibility issues with applicants prior to making an eligibility determination.

Website References in FOA: Any non-federal websites or website links included in this FOA are provided for proposal preparation and/or informational purposes only. U.S. EPA does not endorse any of these entities or their services. In addition, EPA does not guarantee that any linked, external websites referenced in this FOA comply with Section 508 (Accessibility Requirements) of the Rehabilitation Act.

Unpaid Federal Tax Liabilities and Felony Convictions for Non-Profit and For-Profit Organizations: EPA Awards made under this announcement are subject to the provisions contained in the Department of Interior, Environment, and Related Agencies Appropriations Act, 2012, HR 2055, Division E, Sections 433 and 434 regarding unpaid federal tax liabilities and federal felony convictions. These provisions prohibit EPA from awarding funds made available by the Act to any for-profit or non-profit organization: (1) subject to any unpaid Federal tax liability that has been assessed, for which all judicial and administrative remedies have been exhausted or have lapsed, and that is not being paid in a timely manner pursuant to an agreement with the authority responsible for collecting the tax liability; or (2) that was convicted (or had an officer or agent of such corporation acting on its behalf convicted) of a felony criminal conviction under any Federal law within 24 months preceding the award, unless EPA has considered suspension or debarment of the corporation, or such officer or agent, based on these tax liabilities or convictions, and determined that such action is not necessary to protect the Government's interests. Non-profit or for-profit organizations that are covered by these prohibitions are ineligible to receive an award under this announcement.

Exchange Network: EPA, states, territories, and tribes are working together to develop the National Environmental Information Exchange Network, a secure, Internet- and standards-based way to support electronic data reporting, sharing, and integration of both regulatory and non-regulatory environmental data. States, tribes and territories exchanging data with each other or with EPA, should make the Exchange Network and the Agency's connection to it, the Central Data Exchange (CDX), the standard way they exchange data and should phase out any legacy methods they have been using. More information on the Exchange Network is available at www.exchangenetwork.net.

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

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

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

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: [email protected]

Kimberly Ann Gray, Ph.D.
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-0293
Email: [email protected]

Richard Callan, MPH
US Environmental Protection Agency (EPA)
Telephone: 703-347-8051
Email: [email protected]

Nica Louie, MS
US Environmental Protection Agency (EPA)
Telephone: 703-347-8125
Email: [email protected]

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

Linda Bass, Ph.D.
National Institute of Environmental Health Sciences (NIEHS)
Telephone: (919) 541-1307
Email: [email protected]

Donald Ellis
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-1874
Email: [email protected]

James Gentry
US Environmental Protection Agency (EPA)
Telephone (703) 347-8093
Email: [email protected]

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

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

The EPA authority for this FOA and resulting awards is contained in the Safe Drinking Water Act, Section 1442, 42 U.S.C. 300j-1; the Toxic Substances Control Act, Section 10, 15 U.S.C. 2609; the Federal Insecticide, Fungicide, and Rodenticide Act, Section 20, 7 U.S.C. 136r; the Clean Air Act, Section 103, 42 U.S.C. 7403; the Clean Water Act, Section 104, 33 U.S.C. 1254; and the Solid Waste Disposal Act, Section 8001, 42 U.S.C. 6981. For research with an international aspect, the above statutes are supplemented, as appropriate, by the National Environmental Policy Act, Section 102(2)(F).

Applicable EPA regulations include: 40 CFR Part 30 (Uniform Administrative Requirements for Grants and Agreements with Institutions of Higher Education, Hospitals, and Other Non-Profit Organizations), 40 CFR Part 31 (Uniform Administrative Requirements for Grants and Cooperative Agreements to State and Local Governments) and 40 CFR Part 40 (Research and Demonstration Grants). Applicable OMB Circulars include: OMB Circular A-21 (Cost Principles for Educational Institutions) relocated to 2 CFR Part 220 (http://www.access.gpo.gov/nara/cfr/waisidx_08/2cfr220_08.html), OMB Circular A-87 (Cost Principles for State, Local and Indian Tribal Governments) relocated to 2 CFR Part 225 (http://www.access.gpo.gov/nara/cfr/waisidx_10/2cfr225_10.html), and OMB Circular A-122 (Cost Principles for Non-Profit Organizations) relocated to 2 CFR Part 230 (http://www.access.gpo.gov/nara/cfr/waisidx_07/2cfr230_07.html).