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U.S. Environmental Protection Agency
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In cooperation with the National Institute of Environmental Health Sciences

CLOSED - FOR REFERENCES PURPOSES ONLY

Centers for Children's Environmental Health and Disease Prevention Research

Opening  Date:  September 25, 2000
Letter of Intent Receipt Date: November 1, 2000
Closing Date:  January 8, 2001

Purpose
Description of Currently Funded Centers
EPA Children’s Environmental Health Initiative
Public Health Service’s Healthy People 2010
Research Objectives
Funds Available
Eligibility Requirements
Special Requirements
Inclusion of Women and Minorities in Research Involving Human Subjects
Inclusion of Children as Participants in Research Involving Human Subjects
URLs in Grant Applications or Appendices
Letter of Intent
Application Procedures
Review Considerations
Award Criteria
Mechanism of Support
Authority and Regulations
Inquiries

PURPOSE

The U.S. Environmental Protection Agency and the National Institute of Environmental Health Sciences (NIEHS) share the common objective of fostering research that will ultimately reduce the extent of adverse human health effects occurring as a consequence of exposure to hazardous environmental agents.  The agencies recognize that these health impacts can be particularly detrimental for children due to pronounced differences in nature and extent of environmental exposure as well as in functional development when compared to adults.  A Federal Executive Order of April 21, 1997, "Protection of Children from Environmental Health Risks and Safety Risks," charges agencies to consider special environmental risks to children in their activities.  Accordingly, EPA and NIEHS invite grant applications for new Centers that will conduct multidisciplinary basic and applied research in combination with community-based research projects to support studies on the causes and mechanisms of children's developmental disorders with special emphasis on environmental exposures which may put children at risk of these disorders.

These research Centers will develop innovative strategies to measure relevant environmental exposures in children, and conduct research to reduce hazardous exposures and their adverse health effects, and eventually decrease the prevalence, morbidity, and mortality of environmentally related childhood diseases.  The purpose of awards in this program of Centers for Children's Environmental Health and Disease Prevention Research is to:

  • Provide for multidisciplinary interactions among basic, clinical, and behavioral scientists interested in establishing outstanding, state-of-the-art research programs addressing environmental contributions to children's health and disease.

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  • Support a coordinated program of research/prevention Centers pursuing high quality research in environmental aspects of children's disease, with the ultimate goal of facilitating and accelerating translation of basic science knowledge into clinical applications or intervention strategies that can be used to reduce the incidence of environmentally related diseases in childhood.

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  • Develop fully coordinated programs that incorporate exposure assessment and health effects research with development and validation of risk management and health protection strategies.

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  • Establish a national network that fosters communication, innovation, and research excellence with the ultimate goal of reducing the burden of morbidity among children as a result of exposure to harmful environmental agents.
    • This initiative will focus on the impact of environmental exposures on the etiology and prevention of developmental disorders in children.  Data will be generated in a multitude of scientific disciplines in order to understand the impact of chemical and other exposures on the fetus and child as they relate to brain and organ system development, growth and development of the child through young adulthood, and neurobehavioral outcomes which have public health importance in children.

    This initiative builds upon a related Request for Applications (RFA), which resulted in creation in 1998, of eight Centers for Children's Environmental Health and Disease Prevention Research (see below).  The prior RFA emphasized three research foci: respiratory disorders; growth and development; learning and behavior.  The present initiative will support new Centers, specifically addressing developmental disorders.

    Expansion of the existing program will provide for additional Centers which focus on the rising prevalence and incidence of cognitive, motor, sensory, and behavioral impairments in children and the environmental exposures of children which may put them at risk of these disorders.

    The long-range goals of this program are twofold: to stimulate new research on the role of environmental exposures in the etiology and prevention of developmental disorders in children,  and to promote translation of basic research findings into applied intervention and prevention methods, thereby enhancing awareness among children, their families, and health care practitioners regarding detection, treatment, and prevention of environmentally related diseases and health conditions.  In this regard, it is required that each Center have a community-based participatory research project which capitalizes on partnerships between researchers and community-based organizations, including local affiliates of organizations which provide support and education for families with children with developmental disabilities (e.g. March of Dimes, National Alliance for Autism Research and The Arc of the United States.)  Each Center should create a structure to carry out research which is of importance to the affected community.  This work can be community-based etiologic research, community-based exposure assessment research, or community-based prevention/intervention research.

    Each application is to be designed around a central scientific theme, specifically examining the  role of environmental agents in the etiology of developmental disorders and design of strategies to prevent them.  The application must contain a minimum of two basic biomedical research projects and one community-based participatory research project.  These projects must include at least two of the three scientific disciplines encompassed by this initiative: mechanistic research, epidemiologic research or exposure assessment research.

    DESCRIPTION OF THE CURRENTLY FUNDED NETWORK OF CHILDREN’S ENVIRONMENTAL HEALTH CENTERS

    In 1998, US EPA and NIEHS/NIH funded eight universities to initiate this program.  Four of the Centers are studying the relationship between indoor and outdoor air pollutants and childhood asthma.  The other centers are studying the effects of pesticide exposure both in agricultural and inner city settings on growth and development of children.  More information about the existing program can be found at  http://www.niehs.nih.gov/dert/programs/translat/children/children.htm.

    EPA CHILDREN'S ENVIRONMENTAL HEALTH INITIATIVE

    At EPA children's environmental health issues are a top priority and have become a central focus of the agency's efforts.  This RFA is a component of the agency's overall initiative that, together with the efforts of partner agencies, will ensure that children receive the protection they need and deserve and help our nation fulfill its obligation to protect future generations.  Potential applicants may obtain a copy of the EPA's national agenda to protect children's health from environmental threats (EPA 175-F-96-001) at http://www.epa.gov/epadocs/child.htm.

    PUBLIC HEALTH SERVICE’S HEALTHY PEOPLE 2010

    The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas.  This Request for Applications (RFA), "Centers for Children's Environmental Health and Disease Prevention Research," is related to the priority area of Environmental Health.  Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/.

    RESEARCH OBJECTIVES

    Background

    The current initiative continues EPA’s and NIEHS’ intent  to foster advancements in children's health through enhancing our understanding of health impacts of children’s contact with environmental chemicals and other exposures in the course of their daily lives by supporting the highest quality research on basic disease mechanisms and promoting community-based research/prevention activities.  Both agencies are interested in reducing risk to children and the societal burden of developmental and behavioral disorders or deficits in traits associated with such disorders by preventing hazardous environmental exposures at home, at school, and in the community.

    Collaborative, multidisciplinary research approaches are required to explore the dynamic interaction of children with their environment.  This Center program therefore emphasizes integration of basic laboratory science with applied community based participatory research (CBPR) strategies.  Because the latter are also research projects, it is important to note that each community based research project should include appropriate methodology for assessing its effectiveness (see 'Description of a Center' below).  Centers are expected to have fully coordinated programs that incorporate exposure assessment and health effects research with development and validation of risk management and health prevention strategies.  Moreover, involvement of the affected community in planning, implementing, and evaluating a CBPR effort is essential.  CBPR  not only expands our understanding of the causes and remedies of environmentally related disorders, but also enhances the capacity of communities to participate in processes that shape research and intervention approaches.  By bridging gaps between basic and applied researchers and between institutional researchers and community members, this program aims to improve our knowledge regarding detection, treatment, and prevention of environmentally related diseases in children.

    A Center should identify a central theme or focus of its research effort so that the subprojects involved are responsive to the specific research area of children's environmental health supported by this grant program.  Furthermore, the translational objective of this program requires the applicant to include at least one sub project which includes research of a community-based  participatory nature.

    Research Scope

    There is growing evidence suggesting that the daily challenges associated with productive participation in school and community life are becoming unusually difficult for an increasing number of our nation’s children (Schettler T, Stein J, et al, "In Harm’s Way: Toxic Threats to Child Development, 2000" http://www.igc.org/psr).  More and more children struggle with learning, participation in social groups, self-control and self-regulation issues, and face physical challenges involving  gross and fine motor skills.  The number of children nation-wide receiving special educational and other services has increased dramatically.  Over the period 1977-1994,  the number of children receiving services for learning disabilities has nearly doubled.  It is now estimated that approximately 12 million children, or 17% of the U.S. population under 18, have one or more learning, behavioral or developmental disabilities.  Attention deficit hyperactivity disorder affects 3-6% of school-aged children; some investigators have reported prevalence estimates as high as 17%.  There have been dramatic increases in the numbers of children diagnosed with  autism and other pervasive developmental disorders, an increase of 210% in the California registry between 1987-1998.  Although new programs have been developed to identify and serve  the needs of these children, the causes of these learning behaviors and developmental challenges are not known.  Past efforts have focused on understanding the causes of structural deficits and malformations, some of the most severe developmental disorders.  Little attention has been paid to the causes of functional deficits, those changes in learning, behavior, and development which compromise a child’s ability to function adequately in society.

    The causes of developmental disorders and the associated spectrum of deficits in traits which make up the disorders are the results of a complex web of interactions between genetic, neurochemical, biochemical, environmental, and social factors that influence children during critical periods of development.  Toxic stressors during development may produce physiological changes which have lifelong effects on children’s physical and mental health.  For instance, brain development begins before birth and continues through adolescence and young adulthood.  During specific time windows, the brain receives different types of information which is essential for continued development.  Alterations in this information will influence how and to what extent different functional areas develop within the brain and other organs and how they will impact physical and mental health of the human.  In order to understand these complex processes, the knowledge base on the extent of and timing of children’s exposures to chemicals and other toxicants in the environment, factors that modify their effects, and the subsequent health outcomes needs to be greatly expanded.

    Evidence from animal studies has been accumulating on the neurotoxic and developmental effects of a variety of chemicals and metals that commonly occur in our environment.  Because of the unique sensitivity and vulnerability of children, their biologically relevant exposures may be higher than adults and hence subtle functional attributes may be affected by such exposures.  It is well known that lead is neurotoxic in children and has been shown to be responsible for decrements in IQ and intellectual functioning in many cohorts around the world.  The behavioral consequences of these exposures, such as attention deficits, increased impulsiveness, overall reduced school performance, aggression, and violent behavior are less well studied, but worthy of further attention.  Children’s exposure to methyl mercury has been implicated in language, memory and attention impairments, all of which may be related to school performance and ability to function in society.  Manganese, important in many endogenous enzymatic processes,  is less-known as a neurotoxicant.  Yet animal studies point to the plausibility of exposure to metals as causal agents in hyperactivity or learning disabilities.  Many forms of pesticides may  pose a significant hazard to children since animal studies have shown that small single doses of organophosphorus and pyrethroid insecticides in a critical window of development may cause hyperactivity and changes in neurotransmitter levels in the brain.  Other classes of pesticides may cause decreases in DNA synthesis and cell death in vital regions of the brain.  More work in populations of children exposed to these agents is needed in order to corroborate these findings in humans.  Similar effects may also be attributable to solvent exposure during pregnancy.  Exposures to dioxins and PCBs continue to be of interest since they bioaccumulate and are persistent in children during a period of rapid growth and development.  Endocrine disrupting chemicals may be related to changes in the timing of pubertal development in boys and girls, and may affect later reproductive health in adulthood.  Additional work using appropriate animal models is necessary to further our understanding of these effects, as is new work in human populations with unique exposures.

    Over the past three years, NIEHS and EPA have supported and conducted a series of workshops to review the state of the science and form recommendations for creating a research agenda for understanding the role of environmental agents and their modifying factors as possible causes for developmental disorders or functional deficits in children.  These workshops have identified opportunities for future research which include basic mechanistic research to understand the underlying structural and functional pathology of these disorders; expansion of neurodevelopmental toxicology and behavioral neurotoxicology; broadening our understanding of the critical periods of development and the timing and mechanisms by which neurotoxic chemicals may act to contribute to these disorders in children; and gaps in our knowledge related to exposure assessment in children.  These meetings are listed below with a website link to the proceedings published for the first three in Environmental Health Perspectives, Volume 108, Supplement 3, June 2000 (http://ehpnet3.niehs.nih.gov/docs/2000/suppl-3/toc.html).

    The EPA and NIEHS are very interested in the effects of a variety of hazardous chemical agents on the growth and development of the fetus and child though young adulthood.  These include: pesticides, such as organophosphates, triazines, and pyrethroids; chemicals which exhibit endocrine disrupting effects, including phthalates, PCBs, and dioxins; metals, including lead, mercury, arsenic, and manganese; solvents; polycyclic aromatic hydrocarbons; environmental tobacco smoke and particulates; and other chemical air pollutants.  Other factors which affect the early environment of children, such as social and emotional factors, nutritional status, and socioeconomic variables should also be included as important components of the proposed research.  Research which addresses the interaction between social factors and physical environmental factors is encouraged.

    For the purposes of this RFA, neurobehavioral and behavioral disorders can include (but are not limited to): mental retardation, learning disabilities, cerebral palsy, autism and pervasive developmental disorders; visual and hearing impairments; attention deficit and hyperactivity disorders; and antisocial conduct and other behavioral disorders.  Research on specific delays and impairments in cognitive, fine and gross motor and sensory function, language development, self-regulation and control, and social participation is appropriate.  Also included is growth and development of children, including overall size and stature, specific organ growth and function, and the regulations of hormonal and growth factors important in development.  Puberty and sexual maturation in children is of particular interest.  Basic research on the pathophysiology, molecular biology, and clinical characteristics of these disorders is appropriate if it is well integrated into the overall theme of the Center.

    The following specific topics are examples of research areas that will be suitable, for purposes of the current RFA.  Other research topics should be discussed with program staff listed in the INQUIRIES section of this RFA.

    Mechanistic neurodevelopment and neurotoxicology of the fetus and growing child
    Population Based Studies Exposure Assessment in Children Community Based Participatory Research
    Description of a Center

    A Center for Children’s Environmental Health and Disease Prevention Research provides the opportunity for investigators to engage in interdisciplinary and collaborative research directed toward a central theme. Research should be planned to investigate gaps in knowledge about developmental disorders and associated deficits in cognitive, motor, sensory and behavioral traits and the effects of exposures to environmental agents during critical windows of development including gestation, early childhood, and adolescence.

    All applicants must form a partnership with a community-based or other organization, including those which provide support and education to families with children with developmental disorders, in order to include a CBPR project within the Center.  The foundation of the CBPR should be strongly linked to the basic science research within the Center.  In situations where linkages between environmental exposures and developmental endpoints are known or strongly suggested based on previous research, intervention programs to reduce the exposures and show tangible improvements in physiologic or psychologic endpoints should be included in the application.  In situations where these linkages are not firmly established in human populations but may be biologically plausible based on experimental or wildlife research, community driven participatory research can be proposed which seeks to describe levels of environmental contaminants in the community or health effects about which the community is concerned.  The basic science studies should be driven by the needs of the community-based research project.  In addition, a Center may include facility and administrative core units to provide services to the various research projects and to support the organizational and administrative aspects of the program.

    The minimal requirements for a Center for Children's Environmental Health and Disease Prevention Research are as follows:

    Each Center will propose an overall research mission and plan that is responsive to the objectives of the Center Program set forth in the RFA (see Research Objectives above).

    Each Center will support at least two basic research projects and one community based participatory research project.  These three projects must be chosen from at least two of the following three disciplines:

    Basic research projects should include mechanistic studies of environmental agents which contribute to adverse health outcomes in children as well as research which will improve our basic understanding of pathophysiology, molecular genetics, or cell biology of the developmental processes of interest.  Basic mechanistic research pertaining to the central theme may fall into any of the following disciplines: toxicology, cell and molecular biology,  physiology, psychology, and genetics or other relevant fields.  These projects  may include methods using animal models, in vitro systems, and/or human clinical specimens.  Epidemiologic research should focus on exploring the plausibility of environmental contributors and other risk factors for specific developmental disabilities or their associated traits.  Population-based research which explores genetic susceptibility using methods which incorporate gene and environmental interactions while quantifying risk is also encouraged.  Novel approaches to exposure assessment in exposed and affected children across the life span are greatly encouraged.  Development of, and enhancements to, state of the art approaches to direct and indirect measurements of exposure to toxic chemicals in children are desired.  Studies focusing on characterizing pathways of exposure; the magnitude, frequency, duration and time-pattern activities which lead to contact in children; and quantifying contact rates of children with exposure media, contaminant transfer efficiencies and uptake rates in children are all considered  important advances in this field.  Interactions between investigators responsible for basic research and community-based  research projects are expected to strengthen the research, enhance transfer of fundamental findings to an applied setting, and identify new research directions.  (It is anticipated that a Center will devote 30-45% of its budget to basic research projects.)

    Each Center must support one project that develops, implements, and evaluates a CBPR project related to the central theme of the Center.  These projects can be proposed in the following areas: community-based etiology studies of health concerns; community-based exposure assessment; and community based prevention/intervention  research.  It is a requirement of this program that academic researchers work together with community-based organizations, broadly defined to include environmental justice groups, church coalitions, parent-teacher associations, or other such groups who have organized around environmental or health concerns of the community.  Working with local affiliates of regional or national disease-based organizations in identifying research concerns is also appropriate.  Applications lacking a demonstrable linkage to a community-based or local disease-based organization will be considered non responsive.

    It is expected that Centers working in areas where exposure-disease linkages are well established will propose intervention/prevention activities which seek to reduce exposures in the environment and subsequently reduce body burden and impact on the disease or its associated functional deficits.  CBPR research should be placed within the appropriate public health context.  For those Centers working in newer areas trying to establish exposure-disease linkages, the CBPR project can be related to etiology or exposure assessment related to community concerns.

    It is important to note that this CBPR project must specifically address all of the following parameters: (a) scientific basis of the proposed research and the hypothesis to be tested; (b) sample size needed, power considerations, procedures for sample selection, and recruitment and retention of a study population; (c) detailed description of a research design for the proposed intervention or etiologic or exposure assessment study; (d) measurement instruments and their reliability and validity, considering both process and outcome evaluation; (e) data management and analysis methods; (f) identification and description of target community and known environmental health hazards; (g) means of establishing effective interaction and collaboration with community members.  Because this project is intended to be community-based, the application must demonstrate a specific, existing linkage to a community-based organization and specific involvement of community members in development, conduct, and interpretation of the intervention.  EPA and NIEHS recognize that local health departments often play an important role in delivering public health services to the community.  Therefore, applicants are also encouraged to consider including local, county, or state health departments in the proposed intervention research project.  However, involvement of a local health department will not substitute for the required community-based organization.

    Activities conducted under this RFA should be consistent with Federal Executive Order No. 12988 entitled, "Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations", when appropriate.  To the extent practicable and permitted by law, grantees shall make achieving environmental justice part of their project's mission by identifying and addressing, as appropriate, disproportionately high and adverse human health effects of environmental contaminants on minority, low-income, and medically underserved children, including but not limited to, African, Hispanic, Asian, and Native Americans. (It is anticipated that a Center may devote 20-35% of its budget to one community-based participatory research project.)

    Each Center may support facility cores that provide a technique, service, or instrumentation that will enhance ongoing research efforts. Examples of such facilities are animal resources, cell/tissue culture, pathology, biostatistics, molecular biology, neuropsychology, neuroimaging, analytical chemistry, exposure assessment, survey analysis, etc.  It should be noted that exposure assessment as a service within a facility core differs in depth and scope from the basic research of an exposure assessment research project.  An exposure assessment facility core supports the measurement aspects of an epidemiologic or other field study by collecting specimens and measuring chemical analytes or other biomarkers of exposure to assess environmental levels or human body burden of exposures of interest.  This core should be involved in quality assurance and quality control aspects of exposure analysis activities.  (Exposure assessment research activities are described in Description of the Center section.)

    Budgeted Center projects as well as research projects external to the Center may have access to facility cores.  The application should provide a total operational budget for each facility core together with the percentage of support requested from the Center grant.  In addition, the Center must have in place and adequately described in the application management policies which ensure that budgeted Center projects are given highest priority in receiving services provided by the facility core.  The application should explain the organization and proposed mode of operation of each core, including a plan for usage, priority setting, allocation of resources, and any applicable charge back system. (It is anticipated that a Center will devote 10-20% of its budget to facility cores.)

    An administrative core unit must provide overall oversight, coordination, and integration of  Center activities.  An External Advisory Committee to the Center Director must be established.  This group should consist of a group of three to five scientists having expertise appropriate for the Center's research focus, plus one representative from a community-based organization involved in community-based research.  Representation from a state or local health department is also encouraged.  At least 67% of Committee members should be from outside the grantee institution. The membership of the advisory committee must be approved by the funding agency.  The function of this Committee is to assist in evaluating the merit, value, and contribution of research projects; the relevance and importance of individual organizational elements to accomplishing the overall goals of the Center; and the effectiveness of the newly recruited Center scientist program. (It is anticipated that a Center will devote 10-15% of its budget to an administrative core.)

    To attract new investigators into children's environmental health research, each Center is encouraged to partially support up to two newly recruited Center scientists.  Up to $70,000 per year, direct cost, may be used for each newly recruited Center scientist to provide up to 75% salary support, technical support, equipment, and supplies.  The duration of support as a newly recruited scientist is limited to two years.  Following termination of support as a newly recruited Center scientist, such an individual may, if appropriate, become or continue to be a part of a basic or community-based participatory research project and make use of Center facilities.  Recruitment of women and under-represented minority scientists is specifically encouraged.  To the extent possible, the types of individuals sought and their expected roles should be described in the application if specific individuals have not been identified. (It is anticipated that a Center will devote no more than 14% of its budget to recruitment of new scientists.)

    FUNDS AVAILABLE

    Although this solicitation is included in fiscal plans of EPA and NIEHS for FY 2001, support for these Center grants is contingent upon availability of funds for this purpose.  It is anticipated that an estimated total of $6 million, including direct and indirect costs, will be available for the first year of the program, which will support up to four Centers in FY 2001.  It is expected that NIEHS and EPA may solicit additional new Center applications in the future through subsequent issuance of a similar RFA addressing children's environmental health.

    ELIGIBILITY REQUIREMENTS

    Applications may be submitted by domestic non-profit organizations, public and private, that meet the requirements stated in this RFA.  Minority individuals, persons with disabilities, and women are encouraged to apply as Principal Investigators.  The need for communication and interaction among awarded sites dictates that only domestic institutions in the United States will be eligible for these Center grant awards.

    SPECIAL REQUIREMENTS

    Quality Assurance Statement:  For each research project involving data collection or processing, conducting surveys, environmental measurements, and/or modeling, provide a statement on quality processes that will be used to assure that results of the research satisfy the intended project objectives.  For awards that involve environmentally related measurements or data generation, a quality system that complies with the requirements of ANSI/ASQC E4, "Specifications and Guidelines for Quality Systems for Environmental Data Collection and Environmental Technology Programs," must be in place.  The Quality Assurance Statement should not exceed two pages.  This Statement should, for each item listed below, present the required information, reference the specific page and paragraph number of the project description containing the information, or provide a justification as to why the item does not apply to the proposed research.

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

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

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

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

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

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

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

    Successful Center award recipients must complete an overall Center Quality Management Plan  (QMP) which is a detailed policy statement describing the management and technical activities necessary to plan, implement, and assess the effectiveness of quality assurance and quality control within the Center.  Instructions for preparation of the QMP will be provided at the time of award.

    Annual meetings:  Annual meetings will be held for the exchange of information among investigators.  Applicants must budget travel costs associated with these meetings for the Principal Investigator and each project director in their applications.  For budgeting purposes assume that meetings will be held in Washington, DC, or Research Triangle Park, NC.

    Information Exchange:  Since these Centers include community-based research, applicants are expected to maximize opportunities for information exchange between institutional researchers and community members.  As part of this program, applicants must generate a report that describes community input, program implementation, and relevant findings.  This report must be produced at least annually and distributed among community members in such a way that it can be easily comprehended by the public.  Applicants must budget for production and dissemination of such reports.  This requirement is intended to establish a minimal level of communication among project participants; additional, more frequent dissemination efforts may be appropriate.

    INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN
    SUBJECTS

    Women and members of minority groups and their subpopulations must be included in all biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research.  This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43.)

    All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which was published in the Federal Register of March 28, 1994 (FR 59:14508-14513) and is available on the web at http://grants.nih.gov/grants/guide/notice-files/not94-100.html.

    INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

    It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.  This policy applies to all initial applications submitted for receipt dates after October 1, 1998.

    All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines: on the Inclusion of Children as Participants in Research Involving Human Subjects that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html.
    Investigators may also obtain copies of these policies from the program staff listed under INQUIRIES.  Program staff may also provide additional relevant information concerning the policy.

    URLS IN GRANT APPLICATIONS OR APPENDICES

    All applications and proposals must be self-contained within specified page limitations.  Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites.  Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site.

    LETTER OF INTENT

    Prospective applicants are asked to submit a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted.  Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains allows EPA and NIEHS staff to estimate potential review workload and to plan the review.

    The letter of intent is to be sent by the letter of intent receipt date listed to:

    Linda Bass, Ph.D.
    Scientific Review Administrator
    Scientific Review Branch
    Division of Extramural Research and Training
    National Institute of Environmental Health Sciences
    P.O. Box 12233, EC-24
    111 T. W. Alexander Drive
    Research Triangle Park, NC 27709

    Telephone: 919-541-1307
    Fax: 919-541-2503
    E-mail: bass@niehs.nih.gov

    APPLICATION PROCEDURES

    The research grant application form, PHS 398 (rev. 4/98) is to be used in applying for these grants.  These forms are available at most institutional offices of sponsored research and from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301-435-0714, EMail: GrantsInfo@nih.gov

    Content of Applications

    A response to this RFA should consist of an application that includes a detailed description of a Center for Children’s Environmental Health and Disease Prevention Research, consisting of at least two individual basic research projects, a community-based participatory research project, an administrative core, up to two newly recruited Center scientists, and, if applicable, one or more facility cores.  The proposed research plan should present the applicant's perception of the Center's organization and component functions.  This plan should demonstrate the applicant's knowledge, ingenuity, practicality, and commitment in organizing a multi-project research infrastructure for conducting basic and applied studies in children's environmental health sciences.  The research plan for the Center and all component projects must address the "Research Scope" described earlier.

    For individual projects or cores, page limits stated in the PHS 398 instructions must be followed.  The overall Center application must also use the PHS 398 format to provide at the beginning of the application an overall summary of the Center's organization and cumulative aggregate budgeting for various research subprojects and cores.  All information essential for evaluation of the application must appear in the body of the application rather than in an appendix.

    The RFA label available in the PHS 398 (rev. 4/98) application form must be affixed to the bottom of the face page of the application.  Type the RFA number on the label.  Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review.  In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be checked.

    The sample RFA label is available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf, and has been modified to allow for this change.  Please note that this is in pdf format.

    To simplify administration of this joint EPA/NIEHS initiative, 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
    BETHESDA, MD  20817 (for express/courier service)

    At the time of submission, three additional copies of the application must be sent to:

    Linda Bass, Ph.D.
    Scientific Review Administrator
    Scientific Review Branch
    Division of Extramural Research and Training
    National Institute of Environmental Health Sciences
    P.O. Box 12233, EC-24
    111 T. W. Alexander Drive,
    Research Triangle Park, NC 27709

    Telephone: 919-541-1307
    Fax: 919-541-2503
    E-mail: bass@niehs.nih.gov

    Applications must be received by the application receipt date listed in the heading of this RFA.  If an application is received after that date, it will be returned to the applicant without review.

    The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application.  The CSR will not accept any application that is essentially the same as one already reviewed.  This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique.

    REVIEW CONSIDERATIONS

    Upon receipt, applications will be reviewed for completeness by the CSR and for responsiveness to the RFA by NIEHS and EPA staff.  Incomplete and/or non-responsive applications will be returned to the applicant without further consideration.  Any application that does not meet the minimum requirements as set forth in the 'Description of a Center' section of this RFA will be considered unresponsive to the RFA and returned to the applicant.  This includes, but is not limited to, an evaluation by EPA and NIEHS Staff of the program relevancy of the proposed basic research and community-based participatory research projects.

    Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIEHS and the EPA in accordance with the review criteria stated below.  As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed, assigned a priority score, and receive a second level review by both EPA's National Center for Environmental Research (NCER) and the NIEHS National Advisory Environmental Health Sciences Council (NAEHSC).

    Review Criteria

    Evaluation of applications will be based upon the following:

    1.  Research Plan

    Scientific and technical merit of each proposed basic research project, including originality, feasibility, innovation, and adequacy of experimental design.

    Scientific and technical merit of the proposed community-based participatory research study, including the extent of community sanction, interaction, and participation.  Extent to which the design demonstrates sensitivity to cultural and socioeconomic factors in the community.  Demonstration of effective communication channels between institutional researchers and community members.  Plans for useful and practical dissemination of findings within the affected community.  Adequacy of statistical and analytical methods, data management, and process and outcome evaluation measures.

    Integration of basic and community based research into a coherent enterprise with adequate plans for interaction and communication of information and concepts among investigators.

    Cohesiveness and multidisciplinary scope of the Center as a whole.  Degree of interrelationships, collaboration, and synergism of research that might be expected to derive from Center support.  Coordination and interdependence of individual projects and their capacity to result in a greater contribution to the overall goals of the Center than if each were pursued independently.

    Adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research.  Plans for recruitment and retention of subjects will also be evaluated. (See INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS.)

    Appropriateness of policies to ensure the protection of human subjects and the humane care and use of laboratory animals.

    2.  Personnel
    Scientific, administrative, and leadership abilities of the Principal Investigator and other key participants, particularly, but not exclusively, in the area of the proposed research.  The Principal Investigator should be an established research scientist with the ability to ensure quality control and the experience to administer effectively and integrate all components of the Center.  A minimum time commitment of 25% is expected for this individual.

    Documented commitment of time by key personnel for the proposed studies.

    Procedures established for recruitment and evaluation of new Center scientists.  Evidence of efforts to develop novel mechanisms for recruiting candidates among women and under-represented minority investigators.  Potential of new Center Scientists to become independent investigators in clinical, basic, or community-based participatory research in children's environmental health.

    3.  Facilities and Management
    Adequacy of administrative and technical capabilities to conduct the research proposed.

    Scientific and organizational structure of the Center, including adequacy of arrangements for external review.

    Nature and quality of facility cores.  Technical merit, justification, cost effectiveness, qualifications of staff, utility to investigators, and arrangements for internal quality control, allocation of resources, priority of usage, and day-to-day management.

    Adequacy of animal facilities and appropriateness of animal care management where animal work is proposed.

    Adequacy of clinical facilities and appropriateness of patient care management where clinical work is proposed.  As appropriate, access to inpatient and outpatient children's health care units providing adequate numbers of patients for research projects that require patient participation. [Applications from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting proposed research.  In such a case, a letter of agreement from either the GCRC Program Director or Principal Investigator should be included with the application.]

    Institutional assurance to provide support to the Center in such areas as fiscal administration, personnel management, space allocation, procurement, planning, and budgeting.

    4.  Budgeting
    Appropriateness of the proposed budget and duration in relation to proposed research.
    Schedule

    The following is the schedule planned for this initiative.  It should be noted that this schedule may be changed without notification due to factors that were unanticipated at the time of the announcement.  Please contact the program official listed below regarding any changes in the schedule.

    Letter of Intent Receipt Date: November 1, 2000
    Application Receipt Date:  January 8, 2001
    Initial Review Group Peer Review:  March 2001
    NAEHS Council/NCER Review:  May 2001
    Earliest Award Date:  July 1, 2001

    AWARD CRITERIA

    The anticipated date of award is July, 2001.  Approved applications will be considered for award based on scientific and technical merit; program balance; and availability of funds.  Funding will be provided to each Center by a single award from either EPA or NIEHS or a combination of two separate awards.  Administrative and budgetary policies of EPA and NIEHS will apply to these awards.

    In order to receive funding, an individual domestic institution's application for a Children’s Environmental Health Center grant must have two or more related, interactive, and high quality research projects that provide a multidisciplinary, yet thematic, approach to the problems to be investigated.  Applicants must also include an additional project which is community-based and participatory in nature.  Awards for applications or components thereof proposing long-term (greater than five years) epidemiological or large-scale clinical trial research will not be made under any circumstances.

    MECHANISM OF SUPPORT

    The funding mechanisms to be used to assist the scientific community in participating in this grant program will be those of (1) the Environmental Protection Agency's Office of Research and Development, administered in accordance with 40 CFR Part 30 and 40, or (2) the National Institutes of Health (NIH) Program Project Grant (P01).  Policies that govern grant award programs of each agency will prevail for respective sources of support.  Support of grants pursuant to this RFA is contingent upon receipt of a sufficient number of applications of high scientific merit and of appropriated funds for this purpose.

    Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of the awards will also vary within the funding limits available (see Description of a Center).  The maximum award will be $1 million in direct costs in the first and all subsequent years for all new Centers.  Funding in subsequent  years is contingent upon satisfactory progress during the preceding year  and availability of funds.

    The total project period for an application submitted in response to this RFA may not exceed five years.  The anticipated award date is July, 2001.

    AUTHORITY AND REGULATIONS

    This program is described in the Catalog of Federal Domestic Assistance, Numbers 66.500, 93.113, 93.114 and 93.115.  EPA awards are made under the authority of 40 CFR Parts 30 and 40.  Awards by NIEHS are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grant policies and Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.  The program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review.

    The PHS and EPA strongly encourage all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products.  In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or, in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children.  This is consistent with the EPA and PHS missions to protect and advance the physical and mental health of the American people.

    INQUIRIES

    Inquiries concerning this RFA are encouraged.  The opportunity to clarify any issues or questions from potential applicants is welcome.

    Direct inquiries regarding programmatic issues to:

    Gwen W. Collman, Ph.D.
    Scientific Program Administrator
    Chemical Exposures and Molecular Biology Branch
    Office of Program Development
    Division of Extramural Research and Training
    National Institute of Environmental Health Sciences
    P.O. Box 12233, EC-21
    111 T.W. Alexander Drive
    Research Triangle Park, NC 27709
    Telephone: 919-541-4980
    FAX: 919-316-4606
    E-mail: collman@niehs.nih.gov

    Nigel Fields, M.S.P.H.
    National Center for Environmental Research
    U.S. Environmental Protection Agency (8723R)
    1200 Pennsylvania Ave., NW
    Washington, DC 20460
    Telephone: 202-564-6936
    FAX: 202-565-2448
    E-mail: fields.nigel@epa.gov

    Direct inquiries regarding fiscal matters to:

    Ms. Dorothy Duke
    Chief, Grants Management Branch
    Division of Extramural Research and Training
    National Institute of Environmental Health Science
    P.O. Box 12233, EC-22
    111 T.W. Alexander Drive
    Research Triangle Park, NC 27709
    Telephone: 919-541-1373
    FAX: 919-316-4606
    E-mail: duke5@niehs.nih.gov

    Mr. Jack Puzak
    Deputy Director
    National Center for Environmental Research
    U.S. Environmental Protection Agency (8701R)
    1200 Pennsylvania Ave., NW
    Washington, DC 20460
    Telephone: 202/564-6825
    FAX: 202/565-2444
    Email: puzak.jack@epa.gov

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